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 apparatus, the computer system comprising a display, one or more processors, a memory, and one or more programs 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 Objections
Claims 7, 9, and 10 objected to because of the following informalities:
Claim 7 appears to be written in an independent form, yet also refers back to the other independent claim 1. In an interpretation, claim 7 may be construed as an independent claim; and in another interpretation it may also be construed as a dependent claim. In order to prevent any foreseeable ambiguity, it is suggested to bring the entire claim 1 in to the claim 7 to have the claim construed as a proper independent claim; or, correct the dependency of the claim 7 (as shown in other depending claims e.g., claim 6, claim 2, etc.) to have the claim construed as a proper dependent claim.
Appropriate correction is required.
Claim 9 appears to be written in an independent form, yet also refers back to the other independent claim 1. In an interpretation, claim 9 may be construed as an independent claim; and in another interpretation it may also be construed as a dependent claim. In order to prevent any foreseeable ambiguity, it is suggested to bring the entire claim 1 in to the claim 9 to have the claim construed as a proper independent claim; or, correct the dependency of the claim 9 (as shown in other depending claims e.g., claim 6, claim 2, etc.) to have the claim construed as a proper dependent claim.
Appropriate correction is required.
Claim 10 appears to be written in an independent form, yet also refers back to the other independent claim 1. In an interpretation, claim 10 may be construed as an independent claim; and in another interpretation it may also be construed as a dependent claim. In order to prevent any foreseeable ambiguity, it is suggested to bring the entire claim 1 in to the claim 10 to have the claim construed as a proper independent claim; or, correct the dependency of the claim 10 (as shown in other depending claims e.g., claim 6, claim 2, etc.) to have the claim construed as a proper dependent claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, lines 5-6 of claim 2 recite “the at least one element for increasing progressively and automatically the acoustic power level of the apparatus”. However claim 2 is dependent on claim 1 which recites “at least one said control element displayed in the third area is configured for increasing progressively and automatically the acoustic power level of the apparatus”. Therefore it is unclear if the at least one element for increasing of claim 2 is the same or different from the at least one said control element configured for increasing. For examination purposes lines 5-6 of claim 2 will be interpreted as “the at least one said control element for increasing progressively and automatically the acoustic power level of the apparatus”. Claim 3 is also rejected due to it’s dependency.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Heijman (WO2019042856) and further in view of Cannata (US 20200164231) and Cesa (US 20200367963).
Regarding claim 1, Heijman discloses a computer-implemented method for controlling the operation of an apparatus able to produce ultrasound waves focused inside a target and to obtain at least one image of the target (pg. 10 lines 3-5 – “Furthermore, aspects of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer executable code embodied thereon”, pg. 8 lines 7-8 – “reconstructing a thermal map of the imaging zone using the magnetic resonance thermometry data”, Abstract – “controlling the ultrasonic transducer to sonicate the multiple sonication volumes”, pg. 21 lines 15-16 – “The acoustical absorption of the tissue/tumor, which is unknown, will determine if the power is sufficient to reach hyperthermia in the target region”), the method comprising:
displaying, on the display a user interface (pg. 5 line 12 – “render a graphical user interface on the display”) including at least:
a first area displaying at least one image of the target (Fig. 2, pg. 5 lines 21-23 – “The combination of the thermal map on the display in conjunction with the power adjustment control and the at least one button for generating the pause command and/or the resume command”),
a second area displaying a control element for activating or stopping the production of ultrasound waves by the apparatus (Fig. 2, pg. 5 lines 21-23 – “The combination of the thermal map on the display in conjunction with the power adjustment control and the at least one button for generating the pause command and/or the resume command”),
a third area displaying a current acoustic power level emitted by the apparatus, the determined range of allowed acoustic power levels and at least one control element for selecting any acoustic power level within the range of allowed acoustic power levels (Fig. 2, pg. 5 lines 21-23 – “The combination of the thermal map on the display in conjunction with the power adjustment control and the at least one button for generating the pause command and/or the resume command”),
wherein at least one said control element displayed in the third area is configured for increasing […] automatically the acoustic power level of the apparatus by selection of a higher value (pg. 12 lines 25-27 – “the user interface may allow an operator to control or manipulate a computer and the interface may allow the computer indicate the effects of the operator's control or manipulation”, pg. 2 lines 20-22 – “providing an additional control for the physician, to send a command to the HIFU system to increase or decrease the power level”);
while displaying the user interface, detecting at least one activation of any control element of the user interface by a user (pg. 13 lines 8-9 – “A 'display' or 'display device' as used herein encompasses an output device or a user interface”, pg. 12 lines 25-27 – “In other words, the user interface may allow an operator to control or manipulate a computer and the interface may allow the computer indicate the effects of the operator's control or manipulation”), and
transmitting at least one instruction to the apparatus, wherein the instruction corresponds to the at least one activation of any control element of the user interface (pg. 12 lines 25-27 – “In other words, the user interface may allow an operator to control or manipulate a computer and the interface may allow the computer indicate the effects of the operator's control or manipulation”).
Conversely Heijman does not teach determining or receiving from a user and/or a memory a range of allowed acoustic power levels for the apparatus as a function of the target and at least one configuration parameter of the apparatus;
increasing progressively and automatically the acoustic power level of the apparatus […], the progressive and automatic evolution following a predetermined speed law;
However Cannata discloses determining or receiving from a user and/or a memory a range of allowed acoustic power levels for the apparatus as a function of the target and at least one configuration parameter of the apparatus (Fig. 17 D shows the amount of voltage being applied dependent upon the target tissue depth, [0246] – “FIG. 17D illustrates one example of a Therapy: Cooling Treatability Matrix or look-up table, which can be used during therapy to determine the appropriate treatment and cooling parameters”);
Cannata is an analogous art considering it is in the field of heating tissue using ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the range of allowed acoustic power levels as a function of the target of Cannata to achieve the same results. One would have motivation to combine “to prevent or reduce thermal injury to non-targeted tissue sites” (Cannata [0246]).
Conversely Heijman and Cannata do not teach increasing progressively and automatically the acoustic power level of the apparatus […], the progressive and automatic evolution following a predetermined speed law;
However Cesa discloses increasing progressively and automatically the acoustic power level of the apparatus […], the progressive and automatic evolution following a predetermined speed law ([0074] – “ramping up the temperature of the tissue via the generator 102 through the energy delivery device 192…the temperature of the tissue may be maintained at the predetermined threshold temperature as a function of at least one of a power ramp rate”, [0049] – “the generator 102 is a radio frequency (RF) generator, but may optionally be any energy source that may deliver other forms of energy, including but not limited to…ultrasound and optical energy);
Cesa is an analogous art considering it is in the field of heating tissue using ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the progressive increase of power of Cesa to achieve the same results. One would have motivation to combine because it would allow for the system top safely reach the threshold temperature and maintain the threshold temperature.
Regarding claim 2, Heijman, Cannata, and Cesa disclose all the elements of the claimed invention as cited in claim 1.
Heijman further discloses wherein at least one said control element displayed in the third area is configured for decreasing […] automatically the acoustic power level of the apparatus by selection of a lower value (pg. 12 lines 25-27 – “the user interface may allow an operator to control or manipulate a computer and the interface may allow the computer indicate the effects of the operator's control or manipulation”, pg. 2 lines 20-22 – “providing an additional control for the physician, to send a command to the HIFU system to increase or decrease the power level”) […], such control element being the same or a different element from the at least one element for increasing progressively and automatically the acoustic power level of the apparatus (Fig. 2, pg. 18 line 33-pg. 19 line 1 – “The graphical user interface 176 further comprises a power adjustment slider 202 for receiving the change power command”).
Conversely Heijman does not teach decreasing progressively and automatically the acoustic power level of the apparatus […], the progressive and automatic evolution following a predetermined speed law;
However Cesa discloses decreasing progressively and automatically the acoustic power level of the apparatus […], the progressive and automatic evolution following a predetermined speed law ([0074] – “the temperature of the tissue may be maintained at the predetermined threshold temperature as a function of at least one of a power ramp rate”, [0049] – “the generator 102 is a radio frequency (RF) generator, but may optionally be any energy source that may deliver other forms of energy, including but not limited to…ultrasound and optical energy);
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the progressive increase of power of Cesa to achieve the same results. One would have motivation to combine because it would allow for the system to safely decrease the threshold and maintain the threshold temperature.
Regarding claim 7, Heijman discloses a computer system in communication with an apparatus, the apparatus being able to produce ultrasound waves focused inside a target and to obtain at least one image of the target, the computer system comprising: a display, one or more processors, a memory, and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the one or more programs including instructions for performing, when executed by the computer system (pg. 17 lines 17-22 – “The magnetic field gradient coil power supply 112, the high-intensity focused ultrasound system 122, and the transceiver 116 are shown as being connected to a hardware interface 172 of a computer system 170. The computer system 170 also comprises a processor 174. The processor 174 may actually represent more than one processor and may also represent processors distributed amongst one or more computers. The processor 174 is in communication with the hardware interface 172, a user interface 176, and a memory 178”, pg. 5 line 12 – “render a graphical user interface on the display”, pg. 11 lines 14-15 – “Computer executable code may comprise machine executable instructions or a program which causes a processor to perform an aspect of the present invention”), a method for controlling the operation of the apparatus according to claim 1 (As cited above Heijman, Cannata, and Cesa can be combined to teach claim 1).
Regarding claim 9, Heijman discloses a computer program product, stored on a non-transitory computer-readable data-storage medium comprising computer-executable instructions to cause a computer system to carry out a method for controlling the operation of the apparatus (pg. 8 lines 20-22 – “the invention provides for a computer program product comprising machine-executable instructions for execution by a processor controlling a medical instrument”, pg. 10 lines 3-5 – “aspects of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer executable code embodied thereon”) according to claim 1 (As cited above Heijman, Cannata, and Cesa can be combined to teach claim 1).
Regarding claim 10, Heijman discloses a non-transitory computer-readable data-storage medium containing computer-executable instructions to cause a computer system to carry out a method for controlling the operation of the apparatus (pg. 10 lines 3-5 – “aspects of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer executable code embodied thereon”, pg. 10 lines 10-11 – “The computer-readable storage medium may be referred to as a computer-readable non-transitory storage medium”) according to claim 1 (As cited above Heijman, Cannata, and Cesa can be combined to teach claim 1).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Heijman (WO 2019042856), Cannata (US 20200164231), and Cesa (US 20200367963) as applied to claim 2 above, and further in view of Highsmith (US 20170105783).
Regarding claim 3, Heijman, Cannata, and Cesa disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Heijman does not teach wherein the progressive and automatic evolution of the acoustic power level of the apparatus follows a first speed law when increasing and a second speed law when decreasing, the first and the second speed laws being different.
However Cesa discloses wherein the progressive and automatic evolution of the acoustic power level of the apparatus follows a first speed law when increasing ([0074] – “ramping up the temperature of the tissue via the generator 102 through the energy delivery device 192…the temperature of the tissue may be maintained at the predetermined threshold temperature as a function of at least one of a power ramp rate”, [0049] – “the generator 102 is a radio frequency (RF) generator, but may optionally be any energy source that may deliver other forms of energy, including but not limited to…ultrasound and optical energy);
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the progressive increase of power following a ramp rate of Cesa to achieve the same results. One would have motivation to combine because it would allow for the system to safely reach the threshold temperature and maintain the threshold temperature.
Conversely Heijman and Cesa do not teach wherein the progressive and automatic evolution of the acoustic power level of the apparatus follows […] a second speed law when decreasing, the first and the second speed laws being different.
However Highsmith discloses wherein the progressive and automatic evolution of the acoustic power level of the apparatus follows […] a second speed law when decreasing, the first and the second speed laws being different ([0078] – “the ablation power supply may take the form of, for example, an ultrasound ablation power source”, Abstract – “control a power supplied to each violating electrode to have a reduced power…detect a rate of power reduction for each violating electrode, and stop the power supplied to each violating electrode when a respective detected rate of power reduction exceeds a threshold rate of power reduction”, because the rate of Highsmith is specifically a reduction rate it would be obvious to one with ordinary skill in the art for the ramp rate of Cesa to be different from the power reduction rate of Highsmith).
Highsmith is an analogous art considering it is in the field of heating tissue using ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the progressive decrease of power according to a rate of reduction of Highsmith to achieve the same results. One would have motivation to combine because it may “reduce the risk of undesirable damage” (Highsmith [0010]).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Heijman (WO2019042856), Cannata (US 20200164231), and Cesa (US 20200367963) as applied to claim 1 above, and further in view of Barthe (US 20110112405).
Regarding claim 4, Heijman, Cannata, and Cesa disclose all the elements of the claimed invention as cited in claim 1.
Heijman further discloses wherein the apparatus comprises a power amplifier (pg. 2 lines 21-22 – “send a command to the HIFU system to increase or decrease the power level”, one with ordinary skill in the art would recognize a power amplifier would be required to increase the power level) and wherein the range of allowed acoustic power levels is further adapted according to the temperature (pg. 5 lines 27-29 – “the high-intensity focused ultrasound system could have its maximum power limited or the thermal imaging could be used to automatically reduce the power if it goes outside of the temperature range”) […].
Conversely Heijman does not teach the temperature of the power amplifier.
However Barthe discloses the temperature of the power amplifier ([0112] – “The RF driver 352 can provide power to the transducer”, [0125] – “safety features may be included such as thermal monitoring…monitoring the temperature of the RF driver 352”, [0095] – “the CTS 20 has built into the controller 300 limits as to an amount of energy 50 that can be emitted from the emitter-receiver module 200. These limits can be determined by…a temperature”).
Barthe is an analogous art considering it is in the field of treating tissue using ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the monitoring of the temperature of the power amplifier of Barthe to achieve the same results. One would have motivation to combine because “such temperature monitoring assures that the devices described operate within temperatures that are acceptable” (Barthe [0125]).
Regarding claim 5, Heijman, Cannata, Cesa, and Barthe disclose all the elements of the claimed invention as cited in claims 1 and 4.
Conversely Heijman does not teach wherein a threshold of temperature for the power amplifier is predetermined and wherein the user interface displays a first alert when the threshold of temperature is close and/or a second alert when the threshold of temperature is exceeded.
However Cesa discloses wherein the user interface displays a first alert when the threshold of temperature is close and/or a second alert when the threshold of temperature is exceeded ([0096] – “In some embodiments, an alarm and/or warning window 220 may be displayed within a channel control region 143 to indicate an unsatisfactory condition with the associated treatment procedure. For example, the controller 103 may be configured to detect when an operating parameter (e.g., an actual temperature, impedance, power output, etc.) has exceeded a threshold”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the alert when the threshold of temperature is exceeded of Cesa to achieve the same results. One would have motivation to combine because it would allow one to make corrections to operating parameters to limit damage to the tissue.
Conversely Heijman and Cesa do not teach wherein a threshold of temperature for the power amplifier is predetermined […].
However Barthe discloses wherein a threshold of temperature for the power amplifier is predetermined ([0112] – “The RF driver 352 can provide power to the transducer”, [0125] – “safety features may be included such as thermal monitoring…monitoring the temperature of the RF driver 352”, [0084] – “raising a temperature within a treatment area of the region of interest to the desired level”, [0095] – “the CTS 20 has built into the controller 300 limits as to an amount of energy 50 that can be emitted from the emitter-receiver module 200. These limits can be determined by…a temperature”, [0139] – “Treating through localized heating of regions of the SMAS 507 layer or other suspensory subcutaneous tissue 510 to temperatures of about 60° C. to about 90° C”) […].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the threshold of temperature for the power amplifier of Barthe to achieve the same results. One would have motivation to combine because “such temperature monitoring assures that the devices described operate within temperatures that are acceptable” (Barthe [0125]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Heijman (WO 2019042856), Cannata (US 20200164231), and Cesa (US 20200367963) as applied to claim 1 above, and further in view of Puleo (US 20220126121).
Regarding claim 6, Heijman, Cannata, and Cesa disclose all the elements of the claimed invention as cited in claim 1.
Conversely Heijman does not teach wherein the user interface displays a cumulated dose corresponding to the cumulated focused waves produced by the apparatus at the target site and wherein the range of allowed acoustic power levels is further adapted according to a predetermined maximum cumulated dose.
However Cannata discloses wherein the range of allowed acoustic power levels is further adapted according to a predetermined maximum cumulated dose (Table 4 shows three treatment schemes with the Dose [predetermined maximum cumulated dose] and the power supply setting for each treatment scheme).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the acoustic power levels adapted according to the maximum cumulated dose of Cannata to achieve the same results. One would have motivation to combine to prevent or reduce thermal injury once the maximum dosage has been met.
Conversely Heijman and Cannata do not teach wherein the user interface displays a cumulated dose corresponding to the cumulated focused waves produced by the apparatus at the target site.
However Puleo discloses wherein the user interface displays a cumulated dose corresponding to the cumulated focused waves produced by the apparatus at the target site ([0089] – “FIG. 25 shows an embodiment in which the controller 16 provides an indicator via the display 36 relating to the total dose. For example, a shape may fill in as the dose is accumulating. Further, the display 36 may provide a user interface that indicates that the energy application device 12 is correctly positioned to provide the dose to the region of interest 44”).
Puleo is an analogous art considering it is in the field of treating tissue using ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Heijman to incorporate the display of cumulated dose of Puleo to achieve the same results. One would have motivation to combine because it would allow one to visualize the progress of the treatment.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Heijman (WO 2019042856), Cannata (US 20200164231), and Cesa (US 20200367963) as applied to claim 7 above, and further in view of Qingyu (CN106198360A) machine translation.
Regarding claim 8, Heijman, Cannata, and Cesa disclose all the elements of the claimed invention as cited in claim 7.
Heijman further discloses wherein the display comprises a touch-sensitive surface and the user interface is displayed on the touch-sensitive surface (pg. 17 lines 25-27 – “The user interface 176 may for example be a display and comprise a means for interacting with a graphical user interface rendered on the display. This may include the display being a touch screen”),
Conversely Heijman does not teach the touch-sensitive surface being able to detect intensities of contacts with the touch-sensitive surface.
However Qingyu discloses the touch-sensitive surface being able to detect intensities of contacts with the touch-sensitive surface ([0031] – “The touch panel includes one or more touch sensors to sense touches, swipes, and gestures on the touch panel. The touch sensor can not only sense the boundaries of a touch or swipe action, but also detect the duration and pressure associated with the touch or swipe operation”).
Qingyu is an analogous art considering it is in the field of a tissue treatment system with a touch screen for user input.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computer system of Heijman to incorporate the touch-sensitive surface being able to detect intensities of contacts of Qingyu to achieve the same results. One would have motivation to combine because it would allow the system to detect a duration and pressure of a touch so that accidental touches to the screen do not cause inputs that may be unsafe.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797