ANNULOPLASTY SYSTEMS AND METHODS

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) 1-21 is/are pending. Allowable Subject Matter Claims 6-16 and 18-21 are 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. Claims 1-21 are allowable over the prior art, but are otherwise rejected as noted below. The prior art lacks a teaching of a delivery method of a first member and a second member (having first and second tensile member attachment points), as claimed, where the method includes maneuvering the first tensile member attachment point and the second tensile member attachment point into an anchoring position concurrently, in addition to the remaining claimed method steps. 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. 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 USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claim(s) see Table I below rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) see Table I below of U.S. Patent No. see Table I below. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table. Table I Current Application Prior Patent US 12,133,800 1-2 14 Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1, 3-5, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1, 3-5, and 17 each recite “it”. It is unclear what element is being referred back to. Examiner suggests replacing “it” with the names of the features being referred back to. Claim 17 recites “a mitral valve annulus”. It is unclear if this is the same or different than the mitral valve annulus introduced earlier in claim 1. For purposes of examination the Examiner considers this language to be “the mitral valve annulus”. Relevant Prior Art US 2013/0190863 A1 to Call, et al teaches a method of mitral valve repair using multiple members connected to one another via tensile members and that are drawn together to repair the function of the mitral valve (e.g. abstract, Figures 17A-D, [0051]). Call lacks maneuvering the first tensile member attachment point and the second tensile member attachment point into an anchoring position concurrently. US 5,593,424 to Northrup III teaches an annuloplasty method of deploying, connecting, and tensioning multiple anchors around a mitral valve annulus. US 2006/0020336 A1 to Liddicoat teaches an annuloplasty method of deploying, connecting, and tensioning multiple anchors around a mitral valve annulus and connecting anchoring members across a mitral valve opening. Liddicoat teaches connecting multiple individual anchors on one side of the mitral valve to the same anchor placed adjacent an aortic valve. US 2008/0228267 A1 to Spence, et al teaches a method of mitral valve repair using multiple members connected to one another via tensile members and that are drawn together to repair the function of the mitral valve (e.g. abstract, Figure 17). US 2011/0166649 A1 to Gross, et al teaches an annuloplasty method of deploying, connecting, and tensioning multiple rotatable anchors around a mitral valve annulus. US 2016/0317302 to Madjarov, et al, teaches an annulus re-shaping implant (e.g. Figures 4, 11C), where each support member 105 supports a corresponding leaflet and the connecting member(s) 110 is a single member or multiple members joined at actuators 115. Madjarov teaches a second member having first and second attachment points (e.g. annotated Figure 4) for attaching tensile members (e.g. [0039], [0044]). Madjarov is silent as to when 110(s) are connected to 115s. Therefore, Madjarov does not meet the amended language of "maneuvering the first tensile member attachment point and the second tensile member attachment point into an anchoring position concurrently" because Madjarov is silent as to when the connections between parts is made. PNG media_image1.png 620 567 media_image1.png Greyscale Annotated Figure 4, Madjarov Conclusion 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, JERRAH EDWARDS can be reached at (408)918-7557. 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 9/28/2026