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 .
The amendments were received on 7/10/2025. Claims 1-5, 7-13, 15-26, and 32-57 where claims 1-5, 7-13, 15-26, and 32-52 were previously presented, claims 6, 14, and 27-31 were cancelled, and claims 53-57 are newly added.
Specification
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: The prior-filed application (parent application) is 15/356,933 includes up to paragraph 146 (which discusses Figure 17); which corresponds to paragraph 146 in the instant application. However, the instant application includes additional paragraphs from paragraphs 147 through 171 that includes new discussions of multiple new features that do not appear to be discussed in the prior-filed application and thus the respective specification appears to recite new matter.
Claim Objections
The applicant amended the claims to address the previous claim objections. In view of the amendments, the respective previous objections have been withdrawn.
Claims 4, 9, and 19 are objected to because of the following informalities:
Claim 19 recites “from the ranked ordered disease list…” in the first limitation of the claim on page 8; however, claim 19 depends upon claim 1 which does not recite any rank ordered disease list. The Examiner recommends changing “the” to “a”; or, alternatively, indicating a ranking step or some other step for generating the appropriate listing.
Claim 4 recites “for a next ranked diagnosis” in the body of claim. Claim 4 depends upon claim 1 where claim 1 makes no mention of any ranking of a diagnosis.
Claim 9 recites the phrase “current medial signs and symptoms data” in the body of the claim where the word “medial” is probably meant to be “medical”.
Appropriate correction is required.
35 USC § 112
The applicant amended the claims to address the 35 USC 112 rejections. In view of the amendments, the respective 35 USC 112 rejections have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-13, 15-19, and 53-57 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 53, and 56 recites the limitation "the presented diagnostic questions from the user" in the body of the claim. There is insufficient antecedent basis for this limitation in the claim. The previous limitation indicates that the user is presented “one or more diagnostic questions”; thus it is unclear if one question is presented how multiple responses are received. The Examiner recommends changing “presented diagnostic questions” to “presented one or more diagnostic questions”.
Claims 2-5, 7-13, 15-19, 54, 55, and 57 depend upon claims 1, 53, and 56 and inherit the same deficiencies as noted above. Therefore, the respective dependent claims are rejected for similar reasons as discussed above.
Claim 56 recites the limitation "said isolated common disease data" in the body of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 56 makes no mention of common disease data nor isolated disease data. Based on limitations in other claims, e.g. claim 42, those claims have an active isolating step, the incorporation of which could help provide antecedent basis to the claim term.
Claim 57 depends upon claims 56 and inherits the same deficiencies as the parent claim as discussed above and is rejected for similar reasons as discussed above.
Claims 53 and 56 recite the limitation "the selected diagnosis" in the body of the claims. There is insufficient antecedent basis for this limitation in the claim. The respective independent claims do not appear to explicitly recite any step that selects a diagnosis for analysis; for purposes of compact prosecution, the Examiner is construing the “calculating a diagnosis-specific score” to be construed as “calculating a diagnosis-specific score for a selected diagnosis by assigning weights…”.
Claims 54, 55, and 57 depend upon claims 53 and 56 and inherit the same deficiencies as their parent claim as discussed above and are rejected for similar reasons as discussed above.
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 1-5, 7-13, 15-26, 32-44, 46-50, and 52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With regard to claim 1, this claim recites:
Step 2A, Prong One:
The claim recites the following limitations which are drawn towards an abstract idea:
A method for evaluating a patient diagnosis, the method comprising: determining a diagnosis data based on the received patient medical clinical data including a selected diagnosis; linking one or more of diagnostic questions specific to the diagnosis (recites mental process step of evaluating and judging that medical staff would perform to determine what questions to ask a patient to figure out what ails them; which is also similar to methods of organizing human activity including managing interactions between people, i.e. medical staff asking questions to assist a patient);
calculating a diagnosis-specific score by assigning weights to each received response based on disease-specific diagnostic significance (recites mental process step and organizing human activity step of evaluating information and determining/judging the weight of the respective answer for making a decision);
comparing the diagnosis-specific score to a diagnosis threshold value; confirming or rejecting the selected diagnosis based on the comparison (recites mental process step involving mathematical calculations and comparisons to see if the summation is above some determined value, i.e. threshold);
generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive only if the total sum equals or exceeds the threshold value assigned to the selected diagnosis data, and the diagnosis confirmation signal is negative only if the total sum is lower than the threshold value assigned to the selected diagnosis data (recites mental process step involving mathematical calculations and comparisons to see if the summation is above some determined value, i.e. threshold).
As seen from above, the identified limitations recite concepts associated with an abstract idea and thus the respective claim recites a judicial exception (see 2106.04(a)) and thus requires further analysis as discussed below.
Step 2A, Prong Two:
The following limitations have been identified as being additional elements as discussed below.
receiving patient medical clinical data (recites insignificant extrasolution activity of receiving information/mere data gathering, see MPEP 2106.05(g));
presenting the linked one or more diagnostic questions to a user via a graphical user interface (recites insignificant extrasolution activity of transmitting information, see MPEP 2106.05(g));
receiving responses to the presented diagnostic questions from the user (recites insignificant extrasolution activity of receiving information, see MPEP 2106.05(g));
This judicial exception is not integrated into a practical application because, as seen from the above discussion, the identified limitations did not integrate the judicial exception into a practical application (see MPEP 2106.04(d)).
Step 2B:
Below is the analysis of the claims:
receiving patient medical clinical data (recites well-understood, routine, and conventional activity of receiving information/mere data gathering, see MPEP 2106.05(d));
presenting the linked one or more diagnostic questions to a user via a graphical user interface (recites well-understood, routine, and conventional activity of transmitting information, see MPEP 2106.05(d));
receiving responses to the presented diagnostic questions from the user (recites well-understood, routine, and conventional activity of receiving information, see MPEP 2106.05(d));
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as seen from above, the respective claim elements taken individually do not amount to significantly more than the judicial exception. When taken as a whole (in combination), the claim also does not amount to significantly more than the abstract idea because the additional elements provide recite insignificant extrasolution activity amount to well-understood, routine, and conventional activity of receiving and transmitting/sending information.
With regard to claim 2, this claim recites wherein the diagnosis confirmation signal comprises: providing diagnostic confirmation and treatment data related to the selected diagnosis data, wherein the diagnostic confirmation and treatment data provides information related to the treatment of the selected diagnosis data (which recites insignificant extrasolution activity of transmitting/providing information over a network, which amounts to well-understood, routine, and conventional activity of providing/transmitting information over a network (see MPEP 2106.05(d)) and adds no meaningful limitation beyond that of the abstract idea).
With regard to claim 3, this claim recites wherein in response to the diagnostic confirmation signal being positive, the method further comprises: outputting at least one of patient triage data related to the diagnosis data, treatment data related to the diagnosis data, evidence-based treatment options related to the diagnosis data, and treatment protocol data related to the diagnosis data (recites insignificant extrasolution activity of transmitting/providing information over a network, which amounts to well-understood, routine, and conventional activity of providing/transmitting information over a network (see MPEP 2106.05(d)) where the type of data recites field of use limitations to describe what the data means (see MPEP 2106.05(h)) and adds no meaningful limitation beyond that of the abstract idea).
With regard to claim 4, this claim recites wherein if the diagnosis-specific score does not meet the threshold value, the method further comprises evaluating an alternative diagnosis by repeating the steps for a next ranked diagnosis (recites mental process or method of human activity step of evaluating and judging that medical staff would perform to determine what questions to ask a patient to figure out what ails them).
With regard to claim 5, this claim recites where in a patient-specific severity of illness score with a given medical diagnosis, comprising the steps of:
accessing patient-specific medical clinical data from electronic medical records (EMR) associated with any patient encounter or prior encounter data saved in the EMR (this relates to insignificant extra-solution activity of data gathering, similar to retrieving information from memory, see MPEP 2106.05(d));
linking the patient-specific medical clinical data with a medical database (recites mental process steps of identifying/evaluating steps similar to a person linking (to make a connection between two things) clinical data to medical information),
wherein the medical database comprises medical clinical data and scores associated with each medical clinical data relevant to said medical data (recites field of use limitations describing particular information that is stored, see MPEP 2106.05(h));
applying predetermined rules set within the medical clinical database to add, subtract, and multiply scores associated with each medical clinical data, based on the patient's medical diagnosis and clinical parameters (this limitation relates to mental process steps involving mathematical calculations);
and analyzing the scores related to each medical clinical data to derive a patient specific severity of illness score (recites mental process step of evaluating scores to “derive” or make a judgement/decision).
With regard to claim 7, this claim recites wherein the patient-specific medical clinical data comprises data related to at least one of: patient vital signs data; demographic data; current medial signs and symptoms data; current medical diagnoses data; past medical diagnoses data; past surgical history data; family medical history data; social history data; laboratory data; image array data of a patient face or a body part; video array data of a patient; voice array data of a patient; radiological data; current medication data; and or microbiological data (recites particular data items that the judicial exception uses which relate to field of use limitations describing the data, see MPEP 2106.05(h)).
With regard to claim 8, this claim recites wherein the predetermined rules within the medical clinical database are customizable to accommodate variations in medical diagnosis and patient characteristics (recites mental process steps of evaluating and assessing information about an individual and what they are more susceptible of versus other patients/individuals including based on family/past history).
With regard to claim 9, this claim recites wherein the severity of illness score is calculated using a weighted algorithm that assigns different weights to the scores associated with each medical clinical data based on their relative importance in determining the patient's disposition (which recites mental process steps of utilizing mathematical calculations to generate a score).
With regard to claim 10, this claim recites generating a report indicating the patient-specific severity of illness score (recites insignificant extrasolution activity of outputting information similar to well-understood, routine, and transmitting information, see MPEP 2106.05(d)) and recommending the appropriate disposition category for the patient based on the severity of illness score (recites mental process steps associated with making judgements/determinations on what to recommend based on the illness score).
With regard to claim 11, this claim recites wherein the medical database is updated with the latest medical clinical data and scores to ensure accuracy and relevance in determining the patient's disposition decisions (this claim recites insignificant extrasolution activity of updating data periodically, like electronic recordkeeping or updating a log and amounts to well-understood, routine, and conventional activity of updating data periodically like electronic recordkeeping or updating a log; see MPEP 2106.05(d)).
With regard to claim 12, this claim recites providing real-time alerts to healthcare providers when the patient-specific severity of illness score indicates a change in the patient's condition that may necessitate a different disposition category (this claim recites insignificant extrasolution activity of transmitting information which amounts to well-understood, routine, and conventional activity of transmitting information, see MPEP 2106.05(d)).
With regard to claim 13, this claim recites wherein the method is implemented using computer software and hardware configured to access, link, analyze, and calculate the severity of illness score based on the patient's medical clinical data stored in the electronic medical records encounters (recites merely applying the judicial exception on a computer, see MPEP 2106.05(f)).
With regard to claim 15, this claim recites wherein said generating data in response to said analyzed answers to said diagnostic questions comprises, the treatment data related to the another one of the plurality of diseases, the evidence-based treatment options related to the another one of the plurality of diseases, and the treatment protocol data related to the another one of the plurality of diseases (recites at a high-level of generality, particular type of data which amounts to field of use limitations, see MPEP 2106.05(h))).
With regard to claim 16, this claim recites wherein one of the patient-specific medical clinical data include at least one of texts, images of body parts, facial pictures, dermatological pictures, sound of a patient or patient body parts, voice data of a patient, or an image of a patient medical data (which recites technological environment limitations describing the data format type from computer data file formats for use with the judicial exception, see MPEP 2106.05(h)).
With regard to claim 17, this claim recites wherein the patient-specific medical clinical data or the signs or symptoms include at least one of a problem experienced by the patient and clinical medical data including at least one of disease data, laboratory data, radiological data, microbiological data, and any abnormal clinical findings (which recites field of use limitations describing the type of data that is gathered/observed, see MPEP 2106.05(h)).
With regard to claim 18, this claim recites wherein in response to the diagnostic confirmation signal being positive, the method further comprises: outputting at least one of patient triage data related to the diagnosis data, treatment data related to the diagnosis data, evidence-based treatment options related to the diagnosis data, and treatment protocol data related to the diagnosis data (which recites insignificant extrasolution activity of transmitting information which amounts to well-understood, routine, and conventional activity of transmitting information [see MPEP 2106.05(d)] where the particular data being transmitted relates to field of use limitations [see MPEP 2106.05(h)]).
With regard to claim 19, this claim recites wherein when the diagnosis confirmation signal is negative, the method further comprises: linking another disease from the rank ordered disease list with diagnostic questions specific to the disease data (recites mental process step of evaluating and judging that medical staff would perform to determine what questions to ask a patient to figure out what ails them);
illustrating one or more of the diagnostic questions to a user in response to selected disease data, wherein the illustrated diagnostic questions are specific to the selected disease data (recites insignificant extrasolution activity of transmitting/displaying information which amounts to well-understood, routine, and conventional activity of transmitting/illustrating information over a network (e.g. on a display screen); see MPEP 2106.05(d));
providing a selection means for the user to answer the diagnostic questions; (recites using a machine or computer as a tool to implement the abstract idea, such as providing data, see MPEP 2106.05(f));
analyzing the answers to the diagnostic questions; generating data in response to the analyzed answers to the diagnostic questions; establishing a threshold value to be assigned to the selected disease data; establishing a weight for each answer of the diagnostic questions, whereby a positive response to one of the diagnostic questions will be assigned a first weight and a negative response to one of the diagnostic questions will be assigned a second weight (recites mental process step of evaluating information and determining/judging the weight of the respective answer for making a decision);
adding up all of the weights assigned to the answers of the diagnosis questions to obtain a total sum; comparing the threshold value assigned to the selected ranked disease data to the total sum of all of the weights; and generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive only if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative only if the total sum is lower than the threshold value assigned to the selected disease data (recites mental process step involving mathematical calculations and comparisons to see if the summation is above some determined value, i.e. threshold).
With regard to claim 20, this claim recites a non-transitory tangible computer-readable storage medium comprising logic for generating treatment data based on the patient-specific severity of illness score calculated according to the method of claim 5 (recites merely applying the judicial exception on a computer, see MPEP 2106.05(f)),
wherein the treatment data corresponds to the following categories: treatment data related to a high patient-specific severity of illness score; treatment data related to a moderate patient-specific severity of illness score; and treatment data related to a low patient-specific severity of illness score (recites various categories for the data which amounts to field of use limitations describing how the data is categorized, see MPEP 2106.05(h)).
With regard to claim 21, this claim recites logic for automatically assigning patients to the-an appropriate treatment based on the calculated severity of illness score (which recites mental process step of making an evaluation and judgment).
With regard to claim 22, this claim recites wherein the logic for generating treatment data takes into consideration additional patient-specific factors, such as complications of treatments, and new clinical conditions developed during the course of treatments (which amounts to field of use limitations describing particular data that is intended to be used/considered, see MPEP 2106.05(h)).
With regard to claim 23, this claim recites logic for periodically reevaluating the patient-specific severity of illness score accordingly (which recites the above identified abstract idea of doing follow-up evaluations at a later time).
With regard to claim 24, this claim recites wherein the logic for generating treatment data is implemented in a healthcare information system that interfaces with electronic medical records (EMR) and healthcare providers' decision-making processes to facilitate seamless patient care management (which recites technological environment and field of use limitations associated with medical information systems, see MPEP 2106.05(h)).
With regard to claim 25, this claim recites wherein the logic for generating treatment data includes an alerting mechanism to notify healthcare providers of changes in the patient's severity of illness score (this recites insignificant extrasolution activity of transmitting information which amounts to well-understood, routine, and conventional activity of transmitting information, see MPEP 2106.05(d)).
With regard to claim 26, this claim recites logic for generating comprehensive treatment plans and recommendations for patients based on their severity of illness scores and relevant clinical data (this claim recites mental process steps taken to evaluate and judge how best to help the patient).
With regard to claim 32, this claim recites:
Step 2A, Prong One:
The claim recites the following limitations which are drawn towards an abstract idea:
A system of a computerized physician order entry module to
As seen from above, the identified limitations recite concepts associated with an abstract idea and thus the respective claim recites a judicial exception (see 2106.04(a)) and thus requires further analysis as discussed below.
Step 2A, Prong Two:
The following limitations have been identified as being additional elements as discussed below.
A system of a computerized physician order entry module to receive, insignificant extrasolution activity of receiving and transmitting information, see MPEP 2106.05(g)),
the system comprising: an input device to allow a user to input the hand-written medical order (recites computer hardware at a high-level of generality such that the computer hardware is recited as a tool to implement the abstract idea, see MPEP 2106.05(f));
a storage device configured to store the hand-written medical order (recites computer hardware at a high-level of generality such that the computer hardware is recited as a tool to implement the abstract idea, see MPEP 2106.05(f));
and a central processing unit [recites generic computer hardware (see MPEP 2106.05(f) to implement the abstract idea] to transmit the hand-written medical order to a predetermined location or predetermined recipient
This judicial exception is not integrated into a practical application because, as seen from the above discussion, the identified limitations did not integrate the judicial exception into a practical application (see MPEP 2106.04(d)).
Step 2B:
Below is the analysis of the claims:
A system of a computerized physician order entry module to receive, understood, routine, and conventional activity of receiving and transmitting information, see MPEP 2106.05(d)),
the system comprising: an input device to allow a user to input the hand-written medical order (recites computer hardware at a high-level of generality such that the computer hardware is recited as a tool to implement the abstract idea, see MPEP 2106.05(f));
a storage device configured to store the hand-written medical order (recites computer hardware at a high-level of generality such that the computer hardware is recited as a tool to implement the abstract idea, see MPEP 2106.05(f));
and a central processing unit [recites generic computer hardware (see MPEP 2106.05(f) to implement the abstract idea] to transmit the hand-written medical order to a predetermined location or predetermined recipient
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as seen from above, the respective claim elements taken individually do not amount to significantly more than the judicial exception. When taken as a whole (in combination), the claim also does not amount to significantly more than the abstract idea because the additional elements provide a generic recitation of some means (such as a computer) as a tool to help implement the abstract idea as well as receiving/transmitting information.
With regard to claim 33, this claim recites wherein the input device comprises at least one of an electronic pen and a touch screen of at least one of a mobile device, a smart phone, a tablet, a laptop, and a desktop computer to allow the user to directly perform the hand-writing of the hand-written medical order (which recites usage of high-generality computer components for implementing the abstract idea, see MPEP 2106.05(f)).
With regard to claim 34, this claim recites a display device to display the hand-written medical order as the user writes the hand-written medical order on a touch screen electronic screen (recites generic computer hardware at a high-level of generality to implement the abstract idea, see MPEP 2106.05(f)).
With regard to claim 35, this claim recites wherein the hand-written medical order includes at least one of a patient name, a time-stamp, a date, a prescription, a medical procedure, and a signature of the user (which recites field of use limitations describing the data to be used/entered, see MPEP 2106.05(h)).
With regard to claim 36, this claim recites wherein the storage device stores the hand- written medical order or notes as part of a medical history of the patient (which recites insignificant extrasolution activity of electronic recordkeeping which amounts to well-understood, routine, and conventional activity of electronic recordkeeping, see MPEP 2106.05(d)).
With regard to claim 37, this claim recites a computerized physician order entry module comprising: an input device to allow a user to input the hand-written medical order (recites computer hardware at a high-level of generality such that the computer hardware is recited as a tool to implement the abstract idea, see MPEP 2106.05(f));
converting electronic hand-written orders into computer texts using optical character recognition software (which recites insignificant extrasolution activity of scanning/extracting information from a document; which amounts to well-understood, routine, and conventional activity of electronically scanning/extracting information from a document, see MPEP 2106.05(d));
a storage device configured to store the hand-written medical order (recites computer hardware at a high-level of generality such that the computer hardware is recited as a tool to implement the abstract idea, see MPEP 2106.05(f));
and a central processing unit [recites generic computer hardware (see MPEP 2106.05(f) to implement the abstract idea] to transmit the hand-written medical order to a redetermined location or predetermined recipient based on the information in the hand- written medical order (recites well-understood, routine, and conventional activity of transmitting information, see MPEP 2106.05(d)).
With regard to claim 38, this claim recites wherein the input device comprises at least one of an electronic pen, a touch screen of a mobile device, a smart phone, tablet, a laptop, a desktop to allow the user to directly perform the hand-writing of the hand- written medical order (which recites usage of high-generality computer components for implementing the abstract idea, see MPEP 2106.05(f)).
With regard to claim 39, this claim recites a display device to display the hand-written medical order as the user writes the hand-written medical order in a touch screen electronic screen (recites generic computer hardware at a high-level of generality to implement the abstract idea, see MPEP 2106.05(f)).
With regard to claim 40, this claim recites wherein the hand-written medical order includes at least one of a patient name, a time-stamp, a date, a prescription, a medical procedure, and a signature of the user (which recites field of use limitations describing the data to be used/entered, see MPEP 2106.05(h)).
With regard to claim 41, this claim recites wherein the storage device stores the hand- written medical order as part of a medical history of the patient (which recites insignificant extrasolution activity of electronic recordkeeping which amounts to well-understood, routine, and conventional activity of electronic recordkeeping, see MPEP 2106.05(d)).
With regard to claim 42, this claim recites
Step 2A, Prong One:
The claim recites the following limitations which are drawn towards an abstract idea:
a method of generating a ranked high probability differential medical diagnosis and confirming a ranked diagnosis comprising:
connecting the first medical data with the master differential diagnosis medical data tables; connecting the second medical data with the master differential diagnosis medical data tables (recites mental process steps of evaluating/comparisons and making a connection/decision/judgement between two data sets such as identifying the relevant/desired data);
linking one or more of diagnostic questions to the top ranked disease data, wherein the one or more diagnostic questions are specific to the selected diagnosis data (recites mental process step or method of human activity of evaluating and judging that medical staff would perform to determine what questions to ask a patient to figure out what ails them);
analyzing the answers to the diagnostic questions; and establishing a weight for each answer of the diagnostic questions, whereby a positive response to one of the diagnostic questions will be assigned a first weight and a negative response to one of the diagnostic questions will be assigned a second weight (recites mental process step or method of human activity of evaluating information and determining/judging the weight of the respective answer for making a decision including for medical evaluations);
adding up all of the weights assigned to the answers of the diagnosis questions to obtain a total sum; establishing a threshold value to be assigned to the selected diagnosis data; comparing the threshold value assigned to the selected diagnosis data to the total sum of all of the weights; and generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected disease data (recites mental process step involving mathematical calculations and comparisons to see if the summation is above some determined value, i.e. threshold).
As seen from above, the identified limitations recite concepts associated with an abstract idea and thus the respective claim recites a judicial exception (see 2106.04(a)) and thus requires further analysis as discussed below.
Step 2A, Prong Two:
The following limitations have been identified as being additional elements as discussed below.
collecting a first medical data from a patient; collecting a second medical data from the patient (recites insignificant extrasolution activity of mere data gathering, see MPEP 2106.05(g));
accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data (recites insignificant extrasolution activity of retrieving information over a network, see MPEP 2106.05(g));
isolating all disease data common to said master differential diagnosis medical data tables associated with said first medical data, and said second medical data; generating a listing of said isolated common disease data associated with said first medical data, and second medical data; and arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data and said second medical data (recites insignificant extrasolution activity of sorting/filtering data into desired and undesired while also sorting information based on how often it appears, see MPEP 2106.05(g));
providing a selection means to the user to answer the diagnostic questions (recites using a machine or computer as a tool to implement the abstract idea, such as providing data, see MPEP 2106.05(f)).
This judicial exception is not integrated into a practical application because, as seen from the above discussion, the identified limitations did not integrate the judicial exception into a practical application (see MPEP 2106.04(d)).
Step 2B:
Below is the analysis of the claims:
collecting a first medical data from a patient; collecting a second medical data from the patient (recites well-understood, routine, and conventional activity of mere data gathering, see MPEP 2106.05(d));
accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data (recites well-understood, routine, and conventional activity of retrieving information over a network, see MPEP 2106.05(d));
isolating all disease data common to said master differential diagnosis medical data tables associated with said first medical data, and said second medical data; generating a listing of said isolated common disease data associated with said first medical data, and second medical data; and arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data and said second medical data (recites well-understood, routine, and conventional activity of sorting/filtering data into desired and undesired while also sorting information based on how often it appears, see MPEP 2106.05(d));
providing a selection means to the user to answer the diagnostic questions (recites using a machine or computer as a tool to implement the abstract idea, such as providing data, see MPEP 2106.05(f)).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as seen from above, the respective claim elements taken individually do not amount to significantly more than the judicial exception. When taken as a whole (in combination), the claim also does not amount to significantly more than the abstract idea because the additional elements provide a generic recitation of some means (such as a computer) as a tool to help implement the abstract idea as well as limitations discussing retrieving and sorting information at a high-level of generality.
With regard to claim 43, ranking said disease data within said master differential diagnosis medical data table associated with said first medical data, whereby more prevalent disease data is ranked ahead of less prevalent disease data (this claim recites insignificant extrasolution activity of sorting information which amounts to well-understood, routine, and conventional activity of sorting information (see MPEP 2106.05(d)); where the particular information (more prevalent disease data) recites field of use limitations describing the data being sorted; see MPEP 2106.05(h)).
With regard to claim 44, this claim recites arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the medical data that concerns said patient more instead of the first medical data (this claim recites insignificant extrasolution activity of sorting information which amounts to well-understood, routine, and conventional activity of sorting information (see MPEP 2106.05(d))).
With regard to claim 45, this claim recites arranging said isolated common disease data in said generated listing in a ranked order, followed by the relative ranked position of said isolated disease data within said first medical data table (which recites a particular order of ranking that amounts to more than well-understood, routine, and conventional activity of sorting and thus is significantly more than the abstract idea).
With regard to claim 46, this claim recites wherein said generating data in response to said analyzed answers to said diagnostic questions comprises: analyzing said diagnosis confirmation signal (recites mental process step of evaluation/judgement) and illustrating data to said user, wherein if said diagnosis confirmation signal is positive, said illustrated data will include treatment data related to said selected ranked disease data; and if said diagnosis confirmation signal is negative, said illustrated data will include data notifying a user that said selected ranked disease data is not a diagnosis (recites insignificant extrasolution activity of transmitting information which amounts to well-understood, routine, and conventional activity of transmitting information, see MPEP 2106.05(d)).
With regard to claim 47, this claim recites
Step 2A, Prong One:
The claim recites the following limitations which are drawn towards an abstract idea:
A method of generating a ranked high probability differential medical diagnosis and confirming a ranked diagnosis comprising:
connecting the first medical data with the said master differential diagnosis medical data tables; connecting the second medical data with the said master differential diagnosis medical data; connecting the third medical data with the said master differential diagnosis medical data; (recites mental process steps of evaluating/comparisons and making a connection/decision/judgement between two data sets such as identifying the relevant/desired data);
linking one or more of diagnostic questions to the top ranked disease data, wherein the one or more diagnostic questions are specific to the selected diagnosis data (recites mental process step of evaluating and judging that medical staff would perform to determine what questions to ask a patient to figure out what ails them);
analyzing the answers to the diagnostic questions; and establishing a weight for each answer of the diagnostic questions, whereby a positive response to one of the diagnostic questions will be assigned a first weight and a negative response to one of the diagnostic questions will be assigned a second weight (recites mental process step of evaluating information and determining/judging the weight of the respective answer for making a decision);
adding up all of the weights assigned to the answers of the diagnosis questions to obtain a total sum; establishing a threshold value to be assigned to the selected diagnosis data; comparing the threshold value assigned to the selected diagnosis data to the total sum of all of the weights; and generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected disease data (recites mental process step involving mathematical calculations and comparisons to see if the summation is above some determined value, i.e. threshold).
As seen from above, the identified limitations recite concepts associated with an abstract idea and thus the respective claim recites a judicial exception (see 2106.04(a)) and thus requires further analysis as discussed below.
Step 2A, Prong Two:
The following limitations have been identified as being additional elements as discussed below.
collecting a first medical data from a patient; collecting a second medical data from the patient; collecting a third medical data from the patient (recites insignificant extrasolution activity of mere data gathering, see MPEP 2106.05(g));
accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data (recites insignificant extrasolution activity of retrieving information over a network, see MPEP 2106.05(g));
generating a listing of isolated common disease data associated with said first medical data, second medical data, and said third medical data; and arranging all of said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data table, said second medical data table, and said third medical data table (recites insignificant extrasolution activity of sorting/filtering data into desired and undesired while also sorting information based on how often it appears, see MPEP 2106.05(g));
providing a selection means to the user to answer the diagnostic questions (recites using a machine or computer as a tool to implement the abstract idea, such as providing data, see MPEP 2106.05(f)).
This judicial exception is not integrated into a practical application because, as seen from the above discussion, the identified limitations did not integrate the judicial exception into a practical application (see MPEP 2106.04(d)).
Step 2B:
Below is the analysis of the claims:
collecting a first medical data from a patient; collecting a second medical data from the patient; collecting a third medical data from the patient (recites well-understood, routine, and conventional activity of mere data gathering, see MPEP 2106.05(d));
accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data (recites well-understood, routine, and conventional activity of retrieving information over a network, see MPEP 2106.05(d));
generating a listing of said isolated common disease data associated with said first medical data, second medical data, and said third medical data; and arranging all of said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data table, said second medical data table, and said third medical data table (recites well-understood, routine, and conventional activity of sorting/filtering data into desired and undesired while also sorting information based on how often it appears, see MPEP 2106.05(d));
providing a selection means to the user to answer the diagnostic questions (recites using a machine or computer as a tool to implement the abstract idea, such as providing data, see MPEP 2106.05(f)).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as seen from above, the respective claim elements taken individually do not amount to significantly more than the judicial exception. When taken as a whole (in combination), the claim also does not amount to significantly more than the abstract idea because the additional elements provide a generic recitation of some means (such as a computer) as a tool to help implement the abstract idea as well as limitations discussing retrieving and sorting information at a high-level of generality.
With regard to claim 48, this claim recites wherein said generating data in response to said analyzed answers to said diagnostic questions comprises: analyzing said diagnosis confirmation signal (recites mental process steps of evaluation/judgement) and illustrating data to said user, wherein if said diagnosis confirmation signal is positive, said illustrated data will include treatment data related to said selected ranked disease data; and if said diagnosis confirmation signal is negative, said illustrated data will include data notifying a user that said selected ranked disease data is not a diagnosis (recites insignificant extrasolution activity of transmitting information which amounts to well-understood, routine, and conventional activity of transmitting information, see MPEP 2106.05(d)).
With regard to claim 49, this claim recites ranking said disease data within said master differential diagnosis medical data table associated with said first medical data, whereby more prevalent disease data is ranked ahead of less prevalent disease data (this claim recites insignificant extrasolution activity of sorting information which amounts to well-understood, routine, and conventional activity of sorting information (see MPEP 2106.05(d)); where the particular information (more prevalent disease data) recites field of use limitations describing the data being sorted; see MPEP 2106.05(h)).
With regard to claim 50, this claim recites arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the medical data that concerns said patient more instead of the first medical data (this claim recites insignificant extrasolution activity of sorting information which amounts to well-understood, routine, and conventional activity of sorting information (see MPEP 2106.05(d))).
With regard to claim 51, this claim recites arranging said isolated common disease data in said generated listing in a ranked order, followed by the relative ranked position of said isolated disease data within said first medical data table followed by the relative ranked position of said isolated disease data within said second medical data table (which recites a particular order of ranking that amounts to more than well-understood, routine, and conventional activity of sorting and thus is significantly more than the abstract idea).
With regard to claim 52, this claim recites ranking said disease data within said differential diagnosis medical data table associated with said second medical data whereby more prevalent disease data is ranked ahead of less prevalent disease data (this claim recites insignificant extrasolution activity of sorting information which amounts to well-understood, routine, and conventional activity of sorting information (see MPEP 2106.05(d)); where the particular information (more prevalent disease data) recites field of use limitations describing the data being sorted; see MPEP 2106.05(h))).
With regard to claims 53 and 56, these claims recite limitations similar to those of claims 45 and 51, and are deemed to recite particular steps that amount more than the well-understood, routine, and conventional activity of sorting as discussed above. Respective dependent claims stand eligible based on their dependency of the respective independent claims.
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.
Claims 32-35 and 37-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by over Becker et al [US 2002/0019749 A1].
With regard to claim 32, Becker teaches a system of a computerized physician order entry module to receive, process, and transmit a hand-written medical order corresponding to a patient, whereas the patient is enlisted in the electronic medical record (see Figure 9; see paragraphs [0041], [0045], [0047], and [0106]-[0107] and [0109]; the system can determine where to send the entered order information as well as what information is being ordered, i.e. prescriptions or lab tests), the system comprising:
an input device to allow a user to input the hand-written medical order (see paragraphs [0078]-[0080] and [0109]; the input device can include an electronic pen or stylus incorporated into a variety of other devices for receiving handwritten inputs);
a storage device configured to store the hand-written medical order (see paragraphs [0050], [0077], [0095], and [0110]; the device includes storage for storing information including input information);
and a central processing unit to transmit the hand-written medical order to a predetermined location or predetermined recipient based on the information in the hand- written medical order (see Figure 9; see paragraphs [0041], [0045], [0047], and [0107]; the system can determine where to send the entered order information as well as what information is being ordered, i.e. prescriptions or lab tests).
With regard to claim 33, Becker teaches wherein the input device comprises at least one of an electronic pen and a touch screen of at least one of a mobile device, a smart phone, a tablet, a laptop, and a desktop computer to allow the user to directly perform the hand-writing of the hand-written medical order input (see paragraphs [0078]-[0080] and [0109]; the input device can include an electronic pen or stylus incorporated into a variety of other devices for receiving handwritten inputs).
With regard to claim 34, Becker teaches a display device to display the hand-written medical order as the user writes the hand-written medical order on a touch screen electronic screen (see Becker, Figure 2 and paragraphs [0042], [0080] and [0109]; the user can review their input before agreeing to accept their input as an official input for the medical record where a touch sensitive screen can be used).
With regard to claim 35, Becker teaches wherein the hand-written medical order includes at least one of a patient name, a time-stamp, a date, a prescription, a medical procedure, and a signature of the user (see Figure 6 and paragraphs [0084] and [0081]; the system can utilize various pieces of information with the orders including patient name, procedure, prescription).
With regard to claim 37, Becker teaches a computerized physician order entry module comprising: an input device to allow a user to input the hand-written medical order; converting electronic hand-written orders into computer texts using optical character recognition software (see paragraphs [0078]-[0080] and [0109]; the input device can include an electronic pen or stylus incorporated into a variety of other devices for receiving handwritten inputs and being able to recognize the handwriting into a digital format for the computer to be able to use);
a storage device configured to store the hand-written medical order; and a central processing unit to transmit the hand-written medical order to a predetermined location or predetermined recipient based on the information in the hand- written medical order (see paragraphs [0050], [0077], [0095], and [0110]; the device includes storage for storing information including input information; see Figure 9; see paragraphs [0041], [0045], [0047], and [0107]; the system can determine where to send the entered order information as well as what information is being ordered, i.e. prescriptions or lab tests).
With regard to claims 38-40, these claims are substantially similar to claims 33-35 and are rejected for similar reasons as discussed above.
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.
Claims 1-4, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968).
With regard to claim 1, Marchosky teaches a method for evaluating a patient diagnosis, the method comprising: receiving patient medical clinical data (see paragraphs [0025], [0037], [0068], and [0091] and [0179]; the system can collect medical clinical data from a patient);
determining a diagnosis data based on the received patient medical clinical data
linking one or more diagnostic questions specific to the selected diagnosis data (see paragraph [0076]; questions are linked to particular disease diagnosis disease objects);
presenting the linked one or more diagnostic questions to a user via a graphical user interface; receiving responses to the presented diagnostic questions from the user (see paragraphs [0079]-[0081], [0093], and [0167]; the user is presented questions and is able to respond or answer the respective questions);
calculating a diagnosis-specific score by assigning weights to each received response based on diseases-specific diagnostic significance (see paragraphs [0079]-[0080], [0050], [0037] and [0025]; the system reviews the answers to questions and utilizes the associated weights for the respective question and disease diagnosis as part of a summation process to determine an overall score for the respective potential disease).
Marchosky does not appear to explicitly teach:
determining a diagnosis data based on the received patient medical clinical data including a selected diagnosis;
comparing the diagnosis-specific score to a diagnosis threshold value;
confirming or rejecting the selected diagnosis based on the comparison;
generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected diagnosis data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected diagnosis data.
Iliff teaches determining a diagnosis data based on the received patient medical clinical data including a selected diagnosis; comparing the diagnosis-specific score to a diagnosis threshold value; confirming or rejecting the selected diagnosis based on the comparison; generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected diagnosis data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected diagnosis data (see Iliff, paragraphs [0109]-[0111]; lliff968, col 61, lines 20-31; see col 39, lines 13-27; see Iliff’210, col 17, line 49 through col 18, line 3; the system can focus on a particular or selected diagnosis and be able to ask questions and sum up the weights associated with various questions to determine if the score exceeds the threshold to confirm a diagnosis).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky by being able to quickly determine potential diagnosis and provide information about a determined diagnosis based on threshold comparisons as taught by Iliff in order to allow multiple candidate disease diagnoses to be evaluated to determine a candidate diagnosis which will then prioritize questions to the user for that candidate disease diagnosis to quickly determine whether that candidate diagnosis should be the diagnosis for the patient/user.
With regard to claim 2, Marchosky in view of Iliff teach wherein the diagnosis confirmation signal comprises: providing diagnostic confirmation and treatment data related to the selected diagnosis data, wherein the diagnostic confirmation and treatment data provides information related to the treatment of the selected diagnosis data (see Marchosky, paragraph [0082]; Iliff 968, col 38, line 6 through col 41, line 3; see lliff, paragraphs [0109]-[0111]; the system can provide information including latest treatment data for the disease/issue, Iliff’968, col 40, lines 28-46).
With regard to claim 3, Marchosky in view of Iliff teach wherein in response to the diagnostic confirmation signal being positive, the method further comprises: outputting at least one of patient triage data related to the diagnosis data, treatment data related to the diagnosis data, evidence-based treatment options related to the diagnosis data, and treatment protocol data related to the diagnosis data (see Marchosky, paragraph [0082]; Iliff 968, col 38, line 6 through col 41, line 3; see lliff, paragraphs [0109]-[0111]; the system can provide information including latest treatment data for the disease/issue, Iliff’968, col 40, lines 28-46).
With regard to claim 4, Marchosky in view of Iliff teach wherein if the diagnosis-specific score does not meet the threshold value, the method further comprises evaluating an alternative diagnosis by repeating the steps for a next ranked diagnosis (see Marchosky, paragraph [0076]; Iliff, Figure 8 and paragraphs [0111], [0103], and [0011]; the disease/diagnosis weight can be decreased and the respective disease placed in a segregated group with the system repeating the process of asking other questions linked to other diseases)
With regard to claim 18, this claim is substantially similar to claim 3 and is rejected for similar reasons as discussed above.
With regard to claim 19, Marchosky in view of Iliff teach wherein when the diagnosis confirmation signal is negative, the method further comprises: linking another disease from the rank ordered disease list with diagnostic questions specific to the disease data (see Marchosky, paragraph [0076]; Iliff, Figure 8 and paragraphs [0111], [0103], and [0011]; the disease/diagnosis weight can be decreased and the respective disease placed in a segregated group with the system repeating the process of asking other questions linked to other diseases);
illustrating one or more of the diagnostic questions to a user in response to selected disease data, wherein the illustrated diagnostic questions are specific to the selected disease data; providing a selection means for the user to answer the diagnostic questions (see Marchosky, paragraphs [0037] and [0063]; see Iliff, paragraphs [0111] and [0043]; a user interface is provided to allow users to receive and answer questions);
analyzing the answers to the diagnostic questions; generating data in response to the analyzed answers to the diagnostic questions; establishing a threshold value to be assigned to the selected disease data; establishing a weight for each answer of the diagnostic questions, whereby a positive response to one of the diagnostic questions will be assigned a first weight and a negative response to one of the diagnostic questions will be assigned a second weight; adding up all of the weights assigned to the answers of the diagnosis questions to obtain a total sum (see Marchosky, paragraphs [0079]-[0080], [0050], [0037] and [0025]; see Iliff, paragraph [0013] and [0090]; Iliff’210, col 8, line 43; see Iliff’968, col 61, lines 20-31; the system can utilize disease objects where the particular disease object being evaluated can use the yes/no answers for the specific disease object to adjust the total score for that disease; see Iliff968, col 39, lines 14- 18; Iliff’210, col 8, line 47; established threshold can be used to determine if the symptoms match the selected ranked disease/diagnosis);
comparing the threshold value assigned to the selected ranked disease data to the total sum of all of the weights; and generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive only if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative only if the total sum is lower than the threshold value assigned to the selected disease data (see Iliff, paragraphs [0109]-[0111]; lliff968, col 61, lines 20-31; see col 39, lines 13-27; see Iliff’210, col 17, line 49 through col 18, line 3; the system can sum up the weights associated with various questions to determine if the score exceeds the threshold to confirm a diagnosis).
Claims 5, 7-9, 11, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968) in further view of Papageorge [US 2002/0184050 A1].
With regard to claim 5, Marchosky in view of Iliff teach all the claim limitations of claim 1 as discussed above.
Marchosky in view of Iliff teach comprising the steps of: accessing patient-specific medical clinical data from electronic medical records (EMR) associated with any patient encounter or prior encounter data saved in the EMR (see Marchosky, paragraphs [0091], [0099], [0044], and [0082]; health care professionals can utilize the system and have means to access patient-specific medical clinical data including past encounters including past test results);
linking the patient-specific medical clinical data with a medical database, wherein the medical database comprises medical clinical data and scores associated with each medical clinical data relevant to said medical data (see Marchosky, paragraphs [0091], [0099], and [0167]-[0180]; the system can connect the medical clinical data to a database that stores various disease and other medical clinical data and compare perform differential comparisons that will isolate the potential disease data to ones that are common to the user’s first and second medical clinical data; see Iliff, paragraphs [0051], [0090], and [0109]; see Iliff’210, col 29, line 60 through col 30, line 59; Figure 27 and col 46, line 34 through col 47, line 22; the system can use disease objects that themselves include table of symptoms and other information for a particular disease object).
applying predetermined rules set within the medical clinical database to add, subtract, and multiply scores associated with each medical clinical data, based on the patient's medical diagnosis and clinical parameters (see Marchosky, paragraphs [0179] and [0080]; see Iliff’210, col 29, line 60 through col 30, line 59; the system can use disease objects that themselves include table of symptoms and other information for a particular disease object that can be utilized to provide the information to perform the respective calculations for diagnosing a disease; where the system can utilize information including past patient encounters with particular illness/diagnosis and current clinical parameters to modify scores including weighted values (multiplication), as well as adding and subtracting to derive a final score).
Marchosky in view of Iliff appear to teach severity of a symptom but do not appear to explicitly teach:
wherein a patient-specific severity of illness score with a given medical diagnosis to determine the patient’s disposition to different levels of care categories,
and analyzing the scores related to each medical clinical data to derive a patient specific severity of illness score.
Papageorge teaches a severity of illness score (see claim 6 and paragraphs [0041], [0097], and [0083]; the system has means to determine the diseases severity).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the disease management and treatment system of Marchosky in view of Iliff by providing means to evaluate each clinical indicator/symptom as means to determine overall severity level as taught by Papageorge in order to be able to not only evaluate how severe particular clinical indicators/symptoms are but also how severe is the actual illness/disease thus allowing medical personnel to have more information on both symptoms/clinical indicators and overall illness severity so that the medical personnel can make a more informed decision on the best treatment or path forward for their patient.
Marchosky in view of Iliff and Papageorge teach wherein a patient-specific severity of illness score with a given medical diagnosis to determine the patient’s disposition to different levels of care categories, and analyzing the scores related to each medical clinical data to derive a patient specific severity of illness score (see Marchosky, paragraph [0179] and [0180]; Papageorge, paragraphs [0041], [0083] and [0097]; see Iliff’210, col 29, line 60 through col 30, line 59; the system analyzes the user patient information to determine a severity of problem/illness based on an aggregate score of the various clinical indicators/patient information).
With regard to claim 7, Marchosky in view of Iliff in further view of Papageorge teach wherein the patient-specific medical clinical data comprises data related to at least one of: patient vital signs data; demographic data; current medial signs and symptoms data; current medical diagnoses data; past medical diagnoses data; past surgical history data; family medical history data; social history data; laboratory data; image array data of a patient face or a body part; video array data of a patient; voice array data of a patient; radiological data; current medication data; and or microbiological data (see Marchosky, paragraph [0179]; various information can be gathered and stored from the patient including demographics).
With regard to claim 8, Marchosky in view of Iliff in further view of Papageorge teach wherein the predetermined rules within the medical clinical database are customizable to accommodate variations in medical diagnosis and patient characteristics (see Iliff, paragraph [0057] and [0113]; the rules/process used by the system can not only be updated with new information for diagnosis and testing but also utilize patient medical history to help determine how to evaluate the patient and is not statically applying the rules/evaluations).
With regard to claim 9, Marchosky in view of Iliff in further view of Papageorge teach wherein the severity of illness score is calculated using a weighted algorithm that assigns different weights to the scores associated with each medical clinical data based on their relative importance in determining the patient's disposition (see Papageorge, paragraph [0083]; see Marchosky, paragraph [0173]; the severity score can be based on an aggregated score of the clinical indicates/symptoms where the system weight the indicators differently based on the importance of that indicator).
With regard to claim 11, Marchosky in view of Iliff in further view of Papageorge teach wherein the medical database is updated with the latest medical clinical data and scores to ensure accuracy and relevance in determining the patient's disposition decisions (see Iliff, paragraph [0113]; the system allows for connection to a server to allow for updates on new disease information so that the medical system can be as accurate when assisting users as possible).
With regard to claim 13, Marchosky in view of Iliff in further view of Papageorge teach wherein the method is implemented using computer software and hardware configured to access, link, analyze, and calculate the severity of illness score based on the patient's medical clinical data stored in the electronic medical records encounters (see Marchosky, Figure 1; see Iliff, Figure 1a; Papageorge, claim 1 and paragraph [0050]; the system can utilize computer software and hardware to perform various functions).
With regard to claim 15, Marchosky in view of Iliff in further view of Papageorge teach wherein said generating data in response to said analyzed answers to said diagnostic questions comprises, the treatment data related to the another one of the plurality of diseases, the evidence-based treatment options related to the another one of the plurality of diseases, and the treatment protocol data related to the another one of the plurality of diseases (see Marchosky, paragraph [0082]; the system can generate/retrieve respective treatment data for other diseases).
With regard to claim 16, Marchosky in view of Iliff in further view of Papageorge teach wherein one of the patient-specific medical clinical data include at least one of texts, images of body parts, facial pictures, dermatological pictures, sound of a patient or patient body parts, voice data of a patient, or an image of a patient medical data (see Marchosky, paragraph [0052]; see Iliff, paragraph [0043]; various data format types can be used and associated with patient medical data).
With regard to claim 17, Marchosky in view of Iliff in further view of Papageorge teach wherein the patient-specific medical clinical data or the signs or symptoms include at least one of a problem experienced by the patient and clinical medical data including at least one of disease data, laboratory data, radiological data, microbiological data, and any abnormal clinical findings (see Marchosky, paragraphs [0026], [0038], and [0179] and [0086]; various tests and related data can be used by the system as well as means to receive information about the problem/symptoms the user is experiencing).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968) in further view of Papageorge [US 2002/0184050 A1] and in further view of Guman et al [US 2017/0039502 A1].
With regard to claim 10, Marchosky in view of Iliff in further view of Papageorge teach all the claim limitations of claims 1 and 5 as discussed above.
Marchosky in view of Iliff in further view of Papageorge teach generating a report indicating the patient-specific severity of illness score (see Papageorge, paragraph [0083]; a report can be created that shows the patient’s severity level based on the aggregate scores, i.e. calculated scores).
Marchosky in view of Iliff and Papageorge teach treatment/therapy recommendations but do not appear to explicitly teach recommending the appropriate disposition category for the patient based on the severity of illness score.
Guman teaches recommending the appropriate disposition category for the patient based on the severity of illness score (see paragraph [0390]; the system can suggest an action based on severity where the patient disposition category (action the patient should take) for the severity is determined including urgent medical care, or routine office visit).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff in further view of Papageorge by being able to suggest or recommend categories/actions to the user/patient as taught by Guman in order to not only provide the information about the potential illness or disease the user is experiencing but also other associated actions/categories that are based on how severity of the illness/disease in order to help the patient get the appropriate care they need.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968) in further view of Papageorge [US 2002/0184050 A1] and in further view of Shusterman [US 2013/0231947 A1].
With regard to claim 12, Marchosky in view of Iliff in further view of Papageorge teach all the claim limitations of claims 1 and 5 as discussed above.
Marchosky in view of Iliff in further view of Papageorge do appear to explicitly teach providing real-time alerts to healthcare providers when the calculated severity of illness score indicates a change in the patient's condition that may necessitate a different disposition category.
Shusterman teaches providing real-time alerts to healthcare providers when
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff in further view of Papageorge by being able to provide alerts based on changes in patient’s condition as taught by Shusterman in order to allow not only the remote monitoring of patient’s medical clinical data remotely but also to be able to act and provide alerts when changes in patient’s condition occur thereby increasing the chances of saving human life by alerting health professionals right away versus storing the results and waiting for someone to review the data and make the determination that something needs to be done, which may be too late at that point.
Marchosky in view of Iliff in further view of Papageorge in further view of Shusterman teach providing real-time alerts to healthcare providers when the patient-specific severity of illness score indicates a change in the patient's condition that may necessitate a different disposition category (see Shusterman, paragraphs [0116]-[0117] and [0160]-[0161]; see Iliff, paragraph [0043]; see Marchosky, paragraphs [0061] and [0045]; the system allows for remote connection to the system to update patient information which can include monitoring patient clinical data and be able to provide alerts, when necessary, based on changes in the patient’s condition).
Claims 20, 22-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968) in further view of Papageorge [US 2002/0184050 A1], and in further view of Kilgore et al [US 2002/0072911 A1].
With regard to claim 20, Marchosky in view of Iliff and Papageorge teach all the claim limitations of claims 1 and 5 as discussed above.
Marchosky in view of Iliff and Papageorge teach a non-transitory tangible computer-readable storage medium (see Iliff, paragraph [0043]) comprising logic for generating treatment data based on the patient-specific severity of illness score calculated according to the method of claim 5 (see claim 5 rejection above),
Marchosky in view of Iliff and Papageorge do not appear to explicitly teach:
wherein the treatment data corresponds to the following categories: treatment data related to a high patient-specific severity of illness score;
treatment data related to a moderate patient-specific severity of illness score;
treatment data related to a low patient-specific severity of illness score.
Kilgore teaches the following categories:
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff in further view of Papageorge by utilizing category codes representative of patient status or severity as taught by Kilgore in order to allow for easy reading and understanding of a patient’s overall condition or status/disposition thus removing the need for medical personnel to translate what a severity score is representative of by utilizing a category code thus ensuring there is no accidental misunderstanding from medical personnel when reviewing the patient’s information of how severe a patient’s status/disposition is thereby allowing medical personnel and the system to be able to treat very severe cases of a disease differently from less severe cases of the disease thus allowing for the system to be robust when handling a variety of different conditions including user characteristics/vitals without being constrained to a one-size-fits-all model that would treat every instance of a particular disease the same even though the patient might be experiencing a high severity level version of that disease.
Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore teach wherein the treatment data corresponds to the following categories: treatment data related to a high patient-specific severity of illness score; treatment data related to a moderate patient-specific severity of illness score; treatment data related to a low patient-specific severity of illness score (see Papageorge, paragraphs [0063]-[0064]; see Marchosky, paragraph [0082]; see Kilgore, paragraph [0043]; the system can determine how severity of disease can impact treatment options that are suggested to the patient or user of the system).
With regard to claim 22, Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore teach wherein the logic for generating treatment data takes into consideration additional patient-specific factors, such as complications of treatments, and new clinical conditions developed during the course of treatments(see Papageorge, paragraph [0055]; see Iliff, paragraph [0057]; see Marchosky, paragraphs [0005], [0038] and [0179]; the system can analyze various pieces of information to determine treatments to recommend including information based on concurrent conditions of the patient, i.e. comorbidities, demographics, i.e. age, and utilizing medical history including patients allergies/reactions to drugs/treatments to help determine or prune certain diseases/ailments thus allowing generation of treatment data that aren’t directed towards those ailments).
With regard to claim 23, Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore teach logic for periodically reevaluating the patient-specific severity of illness score accordingly (see Marchosky, paragraph [0068]; see Papageorge, paragraph [0083]; the system allows users to periodically update their information which in turn allows for reevaluation/calculation of severity of illness score).
With regard to claim 24, Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore teach wherein the logic for generating treatment data is implemented in a healthcare information system that interfaces with electronic medical records (EMR) and healthcare providers' decision-making processes to facilitate seamless patient care management (see Marchosky, Figure 1 and paragraphs [0127]; Papageorge, [0042]; the system interacts with various systems to help generate treatment plans and let medical professionals make decisions).
With regard to claim 26, Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore teach logic for generating comprehensive treatment plans and recommendations for patients based on their severity of illness scores and relevant clinical data (see Papageorge, paragraphs [0063]-[0064]; see Marchosky, paragraph [0082]; the system can determine how severity of disease can impact treatment options that are suggested to the patient or user of the system).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968) in further view of Papageorge [US 2002/0184050 A1] in further view of Kilgore et al [US 2002/0072911 A1] and in further view of Shusterman [US 2013/0231947 A1].
With regard to claim 25, Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore teach all the claim limitations of claims 1, 5, and 20 as discussed above.
Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore do appear to explicitly teach wherein the logic for generating treatment data includes an alerting mechanism to notify healthcare providers of changes in the patient's severity of illness score.
Shusterman teaches wherein the logic for generating treatment data includes an alerting mechanism to notify healthcare providers of changes
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore by being able to provide alerts based on changes in patient’s condition as taught by Shusterman in order to allow not only the remote monitoring of patient’s medical clinical data remotely but also to be able to act and provide alerts when changes in patient’s condition occur thereby increasing the chances of saving human life by alerting health professionals right away versus storing the results and waiting for someone to review the data and make the determination that something needs to be done, which may be too late at that point.
Marchosky in view of Iliff in further view of Papageorge in further view of Kilgore and in further view of Shusterman teach wherein the logic for generating treatment data includes an alerting mechanism to notify healthcare providers of changes in the patient's severity of illness score (see Shusterman, paragraphs [0116]-[0117] and [0160]-[0161]; see Iliff, paragraph [0043]; see Marchosky, paragraphs [0061] and [0045]; the system allows for remote connection to the system to update patient information which can include monitoring patient clinical data and be able to provide alerts, when necessary, based on changes in the patient’s condition).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968) in further view of Papageorge [US 2002/0184050 A1] and in further view of Kilgore et al [US 2002/0072911 A1] and in further view of Guman et al [US 2017/0039502 A1].
With regard to claim 21, Marchosky in view of Iliff in further view of Papageorge and in further view of Kilgore teach all the claim limitations of claims 1, 5, and 20 as discussed above.
Marchosky in view of Iliff in view of Papageorge and in further view of Kilgore teach treatment categories but do not appear to explicitly teach logic for automatically assigning patients to an appropriate treatment based on the calculated severity of illness score.
Guman teaches logic for automatically assigning patients to an appropriate treatment based on the calculated severity of illness score (see paragraph [0390] and [0345]; the system can suggest an action including treatment based on severity where the patient disposition category (action the patient should take) for the severity is determined/assigned and the appropriate or proper treatment is determined).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff in further view of Papageorge and in further view of Kilgore by being able to automatically determine the category for the patient as taught by Guman in order to not only provide the information about the potential illness or disease the user is experiencing but also other associated actions/categories that are based on the severity of the illness/disease in order to help the patient get the appropriate care/treatment they need.
Claims 36 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al [US 2002/0019749 A1] in view of Marchosky et al [US 2002/0029157 A1].
With regard to claim 36, Becker teaches all the claim limitations of claim 32 as discussed above.
Becker does not appear to explicitly teach wherein the storage device stores the hand- written medical order or notes as part of a medical history of the patient.
Marchosky teaches wherein the storage device stores the hand- written medical order or notes as part of a medical history of the patient (see Marchosky, paragraphs [0005] and [0038]; the system keeps track of past medical history including records of prescribed treatments and medications).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical order entry system of Becker by including means to store the orders as part of the patient’s medical history as taught Marchosky in order to keep a complete record of all past medical history information related to the treatment of a patient so that when the patient is being helped again by other health care professionals, the accurate past medical history of the patient can be easily obtained by those health care professionals so that they can become aware of the patient’s history and prior treatments thereby allowing those health care professionals to provide better care for the patient by making more informed decisions on how to treat the patient.
With regard to claim 41, this claim is substantially similar to claim 36 and is rejected for similar reasons as discussed above.
Claims 42-44, 46-50, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Marchosky [US 2002/0029157 A1] in view of Iliff [US 2009/0007924 A1] (with Iliff [US 6,468,210] incorporated by reference at paragraph [0045] and hereinafter referred to as Iliff’210 and Iliff [US 5,724,968] incorporated by reference at paragraph [0096] and hereinafter Iliff’968); Furusho [US 6,643,644]; and Qiao [US 2009/0100042 A1].
With regard to claim 42, Marchosky teaches a method of generating a ranked high probability differential medical diagnosis and confirming a ranked diagnosis comprising: collecting a first medical data from a patient; collecting a second medical data from the patient (see paragraphs [0025], [0037], [0068], and [0091]; the system can collect medical clinical data from a patient);
connecting the first medical data with the said differential diagnosis medical data; connecting the second medical data with the said differential diagnosis medical data; generating a listing of
linking one or more of diagnostic questions to the
providing a selection means to the user to answer the diagnostic questions (see paragraphs [0037] and [0063]; a user can use a computer to enter answers to the respective questions);
analyzing the answers to the diagnostic questions; and establishing a weight for each answer of the diagnostic questions, whereby a positive response to one of the diagnostic questions will be assigned a first weight and a negative response to one of the diagnostic questions will be assigned a second weight; adding up all of the weights assigned to the answers of the diagnosis questions to obtain a total sum (see paragraphs [0079]-[0080], [0050], [0037] and [0025]; the system reviews the answers to questions and utilizes the associated weights for the respective question and disease diagnosis as part of a summation process to determine an overall score for the respective potential disease).
Marchosky does not appear to explicitly teach:
accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data;
connecting the first medical data with the master differential diagnosis medical data tables; connecting the second medical data with the master differential diagnosis medical data tables;
isolating all disease data common to said master differential diagnosis medical data tables associated with said first medical data and said second medical data;
generating a listing of said isolated common disease data associated with said first medical data, and second medical data;
and arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data, and said second medical data;
linking one or more of diagnostic questions to the top ranked disease data, wherein the one or more diagnostic questions are specific to the selected diagnosis data;
establishing a threshold value to be assigned to the selected diagnosis data; comparing the threshold value assigned to the selected diagnosis data to the total sum of all of the weights;
and generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected disease data.
Iliff teaches accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data (see Iliff, paragraphs [0051] and [0109]; see Iliff’210, col 29, line 60 through col 30, line 59; Figure 27 and col 46, line 34 through col 47, line 22; the system can use disease objects that themselves include table of symptoms and other information for a particular disease object);
establishing a threshold value to be assigned to the selected diagnosis data (see Iliff968, col 39, lines 14- 18; Iliff’210, col 8, line 47; established threshold can be used to determine if the symptoms match the selected ranked disease/diagnosis);
comparing the threshold value assigned to the selected diagnosis data to the total sum of all of the weights; and generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected disease data (see Iliff, paragraphs [0109]-[0111]; lliff968, col 61, lines 20-31; see col 39, lines 13-27; see Iliff’210, col 17, line 49 through col 18, line 3; the system can sum up the weights associated with various questions to determine if the score exceeds the threshold to confirm a diagnosis).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky by utilizing data tables with medical and differential diagnosis information associated with various diseases and also be able to quickly determine potential diagnosis and provide information about a determined diagnosis based on threshold comparisons as taught by Iliff in order to be able to access and search/compare information for the various candidate diseases while also allowing for a modular system that allows any updates to occur locally for a particular disease object, such as change of weighting for symptom importance without having to change a single large table and also to allow multiple candidate disease diagnoses to be evaluated to determine a candidate diagnosis which will then prioritize questions to the user for that candidate disease diagnosis to quickly determine whether that candidate diagnosis should be the diagnosis for the patient/user.
Marchosky in view of Iliff teach connecting the first medical data with the master differential diagnosis medical data tables; connecting the second medical data with the master differential diagnosis medical data tables (see Iliff, paragraphs [0051] and [0109]; see Iliff’210, col 29, line 60 through col 30, line 59; Figure 27 and col 46, line 34 through col 47, line 22; the system can use disease objects that themselves include table of symptoms and other information for a particular disease object; see Marchosky, paragraphs [0091], [0099], and [0167]-[0180]; the system utilizes the questions and information about diseases to determine candidate diseases, i.e. isolating diseases common);
linking one or more of the diagnostic questions to the top ranked disease data, wherein the illustrated diagnostic questions are specific to the selected diagnosis data (see Marchosky, paragraph [0076]; see Iliff, Figure 8 and paragraphs [0111], [0103], and [0011]; questions are linked to particular disease diagnosis disease objects where a particular disease object will ask questions specific for that disease object, i.e. top ranked disease).
Marchosky in view of Iliff do not appear to explicitly teach:
isolating all disease data common to said master differential diagnosis medical data tables associated with said first medical data, and said second medical data;
generating a listing of said isolated common disease data associated with said first medical data, and second medical data;
and arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data, and said second medical data.
Furusho teaches isolating all data common to said data tables associated with said first data and said second data (see col 15, lines 5-12 and col 14, lines 30-35; the system can perform independent searches to form independent result sets that can be combined including the use of an AND that isolates all common results between the two sets).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff by incorporating means to individually search attributes and combine them together to form a common result set as taught by Furusho in order to allow for parallel processing of information where multiple threads can execute searches on each independent input symptom with means to combine the respective results in a manner to preserve the accuracy and integrity of the medical analysis system by being able to filter out outlier disease causes and focus on diseases associated with the respective input symptoms.
Marchosky in view of Iliff and Furusho teach isolating all disease data common to said master differential diagnosis medical data tables associated with said first medical data, and said second medical data; generating a listing of said isolated common disease data associated with said first medical data, and second medical data (see Furusho, col 15, lines 5-12 and col 14, lines 30-35; see Marchosky, paragraphs [0091], [0099], [0157], and [0176]-[0180]; the system can connect the medical clinical data to a database that stores various disease and other medical clinical data and compare perform differential comparisons that will isolate the potential disease data for each symptom individually and combine the common ones together where the common diseases are the ones that are common to the user’s first and second and third medical data which also makes that data common to each other grouping of first and second, first and third, and second and third groupings).
Marchosky in view of Iliff and Furusho do not appear to explicitly teach arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data, and said second medical data.
Qiao teaches arranging said
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff and Furusho by incorporating means to help determine respective results based on how many times the received input is present in the results as taught by Qiao in order to help distinguish/rank results that are deemed more relevant based on the increased usage of the desired user terms/criteria since results with little usage of those terms/criteria are more likely to be less relevant to the user than other results that use their desired terms/criteria frequently.
Marchosky in view of Iliff, Furusho, and Qiao teach arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data, and said second medical data (see Qiao, paragraph [0062] and [0064]; Furusho, col 15, lines 5-12 and col 14, lines 30-35; see Marchosky, paragraphs [0091], [0099], [0157], and [0176]-[0180]; the system can generate a ranked list of the candidate diseases/diagnosis that can take into account the description information of the diagnosis and the frequency of the user medical data/keywords/symptoms to determine which candidates are most likely or relevant to the user’s current situation/experiences).
With regard to claim 43, Marchosky in view of Iliff, Furusho, and Qiao teach ranking said disease data within said master differential diagnosis medical data table associated with said first medical data, whereby more prevalent disease data is ranked ahead of less prevalent disease data (see Marchosky, paragraphs [0099] and [0176]; see Iliff ‘210, col 32, lines 4-25; col 8, lines 30-42; the system can rank the diseases including more prevalent diseases ranked ahead of less prevalent).
With regard to claim 44, Marchosky in view of Iliff, Furusho, and Qiao teach arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the medical data that concerns said patient more instead of the first medical data (see Marchosky, paragraph [0093]; see Iliff ‘210, col 21, line 60 through col 22, line 3; col 32, lines 4-25; the system can incorporate pain severity level that indicates which symptom concerns the patient most where urgent and severe disease data can be ranked first ahead no matter the order from which the system receives the collected medical data of the user/patient).
With regard to claim 46, Marchosky in view of Iliff, Furusho, and Qiao teach wherein said generating data in response to said analyzed answers to said diagnostic questions comprises: analyzing said diagnosis confirmation signal and illustrating data to said user, wherein if said diagnosis confirmation signal is positive, said illustrated data will include treatment data related to said selected ranked disease data; and if said diagnosis confirmation signal is negative, said illustrated data will include data notifying a user that said selected ranked disease data is not a diagnosis (see Marchosky, paragraphs [0099] and [0157]; see Iliff, paragraphs [0102] and [0111]; see Iliff, ‘210, col 29, lines 57-60; the system can perform various iterative questions until a diagnosis is reached where the system can recommend or advise the user about treatment data associated with the disease diagnosis; if a diagnosis is not reached the system can notify the user by excluding that disease from list of potential diseases).
With regard to claim 47, Marchosky teaches a method of generating a ranked high probability differential medical diagnosis and confirming a ranked diagnosis comprising: collecting a first medical data from a patient; collecting a second medical data from the patient; collecting a third medical data from the patient (see paragraphs [0025], [0037], [0068], and [0091]; the system can collect medical clinical data from a patient);
connecting the first medical data with the said differential diagnosis medical data; connecting the second medical data with the said differential diagnosis medical data; connecting the third medical data with the said differential diagnosis medical data; generating a listing of common disease data (see paragraphs [0091], [0099], and [0167]-[0180]; the system can connect the medical clinical data to a database that stores various disease and other medical clinical data and compare perform differential comparisons that will isolate the potential disease data to ones that are common to the user’s first and second medical clinical data);
linking one or more of the diagnostic questions to the
providing a selection means to the user to answer the diagnostic questions (see paragraphs [0037] and [0063]; a user can use a computer to enter answers to the respective questions);
analyzing the answers to the diagnostic questions; and establishing a weight for each answer of the diagnostic questions, whereby a positive response to one of the diagnostic questions will be assigned a first weight and a negative response to one of the diagnostic questions will be assigned a second weight; adding up all of the weights assigned to the answers of the diagnosis questions to obtain a total sum (see paragraphs [0079]-[0080], [0050], [0037] and [0025]; the system reviews the answers to questions and utilizes the associated weights for the respective question and disease diagnosis as part of a summation process to determine an overall score for the respective potential disease).
Marchosky does not appear to explicitly teach:
accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data;
connecting the first medical data with the said master differential diagnosis medical data tables; connecting the second medical data with the said master differential diagnosis medical data; connecting the third medical data with the said master differential diagnosis medical data;
generating a listing of isolated common disease data associated with said first medical data, second medical data, and said third medical data;
arranging all of said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data table, said second medical data table, and said third medical data table;
linking one or more of diagnostic questions to the top ranked disease data, wherein the one or more diagnostic questions are specific to the selected diagnosis data;
establishing a threshold value to be assigned to the selected diagnosis data;
comparing the threshold value assigned to the selected diagnosis data to the total sum of all of the weights; and
generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected disease data.
Iliff teaches accessing master differential diagnosis medical data tables comprising a plurality of medical data and differential diagnosis data associated with said medical data (see Iliff, paragraphs [0051] and [0109]; see Iliff’210, col 29, line 60 through col 30, line 59; Figure 27 and col 46, line 34 through col 47, line 22; the system can use disease objects that themselves include table of symptoms and other information for a particular disease object);
establishing a threshold value to be assigned to the selected diagnosis data (see Iliff968, col 39, lines 14- 18; Iliff’210, col 8, line 47; established threshold can be used to determine if the symptoms match the selected ranked disease/diagnosis);
comparing the threshold value assigned to the selected diagnosis data to the total sum of all of the weights; and generating a diagnosis confirmation signal, such that the diagnosis confirmation signal is positive if the total sum equals or exceeds the threshold value assigned to the selected ranked disease data, and the diagnosis confirmation signal is negative if the total sum is lower than the threshold value assigned to the selected disease data (see Iliff, paragraphs [0109]-[0111]; lliff968, col 61, lines 20-31; see col 39, lines 13-27; see Iliff’210, col 17, line 49 through col 18, line 3; the system can sum up the weights associated with various questions to determine if the score exceeds the threshold to confirm a diagnosis).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky by utilizing data tables with medical and differential diagnosis information associated with various diseases and also be able to quickly determine potential diagnosis and provide information about a determined diagnosis based on threshold comparisons as taught by Iliff in order to be able to access and search/compare information for the various candidate diseases while also allowing for a modular system that allows any updates to occur locally for a particular disease object, such as change of weighting for symptom importance without having to change a single large table and also to allow multiple candidate disease diagnoses to be evaluated to determine a candidate diagnosis which will then prioritize questions to the user for that candidate disease diagnosis to quickly determine whether that candidate diagnosis should be the diagnosis for the patient/user.
Marchosky in view of Iliff teach connecting the first medical data with the said master differential diagnosis medical data tables; connecting the second medical data with the said master differential diagnosis medical data; connecting the third medical data with the said master differential diagnosis medical data (see Iliff, paragraphs [0051] and [0109]; see Iliff’210, col 29, line 60 through col 30, line 59; Figure 27 and col 46, line 34 through col 47, line 22; the system can use disease objects that themselves include table of symptoms and other information for a particular disease object; see Marchosky, paragraphs [0091], [0099], and [0167]-[0180]; the system utilizes the questions and information about diseases to determine candidate diseases, i.e. isolating diseases common);
linking one or more of diagnostic questions to the top ranked disease data, wherein the one or more diagnostic questions are specific to the selected diagnosis data (see Marchosky, paragraph [0076]; see Iliff, Figure 8 and paragraphs [0111], [0103], and [0011]; questions are linked to particular disease diagnosis disease objects where a particular disease object will ask questions specific for that disease object, i.e. top ranked disease).
Marchosky in view of Iliff do not appear to explicitly teach:
generating a listing of isolated common disease data associated with said first medical data, second medical data, and said third medical data;
arranging all of said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data table, said second medical data table, and said third medical data table.
Furusho teaches generating a listing of said isolated common
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff by incorporating means to individually search attributes and combine them together to form a common result set as taught by Furusho in order to allow for parallel processing of information where multiple threads can execute searches on each independent input symptom with means to combine the respective results in a manner to preserve the accuracy and integrity of the medical analysis system by being able to filter out outlier disease causes and focus on diseases associated with the respective input symptoms.
Marchosky in view of Iliff and Furusho teach generating a listing of isolated common disease data associated with said first medical data, second medical data, and said third medical data (see Furusho, col 15, lines 5-12 and col 14, lines 30-35; see Marchosky, paragraphs [0091], [0099], [0157], and [0176]-[0180]; the system can connect the medical clinical data to a database that stores various disease and other medical clinical data and compare perform differential comparisons that will isolate the potential disease data for each symptom individually and combine the common ones together where the common diseases are the ones that are common to the user’s first and second and third medical data which also makes that data common to each other grouping of first and second, first and third, and second and third groupings).
Marchosky in view of Iliff and Furusho do not appear to explicitly teach arranging all of said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data table, said second medical data table, and said third medical data table.
Qiao teaches arranging said system can help determine a ranking based on the number of times the respective keywords or respective first and second data are found in the results).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical analysis system of Marchosky in view of Iliff and Furusho by incorporating means to help determine respective results based on how many times the received input is present in the results as taught by Qiao in order to help distinguish/rank results that are deemed more relevant based on the increased usage of the desired user terms/criteria since results with little usage of those terms/criteria are more likely to be less relevant to the user than other results that use their desired terms/criteria frequently.
Marchosky in view of Iliff, Furusho, and Qiao teach arranging all of said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the number of times said disease data is associated with said first medical data table, said second medical data table, and said third medical data table (see Qiao, paragraph [0062] and [0064]; Furusho, col 15, lines 5-12 and col 14, lines 30-35; see Marchosky, paragraphs [0091], [0099], [0157], and [0176]-[0180]; the system can generate a ranked list of the candidate diseases/diagnosis that can take into account the description information of the diagnosis and the frequency of the user medical data/keywords/symptoms to determine which candidates are most likely or relevant to the user’s current situation/experiences).
With regard to claim 48, Marchosky in view of Iliff, Furusho, and Qiao teach wherein said generating data in response to said analyzed answers to said diagnostic questions comprises: analyzing said diagnosis confirmation signal and illustrating data to said user, wherein if said diagnosis confirmation signal is positive, said illustrated data will include treatment data related to said selected ranked disease data; and if said diagnosis confirmation signal is negative, said illustrated data will include data notifying a user that said selected ranked disease data is not a diagnosis (see Marchosky, paragraphs [0099] and [0157]; see Iliff, paragraphs [0102] and [0111]; see Iliff, ‘210, col 29, lines 57-60; the system can perform various iterative questions until a diagnosis is reached where the system can recommend or advise the user about treatment data associated with the disease diagnosis; if a diagnosis is not reached the system can notify the user by excluding that disease from list of potential diseases).
With regard to claim 49, Marchosky in view of Iliff, Furusho, and Qiao teach ranking said disease data within said master differential diagnosis medical data table associated with said first medical data, whereby more prevalent disease data is ranked ahead of less prevalent disease data (see Marchosky, paragraphs [0099] and [0176]; see Iliff ‘210, col 32, lines 4-25; col 8, lines 30-42; the system can rank the diseases including more prevalent diseases ranked ahead of less prevalent).
With regard to claim 50, Marchosky in view of Iliff, Furusho, and Qiao teach arranging said isolated common disease data in said generated listing in a ranked order, whereby the position in said ranked listing is based upon the medical data that concerns said patient more instead of the first medical data (see Marchosky, paragraph [0093]; see Iliff ‘210, col 21, line 60 through col 22, line 3; col 32, lines 4-25; the system can incorporate pain severity level that indicates which symptom concerns the patient most where urgent and severe disease data can be ranked first ahead no matter the order from which the system receives the collected medical data of the user/patient).
With regard to claim 52, Marchosky in view of Iliff, Furusho, and Qiao teach ranking said disease data within said differential diagnosis medical data table associated with said second medical data whereby more prevalent disease data is ranked ahead of less prevalent disease data (see Marchosky, paragraphs [0099] and [0176]; see Iliff ‘210, col 32, lines 4-25; col 8, lines 30-42; the system can rank the diseases including more prevalent diseases ranked ahead of less prevalent).
Allowable Subject Matter
Claims 53-57 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 45 and 51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 45 and 51 recite particular steps associated with how the data interrelates with each other and that association for ranking the various items for the user. As shown in the 35 USC 103 rejections above, the combination of the cited prior art references teach or fairly suggest various limitations including merging results and various sorting/ordering techniques but do not appear to perform the same ranking steps as recited in the claims.
Claim 53 and 56 recite similar limitations as that of claims 45 and 51 and for similar reasons as discussed above, those claims are allowable over the prior art of record. Claims 54-55 and 57 depend upon claims 53 and 56 and are allowable for similar reasons as their parent independent claim.
Terminal Disclaimer
The terminal disclaimer filed on 8/4/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11972865 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments (see the first paragraph on page 23 through page 32) have been fully considered but they are not persuasive. The applicant argues that the claimed invention cannot be performed mentally or manually since the claim is directed to specific, structured, and technological improvement to diagnostic workflows that mimic expert-level clinical reasoning by mathematically modelling diagnostic strategies using weighted symptom scoring and diagnostic cut-off thresholds. The Examiner respectfully disagrees. As part of the arguments, the applicant’s arguments indicate that the invention requires computer implementation due to the volume and variability of data (see page 23 and section 5 on page 30); however, such requirements are intended usage arguments since the claims do not recite nor require such volume of data under the broadest reasonable interpretation of the claim scope. Additionally, (see pages 24-27) the applicant indicates that the invention addresses diagnostic errors from limited physician experiences and how the system replicates expert diagnostic process via assigning heuristically derived diagnostic weights and being able to switch between reasoning or pattern recognition to finish diagnostic workup quickly and efficiently via diagnosis-specific models; however, as noted in the 35 USC 101 rejections above, the analysis/reasoning steps recite din the claim are at a high-level of generality and relate to mental process steps. As such, applicant’s arguments are not persuasive.
Applicant also argues (see end of page 27 through page 28 and last bullet on page 29) about the cost-effectiveness; however, as noted above, the claims recite limitations at a high-level of generality with no specific limitation identified that relate to the above argument. Although the limitations are meant to be cost-effective, merely performing limitations at a high-level of generality and indicating that their usage provides the intended benefit of cost-effectiveness is not convincing since there no specific or particular details to illustrate that alleged benefit.
With regard to applicant’s arguments (all the above arguments and additional ones up to page 32) regarding an improvement to the functioning of a computer or to any other technology or technical field, the Examiner notes that, per MPEP 2106.05(a), that “[a]n important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107.” (emphasis added). Additionally, it is important to note that “the judicial exception alone cannot provide the improvement” and that “the claim reflects the asserted improvement”. As indicated above, the respective claims recite the claims at a high-level of generality with the majority of the above noted limitations being recited as part of the judicial exception. As such, applicant’s arguments are not persuasive and the respective 35 USC 101 rejections still stand.
Applicant’s arguments (see section I on page 37) with respect to claim objections have been fully considered and are persuasive. The objections of the claims have been withdrawn. The applicant amended the claims to address the previous claim objections. In view of the amendments, the respective previous objections have been withdrawn.
Applicant's arguments (see section II starting on page 37) have been fully considered but they are not persuasive. The applicant argues that the amendments address the 35 USC 112 rejections. Although various amendments were made that addressed the 35 USC 112 rejections; as noted above, the new limitations resulted in new 35 USC 112 rejections occurring and thus various claims are still rejected under 35 USC 112.
Applicant's arguments (see second paragraph on page 38 through top of page 42) have been fully considered but they are not persuasive. The applicant argues (a) that the claims are not directed to an abstract idea (see arguments on page 38) since the invention requires high-dimensional data processing involving “30,000-40,000 clinical feature associations” and disease-specific weighting which are “not realistically executable without computer assistance”; (b) that the claims are integrated into a practical application for reasons similar to McRo with rules and numeric weighting and recite a technological improvement to diagnostic safety and accuracy (see section B on page 39); (c) that the claims are significantly more since applicant’s system is not a generic implementation with the data structures and diagnostic threshold improve clinical workflow efficiency and diagnostic reliability (see section C starting on page 39 through page 40); (d) that the limitation of assigning weights to symptoms and calculating a score is not universal or purely mathematical and that the claimed system prevents mental application due to its scale and variability and is impossible for any person to memorize or mentally process (see section D starting on page 40 through second paragraph on page 41); and (e) the applicant argues that the claims are similar to BASCOM and should be eligible for similar rationale (see section E on page 41 through top of page 42).
The Examiner respectfully disagrees.
With regard to argument (a), the Examiner notes that the features which applicant relies upon (the size of the data) is not explicitly recited in the claim and that the claim scope covers a broader range. Also, per MPEP 2106.04(a)(2)(III)(C), claims that require a computer a computer may still recite a mental process, such as using the computer as a tool to perform a mental process. Therefore, applicant’s arguments are not persuasive.
With regard to argument (b), there is no clear indication as to the similarity of the facts of McRO with that of the instant claim limitations. As noted in the 35 USC 101 rejections above, the respective claims are at a high-level of generality of performing mental process steps that involve practices from the “pre-Internet world”; with no discussion in the claims of the ‘specific framework’ that is utilized by the claims. Therefore, due to the high-level of generality of the claim limitations and also in view of the various claim limitations being directed to mental process steps as discussed above, the applicant’s arguments are not persuasive. Further, as noted in the 35 USC 101 rejections, the additional elements add no meaningful limitation beyond that of the abstract idea since those limitations relate to data communication steps at a high-level of generality (receiving/transmitting/presenting information); as such, applicant’s arguments are not persuasive.
With regard to argument (c), the Examiner notes that, e.g. claim 1, no specific framework or data structures are discussed and that the additional elements alone merely indicate receiving or transmitting information with no specific implementation details. As such, applicant’s arguments are not persuasive.
With regard to argument (d), although applicant intends for large scale application of data features, the claim scope is not so limited. Additionally, as discussed above, the respective claim limitations recite functionality at a high-level of generality that involve mental process steps. As noted in MPEP 2106.04(a)(2)(III)(C), claims requiring the usage of a computer can still recite mental process steps. Thus, applicant’s arguments are not persuasive.
With regard to argument (e), the Examiner notes that applicant provided vague generalizations of the similarities between the two cases; however, a review of the BASCOM decision shows noticeable differences between the facts of the two underlying cases and doesn’t seem relevant to the current claims (which as noted above are recited at a high-level of generality). With regard to applicant’s arguments regarding an improvement to the functioning of a computer or to any other technology or technical field, the Examiner notes that, per MPEP 2106.05(a), that “[a]n important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107.” (emphasis added). Additionally, it is important to note that “the judicial exception alone cannot provide the improvement” and that “the claim reflects the asserted improvement”. The extent that the claims cover a particular solution is an important consideration, where, as discussed above, the claims recite various limitations in higher-level of generality including assigning weights and comparing score values. Therefore, in view of MPEP 2106.05(a), applicant’s arguments are not persuasive.
Applicant's arguments (see section IV on page 42 through the first whole paragraph on page 44) with respect to the 35 USC 102 rejections by Iliff have been fully considered and are persuasive. The 35 USC 102 rejections of the claims by Iliff has been withdrawn. The applicant amended the claims in a manner that differentiated the claims from the teachings of the prior art.
Applicant's arguments (see section V on page 44 through last paragraph on page 44) have been fully considered but they are not persuasive. The applicant argues that the Becker reference does not teach hand-written inputs. The Examiner respectfully disagrees. The applicant argues (see second to last paragraph on page 44) that “[i]n contrast, the claimed system allows a user to input hand-written medical orders using devices such as an electronic pen or touch screen…” which differs from Beckers “processing electronic or typed medical orders…not hand-written inputs”. As mentioned in the 35 USC 102 rejections, the Becker reference teaches at paragraph [0109] the ability for input to be provided with a stylus. Additionally, paragraph [0078] indicates that when using a handheld device, the clinician/user can have a device with a touch screen (paragraph [0050] discusses a stylus too) for the ability of the device to perform handwriting image capture. Therefore, as can be seen, the prior art reference does provide means for handwritten inputs.
Applicant's arguments (see first paragraph on page 45 through last paragraph on page 45 with respect to the 35 USC 102) have been fully considered but they are not persuasive. The applicant argues that the cited prior art does not teach the respective claim limitations of claim 37 for similar reasons as discussed above. As noted by the Examiner, the Becker reference provides various means of input including touch screen, stylus and electronic pen (paragraph [0106]) where various paragraphs including paragraph [0078] as discussed in the 35 USC 102 rejection includes “cognitive handwriting recognition” and image handwriting capture. Paragraph 144 of Becker even indicates it can use character recognition. Therefore, as can be seen, the prior art teaches the claim limitations as recited and can utilize numerous different means of receiving input including via handwriting and has recognition means for the handwriting.
Applicant's arguments (see the last paragraph on page 45 through last paragraph on page 47) have been fully considered but they are not persuasive. The applicant argues that the 35 USC 103 rejections involving Marchosky and Iliff should be withdrawn since (a) the cited prior art fail to teach diagnostic-specific weighting logic; (b) no disclosure of expert-level diagnostic logic; (c) no motivation to combine references as claimed; and (d) claimed inventions solve a different problem from prior art. The Examiner respectfully disagrees.
With regard to arguments (a) and (b), the applicant argues that the cited prior art doesn’t assign unique weights per symptom-disease pair, applies inverted scoring logic, utilizes cut-off thresholds calibrated per disease, and cut-off thresholds dynamically set. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., applies inverted logic, assign unique weights per symptom-disease pair, cut-off threshold calibrated per disease, and cut-off threshold dynamically set; and expert-level diagnostic logic) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Although the claim 1 recites concepts similar to the above noted features, the level of detail in the arguments versus what is presented in the claims differ. Additionally, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As such, in view of the broadest reasonable interpretation of the claims, the teachings of the cited prior art teach, or fairly suggest the claim limitations as recited as discussed in the 35 USC 103 rejections above.
With regard to argument (c) about the motivation argument, the applicant argues that the combination is hindsight driven. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As illustrated in the 35 USC 103 rejections, an articulated reason was provided for the combination where it was noted that the Marchosky reference discussed desire for the system to be able to be an automated diagnosis system; however, Marchosky’s output appears to focus on the ranking of potential diagnoses and not providing an explicit answer where Iliff’s automated means of object-oriented programming makes use of different diseases to be able to determine a diagnosis with associations of the questions with disease objects and associated weights and thresholds thus improving upon the question/answer system of Marchosky by focusing on particular diseases to achieve a correct diagnosis with as few questions as possible with the threshold evaluation being a means for determining if the disease object should be the diagnosis or if it is still relevant for consideration based on user responses (see Iliff, paragraphs 47-49).
With regard to argument (d) about the problem of reducing diagnostic error, the cited prior art references perform actions similar to the claim limitations where there is no particular limitation (in at least claim 1 and many other independent claims) discussing diagnostic error or means to reduce such error. If it is assumed that the disclosed claim steps achieve such a goal, then the cited prior art references also achieve such goal for performing similar actions in their medical diagnosis process steps. Therefore, since the cited prior art references teach the claim limitations as recited and desire to have accurate and correct diagnoses for patients, the cited prior art references are related and address applicant’s stated problem via automated diagnosis means including calculations with weights for answers and symptoms.
Applicant's arguments (see the section C starting on the first paragraph on page 48) have been fully considered but they are not persuasive. The applicant argues that the Papageorge reference is not directed to weighted clinical scoring that assign weights to clinical data and uses scoring models to compare the weights to dynamic thresholds. The Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As illustrated in the 35 USC 103 rejections, the Papageorge reference’s teachings of utilizing score to determine a severity level of the disease for a patient is combined with the teachings of Marchosky and Iliff which teaches the assigning weights aspects as discussed above. Therefore, in view of the combination of references, the respective combination teaches the claim limitations as recited.
Applicant's arguments (see section D starting on page 48) have been fully considered but they are not persuasive. The applicant discusses secondary considerations including system being successfully deployed; diagnostic reading being improved and confirmed by empirical results; and no system in the art enables scalable expert-level diagnosis for novice technicians using purely digital mathematical logic which supports non-obviousness due to commercial success, long-felt but unmet need, and failure of others. This argument appears to coincide with the 132 Affidavit filed on 7/10/2025 with the Examiner relying upon such Affidavit as the supporting evidence.
With regard to the commercial success argument, per MPEP 716.03(a):
“In order to be commensurate in scope with the claims, the commercial success must be due to claimed features, and not due to unclaimed features.”; and
“An affidavit or declaration attributing commercial success to a product or process "constructed according to the disclosure and claims of [the] patent application" or other equivalent language does not establish a nexus between the claimed invention and the commercial success because there is no evidence that the product or process which has been sold corresponds to the claimed invention, or that whatever commercial success may have occurred is attributable to the product or process defined by the claims. Ex parte Standish, 10 USPQ2d 1454, 1458 (Bd. Pat. App. & Inter. 1988).”
In view of the burden required, applicant’s arguments are not persuasive since it is unclear what features are most important or utilized and whether that is due to the claimed features or disclosed specification. Additionally, with regards to the prior art, the Examiner notes that at least the Iliff reference discloses weighted features with adding and subtracting weights associated (Iliff’210 Figure 27 shows a disease-symptom matrix with positive and negative weights) with symptoms/diseases which is compared to disease thresholds. Thus, the prior art does teach elements associated with the claimed invention (see affidavit, bullet 8).
With regard to long-felt need and failure of others, pe MPEP 714.01(I):
“Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967) ("Since the alleged problem in this case was first recognized by appellants, and others apparently have not yet become aware of its existence, it goes without saying that there could not possibly be any evidence of either a long felt need in the . . . art for a solution to a problem of dubious existence or failure of others skilled in the art who unsuccessfully attempted to solve a problem of which they were not aware."); Orthopedic Equipment Co., Inc. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 217 USPQ 1281 (Fed. Cir. 1983) (Although the claimed invention achieved the desirable result of reducing inventories, there was no evidence of any prior unsuccessful attempts to do so.).
Second, the long-felt need must not have been satisfied by another before the invention by the inventor. Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988) (Although at one time there was a long-felt need for a "do-it-yourself" window shade material which was adjustable without the use of tools, a prior art product fulfilled the need by using a scored plastic material which could be torn. "[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved".)
Third, the invention must in fact satisfy the long-felt need. In re Cavanagh, 436 F.2d 491, 168 USPQ 466 (CCPA 1971).”
With regard to long-felt need and failure of others, as noted above there are various factors to consider. Part of the first factors deals with art recognized problem that existed for a long time without a solution. Although the specification may have additional details, the claims recite limitations at a broader level where, as discussed above, various cited prior art references including Iliff discuss the usage of weights assigned to symptoms/diseases and using thresholds for diseases to determine a diagnosis. Therefore, applicant’s arguments are not persuasive.
Applicant's arguments (see the first whole paragraph on page 49 through the last paragraph on page 50) have been fully considered but they are not persuasive. The applicant argues that the Marchosky reference does not disclose diagnosis-specific diagnostic questions or utilizing response-dependent weighting score to compute diagnostic-specific score nor compare that score to a threshold where Iliff does not disclose targeted questions to each diagnosis, nor calculating a score based on answer weighting and comparing to a threshold value to generate a binary confirmation signal. Additionally, applicant argues on page 50 that the cited references fail to provide any teaching or motivation for the stepwise fallback logic which involves repetition of diagnostic question/answering, weighting and score summation, et cetera. The Examiner respectfully disagrees.
With regards to the prior art teachings argument, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As illustrated in the 35 USC 103 rejections the cited prior art (including Iliff) teach questions associated with the disease/diagnosis as well as weighting answers including means for determining a diagnosis (see mapping for Iliff’968). Therefore, as discussed in the 35 USC 103 rejections, the cited prior art references teach the claim limitations as recited. With regard to the motivation, although the Office Action did not provide a discussion of repeating the diagnosis process, the Examiner notes that no such limitation is in claim 1 thus arguments about not discussing such a feature are not persuasive.
Applicant's arguments (see the first paragraph on page 51 through the second to last paragraph on page 51) have been fully considered but they are not persuasive. The applicant argues that the Papageorge reference does not teach the above discussed features. The Examiner respectfully disagrees. As discussed above, the cited prior art references teach the claim limitations therefore applicant’s arguments are not persuasive.
Applicant's arguments (see the last paragraph on page 51) have been fully considered but they are not persuasive. The applicant argues that the other dependent claims are non-obvious for reasons discussed above as well as for their own respective claim limitations. The Examiner respectfully disagrees. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. For at least the reasons discussed above and in the 35 USC 103 rejections, the respective dependent claims stand rejected.
Applicant's arguments (see the first whole paragraph on page 52 through the second paragraph on page 53) have been fully considered but they are not persuasive. The applicant argues that the various dependent claims recite various features that are not taught by the cited prior art references. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments (see third paragraph on page 53 through the third from last paragraph on page 56) have been fully considered but they are not persuasive. The applicant argues that the other cited prior art references do not cure the deficiencies of Marchosky and Iliff with respect to the teachings of features of the independent claim. The Examiner respectfully disagrees. As discussed above, the cited prior art references teach the claim limitations as recited therefore, applicant’s arguments are not persuasive and the respective rejections of the dependent claims still stand.
Applicant's arguments (see the second to last paragraph on page 56 through the second to last paragraph on page 57) have been fully considered but they are not persuasive. The applicant argues that (i) Becker does not teach the limitations of claim 32 and that Marchosky does not remedy those deficiencies. Additionally the applicant argues that (ii) the references do not disclose storing previously transmitted orders or logic to verify medical order before transmission and (iii) that any combination of the cited prior art is based on impermissible hindsight. The Examiner respectfully disagrees.
With regard to argument (i), as discussed above the Becker reference teaches the claim limitations as recited. Therefore, applicant’s arguments are not persuasive in view of the 35 USC 102 rejection above and the above discussion for the respective claim.
With regard to argument (ii), with regard to previously transmitted orders and verify medical orders limitations, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As illustrated in Marchosky, medical history information or records of the user/patient can be stored including information related to tests, results, and prescribed medicine (i.e. prescription orders). As such, the combination teaches the claim limitations as recited. With regard to the claim 41 argument, the Examiner notes that no such limitation exists. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., verify medical order before transmission) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, the combination teaches the claim limitations as recited and the respective rejections still stand.
With regard to (iii), in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Marchosky teaches various information that can be included as part of a person’s medical history where Becker did not appear to explicitly indicate what was included in the medical records/history of a patient. Such incorporation of the information was not gleaned only from applicant’s disclosure since Marchosky provides suggestions including, but not limited to, providing a legal documentation history of patient’s conditions and treatments.
Applicant's arguments (see the last paragraph on page 57 through the first paragraph on page 59) have been fully considered but they are not persuasive. The applicant argues that, with respect to claim 42, the Marchosky reference does not teach ranking common differential diagnoses based on co-occurrence across multiple clinical data inputs; Iliff does not teach confirming diagnoses via response-weighted questioning and threshold comparison; Furusho lacks any teaching related to ranking/validating diagnoses; and Qiao provides no mechanism for probabilistic ranking or confirmatory scoring. The Examiner respectively disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Although various limitations are not taught by a particular reference, the Examiner notes that the 35 USC 103 rejections rely upon the teachings of the combination of references, e.g. with regards to Marchosky, Furusho, and Qiao arguments, the 35 USC 103 rejections rely upon the teachings of the combination including Marchosky and Qiao, which illustrates ranking based off of the frequency particular information is associated with one of the ranked results (candidates). With respect to Iliff, as discussed above, Iliff does teach response weighting questioning as well as doing comparisons to thresholds, thus applicant's arguments with respect to Iliff fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments (see the second paragraph on page 59 through the top of page 60) have been fully considered but they are not persuasive. The applicant argues that claim 47 includes 3 distinct medical data inputs and that none of the prior art references teach this level of multi-source triangulated diagnosis generation associated with three patient data sources to a diagnostic scoring engine. The Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., link three patient data sources to a dynamic diagnostic scoring engine; three distinct patient input sources) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As illustrated in the 35 USC 103 rejections, the system has multiple means of acquiring input data (medical data) that is used for diagnosis generation. Additionally with regard to Furusho and Qiao failing to disclose three distinct patient input data sources being cross-referenced to a differential diagnosis database, applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As such, applicant’s arguments are not persuasive and the respective rejections still stand.
Applicant's arguments (see the second and third paragraphs on page 60) have been fully considered but they are not persuasive. The applicant argues that the other rejections for the dependent claims from claim 42 and 47 should be non-obvious for the reasons discussed above with respect to claims 42 and 47. The Examiner respectfully disagrees. As discussed above, the cited prior art references teach the claim limitations of claims 42 and 47 therefore, the respective rejections of the dependent claims still stand.
Applicant’s arguments (see third from last paragraph on page 60 through last paragraph on page 61) with respect to the Double Patenting rejections have been fully considered and are persuasive. The Double Patenting rejections of the claims have been withdrawn. The applicant filed a Terminal Disclaimer; therefore, in view of the Terminal Disclaimer, the respective rejections have been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC S SOMERS whose telephone number is (571)270-3567. The examiner can normally be reached M-F 11-8 EST.
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/MARC S SOMERS/Primary Examiner, Art Unit 2159 2/6/2026