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 .
DETAILED ACTION
The office acknowledges Applicants filing of the arguments and claim amendments on 12/8/2025 in response to the office action dated 10/16/2025. Claims 1, 26-27 has been amended. Claims 1, 17-29 are pending. Claims 28-29 are withdrawn from further consideration. Rejections not reiterated have been withdrawn. Applicants arguments have been fully considered but are moot in light of the new rejections necessitated by the claim amendments. The rejection is made final. Claims 1, 17-27 are examined based on the elected invention and species (see response to restriction election on 9/2/2025).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Rawert et al. (WO 2021198154, effective filing date: US prov. 31 March 2020).
Rawert teachings relates to the field of inhalation methods and inhalation devices for liquids. The reference teaches a first reservoir containing a first liquid composition comprising a long-acting beta agonist and a second reservoir containing a second liquid composition comprising an inhaled corticosteroid, wherein the first and second reservoirs are adapted for use with an inhalation device (see claim 29). The first liquid composition comprises a long-acting beta agonist (LABA), preferably in a pharmaceutically effective amount, e.g. formoterol, or LAMA, e.g. glycopyrronium bromide; in some embodiments, the first liquid composition comprises a mixture of a long- acting beta agonist and a long-acting muscarinic antagonist; in some embodiments, the second liquid composition comprises an inhaled corticosteroid (ICS), e.g. beclomethasone (claims 13-15, p 18, lines 18-29, p 19, lines 3-5). In another embodiment of the invention, a single dose of the first liquid composition and the second liquid composition may be released by a one (single) actuation, or a plurality of actuations of the inhalation device (p 11, lines 26-28). The single doses of the first and second liquid composition may have the same or different mass ranging from about 0.1-1000 ug (see p 11, last three lines). The first and the second liquid compositions comprise solvents, e.g. ethanol (see claim 18, p 18, lines 5-6). The liquid carrier or solvent comprises water and/or ethanol, preferably ethanol. In further specific embodiments, such liquid carrier or solvent comprises or preferably consists of ethanol or a mixture of ethanol and water, wherein the ethanol may be comprised in an amount of at least about 70 wt.-% or even more and water. In specific embodiments, the liquid vehicle or solvent comprises or consists of ethanol in an amount of about 60 to about 80 wt.% (p 18, lines 5-16). A further aspect of the present invention relates to the use of the inhalation device in treatment of a disease or condition, e.g. COPD (claim 28, p 20, line 25). The present invention provides for the use of an inhalation device or reservoirs containing the first and second liquid compositions, e.g. soft-mist inhaler (claims 24-25, p 10, last para). The reference teaches cartridges that houses one or more reservoirs that may be removed from the device and replaced when the reservoirs are empty; the inhalation device wherein the first reservoir and the second reservoir are incorporated into a single cartridge (claim 12, p 5, lines 19-22).
From the teachings of Rawert et al. a person skilled in the art would have found it obvious to arrive at the claimed pharmaceutical solution composition comprising an inhaled corticosteroid, e.g. beclomethasone and a LABA, e.g. formoterol dissolved in at least 80% ethanol solvent and the composition incorporated in a cartridge which is compatible with soft mist inhaler. From Rawert a person skilled in the art would have been motivated to formulate a solution that comprises solvent ethanol (e.g. 80%) beclomethasone and formoterol when incorporated in single cartridge that is compatible with a soft mist inhaler with a reasonable amount of success and to use it to treat COPD disorder. Thus claims 1, 17, 19-20 are addressed. As to claim 18, Rawert teach the solvent ethanol can be present in an amount of 70% or 80% or more. Hence it would have been obvious to a skilled artisan to utilize 90% ethanol solvent in the composition. As to the ratio amounts of ICS to LABA and ICS, LABA, LAMA in claims 21-22, Rawert teach that the dose of the active agents in the composition range from about 0.1-1000 ug. Hence it is within the skilled artisan to arrive at the claimed ratios. For e.g. if 1000 ug of each of ICS, LABA is in the composition, the weight ratio % is 50:50. If for e.g. 1000 ug of each of ICS, LABA and LAMA is in the composition, the weight ratio by % would correspond to 50:50:50% respectively.
As to claim 23, Rawert teach one or more buffering agents to regulate or control pH of the solution can be added to the composition (see p 19, line 4).
As to claim 24, Rawert teach that the liquid compositions are also essentially free of a propellant such as a hydrofluoroalkane (HFA) propellant (see p 20, lines 2-3).
As to claim 25, the composition need not contain any preservative and it is optional to add them (see p 19, line 29).
As to claim 26, a person skilled in the art would have found it obvious to make a cartridge that comprises the pharmaceutical solution comprising inhaled corticosteroid, e.g. beclomethasone and LABA, e.g. formoterol, ethanol (80%) that is compatible with a soft-mist inhaler from Rawert’s teachings. A person skilled in the art would have been motivated to arrive at the claimed cartridge with a reasonable amount of success and use it to treat COPD disorder.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Rawert et al. (WO 2021198154, effective filing date: US prov. 31 March 2020) in view of Remington (Science and Practice of Pharmacy, Nineteenth edition, vol. 1, p 806, 1995).
Rawert teachings as discussed above. The above rejection is incorporated herein.
Rawert do not teach the kit comprising the cartridge as claimed.
Remington’s: the Science and Practice of Pharmacy, Nineteenth edition, vol. 1, p 806 teaches the inclusion of package and insert including the “indications and use” of the pharmaceutical composition is mandated by 21 CFR 201.57.
It would have been obvious to a skilled artisan before the effective filing date of the invention to have arrived at the claimed kit comprising the cartridge and the soft mist inhaler.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to package components into a kit from the teachings of Remington. Commercial packages for pharmaceutical compositions are well known in the art, and specifically disclosed by US Dept. of Health and Human Services, FDA Guidance for Industry. Accordingly, in further view of US Dept. of Health and Human Services, FDA Guidance for Industry, the skilled artisan would have immediately envisaged a commercial package, e.g. container comprising the cartridge and the soft mist inhaler. The skilled artisan would have done so in order to provide a medicament which can be easily administered by a patient with a reasonable expectation of success. A person of ordinary skill in the art at the time of the invention would have found it obvious to place such formulation in a kit (e.g. bottle, container or dispenser) to provide convenience to end user. One would be motivated to provide a kit comprising the cartridge and soft mist inhaler in a kit to provide inhalation medication for the COPD subjects. Thus claim 27 is addressed.
Claim(s) 1, 17-27 are rejected under 35 U.S.C. 103 as being unpatentable over Radau et al. (US 20080041370 A1) in view of Jabbal (Clinical Exp Allergy, 2020, 50, 1140-47) and Andreas et al. (Pulmonary Pharmacology & Therapeutics, 52, 2018, 1-6).
Radau teach an aerosol medicament formulation comprising a beta-agonist and a steroid, e.g. beclomethasone and solvent ethanol, acceptable buffer system, the amount of ethanol by volume is in the range of 30-99% (See abstract, claim 1, 3, 14-15, 22, 24 and 25). The content of the first and the second active agent in the medicament independently can range from 0.1-600 mg per 100 ml of solution in each case.
Radau is not explicit in teaching the long acting beta agonist, for e.g. the elected species, formoterol in the formulation.
Jabbal teach that the use of medium and high fine extra fine beclomethasone/ formoterol/glycopyrronium combination and beclomethasone/formoterol for asthma therapy. Jabbal teach that olodaterol with the LAMA tiotropium (OLO/TIO), both delivered via the soft mist Respimat inhaler and once daily ultra-long acting bronchodilator as the LABA olodaterol (See p 1141, col. 2, lines 8-10).
Andreas teach formoterol and olodaterol are long acting beta-2 agonists and is used in COPD patients (See Abstract).
From Jabbal and Andreas a person skilled in the art before the effective filing date of the invention would have found it obvious to add LABA, formoterol to Radau’s formulation because (i) Jabbal teach triple combination therapy comprising formoterol for asthma (ii) Jabbal further teach Respimat inhaler comprising long acting beta agonist, olodaterol (single therapy) or in combination with tiotropium (iii) Andreas teach the equivalence of two LABA agents, formoterol and olodaterol. Hence a skilled artisan would have been motivated to add formoterol to Radau’s formulation that comprises beclomethasone and incorporate into cartridge that is compatible with soft mist inhaler (e.g. Respimat) with a reasonable expectation of success and use it in COPD subjects as a bronchodilator. As to ethanol Radau teaches the solvent in the range of 30-99%. Hence a skilled artisan would have found it obvious to formulate the composition comprising at least 90% of ethanol for example. Thus claims 1, 17-20 are addressed. As to the ratio amounts of ICS to LABA and ICS, LABA, LAMA in claims 21-22, Radau teach the first and the second active agent in the medicament independently can range from 0.1-600 mg. Hence it is within the skilled artisan to arrive at the claimed ratios. For e.g. if 0.1 mg of each of ICS, LABA is in the composition, the weight ratio % is 50:50. If for e.g. 0.1 mg of each of ICS, LABA and LAMA is in the composition, the weight ratio by % would correspond to 50:50:50% respectively.
As to claim 23, Radau teach adding buffering systems to the composition.
As to claim 24, the composition formulated from the prior art can be free of propellant.
As to claim 25, the composition need not contain any preservative and it is optional to add them.
As to claim 26, a person skilled in the art would have found it obvious to make a cartridge that comprises the pharmaceutical solution comprising inhaled corticosteroid, e.g. beclomethasone and LABA, e.g. formoterol, ethanol (80%) that is compatible with a soft-mist inhaler from the combined prior art teachings. A person skilled in the art would have been motivated to arrive at the claimed cartridge with a reasonable amount of success and use it to treat COPD disorder.
As to claim 27, Radau teach an inhalation kit consisting of one of the pharmaceutical preparations according to the invention and the Respimat.RTM. inhaler (see [0136]). Thus one skilled in the art would have found it obvious to arrive at the kit as claimed.
Claim Objections
Claim 1 is objected to because of the following informalities: ‘the limitation, “wherein the pharmaceutical solution composition is incorporated into a cartridge compatible with a soft mist inhaler” is repeated (See line 2 and lines 8-9). It is suggested that this limitation be deleted. Appropriate correction is required.
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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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627