DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 2, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below to teach sensors determining each specifically claimed step being completed.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 52, 55, 60 and 64 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Battiato et al. (US 5,868,710) in view of Barrett et al. (US 2009/0221914) in view of Rosenblatt et al. (US 2010/0082821), and further in view of Kullas et al. (US 6,077,246).
Regarding claim 52, Battiato et al. (henceforth Battiato) discloses a method of injecting one or more fluids into a patient comprising: providing a fluid injection system (Figure 1) comprising: an injector head (22) for delivering at least one fluid to the patient; a plurality of sensors positioned within the injector head for generating signals indicative of the status of the injector head (flag sensor 58, Col. 8, lines 45-47; light sensor 127, Col. 13, lines 32-40; tilt sensor 158, Col. 15, lines 26-31; plunger rotary encoders, Col. 16, line 66-Col. 17, line 7); a control system (CPU and associated microcontroller 192; Col. 16, line 36-Col. 18, line 55 disclose the controller and its design and uses) operationally coupled to the injector head and the plurality of sensors for controlling an injection procedure, said control system having a display unit (both 30 and 32 are used to display data or control the unit; Col. 18, lines 3-17); and the display unit comprising a graphical user interface (32, see Figures 13B and 13C; Col. 20, lines 21-30) having a first area with at least one on-screen control for sending a signal to the control system to arm the injector head and a second area for displaying a list of actions that must be completed by a user before the injector head can be armed to perform the injection procedure (see e.g., Col. 20, lines 21-30 which disclose that the unit will prevent an injection until the tilt sensor is within the specific angle, or a user overrides the position requirement; the display is capable of generating any desired information), generating a list of actions (e.g., preventing injection until the head is within region 4 in Figure 13A; Col. 19, line 57-Col. 20, line 44), based on the signals generated by the plurality of sensors (via the tilt sensor); determining via one of the plurality of sensors determines that the user has completed the action (Col. 19, line 57-Col. 20, line 16 disclose preventing an injection when the injector head is tilted up into regions 1, 2a, or 2b, but allowing an injection when it is tilted down into region 4), and manually arming the injector head to inject the at least one fluid into the patient (e.g., Col. 19, line 57-Col. 20, line 16 disclose a user moving the injector head into region 4 to allow for an injection to take place either manually via movement of the drive ram lever 29, or automatically). Battiato fails to explicitly disclose generating a list which represents a plurality of physical states of the injector head, and the step or removing an action from the list of actions, the inoperable area of the GUI, and the steps of removing the boxes as the actions are completed.
Barret et al. (henceforth Barrett) teaches a method providing a fluid injection system comprising: an injector head (100) for delivering one or more fluids to a patient; a plurality of sensors (e.g., pressure sensor 114, temperature sensors 140 as per claim 64, syringe loading sensor 166; ¶¶ [0099], [0102], [0115], and [0160]) positioned within the injector head for generating signals indicative of the status of the injector head; a control system (within console 12) operationally coupled to the injector head and the plurality of sensors for controlling an injection procedure, said control system having a display unit (58), the display unit comprising a graphical user interface (e.g., screen and buttons) having a first area with at least one button (56) for sending a signal to the control system to arm the injector head and a second area (e.g., display area depicted in Figure 4) for displaying a list of actions that must be completed by a user before the injector head can be armed to perform the injection procedure (the display is fully capable of displaying any desired data or instructions), generating a list of actions (e.g., ¶ [0115] discloses user instructions placed on the display to insert the syringe, close, and lock the chamber which constitute a list to be performed as claimed), based on the signals generated by the plurality of sensors, wherein the list of action represents a plurality of physical states of the injector head (¶ [0115] sets forth a number of physical states of the injector head such as the disclosure of several states and steps that must be performed before an injection can take place such as inserting the syringe, closing the door, and attaching the reservoir; these are all related to physical states of the device and meet the limitation as currently set forth); displaying the list of actions on the display unit in the second area of the graphical user interface (e.g., any area separate from the button portion as above); and causing the at least one button provided in the first are of the graphical user interface to be inoperable until each of the actions in the list of actions has been completed by the user, (as set forth in ¶ [0115], the OK button 218 is not to be pressed until the list of items in the checklist has been completed; it is understood that pressing the button before the checklist has been completed will have no result; this feature is further described in ¶ [0121] wherein the button 218 cannot be activated before another button 208 is activated after performing a function; see also Figure 4, button 208 labeled “Enable OK”). Barrett further discloses an interface comprising buttons which disclose current steps to be performed and associated sensors for sensing such processing steps; see also ¶ [0133] which discloses the display changing the status output depending on the stage of an injection procedure); wherein the list of actions is provided in a box displayed on the display unit (Figure 4, boxes, 250, 252, 254): and the method further comprises: removing the box from the display unit when every action on the list of actions has been completed (the text from the box is removed which is considered to meet the claim limitation; e.g., ¶¶ [0131] and [0132]); and manually arming (e.g., interacting with) the injector head to inject the at least one fluid into the patient (a number of switches on the control panel are manually interacted with, or armed by the user before an injection is performed; see ¶¶ [0114]-[0130]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Battiato to comprise providing a list of actions to be performed, based on sensor readings, to ensure proper function of the system prior to an injection as taught by Barrett. Barrett teaches that it is known to provide a list of injector head states, and to provide a GUI with interactions that are required before a user can initiate an injection. As above, Battiato contemplates preventing injection until a tilt sensor registers that the device head is at a preferred angle for injection. Therefore, one of ordinary skill would have been motivated to modify the device of Battiato to utilize similar checks in the system for any desired parameters, based on similar sensor readings of each element, before an injection is performed to ensure the device is safe for use.
Battiato and Barrett still fail to disclose removing an action from the list of actions on the display unit after a sensor determines that the user has completed the action and removing the box from the second area of the graphical user interface of the display unit, allowing the at least one on-screen control provided in the first area of the graphical user interface to become operable.
Rosenblatt et al. (henceforth Rosenblatt) teaches a device workflow method whereby an interface (28; analogous to the GUI of Barrett) provides an action box (e.g., 158) which is removed from the workspace following some action (¶ [0088]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Battiato/Barret to allow actions which have been completed to be removed from a user interface as Rosenblatt teaches that such a removal of performed action icons within an interface is known. As above, Battiato/Barrett/Rosenblatt fail to teach removing the box from the second area of the graphical user interface of the display unit, allowing the at least one on-screen control provided in the first area of the graphical user interface to become operable.
Kullas et al. (henceforth Kullas) teaches a method of operating a device comprising removing a box from the second area of the graphical user interface of the display unit (via pressing the confirmation button, allowing the at least one on-screen control provided in the first area of the graphical user interface to become operable (Col. 3, lines 23-26 disclose a confirmation box which must be interacted with before any other menu options can be utilized; interacting with the displayed procedure type display by pressing a confirmation button will then allow for other menu items to be accessed such as the motor speed control).
Therefore, it would have been obvious to modify the method to of Battiato/Barret to comprise the confirmation box safety feature of Kullas so as to provide a means of ensuring the proper injection profile and parameters are being utilized during a procedure as taught by Kullas (via patient confirmation of a button in response to a displayed instruction).
The above combination provides motivation for the following list of actions which are set forth in claim 52:
Receiving a first signal from a sensor configured to provide a signal to the control system to determine if a syringe has been loaded into the injector head; based on the first signal ( Barrett teaches a syringe load sensor an application in ¶ [0115]; sensor 166 alerts the computer that a syringe has been loaded), determining whether the syringe has been loaded into the injector head (¶ [0155]); removing the load syringe action from the list of actions if a determination is made that the syringe has been loaded into the injector head (as above Rosenblatt and Kullas teach box removal from a GUI);
Receiving a second signal from a sensor configured to provide a signal to the control system to determine if a syringe retaining wall of the injector head has been properly positioned (Battiato teaches that flag sensor 58 signals to the device that the faceplate for retaining the syringe has been properly positioned and an injection can be performed, and the faceplate retaining member is analogous to a syringe wall retainer or “drop front”; Col. 8, lines 24-47); based on the second signal, determining whether the syringe retaining wall of the injector head has been properly positioned (based on the flag sensor as above); removing the engage drop front action from the list of actions if a determination is made that the syringe retaining wall of the injector head has been properly positioned (as above, Battiato contemplates using the flag sensor to ensure the injector is properly installed and the door closed before a filling or injector procedure; the step, once determined to be true, would then initiate removal of the item from the GUI list as taught in the cited combination by Rosenblatt and Kullas);
Receiving a third signal from a sensor (rotary encoders 182 of Battiato) configured to provide a signal to the control system to determine if a plunger of the syringe has been advanced; based on the third signal, determining whether the plunger of the syringe has been advanced (e.g., Col. 17, lines 52-64 disclose reading the encoder signals to determine if the CPU is requesting movement of the plunger, or checking for absence of pulses from the encoders; see also Col. 18, lines 3-17 which disclose automatic control of the plunger via interacting with the GUI on screen 32); removing the advance plunger action from the list of actions if a determination is made that the plunger of the syringe has been advanced (the action would be removed as taught above by Rosenblatt and Kullas);
Receiving a fourth signal from a sensor configured to provide a signal to the control system of a position of the injector head; based on the fourth signal, determining the position of the injector head (Battiato, as above, teaches the use of a tilt sensor 158 for determining the position of the injector head relative to gravity; see Figures 13A-13C; Col. 19, line 49-Col. 20, line 44 disclose the various tilt angles and how they’re used to purge the syringe of air via positioning in region 1 before moving the plunger and subsequently tilting the device to region 4 to allow for an injection); and removing the rotate injector head down to arm action from the list of actions if a determination is made that the position of the injector head is appropriate (as above, the item would be removed from the list as taught by Rosenblatt and Kullas).
Therefore, one of ordinary skill in the art, when provided with the cited references, would have sufficient motivation to utilize the known sensors of Battiato and Barrett, along with the listing methods and GUI navigation features taught by Rosenblatt and Kullas, so as to arrive at the claimed invention. Creating a checklist based upon disclosed sensor data, and navigating through such a list via sensor outputs which are used to determine injector head states, would have been obvious to one of ordinary skill in the art at the time of the invention based on the cited references.
Regarding claim 55, Battiato/Barrett fail to explicitly disclose the list of actions comprising the claimed selection. However, as above, Battiato discloses that a purge procedure, which includes tilting the injector head up to a specific range of angles and advancing the plunger (Col. 6, lines 28-39 disclose the tilting is performed before an injection and Col. 19, line 57-Col. 20, line 35 disclose the various tilt angles required and which allow or prevent an injection), is performed before a procedure. Also, Barrett further teaches that a purge procedure is performed via operations displayed to a user before a procedure and which include a user interacting with a “done” switch at the end of the purge (see ¶ [0180] of Barrett). From these disclosures, it would have been obvious to one of ordinary skill in the art to modify the system of Battiato/Barrett/Rosenblatt/Kullas to include the checklist step of rotating the injector head up and purging as an addition to the list of tasks to be completed. In this manner, the removal of air from the system is ensured (which is critical to both Battiato and Barrett) via the system requiring the user to perform the step before an injection can take place. The sensors and user interaction for such a step is known from Battiato and Barrett and would therefore be obvious to add to the list of actions to be performed and to be removed from the GUI after the tilt sensor and plunger sensors have determined that a tilt and purge has occurred.
Regarding claim 60, Barrett further teaches wherein the control system alerts the user when every action on the list of actions has been completed (e.g., ¶ [0115] sets forth that the user will be instructed to press OK button 218 after all steps have been taken which corresponds to a user alert as claimed). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the GUI of Battiato to comprise the alert system of Barrett to ensure a user must initialize the device before an injection procedure to aid in preventing accidental use as taught by Barrett.
Regarding claim 64, Battiato further discloses a plurality of temperature sensors positioned within the vicinity of the actuation system within the housing of the injector head for generating signals indicative of a temperature of the actuation system, and wherein at least one temperature sensor of the plurality of temperature sensors measures the housing ambient temperature (Col. 15, line 41-Col. 16, line 10 disclose a plurality of thermistors 163a and 163b which are located in the injector head, attached to circuit board, for measuring an ambient temperature of the system so as to calculate the needed energy output of the blanket 42 so as to maintain the fluid at body temperature for the procedure; the cited columns teach the measurement of the ambient temperature inside the housing since that is the location of the thermistors).
Claims 61-63 is/are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Battiato in view of Barrett in view of Rosenblatt in view of Kullas, and further in view of Spohn et al. (US 2008/0086087).
Regarding claims 61-63, Battiato/Barrett/Rosenblatt/Kullas teach the claimed invention substantially as set forth above for claim 52, and further discloses attaching the injector head to a mobile base (e.g., cart 402, Figure 9A) and the use of pivoting support arms for the display (e.g., Figure 45). They fail to explicitly disclose placing the injector head on the cart via the pivoting support arms as claimed.
Spohn et al. (henceforth Spohn) teaches (Figures 32 and 33) a fluid injection system and corresponding mounting structure pivotally connected to an injector head (1300) and configured to support the injector head (¶ [0281]), wherein the mounting structure comprises: a mobile base (1614) positioned on a floor; a pole (formed from 1606, 1604, and 1608) extending from the mobile base above the floor; and a first support arm having a first end pivotally coupled to the pole (at the distal end with arm 1604 and the connection to pedestal interface 1612) and a second end pivotally connected to the injector head (e.g., connection joint between 1606 and 1300 as depicted in Figures 9 and 33; paragraph [0229] discloses the pivoting of the injector head relative to the control module in the support structure); wherein the mounting structure further comprises a second support arm having a first end pivotally coupled to the pole and a second end pivotally connected to a display unit (210, Figures 9 and 33; second support arm 1602 is pivotally connected to the pole at element 1608 and to the display unit at the connection point for the display support pole which would be a rotatable or pivoting connection to allow the screen to be adjusted as needed).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the pivoting support assembly of Battiato/Barrett to hold both the injector head and display unit as taught by Spohn to allow the system to be moved around a hospital and transferred between the movable pedestal and patient bed if desired as taught by Spohn (e.g., ¶ [0281]).
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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