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 .
Restriction/Election
Applicant’s election without traverse of Group III, Claims 21-31 in the reply filed on 11/24/2025 is acknowledged.
Claims 1-20and 32-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/2025.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masoumi et al. (Tri-layered elastomeric scaffolds for engineering heart valve leaflets) (submitted by the applicant) in view of Datta et al. (US20100318108 submitted by the applicant) and further in view of Wagner et al. (US 20120236688).
The claims are drawn to a stable biomimetic biomaterial, comprising
a first layer;
a second layer comprising PCU foam;- and
a third layer, comprising polycarbonate polyurethane (PCU) film embedded with aligned
polycaprolactone (PCL) fibers,
wherein the layers form a composite structure, and
wherein at least one of the first layer and the third layer comprises polycarbonate
polyurethane (PCU) film having embedded aligned polycaprolactone (PCL) fibers therein.
Regarding claim 21, Masoumi teaches a stable tri-layered biomimetic biomaterial for engineering heart valve leaflets comprising a polymeric film embedded with aligned polycaprolactone (PCL) fibers. Masoumi teaches that polymeric layer comprising poly (glycerol sebacate) (PGS) aligned polycaprolactone (PCL) fibers, wherein the layers form a composite structure. See the abstract,. Masoumi does not specifically teach that the said polymer film is polycarbonate polyurethane (PCU) film; and the second layer comprises PCU foam. However, Datta teaches a composite mesh intended for repair of soft tissue defects, comprising a novel biodurable reticulated elastomeric matrix which is designed to support tissue ingrowth and at least one functional element. See para [0002]. Datta teaches the composite implantable device for promoting tissue ingrowth therein is provided, comprising (i) a first biodurable reticulated elastomeric matrix having a three-dimensional porous structure comprising a continuous network of interconnected and intercommunicating open pores, and (ii) a polymeric surgical mesh comprising a plurality of intersecting one-dimensional reinforcement elements. The mesh is affixed to a face of the first matrix. Preferably, the first matrix comprises polycarbonate polyurethane or polycarbonate polyurethane-urea. See Paras [0005], [0048], [0110] and [0148].
It would have been obvious to a person skilled in the art to use polycarbonate polyurethane in the composition of Masoumi, motivated by the teachings of Datta, which teaches the use of polycarbonate polyurethane in a foam and film form in a mesh being used for tissue repair.
Regarding claim 22, Masoumi does not teach wherein the composite structure lacks animal-derived tissues. However Datta teaches the structural materials for the inventive biodurable reticulatd elastomers are synthetic polymers. See Para [0048].
Regarding claim 23, Masoumi and Datta do not teach the biometric biomaterial having a low protein absorption. However, the low protein adsorption is the inherent property of polymers used in the claimed biometric material taught by Masoumi and Datta in the absence of evidence to the contrary.
Regarding claim 24, the low calcium adhesion is the inherent property of biomimetic biomaterial taught by Masoumi and Datta in the absence of evidence to the contrary.
Regarding claim 25, Masoumi teaches a surface layer disposed at least one surface of the composite structure See Fig 1.
Regarding claim 26, Masoumi and Datta do not teach the use of parylene as a surface layer. However, Wagner et al. teach the use of parylene as a coating in a biodegradable polymeric composite for heart valve replacement. See Para [0064].
It would have been obvious to a person skilled in the art to use parylene as a surface coating, motivated by the teachings of Wagner et al, which teach the use of parylene in a biodegradable polymeric composite for heart valve replacement. See Para [0064].
Regarding claim 27, Masoumi teaches these constructs were fabricated by assembling microfabricated
poly(glycerol sebacate) (PGS) and fibrous PGS/poly(-caprolactone) (PCL) electrospun sheets to
develop elastic scaffolds with tunable anisotropic mechanical properties similar to the mechanical
characteristics of the native heart valves. See the abstract.
Regarding claim 28, Masoumi discloses wherein the biomaterial exhibits anisotropic mechanical behavior similar to native human valve leaflets. See the abstract and conclusion.
Regarding claims 29, Masoumi and Datta do not teach the tensile modulus of 4 to 8 MPa at the strain of first direction. However, it would have been obvious for the person skilled in the art to adjust the tensile modulus to be within the specified range, by routine experimentation in the absence of evidence to the contrary.
Regarding claim 30, Masoumi and Datta do not teach the tensile modulus of 1.5 to 2 MPa at a strain in a second direction. However, it would have been obvious for the person skilled in the art to adjust the tensile modulus to be within the specified range, by routine experimentation in the absence of evidence to the contrary.
Regarding claim 31, Masoumi teaches wherein the material is in the form of a heart patch repairing material. See the abstract.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617