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) 1-11 and 31-39 is/are pending. Claim(s) 10-30 and 38-39 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 2/17/2026, with respect to claim objections have been fully considered and are persuasive. The objections of claims 1, 5, and 31 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 2/17/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-5, 8, 31-33, and 36 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments with respect to claim(s) 1-9 and 31-37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s argues that the prior art fails to teach the amended claim language. The Examiner notes this language is taught by newly cited prior art as detailed below in the prior art rejection section.
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) 1-2, 4, 6-9, and 31-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Couetil (US 2010/0152844 A1).
Regarding Claim 1, Couetil teaches an annuloplasty ring for mitral valve remodeling adapted for a valve-in-ring procedure (e.g. Figure 7A, abstract), comprising:
an inner core (e.g. Figure 7A, #8) defining a continuous peripheral shape (e.g. Figure 7A, [0074]) and a suture-permeable tubular interface surrounding the inner core (e.g. Figures 7A-7E), the inner core being a solid contiguous cross-section (e.g. Figure 7D shows such a cross-section; [0074] also indicated an embodiment that is the same as Figure 7A, but without the holes #s 5, which is solid and contiguous in all cross-sections) formed of a semi-rigid remodeling material (e.g. [0075]) that will resist distortion when subjected to the physiological forces imparted thereon by the a mitral valve annulus of an operating human heart (e.g. [0025]), the peripheral shape being generally a D-shape with a substantially straight anterior side diametrically across from a posterior side more rounded than the anterior side with arcuate lateral sides therebetween (e.g. Figure 7A), and the peripheral shape is oriented around a central axis at an intersection of a minor axis across the midpoints of the anterior and posterior sides and a major axis across the lateral sides, the central axis defining up and down directions (there is inherently a central axis), wherein,
the inner core has a substantially constant axial dimension (e.g. [0076], at least the length of segments #s 10, 40) and radially thick and thin regions along discrete segments around the peripheral shape (e.g. Figure 7A) configured to enable different rates of radial bending when an internal dilatory force is introduced within the annuloplasty ring (as the regions have differing thicknesses, they enable the claimed different bending rates as claimed; e.g. [0079], Figure 6 shows #s 20, 30, which correspond to thinner sections) and the thick and the thin regions are positioned to urge the D-shaped peripheral shape to a more circular modified shape more circular than the D-shaped peripheral shape when expanded (the thick and thin regions are spread out around the circumference of the device and thus are able to perform the claimed function due to the relative flexibility/rigidity of the sections of the ring).
Regarding Claim 2, the inner core has a first radially thick region at least along the posterior side relative to the lateral sides (e.g. Figures 7A, 6, section #40).
Regarding Claim 4, the inner core has a second radially thick region along the anterior side relative to the lateral sides (e.g. Figures 7A, 6, section #10).
Regarding Claim 6, the second radially thick region has a plurality of spaced radially outwardly opening notches formed therein (e.g. Figure 7A, holes that face radially outward).
Regarding Claim 7, the peripheral shape is asymmetric across the minor axis (e.g. Figure 7A).
Regarding Claim 8, the peripheral shape is three-dimensional and bows down on one side of the minor axis from the anterior side (e.g. Figure 7A).
Regarding Claim 9, the inner core is a semi-rigid metal selected from the group consisting of nitinol, cobalt-chromium, stainless steel, and a titanium alloy (e.g. [0072]).
Regarding Claim 31, Couetil teaches an annuloplasty ring for mitral valve remodeling adapted for a valve-in-ring procedure (discussed supra for claim 1), comprising:
an inner core (discussed supra for claim 1) defining a continuous peripheral shape (discussed supra for claim 1) and a suture-permeable tubular interface surrounding the inner core (discussed supra for claim 1), the inner core being a solid contiguous cross-section (discussed supra for claim 1) formed of a semi-rigid remodeling material (discussed supra for claim 1) that will resist distortion when subjected to physiological forces imparted thereon by a mitral valve annulus of an operating human heart (discussed supra for claim 1), the peripheral shape being generally a D-shape with a substantially straight anterior side diametrically across from a more rounded posterior side with arcuate lateral sides therebetween (discussed supra for claim 1), and the peripheral shape is oriented around a central axis at an intersection of a minor axis across midpoints of the anterior and the posterior sides and a major axis across the lateral sides, the central axis defining up and down directions (discussed supra for claim 1), wherein,
the inner core has a substantially constant axial dimension around the peripheral shape (discussed supra for claim 1) and radially thick and thin regions along discrete segments around the peripheral shape (discussed supra for claim 1) configured to enable different rates of radial bending when an internal dilatory force is introduced within the annuloplasty ring (discussed supra for claim 1) and wherein and there are tapered boundaries therebetween (e.g. Figure 7A), and wherein the inner core has a first radially thick region along the posterior side relative to the lateral sides (discussed supra for claim 2) and the first radially thick region spans an angular extent that is centered on the minor axis and extends in opposite directions to within at least 20o of an intersection of the major axis and the inner core (e.g. Figure 7A).
Regarding Claim 32, the limitations of claim 32 are discussed supra for claim 2.
Regarding Claim 33, the limitations of claim 33 are discussed supra for claim 4.
Regarding Claim 34, the limitations of claim 34 are discussed supra for claim 6.
Regarding Claim 35, the limitations of claim 35 are discussed supra for claim 7.
Regarding Claim 36, the limitations of claim 36 are discussed supra for claim 8.
Regarding Claim 37, the limitations of claim 37 are discussed supra for claim 9.
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.
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) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Couetil (US 2010/0152844 A1) as discussed supra, alone.
Regarding Claims 3 and 5, Couetil discloses the invention substantially as claimed but fails to teach the first and the second radially thick regions are twice the radial thickness of the lateral sides.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the relative size of the thick and thin regions are such that the first and second thick regions are twice the thin region since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (MPEP 2144.05, B; "In reBoesch, 617 F.2d 272,205 USPQ 215 (CCPA 1980))".
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.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/10/2026
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