DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 08/13/2026, is acknowledged.
Applicant has previously elected without traverse. the invention of Group I, claims 1-11, 14 are drawn to a composition comprising monohydric alcohol, HFA152a and/or HFO1234ze, and albuterol sulfate and/or levalbuterol tartrate.
Claims 1-2, 4, 6-7, 9-25 are pending in this action. Claims 3, 5, 8 have been cancelled previously. Claims 1-2, 6-7, 9-11, 13, 17-18, 20-24 have been amended. Claims 12-13, 15-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1-2, 4, 6-7, 9-11, 14, 17-25 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application, filed 03/07/2024, does not claim benefit of provisional U.S. Application, and/or benefit of foreign priority.
Specification
The specification is objected to because of the following informalities:
The specification comprises acronym “HFO” (e.g., Pages 2-4, 6). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The specification comprises the typographic error “85 wt% HFA152a” (Page 2) that needs to be corrected to “85 wt% of HFA152a”. In response to applicant’s argument that said correction is not required, it is noted that on page 6 of the instant specification and/or in claims 1, 9 said limitation is recited as “85 wt% of HFA152a”.
Claim Objections
Claims 6, 7 are objected to because of the following informalities: Claim 6 comprise the typographic error “the albuterol sulfate” that needs to be corrected to “albuterol sulfate”. Similar is applied to claim 7. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4, 6-7, 9-11, 17-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As stated previously, claim 1 recites the limitation “at least 85% of HFA152a” that is not reasonably, because the recited numerical limitation is not clearly delineated. Can it be 100 wt%? Similar is applied to claim 17. Clarification is required.
In response to the applicant’s argument that one skilled in the art would understand said limitation, it is noted that said limitation does not clearly define the concentration of the compounds to be included in the claimed composition that also may include unrecited compounds even in a large amount (i.e., comprising). Can the concentration of HFA152a be 92 wt%, or 95 wt%, etc.? To this point, it is noted that the main purpose of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent; and to provide a clear measure of what the applicant regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability. MPEP 2173. Clarification is required.
As stated previously, claim 2 recites the limitation “the monohydric alcohol comprises a C1-C3 monohydric alcohol” that is unclear. Does this limitation imply that said monohydrate alcohol is a mixture, i.e., may include other compounds even in large amounts (i.e., comprising)? Similar is applied to claim 18, as well as to claims 10, 23 regarding the limitation “surfactant comprises”. Clarification is required.
In response to the applicant’s argument that one skilled in the art would understand the scope of said limitation, it is noted that in the present case it is unclear what is disclosed as “monohydric alcohol comprising a C1-C3 monohydric alcohol”. Is it a mixture that may include at least one C1-C3 monohydric alcohol”, OR “monohydric alcohol is selected from the group consisting of methanol (CH₃OH), ethanol (C₂H₅OH), propanol (C₃H₇OH) and a mixture thereof? Similar is applied to claims 10, 23 regarding the limitation “surfactant comprises”. Clarification is required.
Claim 7 recites the limitation “ratio of the albuterol sulfate and/or levalbuterol tartrate to the monohydric alcohol is from 1 to 30 wt.%” that is unclear. In the present case, it is unclear what ratio should be measured in “wt%”. Similar is applied to claim 21. Clarification is required.
Claim 11 (dependent on claim1) recites the limitation “composition consists essentially of … and a balance being HFA152a together with any unavoidable impurities” that is not reasonably clear. First, it is noted that the instant specification clarifies the term “consist essentially” as further components may be present that do not materially affect the essential characteristics of the composition. In the present case, it is unclear what characteristics of the composition are considered to be “essential”. Second, it is unclear what should be balanced. To this point, it is noted that claim 1 discloses compositions comprising “at least 85 wt% of HFA152a in a combination with recited compounds. Therefore, it is unclear what balance said limitation refers to. Similar is applied to claim 24. Clarification is required.
Claims 4, 6, 9, 14, 19-20, 22, 25 are rejected as being dependent on rejected independent claims 1 and 17 and failing to cure the defect.
Claim Rejections - 35 USC § 102(a)(1)/103
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.
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.
Claims 1-2, 4, 6-7, 9-11, 17-25 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rote et al., WO 2024/033941 (pub. date 02/15/2024; cited in IDS; hereinafter referred to as Rote).
Rote teaches pharmaceutical compositions for inhalation, wherein said compositions can be administered or delivered by using pressurized metered dose inhaler (Claim 6; Abstract; Pages 7, 10-11 as applied to claims 1, 17), and can be used to treat asthma (Pages 9-10 as applied to claim 25). To this point, Rote teaches that said compositions may include:
0.1-0.8 wt% of salbutamol/albuterol sulfate and/or levalbuterol/levosalbutamol tartrate (Claims 8-9; Abstract; Pages 6, 9, 13-14 as applied to claim 1, 4, 6, 9, 11, 17, 19-20, 22, 24);
at least 80%, or 90%, or 99% of HFA-152a (Claims 1, 9; Abstract; Pages 5, 15-17 as applied to claims 1, 9, 17, 22);
1-10 wt% of a solvent/ethanol (as a preferred solvent), i.e., monohydric alcohol (Claims 1, 4-5; Pages 6, 12-13 as applied to claims 1-2, 11, 17-18, 24);
0.001-2 wt% of a surfactant, e.g., oleic acid, polyethylene glycol (Claims 1-3; Pages 6, 13 as applied to claims 10-11, 23-24).
Therefore, the cited reference discloses compositions, which are identical to the presently claimed compositions, i.e., comprise compounds as instantly claimed in claimed amounts. Consequently, said claims appear to be anticipated by the reference recited. Alternatively, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to prepare the compositions as taught by Rote to be used for treatment of asthma. One would do so with expectation of beneficial results, because Rote teaches that said compositions are suitable for oral or nasal inhalation route, and the administration or delivery of said compositions can be done using pressurized metered dose inhaler, or breath actuated inhaler, or nebulizer. Accordingly, the claimed invention as a whole is at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary. Claims 7, 21 are rejected as being dependent on rejected base claims.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WO 2024/013455A1 (cited in IDS) - teaches a pharmaceutical composition consisting of (i) an active ingredient, i.e., salbutamol/albuterol sulfate; (ii) 87.5-99.89 wt% of 1,1-difluoroethane/HFA152a; (iii) 0.05-10 wt% of ethanol/monohydric alcohol, and (iv) 0.01-2 wt% of a surfactant; e.g., oleic acid, polyethylene glycol; and wherein said composition can be used in a metered-dose inhaler for the treatment of asthma (Abstract; Presentation of the invention).
WO 2023/118717A1 (cited in IDS) - teaches a pharmaceutical composition consisting of (i) an active ingredient, i.e., salbutamol/albuterol sulfate; (ii) 1,1-difluoroethane/HFA152a; (iii) ethanol/monohydric alcohol, and (iv) a surfactant; e.g., oleic acid; and wherein said composition can be used in a metered-dose inhaler for the treatment of asthma (Abstract; Technical area).
Response to Arguments
Applicant's arguments, filed 08/13/2026, have been fully considered, and they were not found to be persuasive. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the claim language, the structure of the claimed product, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the reference cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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