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 .
Current Status of 18/901,200
This Office Action is responsive to the original claims of 09/30/2024.
Claims 1-9 are examined on the merits.
Priority
This application is a divisional of Application 17/303,457, which claims priority from US provisional application 63/032,653. Application 17/303,457 also has a continuation in part (application 18/065,073). There is also a PCT application in the family.
The instant claims find support from the provisional application. Therefore, the effective filing date is 05/31/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/30/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20, 29-31, 41-42 of copending Application No. 17/303,457 (reference application). Although the claims at issue are not identical since the instant application (“instant”) is drawn to a method of use of the compound of the reference patent (“reference”), they are not patentably distinct from each other because both instant and reference are drawn to the same underlying compound. Sun Pharmaceutical Industries, Ltd. vs. Eli Lilly and Company, 611 F.3d 1381 (Fed. Cir. 2010).
Ref claim 20 teaches the instant composition and teaches that composition is intended to treat DIPG (the instant disease which is treated).
Ref claim 29 teaches instant claim 5.
Ref claim 30 teaches instant claim 6.
Ref claim 31 teaches instant claim 7.
Ref claim 41 teaches instant claim 8.
Ref claim 42 teaches instant claim 9.
Ref specification teaches administering to a subject (page 2). This teaches instant claim 2.
Ref specification teaches on page 2 the method further includes administering ionizing radiation. This teaches instant claim 3.
The ref claims do not anticipate administering the composition or administering to a subject.
The artisan would have found it obvious and would have been expected to administer the reference composition in order to treat DIPG.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 8 are provisionally rejected on the ground of nonstatutory anticipatory-type double patenting as being unpatentable over claims 1, 3, 7-8, 10-24 of copending Application No. 18/065,073 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Ref claim 1 anticipate a method for treating cancer in a subject by administering two or more compounds and by administering radiation before, during or after administration. This anticipates instant claims 1-3 and 8.
Ref claim 10 anticipate DIPG which anticipates the disease of instant claim 1.
Ref claims 12 and 13 anticipate the instant compounds of claim 1.
Close Art
Salkowski in view of Mao, Zhao, and Bubna were considered to be close art in application 17/303,457 (which is drawn to the instant composition and the methods). This obviousness rejection (which had arrived at the instant composition) was withdrawn in the Nonfinal rejection of 6/2/2026.
Applicants submitted a declaration in 17/303,457 on 9/19/2024. These points will be reiterated below as they relate to this application.
Diffuse Intrinsic Pontine Glioma (DIPG) is the most common fatal central nervous system tumor of children (point 5). It was well recognized that DIPGs were fatal with no known successful treatments (point 6).
Applicants submit VANAN to show that DIPG is biologically distinct from other high-grade gliomas and chemotherapy for other pediatric and adult high-grade gliomas should not be applied to DIPG (as they have not been successful) (point 7).
Several inhibitors tested to treat H3 mutant pediatric high-grade gliomas such as DIPG have not been effective (point 9). Vorinostat monotherapy failed to improve outcomes in children with newly diagnosed DIPG (SU and point 9). Olaparib was well tolerated in patients with recurrent or progressive contrast-enhancing IDH1/2mt glioma but did not meet prespecified response-based activity criteria for moving to stage 2 of trial (point 11).
Because this application is directed to a method of treating DIPG, this is found persuasive.
There is another Declaration filed 3/29/2024. Akash Gunjan submit Table 1, which shows different compounds effects on H3.3K27M mutant pediatric high grade glioma cells. The results of this table is shown in survival percentages of the cells.
Conclusion
No claims are allowed as currently written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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