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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-8, Fig. 4B in the reply filed on 06/18/2026 is acknowledged. Claims 7 and 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claim 7 is directed to non-elected Fig. 4C) and invention, there being no allowable generic or linking claim. Thus, claims 1-6 and 8 are presently pending in this application.
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.
(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 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Neuberger et al. (2023/0028648) “Neuberger”.
Regarding claim 1, Neuberger discloses a prosthetic heart valve (Fig. 1A), comprising: a collapsible and expandable stent 2402 (Fig. 24) having an inflow end 2406 and an outflow end 2418, and a plurality of struts 2412 defining a plurality of cells (as shown in Fig. 24), the stent being formed of a first material (par. 0070 discloses the stent is made of stainless steel); a plurality of commissure attachment features 2426A formed of a second material that is different than the first material of the stent (par. 0100 discloses the commissure attachment features 2426A are formed of Nitinol); and a collapsible and expandable valve assembly including a plurality of leaflets 134 connected to the plurality of commissure attachment features (par. 0066 and par. 0097).
Regarding claims 2 and 3, Neuberger discloses wherein the second material is more flexible than the first material and wherein the second material comprises a second metallic alloy that is different from a first metallic alloy of the stent (par. 0070 discloses the stent is made of stainless steel which is different from the more flexible Nitinol; par. 0100 discloses the commissure attachment features 2426A are formed of Nitinol).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Neuberger et al. (2023/0028648) “Neuberger” in view of Conklin (2012/0078357).
Neuberger discloses the claimed invention of claims 1-2; except for wherein the second material comprises a polymer. However, Conklin teaches a similar heart valve 2700 (Fig. 41) comprising commissure posts 2604 comprising polymer (par. 0196). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second material of the commissure posts in Neuberger to include a polymer, as taught and suggested by Conklin, for providing a biocompatible material that allows flexibility.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Neuberger et al. (2023/0028648) “Neuberger” in view of White (2015/0135506).
Neuberger discloses the claimed invention of claim 1 including comprising at least one connecting strut for coupling each of the plurality of commissure attachment features to the stent (the struts 2412 connected to the commissure attachment features at end 2428; Fig. 24) and wherein the at least one connecting strut comprises two connecting struts arranged in a V-shape (Fig. 24 discloses V-shaped struts 2412) and being connected to an uppermost row of cells disposed adjacent the outflow end 2418 of the stent (Fig. 24 discloses the connecting struts 2412 attached at end 2428 are connected to an uppermost row at the outflow end); except for the at least one connecting strut comprising the second material.
However, White teaches a similar stent (Fig. 6B and par. 0093) comprising connecting struts 2519 comprising a second material (par. 0093 discloses the connecting strut members 2519 have a different more flexible material than struts 2511). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connecting struts in Neuberger to include the at least one connecting strut comprising the second material, as taught and suggested by White, for providing radial flexibility to some struts while maintaining the structural integrity of the stent.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Neuberger et al. (2023/0028648) “Neuberger” in view of White (2015/0135506) further in view of Conklin (2012/0078357).
Neuberger in view of White discloses the claimed invention of claim 5 including the at least one connecting strut is connected to the collapsible and expandable stent (Fig. 24); except for wherein the at least one connecting strut is bonded or welded to the collapsible and expandable stent. However, Conklin teaches a similar stent comprising using welding for attachment (par. 0159). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connecting struts in Neuberger to include the at least one connecting strut is bonded or welded to the collapsible and expandable stent, as taught and suggested by Conklin, for providing secured attachment of the struts during expansion of the stent.
Conclusion
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 (MT).
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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