DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on June 25, 2026, has been received and entered.
Claim Disposition
3. Claims 1-19 and 30-35 were canceled. Claims 20-29 and 36 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on June 25, 2026, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Claim objection
5. Claims 20-29 and 36 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 20 is amended to recite “A method for treating [[an]] inflammatory bowel disease in a human subject, [[said method]] comprising:
administering to …..….. [[said]] wherein the composition [[being]] is administered by a parenteral route’’. The dependent claims hereto is also included.
For clarity it is suggested that claims 21-29 and 36 are amended to recite, “of”, instead of “according to”.
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.
6. Claims 20-29 and 36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention as amended is directed to “a method for treating an inflammatory bowel disease in a subject… comprising administering to the subject a composition comprising a kynurenine aminotransferase… said composition being administered by a parenteral route. The claimed invention is not adequately described because it encompasses a large variable genus of subjects which could be a huma or a cat for example. In addition, the invention as claimed is not adequately described with respect to the treatment regimen. It is noted that the dependent claims provide the types of inflammatory bowel disease and KAT, however, the independent claim is very broad and need to stand on its own. Further, there are claims drawn to at least 80% sequence identity to for example KAT proteins in SEQ ID NOs: 1-32 and encompasses orthologs thereof without the actual reference sequence provided. In addition, the recitation of at least 80% sequence identity to for example, SEQ ID NO:1 to 32 encompasses also a vast amount of structures that are not adequately described as this includes a lot of variability and structures that are not specifically claimed (selected from human KATII, orthologs thereof, variants thereof, said variants having at least 80% sequence identity to human KATII or any ortholog thereof…)”. Note that no correlation is made between structure and function. The claimed invention also encompasses any NAD precursor thereof, which is overly broad. The claimed invention is not adequately described and is not commensurate in scope with the disclosure in the specification. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
7. 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.
8. Claim(s) 20-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/136792 (of record in the application) in view of Moderna ( US Patent No. 9, 107,886, 8/18/15).
The primary reference teaches the use of kynurenic acid (KYNA), for example, a metabolite of kynurenine aminotransferases (KATs) in the treatment of colitis and other inflammatory bowel diseases (see paragraphs 070, 04-05 and 026-027). The reference in paragraphs, 072-073 340 and 418, teach that a potential therapeutic approach may include the administration of engineered bacteria to the gut, wherein the bacteria express genes for enzymes involved in the biosynthesis of kynurenic acid, for example, KAT I, KAT II, KAT III, KAT IV. Additionally, these enzymes, additionally to KYNA, are also known to synthesize xanthurenic acid (XANA). The reference teaches to administer See the entire document. The primary reference does not teach administration via parenteral route; however, Moderna et al. teach treatment of colitis with a parenteral route with diseases such as ulcerative colitis among others (see paragraph 01032 of the patent and entire document).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching renders the claimed invention as obvious. Motivation to combine exist because they are analogous art. Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
9. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicants’ comments are moot. Note that the rejections of record remain for the reasons above and herein.
The applicant states that the use of according to is maintained because it refers back to the previous claim. The suggestion of using ‘of’ is more appropriate in this setting of the claim language, i.e. The method of claim 1, wherein X is…..”, compared to “The method according to claim 1, wherein X is. According to seems more geared towards stating a universal rule, like ‘according to MPEP 2100’ or ‘according to In re….”. However, applicant can be their own lexicographer, the examiner has rendered a suggestion that is maintained to put the best language forward in the claims. Applicant traverses the rejection under 112, first paragraph stating that the invention is adequately described. It is noted that applicant deleted language like variants and derivatives but kept ‘ortholog’. However, the fact that the claims recite at least 80% sequence identity to the copious amounts of sequences remains directed to fragments, derivative, orthologs and variants. The rejection also remains based on how the claims broadly is directed to any subject. Applicant has not demonstrated possession of the large variable genus encompassed in the claims. Thus, the rejection remains and is final.
Regarding the art rejection, claim 1 was inadvertently listed as the lead claim but it was intended for claim 20 based on the description of the text and as applicant pointed out claim 1 is cancelled. The rejection has been modified based on amendments made to the claims.
Conclusion
10. No claims are presently allowable.
11. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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