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 .
Election/Restrictions
Applicant’s election without traverse of Group (I) with the addition of undifferentiated acute myeloid leukemia in the reply filed on 11/12/2025 is acknowledged.
Claims 5-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim.
Priority
This application is a continuation of U.S. Application No. 16/926,035, filed July 10, 2020, which is a continuation of U.S. Application No. 16/228,308, filed December 20 2018, which is a continuation of U.S. Application No. 15/713,385, filed September 22, 2017; which is a continuation of U.S. Application No. 15/201,286, filed July 1, 2016; which is a divisional of U.S. Application No. 14/213,784, filed on March 14, 2014; which claims priority to provisional U.S. Application No. 61/861,374, filed on August 1, 2013, provisional U.S. Application 61/911,354, filed on December 3, 2013, provisional U.S. Application No. 61/949,795, filed on March 7, 2014, and provisional U.S. Application No. 61/798,772, filed March 15, 2013.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/12/2025 has been considered by the examiner.
Status of Claims
Claims 1-14 are pending. Claims 5-14 are withdrawn. Claims 1-4 are examined in accordance to the elected species.
A reasonable and comprehensive search for the elected species conducted by the Examiner determined that the prior art at the time of the present invention was such that it did not anticipate or render obvious the elected species. In another word, the elected species is free of the art, but not allowable. Following election, the Markush-type claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. If the Markush-type claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush-type claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. On the other hand, should the examiner determine that the elected species is allowable, the examination of the Markush-type claims will be extended. If prior art is then found that anticipates or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the non-elected species held withdrawn from further consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 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. Claim 1 recites a method of treating AML in a human in need thereof comprising administering to the host… It is not clear if the host is the recited human or an animal that is not a human.
Claim 1 recites the limitation "host" in the second line. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation host, and the claim also recites human which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 8,598,186B2; claim 1 of U.S. Patent No. 10,189,850B2; claim 1 of U.S. Patent No. 10,189,849B2; claims 1-3 of U.S. Patent No. 10,927,120B2 in view of Fathi et al (Curr Oncol Rep. 2009 Sep;11(5):346–352). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of all the U.S. patent are drawn to
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. This compound is the same as the compound claimed. However, it is noted that the claims of the U.S. patents do not recite any utility. The specification of these patents discloses the utility of the recited compounds as covered by the instant methods of using the compounds as being cyclin dependent kinase activity, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound utility.
Fathi teaches a burgeoning area of drug development and investigation in the treatment of AML involves therapies that interfere with cell survival, cycling, and proliferation. The cell cycle is a tightly regulated process mediated by a variety of proteins, including cyclins, cyclin dependent kinases (CDKs), and CDK inhibitors. (See second paragraph of page 2.) Moreover, Fathi teaches Flavopiridol is a semisynthetic flavone derived from the stem bark of Amoora rohituka and Dysoxylum binectariferum, plants used in India as herbal medicines [5]. It is the first extensively studied CDK inhibitor and has been investigated in a variety of malignancies, including AML. It displays strong activity against several CDKs, including CDK1, CDK2, CDK4, CDK6, and CDK7; arrests the cell cycle at the G2/M phase; and delays the G1 to S phase progression. (See the third paragraph of page 2.) It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use the compound of the U.S. patent claims which is the same compound as the instant claims for treating AML that encompasses undifferentiated AML. One would be motivated to so, not only because the disclosure of the U.S. patent claims teaches that the compound exhibits CDK activity as permitted by Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co., but also because CDK activity is a target for AML and CDK inhibitors are effective in AML cells as taught by Fathi. One would reasonably expect the compound of the U.S. patent claims to successfully teach AML that includes undifferentiated AML.
Furthermore, it would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was filed to combine the compound disclosed by U.S. patent claims with a second CDK inhibitor, in this case Flavopriridol because each is taught by the prior art to be useful for the same purpose (i.e., treating AML that contemplates undifferentiated AML). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 8 of U.S. Patent No. 10,709,711 B2 in view of Tsukasaki et al (Cancer, Feb 1, 1998;82(3):488-94). Although the claims at issue are not identical, they are not patentably distinct from each other.
The U.S patent claims teach a method of treating T-cell lymphoma in a human in need thereof comprising administering to the host an effective amount of a compound having the structure:
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or a pharmaceutically acceptable salt thereof, wherein the compound, or its pharmaceutically acceptable salt thereof, is administered in combination therapy with a second and active agent. (See calms 7 and 8.)
The U.S. patent claims do not teach AML.
Tsukasaki teaches an association between adult T-cell leukemia/lymphoma (ATL) and acute myeloid leukemia (AML) has been reported only in four patients. (See Abstract.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use the method taught by the U.S. patent claims for treating AML. One would have been motived to do so, because Tsukasaki teaches an association between adult T-cell leukemia/lymphoma (ATL) and acute myeloid leukemia (AML) has been reported only in four patients. One would reasonably expect the method taught by the U.S. patent claims to be effective for treating AML in addition to ATL.
Conclusion
Claims 1-4 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628