DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of group I, and ZM-306416 in the reply filed on 2/16/2026 is acknowledged.
Claims 2-3, 5, 7-10, 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/16/2026.
Priority
The instant application was filed 11/22/2023 and claims priority from provisional application 63384696 , filed 11/22/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/24/2025 are 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 for example (page 47 last line, page 48, last line 1st paragraph and 1st line 2nd paragraph) Applicant is required to review the entire specification and 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.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites, “Claim 1.” However, claim is not a proper noun or the first word of the claim and thus does not need to be capitalized.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4, 6, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antczak (Journal of Biomolecular Screening 17(7) 885 –899 © 2012)
Antczak teaches a biosensor for screening EGFR inhibitors. Antczak teaches, “Interestingly, among the confirmed inhibitors of granule formation was the VEGFR (Flt and KDR) kinase inhibitor ZM-30641621 (IC50 = 0.67 ± 0.2 µM) (Suppl. Fig. S1A), not described as potent toward EGFR kinase in the literature but sharing the 4-anilinoquinazoline scaffold common among EGFR kinase inhibitors such as erlotinib, gefitinib, and lapatinib “ (page 891, 2nd column). Antczak teaches, “Confirming the newly identified inhibitory activity of ZM-306416 toward EGFR, this compound induced selective antiproliferative effect toward the EGFR-addicted NSCLC cell lines H3255 and HCC4011 (IC50 = 0.09 ± 0.007 µM and 0.072 ± 0.001 µM, respectively), while sparing the wild-type EGFR cell lines A549 and H2030 (IC50 > 10 µM) (Fig. 4).” Antczak teaches, “our results demonstrate that this approach allows for the iden tification of known as well as novel cell-permeable and potent EGFR inhibitors such as the VEGFR kinase inhibitor ZM-306416.” (897, 1st column 1st full paragraph)
While Antczak teaches ZM-306416 is an EGFR inhibitor by analyzing NSCLC, Antczak does not specifically teach treating a subject with NSCLC with ZM-306416.
However, Antczak teaches, “The critical role of protein phosphorylation in the development and progression of many cancers has driven consider able efforts to discover therapeutic agents targeting aberrant signaling events. Receptor tyrosine kinases (RTKs) such as epidermal growth factor receptor (EGFR) play a well established role in several cancers and have become a crucial class of targets for the development of small-molecule anticancer agents.1 Besides high-profile successes such asIressa (gefitinib) and Tarceva (erlotinib), progress in identifying new drugs inhibiting RTKs has been slow in recent years. A major obstacle hampering the rapid discovery of new effective drugs inhibiting RTKs is the lack of cellular activity of potent and selective candidates originally identified in screens relying on assays using recombinant kinase domains. Such RTK inhibitors very often fail the transition from being potent toward purified recombinant protein to being active in cells, believed to be due mainly to lack of cellular permeability.”
Therefore it would have been prima facie obvious to one of skill in the art prior to the effective filing date of the claims to treat subjects with an effective amount of NSCLC with ZM-306416. The artisan would be motivated as Antczak suggests the screening method is for development of anticancer treatments. The artisan would be motivated to determine if ZM-306416 provides an effect in subjects that it did in NSCLC cells in culture. The artisan would have a reasonable expectation of success as the artisan is treating a known cancer with a known inhibitor for a target known to be present in NSCLC.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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, Anne Gussow can be reached at (571)272-6047. 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.
/Steven Pohnert/ Primary Examiner, Art Unit 1683
Prosecution Insights