DETAILED ACTION
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 Group I, presently claims 1-5, in the reply filed on 7/02/2026 is acknowledged.
Claims 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/02/2026.
Claims 1- 5 are under consideration on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by López-Martinez et al. (Frontiers in Bioengineering and Biotechnology (March 2021), 9:639688, 20 pages; Reference U).
López-Martinez teaches a hydrogel composition for three-dimensional culture of endometrial organoids comprising decellularized uterine tissue-derived extracellular matrix (i.e. EndoECM) (page 2, 2nd and 3rd full paragraphs in the right column for preparing the uterine ECM; subheading “Turbidimetric-Kinetic Gelation Assay” on pages 4-5 for further formulation as a hydrogel; Fig. 8 for culturing or endometrial organoids), anticipating claim 1. López-Martinez teaches that EndoECM comprises collagen type VI and fibronectin (Figure 6B), anticipating claim 2. López-Martinez teaches formulating EndoECM as a hydrogel 3 mg/ml, 6 mg/ml, or 8 mg/ml EndoECM (Table 1 and Fig. 5; the paragraph starting on page 9 and ending on page 11), anticipating claims 3-5.
Regarding claims 3 and 4, these claims are read in light of the specification that the disclosed methods of making decellularized porcine uterine tissue by decellularizing the tissue with 1% Triton X-100 and formulated as a hydrogel in an ECM concentration range of 1-8 mg/ml inherently yields the claimed rheological properties. See Examples 1 and 9 of the disclosure. Therefore, any teaching in the prior art towards a decellularized porcine uterine tissue hydrogel composition made by decellularizing the tissue with 1% Triton X-100 and formulated as a hydrogel in an ECM concentration range of 1-8 mg/ml is reasonably presumed to inherently generate/yield the rheological properties of claims 3 and 4 in the absence any showing to the contrary. See M.P.E.P. § 2112(V) and 21112.01(I); when the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established, and the USPTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977). In this case, López-Martinez further teaches making the EndoECM composition from porcine uterine tissue and decellularizing said tissue with a composition comprising 1% Triton X-100 (page 2, right column, paragraph starting “Entire female porcine reproductive tracts…”),and so reasonably anticipates claims 3 and 4.
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.
Claims 3 and 4 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over López-Martinez as applied to claim 1 above and further in view of Yao et al. (ARTIFICIAL CELLS, NANOMEDICINE, AND BIOTECHNOLOGY
2020, VOL. 48, NO. 1, 218–229; Reference V) and Nahas et al. (US 2012/0189588; Reference A).
The teachings of López-Martinez are relied upon as set forth above in rejecting claims 1, 2, and 5 as anticipating under 35 U.S.C. § 102.
Regarding claim 3, López-Martinez does not expressly teach wherein the decellularized uterine tissue-derived extracellular matrix has a higher elastic modulus (G') than a viscous modulus (G") thereof. Regarding claim 4, López-Martinez does not expressly teach wherein the decellularized uterine tissue- derived extracellular matrix has an elastic modulus of 10¹ to 10² Pa and a viscous modulus of 10° 15 to 10¹ Pa when a concentration of the decellularized uterine tissue-derived extracellular matrix is 1 to 8 mg/mL.
Yao teaches a crosslinked decellularized rabbit uterus matrix (dUECM) composition (Abstract). Yao teaches that the rheological properties of the dUECM varies depending on whether the dUECM was crosslinked or not (the paragraph spanning pages 219-220), reading in-part on claims 3 and 4.
Nahas teaches compositions and methods of preparing extracellular matrix from decellularized adipose tissue and for the further culturing of cells (¶0005). Nahas teaches the processed/decellularized adipose tissue having elastic modulus (G’) range of 103-105 Pa and a viscous modulus (G’’) range of 103-105 Pa (¶0017-0018), reading in-part on claims 3 and 4.
Regarding claims 3 and 4, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, the combination of Yao and Nahas clearly teach that the rheological properties of decellularized uterine tissue-derived ECM hydrogel compositions are known result-effective variables, as Yao teaches said rheological properties depend on how the ECM composition is gelated/crosslinked and Nahas clearly teaches that optimizing the elastic and viscous moduli to obtain ECM hydrogels with desirable rheological properties was known and within the skill of a person of ordinary skill in the art. Thus, the burden is shifted back to establish criticality of the claimed moduli relationship for claim 3 and the elastic and viscous moduli ranges of claim 4 by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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