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 .
Priority
This application is a National Stage entry under 35 U.S.C. § 371 of PCT/JP2021/003756, filed on February 2, 2021.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on August 1, 2023 (16 references) has been received entered into the present application, in compliance with the provisions of 37CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
Status of the Claims
Claims 1-8 are pending and are the subject of the Office Action below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends because the claims do not further limit claim 1 that requires an antiviral agent comprising a xanthine oxidase inhibitor in combination with an active oxygen scavenger. Claims 4 and 5 require the antiviral agent which is an antiviral agent composition comprising a xanthine oxidase inhibitor and an active oxygen scavenger (as in claim 4) and the antiviral agent according to any one of claim l which is a combination of a composition comprising a xanthine oxidase inhibitor with a composition comprising an active oxygen scavenger (as in claim5). The applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takaaki, et.al., Dependence on 02- Generation by Xanthine Oxidase of Pathogenesis of Influenza Virus Infection in Mice, J Clin Invest. 1990; 85 (3): 739-745.
Claims 1- 5 and 7 are drawn to an antiviral agent comprising a xanthine oxidase inhibitor in combination with an active oxygen scavenger (as in claim 1), antiviral agent according to claim 1, wherein the xanthine oxidase inhibitor is one or more members at least one selected from the group consisting of Allopurinol, Febuxostat, and Topiroxostat (as in claim 2), the antiviral agent according to claim 1wherein the active oxygen scavenger is one or more members at least one selected from the group consisting of a reduced-form thiol agent, ascorbic acid or a derivative thereof, a tocopherol, an astaxanthine, and a flavonoid (as in claim 3), the antiviral agent according to claim 1 which is an antiviral agent composition comprising a xanthine oxidase inhibitor and an active oxygen scavenger (as in claim 4) , the antiviral agent according to claim 1 which is a combination of a composition comprising a xanthine oxidase inhibitor with a composition comprising an active oxygen scavenger (as in claim 5) and a combination, comprising a xanthine oxidase inhibitor and an active oxygen scavenger, wherein the combination is suitable for treating a viral infectious disease (as in claim 7).
Takaaki details the evaluation of various biochemical parameters in influenza
virus-infected mice focusing on adenosine catabolism in the supernatant of bronchoalveolar lavage fluid (s-BALF), lung tissue, and serum (plasma). They teach that the activities of adenosine deaminase (ADA) and xanthine oxidase (XO), which generates O2- were elevated in the s-BALF, lung tissue homogenate, and serum (plasma) of mice infected with influenza. Further:
“We also identified O2- generation from XO in s-BALF obtained on days 6 and 8 after infection, and the generation of O2- was enhanced remarkably in the presence of adenosine. Lastly, treatment with allopurinol (an inhibitor of XO) and with chemically modified superoxide dismutase (a scavenger of O2-) improved the survival rate of influenza virus-infected mice.”
Takaaki, Abstract, pg. 739 (emphasis added).
Takaaki teaches the use of xanthine oxidase inhibitor used in combination with an active oxygen scavenger to treat mice infected with an influenza virus and shows an improved survival rate of the influenza virus-infected mice that anticipates the instant claims.
Claims 6 and 8 are drawn to methods for producing an antiviral agent comprising combining a xanthine oxidase inhibitor in combination with an active oxygen scavenger (as in claim 6) and a method for preventing or treating a viral infectious disease, comprising:
administering to a subject in need thereof a xanthine oxidase inhibitor in combination
with an active oxygen scavenger (as in claim 8).
As stated in the rejection to claims 1- 5 and 7 above, Takaaki teaches the use a of xanthine oxidase inhibitor used in combination with an active oxygen scavenger to treat mice infected with an influenza virus and shows an improved survival rate of the influenza virus-infected mice and clearly uses both a method of producing and a method of administration of both that anticipates the instant claims.
Conclusion
Claims 1-8 are rejected.
No claims are allowed.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629