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
This Office Action is in response to Applicants’ Amendment and Remarks filed on 2/3/2026 in which claims 7 and 8 are amended. No claims are newly added or canceled.
Claims 7-11 are pending 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.
Withdrawn Rejections
Applicant’s amendment, filed on 2/3/2026, with respect to the rejection of claims 7-11 under 35 U.S.C. 112(a), for lack of enablement has been fully considered and is persuasive. Applicant amended the claims to remove references to a method of prevention. The rejection is hereby withdrawn.
Maintained Rejections
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, reference of record).
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 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.
Response to Arguments
Applicants’ arguments with respect to the anticipatory rejection over Dubina, have been fully considered but they are not persuasive.
Applicant argues that the Examiners’ reliance on the inhibition of IL-6 being inherent is misplaced because the cited prior art does not recognize that inosine inhibits IL-6. Applicants’ argument is not persuasive because there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (MPEP § 2112(II)) Proof that inosine inhibits production of IL-6 is provided by Liaudet et al. (Ann. Surg., 2002, PTO-892), where it is disclosed that, “Inosine Downregulates the Expression of TNF-, IL-1 , and IL-6”. (p. 572, Col. 1) Thus, the silence of Dubina in the effect of inosine on IL-6, does not negate the inherent property of inosine in inhibiting IL-6 production when administered to a subject for treating a disease/condition. Applicant further argues that Dubina administers inosine pranobex which is a distinct compound from inosine. Applicants’ argument is not persuasive because the claim scope includes inosine pranobex by reciting “or a drug comprising inosine”.
The rejection is still deemed proper and is maintained.
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, reference of record).
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 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.
Response to Arguments
Applicants’ arguments with respect to the anticipatory rejection over Mitani, have been fully considered but they are not persuasive.
Applicant argues that the Examiners’ reliance on the inhibition of IL-6 being inherent is misplaced because the cited prior art does not recognize that inosine inhibits IL-6. Applicants’ argument is not persuasive because there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (MPEP § 2112(II)) Proof that inosine inhibits production of IL-6 is provided by Liaudet et al. (Ann. Surg., 2002, PTO-892), where it is disclosed that, “Inosine Downregulates the Expression of TNF-, IL-1 , and IL-6”. (p. 572, Col. 1) Thus, the silence of Mitiani in the effect of inosine on IL-6, does not negate the inherent property of inosine in inhibiting IL-6 production when administered to a subject for treating a disease/condition.
The rejection is still deemed proper and is maintained.
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, reference of record).
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 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.
Response to Arguments
Applicants’ arguments with respect to the anticipatory rejection over Iachettini, have been fully considered but they are not persuasive.
Applicant argues that the Examiners’ reliance on the inhibition of IL-6 being inherent is misplaced because the cited prior art does not recognize that inosine inhibits IL-6. Applicants’ argument is not persuasive because there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (MPEP § 2112(II)) Proof that inosine inhibits production of IL-6 is provided by Liaudet et al. (Ann. Surg., 2002, PTO-892), where it is disclosed that, “Inosine Downregulates the Expression of TNF-, IL-1 , and IL-6”. (p. 572, Col. 1) Thus, the silence of Iachettini in the effect of inosine on IL-6, does not negate the inherent property of inosine in inhibiting IL-6 production when administered to a subject for treating a disease/condition.
The rejection is still deemed proper and is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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
