DETAILED ACTION
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Response to Amendment
The amendment filed September 29th, 2025 has been entered. Claims 1-15 and 19-20 remain pending in the application. Claims 16-18 have been cancelled. Applicant’s amendments to the claims have overcome some of the objections and rejections previously set forth in the Final Office Action mailed May 9th, 2025.
Response to Arguments
Applicant’s arguments regarding the rejection under 35 U.S.C. 101 have been considered and are persuasive, the rejection has been withdrawn.
Applicant’s arguments with respect to claims 1-15 and 19-20, see Pages 8-15, have been considered but are only found to be partially persuasive. Upon further consideration of applicant’s arguments the examiner has decided to reopen prosecution. The amendments filed 09/29/2025 have been entered.
Regarding applicant’s arguments that Devlin would not benefit from indicia to aid in placement as taught by Brodnick. However the examiner respectfully disagrees as the motivation for including the indicia is to allow for the operator to attach the electrodes to the patient at the correct spots (Brodnick, Col. 4, lines 5-6). The examiner has therefore shown a motivation for combining the references from the perspective of one having ordinary skill in the art. Further since both Devlin and Brodnick are references relating to electrodes and the placement of electrodes on the patient’s body.
Further the applicant argues that Devlin only discloses the use of 3 electrodes, however the examiner respectfully disagrees. As can be seen in Figure 15(a) there is four electrodes. Further while Brodnick may disclose the use of separate electrodes, it would be obvious to one of ordinary skill in the art to provide indicia on the electrodes as disclosed by Devlin whether the electrodes are combined or separate to ensure the proper placement of the electrodes. Therefore there is a motivation to combine the teachings of Devlin and Brodnick. While Brodnick may disclose placing the electrodes in relation to one another, the indicia works all in the same for placing the electrodes in the correct position and direction.
Regarding applicant’s arguments about the use of the Bibian reference, the examiner finds these persuasive. Therefore the rejection is withdrawn. However upon further consideration, a new rejection is made over Devlin in view of Brodnick, Machon and Loutis. See new grounds for rejection below.
Regarding applicant’s arguments about Su not disclosing “alignment indicators pointing in substantially the same direction” the examiner respectfully disagrees. The arrows on the top of the electrode are pointing in “substantially” the same direction. It would be obvious to incorporate wherein “all” the alignment indicators point in substantially the same direction in order to ensure that the sensor is placed in the desired orientation and position (Su, Paragraph [0034]).
Lastly, the applicant has failed to address the 112(b) rejections regarding what is meant by “the label is separate and attached to the insulating region and if the “label” is the same as the “alignment indicators”. See rejections below.
Claim Rejections - 35 USC § 112
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 1-15, and 19-20 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.
Claims 1, 9 and 13 recite “the label being separate and attached to the insulating region”. It is unclear as to what is meant by “the label being separate” means. The specification discloses on Page 4, lines 6-15, “the label may be printed directly onto the outer surface of the insulating region or adhesive collar material or may be printed onto a separate sheet and applied to the outer surface of the insulating region … the label may also be stamped, etched, marked, engraved, burned, or affixed to the outer surface of the insulating regio or adhesive collar material”. For purposes of examination the examiner interprets “the label being separate” as meaning the label is created separately from the insulating region and later attached to the insulating region via a method like printing or a similar process.
Claims 1 and 13 recite “each electrode further comprising a label”. Claim 1 further recites “reference electrode each having on their fronts one or more alignment indicators” and claim 13 further recites “the label further being an unregistered label having on its surface one or more alignment indicators”. It is unclear whether the label and the alignment indicators are meant to be the same thing or different things? Is the label made up of alignment indicators? The specification describes “the electrode label has one or more alignment indicators”. For purposes of examination the examiner interprets the label and the alignment indicators to be the same thing. Examiner suggests modifying the claim language to recite wherein the label is further comprised of alignment indicators.
Claims 2-8, 10-12, 14-15, and 19-20 are rejected by virtue of dependency on claims 1, 9, and 13.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Devlin et al. (U.S. Pat. No. 6,394,953) herein referred to as “Devlin” in view of Brodnick et al. (U.S. Pat. No. 6,748,256) herein referred to as “Brodnick” further in view of Machon et al. (U.S. PGPub. No. 2014/0257073) herein referred to as Machon, further in view of Loutis et al. (U.S. Pat. No. 6415170) herein referred to as “Loutis”.
Regarding claim 1, Devlin discloses a set of electroencephalographic monitoring electrodes (array of electrodes fits easily over the temple and forehead areas where EEG signals can be acquired, Col. 3, lines 26-27) comprising:
at least four electrodes, including a first electrode for the patient's right temple, a second electrode for the patient's left temple, a reference electrode, and a ground electrode (an electrode array comprising only four electrodes for monitoring electroencephalographic signals, positioning a first electrode on the forehead, a second electrode on a first temple, a third electrode on the forehead and a fourth electrode on a second temple, claim 10, the array 10 is mounted over the forehead with its reference electrode 12b over the center of the forehead, the ground electrode 12a is placed over the forehead as well, Col. 5, lines 62-65, Figures 13(a) and 13(b)),
each electrode having a front, a back, and bottom, top, left, and right sides (each electrode has a front, a back, and bottom, top, left, and right sides, Figures 15(a) and 15(b)),
each electrode back, each electrode further comprising an insulating region (each electrode 12 is surrounded by a foam layer 43, Col. 5, lines 36-37), and an adhesive layer (adhesive backed foam layer, Col. 5, lines 36-37), the insulating region having a conductive region surrounded by the insulating region (conductive region 12 Is surrounded by the insulating region 43, Col. 5, lines 36-37) (each electrode 12 is surrounded by an adhesive backed foam layer 43, Col. 5, lines 36-37).
However Devlin does not explicitly disclose wherein each electrode further comprising a label, the label being separate and attached to the insulating region, nor wherein each electrode front being visually distinct from the fronts of the other electrodes; and the right temple electrode, left temple electrode, and reference electrode each having on their fronts one or more alignment indicators that visually aid in the proper placement of each of those electrodes by visually indicating electrode placement position and direction.
Brodnick discloses wherein each electrode comprises a label, the label being separate and attached to the insulating region (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5, wherein the indicium is printed on the back of the electrodes (i.e., seen as the insulating region of the electrode), Col. 4, lines 21-24, ) the label being visually distinct from the fronts of the other electrodes (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5); and the electrodes each having on their fronts one or more alignment indicators that visually aid in the proper placement of each of those electrodes by visually indicating electrode placement position and direction (the indicium assists the operator in attaching the electrodes to the patient at the correct spots for the electrodes, Col. 4, lines 4-6, additionally the electrodes may include a “pointer” or “reference” to help provide orientation for the electrode, Col. 4, lines 15-16, Figure 4).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Brodnick by including wherein each electrode front being visually distinct from the fronts of the other electrodes; and the right temple electrode, left temple electrode, and reference electrode each having on their fronts one or more alignment indicators that visually aid in the proper placement of each of those electrodes by visually indicating electrode placement position and direction. The motivation to do so being to assist the operator in attaching the electrodes to the patient at the correct spots for the electrodes (Brodnick, Col. 4, lines 5-6).
Further Devlin does not explicitly disclose wherein the insulating region of at least one electrode comprising a pointed tab, the back of the tab not being adhesive or sticky, the tab having sufficient size to be grasped between a human forefinger and thumb.
Machon discloses a headset for detecting brain electrical activity (Abstract) wherein the insulating region of at least one electrode comprising a pointed tab (tab 422 comes to a point, Figures 3-5), the back of the tab not being adhesive or sticky (a user may lift tab 422 to pull the corresponding electrode of the subject’s skin while allowing the user to avoid touching any adhesive, Paragraph [0070]), the tab having sufficient size to be grasped between a human forefinger and thumb (tabs 422 allow the user to lift the tab to pull the corresponding electrode off of the subject’s skin, and serve a secondary function of aiding in the repositioning of electrode on the subject if necessary (i.e., can be grasped between a human forefinger and thumb), Paragraph [0070]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Machon by including wherein the insulating region of at least one electrode comprising a pointed tab, the back of the tab not being adhesive or sticky, the tab having sufficient size to be grasped between a human forefinger and thumb. The motivation to do so being to allow for a user to remove or reposition an electrode without coming into contact with adhesive (Machon, Paragraph [0070]).
Lastly Devlin does not explicitly disclose wherein each electrode further comprising a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise.
Loutis discloses a biomedical electrode (Abstract) wherein each electrode comprises a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise (overall shape of stud 1 can be varied, Col. 8, lines 31-34, connected stud 1 with corresponding lead, such that said lead necessarily corresponds to shape to facilitate said connection (seen as a non-standard lead), Col. 4, lines 7-18).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Loutis by including wherein each electrode further comprising a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise. The motivation to do so being to allow for a connection between the electrode and the lead for electromedical monitoring/diagnosis (Loutis, Col. 4, lines 7-17).
Regarding claim 2, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 1.
However Devlin does not explicitly disclose wherein at least one of the alignment indicators of at least one electrode comprises an arrow, triangle, finger, or other pointing indicator.
Brodnick discloses wherein at least one of the alignment indicators of at least one electrode comprises an arrow, triangle, finger, or other pointing indicator (additionally the electrodes may include a “pointer” or “reference” to help provide orientation for the electrode, Col. 4, lines 15-16, Figure 4).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein at least one of the alignment indicators of at least one electrode comprises an arrow, triangle, finger, or other pointing indicator. The motivation to do so being to assist the operator in placing the electrode in the correct orientation (Brodnick, Col. 4, lines 15-16).
Regarding claim 3, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 1.
However Devlin does not explicitly disclose wherein at least one of the alignment indicators of at least one electrode comprises text.
Brodnick discloses wherein at least one of the alignment indicators of at least one electrode comprises text (the indicium includes alphanumeric identifiers (i.e. text), Col. 4, lines 25-38, Figure 7).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein at least one of the alignment indicators of at least one electrode comprises text. The motivation to do so being to further assist the attendant in attaching the electrodes to the patient (Brodnick, Col. 4, lines 33-34).
Regarding claim 4, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 1.
However, Devlin does not explicitly disclose wherein different electrodes may be distinguished by different alignment indicators or different patterns of alignment indicators.
Brodnick discloses wherein different electrodes may be distinguished by different alignment indicators or different patterns of alignment indicators (the electrodes have a face that acquires more detail as it moves from left to right, (i.e., different alignment indicators), Col. 4, lines 13-14, Figure 4).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein different electrodes may be distinguished by different alignment indicators or different patterns of alignment indicators. The motivation to do so being to further assist the attendant in attaching the electrodes to the patient (Brodnick, Col. 4, lines 33-34).
Regarding claim 5, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 1.
Devlin further discloses wherein at least one electrode has a notch in its insulating region (notch in insulating region, see modified Figure 3 below).
PNG
media_image1.png
249
532
media_image1.png
Greyscale
Regarding claim 6, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 1.
However Devlin does not explicitly disclose wherein part of the front of at least one electrode has a different surface texture or surface finish than another part of the front of that electrode.
Brodnick discloses wherein the electrodes can includes various indicium including images, symbols, pointers, coloring to enable proper positioning on particular body parts (Col. 3, line 31 - Col. 4, line 38).
Therefore It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein the electrodes include various indicum. The motivation to do so being to further assist the attendant in attaching the electrodes to the patient (Brodnick, Col. 4, lines 33-34). Further, it would have been obvious to one having ordinary skill in the art to include wherein part of the top surface of at least one electrode has a different surface texture or surface finish than another part of the top surface of that electrode as this feature is well known in the art for distinguishing different items and a predictable result would ensue.
Regarding claim 7, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 6.
However Devlin does not explicitly disclose wherein the different surface texture or finish is shinier or smoother.
Brodnick discloses wherein the electrodes can includes various indicium including images, symbols, pointers, coloring to enable proper positioning on particular body parts (Col. 3, line 31 - Col. 4, line 38).
Therefore It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein the electrodes include various indicum. The motivation to do so being to further assist the attendant in attaching the electrodes to the patient (Brodnick, Col. 4, lines 33-34). Further, it would have been obvious to one having ordinary skill in the art to include wherein the different surface texture or finish is shinier or smoother as this feature is well known in the art for distinguishing different items and a predictable result would ensue.
Regarding claim 8, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 1.
However Devlin does not explicitly disclose wherein each electrode has a different color.
Brodnick discloses wherein each electrode has a different color (color coding may be added to the electrodes, E1, E2 . . . En, Col. 4, lines 36-38).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein each electrode has a different color. The motivation to do so being to further assist the attendant in attaching the electrodes to the patient (Brodnick, Col. 4, lines 33-34).
Regarding claim 9, Devlin discloses a set of electroencephalographic monitoring electrodes (array of electrodes fits easily over the temple and forehead areas where EEG signals can be acquired, Col. 3, lines 26-27) comprising:
at least four electrodes, including a first electrode for the patient's right temple, a second electrode for the patient's left temple, a reference electrode, and a ground electrode (an electrode array comprising only four electrodes for monitoring electroencephalographic signals, positioning a first electrode on the forehead, a second electrode on a first temple, a third electrode on the forehead and a fourth electrode on a second temple, claim 10, the array 10 is mounted over the forehead with its reference electrode 12b over the center of the forehead, the ground electrode 12a is placed over the forehead as well, Col. 5, lines 62-65, Figures 13(a) and 13(b)),
each electrode having a front, a back, and bottom, top, left, and right sides (each electrode has a front, a back, and bottom, top, left, and right sides, Figures 15(a) and 15(b)),
each electrode further comprising an insulating region (each electrode 12 is surrounded by a foam layer 43, Col. 5, lines 36-37), and an adhesive layer (adhesive backed foam layer, Col. 5, lines 36-37), the insulating region having a conductive region surrounded by the insulating region (conductive region 12 Is surrounded by the insulating region 43, Col. 5, lines 36-37) (each electrode 12 is surrounded by an adhesive backed foam layer 43, Col. 5, lines 36-37).
However Devlin does not explicitly disclose wherein each electrode further comprising a label, the label being separate and attached to the insulating region, nor wherein each electrode front being visually distinct from the fronts of the other electrodes by at least any two of pictorial pattern, color, shape, visible texture, reflectivity, or specularity.
Brodnick discloses wherein each electrode comprises a label, the label being separate and attached to the insulating region (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5, wherein the indicium is printed on the back of the electrodes (i.e., seen as the insulating region of the electrode), Col. 4, lines 21-24, ) the label being visually distinct from the fronts of the other electrodes (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5) wherein the label being visually distinct from the fronts of the other electrodes by at least any two of pictorial pattern, color, shape, visible texture, reflectivity, or specularity (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5 (pictorial pattern), color coding may also be added to the electrodes, Col, 4, lines 36-38).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Brodnick by including wherein each electrode comprises a label, the label being separate and attached to the insulating region wherein the label being visually distinct from the fronts of the other electrodes by at least any two of pictorial pattern, color, shape, visible texture, reflectivity, or specularity. The motivation to do so being to assist the operator in attaching the electrodes to the patient at the correct spots for the electrodes (Brodnick, Col. 4, lines 5-6).
Further Devlin does not explicitly disclose wherein the insulating region of at least one electrode comprising a pointed tab, the back of the tab not being adhesive or sticky, the tab having sufficient size to be grasped between a human forefinger and thumb.
Machon discloses a headset for detecting brain electrical activity (Abstract) wherein the insulating region of at least one electrode comprising a pointed tab (tab 422 comes to a point, Figures 3-5), the back of the tab not being adhesive or sticky (a user may lift tab 422 to pull the corresponding electrode of the subject’s skin while allowing the user to avoid touching any adhesive, Paragraph [0070]), the tab having sufficient size to be grasped between a human forefinger and thumb (tabs 422 allow the user to lift the tab to pull the corresponding electrode off of the subject’s skin, and serve a secondary function of aiding in the repositioning of electrode on the subject if necessary (i.e., can be grasped between a human forefinger and thumb), Paragraph [0070]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Machon by including wherein the insulating region of at least one electrode comprising a pointed tab, the back of the tab not being adhesive or sticky, the tab having sufficient size to be grasped between a human forefinger and thumb. The motivation to do so being to allow for a user to remove or reposition an electrode without coming into contact with adhesive (Machon, Paragraph [0070]).
Lastly Devlin does not explicitly disclose wherein each electrode front further comprising a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise.
Loutis discloses a biomedical electrode (Abstract) wherein each electrode comprises a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise (overall shape of stud 1 can be varied, Col. 8, lines 31-34, connected stud 1 with corresponding lead, such that said lead necessarily corresponds to shape to facilitate said connection (seen as a non-standard lead), Col. 4, lines 7-18).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Loutis by including wherein each electrode further comprising a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise. The motivation to do so being to allow for a connection between the stud and the lead for electromedical monitoring/diagnosis (Loutis, Col. 4, lines 7-17).
Regarding claim 10, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 9.
However Devlin does not explicitly disclose wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction, and wherein at least one of the one or more alignment indicators of the at least one electrode comprises an arrow, triangle, finger, or other pointing indicator.
Brodnick discloses wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5), and wherein at least one of the one or more alignment indicators of the at least one electrode comprises an arrow, triangle, finger, or other pointing indicator (the indicium assists the operator in attaching the electrodes to the patient at the correct spots for the electrodes, Col. 4, lines 4-6, additionally the electrodes may include a “pointer” or “reference” to help provide orientation for the electrode, Col. 4, lines 15-16, Figure 4).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction, and wherein at least one of the one or more alignment indicators of the at least one electrode comprises an arrow, triangle, finger, or other pointing indicator. The motivation to do so being to assist the operator in placing the electrode in the correct orientation (Brodnick, Col. 4, lines 15-16).
Regarding claim 11, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 9.
However Devlin does not explicitly disclose wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction, and wherein at least one of the one or more alignment indicators of the at least one electrode comprises text.
Brodnick discloses wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5),
and wherein at least one of the one or more alignment indicators of the at least one electrode comprises text (the indicium includes alphanumeric identifiers (i.e. text), Col. 4, lines 25-38, Figure 7).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction, and wherein at least one of the one or more alignment indicators of the at least one electrode comprises text. The motivation to do so being to further assist the attendant in attaching the electrodes to the patient (Brodnick, Col. 4, lines 33-34).
.
Regarding claim 12, Devlin in view of Brodnick, Machon, and Loutis discloses the electrode set of claim 9.
However Devlin does not explicitly disclose wherein at least two of the electrode have on their fronts one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction, wherein the at least two electrodes may be distinguished by different alignment indicators or different patterns of alignment indicators.
Brodnick discloses wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction (each electrode E1-E10 includes a figure (e.g. ellipse 160 for electrode E6) having an indicium (e.g., indicium 170 E6), wherein the term indicium means an identifying mark, pattern, design, or configuration that defines an electrode in the set of electrodes, Col. 3, line 31 – Col. 4, line 38, Figures 3-5),
wherein the at least two electrodes may be distinguished by different alignment indicators or different patterns of alignment indicators (the electrodes have a face that acquires more detail as it moves from left to right, (i.e., different alignment indicators), Col. 4, lines 13-14, Figure 4).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin in view of Brodnick, Machon, and Loutis to incorporate the teachings of Brodnick by including wherein at least one electrode has on its front one or more alignment indicators that visually aid in proper electrode placement by visually indicating electrode placement direction wherein the at least two electrodes may be distinguished by different alignment indicators or different patterns of alignment indicators. The motivation to do so being to further assist the attendant in attaching the electrodes to the patient (Brodnick, Col. 4, lines 33-34).
Claims 13-14, 15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Afanasewicz et al. (U.S. Pat. No. 8,577,440) herein referred to as “Afanasewicz” in view of Su et al. (U.S. PGPub. No. 2014/0275875) herein referred to as “Su” further in view of Machon et al. (U.S. PGPub. No. 2014/0257073) herein referred to as Machon, further in view of Loutis et al. (U.S. Pat. No. 6415170) herein referred to as “Loutis”.
Regarding claim 13, Afanasewicz discloses an electrode for electroencephalographic monitoring (sensor 12 and EEG monitor 14, the sensor 12 may include electrodes 16 that are used to acquire EEG signals, Col. 3., lines 5-11, Figure 1),
the electrode having a front, a back, and bottom, top, left, and right sides (electrodes each have a front, a back, and bottom, top, left, and right sides, front view, Figure 1, bottom view, Figure 2),
the electrode further comprising an insulated region, and an adhesive layer, the insulating region having a conductive region surrounded by a foam insulating region (the sensor 12A may also include an adhesive backed foam layer over the entire substrate 56, Col. 6, lines 27-30, electrodes 16A-16D are surrounded by foam insulating region over the entire substrate 56, Figure 2).
Afanasewicz further discloses wherein the sensor includes labels and/or alignment features to facilitate placement of the sensor (Col. 7, lines 5-23, Figure 4).
However Afanasewicz does not explicitly disclose wherein the electrode further comprises a label , the label being separate and attached to the insulating region, the label being colored; the label further being an unregistered label having on its surface numerous alignment indicators which are spaced periodically or randomly across the surface of the label, and which all point in substantially the same direction so as to provide a visual cue as to the placement and orientation of the electrode.
Su discloses wherein the electrode has a label, the label being separate and attached to the insulating region, the label being colored (the sensors 140, 142, 144, and 146 may include regions that are color-coded and/or include other markings (e.g., shading, cross-hatching, line, quality, indicia), Paragraph [0038], Figure 5, wherein the label is located on the sensor body 152, 154, 156, 158 (seen as the insulating region) of the respective sensor, Paragraphs [0032]-[0039]);
the label further being an unregistered label having on its surface numerous alignment indicators which are spaced periodically or randomly across the surface of the label, and which all point in substantially the same direction so as to provide a visual cue as to the placement and orientation of the electrode (the sensors 140, 142, 144, and 146 may include additional features or indicia to further facilitate the placement of the sensors, including one or more labels 180, wherein the label 180 may include on or more markings (e.g., arrows, lines, symbols, and/or shapes) and text to help a caregiver identify a desired position and orientation of each sensor (arrows for each part point in substantially the same direction and are spaced periodically according to the anatomical feature), Paragraph [0034], Figures 3-7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Afanasewicz to incorporate the teachings of Su by including wherein the electrode further comprises a label , the label being separate and attached to the insulating region, the label being colored; the label further being an unregistered label having on its surface numerous alignment indicators which are spaced periodically or randomly across the surface of the label, and which all point in substantially the same direction so as to provide a visual cue as to the placement and orientation of the electrode. The motivation to do so being help a caregiver identify a desired position and orientation of each sensor (Su, Paragraphs [0018], [0034]- [0040]). Further, it would have been obvious to one of ordinary skill in the art to include multiple alignment indicators all pointing in substantially the same direction since a predictable result would ensue.
Regarding the “unregistered label” limitation, this is seen as a product-by-process recitation. The patentability of a product does not depend upon its method of production. Determination of patentability is based upon the product itself. Since the electrode, as claimed, is deemed to have been obvious, the claimed electrode is unpatentable even if the prior product was made by a different process (MPEP 2113 I).
Afanasewicz does discloses a pointed tab (tab 580’’’, see Figure modified Figure 10A below) however Afanasewicz does not explicitly disclose wherein the insulating region of at least one electrode comprising a pointed tab, the back of the tab not being adhesive or sticky, the tab having sufficient size to be grasped between a human forefinger and thumb.
Machon discloses a headset for detecting brain electrical activity (Abstract) wherein the insulating region of at least one electrode comprising a pointed tab (tab 422 comes to a point, Figures 3-5), the back of the tab not being adhesive or sticky (a user may lift tab 422 to pull the corresponding electrode of the subject’s skin while allowing the user to avoid touching any adhesive, Paragraph [0070]), the tab having sufficient size to be grasped between a human forefinger and thumb (tabs 422 allow the user to lift the tab to pull the corresponding electrode off of the subject’s skin, and serve a secondary function of aiding in the repositioning of electrode on the subject if necessary (i.e., can be grasped between a human forefinger and thumb), Paragraph [0070]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Afanasewicz to incorporate the teachings of Machon by including wherein the insulating region of at least one electrode comprising a pointed tab, the back of the tab not being adhesive or sticky, the tab having sufficient size to be grasped between a human forefinger and thumb. The motivation to do so being to allow for a user to remove or reposition an electrode without coming into contact with adhesive (Machon, Paragraph [0070]).
Lastly Afanasewicz does not explicitly disclose wherein each electrode further comprising a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise.
Loutis discloses a biomedical electrode (Abstract) wherein each electrode comprises a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise (overall shape of stud 1 can be varied, Col. 8, lines 31-34, connected stud 1 with corresponding lead, such that said lead necessarily corresponds to shape to facilitate said connection (seen as a non-standard lead), Col. 4, lines 7-18).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Loutis by including wherein each electrode further comprising a male snap connector configured of a size or shape to allow for use of a non-standard lead known to have better shielding for lower noise. The motivation to do so being to allow for a connection between the electrode and the lead for electromedical monitoring/diagnosis (Loutis, Col. 4, lines 7-17).
Regarding claim 14, Afanasewicz in view of Su, Machon, and Loutis discloses the electrode of claim 13.
Afanasewicz further discloses wherein at least one of the alignment indicators of at least one electrode comprises an arrow, triangle, finger, or other pointing indicator (the sensor 12 may include labels or other features (e.g., arrows) to facilitate the proper placement of the electrodes 16, Col. 4, lines 32-33).
Regarding claim 15, Afanasewicz in view of Su, Machon, and Loutis discloses the electrode of claim 13.
Afanasewicz further discloses wherein the pointed tab is upward-pointing (tab 580’’’, see Figure modified Figure 10A below).
PNG
media_image2.png
195
195
media_image2.png
Greyscale
Regarding claim 19, Afanasewicz in view of Su, Machon, and Loutis discloses the electrode of claim 13.
Afanasewicz further discloses wherein the electrode is conjoined to a second electrode for electroencephalographic monitoring having a conductive region surrounded by a foam insulating region, the two electrodes being conjoined by a continuous mutual foam insulating region (the sensor 12A may also include an adhesive backed foam layer over the entire substrate 56, conjoining electrodes 16A-16D, Figures 2-4), the first electrode being a reference electrode and the second electrode being a ground electrode (electrode 16C being the ground and electrode 16B being the reference, Col. 5, lines 8-14, Figures 2-4), wherein the planar distance between the conductive regions of the two electrodes is enforced by the continuous insulating region between the two conductive regions, and said distance is at least the minimum effective distance for preventing electrical conduction between the two electrodes during cardiac defibrillation (planar distance between electrodes 16B and 16C is enforced by insulated region 56 (distance preset to prevent electrical conduction between the two electrodes), Col. 5, lines 15-42, Figures 2-6).
Regarding claim 20, Afanasewicz in view of Su, Machon, and Loutis discloses the electrodes of claim 19.
However Afanasewicz does not explicitly disclose wherein each electrode further comprises an electrode lead snap connector, wherein the two snap connectors differ in size and/or shape.
Loutis further discloses wherein each electrode further comprising an electrode snap connector (snap connector stud 1, Col.8, lines 31-34), wherein the two snap connectors differ in size and/or shape (overall shape of stud 1 can be varied, Col. 8, lines 31-34, connected stud 1 with corresponding lead, such that said lead necessarily corresponds to shape to facilitate said connection (seen as a non-standard lead), Col. 4, lines 7-18)
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Devlin to incorporate
the teachings of Loutis by including wherein each electrode further comprises an electrode lead snap connector, wherein the two snap connectors differ in size and/or shape. The motivation to do so being to allow for a connection between the electrode and the lead for electromedical monitoring/diagnosis (Loutis, Col. 4, lines 7-17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.S./Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794