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 § 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, 3-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni et al. (WO 2006104806 A2) in view of Gross et al. (US 20030236498 A1) in view of Mahoney et al. (US 2003199824 A1) in further view of Gorman et al. (US 7144384 B2)
Regarding Claim 1, Dilanni discloses a unilaterally driven drug infusion device (fluid delivery device 200, Fig 1; [0038] Device is driven unilaterally by the linear actuator at different time instances) with multiple infusion modes ([0040]), the drug infusion device (200) comprising: a reservoir (reservoir 230, Fig 10), a piston (plunger 236, Fig 5) and a screw (threaded drive rod 252, Fig 5), wherein the piston (236) is connected with the screw (252), and is arranged in the reservoir (230) ([0032]: “a threaded drive rod 252 coupled to a plunger 236. The plunger 236 is received in the fluid reservoir 230”); a driving unit (drive engaging member 262 and pivot point 162, Fig 4) including at least one rotating shaft (pivot point 162, Fig 4) and at least one driving member (drive engaging member 262, Fig 5) ([0035]: “the pivotable drive engaging member 262 may only include one arm and one leg.”), wherein the driving member (262) includes at least one driving end (arm 264a, [0035]), and the driving member (262) is able to rotate around the rotating shaft (162) ([0036]: “The pivotable drive engaging member 262 may be pivotably coupled to a pivot point 162”) to advance or reset the driving end (264a) ([0038]: “When the pivotable drive engaging member 262 pivots in the first direction 20, the arm 264a engages a tooth on the ratchet wheel portion 258a causing the drive wheel 256 to rotate one increment”; at least one driving wheel (drive wheel 256, Fig 5) provided with wheel teeth (wheel teeth 1000, Annotated Fig 1), the driving end (264a), which advances is able push the wheel teeth (1000) to rotate the driving wheel (256), and drive the screw (252) to move forward ([0032],[0038]) ; a linear actuator (First SMA wire portion 260a) and a reset unit (second SMA wire portion 260b) respectively connected to the driving member (262) (Fig 5 shows the connection of 260b to 262), wherein the linear actuator (260a) and the reset unit (260b) respectively apply driving power to the driving member (262) to advance ([0038]: “When charged, the first SMA wire portion 260a contracts and pulls the pivotable drive engaging member 262 in a first direction indicated by arrow 20”) and reset ([0038]; Engagement member 262 has one arm 264 and a leg 268; which is rotatable between the contacts; when the current is disable the shape memory alloy wire 260a return to its initial position and 260b contracts; since member 262 has only one arm contraction of 260b will not cause movement of wheel 256) the driving end (264; [0035]); and a control unit (control circuitry ,not shown; [0038]), connected to the linear actuator (260a) or the reset unit (260b), wherein the control unit (control circuitry ,not shown; [0038]) controls the linear actuator (260a) or the reset unit (260b) ([0038]) to apply different driving powers ([0038]) on the driving member (262) to make the driving member (262) have a variety of different operating modes ([0040]), such that the infusion device has various different infusion increments or infusion rates ([0040]: “the discrete amount of fluid to be dispensed is between about 0.25 μL and about 0.5 μL. The control circuitry alternates energizing the SMA wire portions 260a, 260b until a desired amount of fluid has been dispensed”), wherein the variety of different operating modes include different rotation amplitudes of the driving member ([0040]:The total distance traveled by each rotational movement actuated by SMA wire 260a in the first direction 20 of the driving unit, which also represents the distance the piston is being moved. SMA wire 260b will contribute to resetting because only one arm 264 is present. The total distance or amplitude traveled differs based on desired injection amount and therefore different infusion mode) wherein the control unit (control circuitry ,not shown; [0038]) is configured to control a magnitude of a force output of the linear actuator (control circuit [0038] controls each actuation of the SMA wire which exerts a force of specific magnitude) to make the driving member (262) have the different rotation amplitudes (The total distance traveled by each rotational movement actuated by SMA wire 260a in the first direction 20 of the driving unit), and each of the different rotation amplitudes (the total distance traveled by each rotational movement actuated by SMA wire 260a in the first direction 20 of the driving unit) corresponds with a respective infusion increment (each of the different total distances corresponds to different infusion increments); a base (chassis 100, Fig 9), wherein the driving wheel is movably assembled on the base (100) ([0014]), and the base (100) and the driving wheel (256) are frictional fit ([0014]; Since the hub is supported by bearing surfaces on the chassis 100, there is contact between these components; therefore, there is friction fit between the chassis bearing surfaces and the wheel 256.), during reset, the driving end (264; [0035]) only slides on a surface of the wheel (256) teeth (1000, Annotated Fig 1) without pushing ([0038]; Engagement member 262 has one arm 264 and a leg 268; which is rotatable between the contacts; when the current is disabled the shape memory alloy wire 260a return to its initial position and 260b contracts, comprising the reset motion; rotation of the arm 264 in the second direction does not push the driving wheel); and a position limited member (tilt nut 242, Fig 11A-B), wherein the position limited member (242) is movably assembled on the base (100) to limit a position of the driving wheel (256), and the position limited member (242) and the driving wheel (256) are frictional fit (tilt nut 242 is in frictional fitment in relation of the drive wheel 256, when the tilt nut 242 is in the closed position movement of the drive wheel is being transferred to the tilt nut which threads engages the drive rod 252 to dispense the medicine; [0046]); when the linear actuator (260a and 260b) pulls the driving member (262), the driving member (262) rotates in an advancing direction (direction 20, Fig 5) around the rotating shaft (162); and the driving direction (20) is opposite to the reset direction (22).
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Dilanni is silent regarding wherein the driving wheel stops rotating when the driving end is sliding on the surface of the wheel teeth; wherein the position limited member is configured to increase a frictional force that the driving wheel receives when rotating, ensuring that the driving wheel stops rotating when the driving end slides on the surface of the wheel teeth; the reset unit is pressed by the driving member to build a gradually increasing elastic force, when the linear actuator stops applying force and under the action of only the elastic force, the driving member rotates in a reset direction around the rotating shaft, at this time, the driving ends slides on the surface of the wheel teeth.
Gross teaches a drug infusion device (precision of device 10, Fig 1) comprising a driving member (pawl 18, Fig 4-5) including two driving ends (31, 32, Fig 4-5) disposed at a same side (distal side of the pawl 18 towards the first end 15, Fig 1) and disposed up and down and cooperating with the same driving element (Fig 4-5 shows the pawls ends 31 and 32 disposed up and down cooperating with the same ratchet bar), the driving ends (31, 32) are able to reciprocate synchronously (both pawl ends 31, 32 reciprocate synchronously when the pawl 18 is being driven; [0103]), front ends of the driving ends are not level with a distance (distal end of 31 is longer than distal end of 32 by a distance; [0103]), and the two driving ends cannot simultaneously push the driving element teeth forward ([0103]; reciprocating motion of pawl 18 only engages one end 31 or 32 at time with teeth 33, 33); a reset unit (return spring 29, Fig 1) is pressed by the driving member (lever 19, Fig 1) to build a gradually increasing elastic force, when the linear actuator (gas generator 25, Fig 1) stops applying force ([0102]) and under the action of only the elastic force (elastic force of return spring 29, Fig 1), the driving member (19) rotates in a reset direction around the rotating shaft (axis 20, Fig 1)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the arm of device of Dilanni with similar pawl ends and reset unit as taught by Gross for delivering small volumes in a stepwise fashion, increasing the accuracy of the volumes being dispensed ([107]; [0126]).
Dilanni/Gross discloses the driving ends (modified arm of Dilanni with teaching of Gross as combined) slides on the surface of the wheel teeth (1000, Annotated Fig 1 Dilanni) (arm 264 of Dilanny, including driving ends as modified with teaching of Gross slides over the wheel 256 when moved in direction 22 because only one arm is present).
Dilanni/Gross are silent the driving wheel stops rotating when the driving end is sliding on the surface of the wheel teeth; wherein the position limited member is configured to increase a frictional force that the driving wheel receives when rotating, ensuring that the driving wheel stops rotating when the driving end slides on the surface of the wheel teeth.
Mahoney teaches an infusion device (infusion devise dispenser 10, Fig 2) comprising: a reservoir (reservoir 30, Fig 6), a piston (plunger 204, Fig 6) and a screw (threaded lead screw 202, Fig 3), the piston (204), connected with the screw (202), is arranged in the reservoir (30) ([0082]); a driving member (moveable pawl 222, Fig 4).
Mahoney further teaches the driving wheel (gear 214) stops rotating when the driving end (end of pawl 222) is sliding on a surface of the wheel teeth (surface of teeth of gear 214) ([0080]: “The moveable pawl 222 and the teeth of the gear 214 are also shaped such that linear movement of the moveable pawl 222 in a second direction past the gear 214, as shown by arrow "B" in FIG. 4, causes no rotation of the gear 214 (i.e., the moveable pawl and the teeth are shaped to slide over each other as the moveable pawl 222 moves past the gear 214 in the second direction)”).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Dilanni/Gross with the teaching of teeth shape of Mahoney to allow the driving end to slide on the second direction without movement of the wheel ([0080]).
Dilanni/Gross/Mahoney are silent wherein the position limited member is configured to increase a frictional force that the driving wheel receives when rotating, ensuring that the driving wheel stops rotating when the driving end slides on the surface of the wheel teeth.
Gorman teaches a position limited member (pawl 110, Fig 7A), wherein the position limited member (110) is movably assembled on the base (pawl 110 is assembled on the base of housing 54, Fig 7) to limit a position of the driving wheel (gear 42, Fig 7A), and the position limited member (110) and the driving wheel (42) are frictional fit (Fig 7A shows the pawl 110 in frictional contact with the wheel 42). Gorman further teaches wherein the position limited member (pawl 110, Fig 7A) is configured to increase a frictional force that the driving wheel (gear 42, Fig 7A) receives when rotating ensuring that the driving wheel (42) stops rotating (Col 12, line 62- Col 13, line 4).
Dilanni/Gross/Mahoney/Gorman discloses wherein the position limited member (110, from Gorman) is configured to increase a frictional force that the driving wheel (256, from Dilanni) receives when rotating, ensuring that the driving wheel (256, from Dilanni) stops rotating when the driving end slides on the surface of the wheel teeth (264, from Dilanni).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dilanni/Gross/Mahoney with similar position limiting members as taught by Gorman for the purpose of allowing rotation of the gear in a single direction (Col 12, line 62- Col 13, line 4).
Regarding Claim 3, Dilanni/Gross/Mahoney/Gorman discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 1. Dilanni discloses wherein the linear actuator includes an electrically driven linear actuator (260a) or an electrically heated linear actuator ([0038]).
Regarding Claim 4 Dilanni/Gross/Mahoney/Gorman discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 1. Dilanni discloses wherein the reset unit includes an electrically driven linear actuator, an electrically heated linear actuator (SMA wire 260b is an electrically driven linear actuator, an electrically heated linear actuator) or an elastic member ([0038]: actuator 260a and 260b are being energized in an alternating way, SMA are well known in the art, heating as result of being energized is a key part of its functionality to induce a shape change; since the SMA change shape under specific conditions can be considered an elastic member).
Gross teaches wherein the reset unit includes an elastic member (return spring 29, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dilanni/Gross/Mahoney/Gorman with similar reset spring as taught by Gross for the purpose of move the driving part in the opposite direction related to the direction of movement of the actuator to reset the system by completing one reciprocation ([0096]).
Regarding claim 5, Dilanni/Gross/Mahoney/Gorman discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 4. Dilanni discloses wherein the reset unit is an elastic conductive member ([0038]; since the SMA change shape under specific conditions can be considered an elastic member).
Gross teaches a wherein the elastic member (return spring 29, Fig 1) is conductive ([0040] spring is made of metal which is conductive).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the material of spring of device of Dilanni/Gross/Mahoney/Gorman with a similar metal material as taught by Gross for the purpose of achieving higher tolerances at relatively low cost ([0040]).
Regarding Claim 6, Dilanni/Gross/Mahoney/Gorman the unilaterally driven drug infusion device with multiple infusion modes of claim 5. Dilanni is silent wherein the elastic conductive member includes a metal spring.
Gross teaches a wherein the elastic conductive member (return spring 29, Fig 1) includes a metal spring ([0040] spring is made of metal which is conductive).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the material of spring of device of Dilanni/Gross/Mahoney/Gorman with a similar metal material as taught by Gross for the purpose of achieving higher tolerances at relatively low cost ([0040]).
Regarding claim 7, Dilanni/Gross/Mahoney/Gorman discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 1. Dilanni discloses the drug infusion device further comprising at least one blocking wall (contact point 164b, Fig 4), wherein when the driving member (262) is in contact with the blocking wall (164a), the driving member stops rotating ([0035]; [0038]: 262 contacts 164b or 164a and stops rotating in one direction).
Regarding claim 10, Dilanni/Gross/Mahoney/Gorman discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 1. Dilanni discloses wherein the variety of different operating modes of the driving member include different amplitude ([0040]: The total distance traveled by each rotational movement actuated by SMA wire 260a in the first direction 20 of the driving unit, which also represents the distance the piston is being moved. SMA wire 260b will contribute to resetting because only one arm 264 is present. The total distance or amplitude traveled differs based on desired injection amount and therefore different infusion mode) or frequency of reciprocating movement, or include various different movement rates
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-7, and 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant submits that amended limitation of claim 1, "the control unit is configured to control a magnitude of a force output of the linear actuator to make the driving member have the different rotation amplitudes, and each of the different rotation amplitudes corresponds with a respective infusion increment" is not disclosed by the prior art.
Examiner respectfully disagrees.
Dilanni discloses a control unit (control circuitry, not shown; [0038]) that controls the SMA actuators which includes the magnitude of the force output at time of actuation. The phrase “rotational amplitudes” is interpreted as the total rotation, which differs based on the quantity of medication desired to inject. The total rotation represents the sum of each rotational movement actuated by SMA wire 260a in the first direction 20 of the driving unit, which also represents the distance the piston is being moved. The total rotation differs based on desired injection amount and therefore different infusion mode. Claim limitations do not limit the magnitude of the controlled force to be variable, or the relationship where each magnitude represents a different amplitude of a single rotational movement. Additionally, it is noted that the scope of what constitutes a mode is not limited to a singular rotational movement.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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