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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IN202141042483, filed on 9/20/2021.
Response to Amendment
In response to the amendment filed on 3/17/2025, no claims have been cancelled, and Claims 1-20 are pending.
Claim Objections
Claim 6 is objected to because of the following informalities: “a connected” should be “a connector”. Appropriate correction is required.
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, 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160166761 Piehl et al. (hereinafter Piehl) in view of US 8529509 Tojo et al. (hereinafter Tojo).
Regarding claim 1, Piehl discloses a dispensing device (10, Fig. 1) comprising:
a probe unit (syringe 48) including:
a housing (housing of syringe 48) configured to receive and store a sealant (it should be noted that a sealant is not a structural limitation of claim 1 and syringe 48 can be suited to receive and store a sealant) in a fluid state (paragraph 148),
a cannula (adapter tubing 109, Fig. 17) extending from a distal end of the housing, the cannula in fluid communication with the sealant stored inside the housing (Fig. 17, paragraph 164),
a valve (31)
a reservoir configured to store the sealant (a reservoir is inherently inside syringe 48 in order to accept and hold a sealant as in Fig. 1), wherein the reservoir is in fluid communication with the cannula via the valve (Fig. 17, paragraph 164), and
a plunger (41) configured to actuate flow of the sealant from the reservoir to the cannula via the valve (paragraph 17, 31, 48); and
a driver unit (paragraph 157, the system 100 is a powered motorized system, together with track 155 driving the plunger 41), wherein the probe unit is detachably mounted on the driver unit (paragraph 150, The shuttle mechanism 56 can have a slot 64 which accepts the outer end of the syringe plunger 41. Slot 64 can be open at the top so a syringe 48 can be dropped in from above; as seen in Fig. 14b, 22, the syringe 48 can be dropped in from above), the driver unit including:
a motor (151, Fig. 11),
a motor shaft coupled to the motor (paragraph 157, as seen in Fig. 11, the motor 151 is coupled to a motor shaft that is between the motor and pinion gear 154), and
a pusher (155, Fig. 11),
wherein the pusher is configured to receive and connect with the plunger when the probe unit is mounted on the driver unit (paragraph 157).
Piehl discloses that a number of other gear combinations and configurations can be used, including a worm gear, a series of spur gears, planetary gears and/or bevel gears (paragraph 157), however does not explicitly disclose a worm shaft coupled to the motor shaft, the motor configured to cause the motor shaft and the worm shaft to rotate, a gear coupled to the worm shaft such that rotation of the worm shaft causes the gear to rotate, the pusher parallel to the worm shaft and configured to engage the gear, and rotation of the gear causing the pusher to move laterally.
However, Tojo teaches a device for dispensing medication through a syringe (abstract, col. 1 line 6-12) having a driving unit that comprises a motor (17, Fig. 3), a worm shaft (18) coupled to the motor through a motor shaft (17a), the motor configured to cause the motor shaft and the worm shaft to rotate (col. 7 line 8-12), a gear (19) coupled to the worm shaft such that rotation of the worm shaft causes the gear to rotate (col. 7 line 10-12), a pusher (24a/24b) parallel to the worm shaft (as seen in Fig. 3) and configured to engage the gear (col. 7 line 10-45, pusher 24a/24b are coupled to the gear 19 through gears 22a/22b and gears 23a/23b), and rotation of the gear causing the pusher to move laterally (col. 7 line 10-45).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the gear drive mechanism as taught by Piehl with the worm shaft and gear drive mechanism as taught by Tojo since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the worm shaft and gear drive mechanism of Tojo would be sufficient to provide lateral motion to the pusher.
Regarding claim 6, the combination of Piehl and Tojo teaches the limitations of claim 1, and Piehl further discloses wherein the plunger includes a snap feature or a connecter (as seen in Fig. 11 and further embodiments in Fig. 1 and 6, the distal end of the plunger is shaped with a connector so as to couple with the pusher) that is configured to couple to the pusher when the probe unit is mounted on the driver unit (paragraph 157).
Regarding claim 7, the combination of Piehl and Tojo teaches the limitations of claim 1, and Piehl further discloses wherein an end of the pusher includes a tab (156, 14, Fig. 11, 12) that is configured to engage a first end of the plunger (paragraph 157).
Claims 2-5, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Piehl in view of Tojo as applied to claim 1 above, and further in view of US 4036223 Obert.
Regarding claim 2, the combination of Piehl and Tojo teaches the limitations of claim 1. Piehl and Tojo further disclose a chassis (body of the device 10, Fig. 1 of Piehl; drive section 5 of device 1 of Tojo, Fig. 1).
The combination is silent on wherein the driver unit includes a chassis configured to at least support ends of the worm shaft.
However, Obert teaches an apparatus for delivering materials through syringes (abstract, col. 1 line 5-28) that comprises a driver unit (combination of motor 17, worm shaft 15, that drives pusher 13a/13b, Fig. 2, col. 4 line 33-36), the driver unit including a chassis (36, 37, Fig. 2) configured to at least support ends of the worm shaft (as seen in Fig. 2, col. 3 line 62-66, col. 4 line 37-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Piehl with Tojo with the teachings of Obert in order to provide a stable and smooth rotation of the worm shaft.
Regarding claim 3, the combination of Piehl, Tojo and Obert teaches the limitations of claim 2, and Obert teaches wherein the driver unit includes a flanged bearing (19/20/21, Fig. 1-2) coupled to a portion of the chassis and an end of the worm shaft to enable the worm shaft to rotate while being supported by the chassis (col. 3 line 62-66, col. 4 line 37-39).
Regarding claim 4, the combination of Piehl, Tojo and Obert teaches the limitations of claim 2, and Tojo teaches wherein the chassis includes at least one track (25a/25b, Fig. 1-4) configured to retain the pusher on the chassis and guide the pusher laterally along the chassis (as seen in Fig. 1-4, col. 7 line 18-27).
Regarding claim 5, the combination of Piehl, Tojo and Obert teaches the limitations of claim 4, and Tojo teaches wherein the motor, the motor shaft, and the worm shaft are located on an opposite side of the chassis from the at least one track and the pusher (as seen in Fig. 3).
Regarding claim 8, the combination of Piehl, Tojo and Obert teaches the limitations of claim 5, and Piehl further discloses wherein the plunger includes a second end that is disposed within the reservoir (as seen in Fig. 1, the plunger 41 is disposed inside the reservoir of the syringe 48).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Piehl in view of Tojo as applied to claim 1 above, and further in view of US 20160271329 Park.
Regarding claim 9, the combination of Piehl and Tojo teaches the limitations of claim 1.
The combination is silent on wherein the housing includes a bottom cover having a window, and wherein the pusher connects to the plunger through the window of the bottom cover.
However, Park teaches a drug injection device (abstract, paragraph 1, 16) having a probe unit (300, Fig. 7-8) wherein a housing (outer housing of probe unit 300) includes a bottom cover having a window (320, Fig. 7-8, 10-12), and wherein a pusher (221, Fig. 7-12) connects to a plunger (30, Fig. 9-11) through the window of the bottom cover (as seen in Fig. 7, 10-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Piehl with Tojo with the teachings of Park in order to provide an opening that allows full contact of the plunger with the pusher to actuate the plunger.
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Piehl in view Tojo as applied to claim 1, and further in view of US 20150150546 Goldschmidt.
Regarding claim 10, the combination of Piehl and Tojo teaches the limitations of claim 1, and Piehl further discloses wherein the probe unit further includes:
an identification tag (RFID 1116, Fig. 28) configured to wirelessly transmit an identifier that identifies the probe unit (paragraph 186, The system may also have an RFID 1116, barcode, or other information on the body of the syringe which can provide information to the motorized system 1100 about the type of tubing inserted).
The combination is silent on the probe unit further including a magnet configured to provide a magnetic field.
However, Goldschmidt teaches a detachable surgical utility connector (abstract) that uses magnets and Hall effect sensors to detect the presence of the surgical utility connector when it is connected to a surgical utility supplying device (abstract, paragraph 6-7, 9-11, 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Piehl with Tojo with the teachings of Goldschmidt in order to consistently detect the connection or disconnection of the device as disclosed by Goldschmidt (paragraph 24).
Regarding claim 11, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 10, and the combination further teaches wherein the driver unit further includes:
a hall sensor arranged to detect the magnet in response to the probe unit being mounted on the driver unit (Goldschmidt: paragraph 24, magnets and Hall effect sensors are used to detect the presence of a surgical utility connector disposed in a surgical utility supplying device);
a controller configured to obtain the identifier from the identification tag of the probe unit in response to the hall sensor detecting the magnet (Goldschmidt: paragraph 10, 24, 27-29, 55, a processor (controller) determines whether the surgical implement is engaged to the utility port based on the detection of the hall-effect sensor and upon the hall sensor detecting the magnet reads an RFID tag on the surgical utility connector); and
a display (Piehl: 90/1130, Fig. 9, 29) configured to display an indication of the identifier of the probe unit (Piehl: paragraph 155, 190).
Regarding claim 12, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 11, and Piehl further discloses wherein the controller (158, Fig. 11) is further configured to:
generate a control signal for controlling the motor (paragraph 157);
determine an amount of the sealant inside the reservoir based on the control signal (paragraph 155-156, 220, ; and
cause the display to display the determined amount of the sealant inside the reservoir (paragraph 37-39, 155-156, 190, 210-211).
Regarding claim 13, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 11, and Piehl further discloses wherein the identification tag (RFID 1116 tag) is a near field communication (NFC) tag (NFC is a known subset within the family of RFID technology (https://www.atlasrfidstore.com/rfid-insider/rfid-vs-nfc/)).
Regarding claim 14, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 11, and Piehl further discloses wherein the display is disposed at a proximal end of the driver unit (as seen in Fig. 9, display 90 is at a proximal end to the user when handling the device).
Regarding claim 15, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 11, and Piehl further discloses wherein the driver unit further includes a trigger (37’, Fig. 11) electrically connected to the controller (paragraph 157), the trigger configured to detect a tactile input and transmit signals to the controller when tactile inputs are detected (paragraph 157), thereby causing the controller to cause the motor to rotate to dispense the sealant from the reservoir by moving the pusher laterally (paragraph 157).
Regarding claim 16, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 15, and Piehl further discloses wherein the controller is configured to enable a user to select a fixed amount of the sealant to be dispensed from the reservoir when the trigger detects a tactile input (paragraph 157, 226-227).
Regarding claim 17, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 16, and Piehl further discloses wherein the controller is configured to cause the display to show the fixed amount selected by the user (paragraph 37-39, 155-156, 190, 210-211).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Piehl in view Tojo and further in view of Goldschmidt as applied to claim 16, and further in view of US 4741736 Brown.
Regarding claim 18, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 16.
The combination is silent on wherein the controller converts the fixed amount into a duration of time that the motor is to be activated.
However, Brown teaches a programmable infusion pump (abstract) wherein a set volume of fluid is programmed into a controller (96, Fig. 7) that controls a motor (88, Fig. 8) for a pump and sets the duration for the pump to infuse the fluid (col. 10 line 37-63, col. 43 line 63-68, col. 45 line 36-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Piehl with Tojo and Goldschmidt with the teachings of Brown in order to accurately dispense a set amount of fluid.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Piehl in view Tojo and further in view of Goldschmidt as applied to claim 16, and further in view of US 4529401 Leslie et al. (hereinafter Leslie).
Regarding claim 19, the combination of Piehl, Tojo and Goldschmidt teaches the limitations of claim 16.
The combination is silent on wherein the controller includes a manual mode and an automatic mode, the fixed amount corresponding to the automatic mode, and
wherein when the manual mode is selected, the controller is configured to cause the motor to actuate as long as the trigger detects tactile inputs.
However, Leslie teaches a programmable infusion pump (abstract) wherein the controller (100, Fig. 4c) includes a manual mode (“PRIME” function, col. 3 line 3-11) and an automatic mode (“MANUAL” function, col. 3 line 3-11), the fixed amount corresponding to the automatic mode (col. 11 line 45-67), and
wherein when the manual mode is selected, the controller is configured to cause the motor (50, Fig. 2) to actuate as long as the trigger (“ENTER” key) detects tactile inputs (col. 8 line 56 – col. 9 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Piehl with Tojo and Goldschmidt with the teachings of Leslie in order to provide enhanced user control and finer adjustments for the delivery of fluid.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Piehl in view Tojo as applied to claim 1, and further in view of US 20190321837 Bhogal et al. (hereinafter Bhogal).
Regarding claim 20, Piehl discloses the limitations of claim 1.
Piehl is silent on wherein the driver unit further includes at least one rail positioned on a top side of the driver unit, the at least one rail configured to provide a track for receiving and retaining the probe unit when the probe unit is mounted on the driver unit.
However, Bhogal teaches a modular syringe attachment device 14 (probe) that can be mounted on a handheld device 12 (driver) (Fig. 5 and 6). On the handheld device are rails (protrusions 83 and 84) which provide a track that corresponds with the keyholes 76 and 78 of the syringe attachment device (paragraph 54). This allows for the separation and attachment of devices 12 and 14.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Piehl with Tojo with the rail configuration providing a track for receiving the probe as taught by Bhogal in order to yield predictable results with no change in their respective functions. One of ordinary skill in the art would have been motivated to make this modification to allow for reuse and sterilization of the handheld device 12 (driver) and the disposing of the syringe attachment device 14 (probe) after applying treatment to the patient as disclosed by Bhogal (paragraph 82).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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