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 1-8, 10-13 and 17-22 are pending. Claims 4-8 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, Therefore, Claims 1-3, 10-12 and 17-22 are under examination.
Election/Restrictions
Applicant elected without traverse chemically synthetized trigonelline in the reply filed on 3/21/2025.
Claims 4-8 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
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Withdrawn Rejection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 1-3, 10-12 and 17 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 and 11 of U.S. Patent No. 11,758,928 B2. Applicant’s amendment and corresponding reply pertaining to the newly added limitation have overcome the ODP rejection made of record in the previous Office Action, specifically, the addition of the chemically synthetized trigonelline limitation. Therefore, the rejection is hereby withdrawn.
Claim Objections
Claims 21-22 are objected to because of the following informalities:
Applicant is advised that should claim 20 be found allowable, claims 21 and 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a composition consisting essentially of chemically synthesized trigonelline comprising at least about 90% (or 98%) trigonelline. Trigonelline is a naturally occurring compound found in plant and algae sources, for example, an extract from one or more of coffee bean (e.g., a green coffee extract), Japanese radish, fenugreek seed, garden pea, hemp seed, oats, potato, and dahlia. See 0073 of Specification. The claimed composition encompasses trigonelline that is structurally identical to naturally occurring trigonelline.
The judicial exception is a natural phenomenon, namely the naturally occurring chemical compound, trigonelline. Although the claims recite “chemically synthesized” trigonelline, they do not require any structural modification or alteration of the molecule. The claims encompass trigonelline having the same structure and properties as naturally occurring trigonelline. Merely synthesizing a naturally occurring compound does not render it markedly different from the natural product.
This judicial exception is not integrated into a practical application because the claims do not recite additional elements that impose a meaningful limitation on the natural product. The claims do not require a structural modification, a specific pharmaceutical formulation, or any functional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recitation of chemical synthesis describes a method of preparation and does not alter the structure of the compound itself. The purity limitation represents routine isolation and purification of a natural compound. Accordingly, the claims fail to add an inventive concept beyond that natural phenomenon and are not patent-eligible.
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 1-3, 10-12, and 17-22 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
Claim 1 is drawn to a composition consisting essentially of chemically synthesized trigonelline comprising at least about 90% trigonelline.
Claim interpretation
As used in the specification, a “composition consisting essentially of trigonelline” is described to contain trigonelline and is substantially free or completely free of any additional compound that affects NAD+ production other than the trigonelline. See 0076. As used herein, “substantially free” means that any of the other compounds present in the composition is no greater than 1.0 wt.% relative to the amount of trigonelline. See 0082. The claim recites “of chemically synthesized trigonelline comprising at least about 90% trigonelline”. It is interpreted such that the chemically synthesized trigonelline comprising at least about 90% trigonelline. Thus, if the prior art teaches synthesized trigonelline and no other NAD+-modulating actives greater than 1.0 wt.% as part of the trigonelline, then it would meet the claimed composition. In other words, if chemically synthesized trigonelline is described, then the chemically synthesized trigonelline would inherently comprising at least about 90% trigonelline because it is by definition trigonelline itself and nothing else.
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. 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 90% trigonelline”.
Claim 2 limits from Claim 1, wherein the composition is formulated for enteral administration. Claim 3 limits Claim 1, 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 11, Claim 12, Claim 18 and Claim 19.
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. 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. 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.
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,
(iv) treatment or prevention of muscle fatigue,
(v) improved mobility 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. DSM teaches trigonelline increase muscle weight during a training period, and reduces muscle loss during periods of lesser activity or immobility. See 0006. Thus, DSM teaches the method of the invention reduces, inter alia, improve mobility as claimed.
Claims 20-22 limits Claim 1, 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 the amended claims because DSM allegedly fails to disclose that the chemically synthesized trigonelline contains “at least about 90% trigonelline,” asserting that the chemically synthesized trigonelline not necessarily 100% pure. Applicant's arguments have been fully considered but have not been found to be persuasive. Applicant’s argument relies on an unsupported assumption that synthesized trigonelline in DSM would necessarily fall outside the claimed range. Given that trigonelline is synthesized by DSM as the active compound, and given that trigonelline is 100% itself, the claimed trigonelline range of “at least 98% trigonelline” is met.
Therefore, the rejection is deemed to still be proper and is, therefore, maintained.
Conclusion
No claims are allowed.
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.
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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