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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 14, 2024, February 27, 2024, and February 6, 2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant's arguments filed July 21, 2026, have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Shimizu does not suggest an elastic member with a support surface for coupling the first electrode, a sidewall extending from the support surface to which the first electrode is attached, or a fastening region opposite the support surface to which the first electrode is attached, Examiner respectfully disagrees. While it is true that Shimizu does not explicitly recite these structural properties when discussing the elastic member, the context of Shimizu’s disclosure readily allows a person having ordinary skill in the art to glean these properties from the fact that Shimizu teaches that: (1) the elastic member supports the electrode, and (2) when the electrode comes into contact with the target portion, the elastic member is deformed to align the electrode with the target and improve contact (see page 14, paragraph 6). It can be readily understood from the fact that each of the electrodes is over a corresponding clamp wing that the elastic member of Shimizu is to be between the electrodes and the clamp wings (necessarily to act as a support). Likewise, in order to deform to improve target contact, it inherently must have some relative thickness. Applicant argues (see page 13) that, rather than imply the above listed limitations, Shimizu teaches that there is no specific structure needed to create the desired level of improvement in contact. Examiner does not agree with this reading of Shimizu’s disclosure because it would suggest that any number of impractical structures would improve contact. Instead, Examiner understands Shimizu’s disclosure to teach at least:
a support surface to which the first electrode is coupled, the support surface having a perimeter (in order for Shimizu’s elastic member to support the electrode in this context there inherently must be some kind of a support surface facing the electrode),
a sidewall extending along the perimeter of the support surface to the first clamp wing from the support surface (the elastic member inherently must have some thickness in order to deform to improve contact, and the surface following that axis can be thought of as the sidewall), and
a fastening region that is at an end opposite to the support surface in the sidewall and connected to the first clamp wing (in order for Shimizu’s elastic member to support the electrode over the clamp wing in this context there must be some kind of fastening region that is at an end opposite to the support surface and coupled to the clamp wing).
Applicant has amended Claim 1 to include that the support surface should have a circumference from which the sidewall extends. Examiner agrees that Shimizu does not explicitly teach the support surface has a perimeter that is specifically a circumference (the electrode and clamp arm of Shimizu each have a perimeter that is closer to rectangular than rounded, and a support surface can be reasonably expected to follow that same shape). However, it would have been an obvious matter of design choice to make the shape of the electrodes, elastic member, and/or clamp wings rounded enough to be able to be considered to have a circumference. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Additionally, this rounded design of the arms can be observed in other embodiments of Shimizu (see e.g., Fig. 11). It should also be noted that, even if we were to accept Applicant’s assertion (see page 13) that Shimizu’s teachings would include the possibility of an O-ring as the elastic member, that would still be a structure that can be said to have a support surface, sidewall, and fastening region as broadly claimed.
Examiner does agree that Shimizu does not explicitly teach an elastic member having a sidewall with first and second points with different transformable ranges and the first electrode protruding a varying distance from the first clamp wing as determined by the varying length of the side surface that shortens between the first point and the second point of the elastic member. However, this limitation is nonetheless rendered obvious at least due to the fact that a person having ordinary skill in the art would be motivated to modify the elastic member of Shimizu to be deformable in ways that improve contact between the electrode and the target area (e.g., wrists or ankles), as suggested in Shimizu. The claimed first-point/second point architecture wherein the second point forms a shorter length from the first point closest to the hinge, the tapering side surface of the sidewall, the first and second curvature regions, the inflection point, the curved shapes, and the hollow structure are all modifications that a person having ordinary skill in the art at the effective filing date of the claimed invention could easily predict would allow the electrode to more easily and comfortably conform to targets such as a subject’s wrist or ankle in view of the contact geometries, as will be further discussed in the corresponding rejections below.
In response to applicant's argument (see pages 14-15) that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., regarding Claims 3 and 14, that the sidewall of the elastic member is formed of a softer material than are the support surface or the fastening region) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant relies on the limitation “the sidewall comprises a soft elastic material that is relatively easily transformable compared to the support surface and the fastening region” as requiring the above feature, but Examiner strongly disagrees that it does. The above limitation only requires that the sidewall comprise a soft elastic material and that it is more easily transformable compared to the support surface and fastening region. Nowhere does it actually recite that the sidewall is to be formed of a softer material than the support surface or the fastening region. It is Examiner’s position that the support surface and fastening region can be less easily transformable than the sidewall, for example, simply due to where the respective regions are attached (i.e., because the support surface is coupled to the electrode and the sidewall coupled to the clamp, it would be difficult to have deformation of either without first uncoupling the respective surfaces, unlike the sidewall that can be easily deformable from forces pressing on the electrode while using the device).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Modifying the shape and structure of a rubber support to follow and conform to the general shape of the electrode and target (e.g., a subject’s wrist or ankles) was within the level of ordinary skill of the art at the time of the claimed invention, and a person having ordinary skill in the art would be motivated to optimize the shape of the elastic support accordingly so as to encourage proper and comfortable contact between the electrode and target, as recognized by Shimizu.
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.
Claims 1, 3, and 6, 8-14, 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (JP 2020163012 A).
Regarding Claims 1, 14, and 16 Shimizu teaches a clamp body [101] comprising:
a first clamp wing [20], a second clamp wing [10] facing the first clamp wing (see Annotated Fig. 2 below), and a hinge unit [60] supporting an end of each of the first clamp wing and the second clamp wing (see Annotated Fig. 2);
an electrode unit comprising a first electrode [2a] on a surface facing the second clamp wing in the first clamp wing and a second electrode [1a] on a surface facing the first clamp wing in the second clamp wing (see Annotated Fig. 2); and
an elastic member connecting the first electrode to the first clamp wing (see provided translation of Shimizu, page 14, paragraph 6, “the electrode may be supported by an elastic member such as rubber”; for the elastic member to support the electrode in the device of Shimizu, it must be placed between the clamp wings and the electrode), wherein the elastic member comprises:
a support surface to which the first electrode is coupled (the support surface being the surface facing the electrode to support it), the support surface having a perimeter;
a sidewall extending along the perimeter of the support surface to the first clamp wing from the support surface (the sidewall being the deformable surface extending away from the clamp wing the elastic member would be on);
a fastening region that is at an end opposite to the support surface in the sidewall and connected to the first clamp wing (see provided translation of Shimizu, page 14, paragraph 6, “when the electrode comes into contact with the target portion T, the elastic member is deformed so that the electrode is aligned with the target portion T, and the contact state between the target member and the electrode can be improved”);
wherein the sidewall comprises:
a first point that is an end closest to the hinge unit (although the elastic member is not pictured, it would be at a location under the electrode such as is labeled in Annotated Fig. 2) and transformable by an external force within a transformable range (see provided translation of Shimizu, page 14, paragraph 6);
a second point that is the other end facing the first point (see e.g. Annotated Fig. 2); and
a side surface leading from the first point to the second point, wherein the side surface has a length (i.e., the thickness of the member) extending from the support surface.
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Shimizu does not specifically disclose a transformable range of the second point that is less than that of the first point. Shimizu also does not specifically disclose that the length of the side surface of the sidewall gradually shortens as the side surface is closer to the second point from the first point, wherein the second point forms a relatively short extending length from the support surface to the fastening region compared to that of the first point, and wherein the first electrode protrudes from the first clamp wing by a varying distance determined by the varying length of the side surface of the elastic member. However, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see In re Dailey et al., 149 USPQ 47). Furthermore, Shimizu teaches that the elastic member should deform to improve contact between the electrode and the target (see provided translation of Shimizu, page 14, paragraph 6, “when the electrode comes into contact with the target portion T, the elastic member is deformed so that the electrode is aligned with the target portion T, and the contact state between the target member and the electrode can be improved”). Motivated as such, a person having ordinary skill in the art at the time of the claimed invention would have found it obvious to modify the device of Shimizu such that the length of the side surface of the sidewall gradually shortens as the side surface is closer to the second point (i.e., away from the hinge). Doing so would predictably improve contact between the electrode and the skin of a subject (by urging the wrist or ankle towards the electrode rather than the hinge) with a reasonable expectation of success. The remaining referenced limitations (i.e., the varying distance that the electrode protrudes and the transformable range) would naturally flow from that change (since the electrode is located on top of the elastic member and the higher thickness of the member at one end would allow for a higher deformable range at that end). Additionally, although Shimizu does not explicitly teach the perimeter of the support is specifically a circumference (the electrode and clamp arm of Shimizu each have a perimeter that is closer to rectangular than rounded, and a support surface can be reasonably expected to follow that same shape), it would have been an obvious matter of design choice to make the shape of the electrodes, elastic member, and/or clamp wings rounded enough to be able to be considered to have a circumference without changing the functionality or efficacy of the device. In fact, rounded designs of the clamp arms can be observed in other embodiments of Shimizu (see e.g., Fig. 11).
Regarding Claim 3, Shimizu teaches a sidewall that comprises a soft elastic material that is relatively easily transformable compared to the support surface and the fastening region (implicit in the teaching that the elastic material of Shimizu is able to deform to align the electrode to the target and that the support surface and fastening regions would need to be relatively fixed in order to effectively couple the elastic member to the clamp and electrode; see provided translation of Shimizu, page 14, paragraph 6).
Regarding Claim 6, Shimizu does not specifically disclose that the first point extends from the support surface and has a curved shape at a certain curvature such that the first point is gradually away from the second point. However, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see In re Dailey et al., 149 USPQ 47). Furthermore, Shimizu teaches that the elastic member should deform to improve contact between the electrode and the target (see provided translation of Shimizu, page 14, paragraph 6, “when the electrode comes into contact with the target portion T, the elastic member is deformed so that the electrode is aligned with the target portion T, and the contact state between the target member and the electrode can be improved”). Motivated as such, a person having ordinary skill in the art at the time of the claimed invention would have found it obvious to modify the device of Shimizu to have the first point extend from the support surface and have a curved shape at a certain curvature such that the first point is gradually away from the second point. Doing so would predictably improve contact between the electrode and the skin of a subject (since both the electrodes of Shimizu and the target wrists/ankles would also have curved shapes) with a reasonable expectation of success.
Regarding Claim 8 and 19, Shimizu does not specifically disclose that the side surface comprises a first curvature region extending while curving in a direction away from an inner center of the elastic member from the support surface and a second curvature region extending while curving in a direction adjacent to the inner center of the elastic member from the first curvature region. However, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see In re Dailey et al., 149 USPQ 47). Furthermore, Shimizu teaches that the elastic member should deform to improve contact between the electrode and the target (see provided translation of Shimizu, page 14, paragraph 6, “when the electrode comes into contact with the target portion T, the elastic member is deformed so that the electrode is aligned with the target portion T, and the contact state between the target member and the electrode can be improved”). Motivated as such, a person having ordinary skill in the art at the time of the claimed invention would have found it obvious to modify the device of Shimizu such that the side surface of the elastic member comprises a first curvature region extending while curving in a direction away from an inner center of the elastic member from the support surface and a second curvature region extending while curving in a direction adjacent to the inner center of the elastic member from the first curvature region. Changing the geometry of the side surface to form this kind of “s” shape (as opposed to, for example, a straight line) would be an obvious way to adjust the deformability of the elastic member to optimize target contact.
Regarding Claim 9, Shimizu does not specifically disclose that the side surface comprises an inflection point where a reduction rate, or a rate at which the length shortens, decreases while the side surface is closer to the second point from the first point. However, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see In re Dailey et al., 149 USPQ 47). Furthermore, Shimizu teaches that the elastic member should deform to improve contact between the electrode and the target (see provided translation of Shimizu, page 14, paragraph 6, “when the electrode comes into contact with the target portion T, the elastic member is deformed so that the electrode is aligned with the target portion T, and the contact state between the target member and the electrode can be improved”). Motivated as such, a person having ordinary skill in the art at the time of the claimed invention would have found it obvious to modify the device of Shimizu such that the side surface comprises an inflection point where a reduction rate, or a rate at which the length shortens, decreases while the side surface is closer to the second point from the first point. Doing so would allow the elastic member to better support the electrode due to its curved geometry (an increasing or constant reduction rate would leave gaps at locations away from the center).
Regarding Claim 10, Shimizu teaches a first clamp wing [20] that extends in a direction from the first point to the second point and has a curved shape gradually closer to the second clamp wing [10] (see annotated Fig. 2).
Regarding Claim 11, Shimizu teaches that the support surface has a curved shape extending in a direction from the first point to the second point (implicit due to the curved shape of the electrodes [1a & 2a] and clamp wings [10 & 20] (see Annotated Fig. 2).
Regarding Claim 12, Shimizu teaches a first electrode [2a], based on a state before an external force is applied to the hinge unit, that extends in a direction from the first point to the second point and has a curved shape such that the first electrode is away from and closer again to the second electrode [1a] (see Fig. 8).
Regarding Claim 17, Shimizu teaches that the first point of the elastic member extends from the support surface and has a curved shape at a certain curvature such that the first point is gradually away from the second point (implicit due to the curved shape of the electrodes [1a & 2a] and clamp wings [10 & 20] (see Annotated Fig. 2).
Regarding Claim 18, Shimizu does not specifically disclose that the sidewall comprises a side surface leading from the first point to the second point, and the side surface comprises a length extending from the support surface, which gradually shortens as the side surface is closer to the second point from the first point. However, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see In re Dailey et al., 149 USPQ 47). Furthermore, Shimizu teaches that the elastic member should deform to improve contact between the electrode and the target (see provided translation of Shimizu, page 14, paragraph 6, “when the electrode comes into contact with the target portion T, the elastic member is deformed so that the electrode is aligned with the target portion T, and the contact state between the target member and the electrode can be improved”). Motivated as such, a person having ordinary skill in the art at the time of the claimed invention would have found it obvious to modify the device of Shimizu such that the length of the side surface of the sidewall gradually shortens as the side surface is closer to the second point (i.e., away from the hinge). Doing so would predictably improve contact between the electrode and the skin of a subject (by urging the wrist or ankle towards the electrode rather than the hinge) with a reasonable expectation of success.
Regarding Claims 13 and 20, Shimizu does not specifically disclose that the elastic member comprises a hollow structure. However, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see In re Dailey et al., 149 USPQ 47). Furthermore, Shimizu teaches that the elastic member should deform to improve contact between the electrode and the target (see provided translation of Shimizu, page 14, paragraph 6, “when the electrode comes into contact with the target portion T, the elastic member is deformed so that the electrode is aligned with the target portion T, and the contact state between the target member and the electrode can be improved”). Motivated as such, a person having ordinary skill in the art at the time of the claimed invention would have found it obvious to modify the device of Shimizu such that elastic member is hollow. Doing so would predictably make the elastic member more readily transformable (especially at the center) and therefore improve contact between the electrode and the skin of a subject (such as at the wrist or ankle) with a reasonable expectation of success.
Regarding Claim 21, Shimizu does not explicitly teach the support surface comprises at least one fastening hole configured to receive a portion of the first electrode. However, Shimizu’s wings comprise at least two fastening holes configured to receive end portions of the first electrode (see Fig. 9). As such, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to also have these fastening holes in the support surface which is located between. Doing so would be a known way to couple the electrode to the elastic member (or to both the elastic member and the wing if configured as a through-hole for the same end portions).
Regarding Claim 22, Shimizu does not explicitly teach the fastening region comprises a plurality of protrusions spaced apart from one another along a circumference of an end of the sidewall, and wherein the elastic member is coupled to the first clamp wing via the plurality of protrusions. However, Shimizu’s first electrode comprises at least two protrusions along its perimeter (the end portions on each side of the wing) to couple to the first clamp wing. As such, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to also have protrusions along the perimeter of the sidewall to couple to the first clamp wing. Doing so would be a known way to couple the wing to the elastic member. Additionally, although Shimizu does not explicitly teach the perimeter of the sidewall is specifically a circumference (the electrode and clamp arm of Shimizu each have a perimeter that is closer to rectangular than rounded, and the sidewall can be reasonably expected to follow that same shape), it would have been an obvious matter of design choice to make the shape of the electrodes, elastic member, and/or clamp wings rounded enough to be able to be considered to have a circumference without changing the functionality or efficacy of the device. In fact, rounded designs of the clamp arms can be observed in other embodiments of Shimizu (see e.g., Fig. 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN M SARCENO ROBLES whose telephone number is (571)272-8786. The examiner can normally be reached M-F: 8:30AM - 5:00PM.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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