DETAILED ACTION
Claims 1-6, 8-10, 16-18, 23, 32, and 35-38 are pending.
Status of Claims
Claims 1-6, 8-10, 16-18, 23, 32, and 35-38 are pending. Claims 32 and 35-38 have been withdrawn.
Claims 1-6, 8-10, 16-18, and 23 are under examination.
Withdrawn Claim Objections and/or Rejections
The rejection of claims 1-6, 8-10, 16-18, and 23 under 35 USC 103 as being unpatentable over Pawlak et al., as set forth on pp. 3-9 of the previous office action (mailed on 02/19/2026) has been withdrawn in view of the arguments (filed on 04/09/2026) on page 5, where applicant argues that Pawlak does not teach removing the antigen-containing fluid from the assay surface.
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)(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.
(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.
Claim(s) 1-6, 9-10, 16-18, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mezzasoma et al., Antigen Microarrays for Serodiagnosis of Infectious Diseases, Clinical Chemistry, Volume 48, Issue 1, 1 January 2002, Pages 121–130, https://doi.org/10.1093/clinchem/48.1.121.
Mezzasoma teaches a method of detecting a viral antibody in a biological sample of an individual (see page 121 under background “We generated protein microarrays by printing microbial antigens to simultaneously determine in human sera antibodies directed against Toxoplasma gondii, rubella virus, cytomegalovirus (CMV), and herpes simplex virus (HSV) types 1 and 2 (ToRCH antigens)”), the method comprising:
applying an antigen-containing fluid to an assay surface, the antigen-containing fluid containing an antigen for the virus to be detected and the assay surface containing a biological sample from the individual (see page 122 under Preparation of Microarrays “Microbial antigens as well as human IgG and IgM at different concentrations were printed on silanized glass microscope slides (CEL Associates), using computer-controlled high-speed robotics (Total Array System; Biorobotics). Samples were transferred from 384 microtiter plates to glass slides by use of stainless steel solid pins (200-m diameter).”, see page 121 “The slides were incubated first with serum samples and subsequently with fluorescently labeled secondary antibodies.”);
removing the antigen-containing fluid from the assay surface (see page 123 “To reveal IgG bound to the printed antigens, the slides were washed five times (1 mL each time) with PBS containing 0.1 mL/L Tween 20 and subsequently incubated for 5 min with Alexa 546-labeled anti-human IgG monoclonal antibody 2F6 (Radim) suspended in a solution containing 2 PBS, 10 g/L bovine serum albumin, and 0.1 mL/L Tween 20. To reveal IgM, the slides were incubated for 5 min with Alexa 594-labeled goat immunoglobulins directed against the anti-human IgM chain (OEM Concepts Inc.). Before the fluorescence was read in the scanner, the slides were washed and dried at 37 °C. The secondary antibodies, monoclonal antibody 2F6 and the goat immunoglobulins, were labeled with succinimidyl Alexa 546 and 594, respectively, and purified according to the instructions provided by the manufacturer (Molecular Probes Inc.)”); and
determining whether the assay surface contains bound antigen (see page 122 “We used a protein microarray to determine in human sera the presence of specific antibodies directed against parasite and viral antigens, including Toxoplasma gondii, cytomegalovirus (CMV),3 rubella virus, and herpes sim plex virus (HSV) types 1 and 2.”) (instant claim 1).
Mezzasoma teaches the antigen-containing fluid is passed across the assay surface (see page 122 “Microbial antigens as well as human IgG and IgM at different concentrations were printed on silanized glass microscope slides (CEL Associates), using computer-controlled high-speed robotics (Total Array System; Biorobotics) (22). Samples were transferred from 384 microtiter plates to glass slides by use of stainless-steel solid pins (200-m diameter)”, see figure 1) (instant claims 2 and 4) and incubating the assay surface with the antigen-containing fluid (see page 122 under “Preparation of Microarrays”) (instant claim 3). Mezzasoma teaches flushing the antigen-containing fluid from the assay surface with an additional fluid (see page 123 under “Processing of Microarray Slides” teaching the assay is washed with PBS) (instant claim 5). Mezzasoma teaches the antigen is labeled with a fluorescent marker and the biological sample is serum (see page 121 “The antigens were printed on activated glass slides with high-speed robotics. The slides were incubated first with serum samples and subsequently with fluorescently labeled secondary antibodies.”) (instant claims 6 and 9). Mezzasoma teaches after the removing step and before the determining step: applying a labeling fluid to the assay surface, the labeling fluid containing a labeled secondary antibody capable of binding to the antigen; and removing the labeling fluid from the assay surface (see page 121 “The slides were incubated first with serum samples and subsequently with fluorescently labeled secondary antibodies”, see page 123 “To reveal IgG bound to the printed antigens, the slides were washed five times (1 mL each time) with PBS containing 0.1 mL/L Tween 20 and subsequently incubated for 5 min with Alexa 546-labeled anti-human IgG monoclonal antibody 2F6 (Radim) suspended in a solution containing 2x PBS, 10 g/L bovine serum albumin, and 0.1 mL/L Tween 20... Before the fluorescence was read in the scanner, the slides were washed and dried at 37 °C. The secondary antibodies, monoclonal antibody 2F6 and the goat immunoglobulins, were labeled with succinimidyl Alexa 546 and 594, respectively, and purified according to the instructions provided by the manufacturer (Molecular Probes Inc.).”) (instant claim 10). Mezzasoma teaches wherein the assay surface includes a plurality of biological samples from a plurality of individuals (see page 122 “Human sera (n =60) were supplied by BioMedical Resources Inc.”) (instant claim 16).
Mezzasoma teaches wherein determining includes simultaneously determining whether the antigen is bound to each of the plurality of biological samples (see figure 3 and figure 3 legend “Fig. 3. Fluorescent scans of antigen arrays incubated with samples from VP6678/1 (A), VP6678/15 (B), VP6628/2 (C), and VP6627/8 (D) serum panels, which differ according to their reactivities in ELISA in the presence of IgG directed against the ToRCH antigens. Serum antibodies were detected by incubating the slides with Alexa 546-labeled secondary antibody directed against human IgG. The intensity of fluorescence emitted by the fluorophore was visualized in a pseudo-color scale (dark blue to white)”) (instant claim 17). Mezzasoma teaches wherein determining includes sequentially determining whether the antigen is bound to each of the plurality of biological samples (see figure 3 and figure 3 legend, see figure 4, see pages 16-127 under “Analysis of Serum Reactivity Against Arrayed Antigens”) (instant claim 18).
Mezzasoma teaches a method of detecting the presence or absence of a viral antibody in any of a plurality of biological samples of a plurality of individuals, the method comprising: affixing a first biological sample of a first individual to an assay surface; affixing a second biological sample of a second individual to the assay surface; applying an antigen-containing fluid to the assay surface, the antigen-containing fluid containing an antigen for a virus; removing the antigen-containing fluid from the assay surface; and determining whether the assay surface contains bound antigen (see page 123 “Printed slides were incubated for 1 h at room temperature with a solution containing 10 g/L bovine albumin in PBS to block nonspecific antibody binding. An adhesive tape (Gene-Frame; Abgene Limited) was used to contain samples/ reagents within the array area. Serum samples were diluted 1:200 in 2_ PBS containing 10 g/L bovine serum albumin and 0.1 mL/L Tween 20 and allowed to react with the array for 15 min at room temperature in a humid chamber. To reveal IgG bound to the printed antigens, the slides were washed five times (1 mL each time) with PBS containing 0.1 mL/L Tween 20 and subsequently incubated for 5 min with Alexa 546-labeled anti-human IgG monoclonal antibody 2F6 (Radim) suspended in a solution containing 2_ PBS, 10 g/L bovine serum albumin, and 0.1 mL/L Tween 20. To reveal IgM, the slides were incubated for 5 min with Alexa 594-labeled goat immunoglobulins directed against the anti-human IgM µ chain (OEM Concepts Inc.).”, see page 121 under “Methods” teaching the use of human IgG and IgM, see page 122 “Microbial antigens as well as human IgG and IgM at different concentrations were printed on silanized glass microscope slides”, see page 122 under “Preparation of Microarrays” and under “Serum Samples and Elisa Methods”, see page 122 “We used a protein microarray to determine in human sera the presence of specific antibodies directed against parasite and viral antigens, including Toxoplasma gondii, cytomegalovirus (CMV),3 rubella virus, and herpes sim plex virus (HSV) types 1 and 2.”) (instant claim 23).
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.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mezzasoma et al., as applied to 1-6, 9-10, 16-18, and 23 above, in view of Mace et al., Label-free, arrayed sensing of immune response to influenza antigens. Talanta. 2011 Jan 15;83(3):1000-5. doi: 10.1016/j.talanta.2010.11.002. Epub 2010 Nov 10. PMID: 21147350; PMCID: PMC3026320.
The teachings of Mezzasoma as it pertains to claims 1-6, 9-10, 16-18, and 23 are discussed in the 35 USC 102 rejection above.
Mezzasoma does not teach label free detection.
Mace teaches the use of label-free microarray detection (see page 4 “We demonstrated this concept using a microarray AIR format to examine a second set of serum samples from a subsequent avian influenza vaccination trial [xxvi].”, see page 4 under “Microarrays”. AIR is arrayed imaging reflectometry, which is a label-free optical sensor (see abstract)) (instant claim 8).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant application to combine the methods detecting a virus in an individual taught by Mezzasoma with the methods of label free microarray detection taught by Mace. Mace provides motivation by teaching that AIR label free detection in combination with microarrays provides sensitivity and multiplexing capabilities (see page 5). Mace provides motivation by teaching that the use of secondary antibodies (such as the ones in the label free detection methods) provides significant cost advantages relative to ELISA or traditional microarrays (see page 5). Mace provides further motivation by teaching that the simplicity of the microarray AIR assay makes it suitable for implementation in a field-deployable instrument (see page 5). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
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