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 .
Claims 1-20 are pending in the instant application. Claims 1-13 are rejected. Claims 14-20 are allowed.
Information Disclosure Statement
The information disclosure statement filed on December 8, 2023 has been considered and a signed copy of form 1449 is enclosed herewith.
Drawings
The drawings are objected to because the font on some of the figures (i.e., Fig 4e and 4f) is difficult to read or is illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-13, in the response filed on May 8, 2026 is acknowledged. Upon further search and consideration, however, the restriction requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1-20 has been searched and examined in its entirety).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, claims 1-13 are drawn to a compound, daurichromenic acid, or a salt or hydrate thereof, for use in the treatment or prevention of a disease caused by a beta coronavirus, but since the claims do not set forth any steps involved in the treatment or prevention, it is unclear what Applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Regarding claims 2 and 12, the word "including" renders the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome, for example, by deleting the phrases “including SARS-CoV-2, COVID-19” and “including nasogastric” from the claims.
Regarding claim 8, the term “substantially pure enantiomer” is a relative term which renders the claim indefinite. Specifically, the word “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This rejection can be overcome by amending the claim to include the more specific limitation disclosed in claim 9.
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 1-5, 10, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2004/058738 A1.
WO 2004/058738 A1 discloses daurichromenic acid (1a) and pharmaceutical compositions thereof which are used to inhibit HIV growth in vitro or in vivo. See page 8, lines 4-13.
With respect to the art rejection above, it is noted that the reference does not teach that the compound can be used in the manner instantly claimed (i.e., to treat or prevent a disease caused by a beta coronavirus). However, the intended use of the claimed compound does not patentably distinguish the compound, per se, since such disclosed use is inherent in the reference compound. In order to be limiting, the intended use must create a structural difference between the claimed compound and the prior art compound. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Allowable Subject Matter
Claims 14-20 are allowed. No prior art was found.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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