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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 38 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 38 recites “an actuator having a coupling end coupled to each of the first one pinion drive and the second pinion drive”. The phrase “the first one pinion drive” lacks proper antecedent basis and contains an extraneous word “one”. The claim previously introduces “a first pinion drive”. The claim should read “the first pinion drive”. As written, the claim fails to particularly point out and distinctly claim the subject matter because the antecedent basis is unclear.
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 21-26, 29-32, and 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al. (US2005/0165363; hereinafter “Judson”) in view of Jacobs et al. (US 2007/0197976A1; hereinafter “Jacobs”).
In relation to independent claim 21, this claim recites:
a plunger drive system for a medication delivery device, the system comprising: a plunger having an elongated body with a plurality of ratchet teeth;
an output drive member having one or more pawled ends movably coupled with the ratchet teeth of the plunger;
at least one pinion drive operably engaged by the output drive member; and
an actuator having a coupling end coupled to the at least one pinion drive and a button end, the actuator longitudinally movable between an extended position and a retracted position,
wherein, in response to proximal movement of the actuator to the extended position from the retracted position, rotation of the at least one pinion drive is in a first direction to proximally translate the output drive member relative to the plunger to a dose set position, the one or more pawled ends of the output drive member moving along the ratchet teeth of the plunger, wherein, in response to distal movement of the actuator to the retracted position from the extended position, rotation of the at least one pinion drive is in a second direction, opposite the first direction, to distally translate the output drive member, the one or more pawled ends of the output drive member in engagement with at least one of the ratchet teeth of said plunger, thereby advancing the plunger in a distal direction.
A plunger drive system for a medication delivery device, the system comprising: a plunger having an elongated body with a plurality of ratchet teeth;
Judson discloses a plunger drive system for a medication delivery device. Specifically, Judson discloses: “[t]he present invention provides a medication dispensing apparatus including a housing, a drive member within the housing and movable in a distal direction, a fluid container defining a medicine-filled reservoir with a movable piston at one end and an outlet at the other end, the piston engagable by the drive member to be advanced toward the outlet when the drive member is moved distally”. (Judson ¶ [0007].) Judson further discloses: “[d]rive member 62 is in the form of an axially translatable, rotatably fixed element. On the upper, otherwise generally planar face of its rectangular rod shaped body, drive member 62 includes a row of ratchet teeth 78 that continue uninterrupted along nearly its entire length.” (Judson ¶ [0053].) Note: Judson’s “drive member 62” corresponds to the claimed “plunger” that advances the piston.
an output drive member having one or more pawled ends movably coupled with the ratchet teeth of the plunger;
Judson discloses an output drive member coupled to the plunger. Specifically, Judson discloses: “the present invention provides a medication dispensing apparatus including a housing, and a drive member within the housing and including a first piece and a second piece. The first piece is movable in a distal direction, the second piece is clutchably connected to the first piece to be moveable relative thereto in a proximal direction but not the distal direction”. (Judson ¶ [0010].) To the extent Judson does not expressly disclose the output drive member having one or more pawled ends movably coupled with the ratchet teeth of the plunger, Jacobs fills this gap by disclosing an output drive member having pawled ends movably coupled to ratchet teeth. Specifically, Jacobs discloses: “[p]roximally of pawls 72, a pair of diametrically opposed resilient pawls 75 of pinion-engaging piece 62 also engage the same rows of ratchet teeth 70 on opposite sides of body 64. Pawls 75 slide along and over one or more teeth 70 when pinion-engaging piece 62 is moved proximally during pen cocking, but abut teeth 70 during the distal advancement of pinion-engaging piece 62 during injection”. (Jacobs ¶ [0032].)
at least one pinion drive operably engaged by the output drive member;
Judson discloses at least one pinion drive operably engaged by the output drive member. Specifically, Judson discloses: “[t]he interconnecting means includes a gear set including a first pinion in meshed engagement with a rack of the plunger and a second pinion in meshed engagement with a rack of the drive member.” (Judson ¶ [0007].)
and an actuator having a coupling end coupled to the at least one pinion drive and a button end, the actuator longitudinally movable between an extended position and a retracted position, wherein, in response to proximal movement of the actuator to the extended position from the retracted position, rotation of the at least one pinion drive is in a first direction to proximally translate the output drive member relative to the plunger to a dose set position, the one or more pawled ends of the output drive member moving along the ratchet teeth of the plunger;
Judson discloses an actuator longitudinally movable that rotates the pinion drive in a first direction. Specifically, Judson discloses: “[p]lunging member 66 is injection molded from a lightweight material such as plastic… Plunger 66 includes a grip portion 90 extending proximally of housing 60. Grip portion 90 is externally accessible to be manually pulled by a user for pen cocking purposes.” (Judson ¶ [0057].) Judson further discloses: “[w]hen the plunger is shifted from the distal position to the proximal position, the first pinion rolls along the longitudinally fixed rack and the plunger rack, and the second pinion rolls along the drive member rack and rotates relative to the first pinion in a direction opposite to the first direction.” (Judson ¶ [0009].) Jacobs discloses the pawled ends moving along the ratchet teeth: “[p]awls 75 slide along and over one or more teeth 70 when pinion-engaging piece 62 is moved proximally during pen cocking”. (Jacobs ¶ [0032].)
wherein, in response to distal movement of the actuator to the retracted position from the extended position, rotation of the at least one pinion drive is in a second direction, opposite the first direction, to distally translate the output drive member, the one or more pawled ends of the output drive member in engagement with at least one of the ratchet teeth of said plunger, thereby advancing the plunger in a distal direction.
Judson discloses distal movement causing opposite rotation to advance the plunger. Specifically, Judson discloses: “[w]hen the plunger is shifted from the proximal position to the distal position, the first pinion rolls along the longitudinally fixed rack and the plunger rack and the second pinion rolls along the drive member rack while simultaneously, due to it being unidirectionally coupled with the first pinion, forcing the drive member to move in the distal direction to advance the movable piston toward the outlet.” (Judson ¶ [0009].) Jacobs discloses the pawled ends engaging the teeth: “abut teeth 70 during the distal advancement of pinion-engaging piece 62 during injection, which abutting results in pinion-engaging piece 62 shifting distally the cartridge-engaging piece 60.” (Jacobs ¶ [0032].)
Motivation to combine.
It would have been obvious to combine Judson with Jacobs because both references relate to rack-and-pinion driven medication dispensing devices. A person of ordinary skill in the art would have been motivated to incorporate Jacobs’s specific pawled-end pinion-engaging piece into Judson’s gear set system to provide a robust, reliable one-way clutch mechanism between the drive member components during dose setting and delivery.
In relation to claim 22, this depends from claim 21 and further recites: wherein a surface of the actuator is slidably engaged along a surface of the output drive member.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
wherein a surface of the actuator is slidably engaged along a surface of the output drive member.
Judson discloses a surface of the actuator slidably engaged along a surface of the output drive member. Specifically, Judson discloses: “[t]he hollow interior 97 of tubular portion 96 accommodates the proximal end of drive member 62.” (Judson ¶ [0058].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs because providing sliding engagement between the actuator and the drive member would have ensured proper axial alignment during the plunging motion, as recognized by a person of ordinary skill in the art.
In relation to claim 23, this claim depends from claim 21 and further recites: wherein one of the actuator or the output drive member includes a guide element, and the other of the actuator or the output drive member includes a rail element in slidable contact with the guide element.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
wherein one of the actuator or the output drive member includes a guide element, and the other of the actuator or the output drive member includes a rail element in slidable contact with the guide element.
Judson discloses guiding features: “[t]he outer periphery of plunger tubular portion 96 is non-circular and fits closely within the correspondingly shaped housing 60.” (Judson ¶ [0058].) To the extent Judson does not expressly disclose the actuator and output drive member having specific guide and rail elements, Jacobs fills this gap by disclosing: “[a] pair of parallel, longitudinally extending ribs 82 project from the opposite side of body 77 and slidable receive rod-shaped body 64 therebetween.” (Jacobs ¶ [0033].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs because utilizing guide ribs and rails ensures stable, linear translation of the components during dose setting and delivery, preventing jamming.
In relation to claim 24, this claim depends from claim 23 and further recites: wherein the actuator includes said rail element, and the output drive member includes the guide element.
Base rejection incorporated.
The rejection of claim 23 is incorporated herein.
wherein the actuator includes said rail element, and the output drive member includes the guide element.
Jacobs discloses the guide element on the output drive member. Specifically, Jacobs discloses: “[a] pair of parallel, longitudinally extending ribs 82 project from the opposite side of body 77 and slidable receive rod-shaped body 64 therebetween.” (Jacobs ¶ [0033].)
Motivation to combine. It would have been obvious to combine the base combination of Judson and Jacobs to arrange the guide and rail elements as taught by Jacobs to ensure stable axial alignment.
In relation to claim 25, this depends from claim 24 and further recites: wherein the guide element comprises a pair of axially extending parallel guide ribs extending along the output drive member, and the actuator defines the rail element that is sized to fit within a space defined by the axially extending parallel guide ribs.
Base rejection incorporated.
The rejection of claim 24 is incorporated herein.
wherein the guide element comprises a pair of axially extending parallel guide ribs extending along the output drive member, and the actuator defines the rail element that is sized to fit within a space defined by the axially extending parallel guide ribs.
Jacobs discloses a pair of axially extending parallel guide ribs. Specifically, Jacobs discloses: “[a] pair of parallel, longitudinally extending ribs 82 project from the opposite side of body 77 and slidable receive rod-shaped body 64 therebetween.” (Jacobs ¶ [0033].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to utilize the parallel ribs taught by Jacobs to securely guide the components.
In relation to claim 26, this claim depends from claim 25 and further recites: wherein the actuator includes a lateral shelf extending laterally from one or both sides of the actuator, said lateral shelf is in sliding contact with an upper surface of the axially extending parallel guide ribs.
Base rejection incorporated.
The rejection of claim 25 is incorporated herein.
wherein the actuator includes a lateral shelf extending laterally from one or both sides of the actuator, said lateral shelf is in sliding contact with an upper surface of the axially extending parallel guide ribs.
Jacobs discloses a lateral shelf in sliding contact with ribs. Specifically, Jacobs discloses: “[a]nother set of parallel rib portions 83 are shaped to slide along a ridge 45 formed on the interior surface 39 of housing half 38.” (Jacobs ¶ [0033].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to provide lateral sliding surfaces to further stabilize the linear motion of the drive system.
In relation to claim 29, this claim depends from claim 21 and further recites: wherein the output drive member is configured to receive longitudinally the plunger.
Base rejection incorporated. The rejection of claim 21 is incorporated herein.
wherein the output drive member is configured to receive longitudinally the plunger.]
Jacobs discloses the output drive member receiving the plunger longitudinally. Specifically, Jacobs discloses: “[a] pair of parallel, longitudinally extending ribs 82 project from the opposite side of body 77 and slidable receive rod-shaped body 64 therebetween.” (Jacobs ¶ [0033].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to configure the output drive member to receive the plunger body longitudinally to maintain a compact, concentric arrangement of the drive components.
In relation to claim 30, this claim depends from claim 29 and further recites: wherein the output drive member includes a tab, and the plunger defines a longitudinal slot configured to receive said tab.
Base rejection incorporated.
The rejection of claim 29 is incorporated herein.
wherein the output drive member includes a tab, and the plunger defines a longitudinal slot configured to receive said tab.
Judson discloses a slot and tab/stop arrangement. Specifically, Judson discloses: “[a] preferred manner of controlling plunger range includes a longitudinally extending recess or groove 104 formed in the exterior periphery of tubular portion 96… A dose stop 108, shown in the form of a parallelepiped projection, fits within groove 104”. (Judson ¶ [0059].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to utilize a tab and longitudinal slot to limit the relative longitudinal travel between the components and establish dose volumes.
In relation claim 31, this depends from claim 30 and further recites: wherein the longitudinal slot is defined by a proximal lip configured to contact the tab to prevent further relative movement between the output drive member and the plunger when there is an insufficient remaining dose of medication.
Base rejection incorporated.
The rejection of claim 30 is incorporated herein.
wherein the longitudinal slot is defined by a proximal lip configured to contact the tab to prevent further relative movement between the output drive member and the plunger when there is an insufficient remaining dose of medication.
Judson discloses an insufficient dose prevention mechanism based on abutment. Specifically, Judson discloses: “[t]his insufficiency is indicated to a user by her inability to fully withdraw plunger 66 due to pinion 126 abutting flaired end 82 of drive member 62.” (Judson ¶ [0074].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to provide a hard stop (lip contacting a tab) to prevent dose setting when insufficient medication remains, thereby ensuring patient safety.
In relation to claim 32, this claim depends from claim 21 and further recites: wherein the output drive member has a first pawled end and a second pawled end, the first pawled end and the second pawled end movably coupled with the corresponding ratchet teeth along opposite sides of the plunger.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
wherein the output drive member has a first pawled end and a second pawled end, the first pawled end and the second pawled end movably coupled with the corresponding ratchet teeth along opposite sides of the plunger.
Jacobs discloses pawled ends coupled with ratchet teeth on opposite sides. Specifically, Jacobs discloses: “a pair of diametrically opposed resilient pawls 75 of pinion-engaging piece 62 also engage the same rows of ratchet teeth 70 on opposite sides of body 64.” (Jacobs ¶ [0032].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to provide pawls on opposite sides of the plunger to balance the driving forces and prevent asymmetrical loading or binding.
In relation to claim 34, this claim depends from claim 21 and further recites: wherein the output drive member includes a guide element comprising a guide rib extending axially along the output drive member, wherein the actuator is in sliding contact with the guide rib.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
wherein the output drive member includes a guide element comprising a guide rib extending axially along the output drive member, wherein the actuator is in sliding contact with the guide rib.
Jacobs discloses guide ribs extending axially. Specifically, Jacobs discloses: “[a] pair of parallel, longitudinally extending ribs 82 project from the opposite side of body 77 and slidable receive rod-shaped body 64 therebetween.” (Jacobs ¶ [0033].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to include axial guide ribs to maintain alignment between the actuator and the output drive member during sliding contact.
In relation to claim 35, this claim depends from claim 21 and further recites: wherein the actuator includes a first coupler configured to couple to a first pinion drive of the at least one pinion drive, and a second coupler configured to couple to a second pinion drive of the at least one pinion drive.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
wherein the actuator includes a first coupler configured to couple to a first pinion drive of the at least one pinion drive, and a second coupler configured to couple to a second pinion drive of the at least one pinion drive.
Jacobs discloses an actuator coupling to the pinion drives. Specifically, Jacobs discloses: “[y]oke 116 receives the pin 120 of the gear set, which pin defines an axis about which the gear set partially revolves or pivots during use.” (Jacobs ¶ [0038].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to provide couplers (like yokes) to securely mount the dual pinions to the actuator.
In relation to claim 36, this claim depends from claim 21 and further recites: wherein the at least one pinion drive includes a first pinion drive and a second pinion drive disposed along opposite sides of the output drive member, wherein each of the first pinion drive and the second pinion drive includes a first set of teeth and a second set of teeth.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
wherein the at least one pinion drive includes a first pinion drive and a second pinion drive disposed along opposite sides of the output drive member, wherein each of the first pinion drive and the second pinion drive includes a first set of teeth and a second set of teeth.
Judson discloses pinion drives with multiple sets of teeth. Specifically, Judson discloses: “[t]he gear set… utilizes first and second sized pinions… The first or larger sized pinions 114 are each formed by a ring 115 with external gear teeth 116… Pinion 126 includes external gear teeth 127”. (Judson ¶ [0062]-[0065].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to utilize dual pinions with multiple sets of teeth of different pitch diameters to achieve the desired mechanical advantage.
In relation to claim 37, this claim recites: a medication delivery device, comprising: a housing; a medication cartridge comprising a piston disposed therein; the plunger drive system of claim 21, the plunger drive system configured to advance the piston.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
A medication delivery device, comprising: a housing; a medication cartridge comprising a piston disposed therein; the plunger drive system of claim 21, the plunger drive system configured to advance the piston.
Judson discloses a medication delivery device with a housing and cartridge. Specifically, Judson discloses: “[t]he present invention provides a medication dispensing apparatus including a housing, a drive member within the housing and movable in a distal direction, a fluid container defining a medicine-filled reservoir with a movable piston at one end and an outlet at the other end, the piston engagable by the drive member to be advanced toward the outlet when the drive member is moved distally”. (Judson ¶ [0007].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to implement the improved plunger drive system within a complete medication delivery device housing and cartridge to deliver precise doses.
In relation to independent claim 38, this claim recites: a plunger drive system for a medication delivery device, the system comprising:
a plunger having an elongated body with a plurality of ratchet teeth along opposite sides of the elongated body;
an output drive member having a first pawled end and a second pawled end movably coupled with the corresponding ratchet teeth of the opposite sides of the plunger;
a first pinion drive and a second pinion drive operably engaged by the output drive member;
and an actuator having a coupling end coupled to each of the first one pinion drive and the second pinion drive, the actuator longitudinally movable between an extended position and a retracted position, wherein, in response to proximal movement of the actuator to the extended position from the retracted position, rotation of each of the first and second pinion drives is in a first direction to proximally translate the output drive member relative to the plunger to a dose set position, each of the first and second pawled ends of the output drive member moving along the corresponding ratchet teeth of the opposite sides of the plunger,
wherein, in response to distal movement of the actuator to the retracted position from the extended position, rotation of each of the first and second pinion drives is in a second direction, opposite the first direction, to distally translate the output drive member, each of the first and second pawled ends of the output drive member in engagement with the corresponding ratchet teeth of the opposite sides of the plunger, thereby advancing the plunger in a distal direction.
A plunger drive system for a medication delivery device, the system comprising: a plunger having an elongated body with a plurality of ratchet teeth along opposite sides of the elongated body;
Judson discloses a plunger drive system with a plunger having ratchet teeth. Specifically, Judson discloses: “[t]he present invention provides a medication dispensing apparatus including a housing, a drive member within the housing and movable in a distal direction, a fluid container defining a medicine-filled reservoir with a movable piston at one end and an outlet at the other end”. (Judson ¶ [0007].) Judson further discloses: “[d]rive member 62 is in the form of an axially translatable, rotatably fixed element. On the upper, otherwise generally planar face of its rectangular rod shaped body, drive member 62 includes a row of ratchet teeth 78”. (Judson ¶ [0053].) To the extent Judson does not expressly disclose ratchet teeth on opposite sides, Jacobs fills this gap by disclosing: “ratchet teeth 70 on opposite sides of body 64.” (Jacobs ¶ [0032].)
an output drive member having a first pawled end and a second pawled end movably coupled with the corresponding ratchet teeth of the opposite sides of the plunger;
Judson discloses an output drive member coupled to the plunger. Specifically, Judson discloses: “the present invention provides a medication dispensing apparatus including a housing, and a drive member within the housing and including a first piece and a second piece. The first piece is movable in a distal direction, the second piece is clutchably connected to the first piece to be moveable relative thereto in a proximal direction but not the distal direction”. (Judson ¶ [0010].) To the extent Judson does not expressly disclose the output drive member having first and second pawled ends, Jacobs fills this gap by disclosing: “a pair of diametrically opposed resilient pawls 75 of pinion-engaging piece 62 also engage the same rows of ratchet teeth 70 on opposite sides of body 64.” (Jacobs ¶ [0032].)
a first pinion drive and a second pinion drive operably engaged by the output drive member;
Judson discloses pinion drives engaged by the output drive member. Specifically, Judson discloses: “[t]he interconnecting means includes a gear set including a first pinion in meshed engagement with a rack of the plunger and a second pinion in meshed engagement with a rack of the drive member.” (Judson ¶ [0007].)
and an actuator having a coupling end coupled to each of the first pinion drive and the second pinion drive, the actuator longitudinally movable between an extended position and a retracted position, wherein, in response to proximal movement of the actuator to the extended position from the retracted position, rotation of each of the first and second pinion drives is in a first direction to proximally translate the output drive member relative to the plunger to a dose set position, each of the first and second pawled ends of the output drive member moving along the corresponding ratchet teeth of the opposite sides of the plunger,
Judson discloses an actuator longitudinally movable that rotates the pinion drives in a first direction. Specifically, Judson discloses: “[p]lunger 66 includes a grip portion 90 extending proximally of housing 60. Grip portion 90 is externally accessible to be manually pulled by a user for pen cocking purposes.” (Judson ¶ [0057].) Judson further discloses: “[w]hen the plunger is shifted from the distal position to the proximal position, the first pinion rolls along the longitudinally fixed rack and the plunger rack, and the second pinion rolls along the drive member rack and rotates relative to the first pinion in a direction opposite to the first direction.” (Judson ¶ [0009].) Jacobs discloses the pawled ends moving along the ratchet teeth: “[p]awls 75 slide along and over one or more teeth 70 when pinion-engaging piece 62 is moved proximally during pen cocking”. (Jacobs ¶ [0032].)
wherein, in response to distal movement of the actuator to the retracted position from the extended position, rotation of each of the first and second pinion drives is in a second direction, opposite the first direction, to distally translate the output drive member, each of the first and second pawled ends of the output drive member in engagement with the corresponding ratchet teeth of the opposite sides of the plunger, thereby advancing the plunger in a distal direction.
Judson discloses distal movement causing opposite rotation to advance the plunger. Specifically, Judson discloses: “[w]hen the plunger is shifted from the proximal position to the distal position, the first pinion rolls along the longitudinally fixed rack and the plunger rack and the second pinion rolls along the drive member rack while simultaneously, due to it being unidirectionally coupled with the first pinion, forcing the drive member to move in the distal direction to advance the movable piston toward the outlet.” (Judson ¶ [0009].) Jacobs discloses the pawled ends engaging the teeth: “abut teeth 70 during the distal advancement of pinion-engaging piece 62 during injection, which abutting results in pinion-engaging piece 62 shifting distally the cartridge-engaging piece 60.” (Jacobs ¶ [0032].)
Motivation to combine.
It would have been obvious to combine Judson with Jacobs because both references relate to rack-and-pinion driven medication dispensing devices. A person of ordinary skill in the art would have been motivated to incorporate Jacobs’s specific dual-pawled pinion-engaging piece into Judson’s gear set system to provide a robust, balanced one-way clutch mechanism between the drive member components during dose setting and delivery.
Claims 27, 28, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Judson et al. (US2005/0165363; hereinafter “Judson”) in view of Jacobs et al. (US 2007/0197976A1; hereinafter “Jacobs”), as discussed above, and in further view of Jacobs et al. (US 2007/0191784A1; hereinafter “Jacobs II”).
In relation to claim 27, this claim depends from claim 21 and further recites: wherein the at least one pinion drive includes a first pinion drive and a second pinion drive disposed along opposite sides of the output drive member, wherein the output drive member includes a first rack and a second rack, wherein the first pinion drive is engaged with the first rack, and the second pinion drive is engaged with the second rack.
Base rejection incorporated.
The rejection of claim 21 is incorporated herein.
wherein the at least one pinion drive includes a first pinion drive and a second pinion drive disposed along opposite sides of the output drive member, wherein the output drive member includes a first rack and a second rack, wherein the first pinion drive is engaged with the first rack, and the second pinion drive is engaged with the second rack.
Judson discloses multiple pinion drives. Specifically, Judson discloses: “[t]he larger pinions 114 are two in number and flank a smaller pinion 126”. (Judson ¶ [0063].) To the extent Judson does not expressly disclose the pinions on opposite sides with dual racks, Jacobs II fills this gap. Specifically, Jacobs II discloses: “[p]inion-engaging piece 70 includes a pair of laterally spaced, longitudinally extending racks 80.” (Jacobs II ¶ [0042].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs with Jacobs II to utilize dual pinions and dual racks on opposite sides to balance the driving forces and prevent binding of the output drive member.
In relation to claim 28, this claim depends from claim 27 and further recites: wherein each of the first pinion drive and the second pinion drive includes a pin, wherein the actuator includes a first slot receiving the pin of the first pinion drive, and a second slot receiving the pin of the second pinion drive.
Base rejection incorporated.
The rejection of claim 27 is incorporated herein.
wherein each of the first pinion drive and the second pinion drive includes a pin, wherein the actuator includes a first slot receiving the pin of the first pinion drive, and a second slot receiving the pin of the second pinion drive.
Jacobs discloses the pinions having a pin received in a slot/yoke. Specifically, Jacobs discloses: “[y]oke 116 receives the pin 120 of the gear set, which pin defines an axis about which the gear set partially revolves or pivots during use.” (Jacobs ¶ [0038].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs to mount the pinions using an axle pin received in an actuator yoke/slot to securely couple the gear set to the actuator for linear translation.
In relation to claim 33, this claim depends from claim 32 and further recites: wherein the output drive member includes a first rack engageable with a first pinion drive of the at least one pinion drive, and a second rack engageable with a second pinion drive of the at least one pinion drive.
Base rejection incorporated.
The rejection of claim 32 is incorporated herein.
wherein the output drive member includes a first rack engageable with a first pinion drive of the at least one pinion drive, and a second rack engageable with a second pinion drive of the at least one pinion drive.
Jacobs II discloses multiple racks. Specifically, Jacobs II discloses: “[p]inion-engaging piece 70 includes a pair of laterally spaced, longitudinally extending racks 80.” (Jacobs II ¶ [0042].)
Motivation to combine.
It would have been obvious to combine the base combination of Judson and Jacobs with Jacobs II to utilize dual racks and pinions to evenly distribute the mechanical driving forces across the gear set.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
Prosecution Insights