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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/23/2026 has been entered.
Claim Status
Claims 1 and 27-43 are pending.
Claims 2-26 were previously cancelled.
Claims 1, 27, 28, 36, 38, and 39 are currently amended.
Claims 42 and 43 are newly added.
Claims 1 and 27-43 have been examined.
Claims 1 and 27-43 are rejected.
Priority
Priority to 371 PCT/JP2021/019622 filed on 05/24/2021, which claims priority to Japanese patent application 2020-090194 filed on 05/25/2020 is acknowledged.
Drawings
The drawings filed on 11/17/2022 are accepted.
Withdrawn Claim Rejections - 35 USC § 102
Response to Applicant’s Arguments
The rejection of claim(s) 1, 27, 28, and 31-40 under 35 U.S.C. 102(a)(1) as being anticipated by Cole et al. (Ziprasidone for Agitation or Psychosis in Dementia: Four Cases, Published 03/01/2005) as evidenced by Korey et al. (International Application Published Under the PCT WO 0192238 A1, Published 12/06/2001), Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018), and Gatticchi et al. (Selected cholesterol biosynthesis inhibitors produce accumulation of the intermediate FF-MAS that targets nucleus and activates LXRα in HepG2 cells, Published 05/09/2017) is withdrawn in view of the amendments to the claims.
Withdrawn and New Claim Rejections - 35 USC § 103
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.
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.
Response to Applicant’s Arguments
The rejection of claims Claim(s) 29, 30 and 41 under 35 U.S.C. 103 as being unpatentable over Benavides et al. (Japanese Patent application publication H0840902 A, Published 02/13/1996) as evidenced by Tesar et al. (International Application Published Under the PCT WO 2018/022904 A2, Published 02/01/2018) and Gatticchi et al. (Selected cholesterol biosynthesis inhibitors produce accumulation of the intermediate FF-MAS that targets nucleus and activates LXRα in HepG2 cells, Published 05/09/2017) is withdrawn in view of Applicant’s arguments as to the translation of Benavides et al.
This is a new ground of rejection.
Claim(s) 1, 27, 28, 36-40, 42, and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drew et al. (International Application Published Under the PCT Wo 2020/072456 A1, Published 04/09/2020).
Drew et al. teach Compound 10 inhibits TM7SF2 (paragraph 0061). Compound 10 strongly promotes oligodendrocyte formation (paragraph 0060). Compound 10 has the structure:
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(Table 1). A method of treating a neurodegenerative disease or disorder in a subject, wherein the neurodegenerative disease or disorder is a myelin related disorder (paragraph 0036). Examples of myelin related diseases and disorders are multiple sclerosis (MS), amylotrophic lateral sclerosis (ALS), Alzheimer's disease, Parkinson's disease, etc. (paragraph 0040). With regard to the limitation “for protecting and/or regenerating a neuromuscular junction” is an inherent property to the method and compound 10.
Drew does not teach a preferred embodiment wherein an agent that is an inhibitor of FF-MAS metabolism. However, Drew does make such a method obvious.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing of the instant application to administer compound 10 for treatment of Parkinson’s disease, amyotrophic lateral sclerosis, and Alzheimer’s disease and have a reasonable expectation of success. One would have been motivated to do so since Drew et al. teach that compound 10 is an inhibitor of TM7SF2 and strongly promotes oligodendrocyte formation. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
This is a new ground of rejection.
Claim(s) 29-35 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drew et al. (International Application Published Under the PCT Wo 2020/072456 A1, Published 04/09/2020) as applied to claims 1, 27, 28, 36-40, 42, and 43 above, and further in view of Nelson (US Patent Application Publication 2010/0330117 A1, Published 12/30/2010).
The teaching of Drew et al. is discussed above.
Drew et al. does not teach treating muscular dystrophy.
Nelson et al. teach muscular dystrophy is a disease associated with demyelination of the nerves (abstract).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing of the instant application to administer compound 10 for treatment of muscular dystrophy and have a reasonable expectation of success. One would have been motivated to do so since Drew et al. teach the compounds are administered for treating myelin related diseases. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Conclusion
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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