DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group 2, claims 12-17 in the reply filed on 5/26/2026 is acknowledged. Further, it is noted that claims 3-11 and 20-24 are read on the elected group with claims 12-17. Claims 1-2, 18-19 are now cancelled by the applicant.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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(s) 4,6,9,11-16, 20, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe et al U.S 2006/0287717 in view of Schweich et al WO 2013/158613.
Claim 12: Rowe et al disclose a prosthetic heart valve as best seen in fig. 2 comprising: an annular frame 20/70 configured to be radially compressible and expandable between a radially compressed state and a radially expanded state; a valvular structure (it is noted that 3 leaflets 36 are part of the valvular function, see paragraph 64) disposed within the annular frame and configured to regulate flow of blood through the annular frame in portions; and a sealing member (it is noted that a cover 75 is equivalent as a sealing part, fig. 8, see paragraphs 61,79) comprising a fabric substrate, but is silent as a hydrogel structure attached to the fabric substrate that comprising a stimulus-responsive hydrogel and having an exposed outer surface configured to seal against tissue surrounding the prosthetic heart valve when implanted in a patient's body. Schweich et al, in the same field of endeavor, teach the heart valve a mitral valve replacement system according to the present disclosure includes an anchor element, a sealing element, and a valve element, and utilizes an anchor delivery
system, and a valve delivery system. More than one element may be incorporated into a structure, for example, an anchor element also may comprise a sealing structure, or a valve element may comprise a sealing structure (see paragraph 22); and further teach a hydrogel structure attached to the fabric substrate that comprising a stimulus-responsive hydrogel and having an exposed outer surface configured to seal against tissue surrounding the prosthetic heart valve (figures 100, 102, paragraphs 250, 253). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Rowe et al with the sealing member that is hydrogel structure attached to the fabric substrate that comprising a stimulus-responsive hydrogel and having an exposed outer surface configured to seal against tissue surrounding the prosthetic heart valve in order to accomplish securing the implantation with sealing efficiently.
Claims 13, 6: Rowe et al disclose wherein the sealing member comprises: an outer skirt (the outer surface of stent 60) that extends around an outer surface of the annular frame; or an inner skirt (the inner stent 62, fig. 7) that extends along an inner surface of the annular frame (see paragraph 74); further disclose the structure including an annular ring 32, fig. 2.
Claims 14, 15, 20: Schweich et al teach wherein the stimulus- responsive hydrogel undergoes a change in volume, stiffness, or both induced by a stimulus, the stimulus comprising a temperature change, a pH change, an ionic strength change, a solvent composition change, application of an electric field, application of a magnetic field, application of ultrasound, exposure to light, or any combination thereof (see paragraphs 11, 278) , wherein: (i) the hydrogel structure is bonded to the fabric substrate (fig. 83, 84, fabric cover at 510); or (ii) the fabric substrate comprises polyethylene terephthalate or polyethylene; or (iii) the fabric substrate comprises a woven, braided, or knitted fabric; or (iv) any combination of (i), (ii), and (iii) (see paragraph 250); wherein the hydrogel structure comprises a plurality of spaced-apart (the elements 510 are spaced apart) axially extending hydrogel structures having a length L2 less than the length L of the substrate as best seen in figures 83,84.
Claims 11, 16: Rowe et al in view of Schweich et al disclose the invention substantially as claimed, but is silent regarding wherein: (i) the substrate material comprises polyethylene terephthalate or polyethylene; or (ii) the substrate comprises a woven, braided, or knitted fabric; or (iii) both (i) and (ii); herein the stimulus-
responsive hydrogel comprises a natural or synthetic hydrogel, particularly wherein the natural or synthetic hydrogel comprises a poloxamer, a poly(N-
alkylacrylamide), a poly(n-vinylcaprolactam), a poly(alkyloxazoline), a poly(vinyl alkyl ether), a poly(alkyl glycidyl ether), a poly(methacrylic acid), a poly(alkylmethacrylate), a poly(acrylic acid), a poly(vinylpyridine), a poly(vinylimidazole), a poly(thiophene), a poly(alkyloxazoline),a polyamine, a sulfonated polystyrene, ethylene-vinyl acetate, polyurethane, poly(ethylene oxide) (PEO), poly(propylene oxide) (PPO), a polyketal, a polyacetal, a polylactide, a polyglycolide, a polysaccharide, collagen, a peptide, cyclodextrin, a nitrocatechol-terminated. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device with the substrate material comprises polyethylene terephthalate or polyethylene; or (ii) the substrate comprises a woven, braided, or knitted fabric; or (iii) both (i) and (ii); herein the stimulus- responsive hydrogel comprises a natural or synthetic hydrogel, particularly wherein the natural or synthetic hydrogel comprises a poloxamer, a poly(N-
alkylacrylamide), a poly(n-vinylcaprolactam), a poly(alkyloxazoline), a poly(vinyl alkyl ether), a poly(alkyl glycidyl ether), a poly(methacrylic acid), a poly(alkylmethacrylate), a poly(acrylic acid), a poly(vinylpyridine), a poly(vinylimidazole), a poly(thiophene), a poly(alkyloxazoline),a polyamine, a sulfonated polystyrene, ethylene-vinyl acetate, polyurethane, poly(ethylene oxide) (PEO), poly(propylene oxide) (PPO), a polyketal, a polyacetal, a polylactide, a polyglycolide, a polysaccharide, collagen, a peptide, cyclodextrin, a nitrocatechol-terminated, since it has been held to be within the general skill of a worker in the art to select a known material on the basic of its suitability for the intended use or as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 23: Rowe et al in view of Schweich et al disclose the invention substantially as claimed, but is silent regarding wherein the at least one annular
ring has a zig zag configuration. It would have been to one ordinary skill in the art at the time the invention was made to construct the device with the at least one annular
ring has a zig zag configuration, since the applicant has not disclosed that doing so solves any stated problem or is anything more than selecting one of numerous shapes or configurations a person ordinary skill in the art would find available to substitute with the device that has one annular ring with a zig zag configuration that is known in the surgical arts.
Claim 22: Rowe et al in view of Schweich et al disclose the invention substantially as claimed, but is silent regarding wherein the hydrogel structure
tapers from the base width WB to the top width WT at an angle a of 0 degrees to 20 degrees. It would have been obvious to one having ordinary skill in the art before the claimed invention to modify Rowe et al in view of Schweich by making the hydrogel structure tapers from the base width WB to the top width WT at an angle a of 0 degrees to 20 degrees, since it has been held that where the only difference between the prior arts and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device , the claimed device was not patentably distinct from the prior art device” Gardner v. Tec Syst., Inc., 725 F. 2d 1338, 220 USPQ 777 (Fed. Cir . 1984). In the instant case it appears there has been no critically placed on the specific width of the hydrogel structure, as evidence in applicant’s specification at paragraph 94, wherein the ranges and values are given with no preference to one over another nor any evidence of unexpected results.
Allowable Subject Matter
Claims 3,5,7,8,10,17,21,24 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.
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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