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 are maintained.
Claims 4-5 and 14-21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions and species, there being no allowable generic or linking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.
Newly added claim 23 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on April 13, 2026, wherein claims 1, 6-7 and 13 are cancelled; claims 2-5, 8-12, 14, 18 and 21 are amended; claims 15-17, 19-29 are unchanged; claims 22-24 are newly added.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-5, 8-12 and 14-24 are pending.
Claims 4-5 and 14-21 remain withdrawn. Newly added claim 23 is withdrawn.
Claims 2-3, 8-12, 22 and 24 are under examination in accordance with the elected species.
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.
Action Summary
Acknowledgement is made of the receipt and entry of the amendment to the title of the invention, the abstract of the disclosure, and the disclosure filed on April 13, 2026.
The amendment to the title of the invention overcomes objection previously set forth in the Non-Final Office Action mailed on November 13, 2025; However, upon further consideration, said title of the invention has been objected to in light of the amendment.
The amendment to the abstract of the disclosure overcome each and every objection previously sets forth in the Non-Final Office Action mailed on November 13, 2025.
The objection to the disclosure sets forth in the Non-Final Office Action mailed on November 13, 2025 are maintained for the reasons set forth herein.
Claims 1-3 and 8-12 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 are maintained, but revisited and modified in light of the claim amendments for the reasons set forth herein.
Claims 1-2 and 8-11 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 are withdrawn in light of the claim amendments that delete the recitation of “preferably” and formula I, Ia, Ib, Ic, Id and Ie.
Claims 1, 8-10 and 12 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US 2024/0262806 A1) are withdrawn in light of claim amendments.
Claims 1-3 and 8-12 rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2024/0262806 A1) are maintained, but revisited and modified in light of the claim amendments for the reasons set forth herein.
Specification
The title of the invention appears to contain typographical error. The instant title of the invention recites ““MODULATORS OF THE NLPR3 LNFLAMMASOME PATHWAY”; However, the disclosure of the instant application recites “NLRP3 inflammasome pathway”.
The following title is suggested: “MODULATORS OF THE NLRP3 INFLAMMASOME PATHWAY.”
The disclosure remain 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.
Response to Arguments
Applicant's arguments filed on April 13, 2026 with respect to the objection of the disclosure have been fully considered but they are not persuasive.
In Summary, Applicant argues the term “novel” recited in the specification reflects the invention as of the date of filing, not as of the date of being made public or being patented; therefore, the objection to the term “novel” should be withdrawn.
In response, applicant’s argument is not found persuasive. Applicant’s argument that the invention described in the specification is “novel” as of the date of filing appears to be mere argument, because compound I-106 of Zhang et al. (cited in the 102 rejection sets forth in the previous Non-Final Office Action mailed on November 13, 2025) clearly anticipates the compound of formula (I) disclosed in the instant specification and also has a rejection under 35 U.S.C. 103 (see rejection below); thus, applicant’s assertion that the invention described in the disclosure is considered “novel” at the date of filing is not found persuasive. Again, 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 invention described in the disclosure is no longer novel or new. Given these reasons above, the incorporation of the term “novel” into the language of the disclosure is not appropriate, and the objection to the disclosure is maintained for the same reasons of the record and for the reasons set forth herein.
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 2-3 and 8-12 remain rejected and claims 22 and 24 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 (partially newly applied as necessitated by amendment).
Instant amended claim 2 recites “a hydrate, or a C1-4 alcohol solvate thereof”. There is insufficient written basis for the hydrate and the C1-4 alcohol solvate of the compound of 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 hydrate and the C1-4 alcohol solvate of the compound of 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 hydrate and C1-4 alcohol solvate of the compound of 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 specification does not provide sufficient description for the hydrate and the C1-4 alcohol solvate of the compound of 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 hydrate and C1-4 alcohol solvate of the compound of formula (I’) fails to comply with the written description requirement, because the hydrate and C1-4 alcohol solvate are not described in the specification in such a way as to reasonably encompassed any species of hydrate and C1-4 alcohol solvate due to the limited disclosure provided.
Response to Arguments
Applicant's arguments filed on April 13, 2026 with respect to the rejection of claims 1-3 and 8-12 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 have been fully considered but they are not persuasive.
Applicant amends the claim(s) from the recitation of “or a stereoisomer, a racemic mixture, a tautomer, a polymorph, a pharmaceutically acceptable salt, a prodrug, a hydrate, or a solvate thereof” to the recitation of “or a stereoisomer, a racemic mixture, a tautomer, a pharmaceutically acceptable salt, a hydrate, or a C1-4 alcohol solvate thereof”, such that the polymorph and the prodrug form are deleted from the claim language; and the genus solvate is now a subgenus “C1-4 alcohol solvate”. Applicant further amends the dependency of the dependent claims from claim 1 to claim 2. Each of these findings demonstrate the amendment changes the scope of the claims, and necessitates a modification of the rejection on the record.
In Summary, applicant argues one of ordinary skill in the art would have understand the generation and examination of solvates can be conducted using highly automated techniques; and understand that solvates are formed when molecules of a solvent are incorporated into the crystalline structure of the compound in question, by directing attention to page 67, line 8-10 of the specification. Applicant argues conventional knowledge in the art regarding solvates and hydrate reasonably demonstrate applicant is in possession of any solvates/hydrate of the compounds.
In response, Applicant’s argument that page 67, line 8-10 of the specification shown below:
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provide adequate written basis to reasonably convey to one of ordinary skill in the art that applicant is in the possession of any solvates/hydrates of the compounds of formula (I’) is not found persuasive, because the disclosure fails to identify any particular hydrate species or C1-4 alcohol solvate species of compound of formula (I’) spanning across the claimed genus, synthetic preparation, or representative examples thereof, aide from a broad recitation that any solvates and hydrates forms are contemplate for use, and any solvent can be included therein. The mere boiler plate reference to “a hydrate, or a C1-4 alcohol solvate thereof” does not provide adequate blaze marks to the vast genus encompassed by the claims. Thus, the disclosure does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full scope of the claimed “hydrate” and “C1-4 alcohol solvate” at the time of filing.
Given these reasons noted above, the rejection on the record has been maintained, but revisited and modify in light of the claim amendments that changes the scope of the claims; and then newly applied to newly added claims.
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 22 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 (newly applied as necessitated by amendment).
Regarding claim 22, the claim depends on cancelled claim 1. If the base claim has been cancelled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete. See MPEP 608.01(b). In addition, the recitation of “formula I…Ia, Ib, Ic, Id or Ie” in the preamble lacks antecedent basis, it is not clear what formula I, Ia, Ib, Ic, Id or Ie is being referred to by the applicant. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In order to advance prosecution, the Examiner is examining claims 22 to the extent that it is drawn to the compound of formula I’ according to claim 2.
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 2-3 and 8-12 remain rejected and claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2024/0262806 A1) (partially newly applied as necessitated by amendments).
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.
Response to Arguments
Applicant's arguments filed on April 13, 2026 with respect to the rejection of claims 1-3 and 8-12 under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2024/0262806 A1) have been fully considered but they are not persuasive.
Applicant cancelled independent claim 1, and further amends the dependency of the dependent claims 3 and 8-12 from claim 1 to claim 2. Applicant newly added claims 22 and 24. Each of these findings demonstrate the amendment to the claims changes the scope of the claims and necessitates a modification of the rejection on the record.
In Summary, Applicant argues even though Zhang et al. claims priority to, and the benefits of US. Provisional Application No. 63/237,049 filed August 25, 2021, and US. Provisional Application No. 63/311,463 filed on February 18, 2022, the disclosure of Zhang et al. is very broad and does not suggest particular species thereof; none of the disclosure of these US. Provisional applications teaches the replacement of
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with
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; and none of the 118 compounds described in US. Provisional Application No. 63/311,463 exhibits the core structure
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(see e.g., p. 20, 2nd last paragraph in the reply). Applicant further argues the compounds disclosed in the PCT application that exhibits this core structure:
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were added after applicant’s priority date.
In response, applicant’s argument is not found persuasive for the reasons sets forth below:
First, according to MPEP 2123 II, “[d]isclosed examples and preferred embodiments do not
constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d
442, 169 USPQ 423 (CCPA 1971)”. The mere fact that Zhang et al. discloses more than one compound species in the disclosure does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discrete, or otherwise discourage one of ordinary skilled in the art form choosing any one of the exemplified compounds. In fact, these exemplified compounds are clearly a preferred embodiment.
Second, in response to applicant’s argument that Zhang et al. is not entitled to the benefits of the prior-filed applications (US. Provisional Application No. 63/237,049 filed August 25, 2021, and US. Provisional Application No. 63/311,463 filed on February 18, 2022) and has an effectively filing date after applicant’s effective filing date of July 14, 2022, said argument is not found persuasive. Upon careful consideration of these provisional applications, the priority document contains adequate written support for the compound having the structure of:
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as one of the 188 compounds, and having
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or
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as the core of generic Formulae I. Therefore, the cited prior art provides adequate written basis for the modification and is entitled to the earlier priority date for the subject matter.
Therefore, applicant’s arguments are not found persuasive for the reasons set forth herein.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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
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