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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/27/2025 has been entered.
Response to Amendment
Applicant has amended claims 1, 3, 10-11, and 13, and canceled claim 12; claims 1-11 and 13 remain pending.
No new claim objections or rejections under 35 USC 112 are found in the amended claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Traversaz et al. (US 20120215170, henceforth Traversaz) in view of Jiang et al. (US 20180326145, henceforth Jiang) and Kiyatake et al. (US 20030060768, henceforth Kiyatake).
Regarding claim 1, Traversaz discloses an infusion device (see assembly of fig. 1) for administering a medical fluid to a patient ([0002]), comprising: a receptacle (syringe cradle 200, fig. 1) for receiving a syringe (syringe 400, fig. 1 and [0029]), a pusher device (push device 300, fig. 1) movable in a pushing direction (see Abstract and [0029], the pushing direction as seen in fig. 2 is from lever 310 towards brake 620) for acting onto a piston of the syringe received in the receptacle (push head 401 and piston 402 of syringe 400 make up the claimed syringe piston, see fig. 1), a fastening element (two pivotable arms 304 make up the claimed element, see figs. 1 and 2) arranged on the pusher device (see figs. 1 and 2) and movable in between a non-actuated position (see position of fig. 9a) in which the fastening element has not been actuated (see fig. 9a, the two pivotable arms 304 have not been actuated as they are closed and biased to push directly against each other) and no syringe is placed on the infusion device (see fig. 10a; this is a position showing pivotable arms 304 in a non-actuated position as claimed and without a syringe present as shown) and a fully actuated position in which the fastening element is fully raised from the non-actuated position (see fig. 11b; pivotable arms 304 have been fully raised as compared to the state of fig. 10a where the arms were biased to be in direct contact with one another) with respect to the pusher device (see position of fig. 9b) with an intermediate position in between the non-actuated position and the fully actuated position (pivotable arms 304 are formed on hinges as shown in figs. 9-11 and are movable between a continuum of positions since they cannot jump from one position to another without being in an intermediate position between as they must rotate open and closed about their hinges; a position in between the states of figs. 9a and 9b is an intermediate position as claimed), a brake device (electromagnetic brake 620, fig. 2) for braking a movement of the pusher device ([0040]), and a control device (control means 600, [0040]) for controlling operation of the brake device (see [0040]). Additionally, Traversaz discloses that the control device is configured to control the brake device based on an output of sensors to assume a braking state for braking a movement of the pusher device or a non-braking state for allowing a movement of the pusher device (see [0041]).
Traversaz does not disclose a fastening element sensing device configured to sense the non-actuated position of the fastening element with respect to the pusher device and the fully actuated position, or the control device being configured to control the brake device based on an output of the fastening element sensing device. Jiang teaches a fastening element similar to that of Traversaz (clamping assembly 35 which includes two claws 351, see fig. 1) and a fastening element sensing device (combination of pressure sensing assembly 33 including pressure sensor 331 and angular displacement sensor 353, see [0044] and [0053]) for sensing a position state of the fastening element (see [0053]) with respect to a pusher device equivalent to that of Traversaz (propulsion mechanism 3, fig. 1), with the position state including a non-actuated position, an intermediate position, and a fully actuated position (see [0052], claws 351 can be rotated continuously from a closed position to an open position, with the closed and open positions being non-actuated and fully actuated positions equivalent to those of the device of Traversaz; also see [0053] which discloses that sensor 353 senses the position of claws 351, and since the equivalent positions are present and the sensors senses the positions of the claws, this is a teaching of the configuration of the fastening element sensing device as claimed, where the intermediate position is a position between the actuated position and the non-actuated position as the claws 351 rotate about hinges and must do so about a continuum of rotation angles), and the use of the output of the fastening element sensing device by a control device (see connection of sensor to control system to acquire a state of one of the claws 351 as in [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the fastening element sensing device of Jiang to the infusion device of Traversaz for providing an exact angular position of the fastening element of Traversaz in real time (see Jiang [0053]).
Further, Jiang teaches that an injection of its injection device cannot occur until the fastening element has properly secured the piston of the syringe (see Jiang [0057] and [0058]). This further demonstrates that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the control device of Traversaz to control its brake device based on an output of the fastening element sensing device as claimed, as this information from the added sensor of Jiang is what allows an injection to be completed, which includes releasing the brake in Traversaz (see Traversaz [0040] and [0051]). Releasing the brake constitutes a non-braking state for allowing a movement of the pusher device (see Traversaz [0051]).
Traversaz as modified does not disclose the infusion device comprising a directional movement sensing device for detecting a movement of the pusher device in the pushing direction and a movement of the pusher device opposite the pushing direction wherein the control device is configured to control the brake device to assume the braking state (i) with the fastening element not in the fully actuated position and the movement of the pusher device in the pushing direction and (ii) with the fastening element in the intermediate position and the movement of the pusher device the opposite the pushing direction. Kiyatake teaches an infusion device (assembly of fig. 2) comprising a pusher device (pushing holder 7, fig. 2) and a control device (CPU 1, fig. 2) configured for controlling the pusher device (see [0006]) and a directional movement sensing device (position detecting sensor 13, fig. 2, which includes first sensor 13-1 and second sensor 13-2) for detecting a movement of the pusher device in the pushing direction and a movement of the pusher device opposite the pushing direction (see at least [0025] and [0028], the two sensors cooperate to read both rightward movements denoting a restarting and leftward movements denoting an infusion, where rightwards in Kiyatake is the direction opposite the pushing direction and leftward is the pushing direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the directional movement sensing device of Kiyatake to the infusion device of Traversaz as modified for providing information about the movement of the drive motor such as to be able to accurately determine time remaining and liquid infusion finishing position as in Kiyatake (see at least [0025]-[0028]). Such a modification could be achieved by adding the sensors and dog of Kiyatake to the assembly and nut (611) of Traversaz such as to similarly read the displacement about a component which is tied to a lead drive screw for measurement purposes.
Further, in the modified device of Traversaz in view of Jiang and Kiyatake, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the modified device such that the control device of Traversaz (control means 600, [0040]) is configured to control the infusion device to assume a braking state (i) with the fastening element not in the fully actuated position and the movement of the pusher device in the pushing direction and (ii) with the fastening element in the intermediate position and the movement of the pusher device the opposite the pushing direction as claimed because the teachings of Jiang ([0057] and [0058]) instruct a skilled artisan to require that a syringe is properly mounted prior to injection which is confirmed through the use of sensors including the sensor which measures the fastening element; in the two scenarios listed, the fastening element is not configured to be properly mounted onto the syringe since it is (i) not in the fully actuated position and (ii) in the intermediate position, and thus in applying the teachings of Jiang, one of ordinary skill in the art would configured to controller to assume the braking state in the scenarios as claimed.
Regarding claim 2, Traversaz as modified discloses the device wherein the control device is configured to control the brake device based on an output of the fastening element sensing device (see rejection of claim 1) and an output of at least one further sensing device (see [0051] including engagement sensor 722 which is a sensing device).
Regarding claim 3, Traversaz as modified discloses the device wherein the control device is configured to control the brake device to assume the braking state if an output of the fastening element sensing device indicates that the fastening element is in the intermediate position (Jiang [0058] teaches that the syringe must be mounted, and this only occurs once claws 351 clamp onto the piston rod of the syringe. This indicates that in an intermediate state where claws 351 are not clamped, infusion would not be allowed. This is maintained in the modified device of Traversaz through use of the braking state as indicated in claim 1.) and if in addition an output of at least one further sensing device indicates that the pusher device is not in operative connection with the piston of the syringe (see discussion of contact sensor of [0041]).
Regarding claim 4, Traversaz as modified discloses the device further comprising a presence sensing device (contact sensor of [0041]) for sensing a presence of the piston of the syringe on the pusher device (see [0041]), wherein the control device is configured to control the brake device to assume the braking state or the non-braking state based in addition on an output of the presence sensing device (see state change causing actuation of the brake as in [0041]).
Regarding claim 5, Traversaz as modified discloses the device further comprising a driving rod (threaded driving rod 501, fig. 3), an electric drive device (motor 502, fig. 3) for driving the driving rod (see [0056], it is understood that motor 502 drives driving rod 501), and a driving assembly (cart 350, fig. 2) comprising at least one clutch element (two mobile half-nuts 351, fig. 3 and [0038]), the at least one clutch element being configured to operatively connect, in a clutched state, the driving rod to the pusher device (engaged position is clutched state, see [0038] and fig. 8a) for driving the pusher device by the electric drive device (see [0055] and [0056]), the driving assembly being actuatable to assume an unclutched state in which an operative connection between the driving rod and the pusher device is released (disengaged position is unclutched state as in [0038] and [0057], see figs. 3b and 8b).
Regarding claim 6, Traversaz as modified discloses the device further comprising a clutch sensing device (sensor 730 of [0046]) for sensing a state of the driving assembly (see [0046]), wherein the control device is configured to control the brake device to assume the braking state or the non-braking state based in addition on an output of the clutch sensing device (see [0048] and [0049]).
Regarding claim 7, Traversaz as modified discloses the device further comprising an actuation device (lever 310, figs. 6a-c) for actuating the fastening element (see [0039], [0042], [0044]) to move the fastening element with respect to the pusher device and the driving assembly (see [0044] and figs. 6a-c and 9a-c) to assume the unclutched state (see [0044]).
Regarding claim 8, Traversaz as modified discloses the device wherein the actuation device is movably arranged on the pusher device (see [0044] and figs. 6a-c and 9a-c).
Regarding claim 9, Traversaz as modified discloses the device further comprising an actuation sensing device (optical engagement sensor 722 of [0044]) for sensing a state of the actuation device (see [0044]), wherein the control device is configured to control the brake device to assume the braking state or the non-braking state based in addition on an output of the actuation sensing device (see [0044] and [0045]).
Regarding claim 10, Traversaz as modified discloses the device wherein the control device is configured to transfer the brake device from the braking state to the non-braking state if an output of the fastening element sensing device indicates that the fastening element is not in the intermediate position in between the non-actuated position and the fully actuated position and in addition at least one of an output of the actuation sensing device indicates that the actuation device is not actuated and an output of a clutch sensing device indicates that the driving assembly is in the clutched state (Jiang [0058] teaches that the syringe must be mounted for infusion to occur, and this only occurs once claws 351 clamp onto the piston rod of the syringe. This indicates that in the intermediate state where claws 351 are not clamped, infusion would not be allowed. This is maintained in the modified device of Traversaz through use of the braking state as indicated in claim 1. Thus, if the fastening element is non-actuated and fully clamped onto the piston syringe, the brake can be changed into the non-braking state. Further, as shown in Table 2 at the step of “Release of the lever”, clutch sensing device including sensor 730 reads engaged, indicating a clutched state as in [0046], when the electromagnetic brake is deactivated and sent into the non-braking state.).
Regarding claim 11, Traversaz as modified discloses the device wherein the control device is configured to transfer the brake device from the braking state to the non-braking state if an output of the fastening element sensing device indicates that the fastening element is not in the intermediate position in between the non-actuated position and the fully actuated position and in addition at least one of an output of the actuation sensing device indicates that the actuation device is actuated and an output of a clutch sensing device indicates that the driving assembly is in the unclutched state (Jiang [0058] teaches that the syringe must be mounted, and this only occurs once claws 351 clamp onto the piston rod of the syringe. This indicates that in an intermediate state where claws 351 are not clamped, infusion would not be allowed. This is maintained in the modified device of Traversaz through use of the braking state as indicated in claim 1. Thus, if the fastening element is non-actuated and fully clamped onto the piston syringe, the brake can be changed into the non-braking state. Further, as shown in Table 2 at the step of “Lever pushed down to administrate a voluntary bolus”, clutch sensing device including sensor 730 reads disengaged, indicating an unclutched state as in [0046], when the electromagnetic brake is deactivated and sent into the non-braking state compared to the earlier state of the push device coming in contact with the syringe head as shown.).
Regarding claim 13, Traversaz discloses a method for controlling operation of an infusion device (see assembly of fig. 1), comprising: providing a pusher device (push device 300, fig. 1) movable in a pushing direction (see Abstract and [0029]) for acting onto a piston (push head 401 and piston 402 of syringe 400 make up the claimed syringe piston, see fig. 1) of a syringe (syringe 400, fig. 1) received in a receptacle of the infusion device (syringe cradle 200, fig, 1), moving a fastening element arranged on the pusher device (two pivotable arms 304 make up the claimed element, see figs. 1 and 2) in between a non-actuated position (see position of fig. 9a) in which the fastening element has not been actuated (see fig. 9a, the two pivotable arms 304 have not been actuated as they are closed and biased to push directly against each other) and no syringe is placed on the infusion device (see fig. 10a; this is a position showing pivotable arms 304 in a non-actuated position as claimed and without a syringe present as shown) and a fully actuated position in which the fastening element is fully raised from the non-actuated position (see fig. 11b; pivotable arms 304 have been fully raised as compared to the state of fig. 10a where the arms were biased to be in direct contact with one another) with respect to the pusher device (see position of fig. 9a and 9b, respectively) with an intermediate position in between the non-actuated position and the fully actuated position (pivotable arms 304 are formed on hinges as shown in figs. 9-11 and are movable between a continuum of positions since they cannot jump from one position to another without being in an intermediate position between as they must rotate open and closed about their hinges; a position in between the states of figs. 9a and 9b is an intermediate position as claimed), braking, using a brake device, a movement of the pusher device (electromagnetic brake 620, fig. 2 and [0040]), and controlling, using a control device, the brake device (control means 600, [0040]), to assume a braking state for braking a movement of the pusher device or a non-braking state for allowing a movement of the pusher device (see [0040] and [0041]). Additionally, Traversaz discloses that the control device is configured to control the brake device based on an output of sensors to assume a braking state for braking a movement of the pusher device or a non-braking state for allowing a movement of the pusher device (see [0041]).
Traversaz does not disclose sensing, using a fastening element sensing device, the non-actuated position and the fully actuated position of the fastening element with respect to the pusher device, or the control device being configured to control the brake device based on an output of the fastening element sensing device. Jiang teaches a fastening element similar to that of Traversaz (clamping assembly 35 which includes two claws 351, see fig. 1) and a fastening element sensing device (combination of pressure sensing assembly 33 including pressure sensor 331 and angular displacement sensor 353, see [0044] and [0053]) for sensing a position state of the fastening element (see [0053]) with respect to a pusher device equivalent to that of Traversaz (propulsion mechanism 3, fig. 1), the position state including a non-actuated position, an intermediate position, and a fully actuated position (see [0052], claws 351 can be rotated continuously from a closed position to an open position, with the closed and open positions being non-actuated and fully actuated positions equivalent to those of the device of Traversaz; also see [0053] which discloses that sensor 353 senses the position of claws 351, and since the equivalent positions are present and the sensors senses the positions of the claws, this is a teaching of the configuration of the fastening element sensing device as claimed, where the intermediate position is a position between the actuated position and the non-actuated position as the claws 351 rotate about hinges and must do so about a continuum of rotation angles) and the use of the output of the fastening element sensing device by a control device (see connection of sensor to control system to acquire a state of one of the claws 351 as in [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the fastening element sensing device of Jiang to the infusion device of Traversaz for providing an exact angular position of the fastening element of Traversaz in real time (see Jiang [0053]).
Further, Jiang teaches that an injection of its injection device cannot occur until the fastening element has properly secured the piston of the syringe (see Jiang [0057] and [0058]). This further demonstrates that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the control device of Traversaz to control its brake device based on an output of the fastening element sensing device as claimed, as this information from the added sensor of Jiang is what allows an injection to be completed, which includes releasing the brake in Traversaz (see Traversaz [0040] and [0051]). Releasing the brake constitutes a non-braking state for allowing a movement of the pusher device (see Traversaz [0051]).
Traversaz as modified does not disclose the infusion device comprising a directional movement sensing device for detecting a movement of the pusher device in the pushing direction and a movement of the pusher device opposite the pushing direction wherein the control device is configured to control the brake device to assume the braking state (i) with the fastening element not in the fully actuated position and the movement of the pusher device in the pushing direction and (ii) with the fastening element in the intermediate position and the movement of the pusher device the opposite the pushing direction. Kiyatake teaches an infusion device (assembly of fig. 2) comprising a pusher device (pushing holder 7, fig. 2) and a control device (CPU 1, fig. 2) configured for controlling the pusher device (see [0006]) and a directional movement sensing device (position detecting sensor 13, fig. 2, which includes first sensor 13-1 and second sensor 13-2) for detecting a movement of the pusher device in the pushing direction and a movement of the pusher device opposite the pushing direction (see at least [0025] and [0028], the two sensors cooperate to read both rightward movements denoting a restarting and leftward movements denoting an infusion, where rightwards in Kiyatake is the direction opposite the pushing direction and leftward is the pushing direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the directional movement sensing device of Kiyatake to the infusion device of Traversaz as modified for providing information about the movement of the drive motor such as to be able to accurately determine time remaining and liquid infusion finishing position as in Kiyatake (see at least [0025]-[0028]). Such a modification could be achieved by adding the sensors and dog of Kiyatake to the assembly and nut (611) of Traversaz such as to similarly read the displacement about a component which is tied to a lead drive screw for measurement purposes.
Further, in the modified device of Traversaz in view of Jiang and Kiyatake, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the modified device such that the control device of Traversaz (control means 600, [0040]) is configured to control the infusion device to assume a braking state (i) with the fastening element not in the fully actuated position and the movement of the pusher device in the pushing direction and (ii) with the fastening element in the intermediate position and the movement of the pusher device the opposite the pushing direction as claimed because the teachings of Jiang ([0057] and [0058]) instruct a skilled artisan to require that a syringe is properly mounted prior to injection which is confirmed through the use of sensors including the sensor which measures the fastening element; in the two scenarios listed, the fastening element is not configured to be properly mounted onto the syringe since it is (i) not in the fully actuated position and (ii) in the intermediate position, and thus in applying the teachings of Jiang, one of ordinary skill in the art would configured to controller to assume the braking state in the scenarios as claimed.
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
Applicant has argued that the combination of Traversaz and Jiang does not disclose the fastening element sensing device as claimed where the control device is configured to control the brake device based on an output of the fastening element sensing device. Examiner respectfully disagrees. Jiang teaches a fastening element sensing device (353 in particular) which is configured to detect a rotation angle of one of its fastening elements. The rotation angle varies depending on the state of the fastening element, from fully actuated as claimed to not actuated as claimed, and all angles in between, as it is used for giving a particular angular displacement of the claw. Thus, it is the Examiner’s position that Jiang teaches the fastening element sensing device as claimed and that the combination is actively sensing the claimed positions since a sensor which measures angular position would be sensing the positions as claimed since they are included in the continuum of positions which are capable of being sensed by the sensor and they are positions which occur in the modified device.
Applicant has additionally argued that the combination of Traversaz, Jiang, and Gillespie did not disclose the newly amended independent claims; this argument has been considered but is moot because the new ground of rejection does not rely on Gillespie as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As shown in [0025] and [0028] of Kiyatake, leftward and rightward movement are called out as being sensed by sensor 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pippin et al. (US 20190351132) is considered relevant prior art where it teaches use of a displacement sensor with a directional movement sensing device (motor position sensor 896, fig. 8 and [0098]) for detecting a movement of the pusher device in the pushing direction and a movement of the pusher device opposite the pushing direction (the motor position sensor 896 is used to detect the position and movements of the motor 850, [0098] and [0106], and sensor 896 would measure bidirectional movements of the motor since it is measuring motor positions and differences between positions could be done between measurements to determine rate of motor speed in either direction).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783