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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2021/050965, filed 09/17/2021, which claims the priority benefit of PRO Application No. 63/109,097, filed 11/03/2020 and PRO Application No. 63/079,720, filed 09/17/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/09/2023, 04/21/2023, and 01/21/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election without traverse of Group II, claims 7-11 and 13 with a species election of Navitoclax as the BCL-XL inhibiting compound for an anti-apoptotic protein inhibiting compound and colorectal cancer is elected as the cancer species in the reply filed 01/21/2026 is acknowledged.
Status of the Application
Claims 1-3, 5-11, 13, 15-18, 20, and 22-24 are pending. Claims 1-3, 5-6, 15-18, 20, and 22-24 have been withdrawn. Claims 4, 12, 14, 19, 21, and 25-28 have been cancelled by applicant without prejudice or disclaimer. Claims 7-11 and 13 are currently under examination herein insofar as they read on the elected invention and species.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, https://portals.broadinstitute.org/ccle/data (Specification, pg. 40). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 13 objected to because of the following informalities: administering in claim 13 line 2 should be changed to administration or alternatively “a route of the” should be deleted to promote clarity. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the compound name of venetoclax in claim 9, line 2 appears to be misspelled as “ventoclax”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 13 is 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. Claim 13 is dependent on claim 72 which does not exist in the current claim set. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim 13 complies with the statutory requirements.
This rejection may be overcome by amending the dependency of claim 13 to an independent claim under examination.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 7-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Gavathiotis (WO2018/222473Al).
Gavathiotis teaches Fig. 15A-15B wherein the B-cell lymphoma 2 associated X protein (BAX) activator compound GAV2-006 has significant synergistic cytotoxicity with (A) ABT-263 (navitoclax) and (B) ABT-199 (venetoclax) at non-cytotoxic doses for either compound in OCI-AML3 leukemia cells within 24h treatments [0025] Gavathiotis’s teachings anticipate the instant claims wherein BAX activating compound of GAV2-006 is administered with navitoclax or venetoclax in a treatment for cancer, GAV2-006 is equivalent to applicants structure of BTSA1.2, (MPEP 2131).
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Gavathiotis compound GAV2-006 (Left) Applicants compound BTSA1.2 (Right)
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 7-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gavathiotis (WO2018/222473Al).
The instant claims are directed to a method of treating a colorectal cancer in a subject comprising administering to the subject a B-cell lymphoma 2 associated X protein (BAX) activating compound of BTSA1.2 in combination with a B-cell lymphoma-extra-large protein (BCL-XL) inhibiting compound of navitoclax.
Gavathiotis et al. teach the B-cell lymphoma 2 associated X protein (BAX) compound of GAV2-006. Fig. 15A-15B wherein the BAX activator compound GAV2-006 has significant synergistic cytotoxicity with (A) ABT-263 (navitoclax) and (B) ABT-199 (venetoclax) at non-cytotoxic doses for either compound in OCI-AML3 leukemia cells within 24h treatments [0025]. Gavathiotis also discloses that the treatable cancer types can be colon cancer or colon carcinoma [0049]. Gavathiotis also teaches routes of administration include, but are not limited to, intravenous, intramuscular, intrathecal or subcutaneous injection, transdermal, oral or rectal administration, and injection into a specific site [0063]. Gavathiotis discloses that BAX activator compounds can have significant synergistic cytotoxicity with ABT-199 (venetoclax) or ABT-263 (navitoclax), as illustrated in Figs. 12-16. [00135]
However, Gavathiotis et al. fail to explicitly disclose applicants elected cancer of colorectal cancer as a condition treated by GAV2-006 and Navitoclax with such sufficient specificity to rise to the level of a 102(a)(1)/102(a)(2) rejection.
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to administer GAV2-006 and navitoclax in a method of treatment for colorectal cancer in a patient by following the disclosures of Gavathiotis who taught GAV2-006 and navitoclax or venetoclax displayed beneficial synergistic effects when administered in a combination cancer therapy.
A person of ordinary skill in the art would have been motivated to administer a combination colorectal cancer therapy with the compounds of GAV2-006 and navitoclax with a reasonable expectation of success following Gavathiotis’s disclosure that GAV2-006 and navitoclax displayed synergistic effects when administered together in a cancer therapy. A skilled artisan would have also found it obvious to try the combination cancer therapy on colorectal cancer when Gavathiotis discloses colon cancer and colon carcinoma as conditions treatable with the disclosed treatment method. See MPEP 2144.05(II)
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 7-11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9 and 11 of U.S. Patent No. US11382898. Although the claims at issue are not identical, they are not patentably distinct from each other because Gavathiotis (US PAT 11382898) anticipates instant claims 7-11 where the compounds of GAV-006 (applicants BTSA1.2) is administered in a combination therapy with ABT-199 (venetoclax) and ABT-263 (navitoclax) in a method of treating a solid tumor including breast cancer. With regard to claim 13, it would have been prima facie obvious to administer the composition via traditional methods of administration.
Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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 C 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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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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