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 claim 64 (and dependent claims 68-73) and new claims 74-79 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102/103
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 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.
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 64, 68 and 71-73 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Errico et al. (US Patent Publication 20150073505 A1).
As to claim 64, Errico et al. discloses a system for generating arousal-linked neuromodulation of sensory processing (Abstract) comprising: a transcutaneous vagus nerve stimulator configured to generate arousal-linked neuromodulation of sensory processing ([0129-0143]), wherein the transcutaneous vagus nerve stimulator includes at least two electrodes ([0093-0095, 0110-0118]); and an alignment guide (the position-indicating fluorescent spots, [0131-0139, 0143]) is configured to guide a user to position the transcutaneous vagus nerve stimulator over a subject's vagus nerve ([0143]), wherein the transcutaneous vagus nerve stimulator is shaped to fit within the alignment guide ([0142-0143, 0174-0176]). Thus, based on the location of the treatment area ([0162-0166]; Figures 8-10) and the associated fluorescent spots (alignment guide), the examiner considers the alignment guide of Errico et al. to be shaped and dimensioned such that its edges align with a subject’s carotid triangle.
In the alternative, although the examiner considers Errico et al. to disclose the alignment guide to be shaped and dimensioned such that its edges align with a subject’s carotid triangle, Errico et al. does not explicitly disclose the alignment guide is “shaped and dimensioned such that its edges align with a subject’s carotid triangle”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the locations of the alignment guide (fluorescent spots) to be “shaped and dimensioned such that its edges align with a subject’s carotid triangle” in order to provide the predictable results of ensuring proper positioning and placement of the stimulation device for accurate treatment of the target location.
As to claim 68, Errico et al., and thus the modified Errico et al., disclose the transcutaneous vagus nerve stimulator comprises a grid of electrodes ([0093, 0110], 2 electrodes adjacent to each other is a 1x2 grid or a 2x1 grid depending on the orientation).
As to claim 71, Errico et al., and thus the modified Errico et al., disclose the transcutaneous vagus nerve stimulator comprises a grid of electrodes ([0093, 0110], 2 electrodes adjacent to each other is a 1x2 grid or a 2x1 grid depending on the orientation), and wherein the transcutaneous vagus nerve stimulator is configured to identify electrodes within the grid that are nearest to the subject's vagus nerve using closed-loop feedback (The stimulator uses illumination from the position indicating fluorescent spots to determine when the electrodes are positioned near the subject’s vagus nerve. Therefore, the imaging of the fluorescent dye functions as closed-loop feedback to identify when the electrodes, within the grid, are near the subject’s vagus nerve; [0129, 0137-0140]).
As to claim 72, Errico et al., and thus the modified Errico et al., disclose the alignment guide is generated by imaging a portion of the subject's body ([0129, 0137-0140]).
As to claim 73, Errico et al., and thus the modified Errico et al., disclose the alignment guide (the position-indicating fluorescent spots) and the transcutaneous vagus nerve stimulator are mutually configured so that the alignment guide can be removed from the transcutaneous vagus nerve stimulator after the transcutaneous vagus nerve stimulator has been applied to a subject's body (i.e., when the transcutaneous vagus nerve stimulator is removed from the patient’s body after stimulation treatment, “the alignment guide” is separated or “removed” from the transcutaneous vagus nerve stimulator after the transcutaneous vagus nerve stimulator has completed treatment and is separated from a subject's body).
Claims 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al. (US Patent Publication 20150073505 A1), or the modified Errico et al. as applied to claims 64, 68 and 71-73 above.
As to claim 69, Errico et al., and the modified Errico et al., discloses employing sensors for monitoring feedback signals from the patient ([0038, 0099, 0106, 0186-0187]) as well as sensing optical feedback through imaging of fluorescent position markers to locate the vagus nerve ([0032, 0038, 0137-0143]). Errico et al., and the modified Errico et al., discloses the invention substantially as claimed by sensing feedback that is used to located the subject’s vagus nerve but does not explicitly discloses that the feedback is “feedback provided by the electrodes”. Dual function sensing and stimulating electrodes are extremely well known in the electrical stimulation art. As such, modifying the sensors in Errico et al., and the modified Errico et al., to be sensors consisting of sensing electrodes would have been obvious to one having ordinary skill in the art at the time the invention was made since the examiner takes Official Notice of the equivalence of sensors and sensing electrodes for their use in the medical diagnostics and medical stimulation art and the selection of either of these known equivalents to sense physiological signals would be within the level of ordinary skill in the art. (See MPEP 2144.06). Feedback provided by the sensors is used to set or optimize stimulation to the vagus nerve ([0186]). As a result, the Errico et al., and the modified Errico et al., would verify the vagus nerve is being stimulated at the proper location to maximize therapeutic benefits to the patient. Therefore, the modified Errico et al., with sensors that comprise sensing electrodes, would employ (sensing) electrodes that sense feedback that is used to located the subject’s vagus nerve.
As to claim 70, the modified Errico et al. discloses sensing electrodes for monitoring physiological measurements such as heart rate and blood pressure ([0187]) but does not explicitly disclose sensing “the pumping of blood through the carotid artery”. It would have been obvious to one having ordinary skill at the time the invention was made to modify the location of the hemodynamic sensing electrodes of the modified Errico et al. in order to provide the predictable results of modifying the sensed physiological data to provide diagnostics and treatment to meet specific patient therapeutic needs and requirements.
Claims 74-76 are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al. (US Patent Publication 20150073505 A1) in view of Gerber et al. (US 20120277621 A1).
As to claim 74, Errico et al. discloses a system for generating arousal-linked neuromodulation of sensory processing (Abstract) comprising: a transcutaneous vagus nerve stimulator configured to generate arousal-linked neuromodulation of sensory processing ([0129-0143]), wherein the transcutaneous vagus nerve stimulator includes a gird of electrodes ([0093-0095, 0110-0118]; As to claim 68, Errico et al., and thus the modified Errico et al., disclose the transcutaneous vagus nerve stimulator comprises a grid of electrodes ([0093, 0110]; 2 electrodes adjacent to each other is a 1x2 grid or a 2x1 grid depending on the orientation); and an alignment guide (the position-indicating fluorescent spots, [0131-0139, 0143]) is configured to guide a user to position the transcutaneous vagus nerve stimulator over a subject's vagus nerve ([0143]).
Errico et al. discloses the device substantially as claimed with a grid of electrodes, but does not explicitly disclose the “grid of electrodes that includes a plurality of rows and a plurality of columns” or that “the transcutaneous vagus nerve stimulator is configured to identify which of the electrodes within the grid should be used for stimulation”. Gerber et al. discloses a grid of electrodes (Figure 12; [0152]) and a stimulator that “identify which of the electrodes within the grid should be used for stimulation” ([0152]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the grid of electrodes of Errico et al. to include a plurality of rows and a plurality of columns, as disclosed by Gerber et al. since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 (see MPEP 2144.04). Furthermore, such a modification would provide the predictable results of increasing electrode presence for ensuring more precise engagement with the treatment target location.
Additionally, Errico et al. discloses the invention substantially as claimed but does not explicitly disclose the stimulator is used to identify which of the electrodes within the grid should be used for stimulation. Gerber et al. discloses the stimulator is used to “identify which of the electrodes within the grid should be used for stimulation” ([0152]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulator of Errico et al. to identify which of the electrodes within the grid should be used for stimulation as disclosed by Gerber et al. in order to provide the predictable results of optimizing electrode position and location for addressing the treatment target in order to meet specific patient therapeutic needs and requirements.
As to claim 75, the modified Errico et al. discloses the transcutaneous vagus nerve stimulator identifies which of the electrodes within the grid should be used for stimulation using closed-loop feedback in response to stimulation (Gerber et al., [0057, 0152]).
As to claim 76, the modified Errico et al. discloses the transcutaneous vagus nerve stimulator tests stimulation across different pairs of the electrodes within the grid while measuring a level of neuromodulation that is induced for each stimulation to determine which pair of electrodes induces the strongest neuromodulation (Gerber et al., [0152]).
Claims 77-79 are rejected under 35 U.S.C. 103 as being unpatentable over the modified Errico et al., as applied to claims 74-76 above, in further view of Johnson et al. (US 20140164056 A1).
As to claim 77, the modified Errico et al. discloses the invention substantially as claimed but does not explicitly disclose “the level of neuromodulation that is induced for each stimulation is determined by measuring a degree of pupil dilation that is caused by each stimulation”. Johnson et al. discloses biosensors for recording pupil dialation for identifying patient’s response to stimuli ([0041]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensors of the modified Errico et al. to include a sensor to measure a degree of pupil dilation as disclosed by Johnson et al. in order to provide the predictable results of collecting a variety of patient data for the optimization of patient treatment in order to meet specific patient therapeutic needs and requirements.
As to claim 78, the modified Errico et al. discloses the alignment guide is shaped and dimensioned such that its edges align with a subject's carotid triangle, based on the location of the treatment area (Errico et al., [0162-0166]; Figures 8-10) and the associated fluorescent spots (alignment guide), the examiner considers the alignment guide of Errico et al., and thus the modified Errico et al., to be shaped and dimensioned such that its edges align with a subject’s carotid triangle with the transcutaneous vagus nerve stimulator is shaped to fit within the alignment guide.
In the alternative, although the examiner considers Errico et al., and thus the modified Errico et al., to disclose the alignment guide to be shaped and dimensioned such that its edges align with a subject’s carotid triangle, the modified Errico et al. does not explicitly disclose the alignment guide is “shaped and dimensioned such that its edges align with a subject’s carotid triangle”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the locations of the alignment guide (fluorescent spots) to be “shaped and dimensioned such that its edges align with a subject’s carotid triangle” in order to provide the predictable results of ensuring proper positioning and placement of the stimulation device for accurate treatment of the target location.
As to claim 79, the modified Errico et al. disclose the alignment guide (the position-indicating fluorescent spots) and the transcutaneous vagus nerve stimulator are mutually configured so that the alignment guide can be removed from the transcutaneous vagus nerve stimulator after the transcutaneous vagus nerve stimulator has been applied to a subject's body (i.e., when the transcutaneous vagus nerve stimulator is removed from the patient’s body after stimulation treatment, “the alignment guide” is separated or “removed” from the transcutaneous vagus nerve stimulator after the transcutaneous vagus nerve stimulator has completed treatment and is separated from a subject's body).
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