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 .
Receipt is acknowledged of the amendment filed 02/10/2026.
Information Disclosure Statement
Information disclosure statements were filed on 02/10/2026 and 04/30/2026.
Claim Status
Claims 1,2, 4-9, 14, 17-21, and 24-25 are present in the application.
Withdrawn Rejections
The rejection made under 35 USC 112, second paragraph, the rejection under 35 USC 102(a)(1) over Guthappa , the rejection under 35 USC 103 over Goc (WO 2022/03459A1), the rejection under 35 USC 103 over Niedzwiecki et al (US Patent No. 11,419,847), are all withdrawn in view of the amendments made on 02/202/2026.
New Rejection and Objection
Specification
The abstract of the disclosure is objected to because it is no longer commensurate with he claimed invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: The disclosure lacks a Brief Description of the Drawings.
Appropriate correction is required.
Claim Objections
Claim 21 objected to because of the following informalities: It is not in proper form for a claim. Specifically, as per MPEP 608.01(m), the claim must end in a period. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, and 4-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) determined that factors which enable an invention. These are:
(A) The breadth of the claims;
The instant claims set out a treatment for coronavirus comprising administering usnic acid or a salt thereof, hydroxypropyl methylcellulose and cyclodextrin.
(B) The nature of the invention ;
The composition is used for its claimed antiviral properties.
(C) The state of the prior art;
The prior art concerns usnic acid , sometimes in combination with cyclodextrin..
(D) The level of one of ordinary skill.
The ordinary practitioner is either a PhD or medical practitioner
(E) The level of predictability in the art;
As with any infection, patient response to medication is not always predictable. This is especially the case for coronavirus and its various symptomology , especially in immunosuppressed patient.
(F) The amount of direction provided by the inventor;
No direction is given as to treatment protocols, dosage or frequency.
(G) The existence of working examples;
There are no working examples on the treatment of coronavirus infection in any patients. All data appears to be in vitro.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Because each patient response is unique to the coronavirus, each one must be evaluated by carefully step by step as to dosage, frequency, patient skin reaction, and efficacy. This involves painstaking, undue experimentation to determine what is efficacious, what if any side effects such as embolism, and frequency of administration.
The claim for treatment of coronavirus in those in need thereof is not enabled by the original specification.
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 21 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 21 recites the broad recitation of concentration ranges, and the claim also recites narrower ranges of concentration which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Applicant is encouraged to rewrite the claim in sentence form to more particularly point out the claim limitations in a definite manner.
Conclusion
No claims are allowed. Claims 14, 17-20, 24 and 25 are objected to as dependent upon a rejected base claim.
US Patent No. 11,419,847 is cited as state of the art in its disclosure of combining usnic acid with cyclodextrin.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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