DETAILED ACTION
This action is in response to Applicant’s submission dated January 28, 2026, in which Applicant elected the invention of Group I without traverse, canceled claims 2-5, 8-9, 13, 19-20, 26, 28, 32-34, 36-37, and 39, and amended claims 1, 6, 10, 22-25, 30, and 38.
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 .
Information Disclosure Statement
The references contained in the IDSs dated August 22, 2023; February 28, 2024; July 28, 2025; and September 25, 2025 are made of record.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Determining the scope and contents of the prior art.
Claims 1, 6-7, 10-12, 14-18, 21-25, 27, 29-31, 35, and 38 are rejected under 35 U.S.C. § 103 as being unpatentable over Kent, et al., US 2020/0237881.
Kent, et al. discloses a method of treating gout in a patient having a serum uric acid (SUA) level of >/= 6 mg/dL (claim 1 “method of treating gout in a patient having a serum uric acid (SUA) level of >/= 6 mg/dL”) comprising: administering methotrexate (MTX) to said patient at a dose of about 15 mg per week for a period of 2 to 4 weeks prior to a first administration of a PEGylated uricase (claim 1- “administering methotrexate (MTX) to said patient at a dose of about 5 mg to about 50 mg per week for a period of 4 weeks prior to a first administration of a PEGylated uricase”; claim 3- “MTX is administered art a dose of 15 mg”); and co-administering the PEGylated uricase and MTX to said patient using a dosage regimen comprising a dose of about 8 mg to about 32 mg of the PEGylated uricase intravenously every 2 to 4 for a total of 6 to 26 doses, and a dose of about 15 mg of MTX per week (claim 1- “co-administering the PEGylated uricase and MTX to said patient using a dosage regimen comprising a dose of about 0.5 mg to about 24 mg of the PEGylated uricase intravenously every 2 weeks for a total of 26 doses, and a dose of about 5 to about 50 mg of MTX per week”; claim 3- “MTX is administered at a dose of 15 mg”), wherein the co-administered MTX is administered concurrently with each administration of the PEGylated uricase (claim 1- “wherein the co-administered MTX is administered concurrently with each administration of the PEGylated uricase”); wherein the PEGylated uricase is administered over an infusion period of 60 minutes or less (para [0040]- “the uricase is administered by intravenous infusion over a 30- to 240-minute period”); but does not teach wherein the infusion volume is about 50 mL. However, Kent, et al. teaches administering Pegylated uricase by intravenous infusion (claim 1- “PEGylated uricase intravenously every 2 weeks for a total of 26 doses”) and a method to reduce the immunogenicity (para [0012]- “disclosure provides a method of reducing immunogenicity to a PEGylated uricase and prolonging the urate lowering effect comprising co-administration of the PEGylated uricase at a dosage of 8 mg intravenously every 2 weeks”). Therefore, it would have been obvious to one of ordinary skill in the art, to have used the teachings of Botson, et al. and optimized the infusion volume to achieve a desired treatment efficiency, using routine experimentation.
Regarding claim 7, Kent, et al. makes obvious the method of claim 1, and teaches further comprising administering folic acid to said patient at a dosage of 1 mg per day (claim 4- “further comprising administering folic acid to said patient at a dosage of 1 mg per day”).
Regarding claim 10, Kent, et al. makes obvious the method of claim 1, and teaches further comprising a prophylactic regimen of colchicine for a period of at least 2 weeks prior to the first administration of the PEGylated uricase (claim 7).
Regarding claim 24, Kent, et al. makes obvious the method of claim 1, and teaches wherein MTX is administered for a period of 3 weeks prior to a first administration of a PEGylated uricase (para [0044]- “MTX may be administered for a specified period before KXX treatment begins (i.e., pre-dosing of MTX), which may be referred to herein as an MTX “lead-in” period. A lead-in period may begin, for example… 4 weeks, 3 weeks…”).
Regarding claim 25, Kent, et al. makes obvious the method of claim 1, and teaches wherein MTX is administered for a period of 4 weeks prior to a first administration of a PEGylated uricase (para [0044]- “MTX may be administered for a specified period before KXX treatment begins (i.e., pre-dosing of MTX), which may be referred to herein as an MTX “lead-in” period. A lead-in period may begin, for example… 4 weeks, 3 weeks…”).
Regarding claim 27, Kent, et al. makes obvious the method of claim 1, and further teaches wherein the PEGylated uricase is administered at a dose of about 8 mg (para [0040]-“The recommended dose and regimen of KXX for adult patients is 8 mg (uricase protein) given as an intravenous (IV) infusion every 2 weeks”).
Regarding claim 29, Kent, et al. makes obvious the method of claim 1, and further teaches wherein the PEGylated uricase is administered at a dose of about 16 mg (para [0062]-“ KXX may include a dose of 8 mg, 12 mg, or 16 mg KXX intravenously at the first week of treatment for a total of one dose”).
Regarding claim 30, Kent, et al. makes obvious the method of claim 1, but does not specify wherein the PEGylated uricase is administered at a dose of about 20 mg. Botson, et al., teaches administering PEGylated uricase at a range of doses; however, (para [0040]- “KXX may be administered at a dosage of 0.5 to 24 mg of uricase in solution every 2 to 4 weeks . The uricase may be administered in any appropriate way known to one of skill in the art, for example intravenously, intramuscularly or subcutaneously”) a method to reduce the immunogenicity (para [0012]- “disclosure provides a method of reducing immunogenicity to a PEGylated uricase and prolonging the urate lowering effect comprising co-administration of the PEGylated uricase at a dosage of 8 mg intravenously every 2 weeks”). Therefore, it would have been obvious to one of ordinary skill in the art, to have used the teachings of the reference and optimize the dose to achieve a desired treatment efficiency, using routine experimentation.
Regarding claim 31, Kent, et al. makes obvious the method of claim 1, and further teaches wherein the PEGylated uricase is administered at a dose of about 24 mg (para [0040]- wherein the administration … 4 to 24 mg of uricase is administered”).
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Claims 1, 6-7, 10-12, 14-18, 21-25, 27, 29-31, 35, and 38 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-3, 5-12, 15, 18, 21, and 24-34 of United States Patent Application No. 17/668,015, which published as US 2022/0323445. Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are directed to administering the same methotrexate and PEGylated uricase regimen to the same population to be treated for the same conditions of gout. Both claim sets further include administering folic acid and colchicine in the same regimen and include the same intended reduced serum uric acid levels, side effects, etc.
This obviousness-type double patenting rejection is provisional because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932