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 .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). Claims cannot have duplicate numbers.
Second duplicate claim 9 renumbered to claim 10. All subsequent claims after claim 10 are renumbered by an increase in one (e.g., original claim 10 is now claim 11, original claim 14 is now claim 15).
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 applicant regards as his invention.
Claims 12-13 and 19-20 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.
In claims 12-13 and 18-19, they recite “[…] 1% Ten-20 and 2% Bovine Serum Albumin.”. It is unclear what the percentage is referencing, as it may either be a weight percent, or volume/total percent. The examiner is interpreting the percentage as volume percent/vol%.
Claims 4 and 18 recites the limitation "[…] the […]" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claims 15 recites the limitation "[…] the […]" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US PG-Pub 20160080548 A1, as cited in the IDS), in view of Mccord et al. (US PG-Pub 20210299651 A1, as cited in the IDS).
Regarding claim 1, Erickson et al. teaches a method for obtaining a point-of-collection, selected quantitative indicia of an analyte on a test strip using a smartphone involves imaging a test strip on which a colorimetric reaction of a target sample has occurred due to test strip illumination by the smartphone. This includes a quantitative analyses of bodily fluids like saliva, where it may contain indicators of pH and calcium concentrations for determining dental hygiene and health, as well as determining if periodontitis is present (see Erickson et al., Abstract, [0016], [0138]). The use of smartphone solutions are contemplated as portable diagnostic devices, with a mReader software installed onto the system to allow for reading lateral flow tests by analyzing test strip images taken from the smartphone cameras (see Erickson et al., [0004]-[0005]). The smartphone when capturing an image can store the time and/or location data in at least one of a readable file in the smartphone, an external readable file, and in a Cloud file (i.e., a file relating to the patient), which can be read by the application later (see Erickson et al., [0042], [0136]) The disposable test strip can collect the sample through swiping the disposable strip through it, and receive pH, sodium concentration measurement and/or lateral flow results in a few seconds. The smartphone reading the lateral flow test strips can accurately determine the number of colorimetric lines that develop, distinguishing between a positive and negative result. The smartphone can then obtain the image of the test strip, and displaying results on the smartphone screen for immediate user feedback, as well as being stored for later access (see Erickson et al., [0137], [0176]).
Erickson et al. fails to teach a test card, the card further including apertures for placement saliva, test strip visualization, and color visualization.
However, in the analogous art of multi-factor urine test system that adjusts for lighting and timing, McCord et al. teaches a card containing multiple tests that can have a bodily fluid sample applied, such as saliva, where the card can have its image captured by a phone for analysis performed by it to determine test results. The test card includes test regions, which further may include colorimetric tests and lateral flow assays. The test card may also contain color fiducials for color correction, and one or more-time indicators for timing correction (see McCord et al., Abstract, [0001], [0033]). Test regions may be exposed directly to a urine (or saliva) sample, or may receive the sample for example from another pad or which the chamber to which the body fluid is added. The lateral flow assay regions 202b through 202e receive the sample from corresponding pads 201b, 201c, 201d, and 201e. Each test region may also contain reagents or combinations of reagents that react with specific elements that may be present in a urine (or saliva) sample to generate a visible change in the appearance of the test region. Test card 100 also contains two rows of color fiducial markers such as 221a and 221b at the top of the image in FIG. 2, and 221c and 221d at the bottom of the image in FIG. 2 (see McCord et al., Fig. 2, [0040]-[0041], [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis of bodily fluids of Erickson et al. to incorporate a card comprising a lateral flow assay and colorimetric assay, which has additional apertures for obtaining the sample, visualization of changes in test strip, and color markings on the test card (as taught by McCord et al.), for the benefit of providing multiple analyte detection on the test card, where this enables adjusting for variable lighting conditions and timing (see McCord et al., [0001]).
Regarding claim 5, the combination of Erickson et al. and McCord et al. teaches the exact limitations of claim 5. Specifically, Erickson et al. teaches the method of Claim 1, wherein the lateral flow assay and colorimetric assay comprise a plurality of immunoassay test strips (see Erickson et al., [0050], disclosing that the assay test platform is a disposable lateral flow immunochromatographic test strip).
Regarding claim 6, the examiner is using broadest reasonable interpretation of the "top" of the test card to be the side facing up.
Erickson et al. fails to teach wherein the test card includes a top side wherein the plurality of apertures for placement saliva, test strip visualization, and color visualization are formed.
However, McCord et al. teaches a test card containing multiple tests that can have a bodily fluid sample applied. The test card 100 includes test regions, which further may include colorimetric tests and lateral flow assays. The test card may also contain color fiducials for color correction, and one or more-time indicators for timing correction. These test regions, including the lateral flow assay regions 202b through 202e, the colorimetric test regions 203a through 205f are arranged on the top of the test card as seen in Fig. 2. The lateral flow assay regions additionally receive sample corresponding pads 201b, 201c, 201d, and 201e. (see McCord et al., Abstract, Fig. 2, [0001], [0033], [0040]-[0041]). Each test region may contain reagents or combinations of reagents that react with specific elements that may be present in a urine sample to generate a visible change in the appearance of the test region. The test card 100 also contains two rows of color fiducial markers such as 221a and 221b at the top of the image in FIG. 2, and 221c and 221d at the bottom of the image in FIG. 2 (see McCord et al., Fig. 2, [0040], [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis of bodily fluids of Erickson et al. to incorporate a card comprising on the top side of it having a lateral flow assay and colorimetric assay, which has additional apertures for obtaining the sample, visualization of changes in test strip, and color markings on the test card (as taught by McCord et al.), for the benefit of providing multiple analyte detection on the test card by having all the assays and apertures arranged on the top side, where this enables adjusting for variable lighting conditions and timing when capturing an image with a smartphone (see McCord et al., [0001], [0003]).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al. and McCord et al. as applied to claim 1 above, and further in view of Chou et al. (US PG-Pub 20210072122 A1, as cited in the IDS).
Regarding claim 2, the combination of Erickson et al. and McCord et al. fails to teach wherein the biomarkers are selected from the group consisting of Glucosyltransferase, a dipeptidyl peptidase. Atopobium parvulum, Eubacterium sulci, Fusobacterium periodonticum and Solobacterium moorei.
However, in the analogous art compressed open flow assay and use, Chou et al. teaches using a compressed regulated open flow device that includes a plurality of capture agents that each bind to a plurality of analytes in a sample, of which includes dipeptidyl-peptidase 4 (CD26, adenosine deaminase complexing protein 2) (see Chou et al., Table 2B, [0967]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biomarker of the combination of Erickson et al and McCord et al. to incorporate the binding agent dipeptidyl-peptidase 4 as a biomarker (as taught by Chou et al.), for the benefit being able to use a bio/chemical sensor in detecting biomarkers associated with dental or oral diseases and conditions.
Regarding claim 3, the combination of Erickson et al. and McCord et al. fails to teach wherein the dipeptidyl peptidase is dipeptidyl peptidase-4/CD26.
However, Chou et al. teaches using a compressed regulated open flow device that includes a plurality of capture agents that each bind to a plurality of analytes in a sample, of which includes dipeptidyl-peptidase 4 (CD26, adenosine deaminase complexing protein 2) (see Chou et al., Table 2B, [0967]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biomarker of the combination of Erickson et al and McCord et al. to incorporate the binding agent dipeptidyl-peptidase 4/CD26 as a biomarker (as taught by Chou et al.), for the benefit being able to use a bio/chemical sensor in detecting biomarkers associated with dental or oral diseases and conditions.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al. and McCord et al. as applied to claim 1 above, and further in view of Garreto et al. ("Mapping Salivary Proteases in Sjögren’s Syndrome Patients Reveals Overexpression of Dipeptidyl Peptidase-4/CD26", as cited in the IDS).
Regarding claim 4, the combination of Erickson et al., McCord et al., and Chou et al. fails to teach wherein the dipeptidyl peptidase is the serine protease overexpressed in Sjogren's Syndrome.
However, in the analogous art of "Mapping Salivary Proteases in Sjögren’s Syndrome Patients Reveals Overexpression of Dipeptidyl Peptidase-4/CD26", Garreto et al. teaches an evaluation of differentially expressed proteases in Sjögren’s Syndrome Patients, where an increased activity of serine protease dipeptidyl peptidase-4/CD26 in primary Sjögren’s Syndrome saliva, the expression level of which was corroborated by ELISA assay (see Garreto et al., Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dipeptidyl peptidase of the combination of Erickson et al., McCord et al., and Chou et al. to incorporate the increased expression of serine protease dipeptidyl peptidase-4/CD26 in primary Sjögren’s Syndrome saliva (as taught by Garreto et al.), for the benefit of non-invasive means of obtaining Sjögren’s Syndrome biomarkers in patients for diagnosis (see Garreto et al., Abstract).
Claims 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al. and McCord et al. as applied to claim 7 above, and further in view of Brancozio (US PG-Pub 20120123297 A1, as cited in the IDS).
Regarding claim 7, the combination of Erickson et al. and McCord et al. fails to teach wherein the top side of the test card further includes a color wheel against which the color of the color indicator may be compared.
However, in the analogous art of system and interfaces for blood sampling, Brancozio teaches quantitative and/or qualitative analysis of analytes from a blood sample (or other bodily fluids like saliva) through a device. A "color wheel" may be provided onto the device where an of a particular analyte present can control which colors of the wheel are visible. Or, different analytes can cause different colors of a wheel or different bars of a graph to become visible or invisible in a multiple analyte analysis. Multiple-analyte quantitative analyses can be reflected in multiple color wheels, a single-color wheel with different colors per analyte where the intensity of each color reflects the amount of the analyte (see Brancozio, [0042], [0229]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis of bodily fluids and test card with top arranged apertures and assays of the combination of Erickson et al. and McCord et al. to incorporate further adding a color wheel (as taught by Brancozio) similarly arranged on top of the test card, for the benefit of having a comparable signal to a reference color for determination of results.
Regarding claim 8, the combination of Erickson et al. and McCord et al. fails to teach the method including a color key for identifying a possible disease state.
However, Brancozio teaches quantitative and/or qualitative analysis of analytes from a blood sample (or other bodily fluids like saliva) through a device. A "color wheel" may be provided onto the device where an of a particular analyte present can control which colors of the wheel are visible. Or, different analytes can cause different colors of a wheel or different bars of a graph to become visible or invisible in a multiple analyte analysis. Additionally, the analytes from the bodily fluids of a subject often contain analytes that are important for diagnostic purposes, for example, markers for various disease states (see Brancozio, [0042], [0172], [0229]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis of bodily fluids and test card with top arranged apertures and assays of the combination of Erickson et al. and McCord et al. to incorporate further adding a color wheel for analytes indicative of disease states (as taught by Brancozio), for the benefit of having a comparable signal to a reference color for determination of results and further patient diagnostics.
Regarding claim 10, the combination of Erickson et al. and McCord et al. fails to teach the method including the step of comparing the color of the color indicator against the color wheel to identify a color change and identifying the disease state by reviewing the color key.
However, Brancozio teaches quantitative and/or qualitative analysis of analytes from a blood sample (or other bodily fluids like saliva) through a device. A "color wheel" may be provided onto the device where an of a particular analyte present can control which colors of the wheel are visible. Or, different analytes can cause different colors of a wheel or different bars of a graph to become visible or invisible in a multiple analyte analysis. Additionally, the analytes from the bodily fluids of a subject often contain analytes that are important for diagnostic purposes, for example, markers for various disease states (see Brancozio, [0042], [0172], [0229]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis of bodily fluids and test card with top arranged apertures and assays of the combination of Erickson et al. and McCord et al. to incorporate further adding a color wheel for analytes indicative of disease states based on the color change (as taught by Brancozio), for the benefit of having a comparable signal to a reference color for determination of results and further patient diagnostics.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al. and McCord et al. as applied to claim 1 above, and further in view of Rudman et al. (US PG-Pub 20140322661 A1, as cited in the IDS).
Regarding claim 9, while the combination of Erickson et al. and McCord et al. teaches using a plurality of lateral flow assays on a test card (see claim 1 rejection), the combination of Erickson et al. and McCord et al. fails to teach wherein the assays are two sandwich immunoassays.
However, in the analogous art of diagnostic mouthpieces, Rudman et al. teaches a diagnostic mouthpiece capable of reacting with salivary biomarkers for detecting dental/oral conditions. The lateral flow test strips used on the diagnostic pads have reagents sequentially placed so that capillary flow of the saliva allows a reaction. Such examples of a lateral flow test strip include the use of sandwich immunoassays (see Rudman et al., Abstract, [0003], [0013], [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lateral flow assays of the combination of Erickson et al. and McCord et al. by incorporating sandwich immunoassays into the plurality of lateral flow assays, or limited to two (as taught by Rudman et al.), for the benefit of using a mouthpiece style of diagnostic platform for direct collection of sample and acquiring marker indications, especially for early detection and intervention (see Rudman et al., Abstract. [0003]).
Claims 11-13, 15, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al. and McCord et al. as applied to claim 1 above, and further in view of Kainz et al. ("Eliminating viscosity bias in lateral flow tests", as cited by the IDS).
Regarding claim 11, the combination of Erickson et al. and McCord et al. fails to teach the method further including a buffering solution for use in adjusting saliva viscosity for use with the test card.
However, in the analogous art of "Eliminating viscosity bias in lateral flow tests", Kainz et al. teaches lateral flow tests using saliva, where it is noted that saliva is known to show large variations in viscosity. Equalization of sample viscosities can be done using a dilution buffer with a specific viscosity (see Kainz et al., Introduction, pg. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test card of the combination of Erickson et al. and McCord et al. by incorporating a buffer for equalizing the saliva sample viscosity (as taught by Kainz et al), for the benefit of reducing viscosity bias of signal intensities for improved lateral flow tests (see Kainz et al., Introduction, pg. 1).
Regarding claim 12 the combination of Erickson et al. and McCord et al. fails to teach wherein the buffering solution is compatible with all of the biomarkers.
However, Kainz et al. teaches the sample buffer comprising phosphate buffered saline, 3% heat-shocked bovine serum albumin, and 1% Tween-20, with additional gold nanoparticle additives (see Kainz et al., pg. 8, Lateral flow assay and processing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis of bodily fluids and test card of the combination of Erickson et al. and McCord et al. by incorporating a similar buffering solution as used in the instant application (see instant spec [0078], 1x phosphate buffered saline (PBS), 1% Ten-20, and 2% bovine serum albumin (BSA)), as a universal running buffer solution) which uses PBS, Tween-20 and bovine serum albumin (as taught by Kainz et al.), for the benefit of reducing viscosity bias of signal intensities for improved lateral flow tests (see Kainz et al., Introduction, pg. 1).
Regarding claim 13, the combination of Erickson et al. and McCord et al. fails to teach wherein the buffering solution consists of 1x phosphate buffered saline and 1% Ten-20, and 2% bovine serum albumin.
However, Kainz et al. teaches the sample buffer comprising phosphate buffered saline, 3% heat-shocked bovine serum albumin, and 1% Tween-20, with additional gold nanoparticle additives (see Kainz et al., pg. 8, Lateral flow assay and processing).
While Kainz et al. doesn't explicitly teach wherein the buffering solution consists of 1x phosphate buffered saline and 2% bovine serum albumin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the buffering solution consisting of 1x phosphate buffered saline and 2% bovine serum albumin, as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Furthermore, It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis and test card of the combination of Erickson et al. and McCord et al. to incorporate the buffering solution consisting of 1x phosphate buffered saline and 1% Tween-20, and 2% bovine serum albumin (as taught by Kainz et al), for the benefit of reducing viscosity bias of signal intensities for improved lateral flow tests (see Kainz et al., Introduction, pg. 1).
Regarding claim 15, Erickson et al. teaches a point-of-collection device, with selected quantitative indicia of an analyte on a test strip using a smartphone involves imaging a test strip on which a colorimetric reaction of a target sample has occurred due to test strip illumination by the smartphone. This includes a quantitative analyses of bodily fluids like saliva, where it may contain indicators of pH and calcium concentrations for determining dental hygiene and health, as well as determining if periodontitis is present (see Erickson et al., Abstract, [0016], [0138]). The use of smartphone solutions is contemplated as portable diagnostic devices, with a mReader software installed onto the system to allow for reading lateral flow tests by analyzing test strip images taken from the smartphone cameras. Such test strips are a disposable lateral flow immunochromatographic test strip (see Erickson et al., [0004]-[0005], [0050]).
However, McCord et al. teaches a card containing multiple tests that can have a bodily fluid sample applied, such as saliva, where the card can have its image captured by a phone for analysis performed by it to determine test results. The test card includes test regions, may include colorimetric tests and lateral flow assays, where the lateral flow assay regions are 202b through 202e (see McCord et al., Abstract, [0001], [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the point-of-collection device as the test kit of Erickson et al. by incorporating test cards with a plurality of lateral flow strips (as taught by McCord et al.), for the benefit of multiple analyte detection that is capable of adjusting for variable lighting conditions and timing (see McCord et al., [0001]).
However, the combination of Erickson et al. and McCord et al. fails to teach that the kit further including a buffering solution compatible with all biomarkers related to dental caries, periodontal disease, halitosis, Sjogren's Syndrome and candida.
However, Kainz et al. teaches the sample buffer comprising phosphate buffered saline, 3% heat-shocked bovine serum albumin, and 1% Tween-20, with additional gold nanoparticle additives (see Kainz et al., pg. 8, Lateral flow assay and processing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the point-of-collection kit and test card of the combination of Erickson et al. and McCord et al. by incorporating a similar buffering solution as used in the instant application (see instant spec [0078], 1x phosphate buffered saline (PBS), 1% Ten-20, and 2% bovine serum albumin (BSA)), as a universal running buffer solution, also see claim 13 rejection) which uses PBS, Tween-20 and bovine serum albumin (as taught by Kainz et al.), for the benefit of reducing viscosity bias of signal intensities for improved lateral flow tests (see Kainz et al., Introduction, pg. 1).
Regarding claim 19, the combination of Erickson et al. and McCord et al. teaches wherein the buffering solution consists of 1x phosphate buffered saline (PBS) and 1% Ten-20, and 2% bovine serum albumin.
However, Kainz et al. teaches the sample buffer comprising phosphate buffered saline, 3% heat-shocked bovine serum albumin, and 1% Tween-20, with additional gold nanoparticle additives (see Kainz et al., pg. 8, Lateral flow assay and processing).
While Kainz et al. doesn't explicitly teach wherein the buffering solution consists of 1x phosphate buffered saline and 2% bovine serum albumin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the buffering solution comprise 1x phosphate buffered saline and 2% bovine serum albumin, as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). Furthermore, It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis and test card of the combination of Erickson et al. and McCord et al. to incorporate the buffering solution consisting of 1x phosphate buffered saline and 1% Tween-20, and 2% bovine serum albumin (as taught by Kainz et al), for the benefit of reducing viscosity bias of signal intensities for improved lateral flow tests (see Kainz et al., Introduction, pg. 1).
Regarding claim 21, the combination of Erickson et al. and Kainz et al. fails to teach wherein the test card includes a front side, the front side including apertures for placement saliva, test strip visualization, and color visualization, the front side further including a color wheel.
However, Mccord et al. teaches a test card containing multiple tests that can have a bodily fluid sample applied. The test card 100 includes test regions, which further may include colorimetric tests and lateral flow assays. The test card may also contain color fiducials for color correction, and one or more-time indicators for timing correction. These test regions, including the lateral flow assay regions 202b through 202e, the colorimetric test regions 203a through 205f are arranged on the top of the test card as seen in Fig. 2. The lateral flow assay regions additionally receive sample corresponding pads 201b, 201c, 201d, and 201e. (see McCord et al., Abstract, Fig. 2, [0001], [0033], [0040]-[0041]). Each test region may contain reagents or combinations of reagents that react with specific elements that may be present in a urine sample to generate a visible change in the appearance of the test region. The test card 100 also contains two rows of color fiducial markers such as 221a and 221b at the top of the image in FIG. 2, and 221c and 221d at the bottom of the image in FIG. 2 (see McCord et al., Fig. 2, [0040], [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quantitative analysis of bodily fluids of Erickson et al. and Kainz et al. to incorporate a card comprising on the top side of it having a lateral flow assay and colorimetric assay, which has additional apertures for obtaining the sample, visualization of changes in test strip, and color markings on the test card (as taught by McCord et al.), for the benefit of providing multiple analyte detection on the test card by having all the assays and apertures arranged on the front side, where this enables adjusting for variable lighting conditions and timing when capturing an image with a smartphone (see McCord et al., [0001], [0003]).
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al., McCord et al., and Kainz et al. as applied to claim 11 and 15 above, and further in view of Buzhuo et al. (WO 2018120854 A1).
Regarding claim 14, the combination of Erickson et al., McCord et al. and Kainz et al. fails to teach wherein the buffering solution consists of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin.
However, in the analogous art of time-resolved fluorescent immunochromatographic test trips and kits, Buzhuo et al. teaches a double-antibody sandwich immunochemiluminescence assay in the detection of a creatine kinase isoenzyme. The buffer consisting of 0.02 mol/L boric acid, 0.5% BSA, and 0.05% Tween-20 was used for reconstitution (see Buzhuo et al., [0002], [0004], [0046], noting the automatic translation for boric acid buffer is incorrectly referred as borate acid.).
While Buzhou et al. doesn’t explicitly teach wherein the buffering solution consists of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the buffering solution consist of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Additionally, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the buffer for adjusting saliva viscosity of the combination of Erickson et al., McCord et al., and Kainz et al. by incorporating the buffering solution consisting of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin (as taught by Buzhou et al.), for the benefit of equalizing saliva viscosity for improved detection of biomarkers through lateral flow assays.
Regarding claim 20, the combination of Erickson et al., McCord et al. and Kainz et al. fails to teach wherein the buffering solution consists of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin.
However, Buzhuo et al. teaches a double-antibody sandwich immunochemiluminescence assay in the detection of a creatine kinase isoenzyme. The buffer consisting of 0.02 mol/L boric acid, 0.5% BSA, and 0.05% Tween-20 was used for reconstitution (see Buzhuo et al., [0002], [0004], [0046], noting the automatic translation for boric acid buffer is incorrectly referred as borate acid.).
While Buzhou et al. doesn’t explicitly teach wherein the buffering solution consists of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the buffering solution consist of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Additionally, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the buffer for adjusting saliva viscosity of the combination of Erickson et al., McCord et al., and Kainz et al. by incorporating the buffering solution consisting of 50 nM boric acid (pH 9.0) and 1% Ten-20, and 2% Bovine Serum Albumin (as taught by Buzhou et al.), for the benefit of equalizing saliva viscosity for improved detection of biomarkers through lateral flow assays.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al., McCord et al., and Kainz et al. as applied to claim 15 above, and further in view of Chou et al. (US PG-Pub 20210072122 A1).
Regarding claim 16, the combination of Erickson et al., McCord et al., and Kainz et al. fails to teach wherein the solution is screened for specific antibodies including antibodies for Glucosyltransferase, dipeptidyl peptidase, Atopobium parvulum, Eubacterium sulci, Fusobacterium periodonticum and Solobacterium moorei.
However, Chou et al. teaches using a compressed regulated open flow device that includes a plurality of capture agents that each bind to a plurality of analytes in a sample, of which includes dipeptidyl-peptidase 4 (CD26, adenosine deaminase complexing protein 2) (see Chou et al., Table 2B, [0967]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biomarker of the combination of Erickson et al., McCord et al. and Kainz et al to incorporate the binding agent dipeptidyl-peptidase 4 as a biomarker (as taught by Chou et al.), for the benefit being able to use a bio/chemical sensor in detecting biomarkers associated with dental or oral diseases and conditions.
Regarding claim 17, the combination of Erickson et al., Mccord et al., and Kainz et al. fails to teach wherein the dipeptidyl peptidase is dipeptidyl peptidase-4/CD26.
However, Chou et al. teaches using a compressed regulated open flow device that includes a plurality of capture agents that each bind to a plurality of analytes in a sample, of which includes dipeptidyl-peptidase 4 (CD26, adenosine deaminase complexing protein 2) (see Chou et al., Table 2B, [0967]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biomarker of the combination of Erickson et al., McCord et al. and Kainz et al to incorporate the binding agent dipeptidyl-peptidase 4/CD26 as a biomarker (as taught by Chou et al.), for the benefit being able to use a bio/chemical sensor in detecting biomarkers associated with dental or oral diseases and conditions.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Erickson et al., McCord et al., Kainz et al., and Chou et al. as applied to claim1 4 above, and further in view of Garreto et al.
Regarding claim 18, the combination of Erickson et al., McCord et al., Kainz et al. and Chou et al. fails to teach wherein the dipeptidyl peptidase is the serine protease overexpressed in Sjogren's Syndrome.
However, Garreto et al. teaches an evaluation of differentially expressed proteases in Sjögren’s Syndrome Patients, where an increased activity of serine protease dipeptidyl peptidase-4/CD26 in primary Sjögren’s Syndrome saliva, the expression level of which was corroborated by ELISA assay (see Garreto et al., Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dipeptidyl peptidase of the combination of Erickson et al., McCord et al., Kainz et al., and Chou et al. to incorporate the increased expression of serine protease dipeptidyl peptidase-4/CD26 in primary Sjögren’s Syndrome saliva (as taught by Garreto et al.), for the benefit of non-invasive means of obtaining Sjögren’s Syndrome biomarkers in patients for diagnosis (see Garreto et al., Abstract).
Conclusion
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/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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