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 .
Status of Claims
Claims 1-18 are pending in the instant application.
Priority
This application is a continuation of Application No. PCT/US2021/062101, filed 12/07/2021, which claims priority to Application Nos. 63/209,302, filed 06/10/2021, 63/161,153, filed 03/15/2021 and 63/124,495, filed 12/11/2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 03/30/2026 was considered by the Examiner.
Withdrawn Rejections
Applicant’s arguments, filed March 30th, 2026, with respect to nonstatutory double patenting rejection of claims 1-18 as being unpatentable over claims 1-3, 6-10 and 14-24 of copending Application No. 17/156,381 have been fully considered and are persuasive. The double patenting rejection of claims 1-18 has been withdrawn.
This rejection has been overcome as Application No. 17/156,381 has been abandoned.
Maintained Rejections
Applicant's arguments filed March 30th, 2026, with respect to the 35 U.S.C. 103 rejection of claims 1-18 over Wang in view of Green have been fully considered but they are not persuasive.
See response to remarks.
Response to Remarks
Applicant traverses the 103 rejection over Wang in view of Green on the premise that Wang does not disclose inavolisib or any combination comprising inavolisib. Applicant further argues that Greene does not teach or make obvious that inavolisib can be combined with trastuzumab and pertuzumab.
In response, as stated in the previous Office action, as Wang teaches a method of treating HER2-positive breast cancer with a combination of paclitaxel, trastuzumab, and pertuzumab and the considerations of the addition of an additional chemotherapy partner one of ordinary skill in the art would have been motivated to include inavolisib in the method taught by Wang and would have a reasonable expectation of success as Green teaches that inavolisib treats metastatic PIK3CA breast cancer. Thus, paclitaxel, trastuzumab, pertuzumab and inavolisib are known in the art to treat breast cancer.
See MPEP 2144.06: 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) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Applicant has not provided data consummate in scope with the instant claims that showcase unexpected properties of the instant invention to rebut the case of prima face obviousness. As such, the 103 rejection is maintained.
Applicant’s arguments with respect to double patenting rejection of claims 1-18 have been considered but are moot because the rejection has been overcome as the copneding application has been abandoned.
Maintained 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.
Claim(s) 1-18 stand rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (The Oncologist 2019;24:e646–e652) in view of Greene et al (WO 2020/023297 A1).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Wang teaches a method of treating HER2-poisitive metastatic breast cancer with a combination of paclitaxel, trastuzumab, and pertuzumab (abstract). Wang teaches that adult patients with HER2-positive metastatic breast cancer received paclitaxel (80 mg/m2 weekly) with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks), administered in 21-day cycles (abstract).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach that inavolisib is also included in the combination therapy for the treatment of HER2-positive breast cancer.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Wang teaches that a randomized study should be considered to further evaluate trastuzumab/pertuzumab-based treatment (with a different chemotherapy partner) after progression beyond this combination of dual antibody therapy (page e651, right column, paragraph 1).
Further, Greene teaches a method for the treatment of metastatic PIK3CA-mutant solid tumors and breast cancer comprising administering a therapeutically effective amount of GDC-0077 (claims 1, 5 and 6). GDC-0077 is inavolisib, as defined in paragraph [0021] of the instant specification.
Regarding claim 1, as Wang teaches a method of treating HER2-positive breast cancer with a combination of paclitaxel, trastuzumab, and pertuzumab and the considerations of the addition of an additional chemotherapy partner one of ordinary skill in the art would have been motivated to include inavolisib in the method taught by Wang and would have a reasonable expectation of success as Green teaches that inavolisib treats metastatic PIK3CA breast cancer. Regarding claim 16,Greene teaches that treatment includes the inhibition of tumor growth in breast cancer harboring PIK3CA mutation (page 9, paragraph 1). Regarding claim 17, Greene teaches that the PI3K pathway is an attractive target for cancer drugs since such agents would be expected to repress signals from stromal cells that provide for survival and chemoresistance of cancer cells (page 2, paragraph 3). Green further teaches that inavolisib is a PI3K inhibitor (abstract).
See MPEP 2144.06: "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) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Regarding claim 2, Wang teaches that trastuzumab and pertuzumab are administered every three weeks (Figure 1) and Green teaches that inavolisib is administered QD on day 1 of the cycle (Example 2, page 27). Regarding claim 4, Wan teaches that the study was repeated for six months (page e647, right column, paragraph 4). Regarding claim 18, Greene teaches that inavolisib is administered at an amount of 9 mg (claim 5).
Regarding claim 3, Wang teaches that paclitaxel is administered every week and trastuzumab and pertuzumab are administered once every three weeks after a loading dose. Wang further teaches that this cycle was repeated for six months (page e647, right column, paragraph 4). Further, Green teaches that inavolisib is administered QD on day 1 of the cycle (Example 2, page 27).
Regarding claim 5, Greene teaches that inavolisib is administered at an amount of 9 mg (claim 5).
Regarding claim 6, Green teaches that inavolisib is provided as a tablet in amount of 9 mg to be administered daily by mouth (page 26, Example 1).
Regarding claim 7, Wang teaches that trastuzumab is administered as an 8 mg/kg loading dose followed by 6 mg/kg every 3 weeks intravenously (abstract, paragraph 2).
Regarding claim 8, Wang teaches pertuzumab is administered as an 840 mg loading dose followed by 420 mg every 3 weeks intravenously cycle (abstract, paragraph 2).
Regarding claim 9, Wang teaches that paclitaxel is administered as an 80 mg/m2 dose, weekly (abstract, paragraph 2). Wang further teaches that this cycle was repeated for six months (page e647, right column, paragraph 4).
Regarding claim 10, Wang teaches that the patients of the study had a baseline LVEF of ≥50% (page e647, left column, paragraph 3).
Regarding claim 11, Green teaches that the breast cancer can be HR+ (page 11, paragraph 2).
Regarding claim 12, Greene teaches that fulvestrant is administered in combination with inavolisib to treat breast cancer (page 18 and claim 14).
Regarding claim 13, Greene teaches that fulvestrant is to be administered once monthly at a dose of 500 mg by intramuscularly (page 25, paragraph 1).
Regarding claim 14, Greene teaches that letrozole is administered in combination with inavolisib (claims 13-14).
Regarding claim 15, Greene teaches that letrozole is available as 2.5 mg tables (page 26, paragraph 7).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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