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
The amendments filed August 25, 2026, have been entered.
New claims 16 and 17 have been added.
Claims 1-17 are pending.
The rejection of claims 16 and 17 is a new ground necessitated by the amendment adding those claims.
The rejections of claims 1-15 are maintained.
Response to Arguments
Applicant argues on page 8, line 23 – page 10, line 20, in the remarks filed August 25, 2026, regarding claim 1, that Wolff does not disclose an “actuated position” of the holding element because the claimed actuated position is a state in which the piston is not held on the pusher device and the holding element is not in contact with the piston, whereas Wolff’s “activated position” is a state in which anti-siphon arm 17 presses the piston head onto the sensor (Wolff, page 12, line 37 – page 13, line 10). Applicant further argues that the two positions are opposites and that claim 1 therefore requires evaluation of the sensor signal in a no-contact state.
However, Examiner respectfully disagrees, because claim 1, under the broadest reasonable interpretation, does not require that the holding element be out of contact with the piston in the actuated position. Claim 1 recites a holding element movable between (i) a non-actuated position “in which the holding element is configured to hold the piston on the pusher device” and (ii) “an actuated position for installing or releasing the piston from the pusher device.” The phrase “for installing or releasing” states a purpose of that position. It does not recite that the holding element “does not hold” the piston or “is not in contact with the piston.” Those limitations appear for the first time in new claims 16 and 17. Limitations from the specification (application page 15, line 30 - page 16, line 5; Fig. 6) are not read into claim 1. MPEP §2111.01.
Wolff discloses a holding element (anti-siphon arm 17) movable between a non-activated, released position and an activated position in which the arm is used in connection with installing and securing the piston on the pusher device, and a processing device that evaluates a sensor signal in the activated position to determine a value indicative of sensitivity/span drift (Wolff, page 10, lines 24-33; page 12, line 36 – page 13, line 26). That meets claim 1 as written.
Applicant’s own remarks concede that the no-contact construction was in doubt and that claims 16 and 17 were added for that reason (remarks, page 9, lines 17-20). That is consistent with treating claims 16 and 17 as the claims that add the no-contact limitation, not claim 1.
Therefore, the rejection of claim 1 still stands.
Applicant also argues on page 10, lines 22-27, in the remarks filed August 25, 2026, regarding claim 15, that the argument made with respect to claim 1 apply with equal force to claim 15.
However, Examiner respectfully disagrees, because claim 15 likewise does not recite that the holding element does not hold the piston or is not in contact with the piston in the actuated position. That language is in new claim 17. Wolff discloses the method steps of claim 15 for the same reasons set forth in claim 1.
Therefore, the rejection of claim 15 still stands.
Applicant argues on page 11, lines 1-4, in the remarks filed August 25, 2026, that claims 2-14 are allowable because claim 1 is allowable.
However, Examiner disagrees, because claim 1 remains rejected. The dependent claims fall with claim 1 except as separately rejected.
Therefore, the rejections of claims 2-14 still stand.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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.
Claims 1-7 and 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolff (WO Publication No. 2017/207165), hereinafter, Wolff.
Regarding claim 1, Wolff discloses an infusion device (infusion device 1 in fig. 1) for administering a medical fluid to a patient (page 1, lines 20-21), comprising:
a receptacle (receptacle 12 in fig. 1) for receiving a syringe (syringe 2 in fig 2. 1-2; page 8, lines 8-9), the syringe comprising a tube (cylindrical tube 20 in figs. 1-2) and a piston (piston 21 in figs.1-2; page 8, line 9) movable with respect to the tube (piston 21 movable with respect to tube 20; page 8, line 9),
a pusher device (pusher device 11 in figs.1-2) for exerting a force onto the piston for delivering a medical fluid from the tube towards a patient (during operation, infusion device is electromotorically driven in an actuation direction to move piston 21 into cylindrical tube 20 and deliver medical fluid toward the patient B in fig. 1; page 8, lines 16-20),
a sensor device (force sensor 14 in figs. 1-4) arranged on the pusher device for measuring a force exerted on the piston by the pusher device (force sensor 14 is placed on pusher device 11 measuring a force exerted on piston 21; page 9, lines 3-5),
a holding element (anti-siphon arm 17 in figs. 1-2) arranged on the pusher device (pusher device 11 in figs.1-2), the holding element being movable with respect to the pusher device (anti-siphon arm 17 is mounted on pusher device 11 and pivotably mounted on sensor support 18 via shaft 170; page 10, lines 17-21) between a non-actuated position, in which the holding element is configured to hold the piston on the pusher device, and an actuated position for installing or releasing the piston from the pusher device (anti-siphon arm 17 is pivotable from a non-activated position to activated position to act on piston head 210 in fig. 2; page 10, lines 23-28), and
a processing device (processor device 15 in fig. 1) for controlling operation of the infusion device (infusion device 1 is operated by processor device 15; page 8, lines 22-23),
wherein the processing device (processor device 15 in fig. 1) is configured to evaluate a sensor signal measured by the sensor device (force sensor 14 in figs. 1-4) in the actuated position of the holding element (anti-siphon arm 17 in figs. 1-2) and to determine a value indicative of a sensitivity of the sensor device based on said sensor signal measured by the sensor device in the actuated position of the holding element and based on a reference value (second diagnosis routine is performed with anti-siphon arm 17 in the activated position and force sensor 14 produces a signal that is compared to an expected value to detect change in sensitivity, or span drift, and also compares to zero-reference value obtained in first diagnosis routine; page 12, line 8 – page 12, line 26).
Regarding claim 2, Wolff discloses the infusion device according to claim 1, wherein the sensor device (force sensor 14 in figs. 1-4) comprises a sensor support element (sensor support 18 in figs. 2-3) configured to react to a force exerted on the piston by the pusher device (sensor support 18 is elastically deformable in reaction to force exerted on piston head 210 by the pusher device 11 via pressure transmitting element 19; page 11, lines 4-28), wherein the holding element (anti-siphon arm 17 in figs. 1-2) is mounted on the sensor support element and is movable with respect to the sensor support element between the non-actuated position and the actuated position (anti-siphon arm 17 is mounted pivotably mounted via shaft 170 on support member 181, which is connected to sensor support 18 and is pivotable relative to sensor support 18 between non-activated and activated positions; page 10, lines 15-28).
Regarding claim 3, Wolff discloses the infusion device according to claim 2, wherein the sensor device (force sensor 14 in figs. 1-4) comprises at least one sensor element (elements 140 in fig. 4) arranged on the sensor support element (sensor support 18 in figs. 2-3) and configured as a strain gauge or an extension gauge (sensor elements 140 are place on surface of sensor support 18 and are in the shape of strain gauges or extension gauges to form a Wheatstone bridge; page 11, lines 15-28).
Regarding claim 4, Wolff discloses the infusion device according to claim 2, further comprising a spring element (spring element 171 in fig. 2) which is configured to elastically pre-tension the holding element (anti-siphon arm 17 in figs. 1-2) with respect to the sensor support element (sensor support 18 in figs. 2-3) along a direction of motion (shaft 170 is pretensioned with respect to support member 181 via spring element 171 providing a spring-elastic force axially on the shaft; page 10, lines 17-34), wherein the spring element is elastically tensioned when moving the holding element from the non-actuated position to the actuated position (anti-siphon arm 17 exerts force axially onto piston head 210, which is caused by spring element 171, when anti-siphon arm 17 is moved from non-activated to activated position).
Regarding claim 5, Wolff discloses the infusion device according to claim 1, wherein the processing device (processor device 15 in fig. 1) is configured to determine said reference value based on a sensor signal of the sensor device (force sensor 14 in figs. 1-4) in the non-actuated position of the holding element (anti-siphon arm 17 in figs. 1-2; processor device 15 determines the “zero reference” value during first diagnosis routine in the non-activated position; page 12, lines 21-24 and lines 32-34).
Regarding claim 6, Wolff discloses the infusion device according to claim 5. wherein the processing device (processor device 15 in fig. 1) is configured to determine the reference value in a state of the infusion device in which no syringe is connected to the pusher device (pusher device 11 in figs.1-2; device 15 is programmed by software to perform first diagnosis routine wherein sensor device 14 obtains sensor signal when no syringe 2 is arranged on the infusion device 1 such that pusher device 11 is not in operative connections with piston 21 of syringe 2; page 12, lines 8-10).
Regarding claim 7, Wolff discloses the infusion device according to claim 1, wherein the processing device (processor device 15 in fig. 1) is configured to determine said value indicative of the sensitivity of the sensor device based on a difference between said sensor signal measured by the sensor device in the actuated position of the holding element (anti-siphon arm 17 in figs. 1-2) and the reference value (device 15 is programmed by software to perform second routine wherein syringe 2 in placed on infusion device 1 and in operative connection with pusher device 11 in the fully activated position. The sensor signal is measured and compared to an expected sensor signal corresponding to the predefined force, reference value, by which anti-siphon arm 17 presses piston head 210 toward sensor device 14).
Regarding claim 10, Wolff discloses the infusion device according to claim 1, wherein the processing device (processor device 15 in fig. 1) is configured to determine said value indicative of the sensitivity of the sensor device (force sensor 14 in figs. 1-4) based on the following equation:
KS ‘ = (S1 - S0)
where KS ‘ indicates said value indicative of the sensitivity of the sensor device, S1 indicates the sensor signal measured by the sensor device in the actuated position of the holding element, and S0 indicates the reference value (anti-siphon arm 17 in figs. 1-2; device 15 is programmed by software to perform second routine wherein syringe 2 in placed on infusion device 1 and in operative connection with pusher device 11 in the fully activated position (S1). The sensor signal is measured and compared to an expected sensor signal corresponding to the predefined force, reference value (S0), to obtain the value indicative of the sensitivity of the sensor device (KS’); page 12, line 21 – page 12, line 26).
Regarding claim 11, Wolff discloses the infusion device according to claim 1, wherein the processing device (processor device 15 in fig. 1) is configured to determine a default value of the value indicative of the sensitivity of the sensor device (force sensor 14 in figs. 1-4) in a calibration procedure (expected sensor signal may be known from calibration by the force by which anti-siphon arm 17 presses piston head 210 towards sensor device 14 and expected sensor signal can be stored for later reference; page 14, lines 6-9).
Regarding claim 12, Wolff discloses the infusion device according to claim 11, wherein the processing device (processor device 15 in fig. 1) is configured to identify a drift in the sensitivity of the sensor device (force sensor 14 in figs. 1-4) based on a comparison of the default value to a value indicative of the sensitivity of the sensor device determined subsequent to the calibration procedure (process control device 15 may be programmed to carry out second diagnosis routine to detect a span drift of sensor device 14 by comparing obtained sensor signal to the expected sensor signal during second diagnosis routine; page 12, line 36; to increase reliability of second diagnosis routine, measurements can be taken repeated multiple times indicating that comparison takes place before and after calibration; page 14, lines 15-23).
Regarding claim 13, Wolff discloses the infusion device according to claim 1, wherein the holding element (anti-siphon arm 17 in figs. 1-2) is configured, in an operative state in which the holding element is in the non-actuated position and operatively connects the piston to the pusher device (pusher device 11 in figs.1-2), to bias the piston into abutment with the sensor device (force sensor 14 in figs. 1-4; after anti-siphon arm 17 is moved into actuated position to install piston 21, it returns to the non-active position while still operatively connected to piston 21 and pusher device 11; page 10; lines 23-35).
Regarding claim 14, Wolff discloses the infusion device according to claim 13, wherein the processing device (processor device 15 in fig. 1) is configured to determine a load reference value based on a sensor signal of the sensor device in said operative state (processor 15 determines “expected sensor signal” that corresponds to the known constant load, or spring force, applied by anti-siphon arm 17 in the operative state; page 12, line 21 – page 13, line 26).
Regarding claim 15, Wolff discloses a method for operating an infusion device (infusion device 1 in fig. 1) for administering a medical fluid to a patient (page 1, lines 20-21) comprising:
receiving a syringe (syringe 2 in fig 2. 1-2; page 8, lines 8-9) in a receptacle of the infusion device (receptacle 12 in fig. 1), the syringe comprising a tube (cylindrical tube 20 in figs. 1-2) and a piston (piston 21 in figs.1-2; page 8, line 9) movable with respect to the tube (piston 21 movable with respect to tube 20; page 8, line 9),
exerting, using a pusher device (pusher device 11 in figs.1-2), a force onto the piston for delivering a medical fluid from the tube towards a patient (during operation, infusion device is electromotorically driven in an actuation direction to move piston 21 into cylindrical tube 20 and deliver medical fluid toward the patient B in fig. 1; page 8, lines 16-20),
measuring, using a sensor device (force sensor 14 in figs. 1-4) arranged on the pusher device, a force exerted on the piston by the pusher device (force sensor 14 is placed on pusher device 11 measuring a force exerted on piston 21; page 9, lines 3-5), and
controlling operation of the infusion device using a processing device (processor device 15 in fig. 1; infusion device 1 is operated by processor device 15; page 8, lines 22-23),
evaluating, using the processing device (processor device 15 in fig. 1, a sensor signal measured by the sensor device (force sensor 14 in figs. 1-4) in an actuated position of a holding element(anti-siphon arm 17 in figs. 1-2), the holding element being arranged on the pusher device and being movable with respect to the pusher device (anti-siphon arm 17 is mounted on pusher device 11 and pivotably mounted on sensor support 18 via shaft 170; page 10, lines 17-21) between a non-actuated position, in which the holding element is configured to hold the piston on the pusher device, and the actuated position for releasing the piston from the pusher device (anti-siphon arm 17 is pivotable from a non-activated position to activated position to act on piston head 210 in fig. 2; page 10, lines 23-28), and
determining, using the processing device (processor device 15 in fig. 1), a value indicative of a sensitivity of the sensor device (force sensor 14 in figs. 1-4) based on said sensor signal measured by the sensor device in the actuated position of the holding element and based on a reference value (second diagnosis routine is performed with anti-siphon arm 17 in the activated position and force sensor 14 produces a signal that is compared to an expected value to detect change in sensitivity, or span drift, and also compares to zero-reference value obtained in first diagnosis routine; page 12, line 8 – page 12, line 26).
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 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wolff in view of Gillespie (US Patent No. 9,514,518), hereinafter, Gillespie.
Regarding claim 8, Wolff discloses the infusion device according to claim 1, wherein the processing device (processor device 15 in fig. 1) is configured to determine said value indicative of the sensitivity of the sensor device (force sensor 14 in figs. 1-4) based on said sensor signal measured by the sensor device in the actuated position of the holding element (anti-siphon arm 17 in figs. 1-2; device 15 is programmed by software to perform second routine wherein syringe 2 in placed on infusion device 1 and in operative connection with pusher device 11 in the fully activated position. The sensor signal is measured and compared to an expected sensor signal corresponding to the predefined force, reference value, by which anti-siphon arm 17 presses piston head 210 toward sensor device 14; page 12, line 21 – page 13, line 26)
Wolff fails, however, to expressly disclose determining said value indicative of the sensitivity of the sensor device additionally based on a displacement by which the holding element is displaced with respect to the pusher device in the actuated position.
Gillespie teaches determining a sensitivity value based on a displacement by which the holding element is displaced with respect to the pusher device in the actuated position (the linearly movable plunger engagement arm 164 (analogous to the holder element) includes a position sensor 230 that comprises a magnet and a plunger linear sensor array 236. The system uses the measured displacement together with the force sensor signal during calibration and performance monitoring routines; col 12, line 54 – col 13, Line 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify processing device of Wolff to determine the value indicative of the sensitivity of the sensor device in addition based on a displacement (X1) by which the holding element is displaced with respect to the pusher device in the actuated position, as taught by Gillespie, in order to provide a more accurate and reliable calibration of sensor sensitivity by normalizing the change in sensor output to the actual physical displacement of the holding element, thereby improving the detection of span drift in the force sensor used for occlusion monitoring in a syringe infusion pump.
Regarding claim 9, modified Wolff discloses the infusion device according to claim 8, wherein the processing device (processor device 15 in fig. 1) is configured to determine said value indicative of the sensitivity of the sensor device (force sensor 14 in figs. 1-4) in the actuated position of the holding element (anti-siphon arm 17 in figs. 1-2), but Wolff fails to disclose the determination of said value indicative of the sensitivity of the sensor device based on the following equation:
KS = (S1 - S0) / X1
where KS indicates said value indicative of the sensitivity of the sensor device, S1 indicates the sensor signal measured by the sensor device in the actuated position of the holding element, S0 indicates the reference value, and X1 indicates the displacement of the holding element in the actuated position.
Gillespie teaches determination of said value indicative of the sensitivity of the sensor device based on the following equation:
KS = (S1 - S0) / X1
where KS indicates said value indicative of the sensitivity of the sensor device, S1 indicates the sensor signal measured by the sensor device in the actuated position of the holding element, S0 indicates the reference value, and X1 indicates the displacement of the holding element in the actuated position (measures displacement (X1) of the moving plunger engagement arm 164 and combines it with force sensor data during calibration; col 12, line 54 – col 13, Line 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify processing device of Wolff to determine the value indicative of the sensitivity of the sensor device in addition based on the equation:
KS = (S1 - S0) / X1,
as taught by Gillespie, in order to calculate the sensor sensitivity as the normalized change in output signal per unit displacement of the holding element, thereby providing a precise, quantifiable measure of span drift that can be directly compared to a default calibration value for reliable occlusion detection in the infusion device.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wolff in view of (Medfusion®. (2015). Medfusion® Syringe Infusion Pump Model 3000 Series Technical Service Manual. Smiths Medical.), hereinafter, Medfusion.
Regarding claim 16, Wolff discloses the infusion device according to claim 1 comprising the holding element (anti-siphon arm 17 in figs. 1-2) the piston (piston 21 in figs.1-2; page 8, line 9) on the pusher device (pusher device 11 in figs.1-2).
Wolff fails, however, to disclose that the holding element does not hold the piston on the pusher device and is not in contact with the piston in the actuated position.
Medfusion teaches force sensor calibration steps wherein the holding element does not hold the piston on the pusher device and is not in contact with the piston in the actuated position (Medfusion: checking and calibrating a syringe-pump plunger force sensor by first ensuring that no syringe is loaded and confirming a near-zero force reading, page 24, step 1 of Force sensor check and page 91, step 2 of Calibrate force sensor steps; then applying a known force to the plunger driver with a force gauge and comparing the sensor reading to an expected span window, page 24, step 2 of Force sensor check and page 92, step 5 of Calibrate force sensor steps).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the processing device of Wolff to determine the value indicative of sensitivity from the sensor signal taken with the holding element in the released position, in which the holding element does not hold the piston and is not in contact with the piston, as taught by Medfusion, in order to obtain a span/sensitivity reading without uncertain syringe-dimension tolerances in the load path. Wolff already discloses a released, no-piston-contact position of anti-siphon 17 and a processing device that evaluates force-sensor signals for zero and span diagnosis (page 10, lines 24-28, page 12, lines 8-19 and 31-34; page 13, lines 1-26). Medfusion supplies the teaching to take the span/sensitivity measurement with no syringe plunger in the load path
Regarding claim 17, Wolff discloses the method according to claim 15, comprising the holding element (anti-siphon arm 17 in figs. 1-2) and the piston (piston 21 in figs.1-2; page 8, line 9) on the pusher device (pusher device 11 in figs.1-2).
Wolff fails, however, to disclose that the holding element does not hold the piston on the pusher device and is not in contact with the piston in the actuated position.
Medfusion teaches force sensor calibration steps wherein the holding element does not hold the piston on the pusher device and is not in contact with the piston in the actuated position (Medfusion: checking and calibrating a syringe-pump plunger force sensor by first ensuring that no syringe is loaded and confirming a near-zero force reading, page 24, step 1 of Force sensor check and page 91, step 2 of Calibrate force sensor steps; then applying a known force to the plunger driver with a force gauge and comparing the sensor reading to an expected span window, page 24, step 2 of Force sensor check and page 92, step 5 of Calibrate force sensor steps).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the method of Wolff to determine the value indicative of sensitivity from the sensor signal taken with the holding element in the released position, in which the holding element does not hold the piston and is not in contact with the piston, as taught by Medfusion, in order to obtain a span/sensitivity reading without uncertain syringe-dimension tolerances in the load path. Wolff already discloses a released, no-piston-contact position of anti-siphon 17 and a processing device that evaluates force-sensor signals for zero and span diagnosis (page 10, lines 24-28, page 12, lines 8-19 and 31-34; page 13, lines 1-26). Medfusion supplies the teaching to take the span/sensitivity measurement with no syringe plunger in the load path
Conclusion
THIS ACTION IS MADE FINAL. 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 ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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