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 . Claims included in the prosecution are claims 1-10.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Eich et al. (EZH2-Targeted Therapies in Cancer: Hype or Reality, Dec. 15, 2020) (hereinafter Eich) in view of Jeon et al. (US 2022/0117961, Filing date: Oct. 16, 2020) (hereinafter Jeon).
Eich discloses wherein EZH2 is overexpressed in numerous tumor entities and is associated with aggressive disease, leading to its classification as an oncogene (page 5450, Aberration of EZH2 Signaling in Cancer, first paragraph). Valemetostat Tosylate (DS-3201b) is a EZH1/2 dual inhibitor that has demonstrated synthetic lethality in malignancies overexpressing EZH2 (page 5252, left column, third paragraph). Valemetostat tosylate is in a clinical trial for treating Adult T-cell leukemia/lymphoma (Table 1).
Eich differs from the instant claims insofar as not disclosing a pharmaceutical composition comprising valemetostat tosylate.
However, Jeon discloses a pharmaceutical composition comprising compounds that are useful for presenting and/or treating a disease, or disorder, or condition relating to cancer (¶ [0038]). The pharmaceutical composition comprises one or more pharmaceutically acceptable excipient, including, but not limited to, diluents, disintegrants, and lubricants (¶ [0045]). The diluent may be microcrystalline cellulose (i.e., claimed water-insoluble excipient) (¶ [0052]). The disintegrant may be croscarmellose sodium, sodium starch glycolate, or any combination thereof (¶ [0010]). The composition comprises from about 1 to about 40 wt. % of the disintegrant (¶ [0009]). The pharmaceutical composition may be in the form of a solid oral dosage. The solid preparation may be a tablet coated with a film-coating agent (¶ [0073]). The film-coating agent may be Hypromellose (¶ [0074]).
Eich does not disclose how valemetostat tosylate is administered. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the pharmaceutical composition of Jeon as the carrier for valemetostat tosylate since valemetostat tosylate treats cancer and the pharmaceutical composition of Jeon is a known and effective carrier for compounds that are useful for treating cancer as taught by Jeon.
Conclusion
Claims 1-10 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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