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 . Claims 1-11, 15-20 filed October 06, 2025 are currently pending. Claim 1 is independent.
Election/Restrictions
Applicant’s election without traverse of Group (I) in the reply filed on 10/06/2025 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/06/2025.
Secondly, Applicant’s election of
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in the reply filed 10/06/2025 is acknowledged. The elected species reads on the following structural limitations: Ring F is phenyl substituted by R1’, wherein R1’ is halogen, Ring B is phenyl substituted with R2 wherein R2 is hydrogen. Claims 4-5 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/06/2025.
Species Election
After a comprehensive search, the examiner has indicated that the elected species is free of the prior art. A claim directed to the elected species would be allowable over the prior art. The examiner has moved on to alternative species embraced within the claimed genus:
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., including wherein Ring F is phenyl substituted by R1’, wherein R1’ is heteroaryl, Ring B is phenyl, substituted by R2, wherein R2 is H, and subsequent examination is based on this species expansion.
Priority
Acknowledgement is made of the continuation of PCT/US2021/155104 filed 10/14/2021 which claims priority to U.S. Provisional Application 63091894 filed 10/14/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/21/2023 and 10/08/2025 are 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 § 103
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.
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, 6-7, 10-11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Veits (WO2021/127586 published 06/24/2021 with priority to U.S. Provisional Application 62952097 filed 12/20/2019).
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Veits (WO2021/127586 published 06/24/2021 with priority to U.S. Provisional Application 62952097 filed 12/20/2019) teaches compound 1 as shown above, which reads on the structural limitations of the present claims: Ring B is phenyl substituted with R2 wherein R2 is H and alkyl substituted with R1, Ring F is phenyl (page 467). Regarding claim 7, 10 and 11 X2 is a bond, R15 is a bond, R16 is alkyl, R17 is NR27 wherein R27 is H and R28 is alkyl.
Accordingly, the only difference between the instantly claimed species and that claimed in Veits is the positional isomerism of the R1’ on the tricyclic core, as the compound of Veits comprises R1’ of alkyl substituted with R1 on Ring B instead of Ring F. Yet, as stated by MPEP 2144.09, "[A] prima facie case of obvious may be made when chemical compounds have very close structural similarities and similar utilities. An obvious rejection 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." Moreover, "[C]ompounds which are positional isomers, (compounds having the same radicals in physically different positions on the same nucleus, such as compound 1 of Veits and the formulas in the instant application) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties." Please see In re Payne 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979) and In re Wilder 563 F.2d 457 195 USPQ 426 (CCPA 1977). As shown in the structure below compound 1 of Veits, Veits further discloses that substituents are permitted on any point of the aryl ring of the modified lenalidomide substructure which corresponds to cycle F of the present claims (page 19).
Further, as stated in In re Norris 179 F.2d 970, 84 USPQ 458 (CCPA 1970) a novel, useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In other words, if the positional isomers of the instant application produced unexpected results that would not be obvious to one of ordinary skill in the art, they would be patentably distinct, however, there is no such evidence of such results in the instant application. Thus, at the time of invention was made, one of ordinary skill in the art would have been motivated to modify the alkyl substituted with R1 moiety of R2 on Ring B of Veits to the R1’ position on Ring F to give the claimed tricyclic derivative with a reasonable expectation of success.
Claim(s) 1-3 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson (WO2020/210630 published 10/14/2020 with priority to U.S. Provisional Application 62833107 filed 04/12/2019).
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Henderson (WO2020/210630 published 10/14/2020 with priority to U.S. Provisional Application 62833107 filed 04/12/2019) teaches compound 10 as shown above, which reads on the structural limitations of the present claims: Ring B is phenyl substituted with R2 wherein R2 is H and NH2 (page 248).
Accordingly, the only difference between the instantly claimed species and that claimed in Henderson is the positional isomerism of the R1’ on the tricyclic core, as the compound of Henderson comprises R1’ of amine on Ring B instead of Ring F as shown in the structure above.
Yet, as stated by MPEP 2144.09, "[A] prima facie case of obvious may be made when chemical compounds have very close structural similarities and similar utilities. An obvious rejection 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." Moreover, "[C]ompounds which are positional isomers, (compounds having the same radicals in physically different positions on the same nucleus, such as compound 10 of Henderson and that of the compound claimed in the instant application) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties." Please see In re Payne 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979) and In re Wilder 563 F.2d 457 195 USPQ 426 (CCPA 1977).
Further, as stated in In re Norris 179 F.2d 970, 84 USPQ 458 (CCPA 1970) a novel, useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In other words, if the positional isomers of the instant application produced unexpected results that would not be obvious to one of ordinary skill in the art, they would be patentably distinct, however, there is no such evidence of such results in the instant application. Thus, at the time of invention was made, one of ordinary skill in the art would have been motivated to modify the amine moiety on Ring B of compound 10 of Henderson to the R1’ position on Ring F to give the claimed tricyclic derivative with a reasonable expectation of success.
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.
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Claims 1-3, 6-7, 10-11 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,407,732.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Henderson teaches compounds of the formula above that read on the present claims: Ring B is phenyl substituted with R2 wherein R2H and is also X3, R15, R16 R17 and R18 wherein X3 is a bond, R15 is aryl, R16 is a bond and R17 is a heterocycle and R18 is H appending the heterocycle, Ring F is phenyl. Accordingly, the only difference between the instantly claimed species and that claimed in Henderson is the positional isomerism of the R1’ on the tricyclic core, as the compound of Henderson comprises R1’ of amine on Ring B instead of Ring F as shown in the structure above.
Yet, as stated by MPEP 2144.09, "[A] prima facie case of obvious may be made when chemical compounds have very close structural similarities and similar utilities. An obvious rejection 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." Moreover, "[C]ompounds which are positional isomers, (compounds having the same radicals in physically different positions on the same nucleus, such as compound 10 of Henderson and that of the compound claimed in the instant application) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties." Please see In re Payne 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979) and In re Wilder 563 F.2d 457 195 USPQ 426 (CCPA 1977).
Further, as stated in In re Norris 179 F.2d 970, 84 USPQ 458 (CCPA 1970) a novel, useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In other words, if the positional isomers of the instant application produced unexpected results that would not be obvious to one of ordinary skill in the art, they would be patentably distinct, however, there is no such evidence of such results in the instant application. Thus, at the time of invention was made, one of ordinary skill in the art would have been motivated to modify the moiety of X3-R15-R16-R17-R18 tether appending cycle B wherein X3 is a bond, R15 is aryl, R16 is a bond and R17 is a heterocycle and R18 is H amine moiety on Ring B of Henderson to the R1’ position on Ring F to give the claimed tricyclic derivative with a reasonable expectation of success.
Claims 1-3, 6-8, 10-11 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18134985 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claims 1-15 of copending Application 18134985 claims compounds of Formula (I), which includes
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., Said compound reads on the present claims as follows: Ring F is phenyl substituted by R1’, wherein R1’ is heteroaryl, Ring B is phenyl, substituted by R2, wherein R2 is H.
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Regarding pending claim 7, the following compound in claim 15 of copending Application 18134985 reads on the presently claimed structural limitations: R1’ is X3-R15-R16-R17-R28, wherein X3 is heterocycle, R15 is a bond, R16 is an aryl, R17 is -SO2- and R28 is heterocycle.
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Regarding pending claim 8, the following compound in claim 15 of copending Application 18134985 reads on the presently claimed structural limitations: R1’ is X2-R24-R23-R22-R21-R28, wherein X3 is heterocycle, R24 is a bond, R23 is an aryl, R22 is -SO2- , R21 is heterocycle and R28 a hydrogen appending the R21 morpholine heterocycle.
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Regarding claims 10-11, the structure shown above reads on the claimed limitations wherein X3 is -NR27, wherein R27 is alkyl, R15 is a bond, R16 is a bond R17 is -O- and R28 is hydrogen. Lastly, the subject matter of pending claim 15 in copending Application 18134985 reads on the subject matter of present claim 16.
Conclusion
Claims 1-3, 6-8, 10-11 and 15-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W KOSTURKO/Examiner, Art Unit 1621