DETAILED ACTION
This action is pursuant to claims filed on 11/17/2025. Claims 1 and 3-15 are pending, claim 2 has been cancelled . A final action on the merits of claims 1 and 3-15 is as follows.
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 § 102/35 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 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.
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, 3-6 and 12-15 are rejected under 35 USC § 102 as being anticipated by Kurtz et al. (hereinafter ‘Kurtz’, US 2007/0129771A1) or alternatively, under 35 U.S.C. 103 as being unpatentable over Kurtz.
Regarding claim 1, Kurtz discloses a body electrode (body electrode shown in Fig. 8B) comprising:
a first electrode (electrode S1 in Fig. 8B) configured to stimulate a muscle of a body ([0078]: electrode S1 is used to stimulate the nerve of a muscle);
a second electrode (electrode E5 in Fig. 8) and a third electrode (Electrode E3 in Fig. 8), the second electrode and the third electrode being configured to detect a physiological signal from the muscle that is stimulated by the first electrode ([0112]: E3 and E5 are sensing electrodes);
a first connection portion (connection portions highlighted below) arranged between the first electrode and the second electrode (connection portion 832 is between the first electrode S1 and second electrode E5 in the annotated image below) and a second connection portion arranged (connection portion 814 highlighted below) between the second electrode and a third electrode (connection portion 814 is between the second and third electrode as highlighted below);
wherein the first electrode, the second electrode, and the third electrode are arranged in this order in a longitudinal direction (the first electrode S1, the second electrode E5, and the third electrode E3 are arranged in a longitudinal direction in that order as seen in Fig. 8B),
wherein the first connection portion includes at least one first direction changing part (direction changing part 832 as explained below), the at least one first direction changing part configured to:
connect a plurality of longitudinal extension portions (longitudinal extension portions formed in 832 as explained below);
change a wiring direction ([0059]: the substrate has flexible circuit tracings for connecting which constitute the conductors between electrodes; [0015]: the substrate may be shaped to extend to different designated areas; this is further explained below); and
change a distance between the first electrode and the second electrode, (the extensible portions of 832 can compress/extend to change a distance between the first and second electrodes as explained below), and
wherein the second connection portion includes at least one second direction changing part (bend in extension portion 814) configured to change a direction in which the second connection portion extends (the bend allows the user to change the direction of the second connection portion), such that at least one of a distance and an angle between the third electrode and the one of the first and the second electrode is adjustable ([0109]: 814 is an extensible portion with a plurality of loop sections which allows the distance and angle between the second or first electrode and third electrode to be changed).
The first connecting portion between the first electrode S1 and the second electrode E5 is made of the single continuous substrate as seen in Fig. 8A and as stated in paragraph [0022] which states the device can be made of a unitary substrate. Furthermore, Kurtz discloses that the substrate may be flexible to at least partly conform to the body ([0009] and [0135]) and that the sensing electrode are located on separate adhesive sections and the separate adhesive sections are connected by extensible and inextensible non-adhesive portions which allows for the stimulating and some sensing electrodes to be placed at variable distances to accommodate different sizes and varying anatomy ([0112]). Because the connection portion is a long, narrow, non-adhesive portion of the substrate like extensible portion 814, it is the examiner’s opinion that section 832 functions in the same way as the extensible portion 814 because it is flexible, which means it can be compressed to form a curve, which constitutes a direction changing portion, connected to two longitudinal extension portions, which would be the straight sections adjacent to the curve. This compressed configuration can then be straightened to extend the distance between the electrodes. Additionally, the flexibility allows for the ability to change the direction of the wiring because the traces are disposed on the substrate and connected to the electrodes and to change the distance between the first and second electrodes. The flexibility of the substrate inherently imparts the ability to form these sections and function the same as the section 814.
Alternatively, it would be within the ordinary skill of one skilled in the art to duplicate the extensible portion 814 between the electrodes S1 and E5 because Kurtz has not disclosed that the extensible portion is made of any other materials or contains any special properties that makes it able to extend other than it is a longer section with snaking curves. It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Duplicating the snaking curves into the connecting portion between the first and second electrodes, S1 and E5, would allow for variations in anatomy to be easily addressed, as explained regarding the extensible portions in paragraph [0112]. Additionally, duplicating this extensible portion would impart the ability to have a direction changing portion coupled to a plurality of extension portions, to change the direction of the wiring, and to change a distance between the first and second electrodes. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the extensible area 814 to the connecting portion between the first and second electrode to allow for variations in anatomy to be easily addressed.
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Regarding claim 3, Kurtz discloses the body electrode according to claim 1, wherein the first electrode, the second electrode, and the third electrode are arranged in a row (S1, E5, and E3 are arranged in a row).
Regarding claim 4, Kurtz discloses the body electrode according to claim 1, wherein the first direction changing part and the second direction changing part are configured to change the direction in which the first connection portion extends (the bend of the first connection portion, whether from the inherent flex or the duplication of the snaking bends, can be adjusted to change the direction of the first connection part) and the direction in which the second connection portion extends (the bend in 814 can change the direction of the extension of the second connection portion), respectively, in different directions (the bends of the different portions are capable of extending in different directions due to their shapes as seen in Fig. 8 – namely the flex and the bends would allow for the first connection part to be extended towards the right and the second connection part to be extended towards the left since they are not made of a rigid material connected to rigid hinges and the claim does not specific the different directions in which they extend).
Regarding claim 5, Kurtz discloses the body electrode according to claim 4, wherein the second direction changing part is configured to change the direction in which the second connection portion extends relative to a lateral direction of the body electrode (the bends in connection portion 814 are capable of extend laterally in relation to the body electrode as seen in Fig. 8).
Regarding claim 6, Kurtz discloses The body electrode according to claim 1, further comprising:
a first electrode mounting portion (first electrode mounting portion highlighted below) on which the first electrode is mounted (S1 mounted on base portion as seen in Fig. 8b), the first electrode mounting portion being adhesive ([0110]: attachment portion 876 and 831 of the first mounting portion are adhesive);
a second electrode mounting portion (mounting portion 834 in Fig. 8B) on which the second electrode is mounted (E5 mounted on 834 as seen in Fig. 8B), the second electrode mounting portion being adhesive ([0109]: 834 is an adhesive attachment portion); and
a third electrode mounting portion (mounting portion 846 in Fig. 8B) on which the third electrode is mounted (third electrode E3 mounted on 846 as seen in Fig. 8B), the third electrode mounting portion being adhesive ([0108]: attachment portion 846 is adhesive),
wherein the first connection portion connects the first electrode mounting portion and the second electrode mounting portion to each other (the first connection portion connects the first and second electrode mounting portions as seen in Fig. 8A), the first connection portion being non-adhesive ([0112]: the separate adhesive sections are connected by non-adhesive sections), and
wherein the second connection portion connects the second electrode mounting portion and the third electrode mounting portion to each other (the second connection portion 814 connects the second electrode mounting portion and the third electrode mounting portion as seen in Fig. 8A), the second connection portion being non-adhesive ([0112]: the separate adhesive sections are connected by non-adhesive sections).
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Regarding claim 12, Kurtz discloses a body electrode unit (body electrode unit in Fig. 4) comprising:
the body electrode according to claim 1 (body electrode shown in Fig. 8 and explained above); and
a release sheet to which the body electrode is attached ([0060]: the body electrode has a backing sheet that must be removed from the areas that have an adhesive).
Regarding claim 13, Kurtz discloses the body electrode of claim 1, wherein the first connection portion includes a plurality of sets of two of the first direction changing parts (each bend is a direction changing part and as highlighted in Fig. 8B below, there are 5 total bends, 4 of which form 2 sets of 2 direction changing portions - the sets are Bends 1a and 1b and Bends 2a and 2b; this would be the same, depending on the degree of compression, between electrodes one and two or alternatively would be identical in the case of the duplication of parts as explained above).
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Regarding claim 14, Kurtz discloses the body electrode according to claim 1,
wherein the second direction changing part is configured to change the wiring direction (the second direction changing part is the bend in the portion 814 and changes the wiring direction as explained above),
wherein at least one of the first connection portion and the second connection portion includes the longitudinal extension portion (longitudinal extension portions are the straight portions adjacent to the bends in extension portion 814 in Fig. 8), and
wherein the first direction changing part and the second direction changing part change in different directions (the direction changing parts can bend in different directions based on the desired location due to the flexibility of the substrate and anatomical differences [0009] [0112]).
Regarding claim 15, Kurtz discloses the body electrode according to claim 14,
wherein the first connection portion includes the first direction changing part (as explained in the rejection of claim 1, the first connection part between electrodes S1 and E5 includes a bend as the direction changing part), and
wherein the second direction changing part is configured to:
connect the plurality of longitudinal extension portions (the bend in extension portion 814 connects to straight portions on either side of the bend which function as the longitudinal extension portions as they can increase the distance between the electrodes);
change the wiring direction ([0059]: the substrate has flexible circuit tracings for connecting which constitute the conductors between electrodes; [0015]: the substrate may be shaped to extend to different designated areas; [0109]: the extensible portion 814 is formed to have a plurality of loops extending in a snaking pattern – the extension/adjustment of this snaking pattern would change the direction of the traces that function as the wiring that connects to the electrodes); and
change the distance between the second electrode and the third electrode (the extensible portion 814 can extend to change a distance between the second and third electrodes).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code can be found under 35 U.S.C. 102/35 U.S.C. 103 Claim Rejection above.
Claim(s) 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kurtz as applied to claims 6/1 and described above, in view of Gozani et al. (hereinafter ‘Gozani’, US 2010/0210965 A1).
Regarding claim 7, Kurtz discloses the body electrode according to claim 6/1, wherein the first electrode mounting portion comprises a neutral electrode (ground electrode GND disposed on the first electrode mounting portion in Fig. 8B).
However, Kurtz is silent to the use of the ground electrode functioning to eliminate noise.
Gozani teaches an electrode patch used to stimulate and measure neuromuscular function. Gozani further teaches a neutral or inactive electrode used to eliminate noise in the signal ([0120]). Reducing noise in the signal would provide signal enhancement to Kurtz for use in therapeutic and diagnostic applications. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to combine the neutral electrode of Gozani as the ground of Kurtz in order to eliminate noise generated by the stimulation signal. This can be done easily by one of ordinary skill in the art, as demonstrated by Gozani, and leads to the predictable outcome of noise reduction.
Regarding claim 8, the Kurtz/Gozani combination discloses the invention substantially in claim 7/6/1 as described above. The combination further discloses the first electrode as part of an electrode assembly (assembly containing electrodes S1 and S2) and the presence of a cathode in the pair of stimulating electrodes S1 and S1 (Kurtz [0152]). The presence of a cathode inherently discloses the presence of an anode. Since the cathode can comprise either S1 or S2, the combination further discloses the negative electrode being closest to the neutral electrode as S1 can be the anode and is closer to the ground in Fig. 8B.
Regarding claim 9, the Kurtz/Gozani combination discloses the invention substantially in claim 7/6/1 as described above. The combination further discloses the first electrode as part of an electrode assembly (assembly containing electrodes S1 and S2) and the presence of a cathode in the pair of stimulating electrodes S1 and S1 (Kurtz [0152]). The presence of a cathode inherently discloses the presence of an anode. Since S1 or S2 can be the anode, the combination further discloses the ground electrode on the upper side of the negative electrode as evidenced by rotating Fig. 8B of Kurtz where the ground electrode is above S1 and S2.
Regarding claim 10, the Kurtz/Gozani combination further discloses the body electrode according to claim 9/7/6/1, wherein the neutral electrode is mounted between the negative electrode and the second electrode (ground electrode GND is positioned between the stimulating electrodes S1 and S2 and the second electrode E5 as seen in Fig. 8B).
Regarding claim 11, The Kurtz/Gozani combination discloses the invention substantially in claim 9/7/6/1 and described above. The combination further discloses wherein the neutral electrode is mounted on a line segment connecting a center of the negative electrode and the center of the second electrode (the line segment as drawn below connects the center of S1 and E5 and goes through the ground; this can similarly be achieved by adjusting the first connection portion to match the line segment).
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Additionally, the combination does disclose an alternate embodiment where the neutral electrode is mounted on a line segment between the center of the negative electrode and the second electrode as evidenced by Fig. 9B where S1 and S2 are in a straight line with the ground electrode GND and the second electrode E3 can be adjusted through connection 914 to create a straight line from the center of S1 and S2, through the center of the ground electrode, to the center of the second electrode E3. Additionally, a straight line can be drawn from the center of S1 through the ground electrode to the center of E3 as Fig. 9B as currently drawn. Kurtz does not limit the combinations between the embodiments and the embodiment shown in Fig. 9B is useful for measurements in the ulnar nerve ([0113]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the current embodiment of the combination with the embodiment shown in Fig. 9B to allow for use with the ulnar nerve.
Response to Arguments
Applicant's arguments filed 11/17/2025 regarding the 102/103 rejections have been fully considered but they are not persuasive.
The applicant initially argues that Kurtz does not actually teach that the first limb is made of the same material substrate and that section 832 is inextensible. This is not persuasive. Firstly, paragraph [0167] of Kurtz discloses that “the stimulus unit embodiments shown and described herein generally have a unitary substrate.” This is further shown in Fig. 8A since the entire environment facing side is a single, continuous substrate. Kurtz further discloses that the substrate is flexible to conform to the shape of the body ([0009]). Since 832 is part of the same flexible unitary substrate as section 814, it is capable of being compressed to form curves, just like section 814. Section 814 is simply a longer section which is shown compressed to form an extensible section. It is labelled as “extensible” because it is clearly shown with tight curves that can be stretched out. The extensible/inextensible nature of section 832 is never addressed by Kurzt, but is it clear from the description and Figs. 8A and 8B that it is a thin section of the flexible substrate, very similar to section 814. It is simply shorter than section 814 and shown in the fully extended shape. Additionally, since 832 is part of the flexible substrate, just like section 814, it can be compressed to form a curved shape. Once compressed, section 832 is capable of extending lengthwise or in any desired direction. The claim does not clarify any differentiating structure or materials that would distinguish over a flexible substrate that can be compressed and extended in different directions. Therefore, the rejection is maintained.
Furthermore, the applicant argues that duplicating the snakes of section 814 to section 832 is hindsight reasoning. This is not persuasive. Kurtz very clearly states the benefits of including an extensible section to better accommodate anatomical differences ([0112]). Simply lengthening and compressing section 832 to form curves that can extend is well within the level of skill for one of ordinary skill in the art. Therefore, since it is a simple duplication of parts/change of shape that would lead to the obvious benefit of better accommodating anatomical differences which is clearly disclosed by Kurtz, the argument is not hindsight reasoning. Therefore, the rejection is maintained.
Applicant’s arguments regarding claim 4 have been fully considered but are not persuasive.
The applicant argues that the first direction changing part and the second direction changing part would not extend in different directions. This is not persuasive. As described above, whether section 832 is simply compressed or section 814 is duplicated, both direction changing portions can extend in different directions based on the desired need. The substrate is flexible and the direction changing portions have 180 degrees of directions to extend into. While the simplest direction is for both to extend in a single file, straight line, the flexibility and bends allow for one to be extended in a straight line and the other to open towards the right and extend in that direction. If the material was rigid and the bends were rigid hinges, this might not be the case. However, since the bends and the substrate are flexible, they are capable of extending in different directions. The claim is simply written functionally and does not provide the structure or materials that allow for the portions to move in different directions or even state what the different directions are. Therefore, the rejection is maintained.
The rejections to the dependent claims are maintained because the rejection to the independent claim is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./ Examiner, Art Unit 3794