DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 08/14/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103 - Obviousness
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) 28-29, 31-35, 36, 37-39 and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Olschewski et al (US 2008/0200449 A1), in view of Crowder et al (US 2004/0025877 A1) and further in view of Cossi et al (US 2007/0215151 A1).
Olschewski taught kits for administering treprostinil [abstract] to a subject in need thereof [0009; patient taught at [0013]], comprising inhalable drug particles of treprostinil administered, by a metered dose inhaler, at from about 15 μg to about 100 μg [0044], where the metered dose inhaler was a dry powder inhaler [claim 3].
Olschewski did not teach a plurality of dosage units; a body configured to receive a dosage unit; or, a mouthpiece; a monodose dry powder inhaler, each as recited by claim 28.
Crowder taught a dry powder inhaler [claim 32], and a multi-dose dry powder package for holding pharmaceutical grade formulations of inhalable dry powder substances (e.g., reads on a plurality of dosage units; see also ¶ 0017), comprising a platform body comprising a plurality of sealed blisters thereon (e.g., reads on a body configured to receive a dosage unit) [claim 1]. The blister packages allowed for the fabrication of a plurality of disposable, discrete meted doses [claims 32 and 62; ¶ 0114-0116, 0135].
The inhalation port of the dry powder inhaler was formed in a mouthpiece, comprising an activation button, that when depressed (e.g., into a desired closed and/or open position), initiated the active dispensing of the dry powder substance located in the inhalation output or dispensing region of the device. Crowder taught that the mouthpiece was configured to rotate so that serially overlayed each filled blister for inhalation (e.g., reads on wherein the dosage unit is opened when received by the body to allow delivery of the inhalable drug particles to the patient through the mouthpiece via inhalation) [0075-0076; see also ¶ 0115].
Since Olschewski taught a dry powder inhaler, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Olschewski, blister packs and a mouthpiece, as taught by Crowder. The ordinarily skilled artisan would have been motivated to allow for the fabrication of a plurality of disposable, discrete meted doses, further limited by a mouthpiece rotated to serially overlie each filled blister, for inhalation, as taught by Crowder [claims 32 and 62; ¶ 0114-0116, 0135].
Olschewski, in view of Crowder, did not teach a monodose dry powder inhaler.
Cossi taught monodose inhalers for powdered medicaments [title]. Specifically, Crossi taught a monodose inhaler for powdered medicaments that consisted of a hollow substantially pipe-shaped body that had a first portion (H), for housing a capsule or cartridge of powdered medicament, defined by a wall (W) in which there were formed slots (S) as air intakes to an inner region where the powder dropped, and a second portion (M) connected to the first portion (H) for delivering the medicament by means of a primary stream (F) that carried the powder from the drop region along a delivery duct (D) whose end was suitable to be placed in the patient's mouth.
It further included a secondary duct (D′) located under the delivery duct (D) and was provided with its own air intake (S′) for delivering a powderless secondary stream (F′). This stream (F′) supported and directed the primary stream (F) so that it climbed over the patient's tongue, thus preventing excessive deposition of the medicament in the oropharingeal cavity, while obtaining a greater effectiveness of the treatment, thanks to a larger amount of medicament that reached the lungs. Additionally, the monodose dry powder inhaler had a low cost, thanks to the fact that it was manufactured in plastic, by injection molding with a monolithic structure, and therefore could be used as a disposable inhaler [abstract].
Since Olschewski taught a dry powder inhaler, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Olschewski, a monodose dry powder inhaler, as taught by Crossi. The ordinarily skilled artisan would have been motivated to prevent excessive deposition of the medicament in the oropharingeal cavity, while obtaining a greater effectiveness of the treatment, thanks to a larger amount of medicament reaching the lungs. Additionally, the ordinarily skilled artisan would be motivated to include, within Olschewski, a monodose dry powder inhaler, because said inhalers can be manufactured in plastic with a monolithic structure, and therefore can be used as a disposable, as taught by Crossi at the abstract.
Olschewski, in view of Crowder and Crossi, reads on claims 28-29, 33, 31 and 43.
The instant claim 28 recites about 15 to about 110 micrograms treprostinil.
Olschewski taught about 15 μg to about 100 μg treprostinil. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim 34 is rendered prima facie obvious because Crowder taught that capsules are well known in the art [0004]. The motivation to combine Crowder with Olschewski was previously described.
Claim 35 is rendered prima facie obvious because Olschewski taught a mass median aerodynamic diameter of Treprostinil of 4-5 μm [0057].
The instant claim 35 recites a mass median aerodynamic diameter between 1 and 5 μm.
Olschewski taught a mass median aerodynamic diameter of treprostinil of 4-5 μm. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 36 is rendered prima facie obvious because Olschewski taught that the diameter of the treprostinil-containing aerosol particles are less than about 4 microns [0042].
Claim 37 is rendered prima facie obvious because Olschewski taught excipients [0042].
Claims 38-39 and 41are rendered prima face obvious because Crowder taught trehalose [0064]. The motivation to combine Crowder with Olschewski was previously discussed.
Claim 42 is rendered prima facie obvious because Olschewski taught aerosol production in two seconds [0074].
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Olschewski et al (US 2008/0200449 A1), in view of Crowder et al (US 2004/0025877 A1), further in view of Cossi et al (US 2007/0215151 A1) and further in view of Flöther et al (WO 96/07601).
The 35 U.S.C. 103 rejection over Olschewski, Crowder and Cossi was previously discussed.
Although the combined teachings of Olschewski, Crowder and Cossi taught blister packs, the combined teachings of the art did not teach a desiccant, as recited in claim 30
Flöther taught blister packages with desiccants [title], whereby desiccants provide packages for the dry storage of pharmaceutical preparations [page 2, lines 1-10; page 4, lines 9-12].
Since the combined teachings of Olschewski and Crowder taught blister packs, it would have been prima facie obvious to include, within the combined teachings of the art, blister packs including a desiccant, as taught by Flöther. The ordinarily skilled artisan would have been motivated to provide dry storage of pharmaceutical preparations, as taught by Flöther [page 2, lines 1-10; page 4, lines 9-12].
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Olschewski et al (US 2008/0200449 A1), in view of Crowder et al (US 2004/0025877 A1), further in view of Cossi et al (US 2007/0215151 A1) and further in view of Malinin et al (US 2015/0328232 A1).
The 35 U.S.C. 103 rejection over Olschewski, in view of Crowder and Cossi, was previously discussed.
Although Olschewski generally taught excipients, as previously discussed, the combined teachings of the art did not teach a wetting agent, as recited in claim 40.
Malinin taught prostacyclin compositions comprising a surfactant, at the abstract and title. In one embodiment, the composition comprised treprostinil in dry powder form, delivered to a patient in need thereof, via an inhalation device, e.g., a dry powder inhaler [0024]. The surfactant (e.g., wetting agent) was taught as an excipient [0101].
Since Olschewski generally taught excipients, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of the art, a surfactant, as taught by Malinin. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select a surfactant for incorporation into a composition, based on its recognized suitability for its intended use as an excipient, as taught by Malinin [0101].
Nonstatutory Double Patenting
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 28-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,357,782, in view of Olschewski et al (US 2008/0200449 A1), further in view of Crowder et al (US 2004/0025877 A1) and further in view of Cossi et al (US 2007/0215151 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are further limited to kits, comprising a body configured to receive a dosage unit, and further comprising a mouthpiece, wherein the dosage unit opens when received by the body, to allow delivery of the inhalable drug particle, through the mouthpiece, via inhalation. Additionally, the instant claims are further limited to a monodose dry powder inhaler. These limitations are not required of the issued claims.
Olschewski taught kits for administering treprostinil to a subject in need thereof.
Crowder taught a dry powder inhaler, and a multi-dose dry powder package for holding pharmaceutical grade formulations of inhalable dry powder substances, comprising a platform body comprising a plurality of sealed blisters thereon. The blister packages allowed for the fabrication of a plurality of disposable, discrete meted doses.
The inhalation port of the dry powder inhaler was formed in a mouthpiece, comprising an activation button, that when depressed, initiated the active dispensing of the dry powder substance located in the inhalation output or dispensing region of the device. Crowder taught that the mouthpiece was configured to rotate so that serially overlayed each filled blister for inhalation.
Cossi taught monodose inhalers for powdered medicaments [title]. They prevented excessive deposition of the medicament in the oropharingeal cavity, while obtaining a greater effectiveness of the treatment, thanks to a larger amount of medicament that reached the lungs. Additionally, the monodose dry powder inhaler had a low cost, thanks to the fact that it was manufactured in plastic by injection molding with a monolithic structure, and therefore could be used as a disposable inhaler [abstract].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, kits, a body configured to receive a dosage unit, and a mouthpiece, as taught by Olschewski and Crowder. The ordinarily skilled artisan would have been motivated to deliver the inhalable drug particles, as taught by Olschewski and Crowder.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, a monodose dry powder inhaler, as taught by Crossi. The ordinarily skilled artisan would have been motivated to prevent excessive deposition of the medicament in the oropharingeal cavity, while obtaining a greater effectiveness of the treatment, thanks to a larger amount of medicament reaching the lungs. Additionally, the ordinarily skilled artisan would be motivated to include, within the issued claims, a monodose dry powder inhaler, because said inhalers can be manufactured in plastic with a monolithic structure, and therefore can be used as a disposable, as taught by Crossi at the abstract.
Claims 28-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 9, 11 and 16-17 of copending Application No. 17/745,333 in view of Olschewski et al (US 2008/0200449 A1), further in view of Crowder et al (US 2004/0025877 A1) and further in view of Cossi et al (US 2007/0215151 A1).
Claims 28-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-20 of copending Application No. 17/967,255 in view of Olschewski et al (US 2008/0200449 A1), further in view of Crowder et al (US 2004/0025877 A1) and further in view of Cossi et al (US 2007/0215151 A1).
Claims 28-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/559,395 in view of Olschewski et al (US 2008/0200449 A1) and further in view of Crowder et al (US 2004/0025877 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are further limited to kits, comprising a body configured to receive a dosage unit, and further comprising a mouthpiece, wherein the dosage unit opens when received by the body, to allow delivery of the inhalable drug particle, through the mouthpiece, via inhalation. Additionally, the instant claims are further limited to a monodose dry powder inhaler. These limitations are not recited by the copending claims.
Olschewski taught kits for administering treprostinil to a subject in need thereof.
Crowder taught a dry powder inhaler, and a multi-dose dry powder package for holding pharmaceutical grade formulations of inhalable dry powder substances, comprising a platform body comprising a plurality of sealed blisters thereon. The blister packages allowed for the fabrication of a plurality of disposable, discrete meted doses.
The inhalation port of the dry powder inhaler was formed in a mouthpiece, comprising an activation button, that when depressed, initiated the active dispensing of the dry powder substance located in the inhalation output or dispensing region of the device. Crowder taught that the mouthpiece was configured to rotate so that serially overlayed each filled blister for inhalation.
Cossi taught monodose inhalers for powdered medicaments [title]. They prevented excessive deposition of the medicament in the oropharingeal cavity, while obtaining a greater effectiveness of the treatment, thanks to a larger amount of medicament that reached the lungs. Additionally, the monodose dry powder inhaler had a low cost, thanks to the fact that it was manufactured in plastic by injection molding with a monolithic structure, and therefore can be used as a disposable inhaler [abstract].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the copending claims, kits, a body configured to receive a dosage unit, and a mouthpiece, as taught by Olschewski and Crowder. The ordinarily skilled artisan would have been motivated to deliver the inhalable drug particles, as taught by Olschewski and Crowder.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, a monodose dry powder inhaler, as taught by Crossi. The ordinarily skilled artisan would have been motivated to prevent excessive deposition of the medicament in the oropharingeal cavity, while obtaining a greater effectiveness of the treatment, thanks to a larger amount of medicament reaching the lungs. Additionally, the ordinarily skilled artisan would be motivated to include, within the issued claims, a monodose dry powder inhaler, because said inhalers can be manufactured in plastic with a monolithic structure, and therefore can be used as a disposable, as taught by Crossi at the abstract.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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