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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 12, 15-17, and 20-31 is/are pending. Claim(s) 23-31 is/are withdrawn. Claim(s) 1-11, 13-14, and 18-19 is/are canceled.
Allowable Subject Matter
Claim(s) 16 and 21 are allowable over the prior art and would be allowable is the non-prior art rejections are addressed and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, filed 1/22/2026, with respect to the Double Patenting Rejections have been fully considered and are persuasive. The Double Patenting Rejections of claims 12, 15-17, and 20-22 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments with respect to the 35 USC 112(f) interpretation of “flexible stabilizing mechanism” that as amended, to “stabilizing tool,” the language no longer invokes 112(f) are persuasive. Thus, the 35 USC 112(f) invoked interpretation is moot.
Applicant's arguments with respect to the prior art filed 1/22/2026 have been fully considered but they are not persuasive.
Applicant argues that claim 12 has been amended to include "each attachment feature comprises a docking post anchorage that is disposed between the two docking posts" and thus the claims are patentable (Applicant's Response on 1/22/2026, page 8).
The Examiner notes this language was previously in claims 13 and 18. Applicant has made no arguments that the prior art rejection of these claims was improper for any reason.
Claim Rejections - 35 USC § 102/103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 12, 15, 17, 20, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Shaolian, et al (Shaolian) (US 2016/0120642 A1).
Regarding Claim 12, Shaolian teaches an annuloplasty ring (e.g. Figures 9A-F, 13A-I, #1350) comprising:
a body member (e.g. Figure 13E, less docking post and anchors as noted below) having an elongate insertion geometry and an annular operable geometry (e.g. [0169], elongated for insertion and annular as shown in Figures 13H) and comprising a first end and a second end opposite the first end (e.g. Figure 13H), wherein the first end is not engaged to the second end in the elongate insertion geometry (not shown for the embodiment of Figures 13A-I, but shown for Figures 9C-D) and the first end and the second end are engaged in the annular operable geometry (e.g. Figures 13B-C);
a plurality of anchors housed within the body member in both the elongate insertion geometry and the annular operable geometry (e.g. Figures 1A to 1B, [0218], [0223]); and
one or more attachment features coupled to the body member (e.g. Figures 13E, H; #s 1355a, b are considered one attachment feature), wherein each attachment feature comprises two docking posts disposed on opposing sides of the attachment feature (e.g. Figure 13E, opening edges, hinge, and portions extending away from the annuloplasty ring), each docking post comprising an aperture (e.g. Figures 13H-I, opening portion) configured to receive a deactivation wire (as the structure is an aperture, it is able to have a wire pass therethrough),
wherein each attachment feature comprises a docking post anchorage that is disposed between two docking posts (e.g. Figure 3H, structure between posts), the docking post anchorage comprising an aperture (e.g. Figure 13D, one of the additional apertures shown) configured to attach a stabilizing tool (e.g. Figure 13A shows the flexible stabilizing mechanism; Figure 13D shows how it can connect to the anchorage portion).
Both the embodiments of Figures 1 and 13 are concerned with the same field of endeavor as the claimed invention, namely annuloplasty rings delivered in a linear configuration and made annular at the implantation site.
If not inherent that the annuloplasty ring of Figures 1A-1B is used with the stabilizing device as in Figures 13A-I, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the embodiment of the combination of the annuloplasty ring and delivery tool of Figures 13A-I such that the ring has the anchors as taught in Figures 1A-B in order to fasten the annuloplasty ring to the tissue at the implantation site (e.g. [0087]).
Regarding Claim 15, the one or more attachment features are integral with the body member (e.g. Figures 13E, H).
Regarding Claim 17, Shaolian teaches an annuloplasty ring delivery system (discussed supra for claim 12) comprising:
a flexible stabilizing mechanism (discussed supra for claim 14);
a deactivation wire (e.g. [0171], suture);
an annuloplasty ring (discussed supra for claim 12) comprising:
a body member (discussed supra for claim 12) having an elongate insertion geometry and an annular operable geometry (discussed supra for claim 12) and comprising a first end and a second end opposite the first end (discussed supra for claim 12), wherein the first end is not engaged to the second end in the elongate insertion geometry and the first end and the second end are engaged in the annular operable geometry (discussed supra for claim 12);
a plurality of anchors housed within the body member in both the elongate insertion geometry and the annular operable geometry (discussed supra for claim 12);
one or more attachment features coupled to the body member (discussed supra for claim 12), wherein each attachment feature comprises two docking posts disposed on opposing sides of the attachment feature (discussed supra for claim 12), each docking post comprising an aperture configured to receive the deactivation wire (discussed supra for claim 12),
wherein each attachment subassembly comprises a docking post anchorage that is disposed between two docking posts (discussed supra for claim 12), the docking post anchorage comprising an aperture (discussed supra for claim 12) configured to attach the stabilizing tool (discussed supra for claim 12).
Regarding Claim 20, the one or more attachment features are integral with the body member (discussed supra for claim 15).
Regarding Claim 22, the deactivation wire extends through the apertures of each docking post of each attachment feature, and wherein the deactivation wire couples to the flexible stabilizing mechanism (e.g. [0171], shown for Figure 12E).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/8/2026