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
Applicant’s election without traverse of species A1-B1-C1, claims 163-165, 167-174, 176-181, 186-187, in the reply filed on 3/17/26 is acknowledged.
Claims 166, 175, 182-185 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/17/26.
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) 163-165, 167-169, 174, 176, 179-181, 186-187 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross (US 2021/0283397).
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Regarding claim 163, Gross discloses the same invention as claimed (Figures 1A and 14C shown above for example), including a prosthetic cardiac valve (abstract), which is configured to be delivered to a native cardiac valve of a patient in a constrained delivery configuration (Figure 4A), and which comprises: a frame (Figures 1A, 4A) which comprises interconnected stent struts arranged to define interconnected stent cells (Figure 1A); a plurality of prosthetic leaflets coupled to the frame to allow blood flow in a downstream direction and inhibit blood flow in an upstream direction when the prosthetic cardiac valve is in an expanded deployment configuration (Figures 1A-B); circuitry which is mechanically coupled to the frame (Paragraph 404); first and second electrodes which are mechanically coupled to the frame (abstract: e.g. cathode, anode; Paragraph 438: e,g, multiple cathodes); a printed circuit board which is shaped so as to define an elongate portion (Paragraph 404; Figure 2: 40) which is branched so as to define a main elongate portion and two or more branched elongate portions branching from the main elongate portion, wherein first and second ones of the branched elongate portions are coupled to the first and second electrodes, respectively (Figure 14C); and at least one electrical lead, which electrically couples the electrodes to the circuitry, and which is integral with the elongate portion of the PCB, and wherein the elongate portion of the PCB is mechanically coupled to some of the interconnected stent struts of the frame (Figure 14C).
Regarding claim 164, Gross discloses more than two branched elongate portions as recited (Figure 14C).
Regarding claim 165, Gross discloses first and second leads as recited (Figure 14C; anode and cathode would require separate leads).
Regarding claims 167-168, Gross discloses electrodes at different angular locations and same axial location as recited (Paragraph 438).
Regarding claim 169, Gross discloses the lead is encased as recited (Paragraphs 404, 411).
Regarding claim 174, Gross discloses upstream electrodes as recited (Paragraph 38).
Regarding claim 176, Gross discloses a rectangular cross-section as recited (Figure 5; Paragraph 349).
Regarding claim 179, Gross discloses suturing as recited (Paragraph 420: incorporation by reference to Dagan US 9526637).
Regarding claim 180, Gross discloses an aortic valve as recited (abstract).
Regarding claim 181, Gross discloses circuitry downstream and electrodes upstream as recited (Paragraph 38; Figure 1A).
Regarding claims 186-187, Gross discloses pacing with the electrodes as recited (Paragraph 161).
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.
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) 173, 177, 178 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 2021/0283397).
Regarding claims 173, 177, 178, Gross does not explicitly disclose thickness ratios as recited. However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and MPEP 2144.05(II)(A). Gross discloses the same general conditions of a prosthetic heart valve with struts and electrical components, and it does not appear that the particular thickness ratios yield new or unexpected results. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Gross to include the particular ratios as recited, since this would have amounted to merely finding the optimum or working ranges by routine experimentation.
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 163-165, 167-174, 176-181, 186-187 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,975,203. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the instant application.
Instant application
Patent
163-165
1
167-169
7-11, 21
170-172
2
173
5, 6
174
22
176
4
177-178
5, 6
179
15
180-181
1
186-187
3
Allowable Subject Matter
Claims 170-172 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and a terminal disclaimer is filed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gross (US 2019/0209302) shows a prosthetic valve pacing system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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, Carl Layno can be reached on 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3792
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