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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/08/2025 has been entered.
Response to Arguments
Applicants’ claim amendments and Remarks of 9/9/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
The 102 rejection is withdrawn due to applicant’s amendments and remarks that DMSO is not a pharmaceutically acceptable excipient.
The obviousness rejection is withdrawn. Applicants Remarks with Examiners Reply is summarized below:
Applicants submit that URAS does not motivate the artisan because it relates to a different disease space (AML vs. solid tumors).
Examiner has reviewed URAS again and agrees with applicant that URA does not specify that palbociclib and sunitinib has synergy.
Applicants also point out reasons for why it would not be obvious to assume successful effect of combination treatment of solid tumors with palbociclib and sunitinib based on treatment of AML cell lines on pages 12-13.
Examiner has reviewed these pages and finds them persuasive.
Applicants additionally point out how Korashy does not make the claimed combination obvious.
Response to Amendment
Claim Rejections - 35 USC § 102
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.
Claim(s) 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Clinical Trials (“Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia”, Clinical Trials ID: NCT03132454 Version 10, 08/15/2018) as evidenced by FDA ( “IBRANCE® (palbociclib) tablets, for oral use”, FDA, Reference ID: 4514390, initial approval 2015, Revised 2019).
Clinical Trials anticipates that in Cycle 2, a patient receives palbociclib (CDK4/6 inhibitor; administering IBRANCE) and sorafenib (mtRTKI) (Detailed description).
FDA is relied upon for the beneficial teaching that IBRANCE (the brand name for a medication containing palbociclib) contains the inactive ingredients including microcrystalline cellulose (page 14). These inactive ingredients are pharmaceutically acceptable excipients.
This anticipates claim 21.
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, 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.
Claim(s) 1, 2, 4, 7, 9, 21-23 and 43, 44, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over PEREZ (Perez et al., “Efficacy of CDK4 inhibition against sarcomas depends on their levels of CDK4 and p16ink4 mRNA”, Oncotarget, October 20, 2015), as evidenced by FDA ( “IBRANCE® (palbociclib) tablets, for oral use”, FDA, Reference ID: 4514390, initial approval 2015, Revised 2019) and in view of MAHMOOD (Mahmood et al., “Phase II Study of Sunitinib Malate, a Multi-Targeted Tyrosine Kinase Inhibitor in Patients with Relapsed or Refractory Soft Tissue Sarcomas. Focus on 3 Prevalent Histologies: Leiomyosarcoma, Liposarcoma, and Malignant Fibrous Histiocytoma”, Int J Cancer, October 15, 2011).
PEREZ teaches that palbociclib (PD0332991), a highly selective inhibitor of CDK4/6, being used to treat sarcoma in vivo (abstract). This helps teach claim 1, 2, 4, 43, and 44 (i).
PEREZ teaches palbociclib is useful in treating Liposarcoma cell line (table 1). This helps teach claims 7 and 45.
PEREZ teaches the drug (Palbociclib, PD0332991), was obtained from Pfizer, freshly prepared and orally administered (In vivo treatments). PEREZ teaches the concentration used in human is 125mg/dose (In vivo treatments). This helps teach limitation (i) from claim 9 and 23.
FDA is relied upon for the beneficial teaching that the oral dosage of palbociclib contains the inactive ingredients including microcrystalline cellulose (page 14). These inactive ingredients are pharmaceutically acceptable excipients. This helps teach claim 21.
While PEREZ teaches Palbociclib, PEREZ does not teach Sunitinib.
MAHMOOD teaches that Sunitinib is useful for treating liposarcoma (table 3). This helps teach claim 1, 2, 4, 43, and 44 (i). This helps teach claims 7 and 45.
MAHMOOD teaches Patients received 50 mg of sunitinib malate orally once daily on days 1-28 of a planned 42-day cycle (study design). This helps teach limitation (i) from claim 9 and 23.
The artisan would have found it obvious to combine Palbociclib and sunitinib, which are known to have anti-liposarcoma properties (PEREZ abstract; MAHMOOD abstract). It is prima facie obvious to combine one anti- liposarcoma compound with another in order to form a composition to be used for the very same purpose (treating liposarcoma). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches 1, 2, 4, 7, 9, 43, 44, and 45.
The artisan would have also found it obvious to administer a pharmaceutical composition containing a pharmaceutically acceptable excipient. Combining Palbociclib with sunitinib, the artisan would have at least kept the excipient (microcrystalline cellulose) from Pfizer’s palbociclib (FDA page 14). This teaches claims 21-23.
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.
Claim 1, 2, 9, 21-23, and 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/975,802 (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.
Reference claim 1 (treating ACC, which is a solid cancer, with palbociclib and sunitinib) anticipates instant claim 1 (treating solid cancer with palbociclib and sunitinib) and claim 4, and claim 43-45.
Ref. claim 2-5 anticipates instant claim 2.
Ref. claim 6 and 7 anticipates instant claim 9 (i) and 23.
Ref. claim 1 anticipates instant claim 21 and 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed as 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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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.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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