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 1-10 are pending in the application. Claims 3, 4 and 6-10 are rejected. Claims 1-4 and 6-10 are objected to. Claim 5 is withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of the 6-substituted chiral pure difluoropiperidine quinazoline derivative species corresponding to Formula (I), wherein R is Boc, in the reply filed on July 6, 2026 is acknowledged. The absence of any statement indicating whether the requirement to restrict is traversed or the failure to provide reasons for traverse will be treated as an election without traverse. See MPEP § 818.01.
Claims 1-4 and 6-10 read on the elected species. Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 6, 2026.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2023/091927, filed on April 30, 2023, which claims priority to Chinese Application No. CN202210859828.7, filed on July 21, 2022.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on January 31, 2024 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Specification
The amendment filed on January 25, 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 contents of the applications 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 April 30, 2023.
Specifically, PCT/CN2023/091927 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 January 25, 2024, which is after the instant application's International filing date of April 30, 2023. 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)).”
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 contents of the applications are incorporated herein by reference in their entireties” from the instant specification.
Claim Objections
Claim 1-4 and 6-10 are objected to because of the following informalities:
Claim 1 should be amended to replace “comprises a step of quinazoline ring closing:” with “comprises a step of quinazoline ring closing, wherein” for sake of clarity.
Claims 2-4 and 6-10 should each be amended to recite, “The preparation method for the 6-substituted chiral pure difluoropiperidine quinazoline derivative...” for sake of clarity and consistency.
Claim 3 should be amended to include the word “and” before “the equivalent ratio” for sake of clarity.
Claim 4 should be amended to replace “a 2-amino-benzonitrile derivative” with “the 2-amino-benzonitrile derivative” for sake of clarity and consistency.
Claim 8 should be amended to replace “3,3-difluopiperidinol derivative” with “the substituted chiral difluoropiperidinol” for sake of clarity and consistency.
Claim 9 should be amended to replace “3,3-difluopiperidinol derivative” with “the substituted chiral difluoropiperidinol” for sake of clarity and consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3, 4 and 6-10 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 3 recites the following limitations and are rejected as indefinite: “the reaction temperature,” “the reaction time” and “the equivalent ratio of the 2-amino-benzonitrile derivative to (E)-N,N’-bisphenylformamide derivative.” There is insufficient antecedent basis for each of these limitations in the claim. In addition, parent claim 1 from which claim 3 depends therefrom also does not provide for the aforementioned limitations. It is suggested Applicant replace the word “the” with the word “a” or “an” in “the reaction temperature,” “the reaction time” and “the equivalent ratio of the 2-amino-benzonitrile derivative to (E)-N,N’-bisphenylformamide derivative” to overcome this issue of indefiniteness.
Claim 4 recites the limitation “the preparation” and is rejected as indefinite. See line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. In addition, parent claim 1 from which claim 4 depends therefrom also does not provide for the aforementioned limitation. Applicant may overcome this issue of indefiniteness by replacing “the preparation” with “a preparation.”
Claim 4 recites the limitation “The substituted chiral difluoropiperidinol” and is rejected as indefinite. See line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. In addition, parent claim 1 from which claim 4 depends therefrom also does not provide for the aforementioned limitation. Applicant may overcome this issue of indefiniteness by replacing “The substituted chiral difluoropiperidinol” with “A substituted chiral difluoropiperidinol.”
Claim 6 recites the limitation “the 3,3-difluoropiperidinol derivative” and is rejected as indefinite. See line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim. In addition, parent claims 1 and 4 from which claim 6 depends therefrom also do not provide for the aforementioned limitation. Applicant may overcome this issue of indefiniteness by replacing “the 3,3-difluoropiperidinol derivative” with “a 3,3-difluoropiperidinol derivative.” Dependent claims 7-10 do not correct this issue of indefiniteness and are hence rejected.
Claim 10 recites the following limitations and is rejected as indefinite: “the said base” and “the equivalent ratio of the said 3,3-difluoropiperidinol derivative, triethylamine, formaldehyde and base.” There is insufficient antecedent basis for both of these limitations in the claim. In addition, parent claims 1, 4 and 6 from which claim 10 depends therefrom also do not provide for the aforementioned limitations.
Claim 10 recites the expression “the said organic solvent” and is rejected as indefinite. Considering that parent claims 1, 4 and 6 each recite “organic solvent,” it is unclear whether Applicant intended the expression “the said organic solvent” in claim 10 to be further limiting of the “organic solvent” as recited in a) claim 1, b) claim 4, c) claim 6, d) claims 1, 4 and 6 or other combinations of a), b) and/or c).
Claim Rejections - 35 USC § 112(d)
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.
Claim 10 is 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 10 recites two instances of the term “base.” See lines 3 and 4 of the claim. However, parent claims 1, 4 and 6 from which claim 10 depends therefrom do not recite a base. Therefore, claim 10 is broader in scope and fails to further limit the subject matter of the claims upon which it depends.
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.
Allowable Subject Matter
Claims 1-4 and 6-11 are free of the prior art. Therefore, claims 1-4 and 6-11 would otherwise be allowable if amended to overcome the issues described herein.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
