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 .
Election/Restrictions
Claims 26-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method claims, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
Applicant’s election without traverse of claims 1-5 and 20-25 in the reply filed on 10/30/2025 is acknowledged.
Claim Objections
Claims 1, 3-5, 10, 22-25 are objected to because of the following informalities:
Claims 1 and 3-5 recite “said loop” or “the loop” throughout the claims and should be amended to recite said/the “loop of flexible material” for consistency purposes.
Claims 20, 23, and 25 recite “the balloon” throughout the claims and should be amended to recite “the inflatable balloon” for consistency purposes.
Claims 20, 22, and 24 recite “said loop” or “the loop” throughout the claims and should be amended to recite said/the “loop of flexible material” for consistency purposes.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a displaceable element” in claims 1 and 20. The limitation describing the positioning member in claims 1 and 20 (“extending along said elongated shaft and associated with at least one side of said loop so that displacement of a part of said displaceable element from a proximal end of the guiding catheter controls displacement of said loop between said proximal position and said distal position, such that, when the balloon catheter is inserted along the guidewire in a deflated state so as to extend across the lesion, pushing the displaceable element is effective to advance said loop from the proximal position over the external surface of the balloon catheter to the distal position so that subsequent inflation of the balloon catheter is effective to press the loop against the lesion” in claim 1 and “a displaceable element extending along the catheter so that displacement of a part of said displaceable element outside the body controls displacement of said loop relative to said balloon” in claim 20) fails to include sufficient structure to perform the recited function of "displacement". The drawings illustrate the displacement element 120 as an elongated member (see Figs. 7A-B, page 11, lines 4-5).Therefore, the displacement element is interpreted as an elongated element or any structural equivalent thereof that is connected to the loop of flexible material and controls displacement of the flexible loop of material between the proximal position and the distal position.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 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 1 recites the limitation "said lumen" in line 11. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear to the examiner if “said lumen” is meant to further define the “at least one hollow lumen” introduced in line 8 or defining a new, additional, lumen. For examination purposes, “said lumen” is interpreted as “said at least one hollow lumen”.
Claim 3 recites the limitation "the balloon" in line 3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear to the examiner if “the balloon” is meant to further define the “balloon catheter” introduced in the preamble or defining “a balloon”. For examination purposes, “the balloon” is interpreted as “a balloon”.
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.
Claim(s) 1, 3, 4, 20-21, 23, and 25 are rejected under 35 U.S.C. 102(1) as being anticipated by Silvestro (US 20140324079).
The embodiment of Figs. 3-3C is relied upon for the rejection. However, other embodiments are relied upon as well for like features or shared features not shown in Figs. 3-3C. The examiner further notes that para. 0051 discloses authorizes the combination of embodiments.
Regarding claim 1, Silvestro discloses an angioplasty enhancement device 10a (Figs. 3-3C, para. 0040) for use with an angioplasty system including a guiding catheter, a guidewire inserted through the guiding catheter and extending beyond the guiding catheter to cross a lesion, and a balloon catheter 10a insertable along the guidewire through the guiding catheter to reach the lesion (para. 0040, 0044, 0047-0048, 0051; see note below in regards to functional language and intended use), the angioplasty enhancement device comprising:
(a) an elongated shaft 30 sized for insertion through the guiding catheter and to extend beyond the guiding catheter (Figs. 3A-C, para. 0040, 0047), at least a distal portion of said elongated shaft being formed as a guide extension catheter (interpreted as distal portion of sheath 30) with at least one hollow lumen to accommodate the guidewire and the balloon catheter 26, 106 (Figs. 1, 1B, para. 0036 discloses that the balloon catheter shaft 12 may comprise a lumen, Figs. 3A-C, para. 0040 discloses that the elongated shaft 30 has a lumen to accommodate the balloon catheter, and para. 0044 discloses that the lumen of the balloon catheter may be used for receiving a guidewire).;
(b) a loop of flexible material (interpreted as one loop of the series of loops forming distal portion of the scoring member 22a, Fig. 3, para. 0040) displaceable between a proximal position located within said lumen of said guide extension catheter (Fig. 3A, para. 0040) and a distal position extending beyond said guide extension catheter for overlying an external surface of the balloon catheter (Fig. 3C, para. 0040); and
(c) a displaceable element (interpreted as the linear proximal portion of the cutting scoring element 22a see Fig. 3, para. 0040; The examiner notes that the embodiment of Figs. 4A-E and 5A-D define this portion as a control wire 41, para. 0041) extending along said elongated shaft 30 (Fig. 3, para. 0040) and associated with at least one side of said loop so that displacement of a part of said displaceable element from a proximal end of the guiding catheter controls displacement of said loop between said proximal position and said distal position (Figs. 3-3C; Para. 0040 discloses “Alternatively, the scoring member retrieval may also be supported by pulling the scoring member from its operative position, back inside the outer sheath 30. Additional components and/or design attributes may be added to the device 10a to facilitate the desired movement and deposition of the cutting or scoring member 22a on the balloon” and para. 0047 discloses that the scoring member may be retracted into the guide catheter once the guide catheter is positioned near the balloon such that the user would have to facilitate retraction from the proximal end of the guide catheter.), such that, when the balloon catheter is inserted along the guidewire in a deflated state so as to extend across the lesion, pushing the displaceable element is effective to advance said loop from the proximal position over the external surface of the balloon catheter to the distal position so that subsequent inflation of the balloon catheter is effective to press the loop against the lesion (Figs. 3A-3C, para. 0040; The examiner notes that the displaceable element of the embodiment of Figs. 3A-3C is pushed by pushing the outer sheath 30).
Note: “An angioplasty enhancement device for use with an angioplasty system including a guiding catheter, a guidewire inserted through the guiding catheter and extending beyond the guiding catheter to cross a lesion, and a balloon catheter insertable along the guidewire through the guiding catheter to reach the lesion” has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Robie, 88 USPQ 478 (CCPA 1951). The claims are directed towards an apparatus, not a method. Therefore, the language in the preamble is not interpreted as describing the claimed structural components of the claimed invention, but interpreted as describing the functionality and the intended use of the claimed invention. Therefore, “a guiding catheter”, “a guidewire”, and “a balloon catheter” is not positively claimed and are interpreted as functional components that the angioplasty device is capable of being used with. The device of Silvestro comprises all of the structure required for the functional language in the preamble (“elongated shaft”, “guide extension catheter”, “loop of flexible material” and “displaceable element”) and is used for the same intended purpose of treating a stenotic region in vasculature with the guiding catheter, guidewire, and balloon catheter (see para. 0040, 0044, 0047-0048, 0051), and therefore meets the functional language described. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 3, Silvestro discloses wherein the loop (interpreted as one loop of the series of loops forming distal portion of the scoring member 22a, Fig. 3, para. 0040) is a wire loop formed with a U-shaped distal tip (Figs. 3B-3C, para. 0037) such that, when said wire loop is pressed by the balloon 18a against the lesion (para. 0040), pulling of the wire loop is effective to scrape debris from the lesion and to gather the debris within the loop towards a proximal end of the balloon (see note below).
Note: “pulling of the wire loop is effective to scrape debris from the lesion and to gather the debris within the loop towards a proximal end of the balloon” is interpreted as intended use of the device (see note above in claim 1 in regards to intended use). The device of Silvestro comprises all of the structure required for the functional limitation of claim 3 (wire loop that is capable of being manually actuated, see second to last sentence of para. 0040). For example, the user may partially deflate the balloon such that the wire loop may be maneuvered independently to scrape plaque or partially deflate the balloon such that it still supports the wire loop and the user can pull the wire loop and the balloon to scrape debris form the lesion, in light of the intended use of the device.
Regarding claim 4, Silvestro discloses wherein the loop (interpreted as one loop of the series of loops forming distal portion of the scoring member 22a, Fig. 3, para. 0040) is one of at least two loops spaced apart so as to advance around at least two respective regions of a periphery of the balloon catheter (Fig. 3, para. 0040), said respective regions being on opposite sides of a central longitudinal axis of the balloon catheter (Fig. 3, para. 0040; The examiner notes that the loops 22a encircle the entire balloon such that they deploy across at least two respect regions of the periphery of the balloon).
Regarding claim 20, Silvestro discloses a device 10a for percutaneous deployment to remove material from an internal surface of a blood vessel within a body of a human (Figs. 3-3C, para. 0040), the device comprising:
(a) a deployment catheter 30 for percutaneous deployment within the blood vessel (Figs. 3A-3C, para. 0040);
(b) an inflatable balloon 18a configured for deployment from the catheter (Figs. 3A-3C, para. 0040);
(c) and a displaceable loop of flexible material (interpreted as one loop of the series of loops forming distal portion of the scoring member 22a, Fig. 3, para. 0040) displaceable across an external surface of the balloon 18a for deployment with the balloon (Figs. 3A-3C, para. 0040), at least one side of the loop being connected via a displaceable element (interpreted as the linear proximal portion of the cutting scoring element 22a see Fig. 3, para. 0040; The examiner notes that the embodiment of Figs. 4A-E define this portion as a control wire 41, para. 0041) extending along the catheter so that displacement of a part of said displaceable element outside the body controls displacement of said loop relative to said balloon (Figs. 3-3C, para. 0040);
wherein the balloon and the loop of flexible material are configured such that, when the balloon is inflated, the loop of flexible material is pressed against the internal surface of the blood vessel (para. 0040) so that pulling the at least one side of the loop is effective to scrape material from the internal surface of the blood vessel and to gather the material within the loop towards a proximal end of the balloon, and such that, when the balloon is at least partially deflated, pushing the at least one side of the loop is effective to return the loop to a distal position (Figs. 3A-3C, para. 0040; see note below in regards to functional language).
Note: “configured such that, when the balloon is inflated, the loop of flexible material is pressed against the internal surface of the blood vessel so that pulling the at least one side of the loop is effective to scrape material from the internal surface of the blood vessel and to gather the material within the loop towards a proximal end of the balloon, and such that, when the balloon is at least partially deflated, pushing the at least one side of the loop is effective to return the loop to a distal position” is interpreted as functional language. The examiner further notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. The device of Silvestro comprises all of the structure required for the functional limitation of claim 20 (the loop of flexible material that is capable of being manually actuated, see second to last sentence of para. 0040 and the inflatable balloon). For example, the user may inflate the balloon to press the loop against the plaque (as stated in para. 0040) and maneuver the loop independently to scrape material from the internal surface of the blood vessel and to gather the material within the loop towards the proximal end of the balloon, and such that, when the balloon is at least partially deflated, pushing the at least one side of the loop is effective to return the loop to the distal position, in light of the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 21, Silvestro discloses wherein the loop of flexible material is a wire loop (Fig. 3, para. 0037).
Regarding claim 23, Silvestro discloses wherein the loop (interpreted as one loop of the series of loops forming distal portion of the scoring member 22a, Fig. 3, para. 0040) is one of at least two displaceable loops for deployment across at least two respective regions of a periphery of the balloon (Fig. 3, para. 0040), said respective regions being on opposite sides of a central longitudinal axis of the balloon (Fig. 3, para. 0040; The examiner notes that the loops 22a encircle the entire balloon such that they deploy across at least two respect regions of the periphery of the balloon).
Regarding claim 25, Silvestro discloses wherein at least a distal portion of the deployment catheter 30 is implemented as a guide extension catheter having a lumen (Fig. 3, para. 0040), and wherein the balloon 18a is part of a balloon catheter 12a inserted along the lumen of the guide extension catheter (Fig. 3, para. 0040).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Silvestro (US 20140324079).
Regarding claim 2, Silvestro discloses all of the limitations set forth above in claim 1. However, the embodiment of Figs. 3-3C of Silvestro fail to disclose wherein a majority of a length of said elongated shaft proximal to said guide extension catheter is implemented as a tube sized for accommodating only said displaceable element while lying in side-by-side relation to the guidewire and the balloon catheter within the guiding catheter.
The embodiment of Figs. 1-1B of Silvestro teaches that it is known in the art to construct a tubular element 12 with a first lumen 26 and a second lumen 24 (Fig. 1B, para. 0036), wherein a majority of a length of the tube element 12 is implemented as a tube 16 sized for accommodating only a displaceable element (interpreted as linear portion of scoring member 22) within the second lumen 24 while lying in side-by-side relation to a guidewire within the first lumen 26 within a guiding catheter (para. 0036-0037, 0044, 0047, 0051).
In light of this teaching, it would have been recognized by one of ordinary skill in the art that applying the known technique (dual lumen construction) taught by the embodiment of Figs. 1-1B to the elongated shaft of the embodiment of Figs. 3-3C (single lumen construction) would have yielded predicable results, namely an alternative way to accommodate the displaceable element in relation to the balloon catheter and guidewire (para. 0036-0037 of Silvestro).
Claim(s) 5 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Silvestro (US 20140324079) as applied to claims 1 and 20 above, and further in view of Kilemnik (US 20110276081).
Regarding claims 5 and 24, Silvestro discloses all of the limitations set forth above in claims 1 and 20. However, Silvestro fails to disclose further comprising a handle associated with a proximal end of said elongated shaft, and wherein displacement of said loop is controlled by an actuator associated with the handle.
Kilemnik teaches that it is known in the art for an elongated shaft 202, 204 to comprise a handle 206 associated with a proximal end of said elongated shaft 202, 204, and wherein displacement of a loop 212 is controlled by an actuator 210 associated with the handle 206 (Figs. 4A-C, para. 0050-0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the elongated shaft and the displaceable element in Silvestro to include the handle and the actuator of Kilemnik in order to provide a place for the user to grasp the sheath via. the handle and independently maneuverability of the displaceable element and thereby the loop via. the actuator which would improve the ease of use (para. 0050-0053 of Kilemnik).
Claim(s) 22 are rejected under 35 U.S.C. 103 as being unpatentable over Silvestro (US 20140324079) as applied to claim 20 above, and further in view of Casiraro et al. (US 20240081856) [hereinafter Casiraro] and Krolick et al. (US 20100036312) [hereinafter Krolick].
Regarding claim 22, Silvestro discloses all of the limitations set forth above in claim 20. However, Silvestro fails to disclose wherein two ends of the loop are associated with the displaceable element so to form a closed loop.
Casiraro in the same field of endeavor of angioplasty devices teaches a displaceable loop 14d of flexible material (Fig. 1, para. 0026, 0029) displaceable across an external surface of a balloon 24 for deployment with the balloon 24 (Figs. 2A-2C, para. 0030-0032), at least one side of the loop 14d being connected via a displaceable element 12.
Krolick in the same field of endeavor of looped scoring devices teaches that it is known the art to construct a closed loop 50 connected to a displaceable element 42 by having two ends 52, 54 of the loop 50 associated with the displaceable element 42 so to form the closed loop (Figs. 1-2, para. 0041).
In light of these teachings, the substitution of one known displaceable loop element for another (ring looped element as taught in Casiraro and Krolick) for another (spiral looped element as shown in Silvestro) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the ring looped element shown in Casiraro and Krolicj would have yielded predictable results, namely, provide the device with an alternative scraping element for breaking apart plaque in vasculature (para. 0032 of Casiraro).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771