DETAILED ACTION
Status of the Claims
The following is a non-final Office Action in response to restriction requirement filed 16 February 2026
Claims 1-19 have been restricted.
Claims 1-16 have been elected with traverse.
Claims 17-19 have been withdrawn.
Claims 1-16 are pending and have been examined.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 July 2025 are being considered by the Examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application(s) 17/751,931 which claims priority to provisional Application 63/192,572 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Claim Objections
Claim 15 is objected to because of the following informalities: The claim has the acronym “HCP” without further defining the term which renders the claim unclear and indefinite. The use of acronyms is permitted however they must first be defined whenever the acronym is first claimed in order to establish the proper metes and bounds of the claim. Appropriate correction is required.
Claims 16 are objected to because of the following informalities: The claims have the acronym “NLP” without further defining the term which renders the claim unclear and indefinite. The use of acronyms is permitted however they must first be defined whenever the acronym is first claimed in order to establish the proper metes and bounds of the claim. Appropriate correction is required.
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-16 in the reply filed on 16 February 2026 is acknowledged. The traversal is on the ground(s) that the claims are capable of use together as a unified healthcare information platform; however the Examiner respectfully disagrees. This is not found persuasive because the claims clearly recite distinct inventions with differences not only in scope, but also differ functionally and field of endeavor, which would create a search burden. The only overlap in scope within the distinct inventions is the intended use area of healthcare as calendaring/appointment management, communication and electronic record keeping, which has to be regulated, are vastly different concepts and mutually exclusive (as noted in the previous action with the different classifications). Simply being able to be used together within some sort of unified healthcare system does not amount to an adequate traverse.
The requirement is still deemed proper and is therefore made FINAL.
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 1-16 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims are directed to a process (an act, or series of acts or steps), a machine (a concrete thing, consisting of parts, or of certain devices and combination of devices), and a manufacture (an article produced from raw or prepared materials by giving these materials new forms, qualities, properties, or combinations, whether by hand labor or by machinery). Thus, each of the claims falls within one of the four statutory categories (Step 1). The claims recite a method (process) and system with apparatuses, however, the claim(s) recite(s) message content moderation with respect to compliance policies which is an abstract idea of organizing human activities as well as a mental process.
The limitations of:
In claim 1: “a content moderation function that analyzes content for compliance with a content policy that maintains separation between medical and commercial communications; wherein said content policy is determined according to healthcare regulations and organizational guidelines regarding separation of medical and commercial roles; wherein said content moderation function comprises an artificial intelligence system configured to: identify whether a communication is commercial or medical in nature; route messages to appropriate personnel based on content type; ensure medical personnel remain independent from commercial influence; maintain separation between promotional and non-promotional content; and log and track all communications for compliance purposes; wherein said server verifies recipient credentials before relaying messages containing medical information or product details to ensure recipients have appropriate licenses to receive such information; wherein said content moderation function ensures consistent messaging across multiple communication channels while maintaining appropriate role- based access control between medical and commercial personnel,”
In claim 15: “initiating transmission of patient-specific medical information through the messaging modality to the computational device by one or more of an HCP, HCP staff member and/or external support staff member; generating, under control of one or more computer systems, a message that provides the patient specific medical information and that includes message content, and recipient identification data for the patient; reviewing the message content for compliance by a computer system; sending the message to the patient if compliance has been established; confirming a delivery of the message to the patient; and generating an audit trail that is configured to create a historical record corresponding to said message”
...as drafted, is a process that, under its broadest reasonable interpretation, covers organizing human activities--fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) or a mental process—concepts performed in the human mind (including an observation, evaluation, judgment, opinion) but for the recitation of generic computer components (Step 2A Prong 1). That is, other than reciting “A system for supporting secure healthcare professional communication, comprising: a computer network; a sending user computational device; a server; and a recipient user computational device...,” (or “A method for increasing reliability of messaging communication through a messaging modality with a patient, wherein the messaging modality is executed through a computational device by the patient, the method comprising:...under the control of one or more computer systems” in claim 15) nothing in the claim element precludes the step from the methods of organizing human interactions grouping or from practically being performed in the mind. For example, but for the “A system for supporting secure healthcare professional communication, comprising: a computer network; a sending user computational device; a server; and a recipient user computational device...,” (or “A method for increasing reliability of messaging communication through a messaging modality with a patient, wherein the messaging modality is executed through a computational device by the patient, the method comprising:” in claim 15) language, “analyzes,” identify,” “verifies,” (in claim 1) “initiating,” “generating,” “reviewing,” “sending,” “confirming” and “generating,” in claims 8 and 15 in the context of this claim encompasses the user manually reading messages which could need moderation or redaction of patient information which is a method of organizing human activities (following rules instructions based upon a policy which is also a commercial/legal interaction) as well as a mental process/judgement of whether or not content needs moderation based upon a policy. However, if possible, the Examiner should consider the limitations together as a single abstract idea rather than as a plurality of separate abstract ideas to be analyzed individually. “For example, in a claim that includes a series of steps that recite mental steps as well as a mathematical calculation, an examiner should identify the claim as reciting both a mental process and a mathematical concept for Step 2A, Prong One to make the analysis clear on the record.” MPEP 2106.04, subsection II.B. Under such circumstances, however, the Supreme Court has treated such claims in the same manner as claims reciting a single judicial exception. Id. (discussing Bilski v. Kappos, 561 U.S. 593 (2010)). Here, the limitations are considered together as a single abstract idea for further analysis. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitations as a mathematical concept, while some of the limitations may be performed in the mind after certain limitations are performed, but for the recitation of generic computer components, then it falls within the grouping of abstract ideas. (Step 2A, Prong One: YES). Accordingly, the claim(s) recite(s) an abstract idea.
This judicial exception is not integrated into a practical application (Step 2A Prong Two). The “A system for supporting secure healthcare professional communication, comprising: a computer network; a sending user computational device; a server; and a recipient user computational device; wherein said sending user computational device, said server and said recipient user computational device communicate through said computer network; wherein each of said sending user computational device, said recipient user computational device and said server comprises a memory for storing instructions and a processor for executing said instructions; wherein each of said sending user computational device and said recipient user computational device comprises a messaging modality; wherein said sending user computational device creates a message according to a template determined according to at least one policy; wherein said message is sent from said sending user computational device to said server and is addressed according to an address associated with said messaging modality; wherein said server relays said message according to said address to said recipient user computational device; wherein said address of said sending user computational device and said recipient user computational device are each masked” in claim 1 is simply the computational device elements that send and receive data which only amount to insignificant data gathering activities. Next, the claim only recites one additional element – using a server or one or more computer systems to perform the steps. The server or one or more computer systems steps is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Specifically the claims amount to nothing more than an instruction to apply the abstract idea using a generic computer or invoking computers as tools by adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d)(I) discussing MPEP 2106.05(f). The claims recitation of the “A system for supporting secure healthcare professional communication, comprising: a computer network; a sending user computational device; a server; and a recipient user computational device; wherein said sending user computational device, said server and said recipient user computational device communicate through said computer network; wherein each of said sending user computational device, said recipient user computational device and said server comprises a memory for storing instructions and a processor for executing said instructions; wherein each of said sending user computational device and said recipient user computational device comprises a messaging modality; wherein said sending user computational device creates a message according to a template determined according to at least one policy; wherein said message is sent from said sending user computational device to said server and is addressed according to an address associated with said messaging modality; wherein said server relays said message according to said address to said recipient user computational device; wherein said address of said sending user computational device and said recipient user computational device are each masked” are only generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.04(d)(I) discussing MPEP 2106.05(h). Similarly, the recitation of “artificial intelligence system” in the limitations also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “artificial intelligence system” limits the identified judicial exceptions, this type of limitation merely confines the use of the abstract idea to a particular technological environment (artificial intelligence) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h). Accordingly, the combination of these additional elements does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea, even when considered as a whole (Step 2A Prong Two: NO).
The claim does not include a combination of additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B). As discussed above with respect to integration of the abstract idea into a practical application (Step 2A Prong 2), the combination of additional elements of using server or one or more computer systems to perform the steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Reevaluating here in step 2B, the “A system for supporting secure healthcare professional communication, comprising: a computer network; a sending user computational device; a server; and a recipient user computational device; wherein said sending user computational device, said server and said recipient user computational device communicate through said computer network; wherein each of said sending user computational device, said recipient user computational device and said server comprises a memory for storing instructions and a processor for executing said instructions; wherein each of said sending user computational device and said recipient user computational device comprises a messaging modality; wherein said sending user computational device creates a message according to a template determined according to at least one policy; wherein said message is sent from said sending user computational device to said server and is addressed according to an address associated with said messaging modality; wherein said server relays said message according to said address to said recipient user computational device; wherein said address of said sending user computational device and said recipient user computational device are each masked” in the claim which are insignificant extrasolution activities are also determined to be well-understood, routine and conventional activity in the field. The Symantec, TLI, and OIP Techs court decisions in MPEP 2106.05(d)(II) indicate that the mere receipt or transmission of data over a network is well-understood, routine, and conventional function when it is claimed in a merely generic manner (as is here). Therefore, when considering the additional elements alone, and in combination, there is no inventive concept in the claim. As such, the claim(s) is/are not patent eligible, even when considered as a whole (Step 2B: NO).
Claims 2-3 recite(s) the additional limitation(s) further limiting the device and environment (network) which is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1 and 15, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claim 4 recite(s) the additional limitation(s) further limiting the users of the devices which is still directed towards the abstract idea(s) previously identified and is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1 and 15, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claim 5, 9-10, and 16 recite(s) the additional limitation(s) which include mathematical concepts (another abstract idea) which is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1 and 15, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claims 6-8 and 11-14 recite(s) the additional limitation(s) further limiting the message content, routing, and rules thereof, which is still directed towards the abstract idea(s) previously identified and is not an inventive concept that meaningfully limits the abstract idea. Again, as discussed with respect to claims 1 and 15, the claims are simply limitations which are no more than mere instructions to apply the exception using a computer or with computing components. Accordingly, the additional element(s) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Even when considered as a whole, the claims do not integrate the judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claims 1-16 are therefore not eligible subject matter, even when considered as a whole.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Redei (US PG Pub. 2018/0199815).
As per claim 15, Redei discloses method for increasing reliability of messaging communication through a messaging modality with a patient, wherein the messaging modality is executed through a computational device by the patient, the method comprising (network, devices, HIPAA-compliant, Redei ¶61; HL7, ¶4; social network with bidirectional secure messaging, SMS messaging, ¶33-¶34; API, database, server, software, ¶58):
initiating transmission of patient-specific medical information through the messaging modality to the computational device by one or more of an HCP, HCP staff member and/or external support staff member (The system incorporates a scalable cloud-based social network architecture that manages the Health Insurance Portability and Accountability Act (HIPAA) compliant exchange of personal health information, including encrypted file transfer and messaging, between the participants of the social network. The exchange of diagnostic information is permission-based and allows referrals to specialists to improve the diagnostic certainty, and is augmented by a data analytics center, ¶22; The other local health management systems may include EMRs 840, PACS 846, or other systems 842 supporting HL7 messaging protocols, such as laboratory information management systems (LIMS). The plugins 841 may allow import (or export) of data from/to such systems to the local case administration layer 829, ¶64);
generating, under control of one or more computer systems, a message that provides the patient specific medical information and that includes message content, and recipient identification data for the patient (The system incorporates a scalable cloud-based social network architecture that manages the Health Insurance Portability and Accountability Act (HIPAA) compliant exchange of personal health information, including encrypted file transfer and messaging, between the participants of the social network. The exchange of diagnostic information is permission-based and allows referrals to specialists to improve the diagnostic certainty, and is augmented by a data analytics center, ¶22);
reviewing the message content for compliance by a computer system; sending the message to the patient if compliance has been established; confirming a delivery of the message to the patient (natural language processing, text mining, Redei ¶93; The data anonymizer unit 922 may be configured to receive patient data associated with the health care diagnostics of a patient and to remove at least a portion of patient identifying information from the received patient data to generate first anonymized data, ¶100; The system incorporates a scalable cloud-based social network architecture that manages the Health Insurance Portability and Accountability Act (HIPAA) compliant exchange of personal health information, including encrypted file transfer and messaging, between the participants of the social network. The exchange of diagnostic information is permission-based and allows referrals to specialists to improve the diagnostic certainty, and is augmented by a data analytics center, ¶22; In some embodiments, the data from the patient may be anonymized and aggregated with anonymized data from other patients. The anonymized aggregated data may further be utilized by pharmaceutical companies for generating peri- or post-approval data and demonstrating real-world evidence of a favorable risk/benefit ratio, for instance, for reimbursement purposes, ¶120); and
generating an audit trail that is configured to create a historical record corresponding to said message (The social network infrastructure 837 may include a scalable, cloud-based case content delivery network 839 that manages a HIPAA-compliant exchange of personal health information, including full audit trail, encrypted file transfer, and messaging between participants of a social network hosted by the social network infrastructure 837, Redei ¶58).
As per claim 16, Redei discloses as shown above with respect to claim 15, Redei further discloses wherein said reviewing the message content for compliance comprises analyzing the message content by a NLP algorithm and preventing the message from being sent if non-compliant content is detected; wherein said non- compliant content comprises content that includes patient specific medical details that are protected under medical regulations (The data anonymizer unit 922 may be configured to receive patient data associated with the health care diagnostics of a patient and to remove at least a portion of patient identifying information from the received patient data to generate first anonymized data, Redei ¶100; The system incorporates a scalable cloud-based social network architecture that manages the Health Insurance Portability and Accountability Act (HIPAA) compliant exchange of personal health information, including encrypted file transfer and messaging, between the participants of the social network. The exchange of diagnostic information is permission-based and allows referrals to specialists to improve the diagnostic certainty, and is augmented by a data analytics center, ¶22; In some embodiments, the data from the patient may be anonymized and aggregated with anonymized data from other patients. The anonymized aggregated data may further be utilized by pharmaceutical companies for generating peri- or post-approval data and demonstrating real-world evidence of a favorable risk/benefit ratio, for instance, for reimbursement purposes, ¶120) (Examiner notes the anonymizing the data as the detection and prevention of non-compliant content i.e. the system of Redei will not send the messages if sensitive material is detected).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Redei (US PG Pub. 2018/0199815) and further in view of Burk et al. (US PG Pub. 2011/0137673) and Nagaraja et al. (US PG Pub. 2020/0244605).
As per claim 1, Redei discloses a system for supporting secure healthcare professional communication, comprising: a computer network; a sending user computational device; a server; and a recipient user computational device; wherein said sending user computational device, said server and said recipient user computational device communicate through said computer network; wherein each of said sending user computational device, said recipient user computational device and said server comprises a memory for storing instructions and a processor for executing said instructions; wherein each of said sending user computational device and said recipient user computational device comprises a messaging modality (network, devices, HIPAA-compliant, Redei ¶61; HL7, ¶4; social network with bidirectional secure messaging, SMS messaging, ¶33-¶34; API, database, server, software, ¶58);
wherein said sending user computational device creates a message according to a template determined according to at least one policy; wherein said message is sent from said sending user computational device to said server and is addressed according to an address associated with said messaging modality; wherein said server relays said message according to said address to said recipient user computational device; wherein said address of said sending user computational device and said recipient user computational device are each masked (anonymization format, Redei ¶45; diagnostics delivered in a format, Redei ¶4 and ¶37; see also The other local health management systems may include EMRs 840, PACS 846, or other systems 842 supporting HL7 messaging protocols, such as laboratory information management systems (LIMS). The plugins 841 may allow import (or export) of data from/to such systems to the local case administration layer 829, ¶64) (Examiner interprets the specific type of formatting for anonymization of messages/reports as the templates);
wherein said server comprises a content moderation function that analyzes content for compliance with a content policy that maintains separation between medical and commercial communications; wherein said content policy is determined according to healthcare regulations and organizational guidelines regarding separation of medical and commercial roles (natural language processing, text mining, Redei ¶93; The data anonymizer unit 922 may be configured to receive patient data associated with the health care diagnostics of a patient and to remove at least a portion of patient identifying information from the received patient data to generate first anonymized data, ¶100; The system incorporates a scalable cloud-based social network architecture that manages the Health Insurance Portability and Accountability Act (HIPAA) compliant exchange of personal health information, including encrypted file transfer and messaging, between the participants of the social network. The exchange of diagnostic information is permission-based and allows referrals to specialists to improve the diagnostic certainty, and is augmented by a data analytics center, ¶22; In some embodiments, the data from the patient may be anonymized and aggregated with anonymized data from other patients. The anonymized aggregated data may further be utilized by pharmaceutical companies for generating peri- or post-approval data and demonstrating real-world evidence of a favorable risk/benefit ratio, for instance, for reimbursement purposes, ¶120);
wherein said server verifies recipient credentials before relaying messages containing medical information or product details to ensure recipients have appropriate licenses to receive such information; wherein said content moderation function ensures consistent messaging across multiple communication channels while maintaining appropriate role- based access control between medical and commercial personnel (The data anonymizer unit 922 may be configured to receive patient data associated with the health care diagnostics of a patient and to remove at least a portion of patient identifying information from the received patient data to generate first anonymized data, Redei ¶100; see also ¶45) (Examiner notes the medical/patient data is determined and protected under HIPPA which is the governing body for licensed and certified HCPs).
Redei does not expressly disclose wherein said content moderation function comprises an artificial intelligence system configured to: identify whether a communication is commercial or medical in nature; route messages to appropriate personnel based on content type; ensure medical personnel remain independent from commercial influence; maintain separation between promotional and non-promotional content; and log and track all communications for compliance purposes.
However, Burk discloses wherein said content moderation function comprises a...system configured to: identify whether a communication is commercial or medical in nature; route messages to appropriate personnel based on content type; ensure medical personnel remain independent from commercial influence; maintain separation between promotional and non-promotional content; and log and track all communications for compliance purposes (HCP can be a patient, Burk ¶3; privacy component, ¶48; level of isolation from the promotional activities carried out by pharmaceutical industry, ¶49; FIG. 3 is a continuation of FIG. 2 in that it further explodes a request to pharmaceutical manufacturers 140 selection. Shown is a request from pharmaceutical manufacturers 140, which further expands into a request for product samples 142 that includes a product selection 144, and a strength and dose selection 146; a request product information 148 which expands into a product selection 144, and a delivery method selection 154; a request for a contact from pharmaceutical representative 156 which further expands into a product selection 144, and a contact type selection 160; a request for patient education materials 162, which further expands into a product selection 144, and a manual type and quantity, strength or dose selection 168; an Anonymous Communication with Manufacturer 131, which expands into a Manufacturer selection 132, a Message type selection 133, an Email of message to manufacturer 134, a Manufacturers response 135, a Physician notified of the response 136, and a Physician reply to the response from Manufacturer 137; and a request indigent patient support 170. A request for indigent patient support 170 is designed to invoke the assistance of promotional and community relations services, that are run by pharmaceutical manufacturers as means of promoting their image and their products, to assist needy patients. FIG. 3 further discloses that all selections listed above end up in an electronic shopping cart 175 and then proceed to checkout 180. Sometimes, as in instances where a drug sample is requested, a PDMA compliant document generation 190 takes place. Such a PDMA compliant document 90 is sent to a requesting HCP and is preferably in a PDF format, or any format commonly used in the art. To further verify that all selections are correct, an HCP needs to confirm with the order confirmation 200, which generates a confirmatory email 210, ¶51).
Both the Burk and Redei references are analogous in that both are directed towards/concerned with healthcare messaging and security thereof. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Burk’s ability to provide information related to pharmaceutical information in Redei’s system to improve the system and method with reasonable expectation that this would result in a healthcare communication management system that is more secure and reliable.
The motivation being that presently, drug manufactures use a variety of methods to promote their products. One of typical methods is through the help of a sales team. However, not all HCP are covered equally by pharmaceutical representatives. An HCP may be overlooked by a sales team if he or she practices in a remote location, or if the sales team is insufficiently represented in a particular HCP's area, or if treatment activities by a particular HCP do not amount to a level sufficient in justifying direct contact by a sales team. Therefore, such an HCP may find it difficult to find relevant information, drug samples, and access to various other information. In addition, some HCPs have irregular office hours, or they complete all of their prescription work in the evening, after seeing patients, when a visit by a sales representative is highly unlikely. For this reason the HCP requires an alternative means of accessing pharmaceutical information supplied by representative, yet no satisfactory means currently exists. There is a need for a single place where objective information about pharmaceutical resources, for example, products, samples and communications can be obtained with out the need to visit a multitude of different sources (Burk ¶5).
The combination of Redei and Burk do not expressly disclose the use of an artificial intelligence system.
However, Nagaraja teaches an artificial intelligence system (artificial intelligence assisted service provisioning and modification for message-based services, Nagaraja ¶4; neural network, ¶104; HIPAA sensitive and non-HIPAA sensitive content, ¶113).
The Nagaraja, Burk, and Redei references are analogous in that both are directed towards/concerned with healthcare messaging and security thereof. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Nagaraja’s ability to incorporate artificial intelligence in message based services in Burk’s and Redei’s system to improve the system and method with reasonable expectation that this would result in a healthcare communication management system that is more secure and reliable.
The motivation being that presently, drug manufactures use a variety of methods to promote their products. One of typical methods is through the help of a sales team. However, not all HCP are covered equally by pharmaceutical representatives. An HCP may be overlooked by a sales team if he or she practices in a remote location, or if the sales team is insufficiently represented in a particular HCP's area, or if treatment activities by a particular HCP do not amount to a level sufficient in justifying direct contact by a sales team. Therefore, such an HCP may find it difficult to find relevant information, drug samples, and access to various other information. In addition, some HCPs have irregular office hours, or they complete all of their prescription work in the evening, after seeing patients, when a visit by a sales representative is highly unlikely. For this reason the HCP requires an alternative means of accessing pharmaceutical information supplied by representative, yet no satisfactory means currently exists. There is a need for a single place where objective information about pharmaceutical resources, for example, products, samples and communications can be obtained with out the need to visit a multitude of different sources (Burk ¶5).
Burk and Redei references are analogous in that both are directed towards/concerned with healthcare messaging and security thereof. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Burk’s ability to provide information related to pharmaceutical information in Redei’s system to improve the system and method with reasonable expectation that this would result in a healthcare communication management system that is more secure and reliable.
The motivation being that there exists a need for an effective, efficient, responsive, and self-evolving system for providing services to users in a personalized and holistic manner (Nagaraja, ¶7).
In addition, the Examiner asserts that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are: (A) "adapted to" or "adapted for" clauses; (B) "wherein" clauses; and (C) "whereby" clauses (See MPEP 2111.04). In the instant case, the recited aspects of "... that maintains separation between medical and commercial communications" and “to ensure medical personnel remain independent from commercial influence” are not a system element as it do not require any actual positive recited claim steps to be performed; nor does it structurally limit the system and merely describes the intended use of the system and/or the intended result of the use of the system.
As per claim 2, Redei, Burk and Nagaraja disclose as shown above with respect to claim 1. Redei further discloses wherein said messaging modality comprises a modality selected from the group consisting of a modality addressed through a telephone number, a social media modality, an email modality, a voice modality, a chat modality, a text modality and a video modality (e-mail, message, social network, Redei ¶29; SMS messaging, ¶34; call, ¶45; voice, video, ¶112).
As per claim 3, Redei, Burk and Nagaraja disclose as shown above with respect to claim 2. Redei further discloses wherein said messaging modality comprises a third-party communication service that: is separately installed or configured on said computational devices; operates using its own proprietary protocols and authentication systems; requires separate access credentials from the main system; and functions independently of the main system's core operations; wherein said message is transmitted through a separate network associated with said third-party communication service to said recipient user computational device, wherein said server sends said message to said separate network for delivery through said third- party communication service (third party service provider, Redei ¶37; The social network infrastructure 837 may include a scalable, cloud-based case content delivery network 839 that manages a HIPAA-compliant exchange of personal health information, including full audit trail, encrypted file transfer, and messaging between participants of a social network hosted by the social network infrastructure 837, ¶58).
As per claim 4, Redei, Burk and Nagaraja disclose as shown above with respect to claim 1. Redei further discloses wherein said sending user computational device comprises an external support staff user computational device and said recipient user computational device comprises a healthcare professional computational device (FIG. 5 is a diagram illustrating an example data flow of adding new information 516 to a case within a social network 500 for personalized medicine, arranged in accordance with at least some embodiments described herein. In particular, FIG. 5 illustrates information 516 being added by a specialist neurologist 512 that is associated with a PCP 510 and a radiologist 514 in the social network 500. The PCP 510 and/or the specialist neurologist 512 may further refer to/consult a data analytics center 518, to generate, for example, an integrated report concerning health care of the patient. The integrated report may be added to the case by the data analytics center 518, Redei ¶54; FIG. 6 is a diagram illustrating example diagnostic and therapeutic data flow within a social network 600 for personalized medicine, arranged in accordance with at least some embodiments described herein. In particular, the FIG. 6 illustrates the diagnostic and therapeutic data flow in the personalized medicine platform for Alzheimer's disease between the participants of the social network 600. For example, FIG. 6 illustrates that a PCP 610 may take a cognitive screen test 620 of a patient, which may include ordering an APOE testing and/or a blood screening test for Alzheimer's disease that is performed at a Lab 616. The PCP 610 may, after receiving the laboratory reports, consult a data analytics center 624, to consolidate the screening data into an integrated report. The PCP 610 may also refer the patient case to a specialist neurologist 612 for further evaluation of the patient. These step by the PCP 610 may conclude the screening episode of care for the patient. The specialist neurologist 612 may order another IVD test from the lab 616. The IVD test may entail CSF Abeta/Tau testing. The specialist neurologist 612 may further complete a comprehensive exam 618 on the patient that may, in some embodiments, include a full computerized cognitive battery. The specialist neurologist 612 may further refer/order a MRI and/or PET scan 622 from a radiologist 614, which may include image quantitation. The specialist neurologist 612 may then consult the data analytics center 624, to consolidate the comprehensive evaluation data into an integrated report. These steps by the specialist neurologist 612 may conclude a comprehensive diagnostics episode of care. In some embodiments, the data analytics center 624 may generate a predictive report for therapeutic stratification, as mentioned above, that may provide actionable information for the specialist neurologist 612, or the PCP 610 for prescribing a personalized drug for the patient related to Alzheimer's disease. In some embodiments, the PCP 610, may, augmented by the data analytics center 624, perform some or all of the functions of comprehensive evaluation as mentioned above and/or subsequent therapeutic stratification prior to prescribing the personalized drug, ¶55).
As per claim 5, Redei, Burk and Nagaraja disclose as shown above with respect to claim 1. Redei further discloses wherein said artificial intelligence system analyses said content according to a natural language processing (NLP) machine learning algorithm (natural language processing, text mining, Redei ¶93).
Nagaraja further teaches wherein said artificial intelligence system further receives additional information about a sending user and a recipient user, and further analyzes said content according to said additional information (artificial intelligence assisted service provisioning and modification for message-based services, Nagaraja ¶4; neural network, ¶104; HIPAA sensitive and non-HIPAA sensitive content, ¶113).
As per claim 6, Redei, Burk and Nagaraja disclose as shown above with respect to claim 5. Nagaraja further teaches further comprising a supervisory user computational device, wherein if said message from said sending user computational device is determined to violate said content policy by said artificial intelligence system, said artificial intelligence system sends said message to said supervisory user computational device for review (For example, medical guidelines, protocols, best practice knowledge can be used as medical domain knowledge, thereby forming the basis to generate rulesets and corresponding diagnostic questionnaires that are invoked in response to a user's request for clinical services. In some embodiments, transforming and/or mapping the guidelines, protocols and best practice knowledge into rulesets and diagnostic questionnaires can be performed by human operators (e.g., Jiseki engineers). In some embodiments, such transforming and/or mapping can be performed automatically and/or reviewed by human operators, using techniques such as artificial intelligence, and the like. In some embodiments, domain knowledge based rulesets and diagnostic questionnaires can be obtained from third party providers, Nagaraja ¶87).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Burk’s ability to provide information related to pharmaceutical information in Redei’s system to improve the system and method with reasonable expectation that this would result in a healthcare communication management system that is more secure and reliable.
The motivation being that there exists a need for an effective, efficient, responsive, and self-evolving system for providing services to users in a personalized and holistic manner (Nagaraja, ¶7).
As per claim 7, Redei, Burk and Nagaraja disclose as shown above with respect to claim 5. Nagaraja further teaches wherein said artificial intelligence system further comprises a coaching function; wherein said content of said message is analyzed for one or more of policy violations, clarity, word choice or tone; wherein said artificial intelligence system further determines that coaching is required according to said analysis of said content; wherein said coaching function of said artificial intelligence system provides one or more suggestions to adjust said content to said sending user computational device (suggestions from platform, Nagaraja ¶136).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use Burk’s ability to provide information related to pharmaceutical information in Redei’s system to improve the system and method with reasonable expectation that this would result in a healthcare communication management system that is more secure and reliable.
The motivation being that there exists a need for an effective, efficient, responsive, and self-evolving system for providing services to users in a personalized and holistic manner (Nagaraja, ¶7).
As per claim 5, Redei, Burk and Nagaraja disclose as shown above with respect to claim 1. Redei further discloses a method for increasing reliability of messaging communication through a messaging modality, implemented according to the system of claim 1; adapted for implementation with a healthcare provider (HCP), wherein the messaging modality is executed through a computational device by the HCP, the method comprising :receiving a request for medical information through the messaging modality; generating, under control of one or more computer systems, a message that provides the medical information and that includes message content, and recipient identification data for the HCP; reviewing the message content for compliance by a computer system; sending the message to the HCP if compliance has been established; confirming a delivery of the message to the HCP; and generating an audit trail that is configured to create a historical record corresponding to said message (The social network infrastructure 837 may include a scalable, cloud-based case content delivery network 839 that manages a HIPAA-compliant exchange of personal health information, including full audit trail, encrypted file transfer, and messaging between participants of a social network hosted by the social network infrastructure 837, Redei ¶58; he data anonymizer unit 922 may be configured to receive patient data associated with the health care diagnostics of a patient and to remove at least a portion of patient identifying information from the received patient data to generate first anonymized data, ¶100; The system incorporates a scalable cloud-based social network architecture that manages the Health Insurance Portability and Accountability Act (HIPAA) compliant exchange of personal health information, including encrypted file transfer and messaging, between the participants of the social network. The exchange of diagnostic information is permission-based and allows referrals to specialists to improve the diagnostic certainty, and is augmented by a data analytics center, ¶22; In some embodiments, the data from the patient may be anonymized and aggregated with anonymized data from other patients. The anonymized aggregated data may further be utilized by pharmaceutical companies for generating peri- or post-approval data and demonstrating real-world evidence of a favorable risk/benefit ratio, for instance, for reimbursement purposes, ¶120) (Examiner interprets the audit trail as the ability to confirm delivery and receipts of messages and the history thereof).
As per claim 9, Redei, Burk and Nagaraja disclose as shown above with respect to claim 8. Nagaraja further teaches wherein said reviewing the message content for compliance comprises analyzing the message content by a NLP algorithm and preventing the message from being sent if non-compliant content is detected; further comprising validating the message and/or a response from the HCP according to a contact detail and/or a parameter of the HCP (artificial intelligence assisted service provisioning and modification for message-based services, Nagaraja ¶4; neural network, ¶104; HIPAA sensitive and non-HIPAA sensitive content, ¶113; medical records exchange, ¶63; attached care plan, ¶166; links, level of priority, ¶79-¶80; lab report, ¶82).
As per claim 10, Redei, Burk and Nagaraja disclose as shown above with respect to claim 9. Nagaraja further teaches wherein said reviewing the message content for compliance comprises: analyzing the message through a multi-stage analysis pipeline comprising: examining message characteristics including sender role, recipient role, message content, attached files, and metadata; applying rule-based decisions and machine learning predictions to determine message handling; and checking the proposed communication against regulatory requirements and organizational policies; wherein said analyzing comprises identifying medical terminology, commercial terms, and regulatory keywords through natural language processing (artificial intelligence assisted service provisioning and modification for message-based services, Nagaraja ¶4; neural network, ¶104; HIPAA sensitive and non-HIPAA sensitive content, ¶113; attached care plan, ¶166; links, level of priority, ¶79-¶80; lab report, ¶82; based upon rulesets, steps, ¶82; determine medical topic, ¶83).
As per claim 11, Redei, Burk and Nagaraja disclose as shown above with respect to claim 10. Burk further teaches further comprising:implementing role-based access control comprising:maintaining separate communication channels for medical and commercial content;implementing distinct access privileges for each role; dynamically updating permissions based on: user role classification and credentials; communication context and content type; regulatory requirements for specific products or therapeutic areas; geographic location and applicable jurisdictional rules; and time-based restrictions and approval workflows (HCP can be a patient, Burk ¶3; privacy component, ¶48; level of isolation from the promotional activities carried out by pharmaceutical industry, ¶49; FIG. 3 is a continuation of FIG. 2 in that it further explodes a request to pharmaceutical manufacturers 140 selection. Shown is a request from pharmaceutical manufacturers 140, which further expands into a request for product samples 142 that includes a product selection 144, and a strength and dose selection 146; a request product information 148 which expands into a product selection 144, and a delivery method selection 154; a request for a contact from pharmaceutical representative 156 which further expands into a product selection 144, and a contact type selection 160; a request for patient education materials 162, which further expands into a product selection 144, and a manual type and quantity, strength or dose selection 168; an Anonymous Communication with Manufacturer 131, which expands into a Manufacturer selection 132, a Message type selection 133, an Email of message to manufacturer 134, a Manufacturers response 135, a Physician notified of the response 136, and a Physician reply to the response from Manufacturer 137; and a request indigent patient support 170. A request for indigent patient support 170 is designed to invoke the assistance of promotional and community relations services, that are run by pharmaceutical manufacturers as means of promoting their image and their products, to assist needy patients. FIG. 3 further discloses that all selections listed above end up in an electronic shopping cart 175 and then proceed to checkout 180. Sometimes, as in instances where a drug sample is requested, a PDMA compliant document generation 190 takes place. Such a PDMA compliant document 90 is sent to a requesting HCP and is preferably in a PDF format, or any format commonly used in the art. To further verify that all selections are correct, an HCP needs to confirm with the order confirmation 200, which generates a confirmatory email 210, ¶51).
As per claim 12, Redei, Burk and Nagaraja disclose as shown above with respect to claim 11. Nagaraja further teaches wherein said reviewing the message content for compliance further comprises: classifying message intent as promotional or non-promotional; identifying potentially restricted content or interactions; detecting attempted cross-boundary communications; implementing approval workflows for joint communications; and blocking restricted communication attempts (HIPAA sensitive and non-HIPAA sensitive content, ¶113; medical records exchange, ¶63; attached care plan, ¶166; links, level of priority, ¶79-¶80; lab report, ¶82; For example, medical guidelines, protocols, best practice knowledge can be used as medical domain knowledge, thereby forming the basis to generate rulesets and corresponding diagnostic questionnaires that are invoked in response to a user's request for clinical services. In some embodiments, transforming and/or mapping the guidelines, protocols and best practice knowledge into rulesets and diagnostic questionnaires can be performed by human operators (e.g., Jiseki engineers). In some embodiments, such transforming and/or mapping can be performed automatically and/or reviewed by human operators, using techniques such as artificial intelligence, and the like. In some embodiments, domain knowledge based rulesets and diagnostic questionnaires can be obtained from third party providers, ¶87; based upon permissions of their roles, ¶150).
As per claim 13, Redei, Burk and Nagaraja disclose as shown above with respect to claim 12. Nagaraja further teaches routing medical inquiries to medical personnel and commercial inquiries to appropriate commercial personnel based on automated content analysis; notifying all parties when a message is redirected; flagging messages containing promotional language in medical inquiry responses for review before transmission; and routing scenarios that cannot be automatically handled to supervisor or regulator review (message execution module 210 includes a listener 221, a communication module 222, an input cache 223, a router 224, and a response queue 225. In some embodiments, along an inbound path, listener 221 is configured to receive inputs incoming from the user to platform 206, and in turn forward the received inputs from the user to input cache 223 for forwarding to router 224, which eventually further forwards the received inputs to conversation management module 212 for processing. Along an outbound path, router 224 is configured to receive one or more responses in relation to the inputs from conservation management module 212, and store the received one or more responses in response queue 225, which in turn forwards the one or more responses to communicate module 222 including worker such as text worker 222-a, voice worker 222-b, video worker 222-c, email worker 222-d, and web worker 222-n, etc. Communication module 222 is configured to eventually transmit the one or more responses to the user as a result of receiving the inputs from the user according to the appropriate communication mode enabled by its workers, Nagaraja ¶59; routing based upon analysis of input, ¶69; flag requests, ¶75-¶76).
As per claim 14, Redei, Burk and Nagaraja disclose as shown above with respect to claim 13. Redei further discloses wherein generating said audit trail comprises: logging all communication attempts and their classification; documenting approved exceptions and their justification; recording all message transfers between personnel types; tracking response times and communication paths; archiving all communications for compliance review; monitoring for patterns that might indicate attempted circumvention of restrictions; and validating communication type against permitted interactions (The social network infrastructure 837 may include a scalable, cloud-based case content delivery network 839 that manages a HIPAA-compliant exchange of personal health information, including full audit trail, encrypted file transfer, and messaging between participants of a social network hosted by the social network infrastructure 837, Redei ¶58).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure (additional art can be located on the PTO-892):
Ahmad et al. (US PG Pub. 2015/0286790) System And Method For Secure Messaging.
Kenney et al. (US PG Pub. 2015/0350148) Healthcare secure messaging and reminder system
Plasse et al. (US PG Pub. 2015/0381571) System and method for securely managing medical interactions
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ANDREW B WHITAKER whose telephone number is (571)270-7563. The examiner can normally be reached on M-F, 8am-5pm, EST.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Lynda Jasmin can be reached on (571) 272-6782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW B WHITAKER/Primary Examiner, Art Unit 3629