DETAILED ACTION
Claims 13-21 are currently pending in the instant application.
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 .
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 07/17/2024 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
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Claim Objections
Claim 13 is objected to because of the following informalities: it has a structure for the named compound but it appears all the N and F atoms are distorted and out of place . Appropriate correction is required.
Claim 14 does not end in in a period. See MPEP 608.01(m) - Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). Appropriate correction is required. Examiner suggests including one or more limitations about what crystalline form A requires, followed by a period.
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.
Rejection I
Claims 13-14 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,131,663 (hereafter referred to as ‘663) in view of Shekunov et al (see Journal of Crystal Growth, 2000, Vol. 211, p. 122-136).
US Pat. No. ‘663 teaches the same compound
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in pharmaceutical compositions (see claims 2, 4 and 6) as found in the instant claims. Further the compound is taught for use in treating breast cancer (see col. 63 of ‘663). The instant method of use claim (claim 21) utilizes the same compounds taught by ‘663. According to In Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. court, “[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, ... and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted … .”
Although the claims of ‘663 do not teach a crystalline form, Shekunov et al teach that crystallization is a major technological process for particle formulation in pharmaceutical industry and plays an important role in defining stability and drug release properties of the final dosage forms. Crystalline forms of compounds are taught to have greater physical and chemical stability see Table 1). Thus it would be obvious to one of ordinary skill in the art to manufacture a crystalline form of the claimed compound using methods taught by Shekunov et al in order to find a more stable form of the compound since the claimed compound is taught to have use in treating cancer.
Rejection II
Claims 13-14 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,961,241 (hereafter referred to as ‘241) in view of Shekunov et al (see Journal of Crystal Growth, 2000, Vol. 211, p. 122-136).
US Pat. No. ‘241 teaches methods treating cancer, including breast cancer (see claims 2, 4 and 6) of using the same compound
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as the compound found in the instant claims. Further treatment may include administering a composition (see claim 7) and it would be obvious to add a carrier to an obvious compound – see Ex parte Douros, 163 USPQ 667 (P.T.O. Bd. App. 1968) in order to allow for administration of the compound in the treatment of disease (i.e. cancer).
Although the claims of ‘241 do not teach a crystalline form of said compound, Shekunov et al teach that crystallization is a major technological process for particle formulation in pharmaceutical industry and plays an important role in defining stability and drug release properties of the final dosage forms. Crystalline forms of compounds are taught to have greater physical and chemical stability see Table 1). Thus it would be obvious to one of ordinary skill in the art to manufacture a crystalline form of the claimed compound using methods taught by Shekunov et al in order to find a more stable form of the compound as the claimed compound is taught to have use in treating cancer.
Allowable Subject Matter
Claims 15-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
Prosecution Insights