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 .
Status of Claims
This office action is responsive to the Pre-Appeal Brief Conference Request filed 6 July 2026.
Claims 9-12 are withdrawn.
Claim 5 is canceled.
Claims 1 and 6 are amended.
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, 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, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US Patent Number 5989222 A), hereinafter Cole in view of O’Brien (US Patent Publication No. 20210275741 A1).
Regarding claim 1, Cole teaches a method of pressure management of a drug delivery device (Cole: Fig. 7, medical infusion system) comprising a pump (Fig. 1a and 7, comprising pump 100 and pump cassette 114), a fluid line (Fig. 1 and 7, proximal tubing 116 and distal tubing 118), a reservoir (IV medicinal liquid supply 172), and a power source (col 7, ln 66 – col 8, ln 1), the method comprising: a) actuating the pump (Fig. 7, pump 100) a predetermined number of cycles to move fluid through the fluid line (Fig. 1 and 7, proximal tubing 116 and distal tubing 118), wherein the predetermined number of cycles is greater than one (two output signals are averaged when the shaft or motor 136 is in the home position, therefore the pump is actuated for two cycles; col 7, ln 41-45 and col 10, ln 1-9); b) determining an estimated pressure value within the fluid line (Fig. 1 and 7, proximal tubing 116 and distal tubing 118) for each cycle of the predetermined number of cycles (output signals are sampled from distal pressure sensor when shaft of motor 136 is in home position; col 10, ln 1-9); and c) determining a baseline pressure level comprising an average of the estimated pressure values (baseline value is calculated by averaging the two previous output signals that were sampled; col 10, ln 1-9).
Cole does not expressly disclose that filling the reservoir with a medicament after a method is performed.
O’Brien teaches a method of pressure management of a drug delivery device (O’Brien: Fig. 1, device 100), comprising filling a reservoir (Fig. 1, fluid storage 120) with a medicament after determining a baseline pressure level (Fig. 5, block 566, motor pressure is predicted based on the current of the motor over multiple cycles, which must occur prior block 572, at which point more fluid is delivered to the fluid delivery tube 106, which leads into the fluid storage 120, thus filling it).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Cole such that it comprised filling the reservoir with a medicament after a method is performed as taught by O’Brien in order to reduce/eliminate unintended boluses, and/or cessation of fluid flow due to changes in fluid pressure (O’Brien: para. 0066).
Regarding claim 3, Cole in view of O’Brien discloses the method above.
Cole does not expressly disclose determining the estimated pressure value comprises measuring a current of a motor during actuation of the pump.
O’Brien teaches determining a pressure value comprises measuring a current of a motor during actuation of the pump (O’Brien: Fig. 5, block 566, motor current can be used to predict motor pressure; para. 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the step of determining the estimated pressure value of Cole such that it comprises measuring a current of a motor during actuation of the pump as taught by O’Brien in order to produce an accurate reading of pressure (O’Brien: para. 0053 and 0060-0061).
Regarding claim 6, Cole in view of O’Brien discloses the method above, further comprising: e) delivering fluid through the fluid line (Cole: Fig. 1 and 7, proximal tubing 116 and distal tubing 118) via the pump (Fig. 7, pump 100); f) determining a delivery pressure value (distal pressure is measured by the distal sensor 176, which senses the delivery stroke pressure; col 8, ln 29-42) within the fluid line (Cole: Fig. 1 and 7, proximal tubing 116 and distal tubing 118); and g) determining whether the delivery pressure value exceeds the baseline pressure level (baseline value is set equal to the averaged distal value, followed by the decision block 260 determining if the value is less than the average distal value and the distal pressure value is greater than the threshold value; col 10, ln 37-61).
Regarding claim 7, Cole in view of O’Brien discloses the method above.
Cole does not expressly disclose determining a delivery pressure value within the fluid line comprises measuring a current of a motor during actuation of the pump.
O’Brien teaches determining a delivery pressure value comprises measuring a current of a motor during actuation of the pump (O’Brien: Fig. 5, block 566, motor current can be used to predict motor pressure; para. 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the step of determining the estimated pressure value of Cole such that it comprises measuring a current of a motor during actuation of the pump as taught by O’Brien in order to produce an accurate reading of pressure (O’Brien: para. 0053 and 0060-0061).
Regarding claim 8, Cole in view of O’Brien discloses the method above, wherein a) through c) are performed using a microcontroller (Cole: Fig. 7, controller 162) comprising at least one processor (Fig. 7, central processing unit 166).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cole in view of O’Brien, in further view of Vanderveen et al (US Patent No. 9039656 B2), hereinafter Vanderveen.
Regarding claim 2, Cole in view of O’Brien discloses the method above.
Cole in view of O’Brien does not expressly disclose a cannula, and wherein the method is performed prior to insertion of the cannula into a patient.
Vanderveen teaches a cannula and a method wherein baseline pressure measurement is performed prior to insertion of the cannula into a patient (Vanderveen: device injects fluid after measuring baseline pressure values; col 5, ln 8-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Cole such that the method is performed prior to insertion of the cannula into a patient as taught by Vanderveen in order to establish baseline pressure before injection (Vanderveen, col 5, ln 8-15).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cole in view of O’Brien, in further view of Moberg et al. (US Patent No. 7892206 B2), hereinafter Moberg, and Wang et al. (US Patent Publication No. 20200205878 A1), hereinafter Wang.
Regarding claim 4, Cole in view of O’Brien discloses the method above, wherein determining baseline pressure level comprises excluding each estimated pressure value that differs by more than a predefined limit from a previous sample (see Cole at claim 17).
Cole in view of O’Brien does not expressly disclose excluding each estimated pressure value where the motor current differs from an average of the measured motor currents of the estimated pressure values by more than 1 mA.
Moberg teaches determining an estimated pressure and excluding each estimated pressure value where the motor current differs from an average of the measured motor currents of the estimated pressure values (Moberg: Fig. 24, block 3010, the average current value is calculated by running a five-point average of the last current readings and discarding the highest and lowest current values, followed by averaging the remaining three values; col 25, ln 66 – col 26, ln 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the step of determining baseline pressure level of Cole in view of O’Brien such that it comprised excluding each estimated pressure value where the motor current differs from an average of the measured motor currents of the estimated pressure values as taught by Moberg in order to remove aberrant signals (col 25, ln 66 – col 26, ln 14).
Cole in view of O’Brien and Moberg does not expressly disclose the difference from an average of the measured motor currents of the estimated pressure values is more than 1 mA.
Wang teaches measuring a motor current average, and excluding each value where the motor current differs from an average of the measured motor currents of the estimated values by more than 1 mA (Wang: pump motor 150 operates within a noise floor of 10-20 mA within the average motor current; para. 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the step of determining baseline pressure level of Cole in view of O’Brien and Moberg such that it excluded each estimated pressure value where the current differs from an average of the measured currents of the estimated pressure values by more than 1 mA as taught by Wang in order to exclude unwanted noise (para. 0060), as values greater than 1 mA and lower than 20-30 mA could have been chosen as an exemplary “low current value” indicative of noise that should be excluded from the average measured currents. Furthermore, the applicant has not disclosed that the excluding values that differ by more than 1 mA solves any stated problem or is critical to the invention.
Response to Arguments
Applicant’s arguments, see page 1-5, filed 6 July 2026, with respect to the rejections of claims 1-4 and 6-8 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Cole in view of O’Brien.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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