DETAILED ACTION
This action is pursuant to the claims filed on 07/22/2026. Claims 1-7, 9, 12-20 are pending. A first action on the merits of claims 1-7, 9, 12-20 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, 9, 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunasekar (U.S. PGPub No. 2020/0237249) in view of Shakour (U.S. PGPub No. 2019/0328261).
Regarding claim 1, Gunasekar teaches A flexible electrode for a clinical equipment and configured to detect electrical signals from a live tissue (see Figs 1-4), the flexible electrode comprising: a plurality of hair electrodes (Fig 4, 10A-D, [0124] bristle electrodes 1006 of electrode tip 144), wherein each of the hair electrodes includes, a non-conductive and flexible hair electrode base defining a structure of the hair electrode ([0124] bristles include gold plated silicone bristles; silicone is non-conductive flexible base); and a gold outer layer covering the electrode base ([0124] gold plating), the gold outer layer forming a conductive portion of the hair electrode and configured to detect the electrical signals from the live tissue ([0124] gold plating of bristle electrodes are for detecting signals from tissue); the flexible electrode being a three-dimensional electrode (electrode is a 3D electrode).
Gunasekar fails to teach wherein the plurality of hair electrodes are rolled together to form the flexible electrode.
In related prior art, Shakour teaches wherein the plurality of hair electrodes are rolled together to form the flexible electrode (Fig 18, [0140], electrode cluster 72 is braided, twisted together, or otherwise interwoven or interlocked; [0072] defines each strand electrode 12 being non-conductive and coated with a conductive material similar to the prongs of Gunasekar), the flexible electrode being a three-dimensional electrode (electrode cluster 72 defines a 3-D electrode). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prongs of Gunasekar in view of Shakour to incorporate the prongs as a plurality of hair electrodes rolled together to form the flexible electrode to arrive at claim 1. Doing so would be obvious to one of ordinary skill in the art as the rolling, twisting, or braiding of a plurality of hair electrodes to form a flexible electrode is well-known in the art (Shakour Fig 18 electrode cluster 72) to yield the predictable result of providing a flexible electrode for physiological monitoring ([0140], Fig 18 disclosing plurality of interchangeable configurations of flexible electrodes for recording signals).
Regarding claim 2, Gunasekar teaches wherein the hair electrode has a shape comprising at least one of spherical, conical, cubical, or rectangular ([0206] electrode legs 1006 are shaped as elongate cuboids).
Regarding claim 3, Gunasekar teaches wherein a tip of the hair electrode has a shape comprising at least one of spherical, conical, cubical, or rectangular (Fig 10A electrode tip 1008 is spherical).
Regarding claim 4, Gunasekar teaches hair electrode base comprises a flexible pillar (Fig 10A electrode leg 1006 defines flexible pillar base; Fig 16 shows electrode leg 1006 flexing under compression force).
Regarding claim 5, in view of claim 1 above, Shakour teaches wherein the hair electrode base comprises a flexible tube ([0072] strand electrodes 12 are flexible and define a tube shape base that can be hollow [0015]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible base of Gunasekar in view of Shakour to incorporate the flexible base as a flexible tube to arrive at claim 5. Doing so would advantageously enable the hair electrodes to receive and hold a conductive fluid within the electrode to increase electrode-skin conductivity for better signal acquisition.
Regarding claim 6, Gunasekar teaches wherein the hair electrode base is formed by at least one of a polymer ([1024] silicone), cellulose, chitin, chitosan, synthetic flexible fiber, microfiber, nanotube, nanofiber, or parylene.
Regarding claim 9, Gunasekar/Shakour teaches the device of claim 1.
Shakour further teaches wherein the rolling comprises at least one of: rolling a conductive film where the plurality of hair electrodes are attached to, rolling a flexible substrate attached to the plurality of hair electrodes prior to an application of the gold outer layer ([0140] electrode cluster 72 is braided, twisted together, or otherwise interwoven or interlocked; examiner notes “rolling” is a product by process limitation and “If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”; in this case, the product as claimed is made obvious by the prior art since the product is taught in the prior art, such that the specific claimed method of “rolling” need not be taught to reject the claim), or rolling a flexible substrate attached to the plurality of hair electrodes after the application of the gold outer layer. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prongs of Gunasekar in view of Shakour to incorporate the prongs as a plurality of hair electrodes rolled together to form the flexible electrode to arrive at claim 9. Doing so would be obvious to one of ordinary skill in the art as the rolling, twisting, or braiding of a plurality of hair electrodes to form a flexible electrode is well-known in the art (Shakour Fig 18 electrode cluster 72) to yield the predictable result of providing a flexible electrode for physiological monitoring ([0140], Fig 18 disclosing plurality of interchangeable configurations of flexible electrodes for recording signals).
Regarding claim 12, Gunasekar teaches wherein each of the hair electrodes is formed by at least one of: laser cutting, laser marking, water jet cutting, diamond cutting, or injection molding ([0179] entire electrode formed by injection molding).
Regarding claim 13, Gunasekar teaches a holder holding the plurality of hair electrodes together (Figs 10A-D, electrode tip body 1000 functions to hold each leg 1006 together), the holder formed by at least one of: thermal plastic elastomer, elastomer, polymer, 2-dimensional printed structure, 3-dimensional printed structure, or fabric (body 1000 formed from polymer [0179]).
Regarding claim 14, Gunasekar teaches an amplifier configured to amplify the detected electrical signals ([0124] disclosing amplifier).
Regarding claim 15, Gunasekar teaches wherein the flexible electrode forms a passive electrode (electrode is a passive sensing electrode [0144]).
Regarding claim 16, Gunasekar teaches configured to transmit the detected electrical signals wirelessly ([0167] disclosing wireless signal transmission).
Regarding claim 17, Gunasekar teaches configured to transmit the detected electrical signals through a wire ([0168]).
Claim(s) 7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunasekar in view of Shakour and Kumar Ghosh (U.S. PGPub No. 2016/0231269).
Regarding claim 7, Gunasekar/Shakour teaches the device of claim 1 as stated above.
Gunasekar fails to teach wherein the gold outer layer is formed by at least one of: sputtering gold on the hair electrode base, thermally depositing gold on the hair electrode base, electrochemically depositing gold on the hair electrode base, dipping the hair electrode base on a gold metal paste, adding gold nanotubes on the hair electrode base, or adding gold nanoparticles on the hair electrode base.
In related prior art, Kumar Ghosh teaches a similar device wherein a similar gold plating is applied via sputtering ([0058] disclosing sputter coating). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gold plating of Gunasekar in view of Shakour and Kumar Ghosh to incorporate the gold-plating via sputter coating to arrive at claim 7. Doing so would be obvious to one of ordinary skill in the art as sputter coating is a well-known application technique for providing a gold coating on a substrate to yield predictable results therein.
Regarding claim 20, Gunasekar teaches A method of manufacturing a flexible electrode for a clinical equipment and configured to detect electrical signals from a live tissue (see Figs 1-4), the flexible electrode comprising a plurality of hair electrodes (Fig 4, 10A-D, [0124] bristle electrodes 1006 of electrode tip 144), the method comprising: fabricating a plurality of non-conductive hair electrode bases for the plurality of hair electrodes ([0124] bristles include gold plated silicone bristles; silicone is non-conductive flexible base that is fabricated); sputtering a metal on the plurality of hair electrode bases to form conductive portions of the plurality of hair electrodes ([0124] gold plating of bristle electrodes are for detecting signals from tissue); forming the flexible electrode as a three dimensional electrode (electrode is a 3D electrode).
Gunasekar fails to teach the metal provided on the hair electrodes via sputtering.
In related prior art, Kumar Ghosh teaches a similar device wherein a similar gold plating is applied via sputtering ([0058] disclosing sputter coating). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gold plating of Gunasekar in view of Kumar Ghosh to incorporate the gold-plating via sputtering. Doing so would be obvious to one of ordinary skill in the art as sputter coating is a well-known application technique for providing a gold coating on a substrate to yield predictable results therein.
Gunasekar fails to teach rolling the plurality of hair electrode bases with the sputtered metal to form the flexible electrode.
In related prior art, Shakour teaches wherein the plurality of hair electrodes are rolled together to form the flexible electrode (Fig 18, [0140], electrode cluster 72 is braided, twisted together, or otherwise interwoven or interlocked; [0072] defines each strand electrode 12 being non-conductive and coated with a conductive material similar to the prongs of Gunasekar), the flexible electrode being a three-dimensional electrode (electrode cluster 72 defines a 3-D electrode). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prongs of Gunasekar in view of Khumar Ghosh and Shakour to incorporate the prongs with sputtered gold coatings as a plurality of hair electrodes rolled together to form the flexible electrode to arrive at claim 20. Doing so would be obvious to one of ordinary skill in the art as the rolling, twisting, or braiding of a plurality of hair electrodes to form a flexible electrode is well-known in the art (Shakour Fig 18 electrode cluster 72) to yield the predictable result of providing a flexible electrode for physiological monitoring ([0140], Fig 18 disclosing plurality of interchangeable configurations of flexible electrodes for recording signals).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunasekar in view of Shakour and in further view of Cui (U.S. PGPub No. 2009/0005667).
Regarding claims 18-19, Gunasekar teaches A flexible electrode configured for a clinical equipment and configured to detect electrical signals from a live tissue (see Figs 1-4), the flexible electrode comprising: a plurality of hair electrodes (Fig 4, 10A-D, [0124] bristle electrodes 1006 of electrode tip 144), wherein each of the hair electrodes comprises: a non-conductive and flexible hair electrode base defining a structure of the hair electrode ([0124] bristles include gold plated silicone bristles; silicone is non-conductive flexible base); and a conductive outer layer covering the electrode base, the conductive outer layer forming a conductive portion of the hair electrode and configured to detect the electrical signals from the live tissue ([0124] gold plating of bristle electrodes are for detecting signals from tissue); the flexible electrode being a three-dimensional electrode (electrode is a 3D electrode).
Gunasekar fails to teach wherein the plurality of hair electrodes are rolled together to form the flexible electrode.
In related prior art, Shakour teaches wherein the plurality of hair electrodes are rolled together to form the flexible electrode (Fig 18, [0140], electrode cluster 72 is braided, twisted together, or otherwise interwoven or interlocked; [0072] defines each strand electrode 12 being non-conductive and coated with a conductive material similar to the prongs of Gunasekar), the flexible electrode being a three-dimensional electrode (electrode cluster 72 defines a 3-D electrode). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prongs of Gunasekar in view of Shakour to incorporate the prongs as a plurality of hair electrodes rolled together to form the flexible electrode. Doing so would be obvious to one of ordinary skill in the art as the rolling, twisting, or braiding of a plurality of hair electrodes to form a flexible electrode is well-known in the art (Shakour Fig 18 electrode cluster 72) to yield the predictable result of providing a flexible electrode for physiological monitoring ([0140], Fig 18 disclosing plurality of interchangeable configurations of flexible electrodes for recording signals).
Gunasekar fails to teach wherein the conductive outer layer is a polymer; electrochemically depositing a conductive polymer on the hair electrode base, dipping the hair electrode on a conductive polymer paste, adding conductive polymer nanotubes on the hair electrode base, or adding conductive polymer nanoparticles on the hair electrode base.
Cui teaches a similar device wherein an electrode element includes a conductive polymer coating ([0086] [0160] Fig 16A-B conductive polymer coating 712); electrochemically depositing a conductive polymer on the hair electrode base (examiner notes this limitation is a product-by-process limitation, and, in this case, the product in the claim (conductive polymer deposited on hair electrode base) is obvious form the prior art, thus the specific process need not be taught to reject the claim). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gold material of Gunasekar in view of Shakour and Cui to incorporate the conductive polymer deposited coating to arrive at claims 18-19. Doing so would be a simple substation of one well-known conductive material (Gunasekar, gold coating) for another well-known conductive material (Cui conductive polymer coating 712) to yield the predictable result of a conductive coating capable of conducting electrical signals from a user.
Response to Arguments
Applicant’s arguments, see remarks, filed 07/22/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the Shakour reference.
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 Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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