DETAILED ACTION
Claims 1-21 are pending in the present reissue application.
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 .
Reissue Applications
The present reissue application is a reissue of USPN 11,021,470 (the ‘470 patent).
Non-Compliant Amendment
The “Amendments to the Claims” document filed May 18, 2023 does not comply with 37 CFR 1.173 which sets for the manner of making amendments in reissue applications. While the improper amendment has been entered and considered, a supplemental paper correctly amending the reissue application is required with Applicant’s next response. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
All amendment changes must be made relative to the patent to be reissued, not relative to a previous submitted amendment. Pursuant to 37 CFR 1.173(d), any such changes which are made to the specification, including the claims, must be shown by employing the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets, i.e., single brackets; and
(2) The matter to be added by reissue must be underlined.
The non-compliance issues are as follows:
In claim 2, Q is defined in the original patent as:
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However, Q is defined in the claim amendment of June 1, 2023 as:
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The dash before C(=O)- was not present in the originally patented claims, and needs to be underlined as added subject matter.
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.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-9, 54, 58, 60, 61, and 83 of U.S. Patent No. 10,246,424. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Claim 58 of the ‘424 patent claims the following compound at column 533, lines 15-32:
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, which is covered by claim 1 of the ‘424 patent
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where A is N, G1 and G2 are each N, L1 is a bond, L2 is a bond, X is -O-, n is 2, R1 is aryl, R2a and R2b are halo, R2c is H, m1 and m2 are 2, R3a, R3b, R4a, and R4b are H, and E is an electrophilic moiety capable of forming a covalent bond with the cysteine residue at position 12 of a KRAS, HRAS, or NRAS G12C mutant protein, wherein the electrophilic moiety has the formula
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.
Present reissue claims 1, 7, and 8 are drawn to compounds of the formula
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where A is N, G1 and G2 are each N, L1 is a bond, L2 is a bond, X is -O-, n is 2, R1 is aryl, R2a and R2b are halo, R2c is H, m1 and m2 are 2, at least one of R3a or R3b and one of R4a or R4b are methyl, and E is an electrophilic moiety capable of forming a covalent bond with the cysteine residue at position 12 of a KRAS, HRAS, or NRAS G12C mutant protein, wherein the electrophilic moiety has the formula
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from present reissue claim 17.
The compound from claim 58 of the ‘424 patent differs from the present reissue claims in that all of R3a, R3b, R4a, and R4b are H. However, claims 54 and 83 of the ‘424 patent encompass compounds where one of R3a or R3b and one of R4a or R4b are methyl such as the first compound of claim 83 of the ‘424 patent:
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. The person of ordinary skill would be motivated to substitute the piperazinyl ring from claim 58 of the ‘424 patent in the same way as claim 83 of the ‘424 patent with a reasonable expectation of success as both compounds are claimed as forming a covalent bond with KRAS, HRAS, or NRAS G12C mutant proteins. The resultant compound would be
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, which is the 26th compound of present reissue claim 18. Therefore, claims 1, 7, 8, and 18 are rendered obvious.
With respect to present reissue claims 2 and 15-17, Q is C(=O)-,
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is a double bond, and R9 and R10 are H such that E is
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from present reissue claim 17. Therefore, present reissue claims 2 and 15-17 are rendered obvious.
With respect to present reissue claim 3, the compound in claim 58 of the ‘424 patent corresponds to instant formula (I’b). Therefore, present reissue claim 3 is rendered obvious.
With respect to present reissue claims 4-6, R1 can be phenyl or napthyl substituted by hydroxyl in ‘424 claims 4-9 to yield
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. Therefore, present reissue claims 4-6 are rendered obvious.
With respect to present reissue claims 9 and 11, R6 is
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. Therefore, present reissue claims 9 and 11 are rendered obvious.
With respect to present reissue claim 10, ‘424 claim 58 claims the compound
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where R6 is substituted by oxo such that R6 is
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. Therefore, present reissue claim 10 is rendered obvious.
With respect to present reissue claims 12-14, the compound matches the eighth structure of reissue claim 12
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where R3a and R4a are methyl. Therefore, present reissue claims 12-14 are rendered obvious.
With respect to present reissue claim 19, ‘424 claim 60 covers pharmaceutical compositions comprising a compound of ‘424 claim 1 and a pharmaceutically acceptable carrier. Therefore, present reissue claim 19 is rendered obvious.
With respect to present reissue claims 20 and 21, ‘424 claim 61 covers a method for the treatment of cancer by administering the pharmaceutical composition of ‘424 claim 60. In defining what cancers are covered by ‘424 claim, column 421, lines 54-67 of the ‘424 patent state:
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Therefore, present reissue claims 20 and 21 are rendered obvious.
Claims 1-8, 12-17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 10, 11, and 14-16 of U.S. Patent No. 10,646,488. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Claims 1, 4-6, 10, 11, and 16 of the ‘488 patent claim a conjugate of the formula
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where R1 is aryl or heteroaryl, Y is a direct bond or a linker, X is a heterocyclyl group having the structure
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, B4 is N, CH, or C-CN, and R3a and R4b are C1-C6 alkyl. These compounds anticipate present reissue claims 1, 7, 8 where the compound has the formula
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where A is N, CH, or C-CN; G1 and G2 are each N, L1 is a bond, L2 is a bond, X is -O- or -NR7-, n is an integer from 1 to 6, R1 is aryl, R2a and R2b are halo, R2c is H, m1 and m2 are 2, one of R3a or R3b and one of R4a or R4b are methyl as shown by the species of ‘488 claim 16, and E is an electrophilic moiety capable of forming a covalent bond with the cysteine residue at position 12 of a KRAS, HRAS, or NRAS G12C mutant protein, wherein the electrophilic moiety has the formula
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from present reissue claim 17.
With respect to present reissue claims 2 and 15-17, Q is C(=O)-,
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is a double bond, and R9 and R10 are H such that E is
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from present reissue claim 17. Therefore, present reissue claims 2 and 15-17 are anticipated.
With respect to present reissue claim 3, the ‘488 patent’s claimed compound is of instant formula (I’b). Therefore, present reissue claim 3 is anticipated.
With respect to present reissue claims 4-6, R1 can be phenyl or naphthyl substituted by halo or hydroxyl or both in ‘488 claims 4-6 to yield
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. Therefore, present reissue claims 4-6 are anticipated.
With respect to present reissue claims 12-14, ‘488 claim 16 covers species such as
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that teach the methyl substitution of the piperazinyl ring in line with the ninth structure of present reissue claim 12
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.
With respect to present reissue claim 19, ‘488 claim 14 covers pharmaceutical compositions comprising a compound of ‘488 claim 1 and a pharmaceutically acceptable carrier. Therefore, present reissue claim 19 is anticipated.
With respect to present reissue claims 20 and 21, ‘488 claim 15 covers a method for the treatment of cancer by administering the pharmaceutical composition of ‘488 claim 14. In defining what cancers are covered by the ‘488 claim, column 216, lines 48-56 of the ‘488 patent state:
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Therefore, present reissue claims 20 and 21 are anticipated.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,021,470 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Conclusion
Claims 1-21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Speer can be reached at 313-446-4825. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Alan Diamond/
Patent Reexamination Specialist
Central Reexamination Unit 3991
/T.M.S/Supervisory Patent Examiner, Art Unit 3991