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 .
Claim Status
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 30 October 2024, in which applicants canceled claims 8, 10, 13, 15, 17-20, 22, 24, 30, 32, 35, 37, 39, 41; amended claims 1, 3, 7, 23, 31, 34, 40.
Therefore, claims 1-8, 11-12, 14, 16, 21, 23, 25-29, 31, 33-34, 36, 38, 40 are pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group 2 claims 25-29, 31, 33-34, 36, 38, 40 drawn to an in vitro method of generating a UCP1-positive, Gata6-positive, and/or Pparg positive brown adipocyte organoid in the reply filed on 07 August 2026 is acknowledged.
Claims 1-7, 9,11-12, 14, 16, 21, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim
Claims 25-29, 31, 33-34, 36, 38, 40 are under current examination.
Priority
This application was filed 07/31/2024 and is a 371 application of PCT/US2023/061754 filed on 02/01/2023, which claims benefit to the Provisional Application 63305390 filed on 02/01/2022. Thus, the earliest possible priority for the instant application is 02/01/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/09/2025, 02/13/2026, and 08/07/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and the signed and initialed PTO Forms 1449 are mailed with this action.
Objection to Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because the drawing filed 31 July 2024 in p. 15 figures has been listed as FIGs. 6A, 5B, 6C, 6D and 6E. Applicant needs to fix the typographical error, it should be 6B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 25-29, 31, 33-34, 36, 38, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Pourquie et al (US20190203177A1, Pub. Date: Jul. 4, 2019; cited in IDS filed 04/09/2025; hereinafter “Pourquie”), in view of the publication entitled Shaw, et al. (Pharmaceuticals (Basel) 2021 Oct 25;14(11):1078; cited in IDS filed 04/09/2025; hereinafter "Shaw"), and Maharjan, et al. (Biosci Rep (2020) 40 (5): BSR20194262; cited in IDS filed 04/09/2025; hereinafter "Maharjan") and Lo et al. (Adipocyte, 5(2), 224–231, 2016; cited in IDS filed 04/09/2025; hereinafter "Lo").
Regarding claims 25, 38, Pourquie discloses an in vitro method of generating a UCP1-positive, Gata6-positive, and/or Pparg positive brown adipocyte organoid, the method comprising culturing a PAX3-positive somite-like structure in a medium comprising effective amounts of each of an FGF signaling pathway activator (i.e., FGF2 [0099]) ([0004]-[0006] of Pourquie). Pourquie further discloses generating a UCP1-positive brown adipocyte organoid by culturing a PAX3-positive somite-like structure in a medium comprising effective amounts of triiodothyronine (T3) ([0004]-[0006] of Pourquie). It would have been obvious to a person of ordinary skill in the art, at the lime of the invention, to have modified the method, as previously disclosed by Pourquie, for the integration of generating a UCP1-positive brown adipocyte organoid by culturing a PAX3-positive somite-like structure in a medium comprising effective amounts of triiodothyronine (T3), based on the teachings of the alternative embodiment of Pourquie, as this modification would provide a medium comprising a combination of an FGF activator and T3 for differentiating PAX3-positive somite-like cells into brown adipose tissue, thereby providing an improved medium for brown adipocyte differentiation.
Pourquie does not disclose a medium comprising effective amounts of each of a BMP signaling pathway activator, a TGF beta signaling pathway activator and a Wnt signaling pathway inhibitor. However, such was known in the prior art.
Regarding claims 25 and 33, Shaw discloses that BMP signaling pathway activator (i.e., BMP7) upregulates UCP1 expression in selected clones of immortalized white and brown preadipocytes derived from human neck (p. 2, 2nd ¶).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method, as previously disclosed by Pourquie, for the integration of a BMP signaling pathway activator, as previously disclosed by Shaw, to provide the benefit of regulating the expression of UCP1 in the differentiation medium to obtain brown adipocyte tissue.
Regarding claims 25, and 36, Maharjan discloses a TGF[Symbol font/0x62] signaling pathway activator included (i.e., TGF[Symbol font/0x62]1) to culture medium enhance the cells to differentiate to brown adipose tissue (abstract of Maharjan).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method, as previously disclosed by Pourquie, to integrate a TGF beta signaling pathway activator, as previously disclosed by Maharjan, to provide the benefit of regulating the TGF beta signaling pathway in the differentiation medium to obtain brown adipocyte tissue.
Regarding claims 25, and 34, Lo discloses a Wnt signaling pathway inhibitor enhances browning of adipocyte progenitor cells and Wnt inhibitor C59 added for 6 d from the start of differentiation led to increased expression of thermogenic marker UCP1 (p. 225, 1st Col. 1st and 2nd ¶s).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method, as previously disclosed by Pourquie, to integrate a Wnt signaling pathway inhibitor, as previously disclosed by Lo, to provide the benefit of regulating the Wnt signaling pathway in the differentiation medium to obtain brown adipocyte tissue.
Regarding claim 26, Pourquie discloses that the PAX3-positive somite-like structure is generated by a method comprising culturing a pluripotent cell, preferably an induced pluripotent stem cell (iPSC) or embryonic stem (ES) cell in a medium comprising effective amounts of each of a Wnt activator and a bone morphogenetic protein (BMP) inhibitor, to generate a PAX3-positive somite-like structure (the progenitor cells are induced paraxial mesoderm cells, preferably derived from iPS cells or ES cells, express Pax3, and are cultured in the presence of a Wnt activator and a BMP inhibitor, which would intrinsically result in generation of a PAX3-positive somite-like structure ([0037], [0040]-[0041] of Pourquie).
Regarding claim 27, Pourquie discloses that the Wnt signaling pathway activator comprises at least one of Wnt-1, Wnt-2, Wnt-2b, Wnt-3a, Wnt-4, Wnt-5a, Wnt-5b, Wnt-6, Wnt-7a, Wnt-7a/b, Wnt-7b, Wnt-8a, Wnt-8b, Wnt-9a,Wnt-9b, Wnt-10a, Wnt-10b, Wnt-11, Wnt-16b, Wnt-3, R-spondin1, R-spondin2, R-spondin3, R-spondin4, and combinations thereof ([0047] of Pourquie).
Regarding claim 28, Pourquie discloses that the Wnt signaling pathway activator comprises CHIR99021 ([0091] of Pourquie).
Regarding claim 29, Pourquie discloses that the BMP signaling pathway inhibitors include noggin, chordin, or LDN193189, a dorsomorphin derivative ([0050] of Pourquie).
Regarding claim 31, Pourquie discloses that the FGF signaling pathway activator is FGF2 ([0099] of Pourquie).
Regarding claim 40, Pourquie discloses that the adipogenic differentiation medium comprises DMEM high glucose medium supplemented with serum-free serum replacement, ITS, IBMX, T3, dexamethasone, and rosiglitazone ([0064] of Pourquie).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic, can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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