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
Claims 1-12 are pending and are now evaluated on its merits.
Priority
This application is a continuation of application 18/082,353, filed 12/15/2022, which claims domestic benefit to U.S. provisional application 63/290,285, dated 12/16/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 7/17/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file, and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility. The use of the phrase “for use” makes it unclear of which statutory class the claims fall under. The claims language set no statutory class of a method of use or composition of matter.
Claim Rejections - 35 USC § 112
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.
Claim 12 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, the phrase "for use" renders the claim indefinite because it is unclear which statutory class the claims fall into. If they are meant to be a method, an active step is missing. If they are meant to be a composition of matter, it is unclear if the “use” is a future intended use. The claim refers to a use of the composition without setting the limitation for the intended use of the composition. Should applicant intend the claim to be a method of treatment claim the following language is suggested:
A method of treating coronavirus disease comprising administrating a composition comprising a combination of levocetirizine and montelukast to a subject in need thereof.
Claim Rejections - 35 USC § 102
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 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 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by May (U.S. Patent No. 20200323843).
Regarding claims 1-12, May teaches a method for treating a patient having a viral infection caused by coronavirus (relevant to claim 12) (claims 33 and 41) in addition to the symptoms of chills and nasal congestion (relevant to claims 2) (para. 0106, 0112, example 1) comprising administration of a composition of levocetirizine (para. 0070, tables 1-5) and montelukast (para. 0071) (relevant to claims 1, 11). The composition is administered in a sequential and simultaneous manner (relevant to claims 3-4) (para. 0010, claims 27-28) by one or more routes of enteral, intravenous, intraperitoneal, inhalation, intramuscular, subcutaneous and oral (relevant to claim 5) (para. 0073, 0092, claim 29).
May teaches the levocetirizine and montelukast composition administered by the same route as well as by different routes (relevant to claims 6-7) (para. 0007, claims 29-30). May further teaches a levocetirizine and montelukast modified release composition (relevant to claim 8) (abstract) further comprising a steroid (relevant to claim 10) (para. 0069, claim 31) and naproxen which is known in the art to be an antipyretic (relevant to claim 9) (table 7-8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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, Kortney Klinkel can be reached at 571-270-5239. 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.
MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights