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 .
Acknowledgement of Receipt
Applicant's response filed on 09/16/2025 to the Office Action mailed on 06/16/2025 is acknowledged.
Claim Status
Claims 6-15, 18 and 19 are pending.
Claims 6, 8-11, 18 and 19 are currently amended.
Claim 1-5, 16, 16, and 20 are cancelled.
Claims 6-15, 18 and 19 have been examined.
Claims 6-15, 18 and 19 are rejected.
Priority
Priority to 371 application PCT/US21/34255 filed on 05/26/2021, which claims priority to provisional application 63/030338 filed on 05/27/2020 is acknowledged.
Drawings
The drawings filed on 11/23/2022 are accepted.
Withdrawn Claim Rejections - 35 USC § 102
Response to Applicant’s Arguments
The rejection of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Balakrishnan et al. (The phosphoinositide-3-kinase (PI3K)-delta and gamma inhibitor, IPI-145 (Duvelisib), overcomes signals from the PI3K/AKT/S6 pathway and promotes apoptosis in CLL, Published 05/19/2015) is moot since the claim is cancelled.
The rejection of claims 1, 2, and 4 under 35 U.S.C. 102(a)(1) as being anticipated by Niu et al. (US Patent Application Publication 2011/0230476 A1, Published 09/22/2011) is since the claims are cancelled.
The rejection of claims 6 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Niu et al. (US Patent Application Publication 2011/0230476 A1, Published 09/22/2011) is withdrawn in view of the amendments to the claims.
Withdrawn, Maintained and New Claim Rejections - 35 USC § 103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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Response to Applicant’s Arguments
The rejection of claims 1, 2, 4, 5, 16 and 20 under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (Taiwanese Patent Application Publication 201622726 A, Published 07/01/2016) is moot since the claims are cancelled.
The rejection of claims 6-8, 11-13, and 15 under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (Taiwanese Patent Application Publication 201622726 A, Published 07/01/2016) is withdrawn in view of the amendments to the claims.
The rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (Taiwanese Patent Application Publication 201622726 A, Published 07/01/2016) as applied to claims 1, 2, 4-8, 11-13, 15, 16, and 20 above, and further in view of Jin et al. (AS252424, a PI3Kγ Inhibitor, Downregulates Inflammatory Responsiveness in Mouse Bone Marrow-Derived Mast Cells, Published 03/01/2014) is withdrawn in view of the amendments to the claims.
The rejection of claim(s) 1-3, and 5 under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (International Application Published Under the PCT WO 2015193740 A2, Published 12/23/2015) is moot since the claims are cancelled.
The rejection of claims 6 and 11-14 under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (International Application Published Under the PCT WO 2015193740 A2, Published 12/23/2015) is withdrawn in view of the amendments to the claims.
Claim(s) 1, 2, 4-8, 11-13, 15, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (Taiwanese Patent Application Publication 201622726 A, Published 07/01/2016).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to treat acute myeloid leukemia with the combination of PI3K- γ inhibitor and a BTK inhibitor and have a reasonable expectation of success. One would have been motivated to do so since Hamdy et al. teach the AML is among the diseases that can be treated with the combination of inhibitors. For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
This rejection is modified and reiterated from the previous Office Action in view of the amendments to the claims.
Claim(s) 6, 7, 10-13, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (Taiwanese Patent Application Publication 201622726 A, Published 07/01/2016) in view of Taube (US Patent Application Publication 2014/0154304 A1, Published 06/05/2014).
Hamdy et al. teach therapeutic combination of a phosphoinositide 3-kinase (PI3K) inhibitor, including PI3K inhibitors selective for the γ - and δ -isoforms and selective for both γ- and δ -isoforms, and a Bruton's tyrosine kinase (BTK) inhibitor (abstract). Another embodiment of the invention is a method of treating a disease or condition in an individual, particularly a hyperproliferative disorder of an individual, such as leukemia, lymphoma or solid tumor cancer, the method comprising co-administering treatment to an individual in need of such treatment (paragraph 0165). In an exemplary embodiment, the leukemia is selected from the group consisting of acute myeloid leukemia (AML), chronic myeloid white Blood disease (CML) and acute lymphoblastic leukemia (ALL) (paragraph 0167).
Hamdy et al. lacks a preferred embodiment wherein the combination of chemotherapeutic agents is administered to treat a myeloid malignancy. However, Hamdy et al. makes such a treatment obvious.
Hamdy et al. lacks a teaching wherein the method comprises administering a compound such as daunorubicin.
Taube teach treating acute myeloid leukemia with a combination of volasertib, fludarabine, cytarabine, GCSF, and daunorubicin citrate (abstract).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention combine the methods of Hamdy et al. and Taube and have a reasonable expectation of success. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960). Hamdy et al. and Taube are both directed to treating acute myeloid leukemia. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Response to Applicant’s Arguments
Applicant argues there is no suggestion to substitute the BTK inhibitors of Hamdy et al. should be substituted with the therapeutic agents of Taube. Applicant’s argument has been fully considered but found not to be persuasive. The rejection on record does not suggest a substitution of BTK inhibitors but the addition of third compound taught by Taube. The motivation to add this compound is that the compounds of Taube are taught to treat the same conditions as those of Hamdy et al.
Applicant argues that the inventor found that the application of PI3K-gamma inhibitors renders AML cells more sensitive to specific chemotherapeutic agents and that one of ordinary skill in the art could not have predicted such an effect from the teachings of Hamdy et al. and Taube. Applicant’s argument has been fully considered but found not to be persuasive. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). For the foregoing reasons the rejection is maintained.
This is a new ground of rejection necessitate by the amendment to the claims.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (Taiwanese Patent Application Publication 201622726 A, Published 07/01/2016) in view of Taube (US Patent Application Publication 2014/0154304 A1, Published 06/05/2014), as applied to claims 6, 7, 10-13, 15, and 18 above, and further in view of Jin et al. (AS252424, a PI3Kγ Inhibitor, Downregulates Inflammatory Responsiveness in Mouse Bone Marrow-Derived Mast Cells, Published 03/01/2014).
The teachings of Hamdy et al. and Taube are discussed above.
Hamdy et al. does not teach that the PI3Kγ inhibitor is AS252424.
Jin et al. teach AS252424 is a PI3Kγ inhibitor (title).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to use AS252424 in the method of Hamdy et al. and have a reasonable expectation of success. One would have been motivated to do so since Hamdy et al. teach that PI3Kγ inhibitor are useful in treatment of AML and Jin et al. teach AS252424 is a PI3Kγ inhibitor. For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
This is a new ground of rejection necessitate by the amendment to the claims.
Claim(s) 8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamdy et al. (Taiwanese Patent Application Publication 201622726 A, Published 07/01/2016) in view of Taube (US Patent Application Publication 2014/0154304 A1, Published 06/05/2014), as applied to claims 6, 7, 10-13, 15, and 18 above.
The teachings of Hamdy et al. and Taube are discussed above.
Hamdy et al. lacks a preferred embodiment wherein a composition comprising a PI3K-γ inhibitor is used to treat myeloproliferative neoplasm. However, Hamdy et al. makes such a method obvious.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to administer a PI3K-γ inhibitor for the treatment of myeloproliferative neoplasm and have a reasonable expectation of success. One would have been motivated to do so since Hamdy et al. teach that such methods are within the scope of the methods of Hamdy et al. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614