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 .
Specification
The disclosure is objected to because of the following informalities: In specification paragraph 0064, first line, “111c” should be --211c--; on the second line, “11d” should be --211d--. On page 13, eighteenth line, “couple” should read --coupled--. In paragraph 0078, second line, Applicant may want to delete the first occurrence of “valve”. In paragraph 0080, fourth line, “325a” should be --320a--; on the ninth line, “335” should be --335a--. In paragraph 00115, third line, “is it” should be --it is--. 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.
Claims 1-4, 9-10, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Oba et al., US 2016/0310268 A1, which discloses an outer frame connected to an inner frame coupled with a plurality of leaflets functioning similar to a natural heart valve (Figures 7, 12-13, 24-25; paragraphs 0013-0014, 0024, 0062, 0107) and a sealing feature 330 extending radially outwardly in a direction substantially orthogonal to a longitudinal axis of the inner frame, coupled to points on the inner and outer frames, and comprising a plurality of layers (Figures 7, 9, 14-17, 24-25; paragraphs 0109-0115). Regarding claims 2-4, sealing feature 330 may involve angular offsets of weave patterns in first and second layers (Figure 16; paragraph 0113). Regarding claims 9-10 and 12, overlapping and non-overlapping regions are formed by the flexible material 336 circumscribing orifice 332 and by struts 340 (Figures 14-15; paragraphs 0111-0112). Regarding claims 13-14, the layers are coupled to outer frame 308 (paragraph 0110) and are innately coupled to each other in order to maintain beneficial angular orientations (paragraphs 0111, 0113) and the like.
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 5-8, 11, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Oba et al., US 2016/0310268 A1. Regarding claim 5, indicia such as notch alignment would have been obvious in order to facilitate manufacture such that proper fiber orientations for increasing “the ability of the sealing member to resist enlargement of the orifice 332” (paragraph 0113, last sentence) are attained. Regarding claims 6 and 8, angular offsets of 45° for two stacked layers would have been obvious to one of ordinary skill in the art at the effective filing date of the instant invention so as to more evenly and symmetrically provide reinforcement for orifice 332 (paragraph 0113). Regarding claim 7, sealing feature 330 layers are substantially impermeable to blood flowing through a respective layer (paragraphs 0084, 0109-0110). Regarding claims 11 and 16-17, a second or non-overlapping region positioned radially inwardly relative to an overlap region would have been an obvious variant in order to provide thickened reinforcement (in inflow and/or outflow directions) for the suturing or attachment to frame 308 (paragraph 0110). Regarding claim 15, a double running stitch pattern would have been obvious from the seams or stitching 348 (Figure 17; paragraph 0114) in order to provide a durable sealing feature 330 (paragraphs 0109-0110).
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 Melanie Tyson can be reached at telephone number 571-272-9062. 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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