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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 11, 2026 has been entered.
Claims 1-11 and 13-20 remain pending in the application. Claim 12 was previously cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey (US 20020029018) in view of Kirk et al. (US 20130331771).
Regarding claim 1, Jeffrey discloses an on-body drug delivery system (user-wearable device 10 having dispensing device 100), comprising:
an adhesive layer configured to adhere the on-body drug delivery system to skin of a patient (“The dispensing device 100 is shown in FIGS. 3A-D as enclosed within a flattish multi-compartment carrier 10 alongside a battery 170 and control electronics 180…the whole may be worn by the user, say strapped in place and/or secured by adhesive.” [0037]);
a reservoir (pre-loaded cartridge 120) configured to contain a liquid drug (drug contents 126; Figure 3A);
a plunger (piston 125) configured to seal an end of the reservoir (Figure1A; “The hub 117 is in an all-round reduced throat part 121 of the cartridge 120 from its main drugs etc dose-containing part 122 that is sealed off by a piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]);
a rack (piston-rod 140) having a plurality of teeth (“The piston-rod 140 has a lengthwise row or rack of ratchet-tooth 143” [0033]) and coupled to the plunger (“A preferred piston-rod is shown in FIGS. 2C, D as being of two-part form of which…part 140B engages the cartridge piston 125” [0034]), wherein the rack is configured to move the plunger within the reservoir (“Movement of the piston 125 is driven by piston-rod 140” [0034]; Figures 1A-1C);
an arm (pawl-carrier 150) having a pawl (pawl 153) configured to engage the rack (“The piston-rod 140 has a lengthwise row or rack of ratchet-tooth 143 to cooperate with pawl 153 on arm 154 extending from end-flanging 155 of the pawl carrier 150.” [0033]), wherein an end of the pawl is configured to disengage itself from a tooth of the plurality of teeth while the rack remains stationary (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means.” [0006]; “The piston-rod 150 is correspondingly moved and latched at 158/9. The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein the pawl is deflected away/disengaged from the tooth on the return stroke and the rod 140 remains stationary due to latch 159), wherein the rack remains stationary after an end of the pawl is disengaged from the tooth (“Another abutment 158 within the holder body serves to control one-way flexing of a latching member 159 for the ratchet- teeth 143.” [0035], wherein the rod 140 remains stationary due to latching member 159); and
a power source (solenoid 110 powered by battery 170 and return spring 156) configured to extend and retract the arm (“The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 [140] is correspondingly moved and latched at 158/9.” [0036]), wherein extending the arm causes the plunger to expel an amount of the liquid drug (“piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]; “Movement of the piston 125 is driven by piston-rod 140” [0033]; “At least the preferred two-part piston-rod 140A, B of FIGS. 2C, D allows positive tolerance on ratchet action up to almost a second tooth pitch of movement without affecting accuracy of movement of the cartridge piston 125 by precisely one tooth pitch for each energisation of the solenoid 110” [0036]; Figures 1A-1B) and retracting the arm causes the pawl to move relative to the rack while the rack remains stationary (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; “The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward, the pawl 153 deflects away/moves relative to the stationary ratchet teeth 143 of the rack).
Jeffrey fails to explicitly disclose wherein an end of the pawl is configured to rotate relative to the arm while the rack remains stationary to disengage itself from a tooth of the plurality of teeth of the rack.
Kirk teaches a drug delivery system (fluid dispensing device 20) comprising: a reservoir (fluid chambers 24, 26); a plunger (plungers 36, 38); a rack (actuating member 92) having a plurality of teeth (teeth 112) and coupled to the plunger (“The actuating member 92 further includes an upright portion 98 that extends substantially orthogonally upward from the base portion 94 and is configured to engage the plunger heads 44, 46 of the plungers 36, 38 and actuate the plungers 36, 38 to dispense the fluid to the spray nozzle tip 50.” [0027]), wherein the rack is configured to move the plunger within the reservoir (“This ratcheting movement of the actuating member 92 causes the upright portion 98 of the actuating member 92 to actuate the plungers 36, 38...As the plungers 36, 38 move inwardly, the fluid is compressed within each of the respective fluid chambers 24, 26 and a volume of the fluid that is proportional to the linear displacement of the plungers 36, 38 is dispensed from the tapered distal ends into the spray nozzle tip 50.” [0031]); an arm (trigger 86) having a pawl (pawl 108) configured to engage the rack (Figures 3A-3B), wherein an end of the pawl (portion of pawl 108 engaged with teeth 112) is configured rotate relative to the arm while the rack (actuating member 92) remails stationary to disengage itself from a tooth of the plurality of teeth of the rack, wherein the rack remains stationary after an end of the pawl is disengaged from the tooth (“A release arm 114, which is coupled with the pawl 108, is accessible to the surgeon such that rearward biasing of the release arm 114 (i.e., toward the trigger 86), with or without a trigger pull, rotates the pawl 108 against the bias of the second torsion spring 110 and rotates the pawl 108 about the pawl pin 106 to withdraw the pawl 108 from the linear array of teeth 112 (FIG. 3C). Accordingly, the actuating member 92 may be retracted rearwardly and the fluid dispensing device 22 with holder 60 removed.” [0033]; Figure 3C shows the pawl 108 rotated relative to the trigger 86 to release from the actuating member 92. The actuating member 92 is stationary while this disengagement is occurring, and is then capable of being retracted after the release arm 114 has been rotated away from the teeth 112 but does not necessarily move backward); and wherein extending the arm causes the plunger to expel an amount of the liquid drug and retracting the arm causes the pawl to move relative to the rack while the rack remains stationary (see all of [0030-0031]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pawl of the on-body drug delivery system of Jeffrey to include that an end of the pawl is configured to rotate relative to the arm while the rack remains stationary to disengage itself from a tooth of the plurality of teeth of the rack based on the teachings of Kirk to allow the rack of the drug delivery system to be reset to the original, rearward starting position, such as to refill the reservoir (Kirk [0033]).
Regarding claim 2, modified Jeffrey teaches the system of claim 1, wherein the arm (pawl-carrier 150) is sized such that extension of the arm is in a direction parallel to movement of the rack (“The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 [140] is correspondingly moved and latched at 158/9.” [0036]; Figures 1A-1B) and an amount of extension of the arm corresponds to the amount of the liquid drug expelled (“At least the preferred two-part piston-rod 140A, B of FIGS. 2C, D allows positive tolerance on ratchet action up to almost a second tooth pitch of movement without affecting accuracy of movement of the cartridge piston 125 by precisely one tooth pitch for each energisation of the solenoid 110.” [0036]; “piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]).
Regarding claim 3, modified Jeffrey teaches the system of claim 1, wherein the arm (pawl-carrier 150) has a length (Figure 1A) enabling the amount of the liquid drug expelled by the plunger to be a desired amount of the liquid drug when a corresponding amount of the length of the arm is extended (“The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 [140] is correspondingly moved and latched at 158/9…At least the preferred two-part piston-rod 140A, B of FIGS. 2C, D allows positive tolerance on ratchet action up to almost a second tooth pitch of movement without affecting accuracy of movement of the cartridge piston 125 by precisely one tooth pitch for each energisation of the solenoid 110.” [0036]; “piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]).
Regarding claim 4, modified Jeffrey teaches the system of claim 1, wherein the power source is operable to move the arm backward in a direction away from the plunger (“The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143…The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036]).
Regarding claim 5, modified Jeffrey teaches the system of claim 1, wherein the end of the pawl is configured to: disengage the rack when the arm is moved backward (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; “The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward, the pawl 153 deflects away/disengages from the ratchet teeth 143).
Modified Jeffrey fails to explicitly teach the end of the pawl is configured to disengage the rack prior to when the arm is moved backward.
Kirk teaches a drug delivery system (fluid dispensing device 20) comprising: a rack (actuating member 92) having a plurality of teeth (teeth 112); an arm (trigger 86) having a pawl (pawl 108); and wherein the end of the pawl end (portion of pawl 108 engaged with teeth 112) is configured to disengage the rack prior to when the arm is moved backward (“A release arm 114, which is coupled with the pawl 108, is accessible to the surgeon such that rearward biasing of the release arm 114 (i.e., toward the trigger 86), with or without a trigger pull, rotates the pawl 108 against the bias of the second torsion spring 110 and rotates the pawl 108 about the pawl pin 106 to withdraw the pawl 108 from the linear array of teeth 112 (FIG. 3C).” [0033]; Figure 3C showing the pawl 108 disengages teeth 112 prior to the trigger 86 moving back to its first, retracted position).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the on-body drug delivery system of Jeffrey to include the end of the pawl is configured to disengage the rack prior to when the arm is moved backward based on the teachings of Kirk to allow the rack of the drug delivery system to be reset to the original, rearward starting position, such as when the reservoir is refilled (Kirk [0033]).
Regarding claim 6, modified Jeffrey teaches the system of claim 1, wherein the end of the pawl is configured to: rotate away and disengage from when the rack (piston-rod 140) when the arm (pawl-carrier 150) is moved (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; “The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward, the pawl 153 rotates away from the ratchet teeth 143 as it deflects away).
Modified Jeffrey fails to explicitly disclose wherein the pawl is configured to rotate away and disengage from the rack prior to when the arm is moved.
Kirk teaches a drug delivery system (fluid dispensing device 20) comprising: a rack (actuating member 92) having a plurality of teeth (teeth 112); an arm (trigger 86) having a pawl (pawl 108); and wherein the end of the pawl end (portion of pawl 108 engaged with teeth 112) is configured to rotate away and disengage from the rack prior to when the arm is moved (“A release arm 114, which is coupled with the pawl 108, is accessible to the surgeon such that rearward biasing of the release arm 114 (i.e., toward the trigger 86), with or without a trigger pull, rotates the pawl 108 against the bias of the second torsion spring 110 and rotates the pawl 108 about the pawl pin 106 to withdraw the pawl 108 from the linear array of teeth 112 (FIG. 3C).” [0033]; Figure 3C showing the pawl 108 disengages teeth 112 prior to the trigger 86 moving back to its first, retracted position).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the on-body drug delivery system of Jeffrey to include the end of the pawl is configured to rotate away and disengage from the rack prior to when the arm is moved based on the teachings of Kirk to allow the rack of the drug delivery system to be reset to the original, rearward starting position, such as when the reservoir is refilled (Kirk [0033]).
Regarding claim 7, modified Jeffrey teaches the system of claim 1, wherein the plunger (piston 125) is configured to expel a portion of a liquid drug (drug contents 126) stored in the reservoir when moved in a linear direction (“piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]; “The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 [140] is correspondingly moved and latched at 158/9…At least the preferred two-part piston-rod 140A, B of FIGS. 2C, D allows positive tolerance on ratchet action up to almost a second tooth pitch of movement without affecting accuracy of movement of the cartridge piston 125 by precisely one tooth pitch for each energisation of the solenoid 110.” [0036]).
Regarding claim 8, modified Jeffrey teaches the system of claim 1, further comprising: a controller (control electronics 180) coupled to the power source (solenoid 110 powered by battery 170), wherein the controller is operable to control the power source (“Energisation pulses to the solenoid 110 come from a clock source 182, which may be a standard clock/watch quartz crystal chip, through dose-interval selection circuitry 183 set according to requirements of successive dosing of a patient” [0038]).
Regarding claim 9, modified Jeffrey teaches the system of claim 8, wherein the controller is further operable to: track movement of the arm; and maintain a count of a number of times the arm is moved to expel the liquid drug (“In operation, a counter 181 serves to count the number of incremental movements of the cartridge piston 125 corresponding to successful operations of the solenoid 110. Energisation pulses to the solenoid 110 come from a clock source 182, which may be a standard clock/watch quartz crystal chip, through dose-interval selection circuitry 183 set according to requirements of successive dosing of a patient, feasibly intendedly settable differently for each particular patient.” [0038]).
Regarding claim 10, Jeffrey discloses a method for expelling a liquid drug from an on-body drug delivery system (user-wearable device 10; “piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]), comprising:
extending by a power source (solenoid 110 powered by battery 170 and return spring 156) an arm (pawl-carrier 150) coupled to a pawl (pawl 153) that is engaged with a rack (piston-rod 140 having ratchet-teeth 143) in a first direction (“The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 [140] is correspondingly moved and latched at 158/9.” [0036]), wherein the arm is driven by the power source in response to a control signal from a controller (control electronics 180) from an initial position (Figures 1A-1B) to a final position (“Energisation pulses to the solenoid 110 come from a clock source 182, which may be a standard clock/watch quartz crystal chip, through dose-interval selection circuitry 183 set according to requirements of successive dosing of a patient” [0038]; wherein the final position in when the pawl is driven by one pitch: “drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 is correspondingly moved and latched at 158/9.” [0036]);
in response to extending the arm, expelling a dose of the liquid drug from a drug container (pre-loaded cartridge 120) of the on-body drug delivery system by a plunger (piston 125) coupled to the rack (“A preferred piston-rod is shown in FIGS. 2C, D as being of two-part form of which…part 140B engages the cartridge piston 125” [0034]; “piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]; “Movement of the piston 125 is driven by piston-rod 140” [0033]; “At least the preferred two-part piston-rod 140A, B of FIGS. 2C, D allows positive tolerance on ratchet action up to almost a second tooth pitch of movement without affecting accuracy of movement of the cartridge piston 125 by precisely one tooth pitch for each energisation of the solenoid 110” [0036]; Figures 1A-1B);
disengaging an end of the pawl from a tooth of the plurality of teeth of the rack while the rack remains stationary (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means.” [0006]; “The piston-rod 150 is correspondingly moved and latched at 158/9. The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein the pawl is deflected away/disengaged from the tooth on the return stroke and the rod 140 remains stationary due to latch 159), wherein the rack remains stationary after an end of the pawl is disengaged from the tooth (“Another abutment 158 within the holder body serves to control one-way flexing of a latching member 159 for the ratchet- teeth 143.” [0035], wherein the rod 140 remains stationary due to latching member 159);
retracting the arm by the power source in a second direction, opposite the first direction (“The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward under the force of the spring 156, the pawl 153 deflects away/avoids the ratchet teeth 143);
in response to retracting the arm in the second direction, moving the pawl relative to the rack while the rack remains stationary (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; “The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward, the pawl 153 deflects away/moves relative to the stationary ratchet teeth 143); and
stopping retracting of the arm in the second direction upon return to the initial position (Figures 1A-1B) in preparation for expelling a following dose of the liquid drug (“The flanging 155 of the pawl carrier 150 is also shown acted upon by a return spring 156 acting from an abutment ring 157 of or suitably fixed in the holder body 101.” [0035]; “The piston-rod 150 is correspondingly moved and latched at 158/9. The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036]; Figures 1A-1B showing the pawl-carrier 150 with its flanging 155 have retracted back to their initial position).
Jeffrey fails to explicitly teach rotating an end of the pawl relative to the arm while the rack remains stationary to disengage the end of the pawl from at least a tooth of a plurality of teeth of the rack.
Kirk teaches method for expelling a liquid drug from an drug delivery system (fluid dispensing device 22; Figures 3a-3b; see all of [0031]) comprising: extending an arm (trigger 86) coupled to a pawl (pawl 108) that is engaged with a rack (actuating member 92) in a first direction from an initial position (Figure 3A) to a final position (Figure 3B); in response to extending the arm, expelling a dose of the liquid drug from a drug container (fluid chambers 24, 26) of the drug delivery system by a plunger (plungers 36, 38) coupled to the rack (see all of [0030-0031]); rotating an end of the pawl (portion of pawl 108 engaged with teeth 112) relative to the arm (trigger 86) while the rack remains stationary to disengage the end of the pawl from at least a tooth of a plurality of teeth of the rack, wherein the rack remains stationary after an end of the pawl is disengaged from the tooth (“A release arm 114, which is coupled with the pawl 108, is accessible to the surgeon such that rearward biasing of the release arm 114 (i.e., toward the trigger 86), with or without a trigger pull, rotates the pawl 108 against the bias of the second torsion spring 110 and rotates the pawl 108 about the pawl pin 106 to withdraw the pawl 108 from the linear array of teeth 112 (FIG. 3C). Accordingly, the actuating member 92 may be retracted rearwardly and the fluid dispensing device 22 with holder 60 removed.” [0033]; Figure 3C shows the pawl 108 rotated relative to the trigger 86 to release from the actuating member 92. The actuating member 92 is stationary while this disengagement is occurring, and is then capable of being retracted after the release arm 114 has been rotated away from the teeth 112 but does not necessarily retract backward); in response to retracting the arm in a second direction, moving the pawl relative to the rack while the rack remains stationary; and stopping retracting of the arm in the second direction upon return to the initial position in preparation for expelling a following dose of the liquid drug (“when the trigger 86 is released, ratchets along the linear array of teeth 112 to engage a tooth 112 positioned proximate the now rest position.” [0030]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method for expelling a liquid drug from an on-body drug delivery system of Jeffrey to include rotating an end of the pawl relative to the arm while the rack remains stationary to disengage the end of the pawl from at least a tooth of a plurality of teeth of the rack based on the teachings of Kirk to allow the rack of the drug delivery system to be reset to the original, rearward starting position, such as when the reservoir is refilled (Kirk [0033]).
Regarding claim 11, modified Jeffrey teaches the method of claim 10, further comprising: re-engaging the rack by the pawl (pawl 153) when the arm stops retracting in the second direction (Figure 1B showing the pawl-carrier 150 in its initial position with the pawl 153 engaged with a tooth of the ratchet teeth 143).
Regarding claim 13, modified Jeffrey teaches the method of claim 10, wherein extending the arm (pawl carrier 150) in the first direction further comprises: advancing the plunger (piston 125) toward an end of the drug container (“The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 [140] is correspondingly moved and latched at 158/9…At least the preferred two-part piston-rod 140A, B of FIGS. 2C, D allows positive tolerance on ratchet action up to almost a second tooth pitch of movement without affecting accuracy of movement of the cartridge piston 125 by precisely one tooth pitch for each energisation of the solenoid 110.” [0036]; Figures 1A-1B).
Regarding claim 14, modified Jeffrey teaches the method of claim 10, further comprising: activating the power source (solenoid 110 powered by battery 170) coupled to the arm (pawl carrier 150) to deliver the dose of the liquid drug by causing the power source to extend the arm (“piston 125 capable of being forced down the main part 122 to unload the drugs etc contents 126.” [0030]; “The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 [140] is correspondingly moved and latched at 158/9…At least the preferred two-part piston-rod 140A, B of FIGS. 2C, D allows positive tolerance on ratchet action up to almost a second tooth pitch of movement without affecting accuracy of movement of the cartridge piston 125 by precisely one tooth pitch for each energisation of the solenoid 110.” [0036]).
Regarding claim 15, modified Jeffrey teaches the method of claim 14, further comprising: after returning to the initial position (Figure 1B), reactivating the power source to deliver the following dose of the liquid drug by causing the power source to extend the arm to expel the following dose of the liquid drug (“Preferred toothed pawl means is linearly driven, conveniently repeatedly by simple linear solenoid means” [0006]; “Energisation pulses to the solenoid 110 come from a clock source 182, which may be a standard clock/watch quartz crystal chip, through dose-interval selection circuitry 183 set according to requirements of successive dosing of a patient” [0038]).
Regarding claim 16, modified Jeffrey teaches the system of claim 1, wherein: the pawl is configured to be pulled by the arm when the power source retracts the arm (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; “The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward under the force of the spring 156, the pawl 153 deflects away/avoids the ratchet teeth 143).
Regarding claim 17, modified Jeffrey teaches the system of claim 1, wherein the pawl (pawl 153) is configured to: disengage the rack (piston-rod 140) through rotation of the end of the pawl (end of pawl 153; “The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; “The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward, the pawl carrier 150 and pawl 153 together rotate away and disengage from the ratchet teeth 143 as they deflect away).
Jeffrey fails to explicitly teach the pawl, prior to the arm retracting, is configured to disengage the rack through the rotation of the end of the pawl.
Kirk teaches a drug delivery system (fluid dispensing device 20) comprising: a rack (actuating member 92) having a plurality of teeth (teeth 112); an arm (trigger 86) having a pawl (pawl 108); and wherein the pawl, prior to the arm retracting, is configured to disengage the rack through the rotation of the end of the pawl (“A release arm 114, which is coupled with the pawl 108, is accessible to the surgeon such that rearward biasing of the release arm 114 (i.e., toward the trigger 86), with or without a trigger pull, rotates the pawl 108 against the bias of the second torsion spring 110 and rotates the pawl 108 about the pawl pin 106 to withdraw the pawl 108 from the linear array of teeth 112 (FIG. 3C).” [0033]; Figure 3C showing the pawl 108 disengages teeth 112 prior to the trigger 86 moving back to its first, retracted position).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the on-body drug delivery system of Jeffrey to include the pawl, prior to the arm retracting, is configured to disengage the rack through the rotation of the end of the pawl based on the teachings of Kirk to allow the rack of the drug delivery system to be reset to the original, rearward starting position, such as when the reservoir is refilled (Kirk [0033]).
Regarding claim 18, modified Jeffrey teaches the system of claim 1, wherein: an angle of the rack pushes the pawl away as the arm retracts (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; Figures 1A-1B showing that the sloped angle of each tooth of the ratchet teeth 143 allows for the pawl 153 to be deflected).
Regarding claim 19, modified Jeffrey teaches the system of claim 1, wherein: the pawl (pawl 153) is spring loaded (via spring 156) to avoid the rack (ratchet teeth 143 on piston-rod 140) as the arm (pawl carrier 150) retracts (“The pawl means may move the actuator in its drive stroke, or on its return stroke, and will usually deflect for its stroke not driving the actuator means” [0006]; “The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein as the pawl carrier 150 returns backward under the force of the spring 156, the pawl 153 deflects away/avoids the ratchet teeth 143).
Regarding claim 20, modified Jeffrey teaches the system of claim 1, wherein: the power source (solenoid 110 powered by battery 170 and return spring 156) is a motor or a linear actuator (“a linear solenoid 110 having a fixed coil 111 and reciprocably movable core 112.” [0030], wherein the linear solenoid 110 is a linear actuator because it is an actuator that creates linear motion) operable to extend and retract the arm (“The core 112 of the solenoid 110 engages the pawl carrier 150 in each drive pulse energisation of the coil 111, and drives the pawl carrier 150 with its pawl 153 by at least one pitch of the ratchet teeth 143. The piston-rod 150 is correspondingly moved and latched at 158/9. The pawl carrier 150 is returned by the spring 156 at the end of each energisation pulse for the solenoid coil 111.” [0036], wherein the power source as a whole is the combination of the solenoid 110 and the return spring 156, which cooperate to extend and retract the pawl carrier 150).
Response to Arguments
Applicant's arguments filed 02/11/26 have been fully considered but they are not persuasive.
Regarding the argument that neither Jeffrey not Kirk, alone or in combination disclose “an end of the pawl is configure to rotate relative to the arm while the rack remains stationary to disengage itself from a tooth of the plurality of teeth of the rack, wherein the rack remains stationary after the end of the pawl is disengaged from the tooth” as required by claim 1 and similarly recited in claim 10 (Remarks, page 6-8), the examiner respectfully disagrees. As detailed above, Jeffrey discloses an arm (150) having a pawl (53) configured to engage the rack ([0033]), wherein an end of the pawl is configured to disengage itself from a tooth of the plurality of teeth while the rack remains stationary ([0006]; [0036], wherein the pawl is deflected away/disengaged from the tooth on the return stroke and the rod 140 remains stationary due to latch 159), wherein the rack remains stationary after an end of the pawl is disengaged from the tooth ([0035], wherein the rod 140 remains stationary due to latching member 159). However, Jeffrey fails to explicitly disclose wherein an end of the pawl is configured to rotate relative to the arm while the rack remains stationary to disengage itself from a tooth of the plurality of teeth of the rack. Kirk teaches an arm (86) having a pawl (108) configured to engage the rack (92; Figures 3A-3B), wherein an end of the pawl (portion of pawl 108 engaged with teeth 112) is configured rotate relative to the arm while the rack remails stationary to disengage itself from a tooth of the plurality of teeth (112) of the rack (92), wherein the rack remains stationary after an end of the pawl is disengaged from the tooth ([0033]; Figure 3C shows the pawl 108 rotated relative to the trigger 86 to release from the actuating member 92. The actuating member 92 is stationary while this disengagement is occurring, and is then capable of being retracted after the release arm 114 has been rotated away from the teeth 112 but does not necessarily move backward). It is maintained that it would have been obvious to one having ordinary skill in the art to modify the pawl of the on-body drug delivery system of Jeffrey to include that an end of the pawl is configured to rotate relative to the arm while the rack remains stationary to disengage itself from a tooth of the plurality of teeth of the rack based on the teachings of Kirk to allow the rack of the drug delivery system to be reset to the original, rearward starting position, such as to refill the reservoir (Kirk [0033]).
Regarding the argument that “the rack of Kirk does not remain stationary after disengagement from the pawl” (Remarks, page 7), the disclosure of Kirk does not state that the disclosed rack must or inherently retract when the pawl is disengaged. Rather, Kirk discloses that the rack “may” or is capable of retracting after the pawl has rotated and disengaged from a tooth (“A release arm 114, which is coupled with the pawl 108, is accessible to the surgeon such that rearward biasing of the release arm 114 (i.e., toward the trigger 86), with or without a trigger pull, rotates the pawl 108 against the bias of the second torsion spring 110 and rotates the pawl 108 about the pawl pin 106 to withdraw the pawl 108 from the linear array of teeth 112 (FIG. 3C). Accordingly, the actuating member 92 may be retracted rearwardly and the fluid dispensing device 22 with holder 60 removed.” [0033]). Figure 3C shows the pawl 108 rotated relative to the trigger 86 to release from the actuating member 92. The actuating member 92 is stationary while this disengagement is occurring, and is then capable of remaining stationary after the release arm 114 has been rotated away from the teeth 112. Additionally, the limitation “wherein the rack remains stationary after the end of the pawl is disengaged from the tooth” was found in the disclosure of Jeffrey, as detailed above. Jeffrey discloses a rack that remains stationary after an end of the pawl is disengaged from the tooth (“Another abutment 158 within the holder body serves to control one-way flexing of a latching member 159 for the ratchet- teeth 143.” [0035], wherein the rod 140 remains stationary due to latching member 159).
Regarding the argument that there is not motivation to combine the cited references because “such a modification would render Jeffrey inoperable for its intended purpose” (Remarks, page 8-9), the examiner respectfully disagrees. Jeffrey requires that the pawl must deflect to disengage from one tooth to then re-engage with the next tooth position. Kirk also discloses that the pawl engages a tooth, then deflects to re-engage with next tooth (“With sufficient engagement of the trigger 86 and forward movement of the pawl 108, the actuating member 92 moves forward a sufficient distance so that the pawl 108, when the trigger 86 is released, ratchets along the linear array of teeth 112 to engage a tooth 112 positioned proximate the now rest position.” [0030]). Kirk then additionally discloses that the pawl can be rotated to fully disengage from the rack regardless of the positioning of the arm (“rearward biasing of the release arm 114 (i.e., toward the trigger 86), with or without a trigger pull, rotates the pawl 108 against the bias of the second torsion spring 110 and rotates the pawl 108 about the pawl pin 106 to withdraw the pawl 108 from the linear array of teeth 112 (FIG. 3C).” [0033]). Both Jeffrey and Kirk disclose that the rack, arm, and pawl form a one-way rachet mechanism (Jeffrey: “Preferred incremental drive transmission means is of ratchet-type. Intermittently driven toothed pawl means can serve for movement of toothed actuator means in a one-way and non-returnable incremental manner” [0006] and Kirk: “the pawl 108 is designed as a one-way ratchet” [0033]). Therefore, one having ordinary skill in the art would recognize that modifying the pawl of Jeffrey to be configured to rotate relative to the arm to disengage the rack based on the disclosure of Kirk, which teaches a similar one-way rachet mechanism, to allow the rack of the drug delivery system to be reset to the original, rearward starting position, such as to refill the reservoir (Kirk [0033]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783