DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Amendments
Claims 1-20 are currently pending in this case and have been examined and
addressed below. This communication is a Final Rejection in response to the
Amendment to the Claims and Remarks filed on 09/08/2025.
Claims 1, 5-6, 11, and 14-15 are amended claims.
Claims 2, 12-13, 16 are original claims.
Claims 3-4, 7-10, and 17-20 are previously presented.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/22/2025, 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. an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1-20 are drawn to a method and a system, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a method comprising after a reusable medical [tool] is used during a first medical procedure, reprocessing the reusable medical [tool] using a first reprocessing procedure; identifying the reusable medical [tool] for use in a second medical procedure; before using the reusable medical [tool] in a second medical procedure: obtaining first reprocessing data of the reusable medical device; scanning, a tag attached to the reusable medical [tool], wherein the tag identifies the reusable medical device; querying for procedure details and the procedure classification of the second medical procedure; automatically analyzing the first reprocessing data and the procedure details and the procedure classification of the second medical procedure relative to at least one hygiene standard; based on the analyzing of the first reprocessing data and the procedure details and the procedure classification of the second medical procedure relative to the at least one hygiene standard, wherein the alert indicating indicates noncompliance with the at least one of hygiene standards standard; updating, based on the alert, a [tool] status corresponding to the tag, wherein the updating includes providing an indication that the reusable medical device is withdrawn from service.
Independent claim 11 recites a system comprising upload reprocessing data, the reprocessing data relating to a reprocessing procedure of the environment or the [tool] after a first procedure is performed; query for procedure details and the procedure classification of a second procedure before the second procedure is performed; transmit instructions based on the procedure details and the procedure classification of the second procedure; upload second procedure data of a second procedure involving the environment or the [tool], wherein based on comparing procedure details, the procedure classification, and the second procedure data of the second procedure and the reprocessing data with a plurality of hygiene standards, the alert indicating noncompliance with at least one of the plurality of hygiene standards.
These steps amount to certain methods of organizing human activity which includes functions relating to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
The claims recite the additional elements of a reusable medical device, a graphical user interface of a scanning device, a scanning device, a centralized database, a central application, one or more mobile devices, and a network.
These elements are recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application.
Claims 1 and 11 recite automatically transmitting an alert. These limitations are recited as a tool which only serves as extra solution activities incidental to the primary process that is merely a nominal or tangential addition to the claim (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
As discussed above with respect to integration of the abstract idea into a practical application, the claims recite the additional elements of a reusable medical device, a graphical user interface of a scanning device, a scanning device, a centralized database, a central application, one or more mobile devices, and a network.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
The courts have decided that receiving or transmitting data over a network as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example i. receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network).
For the reasons stated, these claims fail to amount to significantly more and are consequently rejected under 35 U.S.C. § 101.
Analysis of Dependent Claims
Dependent claims 2 and 13 recite determining at least one other medical procedure performed using the reusable medical device and generating an alert identifying at least one other medical procedure as having a risk of cross- contamination.
Dependent claim 4 recites comprising analyzing past medical procedure and reprocessing data of a plurality of reusable medical devices to determine a reprocessing compliance baseline, the reprocessing compliance baseline comprising historical compliance levels of one or more standards, and generating alerts based on determining that future medical procedure and reprocessing data of the plurality of reusable medical devices deviate from the historical compliance levels.
Dependent claims 5 and 14 recite analyzing governing laws, standards, guidelines and instructions for use of reusable medical devices to determine a reprocessing compliance baseline.
Dependent claim 6 recites wherein the reprocessing further comprises a reprocessing device automatically uploading the first reprocessing data, wherein the at least one hygiene standard is extracted from governing laws, standards, guidelines, or instructions associated with the procedure classification, and wherein the procedure classification provides an indication of a type of skin contact associated with the second medical procedure.
Dependent claim 7 recites wherein the reprocessing further comprises automatically uploading the first reprocessing data.
Dependent claim 8 recites wherein performing the first medical procedure further comprises uploading the first medical procedure data.
Dependent claim 9 recites at the scanning device, automatically analyzing first medical procedure data, wherein the first medical procedure data comprises first patient data; determining a risk to a second patient of a second patient data from a first patient of the first patient data due to a cross-contamination.
Dependent claim 15 recites the central application automatically receives second procedure data, wherein the at least one hygiene standard is extracted from governing laws, standards, guidelines, or instructions associated with the procedure classification, and wherein the procedure classification provides an indication of a type of skin contact associated with the second medical procedure.
Dependent claim 16 recites the central application correlates historical procedure data to determine persons exposed to a hygiene risk by the noncompliance with the at least one of the plurality of hygiene standards.
Dependent claim 17 recites reprocessing, based on the alert, the reusable medical device using a second reprocessing procedure; determining the second reprocessing procedure is in compliance with the at least one hygiene standard; and placing, the reusable medical device, into service in response to determining the second reprocessing procedure is in compliance with the at least one hygiene standard.
Dependent claim 18 recites wherein the second reprocessing procedure is determined based on the procedure details of the second medical procedure.
Dependent claim 20 recites wherein the reprocessing data includes a disinfection status or sterilization status of the environment or the device after a first reprocessing procedure of the environment or the device is performed.
Each of these steps of the preceding dependent claims 2, 4-9, 13-18, and 20 only serve to further limit or specify the features of independent claims 1 or 11 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
Dependent claim 3 recites wherein one or more mobile devices are used for uploading the first reprocessing data and the procedure details of the second medical procedure to a central application, and the central application or the one or more mobile devices automatically generate the alert. The specification recites: “a mobile electronic device that is able to connect to a network using direct connection, Wi-Fi or telecommunications (e.g., 4G, etc.) to send reusable medical device unique identification information, reusable medical device reprocessing information from a high level disinfection reprocessing device, reusable medical device usage information, patient and/or procedure identification information and time and date information to a centralized application that aggregates, processes and presents back evidence based track and traceability information related to the hygiene practices of reusable medical devices, including notifications of hygiene activities that present risk to patient/s as indicated by governing laws, standards, guidelines and product Instructions for Use (IFUs)” (Para. 0039). The specification and the instant claim do not provide any indication that the mobile user device or central application as being utilized beyond their ordinary capacity. Therefore, this step is directed to invoking a device merely as a tool to perform an existing process and does not integrate a judicial exception into a practical application or provide significantly more (MPEP 2106.05(f)(2)).
Dependent claim 10 recites wherein the plurality of reusable medical devices comprises mobile reusable medical devices. The mobile reusable medical devices are additional elements, which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
Dependent claim 12 recites wherein the environment comprises an emergency vehicle. The emergency vehicle are additional elements, which is mere instructions to apply the exception and does not provide a practical application or significantly more for the same reasons.
Dependent claim 19 recites wherein the graphical user interface is configured to obtain the procedure details of the second procedure from a user before the second procedure is performed by the user. The specification recites: “the mobile application 104 will provide a user interface that allows healthcare personnel to capture details of the reusable medical device, procedure, patient and accession number at the point of care, etc.” (Para. 0035).The specification and the instant claim do not provide any indication that the graphical user interface is being utilized beyond its ordinary capacity. Therefore, this step is directed to invoking a device merely as a tool to perform an existing process and does not integrate a judicial exception into a practical application or provide significantly more (MPEP 2106.05(f)(2)).
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.
Claim(s) 1-4, 7-10, 17-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart (US 20170091398 A1) in view of Nesterenko (US 20210059784 A1)..
As per Claim 1, Karumba teaches a method for reusable medical device reprocessing compliance management, the method comprising:
after a reusable medical device is used during a first medical procedure, reprocessing the reusable medical device using a first reprocessing procedure;( [Para. 0001] use of medical instruments with a first patient, followed by reuse with a second patient, has the potential to result in disease transmission from the first patient to the second patient (e.g., assuming the first patient has a transmissible disease) if such instruments are not properly sterilized between procedures. [Para. 0039] Surgical instrument transactions may include, but not be limited to: registering an instrument, updating the status of the instrument, storing the usage information of the instrument, repairing information, test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.), etc. [Para. 0040] All of the above data representing ID, location, use (as well as other data) with respect to a given surgical item is considered transaction data. Such transaction data is what is provided to any given computing node 204-1, 204-2, 204-3, 204-4, . . . , 204-N (from data source 202 or some other computing node) for use in computing a blockchain, for example, as described above in the context of FIG. 1. The transaction data controller 210 is configured to receive or otherwise obtain the transaction data for each computing node, while the blockchain controller 212 is configured to compute the blockchain for each computing node. [Para. 0041] FIG. 3A illustrates a temporal life span 300 (T.sub.0 through T.sub.M) of a surgical item (surgical instrument, in this example) with the various transaction data sets 302 through 308 that may be tracked during that time period.)
identifying the reusable medical device for use in a second medical procedure;
([Para. 0043] Instrument use data set 304: When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc. Before an instrument is used in a procedure, risk assessment controller 214 queries the instrument history (e.g., from past transaction data in the blockchain) and assesses the likelihood of use in the current procedure and may also give recommendations (e.g., use the tool, do not use the tool, use the tool but with certain precautions, etc.).)
before using the reusable medical device in a second medical procedure:
obtaining, via a graphical user interface of a scanning device, first reprocessing data of the reusable medical device; ([Para. 0039] Surgical instrument transactions may include, but not be limited to: storing the usage information of the instrument and test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.), etc. [Para. 0040] All of the above data representing ID, location, use (as well as other data) with respect to a given surgical item is considered transaction data. Such transaction data is what is provided to any given computing node (from data source 202 or some other computing node) for use in computing a blockchain, for example, as described above in the context of FIG. 1The transaction data controller 210 is configured to receive or otherwise obtain the transaction data for each computing node, while the blockchain controller 212 is configured to compute the blockchain for each computing node. [Para. 0041] FIG. 3A illustrates a temporal life span 300 (T.sub.0 through T.sub.M) of a surgical item (surgical instrument, in this example) with the various transaction data sets 302 through 308 that may be tracked during that time period. [Para. 0042] RFID scanners (i.e. scanning device) may be used to capture such identification data. These identification capture devices are considered part of the transaction data controller 210.)
scanning, with the scanning device, a tag attached to the reusable medical device, wherein the tag identifies the reusable medical device; ([Para. 0042] RFID scanners (i.e. scanning device) may be used to capture such identification data. These identification capture devices are considered part of the transaction data controller 210. [Para. 0032] To provide identification for tracking surgical tools, radio frequency identification (RFID) tags may be employed.)
Karumba does not explicitly teaches, however Smart teaches
querying, via the graphical user interface of the scanning device, for procedure details and the procedure classification of the second medical procedure; ([Para. 0052] The master station 100 programs the tag 20 and operator tag 30. In particular, the master station 100 programs the tag 20 with information including i) a Unique Identification Number (UID); ii) the type of scope 10; iii) the name of the scope 10; iv) the amount of time the scope 10 is allowed outside of a clean storage environment once it has been cleaned; and v) the length of time the scope 10 can be stored in the clean storage environment. [Para. 0056] The process modules 220 monitor operator workflow associated with the scope 10 before proceeding to an automatic cleaning unit associated with the cleaning module 240. [Para. 0064-0065] The third process module 220c allows the operator to register that the scope 10 has been manually washed and rinsed (according to guidelines). Examiner interprets the use of automatic/ automated vs. manual washing procedures to be indicative of procedure classification. The process module 220c is configured to record on the tag 20 that the scope 10 has been manually washed and rinsed after the operator swipes their operator tag 30 proximate to the third process module 220c followed by the tag 20. [Para. 0073] The cleaning module 240 records the cleaning of the scope 10 in an associated cleaning unit. For example, the cleaning module 240 records whether a short, standard or long wash has been used to clean the scope 10 in the associated cleaning unit. Furthermore, other parameters such as whether alcohol was used in the clean cycle are recorded. In this regard, the cleaning module 240 is configured to receive a validity indication from the associated cleaning unit that the scope 10 has been cleaned according to a particular wash cycle. [Para. 0109] The system monitor 500 can be used to query the current status of the scope 10. It may also provide a summary of the recent or current activity at the cleaning unit via the cleaning module 240 and the history of the clean storage cabinet via the storage controller 400.)
at the scanning device, automatically analyzing the first reprocessing data and the procedure details and the procedure classification of the second medical procedure relative to at least one hygiene standard; ([Para. 0077] The status device 300 is also configured to assist in determining cross-contamination. That is, if the status device 300 detects, via the tag 20, that the scope 10 has not been processed correctly through the process modules 220 or a validity indication has not been received from the cleaning unit and/or the cleaning module 240 (i.e. analysis of procedure classification relative to at least one hygiene standard), the status device 300 is configured to indicate that other scopes adjacent thereto have been contaminated. For example, the LED displays may indicate that the scope 10 and the scopes adjacent thereto must be re-cleaned.)
automatically transmitting, with the scanning device, an alert based on the analyzing of the first reprocessing data and the procedure details and the procedure classification of the second medical procedure relative to the at least one hygiene standard, wherein the alert indicates noncompliance with the at least one hygiene standard; ([Para. 0109] The system monitor 500 can be used to query the current status of the scope 10. It may also provide a summary of the recent or current activity at the cleaning unit via the cleaning module 240 and the history of the clean storage cabinet via the storage controller 400. [Para. 0078] The storage controller 400 is adapted to alert a user when the clean storage cabinet is not within a predefined parameter.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of reusable medical device reprocessing compliance management as taught by Karumba and incorporate device management system as taught by Smart, with the motivation of To reduce the incidences of infection (Smart Para. 0003).
Karumba/ Smart do not explicitly teach, however Nesterenko teaches
updating, based on the alert, a device status corresponding to the tag in a centralized database, wherein the updating includes providing an indication that the reusable medical device is withdrawn from service. ([Para. 0043] A display 54, such as an LED display, is located in plain view on the door in this embodiment and may be used to visually communicate various information relevant to the pump 22, such as alert indications (e.g., alarm messages). [Para. 0053] On identifying a potential contamination of the one or more medical devices, processor 202 transmits instructions to disable (e.g., electronically lock) each of the one or more identified medical devices (block 606). The processor 202 may update a current status and/or a current state of the identified medical devices as disabled (e.g., “locked”) in response to transmitting the instructions to the identified medical devices. The status or state may cause the device management server 108 to prevent clinicians from logging into the medical device.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of reusable medical device reprocessing compliance management as taught by Karumba, device management system as taught by Smart, and incorporate updating the equipment device status as taught by Nesterenko, with the motivation reducing the risk of exposing medical devices, patients, and/or personnel of a healthcare facility to a contaminate (Nesterenko Para. 0005.)
As per Claims 2 , Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba teaches further comprising determining at least one other medical procedure performed using the reusable medical device and generating an alert identifying at least one other medical procedure as having a risk of cross- contamination. ([Para. 0043] When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc. Before an instrument is used in a procedure, risk assessment controller 214 queries the instrument history (e.g., from past transaction data in the blockchain) and assesses the likelihood of use in the current procedure and may also give recommendations (e.g., use the tool, do not use the tool, use the tool but with certain precautions, etc.). [Para. 0046] Tracking and detecting the use of surgical instrument is accomplished via the computing platform 200 in FIG. 2 by analyzing the instrument history (e.g., sanitization or sterilization state, malfunctions and failures) and cohort by obtaining a historical block identifier of the instrument's historical blockchain, assessing the validity of the instrument is for indicated purposes (e.g., identifying or detecting inappropriate laser for tattoo removal), and matching the instrument and its intended usage (e.g., wrong application, improper use, or unapproved use of equipment). [Para. 0055] The risk assessment can be used to trigger an update to the blockchain and/or be used to provide an alert or initiate some action commensurate with the risk. Thus, advantageously, determining risk R to a patient is based on: i) the results of tracking and detection of surgical instruments; ii) detecting the patient context C (e.g., tattoo removal for a patient with a known latex allergy) and surgical operation to be performed using information from an electronic medical record of the patient (the electronic record may be stored and maintained in another patient record historic blockchain); and iii) analysis of the healthcare personnel cohort (e.g., training or experience with the instrument, experience level with the type of the operation, etc.).)
As per Claim 3, Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba further teaches wherein one or more mobile devices are used for uploading the first reprocessing data and the procedure details of the second medical procedure to a central application, and the central application or the one or more mobile devices automatically generate the alert. ([Para. 0059] the unique identifier (UDI) or fingerprint token for a surgical instrument or tool may be used to form a decentralized instrument Internet of Things (IoT) network, wherein items are “smart devices” that are connected to the blockchain through their corresponding UDI or token. [Para. 0033] detect or determine risk to a patient based on the tracking and detection and advanced analytics, and based on the risk, the computing node (and/or one or more other nodes in the system) sends alerts or notifies health care personnel (e.g., physicians and other healthcare professionals) so they can take appropriate actions. [Para. 0035] the distributed computing platform 200 in FIG. 2 is similar to system 100 in FIG. 1 in that one or more data sources 202 are operatively coupled to a plurality of computing nodes. [Para. 0058] Each computing node in the computing platform 200 is configured to compute blockchain 500. As shown, each block (after block 1) includes a new transaction for the surgical item plus a hash value computed for the previous block. Thus, each data block in the blockchain represents a given set of transaction data plus a set of all previous transaction data, e.g., block N contains data for surgical instrument transaction N plus a hash value that represents all previous N−1 blocks.)
As per Claim 4, Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba teaches further comprising analyzing past medical procedure and reprocessing data of a plurality of reusable medical devices to determine a reprocessing compliance baseline, the reprocessing compliance baseline comprising historical compliance levels of one or more standards, and generating alerts based on determining that future medical procedure and reprocessing data of the plurality of reusable medical devices deviate from the historical compliance levels. ([Para. 0046] a robust instrument tracking solution can help prevent hospital acquired infections by ensuring that each surgical instrument in use is sterilized using the requisite procedures and guidelines. Tracking and detecting the use of surgical instrument is accomplished via the computing platform 200 in FIG. 2 by analyzing the instrument history (e.g., sanitization or sterilization state, malfunctions and failures) and cohort by obtaining a historical block identifier of the instrument's historical blockchain, assessing the validity of the instrument is for indicated purposes (e.g., identifying or detecting inappropriate laser for tattoo removal), and matching the instrument and its intended usage (e.g., wrong application, improper use, or unapproved use of equipment). [Para. 0056] The risk assessment can be used to trigger an update to the blockchain and/or be used to provide an alert or initiate some action commensurate with the risk. Thus, advantageously, determining risk R to a patient is based on: i) the results of tracking and detection of surgical instruments; ii) detecting the patient context C (e.g., tattoo removal for a patient with a known latex allergy) and surgical operation to be performed using information from an electronic medical record of the patient (the electronic record may be stored and maintained in another patient record historic blockchain); and iii) analysis of the healthcare personnel cohort (e.g., training or experience with the instrument, experience level with the type of the operation, etc.). [Para. 0039] Surgical instrument transactions may include, but not be limited to: registering an instrument, updating the status of the instrument, storing the usage information of the instrument, repairing information, test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.). [Para. 0044] Sterilization procedure data set 306: Some diseases (e.g., prion diseases which are a family of progressive neurodegenerative disorders that affect both humans and animals) constitute unique infection control problems. To prevent cross-transmission of infection from reusable medical instruments, after a procedure is carried out, the risk assessment controller 214 recommends the best sterilization procedure.)
As per Claim 7, Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba further teaches wherein the reprocessing further comprises automatically uploading the first reprocessing data. ([Para. 0008] tracking items such as surgical instruments and tools (surgical items) in a health care environment by creating a secure (e.g., validated and protected) chain of data blocks representing transactions associated with the surgical items (e.g., registration, use, sterilization, disposal, risk assessment, etc.). [Para. 0039] Surgical instrument transactions may include, updating the status of the instrument, storing the usage information of the instrument, repairing information, test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.), etc. [Para. 0044] To prevent cross-transmission of infection from reusable medical instruments, after a procedure is carried out, the risk assessment controller 214 recommends the best sterilization procedure. [Para. 0046] a robust instrument tracking solution can help prevent hospital acquired infections by ensuring that each surgical instrument in use is sterilized using the requisite procedures and guidelines. Tracking and detecting the use of surgical instrument is accomplished via the computing platform 200 in FIG. 2 by analyzing the instrument history (e.g., sanitization or sterilization state, malfunctions and failures) and cohort by obtaining a historical block identifier of the instrument's historical blockchain, assessing the validity of the instrument is for indicated purposes (e.g., identifying or detecting inappropriate laser for tattoo removal), and matching the instrument and its intended usage (e.g., wrong application, improper use, or unapproved use of equipment).)
As per Claim 8, Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba further teaches wherein performing the first medical procedure further comprises uploading the first medical procedure data. ([Para. 0038] tools or equipment used in surgical operations may be represented by various properties or parameters, by way of example: a unique identifier (e.g. RFID, barcode, sensor, etc.), type, description (e.g., detailing how to use and handle during a procedure, how to serialize before or after use, etc.), list of authorized users of the instrument, etc. [Para. 0039] Surgical instrument transactions may include, but not be limited to: registering an instrument, updating the status of the instrument, storing the usage information of the instrument, repairing information, test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.), etc. Examiner interprets the updating the status of the instrument, storing the usage information of the instrument to be indicative of loading first and second procedure data. [Para. 0042] Apart from recording the instrument UDI, if the instrument has been in use prior to the date of registration, its history of use is captured and added into the blockchain. [Para. 0043] When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc. Before an instrument is used in a procedure, risk assessment controller 214 queries the instrument history (e.g., from past transaction data in the blockchain) and assesses the likelihood of use in the current procedure and may also give recommendations (e.g., use the tool, do not use the tool, use the tool but with certain precautions, etc.).)
As per Claim 9, Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba further teaches the method further comprises: at the scanning device, automatically analyzing first medical procedure data, wherein the first medical procedure data comprises first patient data; determining a risk to a second patient of a second patient data from a first patient of the first patient data due to a cross-contamination. ([Para. 0042] RFID scanners (i.e. scanning device) may be used to capture such identification data. These identification capture devices are considered part of the transaction data controller 210. [Para. 0032] To provide identification for tracking surgical tools, radio frequency identification (RFID) tags may be employed.[Para. 0001] use of medical instruments with a first patient, followed by reuse with a second patient, has the potential to result in disease transmission from the first patient to the second patient (e.g., assuming the first patient has a transmissible disease) if such instruments are not properly sterilized between procedures. [Para. 0043] When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc. Before an instrument is used in a procedure, risk assessment controller 214 queries the instrument history (e.g., from past transaction data in the blockchain) and assesses the likelihood of use in the current procedure and may also give recommendations (e.g., use the tool, do not use the tool, use the tool but with certain precautions, etc.). Examiner interprets the instrument history to be indicative of more than one history of procedure data. [Para. 0046] Tracking and detecting the use of surgical instrument is accomplished via the computing platform 200 in FIG. 2 by analyzing the instrument history (e.g., sanitization or sterilization state, malfunctions and failures) and cohort by obtaining a historical block identifier of the instrument's historical blockchain, assessing the validity of the instrument is for indicated purposes (e.g., identifying or detecting inappropriate laser for tattoo removal), and matching the instrument and its intended usage (e.g., wrong application, improper use, or unapproved use of equipment). [Para. 0055] The risk assessment can be used to trigger an update to the blockchain and/or be used to provide an alert or initiate some action commensurate with the risk. Thus, advantageously, determining risk R to a patient is based on: i) the results of tracking and detection of surgical instruments; ii) detecting the patient context C (e.g., tattoo removal for a patient with a known latex allergy) and surgical operation to be performed using information from an electronic medical record of the patient (the electronic record may be stored and maintained in another patient record historic blockchain); and iii) analysis of the healthcare personnel cohort (e.g., training or experience with the instrument, experience level with the type of the operation, etc.).)
As per Claim 10, Karumba/ Smart/ Nesterenko teach the method of claim 4, Karumba further teaches wherein the plurality of reusable medical devices comprises mobile reusable medical devices. ([Para. 0037] management of any particular physical item used for providing a medical service, some examples of items that may be tracked through their lifecycle may include: graspers (e.g., such as forceps); clamps and occluders for blood vessels and other organs; retractors (e.g., used to spread open skin, ribs and other tissue); distractors, positioners and stereotactic devices; mechanical cutters (e.g., scalpels, lancets, drill bits, rasps, trocars, ligasure, harmonic scalpel, surgical scissors, rongeurs, etc.); dilators and specula (e.g., for access to narrow passages or incisions); suction tips and tubes (e.g., for removal of bodily fluids); sealing devices (e.g., such as surgical staplers); irrigation and injection needles, tips and tubes (e.g., for introducing fluid); powered devices (e.g., such as drills, dermatomes); scopes and probes (e.g., including fiber optic endoscopes and tactile probes); carriers and appliers for optical, electronic and mechanical devices; ultrasound tissue disruptors, cryotomes and cutting laser guides; and measurement devices (e.g., such as rulers and calipers).)
As per Claim 17, Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba teaches further comprising: reprocessing, based on the alert, the reusable medical device using a second reprocessing procedure; determining the second reprocessing procedure is in compliance with the at least one hygiene standard; and placing, the reusable medical device, into service in response to determining the second reprocessing procedure is in compliance with the at least one hygiene standard. ([Para. 0001] use of medical instruments with a first patient, followed by reuse with a second patient, has the potential to result in disease transmission from the first patient to the second patient (e.g., assuming the first patient has a transmissible disease) if such instruments are not properly sterilized between procedures. [Para. 0033] each computing node in the system is configured to track and detect the use of surgical items, detect or determine risk to a patient based on the tracking and detection and advanced analytics, and based on the risk, the computing node (and/or one or more other nodes in the system) sends alerts or notifies health care personnel (e.g., physicians and other healthcare professionals) so they can take appropriate actions. [Para. 0043] Before an instrument is used in a procedure, risk assessment controller 214 queries the instrument history (e.g., from past transaction data in the blockchain) and assesses the likelihood of use in the current procedure and may also give recommendations (e.g., use the tool, do not use the tool, use the tool but with certain precautions, etc.). [Para. 0044] To prevent cross-transmission of infection from reusable medical instruments, after a procedure is carried out, the risk assessment controller 214 recommends the best sterilization procedure. [Para. 0056] The risk assessment can be used to trigger an update to the blockchain and/or be used to provide an alert or initiate some action commensurate with the risk. Thus, advantageously, determining risk R to a patient is based on: i) the results of tracking and detection of surgical instruments; ii) detecting the patient context C (e.g., tattoo removal for a patient with a known latex allergy) and surgical operation to be performed using information from an electronic medical record of the patient (the electronic record may be stored and maintained in another patient record historic blockchain))
As per Claim 18, Karumba/ Smart/ Nesterenko teach the method of claim 1, Karumba further teaches wherein the second reprocessing procedure is determined based on the procedure details of the second medical procedure. ([Para. 0038] instruments, tools or equipment used in surgical operations may be represented by various properties or parameters, by way of example: a unique identifier (e.g. RFID, barcode, sensor, etc.), type, description (e.g., detailing how to use and handle during a procedure, how to serialize before or after use, etc.), list of authorized users of the instrument, etc. [Para. 0039] Surgical instrument transactions may include, but not be limited to: registering an instrument, updating the status of the instrument, storing the usage information of the instrument, repairing information, test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.), etc. . [Para. 0043] Instrument use data set 304: When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc. Examiner interprets the any new transaction entry added to the blockchain is indicative of uploading data.)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart (US 20170091398 A1) in view of Nesterenko (US 20210059784 A1) in view of Polley (US 20190331701 A1).
As per Claim 5, Karumba/ Smart/ Jinadatha teach the method of claim 1, however Polley teaches further comprising analyzing governing laws, standards, guidelines and instructions for use of reusable medical devices to determine a reprocessing compliance baseline. ([Para. 0028] whether the cleaning practices adhere to cleaning protocol, procedures, and meet various requirements, e.g., CDC requirements, hospital standard operating procedures, and/or other requirements.[Para. 0029] For example, observation of how a cleaner conducts their duties while cleaning or observation checklists to assess how well a healthcare worker addresses hand hygiene while attending to patients or performing other hygiene critical tasks. Examiner interprets the checklist to be indicative of reprocessing compliance baseline.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of reusable medical device reprocessing compliance management as taught by Karumba, device management system by Smart, updating the equipment device status as taught by Nesterenko, and incorporate analyzing governing laws, standards, guidelines and instructions for use of reusable medical devices to determine a reprocessing compliance baseline as taught by Polley, with the motivation creating a centralized system to reduce inconsistencies in the reporting or alert of contamination due to, for example, processing delays with respect to each practice, overall inaccuracies and inefficiencies, or monitoring activities can be missed by ineffective scheduling, and data may be dispersed and disorganized, which may make it difficult to track and analyze the monitoring of the environment (Polley Para. 0002).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart (US 20170091398 A1) in view of Nesterenko (US 20210059784 A1) in view of Jinadatha (US 20150205985 A1) in view of Presterl (Medical Instruments and Devices (2019)).
As per Claim 6, Karumba/ Smart/ Nesterenko teach the method of claim 1, Jinadatha further teaches wherein the reprocessing further comprises a reprocessing device automatically uploading the first reprocessing data ([Para. 0107] Each RFID tagged equipment is managed by a Wi-Fi or similar technology enabled central data warehouse through a fixed reader in each of the equipment holding rooms. Once the UV device equipped with the Jangama is used to clean the RME it records each uniquely tagged RME and transmits that information to the central database/Management system. This database may be updated on a real time basis, meaning, e.g., that it updates with each cleaning and each movement of the RFID tagged RME. An UV operator may be able to access this information on the UV device using the mobile reader/transmitter/storage/display unit (Jangama) on a real time basis as well, thereby alerting the operator to the holding areas in need of clean equipment.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of reusable medical device reprocessing compliance management as taught by Karumba, device management system as taught by Smart, updating the equipment device status as taught by Nesterenko, and incorporate the reprocessing further comprises a reprocessing device automatically uploading the reprocessing data as taught by Jinadatha, with the motivation alleviating inadequate cleaning practices and should radically and systematically reduce the contamination on equipment or supplies and in-patient rooms (Jinadatha Para. 0004-0005).
Jinadatha does not explicitly teach, however Presterl teaches
wherein the at least one hygiene standard is extracted from governing laws, standards, guidelines, or instructions associated with the procedure classification, and wherein the procedure classification provides an indication of a type of skin contact associated with the second medical procedure. ([Pg. 2-3 4.2 Risk Classification for Medical Devices] The classification into risk classes is based on the necessary reprocessing procedure. The operator is responsible for the correct classification of the MD and the determination of the treatment methods, taking into account the information provided by the product manufacturer. The level of terminal reprocessing required by medical devices is based on the classification system developed by Spaulding in 1970. It classifies medical devices (MDs) into three categories (i.e. procedure classification (see Specification Para. 0036)), based on the client/patient/resident’s risk of infection due to contact with various types of devices. The correct reprocessing procedure should minimize the risk of residues from previous applications (e.g. blood, secretions, blood or body components) or changes in material properties (e.g. embrittlement, accelerated wear of materials, changes in surface properties). Spaulding classification (i.e. governing standards) according to risk levels categorized medical devices into (1) noncritical MDs which come in contact with intact skin (i.e. type of skin contact); (2) semi-critical MDs which come in contact with mucous membrane, wounds or non-intact skin (i.e. type of skin contact); or (3) critical MDs which come in contact with blood, blood products, primarily sterile tissue or in MDs which penetrate the skin or mucous membranes and come into contact with the human blood system, tissue or organs (i.e. type of skin contact).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of secure chain of data blocks that track medical instrument usage during medical procedure as taught by Karumba, device management system as taught by Smart, updating the equipment device status as taught by Nesterenko, organizing the disinfection of one or more items contaminated with biological agent(s) as taught by Jinadatha, and incorporate risk assessment of the reprocessed medical devices as taught by Presterl, with the motivation of avoid pathogen transmission (Presterl Pg. 1 Abstract).
Claim(s) 11, 13, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart (US 20170091398 A1).
As per Claim 11, Karumba teaches a system for hygiene standards compliance of an environment or a device, the system comprising:
a central application; ([Para. 0046] tracking and detecting the use of surgical instrument is accomplished via the computing platform 200 in FIG. 2. Examiner interprets the computing platform to be indicative of a central application.)
one or more mobile devices, the one or more mobile devices configured to: ([Para. 0059] the unique identifier (UDI) or fingerprint token for a surgical instrument or tool may be used to form a decentralized instrument Internet of Things (IoT) network, wherein items are “smart devices” that are connected to the blockchain through their corresponding UDI or token. Examiner interprets these smart devices of being indicative of one or more mobile devices.)
upload, over a network, reprocessing data to the central application, the reprocessing data relating to a reprocessing procedure of the environment or the device after a first procedure is performed; ([Para. 0024] Blockchain is the name given to a technology that enables creation of a digital ledger or record of transactions and sharing of this ledger or record among a distributed network of computers. [Para. 0038] instruments, tools or equipment used in surgical operations may be represented by various properties or parameters, by way of example: a unique identifier (e.g. RFID, barcode, sensor, etc.), type, description (e.g., detailing how to use and handle during a procedure, how to serialize before or after use, etc.), list of authorized users of the instrument, etc. [Para. 0039] Surgical instrument transactions may include, but not be limited to: registering an instrument, updating the status of the instrument, storing the usage information of the instrument, repairing information, test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.), etc. [Para. 0040] All of the above data representing ID, location, use (as well as other data) with respect to a given surgical item is considered transaction data. Such transaction data is what is provided to any given computing node 204-1, 204-2, 204-3, 204-4, . . . , 204-N (from data source 202 or some other computing node) for use in computing a blockchain, for example, as described above in the context of FIG. 1. The transaction data controller 210 is configured to receive or otherwise obtain the transaction data for each computing node, while the blockchain controller 212 is configured to compute the blockchain for each computing node. [Para. 0041] FIG. 3A illustrates a temporal life span 300 (T.sub.0 through T.sub.M) of a surgical item (surgical instrument, in this example) with the various transaction data sets 302 through 308 that may be tracked during that time period. [Para. 0042] Instrument registration data set 302: Each instrument may be assigned a unique device identifier (UDI) and the registration of a surgical instrument is added to the blockchain ledger. Apart from recording the instrument UDI, if the instrument has been in use prior to the date of registration, its history of use is captured and added into the blockchain. [Para. 0043] Instrument use data set 304: When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc. Before an instrument is used in a procedure, risk assessment controller 214 queries the instrument history (e.g., from past transaction data in the blockchain) and assesses the likelihood of use in the current procedure and may also give recommendations (e.g., use the tool, do not use the tool, use the tool but with certain precautions, etc.).)
Karumba does not explicitly teaches, however Smart teaches
query, via a graphical user interface, for procedure details and a procedure classification of a second procedure before the second procedure is performed; ([Para. 0052] The master station 100 programs the tag 20 and operator tag 30. In particular, the master station 100 programs the tag 20 with information including i) a Unique Identification Number (UID); ii) the type of scope 10; iii) the name of the scope 10; iv) the amount of time the scope 10 is allowed outside of a clean storage environment once it has been cleaned; and v) the length of time the scope 10 can be stored in the clean storage environment. [Para. 0056] The process modules 220 monitor operator workflow associated with the scope 10 before proceeding to an automatic cleaning unit associated with the cleaning module 240. [Para. 0064-0065] The third process module 220c allows the operator to register that the scope 10 has been manually washed and rinsed (according to guidelines). Examiner interprets the use of automatic/ automated vs. manual washing procedures to be indicative of procedure classification. The process module 220c is configured to record on the tag 20 that the scope 10 has been manually washed and rinsed after the operator swipes their operator tag 30 proximate to the third process module 220c followed by the tag 20. [Para. 0073] The cleaning module 240 records the cleaning of the scope 10 in an associated cleaning unit. For example, the cleaning module 240 records whether a short, standard or long wash has been used to clean the scope 10 in the associated cleaning unit. Furthermore, other parameters such as whether alcohol was used in the clean cycle are recorded. In this regard, the cleaning module 240 is configured to receive a validity indication from the associated cleaning unit that the scope 10 has been cleaned according to a particular wash cycle. [Para. 0109] The system monitor 500 can be used to query the current status of the scope 10. It may also provide a summary of the recent or current activity at the cleaning unit via the cleaning module 240 and the history of the clean storage cabinet via the storage controller 400.)
transmit, via the graphical user interface, instructions based on the procedure details and the procedure classification of the second procedure; ([Para. 0077] The status device 300 is also configured to assist in determining cross-contamination. That is, if the status device 300 detects, via the tag 20, that the scope 10 has not been processed correctly through the process modules 220 or a validity indication has not been received from the cleaning unit and/or the cleaning module 240 (i.e. analysis of procedure classification relative to at least one hygiene standard), the status device 300 is configured to indicate that other scopes adjacent thereto have been contaminated. For example, the LED displays may indicate that the scope 10 and the scopes adjacent thereto must be re-cleaned.)
upload, over the network, second procedure data of a second procedure involving the environment or the device to the central application, wherein the central application automatically transmits an alert based on comparing the procedure details, the procedure classification, and the second procedure data of the second procedure and the reprocessing data with a plurality of hygiene standards, the alert indicating noncompliance with at least one of the plurality of hygiene standards. ([Para. 0109] The system monitor 500 can be used to query the current status of the scope 10. It may also provide a summary of the recent or current activity at the cleaning unit via the cleaning module 240 and the history of the clean storage cabinet via the storage controller 400. [Para. 0078] The storage controller 400 is adapted to alert a user when the clean storage cabinet is not within a predefined parameter.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of reusable medical device reprocessing compliance management as taught by Karumba and incorporate device management system as taught by Smart, with the motivation of to reduce the incidences of infection (Smart Para. 0003).
As per Claim 13, Karumba/ Smart teach the system of claim 11, Karumba further teaches wherein the central application further determines at least one other procedure performed using the environment or the device and generates an alert identifying the at least one other procedure as having a risk of cross-contamination. ([Para. 0043] When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc. Before an instrument is used in a procedure, risk assessment controller 214 queries the instrument history (e.g., from past transaction data in the blockchain) and assesses the likelihood of use in the current procedure and may also give recommendations (e.g., use the tool, do not use the tool, use the tool but with certain precautions, etc.). [Para. 0046] Tracking and detecting the use of surgical instrument is accomplished via the computing platform 200 in FIG. 2 by analyzing the instrument history (e.g., sanitization or sterilization state, malfunctions and failures) and cohort by obtaining a historical block identifier of the instrument's historical blockchain, assessing the validity of the instrument is for indicated purposes (e.g., identifying or detecting inappropriate laser for tattoo removal), and matching the instrument and its intended usage (e.g., wrong application, improper use, or unapproved use of equipment). [Para. 0055] The risk assessment can be used to trigger an update to the blockchain and/or be used to provide an alert or initiate some action commensurate with the risk. Thus, advantageously, determining risk R to a patient is based on: i) the results of tracking and detection of surgical instruments; ii) detecting the patient context C (e.g., tattoo removal for a patient with a known latex allergy) and surgical operation to be performed using information from an electronic medical record of the patient (the electronic record may be stored and maintained in another patient record historic blockchain); and iii) analysis of the healthcare personnel cohort (e.g., training or experience with the instrument, experience level with the type of the operation, etc.).)
As per Claim 16, Karumba/ Smart teach the system of Claim 11, Karumba further teaches wherein the central application correlates historical procedure data to determine persons exposed to a hygiene risk by the noncompliance with the at least one of the plurality of hygiene standards. ([Para. 0001] the use of medical instruments with a first patient, followed by reuse with a second patient, has the potential to result in disease transmission from the first patient to the second patient (e.g., assuming the first patient has a transmissible disease) if such instruments are not properly sterilized between procedures. [Para. 0033] each computing node in the system is configured to track and detect the use of surgical items, detect or determine risk to a patient based on the tracking and detection and advanced analytics, and based on the risk, the computing node (and/or one or more other nodes in the system) sends alerts or notifies health care personnel (e.g., physicians and other healthcare professionals) so they can take appropriate actions. [Para. 0056] determining risk R to a patient is based on: i) the results of tracking and detection of surgical instruments; ii) detecting the patient context C (e.g., tattoo removal for a patient with a known latex allergy) and surgical operation to be performed using information from an electronic medical record of the patient (the electronic record may be stored and maintained in another patient record historic blockchain); and iii) analysis of the healthcare personnel cohort (e.g., training or experience with the instrument, experience level with the type of the operation, etc.).)
As per Claim 19, Karumba/ Smart teach the system of claim 11, Karumba further teaches wherein the graphical user interface is configured to obtain the procedure details of the second procedure from a user before the second procedure is performed by the user. ([Para. 0038] instruments, tools or equipment used in surgical operations may be represented by various properties or parameters, by way of example: a unique identifier (e.g. RFID, barcode, sensor, etc.), type, description (e.g., detailing how to use and handle during a procedure, how to serialize before or after use, etc.), list of authorized users of the instrument, etc. [Para. 0039] Surgical instrument transactions may include, but not be limited to: registering an instrument, updating the status of the instrument, storing the usage information of the instrument, repairing information, test results of surgical instruments (e.g., material safety assessment, sterilization efficacy for reusable device, biocompatibility, heat test, etc.), etc. . [Para. 0043] Instrument use data set 304: When an instrument is used in any operation location L, a transaction entry of use is added to the blockchain detailing the kind of procedure done, the user or doctor, patient disease(s), etc.)
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart (US 20170091398 A1) in view of Jurak (US 20170072082 A1).
As per Claim 12, Karumba/ Smart teach the system of claim 11, however Jurak teaches wherein the environment comprises an emergency vehicle. ([Para.0059] a plurality of environments 12, for example an ambulance fleet including a plurality of ambulances. The system can also include other types of environments 12 such as one or more mobile hospitals, mobile clinics, mobile laboratories, life flight helicopters, urgent and non-urgent vehicles for medical transport, and hospital rooms.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of hygiene standards compliance of an environment as taught by Karumba, device management system as taught by Smart, and incorporate the environment comprises an emergency vehicle as taught by Jurak, with the motivation of or identifying enclosed spaces, sterilizing the identified enclosed spaces through ozone generation (Jurak Para. 0003).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart (US 20170091398 A1) in view of Polley (US 20190331701 A1).
As per Claim 14, Karumba/ Smart teaches system of claim 11, however Polley teaches wherein the central application further analyzes governing laws, standards, guidelines and instructions for use of the environment or the device to determine a reprocessing compliance baseline. ([Para. 0028] whether the cleaning practices adhere to cleaning protocol, procedures, and meet various requirements, e.g., CDC requirements, hospital standard operating procedures, and/or other requirements.[Para. 0029] For example, observation of how a cleaner conducts their duties while cleaning or observation checklists to assess how well a healthcare worker addresses hand hygiene while attending to patients or performing other hygiene critical tasks. Examiner interprets the checklist to be indicative of reprocessing compliance baseline.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of reusable medical device reprocessing compliance management as taught by Karumba, device management system as taught by Smart, and incorporate analyzing governing laws, standards, guidelines and instructions for use of reusable medical devices to determine a reprocessing compliance baseline as taught by Polley, with the motivation creating a centralized system to reduce inconsistencies in the reporting or alert of contamination due to, for example, processing delays with respect to each practice, overall inaccuracies and inefficiencies, or monitoring activities can be missed by ineffective scheduling, and data may be dispersed and disorganized, which may make it difficult to track and analyze the monitoring of the environment (Polley Para. 0002).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart (US 20170091398 A1) in view of Presterl (Medical Instruments and Devices (2019)).
As per Claim 15, Karumba / Smart teach the system of claim 11, Karumba further teaches wherein the central application automatically receives the second procedure data ([Para. 0063] a computing node in the computing platform 200 receives transaction data associated with the surgical instrument. [Para. 0046] racking and detecting the use of surgical instrument is accomplished via the computing platform 200 in FIG. 2 by analyzing the instrument history (e.g., sanitization or sterilization state, malfunctions and failures) and cohort by obtaining a historical block identifier of the instrument's historical blockchain, assessing the validity of the instrument is for indicated purposes (e.g., identifying or detecting inappropriate laser for tattoo removal), and matching the instrument and its intended usage (e.g., wrong application, improper use, or unapproved use of equipment). [Para. 0058] Each computing node in the computing platform 200 is configured to compute blockchain 500. As shown, each block (after block 1) includes a new transaction for the surgical item plus a hash value computed for the previous block. Thus, each data block in the blockchain represents a given set of transaction data plus a set of all previous transaction data, e.g., block N contains data for surgical instrument transaction N plus a hash value that represents all previous N−1 blocks.)
Karumba does not explicitly teach, however Presterl teaches
wherein the at least one hygiene standard is extracted from governing laws, standards, guidelines, or instructions associated with the procedure classification, and wherein the procedure classification provides an indication of a type of skin contact associated with the second procedure. ([Pg. 2-3 4.2 Risk Classification for Medical Devices] The classification into risk classes is based on the necessary reprocessing procedure. The operator is responsible for the correct classification of the MD and the determination of the treatment methods, taking into account the information provided by the product manufacturer. The level of terminal reprocessing required by medical devices is based on the classification system developed by Spaulding in 1970. It classifies medical devices (MDs) into three categories (i.e. procedure classification (see Specification Para. 0036)), based on the client/patient/resident’s risk of infection due to contact with various types of devices. The correct reprocessing procedure should minimize the risk of residues from previous applications (e.g. blood, secretions, blood or body components) or changes in material properties (e.g. embrittlement, accelerated wear of materials, changes in surface properties). Spaulding classification (i.e. governing standards) according to risk levels categorized medical devices into (1) noncritical MDs which come in contact with intact skin (i.e. type of skin contact); (2) semi-critical MDs which come in contact with mucous membrane, wounds or non-intact skin (i.e. type of skin contact); or (3) critical MDs which come in contact with blood, blood products, primarily sterile tissue or in MDs which penetrate the skin or mucous membranes and come into contact with the human blood system, tissue or organs (i.e. type of skin contact).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of secure chain of data blocks that track medical instrument usage during medical procedure as taught by Karumba, device management system as taught by Smart, and incorporate risk assessment of the reprocessed medical devices as taught by Presterl, with the motivation of avoid pathogen transmission (Presterl Pg. 1 Abstract).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karumba (US 20180189449 A1) in view of Smart ( US 20170091398 A1) in view of Jinadatha (US 20150205985 A1).
As per Claim 20, Karumba/ Smart teach the system of claim 11, however Jinadatha teach wherein the reprocessing data includes a disinfection status or sterilization status of the environment or the device after a first reprocessing procedure of the environment or the device is performed. ([Para. 0036] Mobile readers (which may be housed in a mobile unit, e.g., Jangama) may be used with the no-touch disinfection devices to alert environmental services staff of equipment in need of cleaning (also referred to herein as disinfecting) within an interrogation zone. [Para. 0105] The central data warehouse may be equipped with appropriate software to recognize all tagged equipment, their location and searchable properties like some of the current RFID vendors. The database may also be able to locate each UV or equivalent device and be able to update device maintenance logs. [Para. 0107] Once the UV device equipped with the Jangama is used to clean the RME it records each uniquely tagged RME and transmits that information to the central database/Management system. This database may be updated on a real time basis, meaning, e.g., that it updates with each cleaning and each movement of the RFID tagged RME.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of reusable medical device reprocessing compliance management as taught by Karumba, device management system as taught by Smart, and incorporate updating the equipment device status as taught by Jinadatha, with the motivation alleviating inadequate cleaning practices and should radically and systematically reduce the contamination on equipment or supplies and in-patient rooms (Jinadatha Para. 0004-0005).
Response to Arguments
Applicant's arguments, see pgs.7-13 “Claim Rejections – 35 U.S.C. 101” filed 09/08/2025 have been fully considered but they are not persuasive.
Applicant argues that the claimed invention does not recite a judicial exception and is not directed towards a method of organizing human activity. Examiner respectfully disagrees. The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to obtain and extract medical data. The Examiner notes that Applicant’s background (Para. 0003) in suggests an instant response describes the invention as providing a solution to the “growing need to manage the traceability of reprocessing and patronage of other medical environments including medical treatment rooms, patient environments and bathrooms, medical transport etc. as well as other facilities and environments that may be used to house or treat patients that pose cross contamination risk. Reprocessing of these reusable medical devices and environments is required to be managed in accordance with laws, standards, guidelines or internal standard operating procedures to reduce risk of cross contamination. Frequently, information related to the reprocessing of reusable medical devices and environments is held in separate, complicated and difficult to manage paper based systems that are frequently mismanaged or lost leading these systems to be ineffective in providing effective traceability and compliance to laws, standards, guidelines or internal standard operating procedures to adequately protect patients by providing needed traceability evidence to manage cross contamination risk and outbreak efficiently.”- these behaviors are best categorized as human task. Claim 1 comprises the steps of reprocessing the reusable medical [tool] using a first reprocessing procedure; identifying the reusable medical [tool] for use in a second medical procedure; obtaining first reprocessing data of the reusable medical device; scanning, a tag attached to the reusable medical [tool], wherein the tag identifies the reusable medical device; querying for procedure details of the second medical procedure; automatically analyzing the first reprocessing data and the procedure details of the second medical procedure relative to at least one hygiene standard; updating a [tool] status corresponding to the tag, wherein the updating includes providing an indication that the reusable medical device is withdrawn from service, uploading second procedure data of a second procedure involving the environment or the [tool] are best categorized as a human task. Applicant has not pointed to anything in the claims or the specification that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions that a person or person would follow to obtain and extract medical data, the claimed invention is directed to an abstract idea.
The reusable medical device, a graphical user interface of a scanning device, a scanning device, a centralized database, a central application, one or more mobile devices, and a network are additional elements recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application. Claims 1 and 11 recite automatically transmitting an alert, which is merely recites as a tool which only serves as extra solution activities incidental to the primary process that is merely a nominal or tangential addition to the claim (MPEP § 2106.05(g)).
Applicant argues that the limitations are directed to transmitting an alert by a scanning device and updating a centralized database based on the alert, which amount to additional elements that integrate the judicial exception into a practical application. Thus, the claimed features clearly improve the technical field of traceability and hygiene compliance management of reprocessing of reusable medical devices and environments. Accordingly, the claims satisfy one or more of the above factors (e.g., improve the computer and/or another technology), and are considered to integrate any alleged judicial exception into a practical application, thereby complying with 35 U.S.C. §101. Examiner respectfully disagrees. The step of transmitting an alert by a scanning device is recited as a tool which only serves as extra solution activities incidental to the primary process that is merely a nominal or tangential addition to the claim (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception. The step of updating a centralized database based on the alert is part of the abstract idea. Improving the traceability and hygiene compliance management of reprocessing of reusable medical devices and environments is an improvement to the abstract ideas and does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to obtaining and organizing medical data. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
Applicant argues that transmitting an alert by a scanning device and updating a centralized database based on the alert, which amount to significantly more than the judicial exception. Examiner respectfully disagrees. The updating of data based on an alert has been identified as part of the abstract idea. The limitation of updating The consideration under Step 2B is if the additional elements, 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 of Claim 1 reciting a reusable medical device, a graphical user interface of a scanning device, a scanning device, a centralized database and Claim 11 reciting a central application, one or more mobile devices, and a network, alone or in combination, amount to instruction to implement the abstract idea using a general-purpose computer. The step of automatically transmitting an alert is recited as a tool which only serves as extra solution activities incidental to the primary process that is merely a nominal or tangential addition to the claim (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception.
Applicant's arguments, see pgs. 13-14 “Claim Rejections- 35 U.S.C. 102” filed 09/08/2025 have been fully considered are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Smart, as per the rejection above.
Applicant's arguments, see pgs. 14-15 “Claim Rejections- 35 U.S.C. 103” filed 09/08/2025 have been fully considered are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of newly cited references Smart, Nesterenko, and Presterl, as per the rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/P.K.E./ Examiner, Art Unit 3681
/PETER H CHOI/ Supervisory Patent Examiner, Art Unit 3681