DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 14, 2025 has been entered.
This action is pursuant to the claims filed on November 14, 2023. Claims 1-7, 9-16, and 18-23 are pending. Claims 8 and 17 is/are canceled. A complete action on the merits of claims 1-7, 9-16, and 18-23 is as follows.
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 . 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 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.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7, 10-13 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Berezovsky et al. (hereinafter ‘Berezovsky’, NPL: Validation of a new fiber electrode prototype for clinical electroretinography, see IDS), in view of Woo et al. (hereinafter ‘Woo’, NPL: The DTL electrode comes in different shapes and sizes: Are they all good?), in view of in view of Gekeler et al. (hereinafter ‘Gekeler’, U.S. PGPub. No. 2013/0066396), and further in view of Hawlina (U.S. Pat. No. 5,154,174, see IDS).
In regards to independent claims 1, and claim 2, 7, 10-12, Berezovsky discloses an apparatus for use in performing electroretinography on a test subject (see Fig. 1), the apparatus comprising:
at least one electrically conductive thread (fiber electrode as shown in annotated Fig. 1; Methods, Reference-coupled disposable fiber electrodes: the monofilament is impregnated with metallic silver), the at least one electrically conductive thread comprising a first end (an end of the fiber electrode attached to the first sticky pad), a second end (the other end of the fiber electrode attached to the second sticky pad) and a central portion extending between the first end and the second end (the portion between the end and the other end of the fiber electrode);
wherein the first end is configured to mount to skin on one side of an eye of the test subject using a first sticky pad (the first sticky pad holds the end of the fiber electrode and is positioned on one side of the eye) and the second end is configured to mount the skin on the opposite side of the eye of the test subject (the second sticky pad holds the other end of the fiber electrode and is positioned on the other side of the eye), such that the central portion is in contact with a surface film of the eye of the test subject (Methods, Reference-coupled disposable fiber electrodes: the fiber electrode is positioned in the lower conjunctival sac as shown in Fig. 1 below); and
wherein the first and second sticky pads are electrically isolated from the skin (Methods, Reference-coupled disposable fiber electrodes: small non-conductive sponges are secured to the skin via double-sided adhesive tape).
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However, Berezovsky does not disclose a plurality of flexible threads coated with an electrically conductive material so as to form a plurality of flexible electrically conductive threads.
Woo teaches various DTL fiber electrode configured for ERG recording. Note that Berezovsky is also a DTL fiber electrode. Specifically, Woo conducted an experiment with five types of yarns of DTL electrodes including using 7, 2 or 1 threads (pg. 156, col. 2, DTL fiber electrodes, see Fig. 1a & 1b). Woo explains that parameters of the ERG waveforms such as amplitude, peak time, frequency composition or noise contamination were no different in the various types of DTL electrodes in the study (pg. 161, Discussion, para. 1). However, DTL electrode with 7 threads provided the least crimping (pg. 159, Results, para. 1) and most comfort (pg. 161, Discussion, para. 1) over other DTL fiber electrode including two of the DTL fiber electrode comprising a single conductive thread. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the electrically conductive thread of Berezovsky with a plurality of flexible electrically conductive threads as taught by Woo, thereby arriving at the claimed invention. Doing so does not change any parameters of the ERG waveform but provides more comfort to the patient and less crimping compared to the single thread DTL electrode (pg. 161, Discussion, para. 1).
However, Berezovsky/Woo combination fails to disclose an electrically non-conductive coating applied to at least one of the first end of the plurality of flexible electrically conductive threads and the second end of the plurality of flexible electrically conductive threads so as to bundle the flexible electrically conductive threads together and electrically isolate the bundled plurality of flexible electrically conductive threads from the eye of the test subject.
Gekeler teaches an electrode formed from a plastic thread coated with an inert material similar to Woo and configured to be positioned on a patient’s eye for stimulation (see Fig. 3, [0110]). Gekeler further discloses ends of the DTL electrode comprises tubular covering or coating so that only a central portion comprises an exposed conductive thread to be disposed on a corneal surface for handling ([0111]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conductive threads of Berezovsky/Woo combination and provide a non-conductive coating as taught by Gekeler to provide mechanical rigidity and for the hygiene purposes so that the user does not come into contact with the central portion of the conductive thread while gasping and holding the ends of the thread ([0114]).
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The examiner notes that Berezovsky/Woo/Gekeler combination discloses substantially all the limitations of the claim(s) except that the electrically non-conductive coating forms a bundle thread. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the invention to either coat each end of the plurality of conductive threads or combine the ends of the conductive threads and coat to form a bundle thread, since doing so is merely one of two possibilities from which one of ordinary skill in the art would select for handling purposes of the conductive threads. Combining multiple conductive threads simplifies the overall design of the DTL electrode for handling purposes.
However, Berezovsky/Woo/Gekeler combination is silent as to the material of the tubular cover/coating surrounding the ends of the conductive thread.
Hawlina teaches an apparatus for electroretinography on a test subject formed from an electrode formed from a conductive thread (electrode 1 formed from silver wire 2) for positioning along an eye, wherein the conductive thread is insulated with a non-conductive coating, polytetrafluoroethylene or Teflon, except in a central region of the conductive thread (col. 3, ln. 59-col. 4, ln. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the tubular cover/coating surrounding the ends of the conductive threads of Berezovsky/Woo/Gekeler combination with polytetrafluoroethylene or Teflon as taught by Hawlina, as doing so prevents potential loss of signal due to contact with surrounding skin and excessive pick-up of muscular noise, thus ensuring that the signal obtained is of relatively large amplitude and is very consistent (col. 4, ln. 60-65). Note that the coating of Teflon along the opposite ends of the conductive thread inherently provides a stiffening property to the ends of the conductive threads and the modified first and second ends of the bundled thread are configured to be mounted to the skin as shown by Berezovsky.
In regards to claim 3, Berezovsky/Woo/Gekeler/Hawlina combination further discloses wherein the second sticky pad comprises an electrical cable connector electrically connected to the second end (sponge located on the side of the eye closes to the nose is shown connecting the fiber electrode to an electrical cable in Fig. 1), and further wherein the electrical cable connector is configured to receive a lead connector to external electronics (the sponge is shown receiving a lead that is connected to VERIS 5.1.9 (external electronics); Fig. 1; pg. 317, col. 2, para. 2-3).
In regards to claim 4, Berezovsky/Woo/Gekeler/Hawlina combination further discloses wherein the external electronic comprises at least one selected from the group consisting of an amplifier, a controller and a computer (VERIS 5.1.9 (computer), pg. 317, col. 2, para. 2-3).
In regards to independent claim 13, Berezovsky/Woo/ Gekeler/Hawlina combination providing the apparatus as claimed and as explained in claim 1 above. Berezovsky further discloses
mounting the first end of the at least one electrically conductive thread to the skin on one side of an eye of the test subject (sponge located on the side of the eye closes to the nose is shown connecting the fiber electrode to an electrical cable in Fig. 1), and
mounting the second end of the at least one electrically conductive thread to the skin on the opposite side of the eye of the test subject, such that the at least one electrically conductive thread is electrically isolated from the skin (the sponge receiving a lead that is connected to VERIS 5.1.9 (external electronics); Fig. 1; pg. 317, col. 2, para. 2-3), and such that at least one region of the electrically conductive thread is in electrical contact with the eye of the test subject (the modified Berezovsky/Hawlina fiber electrode comprises exposed conductive portion for contacting the eyeball).
In regards to independent claim 20-21, Berezovksy discloses an apparatus for use in performing electroretinography on a test subject (see Fig. 1), the apparatus comprising:
a sticky pad comprising a top surface and a bottom surface (Methods, Reference-coupled disposable fiber electrodes: small non-conductive sponges are secured to the skin; note that the fiber electrode is disposed between two sponges each having a top and bottom surface);
wherein the bottom surface of the sticky pad comprises an adhesive for mounting the sticky pad to skin of the test subject (Methods, Reference-coupled disposable fiber electrodes: small non-conductive sponges are secured to the skin via double-sided adhesive tape);
wherein the sticky pad is defined by a plane having a non-circular perimeter (the shape of the sponges is a square).
Berezovsky fails to disclose the non-circular perimeter comprising a wide portion and a narrow portion, wherein the wide portion is configured to be positioned adjacent to the temple of the test subject, and the narrow portion is configured to guide a conductive thread mounted to the sticky pad toward the eye of the test subject. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to modify the shape of the sticky pad to be circular, rectangular, quadrilateral, trapezoidal or triangular, since applicant has not disclosed that any of these shapes solve any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with for holding the conductive thread and adhering onto the skin. It is noted that the triangular, trapezoidal or quadrilateral shapes have a varying width and is capable of allowing the tapering width portion to guide the conductive thread.
However, Berezovsky does not disclose a plurality of flexible threads coated with an electrically conductive material so as to form a plurality of flexible electrically conductive threads.
Woo teaches various DTL fiber electrode configured for ERG recording. Note that Berezovsky is also a DTL fiber electrode. Specifically, Woo conducted an experiment with five types of yarn of DTL electrodes including using 7, 2 or 1 threads (pg. 156, col. 2, DTL fiber electrodes, see Fig. 1a & 1b). Woo explains that parameters of the ERG waveforms such as amplitude, peak time, frequency composition or noise contamination were no different in the various types of DTL electrodes in the study (pg. 161, Discussion, para. 1). However, DTL electrode with 7 threads provided the least crimping (pg. 159, Results, para. 1) and most comfort (pg. 161, Discussion, para. 1) over other DTL fiber electrode including two of the DTL fiber electrode comprising a single conductive thread. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the electrically conductive thread of Berezovsky with a plurality of flexible electrically conductive threads as taught by Woo, thereby arriving at the claimed invention. Doing so does not change any parameters of the ERG waveform but provides more comfort to the patient and less crimping compared to the single thread DTL electrode (pg. 161, Discussion, para. 1).
However, Berezovsky fails to disclose an electrically non-conductive coating applied to at least one of the first end of the plurality of flexible electrically conductive threads and the second end of the plurality of flexible electrically conductive threads so as to bundle the flexible electrically conductive threads together and electrically isolate the bundled plurality of flexible electrically conductive threads from the eye of the test subject.
Gekeler teaches an electrode formed from a plastic thread coated with an inert material similar to Woo and configured to be positioned on a patient’s eye for stimulation (see Fig. 3, [0110]). Gekeler further discloses ends of the DTL electrode comprises tubular covering or coating so that only a central portion comprises an exposed conductive thread to be disposed on a corneal surface for handling ([0111]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conductive threads of Berezovsky/Woo combination and provide a non-conductive coating as taught by Gekeler to provide mechanical rigidity and for the hygiene purposes so that the user does not come into contact with the central portion of the conductive thread while gasping and holding the ends of the thread ([0114]).
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The examiner notes that Berezovsky/Woo/Gekeler combination discloses substantially all the limitations of the claim(s) except that the electrically non-conductive coating forms a bundle thread. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the invention to either coat each end of the plurality of conductive threads or combine the ends of the conductive threads and coat to form a bundle thread, since doing so is merely one of two possibilities from which one of ordinary skill in the art would select for handling purposes of the conductive threads. Combining multiple conductive threads simplifies the overall design of the DTL electrode for handling purposes.
However, Berezovsky/Woo/Gekeler combination is silent as to the material of the tubular cover/coating surrounding the ends of the conductive thread.
Hawlina teaches an apparatus for electroretinography on a test subject formed from an electrode formed from a conductive thread (electrode 1 formed from silver wire 2) for positioning along an eye, wherein the conductive thread is insulated with a non-conductive coating, polytetrafluoroethylene or Teflon, except in a central region of the conductive thread (col. 3, ln. 59-col. 4, ln. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the tubular cover/coating surrounding the ends of the conductive threads of Berezovsky/Woo/Gekeler combination with polytetrafluoroethylene or Teflon as taught by Hawlina, as doing so prevents potential loss of signal due to contact with surrounding skin and excessive pick-up of muscular noise, thus ensuring that the signal obtained is of relatively large amplitude and is very consistent (col. 4, ln. 60-65). Note that the coating of Teflon along the opposite ends of the conductive thread inherently provides a stiffening property to the ends of the conductive threads and the modified first and second ends of the bundled thread are configured to be mounted to the skin as shown by Berezovsky.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Berezovsky, Woo, Gekeler and Hawlina as applied to claim 1 above, and further in view of Morgan (U.S. Pat. No. 7,787,950, see IDS).
In regards to claim 6, Berezovsky/Woo/Gekeler/Hawlina combination discloses the invention substantially as claimed in claim 1 and discussed above. However, it is silent as to the electrically non-conductive coating comprising silicone.
Morgan teaches various materials for electrically non-conductive coating to electrically isolate or insulate specific regions along a lead body, including ethylene tetrafluoroethylene, polytetrafluoroethylene, silicone rubber or polyurethane (col. 2, ln. 48-57). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the Teflon coating of Berezovsky/Woo/Gekeler/Hawlina combination with any of the equivalent insulative materials including silicone rubber as taught by Morgan since the equivalence of Teflon and silicone rubber for their use in the electrode art and the selection of any one of these known equivalents to insulate portions of an electrode wire/lead would be within the level of ordinary skill in the art.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Berezovsky, Woo, Gekeler and Hawlina as applied to claim 1 above, and further in view of Dawson (U.S. Pat. No. 4,417,581, see IDS).
In regards to claim 9, Berezovsky/Woo/Gekeler/Hawlina combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Berezovsky/Woo/Gekeler/Hawlina combination does not disclose the claimed length of the first, second and third regions.
Dawson teaches that a conductive thread used for electroretinography is formed from a silver coated nylon fiber (12) which is also used by Berezovsky is approximately 2 cm in length for contacting a surface of the eyeball (col. 2, ln. 59-62). The examiner notes that this length ensures that the conductive thread is in substantial contact with the eyeball during electroretinography. Given that Berezovsky/Woo/Gekeler/Hawlina combination further discloses that the first and second ends are configured to be attached to the skin adjacent to the nose and the temple, it would have been obvious to one of ordinary skill in the art to provide the first, second and third regions having the claimed length as doing so would ensure that the conductive region of the conductive thread is of sufficient length to cover the length of an average patient’s eye while the other ends that are not in contact with the eye are insulated. Furthermore, the first end would be substantially less since the conductive thread is attached to the nose which is closer in distance to the eye than the second end which is attached to the temple of the skin, a further distance requiring a longer length to be insulated. Therefore, providing these lengths of insulation and conductivity involve routine skilled in the art based upon the anatomy of the patient, 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.
Claims 14-16, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (WO 2019/052239, see IDS), in view of Woo, in view of Gekeler, and further in view of Hawlina.
In regards to independent claim 14, Zhao discloses an apparatus for use in performing electroretinography on a test subject (abstract, active electrode detection device for electroretinography), the apparatus comprising:
at least one electrically conductive thread (electrode 4 as a thread contacting the conjunctiva of the eye as shown in Figs. 2 & 5), the at least one electrically conductive thread comprising a first end and a second end (ends of the electrode 4 attached to pads 4 & 5), the plurality of flexible electrically conductive threads each comprising a first end, a second end and a central portion extending between the first end and the second end (the portion between the ends of the electrode 4), wherein the first end of the at least one electrically conductive thread is configured to mount to a first sticky pad (first end of the electrode is shown mounted to electrode 4 that attaches to the skin on a first side of the eye) and the second end of the at least one electrically conductive thread is configured to mount to a second sticky pad (second end of the electrode is shown mounted to electrode 5 that attaches to the skin on a second side of the eye),
wherein the first sticky pad is configured to mount to skin on one side of an eye of the test subject, and the second sticky pad is configured to mount to skin on the opposite side of the eye of the test subject (electrodes 4 & 5 adhere to the skin),
wherein the second sticky pad comprises a top surface and a bottom surface (electrode 5 comprises top surface and bottom surface), and further wherein the second sticky pad comprises a conductive element mounted to the bottom surface (the bottom surface of electrode 5 is conductive), whereby to make electrical contact with the skin when the second sticky pad is mounted to the skin (electrode 5 is configured to make an electrical contact for EOG recording).
However, Zhao does not disclose a plurality of flexible threads coated with an electrically conductive material so as to form a plurality of flexible electrically conductive threads.
Woo teaches various DTL fiber electrode configured for ERG recording. Note that Zhao is also a DTL fiber electrode. Specifically, Woo conducted an experiment with five types of yarn of DTL electrodes including using 7, 2 or 1 threads (pg. 156, col. 2, DTL fiber electrodes, see Fig. 1a & 1b). Woo explains that parameters of the ERG waveforms such as amplitude, peak time, frequency composition or noise contamination were no different in the various types of DTL electrodes in the study (pg. 161, Discussion, para. 1). However, DTL electrode with 7 threads provided the least crimping (pg. 159, Results, para. 1) and most comfort (pg. 161, Discussion, para. 1) over other DTL fiber electrode including two of the DTL fiber electrode comprising a single conductive thread. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the electrically conductive thread of Berezovsky with a plurality of flexible electrically conductive threads as taught by Woo, thereby arriving at the claimed invention. Doing so does not change any parameters of the ERG waveform but provides more comfort to the patient and less crimping compared to the single thread DTL electrode (pg. 161, Discussion, para. 1).
However, Zhao/Woo combination fails to disclose an electrically non-conductive coating applied to at least one of the first end of the plurality of flexible electrically conductive threads and the second end of the plurality of flexible electrically conductive threads so as to bundle the flexible electrically conductive threads together and electrically isolate the bundled plurality of flexible electrically conductive threads from the eye of the test subject.
Gekeler teaches an electrode formed from a plastic thread coated with an inert material similar to Woo and configured to be positioned on a patient’s eye for stimulation (see Fig. 3, [0110]). Gekeler further discloses ends of the DTL electrode comprises tubular covering or coating so that only a central portion comprises an exposed conductive thread to be disposed on a corneal surface for handling ([0111]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conductive threads of Zhao/Woo combination and provide a non-conductive coating as taught by Gekeler to provide mechanical rigidity and for the hygiene purposes so that the user does not come into contact with the central portion of the conductive thread while gasping and holding the ends of the thread ([0114]).
The examiner notes that Zhao/Woo/Gekeler combination discloses substantially all the limitations of the claim(s) except that the electrically non-conductive coating forms a bundle thread. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the invention to either coat each end of the plurality of conductive threads or combine the ends of the conductive threads and coat to form a bundle thread, since doing so is merely one of two possibilities from which one of ordinary skill in the art would select for handling purposes of the conductive threads. Combining multiple conductive threads simplifies the overall design of the DTL electrode for handling purposes.
However, Zhao/Woo/Gekeler combination is silent as to the material of the tubular cover/coating surrounding the ends of the conductive thread.
Hawlina teaches an apparatus for electroretinography on a test subject formed from an electrode formed from a conductive thread (electrode 1 formed from silver wire 2) for positioning along an eye, wherein the conductive thread is insulated with a non-conductive coating, polytetrafluoroethylene or Teflon, except in a central region of the conductive thread (col. 3, ln. 59-col. 4, ln. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the tubular cover/coating surrounding the ends of the conductive threads of Zhao/Woo/Gekeler combination with polytetrafluoroethylene or Teflon as taught by Hawlina, as doing so prevents potential loss of signal due to contact with surrounding skin and excessive pick-up of muscular noise, thus ensuring that the signal obtained is of relatively large amplitude and is very consistent (col. 4, ln. 60-65). Note that the coating of Teflon along the opposite ends of the conductive thread inherently provides a stiffening property to the ends of the conductive threads and the modified first and second ends of the bundled thread are configured to be mounted to the skin as shown by Berezovsky.
In regards to claim 15, Zhao/Woo/Gekeler/Hawlina combination further discloses an electrical cable connector mounted to the second sticky pad (wire 7 is connected to the EOG electrode 5 via an amplifier 1), the electrical cable connector being in electrical connection with the at least one electrically conductive thread and the conductive element (electrode 5 is electrically connected to the wire 7 via the amplifier 1), and the electrical cable connector being configured to electrically connect to a lead connected to external electronics (the amplifier 1 provides real time data to LCD display screen 8 or other devices including mobile terminals and computers).
In regards to claim 16, Zhao/Woo/Gekeler/Hawlina combination further discloses wherein the electrical cable connector comprises a first channel and a second channel, wherein the first channel is electrically isolated from the second channel, wherein the electrically conductive thread is electrically connected to the first channel, and wherein the conductive element is electrically connected to the second channel (the wires 6 & 7 electrically connected to electrodes 4 and 5 are connected to the amplifier 1; as shown in Fig. 1, the wires extend into the amplifier 1, which inherently requires channels for receiving the wires and the wires 6 & are insulated).
In regards to claim 18, Zhao/Woo/Gekeler/Hawlina combination further discloses wherein the plurality of flexible electrically conductive threads of the central portion is configured to contact the surface film of an eye, whereby to serve as an active electrode for performing electroretinography (electrode 4 in Fig. 2), and further wherein the conductive element is configured to contact the skin, whereby to serve as a reference electrode for performing electroretinography (although not labeled in Fig. 2, Fig. 1 show electrode 2 which serve as a reference electrode).
In regards to independent claim 19, Zhao/Woo/Gekeler/Hawlina combination further discloses a method for use in preforming electroretinography on a test subject, the method comprising:
providing an apparatus as claimed (see rejection of claim 14 above);
mounting the first sticky pad to the skin of a test subject on one side of an eye of the test subject (first end of the electrode is shown mounted to electrode 4 that attaches to the skin on a first side of the eye), and
mounting the second sticky pad to the skin of the test subject (second end of the electrode is shown mounted to electrode 5 that attaches to the skin on a second side of the eye), such that the central portion of the plurality of flexible electrically conductive threads is in electrical contact with the eye of the test subject (the modified central portion of the plurality of threads are configured to contact the cornea of the test subject as shown in Fig. 2 & explained in pg. 1, para. 2: “The positive electrode can be placed on the surface of the eyeball or the corresponding part using a corneal contact or a non-corneal contact electrode”)
eye second end of the electrode is shown mounted to electrode 5 that attaches to the skin on a second side of the eye);
wherein the at least one electrically conductive thread is configured to serve as the active electrode for performing electroretinography (electrode 4 in Fig. 2 operate as active ERG electrode); and
wherein the conductive element is configured to serve as the reference electrode for performing electroretinography (although not labeled in Fig. 2, Fig. 1 shows electrode 2 which serve as a reference electrode; pg. 2, para. 3:” the retina creates a potential that can be perceived by different recordings of different eye electrodes or by the reference electrode of the corner of the eye”).
Response to Arguments
Applicant’s arguments, filed on November 14, 2025, is fully acknowledged.
With respect to the rejection of claims 1-4, 7, 10-13, 20 and 21 under 35 U.S.C. 103 as being unpatentable over Berezovsky, Woo, and Hawlina has been fully considered. Applicant argues that that Zhao, Berezovsky and Hawlina fail to disclose, teach, or suggest, in part, “wherein at least one of the first end and the second end of the plurality of flexible electrically conducive threads comprises an electrically non-conductive coating which forms a bundle thread…” as required in independent claims 1, 13, 14, 19 and 20.
Applicant further argues that Hawlina insulates the entire silver wire (except for two windows) with polythetrafluoroethylene (“TEFLON”) so as to form a self-supporting electrically conductive filament. Therefore, the combination does not provide a central portion having a plurality of flexible electrically conductive threads configured to contact a surface of the eye of the test subject as required in independent claim 1. This argument is persuasive and the rejection has been withdrawn.
Upon further search and/or consideration, Gekeler teaches a DTL electrode formed from a plastic thread coated with an inert material (see Fig. 3, [0110]). Gekeler further discloses a tubular cover/coating disposed at ends of the DTL electrode so that only a central portion is disposed on a corneal surface ([0111]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conductive threads of Berezovsky/Woo combination and provide a non-conductive coating as taught by Gekeler to provide mechanical rigidity and for the hygiene purposes so that the user gasps and holds the ends of the thread instead of the conductive thread portions which would essentially contact the cornea ([0114]).
In addition, the examiner notes that Berezovsky/Woo/Gekeler combination discloses substantially all the limitations of the claim(s) except that the electrically non-conductive coating which forms a bundle thread. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the invention to either cover or coat each ends of the plurality of conductive threads or combine the ends of the conductive threads and coat to form a bundle thread, since doing so is merely one of two possibilities from which one of ordinary skill in the art would select to insulate the ends of the conductive threads and provide stiffening properties at the ends of the conductive threads for handling purposes. Combining multiple conductive threads simplifies the overall design of the DTL electrode for handling purposes.
Lastly, Hawlina is now relied upon for the material for forming the insulative ends.
Furthermore, Applicant’s arguments with respect to claims 2-5, 7, 10-12, 21-23 solely directed towards the secondary references failure to cure the above-noted deficiency of independent claims 1 or 20 are persuasive. Therefore, new grounds of rejections are made in view of Berezovsky, Woo, Gekeler and Hawlina.
Applicant’s argument directed to independent claim 14 in view of Zhao, Woo and Hawlina under 35 U.S.C. 103 has been fully considered. Applicant explains that the combination of references fail to disclose similar structural features as that of independent claim 1. This argument is persuasive and a new ground of rejection is made in view of Gekeler. In addition, Applicant’s arguments with respect to claims 15, 16 and 18 solely directed towards the secondary references failure to cure the above-noted deficiency of independent claim 14 is persuasive. Therefore, a new ground of rejection is made in view of Zhao, Woo, Gekeler and Hawlina.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 12/11/2025