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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/19/2026 has been entered.
Response to Amendment
Applicant has amended claims 1, 10, and 19-20. No new matter has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 recites identical limitations to those already required in independent claim 1 from which it depends, and thus it is not further limiting on claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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(s) 1-2, 8, 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moberg et al. (US 20010034502, henceforth Moberg) in view of Kobayashi (US 20060079833, henceforth Kobayashi), Gray et al. (US 20110208123, henceforth Gray), Bar-El et al. (US 20200188576, henceforth Bar-El), and Muller-Pathle et al. (US 20130204224, henceforth Muller-Pathle).
Regarding claims 1 and 20, Moberg discloses an infusion pump (infusion pump 101, fig. 1) to deliver medicament to a patient ([0003]) comprising: a pump housing (housing 102, fig. 1) including a syringe receptacle (the space inside of housing 102 which is accessed via the opening of rear door 120 as shown in fig. 2 is a syringe receptacle as claimed) and being shaped and sized to accept loading of a syringe (see fig. 2, the space where reservoir 104 and its elements are located is shaped and sized to accept loading of reservoir 104 which makes up a syringe); an electrical motor (motor 111, fig. 3) having a variable output torque (since motor 111 can be activated or deactivated as disclosed in [0064]-[0066], it can have a variable output torque when it is either activated or deactivated) based on the electrical current input (the power supplied to motor 111 is what causes it to be activated or deactivated as controlled by controller 113, [0066]); a syringe drive assembly (drive system 138, fig. 3), including: a lead screw (lead screw 117, fig. 3) operably coupled with the electrical motor (see fig. 3, [0064], and [0067], lead screw 117 is operatively coupled to motor 111 as motor 111 drives lead screw 117); a plunger driver (one or more latch arms 119, fig. 3) operably coupled with the lead screw (see [0064], they are operatively coupled where rotation of the lead screw linearly translates latch arms 119) and linearly movable in response to rotation of the electrical motor (see [0064]), the plunger driver configured to push against a plunger of the syringe (see [0064], latch arms 119 are configured to push against slide 109 of reservoir 104); and a force sensor (sensor 134, fig. 3) configured to detect a force between the plunger driver and the plunger of the syringe (see [0067], sensor 134 is positioned to detect forces applied by lead screw 117 which is correlated with fluid pressure in reservoir 104, and since the forces applied by lead screw 117 to reservoir 104 are transferred via the interface of latch arms 119 and slide 109, this is disclosed); and a control module (programmable controller 113, fig. 2 and [0065]-[0067]) configured to regulate the electrical current input to the electrical motor ([0066], “the programmable controller 113 operates the motor 111 in a stepwise manner, typically on an intermittent basis; to administer discrete precise doses of the fluid to the user according to programmed delivery profiles”) based on the detected force between the plunger driver and the plunger of the syringe (see [0067], [0072], and [0098]; sensor 134 is used in part for occlusion detection, and occlusion detection causes fluid delivery to be stopped).
Moberg does not disclose that a portion of the plunger driver is external to the pump housing as claimed. Kobayashi teaches an infusion pump (syringe pump 1, fig. 1) having a pump housing (syringe pump body 2, fig. 1) and comprising a plunger driver (the plunger driver is made up of motor 9, gears 8a and 8b, ball screw member 7, and plunger presser 6 as shown in fig. 1) which has a portion which is external to the pump housing as claimed (see fig. 1, plunger presser extends externally to the pump body 2 as claimed). Kobayashi additionally teaches another form of a syringe receptacle (syringe holding portion 3, fig. 1) open to a front of the infusion pump (see fig. 1, the drawing is shown such that the front of the pump 1 is viewed, and holding portion 3 is open to the viewer) and being shaped and sized to accept loading of a syringe (see [0023] and [0024], the holding portion 3 is provided with concave 3a to hold syringe 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the syringe receptacle and plunger driver of Moberg to have been in the configuration of Kobayashi such as to allow the pump to work with syringes of different sizes and shapes (Kobayashi [0011]).
Moberg as modified by Kobayashi additionally discloses that its force sensor can instead be a sensor measuring distance ([0071]), and that when an occlusion is detected, current delivery to the plunger drive is suspended ([0098]).
Moberg as modified does not disclose the combined use of the force sensor and a plunger head sensor configured to determine a distance moved by the plunger driver as claimed. Gray teaches an infusion pump (infusion pump 100, fig. 1A) comprising a plunger head sensor (displacement detection device 218 is a plunger head sensor where it detects physical movement of the plunger head, fig. 2, [0318], [0351]) configured to determine a distance moved by a plunger driver ([0349], [0351]) wherein the sensor is used to determine mechanical failures and occlusions ([0318], [0349]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plunger head sensor of Gray to the modified infusion pump of Moberg for being able to detect mechanical failures in the infusion pump (Gray [0318], [0349]). Further, in keeping with Moberg where it discloses that mechanical failures should cause current delivery to be paused ([0098]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the modified infusion pump of Moberg such that the control module is configured to regulate the electrical current input to the electrical motor based on the distance moved by the plunger driver as detected by the added plunger head sensor of Gray when an occlusion is detected by stopping current delivery to prevent over dosing of drug (Moberg [0061] and [0098]).
Moberg as modified discloses the pump wherein the motor is a stepper motor ([0004]).
Moberg as modified does not disclose the pump wherein the control module applies a safety factor to the electrical current input, and wherein the control module decreases the safety factor based on the distance moved by the plunger driver for quieter operation of the infusion pump while continuing to deliver medicament. Bar-El teaches that it is desirable to reduce the noise produced by wearable infusion pumps ([0004]), and that one known way to achieve this desirable noise reduction is by reducing the speed of the motor ([0005]) while continuing to deliver medicament (see [0005], delivery rates can be restricted but are not set to zero). Further, Muller-Pathle teaches that motor speed is changeable for stepper motors and output torque is changeable depending on the applied current (see [0012] and [0045]). Further, Muller-Pathle teaches that reduced levels of output torque are required for infusion pumps as the plunger driver gets further away from the initial position because there is less pressure required for medicament infusion once the delivery gets underway due to static friction ([0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the control module of Moberg as modified to have applied a safety factor (or a factor that the maximum value is reduced by) to the electrical current input based on the distance moved by the plunger driver so as to only provide the required torque by only providing the minimally required input current as in Muller-Pathle (see [0045] and [0072]) such as to achieve the maximum desirable noise reduction as in Bar-El (see [0004] and [0005]). Such a modification would be based on the distance moved by the plunger driver as claimed where it would be based on whether or not the driver was in motion as measured by the distance moved by the plunger driver, as the plunger driver being in motion would mean that the increased motor speed and torque at startup could be removed by applying a safety factor to the initial input current value to reduce the current value and thus the motor speed and output torque because static friction would already be overcome (see at least Muller-Pathle [0072]).
Regarding claim 2, Moberg as modified discloses the pump wherein the electrical current input is incrementally reduced according to defined magnitudes of detected force (see [0015], [0067], [0072], and [0098]; sensor 134 is used in part for occlusion detection, and occlusion detection is declared at 2.00 pounds of force and causes fluid delivery to be stopped; this is a reduction from an amount of current required to drive the motor 111 to zero such as to stop the motor, which is an incremental reduction, according to a set magnitude of detected force which is the occlusion threshold).
Regarding claim 8, Moberg as modified discloses the pump wherein the electrical current input is reduced according to a nonlinear function of the detected force (since the reduction of the electrical current input as in claim 1 is a stepwise reduction where the input current is either activated or deactivated, it is reduced nonlinearly since it is a stepwise pattern).
Regarding claim 10, Moberg discloses a method of operating an infusion pump (infusion pump 101, fig. 1) to deliver medicament to a patient ([0003]) the method comprising: providing, by a control module (programmable controller 113, fig. 2 and [0065]-[0067]), an electrical current input (electrical power is supplied to motor 111 as disclosed in [0065] and [0066], this is an electrical current input) to an electrical motor of the infusion pump (motor 111, fig. 3;) so as to cause a plunger driver of the infusion pump (one or more latch arms 119, fig. 3) to push against a plunger (see [0064], latch arms 119 are configured to push against slide 109 of reservoir 104) of a syringe (reservoir 104, fig. 2) installed in the infusion pump (see fig. 2), wherein the electrical motor includes a variable output torque (since motor 111 can be activated or deactivated as disclosed in [0064]-[0066], it can have a variable output torque when it is either activated or deactivated) based on the electrical current input (the power supplied to motor 111 is what causes it to be activated or deactivated as controlled by controller 113, [0066]); detecting a force between the plunger driver and the plunger of the syringe (see [0067], sensor 134 is positioned to detect forces applied by lead screw 117 which is correlated with fluid pressure in reservoir 104, and since the forces applied by lead screw 117 to reservoir 104 are transferred via the interface of latch arms 119 and slide 109, this is disclosed) using a force sensor (sensor 134, fig. 3); and modulating, by the control module, the electrical current input to the electrical motor ([0066], “the programmable controller 113 operates the motor 111 in a stepwise manner, typically on an intermittent basis; to administer discrete precise doses of the fluid to the user according to programmed delivery profiles”) based on the detected force between the plunger driver and the plunger of the syringe (see [0067], [0072], and [0098]; sensor 134 is used in part for occlusion detection, and occlusion detection causes fluid delivery to be stopped).
Moberg does not disclose that a portion of the plunger driver is external to the pump housing as claimed. Kobayashi teaches an infusion pump (syringe pump 1, fig. 1) having a pump housing (syringe pump body 2, fig. 1) and comprising a plunger driver (the plunger driver is made up of motor 9, gears 8a and 8b, ball screw member 7, and plunger presser 6 as shown in fig. 1) which has a portion which is external to the pump housing as claimed (see fig. 1, plunger presser extends externally to the pump body 2 as claimed). Kobayashi additionally teaches another form of a syringe receptacle (syringe holding portion 3, fig. 1) open to a front of the infusion pump (see fig. 1, the drawing is shown such that the front of the pump 1 is viewed, and holding portion 3 is open to the viewer) and being shaped and sized to accept loading of a syringe (see [0023] and [0024], the holding portion 3 is provided with concave 3a to hold syringe 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the syringe receptacle and plunger driver of Moberg to have been in the configuration of Kobayashi such as to allow the pump to work with syringes of different sizes and shapes (Kobayashi [0011]).
Moberg as modified by Kobayashi additionally discloses that its force sensor can instead be a sensor measuring distance ([0071]), and that when an occlusion is detected, current delivery to the plunger drive is suspended ([0098]).
Moberg as modified does not disclose the combined use of the force sensor and a plunger head sensor configured to determine a distance moved by the plunger driver as claimed. Gray teaches an infusion pump (infusion pump 100, fig. 1A) comprising a plunger head sensor (displacement detection device 218 is a plunger head sensor where it detects physical movement of the plunger head, fig. 2, [0318], [0351]) configured to determine a distance moved by a plunger driver ([0349], [0351]) wherein the sensor is used to determine mechanical failures and occlusions ([0318], [0349]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plunger head sensor of Gray to the modified infusion pump of Moberg for being able to detect mechanical failures in the infusion pump (Gray [0318], [0349]). Further, in keeping with Moberg where it discloses that mechanical failures should cause current delivery to be paused ([0098]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the modified infusion pump of Moberg such that the control module is configured to regulate the electrical current input to the electrical motor based on the distance moved by the plunger driver as detected by the added plunger head sensor of Gray when an occlusion is detected by stopping current delivery to prevent over dosing of drug (Moberg [0061] and [0098]).
Moberg as modified discloses the pump wherein the motor is a stepper motor ([0004]).
Moberg as modified does not disclose the pump wherein the control module applies a safety factor to the electrical current input, and wherein the control module decreases the safety factor based on the distance moved by the plunger driver for quieter operation of the infusion pump while continuing to deliver medicament. Bar-El teaches that it is desirable to reduce the noise produced by wearable infusion pumps ([0004]), and that one known way to achieve this desirable noise reduction is by reducing the speed of the motor ([0005]) while continuing to deliver medicament (see [0005], delivery rates can be restricted but are not set to zero). Further, Muller-Pathle teaches that motor speed is changeable for stepper motors and output torque is changeable depending on the applied current (see [0012] and [0045]). Further, Muller-Pathle teaches that reduced levels of output torque are required for infusion pumps as the plunger driver gets further away from the initial position because there is less pressure required for medicament infusion once the delivery gets underway due to static friction ([0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the control module of Moberg as modified to have applied a safety factor (or a factor that the maximum value is reduced by) to the electrical current input based on the distance moved by the plunger driver so as to only provide the required torque by only providing the minimally required input current as in Muller-Pathle (see [0045] and [0072]) such as to achieve the maximum desirable noise reduction as in Bar-El (see [0004] and [0005]). Such a modification would be based on the distance moved by the plunger driver as claimed where it would be based on whether or not the driver was in motion as measured by the distance moved by the plunger driver, as the plunger driver being in motion would mean that the increased motor speed and torque at startup could be removed by applying a safety factor to the initial input current value to reduce the current value and thus the motor speed and output torque because static friction would already be overcome (see at least Muller-Pathle [0072]).
Claim(s) 3-7, 9, and 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moberg et al. (US 20010034502, henceforth Moberg) in view of Kobayashi (US 20060079833, henceforth Kobayashi), Gray et al. (US 20110208123, henceforth Gray), Bar-El et al. (US 20200188576, henceforth Bar-El), and Muller-Pathle et al. (US 20130204224, henceforth Muller-Pathle) as applied to claims 1 and 10 above, and further in view of Neer et al. (WO 2010027636, henceforth Neer) and Brundle et al. (WO 2005093533, henceforth Brundle).
Regarding claims 3 and 12, Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle discloses the use of force measurements and the pressures which they are indicative of as a means for detecting an occlusion (see [0067], [0071]-[0072], and [0098]).
Moberg as modified does not disclose that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics. Neer teaches that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics (see pg. 6 lines 5-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the calibration technique of Neer with the infusion pump of Moberg to allow for fewer processing resources to be used to determine whether or not the pump is in proper operating status as compared to doing calculations (see Neer pg. 25 lines 5-27).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer discloses that the motor can be a stepper motor (see Moberg [0004] and [0065], the motor can be a stepper motor in the chosen embodiment).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer does not explicitly disclose varying the amounts of electrical current input to a stepper motor to accommodate for varying loads. Brundle teaches that stepper motors can be fed with varying amounts of input electrical current such as to provide different amounts of torque such that a desired speed of injection can be maintained for a given force which is measured by a force sensor (see at least Brundle pg. 3 lines 2-9 regarding varying electrical currents to overcome torque values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the amount of electrical current input to the motor as in Brundle when trying to administer the contents of the syringe and overcome a measured force such as to meet the calibrated measurements of Neer.
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, Neer, and Brundle does not explicitly disclose the pump wherein the electrical current input is maintained at a maximum rated power input when the detected force is greater than or equal to about 80 N. However, Moberg discloses that different levels of force are meant to be measured by the sensor and are meant to be provided by the motor depending on specific characteristics and variables of the given system (see [0079], different levels of force are a result effective variable depending on factors such as fluid concentration, force required for the drive train, reservoir diameter, etc.), Neer discloses in the modified system that different amounts of power such as to provide different amounts of force from the motor should be provided as needed to overcome a resistant force from the assembly (see at least Neer pg. 21 lines 7-37, “The power injector 10 may adjust the level of force present on the ram 74 of the power injector 10 by controlling the injector calibration apparatus motor 114. Control of the injector calibration apparatus motor 114 may be achieved by adjusting an electrical signal from the power injector 10 to the drive circuit 142”), and Brundle discloses that varying amounts of current should be provided to overcome resistant force to prevent stalling (see Brundle pg. 1 line 30 – pg. 2 line 4).
Thus, in the modified pump and method of use thereof, the measured forces are held to be a result effective variable as is the amount of power required to overcome such a force since this power is dependent on motor characteristics and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the electrical input current as claimed when the detected force is the claimed value depending on the characteristics of the given system such as to allow for proper injection to occur and not cause stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4), especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed force values or amount of power to be input to the motor, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see [0010], [0047], and [0049] of Applicant’s disclosure as displayed in US 20230104401).
Regarding claims 4 and 13, Moberg as modified does not explicitly disclose the pump wherein the maximum rated power input is about 0.7 A. However, Brundle discloses as a part of the modified apparatus and method of use thereof that the amount of power to be dissipated by the motor is dependent on the type of motor and amount of force it needs to provide (see Brundle pg. 1 line 30 – pg. 2 line 4 and note that the specific design of a stepper motor is a type of motor).
Thus, in the modified pump and method of use thereof, the maximum rated power input of the electrical current input to be delivered to the motor is held to be a result effective variable since this power is dependent on motor characteristics and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the maximum rated power input as claimed such as to provide enough force to allow the motor to move the plunger driver and allow for proper injection to occur and without stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4) depending on the characteristics of the given system especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed maximum rated power input, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see at least [0008], [0047], and [0053] of Applicant’s disclosure as displayed in US 20230104401).
Regarding claims 5 and 14, Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle discloses the use of force measurements and the pressures which they are indicative of as a means for detecting an occlusion (see [0067], [0071]-[0072], and [0098]).
Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle does not disclose that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics. Neer teaches that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics (see pg. 6 lines 5-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the calibration technique of Neer with the infusion pump of Moberg to allow for fewer processing resources to be used to determine whether or not the pump is in proper operating status as compared to doing calculations (see Neer pg. 25 lines 5-27).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer discloses that the motor can be a stepper motor (see Moberg [0004] and [0065], the motor can be a stepper motor in the chosen embodiment).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer does not explicitly disclose varying the amounts of electrical current input to a stepper motor to accommodate for varying loads. Brundle teaches that stepper motors can be fed with varying amounts of input electrical current such as to provide different amounts of torque such that a desired speed of injection can be maintained for a given force which is measured by a force sensor (see at least Brundle pg. 3 lines 2-9 regarding varying electrical currents to overcome torque values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the amount of electrical current input to the motor as in Brundle when trying to administer the contents of the syringe and overcome a measured force such as to meet the calibrated measurements of Neer.
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, Neer, and Brundle does not explicitly disclose the pump wherein the electrical current input is reduced to about 75% of its maximum rated power input when the detected force less than about 80 N. However, Moberg discloses that different levels of force are meant to be measured by the sensor and are meant to be provided by the motor depending on specific characteristics and variables of the given system (see [0079], different levels of force are a result effective variable depending on factors such as fluid concentration, force required for the drive train, reservoir diameter, etc.), Neer discloses in the modified system that different amounts of power such as to provide different amounts of force from the motor should be provided as needed to overcome a resistant force from the assembly (see at least Neer pg. 21 lines 7-37, “The power injector 10 may adjust the level of force present on the ram 74 of the power injector 10 by controlling the injector calibration apparatus motor 114. Control of the injector calibration apparatus motor 114 may be achieved by adjusting an electrical signal from the power injector 10 to the drive circuit 142”), and Brundle discloses that varying amounts of current should be provided to overcome resistant force to prevent stalling (see Brundle pg. 1 line 30 – pg. 2 line 4).
Thus, in the modified pump and method of use thereof, the measured forces are held to be a result effective variable as is the amount of power required to overcome such a force since this power is dependent on motor characteristics and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the electrical input current as claimed when the detected force is the claimed value depending on the characteristics of the given system such as to allow for proper injection to occur and not cause stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4), especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed force values or amount of power to be input to the motor, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see [0010], [0042], and [0054] of Applicant’s disclosure as displayed in US 20230104401).
Regarding claims 6 and 15, Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle discloses the use of force measurements and the pressures which they are indicative of as a means for detecting an occlusion (see [0067], [0071]-[0072], and [0098]).
Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle does not disclose that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics. Neer teaches that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics (see pg. 6 lines 5-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the calibration technique of Neer with the infusion pump of Moberg to allow for fewer processing resources to be used to determine whether or not the pump is in proper operating status as compared to doing calculations (see Neer pg. 25 lines 5-27).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer discloses that the motor can be a stepper motor (see Moberg [0004] and [0065], the motor can be a stepper motor in the chosen embodiment).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer does not explicitly disclose varying the amounts of electrical current input to a stepper motor to accommodate for varying loads. Brundle teaches that stepper motors can be fed with varying amounts of input electrical current such as to provide different amounts of torque such that a desired speed of injection can be maintained for a given force which is measured by a force sensor (see at least Brundle pg. 3 lines 2-9 regarding varying electrical currents to overcome torque values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the amount of electrical current input to the motor as in Brundle when trying to administer the contents of the syringe and overcome a measured force such as to meet the calibrated measurements of Neer.
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, Neer, and Brundle does not explicitly disclose the pump wherein the electrical current input is reduced to about 50% of its maximum rated power input when the detected force less than about 65 N. However, Moberg discloses that different levels of force are meant to be measured by the sensor and are meant to be provided by the motor depending on specific characteristics and variables of the given system (see [0079], different levels of force are a result effective variable depending on factors such as fluid concentration, force required for the drive train, reservoir diameter, etc.), Neer discloses in the modified system that different amounts of power such as to provide different amounts of force from the motor should be provided as needed to overcome a resistant force from the assembly (see at least Neer pg. 21 lines 7-37, “The power injector 10 may adjust the level of force present on the ram 74 of the power injector 10 by controlling the injector calibration apparatus motor 114. Control of the injector calibration apparatus motor 114 may be achieved by adjusting an electrical signal from the power injector 10 to the drive circuit 142”), and Brundle discloses that varying amounts of current should be provided to overcome resistant force to prevent stalling (see Brundle pg. 1 line 30 – pg. 2 line 4).
Thus, in the modified pump and method of use thereof, the measured forces are held to be a result effective variable as is the amount of power required to overcome such a force since this power is dependent on motor characteristics and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the electrical input current as claimed when the detected force is the claimed value depending on the characteristics of the given system such as to allow for proper injection to occur and not cause stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4), especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed force values or amount of power to be input to the motor, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see [0010], [0042], and [0055] of Applicant’s disclosure as displayed in US 20230104401).
Regarding claims 7 and 16, Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle discloses the use of force measurements and the pressures which they are indicative of as a means for detecting an occlusion (see [0067], [0071]-[0072], and [0098]).
Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle does not disclose that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics. Neer teaches that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics (see pg. 6 lines 5-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the calibration technique of Neer with the infusion pump of Moberg to allow for fewer processing resources to be used to determine whether or not the pump is in proper operating status as compared to doing calculations (see Neer pg. 25 lines 5-27).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer discloses that the motor can be a stepper motor (see Moberg [0065], the motor can be a stepper motor in the chosen embodiment).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer does not explicitly disclose varying the amounts of electrical current input to a stepper motor to accommodate for varying loads. Brundle teaches that stepper motors can be fed with varying amounts of input electrical current such as to provide different amounts of torque such that a desired speed of injection can be maintained for a given force which is measured by a force sensor (see at least Brundle pg. 3 lines 2-9 regarding varying electrical currents to overcome torque values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the amount of electrical current input to the motor as in Brundle when trying to administer the contents of the syringe and overcome a measured force such as to meet the calibrated measurements of Neer.
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, Neer, and Brundle does not explicitly disclose the pump wherein the electrical current input is reduced to about 25% of its maximum rated power input when the detected force is negligible. However, Moberg discloses that different levels of force are meant to be measured by the sensor and are meant to be provided by the motor depending on specific characteristics and variables of the given system (see [0079], different levels of force are a result effective variable depending on factors such as fluid concentration, force required for the drive train, reservoir diameter, etc.), Neer discloses in the modified system that different amounts of power such as to provide different amounts of force from the motor should be provided as needed to overcome a resistant force from the assembly (see at least Neer pg. 21 lines 7-37, “The power injector 10 may adjust the level of force present on the ram 74 of the power injector 10 by controlling the injector calibration apparatus motor 114. Control of the injector calibration apparatus motor 114 may be achieved by adjusting an electrical signal from the power injector 10 to the drive circuit 142”), and Brundle discloses that varying amounts of current should be provided to overcome resistant force to prevent stalling (see Brundle pg. 1 line 30 – pg. 2 line 4).
Thus, in the modified pump and method of use thereof, the measured forces are held to be a result effective variable as is the amount of power required to overcome such a force since this power is dependent on motor characteristics and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the electrical input current as claimed when the detected force is the claimed value depending on the characteristics of the given system such as to allow for proper injection to occur and not cause stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4), especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed force values or amount of power to be input to the motor, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see [0010], [0042], and [0043] of Applicant’s disclosure as displayed in US 20230104401).
Regarding claims 9 and 11, Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle discloses the use of force measurements and the pressures which they are indicative of as a means for detecting an occlusion (see [0067], [0071]-[0072], and [0098]).
Moberg as modified by Kobayashi, Gray, Bar-El, and Muller-Pathle does not disclose that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics. Neer teaches that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics (see pg. 6 lines 5-23), and that different speeds can be used (see pg. 6 lines 1-10) which should be measured and calibrated for (see pg. 19 lines 3-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the calibration technique of Neer with the infusion pump of Moberg to allow for fewer processing resources to be used to determine whether or not the pump is in proper operating status as compared to doing calculations (see Neer pg. 25 lines 5-27).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer thus discloses the pump with the syringe drive assembly further comprising: the plunger head sensor (sensor added from Gray as in claim 1) configured to detect a linear rate of travel of the plunger driver (see Gray [0318] and [0349], displacement detection device 218 is configured to detect the rate of travel of the plunger driver as claimed where it is configured to detect at least if an occlusion is occurring which would be a rate of travel of 0), wherein the control module is further configured to regulate the electrical current input to the electrical motor based on the linear rate of travel of the plunger driver as detected by the plunger head sensor (see the rejections of claims 1 and 10 above, the controller in the modified device would be configured to stop injections when the rate of travel of the plunger driver as detected by the plunger head sensor is equal to 0 due to occlusions preventing fluid infusion).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer discloses that the motor can be a stepper motor (see Moberg [0065], the motor can be a stepper motor in the chosen embodiment).
Moberg as modified by Kobayashi, Gray, Bar-El, Muller-Pathle, and Neer does not explicitly disclose varying the amounts of electrical current input to a stepper motor to accommodate for varying loads. Brundle teaches that stepper motors can be fed with varying amounts of input electrical current such as to provide different amounts of torque such that a desired speed of injection can be maintained for a given force which is measured by a force sensor (see at least Brundle pg. 3 lines 2-9 regarding varying electrical currents to overcome torque values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the amount of electrical current input to the motor as in Brundle when trying to administer the contents of the syringe and overcome a measured force such as to meet the calibrated measurements of Neer.
Regarding claim 17, Moberg as modified does not explicitly disclose the method wherein the electrical current input is modulated at about 75% of its maximum rated power input when the detected force is greater than about 30 N and the detected rate of travel is greater than about 108 millimeters per hour. However, Moberg discloses that different levels of force are meant to be measured by the sensor and are meant to be provided by the motor depending on specific characteristics and variables of the given system (see [0079], different levels of force are a result effective variable depending on factors such as fluid concentration, force required for the drive train, reservoir diameter, etc.), Neer discloses in the modified system that different amounts of power such as to provide different amounts of force from the motor should be provided as needed to overcome a resistant force from the assembly (see at least Neer pg. 21 lines 7-37, “The power injector 10 may adjust the level of force present on the ram 74 of the power injector 10 by controlling the injector calibration apparatus motor 114. Control of the injector calibration apparatus motor 114 may be achieved by adjusting an electrical signal from the power injector 10 to the drive circuit 142”), and Brundle discloses that varying amounts of current should be provided to overcome resistant force to prevent stalling (see Brundle pg. 1 line 30 – pg. 2 line 4).
Thus, in the modified pump and method of use thereof, the measured forces are held to be a result effective variable as is the amount of power required to overcome a resistive force since this power is dependent on motor characteristics including desired speed and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the electrical input current as claimed when the detected force is the claimed value and when the detected speed is the claimed value or greater depending on the characteristics of the given system such as to allow for proper injection to occur and not cause stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4), especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed force values, amount of power to be input to the motor, or rate of travel, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see [0056] of Applicant’s disclosure as displayed in US 20230104401).
Regarding claim 18, Moberg as modified does not explicitly disclose the method wherein the electrical current input is modulated at about 50% of its maximum rated power input when the detected force is less than about 64 N and the detected rate of travel is less than about 108 millimeters per hour. However, Moberg discloses that different levels of force are meant to be measured by the sensor and are meant to be provided by the motor depending on specific characteristics and variables of the given system (see [0079], different levels of force are a result effective variable depending on factors such as fluid concentration, force required for the drive train, reservoir diameter, etc.), Neer discloses in the modified system that different amounts of power such as to provide different amounts of force from the motor should be provided as needed to overcome a resistant force from the assembly (see at least Neer pg. 21 lines 7-37, “The power injector 10 may adjust the level of force present on the ram 74 of the power injector 10 by controlling the injector calibration apparatus motor 114. Control of the injector calibration apparatus motor 114 may be achieved by adjusting an electrical signal from the power injector 10 to the drive circuit 142”), and Brundle discloses that varying amounts of current should be provided to overcome resistant force to prevent stalling (see Brundle pg. 1 line 30 – pg. 2 line 4).
Thus, in the modified pump and method of use thereof, the measured forces are held to be a result effective variable as is the amount of power required to overcome a resistive force since this power is dependent on motor characteristics including desired speed and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the electrical input current as claimed when the detected force is the claimed value and when the detected speed is the claimed value or greater depending on the characteristics of the given system such as to allow for proper injection to occur and not cause stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4), especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed force values, amount of power to be input to the motor, or rate of travel, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see [0056] of Applicant’s disclosure as displayed in US 20230104401).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moberg et al. (US 20010034502, henceforth Moberg) in view of Kobayashi (US 20060079833, henceforth Kobayashi), Gray et al. (US 20110208123, henceforth Gray), Neer et al. (WO 2010027636, henceforth Neer), and Brundle et al. (WO 2005093533, henceforth Brundle).
Regarding claim 19, Moberg discloses an infusion pump (infusion pump 101, fig. 1) to deliver medicament to a patient ([0003]) configured to modulate an electrical current input (electrical power is supplied to motor 111 as disclosed in [0065] and [0066], this is an electrical current input) of a drive motor (motor 111, fig. 3; the configuration for modulation is disclosed in [0065] and [0066] where it is disclosed that controller 113 operates motor 111 in a stepwise manner on an intermittent basis, this is a modulation since it is a controlled changing), the infusion pump comprising: a pump housing (housing 102, fig. 1) defining a syringe receptacle (the space inside of housing 102 which is accessed via the opening of rear door 120 as shown in fig. 2 is a syringe receptacle as claimed) shaped and sized to accept loading of a syringe (see fig. 2, the space where reservoir 104 and its elements are located is shaped and sized to accept loading of reservoir 104 which makes up a syringe); an electrical motor (motor 111, fig. 3; see the rejection under 35 U.S.C. § 112(b) above regarding the claimed motors) having a variable output torque (since motor 111 can be activated or deactivated as disclosed in [0064]-[0066], it can have a variable output torque when it is either activated or deactivated) based on the electrical current input (the power supplied to motor 111 is what causes it to be activated or deactivated as controlled by controller 113, [0066]); a syringe drive assembly (drive system 138, fig. 3), including: a lead screw (lead screw 117, fig. 3) operably coupled with the electrical motor (see fig. 3, [0064], and [0067], lead screw 117 is operatively coupled to motor 111 as motor 111 drives lead screw 117); a plunger driver (one or more latch arms 119, fig. 3) operably coupled with the lead screw (see [0064], they are operatively coupled where rotation of the lead screw linearly translates latch arms 119) and linearly movable in response to rotation of the electrical motor (see [0064]), the plunger driver configured to push against a plunger of the syringe (see [0064], latch arms 119 are configured to push against slide 109 of reservoir 104); a force sensor (sensor 134, fig. 3) configured to detect a force between the plunger driver and the plunger of the syringe (see [0067], sensor 134 is positioned to detect forces applied by lead screw 117 which is correlated with fluid pressure in reservoir 104, and since the forces applied by lead screw 117 to reservoir 104 are transferred via the interface of latch arms 119 and slide 109, this is disclosed); and a control module (programmable controller 113, fig. 2 and [0065]-[0067]) configured to regulate the electrical current input to the electrical motor ([0066], “the programmable controller 113 operates the motor 111 in a stepwise manner, typically on an intermittent basis; to administer discrete precise doses of the fluid to the user according to programmed delivery profiles”) based on the detected force between the plunger driver and the plunger of the syringe (see [0067], [0072], and [0098]; sensor 134 is used in part for occlusion detection, and occlusion detection causes fluid delivery to be stopped). Moberg additionally discloses the use of force measurements and the pressures which they are indicative of as a means for detecting an occlusion (see [0067], [0071]-[0072], and [0098]).
Moberg does not disclose that a portion of the plunger driver is external to the pump housing as claimed. Kobayashi teaches an infusion pump (syringe pump 1, fig. 1) having a pump housing (syringe pump body 2, fig. 1) and comprising a plunger driver (the plunger driver is made up of motor 9, gears 8a and 8b, ball screw member 7, and plunger presser 6 as shown in fig. 1) which has a portion which is external to the pump housing as claimed (see fig. 1, plunger presser extends externally to the pump body 2 as claimed). Kobayashi additionally teaches another form of a syringe receptacle (syringe holding portion 3, fig. 1) open to a front of the infusion pump (see fig. 1, the drawing is shown such that the front of the pump 1 is viewed, and holding portion 3 is open to the viewer) and being shaped and sized to accept loading of a syringe (see [0023] and [0024], the holding portion 3 is provided with concave 3a to hold syringe 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the syringe receptacle and plunger driver of Moberg to have been in the configuration of Kobayashi such as to allow the pump to work with syringes of different sizes and shapes (Kobayashi [0011]).
Moberg as modified by Kobayashi additionally discloses that its force sensor can instead be a sensor measuring distance ([0071]), and that when an occlusion is detected, current delivery to the plunger drive is suspended ([0098]).
Moberg as modified does not disclose the combined use of the force sensor and a plunger head sensor configured to determine a distance moved by the plunger driver as claimed. Gray teaches an infusion pump (infusion pump 100, fig. 1A) comprising a plunger head sensor (displacement detection device 218 is a plunger head sensor where it detects physical movement of the plunger head, fig. 2, [0318], [0351]) configured to determine a distance moved by a plunger driver ([0349], [0351]) wherein the sensor is used to determine mechanical failures and occlusions ([0318], [0349]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plunger head sensor of Gray to the modified infusion pump of Moberg for being able to detect mechanical failures in the infusion pump (Gray [0318], [0349]). Further, in keeping with Moberg where it discloses that mechanical failures should cause current delivery to be paused ([0098]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the modified infusion pump of Moberg such that the control module is configured to regulate the electrical current input to the electrical motor based on the distance moved by the plunger driver as detected by the added plunger head sensor of Gray when an occlusion is detected by stopping current delivery to prevent over dosing of drug (Moberg [0061] and [0098]).
Moberg as modified by Kobayashi and Gray thus discloses the pump with the syringe drive assembly further comprising: the plunger head sensor (sensor added from Gray as in claim 1) configured to detect a linear rate of travel of the plunger driver (see Gray [0318] and [0349], displacement detection device 218 is configured to detect the rate of travel of the plunger driver as claimed where it is configured to detect at least if an occlusion is occurring which would be a rate of travel of 0), wherein the control module is further configured to regulate the electrical current input to the electrical motor based on the linear rate of travel of the plunger driver as detected by the plunger head sensor (see the rejections of claims 1 and 10 above, the controller in the modified device would be configured to stop injections when the rate of travel of the plunger driver as detected by the plunger head sensor is equal to 0 due to occlusions preventing fluid infusion).
Moberg as modified does not disclose that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics. Neer teaches that different forces and pressures which the forces are indicative of can occur for the same rate of injection as a result of different infusion characteristics (see pg. 6 lines 5-23), and that different speeds can be used (see pg. 6 lines 1-10) which should be measured and calibrated for (see pg. 19 lines 3-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the calibration technique of Neer with the infusion pump of Moberg to allow for fewer processing resources to be used to determine whether or not the pump is in proper operating status as compared to doing calculations (see Neer pg. 25 lines 5-27).
Moberg as modified by Kobayashi, Gray, and Neer discloses that the motor can be a stepper motor (see Moberg [0065], the motor can be a stepper motor in the chosen embodiment).
Moberg as modified does not explicitly disclose varying the amounts of electrical current input to a stepper motor to accommodate for varying loads. Brundle teaches that stepper motors can be fed with varying amounts of input electrical current such as to provide different amounts of torque such that a desired speed of injection can be maintained for a given force which is measured by a force sensor (see at least Brundle pg. 3 lines 2-9 regarding varying electrical currents to overcome torque values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the amount of electrical current input to the motor as in Brundle when trying to administer the contents of the syringe and overcome a measured force such as to meet the calibrated measurements of Neer.
Moberg as modified by Kobayashi, Gray, Neer, and Brundle discloses the pump wherein the electrical current input is incrementally reduced according to defined magnitudes of detected force (since the modified device of Moberg incorporates the teachings of Neer and Brundle in particular where the amount of current supplied is based on the amount of current required to overcome resistant force from the system according to calibrated values for the given system, the electrical current input is incrementally reduced where the current is scaled down as needed which is determined according to defined magnitudes of detected force since those measured values are used to determine where in the calibrated lookup tables the amount of current to be supplied is chosen from).
While Moberg as modified does not explicitly disclose a maximum rated power input for the drive motor is less than about 1.0 A, Brundle discloses as a part of the modified apparatus that the amount of power to be dissipated by the motor is dependent on the type of motor and amount of force it needs to provide (see Brundle pg. 1 line 30 – pg. 2 line 4 and note that the specific design of a stepper motor is a type of motor).
Thus, in the modified pump and method of use thereof, the maximum rated power input of the electrical current input to be delivered to the motor is held to be a result effective variable since this power is dependent on motor characteristics and the amount of force required to be overcome, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the maximum rated power input as claimed such as to provide enough force to allow the motor to move the plunger driver and allow for proper injection to occur and without stalling of the motor (see at least Neer pg. 25 lines 9-16 and Brundle pg. 1 line 30 – pg. 2 line 4) depending on the characteristics of the given system especially since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Further, while Moberg as modified does not explicitly disclose the claimed maximum rated power input, the provided disclosure sets forth the claimed values merely as exemplary values and does not assign criticality or novelty to these values (see at least [0008], [0016], and Table 1 of Applicant’s disclosure as displayed in US 20230104401).
Response to Arguments
Applicant's arguments filed 03/19/2026 have been fully considered but they are not persuasive.
Applicant argues that it would not have been obvious to modify Moberg as provided above with respect to Gray and Kobayashi because it could allow a user to dislodge the syringe from the pump or bump the driver to reduce accuracy, and because Moberg describes water resistance which would be destroyed by the modifications made above. Examiner respectfully disagrees. The loading of the syringe from Kobayashi and modification made to the housing could be designed by one of ordinary skill in the art such that the syringe is still stably mounted on the pump device and the pump device is still readily carried by a user. Kobayashi additionally teaches the plunger driver extending into and out of the device, and thus it is considered that the plunger driver is securely mounted in the modified device as well such that minor bumps or jostling would not render the device ineffective and would still yield the benefit of allowing the device to work with syringes of different sizes. Regarding the arguments drawn towards water resistance, Examiner notes that Moberg teaches that the sensor and motor must be made water resistant through use of a seal, which is not prohibited in the modified device (Moberg [0094]), and also that Moberg ([0005]) teaches this to be an optional feature in some embodiments, not an explicit requirement or design goal of the overall device of Moberg. Thus, this is also respectfully found unpersuasive.
Applicant additionally argues that it would not have been obvious to measure the travel distance of the plunger driver in Moberg as modified because the amounts of insulin injected would be so small that it would be difficult to measure accurately or at all. Examiner respectfully disagrees. One of ordinary skill in the art could choose a sensor with an appropriate sensitivity for the intended purpose and scale of movements of the plunger driver in the modified device.
Applicant further argues that these concerns vastly overweigh the benefit gained from the modification made in Moberg, and thus “a person skilled in the art would never consider the proposed modifications” (Applicant’s Remarks at pg. 8). Examiner respectfully disagrees. One of ordinary skill in the art could have made the modifications as indicated above such as to render the modified device usable and suitable for its intended purposes, and yield the benefit of the modifications in allowing for the device to be usable with different sizes of syringe.
Applicant further argues that the modifications made to Moberg go against Moberg’s stated goal of water resistance and allowing for the ability to participate in water sports. Examiner again notes that Moberg teaches these aspects can be achieved in certain embodiments, such as at [0005] (“of medication or other fluids over an extended period compared to manual syringe therapy. The infusion pump can be designed to be extremely compact as well as water resistant, and may be adapted to be carried by the user, for example, by means of a belt clip or a harness. As a result, precise amounts of medication may be automatically delivered to the user without significant restriction on the user's mobility or life-style, including in some cases the ability to participate in water sports.”). This does not constitute a teaching away from the modifications made in the modified device, and one of ordinary skill in the art could have made the modifications present in the modified device with a device which could have been used near water, especially since the modified device could have included the syringe being mounted stably such as to deliver precise amounts of medicine and could have included a seal around the motor and sensors therefor to allow for water sports use while still achieving the cited benefits for making the modifications.
Applicant finally argues that the new claim amendments overcome the previous rejection with regards to the newly claimed safety factor limitation. This argument is persuasive but has been rendered moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated above.
Conclusion
Fahrer (US 20100305506) is considered relevant prior art regarding use of input current to achieve a specific flow rate as measured by pressure and including the use of safety factors at [0039] and [0053].
Brundle (US Pat. No. 7338260) is considered relevant prior art regarding providing increasing or decreasing amounts of current to stepper motors in infusion devices as needed.
Cauley (US 20110097229) is considered relevant prior art regarding providing variable amounts of current to a motor for an infusion device dependent on sensor readings.
Maske (US Pat. No. 6208107) is considered relevant prior art regarding providing varying amounts of current to a stepper motor to achieve different amounts of audible noise.
Nyholm (US 20110264046) is considered relevant prior art regarding providing different amounts of current to a motor in an injection device.
Smith (US 20120078222) is considered relevant prior art regarding teaching the use of controlling torque and speed from a motor in an injection device similar to what is claimed.
Critchlow (US 20020016569) is considered relevant prior art regarding controlling a motor and power provided thereto and extracted therefrom based on outputs of sensors in an injection device.
Krulevitch (US Pat. No. 7654127) is considered relevant prior art regarding use of sensors to control motor outputs in a driving mechanism of an injection device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights