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
The action is in reply to the response filed 2026 March 18.
Claims 1-30 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 01/08/2026 and 03/09/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Notice to Applicant
In the claims, applicant uses abbreviations such as ML and AI which the examiner interprets as machine learning and artificial intelligence respectively in light of [0271] of the specification.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/518,241 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For claims 1, 11, and 21 the prior-filed application does not provide support for “receiving data signals from one or more first vendor devices;
receiving data signals from one or more second vendor devices; and
normalizing the data signals from the one or more first vendor devices and
the one or more second vendor devices to generate a plurality of homogenized
signals that can work together”, “generating an urgent care report for the one or more patients”, and “the urgent care report includes one or more of: a summary of the urgent care event of the one or more patients.” Examiner cannot find disclosure of receiving data signals from first and second vendor devices and normalizing the data signals, generating an urgent care report for the one or more patients and the urgent care report including a summary in the prior filed application. For claims 5, 15, and 25 the prior-filed application does not provide support for “utilizing massive data sets processed by ML to process the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event.” Examiner cannot find disclosure of utilizing massive data sets processed by ML in the prior filed application. For claims 6, 16, and 26 the prior-filed application does not provide support for “utilizing a generative AI model to generate the urgent care report for the one or more patients.” Examiner cannot find disclosure of utilizing a generative AI model to generate the urgent care report in the prior filed application. For claims 7, 17, and 27 the prior-filed applications does not provide support for “utilizing prompt engineering and the generative AI model to generate the rounding list that prioritizes the plurality of patients.” Examiner cannot find disclosure of utilizing prompt engineering and the generative AI model to generate the rounding list that prioritizes the plurality of patients in the prior filed application. For claims 10, 20, and 30 the prior-filed applications do not provide support for “wherein the medical device includes one or more sub-medical devices.” Examiner cannot find disclosure of one or more sub-medical devices in the prior filed application. Accordingly, claims 1-20 are not entitled to the benefit of the prior application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of 18/798,710 in view of Welch et al. (US20070180140A1). Although the claims at issue are not identical, they are not patentably distinct from each other because recite substantially similar limitations.
This is a provisional nonstatutory double patenting rejection.
The table/chart below exhibits the similarity* between the independent claims where claims 1, 11, and 21 of the current application is a narrower variation of the claims of the reference application.
* Similarities highlighted in BOLD
App# 18/798,716
18/798,710
Claims 1, 11, and 21:
A computer-implemented method, executed on a computing device, comprising:
monitoring a plurality of data signals associated with a plurality of patients within a medical environment, including:
receiving data signals from one or more first vendor devices;
receiving data signals from one or more second vendor devices; and
normalizing the data signals from the one or more first vendor devices and
the one or more second vendor devices to generate a plurality of homogenized
signals that can work together;
processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event; and
if such an urgent care event is occurring, generating an urgent care report for the one or more patients, wherein the urgent care report includes one or more of:
a summary of the urgent care event of the one or more patients,
a justification as to why this is an urgent care event for the one or more patients, and
a recommendation for addressing the urgent care event of the one or more patients.
.
Claims 1, 11, and 21:
A computer-implemented method, executed on a computing device, comprising:
monitoring a plurality of data signals associated with a plurality of patients within a medical environment;
processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event; and
if such an urgent care event is occurring, notifying an on-call care member so that the urgent care event can be addressed
.
The difference between the present application and 18/798,710 is that the present application discloses receiving data signals from one or more first vendor devices;
receiving data signals from one or more second vendor devices; and
normalizing the data signals from the one or more first vendor devices and
the one or more second vendor devices to generate a plurality of homogenized
signals that can work together;
generating an urgent care report for the one or more patients, wherein the urgent care report includes one or more of:
a summary of the urgent care event of the one or more patients,
a justification as to why this is an urgent care event for the one or more patients, and
a recommendation for addressing the urgent care event of the one or more patients which is obvious over Welch et al. (US20070180140A1) ([0051] & [0088]) with the motivation to physiological information over a network as part of an alert notification (See Welch, Abstract) and further in view of Heckler et al. (US20150221045A1) ([0016] & [0025]-[0026]) with the motivation to improve efficiency with standardization (See Heckler, Background).
Dependent claims 2, 12, and 22 are an obvious variant of claims 2, 12, and 22 of 18/798,710 for reciting detecting one or more incidents defined within the plurality of data signals. Dependent claims 3, 13, and 23 are an obvious variant of claims 3, 13, and 23 of 18/798,710 for recitation of an incident includes the occurrence of one or more alarms. Dependent claims 4, 14, and 24 are an obvious variant of claims 4, 14, and 24 of 18/798,710 for reciting monitoring one or more data signals associated with a medical device utilized on a patient within the medical environment to detect the occurrence of the one or more alarms. Dependent claims 5, 15, and 25 are an obvious variant of claims 7, 17, and 27 of 18/798,710 for reciting utilizing massive data sets processed by ML to process the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event. The remaining dependent claims in the present application also recite substantially similar limitations to 18/798,710 such as various types of data signals, details of the medical device and/or uses of the medical device, and one or more sub-devices.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of the patent eligible subject matter because the broadest interpretation of the computer program product residing on a computer readable medium of claims 11-20 encompasses signals per se.
Claims 1-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process (claims 1-10) and a machine (claims 21-30).
INDEPENDENT CLAIMS
Step 2A Prong 1
Claim 1 recites steps of
A computer-implemented method, executed on a computing device, comprising: monitoring a plurality of data signals associated with a plurality of patients within a medical environment, including:
receiving data signals from one or more first vendor devices;
receiving data signals from one or more second vendor devices; and
normalizing the data signals from the one or more first vendor devices and
the one or more second vendor devices to generate a plurality of homogenized
signals that can work together;
processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event; and
if such an urgent care event is occurring, generating an urgent care report for the one or more patients, wherein the urgent care report includes one or more of:
a summary of the urgent care event of the one or more patients,
a justification as to why this is an urgent care event for the one or more patients, and
a recommendation for addressing the urgent care event of the one or more patients.
Claims 11 and 21 recites similar limitations as claim 1 but for the recitation of generic computer components.
These steps for creating an urgent report for the one or more patients, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. That is, nothing in the claim element precludes the italicized portions from managing personal behavior or relationships or interactions between people through organizing the activity around urgent care reporting for an urgent care event. This could be analogized to considering historical usage information while inputting data. If a claim limitation, under its broadest reasonable interpretation, covers performance as organizing human activity but for the recitation of generic computer components, then it falls within the “Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, the additional elements non-italicized portions identified above for claims 1, 11, and 21, does not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as
recitation of a computer-implemented method, executed on a computing device; within a virtual reality environment; a computer program product residing on a computer readable medium having a plurality of instructions stored thereon which, when executed by a processor, cause the processor to perform operations; and, a processor and memory amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving data signals from one or more first vendor devices; and, receiving data signals from one or more second vendor devices amounts to mere data gathering and output since it does not add meaningful limitations to the receiving actions performed, see MPEP 2106.05(g))
Each of the above additional elements therefore only amounts to mere instructions to implement functions within the abstract idea using generic computer components or other machines within their ordinary capacity, and also add insignificant extra-solution activity to the abstract idea. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. These elements are therefore not sufficient to integrate the abstract idea into a practical application. Therefore, the above claims, as a whole, are directed to an abstract idea.
Step 2B
The claim(s) 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 amount to no more than mere instructions to apply an exception and also add insignificant extra-solution activity to the abstract idea. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to mere instructions to apply an exception in particular fields such as recitation of a computer-implemented method, executed on a computing device; within a virtual reality environment; a computer program product residing on a computer readable medium having a plurality of instructions stored thereon which, when executed by a processor, cause the processor to perform operations; and, a processor and memory, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f).
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as recitation of receiving data signals from one or more first vendor devices; and, receiving data signals from one or more second vendor devices, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i).
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 generic computer implementation.
DEPENDENT CLAIMS
Step 2A Prong 1
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-10, 12-20, and 22-30 reciting particular aspects of creating an urgent report for the one or more patients such as
[Claims 2, 12, & 22] wherein processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event includes:
detecting one or more incidents defined within the plurality of data signals;
[Claims 3, 13, & 23] wherein an incident includes the occurrence of one or more alarms;
[Claims 4, 14, & 24] wherein detecting one or more incidents defined within the plurality of data signals includes:
monitoring one or more data signals associated with a medical device utilized on a patient within the medical environment to detect the occurrence of the one or more alarms;
[Claims 5, 15, & 25] wherein processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event includes:
utilizing massive data sets processed by ML to process the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event;
[Claims 6, 16, & 26] wherein generating an urgent care report for the one or more patients includes:
utilizing a generative AI model to generate the urgent care report for the one or more patients;
[Claims 7, 17, & 27] wherein utilizing a generative AI model to generate the urgent care report for the one or more patients includes:
utilizing prompt engineering and the generative AI model to generate the rounding list that prioritizes the plurality of patients;
[Claims 8, 18, & 28] wherein the plurality of data signals include one or more of:
one or more data signals associated with a medical device utilized on a patient within the medical environment;
one or more data signals associated with drugs administered to the patient within the medical environment;
one or more data signals associated with lab work performed on the patient within the medical environment;
one or more data signals associated with clinical assessments performed on the patient within the medical environment;
one or more data signals associated with clinical procedures performed on the patient within the medical environment;
one or more data signals associated with electronic health records and/or electronic medical records of the patient within the medical environment; and
one or more data signals associated with a medical history of the patient within the medical environment;
[Claims 9, 19, & 29] wherein the one or more data signals associated with a medical device utilized on a patient within the medical environment concern one or more details of the medical device and/or uses of the medical device;
[Claims 10, 20, & 30] wherein the medical device includes one or more sub-medical devices;
these italicized portions are methods of organizing human activity since they merely describe types of data and determinations that can be performed by humans.
Step 2A Prong 2
Dependent claims 4-10, 14-20, and 24-30 recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (the additional limitations in claims 5, 15, & 25 (processed by ML); claims 6, 16, & 26 (utilizing a generative AI model); and, claims 7, 17, & 27 (utilizing a generative AI model; and, utilizing prompt engineering and the generative AI model) amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f)); and, claims 4, 14, & 24 (with a medical device utilized); claims 8, 18, & 28 (with a medical device); claims 9, 19, & 29 (with a medical device utilized; and, of the medical device); and, claims 10, 20, & 30 (wherein the medical device includes one or more sub-medical devices) amounts to generally linking the abstract idea to a particular technological environment or field of use; as can be seen, employing generic computers to execute an abstract idea, even when limiting the use of the idea to one particular environment, does not add significantly more, 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.
Step 2B
Dependent claims 5-7, 15-17, and 25-27 recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, e.g., requiring the use of software to tailor information and provide it to the user on a generic computer, see Intellectual Ventures I LLC v. Capital One Bank, MPEP 2106.05(f). Dependent claims 4, 8-10, 14, 18-20, 24, and 28-30 recite additional subject matter
which, as discussed above with respect to integration of the abstract idea into a
practical application, amounts to generally linking the abstract idea to a particular
technological environment or field of use, e.g., simply an attempt to limit the use of the
abstract idea to a particular technological environment, Electric Power Group, LLC v.
Alstom S.A., MPEP 2105.05(h). There is no indication that these additional elements improve the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation. Therefore, in consideration of all the facts, the present invention is not a patent-eligible invention under USC 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148
USPQ 459 (1966), that are applied 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 1-5, 8-10, 11-15, 18-20, 21-25, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Katra et al. (US20200357513A1) in view of Welch et al. (US20070180140A1) and further in view of Heckler et al. (US20150221045A1).
Regarding claim 1, Katra discloses monitoring a plurality of data signals associated with a plurality of patients within a medical environment ([0048] “The computing device executing the app (e.g., a virtual check-in process) may perform various functionalities described below, whether via local computing resources provided by the computing device, via cloud-based backend systems, or both. In some examples, the computing device may implement the app via a web browser. In some examples, the computing device may perform a device check. In such examples, the computing device may implement one or more interrogations of one or more medical devices (e.g., IMDs, CIEDs, etc.). In addition, the computing device may analyze medical device settings, parameters, and performance metrics.” Also, see Figure 20.)
processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event ([0081] “In an example, medical device(s) 6 may include a device that predicts heart failure events or that detects worsening heart failure of patient 4. In a non-limiting and illustrative example, system 100 may be configured to measure impedance fluctuations of patient 4 and process impedance data to accumulate evidence of worsening heart failure. In any case, medical device(s) 6 may be configured to determine a health status relating to patient 4.” [0299] “In some examples, edge device(s) 12, medical device(s) 17 (e.g., IMD 6), server(s) 94, and/or computing device(s) 2 may use the gathered data to predict adverse health events (e.g., worsening infections) using integrated diagnostic methods.”)
Katra does not explicitly disclose however Welch teaches and if such an urgent care event is occurring, generating an urgent care report for the one or more patients ([0051] “provide management reporting on the alarm occurrence and response time, location management, and internal journaling of system performance metrics such as overall system uptime (see, e.g., FIG. 5 and accompanying description).”)
wherein the urgent care report includes one or more of:
a summary of the urgent care event of the one or more patients,
a justification as to why this is an urgent care event for the one or more patients, and
a recommendation for addressing the urgent care event of the one or more patients ([0088] “The risk report module 538 provides summary reports on alarm occurrences, duration of alarm, clinical response time to alarms and other statistical data to determine overall effectiveness of clinical response to alarms in compliance with JCAHO, other regulatory bodies, and internal quality assurance committees.”)
It would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra generating an urgent care report for the one or more patients, and the urgent care report includes one or more of: a summary of the urgent care event of the one or more patients, a justification as to why this is an urgent care event for the one or more patients, and a recommendation for addressing the urgent care event of the one or more patients as taught by Welch since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Katra in view of Welch does not explicitly disclose however Heckler teaches including: receiving data signals from one or more first vendor devices ([0025] “As is shown at block 102, a set of data including a plurality of transaction entries is imported or received, for instance, in comma-separated values (CSV) format. Each transaction entry can represent a single transaction between the hospital and a vendor.”)
receiving data signals from one or more second vendor devices ([0016] “receive a second data set that includes a plurality of transaction entries, each transaction entry comprising a plurality of different types of data including a vendor name and a transaction value”)
normalizing the data signals from the one or more first vendor devices and the one or more second vendor devices to generate a plurality of homogenized signals that can work together ([0026] “As is shown at block 104, the imported data is normalized, which can be performed in the manner shown and described with reference to FIG. 2 below. For instance, in certain embodiments, the process of filtering and normalizing the vendor names includes normalizing each of the plurality of transaction entries to a common format […] for easy matching”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra and Welch receiving data signals from one or more first vendor devices; receiving data signals from one or more second vendor devices; and normalizing the data signals from the one or more first vendor devices and the one or more second vendor devices to generate a plurality of homogenized signals that can work together as taught by Heckler since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Regarding claim 2, Katra discloses wherein processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event includes: detecting one or more incidents defined within the plurality of data signals ([0155] “transmit the abnormality results to edge device(s) 12 for reporting purposes, e.g., for providing an alert to patient 4 or another user” [0284] “In an illustrative example, where processing circuitry 20 labels a result for an image as comprising a ‘potential infection,’ processing circuitry 20 may generate an alert and provide an alert indication to one or more HCPs (e.g., via UI 22). The alert indication may include a summary of the result, a post-implant report, one or more images, and in some instances, highlighting of the images to indicate characteristics of the potential abnormality.”)
Regarding claim 3, Katra discloses wherein an incident includes the occurrence of one or more alarms ([0298] “In some examples, processing circuitry 20 may provide an alert, such as a text- or graphics-based notification, a visual notification, etc. In some examples, processing circuitry 20 may cause an audible alarm to sound or cause a tactile alarm, alerting patient 4 of a determined abnormality […] The alert may indicate a potential, possible or predicted abnormality event (e.g., a potential infection).”)
Regarding claim 4, Katra discloses wherein detecting one or more incidents defined within the plurality of data signals includes: monitoring one or more data signals associated with a medical device utilized on a patient within the medical environment to detect the occurrence of the one or more alarms ([0132] “In some examples, computing device(s) 2 may transmit data regarding images, infection or other abnormality indications” [0133] “an alert to patient 4 (or relay an alert determined by medical device(s) 17, edge device(s) 12, or server(s) 94) based on an abnormality determined from a combination of data items, which may enable patient 4 proactively to seek medical attention prior to receiving instructions for a medical intervention.”)
Regarding claim 5, Katra discloses wherein processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event includes: utilizing massive data sets processed by ML to process the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event ([0103] “A trained ML model 30 and/or AI engine 28 may be configured to process and analyze the user input (e.g., images of the implantation site, patient status data, etc.), device parameters (e.g., accelerometer data), historical data of medical device (e.g., medical device 6), and/or physiological parameters, in accordance with certain examples of this disclosure where ML models are considered advantageous (e.g., predictive modeling, inference detection, contextual matching, natural language processing, etc.). [0099] “an alert to patient 4 and/or other users when combination of patient health data (e.g., implantation site images, ECG parameters, etc.), medical device diagnostic data, and indicates the onset of an abnormality”)
Regarding claim 8, Katra discloses wherein the plurality of data signals include one or more of:
one or more data signals associated with a medical device utilized on a patient within the medical environment;
one or more data signals associated with drugs administered to the patient within the medical environment;
one or more data signals associated with lab work performed on the patient within the medical environment;
one or more data signals associated with clinical assessments performed on the patient within the medical environment;
one or more data signals associated with clinical procedures performed on the patient within the medical environment;
one or more data signals associated with electronic health records and/or electronic medical records of the patient within the medical environment; and
one or more data signals associated with a medical history of the patient within the medical environment ([0080] “In some examples, the tools of this disclosure may be configured to monitor functioning of or user adaptation to implants other than CIEDs, such as spinal cord stimulators, deep brain stimulators, gastrological stimulators, urological stimulators, other neurostimulators, orthopedic implants, respiratory monitoring implants, etc.” [0081] “In some examples, medical device(s) 6 may include diagnostic medical devices. In an example, medical device(s) 6 may include a device that predicts heart failure events or that detects worsening heart failure of patient 4.”)
Note: cited to the medical device limitation.
Regarding claim 9, Katra discloses wherein the one or more data signals associated with a medical device utilized on a patient within the medical environment concern one or more details of the medical device and/or uses of the medical device ([0081] “In an example, medical device(s) 6 may include a device that predicts heart failure events or that detects worsening heart failure of patient 4. In a non-limiting and illustrative example, system 100 may be configured to measure impedance fluctuations of patient 4 and process impedance data to accumulate evidence of worsening heart failure. In any case, medical device(s) 6 may be configured to determine a health status relating to patient 4.” Also, see Figure 14.)
Regarding claim 10, Katra discloses wherein the medical device includes one or more sub-medical devices ([0141] “In some examples, electrodes 16 may be configured for implantation outside of a thorax of patient 4. In some examples, the housing of medical device(s) 17 may be used as an electrode in combination with electrodes located on leads. In some examples, medical device(s) 17 may be configured to measure impedance changes within the interstitial fluid of patient 4, ECG morphology changes, etc. For example, medical device(s) 17 may be configured to receive one or more signals indicative of a subcutaneous tissue impedance.” Also see [0075] “In another example, the image data may include a frame of a still-image of areas of the body of patient 4 adjacent the implantation site, such as where leads may be routed beneath the skin of patient 4.”)
Regarding claim 11, Katra discloses A computer program product residing on a computer readable medium having a plurality of instructions stored thereon which, when executed by a processor, cause the processor to perform operations ([0383] “In some implementations, the above-described Examples 1-38 and/or 39-79 can be implemented using a computer-readable storage medium storing instructions that when executed cause one or more processors of a device to perform some or all of the various operations.”)
monitoring a plurality of data signals associated with a plurality of patients within a medical environment ([0048] “The computing device executing the app (e.g., a virtual check-in process) may perform various functionalities described below, whether via local computing resources provided by the computing device, via cloud-based backend systems, or both. In some examples, the computing device may implement the app via a web browser. In some examples, the computing device may perform a device check. In such examples, the computing device may implement one or more interrogations of one or more medical devices (e.g., IMDs, CIEDs, etc.). In addition, the computing device may analyze medical device settings, parameters, and performance metrics.” Also, see Figure 20.)
processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event ([0081] “In an example, medical device(s) 6 may include a device that predicts heart failure events or that detects worsening heart failure of patient 4. In a non-limiting and illustrative example, system 100 may be configured to measure impedance fluctuations of patient 4 and process impedance data to accumulate evidence of worsening heart failure. In any case, medical device(s) 6 may be configured to determine a health status relating to patient 4.” [0299] “In some examples, edge device(s) 12, medical device(s) 17 (e.g., IMD 6), server(s) 94, and/or computing device(s) 2 may use the gathered data to predict adverse health events (e.g., worsening infections) using integrated diagnostic methods.”)
Katra does not explicitly disclose however Welch teaches and if such an urgent care event is occurring, generating an urgent care report for the one or more patients ([0051] “provide management reporting on the alarm occurrence and response time, location management, and internal journaling of system performance metrics such as overall system uptime (see, e.g., FIG. 5 and accompanying description).”)
wherein the urgent care report includes one or more of:
a summary of the urgent care event of the one or more patients,
a justification as to why this is an urgent care event for the one or more patients, and
a recommendation for addressing the urgent care event of the one or more patients ([0088] “The risk report module 538 provides summary reports on alarm occurrences, duration of alarm, clinical response time to alarms and other statistical data to determine overall effectiveness of clinical response to alarms in compliance with JCAHO, other regulatory bodies, and internal quality assurance committees.”)
It would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra generating an urgent care report for the one or more patients, and the urgent care report includes one or more of: a summary of the urgent care event of the one or more patients, a justification as to why this is an urgent care event for the one or more patients, and a recommendation for addressing the urgent care event of the one or more patients as taught by Welch since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Katra in view of Welch does not explicitly disclose however Heckler teaches including: receiving data signals from one or more first vendor devices ([0025] “As is shown at block 102, a set of data including a plurality of transaction entries is imported or received, for instance, in comma-separated values (CSV) format. Each transaction entry can represent a single transaction between the hospital and a vendor.”)
receiving data signals from one or more second vendor devices ([0016] “receive a second data set that includes a plurality of transaction entries, each transaction entry comprising a plurality of different types of data including a vendor name and a transaction value”)
normalizing the data signals from the one or more first vendor devices and the one or more second vendor devices to generate a plurality of homogenized signals that can work together ([0026] “As is shown at block 104, the imported data is normalized, which can be performed in the manner shown and described with reference to FIG. 2 below. For instance, in certain embodiments, the process of filtering and normalizing the vendor names includes normalizing each of the plurality of transaction entries to a common format […] for easy matching”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra and Welch receiving data signals from one or more first vendor devices; receiving data signals from one or more second vendor devices; and normalizing the data signals from the one or more first vendor devices and the one or more second vendor devices to generate a plurality of homogenized signals that can work together as taught by Heckler since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Regarding claim 12, the limitations are rejected for the same reasons as stated above for claim 2.
Regarding claim 13, the limitations are rejected for the same reasons as stated above for claim 3.
Regarding claim 14, the limitations are rejected for the same reasons as stated above for claim 4.
Regarding claim 15, the limitations are rejected for the same reasons as stated above for claim 5.
Regarding claim 18, the limitations are rejected for the same reasons as stated above for claim 8.
Regarding claim 19, the limitations are rejected for the same reasons as stated above for claim 9.
Regarding claim 20, the limitations are rejected for the same reasons as stated above for claim 10.
Regarding claim 21, Katra discloses A computing system including a processor and memory configured to perform operations ([0015] “one or more processors in communication with the memory”)
monitoring a plurality of data signals associated with a plurality of patients within a medical environment ([0048] “The computing device executing the app (e.g., a virtual check-in process) may perform various functionalities described below, whether via local computing resources provided by the computing device, via cloud-based backend systems, or both. In some examples, the computing device may implement the app via a web browser. In some examples, the computing device may perform a device check. In such examples, the computing device may implement one or more interrogations of one or more medical devices (e.g., IMDs, CIEDs, etc.). In addition, the computing device may analyze medical device settings, parameters, and performance metrics.” Also, see Figure 20.)
processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event ([0081] “In an example, medical device(s) 6 may include a device that predicts heart failure events or that detects worsening heart failure of patient 4. In a non-limiting and illustrative example, system 100 may be configured to measure impedance fluctuations of patient 4 and process impedance data to accumulate evidence of worsening heart failure. In any case, medical device(s) 6 may be configured to determine a health status relating to patient 4.” [0299] “In some examples, edge device(s) 12, medical device(s) 17 (e.g., IMD 6), server(s) 94, and/or computing device(s) 2 may use the gathered data to predict adverse health events (e.g., worsening infections) using integrated diagnostic methods.”)
Katra does not explicitly disclose however Welch teaches and if such an urgent care event is occurring, generating an urgent care report for the one or more patients ([0051] “provide management reporting on the alarm occurrence and response time, location management, and internal journaling of system performance metrics such as overall system uptime (see, e.g., FIG. 5 and accompanying description).”)
wherein the urgent care report includes one or more of:
a summary of the urgent care event of the one or more patients,
a justification as to why this is an urgent care event for the one or more patients, and
a recommendation for addressing the urgent care event of the one or more patients ([0088] “The risk report module 538 provides summary reports on alarm occurrences, duration of alarm, clinical response time to alarms and other statistical data to determine overall effectiveness of clinical response to alarms in compliance with JCAHO, other regulatory bodies, and internal quality assurance committees.”)
It would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra generating an urgent care report for the one or more patients, and the urgent care report includes one or more of: a summary of the urgent care event of the one or more patients, a justification as to why this is an urgent care event for the one or more patients, and a recommendation for addressing the urgent care event of the one or more patients as taught by Welch since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Katra in view of Welch does not explicitly disclose however Heckler teaches including: receiving data signals from one or more first vendor devices ([0025] “As is shown at block 102, a set of data including a plurality of transaction entries is imported or received, for instance, in comma-separated values (CSV) format. Each transaction entry can represent a single transaction between the hospital and a vendor.”)
receiving data signals from one or more second vendor devices ([0016] “receive a second data set that includes a plurality of transaction entries, each transaction entry comprising a plurality of different types of data including a vendor name and a transaction value”)
normalizing the data signals from the one or more first vendor devices and the one or more second vendor devices to generate a plurality of homogenized signals that can work together ([0026] “As is shown at block 104, the imported data is normalized, which can be performed in the manner shown and described with reference to FIG. 2 below. For instance, in certain embodiments, the process of filtering and normalizing the vendor names includes normalizing each of the plurality of transaction entries to a common format […] for easy matching”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra and Welch receiving data signals from one or more first vendor devices; receiving data signals from one or more second vendor devices; and normalizing the data signals from the one or more first vendor devices and the one or more second vendor devices to generate a plurality of homogenized signals that can work together as taught by Heckler since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art
Regarding claim 22, the limitations are rejected for the same reasons as stated above for claim 2.
Regarding claim 23, the limitations are rejected for the same reasons as stated above for claim 3.
Regarding claim 24, the limitations are rejected for the same reasons as stated above for claim 4.
Regarding claim 25, the limitations are rejected for the same reasons as stated above for claim 5.
Regarding claim 28, the limitations are rejected for the same reasons as stated above for claim 8.
Regarding claim 29, the limitations are rejected for the same reasons as stated above for claim 9.
Regarding claim 30, the limitations are rejected for the same reasons as stated above for claim 10.
Claims 6, 16, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Katra et al. (US20200357513A1) in view of Welch et al. (US20070180140A1), Heckler et al. (US20150221045A1), and further in view of Nesarikar et al. (US20210398236A1).
Regarding claim 6, Katra in view of Welch and Heckler does not explicitly disclose however Nesarikar teaches wherein generating an urgent care report for the one or more patients includes: utilizing a generative AI model to generate the urgent care report for the one or more patients ([0107] “In an embodiment, AI may be an artificial neural network (ANN). […] An ANN may be of a basis comprising at least one of: static, temporal, generative, generative-adversarial, reinforcement learning, and combination thereof.” [0104] “In an embodiment, a first system may generate one or more intelligence in response to an event (e.g., high-severity), wherein the one or more intelligence is in the form of a second system (e.g., an AI, an AI system, etc.) created (e.g., induced, conceived, developed, improved, deployed, and combination thereof) by the first system. Thereafter, one or more response (e.g., of type comprising at least one of prediction, intelligence, alert, message, report, record, and combination thereof) to the event”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra, Welch, and Heckler utilizing a generative AI model to generate the urgent care report for the one or more patients as taught by Nesarikar since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Regarding claim 16, the limitations are rejected for the same reasons as stated above for claim 6.
Regarding claim 26, the limitations are rejected for the same reasons as stated above for claim 6.
Claims 7, 17, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Katra et al. (US20200357513A1) in view of Welch et al. (US20070180140A1), Heckler et al. (US20150221045A1), Nesarikar et al. (US20210398236A1), and further in view of Rezaeian et al. (US20250022595A1).
Regarding claim 7, Katra in view of Welch, Heckler, and Nesarikar does not explicitly disclose however Rezaeian teaches wherein utilizing a generative AI model to generate the urgent care report for the one or more patients includes: utilizing prompt engineering and the generative AI model to generate the rounding list that prioritizes the plurality of patients ([0024] “Prompt engine 134 receives a summary note, automatically generates a prompt, and sends the prompt and summary note to LLM 136.” [0032] “In an embodiment, prompt engine 134 (or another component of system 130) analyzes output generated by LLM 136 before the output is transmitted to recommendation model 140 as input.” [0053] “In an embodiment, in response to a positive selection (by curator 160) of a reference to a candidate medical item in a re-ranked list, order database 148 is updated to include a new entry that identifies the physician in question, the patient in question, and the selected medical item. For example, the presented list of re-ranked candidates has metadata that includes a physician identifier, a patient identifier, and a medical item identifier for each candidate medical item in the re-ranked list.”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Katra, Welch, Heckler, and Nesarikar utilizing prompt engineering and the generative AI model to generate the rounding list that prioritizes the plurality of patients as taught by Rezaeian since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
Regarding claim 17, the limitations are rejected for the same reasons as stated above for claim 7.
Regarding claim 27, the limitations are rejected for the same reasons as stated above for claim 7.
Response to Arguments
The arguments filed on 2026 March 18 have been considered, but are not fully persuasive.
Regarding the title objection, applicant has submitted a new title that is descriptive. Therefore, the title objection has been withdrawn.
Regarding the drawing objection, applicant has submitted new drawings that are clear and has amended the specification to include the missing reference numerals. Therefore, the drawing objection has been withdrawn.
Regarding the double patenting rejection, the applicant states that the claims in the subject patent application have not yet been allowed and applicant requests that this rejection be held in abeyance pending the holding of such allowable claims where upon the holding of such allowable claims, applicant is amenable to filing any terminal disclaimers as may be appropriate.
Examiner disagrees with the applicant and points out MPEP 804 clearly states that if an applicant does not file a terminal disclaimer or show the claims are patentably distinct, then it is technically an incomplete response i.e., non-responsive. MPEP 804 also states that the filing of a terminal disclaimer should not be held in abeyance when the double patenting rejection is present. There is also no allowable subject matter presently. Therefore, the double patenting rejection is maintained.
Regarding the USC 112(b) rejection, applicant has amended claims 12-20 to recite "The computer program product," and claims 22-30 have been amended to recite "The computing system." Therefore, the USC 112(b) rejection has been withdrawn.
Regarding the USC 101 rejection, applicant asserts that the amended claims are not believed to be directed toward an abstract idea. Further, even if the claims could be considered to include an abstract idea, any such abstract idea is believed to be incorporated into a practical application. Applicant requests withdrawal of the USC 101 rejection.
Examiner disagrees with the applicant’s argument. Examiner asserts the present amendments/claim construction does not advance prosecution to help overcome USC 101. Applicant is merely using computers to improve upon the judicial exception. The invention does not describe a new way for the computer itself to function. Applicant’s current claims aren’t meaningful and do not help integrate the judicial exception into a practical application. The examiner asserts the following facts that the applicant won’t be able to dispute:
1) the invention does NOT involve a novel algorithm or data structure that significantly improves the computer's functionality,
2) the invention does NOT involve a new hardware component or configuration that works with the computer to achieve a specific technical benefit, and
3) the computer is NOT used in a completely new way demonstrating a significant technical advancement.
The claim appears directed to the result (achieving a better outcome) rather than a technical solution to a technical problem. To show an involvement of a computer assists in improving technology, the claims must recite details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology (MPEP 2106.05(a)(II)). The "significantly more" standard has also not been satisfied. The applicant has not demonstrated that their invention is inventive and thus the present invention is still not patent-eligible under USC 101. Therefore, the USC 101 rejection is maintained.
Regarding the USC 101 rejection, applicant’s arguments have been considered but are moot since they do not apply to the newly cited reference of record: Heckler.
Prior Art Cited but Not Relied Upon
Singh, D., Celik, A., Zhang, E. W., Liu, E., & Rosenfield, D. (2025). AI-driven injury reporting in pediatric emergency departments. JAMA Network Open, 8(7), e2524154-e2524154.
This reference is relevant because it discloses using artificial intelligence to generate urgent care report.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/WINSTON R FURTADO/Examiner, Art Unit 3687
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