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. 18/547,675, filed on 08/23/2023.
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.
Claim(s) 1-6, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coleman (US 20180318543 A1).
Regarding claim 1, Coleman teaches a portable ([0033] [0031] Some embodiments of the fluid delivery device may be improved for portability) cooling device for administering a coolant to a bodily cavity of a user (Fig 1A; [0078] he liquid delivery tube 234A can be connected to the fluid reservoir 160A which can comprise a reservoir of liquid and/or a pump for delivering the liquid from the fluid reservoir 160A to the liquid delivery tube 234A), the portable cooling device comprising: a flow transducer ([0078] The gas delivery tube 232A can be connected to a gas source 60A which can provide pressurized and/or unpressurized air and/or gas to the gas delivery tube 232A. The term “gas source” is a broad term that is intended to comprise any source for pressurized and/or unpressurized air and/or gas such that the gas source 60A can comprise any of a wide variety of sources of pressurized and/or unpressurized air and/or gas such as, for example, a pressurized air and/or gas tank and/or a pump and/or compressor and/or an opening and/or connection to atmospheric air) configured to provide an airflow to the bodily cavity of the user ([0078]); and a pressure transducer ([0078] 19A) configured to inject the coolant ([0078] The suction tube 230A can be placed in communication with a vacuum source 19A. The fluid reservoir 160A can include a pump 19A′ for delivering liquid from the fluid reservoir 160A through the liquid delivery tube 234A and the liquid delivery passage 2608A and to the delivery device 40A. The vacuum source 19A can be used to apply suction or vacuum through the suction tube 230A, the suction passage 2612A and the delivery device 40A) into the airflow (gas delivery tube 232A) ([0078] the suction tube 240 can also be in fluid communication with the fluid reservoir such that any liquid withdrawn through the suction tube 240 can be returned to the fluid reservoir 160A. As will be explained below, in certain embodiments, a single pump can be used to alternatively replace or with the fluid reservoir 160A under pressure or under vacuum such that the fluid reservoir can function as the vacuum source in communication with the suction tube 230A and/or the pressure source in communication with 234A); wherein the flow transducer (60A) and the pressure transducer (19a) are separate components (Fig 1A).
Regarding claim 2, Coleman teaches the portable cooling device of claim 1, wherein the airflow is provided to the cavity of the user by means of a first tubing (Fig 1A; gas delivery tube 232A).
Regarding claim 3, Coleman teaches the portable cooling device of claim 1, further comprising a coolant container comprising the coolant (Fig 1A; fluid reservoir 160A).
Regarding claim 4, Coleman teaches the portable cooling device of claim 3, wherein the coolant container is arranged to be pressurized by the pressure transducer via a second tubing ([0078] The suction tube 230A can be placed in communication with a vacuum source 19A. The fluid reservoir 160A can include a pump 19A′ for delivering liquid from the fluid reservoir 160A through the liquid delivery tube 234A and the liquid delivery passage 2608A and to the delivery device 40A. The vacuum source 19A can be used to apply suction or vacuum through the suction tube 230A, the suction passage 2612A and the delivery device 40A. In the illustrated embodiment, the suction tube 240 can also be in fluid communication with the fluid reservoir such that any liquid withdrawn through the suction tube 240 can be returned to the fluid reservoir 160A. As will be explained below, in certain embodiments, a single pump can be used to alternatively replace or with the fluid reservoir 160A under pressure or under vacuum such that the fluid reservoir can function as the vacuum source in communication with the suction tube 230A and/or the pressure source in communication with 234A); and wherein the coolant container is arranged to inject the coolant into the airflow via a third tubing (Fig 1A; Liquid delivery tube 234A) ([0093] the check valve 2650I can be configured to only open in the direction 2340B that allows a liquid to flow from a liquid delivery tube 234B to the endotracheal tube 40B. The check valve 2650III can be configured to only open in the direction 2320B that allows the air and/or oxygen and/or other gases to flow from a gas delivery tube 2320B to the endotracheal tube 40B. The check valve 2650II can be configured to only allow flow in the direction 2300B that allows a mixture of liquid(s) and gas(es) that was in the patient's lungs to flow from the endotracheal tube 40B to the suction tube 230B).
Regarding claim 5, Coleman teaches portable cooling device of claims 4, wherein the coolant container further comprises a first terminal connected to the second tubing, and a second terminal connected to the third tubing (Fig 1A; Fluid reservoir 106A connected to tubing 230A and 234A).
Regarding claim 6, Coleman teaches the portable cooling device of claim 5, wherein the cooling container further comprises a closure having at least one of the first terminal and the second terminal ([Fig 1A; [0122] As shown in FIG. 2B, the canister 160 is air-sealed with a canister lid 170).
Regarding claim 11, Coleman teaches the portable cooling device of claim 1, further comprising at least one controller ([0081] As shown in FIG. 1A, the pressure sensor 400A can be operatively connected to a control unit 186A. The control unit 186A can use the information from the pressure sensor 400A to output electrical signals and/or instructions (as described below) to control the flow of the liquid and gas between the tube assembly 20A and the endotracheal tube 40A by controlling opening and closing of one or more two-way valves (described below) that can be provided in the hub 260A and/or in other parts of the apparatus 1A, such as a manifold as described in a later illustrated embodiment. Accordingly, in the illustrated arrangement, the control unit 186A can be operatively connected to a suction valve 2620A, a gas delivery valve 2622A and/or a liquid delivery valve 2624A) configured to control the flow transducer to provide a predetermined or configurable airflow and/or configured to control the pressure transducer to provide a predetermined or configurable pressure ([0083] The control unit 186A may include an input device such as one or more keyboards (one-handed or two-handed), a mouse, touch screens, voice commands and associated hardware, gesture recognition, or any other device or method of providing communication between an operator and the control unit 186A) ([0086] [0086] The control unit 186A can be configured to send control signals to open and/or close the suction valve 2620A, the gas delivery valve 2622A, the liquid delivery valve 2624A and/or the recirculation valve 238A based on changes in the human patient's or animal's airway pressure (P.sub.aw) 44A) ([0086] The predetermined threshold pressure and/or the preset vacuum can be adjusted and/or set by the user of the apparatus for example by using an input device associated with the control unit 186A).
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.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman (US 20180318543 A1) in view of Adams (US 20150335837 A1).
Regarding claim 7, Coleman teaches the portable cooling device of claim 1, but fails to teach wherein the pressure transducer is one or more piezoelectric micro blowers. However, Adams teaches wherein the pressure transducer is one or more piezoelectric micro blowers ([0015] The processing unit 20 may include additional sensors 23, which are also powered from the piezoelectric element 11, such as temperature or pressure sensors). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include wherein the pressure transducer is one or more piezoelectric micro blowers. Doing so allows for the transducer to be powered by the voltage from the piezoelectric element so that the sensor is self powered ([0015]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman (US 20180318543 A1) in view of Belson (1) (US 8402968 B2).
Regarding claim 8, Coleman teaches the portable cooling device of claim 1, the flow transducer ([0078] The gas delivery tube 232A can be connected to a gas source 60A which can provide pressurized and/or unpressurized air and/or gas to the gas delivery tube 232A. The term “gas source” is a broad term that is intended to comprise any source for pressurized and/or unpressurized air and/or gas such that the gas source 60A can comprise any of a wide variety of sources of pressurized and/or unpressurized air and/or gas such as, for example, a pressurized air and/or gas tank and/or a pump and/or compressor and/or an opening and/or connection to atmospheric air), but fails to teach wherein the flow transducer is one or more fans. However, Belson teaches wherein the flow transducer is one or more fans ([23] Optionally, a fan 14 may be included to constantly circulate the breathing gas within the system to avoid the fluid droplets and ice particles from settling out of the breathing gas). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include wherein the flow transducer is one or more fans. Doing so aids in the continuous circulation of particles and controllable airflow.
Claim(s) 10, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman (US 20180318543 A1) in view of Belson (2) (US 20120167878 A1).
Regarding claim 10, Coleman teaches the portable cooling device of claim 1, further comprising at least one pressure sensor, but fails to teach arranged to measure a pressure provided by the pressure transducer. However, Belson (2) teaches arranged to measure a pressure provided by the pressure transducer ([0045] The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include arranged to measure a pressure provided by the pressure transducer. Doing so allows for a measurement of the pressure to be regulated for a desired result by the transducer.
Regarding claim 12, Coleman teaches the portable cooling device of claim 11, wherein the controller is configured to control the pressure transducer based on measurement data from said at least one pressure sensor arranged to measure a pressure provided by the pressure transducer ([0081] As shown in FIG. 1A, the pressure sensor 400A can be operatively connected to a control unit 186A. The control unit 186A can use the information from the pressure sensor 400A to output electrical signals and/or instructions (as described below) to control the flow of the liquid and gas between the tube assembly 20A and the endotracheal tube 40A).
Coleman fails to teach wherein the controller is configured to control the flow transducer based on measurement data from said at least one flow sensor arranged to measure the airflow provided to the user.
However, Belson (2) teaches wherein the controller is configured to control the flow transducer based on measurement data from said at least one flow sensor ([0045] The dispensing of fluid should be timed to the flow of the breathing gas mixture into the patient during the inhalation portion of the patient's breathing cycle. To achieve this result, the control system can receive a sensor input that indicates when inhalation is about to occur, when it is occurring, and/or when inhalation is completing. This can be achieved by a variety of sensors 112, which may comprise pressure sensors or flow sensors) arranged to measure the airflow provided to the user ([0045] The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include wherein the controller is configured to control the flow transducer based on measurement data from said at least one flow sensor arranged to measure the airflow provided to the user. Doing so allows for the flow rate to be regulated for a desired result by the transducer.
Regarding claim 13, Coleman teaches a method of controlling the portable cooling device of claim 1, the method comprising: controlling the flow transducer to provide an airflow to the user ([0010] The apparatus can include one or more valves configured to control flow through the liquid delivery, the gas delivery and/or the suction passages when the apparatus switches between an inhale phase and an exhale phase) ([0102] Air or gas can continue to flow into the patient until a certain desired pressure is reached. The desired pressure can result from filling the lungs or compression of the lungs via manual or machine-driven CPR. The apparatus 1B can switch to the exhale phase at the desired pressure. During the exhale phase, the valve 1410B opens and the valve 1402B closes so that air or gas from the P/V pump 19 is released as exhaust into the atmosphere, or optionally to an exhaust collection device (not shown). The valve 1414B closes and the valve 1406B opens so that the reservoir 160B is under vacuum (V). The gas delivery valve 2622B also closes), wherein the flow transducer is controlled independently of the pressure transducer ([0081] The apparatus 1A can include additional sensors and/or switches such as adjustable pressure switches, vacuum sensors, adjustable vacuum switches, pressure meters, vacuum meters and/or thermometers), and controlling the pressure transducer to provide a pressure to inject the coolant into the airflow ([0081] The pressure sensor 400A can be operatively connected to a control unit 186A. The control unit 186A can use the information from the pressure sensor 400A to output electrical signals and/or instructions (as described below) to control the flow of the liquid and gas between the tube assembly 20A and the endotracheal tube 40A), wherein the pressure transducer is controlled independently of the flow transducer ([0080] The pressure sensor 400A advantageously can be configured to sense pressure change when only gas is delivered, when a mixture of gas and liquid is delivered, and/or when only liquid is delivered by the apparatus 1A).
Coleman fails to fully teach controlling the flow transducer to provide an airflow to the user. However, Belson (2) teaches controlling the flow transducer to provide an airflow to the user ([0045] the control system can receive a sensor input that indicates when inhalation is about to occur, when it is occurring, and/or when inhalation is completing. This can be achieved by a variety of sensors 112, which may comprise pressure sensors or flow sensors. The control system and sensors 112 can also record and monitor the patient's temperature using any known way of measuring a patient's temperature, such as an oral, urethral, skin, IR, or rectal probe. The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include controlling the flow transducer to provide an airflow to the user. Doing so allows for the flow rate to be regulated for a desired result by the transducer.
Claim(s) 9, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman (US 20180318543 A1) in view of Belson (2) (US 20120167878 A1) and Belson (3) (EP 2753273 B1).
Regarding claim 9, Coleman teaches the portable cooling device of claim 1, but fails to fully teach further comprising at least one flow sensor arranged to measure the airflow provided to the user.
However, Belson (2) teaches, further comprising at least one flow sensor ([0045] The dispensing of fluid should be timed to the flow of the breathing gas mixture into the patient during the inhalation portion of the patient's breathing cycle. To achieve this result, the control system can receive a sensor input that indicates when inhalation is about to occur, when it is occurring, and/or when inhalation is completing. This can be achieved by a variety of sensors 112, which may comprise pressure sensors or flow sensors) arranged to measure the airflow provided to the user ([0045] The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include comprising at least one flow sensor. Doing so allows for a measurement of the flow rate to determine if it is within a desired range.
Further, Belson (3) teaches arranged to measure the airflow provided to the user ([Pg 7, Para 1] A sensor package 106 may be used to monitor at least one of the following: patient body temperature, abdominal cavity body temperature, target organ temperature, chilled gaseous fluid flow rate, or liquid fluid introduction rate. Data measured by sensor package 106 is used may be used by a processor/controller 107 to modify the production and flow rate of the mixture 105, the flow and temperature of the gaseous fluid stream 103 in order to control the patient's temperature two within targeted therapeutic ranges). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include arranged to measure the airflow provided to the user. Doing so ensures the airflow rate is within a desired range.
Regarding claim 14, Coleman teaches the method of claim 13, wherein controlling the flow transducer further comprises: acquiring a predetermined or configurable, airflow ([0083] The control unit 186A may include an input device such as one or more keyboards (one-handed or two-handed), a mouse, touch screens, voice commands and associated hardware, gesture recognition, or any other device or method of providing communication between an operator and the control unit 186A) ([0086] [0086] The control unit 186A can be configured to send control signals to open and/or close the suction valve 2620A, the gas delivery valve 2622A, the liquid delivery valve 2624A and/or the recirculation valve 238A based on changes in the human patient's or animal's airway pressure (P.sub.aw) 44A) ([0086] The predetermined threshold pressure and/or the preset vacuum can be adjusted and/or set by the user of the apparatus for example by using an input device associated with the control unit 186A).
Coleman fails to fully teach acquiring a current airflow from at least one flow sensor arranged to measure the airflow, wherein the step of controlling the flow transducer to provide an airflow, is based on a difference between the acquired predetermined or configurable airflow and the acquired current airflow.
However, Belson (2) teaches acquiring a current airflow from at least one flow sensor arranged to measure the airflow ([0045] the control system can receive a sensor input that indicates when inhalation is about to occur, when it is occurring, and/or when inhalation is completing. This can be achieved by a variety of sensors 112, which may comprise pressure sensors or flow sensors. The control system and sensors 112 can also record and monitor the patient's temperature using any known way of measuring a patient's temperature, such as an oral, urethral, skin, IR, or rectal probe. The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include acquiring a current airflow from at least one flow sensor arranged to measure the airflow. Doing so allows for a measurement of the flow rate to determine if it is within a desired range.
Further, Belson (3) teaches wherein the step of controlling the flow transducer to provide an airflow, is based on a difference between the acquired predetermined or configurable airflow and the acquired current airflow ([Pg 7, Para 1] A sensor package 106 may be used to monitor at least one of the following: patient body temperature, abdominal cavity body temperature, target organ temperature, chilled gaseous fluid flow rate, or liquid fluid introduction rate. Data measured by sensor package 106 is used may be used by a processor/controller 107 to modify the production and flow rate of the mixture 105, the flow and temperature of the gaseous fluid stream 103 in order to control the patient's temperature two within targeted therapeutic ranges. It should be understood that the fluid stream 103 and mixture 105 may not always be introduced into the patient's abdominal cavity in a continuous fashion. If the processor/controller 107 receives data from the sensor package 106 that indicates the temperature of patient's tissues are falling below the designated therapeutic range into potentially harmful ranges then the processor/controller may alter the characteristics of the gaseous fluid stream 103 or the mixture 105 or stop or retard the flow of either the gaseous fluid stream and/or the mixture 105). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include wherein the step of controlling the flow transducer to provide an airflow, is based on a difference between the acquired predetermined or configurable airflow and the acquired current airflow. Doing so allows for a measurement of the flow rate to determine if it is within a desired therapeutic range.
Regarding claim 15, Coleman teaches the method of claim 13, wherein controlling the pressure transducer further comprises: acquiring a predetermined or configurable pressure ([0083] The control unit 186A may include an input device such as one or more keyboards (one-handed or two-handed), a mouse, touch screens, voice commands and associated hardware, gesture recognition, or any other device or method of providing communication between an operator and the control unit 186A) ([0086] [0086] The control unit 186A can be configured to send control signals to open and/or close the suction valve 2620A, the gas delivery valve 2622A, the liquid delivery valve 2624A and/or the recirculation valve 238A based on changes in the human patient's or animal's airway pressure (P.sub.aw) 44A) ([0086] The predetermined threshold pressure and/or the preset vacuum can be adjusted and/or set by the user of the apparatus for example by using an input device associated with the control unit 186A); acquiring a current pressure from at least one pressure sensor arranged to measure the pressure ([0081] The pressure sensor 400A can be operatively connected to a control unit 186A. The control unit 186A can use the information from the pressure sensor 400A to output electrical signals and/or instructions (as described below) to control the flow of the liquid and gas between the tube assembly 20A and the endotracheal tube 40A).
Coleman fails to fully teach wherein controlling the pressure transducer to provide a pressure, is based on a difference between the acquired predetermined or configurable pressure and the acquired current pressure.
However, Belson (3) teaches wherein controlling the pressure transducer to provide a pressure, is based on a difference between the acquired predetermined or configurable pressure and the acquired current pressure ([Pg 7, Para 1] A sensor package 106 may be used to monitor at least one of the following: patient body temperature, abdominal cavity body temperature, target organ temperature, chilled gaseous fluid flow rate, or liquid fluid introduction rate. Data measured by sensor package 106 is used may be used by a processor/controller 107 to modify the production and flow rate of the mixture 105, the flow and temperature of the gaseous fluid stream 103 in order to control the patient's temperature two within targeted therapeutic ranges. It should be understood that the fluid stream 103 and mixture 105 may not always be introduced into the patient's abdominal cavity in a continuous fashion. If the processor/controller 107 receives data from the sensor package 106 that indicates the temperature of patient's tissues are falling below the designated therapeutic range into potentially harmful ranges then the processor/controller may alter the characteristics of the gaseous fluid stream 103 or the mixture 105 or stop or retard the flow of either the gaseous fluid stream and/or the mixture 105). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Coleman to include wherein controlling the pressure transducer to provide a pressure, is based on a difference between the acquired predetermined or configurable pressure and the acquired current pressure. Doing so allows for a measurement of the pressure to determine if it is within a desired therapeutic range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794