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 .
Application Status – Continued Examination Under 37 CFR 1.114
Claims 24-41 were previously pending.
A final rejection office action was mailed on 11 June 2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 October 2025 has been entered.
In their request for continued examination, Applicant has amended claims 24-25, 31-32, and 34-35, and did not cancel or add any additional claims. Therefore, claims 24-41 remain pending and currently under examination.
Information Disclosure Statement
Applicant’s Information Disclosure Statement (IDS) filed 10 December 2025 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Withdrawn Claim Rejections
Upon further search and consideration, all previous claim rejections are withdrawn. New claim rejections are set forth below.
New Claim Rejections
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 Longi, 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
US Patent 11,939,373 B2 (date of patent: 26 March 2024)
Claims 24-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,939,373 B2 (date of patent: 26 March 2024; hereinafter ‘373) in further view of Lukacs (“Therapeutic Mabs for Chronic Kidney Disease,” available online: 28 May 2018 as captured via Wayback Machine).
Although the claims are not identical, they are not patentably distinct from one another as both ‘373 and the currently claimed application are drawn to identical antibodies. The currently claimed invention and ‘373 are directed to an identical anti-SCF248 antibody. In fact, the only difference between the instant claims and ‘373 is that ‘373 is directed to the anti-SCF248 antibody and the instant claims are directed to a method of using the ‘373 antibody to treat inflammatory or fibrotic renal disease in a subject in need of such treatment.
Although ‘373 does not claim a method of using the anti-SCF248 antibody to treat inflammatory or fibrotic renal disease in a subject, it has been previously disclosed in the art that such antibodies may be effective treatment for such diseases.
Lukacs teaches a monoclonal antibody which prevents and treats chronic kidney disease (CKD) that can lead to end stage renal disease (ESRD) and dialysis or kidney transplantation (abstract). Lukacs further teaches Opsidio, LLC (Applicant of both ‘373 and current application) holds the rights to an antibody which binds specifically to SCF248 and not the other forms of SCF that maintain normal functions (abstract). Lukacs also teaches the amount of SCF present in the kidney has been correlated to severity of kidney disease (abstract). Finally, Lukacs details a phase one Small Business Technology Transfer (STTR) where the primary goal will be to validate in animal models of CKD that the monoclonal antibody specific for the SCF248 isoform can arrest and possibly reverse the fibrosis that is the cause of renal failure with a secondary goal showing the anti-SCF248 antibody prevents or reverses CKD in animal models and the same mechanism will be applicable to human models with an ultimate goal of commercializing the anti-SCF248 monoclonal antibody as a drug that can stabilize or reverse renal fibrosis in human CKD patients (abstract).
Considering the teachings of Lukacs, it would have been prima facie obvious, at the time of the claimed invention, to use the antibody disclosed in ‘373 to treat inflammatory or fibrotic renal disease. One of ordinary skill in the art would have been motivated to do so because Lukacs teach the potential of anti-SCF248 antibodies, like the one disclosed in the instant claims and ‘373, to treat inflammatory or fibrotic renal disease. Therefore, the instant claims are anticipated by patent ‘373 in further view of Lukacs.
US Patent 12,410,246 B2 (date of patent: 09 September 2025; cited in previous office actions as co-pending application 18/500,622)
Claims 24-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,410,246 B2 (date of patent: 09 September 2025; hereinafter ‘246) in further view of Lukacs (“Therapeutic Mabs for Chronic Kidney Disease,” available online: 28 May 2018 as captured via Wayback Machine) as evidenced by Sambrook (Molecular Cloning A Laboratory Manual, 2nd edition, Cold Spring Harbor, N.Y., 1989, pages 2.43-2.84) and Jaye (Nucl Acids Res 11(8): 2325-2355, 1983).
Although the claims at issue are not identical, they are not patentably distinct from each other as both ‘246 and the currently claimed application are drawn to identical antibodies. Although ‘246 does not claim a method of using the anti-SCF248 antibody to treat inflammatory or fibrotic renal disease in a subject, it has been previously disclosed in the art that such antibodies may be effective treatment for such diseases. See the above discussion of Lukacs.
Furthermore, ‘246 recites a nucleic acid encoding the antibody instantly claimed.
Although the instant claims are directed a method of using the antibody in which ‘246 claims are directed to nucleic acids encoding such, the patented nucleic acid sequences that encode the instant application’s antibody amino acid sequences can be determined and isolated by conventional methodologies well-known to one of skill in the art at the time of claimed invention. This is evidence in Sambrook (Molecular Cloning A Laboratory Manual, 2nd edition, Cold Spring Harbor, N.Y., 1989, pages 2.43-2.84) and Jaye (Nucl Acids Res 11(8): 2325-2355, 1983). One skilled in the art can also use commercially available computer software to translate the polypeptide sequences of the instant application to nucleic acid sequences (see for example, U.S. Patent 6,399,857; column 6, lines 50-57). There are sets of three nucleotides that make up a codon, many amino acids are specified by more than one codon (degeneracy of the code), and 61 of the 64 possible combinations of three bases are used to code for specific amino acids (the other three code for stop signals) (see Lewin, B. Genes IV, Oxford: Oxford University Press, 1990; pages 118-120, Figure 7.7). See also MPEP 2144(I).
The antibody disclosed in ‘246 is identical to the antibody in the instant application. Although the claims at issue are not identical, as ‘246 is drawn to a nucleic acid encoding the identical antibody, the claims of ‘246 and the instant application are not patentably distinct from each other. Considering the teachings of Lukacs, Sambrook, and Jaye, it would have been prima facie obvious, at the time of the claimed invention, to use the antibody claimed in ‘246 to treat inflammatory or fibrotic renal disease. Lukacs teaches the use of an anti-SCF248 antibody to treat inflammatory or fibrotic renal disease. Furthermore, both Sambrook and Jaye provide evidence that the method of translating nucleic acids to their respective polypeptide sequences was widely known to one of ordinary skill in the art before the effective filing date of the claimed invention. Therefore, in light of the combined references, the instant invention claiming an anti-SCF248 antibody is anticipated by patent ‘246 in further view of Lukacs, Sambrook, and Jaye.
Conclusion
Claims 24-41 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A ROSSI/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644