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 .
Request for Continued Examination (RCE)
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/5/26 has been entered.
Priority
This application is a 371 of PCT/EP2021/060693 (04/23/2021)
PCT/EP2021/060693 is a CON of 15/930,154 (05/12/2020 ABN)
PCT/EP2021/060693 is a CON of 16/858,447 (04/24/2020 ABN)
and claims priority to EP 20171442.5 (04/25/2020).
Regarding the effective filing date, Applicant states in the 10/17/25 response:
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Status
Any rejections not reiterated in this action are withdrawn.
Claims 21, 25, and 30-34 are pending.
Claim Rejections - 35 USC § 102
Claims 21, 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huizenga et al. (WO2021202245, EFD 2020-04-02).
Huizenga is entitled “Viral Treatment Regimens” for “treating, preventing or reducing the ill effects of a viral infection in particular that of SARS-Co V-2, the compositions comprising a repair system activator including nicotinamide mononucleotide”. Huizenga teaches the composition is useful for treating viral infections including “influenza virus” (p. 3, lines 23-27, p. 4 line 28, p. 7 line 13, p. 104 Example 5, claims 17, 39, 53; 64004449 p. 81; 63005145 p. 84).
As disclosed by the instant specification, nicotinamide mononucleotide (NMN) was known and corresponds to instant formula I-A having the following structure ([0018], [0596]):
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Huizenga teaches NMN administered to a subject (p. 66-84, p. 85, Example 1, claim 1). NMN corresponds to dependent claim 10’s Formula I-A and thus anticipates the claims and claim 1’s Formula (I) where X is O; Y is CH2; R1,3,4,6 are H; R2,5 are OH; R7 is P(O)(OH)2; R8 is NH2.
Regarding the EFD and support for Huizenga, in the priority document, 63/004449 (filed 2020-04-02), the title is the same, the abstract states “treating, preventing, and/or reducing the ill effects of a viral infection in a subject in need thereof” including referring to influenza. Thus, there is sufficient support in Huizenga.
Claims 21, 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thompson (AU 2020100400, pub date 2020-04-23).
Thompson teaches administering NMN for treating viral infections, including flu
(claims 1-3), wherein the NMN corresponds to instant Formula Ia-A.
Response to Remarks - 35 USC § 102
Applicant argues that Huizenga priority documents do not teach treating influenza virus. This is not persuasive as detailed in the amended rejection above.
Claim Rejections - 35 USC § 103
Claims 21, 30, 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al. (WO2021202245, EFD 2020-04-02) in view of Thompson (AU 2020100400, pub date 2020-04-23).
Huizenga and Thompson teach as detailed in the 35 USC 102 rejection supra and incorporated herein. Regarding claims 21, 30, Huizenga and Thompson also render these claims obvious as anticipation is the epitome of obviousness. "[A] disclosure that anticipates under § 102 also renders the claim invalid under § 103, for `anticipation is the epitome of obviousness.'" Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548, 220 USPQ 193, 198 (Fed.Cir.1983) (citing In re Fracalossi, 681 F.2d 792, 215 USPQ 569 (CCPA 1982)).
Regarding claims 33-34 specifying a dose and reducing viral load, Huizenga teaches an amount that would be equivalent to the instant claims (‘449 p. 54: “The dosages can also be at least 2.38 moles/kg per day.”; NMN (MW=334.22) : 334.22g/mol x 2.38 mol/kg/day = 795 mg/kg body weight/day). One of ordinary skill in the art following the teaching of Huizenga and Thompson would consider routine the optimization of dosing to maximize therapeutic effect which is a well-known results effective variable. One of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success, particularly in view of Huizenga’s teaching of an equivalent dose. Furthermore, reducing the viral load would be the inherent result from administering the therapeutic.
Claims 25 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al. (WO2021202245, EFD 2020-04-02) in view of Thompson (AU 2020100400, pub date 2020-04-23) as applied to 21, 30, 33-34 above and further in view of Li et al. (Cell. Mol. Life Sci. (2015) 72:2973–2988).
Regarding claims 25 specifying the viral infection is influenza, including type H1N1, although Huizenga teaches treating viral infections by administration of repair system activators, Huizenga does not specifically teach the same virus as in the claim.
Li teaches influenza, including H1N1, cause DNA damage addressed by mechanisms of repair systems (p. 2974). One of ordinary skill in the art following the teaching of Huizenga would have considered Li’s teaching of H1N1 damage and applied the same therapeutic for the same purpose in the context of H1N1 and arrive at the claimed invention with a reasonable expectation of success.
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al. (WO2021202245, EFD 2020-04-02) ) in view of Thompson (AU 2020100400, pub date 2020-04-23) as applied to 21, 30, 33-34 and further in view of Nguyen et al. (Antimicrobial Agents and Chemotherapy, Oct. 2009, 53:10, p. 4115–4126).
Regarding claims 31-32 specifying a combination with oseltamivir, Huizenga does not teach the combination.
Nguyen teaches oseltamivir combinations to treat viral infections with synergistic results on viral strains including H1N1 (p. 4115). Once of ordinary skill in the art would have considered combining known antiviral therapeutics with an expectation of success. “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).
Response to Remarks - 35 USC § 103
Applicant argues similarly with respect to Huizenga as with the 35 USC 102 rejection. The argument is not persuasive as detailed above.
Applicant argues that the combined teaching with Li and Nguyen does not suggest treating an influenzavirus as claimed. This argument is not persuasive as the level of skill in the art is very high as evidenced by each of the cited references such that one of ordinary skill in the art would have considered the combined teaching as reasonably suggesting the use of NMN with H1N1 influenza and arrive at the claimed invention.
Double Patenting Rejections
Claims 21, 25, and 30-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No 17785631 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 26 is to the following species I-A:
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and claim 18-27 and 29 are to compositions whose disclosed utility includes treating viral infections, thus one of skill in the art construing the claim would arrive at the claimed invention, particularly in view of the disclosed utility at [0231] of treating influenza virus. See MPEP 804, Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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