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
Applicant's election without traverse of Group I in the reply filed on 2/11/2026 is acknowledge
Applicant’s election with traverse of Species B in the reply filed on 2/11/2026 is acknowledged. The traversal is on the ground(s) that the species are not distinct and there is not a search burden because “any reasonable and logically crafted search” for paired or grouped emitters (species B) would also return results for individual emitters (species A or Species D), and any reasonable and logically crafted search for concentrically stacked emitter carriers (Species A) would also return results for carriers circumferentially arranged next to each other (Species D). This is not found persuasive because each species has mutually exclusive characteristics that require the use of different search queries including the use of different search terms (e.g., Species B: “paired”, “pair”, “group”, “simultaneous” versus Species A or D: “single”, “independent”, “individually”; e.g., Species A: “concentric”, “concentrically”, “stacked”, “coaxial” versus Species D: “circumferentially adjacent”, “adjacent”, “non-overlapping”). With respect to Species C, the examiner maintains that Species C is indeed distinct from species A, B, D, and E because Species C, as illustrated in figs. 2a-2c, includes multiple shock wave emitters fixed to a single carrier, the carrier movable to move all of the emitter simultaneously such that no emitters are able to move relative to any other emitters on the device. No particular arguments are not presented with respect to Species E. Claims 1-11 read on species B. Claims 12-17 are withdrawn as being drawn to non-elected species E.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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, 4-5, 7-8 and 11 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Hawkins et al. (US 2016/0135828). Hawkins discloses a catheter for treating an occlusion in a body lumen, the catheter comprising: an elongate tube (right-most 104 in fig. 1b) extending in a longitudinal direction from a distal region to a proximal region; a flexible enclosure (102 attached to right-most 104 in fig. 1b) at least partially secured to the distal region of the elongate tube; a first shock wave emitter (108 within right-most 102 in fig. 1b) located along the elongate tube (right-most 104 in fig. 1b) and a second shock wave emitter (108 in one of the adjacent 102s) located along the elongate tube (noting the term “along” is being given its broadest reasonable interpretation of “in the same direction as, or beside”) and translatable in the longitudinal direction relative to the first shock wave emitter (noting each elongate carrier 104, on which a shock wave emitter 108 is secured, can be individually advanced or retracted over its respective positioning wire 106 as per [0052]). .
Regarding claim 4, the first shock wave emitter comprises a first plurality of shock wave emitters (two 108 on right-most 104 in fig. 1b) and the second shock wave emitter comprises a second plurality of shock wave emitters (two 108 on another one of 104) that is translatable as a group relative to the first plurality of shock wave emitters (movement controlled by respective 104).
Regarding claim 5, the catheter further comprises a third shock wave emitter (108 in third one of balloons 102) that is independently translatable relative to the first and second shock wave emitters ([0052]).
Regarding claim 7, the first shock wave emitter is translatable in the longitudinal direction ([0052]).
Regarding claim 8, the catheter further comprising a proximal handle that is configured to control movement of at least one of the first shock wave emitter and the second shock wave emitter (“proximal control” considered proximal handle; [0052]).
Regarding claim 11, each of the first and second shock wave emitters comprises one or more electrode pairs and each of the one or more electrode pairs comprises an outer electrode and an inner electrode (shown in more detail with respect to emitter 400 in fig. 4: inner electrode 406 and outer electrode 408).
Claim(s) 1, 2, 7-8 and 11 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Adams et al. (US 2016/0151081). Adams discloses a catheter (figs. 8, 9) for treating an occlusion in a body lumen, the catheter comprising: an elongate tube (123) extending in a longitudinal direction from a distal region to a proximal region; a flexible enclosure (122) at least partially secured to the distal region of the elongate tube (fig. 8); a first shock wave emitter (131, noting 131 can be retracted into 123) located along the elongate tube; and a second shock wave emitter (130) located along the elongate tube and translatable in the longitudinal direction relative to the first shock wave emitter (noting arrows in figs 8, 9; via control knobs 160 and 180; [0060]).
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. In particular, the emitters of Adams are free to move relative to each other a distance equal to the working length d of the balloon since emitter 130 is capable of being withdrawn relative to the balloon and elongate tube 123 until it is spaced from emitter 131 by a spacing equal to the working length of the balloon (i.e., there is no structure blocking proximal withdrawal of emitter, via the control structure shown in fig. 9, from the configuration shown in fig. 8 until the emitter 130 is spaced from emitter 131 by a distance equal to d.)
Regarding claim 7, the first shock wave emitter is translatable in the longitudinal direction (see arrows at control knobs 160/180 in fig. 9; [0060]).
Regarding claim 8, the catheter further comprising a proximal handle (160; fig. 9) that is configured to control movement of at least one of the first shock wave emitter and the second shock wave emitter.
Regarding claim 11, 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]).
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) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Hawkins et al. (US 2016/0135828). Regarding claims 3 and 4, Adams discloses the invention substantially as stated above including a second shockwave emitter translatable in relation to the first shock wave emitter, but fails to expressly disclose that the first shockwave emitter includes a first pair of shockwave emitters and the second shock wave emitter includes a second pair of shockwave emitters.
Hawkins discloses another catheter that includes a first shock wave emitter comprising a first pair of shock wave emitters (note two 108 on a first 104) and a second shockwave emitter comprising a second pair of shockwave emitters (note two 108 on a second 104), the second pair of shockwave emitters translatable as a pair (via movement of second 104) relative to the first pair of shock wave emitters. It would have been obvious to one of ordinary skill in the art to have modified the first and second shockwave emitters (131, 130) of Adams, which are translatable relative to each other, to include first and second pairs of shockwave emitters, respectively, as taught by Hawkins, in order to be able to deliver shockwaves to multiple areas from each of the first and second emitters, thereby decreasing the time of the procedure. With respect to claim 4, each pair of emitters is considered a plurality of emitters as plurality merely means more than one.
Regarding claim 5, Hawkins further teaches a third shockwave emitter (108 on third 104) that is independently translatable relative to the first and second shock wave emitters in order to provide simultaneous treatment to all three leaflets of a tricuspid cardiac valve and thus it would have been obvious to have modified the prior art of Adams to include a third shockwave emitter as claimed in view of Hawkins so that it too may be used to simultaneously treat all three leaflets of a tricuspid valve.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Casiraro (WO 2022/098363 A1, corresponds to US 2023/0397925; citations taken from ‘925). 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), 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 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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Cribier et al. (US 4,777,951). Adams discloses the invention substantially as stated above but is silent on the length of the balloon.
Cribier disclose a balloon that, like the balloon of Adams, is used to treat a calcified valve. Cribier discloses that the balloon may have a length of 60mm (2cm + 3cm + 0.5cm + 0.5cm = 6cm; 60mm) (see col. 6, ll. 18-35). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Adams to size the balloon to have a working length of at least 50 mm, in particular a length of 60mm, in view of Cribier’s teaching that a length of 60mm is known in the art as suitable for a balloon used for dilation of a calcified valve, and therefore the results of such modification 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 Adams in view of McCaffrey et al. (US 2020/0129196). Adams discloses the invention substantially as stated above including a safety stop fixedly located on the elongate tube. In particular, yoke assembly 150 (fig. 9), which is fixed to the proximal end of the elongate tube, can be considered a safety stop as it stops advancement of sheaths 138,139 when their respective control knobs 158,160 abut extensions 154,156 of the yoke, and 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. 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 Adams to construct the stop (150) 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 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 3/5/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771