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 .
Election/Restrictions
Applicant's election without traverse of invention group II, drawn to an extracellular matrix comprising collagen, actinin and actin-binding-like protein (filamin-C), claims 11-17 and 19-20, in the reply filed on 5/26/2026 is acknowledged.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/invention.
Claim status
Claims 1-17, 19-20 are pending
Claims 18 and 21-23 are cancelled.
Claims 11- 17, 19,20 are under examination.
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 11-17 and 19-20are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. Claims 12-17 and 19-20 are rejected because they are dependent on the indefinite claim 11, rendering them indefinite for carrying the same limitations in claim 11.
Claim 11 recites filamin-C inside parenthesis. It is not clear if the claim broadly encompasses an actin-binding-like protein with filamin-c exemplary, or filamin-c is an actual limitation in the claim because it is recited within parenthesis. Therefore, the claim is indefinite.
Claim 14 has insufficient antecedent basis, claim recites “the culture medium” and a culture medium was not previously recited. Therefore, it is not clear what medium is referred to by the claim language as written. Therefore, the claim is indefinite.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 11-17,19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US2020/0109367 A1 Block et al., 2020 and Shih, Stem cells 24.11 (2006), as evidenced by Arnhold, et al. Stem cells international (Year: 2017).
Regarding claim 11, Block teaches a cell-derived extracellular matrix (ECM) (example 2, page 10), comprising collagen, actinin, and filamin-C (table 2, page 11), including type I collagen (COL1A1) (table 2, page 13).
Block does not teach ECM proteins being present in the form of entangled nanofibers.
However, ECM components present in entangled nanofiber form was known in the art prior to the effective filling date of the claimed invention.
Shih teaches a scaffold that mimics native ECM, comprising reconstituted type I collagen nanofibers, prepared by an electrospin process (Materials and methods, reconstitution and fabrication of Type I collagen nanofibers, page 2392)that support 3D cell culture (abstract, introduction, pages 2391-2392). Scanning electron micrographs show collagen nanofibers appearing in an entangled form (fig.1, page 2393).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to combine the above-mentioned teachings of Block and Shih to develop an ECM comprising collagen, actinin and filamin-C being present in the form of entangled nanofibers. One of ordinary skill in the art would have been motivated to modify the teachings of Block to include the reconstituted type I collagen nanofibers of Shih, prepared by electrospin process, in order to facilitate the entangled nanofiber form in the ECM which mimics native ECM that support 3D cell culture. There would be a reasonable expectation of success to combine the teachings of Block and Shih, because the cell-derived ECM of Block also contain Type I collagen.
Regarding claim 12, shih teaches collagen nanofibers of 200-500 nm (figure 1, page 2393).
Regarding claim 13, This claim has conditional language, reciting that extracellular matrix (ECM) has elasticity and compliance when including cells, and no elasticity and compliance when not including the cells. This is not further limiting the structure of the claimed ECM, because the cells are not a requirement in the ECM composition. Therefore, the combined teachings of Block and Shih teach the requisite structure.
Regarding claim 14, This claim has conditional language, requiring culture medium which is not a required component in the claimed ECM as recited in claim 11. Therefore, this claim does not further limit the structure/composition of the claimed ECM. However, shih teaches culturing cells on collagen nanofibers with culture media (material and methods, cell seeding and in vitro differentiation, page 2392), indicating that culture media is movable between the entangled nanofibers. The nanofibrous structure taught by Shih contain pores (Results, characterization of type I collagen nanofibers, page 2394), that may facilitate the movement of media. Therefore, the combined teachings of Block and Shih teach the requisite structure.
Regarding claim 15, Block teaches the ECM comprising COL1A1, COL1A2, COL3A1, COL5A2, CAV1 and THY1.
Regarding claim 16, Block teaches a cell-derived ECM, produced in-vitro via cells isolated from amniotic fluid (abstract, page 1, example 2, page 10), amniotic fluid contains fibroblast-like cells, as evidenced by Arnhold et al., 2011 (introduction , page 1).
Regarding claim 17, the combined arts of Block and Shih teaches the requisite structure of the claimed invention. Therefore, any characteristic inherent to the claimed composition would have been obvious to a person of ordinary skill in the art.
Regarding claims 19 and 20, these claims recite intended uses of the extracellular matrix of claim 11 and do not carry patentable weight.
Hence, the claimed invention as a whole was prima facie obvious.
Conclusion
No claim is allowed
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/HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
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