DETAILED ACTION
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Examiner have withdrawn all previous 112 and 102 rejections.
The Examiner extended the Markush search to
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wherein
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, R2
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; R0 is
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(cyclopropyl); R3 is CH3; and R1 is
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Examiner interprets this prodrug or metabolite of genus formula I of instant claims 1, 6, 12 and 14, which retrieved prior art. Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species of prodrugs or metabolites of genus formula I of instant claims 1, 6, 12 and 14.
New double patenting and 102 rejections are made due to Markush search extension.
Claim 1-6 and 8-23 are examined in this office action.
Current Status of 18/046,879
This Office Action is in response to the amended claims of 03/04/2026.
Claims 10, and 16-17 are original; 1-6, 8-9,12-15 and 18 are currently amended; and claims 11 and 18-23 were previously presented.
Claims 1-6 and 8-23 are examined in this office action.
Priority
Effective filing date is 04/16/2021, claims find support on PCT/CN2021/087912.
Acknowledgment is made of applicant's claim for foreign priority.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 03/04/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks 03/04/2026. Examiner have reviewed these remarks and amendments.
Regarding 112 rejections, applicant amended claim 1 to specify the definition of R1, thus overcoming 112 rejection. Therefore 112 rejection is withdrawn.
Regarding 102 rejection, applicant amended claim 1 to include the proviso R1- is not cyclopentyl, thus overcoming the rejection. Thus the 35 U.S.C. 102 rejection is withdrawn.
Response to Amendments
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 1-6 and 8-23 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.
The term “prodrug” is not defined by claims 1-6 and 8-23. The specification does not provide definition of the term “prodrug”. One of ordinary skill in the art could not reasonably determine the scope of the term “prodrug” (see Zawilska et.al. Pharmacological Reports, 2013, 65, Page 1-14). As drafted “prodrug” in claim 1-6 and 8-23 renders the metes and bounds of claims 1-6 and 8-23 indefinite.
The term “metabolite” is not defined by claims 1-6 and 8-23. The specification does not provide definition of the term “metabolite”. One of ordinary skill in the art could not reasonably determine the scope of the term “metabolite” (see Goodman et.al. The Pharmacological Basis of Therapeutics May 19th 1992)). As drafted “metabolite” in claim 1-6 and 8-23 renders the metes and bounds of claims 1-6 and 8-23 indefinite.
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).
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.
Claim(s) 1-6 and 8-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BORCHARDT ALLEN J (WO-2007015877-A2).
Borchardt et.al discloses the compound
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(claims 18-19) and therapeutical acceptable salt (page 17 lines 20-30) corresponds to compound of formula (I) (instant claim 1) and formula (I’) (claim 12) formula (I”) (claim 14) wherein
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R2 is -C(=O)NR2aR2b wherein R2a is H and R2b is
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(3 membered cycloalkyl); R0 is cyclopropyl; and R1 is
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. Compound
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is interpreted as prodrug and/or metabolite (using BRI) of compound of formula I because the core structure, as shown with the circle
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is same as formula I. Furthermore, the specification do not define the terms prodrug and metabolite, thus anticipating claims 1-5 and 11. Borchardt further discloses composition with additional therapeutic agent (claim 21) anticipating claim 10.
Compound
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is interpreted as prodrug and metabolite (using BRI) of compound of formula IV
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because the core structure, as shown with the circle
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is same as formula IV, thus anticipating claims 6 and 8.
Compound
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(claims 18-19) and therapeutical acceptable salt (page 17 lines 20-30) is interpreted as prodrug and metabolite (using BRI) of compound of formula (I’)
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because the core structure, as shown with the circle
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is same as formula (I’), and the specification do not define the terms prodrug and metabolite, thus anticipating claims 12-13.
Compound
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(claims 18-19) and therapeutical acceptable salt (page 17 lines 20-30) is interpreted as prodrug and metabolite(using BRI) of compound of formula (I’)
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because the core structure, as shown with the circle
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is same as formula (I’) and the specification do not define the terms prodrug and metabolites, . Borchardt further discloses composition with additional therapeutic agent (claim 21) anticipating claims 14-15 and 17-18.
Compound
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(claims 18-19) and therapeutical acceptable salt (page 17 lines 20-30) is interpreted as prodrug and metabolite (using BRI) of all the compounds in claims 9, 16, and 18-23 because the core structure, as shown with the circle
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is same. The specification do not define the term prodrug and metabolite, thus anticipating claims 9, 16, and 18-23.
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).
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 1-6, 8-11, 19 and 21 provisionally rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1 and 14-16 of copending Application No18/694,646 (reference application). Instant claims of 03/04/2026 was used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1 discloses compound
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sames as claims 9, 19 and 21, wherein
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, R2 is CO2NH2 and F; R0 is CH2CH3; and R1 is
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same as claims 1-6 and 8-9. Reference claims 14 recites pharmaceutical composition comprising of crystalline form and a pharmaceutically acceptable carrier or excipient same as instant claim 10 which recites pharmaceutical composition of the compound, thus anticipating claim 10. Reference claim 15-16 discloses method of treating cancer with the compound same as instant claim 11.
Claims 1-6 and 8-23 provisionally rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 13-32 of copending Application No18/996,486 (reference application). Instant claims of 03/04/2026 was used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because underlining compounds in reference claims 13-20 and 22 discloses compound
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same as claims 9, 19 and 21, wherein
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, R2 is CO2NH2 and F; R0 is CH2CH3; and R1 is
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same as instant claims 1-6 and 8-9. Reference claims 13-20 and 25 disclose the compound
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same as instant claims 19 and 13. Reference claims 13-20 and 20 discloses the compound
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same as instant claim 22. Reference claims 13-20 and 23 teaches the compound
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same as instant claims 1-6, 8-9 and 19-20. Reference 13 discloses compound
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where C in
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is pyrimidine thus same as claims 1-6, 8-9 and 12-16. Reference claims 13-15 discloses compound
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of instant claims 1-6, 8-9 and 23.
Reference claims 13-32 discloses pharmaceutical composition with compound of formula I same as instant claim 10 and 17. Reference claims 13-32 discloses method of treating cancer with compound of formula I same as instant claims 11 and 18.
Claims 1-6 and 8-23 provisionally rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1-6 and 8-20 of copending Application No18/993,376 (reference application). Instant claims of 03/04/2026 was used for this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because underlining compounds in reference claims 1-6, 8-9 and 12 discloses compound
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same as claims 9, 19 and 21, wherein
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, R2 is CO2NH2 and F; R0 is CH2CH3; and R1 is
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same as claims 1-6 and 8-9. Reference claims 1-6, 8-9 and 15 disclose the compound
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same as instant claims 19 and 13. Reference claims 1-6, 8-9 discloses the compound
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same as instant claims 22. Reference claims 1-6, 8-9 teaches the compound
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same as instant claims 9 and 19-20. Reference claims 1-6 and 8-9 teaches compound
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where C in
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is pyridyl group, same as instant claims 1-6 8-9, 12-16. Reference claims 1-6, 8-9 and 20 discloses compound
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of instant claim 23.
Reference claims 1-6 and 8-20 discloses pharmaceutical composition with compound of formula I same as instant claims 10 and 17. Reference claims 1-6 and 8-20 discloses method of treating cancer with compound of formula I same as instant claims 11 and 18.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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).
Conclusion
No claims are allowable as written.
Applicants are encouraged to strike metabolite and prodrug from the claims to advance prosecution.
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 Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.I./Examiner, Art Unit 1625
/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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