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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the moving track must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-4, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patrick et al. (US 20160228645 A1).
Regarding claim 1, Patrick discloses a voice-controlled drug injector (syringe 130, Fig 2), comprising an extension tube (tube conduit not shown; [0054]), a voice control receiver (voice-activated controller not shown; [0101]), and an injection pusher (syringe 130, Fig 2 + actuator assembly 120, Fig 2 + inner walls of cavity seen in Fig 7), wherein one end of the extension tube (tube conduit not shown; [0054]) is a liquid drug outlet (end of tube forming outlet of nerve block agent being injected to the patient; [0054]) and is connected to a needle (percutaneous needle, [0054]; end of tube connects to the injection needle), the other end of the extension tube (end of tube conduit ,not shown, connected to luer connector 141; Fig 3-4; [0054]) is a liquid drug inlet (end portion of tube functions as an inlet receiving medication from syringe 130, Fig 2-4) and is connected to one end of the injection pusher (130+120+ inner walls of cavity seen in Fig 7) to form a drug flowing channel (channel comprising syringe barrel connected to actuator at one end and in fluid connection to the inlet and outlet ends of tube conduit; Fig 2-4; [0054]), and the voice control receiver (voice-activated controller not shown; [0101]) is connected to the other end of the injection pusher (130+120+ inner walls of cavity seen in Fig 7) ([0063]; outer portion 114 encloses the controllers including the voice activated controller; [0101]; voice-activated controller is functionally connected to the other end of injection pusher. Input from voice causes movement of pusher as result of action from motor) and is configured to receive a voice control instruction (voice activated controller, not shown; is configured to receive voice command for activation) so as to control the injection pusher (130+120+ inner walls of cavity seen in Fig 7) to perform drug injection (voice-activated controller is functionally connected to the other end of injection pusher; input from voice causes movement of pusher as result of action from motor [0101]: “one or more other types of controllers can be used to allow a user to execute a procedure, such as for example, (…) voice-activated controller”)
Regarding claim 2, Patrick discloses the voice-controlled drug injector according to claim 1, further comprising a bottom plate (bottom plate 1000 supporting syringe 130 and internal components of the module 110 ; Fig 2 ), wherein the injection pusher (130+ 120+ inner walls of cavity seen in Fig 7) and the voice control receiver (voice-activated controller not shown; [0101]) are both arranged on the bottom plate (1000)
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Regarding claim 3, Patrick discloses the voice-controlled drug injector according to claim 2, wherein the injection pusher (130+120+ inner walls of cavity seen in Fig 7) comprises a syringe (syringe 130), and a propulsion device (actuator assembly 120 of the motor (not shown in FIG. 2) for driving the syringe (130); one end of the syringe (distal end of syringe 130, Annotated Fig 1) is connected to the liquid drug inlet (end of tube conduit ,not shown, connected to luer connector 141 functions as an inlet receiving medication from syringe 130, Fig 2-4; [0054]), and the other end of the syringe (proximal end of syringe 130, Annotated Fig 1) is connected to the propulsion device (120) by means of a core rod (movable member 136, Fig 2).
Regarding claim 4, Patrick discloses the voice-controlled drug injector according to claim 3, wherein the injection pusher (130+ 120+ inner walls of cavity seen in Fig 7) further comprises a pressing handle (inner walls of cavity seen in Fig 7 configured to fix the syringe 130 and pressure detection assembly 140 in place) for fixing the syringe (130), the propulsion device (120) comprises a push block (locking device 123, Fig 1) connected to the core rod (136) and configured to push the core rod (136) to move (actuator assembly includes actuator 122 and locking device 123 which secure the plunger 137 for movement of member 136; [0063], Fig 5), and a fixed seat (portion 1001, Annotated Fig 1) connected to the push block (Fixed seat 1001 is connected structurally 123); the pressing handle (internal walls of cavity containing the distal end portion of syringe 130) is arranged at one end of the bottom plate (distal portion of 1000, Annotated Fig 1), the fixed seat (1001, Annotated Fig 1) is arranged at the other end of the bottom plate ( proximal portion of 1000, Annotated Fig 1), and the push block (123) and the syringe (130) are located between the pressing handle (internal walls of cavity containing the distal end portion of syringe 130) and the fixed seat (1001, Annotated Fig 1)
Regarding claim 7, Patrick discloses the voice-controlled drug injector according to claim 4, wherein the pressing handle (internal walls of cavity containing the distal end portion of syringe 130) is provided with a clamping groove (cavity defined by the internal walls as seen in Fig 7 where syringe 130 is inserted), and the syringe (130) is clamped into the clamping groove for fixation (cavity seen in Fig 7; if distal end of syringe is not fixed, the force exerted by actuator assembly would cause displacement of the syringe 130 out of device and device 110 will not function as expected).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (US 20160228645 A1) in view of Wagner (US 20100268075 A1 ).
Regarding claim 5, Patrick discloses the voice-controlled drug injector according to claim 4. Patrick is silent wherein the propulsion device further comprises a guide rod for stabilizing a moving track, and a lead screw capable of reciprocating; the guide rod is arranged between the push block and the fixed seat , and the lead screw is arranged inside the guide rod and is connected to a driving device in the fixed seat.
Wagner teaches a drug injector (Fig 2C) comprising a propulsion device (syringe plunger drive assembly, Fig 2C) further comprises a guide rod (driving rod 74, Fig 3) for stabilizing a moving track (track in which coupler 94 is stabilized by driving rod 74; [0061]), and a lead screw (drive screw or shaft 66, Fig 2C) capable of reciprocating (drive screw reciprocates as results of motor 58 rotational torque in either direction; [0064]); the guide rod (74) is arranged between a push block (coupling 76) and the fixed seat (2000, Annotated Fig 2), and the lead screw (66) is arranged inside the guide rod (74) (Fig 2C) and is connected to a driving device (motor 58, Fig 2C) in the fixed seat (2000, Annotated Fig 2) ([0063]).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the propulsion device of Patrick with similar guide rod and lead screws in connection to the fixed seat and push block as taught by Wagner for the purpose of providing a reliable and secure mechanism to dispense the medication in a motorized manner ([0063]-[0065]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (US 20160228645 A1) in view of Gabriel et al. (US 20190091412 A1).
Regarding claim 6, Patrick discloses the voice-controlled drug injector according to claim 4. Patrick is silent wherein the fixed seat is internally provided with a power supply with a USB interface, and an encoder for monitoring the number of revolutions of the driving device.
Gabriel teaches a fixed seat (frame seen in Fig 9 and electrical components seen in Fig 6B) is internally provided with a power supply (battery 136, Fig 6B) with a USB interface (USB interface 138, Fig 6B), and an encoder (encoder 126, Fig 6B) for monitoring the number of revolutions of the driving device (Abstract: “ (…)encoder for evaluating output rotary motion of the motor (…)).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the fixed seat of device of Patrick with similar fixed seat comprising a USB, encoder and battery as taught by Gabriel for the purpose of having a power source rechargeable through USB connection that provides energy to the circuit to measuring rotatory output of the motor (abstract)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (US 20160228645 A1) in view of Schabbach (US 20210052819 A1).
Regarding claim 8, Patrick discloses the voice-controlled drug injector according to claim 4. Patrick is silent regarding wherein the push block is provided with a displacement sensor for calculating the amount of movement of the syringe, a converter for calculating injection dose according to the amount of movement, and a voice broadcaster for real-time broadcasting, and the converter is in signal connection with the displacement sensor and the voice broadcaster.
Schabbach teaches an injector (Fig 17) comprising a push block (drive sleeve 21, Fig 17) Is provided with a displacement sensor (dosage measurement system 100, Fig 1 comprising sensor unit; [0136];[0138]; sensor unit detects a signal indicative of the distance that dispensing member 23 has traveled ) for calculating the amount of movement of the syringe (dispensing member 23 of syringe; [0163]-[0164]: discloses that the container or injector device could be a syringe), a converter (processor ; [0138]) for calculating injection dose according to the amount of movement ([0138]: “The processor (not show) may be configured to determine a dosage dispensed from the injection device 1 based on a characteristic of the reflected signal detected by the sensor unit.”), and a voice broadcaster (user interface: buzzer; [0138]) for real-time broadcasting (buzzer emits sounds to user in real time), and the converter (processor; [0138]) is in signal connection with the displacement sensor (sensor unit ; [0138]) and the voice broadcaster (buzzer, [0138]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the push block of device of Patrick with a similar dose measurement system comprising a displacement sensor, a converter and voice broadcaster in signal connection as taught by Schabbach for the purpose of having means to identify the amount of dose being dispensed ([0138])
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (US 20160228645 A1) in view of Zeng et al. (CN 206482640 U).
Regarding claim 9, Patrick discloses the voice-controlled drug injector according to claim 1. Patrick is silent regarding further comprising a negative pressure airbag and a connecting tube, wherein one end of the connecting tube is connected to a sidewall of the extension tube, the other end of the connecting tube is connected to the negative pressure airbag, and a connecting part of the connecting tube and the extension tube is provided with a check valve for preventing the liquid drug from entering the negative pressure airbag.
Zeng teaches a system (Fig 1) comprising a syringe (syringe 1, Fig 1) a negative pressure airbag (airbag 7, Fig 1; [0031]) and a connecting tube (connecting pipe 6, Fig 1), wherein one end of the connecting tube (6) is connected to a sidewall of the extension tube (pipe 3, Fig 1), the other end of the connecting tube (6) is connected to the negative pressure airbag (7) (See Fig 1), and a connecting part of the connecting tube (6) and the extension tube (3) is provided with a check valve (check valve 602, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the extension tube of device of Patrick with similar connecting tube, negative pressure airbag and check valve as taught by Zeng for the purpose of assisting the drug release though a suction force ([0014])
Patrick/Zeng are silent wherein the check valve is preventing the liquid drug from entering the negative pressure airbag.
However, since the check valve can only be functionally positioned in two orientations, it would have been obvious to one of ordinary skill in the art to try and use the opposite orientation in the modified device of Patrick/Zeng to prevent medicine from going into the bag because when choosing from a finite number of predictable solutions a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (US 20160228645 A1).
Regarding claim 10, Patrick discloses the voice-controlled drug injector according to claim 3, wherein the syringe (130) is detachably connected to the propulsion device (120) ([0069]). Patrick embodiment of Fig 2-7 is silent regarding the syringe is externally provided with scales for observing the bolus dose of the liquid drug.
Patrick embodiment of Fig 10 teaches a syringe (syringe 230, Fig 10 ; [0079]) externally provided with scales (scale seen in Fig 10) for observing the bolus dose of the liquid drug (externally provided scale allow visualization of bolus dose of liquid nerve block agents).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the embodiment of Fig 2-7 of device of Patrick with similar external scales as taught by Patrick embodiment of Fig 10 for the purpose allowing the user to visualize measure and deliver an exact volume of nerve block agent ([0079]; Fig 10)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783