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 .
Claims 1-20 are pending. Claims 1-20 are rejected herein. The claims received 02 September 2025 amended claims 1,6,8,13,15,19.
Priority
This application claims priority to applications PCT/US 22/28531 and provisional application #63/191,734. The effective priority date used in this office action was 21 May 2021.
Distinguishing Subject Matter
The prior art fails to teach the following from claim 7:
and sending, to an external computing device, the first record associated with the one or more programmatic diagnostic actions, the second record associated with the one or more historical diagnostic actions, and the error rate.
The prior art fails to teach the following from claim 14:
and send, to an external computing device, the first record associated with the one or more programmatic diagnostic actions, the second record associated with the one or more historical diagnostic actions, and the error rate.
The prior art fails to teach the following from claim 20:
and send, to an external computing device, the first record associated with the one or more programmatic diagnostic actions, the second record associated with the one or more historical diagnostic actions, and the error rate.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
decision specification controller
programmatic decision controller
conclusion accuracy controller
The Specification at para. [0026] teaches the one or more logic modules will comprise a decision specification controller, a programmatic decision controller, and a conclusion accuracy module. The Specification at para. [0092] teaches the system memory typically contains data, such as network data, and/or program modules, accessible to and/or are presently operated on by the processor. The drawings contain flow charts which to represent the algorithm and were described in the Specification in written form. Sufficient structure was disclosed in the specification and drawings.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1,8 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method, a system, and an apparatus, which are within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A1
The limitations of receiving […] patient data; determining […] based on the patient data, a care decision logic, wherein determining the care decision logic comprises processing decision specification including decision inputs and decision conclusions received […] and writing the processed decision specification […]; executing […] based on the patient data, the care decision logic to determine a care conclusion, wherein executing the care decision logic comprises retrieving decision framework parameters from the decision parameter and logic storage, generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters; determining, based on executing the care decision logic and the care conclusion, one or more programmatic treatments; receiving, […] a treatment history comprising one or more historical treatments; and determining that the error rate satisfies a statistical significant threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components.
That is, other than reciting a computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface, a decision specification controller, computing device, conclusion accuracy controller, an apparatus comprising one or more processors and memory and a display device the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the listed additional elements, this claim encompasses determining a care conclusion based on this historical data in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2: Practical Application
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of a computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface, a decision specification controller, computing device, conclusion accuracy controller, an apparatus comprising one or more processors and memory and a display device that implements the identified abstract idea. The computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface, a decision specification controller, computing device, conclusion accuracy controller, an apparatus comprising one or more processors and memory and a display device are not described by the applicant and are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Significantly More
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a server to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Dependent Claims and Dependent Additional Elements
Claims 2-5, 8-10, and 12-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 merely describe(s) the specific kind of patient data. Claim(s) 3 merely describe(s) a code associated with an identifier. Claim 4 merely describes determining the care decision logic comprises: receiving a user input; and determining, based on the user input, the decision logic. Claim 5 merely describes determining, based on the one or more inputs, metadata associated with the input; and selecting, based on the metadata, and from a database, the decision logic. Claim 6 merely describes determining the error rate satisfies an error rate threshold; and outputting, based in the error rate satisfying the error rate threshold, a message. Claim 7 merely describes storing programmatic diagnostic actions and historical diagnostic actions, storing the error rate, and sending the first record associated with the one or more diagnostic actions, the second record associated with the one or more historical diagnostic actions, and the error rate. Claim 9 merely describes the type of patient data. Claim 10 merely describes the care decision logic is associated with an identifier and wherein the identifier is associated with a condition. Claim 11 merely describes receiving a user input and determining based on the user input the care decision logic. Claim 12 merely describes determining, based on the one or more inputs, metadata associated with the input; and selecting based on a variety of factor the decision logic. Claim 13 merely describes determining the error rate satisfies an error rate threshold; and output, based on the error rate satisfying the error rate threshold, a message. Claim 14 merely describes storing various records, the error rate and sending the first record associated with the one or more diagnostic actions and the error rate. Claim 16 merely describes patient data comprises at least one of: a survey or an electronic health record. Claim 17 merely describes the care decision logic is associated with an identifier and wherein the identifier is associated with a condition. Claim 18 merely describes receiving a user input and determining based on the user input the care decision logic. Claim 19 merely describes determining the error rate satisfies an statistical significance threshold; and output, based on the error rate satisfying the statistical significance threshold, a message. Claim 20 merely describes storing various records and an error rate and sending a specific record and the error rate.
The dependent claims also include the additional element of “electronic health record” and “ICD code” which generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
The dependent claims also include a database, an external computing device and a computing device. These additional elements were analyzed as per the computer part(s) in the independent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4,6,8-11,13,15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 11183302 B1 (hereafter McNair) in view of US 2007/0112782 A1 (Lobach) in view of US 2014/0156297 A1 (hereafter Schaefer) in view of TW I819049 B (hereafter Tailiang).
Regarding Claim 1
McNair teaches:
A method comprising: receiving, by a computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface, patient data; [McNair teaches at col. 10 line 45-line 50 system comprises one or more computing devices, such as a server, desktop computer, laptop, or tablet, cloud-computing device or distributed computing architecture, a portable computing device such as a laptop, tablet, ultra-mobile P.C., or a mobile phone. The mobile phone in interpreted to teach the input and conclusion interface, surveillance interface and framework specification interface. McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. Collectively, this teaches receiving, by a computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface, patient data.]
determining, by a decision specification controller, based on the patient data, a care decision logic, [McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4530 determining a first set of clinical concepts associated with the first patient. This teaches determining, based on the patient data, a care decision logic. ]
[…]
executing, by a programmatic decision controller, based on the patient data, the care decision logic to determine a care conclusion, [McNair teaches at col. 67 line 61 through col. 68 line 14 that in one aspect of the embodiments described herein, there is provided a system, method, or computer-readable media for providing clinical decision support, comprising: receiving a first set of clinical information associated with a patient from a data store; based on the first set of clinical information, determining a likelihood of a clinical decision support event being associated with the patient; accessing an assessment associated with the clinical decision support event, the assessment including a set of patient related questions; determining from the set of patient related questions; determining from the set of questions a portion of the questions to include in a questionnaire, based on a treatment session context and the first set of clinical information; generating a user interface for presenting the questionnaire; presenting the user interface to a user and receiving a set of answers, via one or more clinical information elements of the user interface, in response to the portion of questions in the questionnaire. Determining a likelihood of a clinical decision support event being associated with the patient is interpreted as executing, based on the patient data, the care decision logic to determine a care conclusion.]
[…]
receiving, by the computing device, a treatment history comprising one or more historical treatments; [McNair teaches at col. 67 line 61 through col. 68 line 14 that in one aspect of the embodiments described herein, there is provided a system, method, or computer-readable media for providing clinical decision support, comprising: receiving a first set of clinical information associated with a patient from a data store; based on the first set of clinical information, determining a likelihood of a clinical decision support event being associated with the patient; accessing an assessment associated with the clinical decision support event, the assessment including a set of patient related questions; determining from the set of patient related questions; determining from the set of questions a portion of the questions to include in a questionnaire, based on a treatment session context and the first set of clinical information; generating a user interface for presenting the questionnaire; presenting the user interface to a user and receiving a set of answers, via one or more clinical information elements of the user interface, in response to the portion of questions in the questionnaire. The answers received via the questionnaire are receiving a treatment history comprising one or more historical treatments.]
McNair may not explicitly teach:
wherein determining the care decision logic comprises processing decision specification including decision inputs and decision conclusions received via the framework specification interface
and writing the processed decision specification to a decision parameter and logic storage;
wherein executing the care decision logic comprises retrieving decision framework parameters from the decision parameter and logic storage,
generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters, determining based on executing the care decision logic and care conclusion, one or more programmatic treatments;
and determining, by a conclusion accuracy controller, based on the treatment history, an error rate, wherein the error rate comprises a difference between the one or more programmatic treatments and the one or more historical treatments;
and determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way.
Lobach teaches:
wherein determining the care decision logic comprises processing decision specification including decision inputs and decision conclusions received via the framework specification interface [Lobach teaches at para. [0072] each module includes a specification of the data requirements for assessing a patient, the patient-specific conclusions that will be returned by the module, and the logic that will be utilized to generate the conclusions using the specified patient data. Lobach further teaches at para. [0073] with Sebastian configured as a Web service, service will be accessed by sending XML requests over HTTP or HTTPs (HTTP over secure socket layer). Lobach teaches at para. [0073] the system will be configured and operated to provide a patient evaluation service as a core service, in which patient data elements are received as the input and machine-interpretable decision support results are returned as the output. Lobach teaches at para. [0082] once the EKMs are encoded, the decision logic will be processed and delivered by a software service that utilizes a standards-based input/output interface to efficiently integrate machine-executable decision logic into various medical software applications.]
and writing the processed decision specification to a decision parameter and logic storage; [Lobach teaches at para. [0072] medical knowledge in the clinical decision support system is captured in XML documents known as Executable Knowledge Modules (EKMs), which are also sometimes therein referred to as Patient Safety Modules. Lobach teaches at para. [0072] each module includes a specification of the data requirements for assessing a patient, the patient-specific conclusions that will be returned by the module, and the logic that will be utilized to generate the conclusions using the specified patient data. Collectively, this teaches and writing the processed decision specification to a decision parameter and logic storage.]
wherein executing the care decision logic comprises retrieving decision framework parameters from the decision parameter and logic storage, [Lobach teaches at para. [0120] the framework will be adapted so that knowledge modules will return various type of machine interpretable result parameters following patient evaluation. Lobach at para. [0126] teaches the use of a standard data storage standard such as XML allows the executable knowledge modules to be edited using powerful standards-based tools. This teaches wherein executing the care decision logic comprises retrieving decision framework parameters from the decision parameter and logic storage.]
generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters, determining based on executing the care decision logic and care conclusion, one or more programmatic treatments; [Lobach teaches at claim 31 the system of claim 3, wherein said patient evaluation service returns machine-interpretable results that comprise at least one of the following: a unique result code, a patient-specific assessment message, a patient-specific recommendation message, and zero or more result parameters. This teaches generating a decision instance with a unique identifier (the unique result code), determining based on executing the care decision logic and care conclusion, one or more programmatic treatments (the patient specific recommendation message) and using the decision framework parameters (zero or more result parameters).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the clinical decision support system using phenotypic features of McNair to the clinical decision support system of Lobach with the motivation of permitting re-use of executable medical knowledge across diverse applications and care settings, easy authoring of knowledge modules, and use of the system framework to implement decision support applications having significant clinical utility (Lobach at the Abstract).
McNair/Lobach may not explicitly teach:
[…]
and determining, by a conclusion accuracy controller, based on the treatment history, an error rate, wherein the error rate comprises a difference between the one or more programmatic treatments and the one or more historical treatments;
and determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way.
Schaefer teaches the following:
and determining, by a conclusion accuracy controller, based on the treatment history, an error rate, wherein the error rate comprises a difference between the one or more programmatic treatments and the one or more historical treatments; [Schaefer teaches at Figure 3 Item 304 receiving/updating patient medical information with portable electronic device and at item 306 administering pre-treatment medication. Schaefer teaches at Figure 3 Item 308 assessing condition of the patient before treatment. This teaches assessing a treatment administered by a program/computer. Schaefer teaches at Figure 3 receiving at portable electronic device instructions from a doctor, item 324 implementing doctor instructions and at Item 326 assessing condition of patient after implementing doctor instructions. This teaches assessing a treatment administered by a doctor. Schaefer teaches at para. [0014] the computer program will further comprise a code segment for comparing the post-treatment patient data to the pre-treatment patient data and/or the treatment patient data and for identifying changes in the condition of the patient based on the comparison. Schaefer teaches at para. [0058] the computer program will further comprise a code segment for determining if the changes in the condition of the patient are greater than a threshold amount, and if they are, transmitting data representative of the changes to the remote computer. Determining if the changes in the condition of the patient are greater than a threshold amount teaches the difference between the one or more programmatic treatments and the one or more historical treatments.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the clinical decision support system using phenotypic features of McNair to the clinical decision support system of Lobach to the computer program, method, and system for pharmacist-assisted treatment of patients of Schaefer with the motivation of addressing the lack of awareness and treatment of CIDP, which is also due to limitations of clinical trials. (Schaefer at para. [0004]).
McNair/Lobach/Schaefer may not explicitly teach:
and determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way.
Schaefer teaches the following noted feature:
and determining […] the care decision logic performs equivalently to or better than human medical practitioners in a […] significant way. [Schaefer teaches at Figure 3 Item 304 receiving/updating patient medical information with portable electronic device and at item 306 administering pre-treatment medication. Schaefer teaches at Figure 3 Item 308 assessing condition of the patient before treatment. This teaches assessing a treatment administered by a program/computer. Schaefer teaches at Figure 3 receiving at portable electronic device instructions from a doctor, item 324 implementing doctor instructions and at Item 326 assessing condition of patient after implementing doctor instructions. This teaches assessing a treatment administered by a doctor. Schaefer teaches at para. [0014] the computer program will further comprise a code segment for comparing the post-treatment patient data to the pre-treatment patient data and/or the treatment patient data and for identifying changes in the condition of the patient based on the comparison. Collectively, this teaches indicating the care decision logic performs equivalently to or better than human medical practitioners in a […] significant way.]
Tailiang teaches the following noted feature:
that the error rate satisfies a statistical significance threshold indicating/statistically [Tailiang teaches at the Abstract in one embodiment, exact type I error rate control, median unbiased estimate of treatment effect, and exact two-sided confidence interval can be continuously calculated. Tailiang teaches at pg. 6 at line C (end of trial), many trails are below the “success” threshold p>0.05 and are considered invalid. Collectively, this teaches that the error rate satisfies a statistical significance threshold.]
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of Tailiang with teaching of Schaefer since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the statistical threshold of the secondary reference(s) for the determination means of the primary reference. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Regarding Claim 15
Due to its similarity to Claim 1, Claim 15 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
Regarding Claim 8
McNair teaches:
A system comprising: a computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface configured to: receive, by the computing device, patient data; [McNair teaches at col. 10 line 45-line 50 system comprises one or more computing devices, such as a server, desktop computer, laptop, or tablet, cloud-computing device or distributed computing architecture, a portable computing device such as a laptop, tablet, ultra-mobile P.C., or a mobile phone. The mobile phone in interpreted to teach the input and conclusion interface, surveillance interface and framework specification interface. McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. Collectively, this teaches a system comprising: a computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface configured to: receive, by the computing device, patient data.]
determining, by a decision specification controller, based on the patient data, a care decision logic, [McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4530 determining a first set of clinical concepts associated with the first patient. This teaches determining, based on the patient data, a care decision logic. ]
[…]
executing, by a programmatic decision controller, based on the patient data, the care decision logic to determine a care conclusion, [McNair teaches at col. 67 line 61 through col. 68 line 14 that in one aspect of the embodiments described herein, there is provided a system, method, or computer-readable media for providing clinical decision support, comprising: receiving a first set of clinical information associated with a patient from a data store; based on the first set of clinical information, determining a likelihood of a clinical decision support event being associated with the patient; accessing an assessment associated with the clinical decision support event, the assessment including a set of patient related questions; determining from the set of patient related questions; determining from the set of questions a portion of the questions to include in a questionnaire, based on a treatment session context and the first set of clinical information; generating a user interface for presenting the questionnaire; presenting the user interface to a user and receiving a set of answers, via one or more clinical information elements of the user interface, in response to the portion of questions in the questionnaire.]
[…]
receiving, by the computing device, a treatment history comprising one or more historical treatments; [McNair teaches at col. 67 line 61 through col. 68 line 14 that in one aspect of the embodiments described herein, there is provided a system, method, or computer-readable media for providing clinical decision support, comprising: receiving a first set of clinical information associated with a patient from a data store; based on the first set of clinical information, determining a likelihood of a clinical decision support event being associated with the patient; accessing an assessment associated with the clinical decision support event, the assessment including a set of patient related questions; determining from the set of patient related questions; determining from the set of questions a portion of the questions to include in a questionnaire, based on a treatment session context and the first set of clinical information; generating a user interface for presenting the questionnaire; presenting the user interface to a user and receiving a set of answers, via one or more clinical information elements of the user interface, in response to the portion of questions in the questionnaire. The answers received via the questionnaire are interpreted to be receiving a treatment history comprising one or more historical treatments.]
McNair may not explicitly teach:
wherein determining the care decision logic comprises processing decision specification including decision inputs and decision conclusions received via the framework specification interface
and writing the processed decision specification to a decision parameter and logic storage;
wherein executing the care decision logic comprises retrieving decision framework parameters from the decision parameter and logic storage,
generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters, determining based on executing the care decision logic and care conclusion, one or more programmatic treatments;
and determining, by a conclusion accuracy controller, based on the treatment history, an error rate, wherein the error rate comprises a difference between the one or more programmatic treatments and the one or more historical treatments;
and determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way
and a display device configured to: output the care conclusion.
Lobach teaches:
wherein determining the care decision logic comprises processing decision specification including decision inputs and decision conclusions received via the framework specification interface [Lobach teaches at para. [0072] each module includes a specification of the data requirements for assessing a patient, the patient-specific conclusions that will be returned by the module, and the logic that will be utilized to generate the conclusions using the specified patient data. Lobach further teaches at para. [0073] with Sebastian configured as a Web service, service will be accessed by sending XML requests over HTTP or HTTPs (HTTP over secure socket layer). Lobach teaches at para. [0073] the system will be configured and operated to provide a patient evaluation service as a core service, in which patient data elements are received as the input and machine-interpretable decision support results are returned as the output. Lobach teaches at para. [0082] once the EKMs are encoded, the decision logic will be processed and delivered by a software service that utilizes a standards-based input/output interface to efficiently integrate machine-executable decision logic into various medical software applications.]
and writing the processed decision specification to a decision parameter and logic storage; [Lobach teaches at para. [0072] medical knowledge in the clinical decision support system is captured in XML documents known as Executable Knowledge Modules (EKMs), which are also sometimes therein referred to as Patient Safety Modules. Lobach teaches at para. [0072] each module includes a specification of the data requirements for assessing a patient, the patient-specific conclusions that will be returned by the module, and the logic that will be utilized to generate the conclusions using the specified patient data. Collectively, this teaches and writing the processed decision specification to a decision parameter and logic storage.]
wherein executing the care decision logic comprises retrieving decision framework parameters from the decision parameter and logic storage, [Lobach teaches at para. [0120] the framework will be adapted so that knowledge modules will return various type of machine interpretable result parameters following patient evaluation. Lobach at para. [0126] teaches the use of a standard data storage standard such as XML allows the executable knowledge modules to be edited using powerful standards-based tools. This teaches wherein executing the care decision logic comprises retrieving decision framework parameters from the decision parameter and logic storage.]
generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters, determining based on executing the care decision logic and care conclusion, one or more programmatic treatments; [Lobach teaches at claim 31 the system of claim 3, wherein said patient evaluation service returns machine-interpretable results that comprise at least one of the following: a unique result code, a patient-specific assessment message, a patient-specific recommendation message, and zero or more result parameters. This teaches generating a decision instance with a unique identifier (the unique result code), determining based on executing the care decision logic and care conclusion, one or more programmatic treatments (the patient specific recommendation message) and using the decision framework parameters (zero or more result parameters).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the clinical decision support system using phenotypic features of McNair to the clinical decision support system of Lobach with the motivation of permitting re-use of executable medical knowledge across diverse applications and care settings, easy authoring of knowledge modules, and use of the system framework to implement decision support applications having significant clinical utility (Lobach at the Abstract).
McNair/Lobach may not explicitly teach:
[…]
and determining, by a conclusion accuracy controller, based on the treatment history, an error rate, wherein the error rate comprises a difference between the one or more programmatic treatments and the one or more historical treatments;
and determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way;
and a display device configured to: output the care conclusion.
Schaefer teaches the following:
and determining, by a conclusion accuracy controller, based on the treatment history, an error rate, wherein the error rate comprises a difference between the one or more programmatic treatments and the one or more historical treatments; [Schaefer teaches at Figure 3 Item 304 receiving/updating patient medical information with portable electronic device and at item 306 administering pre-treatment medication. Schaefer teaches at Figure 3 Item 308 assessing condition of the patient before treatment. This teaches assessing a treatment administered by a program/computer. Schaefer teaches at Figure 3 receiving at portable electronic device instructions from a doctor, item 324 implementing doctor instructions and at Item 326 assessing condition of patient after implementing doctor instructions. This teaches assessing a treatment administered by a doctor. Schaefer teaches at para. [0014] the computer program will further comprise a code segment for comparing the post-treatment patient data to the pre-treatment patient data and/or the treatment patient data and for identifying changes in the condition of the patient based on the comparison. Schaefer teaches at para. [0058] the computer program will further comprise a code segment for determining if the changes in the condition of the patient are greater than a threshold amount, and if they are, transmitting data representative of the changes to the remote computer. Determining if the changes in the condition of the patient are greater than a threshold amount teaches the difference between the one or more programmatic treatments and the one or more historical treatments.]
and a display device configured to: output the care conclusion. [Schaefer teaches at para. [0057] alternatively, the computer program will notify the doctor and pharmacist of the conflicting instructions, via the remote computer, and display the instructions on the portable electronic device only after the doctor has reviewed, approved, or modified the instructions. This teaches a display device configured to: output the care conclusion.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the clinical decision support system using phenotypic features of McNair to the clinical decision support system of Lobach to the computer program, method, and system for pharmacist-assisted treatment of patients of Schaefer with the motivation of addressing the lack of awareness and treatment of CIDP, which is also due to limitations of clinical trials. (Schaefer at para. [0004]).
McNair/Lobach/Schaefer may not explicitly teach:
and determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way.
Schaefer teaches the following noted feature:
and determining […] the care decision logic performs equivalently to or better than human medical practitioners in a […] significant way. [Schaefer teaches at Figure 3 Item 304 receiving/updating patient medical information with portable electronic device and at item 306 administering pre-treatment medication. Schaefer teaches at Figure 3 Item 308 assessing condition of the patient before treatment. This teaches assessing a treatment administered by a program/computer. Schaefer teaches at Figure 3 receiving at portable electronic device instructions from a doctor, item 324 implementing doctor instructions and at Item 326 assessing condition of patient after implementing doctor instructions. This teaches assessing a treatment administered by a doctor. Schaefer teaches at para. [0014] the computer program will further comprise a code segment for comparing the post-treatment patient data to the pre-treatment patient data and/or the treatment patient data and for identifying changes in the condition of the patient based on the comparison. Collectively, this teaches indicating the care decision logic performs equivalently to or better than human medical practitioners in a […] significant way.]
Tailiang teaches the following noted feature:
that the error rate satisfies a statistical significance threshold indicating/statistically [Tailiang teaches at the Abstract in one embodiment, exact type I error rate control, median unbiased estimate of treatment effect, and exact two-sided confidence interval can be continuously calculated. Tailiang teaches at pg. 6 at line C (end of trial), many trails are below the “success” threshold p>0.05 and are considered invalid. Collectively, this teaches that the error rate satisfies a statistical significance threshold.]
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of Tailiang with teaching of Schaefer since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the statistical threshold of the secondary reference(s) for the determination means of the primary reference. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Regarding Claim 2
McNair/Lobach/Schaefer/Tailiang teach the method of claim 1. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the patient data comprises at least one of: a survey or an electronic health record. [McNair teaches at col. 67 line 61 through col. 68 line 14 that in one aspect of the embodiments described herein, there is provided a system, method, or computer-readable media for providing clinical decision support, comprising: receiving a first set of clinical information associated with a patient from a data store; based on the first set of clinical information, determining a likelihood of a clinical decision support event being associated with the patient; accessing an assessment associated with the clinical decision support event, the assessment including a set of patient related questions; determining from the set of patient related questions; determining from the set of questions a portion of the questions to include in a questionnaire, based on a treatment session context and the first set of clinical information; generating a user interface for presenting the questionnaire; presenting the user interface to a user and receiving a set of answers, via one or more clinical information elements of the user interface, in response to the portion of questions in the questionnaire. The answers received via the questionnaire are interpreted to be wherein the patient data comprises at least one of: a survey or an electronic health record.]
Regarding Claim 3
McNair/Lobach/Schaefer/Tailiang teach the method of claim 1. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the care decision logic is associated with an identifier and wherein the identifier is associated with an ICD code. [McNair teaches at Figure 6B a run query window that contains ICD9 Code 250.02, interpreted to be an ICD code associated with the identifier.]
Regarding Claim 4
McNair/Lobach/Schaefer/Tailiang teach the method of claim 1. McNair/Lobach/Schaefer/Tailiang further teach:
wherein determining the care decision logic comprises: receiving a user input; and determining, based on the user input, the decision logic. [McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4530 determining a first set of clinical concepts associated with the first patient. The clinical concepts associated with the first patient are interpreted to be a care decision logic. Collectively, this teaches receive a user input; and determining, based on the user input, the care decision logic.]
Regarding Claim 6
McNair/Lobach/Schaefer/Tailiang teach the method of claim 1. McNair/Lobach/Schaefer/Tailiang further teach:
further comprising: determining the error rate satisfies an error rate threshold; and outputting, based on the error rate satisfying the error rate threshold, a message. [Schaefer teaches at Figure 3 Item 304 receiving/updating patient medical information with portable electronic device and at item 306 administering pre-treatment medication. Schaefer teaches at Figure 3 Item 308 assessing condition of the patient before treatment. This teaches assessing a treatment administered by a program/computer. Schaefer teaches at Figure 3 receiving at portable electronic device instructions from a doctor, item 324 implementing doctor instructions and at Item 326 assessing condition of patient after implementing doctor instructions. This teaches assessing a treatment administered by a doctor. Schaefer teaches at para. [0014] the computer program will further comprise a code segment for comparing the post-treatment patient data to the pre-treatment patient data and/or the treatment patient data and for identifying changes in the condition of the patient based on the comparison. Schaefer teaches at para. [0058] the computer program will further comprise a code segment for determining if the changes in the condition of the patient are greater than a threshold amount, and if they are, transmitting data representative of the changes to the remote computer. This teaches determining the error rate satisfies an error rate threshold.]
Regarding Claim 13 and 19
Due to their similarity to Claim 6, Claim 13 and 19 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 6.
Regarding Claim 9
McNair/Lobach/Schaefer/Tailiang teach the system of claim 8. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the patient data comprises at least one of: a survey or an electronic health record. [McNair teaches at col. 67 line 61 through col. 68 line 14 that in one aspect of the embodiments described herein, there is provided a system, method, or computer-readable media for providing clinical decision support, comprising: receiving a first set of clinical information associated with a patient from a data store; based on the first set of clinical information, determining a likelihood of a clinical decision support event being associated with the patient; accessing an assessment associated with the clinical decision support event, the assessment including a set of patient related questions; determining from the set of patient related questions; determining from the set of questions a portion of the questions to include in a questionnaire, based on a treatment session context and the first set of clinical information; generating a user interface for presenting the questionnaire; presenting the user interface to a user and receiving a set of answers, via one or more clinical information elements of the user interface, in response to the portion of questions in the questionnaire. The answers received via the questionnaire are interpreted to be wherein the patient data comprises at least one of: a survey or an electronic health record.]
Regarding Claim 10
McNair/Lobach/Schaefer/Tailiang teach the system of claim 8. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the care decision logic is associated with an identifier and wherein the identifier is associated with a condition. [McNair teaches at Figure 6B a run query window that contains ICD9 Code 250.02, interpreted to be an identifier and wherein the identifier is associated with a condition.]
Regarding Claim 11
McNair/Lobach/Schaefer/Tailiang teach the system of claim 8. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the computing device configured to determine the care decision logic is further configured to: receive a user input; and determine, based on the user input, the care decision logic. [McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4530 determining a first set of clinical concepts associated with the first patient. The clinical concepts associated with the first patient are interpreted to be a care decision logic. Collectively, this teaches receive a user input; and determining, based on the user input, the care decision logic.]
Regarding Claim 16
McNair/Lobach/Schaefer/Tailiang teach the apparatus of claim 15. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the patient data comprises at least one of: a survey or an electronic health record. [McNair teaches at col. 67 line 61 through col. 68 line 14 that in one aspect of the embodiments described herein, there is provided a system, method, or computer-readable media for providing clinical decision support, comprising: receiving a first set of clinical information associated with a patient from a data store; based on the first set of clinical information, determining a likelihood of a clinical decision support event being associated with the patient; accessing an assessment associated with the clinical decision support event, the assessment including a set of patient related questions; determining from the set of patient related questions; determining from the set of questions a portion of the questions to include in a questionnaire, based on a treatment session context and the first set of clinical information; generating a user interface for presenting the questionnaire; presenting the user interface to a user and receiving a set of answers, via one or more clinical information elements of the user interface, in response to the portion of questions in the questionnaire. The answers received via the questionnaire are interpreted to be wherein the patient data comprises at least one of: a survey or an electronic health record.]
Regarding Claim 17
McNair/Lobach/Schaefer/Tailiang teach the apparatus of claim 15. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the care decision logic is associated with an identifier and wherein the identifier is associated with a condition. [McNair teaches at Figure 6B a run query window that contains ICD9 Code 250.02, interpreted to be an identifier and wherein the identifier is associated with a condition.]
Regarding Claim 18
McNair/Lobach/Schaefer/Tailiang teach the apparatus of claim 15. McNair/Lobach/Schaefer/Tailiang further teach:
wherein the processor executable instructions, when executed by the one or more processors, further cause the apparatus to: receive a user input; and determine, based on the user input, the care decision logic. [McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4510 receiving unstructured health information associated with a first patient, including a discrete data element. McNair teaches at Figure 4F Item 4530 determining a first set of clinical concepts associated with the first patient. The clinical concepts associated with the first patient are interpreted to be a care decision logic. Collectively, this teaches receive a user input; and determining, based on the user input, the care decision logic.]
Claim(s) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 11183302 B1 (hereafter McNair) in view of US 2007/0112782 A1 (Lobach) in view of US 2014/0156297 A1 (hereafter Schaefer) in view of TW I819049 B (hereafter Tailiang).
in view of US 2021/0174503 A1 (hereafter Trautwein).
Regarding Claim 5
McNair/Lobach/Schaefer/Tailiang teach the method of claim 1. McNair/Lobach/Schaefer/Tailiang further teach:
[…]
and outputting, based on the error rate satisfying the error rate threshold, a message. [Lobach teaches at claim 31 the system of claim 3, wherein said patient evaluation service returns machine-interpretable results that comprise at least one of the following: a unique result code, a patient-specific assessment message, a patient-specific recommendation message, and zero or more result parameters. The message of Lobach is interpreted to be based on the error rate satisfying the error rate threshold of Tailiang (taught elsewhere).]
McNair/Lobach/Schaefer/Tailiang may not explicitly teach:
wherein determining the decision logic comprises: determining, based on the one or more inputs, metadata associated with the input;
and selecting, based on the metadata, and from a database, the decision logic.
Trautwein teaches:
wherein determining the decision logic comprises: determining, based on the one or more inputs, metadata associated with the input; [Trautwein teaches at para. [0049] that in order to subsequently process the images, the metadata has to be stored consistent to at least one terminology or similar scheme, allowing programmatic references and processes to analyze the metadata for logic decision triggers.]
and selecting, based on the metadata, and from a database, the decision logic. [Trautwein teaches at para. [0049] that in order to subsequently process the images, the metadata has to be stored consistent to at least one terminology or similar scheme, allowing programmatic references and processes to analyze the metadata for logic decision triggers.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the clinical decision support system using phenotypic features of McNair to the clinical decision support system of Lobach to the computer program, method, and system for pharmacist-assisted treatment of patients of Schaefer to the systems, methods and processes for dynamic data monitoring and real-time optimization of ongoing clinical research trials of Tailiang to the to the with the motivation of determining the efficacy of programmatic treatments of Trautwein with the motivation of improving the diagnosis, treatment decision, follow up of a treatment or the planning of surgical interventions by addressing the need for the exact knowledge of geometric dimensions, distances, angles, areas or volumes of organs, vessels, bony structure, or the pathological changes of these structures (e.g., by a tumor) is often necessary (Trautwein at para. [0003]).
Regarding Claim 12
McNair/Lobach/Schaefer/Tailiang teach the system of claim 8. McNair/Lobach/Schaefer/Tailiang may not explicitly teach:
wherein the computing device configured to determine the care decision logic is further configured to: determining, based on the one or more inputs, metadata associated with the input; and selecting, based on the metadata, and from a database, the decision logic.
Trautwein teaches:
wherein the computing device configured to determine the care decision logic is further configured to: determining, based on the one or more inputs, metadata associated with the input; and selecting, based on the metadata, and from a database, the decision logic. [Trautwein teaches at para. [0049] that in order to subsequently process the images, the metadata has to be stored consistent to at least one terminology or similar scheme, allowing programmatic references and processes to analyze the metadata for logic decision triggers.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the clinical decision support system using phenotypic features of McNair to the clinical decision support system of Lobach to the computer program, method, and system for pharmacist-assisted treatment of patients of Schaefer to the systems, methods and processes for dynamic data monitoring and real-time optimization of ongoing clinical research trials of Tailiang to the to the with the motivation of determining the efficacy of programmatic treatments of Trautwein with the motivation of improving the diagnosis, treatment decision, follow up of a treatment or the planning of surgical interventions by addressing the need for the exact knowledge of geometric dimensions, distances, angles, areas or volumes of organs, vessels, bony structure, or the pathological changes of these structures (e.g., by a tumor) is often necessary (Trautwein at para. [0003]).
Response to Arguments
35 U.S.C. 101 Argument Responses
Applicant respectfully submits that the amendments to independent claims 1,8 and 15 integrate the claimed subject matter into a practical application by reciting specific technical architecture and processing implementation that goes beyond merely applying an abstract idea using generic computer components. Specifically, claim 1 as amended now recites “a computing device comprising a framework specification interface, an input and conclusion interface, and a surveillance interface” that work together to implement the care decision functionality. This specific architecture is not a generic computer implementation but rather represents a particular machine configuration integral to the claimed method.
The Examiner disagrees.
MPEP 2106.05(b) Particular Machine indicates the following items are particularly relevant considerations:
The particularity or generality of the elements of the machine or apparatus.
Whether the machine or apparatus implements the steps of the method.
Whether its involvement is extra-solution activity or a field of use.
First, the particularity or generality of the recitation of the machine or apparatus was considered. Applicant teaches at para. [0089] of the specification that the processing of the described methods and systems can be performed by software components. Applicant also teaches at para. [0089] of the Specification that the described systems and methods can be described in the general context of computer executable instructions, such a program modules, being executed by one or more computers or other devices. Applicant also teaches at para. [0088] of the Specification examples of well-known computing systems, environments, and/or configurations that can be suitable for use with the systems and methods comprise, but are not limited to, personal computers, server computers, laptop devices, and multiprocessor systems. Applicant teaches at para. [0089] of the Specification generally, program modules comprise computer code, routines, programs, objects, components, data structure, etc. Moreover, Applicant states at para. [0089] of the Specification program modules can be located in both local and remote computer storage media including memory storage devices. In sum, Applicant indicates at para. [0090] of the Specification the system memory is coupled to processor(s). Applicant teaches at para. [0098] of the Specification that for the purposes of illustration, application programs and other executable program components, such as the operating system are illustrated herein as discrete blocks, although it is recognized that such programs and components reside at various times in different storage components of the computing device, and are executed by the data processor(s) of the computer. In sum, the computer components were described with a high degree of generality, such that they consist of modules consisting of generic computer components (for example, memory coupled to processing unit(s)) running software.
Next, the question of whether the machine or apparatus implemented the steps of the method was considered. MPEP 2106.05(b) Particular Machine Item II. Whether the Machine or Apparatus Implements the Steps of the Methods indicates that integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must "play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly"). The machine is not integral to the claims.
Finally, whether the involvement of the machine is extra-solution activity or a field of use was considered. Field-of-use is the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. MPEP 2106.05(h) Field of Use and Technological Environment Indicates as explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." This same section indicates that limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.
MPEP 2106(I) states that “[t]he programmed computer or ‘special purpose computer’ test of In re Alappat, 33 F.3d 1526, 31 USPQ2d 1545 (Fed. Cir. 1994) (i.e., the rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim for the ‘special purpose’ of executing the algorithm or software) was also superseded by the Supreme Court’s Bilski and Alice Corp. decisions. MPEP 2106.05(b)(I) states that the Examiner should determine whether the additional elements of the claim provide a practical application or significantly more that the judicial exception based on one or more of the measures in MPEP 2106.04 and/or MPEP 2105.05. Because neither a practical application nor significantly more is present, the claims are not subject matter eligible.
Thus the use of a computer does not amount to a particular machine configuration integral to the claimed method as claimed by Applicant, at least in this case.
Furthermore, claim 1 as amended recites specific processing performed “by a decision specification controller” including “processing decision specifications including decision inputs an decision conclusions received via the framework specification interface and writing the processed decision specification to a decision parameter and logic storage.” This technical processing and storage functionality demonstrates integration into a practical application through a particular machine implementation that goes beyond generic computer functions.
Please see the response above, which answers this redundant argument.
The claim as amended also recites detailed processing “by a programmatic decision controller” including “retrieving decision framework parameters from the decision parameter logic storage, generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters.” These specific technical steps show how the abstract idea is integrated into a particular computerized implementation with meaningful technical limitations.
The Examiner disagrees.
The cited limitation “retrieving decision framework parameters from the decision parameter logic storage, generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters” contains additional elements (for example, the decision parameter logic storage) and the rest was determined to be part of the abstract idea.
Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
The Examiner asserts there is no improvement to the computer or any other technology recited in the claims. There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a). To show that the involvement of a computer assists in improving the technology, the claims must recite the details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art.
The invention determines programmatic treatments and compares their efficacy to human practitioners by (to summarize): receiving patient data, determining a care decision logic by determining the set of logical operations which are applied to all the information that is incorporated and processed within a decision framework to reach a care conclusion, executing decision logic (applying the care decision logic to the patient data such as, making a decision to prescribe a medication to the patient, enrolling the patient in a therapy or rehabilitation program, directing a patient to receive additional diagnostics or consultations or any other direction of the care for the patient by retrieving decision framework parameters from the decision parameter and logic storage, generating a decision instance with a unique identifier, and processing the patient data using the decision framework parameters), determining programmatic treatments and receiving treatment history and determining the error rate (for example by determining the difference between the one or more programmatic treatments and the one or more historical treatments in the manner specifically recited) and determining that the error rate satisfies a statistical significant threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way. The invention is computer implemented. In this case computer components merely accelerate/automate the method identified.
For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must "play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly").
There is no application of or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). There is no implementation of a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b) and detailed in the argument above. There is no effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c). There is no applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claim as a whole is no more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Finally phrase "meaningful limitations" has been used by the courts even before Alice and Mayo in various contexts to describe additional elements that provide an inventive concept to the claim as a whole. The considerations described in MPEP § 2106.05(a)-(d) are meaningful limitations when they amount to significantly more than the judicial exception, or when they integrate a judicial exception into a practical application. These considerations have been addressed already.
Additionally, claim 1 as amended recites “determining, by a conclusion accuracy controller, based on the treatment history, an error rate” and “determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way.” This conclusion accuracy controller works in conjunction with the other technical components to provide a complete system architecture that implements the judicial exception using a particular machine configuration.
Please see the first response as it answers this redundant argument.
The specific interface architecture, controller processing steps, and data storage functionality recite by claim 1 as amended implement the care decision logic using particular machine components rather than generic computers, thereby integrating the claimed subject matter into a practical application. Claims 8 and 15 as amended recite similar technical architecture and processing details that similarly integrate the claimed subject matter into a practical application.
Please see the first response as it answers this redundant argument.
35 U.S.C. 103 Argument Responses
Applicant respectfully submits that the combination of McNair and Pappada fails to teach or suggest the limitation "determining that the error rate satisfies a statistical significance threshold indicating the care decision logic performs equivalently to or better than human medical practitioners in a statistically significant way" are recited by claim 1 as amended.
Please see the updated 35 U.S.C. 103 rejection Schaefer and Tailiang were used to teach the necessary limitations.
The examiner has alleged that the similarity rating of Pappada corresponds to the error rate recited by claim 1 as amended.
Please see the updated 35 U.S.C. 103 rejection, which now relies on Schaefer to teach the limitation.
Applicant argues that Pappada does not teach the disclosed features.
Note that Pappada has been removed from the rejection and replaced with art as was necessary to accommodate the claim amendments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2019/0341153 A1 (hereafter Ng et al.)
Karsh, Ben-Tzion. "Clinical practice improvement and redesign: how change in workflow can be supported by clinical decision support." (2009).
Both prior arts teach on the general subjects of clinical decision support and clinical workflows.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/T.I.E./Examiner, Art Unit 3683 /CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683