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. Status of Application /Claims Claims 16-20 submitted on 3/11/2024 are pending and are examined in the present Office Action. Priority Applicant’s claim for the benefit of a prior-filed application JP 2015-207529, 371 of PCT/JP2016/081187 and DIV of 15/769,595 filed on 10/21/2015, 10/20/2016 and 9/17/2018, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged. Accordingly, the effective priority date of the instant application is granted as 10/21/2016. Information Disclosure Statement The information disclosure statement (IDS) submitted on 12/22/2023, 7/30/2024 and 6/30/2025 were received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner. Claim Rejections - 35 USC§ 112, Scope of Enablement The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 16-18 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph , because the specification, while being enabling for converting a specific type of somatic cell into another specific type of somatic cell (i.e. fibroblast is converted into brown adipocyte), does not reasonably provide enablement for a method for converting ANY somatic cell into a brown adipocyte as presently claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the claimed method for the direct conversion of ANY somatic cell into a brown adipocyte in the presence of a TGFβ pathway inhibitor as presently claimed. This rejection is supported by the disclosure of Kishida et al. WO 2014/010746, publication date 1/16/2014 (hereinafter Kishida). The factors listed below have been considered in the analysis of enablement regarding methods for wound healing comprising the administration of ANY antidepressant : (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. The breadth of claims read on a method to convert ANY somatic cell into a brown adipocyte, which is considered extraordinarily broad. The current claim language seemingly encompasses the conversion of any somatic cell type, including cardiac cells, enterocytes, fat cells, red blood cells, chondrocytes, epithelial cells, neurons into any one of the roughly +220 somatic cell types known. This is in stark contrast to the applicant’s specification, wherein examples are provided supporting the conversion of fibroblasts into specific somatic cell types largely within the mesodermal germ layer (adipocytes, mesenchymal cells, osteoblasts and cardiac muscle cells). The nature of the invention relates to the conversion of ANY somatic cell into brown adipocytes through incubating in the presence of a TGFβ pathway inhibitor. The state of the prior art is silent on how any specific TGFβ pathway inhibitor would be able to convert any somatic cell into brown adipocytes . For example, Kishida shows that only under specific culturing conditions and targeting specific reprogramming-related genes was it possible to convert fibroblasts (a specific somatic cell type) into brown adipocytes ( Kishida, abstract and para 66). Thus, predictably converting any type of somatic cell to a brown adipocyte in the presence of a TGFβ pathway inhibitor would not be achievable without precise culturing controls and supplemental factors. Applicant’s specification provides enabling embodiments wherein a specific TGFβ inhibitor (namely ALK5 inhibitor II) is used to convert fibroblast cells into osteoblast cells in addition to defined supplemental media components including DMEM, glycerophosphate, Dexamethasone and ascorbic acid (Instant specification, example 23). Thus, applicant is not enabled for the conversion of ANY somatic cell into brown adipocytes via culturing in the presence of ANY TGFβ pathway inhibitor without precisely defining the input/output cell type, specific TGFβ inhibitor as well as any essential supplemental media components which would lead one of ordinary skill in the art to practice the claimed invention without undue experimentation. Claim Rejections - 35 USC § 112, Written Description The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 16 and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. This rejection is supported by Massagué et al. "Controlling TGF-β signaling." Genes & development 14.6 (2000): 627-644 (hereinafter Massagué ). The genus of “ TGFβ pathway inhibitor ” refers to a genus that is considered extraordinarily broad. It is thought to encompass any inhibitor which acts on any part of the TGFβ signaling pathway via the receptor complex, Smads and/or transcriptional complex. It encompasses potentially thousands of targets both known and those which are yet to be discovered. For each claim drawn to a genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in procession of the claimed genius. If a representative number of adequately descried species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1. The instant specification exemplifies the use of approximately 5 TGFβ pathway inhibitors which are largely tested in the in vitro context. For example, the instant specification exemplifies the use of ALK5 inhibitor II and its role as an ATP-competitive inhibitor of TGFβ RI kinase. This is not considered a representative number of samples to support the claim to any TGFβ pathway inhibitor , in part because this inhibitor affects only one specific part of the TGFβ signaling pathway , but also because the genus of any TGFβ pathway inhibitor is so large ranging from inhibitors which act on the TGFβ receptor complex, to that which act on downstream SMAD signal transduction or transcriptional events. Given the breadth of the genus of any TGFβ pathway inhibitor in contrast to the exemplified and prophetic proportions of the specification, which are largely drawn to just several specific TGFβ inhibitors , the instant specification does not adequately disclose a sufficient number of adequately described species of the genus of any TGFβ pathway inhibitor. Furthermore, the prior art does not support the breadth of applicants claim to any TGFβ pathway inhibitor . In particular, t he prior art reveals a wide variety of TGFβ pathway targets with varying inhibitor mechanisms and specificity. This is supported by Massagué , wherein Smad pathway inhibitors (Fig 6), TGFβ receptor complex inhibitors (Fig 1) and various ligand-binding proteins (Fig 4) are described. Massagué shows that there is a great deal of variability within the art relating to the design and selection of a particular TGFβ signaling pathway inhibitor with wide-ranging outcomes ( Massagué , discussion). Thus, although the specification prophetically considers and discloses a select group of TGFβ pathway inhibitors , the instant specification does not disclose a sufficient number of adequately described species to support the claim to any TGFβ pathway inhibitor. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kishida ( supra ) in view of Hebrok et al. US20180216076, published 8/2/2018, priority date 7/27/2015 (hereinafter Hebrok ). Claims 16 and 19: Kishida describes a method for generating brown adipocytes comprising converting fibroblasts (somatic cells) in a differentiation induction medium comprising insulin, IBMX, dexamethasone, idomethacine , T3 and rosiglitazone (Kishida, intro). Kishida states that Sox2 is an important brown adipocyte related gene which can be induced to obtain brown adipocytes from somatic cells (Kishida, para 66-67 and 71). Claim 20: Kishida describes the use of rosiglitazone, which is a known PPAR-γ agonist ( Kishida, example 1). Kishida does not describe culturing brown adipocytes in the presence of a TGF-β pathway inhibitor. Claims 16-18: Hebrok describes a method for converting pancreatic endothermal progenitor cells (a type of somatic cell) to pancreatic beta-like cells (another type of somatic cell) by contacting the cells with a TGF-β pathway inhibitor, with specific reference to an Alk5 inhibitor II ( Hebrok , para 26, 61, 252) . Hebrok describes Alk5 inhibitor II as a selective and ATP-competitive inhibitor of the TGF-β family type 1 receptor activating receptor-like kinase (ALK5) that can replace Sox2 when reprogramming cells ( Hebrok , para 252). It would have been obvious to one of ordinary skill in the art to use an Alk5 inhibitor II as described by Hebrok to facilitate the direct conversion of fibroblasts into brown adipocytes in the methods for direct conversion described by Kishida. It would have been a matter of combining prior art elements according to known methods to yield predictable results since both authors are concerned with the direct conversion of somatic cells. Hebrok expressly states that Alk5 inhibitor II acts a selective and ATP-competitive inhibitor of the TGF-β family type 1 receptor activating receptor-like kinase (ALK5) that can replace Sox2 when reprogramming cells ( Hebrok , para 252). Kishida found that Sox2 is an important brown adipocyte related gene which can be induced to obtain brown adipocytes from somatic cells (Kishida, para 66-67 and 71). Thus, one of ordinary skill would have motivation to include Alk5 inhibitor II into the methods of Kishida given its role as a replacement for Sox2. One would have a reasonable expectation of success in using Alk5 inhibitor II for the direct conversion of fibroblasts into brown adipocytes given the well understood mechanisms of action of Alk5 on the TGF-β pathway and Sox2. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made. Nonstatutory Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Langi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717 .02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP 706.02(1)(1) - 706.02(1)(3) for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claims 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US Patent No. 11,459,546 . Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims would anticipate the instant claims if they were available as prior art. The patented claims are drawn to a method for producing brown adipocytes comprising culturing fibroblasts in the presence of an ALK5 inhibitor. The patented claims would anticipate the instantly claimed invention, which is drawn to a similar method for generating brown adipocytes comprising culturing fibroblasts in the presence of a TGF-β inhibitor like an ALK5 inhibitor. The claim sets are patentable indistinct therefore. Claims 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-21 of copending Application No: 18/517,402. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims would anticipate the instant claims if they were available as prior art. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The competing claims are drawn to a method for generating a brown adipocyte comprising culturing a fibroblast in the presence of a TGF-β inhibitor comprising ALK-5 inhibitor II. The competing claims would fully anticipate the instantly claimed invention, which is drawn to a similar method for generating brown adipocytes comprising culturing fibroblasts in the presence of a TGF-β inhibitor like an ALK5 inhibitor. The claim sets are patentable indistinct therefore. Thus, the presently claimed invention embraces the copending competing claims. Conclusion Claims 16-20 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Dr. ALEXANDER NICOL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6383 . The examiner can normally be reached on FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8-5 EST . 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For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Alexander Nicol Patent Examiner Art Unit 1633 /ALEXANDER W NICOL/ Examiner, Art Unit 1634