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 .
Claim Objections
Claim 26 is objected to because of the following informalities: Claim 26 does not end in a period. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 24, 25, and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tyler et al (US Publication 2017/0368297).
Referring to Claim 24, Tyler et al teaches a method, comprising: sending, via an electronic device, a signal to control a controller of a headset (e.g. Paragraph [0095]); powering, via the controller, a circuit including a first electrode and a second electrode of the headset to deliver current to a user in a predetermined direction between the first electrode and the second electrode to provide transcranial stimulation (e.g. Paragraphs [0091] and [0095]); and displaying, via a display of the electronic device and while the transcranial stimulation is being provided to the user, digital content associated with a treatment program to the user (e.g. Figure 6, Element 613 and Paragraphs [0096]-[0097] and [0115]).
Referring to Claim 25, Tyler et al teaches the method of claim 24, further comprising: periodically powering, via the controller, the circuit according to a schedule for performing transcranial stimulation (e.g. Paragraphs [0091] and [0095]).
Referring to Claim 29, Tyler et al teaches the method of claim 25, further comprising: reminding, via at least one of the headset or the electronic device, the user to wear the headset based on the schedule (e.g. Paragraph [0041] discloses the wearable TES applicator transmits a notification that reminds the subject to wear the TES applicator before the scheduled time).
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.
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.
Claim(s) 16-21, and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyler et al (US Publication 2017/0368297) in view of Neuvonen et al (US Publication 2015/0190635).
Referring to Claim 16, Tyler et al teaches a method, comprising: receiving, at an electronic device, a schedule for performing transcranial stimulation (e.g. Paragraph [0093] discloses smartphone (control unit 609) used to wirelessly communicates with the wearable TES (600) which holds 2 or more electrodes and Paragraphs [0094]-[0095] discloses the wearable neurostimulator is controlled through communication to control unit 609 to communicate stimulation timing); sending, via the electronic device, a signal associated with the schedule to a controller of a headset (e.g. Paragraph [0095]); periodically powering, via the controller, a circuit including a first electrode and a second electrode of the headset to deliver current to a user to provide transcranial stimulation according to the schedule (e.g. Paragraphs [0091] and [0095]). However, Tyler et al does not disclose sending, via the electronic device, information indicative of a progress of the user to a remote device such that a physician can remotely monitor the progress of the user and adjust the schedule. Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with sending, via the electronic device, information indicative of a progress of the user to a remote device such that a physician can remotely monitor the progress of the user and adjust the schedule as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 17, Tyler et al in view of Neuvonen et al teaches the method of claim 16, further comprising: reminding, via at least one of the headset or the electronic device, the user to wear the headset based on the schedule (e.g. Paragraph [0041] discloses the wearable TES applicator transmits a notification that reminds the subject to wear the TES applicator before the scheduled time).
Referring to Claim 18, Tyler et al in view of Neuvonen et al teaches the method of claim 16, further comprising: prompting, at the electronic device, the user to input information pertaining to a status of the user (e.g. Figure 6, Element 612 discloses one or more display elements to provide feedback about a TES session). However, Tyler et al does not disclose sending, via the electronic device, the information pertaining to the status of the user to a remote device such that the physician can adjust the schedule based on the information pertaining to the status of the user.
Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with sending, via the electronic device, the information pertaining to the status of the user to a remote device such that the physician can adjust the schedule based on the information pertaining to the status of the user as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 19, Tyler et al in view of Neuvonen et al teaches the method of claim 16, except further comprising: displaying, on a display of the electronic device, instructions for positioning the headset.
Neuvonen et al teaches that it is known to use displaying, on a display of the electronic device, instructions for positioning the headset as set forth in Figure 2b and Paragraphs [0039]-0040] to provide improved treatment by improving positioning of the electrodes on the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with displaying, on a display of the electronic device, instructions for positioning the headset as taught by Neuvonen et al, since such a modification would provide the predictable results of improved treatment by improving positioning of the electrodes on the patient.
Referring to Claim 20, Tyler et al in view of Neuvonen et al teaches the method of claim 16, except further comprising: presenting, via the electronic device, information pertaining to adjustments to the schedule made by the physician.
Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with presenting, via the electronic device, information pertaining to adjustments to the schedule made by the physician as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 21, Tyler et al in view of Neuvonen et al teaches the method of claim 16, further comprising: displaying, via a display of the electronic device and while the transcranial stimulation is being provided to the user, digital content associated with a treatment program (e.g. Figure 6, Element 613).
Referring to Claim 26, Tyler et al teaches the method of claim 25, further comprising: prompting, at the electronic device, the user to input information pertaining to a status of the user (e.g. Figure 6, Element 612). However, Tyler et al does not disclose sending, via the electronic device, the information pertaining to the status of the user to a remote device such that the physician can adjust the schedule based on the information pertaining to the status of the user.
Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with sending, via the electronic device, the information pertaining to the status of the user to a remote device such that the physician can adjust the schedule based on the information pertaining to the status of the user as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 27, Tyler et al teaches the method of claim 25, except further comprising: sending, via the electronic device, information indicative of a progress of the user to a remote device such that a physician can remotely monitor the progress of the user and adjust the schedule. Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with sending, via the electronic device, information indicative of a progress of the user to a remote device such that a physician can remotely monitor the progress of the user and adjust the schedule as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 28, Tyler et al in view of Neuvonen et al teaches the method of claim 26, except further comprising: presenting, via the electronic device, information pertaining to adjustments to the schedule made by the physician.
Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with presenting, via the electronic device, information pertaining to adjustments to the schedule made by the physician as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters
Claim(s) 22-23, 30-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyler et al (US Publication 2017/0368297) in view of Neuvonen et al (US Publication 2015/0190635) and Stoler et al (US Publication 2005/0197556).
Referring to Claims 22 and 30, Tyler et al in view of Neuvonen et al teaches the method of claim 16, except wherein the headset includes: a frame supporting the first electrode and the second electrode; and a longitudinal extension coupled at one end to a center portion of the frame and configured to extend over a head of the user toward a neck of the user. Stoler et al teaches that it is known to use a frame supporting the electrode (e.g. Paragraph [0032] discloses the headband 10 comprises at least one electrode) and a longitudinal extension coupled to at one end to a center portion of the frame and configured to extend over a head of the user toward a neck of the user end as set forth in Figure 5 middle longitudinal extension to provide improved holding of the electrodes on a patient’s head which reduces the risk of the electrodes sliding down and without causing significant discomfort to the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with the headset includes: a frame supporting the first electrode and the second electrode; and a longitudinal extension coupled at one end to a center portion of the frame and configured to extend over a head of the user toward a neck of the user as taught by Stoler et al, since such a modification would provide the predictable results of improved holding of the electrodes on a patient’s head which reduces the risk of the electrodes sliding down and without causing significant discomfort to the patient.
Referring to Claims 23 and 31, Tyler et al in view of Neuvonen et al and Stoler et al teaches the method of claim 22, wherein the longitudinal extension prevents the frame from being worn in an orientation in which a direction of current delivered by the first electrode and the second electrode is reversed.
Stoler et al teaches that it is known to use wherein the longitudinal extension prevents the frame from being worn in an orientation in which a direction of current delivered by the first electrode and the second electrode is reversed as set forth in Figure 5 middle longitudinal extension to provide improved holding of the electrodes on a patient’s head which reduces the risk of the electrodes sliding down and without causing significant discomfort to the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with wherein the longitudinal extension prevents the frame from being worn in an orientation in which a direction of current delivered by the first electrode and the second electrode is reversed as taught by Stoler et al, since such a modification would provide the predictable results of improved holding of the electrodes on a patient’s head which reduces the risk of the electrodes sliding down and without causing significant discomfort to the patient.
Referring to Claim 32, Tyler et al teaches a method, comprising: presenting, via an electronic device a signal to control a controller of the headset (e.g. Paragraphs [0091] and [0095]); and powering, via the controller, a circuit including the first electrode and the second electrode to deliver current to the user to provide transcranial stimulation (e.g. Paragraphs [0091] and [0095]). However, Tyler et al does not explicitly disclose presenting, via an electronic device, instructions for positioning a headset on a head of a user such that a first electrode of the headset is positioned on a first side of a forehead of the user and a second electrode is positioned on a second side of the forehead of the user with a longitudinal extension of the headset extending over the head of the user toward a neck of the user; sending, via the electronic device and after the first electrode is positioned on the first side of the forehead of the user and the second electrode is positioned on the second side of the forehead of the user, a signal to control a controller of the headset. Neuvonen et al teaches that it is known to use presenting, via an electronic device, instructions for positioning on a head of a user such that a first electrode is positioned on a first side of a forehead of the user and a second electrode is positioned on a second side of the forehead of the user and sending, via the electronic device and after the first electrode is positioned on the first side of the forehead of the user and the second electrode is positioned on the second side of the forehead of the user, a signal to control a controller of the headset as set forth in Figure 2b and Paragraphs [0039]-0040] to provide improved treatment by improving positioning of the electrodes on the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with presenting, via an electronic device, instructions for positioning on a head of a user such that a first electrode is positioned on a first side of a forehead of the user and a second electrode is positioned on a second side of the forehead of the user and sending, via the electronic device and after the first electrode is positioned on the first side of the forehead of the user and the second electrode is positioned on the second side of the forehead of the user, a signal to control a controller of the headset as taught by Neuvonen et al, since such a modification would provide the predictable results of improved treatment by improving positioning of the electrodes on the patient.
Stoler et al teaches that it is known to use a frame supporting the electrode (e.g. Paragraph [0032] discloses the headband 10 comprises at least one electrode) and a longitudinal extension coupled to at one end to a center portion of the frame and configured to extend over a head of the user toward a neck of the user end as set forth in Figure 5 middle longitudinal extension to provide improved holding of the electrodes on a patient’s head which reduces the risk of the electrodes sliding down and without causing significant discomfort to the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with the headset includes: a frame supporting the first electrode and the second electrode; and a longitudinal extension coupled at one end to a center portion of the frame and configured to extend over a head of the user toward a neck of the user as taught by Stoler et al, since such a modification would provide the predictable results of improved holding of the electrodes on a patient’s head which reduces the risk of the electrodes sliding down and without causing significant discomfort to the patient.
Referring to Claim 33, Tyler et al in view of Neuvonen et al and Stoler et al teaches the method of claim 32, further comprising: receiving, at the electronic device, a schedule for performing transcranial stimulation (e.g. Paragraph [0093] discloses smartphone (control unit 609) used to wirelessly communicates with the wearable TES (600) which holds 2 or more electrodes and Paragraphs [0094]-[0095] discloses the wearable neurostimulator is controlled through communication to control unit 609 to communicate stimulation timing); and sending, via the electronic device, a signal associated with the schedule to the controller of a headset (e.g. Paragraph [0095]).
Referring to Claim 34, Tyler et al in view of Neuvonen et al and Stoler et al teaches the method of claim 33, except further comprising: sending, via the electronic device, information indicative of a progress of the user to a remote device such that a physician can remotely monitor the progress of the user and adjust the schedule. Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with sending, via the electronic device, information indicative of a progress of the user to a remote device such that a physician can remotely monitor the progress of the user and adjust the schedule as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 35, Tyler et al in view of Neuvonen et al and Stoler et al teaches the method of claim 33, further comprising: reminding, via at least one of the headset or the electronic device, the user to wear the headset based on the schedule (e.g. Paragraph [0041] discloses the wearable TES applicator transmits a notification that reminds the subject to wear the TES applicator before the scheduled time).
Referring to Claim 36, Tyler et al in view of Neuvonen et al and Stoler et al teaches the method of claim 33, further comprising: prompting, at the electronic device, the user to input information pertaining to a status of the user (e.g. Figure 6, Element 612 discloses one or more display elements to provide feedback about a TES session). However, Tyler et al does not disclose sending, via the electronic device, the information pertaining to the status of the user to a remote device such that the physician can adjust the schedule based on the information pertaining to the status of the user.
Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with sending, via the electronic device, the information pertaining to the status of the user to a remote device such that the physician can adjust the schedule based on the information pertaining to the status of the user as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 37, Tyler et al in view of Neuvonen et al and Stoler et al teaches the method of claim 36, except further comprising: presenting, via the electronic device, information pertaining to adjustments to the schedule made by the physician.
Neuvonen et al teaches that it is known to use a wireless communication device 118 which controls a power control unit of a transcranial stimulation system, where in the wireless communication device communicates through the internet 116 to a remote server 112 is used for monitoring and setting parameters of the transcranial stimulation system to as set forth in Figure 1 and Paragraphs [0032], [0034] and [0039] to provide improved effectiveness of therapy by adjusting parameters. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Tyler et al, with presenting, via the electronic device, information pertaining to adjustments to the schedule made by the physician as taught by Neuvonen et al, since such a modification would provide the predictable results of improved effectiveness of therapy by adjusting parameters.
Referring to Claim 38, Tyler et al in view of Neuvonen et al and Stoler et al teaches the method of claim 32, further comprising: displaying, via a display of the electronic device and while the transcranial stimulation is being provided to the user, digital content associated with a treatment program (e.g. Figure 6, Element 613).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,351,362. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 16-17, 24-25, and 32-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 12,017,062. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 16-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US Patent 12,357,811. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lowin (US Patent 9,782,602) teaches a transcranial magnetic stimulation device that is communicable with a server.
Pal et al (US Publication 2015/0005840) teaches methods and devices to modify a subject’s cognitive state by applying transdermal electrical stimulation.
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/William J Levicky/Primary Examiner, Art Unit 3796