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 C (Figs. 100-100E), in the reply filed on 12/16/2025 is acknowledged.
Allowable Subject Matter
Claims 1-5, 7-9 are allowed over prior art.
Claims 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable over prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Please note claims 1-5, 7-9, 18-19 are subject to a nonstatutory double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter: Prior art Ryan et al. (Pub. No.: US 2009/0192591) discloses discrete commissure markers 60, however, these markers are not arranged on an attachment member that is arranged across a selected cell.
Prior art Bell et al. (Pub. No.: US 2015/0209140) discloses markers 204 corresponding to commissure points (e.g., fig. 6) and leaflet commissures sutured to cells (28, e.g., fig. 1A, 1B, para. 26). Bell lacks a radiopaque marker arranged on an attachment member that is arranged across a stent cell.
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 1-5, 7-9, 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, 10 of U.S. Patent No. 11,806,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the patent claims. Here, all of the elements of application claims 1-5, 7-9, 18-19 are found in patent claims 1-5, 7-8, 10. The differences between the claims are that the patent claims include many more elements and thus are more specific. Thus, the invention of claims 1-5, 7-8, 10 of the patent are in effect a “species” of the “generic” invention of application claims 1-5, 7-9, 18-19. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 1-5, 7-9 are anticipated by patent claims 1-5, 7-8, 10, the claims are not patentably distinct.
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.
Claims 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan et al. (Pub. No.: US 2009/0192591).
Ryan et al. (hereinafter, Ryan), discloses a prosthetic heart valve comprising: a frame 52 (e.g., fig. 2) including a plurality of struts forming a plurality of cells of the frame (e.g., fig. 2); a plurality of leaflets 54 arranged within the frame (e.g., fig. 2), wherein adjacent pairs of the plurality of leaflets form commissures (para. 35), and wherein each commissure is disposed within a selected cell of the plurality of cells (e.g., fig. 2, para. 35); and a plurality of radiopaque markers 60, wherein each radiopaque marker is aligned with a respective commissure and suspended within a respective selected cell (e.g., fig. 2, para. 35).
For claim 17, Ryan discloses the prosthetic heart valve of claim 16, wherein each radiopaque marker 60 is reflection asymmetric across an axis that is parallel to a central longitudinal axis of the frame, the central longitudinal axis extending between an inflow end and outflow end of the frame (e.g., fig. 2).
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774