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 .
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 and 26-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, from which claims 2-11 and 26-35 depend, has been amended to require that the flexible enclosure is at least partially secured at the proximal and distal ends to the distal region of the elongate tube. This limitation is not supported in the application as originally filed. If inner shaft (106), which is tubular, is considered the claimed elongate tube, the flexible enclosure (balloon 108 or 109) is secured at its distal end to the distal region of the elongate tube 106, but is not secured at its proximal end to the distal region of elongate tube 106. Instead, the proximal end of the flexible enclosure is secured to outer shaft (102). If outer shaft (102) is considered the claimed elongate tube, the flexible enclosure is secured at its proximal end to the distal region of the elongate tube 106, but is not secured at its distal end to the distal region of elongate tube (102). Additionally, the first and second emitters are not located proximally of a distal end of the outer shaft (102). See also paragraph [0073], which discloses that the balloon has a proximal end attached to an outer balloon shaft and a distal end attached to an inner shaft. Thus, the application as originally filed fails to disclose a flexible enclosure at least partially secured at distal and proximal ends to the distal region of an elongate tube. Rather, the application as originally filed discloses a flexible enclosure secured to a first elongate tube (106) at the flexible enclosure’s distal end and secured to a different elongate tube (102) at the flexible enclosure’s proximal end.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-5, 7-8, 10-11, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US 2016/0184570; “Grace”) in view of Adams et al. (US 2016/0151081). Grace discloses a catheter (fig. 8.) for treating an occlusion in a body lumen, the catheter comprising: an elongate tube (sheath 612) extending in a longitudinal direction from a distal region to a proximal region; a flexible enclosure (balloon 616) at least partially secured at distal and proximal ends to the distal region of the elongate tube (fig. 8; [0157]); a first shock wave emitter (electrode assembly 650) located within the flexible enclosure and along the elongate tube proximally of the a distal end of the elongate tube; and a second shock wave emitter (electrode assembly 654) located within the flexible enclosure and along the elongate tube proximally of the distal end of the elongate tube and translatable in the longitudinal direction via translation of the inner sheath (608). Grace fails to disclose that the second shock wave emitter is translatable in the longitudinal direction relative to the first shock wave emitter.
Adams another catheter for treating an occlusion in a body lumen wherein first and second shock wave emitters (130,131; fig. 8) are located within a balloon (122) of the catheter. Adams discloses that the first and second shockwave emitters (130,131) are separately rotatable and translatable (via handles 160,180; fig. 9) in the longitudinal direction such that the second shockwave emitter is able to rotate and translate in the longitudinal direction relative to the first shock wave emitter in order to adjust the distance of the emitters relative to each other and to tissue to be treated in order to maximize available shock wave energy when desired ([0057], [0059]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Grace to construct the second shock wave emitter such that it is translatable in the longitudinal direction relative to the first shock wave emitter in view of Adams in order to increase the number of configurations in which the emitters can be disposed within the balloon, thereby allowing greater adjustability in the amount of shock wave energy that can be delivered to target tissue.
Regarding claim 2, the flexible enclosure (balloon 122) has a working length d, and a center-to-center distance between the first shock wave emitter and the second shock wave emitter is adjustable between 2 mm and d. Grace discloses that the first and second emitters may be 3mm apart ([0129]). Since Adams teaches emitters that are free to move relative to each other, with no structure blocking proximal withdrawal of either emitter, via the control structure shown in fig. 9, until the emitters are spaced apart by a distance equal to d, it would have been obvious to construct the device of Grace as modified by Adams to allow the shockwave emitters to be adjustably spaced apart by a distance d if desired.
Regarding claims 3 and 4, Grace discloses a first shockwave emitter comprising a first pair/plurality of shockwave emitters (650, 652), and a second shockwave emitter comprising a second pair/plurality of shockwave emitters (654,656). Adams teaches independently movable shockwave emitters (130,131) such that each shockwave emitter may be independently translated relative to the other via their own control handles and thus it would have been obvious to provide each of the electrode assemblies (i.e., each of 650, 652, 654, 656, 668) of Grace with its own means of movement control for the predictable result of increasing the number of configurations in which the emitters can be disposed within the balloon, thereby allowing the treatment to be tailored to the specific lesion being treated. When each electrode assembly is independently controlled, second pair (654,656) of shockwave emitters can be translatable as a pair relative to the first pair (650,652) of shock wave emitters.
Regarding claim 5, Grace discloses a third shockwave emitter (658) and in view of Adams teaching that shockwave emitters provided in a balloon may be independently translated relative to one another, it would have bene obvious to construct the third shockwave emitter so that it too can be independently translated for the predictable advantage of being able to move the emitters into a configuration best suited for treatment of a lesion of interest.
Regarding claim 7, the first shock wave emitter is translatable in the longitudinal direction as taught by Adams (see arrows at control knobs 160/180 in fig. 9; [0060] of Adams).
Regarding claim 8, Adams further teaches a proximal handle (160; fig. 9 of Adams) that is configured to control movement of at least one of the first shock wave emitter and the second shock wave emitter and such a modification to the prior art of Grace would have been obvious in order to facilitate easy user control over the relative positions of the emitters.
Regarding claim 10, Grace discloses a balloon having a working length of at least 50 mm (see [0129] – 60 mm).
Regarding claim 11, Grace discloses that each shock wave emitter comprises an electrode assembly, but is silent on the exact structure of the electrode assemblies of the embodiment shown in fig. 8. Adams further teaches that each of the first and second shock wave emitters comprises one or more electrode pairs (pair 132 and pair 133) and each of the one or more electrode pairs comprises an outer electrode and an inner electrode (e.g., 66, 64 in fig. 6; [0056], [0054]). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Grace to construct each of the electrode assemblies of the shockwave emitters to comprise an inner electrode and an outer electrode in view of Adams’ teaching that such a configuration is known in the art as a suitable construction for a shockwave emitter that uses an electrode assembly to produce an electrical arc and thus the results of such a modification would have been predictable and one skilled in the art would have had a reasonable expectation of success.
Regarding claim 26, Grace discloses a first, second, third, and fourth shockwave emitter (e.g., 650, 652, 654, 656). In view of Adams teaching that it is known to provide a plurality of shockwave emitters (130,131) such that they can be independently translatable relative to each other (see figs. 8, 9), it would have been considered obvious to one of ordinary skill in the art to have modified the prior art of Grace to construct each of the four shockwave emitters such that they can be independently translated relative to the other three shockwave emitters for the predictable result of providing greater adjustability with respect to the configuration of the emitters, thus allowing the configuration to be tailored to the specific lesion being treated by the catheter.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Adams as applied to claim 8 above and further in view of Casiraro (WO 2022/098363 A1, corresponds to US 2023/0397925; citations taken from ‘925). Grace in view of Adams discloses the invention substantially including a first actuator (180) for controlling movement of the first shock wave emitter (131) and a second actuator (160) for controlling movement of the second shock wave emitter (130) as taught by Adams (see figs. 8, 9), but fails to disclose that the first and second actuators comprise first and second thumbwheel ratchets.
Casiraro discloses another balloon catheter and further discloses that the actuator (40) for controlling advancement and retraction of an elongate member (30) relative to the balloon (12) takes the form of a thumbwheel ratchet (44/46; see figs. 5, 5a and [0035]), as an alternative to a slide (42; see fig. 4).
It would have been obvious to one of ordinary skill in the art to have modified the first and second actuators of the prior art of Grace as modified by Adams to comprise first and second thumbwheel ratchets in view of Casiraro’s teaching that a thumbwheel ratchet is known in the art as a suitable actuator for controlling advancement and retraction of an elongate member relative to a balloon and thus such a modification can be considered a substitution of one known actuator for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Adams as applied to claim 5 above and further in view of McCaffrey et al. (US 2020/0129196). Grace in view of Adams discloses the invention substantially as stated above including a safety stop fixedly located on the elongate tube. In particular, as taught by Adams, yoke assembly 150 (fig. 9) attached to the proximal end of the device can be considered a safety stop as it stops advancement of emitters 130,131 when their respective control knobs 160,180 abut knobs 158,160, stopped by extensions 154,156 of the yoke as understood in view of fig. 9 of Adams. Grace in view of Adams does not expressly disclose that the safety stop is configured to space the first and second shock wave emitters by a center-to-center distance of no less than 2mm.
McCaffrey discloses another catheter configured to deliver shockwaves to tissue, the catheter including shockwave emitters (26). McCaffrey teaches that the shockwave emitters should be separated by a longitudinal distance of at least about 2 mm in order to allow the emitters to functional independently of one another such that the electrical signal does not pass from an electrode of one emitter to an electrode of the other emitter ([0111]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Grace in view of Adams to construct the stop (150 of Adams) such that it is configured to space the first and second shockwave emitters by a center-to-center distance of no less than 2mm when fully advanced as in view of the teachings of McCaffrey in order to ensure that the emitters are able to function independently of one another such that the electrical signal does not pass from one emitter to the other.
Claim(s) 27-28 and 30-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Adams as applied to claim 1 above and further in view of Hawkins et al. (US 2016/0135828). Regrading claims 27 and 30-32, Grace in view of Adams discloses the invention substantially including first, second, third, fourth and fifth shock wave emitters (e.g., 650, 652, 654, 656, 658 of Grace; fig. 6). Adams teaches that it is known to include a plurality of shockwave emitters (130,131) within a balloon (122; fig. 8, 9) that are independently translatable relative to each other. It would have been obvious to modify the first, second, third, fourth, and fifth shock wave emitters of Grace such that they are each independently translatable relative to each other in order to provide the predictable result of increasing the number of configurations in which the emitters can be disposed relative to each other within the balloon, thereby allowing the treatment to be tailored to the specific lesion being treated. Grace in view of Adams does not expressly disclose that each of the first, second, third, fourth, and fifth shock wave emitters are configured to connect to a channel of the power source separate from electrical channels connected to the other four shock wave emitters, though Grace does disclose that the high-voltage connector (160) may have pins that connect each of the wires from the electrode assemblies to the appropriate channels on a high voltage pulse generator ([0128]).
Hawkins discloses another catheter having a plurality of shock wave emitters (108; fig. 1b). Hawkins discloses that one of the electrodes of each shock wave emitter may be connected to a separate voltage channel in a direct connect configuration such that shockwaves originating from each emitter may be activated separately ([0061], [0034]). According to Hawkins, it may be desirable to control shockwave emitters independently in order to target specific portions of a calcification ([0061]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Grace in view of Adams to connect each of the first, second, third, fourth and fifth shock wave emitters to a separate channel of the power source (i.e., voltage channel) separate from electrical channels connected to each of the other four shock wave emitters as taught by Hawkins in order to be able to target specific portions of a calcification by activating only those emitters closest to the targeted portion of the calcification.
Regarding claim 28, the power source is a high voltage power supply electrically connected to the first and second shockwave emitters by wires ([0034] of Hawkins; see also high voltage pulse generator 90 and par. [0128] of Grace).
Regarding claims 33 and 34, Grace in view of Adams and Hawkins discloses that each shock wave emitter is configured to independently receive a voltage of 100 to 10,000 volts ([0132]), which encompasses the claimed range, and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Circ. 1990).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Adams as applied to claim 1 above and further in view of DuChamp (US 2002/0082553). Grace in view of Adams discloses the invention substantially as stated above including a taper in the proximal to distal direction near the distal end of the balloon, but fails to disclose that the taper angle is up to 20 degrees.
DuChamp discloses another balloon that can be used to dilate a blood vessel at a location of a lesion and further teaches that the distal taper (46; fig. 2), where the balloon tapers in a proximal to distal direction to connect to the catheter tube, may have a tapering angle of 15.3 to 22.3 degrees ([0012]; claim 4), which overlaps the claimed range of “up to 20 degrees”. According to DuChamp, such an angle provides flexibility of the catheter at the distal end of the balloon while maintaining the strength of the bond between the catheter and the balloon material ([0004]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Grace to construct the flexible enclosure (balloon) to provide the taper near its distal end with a tapering angle of up to 20 degrees in view of DuChamp’s teaching that such a tapering angle is known in the art to provide flexibility of the catheter at the distal end of the balloon while maintaining the strength of the bond between the catheter and the balloon material, and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Circ. 1990).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Adams as applied to claim 1 above and further in view of Grace et al. (US 2016/0184023; “Grace ‘023”). Grace in view of Adams discloses the invention substantially except for the power source being a laser-based power supply connected to the first and second shock wave emitters by optical fibers, noting that the shockwave emitters of grace are electrode assemblies.
Grace ‘023 discloses shock wave emitters (310,320,330; figs. 3a-3c) that emit laser light energy, wherein the emitters are connected to a laser-based power supply (230) by optical fibers ([0231]; [0235], [0257]). It would have been considered obvious to one of ordinary skill in the art to have modified the prior art of Grace in view of Adams to replace the arcing electrode assembly type shockwave emitters for laser light shockwave emitters as taught by Grace ‘023 since such a modification can be considered a simple substitution of one known emitter that generates cavitation bubbles and produces pressure waves to treat lesions in a blood vessel for another wherein the results of such a modification are predictable and one skilled in the art would have had a reasonable expectation of success.
Conclusion
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.
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KSH 7/31/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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