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 1-14 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 1, disclosed on page 23 of the instant specification (reproduced below),
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in the reply filed on August 27, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 27, 2026.
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 Statements filed on June 14, 2024 and
August 27, 2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the Preliminary Amendment filed September 16, 2024 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 phrase “the disclosure of which is incorporated herein by reference in its entirety”.
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 December 1, 2022. See a partial capture of the BIB sheet of the instant application below.
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Specifically, PCT/CN2022/135894 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 September 16, 2024, which is after the instant application's International filing date of
December 1, 2022. 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.
Applicant is required to cancel the new matter in the reply to this Office Action.
This objection to the specification can be overcome by deleting the phrase ““the disclosure of which is incorporated herein by reference in its entirety” from the instant specification.
Claim Objections
Claims 3 and 11 are objected to because of the following informalities:
in claim 3, the table containing Formulae (II), (III), Formula (IV) and Formula (V) is not completely legible since there is text cut-off on the right hand side of each formula;
in claim 3, the period after Formula (V) in the table should be moved to the end of the claim (i.e., outside of the table);
in claim 11, an “and” should be added after compound 107 for proper Markush language format; and
in claim 11, the period after compound 108 should be moved to the end of the claim (i.e., outside of the table).
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.
Claims 1-12 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.
Claims 1-12 are indefinite because the claim is directed to a metabolite of a compound of Formula (I). The instant specification on page 14, lines 2-9, defines a “metabolite” as a substance formed in vivo upon administration of the compound of the present invention. The definition of metabolite also states that “such a product may result e.g., from oxidation, reduction, hydrolysis, amidation, de-amidation, esterification, enzymolysis, and the like”. One skilled in the art would not know the chemical structure of something (i.e., a compound) that is formed in vivo. Therefore, the metes and bounds of claims 1-12 cannot be ascertained. This rejection can be overcome by deleting “metabolite”, all occurrences, from the claims.
Regarding claims 1-5, 7-10 and 12, the phrases “preferably”, "for example", “most preferably”, and “more preferably”, all occurrences, renders the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP §2173.05(d). This rejection can be overcome by deleting the phrases which begin with “preferably”, "for example", “most preferably”, and “more preferably”, all occurrences, from the claims.
Claim 6 is confusing because there are two separate definitions for variables R6 and R7 in the claim. See lines 3-5 of claim 6 and lines 6-7 of claim 6. Therefore, claim 6 is indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Trzoss et al. {WO 2022/225934 A1}.
Trzoss et al. disclose, for instance, Compound 133 on page 74 and the compound on page 82, column 1, row 6,
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{a compound of instant Formula (I) or a metabolite thereof,
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wherein
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is a single bond;
X = N;
Y = CR5, where R5 = hydrogen;
Z = N;
V = NRA, where
RA =
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, where
Ring A is a 6-membered heteroaromatic ring (i.e., pyridinyl),
n is 1,
R4 = -NRa-C(=O)Rb,
Ra = hydrogen, and
Rb = C1 alkyl;
R = hydrogen;
R’ = hydrogen;
R1 = C1 haloalkyl;
R2 = C1 alkyl;
and
m = zero};
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{a compound of instant Formula (I) or a metabolite thereof,
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wherein
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is a single bond;
X = N;
Y = CR5, where R5 = hydrogen;
Z = N;
V = NRA, where
RA =
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, where
Ring A is a 6-membered heteroaromatic ring (i.e., pyridinyl),
n is 1,
R4 = -NRa-C(=O)Rb,
Ra = hydrogen, and
Rb = C1 alkyl;
R = hydrogen;
R’ = hydrogen;
R1 = C2 alkyl;
R2 = halogen (i.e., chloro);
and
m = zero}.
Further, Trzoss et al. disclose pharmaceutical compositions comprising his compounds together with pharmaceutically acceptable carriers {paragraph [00266] on page 97}. Therefore, Trzoss et al. anticipate the instant claimed invention.
A metabolite of the elected species of Compound 1, disclosed on page 23 of the instant specification, is not allowable. See the compounds disclosed in Trzoss et al.
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.
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 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
September 28, 2026
Book XXIX, page 115
