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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5th 2026 has been entered.
Claim Objections
Claim 4 is objected to because of the following informalities:
Regarding claim 4, “a first direction” should be corrected to “the first direction” and “a second direction” should be corrected to “the second direction” for claim language consistency. Appropriate correction is required.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni (US 20050238507 A1), in view of Mahoney (US 20030199824 A1), and further in view of Preuthun (US 20070104596 A1).
Regarding claims 1-2, Dilanni discloses a drug injection device (fluid delivery device 200, [0004] and [0028] & Fig. 1) comprising: a pump module including a shaft configured to perform a linear reciprocating motion in one direction (the linear actuator for driving wheel 256 is being interpreted as the pump module, [0034] & Fig. 2 and 4-5; wire portions 260a and 260b, which are being interpreted as the shaft, are configured to reciprocate in one direction, [0038]-[0039] & Fig. 5; the Examiner notes the wire portions may be interpreted as a continuous SMA wire or two separate pieces of wire connected to member 262, see [0034]);
a rotary part including a second end connected to the shaft (pivotable drive engaging member 262 having a second end coupled to wires 260a and 260b, [0034] & Fig. 2 and 4-5), a first end configured to rotate and reciprocate according to the linear reciprocating motion of the shaft (legs 268a and 268b, which are being interpreted as the first end, are configured to rotate and reciprocate according to the linear reciprocating motion of the linear actuator, see [0038]-[0039] & Fig. 5; the Examiner notes that member 262 may only include one leg, see [0036]);
a first sensor and a second sensor (contact point 164a is being interpreted as the first sensor and contact point 164b is being interpreted as the second sensor, [0036]-[0037] & Fig. 4-5) configured to obtain first contact time information about when the first sensor and the first end come into contact with each other, and second contact time information, about when the second sensor and the first end come into contact with each other (“the contact points 164a, 164b electrically connect the pivotable drive engaging member 262 to actuator conductive paths 196a, 196b.”; “leg 268a contacts the contact point 164a, electrically connecting the pivotable drive engaging member 262 to the conductive path 196a (shown in FIG. 4). This activates a signal to the control circuitry (not shown) via the conductive path 196a indicating that the control circuitry should disable the current being applied to the second SMA wire portion 260b.”, see [0039], and “leg 268b contacts the contact point 164b, electrically connecting the pivotable drive engaging member 262 to the conductive path 196b (shown in FIG. 4)”, see [0038]; the signal sent to the control circuitry when point 164a and leg 268a connect is being interpreted as the first contact time information and the signal sent to the control circuitry when point 164b and leg 268b connect is being interpreted as the second contact time information, both signals communicate to the control circuity a time when the contact points comes into contact with legs 268a and 268b);
a driving unit including the rotary part and the at least one sensor (fluid driving mechanism 250 is being interpreted as the driving unit, which is being interpreted as including member 262 and contact points 164a and 164b, [0036]-[0037] & Fig. 4); and
a controller (control circuitry, [0037]), and wherein
first end is configured to perform a first rotary motion in a first direction until coming into contact with the first sensor (leg 268a, which is part of the first end, moves in a first rotary motion in a first direction 20 until contacting contact 164a, [0039] & Fig. 5), and the first end is further configured to perform a second rotary motion in a second direction opposite to the first direction until coming into contact with the second sensor (leg 268b, which is part of the first end, moves in a second rotary motion in a second direction 22 opposite first direction 20 until contacting contact 164b, [0038] & Fig. 5).
Dilanni discloses “[t]he control circuitry alternates energizing the SMA wire portions 260a, 260b until a desired amount of fluid has been dispensed” ([0040]).
However, Dilanni fails to explicitly disclose a controller configured to determine a driving time of the pump module based on the contact time information and determine an additional driving time of the pump module based on the driving time, wherein the driving time is a time for driving a push operation and a pull operation of the pump module, and
wherein the controller is further configured to determine a first driving time and a second driving time of the pump module based on first contact time information and second contact time information.
However, Mahoney teaches a drug injection device 10 (see abstract and [0057] & Fig. 2) comprising a shape memory element 220 configured to linearly reciprocate and cause rotation of a gear 214, which subsequently advances a piston 204 to dispense fluid (see [0080] and [0082] & Fig. 3-4). Mahoney further teaches a controller (processor 50, [0084]) configured to determine a driving time of the pump module (processor 50 configured to determine how many charges an hour to deliver to element 220 based on received data from user, [0084]; the determination of “charges an hour” is being interpreted as determining a driving time) and determine an additional driving time of the pump module based on the driving time (“Various flow rates are achieved by adjusting the time between charges”, [0084]; processor 50 adjusting the time between charges delivered to element 220 is being interpreted as determining an additional driving time), and wherein the driving time is a time for driving a push operation and a pull operation of the pump module (the charges per hour delivered to element 220 dictates the time for driving a push and pull operation of element 220, [0082] and [0084]; charge delivery to element 220 increases and decreases its length in a reciprocating, push and pull, fashion, see [0081]-[0082] & Fig. 4)
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the controller of Dilanni with Mahoney to include the controller configured to determine a driving time of the pump and determine an additional driving time of the pump module based on the driving time, and wherein the driving time is a time for driving a push operation and a pull operation of the pump module, since such a modification would allow for the controller to not only alternate energizing the SMA wire portions 260a, 260b until a desired amount of fluid has been dispensed, as disclosed in Dilanni in [0040], but also control the flow rate over a predetermined period of time (see [0084] of Mahoney).
Further, Preuthun teaches a controller (controller 580, Fig. 11) configured to determine a driving time of the pump module based on the contact time information (see [0027]-[0028]; “a controller for determining on the basis of the supplied signals the time lapsed when the actuator member is moved between the first and second positions in a given direction”, see claim 8), and wherein the controller is further configured to determine a first driving time and a second driving time of the pump module (see [0027] and see [0033]; the time lapsed is being interpreted as the driving time which is based on the first position, when rod 137 is in contact with contact 128, and a second position, when rod 137 is in contact with contact 129, [0067] and [0069] & Fig. 2A and 2C; the first driving time being when rod 137 moves from the first position to the second, and the second driving time being when rod 137 moves from the second position to the first position) based on first contact time information about when the first sensor and the second end come into contact with each other (the time signals sent to the controller indicating elapsed time between the second position and the first position is being interpreted as the first contact time information, [0040] and [0095]; seen in Figure 2A when rod 137 contacts first sensor 128, [0067]) and second contact time information about when the second sensor and the second end come into contact with each other (the time signals sent to the controller indicating elapsed time between the first position and the second position is being interpreted as the second contact time information, [0040] and [0095]; seen in Figure 2C when rod 137 contacts second sensor 129, [0069]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the controller of Dilanni, as modified with Mahoney, with Preuthun to include the controller configured to determine a driving time of the pump module based on the contact time information, and to determine a first driving time and a second driving time of the pump module based on first contact time information and second contact time information, since such a modification would provide a consistent means of determining the time elapsed between reciprocating action of the actuator to aid in determining normal pump operation (see [0027] and [0037] of Preuthun). Preuthun teaches employing two electrical contact members between a rotating and reciprocating end of a rotary part, structure synonymous to member 262 and contacts 164a/164b of Dilanni, to be an art effective configuration for measure the driving time of a pump module.
Regarding claim 3, Dilanni, as modified, discloses all the limitations of claim 2. As modified, Dilanni further discloses the drug injection device wherein the controller is further configured to determine whether to apply the additional driving time based on the first driving time or the second driving time (as modified, the control circuitry would be configured to adjust the time between charges based on the first or second driving time signaled by the contact points 164a and 164b connecting with legs 248a and 248b, which would indicate the current flow rate and amount of fluid being dispensed, [0040] & Fig. 4-5 of Dilanni and [0083]-[0084] of Mahoney), and to control the pump module to perform the linear reciprocating motion in response to the additional driving time (as modified, the control circuity would be configured to alternate energizing the SMA wire portions 260a, 260b until a desired amount of fluid has been dispensed at a desired flow rate, see [0040] of Dilanni and [0084] of Mahoney; alternate energizing of the SMA wire portions 260a and 260b creating the linear reciprocating motion, [0038]-[0039] & Fig. 5).
Regarding claim 4, Dilanni, as modified, discloses all the limitations of claim 1. Dilanni further discloses the drug injection device wherein the shaft reciprocates in a first direction from a first space toward a second space and in a second direction opposite to the first direction (as wire portion 260a contracts, it moves in a first direction, indicated by arrow 20, from a space between crimp terminations 266a and 266b to a space near post 161a, [0034]-[0035] and [0038] & Fig. 5; once portion 260a is deenergized, it expands, moving in a second direction indicated by arrow 22 back to its original position, [0038]-[0039]), wherein the first space and the second space are divided from each other by a membrane located inside the pump module (crimp termination 266a is being interpreted as the membrane located inside the pump module, [0035]; crimp 266a seen in Fig. 4-5 dividing the first space and the second space), and wherein a space farther from the shaft with respect to the membrane is the first space, and a space closer to the shaft is the second space (the space between crimp terminations 266a and 266b, the first space, is farther from wire portion 260a with respect to crimp 266a than the space near post 161a, the second space, see Fig. 4 and annotated Fig. 5 below wherein the first space is annotated as “1stt” and the second space is annotated as “2nd”; wire 260a is immediately adjacent to the second space while there is a gap between the end of wire 260a terminating in crimp 266a and the first space with respect to crimp 266a).
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Regarding claim 5, Dilanni discloses a method of driving a drug injection device (delivery device 200 for passing fluid to a destination, [0029] and see [0004] & Fig. 1), the method comprising: driving a pump of a pump module including a shaft, thereby causing the shaft to perform a linear reciprocating motion in one direction (the linear actuator for driving wheel 256 is being interpreted as the pump module, [0034] & Fig. 2 and 4-5; wire portions 260a and 260b, which are being interpreted as the shaft, are configured to reciprocate in one direction, [0038]-[0039] & Fig. 5; the Examiner notes the wire portions may be interpreted as a continuous SMA wire or two separate pieces of wire connected to member 262, see [0034]);
obtaining contact time information by using a rotary part and a first sensor and a second sensor (pivotable drive engaging member 262 is being interpreted as the rotary part, [0036] & Fig. 2 and 4-5; contact points 164a and 164b are being interpreted as the first and second sensors, [0037] & Fig. 4-5; signals sent to the control circuitry when point 164a or 164b connect to legs 258a/258b of member 262 is being interpreted as contact time information, signals communicate to the control circuity a time when the contact points comes into contact with legs 268a/268b, [0037]-[0039] & Fig. 5), the rotary part including a second end connected to the shaft (pivotable drive engaging member 262 having a second end coupled to wires 260a and 260b, [0034] & Fig. 2 and 4-5) and a first end which rotates and reciprocates according to the linear reciprocating motion of the shaft (legs 268a and 268b, which are being interpreted as the first end, are configured to rotate and reciprocate according to the linear reciprocating motion of the linear actuator, see [0038]-[0039] & Fig. 5; the Examiner notes that member 262 may only include one leg, see [0036]),
wherein the contact time information comprises information about when the first sensor and the second sensor come into contact with the first end (“the contact points 164a, 164b electrically connect the pivotable drive engaging member 262 to actuator conductive paths 196a, 196b.”, [0037]; “leg 268a contacts the contact point 164a, electrically connecting the pivotable drive engaging member 262 to the conductive path 196a (shown in FIG. 4). This activates a signal to the control circuitry (not shown) via the conductive path 196a indicating that the control circuitry should disable the current being applied to the second SMA wire portion 260b.”, see [0039], and “leg 268b contacts the contact point 164b, electrically connecting the pivotable drive engaging member 262 to the conductive path 196b (shown in FIG. 4)”, see [0038]; the signal sent to the control circuitry when point 164a or 164b connect to legs 258a/258b is being interpreted as the contact time information, signals communicate to the control circuity a time when the contact points comes into contact with legs 268a/268b), and
wherein the first end is configured to perform a first rotary motion in a first direction until coming into contact with the first sensor (leg 268a, which is part of the first end, moves in a first rotary motion in a first direction 22 until contacting contact 164a, [0039] & Fig. 5), and the first end is further configured to perform a second rotary motion in a second direction opposite to the first direction until coming into contact with the second sensor (leg 268b, which is part of the first end, moves in a second rotary motion in a second direction 20 opposite first direction 22 until contacting contact 164a, [0038] & Fig. 5).
However, Dilanni fails to explicitly disclose the method comprising: determining a driving time of the pump module based on the contact time information, and determining an additional driving time of the pump module based on the driving time, wherein the driving time is a time for driving a push operation and a pull operation of the pump module.
However, Mahoney teaches a method of driving a drug injection device 10 (see abstract, [0003], and [0057] & Fig. 2) comprising a shape memory element 220 configured to linearly reciprocate and cause rotation of a gear 214, which subsequently advances a piston 204 to dispense fluid (see [0080] and [0082] & Fig. 3-4).
Mahoney further teaches a method of driving a drug injection device 10 (see abstract, [0003], and [0057] & Fig. 2) comprising: determining a driving time of the pump module (processor 50 configured to determine how many charges an hour to deliver to element 220 based on received data from user, [0084]; the determination of “charges an hour” is being interpreted as determining a driving time), and determining an additional driving time of the pump module based on the driving time (“Various flow rates are achieved by adjusting the time between charges”, [0084]; processor 50 adjusting the time between charges delivered to element 220 is being interpreted as determining an additional driving time), wherein the driving time is a time for driving a push operation and a pull operation of the pump module (the charges per hour delivered to element 220 dictates the time for driving a push and pull operation of element 220, [0082] and [0084]; charge delivery to element 220 increases and decreases its length in a reciprocating, push and pull, fashion, see [0081]-[0082] & Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Dilanni with Mahoney to include determining a driving time of the pump module, and determining an additional driving time of the pump module based on the driving time, wherein the driving time is a time for driving a push operation and a pull operation of the pump module, since such a modification would allow for the controller to not only alternate energizing the SMA wire portions 260a, 260b until a desired amount of fluid has been dispensed, as disclosed in Dilanni in [0040], but also control the flow rate over predetermined period of time (see [0084] of Mahoney).
Further, Preuthun teaches a method of driving a drug injection device ([0040)) comprising: determining a driving time of the pump module based on the contact time information (“a controller for determining on the basis of the supplied signals the time lapsed when the actuator member is moved between the first and second positions in a given direction”, see claim 8 & Fig. 11; the time lapsed is being interpreted as the driving time which is based on the first position, when rod 137 is in contact with contact 128, and a second position, when rod 137 is in contact with contact 129, [0067] and [0069] & Fig. 2A and 2C; see [0027]-[0028]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Dilanni, as modified with Mahoney, with Preuthun to include determining a driving time of the pump module based on the contact time information since such a modification would provide a consistent means of determining the time lapsed between reciprocating action of the actuator to aid in determining normal pump operation (see [0027] and [0037] of Preuthun). Preuthun teaches employing two electrical contact members between a rotating and reciprocating end of a rotary part to be an art effective configuration for measure the driving time of a pump module.
Regarding claim 6, Dilanni, as modified, discloses a non-transitory computer-readable recording medium having recorded thereon a program for executing the method of driving the drug injection device of claim 5 (control board 290 and control circuitry for controlling the device, [0029]; the control circuity, as modified, controls the method of driving the drug injection device of claim 5 above; the control circuity, as modified, controls the energization of wire portions 260a and 260b to drive drug delivery at a desired flow rate over a period of time, see [0038]-[0039] of Dilanni and the rejection of claim 5 above).
Regarding claim 7, Dilanni, as modified, discloses all the limitations of claim 1. Dilanni further discloses the drug injection device wherein the rotary part further comprises two third ends in contact with a first connection end and a second connection end respectively (arms 264a and 264b are being interpreted as the two third ends, [0036] & Fig. 2 and 4-5; arms 264a and 264b in contact with teeth on rachet wheel portions 258a and 258b), and
moving in predetermined directions to apply a force to a gear of the first connection end or a gear of the second connection end, thereby rotating the driving unit (arms 264a and 264b engage teeth on rachet wheel portions 258a and 258b to incrementally rotate drive wheel 256, which “threadably engages and imparts linear motion to the threaded drive rod 252 to advance the plunger 236 into the reservoir 230, thereby forcing fluid out of the reservoir 230”, see [0032], [0036], and [0038]-[0039] and [0052] & Fig. 2 and 4-5).
Regarding claim 8, Dilanni, as modified, discloses all the limitations of claim 5. Dilanni further discloses the drug injection device wherein the rotary part further comprises two third ends respectively in contact with a first connection end and a second connection end (arms 264a and 264b are being interpreted as the two third ends, [0036] & Fig. 2 and 4-5; arms 264a and 264b in contact with teeth on rachet wheel portions 258a and 258b), and
wherein the method further comprises moving the two third ends in predetermined directions to apply a force to a gear of the first connection end or a gear of the second connection end, thereby rotating a driving unit including the rotary part, the first sensor, and the second sensor (arms 264a and 264b engage teeth on rachet wheel portions 258a and 258b to incrementally rotate drive wheel 256, which “threadably engages and imparts linear motion to the threaded drive rod 252 to advance the plunger 236 into the reservoir 230, thereby forcing fluid out of the reservoir 230”, see [0032], [0036], and [0038]-[0039] and [0052] & Fig. 2 and 4-5; fluid driving mechanism 250 is being interpreted as the driving unit, which is being interpreted as including member 262 and contact points 164a and 164b, Fig. 4).
Response to Arguments
Applicant’s arguments with respect to the claims 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. The new limitations are found to be taught by Dilanni as rejected above. Member 262 pivots around point 162 which is considered a rotation. Legs 268a and 268b pivot/rotate such that they contact sensing points 164a and 164b.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yang (US 20190117881 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783