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 claims 1-4 and 6-11 have been considered but are moot because the new ground necessitated by amendment. The rejection of the pending claims 1-4 and 6-11 are detailed 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 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 20160279023 A1).
As to claim 1, Hyde et al. discloses a vagus nerve stimulator having at least two electrodes that are configured to be worn on at least one of the left and right ears and are configured to generate electrical stimulation on the vagus nerve in the auricle (Figures 3-6), the vagus nerve stimulator ([0103]) comprising: a body part (securing member, depicted as 500 in Figure 5) configured to be located on a side of a wearer's ear (Figures 3-6); a first electrode configured to be inserted into and make contact with the external acoustic meatus of the wearer's ear (Figure 5; [0072-0073]; “A neural stimulator 510 may be positioned on earpiece 502a, as shown, or alternatively (or in addition) on ear canal extension 508a”. Thus Hyde et al. discloses a first electrodes which is the additional electrode at 508a which makes contact with the external acoustic meatus); a second electrode configured to make contact with the cymba concha of the wearer's ear (Figure 5; [0072-0073]); a first electrode fixing part (depicted as 508a in Figure 5) protruding from the body part and having a first electrode at an end thereof (Figure 5; [0073]); and a second electrode fixing part (depicted as 502a in Figures 5) protruding from the body part and having a second electrode at an end thereof (Figure 5; [0073]), wherein when a protruding direction of the first electrode fixing part coincides with the x-axis of a three-dimensional coordinate system, an angle between a protruding direction of the second electrode fixing part and the protruding direction of the first electrode fixing part is in a range of 10° to 20° on the xz plane and in a range of 35° to 45° on the xy plane (Figure 5).
Additionally, Hyde et al. discloses the device substantially as claimed but is silent as to the protruding length of the second electrode fixing part from the body part. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the protruding length of the first electrode fixing part from the body part to be 5 mm in order to provide the predictable results of modifying the device construction to customize the device to accommodate individual structural needs and meet specific patient therapeutic needs and requirements. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05).
As to claim 2, the modified Hyde et al. discloses the invention substantially as claimed with an angle between the protruding direction of the second electrode fixing part and the protruding direction of the first electrode fixing part but does not explicitly disclose the angle is 14.8±2° on the xz plane and 39.7±2° on the xy plane. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the angle between the protruding direction of the second electrode fixing part and the protruding direction of the first electrode fixing part in order to provide the predictable results of modifying the device construction to customize the device to accommodate individual structural needs and meet specific patient therapeutic needs and requirements. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05).
As to claim 3, the modified Hyde et al. discloses the invention substantially as claimed but does not explicitly disclose an interval between a position where the first electrode fixing part protrudes from the body part and a position where the second electrode fixing part protrudes from the body part is 14.5±2 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify an interval between a position where the first electrode fixing part protrudes from the body part and a position where the second electrode fixing part protrudes from the body part to be 14.5±2 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of ensuring customization of the device to accommodate individual structural needs and meet specific patient therapeutic needs and requirements.
As to claim 4, the modified Hyde et al. discloses the device substantially as claimed but is silent as to the protruding length of the first electrode fixing part from the body part. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the protruding length of the first electrode fixing part from the body part is equal to or larger than 6 mm in order to provide the predictable results of modifying the device construction to customize the device to accommodate individual structural needs and meet specific patient therapeutic needs and requirements. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05).
As to claim 6, the modified Hyde et al. discloses the first electrode is made of a flexible conductive polymer ([0079]).
As to claim 7, the modified Hyde et al. discloses the second electrode is made of a flexible conductive polymer ([0079]).
As to claim 8, the modified Hyde et al. discloses the body part comprises a forming surface from which the first electrode fixing part and the second electrode fixing part protrude, and the second electrode fixing part is disposed at an angle of 80° to 90° with respect to a reference plane of the forming surface (Figure 5).
As to claim 9, the modified Hyde et al. discloses the body part is configured as a pair of body parts (arc(s), depicted as 504a and 504b in Figure 5) respectively corresponding to the left and right ears, wherein the pair of body parts are configured such that the respective second electrode fixing parts and the respective first electrode fixing parts protrude in a mirror-symmetrical shape with respect to the wearer's head (Figure 5; [0073-0075]).
As to claim 10, the modified Hyde et al. discloses a connection part (connecting loop, depicted as 506 in Figure 5) connecting the pair of body parts to each other, wherein the connection part applies a force in a direction in which the body parts make close contact with the wearer's head (Figure 5; [0073-0075]).
As to claim 11, the modified Hyde et al. discloses each of the body parts comprises a forming surface from which the first electrode fixing part and the second electrode fixing part protrude, and the second electrode fixing part is disposed at an angle of 80° to 90° with respect to a reference plane of the forming surface (Figure 5).
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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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796