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 Claims 1. Claims 1-15 are pending. Claims 1-15 are under examination. Priority 2 . Applicant’s claim for the benefit of a provisional application under 35 U.S.C. 111(a) and 37 C.F.R 1.53(b) is acknowledged. Th is application is a continuation (CON) of U.S. Patent Application Serial Number (ASN) 16/647,413 filed 03/13//2020 which is a 371 National Stage application of PCT/US2018/051377 filed 09/17/2018 which claims the benefit of priority of Provisional Application Number 62/559,261 file 9/15/2017. Based on the filing receipt, the effective filing date of the instant application is September 15, 201 7 which is the filing date of Provisional Application 62/559,261 from which the benefit of priority is claimed. Information Disclosure Statement 3 . The information disclosure statement filed April 16, 2025 fails to comply with 37 CFR 1.98(a)(3) (i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. In this case, CN 102188704 A reference has not been provided with English translation or statement of relevancy for the cited document. It has been placed in the application file, but the information referred to therein has not been considered. 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 appl icant regards as his invention. 4 . Claims 1-1 5 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 vague and indefinite in reciting, “ combining exposed blood cells … with a panel of labeled reporters … directed against a target cell depletion surface marker, … against a target cell activation surface marker on white blood cell (WBC) populations, … against cytokine production by WBCs to thereby simultaneously produce assay signals… ” ; “measuring signals generated by each of the plurality of labeled cells ”; and “combining the measured signals into an assay output” because it is unclear how an assay output of the combined measured signals of each of the target cell depletion surface marker, target cell activation surface marker, and cytokine production by WBC can be differentially detected and measured for flow cytometric multiparameter analysis being labeled by a same fluorescent label conjugated to the panel of labeled reporters, which is encompassed in the claimed invention. It appears that each of the labeled reporters should be distinguishably detected. Claim 1 is further ambiguous in reciting, “exposing a first aliquot of whole blood sample with a first therapeutic antibody and a second aliquot of whole blood sample with a second therapeutic antibody ”, “combining exposed blood cells … with a panel of labeled reporters … directed against a target cell depletion surface marker, … target cell activation surface marker …, and … cytokine production by WBCs to thereby simultaneously produce assay signals…”; “measuring signals … ”; and “combining the measured signals into an assay output … to determine a cellular response of the first therapeutic antibody and to the second therapeutic antibody ” because it is unclear , as recited, how the combined measured signals of each of the panel of labeled reporters can be differentially detected and measured between the surface markers and in particular, between the first and the second aliquot of whole blood sample exposed with the first therapeutic antibody and the second therapeutic antibody , respectively . Claim 1 in line 15 lacks clear antecedent basis in reciting “the plurality of labeled cells.” Perhaps, Applicant intends “simultaneously produce assay signals in a plurality of labeled cells” in line 12. Claim 6 is indefinite in reciting, “wherein the white cell subpopulations include NK cells” because it is unclear what other components should be included in the white cell subpopulations other than the NK cells”. Perhaps, Applicant intends “wherein the white cell subpopulations comprise NK cells.” See also claims 9-13 with respect to the term “includes.” Claim 7 lacks clear antecedent basis in reciting “the therapeutic antibody.” Claim 9 is indefinite and confusing in reciting “the plurality of labeled reporters includes a cell surface marker and a cytokine” because it is unclear how a cell surface marker or a cytokine is a “labeled reporter” whereas claim 1 recites the “panel of labeled reporters” as those “directed against a …cell surface marker” and “directed against a cytokine” such as binding partner or antibodies. Claim 9 is further ambiguous in reciting “a cell surface marker” because it is unclear what should be encompassed in this broadly recited “a cell surface marker” relative to the “target cell depletion surface marker” and “target cell activation surface marker” in claim 1 from which it directly depends. Claim 14 lacks clear antecedent basis in reciting “the therapeutic antibody” in all occurrences of the claim. Claim Rejections - 35 USC § 102 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. 5. Claim s 1, 4 -10, 14, and 15 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Merkt et al. (Rituximab induces phenotypical and functional changes of NK cells in a non-malignant experimental setting. Arthritis Research & Therapy 18 (206): 1-11 (2016)- IDS) . Merkt et al. teach a method of analyzing target B cell response to therapeutic antibodies including Rituximab and Infliximab . Rituximab is a chimeric therapeutic antibody that targets healthy and malignant B cells and also binds to and triggers programmed cell death (PD1) and Infliximab is an antibody that targets and binds to tumor necrosis factor alpha ( TNFα) . According to Merkt et al., natural killer (NK) cells are known to lyse Rituximab-coated B cells in lymphoma studies , and are seen to mediate Rituximab-induced B cell depletion (Abstract; p. 2, left col. 1 st to 4 th full ¶ s ; p. 3, right col. 1 st & 2nd full ¶s ). Merkt et al. teach exposing peripheral blood mononuclear cells (PBMC : plurality of PBMCs ) from whole blood sample s (i.e. first aliquot and second aliquot) with Rituximab as a first therapeutic antibod y which binds to and targets B cells (target cell depletion marker) and Infliximab as second therapeutic antibody which binds to and targets TNFα ( i.e. cytokine) (Abstract; p. 2, left col. 2 nd full ¶ & right col. 3 rd full ¶; p. 3, right col. 1 st & 2nd full ¶ s ; Figure 1); and combining the exposed blood cells with a panel of labeled reporters which comprises at least two labeled reporters (antibodies) selected from a labeled reporter (antibody) directed against a target cell depletion surface marker, a labeled reporter directed against a target cell activation surface marker on white blood cell (WBC) populations, and a labeled reporter directed against cytokine production by WBCs. The labeled reporters directed against target cell depletion surface marker as taught by Merkt et al. are anti-CD16 monoclonal antibody (MAb) (Clone 3G8) and Blue Violet labeled anti-CD56 MAb (clone MY31) directed against NK cells to deplete NK cells from the PBMCs ; and FITC labeled anti-CD19 MAb directed against CD19 expressed in target B cells as a marker for depleted target B cells . The addition of rituximab to the PBMCs also resulted to target B cell depletion which is dependent on NK cells (Abstract ; p. 2, left col. 1 st to 4 th full ¶s ; p. 2, right col. 4 th full ¶: PBMC and NK cell preparation ). The labeled reporters directed against a target cell activation surface marker (co-activator) as taught by Merkt et al. are phycoerythrin (PE) -labeled anti-CD137 PE ( CD137 MAb : 4-1BB) , anti-CD69 PE ( CD69 MAb ) , and also anti- CD16 MAb and anti-CD3 PE , with CD137 , CD16 (ADCC-mediated), CD69 , and CD3 being target cell activation markers on NK WBC population ( Abstract; p. 2, left col. 1 st to 4 th full ¶s ; p. 3, left col. 1 st full ¶; Figure 1; Figure 5) . The labeled reporter directed against cytokine production in WBC s as taught by Merkt et al. is anti- TNFα antibody ( p. 3, right col. 1 st full ¶) . Merkt et al. further teach subjecting the whole blood sample mixtures to flow cytometry ; measuring signals generated by each of the plurality of labeled cells in each aliquot ; and then combining the measured signals into an assay output for analysis using multiparametric flow cytometry; the output signal providing response to each of the therapeutic antibodies (Abstract; p. 3, left and right cols.; Figure 1). The assay output comprises target B cell depletion signal by Rituximab-mediated activation signal of NK cells (WBC subpopulation) , CD137 (41BB) co-activation of NK cells , and cytokine signal by Infliximab that bound to TNFα (Abstract; p. 2, left col. 1 st full ¶). It is proper for purposes of th is anticipation rejection to interpret the " first aliquot " and “second aliquot” of the exposing step in claim 1 as the multiples of the plurality of PBMCs that are combined and stained with the cocktails of antibodies in the method taught by Merkt et al. that are subjected to flow cytometry because unpatented claims are given the broadest reasonable interpretation consistent with the specification . Accordingly, Merkt et al. appears to read on Applicant’s claimed invention. Claim Rejections - 35 USC § 103 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. 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. 6 . Claim s 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Merkt et al. (Rituximab induces phenotypical and functional changes of NK cells in a non-malignant experimental setting. Arthritis Research & Therapy 18 (206): 1-11 (2016)- IDS) in view of Dummer (US 2009/0169550) . Merkt et al. is discussed supra. Merkt et al. differ from the instant invention in failing to teach the therapeutic antibody in dry form. Dummer teaches exposing a whole blood sample to anti-CD20 therapeutic antibody that binds to and targets B cells in an assay to determine its potency in inducing human B-cell depletion in the whole blood sample [0266, 0267]. The anti-CD20 therapeutic antibody is in dried form and prepared by lyophilization for storage purposes [0269, 0272]. It would have been obvious to one or ordinary skill in the art at the time the invention was filed to substitute dried form of therapeutic antibody reagent as taught by Dummer into the method of Merkt because both Merkt and Dummer teach analogous art in assaying anti-CD20 therapeutic antibodies in their capacity for use in evaluating patient reaction to the antibody therapy. 7 . Claim 1 1 is rejected under 35 U.S.C. 103 as being unpatentable over Merkt et al. (Arthritis Research & Therapy 18 (206): 1-11 (2016)- IDS) in view of Meuer et al. (US 2015/0211064) . Merkt et al. is discussed supra. Merkt et al. differ from the instant invention in failing to teach labeled reporters comprising antibodies to interferon gamma (INFγ) and interleukin 8 (IL8). Meuer et al. teach an assay method of determining patient response to therapeutic antibody (immunoglobulin therapy) (Abstract); wherein immune response comprises modulation and activation of immune cells including T cells and B cells, and release of cytokines therefrom. In practice, Meuer et al. teach detecting cytokines such as INFγ and IL8 using fluorescent labeled reporters comprising antibodies to INFγ and IL8. It would have been obvious to one or ordinary skill in the art at the time the invention was filed to incorporate the antibodies to INFγ and IL8 as taught by Meuer into the method of Merkt because both of Merkt and Meuer teach analogous art in detecting cytokines and identifying WBC immune cell subpopulations involved in therapeutic antibody and immune cell studies. 8 . Claim 1 2 is rejected under 35 U.S.C. 103 as being unpatentable over Merkt et al. (Arthritis Research & Therapy 18 (206): 1-11 (2016)- IDS) in view of Basso-Ricci et al. (US 2020/0182870) . Merkt et al. is discussed supra. Merkt et al. differ from the instant invention in failing to teach labeled reporters comprising a ntibodies to CD66b and CD11c . Basso-Ricci et al. teach labeled reporters comprising fluorescent conjugated a ntibodies to CD66b (antiCD66 ) and CD11c ( anti-CD11c) for use in identifying WBC subpopulations including NK cells (hematopoietic cell subtypes) (Abstract; [0520]; Figure 1). It would have been obvious to one or ordinary skill in the art at the time the invention was filed to incorporate the antibodies to CD66b and CD11c as taught by Basso-Ricci into the method of Merkt because both of Merkt and Basso-Ricci teach analogous art in detecting and identifying WBC populations involved in therapeutic antibody and immune cell studies. 9 . Claim 1 3 is rejected under 35 U.S.C. 103 as being unpatentable over Merkt et al. (Arthritis Research & Therapy 18 (206): 1-11 (2016)- IDS) in view of Sainte-Laudy et al. (US 2010/0221756) . Merkt et al. is discussed supra. Merkt et al . differ from the instant invention in failing to teach labeled reporters comprising a ntibodies to CD203c, CD63, CD3, CRTH2 ( CD294 ) , and CD45. Sainte-Laudy et al. teach determining WBC subpopulation (basophil) activation using cocktails of labeled reporters comprising fluorophore labeled a ntibodies to CD203c, CD63, CD3, CRTH2 ( CD294 ) , and CD45 (Abstract; claim 3) . It would have been obvious to one or ordinary skill in the art at the time the invention was filed to incorporate the antibodies to CD203c, CD63, CD3, CRTH2 ( CD294 ) , and CD45 as taught by Sainte-Laudy into the method of Merkt because both of Merkt and Sainte-Laudy teach analogous art in detecting and identifying WBC subpopulations involved in immune cell allergy studies using multiparametric flow cytometry analysis. 10 . No claims are allowed. Remarks 11. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure: Thakar et al. (CD4 estimating reagents in dry format are compatible with conventional flow cytometer; FACSCaliber for estimation of absolute CD4 count & percentages. Indian J Med Rec 137: 346-355 (February 2013)) teach using dry reagent to obtain absolute counts and percentages of CD4, CD8, CD3+ T cells via flow cytometry (Abstract). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT GAILENE R. GABEL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0820 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Gregory S. Emch can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-8149 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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