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 (RCE)
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/16/26 has been entered.
Priority
This application is a 371 of PCT/KR2021/007104 (06/08/2021) and claims foreign priority to KOREA, REPUBLIC OF 10-2020-0069697 (06/09/2020).
Status
Claims 1-11 are pending.
Any rejection not reiterated in this action is withdrawn.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-11 are rejected under 35 U.S.C. 112(a) 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.
Claim 1 is to a “method of preventing or treating a viral infection comprising administering to a subject in need thereof an antiviral composition comprising …” a list of various unrelated pharmaceutical agents. The instant disclosure does not contain sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention upon consideration of the factors set forth in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), as follows. See also MPEP § 2164.01(a) and § 2164.04.
The breadth of the claims – the claims are to a method of “preventing or treating a viral infection” by administering a genus of unrelated pharmaceutical agents.
The nature of the invention – the nature of the claimed invention is to affect treating and preventing by “inhibiting” a virus.
The state of the prior art – the therapeutic approach of administering unrelated compounds for treating or preventing viral disease is unknown and Applicant cites no known mechanism or expectation that the approach would be successful. Applicant states that there were no approved therapeutics for treating COVID-19 at the time of filing (Specification p. 1-2)
The level of one of ordinary skill – the level of skill in the art is high as evidenced by WHO (“Clinical management of COVID-19 Interim guidance,” World Health Organization: WHO/2019-nCoV/clinical/2020.5, 27 May 2020, 62 pages).
The level of predictability in the art – the art is highly unpredictable due to the complex nature of the disease and the unknown mode of action of the compounds used. The particular art is also unpredictable because there is no known or articulated rationale for how the compounds are alleged to induce antiviral effect.
The amount of direction provided by the inventor – the primary guidance provided by the Applicant is given in the Examples and appears to be an evaluation of a series of compounds with experimental data (p. 14-19). However, nowhere in the disclosure is the data discussed or is stated that the experiments were performed and are annotated with “CPE” and “image” without explanation. In addition, the EC50, CC50, SI numbers are reported with “>” suggesting that the actual value was unknown, but above a threshold. This lack of clear explanation and supporting data would cause one of skill in the art to question whether the examples support enablement of the claims. Regarding dosing and effective amounts, all of the guidance provided regarding dosing and effective amounts is completely generic without any specificity related to any experimental data of compounds within the claims.
The existence of working examples – there are no working examples of the claimed pharmaceuticals preventing or treating viral disease.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure – given the high level of unpredictability in the art, the lack of working examples, and the limited and unclear guidance provided in the examples, there would be a tremendous amount of experimentation required before one of skill in the art could prevent or treat disease in a subject.
In view of the specification and the unclear evidence of record, one of skill in the art would be required to perform an undue amount of experimentation to test each of the compounds of the claims using an appropriate model to select candidates for further development in vivo, perform testing to determine dosing, and finally efficacy testing. Thus, one of skill in the art would be required to start ab initio and develop any pharmaceutical within the scope of the claims. Such a level of experimentation is undue. Weighing the above factors by a preponderance of the evidence results in the conclusion that the claims are not enabled for preventing or treating a SARS-coronavirus-2/COVID-19 viral infection in a subject with the pharmaceuticals claimed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gwaltney (US5422097).
The reference teaches treating a coronavirus with brompheniramine (claim 5).
Claims 1-2, 4-5, 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MacMillan (US20040029864).
MacMillan teaches treating colds caused by coronavirus by administering brompheniramine (Claim 8, 21).
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over MacMillan (US20040029864) in view of Koff (US20110236349) and Cengic et al. (US20080286343).
MacMillan teaches treating colds caused by coronavirus by administering antihistamine brompheniramine (Claim 8, 21).
MacMillan does not teach the coronavirus is SARS or a food composition.
Koff teaches the treatment of viral infection by administering a composition comprising antihistamines including hydroxyzine ([0235]-[0236]) wherein the virus is SARS-CoV (claim 15).
Cengic et al. (US20080286343) pharmaceutical formulations of anti-virals and antihistamines in food form (claims 2, 5-7, [0056], [0059])
One of ordinary skill in the art treating a coronavirus as per MacMillan would have considered applying the antihistamine therapeutic to newer coronavirus, including SARS-CoV as taught by Koff. One of ordinary skill in the art would have also considered known means of formulation antihistamines including as a food composition as taught by Cengic. The level of skill in the art is very high such that one of ordinary skill in the art would have considered routine the optimization of a formulation of a pharmaceutical shown to be clinically effective in feasible formulations and routes of administration including IV, tablets, and food – all of which were well-known and routinely used in the art. Thus, one of ordinary skill in the art would have readily considered including the pharmaceutical in a food composition to treat SARS and arrive at the claimed invention with a reasonable expectation of success. Thus, claims 1-11 are rendered obvious.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combined teachings of the art. Through the combined teachings, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/ Primary Patent Examiner, Art Unit 1626