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 .
DETAILED ACTION
1. Claims 9-10 are pending in the current application.
2. This application is a CON of 17/869,226 07/20/2022 PAT 11964950; 17/869,226 is a CON of PCT/JP2021/002088 01/21/2021; FOREIGN APPLICATIONS: JAPAN 2020-008757 01/22/2020.
Response to Amendments
3. The rejections of canceled claims are withdrawn. The rejection of claims 7-10, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn based upon the amendments. The rejection of claims 9-10 provisionally on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15-19, 21-23 of copending Application No. 18/016,691 is maintained. Applicants’ representative’s arguments submitted on August 18, 2025 have been fully considered but are unpersuasive. The rejection of claims 9-10 on the ground of nonstatutory double patenting as being unpatentable over claims 11, 15, 19, 23 of U.S. Patent No. 11,964,950 is maintained. Applicants’ representative’s arguments submitted on August 18, 2025 have been fully considered but are unpersuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
4. Claims 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15-19, 21-23 of copending Application No. 18/016,691. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a composition of the compounds in the method of the instant claims. One could not practice the method of the instant claims without those compounds. The method of the instant claims is disclosed in the specification of the ‘691 application, on page 72 where the MEK-inhibiting activity is disclosed. According to page 41, “the method comprising administering the composition.”. Page 92 explains effective amounts, “ When a compound, salt or solvate of the present disclosure is to be used for the treatment or prevention of a cell proliferative disorder, the dose and dose interval may be determined as appropriate depending on, for example, the severity of symptoms, the age and body weight of the subject, the presence or absence of a concomitant drug, and the route of administration. For example, when the subject is a human, a compound, salt or solvate of the present disclosure will usually be administered once every day to every three weeks at a dose of 0.00001 to 5000 mg per kilogram of body weight, preferably 0.01 to 100 mg per kilogram of body weight. When it is administered daily, the dose mentioned above may be divided into 2 to 4 separate doses. [0131] With regard to the route of administration to a subject, there may be used, for example: systemic administration such as oral administration, rectal administration, intravenous administration, intramuscular administration, subcutaneous administration, intracisternal administration, vaginal administration, intraperitoneal administration, intravesical administration, or inhalation administration; or topical administration in the form of an ointment, gel or cream. Oral administration is preferred.” According to page 3 paragraph [0008] the compounds “it has been found that specific aryl amide derivatives (compounds, salts or solvates according to (Al) to (A16)and (B1)) to (B3) below) have RAF/MEK complex-stabilizing activity”. Page 8 also “[0038] The compounds, salts or solvates of (A1) to (A16) exhibit high RAF/MEK complex-stabilizing activity and can be used as active ingredients in therapeutic or prophylactic agents for cell proliferative disorders, particularly cancers (more specifically, RAS-mutant cancers).” Page 10 “[0050] According to the present disclosure, there is provided a composition comprising a specific aryl amide derivative that has RAF/MEK complex-stabilizing activity and/or MEK-inhibiting activity and is useful for the treatment or prevention of a cell proliferative disorder, particularly a cancer…” Such a disclosure in the specification makes the method obvious over the composition claims; see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). As per MPEP 804 II. (B) (2) (a): “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).” In Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003), the earlier patent claimed a compound and the written description disclosed the utility of that compound. The later patent claimed nothing more than the earlier patent’s disclosed utility as a method of using the compound. Thus, the court found that the claims of the later patent and the claims of the earlier patent were not patentably distinct. The instant application is not related to the application and as such the safe harbor provision of 35 U.S.C 121 does not apply to this relationship. With respect to specific excipients listed in the copending claims, these are the excipients in the instant specification on pages 75-77.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5. Claims 9-10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 15, 19, 23 of U.S. Patent No. 11,964,950. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘950 patent are drawn to treating cancer in a subject with the claimed compounds. The instant “method of stabilizing the RAF/MEK complex” is an inherent consequence of the administration of the compounds and is not a patentable distinction.
Conclusion
6. 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 DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621