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 .
Priority
This application is a 371 of PCT/JP2021/015032 (04/09/2021) and claims foreign priority to JAPAN 2020-071355 (04/10/2020).
Status
Claims 19-22, 30-43 are pending. Claims 30-43 were newly presented.
Rejections not reiterated in this action are withdrawn.
New Claim Rejections - 35 USC § 103
Claims 19-22, 32-35, 37-39, 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA.
Miura teaches a method for treating a tumor comprising administering a combination of the FGFR inhibitor, (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)pyrrolidin-1-yl)prop-2-en-1-one (claim 2; aka “TAS-120”), and second compound having an antitumor effect, including molecular targeting drugs, which Miura teaches includes trametinib (claim 10; [0162]: “low-molecular-weight molecular targeting drugs such as … trametinib”). Miura teaches the daily dose is 10 to 40 mg per day ([0191]).
Regarding claim 19, although Muira teaches a dose range, Muira does not specifically teach the particular dose as in the claim.
Bockorny teaches combining FGFR inhibitors with MEK inhibitors (Abstract; p. 1534-37), including specifically the MEK inhibitor trametinib (p. 1534). Bockorny experimentally determined that the combination of an FGFR inhibitor with an MEK inhibitor is a robust and power approach in treating resistant cancer (p. 1537: “FGFR inhibition combined with downstream blockade of MEK provides a more robust and powerful approach in preventing resistance across diverse FGFR dependencies and may represent a therapeutic opportunity to achieve durable responses to FGFR inhibition.”).
One of ordinary skill in the art following the teaching of Miura would reasonably consider combining teachings with Bockorny because they are both in the same field of endeavor cancer therapy with FGFR inhibitors. Base on the specific teaching and success of Bockorny to combine FGFR inhibitors with MEK inhibitors, one of ordinary skill in the art would have had a reasonable expectation of success in selecting the combination of TAS-120 and trametinib. Thus, it would have been prima facie obvious to combine TAS-120 with an MEK inhibitor of trametinib for the purpose of treating tumors and arrive at the claimed invention.
Regarding the dose, one of ordinary skill in the art would know that a pharmaceutical dose is a result effective variable and is routinely optimized to maximize therapeutic effect as taught by Miura ([0189]-[0193]). Thus, one of ordinary skill in the art would have been motivated to optimize the dosage and would have arrived at the claimed invention with a reasonable expectation of success, particularly in view of dosing range taught by Miura. See MPEP 2144.05 (“Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”).
Regarding claim 20, Muira teaches a method of treating a tumor in a patient by administering the combination of therapeutics in the same manner.
Regarding claim 21-22, Muira teaches a method of treating a tumor in a patient by administering the combination of therapeutics in the same manner and would have also considered enhancing the antitumor effect of an MEK inhibitor in view of the teaching of Bockorny’s success with the combined blockade.
Regarding claim 32, Muira teaches “administered simultaneously, separately, or sequentially” (claim 18).
Regarding claims 33, 37, 41, Muira teaches that the MAPK signalling pathways are aberrantly activated in cancer cells ([0167]) and one of ordinary skill in the art would have considered use on the same cancers.
Regarding claim 34-35, 38-39, 42-43, Muira teaches the combination for treating lang cancer tumor (claim 28).
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of therapeutics to improve efficacy. Thus, the claims are prima facie obvious.
Claims 30-31, 36, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as applied to claims 19-22, 32-35, 37-39, 41-43 above and further in view of FDA (MEKINIST® (trametinib) Label, Revised 10/2019, retrieved from https://www.fda.gov/drugsatfda on 2026-02-12, 36 pages).
Regarding claims 30-31, 36, 40, Muira does not teach the trametinib dose, however, one of ordinary skill in the art would have considered administering the FDA approved dosage of 2mg (FDA p. 1). Regarding the dose, one of ordinary skill in the art would know that a pharmaceutical dose is a result effective variable and is routinely optimized to maximize therapeutic effect as taught by Miura ([0189]-[0193]). Thus, one of ordinary skill in the art would have been motivated to optimize the dosage and would have arrived at the claimed invention with a reasonable expectation of success, particularly in view of the approved dose of FDA. See MPEP 2144.05.
Response to Remarks - 35 USC § 103
Regarding Bockorny, Applicant argues that the reference merely discloses combination of different FGFR inhibitors with trametinib, but does not disclose or suggest a combination therapy.
This argument is not persuasive as Bockorny concludes with: “FGFR inhibition combined with downstream blockade of MEK provides a more robust and powerful approach in preventing resistance across diverse FGFR dependencies and may represent a therapeutic opportunity to achieve durable responses to FGFR inhibition.” One of ordinary skill in the art reading Bockorny, including the numerous experimental results therein, would have considered this a suggestion to combine FGFR inhibitors and MEK inhibitors, specifically trametinib.
New Double Patenting
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 8, 10, 17, 24, 26 of U.S. Patent No. 10835536. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 of U.S. Patent No. 10894048. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10434103. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 10300066. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 10124003. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11833151. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11883404. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11975002. Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the patent has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
Claims 19-22, 30-43 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 21, 31 of copending Application No. 17434655 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the reference application has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-22, 30-43 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 17432158 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the reference application has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-22, 30-43 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 17434573 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are rendered obvious in view of the secondary references Miura et al. (WO2017150725, published 2017-09-08, citations to English equivalent US20200281927), Bockorny et al. (Mol Cancer Ther; 17(7) July 2018, p. 1526-1539), and FDA as detailed in the 35 USC 103 rejection above and incorporated herein. In this case, the reference application has claims drawn to the same compound TAS-120 which anticipates or renders obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims 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.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626