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 .
Status of claims
Pending claims 1-3, 5-7, 12-14, 16, 25-28, 31-33 have been examined on the merits.
Withdrawn Rejections
The rejection of claim 17-24 and 29-30 under 35 U.S.C. 112(a) is withdrawn in view of the claim cancellation.
The rejection of claims 1-3, 5-7, 12-14, 16, 25-28 under 35 U.S.C. 112(a) is withdrawn in view of the claim amendment and applicant’s argument.
Subject Matter Free of the Art of Record
The subject matter of claim 1 is free of the prior art, and all claims that are directly or indirectly dependent on claim 1. The closest prior art is the Duplessis et al. WO 2020/002487. While Duplessis teaches a compound of formula I, the prior art fails to teach every component of the claimed compound, as key components such as glutarimide is absent, as an example. Additionally, there is no motivation for a person of ordinary skill in the art to modify the teachings of Duplessis to arrive at the claimed compound. These claims will not be allowable until non-statutory double-patenting rejections are overcome.
New Grounds of Rejection due to claim amendment
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 1-3, 5-7, 12-14, 16, 25-28, 31-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,673,902 in view of Tsai et. al., Sci. Rep. 5, 13574 (2015).
Although the claims at issue are not identical, they are not patentably distinct from each
other because compounds claimed in US patent ‘902 are substantially identical to those of the instant claims.
For example, claims 1-29 of the US patent ‘902 recite compounds of formula or pharmaceutically acceptable salt thereof that degrade the epidermal growth factor receptor (EGFR) that are useful to treat various cancers, reading on instant claims. US patent ‘902 discloses a genus of EGFR-degrading compounds defined by substantially identical structural limitation of the instant claims.
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US patent ‘902 further claims pharmaceutical compositions comprising the same compounds and formulations for oral, intravenous, and parenteral administration as that of the instant claims. Please note, the US patent claims compounds and pharmaceutical composition comprising PROTACs compounds, whereas the instant application claims method of treating a brain or central nervous system metastasis of an EGFR mediated cancer in a human patient. However, although the US patent ‘902 does not disclose any therapeutic use, it is therefore necessary and permissible to consult the specification to ascertain the contemplated use of the compound, among those in treating L858R-mutant EGFR non-small cell lung cancer (see MPEP 804 II.B.1.) The US patent ‘902 specification (col. 52, line 1-7 and 14-18; col. 40, line 52-63; col. 41, line 10-27; col. 16, line 23-36) discloses that the compounds are useful to treat L858R-mutant EGFR cancer, including non-small lung cancer. Furthermore, Tsai (page 1-2) discloses that EGFR-L858R is a recognized and clinically relevant mutation in non-small cell lung cancer. Therefore, a POSITA would have understood from the US patent ‘902 disclosure in view of Tsai’s teachings, that the compounds of the US patent were intended for use in treating the L858R-mutant EGFR mediated cancer, particularly L858R-mutant non-small lung cancer, thereby arriving at the claimed invention. Therefore, allowing the instant claims would effectively extend the patent term for the same invention already patented.
Claims 1-3, 5-7, 12-14, 16, 25-28, 31-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,371,442 in view of Tsai et. al., Sci Rep 5, 13574 (2015).
Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds claimed in US patent ‘442 are substantially identical to those of the instant claims.
For example, claims 1-29 of the US patent ‘442 recite compounds of formula or pharmaceutically acceptable salt thereof that degrades the epidermal growth factor receptor (EGFR) that are useful to treat various cancers, reading on instant claims. US patent ‘442 discloses a genus of EGFR-degrading compounds defined by substantially identical structural limitation of the instant claims.
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US patent ‘442 further claims pharmaceutical compositions comprising the same compounds and formulations for oral administration as those of the instant claims. Note that, the US patent ‘442 claims method of treating EGFR mediated cancer, including non-small cell lung cancer and small-cell lung cancer, whereas the instant application claims method of treating a brain or central nervous system metastasis of an EGFR mediated cancer in a human patient (see US patent ‘442, claims 1, 24 and 27). However, the US patent ‘442 claims do not disclose treating mutant-EGFR mediated cancer. Although the US patent ‘442 does not disclose treating EGFR-mutant cancer, it is therefore necessary and permissible to consult the specification to ascertain whether the contemplated treatment may include L858R-mutant EGFR non-small cell lung cancer (see MPEP 804 II.B.1.) The specification of US patent ‘442 (col. 41, line 15-45; col. 16, line 60-67; col. 15, line 59-67) discloses that the compounds can be used to treat L858R-mutant EGFR cancer, including non-small cell lung cancer. Furthermore, Tsai (page 1-2) discloses that EGFR-L858R is a recognized and clinically relevant mutation in non-small cell lung cancer. Therefore, it is prima facie obvious to combine the teachings of US patent ‘442 and Tsai to apply the compound disclosed in the US patent ‘442 to L858R-mutant EGFR cancer, including non-small cell lung cancer with expectation of success to arrive at the claimed treatment. Therefore, allowing the instant claims would effectively extend the patent term for the same invention already patented.
Response to argument
Rejection under 35 USC §112(a)
Applicant’s argument regarding the 112 rejection is persuasive, thus the rejection is withdrawn.
Nonstatutory double patenting
Applicant argues that the US patents are not obvious over the presently claimed invention because the treatment method claimed in the US patent was not directed to treating brain or central nervous system metastasis of an L858R-mutant EGFR-mediated cancer in human. Applicant’s argument is not persuasive. The US patent and instant invention claim the same compound, for treating EGFR-mediated cancer, which provides a substantial overlap with the claimed invention. Furthermore, as indicated above, when the specification is considered, both US patents expressly disclose use of the same compound for treating L858R-mutant EGFR cancer, including L858R-mutant non-small lung cancer. Thus, a POSITA would reasonably infer that the instant invention is an obvious modification of the US patent, disclosing the same compound for the same general therapeutic utility intended by the claimed invention, for instance treating L858R-mutant EGFR mediated cancer and L858R-mutant non-small cell lung cancer. Furthermore, Applicant has not established that treating CNS or brain metastasis represents a separate invention, which requires materially different method of treatment than the US patent. Therefore, allowing another patent claiming demonstration of the same compound for treatment of selected subpopulation of the same EGFR-mediated cancer disease would improperly provide an unjustified extension of the right to exclude.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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