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.
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 the previous Office Action. The requirement was deemed proper and therefore made FINAL in the 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Claims 10-14, 16, 17 and 19 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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.
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.
Specification
The disclosure is objected to because of the following informalities: the Preliminary Amendment filed July 29, 2022 is objected to under
35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “the disclosures of which are incorporated herein by reference in their entireties”.
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(b).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-08.2017]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application.
An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7, a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18, accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a), (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a), a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i), 20.5(b) or 20.5(c), as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b), 20.4, 20.5(a), (b) and (c), and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) or 20.5(a), as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) or a part of the description, claims or drawings referred to in Rule 20.5(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6, incorporated by reference in the international application for the purposes of Rule 20.6. Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of March 26, 2020. See a partial capture of the BIB sheet of the instant application below.
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Specifically, PCT/CN2020/081481 was filed without an “incorporation by reference” statement to the earlier application filed in China. Then, Applicant filed a 371 of the PCT and attempted to amend the specification to include the “incorporation by reference” statement via a Preliminary Amendment filed July 29, 2022, which is after the instant application's International filing date of March 26, 2020. This is considered new matter. MPEP 201.06(c): “An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).”
Further, in Box VI of the PCT request form, R0/101, there is a statement regarding “incorporation by reference” which basically fulfills the written notification regarding “incorporation by reference” when the document is signed. This satisfies the written notice according to Rule 4.18 but does not satisfy the conditions of PCT Rule 20.6 (a)(i)-(iv). In the PCT, Applicant is not required to explicitly state “incorporation by reference” within the PCT Specification (description pages).
However, “incorporation by reference” in the PCT must be verified per PCT Rule 20.6 (a)(i)-(iv) for incorporating specific documents which were inadvertently left out of the PCT disclosure and Applicant has only a limited amount of time to explicitly indicate, during PCT prosecution, what the missing part(s) are and to submit those missing parts into the PCT file. Once they are in the file and if they have complied with PCT Rule 20.6 (a)(i)-(iv), the additional sheets, added by “incorporation by reference” will be stamped “incorporation by reference” by WIPO. Therefore, the entirety of the PCT application, including any missing parts added by “incorporation by reference” in the PCT prosecution will be a part of the National Stage application.
Therefore, the rules and requirements surrounding “incorporation by reference” relating to PCT are different than the “incorporation by reference” in US cases, and even if they did incorporate something by reference in the PCT e.g., a page of the specification from a foreign priority document, this does not provide them “incorporation by reference” to the entire foreign priority document. Therefore, inserting “incorporation by reference” into the disclosure on or after the National Stage US filing date would be new matter. For all the reasons given above, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter.
Response to Arguments
Applicant’s arguments filed January 29, 2026 have been fully considered. Applicant argues that the incorporation by reference statement of the related applications is proper and does not introduce new matter.
In response, the instant application is a 371 application, which has a filing date of March 26, 2020. An incorporation by reference statement was not made to the foreign priority document filed in China on
January 29, 2020 (China 202010077463.3) when the International application was filed on March 26, 2020.
The filing date of the instant application is the International filing date of PCT/CN2020/081481, which is March 26, 2020 (see 35 USC 363).
35 U.S.C. 363 International application designating the United States: Effect.
[Editor Note: Applicable to any patent application subject to the first inventor to file provisions of the AIA (see 35 U.S.C. 100 (note) ). See 35 U.S.C. 363 (pre-AIA ) for the law otherwise applicable.]
An international application designating the United States shall have the effect, from its international filing date under article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.
(Added Nov. 14, 1975, Public Law 94-131, sec. 1, 89 Stat. 686; amended Nov. 8, 1984, Public Law 98-622, sec. 403(a), 98 Stat. 3392; amended Sept. 16, 2011, Public Law 112-29, secs. 20(j) (effective Sept. 16, 2012) and 3(g) (effective March 16, 2013), 125 Stat. 284.)
Any subject matter introduced after the International filing date (such as an Incorporation by reference statement) that is not supported by the original disclosure is new matter.
Applicant’s attention is directed to MPEP §608.04(c), reproduced below.
608.04(c) Review of Examiner’s Holding of New Matter [R-11.2013]
Where the new matter is confined to amendments to the specification, review of the examiner’s requirement for cancelation is by way of petition. But where the alleged new matter is introduced into or affects the claims, thus necessitating their rejection on this ground, the question becomes an appealable one, and should not be considered on petition even though that new matter has been introduced into the specification also. See also MPEP § 2163.06.
The objection to the specification is deemed proper and is therefore maintained.
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 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 1-6 and 18 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by Liu et al. {CN 106928206 A}. A Human assisted English translation of CN 106928206 A was provided with the previous Office Action and will be referred to hereinafter.
Liu et al. disclose Compound 52 on pages 18 and 45 of the provided English translation,
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Liu et al. disclose that his compounds can be administered to treat diseases related to abnormal replication of coronaviruses such as a respiratory tract infection {paragraphs [0103]-[0104] on page 54 of the provided English translation}. See instant claim 2. Compound 52 of Liu et al. is the same compound as the elected species of Compound 48 in the instant application. See 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).
Therefore, Liu et al. anticipate the instant currently claimed invention.
Response to Arguments
Applicant's arguments filed January 29, 2026 have been fully considered. Applicant argues that Liu et al. do not teach or suggest any methods for treating 2019-nCoV infection. Applicant argues that 2019-nCoV had not been discovered until the end of 2019, which is after the filing date of Liu et al., namely the year of 2015. Applicant argues that although both 2019-nCoV and SARS-CoV are both beta-coronaviruses, they are distinct viruses with significant differences. Applicant argues that the inhibitory effect to 2019-nCoV 3CL protease is different from that to SARS-CoV 3CL protease and Applicant provides inhibitory activity of the presently claimed compounds. Applicant argues that, in Liu et al., the compounds for inhibiting SARS-CoV protease possess a phenyl ring at the R1 position.
All of Applicant’s arguments have been considered but have not been found persuasive. Instant independent claim 1 is not directed to a method for treating a 2019-nCoV infection. Instant claim 1 is directed to a method for treatment of a related disease caused by 2019-nCoV infection. See lines 1-2 of instant currently amended independent claim 1 (reproduced below),
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The instant specification defines what is meant by “related disease” caused by 2019-nCoV infection (see page 2, lines 30-33), reproduced below,
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Further, instant dependent claim 2 also claims these 2019-nCoV infection related diseases such as a respiratory tract infection (see instant claim 2 – reproduced below).
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As stated in the above anticipatory rejection, Liu et al. disclose that his compounds can be administered to treat diseases related to abnormal replication of coronaviruses such as a respiratory tract infection {paragraphs [0103]-[0104] on page 54 of the provided English translation}, paragraph [0104] in Liu et al. is reproduced below,
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As identified (and claimed) by Applicant, a “respiratory tract infection” is considered a related disease caused by 2019-nCoV infection. Further, and also stated in the above anticipatory rejection, Liu et al. Compound 52 of Liu et al., which is the same compound as the elected species of Compound 48 in the instant application and as claimed in instant claim 6. A compound and its properties are inseparable. In re Papesch, 137 USPQ 43 (CCPA 1963). See MPEP 2112.01(I) and (II). The same compound (Compound 52 in Liu et al. and instant Compound 48) is being administered to the same mammal (such as a human) to treat the same disease (i.e., a respiratory tract infection caused by coronavirus). Therefore, Applicant’s arguments are not persuasive.
Applicant argues that, in Liu et al., the compounds for inhibiting SARS-CoV protease possess a phenyl ring at the R1 position. In response, Liu et al. disclose a number of compounds in which the R1 position (which corresponds to the R1 position in instant General Formula I in the instant claims) has a saturated ring. 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. For all the reasons given above, the anticipatory rejection is deemed proper and therefore, the anticipatory rejection is maintained.
Note to Applicant: Not every piece of prior art found in the database search or class/subclass search which would anticipate and/or render obvious the instant claimed invention under examination has been applied against the instant currently pending claims under examination. See MPEP §904.03.
The elected species of Compound 48 for the claimed method of use in elected Group I is not allowable. See the above anticipation rejection under 35 USC 102(a)(1) over Liu et al., especially Compound 52, and the methods of treating diseases such as a respiratory tract infection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
February 23, 2026
Book XXVIII, page 193