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 .
Election/Restrictions
Applicant’s election without traverse of Claims 47 and 61-80 in the reply filed on 10/27/2025 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 47, 61-63, 65, 71, and 73-80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moynihan et al. (US 2014/0154792, “Moynihan”).
Regarding claim 47, Moynihan teaches a diagnostic test system for quantitative detection of one or more analytes in a biological sample (system for detecting the concentration of an analyte within a sample, see [0003]), comprising:
a hand-held analyzer device (portable reader, see Fig. 2a and [0075]) , comprising:
a port for receiving an assay device (port 201 for accepting cartridge 107, see Fig. 1 and [0145]);
one or more light sources for illuminating one or more regions of an assay device upon received in the port (light source 302, see Fig. 3a, 15a, and [0058]);
one or more optical detectors for detecting optical signals emitted from said the one or more illuminated regions of an assay device received in the port (photosensor 306, see Fig. 3a and 15a, [0062], and [0157]); and
A data analyzer adapted for wireless communication and having one or more processors (reader system that incorporates processors 104a, 104b and wireless communication 114, see Fig. 1 and [0146]) configured to:
determine, based on test-specific information obtained from an assay device received in the port and the optical signals detected by the one or more optical detectors, a concentration of one or more analytes present in a biological sample at an assay device received in the port (the reader system is configured to read an RFID chip on cartridge to obtain cartridge identification information and information regarding analyte concentration after optical reading, see [0056] and [0122]);
a single-use assay device adapted for reception in the port of the hand-held analyzer device (immunoassay device within cartridge 107, see Fig. 3a and [0096]);
And software executable on a mobile device in wireless communication with the data analyzer (software on mobile device that allows communication with reader, see [0072] and [0095]).
Regarding claim 61, Moynihan teaches the diagnostic test system according to claim 47, wherein the one or more light sources are fluorescent light sources (light sources are LEDs which are fluorescent light sources, see [0008] and [0074] in Instant Specification) ; and
the one or more optical detectors detect optical signals in the form of emitted fluorescent signals (photosensors are used to detect fluorescence, see [0144]).
Regarding claim 62, Moynihan teaches the diagnostic test system according to claim 61, wherein the fluorescent light sources are adapted for outputting fluorescent light within a predetermined wavelength and the optical detectors are adapted for detecting emitted fluorescent signals within the predetermined wavelength, the predetermined wavelength being between about 300 nm and about 900 nm (the light source outputs a wavelength of 606nm where the detector senses a wavelength of 665nm or 590nm, see [0153] - [0156]).
Regarding claim 63, Moynihan teaches the diagnostic test system according to claim 47, wherein the diagnostic test system is adapted for self-administration in a non-laboratory setting (the hand-held system is portable and used in poiny-of-care settings and is therefore adapted for non-laboratory settings, see [0002] and [0075]).
Regarding claim 65, Moynihan teaches the diagnostic test system according to claim 61, wherein the assay device is adapted to generate the emitted fluorescent signals through a competitive assay, a sandwich assay, or a combination of both (the assay device uses a competitive assay, see [0107] and [0048] in Moynihan).
Regarding claim 71, Moynihan teaches the diagnostic test system according to claim 47, wherein the software executable on a mobile device is configured to receive instructions from the data analyzer of the hand-held analyzer device for displaying determination results of the one or more processors of the hand-held analyzer device on a graphical user interface of said mobile device (software on mobile device that allows communication with reader, see [0072] and [0095], where the wirelessly connected device is sent the results of the assay for display by a printer or other display, see [0146] and [0159] - [0161]).
Regarding claim 73, Moynihan teaches the diagnostic test system according to claim 71, wherein the software executable on said mobile device is adapted to calculate and compare differences between intensity values calculated from optical signals detected from the capture region and optical signals detected from the control region to determine a positive or negative test result (the algorithm which is a software update from the mobile device is used to compare intensity values from a capture region to a control region to determine a positive or negative test, see [0025] and [0105] - [0111]).
Regarding claim 74, Moynihan teaches the diagnostic test system according to claim 71, wherein the software executable on said mobile device is adapted to interpret analyte trends using one or more of: baseline values, previous peak values, and rate-of-change data (the software used and uploaded to the reader includes previous peak values for comparison, see [0105].
Regarding claim 75, Moynihan teaches the diagnostic test system according to claim 71, wherein the software executable on said mobile device is adapted to instruct said mobile device to transmit test results to a remote storage device (the software relays instructions regarding remote diagnostics to a hospital information management system, see [0073]).
Regarding claim 76, Moynihan teaches the diagnostic test system according to claim 71, wherein the remote storage device is a cloud server, a health record server, or a healthcare provider storage device (see [0073]).
Regarding claim 77, Moynihan teaches the diagnostic test system according to claim 71, wherein the software executable on said mobile device is adapted to display fertility scores, ovulation day predictions, diagnostic summaries derived from analyte data, or a combination of the foregoing on a graphical user interface of said mobile device (diagnostic information based on readings are relayed to remote device, which is portable device, see [0161] and [0072] - [0073]).
Regarding claim 78, Moynihan teaches the diagnostic test system according to claim 71, wherein the data analyzer is adapted for wireless communication with said mobile device loaded with the software executable on said mobile device (the reader is adapted for wireless communication with a personal device, see [0072]-[0073] and [0095]).
Regarding claim 79, Moynihan teaches the diagnostic test system according to claim 78, wherein the data analyzer is adapted for indirect wireless communication with said mobile device over one or more intermediary devices, networks, or combinations of devices and networks (the reader connects to a mobile device via Wi-Fi, see [0072]-[0073], [0095], [0161]).
Regarding claim 80, Moynihan teaches the diagnostic test system according to claim 78, wherein the data analyzer is adapted for direct wireless communication with said mobile device over a wireless communication channel (the communication occurs over Wi-Fi which is a wireless communication channel, see [0161]).
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 64 and 66-70 are rejected under 35 U.S.C. 103 as being unpatentable over Moynihan et al. (US 2014/0154792, “Moynihan”) as applied to claim 47 above, and further in view of Nazareth et al. (US 2011/0201122, “Nazareth”, cited on 9/30/2022 IDS).
Regarding claim 64, Moynihan teaches the diagnostic test system according to claim 47, wherein the assay device (immunoassay) comprises a capture and control zone (see [0086) in addition to a chip readable by the hand-held analyzer device, the chip containing data comprising test- specific information (RFID containing information regarding test identification information, see [0056] and [0122]), but does not explicitly teach that the system comprises a test strip comprising a sample region, a labeling region, a capture region, and a control region; a mobilizable detection reagent at the labeling region adapted for specific binding to one or more analytes; an immobilized capture reagent at the capture region adapted to generate measurable optical signals, and an immobilized capture reagent at the control region adapted to generate measurable optical signals.
However, in the analogous art of immunoassays for use in lateral flow readers, Nazareth et al. teaches a device (see Abstract) further comprising a test strip comprising a sample region (portion of absorbent material 12, see Fig. 5 and [0110]), a labeling region (30), a capture region (34), and a control region (36, see Fig. 6 and [0112] - [0113]);
a mobilizable detection reagent at the labeling region adapted for specific binding to one or more analytes (two different mobilizable detection reagents located at bands 26 and 28, see Fig. [0112]);
an immobilized capture reagent at the capture region adapted to generate measurable optical signals (immobilized capture reagent 34 for generating a visible response, see [0107], [0113] and [0159]);
an immobilized capture reagent at the control region adapted to generate measurable optical signals (immobilized control reagent 36, see [0107] and [0113]).
While the invention of Moynihan et al. does not teach the specifics of the immunoassay used within the device, the reference does teach that the immunoassay comprises a capture and control area. Therefore, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify Moynihan et al. by including the essential immunoassay elements comprising a sample pad, labelling area, and capture and reagent zone as taught by Nazareth et al. for the benefit of detecting a plurality of analytes using a competitive immunoassay, see [0112] in Nazareth. Further, the modification of the immunoassay of Moynihan to incorporate the elements of Nazareth would not have deviated from the scope of the invention as both inventions are drawn to fluorescence-based immunoassays. Therefore, the modification of the immunoassay of Moynihan to include the sample, label, and capture, and control areas of Nazareth would have resulted in the implementation of a competitive immunoassay for qualitative or quantitative testing.
Regarding claim 66, modified Moynihan teaches the diagnostic test system according to claim 64, wherein the one or more processors are configured to determine the concentration of the one or more analytes by determining an intensity difference between optical signals detected from the capture region of the assay device upon reception in the port and optical signals detected from the control region of the assay device upon reception in the port (the reader's processors are used to compare intensity values from a capture region to a control region to determine a positive or negative test, see [0106] - [0111] in Moynihan).
Regarding claim 67, modified Moynihan teaches the diagnostic test system according to claim 64, wherein the assay device comprises two distinct mobilizable detection reagents at the labeling region (labeled binding member 26 and second binding partner 28, see [0112]), the first mobilizable detection reagent having a first fluorescent label and being adapted for specific binding to a first analyte (first binding partner is labeled with sol and binds to first epitope, see [0112]), the second mobilizable detection reagent having a second fluorescent label and being adapted for specific binding to a second analyte (second binding partner is labeled using biotin and binds to second epitope, see [0112] in Nazareth), the second fluorescent label being different from the first fluorescent label, and the second analyte being different from the first analyte (see [0112] in Nazareth).
Regarding claim 68, modified Moynihan teaches the diagnostic test system according to claim 64, wherein the mobilizable detection reagent at the labeling region is adapted for specific binding to human chorionic gonadotropin (hCG) (the analyte tested is hCG, see Abstract of Nazareth).
Regarding claim 69, modified Moynihan teaches the diagnostic test system according to claim 64, wherein the immobilized capture reagent at the control region comprises antibodies adapted for specific binding to excess detection reagent (immbolized control antibody captures excess reagent, see [0113] in Nazareth).
Regarding claim 70, modified Moynihan teaches the diagnostic test system according to claim 64, wherein the chip of the assay device contains defined operations for performance by the one or more processors of the hand-held analyzer device for determining the concentration of the one or more analytes (see [0056] in Moynihan).
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Moynihan et al. (US 2014/0154792, “Moynihan”) as applied to claim 71 above, and further in view of McCarthy et al. (US 2015/0094227, “McCarthy”).
Regarding claim 72, Moynihan teaches the diagnostic test system according to claim 71, wherein the software executable on said mobile device is adapted to display fertility-related outcomes based on analyte concentrations determined by the one or more processors of the hand-held analyzer device (remote diagnostics based on the reader's measured concentration are displayed on a separate wireless device, see [0111], [0133], and [0159] - [0161]).
However, the invention does not teach that the mobile device is adapted to display fertility-related outcomes based on analyte concentrations.
In the analogous art of portable readers for immunoassays that are wirelessly coupled to a user's personal device, McCarthy et al. teaches a device where a competitive assay (analogous to the immunoassay of Moynihan) is inserted into a portable reader for optical analysis and a result regarding pregnancy is displayed on the wireless device, see [0085] - [0086].
The device of Moynihan is used to determine the presence of a target analyte, including a protein (see [0049]) on a wireless device, where the device of McCarthy et al. uses the presence of a target protein to determine a fertility-related outcome on a wireless device. Therefore, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify Moynihan by incorporating a pregnancy reading on the wireless device as taught by McCarthy et al. for the benefit of quickly relaying a result of an assay to a user for interpretation and results storage, see [0085] in McCarthy. Further, the modification of the wireless device of Moynihan to incorporate the results interpretation of McCarthy et al. would have yielded the expected result of relaying fertility-related information to a user as both devices are used to relay health information to their respective users.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758