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 .
Detailed Action
Claims 1, 4, 10-11, 13, 15-16, 18-19, 21-22, 24-28, 30-31, 34-35, 37-40, and 49-52 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1, 4, 10-11, 13, 15-16, 18-19, 21-22, 24-28, 30-31, 34-35, 37-38 and 51-52, drawn to compounds of Formula I) and the elected species, Compound 80
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, in the reply filed on 3/09/2026 is acknowledged.
Claims 15, 19, 24-26, 30-31, 34, 39-40, and 49-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II-III or unelected species, there being no allowable generic or linking claim. Thus, Claims 1, 4, 10-11, 13, 16, 18, 21-22, 27-28, 35, 37-38 and 52 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
The elected species was found to be free of the art. The scope of search and examination was expanded to compounds of Formula I wherein R1 is not joined with an adjacent R1 to form a fused ring with the core bicycle.
Title
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.
Claim Rejections - 35 USC § 112(b)
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 27 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 regards as the invention.
Variables p and ring A, at least, are not defined in either Claim 27 in which they appear or in Claim 1, upon which 27 depends. All such variables must be explicitly defined. For the purpose of compact prosecution, the undefined variables of Claim 27 are interpreted to have the respective definitions described in Claim 18.
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.
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.
Claims 1, 4, 11, 16, 21-22, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seitz (Bioorganic & Medicinal Chemistry Letters 18 (2008) 527–531).
Several compounds of Seitz in Table 1 of Page 529 are anticipatory with respect to the examined Formula I. For example, Compound 7b:
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applies to the following definitions of examined Formula I: X and Y are O; A1, A2, A3, and A4 are CH; R2 is C1alkyl substituted with Z1, wherein Z1 is C(O)OR11, wherein R11 is H; R3, R4, R6, R7, R9 and R10 are H; and R5 is C1alkyl substituted with Z1, wherein Z1 is aryl substituted with Z1a, wherein Z1a is N(R13)2, wherein one R13 is hydrogen and the other is heteroaryl.
Regarding Claim 35, the limitation applies to R1 groups; however, the A variables are not restricted to CR1 rather than CH. Therefore, the above compound does still anticipate Claim 35 despite no R1 group being present.
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.
Claims 1, 4, 10-11, 13, 16, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Seitz (Bioorganic & Medicinal Chemistry Letters 18 (2008) 527–531).
Several integrin antagonist compounds of Seitz in Table 1 of Page 529 are anticipatory with respect to the examined Formula I. For example, Compound 7b:
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applies to the following definitions of examined Formula I: X and Y are O; A1, A2, A3, and A4 are CH; R2 is C1alkyl substituted with Z1, wherein Z1 is C(O)OR11, wherein R11 is H; R3, R4, R6, R7, R9 and R10 are H; and R5 is C1alkyl substituted with Z1, wherein Z1 is aryl substituted with Z1a, wherein Z1a is N(R13)2, wherein one R13 is hydrogen and the other is heteroaryl.
Regarding Claim 35, the limitation applies to R1 groups; however, the A variables are not restricted to CR1 rather than CH. Therefore, the above compound does still anticipate Claim 35 despite no R1 group being present.
With respect to Claim 10, no R1 group is present on Compound 7b; however, R1 may be as simple as C1alkyl. While Seitz does not teach the addition of a methyl group, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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 MPEP 2144.09. Therefore, one of skill in the art seeking to form homologs of the Seitz compounds for the same purpose before the effective filing date of the examined invention would find it obvious, in view of the known and predictable variation described in MPEP, to form a methyl homolog which renders obvious Claim 10.
With respect to Claim 13, R5 is not taught to be a ring. However, removal of the intervening methylene bonded to the aryl and amide of Compound 7b would yield an examined R5 group as follows:
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, wherein R5 is aryl substituted with Z1, wherein Z1 is N(R11)2, wherein one R11 is hydrogen and the other is heteroaryl. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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 MPEP 2144.09. Therefore, one of skill in the art seeking to form homologs of the Seitz compounds for the same purpose before the effective filing date of the examined invention would find it obvious, in view of the known and predictable variation described in MPEP, to form a methylene homolog which renders obvious Claim 13.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Seitz as applied to Claims 1, 4, 10-11, 13, 16, and 21-22 in further view of Ansel (Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th. Wolters Kluwer Health. 2013. Page 102).
The teachings of Seitz are set forth above and incorporated by reference herein.
Ansel teaches “[d]rug substances are seldom administered alone; rather they are given as part of a formulation in combination with one or more nonmedicinal agents that serve varied and specialized pharmaceutical functions.” Liquid carriers can be used to “solubilize, suspend, thicken, dilute, emulsify, stabilize” compounds in solution for delivery.
One of skill in the art seeking to administer the therapeutic taught in Seitz would, in view of Ansel’s teaching that drugs are administered as a formulation, find it obvious to formulate the therapeutic compounds with a carrier in a composition for optimal drug delivery before the effective filing date of the instant application.
Claims 1, 4, 10-11, 16, 21-22, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Koga (US20100113391, published 2010).
Koga teaches Compound 3 as a P2Y12 inhibitor (Abstract; Page 68, Table 49):
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,
in which the following definitions of examined Formula I apply: A1 and A4 are CH; A2 and A3 are CR1 wherein each R1 is halo and N(R11)2, wherein each R11 is H and C6cycloalkyl; R2 is C5 cycloalkyl, R3, R6, R7, R9, and R10 are hydrogen; X and Y are O; R5 is C2 alkyl. Koga teaches compounds of the invention can be formulated as pharmaceutical compositions with carriers (Page 93, Claim 12).
Koga fails to teach the same compound wherein the ester linkage is an amide. Koga teaches amide as an acceptable alternative embodiment, however, at the same position in Formula I:
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, wherein one of the Koga R11s is H. The modification is obvious and expected to form an acceptable PYR12 inhibitor because Koga teaches the lead compound as well as guidance for modifying said compound before the effective filing date.
Claims 1, 4, 10-11, 13, 16, 18, 21-22, 27, 35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Conn (WO2008151184).
Conn teaches mGluR5 modulators (Abstract), including the following compound on Page 193:
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, in which the following definitions of examined formula II apply: R1 is C2alkynyl substituted with Z1, wherein Z1 is aryl, and p is 1; R2, R3, R6, R7 and R4 are H; Ring A is C3cycloalkyl.
Alternatively, the definitions of examined formula VII apply as follows: R1 is C2alkynyl substituted with Z1, wherein Z1 is aryl, and p is 1; R2 and R3 are H; Ring A is C3cycloalkyl.
Both formulae are encompassed by examined Formula I.
Conn does not teach alternative R2 groups. However, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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 MPEP 2144.09. Therefore, one of skill in the art seeking to form homologs of the Conn compounds for the same purpose before the effective filing date of the examined invention would find it obvious, in view of the known and predictable variation described in MPEP, to form a methyl homolog yielding a mGluR5 modulator.
The compounds of Conn are also taught to be included in pharmaceutical compositions comprising carriers (Para 18, 21, and 61).
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.
PROVISIONAL:
Claims 1, 4, 10-11, 13, 16, 18, 21-22, 27-28, 35, 37-38 and 52 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-19 of copending Application No. 18852324 (hereinafter referred to as Tenvie).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a NLRP3 inhibitors which are homologs and compositions thereof. Instant Claims 1, 4, 10-11, 13, 16, 18, 21-22, 27-28, 35, 38 are anticipated by the cited compounds of Tenvie.
Tenvie teaches methods of use which require the instant compounds.
Regarding Claim 37, Tenvie teaches Compound 42:
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which differs from examined Compound 42:
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in that a methyl is absent. However, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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 MPEP 2144.09. Therefore, one of skill in the art seeking to form homologs of the Tenvie compound for the same purpose before the effective filing date of the examined invention would find it obvious, in view of the known and predictable variation described in MPEP, to form a methyl homolog and expect it to form an NLRP3 inhibitor.
Regarding Claim 52, Tenvie teaches Compound 27:
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which differs from the following examined compound:
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(Page 63) in that a second fluoride is attached to the cyclopropyl. However, Claim 8 of Tenvie teaches that Z1 (the fluoride position) may be once or twice substituted on the same core. Therefore, one of skill in the art seeking to form an NLRP3 inhibitor homolog would find it obvious to modify Compound 27 by removing a Z1 group, fluoride.
Since both applications teach NLRP3 inhibitor homologs of the same core, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Tenvie.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights