DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, 17920313, PG-Publication US 20230340419, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-26, and 29 are pending. Claims 1-23 are withdrawn. Claims 24-26 and 29 are rejected.
Election/Restrictions
1. Claims 1-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025. Claims 24-26 and 29 are examined here below.
2. The requirement under lack of unit, mailed 9/17/2025, at p. 4, was on the ground that the technical feature linking the claims “appears to be renal and renal derived cells cultured in media,” which did not constitute a contribution over the prior art, in view of the prior art reference of Tsujimoto, (2020) Cell Reports 31, Page 1 to 14 and e1 to e7, (of record, IDS). This requirement is maintained as proper and an analysis is updated herewith. The invention of supplement compositions do not recite renal or renal derived cells cultured in media and so elected Group IV, product/composition claims 24-26 and 29, which do not recite cells, are not related to the method Inventions of Groups I-III, except for a generic limitation for the intended use in “a medium”. The invention of Group IV is not considered to require the listed compositions to be formulated in such a “medium.”
Priority
The filing receipt, mailed 7/19/2023, states that this application, filed 10/20/2022, is a 371 of PCT/US2021/029390, filed 04/27/2021, which claims benefit of 63/016,225, filed 04/27/2020 and claims benefit of 63/163,676, filed 03/19/2021
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/20/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 26 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 26 contains the trademark/trade name “GlutaMAX-I” and Claims 26 and 29 contain, at least, the trademark/trade names “GlutaMAX-I”, “B-27”, “insulin-transferrin-sodium selenite ‘ITS’ solution”, and “KNOCKOUT serum replacement (KSR)”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the aforementioned additives, and furthermore do not display a trademark for these commercially available products and, accordingly, the identification/description is indefinite.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
1. Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Mae, 2017, Biochem Biophys Res Communications, vol 495, pages 954 to 961 plus supplements, (of record, IDS); Harel, 2015, Science Advances, vol 1, number 9, pages 1 to 12; Salahudeen, US 20210155989; .
Mae, throughout the publication and abstract, teach induction of branching ureteric bud (UB) tissue from human pluripotent stem cells. Mae, at p. 956, teach growth factor and small molecules used in their growth medium and as tabulated in Supplemental Table 1. Table 1 includes A83-01, CHIR99021, GDNF, LDN193189. Mae does not teach medium comprising Y27632.
Mae does not teach JAK Inhibitor I, R-spondin 1, fibroblast growth factor (FGF) 7, FGF7SP202190, or epidermal growth factor (EGF).
Harel, throughout the publication and abstract and at p. 6 of 12, teaches that Janus kinase inhibitors results in hair follicle growth by stimulating the activation and / or proliferation of hair follicle stem cells. Harel, at p. 8 of 12, suggest that JAK may prove useful in directly targeting stem cells and their respective niches.
Salahudeen, US 20210155989, throughout the publication and abstract and teaches at para [0004], [0159], R-Spondin 1, and para [0333], Table 7and 8, teaches tumor organoid culture media comprising EGF, FGF7, SB202190 which the media contains DMEM, GlutaMax, B-27 without vitamin A, penicillin-streptomycin, A83-01.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined JAK Inhibitor I, R-spondin 1, fibroblast growth factor (FGF) 7, FGF7SP202190, or epidermal growth factor (EGF), as taught in Harel and Salahudeen, into the medium for induction of branching ureteric bud (UB) tissue from human pluripotent stem cells, as taught by Mae.
One of ordinary skill in the art would have motivated to have combined these various factors taught in the art to the media taught by Mae, as they are used to support growth of stem cells or organoids in culture.
Conclusion
1. Claims 24-26 are rejected.
2. The examined prior art does not teach or fairly suggest aldosterone or vasopressin as additives for media used to culture stem cells or organoids.
2. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz, can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631