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 13 January, 2023, is a national stage application of PCT/JP2021/026461, filed 14 July, 2021, which claims foreign benefit of application JP2020-121525, filed 15 July, 2020.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 21 October, 2025, in the matter of Application N° 18/016,103. Said documents have been entered on the record.
Claim 24 is amended. Claims 25-35 and 38-48 are canceled. Claim 49 is new. No new matter is introduced.
Thus, Claims 24, 36-37, and 49 represent all claims currently under consideration.
Response to Amendment/Arguments
Claims 25-35 and 38-48 have been canceled. Therefore, the previous rejections of these claims are moot.
Applicant's arguments filed 21 October, 2025 have been fully considered but they are not persuasive.
The instant application now claims methods of treating diseases associated with EGFR by administering a compound selected from (1)-(3), each of which is a species fully encompassed by the broader genus recited in the claims of Patent ‘207, and Copending Applications ‘616 and ‘058. A claim to a specific species is not patentably distinct from a claim to the genus that encompasses it, even if the earlier claims are directed to compositions or methods of treatment that do not explicitly name the species, provided that the species falls within the scope of the prior genus. The same reasoning applies where the earlier claims are to compositions or compounds and the later claims are to methods of using those compositions for the same purpose.
Applicant contends that Patent ‘207 is limited to compounds, compositions, and tumor-treatment methods that do not specifically list compounds (1)-(3) (Remarks, Pg. 5.) However, ‘207 claims and enables a genus encompassing the three presently claimed species, and its method claims are directed to the same therapeutic purpose (treatment of tumors). A later claim to the specific species for the same therapeutic use does not present a patentably distinct invention, as it represents merely an obvious variation of the earlier claimed genus and its use. Furthermore, although the specification of the reference patent discuss the compound’s potential mechanism of action as HER2 (which are of the same family of receptors and same cell signaling pathways as instantly claimed EGFR/HER1, though with different functions), the claims do not recite such a limitation. Accordingly, these differences in the specification do not render the claims patentably distinct from those of the reference patent.
Applicant argues that the copending claims for Application ‘616 do not explicitly recite EGFR or the same three compounds, and that they require an “anti-tumor agent” in combination (Remarks, Pg. 5-6.) However, the co-pending application’s claims are drawn toward the same therapeutic utility (treatment of tumors). The mere addition of another anti-tumor agent, or omission of the specific EGFR mechanistic language, does not render the claimed invention patentably distinct. Both sets of claims are directed to the same inventive concept – anti-tumor therapy using members of the same compound genus.
The ”for use in” language of the copending claims and the “method of treating” language of the instant claims are not meaningfully distinct for ODP purposes, as each defines a therapeutic use of the same compounds.
Applicant’s assertion that the compound of copending Application ‘058 is different is not persuasive. The record shows that compound (2) in the instant claims is the same compound disclosed in Claim 1 of ‘058, and is directed to a method for treating cancer with an aberration in EGFR. Furthermore, the filing sequence is not dispositive. The purpose of ODP is to prevent unjustified patent term extension, regardless of which application issues first. If the application were otherwise in condition for allowance, the ODP could have been applied in the later filed application, however, that is not the case here.
Accordingly, the previously applied non-statutory double patenting rejections are maintained, as the presently pending (i.e. non-canceled) method claims remain patentably indistinct from the claims of the previous patent and copending applications previously cited.
Double Patenting (MAINTAINED)
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 24, 36-37, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-11 and 14-19 of U.S. Patent No. US 11,078,207 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are directed to the same compound genus and to methods of treating a tumor by administering compounds of said genus. Further, although the specification of the reference patent discuss the compound’s potential mechanism of action as HER2 (which are of the same family of receptors and same cell signaling pathways as instantly claimed EGFR/HER1, though with different functions), the claims do not recite such a limitation. Accordingly, these differences in the specification do not render the claims patentably distinct from those of the reference patent.
Claims 24, 36-37, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-5, 8, and 14-17 of copending Application No. 18/015,616 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application are directed to antitumor compositions and methods comprising compounds of the same genus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 24, 36-37, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4-8, 10-13 of copending Application No. 18/563,058 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application are directed to a method of treating EGFR linked cancer comprising a compound of the same genus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627