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
Filing Receipt and Priority
The filing receipt mailed 07/06/2023 states that the instant application is a 371 of PCT/AU2021/050515, filed 05/27/2021. The filing receipt also states that the applications claims foreign benefit of
Information Disclosure Statement
The information disclosure statements submitted 05/20/2024 and 11/22/2022 have been considered.
Restriction/Species Election
Applicant’s election of the following has been acknowledged. Applicant has elected (1) cysteine or a derivative thereof (glutathione precursor), (2) Betacoronavirus, (3) COVID-19, and (4) Zinc, zinc gluconate, or a derivative.
At examiner’s discretion, examination has been broadened to include pneumonia and acute respiratory distress syndrome (ARDS).
Claim 38 is withdrawn being drawn to a non-elected species.
Rejections
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.
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, 5, 8, 10, 12-13, 15, 21-22, 27, 35-36, 38, 42, 49 and 53-56 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of a condition or disease associated with a coronavirus infection in a subject, does not reasonably provide enablement for prevention of a condition or disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
General “subject”
Claim 1 simply states “A method of preventing, treating and/or reducing the severity of a condition or diseases…in a subject…”. It is not clear from the claim whether the subject has or does not have the condition or disease in need of treatment. The specification in para. [0048] defines “subject” as “human or animal organism” and “includes persons with no defined illness who are being investigated for signs of pathology, as well as subject who have an existing diagnosis of a particular viral disease…”. Therefore, the term “subject” includes persons who have not received a diagnosis of either pneumonia or COVID-19 disease. The claim does not make it explicit that the subject has the condition or disease.
Condition or disease “associated” with COVID-19
Claim 1 states “…a condition or disease associated with a coronavirus infection”.
The instant specification does not define “condition or disease associated with a coronavirus infection”. A non-exhaustive listing of conditions and/or diseases is found in the specification para. [0013]. However, this listing is non-limiting. The term “associated” is indefinite because it is not clear whether the condition or disease is caused by the coronavirus infection directly or if the condition or disease is its own separate infection occurring prior, during, or after a coronavirus infection.
As claims 2, 5, 8, 10, 12-13, 15, 21-22, 27, 35-36, 42, and 53-56 are dependent on claim 1, they are also rejected.
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.
Claim(s) 1-2, 5, 8, 10, 12-13, 15, 27, 35-36, 42 49, and 53 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Horowitz (Respiratory Medicine Case Reports 30, 2020, 101063, published online 04/21/2020).
Regarding claims 1-2, 5, 10, 12-13, 15, 27, 35-36, 42, 49, 53, Horowitz on p. 4, sec. Case History 2 discloses administration of 1200 mg N-acetyl-cysteine to a patient suffering from “Suspected 2019 Novel Coronavirus Infection and Atypical Pneumonia”. Included within this treatment was 50 mg of zinc.
Regarding claims 8 and 27, Horowitz on p. 2, right col., para. 4 discloses that “NAC demonstrated that patients with ARDS have depressed plasma and red cell glutathione concentrations” that are “substantially increased by therapy with intravenous NAC…”.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-2, 5, 8, 10, 12, 13, 15, 21-22, 27, 35-36, 42, 49, 53-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horowitz (Respiratory Medicine Case Reports 30, 2020, 101063, published online 04/21/2020.
Discussion of Horowitz from the 102 rejection above is incorporated here.
Regarding claims 21, 22, and 54-56, while Horowitz does not explicitly disclose dose amounts in specific time periods, one of ordinary skill in the art would find these claims obvious as altering the dose (concentration, amount, time period, etc.) are within the skillset of one of ordinary skill in the art. The MPEP section 2144.05 states:
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to modify the treatment disclosed in Horowitz to embrace the instant claims. One of ordinary skill would find motivation to make the modifications to the method in efforts to best treat a patient suffering from condition or disease.
Conclusion
No claims allowed.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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