DETAILED ACTION
Claims 1, 4-12 are pending in the instant application.
Claims 1, 4-9, 11-12, wherein
1)-b)-i) serine palmitoyltransferase (SPL/SPTLC)
2)-b)-i) small molecule from Table A=compound 4 are examining. Claim 10 and the remaining subject matter of claims 1, 4-9, 11-12 are withdrawn per 37 CFR 1.142(b).
The requirement is still deemed proper and is therefore made FINAL.
The rejection of claims 1-9, 11-13 under 35 U.S.C. 112, second paragraph is withdrawn in view of applicant’s amendment and argument in paper dated on 06/04/2026.
The rejection of claims 1-9, 11-13 under 35 U.S.C. 101 is withdrawn in view of applicant’s amendment and argument in paper dated on 06/04/2026.
The rejection of claims 1-9, 11-13 under 35 U.S.C. 112, first paragraph is withdrawn in view of applicant’s amendment and argument in paper dated on 06/04/2026.
The rejection of claims 1, 4-9, 11-12 under 35 U.S.C. 102(a)(2) over Asano et al., US 10519110 is maintained for reason of record.
Applicants argue that Asano discloses SPT enzyme inhibitors that can be used to treat Niemann-pick disease, cancer and congenital diseases associated with sphingolipid accumulation. However, Asano does not disclose SPT enzyme inhibitors in a method of treating frailty characterized by sarcopenia and/or muscle atrophy, and cognitive impairment.
It is Examiner’s position that Asano discloses the instant claimed compound on columns 213-214 as follow:
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. On columns 527-528 disclose the above compound can be used for SPT enzyme inhibitor. On columns 531-532 disclose the above compound can be used to treat Niemann-pick disease, cancer, congenital disease associated with sphingolipid accumulation. Niemann-pick disease can be related to muscle comprising sarcopenia, muscle atrophy and cognitive impairment. On the background disclose the sphingolipids include ceramide, sphingomyelin, ganglioside. The scope of claims 8-9 inherently there since Asano inhibit (SPT). Therefore, the instant claims are anticipated by Asano et al.
The rejection of claims 1, 4-9, 11-12 under 35 U.S.C. 102(a)(1) over Adachi et al., Biochemical and Biophysical Research Communications 497 (2018), 1171-1176 is maintained for reason of record.
Applicants argue that Adachi discloses SPT enzyme inhibitors that can be used to treat cancer. However, Adachi does not disclose SPT enzyme inhibitors in a method of treating frailty characterized by sarcopenia and/or muscle atrophy, and cognitive impairment.
It is Examiner’s position that Adachi discloses the instant claimed compound on page 1173 as follow:
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. On abstract and Table 1 disclose the above compound can be used for SPT enzyme inhibition. On columns 531-532 disclose the above compound can be used to treat cancer. Cancer can cause muscle disease too. The scope of claims 8-9 is inherently there since Adachi inhibit (SPT). On abstract and page 1171 disclose the potency of ceramide reduction correlated to that observed in a recombinant SPT2 enzyme assay. Therefore, the instant claims are anticipated by Adachi et al.
The rejection of claims 1, 4-9, 11-12 under 35 U.S.C. 102(a)(1) over Kojima et al., Bioorganic & Medicinal Chemistry 26 (2018), 2452-2465 is maintained for reason of record.
Applicants argue that Kojima is silent as to age-related disease and/or aging and administering an inhibitor of sphingolipids to treat frailty characterized by sarcopenia, muscle atrophy, cognitive impairment.
It is Examiner’s position that Kojima discloses the instant claimed compound on page 2453, figure 2 as follow:
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. On abstract and Figure 3 on page 2457 disclose the above compound can be used for SPT enzyme inhibition. On page 2458, Table 1 shows the above compound has SPT enzyme inhibition activity. On page 2459 disclose the above compound suppressed growth of the cancer cell. The above compound can be serine palmitoyltransferase (SPT) inhibitors (abstract). Cancer can cause muscle disease too. The scope of claims 8-9 is inherently there since Kojima inhibit (SPT). On page 2457 disclose the sphingolipids include ceramide. Therefore, the instant claims are anticipated by Asano et al.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/
06/09/2026
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