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.
Current Status of 18/010,440
This Office Action is responsive to the amended claims of 4 March 2026.
Claims 1, 6, 8, 11-12, 16, and 24 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, being claims 13-22, via telephone election on 30 October 2025 is acknowledged. Claims 1, 6, 8, and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Applicant’s claim for the benefit of the prior-filed patent application PCT/GB2021/051478 (filed 14 June 2021) and GB 2009098.1 (filed 15 June 2020) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the instant claims is 14 June 2021, because sufficient support was not found in earlier-filed documents.
Information Disclosure Statement
The information disclosure statement (IDS) received on 3 March 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Response to Arguments
Applicant argues that NEGROTTO teaches metformin and pioglitazone as alternatives. Applicant argues that NEGROTTO teaches the use of metformin and pioglitazone to treat metabolic syndrome. Applicant argues that NEGROTTO does not teach or suggest that treatment with metformin or pioglitazone “acts on MS neurones directly”, but instead indirectly through treating metabolic syndrome. Applicant argues that the inventors have gained a new understanding of demyelinating disorders.
The Examiner has withdrawn the previous claim rejections under 35 USC 102. Combining two therapeutic agents known to be useful for the same condition is well known in the pharmaceutical arts. See the quoted portion of In re Kerkhoven below.
NEGROTTO teaches “Treatment with metformin and pioglitazone has beneficial anti-inflammatory effects in patients with MS and MetS” (Conclusions and Relevance section). The title of the NEGROTTO article is “Immunologic Effects of Metformin and Pioglitazone Treatment on Metabolic Syndrome and Multiple Sclerosis”. The patients described within NEGROTTO were all diagnosed with MS and metabolic syndrome, treated with either metformin or pioglitazone, and both treatment groups showed significant improvement. One of ordinary skill in the art would understand these teachings to clearly indicate that metformin and pioglitazone administration were known to be beneficial to MS patients, at least to the subpopulation also having metabolic syndrome.
Response to Amendments
The objections to the drawings, present in the previous office action, are hereby withdrawn due to the replacement drawing sheets.
The objections to the specification, present in the previous office action, are hereby withdrawn due to Applicant’s arguments.
The objections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s cancellation of claims.
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s cancellation of claims.
The 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
The 35 U.S.C. 103 rejections to the claims, present in the previous office action, are maintained herein, although they have been altered as necessitated by Applicant’s amendments.
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 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.
Claims 16 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over:
NEGROTTO (Cited by Applicant in IDS of 14 December 2022; Negrotto, L.; Farez, M.F.; Correale, J; “Immunologic Effects of Metformin and Pioglitazone Treatment on Metabolic Syndrome and Multiple Sclerosis” JAMA Neurol 2016;73;(5):520-528.).
Regarding claims 16-20: NEGROTTO teaches that twenty patients were administered metformin hydrochloride and 10 patients were administered pioglitazone hydrochloride, all of whom were diagnosed with multiple sclerosis (MS) (Design, Setting, and Participants section). NEGROTTO teaches that all of the patients treated with either drug showed significant signs of improvement, including a lower average number of new brain lesions, compared to the control population (Results section). NEGROTTO teaches “Treatment with metformin and pioglitazone has beneficial anti-inflammatory effects in patients with MS” (Conclusions and Relevance section).
The instant claims and specification state each of the following as facts: each of pioglitazone and rosiglitazone fall within the genus of “a thiazolidinedione” (claim 24); MS is a demyelinating disorder (Pg. 4, 3rd paragraph); pioglitazone is suitable for mobilizing mitochondria in neurons (Pg. 5, 2nd paragraph); and metformin is a remyelination agent (claim 16).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to combine the methods of administering metformin for the treatment of MS, and administering pioglitazone for the treatment of MS, to produce a method of administering metformin and pioglitazone in combination for the treatment of MS, for the purpose of increasing the efficacy of the anti-MS therapy. One of ordinary skill in the art would have expected success in this combination because both compounds are taught by the same reference to be separately useful to treat the same condition, being MS.
This is an example of combining equivalent therapeutic agents known to be useful for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06.
Conclusion
No claims are currently allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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