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 .
Claims 1,2 and 5-22 are pending. Claims 3 and 4 have been cancelled. Applicant’s election without traverse of claims 1.2 and 5-21 in the reply filed on April 22, 2026 is acknowledged. Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 1,2 and 5-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “long-acting” in claims 1,2 and 5-21 is a relative term which renders the claim indefinite. The term “long-acting” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The examiner is unclear as how to interpret what time period encompasses “long-acting”. For examination purposes the examiner interpreted any anthrombosis property as long-acting.
Claims 5 and 8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 and 8 recite the limitation "methacryloyloxyethyl sulfobetaine" as a phosphocholine compound, but the sulfobetaine is not a phosphocholine.
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.
Claims 1,2,5,6 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Guo (Hydrogel hybrid porcine pericardium for the fabrication of a pre-mounted TAVI valve with improved biocompatibility. J. Mater. Chem B. 2019, 7,1427-1434, Feb 5, 2019) in view of Pathak (WO 2006/026325).
Guo teaches preparing a porcine (animal-derived) pericardium aortic valve by crosslinking with 0.25% glutaraldehyde for 24 hours and 1% glutaraldehyde for 48 hours followed by immersing in a an aqueous of 2-methacryloyloxyethyl phosphorylcholine (synonym for 2-(methacryloyloxy)ethyl-2-(trimethylamine) ethyl phosphate) and 1% methylenebisacrylamide crosslinker and rinsing (page 1428, materials and methods). Gup teaches anti-thrombosis benefits of the treated porcine pericardium (page 1431, right column, platelet adhesion.
Guo does not teach heat treatment after treating with the phosphorylcholine.
Pathak teaches implantable tissues such as porcine pericardium heart valves (paragraph 0097) are effectively crosslinked with N,N-methylenebisacrylamide (paragraph 0127), isocyanate, N-hydroxysuccinimide (paragraph 0107), 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide hydrochloride (paragraph 0227), and crosslinking temperatures are carried out at 0-45°C, preferably about 25 to about 30°C for rapid crosslinking without side reactions (paragraph 0163) for 1 minute to one day or 6 hours at pH level of 6-9 (paragraph 0180). Pathak teaches crosslinking with glutaraldehyde (paragraph 0070) at pH 7.2 for 24-48 hours (paragraph 0090). Pathak teaches adding monomers of 2-methacryloyloxyethyl phosphoryl choline to promote crosslinking (paragraph 00145). Pathak teaches adding polymerization initiators such as methacrylamides, Pathak teaches adding acrylates, methacrylates and methacrylamides as polymerizable groups (paragraph 0107). Pathak teaches using solvents including water, methanol, ethanol and isopropanol (paragraph 0109). Pathak teaches using monomers such as butyl methacrylate (paragraph 00122). Pathak teaches the concentrations, times and temperatures are controlled to control the degree of substitution (paragraph 00110-00113,0119).
It would have been obvious to one of ordinary skill in the art tat the time the invention was made to modify the methods of Guo by selecting the claimed crossllinking agents and concentration, auxiliary monomers and concentration, ratios of crosslinker to modifier, treatment times, temperatures and pH values as Pathak teaches treating similar porcine pericardium heart valves with crosslinkers selected from glutaraldehde, N,N-methylenebisacrylamide, isocyanate, N-hydroxysuccinimide and 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide hydrochloride, modifiers of acrylates, methacrylates such as butyl methacrylate, methacrylamides, 2-methacryloyloxyethyl phosphoryl choline, solvents such as water, methanol, ethanol and isopropanol at treatment temperatures of preferably 25-30°C for treatment times of one minute to one day are effective in crosslinking the valve implants and making them biostable for bioprosthetic heart valves. Pathak emphasizes the concentrations of monomers and crosslinkers, times, pH and temperatures of treatment are selected by one of ordinary skill in the art to control the degree of substitution and crosslinking of the heart valve tissue. Selecting the claimed crosslinkers, modifiers, auxiliary monomers, treatment times, temperatures and pH values would be obvious through routine experimentation to provide an implantable heart valve with a desired degree of crosslinking and substitution of modifiers to ensure biostability and implantation success.
Allowable Subject Matter
Claims 7 and 9-11 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 after correction of the 112 issues. The prior art do not teach or fairly suggest the claimed combinations of crosslinkers and modifiers of claims 7 and 9-11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINA S KHAN whose telephone number is (571)272-5573. The examiner can normally be reached Monday-Friday, 9am-5:30pm EST.
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/AMINA S KHAN/Primary Examiner, Art Unit 1761
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