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 .
Election/Restrictions
Applicant’s election of Group III, Claims 11-18, in the reply filed on 04/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 11 is objected to because of the following informalities: the limitations of claim 11 are recited as: “(f) receiving… (f) providing… (g) performing….” The second “(f)” recitation in the numbering of limitations appears to be a repetitive error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 11, the claim recites “providing information associated with the first and second medical device processing components to the user device” in limitation (d) of the claim. It is unclear which user device is being referenced or if only one user device was intended. Both limitations (c) and (d) make reference to “a user device,” but for examination purposes it is understood to be the same user device. Appropriate correction is required. The dependent claims are also rejected due to inheriting the problems of the independent claim.
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 11-18 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 of the Alice/Mayo Test
Claims 11-18 are drawn to a method, which is within the four statutory categories (i.e. process).
Step 2A of the Alice/Mayo Test - Prong One
The independent claim recites an abstract idea. For example, claim 11 recites:
A method for monitoring and managing a network of medical device processing components comprising the steps:
(a) connecting a first medical device processing component to a communication hub;
(b) connecting a second medical device processing component to the communication hub;
(c) in response to a request from a user device, providing a list of devices associated with the communication hub to the user device;
(d) in response to a request from a user device, providing information associated with the first and second medical device processing components to the user device;
(e) performing a first task with the first medical device processing component;
(f) receiving, at the communication hub, a task record from the first medical device processing component, the task record describing the first task;
(f) providing the task record to a second medical device processing component; and
(g) performing a second task with the second medical device processing component.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the first and second medical device processing components, communication hub, user device the limitations in the context of this claim encompass an automation of organizing medical device information and communicating information to manage a workflow of tasks to be performed. If a claim limitation, under its broadest reasonable interpretation, covers management of management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 12-18 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 11 recites:
A method for monitoring and managing a network of medical device processing components comprising the steps:
(a) connecting a first medical device processing component to a communication hub; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(b) connecting a second medical device processing component to the communication hub; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(c) in response to a request from a user device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) providing a list of devices associated with the communication hub to the user device; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(d) in response to a request from a user device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) providing information associated with the first and second medical device processing components to the user device; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(e) performing a first task with the first medical device processing component; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(f) receiving, at the communication hub, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) a task record from the first medical device processing component, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) the task record describing the first task;
(f) providing the task record to a second medical device processing component; and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(g) performing a second task with the second medical device processing component. (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the first and second medical device processing components, communication hub, user device, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0079], [00336], see MPEP 2106.05(f))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 12-18 recite additional limitations which amount to furthering the abstract idea; claims 12-16, 18 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea; and claims 12-18 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the first and second medical device processing components, communication hub, user device, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0079], [00336]); using the first and second medical device processing components, communication hub, user device, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-12, 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sunkara et al. (US 2015/0118107) in view of Kirckof et al. (U.S. Patent No. 6,485,978).
Regarding claim 11, Sunkara discloses a method for monitoring and managing a network of medical device processing components comprising the steps:
(a) connecting a first medical device processing component to a communication hub; (b) connecting a second medical device processing component to the communication hub; (Sunkara [0017] In some embodiments, the apparatus further comprises a system for identifying and tracking items of medical or laboratory apparel and/or accessories, hereinafter referred to as a garment identification or tracking system. In some embodiments, the garment identification or tracking system comprises a sensor that is used in conjunction with identification tags for the one or more items of medical or laboratory apparel and/or accessories (e.g., a sensor or scanner that reads an identification tag attached to an item of medical or laboratory apparel or accessory). In some embodiments, the garment identification or tracking system comprises a radio-frequency identification (RFID) reader mounted on the carriage or at a suitable location in or on the cabinet and an RFID tag for each of the one or more items of medical or laboratory apparel and/or accessories. In some embodiments, the RFID tag is attached to the item of medical or laboratory apparel and/or accessory. In some embodiments, the garment identification or tracking system comprises a barcode reader mounted on the carriage or at a suitable location in or on the cabinet and a barcode tag for each of the one or more items of medical or laboratory apparel and/or accessories. In some embodiments, the garment identification or tracking system comprises one or more identification tags that are used in conjunction with a sensor in a mobile device. For example, the embedded computer or PLC receives data from a tag associated with an article of apparel and communicates an electronic message to a user's mobile device via a sensor in the mobile device… the garment identification or tracking system is capable of capturing disinfection status information on each item of medical or laboratory apparel and/or accessory and processing the data for usage analysis or for providing status updates to users)
(c) in response to a user device, providing a list of devices associated with the communication hub to the user device; (Sunkara [0017] For example, the embedded computer or PLC receives data from a tag associated with an article of apparel and communicates an electronic message to a user's mobile device via a sensor in the mobile device… the garment identification or tracking system is capable of capturing disinfection status information on each item of medical or laboratory apparel and/or accessory and processing the data for usage analysis or for providing status updates to users [0018] In some embodiments, the apparatus further comprises a display screen mounted to the exterior of the cabinet. In some embodiments, the display screen comprises a Human Machine Interface (HMI) through which a user can unlock the apparatus, determine the status of a disinfection cycle or disinfection status of an item of apparel or accessory, and/or determine the location within the apparatus of an item of medical or laboratory apparel and/or accessory associated with the user. [0101] Quickscan protocol: A quickscan protocol enables a user to place an item of apparel and/or accessory in the cabinet for immediate or expedited disinfection. Initiation of this protocol places the item in a top position in the pre-scan list for priority disinfection)
(d) in response to a user device, providing information associated with the first and second medical device processing components to the user device; (Sunkara [0017] For example, the embedded computer or PLC receives data from a tag associated with an article of apparel and communicates an electronic message to a user's mobile device via a sensor in the mobile device. This message may include, for example, a reminder to disinfect the user's lab coat at the end of every 8 hour workday. In particular embodiments, a tracking system (e.g., an RFID reader, barcode reader, etc.) is housed in the cabinet and is configured to communicate with a device (e.g., an RFID tag, barcode tag, etc.) located on an item of apparel or accessory to enable the apparatus to transmit electronic messages to a user (e.g., reminders to disinfect an item at pre-determined intervals). In certain preferred embodiments, the garment identification or tracking system is capable of capturing disinfection status information on each item of medical or laboratory apparel and/or accessory and processing the data for usage analysis or for providing status updates to users. [0101] Quickscan protocol: A quickscan protocol enables a user to place an item of apparel and/or accessory in the cabinet for immediate or expedited disinfection. Initiation of this protocol places the item in a top position in the pre-scan list for priority disinfection)
(e) performing a first task with the first medical device processing component; (Sunkara [0033] (b) exposing the one or more items of medical or laboratory apparel and/or accessories to the at least one disinfecting agent under conditions suitable for inactivating or killing pathogens, thereby disinfecting or sterilizing the one or more items of medical or laboratory apparel and/or accessories)
(f) receiving, at the communication hub, a task record from the first medical device processing component, the task record describing the first task; (Sunkara [0088] The post-scan list is a list of hanger locations for which a scan cycle has been completed (i.e., a disinfection cycle has been completed… one or more items of apparel and/or accessories are placed in the cabinet for disinfection, sensors (e.g., RFID or other forms) on the apparel and/or accessories communicate information to the embedded computer or PLC to allow the apparatus to differentiate the disinfected apparel from the non-disinfected apparel to avoid repetitious disinfection of the apparel and/or accessories)
(f) providing the task record to a second medical device processing component; and (g) performing a second task with the second medical device processing component. (Sunkara [0093] The location of the hanger is removed from the pre-scan list and added to the post-scan list. If other apparel and/or accessories are present in the cabinet, the carriage is relocated to a fixed start position at a set distance away from the position of the next hanger on the pre-scan list and the next scan cycle commences as it did for the first hanger on the pre-scan list. After all the hanger locations in the pre-scan list are disinfected, the calibration process is initiated and the carriage returns to its default position)
Sunkara does not appear to explicitly disclose, however Kirckof teaches it is old and well known in the art of sterilization wherein:
request from the user device (Kirckof column 19, lines 50-63; column 20 lines 36-37; column 21 lines 15-22; column 25, lines 15-55 teaches a computer being programmed to receive information from a personal computer which can be used to customize the sterilization process).
Therefore, it would have been obvious to one of ordinary skill in the art of sterilization, before the effective filing date of the claimed invention, to modify Sunkara to incorporate a request from the user device, as taught by Kirckof, in order to send the information directly to the computer and allow for customization and the particular needs of a hospital or user. See Kirckof column 21 lines 5-22.
Regarding claim 12, Sunkara-Kirckof teaches the method of claim 11, wherein connecting the first medical device processing component to the communication hub comprises:(i) receiving a device connection request from the user device; (Kirckof column 19, lines 50-63; column 20 lines 36-37; column 21 lines 15-22; column 25, lines 15-55) (ii) causing the user device to display a connection interface; (Sunkara [0018] In some embodiments, the apparatus further comprises a display screen mounted to the exterior of the cabinet. In some embodiments, the display screen comprises a Human Machine Interface (HMI) through which a user can unlock the apparatus, determine the status of a disinfection cycle or disinfection status of an item) (iii) receiving a set of device connection information from the user device; and (Sunkara [0101] Quickscan protocol: A quickscan protocol enables a user to place an item of apparel and/or accessory in the cabinet for immediate or expedited disinfection. Initiation of this protocol places the item in a top position in the pre-scan list for priority disinfection) (iv) attempting a connection to the first medical device processing component using the set of device connection information, wherein the connection interface comprises a set of connection instructions. (Kirckof column 22, lines 1-7 and 30-40; column 20, lines 40-60).
Regarding claim 14, Sunkara-Kirckof teaches the method of claim 1, wherein the first medical device processing component comprises a sterilizing cabinet; wherein providing information associated with the first and second medical device processing components to the user device comprises causing a device overview interface to display on the user device, wherein the device overview interface comprises two or more of: (i) a device identifier; (ii) a sterilization cycle summary; (iii) a sterilization cycle table; and (iv) a sterilization cycle visualization. (Sunkara [0018] In some embodiments, the apparatus further comprises a display screen mounted to the exterior of the cabinet. In some embodiments, the display screen comprises a Human Machine Interface (HMI) through which a user can unlock the apparatus, determine the status of a disinfection cycle or disinfection status of an item of apparel or accessory, and/or determine the location within the apparatus of an item of medical or laboratory apparel and/or accessory associated with the user. [0100] the GUI displays an estimate of when disinfection of the item will be complete. This estimate may be based on the product of an average scan cycle time and number of items above the item in the list).
Regarding claim 15, Sunkara-Kirckof teaches the method of claim 14, wherein the sterilization cycle summary comprises a total number of cycles, an average cycles per day, and a number of cycles including a biological indicator; wherein the sterilization cycle table comprises a set of rows, each row corresponding to a single sterilization cycle performed by the first medical device processing component; (Sunkara [0100] the GUI displays an estimate of when disinfection of the item will be complete. This estimate may be based on the product of an average scan cycle time and number of items above the item in the list) [0122] Observations: Anywhere from 2-100 CFU (colony forming units) of bacteria (mentioned above) were isolated from several locations on coats before the disinfection process was performed (see Table 1, below)) and wherein the sterilization cycle visualization comprises one or more of a pie chart, a bar chart, or a graph. (Kirckof column 10 line 60-66 shows a table of different sterilization indicator cycles; Fig. 32-33 and corresponding text).
Regarding claim 16, Sunkara-Kirckof teaches the method of claim 11, wherein the first medical device processing component comprises a biological indicator analyzer; wherein providing information associated with the first and second medical device processing components to the user device comprises causing a device overview interface to display on the user device; wherein the device overview interface comprises two or more of: (i) a device identifier; (ii) a biological indicator analysis summary; (iii) an indicator well status; and (iv) an indicator analysis table. (Kirckof column 20, lines 40-60; column 15, line 15 to column 19, line 15; column 19, lines 60-68; column 20 lines 48-63).
Regarding claim 17, Sunkara-Kirckof teaches the method of claim 16, wherein the biological indicator analysis summary comprises a total number of analyses, a number of analyses per day, and a number of analyses indicating cycle success; wherein the indicator well status comprises a plurality of well indicators, each well descriptor comprising a vacancy indicator and an analyses duration indicator; and wherein the indicator analysis table comprises a set of rows, each row corresponding to a single biological indicator analysis performed by the indicator analyzer. (Kirckof column 2 lines 27-35; column 10 line 60-66; column 20 lines 48-63).
Regarding claim 18, Sunkara-Kirckof teaches the method of claim 11, wherein providing information associated with the first and second medical device processing components to the user device comprises causing a device overview interface to display on the user device; wherein the device overview interface comprises two or more of:(i) a device identifier; (ii) a biological indicator analysis summary; (iii) an indicator well status; and (iv) an indicator analysis table. (Kirckof column 20, lines 40-60; column 15, line 15 to column 19, line 15; column 19, lines 60-68; column 20 lines 48-63).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sunkara-Kirckof in view of Skaaksrud (US 2015/0154370).
Regarding claim 13, Sunkara-Kirckof teaches the method of claim 12, but does not appear to teach the following, however, Skaaksrud teaches it is old and well known in the art of data processing wherein the connection interface is configured to provide to the communication hub:(i) a network location identifier, a username, and a password; or (ii) a network pairing code. (Skaaksrud [0263], [0270], [1359] teaches using a network pairing code to secure nodes of the network)
Therefore, it would have been obvious to one of ordinary skill in the art of data processing, before the effective filing date of the claimed invention, to modify Sunkara-Kirckof, as modified above, to incorporate wherein the connection interface is configured to provide to the communication hub:(i) a network location identifier, a username, and a password; or (ii) a network pairing code, as taught by Skaaksrud, in order to pair nodes of a network and monitor medical equipment operations via the node ID. See Skaaksrud [1359].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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