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 .
Request for Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/20/2026 has been entered.
Status of the Claims
Claims 1-12, 21-27, 29, 30, and 33-38 are pending. Acknowledgment is made of the amendment of claims 1, 2, 26, 29, 30, and 36 and the cancellation of claim 28 in the reply filed 03/20/2026.
Restriction Requirement
Applicant elected, with traverse, Group I, drawn to a method of treating a virus comprising administering azelastine, in the reply filed on 07/29/2025.
Withdrawn Objections/Rejections
Applicant’s amendment to the claims, filed 03/20/2026, overcomes the objection to claim 36 for minor informalities. The objection to claim 36 has been withdrawn.
Applicant’s amendment to the claims, filed 03/20/2026, overcomes the rejection of claims 1-12, 21-30, and 33-38 under 35 U.S.C. 112(a) for the introduction of new matter. The rejection of claims 1-12, 21-30, and 33-38 has been withdrawn.
Applicant’s cancellation of claim 28, in the claims filed 03/20/2026, renders the rejection of claim 28 under 35 U.S.C. 112(d) moot. The rejection of claim 28 has been withdrawn.
New Rejections
Necessitated by Claim Amendment
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.
Claims 1-12, 21-27, 29, 30, 33-36, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the drug Astelin (Astelin: Package Insert/Prescribing Info, Drugs.com, U.S. Approved 1996, accessed 11 August 2025).
The nasal spray Astelin, approved for human use in 1996, is taught to treat rhinitis. As evidenced by Luers et al. (Olfactory and Gustatory Dysfunction in Coronavirus Disease 2019 (COVID-19), Clinical Infectious Diseases, 01 May 2020, Vol. 71, pages 2262-2264), over half of patients with SARS-CoV-2 present with rhinitis as a result of the SARS-CoV-2 infection.
The prior art is silent regarding using the composition to treat SARS-CoV-2. However: treating SARS-CoV-2 will inevitably flow from the teachings of the prior art (see above reasoning), since the same composition (Astelin, or Azelastine hydrochloride) is being administered to the same subjects (a subject suffering SARS-CoV-2 induced rhinitis). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
Even though the prior art is silent regarding treating SARS-CoV-2, by practicing the method taught by the prior art, administration of the composition to a subject with SARS-CoV-2 in order to treat rhinitis will also be treating the SARS-CoV-2 even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (treating SARS-CoV-2) of the method taught by the prior art (treating rhinitis comprising administering Astelin). However, an individual treating rhinitis caused by SARS-CoV-2, since over half of individuals with SARS-CoV-2 also suffer from rhinitis, would inherently be using the instant invention, as in instant claims 1-6, 8, 9, 11, 12, 21-25, 29, 30, 33-36, and 38.
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Astelin comprises azelastine hydrochloride in 137 μg per spray, at 0.1% Azelastine hydrochloride, with a pH of 6.8, as in instant claims 7, 10, and 26. Astelin is taught to be administered twice daily, as in instant claim 27.
Claims 1, 2, 4-12, 21-27, 29, 30, and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldin (US 8,642,069 B2).
Goldin teaches, in claims 1 and 14, a method of treating a viral upper respiratory infection comprising administering Azelastine and olopatadine. In Study 2, shown in Table 3, nineteen participants who had either coronaviruses or RSV were treated with compositions comprising Azelastine, as in instant claims 1, 2, 4-6, 11, 12, 29, 30, 37, and 38. It is taught in claim 15 that the dosage form is a nasal spray, as in instant claims 8, 9, 21-25, and 36.
The specific Azelastine nasal spray which was used was Astelin (U.S. approved in 1996), which delivers .137 mL of solution and 137 μg azelastine hydrochloride per spray, which is 0.1% Azelastine hydrochloride and a pH of 6.8, as in instant claims 7, 10, and 26. Astelin is used twice daily, as in instant claim 27.
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.
Claims 3 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Goldin (US 8,642,069 B2) as applied to claims 1, 2, 4-12, 21-27, 29, 30, and 36-38 above.
Goldin teaches a method of treating coronaviruses comprising administering a nasal spray solution of Azelastine. See above rejection.
Goldin fails to teach a method of treating SARS-CoV-2 using this method.
However, SARS-CoV-2 did not exist when the method by Goldin was discovered, and Goldin broadly taught the treatment of “coronaviruses” using the method described above. Due to the outbreak of SARS-CoV-2, large-scale compound repurposing was performed in order to find a treatment method. It would be prima facie obvious to one of ordinary skill in the art to test Azelastine, which is known to treat coronaviruses, in order to treat a new strain of coronavirus, SARS-CoV-2, and variants or mutants thereof.
Azelastine is an H1 histamine blocker. As evidenced by Gordon et al. (A SARS-CoV-2 protein interaction map reveals targets for drug repurposing, Nature, 30 April 2020, Vol. 583, pages 459-467), other H1 histamine blockers, such as clemastine, cloperastine, and astemizole, were identified as promising drug candidates to treat SARS-CoV-2. One would have a reasonable expectation of success in using a method known to treat coronaviruses comprising the H1 histamine blocker Azelastine on a new coronavirus, SARS-CoV-2, and variants or mutants thereof, since it is used to treat other coronaviruses, and similar histamine blockers have been taught to be used to treat SARS-CoV-2.
Conclusion
Claims 1-12, 21-27, 29, 30, and 33-38 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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