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 .
Claims Status
Claims 1, 9, 11, 20 filed 06/10/2026 have been amended.Claims 1-20 are pending and have been rejected.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive. Applicant asserts that cited references fail to disclose or suggest a UDI identifying the medical device "as a Host ID assigned to the medical device by a registry function of a digital healthcare platform," where the Host ID "permit[s] the medical device to communicate on the digital healthcare platform." Furthermore, cited references alone or in combination do not disclose or suggest, at least, "authenticate the user as an authorized user of the medical device based on the UDI and the UUI," where "the authentication is performed locally at the device level prior to data collection and data transmission," or "prior to successful authentication of the user, prevent the sensor from collecting physiological data." Also, cited references, alone or in combination, do not teach or suggest, "upon successful authentication," collecting physiological data using the sensor and, "before the medical device sends the collected physiological data," formulating "a data frame comprising a message stack with: (i) collected physiological data, (ii) UUI, and (iii) UDI," where "the message stack enhances the collected physiological data with context information that identifies both the specific user and the specific medical device at time of collection." However, the Examiner respectfully disagrees as Lamego et al. (U.S. Publication 2015/0073241) in paragraph 0031-0033, shows a user has registered their medical device(s) to their user account on the medical device management system, the user can have access to medical data collected by their medical device. The identification information associated with a user device, wherein the identification information can include information such as device ID (e.g., serial number) (unique device identifier) that can be used by the medical device management system. Paragraphs 0033, shows authentication needs to be provided in order to access data. Paragraphs 0032-0036, shows once medical device is authenticated, it is registered, wherein physiological data can be retrieved from the medical device and send it to the medical device management system. The interface module of medical device can retrieve identification information or data. A person skilled in the art would reasonably recognize that in order to receive any information, a user needs to be first logged in. Paragraph 0038, the medical device management system can create a reference file (e.g., XML file), referencing the new physiological data and invoking the algorithm processing module, wherein the reference file can provide the information necessary to access the physiological information, run the required algorithm, calculate the results (or return an error code if unable to generate a result), and then create the desired output file. The output file can include information such as measured parameters, processing time, errors that can have occurred, algorithm version, and timestamp. Applicant asserts that the cited references do not teach or suggest "transmitting the encrypted data frame as a bit stream, via an encrypted channel, to a coordination gateway of the digital healthcare platform at a remote location" as recited in amended claim 1. However, the Examiner respectfully disagrees as Guim Bernat (U.S. Publication 2020/0213280) in paragraph 0040, shows anonymizer manages receipt of registration commands and keys (e.g., using registration manager and key manager) and loads registered bitstreams from anonymization configuration to configure accelerator circuitry such as one or more of FPGAs and/or AI cores, based at least in part on tenant IDs of packets, packet flow types, and associated masks.
As it is Applicant's right to claim as broadly as possible their invention, it is also the Examiner's right to interpret the claim language as broadly as possible. It is the Examiner's position that the detailed functionality that allows for Applicant's invention to overcome the prior art used in the rejection, fails to differentiate in detail how these features are unique. It is clear that Applicant must be able to submit claim language to distinguish over the prior arts used in the above rejection sections that discloses distinctive features of Applicant's claimed invention. It is suggested that Applicant compare the original specification and claim language with the cited prior art used in the rejection section above or the remark section below to draw an amended claim set to further the prosecution.
Failure for Applicant to narrow the definition/scope of the claims and supply arguments commensurate in scope with the claims implies the Applicant's intent to broaden claimed invention.
Based on the rationale explained above, the Examiner disagrees with the prior arts being silent to the claimed embodiment.
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.
Claims 1-9, 11-18 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lamego et al. (U.S. Publication 2015/0073241), hereinafter “Lamego” in view of Shaya et al. (U.S. Publication 2012/0029303), hereinafter “Shaya” and Guim Bernat (U.S. Publication 2020/0213280), hereinafter “Guim Bernat”.
As to claims 1 & 11, Lamego discloses a medical device comprising: a sensor configured to collect physiological data (Lamego, see [0055], sensor of medical device can gather physiological data); an authentication engine, the authentication engine configured to (Lamego, see [0033], authentication of medical device): receive a unique device identifier (UDI), the UDI uniquely identifying the medical device as a Host ID assigned to the medical device by a registry function of a digital healthcare platform, the Host ID uniquely identifying the medical device and permitting the medical device to communicate of the digital healthcare platform (Lamego, see [0031-0033], a user has registered their medical device(s) to their user account on the medical device management system, the user can have access to medical data collected by their medical device. The identification information associated with a user device, wherein the identification information can include information such as device ID (e.g., serial number) that can be used by the medical device management system); receive a unique user identifier (UUI), the UUI uniquely identifying a user of the medical device (Lamego, see [0032-0033], identification information associated with a user account, wherein the identification information can include information such as user ID); authenticate the user as an authorized user of the medical device based on the UDI and the UUI, wherein the authentication is performed locally at the device level prior to data collection and data transmission (Lamego, see [0033], authentication token can be provided to the medical device, which can be stored on the device for authentication and identification purposes); prior to successful authentication of the user, prevent the sensor from collecting physiological data (Lamego, see [0033], authentication needs to be provided in order to access data); and upon successful authentication, collect physiological data using the sensor and, before the medical device sends the collected physiological data, formulate a data frame comprising a message stack with: (i) collected physiological data, (ii) UUI, and (iii) UDI, wherein the message stack enhances the collected physiological data with context information that identifies both the specific user and the specific medical device at the time of collection (Lamego, see [0032-0036], once medical device is authenticated, it is registered, wherein physiological data can be retrieved from the medical device and send it to the medical device management system. The interface module of medical device can retrieve identification information or data such as, user credentials, device ID (e.g., serial number), and/or other required and/or relevant information from the device. See [0038], the medical device management system can create a reference file (e.g., XML file), referencing the new physiological data and invoking the algorithm processing module, wherein the reference file can provide the information necessary to access the physiological information, run the required algorithm, calculate the results (or return an error code if unable to generate a result), and then create the desired output file. The output file can include information such as measured parameters, processing time, errors that can have occurred, algorithm version, and timestamp); Lamego is silent to an encryption engine encrypting the data frame via an encryption algorithm; and a transmission component transmitting the encrypted data frame as a bit stream, via an encrypted channel, to a coordination gateway of the digital healthcare platform at a remote location. However, Shaya discloses an encryption engine encrypting the data frame via an encryption algorithm (Shaya, see [0058], patient device encrypts patient diagnostic information and information identifying the patient (hereinafter patient identification data) using an encryption protocol); and Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lamego in view of Shaya in order to further modify the method for calibrating medical devices and processing physiological measurements using a medical device management system from the teachings of Lamego with the method for permitting a real-time virtual medical examination using a patient device from the teachings of Shaya. One of ordinary skill in the art would have been motivated because it would allow performing virtual medical examinations using secure videoconferencing and the secure transmission and receipt of patient diagnostic information (Shaya – 0002). Lamego in view of Shaya is silent to a transmission component transmitting the encrypted data frame as a bit stream, via an encrypted channel, to a coordination gateway of the digital healthcare platform at a remote location. However, Guim Bernat discloses a transmission component transmitting the encrypted data frame as a bit stream, via an encrypted channel, to a coordination gateway of the digital healthcare platform at a remote location (Guim Bernat, see [0015], [0030] & [0038], packets are transmitted, wherein the packet includes identifying information about a patient for use in a medical application. Packet includes identifying information about a patient for use in a medical application, such as MSG_Payload={UserID INT8, Temperature INT64, HeartRate INT64}, where UserID uniquely identifies a patient in the form of a bitstream, wherein anonymizes the packet by removing the unique patient information. Bitstream can also anonymize the packet by removing geographic location information. See [0040], anonymizer manages receipt of registration commands and keys (e.g., using registration manager and key manager) and loads registered bitstreams from anonymization configuration to configure accelerator circuitry such as one or more of FPGAs and/or AI cores, based at least in part on tenant IDs of packets, packet flow types, and associated masks.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lamego in view of Shaya and Guim Bernat in order to further modify the method for calibrating medical devices and processing physiological measurements using a medical device management system from the teachings of Lamego with the method for permitting a real-time virtual medical examination using a patient device from the teachings of Shaya and the method of processing of packets in a computing system from the teachings of Guim Bernat. One of ordinary skill in the art would have been motivated because it would allow anonymize the packet data by converting it to bitstream (Guim Bernat – 0002).
As to claims 2 & 12, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claims 1 & 11. Lamego further discloses wherein the medical device is any of the following: a blood pressure monitor, glucometer, oximeter, spirometer, oxygen nebulizer, stethoscope, electrocardiogram (ECG) device, thermometer, activity tracker, or weighing scale (Lamego, see [0040], medical device is a handheld glucometer).
As to claims 3 & 13, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claims 1 & 11. Shaya further discloses wherein the UDI is hardcoded or encoded through Subscriber Identity Module (SIM) or embedded Subscriber Identity Module (eSIM) type programmable technology (Shaya, see [0032], physician device is a handheld device includes a subscriber identity module (SIM) card).
As to claim 4, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claim 1. Lamego further discloses wherein the UDI is information associated with hardware of the medical device (Lamego, see [0032-0033], identification information associated with a user device, wherein the identification information can include information such as device ID (e.g., serial number)).
As to claims 5 & 14, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claims 4 & 11. Lamego further discloses wherein the information associated with hardware is any of the following: a model number of the medical device or a serial number of the medical device (Lamego, see [0032-0033], identification information associated with a user device, wherein the identification information can include information such as device ID (e.g., serial number)).
As to claims 6 & 15, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claims 1 & 11. Lamego further discloses wherein the UDI is information associated with a software configuration of the medical device (Lamego, see [0027], the application can be configured to recognize the medical device).
As to claims 8 & 17, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claims 1 & 11. Lamego further discloses wherein the data frame further comprises any of, or a combination of, the following information: date, time, location information, and environmental information (Lamego, see [0036], data sent from medical device created a file with information with the physiological data, wherein the file includes a timestamp, a location of a binary file (raw physiological data), and location that an output file should be stored).
As to claims 9 & 18, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claims 1 & 11. Lamego further discloses wherein receiving, from a personal device associated with the user, virtual persona authentication information, the virtual persona authentication information comprising an aggregation of features including unique identifying information of a plurality of devices determined to be proximate to the personal device (Lamego, see [0032-0033], receiving user credentials can provide authentication to the medical device); and determining, based on the virtual persona authentication information, that a confidence metric satisfies a threshold (Lamego, see [0032-0034], receiving user credentials can provide authentication to the medical device, wherein the medical device management system can be configured to allow multiple users to use the same medical device).
As to claim 20, Lamego discloses an article of manufacture comprising non-transitory computer storage medium storing computer readable program code which, when executed by a computer, implements a method as implemented in a medical device, the medium comprising: computer readable program code collecting physiological data (Lamego, see [0055], sensor of medical device can gather physiological data); computer readable program code receiving a unique device identifier (UDI), the UDI uniquely identifying the medical device and assigned to the medical device by a registry function of a digital healthcare platform (Lamego, see [0032-0033], identification information associated with a user device, wherein the identification information can include information such as device ID (e.g., serial number) that can be used by the medical device management system); computer readable program code receiving a unique user identifier (UUI), the UUI uniquely identifying a user of the medical device (Lamego, see [0032-0033], identification information associated with a user account, wherein the identification information can include information such as user ID); computer readable code controlling operation of a sensor such that physiological data is not collected prior to successfully authentication of the user (Lamego, see [0033], authentication needs to be provided in order to access data); computer readable program code authenticating the user as an authorized user of the medical device based on the UDI and the UUI (Lamego, see [0033], authentication token can be provided to the medical device, which can be stored on the device for authentication and identification purposes); computer readable program code, upon successful authentication, formulating a data frame with: (1) collected physiological data, (2) UUI, and (3) UDI (Lamego, see [0032-0036], once medical device is authenticated, it is registered, wherein physiological data can be retrieved from the medical device and send it to the medical device management system. The interface module of medical device can retrieve identification information or data such as, user credentials, device ID (e.g., serial number), and/or other required and/or relevant information from the device); Lamego is silent to computer readable program code encrypting the data frame via an encryption algorithm; and transmitting the encrypted data frame as a bit stream. However, Shaya discloses computer readable program code encrypting the data frame via an encryption algorithm (Shaya, see [0058], patient device encrypts patient diagnostic information and information identifying the patient (hereinafter patient identification data) using an encryption protocol); and Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lamego in view of Shaya in order to further modify the method for calibrating medical devices and processing physiological measurements using a medical device management system from the teachings of Lamego with the method for permitting a real-time virtual medical examination using a patient device from the teachings of Shaya. One of ordinary skill in the art would have been motivated because it would allow performing virtual medical examinations using secure videoconferencing and the secure transmission and receipt of patient diagnostic information (Shaya – 0002). Lamego in view of Shaya is silent to transmitting the encrypted data frame. However, Guim Bernat discloses Lamego in view of Shaya is silent to transmitting the encrypted data frame (Guim Bernat, see [0015], [0030] & [0038], packets are transmitted, wherein the packet includes identifying information about a patient for use in a medical application. Packet includes identifying information about a patient for use in a medical application, such as MSG_Payload={UserID INT8, Temperature INT64, HeartRate INT64}, where UserID uniquely identifies a patient in the form of a bitstream, wherein anonymizes the packet by removing the unique patient information. Bitstream can also anonymize the packet by removing geographic location information). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lamego in view of Shaya and Guim Bernat in order to further modify the method for calibrating medical devices and processing physiological measurements using a medical device management system from the teachings of Lamego with the method for permitting a real-time virtual medical examination using a patient device from the teachings of Shaya and the method of processing of packets in a computing system from the teachings of Guim Bernat. One of ordinary skill in the art would have been motivated because it would allow anonymize the packet data by converting it to bitstream (Guim Bernat – 0002).
Claims 10 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lamego et al. (U.S. Publication 2015/0073241), hereinafter “Lamego” in view of Shaya et al. (U.S. Publication 2012/0029303), hereinafter “Shaya”, Guim Bernat (U.S. Publication 2020/0213280), hereinafter “Guim Bernat” and Nikander (U.S. Publication 2008/0195865), hereinafter “Nikander”.
As to claims 10 & 19, Lamego in view Shaya and Guim Bernat discloses everything disclosed in claims 1 & 11, but is silent to wherein the encryption algorithm is any of the following: Elliptic-curve Diffie-Hellman (ECDH), Edwards Elliptic Curve Digital Signature Algorithm (EdDSA) used in Host Identities (HI) and for Base Exchange (BEX) signatures, hashes used in Host Identity Tag (HIT) generation, keyed hashes used for KEYMAT (Keying Material) generation and packet MACing (Message Authentication Code) operations, and Authenticated Encryption with Associated Data (AEAD) and stream ciphers to use in Host Identify Protocol (HIP) and HIP enabled secure communication protocols. However, Nikander discloses wherein the encryption algorithm is any of the following: Elliptic-curve Diffie-Hellman (ECDH), Edwards Elliptic Curve Digital Signature Algorithm (EdDSA) used in Host Identities (HI) and for Base Exchange (BEX) signatures, hashes used in Host Identity Tag (HIT) generation, keyed hashes used for KEYMAT (Keying Material) generation and packet MACing (Message Authentication Code) operations, and Authenticated Encryption with Associated Data (AEAD) and stream ciphers to use in Host Identify Protocol (HIP) and HIP enabled secure communication protocols (Nikander, see [0019], Host Identity public key PK.sub.I, encrypted using a session key constructed with the Responder's public Diffie-Helhnan key). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lamego in view of Shaya, Guim Bernat & Nikander in order to further modify the method for calibrating medical devices and processing physiological measurements using a medical device management system from the teachings of Lamego with the method for permitting a real-time virtual medical examination using a patient device from the teachings of Shaya with the method of processing of packets in a computing system from the teachings of Guim Bernat and the method for Host Identify Protocol from the teachings of Nikander. One of ordinary skill in the art would have been motivated because it would allow separation in order to handle mobility and multi-homing in a secure way (Nikander – 0007-0008).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TANIA M PENA-SANTANA whose telephone number is (571)270-0627. The examiner can normally be reached Monday - Friday 8am to 4pm EST.
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/TANIA M PENA-SANTANA/Examiner, Art Unit 2443
/NICHOLAS R TAYLOR/Supervisory Patent Examiner, Art Unit 2443
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