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 .
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.
Election/Restrictions
Applicant’s election of Group I (claims 1, 9, 16, and 56-59), in the reply filed on 22 September 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants’ election of species: “chronic kidney disease” (as species of “kidney disease”) and “siRNA” as species of “ALDH1L1 inhibitor” in the reply filed on 22 September 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants’ compliant species election of “siRNA” and “chronic kidney disease” as utilized in the method of instant claim 1 is free of the prior art.
Therefore, following Markush search practice, the Markush search was extended to “disulfiram” (which is another species of “Aldehyde Dehydrogenase 1 Family Member L1 (ALDH1L1) inhibitor”) being used to treat “chronic kidney disease” according to method claim 1. This search retrieved prior art. Therefore, in accordance with Markush search practice, the Markush search will not be extended unnecessarily to additional species of “inhibitor” or “kidney disease” in this Office Action.
Claim 1 reads on the “disulfiram” and “chronic kidney disease” of elected Group I.
Claims 9, 16, and 56-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of “inhibitor”, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 September 2025. These claims are withdrawn since they are drawn to nucleic acids as species of “inhibitor”. However, the “disulfiram” of the Markush search extension, above, which has prior art, is not a “nucleic acid”. These claims will be rejoined during subsequent Markush search extensions into other “inhibitors” and “kidney diseases” in future Office Actions.
NOTE: Applicants should note that withdrawn claims 56-59 drawn to “the variant nucleic acid molecules” of claim 1, lack antecedent basis with claim 1 (hence will be indefinite once rejoined) and do not properly further limit parent claim 1 (claim 1 is silent as to “nucleic acids”) (hence will be rejected under 35 USC 112(d) once rejoined). Please revise these claims or cancel to expedite allowance.
Claims 60-66, 73, and 80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention of Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 September 2025.
Current Status of 17/934,277
This Office Action is responsive to the amended claims of 21 December 2022.
Currently amended claim 1 has been examined on the merits.
Priority
The effective filing date is 23 September 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2 February 2023, 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 § 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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
ZHANG (Zhang, Yu, et al. “Disulfiram inhibits inflammation and fibrosis in a rat unilateral ureteral obstruction model by inhibiting gasdermin D cleavage and pyroptosis.” Inflammation Research. (May 2021) 70: 543-552, provided by Applicants-see IDS of 2 February 2023),
as evidenced by:
COOK (Cook, Robert J., et al. “Enzymatic Activities of Rat Liver Cytosol 10-Formyltetrahydrofolate Dehydrogenase.” Archives of Biochemistry and Biophysics. (1995), Vol. 321, No. 2, August 20, pp. 336-344, provided by Applicants-see IDS of 2 February 2023).
The prior art reference ZHANG teaches that “renal fibrosis is a common pathology of the progression of chronic kidney disease (CKD) to end-stage renal disease” (see “Introduction”, left column on page 543). Thus, the Examiner interprets this to mean that any medicinal compound that inhibits, slows, or reverses renal fibrosis constitutes “treating” or “preventing” chronic kidney disease.
Furthermore, ZHANG teaches that disulfiram inhibits inflammation and fibrosis in renal fibrosis model rats (the “subjects” for instant claim 1) (see “Conclusion” on page 543).
The evidentiary reference COOK is relied upon for the beneficial teaching that disulfiram is an Aldehyde Dehydrogenase I Family Member L1 (ALDH1L1) inhibitor (see COOK left column of page 336; also, see page 12 of 23 of the Written Opinion for PCT/US2022/076838 that reports that “disulfiram is an inhibitor of ALDH1L1”—this can be found under “D11 – XP093013213 – Cook et al., 1995”).
Thus, ZHANG as evidenced by COOK, teaches a method of treating a subject (mice) having chronic kidney disease (CKD) or preventing a subject from developing CKD [ZHANG teaches that disulfiram inhibits inflammation and renal fibrotic progression; ZHANG also teaches renal fibrosis is involved in the progression of CKD, all cited, see above; thus Examiner posits one interpretation is that “inhibition” of further renal fibrosis pathology “prevents” progression of CKD] comprising administering disulfiram (which COOK and Written Opinion evidence is an “ALDH1L1 inhibitor”) to the subject. Thus, this anticipates the method of instant claim 1.
Conclusion
Claim 1 is not presently allowable as written.
The Examiner reviewed the Specification for guidance (enablement) for the full scope of examined instant claim 1.
Applicants provided enablement for the instant claim 1 within the following pages of their 233 page Specification: pages 2-20 tie together the relationship between each class of inhibited receptors of claim 1 (e.g., ALDH1L1) with the concept of treating or preventing any kidney disease. Moreover, page 10 of the Specification discloses that several variant nucleic acid molecules (i.e., ALDH1L1, ALDOB, G6PC, LRP2, RPL3L, SLC25A45, and SLC7A9-all from claim 1) encode a predicted loss-of-function polypeptide associated with some level of risk of developing a kidney disease. Also, these genes (i.e., ALDH1L1, ALDOB, G6PC, LRP2, RPL3L, SLC25A45, and SLC7A9-all from claim 1) are responsible for the protective effect in kidney disease (page 10 Specification). Subjects on the “wrong side” of this risk profile are then given compounds to inhibit these genes (page 17 of Specification). In fact, Examples 1-2 of the Specification provide data backing up these observations (see pages 217-233) and show the relationship between each of the genes and the associated claim 1 kidney diseases. Thus, if one inhibits a loss-of-function gene, then they “prevent” the associated kidney disease. If the disease is already manifest, then the same actions would (at a minimum) “treat” the associated kidney disease.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625