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 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 1-4, 7-14, and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-4, 7-14, and 17-20 are within the four statutory categories, however, as will be shown below, claims 1-4, 7-14, and 17-20 are nonetheless unpatentable under 35 U.S.C. 101.
Claim 1 is representative of the inventive concept and recites:
Claim 1
A system for validated Electronic-Medical-Record (EMR) reporting, comprising:
at least one hardware processor; and at least one computer readable storage device storing instructions for execution by the at least one hardware processor, the instructions, when executed, cause the system to:
access from a storage device a set of measurements of one or more health indicators for one or more patients, the set of measurements comprising values of measurements of the set of measurements;
identify invalid values of measurements and abnormal values of measurements in the set of measurements, wherein identifying invalid values of measurements in the set of measurements comprises determining a value of a measurement of the set of measurements as invalid if the value is not within a predefined range and wherein the identifying of the abnormal values of measurements in the set of measurements comprises evaluating each value of the values of the measurements of the set of measurements based on the medical condition of a patient from whom the respective measurement was taken;
indicate the identified invalid values of measurements and the identified abnormal values of measurements;
and report the set of measurements to an EMR system, wherein the reporting comprises:
for each measurement having an invalid value, reporting the measurement to the EMR system only after a valid value is received for the measurement and the invalid value is replaced by the valid value, and for each measurement having an abnormal value, reporting the measurement to the EMR system only after the abnormal value is approved by a user having an adequate permission or a normal value is received for the measurement and the abnormal value is replaced by the normal value.
*Claim 11 recites similar limitations as claim 1
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the
highlighted components can practically be performed by the human mind (in this case, the process of
identifying and indicating) or using pen and paper. Other than reciting generic computer components/functions such as “system”, “at least one hardware processor; and at least one computer readable storage device storing instructions for execution by the at least one hardware processor”, and “storage device”, nothing in the claims precludes the highlighted portions from practically being performed in the mind. For example, in claim 1, but for the generic computer language, the claim encompasses the user collecting data, make a prediction utilizing the data, and act on the prediction. If a claim limitation, under its broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components/functions, then it falls within “Mental Processes” grouping of abstract ideas. Additionally, the mere nominal recitation of a generic computer does not take the claim limitation out of the mental process grouping. Thus, the claim recites a mental process. The recitation of generic computer components/functions of indicating also covers behavioral or interactions between people (i.e. a computer), and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case a person is able to physically follow the steps to follow a plan), hence the claim falls under “Certain Methods of Organizing Human Activity”. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Step 2A Prong Two
This judicial exception is no integrated into a practical application. In particular, the claims recite the
following additional limitations:
Claim 1 recites: “system”, “access from a storage device a set of measurements of one or more health indicators for one or more patients, the set of measurements comprising values of measurements of the set of measurements”, “at least one hardware processor; and at least one computer readable storage device storing instructions for execution by the at least one hardware processor”, and “and report the set of measurements to an EMR system, wherein the reporting comprises: for each measurement having an invalid value, reporting the measurement to the EMR system only after a valid value is received for the measurement and the invalid value is replaced by the valid value, and for each measurement having an abnormal value, reporting the measurement to the EMR system only after the abnormal value is approved by a user having an adequate permission or a normal value is received for the measurement and the abnormal value is replaced by the normal value.” ,
In particular, the additional elements do no integrate the abstract idea into a practical application, other
than the abstract idea per se, because the additional elements amount to no more than limitations
which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations
are recited as being performed by a “system”, “at least one hardware processor; and at least one computer readable storage device storing instructions for execution by the at least one hardware processor”, and “storage device”. A computer is recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer.
Add insignificant extra-solution activity (MPEP 2106.05(g)) to the abstract idea such as the
recitation of “and report the set of measurements to an EMR system, wherein the reporting comprises: for each measurement having an invalid value, reporting the measurement to the EMR system only after a valid value is received for the measurement and the invalid value is replaced by the valid value, and for each measurement having an abnormal value, reporting the measurement to the EMR system only after the abnormal value is approved by a user having an adequate permission or a normal value is received for the measurement and the abnormal value is replaced by the normal value” and “access by a storage device a set of measurements of one or more health indicators for one or more patients, the set of measurements comprising values of measurements of the set of measurements”.
Dependent claims 2-4, 7-10, 12-14, and 17-20 do not include any additional elements beyond those already recited in independent claims 1 and 11, hence do not integrate the aforementioned abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or any other technology. Their collective function merely provides conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
Claims 1 and 11 do not include additional elements that are sufficient to amount to significantly
more than the judicial exception. As discussed above with respect to discussion of integration of the
abstract idea into a practical application, the additional elements: A system in claim 1; amount to no
more than mere instructions to apply an exception to the abstract idea. Additionally, the additional
limitations, other than the abstract idea per se amount to no more than limitations which amount to
elements that have been recognized as well-understood, routine, and conventional activity in particular
fields as demonstrated by the recitation of an additional element such as:
Reporting, which refers to the process of sending information over a communication channel
(TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. Cir.
2016)) in a manner that would be well-understood, routine, and conventional.
Accessing, which refers to attaining information over a communication channel or network (TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. Cir.
2016)) in a manner that would be well-understood, routine, and conventional.
Dependent claims 2-4, 7-10, 12-14, and 17-20 include any additional elements beyond those already
addressed above for independent claims 1 and 11. Therefore, they are not deemed to be significantly more than the abstract idea because, as stated above, the limitations of the aforementioned dependent claims amount to no more than generally linking the abstract idea to a particular technological environment or field of use, and/or do not recite and additional elements not already recited in independent claims 1 and 11, hence does not amount to “significantly more” than the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective function merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hasan(US20110246241A1) in view of McEwing(US20200350072A1) Valdes(US20210225469A1).
Claim 1
Hasan discloses:
A system for validated(Para 0029, Hasan discloses an error data system used for validation) Electronic-Medical-Record (Para 0019, Hasan discloses EMR), comprising: at least one hardware processor(Para 0051, Hasan discloses processor); and at least one computer readable storage device storing instructions for execution by the at least one hardware processor(Para 0051, Hasan discloses computer readable instructions), the instructions, when executed, cause the system to: access from a storage device(Para 0026, Hasan discloses a plurality of computers having stored health care data) a set of measurements of one or more health indicators for one or more patients(Para 0052, Hasan discloses access to patient records), the set of measurements comprising values of measurements of the set of measurements(Para 0053, Hasan discloses test results which can be measurement values); identify invalid values of measurements and abnormal values of measurements in the set of measurements(Para 0494, Hasan discloses a rules engine which determines whether data is bad or invalid), (Para 0494, Hasan discloses invalid data that is indicated); and report the set of measurements to an (Para 0508, Hasan discloses PHR population engine, which can be considered an EMR system), wherein the reporting comprises: for each measurement having an invalid value, reporting the measurement to the (Figure 8A, Hasan discloses “health_event_edit”, which is replacing the invalid value with a valid value), and for each measurement having an abnormal value, reporting the measurement to the (Para 0494, Hasan discloses a rules engine which identifies invalid data and sequesters it for review) by a user having an adequate permission(Para 0495, Hasan discloses the incorporation of security to control data access) or a normal value is received for the measurement and the abnormal value is replaced by the normal value(Para 0494, Hasan discloses a rules engine which identifies data and sequesters it for corrective action and reintroduced, if appropriate).
Hasan does not explicitly disclose:
wherein identifying invalid values of measurements in the set of measurements comprises determining a value of a measurement of the set of measurements as invalid if the value is not within a predefined range
and wherein the identifying of the abnormal values of measurements in the set of measurements comprises evaluating each value of the values of the measurements of the set of measurements based on the medical condition of a patient from whom the respective measurement was taken
EMR
McEwing discloses:
wherein identifying invalid values of measurements in the set of measurements comprises determining a value of a measurement of the set of measurements as invalid if the value is not within a predefined range(Para 0272, McEwing discloses identifying test results outside of an accepted range)
EMR(Para 0051, McEwing discloses EMR)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for communication of healthcare data of Hasan to add data determining a value of a measurement of the set of measurements as invalid if the value is not within a predefined range and EMR, as taught by McEwing. One of ordinary skill would have been so motivated to provide a means to bring attention to patient test results that are abnormal so that patient outcomes are improved, but in this case for a method for electronic recording and indexing patient encounters(Para 0006, McEwing discloses: “It will be appreciated that without access to a patient's medical history, the clinician may only treat the observed symptoms in contrast to the underlying problem or cause. “).
McEwing does not disclose:
and wherein the identifying of the abnormal values of measurements in the set of measurements comprises evaluating each value of the values of the measurements of the set of measurements based on the medical condition of a patient from whom the respective measurement was taken
Valdes discloses:
and wherein the identifying of the abnormal values of measurements in the set of measurements comprises evaluating each value of the values of the measurements of the set of measurements based on the medical condition of a patient from whom the respective measurement was taken(Para 0009, Valdes discloses evaluating data in healthcare data record data fields)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for communication of healthcare data of Hasan to add the identification of abnormal values, as taught by Valdes. One of ordinary skill would have been so motivated to provide a means to bring attention to abnormalities in data that need to be addressed, to better improve patient outcomes and diagnosis, but in this case for a system which aggregates healthcare information (Para 0003, Valdes discloses: “Consequently, stakeholders (e.g., patients, insurers, care providers, employers) do not have access to comprehensive datasets that needed to control health outcomes, and consumers historically have not had any access to their own health data.”).
Claim 2
Hasan discloses:
The system according to claim 1, wherein the instructions, when executed, further cause the system, for each measurement having an invalid value, to: request a user to repeat the respective measurement, or allow the user to edit the invalid value(Para 0399, Hasan discloses the correction of invalid data by a provider).
Claim 3
Hasan discloses:
The system according to claim 2, wherein: if the user has an adequate permission(Para 0584, Hasan discloses permissions associated with the PHR), the user is allowed to edit the invalid value(Para 0399, Hasan discloses the correction of invalid data by a provider), and if the user does not have an adequate permission(Figure 10 Hasan indicates revoking permissions), the user is requested to repeat the respective measurement.
Hasan and Valdes do not explicitly disclose:
the user is requested to repeat the respective measurement
Valdes discloses:
the user is requested to repeat the respective measurement(Para 0038, Valdes discloses an alert generated for required data that require follow-up action).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for communication of healthcare data of Hasan to add user repeating a measurement, as taught by Valdes. One of ordinary skill would have been so motivated to provide a means to bring attention to patient testing that needs to be performed as a result of missing or invalid data, to better improve patient outcomes and diagnosis, but in this case for a system which aggregates healthcare information (Para 0003, Valdes discloses: “Consequently, stakeholders (e.g., patients, insurers, care providers, employers) do not have access to comprehensive datasets that needed to control health outcomes, and consumers historically have not had any access to their own health data.”).
Claim 4
Hasan discloses:
The system according to claim 1, wherein the instructions, when executed, further cause the system to allow the approval(Para 0494, Hasan discloses invalid data review which can be approval) or the editing of an abnormal value of a measurement of the set of measurements(Para 0494, Hasan discloses invalid data corrective action, which can be editing) only by a user having an adequate permission(Figure 10, Hasan discloses permissions).
Claim 7
Hasan discloses:
The system according to claim 1, wherein: each patient is associated with a predefined profile of a set of predefined profiles(Para 0035, Hasan discloses an individual health record which can be considered a predefined profile), each profile of the set of predefined profiles comprises one or more ranges of values of one or more measurements of health indicators, each range of values of the one or more ranges of values is defined for a different type of measurement, and evaluating each value of the values of the measurements of the set of measurements comprises determining a value of a measurement of the set of measurements as abnormal if the value of the respective measurement is not within the range of values defined for the respective measurement in the predefined profile of the set of predefined profiles associated with the patient from whom the respective measurement was taken.
Hasan and Valdes do not explicitly disclose:
each profile of the set of predefined profiles comprises one or more ranges of values of one or more measurements of health indicators(Para 0272, McEwing discloses test results which can consist of one or more ranges of values of health indicators), each range of values of the one or more ranges of values is defined for a different type of measurement, and evaluating each value of the values of the measurements of the set of measurements comprises determining a value of a measurement of the set of measurements(Para 0272 McEwing discloses range of test protocols and test results within accepted ranges) as abnormal if the value of the respective measurement is not within the range of values defined for the respective measurement in the predefined profile(Para 0272, McEwing discloses identifying test results outside of an accepted range and classifying or defining the discrepancy) of the set of predefined profiles associated with the patient from whom the respective measurement was taken.
McEwing discloses:
each profile of the set of predefined profiles comprises one or more ranges of values of one or more measurements of health indicators(Para 0272, McEwing discloses test results which can consist of one or more ranges of values of health indicators), each range of values of the one or more ranges of values is defined for a different type of measurement, and evaluating each value of the values of the measurements of the set of measurements comprises determining a value of a measurement of the set of measurements(Para 0272 McEwing discloses range of test protocols and test results within accepted ranges) as abnormal if the value of the respective measurement is not within the range of values defined for the respective measurement in the predefined profile(Para 0272, McEwing discloses identifying test results outside of an accepted range and classifying or defining the discrepancy) of the set of predefined profiles associated with the patient from whom the respective measurement was taken.
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for communication of healthcare data of Hasan to add data determining a value of a measurement of the set of measurements as invalid if the value is not within a predefined range, as taught by McEwing. One of ordinary skill would have been so motivated to provide a means to bring attention to patient test results that are abnormal so that patient outcomes are improved, but in this case for a method of electronic recording and indexing patient encounters(Para 0006, McEwing discloses: “It will be appreciated that without access to a patient's medical history, the clinician may only treat the observed symptoms in contrast to the underlying problem or cause. “).
Claim 8
Hasan and McEwing do not explicitly disclose:
The system according to claim 1, wherein the reporting further comprises, for each measurement of the set of measurements missing a value and of a type defined as an essential type of measurement, reporting the respective measurement to the EMR system only after the lack of value is approved or a value is received for the respective measurement.
Valdes discloses:
The system according to claim 1, wherein the reporting further comprises, for each measurement of the set of measurements missing a value and of a type defined as an essential type of measurement(Para 0007, Valdes discloses identifying missing examination data of patient profile), reporting the respective measurement to the EMR system only after the lack of value is approved or a value is received for the respective measurement(Para 0007, Valdes discloses updating patient profile once the data gap has been filled).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for communication of healthcare data of Hasan to add the identification of missing values and updating the record once the valid values are received, as taught by Valdes. One of ordinary skill would have been so motivated to provide a means to bring attention to missing data that need to be addressed, to better improve patient outcomes and diagnosis, but in this case for a system which aggregates healthcare information (Para 0003, Valdes discloses: “Consequently, stakeholders (e.g., patients, insurers, care providers, employers) do not have access to comprehensive datasets that needed to control health outcomes, and consumers historically have not had any access to their own health data.”).
Claim 9
Hasan discloses:
The system according to claim 8, wherein the instructions, when executed, further cause the system to receive the value for the respective measurement by allowing a user who has an adequate permission to enter the value(Para 0584, Hasan discloses a security module which restricts access based on permissions).
Claim 10
Hasan discloses:
The system according to claim 1, wherein the instructions, when executed, further cause the system to store in the storage device the values of the measurements of the set of measurements except for values which are invalid(Para 0024, Hasan discloses data storage).
Claim 11
Claim 11 contains similar limitations as claim 1. See claim 1 analysis.
Claim 12
Claim 12 contains similar limitations as claim 2. See claim 2 analysis.
Claim 13
Claim 13 contains similar limitations as claim 3. See claim 3 analysis.
Claim 14
Claim 14 contains similar limitations as claim 4. See claim 4 analysis.
Claim 17
Claim 17 contains similar limitations as claim 7. See claim 7 analysis.
Claim 18
Claim 18 contains similar limitations as claim 7. See claim 7 analysis.
Claim 19
Claim 19 contains similar limitations as claim 8. See claim 8 analysis.
Claim 20
Claim 20 contains similar limitations as claim 10. See claim 10 analysis.
Response to Arguments
Rejection under 35 U.S.C. 101
(Pages 7-12) Regarding the assertion that amended claims as a whole integrates the abstract idea into a practical application
Applicant's arguments filed have been fully considered but they are not persuasive. The amended claim as a whole does not integrate into a practical application because the additional elements of accessing and reporting do not recite a specific improvement, thus the amended claim is not eligible because it is not directed to the recited judicial exception or abstract idea. The amendments merely add to the abstract idea of mental processes and organizing human activity.
Rejection under 35 U.S.C. 102
(Pages 14-17) Regarding the assertion that Hassan does not teach the amended abnormal/invalid values of physiological impossible measurements.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
(Page 15) Regarding the assertion of Examiner misreading the text that Hasan “indicates” invalid and abnormal values though paragraph 0494.
Applicant's arguments filed have been fully considered but they are not persuasive. The claims are written broadly and there is no definition of the “indication” as specified in the arguments in the claims. Therefore, when interpreted under BRI, Hasan does teach the indication of invalid and abnormal values.
(Page 15-16) Regarding the assertion that PHR is not the same as an EMR system.
Applicant’s arguments with respect to the rejection(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McEwing.
(Page 17) Regarding the assertion that the claimed invention requires reporting validated physiological measurement data to an EMR.
Applicant's arguments filed have been fully considered but they are not persuasive. Although the reporting is performed to an EMR system, merely defining the receiving system does not absolve the claim of the application of prior art via a 103 rejection. Please refer to 103 analysis above.
Rejection under 35 U.S.C. 103
(Pages 18-20) There is no teaching of determining whether a vital-sign value is physiologically impossible or out of a medically acceptable range, no comparison to predefined physiological ranges, and no requirement to repeat a measurement or obtain a replacement value before reporting.
Applicant's arguments filed have been fully considered but they are not persuasive. The claims are written so broadly, which leaves room for equally broad interpretation under BRI. The argued justifications for this alleged lack of teaching requires reading the specifications into the claims.
(Pages 20-23) Valdes does not examine the numerical values of physiological measurements to decide whether they are clinically invalid or abnormal, does not compare such values against predefined physiological ranges, and does not condition storage or reporting of individual measurements on such comparisons.
Applicant's arguments filed have been fully considered but they are not persuasive. The claims are written so broadly, which leaves room for equally broad interpretation under BRI. The argued justifications for this alleged lack of teaching requires reading the specifications into the claims.
(Pages 23-25) The combination of Hasan, Valdes, and McEwing does not teach or suggest the predefined clinical profiles with per-measurement ranges and profile-based abnormality detection recited in the claims.
Applicant's arguments filed have been fully considered but they are not persuasive. The claims are written so broadly, which leaves room for equally broad interpretation under BRI. The argued justifications for this alleged lack of teaching requires reading the specifications into the claims.
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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/S.G.P./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
Prosecution Insights