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 .
Response to Amendment
The amendment filed 10/16/2025 has been entered. Claims 1-40 are pending in the application.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 10 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rosinko (US 2018/0021514).
Regarding Claim 10, Rosinko discloses a device (12, Fig 1) for controlling the delivery of a medication to a patient's body (Para 0001), comprising a controller (42, Fig 2) connected to a medical device and configured to control delivery of medication from the medical device to a patient's body (Para 0023); and a graphical user interface (GUI) display (60, Fig 3) connected to the controller and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0024); wherein the controller is configured to generate at least two screens comprising a first screen (88, Fig 10A) and a second screen (81, Fig 6B) to perform a single controller operation chosen from: (a) unlocking the GUI; and (b) controlling a designated operation by the medical device that is different from the (a) unlocking the GUI (Para 0032; confirmation screen 88 is displayed after entering a bolus value and before second confirmation screen 81); wherein, for the (b) controlling the designated operation by the medical device, the controller is configured to send display commands to the GUI display to generate the first screen having a swipe field over which a user's finger is swiped to receive a user finger swipe gesture and having no moving icons related to the user finger swipe gesture, the swipe field being displayed to prompt a user to initiate the designated operation by the medical device (Para 0036, alternative to tracing, swiping can be relied on to initiate the designated operation; Para 0032, Instruction text 164 can prompt a user to swipe); wherein the controller is configured to generate the second screen when it has determined from data, which relates to the user finger swipe gesture and is received from GUI display, that the user finger swipe gesture has traversed a selected amount of the swipe field and in a designated direction along the swipe field to be recognized by the controller as a valid swipe gesture; and wherein the second screen comprises a confirm button (142, Fig 6B) that requires a valid user press before the controller undertakes the designated operation, the controller generating and sending a command for the designated operation to the medical device when the controller determines that a valid user press has been inputted to the confirm button (Para 0028, 0032; Screen 88 can replace the first confirmation screen 80 and thus, when the confirmation gesture is inputted, the second confirmation screen 81 with the confirmation button 142 is display. Pressing the confirmation button results in the delivery of the drug).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Walsh (US 2014/0276531) and further in view of Aalto-Setala (US 2009/0209938).
Regarding claim 1, Rosinko discloses a system for delivery of a medication to a patient's body (Para 0001), comprising: a medical device (12, Fig 1) configured to deliver a medication to a patient's body; a controller (42, Fig 2) connected to the medical device and configured to control delivery of medication from the medical device to a patient's body (Para 0023); and a graphical user interface (GUI) display (60, Fig 3) connected to the controller and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0024); wherein the controller is configured to control the GUI to generate at least two screens comprising a first screen (88, Fig 10A) and a second screen (81, Fig 6B) to perform a single controller operation chosen from: (a) unlocking the GUI; and (b) controlling a designated operation by the medical device that is different from the (a) unlocking the GUI (Para 0032; confirmation screen 88 is displayed after entering a bolus value and before second confirmation screen 81); wherein, for the (b) controlling the designated operation by the medical device, the controller is configured to send display commands to the GUI display to generate the first screen having a swipe field over which a user's finger is swiped to receive a user finger swipe gesture and having no moving icons related to the user finger swipe gesture, the swipe field being displayed to prompt a user to initiate the designated operation by the medical device (Para 0036; alternative to tracing, swiping can be relied on to initiate the designated operation), send display commands to the GUI display to generate the second screen when the controller has determined from data, which relates to the user finger swipe gesture and is received from the GUI display, that the user finger swipe gesture has traversed a selected amount of the swipe field and in a designated direction along the swipe field to be recognized by the controller as a valid swipe gesture, and generate and send a command for the designated operation to the medical device when the controller determines that a valid user press has been inputted to a confirm button (142, Fig 6B) on the second screen; wherein, when the designated operation is delivery of the medication and the controller determines a valid user press has been inputted to the confirm button on the second screen, the controller is configured to command the medical device to initiate delivery of the medication to the patient (Para 0028).
Rosinko is silent regarding the controller is configured generate a delivery status screen via the GUI display, the delivery status screen comprising a rotating progress ring symbol and a level indicator, the controller transitioning each of the rotating progress ring symbol and the level indicator in accordance with a selected event related to the delivery of the medication.
Walsh discloses an analogous system for delivery of a medication to a patient's body, comprising: a medical device (12, Fig 1) configured to deliver a medication to a patient's body (Para 0001); a controller (42, Fig 2) connected to the medical device and configured to control delivery of medication from the medical device to a patient's body (Para 0022); and a graphical user interface (GUI) display (60, Fig 2) connected to the controller and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0023); wherein the controller is configured to command the medical device to initiate delivery of the medication to the patient (Para 0034), and to generate a delivery status screen via the GUI display, the delivery status screen comprising a level indicator (94, Fig 4) (Para 0025), the controller transitioning the level indicator in accordance with a selected event related to the delivery of the medication (Para0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to be configured to generate a level indicator as taught by Walsh in order to provide feedback to the user as to how much of the bolus has been delivered to the user
The modified invention Rosinko and Walsh discloses all of the elements of the invention as discussed above, however, is silent regarding a rotating progress ring symbol; and the controller transitioning the rotating progress ring symbol in accordance with a selected event related to the delivery of the medication.
Aalto-Setala teaches a graphical user interface (GUI) display (11, Fig 1) and a controller configured to generate a delivery status screen (Screen seen in Fig 2) via the GUI display, the delivery status screen comprising a rotating progress ring symbol (15, Fig 2), the controller transitioning the rotating progress ring symbol in accordance with a selected event related to the delivery of the medication (Para 0116-0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to be configured to generate a rotating progress ring symbol as taught by Aalto-Setala in order to indicate, at a glance, that the pump is working which ensures that an even and continuous dosing of insulin is being delivered to the user (Para 0117).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Walsh (US 2014/0276531) and further in view of Aalto-Setala (US 2009/0209938) and further in view of Mesguich (US 2014/0331175).
Regarding claim 2, the modified invention Rosinko, Walsh, and Aalto-Setala discloses all of the elements of the invention as discussed above, however is silent regarding the user press in the confirm button must occur within a selected time interval after display of the second screen is initiated on the GUI display to be recognized by the controller as a valid user press .
Mesguich teaches a confirmation input must occur within a selected time interval after display of the screen is initiated on the GUI display to be recognized by the controller as a valid user press (Para 0017, 0027; the input must be received within, for example, 5 seconds before the operation is abandoned).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to have a time out feature for the user press as taught by Mesguich in order to ensure that the user intends to perform the function (Para 0027).
Claims 3 and 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Walsh (US 2014/0276531) and further in view of Aalto-Setala (US 2009/0209938) and further in view of Allen (US 2012/0200514).
Regarding claim 3, the modified invention Rosinko, Walsh, and Aalto-Setala discloses that the first screen can be a swipe to start delivery screen with instruction text (164, Fig 10A -Rosinko)(Para 0036 -Rosinko), however is silent regarding the first screen displays alphanumeric screen identifying information indicating the first screen is a swipe to start delivery screen for the controller, and graphical information indicating the designated direction of the valid swipe gesture.
Allen teaches a medical device comprising a graphical user interface display (142, Fig 3) connected to a controller (“control circuitry”) and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0026); wherein the controller is configured to send display commands to the GUI display to generate a screen (Screen seen in Fig 3) having a swipe field (204, Fig 3) over which a user's finger is swiped to receive a user finger swipe gesture; wherein screen displays alphanumeric screen identifying information (206, Fig 3) indicating the first screen is a swipe to start screen for the controller, and graphical information (205, Fig 3) indicating the designated direction of the valid swipe gesture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to generate a first screen displaying alphanumeric screen identifying information and graphical information indicating the designated direction as taught by Allen in order to indicate to the user the action that needs to be performed to confirm the function (Para 0031).
Regarding claim 5, the modified invention Rosinko, Walsh, and Aalto-Setala discloses all of the elements of the invention as discussed above, however is silent regarding the controller is configured to also perform the (a) unlocking the GUI and to send a display command to the GUI display to display a third screen that is a locked screen having another swipe field over which a user's finger is swiped to receive another user finger swipe gesture and having no moving icons in the another swipe field related to the another user finger swipe gesture, the another swipe field being displayed to prompt a user to initiate unlocking the locked screen.
Allen teaches a medical device comprising a graphical user interface display (142, Fig 3) connected to a controller (“control circuitry”) and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0026); wherein the controller is configured to also perform the (a) unlocking the GUI and to send a display command to the GUI display to display a third screen (Screen seen in Fig 3) that is a locked screen having another swipe field (204, Fig 3) over which a user's finger is swiped to receive another user finger swipe gesture and having no moving icons in the another swipe field related to the another user finger swipe gesture (Para 0031 -Allen; the arrow icon and text are stationary within the swipe field 204), the another swipe field being displayed to prompt a user to initiate unlocking the locked screen (Para 0033-0034 -Allen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to be configured to also perform the (a) unlocking the GUI as taught by Allen in order to prevent inadvertent or accidental use of the GUI (Para 0015). Allen also notes in Para 0015 that the “swipe to unlock” feature can be implemented on any electronic device having a touch screen.
Regarding claim 7, the modified invention Rosinko, Walsh, Aalto-Setala, and Allen discloses the third screen (Screen of Fig 3 -Allen) displays alphanumeric screen identifying information (206, Fig 3 -Allen) indicating the third screen is a swipe to unlock screen for the controller, and graphical information (205, Fig 3 -Allen) indicating the designated direction of the another valid swipe gesture (Para 0031 -Allen).
Claim 4, 6, 8-9 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Walsh (US 2014/0276531) and further in view of Aalto-Setala (US 2009/0209938) and further in view of Allen (US 2012/0200514) and further in view of Bandyopadhyay (US 2012/0009896).
Regarding claim 4, the modified invention Rosinko, Walsh, Aalto-Setala, and Allen discloses the graphical information comprises a single static arrow (205, Fig 3 -Allen) pointing in the designated direction of the valid swipe gesture (Para 0031 -Allen), however, is silent regarding a series of static arrows.
Bandyopadhyay teaches an analogous first screen (Screen of Fig 5B) comprising a graphical information (arrows associated on side of icon 520, Fig 5B) indicating the designated direction of the valid swipe gesture wherein the graphical information comprises a series of static arrows pointing in the designated direction of the valid swipe gesture (See Fig 5B) (Para 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single static arrow disclosed by Allen to be a series of static arrows since Bandyopadhyay indicates that a series of arrows would perform the same function of indicating a designated direction of the valid swipe gesture (Para 0079) and it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding claim 6, the modified invention of Rosinko, Walsh, Aalto-Setala, and Allen discloses a fifth unlocked screen (120, Fig 5B -Rosinko) to allowed allow the user to commence user inputs to the GUI to operate the medical device (Para 0027 -Rosinko), however, is silent regarding the controller is configured to generate and send display commands to the GUI display to generate a fourth screen when the controller has determined from data, which relates to the another user finger swipe gesture and is received from graphical user display, that the another user finger swipe gesture has traversed a selected amount of the another swipe field and in a designated direction along the another swipe field to be recognized by the controller as another valid swipe gesture; and generate and send a command to the GUI display for generating a fifth unlocked screen.
Bandyopadhyay teaches an analogous controller configured to perform the (a) unlocking the GUI and to send a display command to the GUI display to display a third screen (screen displayed in Fig 5A) that is a locked screen having another swipe field over which a user's finger is swiped to receive another user finger swipe gesture (Para 0079), the controller is configured to generate and send display commands to the GUI display to generate a fourth screen (screen displayed in Fig 5B) when the controller has determined from data, which relates to the another user finger swipe gesture and is received from graphical user display, that the another user finger swipe gesture has traversed a selected amount of the another swipe field and in a designated direction along the another swipe field to be recognized by the controller as another valid swipe gesture; and generate and send a command to the GUI display for generating a fifth unlocked screen (Para 0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to generate a fourth screen (i.e. authentication screen) as taught by Bandyopadhyay in order to improve security and prevent unauthorized use of the device (Para 0080).
Regarding claim 8, the modified invention Rosinko, Walsh, Aalto-Setala, and Allen discloses the graphical information comprises a single static arrow (205, Fig 3 -Allen) pointing in the designated direction of the another valid swipe gesture (Para 0031 -Allen), however, is silent regarding a series of static arrows.
Bandyopadhyay teaches an analogous first screen (Screen of Fig 5B) comprising a graphical information (arrows associated on side of icon 520, Fig 5B) indicating the designated direction of the valid swipe gesture wherein the graphical information comprises a series of static arrows pointing in the designated direction of the valid swipe gesture (See Fig 5B) (Para 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single static arrow disclosed by Allen to be a series of static arrows since Bandyopadhyay indicates that a series of arrows would perform the same function of indicating a designated direction of the valid swipe gesture (Para 0079) and it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding claim 9, the modified invention Walsh, Allen, and Aalto-Setala discloses the fifth unlocked screen (120, Fig 5B -Rosinko) is a start delivery screen configured to allow a user to enter at least one of a request to deliver a dose of medication and an inputted amount of medication (Para 0027 -Rosinko), and that is followed by the first screen and the second screen that requires the user to enter a valid press of the confirm button to confirm that delivery of medication is desired (0032 -Rosinko).
Claims 10, 12, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Allen (US 2012/0200514) and further in view of Bandyopadhyay (US 2012/0009896).
Regarding Claim 10, Rosinko discloses a device (12, Fig 1) for controlling the delivery of a medication to a patient's body (Para 0001), comprising a controller (42, Fig 2) connected to a medical device and configured to control delivery of medication from the medical device to a patient's body (Para 0023); and a graphical user interface (GUI) display (60, Fig 3) connected to the controller and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0024); wherein the controller is configured to generate at least two screens (See screens displayed in Figs 3-5c)
Rosinko is silent regarding a first screen and a second screen to perform a single controller operation chosen from: (a) unlocking the GUI.
Allen teaches a medical device comprising a graphical user interface display (142, Fig 3) connected to a controller (“control circuitry”) and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0026); wherein the controller is configured to also perform the (a) unlocking the GUI and to send a display command to the GUI display to display a first screen (Screen seen in Fig 3) that is a locked screen having another swipe field (204, Fig 3) over which a user's finger is swiped to receive another user finger swipe gesture and having no moving icons in the another swipe field related to the another user finger swipe gesture (Para 0031 -Allen; the arrow icon and text are stationary within the swipe field 204), the another swipe field being displayed to prompt a user to initiate unlocking the locked screen (Para 0033-0034 -Allen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to be configured to also perform the (a) unlocking the GUI as taught by Allen in order to prevent inadvertent or accidental use of the GUI (Para 0015). Allen also notes in Para 0015 that the “swipe to unlock” feature can be implemented on any electronic device having a touch screen.
The modified invention discloses all of the elements of the invention as discussed above, however, is silent regarding a second screen for unlocking the GUI.
Bandyopadhyay teaches an analogous controller configured to perform the (a) unlocking the GUI and to send a display command to the GUI display to display a first screen (screen displayed in Fig 5A) that is a locked screen having another swipe field over which a user's finger is swiped to receive another user finger swipe gesture (Para 0079), the controller is configured to generate and send display commands to the GUI display to generate a second screen (screen displayed in Fig 5B) when the controller has determined from data, which relates to the another user finger swipe gesture and is received from graphical user display, that the another user finger swipe gesture has traversed a selected amount of the another swipe field and in a designated direction along the another swipe field to be recognized by the controller as another valid swipe gesture; and generate and send a command to the GUI display for generating a fifth unlocked screen (Para 0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to generate a fourth screen (i.e. authentication screen) as taught by Bandyopadhyay in order to improve security and prevent unauthorized use of the device (Para 0080).
Examiner notes that the wherein clause, “wherein, for the (b) controlling the designated operation by the medical device, the controller is configured to send display commands to the GUI display to generate the first screen having a swipe field over which a user's finger is swiped to receive a user finger swipe gesture and having no moving icons related to the user finger swipe gesture, the swipe field being displayed to prompt a user to initiate the designated operation by the medical device; wherein the controller is configured to generate the second screen when it has determined from data, which relates to the user finger swipe gesture and is received from GUI display, that the user finger swipe gesture has traversed a selected amount of the swipe field and in a designated direction along the swipe field to be recognized by the controller as a valid swipe gesture; and wherein the second screen comprises a confirm button that requires a valid user press before the controller undertakes the designated operation, the controller generating and sending a command for the designated operation to the medical device when the controller determines that a valid user press has been inputted to the confirm button.”, is only directed to controlling the designated operation by the medical device that is different from the (a) unlocking the GUI. Therefore, in this interpretation of the claims, the prior art references are being relied on to teach the elements of the controller for (a) unlocking the GUI. Thus, the elements for controlling the designated operation are not being considered. Further, the language of the claim 10 only requires the controller to “perform a single controller operation chosen from” the unlocking the GUI or the designated operation.
Regarding Claim 12, the modified invention of Rosinko, Allen, and Bandyopadhyay discloses the first screen (Screen seen in Fig 3 -Allen) displays alphanumeric screen identifying information (206, Fig 3 -Allen) indicating the third screen is a swipe to unlock screen for the controller, and graphical information (205, Fig 3 -Allen) indicating the designated direction of the valid swipe gesture (Para 0031 -Allen).
Regarding claim 15, the modified invention Rosinko, Allen, and Bandyopadhyay discloses the graphical information comprises a single static arrow (205, Fig 3 -Allen) pointing in the designated direction of the valid swipe gesture (Para 0031 -Allen), however, is silent regarding a series of static arrows.
Bandyopadhyay further teaches an analogous first screen (Screen of Fig 5B) comprising a graphical information (arrows associated on side of icon 520, Fig 5B) indicating the designated direction of the valid swipe gesture wherein the graphical information comprises a series of static arrows pointing in the designated direction of the valid swipe gesture (See Fig 5B) (Para 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single static arrow disclosed by Allen to be a series of static arrows since Bandyopadhyay indicates that a series of arrows would perform the same function of indicating a designated direction of the valid swipe gesture (Para 0079) and it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding Claim 16, the modified invention Rosinko, Allen, and Bandyopadhyay discloses the controller sends a display command to the GUI to generate a third screen (120, Fig 5B -Rosinko) when a valid user press is recognized in the second screen (screen displayed in Fig 5B - Bandyopadhyay), the third screen being configured to allow a user to enter at least one of a request to deliver a dose of medication and an inputted amount of medication (Para 0027 -Rosinko), and to require the user to enter another valid press (“Enter”, Fig 5B -Rosinko) of a button on the third screen to confirm that delivery of medication is desired (Para 0027 -Rosinko).
Regarding Claim 17, the modified invention Rosinko, Allen, and Bandyopadhyay discloses the controller generates the first screen (Screen seen in Fig 3) when the another valid press is recognized of the button on the third screen to confirm that delivery of medication is desired (the lock screen can be generated at any point after the button is pressed if there is no input for the designated amount of time as described in Para 0028 -Allen); wherein the controller is configured to generate the second screen (screen displayed in Fig 5B - Bandyopadhyay) when it has determined from data, which relates to the user finger swipe gesture and is received from the GUI display, that the user finger swipe gesture has traversed a selected amount of the swipe field and in a designated direction along the swipe field to be recognized by the controller as a valid swipe gesture (Para 0079-0080 - Bandyopadhyay); and wherein the first screen remains displayed by the GUI display and the second screen is not generated when the controller determines that either the user finger swipe gesture has not traversed a selected amount of the swipe field or was in a direction along the swipe field other than the designated direction of the swipe field (Para 0034 -Allen).
Regarding Claim 18, the modified invention Rosinko, Allen, and Bandyopadhyay discloses the first screen remains displayed by the GUI display and the second screen is not generated when the controller determines that either the user finger swipe gesture has not traversed a selected amount of the swipe field or was in a direction along the swipe field other than the designated direction (Para 0034 -Allen).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Mesguich (US 2014/0331175).
Regarding claim 11, Rosinko discloses all of the elements of the invention as discussed above, however is silent regarding the user press in the confirm button must occur within a selected time interval after display of the second screen is initiated on the GUI display to be recognized by the controller as a valid user press .
Mesguich teaches a confirmation input must occur within a selected time interval after display of the screen is initiated on the GUI display to be recognized by the controller as a valid user press (Para 0017, 0027; the input must be received within, for example, 5 seconds before the operation is abandoned).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to have a time out feature for the user press as taught by Mesguich in order to ensure that the user intends to perform the function (Para 0027).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Allen (US 2012/0200514) and further in view of Bandyopadhyay (US 2012/0009896).
Regarding claim 13, the modified invention Rosinko, Allen, and Bandyopadhyay discloses the graphical information comprises a single static arrow (205, Fig 3 -Allen) pointing in the designated direction of the valid swipe gesture (Para 0031 -Allen), however, is silent regarding a series of static arrows.
Bandyopadhyay further teaches an analogous first screen (Screen of Fig 5B) comprising a graphical information (arrows associated on side of icon 520, Fig 5B) indicating the designated direction of the valid swipe gesture wherein the graphical information comprises a series of static arrows pointing in the designated direction of the valid swipe gesture (See Fig 5B) (Para 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single static arrow disclosed by Allen to be a series of static arrows since Bandyopadhyay indicates that a series of arrows would perform the same function of indicating a designated direction of the valid swipe gesture (Para 0079) and it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Allen (US 2012/0200514).
Regarding claim 14, Rosinko discloses that the first screen can be a swipe to start delivery screen with instruction text (164, Fig 10A)(Para 0036), however is silent regarding the first screen displays alphanumeric screen identifying information indicating the first screen is a swipe to start delivery screen for the controller, and graphical information indicating the designated direction of the valid swipe gesture.
Allen teaches a medical device comprising a graphical user interface display (142, Fig 3) connected to a controller (“control circuitry”) and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0026); wherein the controller is configured to send display commands to the GUI display to generate a screen (Screen seen in Fig 3) having a swipe field (204, Fig 3) over which a user's finger is swiped to receive a user finger swipe gesture; wherein screen displays alphanumeric screen identifying information (206, Fig 3) indicating the first screen is a swipe to start screen for the controller, and graphical information (205, Fig 3) indicating the designated direction of the valid swipe gesture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to generate a first screen displaying alphanumeric screen identifying information and graphical information indicating the designated direction as taught by Allen in order to indicate to the user the action that needs to be performed to confirm the function (Para 0031).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Allen (US 2012/0200514) and further in view of Bandyopadhyay (US 2012/0009896).
Regarding Claim 19, Rosinko discloses a fifth unlocked screen (120, Fig 5B -Rosinko) to allowed allow the user to commence user inputs to the GUI to operate the medical device (Para 0027 -Rosinko), however is silent regarding the controller is configured to also perform the (a)unlocking the GUI, and to send display commands to the GUI display to generate a third screen that is a locked screen having another swipe field over which a user's finger is swiped to receive another user finger swipe gesture and having no moving icons in the another swipe field related to the another user finger swipe gesture, the another swipe field being displayed to prompt a user to initiate unlocking the locked screen; generate a fourth screen when the controller has determined from data, which relates to the another user finger swipe gesture and is received from graphical user display, that the another user finger swipe gesture has traversed a selected amount of the another swipe field and in a designated direction along the another swipe field to be recognized by the controller as another valid swipe gesture.
Allen teaches a medical device comprising a graphical user interface display (142, Fig 3) connected to a controller (“control circuitry”) and configured to receive user inputs and provide data relating to the user inputs to the controller and to generate display screens in response to display commands from the controller (Para 0026); wherein the controller is configured to also perform the (a) unlocking the GUI and to send a display command to the GUI display to display a third screen (Screen seen in Fig 3) that is a locked screen having another swipe field (204, Fig 3) over which a user's finger is swiped to receive another user finger swipe gesture and having no moving icons in the another swipe field related to the another user finger swipe gesture (Para 0031 -Allen; the arrow icon and text are stationary within the swipe field 204), the another swipe field being displayed to prompt a user to initiate unlocking the locked screen (Para 0033-0034 -Allen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to be configured to also perform the (a) unlocking the GUI as taught by Allen in order to prevent inadvertent or accidental use of the GUI (Para 0015). Allen also notes in Para 0015 that the “swipe to unlock” feature can be implemented on any electronic device having a touch screen.
The modified invention of Rosinko and Allen is silent regarding the controller is configured to generate and send display commands to the GUI display to generate a fourth screen when the controller has determined from data, which relates to the another user finger swipe gesture and is received from graphical user display, that the another user finger swipe gesture has traversed a selected amount of the another swipe field and in a designated direction along the another swipe field to be recognized by the controller as another valid swipe gesture; and generate and send a command to the GUI display for generating a fifth unlocked screen.
Bandyopadhyay teaches an analogous controller configured to perform the (a) unlocking the GUI and to send a display command to the GUI display to display a third screen (screen displayed in Fig 5A) that is a locked screen having another swipe field over which a user's finger is swiped to receive another user finger swipe gesture (Para 0079), the controller is configured to generate and send display commands to the GUI display to generate a fourth screen (screen displayed in Fig 5B) when the controller has determined from data, which relates to the another user finger swipe gesture and is received from graphical user display, that the another user finger swipe gesture has traversed a selected amount of the another swipe field and in a designated direction along the another swipe field to be recognized by the controller as another valid swipe gesture; and generate and send a command to the GUI display for generating a fifth unlocked screen (Para 0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to generate a fourth screen (i.e. authentication screen) as taught by Bandyopadhyay in order to improve security and prevent unauthorized use of the device (Para 0080).
Claims 20-22, 25, 32-33, 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Walsh (US 2014/0276531) in view of Aalto-Setala (US 2009/0209938) and further in view of My Water (“My Water: Daily Drink Tracker”).
Regarding claim 20, Walsh discloses a device (12, Fig 1) for controlling the delivery of a medication to a patient's body (Para 0001), comprising a controller (42, Fig 2) connected to a medical device (20, 16, 48, 40, 30, 32, 34, Fig 2) and configured to control delivery of medication from the medical device to a patient's body (Para 0022); a user interface (46, Fig 2) connected to the controller and configured to receive user inputs and provide data relating to the user inputs to the controller (Para 0023); and a display (44, Fig 1) connected to the controller and configured to generate display screens (Para 0017); wherein the controller is configured to command the medical device to initiate delivery of the medication to the patient in response to a user input via the user interface (Para 0034), and to generate a delivery status screen (screen having bolus object 82 of Fig 4) via the display in response to the user input; wherein the delivery status screen comprises a level indicator (92 and 94, Fig 4) (Para 0025), the controller transitioning the level indicator in accordance with a selected event related to the delivery of the medication (Para 0025); and wherein the level indicator comprises a transition line delineating a background image (“the color on one side”) of the delivery status screen and a background gradient image (“a different color”), and the controller is configured to control movement of the transition line in the delivery status screen to vary the size of the background gradient image displayed relative to the background image, the controller being configured to automatically and incrementally move the transition line and thereby change relative sizes of the respective portions of the background image and the background gradient image during delivery of the medication based on the selected event, the selected event being chosen from amount of the medication being delivered and amount of time elapsed during the delivery of the medication (Para 0026).
Walsh is silent regarding each of the display screens constituting a defined area on the display; respective portions of the background image and the background gradient image combined constitute an entirety of the delivery status screen generated on the display; a rotating progress ring symbol; the controller transitioning the rotating progress ring symbol in accordance with a selected event related to the delivery of the medication.
Aalto-Setala teaches a graphical user interface (GUI) display (11, Fig 1) and a controller configured to generate a delivery status screen (Screen seen in Fig 2) via the GUI display, the delivery status screen comprising a rotating progress ring symbol (15, Fig 2), the controller transitioning the rotating progress ring symbol in accordance with a selected event related to the delivery of the medication (Para 0116-0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to be configured to generate a rotating progress ring symbol as taught by Aalto-Setala in order to indicate to the user, at a glance, that the pump is working (Para 0117).
The modified invention of Walsh and Aalto-Setala discloses all of the elements of the invention as discussed above, however, is silent regarding each of the display screens constituting a defined area on the display; respective portions of the background image and the background gradient image combined constitute the defined area on the display.
My Water discloses a graphical user interface (GUI) displaying a level indicator comprising a transition line delineating a background image (light color area) of the screen and a background gradient image (darker fill color) whereby respective portions of the background image and the background gradient image combined constitute an entirety of the delivery status screen generated (See pages 1 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the level indicator disclosed by Walsh to be a full screen level indicator as taught by My Water as Walsh teaches that the level indicator can be portrayed to the user in various configurations (Para 0025). Further, in Para 0070 of the instant specification, it is indicated that other types of level indicators can be used and therefore, there is no specific criticality to the claimed level indicator design. It has been held that a mere matter of design choice is unpatentable as a person of ordinary skill in the art would have found it obvious absent persuasive evidence that the particular claimed configuration was significant (See MPEP 2144.04(IV)(B); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Regarding claim 21, the modified invention of Walsh Aalto-Setala, and My Water discloses the controller (42, Fig 2 -Walsh as modified by Aalto-Setala) and the medical device (48, Fig 2 -Walsh) exchange messages (Para 0018-0019 -Walsh; 0114 and 0117 -Aalto-Setala), the medical device advising the controller of status of completion of the delivery of the medication, and the controller using the status of completion as the selected event for transitioning each of the rotating progress ring symbol and the level indicator (Para 0117 -Aalto-Setala; monitoring of the pump by sensors 21 is communicated to the controller and results in the updating of the ring symbol 15 and level indicators, 14 and 18).
Regarding claim 22, the modified invention of Walsh, Aalto-Setala, and My Water discloses the status of completion comprises number of units of the medication delivered to the patient’s body (Para 0025 -Walsh).
Regarding claim 25, the modified invention of Walsh, Aalto-Setala, and My Water discloses the controller changes the position of the level indicator relative to the background image in the delivery status screen to display a selected amount of the background gradient image to correspond to a selected change in the units of the medication delivered to the patient's body (Para 0025-0026 -Walsh).
Regarding claim 32, the modified invention of Walsh, Aalto-Setala, and My Water discloses the user interface (46, Fig 2 -Walsh) and the display (44, Fig 2 -Walsh) are configured in a graphical user interface (GUI) device (60, Fig 2 -Walsh)
Regarding claim 33, the modified invention of Walsh, Aalto-Setala, and My Water discloses the GUI device (60, Fig 2 -Walsh) is on the controller (42, Fig 2) (As seen in Fig 1, the GUI device (44 and 46) is on the top surface of the housing 26 while the controller 42 is interior to the housing. Thus, the GUI device is at least in a plane, created by the surface of the housing 26, that is on top of a plane where the controller exists within the housing; the claim does not specify that the GUI device must be on a controller separate from the medical device as described in the specification).
Regarding claim 35, the modified invention of Walsh, Aalto-Setala, and My Water discloses the background image of the delivery status screen and the background gradient image are generated using two different colors (Para 0025-0026 -Walsh).
Regarding claim 36, The modified invention of Walsh, Aalto-Setala, and My Water discloses the progress ring is superimposed on the respective portions of the background image and the background gradient image that combined constitute entirety of the delivery status screen generated on the display such that the progress ring is displayed in the defined area of the display wherein the level indicator is moved to alter the amount the background gradient image that is displayed relative to the background image (Para 0025-0026 -Walsh; Para 0117 -Aalto-Setala; As My Water teaches that the level indicator is on an entirety of the screen with other elements superimposed on it (See the percentage and “add drink” button superimposed on the screen of page 1 of My Water), then the modified invention would have the progress wheel superimposed.)
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Walsh (US 2014/0276531) in view of Aalto-Setala (US 2009/0209938) and further in view of My Water (“My Water: Daily Drink Tracker”) and further in view of Hickle (US 2003/0135087).
Regarding claim 23, the modified invention of Walsh, Allen, Aalto-Setala, and My Water discloses all of the elements of the invention as discussed above, however, is silent regarding the controller rotates the progress ring symbol a selected number of degrees corresponding to a selected change in the units of the medication delivered to the patient's body.
Hickle teaches a rotating progress ring symbol (76e, Fig 12) wherein the controller rotates the progress ring symbol a selected number of degrees corresponding to a selected change in the units of the medication delivered to the patient's body (Para 0102 and Para 0142; the rate of rotation correlates to the rate of delivery of the medicament).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to rotate the rotating progress ring symbol a selected number of degrees that correspond to the change in the units of the medication delivered to the patient's body as taught by Hickle in order to graphically indicate the current flow rate of medication to the user (Par 0102)
Regarding claim 24, the modified invention of Walsh, Aalto-Setala, My Water, and Hickle disclose the progress ring symbol (15, Fig 2 -Aalto-Setala) comprises at least one of a notch (See annotated Fig 2 below) along its circumference or a gradient in the thickness of the progress ring symbol to facilitate user discernment of rotation of the progress symbol.
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Claims 26, 29, and 34 are rejected under 35 U.S.C. 103 as being unpatentable Walsh (US 2014/0276531) in view of Aalto-Setala (US 2009/0209938) and further in view of My Water (“My Water: Daily Drink Tracker”) and further in view of Alme (US 2010/0185182).
Regarding claim 26, the modified invention of Walsh, Aalto-Setala, and My water discloses the controller determines status of completion of the delivery of the medication based on a timer initiated at the initiation of the delivery of the medication, the controller using the amount of time elapsed indicated by the timer as the selected event for transitioning each of the rotating progress ring symbol and the level indicator.
Alme teaches an analogous invention directed to a system (Fig. 1) comprising a controller (20, Fig. 1), a medical device (12, Fig. 1) for delivering medication, and a user interface (82, Fig. 3); wherein the controller determines status of completion of the delivery of medication based on a timer initiated at the initiation of the delivery of the medication (See Fig. 22, step 404; as disclosed in Para 0138, a status indicator 304 is updated as a function of time to show the progress of the delivery of medication; a timer is started when the delivery is initiated as shown in Fig. I8A when status indicator 304 begins at the “now” position: as shown in Fig. 18B, the status indicator 304 shows the status of completion of delivery of medication based on time elapsed, as disclosed in Fig. 22 and Par. 0138), the controller using the amount of time elapsed by the timer as the selected event for transitioning the status indicator (Para 0138, status indicator 304 transitions along the timeline as a function of time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to determine the status of completion of the delivery based on a timer as taught by Alme in order provide the user with a timeline of the therapy (Para 0122).
Regarding claim 29, the modified invention of Walsh, Aalto-Setala, My Water, and Alme discloses the controller changes the level indicator relative to the background image in the delivery status screen to display a selected amount of the background gradient image relative to the background image (Para 0025-0026 -Walsh) that corresponds to the amount of time elapsed indicated by the timer (Para 0138 -Alme).
Regarding claim 34, the modified invention of Walsh, Aalto-Setala, and My Water discloses the controller changes the level indicator relative to a background image in the delivery status screen to display a selected amount of the background gradient image relative to the background image that corresponds to the progress of the delivery (Para 0025-0026 -Walsh), however, is silent regarding the controller determines status of completion of the delivery of the medication based on a timer initiated at the initiation of the delivery of the medication, the controller using the amount of time elapsed indicated by the timer as the selected event for transitioning each of the rotating progress ring symbol and the level indicator.
Alme teaches an analogous invention directed to a system (Fig. 1) comprising a controller (Fig. 1, element 20), a medical device (Fig. 1, element 12) for delivering medication, and a user interface (Fig. 3, element 82); wherein the controller determines status of completion of the delivery of medication based on a timer initiated at the initiation of the delivery of the medication (Fig. 22, step 404; as disclosed in Para 0138, a status indicator 304 is updated as a function of time to show the progress of the delivery of medication; a timer is started when the delivery is initiated as shown in Fig. I8A when status indicator 304 begins at the “now’ position: as shown in Fig. 18B, the status indicator 304 shows the status of completion of delivery of medication based on time elapsed, as disclosed in Fig. 22 and Par. 0138), the controller using the amount of time elapsed by the timer as the selected event for transitioning the status indicator (Para 0138, status indicator 304 transitions along the timeline as a function of time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to determine the status of completion of the delivery based on a timer as taught by Alme in order provide the user with a timeline of the therapy (Para 0122).
Claims 27-28, 30 are rejected under 35 U.S.C. 103 as being unpatentable over Walsh (US 2014/0276531) in view of Aalto-Setala (US 2009/0209938) and further in view of My Water (“My Water: Daily Drink Tracker”) and further in view of Alme (US 2010/0185182) and further in view of Lebel (US 6740075).
Regarding claim 27, the modified invention of Walsh, Aalto-Setala, My Water, and Alme discloses all of the elements of the invention as discussed above, however, is silent regarding the controller rotates the progress ring symbol a selected number of degrees corresponding to the amount of time elapsed indicated by the timer.
Lebel teaches an analogous Invention directed to a controller (32, Fig 3) connected toa medical device (2, Fig 3), configured to control delivery of medication, the controller configured to generate a display screen (display shown in Fig 5) which includes a delivery status of a medication, the delivery status comprising a rotating progress ring symbol (864, Fig 5), wherein the controller rotates the progress ring symbol a selected number of degrees corresponding to the amount of time elapsed indicated by the timer (Col. 59, Hines 50-63; the rotating progress ring symbol rotates one quarter, or 90 degrees, for every 4 seconds elapsed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller to rotate the rotating progress ring symbol a selected number of degrees corresponding to the amount of time elapsed indicated by the timer, as taught by Lebel, in order to indicate that a delivery is in progress and enhance user interface capabilities (Col 2, lines 38-41).
Regarding claim 28, the modified invention of Walsh, Aalto-Setala, My Water, Alme, and Lebel discloses the progress ring symbol (15, Fig 2 -Aalto-Setala) comprises at least one of a notch (See annotated Fig 2 below) along its circumference or a gradient in the thickness of the progress ring symbol to facilitate user discernment of rotation of the progress symbol.
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Regarding claim 30, the modified invention of Walsh, Aalto-Setala, My Water, and Alme discloses all of the elements of the invention as discussed above, however, is silent regarding the controller rotates the progress ring symbol at a rate that transitions the progress ring symbol faster than the changes in the level indicator.
Lebel teaches an analogous Invention directed to a controller (32, Fig 3) connected to a medical device (2, Fig 3), configured to control delivery of medication, the controller configured to generate a display screen (display shown in Fig 5) which includes a delivery status of a medication, the delivery status comprising a rotating progress ring symbol (864, Fig 5), wherein the controller rotates the progress ring symbol a selected number of degrees corresponding to the amount of time elapsed indicated by the timer (Col. 59, Hines 50-63; the rotating progress ring symbol rotates one quarter, or 90 degrees, for every 4 seconds elapsed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller to rotate the rotating progress ring symbol a selected number of degrees corresponding to the amount of time elapsed indicated by the timer, as taught by Lebel, in order to indicate that a delivery is in progress and enhance user interface capabilities (Col 2, lines 38-41).
Examiner notes that the rotating progress ring symbol of the modified invention would rotate at 90 degrees every 4 seconds, i.e., a complete turn every 16 seconds. Walsh teaches that the level indicator moves at a rate corresponding to the remaining time of the delivery. In at least the instances when the delivery takes longer than 16 seconds, the rotating progress ring symbol will complete one full rotation more than once while the level indicator will only traverse the bar once. Thus, the rotating progress ring symbol will change faster than the level indicator
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Walsh (US 2014/0276531) in view of Aalto-Setala (US 2009/0209938) and further in view of My Water (“My Water: Daily Drink Tracker”) and further in view of Kamen (US 2015/0011970).
Regarding claim 31, the modified invention of Walsh, Aalto-Setala, and My Water discloses all of the elements of the invention as discussed above, however, is silent regarding the controller is separate from the medical device and connected thereto via wireless communications.
Kamen teaches a device for controlling delivery of a medication to a patient’s body, comprising a controller (1800, Fig 18) connected to a medical device (1802, Fig 18) and configured to control delivery of the medication from the medical device to the patient’s body; wherein the controller is separate from the medical device and connected thereto via wireless communications (Para 0426).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have a separate controller and medical device that are wirelessly connected as taught by Kamen in order to reduce the size and weight of the medical device to be more easily wearable (Para 0007).
Claim 37-39 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Walsh (US 2014/0276531) and further in view of Aalto-Setala (US 2009/0209938) and further in view of My Water (“My Water: Daily Drink Tracker”).
Regarding claim 37, the modified invention Rosinko, Walsh, and Aalto-Setala discloses wherein the level indicator (94, Fig 4 -Walsh) comprises a transition line delineating a background image of the screen and a background gradient image, and the controller is configured to control movement of the transition line in the delivery status screen to vary the size of the background gradient image displayed relative to the background image (Para 0025-0026 -Walsh), however, is silent regarding wherein the GUI display is characterized by a defined area and each of the display screens also has the defined area of the display; respective portions of the background image and the background gradient image combined constitute an entirety of a display screen generated on the display.
My Water discloses a graphical user interface (GUI) displaying a level indicator comprising a transition line delineating a background image (light color area) of the screen and a background gradient image (darker fill color) whereby respective portions of the background image and the background gradient image combined constitute an entirety of the delivery status screen generated (See pages 1 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the level indicator disclosed by Walsh to be a full screen level indicator as taught by My Water as Walsh teaches that the level indicator can be portrayed to the user in various configurations (Para 0025). Further, in Para 0070 of the instant specification, it is indicated that other types of level indicators can be used and therefore, there is no specific criticality to the claimed level indicator design. It has been held that a mere matter of design choice is unpatentable as a person of ordinary skill in the art would have found it obvious absent persuasive evidence that the particular claimed configuration was significant (See MPEP 2144.04(IV)(B); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Regarding claim 38, the modified invention of Rosinko, Walsh, Aalto-Setala, and My Water discloses the background image of the delivery status screen and the background gradient image are generated using two different colors (Para 0025-0026 -Walsh).
Regarding Claim 39, the modified invention of Rosinko, Walsh, Aalto-Setala, and My Water discloses the progress ring is displayed in the same area of the display wherein the level indicator is moved to alter the amount the background gradient image that is displayed relative to the background image (Para 0025-0026 -Walsh; Para 0117 -Aalto-Setala; As this is a very vague limitation, having the progress ring and level indicator on the same screen can be interpreted as on the same area. The claim does not specify how close they need to be to one another.)
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2018/0021514) in view of Walsh (US 2014/0276531) and further in view of Aalto-Setala (US 2009/0209938) and further in view of My Water (“My Water: Daily Drink Tracker”) and further in view of Alme (US 2010/0185182).
Regarding claim 40, the modified invention of Rosinko, Walsh, Aalto-Setala, and My Water discloses all of the elements of the invention as discussed above, however, is silent regarding the controller changes the transition line relative to the background image in the delivery status screen to display a selected amount of the background gradient image relative to the background image that corresponds to a selected event chosen from a status of completion of delivery of the medication based on a timer started at the initiation of the delivery of the medication, and a selected change in the units of the medication delivered to the patient's body.
Alme teaches an analogous invention directed to a system (Fig. 1) comprising a controller (20, Fig. 1), a medical device (12, Fig. 1) for delivering medication, and a user interface (82, Fig. 3); wherein the controller determines status of completion of the delivery of medication based on a timer initiated at the initiation of the delivery of the medication (See Fig. 22, step 404; as disclosed in Para 0138, a status indicator 304 is updated as a function of time to show the progress of the delivery of medication; a timer is started when the delivery is initiated as shown in Fig. I8A when status indicator 304 begins at the “now” position: as shown in Fig. 18B, the status indicator 304 shows the status of completion of delivery of medication based on time elapsed, as disclosed in Fig. 22 and Par. 0138), the controller using the amount of time elapsed by the timer as the selected event for transitioning the status indicator (Para 0138, status indicator 304 transitions along the timeline as a function of time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to determine the status of completion of the delivery based on a timer as taught by Alme in order provide the user with a timeline of the therapy (Para 0122).
Response to Arguments
Applicant’s arguments filed 10/16/2025, on pages 17-22, regarding the combination of Walsh and Allen have been fully considered but are moot in view of the current rejection that no longer relies on this combination to teach the first and second screens.
Applicant’s arguments filed 10/16/2025, on pages 23-25, regarding one of ordinary skill would not want the bolus object 82 of Walsh and the rotating progress wheel 15 of Aalto-Setala as Walsh’s animated line already provides such feedback have been fully considered but is not persuasive. As stated in Para 0117 of Aalto-Setala, the ring 15 is relied upon to show that the pump is working evenly and continuously. This information cannot be easily gleaned from the level indicator, especially if the increments that the level indicator moves are too large to notice intermittent interruptions or uneven dosing. Applicant further argues that Aalto-Setala’s symbol 15 is not a ring but a solid shape. Examiner points to Fig 2 of Aalto-Setala that shows that the symbol 15 is, in fact, not a solid shape and has an opening in the center. Therefore, it can be construed as a ring. Applicant also points out that adding the rotating progress wheel to display with the bolus object 82 of Walsh would make it appear crowded and obscure the status indicator 92 have been fully considered but are not persuasive. This appears to be an argument of bodily incorporation. It is known that "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." (In re Keller, 642 F.2d 413, 425, 208 USPQ 871 , 881 (CCPA 1981)). One of ordinary skill would be able to adjust the GUI so that none of the elements are obscured and are visible. Additionally, what is “crowded” is a matter of opinion and not a matter of fact. Thus, this argument has no bearings on what one of ordinary skill would include on a display to provide added functionality.
Applicant’s arguments filed 10/16/2025, on pages 25-27, regarding My Water failing to teach automatically and incrementally moving the transition line based on the selected event have been fully considered but are not persuasive. As detailed in the rejections above, My Water is merely used to change the visual design of the level indicator as taught by My Water. Walsh’s level indicator already has the claimed functionality as described in Para 0026. Therefore, the combined invention of Walsh and My Water, teaches the amended limitation. Applicant also argues that a person would not be motivated to modify the bolus object 82 that occupies a portion of the screen to occupy an entirety of the screen. Applicant does not provide any reasoning why one of ordinary skill wouldn’t do this. This appears to be simply a matter of design choice in how to display an element on a GUI. As stated in the rejection of claim 20 above, the instant specification specifies (Para 0070) that other types of level indicators can be used and therefore, there is no specific criticality to the claimed level indicator design. It has been held that a mere matter of design choice is unpatentable as a person of ordinary skill in the art would have found it obvious absent persuasive evidence that the particular claimed configuration was significant (See MPEP 2144.04(IV)(B); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Applicant’s arguments filed 10/16/2025, on pages 28-29, regarding Walsh, Allen, and Aalto-Setala failing to disclose the limitations of dependent claims 5, 6, 9, 14, 16, 17 have been fully considered but are moot in view of the current rejection that relies on new ground of rejection in view of Rosinko, Allen, and Bandyopadhyay to teach the fourth and fifth screens.
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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/ANTARIUS S DANIEL/
Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783