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 .
Formal Matters
Applicant’s Response and Amendments filed 17 June 2026 are acknowledged. Claims 1-22 are pending. Claim 1 is currently amended. Claims 13-22 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 December 2024. Claims 1-12 are under examination.
Response to Arguments
Applicant argues that the amendments to claim 1 have overcome the rejections of record. Applicant argues that Kallok is not provided or designed for the purpose of preventing “jumping” (Remarks, numbered p. 8 of 10). Applicant argues that there is no disclosure of any aspect of absorbing and storing potential energy by determining and thus selecting an amount of energy storage with specific functionality as claimed (Remarks, numbered p. 8 of 10).
Applicant’s argument has been fully considered, but it is not persuasive. The rejection of claims 1 and 6-12 was made as a combinatorial rejection under 35 USC 103 as being unpatentable over Kallok, et al., WO 2020033260 A1 (13 February 2020), Shturman et al., US 6217595 (17 April 2001), and Higgins et al., US 20150201956 (23 July 2015). Kallok need not teach what is taught by Higgins, which expressly teaches the potential energy of torque coils, as explained of record on pages 5 and 6 of the Office Action mailed 17 March 2026. Applicant does not address the teachings of Higgins.
Applicant argues that the coils of Shturman comprise inner and outer filars wound in opposite directions and that these would not react as claimed for the purpose of storing potential energy (Remarks, numbered p. 9 of 10). Applicant’s arguments have been fully considered, but they are not persuasive. As stated of record, Shturman was not cited for its teaching of filar structure, but rather for the express teaching of heat shrink polymer as the constraining moiety (Office Action mailed 3/17/2026, p. 2, ¶4). Applicant’s attention is also directed to Shturman at FIGs 12 and 13 and ¶56 where Shturman teaches mono-filar embodiments comprising a lumen. The current claims do not recite any specific structure of the filars only that they are “wire filars”, recited in the plural form. The specification discloses filars 54 as being distinct from coils 52. (“wire filars and/or coil(s)”, ¶41). FIG 3 of the Drawings shows a lumen between filars 54 comprising a polymer coating or jacket 56 and uncoated 52 segments (¶54). Paragraph 60 further clarifies this coating structure when it disclosing the steps of applying heat in order to shrink both ends of the polymer heat-shrinkable tube around the straightened and fully compressed coils 52 (¶¶60-63).
Regarding claims 2-5, Applicant also argues that although the Diamondback 360 brochure discloses the total length, there is no disclosure of providing a combination of constrained and unconstrained drive shaft portions with the claimed relative length ratios or percentages as presently claimed (Remarks, numbered p. 9 of 10).
Applicant’s arguments have been fully considered, but they are not persuasive. In response to applicant's arguments against the references individually, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Objections/Rejections Maintained, Modified, and New – Necessitated by Amendment
Claim Objections
Amended claim 1 is objected to because of the following informalities: line 13 bridging to line 14 recites “...drive shaft section is not constrained by so as to permit a change…” [Emphasis added]. The word “by” in the claim is a modifier of a subject. However, the subject “the heat shrinkable polymer coating” has been deleted. The claim, as it is currently written, is awkward due to the continued inclusion of the word “by”. Appropriate correction is required.
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 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 1 and 6-12 remain rejected under 35 U.S.C. 103 as being unpatentable over Kallok et al., WO 2020033260 A1 (13 February 2020) in view of Shturman et al., US 6217595 (17 April 2001) and further in view of Higgins et al., US 20150201956 (23 July 2015), for the reasons of record and the reasons set forth herein.
Regarding currently amended claim 1, Kallok teaches a rotational atherectomy device comprising:
a handle comprising a prime mover (FIG 1; Abstract); and
an elongate drive shaft (p. 3, lines 16-20) that is rotationally connected with the prime mover (p. 2, lines 1-3, lines 30-31),
the elongate drive shaft comprising wire filars (FIGs 10; p. 12, lines 4-25), and extending from the handle to an abrasion tool spaced distally from the handle (Abstract; FIGs 1, 10; p. 9, lines 11-12; p. 10, lines 9-14), the elongate drive shaft defining a lumen extending within the elongate drive shaft from the handle to the abrasion tool (p. 9, lines 17-18) and including:
a constrained drive shaft section wherein the wire filars of the constrained drive shaft section (FIG 10; p. 12, lines 4-25) are constrained in an at least partially longitudinally and radially compressed configuration by a polymer coating (p. 12, lines 16-18, including PTFE (polytetrafluoroethylene) to restrain the wire filars of the constrained drive shaft section from radially expanding (p. 5, lines 28-31 to p. 6, lines 1-9; p. 12, lines 8-9; and p. 24, lines 7-11) and from longitudinal lengthening and shortening (p. 12, lines 7-9),
an unconstrained proximal-most drive shaft section disposed proximal to the constrained drive shaft section (FIGs 10; p. 12, lines 4-25) and operatively connected with the prime mover (claim 1),
an unconstrained distal drive shaft section disposed distal to the constrained drive shaft section (p. 12, line 21) and includes an abrasion tool (138; p. 3, lines 7-8) spaced from the constrained drive shaft section (FIGs 1, 10; p. 14, lines 28-31 to p. 15, lines 1-4), wherein the unconstrained distal drive shaft section is not covered or constrained by the polymer coating (p. 12, line 21),
wherein a length of the unconstrained proximal-most drive shaft section determines an amount of potential energy storage as can be transferred to the constrained drive shaft section (p. 12, lines 7-9, “the coating adds column strength to the drive shaft 136 to facilitate a greater ability to push the drive shaft 136 through stenotic lesions. In addition, the coating can enhance the rotational stability of the drive shaft 136 during use”; p. 3, lines 6-7 “the elongate flexible drive shaft defines a longitudinal axis and comprising a torque-transmitting coil”).
Kallok does not expressly teach that the polymer coatings are heat shrinkable.
Kallok does not expressly teach wherein the unconstrained proximal-most drive shaft section that is not constrained by [sic] so as to permit a change of length or radial diameter of the proximal-most unconstrained drive shaft section for extending the length of or the radial diameter of the unconstrained drive shaft section and/or radially expanding the unconstrained drive shaft section for storing potential energy as a result of applied torque by the elongate drive shaft being at least partially occluded.
Kallok does not expressly teach a length of the unconstrained proximal-most drive shaft section is determined based on the amount of potential energy storage that is predetermined.
Shturman teaches FIGs 1 and 2 and “a distal portion of the proximal segment 22 of the drive shaft 20 is encased in a thin, flexible, low friction coating or sheath. A heat shrinkable polytetrafluoroethylene tubing has been found to work well as such a sheath 22, but this sheath or coating may be made from any suitable material” (col 10, lines 8-17). At column 10, lines 8-17, Shturman teaches a constrained portion covered by heat shrinkable material at the distal end of the proximal section of the drive shaft. Shturman teaches that the coating or sheath 23 is sufficiently long so that its proximal end remains disposed inside the catheter when the drive shaft is fully extended, but the remaining proximal-most portion of the drive shaft is broadly interpreted as being unconstrained (col 10, lines 8-17). Shturman teaches a length of the proximal-most unconstrained drive shaft section for extending the length of or the radial diameter of the unconstrained drive shaft section and/or radially expanding the unconstrained drive shaft section (col 10, lines 8-17; col 16, lines 40-47). Shturman also teaches an embodiment at FIGs 12 and 13 comprising drive shaft 220’ that includes only a single helical coil 250’ and a lumen (col 16, lines 31-61).
Higgins teaches spin-to-open atherectomy devices with electric motor control (FIG 2) where the wires are unconstrained such that the drive shaft spins open under loading conditions (¶33). Higgins teaches the potential energy of torque coils at FIGs 10 and 11. Higgins states that “when the drive shaft is compressed rotationally under the influence of the angular momentum of the free-spinning motor, at some point, all the rotational kinetic energy from the angular momentum is converted to rotational potential energy, and the drive shaft reaches its most tightly wound point.” (¶108). Higgins teaches that “the drive shaft then unwinds, converting essentially all of its rotational potential energy into rotational kinetic energy and spinning the free-spinning motor in the opposite direction.” (¶109). FIG 12 of Higgins shows that the potential energy is determined by the length of an unconstrained/unobstructed portion of drive shaft (¶118).
The “prime mover” is broadly interpreted as an electric motor or turbine (Specification p. 7, ¶50).
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 Kallok, Shturman, and Higgins, given that the prior art included each element claimed, although not necessarily in a single reference. Kallok, Shturman, and Higgins teach in the same field of endeavor, that of motorized atherectomy devices.
Although, Kallok discloses the claimed base atherectomy device (handle, motor (prime mover), shaft, filars, constraining polymer coatings (PTFE), and abrasion elements), Kallok does not disclose that the constraining polymer coatings are heat shrinkable, that the unconstrained proximal-most drive shaft section is not covered or constrained by the heat shrinkable polymer coating so as to permit a change of length and/or radial diameter of the proximal-most drive shaft section for storing potential energy as a result of applied torque by the elongate drive shaft being at least partially occluded, or that the length of the unconstrained proximal-most drive shaft section is determined based on the amount of potential energy storage that is predetermined.
Shturman specifically addresses the heat shrinkable polytetrafluoroethylene tubing as an atherectomy device sheath. Because Kallok teaches a constraining polymer coating comprising PTFE (p. 12, lines 16-18) to restrain the wire filars of the constrained drive shaft section from longitudinal lengthening and shortening (p. 12, lines 7-9), a person of ordinary skill in the art would reasonably consult Shturman’s heat shrinkable solution. Moreover, Shturman also teaches an embodiment at FIGs 12 and 13 comprising drive shaft 220’ that includes only a single helical coil 250’ comprising a lumen (¶56), similar to the filar structure taught by Kallok at FIG 10. Additionally, Shturman teaches a length of the proximal-most unconstrained drive shaft section for extending the length of or the radial diameter of the unconstrained drive shaft section and/or radially expanding the unconstrained drive shaft section (col 10, lines 8-17; col 16, lines 40-47).
Higgins discloses spin-to-open coiled wire drive shafts where the wires are unconstrained such that the drive shaft spins open under loading conditions (¶33). Higgins expressly teaches the potential energy of torque coils at FIGs 10 and 11 and shows that the potential energy is determined by the length of an unconstrained/unobstructed portion of drive shaft (¶118). A person of ordinary skill in the art attempting to render Kallok’s filars compatible with a spin-to-open system to take advantage of the potential energy from the expanded drive shaft would look for established designs to avoid creating a novel drive shaft. Higgin’s open wires and lengthy discussion of constraints (blockages) that reduce the potential energy can be adapted to the filars and constrained segments taught by Kallok’s device to enable the use of controlled potential energy when the motor is not in use.
Additionally, the claimed length of the unconstrained proximal-most drive shaft section is determined based on the amount of potential energy storage that is predetermined is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that lengths can be optimized depending on the end effect desired for the use case. This is shown by FIG 12 and ¶118 of Higgins. One of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. The lengths of the unconstrained segments can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential energy needs for the intended use case and the anatomical structures for which the devices are designed to service. As such, adjusting the length of the unconstrained portion to achieve the spin-to-0pen potential energy of the filars would amount to nothing more than routine experimentation that can be optimized on an individual 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)).
Regarding claim 6, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok teaches the device further comprising an outer sheath extending distally away from the handle and comprising a lumen defined therethrough and a length, wherein the drive shaft extends through the lumen of the outer sheath (FIG 1; p. 9, lines 14-24), and wherein the length of the outer sheath is less than a length of the constrained drive shaft section (FIG 1; p. 10, lines 4-8). The recitation of “a length” is broadly interpreted as “any” length. The recitation of “a lumen” is broadly interpreted as any lumen or portion thereof.
Regarding claim 7, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok teaches the device further comprising an outer sheath extending distally away from the handle and comprising a lumen defined therethrough and a distal end, wherein the drive shaft extends through the lumen of the outer sheath (FIG 1; p. 9, lines 14-24), and wherein the distal end of the outer sheath is located distal to a distal end of the constrained drive shaft section (FIG 1; p. 10, lines 4-8).
Regarding claim 8, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok teaches the device further comprising an outer sheath extending distally away from the handle and comprising a lumen defined therethrough and a distal end, wherein the drive shaft extends through the lumen of the outer sheath (FIG 1; p. 9, lines 14-24;), and wherein the distal end of the outer sheath is spaced distally away from a distal end of the constrained drive shaft section (FIG 1; p. 10, lines 4-8).
This is also taught by Shturman at FIG 1, catheter 13, drive shaft 20; see also FIG 2 and col 9, line 63 to col 10, line 6, variable lengths of outer helical later 50 and inner helical layer 40; and col 10, lines 8-14.
Regarding claim 9, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 8, as set forth above, for the reasons set forth above.
Kallok teaches the device wherein the unconstrained proximal-most drive shaft section is located within the lumen of the outer sheath (FIG 1, sheath 132; p. 16-17, the flexible drive shaft 136 is slidably and rotatably disposed within a lumen of the sheath 132).
Regarding claim 10, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok teaches the device wherein the heat shrinkable polymer coating partially conforms with the wire filars of the drive shaft and defines an undulating longitudinal profile consisting of alternating peaks and valleys (FIGs 10-11; p. 2, line 20; p. 3, lines 16-17; p. 5, lines 28-31).
Regarding claim 11, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Shturman teaches the device wherein the wire filars of the constrained drive shaft section are constrained in a fully longitudinally compressed configuration by the heat shrinkable polymer coating (FIGs 1 and 2 and “a distal portion of the proximal segment 22 of the drive shaft 20 is encased in a thin, flexible, low friction coating or sheath 23. In a preferred embodiment, the coating or sheath 23 is sufficiently long so that its proximal end remains disposed inside the catheter (FIG 1, catheter 13) even when the drive shaft 20 is fully advanced distally with respect to the catheter. A heat shrinkable polytetrafluoroethylene tubing has been found to work well as such a sheath 22, but this sheath or coating may be made from any suitable material” (col 10, lines 8-17).
Regarding claim 12, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok teaches the device further comprising at least one tool disposed at or near a distal end of the drive shaft within the distal-most drive shaft section that is not constrained by the heat shrinkable polymer coating (FIGs 1 and 10-14; p. 9, lines 24-30)
This is also taught by Shturman at FIGs 1 and 2 (col 5, lines 32-34, rotational atherectomy device).
Claims 2-5 remain rejected in addition to claim 1, as set forth above, under 35 U.S.C. 103 as being unpatentable over Kallok et al., WO 2020033260 A1 (13 February 2020), in view of Shturman et al., US 6217595 (17 April 2001) and Higgins et al., US 20150201956 (23 July 2015) and further in view of DiamondBack360® brochure, CSI, 2019 (csi360.com/wp-content/uploads/ifu/EN-2334.C%20Diamondback%20Family%20Brochure.pdf) (last accessed 28 February 2025), for the reasons of record and the reasons set forth herein.
Kallok modified by Shturman and Higgins teach claim 1 as set forth above.
Claims 2 and 3 are similar in claim structure and are accordingly treated together for the purpose of this rejection. Similarly, claims 4 and 5 are similar in claim structure and are accordingly treated together for the purposes of this rejection.
Regarding claim 2, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok modified by Shturman and Higgins does not expressly teach wherein a total length of the drive shaft as measured from the handle is approximately 57 inches, and a length of the unconstrained proximal-most drive shaft section is within the range of 0.5 to 3 inches.
Regarding claim 3, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok modified by Shturman and Higgins does not expressly teach wherein a total length of the drive shaft as measured from the handle is approximately 57 inches, and a length of the unconstrained proximal-most drive shaft section is within the range of 1 to 2 inches.
The Diamondback360® brochure teaches standard atherectomy device shaft lengths as being approximately 57 inches (145 cm = approximately 57.1 inches) (Table, page 1 of 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 Kallok, Shturman, Higgins, and the Diamondback360® brochure given that the prior art included each element claimed, although not necessarily in a single reference. Kallok modified by Shturman and Higgins and the Diamondback360® brochure teach in the same field of endeavor, that of motorized atherectomy devices with drive shafts. There were design incentives or market forces which would have prompted adaptation of Kallok’s devices such that other known configurations of atherectomy devices would benefit, including shaft lengths of 145cm (approximately 57 inches) as taught by the Diamondback360® brochure. The differences between the claimed invention and the prior art were encompassed in known variations as taught by the 145cm, 180cm, and 200cm shaft lengths recited in the Diamondback360® brochure and generically recited without specific reference to length in Kallok modified by Shturman and Higgins. One of ordinary skill in the art, before the effective filing date of the claimed invention, could have implemented the claimed variation of Kallok modified by Shturman and Higgins with the known, commercially available shaft lengths taught by the Diamondback360® brochure, for shaft lengths of approximately 57 inches (e.g. 145 cm), and the claimed variation would have been predictable based on the teachings of the prior art and demonstrated commercial availability. Additionally, the difference in claims 2 and 3 arises in “a length of the unconstrained proximal-most drive shaft section with recited ranges of 0.5 to 3 inches” in claim 2 (the broader recitation) and the more narrow range of “1 to 2 inches”, in claim 3. Neither Kallok modified by Shturman and Higgins, nor the Diamondback360® brochure expressly teaches these ranges. However, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Even so, it is noted that the instant specification recites “[t]he length of the unconstrained proximal-most section 72 of the drive shaft 50 is a critical feature that balances the above-referenced functions and may be within a range of 0.5-3.0 inches, with 1-2 inches being preferred” (Specification, p. 12, ¶73). Accordingly, Applicant’s statement of criticality of these ranges in length for the proximal-most section of the drive shaft is recognized.
However, both claims 2 and 3 recite “a length” in line 2. The generic use of “a” (broadly interpreted as “any”) length “within the range”, which encompasses whole numbers of 1 to 2 inches (claim 3) and a 0.5 (one-tenth decimal place) to 3 inches (a whole number), brings the statement of criticality into question as to the precision of the range and its applicability to actual criticality, such that the examiner broadly interprets the criticality of the range as a rebuttable presumption, without more, in the absence of unexpected results.
There is express reason to question the criticality of the range that is stated in the very short 13-page specification itself, in the absence of supporting evidence. The rationale given in the Specification for the “criticality” of the broader range is that “the stated ranges strike the necessary balance for maintaining 1:1 motion control over the rotational position of the drive shaft and related tool T while providing the requisite strain relief” (Specification, p. 12, ¶73). The phase “strikes the necessary balance” is viewed as being more akin to the optimization of parameters necessary to affect a variable in the system, rather than being a critical range. Applicant is reminded that the burden is on the Applicant to establish that results are unexpected and significant.
As stated in MPEP 716.02(b):
“The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP 716.02(c).”
As discussed above, Kallok modified by Shturman and Higgins teach in the same field of endeavor as the instant application, that of motorized atherectomy devices comprising filars with polymeric coatings. There were design incentives or market forces which would have prompted adaptation of Kallok’s devices such that other known configurations of atherectomy devices would benefit from improved stability and strength, as taught by Kallok, by adding portions of polymeric coatings or jackets to portions of the filars or wire braids at the distal end of the device in order to improve its ability to remove stenotic lesions (Kallok: p. 12, lines 7-9; Shturman: FIGs 1 and 2; col 10, lines 8-17).
The differences between the claimed invention and the prior art were encompassed in known variations, such as the variability of the location of and the degree of jacketing or application of the polymeric coating to the filars or wire braids of atherectomy devices, as expressly taught by Kallok modified by Shturman. These variations, while numerous, are also finite in number and do not fall within the realm of undue experimentation. One of ordinary skill in the art, before the effective filing date of the claimed invention, could have implemented the claimed variation of Kallok modified by Shturman to alter the location and extent of polymeric jackets/coatings on the drive shaft for improved function and durability, and the claimed variation would have been obvious because “a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 4, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok teaches wherein the drive shaft comprises “a length” measured from the handle (p. 11, lines 26-27, drive shaft 136; FIG 1).
The recitation of “a length” in claim 4 is broadly interpreted as “any” length.
Kallok does not expressly teach “a length” of the unconstrained proximal-most drive shaft section as a percentage of the drive shaft length is within the range of 0.8% to 5.2%.
Regarding claim 5, Kallok modified by Shturman and Higgins teach the rotational atherectomy device of claim 1, as set forth above, for the reasons set forth above.
Kallok teaches wherein the drive shaft comprises a length measured from the handle (p. 11, lines 26-27, drive shaft 136; FIG 1).
The claimed recitation of “a length” in claim 5 is broadly interpreted as “any” length.
Kallok modified by Shturman and Higgins does not expressly teach “a length” of the unconstrained proximal-most drive shaft section as a percentage of the drive shaft length is within the range of 1.8% to 3.5%.
The Diamondback360® brochure teaches standard atherectomy device shaft lengths as being approximately 57 inches (145 cm = approximately 57.1 inches) (Table, page 1 of 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 Kallok, Shturman, Higgins, and the Diamondback360® brochure given that the prior art included each element claimed, although not necessarily in a single reference. Kallok modified by Shturman and Higgins and the Diamondback360® brochure teach in the same field of endeavor as the instant application, that of motorized atherectomy devices with drive shafts that are analogous devices to those of the instant claims. There were also design incentives or market forces which would have prompted adaptation of Kallok’s devices such that other known configurations of atherectomy devices would benefit, including shaft lengths of 145cm (approximately 57 inches) as taught by the Diamondback360® brochure. The differences between the claimed invention and the prior art were encompassed in known variations as taught by the 145cm, 180cm, and 200cm shaft lengths recited in the Diamondback360® brochure and generically recited without specific reference to length in Kallok modified by Shturman. One of ordinary skill in the art, before the effective filing date of the claimed invention, could have implemented the claimed variation of Kallok modified by Shturman with the known, commercially available shaft lengths taught by the Diamondback360® brochure, for shaft lengths of approximately 57 inches (e.g. 145 cm), and the claimed variation would have been predictable based on the teachings of the prior art and demonstrated commercial availability. Additionally, the difference in claims 4 and 5 arises in the recitation of “a length of the unconstrained proximal-most drive shaft section as a percentage of the drive shaft length is within the range of 0.8% to 5.2%” (the broader recitation) and the more narrow range of “1.8% to 3.5%”, in claim 5.
Neither Kallok modified by Shturman and Higgins nor the Diamondback360® brochure teach these ranges. However, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Unlike with the recitations related to claims 2 and 3, the instant specification is silent as to any criticality for the percent ranges to drive shaft length. Accordingly, these ranges are broadly considered results effective variables. A working section of a tool is dependent on the working section for the application of the device. There is nothing in the disclosure or of record to suggest that these ranges are unexpected or significant or are anything other than ranges for working sections of the tool that are optimizable as results effective variables. Applicant is reminded that the burden is on the Applicant to establish that results are unexpected and significant.
As discussed above, 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 Kallok, Shturman, Higgins, and the Diamondback360® brochure given that the prior art included each element claimed, although not necessarily in a single reference. Kallok modified by Shturman and Higgins teaches in the same field of endeavor, that of motorized atherectomy devices comprising filars with polymeric coatings. There were also design incentives or market forces which would have prompted adaptation of Kallok’s devices such that other known configurations of atherectomy devices would benefit from improved stability and strength, as taught by Kallok modified by Shturman and Higgins, by adding portions of polymeric coatings or jackets to portions of the filars or wire braids at the distal end of the device in order to improve its ability to remove stenotic lesions (Kallok: p. 12, lines 7-9; Shturman: FIGs 1 and 2; col 10, lines 8-17). The differences between the claimed invention and the prior art were encompassed in known variations, such as the variability of the location of, the degree of, and the percentage of jacketing or application of the polymeric coating (constraints) or their mirror, unconstrained segments, of filars of the atherectomy devices, as expressly taught by Kallok modified by Shturman and Higgins. The variations taught by Kallok modified by Shturman and Higgins, while numerous, are also finite in number and do not fall within the realm of undue experimentation. One of ordinary skill in the art, before the effective filing date of the claimed invention, could have implemented the claimed variation of Kallok modified by Shturman and Higgins to alter the location and extent of polymeric jackets/coatings on the drive shaft for improved function and durability, and the claimed variation would have been obvious because “a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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