DETAILED ACTION
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 April 5, 2024, has been received and entered.
Claim Disposition
3. Claims 1-19 has been canceled. Claims 20-36 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on April 5, 2024, 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. Note references have been lined through because of improper citation of dates.
Drawing
5. The drawings filed on April 4, 2023, have been accepted by the examiner.
Specification Objection
6. The specification is objected to for the following informalities:
The specification is also objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. See pages 11, for example. It is suggested that http:// is deleted.
The specification is objected to because organism names are not italicized see Table 2 on pages 8-9 and Table 4, and throughout specification.
The specification is objected to because trademarks are disclosed and they are not capitalized. The use of the trademark such as TRITON, has been noted in this application (see page 35, for example). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks".
Appropriate correction is required.
Claim objection
7. Claims 20-36 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 20 is amended to recite “…..[[said method]] comprising [[administering to the subject a composition comprising]] :
administering to the subject a composition having a kynurenine………to express and secrete [[said]] the kynurenine…..product of [[said]] the kynurenine……’’. The dependent claims hereto is also included.
For clarity it is suggested that claims 22-36 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.
8. Claims 20-36 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 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 and/or a living recombinant bacterium which has been genetically modified to express and secrete the kynurenine aminotransferase which is xanthurenic acid, derivative thereof or a pharmaceutically acceptable salt or solvate thereof.
The claimed invention is not adequately described because it encompasses a large variable genus of enzymes with the recitation of derivative, orthologs, variant thereof and at least 80% sequence identity to for example human KAT II 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. Further, the invention encompasses a microorganism that is asserted as live and recombinant that is genetically modified to express and secrete the enzyme, however, not adequately described to recited the microorganisms and the modifications. The claimed invention also encompasses any salt thereof, product 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.
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.
9. Claims 25-27 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 25-27 are indefinite because they recite “at least 80% sequence identity” and do not provide a reference sequence for comparison.
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 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.
10. Claim(s) 1, 25-27, 30-31 and 34-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/136792 (of record in the application).
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. The reference in paragraph 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). See the entire document. Therefore, the limitations of the claims are met by the reference.
Conclusion
11. No claims are presently allowable.
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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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652