DETAILED ACTION
Applicant' s arguments, filed 12/03/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/13/2022, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-9 and 11-21 are the current claims hereby under examination.
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 .
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “said electrode is comprised of passages” but it is unclear if these passages are the same as, related to, or different from “a plurality of through passages” of claim 1 lines 4-5. For the purposes of this examination, the limitations will be interpreted as referring to the same passages.
Claim 21 recites “the adhesive being a sensitive skin grade adhesive” but it is unclear if this limitation is meant to convey particular material properties or compositions to the adhesive. For the purposes of this examination, any skin adhesive may be considered “a sensitive skin grade adhesive”.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1, 3-9, 15, and 17-18 are rejected under 35 U.S.C. 103 as being obvious over Delic US Patent Application Publication Number US 2007/0238945 A1 hereinafter Delic, in view of Montecalvo US Patent Number US 5205297 A hereinafter Montecalvo in view of Kantner US Patent Number US 5730126 A hereinafter Kantner, further in view of Henson US Patent Application Publication Number US 2015/0011857 A1 hereinafter Henson
Regarding claim 1, Delic discloses an electrode system for sensitive skin (Abstract), comprising:
(a) a sensitive skin electrode (Paragraphs 0093: the electrodes), comprising:
(i) a housing with a wall defining a recess formed in said housing (Paragraphs 0112-0113; Fig. 11A reference 1114: the housing);
(ii) an electrode in said recess (Paragraph 0113; Fig. 11A reference 1102: the electrode plate);
(iii) a conductive gel in said recess and in contact with said electrode (Paragraph 0113: the contact pad may be wetted with a conductive liquid such as saline; paragraph 0103: an alternative conductive liquid is a conductive gel; Fig. 11A reference 1112);
(iv) an electrical conductor having a first end and a second end (Paragraph 0112: the wire; Fig. 11A reference 1108)
(b) a template structure (Fig. 7A reference 700; Paragraph 0091: EEG sensor headset), comprising:
(i) a plurality of integrally connected template portions (Fig. 7A references 706, 708, 710, and 712; Paragraph 0092: the overlapping webbing sections);
(ii) one or more electrode sites formed on the plurality of template portions configured to receive the sensitive skin electrode, (Fig. 7A references 714 and the surrounding mounts; Paragraph 0093: the electrode mounts;).
Delic fails to further disclose the system comprising: (ii) the electrode comprising a plurality of through passages; (iii) wherein the conductive gel penetrates into the plurality of through passages and reduces lateral movement of the electrode in the recess; (iv) an electrical conductor having a first end and a second end, said first end of said electrical conductor being connected to said electrode in said recess; (v) a connector connected to said second end of said electrical conductor; and wherein the one or more electrode sites are configured to contain a conductive gel prior to receiving the sensitive skin electrode.
Montecalvo teaches a medical electrode (Abstract). Thus, Montecalvo is reasonably pertinent to the problem at hand.
Montecalvo teaches an electrode comprising: (i) a housing with a wall defining a recess formed in said housing (Fig. 6 references 24 and 12; Col 4 lines 15-26: the protective foam layer and concentric ring); (ii) an electrode in said recess (Fig. 6 reference 14; Col 3 line 64 – Col 4 line 15: the electrically conductive backing layer); (iii) a conductive gel in said recess and in contact with said electrode (Fig. 6 reference 22; Col 4 lines 27-41: the electrically conductive matrix is a non-fluid gel); (iv) an electrical conductor having a first end and a second end, said first end of said electrical conductor being connected to said electrode in said recess (Fig. 7 references 32 and 16; Col 7 lines 1-18: insulated wire which connects to the electrode); (v) a connector connected to said second end of said electrical conductor (Fig. 7 references 30a, 32a, 34a-b, and 38; Col 6 line 63 – Col 7 line 47: various types of connectors for attaching the electrode);
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the system of Delic to utilize the electrode of Montecalvo because Delic teaches that various configurations of electrodes can be mounted to the electrode headsets (Paragraph 0112) and utilizing the electrodes of Montecalvo may simply the system of Delic by removing the additional circuitry associated with each electrode described in Delic. Furthermore, implementing the electrode including a connection on both ends of the wire would be obvious to allow the system to readily connect to various types of EEG monitoring equipment.
Delic in view of Montecalvo fails to further disclose the system comprising: (ii) the electrode comprising a plurality of through passages; (iii) wherein the conductive gel penetrates into the plurality of through passages and reduces lateral movement of the electrode in the recess; and wherein the one or more electrode sites are configured to contain a conductive gel prior to receiving the sensitive skin electrode.
Kantner teaches a stud/eyelet for a biomedical electrode is disclosed. The stud/eyelet has at least one hole in the base to reduce manufacturing cost, provide increased surface contact with ionically conductive media, and to increase anchorage for the ionically conductive media (Abstract). Thus, Kantner is reasonably pertinent to the problem at hand.
Kantner teaches a biomedical electrode with holes, or passages, which allow conductive media to penetrate and increase the contact surface area between the electrode and the conductive media (Col 1 line 66 – Col 2 line 8). The increased contact surface area provides better electrical contact and improved anchoring of the electrode to the conductive media (Col 3 lines 61-65)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct the electrode of Montecalvo as applied in the system of Delic to include holes, or passages, as taught by Kantner because Kantner teaches that the holes reduce material cost and increase the contact surface area between the electrode and the conductive media which may result in improved electrical performance and anchorage (Kantner: Col 1 line 66 – Col 2 line 8).
Delic in view of Montecalvo further in view of Kantner fails to further disclose the system comprising: the one or more electrode sites are configured to contain the conductive gel prior to receiving the sensitive skin electrode.
Henson teaches a shielded sensor headset including a plurality of electrodes. A sensor headset can include electrodes, traces, and connection terminals printed on a first side of a flexible insulating substrate; and a shield plane printed on a second side of the flexible insulating substrate, the shield plane providing protection against interference. In some embodiments a sensor headset can include a first and a second assembly each having a plurality of electrodes, the first and second assemblies being configured to mate such that the electrodes comply with the 10-20 standard for EEG electrode placement. In some embodiments a sensor headset can include a dual-layer foam reservoir disposed above individual electrodes. An inner layer of the dual-layer foam reservoir can be in contact with an electrode, include a conductive gel, and form a cavity for receiving additional gel through a perforation in the electrode (Abstract). Thus, Henson falls within the same field of endeavor as Applicant’s invention.
Henson teaches a plurality of dual-layer foam reservoirs which are coupled to electrodes and wherein the reservoirs include a conductive gel (Paragraph 0057; Figs. 17-18 references 970, 910, 912, and 916). The reservoirs ensure the electrodes have good contact with the scalp when applying the headset (Paragraphs 0037 and 0091). The reservoirs may be coupled to the headset by using an adhesive on the outer wall area while the inner gel-filled portion makes contact with the electrode (Paragraphs 0096-0097). Henson at least suggests the reservoirs are gel-filled prior to attachment of an electrode in paragraphs 0094-0095 and 0097 where Henson discusses how the outer layer keeps the gel-soaked inner layer contained and further discuses a punch-through area that may allow a user to apply additional conductive gel to the electrode. These recitations are drawn towards the structure of the reservoir itself and appear to indicate that the reservoir comes pre-gelled prior to attachment to an electrode.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the dual-foam reservoirs of Henson at the electrode sites of Delic because Henson teaches that these structures help to ensure good contact between the electrode and the user’s scalp even in the presence of hair (Henson: paragraphs 0037 and 0091). Additionally, the electrodes of Montecalvo as modified by Kantner and implemented into the system of Delic are well suited for attaching to the reservoirs as the conductive medium of Montecalvo, the conductive gel, can integrate with the gel-soaked inner layer of the dual foam reservoir of Henson.
Regarding claim 3, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising one or more areas of the plurality of template portions comprising an adhesive coating.
Henson teaches the system further comprising one or more areas of the plurality of template portions comprising an adhesive coating (Paragraph 0043: a patient side adhesive).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the patient side adhesive taught by Henson into the system of Modified Delic because the patient side adhesive ensures that a desired contact pressure for the electrodes is maintained (Henson: paragraph 0043).
Regarding claim 4, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic further teaches the system further comprising the template structure comprising a plurality of electrode sites, the plurality of electrode sites corresponding to a 10-20 configuration (Paragraphs 0096: the plurality of electrode sites may correspond to the 10-20 scheme of electrode placement).
Regarding claim 5, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 4. Modified Delic fails to further teach the system further comprising the plurality of electrode sites loaded with the conductive gel prior to attachment of the sensitive skin electrode.
Henson teaches the plurality of electrode sites loaded with the conductive gel prior to attachment of the sensitive skin electrode (Paragraphs 0094-0095 and 0097 The removable adhesive cover prevents leakage of previously infused gel in the inner layer. The recitation of preventing gel leaking at least suggests that the reservoirs are filled prior to attaching the headset to a patient and/or electrodes since, in the system of modified Delic, these reservoirs are located at each electrode site prior to placement of the electrode.).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the loading of conductive gel into the electrode sites prior to attachment of the sensitive skin electrodes as taught by Henson into the system of modified Delic because pre-loading the sites before placing the electrodes would improve the usability of the system since the electrode sites may be difficult to load with conductive gel after placement of the electrodes and pre-filling each site ensures that the desired quantity of conductive gel is present to ensure strong signal readings before attaching the electrodes.
Regarding claim 6, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic further teaches the system further comprising the template structure being formed from a foam (Paragraph 0092: the headset if constructed of a plurality of sections each constructed from a webbing. The webbing is a stretchable material that includes voids for airflow such as neoprene. Neoprene may be produced as a foam material and is thus sufficient to at least suggest the headset being constructed of foam).
Regarding claim 7, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic further teaches the system further comprising an opening being formed in said wall for said electrical conductor to pass therethrough (Fig. 11A: the hole in the housing 1114 to allow the wire 1108 into the housing).
Regarding claim 8, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising said electrode system comprising:(a) an adhesive on said wall; and (b) a release paper on said adhesive.
Montecalvo teaches a system further comprising said electrode system comprising:(a) an adhesive on said wall (Col 4 lines 15-26: the ring of concentric foam, or wall, includes a pressure sensitive adhesive applied to its exposed surface); and (b) a release paper on said adhesive (Col 4 lines 42-57: a removable slip sheet or liner covers the pressure sensitive adhesive).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the adhesive on the wall of the electrode and the removable adhesive cover of Montecalvo into the system of modified Delic because such an adhesive would aid in the attachment of the electrodes of modified Delic to the headset and/or the electrode sites and the removable cover would protect the adhesive until the electrodes are ready to use and also serve to prevent leakage of the conductive liquid within the electrode housing.
Regarding claims 9 and 18, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising said housing is made of foamed plastic; and further comprising said housing being comprised of polyethylene foam.
Montecalvo teaches the system further comprising said housing is made of foamed plastic such as polyethylene (Col 4 lines 15-26: the concentric ring and protective foam layer may be made of plastic foam such as polyethylene).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the housing material of modified Delic to be a foamed plastic because it is a simple substitution of one known element for another with no surprising technical effect. In particular, the exact materials that comprise the housing do not appear to alter the function of the electrode or electrode system.
Regarding claim 15, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising said electrode being comprised of passages to allow the conductive gel to adhere and reduce lateral movement.
Kantner teaches a biomedical electrode with holes which allow conductive media to penetrate and increase the contact surface area between the electrode and the conductive media (Col 1 line 66 – Col 2 line 8). The increased contact surface area provides better electrical contact and improved anchoring of the electrode to the conductive media (Col 3 lines 61-65)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct the electrode of modified Delic to include holes, or passages, as taught by Kantner because Kantner teaches that the holes reduce material cost and increase the contact surface area between the electrode and the conductive media which may result in improved electrical performance and anchorage (Kantner: Col 1 line 66 – Col 2 line 8).
Regarding claim 17, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising a sleeve, and said sleeve is operable to connect said electrical conductor to said electrode.
Montecalvo teaches the system further comprising a sleeve, and said sleeve is operable to connect said electrical conductor to said electrode (Fig. 7: the larger part between 32 and 32b; Col 7 lines 28-33: the sleeve appears to be part of the male style pin connector)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the sleeve as taught by Montecalvo into the system of modified Delic because the larger diameter portion of the wire which the connector is attached to would improve the durability of the connector portion which may receive the highest degree of wear and tear during use.
Claims 2, 19, and 21 are rejected under 35 U.S.C. 103 as being obvious over Delic US Patent Application Publication Number US 2007/0238945 A1 hereinafter Delic, in view of Montecalvo US Patent Number US 5205297 A hereinafter Montecalvo in view of Kantner US Patent Number US 5730126 A hereinafter Kantner, further in view of Henson US Patent Application Publication Number US 2015/0011857 A1 hereinafter Henson as applied to claim 1 above and further in view of Lovejoy US Patent Number US 6453186 B1 hereinafter Lovejoy.
Regarding claim 2, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising the one or more electrode sites formed by a release paper adhered to one side of the template structure opposing a sensitive skin electrode receiving side of the template structure.
Henson teaches the system further comprising the one or more electrode sites formed by a removable cover adhered to one side of the template structure opposing the sensitive skin electrode receiving side of the template structure (Fig 18 reference 916; Paragraph 0097: the removable adhesive cover).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the removable adhesive cover of Henson into the system of modified Delic because such a cover would prevent the leakage of conductive gel prior to use of the headset as taught by Henson (Henson: paragraph 0097).
Delic in view of Montecalvo in view of Kantner further in view of Henson fails to further disclose the removable cover being a release paper.
Lovejoy teaches an electrode patch for attachment to a neonatal or infant patient (Abstract). Thus, Lovejoy is reasonably pertinent to the problem at hand.
Lovejoy teaches that a removable cover may be a wax-covered paper which serves to protect a conductive gel until it is ready for use (Col 6 line 59 - Col 7 line 13).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the wax covered paper of Lovejoy into the system of modified Delic to serve as the removable adhesive cover because Lovejoy teaches that such a material is suitable for creating a removable liner that contains conductive gel (Col 6 line 59 – Col 7 line 13)
Regarding claim 19, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising said conductive gel being a neonatal conductive gel.
Lovejoy teaches a conductive gel being a neonatal conductive gel (Col 6 lines 24-37: the conductive gel is suitable for attachment to a neonatal or infant skin).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the neonatal gel taught by Lovejoy as the conductive gel of modified Delic because the neonatal gel may provide the same or similar conductive properties but be less irritating than standard conductive gel and would thus improve the patient’s comfort.
Regarding claim 21, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising the template structure lined with adhesive, the adhesive being a sensitive skin grade adhesive.
Henson teaches the template structure lined with adhesive (Paragraph 0043: the template structure may be at least partially coated with adhesive for securing the template to the user)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the patient side adhesive taught by Henson into the system of Modified Delic because the patient side adhesive ensures that a desired contact pressure for the electrodes is maintained (Henson: paragraph 0043).
Delic in view of Montecalvo in view of Kantner further in view of Henson fails to further teach the adhesive being a sensitive skin grade adhesive.
Lovejoy teaches the template structure lined with adhesive, the adhesive being designed for sensitive skin (Col 6 lines 38-51: the skin adhesive is suitable for attachment to a neonatal or infant skin).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the neonatal adhesive taught by Lovejoy as the adhesive of modified Delic because the neonatal adhesive may provide the same or similar adhesive properties but be less irritating than standard adhesive and would thus improve the patient’s comfort.
Claim 11 is rejected under 35 U.S.C. 103 as being obvious over Delic US Patent Application Publication Number US 2007/0238945 A1 hereinafter Delic, in view of Montecalvo US Patent Number US 5205297 A hereinafter Montecalvo in view of Kantner US Patent Number US 5730126 A hereinafter Kantner, further in view of Henson US Patent Application Publication Number US 2015/0011857 A1 hereinafter Henson as applied to claim 1 above and further in view of Larke US Patent Number US 4109648 A hereinafter Larke.
Regarding claim 11, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising said electrical conductor being comprised of carbon fibers.
Larke teaches a skin electrode assembly comprises a body of hydrophilic gel, and an electrochemically inert member rendered conductive by the inclusion of carbon therein, the gel body and member being directly electrically connected. The member is suitably wholly of carbon such as graphite, and the gel body can be self-supporting or located in a dished plastics housing through which the member passes. The housing can be a fitting lens for ophthalmic measurements (Abstract). Thus, Larke is reasonably pertinent to the problem at hand.
Larke teaches an electrode which is connected to a conductive member comprised of carbon fibers (Col 2 lines 3-17).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct the wire, or electrical conductor, of modified Delic using carbon fibers as taught by Larke because such a change is a simple substitution of one known element for another with no surprising technical effect. In particular, the electrical conductor performs the same function and the change in material composition does not produce a surprising technical effect.
Claims 12-14 and 16 are rejected under 35 U.S.C. 103 as being obvious over Delic US Patent Application Publication Number US 2007/0238945 A1 hereinafter Delic, in view of Montecalvo US Patent Number US 5205297 A hereinafter Montecalvo in view of Kantner US Patent Number US 5730126 A hereinafter Kantner, further in view of Henson US Patent Application Publication Number US 2015/0011857 A1 hereinafter Henson as applied to claim 1 above and further in view of Lane US Patent Application Publication Number US 2005/0261565 A1 hereinafter Lane.
Regarding claims 12-14 and 16, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system, further comprising said electrode being comprised of silicone rubber coated with conductive material. The electrode system further comprising said electrode being comprised of silicone rubber filled with conducting fibers. The electrode system further comprising said electrode being comprised of acrylonitrile butadiene styrene with an electrically conductive coating. Or the electrode system wherein said electrode is comprised of acrylonitrile butadiene styrene with a conductive coating made of a mixture of silver and silver-chloride.
Montecalvo teaches that the electrode is made of silicone and filled with conductive particles (Col 4 lines 1-14: the conductive backing layer may be silicone rendered conductive by the addition of carbon particles).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the electrode composition of the system of modified Delic to silicone with implanted conductive elements because such a modification is a simple substitution of one known element for another with no surprising technical effect.
Delic in view of Montecalvo in view of Kantner further in view of Henson fails to further teach the system, further comprising said electrode being comprised of silicone rubber coated with conductive material. The electrode system further comprising said electrode being comprised of acrylonitrile butadiene styrene with an electrically conductive coating. Or the electrode system wherein said electrode is comprised of acrylonitrile butadiene styrene with a conductive coating made of a mixture of silver and silver-chloride.
Lane teaches sensors or eyelets are provided for use in medical electrodes. Also provided are sensors for use in medical electrodes where the sensors are coated with a with a silver/silver chloride coating in a discrete area. Silver/silver chloride medical electrodes are provided that have a sensor or eyelet made of conductive plastic which is discretely coated with silver/silver chloride only in the area in which the sensor makes direct contact with the electrolyte gel in the conductive pathway (Abstract). Thus Lane is reasonably pertinent to the problem at hand.
Lane teaches electrodes which may be made of acrylonitrile butadiene styrene which may be carbon filled and have a silver and silver chloride coating (Paragraph 0029). The sensor or eyelet can further be comprised of a plastic and coated with silver/silver chloride or be a carbon-filled thermoplastic resin with carbon fibers embedded therein (paragraph 0033).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the electrode of modified Delic to be filled with carbon fiber, comprised of acrylonitrile butadiene styrene, and/or have a silver/silver chloride coating as taught by Lane because such modifications are simple substitutions of one known element for another with no surprising technical effects. In particular, it is asserted that the particular composition and/or coatings of the electrode is subject to routine optimization and experimentation to produce an electrode at the desired cost level, required level or durability, and required level of electrical conductance. The particular composition of the electrode serves to optimize any of these factors but does not produce any surprising technical effect.
Claim 20 is rejected under 35 U.S.C. 103 as being obvious over Delic US Patent Application Publication Number US 2007/0238945 A1 hereinafter Delic, in view of Montecalvo US Patent Number US 5205297 A hereinafter Montecalvo in view of Kantner US Patent Number US 5730126 A hereinafter Kantner, further in view of Henson US Patent Application Publication Number US 2015/0011857 A1 hereinafter Henson as applied to claim 1 above and further in view of Flores US Patent Application Publication Number US 2009/0099469 A1 hereinafter Flores.
Regarding claim 20, Delic in view of Montecalvo in view of Kantner further in view of Henson teaches the electrode system of claim 1. Modified Delic fails to further teach the system further comprising said housing carrying an electrode position designation.
Flores teaches an ECG/EKG patient telemetry monitoring system is disclosed, the system configured for monitoring the cardiac activity of a patient. The wireless ECG patient telemetry monitoring system includes a plurality of self-contained wireless electrodes adapted to adhesively secure to the skin of the torso of the patient and to measure electric potential on the skin as related to electrical activity of the heart. ECG signals from the electrodes are wirelessly communicated to a central monitor, which provides graphical ECG voltage potential versus time plots for a technician, nurse, or physician (Abstract). Thus, Flores is reasonably pertinent to the problem at hand.
Flores teaches electrodes wherein the housings comprise placement position indicators (Paragraphs 0026-0027; Claim 14; Fig. 1 ).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to label the electrodes of modified Delic with placement position indicators as taught by Flores because such indicators may help ensure that each electrode is placed properly and that the signals recorded from each electrode are properly labeled for their corresponding brain region.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not persuasive.
In particular, Applicant’s arguments directed towards the modification of the electrodes of Delic as previously presented have been rendered moot as the newly presented grounds of rejection replace the electrodes of Delic entirely with the electrodes of Montecalvo as modified by Kantner.
Applicant further argues that Kantner does not teach the claimed through passages and that the base holes described in Kantner achieves a completely different desired result. These arguments are not found to be persuasive because the “through passages” of the claims are not described in a manner which excludes the holes of Kantner. The particular structure of Applicant’s electrode is not specifically described and thus the holes of Kantner provide sufficient structure to anticipate the present claim language. Additionally, Kantner teaches that he through holes provide better electrical contact and anchoring to the gel (Kantner Col 3 lines 61-65) which is the same intended effect as Applicant’s passages. Applicant’s arguments are not commensurate in scope with the present claim language.
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.
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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791