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 .
Priority
This application, filed 8 December, 2023, is a CON of national stage application of PCT/EP2022/065393, filed 7 June, 2022, which claims foreign benefit of Application EP21178403.8, filed 9 June, 2021.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 20 February, 2024, in the matter of Application N° 18/533,622. Said documents have been entered on the record.
Claims 1-5 and 9-21 are amended. Claims 6-8 and 22 are canceled. No new matter was introduced.
Thus, Claims 1-5 and 9-21 represent all claims currently under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 20 depends from Claim 10 but merely restates the structural limitation of the BRAF Inhibitor already recited in Claim 1, from which Claim 10 ultimately depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 3-5 and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art appears to be Zaremba et al. (Onkologe, Springer, Berlin, DE, vol 26, no.8, 27 April, 2020, pages 713-720, DOI: 10.1007/S00761-020-00762-1.) Zaremba teaches the general therapeutic strategy of combining BRAF inhibitors and MEK inhibitors as a targeted therapy for the treatment of metastatic melanoma. However, Zaremba does not teach or suggest the specific BRAF inhibitor defined by Formula I of the instant application, nor the specific MEK inhibitor defined by instant Formula II. The instant claims are directed to combinations comprising these structurally distinct and novel inhibitors.
While the Applicants later individually published applications directed to the separate BRAF inhibitor (e.g., WO 2021/116055 A1 –Hoffman LaRoche) and MEK inhibitor (e.g., WO 2021/149776 A1 – Chugai Pharmaceutical) compounds, those disclosures post-date the effective filing date of the instant application and do not disclose the claimed combination of the two inhibitors.
As such, Zaremba represents the closest known prior art but does not anticipate or render
obvious Claims 3-5 and 21 (if rewritten in independent form) in the present application.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 9-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 19-20 of copending Application No. 18/533,539 and Claim 18 of copending Application No. 19/138,422.
Although the claims at issue are not identical, they are not patentably distinct from each other because each application claims a combination comprising the same compound of Formula I as the BRAF inhibitor, in combination with an anticancer agent.
‘539 claims a combination comprising the same specific BRAF inhibitor in combination with a PD-1 inhibitor, and further comprises additional anti-cancer agents including an EGFR inhibitor and a MEK inhibitor (‘539, Claims 19-20.) ‘422 claims a combination comprising the same BRAF inhibitor of Formula I and an EGFR inhibitor, and further comprises additional anti-cancer agents including a PD-1 inhibitor or a MEK inhibitor (‘422, Claim 18.)
The copending applications collectively claim combinations centered on the same specific BRAF inhibitor in combination with PD-1 inhibitors, MEK inhibitors, and EGFR inhibitors, including claims that expressly contemplate the addition of the other recited agents. The instant claims merely select one of the expressly disclosed and claimed combination permutations. The differences between the claimed subject matter do not amount to a patentably distinct invention but instead represent obvious variations within a finite and predictable set of combination therapies involving the same core compound and overlapping anti-cancer agents.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627