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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 6, 2026 has been entered.
Claims Status and Response to Amendments
The amendments filed March 6, 2026, have been acknowledged and entered. Claims 1, 11-15, 18-20, 22-23, 25 and 28-29 are pending.
Priority
This application is a 371 of PCT/CN2020/116510, filed September 21, 2020.
Acknowledgment is made of applicant's claim for foreign priority based on the CN201910892032.X application filed in China on September 20, 2019; the CN201911129688.2 application filed in China on November 18, 2019; the CN201911157939.8 application filed in China on November 22, 2019; the CN202010054188.3 application filed in China on January 17, 2020; the CN202010967317.8 application filed in China on September 15, 2020; the CN202010230303.8 application filed in China on March 27, 2020; the CN202010306926.9 application filed in China on April 17, 2020; the CN202010367694.8 application filed in China on April 30. 2020, and the CN202010102546.3 application filed in China on February 19, 2020. Receipt is acknowledged of the certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Examiner acknowledges that Applicant states they have submitted English translations of the Chinese priority documents with the current response (see page 2 of remarks filed March 6, 2026); however, the English translations submitted are not certified English translations. Examiner further notes that the documents are not labeled with a corresponding CN application number and therefore it is not possible to identify which translation corresponds to which priority document.
The effective filing date of the instant claims is thus September 21, 2020.
Election/Restriction
The present examination is based on Applicant’s election with traverse of Group I, presently claims 1, 11-15, 18-20, 22-23, 25 and 28-29 and species of Formula (I-B) in the reply filed June 17, 2024. The traversal was found unpersuasive for the reasons set forth in the previous Office Action mailed May 19, 2025 and was made FINAL.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant' s amendments and/or
remarks.
Claim Objections
Claim 18 is objected to for the following minor informalities: the claims recites
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. The claim should be amended to insert “or” between structures
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and
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Claim 29 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.
The statement of reasons for indicating allowable subject matter is provided below (see Allowable Subject Matter).
Claim Rejections - 35 USC § 112b
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.
Claim 1, 11-15, 18-20, 22-23, 25 and 28 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. The claims are indefinite for the reason that follow:
Claim 1 recites the limitation “X1 is .. -C(R7)2-”; however, the claims have been amended to cancel the definitions of R7. The scope of R7 is therefore unclear and one skilled in the art cannot ascertain the metes and bounds of the invention. It is suggested that Applicant amend the claim to include definitions of R7 for which Applicant has written support.
Claims 11-15, 18-19 and 22 depend from claim 1, include the abovementioned deficiency regarding R7, and therefore are also indefinite for the same reason.
Claim 25 is an independent claim that also recites the limitation “X1 is .. -C(R7)2-” but does not provide a definition of R7. The claim is indefinite for the reasons provided above regarding claim 1.
Claim 19 recites limitations
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. There is insufficient antecedent basis for these limitations in the claim because claim 19 depends from claim 18, which depends from claim 1, and the claims have been amended to delete wherein alkyl may be substituted with heterocycloalkyl. Claim 1 recites R6 is selected from C1-6 alkyl, C1-6 alkyl-S(=O)2-, 3-6 membered heterocycloalkyl and C3-6 cycloalkyl-C(=O)-, wherein the C1-6 alkyl is substituted by 1, 2, or 3
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. Claim 18 provides narrower limitations of claim 1. None of the definitions of R6 recited in the base claims provide support for the abovementioned limitations of claim 19. It is suggested the base claims 1 and 18 should be amended to provide support for all limitations of claim 19.
Claim 20 recites the limitation “X2 is…
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”. Claim 1 defines X2 as -N(R6)2-. There is insufficient antecedent basis for this limitation of X2 for the reasons provided above regarding claim 19. It is suggested the base claims 1 and 18 should be amended to provide support for all limitations of claim 20.
Claim 23 and 28 provide formulae wherein X1 is -C(R7)2 - and R7 is hydrogen. There is insufficient antecedent basis for this limitation for the reasons that claims 23 and 28 depend from claim 1 and do not teach that R7 is hydrogen. It is suggested the base claims 1 should be amended to provide support for R7.
Claim 28 recites compound
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(see page 16 of 36 in the reply; final row, middle compound). There is insufficient antecedent basis for this compound in the claim because claim 28 depends from claim 1 which provides that R5 is optionally substituted by 1 or 2 C1-2 alkyl. The compound above requires R5 to be substituted with two alkyl groups and an amino group which is not supported by the base claim.
Claim 28 recites compound
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(final compound in claim 28). There is insufficient antecedent basis for this compound in the claim because claim 28 depends from claim 1 which provides that R10 is H. The compound above requires R10 to be halogen which is not supported by the base claim.
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)(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.
Claim(s) 1, 11-15, 18-19, 22 and 25 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhou et al. (US 12,054,497 B2; effectively filed October 30, 2019)
Zhou teaches compounds Z152 (col 128, pictured below for convenience) which corresponds to instant Formula (I-B) wherein A is a C6 aryl; n is 2 and R4 is -OH and halogen (F); T1 and T2 are each -C(R8)- where R8 is halogen (Cl or F); R5 is 6 membered heteroaryl (pyrimidinyl) substituted with two C1-6 alkyl (isopropyl); X1 is -C(=O)-; X2 is -N(R6) wherein R6 is C2 alkyl substituted with
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; Y is N; m is 0 (R3 is absent) ; L1 is -C(=O)-; each of R1, R2 and R10 is H;
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and
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.
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Regarding claim 11, Zhou teaches wherein R4 is OH and F (see compound Z152 above).
Regarding claim 12, Zhou teaches wherein ring A is phenyl (see compound Z152 above).
Regarding claim 13, Zhou teaches wherein
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is
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(see compound Z152 above).
Regarding claim 14, Zhou teaches wherein R5 is pyrimidinyl substituted with two C1-6 alkyl (two isopropyl) (see compound Z152 above).
Regarding claim 15, Zhou teaches wherein R5 is
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(see compound Z152 above).
Regarding claims 18, Zhou teaches wherein R6 is C2 alkyl substituted with
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.
Regarding claim 19, Zhou teaches wherein X2 is
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(see compound Z152 above)
Regarding claim 22, Zhou teaches wherein R8 is F or Cl (see compound Z152 above).
Regarding claim 25, Zhou teaches a pharmaceutical composition comprising Z152 (Abstract).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 11-15, 18-19, 22, 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (US 12,054,497 B2; effectively filed October 30, 2019).
Zhou teaches a generic group of compounds which embraces Applicants’ claimed compounds (See col 1-7) for use as pharmaceuticals and compositions for the treatment of cancer (see Abstract). The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the instant application to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).”
Regarding claim 1 and 25, Zhou teaches compound Z10 (cols 84, pictured below for convenience) and a composition thereof (Abstract) which corresponds to instant Formula (I-B) wherein A is a C6 aryl; n is 2 and R4 is -OH and halogen (F); T1 is N; T2 is -C(R8)- where R8 is halogen (F); R5 is 6 membered heteroaryl (pyridinyl) substituted with two C1-6 alkyl (methyl and isopropyl); X1 is -C(=O)-; X2 is -N(R6) wherein the position corresponding to R6 is C1 alkyl; Y is N; R3 is C1 alkyl and m is 1; L1 is -C(=O)-; each of R1, R2 and R10 is H;
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and
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.
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Regarding claim 11, Zhou teaches wherein R4 is OH and F (see compound Z10 above).
Regarding claim 12, Zhou teaches wherein ring A is phenyl (see compound Z10 above).
Regarding claim 13, Zhou teaches wherein
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is
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(see compound Z10 above).
Regarding claim 14, Zhou teaches wherein R5 is pyridinyl substituted with two C1-6 alkyl (methyl and isopropyl) (see compound Z10 above).
Regarding claim 15, Zhou teaches wherein R5 is
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(see compound Z10 above).
Regarding claims 18-19, Zhou teaches wherein the position corresponding to R6 is can be a C1-6 alkyl substituted with F or -OCH3 (see compound Z10 above; Zhou teaches “halogen” includes F, see col 208, lines 55-60).
Regarding claim 22, Zhou teaches wherein R8 is F (see compound Z10 above).
Regarding claim 28, Zhou teaches compound Z10 and wherein the position corresponding to R6 of the claims can be C1 alkyl substituted with halogen which includes F. Zhou thus teaches the position corresponding to R6 can be -CF3 (see col 7, lines 15-25: In Formula I-1, P is NRm wherein Rm is halogenated C1-6 alkyl)
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Zhou does not disclose a compound wherein the position corresponding to R6 of the claims is a C1-6 alkyl substituted with halogen, -OCH3, or -CN as required by the claims. However, Zhou further teaches a genus of compound I-1 (col 6, pictured above) which provides that the position corresponding to R6 of the claims can be a C1 alkyl or C1-6 alkyl group substituted with a halogen, -OCH3, or -CN as required by the claims (see col 7, lines 15-25: In Formula I-1, P is NRm wherein Rm is halogenated C1-6 alkyl, C1-6 alkyl-cyano, C1-6 alkyl-alkoxy). Zhou therefore teaches the equivalence of C1 alkyl and a C1-6 alkyl group substituted with a halogen, -OCH3, or -CN at the position of R6 of the instant claims.
The difference between the prior art and the instant claims is that the instant claims require that R6 is C1-6 alkyl group substituted with a halogen, -OCH3, or -CN. However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant claims to modify the position corresponding to R6 of compound Z10 with a C1-6 alkyl group substituted with a halogen, -OCH3, or -CN, as is required by the instant claims, because Zhou had disclosed that C1 alkyl and C1-6 alkyl group substituted with a halogen, -OCH3, or -CN where equivalent groups at the position corresponding to R6 of the instant claims.
One would have been motivated as a matter of making additional compounds to treat cancer. One would have been especially motivated to make modifications to compound Z10 that the reference explicitly taught, which in the present case includes wherein the position corresponding to R6 can alternatively be C1 alkyl and C1-6 alkyl group substituted with a halogen, -OCH3, or -CN.
One would have had a reasonable expectation of success because Zhou had already disclosed the claimed modifications and that C1 alkyl and C1-6 alkyl group substituted with a halogen, -OCH3, or -CN where equivalent groups at the position corresponding to R6 of the instant claims. Therefore there would have been an expectation that such a modification would result in a compound useful for treating cancer.
Response to Arguments
Applicant’s arguments filed March 6, 2026 have been fully considered but they are not persuasive.
Applicant argues that the instant application is entitled to an earlier effective filing date for the claimed invention than is Zhou (page 34 of 36 of reply). Applicant states they submit herewith an English translation of PD6 (CN 202010230303.8) for the instant application. Support for the claimed invention can be found in Applicant's PD6, filed March 27, 2020. Applicant's priority document, CN 202010230303.8, filed March 27, 2020 has clear support for compounds having the R6 = aminoalkyl. Thus, the instant claims are entitled to PD6's filing date (March 27, 2020), which predates Zhou's PCT filing date (October 28, 2020) (page 35 of 36 of reply).
This argument is not found persuasive because the priority documents that have been filed by Applicant are not certified and have no identifiable markings. Of the 9 translations submitted, none of which is certified, it is not clear which is intended to correspond to the abovementioned PD6 document since none of the documents has an application number corresponding to a priority document. Applicant therefore is not given the benefit of foreign priority. The effective filing date of the claims is September 21, 2020 and Zhou (effectively filed October 19, 2019) is prior art to the instant claims. The rejection over Zhou is still deemed proper and maintained.
Should applicant desire to obtain the benefit of foreign priority, a certified English translation of the foreign application must be submitted in reply to this action.
Allowable Subject Matter
Claim 20 and 23 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 29 is objected to as indicated above but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest reference to the instant claims is Zhou et al. (US 12,054,497 B2), the teachings of which were discussed in the rejection above and are incorporated herein by reference. The difference between Zhou and the instant claims is that the instant claims require that R6 is a an alkyl substituted with an amino group and X1 is CH2 (claim 20) or that R6 is a an alkyl substituted with an amino group, R3 is alkyl and X1 is CH2 or -C(=O)- (claims 23 and 29) . Zhou is silent regarding the combination of R6, R3 and X1 that are required by the claimed invention. There is no teaching which would have motivated a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou into the claimed invention with any reasonable expectation of success.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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April 11, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
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