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 .
CONTINUING DATA
This application is a 371 of PCT/JP2021/043333 11/26/2021
FOREIGN APPLICATIONS
JAPAN 2020-197381 11/27/2020
Claims 1-4 are pending.
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 1-4 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.
Claim 1 recites “having a purity of 99.0% by mass or more.” This limitation is unclear because the claim does not recite how the purity is measured. Paragraph [0083] of the current specification illustrates that the purity % depends on the method of analysis. Claims 2-3 depend from claim 1 and incorporate the same limitation by reference.
Claim 1 recites impurities “equal to or less than a detection limit.” This limitation is unclear because the claim does not recite which detection method is used. The detection limit using one method would be different from the detection limit using another method which has different sensitivity. Claims 2-3 depend from claim 1 and incorporate the same limitation by reference.
Claim 4 recites a method for producing high-purity NMN. The specification does not define “high.” The term “high” in claim 4 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2018023205A1 (machine translation, 2018).
WO2018023205A1 teaches NMN having 99.42% purity. See Table 1.
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611
553
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Greyscale
The impurities recited in claim 1 are not disclosed as being present. Claim 1 recites that the impurities are equal to or less than a detection limit, which includes the absence of impurities. The NMN is used for pharmaceutical purposes or for anti-aging [0002].
Claim Rejections - 35 USC § 103
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 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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over WO2018023205A1 (machine translation, 2018) in view of Rongzhao (US 2018/0230443A1, 2018, cited on IDS) and CN108530505A (machine translation, 2018).
WO2018023205A1 teaches preparation of NMN using the enzyme-catalyzed method [0026]. The NMN is purified using anion exchange [0030].
WO2018023205A1 does not teach the details of the enzyme-catalyzed method and does not teach the use of DAC column.
Rongzhao teaches as an enzyme-based method, a method in which NMN is prepared by the catalytic action of a nicotinamide phosphoribosyltransferase mutant, ribose-phosphatepyrophosphokinase, and AMP nucleosidase, using nicotinamide, ATP, and AMP as source materials (paragraph [0022], example 8). These are the same materials used for the NMN preparation in the current specification.
CN108530505A teaches that a flavonoid glycoside is preferably purified using dynamic axial compression chromatography. Page 2, Step 2.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare NMN using the claimed enzymatic method because WO2018023205A1 teaches that NMN is prepared enzymatically and Rongzhao teaches a procedure for preparing NMN enzymatically. It would have been further obvious to purify the NMN using an added DAC chromatography because WO2018023205A1 desires a pure product, and DAC chromatography is used for purifying glycosides.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693