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) 1-4, 6-14, and 17 is/are pending. Claim(s) 5 and 15-16 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 12/22/2025, with respect to the claim objection have been fully considered and are persuasive, except that at #8 in the 10/1/2025 Office action. The claim objections of claims 1, 5-8, and 14, except that at #8 in the 10/1/2025 Office action, has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 12/22/2025, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 8-10 has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Applicant argues location A’s taper in annotated Figure 12(1) is not at a commissure section (Applicant’s Response on 12/22/2025, herein “Response”, page 8). Examiner agrees. Location A is part of the first anterior portion as shown in annotated Figure 12(1) below.
Applicant argues the commissure sections and posterior bow portions have the same cross sections (Response, page 8). The Examiner agrees that these sections/portions share some cross-sections having the same shape. However, not all cross sections have the same shape as noted in the prior art rejection section below. The claims require a cross-section within the portion(s)/section(s) as claimed, but do not specify any particular location in the section or cross-section in the portion/section. Thus, Examiner’s locations as noted meet the claimed requirements.
Applicant argues Roberts is missing features Oritz was used to reject. Thus, this argument is moot as it is drawn to a rejection not made.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “the first and second”, which should be “the first and the second”.
Appropriate correction is required.
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) 1-11, 13-14, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oritz, et al (Oritz) (US 6,419,696 B1).
Regarding Claim 1, Oritz teaches an annuloplasty device (e.g. Figure 12, abstract) comprising
first and second support rings (e.g. Figure 12, top ring is the first and bottom ring is the second) having a coiled configuration (e.g. Figure 12) in which the first and [the] second support rings are arranged as a coil around a central axis (e.g. Figure 12),
wherein the first and [the] second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve (e.g. column 1, line 60 to column 2, line 9), and
wherein the first support ring and/or the second support ring comprises a plurality of sides forming a non-circular cross-section of the first support ring and/or the second support ring (e.g. Figures 12-13, rectangular), wherein the cross-section varies along a longitudinal direction of the first and/or the second support ring (e.g. Figures 12-13, at locations where the cross-section changes); wherein:
the first support ring comprises a first posterior bow and a first anterior portion (e.g. annotated Figure 12(1) below),
the second support ring comprises a second posterior bow and a second anterior portion (e.g. annotated Figure 12(1) below),
the first and the second posterior bows are adapted to conform to a posterior aspect of said heart valve (e.g. Figure 12, the posterior bows are shaped to match the curved portion of a D-shaped valve, which is the posterior portion of such a heart valve), and
the first and the second anterior portions are adapted to conform to an anterior aspect of said heart valve (e.g. Figure 12, the anterior portions are shaped to match the straight portion of a D-shaped valve, which is the anterior portion of such a heart valve),
the first posterior bow transitions to the first anterior portion over a first commissure section, the first anterior portion transitions to the second posterior bow over a second commissure section, and the second posterior bow transitions to the second anterior portion over a third commissure section (e.g. Figure 12, as the device is D-shaped it is configured for the claimed transitions; see also Figures 14-16, which show a D-shaped ring implanted in a D-shaped valve),
wherein any of the first, the second, and the third commissure sections have a cross-section which has an area and/or shape which is different than an area and/or shape of the cross-section of the first posterior bow and/or the second posterior bow (e.g. annotated Figure 12(1) below, the commissure sections are at the dotted line where bow portions and anterior portions transition to the respective adjacent section; the area and shape of the cross-section at location E is different than that at locations A and D).
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Annotated Figure 12(1), Oritz
Regarding Claim 2, the cross-section is essentially rectangular (e.g. Figures 12-13).
Regarding Claim 3, the area of the cross-section varies along the longitudinal direction (e.g. Figures 12-13, at locations where the cross-section changes).
Regarding Claim 4, the shape of the cross-section varies along the longitudinal direction (e.g. Figures 12-13, at locations where the cross-section changes).
Regarding Claim 6, any of the first, the second and the third commissure sections have a cross-section which has an area and/or shape which is different than an area and/or shape of the cross-section of the first anterior portion and/or the second anterior portion (e.g. annotated Figure 12(1) above, the cross-sections at any of the commissure sections, represented by location E, differs from that at location A).
Regarding Claim 7, any of the first, the second and the third commissure sections have a cross-section which has an area which is less than an area of the cross-section of any of the first posterior bow, the second posterior bow, the first anterior portion, and the second anterior portion (e.g. annotated Figure 12(1) above, the cross-sectional areas at any of the commissure sections, represented by location E, is less than the cross-sectional area at the posterior bow where #92 is located, including the shape of #92).
Regarding Claim 8, the first and/or the second anterior portion has a cross-section which has an area and/or shape which is different than an area and/or shape of the cross-section of the first and/or second posterior bow (e.g. annotated Figure 12(1) above, where the cross-sectional shape and areas of both the first and the second anterior portions differs from the first and second posterior bows (location A versus location B and location C versus location D)).
Regarding Claim 9, the first anterior portion has a cross-section which has an area and/or shape which is different than an area and/or shape of the cross-section of the second anterior portion (e.g. annotated Figure 12(1) above, the cross-section at location A differs from that at location C).
Regarding Claim 10, the first posterior bow has a cross-section which has an area and/or shape which is different than an area and/or shape of the cross-section of the second posterior bow (e.g. annotated Figure 12(1) above, the cross-section at location B differs from that at location D).
Regarding Claim 11, the cross-section is elongated in a direction extending essentially in parallel with the central axis (e.g. annotated Figure 12(1) above, the cross-sections at locations B, C, and D are each elongated relative to that at location A).
Regarding Claim 13, the first support ring has a cross-section which has an area and/or shape which is different than an area and/or shape of the cross-section of the second support ring (e.g. annotated Figure 12(1) above, the cross-section at location A differs from that at location B).
Regarding Claim 14, the first and the second support rings are formed from a shape-memory material (e.g. abstract), wherein the first and the second support rings have an elongated delivery configuration for advancement in a catheter (e.g. column 3, lines 5-20).
Regarding Claim 17, any of the first, the second, and the third commissure sections have a cross-section which has an area which is less than an area of the cross-section of the first posterior bow, the second posterior bow, the first anterior portion, and the second anterior portion (e.g. annotated Figure 12(1) above, location E versus location A; the cross-section’s surface area at each location differs from that at the other location).
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.
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.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oritz, et al (Oritz) (US 6,419,696 B1) as discussed supra and further in view of Roberts (US 2008/0086203 A1).
Regarding Claim 12, Oritz discloses the invention substantially as claimed but fails to teach the cross-section is rectangular so that the longest sides of the rectangular shape extend essentially in parallel with the central axis.
Roberts teaches an annuloplasty ring having a rectangular cross-section where the rectangular shape extend essentially in parallel with the central axis (e.g. Figures 1-3).
Roberts and Oritz are concerned with the same field of endeavor as the claimed invention, namely annuloplasty rings having rectangular cross-sections.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oritz such that the rectangular shape extend essentially in parallel with the central axis as taught by Roberts as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of an annuloplasty ring having a known (per Roberts) shape.
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.
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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.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 3/16/2026