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
Status of the Claims
Applicant’s election of Compound 001,
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as the single specific compound in the response filed on December 26th 2025 is acknowledged.
Applicant’s elected species is not found in the art. As recognized by MEPEP § 803.02(III)(C)(2):
If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The examiner need not extend the search beyond a proper Markush grouping. In other words, the examiner need not extend the search to any additional species that do not share a single structural similarity and a common use with the elected species (i.e., do not belong to the same recognized physical or chemical class or to the same art- recognized class and/or do not have a common use and/or do not share a substantial structural feature of a chemical compound and a use that flows from the substantial structural feature). The examiner should continue examination of the Markush claim to determine whether it meets all other requirements of patentability (e.g., 35 U.S.C. 101 and 112, nonstatutory double patenting, and proper Markush grouping).
Claims 1-5, 8-9, 12-16, and 19-26 are pending. Claims 19-21 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1-5, 8-9, 12-16, and 22-26 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on September 21st 2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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 (i.e., changing from AIA to pre-AIA ) 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)(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 1-2, 4-5, 8-9, 12-14, and 22-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Engelhardt (US 2022/0380382 A1 effectively filed on June 24th 2019).
The claims are directed to a compound of Formula I:
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Engelhardt teaches compound I-037:
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(Engelhardt, pg. 93, compound I-037).
Compound I-037 is equivalent to applicant’s compound wherein
X is O
A is pyridinyl
B is pyrazole
R1 is H
R2 is F
R5 is CH3
All other R groups are H
Engelhardt’s compound I-037 thereby anticipates claims 1-2, 4-5, 8-9, and 12-14.
Claim 22 is directed towards a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier. Engelhardt teaches such a composition (Engelhardt, pg. 103, claim 26), anticipating claim 22.
Claim 23 is directed towards a method of inhibiting EGFR activity in a subject via administration of a compound of claim 1. Engelhardt’s compounds are taught as EGFR inhibitors (Engelhardt, Abstract), anticipating claim 23.
Claims 24-26 are directed towards a method for treating lung cancer via administration of a compound of claim 1. Engelhardt teaches the treatment of non-small cell lung cancer (Engelhardt, pg. 12, paragraph [0150]), anticipating claims 24-26.
Allowable Subject Matter
Claims 3, 15, and 16 are free of the prior art.
Applicant has developed EGFR inhibitors of Formula I:
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Compounds of this general structure have been found in the prior art (see Engelhardt, US 2022/0380382 A1, above) and similarly have been demonstrated to inhibit the epidermal growth factor receptor (EGFR). Unique to applicant’s structure are the attachments to the A ring, as described in claims 3, 15, and 16:
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As one of ordinary skill in the art would see no reason to add this particular functional groups in the R2 location, attached to the A ring, claims 3, 15, and 16 are free of the prior art.
Claims 3, 15, and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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 supervisor, Jeffrey 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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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629