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 filed on 11/30/2025 have been fully considered but they are not persuasive. Applicant argues that Examiner’s previous objection to the application data sheet filed on 05/22/2025 is incorrect. Examiner respectfully maintains this objection and reiterates that the correctly spelled word was struck through while the incorrectly spelled word was not (See annotated ADS below). The examiner notes the ending of the word as currently written is “grafic” and should be “graphic”
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Annotated ADS filed on 05/22/2025
Regarding newly amended claim 1, Applicant argues that the amendment establishes a specific design principle not taught by the cited prior art and clarifies the technical relationship between the discontinuity zones and the functional requirements of the electrode support device. Examiner respectfully disagrees as no actual dimensions are required by the claim, therefore the amendment does not clarify a technical relationship between the discontinuity zones and the functional requirements. It appears that the limitation, “wherein said totality of said areas of said discontinuity zones is dimensioned to provide a compromise between rigidity sufficient to ensure contact of said electrodes and elasticity from mechanical stretchiness obtained from said discontinuity zones” is merely intended use since no actual dimensions are recited in the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In order to further advance prosecution, Examiner notes that Collura discloses the electrode holder being configured for engagement with a fixture supported by a strap for holding the electrode assembly in contact with a scalp (Col. 1, ln 59-62) and adjustment straps that optimize the fit (Col. 4, ln 57-58). Collura further discloses adjustment of the electrode wrap holders within the mounts further compresses the flexible, absorptive electrode wrap, causing flow of the conductive solution therein and enhancement of the electrical contact (Abstract). Therefore, Collura teaches the newly added limitation.
Applicant further argues that Badower’s flexibility comes from the inherent properties of the material itself, not from strategically dimensioned holes and cuts that create discontinuity. Examiner respectfully disagrees as Badower was not relied upon to teach the discontinuity zones, only a cap made from a flexible polymeric material (Badower, [0084]). As discussed above, Collura satisfies the newly added limitation of wherein said totality of said areas of said discontinuity zones is dimensioned to provide a compromise between rigidity sufficient to ensure contact of said electrodes and elasticity from mechanical stretchiness obtained from said discontinuity zones.
Regarding claim 5, Applicant further argues that while Collura’s Figure 9 shows openings that appear evenly distributed, Collura does not teach homogenously distributed discontinuity zones that are dimensioned to provide the claimed compromise between rigidity and elasticity. As discussed above, with respect to claim 1, no dimensions are recited in the claim, therefore any evenly distributed discontinuity zones would meet the limitations recited in claim 5. Collura does teach homogenously distributed discontinuity zones (Fig. 8 shows openings 30 evenly distributed on straps 32).
Regarding newly amended claim 8, Applicant argues that prior art fails to disclose “said conductive element being provided as a separate conductive track consisting of a single layer of conductive ink deposited directly on said flexible support element” since Ayer teaches a sandwich design. Examiner notes that Ayer discloses said conductive element (conductive ink) being provided as a separate conductive track consisting of a single layer of conductive ink (conductive ink layer 48) deposited directly on said flexible support element (branch leads 31-36; Figures 1 and 4). Examiner notes that support sheets 44 and 46 along with exterior shielding layers form the branch leads 31-36 (Figure 4). Therefore, the conductive ink layer 48 is deposited directly onto support sheets 44 and 46 which form the branch lead. Examiner further notes that exterior layers 64 and 66 are also formed by conductive ink and printed directly on the outer surfaces of the support sheets 44 and 46 (Col. 5, ln 19-24). Therefore, Ayer discloses said conductive element (ink) being provided as a separate conductive track consisting of a single layer of conductive ink (deposited directly on said flexible support element (Col. 5, ln 19-24: exterior layers have conductive ink printed directly on them; Figure 4).
Applicant further argues that Examiner’s misinterpretation of the contact portion with Ayers connector contacts is factually incorrect and invalidates the entire rejection of claim 8. Examiner respectfully disagrees and notes that “a contact portion” is a very broad term and since the claim does not require that the contact portion be in contact with anything other than the branch, the contacts (Figure 1: contacts 72) as taught by Ayer would satisfy the current claim language under broadest reasonable interpretation. Lastly, Applicant argues that one of ordinary skill in the art would not be motivated to integrate Ayer’s removable electrode assembly into Collura’s cap by directly depositing ink on the cap’s surface. Examiner respectfully disagrees as Collura was never modified to have the conductive ink as taught by Ayer to be printed on the inside of the cap. Examiner maintains it would have been obvious to modify the cap as disclosed by Collura to hold the electrodes as taught by Ayer. Such a modification would produce the predictable results of maintaining the proper positioning of an ECG cable set with flexible and conductive ink layers.
Specification
The disclosure is objected to because of the following informalities: Applicant’s newly filed ADS incorrectly lists the title of the invention as “…The correctly spelled word is struck through and the misspelled word is not struck through. Examiner suggests amending the ADS to strike through the misspelled word and underline the new spelling as is required. See MPEP 601.05(a)(II) for guidance on correcting and updating an ADS. Appropriate correction is required.
Claim Objections
Claim 8 is objected to because of the following informalities: It appears as the last limitation is almost repeated twice except for the small distinction of the word “directly”. Examiner suggests amending the claim to recite, “[[said conductive element being provided as a separate conductive track made of a layer of conductive ink deposited on the flexible support element,]] said conductive element being provided as a separate conductive track consisting of a single layer of conductive ink deposited directly on said flexible support element” in order to increase clarity. Appropriate correction is respectfully requested.
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 1-3, 5-6, and 10 are 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.
Regarding claim 1, the limitation, “wherein said totality of said areas of said discontinuity zones is dimensioned to provide a compromise between rigidity sufficient to ensure contact of said electrodes and elasticity from mechanical stretchiness obtained from said discontinuity zones” renders the claim unclear. It is unclear to Examiner what dimensioning wouldn’t provide a compromise between rigidity and elasticity. In order to further advance prosecution Examiner is interpreting the dimensions of said totality of said areas of said discontinuity zones to be any dimension since no specific ranges or values are recited in the claim. Dependent claims inherit the same deficiencies.
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.
Claim(s) 1, 3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Collura et al (US 6574513) hereinafter Collura, in view of Badower et al (US 2016/0007918) hereinafter Badower.
Regarding claim 1, Collura discloses an electrode support device for recording electroencephalographic signals (Fig. 8), comprising:
a cap (Figure 8: straps 32) configured to at least partially surround the skull of a patient, so that said cap has an inner surface in contact with the patient's scalp (Col. 4, ln 20-22: straps or other configured headgear is put on),
wherein said cap is further configured to place, in pre-defined zones (openings 30), a plurality of electrodes in contact with the patient's scalp (Col. 4, ln 13-16: Each opening can be provided with a permanently mounted retainer ring 24, whereby electrodes can be installed),
wherein said cap has first holes defined therein (openings 30), said first holes being configured to receive said plurality of electrodes (Col. 4, ln 13-16), and further has second holes and/or cuts defined therein (gaps created by the positioning of straps 32), so as to create discontinuity zones within said cap, said second holes and/or cuts being dimensioned differently than said first holes (Examiner notes the gaps created by the straps 32 are a different shape from the circular openings 30 in the straps 32), and forming discontinuity zones within said cap so as to increase a stretching of said cap (gaps created by the positioning of straps 32 would create discontinuity zones),
wherein said totality of said areas of said discontinuity zones is dimensioned to provide a compromise between rigidity sufficient to ensure contact of said electrodes and elasticity from mechanical stretchiness obtained from said discontinuity zones (See annotated Fig. 8).
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Annotated Fig. 8
Collura fails to disclose wherein said cap is made from a flexible polymeric material, however Badower discloses a cap made from a flexible polymeric material ([0084] The example strips 106-114 and the central support member 116 of the illustrated example are constructed of a flexible material such as, for example, polyurethane). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Collura with a cap being made from a flexible polymeric material as taught by Badower since such a modification would provide the predictable results of allowing the cap to sit comfortably and closely to the scalp of the user to allow the electrodes to engage the surface of the scalp, resulting in better contact and signal collection [0084].
Regarding claim 3, the modified Collura discloses the system of claim 1 as discussed above, but fails to disclose wherein said flexible polymeric material consists of polyurethane. However, Badower discloses wherein said flexible polymeric material consists of polyurethane ([0084] The example strips 106-114 and the central support member 116 of the illustrated example are constructed of a flexible material such as, for example, polyurethane). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Collura with said flexible polymeric material consisting of polyurethane as taught by Badower since such a modification would provide the predictable results of allowing the cap to sit comfortably and closely to the scalp of the user to allow the electrodes to engage the surface of the scalp, resulting in better contact and signal collection [0084].
Regarding claim 5, Collura discloses wherein said discontinuity zones (openings 30 and gaps created by straps 32) are homogenously distributed on a surface of said cap (Figure 8 shows openings 30 being evenly distributed on strap 32 which also creates evenly distributed gaps; see annotated Fig. 8 above).
Regarding claim 6, Collura discloses discontinuity zones ( Fig. 8 shows openings 30 being evenly distributed on strap 32 which also creates evenly distributed gaps; see annotated Fig. 8 above) but does not disclose expressly wherein said discontinuity zones extend between 5% and 25% of a total surface of said cap. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the discontinuity zones as taught by Collura with said discontinuity zones extending between 5% and 25% of a total surface of said cap, 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Collura (US 6574513) in view of Badower (US 2016/0007918) and Goldstein et al (US 2018/0235541) hereinafter Goldstein and further in view of Attal et al (US 2016/0157777) hereinafter Attal.
Regarding claim 2, the modified Collura discloses the system of claim 1 as discussed above, but fails to disclose wherein said flexible polymeric material consists of a transparent material, wherein said second holes and/or cuts have triangular or polygonal shapes.
Goldstein discloses an EEG cap consisting of a transparent material ([0074] The EEG apparatus 100 may be transparent or clear). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the flexible polymeric material as taught by Collura to consist of a transparent material as taught by Goldstein, since such a modification would provide the predictable results of allowing electrodes to be seen, which may facilitate proper positioning [0074].
Attal discloses holes and/or cuts having triangular or polygonal shapes ([0095] a cylindrical, triangular or rectangular shape with a rounded free end forming the skin contact interface). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Collura with holes and/or cuts having triangular or polygonal shapes as taught by Attal. Such a modification would provide the predictable results of providing sufficient and painless contact with the subject skin through the hair (Attal, [0095]).
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Collura (US 6574513) in view of Badower (US 2016/0007918) and further in view of Ayer (US 4353372), as evidenced by Mistretta (US 2020/0069934) hereinafter Mistretta (2020).
Regarding claim 8, Collura discloses an electrode support device for recording electroencephalographic signals (Figure 9), comprising:
a cap (cap 34) configured to at least partially surround the skull of a patient, so that said cap has an inner surface in contact with the patient's scalp (Col. 4, ln 20-22: cap is put on); and
a plurality of electrodes in contact with the patient's scalp, the plurality of electrodes being disposed on an inner surface of said cap in predetermined zones (Col. 4, ln 13-16: Each opening can be provided with a permanently mounted retainer ring 24, whereby electrodes can be installed),
wherein said cap has holes and/or cuts defined therein (Figure 9: openings 30), so as to create discontinuity zones within said cap and to increase a stretching of said cap (Col. 4, ln 12-14),
wherein an entirety of areas of said discontinuity zones extends for a minority of an area covered by said cap (Fig. 9: openings 30; Examiner notes that the openings shown in Fig. 9 extend for a minority of an area covered by cap 34).
Collura fails to disclose wherein said cap is made from a flexible polymeric material, wherein said plurality of electrodes is arranged as an electrode assembly having of a plurality of branches extending from a main conductive track, each branch having a contact portion and a transmission portion, each branch further having a flexible support element of a conductive element, said flexible support element having a head terminal and a tail terminal, and
wherein said conductive element has at least one head contact and at least one tail contact, respectively arranged at the head terminal and the tail terminal of the flexible support element, said conductive element being provided as a separate conductive track made of a layer of conductive ink deposited on the flexible support element, said conductive element being provided as a separate conductive track consisting of a single layer of conductive ink deposited directly on said flexible support element.
Badower discloses a cap made from a flexible polymeric material ([0084] The example strips 106-114 and the central support member 116 of the illustrated example are constructed of a flexible material such as, for example, polyurethane). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Collura with a cap being made from a flexible polymeric material as taught by Badower since such a modification would provide the predictable results of allowing the cap to sit comfortably and closely to the scalp of the user to allow the electrodes to engage the surface of the scalp, resulting in better contact and signal collection [0084].
Ayer discloses wherein said plurality of electrodes is arranged as an electrode assembly (CG cable set 20) having of a plurality of branches (leads 31-36) extending from a main conductive track (common trunk 40),
each branch having a contact portion (attachment pad 21) and a transmission portion (conductive pad 49; Col. 4, ln 57-62),
each branch further having a flexible support element (Col. 3, ln 50: flexible outer layers 44 and 46) of a conductive element (Col. 5, ln 17: conductive ink layer 48),
said flexible support element having a head terminal (Fig. 2: outer layers 44 and 46 of attachment pad 26) and a tail terminal (connector 42; Col. 5, ln 11-13: The flat, flexible sandwich design is carried through to branch leads 31-36, common trunk 40, and connector 42) and
wherein said conductive element has at least one head contact (connection of conductive ink layer 48 with conductive pad 49; Col. 3, ln 53-54: Leading away from conductive pad 49 is a thin line of material 48) and
at least one tail contact (Col. 6, ln 18-25: interior conductor 48 extends to establish electrical communication with a respective one of contacts 72), respectively arranged at the head terminal and the tail terminal of the flexible support element (See annotated Fig. 1),
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Annotated Figure 1
said conductive element being provided as a separate conductive track (ink layer 48) made of a layer of conductive ink deposited on the flexible support element (Col. 3, ln 61-63: conductive inner layer 48, 49 is printed on Mylar sheet 46 with conductive ink),
said conductive element being provided as a separate conductive track (ink layer 48) consisting of a single layer of conductive ink deposited directly on said flexible support element (Col. 3, ln 61-63: conductive inner layer 48, 49 is printed on Mylar sheet 46 with conductive ink).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Collura with wherein said plurality of electrodes is arranged as an electrode assembly having of a plurality of branches extending from a main conductive track, each branch having a contact portion and a transmission portion, each branch further having a flexible support element of a conductive element, said flexible support element having a head terminal and a tail terminal, and wherein said conductive element has at least one head contact and at least one tail contact, respectively arranged at the head terminal and the tail terminal of the flexible support element, said conductive element being provided as a separate conductive track made of a layer of conductive ink deposited on the flexible support element, said conductive element being provided as a separate conductive track consisting of a single layer of conductive ink deposited directly on said flexible support element as taught by Ayer. Such a modification would provide the predictable results of further increasing the cost-effectiveness related to the production of the patient contact portion, thanks to the low cost of ink with a high magnetic charge such as a nickel ink [0054] as evidenced by Mistretta (2020).
Regarding claim 9, the modified Collura discloses the system of claim 8 as discussed above, but fails to disclose a means for fixing said contact portion of said branches to edges of said through holes of the cap. However, Ayer discloses a means for fixing said contact portion of said branches to edges of said through holes of the cap (Figure 3; Col. 5, ln 4-5: Surface 62A of ring 62 and 52C of 52 is secured adhesively to the skin of the patient; Examiner notes that this adhesive would be capable of fixing the contact portion to the edges of the through holes). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Collura with a means for fixing said contact portion of said branches to edges of said through holes of the cap as taught by Ayer since such a modification would provide the predictable results of allowing the electrodes to be accurately placed and maneuvered as needed.
Regarding claim 10, Collura discloses an inner surface or an outer surface of the cap (Fig. 9: cap 34), but fails to disclose wherein said inner surface or outer surface of the cap has a plurality of conductive tracks made of at least one conductive ink layer. However, Ayer discloses a plurality of conductive tracks made of at least one conductive ink layer (Fig. 1: inner layers 48; Col. 5, lines 16-18, conductive ink layer 48). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Collura with a plurality of conductive tracks made of at least one conductive ink as taught by Ayer, since such a modification would provide the predictable results of further increasing the cost-effectiveness related to the production of the patient contact portion, thanks to the low cost of ink with a high magnetic charge such as a nickel ink [0054] as evidenced by Mistretta (2020).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hao et al (US 2022/0151555) discloses an EEG cap having polygonal holes [0053].
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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792