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 .
Detailed Action
This application is a national stage application of PCT/JP2023/002617, filed January 27, 2023, which claims priority to foreign application JP2022-011518, filed January 28, 2022. Claims 1-12 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted July 26, 2024, is acknowledged wherein claims 6 and 11 are amended.
Information Disclosure Statement
The information disclosure statement filed April 16, 2026, fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The information disclosure statement submitted August 9, 2024, is purely redundant with the information disclosure statement submitted July 26, 2024. Every reference appearing in the later IDS also appears in the previous IDS. Therefore it is not separately considered.
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)(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, 2, 4-7, and 9-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lasmezas et al. (PCT international publication WO2022/104105, Reference included with PTO-892)
Claim 1 is directed toward a method of stabilizing NAD in a sample comprising contacting the sample with nicotinamide or a nicotinamide derivative. Dependent claim 2 further defines the nicotinamide derivative as including nicotinamide.
Lasmezas et al. discloses assays for NAD detection and quantification, for example as diagnostic methods for disease. (p. 1 lines 12-14, p. 3 lines 14-25) This method includes protesting NAD in a biological sample using an inhibitor of NAD degradation, optionally disrupting, clarifying, and fractionating the biological sample, and detecting or quantifying NAD in the biological sample. (p. 3 lines 26-31) In a specific embodiment the inhibitor of NAD degradation nis nicotinamide, thereby anticipating claims 1 and 2, as well as claim 6 when the measuring step is performed. (p. 4 lines 1-3) Since this process includes optional pretreatment steps before measuring NAD, performing any of these steps would infringe claim 7. Furthermore practicing such a method would necessarily involve obtaining a composition comprising nicotinamide, thereby infringing claims 9-11.
Regarding claim 4, p. 4 lines 25-27 of Lasmezas disclose that the biological fluid being tested can be blood or cerebrospinal fluid. Regarding claim 5, p. 9 lines 15-16 of Lasmezas describes human subjects as being preferred.
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lasmezas et al. (PCT international publication WO2022/104105, Reference included with PTO-892)
The disclosure of Lasmezas et al. is discussed above. Lasmezas further discloses kits comprising reagents for carrying out the disclosed methods. (p. 36 line 26 – p. 37 line 21) While Lasmezas et al. does not specifically disclose a kit comprising a stabilizing reagent such as nicotinamide and further comprising a reagent for measuring NAD in a sample, it would have been obvious to one of ordinary skill in the art at the time of the invention to produce a kit comprising these two reagents. The description of kits containing reagents for “treating or monitoring the condition,” described in the disclosure of Lasmezas would suggest including both a stabilizing reagent and a measuring reagent together since both of these reagents are involved in the methods of monitoring the condition.
Therefore the invention taken as a whole is prima facie obvious.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lasmezas et al. as applied to claims 1, 2, 4-7, and 9-12 above, and further in view of Balan et al. (Reference included with PTO-892)
The disclosure of Lasmezas et al. is discussed above. Lasmezas et al. does not specifically disclose a process in which the measuring step comprises treating the pretreated sample with a dehydrogenase, NAD+, diaphorase, and a tetrazolium salt.
Balan et al. discloses a method for quantitation of NAD(H) levels. (p. 113 left column third paragraph) The process involves incubating a biological sample with a dehydrogenase, diaphorase, and nitrotetrazolium blue chloride, a tetrazolium salt. (p. 113 figure 1) This method can both detect and quantify levels of NAD+ in the sample . (p. 114 right column last paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the assay described by Balan et al. as the measuring step in the process described by Lasmezas et al. One of ordinary skill in the art would have seen that Lasmezas et al. does not describe the particualrs of the measuring step and would have looked to the art for a measuring protocol that could quantitate NAD in a biological sample.
Therefore the invention taken as a whole is prima facie obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lasmezas et al. as applied to claims 1, 2, 4-7, and 9-12 above, and further in view of Ningbo Helin Health Technology Co.,Ltd. (Foreign patent publication CN111269957, Reference included with PTO-1449, herein referred to as Ningbo)
The disclosure of Lasmezas et al. is discussed above. Lasmezas et al. does not specifically disclose a process wherein the concentration of nicotinamide is between 10-500 mM. However, Ningbo discloses a similar method wherein the concentration of nicotinamide used is 100-150 mM. (p. 2 paragraphs 8-13) It would have been obvious to one of ordinary skill in the art at the time of the invention to use the higher concentration described by Ningbo in the method of Lasmezas et al., as Ningbo describes this concentration as appropriate for a similar method.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 9/10/2026
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