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 .
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.
Claims 83-97, 101, and 110-115 are rejected under 35 U.S.C. 103 as being unpatentable over Gilmore et al., US 9,801,720 B2, cited in the Information Disclosure Statement of November 14, 2023. Figure 4B shows an implant or tether 22 with alternating patterns defined by knots 170 (column 27, lines 34-64), the crosshatched lines at different angles apparently depicting the warp and woof of a knitted fabric, and such a fabric would have been obvious to one of ordinary skill in the art at the effective filing date of the present invention in order to lessen stress concentrations near and along knots 170 (column 1, lines 57-61; column 5, lines 6-7; column 6, lines 1-2 and 25-28; column 44, lines 1-15), to support shear and torsional stresses (column 2, lines 1-3; column 3, lines 8-10; column 4, lines 54-55; column 34, lines 21-26), and to facilitate incorporation of electrically conductive and/or radiopaque wires or fibers (column 12, lines 49-50; column 17, lines 1-2; column 36, line 65, to column 37, line 2; column 46, lines 25-35). Each knot 170 would thus be an instance of a first fabric alternating with instances of an integrally attached second fabric disposed between successive knots 170, with a continuum of angles for first, second, third, and fourth fibers including respective orientations of 45°, 135°, 0°, and 90° relative to a longitudinal axis of tether 22 (MPEP § 2125), and the body portion or tether 22 so formed is configured to be secured along tissue of the heart such that the longitudinal axis lies along the tissue with the alternating pattern alternating along the tissue (Figures 5B-5D, 6C-6E, 8-9, 16A-16C; abstract; column 5, lines 1-7; column 29, line 47, et seq.; column 43, lines 59-61; column 44, lines 11-15; etc.).
Regarding claims 84-88, the second fabric is configured to be attached to tissue via a helical screw anchor (Figures 1A-1F, 2A-2B, 3A-3E, 6A, 6C, 8, 12A-12C, 13A-13B, 14A-14B, 15, 22, 23A-23B, 24A-24C; abstract; column 3, lines 43-46 and 57-62; column 24, line 4, et seq.; column 37, lines 9-19; column 39, lines 41-67); because of the sharpened distal end (drawings; column 24, lines 7-9), the helical screw anchor is structurally capable of being driven through the second fabric (instant claim 87; MPEP § 2114), whether or not such was the intended use. The further limitations of claims 89-97 are addressed above (MPEP § 707). Regarding claim 101, polyethylene terephthalate (PET) was well-known in the art at the effective filing date of the present application and would have been obvious from its advantageous properties as to strength, biocompatibility, and so on, with the ordinary practitioner having been left to select a suitable material for the “polymer” or “polymer/metal composite” (e.g., column 12, lines 48-50). Regarding claims 110-111, “first” and “second” instances of fabric are somewhat arbitrary with respect to the limitations of present claim 83; knots 170 have greater strength and lesser lateral compressibility because of their enhanced thickness and tightened state in comparison to the intervening instances (with “first” and “second” being interchanged relative to the discussions above). Regarding claim 112, body portion or tether 22 is physically capable of being secured along a heart valve annulus such that a longitudinal axis of tether 22 lies with the pattern alternating along the annulus, even though such was not the purpose of the implant (MPEP § 2114). Regarding claim 113, the Gilmore et al. system and method additionally comprise tools for securing tether 22 along heart tissue (Figures 5A-5D, 6A-6E, 7, 9; column 1, lines 64-67; column 3, lines 4-14; column 5, line 18, et seq.; column 28, line 43, et seq.). Regarding claims 114 and 115, tensioning a flexible elongate member such as the aforementioned electrically conductive or radiopaque wire or fiber (column 46, lines 25-35) straightens and lengthens body portion 22 by virtue of the innate stress-strain characteristic or elastic modulus of the wire or fiber material.
Allowable Subject Matter
Claims 98 and 107-109 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.
Response to Arguments
Applicant’s remarks have been considered but are deemed moot in view of the new grounds of rejection, necessitated by the new claims and by the language added to claim 83.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL (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 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