DETAILED ACTION
This action is made in response to the amendments/remarks filed on October 27, 2025. This action is made final.
Claims 1-7, 9 and 11-24 are pending. Claims 1, 5, and 11-17 have been amended. Claims 8, 10 was previously cancelled. Claims 5 and 12 are presently cancelled. Claims 23 and 24 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 October 27, 2025 with respect to the 103 rejection has been considered, but are not persuasive.
Applicant argues the prior art references of Anhold and Lynn fail to teach “determining, by the clinical decision support module, the clinical decision support information, unique to the user, based on the test results received from the testing module, the digital biomarkers received from the at least one sensor, and the external data received from the plurality of data sources”. However, the examiner, respectfully disagrees.
As a first matter, the broadest reasonable interpretation (BRI) of “clinical decision support information” includes patient care-related information such as treatment suggestions, diagnostics, etc., which is consistent with at least Applicant’s originally filed specification 8:3-6. Additionally, Applicant’s originally filed specification does not describe “digital biomarkers”, but merely states they can be captured using sensors such as cameras, fingerprint scanners, retinal scanners, breathalyzers, etc. and further states patient biomarker data can be acquired by those same sensors, wherein patient real world data can be used by the clinical decision support module to provide clinical support specifically tailored to the user (e.g., see 14:1-6).
Anhold is directed to a system/method for optimizing patient-specific intervention strategies using point of care diagnostics, wherein the system retrieves patient data from the point of care device and/or external sources to provide patient-specific performance indications and/or intervention strategies (e.g., see Abstract). Anhold further teaches patient-specific data including their physiological data (i.e., biomarker) or biological data, additional data from external sources (i.e., external data), and test result can be included in generating the customized patient results (e.g., see Figs. 14, 15, 7:60-67, 9:4-16; 13:27-14:3). Accordingly, contrary to Applicant’s assertions, Anhold teaches a point of care device that retrieves patient specific data including physiological (i.e., biomarkers), biological data, external data such as EHR and historical data (i.e., external data), and the test results from the testing module (i.e., test results). While Anhold teaches retrieving physiological data (i.e., biomarker) from a device (e.g., see 13:47-52), Anhold fails to explicitly teach retrieving the data from at least one sensor comprising one or more of a camera, a fingerprint scanner, or a retinal scanner.
However, in the same field of endeavor of measuring and testing patient data, Lynn teaches “at least one sensor comprising one or more of a camera, a fingerprint scanner, or a retinal scanner” (e.g., see 15:21-31 teaching a plurality of sensors for capture biomarker data in point of care testing device through the use of one or more cameras or fingerprint devices to associate the testing with the particular person). Accordingly, it would have been obvious to modify Anhold in view of Lynn with a reasonable expectation of success. One would have been motivated to make the modification to quickly and easily obtain biomarkers relating to various diseases or conditions in a non-invasive manner (e.g., see Abstract of Lynn). Notably, the claims, nor specification, recite how the digital biomarkers received from the camera, fingerprint scanner, or retinal scanner, are used for the clinical support information. Accordingly, where both Anhold and Lynn teach retrieving user-specific data, wherein Anhold explicitly teaches providing patient-specific intervention/diagnostics (i.e., clinical support information, unique to a user…) using patient-specific data, including testing data, physiological data, and data from a plurality of sources and Lynn explicitly teaches the retrieval of the data via one or more of a camera, fingerprint scanner, or a retinal scanner, Anhold-Lynn read upon the claimed limitation.
Applicant’s arguments with respect to the newly amended claim limitation are moot in light of the new grounds of rejection. Newly cited Mynhier is incorporated for teaching the newly added limitation of harmonizes the external data, from the plurality of diverse outside data sources.
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, 3-5, 7, 9, 11-13, and 15-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anhold (USPN: 10,867,701; hereinafter Anhold) in further view of Lynn et al. (USPN: 11,821,821; hereinafter Lynn) 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 (See 112 rejection above. e.g., see 13:47-51 teaching collecting various physiological data of a patient, (i.e., digital biomarkers));
a testing module (e.g., see Fig. 14, 13:18-22 teaching an analysis software and/or logic to conduct tests), configured to:
request tests from the user to the POC testing device (e.g., see Fig. 14, 4:40-58, 7:10-12, 13:18-22 wherein a user can conduct tests on the POC testing device); and
send completed test results from the POC testing device to:
the user (e.g., see Fig. 14, 4:40-58 wherein the results are provided to the user), 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 completed test results from the testing module (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.);
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);
determine the clinical decision support information, unique to the user, based on: the biomarkers received, the external data received from the plurality of outside sources, and the completed test results received from the testing (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, subjective and/or intuitive information, and historical data to provide patient-specific intervention strategies and diagnostics); 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.
However, in the same field of endeavor of measuring and testing patient data, Lynn 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; and determine the clinical support information, unique to the user, using the biomarkers received from the at least one sensor (e.g., see 15:21-31 teaching a plurality of sensors for capture biomarker data in point of care testing device through the use of one or more cameras or fingerprint devices to associate the testing with the particular person. Notably, the claims, nor specification, recite in what capacity the biomarkers received from the camera, fingerprint scanner, or retinal scanner, are used for the clinical support information. Accordingly, where both Anhold and Lynn teach retrieving user-specific data, wherein Anhold explicitly teaches providing patient-specific intervention/diagnostics (i.e., clinical support information, unique to a user…) using patient-specific data, including test result data, physiological data, and data from a plurality of sources and Lynn explicitly teaches the retrieval of the data via one or more of a camera, fingerprint scanner, or a retinal scanner and that said data is further used to associate the test results with a particular person (i.e., clinical support information, unique to a user), Anhold-Lynn read upon the claimed limitation). Accordingly, it would have been obvious to modify Anhold in view of Lynn before the effective filing date of the application with a reasonable expectation of success. One would have been motivated to make the modification to quickly and easily obtain biomarkers relating to various diseases or conditions in a non-invasive manner (e.g., see Abstract of Lynn).
While Anhold teaches receiving data from a plurality of external sources, Anhold-Lynn 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-Lynn 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 3, the rejection of claim 1 is incorporated. Anhold further teaches wherein the clinical decision support information comprises patient dietary recommendations based on 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 an interface configured to receive a secondary data feed comprising real world data associated with a 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 (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. 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 comprises 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 11-15, the claims are directed to the computer-implemented method provided on the device of claims 1, 5, 7, 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 17, the rejection of claim 11 is incorporated. Anhold further teaches wherein the POC testing device comprises an internal historical data associated with the user, and the method further includes: receiving, by the clinical decision support module, the historical data from the internal database via the communication connection; and determining, by the clinical decision support module, the clinical decision support information based on the historical data (e.g., see Figs. 14-16, 7:60-67, 9:55-63, 10:46-49 teaching receiving historical, documentary, or additional data which can be stored locally, to provide patient-specific diagnosis or recommendations).
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 19, the rejection of claim 1 is incorporated. Anhold further teaches wherein the POC testing device comprises an internal historical data associated with the user, and the method further includes: receiving, by the clinical decision support module, the historical data from the internal database via the communication connection; and determining, by the clinical decision support module, the clinical decision support information based on the historical data (e.g., see Figs. 14-16, 7:60-67, 9:55-63, 10:46-49 teaching receiving historical, documentary, or additional data which can be stored locally, to provide patient-specific diagnosis or recommendations).
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 user, an internal databased of the POC testing device, or a 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 determine the completed test results based on the tests (e.g., see 13:17-23 wherein the analysis logic are performed in accordance with the test).
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 completed test results, 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).
As to claim 23, the rejection of claim 1 is incorporated. Anhold further teaches the testing module is configured to determine the completed test results by processing a biological sample, and 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-Lynn-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 completed test results received from the testing module of the POC testing device, 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 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 Lynn for teaching a sensor for collecting biomarker data and Mynhier for teaching harmonizing the data from a plurality of sources).
Claim(s) 2, 6, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anhold, Lynn, and Mynhier, as applied above, and in further view of Kawabata (USPPN: 2015/0247837; hereinafter Kawabata).
As to claim 2, the rejection of claim 1 is incorporated. While Anhold-Lynn teach 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, for the purposes of compact prosecution and in the same field of endeavor of POC testing devices, Kawabata 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 [0085] wherein the POC testing device can test for glucose). Accordingly, it would have been obvious to modify Anhold-Lynn in view of Kawabata with a reasonable expectation of success. One would have been motivated to make the modification in order to quickly and easily measure and test blood sugar levels (e.g., see [0007] of Kawabata).
As to claim 6, the rejection of claim 1 is incorporated. While Anhold teaches the system can be connected to a plurality of external data sources and/or devices, Görlinger fails to teach wherein the secondary data feed comprises data regarding the quality and/or quantity of a sample used to acquire the test results of the patient.
However, in the same field of endeavor of measuring and testing patient data, Kawabata teaches wherein the secondary data feed comprises data regarding the quality and/or quantity of a sample used to acquire the test results of the patient (e.g., see Fig. 23, [0138] wherein quality control measurements of a data sample are provided). Accordingly, it would have been obvious to modify Anhold-Lynn in view of Kawabata with a reasonable expectation of success. One would have been motivated to make the modification to obtain more accurate measurement of samples by utilizing quality control measurements (e.g., see [0138] of Kawabata).
As to claim 14, the claim is directed to the method implemented on the device of claim 6 and is similarly rejected.
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