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 1-5 are pending in this application.
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.
Claims 3 and 5 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In evaluating the enablement question, several factors are to be considered. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The nature of the instant invention has claims, which embrace substituted [1,2,4]triazolo[4,3-c]pyrimidine compounds.
HOW TO USE: Claims 3 and 5 are drawn to the method of treatment of a disease or condition which is associated with EED and/or PRC2 inhibition. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The scope of claims 3 and 5 includes diseases and/or conditions not even known at this time, which may be associated with EED and/or PRC2 inhibitory activity. While the treatment of breast cancer has been linked with EED and/or PRC2 inhibitors the art does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced. “Cancer” cannot be deemed enabled. The notion that a compound could be effective against cancer in general is contrary to our current understanding of how pharmacologicals work. All attempts to find a pharmaceutical to treat cancer, etc. generally have thus failed.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others. The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
The claims include the treatment of cancer. Evidence involving a single compound and two types of cancer was not found sufficient to establish the enablement of claims directed to a method of treating seven types of cancer with members of a class of several compounds In re Buting 163 USPQ 689. The remarkable advances in chemotherapy have seen the development of specific compounds to treat specific types of cancer. The great diversity of diseases falling within the “tumor” category means that it is contrary to medical understanding that any agent (let alone a genus of thousands of compounds) could be generally effective against such diseases. The intractability of these disorders is clear evidence that the skill level in this art is low relative to the difficulty of the task.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
Claims 1-5 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 anastrozole, bicalutamide, bleomycin sulfate, busulfan, busulfan injection, capecitabine, N4-pentoxycarbonyl-5-deoxy-5-fluorocytidine, carboplatin, carmustine, chlorambucil, cisplatin, cladribine, cyclophosphamide, cytarabine, cytosine arabinoside, cytarabine liposome injection, dacarbazine, dactinomycin, daunorubicin hydrochloride, daunorubicin citrate liposome injection, dexamethasone, docetaxel, doxorubicin hydrochloride, etoposide, fludarabine phosphate, 5-fluorouracil, flutamide, tezacitibine, Gemcitabine, hydroxyurea, Idarubicin, ifosfamide, irinotecan, L-asparaginase, leucovorin calcium, melphalan, 6-mercaptopurine, methotrexate, mitoxantrone, mylotarg, paclitaxel, nab-paclitaxel, phoenix, pentostatin, polifeprosan 20 with carmustine implant, tamoxifen citrate, teniposide, 6-thioguanine, thiotepa, tirapazamine, topotecan hydrochloride for injection, vinblastine, vincristine, and vinorelbine, does not reasonably provide enablement for anti-cancer agent, an immunomodulator, an anti-allergic agent, an anti-emetic, a pain reliever or a cytoprotective agent, generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The nature of the instant invention has claims which embrace N-((5-fluoro-2,3-dihydrobenzofuran-4-yl)methyl)-8-(2-methylpyridin-3-yl)-[1,2,4]triazolo[4,3-c]pyrimidin-5-amine compounds.
The method of the instant invention where the N-((5-fluoro-2,3-dihydrobenzofuran-4-yl)methyl)-8-(2-methylpyridin-3-yl)-[1,2,4]triazolo[4,3-c]pyrimidin-5-amine compound is co-administered with an additional active ingredient that is an anti-cancer agent, an immunomodulator, an anti-allergic agent, an anti-emetic, a pain reliever or a cytoprotective agent. The specification does not define that which is intended in the use of an “anti-cancer agent”, “an immunomodulator”, “an anti-allergic agent”, “an anti-emetic”, “a pain reliever” or a cytoprotective agent”. The following is a list of anti-cancer agents, i.e. 5-fu, 6-mp, 6-tg, abarelix, alemtuzumab, alitretinoin, allopurinol, altretamine, amifostine, anakinra, arsenic trioxide, asparaginase, atra, azacitidine, bevacizumab, bexarotene, bortezomib, calusterone, carboplatin, ccnu, celecoxib, cetuximab, clofarabine, dalteparin, darbepoetin alfa, dasatinib, decitabine, denileukin, diftitox, dexrazoxane, dromostanolone propionate, eculizumab, elliott’s b solution, epoetin alfa, erlotinib, exemestane, fentanyl citrate, fulvestrant, gefitinib, gemtuzumab ozogamicin, goserelin, histrelin, ibritumomab, imatinib mesylate, iressa, lapatinib, lapatinib ditosylate, lenalidomide, letrozole, l-pam, mesna, methoxsalen, mithramycin, mitotane, nandrolone, phenpropionate, nelarabine, nitrogen mustard, nofetumomab, oprelvekin, palifermin, pamidronate, panitumumab, pegademase, pegaspargase, pegfilgrastim, peginterferon alfa-2b, pemetresed disodium, pipbroman, plicamycin, porfimer sodium, procarbazine, rasburicase, sorafenib, sunitinib, talc, tamoxifen, temozolomide, testolactone, thalidomide, tiuxetan, toremifene, tositumomab, trastuzumab, uracil mustard, valrubicin, vm-26, vorinostat, zoledronate, zoledronic acid, etc., which includes anti-cancer agents which are neither supported nor contemplated. This is just a few anti-cancer agents embraced by “anti-cancer agents”.
The method of the instant invention where the N-((5-fluoro-2,3-dihydrobenzofuran-4-yl)methyl)-8-(2-methylpyridin-3-yl)-[1,2,4]triazolo[4,3-c]pyrimidin-5-amine compound is co-administered with an additional active ingredient that is an immunomodulator. The specification does not define that which is intended in the use of an “immunomodulator”. The following is a list of immunomodulators, i.e. caffeic acid phenethylester, thalidomide, teriflunomide, amlexanox, ipilimumab, bexmarilimab, carotuximab, anti-complement C5aR1, ossirene, iberdomide, hydroxychloroquine, avadomide, ponesimod, laquinimod, fontolizumab, foralumab, anti-GD2, gefurulimab, talquetamab, Y-320, dehydrocostus lactone, LL37, VGX-1027. Benzyl isothiocyanate, lentinan, saikosaponin A, curculigoside, Ngm707, tebotelimab, etc., which includes immunomodulators which are neither supported nor contemplated.
In addition to the following anti-cancer agents and immunomodulators the claims include a cyclin-dependent kinase (CDK) inhibitor, a checkpoint kinase (CHK) inhibitor, a protein kinase B (PKB) inhibitor, an AKT inhibitor, a C-RAF Inhibitor, a phosphoinositide 3-kinase (PI3K) inhibitor, BCL-2 inhibitor, a mitogen-activated protein kinase (MEK) inhibitor, an aromatase inhibitor, a SRC inhibitor, a histone deacetylase (HDAC) inhibitor, an anti- tumor antibiotic, a demethylating agent, or an anti-estrogen.
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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,580,437. Although the claims at issue are not identical, they are not patentably distinct from each other because the composition and method of use of the compound N-((5-fluoro-2,3-dihydrobenzofuran-4-yl)methyl)-8-(2-methylpyridin-3-yl)-[1,2,4]triazolo[4,3-c]pyrimidin-5-amine is embraced by the compounds, compositions and method of use of the compounds of Formula (I) which includes an additional therapeutic agent and a method of using the same.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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