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
The amendment filed on 6/09/2026 in response to the Non-Final rejection of 3/13/2026 is acknowledged . Claims 1, 5-7 and 11-12 are currently pending and under consideration.
Rejections withdrawn:
The rejection of Claims 9-10 and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-2, 6-8 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Xenical ® Label (1999-04) as evidenced by Ali et al. (Biochemistry 2006; 45: 14183-14191) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-3, 6-9 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Schweiger et al. (US9206115B2, 2015-12-08, IDS) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-4, 6-8, 10 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Mayer et al. (Nature Chemical Biology 2013; 9: 785-780, plus Supplemental) as evidenced by McKim and Strub (Pharmaceutical Technology 2008, 32 (5), 1-23) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 5 and 11 under 35 U.S.C. 103 as being unpatentable over Xenical ® Label (1999-04) as evidenced by Ali et al. (Biochemistry 2006; 45: 14183-14191) as applied to claims 1-2, 6-8 and 12 above, and further in view of Tanner and Alfieri (Viruses 2021; 13: 90) and Beigel et al. (N. Engl. J. Med. 2020; 383:1813-26) is withdrawn in view of Applicants amendments.
New Rejections Necessitated by Applicants amendments:
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1, 6-7 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schweiger et al. (US9206115B2, 2015-12-08, IDS).
Schweiger et al. teach compositions comprising one or more ATGL inhibiting agents (abstract). Specifically, Schweiger et al. teach a compound having the following structure
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referred to as compound 4, as well as, a pharmaceutical composition comprising said compound (claim 1 and 2 of the US Patent). Moreover, Schweiger et al. teach that atglistatin (cmpd 4) exhibits high selectivity for ATGL and does not interfere with other known secreted or intracellular lipases.
Schweiger et al. differs from the instant invention in that it does not teach that the methyl (one or both) on the urea have been replaced with an ethyl.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the either one or both of the methyl functional groups on the urea of the compound taught by Schweiger et al. for an ethyl, e.g. chain elongation or a homolog. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Accordingly, there is a reasonable expectation that a compound having one ore both methyl functional groups substituted with an ethyl group would also have high selectivity for ATGL.
Regarding the functional language in the preamble of claims 1 and 7, the Examiner directs Applicants attention to MPEP 211.02. In the instant case, the claims only require a lipase inhibitor. There does not appear to be any other structural limitations that are claimed which would not allow the prior art composition to function as presently claimed.
Conclusion
Claims 5 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
While ATGL has been shown to be involved and/or a target for Epstein-Barr virus at the time the invention was filed (see for example, Zheng et al. (Molecular Oncology 2020; 14: 3234-3252)), Epstein Barr virus is a DNA virus. At least remdesivir appears to be only active against RNA virus’s (see for example, Al-Ardhi et al. (Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2021; 165-XX)). Accordingly, there is no suggestion or motivation to combine an ATGL inhibitor with remdesivir for the treatment of Epstein-Barr virus.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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