DETAILED ACTION
This action is pursuant to claims filed on 4/21/2026. Claims 1 and 3-16 are pending, claim 16 has been added by the applicant. A non-final action on the merits of claims 1 and 3-16 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/21/2026 has been entered.
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 12-16 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 imparts the ability to form these sections and function the same as the section 814. Lastly, changing directions and distances are functional limitations that Kurtz is capable of performing with no specific structure provided to accomplish them. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim.
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 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).
Extending in different directions is a functional limitation which Kurtz is capable of performing. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim.
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).
Regarding claim 16, Kurtz discloses the body electrode according to claim 1, wherein one of the first direction changing part and the second direction changing part is configured to fold in the longitudinal direction ([0009]: the substrate is flexible; [0013]: the substrate comprises flexible conductors extending to the electrodes; [0059]: Stimulus unit 130 employs a substrate of a flexible material, such as a medical grade polyester film (or other materials having similar properties). The substrate may be about 3 to 8 thousandths of an inch thick. The substrate also has flexible circuit tracings formed thereon for constituting the conductors between electrodes and the input and/or output connector. Such circuit tracings may comprise silver and a dielectric layer; [0135]: the substrate has sufficient flexibility to bend to conform to the shape of the body part to which it is affixed - folding in the longitudinal direction is a functional limitation which the substrate is capable of performing since bending to conform to the body would allow the device fold to a certain degree in a longitudinal direction, the claim does not specify how far the portion must fold and while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim), and the other of the first direction changing part and the second direction changing part is configured to fold in a direction transverse to the longitudinal direction (this is also a functional limitation that the device of Kurtz is capable of performing; the bends in the extensible portion allow for folding in the direction transverse to the longitudinal direction as they can fold from side to side as they are folded to be compressed into the snaking shape - Fig. 8 shows the extensible portion folded multiple times in a direction transverse to the longitudinal direction; [0059]: Stimulus unit 130 employs a substrate of a flexible material, such as a medical grade polyester film (or other materials having similar properties). The substrate may be about 3 to 8 thousandths of an inch thick. The substrate also has flexible circuit tracings formed thereon for constituting the conductors between electrodes and the input and/or output connector. Such circuit tracings may comprise silver and a dielectric layer - the materials of the substrate and traces are capable of being folded in any direction; while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim).
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 4/21/2026 regarding the 102/103 rejections have been fully considered but they are not persuasive.
Applicant initially argues that Kurtz does not disclose a device that can “change a wiring direction” or “change a distance between the first electrode and the second electrode” as claimed. This is not persuasive. The flexibility of the substrate coupled with the length allow for both the distance between electrodes to be changed and the wiring direction to be changed. "Change a wiring direction" and "change a distance between the first electrode and the second electrode" are very broad, functional limitations and if the wiring moves at all, the direction is changed and if the curves are straightened or compressed at all, the distance between the electrodes changes. Thus, the flexibility and the length with curves allow for the direction of the wiring to be changed. These limitations are cited functionally with no specific structure to provide for this function. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim. Thus, a long, flexible substrate is able to change direction and be compressed or extended, meeting the claim limitations.
Applicant's argument that the combination is improper is not persuasive. The examiner does not rely on the embodiment of Fig. 9 for the combination and duplicating the curves would not impact functionality of the device or render the device inoperable in any way. Simply lengthening the section 832 would still allow the device to allow for placement on the medial and ulnar nerves because it can still be compressed to the original length. Furthermore, Kurtz states that various features and/or functions of elements described in relation to different embodiments may be replaced or combined with other elements of described embodiments provided that such a combination or replacement is operable ([0168]). Providing the extensible sections in the other connection portion maintains operability and is within the scope of the invention as stated by Kurtz. Lastly, allowing the ability of the stimulating and sensing electrodes to be placed at variable distances apart allows for the device to accommodate different sizes and varying anatomy. Providing the curves in the section 832 would simply aid in providing the ability to better conform to different sized users. Therefore, Kurtz does not teach away from the combination, and the combination would maintain operability and lead to the expected outcome of accommodating varying anatomy between users.
Again, this is a functional limitation and extending "in different directions" is a broad limitation. Because the substrate is flexible and made of bends, the first portion can be configured to extend towards the right and the second portion can extend towards the left, or vice versa. Even a difference in extension of 1 degree would be different directions and these extensible sections are capable of being extended in differing directions. 1. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. The connection portions of Kurtz are capable of extending in different directions, and therefore, the claim language is met.
Therefore, the rejection of claim 1 is maintained and the rejections to claims 3-15 are maintained.
Kurtz discloses the new claim 16 as described above. Claim 16 introduces additional functional limitations that the device of Kurtz is capable of performing.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794
Prosecution Insights