DETAILED ACTION
This action is made in response to the amendments/remarks filed on July 17, 2026. This action is made final.
Claims 1-4, 7, 9, 11, 13, 15, 16, 18, and 20-28 are pending. Claims 1, 11, 20, 22, and 24 have been amended. Claims 5, 6, 8, 10, 12, and 14 were previously cancelled. Claims 17 and 19 are presently cancelled. Claims 27 and 28 are newly added. Claims 1 and 11 are independent claims.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed July 17, 2026 has been fully considered but is not persuasive.
Applicant argues the previously cited reference of Anhold fails to teach the newly added limitation of “an internal database storing historical data associated with the patient”. However, the examiner, respectfully disagrees.
Anhold teaches a point of use device that can collect and evaluate biological samples, additional objective and/or subjective observations, and historical medical information to generate performance indications such as whether a patient is in good or poor health (e.g., see Abstract). While Anhold teaches a system can utilize an online cloud computing database, Anhold nonetheless, additionally teaches that the amalgamation of the collected data can be maintained on multiple devices, cloud computing, or a single device, such as the point of use device (e.g., see 16:61-67). Accordingly, Anhold teaches the claimed limitation.
Applicant further argues the presenting of the historical data that is taught in Anhold is not analogous to “determine the clinical decision support information”. However, the examiner, respectfully disagrees. As a first matter, the broadest reasonable interpretation of “clinical decision support information” is any type of data that suggests or provides assistance for clinical decisions (see Merriam Webster dictionary of “support”). Accordingly, where the prior art teaches using biomarkers, external data, tests results, historical data, and the indication to determine data that is relevant or aids in clinical decisions unique to the individual, then it meets the claimed limitation. Adding context to the results is a type of data that aids (i.e., supports) clinical decisions. Furthermore, Anhold teaches the use of biological data samples, additional objective and/or subjective observations, and historical medical information to determine whether a patient is in good or poor health as well as to identify trends and suggest diagnosis and/or treatments (e.g., see 13:59-14:3), wherein the health prediction and trends reasonably read upon Applicant’s specification of various examples of clinical support information such as health prediction information (e.g., see Spec 8:1-5). As such, Anhold reads upon the claimed limitation.
Accordingly, for at least the reasons stated above, Applicant’s argument and amendments are not persuasive.
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.
Claim(s) 1-4, 7, 9, 11, 13, and 15-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anhold (USPN: 10,867,701; hereinafter Anhold) in further view of Young et al. (USPN: 11,360,107; hereinafter Young) and Mynhier et al. (USPPN: 2016/0210427; hereinafter Mynhier).
As to claim 1, Anhold teaches A Point-of-Care (POC) testing device configured to provide clinical decision support information to a user (e.g., see Title), the POC testing device comprising:
an output display (e.g., see Figs. 4, 8, 14);
capture biomarkers from the user (e.g., see 13:47-51 teaching collecting various physiological data of a patient, (i.e., digital biomarkers));
an internal database storing historical data associated with the patient (e.g., see 16:61-67 wherein the collected data, including historical data, can be stored on a single device)
a testing module (e.g., see Fig. 14, 13:18-22 teaching an analysis software and/or logic to conduct tests), configured to:
generate test requests by processing biological sample obtained from the patient (e.g., see Fig. 14, 4:40-58, 7:10-12, 13:18-22 wherein a user can conduct tests using biological samples on the POC testing device); and
provide the test results from the POC testing device to:
the patient or a different user of the POC testing device (e.g., see Fig. 14, 4:40-58 wherein the results are provided to a user and/or medical professional), and
a clinical decision support module, integrated into the POC testing device (e.g., see Figs. 14, 15, 13:27-67 wherein the analysis software logic can be configured to consider such factors as actual sample analysis information, additional physiological data, additional subjective and/or intuitive information, etc.), via an internal interface;
a processor (e.g., see 20:38-40); and
memory storing computer-executable instructions that, when executed by the processor (e.g., see 20:44-55), cause the clinical decision support module to:
receive, via the internal interface, the test results generated by the testing module based on the processing of the biological sample (e.g., see Figs. 14, 15, 13:27-67 wherein the analysis software logic can be configured to consider such factors as actual sample analysis information of the patient (i.e., test results), additional physiological data, additional subjective and/or intuitive information, etc.);
receive the biomarkers captured (e.g., see Figs. 14, 15, 13:27-67 wherein the analysis software logic can be configured to consider patient-specific factors such as actual sample analysis information, additional physiological data, additional subjective and/or intuitive information, etc.);
receive from a plurality of outside data sources, external data via a communication connection (e.g., see Figs. 14-16, 7:60-67, 9:55-63, 10:46-49 teaching receiving historical, documentary, or additional data from external sources);
receive the historical data, associated with the patient, from the internal database of the POC testing device (e.g., see 2:61-63, 7:60-67, 10:22-30, 16:61-67 wherein patient historical information is received, wherein the patient historical data can be maintained on a single device);
determine the clinical decision support information, unique to the patient, based on: the biomarkers received, the external data received from the plurality of outside sources, and the test results generated based on the processing of the biological sample, received from the testing, the historical data, associated with the patient, received from the internal database of the POC testing device (e.g., see 2:48-67, 7:60-67, 9:55-63, 10:22-58, 13:35-67, 16:61-67 teaching using actual test results, blood or other sample analysis, physiological data, subjective and/or intuitive information, and historical data to provide patient-specific intervention strategies and diagnostics, wherein the collected data can be maintained on a single device); and
cause the output display to present the clinical decision support information (e.g., see Figs. 4-5, 14, 13:59-14:4 wherein the results are output on a display).
While Anhold teaches the utilizing data retrieved from multiple sources, wherein patient-specific data such as biological or physiological data can be retrieved, to determine patient specific intervention/diagnostics (i.e., clinical decision support information), Anhold fails to teach the patient-specific data is retrieved via a sensor and further fails to teach receive, via a secondary data feed, an indication of at least one of a quality of the biological sample or a quantity of the biological sample.
However, in the same field of endeavor of measuring and testing patient data, Young teaches at least one sensor configured to capture biomarkers from the user, the at least one sensor comprising one or more of a camera, a fingerprint scanner, or a retinal scanner (e.g., see 135:44-54, 135:13-25 wherein a device can use various sensors to collect biometric information about a subject, the sensors including those to capture the subject’s retina, fingerprint, and/or camera etc.); and determine the clinical support information, unique to the user, using the biomarkers received from the at least one sensor (e.g., see 135:13-25 wherein the biometric information, collected from one or more sensors, is used to diagnosis the subject); receive, via a secondary data feed, an indication of at least one of a quality of the biological sample or a quantity of the biological sample (e.g., see 123:35-61, 125:34-61, 12: 9-18 wherein data indicating quality control assessment is provided to the system).
Accordingly, it would have been obvious to modify Anhold in view of Young before the effective filing date with a reasonable expectation of success. One would have been motivated to make the modification to provide earlier access to higher quality testing information thereby enabling earlier intervention and disease management (e.g., see 1:17-20 of Young).
While Anhold teaches receiving data from a plurality of external sources, Anhold-Young fail to teach harmonizes the external data, from the plurality of diverse outside data sources, by normalizing the external data into a common data protocol, and provides the external data, normalized into the common data protocol, to the clinical decision support module.
However, in the same field of endeavor of healthcare management, Mynhier teaches harmonizes the external data, from the plurality of diverse outside data sources, by normalizing the external data into a common data protocol, and provides the external data, normalized into the common data protocol, to the clinical decision support module (e.g., see Fig. 6, [0130], [0264], [0283], [0284] wherein data from multiple disparate devices and data sources are harmonized into a common language and terminology). Accordingly, it would have been obvious to modify Arnhold-Young in view of Mynhier before the effective filing date of the application with a reasonable expectation of success. One would have been motivated to make the modification to accelerate effective disease management and care by obtaining, storing, analyzing and/or providing access to a wide range of health data (e.g., see [0010]-[0012] of Mynhier)
As to claim 2, the rejection of claim 1 is incorporated. While Anhold teaches a POC testing device and Anhold teaches the capability of supporting new analysis and new tests, they fail to explicitly teach wherein the POC testing device is one of: a glucose meter, a coagulation meter, a blood gas analyzer, or an immune-analyzer (Notably, the particular type of testing is interpreted as an intended use. Applicant is remined that, typically, no patentable distinction is made by an intended use or result unless some structural difference is imposed by the use or result on the structure or material recited in the claim, or some manipulative difference is imposed by the use or result on the action recited in the claim. An intended use generally does not impart a patentable distinction if it merely states an intention or is a description of how the claimed apparatus is to be used (see MPEP 2111.05))).
However, in the same field of endeavor of measuring and testing patient data, Young teaches wherein the POC testing device is one of: a glucose meter, a coagulation meter, a blood gas analyzer, or an immune-analyzer (e.g., see 2:54-3:21 wherein the testing can include numerous procedures including coagulation, clotting time assay, enzymatic assay, immunoassay, etc.). Accordingly, it would have been obvious to modify Anhold in view of Young before the effective filing date with a reasonable expectation of success. One would have been motivated to make the modification to provide earlier access to higher quality testing information thereby enabling earlier intervention and disease management (e.g., see 1:17-20 of Young).
As to claim 3, the rejection of claim 1 is incorporated. Anhold further teaches wherein the clinical decision support information indicates patient dietary recommendations based on one or more of: the test results, real time medication adjustments, medication dosing recommendations, treatment recommendations, diagnosis, or combinations thereof (e.g., see 9:10-16, 13:59-14:4 wherein the recommendation include diagnosis, further testing, and/or treatments).
As to claim 4, the rejection of claim 1 is incorporated. Anhold further teaches wherein the plurality of data sources comprises one or more of: laboratory information systems (LIS), hospital information systems (HIS), or repositories of electronic medical records (EMR) data (e.g., see Figs. 12, 13, 16, 12:57-63, 13:59-67 wherein the external sources include other databases storing medical information).
As to claim 7, the rejection of claim 1 is incorporated. Anhold further teaches receive, via the secondary data feed, real world data associated with the patient, wherein the real world data comprises one or more of patient dietary data, patient health measurements, personal patient biomarker data, vital signs of the patient, or patient sleep cycle data, and determine the clinical decision support information based further on the real world data (e.g., see Fig 12, 9:5-16, 13:47-51, 15:13-20 teaching a user interface for receiving real-world data including medication, nutritional information, exercise information, additional biological sample diagnostic information, sleep information, etc. for diagnosing. Notably, the particular type of data is interpreted as an intended use. Applicant is remined that, typically, no patentable distinction is made by an intended use or result unless some structural difference is imposed by the use or result on the structure or material recited in the claim, or some manipulative difference is imposed by the use or result on the action recited in the claim. An intended use generally does not impart a patentable distinction if it merely states an intention or is a description of how the claimed apparatus is to be used (see MPEP 2111.05)))
As to claim 9, the rejection of claim 1 is incorporated. Anhold further teaches wherein the clinical decision support information indicates at least one of changes in a testing routine, treatment advice, or health prediction information (e.g., see 13:65-67 wherein the recommendation include diagnosis, further testing, and/or treatments).
As to claim 11, 13, and 15, the claims are directed to the computer-implemented method provided on the device of claims 1, 7, and 4 and are similarly rejected.
As to claim 16, the rejection of claim 11 is incorporated. Anhold further teaches wherein the plurality of data sources comprises one or more diagnostic devices different from the POC testing device (e.g., see Fig. 12, 12:37-45 wherein an external data source includes other diagnostic and/or analysis devices).
As to claim 18, the rejection of claim 1 is incorporated. Anhold further teaches wherein the plurality of data sources comprises one or more diagnostic devices different from the POC testing device (e.g., see Fig. 12, 12:37-45 wherein an external data source includes other diagnostic and/or analysis devices).
As to claim 20, the rejection of claim 1 is incorporated. Anhold further teaches a second interface, different from the internal interface between the testing module and the clinical decision support module, that is configured to exchange data between one or more of: the patient of the different user, the internal database of the POC testing device, or the secondary data feed associated with the communication connection (e.g., see Figs. 12-16, 18-22 illustrating various configurations of the POC testing device with multiple interfaces for communicating between a user, internal database, or external database).
As to claim 21, the rejection of claim 1 is incorporated. Anhold further teaches wherein the memory stores second computer-executable instructions associated with the testing module that, when executed by the processor, cause the testing module to generate the test results based on the processing of the biological sample (e.g., see 13:7-23 wherein the analysis logic are performed using the samples).
As to claim 22, the rejection of claim 1 is incorporated. Anhold further teaches wherein: the external data, received from the plurality of data sources, comprises body temperature data, and the clinical decision support module is configured to determine the clinical decision support information based on the digital biomarkers, the external data, the test results, the historical data, and the body temperature data (e.g., see 2:48-67, 7:60-67, 9:55-63, 10:22-58, 13:35-67, teaching using actual test results, blood or other sample analysis, physiological data, body temperature, subjective and/or intuitive information, and historical data to provide patient-specific intervention strategies and diagnostics).
While Anhold teaches the use of a plurality of different data for diagnostic purposes, Anhold fails to teach the clinical decision support is based on the indication of the at least one of the quality of the biological sample or the quantity of the biological sample.
However, in the same field of endeavor of measuring and testing patient data, Young teaches the clinical decision support is based on the indication of the at least one of the quality of the biological -sample or the quantity of the biological -sample (e.g., see 123:35-61, 125:34-61, 126:9-18, 127:9-18 wherein the data use for diagnosis further includes quality control assessment).
Accordingly, it would have been obvious to modify Anhold in view of Young before the effective filing date with a reasonable expectation of success. One would have been motivated to make the modification to provide earlier access to higher quality testing information thereby enabling earlier intervention and disease management (e.g., see 1:17-20 of Young).
As to claim 23, the rejection of claim 1 is incorporated. Anhold further teaches the biomarkers captured by the at least one sensor are different than the test results determined via the processing of the biological sample (e.g., see Figs. 15, 16, 13:7-22, 35-67 wherein a blood sample or other sample analysis information can be used for the testing and further teaching additional information such as physiological or subjective information being received through different means).
As to claim 24, the rejection of claim 1 is incorporated. Anhold-Young-Mynhier further teach wherein the POC testing device is configured to: function as a data hub that collects a set of patient data comprising: the biomarkers received from the at least one sensor of the POC testing device, the external data, normalized into the common data protocol, received from the plurality of diverse outside data sources, and the test results received from the testing module of the POC testing device, the historical data received from the internal database of the POC testing device, and the indication, received via the secondary data feed, of the at least one of the quality of the biological sample or the quantity of the biological sample, and use all of the set of patient data, collected via the POC testing device that is functioning as the data hub to determine the clinical decision support information via the clinical support decision module integrated into the POC testing device (e.g., see Abstract, 2:48-67, 7:60-67, 9:55-63, 10:22-58, 13:35-67, 16:61-67 of Anhold teaching a POC testing device which uses blood or other sample analysis, test results/analysis, physiological data, subjective and/or intuitive information, and historical data to provide patient-specific intervention strategies and diagnostics. See also rejection above citing Young for teaching a sensor for collecting biomarker data and data indicating quality of the data and Mynhier for teaching harmonizing the data from a plurality of sources).
As to claim 25, the rejection of claim 1 is incorporated. Young further teaches wherein the indication of the at least one of the quality of the biological sample or the quantity of the biological sample comprises data captured by the camera of the POC testing device (e.g., see 123:35-61, 125:34-61, 126:9-18, 127:9-18 teaching a camera for quality control assessment).
As to claim 26, the rejection of claim 18 is incorporated. Anhold further teaches wherein the one or more diagnostic devices different from the POC testing device, in the plurality of diverse outside data sources, comprises at least one of a glucose monitoring system, a heart rate monitor, or a body temperature monitor configured to monitor vital health signals of the patient (e.g., see 13:48-21, 16:47-55 wherein additional testing devices can be used to capture heart rate, body temperature, etc.).
As to claim 27, the rejection of claim 1 is incorporated. Anhold further teaches wherein the historical data, stored in the internal database, comprises previous test results generated by the testing module of the POC testing device based on processing of one or more additional biological samples obtained from the patient (e.g., see 10:46-48 wherein the historical data can include historical test results, such as those obtained from the patient’s blood or other samples).
As to claim 28, the rejection of claim 7 is incorporated. Anhold further teaches a user interface of the POC testing device that is configured to: receive the real world data from the patient or the different user; and provide the real world data to the clinical decision support module via the secondary data feed (e.g., see Figs. 4, 12, 20, 6:1-6 teaching a user interface for transmitting and presenting data).
Relevant Art not Cited
As a courtesy, the following prior art documents have been found during the course of examination and deemed relevant to applicant’s disclosure. Applicant is strongly encouraged to review the following references prior to any amendments/remarks:
McNair et al. (USPN: 12,020,814): User interface for clinical decision support
Hall et al. (USPPN: 2018/0277240): System and method for generating a patient test data processing code
Dicks et al. (USPN: 9,974,492): Health monitoring and communications device
It is noted that any citation to specific pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Further, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/STELLA HIGGS/Primary Examiner, Art Unit 3686
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