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 .
Response to Amendment
Applicant’s election of Group I in the reply filed on October 5, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The requirement is still deemed proper and therefore made FINAL.
Claims 1-17 are pending of which claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pending claims 1-8 have been examined on the merits.
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 1-8 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.
In claims 1 (at line 5), 6 (at lines 2-4), and 7 (at lines 2-3), the claims recite the term/abbreviation “GDF 11”. Although the term “growth differentiation factor 11” is known by the abbreviation GDF-11 (and by the alternate equivalent name bone morphogenetic protein 11 (BMP-11)), it is unclear if this is the intended meaning by Applicant of if another interpretation is intended, based on the current record.
In claim 4 the claim recites a concentration of “1.2 mg/ml” (at line 2); however, it is unclear which among the if the mixed solution of copper chloride-dopamine-HCl or the Tris-HCl solution (or component(s) thereof, is/are intended as having the claimed concentration.
In claim 8, the claim recites (at line 3) “a rinsing process”, however it is unclear if the rinsing of step 12, and/or step 22, and/or another rinsing step is intended thereby.
Clarification is required.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
CN 114634763 A – considered the closest art, teaching preparing a crosslinked material with protein coating comprising mixing a material with a dopamine solution to obtain a modified material, mixing the modified material with a modified solution, and mixing with crosslinking solution agent. The reference also teaches the material to be modified and the dopamine solution “is mixed to immerse the material to be modified in the dopamine solution, and reacted 2-72 hours, whereby the concentration of the dopamine solution is 0.01-100 mg/mL, the pH value of the dopamine solution is 8-9, the solvent of the dopamine solution is 0.01-100 mg/mL Tris buffer, and comprising a volume of a soluble copper salt optionally copper chloride, and protein solution, with a cross-linking agent solution.
WO 2016023494 A1 – teaches method of providing a nitric oxide (NO) catalytic adhesive coating, via dip-coating, and which can be applied to a material, optionally an acellular or decellularized porcine heart valve. The process comprises providing dopamine, cysteamine, and a copper salt (sulfate, halide/chloride, etc), dissolving in a pH 5-12 TRIS buffer solution to obtain a mixed solution having a concentration of 1 mg/mL, and then immersing the materials/tissue in the mixed reaction solution, at room temperature, and for 1-48 hours.
WO 2025208090 A1 – teaches methods of preparing an engineered heart valve, including a decellularized and recellularized porcine pulmonary valves.
Qiao S, et al (“Crosslinking Strategies of Decellularized Extracellular Matrix in Tissue Regeneration” J. Biomed. Mater. Res., Part A,(2024),112(5),pp. 640-671; doi:10.1002/jbm.a.37650) – teaches commonly used crosslinking methods with decellularized extracellular matrix (dECM) materials, potential applications, and sourcing from a variety of tissues including from skin, cardiac tissues (pericardium, heart valves, myocardial tissue), blood vessels, liver, and kidney, and modified with different chemical crosslinking reagents.
Wagers, Amy ("Aging and GDF11: What we know" Harvard Stem Cell Institute (HSCI), retrieved from URL: <www.hsci.harvard.edu/aging-and-gdf11-what-we-know>, 3 pages, 2026.) – considered relevant to the state of the art in general, teaching of a GDF-11 protein’s physiological effects, in general.
However the claims are distinguished over the references in that the references do not teach or reasonably suggest further contacting with GDF-11/BMP-11/growth differentiation factor 11/bone morphogenetic protein 11 in a decellularized heart valve (DHV)-composite making process, as instantly claimed.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655