DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-20 are pending and examined herein.
Claims 1-20 are rejected.
Priority
Claims 1-20 are granted the claim to the benefit of priority to U.S. application 15/786139 filed 17 October 2017 (which the instant application is a continuation of) which is a continuation of 15/295353 filed 17 October 2016 and claims the benefit of priority to U.S. Provisional application 62/409077 filed 17 October 2016. Thus, the effective filling date of claims 1-20 is 17 October 2016.
Information Disclosure Statement
The information disclosure statements (IDS) were received on 02 October 2023 and 18 November 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Drawings
The drawings received 31 January 2023 are accepted.
Claim Rejections - 35 USC § 112
112/b
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 3,4, 10, 13, 14, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3 and 13 recite “wherein the control line serves as a control” and claims 4 and 14 recite “wherein the control is a dataset from previously conducted tests stored on a database and accessed by a software application” which renders the metes and bounds of these claims indefinite. The indefiniteness arises because it is unclear if this is meant to be an intended use of the control line (e.g., the control line is used as a control) or if this limitation is meant to mean using the control line as a control. If the limitation in claims 3 and 13 are meant to mean using the control line as a control, it is further unclear what is meant by “the control is a dataset from previously conducted tests stored on a database and accessed by a software application” in (claims 4 and 14) due to the control being a control line on the testing device. For the sake of furthering examination, claim 3 will be interpreted as “using the control line as a control” and claim 13 will be interpreted as “the server is further configured to use data from the control line as a control”.
Claims 4 and 14 recite “wherein the control is a dataset from previously conducted tests stored on a database and accessed by a software application” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear what part of the method or system this limitation is meant to limit because the limitation of “a control” is recited in claims 3 and 13 when providing that the control line is used as a control and the limitation of “a control line” is recited in claims 2 and 12 when providing the testing device includes a control line of a membrane strip of the testing device. Thus, it is unclear what part of the method or system is limited by the control being a dataset as recited in claims 4 and 14. For the sake of furthering examination, this limitation will be interpreted as further comprising obtaining control information.
Claims 10 and 20 recite “the test line of another one of the plurality of immunoassay test strips…” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear which test line is being referred to on another of the plurality of immunoassay test strips (since each test strip may have multiple test lines). For the sake of furthering examination this limitation will be interpreted as being “a test line of another one of the plurality of immunoassay test strips…”.
112/a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 4 and 14 recite “The method of Claim 3, wherein the control is a dataset from previously conducted tests stored on a database and accessed by a software application”. There is not an adequate written description for “using the control line as a control” (claim 3) and “the server is further configured to use data from the control line as a control” (claim 13) in combination with “wherein the control is a dataset from previously conducted tests stored on a database and accessed by a software application” (claims 4 and 14). The instant disclosure provides “the test line may not be compared with the control line to determine a result. Rather, the mobile device application may have access to a database having data on numerous past tests… This data may instead be used as a control” and there is no mention in the disclosure that the control line serves as a control and the control is a dataset at the same time” (instant disclosure [0078]) which shows that this data is used instead of the control line. There is not an adequate written description of using the control line (or control line data) and the control is a dataset from previously conducted tests stored on a database and accessed by a software application in combination.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
(Step 1)
Claims 1-10 fall under statutory category of a process and claims 11-20 fall under the statutory category of a machine.
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mental process”, such as procedures for evaluating, analyzing or organizing information, and forming judgement or an opinion. The instant claims further recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships and mathematical equations.
Independent claims 1 and 11 recite mental processes of “assigning correlative values as test results, wherein each test performed on the biological sample is assigned a different correlative value” and “assigning a unique identification to the biological sample”.
Independent claims 1 and 11 recite a mathematical concept of “assigning correlative values as test results, wherein each test performed on the biological sample is assigned a different correlative value”.
The claims recite mental processes of analyzing/evaluating data and making judgments as assigning correlative values as test results and assigning a unique identification to the biological sample. The human mind is capable of assigning values as test results and assigning a unique identification to a biological sample. The claims recite a mathematical concept as assigning correlative values as test results, wherein each test performed on the biological sample is assigned a different correlative value (which encompass calculating a quantitative value as the test result such as a reaction rating see dependent claims 6 and 7 and instant disclosure [0009] and [0010]). Dependent claims 4-7 and 14-17 further limit the mental process/mathematical concept recited in the independent claim but do not change their nature as a mental process/mathematical concept.
(Step 2A Prong 2)
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional element in claim 1 of collecting at least one biological sample by a testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biological sample contacts a sample on at least one of the plurality of immunoassay test strips and the additional element in claim 11 of a testing device configured to collect at least one biologic sample, the testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biologic sample contacts a sample pad on at least one of the plurality of immunoassay test strips, the additional element in claims 2 and 12 of further comprising binding antigens or antibodies of an immune complex to antigens or antibodies included on a control line of a membrane strip and wherein the testing device is further configured to bind antigens or antibodies of an immune complex to antigens or antibodies included on a control line of a membrane strip of the testing device, the additional element in claims 3 and 13 of wherein the control line is used as a control, the additional element in claims 8 and 18 of wherein a test line of at least one of the plurality of immunoassay test strips includes an antibody suitable for binding with hCG, the additional element in claim 9 and 19 of wherein a test line of at least one of the plurality of immunoassay test strips includes Zika virus antigen, and the additional elements in claims 10 and 20 of wherein a test line of one of the plurality of immunoassay test strips includes Zika virus antigen and the test line of another one of the plurality of immunoassay test strips includes and antibody suitable for binding with hCG do not integrate the judicial exceptions into a practical application because these additional elements are insignificant extra solution activity of data gathering (see MPEP 2106.05(g)). These additional elements constitute as data gathering because they only interact with the judicial exceptions in a manner by providing data to be processed by the judicial exceptions.
The additional elements in claims 1 and 11 of a server (interpreted as a generic computer) does not integrate the judicial exceptions into a practical application because this is simply applying the judicial exceptions to a generic computer without an improvement to computer technology (see MPEP 2106.04(d)(1)). The generic computer only interacts with the judicial exceptions by being utilized as a tool to perform the judicial exceptions.
The additional elements in claims 1 and 11 of receiving the test results at a server disposed on a network, wherein the server has configured thereon a database, storing the unique identification in the database, storing the test results in the database in association with the unique identification of the biologic sample does not integrate the judicial exceptions into a practical application, and providing access to the database to healthcare organizations for analysis of the test results (which encompasses displaying the database to a healthcare provider) because this is insignificant extra solution activity of data gathering and data outputting (see MPEP 2106.05(g)). These limitations constitute as data gathering and data outputting because they only interact with the judicial exceptions in a manner by providing data to be processed by the judicial exceptions and storing the output of the judicial exceptions.
The additional element in claims 1 and 11 of providing access to the database to healthcare organizations for analysis of the test results do not integrate the judicial exceptions into a practical application because this additional element constitutes as mere instructions to apply the exception (see MPEP 2106.05(f)). This additional element constitutes as mere instructions to apply the exception because this limitation only recites the idea of an outcome without how the outcome is accomplished and covers any solution for providing access to the database to healthcare organizations for analysis of the test results.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1-20 are directed to the abstract idea.
(Step 2B)
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The additional element in claim 1 of collecting at least one biological sample by a testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biological sample contacts a sample on at least one of the plurality of immunoassay test strips and the additional element in claim 11 of a testing device configured to collect at least one biologic sample, the testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biologic sample contacts a sample pad on at least one of the plurality of immunoassay test strips, the additional element in claims 2 and 12 of further comprising binding antigens or antibodies of an immune complex to antigens or antibodies included on a control line of a membrane strip and wherein the testing device is further configured to bind antigens or antibodies of an immune complex to antigens or antibodies included on a control line of a membrane strip of the testing device, the additional element in claims 3 and 13 of wherein the control line is used as a control, the additional element in claims 8 and 18 of wherein a test line of at least one of the plurality of immunoassay test strips includes an antibody suitable for binding with hCG, the additional element in claim 9 and 19 of wherein a test line of at least one of the plurality of immunoassay test strips includes Zika virus antigen, and the additional elements in claims 10 and 20 of wherein a test line of one of the plurality of immunoassay test strips includes Zika virus antigen and the test line of another one of the plurality of immunoassay test strips includes and antibody suitable for binding with hCG is conventional as shown by Wang et al. (Nano Biomed. Eng 8.3 (2016): 172-183) which reviews point of care testing which includes lateral flow immunoassays, shows a testing device with a plurality of testing strips (Wang et al. page 180 Fig. 10 and page 181 Fig. 13), test strips with a sample pad for collecting a biological sample (Wang et al. page 181 Fig. 15), shows this analysis is used for human chorionic gonadotropin hCG (page 173 right col. and page 174 left col.), shows this analysis is used for the detection of pathogens (page 173 right col. – page 174 left col.), test strips with control lines which are used as controls (Wang et al. page 181 Fig. 15), Meyers et al. (US 9,390,237 B2; cited in the IDS received 02 October 2023) which shows one or more optical registration marks on the test device for allowing the position and/or orientation of the test device to be determined by the reading device (Meyers et al. col. 4 lines 8-14), Roda et al. (TrAC Trends in Analytical Chemistry 79 (2016): 317-325) which reviews testing devices and shows an alignment target for the imaging of a test strip (Roda et al. page 319 Fig. 1 Panel 3), and López-Marzo et al. (Lab on a Chip 16.17 (2016): 3150-3176) which reviews assays including lateral flow assays and shows a developed lateral flow IgG/IgM test for Zika virus (page 3168 Fig. 8).
The additional elements in claims 1 and 11 of receiving the test results at a server disposed on a network, wherein the server has configured thereon a database, storing the unique identification in the database, storing the test results in the database in association with the unique identification of the biologic sample and the additional element in claims 1 and 11 of a server (interpreted as a generic computer) see MPEP 2106.05(b) and MPEP 2106.05(d)(II).
The additional element in claims 1 and 11 of providing access to the database to healthcare organizations for analysis of the test results which is conventional as shown by Xu et al. (Proceedings of the IEEE 103.2 (2015): 236-247) which reviews point-of-care diagnostics and shows providing access of point of care data such as immunoassay test strips to a health care provider (Xu et al. page 243 Fig. 6).
Thus, the additional elements are not sufficient to amount to significantly more than the judicial exception because they are conventional.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Aminoff et al. (US 20160274104 A1; cited in IDS received 02 October 2023) in view of Meyers et al. (US 9,390,237 B2; cited in IDS received 02 October 2023) in view of Beerling et al. (US 20170270249 A1; effective filling date of 15 March 2016).
Claim 1 is directed to a method for collection and dissemination of biologic data, comprising: collecting at least one biologic sample by a testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biologic sample contacts a sample pad on at least one of the plurality of immunoassay test strips;
Aminoff et al. shows contacting a sample obtained from a subject with a test for determining a biomarker or biomarkers (Aminoff et al. [0009]). Aminoff et al. shows that the test includes a lateral flow assay and shows that these assays include a sample pad in which the biological sample contacts (Aminoff et al. [0027], [0042], and Fig. 1).
assigning correlative values as test results, wherein each test performed on the biologic sample is assigned a different correlative value,
Aminoff et al. shows assigning correlative values as test results as outputting results indicating the presence, absence, or concentration of the biomarker in the sample (Aminoff et al. [0012] and [0076]).
receiving the test results at a server disposed on a network, wherein the server has configured thereon a database
Aminoff et al. shows a server in connection with the analyzer tool which receives information from the analyzer tool and the server receives the results from the test (Aminoff et al. [0058]-[0062]).
Aminoff et al. does not show the testing device including an alignment target, a testing device with multiple test strips, or wherein each test performed on the biologic sample is assigned a different correlative value.
Like Aminoff et al., Meyers et al. shows utilizing a testing device which includes a test strip, imaging the testing device to determine test results and transmitting information derived from the test to a server. Meyers et al. shows a test device which includes one or more optical registration marks for allowing the position and/or orientation of the test device to be determined by the reading device (Meyers et al. col. 4 lines 8-14). Meyers et al. shows the testing device having a plurality of test strips (Meyers et al. Fig. 1). Meyers et al. shows an image may include a plurality of responsive areas which are separately analyzed (Meyers et al. col. 7 lines 25-27).
Aminoff et al. in view of Meyers et al. does not show assigning a unique identification to the biologic sample, storing the unique identification in the database, storing the test results in the database in association with the unique identification of the biologic sample, and providing access to the database to healthcare organizations for analysis of the test results.
Like Aminoff et al. in view of Meyers et al., Beerling et al. shows the transfer and storing of medical testing results with a server and network. Beerling et al. shows assigning information as a test result summary which includes a sample identifier (ID) associated with the test and that test results are stored in a healthcare provider electronic health record server which is accessible by a healthcare organization and provider (Beerling et al. [0022], [0023], and [0029]).
Claim 11 recites a system for collection and dissemination of biologic data, comprising: a testing device configured to collect at least one biologic sample, the testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biologic sample contacts a sample pad on at least one of the plurality of immunoassay test strips;
Aminoff et al. shows a testing device configured to receive a sample obtained from a subject with a test for determining a biomarker or biomarkers (Aminoff et al. [0009]). Aminoff et al. shows that the test includes a lateral flow assay and shows that these assays include a sample pad in which the biological sample contacts (Aminoff et al. [0027], [0042], and Fig. 1).
a server remote from the testing device and disposed on a network, the server configured to: assign correlative values as test results, wherein each test performed on the biologic sample is assigned a different correlative value;
Aminoff et al. shows a server in connection with the analyzer tool which receives information from the analyzer tool and the server processes the information from the analyzer tool to output results from the test such as detecting the presence, absence, or concentrations of biomarkers (Aminoff et al. [0012], [0058] - [0062], and [0076]).
receive the test results, wherein the server has configured thereon a database;
Aminoff et al. shows a server which receives the test results and storing the test results (Aminoff et al. [0060]).
Aminoff et al. does not show the testing device including an alignment target, a testing device with multiple test strips, or wherein each test performed on the biologic sample is assigned a different correlative value.
Like Aminoff et al., Meyers et al. shows a testing device which includes a test strip, imaging the testing device to determine test results and transmitting information derived from the test to a server. Meyers et al. shows a test device which includes one or more optical registration marks for allowing the position and/or orientation of the test device to be determined by the reading device (Meyers et al. col. 4 lines 8-14). Meyers et al. shows the testing device having a plurality of test strips (Meyers et al. Fig. 1). Meyers et al. shows an image may include a plurality of responsive areas which are separately analyzed (Meyers et al. col. 7 lines 25-27).
Aminoff et al. in view of Meyers et al. does not show assigning a unique identification to the biologic sample, storing the unique identification in a database associated with the server, storing in the database the test results in association with the unique identification of the biologic sample, and providing access to the database to healthcare organizations for analysis of the test results.
Like Aminoff et al. in view of Meyers et al., Beerling et al. shows the transfer and storing of medical testing results with a server and network. Beerling et al. shows the transfer and storing of medical testing results with a server and network. Beerling et al. shows assigning information as a test result summary which includes a sample identifier (ID) associated with the test and that test results are stored in a healthcare provider electronic health record server which is accessible by a healthcare organization and provider (Beerling et al. [0022], [0023], and [0029]).
Claims 2 and 12 are directed to further comprising binding antigens or antibodies of an immune complex to antigens or antibodies included on a control line of a membrane strip and wherein the testing device is further configured to bind antigens or antibodies of an immune complex to antigens or antibodies included on a control line of a membrane strip of the testing device. Claims 3 and 13 are directed to using the control line as a control and the server is further configured to use data from the control line as a control. Claims 4 and 14 are directed to obtaining control information.
Aminoff et al. shows a testing device which binds antibodies of an immune complex to antibodies included on a control line of a membrane strip (Aminoff et al. Fig. 1). Aminoff et al. shows that the control line serves as a control for determining the validity of the test (Aminoff et al. Fig. 1). Aminoff et al. shows obtaining control information (Aminoff et al. [0118]).
Claims 5 and 15 are directed to wherein the test results include a qualitative result.
Aminoff et al. does not show wherein the test results include a qualitative result.
Meyers et al. shows that the output of the test includes a textual output (Meyers et al. col. 7 lines 44-46).
Claims 6 and 16 are directed to wherein the test results include a quantitative result. Claim 7 is directed to wherein the quantitative result is a reaction rating.
Aminoff et al. shows the test results include a reaction level and mean reaction level is provided (Aminoff et al. [0076] and [0094]).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to modify reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified the testing device of Aminoff et al. to include optical registration marks and multiple testing strips of Meyers et al. because this would allow the position and/or orientation of the test device to be determined by the reading device when utilizing a reader which is not attached to the testing device such as a mobile phone (Meyers et al. col. 4 lines 8-14) along with the ability to test for multiple biomarkers utilizing one testing device (Meyers et al. Fig. 1). It would have been further obvious to one of ordinary skill in the art before the effective filling date to have modified the storage of the data of Aminoff et al. in view of Meyers et al. to be in an electronic health record database accessible by a health provider and include information of a sample identifier (ID) associated with the test and test results of Beerling et al. because this would allow for a database which healthcare providers have access to the test results associated with a patient (Beerling et al. [0022] and [0023]) which healthcare providers may use in facilitating care of the patient and allow for additional information as a sample identifier associated with a test to provide further identification information along with the test results (Beerling et al. [0029]). One would have a reasonable expectation of success because Aminoff et al. shows a testing device with test strips for the detection of a biomarker and the transmission of data to a server while Meyers et al. shows a testing device with test strips which incorporates marks on the testing device to aid in position and/or orientation along and multiple test strips for performing multiple tests in one test and transmitting this data for storage and Beerling et al. shows the transmission and storage of medical testing data.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Aminoff et al. in view of Meyers et al. in view of Beerling et al. as applied to claims 1 and 11 above, and further in view of Ehrenkranz et al. (US 20130273528 A1; cited in IDS received 02 October 2023).
Claims 8 and 18 are directed to wherein a test line of at least one of the plurality of immunoassay test strips includes an antibody suitable for binding with hCG.
Aminoff et al. in view of Meyers et al. in view of Beerling et al. does not show wherein a test line of at least one of the plurality of immunoassay test strips includes an antibody suitable for binding with hCG.
Like Aminoff et al. in view of Meyers et al. in view of Beerling et al., Ehrenkranz et al. shows point-of-care testing utilizing lateral flow immunoassay which involve reactions between antibodies and antigens. Ehrenkranz et al. shows point-of-care testing includes hormone testing for hCG (Ehrenkranz et al. [0002]). Ehrenkranz et al. shows lateral-flow chromatographic immunoassay cassettes may be adapted for assaying a number of different analyte types such as hormone testing (Ehrenkranz et al. [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have substituted one of the test strips in the lateral flow immunoassay test strips of Aminoff et al. in view of Meyers et al. in view of Beerling et al. to be a test strip which detects hCG because Aminoff et al. in view of Meyers et al. in view of Beerling et al. and Ehrenkranz et al. shows a lateral flow immunoassay for the detection of analytes and would lead to predictable results of assigning test results of a sample for storage in a database in a server accessible by a healthcare provider.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Aminoff et al. in view of Meyers et al. in view of Beerling et al. as applied to claims 1 and 11 above, and further in view of Reed et al. (US 20170059566 A1; Effective filling date of 25 August 2016 and cited in IDS received 02 October 2023).
Claims 9 and 19 are directed to wherein a test line of at least one of the plurality of immunoassay test strips includes Zika virus antigen.
Aminoff et al. in view of Meyers et al. in view of Beerling et al. does not show wherein a test line of at least one of the plurality of immunoassay test strips includes Zika virus antigen.
Like Aminoff et al. in view of Meyers et al. in view of Beerling et al., Reed et al. shows utilizing test strips in analyzing biological samples. Reed et al. shows that immobilizing species of an infectious agent on a test strip to detect distinct antibodies raised against the same infectious agent (Reed et al. [0094]). Reed et al. shows a test strip for detection and differentiation of IgA and IgG associated with Zika virus (Reed et al. [0102]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have substituted one of the test strips in the lateral flow immunoassay test strips of Aminoff et al. in view of Meyers et al. in view of Beerling et al. to be a test strip which detects and differentiation of IgA and IgG associated with Zika virus because Aminoff et al. in view of Meyers et al. in view of Beerling et al. and Reed et al. shows an immunoassay for the detection of analytes and would lead to predictable results of assigning test results of a sample for storage in a database in a server accessible by a healthcare provider.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Aminoff et al. in view of Meyers et al. in view of Beerling et al. as applied to claims 1 and 11 above, and further in view of Reed et al. (US 20170059566 A1; Effective filling date of 25 August 2016 and cited in IDS received 02 October 2023) in view of Ehrenkranz et al. (US 20130273528 A1; cited in IDS received 02 October 2023).
Claims 10 and 20 is directed to wherein a test line of one of the plurality of immunoassay test strips includes Zika virus antigen and the test line of another one of the plurality of immunoassay test strips includes an antibody suitable for binding with hCG.
Aminoff et al. in view of Meyers et al. in view of Beerling et al. does not show wherein a test line of at least one of the plurality of immunoassay test strips includes Zika virus antigen and the test line of another one of the plurality of immunoassay test strips includes an antibody suitable for binding with hCG.
Like Aminoff et al. in view of Meyers et al. in view of Beerling et al., Reed et al. shows utilizing test strips in analyzing biological samples. Reed et al. shows that immobilizing species of an infectious agent on a test strip to detect distinct antibodies raised against the same infectious agent (Reed et al. [0094]). Reed et al. shows a test strip for detection and differentiation of IgA and IgG associated with Zika virus (Reed et al. [0102]).
Aminoff et al. in view of Meyers et al. in view of Beerling et al. in view of Reed et al. the test line of another one of the plurality of immunoassay test strips includes an antibody suitable for binding with hCG.
Like Aminoff et al. in view of Meyers et al. in view of Beerling et al. in view of Reed et al., Ehrenkranz et al. shows point-of-care testing utilizing lateral flow immunoassay which involve reactions between antibodies and antigens. Ehrenkranz et al. shows point-of-care testing includes hormone testing for hCG (Ehrenkranz et al. [0002]). Ehrenkranz et al. shows lateral-flow chromatographic immunoassay cassettes may be adapted for assaying a number of different analyte types such as hormone testing and infectious disease testing (Ehrenkranz et al. [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have substituted one of the test strips in the plurality of immunoassay test strips of Aminoff et al. in view of Meyers et al. in view of Beerling et al. to be a test strip which detects and differentiation of IgA and IgG associated with Zika virus because Aminoff et al. in view of Meyers et al. in view of Beerling et al. and Reed et al. shows an immunoassay for the detection of analytes and would lead to predictable results of assigning test results of a sample for storage in a database in a server accessible by a healthcare provider. It would have been further obvious to one of ordinary skill in the art before the effective filling date of the invention to have substituted one of the test strips in the plurality of immunoassay test strips of Aminoff et al. in view of Meyers et al. in view of Beerling et al. to be a test strip which detects hCG because Aminoff et al. in view of Meyers et al. in view of Beerling et al. in view of Reed et al. and Ehrenkranz et al. shows immunoassay for the detection of analytes and would lead to predictable results of assigning test results of a sample for storage in a database in a server accessible by a healthcare provider.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 and 17-20 of U.S. Patent No. 11,567,070 (referred to ‘070 herein) in view of Meyers et al. (US 9,390,237 B2; cited in IDS received 02 October 2023).
Regarding instant claims 1 and 11, ‘070 shows a testing device configured to collect at least one biological sample, including a plurality of immunoassay test strips, wherein the at least one biological sample contacts a sample pad on at least one of the plurality of immune assay test strips (‘070 claim 11 lines 3-6), a server remote from the testing device and disposed on a network, assign correlative values as test results, wherein each test performed on the biological sample is assigned a different correlative value, receive the test results, wherein the server has a database (‘070 claim 11 lines 13-16 and 19-21), assigning a unique identification to the biological sample (‘070 claim 11 lines 22--24), storing the unique identification in a database associated with the server (‘070 claim 11 lines 25-26), storing in the database the test results in association with the unique identification of the biologic sample (‘070 claim 11 lines 27-30) and providing access to the database to healthcare organizations for analysis of the test results (‘070 claim 11 lines 43-44)
‘070 does not show the testing device includes an alignment target or a method of utilizing this system.
Like ‘070, Meyers et al. shows a testing device which includes a plurality of test strips configured to receive biological samples and a remote server for storing testing results. Meyers et al. shows a test device which includes one or more optical registration marks for allowing the position and/or orientation of the test device to be determined by the reading device (Meyers et al. col. 4 lines 8-14). Meyers et al. shows performing a method which utilizes a system with testing device with test strips and a remote server for storing the test results (Meyers et al. Fig. 3 and col. 6 - col. 7).
Regarding instant claims 2-4 and 12-14, ‘070 shows the testing device is configured to bind antigens or antibodies of an immune complex to antigens or antibodies included on a control line of a membrane strip (‘070 claim 12), ‘070 shows wherein the control line serves as a control (‘070 claim 13), ‘070 shows wherein the control is a dataset from previously conducted tests stored on the database and accessed by a software application (‘070 claim 14).
Regarding instant claims 5 and 15, ‘070 shows providing a qualitative result (‘070 claim 11 lines 37-38).
Regarding instant claims 6, 7, 16, and 17, ‘070 shows providing a quantitative result (‘070 claim 11 lines 39-42) and ‘070 shows wherein at least one of the one or more quantitative results is a reaction rating (‘070 claim 17).
Regarding instant claims 8-10 and 18-20, ‘070 shows wherein a test line of at least one of the one or more immunoassay test strips includes an antibody suitable for binding with hCG (‘070 claim 18), ‘070 shows wherein a test line of at least one of the one or more immunoassay test strips includes Zika virus antigen (‘070 claim 19), and ‘070 shows wherein a test line of one of the one or more immunoassay test strips includes Zika virus antigen and the test line of another one of the one or more immunoassay test strips includes an antibody suitable for binding with hCG (‘070 claim 20).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified the testing device of ‘070 to incorporate the optical registration marks of Meyers et al. because this allows for position and/or orientation of the test device to be determined by the reading device (Meyers et al. col. 4 lines 8-14). It would have been further obvious to one of ordinary skill in the art before the effective filling date of the invention to have utilized the system that performs the functions as shown in ‘070 in a method which utilizes the system which is shown by Meyers et al. by providing a method of utilizing a system of a testing device and remote server for collecting test results for a biological sample and storing on a remote server. One would have a reasonable expectation of success because both ‘070 and Meyers et al. shows a testing device with a plurality of test strips which are imaged to collect test results of a sample.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/J.E.H./Examiner, Art Unit 1685
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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