NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/KR2021/020112, filed Dec. 29, 2021, which claims benefit of foreign priority to Korean application 10-2020-0186819, filed Dec. 29, 2020.
Claims 1-11, as amended, are pending.
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
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 27, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,325,694 in view of Bhatt et al. (USPN 9,662,394) and Mahato et al. (Pharmaceutical Dosage Forms and Drug Delivery, 3rd Ed., Ch. 20: Tablets, pp. 479-508 (2018) (all cited on PTO-892).
Reference claims 1-5 are drawn to an oral or parenteral pharmaceutical composition comprising a co-crystallization product of efinaconazole and a pharmaceutically acceptable coformer forming a co-crystalline phase, wherein the coformer includes polyethylene glycol-6000, having a powder X-ray diffraction (XRD) spectrum with ten specific diffraction angle (2θ) peaks, and a differential scanning calorimetry (DSC) thermogram with two specific maximum endothermic peaks.
Reference claims 6-8 are drawn to methods for preparing a co-crystallization product of efinaconazole comprising dissolving efinaconazole and a pharmaceutically acceptable coformer in an organic solvent to prepare a mixed solution, and evaporating the mixed solution to remove the solvent, wherein the coformer includes polyethylene glycol; wherein the mixed solution is prepared with stirring or under heating; and wherein the organic solvent includes acetonitrile.
Thus, the reference claims recite pharmaceutical compositions for oral use comprising a co-crystallization product of efinaconazole and polyethylene glycol-6000, which is identical to the co-formed product of efinaconazole and polyethylene glycol recited by examined claim 1.
It is intrinsic that the weight ratio of efinaconazole to polyethylene glycol in the co-formed product is 1:1, as recited by examined claim 4.
The reference claims differ from the examined claims in that the reference claims do not explicitly recite that the pharmaceutical compositions comprise a pharmaceutically acceptable additive, as recited by examined claim 1.
However, one of ordinary skill in the art of would interpret the term "pharmaceutical composition" to necessarily imply the presence of one or more pharmaceutically acceptable additives, in addition to the active agent. Further, the reference patent discloses that the claimed pharmaceutical composition is formulated into general pharmaceutical preparations for oral or parenteral administration by suitable techniques known in the art (col. 5, lines 31-43).
For example, Bhatt et al. disclose and claim compositions comprising efinaconazole and pharmaceutically acceptable excipients, formulated as a solution (claim 1), as recited by examined claims 2 and 5.
Bhatt et al. exemplify efinaconazole compositions 34-39 as shown in Table 10, which are formulated as solutions and comprise, e.g., acrylates/C10-30 alkyl acrylate crosspolymer, as recited by examined claim 6; and propylene glycol, as recited by examined claim 7.
The compositions of Bhatt et al. can contain other components, such as preservatives, lubricants, humectants, moisture regulators, foaming agents, binders, pH regulators, osmotic pressure modifiers, emulsifiers, colors, aerosol propellants, fragrances, or odor maskers. Bhatt et al. disclose that those of skill in the art are aware of the components that are useful for a chosen formulation, which are described in sources such as Remington: The Science and Practice of Pharmacy, 20th ed., 2000 (col. 11, lines 46-57).
In addition, Mahato et al. describe excipients suitable for tablet formulations, including, e.g., croscarmellose sodium as a disintegrant, as recited by examined claim 8; and sodium stearyl fumarate as a lubricant, as recited by examined claim 9 (Table 20.4, p. 493).
Bhatt et al. disclose that efinaconazole has demonstrated activity in the treatment of the fungal infection onychomycosis (col. 1, lines 21-26), as recited by examined claims 10-11.
Finally, Bhatt et al. disclose that the amount of efinaconazole in the compositions ranges from about 8% (w/w) to about 12% (w/w), e.g., about 10% (w/w), or can range from about 0.5% (w/w) to about 5% (w/w), e.g., about 2% (w/w) (col. 1, lines 51-57).
Bhatt et al do not specify compositions comprising 0.6 to 2040 mg efinaconazole, as recited by examined claim 3. However, as recognized by MPEP § 2144.05,
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been predictable to an ordinarily skilled clinician as of the filing date to modify the efinaconazole amounts and dosages disclosed by Bhatt et al. to arrive at the compositions of the examined claims with a reasonable expectation of success, because adjusting drug dosages based on patient-specific variables are a routine aspect of the clinician's work. Further, "the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629