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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments submitted on 10 April 2026. In view of the new grounds of rejection presented herein under 35 USC 112(b) not necessitated by Applicant’s amendments, this office action is NON-FINAL.
Status of the claims:
Claims 47 and 61-80 are pending.
Claims 1-46 and 48-60 are canceled.
No claims are withdrawn.
No claims are newly added.
Claims 47, 61-62, 64, 67, 71, 73, and 76-77 are amended.
Claim Objections
Claim 47 is objected to because of the following informalities: The claim recites “upon received in the port” and should be amended to recite “upon being received in the port”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“data analyzer adapted for wireless communication and having one or more processors configured to...apply region-specific signal correlation logic to the first optical signal data and the second optical signal data...determine a concentration of at least the first analyte and the second analyte present in the biological sample based on the applied region-specific signal correlation logic and a comparative analysis of the first optical signal data and the second optical signal data” as in Claim 47.
“a single use assay device adapted for reception” as in Claim 47.
“software adapted to” as in Claims 71-75 and 77-78.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
***No sufficient recitation as to the particular software/algorithm(s) used by the processor to achieve the function of “apply[ing] region-specific signal correlation logic” is present in Applicant’s disclosure.*** -- See the 35 USC 112b/2nd section below regarding computer-implemented software claims.
The test strip defined in para. [0004] of Applicant’s instant specification.
***No sufficient recitation as to the particular software/algorithm(s) is present in Applicant’s disclosure.*** -- See the 35 USC112b/2nd section below regarding computer-implemented software claims.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 47 and 61-80 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.
Claim 47 recites “a port for receiving an assay device...a single-use assay device adapted for reception in the port” wherein it is unclear if the assay device and the single-use assay device refer to the same device or separate devices which are both inserted into the port. The “a single-use assay device adapted for reception in the port” would normally be interpreted under 35 USC 112(f) as requiring a particular structure such as a test strip be disclosed; however, Applicant’s specification appears to indicate only a single test strip type, wherein the elements of the test strip are inferentially provided by the claim. If it is Applicant’s intent to claim both the test strip and the reader as a system/kit-type claim, Applicant is suggested to positively claim the single use assay device and provide it with all the structure recited earlier in the claim regarding the assay device. At present, the claim merely requires a reader having a port, not positively requiring any of the details of the assay device, and a single-use assay device seemingly intended for the reader but having no particular structure. Appropriate clarification is required.
Claim 47 further recites “software executable on a mobile device in wireless communication with the data analyzer”; however, the required software is not correlated to the active steps undertaken by the processor, and it is unclear what the software is configured for and how the software is structured within the operation of the device. Applicant may wish to merely strike this recitation from the claim, the processors being “configured to” accounting for the specially programmed functions.
Claim 72 recites “fertility-related outcomes”; however, the metes and bounds of “fertility-related” are unclear, and wherein Applicant’s specification does not particularly define the scope of that term.
Further, Claims 47, 71-75, and 77-78 are reliant on particular software for accomplishing the functionality of “apply[ing] region-specific signal correlation logic to the first optical signal data and the second optical signal data...determin[ing] a concentration of at least the first analyte and the second analyte present in the biological sample” However, the written description fails to disclose the algorithm(s) for performing the claimed specific computer functions of “applying” and “determining” as required by Claim 47, and as discussed by the software capabilities of Claims 71-75 and 77-78. -- See MPEP 2181(II)(B): For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). -- See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008).
See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) (“[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general-purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’”) (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)). In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general-purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function.
See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. For a computer-implemented means-plus-function claim limitation invoking 35 U.S.C. 112(f) the Federal Circuit has stated that “a microprocessor can serve as structure for a computer implemented function only where the claimed function is ‘coextensive’ with a microprocessor itself.”
See EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622, 114 USPQ2d 1711, 1714 (Fed. Cir. 2015), citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737, 1747 (Fed. Cir. 2011). “‘It is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed.’” EON Corp., 785 F.3d at 621, 114 USPQ2 at 1714, quoting Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365, 102 USPQ2d 1122, 1125 (Fed. Cir. 2012). “‘[S]pecial programming’ includes any functionality that is not ‘coextensive’ with a microprocessor or general-purpose computer.”
EON Corp., 785 F.3d at 623, 114 USPQ2d at 1715 (citations omitted). “Examples of such coextensive functions are ‘receiving’ data, ‘storing’ data, and ‘processing’ data—the only three functions on which the Katz court vacated the district court’s decision and remanded for the district court to determine whether disclosure of a microprocessor was sufficient.” 785 F.3d at 622, 114 USPQ2d at 1714. Thus, “[a] microprocessor or general-purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer implemented functions require disclosure of an algorithm.” Id., 114 USPQ2d at 1714.
To claim a means for performing a specific computer-implemented function and then to disclose only a general-purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999); Rain Computing, Inc. v. Samsung Electronics America Co., 989 F.3d 1002, 1007-8, 2021 USPQ2d 284 (Fed. Cir. 2021).
The corresponding structure is not simply a general-purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. Thus, the specification must sufficiently disclose an algorithm to transform a general-purpose microprocessor to the special purpose computer. See Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1241. (“Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy 35 U.S.C. §112 ¶ 6. It was required, however, to at least disclose the algorithm that transforms the general-purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.’” (quoting WMS Gaming, 184 F.3d at 1349, 51 USPQ2d at 1391.))
An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002. Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow char t, or “in any other manner that provides sufficient structure.”
Finisar, 523 F.3d at 1340, 86 USPQ2d at 1623; see also Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.
However, no specific algorithm(s) is/are defined and the functions therein Claim 47 go beyond a general-purpose computer and are not coextensive with the computer as defined in the MPEP passages cited above.
Therefore, the claim(s) is/are indefinite and rejected under 35 USC 112b/2nd. Applicant may provide a citation to the literature which introduces such software Applicant was in possession of coincident with the above discussion. Discussion with respect to the software/algorithms as in Claim 47 is not found within the disclosure.
Further, Applicant’s software must be provided as embodied on a non-transient machine-readable memory of the mobile device, the claim presently not even positively requiring the presence of the mobile device, but rather software as an independent element having no particular metes and bounds and is not structurally or functionally related to the data analyzer, the mobile device having the wireless communication capability not positively required by the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 47, 61-63, 65, 71, and 73-80 are rejected under 35 U.S.C. 103 as being unpatentable over Moynihan et al. (US 2014/0154792), hereinafter “Moynihan”, in view of Catt et al. (US 2007/0015285 A1), hereinafter “Catt”.
Regarding Claim 47, Moynihan teaches a diagnostic test system for quantitative detection of a first analyte and a second analyte in a biological sample (system for detecting the concentration of an analyte within a sample, see [0003] – Abstract: “analyzing one or more analytes in a fluid sample”), 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 illuminating at least a first region and a second region of the assay device upon received in the port (light source 302, see Fig. 3a, 15a, and [0058] – as Applicant’s recited regions are not particularly defined, the light source of Moynihan is said to commensurately cover relative regions.);
one or more optical detectors for detecting optical signals emitted from said the first region and the second region of the 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:
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]).
Further regarding Claim 47, Moynihan does not specifically teach the diagnostic test system discussed above wherein the processors are configured to receive first optical signal data corresponding to the first region of the assay device and second optical signal data corresponding to the second region of the assay device; apply region-specific signal correlation logic to the first optical signal data and the second optical signal data as detected by the one or more optical detectors, the region-specific signal correlation logic defining an inverse correlation between the first optical signal data and the first analyte, the inverse correlation corresponding to a competitive binding interaction at the first region of the assay device, and a direct correlation between the second optical signal data and the second analyte, the direct correlation corresponding to a binding interaction at the second region of the assay device; and determine a concentration of at least the first analyte and the second analyte present in the biological sample based on the applied region-specific signal correlation logic and a comparative analysis of the first optical signal data and the second optical signal data, as in Claim 47.
However, Catt teaches a respective lateral flow test strip and optical reader therefor ([0103]: “The assay device/reader combination can be supplied to the consumer as a single test kit. In general however, whereas the reader will be a relatively permanent unit which the consumer can use time and again (and which may be provided with an electronic memory/data-processing facility which enables the results of many sequential assays to be evaluated) the testing devices will be intended for use only once and thereafter will be discarded.”) for detecting two analytes at separate strip regions using a light source and optical detectors ([0139-0141]: discussion regarding two separate detection zones for E3G and LH analytes – see [0109-0111, 0118] and Fig. 9 regarding the light source and detector reading the strip regions (detection zones 610 and 611).), further comprising a processor configured to receive first optical signal data corresponding to the first region of the assay device and second optical signal data corresponding to the second region of the assay device ([0018]: “electronic processing means to interpret said test signals” – see [0139-0141] discussing detection at the different detection zones.); apply region-specific signal correlation logic to the first optical signal data and the second optical signal data as detected by the one or more optical detectors, the region-specific signal correlation logic defining an inverse correlation between the first optical signal data and the first analyte, the inverse correlation corresponding to a competitive binding interaction at the first region of the assay device ([0139]: “The E3G related signal is the result of a “competition” reaction and accordingly the E3G related signal diminishes in intensity with increasing E3G concentration.”), and a direct correlation between the second optical signal data and the second analyte, the direct correlation corresponding to a binding interaction at the second region of the assay device ([0139]: “The LH related signal is generated by means of a “sandwich” reaction and its intensity increases with increasing LH concentration.”); and determine a concentration of at least the first analyte and the second analyte present in the biological sample based on the applied region-specific signal correlation logic and a comparative analysis of the first optical signal data and the second optical signal data ([0140]: “If desired the signals generated by the device can be standardised against known concentrations of E3G and LH.”). Therein, this arrangement of Catt provides for more reliable identification by measuring more than one analyte, reducing false results ([0007-0009]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the diagnostic test system of Moynihan wherein the processors are configured to receive first optical signal data corresponding to the first region of the assay device and second optical signal data corresponding to the second region of the assay device; apply region-specific signal correlation logic to the first optical signal data and the second optical signal data as detected by the one or more optical detectors, the region-specific signal correlation logic defining an inverse correlation between the first optical signal data and the first analyte, the inverse correlation corresponding to a competitive binding interaction at the first region of the assay device, and a direct correlation between the second optical signal data and the second analyte, the direct correlation corresponding to a binding interaction at the second region of the assay device; and determine a concentration of at least the first analyte and the second analyte present in the biological sample based on the applied region-specific signal correlation logic and a comparative analysis of the first optical signal data and the second optical signal data, such as suggested by Catt, so as to reduce the occurrence of false results by measuring two analytes rather than one.
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]).
Claims 64 and 66-70 are rejected under 35 U.S.C. 103 as being unpatentable over Moynihan in view of Catt as applied to 47, 61-63, 65, 71, and 73-80 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 in view of Catt as applied to 47, 61-63, 65, 71, and 73-80 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.
Response to Arguments
35 USC 102
Regarding Claim 47, Applicant’s arguments are on the alleged grounds that Moynihan does not teach or suggest the claim amendments requiring analysis of two analytes at two regions of the chip and using correlation logic and comparative analysis to determine their concentrations.
Applicant’s argument is persuasive; however, the requirements of Applicant’s amendment are accounted for by Catt teaching a respective test strip testing for two analytes at the same time so as to improve the accuracy of the analysis, rather than relying on just a single analyte to determine an analysis result, Catt disclosing the same inverse and direct correlational analysis of analytes in a single test strip having separate regions for testing the different analytes. – See above in the body of the action.
Thus, Examiner sets forth the rejection of Claims 47 and 61-80 as being unpatentable under 35 USC 103 over at least the prior art of Moynihan in view of Catt, the newly added prior art of Catt and new grounds of rejection thereof being necessitated by Applicant’s amendment. Given this, Applicant’s assertion that Claims 61-80 are allowable by virtue of dependency on Claim 47 is moot as Claim 47 is rejected under 35 USC 103 herein.
Regarding Claims 64, 66-70, and 72, Applicant’s arguments are on the alleged grounds that the additional prior art references of Nazareth and McCarthy fail to cure the above discussed alleged deficiencies of Moynihan. However, as discussed above, those alleged deficiencies of Moynihan are cured by Catt. Nazareth and McCarthy are not relied on for curing the disputed and discussed deficiencies on Moynihan, thus Applicant’s argument is moot.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
