DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
In the response dated April 6th, 2026, Applicant amended claims 1-20. Claims 1-20 are pending.
Priority
Acknowledgment is made of applicant’s claim for priority. The current application claims benefit of provisional application 63/187,783, filed on May 12th, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 10th, 2023 is being considered by the examiner.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
Regarding page 11, Applicant’s arguments have been considered but are moot in view of the amended claim language.
Regarding pages 11-12, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the steps cannot practically be performed in the human mind because the system requires the automated processing of complex and high-volume EHR files. The Examiner respectfully disagrees. MPEP 2106.04(a)(2)(III)(A) states that a claimed invention is directed to a mental process if the identified claim elements contain limitations that the human mind is equipped to perform. Abstract ideas that have been held to be practically performable in the human mind include collection/analysis of data and collection/comparison of data. The Examiner submits that Applicant’s claims fall within the mental process grouping of abstract ideas and the Applicant has not identified anything in the claim invention that cannot be practically performed in the human mind. For instance, a human can access a computer comprising thousands of health records and parse out which record contains a specific patient. Furthermore, the Applicant argues that the claim requires automatic processing of large volumes of data; however, this is not reflected in the claim. The claim requires no specific amounts of data. The claims do not recite any automatic processing of information in a closed-loop manner. The Examiner submits that a human mind is capable of manipulating noisy data. Because the identified features of the claim can be practically performed in the human mind, the claims are directed to an abstract idea.
Regarding pages 13 and 14, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the claims improve the functioning of a computer in a meaningful way. The Examiner respectfully disagrees. MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer. See also MPEP 2106.05(a)(I). The technological environment of Applicant’s claim does not limit the scope to specialized computers but rather encompass general-purpose computer equivalents (see Spec. Para. [0195]). The Examiner cannot locate any physical improvement to the functioning of the computer that results from the implementation of Applicant’s claim. There is no indication that the computer is made to run faster, more efficiently, or utilize less power. In fact, the computer may be caused to operate slower and less efficiently through the implementation of Applicant’s claimed invention; we do not know. Because there is no improvement to the function of the computer, a practical application is not present.
Regarding pages 14-15, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the claims solve a technical problem of processing noisy assessment data. The Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem is not a technological problem caused by the hospital EMR’s system. The problem of healthcare providers incorrectly inputting inaccurate information was not a problem cause by the computer is it a problem that existed and/or exists regardless of whether a computer is involved in the process. At best, Applicant’s identified problem is a training problem. Because no technological problem is present, the claims do not provide a practical application. Regarding page 15, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the system effects a transformation of a particular article into a different state. The Examiner respectfully disagrees. MPEP 2106.04(d)(2) indicates that a practical application may be present where the claimed invention effects a transformation or reduction of a particular article to a different state or thing. MPEP 2106.05(c) thereafter describes that a transformation is present where a physical object or substance is transformed to a different state or thing. Notably, the mere manipulation of data has been deemed not to be a transformation within the meaning of the term “transformation.” Because no transformation is present in Applicant’s claimed invention, a practical application is not present.
Regarding page 16, Applicant’s arguments have been considered but are moot in view of the amended claim language.
Regarding page 17, Applicant’s arguments have been considered but are moot in view of the amended claim language.
Regarding page 17, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the prior art of record does not teach extracting data from unfiltered records, distribution of data, signal-processing derivative, or applying a threshold. MPEP 2111 states that the claims must be given the broadest reasonable interpretation in light of the specification. Applicant’s arguments, in part, rely upon language that is not cited in the claims. For instance, signal-processing derivative does not appear in the claims. Examiner maintains that the cited prior art of record teaches the claim limitation as written. For the purposes of applying art to the amended claims, these claim limitations may also be rejected under and mapped out to different prior art.
Regarding pages 18-19, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that examiner uses improper hindsight and contains a lack of motivation to combine. Examiner respectfully disagrees. MPEP 2143(I) discloses basic requirements for a Prima Facie case of obviousness may include “Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” As indicated before, Francois would have indicated the importance of medical record integration. “Patients may have multiple medical records generated at different medical facilities at which they have received care… problematic features of traditional medical records is the use of handwriting by health care providers, which may at times be difficult to decipher””, see [0001]. This strong motivation would have supported people having ordinary skill in the art, like Piani Meier, to have integrated Francois’s alert system to Piani Meier’s MS progression detection tool with a reasonable expectation of success. This would have improved a patient’s quality of care as they progress through stages of multiple sclerosis with more timely diagnosis and treatment options. Francois is adaptable to Piani Meier as both inventions utilize generic computer components to access electronic health record diagnostic tools to determine a patient’s neurological disease state. Therefore, Examiner maintains that the art of record cites motivations to combine without hindsight reasoning.
Claim Objections
Claim 15 is objected to because of the following informalities: “that” located in claim 15’s “in response to inferring that the one or more types of the multiple sclerosis” appears to be a clerical error. Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1
The claims recite subject matter within a statutory category as a process, machine, and/or article of manufacture. However, it will be shown in the following steps, that claims 1-20 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One
Claim 11 states:
A computer-implemented method comprising:
accessing one or more electronic health records (EHRs) comprising noisy assessment records associated with a subject, wherein the subject has been diagnosed with multiple sclerosis, wherein each noisy assessment record of the noisy assessment records is an electronic file comprising content originating from a device of a care provider that identifies an assessment of the subject, and wherein the assessment comprises a characteristic of the subject or of a treatment for the subject
extracting, from the one or more EHRs, a set of code instances within a defined time period, wherein each of the set of code instances indicates that a code of a set of codes was detected within the noisy assessment record
inferring the one or more types of the multiple sclerosis that correspond to the subject within the defined time period based on the set of code instances;
determining a temporal dynamic or distribution for the subject based on the set of code instances within the defined time period;
determining a modulation for the subject based on the temporal dynamic or the distribution;
determining whether an alert criterion is satisfied based on whether the modulation is above a threshold so as to represent noise or a predicted transition across types of multiple sclerosis;
outputting the one or more types of multiple sclerosis; and
when the alert criterion is satisfied:
generating an alert; and
outputting the alert.
The broadest reasonable interpretation of these steps includes mental processes and/or organizing human activity because each bolded component can practically be performed by the human mind or with pen and paper. Other than reciting generic computer terms like “computer-implemented”, nothing in the claims precludes the bold-font portions from practically being performed in the mind. For example, but for the “computer-implemented” language, “inferring a type of multiple sclerosis that corresponds to the subject and the defined time period based on the set of code instances” in the context of this claim encompasses a mental process of a healthcare professional determining the likelihood of a patient’s symptoms depicting primary multiple sclerosis. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” or “Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. Therefore:
inferring the one or more types of the multiple sclerosis that correspond to the subject within the defined time period based on the set of code instances;
determining a temporal dynamic or distribution for the subject based on the set of code instances within the defined time period;
determining a modulation for the subject based on the temporal dynamic or the distribution;
determining whether an alert criterion is satisfied based on whether the modulation is above a threshold so as to represent noise or a predicted transition across types of multiple sclerosis;
as drafted, could lay out a diagnostician overviewing a patient’s medical history to detail a differential diagnosis using medical codes that will be shared with a patient and, under the broadest reasonable interpretation, these steps include a mental process as an abstract idea.
Independent claims 1 and 20 cover similar steps of selecting codes withing a defined time period, inferring multiple sclerosis corresponding to the subject, determining a distribution based on the set of code instances, determining a modulation based on the distribution, generating an alert, and outputting an alert. These claims fall under the same category of an abstract idea and follows the same rationale as claim 11.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 15, reciting particular aspects of how “in response to inferring that the type of multiple sclerosis corresponds to the subject and the defined time period: inferring that the type of multiple sclerosis corresponds to the subject and another later time period that is subsequent to the defined time period” may be performed in the mind but for recitation of generic computer components).
Dependent claims 3, 4, 12, 13, and 14 add additional elements to their parent claims which will be further inspected in the following steps for a practical application to their abstract idea.
Step 2A Prong Two
This judicial exception of “Mental Processes” or “Organizing Human Activity” is not integrated into a practical application. Independent claim 11’s method recites additional elements such as a computer. In addition to the generic components and additional elements listed above, independent claim 1’s system and claim 20’s product also includes a non-transitory machine readable storage medium. The non-transitory machine readable storage medium will be treated as a generic computer components. In particular, these additional elements do not integrate the abstract idea into a practical application because the additional elements:
amount to mere instructions to apply an exception (such as recitation of “a computer implemented method” amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of “accessing one or more electronic health records (EHRs) comprising noisy assessment records associated with a subject, wherein the subject has been diagnosed with multiple sclerosis, wherein each noisy assessment record of the noisy assessment records is an electronic file comprising content originating from a device of a care provider that identifies an assessment of the subject, and wherein the assessment comprises a characteristic of the subject or of a treatment for the subject” and “extracting, from the one or more EHRs, a set of code instances within a defined time period, wherein each of the set of code instances indicates that a code of a set of codes was detected within the noisy assessment record” and “outputting the inferred type of multiple sclerosis” and “when the alert criterion is satisfied: generating an alert; and outputting the alert.” amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Additionally, claim 3 and 16’s “wherein inferring that the type of multiple sclerosis corresponds to the subject and the defined time period includes: detecting that the subject was inferred to have had another type of multiple sclerosis during another time period that was before the defined time period; retrieving a type criterion associated with a previous inference of the other type of multiple sclerosis; determining, based on the set of code instances, that the type criterion is not satisfied; in response to determining that the type criterion is not satisfied, evaluating another type criterion using the set of code instances; determining that the other type criterion is satisfied; and determining that the type of multiple sclerosis is associated with the other type criterion.” and claim 4 and 17’s “wherein inferring that the type of multiple sclerosis corresponds to the subject and the defined time period includes: detecting that the subject was inferred to have had another type of multiple sclerosis during another time period that was before the defined time period; retrieving a type criterion associated with a previous inference of the other type of multiple sclerosis; determining, based on the set of code instances, that the type criterion is not satisfied; in response to determining that the type criterion is not satisfied, iteratively evaluating each of multiple other type criteria until one of the multiple other type criteria is satisfied; and determining that the type of multiple sclerosis is associated with the one of the multiple other type criteria that is satisfied.” and claim 12 “selecting a treatment for the subject based on the inferred type of multiple sclerosis.” and claim 13 “predicting that the subject is eligible for a clinical study based in part on the inferred type of multiple sclerosis.” and claim 14 “assigning the subject to a cohort of a clinical study based at least in part on the inferred type of multiple sclerosis” amounts to insignificant application, see MPEP 2106.05(g)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The remaining dependent claims 2, 5-10, and 15-19 do not recite additional elements or activity but further narrow or define the abstract idea embodied in the claims and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. Additionally, the additional limitations, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
To elaborate:
“accessing one or more electronic health records (EHRs) comprising noisy assessment records associated with a subject, wherein the subject has been diagnosed with multiple sclerosis, wherein each noisy assessment record of the noisy assessment records is an electronic file comprising content originating from a device of a care provider that identifies an assessment of the subject, and wherein the assessment comprises a characteristic of the subject or of a treatment for the subject” is equivalently, electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii);
“extracting, from the one or more EHRs, a set of code instances within a defined time period, wherein each of the set of code instances indicates that a code of a set of codes was detected within the noisy assessment record” is equivalently, storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv);
“outputting the inferred type of multiple sclerosis”, is equivalently, Presenting offers, OIP Techs., MPEP 2106.05(d)(II)(iv)
“when the alert criterion is satisfied: generating an alert;” , is equivalently, Determining an estimated outcome, OIP Techs., MPEP 2106.05(d)(II)(v)
“and outputting the alert.”, is equivalently, Presenting offers, OIP Techs., MPEP 2106.05(d)(II)(iv)
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. These additional limitations amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields. To elaborate:
claim 3 and 16’s “wherein inferring that the type of multiple sclerosis corresponds to the subject and the defined time period includes: detecting that the subject was inferred to have had another type of multiple sclerosis during another time period that was before the defined time period; retrieving a type criterion associated with a previous inference of the other type of multiple sclerosis; determining, based on the set of code instances, that the type criterion is not satisfied; in response to determining that the type criterion is not satisfied, evaluating another type criterion using the set of code instances; determining that the other type criterion is satisfied; and determining that the type of multiple sclerosis is associated with the other type criterion.”, is equivalently, Arranging a hierarchy of groups, sorting information, Versata Dev. Group, Inc. v. SAP Am., Inc., MPEP 2106.05(d)(II)(ii)
claim 4 and 17’s “wherein inferring that the type of multiple sclerosis corresponds to the subject and the defined time period includes: detecting that the subject was inferred to have had another type of multiple sclerosis during another time period that was before the defined time period; retrieving a type criterion associated with a previous inference of the other type of multiple sclerosis; determining, based on the set of code instances, that the type criterion is not satisfied; in response to determining that the type criterion is not satisfied, iteratively evaluating each of multiple other type criteria until one of the multiple other type criteria is satisfied; and determining that the type of multiple sclerosis is associated with the one of the multiple other type criteria that is satisfied.”, is equivalently, Arranging a hierarchy of groups, sorting information, Versata Dev. Group, Inc. v. SAP Am., Inc., MPEP 2106.05(d)(II)(ii)
claim 12 “selecting a treatment for the subject based on the inferred type of multiple sclerosis.” is equivalently, Performing clinical tests on individuals, In re Grams, MPEP 2106.05(g)(3)(i)
claim 13 “predicting that the subject is eligible for a clinical study based in part on the inferred type of multiple sclerosis.”, is equivalently, arranging a hierarchy of groups, sorting information, Versata Dev. Group, Inc. v. SAP Am., Inc., MPEP 2106.05(d)(II)(ii)
claim 14 “assigning the subject to a cohort of a clinical study based at least in part on the inferred type of multiple sclerosis”, is equivalently, electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii);
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Piani Meier et al. (WO2020161131) in view of Heywood et al. (US20090125333) and further in view of Francois et al. (US20160110523).
Regarding claim 1, Piani Meier teaches:
A computing system comprising: ([page 12, lines 33-35] “a computer implemented method for determining a state of Multiple Sclerosis (MS) in a MS patient”)
one or more data processors; ([page 5, line 12] “one or more processors”)
and one or more computer-readable storage media containing instructions which, when executed by the one or more data processors, cause the one or more data processors to perform a set of actions comprising ([page 67, line 35- page 68, line 11] “It should be noted that any system, method, and/or other components disclosed herein may be described … as data and/or instructions embodied in various computer-readable media… When received within a computer system via one or more computer-readable media, such data and/or instruction-based expressions of the above described components may be processed by a processing entity (e.g., one or more processors) within the computer system”)
inferring one or more types of multiple sclerosis that corresponds to the subject within the defined time period based on the set of code instances; ([page 5, lines 10-11] “In a first aspect of the present technique a method for determining a state of Multiple Sclerosis (MS) in a MS patient is presented” and [page 5, lines 24-28] “In an embodiment of the invention, each 'item' is a patient data query. Queries may pertain to either relapse and recovery of the patient in the first predetermined period, or symptoms experienced by the patient in the second predetermined period or impacts due to MS experienced by the patient in the third predetermined period.” Where the diagnosis is based on predetermined periods [i.e., a defined time period] for a query [comprising a set of code instances] for a subject)
determining a modulation for the subject based on the temporal dynamic or distribution; ([page 30, lines 3-8] “The score of a given item may be calculated or determined for example, but not limited to, by an averaging of the scores of the selected responses of the sub-items or by an addition of the scores of the selected responses of the sub-items, or by weighted averaging of the scores of the selected responses of the subitems or any other suitable statistical operation.” Comprises a modulation based on the distribution)
determining whether an alert criterion is satisfied based on whether the modulation is above a threshold so as to represent noise or a predicted transition across the one or more types of multiple sclerosis; ([page 41, lines 30-36] “The determination that the MS is still in RRMS state is done by the one or more processors by comparing the total score to a first threshold score for example if the total score is below the first threshold score. The determination that the MS has progressed from RRMS state to SPMS state is done by the one or more processors by comparing the total score to a second threshold score for example if the total score is equal to or above the second threshold score. The threshold scores, i.e. the first and the second threshold scores, are predetermined numerical values.” Where using thresholds to determine whether a score is indicative of a transition across types of multiple sclerosis comprises alert generation logic)
outputting the one or more types of multiple sclerosis ([page 12, lines 19-20] “The system comprises a display configured to output a graphical user interface (GUI) to a user” and [page 14, lines 17 and 18] “the GUI may also include, besides the fields for displaying the patient data queries and the age query, a field for displaying EDSS query” where displaying the Expanded Disability Stratus Scale comprises outputting the inferred type of multiple sclerosis)
Regarding claim 1, Piani Meier does not explicitly discuss, as taught by Heywood:
accessing one or more electronic health records (EHRs) comprising noisy assessment records associated with a subject, ([0066] “Referring to FIG. 3, the invention can provide a database of patient profiles 300”) wherein the subject has been diagnosed with multiple sclerosis ([0018-19] “The patient profile can include a plurality of medical condition parameters… The medical condition parameters are associated with a particular disease or conditions (for example … Multiple Sclerosis”), wherein each noisy assessment record of the noisy assessment records is an electronic file comprising content originating from a device of a care provider that identifies an assessment of the subject, ([0051] “The web-based system can return a set of matching profiles from the database of patient profiles. The patient can view the matching profiles and perform further queries. The query can be performed by the patient's doctor, nurse, or medical assistant on behalf of the patient.”) and wherein the assessment comprises a characteristic of the subject or of a treatment for the subject; ([0052] “The patient can obtain medical outcomes based on entered medical condition parameters. For example, the patient can learn about a treatment for MS by selecting the treatment”)
extracting, from the one or more EHRs, a set of code instances within a defined time period, wherein each of the set of code instances indicates that a code of a set of codes was detected within the noisy assessment record, ([Fig. 3] patient database tables (309) contain multiple code instances for each patient profile such as a unique identifier, defined time periods for treatment or symptoms (324))
determining a temporal dynamic or distribution for the subject based on the set of code instances within the defined time period detected within the noisy assessment data; ([0081] “the query result can include medical outcome predictions 800… As shown on FIG. 8, the patient's answers can be combined to derive a Functional Rating Scale (FRS) score displayed on the vertical axis of the graph 802… The patient's FRS score can be displayed at plurality of score dates, for example, at the time of diagnosis in April of 2006 (804), and at a current date, for example, April 2007 (806). A line can show … future predictions of what the FRS score could be at future dates” and [0082] “the prediction can show statistical variances of the FRS scores)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier with the teachings of Heywood, with a reasonable expectation of success, by integrating Heywood’s Functional Rating System and EHR code extraction system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care by creating timely response to treatment results with disease forecasting estimation that immediately extracts patient’s pertinent health records. Heywood is adaptable to Piani Meier as both inventions utilize generic computer components to access diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Heywood’s teaching that there is a need to integrate disease progression tools across multiple patients so a patient can “better understand and manage a medical condition” [0002] over a lengthy disease progression.
Regarding claim 1, Piani Meier does not explicitly teach, as taught by Francois:
and generating an alert when the alert criterion is determined to be satisfied; and ([0420] In some embodiments an app may issue an alert (which term may be used interchangeably with “notification” or “notice”)… In some embodiments an alert warns a patient of a potentially health-threatening event or situation.” Where the app issuing an alert updating the patient on the active diagnosis module comprises an alert generator to generate an alert when criterion is satisfied)
outputting… the alert when the alert criterion is determined to be satisfied. ([0246] “In some embodiments a subscriber (or other user) may elect to receive an alert (e.g., via email, text message, phone call, voicemail, fax, etc.) when particular information of interest to the subscriber is entered or when particular conditions of interest to the subscriber are met.” Where sending a message to a patient based on a patient’s condition being met comprises outputting a generated alert criterion after the criterion are satisfied)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier- Heywood with the teachings of Francois, with a reasonable expectation of success, by integrating Francois’s alert system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care as they progress through stages of multiple sclerosis with more timely diagnosis and treatment options. Francois is adaptable to Piani Meier as both inventions utilize generic computer components to access electronic health record diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Francois’s teaching that “Patients may have multiple medical records generated at different medical facilities at which they have received care” [0001] which prevents accurate diagnosis of multiple sclerosis disease progression.
Regarding claim 2, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein the set of actions further comprises inferring a subsequent type of the multiple sclerosis corresponding to the subject within another later time period that is subsequent to the defined time period. ([page 8, lines 20-22] “processors determines or calculates or predicts if the MS patient is still in RRMS state or if the MS patient has progressed from the RRMS state to the SPMS state, or if the MS patient is in transition” and [page 5, lines 24-28] “each 'item' is a patient data query. Queries may pertain to either relapse and recovery of the patient in the first predetermined period, or symptoms experienced by the patient in the second predetermined period or impacts due to MS experienced by the patient in the third predetermined period. In an embodiment of the invention, each of the first, the second and the third predetermined periods are established” Where the diagnosis is based on multiple predetermined periods [i.e., a later defined time period] for a query [comprising a set of code instances] for a subject)
Regarding claim 3, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein inferring the one or more type of the multiple sclerosis comprises: ([page 8, lines 20-22] “processors determines or calculates or predicts if the MS patient is still in RRMS state or if the MS patient has progressed from the RRMS state to the SPMS state, or if the MS patient is in transition)
detecting, based on the one or more EHRs, ([page 66, lines 30-31] “The processing system can also include or be coupled to at least one database.”) that the subject was inferred to have had another type of the multiple sclerosis during another time period that was before the defined time period; ([page 20, lines 28-36] “Furthermore, the present technique has been described hereinafter for embodiments in which the first state of the MS is RRMS and the second state of MS is SPMS, however it may be noted that the first state and the second states may be states of MS other than RRMS and SPMS, for example as explained hereinabove, the first state may be in transition from RRMS to SPMS’ state when the second state is SPMS state, or the second state may be in-transition from RRMS to SPMS’ state when the first state is RRMS state” where in-transition from the first stage of MS to the second comprises detecting that the subject has another type of MS during another period before the defined time period)
retrieving a type criterion associated with a previous inference of the other type of multiple sclerosis; ([page 22-22, lines 30-40 and 1-2] “The patient data queries include a plurality of items ... The ‘weights’ of different items are numerical values that represent importance of a given item vis-a-vis importance of the other items in indicating a particular state of the MS, for example a numerical value that reflects the influence of that item in deciding if the MS is in a first state or in a second state, for example wherein the first state is RRMS and the second state is SPMS,” where the weights corresponding to the different states of MS comprise retrieving a type criterion associated with the other type of MS)
determining, based on the set of code instances, that the type criterion is not satisfied; ([page 21, lines 5-7] “FIG. 2 shows a flow chart depicting a method for determining a state of Multiple Sclerosis (MS) in a patient, for example determining progression of MS in the patient from RRMS to SPMS.” And [page 22, lines 12-22] “In other words, when the first state is RRMS and the second state is SPMS, For example one of the numerals 1, 2 and 3 may be assigned to a given item, such as if there are a total of five items (NI, N2, N3, N4, and NS - any 5 items selected from QI to Q20, e.g. one item -NI -from QI to Q5, two items 15 - N2 and N3 - from Q6 to Ql5 and two items from Ql6 - Q20, as shown in Tables 1, 2, and 3)- each of NI and N3 may be assigned a weight of' I', whereas N2 may be assigned a weight of '2' and each of N4 and NS may be assigned a weight of '3' to reflect that each of the items N4 and NS are more important than each of the items NI to N3 in indicating SPMS state, whereas the item N2 is more important than each of NI and N3 in indicating 20 SPMS state, that NI and N3 items are of equal or substantially equal importance in indicating SPMS state and also that the N4 and NS items are of equal or substantially equal importance in indicating SPMS state.”)
in response to determining that the type criterion is not satisfied, evaluating another type criterion using the set of code instances; ([page 23, lines 3-8] “The phrase ‘score’ as used in the present technique may also include a numerical value that represent importance of a given response vis-a-vis importance of the other responses for indicating the effect of that item in determining progression from RRMS into SPMS state, for example a numerical value that reflects the influence of that item in further deciding if the disease has progressed into SPMS from RRMS”)
determining that the other type criterion is satisfied; and ([page 23, lines 8-15] “For example one of the numerals 0, 1, 2, and 3 may be assigned to a given response, such as if there are a total of five responses for a given item (say 1st to 5th response corresponding to a given item)- each of 1st response and 2nd response may be assigned a score of' 0', 3rd response may be assigned a score of' I', 4th response may be assigned a score of' 2' and 5th response may be assigned a score of' 3' to reflect that the order of importance of that item in indicating SPMS progression is - 5th response (most important or most crucial) then 4th response then 3rd response and then each of the 1st and 2nd responses.” Where the numerical indicating the ranking of weighted factors to indicate the type of MS comprises determining whether the other criterion is satisfied)
determining that the one or more types of the multiple sclerosis is associated with the other type criterion. ([page 23, lines 35-39] “In the present technique, the ‘weights’ and ‘scores’ may be determined based on: (a) multiple logistic regression conducted on observational study variables (i.e. the items as referred to in the present disclosure) to identify how strongly each variable contributed to determination of SPMS state,”)
Regarding claim 4, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein inferring the one or more types of the multiple sclerosis comprises: ([page 8, lines 20-22] “processors determines or calculates or predicts if the MS patient is still in RRMS state or if the MS patient has progressed from the RRMS state to the SPMS state, or if the MS patient is in transition)
detecting, based on the one or more EHRs, ([page 66, lines 30-31] “The processing system can also include or be coupled to at least one database.”) that the subject was inferred to have had another type of the multiple sclerosis during another time period that was before the defined time period; ([page 20, lines 28-36] “Furthermore, the present technique has been described hereinafter for embodiments in which the first state of the MS is RRMS and the second state of MS is SPMS, however it may be noted that the first state and the second states may be states of MS other than RRMS and SPMS, for example as explained hereinabove, the first state may be in transition from RRMS to SPMS’ state when the second state is SPMS state, or the second state may be in-transition from RRMS to SPMS’ state when the first state is RRMS state” where in-transition from the first state of MS to the second comprises detecting that the subject has another type of MS during another period before the defined time period)
retrieving a type criterion associated with a previous inference of the other type of multiple sclerosis; ([page 22-22, lines 30-40 and 1-2] “The patient data queries include a plurality of items ... The ‘weights’ of different items are numerical values that represent importance of a given item vis-a-vis importance of the other items in indicating a particular state of the MS, for example a numerical value that reflects the influence of that item in deciding if the MS is in a first state or in a second state, for example wherein the first state is RRMS and the second state is SPMS,” where the weights corresponding to the different states of MS comprise retrieving a type criterion associated with the multiple other types of MS)
determining, based on the set of code instances, that the type criterion is not satisfied; ([page 21, lines 5-7] “FIG. 2 shows a flow chart depicting a method for determining a state of Multiple Sclerosis (MS) in a patient, for example determining progression of MS in the patient from RRMS to SPMS.” And [page 22, lines 12-22] “In other words, when the first state is RRMS and the second state is SPMS, For example one of the numerals 1, 2 and 3 may be assigned to a given item, such as if there are a total of five items (NI, N2, N3, N4, and NS - any 5 items selected from QI to Q20, e.g. one item -NI -from QI to Q5, two items 15 - N2 and N3 - from Q6 to Ql5 and two items from Ql6 - Q20, as shown in Tables 1, 2, and 3)- each of NI and N3 may be assigned a weight of' I', whereas N2 may be assigned a weight of '2' and each of N4 and NS may be assigned a weight of '3' to reflect that each of the items N4 and NS are more important than each of the items NI to N3 in indicating SPMS state, whereas the item N2 is more important than each of NI and N3 in indicating 20 SPMS state, that NI and N3 items are of equal or substantially equal importance in indicating SPMS state and also that the N4 and NS items are of equal or substantially equal importance in indicating SPMS state.” Comprises determining that one type criterion is not satisfied)
in response to determining that the type criterion is not satisfied, iteratively evaluating each of multiple other type criteria until one of the multiple other type criteria is satisfied; and ([page 23, lines 3-8] “The phrase ‘score’ as used in the present technique may also include a numerical value that represent importance of a given response vis-a-vis importance of the other responses for indicating the effect of that item in determining progression from RRMS into SPMS state, for example a numerical value that reflects the influence of that item in further deciding if the disease has progressed into SPMS from RRMS” where determining the score to indicate the progression from RRMS to SPMS comprises evaluating multiple other type criteria until one of them is satisfied.)
determining that the one or more types of multiple sclerosis of the multiple sclerosis is associated with the one of the multiple other type criteria that is satisfied. ([page 23, lines 35-39] “In the present technique, the ‘weights’ and ‘scores’ may be determined based on: (a) multiple logistic regression conducted on observational study variables (i.e. the items as referred to in the present disclosure) to identify how strongly each variable contributed to determination of SPMS state,” see also [page 5, lines ] “classify MS patients into different types of disease patterns, simply put generally MS is classified into 3 main clinical courses (phenotypes): Relapsing remitting MS (RRMS), Secondary progressive MS (SPMS) and Primary progressive MS (PPMS).” Where the different types of disease patterns comprise multiple types of MS)
Regarding claim 5, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein the alert criterion is determined to be satisfied when the modulation indicates that the subject transitioned from a particular type of multiple sclerosis to a different particular type of multiple sclerosis, and wherein the transition is inconsistent with a definition of the different particular type of multiple sclerosis. ([page 22-22, lines 30-40 and 1-2] “The patient data queries include a plurality of items ... The ‘weights’ of different items are numerical values that represent importance of a given item vis-a-vis importance of the other items in indicating a particular state of the MS, for example a numerical value that reflects the influence of that item in deciding if the MS is in a first state or in a second state, for example wherein the first state is RRMS and the second state is SPMS,” where the weights corresponding to the different states of MS comprise a modulation indicating that a transition of a MS state occurred due to an inconsistency of definitions)
Regarding claim 6, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein the alert criterion is determined to be satisfied when the set code instances include a particular code instance representing a particular type of multiple sclerosis and a term representing an observation that is inconsistent with the particular type of the multiple sclerosis. ([page 21, lines 5-7] “FIG. 2 shows a flow chart depicting a method for determining a state of Multiple Sclerosis (MS) in a patient, for example determining progression of MS in the patient from RRMS to SPMS.” and [page 22, lines 12-22] “In other words, when the first state is RRMS and the second state is SPMS, For example one of the numerals 1, 2 and 3 may be assigned to a given item, such as if there are a total of five items (NI, N2, N3, N4, and NS - any 5 items selected from QI to Q20, e.g. one item -NI -from QI to Q5, two items 15 - N2 and N3 - from Q6 to Ql5 and two items from Ql6 - Q20, as shown in Tables 1, 2, and 3)- each of NI and N3 may be assigned a weight of' I', whereas N2 may be assigned a weight of '2' and each of N4 and NS may be assigned a weight of '3' to reflect that each of the items N4 and NS are more important than each of the items NI to N3 in indicating SPMS state, whereas the item N2 is more important than each of NI and N3 in indicating 20 SPMS state, that NI and N3 items are of equal or substantially equal importance in indicating SPMS state and also that the N4 and NS items are of equal or substantially equal importance in indicating SPMS state.” Comprises codes representing a criterion for a particular type of multiple sclerosis and [page 23, lines 35-39] “In the present technique, the 'weights' and 'scores' may be determined based on: (a) multiple logistic regression conducted on observational study variables (i.e. the items as referred to in the present disclosure) to identify how strongly each variable contributed to determination of SPMS state,” where weights that use observational studies variables to determine the state of MS in a patient comprises a term representing a particular type of MS)
Regarding claim 7, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein the one or more types of the multiple sclerosis is one of: relapsing multiple sclerosis, secondary progressive multiple sclerosis, and primary progressive multiple sclerosis. ([page 21, lines 5-7] “FIG. 2 shows a flow chart depicting a method for determining a state of Multiple Sclerosis (MS) in a patient, for example determining progression of MS in the patient from RRMS to SPMS.”)
Regarding claim 8, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein the set of codes includes one or more codes representing a relapse, one or more codes representing progression, and one or more codes representing a type of the multiple sclerosis. ([page 5, lines 24-28] “In an embodiment of the invention, each 'item' is a patient data query. Queries may pertain to either relapse and recovery of the patient in the first predetermined period, or symptoms experienced by the patient in the second predetermined period or impacts due to MS experienced by the patient in the third predetermined period.” Where the query [comprising a set of code instances] comprises information representing a relapse and recovery for a subject)
Regarding claim 9, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein a dissatisfaction of the alert criterion represents predicted disease stability. ([page 23, lines 3-8] “The phrase ‘score’ as used in the present technique may also include a numerical value that represent importance of a given response vis-a-vis importance of the other responses for indicating the effect of that item in determining progression from RRMS into SPMS state, for example a numerical value that reflects the influence of that item in further deciding if the disease has progressed into SPMS from RRMS” where determining the score to indicate the progression from RRMS to SPMS comprises predicting disease stability by indicating a dissatisfaction of disease progression via a score indicating the effect of a criterion in disease progression.)
Regarding claim 10, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 1. Piani Meier also teaches:
wherein extracting the set of code instances within the defined time period includes detecting that, for each code instance in the set of code instances, a time stamp associated with the code instance is within the defined time period. (page 24, lines 12-22] “ In the example of FIG. 3, FIGs. 4A - 4J and FIG. 5 the predetermined period is six months (6 months) previous to and starting from a date when the present technique is being performed i.e. when a user such as a physician or healthcare provider is using the present technique to obtain a determination of whether the MS is in first state or the MS is in second state. It may be noted, that 6 months is used for exemplary purpose only, and the predetermined period may have a different duration … the starting date for calculating the predetermined period may be different from the date when the present technique is being performed, for example a date when last Magnetic resonance imaging (MRI) of the patient was performed or a date when the last EDSS assessment of the patient was performed” where determining the start date of an assessment [comprising detecting a timestamp associated with a code] is within a defined time period)
Regarding claim 11, Piani Meier teaches:
A computer-implemented method comprising: ([page 12, lines 33-35] “a computer implemented method for determining a state of Multiple Sclerosis (MS) in a MS patient”)
inferring one or more types of the multiple sclerosis that correspond to the subject within the defined time period based on the set of code instances; ; ([page 5, lines 10-11] “In a first aspect of the present technique a method for determining a state of Multiple Sclerosis (MS) in a MS patient is presented” and [page 5, lines 24-28] “In an embodiment of the invention, each 'item' is a patient data query. Queries may pertain to either relapse and recovery of the patient in the first predetermined period, or symptoms experienced by the patient in the second predetermined period or impacts due to MS experienced by the patient in the third predetermined period.” Where the diagnosis is based on predetermined periods [i.e., a defined time period] for a query [comprising a set of code instances] for a subject)
determining a modulation for the subject based on the temporal dynamic or the distribution; ([page 30, lines 3-8] “The score of a given item may be calculated or determined for example, but not limited to, by an averaging of the scores of the selected responses of the sub-items or by an addition of the scores of the selected responses of the sub-items, or by weighted averaging of the scores of the selected responses of the subitems or any other suitable statistical operation.” Comprises a modulation based on the distribution)
determining whether an alert criterion is satisfied based on whether the modulation is above a threshold so as to represent noise or a predicted transition across the one or more types of the multiple sclerosis; ([page 41, lines 30-36] “The determination that the MS is still in RRMS state is done by the one or more processors by comparing the total score to a first threshold score for example if the total score is below the first threshold score. The determination that the MS has progressed from RRMS state to SPMS state is done by the one or more processors by comparing the total score to a second threshold score for example if the total score is equal to or above the second threshold score. The threshold scores, i.e. the first and the second threshold scores, are predetermined numerical values.” Where using thresholds to determine whether a score is indicative of a transition across types of multiple sclerosis comprises alert generation logic)
outputting the one or more types of the multiple sclerosis; and ([page 14, lines 17 and 18] “the GUI may also include, besides the fields for displaying the patient data queries and the age query, a field for displaying EDSS query” where displaying the Expanded Disability Stratus Scale comprises outputting the inferred type of multiple sclerosis)
Regarding claim 11, Piani Meier does not explicitly teach, as taught by Heywood:
accessing one or more electronic health records (EHRs) comprising noisy assessment records associated with a subject, ([0066] “Referring to FIG. 3, the invention can provide a database of patient profiles 300”) wherein the subject has been diagnosed with multiple sclerosis ([0018-19] “The patient profile can include a plurality of medical condition parameters… The medical condition parameters are associated with a particular disease or conditions (for example … Multiple Sclerosis”), wherein each noisy assessment record of the noisy assessment records is an electronic file comprising content originating from a device of a care provider that identifies an assessment of the subject, ([0051] “The web-based system can return a set of matching profiles from the database of patient profiles. The patient can view the matching profiles and perform further queries. The query can be performed by the patient's doctor, nurse, or medical assistant on behalf of the patient.”) and wherein the assessment comprises a characteristic of the subject or of a treatment for the subject; ([0052] “The patient can obtain medical outcomes based on entered medical condition parameters. For example, the patient can learn about a treatment for MS by selecting the treatment”)
extracting, from the one or more EHRs, a set of code instances within a defined time period, wherein each of the set of code instances indicates that a code of a set of codes was detected within the noisy assessment data record, ([Fig. 3] patient database tables (309) contain multiple code instances for each patient profile such as a unique identifier, defined time periods for treatment or symptoms (324))
determining a temporal dynamic or distribution for the subject based on the set of code instances within the defined time period; ([0081] “the query result can include medical outcome predictions 800… As shown on FIG. 8, the patient's answers can be combined to derive a Functional Rating Scale (FRS) score displayed on the vertical axis of the graph 802… The patient's FRS score can be displayed at plurality of score dates, for example, at the time of diagnosis in April of 2006 (804), and at a current date, for example, April 2007 (806). A line can show … future predictions of what the FRS score could be at future dates” and [0082] “the prediction can show statistical variances of the FRS scores)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier with the teachings of Heywood, with a reasonable expectation of success, by integrating Heywood’s Functional Rating System and EHR code extraction system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care by creating timely response to treatment results with disease forecasting estimation that immediately extracts patient’s pertinent health records. Heywood is adaptable to Piani Meier as both inventions utilize generic computer components to access diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Heywood’s teaching that there is a need to integrate disease progression tools across multiple patients so a patient can “better understand and manage a medical condition” [0002] over a lengthy disease progression.
Regarding claim 11, Piani Meier does not explicitly teach, as taught by Francois:
when the alert criterion is satisfied: generating an alert; and outputting the alert. ([0246] “In some embodiments a subscriber (or other user) may elect to receive an alert (e.g., via email, text message, phone call, voicemail, fax, etc.) when particular information of interest to the subscriber is entered or when particular conditions of interest to the subscriber are met.” Where sending a message to a patient based on a patient’s condition being met comprises outputting a generated alert criterion after the criterion are satisfied)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier- Heywood with the teachings of Francois, with a reasonable expectation of success, by integrating Francois’s alert system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care as they progress through stages of multiple sclerosis with more timely diagnosis and treatment options. Francois is adaptable to Piani Meier as both inventions utilize generic computer components to access electronic health record diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Francois’s teaching that “Patients may have multiple medical records generated at different medical facilities at which they have received care” [0001] which prevents accurate diagnosis of multiple sclerosis disease progression.
Regarding claim 12, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Piani Meier also teaches:
further comprising: selecting a treatment for the subject based on the one or more types of the multiple sclerosis. ([page 49, lines 35-37] “The invention further concerns a method for treating multiple sclerosis (MS) in a patient in need thereof, wherein in the second step an MS therapeutic is administered to the patient based on the state so determined.” Where administering therapeutic to a patient comprises selecting a treatment for the subject)
Regarding claim 13, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Francois also teaches:
further comprising: predicting that the subject is eligible for a clinical study based in part on the one or more types of the multiple sclerosis. ([0006] “data from the database is accessed, retrieved, analyzed, or provided to a subscriber in response to the request. In some embodiments an EMR in the database contains one or more ADMs adapted for identifying or enrolling subjects in a clinical trial and/or for gathering data pertaining to a clinical trial.”; see also [0029] “the method comprises entering a tentative diagnosis of a disease for a patient, entering sufficient data to establish a confirmed diagnosis of a disease for the patient, and entering sufficient data to determine that the patient is eligible or potentially eligible for a trial of an experimental therapy intended for patients having the disease.” Where the active Diagnostic Modules identifies [i.e., predict that a subject is eligible] for a clinical trial based on a specific disease)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier- Heywood with the teachings of Francois, with a reasonable expectation of success, by integrating Francois’s clinical trial identification system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care as they progress through stages of multiple sclerosis with more accurate treatment options. Francois is adaptable to Piani Meier as both inventions utilize generic computer components to access electronic health record diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Francois’s teaching that “Patients may have multiple medical records generated at different medical facilities at which they have received care” [0001] which prevents accurate diagnosis of multiple sclerosis disease progression.
Regarding claim 14, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Francois also teaches:
further comprising: assigning the subject to a cohort of a clinical study based at least in part on the one or more types of the multiple sclerosis. ([0029] “In some embodiments the method further comprises enrolling or arranging for enrollment of the patient in a clinical trial or managed access program for which the patient is eligible.”; see also ([0306] “For example… neurologists may receive alerts regarding white label drugs for multiple sclerosis” where the system enrolling a patient into a clinical trial comprises an assigning a subject to a clinical trial based in part on the type of multiple sclerosis)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier- Heywood with the teachings of Francois, with a reasonable expectation of success, by integrating Francois’s clinical trial identification system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care as they progress through stages of multiple sclerosis with more accurate treatment options. Francois is adaptable to Piani Meier as both inventions utilize generic computer components to access electronic health record diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Francois’s teaching that “Patients may have multiple medical records generated at different medical facilities at which they have received care” [0001] which prevents accurate diagnosis of multiple sclerosis disease progression.
Regarding claim 15, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Piani Meier also teaches:
further comprising, in response to inferring that one or more types of the multiple sclerosis: inferring that a subsequent type of multiple sclerosis corresponding to the subject and within another later time period that is subsequent to the defined time period. ([page 8, lines 20-22] “processors determines or calculates or predicts if the MS patient is still in RRMS state or if the MS patient has progressed from the RRMS state to the SPMS state, or if the MS patient is in transition and [page 5, lines 24-28] “In an embodiment of the invention, each 'item' is a patient data query. Queries may pertain to either relapse and recovery of the patient in the first predetermined period, or symptoms experienced by the patient in the second predetermined period or impacts due to MS experienced by the patient in the third predetermined period. In an embodiment of the invention, each of the first, the second and the third predetermined periods are established” Where the diagnosis is based on multiple predetermined periods [i.e., a later defined time period] for a query [comprising a set of code instances] for a subject)
Regarding claim 16, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Piani Meier also teaches:
wherein inferring that the one or more types of multiple sclerosis comprises: ([page 8, lines 20-22] “processors determines or calculates or predicts if the MS patient is still in RRMS state or if the MS patient has progressed from the RRMS state to the SPMS state, or if the MS patient is in transition)
detecting, based on the one or more EHRs, ([page 66, lines 30-31] “The processing system can also include or be coupled to at least one database.”) that the subject was inferred to have had another type of the multiple sclerosis during another time period that was before the defined time period; ([page 20, lines 28-36] “Furthermore, the present technique has been described hereinafter for embodiments in which the first state of the MS is RRMS and the second state of MS is SPMS, however it may be noted that the first state and the second states may be states of MS other than RRMS and SPMS, for example as explained hereinabove, the first state may be in transition from RRMS to SPMS’ state when the second state is SPMS state, or the second state may be in-transition from RRMS to SPMS’ state when the first state is RRMS state” where in-transition from the first stage of MS to the second comprises detecting that the subject has another type of MS during another period before the defined time period)
retrieving a type of the criterion associated with a previous inference of the other type of multiple sclerosis; ([page 22-22, lines 30-40 and 1-2] “The patient data queries include a plurality of items ... The ‘weights’ of different items are numerical values that represent importance of a given item vis-a-vis importance of the other items in indicating a particular state of the MS, for example a numerical value that reflects the influence of that item in deciding if the MS is in a first state or in a second state, for example wherein the first state is RRMS and the second state is SPMS,” where the weights corresponding to the different states of MS comprise retrieving a type criterion associated with the other type of MS)
determining, based on the set of code instances, that the type criterion is not satisfied; ([page 21, lines 5-7] “FIG. 2 shows a flow chart depicting a method for determining a state of Multiple Sclerosis (MS) in a patient, for example determining progression of MS in the patient from RRMS to SPMS.” And [page 22, lines 12-22] “In other words, when the first state is RRMS and the second state is SPMS, For example one of the numerals 1, 2 and 3 may be assigned to a given item, such as if there are a total of five items (NI, N2, N3, N4, and NS - any 5 items selected from QI to Q20, e.g. one item -NI -from QI to Q5, two items 15 - N2 and N3 - from Q6 to Ql5 and two items from Ql6 - Q20, as shown in Tables 1, 2, and 3)- each of NI and N3 may be assigned a weight of' I', whereas N2 may be assigned a weight of '2' and each of N4 and NS may be assigned a weight of '3' to reflect that each of the items N4 and NS are more important than each of the items NI to N3 in indicating SPMS state, whereas the item N2 is more important than each of NI and N3 in indicating 20 SPMS state, that NI and N3 items are of equal or substantially equal importance in indicating SPMS state and also that the N4 and NS items are of equal or substantially equal importance in indicating SPMS state.”)
in response to determining that the type criterion is not satisfied, evaluating another type criterion using the set of code instances; ([page 23, lines 3-8] “The phrase ‘score’ as used in the present technique may also include a numerical value that represent importance of a given response vis-a-vis importance of the other responses for indicating the effect of that item in determining progression from RRMS into SPMS state, for example a numerical value that reflects the influence of that item in further deciding if the disease has progressed into SPMS from RRMS”)
determining that the other type criterion is satisfied; ([page 23, lines 8-15] “For example one of the numerals 0, 1, 2, and 3 may be assigned to a given response, such as if there are a total of five responses for a given item (say 1st to 5th response corresponding to a given item)- each of 1st response and 2nd response may be assigned a score of' 0', 3rd response may be assigned a score of' I', 4th response may be assigned a score of' 2' and 5th response may be assigned a score of' 3' to reflect that the order of importance of that item in indicating SPMS progression is - 5th response (most important or most crucial) then 4th response then 3rd response and then each of the 1st and 2nd responses.” Where the numerical indicating the ranking of weighted factors to indicate the type of MS comprises determining whether the other criterion is satisfied)
and determining that the one or more types of the multiple sclerosis is associated with the other type criterion. ([page 23, lines 35-39] “In the present technique, the ‘weights’ and ‘scores’ may be determined based on: (a) multiple logistic regression conducted on observational study variables (i.e. the items as referred to in the present disclosure) to identify how strongly each variable contributed to determination of SPMS state,”)
Regarding claim 17, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Piani Meier also teaches:
wherein inferring the one or more types of multiple sclerosis comprises: ([page 5, lines 10-11] “In a first aspect of the present technique a method for determining a state of Multiple Sclerosis (MS) in a MS patient is presented” and [page 5, lines 24-28] “In an embodiment of the invention, each 'item' is a patient data query. Queries may pertain to either relapse and recovery of the patient in the first predetermined period, or symptoms experienced by the patient in the second predetermined period or impacts due to MS experienced by the patient in the third predetermined period.” Where the diagnosis is based on predetermined periods [i.e., a defined time period] for a query [comprising a set of code instances] for a subject)
detecting, based on the one or more EHRs, ([page 66, lines 30-31] “The processing system can also include or be coupled to at least one database.”) that the subject was inferred to have had another type of multiple sclerosis during another time period that was before the defined time period; ([page 20, lines 28-36] “Furthermore, the present technique has been described hereinafter for embodiments in which the first state of the MS is RRMS and the second state of MS is SPMS, however it may be noted that the first state and the second states may be states of MS other than RRMS and SPMS, for example as explained hereinabove, the first state may be in transition from RRMS to SPMS’ state when the second state is SPMS state, or the second state may be in-transition from RRMS to SPMS’ state when the first state is RRMS state” where in-transition from the first state of MS to the second comprises detecting that the subject has another type of MS during another period before the defined time period)
retrieving a type criterion associated with a previous inference of the other type of the multiple sclerosis; ([page 22-22, lines 30-40 and 1-2] “The patient data queries include a plurality of items ... The ‘weights’ of different items are numerical values that represent importance of a given item vis-a-vis importance of the other items in indicating a particular state of the MS, for example a numerical value that reflects the influence of that item in deciding if the MS is in a first state or in a second state, for example wherein the first state is RRMS and the second state is SPMS,” where the weights corresponding to the different states of MS comprise retrieving a type criterion associated with the multiple other types of MS)
determining, based on the set of code instances, that the type criterion is not satisfied; ([page 21, lines 5-7] “FIG. 2 shows a flow chart depicting a method for determining a state of Multiple Sclerosis (MS) in a patient, for example determining progression of MS in the patient from RRMS to SPMS.” And [page 22, lines 12-22] “In other words, when the first state is RRMS and the second state is SPMS, For example one of the numerals 1, 2 and 3 may be assigned to a given item, such as if there are a total of five items (NI, N2, N3, N4, and NS - any 5 items selected from QI to Q20, e.g. one item -NI -from QI to Q5, two items 15 - N2 and N3 - from Q6 to Ql5 and two items from Ql6 - Q20, as shown in Tables 1, 2, and 3)- each of NI and N3 may be assigned a weight of' I', whereas N2 may be assigned a weight of '2' and each of N4 and NS may be assigned a weight of '3' to reflect that each of the items N4 and NS are more important than each of the items NI to N3 in indicating SPMS state, whereas the item N2 is more important than each of NI and N3 in indicating 20 SPMS state, that NI and N3 items are of equal or substantially equal importance in indicating SPMS state and also that the N4 and NS items are of equal or substantially equal importance in indicating SPMS state.” Comprises determining that one type criterion is not satisfied)
in response to determining that the type criterion is not satisfied, iteratively evaluating each of multiple other type criteria until one of the multiple other type criteria is satisfied; ([page 23, lines 3-8] “The phrase ‘score’ as used in the present technique may also include a numerical value that represent importance of a given response vis-a-vis importance of the other responses for indicating the effect of that item in determining progression from RRMS into SPMS state, for example a numerical value that reflects the influence of that item in further deciding if the disease has progressed into SPMS from RRMS” where determining the score to indicate the progression from RRMS to SPMS comprises evaluating multiple other type criteria until one of them is satisfied.)
and determining that the one or more type of the multiple sclerosis is associated with the one of the multiple other type criteria that is satisfied. ([page 23, lines 35-39] “In the present technique, the ‘weights’ and ‘scores’ may be determined based on: (a) multiple logistic regression conducted on observational study variables (i.e. the items as referred to in the present disclosure) to identify how strongly each variable contributed to determination of SPMS state,” see also [page 5, lines ] “classify MS patients into different types of disease patterns, simply put generally MS is classified into 3 main clinical courses (phenotypes): Relapsing remitting MS (RRMS), Secondary progressive MS (SPMS) and Primary progressive MS (PPMS).” Where the different types of disease patterns comprise multiple types of MS)
Regarding claim 18, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Piani Meier also teaches:
wherein the alert criterion is determined to be satisfied when the modulation indicates that the subject transitioned from a particular type of the multiple sclerosis to a different particular type of multiple sclerosis, and wherein the transition is inconsistent with a definition of the different particular type of multiple sclerosis. ([page 22-22, lines 30-40 and 1-2] “The patient data queries include a plurality of items ... The ‘weights’ of different items are numerical values that represent importance of a given item vis-a-vis importance of the other items in indicating a particular state of the MS, for example a numerical value that reflects the influence of that item in deciding if the MS is in a first state or in a second state, for example wherein the first state is RRMS and the second state is SPMS,” where the weights corresponding to the different states of MS comprise a modulation indicating that a transition of a MS state occurred due to an inconsistency of definitions)
Regarding claim 19, Piani Meier- Heywood- Francois as a combination teaches all of the limitations of claim 11. Piani Meier also teaches:
wherein the alert criterion is determined to be satisfied when the set code instances include a particular code instance representing a particular type of the multiple sclerosis and a term representing an observation that is inconsistent with the particular type of multiple sclerosis. ([page 21, lines 5-7] “FIG. 2 shows a flow chart depicting a method for determining a state of Multiple Sclerosis (MS) in a patient, for example determining progression of MS in the patient from RRMS to SPMS.” and [page 22, lines 12-22] “In other words, when the first state is RRMS and the second state is SPMS, For example one of the numerals 1, 2 and 3 may be assigned to a given item, such as if there are a total of five items (NI, N2, N3, N4, and NS - any 5 items selected from QI to Q20, e.g. one item -NI -from QI to Q5, two items 15 - N2 and N3 - from Q6 to Ql5 and two items from Ql6 - Q20, as shown in Tables 1, 2, and 3)- each of NI and N3 may be assigned a weight of' I', whereas N2 may be assigned a weight of '2' and each of N4 and NS may be assigned a weight of '3' to reflect that each of the items N4 and NS are more important than each of the items NI to N3 in indicating SPMS state, whereas the item N2 is more important than each of NI and N3 in indicating 20 SPMS state, that NI and N3 items are of equal or substantially equal importance in indicating SPMS state and also that the N4 and NS items are of equal or substantially equal importance in indicating SPMS state.” Comprises codes representing a criterion for a particular type of multiple sclerosis and [page 23, lines 35-39] “In the present technique, the 'weights' and 'scores' may be determined based on: (a) multiple logistic regression conducted on observational study variables (i.e. the items as referred to in the present disclosure) to identify how strongly each variable contributed to determination of SPMS state,” where weights that use observational studies variables to determine the state of MS in a patient comprises a term representing a particular type of MS)
Regarding claim 20, Piani Meier teaches:
A computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform a set of actions including: ([page 65, lines 1-4] “The components of any system that include the technique for determining a state of Multiple Sclerosis in a patient can be located together or in separate locations. Communication paths couple the components and include any medium for communicating or transferring files among the components… Furthermore, the communication paths include removable fixed mediums like floppy 10 disks, hard disk drives,”)
inferring one or more types of multiple sclerosis that correspond to the subject within the defined time period based on the set of code instances; ([page 5, lines 10-11] “In a first aspect of the present technique a method for determining a state of Multiple Sclerosis (MS) in a MS patient is presented” and [page 5, lines 24-28] “In an embodiment of the invention, each 'item' is a patient data query. Queries may pertain to either relapse and recovery of the patient in the first predetermined period, or symptoms experienced by the patient in the second predetermined period or impacts due to MS experienced by the patient in the third predetermined period.” Where the diagnosis is based on predetermined periods [i.e., a defined time period] for a query [comprising a set of code instances] for a subject)
determining a temporal dynamic or distribution for the subject based on the set of code instances within the defined time period; ([page 6-7, lines 32-39 and 4-9] “the responses to the patient data queries are inputted by … a user such as physician for example by selecting one or more of the displayed responses for a given item, for e.g. by selecting only one response from of the displayed responses for a given item… Alternatively, if a plurality of responses are selected or inputted for a given item, then the item score for that item is determined or calculated based on the weight of the item and the scores of the selected responses for that item, for example, but not limited to, by using an average of the scores of the selected responses or for example by using the highest score from the scores of the selected responses.” Where using the average of scores of inputted data queries from a physician regarding the treatment of a patient for multiple sclerosis comprises determining a distribution based on the code instances detected within the noisy data)
determining a modulation for the subject based on the temporal dynamic or the distribution; ([page 30, lines 3-8] “The score of a given item may be calculated or determined for example, but not limited to, by an averaging of the scores of the selected responses of the sub-items or by an addition of the scores of the selected responses of the sub-items, or by weighted averaging of the scores of the selected responses of the subitems or any other suitable statistical operation.” Comprises a modulation based on the distribution)
determining whether an alert criterion is satisfied based on whether the modulation is above a threshold so as to represent noise or a predicted transition across the one or more types of the multiple sclerosis; ([page 41, lines 30-36] “The determination that the MS is still in RRMS state is done by the one or more processors by comparing the total score to a first threshold score for example if the total score is below the first threshold score. The determination that the MS has progressed from RRMS state to SPMS state is done by the one or more processors by comparing the total score to a second threshold score for example if the total score is equal to or above the second threshold score. The threshold scores, i.e. the first and the second threshold scores, are predetermined numerical values.” Where using thresholds to determine whether a score is indicative of a transition across types of multiple sclerosis comprises alert generation logic)
outputting the one or more types of multiple sclerosis; and ([page 14, lines 17 and 18] “the GUI may also include, besides the fields for displaying the patient data queries and the age query, a field for displaying EDSS query” where displaying the Expanded Disability Stratus Scale comprises outputting the inferred type of multiple sclerosis)
Regarding claim 20, Piani Meier does not explicitly discuss, as taught by Heywood:
accessing one or more electronic health records (EHRs) comprising noisy assessment records associated with a subject, ([0066] “Referring to FIG. 3, the invention can provide a database of patient profiles 300”) wherein the subject has been diagnosed with multiple sclerosis ([0018-19] “The patient profile can include a plurality of medical condition parameters… The medical condition parameters are associated with a particular disease or conditions (for example … Multiple Sclerosis”), wherein each noisy assessment record of the noisy assessment records is an electronic file comprising content originating from a device of a care provider that identifies an assessment of the subject, ([0051] “The web-based system can return a set of matching profiles from the database of patient profiles. The patient can view the matching profiles and perform further queries. The query can be performed by the patient's doctor, nurse, or medical assistant on behalf of the patient.”) and wherein the assessment comprises a characteristic of the subject or of a treatment for the subject; ([0052] “The patient can obtain medical outcomes based on entered medical condition parameters. For example, the patient can learn about a treatment for MS by selecting the treatment”)
extracting, from the one or more EHRs, a set of code instances within a defined time period, wherein each of the set of code instances indicates that a code of a set of codes was detected within the noisy assessment record, ([Fig. 3] patient database tables (309) contain multiple code instances for each patient profile such as a unique identifier, defined time periods for treatment or symptoms (324))
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier with the teachings of Heywood, with a reasonable expectation of success, by integrating Heywood’s Functional Rating System and EHR code extraction system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care by creating timely response to treatment results with disease forecasting estimation that immediately extracts patient’s pertinent health records. Heywood is adaptable to Piani Meier as both inventions utilize generic computer components to access diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Heywood’s teaching that there is a need to integrate disease progression tools across multiple patients so a patient can “better understand and manage a medical condition” [0002] over a lengthy disease progression.
Regarding claim 20, Piani Meier does not explicitly teach, as taught by Francois:
when the alert criterion is satisfied: generating an alert; and outputting the alert. ([0246] “In some embodiments a subscriber (or other user) may elect to receive an alert (e.g., via email, text message, phone call, voicemail, fax, etc.) when particular information of interest to the subscriber is entered or when particular conditions of interest to the subscriber are met.” Where sending a message to a patient based on a patient’s condition being met comprises outputting a generated alert criterion after the criterion are satisfied)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piani Meier- Heywood with the teachings of Francois, with a reasonable expectation of success, by integrating Francois’s alert system to Piani Meier’s MS progression detection tool. This would have improved a patient’s quality of care as they progress through stages of multiple sclerosis with more timely diagnosis and treatment options. Francois is adaptable to Piani Meier as both inventions utilize generic computer components to access electronic health record diagnostic tools to determine a patient’s neurological disease state. Piani Meier would have addressed Francois’s teaching that “Patients may have multiple medical records generated at different medical facilities at which they have received care” [0001] which prevents accurate diagnosis of multiple sclerosis disease progression.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action and below.
Oleynik et al. (US20150161331) discloses a system for syndicating data across many medical record systems to categorize patient treatments, outcomes, and forecast disease progression.
Katsuda et al. (US 20170372443) analyzes patient databased while categorizing changes in clinical information over time.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.A.S/Examiner, Art Unit 3792
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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