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 preliminary amendment filed December 16, 2025 has been entered. Claims 1-76 and 86-95 have been canceled. Currently, claims 77-85 are pending for examination.
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 77-85) in the reply filed on December 16, 2025 is acknowledged.
Applicant has canceled claims 86-93 and 94, directed to Inventions II and III, respectively.
Specification
The disclosure is objected to because of the following informalities: The “Related Applications” section of the specification should be updated to reflect the current status of the US Patent Applications that have US Patent Numbers.
Appropriate correction is required.
Claim Objections
Claim 77 is objected to because of the following informalities: line 1 recites, “An electrode system for stimulation of the anterior portion of the head of the user”. While the claim indicates intended use for a human organism (“the anterior portion of the head of a user”), it is suggested to amend the claim to use the phrase, “configured for” to maintain consistency with line 6 (“said first and second anterior electrodes are configured to be arranged”). Appropriate correction is required.
Claim 80 is objected to because of the following informalities: line 2 introduces, “a joint substrate” but then immediately references, “said shared substrate”. It is suggested to amend the claim to recite, “said joint substrate”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 78 and 84 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 78 recites the limitation "said headset" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 84 recites the limitation, “said boundary points of said concavity; and said concavity” in lines 7-8 which is grammatically confusing.
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).
Regarding claim 77, 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 (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]).
Regarding claim 78, DeGiorgio et al. discloses wherein said first anterior electrode is configured, when said headset (see 112 rejection above) is donned, to be disposed above the supratrochlear nerve on one side of the user’s head, and said second anterior electrode is configured, when the headset is donned, 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).
Regarding claim 83, DeGiorgio et al. discloses wherein a contour of said first anterior electrode is identical to a contour of said second anterior electrode ([0054]; fig. 3b).
Claim(s) 79-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeGiorgio et al. (US 2014/0188200) 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. in view of Caldwell et al. discloses wherein said first and second anterior electrodes are disposed on a joint substrate 24 (“elastic band or strap… hat, band, or a cap” DeGiorgio [0047]; Caldwell fig. 2b), said shared substrate comprising a first contact portion 240 in electrical contact with said electrode backing of said first anterior electrode and a second contact portion 240 in electrical contact with said electrical backing of said second anterior electrode (fig. 2b).
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 Afanasewicz et al. (US 2012/0253163).
Regarding claim 84, DeGiorgio et al. does not expressly disclose said first and second anterior electrodes extending, 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 a line between said boundary points of said concavity, and 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 maximun 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Miller (US 2015/0202428) and Minogue et al. (US 2010/0152810).
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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/ERICA S LEE/Primary Examiner, Art Unit 3796