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 .
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.
Election/Restrictions
Applicant’s election of “tauroursodeoxycholic acid (TUDCA)” as a species of “hydrophilic bile acid” and “coronavirus that is not SARS-CoV-2 or SARS-CoV-1” as a species of “viral infection”, in the reply filed on 15 September 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants did not provide a species of “viral infection” other than by defining it by what it is not—"a coronavirus that is not SARS-CoV-2 or SARS-CoV-1”. Therefore, Examiner reviewed the prior art for any “coronavirus” being treated with TUDCA in the method of instant claim 1.
Examiner did not find any prior art for Applicants’ elected species: “coronavirus” and “TUDCA” as per method of instant claim 1.
Examiner extended the Markush search to: TUDCA (species of “hydrophilic bile acid”) and “hepatitis B” viral infection as a species of “viral infection”. This search retrieved prior art.
Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species of “viral infections” and “hydrophilic bile acid” in this Office Action.
Claims 1-2 and 4-11 read on the Markush search extension of “TUDCA” being used to treat “Hepatitis B viral infection”, above.
Claims 3, 12-13, and 15-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 September 2025.
Current Status of 17/998,562
This Office Action is responsive to the amended claims of 15 September 2025.
Claims 1-2 and 4-11 have been examined on the merits. Claim 1 is previously presented. Claims 2 and 4-11 are original.
Priority
The effective filing date is 14 May 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 13 June 2025; and 5 January 2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 1-2 and 4-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
LI (U.S. 2017/0266206 A1, referenced in IDS of 5 January 2023).
The prior art reference LI teaches a method of treating a hepatitis B viral (HBV) infection (“Abstract”; see also para [0004] and [0001]) in a subject in need thereof comprising administering to the subject a therapeutically effective amount of TUDCA (the “hydrophilic bile acid”) (para [0026], [0085], [0088]; and examples of compounds in Table A). This anticipates instant claims 1-2.
Furthermore, LI teaches that the TUDCA bile acid can be administered orally, parenterally, and/or via inhalation (see para [0084]). This anticipates instant claims 4-6.
LI teaches preferred dosing from 10 mg to 1000 mg/day (para [0086]). This falls in line with “up to 5 g/day” hence anticipating instant claim 7.
LI also teaches administration twice per day (“preferably two divided doses”-see para [0086]), thereby anticipating instant claim 8.
Moreover, LI at least inherently anticipates instant claims 9-11: it is logical to assume that “treating” HBV would result in a reduction in the viral load of HBV as compared to baseline, which anticipates instant claim 9 since any worthless treatment would not be the subject of patent application (any reduction in viral load, even a small reduction, constitutes an “improvement”). As viral load decreases, symptoms of the infection are expected to improve. This anticipates instant claim 10. This should also result in an improvement in the subject’s clinical status. This anticipates instant claim 11.
Conclusion
No claims are presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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