DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an
abstract idea without significantly more.
Step 1
Claims 1-18 are within the four statutory categories. However, as will be shown below, claims 1-18
are nonetheless unpatentable under 35 U.S.C. 101.
Claims 1, 17, and 18 are representative of the inventive concept and recite:
Claim 1
A method for creating a medical report, the medical report being indicative of a longitudinal examination of a patient, the method comprising
receiving an input longitudinal report data structure having longitudinal data elements, the longitudinal data elements being associated with annotation elements of a medical annotation database, the database being indicative of relationships between medical concepts;
receiving a set of one or more reference report data structures of the patient, wherein each reference report data structure has reference data elements associated with annotation elements of the medical annotation database;
determining, for each of the longitudinal data elements, whether said the longitudinal data element can be linked with a reference data element of at least one reference report data structure from the set of reference report data structures, based on the associated annotation elements and based on the medical annotation database;
and outputting, responsive to the determining, an interface element indicative of a pointer from the input longitudinal report data structure to said the reference report data structure having said the linked reference data element.
*Claims 17 and 18 recite similar limitations as claim 1
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the
highlighted components can practically be performed by the human mind (in this case, the process of
determining) or using pen and paper. Other than reciting generic computer components/functions such as “computer program product”, “non-volatile storage medium”, and “computer system” , “memory”, nothing in the claims precludes the highlighted portions from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the
limitation in the mind, but for the recitation of generic computer components/functions, then it falls
within “Mental Processes” grouping of abstract ideas. Additionally, the mere nominal recitation of a
generic computer does not take the claim limitation out of the mental process grouping. Thus, the claim
recites a mental process. Additionally, the recitation of generic computer components and functions such as receiving also covers behavioral or interactions between people (i.e. the computer), and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions), hence the claim falls under “Certain Methods of Organizing Human Activity”.
Dependent claims 2-16 recite additional subject matter which further narrows or defines the abstract idea embodied in the claims.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the claims
recite the following additional limitations:
Claim 1 recites: “A computer program product for creating a medical report, the medical report being indicative of a longitudinal examination of a patient, which is stored on a non-volatile storage medium and contains computer-readable instructions”, “computer system”, and “outputting, responsive to the determining, an interface element indicative of a pointer from the input longitudinal report data structure to said the reference report data structure having said the linked reference data element.”, and “pointer”.
In particular, the additional elements do no integrate the abstract idea into a practical application, other
than the abstract idea per se, because the additional elements amount to no more limitations which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations
are recited as being performed by a “A computer program product for creating a medical report, the medical report being indicative of a longitudinal examination of a patient, which is stored on a non-volatile storage medium and contains computer-readable instructions”, “computer system”, and “pointer”. These limitations are recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer.
• Add insignificant extra-solution activity (MPEP 2106.05(g)) to the abstract idea such as the
recitation of “receiving an input longitudinal report data structure having longitudinal data elements, the longitudinal data elements being associated with annotation elements of a medical annotation database, the database being indicative of relationships between medical concepts” and “outputting, responsive to the determining, an interface element indicative of a pointer from the input longitudinal report data structure to said the reference report data structure having said the linked reference data element.”
Dependent claims 6-9 recite “pointer”
In particular, the additional elements do no integrate the abstract idea into a practical application, other
than the abstract idea per se, because the additional elements amount to no more limitations which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations
are recited as being performed by a “pointer”. This limitation is recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer.
Dependent claims 2-5, and 10-16 do not include additional elements beyond those already recited in
Independent claims 1, 17, and 18 and dependent claims 6-9, and hence do not integrate the aforementioned abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, machine learning model, or any other technology. Their collective function merely provides conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
Claims 1, 17, and 18 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements: A system in claim 18; amount to no more than mere instructions to apply an exception to the abstract idea. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields as demonstrated by the recitation of:
Receiving, which refers to the process of obtaining or accepting information or data from a computer source (TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)) in a manner that would be well-understood, routine, and conventional.
Outputting, which refers to generating and presenting information from a computer or system (Para 0040, Torres(US 20180121849 A1) discloses: “The output device 260 may include one or more conventional mechanisms that output information to the user, including a display screen 262, a touch screen 252, a printer, one or more speakers 264, a headset, a vibrator, or a medium, such as a memory, or a magnetic or optical disk and a corresponding disk drive.”) in a manner that would be well-understood, routine, and conventional.
The claims do not include any additional elements beyond those already recited in independent claims
1, 17, and 18 and dependent claims 6-9. Therefore, they are not deemed to be significantly more
than the abstract idea because, as stated above, the limitations of the aforementioned dependent claims amount to no more than generally linking the abstract idea to a particular technological
environment or field of use, and/or do not recite and additional elements not already recited in
independent claims 1, 17, and 18 hence do not amount to “significantly more” than the abstract idea.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-7, 10, 11, and 14-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by
Min(US20220375072A1).
Claim 1
Min discloses:
A method for creating a medical report(Fig. 1, Min discloses a method for creating a patient-specific report), the medical report being indicative of a longitudinal examination of a patient(Figure 1, #126, Min discloses time-based analysis and disease tracking), the method comprising receiving an input longitudinal report data structure having longitudinal data elements(Fig. 1, Min discloses receiving medical image and/or data), the longitudinal data elements being associated with annotation elements(Para 0286 Min discloses an annotated medical image) of a medical annotation database(Para 0286 Min discloses an annotated medical image, which inherently assumes the existence of a medical annotation database), the database being indicative of relationships between medical concepts(Para 0286 Min discloses an annotated medical image, which inherently assumes the existence of a medical annotation database); receiving a set of one or more reference report data structures of the patient, wherein each reference report data structure has reference data elements associated with annotation elements(Figure 1, #126, Min discloses time-based analysis and disease tracking) of the medical annotation database(Para 0286 Min discloses an annotated medical image, which inherently assumes the existence of a medical annotation database); determining, for each of the longitudinal data elements, whether said the longitudinal data element can be linked with a reference data element of at least one reference report data structure from the set of reference report data structures, based on the associated annotation elements and based on the medical annotation database(Para 0150, Min discloses “if a medical image of the same subject is taken again at a later point in time, one or more processes described herein can be repeated and the analytical results thereof can be used for disease tracking…”); and outputting, responsive to the determining, an interface element indicative of a pointer from the input longitudinal report data structure to said the reference report data structure having said the linked reference data element(Para 0131, Min discloses: “if the system has access to one or more quantified parameters or classifications derived from previous scans or medical images of the subject, the system can be configured to compare the same with one or more quantified parameters or classifications derived from a current scan or medical image to determine the progression of disease and/or state of the subject…”).
Claim 2
Min discloses:
The method according to claim 1, wherein the longitudinal data elements are indicative of at least one or more of the following: a clinical question of the longitudinal examination; a medical finding of the longitudinal examination(Para 0131, Min discloses a medical scan/image); a report date of the longitudinal examination; and a diagnostic procedure of the longitudinal examination.
Claim 3
Min discloses:
The method according to claim 1, wherein the interface element is configured to at least partially display the reference data elements or the linked reference report data structure(Fig. 7B and 7C discloses a tracker tool which displays longitudinal patient data).
Claim 4
Min discloses:
The method according to claim 3, wherein the interface element is configured to indicate one or more of the following: a value or content of the reference data element(Para 0131, Min discloses quantified parameters derived from scans/medical images of a patient); a title of said the linked reference report data structure; a date of said the linked reference report data structure; an author indicated by said the linked reference report data structure; one or more multimedia files, such as images, associated with said the linked reference report data structure; a diagnostic procedure related to said the linked reference report data structure; and a therapeutic procedure related to said the linked reference report data structure.
Claim 5
Min discloses:
The method according to claim 1,further comprising: generating a graphical or textual indication(Para 0347, Min discloses the display of a red line when the tracker tool is activated), indicative of a temporal evolution of values or contents of the data elements, the temporal evolution comprising the longitudinal data element and the linked reference data element(Para 0221, Min discloses categorical classifications of disease progression based on the disease tracking tool).
Claim 6
Min discloses:
The method according to claim 1, further comprising: receiving user input in response to the output interface element(Para 0382, Min discloses user input to a user interface); and including the pointer in the longitudinal report data structure in response to the received user input(Para 0346 and 0347, Min discloses editing tool which can be used to change the report data structure in response to input).
Claim 7
Min discloses:
The method according to claim 1, wherein the pointer from the input longitudinal report data structure to said the reference report data structure is a pointer from the longitudinal data element to the linked reference data element(Para 0347, Min discloses the display of a red line when the tracker tool is activated).
Claim 10
Min discloses:
The method according to claim 1, wherein the interface element is output as a user interface element requiring confirmation by a user(Para 0133, Min discloses a physician reviewing/confirming/editing the GUI output).
Claim 11
Min discloses:
The method according to claim 1,wherein the determining is based on a clinical relationship between the associated annotation elements, and wherein the medical annotation database indicates whether the annotation element associated with the longitudinal data element and the annotation element associated with the reference data element are related to a same clinical question(Para 0131, Min discloses: “if the system has access to one or more quantified parameters or classifications derived from previous scans or medical images of the subject, the system can be configured to compare the same with one or more quantified parameters or classifications derived from a current scan or medical image to determine the progression of disease and/or state of the subject…”).
Claim 14
Min discloses:
The method according to claim 1,wherein the determining is further based on one or more of the following: the a presence of a regional relationship between the associated annotation elements, wherein the annotation element associated with the longitudinal data element and the annotation element associated with the reference data element are related if they refer to a same anatomical region(Para 0441, Min discloses a parameter database to determine parameters, such as vessel morphology, derived from raw images); the a presence of a modality relationship between the associated annotation elements, wherein the annotation element associated with the longitudinal data element and the annotation element associated with the reference data element are related if they refer to a same examination modality; and the a presence of a temporal relationship between the data elements, wherein the data elements are related if a time between the date of the reference examination indicated by the reference report data structure and the date of the longitudinal examination does not exceed a threshold duration, predetermined for the annotation element associated with the longitudinal data element and the annotation element associated with the reference data element.
Claim 15
Min discloses:
The method according to claim 1,wherein the medical annotation database comprises a medical ontology(Para 0143, Min discloses spatial mapping of plaques which inherently require a database comprising medical ontology) and/or a graph data structure.
Claim 16
Min discloses:
The method according to claim 1, wherein the set of one or more reference report data structures is received in response to a user- definable query(Para 0382, Min discloses user input to a user interface), the query comprising requirements for the reference report data structures.
Claim 17
Claim 17 recites similar limitations as claim 1. See claim 1 analysis.
Claim 18
Claim 18 recites similar limitations as claim 1. See claim 1 analysis.
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 8 is rejected under 35 U.S.C. 103 is being unpatentable over Min(US20220375072A1)
in view of Cooper(US20100106522A1).
Claim 8
Min does not explicitly disclose:
The method according to claim 7, further comprising: determining whether the data structures comprise further pointers, from the input longitudinal data element or from said the linked reference data element, to further linked data elements; and creating, responsive to said the determining of further pointers, a set of said the data elements which are linked by at least one of said the pointer or said the further pointers
Cooper discloses:
The method according to claim 7, further comprising: determining whether the data structures comprise further pointers, from the input longitudinal data element or from said the linked reference data element, to further linked data elements; and creating, responsive to said the determining of further pointers, a set of said the data elements which are linked by at least one of said the pointer or said the further pointers(Figure 4, Cooper discloses data structures comprising further pointers and linking).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for medical image analysis and disease tracking of Min to add determining whether the data structures comprise further pointers, from the input longitudinal data element or from said the linked reference data element, to further linked data elements; and creating, responsive to said the determining of further pointers, a set of said the data elements which are linked by at least one of said the pointer or said the further pointers, as taught by Cooper. One of ordinary skill would have been so motivated to provide a way to link all data elements related to longitudinal data tracking to determine the best course of action for a patient, but in this case for a system for organizing longitudinal multimodal records(Para 0004, Cooper discloses: “Clinicians and other users of data in health-care institutions are interested in obtaining information concerning different anatomical and pathologic concepts (e.g. tumor, edema region, mitral valve, etc.) to better assess the patient's condition. However, the heterogeneous sources of data lack any coherent organization of their content around the relevant medical concepts that are observable within them.”)
Claim 9 is rejected under 35 U.S.C. 103 is being unpatentable over Min(US20220375072A1)
in view of Ford(WO2020227291A1).
Claim 9
Min does not explicitly disclose:
The method according to claim 1, wherein the interface element is output in the longitudinal report data structure, in particular as a hyperlink indicative of the pointer.
Ford discloses:
The method according to claim 1, wherein the interface element is output in the longitudinal report data structure, in particular as a hyperlink indicative of the pointer(Para 0072, Ford discloses the generation of a pointer with a hyperlink application)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for medical image analysis and disease tracking of Min to add hyperlink indicative of the pointer, as taught by Ford. One of ordinary skill would have been so motivated to provide a way link medical data to a pointer to allow for better diagnosis and treatment for a patient, but in this case for a system which automates bots using a graphical pointer(Para 0005, Ford discloses: “In addition, bot designers have refined machine-learning algorithms to include artificial intelligence components that provide more accurate and faster completions of CAPTCHAs. As a result of the hots improvements, currently known CAPTCHAs may not be adequate.”).
Claims 12-13 is rejected under 35 U.S.C. 103 is being unpatentable over Min(US20220375072A1)
in view of Giovannini(US11928121B2).
Claim 12
Min does not explicitly disclose:
The method according to claim 1,wherein the determining is further based on a causality relationship between the associated annotation elements, and wherein the medical annotation database indicates whether the annotation element associated with the longitudinal data element is a potential consequence of the annotation element associated with the reference data element.
Giovannini discloses:
The method according to claim 1,wherein the determining is further based on a causality relationship between the associated annotation elements, and wherein the medical annotation database indicates whether the annotation element associated with the longitudinal data element is a potential consequence of the annotation element associated with the reference data element(Figure 1, #116, Giovannini discloses a chronology-aware graph data structure generator) .
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for medical image analysis and disease tracking of Min to add determining is further based on a causality relationship between the associated annotation elements, and wherein the medical annotation database indicates whether the annotation element associated with the longitudinal data element is a potential consequence of the annotation element associated with the reference data element, as taught by Giovannini. One of ordinary skill would have been so motivated to provide a way to better understand the causal relationships between data linked to data of interest to determine significance for the patient treatment, but in this case for a visual analytics pipeline for large datasets(Para 0005, Giovannini discloses: “Clinical decision rules have been developed for a number of medical disorders, and computer systems have been developed to help practitioners and patients apply these rules.”).
Claim 13
Min does not explicitly disclose:
The method according to claim 1,wherein the determining is further based on a statistical relationship between the associated annotation elements, and wherein the medical annotation database indicates whether the annotation element associated with the longitudinal data element is statistically correlated with the annotation element associated with the reference data element
Giovannini discloses:
The method according to claim 1,wherein the determining is further based on a statistical relationship between the associated annotation elements, and wherein the medical annotation database indicates whether the annotation element associated with the longitudinal data element is statistically correlated with the annotation element associated with the reference data element(Table 1, Giovannini discloses a statistical relationship between two datasets).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the system for medical image analysis and disease tracking of Min to add and wherein the medical annotation database indicates whether the annotation element associated with the longitudinal data element is statistically correlated with the annotation element associated with the reference data element, as taught by Giovannini. One of ordinary skill would have been so motivated to provide a way to better understand the causal relationships between data linked to data of interest to determine significance for the patient treatment, but in this case for a visual analytics pipeline for large datasets(Para 0005, Giovannini discloses: “Clinical decision rules have been developed for a number of medical disorders, and computer systems have been developed to help practitioners and patients apply these rules.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lyman(US20220215915A1) discloses a model assisted annotating system used for medical scans.
Conjeti(US20230282337A1) discloses a method for generating data of a radiological image data measurement.
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/S.G.P./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685