DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 5 and 20 are cancelled. Claims 1, 16, and 44 are currently amended. Claims 1, 3, 6-7, 9-11, 13-16, 18, 21-22, 24, and 44-48 are currently pending. Claims 1, 3, 6-7, 9-11, 13-16, 18, 21-22, 24, and 44-48 are currently rejected.
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not entirely persuasive.
The previous drawing objection, claim objections, and 112(b) rejection are all withdrawn in view of Applicant’s amendments to the drawings and claims.
Applicant argues that the new limitation, “wherein rotation of the user input device in one direction results in a same movement of the actuator regardless of the orientation of the housing” overcomes the previous rejections of independent claims 1, 16, and 44. A modified rejection is presented below, necessitated by this newly added limitation. However, this limitation also introduces a 112(b) issue, as outlined below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 6-7, 9-11, 13-16, 18, 21-22, 24, and 44-48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 16 include the limitations:
“determine a direction of fluid actuation based on the orientation of the housing and the at least one signal” and
“wherein rotation of the user input device in one direction results in a same movement of the actuator regardless of the orientation of the housing”.
Claim 44 similarly includes the limitations:
a. “determine a direction of fluid actuation based on the orientation of the housing based on input from the tilt sensor and the at least one signal” and
b. “wherein rotation of the user input device in one direction results in a same movement of the actuator regardless of the orientation of the housing”.
These limitations appear to claim, respectively, that (a) the orientation of the housing influences the direction of fluid actuation, and (b) the orientation of the housing has no bearing on the direction of fluid actuation. Together, these limitations render the claim confusing to the reader, and it becomes unclear whether or not the orientation of the housing influences the direction of fluid actuation. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 3, 6-7, 9-11, 13-15, 18, 21-22, 24, and 45-48 are rejected at least for depending on an indefinite claim noted above, since dependent claims inherit the deficiencies of those claims from which they depend.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 10, 14-16, 18, 44-45, and 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iddon et al (US 20180169327 A1; hereafter Iddon) in view of Savage (US 20040158205 A1; hereafter Savage) and (DE 102017011684 A1; hereafter Landwehr). Text citations are made to the pdf English translation of Landwehr included with the previous Office Action.
Regarding claim 1, Iddon discloses a fluid injector system configured to perform an injection protocol, the fluid injector system (system 1000 for controlling a fluid delivery, fig. 7, [0086]) comprising:
a housing (housing 125, fig. 7, [0082]); and
a controller (portable computer 150, fig. 7, [0082]) operatively associated with a user input device (touch screen noted in [0083] as associated with the portable computer 150), a tilt sensor ([0082] orientation sensor 185 associated with controller 150, orientation sensor may be a gyroscopic sensor; Note instant application PGPUB [0124] “The tilt sensor 802 may include, for example, a gyroscope, an accelerometer, or the like”), and a fluid actuator (piston associated with syringe 120, noted in [0064]), the controller (150) comprising at least one processor ([0069] portable computer 150 may include one or more processors) programmed or configured to:
determine an orientation of the housing based on input from the tilt sensor ([0082] orientation of housing is determined by orientation sensor 185 associated with controller 150);
receive at least one signal from the user input device ([0070] user selected parameters 170, fig. 4, [0070] user may manipulate the flow rate and other parameters using the touch screen of the portable computer 150);
determine a direction of fluid actuation based on the at least one signal ([0083] The portable computer 150 may be configured or programmed to adjust the orientation of its display including the various touch pad features; [0070] user may manipulate flow rate); and
actuate the fluid actuator in the direction of fluid actuation ([0064] injector 100 may inject fluid into the body, [0081] syringes may be filled or used to inject fluid),
wherein the fluid actuator is at least one of a piston actuator (piston associated with syringe 120, noted in [0064]), a pump actuator, and a compressive actuator ([0064] injector 100 may inject fluid into the body by driving a plunger of the at least one syringe 120 with at least one piston operated by a fluid control device 136 in FIG. 7; [0066] controller 150 may control the fluid control module which may operate pistons/valves to regulate medical fluid delivery); and
wherein the direction of fluid actuation corresponds to at least one of actuating the fluid actuator to inject fluid from a fluid reservoir (syringe 120, fig. 7) ([0081] an inverted position, which may facilitate, for example, the removal of air bubbles in a medical fluid contained within a syringe 120, or the conducting of an injection procedure) and actuating the fluid actuator to draw fluid into the fluid reservoir ([0081] a substantially vertical position, with the syringe port(s) 126 pointing upwards, may facilitate the filling of a syringe 120 with medical fluid, see fig. 7).
Iddon is silent to determining a direction of fluid actuation based on the orientation of the housing in addition to the at least one signal. Examiner notes that Iddon [0081] explains that having the injector in a vertical position may facilitate filling of a syringe, while the inverted position may facilitate conducting an injection procedure.
Savage, in the art of medical injector systems sensitive to orientation of the housing, teaches wherein a controller (control and drive elements noted in [0375]) determine a direction of fluid actuation based on the orientation of the housing ([0314] injector tilt switches or sensors may inhibit injection until the injector and syringe are oriented downward, or enable higher flow rates during filling than during injection; [0376] switches 4010 and 4020 change state based on orientation of the head 4000, see fig. 41 and 42 and may initiate or inhibit function of the injector; [0377] sensors may be used in place of the switches 4010/4020).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon to inhibit certain injector functions in certain housing orientations as taught by Savage in addition to requiring the user direction as disclosed in Iddon since Savage also deals with a rotatable housing used for fluid injection to a patient. One would have been motivated to make the modification to require the orientation to be upward/vertical for filling and downward/inverted for injection because, as noted by Iddon [0081], having the injector in a vertical position may facilitate filling of a syringe, while the inverted position may facilitate conducting an injection procedure. As further noted in Savage [0273], having the syringe in a down orientation during injection avoids injecting residual amounts of air that may reside in the syringe into the patient. Thus, having the controller of Iddon determine the direction of fluid actuation based not only on user input but also on the orientation of the housing helps to avoid performing processes when not in the best position for that process.
Iddon modified by Savage and Landwehr is silent to the signal comprising a rotation direction of the user input device.
Landwehr, in the art of medical devices and relating to a user selecting a parameter, teaches wherein the at least one signal (sensor signals 24, fig. 2, [0035]) from the user input device (rotary knob 12, fig. 2, [0035]) comprises a rotation direction of the user input device ([0035] control device 22 included in the medical device 10 receives sensor signals 24 from the rotation angle sensor 16 and continuously determines a respective direction of rotation of the rotary knob 12 and a change in the angle of rotation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Iddon with the teachings of Landwehr to have the fluid actuation speed of Iddon set proportional to a speed at which a knob is turned, as taught by Landwehr, since both references deal with user interfaces for medical devices. Replacing the touchscreen user input device of Iddon, or replacing a touchscreen button of Iddon, with a knob as taught by Landwehr, would be a simple substitution of one user input device (a button on a touchscreen) for another user input device known in the art (the knob taught by Landwehr) and would have had predictable results to one of ordinary skill in the art. The device of Iddon as previously modified would still work with a knob instead of a touchscreen button.
Iddon as modified by Savage and Landwehr, as described above, discloses wherein rotation of the user input device (Savage: rotary knob 12, fig. 2) in one direction results in a same movement of the actuator (Iddon: piston associated with syringe 120, noted in [0064]) regardless of the orientation of the housing (see 112b interpretation above) (Examiner notes that the piston must move longitudinally along the syringe whether filling or delivering fluid, therefore preforming a “same movement” along the same axis, no matter the orientation of the housing.).
Regarding claim 3, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1, as described above, including wherein the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors) is further programmed or configured to:
determine a change in the orientation of the housing ([0376] the switches 4010 and 4020 change state when the orientation of the housing changes);
wherein the orientation of the housing comprises a degree of tilt relative to a neutral plane (see Savage fig. 41-42, [0375]-[0376], the head tilts relative to the pedestal 4100, arm of pedestal 4100 provides a neutral plane).
Iddon as modified above is silent to the processor further configured to changing the direction of fluid actuation in response to determining the change in the orientation of the housing.
Savage, in another embodiment, further teaches wherein the at least one processor (injector control panel and position/angle sensing tilt switch, noted in [0298], see fig. 24) is further programmed or configured to:
determine a change in the orientation of the housing ([0298] operator tilts the injector 1016 and syringe 1014 upward and the tilt switch senses the change in the position/angle); and
change the direction of fluid actuation in response to determining the change in the orientation of the housing ([0298] a position or angle sensing tilt switch in the injector preferably causes the piston 1032 of the syringe 1014 to advance automatically).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Iddon with the teaches of a similar embodiment of Savage, since this embodiment also deals with fluid injection and the orientation of the fluid injector. One would have been motivated to make the modification because having the syringe automatically perform the correct action when in the correct position would cut down on the possibility for user error resulting in performing filling/delivery syringe actuation when in the incorrect housing orientation. This modification would also reduce the burden on the operator since it would require less operator input over the course of the device’s use.
Regarding claim 10, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1, as disclosed above, including wherein the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors) is further programmed or configured to:
determine a current status of the fluid injector system (see explanation of combination of Savage [0376] and Iddon [0081], note that Iddon [0081] associates the vertical/upward position with the filling status and the inverted/downward position with the injection status);
disable at least one direction of fluid actuator movement based on the orientation (see explanation of combination of Savage [0376] and Iddon [0081], note that Savage [0376] describes inhibiting injector functions according to the orientation of the head 4000).
Regarding claim 14, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1. Iddon further discloses comprising at least one valve (valve noted in [0066]),
wherein the at least one processor ([0069] portable computer 150 may include one or more processors) is further programmed or configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) actuate the valve in response to determining the direction of fluid actuation ([0066] controller 150 may control the fluid control module which may operate pistons/valves to regulate medical fluid delivery).
Regarding claim 15, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1, as disclosed above. Iddon further discloses wherein the user input device (touch screen noted in [0083] as associated with the portable computer 150, see fig. 7 for portable computer 150) is at least one of mounted to the housing and mounted remotely from the housing ([0082] portable computer 150 may be engaged/mounted on or disengaged/mounted remotely from the docking station 142, see fig. 7 note that the docking station is on housing 125 as described in [0082]).
Regarding claim 16, Iddon discloses a computer program product for actuating a fluid actuator of a fluid injector system (system 1000 for controlling a fluid delivery, fig. 7, [0086]) configured to perform an injection protocol, the computer program product comprising at least one non-transitory computer-readable medium ([0069] portable computer 150 includes one or more processors and a memory which stores parameters that can be accessed to be recalled and/or altered by the portable computer 150) comprising one or more instructions that, when executed by at least one processor ([0069] portable computer 150 may include one or more processors), cause the at least one processor to:
determine an orientation of a housing (housing 125, fig. 7, [0082]) of the fluid injector system ([0082] orientation of housing is determined by orientation sensor 185 associated with controller 150) based on input from a tilt sensor ([0082] orientation sensor 185 associated with controller 150, orientation sensor may be a gyroscopic sensor; Note instant application PGPUB [0124] “The tilt sensor 802 may include, for example, a gyroscope, an accelerometer, or the like”);
receive at least one signal from a user input device of the fluid injector system ([0070] user selected parameters 170, fig. 4, [0070] user may manipulate the flow rate and other parameters using the touch screen of the portable computer 150);
determine a direction of fluid actuation based on the at least one signal ([0083] The portable computer 150 may be configured or programmed to adjust the orientation of its display including the various touch pad features; [0070] user may manipulate flow rate); and
actuate the fluid actuator in the direction of fluid actuation ([0064] injector 100 may inject fluid into the body, [0081] syringes may be filled or used to inject fluid),
wherein the fluid actuator is at least one of a piston actuator (piston associated with syringe 120, noted in [0064]), a pump actuator, and a compressive actuator ([0064] injector 100 may inject fluid into the body by driving a plunger of the at least one syringe 120 with at least one piston operated by a fluid control device 136 in FIG. 7; [0066] controller 150 may control the fluid control module which may operate pistons/valves to regulate medical fluid delivery); and
wherein the direction of fluid actuation corresponds to at least one of actuating the fluid actuator to inject fluid from a fluid reservoir (syringe 120, fig. 7) ([0081] an inverted position, which may facilitate, for example, the removal of air bubbles in a medical fluid contained within a syringe 120, or the conducting of an injection procedure)and actuating the fluid actuator to draw fluid into the fluid reservoir ([0081] a substantially vertical position, with the syringe port(s) 126 pointing upwards, may facilitate the filling of a syringe 120 with medical fluid, see fig. 7).
Iddon is silent to determining a direction of fluid actuation based on the orientation of the housing in addition to the at least one signal. Examiner notes that Iddon [0081] explains that having the injector in a vertical position may facilitate filling of a syringe, while the inverted position may facilitate conducting an injection procedure.
Savage, in the art of medical injector systems sensitive to orientation of the housing, teaches wherein a controller (control and drive elements noted in [0375]) determine a direction of fluid actuation based on the orientation of the housing ([0314] injector tilt switches or sensors may inhibit injection until the injector and syringe are oriented downward, or enable higher flow rates during filling than during injection; [0376] switches 4010 and 4020 change state based on orientation of the head 4000, see fig. 41 and 42 and may initiate or inhibit function of the injector; [0377] sensors may be used in place of the switches 4010/4020).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon to inhibit certain injector functions in certain housing orientations as taught by Savage in addition to requiring the user direction as disclosed in Iddon since Savage also deals with a rotatable housing used for fluid injection to a patient. One would have been motivated to make the modification to require the orientation to be upward/vertical for filling and downward/inverted for injection because, as noted by Iddon [0081], having the injector in a vertical position may facilitate filling of a syringe, while the inverted position may facilitate conducting an injection procedure. As further noted in Savage [0273], having the syringe in a down orientation during injection avoids injecting residual amounts of air that may reside in the syringe into the patient. Thus, having the controller of Iddon determine the direction of fluid actuation based not only on user input but also on the orientation of the housing helps to avoid performing processes when not in the best position for that process.
Iddon modified by Savage is silent to the signal comprising a rotation direction of the user input device.
Landwehr, in the art of medical devices and relating to a user selecting a parameter, teaches wherein the at least one signal (sensor signals 24, fig. 2, [0035]) from the user input device (rotary knob 12, fig. 2, [0035]) comprises a rotation direction of the user input device ([0035] control device 22 included in the medical device 10 receives sensor signals 24 from the rotation angle sensor 16 and continuously determines a respective direction of rotation of the rotary knob 12 and a change in the angle of rotation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Iddon with the teachings of Landwehr to have the fluid actuation speed of Iddon set proportional to a speed at which a knob is turned, as taught by Landwehr, since both references deal with user interfaces for medical devices. Replacing the touchscreen user input device of Iddon, or replacing a touchscreen button of Iddon, with a knob as taught by Landwehr, would be a simple substitution of one user input device (a button on a touchscreen) for another user input device known in the art (the knob taught by Landwehr) and would have had predictable results to one of ordinary skill in the art. The device of Iddon as previously modified would still work with a knob instead of a touchscreen button.
Iddon as modified by Savage and Landwehr, as described above, discloses wherein rotation of the user input device (Savage: rotary knob 12, fig. 2) in one direction results in a same movement of the actuator (Iddon: piston associated with syringe 120, noted in [0064]) regardless of the orientation of the housing (see 112b interpretation above) (Examiner notes that the piston must move longitudinally along the syringe whether filling or delivering fluid, therefore preforming a “same movement” along the same axis, no matter the orientation of the housing.).
Regarding claim 18, Iddon modified by Savage and Landwehr discloses the computer program product of claim 16, as described above, including wherein the one or more instructions further cause the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors) to: determine a change in the orientation of the housing ([0376] the switches 4010 and 4020 change state when the orientation of the housing changes);
wherein the orientation of the housing comprises a degree of tilt relative to a neutral plane (see Savage fig. 41-42, [0375]-[0376], the head tilts relative to the pedestal 4100, arm of pedestal 4100 provides a neutral plane).
Iddon as modified above is silent to the processor further configured to changing the direction of fluid actuation in response to determining the change in the orientation of the housing.
Savage, in another embodiment, further teaches wherein the at least one processor (injector control panel and position/angle sensing tilt switch, noted in [0298], see fig. 24) is further programmed or configured to:
determine a change in the orientation of the housing ([0298] operator tilts the injector 1016 and syringe 1014 upward and the tilt switch senses the change in the position/angle); and
change the direction of fluid actuation in response to determining the change in the orientation of the housing ([0298] a position or angle sensing tilt switch in the injector preferably causes the piston 1032 of the syringe 1014 to advance automatically).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Iddon with the teaches of a similar embodiment of Savage, since this embodiment also deals with fluid injection and the orientation of the fluid injector. One would have been motivated to make the modification because having the syringe automatically perform the correct action when in the correct position would cut down on the possibility for user error resulting in performing filling/delivery syringe actuation when in the incorrect housing orientation. This modification would also reduce the burden on the operator since it would require less operator input over the course of the device’s use.
Regarding claim 44, Iddon discloses a fluid injector system configured to perform an injection protocol, the fluid injector system (system 1000 for controlling a fluid delivery, fig. 7, [0086]) comprising:
a housing (housing 125, fig. 7, [0082]); and
a fluid actuator (piston associated with syringe 120, noted in [0064]) operatively associated with a fluid reservoir (syringe 120, fig. 7, [0064]) and configured for controlling fluid flow into and out of the fluid reservoir ([0064] injector 100 may inject fluid into the body, [0081] syringes may be filled or used to inject fluid);
a user input device (touch screen noted in [0083] as associated with the portable computer 150) mounted remotely from the housing ([0071] portable computer 150, associated with the touchscreen/user input device, is detachable from the injector housing 125 and may be utilized to operate the fluid injection system remotely from other positions in the room) and configured for controlling of the fluid actuator ([0070] user selects parameters to control fluid delivery);
a tilt sensor ([0082] orientation sensor 185 associated with controller 150, orientation sensor may be a gyroscopic sensor; Note instant application PGPUB [0124] “The tilt sensor 802 may include, for example, a gyroscope, an accelerometer, or the like”); and
a controller (portable computer 150 noted in [0083] as associated with the touchscreen), operatively associated with the user input device (portable computer 150 noted in [0083] as associated with the touchscreen), the tilt sensor (orientation sensor 185, [0082] orientation sensor 185 associated with controller 150) and the fluid actuator ([0066] controller 150 may control the fluid control module which may operate pistons/valves to regulate medical fluid delivery),
the controller (150) comprising at least one processor ([0069] portable computer 150 may include one or more processors) programmed or configured to:
receive at least one signal from the user input device ([0070] user selected parameters 170, fig. 4, [0070] user may manipulate the flow rate and other parameters using the touch screen of the portable computer 150);
determine a direction of fluid actuation based on at least one of an orientation of the housing based on input from the tilt sensor and the at least one signal ([0083] The portable computer 150 may be configured or programmed to adjust the orientation of its display including the various touch pad features; [0070] user may manipulate flow rate); and
actuate the fluid actuator in the direction of fluid actuation ([0064] injector 100 may inject fluid into the body, [0081] syringes may be filled or used to inject fluid),
wherein the fluid actuator is at least one of a piston actuator (piston associated with syringe 120, noted in [0064]), a pump actuator, and a compressive actuator ([0064] injector 100 may inject fluid into the body by driving a plunger of the at least one syringe 120 with at least one piston operated by a fluid control device 136 in FIG. 7; [0066] controller 150 may control the fluid control module which may operate pistons/valves to regulate medical fluid delivery); and
wherein the direction of fluid actuation corresponds to at least one of actuating the fluid actuator to inject fluid from a fluid reservoir (syringe 120, fig. 7) ([0081] an inverted position, which may facilitate, for example, the removal of air bubbles in a medical fluid contained within a syringe 120, or the conducting of an injection procedure)and actuating the fluid actuator to draw fluid into the fluid reservoir ([0081] a substantially vertical position, with the syringe port(s) 126 pointing upwards, may facilitate the filling of a syringe 120 with medical fluid, see fig. 7).
Iddon is silent to determining a direction of fluid actuation based on an orientation of the housing in addition to the at least one signal. Examiner notes that Iddon [0081] explains that having the injector in a vertical position may facilitate filling of a syringe, while the inverted position may facilitate conducting an injection procedure, and Iddon [0082] notes that an orientation of housing is determined by orientation sensor 185 associated with controller 150.
Savage, in the art of medical injector systems sensitive to orientation of the housing, teaches wherein a controller (control and drive elements noted in [0375]) determine a direction of fluid actuation based on the orientation of the housing ([0314] injector tilt switches or sensors may inhibit injection until the injector and syringe are oriented downward, or enable higher flow rates during filling than during injection; [0376] switches 4010 and 4020 change state based on orientation of the head 4000, see fig. 41 and 42 and may initiate or inhibit function of the injector; [0377] sensors may be used in place of the switches 4010/4020).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon to inhibit certain injector functions in certain housing orientations as taught by Savage in addition to requiring the user direction as disclosed in Iddon since Savage also deals with a rotatable housing used for fluid injection to a patient. One would have been motivated to make the modification to require the orientation to be upward/vertical for filling and downward/inverted for injection because, as noted by Iddon [0081], having the injector in a vertical position may facilitate filling of a syringe, while the inverted position may facilitate conducting an injection procedure. As further noted in Savage [0273], having the syringe in a down orientation during injection avoids injecting residual amounts of air that may reside in the syringe into the patient. Thus, having the controller of Iddon determine the direction of fluid actuation based not only on user input but also on the orientation of the housing helps to avoid performing processes when not in the best position for that process.
Iddon modified by Savage is silent to the signal comprising a rotation direction of the user input device.
Landwehr, in the art of medical devices and relating to a user selecting a parameter, teaches wherein the at least one signal (sensor signals 24, fig. 2, [0035]) from the user input device (rotary knob 12, fig. 2, [0035]) comprises a rotation direction of the user input device ([0035] control device 22 included in the medical device 10 receives sensor signals 24 from the rotation angle sensor 16 and continuously determines a respective direction of rotation of the rotary knob 12 and a change in the angle of rotation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Iddon with the teachings of Landwehr to have the fluid actuation speed of Iddon set proportional to a speed at which a knob is turned, as taught by Landwehr, since both references deal with user interfaces for medical devices. Replacing the touchscreen user input device of Iddon, or replacing a touchscreen button of Iddon, with a knob as taught by Landwehr, would be a simple substitution of one user input device (a button on a touchscreen) for another user input device known in the art (the knob taught by Landwehr) and would have had predictable results to one of ordinary skill in the art. The device of Iddon as previously modified would still work with a knob instead of a touchscreen button.
Iddon as modified by Savage and Landwehr, as described above, discloses wherein rotation of the user input device (Savage: rotary knob 12, fig. 2) in one direction results in a same movement of the actuator (Iddon: piston associated with syringe 120, noted in [0064]) regardless of the orientation of the housing (see 112b interpretation above) (Examiner notes that the piston must move within the syringe, and furthermore is restrained to move longitudinally along the syringe whether filling or delivering fluid, therefore preforming a “same movement” in the same location and along the same axis, no matter the orientation of the housing.).
Regarding claim 45, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 44, as described above, including wherein the user input device includes at least one of a touchscreen (touch screen noted in [0083] as associated with the portable computer 150), a slider, a button, a knob, a dial and a microphone.
Regarding claim 47, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 44, as described above, including wherein the controller (portable computer 150, fig. 7) is remotely mounted from the housing (housing 125, fig. 7) ([0071] portable computer 150 is detachable from the injector housing 125 and may be utilized to operate the fluid injection system remotely from other positions in the room).
Regarding claim 48, Iddon modified by Savage discloses the fluid injector system of claim 44, as described above, including wherein the controller (portable computer 150, fig. 7) includes some components thereof that are remotely mounted from the housing (housing 125, fig. 7) ([0071] portable computer 150 is detachable from the injector housing 125 and may be utilized to operate the fluid injection system remotely from other positions in the room).
Claim(s) 6 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iddon modified by Savage and Landwehr, as applied to claim 1 or 16 above, and further in view of Morris et al (US 20030229311 A1; hereafter Morris).
Regarding claim 6, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1, as disclosed above, including the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors).
Iddon as modified is silent to the processor further configured to determine a load on the fluid actuator and adjust a resistance of the user input device based on the load.
Landwehr, in the art of medical devices and relating to a user selecting a parameter, teaches determining an effect (a measured value 34 for a parameter, fig. 2, [0072]); and
adjust a resistance (counter-torque noted in [0072]) of the user input device (knob 12, fig. 2, [0072]) based on the effect ([0072] the counter-torque effective when turning the rotary knob 12 depends on the parameter associated with the measured value 34).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Iddon to have a knob with applied counter-torque as a user input device as taught by Landwehr since both references deal with user interfaces for medical devices. Replacing the touchscreen user input device of Iddon, or replacing a touchscreen button of Iddon, with a knob as taught by Landwehr, would be a simple substitution of one user input device (a button on a touchscreen) for another user input device known in the art (the knob taught by Landwehr) and would have had predictable results to one of ordinary skill in the art. The device of Iddon as previously modified would still work with a knob instead of a touchscreen button. One would have been motivated to make the modification because, as noted in Landwehr [0072], the counter-torque gives the operator a physical feeling for the effect associated with an operating action, making the operator more aware of the effects their actions may have on the patient and thus improving patient safety.
Iddon as modified is silent to the effect being a load on the fluid actuator.
Morris, in the art of syringe plunger systems, teaches wherein a processor (processor noted in [0030]) is further configured to determine a load (force noted in [0030] as monitored by force detector 75, shown in fig. 7 and fig. 8) on the fluid actuator (plunger flange 46, fig. 7, [0030]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Iddon to have the processor configured to determine a load on the fluid actuator as taught by Morris since both references deal with syringe pumps. One would have been motivated to make the modification because, as noted by Morris, monitoring the force/load on the fluid actuator helps to alert the operator of possible occlusion events which may be dangerous for the patient as they indicate the device is not working properly.
Regarding claim 21, Iddon modified by Savage and Landwehr discloses the computer program product of claim 16, as described above, including wherein the one or more instructions further cause the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors) to:
Iddon as modified is silent wherein the one or more instructions further cause the at least one processor to determine a load on the fluid actuator and adjust a resistance of the user input device based on the load.
Landwehr, in the art of medical devices and relating to a user selecting a parameter, teaches determining an effect (a measured value 34 for a parameter, fig. 2, [0072]); and
adjust a resistance (counter-torque noted in [0072]) of the user input device (knob 12, fig. 2, [0072]) based on the effect ([0072] the counter-torque effective when turning the rotary knob 12 depends on the parameter associated with the measured value 34).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Iddon to have a knob with applied counter-torque as a user input device as taught by Landwehr since both references deal with user interfaces for medical devices. Replacing the touchscreen user input device of Iddon, or replacing a touchscreen button of Iddon, with a knob as taught by Landwehr, would be a simple substitution of one user input device (a button on a touchscreen) for another user input device known in the art (the knob taught by Landwehr) and would have had predictable results to one of ordinary skill in the art. The device of Iddon as previously modified would still work with a knob instead of a touchscreen button. One would have been motivated to make the modification because, as noted in Landwehr [0072], the counter-torque gives the operator a physical feeling for the effect associated with an operating action, making the operator more aware of the effects their actions may have on the patient and thus improving patient safety.
Iddon as modified is silent to the effect being a load on the fluid actuator.
Morris, in the art of syringe plunger systems, teaches wherein a processor (processor noted in [0030]) is further configured to determine a load (force noted in [0030] as monitored by force detector 75, shown in fig. 7 and fig. 8) on the fluid actuator (plunger flange 46, fig. 7, [0030]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Iddon to have the processor configured to determine a load on the fluid actuator as taught by Morris since both references deal with syringe pumps. One would have been motivated to make the modification because, as noted by Morris, monitoring the force/load on the fluid actuator helps to alert the operator of possible occlusion events which may be dangerous for the patient as they indicate the device is not working properly.
Claim(s) 7 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iddon modified by Savage and Landwehr, as applied to claim 1 or 16 above, and further in view of McDermott et al (WO 2019046267 A1; hereafter McDermott).
Regarding claim 7, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1, as disclosed above, including the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors).
Iddon as modified is silent to the processor further configured to determine a characteristic of the fluid path set and adjust the injection protocol based on a characteristic of the fluid path set.
McDermott, in the art of fluid injector systems, teaches wherein the at least one processor (processor of the fluid injection system, noted in [00114]) is further programmed or configured to:
determine at least one characteristic of a fluid path set ([00114] the system calculates the compliance of the system, see step 1250 in fig. 12); and
adjust at least one parameter (final drive member position X2, noted in [00114]) of the injection protocol (injection protocol, noted in [00114]) based on the at least one characteristic of the fluid path set ([00114] the system updates the final drive member position from the initial final drive member position X2 to a compliance corrected final drive member position X2' based on the calculated compliance, see step 1260 in fig. 12),
wherein the at least one characteristic of the fluid path set comprises a compliance rating of the fluid path set or of the fluid reservoir ([0069] system compliance/capacitance is inherent to each fluid delivery system and depends on the tubing dimensions; Examiner notes that the compliance of the system comprises the compliance of the fluid path set and the compliance of the fluid reservoir).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the processor of Iddon as modified to include the steps to determine and compensate for the fluid compliance of the fluid system as taught by McDermott, since McDermott also deals with fluid delivery using a syringe. One would have been motivated to make the modification because determining and compensating for the fluid compliance ensures that the correct volume of fluid is delivered to the patient, since as noted by [00114] of McDermott, the method is for correcting a fluid volume for an injection protocol, and as noted in [0007] of McDermott, the inaccuracies in a volume of fluid delivered to a patient may be due to impedance, compliance, and/or capacitance.
Regarding claim 22, Iddon modified by Savage and Landwehr discloses the computer program product of claim 16, as described above, including the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors).
Iddon as modified is silent wherein the one or more instructions further cause the at least one processor to determine a characteristic of the fluid path set and adjust the injection protocol based on a characteristic of the fluid path set.
McDermott, in the art of fluid injector systems, teaches wherein the at least one processor (processor of the fluid injection system, noted in [00114]) is further programmed or configured to:
determine at least one characteristic of a fluid path set ([00114] the system calculates the compliance of the system, see step 1250 in fig. 12); and
adjust at least one parameter (final drive member position X2, noted in [00114]) of the injection protocol (injection protocol, noted in [00114]) based on the at least one characteristic of the fluid path set ([00114] the system updates the final drive member position from the initial final drive member position X2 to a compliance corrected final drive member position X2' based on the calculated compliance, see step 1260 in fig. 12),
wherein the at least one characteristic of the fluid path set comprises a compliance rating of the fluid path set or of the fluid reservoir ([0069] system compliance/capacitance is inherent to each fluid delivery system and depends on the tubing dimensions; Examiner notes that the compliance of the system comprises the compliance of the fluid path set and the compliance of the fluid reservoir).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the processor of Iddon as modified to include the steps to determine and compensate for the fluid compliance of the fluid system as taught by McDermott, since McDermott also deals with fluid delivery using a syringe. One would have been motivated to make the modification because determining and compensating for the fluid compliance ensures that the correct volume of fluid is delivered to the patient, since as noted by [00114] of McDermott, the method is for correcting a fluid volume for an injection protocol, and as noted in [0007] of McDermott, the inaccuracies in a volume of fluid delivered to a patient may be due to impedance, compliance, and/or capacitance.
Claim(s) 9 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iddon modified by Savage, Landwehr, and McDermott as applied to claim 7 or 22 above, and further in view of Duchon et al (US 7169135 B2; hereafter Duchon).
Regarding claim 9, Iddon modified by Savage, Landwehr, and McDermott discloses the fluid injector system of claim 7, as described above.
Iddon as modified is silent to a scanner.
Duchon, in the art of fluid management and delivery, teaches a fluid injector system further comprising a scanner (bar-code reader noted in col. 14 ln. 58-col. 15 ln. 3, or noted in col. 11 ln. 41-54) configured to scan a tag (bar-code noted in col. 14 ln. 58-col. 15 ln. 3, or noted in col. 11 ln. 41-54) of the fluid path set to determine the at least one characteristic of the fluid path set (col. 14 ln. 58-col. 15 ln. 3, bottle size/volume is detected and automatically processed by the system 10; col. 11 ln. 41-54, bar-code reader reads a bar-code on syringe 18 and ensures that the syringe 18 is compatible with the system).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon as modified to include the bar-code with size and compatibility information and the bar-code reader taught by Duchon since Duchon also deals with fluid delivery via a syringe system. One would have been motivated to make the modification because automatically scanning parameters of the fluid path set would allow for verification of the compliance of the system as reasonable given the size of the reservoir, and as noted in Iddon [0069], the size of the syringe influences the compliance of the system and could be used to anticipate the system.
Regarding claim 24, Iddon modified by Savage, Landwehr, and McDermott discloses the computer program product of claim 22, as described above.
Iddon as modified is silent to scanning a tag to determine the characteristic.
Duchon, in the art of fluid management and delivery, teaches wherein determining the at least one characteristic of a fluid path set (see 112b interpretation above) (bottle size/volume noted in col. 14 ln. 58-col. 15 ln. 3) comprises scanning a tag (bar-code noted in col. 14 ln. 58-col. 15 ln. 3, or noted in col. 11 ln. 41-54) of the fluid path set (col. 14 ln. 58-col. 15 ln. 3, bottle size/volume is detected and automatically processed by the system 10; col. 11 ln. 41-54, bar-code reader reads a bar-code on syringe 18 and ensures that the syringe 18 is compatible with the system).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon as modified to include the bar-code with size and compatibility information and the bar-code reader taught by Duchon since Duchon also deals with fluid delivery via a syringe system. One would have been motivated to make the modification because automatically scanning parameters of the fluid path set would allow for verification of the compliance of the system as reasonable given the size of the reservoir, and as noted in Iddon [0069], the size of the syringe influences the compliance of the system and could be used to anticipate the system.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iddon modified by Savage and Landwehr, as applied to claim 1 above, and further in view of Fago et al (US 20050038386 A1; hereafter Fago).
Regarding claim 11, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1, as disclosed above. Iddon further discloses wherein the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors).
set a fluid actuation speed ([0066] injection flow rate may be selected by a user) based on at least one of:
the at least one signal from the user input device ([0066] the fluid control module, such as the touch screen of the detachable controller 150, may be used to operate user selected injection parameters such as injection flow rate; [0070] user may manipulate the flow rate and other parameters using the touch screen of the portable computer 150); and
a current status of the fluid injector system; and
actuate the fluid actuator (piston associated with syringe 120, noted in [0064]) at the fluid actuation speed ([0066] fluid flow from the at least one syringe 120 may be regulated by a fluid control module operated by a controller; Examiner notes that since the flow rate is stored in the controller 150 and the controller controls fluid flow from the syringe 120, the controller actuates the fluid actuator at the fluid actuation speed.).
Iddon as modified is silent to the fluid actuation speed being proportional to a speed at which the user input device is moved.
Landwehr, in the art of medical devices and relating to a user selecting a parameter, teaches wherein a parameter of a medical device (parameter noted in [0029]) is set proportional to a speed at which the user input device (knob 12, fig. 1, [0029]) is moved ([0029] A value detectable by means of the rotation angle sensor 16 regarding the position of the rotary knob 12 or a number of rotations of the rotary knob 12 or a rotation speed of the rotary knob 12, etc., is evaluated as a basis for setting a parameter of the medical device 10.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Iddon with the teachings of Landwehr to have the fluid actuation speed of Iddon set proportional to a speed at which a knob is turned, as taught by Landwehr, since both references deal with user interfaces for medical devices. Replacing the touchscreen user input device of Iddon, or replacing a touchscreen button of Iddon, with a knob as taught by Landwehr, would be a simple substitution of one user input device (a button on a touchscreen) for another user input device known in the art (the knob taught by Landwehr) and would have had predictable results to one of ordinary skill in the art. The device of Iddon as previously modified would still work with a knob instead of a touchscreen button. One would have been motivated to make the modification because the knob provides a more tactile method of adjusting a parameter and a user can manipulate the knob without looking directly at it, unlike with a touchscreen where they may need to keep their eyes on the screen lest their finger slip off of the user input portion of the screen.
Iddon as modified is silent to the rotation speed being proportional to the speed at which the user input device is moved.
Fago, in the art of medical injectors, teaches wherein a parameter (velocity of a plunger drive ram 46, noted in [0076]) of a medical device is set proportional to the user input ([0076] trigger 36 is rotated, see [0073] trigger 36 is rotated by hand) ([0076] plunger drive ram 46 moves at a velocity proportional to the angle of deflection of the trigger 36 away from the home position).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon as modified to further include the proportional relationship (taught by Fago) between the user input (rotation speed of rotary knob 12 taught by Landwehr) and the fluid actuation speed (disclosed by Iddon as controlled by user input) since Fago also deals with user control of fluid delivery, and specifically of the velocity of the fluid delivery system. One would have been motivated to make the modification because having a proportional relationship between the user input and device output would be intuitive for the user and would decrease the learning curve for using the device correctly.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iddon modified by Savage and Landwehr, as applied to claim 1 above, and further in view of Profio et al (US 20180140270 A1; hereafter Profio).
Regarding claim 13, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 1, as disclosed above, including the at least one processor (Iddon: [0069] portable computer 150 may include one or more processors).
Profio, in the field of medical imaging devices using contrast agents, teaches wherein the at least one processor (computing device 216, fig. 2, [0028]) is further programmed or configured to:
receive at least one additional signal from the user input device (operator console 220, fig. 2) ([0025] The computing device 216 receives the operator input including commands and/or scanning parameters via an operator console 220 operatively coupled to the computing device 216. The operator console 220 may include a keyboard or a touchscreen to allow the operator to specify the commands and/or scanning parameters.); and
adjust at least one of a height and the orientation of the housing based on the at least one additional signal ([0028] vertical and/or lateral position of the medical table can be adjusted by the controller 216 using operator-supplied parameters).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon to further include the processor configured to adjust the height of the medical device as taught by Profio because Profio deals with medical imaging and notes in [0017] that medical tables may be used with contrast agents for imaging, see fig. 1 and 2 of Profio. Additionally, Iddon teaches in [0067] that the injector may be part of a larger system, and that system may further be in communication with a medical scanner or imager, and Iddon [0064] notes that one of the fluids injected by the injector may be a contrast agent. Since the injector may be used as part of an imaging procedure which may involve adjusting the height of the patient, it would make sense to also be able to adjust the height of the injector housing of Iddon using the controller so that the operator could ensure the relative positions of the patient and the injector do not strain the fluid line and maintain the correct orientation of Iddon for injection/filling procedures as appropriate.
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iddon modified by Savage and Landwehr, as applied to claim 45 above, and further in view of Fago.
Regarding claim 46, Iddon modified by Savage and Landwehr discloses the fluid injector system of claim 45, as described above.
Iddon as modified notes that the user input device is portable (touch screen noted in [0083] is associated with the portable computer 150). Iddon is silent to the user input device located in a separate room from the housing.
Fago, in the art of medical injectors for contrast media, teaches wherein the user input device (remote console 44, fig. 1, [0189] remote console 44 allows the user to program or change programmed parameters) is one of: embedded in a scanner configured for performing a diagnostic imaging procedure on a patient; and in a separate room from the housing ([0189] The purpose of the remote console 44 is to provide the user a way to control and display the status of the device from a remote location, such as an imaging control room).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Iddon as modified to further include the user input device located in a separate room from the housing as taught by Fago since both deal with injection of contrast agents. One would have been motivated to make the modification because the imaging systems used with contrast agents may be harmful for the operator over prolonged, close contact.
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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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/06/2026