DETAILED ACTION
Claims 1-17, 21-22 and 24 are currently pending in the instant application.
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 .
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 10/29/2024 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
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.
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.
Claims 1-17, 21-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over FU (see US PG Pub No. US 2020/0361855, pub. 11/19/2020, filed 04/16/2020) as applied to claims 1-17, 21-22 and 24 above, and further in view of Chen (see J Clin Oncol 38: 2020 (suppl; abstr e17028).
FU teaches compounds of Formula
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with specific compounds such as
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taught (see compound 4, p. 22). Further FU teaches polymorphs of said compounds (see paragraph [0103], p. 7). The compounds are taught in a method for treating or lessening the severity of a disease, condition, or disorder where activation or over activation of HIF-2α is implicated in the disease state (see paragraph [0322], p. 32) with diseases such as various types of cancer taught (see paragraphs [0316]-[0319], p. 30-31). The compounds are taught to be administered in combination with anti-cancer agents, which include trastuzumab (see paragraphs [352]-[368], p. 34-37). FU does not disclose bladder cancer as the specific type of cancer that can be treated by the compounds.
Chen et al teach that knockdown of HIF2α reduces both inflammatory response and migratory activity in bladder cancer. Thus, HIF2α inhibitors would be helpful in the treatment of bladder cancer.
Thus, prior to the filing of the instant application, one of ordinary skill in the art would find it obvious to utilize the compounds of FU, which are taught to inhibit HIF2α and be useful in treating cancer to treat bladder cancer as Chen et al teach that knockdown of HIF2α reduces both inflammatory response and migratory activity in bladder cancer.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,267,782 (hereafter referred to as ‘782) in view of Chen (see J Clin Oncol 38: 2020 (suppl; abstr e17028). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘782 is drawn to compounds and pharmaceutical compositions of said compounds such as
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, which is disclosed in instant claim 10. “A claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,” extends to any and all such uses disclosed in the specification of the earlier patent. See In Re Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. In the instant case, Applicant is claiming methods of using compounds that overlap in scope with the compounds found in ‘782. However within ‘782, the compounds are disclosed to act as an inhibitor of HIF2α and be useful in treating cancer. Although ‘782 does not disclose bladder cancer as the specific type of cancer, Chen et al teach that knockdown of HIF2α reduces both inflammatory response and migratory activity in bladder cancer. Therefore, HIF2α inhibitors would be helpful in the treatment of bladder cancer. Thus, the methods of use embraced by the instant claims would be obvious given the teachings of ‘782 in view of Chen et al.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,753,366 (hereafter referred to as ‘366) in view of Chen (see J Clin Oncol 38: 2020 (suppl; abstr e17028). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘366 is drawn to compounds such as
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, which is among the compounds disclosed in instant claim 10. “A claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,” extends to any and all such uses disclosed in the specification of the earlier patent. See In Re Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. In the instant case, Applicant is claiming methods of using compounds that overlap in scope with the compounds found in ‘736. However within ‘366, the compounds are disclosed to act as an inhibitor of HIF2α and be useful in treating cancer. Although ‘366 does not disclose bladder cancer as the specific type of cancer, Chen et al teach that knockdown of HIF2α reduces both inflammatory response and migratory activity in bladder cancer. Therefore, HIF2α inhibitors would be helpful in the treatment of bladder cancer. Thus, the methods of use embraced by the instant claims would be obvious given the teachings of ‘366 in view of Chen et al.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,420,936 (hereafter referred to as ‘936) in view of Chen (see J Clin Oncol 38: 2020 (suppl; abstr e17028). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘936 is drawn to compounds such as
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, which is encompassed by instant claims 1-9. “A claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,” extends to any and all such uses disclosed in the specification of the earlier patent. See In Re Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. In the instant case, Applicant is claiming methods of using compounds that overlap in scope with the compounds found in ‘936. However within ‘936, the compounds are disclosed to act as an inhibitor of HIF2α and be useful in treating cancer. Although ‘936 does not disclose bladder cancer as the specific type of cancer, Chen et al teach that knockdown of HIF2α reduces both inflammatory response and migratory activity in bladder cancer. Therefore, HIF2α inhibitors would be helpful in the treatment of bladder cancer. Thus, the methods of use embraced by the instant claims would be obvious given the teachings of ‘936 in view of Chen et al.
Conclusion
None of the claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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