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 .
Response to Amendment
In the amendment filed on December 23, 2025, the following has occurred: claim(s) 1, 6-8, 10-11 have been amended. Now, claim(s) 1-8, 10-11 are pending.
Claim Objections
Claim 1 objected to because of the following informalities: “a data, analytics, communication,” in p. 2, ll. 6 “they” in p. 2, ll. 17, “peer reviewed texts, journals health and clinical data,” in p. 3, ll. 1-2, “the problem-oriented health records,” in p. 3, ll. 7, “the peer reviewed health and clinical data,” in p. 3, ll. 7-8, “the patient’s care and health issues” in p. 3, ll. 14-15. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “a data, , communication,”, “the patient's social and environmental health determinants”, “peer reviewed texts and journals, health and clinical data,”, “the one or more problem-oriented health records”, “the peer reviewed texts and journals, health and clinical data,”, “the patient’s health and care issues”.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1: Step 2A Prong One
Claim 1 recite(s)
automatically import health and clinical data for use in analyzing the one or more patient problem-oriented health records and assessing diagnostic, treatment, and management options, guidance, communication and documentation for the health and care issues;
analyze the peer reviewed texts and journals, health and clinical data, information and knowledge, and operate in a combinatorial manner by assessing care and health implications of patient data in the one or more patient-oriented health records, the peer reviewed texts and journals, health and clinical data, and data coming in from remote patient monitoring devices to provide updated diagnostic, treatment, and management options for each of the one or more patient problem-oriented health records; and
a directory of community and virtual-based social services comprising vetted social service organizations for use by the patient in addressing one or more of the patient’s health and care issues and/or social and environmental health determinants
These limitations, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass using a computer as a tool to perform a mental process, which is a subgrouping of Mental Processes. That is other than reciting, “a patient terminal for providing he patient with an ability to interact with the system;”, “one or more patient data collection devices coupled to the patient terminal”, “an adaptive knowledge engine configured to”, “a source document repository for storing peer reviewed texts and journals, health and clinical data, information and knowledge”, “an artificial intelligence analytics engine configured to utilize machine learning and natural language processing functions to…”, the claim recites a Mental Process. For example, the claim encompasses a user importing health and clinical data for use in analyzing the one or more patient problem-oriented health records and assessing diagnostic, treatment, and management options for the health and care issues, a user analyzing the peer reviewed texts and journals, health and clinical data, information and knowledge, and a user identifying a directory of community and virtual-based social services. These steps could be accomplished by a user using a computer as a tool.
Claim 1: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining
element amounts to no more than general purpose computer components programmed to perform
the abstract idea and generally linking the use of an abstract idea to a particular technological environment or field of use.
Claim 1, directly or indirectly, recite the following generic computer components “a patient terminal for providing he patient with an ability to interact with the system;”, “one or more patient data collection devices coupled to the patient terminal”, “an adaptive knowledge engine configured to”, “a source document repository for storing peer reviewed texts and journals, health and clinical data, information and knowledge”, “an artificial intelligence analytics engine configured to utilize machine learning and natural language processing functions to…” are recited at a high degree of generality. As set forth in the MPEP 2106.05(f) "merely including instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claim recites “one or more patient problem-oriented health records including a data structure comprising: a top level problem view organized by health and care issues including a patient’s current and past chronic and acute problems; a detail level problem view for each chronic and acute problem organized by each step in a diagnostic, treatment and management process; a top level status view of the health and care issues; a detail level status view of each health and care issue; a detail level status view of the patient’s goals and care plans for each care and health issue; and a patient’s social and environmental health determinants as the patient’s social and environmental health determinants are continuously collected over time;” recites a health record, and amounts to no more than generally linking the abstract idea to a particular technological environment. As set forth in MPEP 2106.05(h), limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.
Claim 1: Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using generic computer components to perform the steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2016.05(h).
Claims 2-8, 10-11 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 2-5 further describe the views of the patient problem-oriented health records data structure. Similarly, claims 6-8 further define the social and environmental health determinants. Similarly, claim 10 further describes the source of the health and clinical data, and updating diagnostic treatment, and management options. Finally, claim 11 further describes the generic computer component of “the one or more patient data collection devices”. Therefore, these claims recite limitations that fall into the Mental Processes grouping of abstract ideas.
Dependent claims 2-8, 10-11 recite additional subject matter which amount to limitations consisted with the additional elements in independent claim 1 (such as claim 10 recites additional limitations that amount to invoking computers as a tool to perform the abstract idea.) Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of
elements improves the functioning of a computer or improves any other technology. Their
collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application. The claims are not
patent eligible.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being unpatentable over Soll et al. (U.S. Patent Pre-Grant Publication No. 2010/0198755).
As per independent claim 1, Soll discloses a system for providing a patient and members of their health team with an individualized health platform, comprising: a data, analytics, communication, guidance and documentation system (See Fig. 1 and Paragraphs [0120]-[0122]: The system employs one or more client-server computers, with all workstations accessing system programs and providing select services via the Internet or a local area network, which the Examiner is interpreting the system to encompass a data, analytics, communication, guidance and documentation system) including:
one or more patient problem-oriented health records including a data structure (See Paragraphs [0122]-[0123]: The CarePrep clinic system can utilize the communication server, to interconnect with the provider's central electronic medical record system to upload clinical reports or obtaining patient data, which the Examiner is interpreting CarePrep problem-oriented patient evaluation to encompass one or more patient problem-oriented health records including a data structure) comprising:
a top level problem view organized by health and care issues including a patient’s current and past chronic and acute problems (See Fig. 3 and Paragraphs [0125]-[0126], [0199]: The system queries patient information necessary for conducting the session and patient data, problem summaries, and concatenated reports are sent to the server, which the Examiner is interpreting patient data to encompass health and care issues, and problem summaries to encompass a patient’s current and past chronic and acute problems);
a detail level problem view for each chronic and acute problem organized by each step in a diagnostic, treatment and management process (See Table 4 and Paragraphs [0131]-[0133]: This initial triage obtains structured data regarding the principal reasons that bring the patient to clinic, thereby informing the system where to being asking more specific questions, and if a major problem is identified more detailed questions are presented to further define the symptoms or localize the pain, which the Examiner is interpreting the Problem-Oriented Access to Patient Information Data (Table 4) to encompass a detail level problem view for each chronic and acute problem organized by each step in a diagnostic, treatment and management process);
a top level status view of the health and care issues (See Paragraphs [0092]-[0093], [0199]: Clinicians use the clinician module to view a summary of patient data, access details, and provide their updates, impressions, and plan, which the Examiner is interpreting the clinician module to view a summary of patient data, access details to encompass a top level status view of the health and care issues);
a detail level status view of each health and care issue (See Table 4 and Paragraphs [0131]-[0133]: This initial triage obtains structured data regarding the principal reasons that bring the patient to clinic, thereby informing the system where to being asking more specific questions, and if a major problem is identified more detailed questions are presented to further define the symptoms or localize the pain, which the Examiner is interpreting the Problem-Oriented Access to Patient Information Data (Table 4) to encompass a detail level status view of each health and care issue ([0196]: Logic continues in FIG. 10, to complete the medical history with questions about general health status);
a detailed level status view of the patient’s goals and care plans for each care and health issue (See Table 4 and Paragraphs [0131]-[0133]: This initial triage obtains structured data regarding the principal reasons that bring the patient to clinic, thereby informing the system where to being asking more specific questions, and if a major problem is identified more detailed questions are presented to further define the symptoms or localize the pain, which the Examiner is interpreting the diagnostic and treatment plans (Table 4) to encompass a detail level status view of the patient’s goals and care plans for each care and health issue ([0196]: Logic continues in FIG. 10, to complete the medical history with questions about general health status); and
a patient’s social and environmental health determinants as the patient's social and environmental health determinants continuously collected over time (See Paragraphs [0196]-[0199]: The workstation display also includes the patient's questions, concerns, and expectations, past medical, family, and social history are also displayed, which the Examiner is interpreting the medical history is completed by using level of functioning and activities of daily living; health attitudes and expectations; preventive health activities including diet, weight control, and exercise; coping activities for stress; and problems with self-care to encompass a patient’s social and environmental health determinants, and interpreting alerts for this patient, the summary of symptom, psychosocial, behavioral, and quality of life issues, each of the relevant problems and the chief complaint to encompass continuously collected over time);
a patient terminal for providing the patient with an ability to interact with the system (See Paragraphs [0237]-[0246]: A preferred presentation engine (the player) runs in the corresponding patient carrel computer terminal, collects patient response data via script commands, screens, and inferences);
one or more patient data collection devices coupled to the patient terminal (See Paragraph [0112]: The invention provides practical tools to collect consistent, reliable data on patient assessment, patient outcomes, and clinician process);
an adaptive knowledge engine configured to automatically import health and clinical data for use in analyzing the one or more patient problem-oriented health records and assessing diagnostic, treatment, and management options, guidance, communication and documentation for the health and care issues (See Paragraphs [0113]-[0114]: The invention can query other electronic medical records systems to obtain other patient data, per patient costs and utilization of health care resources, which the Examiner is interpreting management algorithms ([0113]) to encompass an adaptive knowledge engine, and real-time adaptation of communication strategies, question sets, and management algorithms for patient characteristics to encompass automatically import health and clinical data for use in analyzing the one or more patient problem-oriented health records and assessing diagnostic, treatment, and management options, guidance, communication and documentation for the health and care issues), the adaptive knowledge engine comprising:
a source document repository for storing peer reviewed texts and journals, health and clinical data, information and knowledge (See Paragraph [0111]: The clinician module will also have the optional capability to import data from provider organization EMRs or other data repositories, such as laboratory result databases, relating to tests, procedures, medication lists, or other topics that can be displayed for clinicians using a consistent GUI in dedicated windows or problem-tagged so that these elements can appear in association with any given problem, which the Examiner is interpreting other data repositories, such as laboratory result databases, relating to tests, procedures, medication lists, or other topics to encompass a source document repository for storing peer reviewed texts and journals, health and clinical data, information and knowledge); and
an artificial intelligence analytics engine configured to utilize machine learning and natural language processing functions to analyze the peer reviewed texts and journals, health and clinical data, information and knowledge (See Paragraphs [0078]-[0079]: The specific components and the scoring algorithm for this complex case score will be determined empirically, based upon analyzing CarePrep data in combination with utilization of health care resources and assessment by clinicians, which the Examiner is interpreting the scoring algorithm to encompass an artificial intelligence analytics engine configured to utilize machine learning and natural language processing functions as the scoring algorithm analyzes CarePrep data in combination with utilization of health care resources and assessment by clinicians), and operate in a combinatorial manner by assessing care and health implications of patient data in the one or more problem-oriented health records, the peer-reviewed health texts and journals, health and clinical data, and data coming in from remote patient monitoring devices to provide updated diagnostic, treatment, and management options for each of the one or more patient problem-oriented health records (See Paragraph [0113]-[0115]: The modular design allows the accumulated knowledge in the database to be translated into continuous refinement of these algorithms, which the Examiner is interpreting the accumulated knowledge in the database to encompass assessing care and health implications of patient data in the one or more problem-oriented health records, the peer-reviewed health texts and journals, health and clinical data, and data coming in from remote patient monitoring devices to provide updated diagnostic, treatment, and management options for each of the one or more patient problem-oriented health records as the invention accommodates real-time adaptation of communication strategies, question sets, and management algorithms for patient characteristics, including age, gender, socioeconomic and educational background and medical history); and
a directory of community and virtual-based social services comprising vetted social service organizations for use by the patient in addressing one or more of the patient’s health and care issues and/or social and environmental health determinants (See Paragraphs [0219]-[0220]: The patient is given a printed health summary, including their problem list, clinician and follow-up instructions, personalized health education materials, and a reference on local resources, such as further instruction, counseling, support groups, websites, and hotlines, which the Examiner is interpreting counseling, support groups, websites, and hotlines to encompass a directory of community and virtual-based social services comprising vetted social service organizations.)
As per claim 2, Soll discloses the system of claim 1 as described above. Soll further teaches wherein the top level problem view is further organized by bodily systems (See Paragraphs [0262]-[0318]: Issues presented to clinician in the clinician module are presented by organs and organ systems.)
As per claim 3, Soll discloses the system of claim 1 as described above. Soll further teaches wherein the detail level problem view is organized in order of each step in a diagnostic and treatment and management process as a series of micro-care encounters arranged chronologically (See Paragraphs [0262], [0269], [0277]-[0294]: Management Recommendations are presented and different options for treatment are displayed, which the Examiner is interpreting to encompass the claimed portion ([0269]: Treatment guidelines regarding diagnostic testing and management are then displayed for each final problem for clinician selection).)
As per claim 4, Soll discloses the system of claim 1 as described above. Soll further teaches wherein the top level status view is further organized by active and inactive status by bodily systems (See Paragraphs [0096]-[0098]: All data elements used for gathering patient-entered data can be topic- or problem-tagged at content-authoring time, which the Examiner is interpreting gathering patient-entered data can be topic- or problem-tagged to encompass the top level status view is further organized by active and inactive status by bodily systems.)
As per claim 5, Soll discloses the system of claim 1 as described above. Soll further teaches wherein the detail level status view is organized by a status of a particular health and care issue (See Paragraphs [0222]: Several response options are offered including items such as new symptoms, change in status, concern or follow-up regarding a known problem, or routine visit, which the Examiner is interpreting a change in status to encompass organized by a status of a particular health and care issue.)
As per claim 6, Soll discloses the system of claim 1 as described above. Soll further teaches wherein the patient's social and environmental health determinants comprise main factors and driving factors for each main factor, the main factors comprising: healthcare factors, individual behavior factors, socio-economic factors, personal security issues, individual physiology factors, and environmental factors (See Paragraphs [0113], [0227]: Patient characteristics, including age, gender, socioeconomic and educational background and medical history, and changes in patient health behavior or life situation, or other factors, including psychosocial or stress elements ([0227]), which the Examiner is interpreting to encompass the main factors.)
As per claim 7, Soll discloses the system of claims 1 and 6 as described above. Soll further teaches wherein: the driving factors for the healthcare factors comprise improved early detection, prevention, and management of primary care for acute care and chronic diseases, end-of-life care, health information technology, and health care financing and incentives (See Paragraphs [0131]-[0133]: Patients are optionally questioned about other health care issues they want the clinician to review, which the Examiner is interpreting health care issues to encompass the claimed portion);
the driving factors for the individual behavior factors comprise character, intelligence, substance abuse, sleep patterns, nutrition, exercise, stress, social contacts, and social support (See Paragraphs [0193]-[0194]: Habits and substance use and abuse are screened for by the inventive system, which the Examiner is interpreting the psychosocial screening assessment to encompass the claimed portion); and
the driving factors for socio-economic factors comprise family situations; income, employment, neighborhood, housing, education, and services (See Paragraph [0113]: Patient characteristics including age, gender, socioeconomic and educational background and medical history, which the Examiner is interpreting to encompass the claimed portion.)
As per claim 8, Soll discloses the system of claims 1 and 6 as described above. Soll further teaches wherein: the driving factors for the personal security issues comprise the condition of the patient’s neighborhood and their housing, crime level, police protection, security, neighborhood watch organizations (See Paragraph [0113]: Patient characteristics including age, gender, socioeconomic and educational background and medical history, which the Examiner is interpreting to encompass the claimed portion);
the driving factors for the individual physiology factors comprise the patient’s genome, metabolome, physical and mental disabilities, and chronic illnesses (See Table 4 and Paragraph [0096]: Problem elements, such as symptoms, functional limitations, procedures, or operations that are related; or personal or family history of related conditions, which the Examiner is interpreting to encompass the claimed portion); and
the driving factors for the environmental factors comprise the patient’s neighborhood air and water quality, presence of toxic waste, and positive culture of the neighborhood (See Table 4 and Paragraph [0096]: Change in symptom pattern, compliance with medication, lifestyle measures, which the Examiner is interpreting the lifestyle measures to encompass the claimed portion.)
As per claim 10, Soll discloses the system of claim 1 as described above. Soll further teaches wherein the adaptive knowledge engine further comprises an adapter translator configured to perform validity checks on the imported health and clinical data (See Paragraph [0114]: Utilities will be provided to monitor data integrity, prevent duplicate records and safeguard data security and patient confidentiality, which the Examiner is interpreting prevent duplicate records and safeguard data security and patient confidentiality to encompass an adapter translator configured to perform validity checks on the imported health and clinical data.)
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Soll et al. (U.S. Patent Pre-Grant Publication No. 2010/0198755) in view of Ramgir (U.S. Patent Pre-Grant Publication No. 2018/0268109).
As per claim 11, Soll discloses the system of claim 1 as described above. Soll may not explicitly teach wherein the one or more patient data collection devices comprise a medication dispenser comprising circuitry that signals the adaptive knowledge engine when a medication has been dispensed.
Ramgir teaches a system wherein the one or more patient data collection devices comprise a medication dispenser comprising circuitry that signals the adaptive knowledge engine when a medication has been dispensed (See Paragraph [0123]: This version may be enabled to collect the body vitals, send to the doctor, and the doctor may prescribe the medicines, and it may include a medicine dispenser which may work based on doctor's prescription.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Soll to include the one or more patient data collection devices comprise a medication dispenser comprising circuitry that signals the adaptive knowledge engine when a medication has been dispensed as taught by Ramgir. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Soll with Ramgir with the motivation of that the database may contain virtually any data to improve the functionality of the medical kiosk services (See Ramgir of Detailed Description of Some Embodiments in Paragraph [0105]).
Response to Arguments
In the Remarks filed on December 23, 2025, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s), 35 U.S.C. 101 rejection(s), 35 U.S.C. 102 rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the previous Claim Objection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the newly added Claim Objection(s), 35 U.S.C. 101 rejection(s), 35 U.S.C. 102 rejection(s), and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) Applicant respectfully submits that the claims are not directed to a mental process because in general, it is not possible for the human mind to remember all of a patient's data in their problem-oriented health record, patient data coming into the AI analytics engine from patient data collection devices and wearables, and to identify and extract the relevant data from the thousands of peer reviewed articles and then conduct combinatorial analysis to generate guidance options on possible diagnoses, treatments and/or management approaches for a patient's particular acute or chronic issues. Applicant submits that the human mind is not capable of assembling a data structure as claimed. The human mind has no capability of automatically importing health and clinical data and utilizing machine learning and natural language processing functions to analyze peer reviewed texts and journals and provide updated diagnostic, treatment, and management options for each of one or more patient problem-oriented health records;
(2) Applicant respectfully submits that the claims involve more than routine or conventional activities. The claimed invention introduces an unconventional approach to providing a patient with an individualized health platform by implementing a specific data structure, enhanced by a problem-oriented health record, a knowledge repository, and an adaptive knowledge engine, to provide updated diagnostic, treatment, and management options for patient problem-oriented health records, and further includes a directory of community and virtual-based social services comprising vetted social service organizations for use by the patient in addressing the patient's social and environmental health determinants;
(3) Applicant respectfully submits that the claims include additional elements that amount to significantly more than the judicial exception The claimed invention provides specific improvements to computer functionality through the use of the adaptive knowledge engine. The adaptive knowledge engine provides concrete technical benefits by utilizing machine learning and natural language processing to analyze large amounts of peer reviewed texts and journals and use the resulting knowledge to update diagnostic, treatment, and management options for each of the one or more patient problem-oriented health records. The claimed invention provides a practical solution for a specific problem in providing healthcare. The present claims are specifically oriented to provide a system that employs artificial intelligence to analyze new data on a patient's changing health in the context of all the other data in that patient's health record and in the context of the relevant health/medical literature to produce refinement questions on the initial data on a new chronic/acute problem, and thus provide individualized and thus more accurate and precise guidance options, and the peer reviewed references and the patient's data in their problem-oriented health record - the combined data that is analyzed by the AI analytics engine to produce the guidance options. Therefore, Applicant respectfully submits that the claimed steps go beyond mental processes by involving processes and data structures that cannot be accomplished by the human mind. At least for these reasons, Applicant respectfully submits that, as amended, claim 1 is patentable under 35 U.S.C. §101. Claims 2-11 are patentable at least because of their dependencies and for the subject matter they recite;
(4) the present Action refers to Soll's Table 4 and paragraphs [0131]-[0133], however, Table 4 illustrates a patient symptom history organized by problem name with links to aspects of the particular problem, including diagnostic and treatment plans. However, the patient symptom history is organized by problem name, and not "by each step in a diagnostic, treatment and management process." Applicant respectfully submits that Soll also fails to disclose or suggest : one or more patient problem-oriented health records including a data structure comprising: a patient's social and environmental health determinants as they are continuously collected over time. The present Action refers to Soll's paragraphs [0196] and [0199] which also refer to Soll's Table 4. However, Soll only refers to a patient's questions, concerns, expectations, and past medical, family, and social history, collected once and organized as part of a record as shown in Table 4, structured by individual problems, as opposed to a detail level problem view for each chronic and acute problem organized by each step in a diagnostic, treatment and management process including "a patient's social and environmental health determinants as they are continuously collected over time" and applied to the solution of each of a patient's care and health problems Applicant respectfully submits that Soll also fails to disclose or suggest: one or more patient problem-oriented health records including a data structure comprising: a patient's social and environmental health determinants as they are continuously collected over time. The present Action refers to Soll's paragraphs [0196] and [0199] which also refer to Soll's Table 4. However, Soll only refers to a patient's questions, concerns, expectations, and past medical, family, and social history, collected once and organized as part of a record as shown in Table 4, structured by individual problems, as opposed to a detail level problem view for each chronic and acute problem organized by each step in a diagnostic, treatment and management process including "a patient's social and environmental health determinants as they are continuously collected over time" and applied to the solution of each of a patient's care and health problems;
(5) Soll describes a database (see [0113]-[0l 14]) which captures raw patient data including initial clinical assessment, quality of life and response to therapy, provisional problems, patient verification of identified patterns, clinician process, including observations, impressions and treatment, clinical impressions and diagnoses, and long-term follow-up. Soll may utilize standard communication protocols to query other electronic medical records systems to obtain other patient data, per patient costs and utilization of health care resources, laboratory data, consultations, surgeries, and pathology, however Soll is silent with respect to an adaptive knowledge engine comprising a source document repository and an artificial intelligence analytics engine as claimed. The present Action refers to Stall's paragraph [0220] which only discloses a reference on local resources, such as further instruction, counseling, Support groups, websites, and hotlines, as opposed to a directory of community and virtual-based social services comprising vetted social service organizations;
(6) claim 11 is rejected under 35 U.S.C. §103 as being unpatentable over Soll in view of Ramgir (US 2018/0268109). Claim 11 depends from claim 1. Ramgir fails to disclose or suggest all the features of claim 1 missing from Soll and as a result, the combination of Ramgir and Soll fails to render claim 11 unpatentable.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the limitations, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass using a computer as a tool to perform a mental process, which is a subgrouping of Mental Processes. The Examiner maintains that a person could execute the limitations, as drafted, by using a computer as a tool. The Examiner maintains that the “data structure” recites a health record, and amounts to no more than generally linking the abstract idea to a particular technological environment. As set forth in MPEP 2106.05(h), limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application. The Examiner maintains that a person using a computer as a tool could automatically importing health and clinical data and utilizing machine learning and natural language processing functions to analyze peer reviewed texts and journals and provide updated diagnostic, treatment, and management options for each of one or more patient problem-oriented health records. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the judicial exception is not integrated into a practical application because the remaining element amounts to no more than general purpose computer components programmed to perform the abstract idea and generally linking the use of an abstract idea to a particular technological environment or field of use. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The Examiner does not acknowledge that the Applicant’s claims provide a clear improvement as the Applicant’s claims are similar to “iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48” (See MPEP 2106.05(a)(II)) which the courts have indicated may not be sufficient to show an improvement to technology. The Examiner maintains that claims 1-11 are rejected under 35 U.S.C. 101. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (4), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Soll teaches organization “by each step in a diagnostic, treatment and management process” as Paragraphs [0131]-[0133] disclose that the initial triage obtains structured data regarding the principal reasons that bring the patient to clinic, thereby informing the system where to being asking more specific questions, and if a major problem is identified more detailed questions are presented to further define the symptoms or localize the pain. The Examiner maintains that Soll teaches “one or more patient problem-oriented health records including a data structure comprising: a patient's social and environmental health determinants as they are continuously collected over time” as Soll discloses in Paragraphs [0196]-[0199] that the workstation display also includes the patient's questions, concerns, and expectations, past medical, family, and social history are also displayed, which the Examiner is interpreting the medical history is completed by using level of functioning and activities of daily living; health attitudes and expectations; preventive health activities including diet, weight control, and exercise; coping activities for stress; and problems with self-care to encompass a patient’s social and environmental health determinants, and interpreting alerts for this patient, the summary of symptom, psychosocial, behavioral, and quality of life issues, each of the relevant problems and the chief complaint to encompass continuously collected over time. The 35 U.S.C. 102 rejection(s) stand.
In response to argument (5), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Soll teaches “31. an adaptive knowledge engine configured to automatically import health and clinical data for use in analyzing the one or more patient problem-oriented health records and assessing diagnostic, treatment, and management options, guidance, communication and documentation for the health and care issues” in Paragraphs [0113]-[0114] as invention can query other electronic medical records systems to obtain other patient data, per patient costs and utilization of health care resources, which the Examiner is interpreting management algorithms ([0113]) to encompass an adaptive knowledge engine, and real-time adaptation of communication strategies, question sets, and management algorithms for patient characteristics to encompass automatically import health and clinical data for use in analyzing the one or more patient problem-oriented health records and assessing diagnostic, treatment, and management options, guidance, communication and documentation for the health and care issues. The Examiner maintains that Soll teaches “a source document repository for storing peer reviewed texts and journals, health and clinical data, information and knowledge” in Paragraph [0111] that the clinician module will also have the optional capability to import data from provider organization EMRs or other data repositories, such as laboratory result databases, relating to tests, procedures, medication lists, or other topics that can be displayed for clinicians using a consistent GUI in dedicated windows or problem-tagged so that these elements can appear in association with any given problem, which the Examiner is interpreting other data repositories, such as laboratory result databases, relating to tests, procedures, medication lists, or other topics to encompass a source document repository for storing peer reviewed texts and journals, health and clinical data, information and knowledge. The Examiner maintains that Soll’s disclosure in Paragraph [0220] “Finally, the patient is given a printed health summary, including their problem list, clinician and follow-up instructions, personalized health education materials, and a reference on local resources, such as further instruction, counseling, support groups, websites, and hotlines.” encompasses “a directory of community and virtual-based social services comprising vetted social service organizations” as Paragraphs [0202]-[0206] describes management options for the patient including “other referrals, for example, for nutritional assessment, psychosocial/psychological, stress assessment and intervention, or somatic therapy”, and the Examiner is interpreting that “psychosocial/psychological referrals” would require at least a level of vetting to be an option to be displayed to a doctor to be used as a referral. The 35 U.S.C. 102 rejection(s) stand.
In response to argument (6), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the combination of Soll in view of Ramgir (US 2018/0268109) encompass claim 11. The 35 U.S.C. 103 rejection(s) stand.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683