DETAILED ACTION
This action is in response to Applicant’s submission dated September 5, 2023, in which Applicant amended claims 3, 5, 7, 9-11, 14-15, 17-25, and 27, and canceled claims 4, 26, and 28-32.
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 .
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Determining the scope and contents of the prior art.
Claims 1-3, 5-25, and 27 are rejected under 35 U.S.C. § 103 as being unpatentable over WO 2019/020559.
WO 2019/020559 discloses a method of treating breast cancer in a patient in need thereof (p. 4, ln. 19-21, “…Herein is also provided a method of treating the pathological conditions indicated above, particularly breast cancer, comprising co-administering to a subject in need thereof palbociclib and compound (1) or a pharmaceutically acceptable salt thereof…”; p. 22, table 1, “…Efficacy of compound (1) combined with palbociclib against subcutaneous MCF7-Y537S human breast cancer xenograft in nude mice…”), comprising orally administering to the patient amcenestrant, or a pharmaceutically acceptable salt thereof (p. 16, example 2, ln. 6-10, “…The treated groups included compound (1) at 5 mg/kg alone, palbociclib at 100 mg/kg alone, and the combination of compound (1) and palbociclib at the same dose and regime.
Ascertaining the difference between the prior art and the claims at issue.
Compound (1) was orally dosed twice a day (BID)…”; p. 22, table 1, row 4, “…Compound (1) + Palbociclib…”; it is understood that compound (1) is amcenestrant, see p. 1, ln. 13-14, “…6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidine-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid…”) and orally administering to the patient palbociclib, or a pharmaceutically acceptable salt thereof, at a dose of 75-125 mg. once daily (pages 4, ln. 19-21, “…Herein is also provided a method of treating the pathological conditions indicated above, particularly breast cancer, comprising co-administering to a subject in need thereof palbociclib…”; p. 16, example 2, ln. 6-10, “…palbociclib at 100 mg/kg alone, and the combination of compound (1) and palbociclib at the same dose and regime … and palbociclib was orally dosed once a day (QD) for 30 days…”; p. 22, table 1, row 4, “…Compound (1) + Palbociclib…”), but does not disclose wherein the dose of amcenestrant is more specifically 200-400 mg once daily. It would have been obvious to a medicinal chemist of ordinary still in the relevant art; however, to optimize the dose of amcenestrant to be 200-400 mg once daily through routine experimentation.
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here. The specific dosage range of amcenestrant of 200-400 mg once daily is a very finite list and Applicant was not left to pick and choose from a generic disclosure.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
In the absence of any substantiated unexpected property of the claimed dose of amcenestrant in the specific range of 200-400 mg once daily combined with palbociclib in the dosage range of 75-125 mg once daily, then non-obviousness cannot be acknowledged for the claimed subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932