DETAILED ACTION
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.
This Office Action is in response to the communication filed on 02/03/2026.
Claims 4, 6, and 13 have been canceled.
Claims 1, 3, 7-10, 12, 15, 17-20 have been amended.
Claims 1-3, 5, 7-12, and 14-20 are pending for consideration.
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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 5, 7-12, and 14-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the 112 2nd rejection of claim 1, Applicant has amended the claim. Therefore, the rejection has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 teaches the use of a ”gateway server” receiving a request for activation, generating a unique identifier in response to the request for activation, transmitting the unique identifier to the infusion pump, and validating a user input to determine activation between the infusion pump and user device. The specification teaches a server connected to a gateway device, but it does not teach a “gateway server”.
Examiner Request
The Applicant is requested to indicate where in the specification there is support for amendments to claims should Applicant amend. The purpose of this is to reduce the potential 35 U.S.C. 112(a) or 112 1st paragraph issues that can arise when claims are amended without support in the specification. The Examiner thanks the Applicant in advance.
Allowable Subject Matter
Claims 7, 16, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claims 1-3, 5, 8-12, 14-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over unpatentable over Neff (U.S. 9,218,455) (hereinafter Neff), in view of Mooney et al. (U.S.11,887,716) (hereinafter Mooney), and in further view of Jung et al. (US 2024/0416033) (hereinafter Jung).
Regarding claims 1, 9, and 18, Neff teaches receiving, by a gateway server and from a user device associated with a user, a request for activation of the infusion pump, wherein the gateway server, user device and infusion pump are in electronic communication with one another(Neff: see FIG. 1 item 10; Col 8 line 67 - Col 9 lines 1-3, "In one embodiment, Application 34 operates on a computer in a medical device and the display resides on the medical device (e.g., an infusion pump). In step 775, Application 34 communicates a request for the bar code to a remote system (processor 30)");
generating, by the gateway server, a first unique identifier responsive to receiving the request, the first unique identifier comprising at least one of a graphical symbol or an alphanumeric character (Neff: see Col 7 lines 43-46, "In step 309, processor 30 generates a unique bar code or retrieves the unique bar code from storage and sends the unique bar code associated with the received ULID to Application 34 via interface 19");
transmitting, by the gateway server and to the infusion pump, an indication of the first unique identifier to cause the infusion pump to present a graphical representation associated with the first unique identifier via a user interface (Neff: see Column 13 lines 7-9, "The medical application requests the barcode for dynamically linking a smart phone. In response, the barcode server provides a bar code"; Col 13 lines 35-40, "The communications are used to extract or parse the session ID, address, or other communications information unique to the instance of the medical application. For example, the server transmits the barcode to be used to the instance in response to a request for the barcode from the instance");
receiving, by the gateway server and from the user device, a user input comprising an input identifier indicating a user selection from the set of graphical representations (Neff: see Col 10 lines 30-37, " The interface 19 establishes communications in any format (e.g., TCP/IP) between the server 30 and the computer 12 or application 34. The interface 19 provides for two way communications. The unique one time barcode used in the assigned spot in the application screen/workflow may be transmitted from the server 30 to the computer 12, or identifying information may be transmitted from the application 34 on the computer 12 to the server 30"; Col 10 lines 45-49, "The server 30 receives identifying information and sensor data from the smart phones 32. For example, image data captured by the smart phone 32 and identifying information also captured by the smart phone 32 from the display 14 is received by the server 30");
validating, by the gateway server, the user input by comparing the input identifier to the first unique identifier, wherein the user input is validated responsive to a match between the input identifier and the first unique identifier (Neff: see Col 15 lines 31-36, "As another example, the processor 16 transmits identification information (e.g., a patient number, a screen shot, or both) for an instance of the application to the server 30. The identification information from the processor 16 may be used by the server 30 for matching with a picture or other data captured by the smart phone 32 on the display 14").
However, Neff fails to teach a first user input including user login credentials; presenting a set of graphical representations associated with the first unique identifier via a user interface; transmitting, by the gateway server and to the user device, an initial set of parameters for an infusion therapy to be performed by the infusion pump; receiving, by the gateway server and from the user device, a second user input confirming the initial set of parameters; and activating, based on the initial set of parameters and responsive to receiving the second user input, the infusion pump responsive to the validation of the user input, the infusion pump.
Nevertheless, Mooney-which is in the same field of endeavor- teaches a first user input including user login credentials (Mooney: see Col 14 lines 44-53, “In some implementations, the master infusion device may include one or more authentication features to allow the clinician access to the server 126, and to prevent the user from accessing the server 126. For example, the authentication features may include a user name and password, a badge scan, a fingerprint scan or a retina scan, and/or the use of facial recognition to identify the clinician, to provide access, via the master infusion device, to retrieve and/or alter one or more aspects of the fluid delivery protocols from the server 126”);
transmitting, by the gateway server and to the user device, an initial set of parameters for an infusion therapy to be performed by the infusion pump (Mooney: see Col 14 lines 31-36, " At 602, the master infusion device (e.g., the master infusion pump 110 and/or the user device 130 such as the app) may receive, from a server (e.g., the server 126), at least one fluid delivery protocol. The fluid delivery protocol may include one or more parameters for delivering a fluid to a user");
receiving, by the gateway server and from the user device, a second user input confirming the initial set of parameters (Mooney: see Col 14 lines 41-53, "In some implementations, the master infusion device receives a selection by a clinician or other authorized individual, via a user interface of the master infusion device, of the desired fluid delivery protocol. In some implementations, the master infusion device may include one or more authentication features to allow the clinician access to the server 126, and to prevent the user from accessing the server 126. For example, the authentication features may include a user name and password, a badge scan, a fingerprint scan or a retina scan, and/or the use of facial recognition to identify the clinician, to provide access, via the master infusion device, to retrieve and/or alter one or more aspects of the fluid delivery protocols from the server 126");
activating, based on the initial set of parameters and responsive to receiving the second user input, the infusion pump responsive to the validation of the user input, the infusion pump (Mooney: see Col 8 lines 17-30, “In some implementations, the master infusion pump 110 may be operated by the clinician 165 to retrieve the one or more fluid delivery protocols from the server 126. Additionally and/or alternatively, the app of the user device 130 may be operated by the clinician 165 to retrieve the one or more fluid delivery protocols from the server 126. To ensure that the user 160 is unable to retrieve and/or alter the one or more fluid delivery protocols via the app, the app may include one or more authentication features (such as via communication with an authorization API 652 as shown in FIG. 6) to allow the clinician 165 access to the server 126, and to prevent the user 160 from accessing certain features (e.g., the retrieval and/or altering of a fluid delivery protocol) of the app”).
Neff and Mooney are analogous art because they are from the same field of endeavor. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine Neff’s intermediary server used for pairing a medical device and a personal device with Mooney’s multi-factor authentication prior to administering fluid protocols. Mooney does not explicitly teach the use of the “confirmation” of the initial set of parameters. However, the combination of Mooney’s requirement of a multi-factor authentication prior to administering fluid protocols with Neff’s display and match authentication scheme would increase the security posture of the system and allow the system to be scalable with other types of personal or medical devices.
However, Neff and Mooney fail to teach presenting a set of graphical representations associated with the first unique identifier via a user interface.
Nevertheless, Jung-which is in the same field of endeavor- teaches presenting a set of graphical representations associated with the first unique identifier via a user interface (Jung: see Figs 5A-5C; Page 3 paragraph 0028, “In the embodiment of FIG. 5B, rather than selectable color objects 206, the pairing screen 202B displays a plurality of selectable pump objects 204 displaying different color combinations (e.g., blue/white, red/red, red/blue, etc.) and the user is instructed to select the pump object 204 that matches the indicator lights 174 on the pump a specific number of times (i.e., 8 times)”).
Neff, Mooney, and Jung are analogous art because they are from the same field of endeavor. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to utilize Jung’s display of multiple authentication/pairing images with the system of Neff and Mooney. The suggestion/motivation for doing so would be to prevent mis-pairing of the devices, and decrease the amount of human-errors that may occur with typical systems that utilize schemes such as username and password.
Regarding claims 2 and 12, Neff, Mooney, and Jung teach the user input indicating the input identifier comprises one of: i) a user selection from a set of possible identifiers, ii) a string of alphanumeric characters entered into a text field by the user, or iii) an image of the first unique identifier captured by a camera of the user device (Jung: see Page 4 paragraph 0034 lines 1-8, "In some embodiments, the indicator lights on the pump can be employed to correspond with a number for a pairing code. For example, a sequence may occur where a pump first blinks three times requiring the user to input the number “3” into the pairing screen, followed by, e.g., the light blinking two times, then one time, then 5 times for a pairing code of 3-2-1-5 (although a code of any number of digits could be used)"). Motivation to combine Neff, Mooney, and Jung, in the instant claim, is the same as that in claim 1.
Regarding claim 3, Neff, Mooney, and Jung teach the user input includes the set of possible identifiers, and wherein each identifier of the set of identifiers comprises a unique graphical symbol (Jung: see FIG. 5B item 204; Page 9 lines 10-14, "Referring to Figure 5A, pairing screen 202A can include a pump icon 204 and a plurality of selectable color objects 206 (for example, red, blue, yellow and white or off objects). The screen can include instructions for the user to look at the actual indicator lights 174 on the user’s pump and to select the color objects 206 corresponding to the colors displayed by the indicator lights"). Motivation to combine Neff, Mooney, and Jung, in the instant claim, is the same as that in claim 1.
Regarding claims 5 and 14, Neff, Mooney, and Jung teach the representation of the first unique identifier is presented as a digital image on the user interface of the infusion pump (Jung: see Figs. 5A-5F; Page 3 paragraph 0028, “FIG. 5F depicts another pairing screen 202F that does not require color. In this embodiment, either both lights are on, both lights are off, or one of the two lights is on and the user selects the matching image on the screen for each pattern in the sequence”. Motivation to combine Neff, Mooney, and Jung, in the instant claim, is the same as that in claim 1.
Regarding claims 8 and 17, Neff, Mooney, and Jung teach the second user input comprises a modification of at least one parameter of the initial set of parameters (Mooney: see Col 16 lines 48-53, “At 614, the user device may transmit at least one of the measured and/or logged parameters associated with the delivery of the fluid to the server (e.g., directly to the server). The transmitted measured and/or logged parameters may be used by the server to update one or more medical records of the user, and/or to alert the clinician at the medical facility”). Motivation to combine Neff, Mooney, and Jung, in the instant claim, is the same as that in claim 1.
Regarding claim 10, Neff, Mooney, and Jung teach the first unique identifier comprises one of: i) a graphical symbol, ii) a machine-readable code, or iii) a string of alphanumeric characters (Jung: see FIG. 5B item 204; Page 9 lines 10-14, "Referring to Figure 5A, pairing screen 202A can include a pump icon 204 and a plurality of selectable color objects 206 (for example, red, blue, yellow and white or off objects). The screen can include instructions for the user to look at the actual indicator lights 174 on the user’s pump and to select the color objects 206 corresponding to the colors displayed by the indicator lights"). Motivation to combine Neff, Mooney, and Jung in the instant claim, is the same as that in claim 1.
Regarding claim 11, Neff, Mooney, and Jung teach receiving, from a user device associated with a user and prior to generating the first unique identifier, a second user input requesting activation of the infusion pump (Jung: see Page 5 paragraph 0040 lines 4-6, "receiving input at the remote control device to initiate a pairing procedure for pairing the remote control device with the user-wearable infusion pump"). Motivation to combine Neff, Mooney, and Jung in the instant claim, is the same as that in claim 1.
Regarding claims 15 and 19, Neff, Mooney, and Jung teach receiving, from a user device and prior to activating the infusion pump, a second user input comprising one or more parameters for an infusion therapy to be performed by the infusion pump, wherein the infusion pump is operated according the to the one or more parameters upon activation (Mooney: see Col 2 lines 14-16, "In some aspects, the receiving further includes authenticating a clinician to provide access to the fluid delivery protocol on the server"; Col 6 lines 24-28, "The app may also provide the clinician 165 with functionality to select one or more sets of properties or parameters of the fluid delivery protocols transmitted to the slave infusion pump 150"). Motivation to combine Neff, Mooney, and Jung in the instant claim, is the same as that in claim 1.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELAH JANAE MCFARLAND-BARNES whose telephone number is (571)272-5953. The examiner can normally be reached Monday through Friday 8:00am until 4:00pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lynn D Feild can be reached at 571-272-2092. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KELAH JANAE MCFARLAND-BARNES/Examiner, Art Unit 2431
/LYNN D FEILD/Supervisory Patent Examiner, Art Unit 2431
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