DETAILED ACTION
This action is pursuant to the claims filed on 07/02/2026. Claims 2-28 are pending. A final action on the merits of claims 2-28 is as follows.
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive.
Applicant argues that Bordoley fails to teach “the lumen having a distal opening in the distal tip” and “the conductive fluid or gel to flow from the lumen to the distal opening, and through the distal opening and the distribution channel to a skin surface of a patient”.
Applicant states on page 8 of the remarks, that the Office Action relied upon “the space above frangible seal 406 for support for the claimed lumen, and the delivery channel 418 below the seal 406 for support for the claimed distribution channel.” This is a misinterpretation of the Examiner’s rejection of record.
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Above is an annotation of Figure 4B to assist in the understanding of the claim mapping. The Examiner has relied upon the space below the frangible seal 406 to read upon a lumen in which the conductive gel is configured to flow from the “sealed dispensing container” (above seal 406) to the lumen (below seal 406) after seal 406 is ruptured as claimed. This is reflected on page 4 of the Non-Final Office Action: “examiner notes portion of channel 418 within the tubular member is interpreted as the lumen…” The delivery channel 418 of Bordoley is explicitly disclosed as located below the seal 406. As such, the Applicant’s characterization of the mapping of the non-final Office Action noted above is made in error.
Furthermore, para. [0145] of Bordoley discloses the delivery channel 418 having opening(s) in the distal tip to allow the fluid to flow from the “lumen” to the “opening” and into contact with skin. The “opening” in the distal tip of Fig 4B, necessarily spans the thickness of the distal tip material. The examiner reasonably interprets the ‘beginning’ of the “opening” at the ‘inside’ of the lumen (i.e., delivery channel 418) as the “distal opening” as claimed and shown in the annotation above. This distal opening, then spans across the thickness of the distal tip towards the outside and this spanning is reasonably interpreted as the “distribution channel”. This interpretation reads upon a flow path of the conductive gel to be “from the lumen to the distal opening, and through the distal opening and the distribution channel to a skin surface of a patient” as claimed.
Examiner further notes that the applicant’s arguments against the rejection of record contradict the claimed subject matter. The Applicant states, on pages 8-9, that (emphasis added): “Bordoley’s colloidal paste/gel 420 travels directly from the delivery channel 418 to the distal opening, not from a distal opening to the distribution channel.”
However, the claim recites (emphasis added): “the conductive fluid or gel to flow from the lumen to the distal opening, and through the distal opening and the distribution channel to a skin surface … wherein the conductive fluid or gel enters the distribution channel directly from the lumen.” Based on these arguments, it would be unclear how the gel would enter the distribution channel directly from the lumen, if applicant is arguing that the gel must travel from a distal opening to the distribution channel. Therefore, the Examiner’s above interpretation in which “the distal opening” is contained within the “lumen” reads upon the claimed language given this interpretation allows for the gel to enter “the distribution channel directly from the lumen” as claimed while maintaining the claimed flow path of lumen → distal opening → distribution channel → skin.
Based on the above, the applicant’s arguments to the independent claims are unpersuasive. Applicant’s arguments to the dependent claims are equally unpersuasive for the reasons stated above.
Claim Rejections - 35 USC § 102
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) 2-3, 5, 16-17, 26-27, and 29-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bordoley (U.S. PGPub No. 2012/0143020).
Regarding claim 2, Bordoley teaches An electrode assembly for measuring EEG signals comprising: an electrode body (Fig 3 electrode assemblies 302); one or more tubular members having a distal tip extending from the electrode body, each tubular member comprising a lumen and a distribution channel (Fig 4B tubular member has delivery channel 418 below seal 406; examiner notes portion of channel 418 within the tubular member is interpreted as the lumen and the portion of channel 418 connecting to the exterior is interpreted as the distribution channel), the lumen having a distal opening in the distal tip (Fig 4B and [0145] lumen 418 has opening at distal tip); and a sealed dispensing container containing a conductive fluid or gel (Fig 4B conductive gel sealed behind seal 406), wherein the sealed dispensing container is configured to be ruptured to allow the conductive fluid or gel to flow from the lumen to the distal opening, and through the distal opening and the distribution channel to a skin surface of a patient to form an electrically conductive path ([0145]), and wherein the conductive fluid or gel enters the distribution channel directly from the lumen (Fig 4B, gel 420 goes from delivery channel 418 directly to distribution channels to the exterior of a patient’s scalp).
Regarding claim 3, Bordoley teaches wherein the electrode body is rotatably mounted to a headband ([0167] discloses rotation by ¼ turn to engage and lock electrode body in a position to be in contact with the scalp; Fig 3 shows mounting of electrode bodies to a headband).
Regarding claim 5, Bordoley teaches wherein the distribution channel is formed within a tissue-contacting surface of each of the one or more tubular members (Fig 4B, distribution channel is formed within tissue contacting surface of distal tip of electrode assembly).
Regarding claim 16, Bordoley teaches an electrically conductive terminal mounted on the electrode body and exposed to the electrically conductive path (Fig 4B, wire 410 connected to conductive path of tubular member to convey signals from scalp to downstream EEG processing as disclosed in [0144]).
Regarding claim 17, Bordoley teaches A method for measuring EEG signals comprising: placing an electrode assembly on a head of a patient (Fig 2-3 electrode assemblies 302 on patient’s head), the electrode assembly comprising an electrode body and one or more tubular members having a distal tip extending from the electrode body, each tubular member comprising a lumen and a distribution channel, the lumen having a distal opening in the distal tip (Fig 4B tubular member has delivery channel 418 below seal 406; examiner notes portion of channel 418 within the tubular member is interpreted as the lumen and the portion of channel 418 connecting to the exterior is interpreted as the distribution channel); and delivering a conductive fluid or gel from a reservoir in the electrode assembly through the lumen and to the distal opening of each tubular member, and through the distal opening and the distribution channel to a skin surface of the patient to form an electrically conductive path ([0145]), wherein the conductive fluid or gel enters the distribution channel directly from the lumen (Fig 4B, gel 420 goes from delivery channel 418 directly to distribution channels to the exterior of a patient’s scalp).
Regarding claim 26, Bordoley teaches wherein the reservoir comprises a sealed dispensing container, and delivering the conductive fluid or gel comprises manually applying external pressure to the sealed dispensing container (Fig 4B conductive gel sealed behind seal 406 and is manually ruptured by depressing plunger 306).
Regarding claim 27 and 29, Bordoley teaches wherein the measured EEG signals are used to monitor a status of the patient ([0132]); monitoring the EEG signals using the electrode assembly ([0132] electrode assemblies gather signals that are monitored).
Regarding claim 30, Bordoley teaches wherein the distribution channel is formed within a tissue-contacting surface of each of the one or more tubular members (Fig 4B, distribution channel is formed within tissue contacting surface of distal tip of electrode assembly).
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) 12 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley (U.S. PGPub No. 2012/0143020).
Regarding claims 12 and 31, Bordoley teaches the device of claim 2 and the method of claim 17 as stated above.
Bordoley discloses substantially all the limitations of the claim(s) except an explicit disclosure of a crescent shaped tubular member.
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 claimed invention to have modified the tubular member of Bordoley to be crescent shaped since applicant has not disclosed that claimed shape solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any other shape. Examiner notes applicant’s specification disclosing that the claimed prongs may have any shape including arcuate, circular, cylindrical, and crescent-shaped peripheries without highlighting any criticality to the claimed crescent shape ([0026] [0094] of applicant’s PGPub 2025/0213165 ). Furthermore, it has been held that the configuration of the claimed structure was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 4, 14, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley (U.S. PGPub No. 2012/0143020) in view of Dickson (U.S. Patent No. 4,458,687)
Regarding claim 4, Bordoley teaches the device of claim 2 as stated above.
Bordoley fails to teach wherein the electrode body comprises three tubular members.
In related prior art, Dickson teaches a similar device wherein the electrode body comprises three tubular members (Figs 2-3, tubular members 18, 20, and 22 extending from device each has central bore 18a, 20a, 22a for delivering conductive gel). 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 electrode body of Bordoley in view of Dickson to incorporate the three tubular members to arrive at claim 4. Doing so would have been a simple substitution of one well-known electrode configuration (Bordoely, with one tubular member) for another well-known electrode configuration (Dickson with three tubular members for providing gel and contacting skin) to yield the predictable result of providing a conductive skin-electrode interface for collecting physiological signals.
Regarding claim 14, Bordoley teaches the device of claim 2 as stated above.
Bordoley fails to teach wherein the electrode body comprises a horizontal passageway directly connected to the lumen of the one or more tubular members.
In related prior art, Dickson teaches wherein the electrode body comprises a horizontal passageway directly connected to the lumen of the one or more tubular members (Fig 5, has horizontal passageway 68 directly connected with lumen 26a which is directly connected with distribution channel 22a at a distal tip). 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 passageways of Bordoley in view of Dickson to incorporate the horizontal passageway directly connected to the lumen to arrive at claim 14. Doing so 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 claimed invention since applicant has not disclosed that horizontal passage solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well without a horizontal passageway as either configuration yields the same result of providing a conductive gel from an internal reservoir to the patient’s skin to increase conductivity.
Regarding claim 25, Bordoley teaches the method of claim 17 as stated above.
Bordoley fails to teach wherein the electrode body comprises a horizontal passageway directly connected to the lumen of the one or more tubular members, and the conductive fluid or gel is delivered from the reservoir to the lumen via the horizontal passageway.
In related prior art, Dickson teaches wherein the electrode body comprises a horizontal passageway directly connected to the lumen of the one or more tubular members, and the conductive fluid or gel is delivered from the reservoir to the lumen via the horizontal passageway (Fig 5, has horizontal passageway 68 directly connected with lumen 26a which is directly connected with distribution channel 22a at a distal tip). 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 passageways of Bordoley in view of Dickson to incorporate the horizontal passageway directly connected to the lumen to arrive at claim 25. Doing so 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 claimed invention since applicant has not disclosed that horizontal passage solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well without a horizontal passageway as either configuration yields the same result of providing a conductive gel from an internal reservoir to the patient’s skin to increase conductivity.
Claim(s) 6-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley (U.S. PGPub No. 2012/0143020) in view of Rood (U.S. Patent No. 8,201,330).
Regarding claims 6-11 and 13, Bordoley teaches the device of claims 5 and 12 as stated above.
Bordoley fails to teach wherein the tissue-contacting surface comprises a skin preparation surface; wherein the skin preparation surface comprises a plurality of skin-roughening features; wherein the plurality of skin-roughening features comprises ridges; wherein the skin preparation surface comprises an abrasive material; wherein the abrasive material comprises abrasive particles.
In related prior art, Rood teaches a similar device comprising a skin preparation surface (Fig 4 penetrators 16); wherein the skin preparation surface comprises a plurality of skin-roughening features (Fig 4 penetrators 16); wherein the plurality of skin-roughening features comprises ridges (Fig 4 penetrators 16 are reasonably interpreted as ridges; see also Cl 3 lines 64-67); wherein the skin preparation surface comprises an abrasive material (Col 3 line 64 – Col 4 line27; ridges enable abrasiveness to remove or displace hair, dead skin cells and detritus); wherein the abrasive material comprises abrasive particles (penetrators are abrasive as stated above, thus necessarily have abrasive particles). 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 device of Bordoley in view of Rood to incorporate the skin preparation surfaces of Rood to arrive at claims 6-11 and 13. Doing so would advantageously enable the device to prepare the skin surface by displacing hair, dead skin cells, and detritus to increase conductivity of the skin-electrode interface as is known in the art.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Levendowski (U.S. PGPub No. 2002/0029005).
Regarding claim 15, Bordoley teaches the device of claim 2 as stated above.
Bordoley fails to teach wherein the one or more tubular members at least partially comprise a polymer material.
In related prior art Levendowski teaches wherein the at least one tubular member comprises a conductive polymer (Fig 15-16 [0071] fingers 164 are formed of conductive silicone). 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 tubular member of Bordoley in view of Levendowski to incorporate a tubular member comprising a polymer to arrive at claim 15. Doing so would advantageously incorporate a conductive and flexible material that is capable of deforming to the curvature of a patient’s scalp to maximize comfort while maintaining functionality.
Claim(s) 18-19, 23-24, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Oakley (U.S. PGPub No. 2016/0354005).
Regarding claim 18-19, 23-24, and 32, Bordoley teaches the method of claim 17 as stated above.
Bordoley fails to teach abrading the skin surface by rotating the electrode body; abrading is accomplished by a skin preparation surface of the one or more tubular members; wherein the skin preparation surface comprises an abrasive material; wherein the abrasive material comprises abrasive particles; wherein the tissue-contacting surface comprises a skin preparation surface.
In related prior art, Oakley teaches a similar method comprising abrading the skin surface by rotating the electrode body ([0119] electrode 30 is rotatable to abrade scalp); abrading is accomplished by a skin preparation surface of the one or more tubular members (Fig 4-5 [0119] tubular member of electrode performs the abrading); wherein the skin preparation surface comprises an abrasive material; wherein the abrasive material comprises abrasive particles ([0119] discloses electrode abrading skin, thus material must be abrasive with abrasive particles); wherein the tissue-contacting surface comprises a skin preparation surface (Fig 4-5 [0119] discloses tissue contacting surface of electrode abrading skin). 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 Bordoley in view of Oakley to incorporate the step of abrading the skin surface by rotating the tubular member of the electrode body to arrive at claims 18-19, 23-24, and 32. Doing so would advantageously remove dead skin from the scalp to assist in achieving better electrical contact and conductivity ([0119]).
Claim(s) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Oakley and Rood.
Regarding claims 20-22, Bordoley/Oakley teaches the method of claims 18-19 as stated above.
Bordoley fails to teach wherein the skin preparation surface comprises a plurality of skin-roughening features; wherein the plurality of skin-roughening features comprises ridges.
In related prior art, Rood teaches a similar device comprising a skin preparation surface (Fig 4 penetrators 16); wherein the skin preparation surface comprises a plurality of skin-roughening features (Fig 4 penetrators 16); wherein the plurality of skin-roughening features comprises ridges (Fig 4 penetrators 16 are reasonably interpreted as ridges; see also Col 3 lines 64-67). 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 device of Bordoley in view of Oakley and Rood to incorporate the skin preparation ridges of Rood to arrive at claims 20-22. Doing so would advantageously enable the device to prepare the skin surface by displacing hair, dead skin cells, and detritus to increase conductivity of the skin-electrode interface as is known in the art.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Housley (U.S. PGPub No. 2013/0154827)
Regarding claim 28, Bordoley teaches the method of claim 17 as stated above
Bordoley fails to teach tracking patient movement to determine if the patient is experiencing a convulsive seizure.
In related prior art, Housley teaches tracking patient movement to determine if the patient is experiencing a convulsive seizure ([0023] accelerometer module measures patient movement to detect convulsive seizures). 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 method of Bordoley in view of Housley to incorporate the convulsive seizure detection module with accelerometer module to track patient movement to determine occurrence of a convulsive seizure to arrive at claim 28. Doing so would advantageously enable the system and method to detect potentially life threatening seizures ([0023]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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