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 .
Response to Arguments
Applicant’s arguments with respect to amended claims 1-22 and new claims 23-24 have been considered but are moot in light of the new ground of rejection necessitated by amendment presented below.
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 1-3, 5, 9-15, 18-19, 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler et al. (US 20160360990 A1).
As to claims 1 and 11, Altshuler et al. discloses a device for positioning one or more neurostimulation electrodes on a subject (Abstract) comprising: an extendable headband (Figures 1-7) comprising first and second arms ([0017]; 105 and 107; Figures 1-7) each having a proximal end and a distal end, the two arms connected to one another at the proximal ends via an extension mechanism (wider headband region, depicted as 112 in Figure 1; [0017-0020]); an electrode band (electrode support panels, depicted as 110 and 11 in Figures 1-7) having first and second ends (Figures 1-7), the first end rotatably connected (pivot locations, depicted as 108 in Figures 1 and 4-7; [0017, 0021]) to a point on the first arm (Figures 1-7; [0017, 0021]), and the second end rotatably connected (pivot locations, depicted as 108 in Figures 1 and 4-7; [0017, 0021]) to a point on the second arm (Figures 1 and 4-7; [0017, 0021]); and first and second electrodes slidably positioned on the electrode band configured to deliver neurostimulation to the subject (the first and second electrodes on the electrode band(s) are considered to be “slidably positioned” on the electrode bands since the extension members, depicted as 106, can “slide” the electrode bands into a different position and thus enable the “first and second electrodes” to be “slidably positioned on the electrode band”; Figures 1-7).
Additionally, as to claims 1 and 11 Altshuler et al. discloses arms (510 in Figures 5 and 6; [0025, 0028]) with a pivoting electrode support panel for an electrode (512, 612 in Figures 5-6; [0025]) along a path on the sagittal plane. Altshuler et al. discloses the invention substantially as claimed but does not explicitly disclose the electrode band “moves along a path on the sagittal plane” or that the additional arms are “rotatably connected to a point on the” arms of the extendable headband. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the additional electrode arms of Altshuler et al. to be rotatably connected to the arms of the headband to be moved along a path on the sagittal plane in order to provide the predictable results of modifying the device to meet specific patient therapeutic needs and requirements. Therefore, the modified Altshuler et al. would have an “electrode band having first and second ends, the first end rotatably connected to a point on the first arm, and the second end rotatably connected to a point on the second arm, wherein the electrode band moves along a path on the sagittal plane”.
As to claim 2, the modified Altshuler et al. discloses the headband comprises telescopically inter-engaged components (extension members, depicted as 106 in Figures 1-2 and 4-7).
As to claim 3, the modified Altshuler et al. discloses the first and second electrodes are pad electrodes or bare electrodes (Figure 1).
As to claim 5, the modified Altshuler et al. discloses the anode is positioned in proximity to a first position on the head of the subject, and the cathode is positioned in proximity to a second position on the head of the subject ([0024, 0030]).
As to claims 6, 12 and 22, the modified Altshuler et al. discloses the invention substantially as claimed with the electrodes engaging with the forehead and prefrontal cortex ([0008]), but does not explicitly disclose the electrodes are positioned over the right and left dorsolateral prefrontal cortex. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of the electrodes of Altshuler et al. to be over the left dorsolateral prefrontal cortex, and the second position is the right dorsolateral prefrontal cortex in order to provide the predictable results of optimizing treatment, and thus electrode locations, to meet specific patient therapeutic needs and requirements. Furthermore, it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (see MPEP 2144.04)
As to claim 9, the modified Altshuler et al. discloses electrodes connect to a neurostimulator device ([0003-0004, 0022]).
As to claim 10, the modified Altshuler et al. discloses a computing device with a power source ([0018-0019, 0022, 0031]).
As to claim 13, Altshuler et al. discloses the neuromodulation or neurostimulation comprises a transcranial direct current stimulation (tDCS) ([0022]).
As to claim 14, the Altshuler et al. discloses the invention substantially as claimed but does not explicitly disclose the “tDCS comprises an applied current of 1-6 mA for a duration of 1-45 minutes”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the treatment parameters of Altshuler et al. to include tDCS an applied current of 1-6 mA for a duration of 1-45 minutes in order to provide the predictable results of modifying the treatment parameters to meet specific patient therapeutic needs and requirements.
As to claim 15, Altshuler et al. discloses the stimulus comprises an audio or visual stimulus ([0022]).
As to claim 18, Altshuler et al. discloses adjusting at least one dimension of the head-mounted device to conform to the size of the subject's head ([0017-0022]).
As to claim 19, the modified Altshuler et al. discloses positioning the first and second electrodes on the head of the subject (Figures 1-7; [0017-0022]); and providing neuromodulation or neurostimulation to the subject via the first and second electrodes ([0003-0005, 0018, 0022]).
As to claim 21, the modified Altshuler et al. discloses the first electrode is positioned in proximity to a first position on the head of the subject, and the second electrode is positioned in proximity to a second position on the head of the subject (Figures 1-7).
As to claim 22, the modified Altshuler et al. discloses the invention substantially as claimed but does not explicitly disclose the positions. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the positions to meet specific patient therapeutic needs and requirements.
As to claim 23, the modified Altshuler et al. discloses the invention substantially as claimed but does not explicitly disclose the extension mechanism adjusts a width of the device on the frontal plane. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the width to meet specific patient therapeutic needs and requirements.
As to claim 24, the modified Altshuler et al. discloses the invention substantially as claimed but does not explicitly disclose the first and second electrodes are slideable relative to the electrode band. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the positions to meet specific patient therapeutic needs and requirements.
Claims 7-8, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the modified Altshuler et al. (US 20160360990 A1) in view of Goodall et al. (US 20180168905 B2).
As to claims 7, 16 and 20, Altshuler et al. discloses the device substantially as claimed but does not explicitly disclose the “stimulus to the subject to encourage physical activity” Goodall et al. discloses “Neural stimulation is used to enhance learning or memory of a desired activity or skill, and, in some cases, block learning of an undesired activity. In an aspect, a “desired activity” is correct performance of a task, and an “undesired activity” is incorrect performance of a task, for example, a mental or physical (motor) task”([0056; 0053-0056]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation of Altshuler et al. to include “neural stimulation is used to enhance learning or memory of a desired activity or skill” as disclosed by Goodall et al. in order to provide the predictable results of optimizing treatment to meet specific patient therapeutic needs and requirements.
As to claim 8, the modified Altshuler et al. discloses an activity sensor configured to track the activity of the subject (Goodall et al., [0068, 0073-0075]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796