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
Claims 1-6 and 8-14 are pending in the instant application.
Election/Restrictions
Applicant’s election of the species PR-619,
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,
without traverse in the reply filed on August 28, 2025 is acknowledged.
The elected species is embraced by formula I,
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in instant claim 2 when R1 and R2 each represents -NH2. Therefore, inhibitors embraced by formula I for the instant claimed method of use will be searched and examined in the instant application. The status identifiers for claims 2 and 3 should be corrected since these claims are not “(Withdrawn)” as indicated.
The requirement is still deemed proper and is therefore made FINAL.
Inhibitors not embraced by formula (I) and Claims 4-6 and 8-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 28, 2025.
It is suggested that in order to advance prosecution, the non-elected subject matter in which rejoinder is not applicable be canceled if Applicant files a response to this Office Action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement filed on August 26, 2022. The submission is in compliance with the provisions of
37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: in claim 2, an “and” should be added before the definition of R3 and R4.
Appropriate correction is required.
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.
Claim 2 is 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.
Claim 2 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 that the inhibitor is selected from a genus of compounds of formula I as found in claim 2. Therefore, claim 2 is indefinite.
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 2 and 3 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.
Claim 2 fails to further limit independent claim 1 because claim 2 is broader in scope than claim 1. In claim 1, the inhibitor is specifically PR-619 whereas claim 2 is claiming a genus of inhibitors.
Claim 3 fails to further limit claim 1 because claim 3 recites the same inhibitor for the claimed method of use as found in claim 1.
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 § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of teachings in Schubert et al. {US 2017/0202814}, Altun et al. {Chemistry & Biology, 18, 1401-1412, November 23, 2011} and Ioannidis et al. {WO 2016/126929 A1}.
Determination of the scope and content of the prior art (MPEP §2141.01)
Applicant claims a method of treating an individual having a SARS-CoV-2 infection by administering a pharmaceutically effective amount of an inhibitor of human deubiquitinases USP7 and/or USP47, wherein the inhibitor is PR-619,
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{2,6,-diaminopyridine-3,5-bis(thiocyanate)}.
Schubert et al. teach compounds of formula (I),
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wherein
R1 and R2 each independently can represent hydrogen, hydroxy, -NH2, etc. {page 2, paragraphs [0034]-[0040]}. Schubert et al. {pages 2-3, paragraph [0040] and [0044]} disclose that the compound, PR-619,
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is a DUB inhibitor and inhibits USP7, USP47, etc. {page 3, paragraph [0044]},
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Altun et al. teach the in vitro DUB inhibition profiles of DUB inhibitor, PR-619, in Figure 1 on page 1402,
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Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02)
The difference between the instant claimed invention and Schubert et al. is that Schubert et al. do not teach that his compounds can be administered to treat SARS-CoV-2.
The difference between the instant claimed invention and Altun et al. is that Altun et al. do not specifically state that DUB inhibitor PR-619 can be administered to treat SARS-CoV-2 although Altun et al. show the inhibition profile of DUB inhibitor PR-619 using PLpro SARS-Co virus papain-like protease.
Finding of prima facie obviousness--rational and motivation
(MPEP §2142-2143)
However, Ioannidis et al. teach a nexus between inhibitors of ubiquitin-specific protease 7 (USP7) and the treatment of diseases or disorders such as SARS coronavirus infection. See paragraph [0002] on page 1 and paragraph [00161] on page 75.
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the instant claimed invention, to use compound PR-619 to treat a SARS-CoV-2 infection in an individual because Schubert et al. teach that compound PR-619 is a DUB inhibitor that inhibits USP7, Altun et al. show in vitro enzyme activity of the compound PR-619 with PLpro, SARS-Co virus papain-like protease and Ioannidis et al. teach the use of USP7 inhibitors in the treatment of SARS. Therefore, the combination of teachings in Schubert et al., Altun et al. and Ioannidis et al. render obvious the instant claimed invention.
The elected species of Compound PR-619 for the claimed method of use is not allowable.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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,
Joseph K. McKane can be reached on 571/272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
October 18, 2025
Book XXVIII, page 213