DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the election/restriction response filed on 11/19/25.
Claims 18-24 are withdrawn by Applicant.
Claims 1-17 are currently pending and have been examined.
Election/Restrictions
Applicant’s election without traverse of Invention I (Claims 1-17) in the reply filed on 11/19/25 is acknowledged.
Continuity/Priority Date
Status of this application as continuation of U.S. patent application Ser. No. 18/216,159 filed Jun. 29, 2023, which is a continuation of U.S. patent application Ser. No. 17/509,704 filed Oct. 25, 2021, which is a continuation of U.S. patent application Ser. No. 16/296,181 filed Mar. 7, 2019, which claims the benefit of U.S. provisional patent application No. 62/639,996 filed Mar. 7, 2018, is acknowledged. Accordingly, a priority date of Mar. 7, 2018 has been given to the instant application.
IDS
The information disclosure statement (IDS) submitted on 08/22/24 has been partially considered by the examiner. None of the eight non-patient literature references were considered.
The information disclosure statement filed 08/22/24 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 9 is objected to because of the following informalities: Line 17 recites “the application”. While this is understood to refer to the “web application” recited in lines 8 and 15 and does not cause true antecedent basis issues, Examiner recommends amending line 17 to recite “the web application” for improved clarity and coherence of the claim.
Claims 10-17 are objected to as they inherit the deficiencies of Claim 9.
Claim 17 is objected to because of the following informalities: The preamble of Claim 17 recites “The method of Claim 8 further comprising…”. However, Claim 8, which depends from Claim 1, is directed to a system, not a method. As independent claim 9 is directed to a method, Examiner is interpreting the preamble of Claim 17 to contain a typographical error of “8” rather than “9” and is interpreting Claim 17 as “The method of Claim 9 further comprising” for purposes of examination.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “display options in the smart phone and web application for the referrer to act on the recommendation by either accepting a recommendation, declining a recommendation, or deferring a decision or to first consult with a patient or another doctor or transfer responsibility to another doctor” (Emphasis Examiner), which renders the metes and bounds of the claim indefinite for the following reasons:
Claim 1 recites "the recommendation" in line 17. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this refers to “follow-up recommendations” in preamble (line 2) or a different recommendation. For purposes of examination, it is being interpreted as “the follow-up recommendation”.
Claim 1 further recites, in line 17, “accepting a recommendation, declining a recommendation…”. It is unclear if these recommendations are the same recommendation that the referrer acts on (line 17), and whether or not these are the same as the “follow-up recommendations” of the preamble (line 2). For purposes of examination, it is being interpreted as follow-up recommendations.
Dependent claims 2-8 are subsequently rejected as they inherit the deficiencies of parent claim 1.
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 1-17 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-8 are drawn to a system, and Claims 9-17 are drawn to a method, both of which are within the four statutory categories. Claims 1-17 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
assessing one or more instances of radiology information for the one or more radiology reports based on a preset configuration,
determining a referrer associated with the one or more radiology reports,
receiving the one or more instances of radiology information to determine whether a follow-up tracking is included in the one or more instances of radiology information,
opening a first loop based on the follow-up tracking included in the one or more instances of radiology information,
reporting to the referrer the one or more instances of radiology information associated with the one or more radiology reports and
providing options for the referrer to act on the recommendation by either accepting a recommendation, declining a recommendation, or deferring a decision or to first consult with a patient or another doctor or transfer responsibility to another doctor.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. The steps amount to accessing radiology reports to identify a referrer and determine if a follow-up tracking is included, initiating a workflow (e.g., “open a first loop”) based on the follow-up tracking information, providing a report to the referrer of radiology information, and providing options for the referrer to handle the recommendation (e.g., accept or decline a recommendation, defer a decision, etc.), all of which are personal behaviors that may be performed by healthcare providers.
Claim 9 recites implementing the steps of:
identifying and capturing a RAI in radiology reports
identifying and capturing a referrer in radiology reports by the SPARC application engine;
providing the reports to a user for follow-up tracking;
organizing of the reports into groups of those reports with RAI and those without RAI;
identifying test results and specific RAI for the reports with RAI and closing of loop for reports without RAI;
reporting to the referrer the one or more radiology reports and addendums organized into groups of those reports with RAI and those without RAI;
providing options for the referrer to either accept a recommendation, decline a recommendation, or defer a decision;
providing orders for follow-up testing to a radiologist; and
permitting the radiologist's office and the referrer's office to coordinate scheduling a follow-up exam and tracking a status of scheduling through exam completion.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. The steps amount to managing and tracking radiology reports to identify reports requiring recommended additional imaging, providing orders for a follow-up test, coordinating scheduling of a follow-up exam and tracking the status are all personal behaviors, which are all personal behaviors that may be performed by healthcare providers.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
a memory having computer readable instructions stored thereon (Claim 1)
an integration engine (Claim 1)
a secure database as the location from which one or more radiology reports are retrieved (Claim 1)
a processor configured to execute the computer-readable instructions from the memory as implementing the steps of assessing one or more instances of radiology information for the one or more radiology reports based on a preset configuration and determining a referrer associated with the one or more radiology reports (Claim 1)
a smart phone or web application configured to receive the one or more instances of radiology information as implementing the steps of determining whether a follow-up tracking is included in the one or more instances of radiology information, opening a first loop based on the follow-up tracking included in the one or more instances of radiology information, reporting to the referrer the one or more instances of radiology information associated with the one or more radiology reports and displaying options for the referrer to act on the recommendation by either accepting a recommendation, declining a recommendation, or deferring a decision or to first consult with a patient or another doctor or transfer responsibility to another doctor (Claim 1)
the SPARC application engine as implementing the steps of identifying and capturing a RAI in radiology reports and identifying and capturing a referrer in radiology reports (Claim 9)
the smart phone and web application as implementing the step of displaying of options for the referrer to either accept a recommendation, decline a recommendation, or defer a decision; providing (“transmitting”) orders for follow-up testing to a radiologist through the application; and providing (“securely transmitting”) the reports for follow-up tracking (Claim 9)
the (web) application as implementing the step of transmitting (providing) orders for follow-up testing to a radiologist (Claim 9)
The broad recitation of the above-listed general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding the memory, integration engine, secure database, processor, and SPARC application engine, these are all understood to be general purpose computing components functioning in their ordinary capacities to implement the steps of the abstract idea (e.g., see at least paras. [0041]-[0044]; “As used herein, computer and/or computing device may include, but are not limited to, personal computers (“PCs”) and minicomputers, whether desktop, laptop, or otherwise, mainframe computers, workstations, servers, personal digital assistants (“PDAs”), handheld computers, embedded computers, programmable logic devices, personal communicators, tablet computers, mobile devices, portable navigation aids, J2ME equipped devices, cellular telephones, smart phones, personal integrated communication or entertainment devices, and/or any other device capable of executing a set of instructions and processing an incoming data signal”; see para. [0047] regarding SPARC application engine).
Regarding the smart phone/web application, these are understood to be a general purpose smartphone functioning in its ordinary capacity and/or a web application accessed by a general purpose computing device functioning in its ordinary capacity per para. [0044] (cited in preceding paragraph) to implement the steps of the abstract idea.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Claim 1 also recites:
a secure database with one or more radiology reports fed through the integration engine;
retrieve one or more radiology reports from the secure database
Claim 9 also recites:
feeding one or more radiology reports and addendums through an integration engine into a secure database;
Recitation of “a secure database with one or more radiology reports fed through the integration engine” (Claim 1) and “feeding one or more radiology reports and addendums through an integration engine into a secure database” (Claim 9) only amount to insignificant extra-solution activity. As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the elements of “a secure database with one or more radiology reports fed through the integration engine” and “feeding one or more radiology reports and addendums through an integration engine into a secure database” are only nominally or tangentially related to the process of managing and tracking radiology referrals for recommendations for additional imaging, and accordingly constitutes insignificant extra-solution activity.
Recitation of “retrieve one or more radiology reports from the secure database” (Claim 1) only amounts to insignificant extra-solution activity in the form of mere data gathering.
These elements in Sections A and B above are therefore not sufficient to integrate the 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.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 9 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the elements of ”a secure database with one or more radiology reports fed through the integration engine” and “feeding one or more radiology reports and addendums through an integration engine into a secure database”, only amount to insignificant extra-solution activity; likewise, the element of “retrieve one or more radiology reports from the secure database” only amounts to insignificant extra-solution activity in the form of mere data gathering.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity, the elements of “a secure database with one or more radiology reports fed through the integration engine” and “feeding one or more radiology reports and addendums through an integration engine into a secure database” in Section B above constitute well-understood, routine and conventional activity. The elements of “a secure database with one or more radiology reports fed through the integration engine” and “feeding one or more radiology reports and addendums through an integration engine into a secure database” only amounts to storing/retrieving data in memory and/or receiving or transmitting data over a network, which have been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). The element of “retrieve one or more radiology reports from the secure database” only amounts to storing/retrieving data in memory, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Dependent Claims
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims:
Claim 2 recites limitations pertaining to reviewing the report data using rules driven processing to identify and capture key language elements contained in the report data, which is also certain methods of organizing human activity including managing personal behaviors, as these amount to data analysis steps that could be performed by a healthcare provider. Claim 2 also recites that “the processor is a scalable processor architecture (SPARC) application engine” as implementing the steps of the abstract idea, which only amounts to mere instructions to apply the abstract idea on a computer. See applicant’s specification, paras. [0041]-[0044], [0047]; see MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 3 recites limitations pertaining to identify, capture, assess, and report on any data element in the report, which is also certain methods of organizing human activity including managing personal behaviors, as these amount to data analysis steps that could be performed by a healthcare provider. Claim 3 also recites that “the processor is a scalable processor architecture (SPARC) application engine” as implementing the steps of the abstract idea, which only amounts to mere instructions to apply the abstract idea on a computer. See applicant’s specification, paras. [0041]-[0044], [0047]; see MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 4 recites limitations pertaining to wherein the data elements to be assessed and reported by the SPARC application engine comprise a time when actionable findings are communicated by a radiologist, who was notified of the finding, a presence of recommended additional imaging, and type of recommended additional imaging (RAI), which only narrows the scope of the abstract idea by specifying particular data elements to be assessed and reported. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 5 recites limitations pertaining to organizing the radiology reports into groups of reports with RAI and reports without RAI, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare provider could organize reports into groups with and without RAI. Claim 5 also recites that “the processor is further configured to execute the computer-readable instructions from the memory to” as implementing the steps of the abstract idea, which only amounts to mere instructions to apply the abstract idea on a computer. See applicant’s specification, paras. [0041]-[0044], [0047]; see MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 6 recites limitations pertaining to the referrer easily identifying a test result and a specific RAI for the group of reports with RAI, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare provider identify a test result and specific RAI for group of reports with RAI. Claim 6 also recites “the smart phone or web mobile application” as implementing the steps of the abstract idea, which only amounts to mere instructions to apply the abstract idea on a computer. See applicant’s specification, paras. [0041]-[0044], [0047]; see MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 7 recites limitations pertaining to managing completed radiology tests, managing orders for additional radiology tests, tracking an opinion of at least one doctor regarding results of the radiology test, and continuously updating at least one patient medical record, which is also certain methods of organizing human activity including managing personal behaviors, as all of these steps are behaviors that could be performed by a healthcare provider, e.g., managing orders for additional radiology tests. Claim 7 also recites “the at least one processor is further configured to execute the computer-readable instructions” as implementing the steps of the abstract idea, which only amounts to mere instructions to apply the abstract idea on a computer. See applicant’s specification, paras. [0041]-[0044], [0047]; see MPEP 2106.05(f). Regarding recitation of “EMR”, this only amounts to mere instructions to implement a medical record electronically, e.g., on a computer, and therefore only amounts to mere instructions to apply the abstract idea. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 8 recites wherein the radiology reports and addendums are fed through the integration engine into the secure database via an HL7 feed which amounts to insignificant extra-solution activity. As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the function of feeding radiology reports and addendums into a secure database is only nominally or tangentially related to the process of managing and tracking recommended additional imaging for radiology reports, and accordingly constitutes insignificant extra-solution activity. In addition to amounting to insignificant extra-solution activity, the above limitations also constitute well-understood, routine and conventional activity in the form of storing/retrieving information in memory and/or transmitting data over a network (e.g., “feeding through…”). These types of activities have been recognized by the courts as well-understood, routine and conventional activity when claimed as insignificant extra-solution activity. See MPEP 2106.05(d). These limitations are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 10 recites limitations pertaining to wherein reasons for declining the recommendation includes lack of clinical correlation, end of life, other patient decision, or referral to a specialist, which narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 11 recites limitations pertaining to wherein the referrer can be a radiologist, a primary care physician, or another specialist, which narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 12 recites limitations pertaining to wherein continuously tracks a referrer's decisions and a status of each patient, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare provider could continuously track decisions and patient status. Claim 12 recites “the application” as a means of implementing the abstract idea. As discussed above with respect to independent claims, recitation of “the application” only amounts to mere instructions to apply the abstract idea on a general purpose computing device. MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 13 recites wherein the application allows for a secure call, text, or email with a consulting doctor, which only amounts to mere instructions to apply the abstract idea, e.g., communicating with a consulting doctor, via electronic systems (the application / secure call, text or email). MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 14 recites limitations pertaining to, wherein all deferred decisions are tracked, enabling the referrer to periodically review them and, as appropriate, either further defer, accept, or decline the recommendation, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare providers could track statuses of deferred decisions, review them and provide a further decision to defer, accept or decline. Claim 14 recites “the application” as a means of implementing the abstract idea. As discussed above with respect to independent claims, recitation of “the application” only amounts to mere instructions to apply the abstract idea on a general purpose computing device. MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 15 recites limitations pertaining to the referrer and radiologist tracking a status of both existing test results and RAI, which is also certain methods of organizing human activity including managing personal behaviors, as a healthcare providers could track statuses of existing test results and RAI. Claim 15 recites “the application” as a means of implementing the abstract idea. As discussed above with respect to independent claims, recitation of “the application” only amounts to mere instructions to apply the abstract idea. MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 16 recites limitations pertaining to wherein if an exam result includes a new recommendation, a new loop opens upon introduction of the new recommendation in the exam result, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could open a new loop (broadest reasonable interpretation of “open a new loop” is understood to be initiating a new workflow) when an exam result includes a new recommendation. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 17 recites limitations pertaining to continuously updating at least one medical record, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider could continuously update a patient’s medical record with new information as it becomes available. Regarding recitation of “EMR”, this only amounts to mere instructions to implement a medical record electronically, e.g., on a computer, and therefore only amounts to mere instructions to apply the abstract idea. MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 1 or claim 9 respectively. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea
Dependent claims 2-8, 10-17 recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of Claims 1 and 9 above. As discussed above with respect to Claims 1 and 9 and integration of the abstract idea into a practical application, recitation of these additional elements only amounts to invoking computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Dependent claims 2-8, 10-17, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1-17 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
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.
Claims 1, 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Halsted (US Publication 20070067185A1) in view of Kulon (US Publication 20170109473A1).
Regarding Claim 1, Halsted discloses:
a memory having computer readable instructions stored thereon ([0052] teaching on the user of a server (a computer), databases, and a networked computer as part of the exemplary system, see Fig. 1; Examiner interprets a computer to necessarily include a memory storing instructions for execution);
an integration engine ([0052] teaches on a “translation interface” such as an HL7 interface, which is interpreted as being synonymous with “integration engine” as para. [0052] discloses that the translation interface is used “to integrate databases from separate health systems by translating and standardizing different terms used by each database”);
a secure database with one or more radiology reports fed through the integration engine ([0052] teaches on various databases including a “radiology database” and a translation interface (“integration engine”) for integrating databases from separate health systems; the system pulls information from various discrete databases (interpreted as including the radiology database; see Figs. 1-2) and pushing the information to a system user; “integrating” databases is interpreted as “feeding” the information in the databases through the integration engine; where [0049], [0054] and [0060] teach on radiology reports; [0051] teaches on data encryption and firewall security measures to protect all information/communications managed by the system – interpreted as teaching “secure” database);
a processor configured to execute the computer-readable instructions from the memory to retrieve one or more radiology reports from the secure database ([0052] teaches on the system pulling information from various discrete databases (interpreted as including the radiology database; see Figs. 1-2) and pushing the information to a system user; where [0049], [0054] and [0060] teach on radiology reports; [0049] teaches on using a “networked computer system” for accessing radiology reports; Examiner interprets a “networked computer system” to necessarily include a processor for executing instructions), assess one or more instances of radiology information for the one or more radiology reports based on a preset configuration ([0052] teaches on retrieving a radiology report from a database “according to the user’s defined subscription or tracer” – interpreted as “preset configuration”; see also paras. [0058]-[0061], teaching on using the computer system to select a patients and/or attribute to track; the user may enter a medical record number, patient name, and/or physician name; search results are returned; a physician may name a tracer for later reference or choose from a list of pre-set preferences from drop-down menu, including pre-saved macros established by the user – also interpreted as “preset configuration”) and determine a referrer associated with the one or more radiology reports ([0063] teaches on a radiologist recommending a follow-up to evaluate a worrisome finding; if the exam is not performed, the referring radiologist is notified which is interpreted as identifying a referrer (the radiologist) as the system knows which provider to notify); and
a smart phone or web application configured to receive the one or more instances of radiology information to determine whether a follow-up tracking is included in the one or more instances of radiology information, open a first loop based on the follow-up tracking included in the one or more instances of radiology information ([0052] teaches on the system communicating with physicians and professionals utilizing the system via “networked computer”, “a handheld device”, or a “cellular device”; see Fig. 1; paras. [0060]-[0061] teach on follow-up tracking being configured; the user selects which reports/categories to track and/or ensure follow-up; the user may select categories/sub-categories to track, e.g., the radiology category includes subcategories CT and MRI; the user may select a time window for tracking to be performed; the user clicks “Save” button and the tracer will automatically push notification to the user when events are detected, in real-time, that meet the constraints of the tracer; Examiner interprets the user selecting fields and hitting “save” as reading on “open a first loop based on the follow-up tracking…” as the system subsequently begins to push notifications of events meeting the constraints to the user after the tracer is activated);
report to the referrer the one or more instances of radiology information associated with the one or more radiology reports ([0049] teaches on a user selecting a particular item to monitor, e.g., radiology reports; the system automatically monitors these portions of the patient's EMR and when a new event occurs in an area the user has marked as “track” (e.g., new radiology report) the system automatically generates a notification and sends it to the user to notify them of the event; [0063] teaches on an example of a radiologist (“referrer”) recommending a follow-up exam to evaluate a worrisome finding and using the system to monitor if the exam is performed in the recommended timeframe; if the exam is not so performed, the system notifies the radiologist)
Halsted does not teach the following, but Kulon, which is directed to a system for identifying patients who did not obtain a recommended relevant therapeutic intervention or diagnostic test, such as radiological imaging, teaches:
display options in the smart phone and web application for the referrer to act on the recommendation by either accepting a recommendation, declining a recommendation, or deferring a decision or to first consult with a patient or another doctor or transfer responsibility to another doctor ([0040] teaches on displaying recommendations; [0041] teaches on allowing a human operator to indicate and instruct the system to “postpone further action until a specific date or for specific duration” – interpreted as “deferring”; [0041] further teaches on a note may state “CT recommended MRI. Patient has a contraindication to MRI. Will follow-up with blood test instead” – interpreted as “declining a recommendation” (where the recommendation is an MRI)); [0042] teach on receiving a response from the clinician such as “test will be performed”, interpreted as “accepting a recommendation”; Fig. 1/para. [0038] are interpreted as reading on the broadest reasonable interpretation of a web application; para. [0038] teaches on a human operator interacting with the system via a server computer that communicates with a separate web-browser or client application).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Halsted with these teachings of Kulon, to provide options for the referrer to accept, decline or defer a recommendation/decision, as taught by Kulon, with the motivation of enabling a human operator to indicate a disposition of a detected recommendation (Kulon [0038]).
Regarding Claim 6, Halsted/Kulon teach the limitations of Claim 1. Halsted further discloses: wherein the smart phone or web mobile application provides functionality to allow the referrer to easily identify a test result and a specific RAI for the group of reports with RAI ([0048] teaches on a reporting physician to send an electronic report to the ordering physician to include a recommendation for further testing, examinations and/or procedures in the form of links; the ordering physician need only click on the link/icon associated with a particular test, exam or procedure to order that test, exam or procedure or begin the ordering process).
Regarding Claim 7, Halsted/Kulon teach the limitations of Claim 6. Halsted further discloses wherein the at least one processor is further configured to execute the computer-readable instructions to manage completed radiology tests, manage orders for additional radiology tests, track an opinion of at least one doctor regarding results of the radiology test, and continuously update at least one patient EMR (Fig. 1 and [0052] discloses databases, including radiology database, interpreted as storing completed radiology tests; [0048] teaches on an “electronic reporting method” for recommendations for further testing, examinations and/or procedures (interpreted as “managing orders for additional radiology testing”); [0036]-[0038] and [0050] teach on using natural language processing to identify and track a radiologist’s diagnosis based on a radiology test (interpreted as “tracking an opinion of at least one doctor regarding results…”); tracking all reports for discrepancies is interpreted as reading on “managing completed radiology tests”; [0031] teaches on using an EMR system for execute of the invention, as seen in [0054], for tracking both future test results and past test results (e.g., information present in a patient’s EMR); [0049] explicitly teaches on monitoring a patient’s EMR for new events, disclosing new events as being, for example, radiology reports (e.g., continuously updating EMR)).
Regarding Claim 8, Halsted/Kulon teach the limitations of Claim 1. Halsted further discloses wherein the radiology reports and addendums are fed through the integration engine into the secure database via an HL7 feed ([0052] teaches on the translation interface (synonymous with “integration engine” as discussed above with respect to parent Claim 1) as an HL7 interface for integrating databases).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over
Halsted (US Publication 20070067185A1) in view of Kulon (US Publication 20170109473A1) as applied to Claim 1 above, and further in view of Rosenfeld et al. (US Publication 20050159987A1).
Regarding Claim 2, Halsted/Kulon teach the limitations of Claim 1. Halsted further discloses wherein the processor reviews the report data using rules driven processing to identify and capture key language elements contained in the report data ([0036]-[0042] teach on using natural language processing in conjunction with expert rules to process radiology reports, e.g., extracting a diagnosis from a report and comparing it to a list of conditions; per [0052] teaching on a server and networked computer for accessing information, which both necessarily include a processor).
Halsted/Kulon do not disclose a scalable processor architecture (SPARC) application engine. Rosenfeld, which is directed to methods of standardizing care in a hospital environment, teaches: a scalable processor architecture (SPARC) application engine (Fig. 10, para. [0205] teach on using a SPARC engine).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Halsted/Kulon with these teachings of Rosenfeld, to incorporate a SPARC engine to perform the task of reviewing report data using rules driven processing to identify and capture key language elements contained in the report data, as SPARC components are commonly used in healthcare settings for handling of patient information (Rosenfeld [0205]).
Regarding Claim 3, Halsted/Kulon/Rosenfeld teach the limitations of Claim 2. Halsted further discloses: wherein the SPARC application engine is programmed to identify, capture, assess, and report on any data element in the report ([0036]-[0042] teach on using natural language processing with expert rules to report on a number of different elements; for example, receiving a radiologist’s initial diagnosis (“capture”); comparing a radiologist’s report with final pathologic diagnosis (“assess”) and alert the radiologist if there were a significant discrepancy (“report on any data element”); extracting term ‘teratoma’ (identifying a data element); as well as in [0058] and [0060] where patients, reports, categories, and/or other attributes can be tracked (Examiner submits that the SPARC application engine is taught by Rosenfeld as discussed above in parent Claim 2).
Regarding Claim 4, Halstead/Kulon/Rosenfeld teach the limitations of Claim 3. Halsted further discloses wherein the data elements to be assessed and reported by the SPARC application engine comprise a time when actionable findings are communicated by a radiologist, who was notified of the finding, a presence of recommended additional imaging, and type of recommended additional imaging (RAI) ([0045] teaches on an example of a patient with a brain tumor being due for an MRI scan to reassess the tumor in 3 months (presence and type of RAI – an order for a brain MRI exists and is a specific type of imaging); the radiologist scheduling office ordering an MRI to reassess a brain tumor after 3 months is interpreted as “actionable findings communicated by a radiologist” as the presence of a brain tumor requires additional imaging at 3 months; the patient’s authorized family member is interpreted as “who was notified of the finding” as they are alerted to follow up if the recommended additional imaging at 3 months is not performed (SPARC engine is taught by Rosenfeld as shown above with respect to Claim 2).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Halsted (US Publication 20070067185A1) in view of Kulon (US Publication 20170109473A1) as applied to Claim 1 above, and further in view of Xu et al. (US Publication 20170017930A1).
Regarding Claim 5, Halsted/Kulon teach the limitations of Claim 1 but do not teach the following. Xu, which is directed to system and method for scheduling healthcare follow-up appointments based on written recommendations, teaches wherein the processor is further configured to execute the computer-readable instructions from the memory to organize the radiology reports into groups of reports with RAI and reports without RAI (Abstract teaches on determining whether an appointment corresponding to a follow-up recommendation has been scheduled; [0009] teaches on a report being structured to include a section for “recommendations”; [0010] discloses identifying reports with RAI, thereby distinguishing between reports with and without RAI; [0011] teaches on the system searching a database and determining that a patient has not been scheduled for a follow-up and alerting a user that a follow-up should be scheduled; Fig. 3/para. [0012] teach on determining whether a follow-up study has been recommended (determining whether or not RAI is present). Halsted discloses computer-implementation, as discussed in claim 1.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to further modify the combined teachings of Halsted/Kulon to organize the radiology reports into groups of reports with RAI and reports without RAI as taught by Xu, with the motivation of determining whether a follow-up has been recommended for a patient (Xu, Abstract).
Claims 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over
Halsted (US Publication 20070067185A1) in view of Rosenfeld et al. (US Publication
20050159987A1), further in view of Xu et al. (US Publication 20170017930A1), and
further in view of Kulon (US Publication 20170109473A1).
Regarding Claim 9, Halsted discloses:
feeding one or more radiology reports and addendums through an integration engine into a secure database ([0052] teaches on a “translation interface” such as an HL7 interface, which is interpreted as being synonymous with “integration engine” as para. [0052] discloses that the translation interface is used “to integrate databases from separate health systems by translating and standardizing different terms used by each database”; [0052]/[0054] disclose clinical notes database/clinical notes (e.g., addendums); [0051] teaches on data encryption and firewall security measures);
identifying and capturing a RAI in radiology reports ([0048], [0072] teach on RAI in the radiology report) ;
identifying and capturing a referrer in radiology reports([0049] teaches on a user selecting a particular item to monitor, e.g., radiology reports; the system automatically monitors these portions of the patient's EMR and when a new event occurs in an area the user has marked as “track” (e.g., new radiology report) the system automatically generates a notification and sends it to the user to notify them of the event; [0063] teaches on an example of a radiologist (“referrer”) recommending a follow-up exam to evaluate a worrisome finding and using the system to monitor if the exam is performed in the recommended timeframe; if the exam is not so performed, the system notifies the radiologist, which is interpreted as identifying a referrer (the radiologist) as the system knows which provider to notify);
securely transmitting the reports to a smart phone and web application for follow-up tracking ([0051], [0055], [0071] teach on security measures, e.g., [0051] teaches on encryption/firewall security to protect all information/communication managed by the system; [0052] teaches on the system communicating with physicians and professionals utilizing the system via “networked computer”, “a handheld device”, or a “cellular device”, e.g., a web application; see Fig. 1; paras. [0060]-[0061] teach on follow-up tracking being configured; the user selects which reports/categories to track and/or ensure follow-up; the user may select categories/sub-categories to track, e.g., the radiology category includes subcategories CT and MRI; the user may select a time window for tracking to be performed; the user clicks “Save” button and the tracer will automatically push notification to the user when events are detected, in real-time, that meet the constraints of the tracer – interpreted as securely transmitting reports to a user for follow-up tracking)
identifying test results and specific RAI for the reports with RAI and closing of loop for reports without RAI ([0048] teaches on a reporting physician to send an electronic report to the ordering physician to include a recommendation for further testing, examinations and/or procedures in the form of links; the ordering physician need only click on the link/icon associated with a particular test, exam or procedure to order that test, exam or procedure or begin the ordering process; see also [0072]; an ordering physician can select to receive the report when the ordered exam has been completed and the ordering physician will receive the report, which is interpreted as “closing of loop for reports without RAI” as the exam has already been completed and additional imaging is no longer required);
transmitting of orders for follow-up testing to a radiologist through the application ([0048] teaches on a reporting physician providing recommendations for further testing, examinations and/or procedures to an ordering physician in which the test can be ordered by clicking a link/icon – interpreted as being transmitted through the application; per [0002], [0063], “physician” is understood to encompass a radiologist); and
permitting the radiologist's office and the referrer's office to coordinate scheduling a follow-up exam and tracking a status of scheduling through exam completion ([0048] and [0072] teaching on scheduling; [0064] teaches on if an exam is not completed, the system notifies the scheduling office so that another test or exam can be scheduled; [0049], [0053], [0062], [0063] teaches on an example of a radiologist being notified when a patients does not have an recommended follow-up exam performed; [0065]-[0066] teach on being notified upon an event occurring (e.g., tracking status to completion).
Halsted does not disclose, but Rosenfeld, which is directed to methods of standardizing care in a hospital environment, teaches: a scalable processor architecture (SPARC) application engine (Fig. 10, para. [0205] teach on using a SPARC engine).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Halsted with these teachings of Rosenfeld, to incorporate a SPARC engine to perform the task of reviewing report data using rules driven processing to identify and capture key language elements contained in the report data, as SPARC components are commonly used in healthcare settings for handling of patient information (Rosenfeld [0205]).
Halsted/Rosenfeld do not teach the following, but Xu, which is directed to a system and method for scheduling healthcare follow-up appointments based on written recommendations, teaches organizing of the reports into groups of those reports with RAI and those without RAI (Abstract teaches on determining whether an appointment corresponding to a follow-up recommendation has been scheduled; [0009] teaches on a report being structured to include a section for “recommendations”; [0010] discloses identifying reports with RAI, thereby distinguishing between reports with and without RAI; [0011] teaches on the system searching a database and determining that a patient has not been scheduled for a follow-up and alerting a user that a follow-up should be scheduled; Fig. 3/para. [0012] teach on determining whether a follow-up study has been recommended (determining whether or not RAI is present). Halsted discloses computer-implementation, as discussed in claim 1);
reporting to the referrer the one or more radiology reports and addendums organized into groups of those reports with RAI and those without RAI (As above, Xu paras. [0009]-[0012] teach on identifying reports with RAI, thereby distinguishing between reports with and without RAI; the claim only requires one report (i.e. "one or more radiology reports"), so determining if the report does or does not contain RAI satisfies the broadest reasonable interpretation of the claim limitation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combined teachings of Halsted/Rosenfeld with these teachings of Xu, to organize the radiology reports into groups of reports with RAI and reports without RAI and report to the referrer the radiology report organized into groups of those with/without RAI, with the motivation of determining whether a follow-up has been recommended for a patient (Xu, Abstract).
Halsted/Rosenfeld/Xu do not teach the following, but Kulon, which is directed to a system for identifying patients who did not obtain a recommended relevant therapeutic intervention or diagnostic test, such as radiological imaging, teaches:
displaying of options in the smart phone and web application for the referrer to either accept a recommendation, decline a recommendation, or defer a decision ([0040] teaches on displaying recommendations; [0041] teaches on allowing a human operator to indicate and instruct the system to “postpone further action until a specific date or for specific duration” – interpreted as “deferring”; [0041] further teaches on a note may state “CT recommended MRI. Patient has a contraindication to MRI. Will follow-up with blood test instead” – interpreted as “declining a recommendation” (MRI)); [0042] teach on receiving a response from the clinician such as “test will be performed”, interpreted as “accepting a recommendation”; Fig. 1/para. [0038] are interpreted as reading on the broadest reasonable interpretation of a web application; para. [0038] teaches on a human operator interacting with the system via a server computer that communicates with a separate web-browser or client application).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the combined teachings of Halsted/Rosenfeld/Xu with these teachings of Kulon, to provide options for the referrer to accept, decline or defer a recommendation/decision, as taught by Kulon, with the motivation of enabling a human operator to indicate a disposition of a detected recommendation (Kulon [0038]).
Regarding Claim 10, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted does not disclose, but Kulon further teaches: wherein reasons for declining the recommendation includes lack of clinical correlation, end of life, other patient decision, or referral to a specialist ([0042] teaches on “patient declined the test”, interpreted as “other patient decision”).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to further modify the combined teachings of Halsted/Rosenfeld/Xu/Kulon with these teachings of Kulon to include a reason for declining the recommendation of other patient decision with the motivation of enabling a patient to communicate their response (Kulon [0042]).
Regarding Claim 11, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted further discloses wherein the referrer can be a radiologist, a primary care physician, or another specialist ([0008] teaches on a primary or treating physician ordering a test, examination and/or procedure to be performed by a specialist (e.g., a radiologist) – in this situation the referrer is a primary care physician; [0063] teaches on a radiologist ordering additional examination in which case the radiologist is the referrer).
Regarding Claim 12, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted further discloses wherein the application continuously tracks a referrer's decisions and a status of each patient ([0051] discloses an audit database for automatically logging all notification requests, communications and requisitions; also see [0067], “The system of the present invention is also configured to automatically log each and every tracking and watching scenario that is set up”; [0053] emphasizes the automated nature of the invention, e.g., automatically pushing a notification when a condition is fulfilled; see also [0058]-[0061] where various patients, reports, categories, and/or attributes are tracked; once tracers are set up, a real-time notification is pushed to the user when a constraint is met; see also [0048], [0072] physician decisions on follow-up ordering).
Regarding 13, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted further discloses wherein the application allows for a secure call, text, or email with a consulting doctor ([0032] teaches on healthcare providers being able to track future developments and outcomes of particular cases, e.g., a radiologist may want to her whether her initial interpretation of a mass was accurate; an ER physician may wish to find out how a patient he saw and admitted to the intensive care unit did after leaving the ER; [0033] teaches on physicians in a same department, practice group or discussion group being able to track progress, e.g., the head of radiology dept may want to know whether a report prepared by an associated was accurate; an entire group of physicians treating a single patient may wish to be informed of test results, labs or exams procured by each other; [0070] teaches on fostering efficient collaborations within a practice group by seeking second opinion – seeking a “second opinion” within a “practice group” is interpreted as taking place with a “consulting doctor”; per [0051], data encryption and firewall security is used to protect all information and communications managed by the system – therefore the communications of paras. [0032], [0033], [0070] are interpreted as being ‘secure’).
Regarding Claim 14, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted does not disclose, but Kulon further teaches: wherein all deferred decisions are tracked inside the application, enabling the referrer to periodically review them and, as appropriate, either further defer, accept, or decline the recommendation ([0040] teaches on displaying recommendations; [0041] teaches on allowing a human operator to indicate and instruct the system to “postpone further action until a specific date or for specific duration” – interpreted as “deferring”; [0041] further teaches on a note may state “CT recommended MRI. Patient has a contraindication to MRI. Will follow-up with blood test instead” – interpreted as “declining a recommendation” (MRI)); [0042] teach on receiving a response from the clinician such as “test will be performed”, interpreted as “accepting a recommendation”; Fig. 1/para. [0038] are interpreted as reading on the broadest reasonable interpretation of a web application; para. [0038] teaches on a human operator interacting with the system via a server computer that communicates with a separate web-browser or client application).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Halsted with these teachings of Kulon, to provide options for the referrer to accept, decline or defer a recommendation/decision, as taught by Kulon, with the motivation of enabling a human operator to indicate a disposition of a detected recommendation (Kulon [0038]).
Regarding Claim 15, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted further discloses wherein the application permits the referrer and radiologist to track a status of both existing test results and RAI ([0058]-[0061] disclose patients, reports, categories, and/or other attributes can be tracked; [0063] specifically discloses RAI being tracked by a radiologist; [0065]-[0066] discloses multiple people being notified by the tracker, including multiple physicians, also see [0035]).
Regarding Claim 16, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted further discloses, wherein if an exam result includes a new recommendation, a new loop opens upon introduction of the new recommendation in the exam result ([0049] teaches on monitoring a patient’s EMR; when a new event occurs, the system alerts the user that a new event has occurred and provides at least a portion of the report content from that new event – interpreted as [0058] and [0060] disclose patients, reports, categories, and/or other attributes can be tracked, and [0048], [0072] disclose follow-up ordering when a recommendation is received with the exam results).
Regarding Claim 17, Halsted/Rosenfeld/Xu/Kulon teach the limitations of Claim 9. Halsted further discloses further comprising continuously updating at least one EMR ([0031] discloses utilizing an EMR system for execution of the invention, which can be seen in [0054], for example, disclosing tracking both future test results and past test results; the system can display “all prior results/records or filtered results/records from hospital information systems” (as would be present in a patient's EMR); [0049] explicitly discloses monitoring a patient's EMR for new events, disclosing new events as, for example, radiology reports (i.e. continuously updating EMR if new events such as radiology report can be detected)).
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record and is noted on the enclosed PTO-892:
US Publication 20140288970A1, teaching on identifying relevant imaging examination recommendations for a patient from prior medical reports of the patient to facilitate determining a follow up imaging examination(s) for the patient
US Publication 20190272919A1, teaching on a system for facilitating proactive follow-up of clinical findings
US Publication 20080123917A1, teaching on an imaging study completion processing system which tracks current status and completion of imaging studies and reports
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682