DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Set Issues
The prior Non-Final Office Action mailed 7 April 2026 was drawn to a claim set filed on 10 March 2025. Applicant contacted the examiner to draw attention to a preliminary amendment claim set filed on 2 May 2025. The 2 May 2025 claim set was filed on the same date as a voluminous set of IDS documents and was not initially categorized as a claim set for examination purposes. However, the matter has been corrected and the 2 May 2025 claim set has been entered. Accordingly, this Office Action is NON-FINAL.
Benefit
The application claims benefit as to US Provisional 63/655,439 (3 June 2024) and US Provisional 63/654,375 (31 May 2024) and which also claims benefit as a CIP of PCT/US2023/085868 (23 December 2023), which claims benefit to US Provisional 63/447,007 (23 December 2022).
Formal Matters
Claims 1-40 are cancelled. Claims 41-92 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 17 January 2025 (5x), 2 May 2025 (2x), 21 November 2025, and 17 February 2026 have been considered by the examiner. They were previously mailed to Applicant. The IDS submitted on 6 April 2026 has been considered by the examiner. A signed copy is attached.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112(b)
Claims 45 and 47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 45, recites the IVL catheter assembly according to claim 41, “wherein the polymer tube forms a port, which is to receive a guidewire, in a middle portion thereof.” It is unclear whether the port is intended to be in the middle portion of the polymer tube or whether it is the guidewire is to be received in a middle portion of the polymer tube. The metes and bounds of the phrase “in a middle portion thereof” is unclear and confusing due to the sentence construction and the punctuation in the claim.
Claim 47 is drawn to the IVL catheter assembly according to claim 45, wherein a wall of the polymer tube comprises two or more lumens distal to the port. The location of “the port” is unclear and confusing in light of the phrase “in a middle portion thereof” in claim 45, as set forth above. The location of the port is relevant to the determination of the location of the “two or more lumens distal to the port”. The specification at ¶314 discloses that “a wall of the polymer tube comprises two or more lumens distal to the port.” The specification at ¶318 discloses “wherein the polymer tube forms a port, which is to receive a guidewire, in a middle portion thereof, and wherein, distal to the port and proximal to the balloon, the polymer tube forms two or more lumens. The specification indicates that the port is proximal to the balloon, such that the two or more lumens are distal to the port, but proximal to the balloon. However, the claim may also be interpreted as the two or more lumens being distal to the port that receives the guidewire.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909).
Claim 52 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 52 recites the limitation "the first lumen" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 52 is dependent on claim 51, which does not recite “a first lumen”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 51-56 and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al., US 20220338890 (27 October 2022).
Regarding new independent claim 51, Anderson teaches an intravascular lithotripsy (IVL) catheter assembly (FIGs 1, 3, system 100), comprising:
a proximal lumen having a proximal portion and a distal portion (FIGs 1, 3);
a polymer tube (FIG 3, inner elongated structure 318 comprising polymer layer 420, FIG 4B; ¶274) connected to the distal portion of the lumen (FIG 3), the polymer tube (318) defining a distal portion (FIGs 4A, 4B, ¶274); and
a balloon (FIG 1, 110) bonded to the distal portion of the polymer tube (FIGs 1, 3, ¶¶28, 260, 339),
wherein the lumen (FIGs 1, 3), the polymer tube (318), and the balloon (110) are configured in size and shape to allow at least a portion of the IVL catheter assembly (100) to be inserted into a coronary vessel (¶258),
wherein the polymer tube (318) further defines a middle portion (FIGs 1, 3) defining a port (FIG 3, inflation port 310, power port 312, access port 308; ¶265) configured to receive a guidewire (FIG 4B, guidewire lumen 322; ¶274), and
wherein, distal to the port and proximal to the balloon (110), the polymer tube (318) defines two or more other lumens (FIGs 3, 4A, inflation lumen 320, guidewire lumen 322, wire lumen 406A, wire lumen 406B).
Regarding new claim 52, Anderson teaches the IVL catheter assembly according to claim 51, as set forth above.
Anderson teaches wherein the first lumen (guidewire lumen 322; ¶267) defines a distal tip (FIGs 1, 3) and an outer wall of the polymer tube (FIG 4B, 318) thickens with position moving from the distal tip of the proximal lumen to the port (FIGs 1, 3; ¶12; claim 10; FIG 10, element 1006; ¶299).
Regarding new claim 53, Anderson teaches the IVL catheter assembly according to claim 51, as set forth above, for the reasons set forth above.
Anderson teaches wherein an outer wall of the polymer tube (FIG 4B) enlarges in a dimension transverse to a longitudinal axis (FIGs 1, 3; ¶12; claim 10; FIG 10, element 1006; ¶299) and includes the two or more other lumens (FIG 3, inflation lumen 320, guidewire lumen 322,wire lumen 406A, wire lumen 406B).
Regarding new claim 54, Anderson teaches the IVL catheter assembly according to claim 51, as set forth above, for the reasons set forth above.
Anderson teaches wherein the two or more other lumens are selected from a first lumen for conveying a first wire conductor (FIG 4A, 406A), a second lumen for conveying a second wire conductor (FIG 4B, 406B), a third lumen for conveying saline solution (320, ¶265), and a fourth lumen for conveying a guidewire (FIG 3, 4B, 322).
Regarding new claim 55, Anderson teaches the IVL catheter assembly according to claim 51, as set forth above, for the reasons set forth above.
Anderson teaches wherein, proximal to the port, the polymer tube (318) defines an open interior region (FIG 4B, guidewire lumen 322; ¶¶266, 267).
Regarding new claim 56, Anderson teaches the IVL catheter assembly according to claim 51, as set forth above, for the reasons set forth above.
Anderson teaches wherein, a size of at least one (FIGs 3, 4A, 4B, guidewire lumen 322) of the two or more other lumens (FIG 3, inflation lumen 320, guidewire lumen 322, wire lumen 406A, wire lumen 406B) increases with position distally from the port toward the distal portion of the polymer tube (318, ¶35).
Regarding new independent claim 60, Anderson teaches an intravascular lithotripsy (IVL) catheter assembly (FIGs 1, 3, system 100) comprising:
a catheter shaft (catheter 104) extending from a proximal region to a distal region (FIGs 1, 3),
the distal region (FIG 3, distal portion 304) having a polymer tube (318) extending from a proximal end to a distal end (FIG 4B, polymer layer 420; ¶274);
and a balloon (FIG 1, balloon 110) bonded to the distal end of the polymer tube (318; ¶¶28, 260, 339); and
at least one electrode (FIG 4A, pair of conductive electrodes 402A, B) disposed within the balloon (FIGs 1, 3) and configured to discharge an electric arc (FIG 4A-B, spark gap 401 between electrode pair 402, ¶351 ),
wherein the catheter shaft (FIGs 1, 3, catheter 104) and the balloon (110) are configured in size and shape to allow at least a portion of the IVL catheter assembly (100) to be inserted into a coronary vessel (¶258), and
wherein the polymer tube (FIG 3, inner elongated structure 318 comprising polymer layer 420, FIG 4B; ¶274) comprises an outer wall (FIG 4A, outer elongated structure 316) defining at least two lumens, each lumen corresponding to a wire conductor (wire 406A and wire 406B).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 41-50, 57-59, 61-92 are rejected under 35 U.S.C. 103 as obvious over Anderson et al., US 20220338890 (27 October 2022) in view of ASTM F2606-08, Section 8.4 “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems (4 April 2014).
Regarding new independent claim 41, Anderson teaches an intravascular lithotripsy (IVL) catheter assembly (FIGs 1, 3, system 100), comprising:
an elongate conduit (elongated body 106; ¶274) extending from a proximal end to a distal end and being configured to convey a fluid therethrough (¶5), the elongate conduit defining a distal portion positioned adjacent the distal end (FIG 3, distal portion 304; distal port 324; ¶267);
a polymer tube (FIG 3, inner elongated structure 318 comprising polymer layer 420, FIG 4B; ¶274) connected to the distal portion of the elongate conduit (106), the polymer tube (318) defining a corresponding distal portion (¶274); and
a balloon (110) bonded to the distal portion of the polymer tube (FIGs 1, 3, 318, ¶260),
wherein the elongate conduit (106), the polymer tube (FIG 4B, 420), and the balloon (110) are configured in size and shape to allow a portion of the IVL catheter assembly (104) to be inserted into a coronary vessel (¶258).
Anderson does not teach wherein a bending stiffness of the IVL catheter assembly at a position distal of the proximal end of the elongate conduit is less than or equal to 20 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube 318 of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 42, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson does not expressly teach wherein the bending stiffness is less than or equal to 16.7 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 43, Anderson modified by ASTM F2606-08 teaches IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is measured at a position within a range from the balloon to 12 inches from a distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube or the location from which the bending stiffness may be measured. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube anywhere along the length of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 44, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is an average of forces, which displace the polymer tube by 5 mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Table 1 at p.3 of the Standard indicates that the recommended span length and maximum deflection for the variable span length method would be a stent length greater than 35mm with a maximum deflection of 0.2 x (span length) where span length is (stent length divided by 1.093) minus 2.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 45, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson teaches wherein the polymer tube (FIG 3, inner elongated structure 318 comprising polymer layer 420, FIG 4B; ¶274) forms a port (FIG 3, distal port 324), which is to receive a guidewire, in a middle portion thereof (FIG 4B, guidewire lumen 322, ¶274).
Regarding new claim 46, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 45, as set forth above, for the reasons set forth above.
Anderson does not teach wherein a bending stiffness measured at the port is higher than a bending stiffness measured at 12 inches from a distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Table 1 at p.3 of the Standard indicates that the recommended span length and maximum deflection for the variable span length method would be a stent length greater than 35mm with a maximum deflection of 0.2 x (span length) where span length is (stent length divided by 1.093) minus 2.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 47, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 45, as set forth above, for the reasons set forth above.
Anderson teaches wherein a wall of the polymer tube (FIG 3, inner elongated structure 318 comprising polymer layer 420, FIG 4B; ¶274) comprises two or more lumens (FIGs 3, 4A, inflation lumen 320, guidewire lumen 322, wire lumen 406A, wire lumen 406B; ¶266-267).
Anderson also teaches inflation lumen 320 and guidewire lumen 322 distal to inflation port 310, access port 308, and power port 312 (FIGs 1, 3), where claim 47 is broadly interpreted in its dependency on claim 45 such that the port is located in the middle portion of the polymer tube (FIGs 1, 3). For purposes of compact prosecution, the port of claim 45 is broadly interpreted in light of the specification which discloses two recitations of “distal to the port”. The specification at ¶314 discloses that “a wall of the polymer tube comprises two or more lumens distal to the port.” The specification at ¶318 discloses “wherein the polymer tube forms a port, which is to receive a guidewire, in a middle portion thereof, and wherein, distal to the port and proximal to the balloon, the polymer tube forms two or more lumens. The specification indicates that the port is proximal to the balloon, such that the two or more lumens are distal to “the port”, but proximal to the balloon.
Regarding new claim 48, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 47, as set forth above, for the reasons set forth above.
Anderson teaches wherein the two or more lumens includes lumens for two wire conductors, saline solution, and the guidewire (FIG 3, ¶267) to pass up to a region of the IVL catheter assembly (104) adjacent to the distal portion of the polymer tube (318) to which the balloon (110) is bonded (FIGs 1, 3, ¶¶28, 260, 339).
Regarding new claim 49, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson teaches wherein an outer wall of the polymer tube (318) thickens from the distal end of the elongate conduit (FIG 10, 1006; ¶299).
Regarding new claim 50, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson teaches wherein the polymer tube (318) distal of the elongate conduit has no support structure other than a material of the polymer tube (¶¶300, 301).
Regarding new claim 57, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 46, as set forth above, for the reasons set forth above.
Anderson teaches wherein the at least one lumen is configured to convey a saline solution therethrough (FIG 3, inflation lumen 320 (“the clinician may use inflation port 310 to inject an inflation fluid, such as a saline/contrast-fluid solution”, ¶265).
Regarding new claim 58, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson teaches wherein, external of the two or more other lumens, the polymer tube (318; ¶267) has no support structure other than a material and configuration thereof (¶¶299-301).
Regarding new claim 59, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 41, as set forth above, for the reasons set forth above.
Anderson teaches the assembly further comprising: an outer polymer tube (316) overlapping the distal portion of the proximal lumen and a portion of the IVL catheter assembly (100) distal to the proximal lumen (FIG 3).
Regarding new independent claim 61, Anderson teaches an intravascular lithotripsy (IVL) catheter assembly (FIGs 1, 3, system 100), comprising:
a catheter shaft (FIGs 1, 3, catheter 104) extending from a proximal region to a distal region, the distal region having a polymer tube defining a distal portion (FIG 3, inner elongated structure 318 comprising polymer layer 420, FIG 4B; ¶274); and
a balloon (110) bonded to the distal portion of the polymer tube (FIGs 1, 3, ¶¶28, 260, 339),
wherein the catheter shaft (104) and the balloon (110) are configured in size and shape to allow at least a portion of the IVL catheter assembly (100) to be inserted into a coronary vessel (¶258),
Anderson does not teach wherein a bending stiffness of the polymer tube is less than or equal to 20 g/mm without a mandrel disposed between a distal end of the elongate conduit and a proximal end of the balloon.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 62, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson wherein the IVL catheter assembly 100 defines a distal tip (FIGs 1, 3).
Anderson does not teach wherein the bending stiffness is less than or equal to 9.6 g/mm at a position of 3 inches from the distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 63, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) defines a distal tip (FIGs 1, 3).
Anderson does not teach wherein the bending stiffness is less than or equal to 8.5 g/mm at a position of 6 inches from the distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 64, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) defines a distal tip (FIGs 1, 3).
Anderson does not teach wherein the bending stiffness is less than or equal to 10.5 g/mm at a position of 12 inches from the distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 65, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) comprises a rapid exchange port (¶344).
Anderson does not teach wherein the bending stiffness is less than or equal to 15.1 g/mm at the rapid exchange port of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 66, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is less than or equal to 8.10 g/mm to 9.68 g/mm at a position of the balloon.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 67, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) defines a distal tip (FIGs 1, 3).
Anderson does not teach wherein the bending stiffness is less than or equal to 9.50 g/mm to 9.85 g/mm at a position of 3 inches from the distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 68, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) defines a distal tip (FIGs 1, 3).
Anderson does not teach wherein the bending stiffness is less than or equal to 7.46 g/mm to 9.20 g/mm at a position of 6 inches from the distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 69, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) defines a distal tip (FIGs 1, 3).
Anderson does not teach wherein the bending stiffness is less than or equal to 10.32 g/mm to 10.72 g/mm at a position of 12 inches from the distal tip of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 70, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 61, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) comprises a rapid exchange port (¶344).
Anderson does not teach that the bending stiffness is less than or equal to 14.43 g/mm to 16.39 g/mm at the rapid exchange port of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new independent claim 71, Anderson teaches an intravascular lithotripsy (IVL) catheter assembly (FIGs 1, 3, system 100), comprising:
a hypotube (FIGs 4A,B, hypotube 410);
a catheter shaft (FIGs 1, 3, catheter 104) having a polymer conduit in a distal portion thereof (FIG 3, inner elongated structure 318 comprising polymer layer 420, FIG 4B; ¶274); and
a balloon (100) bonded to a distal portion of the catheter shaft (FIGs 1, 3, ¶¶28, 260, 339),
wherein the catheter shaft (FIGs 1, 3, catheter 104) and the balloon (110) are configured in size and shape to allow at least a portion of the IVL catheter assembly (100) to be inserted into a coronary vessel (¶258).
Anderson does not teach wherein a bending stiffness of IVL catheter assembly is less than or equal to about 15 g/mm at a selected longitudinal position, where a major portion of the bending stiffness is provided by a first polymer wall of the polymer conduit.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem ((intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 72, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the selected position is 3 inches from a distal tip of the IVL catheter assembly and the bending stiffness at the selected position is less than or equal to 9.6 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 73, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the selected position is 6 inches from a distal tip of the IVL catheter assembly and the bending stiffness at is less than or equal to 8.5 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 74, Anderson modified by ASTM F2606-08 teaches IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the selected position is 12 inches from a distal tip of the IVL catheter assembly and the bending stiffness at is less than or equal to 10.5 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 75, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) comprises a rapid exchange port (¶344).
Anderson does not teach wherein the selected position is at a rapid exchange port of the IVL catheter assembly and the bending stiffness at is less than or equal to 15.1 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 76, Anderson modified by ASTM F2606-08 teaches IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the selected position is 3 inches from a distal tip of the IVL catheter assembly and the bending stiffness at is less than or equal to 9.50 g/mm to 9.85 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 77, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the selected position is 6 inches from a distal tip of the IVL catheter assembly and the bending stiffness at is less than or equal to 7.46 g/mm to 9.20 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 78, Anderson modified by ASTM F2606-08 teaches IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the selected position is 12 inches from a distal tip of the IVL catheter assembly and the bending stiffness at is less than or equal to 10.32 g/mm to 10.72 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 79, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson teaches wherein the IVL catheter assembly (100) comprises a rapid exchange port (¶344).
Anderson does not teach the bending stiffness is less than or equal to 14.43 g/mm to 16.39 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 80, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 71, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the selected position is disposed in an extent of the balloon of the IVL catheter assembly and the bending stiffness at is less than or equal to 8.10 g/mm to 9.68 g/mm. It is noted that the phrase “in an extent” is not expressly provided in the originally filed claims, ipsa verba. However, the examiner broadly interprets the phrase as the size, range, area, or scope of something and accordingly broadly interprets “an extent” to encompass any portion of the balloon (110) of the IVL catheter assembly (100) taught bv Anderson.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new independent claim 81, Anderson teaches an intravascular lithotripsy (IVL) catheter assembly extending from a proximal end to a distal end, the IVL catheter assembly comprising:
a balloon (110) disposed toward the distal end (FIG 3) of the IVL catheter assembly (100);
at least one electrode (FIG 4A, pair of conductive electrodes 402A, B) disposed within the balloon (110) and configured to create a shock/pulse (¶275);
a polymer tube (318) extending proximally (FIGs 1, 3) from the balloon (110),
the polymer tube (318) defining a lumen (FIG 3, inflation lumen 320) being configured to convey a fluid therethrough (¶265), the IVL catheter assembly (100).
Anderson does not teach wherein a bending stiffness of the polymer tube is less than or equal to 20 g/mm.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 82, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson teaches the catheter assembly further comprising a catheter shaft (104) proximal of the polymer tube (318).
Regarding new claim 83, Anderson modified by ASTM F2606-08 teaches IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson teaches wherein the polymer tube (318) further defines an outer wall enclosing the lumen (316), the IVL catheter assembly (100) further comprising a conductor for powering the electrode (FIG 2, ¶262), wherein the conductor is embedded in the outer wall of the polymer tube (FIG 3, power port 312; ¶265).
Regarding new claim 84, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is less than or equal to 9.6 g/mm at a position about 3 inches proximal of the distal end of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 85, Anderson modified by ASTM F2606-08 teaches the 85. (New) The IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is less than or equal to 8.5 g/mm at a position about 6 inches proximal of the distal end of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 86, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is less than or equal to 10.5 g/mm at a position about 12 inches proximal of the distal end of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 87, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson teaches the IVL catheter assembly (100) further comprising a rapid exchange port (¶344).
Anderson does not teach wherein the bending stiffness is less than or equal to 15.1 g/mm at a position adjacent the rapid exchange port.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 88, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is less than or equal to 9.50 g/mm to 9.85 g/mm at a position about 3 inches proximal of the distal end of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 89, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is less than or equal to 7.46 g/mm to 9.20 g/mm about 6 inches proximal of the distal end of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 90, Anderson modified by ASTM F2606-08 teaches IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson does not teach wherein the bending stiffness is less than or equal to 10.32 g/mm to 10.72 g/mm about 12 inches proximal of the distal end of the IVL catheter assembly.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 91, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson teaches the IVL catheter assembly (100) further comprising a rapid exchange port (¶344).
Anderson does not teach wherein the bending stiffness is less than or equal to 14.43 g/mm to 16.39 g/mm at a position adjacent the rapid exchange port.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Regarding new claim 92, Anderson modified by ASTM F2606-08 teaches the IVL catheter assembly according to claim 81, as set forth above, for the reasons set forth above.
Anderson teaches the IVL catheter assembly (100) further comprising a rapid exchange port (¶344).
Anderson does not teach wherein the bending stiffness is less than or equal to 8.10 g/mm to 9.68 g/mm at a position adjacent the balloon.
Bending stiffness is a testable, measurable, and quantifiable physical characteristic of a system component, as taught by ASTM F2606-08. ASTM F2606-08 is the “Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems”. ASTM F2606-08 defines “bending stiffness” at 2.1.2 as “a measure of the ability of a test specimen to resist bending”. Accordingly, ASTM F2606-08 discloses that bending stiffness is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures (ASTM F2606-08). Bending stiffness of the polymer tube of Anderson may be tested according to ASTM F2606-08 standards without undue experimentation. Additionally it is noted that, as a conversion metric, a bending stiffness of less than or equal to 20 g/mm equates to 0.196133 N/mm or less.
Although, Anderson discloses the claimed base device (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon) that is used for the same purpose, Anderson does not disclose the bending stiffness of the polymer tube. ASTM F2606-08 specifically addresses bending stiffness of balloon expandable vascular stent systems as “a measure of the ability of a test specimen to resist bending” (section 2.1.2). Accordingly, ASTM F2606-08 discloses that bending stiffness of a component is a physical characteristic of a component that is amenable to testing. The standard guide provides testing guidelines for quantitatively characterizing stent system flexibility using three-point bending procedures. Bending stiffness of the polymer tube of Anderson is amenable to the testing methodology disclosed in ASTM F2606-08 standards.
MPEP 2112(V) states that “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose, Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose.
Additionally, MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”
There is nothing disclosed in the claims or the specification to indicate that the claimed device exhibits any critically different or unexpected properties compared to the device of Anderson. Because Anderson’s base device is substantially identical to the claimed device and is used for the same purpose, a person of ordinary skill in the art, seeking to improve upon Anderson’s base device, would reasonably look to ASTM F2606-08 as the applicable standard for comparing physical characteristics of components of balloon expandable vascular stents systems.
Because the Patent Office does not have the facilities to determine whether the IVL catheter assembly of the claims has the requisite bending stiffness, the burden is on the application to show a novel and unobvious difference between the catheter assembly components as claimed and those of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
It would also have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Anderson and ASTM F2606-08, given that the prior art contained a base device and known techniques to measure and test physical properties of the base device. One of ordinary skill in the art would have been capable of applying a known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Anderson and ASTM F2606-08 teach in the same field of endeavor, that of balloon expandable vascular stents systems.
Because Applicant is in the same field as Anderson and is claiming a substantially identical device used for the same purpose (Anderson: coronary-treatment ¶3), Applicant is in the best position to provide evidence of the bending stiffness of the device of Anderson. Absent evidence to the contrary, the IVL catheter assembly of Anderson is substantially identical to the claimed device and it is used for the same purpose. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Additionally, with regard to the bending stiffness, as the bending stiffness value changes, the bendability of the tube changes. Accordingly, bending stiffness is a results-effective variables which can be optimized. One of skill in the art would clearly recognize that the bendability of a catheter is optimizable through routine experimentation in order to arrive at a bending stiffness that falls within the claimed range based on the desired stiffness needed for the treatment applied. Anderson teaches the need for systems and applications of IVL systems in coronary-treatment applications (¶3). There have been a finite number of identified and predicable solutions to coronary-treatment applications using IVL, such as the ones taught by Anderson and ASTM F2606-08, Section 8.4, showing that bendability stiffness is important for . Given Anderson’s teachings ASTM F2606-08, Section 8.4 (bending flexibility of two or more test articles), one of ordinary skill in the art would understand that there was a recognized problem or need in the art to solve a problem of bending stiffness value changes.
A person of ordinary skill in the art would recognize that the bendability of a tube and thus, its bending stiffness, changes based on its composition. Anderson clearly recognizes that catheter structures must be optimized for anatomical features given that “elongated body 106 is configured to navigate a tortuous vasculature of a patient toward a target treatment site” (¶259). ASTM F2606-08 also recognizes the design needs and market pressure to solve problems encompassing physical properties such as bending stiffness. ASTM F2606-08 provides a finite predictable potential solution by providing a standardized methodology to compare the bending stiffness of two or more test articles (Section 8.4), providing one of ordinary skill in the art with a reasonable and quantifiable basis to pursue routine comparative studies through routine experimentation in order to optimize the bending stiffness with a reasonable expectation of success.
Additionally, it is well-settled that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988). Both Anderson (¶258) and the instant claims focus the use of the device in coronary vessels. A person of ordinary skill in the art would experiment with different bending stiffness values to arrive at the one that is optimized for coronary vessels, which could fall within the same range as that of the prior art. As such, the determination of bending stiffness would amount to nothing more than routine experimentation that can be optimized on an anatomically-specific use-case basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (intravascular lithotripsy catheter assembly comprising a elongate conduit, polymer tube, and a balloon, where the polymer tube comprises a bending stiffness) and the proposed testing is standard is mechanically compatible and implemented by routine engineering practices (following the three-point bending test guidance in the standard), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in applying a known measurement technique with a resulting improvement.
Conclusion
No claim is allowed. This Office Action is NON-FINAL.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chisena et al., US 20200046949 (13 February 2020) teaches a system for effecting and controlling oscillatory pressure within balloon catheters for fatigue fracture of calculi.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHERIE M POLAND/Examiner, Art Unit 3771
Prosecution Insights