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 .
Drawings
The drawings as submitted by Applicant on 10/27/2022 have been accepted.
Election/Restrictions
Applicant has elected claims 1-13 without traverse.
Disposition of Claims
Claims 1-38 are pending in the instant application. No claims have been added. No claims have been cancelled. No claims have been amended. Claims 1-13 are rejected herein. The rejection of the pending claims is hereby made non-final.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gustafson et al (US 2018/0340870) in view of Nitta et al (US 2017/0023579).
Regarding claim 1, the prior art discloses a method comprising: (a) contacting a tissue section with a human EGFR protein biomarker specific binding agent and detection reagents (see at least paragraph [0024] to Gustafson et al) sufficient to deposit a first chromogen in proximity to the human EGFR protein biomarker specific binding agent bound to the tissue section (see at least paragraph [0026] to Gustafson et al); (b) contacting the tissue section with an AREG protein biomarker specific binding agent (see at least Table 1, to Gustafson et al) and detection reagents sufficient to deposit a second chromogen in proximity to the AREG protein biomarker specific binding agent bound to the tissue section (see at least paragraph [0026], to Gustafson et al); and (c) contacting the tissue section with an EREG protein biomarker specific binding agent and detection reagents sufficient to deposit a third chromogen in proximity to the EREG protein biomarker specific binding agent bound to the tissue section (see at least paragraph [0026], to Gustafson et al).
Gustafson et al does not appear to explicitly disclose wherein the first chromogen is deconvolutable from the second chromogen and the third chromogen.
However, Nitta et al discloses a system and method for multiplex her2 and estrogen receptor co-staining assays for detecting tumor heterogeneity, wherein the first chromogen is deconvolutable from the second chromogen and the third chromogen (see at least paragraph [0017] to Nitta et al).
The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The examiner submits that the combination of the teaching of the system and method of predictive diagnostic workflow for tumors using automated dissection, next generation sequencing, and automated slide stainers, as disclosed by Gustafson et al and the system and method as taught by Nitta et al, in order to identify the correct treatment based on the genetic markers displayed by a cancer cell (see at least paragraph [0003] to Nitta et al), could have been readily and easily implemented, with a reasonable expectation of success. As such, the aforementioned combination is found to be obvious to try, given the state of the art at the time of filing.
Regarding claim 2, the prior art discloses the method of claim 1, wherein the biomarker specific binding agents are antibodies or antigen binding fragments thereof (see at least paragraph [0019] to Gustafson et al).
Regarding claim 3, the prior art discloses the method of claim 1, wherein the tissue section is a formalin-fixed paraffin embedded (FFPE) tissue section (see at least paragraph [0028] to Gustafson et al).
Regarding claim 4, the prior art discloses the method of claim 1, wherein the tissue section is from a colorectal tumor sample (see at least Table 1 to Gustafson et al).
Regarding claim 5, the prior art discloses the method of claim 1, wherein the tissue section is from a polyp (see at least Table 1 to Gustafson et al).
Regarding claim 6, the prior art discloses the method of claim 1, wherein the tissue section is RAS wild type (see at least Table 1 to Gustafson et al).
Regarding claim 7, the prior art discloses the method of claim 1, wherein the tissue section does not comprise a mutation that allows ligand-independent EGFR signaling (see at least paragraph [0060] to Nitta et al).
Regarding claim 8, the prior art discloses the method of claim 1, wherein the tissue section does not comprise RAS proteins with mutations that confer resistance to EGFR monoclonal antibody therapy (see at least Table 1, to Gustafson et al).
Regarding claim 9, the prior art discloses the method of claim 1, further comprising visualizing the chromogens using bright-field microscopy (see at least paragraph [0023] to Nitta et al).
Regarding claim 10, the prior art discloses the method of claim 1, wherein antigen retrieval for EGFR, EREG, and AREG are compatible (see at least paragraph [0090] to Gustafson et al).
Regarding claim 11, the prior art discloses the method of claim 1, wherein the method allows for determining spatial relationships of EGFR and EGFR ligand expression (see at least Table 1 to Gustafson et al).
Regarding claim 12, the prior art discloses the method of claim 1, wherein the second chromogen and the third chromogen are the same (see at least paragraph [0026] to Gustafson et al).
Regarding claim 13, the prior art discloses the method of claim 1, wherein the second chromogen is deconvolutable from the third chromogen (see at least paragraph [0017] to Nitta et al).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The examiner has considered all references listed on the Notice of References Cited, PTO-892.
The examiner has considered all references cited on the Information Disclosure Statement submitted by Applicant, PTO-1449.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TALIA F CRAWLEY whose telephone number is (571)270-5397. The examiner can normally be reached on Monday thru Thursday; 8:30 AM-4:30 PM EST.
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, Fahd A Obeid can be reached on 571-270-3324. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TALIA F CRAWLEY/ Primary Examiner, Art Unit 3627
