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
Status of the Claims
Claims 1-23 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on May 5th 2025, February 13th 2024, and February 12th 2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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.
Claims 13, 21, and 23 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.
Claim 13 is indefinite for failing to further limit the compound of claim 10, upon which it depends. Claim 13 recites “The compound of claim 10, wherein the saturated bicyclic ring system of claim 5 is optionally substituted with an alkyl, cyanoalkyl or halogen.” Regarding these limitations, claim 10 recites:
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while claim 5 recites:
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Nowhere in claim 5 is a “saturated bicyclic ring system” recited. It is unclear what further limitation to claim 10 was intended with the phrase, “wherein the saturated bicyclic ring system of claim 5 is optionally substituted with an alkyl, cyanoalkyl or halogen.” Claim 13 is therefore not further limiting to claim 10 and is indefinite.
Claims 21 and 23 are indefinite for the phrase “a KRas G12C-associated cancer,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claims from the claim language. Specifically, the term “KRas G12C-associated” is not defined in the specification further than, “associated with or mediated by or having a KRas G12C mutation.” While the particular subset of “cancers having a KRas G12C mutation,” would be recognized by one of ordinary skill in the art, the term “cancers associated with or mediated by a KRas G12C mutation,” is unclear, as one of ordinary skill in the art could not reasonably determine if a cancer is “associated with” or “mediated by” a KRas G12C mutation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim recites ‘A method for inhibiting KRas G12C activity in a cell, comprising contacting the cell in which inhibition of KRas G12C activity is desired with an effective amount of a compound of Formula (I).’ This judicial exception is not integrated into a practical application because only the contacting of the cell with the compound (i.e. a natural phenomenon) and the intended result of the contact (the inhibition of KRas G12C) is recited. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the natural phenomenon and its intended result are recited.
Nonstatutory 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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,633,381 in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). The reference patent teaches KRAS G12C including the compound,
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which differs from the instant compound genus,
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only in the bioisosteric replacement of a pyrimidine ring with a pyridine ring (see C=C in the Y location) or thiazole (see S in the Y location). As both the replacement of pyrimidine with pyridine (Brown, pg. 61) and the replacement of pyridine with thiazole (Brown, pg. 118) are known bioisosteric replacements in the field of drug discovery, the instant claims are obvious over the reference patent.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,125,134 in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). The reference patent teaches KRAS G12C including the compound,
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which differs from the instant compound genus,
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only in the bioisosteric replacement of a pyrimidine ring with a pyridine ring (see C=C in the Y location) or thiazole (see S in the Y location). As both the replacement of pyrimidine with pyridine (Brown, pg. 61) and the replacement of pyridine with thiazole (Brown, pg. 118) are known bioisosteric replacements in the field of drug discovery, the instant claims are obvious over the reference patent.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11,267,812 in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). The reference patent teaches KRAS G12C including the compound,
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which differs from the instant compound genus,
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only in the bioisosteric replacement of a pyrimidine ring with a pyridine ring (see C=C in the Y location) or thiazole (see S in the Y location). As both the replacement of pyrimidine with pyridine (Brown, pg. 61) and the replacement of pyridine with thiazole (Brown, pg. 118) are known bioisosteric replacements in the field of drug discovery, the instant claims are obvious over the reference patent.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,548,888 in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). The reference patent teaches KRAS G12C including the compound,
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which differs from the instant compound genus,
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only in the bioisosteric replacement of a pyrimidine ring with a pyridine ring (see C=C in the Y location) or thiazole (see S in the Y location). As both the replacement of pyrimidine with pyridine (Brown, pg. 61) and the replacement of pyridine with thiazole (Brown, pg. 118) are known bioisosteric replacements in the field of drug discovery, the instant claims are obvious over the reference patent.
Allowable Subject Matter
Claim 14 is free of the prior art.
Applicant has developed KRAS G12C inhibitors of the genus,
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These compounds are useful in the treatment of cancers. While applicant’s compound genus is obvious over several of applicant’s other patents and applications (see the above nonstatutory double patenting rejections), applicant’s embodied compounds, as described in claim 14, are free of the art and could not have been predicted to one of ordinary skill in the art.
Claim 14 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629