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 .
Claims 1-20, 28 and 29 have been canceled. Claims 21-25, 27, 30 and 32 have been amended. Claims 21-27 and 30-33 are pending and under consideration.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21, and 24 rejected under 35 U.S.C. 101 because the claimed invention is directed, in part, to an abstract idea without significantly more.
Claim 21 recites determining whether the tumor exhibits cMet overexpression defined by ≥ 25% of the neoplastic cells have 3+ membrane staining or cytoplasmic staining when measured by IHC, and “if” the tumor tissue exhibits c-Met overexpression administering to the subject (1)Osimertinib and (2) a pharmaceutical composition comprising an anti-Met antibody drug conjugate having the indicated structure and sequence for the anti-cMet antibody. The claim, in part, fails to recite an active method step for the subject whose tumor does not have ≥25% of the neoplastic cells having 3+ membrane and/or cytoplasmic staining. Thus, the claim in part is simply drawn toto the determination of the percentage of neoplastic cells having 3+ membrane and/or cytoplasmic staining. This judicial exception is not integrated into a practical application because for these subjects, because the measurement of c-Met expression is simply a data gathering step. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the subjects are excluded from receiving the inventive combination of Osimertinib and the anti-cMet conjugate.
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Claim 24 recites determining either (i) c-Met overexpression defined by ≥25% of the neoplastic cells having 3+ membrane and/or cytoplasmic staining, or (ii) lack of c-Met expression defined by ≥25% of the neoplastic cells having 3+ membrane and/or cytoplasmic staining, wherein if the tumor tissue exhibits lack of c-Met overexpression the subject is excluded from treatment. The claim, in part, fails to recite an active method step for the subject whose tumor does not have c-Met overexpression defined by ≥25% of the neoplastic cells having 3+ membrane and/or cytoplasmic staining. Thus, the claim in part is simply drawn toto the determination of the percentage of neoplastic cells having 3+ membrane and/or cytoplasmic staining. This judicial exception is not integrated into a practical application because for these subjects, because the measurement of c-Met expression in the neoplastic cells is simply a data gathering step. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the subjects are excluded from receiving the inventive combination of Osimertinib and the anti-cMet conjugate.
Applicant argues that claims 21 and 24 are patent eligible because the existence of population of patients in which no treatment is administered is immaterial to patentability determination under 101. His has been considered but not fond persuasive. Applicant points to example 43 of the October update to patent eligibility guidance wherein a claim drawn to a treatment method comprising calculating a ratio of C11 to C13 level measured in a blood sample from a patient diagnosed with nephritic autoimmune syndrome type 3 to identify the patient as a non-responder phenotype and administering to said patient the treatment. This has been considered but opt found persuasive. This example has no patient population having a responder phenotype as opposed to the non-responder phenotype which is being treated. Instant claim 27 is in line with example 23. Applicant argues that the combination of steps in claims 21 and 24 ensures that subjects who benefit from treatment are properly treated as opposed to being treated even if they had a low probability of responding favorable and that each of claims 21 and 24 when considered as a whole amount to significantly more than the alleged exception itself. This has been considered but not found persuasive. For the subject selected for treatment , the clams are significantly more than the exception itself. For the subjects not selected for treatment, the active method step of administering Osimertinib and the ADC does not apply.
The rejection of claims 22 and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments.
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.
Claims 21-27 and 30-33 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. This is a written description rejection
Claims 21, 24 and 27 have been amended to require that administration of osimertib and the anti-c-Met antibody drug conjugate achieves an objective response rate in the plurality of subjects that is greater than 30%. The specification teaches methods of treatment of non-squamous NSCLC that express c-Met in a plurality of human subject. When give the broadest reasonable interpretation, a plurality includes more than one subject. The specification fails to provide a written description of how many subjects constitute a “plurality” of subjects sufficient to provide the outcome of an objective response rate of greater than 30% within the plurality, such as 15, 20 or 30 patients. One of skill in the art would reasonably conclude that applicant was not in possession of the invention at the time of filing.
The rejection of claims 21, 23, 24, 26, 27, 30, 31, 33 under 35 U.S.C. 103 as being unpatentable over the abstract of Camidge e et al (Annals of Oncology, (September 2020) Vol. 31, Supp. Supplement 4, pp. S894, reference of the IDS filed 9/15/2023) as evidenced by Copeland and Younes (Drugs of the Future, 2010, Vol. 35, page 797), and Fotin-Mleczek et al (WO2017/186928), in view of Chen et al (Molecules 2017, Vol. 22, 28 pages), the abstract of Camidge et al (Cancer Res , 2021, Vol. 81, No. 13 Supplement, abstract no. CT179) and Wang et al (Clinical Cancer Research, 2017, Vol. 23, pp. 992-1000, reference of the IDS submitted 9/15/20);.
the rejection of claims 21, 23, 24, 26, 27, 30, 31, 33 under 35 U.S.C. 103 as being unpatentable over the abstract of Camidge (2020) et al, Copeland and Younes, Fotin-Mleczek et al, Wang et al, Chen et al and the abstract of Camidge et al (2021) as applied to claims 1, 4-6, 14-18, 20, 21, 23, 24, 26, 27-31, 33 above, and further in view of Strickler et al (journal of Clinical Oncology, 2018, Vol, 36, pp. 3298-3306, reference of the IDS filed 9/15/2023); and
the rejection of claims 1-6, 14-18, 20, 21, 23, 24, 26, 27-31, under 35 U.S.C. 103 as being unpatentable over the abstract of Camidge (2020) et al, Copeland and Younes, Fotin-Mleczek et al, Wang et al, Chen et al and the abstract of Camidge et al as applied to claims 1, 4-6, 14-18, 20, 21, 23, 24, 26, 27-31, 33 above, and further in view of Schmid et al (Lung Cancer, 2020, Vol. 147, pp. 123-129)
is withdrawn in light of applicant’s amendment incorporating the subject matter of prior claim 7 into claims 21, 24 and 27.
All claims are rejected.
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.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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