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 . Prosecution is hereby reopened.
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.
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.
Claims 1-4, 8-9, 11-15, 25-27, 29-30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al., US 2004/0138745 A1. Figures 5 and 7 illustrate an implant 500 that includes a flexible unitary frame (paragraphs 0047-0048) shaped to define a loop having a midsection 520 narrowing toward a first bight 540 and a second bight 510 such that first bight 540 is cantilevered at and extends from midsection 520 and over a first mitral leaflet toward an opposing mitral leaflet and back toward midsection 520 to define a leaflet restraining portion (paragraphs 0011, 0048) and second bight 510 extends from midsection 520 and arcs away from the mitral valve against an atrial wall and back toward midsection 520 and the mitral valve so as to define a force distribution portion of implant 500 (paragraph 0048). Implant 500 may be transluminally advanced to the left atrium (paragraphs 0013, 0026, 0044, 0047, 0050, 0063, 0081). Tissue anchors (paragraphs 0047, 0082) generally circumferentially arranged about the mitral annulus would have been obvious in order to more evenly distribute forces and stresses imposed on tissue. Second bight 510 would then extend from a second anchor, arc against an atrial wall, and return back toward a first opposed anchor from which first bight 540 extends.
Regarding claims 2-3, implant 500 is not anchored to or in a ventricle, at least in some embodiments (Figure 7; MPEP § 2125; paragraph 0082, last sentence, implies that ventricular anchoring is optional). Regarding claim 4, implant 500 is advanced to the left atrium while the frame is constrained within a catheter (paragraphs 0047, 0063, 0081). Regarding claims 8, 30, and 32, midsection 520 defines a fulcrum site such that an atrially directed force applied by the first mitral leaflet to first bight 540 is transferred via the fulcrum site to press the force distribution portion of second bight 510 against the atrial wall (pages 5-7: claims 7, 14, 38, 40, 43, 45; Newton’s third law of motion). Regarding claim 12, a sheet 530 is spread over the frame (Figure 5; paragraphs 0011, 0047-0048). Regarding claim 13, implant 500 includes a frame of shape memory for advancement to the mitral valve (paragraphs 0013, 0047, 0050; pages 5-7: claims 3, 10, 18, 22, 26, 29, etc.). Regarding claims 14-15, a support structure adapted for the tissue anchors (paragraphs 0047, 0082) would have been obvious in order to more evenly distribute stresses on the tissue during and after securement of midsection 520. Regarding claims 25-27, perimetral values within the range of 5 cm to 10 cm for the force distribution portion of second bight 510 would have been obvious under routine analysis and/or experimentation in order to accommodate a wide range of sizes among humans and animals and also to avoid interfering with pulmonary veins (paragraphs 0015, 0051-0052). The further limitations of other claims are readily apparent (MPEP § 707) from the referenced drawings and passages in light of the explanations provided above, with the bights corresponding to the lobes of instant claims 29-30.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Thomas Barrett can be reached at telephone number 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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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
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