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 18 are pending in the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under
37 CFR 1.114, including the fee set forth in
37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 26, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I,
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and the species of Compound 48, claimed in instant claim 6 and disclosed on page 11 of the instant specification (reproduced below),
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in the reply filed on June 16, 2025 was acknowledged in a previous Office Action. The requirement was deemed proper and therefore made FINAL in a previous Office Action.
Claims 10-14, 16, 17 and 19 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 16, 2025. Claims 10-14, 16, 17 and 19 have been cancelled per the Amendment filed January 29, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 26, 2026 was filed after the mailing date of the final Office Action on February 25, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Rejections and objections made in the previous Office Action that do not appear below have been overcome by Applicant’s amendments to the claims. Therefore, arguments pertaining to these rejections and objections will not be addressed.
As a result of the current amendments to the claims per the Amendment filed May 26, 2026, the following apply.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
in claim 1, line 1 of the claim, “the” should be added after the phrase “A method for”;
in claim 1, the phrase “which comprising the step of administering” should be changed to “which comprises the step of administering” (line 2 of the claim);
in claim 1, the phrase “R3 is a selected from” should be changed to “R3 is selected from”; and
in claim 6, the period after Compound 88 should be moved to the end of the claim (outside of the table).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 18 are rejected under
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
No persuasive support is found in the originally filed specification or the originally filed claims for the method for treatment as currently claimed in independent claim 1. The instant claims are currently directed to “A method for treatment of a 2019-nCoV infection”. However, the originally filed specification and the originally filed claims disclose, and claim, “A method for treatment of a related disease caused by a 2019-nCoV infection”.
On page 20 of the Remarks section filed
May 26 2026, Applicant states support can be found for the current amendment to claim 1 at least in original claim 1. Original claim 1 is reproduced in-part below,
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Original claim 1 does not claim “A method for treatment of a 2019-nCoV infection”. Applicant should specifically point out the support in the original disclosure {page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. See MPEP §714.02 and MPEP §2163.06(I). Therefore, the currently amended claimed invention lacks written description as such.
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 1-6 and 18 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.
In claim 1, a valence problem is raised when the heterocyclyl or heteroaryl which define the R2 variable is substituted with a sulfonyl. A sulfonyl is a divalent moiety but a monovalent moiety is expected as a substituent. Therefore, claim 1 is indefinite because the metes and bounds of the claim cannot be ascertained.
Claims dependent on claim 1 which do not resolve the problem in claim 1 are also found indefinite.
Claim 6 lacks antecedent basis from currently amended claim 1 because there is no earlier recitation in claim 1 for the R3 substituent representing a substituted alkyl as found in Compound 7 in claim 6 or that the R2 variable can represent a styryl as found in Compound 80 in claim 6. Therefore, claim 6 is indefinite.
Claim 18 lacks antecedent basis from currently amended claim 1 because there is no earlier recitation in claim 1 for the R2 variable representing phenyl or styryl as found in claim 18. Therefore, claim 18 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 6 and 18 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 6 fails to further limit currently amended claim 1 because claim 6 is broader in scope than claim 1. Currently amended claim 1 does not state that the R3 variable can represent a substituted alkyl as found in Compound 7 in claim 6 or that the R2 variable can represent a styryl as found in Compound 80 in claim 6.
Claim 18 fails to further limit currently amended claim 1 because claim 18 is broader in scope than claim 1. Currently amended claim 1 does not state that the R2 variable can represent a phenyl or a styryl as found in claim 18 (lines 2 and 3 of the claim).
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.
Response to Amendment
The Declaration under 37 CFR 1.132 filed
May 26, 2026 is insufficient to overcome the rejection of claims 1-6 and 18 based upon any prior art rejection over Liu et al. {CN 106928206 A} because: Liu et al. teach treating coronavirus, broadly, as well as teach treating coronavirus infection related diseases. Liu et al. disclose a number of his aldehyde compounds which anticipate the genus of compounds of instant General Formula I in the instant claims. See in the provided English translation of Liu et al., for instance, Compounds 34, 35, 43 and 44 (page 16), Compounds 45, 47, 48, 50 and 51 (page 17), Compounds 52-56 (page 18), etc. Further, Liu et al. disclose Compound 52 which is the same compound as the elected species of Compound 48 in the instant application. A compound and its properties are inseparable. In re Papesch, 137 USPQ 43 (CCPA 1963). See MPEP §2112.01(I) and (II). Additionally, the showing is not commensurate in scope with the instant claims. In re Greenfield, 197 U.S.P.Q. 227 (1978) and In re Lindner, 173 U.S.P.Q. 356 (1972). Also see MPEP §716.02(d). To establish unexpected, beneficial and superior results of the instant claimed compounds over the closest prior art compounds (i.e., the multiple anticipatory aldehyde compounds disclosed in Liu et al.), Applicant should compare by testing a sufficient number of exemplified prior art compounds with the compounds of the instant claimed invention. For all the reasons given above, the Declaration under 37 CFR 1.132 filed May 26, 2026 is not persuasive.
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 (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 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, 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 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 1-6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. {CN 106928206 A}. A Human assisted English translation of CN 106928206 A to Liu et al. was provided with a previous Office Action and will be referred to hereinafter.
Determination of the scope and content of the prior art (MPEP §2141.01)
Applicant currently claims a method for treatment of a 2019-nCoV infection, which comprises administering an aldehyde compound according to General Formula I to a subject in need thereof,
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Applicant discloses in the instant specification that “The 2019-nCoV coronavirus belongs to the genus Coronavirus of the Coronavirus family” (page 1, lines 23-24 of the instant specification).
Liu et al. teach aldehyde compounds of formula (I),
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which serve as coronavirus protease inhibitors, and specifically, 3C protease inhibitors {see paragraph [0001] on page 25; paragraphs [0008]-[0020] on pages 27-30; paragraphs [0050]-[0059] on pages 34-36; and paragraphs [0101]-[0104] on pages 53-54 of the provided English translation of Liu et al.}.
Liu et al. disclose many aldehyde compounds which can be administered to treat abnormal replication of coronaviruses. A multiple number of the aldehyde compounds disclosed in Liu et al. are embraced by, and would anticipate, the compounds in instant General Formula I of the present invention. See in the provided English translation of Liu et al., for instance, Compounds 34, 35, 43 and 44 (page 16), Compounds 45, 47, 48, 50 and 51 (page 17), Compounds 52-56 (page 18), etc. Additionally, Liu et al. disclose Compound 52 on pages 18 and 45 of the provided English translation,
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Compound 52 of Liu et al. is the same compound as the elected species of Compound 48 in the instant application. See Compound 48 in instant claim 6. Compound 52 of Liu et al. is embraced by a compound of instant General Formula I in instant independent claim 1,
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when
the chiral carbon atoms C*, C*2 and C*3 are each in
the S configuration;
n is zero;
R1 = unsubstituted C6 cycloalkyl
(i.e., cyclohexyl); and
R2 = unsubstituted 9-membered heteroaryl
(i.e., indol-2-yl).
Liu et al. teach that his aldehyde compounds can be administered to mammals, including humans and animals, to treat diseases related to abnormal replication of coronaviruses such as a respiratory tract infection {paragraphs [0103]-[0104] on page 54; and paragraphs [0115]-[0116] on pages 57-58 of the provided English translation}. Paragraphs [0104] and [0016] in Liu et al. are reproduced below,
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See instant currently amended claim 2.
Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02)
The difference between the method of treating taught by Liu et al. and the instant claimed method for treatment is that Liu et al. do not specifically teach a method for treatment of a 2019-nCoV infection as instantly claimed.
Finding of prima facie obviousness--rational and motivation
(MPEP §2142-2143)
However, Liu et al. teach treating coronavirus and diseases related to a coronavirus infection such as a respiratory tract infection. One of ordinary skill in the art would have found it obvious to treat a 2019-nCoV infection with an aldehyde compound of Liu et al. since Liu et al. teach that his aldehyde compounds are 3C protease inhibitors which are an effective treatment for coronavirus and diseases related to a coronavirus infection. Given the teachings of Liu et al., one of ordinary skill in the art would have been motivated to administer the aldehyde compounds of Liu et al. to treat a 2019-nCoV infection with the reasonable expectation of success in providing a method that is not only effective in inhibiting 3C proteases but also effective in treating various diseases related to a coronavirus infection such as a respiratory tract infection. The instant claimed invention would have been suggested to one of ordinary skill in the art and therefore, the instant claimed invention would have been obvious to one of ordinary skill in the art.
The elected species of Compound 48 for the currently claimed method of use is not allowable. See the above rejection under 35 USC 103 over Liu et al., especially Compound 52, and the methods of treating abnormal replication of coronaviruses.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. 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
June 18, 2026
Book XXVIII, page 193
Prosecution Insights