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
Claims 1, 3, 5-9, 11-21, 25-27, 29, 30, 32, 34, 36, 38 and 39 are pending in the application. Claims 1, 3, 5-9, 11-21, 25-27, 29, 30, 34, 36, 38 and 39 are rejected. Claim 32 is allowed.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on January 30th, 2026.
Response to Amendment / Argument
The amendment to the claims filed on January 30th, 2026 does not comply with the requirements of 37 CFR 1.121(c) because the amendments to claims 9, 11 and 17 were not clearly marked since previously presented structures are missing but not labeled with strikethrough. Furthermore, sections of claims 9 and 11 appear to be both underlined and struckthrough. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Nevertheless, the amendment has been treated on the merits.
On page 36 of the response filed January 30th, 2026, Applicant traverses the Examiner’s position on priority and asserts that paragraph 20 of the ‘132 application “recites multiple A rings containing a cyanoC1-C3alkyl group.” The cited section only contains one structural backbone and it is only substituted by a cyanoC1alkyl group. There is no disclosure of cyanoC2-C3 alkyl groups. Furthermore, the subgeneric structures of paragraph [0020] do not support broadening the generic disclosure to permit substitution on the various additional types of A rings besides piperazine. Applicant does not appear to address the option for R5 to be substituted by “heteroarylC1-C3alkyl,” which issue is reiterated below. Accordingly, Applicant’s traversal on priority and the corresponding rejection under 35 USC 102(a)(2) based on lack of priority is not found persuasive.
All other objections and rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims. Therefore, arguments pertaining to these objections and rejections will not be addressed.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on January 30th, 2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed application, Application No. 63/351,132 and 63/482,726, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The disclosure of the ‘132 application fails to provide support for:
The option for “A” to be substituted by “cyanoC1-C3alkyl”;
The heteroarylC1-C3alkyl substituent options in the definition of R5;
The species beyond the first thirteen of instant claim 32.
Since the differences above affect the scope of instant claims 1, 5-9, 11-21, 25-27, 29, 30, 32, 34, 36, 38 and 39 these claims are not afforded the filing date of the ‘132 application.
The disclosure of the ‘726 application fails to provide support for:
The heteroarylC1-C3alkyl substituent option in the definition of R5; and
The species found on Applicant labeled pages 25-40 of the claim set dated September 28th, 2023.
Since the differences above affect the scope of instant claims 1, 5-9, 11-16, 21, 25-27, 29, 30, 32, 34, 36, 38 and 39, these claims are not afforded the filing date of the ‘132 application.
Furthermore, claims 1, 3, 5-7, 12-21, 25-27, 29, 30, 34, 36, 38 and 39 are rejected for containing new matter and lack priority relative to the provisional applications for the same reasons as discussed under 35 USC 112(a). Accordingly, the earliest effective filing date of these claims is January 30th, 2026, i.e. when the subject matter first appears in the instant application.
The earliest effective filing dates are therefore:
January 30th, 2026: Claims 1, 3, 5-7, 12-21, 25-27, 29, 30, 34, 36, 38 and 39;
June 8th, 2023; Claims 8, 9, 11 and 32.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-7, 12-21, 25-27, 29, 30, 34, 36, 38 and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to change the definition of ring A as follows:
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Claim 1 (and various dependent claims) were previously rejected as indefinite since it was unclear which of the following interpretations applied to claim 1:
“A” must contain one nitrogen heteroatom and can optionally further contain two additional heteroatoms independents selected from nitrogen, oxygen, and sulfur;
“A” must contain one nitrogen heteroatom and the ring can contain one additional heteroatom selected from nitrogen, oxygen, and sulfur;
“A” need not contain any heteroatoms but when it does, it contains up to two heteroatoms selected from nitrogen, oxygen, and sulfur; and
“A” must contain one or two heteroatoms and each is independently selected from nitrogen, oxygen, and sulfur.
Applicant has amended the claim to conform to interpretation (1); however, interpretation (1) is broader than additional possible interpretations and the specification does not clarify which possible interpretation was originally intended, i.e. why a person having ordinary skill in the art would recognize interpretation (1) to be correct. MPEP 2163.07(II) notes: “An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of error in the specification, but also the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).” In this situation, interpretation (2) appears to be the broadest definition that would be supported by the original disclosure since, for instance, no examples are disclosed containing three heteroatoms (as permitted by interpretation (1) and amended claim 1) and no examples are disclosed lacking a nitrogen heteroatom (as permitted by interpretations (3) and (4)).
Since the difference in scope affects instant claims 1, 3, 5-7, 12-21, 25-27, 29, 30, 34, 36, 38 and 39 these claims are each rejected for containing new matter.
Claims 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 17 has been amended to replace the following option for R5:
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with the following option:
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Applicant does not state in the remarks filed January 30th, 2026 where support can be found for this amendment. The original structure provides for a definition of R5 that would correspond to R5 itself being C3cycloalkylC1alkyl, which is substituted by a group -CH2NRaRb. The definitions of Ra and Rb, however, are broader in scope than the options listed in original claim 1 that only include substitution by aminoC1alkyl, C1-C6alkylaminoC1alkyl or di(C1-C6alkyl)aminoC1alkyl. The amended claim 17 not provides for the amino group to substituted by alkoxycarbonyl, alkylcarbonyl, arylalkyl, cycloalkyl and cycloalkyl-alkyl groups of different carbon counts.
There do not appear to be any disclosed species or sub-generic disclosures that clarify which definitions were intended for the Rc and Rd positions and the instant amendment provides for definitions even broader than the broadest generic disclosure.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The fourth option provides for a definition of R5 that would correspond to R5 itself being C3cycloalkylC1alkyl, which is substituted by a group -CH2NRaRb. The definitions of Ra and Rb, however, are broader in scope than the options listed in claim 1 that only include substitution by aminoC1alkyl, C1-C6alkylaminoC1alkyl or di(C1-C6alkyl)aminoC1alkyl. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, 8, 12-21, 25-27, 29, 30 and 34 are rejected under 35 U.S.C. 102(a)(2) and claims 1, 3, 5, 12-21, 25-27, 29, 30 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Application Publication No. WO 2024/138206 A1 by Patel et al., which claims priority to U.S. Provisional Application No. 63/435,121, which was filed December 23rd, 2022.
The prior art teaches the following compound on page 279:
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Support for the species above can be found on page 232 of the ‘121 application. The compound is embraced by the instant variables of formula (I) where Z is a bond, R1 is aryl substituted by halo and C2alkynyl, R2 is hydrogen, R3 is halo, X is O, R5 is heterocyclylC1alkyl substituted by halo, Y is a bond, A is a nine-membered nitrogen containing spirocyclic saturated ring system that beyond one nitrogen contains an additional nitrogen and oxygen (Applicant is directed to the rejection under 35 USC 112(b)), U is a bond, R’ is fluoro and R4 is heteroaryl (pyrimidinyl) substituted by C1 alkyl. These definitions are embraced by instant claims 1, 3, 5, 8, 12-21, 25-27, 29 and 30. Regarding instant claim 34, the prior art teaches biological testing in the cited tables that would have involved mixtures with water, which is a pharmaceutically acceptable excipient.
Claims 1, 3, 5-9, 11-21, 25-27, 29, 30 and 34 are rejected under 35 U.S.C. 102(a)(2) and claims 1, 3, 5-7, 12-18, 20, 21, 25-27, 29, 30 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Application Publication No. WO 2024/229444 A2 by Gerken et al., which claims priority to U.S. Provisional Application No. 63/464,170, which was filed May 4th, 2023.
The prior art teaches the following compound on page 165:
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Support for the species above can be found on page 151 of the ‘170 application. The compound above is embraced by the instant variables of formula (I) where Z is a bond, R1 is aryl substituted by halo, R2 is hydrogen, R3 is halo, X is O, R5 is heterocyclylC1alkyl, Y is a bond, A is a 6-membered nitrogen containing saturated ring system that beyond one nitrogen contains an additional nitrogen (Applicant is directed to the rejection under 35 USC 112(b)) and is substituted by cyanoC1alkyl, U is a bond, R’ is fluoro and R4 is heteroaryl (pyrimidinyl) substituted by C1 alkyl. These definitions are embraced by instant claims 1, 3, 5, 8, 9, 11-18, 20, 21, 25-27, 29 and 30. Regarding instant claim 34, the prior art teaches biological testing in the cited tables that would have involved mixtures with water, which is a pharmaceutically acceptable excipient.
As an additional example, the prior art teaches the following compound on page 174:
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Support for the species above can be found on page 160 of the ‘170 application. The compound above is embraced by the instant variables of formula (I) where Z is a bond, R1 is aryl substituted by halo, R2 is hydrogen, R3 is halo, X is O, R5 is heterocyclylC1alkyl substituted by halo, Y is a NRf, Rf is C1 alkyl, A is a 5-membered nitrogen containing saturated ring system, U is a bond, R’ is fluoro and R4 is heteroaryl (pyrimidinyl) substituted by C1 alkyl. These definitions are embraced by instant claims 1, 1, 3, 6-8, 11-21, 25-27, 29 and 30.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 5, 8, 12-21, 25-27, 29, 30, 34, 36, 38 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over International Application Publication No. WO 2024/138206 A1 by Patel et al., which claims priority to U.S. Provisional Application No. 63/435,121, which was filed December 23rd, 2022.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches compositions (abstract) “useful in the treatment and suppression of cancer, for example, useful for treating or suppressing cancers characterized by KRAS G12C.” Support can be found on page 1 of the ‘121 disclosure. As specific types of cancer, the prior art teaches a list including (prior art claim 43) lung, colorectal, pancreatic, cervical and bladder cancers on page 305 and where such cancers are KRAS G12C mediated on page 306 (prior art claim 45). Support can be found on pages 278 and 279 of the ’121 application. As an example of the prior art compounds, The prior art teaches the following compound on page 279:
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Support for the species above can be found on page 232 of the ‘121 application. The compound is embraced by the instant variables of formula (I) where Z is a bond, R1 is aryl substituted by halo and C2alkynyl, R2 is hydrogen, R3 is halo, X is O, R5 is heterocyclylC1alkyl substituted by halo, Y is a bond, A is a nine-membered nitrogen containing spirocyclic saturated ring system that beyond one nitrogen contains an additional nitrogen and oxygen (Applicant is directed to the rejection under 35 USC 112(b)), U is a bond, R’ is fluoro and R4 is heteroaryl (pyrimidinyl) substituted by C1 alkyl. These definitions are embraced by instant claims 1, 3, 5, 8, 12-21, 25-27, 29 and 30. Regarding instant claim 34, the prior art teaches biological testing in the cited tables that would have involved mixtures with water, which is a pharmaceutically acceptable excipient.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1, 3, 5, 8, 12-21, 25-27, 29, 30 and 34 where anticipation is the epitome of obviousness. The prior art does not teach a specific embodiment where the prior art compound above was administered to a subject.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
At least in the interest of determining which prior art example compounds would provide optimum results in the specific types of cancer in the prior art, a person having ordinary skill in the art would have been motivated to administer the example prior art compounds in the specific types of cancer taught by the prior art, which methods would be embraced by instant claims 36, 38 and 39.
Claim(s) 1, 3, 5-9, 11-21, 25-27, 29, 30, 34, 36, 38 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over International Application Publication No. WO 2024/229444 A2 by Gerken et al., which claims priority to U.S. Provisional Application No. 63/464,170, which was filed May 4th, 2023.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches compositions (abstract) “useful in the treatment and suppression of cancer, for example, useful for treating or suppressing cancers characterized by KRAS G12C.” Support can be found on page 1 of the ‘170 disclosure. As specific types of cancer, the prior art teaches a list including (prior art claim 49) lung, colorectal, pancreatic, cervical and bladder cancers on page 199 and where such cancers are KRAS G12C mediated on page 200 (prior art claim 51). Support can be found on pages 216 and 217 of the ’170 application. As an example of the prior art compounds, the prior art teaches the following compound on page 165:
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Support for the species above can be found on page 151 of the ‘170 application. The compound above is embraced by the instant variables of formula (I) where Z is a bond, R1 is aryl substituted by halo, R2 is hydrogen, R3 is halo, X is O, R5 is heterocyclylC1alkyl, Y is a bond, A is a 6-membered nitrogen containing saturated ring system that beyond one nitrogen contains an additional nitrogen (Applicant is directed to the rejection under 35 USC 112(b)) and is substituted by cyanoC1alkyl, U is a bond, R’ is fluoro and R4 is heteroaryl (pyrimidinyl) substituted by C1 alkyl. These definitions are embraced by instant claims 1, 3, 5, 8, 9, 11-18, 20, 21, 25-27, 29 and 30. Regarding instant claim 34, the prior art teaches biological testing in the cited tables that would have involved mixtures with water, which is a pharmaceutically acceptable excipient.
As an additional example, the prior art teaches the following compound on page 174:
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Support for the species above can be found on page 160 of the ‘170 application. The compound above is embraced by the instant variables of formula (I) where Z is a bond, R1 is aryl substituted by halo, R2 is hydrogen, R3 is halo, X is O, R5 is heterocyclylC1alkyl substituted by halo, Y is a NRf, Rf is C1 alkyl, A is a 5-membered nitrogen containing saturated ring system, U is a bond, R’ is fluoro and R4 is heteroaryl (pyrimidinyl) substituted by C1 alkyl. These definitions are embraced by instant claims 1, 1, 3, 6-8, 11-21, 25-27, 29 and 30.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1, 3, 5-9, 11-21, 25-27, 29, 30 and 34 where anticipation is the epitome of obviousness. The prior art does not teach a specific embodiment where the prior art compound above was administered to a subject.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
At least in the interest of determining which prior art example compounds would provide optimum results in the specific types of cancer in the prior art, a person having ordinary skill in the art would have been motivated to administer the example prior art compounds in the specific types of cancer taught by the prior art, which methods would be embraced by instant claims 36, 38 and 39.
Allowable Subject Matter
Claim 32 is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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