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 .
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.
Claim(s) 1-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US 9,682,973).
The claims are drawn to combination of pharmaceutical compositions for co-administration to prevent or treat cancer, wherein the combination comprises a first composition comprising a compound of formula 1 as an active ingredient, and a second composition comprising at least one anticancer drug. The claims are also drawn to a method of treating or preventing cancer by co-administering the combination of claim 1, and to a kit for the treatment of cancer comprising the combination of claim 1, wherein the first composition is to be administered simultaneously, separately, or sequentially.
Kang et al. teach phthalazinone derivatives and pharmaceutical compositions comprising the same, for treating cancers that may be caused by PARP activity or generic defect of BRCA1, BRCA2m and ERG fusion gene. Such cancers include breast cancer, ovarian cancer, pancreatic cancer, gastric cancer, lung cancer, and others (col. 29, lines 55-65). A specific phthalazinone derivative that may be used in the pharmaceutical composition is found at the top of column 28, or at the bottom of column 29 of the reference.
Kang et al. further teach that compounds of their invention may be combined in a pharmaceutical combination formulation, or dosing regimen as combination therapy, with a second compound having anticancer properties, or at least two kinds of pharmaceutical active ingredients. Examples of agents include, inter alia, oxaliplatin or irinotecan (anticancer drugs), rapamycin or sirolimus (T-cell therapeutics), sutent, e.g., SUNITINIB, SU11248 (angiogenesis inhibitor), anti-metabolites, such as methotrexate and 5-fluorouracil, antibiotics such as the enediyne antibiotics, androgens such as calusterone, anti-adrenals such as aminoglutethimide (hormone therapy).
The compounds taught by Kang et al. may be administered simultaneously, gradually, or individually with at least one of the therapeutic agents recited. The combined therapeutics may be administered orally or parenterally. The precise daily dose administered will depend on factors such as age, weight, sex, and condition of the patient being treated. For example, the compound of the invention may be administered in a range from 0.05 to 1000 mg daily (col. 30 line 1, to col. 31, line 67; col. 33, lines 1-64).
The difference between the present invention and the method taught by Kang et al. is that the instant claims teach a phthalazinone derivative that is not identical to the compounds taught by Kang et al. For example, the compound at the top of column 28 in Kang et al., having an aminocyclopropyl group, differs from the compound in the present invention, as the aminocyclopropyl group is attached to a four-membered nitrogen ring in the present invention, and a 5-membered nitrogen ring in Kang et al. The compound at the bottom of column 29 in the reference has a nitrogen-containing ring attached to an aminocyclobutyl, not an aminocyclopropyl as in the present invention.
The examiner does not find that this is a patentable distinction, as the generic structure of the phthalazinone derivative taught by Kang et al. encompasses the compound recited in the present invention, and the specific derivatives recited by Kang et al. are close enough to the compound of instant formula 1 that the activity of the instant compound would be reasonably expected to mimic the examples taught by Kang et al. in treating cancers.
The reference does not teach the specific dosages recited in the instant claims; however, as previously stated, precise daily dose administered will depend on factors such as age, weight, sex, and condition of the patient being treated.
The instant claims are deemed obvious over Kang et al.
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 1-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-8 and 10-13 of copending Application No. 18/566,503 in view of Kang et al. (US 9,682,973). Both sets of claims are drawn to a pharmaceutical composition for treating cancer comprising a compound of formula 1, the difference being that the instant claims include a second composition comprising at least one anticancer drug. However, Kang et al. teach phthalazinone derivatives and pharmaceutical compositions comprising the same, for treating cancers that may be caused by PARP activity or generic defect of BRCA1, BRCA2m and ERG fusion gene. Such cancers include breast cancer, ovarian cancer, pancreatic cancer, gastric cancer, lung cancer, and others (col. 29, lines 55-65). Specifically, Kang et al. teach that the phthalazinone derivatives may be combined in a pharmaceutical combination formulation, or dosing regimen as combination therapy, with a second compound having anticancer properties, or at least two kinds of pharmaceutical active ingredients. Examples of agents include, inter alia, oxaliplatin or irinotecan (anticancer drugs), rapamycin or sirolimus (T-cell therapeutics), sutent, e.g., SUNITINIB, SU11248 (angiogenesis inhibitor), anti-metabolites, such as methotrexate and 5-fluorouracil, antibiotics such as the enediyne antibiotics, androgens such as calusterone, anti-adrenals such as aminoglutethimide (hormone therapy).
The compounds taught by Kang et al. may be administered simultaneously, gradually, or individually with at least one of the therapeutic agents recited. The combined therapeutics may be administered orally or parenterally. The precise daily dose administered will depend on factors such as age, weight, sex, and condition of the patient being treated. For example, the compound of the invention may be administered in a range from 0.05 to 1000 mg daily (col. 30 line 1, to col. 31, line 67; col. 33, lines 1-64).
The instant claims are rendered obvious by the claims of the ‘503 application, in view of Kang et al., since the reference application teaches the same phthalazinone compound as recited in the instant claims, in a composition for treating cancer, and Kang et al. teaches that such phthalazinone derivatives may be used with other anticancer agents in a combination of pharmaceutical compositions.
This is a provisional nonstatutory double patenting rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIKARL A WITHERSPOON whose telephone number is (571)272-0649. The examiner can normally be reached M-F 9am-9pm IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692
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