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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/21/25 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 10/21/25. The claims 1-4, 6, 7, 9, 11-14, 21-24, 26, 28-32 are pending. The claims 1, 2, 6, 7, 9, 23, 24, and 26 are amended. Claims 30-32 are new. Claims 25 and 27 has been cancelled.
Response to Arguments
Applicant’s arguments, filed 10/21/25 with respect to the rejections of claims 1, 2, 7, 9, 11-14, 21-24, and 26-29 under 35 U.S.C. 102(a)(1) as being anticipated by Haivatov (US2018/0206982). Applicant argues, Haivatov does not teach “an entirety of the second seal is located between a distal end and a proximal end of the prosthesis”. Examiner disagrees as addressed in the rejection below.
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 30-32 are 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 pre-AIA the applicant regards as the invention.
Claim 30 recites “a distal end and a proximal end of the prosthesis”. Claim 1 from which claim 30 depends previously recited “a distal end and a proximal end of the prosthesis”. It is unclear if the claims are referring to the same or different structural feature.
Claims 31 and 32 are rejected under 35 U.S.C. 112(b) by dependency.
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, 2, 7, 9, 11-14, 21, 23, 24, 26, and 28-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haivatov (US2018/0206982).
Regarding claim 1, Haivatov discloses a prosthesis (400) comprising a frame (402), a valve (leaflets 410) attached on the frame ([0113]), and at least two seals (416/418), wherein each of the at least two seals project into an interior of the prosthesis (the inflow protection portion 416 and outflow protection portion 418 encapsulate the ends of the struts at the inflow and outflow ends, and therefore project interiorly of the prothesis, [0121], see Fig. 22), and wherein a first seal (416) is attached to an interior of the prosthesis at an inflow region ([0121]) and a second seal (418) is attached to the interior of the prosthesis at an outflow region ([0121]);
wherein an entirety of the second seal is located between a distal end and a proximal end of the prosthesis (see annotated Fig. 20, where the proximal end is interpreted as the proximalmost surface of the prosthesis and the distal end is interpreted as the distalmost surface of the prosthesis, where the entirety of the second seal 418 would be between the distalmost and proximalmost surfaces since the end surface of the second seal 418 would be the distalmost end of the prosthesis, where the prosthesis is claimed as including the seal 418).
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Regarding claim 2, Haivatov discloses the prosthesis of claim 1, wherein:
the frame is a single frame (see Fig. 22).
Regarding claim 7, Haivatov discloses the prosthesis of claim 1, wherein: the first seal is a sealing cover at the inflow region of the prothesis ([0121], see Fig. 22) and the second seal is a sealing cover at the outflow area of the prothesis ([0121], see Fig. 22).
Regarding claim 9, Haivatov discloses the prosthesis according to claim 7, wherein the first seal and the second seal comprise wherein the first seal and the second seal have specific attachment points for attachment to the frame (attachment points are interpreted as where the strip member 424, 436 of 416, 418 is sutured to the strut members, [0123], [0124]).
Regarding claim 11, Haivatov discloses the prosthesis of claim 9, wherein the first seal and the second seal and their attachment points for attachment to the frame are not compromised by elongation difference between a material of the first seal and the second seal and a material of the frame (the material of the seals 416, 418 are made of durable materials that are folded around the frame, [0119], therefore the elongation difference will not compromise the attachment).
Regarding claim 12, Haivatov discloses the prothesis of claim 11, wherein the first seal and the second seal are attached to at least one of attachment points I, E, J, and K of the frame (the attachment points I, E, are interpreted as points along the circumference of the inflow portion of valve, the attachment points J, K are interpreted as points along the circumference of the outflow portion of valve, [0123], [0124]).
Regarding claim 13, Haivatov discloses the prothesis of claim 12, wherein the attachment point I, E, J, or K is positioned to prevent stretching or folding of the first seal and the second seal when the prothesis is in a crimped state (the suture attachment keeps the seals 416, 418 attached to the frame so that the seals prevent stretching or folding, [0123], [0124]).
Regarding claim 14, Haivatov discloses the prothesis of claim 12:
a distance between the attachment points I to K is in the range of 12 to 30 mm, a distance between the attachment points J to K is in the range of 12 to 30 mm, and a distance between the attachment points K to E is in the range of 0 to 15 mm (the length dimension of the strips 424, 426 is 93 mm where the stitching is around the entirety of the circumference of the valve, [0121]).
Regarding claim 21, Haivatov discloses a method of treating a heart valve disease comprising implanting the prosthesis of claim 1 in a subject in need thereof ([0003]).
Regarding claim 23, Haivatov discloses the prosthesis of claim 2, the frame includes the inner frame and the outer frame, wherein the inner frame and outer frames are attached to each other are attached to each other (outer covering 412 is interpreted as the outer frame that is sutured to the frame 402, [0114], see Fig. 22).
Regarding claim 24, Haivatov discloses the prosthesis of claim 23, the frame includes the inner frame and the outer frame, and wherein the inner frame and the outer frame are attached to each other by one or more sutures ([0123]).
Regarding claim 26, Haivatov discloses the prosthesis of claim 7, the valve or the at least two seals are made of biological material, wherein the biological material comprises pericardium tissue (strips 424, 436 which form the seals 416, 418 can be made of pericardium tissue, [0119]).
Regarding claim 28, Haivatov discloses prosthesis of claim 7, where the outflow area of the prosthesis is at a ventricular area (the heart valve is implanted in a heart valve so that the outflow is at a ventricular area, [0160]).
Regarding claim 29, Haivatov discloses the method of claim 21, wherein the heart valve disease is a heart valve insufficiency, a heart valve stenosis, or a regurgitation ([0076]).
Regarding claim 30, Haivatov discloses the prosthesis of claim 1, wherein the prosthesis has a groove (defined by the edge 442 on the exterior surface 432 of the cushioning layer 414, [0118], see Fig. 22) between a distal end and a proximal end of the prosthesis.
Regarding claim 31, Haivatov discloses the prosthesis of claim 30, wherein the frame includes an inner stent (the frame 402 is interpreted as an inner stent by being inside of the covering 412, [0114]), wherein the first seal is an inflow sealing cover (416 is an inflow protective portion, [0115]) configured to push against a cardiac wall or an annulus during systole for directing the blood flow to the inner stent (the portion 416 deforms when contacting native tissue and would therefore be capable of pushing against a cardiac wall or annulus during systole and directing blood through the inner stent 402, [0116]).
Regarding claim 32, Haivatov discloses the prosthesis of claim 31, wherein the second seal is an outflow sealing cover (418 is an outflow protective portion, [[0114]]) configured to push against a cardiac wall or an annulus during diastole (the portion 418 is for the same purpose as the portion 416 and would deform when contacting native tissue and would therefore be capable of pushing against a cardiac wall or annulus during diastole, [0116]).
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 of this title, 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Haivatov (US2018/0206982)
Regarding claim 3, Haivatov the prosthesis of claim 2; yet, does not explicitly disclose wherein the frame comprises a nitinol. Haivatov according to another embodiment discloses the valve comprising nitinol ([0033]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the frame comprise nitinol as taught by another embodiment of Haivatov, since nitinol is a self-expanding material known in the art for use with expandable heart valves ([0033]).
Claims 2, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Haivatov (US2018/0206982) as applied to claims 1 and 3 above, and further in view of Cohen-Tzemach (US2017/0231761) (“Cohen”).
Regarding claim 4, Haivatov the prosthesis of claim 3; yet, does not disclose wherein the frame is a braided mesh. Cohen teaches a heart valve with a frame that can be a braided metal and made of nitinol ([0033], [0035]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted the frame of a braided nitinol mesh for the frame of Haivatov, since the substitution would have the same predictable result of a frame structure for a prosthetic heart valve to be implanted within a native valve.
Regarding claims 2 and 6, Haivatov, under a different interpretation, discloses the prosthesis of claim 1; yet, does not explicitly disclose the frame is composed of an inner frame and an outer frame, wherein the inner and the outer frame comprise a wire nitinol mesh. Cohen teaches a heart valve with an inner frame that can be a braided metal and made of nitinol ([0033], [0035]) and has an outer frame the includes nitinol wires ([0057]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted the frame of a braided nitinol mesh for the frame of Haivatov, since the substitution would have the same predictable result of a frame structure for a prosthetic heart valve to be implanted within a native valve.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Haivatov (US2018/0206982) as appled to claim 1 above, and further in view of Tuval (US2009/0138079).
Regarding claim 22, Haivatov discloses a method for minimally invasive implantation of the prosthesis according to claim 1, and further discloses comprising loading the prosthesis in a delivery system ([0077]); yet does not disclose introducing the delivery system transfemorally in a patient, wherein the prosthesis is deployed at a target site. Tuval teaches a valve prosthesis for implanting within the native valve that includes a support frame and valve ([0074]), where the valve is delivered by the transfemoral procedure ([0075]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have introduced the prosthesis of Haivatov transfemorally, as taught by Tuval, in order to implant the prosthesis by a minimally invasive approach ([0075] of Tuval).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774