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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026 has been entered.
DETAILED ACTION
The rejection of claim 6 is withdrawn in light of the cancelation of the claim in the amendment filed 3/23/2026.
Claims 1-5 and 7-8 are pending and under examination herein.
Priority
This application is a 371 of PCT/JP2021/004912 filed on 2/10/2021, which claims priority to JAPAN 2020-058429 filed 3/27/2020. A certified English Translation was provided on March 22, 2026. The effective filing date for prior art purposes is March 27, 2020.
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 1-5 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product, naturally occurring β-nicotinamide mononucleotide, without significantly more.
Claims 1-5 recite an embodiment that is a supplement comprising: β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof, wherein the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof has a bioavailability based on a purity of 95% or higher when measured by HPLC, and a reactivity thereof with lactate dehydrogenase of 30 units or higher; and wherein the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof is substantially free from nicotinamide dinucleotide. The wherein clause regarding the purity and reactivity of the compound does not distinguish the chemical structure of purified β-nicotinamide mononucleotide from naturally occurring β-nicotinamide mononucleotide. Claim 7 recites a method of producing a supplement comprising crystallizing the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof, measuring the purities of the plurality of β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof and measuring reactivities with lactate dehydrogenase of the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof, and recovering the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof in crystalline form and producing a supplement.
Poddar et al. (“Nicotinamide Mononucleotide: Exploration of Diverse Therapeutic Applications of a Potential Molecule”, Biomolecules, 2019, Vol. 9, Issue 1, article 34, 15 pages; previously cited) identifies that nicotinamide mononucleotide (NMN) is a bioactive nucleotide naturally formed by the reaction between a phosphate group and a nucleoside containing ribose and nicotinamide (p.1, 1st paragraph). Poddar further states that NMN exists in two anomeric forms, alpha and beta, with the beta anomer being the active form between the two (p.1, introduction - 1st paragraph). Poddar states that NMN is naturally abundant in various types of food, like broccoli, cabbage, fruits like avocado and tomato, and raw beef (p.1, introduction - 1st paragraph).
Carr et al. (US 2018/0282361 A1, published October 4, 2018; previously cited) teaches that purity analysis was performed on an Agilent HP1100 series system equipped with a diode array detector and using ChemStation software vB.04.03 using the method detailed below in Table 1 (description p.18, [0206]; Table 1). Carr further teaches that the purity of the material after 12 weeks was determined as 67.5% (replicate 2) and the nicotinamide abundance was 20.6% (description p.19, [0216]). Carr also teaches that crystalline form 1 remained chemically pure (~99.3%) after 4 weeks of storage at all the tested conditions (description p.19, [0217]).
McPherson (“Interaction of Lactate Dehydrogenase with is Coenzyme, Nicotinamide-Adenine Dinucleotide”, Journal of Molecular Biology, 1970, Vol. 51, Issue 1, pp.39-46; previously cited) teaches that assays for lactate dehydrogenase activity in the presence and absence of inhibitor were based on the increase of absorption at 340nm caused by the production of NADH during the oxidation of lactate to pyruvate (p.40, 1st paragraph). McPherson teaches that nicotinamide mononucleotide can bind to the lactate dehydrogenase-AMP complex (p.45, 3rd paragraph).
The specification discloses that β-nicotinamide mononucleotide may be prepared by any method, for example artificially synthesized by a chemical synthesis method, an enzymatic method, or a fermentation method followed by purification can be used as an active ingredient (Spec p.8, lines 2-7). The specification further discloses that this compound, which is an ingredient that is ubiquitously present in living bodies, can be obtained through extraction and/or purification from natural materials such as animals, plants, and microorganisms (Spec p.8, lines 7-10).
This judicial exception is not integrated into a practical application because the claims are simply drawn to a supplement comprising β-nicotinamide mononucleotide. Since the facts indicate that the compound is naturally occurring and can be isolated from natural materials such as animals, plants and microorganisms, the claimed supplement composition does not possess any markedly different characteristics from its naturally occurring counterpart. There are no additional elements recited that would integrate the judicial exception into a practical application or add significantly more.
The recitation in claim 1 of a purity of 95% or higher, and a reactivity thereof with lactate dehydrogenase is 30 units or higher are not markedly different characteristics that change the structure of the β-nicotinamide mononucleotide relative to the naturally occurring compound β-nicotinamide mononucleotide. The recitation in claim 1 of the β-nicotinamide mononucleotide being substantially free of nicotinamide dinucleotide is not a markedly different characteristic that changes the structure of the β-nicotinamide mononucleotide relative to the naturally occurring compound β-nicotinamide mononucleotide.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim recites a method of selecting β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof that has high bioavailability, comprising measuring a purity of β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof to determine the purity is 95% or higher when measured through HPLC; and measuring a reactivity of the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof with lactate dehydrogenase ex vivo to determine the reactivity being 30 units or higher. Thus, the claim is directed to a process (Step 1: Yes).
The claim sets forth a judicial exception which is an abstract idea (mental step). Claim 8 recites a step of selecting a β-nicotinamide mononucleotide solution that has 95% or higher purity, and has the reactivity of 30 units or higher, which is a mental step (Step 2A Prong 1: Yes).
This judicial exception of a mental step is not integrated into a practical application (Step 2A Prong 2: No). There are no additional elements recited in the method (Step 2B: No). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations do not impose any meaningful limits on practicing the abstract idea.
Carr et al. (US 2018/0282361 A1, published October 4, 2018; previously cited) teaches that purity analysis was performed on an Agilent HP1100 series system equipped with a diode array detector and using ChemStation software vB.04.03 using the method detailed below in Table 1 (description p.18, [0206]; Table 1). Carr further teaches that the purity of the material after 12 weeks was determined as 67.5% (replicate 2) and the nicotinamide abundance was 20.6% (description p.19, [0216]). Carr also teaches that crystalline form 1 remained chemically pure (~99.3%) after 4 weeks of storage at all the tested conditions (description p.19, [0217]).
McPherson (“Interaction of Lactate Dehydrogenase with is Coenzyme, Nicotinamide-Adenine Dinucleotide”, Journal of Molecular Biology, 1970, Vol. 51, Issue 1, pp.39-46; previously cited) teaches that assays for lactate dehydrogenase activity in the presence and absence of inhibitor were based on the increase of absorption at 340nm caused by the production of NADH during the oxidation of lactate to pyruvate (p.40, 1st paragraph). McPherson teaches that nicotinamide mononucleotide can bind to the lactate dehydrogenase-AMP complex (p.45, 3rd paragraph).
The selection a β-nicotinamide mononucleotide solution that has a purity of 95% or higher and a reactivity of 30 units or higher based on a measurement is a mental step.
Thus, claims 1-5 and 7-8 are rejected under 35 U.S.C. §101.
Response to Arguments
Applicant summarizes the rejection of claims 1-6 and recites the limitations of claim 1 (See Remarks dated 3/23/2026, p.1, last 2 paragraphs). Applicant argues that nicotinamide dinucleotide (NAD) is a metabolite of β-NMN in nature, and β-MNM that is substantially free of NAD is not a naturally occurring product (See Remarks dated 3/23/2026, p.6 1st paragraph). Applicant refers to three applicant-supplied references [Shabalin et al.; Grozio et al.; and Berger et al.] as evidence that NMN is easily metabolized to NAD in vivo, and NAD co-exists with β-NMN in nature (See Remarks dated 3/23/2026, p.6 1st paragraph). Applicant further argues that there is no reasonable basis to expect that β-NMN in a natural product is substantially free from NAD, and therefore the pharmaceutical composition, food, drink, supplement or feed of claim 1 comprising the β-NMN or a pharmacologically acceptable salt is not a product of nature and should not be subject to this rejection (See Remarks dated 3/23/2026, p.6 2nd paragraph).
Regarding claim 8, Applicant argues that rejection alleges measuring the purity and reactivity of β-NMN is a mental process, and applicant disagrees (See Remarks dated 3/23/2026, p.7, top paragraph). Applicant argues the method of claim 8 includes procedures, and the recited processes cannot be carried out in the human mind (See Remarks dated 3/23/2026, p.7, 1st full paragraph). Applicant argues that the claimed method should be determined patent eligible as it integrates the alleged mental step into a practical application such as using HPLC and determining reactivity with a lactate dehydrogenase; and further, the obtained product, a β-NMN that has high bioavailability and is substantially free of NAD, is not a product of nature as discussed above (See Remarks dated 3/23/2026, p.7, 2nd paragraph).
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive. Regarding claims 1-5: The instant claims are directed towards various alternative embodiments including a supplement that can comprise β-NMN alone. The rejection is directed towards the embodiment of a supplement comprising β-NMN, which would not have any markedly different structural characteristics compared to β-NMN isolated from natural sources.
Although β-NMN may co-exist with its metabolite NAD, β-NMN independently is as a known molecule that is found in nature, and the structure of β-NMN is known in the art, as discussed in the rejection above. Although Applicant’s references identify that β-NMN and NAD are detectable in vivo, β-NMN itself does exist as a separate molecule, and when isolated, would be structurally identical to the structure of β-NMN found in nature.
Regarding claim 8 – the mental steps referred to were the previously recited “determining” steps which relied upon measuring β-NMN purity and measuring the reactivity of β-NMN with lactate dehydrogenase; “determining the purity being 95% or higher” and “determine the reactivity being 30 units or higher”. The steps of preparing a solution of β-NMN, measuring purity using HPLC, and determining a reactivity ex vivo are well-known, routine and conventional steps known in the art as disclosed by Carr et al. and McPherson. The selection of β-NMN based upon particular purity and reactivity criteria is a mental step, which can be performed in the human mind, and the claim does not incorporate any additional elements that overcome the judicial exception.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being clearly anticipated by Carr et al. (US 2018/0282361 A1, published October 4, 2018; previously cited) as evidenced by McPherson (“Interaction of Lactate Dehydrogenase with is Coenzyme, Nicotinamide-Adenine Dinucleotide”, Journal of Molecular Biology, 1970, Vol. 51, Issue 1, pp.39-46; previously cited) and NMN Nicotinamide Mononucleotide from BulkSupplements.com (https://www.bulksupplements.com/products/nicotinamide-mononucleotide-nmn; previously cited).
Regarding claim 1, the limitation identifying the reactivity of the compound with lactate dehydrogenase as being “30 units or higher” is being interpreted as a desired result based on a property of the compound, but does not materially distinguish the chemical structure of the required pharmaceutical composition comprising β-nicotinamide mononucleotide.
Carr teaches amorphous beta nicotinamide mononucleotide was weighed into a glass vial with deionized water to form a clear solution, which was stirred and then mixed with methanol to produce a white solid which was isolated and dried to provide crystalline beta nicotinamide mononucleotide form 1 (p.18, 1st column, [0208] Example 1). Carr teaches that crystalline form 1 remained unchanged in terms of solid form and particle morphology at all conditions tested, remaining chemically pure (~99.3%) after 4 weeks of storage at all the tested conditions as tested by HPLC (relevant to substantially free from nicotinamide dinucleotide) (p.19, 2nd column [0217]; Table 3).
Carr does not disclose a supplement comprising β-nicotinamide mononucleotide.
However, as evidenced by BulkSupplement.com, a supplement can simply be the bioactive compound without any other additives. Thus, Carr teaches a supplement comprising β-nicotinamide mononucleotide.
Carr does not disclose the reactivity of the compound with lactate dehydrogenase being 30 units or higher.
However, as evidenced by McPherson, nicotinamide mononucleotide can bind to lactate dehydrogenase-AMP complex (p.45, 3rd paragraph).
Thus, the crystalline beta nicotinamide mononucleotide taught by Carr necessarily has reactivity with lactate dehydrogenase as evidenced by McPherson. The reactivity of 30 units or higher is being interpreted as a desired result, and does not materially change the required structure of the beta nicotinamide mononucleotide.
Regarding claim 2, the limitation identifying the reactivity of the compound with lactate dehydrogenase as being “33 units or higher” is being interpreted as a desired result based on a property of the compound that does not materially distinguish the chemical structure of the required compound comprising β-nicotinamide mononucleotide.
Carr teaches amorphous beta nicotinamide mononucleotide was weighed into a glass vial with deionized water to form a clear solution, which was stirred and then mixed with methanol to produce a white solid which was isolated and dried to provide crystalline beta nicotinamide mononucleotide form 1 (p.18, 1st column, [0208] Example 1). Carr teaches that crystalline form 1 remained unchanged in terms of solid form and particle morphology at all conditions tested, remaining chemically pure (~99.3%) after 4 weeks of storage at all the tested conditions as tested by HPLC (p.19, 2nd column [0217]; Table 3).
Carr is silent on the reactivity of the compound with lactate dehydrogenase being 33 units or higher.
However, as evidenced by McPherson, nicotinamide mononucleotide can bind to lactate dehydrogenase-AMP complex (p.45, 3rd paragraph).
Thus, the crystalline beta nicotinamide mononucleotide taught by Carr necessarily has reactivity with lactate dehydrogenase as evidenced by McPherson. The reactivity of 33 units or higher is being interpreted as a desired result, and does not materially change the required structure of the beta nicotinamide mononucleotide.
Regarding claim 3, Carr teaches amorphous beta nicotinamide mononucleotide was weighed into a glass vial with deionized water to form a clear solution, which was stirred and then mixed with methanol to produce a white solid which was isolated and dried to provide crystalline beta nicotinamide mononucleotide form 1 (p.18, 1st column, [0208] Example 1).
Regarding claim 4, the limitation “wherein the lactate dehydrogenase is lactate dehydrogenase derived from mammalian skeletal muscle” is directed towards properties of lactate dehydrogenase, which is not required by the claimed compound comprising β-nicotinamide mononucleotide. Thus, Carr’s teaching to provide crystalline beta nicotinamide mononucleotide form 1 anticipates the compound required by claim 4 (p.18, 1st column, [0208] Example 1).
Regarding claim 5, the limitation “wherein the lactate dehydrogenase includes an amino acid sequence of SEQ ID NO:1” is directed towards properties of lactate dehydrogenase, which is not required by the claimed compound comprising β-nicotinamide mononucleotide. Thus, Carr’s teaching to provide crystalline beta nicotinamide mononucleotide form 1 anticipates the compound required by claim 5 (p.18, 1st column, [0208] Example 1).
Response to Arguments
Applicant argues that claim 1 recites that the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof is substantially free from nicotinamide dinucleotide, which also satisfies (i) a purity of 95% or higher of β-NMN when measured by HPLC and (ii) a reactivity thereof with lactate dehydrogenase of 30 units or higher (See Remarks dated 3/23/2026, p.8 2nd paragraph). Applicant argues that Carr does not disclose these features, and as supported by Applicant-submitted references 1-3, NAD exists in a living body and β-NMN is easily metabolized to NAD in vivo (See Remarks dated 3/23/2026, p.8 3rd paragraph). Applicant argues that Carr does not disclose a condition or a method in which β-NMN is substantially free from NAD, as claim 1 recites, and there is no reason to assume that Carr’s β-NMN preparation is substantially the same composition as that of claim 1 including β-NMN that is substantially free from NAD; i.e. NAD is not detected by measurement with HPLC.
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive. Although Carr discusses that NAD is produced from β-NMN, Carr also discloses β-NMN measured by HPLC and determines a purity of greater than 99%, suggesting that the β-NMN is substantially free of NAD. Further, Applicant’s references 1-3 discuss the metabolism of β-NMN into NAD in a living body, and under in vivo conditions. The instant claims are directed towards a composition comprising β-NMN, which Carr teaches as a crystalline β-NMN having 99.3% purity that remained after several weeks, which means the β-NMN is substantially free of NAD. Measuring purity and reactivity of the β-NMN are characterizing properties of the β-NMN, but does not structurally differentiate the composition of β-NMN from the teachings of Carr.
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.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (US 2018/0282361 A1, published October 4, 2018; previously cited) in view of BulkSupplements, (“NMN Nicotinamide Mononucleotide” from BulkSupplements.com (https://www.bulksupplements.com/products/nicotinamide-mononucleotide-nmn); previously cited).
Regarding claim 7, Carr teaches amorphous beta nicotinamide mononucleotide was weighed into a glass vial with deionized water to form a clear solution, which was stirred and then mixed with methanol to produce a white solid which was isolated and dried to provide crystalline beta nicotinamide mononucleotide form 1 (p.18, 1st column, [0208] Example 1).
Carr teaches that purity analysis was performed on an Agilent HP1100 series system equipped with a diode array detector and using ChemStation software vB.04.03 using the method detailed in Table 1 (description p.18, [0206]; Table 1). Carr teaches that crystalline form 1 remained chemically pure (~99.3%) after 4 weeks of storage at all the tested conditions (i.e. substantially free from nicotinamide dinucleotide) (description p.19, [0217]).
Carr further teaches isolating the crystals, e.g., by filtering the crystals, by decanting fluid from the crystals, or by any other suitable separation technique, and in further embodiments, the preparation method further comprises washing the crystals (i.e. recovering the β-nicotinamide mononucleotide) (description p.2, [0034]).
Carr does not disclose producing a pharmaceutical composition or supplement comprising β-nicotinamide mononucleotide.
However, BulkSupplement.com teaches a supplement comprising nicotinamide mononucleotide bioactive compound without any other additives.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recover the β-nicotinamide mononucleotide in crystalline form taught by Carr to produce a powder nicotinamide mononucleotide supplement, because BulkSupplement teaches a pure powder form of nicotinamide mononucleotide that is ready for consumption. One of ordinary skill in the art would have found it beneficial to have pure dried crystalline form of β-nicotinamide mononucleotide that could be used to produce any formulation one chose.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (US 2018/0282361 A1, published October 4, 2018; previously cited) in view of McPherson (“Interaction of Lactate Dehydrogenase with is Coenzyme, Nicotinamide-Adenine Dinucleotide”, Journal of Molecular Biology, 1970, Vol. 51, Issue 1, pp.39-46; previously cited).
Regarding claim 8, Carr teaches amorphous beta nicotinamide mononucleotide was weighed into a glass vial with deionized water to form a clear solution, which was stirred and then mixed with methanol to produce a white solid which was isolated and dried to provide crystalline beta nicotinamide mononucleotide form 1 (p.18, 1st column, [0208] Example 1). Carr teaches that purity analysis was performed on an Agilent HP1100 series system equipped with a diode array detector and using ChemStation software vB.04.03 using the method detailed below in Table 1 (description p.18, [0206]; Table 1). Carr teaches that crystalline form 1 remained unchanged in terms of solid form and particle morphology at all conditions tested, remaining chemically pure (~99.3%) after 4 weeks of storage at all the tested conditions as tested by HPLC (p.19, 2nd column [0217]; Table 3).
Carr does not disclose measuring a reactivity with lactate dehydrogenase.
McPherson teaches nicotinamide mononucleotide can bind to lactate dehydrogenase-AMP complex (p.45, 3rd paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further measure a reactivity of β-nicotinamide mononucleotide as taught by McPherson, because one would reasonably expect that measuring a reactivity of β-nicotinamide mononucleotide would predictably result in being able to determine whether the reactivity is 30 units or higher.
Response to Arguments
Applicant argues that claim 7 recites features similar to those of Claim 1, namely selecting the β-NMN in crystalline form having a purity of 95% or higher as measured by HPLC and having reactivity with lactate dehydrogenase of 30 units or higher, and further that the β-nicotinamide mononucleotide or a pharmacologically acceptable salt thereof having the bioavailability is substantially free from nicotinamide dinucleotide (NAD) (See Remarks dated 3/23/2026, p.9 2nd paragraph). Applicant argues that as discussed above, Carr does not disclose selecting the β-NMN in crystalline form having a purity of 95% or higher as measured by HPLC and having reactivity with lactate dehydrogenase of 30 units or higher nor that the obtained β-NMN is substantially free from NAD, and accordingly claim 7 is distinguished from Carr for at least the reasons disclosed above for claim 1 (See Remarks dated 3/23/2026, p.9 3rd paragraph). Applicant argues that BulkSupplement discloses NMN is a building block for NAD, and the reference is silent regarding any means to reduce the amount of NAD for the β-NMN to be substantially free from NAD, and further, without any guidance in the cited references, there is no reason that a person having ordinary skill in the art is motivated to satisfy all (i) a purity of 95% or higher when measured by HPLC; (ii) a reactivity thereof with lactate dehydrogenase of 30 units or higher, much less expect that β-NMN satisfying (i) and (ii) above is substantially free of NAD as claim 7 recites (See Remarks dated 3/23/2026, p.9, last 2 paragraphs).
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive. Claim 7 recites a process of preparing a solution of β-NMN; measuring purities of the β-NMN using HPLC; measuring reactivities with lactate dehydrogenase of β-NMN; and recovering the β-NMN. Each of these steps are taught in the art by Carr. The steps of measuring purity by HPLC and reactivity with lactate dehydrogenase are characterizing the properties of β-NMN, and do not distinguish the structure of the composition of β-NMN from that taught by Carr. Carr teaches preparing a solution of β-NMN; measuring purity of the β-NMN using HPLC; and recovering β-NMN crystals. McPherson teaches that β-NMN reacts with lactate dehydrogenase; therefore one of ordinary skill in the art would reasonably expect that adding a step of characterizing the reactivity of β-NMN with lactate dehydrogenase would predictably result in obtaining a β-NMN with the desired reactivity of 30 units or higher.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/DEEPA MISHRA/Examiner, Art Unit 1657
Prosecution Insights