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 with traverse of Group I, claims 1-12, drawn to a compound of formula (I) or formula (I’), and a pharmaceutical composition comprising the compound; and compound 5 having the structure of:
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as the elected species of the compound in the reply filed on October 30, 2025 is acknowledged. The traversal is on the ground(s) that there is no serious burden imposed in examining Groups II and III with the elected Group I. This is not found persuasive because the inventions require a different filed of search. For instance, inventions I and II are independent or distinct because the product as claimed can be used in a materially different process of using that product, such as cell-based assay; Inventions I and III are also independent or distinct because the product as claimed can be used in a materially different process of using that product, such as stability and shelf-life test; and Invention II and III are independent and distinct because they are not capable of use together as the method of analysis or in vitro screening requires different active steps and does not require the performance of treating, alleviating, or preventing the claimed disease, disorder or abnormality in the subject. As such, there would be an examination burden as these distinct inventions would require different field of search.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4-7 and 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 30, 2025.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected compound species of formula (I) or formula (I’) conducted by the Examiner discover a prior art by Zhang et al. that anticipates the claimed invention, wherein the prior art teaches a compound I-106; However, it is noted that the prior art does not teach the elected compound species. In light of this discovery, the search is expanded to the subject matter of the compound to include compound I-106 of Zhang et al. in addition to the elected compound specie such that it does not encompass the full scope of the claims.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on October 30, 2025, wherein claims 1-12 and 14-21 are unchanged; and claim 13 is cancelled.
Claims 1-12 and 14-21 are pending. Claims 4-7 and 14-21 are withdrawn.
Claims 1-3 and 8-12 are under examination in accordance with the elected species along with the expanded species set forth in the Expansion of Election of Species Requirement section above.
Priority
The instant application 18/222,115 filed on July 14, 2023 claims priority to, and the benefits of Foreign Application No. EP22185021.7 filed on July 14, 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/19/2023 and 10/25/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Please note the foreign references without an English translation but have an English
translation of the abstract will only have the abstract considered by the Examiner.
Specification
The abstract of the disclosure is objected to because the abstract recites the term “novel” in line 1. It is suggested that the term “novel” be deleted from the language of the abstract. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel or new, since the scope of the invention no longer embraces what is considered “novel”. Thus, the incorporation of the term
“novel” into the language of the specification is not appropriate.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Pyrrolotriazine and Imidazotriazine Derivatives as Modulators of the NLPR3 Inflammasome Pathway.
Please note the term “novel” is not considered as part of the title of an invention, said term should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. See MPEP § 606 with respect to Title of Invention.
The disclosure is objected to because of the following informalities: the specification is repleted with the term “novel” (see e.g., page 1, line 5, 10 and 17). It is suggested that the term “novel” be deleted from the language of the disclosure. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel or new, since the scope of the invention no longer embraces what is considered “novel”. Thus, the incorporation of the term “novel” into the language of the specification is not appropriate.
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.
Claims 1-3 and 8-12 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.
Claim 1 recites “[a] compound of formula (I)… or a stereoisomer, a racemic mixture, a tautomer, a polymorph, a pharmaceutically acceptable salt, a prodrug, a hydrate, or a solvate thereof”; and Claim 2 recites “[a] compound of formula (I’) … or a stereoisomer, a racemic mixture, a tautomer, a polymorph, a pharmaceutically acceptable salt, a prodrug, a hydrate, or a solvate thereof”. There is insufficient written basis for the polymorph, the prodrug, the hydrate and the solvate of the compound of formula (I) and formula (I’) in the specification.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.I "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5,2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure ..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In this case, Applicant has failed to provide any structural characteristics, chemical formula, name(s) or physical properties of the polymorph, the prodrug, the hydrate and the solvate of the compound of formula (I) and formula (I’) in the specification, aside from a broad recitation that such are contemplated for use in the invention. As such, it is not apparent that Applicant was actually in possession of, and intended to be used within the context of the present invention, any specific polymorph, prodrug, hydrate and solvate of the compound of formula (I) and formula (I’) in the specification at the time the present invention was made.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the specification is the description of the term “prodrug” recites in the following: “the term ‘prodrug’ means any covalently bonded compound which release the active parent pharmaceutical due to in vivo biotransformation” (see page 67, line 35 to page 68, line 3 of the instant specification). In other words, the specification does not provide sufficient description to describe the structure and functional characteristics of the prodrug, aside from the recitation that it can be any covalently bonded compound that release the active parent drug. The specification does not provide sufficient description for the polymorph, the prodrug, the hydrate and the solvate of the compound of formula (I) and formula (I’). Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Therefore, the scope of the claims containing any species of polymorph, prodrug, hydrate and solvate of the compound of formula (I) and formula (I’) fails to comply with the written description
requirement, because the polymorph, prodrug, hydrate and solvate are not described in the specification in such a way as to reasonably encompassed any species of polymorph, prodrug, hydrate and solvate due to the limited disclosure provided.
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 1-2 and 8-11 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.
Regarding claims 1-2, 9 and 10, the term "preferably” renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. Description of examples or preference is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). In order to advance prosecution, the examiner is examining the claims to the extent that the limitations following the term “preferably” are omitted.
Regarding claims 8-11, the claims recite the limitation of "[t]he compound of formula I, I’, Ia, Ib, Ic, Id or Ie according to claim 1" in the preamble. There is insufficient antecedent basis for the compound of formula I’, Ia, Ib, Ic, Id and Ie in the claim. In order to advance prosecution, the examiner is examining the claim to the extent that it is drawn to the compound of formula I sets forth in claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8-10 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US 2024/0262806 A1).
Zhang et al. teaches a compound I-106, 2-(4-([(3R)-1-methylpiperidin-3-yl]amino}pyrrolo[1,2-d][1,2,4]triazin-1-yl)-5-(trifluoromethyl)phenol, having the structure of:
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is an exemplary compound of generic Formulae I that demonstrates IL-1[Symbol font/0x62] inhibitory effect that could be used to treat disease mediated through NLRP3 activation (see e.g., p. 222, Table I, Compound Number I-106; [0373]; claim 14). Zhang et al. further teaches a pharmaceutical composition comprising a therapeutically effective amount of the compound or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable carriers (see e.g., claim 16; [0042]).
In this case, the compound I-106 taught by Zhang et al. is a compound of instant Formula (I):
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, wherein
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is
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; Y is NH; R3 is
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, R4 is -CH3; R0 is -H; R1 is -CF3; and R2 is -OH.
Therefore, the claimed invention is being anticipated by Zhang et al. et al.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2024/0262806 A1).
Zhang et al. teaches a compound I-106, 2-(4-([(3R)-1-methylpiperidin-3-yl]amino}pyrrolo[1,2-d][1,2,4]triazin-1-yl)-5-(trifluoromethyl)phenol, having the structure of:
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is an exemplary compound of generic Formulae I that demonstrates IL-1[Symbol font/0x62] inhibitory effect that could be used to treat disease mediated through NLRP3 activation (see e.g., p. 222, Table I, Compound Number I-106; [0373]; claim 14). Zhang et al. further teaches the compound of generic Formulae I can have the structure of Formula IX:
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(see e.g., claims 1, 2, 9); and provides that the core of Formulae IX-XI may additionally be, but are not limited to, any of the following structure which may be optionally substituted with one or more R4: inter alia,
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,
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(see e.g., [1110]). Zhang et al. further teaches a pharmaceutical composition comprising a therapeutically effective amount of the compound or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable carriers (see e.g., claim 16; [0042]). Zhang et al. further the compounds of Formulae I-XI or a form thereof may contain asymmetric or chiral centers, and, therefore, may exist in different stereoisomeric forms (see e.g., [1274]). Zhang et al. further teaches the compounds of Formulae I-XI or a form thereof described herein may include one or more chiral centers, and as such may exist as racemic mixtures (R S) or as substantially pure enantiomers and diastereomers (see e.g., [1274]-[1275]).
In the present case, the difference between the compound I-106 of Zhang et al. and the elected compound 5 of the claimed invention is that the prior art contains pyrrolo[1,2-d][1,2,4]triazine rather than imidazo[1,2-d][1,2,4]triazine (see shaded):
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. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select Compound I-106 of Zhang et al., and then modify said compound by replacing
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with
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in the core. One would have been motivated to do so, because Zhang et al. teaches the core of Formulae IX-XI, which are subgenus formulae of generic Formulae I, can be
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or
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to arrive at a compound with IL-1[Symbol font/0x62] inhibitory effect useful for treating disease mediated through NLRP3 activation. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by replacing the pyrrolo[1,2-d][1,2,4]triazine (
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) with imidazo[1,2-d][1,2,4]triazine (
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) at the core of the compound I-106 would have successfully demonstrate IL-1[Symbol font/0x62] inhibiting effect; and therefore, said modified compound I-106 of Zhang et al. can successfully combine with one or more pharmaceutically acceptable carriers to arrive at a pharmaceutical composition without any appreciable loss of activity.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHIHYI LEE/Examiner, Art Unit 1628
/JEAN P CORNET/Primary Examiner, Art Unit 1628