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 .
Status of the Claims
Claims 1-35 have been cancelled. Claims 36-51 are newly added. Accordingly, claims 36-51 are pending in the application and are currently under examination.
Information Disclosure Statement
The IDS’s dated 1/17/2025 and 2/10/2026 have been considered. Signed copies are enclosed herewith.
Specification
The disclosure is objected to because of the following informalities: the term “Treprostinil” is recited throughout the specification. The term should be lowercase except when at the beginning of a sentence. Appropriate correction is required.
Claim Objections
Claims 36, 38-44, 47-49 and 51 are objected to because of the following informalities: the term “Treprostinil” is recited throughout said claims. The term should be in lowercase form. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 36 and 38-44 are rejected under 35 U.S.C. 103 as being unpatentable over Voswinckel et al. (“Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension”, Pulmonary Pharmacology & Therapeutics 22 (2009) 50–56; hereafter as “Voswinckel”) in view of Parikh et al. (“Safety and Tolerability of High-dose Inhaled Treprostinil in Pulmonary Hypertension”, J Cardiovasc Pharmacol, 2016 Apr; 67(4):322-5; hereafter as “Parikh”).
The claimed invention is drawn to a method of treating or preventing pulmonary hypertension in a subject, the method comprising: i) administering to said subject a first liquid composition comprising treprostinil, or a pharmaceutically acceptable salt thereof in a first concentration of about 1 mg/mL to about 3 mg/mL in an aerosolized form for a first treatment period; and ii) administering to said subject a second liquid composition comprising treprostinil, or a pharmaceutically acceptable salt thereof in a second concentration of about 2 mg/mL to about 4 mg/mL in an aerosolized form for a second treatment period following the first treatment period, wherein the second concentration of treprostinil, or a pharmaceutically acceptable salt thereof in the second liquid composition is higher than the first concentration of treprostinil, or a pharmaceutically acceptable salt thereof in the first liquid composition, and wherein the first and second liquid compositions are aerosolized and administered to the subject using a single soft mist inhaler.
Regarding instant claim 36, Voswinckel teaches a method of treating pulmonary hypertension by administering treprostinil (TRE) via Respimat® metered dose inhaler which was filled with either a concentration of 1000 µg/ml (1 mg/ml) treprostinil sodium (15 µg TRE per puff) or with 2000 µg/ml (2 mg/ml) (30 µg TRE per puff) (abstract; page 51, section 2. Method and patients). Voswinckel teaches that the Respimat® device was chosen for this study because the implemented “soft mist” technology seemed to be well suited for the peripheral lung deposition of highly active drugs like prostanoids as it generates a rather slow stream of aerosol instead of a sharp pulse that may result in higher oral and pharyngeal deposition (page 51, right col., 1st para.).
Voswinckel is silent to administration of two different dosages of treprostinil, the second dosage being higher than the first dosage (i.e., titration). It is noted that the instant specification states, “The common therapy for pulmonal hypertension involves slowly increasing the dosage (the so called "titration" effect) of Treprostinil or a pharmaceutically acceptable salt or derivative thereof until Treprostinil or a pharmaceutically acceptable salt or derivative thereof is administered in a final maintenance dose, which is usually a third dosage, but may also be the second dosage” (page 13, lines3-7).
Parikh teaches administration of titrated treprostinil for the treatment of pulmonary hypertension (abstract). The dosing protocol included 3 breaths (18 µg)/initial session, 6 breaths (36 µg)/second session, and then titration as tolerated, based on side effects, by 1 breath daily until a maximum dosage of 12 breaths (72 µg) four times daily is achieved (page 323, left col., 1st para.; Fig. 1). Parikh also teaches that in a sick patient population with significant functional limitations and poor reserve, rapid titration of therapy to optimal dose (one that provides increased efficacy with tolerable side effects) is a critical part of management whenever possible (page 325, left col., 2nd paragraph).
Both Voswinckel and Parikh are both drawn to inhalation of treprostinil for the treatment of pulmonary hypertension, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a titrated dosing protocol in Voswinckel, as suggested by Parikh, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Parikh teaches that titration dosing is utilized to reach an optimal dose, i.e., one that provides increased efficacy with tolerable side effects, as a critical part of managing pulmonary hypertension.
Regarding instant claims 38 and 39, Voswinckel and Parikh teach the elements discussed above including dosage amounts that fall within the claimed ranges of about 10 µg to about 25 µg and about 15 µg to about 20 µg. Both Voswinckel and Parikh are both drawn to inhalation of treprostinil for the treatment of pulmonary hypertension, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of an initial dose by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel teaches doses of 15 µg and Parikh teaches an initial dose of 18 µg are effective doses/initial doses in the treatment of pulmonary hypertension. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (MPEP 2144.05(II)(A)).
Regarding instant claims 40 and 41, Voswinckel and Parikh teach the elements discussed above including dosage amounts that fall within the claimed ranges of about 25 µg to about 50 µg and about 30 µg to about 40 µg. Both Voswinckel and Parikh are both drawn to inhalation of treprostinil for the treatment of pulmonary hypertension, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of a subsequent dose by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel teaches doses of 30 µg and Parikh teaches subsequent doses of 36 to 72 µg as effective doses/subsequent doses in the treatment of pulmonary hypertension. “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(I)). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (MPEP 2144.05(II)(A)).
Regarding instant claim 42, Voswinckel and Parikh teach the elements discussed above. Voswinckel further teaches inhalation of an effective treprostinil dose in one single breath was achieved with highly concentrated treprostinil sodium solution of 2000 ug/ml (2 mg/ml) without side effects (page 54, right col.). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer in a single event during the first and second treatment period in one breath each upon a single activation of the soft mist inhaler upon with a single metered dose of treprostinil is dispensed in the invention of Voswinckel and Parikh with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel teaches that up to 2 mg/ml of treprostinil can be administered in a single breath effectively via a soft mist inhaler without any side effects for the treatment of pulmonary hypertension.
Regarding instant claims 43 and 44, Voswinckel and Parikh teach the elements discussed above including daily dosage amounts that fall within the claimed ranges of about 40 µg to about 100 µg and about 100 µg to about 200 µg (30 µg, 45 µg and 60 µg in Voswinckel and up to 288 µg (72 µg 4 times) in Parikh). Both Voswinckel and Parikh are both drawn to inhalation of treprostinil for the treatment of pulmonary hypertension, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of a first treatment daily dose and the second treatment daily dose by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel teaches daily doses of 30 µg, 45 µg and 60 µg and Parikh teaches daily doses of 18 µg, 36 µg, and up to 288 µg as effective daily doses in the treatment of pulmonary hypertension and it is not inventive to discover the optimum amounts within disclosed amounts of the prior art. “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(I)). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (MPEP 2144.05(II)(A)).
Thus, the combined teachings of Voswinckel and Parikh render the instant claims prima facie obvious.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Voswinckel et al. (“Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension”, Pulmonary Pharmacology & Therapeutics 22 (2009) 50–56; hereafter as “Voswinckel”) in view of Parikh et al. (“Safety and Tolerability of High-dose Inhaled Treprostinil in Pulmonary Hypertension”, J Cardiovasc Pharmacol, 2016 Apr; 67(4):322-5; hereafter as “Parikh”), as applied to claim 36 above, and further in view of Olschewski et al. (US 2008/0200449 A1, Aug. 21, 2008, hereafter as “Olschewski”).
The claimed invention is described above.
Voswinckel and Parikh teach the elements discussed above. Voswinckel further teaches that the treprostinil is in the form of a solution (page 54, right col.).
Voswinckel and Parikh are silent to the liquid compositions are an aqueous solution comprising an aqueous solvent to mixture of solvents.
Olschewski teaches administration of a pharmaceutical formulation comprising treprostinil via a metered dose inhaler (e.g., a soft mist inhaler) for the treatment of pulmonary hypertension (abstract; [0010]; claim 47). Olschewski also teaches that the pharmaceutical formulation comprises water, ethanol or a mixture thereof (claims 44, 47 and 48).
The references are all drawn to inhalation of treprostinil for the treatment of pulmonary hypertension, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the particular solvents, water and/or ethanol in the treprostinil solution of Voswinckel/Parikh, as suggested by Olschewski with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel generally teaches a treprostinil solution and Olschewski teaches a particular treprostinil solution comprising water and/or ethanol as suitable solvents in the administration of treprostinil via a soft mist inhaler for the treatment of pulmonary hypertension.
Thus, the combined teachings of Voswinckel, Parikh and Olschewski render the instant claim prima facie obvious.
Claims 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Voswinckel et al. (“Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension”, Pulmonary Pharmacology & Therapeutics 22 (2009) 50–56; hereafter as “Voswinckel”) in view of Parikh et al. (“Safety and Tolerability of High-dose Inhaled Treprostinil in Pulmonary Hypertension”, J Cardiovasc Pharmacol, 2016 Apr; 67(4):322-5; hereafter as “Parikh”), as applied to claim 36 above, and further in view of Knell et al. (BR 112016000367 B1, Dec. 28, 2021, machine translation, hereafter as “Knell”).
The claimed invention is described above.
Voswinckel and Parikh teach the elements discussed above.
Voswinckel and Parikh are silent to the soft mist inhaler is adapted to generate an aerosol or plume of aerosol of the first and second liquid composition with an average velocity of about 1.0 m/s to about 2.5 m/s or about 1.3 m/s to about 2.1 m/s.
Knell teaches a soft mist inhaler that produces an atomized sprinkler (aerosol) that is dispensed at a velocity of less than 2 m/sec, preferably approximately 1.6 m/sec or less, and especially preferably less than 1 m/sec (abstract; [0002]).
All of the references are generally drawn to methods of inhalation and Voswinckel and Knell are more particularly, drawn to inhalation via soft mist inhalers, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a soft mist inhaler adapted to generate an aerosol with a velocity of less than 2 m/sec in Voswinckel/Parikh, as suggested by Knell with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel generally teaches soft mist inhalers as suitable for administering treprostinil and Knell teaches velocities of less than 2 m/sec are suitable in dispensing an aerosol from a soft mist inhaler. It would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the velocity by way of routine experimentation with a reasonable expectation of success because it is not inventive to discover the optimum values within a disclosed set taught by the prior art. “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(I)). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (MPEP 2144.05(II)(A)).
Thus, the combined teachings of Voswinckel, Parikh and Knell render the instant claims prima facie obvious.
Claims 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Voswinckel et al. (“Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension”, Pulmonary Pharmacology & Therapeutics 22 (2009) 50–56; hereafter as “Voswinckel”) in view of Parikh et al. (“Safety and Tolerability of High-dose Inhaled Treprostinil in Pulmonary Hypertension”, J Cardiovasc Pharmacol, 2016 Apr; 67(4):322-5; hereafter as “Parikh”), as applied to claim 36 above, and further in view of Rawert et al. (WO 2021/198151 A1, Oct. 7, 2021, hereafter as “Rawert”).
The claimed invention is described above.
Voswinckel and Parikh teach the elements discussed above.
Regarding instant claim 47, Voswinckel and Parikh are silent to wherein the soft mist inhaler is adapted to hold the first and second liquid compositions comprising treprostinil, or a pharmaceutically acceptable salt thereof at atmospheric pressure.
Rawert teaches an inhalation device system for the inhalative administration of a medically active liquid in nebulized form (i.e., a soft mist inhaler), the system comprising an inhalation device and an exchangeable reservoir for holding the medically active liquid (i.e., adapted to hold the first and second liquid composition), wherein the inhalation device comprises - a housing having a receiving unit, the receiving unit having a connection unit adapted to releasably and fluidically connect to a connection port of the exchangeable reservoir, the receiving unit being adapted to receive and fluidically connect to the exchangeable reservoir; - a nozzle for nebulization of the medically active liquid; and - a pumping unit arranged within the housing and adapted to be fluidically connected to the reservoir (via the connection unit of the receiving unit) and to the nozzle and being adapted to convey (pressurize, pump) the medically active liquid in a downstream direction from the reservoir to the nozzle (abstract). Rawert also teaches that the inner container may have a non-flexible or rigid form wherein pressure equalization with the surrounding atmosphere during administration of the medically liquid stored therein is achieved by other means, such as inlet valves or a movable piston (page 21, lines 29-32).
All of the references are generally drawn to methods of inhalation and Voswinckel and Rawert are more particularly, drawn to inhalation via soft mist inhalers, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a soft mist inhaler having an exchangeable reservoir to hold the first and second liquid composition at atmospheric pressure in Voswinckel/Parikh, as suggested by Rawert with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel generally teaches soft mist inhalers as suitable for administering treprostinil and Rawert teaches a soft mist inhaler having an exchangeable reservoir that effectively allows for the active agent liquid compositions to be loaded and switched out for different active agents or dosages as well as a means for allowing pressure equalization with the surrounding atmosphere such as inlet valves or a movable piston.
Regarding instant claim 48, Voswinckel and Parikh are silent to wherein the soft mist inhaler comprises a pumping unit adapted to generate a working pressure of the first and second liquid composition comprising treprostinil, or a pharmaceutically acceptable salt thereof of about 50 to about 350 bar.
Rawert, as stated above, teaches that the inhalation device system for the inhalative administration of a medically active liquid in nebulized form (i.e., a soft mist inhaler) comprises a pumping unit arranged within the housing and adapted to be fluidically connected to the reservoir (via the connection unit of the receiving unit) and to the nozzle and being adapted to convey (pressurize, pump) the medically active liquid in a downstream direction from the reservoir to the nozzle (abstract). Rawert also teaches that the pumping unit is a high-pressure pumping unit and adapted to operate, or to expel fluid, at a pressure of at least about 50 bar, up to 1000 bar, preferably from about 50 bar to about 250 bar (page 12, lines 25-29).
All of the references are generally drawn to methods of inhalation and Voswinckel and Rawert are more particularly, drawn to inhalation via soft mist inhalers, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a soft mist inhaler having a pumping unit that generates pressures of about 50 to about 1000 bar, preferably about 50 bar to about 250 bar in Voswinckel/Parikh, as suggested by Rawert with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel generally teaches soft mist inhalers as suitable for administering treprostinil and Rawert teaches a soft mist inhaler having a pumping unit that generates pressures of about 50 to about 1000 bar, preferably about 50 bar to about 250 bar is suitable for the purpose of dispensing an active agent from a soft mist inhaler. “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).
Regarding instant claim 49, Voswinckel and Parikh are silent to an impingement-type soft mist inhaler having at least one nozzle with at least two ejection channels adapted to generate at least two jets of the first and second liquid composition comprising treprostinil, or a pharmaceutically acceptable salt thereof, which intersect to generate an aerosol.
Rawert teaches, in a particular embodiment, that the inhalation device comprising an impingement-type nozzle, said nozzle is adapted to emit at least two jets of liquid from fluid channels, the two jets of liquid are directed to collide and break up into small aerosol droplets (page 8, lines 26-34; page 17, lines 11-14).
All of the references are generally drawn to methods of inhalation and Voswinckel and Rawert are more particularly, drawn to inhalation via soft mist inhalers, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a soft mist inhaler having an impingement-type nozzle comprising at least one nozzle with at least two ejection channels adapted to generate at least two jets of liquid which intersect to generate an aerosol in Voswinckel/Parikh, as suggested by Rawert with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel generally teaches soft mist inhalers as suitable for administering treprostinil and Rawert teaches a soft mist inhaler having an impingement-type nozzle comprising at least one nozzle with at least two ejection channels that generate at least two jets of liquid which intersect to generate an aerosol suitable to administer aerosolized medication.
Regarding instant claim 50, Voswinckel and Parikh are silent to the soft mist inhaler having the characteristics of claim 50.
Rawert teaches the inhalation device system for the inhalative administration of a medically active liquid in nebulized form (i.e., a soft mist inhaler) described above (abstract). Rawert teaches that the device is a hand held device (page 7, lines 18-22). Rawert teaches that the inhalation device system comprises a housing, wherein the housing has a user-facing side (page 7, lines 28-34). Rawert teaches that the inhalation device system comprises an impingement-type nozzle wherein the nozzle is adapted to emit at least two jets of liquid which are directed such as to collide and break up into small aerosol droplets. In specific embodiments, the nozzle is firmly affixed to the housing, especially to the user-facing side of the housing of the inhalation device in such a way that it is immobile, or non-moveable, relative to the housing or at least relative to the side or part of the housing which faces the user (e.g., patient] or which, more specifically, is introduced to the mouth of a user when the device is used (paragraph bridging pages 8-9). Rawert also teaches that the inhalation device system comprises a fluid reservoir arranged within the housing (page 8, lines 18-25). Rawert teaches that the inhalation device system comprises a pumping unit that has an upstream end that is fluidically connected to the exchangeable reservoir and a downstream end that is fluidically connected to the nozzle, wherein the pumping unit pumps the medically active liquid from the reservoir to the nozzle (page 9, lines 4-11; page 10, lines 4-5). Rawert further teaches that the pumping unit has an upstream end that is fluidically connected to the exchangeable reservoir; a downstream end that is fluidically connected to the nozzle; wherein the pumping unit further comprises (i) a riser pipe having an upstream end, wherein the riser pipe is adapted to function as a piston in the pumping unit, and wherein the riser pipe is firmly affixed to the user-facing (downstream) side of the housing such as to be immobile relative to the housing; and (ii) a hollow cylinder located upstream of the riser pipe, wherein the upstream end of the riser pipe is inserted in the cylinder such that the cylinder is longitudinally movable on the riser pipe (page 34, lines 7-15). Rawert also teaches that the pumping unit may comprise a riser pipe which may be adapted to function as a piston in the pumping unit, a hollow cylinder and a lockable means for storing potential energy, wherein the lockable means may be capable of storing potential energy when locked and may be adapted for releasing the stored energy when unlocked(e.g., a spiral spring or other elastic element). The lockable means may be arranged outside of and mechanically coupled to the hollow cylinder in such a way that unlocking the means results in a propulsive longitudinal movement of the cylinder towards the downstream end of the pumping unit (page 10, lines 1-15).
All of the references are generally drawn to methods of inhalation and Voswinckel and Rawert are more particularly, drawn to inhalation via soft mist inhalers, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a soft mist inhaler having all of the claimed features of instant claim 50 in Voswinckel/Parikh, as suggested by Rawert with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Voswinckel generally teaches soft mist inhalers as suitable for administering treprostinil and Rawert teaches a soft mist inhaler having said features as effective and suitable to administer aerosolized medication.
Thus, the combined teachings of Voswinckel, Parikh and Rawert render the instant claims prima facie obvious.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Voswinckel et al. (“Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension”, Pulmonary Pharmacology & Therapeutics 22 (2009) 50–56; hereafter as “Voswinckel”) in view of Parikh et al. (“Safety and Tolerability of High-dose Inhaled Treprostinil in Pulmonary Hypertension”, J Cardiovasc Pharmacol, 2016 Apr; 67(4):322-5; hereafter as “Parikh”), Olschewski et al. (US 2008/0200449 A1, Aug. 21, 2008, hereafter as “Olschewski”) and Chen et al. (US 2017/0050945 A1, Feb. 23, 2017, hereafter as “Chen”).
The claimed invention is described above.
Voswinckel and Parikh teach the elements discussed above.
Voswinckel and Parikh are silent to a kit, wherein the kit comprises a first contain comprising a first liquid composition and a second container comprising a second liquid composition.
Olschewski teaches a kit for treating pulmonary hypertension in a subject, comprising (i) an effective amount of treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, (ii) a metered dose inhaler (e.g., a soft mist inhaler), and (iii) instructions for use in treating pulmonary hypertension ([0012] and [0042]).
Chen teaches a kit comprising an inhalation device such as a soft mist inhaler ([338] and [0340]). Chen also teaches that the kits can have multiple different compositions and/or multiple different dosages of the same composition ([0408]).
The references are all generally drawn to inhalation methods, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a kit comprising a soft mist inhaler and two containers comprising different dosages of treprostinil in Voswinckel/Parikh, as suggested by Olschewski and Chen, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Olschewski generally teaches that kits comprising an effective amount of treprostinil and a soft mist inhaler is known for the treatment of pulmonary hypertension; kits are generally known to be a convenient mechanism to disperse products to consumers; and Chen generally teaches kits comprising inhalation devices such as a soft mist inhaler and multiple different compositions and/or multiple dosages of the same composition. One of ordinary skill would have reasonably expected a kit comprising a soft mist inhaler, a first liquid composition comprising treprostinil in a concentration of about 1 mg/ml to about 3 mg/ml, and a second liquid composition comprising treprostinil in a concentration of about 2 mg/ml to about 4 mg/ml, wherein the second liquid concentration of treprostinil in the second liquid composition is higher than the first concentration of treprostinil in the first liquid composition.
Thus, the combined teachings of Voswinckel, Parikh, Olschewski and Chen render the instant claim prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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