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 .
The rejection under section 112(a) is withdrawn in view of Applicant’s amendments that limit the instant antibodies those with support in the specification. Also, the amendments limit the instant MAP kinase inhibitors to those within the purview of those of ordinary skill, as per Applicant’s remarks.
The rejection under section 112(b) is withdrawn in view of Applicant’s amendments deleting references to analogs and derivatives.
The following are new grounds of rejection:
The effective filing date of the instant application is 1/13/2017, which is the filing date of PCT/EP2017/050718. Priority applications US 62/278,283 and PCT/EP2016/066353 do not provide support for the instant MAP kinase inhibitors, such as ERK inhibitors, as generically claimed.
In this regard, WO 2016005593 (WO 593) was excepted under 102(b)(2)(C) in parent application 16/069,395. However, WO 593 has counterpart WIPO docs, US Publications and US Patents with priority dates that are “effectively filed” before the effective filing date (1/13/2017) of the instant application under 102(a)(2), with unknown ownership, and therefore must also be excepted as “commonly owned” under 102(b)(2)(C). The patent families of WO 593 are shown on the next pages:
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Moreover, any of references in the patent families published before 1/13/2017 also qualify as prior art under 102(a)(1) and must also be excepted under 102(b)(1)(A) or 102(b)(1)(B) (e.g., WO 2016005593).
In view of the above, the following new grounds of rejection are now entered:
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.
Claims 1, 10, 11, 13, 14, 25, 30, 32, 33, 35-38, 41, 44, 48-50, 54, 57-60, 64, 66, 67, 68, 78 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015193430 (WO 430, previously cited) in view of Wan et al., Cell, Vol. 116, 855–867, March 19, 2004 (Wan, previously cited) in further view of WO 2016005593 (WO 593), and counterparts (based on the above):
WO 2017009258
US 20180326084
US 20190233522
US 20200397913
US 20170157250
US 10512688
US 20180214549
US 10201607
US 20190275149
US 10765743
US 20190160170
US 10500276
US 20200171152
US 20240091352
WO 430 describes anti AXL antibodies and ADC’s thereof to be used for treating cancers such as melanomas in combination with other chemotherapeutics, such as sorafenib (page 51, § 1, page 52, § 1). WO 430 describes the use of anti-AXL antibody drug conjugates (ADC) to treat cancer including melanomas.
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See page 28
The anti-AXL antibodies were conjugated to MMAE. Combination with agents such as sorafenib is proposed, see pages 51+. In particular, the use of MAP kinase inhibitors or the treatment of melanomas with specific mutations/resistances represent some of several straightforward possibilities from which the skilled person would select, in accordance with circumstances, without the exercise of inventive skill.
With regard to BRAF mutations, there is no particular effect associated with the difference since there is no evidence in the application relating to the treatment of melanomas with the specific mutations or resistances i.e. vemurafenib or dabrafenib etc. Neither there is any evidence that there is a particular effect associated with the difference in the sequences of the antibodies.
The claims require an inhibitor of the MAPK pathway (e.g., B-RAF (BRAF) inhibitor, a MEK inhibitor, or an ERK inhibitor). it is for that proposition the examiner joins Wan et al., Cell, Vol. 116, 855–867, March 19, 2004, which teaches that sorafenib (i.e., BAY43-9006), as taught by WO 430 is a mutant V600E mutant B-Raf inhibitor. Specifically, Wan teaches that BAY43-9006 (Sorafenib, Nexavar) is a V600E mutant B-Raf and C-Raf inhibitor approved by the FDA for the treatment of primary liver and kidney cancer. Bay43-9006 disables the B-Raf kinase domain by locking the enzyme in its inactive form. The inhibitor accomplishes this by blocking the ATP binding pocket through high-affinity for the kinase domain. It then binds key activation loop and DFG motif residues to stop the movement of the activation loop and DFG motif to the active conformation. Finally, a trifluoromethyl phenyl moiety sterically blocks the DFG motif and activation loop active conformation site, making it impossible for the kinase domain to shift conformation to become active. For example:
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In this manner, the applied references provide a reasonable expectation that a combination of anti-AXL ADC’s and B-RAF inhibitors can treat cancer. Specifically, the difference between WO 430 and the claimed inventions is that WO 430 does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, WO 430 teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
WO 430 and Wan may not explicitly teach the instant anti-AXL antibodies. However, these antibodies were known at the time of the invention. WO 593 discloses ADC comprising antibodies to Axl, wherein the antibody can be used in ADC’s wherein the drug is MMAE linked to the antibody through a val-cit. (SEQ ID NO. 1 of the reference contains applicant's CDRs of SEQ ID NO. 36, 37 and 38 and is applicant's SEQ ID NO. 1; SEQ ID NO. 2 of the reference contains applicant's CDRs of SEQ ID NO. 39, GAS and 40 and is applicant's SEQ ID NO. 2; SEQ ID NO. 5 of the reference contains applicant's CDRs of SEQ ID NO. 46, 47 and 48 and is applicant's SEQ ID NO. 5; SEQ ID NO. 4 of the reference contains applicant's CDRs of SEQ ID NO. 49, AAS and 50 and is applicant's SEQ ID NO. 4; SEQ ID NO. 34 of the reference contains applicant's CDRs of SEQ ID NO. 114, 115 and 116 and is applicant's SEQ ID NO. 34; SEQ ID NO. 35 of the reference contains applicant's CDRs of SEQ ID NO. 117, DAS and 118 and is applicant's SEQ ID NO. 35) (see summary, pages 12-15, 22-23, 25, 47, 51, 66-69, 70 and entire reference). Page 53 specifically discloses the ADC of applicant's claims 2-4 and 52).
In this manner, WO 593 demonstrates that the specific anti-AXL antibodies, and ADC’s thereof, covered by the rejected claims were known, and moreover, those of ordinary skill could have used these antibodies in the instant combinations with a reasonable expectation of success. Therefore, using the antibodies covered by the rejected claims in the recited combination for the purpose of treating cancers would have been prima facie obvious.
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, 10, 11, 13, 14, 25, 30, 32, 33, 35-38, 41, 44, 48-50, 54, 57-60, 64, 66, 67, 68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 85-93, 95-97, 99-11 of copending Application No. 16/891,796.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, the rejected claims recite methods of treating with a combination of anti-AXL antibodies and MAP kinase inhibitors in a manner that anticipate the rejected claims. Alternatively, the difference between the methods recited in the conflicting claims and those recited by the rejected claims is that the conflicting claims may not recite the instant methods and combinations of anti-AXL antibodies and MAP kinase inhibitors with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646