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 .
This application is the national stage entry of PCT/US22/70209, filed 14 Jan 2022; and claims benefit of provisional application 63/137,720, filed 14 Jan 2021.
Claims 1-18 are pending in the current application. Claims 10-18, drawn to non-elected inventions, are withdrawn. Claims 1-9 are examined on the merits herein.
However, the parent provisional application 63/137,720 upon which priority is claimed fail to provide adequate support under 35 U.S.C. 112 for claims 4-7 of this application since the parent application is not seen to disclose the effective amount ratio ranges or amount ranges in claims 4-7. Written description for the single dosage amount of 1280 mg of D-ribose and 240 mg of nicotinamide in the investigational product RiaGev® may be found in at page 6, paragraph 29 of the specification of 63/137,720, however no support is found for the broader ratios or amounts claimed. The specification of 63/137,720 at page 3, paragraph 8 discusses Applicant's prior preclinical animal studies in WO2019/217935 incorporated-by-reference and further states “Based on these preclinical animal studies, Applicant developed an optimized ratio of nicotinamide (Nam) and D-ribose which is distributed under the trademark RiaGev® …” MPEP 608.01(p) at I.A.2. provides “An incorporation by reference of essential material to an unpublished U.S. patent application, a foreign application or patent, or to a publication is improper under 37 CFR 1.57(d). The improper incorporation by reference is not effective to incorporate the material unless corrected by the applicant (37 CFR 1.57(h)).” As WO2019/217935 is not a U.S. patent or U.S. patent application publication, it is improper to incorporate “essential material” necessary to provide a written description of the claimed invention. Further, the specification does not describe this invention having ratios other than this optimized ratio, or to amounts other than the investigational product RiaGev®.
Thus, the filing date of claims 4-7 is deemed to be the filing date of PCT/US22/70209, filed 14 Jan 2022. If applicant disagrees, applicant should present a detailed analysis as to why the claimed subject matter has clear support in the earlier priority applications. Applicant is reminded that such priority for the instant limitations requires written description and enablement under 35 U.S.C. § 112, first paragraph.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, in the reply filed on 02 Feb 2026 is acknowledged.
Claims 10-18 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 02 Feb 2026.
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 4-5 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 4-5 recite “the effective amount is a ratio” of nicotinamide to D-ribose of between 0.5:10 and 10:0.5 or between 1:5 and 5:1, respectively. However, the claims and the specification do not define how this ratio is determined. For example, the ratio might be a ratio by weight or by mole. Xue et al. (Clinical Protocol Cover Page, provided by Applicant in IDS filed 31 Dec 2024) discloses the investigating product RiaGev™ contains 1280 mg D-ribose, 240 mg Nicotinamide, and 480 mg Palm oil (Xue et al. page 20 of 52, section 8.3). D-ribose has a molecular weight of 150.13 g/mol, and nicotinamide has a molecular weight of 122.127 g/mol. As a ratio by weight this would be 5.33:1. As a ratio by mole this would be 4:34:1. It is unclear if the disclosure of Xue et al. falls within the scope of claim 5 because the ratio by weight 5.33:1 falls outside the range while the ratio by mole 4:34:1 falls within the range. Therefore the scope of claim 4-5 is indefinite because it is unclear how the ratio is defined.
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.
Claims 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bioenergy Life Science (NCT04483011, ClinicalTrials.gov, Last Update Posted 2020-11-25, cited in PTO-892) with evidence provided by Xue et al. (Clinical Protocol Cover Page, provided by Applicant in IDS filed 31 Dec 2024).
As detailed above, the filing date of claims 4-7 is deemed to be the filing date of PCT/US22/70209, filed 14 Jan 2022. Therefore Bioenergy Life Science, posted 25 Nov 2020, is published more than 1 year before the effective filing date of the claims.
Bioenergy Life Science discloses a study that investigates the efficacy and safety of RiaGev™ via evaluation of NAD+, ATP, glucose, insulin, glutathione, and cortisol levels in healthy adults (page 1, brief summary), or the NAD metabolome. The investigating product RiaGev™ contains Bioenergy Ribose® and vitamin B3 and increases NAD+ in the body efficiently. Bioenergy Ribose® is a 5-carbon carbohydrate (C5H10O5) called D-ribose. Vitamin B3 is an essential water-soluble vitamin known as either niacin, nicotinic acid, or nicotinamide (page 2, paragraphs 2-4), meaning the composition increases the NAD metabolome. The composition is administered 2000 mg BID (page 7, Study Plan), meeting limitations of claims 6-7. Xue et al. provides evidence that at the time of the Bioenergy Life Science disclosure RiaGev™ contains 1280 mg D-ribose, 240 mg Nicotinamide, and 480 mg Palm oil (Xue et al. page 20 of 52, section 8.3). D-ribose has a molecular weight of 150.13 g/mol, and nicotinamide has a molecular weight of 122.127 g/mol. As a ratio by mole this would be 4:34:1, meeting limitations of claims 4-5.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO’935 (WO 2019/217935 A1, published 14 Nov 2019, provided by Applicant in IDS filed 31 Dec 2024).
WO’935 discloses methods and compositions for increasing NAD levels in mammals by administering to the mammal an effective amount of D-ribose or D-ribose with Vitamin B3, where the Vitamin B3 may be niacin, nicotinamide, nicotinamide riboside or nicotinamide mononucleotide. The ratio between D-ribose and Vitamin B3 could vary between 0.5:10 and 10:0.5. The timing of administration to the mammal is at a time when the mammal is active or about to be active, whether the mammal is diurnal or nocturnal (abstract), meeting limitations of claim 4. WO’935 discloses the method wherein the effective amount is a ratio between 1:5 and 5:1 of Vitamin B3 to D-ribose (page 12, claim 3) meeting limitations of claims 4-5. WO’935 further discloses the working example 2 in which the combination of nicotinamide and D-ribose is administered at a ratio of 100:180 w/w (paragraph 26 spanning pages 5-6), meeting limitations of claims 4-5. WO’935 discloses the method wherein the effective amount is between 20 mg to 5400 mg per day or between 100 mg to 4000 mg per day (page 12, claims 4-5), meeting limitations of claims 6-7. WO’935 discloses the working example 3 of treating rats as test animals, in which the timing of the supplementation doses was chosen to mimic behavior in humans and other non-nocturnal mammals (i.e., diurnal mammals) of eating breakfast in the morning and dinner in the early evening by administering the doses to the animals at around those times (page 7, paragraph 35 to paragraph 36 spanning page 8), implying the method of treating human subjects meeting limitations of claim 1 and 8. Further, WO’935 discloses the working example 3 in which the Vitamin B3 in the combination is specifically nicotinamide (paragraph 37 spanning page 8-9), meeting limitations of claim 1.
Regarding claims 2-3, WO’935 does not specifically describe the results of the method “wherein NAD metabolome and glutathione levels are increased in the subjects” or “wherein NAD metabolome and glutathione levels are increased without causing redox unbalance in the subjects.” MPEP 2112.02 at II. provides “However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use.” In this case the prior art discloses the same compounds as well as a method of using them for increasing NAD levels in mammals such as humans but was silent as to the glutathione levels or redox unbalance in the subjects. Further, WO’935 at page 1, paragraph 2 discloses “as coenzymes, NAD+ and its related metabolites, NADH, NADP+, and NADPH, participate in over 60% of reactions in cellular metabolism, and their homeostasis is the determinant for oxidation versus reduction and anabolism versus catabolism balances.” This suggests the inventor of this application had merely found a new property of the compound and such a discovery did not constitute a new use.
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 indicating obviousness or nonobviousness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over WO’935 (WO 2019/217935 A1, published 14 Nov 2019, provided by Applicant in IDS filed 31 Dec 2024).
WO’935 teaches as above. WO’935 discloses the working example 3 of treating rats as test animals, in which the timing of the supplementation doses was chosen to mimic behavior in humans and other non-nocturnal mammals (i.e., diurnal mammals) of eating breakfast in the morning and dinner in the early evening by administering the doses to the animals at around those times (page 7, paragraph 35 to paragraph 36 spanning page 8). WO’935 further teaches in working experiment 2 Applicant determined that the exact dose scheme including optimal dose and timing needed to be refined in future experiments because the supplementation timing and sampling times seemed to play a big role in the experimental results (page 6, paragraph 29).
WO’935 does not specifically the effective amount is administered to the subjects immediately before the subjects eat breakfast in the morning and immediately before the subjects eat dinner in the evening (claim 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of WO’935 in order to select the optimal timing of the dose scheme. One of ordinary skill in the art would have been motivated to modify the teachings of WO’935 with a reasonable expectation of success because WO’935 teaches the timing of the supplementation doses was chosen to mimic behavior in humans of eating breakfast in the morning and dinner in the early evening by administering the doses to the animals at around those times, and further teaches the exact dose scheme including optimal dose and timing needed to be refined, suggesting it would have been obvious to one of ordinary skill in the art to determine the optimal timing of the doses given at around breakfast and dinner times, and therefore obvious to arrive at the method of administering to the subjects immediately before the subjects eat breakfast in the morning and immediately before the subjects eat dinner in the evening through routine experimentation.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN S LAU/ Primary Examiner, Art Unit 1693