DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 6 February, 2024.
A preliminary amendment to the claims, filed on 2 February, 2024 was not entered. See the Notice of Insufficiency mailed on 26 July, 2024.
Claims 1 – 24 have been cancelled, and Claims 25 – 44 have been added by an amendment filed on 25 August, 2024.
Claims 25 - 44 are currently pending and have been examined.
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 .
Claim Objections
Claim 26 is objected to because of the following informalities: Claim 26 depends from cancelled Claim 1. Examiner assumes that Claim 26 properly depends from Claim 25. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: The preamble of Claim 29 recites: “A clinical decision support system according to 28”. The word “claim” is missing, where the preamble should recite: “A clinical decision support system according to claim 28”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 27 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 27 recites the limitation “wherein at least one of the tests is selected and performed”. There is insufficient antecedent basis for this limitation in the claim, and in particular, for the term “the tests”. Appropriate correction is required.
Here, Examiner notes that the limitation: “wherein at least one of the tests is selected and performed” appears to belong between: “generate a hierarchy of usefulness” and the last “wherein” clause, which would obviate this rejection.
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.
The following rejection is formatted in accordance with MPEP 2106.
Claim 25 is independent. Claim 25 recites:
A clinical decision support system comprising
a data input means and memory to receive and store a first group of data specific to at least one individual and a second group of data related to health conditions, and
a data analyzer to relate the first group to the second group to infer a specific propensity of the individual(s) to a health condition.
Claims 25 - 44 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), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a device, a method and non-transitory computer readable medium which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 25, recite limitations that encompass an abstract idea including:
relate the first group to the second group to infer a specific propensity of the individual(s) to a health condition.
The claims, as illustrated by Claim 25, recite limitations that encompass an abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion. The claims recite receiving and storing a first group of data specific to an individual and a second group of data related to health conditions, and relating the first and second data groups to infer an individual’s propensity to a health condition. The specification discloses that the first data specific to an individual includes patient demographics, medical data such as medical history, clinical indications, biomarkers, genetic factors, medications; and non-medical data including geographic and lifestyle data. The second data related to health conditions includes symptoms, procedures to test for health conditions and suspected diagnosis. The first and second data is related by performing “a comparative analysis”. Comparing data specific to an individual to data relating to health conditions to infer a propensity of a health condition for an individual, is a process that, except for generic computer implementation steps, can be performed in the human mind.
Collecting information, including when limited to particular content, is within the realm of abstract ideas, and analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, are mental processes within the abstract idea category (Electric Power Group v. Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016).
The specification discloses that making a medical diagnosis involve clinical judgement, even when there is a misdiagnosis. As such, the claims recite an abstract idea within the mental process grouping.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “certain methods of organizing human activity” grouping –
managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite receiving and storing a first group of data specific to an individual and a second group of data related to health conditions, and relating the first and second data groups to infer an individual’s propensity to a health condition. This type of activity, i.e. collecting patient data and reference data and comparing patient data to reference data to render a diagnosis, includes conduct that would normally occur when managing a patient’s particular disease, medical condition or state. MPEP 2106.04(a)(2) II C indicates that “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions”, (In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)) falls into this category of abstract ideas. As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
STEP 2A PRONG TWO
The claims recite limitations that include additional elements beyond those that encompass the abstract idea above including:
A clinical decision support system comprising a data input means and memory, and a data analyzer;
receive and store a first group of data specific to at least one individual and a second group of data related to health conditions.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05)
The clinical decision support system, input means and memory, as well as the data analyzer are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using a generic computer component. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. The specification discloses that the recited method is performed by a clinical decision support platform – i.e. a computer based diagnostic decision support tool.
Receiving and storing first and second groups of data is an insignificant extras-solution data gathering step. Nothing in the claim recites specific limitations directed to an improved computer system, processor, memory, network, database or Internet. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract diagnostic process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract diagnostic process. Receiving data is a well-understood, routine and conventional computer function – i.e. receiving or transmitting data over a network as in Symantec, TLI, OIP and buySAFE. Similarly, storing and retrieving information from memory is a routine and conventional computer function as in Versata and OIP Tech.
The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure (i.e. A clinical decision support system comprising a data input means and memory, and a data analyzer). Each of the above components are disclosed in the specification as being purely conventional and/or known in the industry. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting well-understood, routine and conventional computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently well-known that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually. As such, the additional elements recited in the claim do not provide significantly more than the abstract diagnostic process, or an inventive concept.
The dependent claims add additional features including:
those that merely serve to further narrow the abstract idea above such as:
further limiting the data to a multi-modal type (Claim 38);
those that recite additional abstract ideas such as:
parse structured data from unstructured data; (Claim 26);
generate lists of tests and determine their usefulness (Claim 27);
clustering states by individual or practitioner based on similarity and assigned weights, (Claim 31 - 37);
selecting a clinical pathway (Claim 44);
those that recite well-understood, routine and conventional activity or computer functions such as:
receive and store information (Claims 29, 30);
display information including overlays and labels (Claims 39 - 41);
a touch screen to display information relative to a touched element; (Claim 42 - 43);
those that recite insignificant extra-solution activities such as:
generating a state-transition chain (Claim 28);
or those that are an ancillary part of the abstract idea.
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. These elements merely narrow the abstract idea, recite additional abstract ideas, or append conventional activity to the abstract process. As such, the additional element do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention.
Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 25 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Li et al.: (US PGPUB 2023/0043676 A1).
CLAIM 25
Li discloses a system and method for diagnosing a medical condition that includes the following limitations:
A clinical decision support system comprising a data input means and memory; (Li 0063, 0092 – 0094, 0098, 0099, 0103);
to receive and store a first group of data specific to at least one individual and a second group of data related to health conditions; (Li 0020 – 0022, 0024, 0026, 0027, 0054 – 0057, 0062); and
a data analyzer to relate the first group to the second group to infer a specific propensity of the individual(s) to a health condition; (Li 0022, 0054, 0058, 0080).
Li discloses a clinical decision support system configured with input devices and a memory to receive and store data specific to a patient, and domain knowledge data related to health conditions. The data is applied to a prediction model (i.e. a data analyzer) trained to analyze the data to predict a medical condition (i.e. infer a specific propensity of the individual(s) to a health condition).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al.: (US PGPUB 2023/0043676 A1) in view of Shreve: (US PGPUB 2003/0154071 A1).
CLAIM 26
Li discloses the limitations above relative to Claim 25. With respect to the following limitations:
wherein the data analyzer is configured to parse structured data from unstructured medical reports in the second group of data; (Shreve 0015, 0061, 0114).
Li discloses extracting data from records but does not disclose parsing. Shreve discloses parsing documents including medical records to generate structured data from unstructured data by applying a tag. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the diagnostic system of Li so as to have included parsing medical records for input data, in accordance with the teaching of Shreve, in order to allow for analysis of unstructured medical records.
Claims 27 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al.: (US PGPUB 2023/0043676 A1) in view of Barford: (US PGPUB 2003/0139906 A1).
CLAIMS 27 and 44
Li discloses the limitations above relative to Claim 25. With respect to the following limitations:
generate a first list of medical tests relevant to the health condition; relate the first and second group to each one of the medical tests and provide a probability of a particular result respective of each one of the medical tests; determine a probability of usefulness of the particular result of each one of the medical tests; and generate a hierarchy of usefulness of the tests based on a probability of usefulness of the particular result; wherein at least one of the tests is selected and performed; (Barford 0008 – 0017, 0041, 0059);
wherein the clinical decision support system is configured to note usefulness of the result(s) is/are noted, and feedback the first list of medical tests and usefulness of the test result(s) is/are fed back to the data analyzer; (Barford 0032, 0041);
A method of selecting a clinical pathway using the clinical decision support system according to claim 25; (Barford 0041).
Li does not disclose generating a list of tests, and a probability of a correct diagnosis for each test in the list – i.e. a usefulness. Barford discloses selecting and implementing suggested tests. Barford uses actual historical results of prior tests to improve the system. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the diagnostic system of Li so as to have included listing tests that can confirm a diagnosis, in accordance with the teaching of Barford, in order to eliminate unnecessary tests.
Claims 28 - 30 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al.: (US PGPUB 2023/0043676 A1) in view of Kupershmidt et al.: (US PGPUB 2020/0194121 A1).
CLAIMS 28 - 30
Li discloses the limitations above relative to Claim 25. With respect to the following limitations:
wherein the data analyzer is configured to generate a State-Transition chain in which states of the individual at respective times are interleaved by a transition made by a practitioner; (Kupershmidt 0004, 0024, 0027, 0028, 0030, 0031, 0042, Figure 4A)
wherein the data input means and memory are configured to receive and store the states in the first group of data, wherein each state comprises multiple multi-modal containing information about a respective one of the individuals at the respective time; (Kupershmidt 0016, 0017, 0022);
wherein the data input means and memory are configured to receive and store each transition in first group of data, wherein each transition comprises a diagnosis by the practitioner based on a state before the transition and an actions recommended by the practitioner based on the diagnosis; (Kupershmidt 0016, 0017, 0022).
Li does not disclose a state-transition chain – a time line of patient states interleaved with a diagnosis and recommended actions – i.e. a care pathway. Kupershmidt discloses a personalized temporal health model that includes displaying a timeline of patient status and diagnosis and treatment actions. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the diagnostic system of Li so as to have included displaying a temporal treatment pathway, in accordance with the teaching of Kupershmidt, in visualize the pathway for a patient better understanding.
Claims 31 – 37 and 38 - 41 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al.: (US PGPUB 2023/0043676 A1) in view of Kupershmidt et al.: (US PGPUB 2020/0194121 A1) in view of Friedlander et al.: (US PGPUB 2008/0082356 A1).
CLAIMS 31 - 37
The combination of Li/Kupershmidt discloses the limitations above relative to Claim 29. With respect to the following limitations:
wherein the data analyzer is configured to form in the memory at least one cluster of the states, wherein each of the states in the cluster comprises data specific to a different individual and the data for each state is similar; wherein the data analyzer is configured to include states in each cluster which comprise data specific to a different individual; wherein the data analyzer is configured to include states in each cluster which comprise data specific to a different practitioner; wherein the data analyzer is configured to quantify similarity of each state relative to the other states, and to place states with a similarity above a particular level in a cluster; wherein the data analyzer is configured to assign a particular weight to a particular one of the data specific to at least one individual to influence the similarity of each state relative the other states; wherein the data input means and memory are configured to receive and store the weight as assigned by a practitioner; wherein the data input means and memory are configured to receive and store the weight as assigned by the data analyzer parse of data in the first group and/or the second group; (Friedlander 0030, 0033 – 0048, Figure 4A, 4B).
Li does not disclose clustering. Friedlander discloses a system and method for clustering individual patient records based on a patient disease state, where a common disease state is assigned to the same cluster based on a weighted similarity score or distance. Friedland discloses clustering patient’s in a population of patients. These patients inherently include data specific to different individuals and practitioners. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the diagnostic system of Li/Kupershmidt so as to have included common clustering techniques, in accordance with the teaching of Barford, in order to improve data analysis.
CLAIMS 38 and 39
The combination of Li/Kupershmidt/Friedlander discloses the limitations above relative to Claim 31. Additionally, Kupershmidt discloses the following limitations:
wherein different types of multi-modal data are linked to the structure of the state and transition; (Kupershmidt 0015 – 0017, 0022);
a display in communication with the data analyzer and memory to provide a visible graph of the State-Transition chain(s); (Kupershmidt 0024, 0042 – 0047).
Kupershmidt discloses liking multiple data types and displaying the pathway. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the diagnostic system of Li/Friedlander so as to have included analyzing multiple data types and displaying results, in accordance with the teaching of Kupershmidt, in order to eliminate unnecessary tests.
CLAIMS 40 and 41
The combination of Li/Kupershmidt/Friedlander discloses the limitations above relative to Claim 33. Additionally, Friedlander discloses the following limitations:
wherein the data analyzer is configured to overlay the cluster(s) to clarify which states are within which cluster; wherein the/each state is labeled with a visible tag by date or time of data associated with the state; (Friedlander 0030, 0033 – 0048, Figure 4A, 4B).
Li does not disclose clustering. Friedlander discloses a system and method for clustering individual patient records based on a patient disease state, where a common disease state is assigned to the same cluster based on a weighted similarity score or distance. Clustered are graphically overlaid with circles Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the diagnostic system of Li/Kupershmidt so as to have included graphically indicating clusters, in accordance with the teaching of Friedlander, in order to highlight data.
Claims 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al.: (US PGPUB 2023/0043676 A1) in view of Kupershmidt et al.: (US PGPUB 2020/0194121 A1) in view of Friedlander et al.: (US PGPUB 2008/0082356 A1) in view of Official Notice.
CLAIMS 42 and 43
The combination of Li/Kupershmidt/Friedlander discloses the limitations above relative to Claim 29. With respect to the following limitations:
wherein the data input means comprises a touch sensor on the display to detect a touch of the display where a state is displayed; (Li 0103).
Li discloses a touch screen device, but does not expressly disclose the following limitation:
wherein the data analyzer is configured to display data associated with the state where the display is touched.
However, Examiner takes Official Notice that displaying data associated with a touched display is old and well known. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the diagnostic system of Li/Kupershmidt/Friedlander so as to have common touch screen functionality, in accordance with the Official Notice taken, in order to provide touch access to data.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2020/0160995 A1 to Kenig et al. discloses a system and method for generating a list of tests to confirm a diagnosis.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
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/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 23 August, 2025