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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/7/2025 has been entered.
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.
Claim(s) 1, 4, 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 4525165) in view of Burke et al. (US 20100089487 hereinafter “Burke”) and Rogers et al. (US 20020087120 hereinafter “Rogers”).
Regarding Claim 1, Fischell teaches (Fig 3) an implantable drug delivery device (see Col 3 lines 32-34 teaching the invention is an implantable apparatus) comprising:
a pump (52);
a fluid reservoir (18) upstream of the pump (52; see Fig 3, 18 is upstream since the fluid flow is towards the right of the figure), the fluid reservoir comprising a medicament (Col 3 lines 61-62, "medication chamber 18 is filled with medication");
an accumulator (36) fluidly coupled to the pump (52) downstream of the pump (See Fig 3, accumulator 36 is downstream of pump 52), wherein the accumulator (36) comprises a bladder (See Col 4 lines 21-56 teaching that accumulator 36 has a variable volume chamber 40 with flexible walls 42, this is considered a ‘bladder’);
a conduit (58, 62, 41) fluidly connecting the pump (52), the accumulator (36);
Fischell does not specify the bladder enclosing a compressible fluid; a valve fluidly coupled to the accumulator downstream of the accumulator, the valve configured to transition between an open state and a closed state, and the conduit fluidly connecting the valve; wherein operating the pump with the valve continuously in the open state enables flow of the medicament from the fluid reservoir through the conduit, past the accumulator, and through the valve in the open state, providing a steady-state delivery of the medicament at a first velocity,
wherein operating the pump with the valve in the closed state enables flow of the medicament from the fluid reservoir to at least partially fill the accumulator by displacing the bladder and compressing the compressible fluid, and
wherein subsequently transitioning the valve from the closed state to the open state enables the at least partially filled accumulator to dispense medicament into the conduit and through the valve in the open state by expansion of the bladder under pressure of the compressible fluid, thereby delivering a bolus of the medicament at a second velocity, wherein the second velocity is greater than the first velocity.
Burke teaches an accumulator (Fig 4, 10) with a bladder (40) that encloses a compressible fluid (see [0027-0028] teaching how diaphragm 57 which includes bladder 40, encloses and moves due to pressurized gas). Burke also teaches a valve (Figs 1 and 6, 11) fluidly coupled to the accumulator (10) downstream of the accumulator (See Figs 1 and 6, 11 is downstream of 10); the valve (11) configured to transition between an open state (Fig 6, bottom example) and a closed state (Fig 6 top three examples), and the conduit fluidly connecting the valve (See Fig 1, a conduit fluidly connects the valve and accumulator);
wherein operating the pump with the valve in the closed state enables flow of the medicament from the fluid reservoir to at least partially fill the accumulator by displacing the bladder and compressing the compressible fluid (See Fig 6; also see [0028] “The second step in the cycle shows the accumulator 10 after an inlet valve 8 has been opened (maintaining the outlet valve 11 closed). The infusate fluid overcomes the bias of the pressurized gas against the diaphragm 40, and deflects the diaphragm 40 upward, thereby filling the diaphragm chamber 57 with fluid from the reservoir.”), and
wherein subsequently transitioning the valve from the closed state to the open state enables the at least partially filled accumulator to dispense medicament into the conduit and through the valve in the open state by expansion of the bladder under pressure of the compressible fluid, thereby delivering a bolus of the medicament (See Fig 6; also see [0028] “The final step in the cycle is the opening of the outlet valve 11 (while maintaining the inlet valves 8 and 9 in the closed position) to empty the diaphragm chamber 57 through the catheter 36, wherein the diaphragm 40 deflects downward as a result of the bias from the gas pressure in the gas chamber 52 and in the gas side of the diaphragm chamber 57.”).
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 device of Fischell such that it includes the bladder enclosing a compressible fluid; a valve fluidly coupled to the accumulator downstream of the accumulator, the valve configured to transition between an open state and a closed state, and the conduit fluidly connecting the valve;
wherein operating the pump with the valve in the closed state enables flow of the medicament from the fluid reservoir to at least partially fill the accumulator by displacing the bladder and compressing the compressible fluid, and wherein subsequently transitioning the valve from the closed state to the open state enables the at least partially filled accumulator to dispense medicament into the conduit and through the valve in the open state by expansion of the bladder under pressure of the compressible fluid, thereby delivering a bolus of the medicament as taught by Burke. One of ordinary skill in the art would have been motivated to do so in order to control the flow of fluid from the reservoir without requiring a constant pressure to initiate flow (see Burke [0029]).
The combination does not specify wherein operating the pump with the valve continuously in the open state enables flow of the medicament from the fluid reservoir through the conduit, past the accumulator, and through the valve in the open state, providing a steady-state delivery of the medicament at a first velocity, or that wherein subsequently transitioning the valve from the closed state to the open state enables the at least partially filled accumulator to dispense medicament into the conduit and through the valve in the open state by expansion of the bladder under pressure of the compressible fluid, thereby delivering a bolus of the medicament at a second velocity, wherein the second velocity is greater than the first velocity.
Rogers teaches (Fig 2) a valve (202) that is used to provides two different flow rates (See [0019] “These two states may correspond to an "open" and "closed" condition, or may correspond to two different flow rates”), wherein operating the pump with the valve continuously in the open state enables a steady-state delivery of medicament at a first velocity (see [0020], “In accordance with the invention, the duration of the open and closed states of valve 202 are chosen to achieve a desired average flow rate over a large time interval”), and delivering a bolus of medicament at a second velocity, wherein the second velocity is greater than the first velocity (see [0019], “Control module 250 is adapted to provides intermittent signals to change to state of valve 202 to achieve desired time-average flow rates”; The examiner interprets that the medicament having two different flow rates as having two different velocities based on the open and closed valve as flow rate is a function of velocity. While Rogers may not specify the higher velocity due to the expansion of the bladder, the examiner takes the position that with the combination described above, when the medicament in the accumulator is pressurized from the closed state of the valve, the flow rate—and therefore velocity—will be higher than normal when the valve opens as opposed to a non-pressurized accumulator).
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 valve of the modified Fischell such that wherein operating the pump with the valve continuously in the open state enables flow of the medicament from the fluid reservoir through the conduit, past the accumulator, and through the valve in the open state, providing a steady-state delivery of the medicament at a first velocity, or that wherein subsequently transitioning the valve from the closed state to the open state enables the at least partially filled accumulator to dispense medicament into the conduit and through the valve in the open state by expansion of the bladder under pressure of the compressible fluid, thereby delivering a bolus of the medicament at a second velocity, wherein the second velocity is greater than the first velocity as taught by Rogers. One of ordinary skill in the art would have been motivated to do so in order to have further control to achieve the desired flow rate of the medicament (See Rogers [0020]).
Regarding Claim 4, the combination of Fischell, Burke and Rogers teaches the implantable device of claim 1, wherein the accumulator defines a vessel separated into a first portion and a second portion by the bladder (See Burke Fig 4, bladder 40 divides the accumulator 10 into a vessel 57 comprising a first portion above 40 a second portion below 40).
Regarding Claim 22, Fischell teaches (Fig 3) an implantable drug delivery device (see Col 3 lines 32-34 teaching the invention is an implantable apparatus) comprising:
a fluid reservoir (18) comprising a medicament (Col 3 lines 61-62, "medication chamber 18 is filled with medication");
a pump (52) fluidly coupled to the fluid reservoir (18);
an accumulator (36) fluidly coupled to the pump (52) and comprising a vessel (40) with a bladder (See Col 4 lines 21-56 teaching that accumulator 36 has a variable volume chamber 40 with flexible walls 42, this is considered a ‘bladder.
Fischell does not specify a bladder dividing the vessel into a first portion and a second portion; a valve fluidly coupled to the accumulator, the valve configured to transition between an open state and a closed state,
wherein the valve cooperates with the pump to provide a first delivery profile comprising a steady-state delivery of the medicament through the valve,
wherein the valve cooperates with the accumulator to provide a second delivery profile comprising a bolus delivery of a bolus quantity of the medicament through the valve,
wherein the bolus delivery is provided by transitioning the valve into the closed state and operating the pump to fill the bolus quantity of the medicament into the second portion of the accumulator, and subsequently transitioning the valve into the open state to enable the accumulator to discharge the bolus quantity of the medicament through the valve by expansion of the bladder.
Burke teaches an accumulator (Fig 4, 10) with a vessel (57) and a bladder (40) separated into a first portion and a second portion by the bladder (See Burke Fig 4, bladder 40 divides the accumulator 10 into a vessel (57) comprising a first portion above 40 a second portion below 40). Burke also teaches a valve (Figs 1 and 6, 11) fluidly coupled to the accumulator (10); the valve (11) configured to transition between an open state (Fig 6, bottom example) and a closed state (Fig 6 top three examples);
wherein operating the pump with the valve in the closed state enables flow of the medicament from the fluid reservoir to at least partially fill the accumulator by displacing the bladder and compressing the compressible fluid (See Fig 6; also see [0028] “The second step in the cycle shows the accumulator 10 after an inlet valve 8 has been opened (maintaining the outlet valve 11 closed). The infusate fluid overcomes the bias of the pressurized gas against the diaphragm 40, and deflects the diaphragm 40 upward, thereby filling the diaphragm chamber 57 with fluid from the reservoir.”), and
wherein subsequently transitioning the valve from the closed state to the open state enables the at least partially filled accumulator to dispense medicament into the conduit and through the valve in the open state by expansion of the bladder under pressure of the compressible fluid, thereby delivering a bolus of the medicament (See Fig 6; also see [0028] “The final step in the cycle is the opening of the outlet valve 11 (while maintaining the inlet valves 8 and 9 in the closed position) to empty the diaphragm chamber 57 through the catheter 36, wherein the diaphragm 40 deflects downward as a result of the bias from the gas pressure in the gas chamber 52 and in the gas side of the diaphragm chamber 57.”).
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 device of Fischell such that it includes the bladder dividing the vessel into a first portion and a second portion; a valve fluidly coupled to the accumulator, the valve configured to transition between an open state and a closed state,
wherein the valve cooperates with the accumulator to provide a second delivery profile comprising a bolus delivery of a bolus quantity of the medicament through the valve,
wherein the bolus delivery is provided by transitioning the valve into the closed state and operating the pump to fill the bolus quantity of the medicament into the second portion of the accumulator, and subsequently transitioning the valve into the open state to enable the accumulator to discharge the bolus quantity of the medicament through the valve by expansion of the bladder as taught by Burke. One of ordinary skill in the art would have been motivated to do so in order to control the flow of fluid from the reservoir without requiring a constant pressure to initiate flow (see Burke [0029]).
The combination does not specify wherein the valve cooperates with the pump to provide a first delivery profile comprising a steady-state delivery of the medicament through the valve.
Rogers teaches (Fig 2) a valve (202) that is used to provides two different flow rates (See [0019] “These two states may correspond to an "open" and "closed" condition, or may correspond to two different flow rates”), wherein operating the pump with the valve continuously in the open state enables a steady-state delivery of medicament (see [0020], “In accordance with the invention, the duration of the open and closed states of valve 202 are chosen to achieve a desired average flow rate over a large time interval”).
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 valve of the modified Fischell such that the valve cooperates with the pump to provide a first delivery profile comprising a steady-state delivery of the medicament through the valve as taught by Rogers. One of ordinary skill in the art would have been motivated to do so in order to have further control to achieve the desired flow rate of the medicament (See Rogers [0020]).
Regarding Claim 23, the combination of Fischell, Burke and Rogers teaches the implantable device of claim 22, wherein the steady state delivery provides the medicament at a first velocity and the bolus delivery provides the medicament at a second velocity higher than the first velocity (See Rogers [0019] “Control module 250 is adapted to provides intermittent signals to change to state of valve 202 to achieve desired time-average flow rates”; The examiner interprets that the medicament having two different flow rates as having two different velocities based on the open and closed valve as flow rate is a function of velocity. While Rogers may not specify the higher velocity due to the expansion of the bladder, the examiner takes the position that with the combination described above, when the medicament in the accumulator is pressurized from the closed state of the valve, the flow rate—and therefore velocity—will be higher than normal when the valve opens as opposed to a non-pressurized accumulator).
Regarding Claim 24, the combination of Fischell, Burke and Rogers teaches the implantable device of claim 22, wherein the accumulator comprises a compressible fluid in the first portion (See Burke Fig 4 and [0027-0028], teaching accumulator 10 has pressurized gas – a compressible fluid).
Claim(s) 2, is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Burke and Rogers as applied to claim 1 above, and further in view of Bodner (US 20220184298, note this reference was previously cited).
Regarding Claim 2, the combination of Fischell, Burke and Rogers teaches all elements of claim 1 as described above. The combination does not specify a peristaltic pump.
Bodner teaches an implantable pump wherein the pump is a peristaltic pump ([0036], “The pump 118 can be any pump sufficient for infusing to the patient, such as a peristaltic pump”).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to substitute the pump of the modified Fischell with the peristaltic pump of Bodner. One of ordinary skill in the art would have been motivated to do so since a peristaltic pump specifically would increase precision and prevention of fluids from being contaminated by exposed pump components since its contained in a flexible tube. Furthermore, Bodner teaches that the pump can be any pump sufficient for infusing to the patient (Bodner [0036]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell, Burke and Rogers as applied to claim 1, and further in view of Grant et al. (US 20150165114 hereinafter “Grant”, note this reference was previously cited).
Regarding Claim 3, the combination of Fischell, Burke and Rogers teaches all elements of claim 1 as described above. The combination does not specify the steady-state delivery comprises a rate between about 0 uL/hr and about 1 uL/hr.
Grant teaches a fluid delivery system that teaches a peristaltic ([1078]) infusion pump assembly (Abstract , “An infusion pump system”) that is configured to pump medicament at a rate of between about 0 uL/hr ([0496] “The user may then use slider assembly 306 to highlight "Bolus: 0.0 Units" within submenu 354, which may be selected using switch assembly 308”) and about 1uL/hr ([1025], “the basal infusion rates may be pre-programmed and may include specified rates for pre-programmed time- frames, e.g., a rate of 0.50 units per hour”). One (1) unit of insulin is equivalent to0.01 mL or 10 microliters. Consequently, 0.05 units is equivalent to 0.0005mL or 0.5 microliters .
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to modify Fischell with Grant such that the steady-state delivery isa rate in a range between about 0 uL/hr and about 1 uL /hr since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. ( In re Aller, 105 USPQ 233.)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Bure and Rogers as applied to claim 1 above, and further in view of Flaherty (US 20040204673 note this reference was previously cited).
Regarding Claim 5, the combination of Fischell, Burke and Rogers teaches all elements of claim 1 as described above. The combination does not specify the accumulator that is configured to store at least about 0.25 uL of medicament.
Flaherty teaches an infusion device with an accumulator that is configured to temporally store at least about 0.25 uL of medicament ([0081]“A specific pulse volume "PV" of fluid is defined by the volume displaced when the accumulator membrane moves from its fully expanded to equilibrium conditions...a pulse volume of between 0.1 microliter and 5 microliters is acceptable”).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to modify the accumulator of Fischell to configure it to store at least about 0.25uL of medicament as taught by Flaherty. One of ordinary skill in the art would have been motivated to do so in order to allow the reservoir to carry higher concentrations of liquid medication and reduce the overall size of the reservoir ( Flaherty [0081]).
Claim(s) 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable Fischell in view of Burke and Rogers as applied to claim 1 above, and further in view of Benkowski et al. (US 20050131271 hereinafter “Benkowski” note this reference was previously cited).
Regarding Claim 6, the combination of Fischell, Burke and Rogers teaches all elements of claim 1 as described above. The combination does not specify a computing device configured to sense an electromotive force voltage of the pump.
Benkowski teaches an implantable pump (12; see [0020]) having a stator (40) and a rotor (42), wherein the pump operates in a series of pulses to expel fluid (see [0029] teaching the pump speed (pulses) adjusted for desired flow rate); a computing device (84) configured to sense an electromotive force voltage of the pump (See [0026] "the motor controller 84 senses back electromotive force (EMF) voltage").
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 implantable pump of Fischell with a computing device configured to sense an electromotive force voltage of the pump as taught by Benkowski. One of ordinary skill in the art would have been motivated to do so in order to ensure proper commutation within the pump (Benkowski [0026]).
Regarding Claim 12, the combination of Fischell, Burke, Rogers and Benkowski teaches the implantable pump of claim 6, further comprising a computing device (Benkowski 84) configured to sense the oscillations in the electromotive force voltage of the pump (See Benkowski [0026] "the motor controller 84 senses back electromotive force (EMF) voltage").
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable Fischell in view of Burke and Rogers as applied to claim 1 above, and further in view of Peterson et al (US 6241704 hereinafter “Peterson”, note this reference was previously cited).
Regarding Claim 7, the combination of Fischell, Burke and Rogers teaches all elements of claim 1 as described above. The combination does not specify a pressure sensor configured to sense a pressure of medicament downstream of the pump.
Peterson teaches a drug pump system further comprising a pressure sensor configured to sense a pressure of medicament downstream of the pump (Col 6, first paragraph, “Preferably, at least a downstream occlusion sensor 186b, such as a pressure or force sensitive sensor for sensing pressure in tubing 110 is provided, along with an associated CPU or hardwired circuitry”).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to combine the implantable pump of Fischell with a pressure sensor configured to sense a pressure of medicament downstream of the pump as taught by Peterson. One of ordinary skill in the art would have been motivated to do so in order to identify malfunctions and prevent the pump from running unless the pressure sensed is appropriate (Peterson Col 38, lines 37-56).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Burke, Rogers and Benkowski as applied to claim 12 above, and further in view of Peterson (US 6241704).
Regarding Claim 13, the combination of Fischell, Burke, Rogers and Benkowski teaches all elements of claim 12 as described above. The combination does not specify a pressure sensor configured to sense a pressure of medicament downstream of the pump, wherein the pressure sensor activates upon detection of damped oscillations from the sensed electromotive force voltage.
Peterson teaches a drug pump system further comprising a pressure sensor configured to sense a pressure of medicament downstream of the pump (Col 6, first paragraph, “Preferably, at least a downstream occlusion sensor 186b, such as a pressure or force sensitive sensor for sensing pressure in tubing 110 is provided, along with an associated CPU or hardwired circuitry”), wherein the pressure sensor activates upon detection of damped oscillations from the sensed electromotive force voltage (Col 45 lines 10-13 “Pump 100 is set to stop pumping due to an occlusion in tube when the pressure of pump 100 reaches a predetermined level due to the activation of occlusion detector 186 at a predetermined pressure sensed by occlusion detector 186”).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to combine the implantable pump of Fischell with a pressure sensor configured to sense a pressure of medicament downstream of the pump wherein the pressure sensor activates upon detection of damped oscillations from the sensed electromotive force voltage as taught by Peterson. One of ordinary skill in the art would have been motivated to do so in order to identify malfunctions and prevent the pump from running unless the pressure sensed is appropriate (Peterson Col 38, lines 37-56).
Claim(s) 14, 17-18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 4525165) in view of Burke et al. (US 20100089487 hereinafter “Burke”), Rogers et al. (US 20020087120 hereinafter “Rogers”), Benkowski et al. (US 20050131271 hereinafter “Benkowski”) and Bodner (US 20220184298).
Regarding Claim 14, Fischell teaches (Fig 3) an implantable drug delivery device (See Col 3 lines 32-34 teaching the invention is an implantable apparatus) with occlusion detection, comprising:
a fluid reservoir (18) comprising a medicament (Col 3 lines 61-62, "medication chamber 18 is filled with medication");
a pump (52) fluidly coupled to the fluid reservoir (18);
an accumulator (36) fluidly coupled to the pump (52) and comprising a vessel (40) with a bladder (42).
Fischell does not specify a bladder dividing the vessel into a first portion and a second portion; a valve fluidly coupled to the accumulator, the valve configured to transition between an open state and a closed state,
wherein the valve cooperates with the pump to provide a first delivery profile comprising a steady-state delivery of the medicament through the valve,
wherein the valve cooperates with the accumulator to provide a second delivery profile comprising a bolus delivery of a bolus quantity of the medicament through the valve,
wherein the bolus delivery is provided by transitioning the valve into the closed state and operating the pump to fill the bolus quantity of the medicament into the second portion of the accumulator, and subsequently transitioning the valve into the open state to enable the accumulator to discharge the bolus quantity of the medicament through the valve by expansion of the bladder.
Burke teaches an accumulator (Fig 4, 10) with a vessel (57) and a bladder (40) separated into a first portion and a second portion by the bladder (See Burke Fig 4, bladder 40 divides the accumulator 10 into a vessel (57) comprising a first portion above 40 a second portion below 40). Burke also teaches a valve (Figs 1 and 6, 11) fluidly coupled to the accumulator (10); the valve (11) configured to transition between an open state (Fig 6, bottom example) and a closed state (Fig 6 top three examples);
wherein operating the pump with the valve in the closed state enables flow of the medicament from the fluid reservoir to at least partially fill the accumulator by displacing the bladder and compressing the compressible fluid (See Fig 6; also see [0028] “The second step in the cycle shows the accumulator 10 after an inlet valve 8 has been opened (maintaining the outlet valve 11 closed). The infusate fluid overcomes the bias of the pressurized gas against the diaphragm 40, and deflects the diaphragm 40 upward, thereby filling the diaphragm chamber 57 with fluid from the reservoir.”), and
wherein subsequently transitioning the valve from the closed state to the open state enables the at least partially filled accumulator to dispense medicament into the conduit and through the valve in the open state by expansion of the bladder under pressure of the compressible fluid, thereby delivering a bolus of the medicament (See Fig 6; also see [0028] “The final step in the cycle is the opening of the outlet valve 11 (while maintaining the inlet valves 8 and 9 in the closed position) to empty the diaphragm chamber 57 through the catheter 36, wherein the diaphragm 40 deflects downward as a result of the bias from the gas pressure in the gas chamber 52 and in the gas side of the diaphragm chamber 57.”).
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 device of Fischell such that it includes the bladder dividing the vessel into a first portion and a second portion; a valve fluidly coupled to the accumulator, the valve configured to transition between an open state and a closed state,
wherein the valve cooperates with the accumulator to provide a second delivery profile comprising a bolus delivery of a bolus quantity of the medicament through the valve,
wherein the bolus delivery is provided by transitioning the valve into the closed state and operating the pump to fill the bolus quantity of the medicament into the second portion of the accumulator, and subsequently transitioning the valve into the open state to enable the accumulator to discharge the bolus quantity of the medicament through the valve by expansion of the bladder as taught by Burke. One of ordinary skill in the art would have been motivated to do so in order to control the flow of fluid from the reservoir without requiring a constant pressure to initiate flow (see Burke [0029]).
The combination does not specify wherein the valve cooperates with the pump to provide a first delivery profile comprising a steady-state delivery of the medicament through the valve.
Rogers teaches (Fig 2) a valve (202) that is used to provides two different flow rates (See [0019] “These two states may correspond to an "open" and "closed" condition, or may correspond to two different flow rates”), wherein operating the pump with the valve continuously in the open state enables a steady-state delivery of medicament (see [0020], “In accordance with the invention, the duration of the open and closed states of valve 202 are chosen to achieve a desired average flow rate over a large time interval”).
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 valve of the modified Fischell such that the valve cooperates with the pump to provide a first delivery profile comprising a steady-state delivery of the medicament through the valve as taught by Rogers. One of ordinary skill in the art would have been motivated to do so in order to have further control to achieve the desired flow rate of the medicament (See Rogers [0020]).
The combination does not specify a computing device configured sense an electromotive force voltage and detect oscillations in the electromotive force voltage; wherein the computing device monitors the detected oscillations in the electromotive force voltage during discharge of the accumulator to infer a medicament pressure decay inside the device following opening of the valve.
Benkowski teaches an implantable pump (12; see [0020]) having a stator (40) and a rotor (42), a computing device (84)configured sense an electromotive force voltage (See [0026] "the motor controller 84 senses back electromotive force (EMF) voltage from the motor windings 52"); wherein the computing device senses the electromotive force voltage during discharge of the accumulator to infer a medicament pressure decay inside the accumulator following opening of the valve (See [0026] teaching the detection of EMF voltage and see [0045] also teaching pressure is monitored with the change in flow rate).
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 implantable pump of Fischell with a computing device configured sense an electromotive force voltage and detect oscillations in the electromotive force voltage; wherein the computing device monitors the detected oscillations in the electromotive force voltage during discharge of the accumulator to infer a medicament pressure decay inside the device following opening of the valve as taught by Benkowski. One of ordinary skill in the art would have been motivated to do so, a this is an alternative well known pump and would ensure proper commutation (Benkowski [0026]).
The combination does not specify a peristaltic pump.
Bodner teaches an implantable pump wherein the pump is a peristaltic pump ([0036], “The pump 118 can be any pump sufficient for infusing to the patient, such as a peristaltic pump”).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to substitute the pump of the modified Fischell with the peristaltic pump of Bodner. One of ordinary skill in the art would have been motivated to do so since a peristaltic pump specifically would increase precision and prevention of fluids from being contaminated by exposed pump components since its contained in a flexible tube. Furthermore, Bodner teaches that the pump can be any pump sufficient for infusing to the patient (Bodner [0036]).
Regarding Claim 17, the combination of Fischell, Burke, Rogers, Benkowski and Bodner teaches the implantable pump of claim 14, wherein the computing device (Benkowski 84) configured to sense oscillations in the electromotive force voltage (See Benkowski [0026] "the motor controller 84 senses back electromotive force (EMF) voltage").
Regarding Claim 18, the combination of Fischell, Burke, Rogers, Benkowski and Bodner teaches all elements of claim 17 as described above. The combination does not specify wherein the computing device configured to determine if the oscillations are damped in reference to a model electromotive force voltage curve.
Bodner teaches a computing device configured to determine if the oscillations are damped in reference to a model electromotive force voltage (see [0038], “The computing device 120 can generally be configured to control infusion of infusate according to programmed parameters or a specified treatment protocol”). Examiner is interpreting the ‘programmed parameters or a specified treatment protocol’ to include a model electromotive force voltage curve as a reference as the computing device is in further electrical communication with the peristaltic pump and could be used to detect if the oscillations are damped ([0036]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to further modify Fischell to include a computing device configured to determine if the oscillations are damped in reference toa model electromotive force voltage as taught by Bodner. One of ordinary skill in the art would have been motivated to do so in order to have feedback of the infusion to further ensure that the implantable pump is working properly and administering the proper dosage of medicament.
Regarding Claim 21, the combination of Fischell, Burke, Rogers, Benkowski and Bodner teaches the implantable device of claim 14, wherein the steady state delivery provides the medicament at a first velocity and the bolus delivery provides the medicament at a second velocity higher than the first velocity (See Rogers [0019] “Control module 250 is adapted to provides intermittent signals to change to state of valve 202 to achieve desired time-average flow rates”; The examiner interprets that the medicament having two different flow rates as having two different velocities based on the open and closed valve as flow rate is a function of velocity. While Rogers may not specify the higher velocity due to the expansion of the bladder, the examiner takes the position that with the combination described above, when the medicament in the accumulator is pressurized from the closed state of the valve, the flow rate—and therefore velocity—will be higher than normal when the valve opens as opposed to a non-pressurized accumulator).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell, Burke, Rogers, Benkowski and Bodner as applied to claims 14 above, and further in view of Grant et al. (US 20150165114 hereinafter “Grant”, note this reference was previously cited).
Regarding Claim 15, the combination of Fischell, Burke, Rogers, Benkowski and Bodner teaches the claimed invention of claim 14 and further teaches that the pump is configured to pump medicament at a steady state rate (Rogers [0020] teaches, “control module 250 provides signals to periodically change the state of valve 202 to achieve a desired flow rate”). The combination does not expressly disclose a pump configured to pump medicament at a rate between about 0 uL/hr and about 1 uL/hr.
Grant teaches a fluid delivery system that teaches a peristaltic ([1078]) infusion pump assembly (Abstract , “An infusion pump system”) that is configured to pump medicament at a rate of between about 0 uL/hr ([0496] “The user may then use slider assembly 306 to highlight "Bolus: 0.0 Units" within submenu 354, which may be selected using switch assembly 308”) and about 1uL/hr ([1025], “the basal infusion rates may be pre-programmed and may include specified rates for pre-programmed time- frames, e.g., a rate of 0.50 units per hour”). One (1) unit of insulin is equivalent to0.01 mL or 10 microliters. Consequently, 0.05 units is equivalent to 0.0005mL or 0.5 microliters .
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to modify Fischell with Grant such that the pump is configured to pump medicament at a range between about 0 uL/hr and about 1 uL /hr since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. ( In re Aller, 105 USPQ 233.)
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell, Burke, Rogers, Benkowski and Bodner as applied to claims 14 above, and further in view of Flaherty (US 20040204673 note this reference was previously cited).
Regarding Claim 16, the combination of Fischell, Burke, Rogers, Benkowski and Bodner teaches all elements of claim 14 as described above. The combination does not specify the accumulator that is configured to be charged with a bolus of at least about 0.25 uL of medicament.
Flaherty teaches an infusion device with an accumulator that is configured to store at least about 0.25 uL of medicament ([0081]“A specific pulse volume "PV" of fluid is defined by the volume displaced when the accumulator membrane moves from its fully expanded to equilibrium conditions...a pulse volume of between 0.1 microliter and 5 microliters is acceptable”).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to modify the accumulator of Fischell to configure it to be charged with a bolus of at least about 0.25 uL of medicament as taught by Flaherty. One of ordinary skill in the art would have been motivated to do so in order to allow the reservoir to carry higher concentrations of liquid medication and reduce the overall size of the reservoir (Flaherty [0081]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable Fischell, Burke, Rogers, Benkowski and Bodner as applied to claims 14 above, and further in view of Peterson et al (US 6241704 hereinafter “Peterson”, note this reference was previously cited).
Regarding Claim 19-20, the combination of Fischell, Burke, Rogers, Benkowski and Bodner teaches all elements of claim 14 as described above. The combination does not specify a pressure sensor configured to sense a pressure of medicament downstream of the pump, wherein the pressure sensor activates upon detection of damped oscillations from the sensed electromotive force voltage.
Peterson teaches a drug pump system further comprising a pressure sensor configured to sense a pressure of medicament downstream of the pump (Col 6, first paragraph, “Preferably, at least a downstream occlusion sensor 186b, such as a pressure or force sensitive sensor for sensing pressure in tubing 110 is provided, along with an associated CPU or hardwired circuitry”), wherein the pressure sensor activates upon detection of damped oscillations from the sensed electromotive force voltage (Col 45 lines 10-13 “Pump 100 is set to stop pumping due to an occlusion in tube when the pressure of pump 100 reaches a predetermined level due to the activation of occlusion detector 186 at a predetermined pressure sensed by occlusion detector 186”).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to combine the implantable pump of Fischell with a pressure sensor configured to sense a pressure of medicament downstream of the pump wherein the pressure sensor activates upon detection of damped oscillations from the sensed electromotive force voltage as taught by Peterson. One of ordinary skill in the art would have been motivated to do so in order to identify malfunctions and prevent the pump from running unless the pressure sensed is appropriate (Peterson Col 38, lines 37-56).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 14 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 9/8/2025.
Conclusion
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783