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/EP2022/059700 (04/12/2022)
And claims foreign priority to EP 21315064.2 (04/12/2021).
Drawings
The drawings filed 10/11/23 are objected to for not conforming to the requirements of 37 CFR 1.84(u)(1) (“View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.”). MPEP 608.02.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18, 20-25, 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Harmon et al. (WO2021/178846, EFD 2020-03-06).
Harmon teaches a method treating cancer with an estrogen receptor antagonist SAR439859 (claim 3; also known as amcenestrant – instant Specification p. 1), and further comprising a combination with the CDK4/6 inhibitor including ribociclib (claim 45). Harmon teaches the cancer is breast cancer (claim 88).
Regarding claim 20 specifying the combination shows therapeutic synergy, the wherein clause is expressing the desired result of the method claim and does not alter the steps recited. See MPEP 2111.04 (“the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).”). Regarding claims 21 and 22 specifying treating breast cancer by administering a therapeutically effective amount in combination, Harmon teaches the cancer is breast cancer (claim 88) and that a therapeutically effective amount in combination is administered together ([0070]; [0102]).
Regarding claims 23-24, Harmon teaches “administering a complete estrogen receptor antagonist and an anticancer agent described herein can be administered simultaneously or separately” ([0184]). Regarding claim 25, Harmon teaches “In some embodiments, an anti-cancer agent is administered prior to administration of a complete estrogen receptor antagonist” ([0184]). Regarding claim 30, Harmon teaches “In some embodiments, an anti-cancer agent is administered after administration of a complete estrogen receptor antagonist” ([0184]).
Thus, the claims are anticipated.
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.
Claims 18-37 are rejected under 35 U.S.C. 103 as being unpatentable over Harmon et al. (WO2021/178846, EFD 2020-03-06).
Harmon renders obvious claims 18, 20-25, 30 as detailed in the 35 U.S.C. 102(a) supra and incorporated herein. One of ordinary skill in the art following the teaching of Harmon would have considered the specific teaching of treating cancer with the combination of amcenestrant with ribociclib both of which were known for the purpose of treating cancer and arrive at the claimed invention with 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 reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); MPEP 2144.06.
Regarding claim 19 specifying ribociclib succinate salt, Harmon teaches formulation using well-known pharmaceutically acceptable salts, including specifically succinate ([0083]) which one of ordinary skill in the art would have considered and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 26 specifying a composition comprising amcenestrant, ribociclib, and a pharmaceutically acceptable excipient, Harmon teaches simultaneous administration ([0184]) and formulation with pharmaceutically acceptable excipient ([0073], [0081]-[0082]) which one of ordinary skill in the art would have considered routine formulation of a combination therapy and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 27 depending from claim 26 and specifying ribociclib succinate salt, Harmon teaches formulation using well-known pharmaceutically acceptable salts, including specifically succinate ([0083]) which one of ordinary skill in the art would have considered and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 28-29 specifying administering the composition of claim 27, Harmon teaches treating breast cancer by administering the compounds (claim 88) which one of ordinary skill in the art would have considered and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 31 specifying the patient is on a stable treatment with amcenestrant and administering ribociclib, Harmon teaches administration of amcenestrant alone (claim 3) and in combination which one of ordinary skill in the art would have considered adding the ribociclib anti-cancer therapy to also treat cancer (MPEP 2144.06) and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 32 specifying the administering ribociclib to a patient also being treated with amcenestrant, Harmon teaches administration of amcenestrant alone (claim 3) and in combination which one of ordinary skill in the art would have considered adding the ribociclib anti-cancer therapy to also treat cancer (MPEP 2144.06) and arrive at the claimed invention with a reasonable expectation of success.
Regarding claims 33-37 specifying a “kit” comprising the same components as in the method claims addressed above, one of ordinary skill in the art would consider preparing the obvious pharmaceutical combination as a kit for performing the same method and arrive at the claimed invention with a reasonable expectation of success. Furthermore, the printed matter of package insert is not functionally or structurally related to the substrate as it is instructions on use, thus is not given patentable weight. MPEP 2111.05.
With each of the 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 elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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