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
The species restriction between species a and b is withdrawn as Beyar et al. (US 20060190022 A1) teaches that an optical fiber and laser shockwave source are obvious variants.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Applicant’s election without traverse of group I in the reply filed on 08/03/2026 is acknowledged.
Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/03/2026.
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.
Claims 2-5, 8-13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins et al. (US 20100114020 A1) in view of Beyar et al. (US 20060190022 A1).
Regarding claim 2 Hawkins discloses (fig. 3) an apparatus for treating a calcified region within a cardiovascular system of a patient (see abstract), the apparatus comprising: an elongate body (see annotated fig. 3 below); an inflatable balloon 24 disposed at a distal region of the elongate body (see fig. 3 and [0028]); and a shock wave source 34 that is movable within the inflatable balloon (see note below).
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Note: The language “shock wave source that is movable within the inflatable balloon” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Hawkins meets the structural limitations of the claim, and the shock wave source is capable of being movable within the inflatable balloon. The shockwave source is positioned on member 32 which is separate and disconnected from the balloon therefore it is capable of being movable within the inflatable balloon.
Hawkins is silent regarding the shock wave source comprises an optical fiber.
However Beyar, in the same field of endeavor, teaches a shock wave source comprises an optical fiber 230 (see [0271]).
Therefore, the substitution of one known shockwave source (optical fiber as taught in Beyar) for another (electrodes as taught in Hawkins) would have been obvious to one of ordinary skill in the art at the time of the invention since Beyar the substitution of the optical fiber as taught in Beyar would have yielded predictable results, namely, a shockwave source that would provide shockwaves to the balloon. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 10 Hawkins discloses (fig. 3) an apparatus for treating a calcified region within a cardiovascular system of a patient (see abstract), the apparatus comprising: an elongate body (see annotated fig. 3 below); an inflatable balloon 24 disposed at a distal region of the elongate body (see fig. 3 and [0028]); and a shock wave source 34 that is movable within the inflatable balloon (see note below).
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Note: The language “shock wave source that is movable within the inflatable balloon” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Hawkins meets the structural limitations of the claim, and the shock wave source is capable of being movable within the inflatable balloon. The shockwave source is positioned on member 32 which is separate and disconnected from the balloon therefore it is capable of being movable within the inflatable balloon.
Hawkins is silent regarding the shock wave source comprises a laser.
However Beyar, in the same field of endeavor, teaches a shock wave source comprises a laser (see [0271]).
Therefore, the substitution of one known shockwave source (laser as taught in Beyar) for another (electrodes as taught in Hawkins) would have been obvious to one of ordinary skill in the art at the time of the invention since Beyar the substitution of the laser as taught in Beyar would have yielded predictable results, namely, a shockwave source that would provide shockwaves to the balloon. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claims 3 and 11, Hawkins as modified discloses the claimed invention substantially as claimed, as set forth above for claims 2 and 10. Hawkins discloses (fig. 3) an elongate member 32 disposed at least partially within the elongate body (see fig. 3), wherein the shock wave source is disposed at a distal portion of the elongate member (see fig. 3 and [0028]).
Regarding claims 4 and 12, Hawkins as modified discloses the claimed invention substantially as claimed, as set forth above for claims 2 and 10. Hawkins discloses (fig. 3) the shock wave source 34 is movable within the inflatable balloon along a longitudinal axis of the elongate body. The language “shock wave source is movable within the inflatable balloon along a longitudinal axis of the elongate body” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Hawkins meets the structural limitations of the claim, and the shock wave source is capable of being movable within the inflatable balloon along a longitudinal axis of the elongate body. The shockwave source is positioned on member 32 which is separate and disconnected from the balloon therefore it is capable of being is movable within the inflatable balloon along a longitudinal axis of the elongate body.
Regarding claims 5 and 13, Hawkins as modified discloses the claimed invention substantially as claimed, as set forth above for claims 2 and 10. Hawkins discloses (fig. 3) the shock wave source 34 is rotatable within the inflatable balloon around a longitudinal axis of the elongate body. The language “shock wave source is rotatable within the inflatable balloon around a longitudinal axis of the elongate body” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Hawkins meets the structural limitations of the claim, and the shock wave source is capable of being rotatable within the inflatable balloon around a longitudinal axis of the elongate body. The shockwave source is positioned on member 32 which is separate and disconnected from the balloon therefore it is capable of being rotatable within the inflatable balloon around a longitudinal axis of the elongate body.
Regarding claims 8 and 15, Hawkins as modified discloses the claimed invention substantially as claimed, as set forth above for claims 2 and 10. Hawkins discloses (fig. 3) a plurality of shock wave sources (34, 36, see fig. 3 and [0028]).
Regarding claims 9 and 16, Hawkins as modified discloses the claimed invention substantially as claimed, as set forth above for claims 2 and 10. Hawkins discloses (fig. 3) a second elongate member (see annotated fig. 3 below), a second inflatable balloon 26, and a second shock wave source 36 (see fig. 3 and [0028]) that is movable within the second inflatable balloon. The language “second shock wave source that is movable within the second inflatable balloon” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Hawkins meets the structural limitations of the claim, and the second shock wave source is capable of being movable within the second inflatable balloon. The second shockwave source is positioned on member 32 which is separate and disconnected from the second balloon therefore it is capable of being movable within the second inflatable balloon.
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 6, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 17 of U.S. Patent No. 12,310,605 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of claims 2, 6, 10, and 14 are claimed by claims 14 and 17 of U.S. Patent No. 12,310,605 B2, as outlined below.
Claims of instant application
Claims of 11,766,271
2
14
3
1
6
14
10
17
11
1
14
17
Claims 2-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, 13, and 16 of U.S. Patent No. 12,310,605 B2 in view of Beyar et al. (US 20060190022 A1).
Regarding claim 2, US 12,310,605 claim 1 claims an apparatus for treating a calcified region within a cardiovascular system of a patient (see col. 14 ln. 6-8), the apparatus comprising: an elongate body (catheter, see col. 14 ln. 9); an inflatable balloon disposed at a distal region of the elongate body (see col. 14 ln. 14-16); and a shock wave source that is movable within the inflatable balloon (see col. 14 ln. 14-16).
US 12,310,605 claim 1 fails to claim the shock wave source comprises an optical fiber.
However Beyar, in the same field of endeavor, teaches a shock wave source comprises an optical fiber 230 (see [0271]).
Therefore, the substitution of one known shockwave source (optical fiber as taught in Beyar) for another (as taught in US 12,310,605 claim 1) would have been obvious to one of ordinary skill in the art at the time of the invention since Beyar the substitution of the optical fiber as taught in Beyar would have yielded predictable results, namely, a shockwave source that would provide shockwaves to the balloon. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 10, US 12,310,605 claim 1 claims an apparatus for treating a calcified region within a cardiovascular system of a patient (see col. 14 ln. 6-8), the apparatus comprising: an elongate body (catheter, see col. 14 ln. 9); an inflatable balloon disposed at a distal region of the elongate body (see col. 14 ln. 14-16); and a shock wave source that is movable within the inflatable balloon (see col. 14 ln. 14-16).
US 12,310,605 claim 1 fails to claim the shock wave source comprises a laser.
However Beyar, in the same field of endeavor, teaches a shock wave source comprises a laser (see [0271]).
Therefore, the substitution of one known shockwave source (laser as taught in Beyar) for another (as taught in US 12,310,605 claim 1) would have been obvious to one of ordinary skill in the art at the time of the invention since Beyar the substitution of the laser as taught in Beyar would have yielded predictable results, namely, a shockwave source that would provide shockwaves to the balloon. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claims 3 and 11, US 12,310,605 claim 1 claims an elongate member disposed at least partially within the elongate body, wherein the shock wave source is disposed at a distal portion of the elongate member (see col. 14 ln. 10-13).
Regarding claims 4 and 12, US 12,310,605 claim 2 claims the shock wave source is movable within the inflatable balloon along a longitudinal axis of the elongate body (see col. 14 ln. 18-20).
Regarding claims 5 and 13, US 12,310,605 claim 3 claims the shock wave source is rotatable within the inflatable balloon around a longitudinal axis of the elongate body (see col. 14 ln. 21-23).
Regarding claims 6 and 14, US 12,310,605 claim 1 claims an actuator configured to move the shock wave source (see col. 14 ln. 17).
Regarding claim 7, US 12,310,605 claim 9 claims the actuator comprises a knob (see col. 14 ln. 38-39).
Regarding claims 8 and 15, US 12,310,605 claim 13 claims a plurality of shock wave sources (see col. 14 ln. 56-59).
Regarding claims 9 and 16, US 12,310,605 claim 16 claims a second elongate member, a second inflatable balloon, and a second shock wave source that is movable within the second inflatable balloon (see col. 14 ln. 56-59).
Allowable Subject Matter
Claims 6, 7, and 14 would be allowable if a terminal disclaimer is filed to overcome the double patenting rejections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious an actuator configured to move the shock wave source.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H Mendez whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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