DETAILED ACTION
Status of Application
Receipt of the response to the restriction/election requirement, the amendments to the claims and applicant arguments/remarks, filed 06/03/2026, is acknowledged.
Applicant has elected 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. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse. MPEP § 818.01(a).
Claims 1-2, 4, 6-7, 9-25 are pending in this action. Claims 3, 5, 8 have been cancelled. Claims 12-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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, 9, 11 have been amended. New claims 17-25 have been added. No new matter was added. Claims 1-2, 4, 6-7, 9-11, 17-25 are currently under consideration.
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.
Inventorship
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.
Specification
The specification is objected to because of the following informalities:
The specification comprises multiple acronyms, e.g. “NFO” (Page 2), “BOL”, “MOL”, EOL” (Page 10) without proper definition. 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”
Information Disclosure Statement
The information disclosure statements, filed 05/13/2024, 03/14/2025, 07/24/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Claim Objections
Claims 1, 7, 9, 11, 20-22, 24 are objected to because of the following informalities:
Claim 1 comprises acronym “HFA”. The acronym should be given once in parenthesis after the first use of the full term (i.e., hydrofluoroalkane), and then the acronym is used alone thereafter if needed.
Claim 1 comprises the typographic error “85 wt% HFA152a” that needs to be corrected to “85 wt% of HFA152a”. Similar is applied to claim 17.
Claim 7 comprises the typographic error “the ratio … is from 1 to 30” that needs to be corrected to “a ratio … is from 1 to 30”. Similar is applied to claim 21.
Claim 9 comprises the typographic errors “wt% of the HFA152a”, “wt% of the albuterol sulfate” that needs to be corrected to “wt% of HFA152a”, “wt% of albuterol sulfate”, respectively. Similar is applied to claims 11, 20-22, 24.
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.
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.
Claims 1, 17, 25 provide for the “use” of a composition but, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Clarification is required.
Claims 2, 6-7, 10-11, 18, 20-21, 23 are unclear and indefinite, because the claims recite a broad range/limitation together with a narrow range/limitation (i.e., preferably, more preferably) that falls within the broad range/limitation in the same claim. Therefore, the resulting claims do not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Clarification is required.
Claim 2 recites the limitation “the monohydric alcohol comprises a C1-C3 monohydric alcohol” that is not clear. Does this limitation imply that said monohydrate alcohol may include other compounds even in large amounts (i.e., comprising). Similar is applied to claim 18. Clarification is required.
Claim 10 recites the limitation “a surfactant, preferably one or more of oleic acid, polyethylene glycol, …, and polyoxyethylene” that is not reasonably clear. This limitation was interpreted as best understood as “a surfactant selected from the group consisting of oleic acid, polyethylene glycol, …, polyoxyethylene, and mixtures thereof”. MPEP §803.02. Similar is applied to claim 23. Clarification is required.
Claim 11 recites the limitation “the balance being HFA152a together with any unavoidable impurities” that is not reasonably clear, because it is not clearly stated to which balance said limitation refers. Similar is applied to claim 24. Clarification is required.
Claims 4, 9, 19, 22 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)
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.
Claims 1-2, 4, 6-7, 9-11, 17-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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, 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, claims 1-2, 4, 6, 9-11, 17-20, 22-25 are anticipated by the reference recited. Claims 7, 21 are rejected as being dependent on rejected base claims. 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.
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).
Conclusion
No claim is allowed at this time.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 6/26/26
Prosecution Insights