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
Applicant’s preliminary amendment dated 24 June 2024, in which claims 1, 5, 8, 9, 11, 14, 18, 20, 24, 25, 30, 31, 34, 39, and 42 have been amended, and claims 3, 4, 7, 12, 13, 16, 17, 19, 21, 23, 26-29, 32, 33, 35-38, 40, 41, and 43 have been cancelled, is acknowledged.
Claims 1-2, 5-6, 8-11, 14-15, 18, 20, 22, 24-25, 30-31, 34, 39, 42 are pending in the instant application.
Claims 18, 22, 24-25, 30-31, 34, 39, 42 are withdrawn, as being drawn to a non-elected invention.
Claims 1-2, 5-6, 8-11, 14-15, 20 are being examined herein.
Priority
The instant application is a National Stage entry of International Application No. PCT/US2022/073706, filed on 13 July 2022, which claims priority from U.S. Provisional Patent Application 63/188,884, filed on 14 May 2021.
Applicant’s amendment to the Specification, submitted on 13 November 2023, stating the correct priority, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12 February 2024, 24 June 2024, and 27 March 2026 (total 4 documents), are acknowledged and considered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, 5-6, 8-11, 14-15, 20, drawn to a composition comprising a quinazoline compound of formula I, and a pharmaceutical composition thereof, in the Response of 27 March 2026, is acknowledged. Claims 18, 22, 24-25, 30-31, 34, 39, 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Because Applicant has set forth no arguments against the requirement for restriction, the requirement for restriction between Groups I to X is maintained and is herein made FINAL.
Applicants’ election without traverse of compound 63 below
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as the species of a compound of formula (I), for initial examination, in the Reply of 27 March 2026, is acknowledged. Claims 1-2, 5-6, 8-10, 15, 20 encompass the elected species.
In the interest of compact prosecution, the requirement for election of species is herein withdrawn.
Claims 1-2, 5-6, 8-11, 14-15, 20 have been examined and the following objections are rejections are made below.
Claims Objections
Claims 18, 22, 24-25, 30-31, 34, 39, 42, while currently withdrawn, are objected to because of the following informality: The withdrawn claims are objected to for being presented in a non-compliant form. Specifically, the status identifier states the claims is “(Original)”, or “(Currently amended)”, but the claims are withdrawn because of the election made by the Applicant on 27 March 2026. As such, claims 18, 22, 24-25, 30-31, 34, 39, 42 should be identified as "(Withdrawn)" until such time as examiner rejoins the claims for examination. Appropriate correction is required. See MPEP 714(C).
Claims 2, 5-6, 8-11, 14-15, 20 are objected to because they depend on claim 1, and, as such, they should recite “The composition of claim 1” instead of “A composition of claim 1”.
Objection to the Specification
The Specification is objected to because it contains reference to Figures with incorrect numbers (numbers that do not correspond to the numbering of Figures in this application) and reference to Synthetic Schemes not included in the original disclosure.
It is noted that the text in the Specification [00108]-[00117] follows the text in an article by Wagner-Griffin et al. (J. Med. Chem. 2021, 64, 8474-8485, cited in IDS), which references Figures and Schemes in the Supporting Information section, Supplementary Tables and Figures, and Synthetic Schemes. Some of the Tables and Figures are included in the instant disclosure, but with different numbers, while the Synthetic Schemes referenced are not included.
For example, [00108] recites (Figure S1), which corresponds to Figure 6 in Applicant’s disclosure.
Further, [00108] recites (Figure S2), which corresponds to Figure 7 in Applicant’s disclosure.
Paragraph [00109] recites (Figures S3-S6), which corresponds to Figures 8-11 in Applicant’s disclosure.
Paragraph [00109] also recites on page 17 (Figure S7), which corresponds to Figure 12 in Applicant’s disclosure; and (Figure S8), which corresponds to Figure 13 in Applicant’s disclosure.
Paragraph [00111] recites (Figure S10), which corresponds to Figure 15 in Applicant’s disclosure.
Paragraph [00111] recites (Scheme 1 in Supporting Information); yet no Synthetic Scheme is included in Applicant’s disclosure.
Paragraph [00113] recites (Schemes 2 and 3), (Intermediate D, Scheme 2), (Intermediate D, Scheme 3); yet no Synthetic Scheme is included in Applicant’s disclosure.
Paragraph [00113] recites (Figure S10) which corresponds to Figure 15 in Applicant’s disclosure.
Paragraph [00114] recites (Figure S11), which corresponds to Figure 16 in Applicant’s disclosure.
Paragraph [00114] recites (Figure S12) (two instances), which corresponds to Figure 17 in Applicant’s disclosure.
Paragraph [00116] recites (Figure S13), which corresponds to Figure 18 in Applicant’s disclosure.
Paragraph [00117] recites (Figure S14) (two instances), which corresponds to Figure 19 in Applicant’s disclosure.
Applicant is required to identify all instances and amend the Specification referencing the correct numbers for the Figures.
Applicant is required to identify all instances and remove from the Specification references to Synthetic Schemes not included in the disclosure.
Further, the Specification is objected to because of the lack of clarity in the definition of R3 and R4 in [0009] (see also claim rejection below under 35 U.S.C. 112(b), as being indefinite).
Paragraph [0009] in the Specification recites compounds of formula I wherein
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It is unclear whether the last substituent listed
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is part of the definition of R4, or rather is part of the definition of R3. [0009], as written, seems to indicate that each instance of R4 is independently one of 3 possibilities: H, methyl or -NH(CH2)2NMe2.
Yet, it is noted that example compound 79
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in Applicant’s Specification (Figure 15) corresponds to a compound of formula I where R3 is -NH(CH2)2NMe2 (not R4). Note also that claim 14 recites that R3 is -NH(CH2)2NMe2 . Further, the Specification does not exemplify any compound of formula I where R4 is -NH(CH2)2NMe2.
As such, there is confusion related to the definitions for R3 and R4.
Appropriate clarification 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 1-2, 5-6, 8-11, 14-15, 20 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 rejected because of the lack of clarity in the definition of R3 and R4.
Claim 1 is drawn to a composition comprising a compound of formula I wherein
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It is unclear whether the last substituent listed
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is part of the definition of R4, or rather is part of the definition of R3. Claim 1, as written, seems to indicate that each instance of R4 is independently one of 3 possibilities: H, methyl or -NH(CH2)2NMe2.
Yet, it is noted that example compound 79
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in Applicant’s Specification (Figure 15) corresponds to a compound of formula I where R3 is -NH(CH2)2NMe2 (not R4). Note also that claim 14 recites that R3 is -NH(CH2)2NMe2 . Further, the Specification does not exemplify any compound of formula I where R4 is -NH(CH2)2NMe2.
As such, there is confusion related to the definitions for R3 and R4.
Appropriate clarification is required.
If claim 1 is interpreted to mean that each instance of R4 is independently one of 3 possibilities: H, methyl or -NH(CH2)2NMe2, claim 14 is rejected (see below) on the grounds of lack of antecedent basis.
Claim 14 is drawn to the composition of claim 1, wherein R3 is -NH(CH2)2NMe2; yet claim 1 recites that
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, which is interpreted to mean that each instance of R4 is independently one of 3 possibilities: H, methyl or -NH(CH2)2NMe2. As such,
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is part of the definition of R4, not part of the definition of R3 in claim 1, and therefore there is insufficient antecedent basis for the limitation R3 is -NH(CH2)2NMe2 of claim 14, in claim 1.
Appropriate correction is required.
Conclusion
Claims 1-2, 5-6, 8-11, 14-15, 20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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