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 .
Restriction/Election
Applicant’s election without traverse of Group I (Claims 15-16,18-19, and 21), in the reply filed on August 4, 2026 is acknowledged. Claims 1-14,17,20,22-73 are canceled. Election was made without traverse in the reply filed on August 4, 2026.
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.
Claims 15-16,18-19, and 21 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 a method for treating a fibrotic disorder, the method comprising administering by the following methods: injection (intravenous, intramuscular, intraarterial) or inhalation (nebulizer, inhaler) to a subject in need therefore an antagonist of nicotinamide adenine dinucleotide kinase 2 (NADK2) in an amount effective to treat the fibrotic disease, does not reasonably provide enablement for a method for treating a fibrotic disorder, the methods comprising: administering to a subject in need thereof an antagonist of nicotinamide adenine dinucleotide kinase 2 (NADK2) in an amount effective to treat the fibrotic disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc. 8 USPQD2d 1217 (Fed. Cir. 1988). Whether undue experimentation is required is a conclusion reached by weighing several factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in In re Wands, 8 USPQQ2d 1400 (Fed. Cir. 1988).
While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirements, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experiment to make and use the invention based on the content of the disclosure is undue.
Nature of the Invention:
The claims recite a method of administering an antagonist of NADK2 in an effective amount to treat a fibrotic disorder.
Breadth of Claims:
The claims are so broad that they encompass any method of administration to any part of the subject to treat any fibrotic disorder.
Teachings from the Prior Art:
Paragraphs 23 and 225 of Brunskill (US 20170189525) state that the agent (NADK2 antagonist) can be administered subcutaneously, intraperitoneally, intra-muscularly, intra-arterially, intravenously, intramuscularly, nasally, subcutaneously, or parenterally. This means that an agent is administered into the body in order to treat a fibrotic disorder. There is no evidence that a fibrotic disorder can be treated by placing a topical composition containing a NADK2 antagonist anywhere on the body to treat any fibrotic disorder. There is no evidence in the prior art that the agent can be successfully administered and prepared for ingestion so that it serves as an effective treatment for any fibrotic disorder. There is no evidence presented that the agent can be successfully delivered to a subject in need to treat a fibrotic disorder by administering the composition to the ear or eye.
Applicants Specification/Guidance/Working Examples:
The specification states that the composition containing a NADK2 antagonist can be administered to a subject by the following methods: injection (intravenous, intramuscular, intraarterial), inhalation (nebulizer, inhaler), ingestion (oral, rectal, vaginal), sublingual or buccal dissolution, ocular placement, otic placement, or absorbed through skin (cutaneous, transdermal) to treat any fibrotic disorder. There is no teaching that administration by ingestion and or topical administration of a NADK2 antagonist can inhibit every type of fibrotic disorder when administered. It is unclear what carrier for ingestion needs to be used to successfully deliver the NADK2 antagonist to the target area so that it does not get destroyed in the gastrointestinal tract. Furthermore, it is unclear how topical, ocular, or otic administration of the NADK2 antagonist is able to allow for the successful treatment of a condition such as pulmonary fibrosis when applied to an area such as the feet, ear, or eye.
Conclusion:
The instant claims encompass treating any type of fibrotic condition with any type of administration to any portion of the body. The specification does not provide adequate support that shows that any method of administration will result in successfully treating any type of fibrotic disorder. The claims need to be narrowed so that the methods of administration used treat a broad range of fibrotic conditions. The prior art cited above teaches that methods of administration involving injecting or inhalation can treat many different type of fibrotic disorders.
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.
Claim 16 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 16 recites that “the fibrotic disorder is characterized by increased levels of NADK2 and/or pyrroline-5-carboxylate synthase (P5CS) relative to a known reference. This limitation is indefinite because it is not clear what the known reference is. Claim 18 corrects the indefiniteness because it states that the reference value is from a normal cell of the subject.
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)(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 15-16,18-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brunskill (US 20170189525) in light of Sou “Folinate Supplementation Ameliorates Methotrexate Induced Mitochondrial Formate Depletion in Vitro and In Vivo” Int. J. Mol. Sci, 2021, 22, 1350.
Brunskill discloses a method of treating a fibrotic disorder, the method comprising administering (Abstract, Paragraph 22-23 of Brunskill) to a subject in need thereof an antagonist of nicotinamide adenine dinucleotide kinase 2 (NADK2)/methotrexate (Paragraph 409 of Brunskill) in an amount effective to treat the fibrotic disorder (Abstract). Sou is applied to teach that methotrexate is a NADK2 antagonist (Sou, Page 2, paragraph 4) as in instant 15. Applicants specification states that fibrotic disorders such as pulmonary fibrosis and liver fibrosis can cause the following: increased levels of: an extracellular matrix protein, collagen, elastin, fibronectin, and laminin compared to a normal cell of the subject (Paragraphs 17-19 of the specification). Paragraph 22 of Brunskill teaches that methotrexate can be used to treat pulmonary fibrosis and liver fibrosis which inherently have the characteristics recited in claims 16,18-19, and 21 as in instant Claims 16,18-19, and 21.
The reference anticipates the claimed limitation.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
