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.
Applicants' arguments, filed 08/10/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Response to Arguments
Applicant argues that Jeon relates specifically to pharmaceutical compositions comprising phthalazinone derivatives and is concerned with maintaining stability of that specific API; not valemetostat tosylate. Valemetostat toysylate is not a phthalazione derivative, nor is it structurally similar.
The Examiner does not find Applicant’s argument to be persuasive. Valmetostat toysylate was known in the art to treat cancer as taught by Eich. The art does not disclose how to administer valemetostat tosylate. Therefore, one of ordinary skill in the art would have looked for suitable carriers for cancer treating actives, such as that of Jeon, which discloses a carrier for compounds that are useful for presenting and/or treating a disease, or disorder, or condition relating to cancer. Applicant has not explained why the carrier of Jeon would not be suitable or effective for valemetostat tosylate. The carrier of Jeon maintaining the stability of phthalazinone derivatives does not mean that the carrier would not be effective with other actives. Jeon does not disclose wherein their carrier is only effective with phthalazinone derivatives as the active. As such, Applicant’s argument is unpersuasive.
Applicant argues that neither Eich nor Jeon is concerned with the specific challenges relating to the dissolution of valemetostat tosylate, and therefore neither reference – either alone or in combination – can provide the requisite reasonable expectation of success required to properly sustain the rejection.
The Examiner does not find Applicant’s argument to be persuasive. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144(IV). Thus, it is not necessary for the prior art to teach solving the same problem as Applicant. Also, Applicant’s showing in the specification appears to show wherein using croscarmellose sodium or sodium starch glycolate is advantageous over other disintegrants. This result does not appear to be unexpected since Jeon discloses using croscarmellose sodium as the disintegrant in Example 16 and sodium starch glycolate as the disintegrant in Example 17. Applicant has not shown wherein using these disintegrants with valemetostat tosylate is unexpected and one would not see similar results using a different active ingredient. As such, Applicant has not shown wherein the claimed invention is unexpected and Applicant’s argument is unpersuasive.
Conclusion
Claims 1-10 are rejected.
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614
Prosecution Insights