DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s remarks with respect to claim(s) 165-168, 171-173, 176-180 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.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 165-168, 173 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gross et al. 2014/0324164.
Gross et al. discloses the invention as claimed comprising: A prosthetic heart valve device for implantation at a native heart valve, the prosthetic heart valve device comprising: a frame; a prosthetic valve coupled to the frame (see [0406 and 0572] which discloses a prosthetic valve 1120 and a wire frame); and a sealing member (this is considered to be cover 1128) attached to a surface of the frame. Gross et al. discloses that the material that is placed on the outer surface of the prosthetic valve may be a material such a PET).
wherein the sealing member includes tissue engaging elements comprising metallic or polymeric wires or fibers that are sufficiently rigid and shaped to penetrate tissue at the native heart valve, wherein the metallic or polymeric wires or fibers are woven into material of the sealing member.
It is obvious to one having ordinary skill in the art that PET is a polyester and it is further obvious that polyester materials are woven fabrics thus may be interpreted as the tissue engaging elements as claimed and are capable of performing the functions as claimed.
5. Regarding claim 166, see fig. 31and [0162] which describes that the prosthetic heart valve frame comprises an outer anchoring member (e.g. support 22) and an inner valve support (150), wherein the prosthetic valve is coupled within the inner valve support this may be check valve elements as disclosed).
6. Regarding claims 167 and 173, see figures 31 and [0125] and cover 64. The intended use recitation language “is configured to engage with tissue of the native heart valve and is configured to deform to absorb forces from the native heart valve such that the inner valve support remains sufficiently stable such that the prosthetic valve remains competent when the outer anchoring member is deformed” carries no weight in the absence of any distinguishing structure. Gross et al. discloses the structure as claimed and is thus capable of performing the functions.
Allowable Subject Matter
7. Claims 171-172 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.
8. Claims 176-180 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 February 17, 2026
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