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 .
Status
Claims 10-12, 17-19, and 21-22 are pending and under examination.
Election/Restrictions
Applicant elected without traverse chemically synthetized trigonelline in the reply filed on 3/21/2025.
Priority
The present application is a National Stage of International Application No. PCT/EP2020/068786, filed on July 3, 2020, which claims priority to U.S. Provisional Patent Application No. 62/870,988, filed on July 5, 2019.
Information Disclosure Statement
No Information Disclosure Statement was filed with Applicant’s remarks.
Withdrawn Rejection
Claims 21 and 22 were rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Applicant’s amendment and corresponding reply pertaining to the newly added limitation have overcome the 35 U.S.C. 101 rejection made of record in the previous Office Action, specifically, the change of the claim from a product claim to a method claim.
Claim Rejections - 35 USC § 102
Maintained
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 10-12, 17-19, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DSM IP Assets BV (EP2269607A1 – “DSM”, published January 5, 2011).
Claimed invention
Independent Claim 10 is drawn to a method for increasing intracellular nicotinamide adenine dinucleotide (NAD+) in a mammal, the method comprising administering a composition comprising essentially of trigonelline to a mammal in need of same an amount effective to increase NAD+ biosynthesis in one or more cells of the mammal.
Independent Claim 17 is drawn to a method of achieving in an individual in need of at least one result selected from the group consisting of
(i) increased mitochondrial energy in one or more cells,
(ii) improvement in a physiological state linked to metabolic fatigue in one or more cells,
(iii) treatment or prevention of metabolic fatigue in one or more cells, and
(vi) improved longevity,
the method comprising orally administering to an individual in need of same a composition comprising trigonelline in an amount effective to increase NAD+ biosynthesis.
Prior art
DSM teaches compositions containing trigonelline and does not teach the required presence of any other compound that modulates NAD+. See title; abstract. The trigonelline is formulated into a nutraceutically acceptable form, or into a foodstuff. See 0009. It is synthetically made. See 0012. Because trigonelline is 100% of itself, the teaching of trigonelline meets the limitation that it is “at least 90% trigonelline”.
DSM teaches the composition containing trigonelline is used to increase muscle weight during periods of activity or to inhibit muscle loss during periods of inactivity. See abstract; 0006. While dosages may vary, they may range from at least 5 mg per day for a human; preferably from 5 to 5,000 mg/day for a human, more preferably from 10 to 3000 mg/day for a human and even more preferably from 50-500 mg/day for a human. See 0018. Animals were treated for three weeks by gavage with trigonelline hydrochloride at a daily dosage of 300 mg/kg body weight. See 0041. Thus, the animals were administered an amount effective to increase NAD+ biosynthesis in one or more cells of the mammal because it meets the amounts disclosed as being effective for same. See Specification, at 0068, 0070 and Figure 3; see also working examples at 00114, particularly Example 5 at 00121 and Figure 5. Administration of trigonelline at such an effective amount consequently achieves at least increased mitochondrial energy in one or more cells, thereby meeting at least (i) of Claim 17.
Regarding Claim 11, wherein the composition is formulated for enteral administration and Claim 12, wherein the composition is selected from the group consisting of a food product, a food supplement, an oral nutritional supplement (ONS), a medical food, and combinations thereof, DSM teaches animals were treated for three weeks by gavage (i.e., enteral feeding) with composition containing trigonelline. See Example 3 at 0033-0038. Preferred compositions comprise trigonelline or a salt or ester thereof and a suitable dietary, nutraceutical or pharmaceutical carrier. See 0009,0019. This also meets Claim 18 and Claim 19.
Regarding Claim 21 and Claim 22, wherein trigonelline is chemically synthesized trigonelline is comprises at least about 98% trigonelline, DSM teaches trigonelline is synthetically made. See 0012. Because trigonelline is 100% of itself, the teaching of trigonelline meets the limitation that it is “at least 98% trigonelline”.
Response to arguments
Applicant argues that DSM does not anticipate Claim 17 because DSM does not expressly disclose increasing NAD+ biosynthesis or the recited results. This argument is not persuasive. Anticipation does not require the reference to expressly recognize or describe a result that necessarily results from the administration of the effective amounts described in the reference. DSM discloses oral administration of trigonelline, including amounts falling within those disclosed by Applicant as effective to increase NAD+ biosynthesis. See DSM 0018,0041.; Specification 0068, 0070, 0114, 0121 and Figs. 3 and 5. Thus, DS’s administration necessarily increases NAD+ biosynthesis and achieves the associated claimed result, including increased mitochondrial energy in one or more cells. The fact that DSM describes the treatment in terms of increased muscle weight, prevention of muscle loss, and improved mobility rather than NAD+ biosynthesis or mitochondrial energy does not distinguish the claimed method where the same administration produces the claimed effects.
Therefore, the rejection is deemed to still be proper and is, therefore, maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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, James H. Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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