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
Receipt of Applicant’s Amendment filed August 6, 2025 is acknowledged.
Response to Amendment
Claims 1, 4-5, 7, 15, and 17-19 have been amended. Claims 2-3, 6, 8-14, and 16 have not been modified. Claim 20 has been added. Claims 1-20 are pending and are provided to be examined upon their merits.
Response to Arguments
Applicant’s arguments filed July 7, 2025 have been fully considered but they are not persuasive. A response is provided below.
Applicant argues Drawing Objections, pg. 6 of Remarks:
No drawing amendments have been filed. Thus, the drawing objections are maintained.
Applicant argues 35 U.S.C. §112 Rejections, pg. 9 of Remarks:
Examiner acknowledges Applicant amendments and withdraws the previous §112b rejections. However, Applicant amendments have caused new §112(a) and 112(b) rejections. Please see below.
Applicant argues 35 U.S.C. §101 Rejections, pg. 11 of Remarks:
Regarding Step 2A, Prong One, Applicant argues that the Examiner’s characterization of the abstract idea is overly broad and does not consider the specific technological context and detailed implantation of the claimed method. Examiner respectfully disagrees. Specific technological context (additional elements identified as edge-side devices, pairing of devices, blockchain) is considered under Step 2A, Prong Two. The claimed method steps, such as executing real-time context-aware rules, processing of collected data to perform location and time synchronization, verifying (i) patient ID, (ii) time that a patient was present at a location, and (iii) correlation with the data collected at that location, storing and analyzing data, polling to identify and recover lost data are all considered part of the abstract idea under certain methods of organizing human activity as these limitations may otherwise be performed by actions of a hospital data analyst.
Regarding Step 2A, Prong Two, Applicant argues that (1) pairing devices, (2) real-time context-aware rule execution, (3) location and time synchronization, (4) three-element validation, and (5) polling mechanisms for lost data together provide a practical application. Examiner respectfully disagrees.
(1) Pairing devices is a generic feature that only performed to allow the insignificant extra-solution activity of transmitting data between the paired devices. No specific improvements are made to device-device communication as the pairing itself is generic.
(2) Real-time context-aware rule execution has no application as the rules that are being executed, the purpose of those rules, and the determination of a rule execution latency are not claimed or supported by Applicant specification. Thus, they do not represent an improvement over other systems in the field.
(3) Location and time synchronization is considered to be part of the abstract idea as it can be otherwise performed through the actions of a medical data analyst as synchronizing data is simply ensuring that the timestamps and location metadata are consistent across datasets and simply is a form of data verification.
(4) The three-element validation, as recited above, consists of verifying (i) patient ID, (ii) time that a patient was present at a location, and (iii) correlation with the data collected at that location. These actions are also considered to be part of the abstract idea as they can be otherwise performed through the actions of a medical data analyst through simply verifying data, as indicated by [0046] of Applicant specification: “An active healthcare professional, or someone that has been assigned to verify the patient data, patient location or patient identification, confirms the three key elements of the patient data triplets: patient identification and its code 134, segment or segments of time the patient was on location 135, and patient data collected at that location 109, 136 throughout the active process 103, 123.”
(5) Polling mechanisms are also considered part of the abstract process as it can also be performed through a medical data analyst, as indicated by [0056] of Applicant specification: “The lost data can be polled in response to the system notifying servers 220 that there was missing or incomplete information. The determination of missing or incomplete information may be done by automated processes, a healthcare professional, or both.”
Regarding Step 2B, the consideration is if the additional elements (in the independent claim: digital black box, edge-side device, medical device, blockchain, servers, communication network), alone or in combination, are well-understood, routine and conventional in the field – the novelty of the abstract idea is not considered relevant under the Step 2B analysis. Here, the additional elements, alone or in combination, amount to instruction to implement the abstract idea using general purpose computers. Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014).
Applicant argues 35 U.S.C. §102 Rejections, pg. 15 of Remarks:
Examiner agrees with Applicant that the §102 rejection is overcome by the claim amendments. Please see the modified §103 rejection below.
Applicant argues 35 U.S.C. §103 Rejections, pg. 18 of Remarks:
Applicant argues that there is no motivation to combine Murrish with Fuchs, as the combination fails to teach the claim amendments. The Examiner respectfully disagrees as Fuchs was not relied upon previously to teach the newly introduced claim amendments. Additionally, as recited in the previous Non-Final office action supplied on May 15, 2025, the motivation to combine Murrish with Fuchs is because Murrish in view of Fuchs are considered analogous to the claimed invention because they are in the field of patient data processing and transmission. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Murrish with Fuchs for the advantage of “request[ing] data that [the mobile application] has missed during the period of disconnection” (Fuchs; [0181]).
However, new art is introduced to address the amended claim limitations.
Drawings
The drawings are objected to because:
Each figure element must be denoted using only a single number. For example, reference numbers like 7,27 must be given a new number designation as it cannot be made of two numbers put together.
In Fig. 2, numbers 1, 2, and 3 are used to denote three separate elements: the Digital Black Box Recording, Positive Patient Identification and Data Validation, and True Source of Data and Data Export steps respectively; the proper patient identification process 123, proper data entry of metadata 122, and previous location and metadata setup of MDDS 121; active healthcare professional confirmation of patient location time presence 103, location 102, and previous location and metadata setup of MDDS 101. Examiner requests that different numbers are used to denote these three series of elements or be removed from the latter two series.
In paragraph [0035], reference numbers 2 and 3 are used to represent elements that are not labelled in Fig. 4.
In Fig. 5, there is an additional element off to the side that resembles Signature 44 that is unlabeled and appears to be separate from the body of the figure. The Examiner requests that this be removed for clarity.
In Fig. 7, there is an additional element off to the side that resembles Fig. 5. The Examiner requests that this be removed for clarity.
In Fig. 9, “data session records 145” are not labelled despite being mentioned in paragraph [0051].
There are many instances of figure elements having several corresponding reference numbers despite being the same element. For example, in Fig. 2, reference numbers 121 and 101 are both used to refer to the same element; previous location and metadata setup of MDDS. In this specific instance, the Examiner requests that the applicant grants all instances of previous location and metadata setup of MDDS in Fig. 2 with reference number 101.
In another example, in Fig. 6, the MDDS is given reference numbers 55, 68, 78, 86, and 94. In this specific instance, the Examiner requests that the applicant grants all instances of the MDDS in Fig. 6 with reference number 55. Examiner further requests that all such instances are identified by the applicant and corrects the drawings so each element corresponds to only one reference number.
The Examiner requests that figures 2-9 be redrawn for organizational clarity of the figure. For example, in Fig. 2, as it is difficult to discern what reference numbers refer to what figure element, especially where reference numbers 74,75,76 are located.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended independent claim 1 recites new matter that is not supported by Applicant specification. Specifically, the claims introduce new matter of pairing of an edge-side device having serial, Ethernet, USB, and wireless communication ports and executing context-aware rules under a predetermined rule execution latency threshold. [0022] describes wherein “Hospital medical devices, continuous monitoring systems and laboratory devices 53, 66, through the use of proper physical and software drivers 7, 27 are collected by Medical Device Data System (MDDS) devices”. [0023] further recites: “Wearables and home or community care data and sensors 84, generally available through BLE (Blue Tooth Low Energy, BT4.1) wireless protocol 85, can be registered and time synchronized by portable MDDS device or phone application 86, and available or optionally transferred 87 when possible to a central repository.” Applicant specification offers no limits on what a portable MDDS device may encompass other than that the function of receiving data may performed using a mobile phone. No support exists for serial, ethernet, or USB ports, which mobile phones generally do not have.
Executing context-aware rules, wherein the latency of rule execution is maintained below a predetermined threshold, is also not supported by Applicant specification.
Claims 2-19 are rejected by virtue of their dependency on claim 1.
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.
Claim 20 is 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 20 recites: “wherein the system is further configured to:”. It is indefinite as to which portions of the system (the one or more digital black boxes or the one or more servers) are performing the further steps of storing and processing the validated data, transmitting the records, and retrieving or polling exporting systems.
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.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process and a machine
(claims 1-20). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP §2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and /or c) mathematical concepts. MPEP §2106.04(a).
The Examiner has identified method Claim 1 and system claim 20 as the claims that represents the claimed invention for analysis.
Claim 1:
A method for collecting, storing, and making available complete and accurate medical patient data, comprising the steps of:
automatically pairing an edge-side device with one or more medical devices and associating the medical device identification with the edge-side device location within a healthcare facility, the edge-side device having serial, Ethernet, USB, and wireless communication ports;
collecting, from one or more data sources, various types of patient data at the edge-side device;
executing context-aware rules at the edge-side device in real-time based on incoming data from the paired devices, wherein the latency of rule execution is maintained below a predetermined threshold;
processing and time-synchronizing the collected various types of patient data at the edge-side device;
transmitting the processed various types of patient data to a plurality of servers over a communication network, said servers comprising exporting systems, wherein the processed various types of patient data is signed using block chain signatures;
identifying individual patients from the various types of patient data and validating the various types of patient data obtained from the edge-side device to create a set of identified and validated data, wherein the identifying and validating comprises confirming three elements of the patient data: patient identification with a code, segments of time the individual patient was on location, and patient data collected at the location;
storing and analyzing the identified and validated data to create the complete and accurate medical patient data and exporting the complete and accurate medical patient data to exporting systems; and,
polling said exporting systems for particular data segments among said identified and validated data in response to a lost data segment indication.
These above limitations under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity as managing personal behaviors. The claims are recite “collecting and transmitting various types of patient data”, “identifying individual patients”, “validating the various types of patient data”, “storing and analyzing data the identified and validated data”, and “polling… for particular data segments”, which is directed to ensuring accurate healthcare records. Ensuring accurate healthcare records is a human activity typically performed by healthcare providers, medical scribes, and other data entry specialists. It is important to note that the examples provided by the MPEP such as social activities, teaching, and following rules or instructions are provided as examples and not an exclusive listing and that 2106.04(a)(2)II states certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping.
These claims further recite: mental processes. The claims recite elements, underlined above, that can be performed in the mind of a person, with pen and paper, or using a generic computer. See also MPEP 2106.04(a)(2) III C that teaches generic computer performing an abstract idea can also fall under mental processes. These encompass collecting and transmitting data, identifying individual patients, validating the data, storing and analyzing the data, exporting data, and polling data lost data segments. Examiner notes that a healthcare professional can denote wherein data is missing ([0056] of Applicant specification, “The determination of missing or incomplete information may be done by automated processes, a healthcare professional, or both.”).
Accordingly, the claim recites at least one abstract idea.
Claim 20:
A medical data governance system, comprising:
one or more digital black boxes configured to collect and transmit patient data over a communication network; and
one or more servers configured to:
receive the patient data from the digital black boxes;
associate the received data with location and time information;
verify a data integrity signature for the patient data; and
identify individual patients and validate the data based on at least:
a coded patient identifier, time periods associated with a location, and data collected at the location;
wherein the system is further configured to:
store and process the validated data to create accurate medical patient records;
transmit the records to exporting systems; and
retrieve or poll exporting systems for missing or lost data segments.
These above limitations under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity as managing personal behaviors. The claims are recite “collecting and transmitting various types of patient data”, “identifying individual patients”, “validating the various types of patient data”, “storing and analyzing data the identified and validated data”, and “polling… for particular data segments”, which is directed to ensuring accurate healthcare records. Ensuring accurate healthcare records is a human activity typically performed by healthcare providers, medical scribes, and other data entry specialists. It is important to note that the examples provided by the MPEP such as social activities, teaching, and following rules or instructions are provided as examples and not an exclusive listing and that 2106.04(a)(2)II states certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping.
These claims further recite: mental processes. The claims recite elements, underlined above, that can be performed in the mind of a person, with pen and paper, or using a generic computer. See also MPEP 2106.04(a)(2) III C that teaches generic computer performing an abstract idea can also fall under mental processes. These encompass collecting and transmitting data, identifying individual patients, validating the data, storing and analyzing the data, exporting data, and polling data lost data segments. Examiner notes that a healthcare professional can denote wherein data is missing ([0056] of Applicant specification, “The determination of missing or incomplete information may be done by automated processes, a healthcare professional, or both.”).
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the idea into a practical application. As noted at MPEP §2106.04 (ID)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
Additional elements cited in the claims:
Edge-side device, communication ports, several servers, a communication network, block chain signatures, exporting systems (1); a medical device data system (2); positive patient identification and data validation system (3); smart phone (7); output system (8); EMR system (9); tablet (11); computer workstation (12); an Artificial Intelligent System (13); wearables (14); computing devices, a long-range, low power wireless communication protocol (15); smartwatches (17); one or more digital black boxes (20)
The Examiner notes that the independent claims teach an insignificant extra-solution activities of collecting, transmitting/exporting, simply identifying, and storing data. See also MPEP 2106.05(g).
Edge-side devices with the multitude of ports are taught at a high level of generality. The specification provides no detail on what these devices are and how they may be an improvement over other types of devices. Rather, the edge-side devices are only applied to perform the abstract idea.
Servers that would be able to perform the method are taught at a high level of generality such that the claim elements amounts to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. [0056] of Applicant specification recites: “this data is transmitted from MDG to several servers 220 which can retain the information temporarily or for prolonged periods. In accordance with the present inventive concept, all servers 220 which may have received the lost data can be polled to determine if there is a segment of data corresponding to the lost data.” No specific, technical improvements are being made to servers as they are simply being used to perform the abstract idea and the insignificant extra-solution activities of transmitting and storing data.
Communication networks and exporting systems are also taught at a high level of generality. [0058] of Applicant specification recites: “Thus, a patient with a wearable 83 and with a smartphone 200 with a Wi-Fi Halow capability can connect to any network and transmit data to MDG for storage and to the EMR.” [0052] of Applicant specification further recites: “An MDGS 163 data export subsystem with specific, recorded, and real time data in relation to location or to patient source can be configured 167, 168, 169 for output system 173, 176, 179. Internal to a MDGS export data sub-item, a backbone of all data is available 166 for export drivers 167, 168, 169 access.” No specific, technical improvements are being made to communication networks and exporting systems as any generic network or export driver may be used to perform the insignificant extra-solution activities of transmitting data.
Medical device systems are also taught at a high level of generality. [0045] of Applicant specification recites: “Binding location (geo-localization, indoor localization), time, provider, and patient are associated with data obtained from isolated or networked medical and medical relevant devices.” No specific, technical improvements are being made to medical devices as any generic medical device is utilized within the system to perform the insignificant extra-solution activity of receiving data from.
The positive patient identification and data validation system is also taught at a high level of generality. [0027] of Applicant specification recites: “As described below in more detail in the description of Fig 5, PPI and DV depends on the previous location and metadata setup of MDDS 121, 101 (Fig. 2) and proper data entry of metadata 122 or location 102, and active healthcare professional confirmation of patient location time presence 103 or the proper patient identification process 123.” No specific, technical improvements are being made to the field of data validation as a human is capable of performing the validation. Furthermore, the system is only utilized within the claims to perform the insignificant extra-solution activities of receiving and storing data.
Output systems (smart phone, EMR system, tablet, computer workstation) are also taught at a high level of generality. [0058] of Applicant specification recites: “An MDGS 163 data export subsystem with specific, recorded, and real time data in relation to location or to patient source can be configured 167, 168, 169 for output system 173, 176, 179.” No specific, technical improvements are being made to output devices as any generic device is utilized within the system to perform the insignificant extra-solution activity of exporting data to.
Artificial intelligence is also taught at a high level of generality. [0021] of Applicant specification recites: “FIG. 2 is an illustration of a simplified 3-layer MDGS in an embodiment. Artificial Intelligence and Machine Learning systems require a medical data governance middleware to assure proper, normalized and verified data inputs.” No specific, technical improvements are being made to the field of machine learning, as it is indefinite as to what the use of artificial intelligence within the claimed system is.
Wearables are also taught at a high level of generality. [0044] of Applicant specification recites: “Patient 51 might have 83 various personal wearable devices operating with BLE (blue tooth low energy or similar technologies) 84 that can be periodically or constantly in communication 85 with a fixed or portable MDDS or personal phone MDDS app 86 that has been preprogramed with a BLE MAC address to receive and associate the medical devices with the patient. Like the continuous medical measuring 59 and the measure-result laboratory systems 72, data sessions are defined 87 with metadata such as MAC, location and the receiving MDDS ID 88 and not-relevant data segments 89.” No specific, technical improvements are being made to wearable devices as any generic device is utilized within the system to perform the insignificant extra-solution activity of collecting data from.
Long-range, low-power capable computing devices (smart phones, smart watches) are also taught at a high level of generality. [0057] of Applicant specification recites: “he embodiment of Fig. 10 may also be implemented using LoRa technology. This will allow long range monitoring of sensors such as wearables 83.” No specific, technical improvements are being made to long distance communication modalities as an existing technology is simply applied to perform the insignificant extra-solution activity of transmitting data.
Block chain is also taught at a high level of generality. [0008] of Applicant specification recites: “By concentrating all available medical relevant data into a single source and providing a subset of data to each receiving subsystem with the correct source and time reference, the Medical Data Governance System becomes the true source of data and guarantees the data consistency through the use of block chain signatures.” As block chain is simply applied to the data, no specific, technical improvements are made to the technology of block chain.
The digital black boxes are taught at a high level of generality. Applicant specification does not explicitly outline what the digital black box is. They are simply applied to perform the insignificant extra-solution activities of collecting and transmitting data.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional elements as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID)(A)(2).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claim 2: This claim recites wherein a medical device data system is used to record the data; which teaches medical device data systems at a high level of generality. This claim also teaches an insignificant extra-solution activity of storing data.
Claim 3: This claim recites wherein the medical device data system provides the various types of patient data to a positive patient identification and data validation system; which teaches a positive patient identification and data validation system at a high level of generality. This claim also teaches an insignificant extra-solution activity of providing/transmitting data.
Claim 4: This claim recites wherein the positive patient identification and data validation system stores the data; which teaches a positive patient identification and data validation system at a high level of generality. This claim also teaches an insignificant extra-solution activity of storing data.
Claim 5: This claim recites wherein said various types of patient data are timestamped; which teaches an abstract idea of mental processes, such as timestamping data.
Claim 6: This claim recites wherein said various types of patient data are associated with a location; which teaches an abstract idea of mental processes, such as associating data with a location.
Claim 7: This claim recites wherein said complete and accurate medical patient data is exported to a smart phone; which teaches smart phones at a high level of generality. This claim also teaches an insignificant extra-solution activity of exporting/transmitting data.
Claim 8: This claim recites wherein said exported patient data is configured according to a receiving output system; which teaches receiving output systems at a high level of generality. This claim also teaches an insignificant extra-solution activity of exporting/transmitting data.
Claim 9: This claim recites wherein said receiving output system is an EMR system; which teaches EMR systems at a high level of generality.
Claim 10: This claim recites wherein said receiving output system is a smart phone; which teaches smart phones at a high level of generality.
Claim 11: This claim recites wherein said receiving output system is a tablet; which teaches tablets at a high level of generality.
Claim 12: This claim recites wherein said receiving output system is a computer workstation; which teaches computer workstations at a high level of generality.
Claim 13: This claim recites wherein the destination system is part of or entirely of an Artificial Intelligent or Expert System; which teaches an abstract idea of certain methods of organizing human activity, as expert systems rely on the input/personal behaviors of human experts. This claim further teaches artificial intelligence at a high level of generality.
Claim 14: This claim recites wherein one of the various types of patient data are data generated from wearables associated with a particular medical data device system, and wherein said particular medical data device system polls said wearables to retrieve any missing data in response to a temporary disconnection; which teaches an insignificant extra-solution activity of selecting a data source or type for manipulation.
Claim 15: This claim recites including the steps of downloading a software application to computing devices capable of operating using a long-range, low-power wireless communication protocol; pairing one of the wearables to one of the computing devices; connecting the paired computing devices to said communications network for transmission of medical device data thereto; whereby said communications network is extended outside of a medical facility; which teaches which teaches downloading an application, pairing, and connecting computing devices capable of operating using a long-range, low-power wireless communication protocol at a high level of generality, as generic devices are used to perform the insignificant extra-solution activity of transmitting data.
Claim 16: This claim recites wherein each of said wearables is associated with a specific patient; which teaches an abstract idea certain methods of organizing human activity by associating a device with a person.
Claim 17: This claim recites wherein the computing devices are smartphones or smartwatches; which only serves to limit the type computing device. Smartphones and smartwatches are taught at a high level of generality.
Claim 18: This claim recites wherein the devices are in transport; which teaches wherein the devices are capable of being moved, which is obvious in light of claim 17, which defines such devices as smartphones and smartwatches.
Claim 19: This claim recites wherein the computing devices are positioned at a location remote from said medical facility; which limits where the computing devices may be located.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
These claims 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, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
Amount to elements that have been recognized as activities in particular fields (such as Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), MPEP §2106.05(d)(II)(i);storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv)).
Regarding claim 14, this claim teaches retrieving missing data in response to a temporary disconnection, which is known within the art, as evidenced by [0180] of Fuchs (US 20240008777), which recites: “the mobile application may request data from the analyte monitoring device (e.g., if the mobile application identifies gaps in the data it has collected, such as due to disconnections).”
Further evidence is provided by Kumar (US 20210378601), which recites: [0096], “At Step 604, a disconnection event or condition occurs that causes an interruption to the communication link between the first device and the second device.” [0097], “At Step 606, the communication link is re-established between the first device and the second device (e.g., the first device comes back into the wireless communication range of the second device). Upon reconnection, the second device requests historical analyte data according to a last lifecount metric for which data was received.” [0099], “the requested historical analyte data can be used to fill in gaps in a glucose trend graph by displaying the requested historical analyte data along with previously received analyte data.”
Dependent claims 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. Dependent claims recite additional subject matter which amount to limitations consistent additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-19 additional limitations which amount to elements that have been recognized as activities in particular fields, claims 2-19, e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii); claims 2-19, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv). 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.
Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Murrish (US 20200251225) in view of White (US 20210304881) further in view of Liang (Liang; Xueping, Integrating blockchain for data sharing and collaboration in mobile healthcare applications, 2017, IEEE).
Regarding claim 1, Murrish teaches a method for collecting, storing, and making available complete and accurate medical patient data, comprising the steps of:
collecting, from one or more data sources, various types of patient data at the edge-side device ([0005], “raw data is received from a plurality of data collectors, where the plurality of data collectors extract raw data from a plurality of raw data sources. In one aspect, the plurality of data collectors comprise electronic medical records crawlers, clinical and administrative data collectors, claims data collectors, document feed collectors and medical device feed collectors.” [0028], “Computing system 1030 may be embodied as a distributed computing system, a centralized computing system, a single computer such as a desktop or laptop computer or a networked computing system, described in other embodiments herein.”). Examiner interprets the edge-side device to be a desktop computer, as desktop computers typically have serial, ethernet, USB, and wireless communication ports.
executing context-aware rules at the edge-side device in real-time based on incoming data from the paired devices, wherein the latency of rule execution is maintained below a predetermined threshold ([0039], “multi-agent system 1030 facilitates receiving health information from disparate sources (or crawl disparate sources of health information), such as EHR systems, Health Information Exchanges (HIE)s, claims information, emergency medical records, doctor notes, patient-provided information (such as patient surveys), patient monitors and lab results, or any other source of patient health-related information); indexing the received information, mapping concepts in the received information such as performing synonymic matching and ontology mapping;”). Under the broadest reasonable interpretation, Examiner interprets indexing the received patient data to encompass a context-aware rule, as a rule may be to index information that is received. Furthermore, successful indexing of information may encompass maintaining the latency of the execution of the indexing rule below a threshold, as the indexing is performed.
processing the collected various types of patient data at the edge-side device ([0021], “the plurality of raw data sources may comprise electronic medical records, personal health records, images, documents, and medical devices. The raw data is sorted into unstructured raw data, structured data of non-standard nomenclature, and structured data of standard nomenclature. The raw data is then transformed into relevant data through the use of natural language processing, nomenclature and ontology mapping, and distributed adaptive knowledge processing.” [0028], “Computing system 1030 may be embodied as a distributed computing system, a centralized computing system, a single computer such as a desktop or laptop computer or a networked computing system, described in other embodiments herein.”);
transmitting the processed various types of patient data to a plurality of servers over a communication network, said servers comprising exporting systems ([0028], “The control server 102 might operate in a computer network 106 using logical connections to one or more remote computers 108. Remote computers 108 might be located at a variety of locations in a medical or research environment, including clinical laboratories (e.g., molecular diagnostic laboratories), hospitals and other inpatient settings, veterinary environments, ambulatory settings, medical billing and financial offices, hospital administration settings, home healthcare environments, and providers' offices.” [0066], “the cloud-computing platform 162 can communicate internally through connections dynamically made between the virtual machines and computing devices and externally through a physical network topology to resources of a remote network such as with medical organizations 156, 158, and 160.”);
identifying individual patients from the various types of patient data and validating the various types of patient data obtained from the edge-side device to create a set of identified and validated data ([0070], “manager 152 is available in the cloud-computing platform 162 in a manner that enables the cross-venue recognition of a patient through the use of a patient identity management component 164 such as an electronic Master Person Index (MPI or EMPI). Patient identity management component 164 allows manager 152 to match data for the same patient that originates with different medical organizations… FIGS. 8A, 8B, and 8C, in some embodiments management component 164 facilitates record linkage (MPI) functions such as those performed at step 845 in the method provided in FIG. 8A.” [0132], “some of these embodiments then utilize the discovered latent semantic structures to establish linkages between terms extant on the multiple systems or to validate linkages that have been established in other ways, either by manual human effort or by other algorithmic means.” [0019], “the data is transformed into a dataset (referred to as “one record”) which includes data and or pointers to data about a particular patient, from available data sources.”),
wherein the identifying and validating comprises confirming two elements of the patient data: patient identification with a code and patient data collected at the location ([0075], “Electronic clinical documents contain various types of information relevant to the condition and/or treatment of a particular patient and can include information relating to, for example, patient identification information, images, physical examinations, vital signs, past medical histories, surgical histories, family histories, histories of present illnesses, current and past medications, allergies, symptoms, past orders, completed orders, pending orders, tasks, lab results, other test results, patient encounters and/or visits, immunizations, physician comments, nurse comments, other caretaker comments, and a host of other relevant clinical information. Images may comprise radiographic images, graphs, pictures, photographs, tables, and the like.”). Examiner notes that under the broadest reasonable interpretation, patient identification with a code would be encompassed by patient identification information.
storing and analyzing the identified and validated data to create the complete and accurate medical patient data and exporting the complete and accurate medical patient data to exporting systems ([0019], “linking patient records for the same patient; reconciling the health information, and storing it in a “one-record” standardized data structure, where it can be accessible for services and studies” [0028], “a remote computer 108 is associated with a health records, data source such as an electronic health record (EHR) system of a hospital or medical organization (such as medical organization 156 of FIG. 1B), a health information exchange EHR, insurance provider EHR, ambulatory clinic EHR, or patient-sensor, or other data source, and facilitates accessing data of the source and communicating the data to control server 102 and/or other computing devices on a cloud computing platform, including other remote computers 108.”); and,
polling said exporting systems for particular data segments among said identified and validated data in response to a lost data segment indication ([0138], “At a step 847, the information is reconciled. In some embodiments, reconciliation includes eliminating duplicative information; cleansing the information (such as removing outliers; for example, a patient's temperature of 1000 degrees); filling in holes in patient information throug