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 .
Status of the Claims
Claims 14-16 and 21-37 are pending. Claims 27-28 and 34 are withdrawn. Claims 14-16, 21-26, and 29-32 are rejected. Claims 33 and 35-37 are objected to.
Information Disclosure Statement
The Information Disclosure Statement (IDS) from 8/30/2023 was considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group II and the species C77:
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in the reply filed on 2/20/2026 is acknowledged.
Claims 14-16, 21-26, 29-33, and 35-37 embrace Applicant’s elected species and are therefore under examination. Applicant’s elected species is allowable. As per MPEP 803.02, “Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.” In the interest of compact prosecution, non-elected species have been rejected below under 35 USC 103. Additionally, claims 33 and 35-37 were examined in full and are free of the art.
Claims 27-28 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 15 is objected to because of the following informalities: Claim 15 does not end in a period. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: Claim 32 does not end in a period. Appropriate correction is required.
Claim 36 is objected to because of the following informalities:
Species C105 and C78-4 are identical; remove one;
C107 and C78-13 are identical; remove one.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 16 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “autoimmune disease”, and the claim also recites “Multiple Sclerosis” and “rheumatoid arthritis”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Examiner recommends clearly listing the precise disorders and diseases for which patent protection is sought.
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.
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.
Claim(s) 14, 16, 21-23, 29, 30, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US20070066583).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Zhang teaches compounds that have utility in treating inflammatory disorders, such as rheumatoid arthritis and multiple sclerosis (see para. [0004] and [0006]). Zhang specifically discloses the following compound in Example 11 (see para. [0176]):
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of a compound of instant Formula I treating a neuroinflammatory disorder, such as multiple sclerosis or rheumatoid arthritis.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 14, 16, and 21-23, the prior art Example 11 is embraced by a compound of instant formula I:
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, wherein, R5 = halogen (Cl); n = 1; R3 and R4= H; R1 and R2, together with the nitrogen to which they are attached form a non-aromatic heterocyclyl substituted with aryl. It would have been obvious to a skilled artisan to treat a subject with a neuroinflammatory disorder, such as multiple sclerosis or rheumatoid arthritis, with a compound of instant formula I, as taught by the prior art, with a reasonable expectation of success. A PHOSITA would have been motivated to treat such a subject with the prior art compound shown supra in an effort to successfully treat a neuroinflammatory disorder.
Regarding instant claim 29, which depends from instant claim 14, in no instance for the scenario wherein R1 and R2 together with the nitrogen to which they are attached form a non-aromatic heterocyclyl…from claim 14, as the prior art compound shown supra encompasses, is the presence of “p” required. Therefore, the prior art is not required to teach this limitation.
Regarding instant claim 30, which depends from instant claim 14, in no instance for the scenario wherein R1 and R2 together with the nitrogen to which they are attached form a non-aromatic heterocyclyl…from claim 14, as the prior art compound shown supra encompasses, is the presence of Ra or Rb required. Therefore, the prior art is not required to teach this limitation.
Regarding instant claim 31, which depends from instant claim 14, in no instance for the scenario wherein R1 and R2 together with the nitrogen to which they are attached form a non-aromatic heterocyclyl…from claim 14, as the prior art compound shown supra encompasses, is the presence of R10 required. Therefore, the prior art is not required to teach this limitation.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US20070066583) as applied to claims 14, 16, 21-23, 29, 30 and 31 above, and further in view of Guo et al. (Clinical and Experimental Immunology, 2018, 194: 231-243).
The 103 rejection supra over Zhang et al. of claims 14, 16, 21-23, 29, 30 and 31 is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Zhang fails to disclose the role of NLRP3 in the disorder of rheumatoid arthritis.
Guo teaches that “NLRP3 inflammasome activation contributes to the pathogenesis of rheumatoid arthritis” (see title).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment in the prior art of specifically treating a neuroinflammatory disorder that involves the dysregulation of one or more NLR’s with a compound of instant formula I.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 15, it would have been obvious to a skilled artisan to treat a neuroinflammatory disorder, such as rheumatoid arthritis, with a compound of instant formula I. NLRP3 inflammasome activation was known to contribute to the pathogenesis of rheumatoid arthritis, prior to the effective date of the claimed invention. A skilled artisan would have been motivated to treat rheumatoid arthritis with a compound of instant formula I in an effort to reduce or eliminate a patient’s symptoms, with a reasonable expectation of success.
Claim(s) 14, 16, 21-26, 30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadari et al. (US20190022074).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Hadari teaches compositions for treating inflammatory diseases, such as rheumatoid arthritis (see abstract and para. [0368]). In one embodiment, the composition mentioned above may include the following compound (see p. 71, left column, second compound):
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of a compound of instant formula I treating rheumatoid arthritis in the prior art.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 14, 16, 21-26, and 32, the prior art compound shown supra is embraced by a compound of instant formula I:
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, wherein R5 = H; n = 1; R3 and R4 = H; R2 = H; R1 = -(CRaRb)p-Q-R10; p = 0; Q =
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; R10= heterocyclyl,
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. It would have been obvious to a skilled artisan to treat a subject with a neuroinflammatory disorder, such as rheumatoid arthritis, with a compound of instant formula I, as taught by the prior art, with a reasonable expectation of success. A PHOSITA would have been motivated to treat such a subject with the prior art compound shown supra in an effort to successfully treat a neuroinflammatory disorder.
Regarding instant claim 30, which depends from instant claim 14, because p is zero in the prior art species above, as permitted by both claims 14 and 30, Ra and Rb were not required to be taught by the prior art. (See the following definition from claim 14:
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). In no location in claim 14 is the presence of Ra or Rb required. Therefore, the prior art is not required to teach this limitation.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadari et al. (US20190022074), as applied to claims 14, 16, 21-26, 30 and 32 above, and further in view of Guo et al. (Clinical and Experimental Immunology, 2018, 194: 231-243).
The 103 rejection supra over Hadari et al. of claims 14, 16, 21-26, 30 and 32 is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Hadari fails to disclose the role of NLRP3 in the disorder of rheumatoid arthritis.
Guo teaches that “NLRP3 inflammasome activation contributes to the pathogenesis of rheumatoid arthritis” (see title).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment in the prior art of specifically treating a neuroinflammatory disorder that involves the dysregulation of one or more NLR’s with a compound of instant formula I.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 15, it would have been obvious to a skilled artisan to treat a neuroinflammatory disorder, such as rheumatoid arthritis, with a compound of instant formula I. NLRP3 inflammasome activation was known to contribute to the pathogenesis of rheumatoid arthritis, prior to the effective date of the claimed invention. A skilled artisan would have been motivated to treat rheumatoid arthritis with a compound of instant formula I in an effort to reduce or eliminate a patient’s symptoms, with a reasonable expectation of success.
Allowable Subject Matter
Claims 33, 35, 36 and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art are the two non-elected species rejected under 35 USC 103 supra; neither provide motivation to render the instant claims 33 and 35-37 obvious nor anticipated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy 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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/MEGHAN C HEASLEY/Examiner, Art Unit 1626