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 the Application
Receipt is acknowledged of the request for continued examination, amendment and response filed 2/20/2026. Claims 1-3,5-11,14-23 and 25-31 are pending in the application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/20/2026 has been entered.
Response to Arguments
Claim amendments render the previous rejection of claims under 35 USC 112(b) and 35 USC 103 moot. However, the claims as amended present new grounds for rejection.
Claim Rejections - 35 USC § 112
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.
Claim 1, 21 and dependent claims 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims require that the recited dietary regimen “repairs kidney tissue” and “restores kidney function”; and “repairs glomerular tissue damage” and “restores glomerular function” respectively in a human subject. However the specification is limited to a rat model demonstrating changes in surrogate markers (e.g. proteinuria, BUN, urinary eGFR, and histology), and further states that the formulation “will be developed for human purposes”. ([0089]) This forward-looking statement indicates that the application of the regimen to humans had not yet been achieved at the time of filing. Accordingly, the specification does not reasonably convey to a person of ordinary skill in the art that the inventors were in possession of methods achieving repair of kidney tissue or restoration of kidney function in humans. The disclosure of biomarker changes in an animal model, without more, does not demonstrate possession of the broadly claimed treatment outcomes. Accordingly, the claimed subject matter is not supported by an adequate written description.
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.
Claim 1,21 and dependent claims 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.
The claims recite “repairs kidney tissue” and “restores kidney function”; and “repairs glomerular tissue damage” and “restores glomerular function”, respectively, in a human subject. These functional limitations lack objective boundaries. Although the specification describes data obtained in rats (e.g. proteinuria, blood urea nitrogen (BUN), urinary eGFR, and histology), it does not define what or type of change constitutes “repair” or “restoration” in a human subject, nor provide objective criteria or thresholds for determining when such results are achieved. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the scope of these limitations.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793
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