DETAILED ACTION
The present office action represents a final action on the merits.
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 .
Priority
This application claims the priority date of 371 of PCT/EP2020/082796 of November 20, 2020 and Provisional Application 62/940,390 of November 26, 2019.
Status of Claims
Claims 1, 4-5, 16, and 19 are amended, Claim 3 is cancelled, and Claims 1, 4-16, and 18-20 are pending.
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, 4-16, and 18-20 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.
Claims 1, 4-15 are drawn to an apparatus for recommending medical tests for a patient, which is within the four statutory categories (i.e., machine), 16 and 18 are drawn to a non-transitory computer readable medium storing instructions, which is within the four statutory categories (i.e., machine), 19-20 are drawn to a method for recommending medical tests for a patient, which is within the four statutory categories (i.e., process).
Claim 1 recites an apparatus for recommending medical tests for a patient, the apparatus including:
at least one electronic processor programmed to:
retrieve patient data stored in a database;
compare the patient data with guidelines for a plurality of medical tests and identify multiple recommended medical tests of the plurality of medical tests based on the comparison, the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement, the at least one complement comprising information that is missing from the patient data and that, if available, would enable execution of the at least one recommended medical test;
perform the currently executable recommended medical test using the available information to generate a test result; and
output, on at least one display device, the test result and a recommendation for the patient to undergo the at least one recommended medical test, wherein the output further includes an identification of the missing information that, if available, would enable execution of the at least one recommended medical test.
Claim 16 recites a non-transitory computer readable medium storing instructions executable by at least one electronic processor to perform a method of recommending medical tests for a patient, the method including:
retrieving patient data stored in a database;
comparing the patient data with guidelines for a plurality of medical tests, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement, the at least one complement comprising information that is missing from the patient data and that, if available, would enable execution of the at least one recommended medical test;
identifying multiple recommended medical tests of the plurality of medical tests based on the comparison, the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test;
ranking the multiple recommended medical tests based on one or more ranking criteria;
performing the currently executable recommended medical test using the available information to generate a test result; and
outputting, on at least one display device, a list of multiple recommendations for the patient to undergo the multiple recommended medical tests according to the one or more ranking criteria, wherein the output further includes the test result and an identification of the missing information that, if available, would enable execution of the at least one recommended medical test.
Claim 19 recites a method for recommending medical tests for a patient, the method including:
retrieving patient data stored in a database;
comparing the patient data with guidelines for a plurality of medical tests, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement, the at least one complement comprising information that is missing from the patient data and that, if available, would enable execution of the at least one recommended medical test;
identifying multiple recommended medical tests of the plurality of medical tests based on the comparison, the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test;
generating a user interface showing at least two of:
a recommendation of the at least one recommended medical test, currently available patient data stored in the electronic medical record database, and additional data needed to complete the at least one recommended medical test;
performing the currently executable recommended medical test using the available information to generate a test result; and
transmitting at least the recommendation and the test result to one or more of the patient, a doctor of the patient, and an insurance company of the patient.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites limitations that are managing personal behavior or relationships or interactions between people (e.g., retrieve patient data; compare patient data and guidelines for medical tests; managing patient information, in this case recommending medical tests). The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below. If a claim limitation, under its broadest reasonable interpretation, is managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Dependent claims 4-15, 18, and 20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
The dependent claims include additional limitations but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 16, and 19.
The additional elements from claim 1 include:
retrieve patient data stored in a database (apply it, MPEP 2106.05(f)).
The additional elements from claims 1 and 16 include:
on at least one display device (apply it, MPEP 2106.05(f)).
The additional elements from claims 1, 16, and 19 include:
the guidelines are stored in a guidelines database (apply it, MPEP 2106.05(f)).
The additional elements from claims 1, 4-10, 12 include:
wherein the at least one electronic processor is programmed to (apply it, MPEP 2106.05(f)).
The additional elements from claims 11 and 13 include:
generating a user interface showing at least one of (apply it, MPEP 2106.05(f)).
The additional elements from claim 15 include:
comprising a laboratory procedure scheduling system, and the at least one electronic processor is further programmed to (apply it, MPEP 2106.05(f)).
The additional elements from claim 16 include:
non-transitory computer readable medium storing instructions executable by at least one electronic processor to perform a method of recommending medical tests for a patient, the method including (apply it, MPEP 2106.05(f)).
The additional elements from claims 16 and 19 include:
retrieving patient data stored in a database (apply it, MPEP 2106.05(f)).
The additional elements from claim 19 include:
generating a user interface showing at least two of (apply it, MPEP 2106.05(f)).
Furthermore, claims 1, 4-16, 18-20 are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “electronic processor”, “display device”, “user interface”, “scheduling system”, “database”, “computer”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g. see, Specification Paragraphs [0021], [0030]-[0034], [0042]. (See MPEP 2106.05(f));
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) 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 Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., Specification Paragraphs [0025]-[0029] disclose that the additional elements (i.e., interface, computer, processor, database) comprise a plurality of different types of generic computing systems that are configured to perform generic computer that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare).
Dependent 4-15, 18, and 20 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. 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 recommending medical tests or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1, 4-16, and 18-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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, 4-8, 10-11, 14-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Monier (U.S. Pub. No. 2016/0063212 A1) in view of Razmi (U.S. Pub. No. 2013/0226601 A1), Chari (U.S. Pub. No. 2014/0058742 A1), and Sambursky (U.S. Pub. No. 2017/0114392 A1).
Regarding claim 1, Monier discloses an apparatus for recommending medical tests for a patient, the apparatus including:
at least one electronic processor programmed to (Paragraphs [0061]-[0062] discuss at least one processor integrated with programming instructions.):
retrieve patient data stored in a database (Paragraphs [0026]-[0027] and [0045] discuss information retrieval and a patient information store provide access to patient data from electronic medical records in a database.);
note the patient data with guidelines for a plurality of medical tests and identify multiple recommended medical tests of the plurality of medical tests based on the information, and execution of a matching algorithm to determine at least one complement, the at least one complement comprising information that is missing from the patient data and that, if available, would enable execution of the at least one recommended medical test (Paragraphs [0009], [0012], [0029], and [0042] discuss assessing the impact of missing data on a treatment recommendation, providing a recommendation in the presence of incomplete data, prioritizing a list of recommendations based on the quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation and the module parses information in the medical records and associates the parsed information with pre-defined medical features and use medical guideline system and based on patient medical records output ranked medical interventions as recommendations based on medical guidelines, for example, medical guideline can identify an outcome that includes a patient’s testing for a glucose level.); and
output, on at least one display device, the test result and a recommendation for the patient to undergo the at least one recommended medical test, wherein the output further includes an identification of the missing information that, if available, would enable execution of the at least one recommended medical test (Paragraphs [0011], [0041]-[0042], [0059], and FIG. 6 discuss assessing the impact of missing data on a treatment recommendation, providing a recommendation in the presence of incomplete data, prioritizing a list of recommendations based on the quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation and the medical guideline generation system and top ranked interventions are outputted into recommendations for medical guidelines via a personal client device, the method outputs the top recommendation along with the sensitivity of the method with regards to missing data.).
Monier does not explicitly disclose:
compare the patient data with guidelines, based on the comparison, the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement; and
perform the currently executable recommended medical test using the available information to generate a test result.
Razmi teaches:
compare the patient data with guidelines (Paragraph [0074] discusses the system compares a treatment plan against established guidelines to identify any gaps or areas for improvement to provide a diagnosis to treat current issues.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include compare the patient data with guidelines, as taught by Razmi, to allow or more convenient, lower cost, and less frequent, documented visits with a provider which will result in better monitoring and management of chronic conditions. (Razmi Paragraph [0006].).
Chari teaches:
based on the comparison, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement (Paragraphs [0147]-[0148] discuss the guideline module may include a clinical practice guidelines database that stores clinical practice guidelines definitions (CPGDs) and the guideline module may include a patient manager and the patient manager may determine a list of CPGDs and/or their rules that may be relevant for each patient and may also query CPGDs to use one or more inclusion criteria in the CPGDs to determine which CPGDs should be applied to each patient.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include based on the comparison, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement, as taught by Chari, to enable the diagnosis and effective management of patients with chronic diseases and to improve the quality, safety, efficiency of healthcare for Americans. (Chari Paragraphs [0003] and [0005].).
Sambursky teaches:
the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test (Paragraphs [0028] discuss the screen a patient, for example, the first test is performed for a presence of bacteria and if the first test indicated bacteria is present, a second test is performed to quantitatively determine a level of protein in the sample.); and
perform the currently executable recommended medical test using the available information to generate a test result (Paragraph [0019] discusses if the original sample undergoes a first test and if positive for a typical pathogen, a second test is performed.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include, the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test and perform the currently executable recommended medical test using the available information to generate a test result, as taught by Sambursky, to accurately screen for and diagnose viral and bacterial infections and differentiate colonization from active infection. (Sambursky Paragraph [0003].).
Regarding claim 4, Monier discloses wherein the at least one electronic processor is programmed to:
determine supporting information that is missing from the patient data and that, if available, would increase confidence in the test result (Paragraphs [0011] discuss application of clinical treatment guidelines and assessing the impact of missing data on a treatment recommendation, providing a recommendation in the presence of incomplete data, prioritizing a list of recommendations based on the quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation.);
Monier does not explicitly disclose:
wherein the output of the test result includes a recommendation to obtain the supporting information.
Razmi teaches:
wherein the output of the test result includes a recommendation to obtain the supporting information (Paragraphs [0034] and [0073] discuss recommendations and display diagnostic tests and a diagnosis/treatment plan and information related to therapies the patient should be on and that should be avoided.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include wherein the output of the test result includes a recommendation to obtain the supporting information, as taught by Razmi, to allow or more convenient, lower cost, and less frequent, documented visits with a provider which will result in better monitoring and management of chronic conditions. (Razmi Paragraph [0006].).
Regarding claim 5, Monier discloses wherein the at least one electronic processor is programmed to:
rank the multiple recommended medical tests based on one or more ranking criteria (Paragraph [0012] discusses ranking the identified medical interventions and outputting the top ranked medical interventions as recommendations for medical guidelines.).
Regarding claim 6, Monier discloses wherein the at least one electronic processor is programmed to rank the multiple recommended medical tests by operations including:
identifying a ranking criterion of a clinical guideline for each of the recommended tests (Paragraphs [0029], [0032] discuss the determination of medical guidelines may include the most relevant intervening features, and (the features include, the diagnosis of a particular medical disease or disorder, a patient's physiological symptoms, administration of a drug or other medical treatment, e.g. radiation therapy or surgery, for example, the medical condition of “diabetes” is most often associated with the terms “glucose,” “A1c,” Metformin,” and “liver failure,” among others and the feature generation module identifies medical outcomes included in a patient's medical history), and associates with the identified outcomes any features, and the module uses the features to rank the medical intervention recommendations.); and
generating a score for each of the multiple recommended medical tests based on the clinical guideline for each test (Paragraph [0012] discusses ranking the medical interventions based on a score and outputting the top ranked medical interventions as recommendations for medical guidelines.).
Regarding claim 7, Monier discloses wherein the at least one electronic processor is programmed to rank the multiple recommended tests by operations including:
identifying a ranking criterion of pre-conditions or characteristics of the patient identified from the retrieved patient data (Paragraphs [0031]-[0032] discuss selection of features from medical records and ranking patient features with respect to their support and/or confidence.); and
generating a score for each of the multiple recommended medical tests based on the pre-conditions or characteristics of the patient (Paragraph [0040] discusses reviewing patient medical records and the scoring module scores all the interventions included in a patient’s trajectory graph for a medical condition or disorder and generates recommendations for medical guidelines regarding this medical condition or disorder based on the highest scoring interventions.).
Regarding claim 8, Monier discloses wherein the at least one electronic processor is programmed to rank the multiple recommended tests by operations including:
identifying a ranking criterion of additional lab work required to perform each of the multiple recommended medical tests based on the retrieved patient data (Paragraphs [0029]-[0032] discuss selection of features from medical records and ranking patient features with respect to their support and/or confidence and the identified outcome can include a patient’s testing for a glucose level based on features in patient’s medical records.); and
generating a score for each of the multiple recommended medical tests based on the additional lab work required for each test (Paragraphs [0012], [0028] and [0040] discuss reviewing patient medical records that include procedures, laboratory values, and other medical observations and the scoring module scores all the interventions included in a patient’s trajectory graph for a medical condition or disorder and generates recommendations for medical guidelines regarding this medical condition or disorder based on the highest scoring interventions using patient’s medical records.).
Regarding claim 10, Monier discloses wherein the at least one electronic processor is programmed to rank the multiple recommended tests by operations including:
identifying a ranking criterion of a patient already having undergone one of the tests based on the retrieved patient data (Paragraphs [0003], [0005], [0029]-[0032], [0068] discuss selection of features from prior medical records and ranking patient features with respect to their support and/or confidence, the automated diagnosis and testing recommendation assistant accepts past test results and run the data against established criteria.); and
generating a score for the multiple recommended tests based on the patient already having undergone any of the tests (Paragraphs [0012], [0028], [0040], and [0080] discuss reviewing patient medical records that include past procedures, laboratory values, and other medical observations and the scoring module scores all the interventions included in a patient’s trajectory graph for a medical condition or disorder and generates recommendations for medical guidelines regarding this medical condition or disorder based on the highest scoring interventions using patient’s medical records that contain past medical data.).
Regarding claim 11, Monier discloses wherein the output includes:
generating a user interface showing at least one of (Paragraph [0078] discusses providing a data communications interface.):
the recommendation of the at least one recommended medical test, a scope of the at least one recommended medical test, a level of detail for the at least one recommended medical test, currently available patient data stored in the database, and additional data needed to complete the at least one recommended medical test (Paragraphs [0078]-[0080], and FIG. 6 discuss the analyzer interface provides a data communications interface for the current condition data receiver to send data to and receive data from the condition analyzer testing recommender and providing health condition review and diagnosis with testing recommendations and the system compares required data for diagnosis against existing patient data and determines whether data is sufficient.); and
transmitting at least the recommendation to a physician (FIG. 6 discusses report recommendation from results.).
Regarding claim 14, Monier discloses wherein the retrieval of the patient data stored in the database includes:
determining an acquisition date of items of the patient data stored in the database (Paragraph [0028] discusses record processing module processes each medical record stored including identifying date and time when the events described occurred.); and
remove any item of the patient data having an acquisition date that is older than a predetermined time threshold (Paragraph [0031] discusses the module selects all of the features generated from the medical records that span an identical time period and are associated with the same medical condition, and allows for passively removing a feature not in the time period.).
Regarding claim 15, Monier discloses comprising a laboratory procedure scheduling system, and the at least one electronic processor is further programmed to:
physician-ordered laboratory procedure for collecting a blood or tissue specimen from the patient (Paragraph [0029] discusses an outcome can include a patient’s testing for glucose level and a requirement of injection of insulin prior to the glucose test.);
determine missing information that is missing from the patient data and that, if available, would enable execution of the at least one recommended medical test (Paragraphs [0011] and [0042] discuss assessing the impact of missing data on a treatment recommendation and the method outputs the top recommendation along with the sensitivity of the methods with regards to missing data.);
determine an unscheduled hematology or histopathology test that could be performed on the blood or tissue specimen to obtain at least a portion of the missing information (Paragraphs [0011] and [0029] discuss application of clinical treatment guidelines and assessing the impact of missing data on a treatment recommendation, providing a recommendation in the presence of incomplete data, prioritizing a list of recommendations based on the quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation, for example, medical guideline can identify an outcome that includes a patient’s testing for a glucose level.) (Examiner notes that while the art does not explicitly state, “hematology or histopathology test” a glucose test meets the hematology limitation.);
wherein the output of the recommendation for the patient to undergo the at least one recommended medical test includes outputting, on the display device, a recommendation to perform the unscheduled hematology or histopathology test (Paragraphs [0009], [0012], and [0029] discuss the module parses information in the medical records and associates the parsed information with pre-defined medical features and use medical guideline system and based on patient medical records output ranked medical interventions as recommendations based on medical guidelines, for example, medical guideline can identify an outcome that includes a patient’s testing for a glucose level.).
Monier does not explicitly disclose:
schedule a physician-ordered laboratory procedure for collecting a blood or tissue specimen from the patient;
Razmi teaches:
schedule a physician-ordered laboratory procedure for collecting a blood or tissue specimen from the patient (Paragraph [0090] discusses the producer can schedule laboratory tests to rule out certain conditions.)
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include schedule a physician-ordered laboratory procedure for collecting a blood or tissue specimen from the patient, as taught by Razmi, to allow or more convenient, lower cost, and less frequent, documented visits with a provider which will result in better monitoring and management of chronic conditions. (Razmi Paragraph [0006].).
Regarding claim 16, Monier discloses a non-transitory computer readable medium storing instructions executable by at least one electronic processor to perform a method of recommending medical tests for a patient, the method including:
retrieving patient data stored in a database (Paragraphs [0026]-[0027] discuss a patient information store for storing patient medical records and information in a database.);
noting the patient data with guidelines for a plurality of medical tests and execution of a matching algorithm to determine at least one complement, the at least one complement comprising information that is missing from the patient data and that, if available, would enable execution of the at least one recommended medical test (Paragraphs [0009], [0012], [0029], and [0042] discuss assessing the impact of missing data on a treatment recommendation, providing a recommendation in the presence of incomplete data, prioritizing a list of recommendations based on the quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation and the module parses information in the medical records and associates the parsed information with pre-defined medical features and use medical guideline system and based on patient medical records output ranked medical interventions as recommendations based on medical guidelines, for example, medical guideline can identify an outcome that includes a patient’s testing for a glucose level.);
identifying multiple recommended medical tests of the plurality of medical tests based on the comparison, (Paragraphs [0012] discuss identifying medical interventions by parsing medical records and ranking the identified medical interventions based on patients’ features in the medical records.);
ranking the multiple recommended medical tests based on one or more ranking criteria (Paragraph [0012] discusses ranking the identified medical interventions based on the score that is based on.); and
outputting, on at least one display device, a list of multiple recommendations for the patient to undergo the multiple recommended medical tests according to the one or more ranking criteria, wherein the output further includes the test result and an identification of the missing information that, if available, would enable execution of the at least one recommended medical test (Paragraphs [0012], [0041 ]-[0042], [0059], and FIG. 6 discuss assessing the impact of missing data on a treatment recommendation, providing a recommendation in the presence of incomplete data, prioritizing a list of recommendations based on the quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation and outputting the top ranked medical interventions as recommendations for medical guidelines via a client device.).
Monier does not explicitly disclose:
comparing the patient data with guidelines, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement;
the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test;
performing the currently executable recommended medical test using the available information to generate a test result.
Razmi teaches:
comparing the patient data with guidelines. (Paragraph [0074] discusses the system compares a treatment plan against established guidelines to identify any gaps or areas for improvement to provide a diagnosis to treat current issues.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include comparing the patient data with guidelines, as taught by Razmi, to allow or more convenient, lower cost, and less frequent, documented visits with a provider which will result in better monitoring and management of chronic conditions. (Razmi Paragraph [0006].).
Chari teaches:
wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement (Paragraphs [0147]-[0148] discuss the guideline module may include a clinical practice guidelines database that stores clinical practice guidelines definitions (CPGDs) and the guideline module may include a patient manager and the patient manager may determine a list of CPGDs and/or their rules that may be relevant for each patient and may also query CPGDs to use one or more inclusion criteria in the CPGDs to determine which CPGDs should be applied to each patient.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement, as taught by Chari, to enable the diagnosis and effective management of patients with chronic diseases and to improve the quality, safety, efficiency of healthcare for Americans. (Chari Paragraphs [0003] and [0005].).
Sambursky teaches:
the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test (Paragraphs [0028] discuss the screen a patient, for example, the first test is performed for a presence of bacteria and if the first test indicated bacteria is present, a second test is performed to quantitatively determine a level of protein in the sample.); and
performing the currently executable recommended medical test using the available information to generate a test result (Paragraph [0019] discusses if the original sample undergoes a first test and if positive for a typical pathogen, a second test is performed.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include, the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test and performing the currently executable recommended medical test using the available information to generate a test result, as taught by Sambursky, to accurately screen for and diagnose viral and bacterial infections and differentiate colonization from active infection. (Sambursky Paragraph [0003].).
Regarding claim 18, Monier discloses wherein the method further includes:
comparing the patient data with guidelines for the plurality of medical tests (Paragraphs [0009] and [0012] discuss use medical guideline system and based on patient medical records output ranked medical interventions as recommendations for medical guidelines.); and
identifying an executable medical test of the plurality of medical tests based on the comparison for which the available information is sufficient to perform the executable medical test (Paragraphs [0009], [0012], and [0029] discuss use medical guideline system and based on patient medical records output ranked medical interventions as recommendations based on medical guidelines, for example, medical guideline can identify an outcome that includes a patient’s testing for a glucose level.);
performing the executable medical test using the available information to generate a test result (Paragraph [0029] discusses the identified outcome includes patient’s testing for a glucose level based on a review of patient’s medical records and medical guidelines.).
Monier does not explicitly disclose:
outputting, on the at least one display device, the test result.
Razmi teaches:
outputting, on the at least one display device, the test result (Paragraphs [0034] and [0073] discuss an output device and relevant information may be displayed on screens, such as information related to diagnostic tests.)
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include outputting, on the at least one display device, the test result, as taught by Razmi, to allow or more convenient, lower cost, and less frequent, documented visits with a provider which will result in better monitoring and management of chronic conditions. (Razmi Paragraph [0006].).
Claims 9, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Monier in view of Razmi, Chari, and Sambursky and in further view of Dash (U.S. Pub. No. 2020/0377958 A1).
Regarding claim 9, Monier discloses wherein the at least one electronic processor is programmed to rank the recommended tests by operations including:
identifying a ranking criterion of the patient for each test based on the retrieved patient data (Paragraphs [0031]-[0032] discuss selection of features from medical records and ranking patient features with respect to their support and/or confidence.); and
generating a score for the multiple recommended tests based on the criterion of the patient for each test (Paragraph [0040] discusses reviewing patient medical records and the scoring module scores all the interventions included in a patient’s trajectory graph for a medical condition or disorder and generates recommendations for medical guidelines regarding this medical condition or disorder based on the highest scoring interventions.).
Monier does not explicitly disclose:
insurance reimbursement level;
Dash teaches:
insurance reimbursement level (Paragraphs [0149]-[0150] discuss patient information is provided to an insurance company and choice of medical procedure, whether the pay for a medical procedure, payment by a reimbursing party or cost for a service and the amount reimbursed is determined by the insurance company and the premium for insurance is evaluated as a function of information about the patient, premiums are assessed as a function of actuarial data and treatment outcomes.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include insurance reimbursement level, as taught by Dash, in order to provide expedient and accurate treatment based on analytical results for patients likely to have favorable therapeutic outcomes. (Dash Paragraph [0006].).
Regarding claim 13, Monier discloses wherein the output includes:
generating a user interface showing at least one of (Paragraphs [0044], [0061], FIG. 4 discuss interface and computers and devices providing testing recommendations.):
the recommendation of the at least one recommended medical test, currently available patient data stored in the electronic medical record databasthe quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation.); and
transmitting at least the recommendation to a patient (Paragraphs [0059] and [0080] discuss reports recommendations to the treating physician and user may access medical guideline generation system that contains medical interventions as recommendations via a personal client device.).
Monier does not explicitly disclose:
transmitting at least the recommendation to an insurance company of the patient;
Dash teaches:
transmitting at least the recommendation to an insurance company of the patient (Paragraphs [0149]-[0150] discuss patient information is provided to an insurance company and choice of medical procedure, whether the pay for a medical procedure, payment by a reimbursing party or cost for a service and the amount reimbursed is determined by the insurance company and the premium for insurance is evaluated as a function of information about the patient, premiums are assessed as a function of actuarial data and treatment outcomes.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include transmitting at least the recommendation to an insurance company of the patient, as taught by Dash, in order to provide expedient and accurate treatment based on analytical results for patients likely to have favorable therapeutic outcomes. (Dash Paragraph [0006].).
Regarding claim 19, Monier discloses a method for recommending medical tests for a patient, the method including:
retrieving patient data stored in a database (Paragraphs [0026]-[0027] discuss a patient information store for storing patient medical records and information in a database.);
noting the patient data with guidelines for a plurality of medical tests and execution of a matching algorithm to determine at least one complement, the at least one complement comprising information that is missing from the patient data and that, if available, would enable execution of the at least one recommended medical test (Paragraphs [0009], [0012], [0029], and [0042] discuss assessing the impact of missing data on a treatment recommendation, providing a recommendation in the presence of incomplete data, prioritizing a list of recommendations based on the quality of the match between the patient state and the treatment recommendation, and quantifying the confidence in the recommendation and the module parses information in the medical records and associates the parsed information with pre-defined medical features and use medical guideline system and based on patient medical records output ranked medical interventions as recommendations based on medical guidelines, for example, medical guideline can identify an outcome that includes a patient’s testing for a glucose level.);
identifying multiple recommended medical tests of the plurality of medical tests based on the comparison (Paragraphs [0009], [0012], and [0029] discuss use medical guideline system and based on patient medical records output ranked medical interventions as recommendations based on medical guidelines, for example, medical guideline can identify an outcome that includes a patient’s testing for a glucose level.);
a recommendation of the at least one recommended medical test, currently available patient data stored in the electronic medical record database, and additional data needed to complete the at least one recommended medical test (Paragraphs [0078]-[0080], and FIG. 6 discuss the analyzer interface provides a data communications interface for the current condition data receiver to send data to and receive data from the condition analyzer testing recommender and providing health condition review and diagnosis with testing recommendations and the system compares required data for diagnosis against existing patient data and determines whether data is sufficient.); and
transmitting at least the recommendation and the test result to one or more of the patient, a doctor of the patient (Paragraphs [0059] and [0080] discuss reports recommendations to the treating physician and user may access medical guideline generation system that contains medical interventions as recommendations via a client device to a provider or patient.).
Monier does not explicitly disclose:
generating a user interface showing at least two of:
comparing the patient data with guidelines, wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement;
the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test; and
performing the currently executable recommended medical test using the available information to generate a test result; and
transmitting at least the recommendation to an insurance company of the patient.
Razmi teaches:
generating a user interface showing at least two of (Paragraphs [0012], [0034]-[0035] and FIGS. 4-19 discuss dynamically update patient database and display information and utilizing a variety of interfaces for determining a probable diagnosis.):
comparing the patient data with guidelines. (Paragraph [0074] discusses the system compares a treatment plan against established guidelines to identify any gaps or areas for improvement to provide a diagnosis to treat current issues.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include generating a user interface showing at least two and comparing the patient data with guidelines, as taught by Razmi, to allow or more convenient, lower cost, and less frequent, documented visits with a provider which will result in better monitoring and management of chronic conditions. (Razmi Paragraph [0006].).
Chari teaches:
wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement (Paragraphs [0147]-[0148] discuss the guideline module may include a clinical practice guidelines database that stores clinical practice guidelines definitions (CPGDs) and the guideline module may include a patient manager and the patient manager may determine a list of CPGDs and/or their rules that may be relevant for each patient and may also query CPGDs to use one or more inclusion criteria in the CPGDs to determine which CPGDs should be applied to each patient.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include wherein the guidelines are stored in a guidelines database, wherein the comparison further comprises execution of a matching algorithm to determine at least one complement, as taught by Chari, to enable the diagnosis and effective management of patients with chronic diseases and to improve the quality, safety, efficiency of healthcare for Americans. (Chari Paragraphs [0003] and [0005].).
Sambursky teaches:
the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test (Paragraphs [0028] discuss the screen a patient, for example, the first test is performed for a presence of bacteria and if the first test indicated bacteria is present, a second test is performed to quantitatively determine a level of protein in the sample.); and
performing the currently executable recommended medical test using the available information to generate a test result (Paragraph [0019] discusses if the original sample undergoes a first test and if positive for a typical pathogen, a second test is performed.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include, the identification of the multiple recommended medical tests including at least one recommended medical test and a currently executable recommended medical test for which the available information is sufficient to perform the currently executable recommended medical test and performing the currently executable recommended medical test using the available information to generate a test result, as taught by Sambursky, to accurately screen for and diagnose viral and bacterial infections and differentiate colonization from active infection. (Sambursky Paragraph [0003].).
Dash teaches:
transmitting at least the recommendation to an insurance company of the patient (Paragraphs [0149]-[0150] discuss patient information is provided to an insurance company and choice of medical procedure, whether the pay for a medical procedure, payment by a reimbursing party or cost for a service and the amount reimbursed is determined by the insurance company and the premium for insurance is evaluated as a function of information about the patient, premiums are assessed as a function of actuarial data and treatment outcomes.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include transmitting at least the recommendation to an insurance company of the patient, as taught by Dash, in order to provide expedient and accurate treatment based on analytical results for patients likely to have favorable therapeutic outcomes. (Dash Paragraph [0006].).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Monier in view of Razmi, Chari, and Sambursky and in further view of McNair (U.S. Pat. No. 9542532 B1) and Tranah (U.S. Pub. No. 2017/0268057 A1).
Regarding claim 12, Monier discloses wherein the at least one electronic processor is programmed to:
receive an input from the physician (Paragraph [0063]-[0064] discuss send and receive communication from a physician.);
update the user interface (Paragraph [0063] discusses updating the interface provides current information.);
Monier does not explicitly disclose:
indicating rejection of at least one of the recommended medical tests shown on the user interface (Column 15 lines 26-27 discuss logging a user’s acceptance or rejection of a recommendation.); and
remove any rejected test.
McNair teaches:
indicating rejection of at least one of the recommended medical tests shown on the user interface (Column 15 lines 26-27 discuss logging a user’s acceptance or rejection of a recommendation.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include indicating rejection of at least one of the recommended medical tests shown on the user interface, as taught by McNair, in order to provide timely, salient recommendations to clinicians to enhance the quality of care. (McNair Column 2 lines 43-50.).
Tranah teaches:
remove any rejected test (Paragraphs [0074] discusses remove recommendations on the health plan.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include remove any rejected test, as taught by Tranah, in order to provide a treatment protocol. (Tranah Paragraph [0016].).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Monier in view of Razmi, Chari, and Sambursky and in further view of Dash, McNair and Tranah.
Regarding claim 20, Monier discloses further including:
receiving an input from the physician (Paragraph [0063]-[0064] discuss send and receive communication from a physician.); and
updating the user interface (Paragraph [0063] discusses updating the interface provides current information.).
Monier does not explicitly disclose:
indicating rejection of at least one of the recommended medical tests shown on the user interface (Column 15 lines 26-27 discuss logging a user’s acceptance or rejection of a recommendation.); and
remove any rejected test.
McNair teaches:
indicating rejection of at least one of the recommended medical tests shown on the user interface (Column 15 lines 26-27 discuss logging a user’s acceptance or rejection of a recommendation.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include indicating rejection of at least one of the recommended medical tests shown on the user interface, as taught by McNair, in order to provide timely, salient recommendations to clinicians to enhance the quality of care. (McNair Column 2 lines 43-50.).
Tranah teaches:
remove any rejected test (Paragraphs [0074] discusses remove recommendations on the health plan.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Monier to include remove any rejected test, as taught by Tranah, in order to provide a treatment protocol. (Tranah Paragraph [0016].).
Response to Arguments
Applicant’s arguments filed 10/6/2025 have been fully considered.
Rejections under 35 U.S.C. 101:
With respect to claim 1 and the 35 U.S.C. 101 rejection, Applicant’s amendment fails to overcome the previous rejection. Claim 1 as amended recites an abstract idea, a method of organizing human activity. See MPEP 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People. Applicant states, “claim 1 (and similarly, independent claims 16 and 19) recite steps which, through processing by a physical device, transform information stored in one or more databases into actionable steps, including determining certain actions and through the claimed output, present a recommendation of a medical screening test to a physical device for visual display of the same. Thus, Applicant submits that the allegation that such features recite a judicial exception (e.g., managing human activity) is in error and not supported by the rules of the MPEP or underlying case law.” (Remarks, pages 13-14). Applicant further states, “even assuming arguendo that the bolded features can be construed as managing human behavior, the MPEP states that "not all methods of organizing human activity are abstract ideas".” (Remarks, page 14). Applicant states, “allegations above from the Office appear to essentially be that there is no technical problem rooted in technology, and that the claims do not recite a technical improvement. Applicant respectfully disagrees. The Office appears to focus on improvements to a device, whereas MPEP 2106.04(d) and Federal case law specifically, and explicitly, instructs that the improvement may be realized as "[A]n improvement in the functioning of a computer, or an improvement to other technology or technical field" (emphasis added). The technological field of the present disclosure includes the field of medical screening, which is not a business or advertising method, commercial venture, etc., but rather, a technical field.” (Remarks, pages 14-15). Examiner respectfully disagrees. The Application recites the abstract idea of identifying a recommended medical test, which is behavior that a human can do. Applicant states, “FIG 1 of the present disclosure is shown below, which shows technological, physical structures, including an electronic processor, data storage, and computing/communication devices in a network topology.” (Remarks, page 15). Examiner respectfully disagrees. The claimed invention does not provide an improvement in technology. Medical screening -retrieving patient data, comparing the patient data with guidelines for a plurality of medical tests, identifying a recommended medical test and displaying the recommendation, is not a technical problem rooted in the technology. Here, there is no improvement to the apparatus, electronic processor, display device, user interface, scheduling system, computer, database or any other device – the apparatus is used to obtain patient data and output information corresponding to recommended medical test, which itself is not an improvement. Applicant’s claims are directed to gathering information, organizing the information, comparing the information, and presenting the information.
While practical application is a way to overcome the Prong 2 35 U.S.C. 101 rejection, here, claim 1 fails to integrate the recited judicial exception into a practical application. Applicant states, “non-final Office Action (see pages 33-35), in effect, argues that most of the claim (bolded) is abstract and hence does not result in a practical application, whereby all components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. Applicant notes that the August 4, 2025 Memorandum to the Examining Corp emphasizes several factors in the determination of subject matter eligibility. For instance, it is noted that under Section A, the subject matter eligibility guidance is distilled from relevant case law, none of which comport with the present set of claims, as explained above. Also, under Section B of the Memorandum, and in particular, the improvements, "Examiners are cautioned not to oversimplify claim limitations". Applicant respectfully submits that simply summarizing the claim as "identifying a recommended medical test" or distilling the claimed features to "Retrieving patient data, comparing the patient data with guidelines for a plurality of medical tests, identifying a recommended medical test and displaying the recommendation" is the sort of oversimplification the Memorandum cautions against.” (Remarks, pages 20-21). Examiner respectfully disagrees. The "execution of a matching algorithm to determine at least one complement”, does not result in a practical application as it is recited as part of the abstract idea, as stated above. All components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. Here, the improvement is to the abstract idea. For the reasons stated above, claims 16 and 19 similarly fail to overcome the 35 U.S.C. 101 rejection.
Rejections under 35 U.S.C. 103:
With respect to claim 1 and the 35 U.S.C. 103 rejection, Applicant’s amendment overcomes the previous rejection. Using the broadest reasonable interpretation of the claims, Examiner interprets the cited art as including the referenced limitations. Further, Applicant’s arguments with respect to amended claim 1 have been considered and the Examiner’s rejection has been updated to address Applicant’s claim 1 amendments. Examiner has similarly amended the rejection for claims 16 and 19.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached on (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866)217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800)786-9199 (IN USA OR CANADA) or (571)272-1000.
/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/
Primary Examiner, Art Unit 3686