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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 48-63 and 66-70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (WO 2015/089105, disclosed by applicant).
Xu et al. disclose dry powder compositions comprising vardenafil, or pharmaceutically acceptable salts or esters there. The dry powder composition may include a carrier/excipient. The concentration of the active agent may be at lease about 2% by weight. Methods of aerosolizing the dry powder compositions and using them to treat various diseases (Abstract). Xu et al. disclose the dose of micronized vardenafil has a nominal dose of at least about 0.25 mg ([0095]). Xu et al. disclose the lactose may be a suitable powder base with a fine lactose of less than 7 micron at a concentration of 2 to 50% by weight of the total lactose composition; wherein lactose of different size fractions may be combined in a dry powder composition. Xu et al. disclose particles of lactose of about 60 to about 90 micron. Xu et al. disclose treating pulmonary hypertension (([0099]). Xu et al. disclose the average particle size ranges about 1-3 microns to be effective delivery to the area of the lungs needed ([0106]). Xu et al. disclose pulmonary delivery with higher aerosolization efficiencies about 70% FPF may allow less mouth and throat deposition upon aerosolization and inhalation by a subject ([0107]). Xu et al. disclose the inhaled dose required to attain efficacy in a human subject with pulmonary hypertension delivered via a high efficiency in haler device may be about 1/10th to 1/20th the oral dose ([0108]). Xu et al. disclose the composition is administered by air flow induced through the outlet channel to cause air and powder pharmaceutical composition to enter into the dispersion chamber from the inlet, and to cause the actuator to oscillate within the dispersion chamber to assist in dispersing the powder pharmaceutical composition from the outlet for delivery to a subject through the outlet ([0080]).
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 1-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19-24 and 28 of U.S. Patent No. 11, 491,161. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims read on a method of treating pulmonary arterial hypertension, comprising administering to a subject in need thereof an affective amount of a vasodilator, wherein the vasodilator is administered to the subject via inhalation pro re nata using a portable inhaler.
Claims 1-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 17 of U.S. Patent No. 11,491,160. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims read on a method of treating pulmonary arterial hypertension, comprising administering to a subject in need thereof an affective amount of a vasodilator, wherein the vasodilator is administered to the subject via inhalation pro re nata using a portable inhaler.
Conclusion
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/NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612
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