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 .
In view of the Appeal Brief filed on 01/23/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
Response to Arguments
Applicants’ Appeal Brief filed 1/23/2026 are acknowledged and have been considered.
After further reconsideration, the 103 rejection is withdrawn. Applicants remarks with Examiner’s comment are summarized below:
Applicants submit that “for treating diffuse intrinsic pontine glioma” from base claim 20 was not considered and the intended use is legally incorrect.
The instant claims are composition claims; the phrase “for treating diffuse intrinsic pontine glioma” does not change the contents of the composition. This phrase was considered.
Applicants further submit the case law Sanofi and Entresto to support this.
Examiner has reviewed these cases.
Applicants submit further explanation about the unexpected results which are commensurate in scope with the instant claims. The data provided in the Table of the Declaration clearly showers that in every case, the predicted cell death of pHGG cells (such as DIPG cells) based on a simple additive effect of the drug combinations is close to only half of the observed cell death.
The Examiner has reconsidered the evidentiary record, including the declaration, and determines that the rejection is not maintained in view of the cited case law. In reviewing the obviousness rejection, Sulkowski, MOA, and Bubna all teach different cancers (compared to the instant DIPG).
The declaration declared that the results “demonstrated [that] a synergistic effect is obtained in preclinical studies involving the administration of ixabepilone and capecitabine, in combination, and that [the inventor] found this effect to be surprising”.
Applicants also submit that the data already provided would provide a reasonable basis for concluding that the untested embodiments encompassed by that claims would behave similarly to the tested embodiments.
In reconsidering and properly weighing the applicable precedent, the declaration’s evidence outweighs the asserted rationale for obviousness.
Applicants submit that Examiner has not provided any reason why, in view of the Declaration, a synergistic effect would also not be expected for other concentrations of these compounds. Therefore, Appellant respectfully requests reconsideration of the evidence of unexpected results presented in the Declaration.
In view of the case law and evidence of unexpected results, the declaration has been reconsidered and the present claims would not have been obvious. This point Applicants make is persuasive.
Response to Amendment
Election/Restrictions
Claims 20, 29-31, and 41-42 are allowable. The restriction requirement between inventions I and II, as set forth in the Office action mailed on 10/17/2022, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 10/17/2022 is withdrawn. Claims 1-18, which required all the limitations of an allowable claim, previously withdrawn from consideration as a result of the restriction requirement, were canceled by applicant in the reply filed on 01/02/2024. The canceled, nonelected claim(s) may be reinstated by applicant if submitted in a timely filed amendment in reply to this action. Upon entry of the amendment, such amended claim(s) will be examined for patentability under 37 CFR 1.104.
In view of the withdrawal of the restriction requirement as set forth above, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 20, 29-31, and 41-42 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/901,200 (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 claims 1-9 are drawn to a method of treating DIPG in a subject by administering (1) AG120 and (2) Olaparib, vorinostat, or a combination thereof. The instant claims are drawn to a composition of the same:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
A terminal disclaimer has already been filed for 18/065,073 (discussed in the Remarks of 02/27/2023).
No claims are allowed currently.
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.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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