DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claims 2-19 are pending and under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
Claims 2-6, 9-15, 18 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating glioblastomas, oligodendrogliomas and astrocytomas in a subject comprising: detecting the presence of the IDH2 mutations R172K and R172G mutations in a nucleic acid present in a sample obtained from the subject, does not reasonably provide enablement for a method of treating any mutant isocitrate dehydrogenase 2 (IDH2) enzyme-associated cancer in a subject comprising: detecting the presence of any isocitrate dehydrogenase 2 (IDH2) mutation in a nucleic acid present in a sample. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The claims are drawn to method of treating a mutant isocitrate dehydrogenase 2 (IDH2) enzyme-associated cancer in a subject comprising: detecting the presence of an isocitrate dehydrogenase 2 (IDH2) mutation in a nucleic acid present in a sample obtained from the subject; and administering to the subject an antibody that inhibits the activity of the mutant IDH2 enzyme.
The specification disclose that IDH2 mutations were found in oligodendrogliomas and astrocytomas (Example 5, Fig 7). The specification disclose that the R172 residue was mutated to R172K in three tumors, and R172G in two tumors (Id).
One cannot extrapolate the teaching of the specification to the enablement of the claims because the specification does not provide examples or guidance for treating any mutant isocitrate dehydrogenase 2 (IDH2) enzyme-associated cancer in a subject comprising detecting the presence of any isocitrate dehydrogenase 2 (IDH2) mutation in a nucleic acid present in a sample. The specification only demonstrates that IDH2 mutations were found in oligodendrogliomas and astrocytomas and that the R172 residue was mutated to R172K in three tumors, and R172G in two tumors (Id). There are no examples demonstrating that IDH2 mutations were found in other cancers besides oligodendrogliomas and astrocytomas and that any other IDH2 mutations were present in oligodendrogliomas and astrocytomas besides R172K and R172G. The specification does not provide a nexus between any other cancers besides oligodendrogliomas and astrocytomas and the presence of IDH2 mutations besides R172K and R172G.
MPEP 2164.03 states that
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention.
MPEP 2164.03 further states that
The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. …
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.
MPEP 2164.08(b) states that
The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic examples do not make the disclosure nonenabling).
Although, typically, inoperative embodiments are excluded by language in a claim (e.g., preamble), the scope of the claim may still not be enabled where undue experimentation is involved in determining those embodiments that are operable. A disclosure of a large number of operable embodiments and the identification of a single inoperative embodiment did not render a claim broader than the enabled scope because undue experimentation was not involved in determining those embodiments that were operable. In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ 214, 218 (CCPA 1976). However, claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative.
The claims are drawn to method of treating a mutant isocitrate dehydrogenase 2 (IDH2) enzyme-associated cancer in a subject comprising: detecting the presence of an isocitrate dehydrogenase 2 (IDH2) mutation in a nucleic acid present in a sample obtained from the subject; and administering to the subject an antibody that inhibits the activity of the mutant IDH2 enzyme, wherein the antibody inhibits the activity of the mutant IDH2 enzyme. However, the specification only demonstrates that IDH2 mutations were found in oligodendrogliomas and astrocytomas and that the R172 residue was mutated to R172K in three tumors, and R172G in two tumors (Id). There are no examples demonstrating that IDH2 mutations were found in other cancers besides oligodendrogliomas and astrocytomas and that any other IDH2 mutations were present in oligodendrogliomas and astrocytomas besides R172K and R172G. The specification does not provide a nexus between any other cancers besides oligodendrogliomas and astrocytomas and the presence of IDH2 mutations besides R172K and R172G. Given the disclosure of the specification and the teaching in the art that indicates the unpredictability of diagnosing and treating cancer, one skilled in the art could not predictably administer an anti-cancer agent to treat just any tumor based on the detection of any IDH2 mutation. One of skill in the art would not be able to identify which IDH2 mutation besides mutations at the R172 residue would be capable of being treated with an anti-cancer agent. As stated above, claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative
Therefore, in view of the breadth of the claims, lack of guidance in the specification, the absence of working examples, and the state of the art, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed.
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 2-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,837,064 Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 10,837,064 are drawn to a method of treating a mutant isocitrate dehydrogenase 2 (IDH2) enzyme-associated central nervous system cancer in a subject comprising: detecting the presence of an isocitrate dehydrogenase 2 (IDH2) mutation in a nucleic acid present in a sample obtained from the subject; wherein the IDH2 mutation is present in a mutant codon that corresponds to a wild type codon that encodes amino acid 172 in the wild type IDH2 polypeptide of SEQ ID NO: 131; wherein the mutant codon that includes the IDH2 mutation encodes an amino acid selected from the group consisting of: methionine (M), lysine (K), and glycine (G); and administering to the subject a chemotherapeutic agent to treat the cancer.
Summary
No claims allowed.
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/MARK HALVORSON/ Primary Examiner, Art Unit 1646