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 .
Election of Species and Status of the Claims
In response to the requirement for an election of species, Applicant hereby provisionally elects without traverse the of species identified as 3-Methyl-6'-{5-[(7S)-7-{3-oxa-6-azabicyclo[3.1.1 ]heptan-6-yl }-6, 7,8,9-tetrahydro-5H-benzo[7]annulen-2-yl ]-1H-pyrazolo[3,4-b]pyridin-3-yl }-2,3' -bi pyridine. (Example 26, pg. 118 of the Specification).
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as the single specific compound and the disease is pancreatic cancer in the response filed March 13th 2026 is acknowledged. Claims 1, 2, 5-12, 17-19, 21, 22, 25, 27, 30-34, 36-38, 45, and 46 are pending. Claims 39 and 40 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claim 39 is drawn to cancers that do not include pancreatic cancer and claim 40 recites the method of claim 34 for treating cancer and not pancreatic cancer which is relapsed or resistant to radiation therapy, chemotherapy, or immunotherapy. . Claims 1, 2, 5-12, 17-19, 21, 22, 25, 27, 30-34, 36-38, 45, and 46 are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. § 119(e) to U.S. Provisional Application serial No. 63/356,421, filed June 28, 2022.
Information Disclosure Statement
The Information Disclosure Statements filed on June 27th 2003 (21 references), May 28th 2024 (4 references) and March 13th 2026 (9 references) are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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, 2, 5-12, 17-19, 21, 22, 25, 27, 30-34, 36-38, 45, and 46 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 25-27, 31, 36 and 49 of copending Application No. 18988676 filed on December 19th 2024 (hereinafter‘676). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of these claims are found in either the claims or specification of the ‘676 Application. Both applications recite identical compounds; Compound (I) of ‘676 and the elected species of the instant application.
Compound (I) of ‘676 (claim 1) Elected species of Instant Appliction
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are identical in the ‘676 application and the instant application (as detailed in the election of species detailed above).
Claims 1, 2, 5-12, 17-19, 21, 22, 25, 27, 30-34, 36-38, 45, and 46 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 66-71, 73, 75-78 and 80-86 of copending Application No, 18555963 filed June 18th 2024 (hereinafter ‘963). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of these claims are found in either the claims or specification of the of the ‘963 Application. Both applications recite compounds in claim 1 with the same core structure (Formula 1b in ‘963) and (Formula I in the instant application) consisting of variables that obvious variants of each other. For example:
‘936 Claim 1 (Formula Ib)
Instant Application (Formula I)
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R1 each phenyl and 6-membered heteroaryl is substituted with 0-3 R3
R1 each phenyl and heteroaryl is substituted with one R1a and 0-3 R3
G3 is CRG3
G4 is CRG4
G5 is CRG5
X is CR5 or N;
G1 is N or CRG1
G2 is CRG2 or N
G3 is CRG03 or N'
G4 is CR04 or N
G5 is CR05 or N
RG2, is independently selected from H, halo, CN
RG2, is independently selected from consisting of H, halo, CN
n and m can both be 0
A is fused ring selected from the group consisting of cycloheptane
As can be seen by the comparison above the elements of both compounds are nearly identical and both are intended to treat pancreatic cancer (claim 83 of ‘963) and (claim 36 of the instant application).
Claims 1, 2, 5-12, 17-19, 21, 22, 25, 27, 30-34, 36-38, 45, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12,195,482 issued January 14th 2025 (hereinafter ‘482). Although the claims at issue are not identical, they are not patentably distinct from each other because both of the compounds are identical to the elected species of the instant application as detailed above. ‘482 details in claims 1 and 2 a compound (claim 2)and a pharmaceutically acceptable salt (claim 1). The instant claims include the use of the same compound to treat cancers including pancreatic cancer, but the elected compound species and the compound of‘482 are identical. See MPEP 2112.01:
II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
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Conclusion
Claims 1, 2, 5-12, 17-19, 21, 22, 25, 27, 30-34, 36-38, 45, and 46 are rejected; no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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, Jeffery Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.R.G./ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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