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 .
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Any rejections not reiterated in this action are withdrawn.
Applicant presented new claims 21-39 and cancelled all other claims.
New Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-23, 26-27, 29-30 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”.
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 ... In embodiments, the viral infection is caused by SARS-COV-2”, and p. 79-80 is disclosed Example 1:
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which would also anticipate the claims. Thus, there is sufficient support in Huizenga.
Claims 21-22, 26, 28-30, 35-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Szczepankiewicz et al. (US10618927, pub date 2020-04-14).
Szczepankiewicz teaches pharmaceutical compositions comprising the compound:
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(col 18; Fig. 1A) administered for the treatment of viral infections (col 11, lines 61-65: “Viral infections such as herpes, HIV, adenovirus, and HTLV-1”), wherein the compound corresponds to instant Formula Ia-A.
New Claim Rejections - 35 USC § 103
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.
Claims 21-23, 26-27, 29-30, 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al. (WO2021202245, EFD 2020-04-02).
Huizenga teaches as detailed in the 35 USC 102 rejection supra and incorporated herein. Regarding claims 21-23, 26-27, 29-30, Huizenga also renders 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 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 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al. (WO2021202245, EFD 2020-04-02) as applied to 21-23, 26-27, 29-30, 33-34 above and further in view of Li et al. (Cell. Mol. Life Sci. (2015) 72:2973–2988).
Regarding claims 24-25 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) as applied to 21-23, 26-27, 29-30, 33-34 above 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).
Claims 21-22, 26, 28-30, 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Szczepankiewicz et al. (US10618927, pub date 2020-04-14).
Szczepankiewicz teaches as detailed in the 35 USC 102 rejection supra and incorporated herein. Regarding claims 21-22, 26, 28-30, 35-38, Szczepankiewicz also renders 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)).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Szczepankiewicz et al. (US10618927, pub date 2020-04-14) as applied to 21-22, 26, 28-30, 35-38 above and further in view of Li et al. (Cell. Mol. Life Sci. (2015) 72:2973–2988).
Regarding claims 23-25 specifying the viral infection is influenza, including type H1N1, although Szczepankiewicz teaches treating viral infections (col 11, lines 61-65: “Viral infections such as herpes, HIV, adenovirus, and HTLV-1”) and the mechanism of infections involves DNA repair (col 1), but 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 Szczepankiewicz 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.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Szczepankiewicz et al. (US10618927, pub date 2020-04-14) as applied to 21-22, 26, 28-30, 35-38 above 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, Szczepankiewicz 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).
New Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-39 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. 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.
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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey 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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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626