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.
Reissue Divisional
It is acknowledged that the specification of the instant reissue application has been amended so as to recite a cross reference to the prior reissue application for the ‘850 patent, i.e., Serial No. 18/109,726. However, the 18/109,726 specification has not been amended so as to recite a cross reference to the instant application. 37 CFR 1.177(a) requires that all multiple reissue applications resulting from a single patent must include as the first sentence of their respective specifications a cross reference to the other reissue application(s). See MPEP also 1451.I. Since the 18/109,726 application has issued as a reissue patent, it is requested that the amendment to the 18/109,726 specification be taken care of by Applicant by Certificate of Correction.
The Certificate of Correction for 18/109,726 should state: “Notice: More than one reissue application has been filed for the reissue of Patent No. 10,919,850. The reissue applications are application number 18/109,726 (now RE50,527), and application number 18/237,891, which is a divisional reissue application.”
Reissue Declaration and 35 USC 251
The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The reissue declaration is defective. The identified error is that compounds of formula (VI) in claim 1 of the ‘850 patent do not encompass compounds of formula (V) in which R1 is heteroaryl and L1 is heteroalkylene, heterocycloalkylene, heteroarylene, heteroalkylenecarbonyl, heterocycloalkylenecarbonyl or heteroarylenecarbony, is not an error being correct by the instant reissue application. This error statement is defective because the reissue claims in the amendment filed 08/19/2025 are not directed to compounds of formula (V), but rather are directed to compounds within the scope of formula (VI).
Also, since the instant reissue application is a broadening reissue application, the error statement in the reissue declaration must identify an original claim, e.g., claim 1, that the application seeks to broaden and identify a single word, phrase, or expression in the original claim, and how it renders the original patent wholly or partly inoperative or invalid. Note that identification of R1 and L1 is inappropriate as these are not present in original claim 1.
A new reissue declaration with a sufficient error statement identifying the error is required. An exemplary error statement is as follows:
This is a broadening reissue application. Claim 1 is to be broadened. Claim 1 is unduly narrow since it is limited to a “method”. The reissue application presents claims directed to a compound.
Claims 67-85 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the reissue declaration is set forth in the discussion above in this Office action.
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.
Claims 71, 74, 81 and 84 are 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.
Claims 71, 74, 81 and 84 are indefinite because they each present a Markush group, but the members of the Markush groups are not separated by the word “and” so as to clearly set forth the selection. It is suggested that the word “and” be inserted between the last two members of the Markush group in each of claims 71, 74, 81 and 84.
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 claims 67-75, the method in claim 33 of the ‘527 patent sets numerous compound species, such as those set forth below, that anticipate the claimed compound:
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Accordingly, claims 67-75 are anticipated by claim 33 of the ‘527 patent.
Instant claim 76 sets forth a pharmaceutical composition containing the compound of claim 67 and a pharmaceutically acceptable carrier. Instant claims 77-85 set forth a method utilizing said pharmaceutical composition.
However, the method set forth in claim 33 of the ‘527 patent uses the 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 method in claim 33 treats a cancer mediated by KRAS G12C using the same compound as here claimed.
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 compound in 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, claims 76-85 are rendered obvious by claim 33 of the ‘527 patent.
Claims 67-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,273,207 (the ‘207 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to claims 67-75, claim 33 of the ‘207 patent sets numerous compound species, such as those set forth below, that anticipate the claimed compound:
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Accordingly, claims 67-75 are anticipated by claim 33 of the ‘207 patent.
With respect to claims 76-85, claim 33 differs from the instant claims in not teaching a pharmaceutically acceptable carrier with the compound, and not teaching a method of administering the compound to a human subject so as to covalently bind the cysteine 12 residue of a KRAS G12C protein in a human subject with a KRAS G12C-mutated cancer in the subject.
However, the ‘207 patent specification teaches that a contemplated utility for the compound is for treating KRAS G12C-mutated cancer in human patients, wherein the compound selectively reacts with the G12C mutant KRAS protein by forming an irreversible covalent bond with the cysteine at the 12 position (see, e.g., col. 1, lines 7-28; col. 2, lines 32-52; ¶ bridging cols. 20-21; col. 222, line 59 through col. 223, line 3).
It would have been obvious to one of ordinary skill in the art to have administered the compound in claim 33 of the ‘207 patent to a human subject with a KRAS G12C-mutated cancer so as to covalently bind the cysteine 12 residue of the KRAS G12C protein and thus, treat the subject, because such is a contemplated utility of the compound, as taught by the ‘207 patent specification. See MPEP 804.II.B.1.
It further would have been obvious to one of ordinary skill in the art to have administered the compound in claim 33 of the ‘207 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, claims 76-85 are rendered obvious by claim 33 of the ‘207 patent.
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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferee:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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