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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 recites wherein the lung cancer is small cell lung cancer. However, the working examples in the specification (page 549-565) are limited to non-small cell lung cancer models, including NCI-H1975 xenograft model and engineered BaF3 EGFR-mutant model. It is well known in the art that non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) are not the same, because they are distinct diseases that differ significantly in how they grow, spread, and respond to treatment. In this light, the specification fails to provide appropriate experimental data, or guidance demonstrating that the claimed compounds would be effective against or treating SCLC. For this reason, a person of ordinary skill in the art (POSITA) would be required to perform undue experimentation to determine whether the claimed compound is effective for treating SCLC. Therefore, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to claim a method of treating SCLC.
Written Description
Claim 1 recites compounds of formula I defined by multiple independently variable substituents, which encompasses substantial number of structurally distinct compounds. The specification does not provide representative examples spanning the breadth of the claimed substituents within the claimed genus. This is because the specification only provides data primarily for compound 1 and, to a more limited extent, compound 2. Not to mention that the data indicate that compound 1 and 2 exhibit different tumor volume reduction profiles, demonstrating variability in biological performance even among the limited species tested (see, e.g., Figure 3 and 4). Thus, such differences underscore the unpredictability of structure-activity relationships within the claimed genus. For this reason, claiming compounds of formula I requires more than two representative compounds to demonstrate that the genus is effective.
Furthermore, claim 1 discloses a genus of compounds defined by a Markush formula in which B* moiety is aryl or heteroaryl rings optionally substituted with a broad list of substituents. However, the specification provides only a limited number of examples in which, for example, B* moiety is exemplified as a thiazole or pyridine rings bearing no substituents. The specification does not disclose a representative number of species of B* moiety comprising the breadth of the claimed substituents. The same deficiency is present in the benzyl oxindole and cyclopenta-imidazol moieties comprising (R31)y and R32, and R33 substituents, respectively. For example, the specification provides only examples of benzyl oxindole bearing a fluorine substituent, which does not adequately reflect the full scope of the claim for benzyl oxindole bearing (R31)y and R32 substituents. Thus, the limited disclosure of the claimed invention does not provide adequate support for the full scope of the claimed genus.
Claim 18 recites “wherein the EGFR mediated cancer is adenocarcinoma.” Adenocarcinomas are highly heterogenous tumors defined by distinct genetic mutations and molecular pathway. It is well established in the art that different subtypes of adenosarcomas can respond differently to therapy and may require different chemotherapies or hormone treatments. EGFR mutation can define a specific subtype of adenocarcinoma, but the specification does not provide evidence identifying this subtype nor demonstrating that the claimed compounds are effective against it. The specification does not provide representative examples, experimental data, or other technical description demonstrating that EGFR mediates specific tumor growth across the full breadth of adenocarcinomas encompassed by the claim. The disclosure does not show pathological evidence of tumor appearance, or biopsy or surgical sample—showing malignant cells forming glandular structures which often require to generally require to establish such a claim of adenocarcinomas. Thus, merely reciting the broad category “adenocarcinmoas” without identifying representative species that were treated with the claimed compound.
Claim 19 recites a broad and heterogenous class of cancers that differ substantially from one another. The specification, however, only provides experimental data limited to lung cancer models, specifically non-small cell lung cancer. There is no vivo or in vitro models are disclosed for the majority of the recited cancer types. The specification does not provide representative disease models, efficacy data, or mechanistic explanation demonstrating that the claimed compounds are effective across the full scope of cancer types. The listed cancers encompass multiple tissue origins, histological subtypes. The specification does not disclose representative species of treatment across the breadth of the claimed cancer types.
Claims 20-24 recites the methods of treating EGFR-mediated breast cancers, including HER-2 positive, estrogen receptor positive, progesterone receptor positive and triple negative breast cancer. However, the specification does not provide sufficient description of treatment with the claimed compound with the various subtype of breast cancer. The specification does not provide any data in breast cancer models, such as HER-2 positive, estrogen receptor positive, progesterone receptor positive and triple negative breast cancer cell lines or xenografts, demonstrating that the claimed compounds effectively against those subtypes. The specification does not provide guidance that would allow a person of ordinary skill in the art (POSITA) to reasonably predict efficacy across the full range of the recited breast cancer subtypes without undue experimentation.
Claims 25, 29-30 recite treatment of relapsed and/or refractory, and parenteral administration, including intravenously. The specification does not provide disclosure, representative examples, of experimental evidence demonstrating that the compounds are effective against relapsed or refractory cancers, nor does it describe parenteral or intravenous administration of the compounds. Thus, the specification does not convey possession of method of treating relapsed and/or refractory EGFR-mediated cancers or parenteral or intravenous administration
The specification’s failures to disclose a proper representative number of species across the claimed genus, and provide direction or guidance for the use thereof supports the conclusion that the specification lacks adequate written description of the claimed subject matter indicating that Applicant was not in possession of the entirety of the claimed genus at the time of filling of the instant application in view of the disclosure of the application as filed.
Subject Matter Free of the Art of Record
The subject matter of claim 1 is free of the art of record, and all claims that are directly or indirectly depend on claim 1. The closest prior art is the Duplessis et al. WO2020002487. While Duplessis teaches compound of formula I, however there is no motivation for an ordinary skill in the art to modify the teaching of Duplessis to arrive at the claimed compound. These claims are not allowable until the 112 and double-patenting rejection are overcome.
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 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. US11,673,902.
Although the claims at issue are not identical, they are not patentably distinct from each
other because compounds claimed in US patent ‘902 are comparable 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. Given U.S patent ‘902 and instant application describe the same compound for the same therapeutic purpose, thus the method claims are not patentably distinct. Allowing the instant claims would effectively extend the patent term for the same invention already patented.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. US 12371442.
Although the claims at issue are not identical, they are not patentably distinct from each
other because compounds claimed in US patent ‘442 are comparable 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 degrade 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 that of the instant claims. Given U.S patent ‘442 and instant application describe the same compound for the same therapeutic purpose, thus the method claims are not patentably distinct. Allowing the instant claims would effectively extend the patent term for the same invention already patented.
Conclusion
Therefore, claims 1-30 are rejected.
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).
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622