CTNF 18/342,088 CTNF 88820 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-25-01 AIA Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on Feb. 24, 2026 is acknowledged. Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-14 are examined below. Priority The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Japanease Patent Application Nos. JP2022-107361 and JP2023-103678 filed on July 1, 2022 and June 23, 2023, respectively. 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Thus, the earliest possible priority for the instant application is July 1, 2022. Information Disclosure Statement The information disclosure statements filed June 28, 2023, Sept. 12, 2023 and Nov. 27, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the examiner. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Polaske et al . (WO 2016/170008 A1) in view of Koike et al . (U.S. Patent App. No. 2005/012871 A1) . The claims are directed to methods of staining a biological sample using inkjet technology using a ligan protein having specific for a target in a biological sample and a surfactant of formula 1. Polaske et al. teach inkjet printing of antibodies on histological samples (title, Ex. 2, 4 & 5). Polaske et al. does not teach inclusion of the claimed surfactants. Koike et al. teach ink for a liquid ejection head of an inkjet that including a cyclic peptide, polyoxyethylene cetyl ether and ethylene oxide adduct of acetylene glycol and acetylenol ethanol (“Formula 1 surfactant”) (Examples 1-5). The anionic cyclic peptide is considered to be a ligand protein capable of binding biological samples at least because of its anionic character. Koike et al. teach that in light of the problems that can occur with ink-jet printing of pigment inks - build-up of viscosity making start up ejection difficult (para. [0011]-[0012]); clogging of the printing nozzle (paras. [0013] –[0014]) and storage stability of the ink composition (paras. [0015] – [0016]) – these problems “can be solved with a pigment ink containing an anionic surfactant having specific properties.” (paras. [0074]-[0091]). It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Polaske et al. to incorporate the anionic surfactant (as taught by Koike et al.) because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Making this modification would have led to predictable results with a reasonable expectation of success because Koike et al. explicitly teach that the inclusion of the anionic surfactant overcomes known problems -build-up of viscosity making start up ejection difficult; clogging of the printing nozzle; and storage stability of the ink composition. Therefore, one of ordinary skill in the art would look to this solution offered by Koike et al. and reasonably expect that it would improve the process taught by Polaske et al. With respect to claim 2, Polaske et al. teach inkjet printing antibodies (Ex. 2, 4 & 5). With respect to claims 3 and 4, Polaske et al. teach the antibodies can be conjugated to enzymes, flurophores or other label, specifically enzymes and substrates, as known in the art. (paras. [0006], [0104]). With respect to claim 5, Polaske et al. teach that stabilizers, including BSA, may be included as they appear to prevent precipitation of the reagent. (para. [0110]). With respect to claims 6 and 7, Koike et al. teach the claimed mass%. (see Examples 1-5, specifically, para. [0077], also para. [0043]). With respect to claims 8 and 9, Polaske et al. teach the inclusion of a water-soluble organic solvent, specifically polyethylene glycol. (para. [0108]). With respect to claim 10, Polaske et al. teach the liquid ejection head includes a heat generating element (para. [0157]). With respect to claim 11, Koike et al. either teach a surfactant meeting the formula constraints (Acetylenol EH) or it would have been obvious to have optimized the surfactant by trying additional surfactants in the Acetylenol family, as Koike teach that using the surfactant solves the same problem applicants identified; thus, routine optimization would have led to the formula if not already taught. With respect to claims 12-14, application of secondary proteins (modified with an enzyme label) having a specificity for the ligand and having a chromogenic substrate in the sample react with the secondary protein is a routine modification, as contemplated in Polaske et al. (see e.g. para. [0006], [0097], [0104]). Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4. 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, Maria Leavitt can be reached at 571-272-1085. 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. /TERESA E KNIGHT/Primary Examiner, Art Unit 1634 Application/Control Number: 18/342,088 Page 2 Art Unit: 1634 Application/Control Number: 18/342,088 Page 3 Art Unit: 1634 Application/Control Number: 18/342,088 Page 4 Art Unit: 1634 Application/Control Number: 18/342,088 Page 5 Art Unit: 1634 Application/Control Number: 18/342,088 Page 6 Art Unit: 1634 Application/Control Number: 18/342,088 Page 7 Art Unit: 1634
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