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 .
According to a preliminary amendment filed on Nov. 6, 2023, the applicants have canceled claims 2-46.
Claim 1 is pending in the application.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Govindan (J. of Thoracic Oncol.).
Govindan discloses treating non-small cell lung cancer by administration of AMG 510 (instant compound A). Administration of AMG 510 for treating non-small cell lung cancer disclosed by Govindan anticipates the instant claim when the doses of AMG 510 are 180 mg, 360 mg, 720 mg or 960 mg in the instant claim.
Claim 1 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Canon (Nature).
Canon discloses treating non-small cell lung cancer by administration of AMG 510 (instant compound A). Administration of AMG 510 for treating non-small cell lung cancer disclosed by Canon (see evidence of clinical activity on page 220) anticipates the instant claim when the doses of AMG 510 are 180 mg or 360 mg in the instant claim.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,426,404. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the cited patent anticipates the instant claim when the dose of compound A is 960 mg.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 17/696,758 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of the cited application anticipates the instant claim when the dose of compound A is 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31 of copending Application No. 18/270,581 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 31 of the cited application anticipates the instant claim when the dose of compound A is 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 2 of copending Application No. 18/562,107 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of the cited application anticipate the instant claim when the dose of compound A is 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 51 of copending Application No. 18/689,716 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 51 of the cited application anticipates the instant claim when the dose of compound A is 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 3 of copending Application No. 18/872,959 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3 of the cited application anticipate the instant claim when the dose of compound A is 360 mg or 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/880,867 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of the cited application anticipates the instant claim when the dose of compound A is 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/097,649 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the cited application anticipates the instant claim when the dose of compound A is 360 mg or 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7 and 10 of copending Application No. 19/309,299 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 7 and 10 of the cited application anticipates the instant claim when the dose of compound A is 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of copending Application No. 19/472,476 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 5-7 of the cited application anticipates the instant claim when the dose of compound A is 960 mg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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