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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear whether the “resilient wing members” are the same structures as the “resilient wing members” recited in claim 11 or not. The specification does not disclose more than one wing member per outer portion. For the purpose of this examination, the resilient wing members recited in claim 12 are determined to be the same structure as the resilient wing members recited in claim 11.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 depends from cancelled claim 14. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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, 5, 8, 9, 13 and 16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kizuka et al. (US 2018/0133008; hereinafter “Kizuka”; cited by Applicant in parent application 17/163215).
Regarding claim 1, Kizuka discloses a device for repairing a heart valve (Abstract; Figure 9E), comprising: a first clip (10’) comprising an inner portion (12) and an outer portion (14 or 14/20), wherein the inner and outer portions of the first clip are configured to compress tissue of a first heart valve leaflet (“AL”; Figure 9E) therebetween to secure the first clip to the first leaflet; a second clip (10’’) comprising an inner portion (12) and an outer portion (14), wherein the inner and outer portions of the second clip are configured to compress tissue of a second heart valve leaflet (“PL”; Figure 9E) therebetween to secure the second clip to the second leaflet; a post (16) that includes a lumen , wherein the post is coupled to the second clip (each clip has a post - Figure 9E); a tether (86) coupled to at least the first clip (via the post; noting that Applicant’s tether is not fixedly connected to either clip): wherein the tether extends through the lumen of the post (Figure 9E) and wherein the first and second clips are configured to be separately deployable onto the first and second leaflets (evident from Figures 9A and 9B) and secured to one another in vivo by applying tension to the tether to bring the first clip into closer proximity with the post and the second clip (¶[0077]).
Regarding claim 5, the device comprises a locking member (90) configured to engage the tether and thereby secure the first and second clips to one another (¶[0072]).
Regarding claim 8, the device further comprises: a third clip (10’’’; Figure 12) comprising an inner portion (12) and an outer portion (14), wherein the inner and outer portions are configured to compress tissue of a third heart valve leaflet (“Septal leaflet” - Figure 12) therebetween to secure the third clip to the third leaflet; wherein the third clip is configured to be separately deployable onto the third leaflet (as shown for the first and second clips - Figure 9A-9B) and secured to the first and second clips in vivo to bring portions of the third leaflet in closer proximity to the first and second leaflets, thereby improving coaptation of the first, second, and third leaflets (¶[0077], [0079]).
Regarding claim 9, Kizuka discloses a system for repairing a heart valve (Abstract), comprising: an elongate delivery catheter (38) comprising at least one lumen; a heart valve repair device (10’/10’’) coupled to the elongate delivery catheter (Figure 6A), the heart valve repair device comprising: a first clip (10’; Figure 9E) comprising an inner portion (12) and an outer portion (14 or 14/20), wherein the inner and outer portions are configured to compress tissue (“AL”; Figure 9E) of a first heart valve leaflet therebetween to secure the first clip to the first leaflet; a second clip (10’’; Figure 9E) comprising an inner portion (12) and an outer portion (14), wherein the inner and outer portions are configured to compress tissue (“PL”; Figure 9E) of a second heart valve leaflet therebetween to secure the second clip to the second leaflet; a post (16) that includes a lumen, wherein the post is coupled to the second clip; wherein the second clip includes a post defining a lumen (within 82 and/or lumen 24); a tether (86) coupled to at least the first clip (via the post; noting that Applicant’s tether is not fixedly connected to either clip); wherein the tether extends through the lumen of the post (Figure 9E); and wherein the first and second clips are configured to be separately deployable onto the first and second leaflets (evident from Figures 9A and 9B) and secured to one another in vivo by applying tension to the tether to bring the first clip into closer proximity with the post and the second clip (¶[0077]).
Regarding claim 13, the system further comprises a locking member (90) configured to engage the tether and thereby secure the first and second clips to one another (¶[0072]).
Regarding claim 16, the system further comprises: a third clip (10’’’; Figure 12) comprising an inner portion (12) and an outer portion (14), wherein the inner and outer portions are configured to compress tissue of a third heart valve leaflet (“Septal leaflet”; Figure 12) therebetween to secure the third clip to the third leaflet; wherein the third clip is configured to be separately deployable onto the third leaflet (as shown for the first and second clips - Figure 9A-9B) and secured to the first and second clips in vivo to bring portions of the third leaflet in closer proximity to the first and second leaflets, thereby improving coaptation of the first, second, and third leaflets (¶[0077], [0079]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 3, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kizuka in view of Goldfarb et al. (US 2010/0022823; hereinafter “Goldfarb”; cited by Applicant in parent application 15/843995).
Regarding claims 3, 11 and 12, Kizuka discloses that the outer portions of the first and second clips each comprise a frame (14/20) having a wing member (14) but fails to disclose that the wing members are resilient.
Goldfarb teaches that similar wing members (18) can be made of a resilient metal or polymer in order to prevent damage to a leaflet (¶[0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Goldfarb to have made the wing members of Kizuka from a resilient metal or polymer in order to prevent damage to the leaflets.
Response to Arguments
Applicant’s arguments with respect to the pending claims 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.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771