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 .
Notice to Applicant
Claims 1-20 remain pending and are examined hereinbelow.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 27, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-20 are directed to controlling sharing of medical information, which is considered facilitating interactions between people. Facilitating interactions between people falls within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea).
Under step 1 of the Alice/Mayo framework, it must be considered whether the claims are directed to one of the four statutory classes of invention. In the instant case, claim 1-9 recite a system comprising a memory and a processor. Claims 10-18 recite a method and at least one step. Claims 19-20 recite a non-transitory computer-readable medium. Therefore, the claims are each directed to one of the four statutory categories of invention (process, apparatus, manufacture).
Under step 2A of the Alice/Mayo framework, it must be considered whether the claims are “directed to” an abstract idea. That is, whether the claims recite an abstract idea and fail to integrate the abstract idea into a practical application.
Regarding independent claim 1, the claim sets forth a process for controlling sharing of medical information, which is considered facilitating interactions between people, in the following limitations:
receive patient data attributes of patient data collected and an indication for the patient data;
generate, based at least on the patient data attributes of the patient data, a set of transmission parameters to adhere to when sending any of the patient data;
send the set of transmission parameters;
receive at least a subset of the patient data in response to sending the set of transmission parameters, wherein the subset of the patient data is in compliance with the set of transmission parameters; and
provide the subset of the patient data.
The above-recited limitations establish controlling sharing of medical information, which is considered facilitating interactions between people. This arrangement amounts to facilitating interactions between people. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)).
Claim 1 does recite additional elements:
from a medical device
of a destination computer
data processing capabilities of the destination computer.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“from a medical device”, “of a destination computer”, “data processing capabilities of the destination computer”) and insignificant pre-and-post solution activity (receiving, generating, sending, receiving, and providing). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 28, 30, 32-34, and 77-81 indicate that while exemplary general purpose systems may be specific for descriptive purposes, any elements or combinations of elements capable of implementing the claimed invention are acceptable. That is, the technology used to implement the invention is not specific or integral to the claim.
Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea.
Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea
Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Communicating information (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent.
Independent Claims 10 and 19 are parallel in scope to claim 1 and ineligible for similar reasons.
Dependent claims
Each of these steps of the dependent claims 2-9, 11-18, and 20 only serve to further limit or specify the features of independent claims 1, 10, and 19 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements already analyzed in the expected manner
For example, Claim 2 sets forth:
wherein the patient data attributes comprise at least one of data formats of the patient data, a data size of the patient data, quality of service parameters associated with sending the patient data, sending the patient data, a prioritization metric associated with at least some of the patient data, a fidelity metric for sending at least some of the patient data, a time range for sending at least some of the patient data, or an urgency metric for delivering the patient data.
Such a recitation merely embellishes the abstract idea of controlling sharing of medical information, which is considered facilitating interactions between people. Facilitating interactions between people falls within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). While the claim does set forth the additional limitation of “to the server”, “available communication mediums for”, “to the server”, “to the destination computer”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication Number 2009/0069642, Gao, et al., hereinafter Gao.
Regarding claim 1, Gao discloses a server comprising:
a memory, (para. 44); and
a processor coupled to the memory, (para. 44), the processor configured to:
receive, from a medical device, patient data attributes of patient data collected by the medical device and an indication of a destination computer for the patient data, (para. 48, the attributes for each patient data input to be monitored);
generate, based at least on data processing capabilities of the destination computer and the patient data attributes of the patient data, a set of transmission parameters for the medical device to adhere to when sending any of the patient data, (para. 25, this patient data can be analyzed to adjust the parameters of data collection, adjust the parameters of data transmission);
send the set of transmission parameters to the medical device, (para. 25, this patient data can be analyzed to adjust the parameters of data collection, adjust the parameters of data transmission and para. 98, wearable monitoring device is set (e.g., by a nurse) to "step-down unit monitoring mode");
receive at least a subset of the patient data from the medical device in response to sending the set of transmission parameters to the medical device, wherein the subset of the patient data is in compliance with the set of transmission parameters, (para. 39, A processor 103 may process all or a subset of the collected patient data from the data collectors and para. 87, the monitor may be set to receive patient data for all or a subset); and
provide the subset of the patient data to the destination computer, (para. 49, may continuously or periodically report the monitored patient data (or a subset of the patient data) by sending it to a client processor or server).
Regarding claim 2, Gao discloses the server of claim 1 as described above. Gao further discloses wherein the patient data attributes comprise at least one of data formats of the patient data, a data size of the patient data, quality of service parameters associated with sending the patient data to the server, available communication mediums for sending the patient data to the server, a prioritization metric associated with at least some of the patient data, a fidelity metric for sending at least some of the patient data, a time range for sending at least some of the patient data, or an urgency metric for delivering the patient data to the destination computer, (para. 83, A dynamically reconfigurable patient monitor may reconfigure its performance parameters, including: monitoring parameters, specificity and sensitivity of alert detection parameters, types of alert detections used, data collection parameters, sampling rate of sensors, accuracy (floating point integer size) of sensed data, types of sensed data, wireless parameters, frequency of wireless transmission, storage parameters, frequency of storage, size of storage, types of storage, etc.).
Regarding claim 3, Gao discloses the server of claim 1 as described above. Gao further discloses wherein the set of transmission parameters indicates the subset of the patient data and a communications means for sending the subset of the patient data, (para. 25, this patient data can be analyzed to adjust the parameters of data collection, adjust the parameters of data transmission and para.83, A dynamically reconfigurable patient monitor may reconfigure its performance parameters, including: monitoring parameters, specificity and sensitivity of alert detection parameters, types of alert detections used, data collection parameters, sampling rate of sensors, accuracy (floating point integer size) of sensed data, types of sensed data, wireless parameters, frequency of wireless transmission, storage parameters, frequency of storage, size of storage, types of storage, etc. These performance parameters may be adjusted by modifying or providing a new set of monitor configuration instructions, indicating which patient data inputs to monitor (e.g., what sensor, what treatment devices, etc.), how these patient data inputs should be monitored (e.g., parameters for monitoring them), control information (e.g., instructions for controlling treatment devices or sensors), algorithm information (including any instructions for analyzing and/or presenting patient data), alert or analysis parameters, etc.).
Regarding claim 4, Gao discloses the server of claims 1 and 3 as described above. Gao further discloses wherein the communications means for sending the subset of the patient data corresponds to a cellular communications means or an Institute of Electrical and Electronics Engineers (IEEE) 802.11 communications means, (para. 96, Transmission to the server is via a global network, such as cellular, satellite, or WiMax.).
Regarding claim 5, Gao discloses the server of claim 1 as described above. Gao further discloses wherein, in response to a determination that a first format of data is not compatible with the data processing capabilities of the destination computer, the set of transmission parameters indicates to the medical device to bypass transmission of patient data having the first format, (para. 138, This controller may also process information sent by the device, including formatting data (e.g., into packets, sentences, or any other appropriate format), adding error-correction codes, encryption, etc.)).
Regarding claim 6, Gao discloses the server of claim 1 as described above. Gao further discloses wherein the processor is further configured to:
send a query to the destination computer in response to receiving the patient data attributes and the indication of the destination computer from the medical device, (para. 25, this patient data can be analyzed to adjust the parameters of data collection, adjust the parameters of data transmission and para. 87, The monitor configuration instructions may also indicate the patient data input parameters for each of these patient data inputs, such as parameters instructing the monitor to confirm (or request) connection to the appropriate data input device, and parameters controlling the sample rate, gain, etc., for each patient data input.),
wherein the query includes a request for the data processing capabilities of the destination computer, (para. 25, this patient data can be analyzed to adjust the parameters of data collection, adjust the parameters of data transmission and para. 138, This controller may also process information sent by the device, including formatting data (e.g., into packets, sentences, or any other appropriate format), adding error-correction codes, encryption, etc.)); and
receive an indication of the data processing capabilities of the destination computer in response sending the query, (para. 134, Data from devices of lesser capability may be sent to devices of greater capability for storage, processing, or display. Thus, each device can act as a data source, a data forwarder, or a data sink (i.e., a data recipient).).
Regarding claim 7, Gao discloses the server of claim 1 as described above. Gao further discloses wherein the processor is further configured to:
periodically send a query to destination computer, wherein the query includes a request for the data processing capabilities of the destination computer, (para. 25, this patient data can be analyzed to adjust the parameters of data collection, adjust the parameters of data transmission, and para. 134, Data from devices of lesser capability may be sent to devices of greater capability for storage, processing, or display. Thus, each device can act as a data source, a data forwarder, or a data sink (i.e., a data recipient) and para. 138, This controller may also process information sent by the device, including formatting data (e.g., into packets, sentences, or any other appropriate format), adding error-correction codes, encryption, etc.)); and
receive an indication of the data processing capabilities of the destination computer in response sending each query, (para. 134, Data from devices of lesser capability may be sent to devices of greater capability for storage, processing, or display. Thus, each device can act as a data source, a data forwarder, or a data sink (i.e., a data recipient).).
Regarding claim 8, Gao discloses the server of claim 1 as described above. Gao further discloses wherein the data processing capabilities of the destination computer indicate an availability of the destination computer to receive the patient data, an amount of available storage at the destination computer, and different formats of data that are able to be processed by the destination computer, (para. 134, the processor of monitors A-D and the multimonitor or client monitor M may determine which data should be displayed on the local device or on a remote device, which data should be processed on the local device versus a remote device, and which data should be stored on the local device, versus a remote device. Data from devices of lesser capability may be sent to devices of greater capability for storage, processing, or display. Thus, each device can act as a data source, a data forwarder, or a data sink (i.e., a data recipient). The data transmitted and received by the devices may be associated with a single patient, associated with multiple patients, or not associated with any particular patient.).
Regarding claim 9, Gao discloses the server of claim 1 as described above. Gao further discloses wherein the medical device comprises a defibrillator or a patient monitoring device, (para. 27, a reconfigurable patient monitor may be used to track a patient's progress and current condition (e.g., to monitor vitals), to track their treatment (e.g., prescriptions, diagnosis, etc.), to track and control treatment by one or more treatment devices (e.g., dialysis machines, infusion pump, IV-PCA, or any other bedside patient treatment device), to track additional patient conditions monitored by another monitoring device, to track the patient's physical location (e.g., by GPS), to receive and store caregiver inputs (e.g., text comments, voice comments, image inputs, etc.), and to collect data on workflow processes (e.g., a disaster casualty has passed through the decontamination tent, a resident of a refugee camp has collected rations at the food tent, a rehabilitation patient has done the exercises in a rehabilitation routine, etc.).).
Regarding claims 10-18, these claims are rejected for the same reasons as set forth above with regard to claims 1-9.
Regarding claims 19-20, these claims are rejected for the same reasons as set forth above with regard to claims 1 and 9. Gao further discloses a non-transitory computer-readable medium comprising instructions that, when executed by a processor within a server, causes the processor to perform operations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
APPARATUS FOR FACILITATING SECURE EXCHANGE OF MEDICAL DATA PERTAINING TO A USER, SYSTEM AND METHOD THEREOF (US 20210158921 A1) teaches an apparatus and system for remote health applications that are compliant with Health Insurance Portability and Accountability Act (HIPAA).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amber Misiaszek whose telephone number is 571-270-1362. The examiner can normally be reached M-F 8:00-5:30, First Friday Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER A MISIASZEK/Primary Examiner, Art Unit 3682