DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status
Claims 21-35 are pending. Claims 24 and 26-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Therefore, Claims 21-23 and 25 are under examination.
Election/Restrictions
Applicant’s election without traverse of Invention I (Claims 21-23 and 25, drawn to a therapeutic kynurenine production-inhibiting compound and pharmaceutical composition comprising same) and cancer (tumor) in the reply filed on 5/7/2026 is acknowledged.
Claims 24 and 26-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/7/2026.
Priority
This application is a CON of 16/702,939 (12/04/2019) (ABN);
16/702,939 is a CON of 14/827,618 (08/17/2015) (PAT 10548891);
14/827,618 is a DIV of 13/697,143 (11/09/2012) (PAT 9150569);
13/697,143 is a 371 of PCT/JP2011/060654) (05/09/2011).
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 13/697,143, filed on 05/10/2010.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 3/8/2023 has/have been considered by the Examiner. The submission(s) is/are in compliance with the provisions of 37 CFR §§ 1.97 and 1.98. Enclosed with this Office Action is a return-copy of the Forms PTO-1449 with the Examiner’s signature and indication of those references that have been considered.
Claim Rejections - 35 USC § 112 – Scope of Enablement
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.
Claim 25 is 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 inhibiting kynurenine production in vitro, does not reasonably provide enablement for the full scope of a preventative or therapeutic agent for a disease involving the production of kynurenine. 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 the invention commensurate in scope with these claims.
The test of enablement requires a determination of whether the disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention:
The invention relates to a preventative/therapeutic agent for use in a living subject by administering an IDO-pathway inhibitor.
Breadth of claim:
The breadth of the claims is extraordinarily wide: it purports to cover all diseases that involve kynurenine production. The specification teaches the genus of diseases encompassed by the function includes cancer (0105),immune diseases (0106), neurodegenerative diseases (0107), viral infection, bacterial infection, fungal infection, chlamydial infection, rickettsial infection (0108), spanning multiple mechanistically distinct disease classes.
State of the art and predictability:
The art recognized IDO/kynurenine as implicated in many diseases nut the specification’s own background shows translation to therapeutic effect was unpredictable – the antitumor effect “disappears in immunodeficient mice” (0107), i.e., efficacy is dependent upon the host and model.
Therapeutic treatment is highly unpredictable, particularly for asserting in vivo effectiveness across a multitude of disease classes from a single mechanism. The specification confirms this because it distinguishes in vitro result from the in vivo framework (0102). And characterizes the compound activity as speculative (0159). In vitro enzyme/cell inhibition does not establish safe and effective in vivo treatment. See Rasmusson v. SmithKline Beecham Corp. (413 F. 3d 1318, Fed. Cir. 2005).
Relative skill level:
One of ordinary skill in the art is one with access to reagents, tools and equipment used for diagnosing disease, performing tests and/or administering treatment to individuals. The skilled artisan also has many years of training and experience in either the clinical or laboratory environment or both. Therefore, it is clear that the level of skill of one in the art is high. However, this high level of skill is overcome in view of the limited teachings provided by the specification and the unpredictable state of the art, it would require the skilled artisan undue experimentation to make and use the invention commensurate to the scope of the claims.
The amount of direction or guidance provided and the presence or absence of working example:
The specification provides a single example, Test Example 1 (0153-0159), showing an invitro assay measuring kynurenine in IFN-ɣ-stimulated KATO-III cells. The claimed compound is shown only to inhibit kynurenine production in that assay. There are no working examples of preventing or treating any disease in any in vivo model.
The quantity of experimentation necessary:
Because of the known unpredictability of the art, and in the absence of sufficient experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used for treating the multitude of claimed diseases as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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.
A. Claims 21-23 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,548,891 (reference). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims teach a method for inhibiting production of kynurenine by administering an effective amount of a nitrogen-containing heterocyclic compound represented by general formula (I):
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. Exemplary of this formula is the compound claimed in instant Claim 21
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.
Claim 22 is drawn to a pharmaceutical composition comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. The reference’s claimed method of inhibiting production of kynurenine by administration of an effective amount of the compound suggests a pharmaceutical composition containing same.
Claim 23 is drawn to a kynurenine production inhibitor comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. Claim 25 is drawn to a preventive or therapeutic agent for a disease involving the production of kynurenine, comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21.
Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. The claiming of an unknown property which is inherently present in the prior art does not necessarily make the claim patentable. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. The fact that a characteristic is a necessary feature or result of a prior-art embodiment is enough for inherent anticipation. See MPEP § 2112. In this case, the compound taught in the reference claims is the same compound claimed and, therefore necessarily possesses the same properties and functions.
B. Claims 21-23 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 9,150,569 B2 (reference). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a list of nitrogen-containing heterocyclic compounds and pharmaceutically acceptable salts thereof. One of the compounds is N-(3-(2,2,2-trifluoro-1-(6-(2-methyl-2H-1,2,3-triazol-4-yl)pyridin-3-yl)ethoxy)quinoxalin-2-yl)propane-1-sulfonamide which has the following structure:
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. This compound structure represents a racemic mixture that does not specify a stereoisomer such as the one claimed instantly but infers its presence. Additionally, structurally close compounds such as stereoisomers are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.) A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
Claim 22 is drawn to a pharmaceutical composition comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. The reference’s claimed compound has the disclosed utility of an inhibitory effect on production of kynurenine, thereby treating preventing or treating diseases involved the production of kyrynurenin. (Reference specification, column 5, lines 58-62.) This suggests a pharmaceutical composition containing the compound.
Claim 23 is drawn to a kynurenine production inhibitor comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. Claim 25 is drawn to a preventive or therapeutic agent for a disease involving the production of kynurenine, comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. The reference’s claimed compound has the disclosed utility of an inhibitory effect on production of kynurenine, thereby treating preventing or treating diseases involved the production of kyrynurenin. (Reference specification, column 5, lines 58-62.)
C. Claims 21-23 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/107,307 (US 2026/0070891 A1) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims a crystal compound having the structure
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and a method for making compounds of general formula
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. This compound structure represents a close structural stereoisomer of the claimed compound. Structurally close compounds such as stereoisomers are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.) A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious). Here, due to the close structural relationship and same utility, the reference compound renders its instant claimed stereoisomer obvious.
Claim 22 is drawn to a pharmaceutical composition comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. The reference’s claimed compound has the disclosed utility of an inhibitory effect on production of kynurenine, thereby treating preventing or treating diseases involved the production of kyrynurenin. (Reference specification, 0215.) This suggests a pharmaceutical composition containing the compound.
Claim 23 is drawn to a kynurenine production inhibitor comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. Claim 25 is drawn to a preventive or therapeutic agent for a disease involving the production of kynurenine, comprising, as an active ingredient, the nitrogen-containing heterocyclic compound or a pharmaceutically acceptable salt thereof of claim 21. The reference’s claimed compound has the disclosed utility of an inhibitory effect on production of kynurenine, thereby treating preventing or treating diseases involved the production of kyrynurenin. (Reference specification, column 5, lines 58-62.)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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