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
Pursuant to the preliminary amendment dated 7/7/2023, claims 1-6 are cancelled and claims 7-11 are newly added.
Claims 7-11 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/CN2022/078715, filed on 3/2/2022. The instant application claims foreign priority to Cn 202111541575.0 filed on 12/16/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 7/7/2023.
Information Disclosure Statement
The information disclosure statement (IDS) dated 7/7/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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 7-11 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for treating COVID-19, does not reasonably provide enablement for preventing COVID-19. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
With respect to the claimed invention, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered and those most relevant to the cited claims are discussed below. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. Nature of the invention: The rejected invention is drawn to a method of treating or preventing COVID-19 by using inosine or a drug comprising inosine. Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims: The claims are broad with respect to the concepts of prevention. The specification does not define prevention. Thus, the term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002, PTO-892) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. The full scope of the claims encompasses the entire definition of tertiary prevention, which as defined above covers reducing the occurrence of or eliminating a symptom or condition. Thus, the intent of the claimed invention, would include that which reduces the occurrence of, or eliminates COVID-19.
Amount of guidance/Existence of working examples: There are no working examples demonstrating elimination of COVID-19.
Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed compositions to both healthy individuals and individuals having COVID-19, to determine if the claimed method can be used in the fully claimed scope to treat and prevent obesity. Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success.
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 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubina et al. (Pathogens, 2020, PTO-892).
Dubina et al. discloses a method for treating SARS-CoV-2 infection by administering inosine pranobex (“IP”, 500 mg tablets), where it was observed that fatality rate was reduced for subjects administered IP versus those not administered IP. (Abstract; p. 8, 1-2¶; Sec. 4.2)
With respect to claim 8, and the limitation regarding the effect on IL-6 secretion, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. Because the prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
With respect to claim 9, one of ordinary skill in the art recognizes reduced fatality rate as equivalent to “increasing percent survival”.
Accordingly, the instant claims are anticipated by the prior art.
Claims 7, 8, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitani et al. (WO 2021201224A1, Oct 2021, IDS and English translation, PTO-892).
Mitani et al. discloses a method for treating COVID-19 by orally administering a composition comprising: A) a xanthine oxidase / xanthine dehydrogenase inhibitor, exemplified as febuxostat; and B) hypoxanthine, or a compound that can be converted to hypoxanthine in the body, exemplified as inosine. (Claim 7-10 and 12; Pharm. Ex. 1) Mitani also discloses that oral administration may include formulations such as, injection, capsule, tablet, granule, powder, pill, fine granule, oily suppository or aqueous suppository. (p. 7, 4¶)
With respect to claim 8, and the limitation regarding the effect on IL-6 secretion, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. Because the prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Accordingly, the instant claims are anticipated by the prior art.
Claims 7, 8, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Iachettini et al. (WO 2022/003531A1, pub. Jan 2022, filed June 2021; US 2023/0330126A1 used as equivalent, IDS).
Iachettini et al. discloses a method for treating COVID-19 by administering a tablet or injection composition comprising 3-deoxyadenosine and an agonist of the adenosine receptors A2a and/or A2b, exemplified as inosine. (Claims 11, 13, 14 and 17; Examples 1-7)
With respect to claim 8, and the limitation regarding the effect on IL-6 secretion, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. Because the prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Accordingly, the instant claims are anticipated by the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693