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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 8-16) in the reply filed on 11/12/2025 is acknowledged. Applicant’s election of “anemia, leukopenia and/or thrombocytopenia” is also acknowledged.
Claims 4-7 and 19 have been canceled, claims 1-3 and 17-18 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 8-16 have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The earliest priority date of the instant application is the filing date of the foreign priority document which is 9/28/2020.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 3 and 10 are objected to because of the following informalities: the terms listed in claims 3 and 8, e.g. Nicotinic Acid, Nicotinamide, Nicotinamide Riboside, etc. are starting with a capital letter. They should be in a lower case. Appropriate correction is required.
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 8-16 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 Objections
Claims 9 and 11 are objected to because of the following informalities:
Claim 9 discloses the term “methylcobalamine”. This term is in typographical error of “methylcobalamin”.
Claim 11 discloses the “composition” of claim 8. As claim 8 has been amended to “method”, claim 8 should be directed to “method” instead of “composition”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description Rejection
Claims 8-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The treatment:
The instant claims disclose “a method for use in treatment of anemia, leukopenia or thrombocytopenia comprising a combination of a NAD+ precursor and vitamin B12 to a subject in need of same.”
The term “treatment” is not particularly defined in the instant specification. However, the specification discloses that “treatment include curative, palliative and prophylactic treatment” (para. 169 of PGPub).
Thus, the scope of “treatment” would encompass prevention, relieving/ameliorating, and cure of the claimed conditions, i.e. anemia, leukopenia and/or thrombocytopenia.
The instant specification generally discloses the prophetic embodiments indicating that the claimed method or composition may be useful in treating various diseases without showing any working embodiments. The conditions being treated, i.e. anemia, leukopenia or thrombocytopenia, can be treated and thus the symptoms of these conditions can be alleviated by various known means in the art.
However, it is not known in the art that if the entire scope of the claimed conditions would be cured or even alleviated by the claimed method. The claimed method merely states that the combination of a NAD+ precursor and vitamin B12 would sufficiently and necessarily prevent, alleviate and/or cure the conditions as claimed. However, the scope of the conditions is extremely broad to encompass those caused by mere nutritional deficiency or caused by chemotherapy, radiation, and/or drugs; infections; cancers; and genetic abnormalities (e.g. immunodeficiency). The claims disclose any of these conditions regardless of the causes would be prevented, alleviated or cured by the claimed method. There is no sufficient written description in the instant application to support the claimed scope.
The specification discloses in vitro experimentation showing that the combination of nicotinamide riboside and vitamin B12 would induce lowering of mitochondrial membrane potential in mouse HSCs. This is insufficient to support that even if the combination of NR and vitamin B12 would effectively induce the same in vivo, there is no indication that the induced HSCs in vivo would necessarily and sufficiently “treat” including “prevent”, “alleviation” and/or “cure” the claimed conditions, particularly the scope of the claimed conditions are extremely broad, and yet there is no detailed written description to support the entire scope of the diseases with regard to “prevention”, “alleviation” and “cure” encompassed by the claimed scope.
The prevention:
The instant claims disclose “a method for use in prevention of anemia, leukopenia or thrombocytopenia comprising a combination of a NAD+ precursor and vitamin B12 to a subject in need of same.”
As discussed above, the scope of the “treatment” would also include “prevention” and the following discussion would be applicable to the “treatment” above.
The scope of anemia is broad without any limit and thus it encompasses not only those caused by deficiencies in iron, vitamin B12 or folate but also includes an inherited genetic disorders (aplastic anemia) such as sickle-cell anemia, thalassemia, Fanconi anemia, etc. While the anemia caused by the deficiencies in iron, vitamin B12 or folate can be prevented by supplementing these in diet, it is not known in the art at the time of filing whether or not these conditions as claimed would be preventable.
The instant specification does not provide sufficient written description to support the entire scope of anemia being prevented. It is acknowledged that the instant specification discloses that subjects having or at risk of developing subnormal amounts of hematopoietic cells include those suffering from blood cancers, blood disorders including genetic abnormalities, those undergoing chemotherapy, etc. (para. 193 of PGPub). However, there is no disclosure to support that the claimed composition comprising NAD+ precursors and Vitamin B12 would necessarily prevent the genus of anemia encompassed by the claimed invention. The specification merely states that the method would prevent anemia, and as discussed above, it is known in the art that iron, vitamin B12 and/or folate deficiency caused anemia can be prevented.
It is submitted that the instant specification fails to provide sufficient written description to support that the claimed method would necessarily and sufficiently prevent any of claimed conditions caused by any conditions.
The specification discloses in vitro experimentation showing that the combination of nicotinamide riboside and vitamin B12 would induce lowering of mitochondrial membrane potential in mouse HSCs. This is insufficient to support that even if the combination of NR and vitamin B12 would effectively induce the same in vivo, there is no indication that the induced HSCs in vivo would necessarily and sufficiently “prevent” the claimed conditions.
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
M.P.E.P. § 2163 also recites, “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention… one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.” and further, “The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084.< Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims >present in the application when originally filed,< even if the specification discloses only a method of making the invention and the function of the invention. See, e.g., In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) ("One skilled in the art would know how to program a microprocessor to perform the necessary steps described in the specification. Thus, an inventor is not required to describe every detail of his invention. An applicant's disclosure obligation varies according to the art to which the invention pertains. Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out."). In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.”
Scope of Enablement Rejection
Claims 8-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for anemia caused by deficiency in NAD+ and/or vitamin B12 in a subject, does not reasonably provide enablement for anemia/leukopenia/thrombocytopenia caused by genetic abnormalities and/or HSC deficiency. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988) (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The instant claims disclose “a method for use in treatment or prevention of anemia, leukopenia or thrombocytopenia comprising a combination of a NAD+ precursor and vitamin B12 to a subject in need of same.”
The term “treatment” is not particularly defined in the instant specification. However, the specification discloses that “treatment include curative, palliative and prophylactic treatment” (para. 169 of PGPub).
Thus, the scope of “treatment” would encompass prevention, relieving or ameliorating, and cure of the claimed conditions, i.e. anemia, leukopenia and/or thrombocytopenia. The term “prevention” is a part of the “treatment” in their scope.
The instant specification generally discloses the prophetic embodiments indicating that the claimed method or composition may be useful in treating various diseases without showing any working embodiments. The conditions being treated, i.e. anemia, leukopenia or thrombocytopenia, can be treated and thus the symptoms of these conditions can be alleviated by various known means in the art.
there is no disclosure to support that the claimed composition comprising NAD+ precursors and Vitamin B12 would necessarily prevent the genus of anemia encompassed by the claimed invention.
The specification merely states that the method would prevent, alleviate or cure any anemia, and as discussed above. The scope of “anemia” is broad. It is known in the art that iron, vitamin B12 and/or folate deficiency caused anemia can be prevented. However, it is also known in the art that sickle-cell anemia cannot be prevented therapeutically except two people who carry the sickle cell gene to avoid having a child together (see Sickle cell anemia, 2025). Aplastic anemia such as Fanconi anemia is caused by HSC deficiency in inherited bone marrow failure syndromes (see Adam et al. 2016, Stem cells; p.285, 1st col.).
The instant specification does not provide working embodiment/example to support the claimed prevention or cure of anemia by genetic problem (e.g. sickle cell anemia, thalassemia or Fanconi anemia, etc.).
Similarly, leukopenia or neutropenia is a condition referring to lowered numbers of white blood cells (neutrophil) can be caused by chemotherapy, radiation, leukemia, aplastic anemia, infections, autoimmune disease, or nutritional deficiencies. It is also known in the art that there are genetic abnormalities cause leukopenia/neutropenia. For example, congenital neutropenia such as Kostman and myelokathexis syndrome are known in the art that they are caused by genetic mutations. As discussed above, the inherited bone marrow failure syndromes would lead to leukopenia/neutropenia due to deficiency of HSCs. The instant specification does not provide any working embodiment/example to support the prevention or cure of leukopenia by any known causes let alone those caused by genetic abnormalities. This is also applicable to the “thrombocytopenia” as claimed.
The specification discloses in vitro experimentation showing that the combination of nicotinamide riboside and vitamin B12 would induce lowering of mitochondrial membrane potential in mouse HSCs. It appears that the effect of the combined NR and vitamin B12 causing to HSCs would require intact HSCs in a subject. As discussed, the claimed condition caused by immunodeficiency, e.g. lacking HSCs caused by genetic defects as in aplastic anemia, This is insufficient to support that even if the combination of NR and vitamin B12 would effectively induce the same in vivo, and thus, the induced HSCs would prevent, alleviate and/or cure any of conditions as claimed.
Thus, it is highly unpredictable if the claimed method would sufficiently and necessarily produce the claimed effect of preventing, alleviating or curing the entire scope of the claimed conditions. Particularly, as discussed above, the finding by the inventors appears that HSCs would be induced by the claimed composition to lower mitochondrial membrane potential, and it appears that the lowering mitochondrial membrane potential would increase the function of HSCs. However, the increased functionality of HSCs do not necessarily translate into prevention, alleviation or cure of the claimed conditions considering there are various causes for the claimed conditions.
The instant specification fails to provide sufficient guidance to achieve the claimed outcome using the composition as claimed. M.P.E.P. § 2164.03 reads, “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The ‘amount of guidance or direction’ refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“In applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required.”).”
The level of one of ordinary skill in the art at the time of invention was advanced, being that of a person holding a Ph.D. or an M.D.; however, because of lacking any guidance or working embodiment/example, and its unpredictability as discussed above, one of skill in the art at the time of filing would consider that applicant would not have been able to make and/or use the invention claimed, to its fully-claimed scope, without undue experimentation.
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 8-16 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.
Claims 8-16 are directed to a method for use in the treatment or prevention of the listed types of diseases/conditions. However, there is no active step disclosed in the claims. Rather the method is disclosed to comprise a combination of products. Therefore, it is not clear if the claims are directed to a method or a product. Clarification is required.
Claim 8 discloses the term “same” at the end. It is not clear what this term intends to point out. Is it referring to “treatment” or “prevention” or something else.
Claim 11 discloses “The composition according to claim 8”. There is no antecedent basis for the “composition” as claim 8 has been amended. Further it is not clear if this claim is directed to a product claim or it is a method claim and the claim is referring to the product used in the method of claim 8. Clarification is required. For search purpose, claim 11 is interpreted as a method claim limiting the method of claim 8.
Claim 12 discloses “the urolithin” in line 2. There is no antecedent basis for the term as claim 8 does not disclose “urolithin”. For search purpose, claim 12 is interpreted as: “The method according to claim 8, wherein the combination of a NAD+ precursor and Vitamin B12 is in the form of a pharmaceutical or nutritional composition or meal replacement beverage.”
Claim 14 discloses that the subject has anemia, leukopenia and thrombocytopenia. As claim 8 is directed to a method for use in the treatment or prevention of the conditions as claimed, the subject having the conditions cannot be prevented as claimed. It is not clear how the claimed use in the prevent would be carried out in the subject already having the conditions. Clarification is required.
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 8-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they are directed to “use” (i.e. “Use” claims) which does not fall into any one of the statutory classes. See MPEP§2173.05(q).
Claim Interpretation
Claim 8 is interpreted as a method of administering a combination of a NAD+ precursor and vitamin B12 to a subject having anemia.
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) 8, 10, 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ellis et al. (AU2006200036; published 7/26/2007).
Ellis et al. teach a pharmaceutical composition comprising vitamin B3 (nicotinamide) and vitamin B12 (p.7, lines 11-18).
The limitation directed to a subject in need of same (claim 8) and a subject at risk of having subnormal amounts of hematopoietic cells (claim 13) is broadly interpreted as a normal subject. Ellis et al. teach that vitamin B12 is needed to prevent anemia (p.13, lines 28-30), and the subject being any subject in need of preventing fatigue, stress, lack of energy (p. 7, lines 7-9). Thus, the subject taught by Ellis et al. would be considered as those of claimed scope.
Thus, the reference anticipates the claimed invention.
Claim(s) 8, 10, 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chernyshova et al. (US 2019/0282613 A1; published on 9/19/2019)
Chernyshova et al. teach a method of preventing and/or treating anemia by using an injectable composition comprising vitamin B12 and nicotinamide, i.e. NAD+ precursor (see Abstract; para. 24; Table 2).
Thus, the reference anticipates the claimed invention.
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(s) 8-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vannini et al. (US2017/0252362 A1; IDS ref.) in view of Chernyshova et al. (supra) and Verma et al. (2017, Pediatr. Blood Cancer).
Regarding claims 8 and 14, Vannini et al. teach a method of preventing and/or treating a decreased blood cell level in a subject comprising administering an effective amount of a mitochondrial membrane potential reducing agent in a subject by injecting or as a food supplement (para. 86). Vannini et al. teach that the condition having a decreased blood cell level is secondary to a primary or autoimmune disorder of the hematopoietic system, for example including, but not limited, to congenital bone marrow failure syndromes, idiopathic thrombocytopenia, aplastic anemia and myelodysplastic syndromes (para. 122).
Regarding vitamin B12, Vannini et al. do not teach the limitation.
Chernyshova et al. teach a method of preventing and/or treating anemia by using an injectable composition comprising vitamin B12 and nicotinamide, i.e. NAD+ precursor (see Abstract; para. 24; Table 2). Chernyshova et al. teach that the composition promotes hematopoiesis (Abstract).
It would have been obvious to a person skilled in the art to use the components utilized in the composition of Chernyshova et al. including vitamin B12 for the purpose of preventing and/or treating a decreased blood cell level taught by Vannini et al. for the same purpose with a reasonable expectation of success.
Regarding claim 9, Vannini et al. in view of Chernyshova et al. do not teach vitamin B12 is methylcobalamin.
However, it is well known in the art that methylcobalamin is used for vitamin B12 deficiency and forms according to Verma et al. (see entire document).
It would have been obvious to a person skilled in the art to use methylcobalamin as vitamin B12 taught by Chernyshova et al. in the method of Vannini et al. with a reasonable expectation of success.
Regarding claim 12, Vannini et al. teach that the mitochondrial membrane potential reducing agent is pharmaceutical formulations (para. 115) and the agent is nicotinamide riboside (para. 89).
Regarding claim 13, Vannini et al. teach that the subject is suffering from disease or disorders associated with a decreased blood cell level resulting from a reduction or an absence of haemopoietic function or patients at risk of developing a decreased blood cell level as compared to a control blood cell level (para. 120).
Regarding claim 15, Vannini et al. teach that the subject is a hematopoietic stem cell post-transplanted subject (para. 124).
Regarding claim 16, Vannini et al. teach that the mitochondrial membrane potential reducing agent, combined with at least one co-agent useful in HSC ablative chemotherapy regimens, such as G-CSF analogues (para. 119).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 8-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8-16 of copending Application No. 18/246744 (reference application) in view of Verma et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘744 application are directed to a method and composition identical to the instant claims except the claims of the ‘744 application further disclose urolithin. The claims of the ‘744 application do not disclose methylcobalamin as vitamin B12. However, it is well known in the art that methylcobalamin is vitamin B12 utilized for treating anemia according to Verma et al. Thus, it would have been obvious to a person skilled in the art to use methylcobalamin for the method of ‘744 application.
Thus, the claims of the ‘744 application in view of Verma et al. render the claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631