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 05/22/2026. As directed by the amendment: claims 1, 3, 6-13, 15-16 and 18-21 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1, 3, 6-13, 15-16 and 18-21 have been considered but are moot in view of the new ground(s) of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 7-9 and 16 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not provide adequate written description for “a first bendable second deformable portion situated between the first body portion and the second body portion and across from the first breakable deformable portion” in claims 7 and 16; “wherein the first body portion, the second body portion, the first breakable deformable portion, and the first bendable second deformable portion are configured to form a continuous ring in a generally circular shape” in claim 8; “wherein the first body portion, the second body portion, the first breakable deformable portion, and the first bendable second deformable portion are configured to form a continuous ring having a first generally flat portion” in claim 9. Throughout the disclosure, there is no support for a bendable portion and a breakable portion located across from each other. The specification uses “bendable” and “breakable” interchangeably where the same portion is both bendable and breakable. Therefore, two separate sections where one is bendable and the other is breakable is new matter.
Claim 10 is rejected as being dependent from a rejected base claim 9.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 6-13, 15-16 and 18-21 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Bapat et al. (2021/0369457) “Bapat”.
Regarding claim 1, Bapat discloses a device 10 (Fig. 3) for treating a heart valve (Valve in ring or VIR procedure; par. 0056) comprising: a first body portion; a second body portion, the first body portion and the second body portion together forming an at least partial ring with a gap between the first body portion and the second body portion (Fig. 4 discloses a gap between two portions of wired core 18 of ring 10); a first breakable portion 15 situated within the gap between the first body portion and the second body portion (Fig. 4 and par. 0061) and coupled to the first body portion and the second body portion (Fig. 4 and par. 0061); and a covering 16 at least partially enclosing the first body portion, the second body portion, and the first breakable portion (par. 0061 and Fig. 3 disclose the covering 16 fully encloses the ring 10 including the breakable portion 15); wherein the first body portion, the second body portion, and the first breakable portion are configured to be attached to an annulus portion of the heart valve (par. 0059 and Fig. 18 disclose the ring 10 including the breakable portion 15 attach to a heart valve).
Regarding claim 3, Bapat discloses wherein the first breakable portion is configured to break in response to expansion forces (pars. 0059 and 0061).
Regarding claims 6 and 18, Bapat discloses wherein the first body portion, the second body portion, and the first breakable portion are configured to form a continuous ring (as shown in Fig. 3).
Regarding claims 7-10, as best understood, Bapat discloses a first bendable portion situated between the first body portion and the second body portion and across from the first breakable portion (Fig. 5 and par. 0062 disclose bendable/breakable portions 25 where the polymer section 25 is capable of bending and breaking and one polymer section 25 is across from another polymer section); wherein the first body portion, the second body portion, the first breakable portion, and the first bendable portion are configured to form a continuous ring in a generally circular shape (as shown in Fig. 5); wherein the first body portion, the second body portion, the first breakable portion, and the first bendable portion are configured to form a continuous ring having a first generally flat portion (continuous ring in Fig. 5 comprises a flat anterior portion 12); wherein the first breakable portion is situated at the first generally flat portion (breakable portions 15 and 25 are located at a flat anterior portion 12; Figs. 3 and 5).
Regarding claims 11 and 20, Bapat discloses a third body portion; a second breakable portion situated between the second body portion and the third body portion; and a third breakable portion situated between the first body portion and the third body portion (as shown in Fig. 5, the ring comprises a third body portion located in the posterior portion 14 and breakable regions 25 on the left and right sides of the ring and located between the first, second and third body portions).
Regarding claim 12, Bapat a method for treating a heart valve (Figs. 15-18) comprising: delivering a deformable device to an annulus of the heart valve (par. 0059), the deformable device comprising: a first body portion; a second body portion, the first body portion and the second body portion together forming an at least partial ring with a gap between the first body portion and the second body portion (Fig. 4 discloses a gap between two portions of wired core 18 of ring 10); a first breakable 15 portion situated between the first body portion and the second body portion (Fig. 4 and par. 0061); and a covering 16 at least partially enclosing the first body portion, the second body portion, and the first breakable portion (par. 0061 and Fig. 3 disclose the covering 16 fully encloses the ring 10 including the breakable portion 15); attaching the deformable device to an annulus portion of the heart valve (Figs. 15-18); delivering a subsequent repair device to the heart valve; permanently deforming the deformable device by breaking the first breakable portion to allow attachment of the subsequent repair device at the heart valve; and attaching the subsequent repair device at the heart valve (par. 0059 discloses attaching an artificial valve to the ring 10 after the deformable portion breaks/deforms from a predetermined level of force applied to the ring).
Regarding claims 13 and 15, Bapat discloses wherein the subsequent repair device is a replacement heart valve (artificial valve; par. 0059) and wherein the first breakable portion is configured to break in response to expansion forces from a medical device (pars. 0059 and 0061 disclose the breakable portion 15 can break in response to a predetermined force which is fully capable of performing the intended use of being configured to break in response to expansion forces from a medical device such as an artificial valve).
Regarding claim 16, as best understood, wherein the deformable device further comprises a first bendable portion disposed between the first body portion and the second body portion and across from the first breakable portion (Fig. 5 and par. 0062 disclose bendable/breakable portions 25 where the polymer section 25 is capable of bending and breaking and one polymer section 25 is across from another polymer section); wherein the first bendable portion is configured to bend in response to expansion forces from a medical device (pars. 0059 and 0061 disclose the breakable portion 15 can break in response to a predetermined force which is fully capable of performing the intended use of being configured to break in response to expansion forces from a medical device such as an artificial valve).\
Regarding claim 19, Bapat discloses further comprising a second breakable portion situated between the first body portion and the second body portion and across from the first breakable portion (Fig. 5 and par. 0062 disclose a second breakable portion 25 across from another polymer section).
Regarding claim 21, Bapat discloses wherein the covering 16 fully encloses the first breakable portion to prevent fragments of the first breakable portion from contacting tissue (par. 0061 discloses the covering 16 maintains integrity of the ring which is fully capable of performing the intended use of “to prevent fragments of the first breakable portion from contacting tissue”).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. 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.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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