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 .
Response to Amendment
The Amendment filed 07/24/2026 has been entered. Claims 1-14 and 22-32 remain pending in the application. Claims 22-28 and 31-32 are withdrawn.
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.
Claim 14 is 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.
Regarding claim 14, claim 14 recites the limitation "the D-dimer testing zone", in line 25. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 and 29-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites the limitations “determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample”.
In accordance with MPEP 2106, the claims are found to recite statutory subject matter (Step 1: YES) and are analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A: Prong 1).
In the instant application, the limitations of “determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample” could be performed mentally or by math. Other than “processor”, if the claim limitations, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components (e.g. processor), then the claim limitations fall within the “Mental Processes” grouping of abstract ideas (MPEP 2106.05(f)). Accordingly, the claims recite abstract ideas (Step 2A: Prong 1: Yes).
This judicial exception is not integrated into a practical application because the claims do not recite any additional elements that reflects an improvement to technology or applies or uses the judicial exception in some other meaningful way (Step 2A, Prong 2: No). In claim 1, after the limitation of “determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample”, no further action is performed. Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The processor limitations are recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claims are directed to an abstract idea that is not integrated into a practical application (Step 2A, Prong 2: No).
The claims 1-14 and 29-30 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding the abstract idea, claim 1 merely recites the processor, wherein the claimed limitations of the processor amount to no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Claim 1 and dependent claims 2-14 and 29-30 further recites limitations, however these limitations generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering or data outputting, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)), which alone or in combination do not amount to significantly more. Additionally, the limitations of claims 1-14 and 29-30 are well-understood, routine and conventional activities as evidenced by the prior art of: Tu et al. (US 20210285977 A1; effectively filed 06/23/2017), Nahm et al. (US 20050214951 A1), Lee et al. (LEE, Y. J., et al., "Optimization of Saliva Collection and Immunochromatographic Detection of Salivary Pepsin for Point-of-Care Testing of Laryngopharyngeal Reflux," Sensors, 2020, 20(1): 325; cited in the IDS filed 12/23/2021), BIOSYNEX (BIOSYNEX D-dimer User Guide, Version 04 EN 03/20; cited in the IDS filed 12/23/2021), and Du et al. (Du et al., “The diagnostic value of pepsin detection in saliva for gastro-esophageal reflux disease: a preliminary study from China”, BMC Gastroenterology, 2017, 17:107). See MPEP 2106.05(d). The additional elements of the claims 1-14 and 29-30 do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). The claims are not patent eligible.
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.
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.
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.
Claims 1-2, 6, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Tu et al. (US 20210285977 A1; effectively filed 06/23/2017) in view of Nahm et al. (US 20050214951 A1).
Regarding claim 1, Tu teaches an apparatus (Figs. 1A-18; abstract) comprising:
a saliva specimen holder (Figs. 1C, 2, and 5A-5B, one of the test cartridges 200; [0013] teaches the cartridge can store a patient sample and includes a test strip; therefore, the cartridge is capable of holding a saliva specimen via the cartridge and test strip) configured to collect a saliva sample (Figs. 1C, 2, and 5A-5B, one of the test cartridges 200; [0013] teaches the cartridge can store a patient sample and includes a test strip, which is structurally capable of collecting a saliva sample; [0068] teaches saliva samples);
a blood specimen holder (Figs. 1C, 2, and 5A-5B, another one of the test cartridges 200; [0013] teaches the cartridge can store a patient sample and includes a test strip; therefore, the cartridge is capable of holding a blood specimen via the cartridge and test strip) configured to collect a blood sample (Figs. 1C, 2, and 5A-5B, one of the test cartridges 200; [0013] teaches the cartridge can store a patient sample and includes a test strip, which is structurally capable of collecting a blood sample; [0113] and [0197] teaches blood samples); and
a processor ([0072] “microprocessor”).
Tu fails to teach: the processor programmed to determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample.
Tu teaches a need for testing samples for biomarkers indicative of medical conditions and automatically facilitate the parallel processing of multiple colorimetric-based or fluorescent-based lateral flow immunoassay test strips or chemistry-based test strips for automated testing at the point-of-care ([0011]). Tu teaches the system including a processor configured to execute instructions to analyze an image of a test strip to indicate one or more patient conditions ([0013]). Tu teaches the device may be configured to perform different types of tests ([0072]) and a plurality of test cartridges for different test types ([0184]). Tu teaches a plurality of types of test cartridges or test strips usable to test for a plurality of different patient conditions ([0322]). Tu teaches patient samples can include saliva and blood ([0153],[0170], [0197]).
Nahm teaches a lateral flow quantitative assay method which can measure one or more analyte species at the same time with high sensitivity, the method includes using a lateral flow assay strip (abstract). Nahm teaches various analytes to be analyzed in a liquid sample, such as blood and saliva ([0054]), includes D-dimer ([0066]) and pepsin ([0088]). Nahm teaches all of these proteins can be quantified by the package comprising the lateral flow assay strip ([0088]). Nahm teaches it would be advantageous in terms of economic aspects and other aspects to provide a method capable of rapidly and precisely quantifying different kinds of analytes at the same time, to satisfy demands of both general consumers and those involved in medical fields for development of such products ([0010]). Nahm teaches a label which can act as an indicator of presence or absence of an analyte in a liquid sample ([0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Tu to incorporate Tu’s teachings of a need for testing samples for biomarkers indicative of medical conditions and automatically facilitating parallel processing and testing of test strips ([0011]), the processor analyzing test cartridges for multiple different patient conditions ([0013],[0072],[0184], [0322]), and samples includes saliva and blood ([0153],[0170],[0197]) and Nahm’s teachings of measuring multiple analyte species using lateral flow assays ([abstract; [0010],[0088]), analytes of blood and saliva can include D-dimer and pepsin ([0054],[0066],[0088]) and a label acting as an indicator for an analyte in the sample ([0099]) to provide: the processor programmed to determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample. Doing so would have a reasonable expectation of successfully improving throughput, automation, and efficiency of detecting and quantifying different kinds of desired analytes (i.e. D-dimer and pepsin), therefore allowing for improved analysis of different medical conditions of a patient.
Furthermore, since Tu teaches a need for testing samples for biomarkers indicative of medical conditions from multiple test strips and Nahm teaches a finite number of identified, predictable types of analytes to analyze, e.g. D-dimer and pepsin, it would have been obvious to have modified the processor to choose D-dimer and pepsin from a finite number of identified, predictable analytes for analysis as discussed by Nahm ([0066],[0088],[0099]) to provide: the processor programmed to determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample. I.e., it would have been obvious to try the specific processor programmed to determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample to improve analysis of different kinds of desired analytes with a reasonable expectation of success. See MPEP 2143(I)(E).
Regarding claim 2, Tu further teaches the apparatus of claim 1, further comprising a housing (Figs. 1-2; shell 101 of kiosk 110) and
wherein the saliva specimen holder (Figs. 1C, 2, and 5A-5B, one of the test cartridges 200) is disposable (Fig. 1C and [0131] teaches cartridges are disposable) and comprises a collection well mounted on a holder (Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto),
the collection well configured to collect an amount of a saliva sample from a patient (interpreted as a functional limitation, see MPEP 2114; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto; [0068] teaches saliva samples; therefore, the sample well is structurally capable of collecting a saliva sample); and
wherein the housing includes an input port (Fig. 1A and 2, test cartridge insertion port 104) configured to receive the collection well of the saliva specimen holder (interpreted as a functional limitation, see MPEP 2114; Figs. 1-2 and [0138] teaches the test cartridge insertion port 104 enables insertion of the cartridge; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well; therefore, the insertion port 104 is configured to receive the test strip sample well of the test cartridge).
Regarding claim 6, Tu further teaches the apparatus of claim 1, further comprising a housing (Figs. 1-2; shell 101 of kiosk 110) and
wherein the blood specimen holder (Figs. 1C, 2, and 5A-5B, another one of the test cartridges 200) is a disposable cassette (Fig. 1C and [0131] teaches cartridges, i.e. cassette, are disposable), and
wherein the housing includes an input port (Fig. 1A and 2, test cartridge insertion port 104) configured to receive at least the portion of the disposable cassette that includes a testing zone (interpreted as a functional limitation, see MPEP 2114; Figs. 1-2 and [0138] teaches the test cartridge insertion port 104 enables insertion of the cartridge; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well; [0084] teaches the test strip includes test lines, i.e. testing zone; therefore, the insertion port 104 is configured to receive the test cartridge, i.e. cassette, that includes a testing zone).
Modified Tu fails to teach the testing zone is a pepsin testing zone.
Nahm teaches a lateral flow quantitative assay method which can measure one or more analyte species at the same time with high sensitivity, the method includes using a lateral flow assay strip (abstract). Nahm teaches various analytes to be analyzed in a liquid sample, such as blood and saliva ([0054]), includes D-dimer ([0066]) and pepsin ([0088]). Nahm teaches all of these proteins can be quantified by the package comprising the lateral flow assay strip ([0088]). Nahm teaches it would be advantageous in terms of economic aspects and other aspects to provide a method capable of rapidly and precisely quantifying different kinds of analytes at the same time, to satisfy demands of both general consumers and those involved in medical fields for development of such products ([0010]). Nahm teaches a label which can act as an indicator of presence or absence of an analyte in a liquid sample ([0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disposable cassette and testing zone of modified Tu to incorporate Nahm’s teachings of measuring multiple analyte species using lateral flow assays ([abstract; [0010],[0088]), analytes can include pepsin ([0054],[0066],[0088]) and a label acting as an indicator for an analyte in the sample ([0099]) to provide: the testing zone is a pepsin testing zone. Doing so would have a reasonable expectation of successfully improving throughput, automation, and efficiency of detecting and quantifying different kinds of desired analytes (i.e. pepsin), therefore allowing for improved analysis of different medical conditions of a patient.
Furthermore, since Tu teaches a need for testing samples for biomarkers indicative of medical conditions from multiple test strips and Nahm teaches a finite number of identified, predictable types of analytes to analyze, e.g. pepsin, it would have been obvious to have modified the testing zone pepsin from a finite number of identified, predictable analytes for analysis as discussed by Nahm ([0066],[0088],[0099]) to provide: the testing zone is a pepsin testing zone. I.e., it would have been obvious to try the specific the testing zone as a pepsin testing zone to improve analysis of different kinds of desired analytes with a reasonable expectation of success. See MPEP 2143(I)(E).
Regarding claim 29, Tu further teaches the apparatus of claim 1, further comprising a display (Fig. 2, display 102) configured to display graphical and/or textual information ([0013],[0087]).
Modified Tu fails to teach: wherein the processor is further programmed to send information to the display indicating whether or not the pepsin was detected and/or whether or not the pepsin was detected above a threshold level.
Tu teaches the system including a processor configured to execute instructions to analyze an image of a test strip to indicate one or more patient conditions ([0013]). Tu teaches geometric image processing algorithms processing optical images of the test strips and determining the local maxima of test strip lines, integrate their color values, and compare the integrated results to thresholds ([0084]). Tu teaches if the change in pixel intensity is stronger than a threshold on both sides of the test result line, the algorithm reports the detection of the test result line and a positive result ([0085]). Tu teaches the device is configured to display the results on the display ([0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of modified Tu to incorporate the teachings of image processing of a test strip to determine if a test line has a positive result based on a threshold and displaying results on a display of Tu to provide: wherein the processor is further programmed to send information to the display indicating whether or not the pepsin was detected and/or whether or not the pepsin was detected above a threshold level. Doing so would have a reasonable expectation of successfully improving determination of a positive result based on image processing.
Claims 3-5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Nahm as applied to claim 1 above, and further in view of Lee et al. (LEE, Y. J., et al., "Optimization of Saliva Collection and Immunochromatographic Detection of Salivary Pepsin for Point-of-Care Testing of Laryngopharyngeal Reflux," Sensors, 2020, 20(1): 325; cited in the IDS filed 12/23/2021).
Regarding claim 3, Tu further teaches the apparatus of claim 1, further comprising a housing (Figs. 1-2; shell 101 of kiosk 110) and
wherein the saliva specimen holder (Figs. 1C, 2, and 5A-5B, one of the test cartridges 200) is disposable (Fig. 1C and [0131] teaches cartridges are disposable) and comprises a collection well (Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto) configured to receive a saliva sample (interpreted as a functional limitation, see MPEP 2114; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto; therefore, the sample well is structurally capable of collecting a saliva sample),
and wherein the housing includes an input port (Fig. 1A and 2, test cartridge insertion port 104) configured to receive at least a portion of the saliva specimen holder (interpreted as a functional limitation, see MPEP 2114; Figs. 1-2 and [0138] teaches the test cartridge insertion port 104 enables insertion of the cartridge; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well; therefore, the insertion port 104 is configured to receive the saliva specimen holder).
Modified Tu fails to teach: the saliva specimen holder comprises a first membrane in fluid communication with the collection well and a conjugate pad, the first membrane configured to fluidly communicate the saliva sample to the conjugate pad, the conjugate pad including an antibody conjugate configured to combine with pepsin contained in the saliva sample, the conjugate pad contacting a second membrane that is in fluid communication with a pepsin testing zone, the second membrane configured to fluidly communicate the combined saliva sample and antibody conjugate to the pepsin testing zone, the second membrane including a first composition at a first location on the membrane that is configured to interact with pepsin in the combined saliva sample and antibody conjugate and provide a first indicator when there is pepsin detected in the combined saliva sample and antibody conjugate; and a second composition at a second location spaced apart from the first location that is configured to interact with the combined saliva sample and antibody conjugate and provide a second indicator when the antibody conjugate is detected.
Tu teaches a need for testing samples for biomarkers indicative of medical conditions and automatically facilitate the parallel processing of multiple colorimetric-based or fluorescent-based lateral flow immunoassay test strips or chemistry-based test strips for automated testing at the point-of-care ([0011]). Tu teaches a test strip including pads for colorimetric analysis ([0086]). Tu teaches dispensing a sample into the test strip’s sample well (Fig. 13F; [0180]).
Lee teaches a test strip for detection of pepsin (abstract; Fig. 1). Lee teaches the test strip (Fig. 1) includes a first membrane (Fig. 1, sample pad) in fluid communication with a conjugate pad (Fig. 1), the first membrane configured to fluidly communicate a saliva sample to the conjugate pad (Fig. 1), the conjugate pad including an antibody conjugate (Fig. 1, AuNP-antibody conjugate) configured to combine with pepsin contained in the saliva sample (Fig. 1), the conjugate pad contacting a second membrane (Fig. 1, nitrocellulose membrane) that is in fluid communication with a pepsin testing zone (Fig. 1, test line), the second membrane configured to fluidly communicate the combined saliva sample and antibody conjugate to the pepsin testing zone (Fig. 1), the second membrane including a first composition (Fig. 1, anti-pepsin antibody) at a first location on the membrane (Fig. 1, test line) that is configured to interact with pepsin in the combined saliva sample and antibody conjugate and provide a first indicator when there is pepsin detected in the combined saliva sample and antibody conjugate (Fig. 1 teaches the AuNP-antibody conjugate binds to pepsin to provide a colorimetric intensity); and a second composition (Fig. 1, anti-rabbit antibody) at a second location spaced apart from the first location (Fig. 1, control line) that is configured to interact with the combined saliva sample and antibody conjugate and provide a second indicator when the antibody conjugate is detected (Fig. 1 teaches the AuNP-antibody conjugate binds to the anti-rabbit antibody to provide a color). Lee teaches salivary pepsin is a promising marker for the non-invasive diagnosis of LPR and the test strip provides for good sensitivity to pepsin in real saliva samples and allows for distinguishing between healthy control and LPR patients based on the color changes in the pepsin immunochromatographic strip (pages 10-12, section 4 “Conclusions”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the saliva specimen holder of modified Tu to incorporate Tu’s teachings of test strips including pads and a sample well ([0086]; [0180]) and Lee’s teachings of a test strip for detection of pepsin including a first membrane, conjugate pad, second membrane, a test line, and control line (Fig. 1; abstract) to provide: the saliva specimen holder comprises a first membrane in fluid communication with the collection well and a conjugate pad, the first membrane configured to fluidly communicate the saliva sample to the conjugate pad, the conjugate pad including an antibody conjugate (i.e. AuNP-antibody conjugate) configured to combine with pepsin contained in the saliva sample, the conjugate pad contacting a second membrane that is in fluid communication with a pepsin testing zone, the second membrane configured to fluidly communicate the combined saliva sample and antibody conjugate to the pepsin testing zone, the second membrane including a first composition at a first location on the membrane that is configured to interact with pepsin in the combined saliva sample and antibody conjugate and provide a first indicator when there is pepsin detected in the combined saliva sample and antibody conjugate; and a second composition at a second location spaced apart from the first location that is configured to interact with the combined saliva sample and antibody conjugate and provide a second indicator when the antibody conjugate is detected. Doing so would have a reasonable expectation of successfully improving sensitivity and diagnostic of pepsin from the saliva specimen holder as taught by Lee (pages 10-12, section 4 “Conclusions”).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the claimed saliva specimen holder including a first membrane, collection well, conjugate pad, second membrane, antibody conjugate, first composition, and second composition) by known methods with no change in their respective functions (i.e. sample processing and detection of pepsin), and the combinations yielded nothing more than predictable results (i.e. providing the claimed structure of the saliva specimen holder would yield nothing more than the obvious and predictable result of enabling diagnostic of pepsin from the saliva specimen holder as taught by Lee, pages 10-12, section 4 “Conclusions”). See MPEP 2143(A).
Regarding claim 4, Tu further teaches the apparatus of claim 3, further comprising a display (Fig. 2, display 102) configured to display graphical and/or textual information ([0013],[0087]),
wherein the housing includes an imager (Figs. 1B, 1C, 8 and [0013],[0072],[0081] teaches an imaging system 9) connected to the processor ([0013]), the imager positioned to monitor the pepsin testing zone when the saliva specimen holder is inserted into the input port and provide image data to the processor (interpreted as a functional limitation, see MPEP 2114; [0013] teaches the imaging system is configured to capture an image of the test strip and the processor receives the image of the test strip for analysis; therefore, the imaging system is capable of monitoring the pepsin testing zone when the saliva specimen holder is inserted into the insertion port 104 of the system and provide the image data to the processor for analysis).
Modified Tu fails to teach: wherein the processor is programmed to detect the presence of the first or second indicator, the processor programmed to provide information to the display indicative of whether or not the first or second indicator has been detected.
Lee teaches the colorimetric intensity at the test line, i.e. first indicator, which corresponds to the amount of pepsin in saliva samples, is captured using a digital camera and analyzed using ImageJ software; and the appearance of color at the control line, i.e. second indicator, ensures that a strip is functioning correctly (Fig. 1). Lee teaches salivary pepsin is a promising marker for the non-invasive diagnosis of LPR and the test strip provides for good sensitivity to pepsin in real saliva samples and allows for distinguishing between healthy control and LPR patients based on the color changes in the pepsin immunochromatographic strip (pages 10-12, section 4 “Conclusions”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of modified Tu to incorporate Lee’s teachings of imaging and analyzing indicators of a test line and control line (Fig. 1) to provide: wherein the processor is programmed to detect the presence of the first or second indicator, the processor programmed to provide information to the display indicative of whether or not the first or second indicator has been detected. Doing so would have a reasonable expectation of successfully improving sensitivity of detection of pepsin in saliva samples and ensuring the strip is functioning correctly.
Regarding claim 5, modified Tu further teaches the apparatus of claim 4, wherein the antibody conjugate is a AuNP-antibody conjugate (see above claim 3; modified Tu in combination with Lee provides the AuNP-antibody conjugate; Lee, Fig. 1 teaches an AuNP-antibody conjugate).
Regarding claim 14, Tu further teaches the apparatus of claim 1, further comprising:
a display (Fig. 2, display 102) configured to display graphical and/or textual information ([0013],[0087]); and
a housing (Figs. 1-2; shell 101 of kiosk 110) that includes at least one input port (Fig. 1A and 2, test cartridge insertion port 104);
wherein the saliva specimen holder is a disposable cassette (Fig. 1C and [0131] teaches cartridges are disposable) and includes a collection well (Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto) configured to receive a saliva sample (interpreted as a functional limitation, see MPEP 2114; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto; [0068] teaches saliva samples; therefore, the sample well is structurally capable of collecting a saliva sample),
wherein the input port is configured to receive at least a portion of the disposable cassette (interpreted as a functional limitation, see MPEP 2114; Figs. 1-2 and [0138] teaches the test cartridge insertion port 104 enables insertion of the cartridge; therefore, the insertion port 104 is configured to receive the disposable cassette);
wherein the blood sample holder is the disposable cassette (Fig. 1C and [0131] teaches cartridges, i.e. cassette, are disposable); and
wherein the housing includes an imager (Figs. 1B, 1C, 8 and [0013],[0072],[0081] teaches an imaging system 9) connected to the processor ([0013]), and
the imager configured to send image data to the processor (interpreted as a functional limitation, see MPEP 2114; [0013] teaches the imaging system is configured to capture an image of the test strip and the processor receives the image of the test strip for analysis; therefore, the imaging system is configured to send image data to the processor for analysis),
the imager configured to monitor the pepsin testing zone when the disposable cassette containing the saliva sample is inserted into the at least one input port (interpreted as a functional limitation, see MPEP 2114; [0013] teaches the imaging system is configured to capture an image of the test strip and the processor receives the image of the test strip for analysis; therefore, the imaging system is capable of monitoring the pepsin testing zone when a saliva specimen holder is inserted into the insertion port 104 of the system and provide the image data to the processor for analysis) and to monitor the D-dimer testing zone when the disposable cassette containing the blood sample is inserted into the at least one input port (interpreted as a functional limitation, see MPEP 2114; [0013] teaches the imaging system is configured to capture an image of the test strip and the processor receives the image of the test strip for analysis; therefore, the imaging system is capable of monitoring the D-dimer testing zone when the cassette containing the blood sample is inserted into the insertion port 104 of the system and provide the image data to the processor for analysis).
Modified Tu fails to teach: the saliva specimen holder includes a first membrane in fluid communication with the collection well and a conjugate pad, the first membrane configured to fluidly communicate the saliva sample to the conjugate pad, the conjugate pad including an antibody conjugate configured to combine with pepsin contained in the saliva sample, the conjugate pad contacting a second membrane that is in fluid communication with a pepsin testing zone, the second membrane configured to fluidly communicate the combined saliva sample and antibody conjugate to the pepsin testing zone, the second membrane including a first composition at a first location on the membrane that is configured to interact with pepsin in the combined saliva sample and antibody conjugate and provide an indicator when there is pepsin detected in the combined saliva sample and antibody conjugate; and a second composition at a second location spaced apart from the first location that is configured to interact with the combined saliva sample and antibody conjugate and provide an indicator when the antibody conjugate is detected; and wherein the processor is programmed to detect the presence of an indicator in the image data, the processor programmed to provide information to the display indicative of whether or not the indicator in the image data has been detected in the image data.
Tu teaches a need for testing samples for biomarkers indicative of medical conditions and automatically facilitate the parallel processing of multiple colorimetric-based or fluorescent-based lateral flow immunoassay test strips or chemistry-based test strips for automated testing at the point-of-care ([0011]). Tu teaches the system including a processor configured to execute instructions to analyze an image of a test strip to indicate one or more patient conditions ([0013]). Tu teaches a test strip including pads for colorimetric analysis ([0086]). Tu teaches dispensing a sample into the test strip’s sample well (Fig. 13F; [0180]).
Lee teaches a test strip for detection of pepsin (abstract; Fig. 1). Lee teaches the test strip (Fig. 1) includes a first membrane (Fig. 1, sample pad) in fluid communication with a conjugate pad (Fig. 1), the first membrane configured to fluidly communicate a saliva sample to the conjugate pad (Fig. 1), the conjugate pad including an antibody conjugate (Fig. 1, AuNP-antibody conjugate) configured to combine with pepsin contained in the saliva sample (Fig. 1), the conjugate pad contacting a second membrane (Fig. 1, nitrocellulose membrane) that is in fluid communication with a pepsin testing zone (Fig. 1, test line), the second membrane configured to fluidly communicate the combined saliva sample and antibody conjugate to the pepsin testing zone (Fig. 1), the second membrane including a first composition (Fig. 1, anti-pepsin antibody) at a first location on the membrane (Fig. 1, test line) that is configured to interact with pepsin in the combined saliva sample and antibody conjugate and provide a first indicator when there is pepsin detected in the combined saliva sample and antibody conjugate (Fig. 1 teaches the AuNP-antibody conjugate binds to pepsin to provide a colorimetric intensity); and a second composition (Fig. 1, anti-rabbit antibody) at a second location spaced apart from the first location (Fig. 1, control line) that is configured to interact with the combined saliva sample and antibody conjugate and provide a second indicator when the antibody conjugate is detected (Fig. 1 teaches the AuNP-antibody conjugate binds to the anti-rabbit antibody to provide a color). Lee teaches the colorimetric intensity at the test line, i.e. first indicator, which corresponds to the amount of pepsin in saliva samples, is captured using a digital camera and analyzed using ImageJ software; and the appearance of color at the control line, i.e. second indicator, ensures that a strip is functioning correctly (Fig. 1). Lee teaches salivary pepsin is a promising marker for the non-invasive diagnosis of LPR and the test strip provides for good sensitivity to pepsin in real saliva samples and allows for distinguishing between healthy control and LPR patients based on the color changes in the pepsin immunochromatographic strip (pages 10-12, section 4 “Conclusions”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the saliva specimen holder of modified Tu to incorporate Tu’s teachings of test strips including pads and a sample well ([0086]; [0180]) and Lee’s teachings of a test strip for detection of pepsin including a first membrane, conjugate pad, second membrane, a test line, and control line (Fig. 1; abstract) and imaging and analyzing indicators of a test line and control line (Fig. 1) to provide: the saliva specimen holder includes a first membrane in fluid communication with the collection well and a conjugate pad, the first membrane configured to fluidly communicate the saliva sample to the conjugate pad, the conjugate pad including an antibody conjugate configured to combine with pepsin contained in the saliva sample, the conjugate pad contacting a second membrane that is in fluid communication with a pepsin testing zone, the second membrane configured to fluidly communicate the combined saliva sample and antibody conjugate to the pepsin testing zone, the second membrane including a first composition at a first location on the membrane that is configured to interact with pepsin in the combined saliva sample and antibody conjugate and provide an indicator when there is pepsin detected in the combined saliva sample and antibody conjugate; and a second composition at a second location spaced apart from the first location that is configured to interact with the combined saliva sample and antibody conjugate and provide an indicator when the antibody conjugate is detected; and wherein the processor is programmed to detect the presence of an indicator in the image data, the processor programmed to provide information to the display indicative of whether or not the indicator in the image data has been detected in the image data. Doing so would have a reasonable expectation of successfully improving sensitivity and diagnostic of pepsin from the saliva specimen holder as taught by Lee (pages 10-12, section 4 “Conclusions”). Furthermore, doing so would have a reasonable expectation of successfully improving image processing and automation of detecting the presence of the indicator.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the claimed saliva specimen holder including a first membrane, collection well, conjugate pad, second membrane, antibody conjugate, first composition, and second composition) by known methods with no change in their respective functions (i.e. sample processing and detection of pepsin), and the combinations yielded nothing more than predictable results (i.e. providing the claimed structure of the saliva specimen holder would yield nothing more than the obvious and predictable result of enabling diagnostic of pepsin from the saliva specimen holder as taught by Lee, pages 10-12, section 4 “Conclusions”). See MPEP 2143(A).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Nahm as applied to claim 6 above, and further in view of BIOSYNEX (BIOSYNEX D-dimer User Guide, Version 04 EN 03/20; cited in the IDS filed 12/23/2021).
Regarding claim 7, Tu further teaches the apparatus of claim 6, further comprising a display (Fig. 2, display 102) configured to display graphical and/or textual information ([0013],[0087]), and
the apparatus further comprising an imager (Figs. 1B, 1C, 8 and [0013],[0072],[0081] teaches an imaging system 9) connected to the processor ([0013]), the imager configured to monitor the testing zone when the disposable cassette is inserted into the input port and provide image data to the processor (interpreted as a functional limitation, see MPEP 2114; [0013] teaches the imaging system is configured to capture an image of the test strip and the processor receives the image of the test strip for analysis; therefore, the imaging system is capable of monitoring the testing zone when the cassette is inserted into the insertion port 104 of the system and provide the image data to the processor for analysis),
wherein the blood specimen holder comprises a well (Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto) configured to collect the blood sample (interpreted as a functional limitation, see MPEP 2114; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto; [0113] and [0197] teaches blood samples; therefore, the sample well is structurally capable of collecting a blood sample).
Modified Tu fails to teach the blood specimen holder comprises a D-dimer testing zone, and a membrane in fluid communication with the well and the D-dimer testing zone, the membrane configured to fluidly communicate the blood sample to the D-dimer testing zone, wherein a composition on the membrane in the D-dimer testing zone is configured, when mixed with blood containing a D-dimer protein, to provide an indicator; and wherein the processor is programmed to detect the presence of the indicator, the processor programmed to provide information to the display indicative of whether or not the indicator has been detected.
Tu teaches a need for testing samples for biomarkers indicative of medical conditions and automatically facilitate the parallel processing of multiple colorimetric-based or fluorescent-based lateral flow immunoassay test strips or chemistry-based test strips for automated testing at the point-of-care ([0011]). Tu teaches the system including a processor configured to execute instructions to analyze an image of a test strip to indicate one or more patient conditions ([0013]). Tu teaches the device may be configured to perform different types of tests ([0072]) and a plurality of test cartridges for different test types ([0184]). Tu teaches a plurality of types of test cartridges or test strips usable to test for a plurality of different patient conditions ([0322]). Tu teaches a test strip including pads for colorimetric analysis ([0086]). Tu teaches patient samples can include saliva and blood ([0153],[0170], [0197]).
BIOSYNEX teaches a D-dimer test using an immunochromatographic rapid test for detection of D-dimer in blood (page 1, left column, section “Intended Use”). BIOSYNEX teaches a blood specimen holder (page 1, left column, figure of the test device) comprises a sample well (page 1, left column, figure of the test device), a D-dimer testing zone (test line), and a membrane in fluid communication with the well and the D-dimer testing zone (membrane from the sample well to the test line), the membrane configured to fluidly communicate the blood sample to the D-dimer testing zone (page 1, left column, section “Principle”), wherein a composition on the membrane in the D-dimer testing zone is configured (page 1, left column, section “Principle”, teaches the test line region includes an color marked conjugate, i.e. anti-D-dimer antibody-gold conjugate), when mixed with blood containing a D-dimer protein, to provide an indicator (page 1, left column, section “Principle”, teaches the color marked anti-D-dimer provides a distinct color that indicates a positive result of D-dimer). BIOSYNEX teaches D-dimer concentration and testing may help in diagnosis of thrombosis (page 1, left column, section “Summary”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood specimen holder of modified Tu to incorporate Tu’s teachings testing biomarkers using multiple test strips ([001],[0013] ,[0322]), test strips including pads and a sample well ([0086]; [0180]) and imaging for colorimetric analysis ([0013],[0086]) and BIOSYNEX’s teachings of a D-dimer test cassette with a test strip with a test line, control line, membrane, and sample well (page 1, Left column, figure of the test device) to provide: the blood specimen holder comprises a D-dimer testing zone, and a membrane in fluid communication with the well and the D-dimer testing zone, the membrane configured to fluidly communicate the blood sample to the D-dimer testing zone, wherein a composition on the membrane in the D-dimer testing zone is configured, when mixed with blood containing a D-dimer protein, to provide an indicator; and wherein the processor is programmed to detect the presence of the indicator, the processor programmed to provide information to the display indicative of whether or not the indicator has been detected. Doing so would have a reasonable expectation of improving sensitivity and diagnostic of D-dimer from the blood specimen holder.
Regarding claim 8, modified Tu fails to teach the apparatus of claim 6, wherein the disposable cassette is contained in a package with a disposable dropper, the disposable dropper containing a volume of diluent buffer for mixing with the blood sample.
BIOSYNEX teaches single use cassettes for D-Dimer testing (page 1, left column, sections “Intended use” and “Precautions”). BIOSYNEX teaches materials provided includes the test devices that are pouched, droppers, and a vial with diluent, i.e. diluent buffer for mixing with the blood sample (page 1, right column, section “Materials”). BIOSYNEX teaches adding drops of whole blood and then adding a drop of dilution buffer (page 1, right column, section “Directions for use”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Tu to incorporate the teachings of materials for D-Dimer testing including single use test devices in pouches, droppers, and diluent for dropping into a sample well with blood (page 1, right column, sections “Materials”, “Directions for use”) to provide: the apparatus of claim 6, wherein the disposable cassette is contained in a package with a disposable dropper, the disposable dropper containing a volume of diluent buffer for mixing with the blood sample. Doing so would have a reasonable expectation of successfully improving sample processing of a sample with appropriate materials as taught by BIOSYNEX.
Claims 9-11, 13 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Nahm as applied to claim 1 above, and further in view of BIOSYNEX (BIOSYNEX D-dimer User Guide, Version 04 EN 03/20; cited in the IDS filed 12/23/2021).
Regarding claim 13, Tu further teaches the apparatus of claim 1, further comprising a display (Fig. 2, display 102) configured to display graphical and/or textual information ([0013],[0087]), wherein the processor is programmed to analyze data from an imager ([0013]) and to provide information to the display ([0013],[0087]).
Modified Tu fails to teach: the apparatus further comprising a second composition on a membrane spaced apart from the first composition, the second composition configured to provide a second indicator when mixed with blood, and wherein the processor is programmed to provide information to the display when it detects the second indicator which indicates that a proper blood sample was received.
BIOSYNEX teaches a D-dimer test using an immunochromatographic rapid test for detection of D-dimer in blood (page 1, left column, section “Intended Use”). BIOSYNEX teaches a blood specimen holder (page 1, left column, figure of the test device) comprises a sample well (page 1, left column, figure of the test device), a D-dimer testing zone (test line), and a membrane in fluid communication with the well and the D-dimer testing zone (membrane from the sample well to the test line), the membrane configured to fluidly communicate the blood sample to the D-dimer testing zone (page 1, left column, section “Principle”), wherein a composition on the membrane in the D-dimer testing zone is configured (page 1, left column, section “Principle”, teaches the test line region includes an color marked conjugate, i.e. anti-D-dimer antibody-gold conjugate), when mixed with blood containing a D-dimer protein, to provide an indicator (page 1, left column, section “Principle”, teaches the color marked anti-D-dimer provides a distinct color that indicates a positive result of D-dimer). BIOSYNEX teaches D-dimer concentration and testing may help in diagnosis of thrombosis (page 1, left column, section “Summary”). BIOSYNEX teaches a control line spaced from a test line (page 1, left column, figure of the device). BIOSYNEX teaches a control line that serves as a procedural indicator, i.e. second indicator, for the proper functioning of the device (page 1, left column, section “Principle”); wherein the control line appears red as an internal positive procedural control that confirms that sufficient specimen volume was used and indicates an adequate membrane wicking and proper procedural technique (page 2, left column, section “Quality control”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Tu to incorporate BIOSYNEX’s teachings of a control line that confirms that sufficient specimen volume was used and indicates an adequate membrane wicking and proper procedural technique (page 2, left column, section “Quality control”) to provide: the apparatus further comprising a second composition on a membrane spaced apart from the first composition, the second composition configured to provide a second indicator when mixed with blood, and wherein the processor is programmed to provide information to the display when it detects the second indicator which indicates that a proper blood sample was received. Doing so would have a reasonable expectation of successfully improving automated confirmation of sufficient specimen volume, adequate membrane wicking, and proper procedural technique.
Regarding claim 30, Tu further teaches the apparatus of claim 1, wherein the blood specimen holder comprises a well (Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto) configured to collect the blood sample (interpreted as a functional limitation, see MPEP 2114; Fig. 13F and [0180] teaches the test cartridge includes a test strip sample well where a sample is pipetted onto; [0113] and [0197] teaches blood samples; therefore, the sample well is structurally capable of collecting a blood sample).
Modified Tu fails to teach the blood specimen holder comprises a D-dimer testing zone, and a membrane in fluid communication with the well and the D-dimer testing zone, the membrane configured to fluidly communicate the blood sample to the D-dimer testing zone, wherein a composition on the membrane in the D-dimer testing zone is configured, when mixed with blood containing a D-dimer protein, to provide an indicator.
Tu teaches a need for testing samples for biomarkers indicative of medical conditions and automatically facilitate the parallel processing of multiple colorimetric-based or fluorescent-based lateral flow immunoassay test strips or chemistry-based test strips for automated testing at the point-of-care ([0011]). Tu teaches the system including a processor configured to execute instructions to analyze an image of a test strip to indicate one or more patient conditions ([0013]). Tu teaches the device may be configured to perform different types of tests ([0072]) and a plurality of test cartridges for different test types ([0184]). Tu teaches a plurality of types of test cartridges or test strips usable to test for a plurality of different patient conditions ([0322]). Tu teaches a test strip including pads for colorimetric analysis ([0086]). Tu teaches patient samples can include saliva and blood ([0153],[0170], [0197]).
BIOSYNEX teaches a D-dimer test using an immunochromatographic rapid test for detection of D-dimer in blood (page 1, left column, section “Intended Use”). BIOSYNEX teaches a blood specimen holder (page 1, left column, figure of the test device) comprises a sample well (page 1, left column, figure of the test device), a D-dimer testing zone (test line), and a membrane in fluid communication with the well and the D-dimer testing zone (membrane from the sample well to the test line), the membrane configured to fluidly communicate the blood sample to the D-dimer testing zone (page 1, left column, section “Principle”), wherein a composition on the membrane in the D-dimer testing zone is configured (page 1, left column, section “Principle”, teaches the test line region includes an color marked conjugate, i.e. anti-D-dimer antibody-gold conjugate), when mixed with blood containing a D-dimer protein, to provide an indicator (page 1, left column, section “Principle”, teaches the color marked anti-D-dimer provides a distinct color that indicates a positive result of D-dimer). BIOSYNEX teaches D-dimer concentration and testing may help in diagnosis of thrombosis (page 1, left column, section “Summary”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood specimen holder of modified Tu to incorporate Tu’s teachings testing biomarkers using multiple test strips ([001],[0013] ,[0322]), test strips including pads and a sample well ([0086]; [0180]) and imaging for colorimetric analysis ([0013],[0086]) and BIOSYNEX’s teachings of a D-dimer test cassette with a test strip with a test line, control line, membrane, and sample well (page 1, Left column, figure of the test device) to provide: the blood specimen holder comprises a D-dimer testing zone, and a membrane in fluid communication with the well and the D-dimer testing zone, the membrane configured to fluidly communicate the blood sample to the D-dimer testing zone, wherein a composition (i.e. anti-D-dimer antibody-gold conjugate) on the membrane in the D-dimer testing zone is configured, when mixed with blood containing a D-dimer protein, to provide an indicator (i.e. colored marking of the test line). Doing so would have a reasonable expectation of improving sensitivity and diagnostic of D-dimer from the blood specimen holder.
Regarding claim 9, modified Tu further teaches the apparatus of claim 30, wherein the composition is an anti-D-dimer antibody conjugate (see above claim 30; modified Tu in combination with BIOSYNEX provides a composition, i.e. anti-D-dimer antibody-gold conjugate; BIOSYNEX, page 1, left column, section “Principle”, teaches the test line region includes an color marked conjugate, i.e. anti-D-dimer antibody-gold conjugate).
Regarding claim 10, modified Tu further teaches the apparatus of claim 9, wherein the anti-D-dimer antibody is an anti-D-dimer-gold conjugate (see above claim 30; modified Tu in combination with BIOSYNEX provides a composition, i.e. anti-D-dimer antibody-gold conjugate; BIOSYNEX, page 1, left column, section “Principle”, teaches the test line region includes an color marked conjugate, i.e. anti-D-dimer antibody-gold conjugate).
Regarding claim 11, modified Tu further teaches the apparatus of claim 30, wherein the indicator is a colored marking on the membrane (see above claim 30; modified Tu in combination with BIOSYNEX provides the indicator as a colored marking on the test line; BIOSYNEX, page 1, left column, section “Principle”, teaches the color marked anti-D-dimer provides a distinct color that indicates a positive result of D-dimer).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Nahm as applied to claim 29 above, and further in view of Du et al. (Du et al., “The diagnostic value of pepsin detection in saliva for gastro-esophageal reflux disease: a preliminary study from China”, BMC Gastroenterology, 2017, 17:107).
Regarding claim 12, modified Tu fails to teach the apparatus of claim 29, wherein the threshold level of the pepsin is 76 ng/mL.
Tu teaches if the change in pixel intensity is stronger than a threshold on both sides of the test result line, the algorithm reports the detection of the test result line and a positive result ([0085]).
Du teaches pepsin in saliva has been proposed as a promising diagnostic biomarkers for gastro-esophageal reflux (abstract). Du teaches measuring pepsin concentration from saliva with the optimal cut-off value for diagnosing GERD was 76 ng/mL, which allows for a more powerful ability to identify GERD (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Tu to incorporate Tu’s teachings of detection based on a threshold ([0085]) and Du’s teachings of an optimal cut-off value of pepsin for diagnosing GERD of 76 ng/mL (abstract) to provide: the apparatus of claim 29, wherein the threshold level of the pepsin is 76 ng/mL. Doing so would have a reasonable expectation of successfully improving sensitivity for identification of pepsin for medical conditions such as GERD.
Response to Arguments
Applicant’s arguments, see page 1, filed 07/24/2026, with respect to the drawing objections have been fully considered and are persuasive. The drawing objections of 04/24/2026 have been withdrawn.
Applicant’s arguments, see page 1, filed 07/24/2026, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive, except for the rejection of claim 14 regarding “the D-dimer testing zone” which has been maintained. The rejections under 35 U.S.C. 112(b), except for the rejection of claim 14 regarding “the D-dimer testing zone”, of 04/24/2026 have been withdrawn.
Applicant's arguments, see pages 1-2, filed 07/24/2026, with respect to the rejections under 35 U.S.C. 101, have been fully considered but they are not persuasive.
In response to applicant’s arguments that all of the claim limitations of claim 1 was not considered, and the additional limitations of “a saliva specimen holder…” and “blood specimen holder…” are not abstract ideas, therefore the claims are not directed towards abstract ideas (Remarks, pages 1-2), the examiner disagrees.
In accordance with MPEP 2106, the claims are found to recite statutory subject matter (Step 1: YES) and are analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A: Prong 1).
In the instant application, within claim 1, the limitations of “determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample” could be performed mentally or by math. Other than “processor”, if the claim limitations, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components (e.g. processor), then the claim limitations fall within the “Mental Processes” grouping of abstract ideas (MPEP 2106.05(f)). Accordingly, the claims recite abstract ideas (Step 2A: Prong 1: Yes).
MPEP 2106.04(d) states accordingly, after determining that a claim recites a judicial exception in Step 2A Prong One, examiners should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception in Step 2A Prong Two.
In claim 1, after the limitation of “determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample”, no further action is performed. Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The processor limitations are recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Additionally, the additional limitations of claim 1, “a saliva specimen holder…” and “blood specimen holder…” generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)). Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claimed limitations are directed to an abstract idea that is not integrated into a practical application (Step 2A, Prong 2: No).
The claims 1-14 and 29-30 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding the abstract idea, claim 1 merely recites the processor, wherein the claimed limitations of the processor amount to no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Claim 1 and dependent claims 2-14 and 29-30 further recites limitations, however these limitations generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering or data outputting, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)), which alone or in combination do not amount to significantly more. Additionally, the limitations of claims 1-14 and 29-30 are well-understood, routine and conventional activities as evidenced by the prior art of: Tu et al. (US 20210285977 A1; effectively filed 06/23/2017), Nahm et al. (US 20050214951 A1), Lee et al. (LEE, Y. J., et al., "Optimization of Saliva Collection and Immunochromatographic Detection of Salivary Pepsin for Point-of-Care Testing of Laryngopharyngeal Reflux," Sensors, 2020, 20(1): 325; cited in the IDS filed 12/23/2021), BIOSYNEX (BIOSYNEX D-dimer User Guide, Version 04 EN 03/20; cited in the IDS filed 12/23/2021), and Du et al. (Du et al., “The diagnostic value of pepsin detection in saliva for gastro-esophageal reflux disease: a preliminary study from China”, BMC Gastroenterology, 2017, 17:107). See MPEP 2106.05(d). The additional elements of the claims 1-14 and 29-30 do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). The claims are not patent eligible.
Applicant's arguments, see pages 2-3, filed 07/24/2026, with respect to the rejections under 35 U.S.C. 103, have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references since Nahm fails to specifically teach a processor that is programmed specifically to determine whether pepsin is detected in a saliva sample and whether a D-dimer protein is detected in a blood sample, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Tu provides motivation of: a need for testing samples for biomarkers indicative of medical conditions and automatically facilitate the parallel processing of multiple colorimetric-based or fluorescent-based lateral flow immunoassay test strips or chemistry-based test strips for automated testing at the point-of-care ([0011]). Tu provides teachings and suggestions of a processor for analyzing samples: the system including a processor configured to execute instructions to analyze an image of a test strip to indicate one or more patient conditions ([0013]). Tu provides motivation of: the device may be configured to perform different types of tests ([0072]) and a plurality of test cartridges for different test types ([0184]); a plurality of types of test cartridges or test strips usable to test for a plurality of different patient conditions ([0322]). Tu provides teachings and motivation for analyzing saliva and blood: patient samples can include saliva and blood ([0153],[0170], [0197]).
Nahm provides teachings and motivation of: a lateral flow quantitative assay method which can measure one or more analyte species at the same time with high sensitivity, the method includes using a lateral flow assay strip (abstract). Nahm provides teachings and motivation of: various analytes to be analyzed in a liquid sample, such as blood and saliva ([0054]), includes D-dimer ([0066]) and pepsin ([0088]). Nahm teaches all of these proteins can be quantified by the package comprising the lateral flow assay strip ([0088]). Nahm provides motivation: it would be advantageous in terms of economic aspects and other aspects to provide a method capable of rapidly and precisely quantifying different kinds of analytes at the same time, to satisfy demands of both general consumers and those involved in medical fields for development of such products ([0010]). Nahm teaches a label which can act as an indicator of presence or absence of an analyte in a liquid sample ([0099]).
Thus, since Tu teachings a processor for analyzing saliva and blood and Nahm teaches analyzing blood and saliva samples for analytes including D-dimer and pepsin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Tu to incorporate Tu’s teachings of a need for testing samples for biomarkers indicative of medical conditions and automatically facilitating parallel processing and testing of test strips ([0011]), the processor analyzing test cartridges for multiple different patient conditions ([0013],[0072],[0184], [0322]), and samples includes saliva and blood ([0153],[0170],[0197]) and Nahm’s teachings of measuring multiple analyte species using lateral flow assays ([abstract; [0010],[0088]), analytes of blood and saliva can include D-dimer and pepsin ([0054],[0066],[0088]) and a label acting as an indicator for an analyte in the sample ([0099]) to provide: the processor programmed to determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample. Doing so would have a reasonable expectation of successfully improving throughput, automation, and efficiency of detecting and quantifying different kinds of desired analytes (i.e. D-dimer and pepsin), therefore allowing for improved analysis of different medical conditions of a patient.
Furthermore, since Tu teaches a need for testing blood and saliva samples for biomarkers indicative of medical conditions from multiple test strips and Nahm teaches a finite number of identified, predictable types of analytes to analyze, e.g. D-dimer and pepsin, and predictable types of liquid samples, e.g. blood and saliva, it would have been obvious to have modified the processor to choose detecting D-dimer in blood and pepsin in saliva from a finite number of identified, predictable analytes and liquid samples for analysis as discussed by Nahm ([0054],[0066],[0088],[0099]) to provide: the processor programmed to determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample. I.e., it would have been obvious to try the specific processor programmed to determine whether pepsin is detected in a collected saliva sample and determine whether a D-dimer protein is detected in a collected blood sample to improve analysis of different kinds of desired analytes (e.g. D-dimer protein and pepsin) in known kinds of liquid samples (e.g. blood and saliva) with a reasonable expectation of success. See MPEP 2143(I)(E).
Thus, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed processor limitations in view of Tu and Nahm’s teachings of known liquid samples (e.g. saliva and blood) and known analytes (e.g. D-dimer and pepsin).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kang et al. (US 20190011465 A1) teaches an immunoassay device for detecting one or more targets or markers such as D-Dimer (abstract). Kang teaches a device in the form of a cassette can have windows for sample application and signal detection ([0090]). Kang teaches a test strip including an indicator pad, nitrocellulose membrane, blood separation filter pad, and reservoir filter pad; and the test strip thus prepared was assembled into a plastic cassette housing in such a way that the sample application well is located right above the blood separation filter pad and the result reading window is right above the assay indicia zone enabling visual or reader reading of the results when the assay is performed ([0153]).
Rai et al. (US 20230314424 A1; effectively filed 08/17/2020) teaches testing devices for detecting the level of one or more analytes in a fluid including one or more lateral flow strips (abstract). Rai teaches if the testing device is configured to test for the presence of pepsin in saliva, the conjugate may include anti-pepsin antibodies coupled to colormetric labels; when saliva is flowed over the sample pad and then over the conjugate pad, the conjugates including the anti-pepsin antibodies may bind to any pepsin present in the saliva; and free, unbound conjugates as well as conjugates that have bound to an analyte of interest may flow with the fluid to the nitrocellulose membrane ([0030]).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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