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 April 17, 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, sidewall, or fastening region, 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: (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 in Shimizu that the elastic member is to be between the electrodes and clamp wings for it to be of any support. Likewise, in order to deform to improve target contact, it inherently must have some relative thickness. The limitations in question only broadly require:
a support surface to which the first electrode is coupled (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 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)
a fastening region that is at an end opposite to the support surface in the sidewall and connected to the first clamp wing (likewise, 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 connected to the clamp wing).
Shimizu does not just broadly teach an elastic member “somewhere” as Applicant suggests; it teaches an elastic member with a specific purpose at a specific location (supporting an electrode on the wings of a clamp), which suggests some structure.
Regarding Applicant’s assertion that Shimizu does not suggest an elastic member having a sidewall with opposite first and second points, where the first point is transformable by a transformable range that is greater than the transformable range of the second point: while that may be so, this limitation is nonetheless rendered obvious, even leaving considerations of design choice aside, 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 of claims 5-6 and 16-17, the tapering side surface of the sidewall of claims 7 and 19, the first and second curvature regions recited in claims 8 and 19, the inflection point recited in claim 9, the curved shapes recited in claim 10-12, and the hollow structure recited in claims 13-20 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 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 the general shape of the electrode and target (e.g., a subject’s wrist or ankles) and be deformable to encourage comfortable contact as per the limitations recited above is within the level of ordinary skill of the art at the time of the claimed invention.
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 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (JP 2020163012 A).
Regarding Claims 1 and 14, Shimizu teaches a clamp body [101] comprising a first clamp wing [10], a second clamp wing [20] 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 [1a] on a surface facing the second clamp wing in the first clamp wing and a second electrode [2a] 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).
PNG
media_image1.png
457
616
media_image1.png
Greyscale
Shimizu also teaches an elastic member that comprises a support surface to which the first electrode [1a] is coupled (the support surface being the surface facing the electrode to support it); a sidewall extending 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); and 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”).
Shimizu does not specifically disclose that the sidewall comprises: a first point that is an end closest to the hinge unit and transformable by an external force within a transformable range; and a second point that is the other end facing the first point and of which a transformable range is less than that of 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). Simply gradually increasing the length of the sidewall of the elastic member as it approaches the hinge would yield this relatively higher transformable range. 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 sidewall has a first point that is an end closest to the hinge unit and transformable by an external force within a transformable range; and a second point that is the other end facing the first point and of which a transformable range is less than that of the first point. 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 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 is able to deform to align the electrode to the target; see provided translation of Shimizu, page 14, paragraph 6).
Regarding Claim 5, Shimizu does not specifically disclose that the second point forms a relatively short extending length from the support surface to the fastening region compared to that of 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 to have the second point form a relatively short extending length from the support surface to the fastening region compared to that of the first point. 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 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 7, 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 has 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 sidewall of the elastic member comprises a side surface leading from the first point to the second point, and the side surface has a length extending from the support surface, which gradually shortens as the side surface is closer to the second point from the first point. 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 Claim 8, 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. 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 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 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 Claim 10, Shimizu does not specifically disclose a first clamp wing 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. 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 first clamp wing extends in a direction from the first point to the second point and has a curved shape gradually closer to the second clamp wing. 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 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 [1a], 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 [2a] (see Fig. 8).
Regarding Claim 16, Shimizu does not specifically disclose that the second point of the elastic member forms a relatively short extending length from the support surface to the fastening region compared to that of 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 second point forms a relatively short extending length from the support surface to the fastening region compared to that of the first point. 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 Claim 17, Shimizu does not specifically disclose 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. 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 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. Doing so would predictably improve contact between the electrode and the skin of a subject (by more easily conforming to curved targets such as a subject’s wrist or ankle) with a reasonable expectation of success.
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 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. Doing so would predictably improve contact between the electrode and the skin of a subject (by more easily conforming to curved targets such as a subject’s wrist or ankle) with a reasonable expectation of success.
Regarding Claim 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 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. Doing so would predictably improve contact between the electrode and the skin of a subject (by more easily conforming to curved targets such as a subject’s wrist or ankle) 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 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, Joseph Stoklosa can be reached at (571) 272-1213. 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.
/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights