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 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 8-16 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 claims 8-16, these claims recite “said at least first electrode” and/or “said at least second electrode”, these limitations lack proper antecedent basis in claim; because claim 1 discloses “at least one electrode” and “at least one return electrode.” For purpose of examination, the Examiner interprets “said at least first electrode” to refer to “at least one electrode” in claim 1, and “said at least second electrode” to refer to “at least one return electrode” in claim 1. The Applicant’s is required to amend terminology in claims 8-16 for proper antecedent basis.
Claim 12 recites “wherein said at least first electrode is operative to provide stimulation while a subject is asleep”; this limitation is indefinite because neither claim 12, nor independent claim 1, discloses a (structural) limitation capable of providing stimulation. The Applicant is reminded that claim 1 discloses a device that comprises “at least one electrode” and “at least one return electrode”, there is no structure such as a stimulation energy source or circuitry capable of providing said recited “stimulation.”
Regarding claim 15, the claim recites “wherein said second electrode is positioned on the skin surface at an interface between the ear and a head of the subject”, the underlined limitation is indefinite because there are both ears on a head, as such, it is unclear to the Examiner what or which anatomical feature is “an interface between the ear and a head” as recited in this claim. See ‘Claim Interpretation’ section below.
Claim Interpretation
Regarding claim 12, the limitation “while a subject is asleep” imparts no structural feature, it is treated as intended use or functional features of the “first electrode” as drafted in the claim.
Regarding claims 13-15, these claims recite limitations pertaining to the placement of a “second electrode”, these limitations do not impart any structural features and are currently treated as intended use or functional features of the “second electrode” as drafted in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 9-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodall et al. US 2019/0046794 A1 (hereinafter “Goodall”).
Regarding claim 1, Goodall 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)”)
Regarding claim 2, Goodall discloses the electrode configuration according to claim 1, 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)
Regarding claim 3, Goodall discloses the electrode configuration according to claim 1, wherein said at least one return electrode (anode) comprises a circular shape to facilitate positioning said at least second electrode within the ear canal. ([0135: last sentence] “In an embodiment, the cathode and/or anode exhibits a generally circular shape” Also see Fig.3A and [0173] for replacement of electrodes within in the ear canal.)
Regarding claim 4, Goodall discloses the electrode configuration according to claim 1, wherein said at least one electrode comprises a surface area within a range of 0.5-2 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.)
Regarding claim 5, Goodall discloses the electrode configuration according to claim 1, 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.)
Regarding claim 6, Goodall discloses the electrode configuration according to claim 1, wherein said at least one electrode 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)
Regarding claim 7, Goodall discloses the electrode configuration according to claim 1, wherein said at least one electrode (cathode) is customizable to fit ear Cavum Concha area. (see [0168] adapting the size, shape and dimensions or attachment mechanism of the neural stimulation device and corresponding electrodes such that it can be worn in a certain orientation relative to the ear, also see [0135:1st sentence] cathode electrode is adapted to be positioned to contact cavum concha)
Regarding claim 9, Goodall discloses the electrode configuration according to claim 1, wherein said at least first electrode (cathode) and said at least second electrode (cathode) are flexible. (See [0465] electrode skeleton can be form of a semi-flexible material, e.g. urethane)
Regarding claim 10, Goodall discloses the electrode configuration according to claim 1, wherein said at least first electrode (cathode) is a Transcutaneous electrical nerve stimulation (TENS) electrode. ([0134:1st sentence] “neural stimulator 212 includes a transcutaneous electrical stimulator for delivering a transcutaneous electrical stimulus.” The neural stimulator is adapted to output TENS stimulation through the anode and cathode electrodes as discussed in [0135], therefore the anode and cathode electrodes encompasses “TENS electrode” as recited in this claim)
Regarding claim 11, Goodall discloses the electrode configuration according to claim 1, wherein said at least second electrode (anode) is a Transcutaneous electrical nerve stimulation (TENS) electrode. ([0134:1st sentence] “neural stimulator 212 includes a transcutaneous electrical stimulator for delivering a transcutaneous electrical stimulus.” The neural stimulator is adapted to output TENS stimulation through the anode and cathode electrodes as discussed in [0135], therefore the anode and cathode electrodes encompasses “TENS electrode” as recited in this claim)
Regarding claim 12, Goodall discloses the electrode configuration according to claim 1, wherein said at least first electrode is operative to provide stimulation while a subject is asleep. ([0134-0135] the anode and cathode electrode provide stimulation, and also see [0128-0129, 0165-0166] Goodall discloses the device can be used to address sleeping disorder by providing stimulation to symptoms that occur during sleep, this is taken to meet the intended use of the “first electrode” recited in this claim.)
Regarding claim 13, Goodall discloses the electrode configuration according to claim 1, wherein said second electrode is positioned on the skin surface of rear region of the ear. (The recited limitations in this claim is treated as intended use of the “second electrode.” Goodall discloses possible placement of an anode electrode in anatomical regions labeled in Fig. 1, which include the posterior surface of pinna 106, see [0175], this is taken to encompass “skin surface of rear region of the ear” in this claim. Alternatively, Figs. 3B and 3C illustrated embodiments in which electrodes can be placed in said “rear region of the ear”)
Regarding claim 14, Goodall discloses the electrode configuration according to claim 1, wherein said second electrode is positioned on the skin surface of rear region of a head of the subject. (The recited limitations in this claim is treated as intended use of the “second electrode.” Goodall [0183: last sentence] discloses placement of stimulating electrodes on the surface of the head adjacent the pinna/back of ear, this is taken to encompass “on the skin surface of rear region of a head of the subject” as recited in this claim)
Regarding claim 15, Goodall discloses the electrode configuration according to claim 1, wherein said second electrode is positioned on the skin surface at an interface between the ear and a head of the subject. (The recited limitations in this claim is rejected under 35 USC 112(b) indefinite treated as intended use of the “second electrode.” Goodall discloses a plurality of placement of stimulation electrodes around and inside an ear, and on the back of the head near the pinna of ear, as shown in Fig. 1 and [0136], additional placements of electrodes are further explained in [0192] including temple; alternatively, [0176] and Fig. 3C illustrates electrodes 314/330C held on flexible extensions 334’ and thus would allow the electrodes to be placed in any desired location around the ear and head.)
Regarding claim 17, Goodall 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 (anode stimulator/electrode) operative to be adhered to a first portion of inner skin surface of an ear of the subject ([0135:3nd sentence] “… In another embodiment, the anode of the neural stimulator 212 can be configured to be positioned to contact the concha of the pinna…” Also see [0198:5th sentence] attachment mechanism including adhesives); and,
at least one return electrode (cathode stimulator/electrode) with an opposite polarity operative to be adhered on a skin area of a rear region of the ear ([0135:3nd sentence] “…and the cathode can be configured to be positioned on a corresponding portion of the posterior surface of the pinna.”).
Regarding claim 18, Goodall discloses the electrode configuration according to claim 17, 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.)
Regarding claim 19, Goodall discloses the electrode configuration according to claim 17, wherein said at least one electrode (anode) is customizable to fit regions of ear. (See [0168] adapting the size, shape and dimensions or attachment mechanism of the neural stimulation device and corresponding electrodes such that it can be worn in a certain orientation relative to the ear, also see [0135:1st sentence] cathode electrode is adapted to be positioned to contact cavum concha)
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cartledge et al. US 2017/0087364 A1 (hereinafter “Cartledge”).
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 operative (anode/positive electrode; see [300] and [0464: last sentence]) 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,
at least one return electrode with an opposite polarity (cathode/negative electrode; [0464: last sentence]) operative to be adhered to a second portion of a skin surface of the subject (see Fig. 5, electrode 8 placed on back of ear; see [0253-0256]).
Regarding claim 8, Cartledge discloses the electrode configuration according to claim 1, wherein said at least first electrode 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)
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Goodall as applied to claim 1 above.
Regarding claim 16, Goodall discloses the electrode configuration according to claim 1 comprising at least two electrodes, i.e. anode and cathode, carried by an ear worn device such that the electrodes are positioned for stimulation of anatomical regions in and around the ear, including the cavum concha, as shown in Fig. 1 and [0135-0136, 0173]. Goodall does not explicitly disclose wherein said first electrode comprises a surface area greater than 50% of the skin surface of the Cavum Concha. However, Goodall explicitly discloses that “the wearable neural stimulation device 202 can exhibit a shape, size, or attachment mechanism that allows the wearable neural stimulation device 202 to at least one of be worn only in a certain ear 204, be worn in a certain orientation relative to the ear 204, or allow the wearable neural stimulation device 202 to be easily removed from the ear 204 (e.g., using a single action)” ([0168]). Goodall, in [0169] further discloses a range of sizes for the housing, ranging from height of 1cm to 7cm, width of 1cm to 6cm, and thickness of 0.25cm to 3cm. Based on these possible size and shape disclosed adjustments, it would have been an obvious design choice to a person of ordinary skill in the art at the time of invention to configure Goodall’s first electrode, to comprises a surface area greater than 50% of the skin surface of the Cavum Concha, the motivation for doing so is routine adjustment of sizes and shapes to find the best fit for a user’s particular ear anatomy.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Goodall.
Regarding claim 30, Goodall discloses a method of positioning an electrode on a skin surface area of an ear (Abstract), the method comprising:
positioning said electrode (anode or cathode electrode) on the skin surface area ([0135-0136] placing electrodes in and around the skin surface area of the ear, such as shown in anatomical locations illustrate in Fig.1);
measuring an impedance to determine whether said electrode is properly positioned (see Fig. 49 and [0384-0385] determine proper/improper placement of the one or more electrodes: “contact determination circuitry 4916 is configured to determine an electrical impedance between the at least one first electrode 4906 and the at least one second electrode 4908.” See [0388] outputting contact signal quality and advice to clean device so as to get good electrode contact. Also see Fig. 51 and [0390] “determining an electrical impedance between the at least one first electrode and the at least one second electrode…” determining the first electrode is in good electrical contact based on amplitude of the impedance signal);
connecting said electrode to a stimulator (see Fig. 49: electrodes 4906, 4908 are connected to stimulator, i.e. ear stimulation device control system 4904); and,
delivering an electrical stimulation to the ear ([0134, 0137] delivering a transcutaneous electrical stimulus to the ear).
Goodall does not explicitly disclose the step of cleaning a skin surface area prior to all the above steps. 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. Since Goodall 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 Goodall’s stimulator electrode and device as discussed in [0134-0136].
Conclusion
Note to Applicant: The Applicant’s US-based contact numbers are not in service. Please update contacts accordingly.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Wetmore et al. US 2022/0160995 A1 discloses an ear worn device neurostimulation device comprising a cathode and anode electrodes, see [0087] Figs. 9-11C.
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
February 5, 2026