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 1-12, 14-20, and 22 are pending and are examined on their merits.
35 U.S.C. § 101 Rejections Maintained
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.
Applicant’s arguments in the response filed on April 10th 2026 are acknowledged. Applicant argues that the instant compounds are not natural products and thus claim 16 cannot be classified as a natural phenomenon. Applicant’s arguments are found not persuasive.
Claim 16, as written, reads:
“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) or a pharmaceutically acceptable salt thereof according to claim 1.”
The natural phenomenon in question is the natural correlation between KRas G12C inhibition and the contact of the cell with the compound.
Applicant’s argument equates to an argument that the presence of the “compound of Formula (I)” adds significantly more. In said context, applicant’s claim is not directed towards a practical application or improvement (for example, a method of treatment), but only the contacting of the cells with the compound and the results of said contact, (i.e. an in vitro cell study relating to the contact of the cell with the compound and observation of results).
35 U.S.C. § 101 Rejections Reiterated
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 Rejections Maintained
Applicant’s arguments in the response filed on April 10th 2026 are acknowledged. Applicant argues that bioisosterism does not lead to a determination of prima facie obviousness.
As support, applicant first cites Ex parte Donde, Appeal 2009-12378, a nonprecedential court decision (thus decided on the merits of the fact pattern of the case, distinct from the fact pattern of the instant claims). Said court decision does not serve as legal precedent for the instant application.
Applicant additionally cites Mitsubishi v. Sandoz, where the court found that the claim that the series of modifications necessary to develop canagliflozin from dapagliflozin was obvious was not supported by the evidence of record. The case hinged on the specific landscape of prior art relevant to the SGLT2 inhibitors. Such a case does not create a blanket rule that bioisostere arguments cannot be used in obviousness rejections, but only that they must serve the specific fact patterns of the case. In the present instance, such compounds are found to have a close structural similarity (see below) and close functional similarity. See MPEP 2144.09(I) and MPEP 2144.09(III):
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
See also In re Mayne, 104 F.3d 1339, 41 USPQ2d 1451 (Fed. Cir. 1997) (claimed protein was held to be obvious in light of structural similarities to the prior art, including known structural and functional similarity of the amino acids leucine and isoleucine); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (claimed and prior art compounds used in a method of treating depression would have been expected to have similar activity because the structural difference between the compounds involved a known bioisosteric replacement); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (The tri-orthoester fuel compositions of the prior art and the claimed tetra-orthoester fuel compositions would have been expected to have similar properties based on close structural and chemical similarity between the orthoesters and the fact that both the prior art and applicant used the orthoesters as fuel additives.) (See MPEP § 2144 for a more detailed discussion of the facts in the Dillon case.).
The rejections here are not an argument of bioisosterism alone, but in the context of the four relevant disclosures of U.S. Patent No. 10,633,381, 10,125,134, 11,267,812, and 11,548,888. In the context of the structural/functional similarities demonstrated below, and with no evidence provided of relevant secondary considerations, applicant’s arguments are found not persuasive and the nonstatutory double patenting rejections are maintained.
Nonstatutory Double Patenting Rejections Reiterated
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 1-12, 14-20, and 22 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 1-12, 14-20, and 22 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 1-12, 14-20, and 22 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 1-12, 14-20, and 22 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
THIS ACTION IS MADE FINAL. 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.
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
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