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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/31/25 and 4/24/26 were filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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) 1, 2, 16, 23-27, 40, 41, 43 and 45 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Chipps et al (Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged > 4 years with moderate-to-severe asthma: rationale and design of the randomized, double-blind, active-controlled MANDALA study, BMJ Open Res 2021, 8 hereafter Chipps).
Chipps discloses a method of treating asthma in a subject at risk for exacerbation comprising administering to said patients a composition comprising an effective amount of albuterol and budesonide in a metered dose inhaler , where the method reduced risk of severe asthma exacerbation by at least 15% and up to 25% (abstract, page 5), meeting limitation of claims 1, 2 and 40. The administering comprises 180 micrograms of albuterol and 80 and 160 micrograms, at a ratio from of about 1.1:1 or about 1.25:1 or 2.25:1 (pg 2), meeting limitations 23-27, and 29. The subject of the method can be in either of two groups, aged 4-11 or aged > 12 years old (pg. 2), meeting limitations 41 and 43. The subject is not administered more than 6 doses a day (page 2-3), meeting limitations of claims 45. These disclosures render the claims anticipated.
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.
Claim(s) 1, 2, 12, 16, 23-27, 29-35, 40, 41, 43 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Chipps et al (Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged > 4 years with moderate-to-severe asthma: rationale and design of the randomized, double-blind, active-controlled MANDALA study, BMJ Open Res 2021, 8 hereafter Chipps) in view of Vehring et al (US 2012/0039952 A1 hereafter Vehring) and Knopeck et al (US 2016/0324778 A1 hereafter Knopeck).
As discussed above, Chipps discloses a method of treating asthma by administering to a subject in need thereof a metered dose inhaler comprising a combination of albuterol and budesonide. The reference does not however disclose the components of metered dose inhaler such as the propellant used or the suspension agent used in the formulation. These components are well known in the art as seen in the Vehring patent.
Vehring discloses a metered dose inhaler formulation that delivered suspended of particles [abstract]. The formulation is a co-suspension of active agents and propellants [0005]. The propellants can be hydrofluoroalkane propellant [0083]. The particles of the active agent particles measure in size from about 1-7 microns [0091]. The active agents can include common anti-asthma compounds like albuterol and budesonide [0098]. The MDI can deliver about 80 micrograms per dose [0135]. The FEV1 increases after use to at least 100 mL [0156]. The suspending agents is DSPC [0180]. The active agents can be crystallized and micronized [0018, 0092 and 0095]. It would have been obvious to provide this formulation as the carrier formulation for the formulation of Chipps as they solve the same problem with similar components.
While the combination would comprise hydroflouro propellant, they do not disclose the propellant of claims 34. The use of this compound is known in the art seen in the Knopeck patent.
Knopeck discloses a metered dosage inhaler formulation a device [abstract, Figure]. The formulation can be a suspicion of active agents particles comprising a propellant, where the propellant is a hydrofluoroolefin [0042]. The active agents can be anti-asthma compounds [0026]. The propellant can be a transHFO-1234ze (1,3,3,3-tetrofluoro-1-propene) [claims]. It would have been obvious to include this propellant as it is similar to the propellant of the combination and solve the same problem.
With these aspects in mind, it would have been obvious to combine the prior art with an expected result of a stable method of treating severe asthma. It would have been obvious to combine the components of Vehring and Knopeck into the formulation of Chipps as they solve the same problem and can be used in the same method of treating severe asthma with similar active agents. One of ordinary skill in the art would have been motivated to combine the prior art to form a stable means of treating severe asthma quickly and reducing asthma exacerbation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
