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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 28, 2025 has been entered.
Response to Amendment
This Non-FINAL office action is in response to the claims filed on July 28, 2025.
Claims 1, 18, and 21 have been amended.
Claims 1-23 are currently pending and have been examined.
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 1-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Eligibility Step 1 (Does the subject matter fall within a statutory category?)
Claims 1-20 are both drawn to a system, and claims 21-23 are drawn to a method, both of which are within the four statutory categories.
Eligibility Step 2A-1 (Does the claim recite an abstract idea, law of nature, or natural phenomenon?)
Claims 1-23 are further directed to an abstract idea on the grounds set out in detail below:
The Examiner has identified independent method claim 21 as the claim that represents the claimed invention for analysis and is similar to independent claim 1.
Claims 1 and 21 recites a series of steps/functions for constructing a consultation note based on patient information, which, under the broadest reasonable interpretation, is an abstract idea that falls within the “Certain Method of Organizing Human Activity” grouping of abstract ideas such as managing behavior or relationships or interactions between people (i.e., following a set of rules or instructions).
Claim 21 (which is also representative of Claim 1) recites the following limitations which set forth the abstract idea:
receiving a request […] to schedule a medical appointment with a physician,
transmitting, […], an active sheet to the patient device after receiving the request, the active sheet including an electronic medical questionnaire form having data fields that prompt a patient to select symptoms from among a plurality of symptoms, the active sheet including embedded logic configured to:
select detailed medical questions based on the selection of symptoms, the detailed medical questions corresponding to one or more possible disease conditions,
prompt the patient with the detailed medical questions, and
determine tests or medical documentation needed for a consultation with a physician; and
receiving, […], patient data […] via the active sheet, the patient data including a selection of symptoms and answers to the detailed medical questions,
receiving, […], medical documentation […] via the active sheet;
identifying and extracting, […], relevant medical information including text and images from the medical documentation, the medical information comprising a subset of the medical documentation and including at least one of test results, medical images, clinician notes, prior treatments, or medical history information,
generating automatically, […], a clinical consultation note using the extracted relevant medical information and at least some of the patient data from the active sheet, and
transmitting, […], the clinical consultation note […] for the medical appointment with the patient.
Eligibility Step 2A-2 (Does the claim recite additional elements that integrate the judicial exception into a practical application?):
This judicial exception is not integrated into a practical application.
Claims 1 and 21 recite the following additional elements:
A memory device
A server communicatively coupled to the memory device
A patient device
A physician device
Executing the embedded logic by the patient device;
using at least one of keyword matching, optical character recognition (“OCR”), or image analysis
The memory device, server elements, patient and physician devices are recited a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Using keyword matching, OCR, and image analysis and executing embedded logic by a device are existing well known processes that are applying the abstract idea. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claims 1 and 21 are directed to an abstract idea without a practical application.
The use of additional elements noted above as tools to implement/automate the abstract idea does not render claims 1 and 21 to be patent eligible because it does not provide meaningful limitations and requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea.
Eligibility Step 2B (Does the claim amount to significantly more?):
Claims 1 and 21 do not include additional elements that are sufficient to amount to significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements noted above to perform the generic computer functions amount to no more than mere instructions to apply the abstract idea using a generic computer component or generally link the claimed invention to a particular technological environment or field of use (see MPEP 2106.05 (I)(A)). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Claims 1 and 21 are, therefore, not patent eligible.
The dependent claims 2-20 and 22-23 further define the abstract idea that is present in their respective independent claims and hence are abstract for at least the reasons presented above.
Dependent claims 2-5 and 7-20 do not recite additional elements other than those in their respective independent claims.
Dependent claims 6, 12-13, 17, 18 recite the following additional elements:
An application configured as the active sheet (claim 6)
One or more application programming interfaces (claim 6)
Embedded links (claims 12-13)
Peripheral device that is communicatively coupled to the patient device, including at least one of a fitness tracker, a smartwatch, a smart ring, a wireless weight scale, or a blood pressure cuff (claim 17)
A timer system (claim 18)
The noted above additional elements are recited a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claims 6, 12-13, 17 and 18 are directed to an abstract idea without a practical application.
The dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the dependent claims are directed to an abstract idea. Claims 2-20 and 22-23 are, therefore, not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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, 3-10, 19, 21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, and further in view of Owen et al. (US 20220208322 A1), hereinafter Owen.
Regarding claim 1, Van De Steen teaches a system for automatically pre-constructing a clinical consultation note during a patient intake/admission process (medical consultation support tool), the system comprising:
a memory device storing an active sheet including a medical questionnaire form having data fields that prompt a patient to select symptoms from among a plurality of symptoms (Van De Steen [0086] discloses a memory), the active sheet including embedded logic configured to: select detailed medical questions based on the selection of symptoms, the detailed medical questions corresponding to one or more possible disease conditions (Van De Steel [0007]-[0013] disclose an electronic patient portal that obtains pre-consultation complaint description and a differential diagnosis module that matches the complaint to symptoms/arguments. [0018] discloses the portal presents additional questions to the patient based on their initial symptom entry with the questions correlated to potential diagnoses); and
prompt the patient with the detailed medical questions ([0018] discloses the portal presents additional questions to the patient based on their initial symptom entry with the questions correlated to potential diagnoses), and
a server communicatively coupled to the memory device (Van De Steen [0071] discloses a server), the server configured to:
receive a request from a patient device to schedule a medical appointment with a physician (Van De Steen [0072] discloses the pre-consultation patient portal enables the patient to schedule an appointment through the appointment scheduler),
transmit the active sheet […] to the patient device after receiving the request (Van De Steen [0074] discloses the pre-consultation portal is configured to interrogate the patient with respect to their symptoms/complaints as shown in Fig. 5. The symptoms can be selected from a dropbox/list, by entering free text, or through speech input.),
receive patient data from the patient device via the active sheet, the patient data including a selection of symptoms and answers to the detailed medical questions (Van De Steen [0074] discloses the patient enters their symptoms in the pre-consultation patient portal. [0077] discloses the differential diagnosis module matches the symptoms to arguments in the database and generates additional questions on symptoms that are correlated with a potential diagnoses.),
identify and extract relevant medical information including text and images from the medical documentation using at least one of keyword matching, optical character recognition (“OCR”), or image analysis, the medical information comprising a subset of the medical documentation and including at least one of test results, medical images, clinician notes, prior treatments, or medical history information (Van De Steen [0038] discloses a NLP that recognizes words, terms, from patient’s pre-consultation complaint description. [0038] also discloses an image processor that processes images delivered by the patient to identify and/or quantify certain symptoms) (The Examiner notes that the claims do not describe how information is identified to be relevant).
generate automatically a clinical consultation [item] using the extracted relevant medical information and at least some of the patient data from the active sheet (Van De Steen [0080] discloses the clinician portal generates a screen containing the pre-consultation information received from the patient with multiple fields for the patient’s personal details, initial complaints, answers to questions, fields for the clinician to enter symptoms and/or confirm diagnosis), and
transmit the [clinical consultation item] to a physician device for the medical appointment with the patient (Van De Steen [0080] discloses a screen containing pre-consultation information and fields for data entry through a clinical portal).
Van De Steen may not explicitly teach the following limitations; however, Huyn teaches:
execution of the embedded logic in the active sheet by the patient device (Huyn [0037] discloses a computer-assisted medical questionnaire for obtaining clinical data directly from patients, where the presented questions are selected dynamically as the subject responds to questions, and the conditions determining which questions are selected can themselves be updated without having to change the questionnaire software significantly. [0044] discloses an entire questionnaire is implemented on a single computer having sufficient memory, processing capabilities, and input and out capabilities (interpreted as the patient device) as shown in Fig. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the consultation support system of Van De Steen to include a questionnaire with embedded logic executed on a device as taught by Huyn in order to collect patient data.
Van De Steen/Huyn may not explicitly teach the following limitations; however, Iliff teaches:
determine tests or medical documentation needed for a consultation with a physician (Iliff [0051] discloses recommending appropriate tests for the patient); and
receive medical documentation provided by the patient device via the active sheet (Iliff [0036] discloses obtaining information from patients through an interview where the patient provides the system with answers to questions regarding symptoms. Symptoms can be defined as a piece of historical information, piece of information from a physical examination,…results of a lab test or imaging. [0042] discloses a user computer or other devices for provided answers to the medical interview.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the consultation support system of Van De Steen/Huyn to include receiving medical documentation and extracting information from the documentation as taught by Iliff in order to provide medical professionals with complete and accurate medical information about the patient.
Van De Steen/Huyn/Iliff/ do not explicitly teach the following limitations; however, Owen teaches:
generate automatically a clinical consultation note by incorporating the extracted relevant medical information and at least some of the patient data from the active sheet (Owen [0010]-[0011] discloses a computing system that prompts a patient to provide encounter information via a virtual assistant during a previsit portion of a patient encounter. The encounter information is processed to populate at least a portion of a medical record associated with the patient encounter (interpreted as a clinical consultation note).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the medical system of Van De Steen/Huyn/Iliff to include automatically constructing a clinical note as taught by Owen in order to provide medical professionals with more efficient clinical documentation.
Regarding claim 3, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1, wherein the active sheet is configured to prompt a patient for additional patient data including at least one of past medical history, past surgical history, current/past medications, current/past allergies, family and social history, history of present illness, or general activity level (Van De Steen [0071] discloses the patient sequentially enters general health information such as information on allergies, medication, vaccinations, sports frequency, illness history, family history, etc.). (Iliff [0009] discloses questions to the patient that elicit symptoms from the patient. [0036] discloses the MDATA system conducts interviews of patients using a database of medical diagnostic scripts. Symptoms can be defined as historical information, etc.).
Regarding claim 4, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1, wherein the server is further configured to select the detailed medical questions embedded within the active sheet also using the additional medical information (Van De Steen [0077]-[0078] discloses generating questions on symptoms based on patient complaints. Plural rounds of additional questions are generated and raised to the patient.) (Iliff [0009] discloses each question to the patient generates one of a set of defined responses and each responses generates one of a set of defined questions. The responses to the questions lead to more questions. [0168] discloses dynamically altering the question stream based on the patient’s health state).
Regarding claim 5, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1, wherein the test or medical documentation includes at least one of x-rays, patient fluid laboratory results, blood test laboratory results, computed tomography ("CT") images and/or reports, magnetic resonance imaging ("MRI") images and/or reports, ultrasound images and/or reports, previous clinical notes, or an electronic medical record ("EMR") (Iliff [0051] discloses an evaluation process that accesses a lab test of choice and imaging modality of choice database to recommend the appropriate tests. [0052] discloses a medical history database. [0173] discloses the engine opens the patient record to obtain the patient’s medical history and results of past sessions).
Regarding claim 6, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1, wherein the patient device includes an application configured as the active sheet, the application configured to receive the patient data from the patient and transmit the patient data to the server via one or more application programming interfaces (Van De Steen [0071] discloses the pre-consultation patient portal is a software module running with the patient on a client computer or on a remote server made accessible to the patient through a connected device and enables the patient to enter their information).
Regarding claim 7, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1, wherein the clinical consultation note includes sections for a review of patient symptoms, identification of a referring physician, identification of a pharmacy, laboratory results, medical images, prior clinical notes, a diagnosis/assessment to be completed by the physician, a principal plan to the completed by the physician, additional tests to be completed or selected by the physician, a discussion of risks benefits to be completed by the physician, an impression of medical condition, or action items to be completed (Van De Steen [0080] discloses the clinician portal generates a screen containing fields with the pre-consultation information from the patient such as patient complaints, a field wherein the clinician enters additional symptoms seen during the consultation, a fields with the differential diagnosis displayed, etc.). (Owen [0073] discloses the encounter transcript/medical record may be reviewed by a medical professional involved with the patient encounter to determine accuracy/make corrections. [0110]-[0111] discloses the automated clinical documentation process initiates an inquiry to the medical professional concerning a potential medical situation. Example of the inquiry may include substituting medications or asking if the patient has diabetes.).
Regarding claim 8, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 7, wherein the server is configured to:
receive the clinical consultation note from the physician device with sections completed by the physician and at least one action item selection (Van De Steen [0080] discloses the clinician enters additional symptoms during the consultation and select via a drop down box his confirmation of the suggested diagnosis and his confidence in it); and
store the clinical consultation note to a medical record associated with the patient (Owen [0038] discloses processing clinical encounter information to generate/store/distribute medical records).
Regarding claim 9, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 7, wherein the server is further configured to cause a medical system to perform the at least one action item selected (Van De Steen [0081] discloses the system may adapt the differential diagnosis as a result of new symptoms entered/confirmed diagnosis by the clinician).
Regarding claim 10, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 7, wherein the at least one action item includes at least one of a medication order, a request to send the clinical consultation note to another physician, an order for a laboratory test, a schedule for a next appointment, a request to send standardized written materials related to a medical condition to the patient device, or a request to submit a bill (Owen [0110] discloses that the doctor prescribed medication X. Owen [0111] discloses the automated process inquires if the doctor would like to substitute a prescribed medication).
Regarding claim 19, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1, wherein the server is further configured to:
receive a second request from the patient device to schedule a subsequent medical appointment with the physician (Van De Steen (0049]-[0050] disclose the patient can schedule an appointment with a clinician using the appointment scheduler and indicates the type of appointment as new complaint, vaccination, prescription, delivery of sample, etc. (which are interpreted as subsequent appointments); and
use at least some of the patient data to pre-construct the active sheet (Van De Steen [0080] discloses the clinician portal generates a screen where the patient’s personal details and type of consultation are displayed) .
Regarding claim 21, Van De Steen teaches a method for automatically pre-constructing a clinical consultation note during a patient intake/admission process ([0055] discloses a method for medical consultation support),
The claim limitations are analogous to the limitations in claim 1. As such, claim 21 is rejected for the same reasons given for claim 1.
Regarding claim 23,
The claim limitations are analogous to the limitations in claim 7 and 8. As such, claim 23 is rejected for the same reasons given for claims 7 and 8.
Claim(s) 2, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, in view of Owen et al. (US 20220208322 A1), hereinafter Owen, and further in view of Ballard et al. (US 20210057064 A1), hereinafter Ballard.
Regarding claim 2, Van De Steen/Huyn/Iliff/ Owen teach the system of claim 1, wherein the server is further configured to:
extract relevant medical information from the third-party medical documentation for inclusion within the clinical consultation note (Van De Steen [0076] discloses symptoms extracted from the personal health record of the patient).
Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Ballard teaches
receive, via the active sheet, information indicative of another medical provider ([0010 discloses a second medical provider);
transmit a request for third-party medical documentation to the other medical provider ([0066] discloses transmitting a prior medical record query to external medical providers);
receive the third-party medical documentation from the other medical provider ([0074]-[0075] disclose the virtual machine retrieves prior medical records and transfers them from an external medical provider to the requesting medical provider).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the consultation support system as taught by Van De Steen/Huyn/Iliff/Owen to include receiving medication documentation from other providers as taught by Ballard in order to “facilitate the preservation of the continuum of care and allow medical records to automatically be obtained ahead of scheduled appointments or procedures” (Ballard, Abstract).
Regarding claim 20, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Ballard teaches wherein the server is further configured to receive additional medical documentation from a remote electronic medical record system via interoperability (Ballard ([0074]-[0075] disclose the virtual machine retrieves prior medical records and transfers them from an external medical provider to the requesting medical provider).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the consultation support system as taught by Van De Steen/Huyn/Iliff/Owen to include receiving medication documentation from other providers as taught by Ballard in order to “facilitate the preservation of the continuum of care and allow medical records to automatically be obtained ahead of scheduled appointments or procedures” (Ballard, Abstract).
Regarding claim 22,
The claim limitations are analogous to the limitations in claim 2. As such, claim 22 is rejected for the same reasons given for claim 2.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, in view of Owen et al. (US 20220208322 A1), hereinafter Owen, and further in view of Inoue (JP 2016181310A).
Regarding claim 11, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 7. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Inoue teaches wherein the server is further configured to:
cause at least some of the sections of the clinical consultation note to be colored coded ([0006] discloses an electronic medical record device with a display control that assigns a color to the sections that need to be completed); and
remove or change the color coding after detecting or receiving an indication that the section was selected or reviewed by the physician ([0006] discloses as the medical record is edited, the display form/color for each field changes to recognize the progress of the changes made).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the system of constructing a clinical consultation note as taught by Van De Steen/Huyn/Iliff/Owen to include color coding sections of the note as taught by Inoue in order to track progress of the note and ensure accuracy and completion.
The Examiner notes that changing colors to indicate something represents non-functional descriptive information the is obvious in view of Steen/Huyn/Iliff /Owen; however, Inoue has been cited for completeness.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, in view of Owen et al. (US 20220208322 A1), hereinafter Owen, and further in view of Dussia (US 7464043 B1).
Regarding claim 12, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Dussia teaches:
wherein the server is further configured to generate automatically the clinical consultation note by embedding at least some links in the clinical consultation note to the related extracted relevant medical information, wherein selection of an embedded link causes the related extracted relevant medical information to be displayed in conjunction with the clinical consultation note (Dussia [Col. 8, lines 16-34] discloses as shown in FIG. 3, database may be populated with respective progress notes resulting from further encounters between the respective patient and any respective physician treating the patient so as to create a searchable historical set of progress notes for that respective patient. As suggested above, the set of historical notes is logically interconnectable based on one or more logic operators. As shown in FIG. 3, a list of diagnosis including a respective set of hyperlinks 72 each indicative of a respective diagnosis date is provided to enable a respective user to download and review the respective progress note associated with any given diagnosis date. Similarly, a set of hyperlinks 74 may be listed in a desired chronological order to enable the user to monitor progress of a given pathological condition in the patient. FIG. 3 further shows a list of prescriptions including a respective set of hyperlinks 76 each indicative of a respective prescription date that allows the user for logically connecting respective progress notes and prescription dates.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify automatically generating the clinical consultation note as taught by Van De Steen/Huyn/Iliff/Owen to include embedded links to more information as taught by Dussia in order to allow for easy access to the patient’s information and allow the user to monitor the progress of the patient’s condition.
Regarding claim 13, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Dussia teaches:
wherein the server is further configured to generate automatically the clinical consultation note by embedding at least some links in the clinical consultation note to the at least some of the patient data from the active sheet (Dussia [Col. 8, lines 16-34] discloses As shown in FIG. 3, database 16 may be populated with respective progress notes resulting from further encounters between the respective patient and any respective physician treating the patient so as to create a searchable historical set of progress notes for that respective patient. As suggested above, the set of historical notes is logically interconnectable based on one or more logic operators. As shown in FIG. 3, a list of diagnosis including a respective set of hyperlinks 72 each indicative of a respective diagnosis date is provided to enable a respective user to download and review the respective progress note associated with any given diagnosis date. Similarly, a set of hyperlinks 74 may be listed in a desired chronological order to enable the user to monitor progress of a given pathological condition in the patient. FIG. 3 further shows a list of prescriptions including a respective set of hyperlinks 76 each indicative of a respective prescription date that allows the user for logically connecting respective progress notes and prescription dates.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify automatically generating the clinical consultation note as taught by Van De Steen/Huyn/Iliff/Owen to include embedded links to more information as taught by Dussia in order to allow for easy access to the patient’s information and allow the user to monitor the progress of the patient’s condition.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, in view of Owen et al. (US 20220208322 A1), hereinafter Owen, and further in view of Welling et al. (US 20110258195 A1), hereinafter Welling.
Regarding claim 14, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Welling teaches:
wherein the server is further configured to extract the relevant medical information from the medical documentation by performing one or more of the following functions: denoise the medical documentation, find number patches in the medical documentation, cut patches from the medical documentation, identify a denoised image in the medical documentation, remove isolated parts of the medical documentation, crop redundant or unneeded parts of the medical documentation, add a boundary to the medical documentation, or extract features from the medical documentation (Welling [0130] discloses an image feature extraction system that removes noise from document images).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the extracting medication information as taught by Van De Steen/Huyn/Iliff/Owen to include extracting features and denoising as taught by Welling in order to accurately and efficiently enter data into a digital format (Welling, [0022]).
Regarding claim 15, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Welling teaches: wherein the server is further configured to extract the relevant medical information from the medical documentation by performing one or more of the following functions: remove black boxes, remove a table border, remove dots, or de-skew at least portions of the medical documentation (Welling [0130] discloses an image feature extraction system that removes noise in the form of dots, specks, and blobs from document images).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the extracting medication information as taught by Van De Steen/Huyn/Iliff/Owen to include extracting features and denoising as taught by Welling in order to accurately and efficiently enter data into a digital format (Welling, [0022]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, in view of Owen et al. (US 20220208322 A1), hereinafter Owen, and further in view of Wang et al. (US 20230206675 A1), hereinafter Wang.
Regarding claim 16, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Wang teaches: wherein the server is further configured to extract the relevant medical information from the medical documentation by modifying words and punctuation by deleting non-sense words, correcting spelling, or correcting punctuation (Wang [0043] discloses an information extraction engine that includes text normalization including removing stop words).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the extraction of information as taught by Van De Steen/Huyn/Iliff/Owen to include modifying words and punctuation as taught by Wang in order to accurately extract data by transforming the data into a standard and consistent form free of errors.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, in view of Owen et al. (US 20220208322 A1), hereinafter Owen, and further in view of Weinstein et al. (US 20170161451 A1), hereinafter Weinstein.
Regarding claim 17, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Weinstein teaches: wherein at least some of the patient data is provided by a peripheral device that is communicatively coupled to the patient device, the peripheral device including at least one of a fitness tracker, a smartwatch, a smart-ring, a wireless weight scale, or a blood pressure cuff (Weinstein [0116] discloses aggregation of signal sensors and electronic health records into an algorithm through an individual smart device or hardware hub. The sensors include one or more devices connected to the patient to measure physiological status of the patient such as a weight scale, blood pressure cuff, glucometer, activity tracker, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the data input method as taught by Van De Steen/Huyn/Iliff/Owen to include receiving data directly from peripheral devices as taught by Weinstein in order to provide clinical data for proper diagnosis and treatment (Weinstein, [0002]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Steen et al. (US 20190295719 A1), hereinafter Van De Steen, in view of Huyn et al. (US20020035486A1), hereinafter Huyn, in view of Iliff et al. (US20080052318A1), hereinafter Iliff, in view of Owen et al. (US 20220208322 A1), hereinafter Owen, and further in view of Findlay et al. (US 20100299155 A1), hereinafter Findlay.
Regarding claim 18, Van De Steen/Huyn/Iliff/Owen teach the system of Claim 1. Van De Steen/Huyn/Iliff/Owen do not explicitly teach the following limitations; however, Findlay teaches: wherein the server is further configured to:
use a timer system to determine an aggregate time spent a) pre-visit filling out the active sheet, b) intra-visit during the actual medical appointment with the patient, and c) post-visit spent completing the clinical consultation note; and cause a bill to be generated based on the aggregate time (Findlay [0029] discloses… the billing module may be used to, among other things, view billing information (such as itemized listing of services—such as per message, per web-chat, per office visit, etc., and their fees) [0036] discloses by using a fee rate billing factor, a fee may be calculated according to a billing factor based on the amount of time the doctor spends interacting with or otherwise performing a medical service on the patient.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the medical system as taught by Van De Steen/Huyn/Iliff/Owen to include a timer system that tracks the time performing medical services and generating a bill as taught by Findlay in order to automate the billing process and making it more efficient.
Response to Arguments
35 U.S.C 112 Rejection of Claim 18
Regarding the 112(b) rejection of claim 18, Applicant has amended the claim by removing “on behalf of the patient”. As such, the indefiniteness rejection has been withdrawn.
35 U.S.C 101 Rejection of Claims 1-23
Regarding the 101 rejection of claims 1-23, the Examiner finds Applicant’s arguments unpersuasive and maintains the 101 rejection.
Applicant argues: The Office Action rejected Claims 1-23 under 35 U.S.C. § 101 as being allegedly directed towards the "certain methods of organizing human activity" grouping of the judicial exceptions set forth in the MPEP. Applicant hereby amends claims 1 and 21 to recite "prompt the patient with the detailed medical questions,", support for which can be found in at least Paragraphs [0006], [0007], [0068], [0120], [0122], [0144], and the Abstract. Applicant respectfully submits that the alleged judicial exception is integrated into a practical application. The claims as amended are directed towards systems and methods which autonomously determine which medical questions are most relevant to a patient's situation and to acquire the patient's answers to these questions, without the need for a physician's intervention. The claims are drawn to a specific and unconventional system architecture in which the patient's device handles the majority of the processing for the questionnaire without the need for continuous communication with the server. See Paragraph [0072] of the instant specification: "A processor of the patient device is configured to execute the one or more instructions to execute the active sheet questionnaire". See also Paragraph [0112] of the instant specification: "The example active sheet questionnaire includes a logic or algorithm driven, digital, detailed patient-intake form that is completed by a patient using the application on the patient device". While some generic computing components may be employed in constructing this system architecture, the unconventional usage of these components represents an inventive concept amounting to significantly more than any judicial exception pursuant to MPEP 2106.05(I)(A). Systems and methods of the instant disclosure also advantageously reduce network traffic and processing demand on healthcare provider systems by executing questionnaire logic on the patient's device, thereby reducing overall computational resource usage in satisfaction of MPEP 2106.05(a) (Improved functioning of a computer). Conventional systems (including the primary reference cited in the 35 U.S.C. 103 rejection addressed below) rely on a litany of back-and-forth server queries and responses to accomplish patient data gathering. This generates significant network traffic and places a great deal of processing demand upon the server-side systems which have to both respond to queries and execute logic which determines what page to send the client (patient) next. By shifting runtime decision making to the client device via embedded logic in the active sheet, a reduction in infrastructure demand can be achieved allowing for many more patient devices to interact with a same server infrastructure. See Paragraph [0068] of the instant disclosure: "The active sheet questionnaires include embedded logic or rules that specify more detailed medical questions based on initial patient data provided by a patient." See also Paragraph [0114] of the instant disclosure: “The active sheet questionnaire includes embedded logic or algorithms that search for and identify keywords within the patient data input by a patient (e.g., chief complaint, history of present illness, review of systems, medications, past medical/surgical history, etc.)." Those of skill in the art will easily and quickly understand from the instant disclosure that, using the instant disclosure's techniques, as few as two request-response interactions may be executed to gather a full visit's worth of patient data, which represents an exponential reduction when compared to conventional techniques. Applicant thus respectfully submits that the claims as amended are directed to a technological solution to a technological problem which improves the functioning of a computer pursuant to MPEP 2106.05(a) and which amounts to significantly more than the alleged judicial exception pursuant to MPEP 2106.05(I)(A). Applicant therefore respectfully requests that the subject matter-eligibility rejections be withdrawn.
The Examiner respectfully disagrees. The questionnaire with an embedded logic/algorithm running on the patient device is not unconventional and Applicant has not provided evidence showing this architecture to be unconventional. As cited in Huyn in claim 1, the questionnaire can be a dynamic questionnaire with logic that operates on one computer without the need to communicate with a server. Additionally, neither the claims or the Specification describe how executing questionnaire logic reduces network traffic and processing demands on healthcare provider systems. Furthermore, prompting a patient with the detailed medical questions is just a form of collecting data, which according to the MPEP 2106.05(g) amounts to insignificant extra solution activity. As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978).
35 U.S.C 103 Rejection of Claims 1-23
Regarding the prior art rejection of claims 1 and 21,
Applicant argues: The Office Action asserts on page 8 that the "patient portal" of Van De Steen teaches the active sheet of the present claims. Applicant respectfully disagrees. Per the Office Action's admissions on page 8, § 27(c), the "patient portal" of Van De Steen enables the patient, via the appointment scheduler, to schedule an appointment. Indeed, this is listed as allegedly teaching the "receive a request from a patient device to schedule a medical appointment" recited by Claim 1. Also on page 8, in § 27(d), the Office Action alleges that the "patient portal" of Van De Steen teaches the "transmit the active sheet to the patient device after receiving the request" (emphasis added) recited by Claim 1. The issue here is that the "patient portal" of Van De Steen is both used to submit the scheduling request and is also transmitted to the patient device after receiving the request. This contradiction is explained by an investigation of the system of Van De Steen, which does not, in fact, transmit the "patient portal" after receiving the request, but rather does so before receiving the request. Applicant therefore submits that Van De Steen fails to teach or suggest "transmit the active sheet to the patient device after receiving the request" as recited by Claim 1 and similarly recited by Claim 21.
The Examiner respectfully disagrees. Van De Steen [0072] discloses “when the patient has a complaint, he/she can schedule an appointment through the appointment scheduler that forms part of the medical consultation support tool. Figure 3 displays an interface that allows the user to schedule and appointment and select continue. Following the appointment request, the portal (as shown in Figure 4) allows the patient to prepare for their consultation by entering their concerns and when they select continue, presents them with a more detailed symptom questionnaire (Fig. 5). [0073] discloses “The pre-consultation patient portal further is configured to enable the patient to prepare his/or her scheduled consultation with the clinician.” This indicates that the symptom questionnaire is sent to obtain patient information after the appointment has been scheduled.
Applicant further argues: Further, the "patient portal" of Van De Steen represents a more significant problem with the Office Action's employment of Van De Steen as a primary reference. Van De Steen Figure 1 clearly shows a system wherein decision making related to differential diagnoses is made by a "differential diagnosis module" (see Van De Steen Paragraph [0077]). Though this "differential diagnosis module", like the appointment scheduler, interacts with the patient via the patient portal, Van De Steen does not teach or suggest that the logic of the "differential diagnosis module" ever exists or executes on the client (patient) device. While generating questions, the "differential diagnosis module" consults a "symptom- diagnosis database" (see Van De Steen Paragraph [0076]). This "symptom-diagnosis database" is disclosed as preferably receiving post-consultation diagnosis data to increase a knowledgebase over time (see Van De Steen Paragraph [0076]), which strongly suggests that the "symptom- diagnosis database" is conceived by Van De Steen as a centralized repository executing on a server or server-like distributed computing infrastructure. As stated above, the "differential diagnosis module", which may also execute on a server or distributed server-like computing infrastructure, is constantly in communication with both the "symptom diagnosis database" and the "patient portal". In fact, the implication of Figure 1 is that only the pre- and post-consultation "patient portals" and the "clinician portal" execute client-side, and that these portals are merely surface- level user interfaces which rely on systems remote to the client device to perform anything beyond the most basic of logic. This implication is in line with conventional methods for structuring computing systems, and Applicant cannot find any language in the disclosure of Van De Steen inconsistent with this implication. Such an architecture is fundamentally incompatible with the architecture of the instant disclosure's systems and methods, which generate a questionnaire via server or distributed infrastructure prior to sending the questionnaire to the patient. With the techniques of the present disclosure and as explained above in response to the 35 U.S.C. §101 rejections, during a period of time in which the patient is filling out the questionnaire no further network communication or server-side computational load is required. This is achieved through embedded logic in the active sheet that represents a fully self-contained set of data for deciding what questions to prompt the patient with.
The Examiner has applied new art in view of the amendments and Applicant’s arguments to teach the questionnaire with embedded logic to be executed by one computer interpreted as the patient device. As such, Applicant’s arguments with respect to claim(s) 1 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The dependent claims 2-20 and 22-23 have not been amended and as such are included in the new prior art rejection.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Tommasi et al. (US 20200335183 A1) teaches: Intelligent Generation of Customized Questionnaires.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALAK M NASSER whose telephone number is (703)756-4610. The examiner can normally be reached M-F 8:00 AM-5:00 PM.
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/MALAK M NASSER/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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