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 1-18 and 22 are pending in the instant application.
Election/Restrictions
Applicant’s election of Group I,
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and the species of Example 6, disclosed on pages 77-79 of the instant specification (reproduced below),
EXAMPLE 6
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in the reply filed on May 26, 2026 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
NOTE TO APPLICANT:
The elected species of Example 6,
EXAMPLE 6
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is not embraced by instant independent claim 1. See formula I in claim 1,
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, and the definitions of variables Z and Rd {Z = CRd} in independent claim 1, which variable Z is in the 5-position of the dihyro-1H-cyclopropa[b][1]benzofuran ring. Further, it was requested that Applicant indicate how the elected species is embraced by the claims as seen at the top of page 7 of the Restriction requirement dated March 24, 2026 to ensure a proper species election. However, Applicant failed to do so. To advance prosecution, the elected invention of Group I has been searched and examined.
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 26, 2026.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on April 17, 2024 and
June 17, 2025. 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: some of the compounds or substituents in the tables on pages 73, 74 and 80-91 are not completely legible. See, for example, Intermediates IA5-IA7 on page 73; Intermediates IA8 and IA9 on page 74; Compounds A1-A3 on page 80; etc.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: the Preliminary Amendment filed March 5, 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 “each of which is hereby incorporated 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 September 19, 2022. See a partial capture of the BIB sheet of the instant application below.
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Specifically, PCT/US2022/043939 was filed without an “incorporation by reference” statement to the earlier US provisional application. 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 March 5, 2024, which is after the instant application's International filing date of September 19, 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. 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 “each of which is hereby incorporated by reference in its entirety” from the instant specification.
Claim Objections
Claims 1, 10, 13 and 15 are objected to because of the following informalities:
in claim 1, under the definition of variable R3, “is” should be added after “alkoxy” in the phrase “alkoxy substituted” (page 3, line 3 of the page);
in claim 1, under the definition of variable R1, an “or” should be added at the end of this definition because the language which follows is an alternative definition of variable R1 (page 3, line 12 of the page);
in claim 10, “isoxazolyl” is listed twice under the definition of variable A (lines 3 and 5 of the claim);
in claim 10, “benzopyrazolyl” is misspelled under the definition of variable A (line 2 of page 5);
in claim 13, “difluoromethyl” is misspelled (line 3 of the claim);
in claim 13, “methylcarboxy” is misspelled (the last line of the claim); and
in claim 15, the phrase “theyareattached” should be changed to “they are attached”.
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 1-18 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.
Currently amended claim 1 is confusing because there is a definition for variable p but variable p is not found in amended formula I or in any other variable definition. Therefore, the presence of the definition of variable p in claim 1 makes claim 1 indefinite.
Claim 1 is confusing because of the phrase “each X is”. There is only one occurrence of variable X. See claims 2 and 3 for same. Therefore, having “each” in the phrase “each X is” makes claims 1-3 indefinite.
Claim 1 is confusing because of the proviso under the definition of variable X which states “provided that when p is 2 at least one X is CRaRb”. As stated above, variable p is not found in instant formula I or in any other variable definition. See claim 2 and 3 for same. Therefore, claims 1-3 are indefinite.
There is a valence problem raised when variable w represents 4 in instant formula I,
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. There are only three (3) available carbons in which an R3 variable substituent can be attached (note: variable Z represents CRd or N). Therefore, claim 1 is indefinite.
Claim 1 is confusing because of the phrase “each Ra and Rb is”. There is only one occurrence of variable Ra and only one occurrence of variable Rb (see the definition of variable X). See claims 6 and 7 for same. Therefore, having “each” in the phrase “each Ra and Rb is” makes claims 1, 6 and 7 indefinite.
Claim 1 is confusing because of the phrase “where said alkyl or alkoxy substituted with 0, 1, 2, 3, 4, or 5” under the definition of R3. The phrase in claim 1 does not identify the possible substituents on the “alkyl” or “alkoxy”. Therefore, claim 1 is indefinite.
Claim 1 is unclear because it is not possible to have a C1-cycloalkyl or a C2-cycloalkyl as found under the definition of variable A. A minimum of three carbons are required for a cycloalkyl ring. Therefore, claim 1 is indefinite.
Claim 1 is confusing because of the phrase “wherein each R7 independently is substituted” (the 3rd-4th lines from the end of the claim). The R7 variable definition includes hydrogen, halogen and hydroxy. It is not clear how a hydrogen, halogen or an hydroxy can be substituted as stipulated by the phrase “wherein each R7 independently is substituted”. Therefore, claim 1 is indefinite.
Claims dependent on claim 1 but do not resolve the problems in claim 1 as stated above are also found indefinite.
Claim 6 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 that variable Ra or variable Rb can represent (C1-C4)alkylcarbonyl as found in claim 6. Therefore, claim 6 is indefinite.
Claim 8 lacks antecedent basis from claims 1 and 6 because there is no earlier recitation in claims 1 and 6 that the “alkyl” or “alkoxy” under the definition of variable R3 is optionally substituted with 1-5 fluoro as stated in claim 8 (lines 3-4 of the claim). Therefore, claim 8 is indefinite.
In claim 10, it is not clear what is meant by “I-oxo-thiomorpholinyl” under the definition of variable A (see the 3rd line from the end of the claim). Therefore, the metes and bounds of claim 10 cannot be ascertained.
Claim 11 lacks antecedent basis from claim 1, and the claims from which claim 11 depends, because there is no earlier recitation in claim 1 that variable A can represent “hexyl” as found in claim 11 (line 2 of the claim). Therefore, claim 11 is indefinite.
Claim 15 lacks antecedent basis from claim 14 because there is no earlier recitation in claim 14 that R1 and R2 together with the carbon atom to which they are attached join together to form a ring. Therefore, claim 15 is indefinite. This rejection of claim 15 can be overcome by changing the dependency of claim 15 to depend from claim 1.
Claim 16 lacks antecedent basis from claim 1 because there are numerous compounds claimed in claim 16 which are not embraced by currently amended claim 1 due to either amended formula (I),
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, added to claim 1 and the definition of variable X and/or the definition of variable Rd {Z = CRd} in claim 1. See, for instance, the 2nd, 3rd, 4th and 5th compounds claimed in claim 16, which correspond to Example 3 (pages 75-76), Example 4 (page 76), Example 5 (page 77), and Example 6 (pages 77-78), respectively, in the instant specification, all reproduced below.
EXAMPLE 3
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EXAMPLE 6
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.
Therefore, claim 16 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 6-16 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 claim 1 because claim 6 is broader in scope than claim 1. Claim 1 does not state that the Ra variable or the Rb variable can represent (C1-C4)alkylcarbonyl as found in claim 6.
Claims dependent on claim 6 but do not resolve the problem in claim 6 also fail to further limit claim 1.
Claim 8 fails to further limit claims 1 and 6 because claim 8 is broader in scope than claims 1 and 6. Independent claim 1, nor dependent claim 6, state that the “alkyl” or “alkoxy” under the definition of variable R3 is optionally substituted with 1-5 fluoro as stated in claim 8 (lines 3-4 of the claim).
Claim 11 fails to further limit claim 1, and the claims from which claim 11 depends, because claim 11 is broader in scope than claim 1. Claim 1 does not state that A variable can represent “hexyl” as found in claim 11 (line 2 of the claim).
Claim 15 fails to further limit claim 14 because claim 15 is broader in scope than claim 14. Claim 14 does not state that R1 and R2 together with the carbon atom to which they are attached join together to form a ring. This rejection of claim 15 can be overcome by changing the dependency of claim 15 to depend from claim 1.
Claim 16 fails to further limit claim 1 because claim 16 is broader in scope than claim 1. There are numerous compounds claimed in claim 16 which are not embraced by currently amended claim 1 due to either amended formula (I),
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, added to claim 1 and the definition of variable X and/or the definition of variable Rd {Z = CRd} in claim 1. See, for instance, the 2nd, 3rd, 4th and 5th compounds claimed in claim 16, which correspond to Example 3 (pages 75-76), Example 4 (page 76), Example 5 (page 77), and Example 6 (pages 77-78), respectively, in the instant specification.
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 § 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 1-4 and 6-15 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
the compound of Chemical Abstracts Registry Number 2370377-62-9 {indexed in the Registry file on STN CAS ONLINE August 30, 2019},
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{a compound of instant formula I,
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,
when
q = 1;
X = CRaRb, where
Ra = hydrogen, and
Rb = hydrogen;
w = 0;
Z = CRd, where
Rd = hydrogen;
y = 0;
R4 = hydrogen;
R1 and R2 together with the carbon atom to which they are attached join
together to form an unsubstituted ring; and
A = heteroaryl, unsubstituted (i.e., 1,2,4-oxadiazolyl)};
the compound of Chemical Abstracts Registry Number 2369786-97-8 {indexed in the Registry file on STN CAS ONLINE August 29, 2019},
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{a compound of instant formula I,
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,
when
q = 1;
X = CRaRb, where
Ra = hydrogen, and
Rb = hydrogen;
w = 0;
Z = CRd, where
Rd = hydrogen;
y = 0;
R4 = hydrogen;
R1 = hydrogen;
R2 = C1 alkyl; and
A = heteroaryl, substituted with one R7, where
R7 = halogen (i.e., pyridyl substituted with fluoro)};
the compound of Chemical Abstracts Registry Number 2194093-53-1 {indexed in the Registry file on STN CAS ONLINE March 19, 2018},
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{a compound of instant formula I,
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,
when
q = 1;
X = CRaRb, where
Ra = hydrogen, and
Rb = hydrogen;
w = 0;
Z = CRd, where
Rd = hydrogen;
y = 0;
R4 = hydrogen;
R1 = hydrogen;
R2 = hydrogen; and
A = heteroaryl, unsubstituted (i.e., benzofuranyl)}; and
the compound of PubChem CID 154789403 {National Center for Biotechnology Information. PubChem Compound Summary for CID 154789403, 5-bromo-N-(2-methyl-4-pyridinyl)-1,1a,6,6a-tetrahydrocyclopropa[a]indene-1-carboxamide. https://pubchem.ncbi.nlm.nih.gov/compound/154789403. Accessed June 16, 2026, create date November 23, 2020},
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{a compound of instant formula I,
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,
when
q = 0;
X = CRaRb, where
Ra = hydrogen, and
Rb = hydrogen;
w = 1;
Z = CRd, where
Rd = hydrogen;
y = 0;
R3 = halogen (i.e., bromo);
R4 = hydrogen; and
A = heteroaryl, substituted with one R7, where
R7 = C1 alkyl (i.e., pyridyl substituted with methyl)}.
Each of the above cited prior art disclose a compound that is embraced by the instant claimed invention. Further, each of the records for the Chemical Abstracts Registry Numbers disclose the predictability of the compounds in water. Water is a known carrier. See lines 7-10, 14 and 15 on page 31 of the instant specification. Therefore, each of the above cited prior art anticipates the instant claimed invention.
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
June 17, 2026
Book XXIX, page 67
Prosecution Insights