DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is a non-final rejection
Claims 1-23 are pending
Claims 1-9 were withdrawn
Claims 10-23 are rejected under 35 USC § 101
Claims 10-23 are rejected under 35 USC § 103
Election/Restrictions
Applicant's election with traverse of invention 2, with claims 10-23, in the reply filed on 4-9-2025 is acknowledged. The traversal is on the ground(s) that that the Examiner has failed to establish that a search of the complete application would be an undue burden as required by MPEP 803.
This is not found persuasive because the application contains the following inventions or groups of inventions which are not so linked as a to form a single general inventive concept under PCT Rule 13.1. Group I, claims 1-9, are drawn to a method to manage exposure of confidential user information, classified under G06F21/6254 and group II, claims 10-23, are drawn to method, system and medium for establishing a group for research by identifying and grouping patients by selecting criteria, classified un G06H10/60. Furthermore, the Examiner finds that it would be a burden to search the complete application under these conditions.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 5-25-2020
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12-20-2022, 4-5-2023, 8-17-2023, 8-6-2024, 4-9-2025, and 9-11-2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 10-23 are not patent eligible because the claimed invention is directed to an abstract idea without significantly more.
Analysis
First, claims are directed to one or more of the following statutory categories: a process, a machine, a manufacture, and a composition of matter. Regarding claims 10-23 the claims recite an abstract idea of “managing exposure of confidential user information in a user data record to a third party”.
Independent Claims 10, 22 and 23 are rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): Claims 10, 22 and 23 recite a method, a system and a non-transitory computer readable media of “managing exposure of confidential user information in a user data record to a third party“.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
establishing a cohort to conduct research;
health records about patients; and –
information indicative of (i) consent of respective ones of the patients that respective ones of the health records about the respective ones of the patients be accessible for the research and (ii) parameters regarding the consent of the respective ones of the patients;
receiving, ..., a request from a third party related to the research and indicative of at least one criterion for the research;
identifying, .., individual ones of the health records about individual ones of the patients that meet the at least one criterion for the research and that correspond to the parameters regarding the consent of the individual ones of the patients;–
transmitting, ... data included in the individual ones of the health records to the third party for conducting the research.
belonging to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “managing exposure of confidential user information in a user data record to a third party”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “managing exposure of confidential user information in a user data record to a third party”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO).
Claims 10, 22, 23 recite:
storing health records about patients in computer-readable memory;
receiving, , identifying and transmitting with at least one processor;
synaptic circuits, each of the synaptic circuits including a memory for storing a synaptic weight, wherein each of the neurons is connected to at least one other of the neurons via at least one of the synaptic circuits, the processing elements of the neurons configured to;
Claim 10 recites:
A computer-implemented method of establishing a cohort to conduct research
Claim 22 recites:
system comprising at least one processor and computer-readable memory of establishing a cohort to conduct research
Claim 23 recites:
Non-transitory computer-readable storage media comprising instructions executable by at least one processor of a computing entity for establishing a cohort to conduct research.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two:
Claims 10, 22, 23 recite:
storing health records about patients in computer-readable memory;
receiving, , identifying and transmitting with at least one processor;
synaptic circuits, each of the synaptic circuits including a memory for storing a synaptic weight, wherein each of the neurons is connected to at least one other of the neurons via at least one of the synaptic circuits, the processing elements of the neurons configured to;
Claim 10 recites:
A computer-implemented method of establishing a cohort to conduct research
Claim 22 recites:
system comprising at least one processor and computer-readable memory of establishing a cohort to conduct research
Claim 23 recites:
Non-transitory computer-readable storage media comprising instructions executable by at least one processor of a computing entity for establishing a cohort to conduct research.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Dependent Claims:
Step 2A Prong One: The following dependent claims recites additional limitations that further define the abstract idea of “managing exposure of confidential user information in a user data record to a third party”. The claim limitations include:
Claim 11: wherein the parameters regarding the consent of the respective ones of the patients include a period of validity of the consent of the respective ones of the patients.
Claims 12: wherein the parameters regarding the consent of the respective ones of the patients include a definition of information included in the respective ones of the health records that the respective ones of the patients consent to making accessible.
Claim 13: wherein the parameters regarding the consent of the respective ones of the patients include a type of research project for which the respective ones of the patients consent to making the respective ones of the health records accessible.
Claim 14: comprising anonymizing, .. the data included in the individual ones of the health records such that the data included in the individual ones of the health records is anonymized before the transmitting.
Claim 15: wherein the at least one criterion for the research includes at least one of a disorder, an infection, a disability, and an injury.
Claim 16: wherein the at least one criterion for the research includes a medical test.
Claim 17: wherein the at least one criterion for the research includes a willingness to physically participate in the research.
Claim 18: comprising recording ... information indicative of transmission of the data included in the individual ones of the health records to the third party for traceability.
Claim 19: comprising, in response to the research identifying an anomalous condition in the data included in a given health record of the individual ones of the health records that is about a given patient of the individual ones of the patients, notifying the given patient of the anomalous condition.
Claim 20: wherein the third party is a pharmaceutical company.
Claim 21: wherein the third party is a biomedical company.
Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). The following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims include:
Claim 14: anonymizing, with the at least one processor, the data.
Claim 18: recording in the computer-readable memory information.
Step 2B (Does the additional elements of the claim provide an inventive concept?: NO). As discussed previously with respect to Step 2A Prong Two, the following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible. The claims include:
Claim 14: anonymizing, with the at least one processor, the data.
Claim 18: recording in the computer-readable memory information.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
non-obviousness.
Claims 10, 13, 15-17, 22-23 are rejected under 35 U.S.C. 103 as being un-patentable by Willard et.al. (US 20160357916 A1) hereinafter “Willard” in view of Shelton et.al (US 20140289001 A1) hereinafter “Shelton”.
Regarding claims 10, 22, 23 Willard teaches:
Storing: (See at least [0008] via: “...An electronic medical record system includes a first electronic medical record system to store a complete medical record for a patient...”)
health records about patients; (See at least [0004] via: “...The computerized system and method comprises an electronic medical record (EMR) appliance or apparatus that facilitates the exchange of information between electronic medical record systems that store complete medical records for patients..”) and –
information indicative of (i) consent of respective ones of the patients that respective ones of the health records about the respective ones of the patients be accessible [for the research] and (ii) parameters regarding the consent of the respective ones of the patients; (See at least [0005] via: “...The EMR appliance includes a medical information exchange consent policy module that further includes instructions executed by a processor to supply to a patient with a medical information exchange consent policy interface with selectable medical information exchange consent policy elements. The EMR appliance receives selected medical information exchange consent policy elements from the user,..”)
receiving, with at least one processor, a request from a third party [related to the research and indicative of at least one criterion for the research]; (See at least [0005] via: “.. accepts from an electronic medical record system a medical record request for the patient,..”).-
identifying, with the at least one processor, individual ones of the health records about individual ones of the patients [that meet the at least one criterion for the research and] that correspond to the parameters regarding the consent of the individual ones of the patients; (See at least [0005] via: “..filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record ..”) and
transmitting, with the at least one processor, data included in the individual ones of the health records to the third party [for conducting the research]. (See at least [0005] via: “.. transfers the consent-filtered medical record to the electronic medical record system..”; in addition see at least [0007] via: “..Multiple EMR appliances may be connected to create networks and to distribute consent policy management to local healthcare provider offices. The distribution and customization of policies at the local level enforces consent at the edges and removes the need for a single, global consent policy within a large healthcare system. Consent policies may be defined within a practice with specific rules about which criteria to use in searching a health record and then additionally, which portions of the health record should be redacted (if any). This result is accomplished with a point and click interface..”)
However, Willard is silent teaching the following limitation that are taught by Shelton:
establishing a cohort to conduct research; (See at least [0035] via: “...a system and method for locating persons who are likely to have an interest in being considered for participation in clinical research studies, and who would be motivated to embrace privacy preferences that will enable the use and disclosure of their confidential personal information for such purposes...”; in addition see at least [0037] via: “.. Such a system and method may provide for a properly authenticated researcher, or a person or agency acting on his or her behalf, to identify, compare, and be authorized to contact individuals who are suited to being subjects in clinical trials and research studies..”)
health records of the patients accessible for research (See at least [0035] via: “...a system and method for locating persons who are likely to have an interest in being considered for participation in clinical research studies, and who would be motivated to embrace privacy preferences that will enable the use and disclosure of their confidential personal information for such purposes...”; in addition see at least [0055] via: “.. In an illustrative embodiment, a searcher can request medical images for a patient whose medical record may have a variety of different medical images, such as dental X-rays, bone X-rays, gastro-intestinal ultrasound images, PET scans, and MRI scans. The patient may have designated certain records, for example, all of the X-rays and ultrasound images, as having a `medium` distribution privilege level, and other records such as the PET and MRI scans as having a `high` distribution privilege level. If the searcher authentication protocol has determined that the searcher has a particular privilege level, then the records within that privilege level can be provided to the searcher. In the illustrative embodiment, certain non-viewable search results are listed in the search result window, but they may display identifying tags that indicate that the searcher does not have privilege to access these particular records..”)
request related to the research and indicative of at least one criterion for the research (See at least [0035] via: “...a system and method for locating persons who are likely to have an interest in being considered for participation in clinical research studies, and who would be motivated to embrace privacy preferences that will enable the use and disclosure of their confidential personal information for such purposes...”; in addition see at least [0092] via: “...The availability of relevant clinical trials and research studies focusing on the condition or aspects of the typical phenotypic presentation of the condition that affects the group's members may be one such instance. Thus, one aspect of an illustrative embodiment of the invention is to empower such affinity groups to inform their members, contributors and readers about the clinical trials that are available to them and that might help to advance the science, diagnosis, treatment and/or short or long-term prognosis associated with the condition that such persons by definition share in common...”; in addition see at least [0053] via: “...the searcher is allowed to search a private records database 106 via a search algorithm 104. The searcher inputs desired search criteria to the search algorithm which communicates with the private records database 106 to recover search results 108 that meet the search criteria. This allows a searcher to search a private database such as a medical records database for a specific patient, primary care physician, or individual or entity that holds a desired medical record, for example...”; in addition see at least [0055] via: “.. In an illustrative embodiment, a searcher can request medical images for a patient whose medical record may have a variety of different medical images, such as dental X-rays, bone X-rays, gastro-intestinal ultrasound images, PET scans, and MRI scans. The patient may have designated certain records, for example, all of the X-rays and ultrasound images, as having a `medium` distribution privilege level, and other records such as the PET and MRI scans as having a `high` distribution privilege level. If the searcher authentication protocol has determined that the searcher has a particular privilege level, then the records within that privilege level can be provided to the searcher. In the illustrative embodiment, certain non-viewable search results are listed in the search result window, but they may display identifying tags that indicate that the searcher does not have privilege to access these particular records..”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard with Shelton. Willard teaches managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted. However, Willard fails to disclose a recruitment interface in order to allow conductors of research studies to access private records and locate appropriate research subjects interested in participating in clinical research studies as taught by Shelton. Combining Willard and Shelton is helpful in providing clinical research studies to patients who are interested in participating but are willing to provide only consent-filtered medical records to the professionals conducting the clinical research.
Regarding claim 13: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. Willard is silent the following claim that is taught by Shelton:
wherein the parameters regarding the consent of the respective ones of the patients include a type of research project for which the respective ones of the patients consent to making the respective ones of the health records accessible. (See at least [0035] via: “...a system and method for locating persons who are likely to have an interest in being considered for participation in clinical research studies, and who would be motivated to embrace privacy preferences that will enable the use and disclosure of their confidential personal information for such purposes...”; in addition see at least [0037] via: “..provide for a properly authenticated researcher, or a person or agency acting on his or her behalf, to identify, compare, and be authorized to contact individuals who are suited to being subjects in clinical trials and research studies..”; in addition see at least [0055] via: “.. In an illustrative embodiment, a searcher can request medical images for a patient whose medical record may have a variety of different medical images, such as dental X-rays, bone X-rays, gastro-intestinal ultrasound images, PET scans, and MRI scans. The patient may have designated certain records, for example, all of the X-rays and ultrasound images, as having a `medium` distribution privilege level, and other records such as the PET and MRI scans as having a `high` distribution privilege level. If the searcher authentication protocol has determined that the searcher has a particular privilege level, then the records within that privilege level can be provided to the searcher. In the illustrative embodiment, certain non-viewable search results are listed in the search result window, but they may display identifying tags that indicate that the searcher does not have privilege to access these particular records..”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard with Shelton. Willard teaches managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted. However, Willard fails to disclose a recruitment interface in order to allow conductors of research studies to access private records and locate appropriate research subjects interested in participating in clinical research studies as taught by Shelton. Combining Willard and Shelton is helpful in providing clinical research studies to patients who are interested in participating but are willing to provide only consent-filtered medical records to the professionals conducting the clinical research.
Regarding claim 15: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. Willard is silent the following claim that is taught by Shelton:
wherein the at least one criterion for the research includes at least one of a disorder, an infection, a disability, and an injury.
(See at least [0035] via: “...a system and method for locating persons who are likely to have an interest in being considered for participation in clinical research studies, and who would be motivated to embrace privacy preferences that will enable the use and disclosure of their confidential personal information for such purposes...”; in addition see at least [0037] via: “..provide for a properly authenticated researcher, or a person or agency acting on his or her behalf, to identify, compare, and be authorized to contact individuals who are suited to being subjects in clinical trials and research studies..”; in addition see at least [0076] via: “.. facilitate one or more disease advocacy groups, affinity groups and social networks ... to get word out to their members regarding the clinical trials and research studies that pertain to the disease, disorder or condition that affects the members of that group or network, and/or that are most likely to be of interest to such persons...”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard with Shelton. Willard teaches managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted. However, Willard fails to disclose a recruitment interface in order to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies as taught by Shelton. Combining Willard and Shelton is helpful in providing clinical research studies to patients who are interested in participating in clinical trials pertaining to their particular disease or disorder “that might help to advance the science, diagnosis, treatment and/or short or long-term prognosis associated with the condition that such persons by definition share in common” [Shelton 0092] while at the same time are willing to provide only consent-filtered medical records to the professionals conducting the clinical research
Regarding claim 16: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. Willard is silent the following claim that is taught by Shelton:
wherein the at least one criterion for the research includes a medical test. (See at least [0092] via: “...The availability of relevant clinical trials and research studies focusing on the condition or aspects of the typical phenotypic presentation of the condition that affects the group's members may be one such instance. Thus, one aspect of an illustrative embodiment of the invention is to empower such affinity groups to inform their members, contributors and readers about the clinical trials that are available to them and that might help to advance the science, diagnosis, treatment and/or short or long-term prognosis associated with the condition that such persons by definition share in common...”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard with Shelton. Willard teaches managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted. However, Willard fails to disclose a recruitment interface in order to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies as taught by Shelton. Combining Willard and Shelton is helpful in providing clinical research studies to patients who are interested in participating in clinical trials pertaining to their particular disease or disorder “that might help to advance the science, diagnosis, treatment and/or short or long-term prognosis associated with the condition that such persons by definition share in common” [Shelton 0092] while at the same time are willing to provide only consent-filtered medical records to the professionals conducting the clinical research.
Regarding claim 17: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. Willard is silent the following claim that is taught by Shelton:
wherein the at least one criterion for the research includes a willingness to physically participate in the research. (See at least [0118] via: “...Arrow 852 of FIG. 8 also illustrates that for any records subjects whose privacy considerations represented by rectangular box 833 indicate that the prior consent of such records subject is required before the contact information may be communicated to the research investigator, a notice of such selection would be sent via workstation 709(a) or printed on printer 707 and conveyed by facsimile, mail or other stipulated means to the prospective subject. Upon receipt of confirmation that such records subject wishes to take part in such research study or clinical trial, and thereby consents to his or her contact information being provided, that personal information will be communicated to the research investigator or CRO ...”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard with Shelton. Willard teaches managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted. However, Willard fails to disclose a recruitment interface in order to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies as taught by Shelton. Combining Willard and Shelton is helpful in providing clinical research studies to patients who are interested in participating in clinical trials pertaining to their particular disease or disorder “that might help to advance the science, diagnosis, treatment and/or short or long-term prognosis associated with the condition that such persons by definition share in common” [Shelton 0092] while at the same time are willing to provide only consent-filtered medical records to the professionals conducting the clinical research
Claims 11-12, 14, 20-21 are rejected under 35 U.S.C. 103 as being un-patentable by Willard in view of Shelton, in further view of Kenedy et.al (US 20100063843 A1) hereinafter “Kenedy”
Regarding claim 11: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. However Willard and Shelton are silent the following claim that is taught by Kenedy:
wherein the parameters regarding the consent of the respective ones of the patients include a period of validity of the consent of the respective ones of the patients. (See at least [0093] via: “..As further illustrated in FIG. 15, the user class interacts with the authorization class to control access, reading and transmission of consumer associated data ... through application of data masks to the data. ... a duration attribute which can specify the amount of time granted for accessing the data and/or can specify the length of time permissible for a user time-out, after which the system can execute an automated logout of the user from the system; and a number of reads attribute which indicates the number of times the data can be accessed during a each user session, or the number of times a particular portion of the data can be transmitted to a particular destination during each user session. Various operations can be associated with the authorization class and, as illustrated, an allow mask access operation can enable the user to access a mask for analysis, modification or deletion; an apply mask operation which enables a user to modify an existing mask; and a transmit masked data operation which enables the transmission of masked data to a destination such as an interface, workstation or server that is operated or accessed by a service provider or insurer...”; in addition see at least [0092] via: “.. As further illustrated in FIG. 15, the user class can interact with the mask class to create and modify various types of data masks. The user can, for example, initiate the creation of masks having attributes which, as illustrated, can include ... the expiration time/date of the mask..”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard and Shelton with Kenedy. Willard and Shelton teach managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted in addition to recruitment of patients to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies. However, Willard and Shelton fail to disclose a duration attribute which can specify the amount of time granted for accessing data as taught by Kenedy. Combining Willard, Shelton and Kenedy is helpful for patients who may be interested in participating in clinical trials pertaining to their particular disease or disorder only within a given window of time,
Regarding claim 12: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. However Willard and Shelton are silent the following claim that is taught by Kenedy:
wherein the parameters regarding the consent of the respective ones of the patients include a definition of information included in the respective ones of the health records that the respective ones of the patients consent to making accessible. (See at least [0092] via: “..illustrated in FIG. 15, the user class can interact with the mask class to create and modify various types of data masks. The user can, for example, initiate the creation of masks having attributes which, as illustrated, can include ...; the mask type (e.g., general mask types such as genetic, genetic coding, genetic regulatory, epigenetic, non-pangenetic, demographic, or more specific mask types such as those corresponding to and identified by gene name or corresponding trait/condition, for example); ... the known association regions (i.e., those portions/regions of the masked data that are known to associate with particular physical traits, behaviors, health conditions and/or predispositions); general confidential regions which indicate data that are to be kept private (masked) from others; and insurance confidential regions which indicate data that are to be masked specifically with respect to access and reading of the data by an insurer or in instances of transmission of the data for insurance or payment approval purposes. Various operations can be associated with the mask and, as illustrated, can include an apply operation in which a mask is applied to a set of data; an update operation in which a mask is updated based on user or system supplied information; a delete operation in which a user can implement deletion of a mask or the system can perform automated deletion of a mask that has reached its expiration date; and a create consensus operation in which a consensus data mask can be generated from two or more masks as disclosed previously and then applied to targeted data in accordance with the apply operation...”; in addition see at least [0093] via: “.. As further illustrated in FIG. 15, the user class interacts with the authorization class to control access, reading and transmission of consumer associated data (i.e., pangenetic and non-pangenetic data) through application of data masks to the data. The authorization class includes a type attribute which can indicate whether a particular authorization relates to access to pangenetic or non-pangenetic data types..”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard and Shelton with Kenedy. Willard and Shelton teach managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted in addition to recruitment of patients to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies. However, Willard and Shelton fail to disclose a type attribute which can indicate whether a particular authorization relates to access to a specific data types as taught by Kenedy. Combining Willard, Shelton and Kenedy is helpful for patients who may be interested in participating in clinical trials pertaining only and specifically to their particular disease or disorder.
Regarding claim 14: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. However Willard and Shelton are silent the following claim that is taught by Kenedy:
comprising anonymizing, with the at least one processor, the data included in the individual ones of the health records such that the data included in the individual ones of the health records is anonymized before the transmitting. (See at least [claim 26] via: “.. A computer based method for providing access to consumer controlled pangenetic information, comprising: a) receiving a request for a pangenetic record associated with a consumer; b) receiving authorization from the consumer for transmission of a masked pangenetic record; c) accessing a previously approved data mask, wherein the previously approved data mask corresponds to record positions which convey pangenetic features associated with one or more health conditions; d) applying the previously approved data mask to the pangenetic record associated with the consumer to generate a masked pangenetic record; and e) transmitting the masked pangenetic record....”; in addition see at least [claim 28] via: “.. wherein the identity of the consumer is masked or anonymized..”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard and Shelton with Kenedy. Willard and Shelton teach managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted in addition to recruitment of patients to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies. However, Willard and Shelton fail to disclose filtering the data wherein the identity of the consumer is masked or anonymized as taught by Kenedy. Combining Willard, Shelton and Kenedy is helpful for patients who may be interested in participating in clinical trials pertaining to their particular disease or disorder but who wish to maintain their anonymity.
Regarding claim 20: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. However Willard and Shelton are silent the following claim that is taught by Kenedy:
wherein the third party is a pharmaceutical company. (See at least [0031] via: “..The individual controls access to the data contained in their EHR, and as such, the individual can initiate and record authorizations in the EHR system for each medical provider or medical establishment that the individual would like to have access pangenetic data in their EHR. In another embodiment the EHR may alternatively exist in the form of a Personal Health Record (PHR), which is an Electronic Health Record which includes data from EMRs as well as data entered by the individual themself. Similarly to an EHR, the individual must provide authorization in order for others to be able to access the pangenetic and other data contained in their PHR..”; in addition see at least [0032] via: “..Within this disclosure, .. The term `healthcare`, ... When used with respect to the healthcare industry, the term `establishments` can refer to ..., pharmacies, ... and pharmaceutical companies, for example...”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard and Shelton with Kenedy. Willard and Shelton teach managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted in addition to recruitment of patients to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies. However, Willard and Shelton fail to disclose that the third party requesting medical records to perform clinical research is a pharmaceutical company as taught by Kenedy. Combining Willard, Shelton and Kenedy is helpful for patients who may be interested in participating in clinical trials pertaining to their particular disease or disorder and to pharmaceutical companies interested in researching which pharmaceutical products are best suited for specific diseases.
Regarding claim 21: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. However Willard and Shelton are silent the following claim that is taught by Kenedy:
wherein the third party is a biomedical company. (See at least [0031] via: “..The individual controls access to the data contained in their EHR, and as such, the individual can initiate and record authorizations in the EHR system for each medical provider or medical establishment that the individual would like to have access pangenetic data in their EHR. In another embodiment the EHR may alternatively exist in the form of a Personal Health Record (PHR), which is an Electronic Health Record which includes data from EMRs as well as data entered by the individual themself. Similarly to an EHR, the individual must provide authorization in order for others to be able to access the pangenetic and other data contained in their PHR..”; in addition see at least [0032] via: “..Within this disclosure, .. The term `healthcare`, ... When used with respect to the healthcare industry, the term `establishments` can refer to ... biomedical research facilities, clinical research centers, biotechnology companies .., for example..”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard and Shelton with Kenedy. Willard and Shelton teach managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted in addition to recruitment of patients to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies. However, Willard and Shelton fail to disclose that the third party requesting medical records to perform clinical research is a biomedical company as taught by Kenedy. Combining Willard, Shelton and Kenedy is helpful for patients who may be interested in participating in clinical trials pertaining to their particular disease or disorder and to biomedical companies interested in researching which biomedical products are best suited for specific diseases.
Claim 18 is rejected under 35 U.S.C. 103 as being un-patentable by Willard in view of Shelton, in further view of Yousfi et.al (WO 2018005562 A1) hereinafter “Yousfi”
Regarding claim 18: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. However Willard and Shelton are silent the following claim that is taught by Yousfi:
comprising recording in the computer-readable memory information indicative of transmission of the data included in the individual ones of the health records to the third party for traceability. (See at least [0007] via: “...a system for providing cross- border health data transfer while preserving patient privacy comprises: a data storage device storing instructions for providing cross-border health data transfer while preserving patient privacy; and a processor configured for: receiving patient- specific health data including patient privacy information at a first region; removing the patient privacy information from the patient-specific health data to generate anonymous health data; storing the patient privacy information at the first region; and transmitting the anonymous health data to a second region for analysis...”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard and Shelton with Yousfi. Willard and Shelton teach managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted in addition to recruitment of patients to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies. However, Willard and Shelton fail to disclose a data storage device storing instructions for providing health data transfer while preserving patient privacy as taught by Yousfi. Combining Willard, Shelton and Yousfi is helpful for patients and third parties requesting patient data to have a traceable stored record pertaining to the transfer of patient data.
Claim 19 is rejected under 35 U.S.C. 103 as being un-patentable by Willard in view of Shelton, in further view of Calabrese et.al (US 20050075543 A1) hereinafter “Calabrese”
Regarding claim 19: Willard and Shelton teach the invention as claimed and detailed above with respect to claim 10. However Willard and Shelton are silent the following claim that is taught by Calabrese:
comprising, in response to the research identifying an anomalous condition in the data included in a given health record of the individual ones of the health records that is about a given patient of the individual ones of the patients, notifying the given patient of the anomalous condition. (See at least [0015] via: “...determining if the patient has a positive test result for a human malady or predisposition to a human malady, and providing or making available information regarding the human malady or the predisposition to a human malady to the patient prior to providing the test result...”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Willard and Shelton with Calabrese. Willard and Shelton teach managing customizing patient consent policies, whereby an electronic medical record (EMR) receives selected medical information exchange consent policy elements from a patient, accepts from a third party a medical record request for the patient, filters the complete medical record for the patient in accordance with the selected medical information exchange consent policy elements to form a consent-filtered medical record and transfers the consent-filtered medical record to a third party, where consent policies may be defined within a practice to control which portions of the medical record, if any, should be redacted in addition to recruitment of patients to allow conductors of research studies pertaining to specific diseases or disorders to access private records and locate appropriate research subjects interested in participating in clinical research studies. However, Willard and Shelton fail to disclose determining if the patient has a positive test result for a human malady, and providing information regarding the human malady to the patient as taught by Calabrese. Combining Willard, Shelton and Calabrese is helpful for patients who may be interested in participating in clinical trials pertaining to their particular disease or disorder to receive feedback regarding results of the clinical trials.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure, and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Lara (US 20060178913 A1) - Medical And Other Consent Information Management System - teaches: A system allows healthcare personnel to automatically associate patient related activities to an appropriate consent form and track the status of consent forms electronically. A consent information management system suitable for healthcare use, comprises at least one repository associating consent information of a particular patient with data identifying, a corresponding particular treatment provided to the particular patient and signatures validating consent obtained from the particular patient and other persons. A consent data processor uses the at least one repository and determines signatures required for a particular consent for providing a particular treatment to a particular patient are obtained.
Gaddam (US 20160358287 A1) - Method For Filtering Medical Information Exchange Consent Policy Data Of Patient At E.g. Hospital, Involves Transferring Consent Filtered Medical Record From Electronic Medical Record Appliance To Each Of Medical Record Requesters - teaches: filtering a medical record for a patient at an electronic medical record (EMR) appliance (102) in accordance with individual pre-populated selectable medical information exchange policy elements and overridden individual selectable medical information exchange policy elements to form a consent filtered medical record. Sections of the medical record are redacted according to an applicable redaction indicator. The consent filtered medical record is transferred from the EMR appliance to each of medical record requesters in response to a medical record request.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
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/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684