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 .
The current application has the effective filing date of 12/20/2021 according to the priority chain on the record.
Claim Status
As per Applicant’s response received on 06/08/2026, claims 1-7, 9-10, 17-19 and 30 are pending; claims 8, 11-16, 20-29 and 31-35 have been cancelled, and claims 1, 9, 17, and 30 have been amended.
Response to Amendment
The 35 USC 112(b) rejection to claims 8-16 are withdrawn in view of cancellation of claims and current claim amendments.
As for the 35 USC 102 rejections based on either Goodall et al. US 2019/0046794 or Cartledge et al. US 2017/0087364, the Applicant’s arguments have been fully considered, but are moot in view of new grounds of rejections made below.
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 2-3 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.
Claims 2 and 3 both recite the limitation "said at least second electrode." There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 7, the claim recites “wherein said at least one electrode is customizable to fit ear cavum concha area”, this limitation fails to further limit the base claim as it repeats limitations already present in claim 1.
Claim 19 is also rejected as failing to further limit claim 17 for the same rationale as discussed to claim 7 above.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 7, 9-10, 17, 19 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. US 2017/0087364 A1 (hereinafter “Cartledge”, previously cited) in view of Dietrich et al. US 2008/0249597 A1 (hereinafter “Dietrich”).
Regarding claim 1, Cartledge discloses a device for auricular vagal nerve stimulation (Abstract: electrostimulation device; see Figs. 4-21) in a subject, said device having an electrode configuration comprising:
at least one electrode contact (anode/positive electrode; see [300] and [0464: last sentence]) operative to be adhered to a first portion of inner skin surface of an ear Cavum Concha of the subject (Fig.4, electrode 8 are placed in cavum concha, also see [0253-0256]); and,
wherein the at least one electrode contact comprises a plurality of peripheral indentations (see Figs. 86-87: 8136, 8138 are shade areas indicating electrodes- which are protrusions away from the surface of the ear worn device, this would make the non-shaded area, i.e. 8130, indentations on the on the surface of the ear worn device; see [0302: last 2 sentences]. The Examiner interprets Fig. 86-87: 8130 to encompass “a plurality of peripheral indentations” in this claim); and
at least one return electrode with an opposite polarity (cathode/negative electrode; [0464: last sentence]) operative to be adhered to a skin surface of the subject to a rear region of the ear of the subject (see Figs. 4- 5, electrode 8’ placed on back of ear; see [0253-0256]).
Cartledge disclose wherein the at least one electrode contact is customized to fit the cavum concha area (such as shown in Fig. 4), but does not disclose wherein the at least one electrode contact having a surface area greater than 50% of the skin surface area of the cavum concha. However, Cartledge discloses that the size and particular shape of the electrode can be adapted to fit a particular person’s anatomy ([0432] “It is noted that users have different ear canal shapes and sizes. Accordingly, the following formulas were derived to dictate a curvature of the outer surface of the earbud form for various sizes of the patient coupler.”); thus, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Cartledge’s electrode contact (e.g. Figs. 86: 8100) such that it has a contact surface greater than 50% of the skin surface area of the cavum concha in order to maintain skin contact with the electrode to thus optimize signal quality/strength.
Alternatively, Dietrich, another prior art reference in the analogous art of transcutaneous measurement and stimulation, teaches an auricular apparatus 17 (such as shown in Fig. 5a) comprising an plurality of electrodes thereon, and wherein the auricular apparatus 17 is customized to fit the cavum concha area (such as shown in Fig. 6), and wherein the at least one electrode contact having a surface area greater than 50% of the skin surface area of the cavum concha ([0028, 0033, 0068] optimize electrode contact, [0050] “FIG. 6 an exemplary embodiment of an application apparatus which covers the entire concha” this is sufficient to meet the claim limitation “wherein the at least one electrode contact having a surface area greater than 50% of the skin surface area of the cavum concha”). As such, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Cartledge such that the electrode contact size is it is the size having a surface area greater than 50% of the skin surface area of the cavum concha in order to optimize electrode contact and for comfort of the user as it fit within the entire concha in view of Dietrich. (Cartledge: [0031] “This structure is customizable in length, angulation, and orientation to optimize contact between the electrodes and the target structure as well as a position for the duration of therapy.” Dietrich: [0062])
Regarding claim 7, Cartledge in view of Dietrich discloses the electrode configuration according to claim 1, wherein said at least one electrode is customizable to fit ear Cavum Concha area. (Cartledge: Fig.4, electrode 8 are placed in cavum concha, also see [0253-0256])
Regarding claim 9, Cartledge in view of Dietrich discloses the electrode configuration according to claim 1, the at least one electrode comprises a first electrode and a second electrode, wherein the first electrode and the second electrode each are flexible. (Cartledge: see [0315: 2nd sentence] electrode made of silicone, and is thus flexible and conformable to ear canal)
Regarding claim 10, Cartledge in view of Dietrich discloses the electrode configuration according to claim 1, wherein the at least one electrode is a Transcutaneous electrical nerve stimulation (TENS) electrode. (Cartledge: see Abstract and also [0024-0025] transcutaneous electrical stimulation)
Regarding claim 17, it is rejected by Cartledge and Dietrich, under the same rationale as discussed to claim 1 above.
Regarding claim 19, Cartledge in view of Dietrich discloses the electrode configuration according to claim 17, wherein said at least one electrode is customizable to fit regions of ear. (Cartledge: Fig.4, electrode 8 are placed in cavum concha, also see [0253-0256]; also see Figs.3-7)
Regarding claim 30, Cartledge discloses a method of positioning an electrode on a skin surface area of an ear (Abstract: electrostimulation device; see Figs. 4-21), the method comprising:
positioning an electrode contact (anode/positive electrode; see [300] and [0464: last sentence]) within the Cavum Concha of the ear (Fig.4, electrode 8 are placed in cavum concha, also see [0253-0256]) and positioning a return electrode (cathode/negative electrode; [0464: last sentence]) on a skin are of a rear region of the ear (see Figs. 4- 5, electrode 8’ placed on back of ear; see [0253-0256]).;
measuring an impedance to determine whether the electrode contact and return electrode are properly positioned ([0033-0034] placement onto anatomical sites to reduce signal impedance; also see [0248] “each of the pair of couplers 8 has one of the reciprocal magnetic elements 7 that attract each other, thus creating and maintaining proper contact (and maintaining proper impedance) between the contact leads of the user couplers and the body surface.”);
connecting said electrode to a stimulator (electro-stimulation generator such as shown in Fig. 8-9: 900, [0257]); and,
delivering an electrical stimulation to the ear (see Abstract and [0008-0010]).
Cartledge does not disclose cleaning a skin surface area. However, cleaning skin surface is a routine practice in both human hygiene and in the medical field, in order to achieve good contact to sensors/electrodes and to obtain quality signal. Since Cartledge disclose various ways to detect and achieve good contact between skin and electrodes as discussed immediately above; the Examiner takes official notice that the step of cleaning skin surface is a routine preparatory step prior to attaching or placing Cartledge’s electro-stimulator electrode and device as discussed in the Abstract.
Cartledge disclose wherein the at least one electrode contact is customized to fit the cavum concha area (such as shown in Fig. 4), but does not teach wherein the electrode contact comprises a surface area greater than 50% of the skin surface area of the Cavum Concha. However, Cartledge discloses that the size and particular shape of the electrode can be adapted to fit a particular person’s anatomy ([0432] “It is noted that users have different ear canal shapes and sizes. Accordingly, the following formulas were derived to dictate a curvature of the outer surface of the earbud form for various sizes of the patient coupler.”); thus, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Cartledge’s electrode contact (e.g. Figs. 86: 8100) such that it has a contact surface greater than 50% of the skin surface area of the cavum concha in order to maintain skin contact with the electrode to thus optimize signal quality/strength. Alternatively, Dietrich, another prior art reference in the analogous art of transcutaneous measurement and stimulation, teaches an auricular apparatus 17 (such as shown in Fig. 5a) comprising an plurality of electrodes thereon, and wherein the auricular apparatus 17 is customized to fit the cavum concha area (such as shown in Fig. 6), and wherein the at least one electrode contact having a surface area greater than 50% of the skin surface area of the cavum concha ([0028, 0033, 0068] optimize electrode contact, [0050] “FIG. 6 an exemplary embodiment of an application apparatus which covers the entire concha” this is sufficient to meet the claim limitation “wherein the at least one electrode contact having a surface area greater than 50% of the skin surface area of the cavum concha”). As such, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Cartledge such that the electrode contact size is it is the size having a surface area greater than 50% of the skin surface area of the cavum concha in order to optimize electrode contact and for comfort of the user as it fit within the entire concha in view of Dietrich. (Cartledge: [0031] “This structure is customizable in length, angulation, and orientation to optimize contact between the electrodes and the target structure as well as a position for the duration of therapy.” Dietrich: [0062])
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge and Dietrich as applied to claims 1/17 above, and further in view of Goodall et al. US 2019/0046794 A1 (hereinafter “Goodall”, previously cited).
Regarding claims 2 and 3, Cartledge discloses the electrode configuration according to claim 1 comprising a return electrode adapted to be place behind the ear (see rejection to claim 1), but does not wherein said at least one return electrode comprises a bow shape to facilitate positioning said at least second electrode within the ear canal, and wherein said at least one return electrode comprises a circular shape to facilitate positioning said at least second electrode within the ear canal.
Goodall, another prior art reference in analogous art, discloses a device for auricular vagal nerve stimulation (wearable neural stimulation device 212) in a subject, said device having an electrode configuration comprising: at least one electrode contact (cathode stimulator/electrode) operative to be adhered to a first portion of inner skin surface of an ear Cavum Concha of the subject ([0135:2nd sentence] “In an embodiment, the cathode of the neural stimulator 212 can be configured to be positioned to contact the concha of the pinna (e.g., the cymba 122 and/or cavum 124 of the concha 120 of FIG. 1) …” Also see [0198:5th sentence] attachment mechanism including adhesives); and, at least one return electrode (anode stimulator/electrode) with an opposite polarity operative to be adhered to a second portion of a skin surface of the subject. ([0135: 2nd sentence] “…and the anode neural stimulator 212 can be configured to be positioned on a corresponding portion of the posterior surface of the pinna (e.g., posterior surface of the pinna 106 of FIG. 1)”). Goodall further discloses wherein said at least one return electrode (anode) comprises a bow shape to facilitate positioning said at least second electrode within the ear canal. (Fig.3A and [0173] illustrates a “bow shape” ear canal insert 306 for positioning electrodes relative to concha; Fig. 6A and 6B both illustrate a “bow shape” ear canal insert for positioning electrodes within the ear canal. Similar “bow shape” embodiments are also illustrated in Fig. 6C: 604). It would have been obvious to a person of ordinary skill in the art at the time of invention to further modify Cartledge’s back of ear electrode to take the bow shape, or circular shape as taught in Goodall, the motivation for doing so is to optimize sensor size and shape for user comfort. (Goodall: [0168] exhibit a shape and fit that attaches the wearable neural stimulation device to the ear of the subject)
Regarding claims 4-6, Cartledge and Dietrich discloses the electrode configuration according to claim 1, but Cartledge does not disclose wherein said at least one electrode comprises a surface area within a range of 0.5-2 square centimeters, or within a range of 0.1-5 square centimeters, or within a range of 0.2-1 square centimeters.
Goodall, another prior art reference in analogous art, discloses a device for auricular vagal nerve stimulation (wearable neural stimulation device 212) in a subject, said device having an electrode configuration comprising: at least one electrode contact (cathode stimulator/electrode) operative to be adhered to a first portion of inner skin surface of an ear Cavum Concha of the subject ([0135:2nd sentence] “In an embodiment, the cathode of the neural stimulator 212 can be configured to be positioned to contact the concha of the pinna (e.g., the cymba 122 and/or cavum 124 of the concha 120 of FIG. 1) …” Also see [0198:5th sentence] attachment mechanism including adhesives); and, at least one return electrode (anode stimulator/electrode) with an opposite polarity operative to be adhered to a second portion of a skin surface of the subject. ([0135: 2nd sentence] “…and the anode neural stimulator 212 can be configured to be positioned on a corresponding portion of the posterior surface of the pinna (e.g., posterior surface of the pinna 106 of FIG. 1)”). Goodall further discloses wherein said at least one electrode comprises a surface area within a range of 0.5-2 square centimeters, wherein said at least one electrode comprises a surface area within a range of 0.1-5 square centimeters (See [0135: last sentence] “the cathode and/or anode exhibits a generally circular shape having a diameter that is about… 9 mm to about 1.5 cm”, this is equivalent to surface area of 0.63-1.76 square centimeters.); and comprises a surface area within a range of 0.2-1 square centimeters (see [0135: last sentence] “the cathode and/or anode exhibits a generally circular shape having a diameter that is about… about 8 mm to about 1 cm…”, this is equivalent to surface area of 0.50-0.78 square centimeters.) It would have been an obvious design choice to a person of ordinary skill in the art at the time of invention to further modify Cartledge in view of Goodall to adjust the surface area, the motivation for doing so is to for doing so is to optimize sensor size and shape for user comfort. (Goodall: [0168] exhibit a shape and fit that attaches the wearable neural stimulation device to the ear of the subject)
Claim 18 is rejected by Cartledge in view of Dietrich and Goodall under the same rationale as discussed to claim 5 above.
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 SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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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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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
August 21, 2026
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