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 Amendment
The amendment filed May 4, 2026 has been entered. Claims 77-78, 80, 83-84 have been amended. Claims 1-76, 86-95 are canceled. Claims 96-97 are new. Currently, claims 77-85 and 96-97 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 8-11, filed May 4, 2026, with respect to the rejection(s) of claim(s) 77-85 and 96-97 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Miller (US 2015/0202428) and alternatively, Minogue et al. (US 2010/0152810).
Claim Rejections - 35 USC § 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.
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.
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.
Claim(s) 77-78, 81-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGiorgio et al. (US 2014/0188200) in view of Miller (US 2015/0202428).
Regarding claims 77 and 83, DeGiorgio et al. discloses an electrode system for stimulation of the anterior portion of the head of a user (fig. 2), the system comprising a first anterior electrode 12b and a second anterior electrode 14b, each of said first and second anterior electrodes having a first end, a second end, a height and a length, and a contour (fig. 3b), wherein: said heights of said first and said second anterior electrodes, at a maximal point thereof, being in the range of 10mm to 40mm (“12.5mm” [0054], fig. 3b), said first and second anterior electrodes are configured to be arranged, when disposed on the user’s head, horizontally alongside one another (fig. 3b), such that said second end of said first anterior electrode is adjacent said first end of said second anterior electrode with a distance therebetween.
DeGiorgio et al. does not expressly disclose said distance being in the range of 1mm to 15mm and a length consisting of said length of said first electrode, said length of said second electrode, and said distance, is in the range of 20mm to 55mm, and instead recites an inter-electrode distance of 17.5mm and a length of 82.5mm (32.5+17.5+32.5=82.5) ([0054], fig. 3b). However, DeGiorgio et al. also acknowledges that the inter-electrode distance may be less than 17.5mm and the length of the first and the second electrode may be less than 32.5mm ([0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeGiorgio et al. to select an distance between the first electrode and the second electrode in the range of 1mm to 15mm and an electrode length of the first electrode and the second electrode such that a length consisting of said length of said first electrode, said length of second electrode and said distance is in the range of 20mm to 50mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of DeGiorgio et al. would not operate differently with the claimed length of said first electrode, second electrode and distance therebetween the first and second electrodes, the modification being variable to accommodate children and adults, and for males and females (“The electrode size and the inter-electrode distance may vary for children and adults, and for males and females.” [0054]).
DeGiorgio et al. does not expressly disclose wherein one of the following is true: said contour of said first anterior electrode is different from said contour of said second anterior electrode; or said contour of said first anterior electrode is identical to said contour of said second anterior electrode, and said first and second anterior electrodes are configured such that when said first anterior electrode and said second anterior electrode are disposed on the user’s head, said second anterior electrode is rotationally offset relative to said first anterior electrode. Miller teaches an analogous system comprising a first anterior electrode and a second anterior electrode (fig. 2b) on an electrode assembly 200 (fig. 2a) configured for stimulation of the anterior portion of the head of a user (fig. 1), each of said first and second anterior electrodes 320 having a contour, said contour of said first anterior electrode is identical to said contour of said second anterior electrode, and said first and second anterior electrodes are configured such that when said first anterior electrode and said second anterior electrode are disposed on the user’s head, said second anterior electrode is rotationally offset relative to said first anterior electrode (fig. 3a). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeGiorgio et al. such that the contour of said first anterior electrode is identical to said contour of said second anterior electrode, and said first and second anterior electrodes are configured such that when said first anterior electrode and said second anterior electrode are disposed on the user’s head, said second anterior electrode is rotationally offset relative to said first anterior electrode as taught by Miller as it is a known configuration for anterior electrodes and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 78, DeGiorgio et al. discloses wherein said first anterior electrode is configured, when disposed on the user’s head, to be disposed above the supratrochlear nerve on one side of the user’s head, and said second anterior electrode is configured, when disposed on the user’s head, to be disposed above the supraorbital nerve on said one side of the user’s head (“external electrodes are positioned over the foramina of the supraorbital or ophthalmic nerves… electrodes may be positioned at a region of the patient's face (on the right and/or left side) corresponding with the supratrochlear nerve” [0044]).
Regarding claim 81, DeGiorgio et al. discloses wherein the ratio between an area of said first anterior electrode and an area of said second anterior electrode is in the range of 0.5-2 (electrodes 12b and 14b are disclosed to comprise the same length and height ([0054]) and therefore regarded as having an area ratio of 1).
Regarding claim 82, DeGiorgio et al. discloses wherein said area of said first anterior electrode is equal to said area of said second anterior electrode ([0054], also see claim 81).
Claim(s) 79-80, 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGiorgio et al. (US 2014/0188200) in view of Miller (US 2015/0202428) and further in view of Caldwell et al. (US 2004/0073129).
Regarding claim 79, DeGiorgio et al. does not expressly disclose each of said first and second anterior electrodes comprising a liquid-absorbent layer having a biocompatible contact surface, said contact surface adapted to be juxtaposed against the skin surface; and an electrode backing, attached to said liquid-absorbent layer, said backing containing at least one electrically conductive material or element, said conductive material or element being electrically connected with said liquid absorbent layer, when said liquid-absorbent layer is filled with liquid. Caldwell et al. teaches it is known in the art for electrodes configured for being juxtaposed against the skin surface to comprise a liquid-absorbent layer 320 having a biocompatible contact surface 310; and an electrode backing 340 attached to said liquid-absorbent layer, said backing containing at least one electrically conductive material or element 330, said conductive material or element being electrically connected with said liquid-absorbent layer 320, when said liquid-absorbent layer is filled with liquid ([0040-0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeGiorgio et al. to use the pliable electrode structure as taught by Caldwell et al. as it is a known electrode to improve similar externally head mounted devices, the pliability and compressibility features of such an electrode structure capable of helping the electrode better conform to the shape of the user’s head ([0041]).
Regarding claim 80, DeGiorgio et al. discloses wherein said first and second anterior electrodes are disposed on a joint non-conductive substrate (“insulative connection region 16 connects the first and second contact pairs to each other” [0046]), said joint substrate comprising a first contact portion 18 in electrical contact with said electrode backing of said first anterior electrode and a second contact portion 18 in electrical contact with said electrical backing of said second anterior electrode ([0046]; fig. 3a).
Regarding claim 97, DeGiorgio et al. discloses further comprising an electrode receiving unit 24 (“elastic band or strap… hat, band, or a cap” DeGiorgio [0047]; Caldwell fig. 2b) configured to receive therein the joint substrate on which are disposed the first anterior electrode and the second anterior electrode (fig. 2, 3a).
Claim(s) 84-85 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGiorgio et al. (US 2014/0188200) in view of Miller (US 2015/0202428) and further in view of Afanasewicz et al. (US 2012/0253163).
Regarding claim 84, DeGiorgio et al. does not expressly disclose wherein said first and second anterior electrodes define a perimeter which extend, at a lower end thereof, along a single concave contour defined between first and second boundary points disposed at opposite ends of the concavity and adapted to generally follow the outline of the user’s eyebrows, wherein: A/L ≥ 0.5mm; A being an area bounded by: (i) a line between said first and second boundary points, and (ii) said concavity; L being a length of said line between said boundary points; said length (L) being at least 10mm; wherein a line disposed between a first point on said concave contour and a second point on said perimeter, on a side opposite said concave contour, and aligned in perpendicular fashion with respect to said contour at said first point, has a length H, wherein, over an entirety of said concave contour, Hmax/Hmin≤2.5, , Hmax being a maximum value of H over said entirety; and Hmin being a minimum value of H over said entirety. Afanasewicz et al. teaches electrodes comprising a concave contour portion 78 ([0030]) to facilitate proper placement of the electrode to trace up and around the lateral and top edges of the patient’s eyebrow to reinforce corrective placement of the electrode ([0031]; [0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of DeGiorgio et al. to provide a single concave contour defined between boundary points and adapted to generally follow the outline of the user’s eyebrows as taught by Afanasewicz et al. in order to “reinforce corrective placement of the electrodes” ([0035]); the specific shape of the contour to follow the claimed structure would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the electrodes of DeGiorgio et al. to the claimed dimensions since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of DeGiorgio et al. would not operate differently with the claimed dimensions.
Regarding claim 85, DeGiorgio et al. does not expressly disclose wherein an angle between said line and said second end of said first anterior electrode adjacent said distance is in the range of 40-110 degrees. However, the specific shape of the contour to follow the claimed structure would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the electrodes of DeGiorgio et al. to the claimed dimensions since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of DeGiorgio et al. would not operate differently with the claimed dimensions.
Claim(s) 77-78, 81-82 and 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGiorgio et al. (US 2014/0188200) in view of Minogue et al. (US 2010/0152810).
Regarding claims 77 and 96, DeGiorgio et al. discloses an electrode system for stimulation of the anterior portion of the head of a user (fig. 2), the system comprising a first anterior electrode 12b and a second anterior electrode 14b, each of said first and second anterior electrodes having a first end, a second end, a height and a length, and a contour (fig. 3b), wherein: said heights of said first and said second anterior electrodes, at a maximal point thereof, being in the range of 10mm to 40mm (“12.5mm” [0054], fig. 3b), said first and second anterior electrodes are configured to be arranged, when disposed on the user’s head, horizontally alongside one another (fig. 3b), such that said second end of said first anterior electrode is adjacent said first end of said second anterior electrode with a distance therebetween.
DeGiorgio et al. does not expressly disclose said distance being in the range of 1mm to 15mm and a length consisting of said length of said first electrode, said length of said second electrode, and said distance, is in the range of 20mm to 55mm, and instead recites an inter-electrode distance of 17.5mm and a length of 82.5mm (32.5+17.5+32.5=82.5) ([0054], fig. 3b). However, DeGiorgio et al. also acknowledges that the inter-electrode distance may be less than 17.5mm and the length of the first and the second electrode may be less than 32.5mm ([0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeGiorgio et al. to select an distance between the first electrode and the second electrode in the range of 1mm to 15mm and an electrode length of the first electrode and the second electrode such that a length consisting of said length of said first electrode, said length of second electrode and said distance is in the range of 20mm to 50mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of DeGiorgio et al. would not operate differently with the claimed length of said first electrode, second electrode and distance therebetween the first and second electrodes, the modification being variable to accommodate children and adults, and for males and females (“The electrode size and the inter-electrode distance may vary for children and adults, and for males and females.” [0054]).
DeGiorgio et al. does not expressly disclose wherein one of the following is true: said contour of said first anterior electrode is different from said contour of said second anterior electrode; or said contour of said first anterior electrode is identical to said contour of said second anterior electrode, and said first and second anterior electrodes are configured such that when said first anterior electrode and said second anterior electrode are disposed on the user’s head, said second anterior electrode is rotationally offset relative to said first anterior electrode. Minogue et al. teaches an analogous system comprising a first anterior electrode 16a and a second anterior electrode 16b on an electrode assembly 20 (fig. 4) configured for stimulation of the head of a user, each of said first and second anterior electrodes 16a-b having a contour, said contour of said first anterior electrode is different from said contour of said second anterior electrode (fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeGiorgio et al. such that the contour of said first anterior electrode is different from said contour of said second anterior electrode as taught by Minogue et al. as it is a known configuration for stimulation electrode electrodes, would be beneficial in targeting specific facial nerves ([0048]) and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim(s) 79-80, 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGiorgio et al. (US 2014/0188200) in view of Minogue et al. (US 2010/0152810) and further in view of Caldwell et al. (US 2004/0073129).
Regarding claim 79, DeGiorgio et al. does not expressly disclose each of said first and second anterior electrodes comprising a liquid-absorbent layer having a biocompatible contact surface, said contact surface adapted to be juxtaposed against the skin surface; and an electrode backing, attached to said liquid-absorbent layer, said backing containing at least one electrically conductive material or element, said conductive material or element being electrically connected with said liquid absorbent layer, when said liquid-absorbent layer is filled with liquid. Caldwell et al. teaches it is known in the art for electrodes configured for being juxtaposed against the skin surface to comprise a liquid-absorbent layer 320 having a biocompatible contact surface 310; and an electrode backing 340 attached to said liquid-absorbent layer, said backing containing at least one electrically conductive material or element 330, said conductive material or element being electrically connected with said liquid-absorbent layer 320, when said liquid-absorbent layer is filled with liquid ([0040-0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify DeGiorgio et al. to use the pliable electrode structure as taught by Caldwell et al. as it is a known electrode to improve similar externally head mounted devices, the pliability and compressibility features of such an electrode structure capable of helping the electrode better conform to the shape of the user’s head ([0041]).
Regarding claim 80, DeGiorgio et al. discloses wherein said first and second anterior electrodes are disposed on a joint non-conductive substrate (“insulative connection region 16 connects the first and second contact pairs to each other” [0046]), said joint substrate comprising a first contact portion 18 in electrical contact with said electrode backing of said first anterior electrode and a second contact portion 18 in electrical contact with said electrical backing of said second anterior electrode ([0046]; fig. 3a).
Regarding claim 97, DeGiorgio et al. discloses further comprising an electrode receiving unit 24 (“elastic band or strap… hat, band, or a cap” DeGiorgio [0047]; Caldwell fig. 2b) configured to receive therein the joint substrate on which are disposed the first anterior electrode and the second anterior electrode (fig. 2, 3a).
Claim(s) 84-85 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGiorgio et al. (US 2014/0188200) in view of Minogue et al. (US 2010/0152810) and further in view of Afanasewicz et al. (US 2012/0253163).
Regarding claim 84, DeGiorgio et al. does not expressly disclose wherein said first and second anterior electrodes define a perimeter which extend, at a lower end thereof, along a single concave contour defined between first and second boundary points disposed at opposite ends of the concavity and adapted to generally follow the outline of the user’s eyebrows, wherein: A/L ≥ 0.5mm; A being an area bounded by: (i) a line between said first and second boundary points, and (ii) said concavity; L being a length of said line between said boundary points; said length (L) being at least 10mm; wherein a line disposed between a first point on said concave contour and a second point on said perimeter, on a side opposite said concave contour, and aligned in perpendicular fashion with respect to said contour at said first point, has a length H, wherein, over an entirety of said concave contour, Hmax/Hmin≤2.5, , Hmax being a maximum value of H over said entirety; and Hmin being a minimum value of H over said entirety. Afanasewicz et al. teaches electrodes comprising a concave contour portion 78 ([0030]) to facilitate proper placement of the electrode to trace up and around the lateral and top edges of the patient’s eyebrow to reinforce corrective placement of the electrode ([0031]; [0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of DeGiorgio et al. to provide a single concave contour defined between boundary points and adapted to generally follow the outline of the user’s eyebrows as taught by Afanasewicz et al. in order to “reinforce corrective placement of the electrodes” ([0035]); the specific shape of the contour to follow the claimed structure would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the electrodes of DeGiorgio et al. to the claimed dimensions since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of DeGiorgio et al. would not operate differently with the claimed dimensions.
Regarding claim 85, DeGiorgio et al. does not expressly disclose wherein an angle between said line and said second end of said first anterior electrode adjacent said distance is in the range of 40-110 degrees. However, the specific shape of the contour to follow the claimed structure would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the electrodes of DeGiorgio et al. to the claimed dimensions since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of DeGiorgio et al. would not operate differently with the claimed dimensions.
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/ERICA S LEE/Primary Examiner, Art Unit 3796
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