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 2-7, 9, 10, 12, 13, 15-22, 24-56, 58-60, 62, 63, 65, 66, 68-75, 77-111, and 115 have been canceled. Claims 1, 8, 11, 14, 23, 57, 61, 64, 67, 76, 112-114, 116, and 117 have been amended. Claims 118122 have been added. Claims 1, 8, 11, 4, 23, 57, 61, 64, 67, 76, 112-114, 116-122 are pending and examined on the merits.
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.
Claim 117 is 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.
The recitation of TG02 lacks specific antecedent basis within the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 122 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 122 is dependent on claim 117 drawn to a kit comprising (16E)-14-Methyl-20-oxa-5,7,14,27 tetraazatetracyclo[19.3.1.12,6.18,12]heptacosa1(25),2,4,6(27),8,10,12(26),16,21,
23-decaene, also known as TG02, in combination with either of an immune checkpoint inhibitor or temozolomide, and instructions, for the intended use of administration to a patient having cancer. Claim 122 states that the type of cancer is hepatocellular, carcinoma, glioma, glioblastoma, lung, breast, head and neck, prostate, melanoma or colorectal. This fails to further limit the kit of claim 117 comprising TG02 and either of a immune checkpoint inhibitor or temozolomide, and instructions because the constituents of the kit remain the same regardless of the type of cancer being n the intended use.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 117 and 122 are rejected under 35 U.S.C. 103 as being unpatentable over NCT01204164 (version 16, April, 2015, reference of the IDS filed 10/04/2024) in view of Borch et al (Drug Discovery Today, 2015, Vol. 20, pp. 1127-1134)
NCT01204164 teaches the administration of TG02 for treatment of patients with hematological malignancies.
Borch et al teach that pidilizumab is used to treat advanced hematological malignancies and diffuse large cell B lymphoma (page 1130, Table 2).
It would have been prima facie obvious to provide a kit comprising pidilizumab and TG02. The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to produce a third composition that is to be used for the very same purpose since the idea of combining them flows logically from both compounds having been taught individually in the prior art. Applying the same logic to the instant claim 117 drawn to a kit, given the teaching of the prior art of using TG02 or treating patients with hematological malignancies, it would have been obvious to make a kit comprising the TG02 and pidilizumab for the convenience of the medical practitioner because the idea of combining the two agent would have logically followed from their having been individually taught in the prior art to be useful as agents for the treatment of hematological malignancies.
Claim 122 is included with this rejection, because reciting the cancer types as the intended use for the kit does not change the constituents of the kit.
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, 23, 57, 76, 112, 113, 114, 116-122 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,865,116 in view of the abstract of Naskhletashvili et al (Neuro-Oncology, September 2010, vol, 12, suppl. 3, pp. iii57-iii58, Abstract No. p148).
Claims 1-8 of the patent teach the limitations of claims 1, 23, 57, 76, 112, 113, 114, 116, 118-121 with the exception of (i)the citrate salt of 16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene required in instant claims 116 and 121, (ii)the kit of claims 117 and 122 and (iii)the requirement for temozolomide to be administered to the patient having cancer in addition to the (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene.
Regarding (i)the requirement for the citrate salt, section 804 IIb of the M.P.E.P states that
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).
In the instant case, the specification defines (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene as TG02, and states:
TG02 refers to the free base of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene. In another embodiment, TG02 refers to a pharmaceutically acceptable salt of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene, and i
n another embodiment TG02 refers to the citrate salt of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene.
Thus, the citrate salt of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene. In claims 116 and 121 is obvious over the claims of the patent directed to (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene.
Regarding the administration of (iii)temozolomide, the abstract of Naslkhletashvili et al teaches the administration of temozolomide, TMZ, to patients with non-small-cell lung cancer, breast cancer or melanoma brain metastases (title). The abstract teaches the combination of TMZ with whole brain irradiation
It would have been prima facie obvious to add temezolomide to patients with cancer being treated with TG02. . The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to produce a third composition that is to be used for the very same purpose since the idea of combining them flows logically from both compounds having been taught individually in the prior art. Applying the same logic to the instant method claims, given the teaching of the prior art of using temozolomide for treating patients with cancer, it would have been obvious to use the TG02 and temozolomide together for the treatment of cancer because the idea of doing so would have logically followed from their having been individually taught in the prior art to be useful as agents for the treatment of cancer patients.
Regarding (ii) the kit of claims 117 and 122, it would have been obvious to provide both the temezolomide and the TG02 together in a kit with instructions for the convenience of the medical practitioner for the same reasons as stated above.
Claims 1, 8, 11, 14, 57, 61, 64, 67, 112-114, 116-122 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,865,116 in view of Pardoll (Nature Reviews Cancer, 2012, vol. 12, pp. 252-264).
Claims 1-8 of the patent teach the limitations of claims 1, 23, 57, 76, 112, 113, 114, 116, 118-121 with the exception of (i)the citrate salt of 16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene required in instant claims 116 and 121, (ii)the kit of claims 117 and 122 and (iii)the requirement for a checkpoint inhibitor, such as a PD-1, PD-L1, CTLA-4, LAG3 or TIM3 inhibitor to be admisnintered to the patient having cancer in addition to the (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene.
Regarding (i)the requirement for the citrate salt, section 804 IIb of the M.P.E.P states that
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).
In the instant case, the specification defines (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene as TG02, and states:
TG02 refers to the free base of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene. In another embodiment, TG02 refers to a pharmaceutically acceptable salt of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene, and i
n another embodiment TG02 refers to the citrate salt of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene.
Thus, the citrate salt of (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene. In claims 116 and 121 is obvious over the claims of the patent directed to (16E)-14-methyl-20-oxa-5,7,14,26-tetraazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene.
Regarding the administration of (iii)of the checkpoint inhibitors to CTLA4, PD1, PDL1, LAG3 and TIM3, Pardoll et al teach that these agents are used clinically to treat multiple cancers (page 255, Table 1).
It would have been prima facie obvious to administer CTLA4, PD1, PDL1, LAG3 and TIM3 inhibitors, such as ipilimumab, MDX-1106, also known as nivolumab, MK3475, also known as pembrolizumab, CT-011, also known as pidilizumab, to patients with cancer being treated with TG02. The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to produce a third composition that is to be used for the very same purpose since the idea of combining them flows logically from both compounds having been taught individually in the prior art. Applying the same logic to the instant method claims, given the teaching of the prior art of using the checkpoint inhibitors for treating patients with cancer, it would have been obvious to use the TG02 and the checkpoint inhibitors together for the treatment of cancer because the idea of doing so would have logically followed from their having been individually taught in the prior art to be useful as agents for the treatment of cancer patients.
Regarding (ii) the kit of claims 117 and 122, it would have been obvious to provide both the checkpoint inhibitors and the TG02 together in a kit with instructions for the convenience of the medical practioner for the same reasons as stated above.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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