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 .
Information Disclosure Statement
The information disclosure statement filed 11/17/2025 and 4/27/26 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been fully considered, since several references were not provided in either the instant or parent applications. Applicant is required to provide copies of the missing references to be considered by the examiner.
Claim Rejections - 35 USC § 112(a), Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 and 3-6 are rejected under 35 U.S.C. §112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicants are directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112 ¶1 "Written Description" Requirement, Rev. 1, 2008; at http://www.uspto.gov/web/menu/written.pdf.
The claims broadly embrace a medicine for oral disease comprising a nicotinamide mononucleotide as an active agent and a method for improving oral disease comprising applying an effective dose of nicotinamide mononucleotide to a target in need thereof, necessitating structure/function relationships.
The specification discloses a few diseases (periodontal disease, halitosis, or xerostomia) within the scope of claims 1 and 6 (any oral disease) having the required activities. However, the specification is silent with regards to any and all oral diseases that would also include for example, oral cancer, cavities, gingivitis, oral herpes, stomatitis and others. Therefore, the artisan, would not have accepted that applicant was in possession of the claimed medicine for oral diseases and method of use.
Thus, it is clear that Applicants' description of structure and activity regarding the genus of oral diseases is based in large part on conjecture.
As the specification fails to describe the structure and activity for the genus of oral diseases, the disclosed species of periodontal disease, halitosis, or xerostomia does not constitute a substantial portion of the claimed genus.
Applicant’s attention is also directed to In re Shokal, 113 USPQ 283 (CCPA 1957), wherein it is stated:
It appears to be well settled that a single species can rarely, if ever, afford sufficient support for a generic claim. In re Soll, 25 CCPA (Patents) 1309, 97 F2d 623, 38 USPQ 189; In re Wahlforss, 28 CCPA (Patents) 867, 117 F2d 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of small genus such as the halogens, consisting of four species, a reduction to practice of three, perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably larger number of reductions to practice would probably be necessary.
As stated in MPEP 2163 II: If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. The instant specification is devoid of a description for the numerous possible oral diseases that could be treated by the claimed compound. The specification merely discloses the structure and function of nicotinamide mononucleotide treating periodontal disease, halitosis, or xerostomia, previously described in the prior art. Thus, Applicants have failed to demonstrate possession of treating any and all oral diseases by the use of nicotinamide mononucleotide as claimed. Disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing “a result that one might achieve if one made that invention”); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail such that the Artisan can reasonably conclude that the inventor(s) had possession of the claimed invention. Such possession may be demonstrated by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and/or formulae that fully set forth the claimed invention. Possession may be shown by an actual reduction to practice, showing that the invention was “ready for patenting”, or by describing distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention (January 5, 2001 Fed. Reg., Vol. 66, No. 4, pp. 1099-11).
Therefore, the breadth of the claims as reading on numerous oral diseases that can be treated by nicotinamide mononucleotide, including those yet to be discovered; in view of the level of knowledge or skill in the art at the time of the invention, and the limited information provided in the specification, an Artisan of skill would not recognize from the disclosure that Applicant was in possession of the numerous amphipathic weak bases claimed, at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied.
Claim Rejections - 35 USC § 112(b)
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.
Claim 6 is 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 6 is unclear in that it recite “A method for improving oral disease (excluding medical practice to human)…”. The species recited in the parentheses (i.e., excluding medical practice to human) renders the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102(a)(1)
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by You et al. (Frontiers in Pharmacology, Dec 2020, vol 11, Article 604404, 1-10).
You is directed to nicotinamide mononucleotide used orally [Title]. You teaches that nicotinamide mononucleotide, a key precursory metabolite of NAD+, has been shown to elevate the cellular levels of NAD+ and ameliorate various age-related diseases [Abstract]. The study highlights the safety of NMN, providing a possible safe dose range for oral administration of NMN [Abstract].
With regards to instant claim 1, You teaches animal experimentation using nicotinamide mononucleotide (NMN) dissolved in sterile water [see Materials and Methods; Animal Experimentation – p. 2].
With regards to the intended use recited in instant claims 1-2 and 4, the Examiner notes that a recitation of the intended use of the claimed invention (for oral disease; for periodontal disease, halitosis or xerostomia; and for improving oral disease, respectively) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With regards to instant claim 3, it is noted that food product is not specially defined in the specification and therefore the broadest reasonable interpretation would include a liquid formulation (e.g., a beverage). The above teaching of You (NMN dissolved in sterile water) reads on such.
Therefore, by teaching all the limitations of claims 1-4, You anticipates the instant invention as claimed.
Claim Rejections - 35 USC § 102(a)(2)
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)(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 1-4 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al. (US 2024/0173239; published: 5/30/24; filed on 1/28/22).
Wang is directed to oral care additive, oral care composition and uses thereof [Title].
With regards to instant claim 1, Wang teaches an oral care additive comprising at least one main ingredient, nicotinamide or a derivative thereof and an auxiliary ingredient (vitamin and coenzyme), wherein the nicotinamide or derivative thereof is β-nicotinamide mononucleotide [see claims 1 and 6; and para. 0009]. Wang teaches that the use of said oral care additive is for the treatment, prevention or relief of an oral disease [see claim 22].
With regards to instant claims 1-2 and 6, Wang teaches the abovementioned oral care additive and a use thereof; specifically, Wang teaches the use of the additive by adding to an existing oral care product to enhance the efficacy of the product (e.g., to treat, prevent or relieve an oral disease such as a periodontal disease or inflammation of the gums) [0008, 0048].
With regards to instant claims 3-4, Wang teaches wherein the oral care additive is in a solid (e.g., powder, paste, gel or crystal), liquid (e.g., solution, slurry) or gaseous form [see claims 7-8]. More specifically, Wang teaches an oral care composition comprising said oral care additive in the form of a chewing gum or tooth cleaning powder (i.e., food product or medicinal product) [see claims 13-14].
Therefore, by teaching all the limitations of claims 1-4 and 6, Wang anticipates the instant invention as claimed.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over You et al. (Frontiers in Pharmacology, Dec 2020, vol 11, Article 604404, 1-10).
As noted in the anticipation rejection above You anticipates claims 1-4 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over You for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
You is directed to nicotinamide mononucleotide used orally [Title]. You teaches that nicotinamide mononucleotide, a key precursory metabolite of NAD+, has been shown to elevate the cellular levels of NAD+ and ameliorate various age-related diseases [Abstract]. The study highlights the safety of NMN, providing a possible safe dose range for oral administration of NMN [Abstract].
With regards to instant claim 1, You teaches animal experimentation using nicotinamide mononucleotide (NMN) dissolved in sterile water [see Materials and Methods; Animal Experimentation – p. 2].
With regards to the intended use recited in instant claims 1-2 and 4, the Examiner notes that a recitation of the intended use of the claimed invention (for oral disease; for periodontal disease, halitosis or xerostomia; and for improving oral disease, respectively) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With regards to instant claim 3, it is noted that food product is not specially defined in the specification and therefore the broadest reasonable interpretation would include a liquid formulation (e.g., a beverage). The above teaching of You (NMN dissolved in sterile water) reads on such.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although You teaches a study that highlights the safety of [oral] NMN, such provides a possible safe dose range for oral administration of NMN [Abstract], You does not specifically teach wherein the daily amount per adult of the nicotinamide mononucleotide to be applied is 1 mg to 500 mg, as required by instant claim 5.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The daily dose (mg) of nicotinamide mononucleotide is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal daily dose (mg) of NMN in order to best achieve the desired results as such would provide advantageous biological effect (e.g., elevation of the cellular level of NAD+ and amelioration of various age-related diseases – see Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, You teaches that NMN elevate the cellular level of NAD+ and ameliorate various age-related diseases [Abstract]. The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the daily dose of NMN would impact the biological effect and therefore be an optimizable variable.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617
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