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 and February 27, 2024 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.
Claim Rejections - 35 USC § 102
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.
Claims 1-3 and 14 are rejected under 35 U.S.C. 102(a)(1) as being taught by Shimizu et al. (JP 2020163012 A).
Regarding Claim 1, 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”).
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Regarding Claims 2 and 14, Shimizu teaches an elastic member that comprises a support surface to which the first electrode [1a] is coupled; a sidewall extending to the first clamp wing from the support surface; and a fastening region that is at an end opposite to the support surface in the sidewall and connected to the first clamp wing (the sidewall in Shimizu being the deformable surface extending away from the clamp wing the elastic member would be on; the support surface and fastening regions are taught implicitly by virtue of the structure of the clamp and electrode; 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”).
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).
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 4-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (JP 2020163012 A).
Regarding Claim 4, 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). Increasing the length of the sidewall of the elastic member near the hinge would yield this relatively higher transformable range, and it would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 more easily conforming to targets such as a subject’s wrist or ankle) with a reasonable expectation of success.
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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 more easily conforming to targets such as a subject’s wrist or ankle) 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 (by more easily conforming to targets such as a subject’s wrist or ankle) 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 more easily conforming to targets such as a subject’s wrist or ankle) 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 more easily conforming to targets such as a subject’s wrist or ankle) 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 more easily conforming to targets such as a subject’s wrist or ankle) 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 more easily conforming to targets such as a subject’s wrist or ankle) 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 clamp wings [10] and [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 15, Shimizu does not specifically disclose that the sidewall comprises: a first point that is an end and is 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated to modify the device of Shimizu such that the sidewall of the elastic member would have a first point that is an end and is 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 more easily conforming to targets such as a subject’s wrist or ankle) with a reasonable expectation of success.
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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 more easily conforming to targets such as a subject’s wrist or ankle) 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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 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). It would have been an obvious matter of design choice to make the elastic member be whatever form or shape was desired or expedient. 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”). A person having ordinary skill in the art would have been motivated 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5313940 A and IT MC1991U000041 teach clamping devices with elastic members of varying shapes.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794