DETAILED ACTION
The present office action represents a nonfinal action on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/5/2025 has been entered.
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 provisional application 62/910,232 of October 3, 2019, a continuation in part application of 17/021,895 of September 15, 2020, continuation of 17/150,938 of January 15, 2021, provisional application 63/191,511 of May 21, 2021, and continuation in part application 17/739,906 of May 9, 2022.
Status of Claims
Claims 1 and 20 are amended and claims 1-15 and 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 1-15 and 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 1-15 are drawn to a method for enabling patient pseudonymization or anonymization in telemedicine session subject to the consent of a third party, which is within the four statutory categories (i.e., process). Claim 20 is drawn to a system for enabling patient pseudonymization or anonymization in telemedicine session subject to the consent of a third party, which is within the four statutory categories (i.e., machine).
Claims 1-15 recite a method for protecting healthcare information associated with an individual, the method comprising, using one or more processing devices:
receiving, at the one or more processing devices, at least a first electronic medical record associated with the individual, wherein the first electronic medical record includes at least one healthcare service indicated by the individual;
generating, at the one or more processing devices, a patient identifier associated with the individual, wherein the patient identifier is associated with at least one of physiological information about the individual and medications being taken by the individual;
generating, at the one or more processing devices and using the patient identifier and at least a portion of the first electronic medical record, the at least a portion of the first electronic medical record including the at least one healthcare service, at least one protected electronic medical record corresponding to the first electronic medical record,
providing, from the one or more processing devices to at least a healthcare provider interface, at least one of the patient identifier and at least a portion of the at least one protected electronic medical record;
generating, at the one or more processing devices and based on the at least one of the patient identifier and the at least a portion of the at least one protected electronic medical record, a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service;
receiving, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan; and
controlling at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record.
Claim 20 recites system comprising:
one or more processing devices; and
a memory including instructions that, when executed by the one or more processing devices, cause the one or more processing devices to:
receive at least a first electronic medical record associated with an individual, wherein the first electronic medical record includes at least one healthcare service indicated by the individual;
generate a patient identifier associated with the individual, wherein the patient identifier is associated with at least one of physiological information about the individual and medications being taken by the individual;
generate, using the patient identifier and at least a portion of the first electronic medical record, the at least a portion of the first electronic medical record including the at least one healthcare service, at least one protected electronic medical record corresponding to the first electronic medical record,
provide, at least at a healthcare provider interface, at least one of the patient identifier and at least a portion of the at least one protected electronic medical record;
generate, based on the at least one of the patient identifier and the at least a portion of the at least one protected electronic medical record, a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service;
receive, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan; and
control at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components. 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.
Dependent claims 2-15 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. These limitations only serve to further limit the abstract idea (or contain the same additional elements found in the independent claim), and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 20.
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 and 20.
The additional elements from claims 1 and 20 include:
at least at a healthcare provider interface (apply it, MPEP 2106.05(f)).
one or more processing devices (apply it, MPEP 2106.05(f)).
a treatment apparatus (generally linking, MPEP 2106.05(h)).
a corresponding sensor (apply it, MPEP 2106.05(f)).
The additional elements from claim 20 include:
a system (apply it, MPEP 2106.05(f)).
a processing device (apply it, MPEP 2106.05(f)).
a memory including instructions that, when executed by the processor, cause the processor to (apply it, MPEP 2106.05(f)).
The dependent claims include the following additional elements beyond those recited in the independent claims:
one or more privacy enhancing technologies (apply it, MPEP 2106.05(f)).
during a telemedicine session (generally linking, MPEP 2106.05(h)).
These additional elements, in the independent claims 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 “a healthcare provider interface”, “privacy enhancing technologies”, “processing device”, “system”, “memory”, “a corresponding sensor”, and “processor”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g., see Specification Paragraphs [0047], 0052]-[0054], [0070], [0081], [0091]-[0094] (See MPEP 2106.05(f)).
generally link the abstract idea to a particular technological environment or field of use (e.g., during a telemedicine session ) (See MPEP 2106.05(h)).
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., the Specification Paragraphs [0047], 0052]-[0054], [0070], [0081] discloses that the additional elements (i.e., a healthcare provider interface, privacy enhancing technologies, processing device, system, memory, and processor) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare, enabling patient pseudonymization or anonymization in a telemedicine session);
Relevant court decisions: The following example of court decision demonstrating well understood, routine and conventional activities, e.g., see MPEP 2106.05(d)(II): Receiving medication use data, e.g., see Intellectual Ventures v. Symantec – similarly, the current invention receives patient electronic medical record.
Dependent claims 2-15 include other limitations, but none of these functions are deemed significantly more than the abstract idea. 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 any other technology, and their collective functions merely provide conventional computer implementation.
The application, is an attempt to organize human activity, using systems and methods for enabling patient pseudonymization or anonymization in a telemedicine session, which is not patentable. Therefore, whether taken individually or as an ordered combination, claims 1-15 and 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 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson (U.S. Pub. No. 2021/0240853 A1) in view of Malcolm (U.S. Pub. No. 2018/0256939 A1) and Mallon (U.S. Pub. No. 2012/0259649 A1).
Regarding claim 1, Carlson discloses a method for protecting healthcare information associated with an individual, the method comprising, using one or more processing devices (Paragraphs [0002]-[0003] and [0009] discuss de-identification or anonymization processing using a structured data processor, in which data that are usable to identify an individual may be scrubbed while other data may be maintained in some form to be used for various beneficial purposes.):
receiving, at the one or more processing devices, at least a first electronic medical record associated with the individual, wherein the first electronic medical record includes at least one healthcare service indicated by the individual (Paragraphs [0009], [0013], [0017], and [0045] discuss a structured data processor and receiving one or more data sets, that include medical records associated with one or more patients and processing the one or more data sets in accordance with a first de-identification policy to generate first de-identified data; structured data files may contain recorded physiological measurements, lab results, treatments applied, prescription, diagnoses, etc.);
generating, at the one or more processing devices, a patient identifier associated with the individual, wherein the patient identifier is associated with at least one of physiological information about the individual and medications being taken by the individual (Paragraphs [0007], [0009], [0015], [0045], and [0076] discuss wherein the de-identified data includes one or more de-identified data sets associated with one or more subjects that is generated from one or more raw data sets associated with the one or more subjects, each of the one or more raw data sets containing one or more data points associated with a respective subject of the one or more subjects, wherein the one or more data points include one or more identifying features that are usable to identify the respective subject and a structured data processor and receiving one or more data sets, that include medical records associated with one or more patients, identifiers may be used within hospital information systems to identify patients and universally unique identifier (UUID) is generated, the data extracted from EMRs include diagnoses, treatments, prescriptions, data from heartrate sensors, weight scales, glucose meters, etc.);
generating, at the one or more processing devices and using the patient identifier and at least a portion of the first electronic medical record, the at least a portion of the first electronic medical record including the at least one healthcare service, at least one protected electronic medical record corresponding to the first electronic medical record (Paragraphs [0009], [0045], [0152] discuss structured data processor and receiving one or more data sets, multiple types of data obtained from various sources may be linked together such that the same patient's data can be correlated between different streams. Suppose a patient named “John Smith” has an MRN and also has both DICOM and EMR data, the de-identification module may assign the same pseudo-identifiers (e.g., randomly-generated unique identifiers) and use the same time shift for both EMR and DICOM data. Thus, if this patient were assigned the pseudo-identifier MRN in an EMR pipeline, DICOM images for this patient may also be tagged with MRN, the data extracted from EMRs include diagnoses, treatments, prescriptions, data from heartrate sensors, weight scales, glucose meters, etc.);
providing, from the one or more processing devices to, at least a healthcare provider interface, at least one of the patient identifier and at least a portion of the at least one protected electronic medical record (Paragraphs [0009], [0144], [0149], [0152], and FIG. 5 discuss a structured data processor and user interface output devices include a display for creating a visible image and data captured and/or obtained in a secure environment—a hospital in FIG. 5—is de-identified using various techniques described herein so that it can be provided to a research entity, including EMR and multiple types of data obtained from the various sources may be linked together such that the same patient's data can be correlated between different streams.);
generating, at the one or more processing devices and based on the at least one of the patient identifier and the at least a portion of the at least one protected electronic medical record (Paragraphs [0007], [0009], [0045], and [0076] discuss a structured data processor and receiving one or more data sets, that include medical records associated with one or more patients, identifiers may be used within hospital information systems to identify patients and universally unique identifier (UUID) is generated, the data extracted from EMRs include diagnoses, treatments, prescriptions, data from heartrate sensors, weight scales, glucose meters, etc.).
Carlson does not explicitly disclose:
a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service;
receiving, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan; and
controlling at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record.
Malcolm teaches:
a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service (Paragraphs [0022]-[0026] discuss patient’s therapeutic options based on his treatment plan, tracking prescribed physical movements of the treatment plan while holding a tracking device or sensor, for example located on a weight or resistance band.);
receiving, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least data of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan (Paragraphs [0024], [0026] discuss a treatment plan and use of stretch or resistance bands with upper body or lower body movement, the sensor would be held either by the band itself or by the glove, strap or wrap, data generated daily will be transmitted to the therapist via the internet through a wireless internet connection, ensuring that the therapist is in constant contact with the patient.); and
controlling at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record (Paragraphs [0024]-[0026] discuss the therapist adding number of repetitions and weight increments or resistance to each prescribed movement in the treatment plan and the data generated daily will be transmitted to the therapist.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include, a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service, receiving, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least data of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan, and controlling at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record, as taught by Malcolm in order to provide a patient with an alternative method for measuring range of motion, creating therapeutic movements and or exercise routines, and the tracking of exercise and performance daily and track compliance of patients. (Malcolm Paragraphs [0007]-[0008] and [0010]).
Mallon teaches:
receiving, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan (Paragraphs [0060] discuss a movement monitoring system receive sensor data related to certain exercise according to a treatment plan can include biometric or physiologic function sensors such as heart rate, blood pressure, etc.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include, receiving, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan, as taught by Mallon in order to verify the activity and movement, and to assess performance of and optimization of the prescribed treatment. (Mallon Paragraph [0002]).
Regarding claim 20, Carlson discloses system comprising:
one or more processing devices (Paragraph [0018] discusses one or more processors of one or more computing devices, where the one or more processors are operable to execute instructions stored in associated memory.); and
a memory including instructions that, when executed by the one or more processing devices, cause the one or more processing devices to (Paragraph [0018] discusses one or more processors of one or more computing devices, where the one or more processors are operable to execute instructions stored in associated memory.):
receive at least a first electronic medical record associated with an individual, wherein the first electronic medical record includes at least one healthcare service indicated by the individual (Paragraphs [0009], [0013], [0017], and [0045] discuss a structured data processor and receiving one or more data sets, that include medical records associated with one or more patients and processing the one or more data sets in accordance with a first de-identification policy to generate first de-identified data; structured data files may contain recorded physiological measurements, lab results, treatments applied, prescription, diagnoses, etc.);
generate a patient identifier associated with the individual, wherein the patient identifier is associated with at least one of physiological information about the individual and medications being taken by the individual (Paragraphs [0007], [0009], [0015], [0045], and [0076] discuss wherein the de-identified data includes one or more de-identified data sets associated with one or more subjects that is generated from one or more raw data sets associated with the one or more subjects, each of the one or more raw data sets containing one or more data points associated with a respective subject of the one or more subjects, wherein the one or more data points include one or more identifying features that are usable to identify the respective subject and a structured data processor and receiving one or more data sets, that include medical records associated with one or more patients, identifiers may be used within hospital information systems to identify patients and universally unique identifier (UUID) is generated, the data extracted from EMRs include diagnoses, treatments, prescriptions, data from heartrate sensors, weight scales, glucose meters, etc.);
generate, using the patient identifier and at least a portion of the first electronic medical record, the at least a portion of the first electronic medical record including the at least one healthcare service, at least one protected electronic medical record corresponding to the first electronic medical record, (Paragraphs [0009], [0045], [0152] discuss structured data processor and receiving one or more data sets, multiple types of data obtained from various sources may be linked together such that the same patient's data can be correlated between different streams. Suppose a patient named “John Smith” has an MRN and also has both DICOM and EMR data, the de-identification module may assign the same pseudo-identifiers (e.g., randomly-generated unique identifiers) and use the same time shift for both EMR and DICOM data. Thus, if this patient were assigned the pseudo-identifier MRN in an EMR pipeline, DICOM images for this patient may also be tagged with MRN, the data extracted from EMRs include diagnoses, treatments, prescriptions, data from heartrate sensors, weight scales, glucose meters, etc.);
provide, at least at a healthcare provider interface, at least one of the patient identifier and at least a portion of the at least one protected electronic medical record (Paragraphs [0144], [0149], [0152], and FIG. 5 discuss a user interface output devices include a display for creating a visible image and data captured and/or obtained in a secure environment—a hospital in FIG. 5—is de-identified using various techniques described herein so that it can be provided to a research entity, including EMR and multiple types of data obtained from the various sources may be linked together such that the same patient's data can be correlated between different streams.);
generate, based on the at least one of the patient identifier and the at least a portion of the at least one protected electronic medical record (Paragraphs [0007], [0009], [0045], and [0076] discuss a structured data processor and receiving one or more data sets, that include medical records associated with one or more patients, identifiers may be used within hospital information systems to identify patients and universally unique identifier (UUID) is generated, the data extracted from EMRs include diagnoses, treatments, prescriptions, data from heartrate sensors, weight scales, glucose meters, etc.);
Carlson does not explicitly disclose:
a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service.
receive, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan; and
control at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record.
Malcolm teaches:
a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service (Paragraphs [0022]-[0026] discuss patient’s therapeutic options based on his treatment plan, tracking prescribed physical movements of the treatment plan while holding a tracking device or sensor, for example located on a weight or resistance band.);
receive, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least data of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan (Paragraphs [0024], [0026] discuss a treatment plan and use of stretch or resistance bands with upper body or lower body movement, the sensor would be held either by the band itself or by the glove, strap or wrap, data generated daily will be transmitted to the therapist via the internet through a wireless internet connection, ensuring that the therapist is in constant contact with the patient.); and
control at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record (Paragraphs [0024]-[0026] discuss the therapist adding number of repetitions and weight increments or resistance to each prescribed movement in the treatment plan and the data generated daily will be transmitted to the therapist.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include, a treatment plan to be performed by the individual using a treatment apparatus, the treatment plan corresponding to the at least one healthcare service, receive, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least data of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan, and control at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record, as taught by Malcolm in order to provide a patient with an alternative method for measuring range of motion, creating therapeutic movements and or exercise routines, and the tracking of exercise and performance daily and track compliance of patients. (Malcolm Paragraphs [0007]-[0008] and [0010]).
Mallon teaches:
receive, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan (Paragraphs [0060] discuss a movement monitoring system receive sensor data related to certain exercise according to a treatment plan can include biometric or physiologic function sensors such as heart rate, blood pressure, etc.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include, receive, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan, as taught by Mallon in order to verify the activity and movement, and to assess performance of and optimization of the prescribed treatment. (Mallon Paragraph [0002]).
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Malcolm and Mallon and in further view of Hsu (U.S. Pub. No. 2009/0037334 A1).
Regarding claim 2, Carlson discloses wherein at least a portion of the first electronic medical record and at least a portion of the first electronic medical record is further protected by one or more privacy enhancing technologies (Paragraphs [0017] and [0035] discuss the raw data sets associated with one or more patients include medical records and the centralized de-identification of protected data.).
Carlson does not explicitly disclose:
electronic medical record is in plaintext and at least a portion of the first electronic medical record in plaintext.
Hsu teaches:
electronic medical record is in plaintext and at least a portion of the first electronic medical record in plaintext (Paragraph [0038] and FIG. 3 discuss the data encrypting and decrypting unit will first determine whether the medical record data should be proceeded with an "encrypting process" or a "decrypting process" and the medical record data are converted from plaintext to ciphertext.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include electronic medical record is in plaintext and at least a portion of the first electronic medical record in plaintext, as taught by Hsu, in order assure the accuracy and the privacy of the medical record data (Hsu Paragraph [0003]).
Regarding claim 3, Carlson discloses wherein the at least one protected electronic medical record is associated with at least the portion of the first electronic medical record (Paragraphs [0149], [0152], FIG. 5 discuss multiple types of data obtained from the various sources may be linked together such that the same patient's data can be correlated between different streams, for example, a patient named “John Smith” has an MRN and also has both DICOM and EMR data, de-identification module may assign the same pseudo-identifiers (e.g., randomly-generated unique identifiers) and use the same time shift for both EMR and DICOM data.).
Carlson does not explicitly disclose:
electronic medical record in plaintext.
Hsu teaches:
electronic medical record in plaintext (Paragraph [0038] and FIG. 3 discuss the data encrypting and decrypting unit will first determine whether the medical record data should be proceeded with an "encrypting process" or a "decrypting process" and the medical record data are converted from plaintext to ciphertext.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include electronic medical record in plaintext, as taught by Hsu, in order assure the accuracy and the privacy of the medical record data (Hsu Paragraph [0003]).
Regarding claim 4, Carlson discloses wherein the at least one protected electronic medical record is configured to be used in place of at least the portion of the first electronic medical record (Paragraphs [0013], [0017], [0034], [0151], and FIG. 1 discuss receiving one or more data sets, that include medical records associated with one or more patients and the output of de-identification module takes the form of de-identified data and the de-identified data may be used for various beneficial purposes, such as disease research, development of drugs and other treatments, etc.).
Carlson does not explicitly disclose:
electronic medical record in plaintext.
Hsu teaches:
electronic medical record in plaintext (Paragraph [0038] and FIG. 3 discuss the data encrypting and decrypting unit will first determine whether the medical record data should be proceeded with an "encrypting process" or a "decrypting process" and the medical record data are converted from plaintext to ciphertext.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include electronic medical record in plaintext, as taught by Hsu, in order assure the accuracy and the privacy of the medical record data (Hsu Paragraph [0003]).
Regarding claim 5, Carlson discloses wherein the one or more privacy enhancing technologies are configured to support aspects of at least one of health insurance portability and accountability act requirements, Gramm-Leach-Bliley act requirements, and general data protection regulation requirements (Paragraphs [0157] and [0159]-[0163] discuss de-identification to support multiple user classes, e.g., to avoid repeated data extraction and processing as described above in the United States, HIPAA regulations allow for either “Safe Harbor” de-identification or “Expert Determination” de-identification and a specific use case (e.g., a specific study, research, etc.), data is de-identified as aggressively as possible to allow that particular use case to be beneficial while still satisfying applicable regulations or agreements.).
Claim 6 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Malcolm and Mallon and in further view of Peterson (U.S. Pub. No. 2019/0005195 A1).
Regarding claim 6, Carlson discloses further comprising providing, at least at the healthcare provider interface, the at least one of the patient identifier and at least the portion of the at least one protected electronic medical record (Paragraphs [0144], [0149], [0152], and FIG. 5 discuss a user interface output devices include a display for creating a visible image and data captured and/or obtained in a secure environment—a hospital in FIG. 5—is de-identified using various techniques described herein so that it can be provided for example, to a research entity, including EMR and multiple types of data obtained from the various sources may be linked together such that the same patient's data can be correlated between different streams.).
Carlson does not explicitly disclose:
during a telemedicine session.
Peterson teaches:
during a telemedicine session (Paragraphs [0054] discuss telemedicine access to care.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include during a telemedicine session, as taught by Peterson, in order improve patient modeling and care (Peterson Paragraph [0001]).
Claims 7-14 are rejected under 35 U.S.C. 103 as being unpatentable Carlson in view of Malcolm and Mallon and in further view of Raduchel (U.S. Pub. No. 2015/0046192 A1).
Regarding claim 7, Carlson does not explicitly disclose further comprising identifying, based on the at least one healthcare service indicated by the individual, a healthcare provider associated with providing the at least one healthcare service.
Raduchel teaches:
further comprising identifying, based on the at least one healthcare service indicated by the individual, a healthcare provider associated with providing the at least one healthcare service (Paragraph [0083] discusses the system accesses only certain types of electronic medical records based on the request, for example, an orthopedic doctor only may be able to access records associated with orthopedic treatment and prevented from accessing other types of medical records that may be irrelevant to orthopedic treatment, such as, for example, hair loss or skin rash.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include further comprising identifying, based on the at least one healthcare service indicated by the individual, a healthcare provider associated with providing the at least one healthcare service, as taught by Raduchel, in order improve treatment or diagnosis by allowing complete review of medical records in a timely manner (Raduchel Paragraph [0055]).
Regarding claim 8, Carlson does not explicitly disclose wherein the at least one healthcare service includes at least one of erectile dysfunction, sexual transmitted disease test results or diagnoses, hemorrhoids, ulcerative colitis, irritable bowel syndrome or disorder, Crohn's disease, diseases or conditions related to the genitourinary systems of males, female or other genders, gender reassignment surgery or medications and hormones prescribed and associated therewith, neurodegenerative diseases, and cancer diagnoses, treatments or conditions.
Raduchel teaches:
disclose wherein the at least one healthcare service includes at least one of erectile dysfunction (Paragraph [0083] discusses the system accesses only certain types of electronic medical records based on the request, for example, information on particular conditions (e.g., herpes, HIV, erectile dysfunction, unexpected pregnancy, miscarriage) may require special access authorization.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include disclose wherein the at least one healthcare service includes at least one of erectile dysfunction, as taught by Raduchel, in order improve treatment or diagnosis by allowing complete review of medical records in a timely manner (Raduchel Paragraph [0055]).
Regarding claim 9, Carlson does not explicitly disclose wherein the at least one healthcare service includes one or more orthopedic conditions.
Raduchel teaches:
wherein the at least one healthcare service includes one or more orthopedic conditions (Paragraph [0083] discusses the system accesses only certain types of electronic medical records based on the request, for example, an orthopedic doctor only may be able to access records associated with orthopedic treatment and prevented from accessing other types of medical records that may be irrelevant to orthopedic treatment, such as, for example, hair loss or skin rash.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include wherein the at least one healthcare service includes one or more orthopedic conditions, as taught by Raduchel, in order improve treatment or diagnosis by allowing complete review of medical records in a timely manner (Raduchel Paragraph [0055]).
Regarding claim 10, Carlson does not explicitly disclose further comprising identifying, based on at least one of the at least one healthcare service and the identified healthcare provider, relevant information of the first electronic medical record.
Raduchel teaches:
further comprising identifying, based on at least one of the at least one healthcare service and the identified healthcare provider, relevant information of the first electronic medical record (Paragraph [0083] discusses the system accesses only certain types of electronic medical records based on the request, for example, an orthopedic doctor only may be able to access records associated with orthopedic treatment and prevented from accessing other types of medical records that may be irrelevant to orthopedic treatment, such as, for example, hair loss or skin rash.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include further comprising identifying, based on at least one of the at least one healthcare service and the identified healthcare provider, relevant information of the first electronic medical record, as taught by Raduchel, in order improve treatment or diagnosis by allowing complete review of medical records in a timely manner (Raduchel Paragraph [0055]).
Regarding claim 11, Carlson discloses wherein the relevant information corresponds to the at least the portion of the first electronic medical record used to generate the at least one protected electronic medical record (Paragraphs [0013], [0017], [0034], [0151], and FIG. 1 discuss receiving one or more data sets, that include medical records associated with one or more patients and the output of de-identification module takes the form of de-identified data and the de-identified data may be used for various beneficial purposes, such as disease research, development of drugs and other treatments, etc.).
Regarding claim 12, Carlson does not explicitly disclose further comprising receiving input, from the individual, indicating a selected portion of the first electronic medical record.
Raduchel teaches:
further comprising receiving input, from the individual, indicating a selected portion of the first electronic medical record (Paragraphs [0073] and [0083] discuss receive user input requesting records and the system accesses only certain types of electronic medical records based on the request, for example, an orthopedic doctor only may be able to access records associated with orthopedic treatment and prevented from accessing other types of medical records that may be irrelevant to orthopedic treatment, such as, for example, hair loss or skin rash.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include further comprising receiving input, from the individual, indicating a selected portion of the first electronic medical record, as taught by Raduchel, in order improve treatment or diagnosis by allowing complete review of medical records in a timely manner (Raduchel Paragraph [0055]).
Regarding claim 13, Carlson does not explicitly disclose further comprising generating, using the input indicating the selected portion of the electronic medical record, at least one other protected electronic medical record.
Raduchel teaches:
further comprising generating, using the input indicating the selected portion of the electronic medical record, at least one other protected electronic medical record (Paragraphs [0073], [0077], and [0083] discuss receive user input requesting records and the system accesses only certain types of electronic medical records based on the request, and generates a request for the medical records based on the accessed information and authentication token, for example, an orthopedic doctor only may be able to access records associated with orthopedic treatment and prevented from accessing other types of medical records that may be irrelevant to orthopedic treatment, such as, for example, hair loss or skin rash.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include further comprising generating, using the input indicating the selected portion of the electronic medical record, at least one other protected electronic medical record, as taught by Raduchel, in order improve treatment or diagnosis by allowing complete review of medical records in a timely manner (Raduchel Paragraph [0055]).
Regarding claim 14, Carlson does not explicitly disclose further comprising providing, at least at the healthcare provider interface, at least a portion of the at least one other protected electronic medical record.
Raduchel teaches:
further comprising providing, at least at the healthcare provider interface, at least a portion of the at least one other protected electronic medical record (Paragraphs [0013], [0077], [0083] discuss display to the medical service provider information related to the specific electronic medical records that the medical service provider is authorized to view.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include further comprising providing, at least at the healthcare provider interface, at least a portion of the at least one other protected electronic medical record, as taught by Raduchel, in order improve treatment or diagnosis by allowing complete review of medical records in a timely manner (Raduchel Paragraph [0055]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Malcolm and Mallon and in further view of Raduchel and Peterson.
Regarding claim 15, Carlson discloses further comprising providing, at least at the healthcare provider interface, at least a portion of the at least one other protected electronic medical record (Paragraphs [0144], [0149], [0152], and FIG. 5 discuss a user interface output devices include a display for creating a visible image and data captured and/or obtained in a secure environment—a hospital in FIG. 5—is de-identified using various techniques described herein so that it can be provided for example, to a research entity, including EMR and multiple types of data obtained from the various sources may be linked together such that the same patient's data can be correlated between different streams.).
Carlson does not explicitly disclose:
during a telemedicine session.
Peterson teaches:
during a telemedicine session (Paragraphs [0054] discuss telemedicine access to care.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Carlson to include during a telemedicine session, as taught by Peterson, in order improve patient modeling and care (Peterson Paragraph [0001]).
Response to Arguments
Applicant’s arguments filed 11/05/2025 have been fully considered.
Rejections under 35 U.S.C. 101:
With respect to claim 1 and the Prong 1 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, “Applicant's claims at most merely involve an exception and can only be alleged to recite an abstract idea when considered at too high a level of abstraction; therefore, Applicant's claims are in fact not directed to a judicial exception. For example, amended claim 1 recites, inter alia: "receiving, while the individual uses the treatment apparatus to perform the treatment plan, sensor data, wherein the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual uses the treatment apparatus to perform the treatment plan; and controlling at least one characteristic of the treatment apparatus based on the sensor data and the at least one protected electronic medical record."” (Remarks, page 8). Applicant further states, “the limitations of claim 1, at least as amended, include structural elements that perform functions that are not capable of being performed by a human. These functions are not instructions that are simply relayed to a human and then performed by a human. As such, the systems and method are not and cannot be implemented merely by the actions of the user.” (Remarks, page 9). Examiner respectfully disagrees. Here, the improvement is the abstract idea. Applicant’s claims are managing personal behavior or relationships or interactions between people because the claims are directed to protecting healthcare information associated with an individual – enabling patient pseudonymization or anonymization in a telemedicine session subject to the consent of a third party. The additional elements are recited at the apply it level and are merely used as tools to implement the abstract idea. Protecting private healthcare information associated with the patient and/or allowing the patient to remain anonymous or pseudonymous while seeking and/or engaging with healthcare services, is not a technical problem rooted in the technology and is directed to the abstract idea. As indicated above, the additional elements recited in the claims are recited at the apply it level, and are merely used as tools to implement the abstract idea. As such, the additional elements are not improved by the claimed invention.
Practical application is a way to overcome the Prong 2 35 U.S.C 101 rejection, however, here, as written, the claims do not result in a practical application. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicate that a practical application may be present where the claimed invention provides a technical solution to a technical problem. Applicant states, “he recited limitations, when reviewed as a whole, integrate the alleged judicial exception into a practical application. Specifically, the claims recite specific improvements to a method or system for protecting healthcare information by performing various steps using one or more processing devices to provide a patient identifier and a protected electronic medical record, generate a treatment plan, receive sensor data corresponding to the individual using a treatment device to perform the treatment plan, and control the treatment device using the sensor data and the protected electronic medical record, accordingly.” (Remarks, page 10). Applicant also states, “Applicant's claims recite additional elements beyond any judicial exception that, at least in combination, integrate the alleged exception into a practical application because the additional elements reflect, for example, "an improvement in the functioning of a computer, or an improvement to another technology or technical field." See MPEP § 2106.04(d)(I). For example, the claims provide specific improvements over prior systems and recite additional elements that "apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. Id. Thus, even where Applicant's claims allegedly recite a judicial exception, these claims clearly are not directed to the judicial exception and instead are directed to eligible subject matter.” (Remarks, pages 10-11). Examiner respectfully disagrees. The Application, protecting private healthcare information associated with the patient and/or allowing the patient to remain anonymous or pseudonymous while seeking and/or engaging with healthcare services, is part of the abstract idea and the abstract idea cannot be used to integrate itself into a practical application and therefore, is not an additional element. Here, the improvement is to the abstract idea and not the technology. Here, the additional elements, including an interface, one or more processing devices, a system, a processing device, a memory, do not result in a practical application or technical improvement, as they are recited at an apply it level, as stated above. Applicant’s claimed invention does not provide for an improvement to the functioning of a processing device, interface, system, memory, treatment apparatus, or any other technical field. Here, “receiving while the individual uses the treatment apparatus to perform the treatment plan, sensor data, where the sensor data includes at least one vital sign of the individual user measured by a corresponding sensor while the individual used the treatment apparatus”, is not an improvement to the function of the treatment apparatus or any other technology. Here the claims related to protecting private healthcare associated with the patient and/or allowing the patient to remail anonymous or pseudonymous while seeking and/or engaging with healthcare service, which is considered part of the abstract idea, and therefore results in an improvement to the abstract idea rather than a practical application.
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. Individually and in combination, the additional elements do not provide significantly more than the abstract idea. The claims recite features that are "well-understood, routine, conventional activities”. There is no technological improvement to any additional element. For the reasons stated above, claim 20 similarly fails to overcome the 35 U.S.C. 101 rejection.
Rejections under 35 U.S.C. 103:
Applicant’s amendments overcome the previous rejection. Applicant’s arguments are well taken. Examiner withdraws the previous rejection in light of the amendments. Applicant’s arguments with respect to claims 1 and 20 have been considered and the Examiner’s rejection has been updated to address Applicant’s claim 1 and 20 amendments.
Conclusion
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.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686