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 claim set filed on 12/20/2023 is acknowledged. Claims 1-12 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed on 12/20/2023 is acknowledged and has been considered except where lined through.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10 and 12 are rejected 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.
Claim 9 recites the limitation "the ATGL inhibitor". There is insufficient antecedent basis for this limitation in the claim in claim 7 which recites generically “a lipase inhibitor”.
Claim 10 recites the limitation "the derivative". There is insufficient antecedent basis for this limitation in the claim in claim 7 which recites generically “a lipase inhibitor”.
Claim 12 recites the limitation "the RNA virus". There is insufficient antecedent basis for this limitation in the claim in claim 7 which recites generically “an antiviral composition”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-8 and 12 is/are rejected 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).
Xenical ® label teaches a pharmaceutical composition comprising XENICAL (also referred to as orlistat) for oral administration in hard-gelatin capsules, wherein each capsule contains 120 mg of active agent (Description, 4th paragraph). While Xenical ® label does not specifically teach that Xenical is a hormone-sensitive lipase inhibitor, as evidenced by Ali et al., THL (also referred to as Orlistat) reduced the activities of HSL (hormone-sensitive lipase), EST2, AFEST, PLEst, and LipA by 90-95% (p. 14186, 2nd column, 2nd full paragraph). Regarding the preambles/intended uses of both claims 1 and 7, the Examiner directs Applicants attention to MPEP 2111.02
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
In the instant case, the claims only require the lipase inhibitor. There are no other structural limitations that are claimed which would not allow the prior art composition to function as presented claimed.
Claim(s) 1-3, 6-9 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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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which appears to be identical to the compound named in claim 3, as well as, a pharmaceutical composition comprising said compound (claim 1 and 2 of the US Patent). Regarding the preambles/intended uses of both claims 1 and 7, the Examiner directs Applicants attention to MPEP 2111.02
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
In the instant case, the claims only require the lipase inhibitor. There are no other structural limitations that are claimed which would not allow the prior art composition to function as presented claimed.
Claim(s) 1-4, 6-8, 10 and 12 is/are rejected 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).
Mayer et al. teach a compound having the formula
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which is identical to the morpholino derivative claimed in claim 4 and 10 of the instant application (S-22). Moreover, Mayer et al. teach that the compound was dissolved in DMSO (S-12, Supplemental Fig. 8. Note: DMSO is recognized as a pharmaceutically acceptable carrier/excipient as evidenced by McKim and Strub. Regarding the preambles/intended uses of both claims 1 and 7, the Examiner directs Applicants attention to MPEP 2111.02
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
In the instant case, the claims only require the lipase inhibitor. There are no other structural limitations that are claimed which would not allow the prior art composition to function as presented claimed.
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.
Claim(s) 5 and 11 is/are rejected 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).
Xenical ® label teaches a pharmaceutical composition comprising XENICAL (also referred to as orlistat) for oral administration in hard-gelatin capsules, wherein each capsule contains 120 mg of active agent (Description, 4th paragraph).
Xenical ® label does not teach that the composition further comprises remdesivir.
Tanner and Alfieri teach that approved medicines such as orlistat and metformin that act respectively on FASN and AMPK, and which are expected to inhibit virus replication and assembly or to promote gastrointestinal integrity and decrease deleterious systemic inflammation, merit serious consideration for clinical testing as anti-COVID-19 therapies (page 11 of 18, Conclusions and Future directions).
Beigel et al. presents data showing that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had a lower respiratory tract infection (page 1813, Conclusions).
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 modify the pharmaceutical composition of Xenical ® label comprising orlistat so as to include remdesivir in view of the teachings of Tanner and Alfieri and Beigel et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-each of the compounds have been individually taught or suggested as a treatment for COVID-19 patients.
Moreover, "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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) .
Conclusion
Therefore, No claim is allowed.
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