DETAILED ACTION
Claims 1-6, 8-10, 16-18, 23, 32, and 35-38 are pending.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-6, 8-10, 16-18, and 23 in the reply filed on 12/12/2025 is acknowledged.
Claims 32 and 35-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Claims 1-6, 8-10, 16-18, and 23 are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/18/2022 and 09/06/2023 have been considered by the examiner.
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.
Claims 1-6, 8-10, 16-18, and 23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Pawlak et al., (US20040166508A1) (IDS filed on 10/18/2022).
Regarding claim 1, Pawlak teaches a method of detecting a viral antibody in a biological sample of an individual (see [0140] “for the determination of pathogens, nocuous agents and germs, especially of salmonella, prions and bacteria, especially in food and environmental analytics.”, see [0077]), the method comprising:
applying an antigen-containing fluid to an assay surface (see [0159] “In each case, 30 μl of these four different antibody solutions are each applied to one of the six identical arrays of measurement areas, followed by an incubation at ambient temperature overnight (first assay step).”, see [0042] “Such compounds which are known to be involved in specific binding reactions with molecules or compounds of biological origin or with their synthetically produced analogues shall be called “biologically relevant”. Examples of “biologically relevant” compounds are thus not only naturally occurring proteins, such as antibodies or receptors, or nucleic acids, but also their binding partners, such as antigens, which may be synthetic compounds even of very low molecular weight.”, see claim 1 of ‘508 teaching samples (which can contain specific binding partners such as antigens) are applied to the assay),
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 [0107] “The samples to be analyzed, with the analytes to be determined therein, optionally after a fractionation, may be selected from the group comprising extracts of healthy or diseased cells (for example, of human, animal, bacterial or plant cell extracts), extracts of human or animal tissue, such as organ, skin, hair or bone tissue, or of plant tissue, and comprising body fluids or their constituents, such as blood, serum or plasm, synovial liquids, lacrimal fluid, urine, saliva, tissue fluid, lymph.”);
removing the antigen-containing fluid from the assay surface (see [0159] “Excess antibodies which are not specifically bound are removed by washing each array with assay buffer (5×100 μl).”, see [0042] “Such compounds which are known to be involved in specific binding reactions with molecules or compounds of biological origin or with their synthetically produced analogues shall be called “biologically relevant”. Examples of “biologically relevant” compounds are thus not only naturally occurring proteins, such as antibodies or receptors, or nucleic acids, but also their binding partners, such as antigens, which may be synthetic compounds even of very low molecular weight.”); and
determining whether the assay surface contains bound antigen (see claim 1 of ‘508 teaching the presence of the analyte to be specifically detected is determined qualitatively and/or quantitatively).
Regarding claim 2, Pawlak teaches wherein applying the antigen-containing fluid includes passing the antigen-containing fluid across the assay surface see [0159] “In each case, 30 μl of these four different antibody solutions are each applied to one of the six identical arrays of measurement areas, followed by an incubation at ambient temperature overnight (first assay step).”, see [0042] “Such compounds which are known to be involved in specific binding reactions with molecules or compounds of biological origin or with their synthetically produced analogues shall be called “biologically relevant”. Examples of “biologically relevant” compounds are thus not only naturally occurring proteins, such as antibodies or receptors, or nucleic acids, but also their binding partners, such as antigens, which may be synthetic compounds even of very low molecular weight.”, see claim 1 of ‘508 teaching samples (which can contain specific binding partners such as antigens).
Regarding claim 3, Pawlak teaches wherein applying the antigen-containing fluid includes incubating the assay surface in the antigen-containing fluid (see [0159] “In each case, 30 μl of these four different antibody solutions are each applied to one of the six identical arrays of measurement areas, followed by an incubation at ambient temperature overnight (first assay step)).
Regarding claim 4, Pawlak teaches wherein removing includes passing the antigen-containing fluid across the assay surface (see [0010] “Depending on the specific method, washing steps may be required after binding of the analytes to the recognition elements and of optional further tracer compounds and optionally between different steps of the process in order to separate the complexes formed between the recognition elements and the analytes to be determined and optional further tracer compounds from the residual part of the sample and of the additional indicator reagents that are optionally applied.”, see [0159] “Excess antibodies which are not specifically bound are removed by washing each array with assay buffer (5×100 μl).”.
Regarding claim 5, Pawlak teaches wherein removing includes flushing the antigen-containing fluid from the assay surface with an additional fluid (see [0159] “Excess antibodies which are not specifically bound are removed by washing each array with assay buffer (5×100 μl).”.
Regarding claim 6, Pawlak teaches wherein the antigen is labeled with at least one of the following: a fluorescent marker, a luminescent marker, a colormetric marker, or a radioactive marker (see [0022] “The excitation of “tracer compounds” (such as radioactive isotopes or chromophores with a characteristic absorption and/or luminescence or fluorescence) applied for analyte detection and the read-out of the signals from arrays as described is based on classical optical arrangements and detection methods.”, see [0077] “the analytes may also be biotechnologically modified polymers, e.g. biologically expressed bioloymers comprising luminescent or fluorescent groups, respectively, such as “blue fluorescent proteins” (BFP), “green fluorescent proteins” (GFP), or “red fluorescent proteins” (RFP).”, see [0154] “In addition to the measurement areas comprising deposited samples, each microarray comprises additional measurement containing immobilized bovine serum albumin fluorescently labeled with Cy5 (Cy5-BSA)”).
Regarding claim 8, Pawlak teaches wherein detecting includes label-free detecting (see claim 36 of ‘508 teaching determining the refractive index, see [0029] “In the case of refractive measurement methods, the change in the so-called effective refractive index resulting from molecular adsorption to or desorption from the waveguide is used for analyte detection. This change in the effective refractive index is determined, in the case of grating coupler sensors, from changes in the coupling angle for the in- or out-coupling of light into or out of the grating coupler sensor and, in the case of interferometric sensors, from changes in the phase difference between measurement light guided in a sensing arm and a reference arm of the interferometer.”, it is widely known in the art that refractive measurement methods are label-free).
Regarding claim 9, Pawlak teaches wherein the biological sample is blood, blood serum, or blood plasma (see [0107] “The samples to be analyzed, with the analytes to be determined therein, optionally after a fractionation, may be selected from the group comprising extracts of healthy or diseased cells (for example, of human, animal, bacterial or plant cell extracts), extracts of human or animal tissue, such as organ, skin, hair or bone tissue, or of plant tissue, and comprising body fluids or their constituents, such as blood, serum or plasm, synovial liquids, lacrimal fluid, urine, saliva, tissue fluid, lymph.”).
Regarding claim 10, Pawlak teaches further comprising, 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 (see [0161] teaching a second assay being performed for detection of bound analyte specific antibodies using Cy5-labeled (fluorescent) anti-rabbit antibody); and
removing the labeling fluid from the assay surface (see [0161] teaching the arrays being washed with assay buffer).
Regarding claim 16, Pawlak teaches wherein the assay surface includes a plurality of biological samples from a plurality of individuals (see [0115] teaching different deposited samples may also have been taken from different organisms or different cell cultures).
Regarding claim 17, Pawlak teaches wherein determining includes simultaneously determining whether the antigen is bound to each of the plurality of biological samples (see [0006] “Thereby, the changes in opto-electronic signals, resulting from the binding of tracer compounds to analytes contained in the samples in discrete measurement areas in the evanescent field of the sensor platform, may be determined, for example, from a comparison of the simultaneously measured signals from different measurement areas containing analytes to be determined (at a known or unknown concentration and/or amount) with the signals from measurement areas which do not contain the corresponding analytes to be determine”, see [0083] “different analytes can be determined in a single detection step, i.e. when the measurement areas are brought into contact with said detection reagents and the generated luminescences are detected simultaneously or consecutively.”).
Regarding claim 18, Pawlak teaches wherein determining includes sequentially determining whether the antigen is bound to each of the plurality of biological samples (see [0006], see [0083]).
Regarding claim 23, Pawlak 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 (see [0140] “for the determination of pathogens, nocuous agents and germs, especially of salmonella, prions and bacteria, especially in food and environmental analytics.”, see [0077], see [0107] teaching the biological sample being human blood, see [0115] teaching different deposited samples may also have been taken from different organisms or different cell cultures), the method comprising:
affixing a first biological sample of a first individual to an assay surface (see [0115] teaching different deposited samples may also have been taken from different organisms or different cell cultures, see [0147] “Six identical microarrays, each with 90 measurement areas (spots) arranged in 10 rows and 9 columns, are deposited on the evanescent field sensor platform provided with a hydrophobic adhesion-promoting layer, using an inkjet spotter (model BCA1, Perkin Elmer, Boston, Mass., USA). Each spot is generated by deposition of a single droplet of 280 pl volume on the chip surface.”);
affixing a second biological sample of a second individual to the assay surface (see [0115] teaching different deposited samples may also have been taken from different organisms or different cell cultures, see [0147] “Six identical microarrays, each with 90 measurement areas (spots) arranged in 10 rows and 9 columns, are deposited on the evanescent field sensor platform provided with a hydrophobic adhesion-promoting layer, using an inkjet spotter (model BCA1, Perkin Elmer, Boston, Mass., USA). Each spot is generated by deposition of a single droplet of 280 pl volume on the chip surface.”);
applying an antigen-containing fluid to the assay surface, the antigen-containing fluid containing an antigen for a virus are applied to the assay surface (see [0159] “In each case, 30 μl of these four different antibody solutions are each applied to one of the six identical arrays of measurement areas, followed by an incubation at ambient temperature overnight (first assay step).”, see [0042] “Such compounds which are known to be involved in specific binding reactions with molecules or compounds of biological origin or with their synthetically produced analogues shall be called “biologically relevant”. Examples of “biologically relevant” compounds are thus not only naturally occurring proteins, such as antibodies or receptors, or nucleic acids, but also their binding partners, such as antigens, which may be synthetic compounds even of very low molecular weight.”, see claim 1 of ‘508 teaching samples (which can contain specific binding partners such as antigens), see [0140] “for the determination of pathogens, nocuous agents and germs, especially of salmonella, prions and bacteria, especially in food and environmental analytics.”);
removing the antigen-containing fluid from the assay surface (see [0159] “Excess antibodies which are not specifically bound are removed by washing each array with assay buffer (5×100 μl).”, see [0042] “Such compounds which are known to be involved in specific binding reactions with molecules or compounds of biological origin or with their synthetically produced analogues shall be called “biologically relevant”. Examples of “biologically relevant” compounds are thus not only naturally occurring proteins, such as antibodies or receptors, or nucleic acids, but also their binding partners, such as antigens, which may be synthetic compounds even of very low molecular weight.”); and
determining whether the assay surface contains bound antigen (see claim 1 of ‘508 teaching the presence of the analyte to be specifically detected is determined qualitatively and/or quantitatively).
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