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 .
CONTINUING DATA
This application is a 371 of PCT/EP2022/067412 06/24/2022
FOREIGN APPLICATIONS
UNITED KINGDOM 2109138.4 06/24/2021
UNITED KINGDOM 2200883.3 01/24/2022
GREECE 20220100277 03/29/2022
Applicant’s amendment and election without traverse of Group I, claims 1, 2, 10, 22, 26, 29-32, 37-41, and 44-45 in the reply filed on July 7, 2026 is acknowledged.
Claims 48-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 7, 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 29-32, 37, 40-41, and 44 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 29-32 and 37 depend from claim 1, and require that NR is administered in combination with other agents. Claim 1, however, requires that NR is given as a monotherapy. Thus, claims 29-32 and 37 do not require all the limitations of the claim upon which they depend. Claims 40 and 41 and 44 depend from claim 1 and recite that the NR is NR chloride or is a salt, solvate, or hydrate thereof. Claim 1 does not encompass salts, solvates, and hydrates, so claims 40-41 do not include all the limitations of the claim upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 29-32 and 37 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.
Claims 29-32 and 37 are drawn to a method comprising administering NR in combination with other agents. The claims depend from claim 1, which requires administering NR as a monotherapy. The claims are unclear because administration cannot be both a monotherapy and a combination therapy at one time.
Claim 37 recites that NR is administered as a monotherapy or as a monotherapy in combination with a dopaminergic agent plus MAO-B inhibitor. It is unclear what is meant by monotherapy in combination with a dopaminergic agent plus MAO-B inhibitor, because if the NR is given with other agents, it is not a monotherapy.
It is impossible to apply prior art to claims 29-32 and 37 because no prior art can meet the limitation of administration as a monotherapy and a combination therapy at one time. For the purpose of applying prior art, claims 29-32 and 37 will be interpreted to require combination therapy and not monotherapy.
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, 10, 22, 26, 37-39, 41, 44-45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marcotulli (WO 2018/039207 A1, cited on IDS).
Marcotulli teaches a method of treating PD in a subject comprising administering nicotinamide riboside. Claim 8. The composition may contain 150 mg, 250 mg, or 300 mg of NR. Claims 16-19. Administration is orally by pill, tablet or capsule (claims 59-60). Doses are administered twice a day (claim 53) for at least six months (claim 58). Administration treats or reduces the risk or prevalence of neurodegenerative disease, including Lew bodies, freezing of gait, or dementia (claim 12). NR can be in the form of a salt with an inorganic or organic counterion such as formic. Page 22.
The limitations of claims 10 and 22 are inherent in the administration of NR to the PD patient at the claimed dose. A composition and its properties are inseparable, and Marcotulli teaches the administration of the same drug (NR) to the same patient (PD) at the claimed doses (as low as 200 mg per day).
Claim(s) 1-2, 10, 22, 26, 37, 41, 44-45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT03816020, February 12, 2020, cited on IDS.
NCT03816020 teaches treatment of individuals with PD (only newly dosed and drug naïve) using nicotinamide riboside (NR) 500 mg x 2/day for 4 weeks. NR will be administered as capsules 250 mg x 2BID. Pages 2-3.
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.
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) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcotulli (WO 2018/039207 A1, cited on IDS) in view of Mehmel (Nutrients 2020, 12, 1616, cited on IDS).
Marcotulli teaches administration of a NR salt as set forth above, but does not teach that the NR salt is NR chloride.
Mehmel teaches that NR chloride has been given GRAS status (page 4, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer NR chloride for treatment of PD because NR chloride has GRAS status and is known to be safe.
Claim(s) 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcotulli (WO 2018/039207 A1, cited on IDS).
Marcotulli teaches a method of treating PD in a subject comprising administering nicotinamide riboside and pterostilbene (a MAO-B inhibitor). Claim 9. Parkinson’s disease is also treated using Levodopa (a dopaminergic agent). See page 1, Background.
Marcotulli does not teach treatment of PD using NR, pterostilbene, and Levodopa.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify Marcotulli’s method to include administration of Levodopa along with NR and pterostilbene because they are all used for the same purpose (treating PD). See MPEP 2144.06. “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.”
Claim(s) 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcotulli (WO 2018/039207 A1, cited on IDS) in view of Elizan (Arch Neurol-Vol 48, January 1991).
Marcotulli teaches a method of treating PD in a subject comprising administering nicotinamide riboside. Claim 8. The composition may contain 150 mg, 250 mg, or 300 mg of NR. Claims 16-19. Administration is orally by pill, tablet or capsule (claims 59-60). Doses are administered twice a day (claim 53) for at least six months (claim 58).
Marcotulli does not teach administration of NR along with a dopaminergic agent plus MAO-B inhibitor.
Elizan teaches that PD patients are treated using selegiline and Sinemet (carbidopa pluse levodopa). See abstract. The dose of selegiline was 10 mg, the dose of carbidopa was 98 mg, and the dose of levodopa was 389 mg. See Table 1.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify Marcotulli’s method to include administration of selegiline plus Sinemet because NR and selegiline plus Sinemet are all used for the same purpose (treating PD). See MPEP 2144.06. “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.”
Double Patenting
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 1-2, 10, 22, 26, 29-32, 37-41, and 44-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 17-18, 20, 24, 28, 41, 43, 50, 59-60, 63, 67, 69, 85-86, 97, 100 of copending Application No. 18858964 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims treatment of PD using NR (claims 1 and 18). The dose is preferably 1000 mg daily for 16 weeks (claim 2). The method results in an increase of cerebral NAD levels (claim 5). The method improves motor symptoms (claim 24). The subject is newly diagnosed with PD (claim 43). Administration is oral (claim 59). NR is administered as a monotherapy or in combination with a dopaminergic agent plus MAO-B inhibitor (claim 60). Claim 63 of the reference application recites the same doses recited in current claim 32, including administration of selegiline and levodopa. Treatment is at least 2 or at least 12 months (claim 65). NR is a salt such as chloride (claim 69). An oral capsule is claimed (claim 100). The reference claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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