DETAILED ACTION
This action is pursuant to the claims filed on 04/30/2025. Claims 2-32 are pending. A first action on the merits of claims 2-32 is as follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/17/2025 and 04/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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 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.
The factual inquiries 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.
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]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 19/213,887 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims either anticipate or make obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794