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, 3-15 and 17-22 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 (106), which is disclosed on page 15 of the instant specification,
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in the reply filed on January 20, 2026 is acknowledged.
Applicant’s compound genus of instant formula (I) being administered for the claimed method of use has a number of variables and their permutations and combinations result in a vast number of compounds that are generically claimed. In an initial attempt to examine the full scope of compounds of instant formula (I) found in independent claim 1, over 148,700 Chemical Abstract Registry numbers were recovered in one database search alone.
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Therefore, the compounds of instant formula (I) being administered for the claimed method of use in elected Group I will be examined according to MPEP §803.02.
The claims within the method of use of elected Group I have been examined to the extent that they are readable on the elected the species of Compound (106). Since no prior art was found on the elected species for the instant claimed method of use, the examination was expanded within the compounds of instant formula (I) until prior art was found, in which case, the examination stopped and prior art has been applied against the claims. Note, M.P.E.P. §803.02.
The subject matter of the expanded search and examination thus far, inclusive of the elected species of Compound (106), is as follows:
the claimed method of use of instant independent claim 1 wherein the compound being administered is a compound of instant formula (I),
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wherein
n is 1;
X1 is CR2; and
all other variables are as defined in independent claim 1.
See also formula (II),
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, in dependent claim 5.
Claims embraced by the above identified expanded search and examination are claims 1, 3-15 and 17.
The requirement is still deemed proper and is therefore made FINAL.
Subject matter not embraced by the above identified search and examination and Claims 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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
January 20, 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 Statement filed on April 27, 2023. The submission is in compliance with the provisions of
37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See page 29, lines 30-32, of the instant specification.
The disclosure is objected to because of the following informalities: some of the chemical structures on pages 53, 54 and 58 are not completely legible.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: the Preliminary Amendment filed March 13, 2023 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 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 September 14, 2021. See a partial capture of the BIB sheet of the instant application below.
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.
Specifically, PCT/GB2021/052382 was filed without an “incorporation by reference” statement to the earlier applications filed in the United Kingdom. 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 13, 2023, which is after the instant application's International filing date of
September 14, 2021. 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 “each of which is incorporated herein by reference in its entirety” from the instant specification.
Claim Objections
Claims 1, 5 and 17 are objected to because of the following informalities:
in claim 1, under the definition of variable R8, an “or” should be added before “an optionally substituted 3 to 10 heterocyclyl” (page 4, line 5 of the page);
a period should be added at the end of
claim 5; and
a period should be added at the end of
claim 17.
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, 3-15 and 17 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.
Claim 1 is unclear because line 1 states a method of preventing but then the claim states “a disease treatable”. The disease cannot be prevented if it is already being treated. Therefore, claim 1 is indefinite. This rejection can be overcome by deleting “preventing” from the claim.
Claim 1 is unclear because of the phrase “a pharmaceutically acceptable complex” (see the next to the last line of the claim). It is not clear what is meant by a “complex” of a compound of formula (I). No definition or description of a “complex” is disclosed in the instant specification. Therefore, claim 1 is indefinite because the metes and bounds of the claim cannot be ascertained. This rejection can be overcome by deleting “a pharmaceutically acceptable complex” from independent claim 1.
Claims dependent on claim 1 which do not resolve the problems in claim 1 are also found indefinite.
Claim 11 and Claim 12 each lack antecedent basis from claim 10 because there is no earlier recitation in claim 10 for the R1 variable representing chloro (as found in claim 11) or for R1 representing any of the ring structures listed in claim 11 or in claim 12. Claim 11 depends from claim 10 and Claim 12 depends from claim 11. Claim 10 lists specific multi-substituted aromatic 6-membered ring structures which define the R1 variable. In claim 10, none of the R9-R13 variables can represent hydrogen. Further, claim 10 does not embrace ring structures representing the R1 variable other than the multi-substituted 6-membered aromatic ring structures which may contain one or two nitrogens. Note, for instance, an unsubstituted thienyl, an unsubstituted morpholine, etc. listed in claim 11 under the definition of the R1 variable and an unsubstituted pyridinyl listed in claim 12. Therefore, claims 11 and 12 are each indefinite.
Claim 14 lacks antecedent basis from the claims from which it depends because there is no earlier recitation in independent claim 1 that the R5 aryl or the heteroaryl can be substituted with SR6 as found in claim 14. Therefore, claim 14 is indefinite.
Claim 15 is unclear due to the phrase “optionally wherein R5 is a phenyl substituted with OCF3” (see the last two lines of the claim). An “or” is not found before the phrase which would indicate an alternative definition for the R5 variable nor is the use of “optionally” in the phrase clear. Therefore, claim 15 is indefinite. This rejection can be overcome by the deletion of the phrase “optionally wherein R5 is a phenyl substituted with OCF3” from claim 15.
Claim 17 is confusing because there are two compounds in claim 17 with the same number but having two different chemical structures. Claim 17 states that the compound of formula (I) is a compound of formula (100) to (122). See the two compounds labelled (117) on page 8 (row 5, column 2) and on page 9 (row 1, column 1). Same occurrence is found on page 27 of the instant specification. Therefore, claim 17 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 11, 12 and 14 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 11 and Claim 12 each fail to further limit claim 10 because claims 11 and 12 are each broader in scope than claim 10. Claim 10 lists specific multi-substituted aromatic 6-membered ring structures that may contain one or two nitrogens which define the R1 variable and these rings structures in claim 10 are substituted at every position with one of R9-R13 variables. However, Claim 11 lists an unsubstituted 5-membered sulfur containing ring, chloro, saturated rings, bicyclic rings, oxygen containing rings, 6-membered aromatic rings which are unsubstituted, etc. to define the R1 variable. Claim 12 defines R1 as an unsubstituted pyridine ring.
Claim 14 fails to further limit the claims from which it depends because claim 14 is broader in scope than the claims from which it depends. Claim 14 states that the R5 phenyl or the 5 or 6-membered heteroaryl can be substituted with SR6. However, the claims from which claim 14 depends from have no such substitution possibility.
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, 3-9, 13-15 and 17 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
Bearss et al. {WO 2008/058126 A2} – who disclose that Compound 7-12 (page 81) is a Pim-1 kinase inhibitor which can be administered to a patient for the treatment of diseases and conditions mediated by protein kinases such as cancer {paragraph [0008]-[0009] on page 3; paragraph [0115] on page 31; and paragraph [0127] on page 37},
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{a compound of instant formula (I) or formula (II) in instant dependent claim 5,
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wherein
R1 = halogen (chloro);
n = 1;
X1 = CR2 ;
R2 = hydrogen;
R3 = hydrogen;
R4 = hydrogen;
R5 = substituted C6 aryl,
where aryl is substituted with OR6, and
R6 =substituted C1 alkyl,
(i.e., phenyl substituted with 3-trifluoromethoxy);
-OR –
Compound (112) in instant claim 17};
b) Lau {WO 2017/044623 A1} – who disclose, for instance, Compound 413 in Table 3 (page 112) and that his compounds can be administered to a patient to treat cancer and neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease {paragraph [0002] on page 1 and pages 6-13},
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{a compound of instant formula (I) or formula (II) in instant dependent claim 5,
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wherein
R1 = unsubstituted 6-membered heteroaryl (i.e., pyridin-4-yl);
n = 1;
X1 = CR2 ;
R2 = hydrogen;
R3 = hydrogen;
R4 = hydrogen;
R5 = substituted C6 aryl,
where aryl is substituted with COR6, and
R6 = C1 alkyl,
(i.e., phenyl substituted with 3-acetyl);
-OR –
Compound (122) in instant claim 17}; and
c) Horwitz et al. {WO 2020/047037 A1} – who disclose, for instance, Example 2 (pages 34-35) and that his compounds can be administered to a patient to treat cancer (pages 4, 30 and 31),
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{a compound of instant formula (I) or formula (II) in instant dependent claim 5,
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wherein
R1 = unsubstituted 6-membered heterocycyl (i.e., piperazin-4-yl);
n = 1;
X1 = CR2 ;
R2 = hydrogen;
R3 = hydrogen;
R4 = hydrogen;
R5 = substituted C6 aryl,
where aryl is substituted with CONR6R7,
R6 = hydrogen, and
R7 = hydrogen,
(i.e., phenyl substituted with 4-carboxamido)}.
The instant claimed method of use is directed to a method for treating a disease treatable by inhibiting Lemur tyrosine kinase 3 (LMTK3) in a subject. The instant specification discloses that diseases which can be treated by inhibiting Lemur tyrosine kinase 3 includes a multitude of cancers and neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease (page 5, lines 26-36).
Each of the above cited prior art disclose at least one compound that is embraced by instant formula (I) and instant formula (II) as shown above. Each of the above cited prior art disclose at least one disease which can be treated (such as a cancer) by administering to a patient a therapeutically effective amount of the prior art compound. 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.
Allowable Subject Matter
The elected species of Compound (106) for the claimed method of use is allowable over the prior art of record.
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
March 27, 2026
Book XXIX, page 29
Prosecution Insights