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 .
Application Status
The amendment filed on 6/02/2026 in response to the Non-Final Rejection of 3/04/2026 is acknowledged and has been entered. Claims 15-33 are currently pending and under consideration.
Response to Amendment
The declaration under 37 CFR 1.132 filed on 6/02/2026 is insufficient to overcome the rejection of claims 1-2, 11-22, and 25-27 based upon the rejection under 35 U.S.C. 103 as set forth in the last Office action because: the declaration, by Wei Wei, only appears to provide the original tumor volume data of each mouse in each group of the experiments of Examples 1, 5, 7 and 8. While Applicants representative has used this data to draw conclusions on potential synergy of the combination compared to each monotherapy alone, the declarant makes no statement of conclusion.
Rejections Maintained, but amended in view of Applicants amendments:
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) 15-22 and 25-27 remain rejection and new claims 28-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kutok, Jeffery (US2019/0216816A1, 2019-07-18, IDS) referred to herein as Kutok in view of Medshine Discovery Inc. (CN105461712A, 2016-04-06, IDS translation provided) referred to herein as Medshine and Trantelli et al. (International Journal of Molecular Sciences 2020; 21: 1060).
Kutok teaches pharmaceutical compositions and methods of treatment comprising administration of the compositions, wherein the composition comprises a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator (Abstract). With regards to the immune checkpoint modulator, Kutok teaches that the immune checkpoint modulator is an inhibitor of PD-1, wherein the inhibitor of PD-1 is an anti-PD-1 inhibitor such as Nivolumab, Pembrolizumab (a humanized antibody), Durvalumab (claims 8-14 of the Kutok). With regards to the cancer, Kutok teaches that cancer includes, but is not limited to, solid tumors such as colon and cancers of hematopoietic origin such as lymphoma and leukemia (paragraph 0130). For example, Kutok teaches a phase 1b clinical trial for treatment of patients with hematological malignancies (follicular lymphoma, DLBCL and T-cell lymphoma) comprising administering a combination of compound 1 (a PI3K inhibitor) and an anti-PD-1 antibody (Nivolumab and Pembrolizumab) (Example 2). In addition to the pharmaceutical compositions comprising a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator, Kutok teaches kits, wherein the kits comprise the pharmaceutical compositions comprising a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator or alternatively, the kits are provided as separate pharmaceutical compositions in separate containers within the kit (paragraphs 0623-0625).
Kutok does not specifically teach that the PI3K inhibitor is a compound of formula I:
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, specifically
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Medshine teaches that the PI3K pathway is the most frequently mutated site in the human cancer cells, wherein PI3K and mTOR are the two most important kinases in the PI3K signaling pathway (Background). Accordingly, Medshine teaches a class of pyrido[1,2-a]pyrimidone analogs as mTOR/PI3K inhibitors for treatment of cancer having the generic structure
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(abstract). In particular, Medshine teaches a number of specific compound which read on the instant claims including, but not limited to,
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referred to as compound 176 and has less than 1 nM inhibitor activity for both p-AKT and p-p70S6K (page 88 and page 128).
Trantelli et al. teaches that it is recognized that there are different classes of compounds targeting the PI3K/AKT/mTOR pathway including pan-PI3K inhibitors, isoform specific inhibitors (i.e. idelalisib), dual PI3K/mTOR inhibitors, AKT inhibitors, allosteric mTOR inhibitors (rapalogs) inhibitors and mTOR kinase inhibitors, wherein an interesting strategy is to target several PI3K isoforms as well as mTOR instead of a single PI3K isoform or only mTOR (page 5 of 22, section 6). In particular, Trantelli et al. teach that the catalytic isoform of the p110 subunit and mTOR have structural similarities, and targeting two crucial points of the same pathway could lead to higher efficacy, could overcome feedback inhibition coming from mTOR inhibition, and the risk of drug resistance that should easily come out in the case of treatment with compounds targeting a single p110 isoform, wherein dual PI3K/mTOR inhibitors have shown, at least in the preclinical setting, an improved than what achieved targeting individually single PI3K isoforms, all PI3K isoforms or mTOR (page 5 of 22, section 6).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition as taught by Kutok by substituting the PI3K inhibitor for the compounds taught by Medshine in view of the teachings of Trantelli et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Trantelli et al. teaches that targeting two crucial points of the same pathway could lead to higher efficacy, could overcome feedback inhibition coming from mTOR inhibition, and the risk of drug resistance that should easily come out in the case of treatment with compounds targeting a single p110 isoform, wherein dual PI3K/mTOR inhibitors have shown, at least in the preclinical setting, an improved than what achieved targeting individually single PI3K isoforms, all PI3K isoforms or mTOR
Moreover, "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)
In response to this rejection, Applicants contend that one of ordinary skill in the art would not believe that replacing PI3K inhibitor in Kutok comprised in the composition with PI3K/mTOR inhibitors in Medshine would achieve a composition with similar effects, on the basis of the three rejections. In particular, Applicants contend that Trantelli is directed towards monotherapy, and does not necessarily mean that replacing a single PI3K inhibitor comprised in a composition containing other drug with Dual PI3K/mTOR inhibitor would result in a composition with similar effects, wherein multiple-target drugs have more complicated drug-drug interactions compared to single target drugs and it remains unclear whether targeting mTOR would bring unfavorable impacts on the composition comprising a PI3K inhibitor in combination with PD-1 inhibitor in Kutok. Regarding Kutok and Meshine, Applicants contend that Kutok focus is on the combined use of a PI3K
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dual inhibitor, whereas the dual PI3K/mTOR inhibitors disclosed by Medshine specifically exhibits inhibitory activity against PI3Ka and does not disclose that the dual PI3K/mTOR inhibitors have inhibitory activity on PI3K
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. Accordingly, Applicants contend that it is known in the art that various subunits of PI3K do not function the same, wherein PI3K-a and PI3K-b are widely expressed and are important mediators of signaling from cell surface receptors, whereas PI3K-g and d are preferentially expressed in leukocytes and are important in leukocyte function. With the functional differences in mind, Applicants contend that one of ordinary skill in the art tend to think dual PI3K/mTOR inhibitors in Medshine function differently from PI3K inhibitors in Kutak and thereof, there is no reasonable expectation of success.
These arguments have been carefully considered, but are not found persuasive.
First, the Examiner recognizes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, as noted above and incorporated herein, Trantelli et al. provides motivation to substitute one PIK3 inhibitor for a dual PI3K/mTOR inhibitor, wherein targeting two crucial points of the same pathway could lead to higher efficacy, could overcome feedback inhibition coming from mTOR inhibition, and the risk of drug resistance that should easily come out in the case of treatment with compounds targeting a single p110 isoform, wherein dual PI3K/mTOR inhibitors have shown, at least in the preclinical setting, an improved than what achieved targeting individually single PI3K isoforms, all PI3K isoforms or mTOR. Moreover, "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).
Moreover, Applicants contend that the claimed combination of compound (Ia) with PD-1/PD-L1 antibody has achieved synergistic effects, which cannot be expected on the basis of the three references. In particular, using the data provided in the declaration and Clarke’s synergy calculation for evaluating drug combination effects, Applicants assert that examples 1, 5 and 7-8 of the present application demonstrate the synergistic effects of compound (Ia) and PD-1/PD-L1 antibody.
These arguments have been carefully considered, but are not found persuasive.
First, the Examiner acknowledges and does not dispute Applicants assertion that that examples 1, 5 and 7-8 of the present application demonstrate the synergistic effects of compound (Ia) and PD-1/PD-L1, wherein the PD-1/PD-L1 inhibitors are Nivolumab or RMP1-14. However, the Examiner recognizes that “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)”. In the present case, those of skill in the art recognized that the combination of a dual PI3K/mTOR inhibitor and an immune checkpoint inhibitor such as PD-1/PD-L1 can lead to synergistic inhibition of tumor growth at the time of filing of the invention. For example, Yan et al. (Int. J. Mol. Sci. 2021; 22(10):5207) teaches that inhibition of the PI3K/mTOR pathway suppresses breast cancer growth, enhances anti-tumor immune responses, and works synergistically with immune checkpoint inhibitors (Abstract). As such, there appears to be a reasonable expectations that such synergy would occur. Assuming arguendo that Applicants have established that the results are really unexpected, the Examiner recognizes that the examples do not appear to be commensurate in scope with the claimed invention which encompasses any cancer with 12 different PD-1/PD-L1 inhibitor. See MPEP 716.02(d).
Claim(s) 23-24 remain rejected under 35 U.S.C. 103 as being unpatentable over Kutok, Jeffery (US2019/0216816A1, 2019-07-18, IDS) referred to herein as Kutok in view of Medshine Discovery Inc. (CN105461712A, 2016-04-06, IDS translation provided) referred to herein as Medshine and Trantelli et al. (International Journal of Molecular Sciences 2020; 21: 1060), as applied above to claims 15-22, 25-27 and 28-33, in further view of Jakubowski et al. (J. Clin. Oncol. 2020; 38: TPS4114).
The combination of Kutok in view of Medshine and Trantelli et al. have been discussed above and incorporated herein.
While Kutok contemplates the treatment of colon cancer, Kutok does not specifically select colon cancer.
Jakubowski et al. teach a phase 1/II study of PI3Kinase inhibition with copanlisib combined with the anti-PD-1 antibody nivolumab in relapsed/refractor solid tumors with expansions in MSS colorectal cancer (Title). In particular, Jakubowski et al. teach that multiple studies have shown the impact of the phosphatidylinositol 3-kinase (PI3K) pathway on the tumor microenvironment, and 20% of colorectal cancer (CRC) tumors have an activating mutation of PI3K.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include colon cancer in the method taught by the combination of Kutok in view of Medshine and Trantelli et al. in view of the teachings of Jakubowski et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Jakubowski et al. teach that multiple studies have shown the impact of the phosphatidylinositol 3-kinase (PI3K) pathway on the tumor microenvironment, and 20% of colorectal cancer (CRC) tumors have an activating mutation of PI3K.
In response to this rejection, Applicants contend that Jakubowski discloses colorectal cancer tumor having an activating mutation of PI3K and a study design with copanlisib and nivolumab in colorectal cancer, but is silent on the results on the combination effects of PI3K inhibitor and PD-1 antibody.
These arguments have been carefully considered, but are not found persuasive for the reasons set forth above.
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 15-19 and 22-27 remain and new claims 28-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 8, 16-18 and 23-26 of US Patent No. 12661357 (previously copending Application No. 18/261,832) in view of over Kutok, Jeffery (US2019/0216816A1, 2019-07-18, IDS) referred to herein as Kutok. NOTE: The patent has not yet published so the Examiner is using the claim numbering from the application.
The US Patent claims kits comprising the compound I and methods of treating cancers of the digestive tract system including colon which is wildtype of PIK3CA mutated cancer comprising administering to a patient a therapeutically effective amount of compound I or a pharmaceutically acceptable salt thereof, wherein compound I has the following structure:
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The US Patent does not specifically claim that compound I is used in combination with an Immune checkpoint inhibitor for treating cancer.
Kutok teaches pharmaceutical compositions and methods of treatment comprising administration of the compositions, wherein the composition comprises a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator (Abstract). With regards to the immune checkpoint modulator, Kutok teaches that the immune checkpoint modulator is an inhibitor of PD-1, wherein the inhibitor of PD-1 is an anti-PD-1 inhibitor such as Nivolumab, Pembrolizumab (a humanized antibody), Durvalumab (claims 8-14 of the Kutok). With regards to the cancer, Kutok teaches that cancer includes, but is not limited to, solid tumors such as colon and cancers of hematopoietic origin such as lymphoma and leukemia (paragraph 0130). For example, Kutok teaches a phase 1b clinical trial for treatment of patients with hematological malignancies (follicular lymphoma, DLBCL and T-cell lymphoma) comprising administering a combination of compound 1 (a PI3K inhibitor) and an anti-PD-1 antibody (Nivolumab and Pembrolizumab) (Example 2). In addition to the pharmaceutical compositions comprising a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator, Kutok teaches kits, wherein the kits comprise the pharmaceutical compositions comprising a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator or alternatively, the kits are provided as separate pharmaceutical compositions in separate containers within the kit (paragraphs 0623-0625).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition as claimed by the US Patent to further include an immune checkpoint inhibitor such as a PD-1 antibody in view of the teachings of Kutok. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Kutok teaches methods of treating cancer comprising administering a PI3K inhibitor in combination with a PD-1 antibody.
Moreover, "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)
In response to this rejection, Applicants assert, based on the same reasons stated above, all claims are non-obvious in view of copending Application No 18/261,832 and Kutok.
These arguments have been carefully been considered, but are not found persuasive for the reasons set forth above and incorporated herein.
Claims 15-19, 22 and 25-27 remain and new claims 28-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of US Patent No. 12622912 (previously copending Application No. 18/260472) in view of over Kutok, Jeffery (US2019/0216816A1, 2019-07-18, IDS) referred to herein as Kutok.
The US Patent claims methods of treating cancers including endometrial, cervical and ovarian which are PIK3CA mutated cancers comprising administering to a patient a therapeutically effective amount of compound I or a pharmaceutically acceptable salt thereof, wherein compound I has the following structure:
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The US Patent does not specifically claim that compound I is used in combination with an Immune checkpoint inhibitor for treating cancer.
Kutok teaches pharmaceutical compositions and methods of treatment comprising administration of the compositions, wherein the composition comprises a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator (Abstract). With regards to the immune checkpoint modulator, Kutok teaches that the immune checkpoint modulator is an inhibitor of PD-1, wherein the inhibitor of PD-1 is an anti-PD-1 inhibitor such as Nivolumab, Pembrolizumab (a humanized antibody), Durvalumab (claims 8-14 of the Kutok). With regards to the cancer, Kutok teaches that cancer includes, but is not limited to, solid tumors such as colon and cancers of hematopoietic origin such as lymphoma and leukemia (paragraph 0130). For example, Kutok teaches a phase 1b clinical trial for treatment of patients with hematological malignancies (follicular lymphoma, DLBCL and T-cell lymphoma) comprising administering a combination of compound 1 (a PI3K inhibitor) and an anti-PD-1 antibody (Nivolumab and Pembrolizumab) (Example 2). In addition to the pharmaceutical compositions comprising a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator, Kutok teaches kits, wherein the kits comprise the pharmaceutical compositions comprising a phosphatidylinositol 3-kinase inhibitor in combination with an immune checkpoint modulator or alternatively, the kits are provided as separate pharmaceutical compositions in separate containers within the kit (paragraphs 0623-0625).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition as claimed by the US Patent to further include an immune checkpoint inhibitor such as a PD-1 antibody in view of the teachings of Kutok. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Kutok teaches methods of treating cancer comprising administering a PI3K inhibitor in combination with a PD-1 antibody.
Moreover, "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)
In response to this rejection, Applicants assert, based on the same reasons stated above, all claims are non-obvious in view of copending Application No 18/260,472 and Kutok.
These arguments have been carefully been considered, but are not found persuasive for the reasons set forth above and incorporated herein.
Conclusion
Therefore, No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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