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
Applicant cancelled all the claims of 06/15/2023 used for writing restriction/election of species. Since applicant cancelled all the claims, the restriction requirement is moot.
Applicants provided a compliant species as follows
Compound of formula I:
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Species of cancer: non-small cell lung cancer
Examiner did not find prior art for applicant’s elected species. Therefore, Markush search was extended to the full scope of independent claim 37. No prior art was found. Therefore, election of species requirement is withdrawn.
Double patenting art was found for co-pending applications no. 18/191,574 (disclosed in the IDS).
Claims 37-47 are examined in this office action.
Current Status of 18/191,589
This Office Action is in response to the amended claims of 12/01/2025.
Claims 37-47 are new and are examined in this office action
Priority
Effective filing date is 10/12/2020.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 05/01/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 39 and 42 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.
Dependent Claims 39 and 42 recites limitation wherein R3 is “
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”. There is insufficient antecedent basis for R3 as “
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” in claim 37. Claim 37 does not recites R3 is “
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” an alternative for compound of formula II. As drafted, R3 is “
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” in claims 39 and 42 renders the metes and bounds of claims 39 and 42 undefined. Please note claim 42 have various structure where , R3 is “
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”, for example
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(page 4 of claims) ,
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(page 5 of claims) ,
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(page 6 if claims ) and
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(page 8 of claims). Hence renders claims 39 and 42 indefinite.
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.
Claims 39 and 42 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.
Dependent Claims 39 and 42 recites limitation R3 as “
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”, which fails to properly further limit independent claim 37, since claim 37 has no limitations drawn to R3 as “
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” for formula II. Please note claim 42 have various structure where , R3 is “
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”, for example
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(page 4 of claims) ,
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(page 5 of claims) ,
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(page 6 if claims ) and
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(page 8 of claims). Thus claims 39 and 42 rejected under 35 U.S.C. 112(d).
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 37 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being anticipated over claims 22 and 24 of co-pending Application No 18/191,574 (reference application, disclosed in the IDS). Instant claims of 12/01/2025 was used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 22 and 24 discloses compound
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and pharmaceutically acceptable salt, where A is a 5 membereed heteroaryl ,
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; R1 is H; R2 corresponds to
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wherein Y is O; L3 is NH, RE1= RE2= RE3 is H; R3 corresponds to
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wherein Y is O , L3 is a bond, z is 1 and RE4 is H same as formula II of instant claim 37.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 37,39 and 42 are rejected.
Claims 38, 40-41 and 43-47 are objected to for depending on a rejected claim.
Examiner did not find prior art on independent claim 37. Close art of Satijn et,al. (US-20230257479-A1) discloses the compound
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. Instant claim does not allow for R2 to be methyl or R3 as “
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”. An artisan skilled in the art could not envision the structural difference. Moreover, publication date of Satijn et.al. is after the prior date of current application. Thus, Satijn is a close art not a prior art.
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.
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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
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625