DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Subject Matter Free of Prior Art
The following is a statement of reasons for the subject matter free of prior art:
Claim 1 distinguishes over the prior art for the following reasons.
Claim 1 recites:
“…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…”
The underlined recited limitation indicates the reason for subject matter free of prior art.
The closest available prior art of record as follows:
• Min(US20220375072A1) discloses a system for medical image analysis, but does not fairly disclose the determining step configuration for the claimed invention.
• Giovannini(US11928121B2) discloses scalable visual analytics pipeline for large datasets, but does not fairly disclose the determining step configuration for the claimed invention.
• Cooper(US20100106522A1) discloses a system for organizing and displaying longitudinal multimodal medical records, but does not fairly disclose the determining step configuration for the claimed invention.
Based on the evidence presented above, none of the closest available prior art of record fairly
discloses or suggests the claimed invention. For this reason, claim 1 and dependent claims 2-18 (via dependency) would be found to be subject matter free of prior art.
Response to Arguments
35 U.S.C. 101
(Pages 8-9) Regarding the assertion that the claims are not directed to a mental process.
Applicant's arguments filed have been fully considered but they are not persuasive. The specifics on which the claims call for on page 8 of the arguments are not recited in the claim. The claims are interpreted under 101 as written. The specification cannot be read into the claims for analysis purposes. “Annotation database”, “structured data”, etc, as recited are not recited specifically (without definition). As a result, the processes outlined in the claims can be performed in the human mind.
(Page 9) Regarding the assertion that the claims recite significantly more than the alleged abstract idea.
Applicant's arguments filed have been fully considered but they are not persuasive. 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. An alternate reference for outputting includes the following: Para 0042, Banerjee(US 20180365212 A1) discloses: “However, instead of simply outputting this response, as in conventional systems, the disclosed systems and methods automatically transform the initial chatbot response to produce domain-specific response that mimics a native style unique to the particular domain from which the query was entered. “)
(Pages 10-12) Regarding the assertion that claim 1 of example 42 is analogous to the presented claims.
Applicant's arguments filed have been fully considered but they are not persuasive. In claim 1 of example 42, if the computing elements were to be removed from the claims, a human is unable to perform the steps. In contrast, with the presented claims of this application, a human is able to perform the steps that were designated for the computing elements recited in the claim.
35 U.S.C. 102/ 35 U.S.C. 103
(Page 15) Regarding the assertion that Min does not teach the determining step in claim 1.
Applicant’s arguments, with respect to the determining step in claim 1 has been fully considered and are persuasive. The 102 rejection of claim 1 has been withdrawn.
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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHERYL GOPAL PATEL whose telephone number is (703)756-1990. The examiner can normally be reached Monday - Friday 5:30am to 2:30pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.G.P./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
Prosecution Insights