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 Objections
Claims 8-9 are objected to because of the following informalities:
Claim 8 refers to “a first speed Si during the first phase P1” and “a second speed S2 during the second phase P2”. However, claim 1 already introduced “a first speed during a first phase P1” and “a second speed during a second phase P2”. Assuming claim 8 refers to the same two speeds introduced in claim 1, the applicant should amend claim 8 to say “[[a]] the first speed, defined as S1[,] during the first phase P1” and “[[a]] the second speed, defined as S2[,] during a second phase P2” or something similar.
Claim 9 is objected to as it depends from claim 8.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 10, 13, 24 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticiapted by Siposs et al. (US 4,435,173), hereafter “Siposs”.
As to claim 1, Siposs discloses a drug delivery device (10; see Figs. 1-3) comprising:
a housing (12) configured to receive a container (14) containing a volume of medicament (see para beginning line 67 col. 3);
an actuator (78) configured to initiate a drug delivery procedure (para beginning line 35 col. 5); and
a drive system comprising:
an axial drive component (nut 36) configured to drive advancement of a stopper (plunger 18, depicted with a stopper on right side thereof in Fig. 1) sealing the container (Fig. 1, para beginning line 24 col. 4);
a variable rate drive configured to drive advancement of the axial drive component, wherein the variable rate drive comprises a motor (28, 32, 34) configured to drive the axial drive component (rotation of lead screw causes movement of nut 36; para beginning line 24 col. 4); and
a controller (motor drive logic 64 and associated electrical components) configured to:
a. drive the variable rate drive at a first speed (“high rate”, which is faster than base rate – see lines 37-46 col. 7, para beginning line 35 col. 5) during a first phase P1 to deliver a first predefined volume V1 of medicament from the container at a first rate R1 (see para beginning line 56 col. 4, para beginning line 35 col. 5);
b. identify an end point for the first phase P1 by identifying completion of a predetermined number of motor rotations (see para beginning line 49 col. 4, para beginning line 35 col. 5); and
c. drive the variable rate drive at a second speed during a second phase P2 to deliver a second predefined volume V2 of medicament from the container at a second rate R2 (“base rate” – see para beginning line 10 col. 3 and line 56 col. 4 through line 34 col. 5; the examiner notes that a “predefined volume” does not necessarily need to be one programmed by a user before a procedure begins but could encompass values calculated by the device or limited by physical constraints of the device),
wherein-the first rate R1 is different from the second rate R2 (lines 5-9 and lines 45-48 col. 3).
As to claim 2, Siposs discloses the drug delivery device according to claim 1, wherein the controller is further configured to identify a start point for delivery of medicament from the container, wherein the start point is identified by identifying completion of a predetermined preparatory event (in this instance the predetermined preparatory even can be interpreted as any of a variety of events, such activation of limit switch 42, or pressing of bolus start button 78 and/or switch 88), and wherein the first phase P1 begins at the start point (see para beginning line 35 col. 5, and para beginning line 66 col. 5; P1 can begin after any of the above mentioned preparatory events).
As to claim 3, Siposs discloses drug delivery device according to claim 1, wherein the drive system comprises a telescopic screw assembly (32, 36; see Fig. 1, para beginning line 24 col. 4).
As to claim 4, Siposs discloses the drug delivery device according to claim 1, wherein the motor is a pulse width modulation (PWM) driven motor (line 56 col. 3 through line 26 col. 5).
As to claim 5, Siposs discloses the drug delivery device according to claim 2, wherein the predetermined preparatory event is one of: completion of a predetermined distance travelled by the axial drive component (as noted above; one possible interpretation of a predetermined preparatory event is activation of limit switch 42, which corresponds to the axial drive component traveling to a predetermined maximum distance of travel).
As to claim 8, Siposs discloses the drug delivery device according to claim 2, wherein the controller is configured to control the variable rate drive to run at: a preparatory speed (speed during refilling of a syringe) during a preparatory phase PO (interpreted as a refilling phase – i.e. see para beginning line 66 col. 5) until completion of the predetermined preparation event (upon refilling and reaching the syringe, it is possible for the bolus start button 78 to be pressed); a first speed Si during the first phase P1; and a second speed S2 during the second phase P2 (see rejection of claim 1 above).
As to claim 10, Siposs discloses the drug delivery device according to claim 1, wherein a medicament delivery period (TD) is defined as a first time (TP1) taken to complete the first phase P1 and a second time (TP2) time taken to complete the second phase P2 (this claim does not further limit the structure or programming of the device and merely recites an abstract idea of mathematically defining a delivery period).
As to claim 13, Siposs discloses a method for controlling a drive system for a drug delivery device (10; see Figs. 1-3), wherein the drive system comprises: an axial drive component (nut 36) configured to drive advancement of a stopper (plunger 18, depicted with a stopper on right side thereof in Fig. 1) sealing a container (14); a variable rate drive configured to drive advancement of the axial drive component, wherein the variable rate drive comprises a motor (28, 32, 34) configured to drive the axial drive component (rotation of lead screw causes movement of nut 36; para beginning line 24 col. 4); and a controller (motor drive logic 64 and associated electrical components) configured to drive the variable rate drive, the method comprising:
a. driving the variable rate drive at a first speed S1 during a first phase P1 to advance the axial drive component a first axial distance at a first rate R1 (high/bolus rate - see para beginning line 32 col. 2, para beginning line 35 col. 5, lines 37-46 col. 7; the lead screw is driven at a higher rate to deliver boluses);
b. identify-identifying an end point for the first phase P1 by identifying completion of a predetermined number of motor rotations (see para beginning line 49 col. 4, para beginning line 35 col. 5); and
C. driving the variable rate drive at a second speed S2 during a second phase P2 to drive the axial drive component a second axial distance at a second rate R2 (“base rate” – see para beginning line 10 col. 3 and line 56 col. 4 through line 34 col. 5),
wherein the first speed S1 is different from the second speed S2 (lines 5-9 and lines 45-48 col. 3).
As to claim 24, Siposs discloses the drug delivery device of claim 1, wherein the second rate R2 is less than the first rate R1 (lines 5-9 and lines 45-48 col. 3).
As to claim 25, Siposs discloses the method according to claim 13, wherein the second rate R2 is less than the first rate R1 (lines 5-9 and lines 45-48 col. 3).
.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siposs in view of Crankshaw et al. (US 4,741,732).
As to claim 6, Siposs discloses the drug delivery device according to claim 1 as described above, but is silent to wherein the drive system comprises an optical encoder to monitor the speed of the motor and provide feedback to the controller.
Crankshaw teaches “An optical encoder 127, which forms part of the motor monitors the speed of the motor and feeds this data to the micro processor 120 so that the speed of the motor is accurately controlled by the micro processor 120” (see line 57 col. 9 through line 20 col. 10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Siposs to include an optical encoder to monitor the speed of the motor and provide feedback to the controller. One would have been motivated to do so as an additional/alternative way of monitoring the motor of Siposs so that the motor could be more accurately controlled (see para beginning line 57 col. 9 of Crankshaw).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siposs in view of Crankshaw as applied to claim 6 above, and further in view of Shipp (US 2002/0151837 A1).
As to claim 7, Siposs in view of Crankshaw teaches the drug delivery device according to claim 6, but is silent to wherein the controller is configured to adjust power supplied to the motor in response to the feedback from the optical encoder.
Shipp discloses a controller can vary an amount of power supplied to a motor to maintain/change a range of delivery based on sensor feedback (see para 0019, 0052, 0055, claim 8, claim 19).
One having ordinary skill in the art, well aware that modifying an amount of power delivered to a motor can alter a rate of delivery, would have found it obvious to have modified Ledford further (as already modified above) such that the controller is configured to adjust power supplied to the motor in response to the feedback from the optical encoder. One would have been motivated to do so in order to ensure a proper amount of fluid is being delivered for the procedure at hand (see para 0019, 0052, 0055, claim 8 of Shipp).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siposs in view of Smith et al. (US 2012/0078181 A1), hereafter “Smith”.
As to claim 11, Siposs discloses the drug delivery device according to claim 1 as described above, but does not expressly recite wherein the controller is further configured to drive the variable rate drive to deliver a third predefined volume V3 of medicament from the container at a third rate R3, and wherein the controller is further configured to: a. identify an end point for the second phase P2; and b. drive the variable rate drive at a third speed during a third phase P3 to deliver the third volume V3 of medicament from the container at the third rate R3.
Smith teaches “Whether configured as a "pocket pump" or a "patch pump," the system may be configured to provide basal delivery of medicament in accordance with a delivery profile provided by a physician by way of a clinician's programming unit. For example, the system may include a program that stores a number of delivery profiles (e.g. delivery profiles associated a 24-hour delivery cycle and delivery profiles for particular situations such as sleep or illness). Each delivery profile specifies multiple doses (or pump "operations") over time, e.g. a particular number of doses at particular times or a particular number of doses per unit time. In some implementations, a dose may be the volume associated with the minimum controllable displacement of a cartridge plunger” (para 0225) and “The delivery operation may follow a predetermined delivery profile (e.g. a particular basal rate, a series of time-spaced bolus deliveries, or some combination thereof) that is equated to motor rotations, at particular rates and times, required to deliver medicament in accordance with the profile. The profile may be input by the user with the remote control 1000 and stored by the controller 240. For example, as described below, the remote control may store a number of different delivery profiles and bolus deliveries from which the patient can choose. Such profiles may correspond to, for example and depending on the medicament, days where vigorous exercise is expected, days where it is not, incidences of increased pain, etc.” (para 0453).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith such that the controller is further configured to drive the variable rate drive to deliver a third predefined volume V3 of medicament from the container at a third rate R3, and wherein the controller is further configured to: a. identify an end point for the second phase P2; and b. drive the variable rate drive at a third speed during a third phase P3 to deliver the third volume V3 of medicament from the container at the third rate R3. One would have been motivated to do so in order to provide a more advanced delivery profile based on a patient’s needs (see para 0225 & 0453 of Smith).
As to claim 12, Siposs discloses the drug delivery device according to claim 1 as described above, but does not expressly recite, wherein the controller is further configured to drive the variable rate drive to deliver a tuple predefined volume Vn of medicament from the container at a tuple rate Rn, and wherein the controller is configured to: a. identify an end point for a phase Pn-1 before a tuple phase Pn; and b. drive the variable rate drive at a tuple speed during the tuple phase Pn to deliver the tuple predefined volume Vn of medicament at the tuple rate Rn.
Smith teaches “Whether configured as a "pocket pump" or a "patch pump," the system may be configured to provide basal delivery of medicament in accordance with a delivery profile provided by a physician by way of a clinician's programming unit. For example, the system may include a program that stores a number of delivery profiles (e.g. delivery profiles associated a 24-hour delivery cycle and delivery profiles for particular situations such as sleep or illness). Each delivery profile specifies multiple doses (or pump "operations") over time, e.g. a particular number of doses at particular times or a particular number of doses per unit time. In some implementations, a dose may be the volume associated with the minimum controllable displacement of a cartridge plunger” (para 0225) and “The delivery operation may follow a predetermined delivery profile (e.g. a particular basal rate, a series of time-spaced bolus deliveries, or some combination thereof) that is equated to motor rotations, at particular rates and times, required to deliver medicament in accordance with the profile. The profile may be input by the user with the remote control 1000 and stored by the controller 240. For example, as described below, the remote control may store a number of different delivery profiles and bolus deliveries from which the patient can choose. Such profiles may correspond to, for example and depending on the medicament, days where vigorous exercise is expected, days where it is not, incidences of increased pain, etc.” (para 0453).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith such that the controller is further configured to drive the variable rate drive to deliver a tuple predefined volume Vn of medicament from the container at a tuple rate Rn, and wherein the controller is configured to: a. identify an end point for a phase Pn-1 before a tuple phase Pn; and b. drive the variable rate drive at a tuple speed during the tuple phase Pn to deliver the tuple predefined volume Vn of medicament at the tuple rate Rn. One would have been motivated to do so in order to provide a more advanced delivery profile based on a patient’s needs (see para 0225 & 0453 of Smith).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ledford (US 20180085520 A1, cited previously) in view of Li (US 20170173260 A1, cited previously).
In regards to claim 13, Ledford discloses a method for controlling a drive system for a drug delivery device (infusion pump system 200, the embodiment in Fig.2 with general embodiments as shown in Fig.1 [0052]), wherein the drive system comprises:
an axial drive component (plunger driver mechanism 170, fig.1, [0052]) configured to drive advancement of a stopper (plunger 140) sealing a container (plunger driver mechanism 170 is actuated to move the plunger 140 of syringe 110 [0052]);
a variable rate drive (driving of the plunger 140 by the pump control system [0052]) configured to drive advancement of the axial drive component, wherein the variable rate drive comprises a motor configured to drive the axial drive component (the motor is capable of driving advancement of the plunger driver mechanism 170 at a variable rate);
and a controller (pump control system 245, Fig.1, [0054]) configured to drive the variable rate drive (pump control system 245 controls operation of a pumping mechanism since the driving of the plunger 140 by the pump control system [0052,0054,0057]), the method comprising:
a. driving the variable rate drive (driving of the plunger 140 by the pump control system [0052]) at a first speed S1 (pump control system 245 controls operation of the pumping mechanism such as the syringe [0054] and speed can be specified [0064], as seen in Fig.6) during a first phase P1 (first phase represented by original infusion 606, Fig.6) to advance the axial drive component a first axial distance at a first rate R1 (as the pump is operation releases fluid, the plunger is advancing in distance in order to force fluid outwardly from the syringe at a specified speed [0052], Fig.6);
b. identifying an end point (infusion interruption point 608, Fig.6) for the first phase P1 (first phase corresponds to original infusion 606, Fig.6);
and c. driving the variable rate (driving of the plunger 140 by the pump control system [0052]) at a second speed S2 (second speed since flow rate over time for restarted infusion 612 is different than original infusion 606 as seen in Fig.6, [0075]) during a second phase P2 (second phase corresponds to restarted infusion 612, Fig.6, [0075]) to drive the axial drive component a second axial distance at a second rate R2 (as the pump is operation to release fluid, the plunger is advancing in distance in order to force fluid outwardly from the syringe at a specified speed [0052], Fig.6), wherein the first speed S1 is different from the second speed S2 (as seen in Fig.6, infusion 606 is at a diff rate than infusion 612, [0075]).
While Ledford discloses of endpoint (infusion interruption point 608, Fig.6) can be specified by a predetermined volume and rate (using the control module, the operator can specify “target delivery time and a rate limit, along with the desired infusion” [0073]), Ledford fails to disclose that endpoint is identified by identifying completion of a predetermined number of motor rotations.
However, Li teaches Li teaches that that endpoint (when infusion stops) is identified by identifying completion of a predetermined number of motor rotations (flow rate can be adjusted by controlling motor’s rotation since motor’s rotation is how exercising control of volume flow rate [0036] so infusion is stopped when motor has been rotated such that there all liquid has passed).
Both Li and Ledford teach of devices for infusion systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endpoint of Ledford to teach that endpoint would be identified after a completion of a predetermined number of motor rotations, as taught by Li. Doing so makes sense because controlling motor’s rotation will help to exercise control over the liquid flow rate [0036].
In regards to claim 14, Ledford discloses of further comprising identifying a start point (beginning of infusion 606 as well as start point 610 when infusion has been restarted, Fig.6) for delivery of medicament from the container (infusion is started and restarted with pump control system recalculates delivery rate for infusate from reservoir 265 as seen in Fig.6) by identifying completion of a predetermined preparatory event (infusion is started after a set target delivery time and rate is inputted [0073]), wherein the first phase P1 (phase is seen as infusion 606, Fig.6) begins from the identified start point (infusion 606 begins at the start of infusion 606 as seen in Fig.6).
In regards to claim 15, Ledford discloses of wherein the predetermined preparatory event (when infusion is started after a set target delivery time and rate is inputted [0073])) is completion of a predetermined distance travelled by the axial drive component (infusion can only be started when the plunger is advancing in distance in order to force fluid outwardly from the syringe at a specified speed [0052]).
In regards to claim 16, Ledford fails to disclose of wherein the predetermined preparatory event is completion of a predetermined number of motor rotations.
However Li teaches of wherein the predetermined preparatory event is completion of a predetermined number of motor rotations (direction and number of turns by the motor controls the degree of extrusion of the infusion tube and controlling over the liquid flow rate and thus, the start point for delivery of medicament from the container happens by identifying completion of the number of motor rotations it takes to extrude into the infusion tube to extract the liquid [0036]).
Both Li and Ledford teach of devices for infusion systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the predetermined preparatory event to be completion of a predetermined number of motor rotations, as taught by Li. Doing so makes sense because controlling motor’s rotation will help to exercise control over the liquid flow rate and signify when infusion can start [0036].
In regards to claim 19, Ledford discloses of further comprising controlling the variable rate drive (controlling of the driving of the plunger 140 by the pump control system [0052]) to run at: a preparatory speed (flush rate [0010], as seen in Fig.4) until completion of the predetermined preparation event (flushing happens until there is a set target delivery time and rate as inputted [0073]); a first speed Si (pump control system 245 controls operation of the pumping mechanism such as the syringe [0054] and speed can be specified [0064], as seen in Fig.4, 6) during the first phase P1 (first phase represented by original infusion 606, Fig.4,6); and a second speed S2 (second speed since flow rate over time for restarted infusion 612 is different than original infusion 606 as seen in Fig.4,6, [0075]) during the second phase P2 (second phase corresponds to restarted infusion 612, Fig.4,6, [0075]).
In regards to claim 20, Ledford discloses of further comprising a. identifying an end point for the second phase P2 (control pump system is able to understand and stop infusion as seen by endpoint 614 in infusion 612, Fig.6); and b. driving the variable rate drive at a third speed S3 during a third phase P3 (control pump system is capable of running at a variable rate a third infusion 618 during infusion 618 [0077], Fig.6) to drive the axial drive component a third axial distance at a third rate R3 (as the pump is operation to release fluid, the plunger is advancing in distance in order to force fluid outwardly from the syringe at a specified speed [0052], Fig.6), wherein the second speed S2 is different from the third speed S3 (as seen in Fig.6, infusion 612 is at a diff rate than infusion 618, [0075]).
In regards to claim 21, Ledford discloses of further comprising: a. identifying an end point for the phase Pn-1 before a tuple phase Pn (control system is capable of identifying when to stop infusion before restarting infusion [0054], Fig.6); and b. driving the variable rate drive (driving of the plunger 140 by the pump control system [0052]) at a tuple speed during a tuple phase Pn (control pump system is capable of running at a variable rate an infusion during the infusion period [0077], Fig.6) to drive the axial drive component a tuple axial distance (as the pump is operation to release fluid, the plunger is advancing in distance in order to force fluid outwardly from the syringe at a specified speed [0052], Fig.6) at a tuple rate (at a rate as seen in Fig.6 and where rate can be specified and changed [0077]), wherein the tuple speed (running at a variable rate an infusion during the infusion period [0077], Fig.6) is different from the speed of the drive during the phase before the tuple phase (speed is different than the phase right before tuple phase changes to start infusion as seen in Fig.6).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ledford (US 20180085520 A1), in view of Li (US 20170173260 A1), and further in view of Shipp (US 2002/0151837 A1).
In regards to claim 18, Ledford discloses of wherein driving the variable rate drive (driving of the plunger 140 by the pump control system [0052]) at the first speed S1 (speed of infusion 606, Fig.6) during the first phase P1 (first phase corresponds to original infusion 606, Fig.6) and driving the variable rate drive (driving of the plunger 140 by the pump control system [0052]) at the second speed S2 (speed of infusion 612, Fig.6) during the second phase P2 (during infusion 612, Fig.6). While Ledford does disclose about varying the speed (operator can specify a target delivery rate [0073] and the restarted infusion rate is recalculated [0075], Fig.6) at the first speed S1 during the first phase P1 (speed of infusion 606 at original infusion 606, Fig.6) and the second speed S2 during the second phase P2 (speed of infusion 612 during infusion 612, as seen in Fig.6), Ledford fails to disclose of varying the power supplied to the motor to maintain the first speed S1 during the first phase P1 and the second speed S2 during the second phase P2.
Shipp discloses a controller can vary an amount of power supplied to a motor to maintain/change a range of delivery (see para 0019, 0052, 0055, claim 8).
One having ordinary skill in the art, well aware that modifying an amount of power delivered to a motor can alter a rate of delivery, would have found it obvious to have modified Ledford further (as already modified above) to include varying the power supplied to the motor to maintain the first speed S1 during the first phase P1 and the second speed S2 during the second phase P2. One would have been motivated to do so in order to ensure a proper amount of fluid is being delivered for the procedure at hand (see para 0019, 0052, 0055, claim 8 of Shipp).
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 9, while Siposs discloses the drug delivery device according to claim 8 as described above, Siposs is silent to wherein the preparatory speed is greater than the first speed S1 and the second speed S2 in combination with the limitations of claims 1, 2, and 8.
Response to Arguments
Applicant’s Remarks submitted 8/15/25 have been considered.
With regard to the arguments concerning the previous claim objections and rejections under 35 U.S.C. § 112, the arguments are persuasive/moot due to the claim amendments. The previous objections and rejections under § 112 have been withdrawn.
With regard to the arguments concerning the previous rejections under 35 U.S.C. § 103, the examiner first points out that the amendments to claim 1 have changed the scope of the claim, and have resulted in the new rejections above. The addition of new claims 24 and 25 has also necessitated new rejections of claims 1 and 13 in order to rejected these new claims. While the applicant’s Remarks are mainly focused on language in claim 1, the examiner will point out several things:
The applicant very narrowly interprets the word “predefined”. The claim does not require a specific time period for when each volume (V1 and/or V2) is defined. For example, the claim does not require that the controller programs each volume before any type of delivery program begins. Even if the second volume V2 is defined is defined immediately before delivery of the second volume, this still falls within the broadest reasonable interpretation of what can be considered “predefined” as long as it is defined before delivery of the volume. The examiner also points out that the claim does not require that the controller does the predefining, and a user selecting a volume by their own adjustment (such as by manual selector knobs 74 and 76 of Siposs) is a form of predefining a volume.
The applicant argues with regard to the Ledford reference that “volumes associated with the infusions 406, 412 are not predefined but instead are random byproducts of the unplanned infusion interruptions” (page 9 of Remarks). The examiner notes that Ledford is only relied upon for the rejection of claim 13 above. However, the examiner disagrees that the volumes are “random byproducts”. The volumes defined by Redford are calculated to complete delivery of a predefined amount of fluid within a timeframe due to an interruption. The volume of restarted infusion 412 is not “random”, it is a recalculated amount (this falling with the scope of a predefined volume, even if that predefining is done immediately before 412). The same can be said regarding Fig. 6 and restarted infusion 612 and 618.
Similar arguments are made regarding Li and the wording of “identifying an end point for the first phase P1 by identifying completion of a predetermined number of motor rotations” (emphasis added by examiner). The examiner points out that the claim is silent to who/what does the identifying, and how the identifying is done (e.g. use of a particular type of sensor or a person visually observing the motor). Li discloses “by controlling the motor's rotation direction and number of turns, the lead screw is controlled to rotate clockwise or counter clockwise by a distance of movement to regulate the degree of extrusion of the infusion tube 102 and exercise control over the liquid flow rate” (para 0036). The examiner maintains that the device of Li must somehow recognize that a certain number of rotations have occurred, otherwise the program of Li would not function to deliver a proper amount of fluid. The examiner recommends making the claim more specific to when and how the number of motor rotations are predetermined, and how the identification of the number of motor rotations is performed.
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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights