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
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed June 13, 2005, is a reissue divisional of U.S. application Serial No. 18/109,726 filed Feb. 14, 2023, now U.S. Patent RE50,527, which is a reissue of U.S. Patent 10,919,850 (hereinafter the ‘850 patent), which issued from U.S. application Serial No. 16/355,258 (the ‘258 application) with claims 1-38 on Feb. 16, 2021.
Non-Compliant Amendment
The amendment filed 07/29/2026 is improper. The amendment does not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. While the improper amendment has been entered and considered, Applicant’s next response should be a compliant amendment. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
The amendment uses bracketing to show deletion from new claims. This is improper since, as noted in MPEP 1453.V.D, new claims “cannot contain any bracketing or other indication of what was in the previous version of the [new] claim. This is because all changes in the reissue are made vis-à-vis the original patent, and not in comparison to the prior amendment. Although the presentation of the amended [new] claim does not contain any indication of what is changed from the previous version of the [new] claim, applicant must point out what is changed in the "Remarks" portion of the amendment.” Accordingly, any material to be removed from a new claim is left out of the claim. No bracketing is used for deletion. Applicant is reminded that all new claims must be underlined in their entirety.
Issues Resolved
It is acknowledged that a Certificate of Correction identifying the reissue applications of the ‘850 patent has been filed in prior reissue application Serial No. 18/108,726 (now RE50,527).
The reissue declaration filed 07/29/2026 is accepted. Accordingly, the rejection of claims 67-85 under 35 USC 251 for a defective reissue declaration is moot.
The rejection of claims 71, 74, 81 and 84 under 35 USC 112(b) has been overcome by Applicant’s amendment of the claims.
The non-statutory double patenting rejection of claim 67-85 over claims 1-34 of U.S. Patent No. 10,273,207 (the ‘207 patent) has been overcome by Applicant’s amendment of claims 67 and 77 to require that R37e is optionally substituted heteroaryl. The ‘207 patent claims do not include heteroaryl as a member of the Markush group for R37e.
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 67-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. RE50,527 (the ‘527 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 67-85, the method in claim 33 of the ‘527 patent sets forth, for example, the following compound species wherein R37e is (substituted) aryl or Cl:
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These compounds differ from the instant claims, which require that R37e is optionally substituted heteroaryl. However, claim 33 of the ‘527 patent depends from claim 1, which states that R37e is “H, -OH, fluoro, chloro, bromo, iodo, oxo, methyl, methoxy, heteroaryl or aryl (emphasis added)”.
It would have been obvious to one of ordinary skill in the art to have modified any of the above compound species in claim 33 of the ‘527 patent by replacing the (substituted) aryl or Cl with a heteroaryl group because claim 1 of the ‘527 patent teaches that R37e is selected from a short list that includes heteroaryl. This is a matter of substitution of one R37e group for another to obtain predictable results. The specific heteroaryl groups in instant dependent claims 71, 72, 74, 75, 81, 82, 84 and 85 are conventional heteroaryl groups. In fact, claim 20 of the ‘527 patent shows that R37e can be thiophenyl.
Instant claim 76 further sets forth a pharmaceutical composition containing the compound of claim 67 and a pharmaceutically acceptable carrier. Instant claims 77-85 further set forth a method utilizing said pharmaceutical composition.
However, the method set forth in claim 33 of the ‘527 patent uses the compound, and thus, the above-modified compound, to treat a cancer mediated by a K-Ras (i.e., KRAS) G12C, H-Ras G12C or N-Ras G12C mutation. The method in claim 33 of the ‘527 patent inherently binds the cysteine 12 residue of a KRAS G12C protein because the ‘527 patent specification teaches that “the compounds of the invention selectively react with the G12C mutant K-Ras, H-Ras or N-Ras proteins by forming an irreversible covalent bond with the cysteine at the 12 position.” (See col. ¶ bridging cols. 20-21).
The method in claim 33 of the ‘527 patent does not specifically teach that the patient is a human. However, it is well known that humans can suffer from KRAS G12C-mutated cancer. Accordingly, it would have been obvious to one of ordinary skill in the art to perform the cancer treatment method in claim 33 of the ‘527 patent on a human subject because humans are known to suffer from KRAS G12C-mutated cancer.
It further would have been obvious to one of ordinary skill in the art to have administered the above-modified compound of claim 33 of the ‘527 patent with a pharmaceutically acceptable carrier, i.e., as a pharmaceutical composition as here claimed, because a pharmaceutically acceptable carrier is conventional in the art when administering a compound for treatment of cancer.
Accordingly, instant claims 67-85 are rendered obvious by the claims of the ‘527 patent.
Response to Arguments
Applicant's arguments filed July 29, 2026 have been fully considered but they are not persuasive.
With respect to the non-statutory double patenting rejection over the claims of the ‘527 patent, Applicant argues that R37e has been amended to be defined as an optionally substituted heteroaryl, whereas claim 33 of the ‘527 patent does not include species in which R37e is defined as heteroaryl (Remarks, p. 10).
This argument is unpersuasive because, as noted above in the rejection, it would have been obvious to modify the compound species in claim 33 of the ‘527 patent to have a heteroaryl for R37e since parent claim 1 of the ’527 patent teaches that R37e can be heteroaryl in a short list of suitable groups.
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 proceed-ing in which Patent No. 10,919,850 is or was involved. These proceedings would include interferences, reissues, reexaminations, 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 mate-rial to patentability of the claims under consideration in this reissue appli-cation. 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
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached on 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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