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 .
Status of Claims
This office action is responsive to the amendment filed on 12/08/2025. As directed by the amendment: claims 1, 3, 5, 6, 13, 15 and 18 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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, 3, 4, 9, 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bennett et al. (US PG Pub. 2019/0125531), hereinafter Bennett.
Regarding claims 1 and 4, Bennett discloses a prosthetic heart valve (100), illustrated in Figures 10A-10D, comprising an annular frame (200) comprising a plurality of commissure support portions (210); and a plurality of leaflets (910) situated within the frame, each leaflet (910) comprising a body (922) and two opposing commissure tabs (938) arranged on opposite sides of the body, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; wherein each commissure of the prosthetic heart valve comprises an attachment member (810), comprising a fabric material (1000), and including a first portion (814), the first portion extending across and attached directly to a corresponding commissure support portion (210) of the plurality of commissure support portions or to a commissure support element configured to be coupled to the commissure support portion, and a second portion (816) that protrudes radially outward from the first portion and extends radially inward toward a central longitudinal axis of the frame (200); a first commissure tab (1CT) of a first leaflet of the plurality of leaflets arranged adjacent to a first side of the second portion (816) of the attachment member and secured directly to the attachment member; and a second commissure tab (2CT) of a second leaflet of the plurality of leaflets arranged adjacent to an opposite, second side of the second portion (816) of the attachment member and secured directly to the attachment member, wherein the second portion (816) is arranged between, in a lateral direction, the first commissure tab (1CT) and the second commissure tab (2CT), wherein the lateral direction is perpendicular to an axial direction and a radial direction that are relative to the central longitudinal axis, illustrated in Figures 10A-10D and modified figure 10D, below ([0133]; [0134] & [0140] – [0144]).
Regarding claim 3, Bennett discloses the prosthetic heart valve of claim 1, wherein the second portion (816) of the attachment member extends radially outward from a central region of the first portion (814) of the attachment member and includes two overlapping layers (1000), each overlapping layer of the two overlapping layers extending from a different inner end of the first portion, wherein the two overlapping layers (1000) overlap in the lateral direction, illustrated in Figure 10D ([0144] – to clarify, it is stated that frame 800 can be wrapped in fabric 1000, and the fabric 1000 each side surface of second portion 816, thereby comprising two overlapping layers).
Regarding claim 9, Bennett discloses the prosthetic heart valve of claim 1, wherein the second portion (816) of the attachment member extends in the axial direction, along an entire height of each of the first and second commissure tabs (1CT&2CT), illustrated in Figures 10A, 10D and modified figure 10D, above ([0141]).
Regarding claim 10, Bennett discloses the prosthetic heart valve of claim 1, wherein the attachment member (810) is attached directly to the commissure support portion (210), wherein the commissure support portion (210) is a support post of the frame (200), and wherein the attachment member is attached directly to the support post via a suture (700) that extends through the attachment member (810) and around an outer surface of the support post, illustrated in Figures 10A and 10D ([0143]).
Regarding claim 12, Bennett discloses the prosthetic heart valve of claim 1, wherein the attachment member (810) is attached directly to the commissure support portion (210) and wherein the commissure support portion (210) is a commissure window (217) formed by spaced apart axially-extending struts (210) of the frame (200), illustrated in Figures 10A and 10D.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bennett.
Regarding claim 14, Bennett discloses the prosthetic heart valve of claim 1, wherein the attachment member (810) is arranged across and attached directly to a cell (217) of the annular frame, the cell formed by angled struts (210) of the annular frame, via one or more sutures ([0143]); and though it is not specifically disclosed the one or more sutures are extending through the first portion of the attachment member and around the angled struts forming the cell, around a perimeter of the cell, this parameter is deemed to be mere matter of normal design choice, not involving a novel, inventive, step; and it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate way to attach/suture the attachment member to the annular frame, including having the suture extending through the first portion of the attachment member and around the angled struts forming the cell, around a perimeter of the cell.
Allowable Subject Matter
Claims 15-20 are allowed.
Claims 2, 5-8 and 13 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 arguments with respect to independent claim 1 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.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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.
/DINAH BARIA/Primary Examiner, Art Unit 3774 02/24/2026