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 .
Response to Amendment
This office action is responsive to the amendment filed on 12/28/2025. As directed by the amendment: claims 1, 5, and 6 have been amended and claims 7-13 have been added. Thus, claims 1-13 are presently pending in this application.
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, 2, 5, 6, and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beaupre (US 20180235650 A1) as evidenced by Fan et al. (US 20150297255 A1).
Regarding claim 1 Beaupre discloses (fig. 1-2 and 6-10) a vibration transmission member comprising:
a main body 12 that extends from a front end toward a proximal end of the vibration transmission member to define a longitudinal axis direction (see fig. 1 and [0031]) and that has a proximal end 14 to which an ultrasonic transducer 82 configured to generate ultrasonic vibration (see [0034]) is connected (see [0036]); and
an end effector (24+18C) that is installed at a front end of the main body 12 (see fig. 1 and 5) and that has a curved shape (see [0031]) which curves in a first direction (upward direction as viewed in fig. 6) toward the front end of the vibration transmission member (see fig. 6), the first direction being orthogonal to the longitudinal axis direction (see fig. 6), the end effector being configured to apply the ultrasonic vibration to a body tissue to treat the body tissue (see [0030]),
the end effector (24+18C) including a constricted portion 36 configured to increase in size in a second direction (left right direction, as viewed in fig. 9) toward a front end of the constricted portion (see fig. 9-10 and [0062]), the second direction being orthogonal to the longitudinal axis direction (top/bottom direction as viewed in fig. 9) and the first direction (out of the page direction as viewed in fig. 9), the constricted portion being configured to decrease in size in the first direction (see annotated fig. below), and
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a wide portion (portion distal 36) that is provided on a front end side of the constricted portion 36 (see fig. 5, 10, and [0062]-[0063]) and that has a size in the second direction that is greater than a size in the first direction (see fig. 5),
a node (node at 17B; see [0040]) being set on a proximal end side of the constricted portion (see fig. 1 and 5), and
a cross-sectional area adjustment portion (29-36) that includes the constricted portion 36 and that has a size along the longitudinal axis direction to be within a predetermined range (see fig. 10) being set to have a cross-sectional area orthogonal to the longitudinal axis direction to be within a predetermined range (see fig. 5-6).
Beaupre does not specify that the node is a stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated.
A node disclosed in Beaupre is known to be as claimed (is a stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated), as evidenced by Fan (see [0140]). Thus, the node Beaupre inherently is the claimed stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated.
Regarding claim 2 Beaupre further discloses (fig. 1-2 and 6-10) the end effector is configured to decrease in size in the first direction toward the front end of the vibration transmission member (curve of 26 decreases the size towards the front end, see fig. 5 and 9).
Regarding claim 5 Beaupre discloses (fig. 1-2 and 6-10) a treatment tool comprising:
a cylindrical sheath 60 (see fig. 1 and [0031]);
a vibration transmission member 12 that is inserted into the cylindrical sheath 60 and that has a front end protruding out from the cylindrical sheath 60 (see fig. 1 and [0032]); and
an ultrasonic transducer 82 configured to generate ultrasonic vibration (see [0034]),
the vibration transmission member including:
a main body 12 that extends from a front end toward a proximal end of the vibration transmission member to define a longitudinal axis direction (see fig. 1 and [0031]) and that has a proximal end 14 to which an ultrasonic transducer 82 (see [0034]) is connected (see [0036]); and
an end effector (24+18C) that is installed at a front end of the main body 12 (see fig. 1 and 5) and that has a curved shape (see [0031]) which curves in a first direction (upward direction as viewed in fig. 6) toward the front end of the vibration transmission member (see fig. 6), the first direction being orthogonal to the longitudinal axis direction (see fig. 6), the end effector being configured to apply the ultrasonic vibration to a body tissue to treat the body tissue (see [0030]),
the end effector (24+18C) including a constricted portion 36 configured to increase in size in a second direction (left right direction, as viewed in fig. 9) toward a front end of the constricted portion (see fig. 9-10 and [0062]), the second direction being orthogonal to the longitudinal axis direction (top/bottom direction as viewed in fig. 9) and the first direction (out of the page direction as viewed in fig. 9), the constricted portion being configured to decrease in size in the first direction (see annotated fig. below), and
a wide portion (portion distal 36) that is provided on a front end side of the constricted portion 36 (see fig. 5, 10, and [0062]-[0063]) and that has a size in the second direction that is greater than a size in the first direction (see fig. 5),
a node (node at 17B; see [0040]) being set on a proximal end side of the constricted portion (see fig. 1 and 5), and
a cross-sectional area adjustment portion (29-36) that includes the constricted portion 36 and that has a size along the longitudinal axis direction to be within a predetermined range (see fig. 10) being set to have a cross-sectional area orthogonal to the longitudinal axis direction to be within a predetermined range (see fig. 5-6).
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Beaupre does not specify that the node is a stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated.
A node disclosed in Beaupre is known to be as claimed (is a stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated), as evidenced by Fan (see [0140]). Thus, the node Beaupre inherently is the claimed stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated.
Regarding claim 6 Beaupre further discloses (fig. 1-2 and 6-10) the constricted portion 36 is positioned on an outside of the cylindrical sheath 60 (see fig. 1), and the stress concentration portion (node at 17B) is positioned inside the cylindrical sheath 60 (see fig. 1).
Regarding claim 9 Beaupre further discloses the stress concentration portion (node at 17B) is positioned inside the cylindrical sheath 60 (see fig. 1).
Regarding claims 10 and 11 Beaupre further discloses (fig. 1-2 and 5-10) the main body 12 includes a cross- sectional area decreasing portion 18C provided on the proximal end side of the constricted portion (29-36; see fig. 5 and [0042]), and wherein the cross-sectional area decreasing portion 18C has a slanted surface that is located on a curved side in which the end effector is curved (see annotated fig. 6 below), the slanted surface being slanted toward an opposite side of the curved side and toward the front end of the vibration transmission member (see annotated fig. 6 below).
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Regarding claims 12 and 13, Beaupre further discloses (fig. 14) the wide portion has a flat shape with the size in the second direction being greater than the size in the first direction (see [0065] and annotated fig. 14 below).
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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 3, 4, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Beaupre as evidenced by Fan.
Regarding claims 3 and 4, Beaupre discloses the claimed invention substantially as claimed, as set forth above for claim 1. Beaupre (embodiment of fig. 1) is silent regarding the main body includes a cross-sectional area decreasing portion configured to decrease in cross-sectional area orthogonal to the longitudinal axis direction toward the front end of the vibration transmission member, the cross-sectional area decreasing portion being connected to a proximal end of the cross- sectional area adjustment portion; the cross- sectional area decreasing portion includes a slanted portion that is positioned on a curved side in which the end effector is curved, the slanted portion being slanted to an opposite side of the curved side toward the front end of the vibration transmission member.
However Beaupre teaches in a variant embodiment (fig. 3-4) where the main body 412 includes a cross-sectional area decreasing portion 419 configured to decrease in cross-sectional area orthogonal to the longitudinal axis direction toward the front end of the vibration transmission member (see fig. 4 and [0043]), the cross-sectional area decreasing portion being connected to a proximal end of the cross- sectional area adjustment portion (419 is connected to 24 which comprises the cross- sectional area adjustment portion); the cross- sectional area decreasing portion 419 includes a slanted portion (see annotated fig. 4) that is positioned on a curved side in which the end effecto0 24r is curved (see fig. 3), the slanted portion being slanted to an opposite side of the curved side toward the front end of the vibration transmission member (see annotated fig. 4 below).
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Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Beaupre (fig. 1) to have the main body includes a cross-sectional area decreasing portion configured to decrease in cross-sectional area orthogonal to the longitudinal axis direction toward the front end of the vibration transmission member, the cross-sectional area decreasing portion being connected to a proximal end of the cross- sectional area adjustment portion; the cross- sectional area decreasing portion includes a slanted portion that is positioned on a curved side in which the end effector is curved, the slanted portion being slanted to an opposite side of the curved side toward the front end of the vibration transmission member as taught by Beaupre (fig. 3-4), for the purpose of dampening any vibrations having frequencies other than the drive frequency (see Beaupre [0043]).
Regarding claims 7 and 8, Beaupre discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 5. Beaupre is silent regarding the cross-sectional area adjustment portion has a change rate of the cross-sectional area within +15% relative to a minimum cross-sectional area of the cross-sectional area adjustment portion.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Beaupre to have the cross-sectional area adjustment portion has a change rate of the cross-sectional area within +15% relative to a minimum cross-sectional area of the cross-sectional area adjustment portion since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Beaupre would not operate differently with the claimed change rate of the cross-sectional area as the blade would still cut tissue. Further, applicant places no criticality on the range claimed, indicating simply stating it in the specification.
Response to Arguments
Applicant's arguments filed 12/28/2025 have been fully considered but they are not persuasive.
Applicant argues that Beaupre fails to teach the dimensional structural and functional relationship between the constricted portion and the stress concentration portion. Specifically that the amendment reciting the constricted portion is configured to increase in size in a second direction toward a front end of the constricted portion and further recite that the constricted portion being configured to decrease in the first direction and increase in the second direction “specifies a structural dimensional relationship between the first direction (the direction in which the end effector curves) and the second direction (orthogonal to both the longitudinal axis direction and the first direction) that establishes how the constricted portion transitions to achieve stress management objectives”. The Office respectfully disagrees. The amendment recites a structure for the constricted portion (he constricted portion is configured to increase in size in a second direction toward a front end of the constricted portion and further recite that the constricted portion being configured to decrease in the first direction and increase in the second direction) and a stress concentration portion on the proximal end of the constricted portion. No further structure of the stress concentration portion nor of the relationship between the constricted portion and the stress concentration portion is claimed. The claim language does not relate the structure of the constricted portion to that of the stress concentration portion as applicant has argued.
Applicant further arguers “the present disclosure teaches that the dimensional relationship of the constricted portion is part of a coordinated design to manage stress concentration in ultrasonic vibration transmission. The as-filed specification explains that "the variation of the cross-sectional area is kept at a moderate level by increasing the cross-sectional area in the vicinity of the constricted portion 93 (at the distance P5 from the front end of the vibration transmission member 9) and by reducing the cross-sectional area in the vicinity of the portion between the distances P6 from the front end of the vibration transmission member 9 and P7 from the front end of the vibration transmission member 9." (As-filed specification at page 14). The present disclosure provides a comparative example demonstrating that without this controlled dimensional relationship, "there is an increase in the variation of the cross-sectional area" which causes "concentration of stress attributed to lateral vibrations." (As-filed specification at page 15)”. As even argued by applicant there are features in the disclosure. As currently written the claim language does not reflect the same scope as the disclosure. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the dimensional relationship of the constricted portion is part of a coordinated design to manage stress concentration in ultrasonic vibration transmission… the variation of the cross-sectional area is kept at a moderate level by increasing the cross-sectional area in the vicinity of the constricted portion 93 (at the distance P5 from the front end of the vibration transmission member 9) and by reducing the cross-sectional area in the vicinity of the portion between the distances P6 from the front end of the vibration transmission member 9 and P7 from the front end of the vibration transmission member 9… there is an increase in the variation of the cross-sectional area" which causes concentration of stress attributed to lateral vibrations) 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 further arguers that in the claim language, a stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated being set on a proximal end side of the constricted portion, the phrase “ ‘being set’ indicates intentional design and positioning for a functional purpose, not merely the existence of a vibrational node”. The Office respectfully disagrees. Under broadest reasonable interpretation “being set” simply means at a position or location. Applicant further argues that the position of The Office that a node reads on a stress concentration portion “conflates the natural occurrence of vibrational nodes with the intentional positioning of a stress concentration portion to achieve stress management objectives. Fan mentions that "at node positions the stress in the directions perpendicular to the longitudinal axis C is maximized." (Fan at [0140]). This confirms that nodes experience maximum stress, but it does not teach intentionally positioning a stress concentration portion relative to a constricted portion to alleviate stress concentration in the front end portion”. The Office respectfully disagrees. The claim language recites “a stress concentration portion at which stress attributed to the ultrasonic vibration is concentrated being set on a proximal end side of the constricted portion”. No specific structure is recited for the stress concentration portion nor any specific function other than to have stress concentrated there. Fan discloses that nodes experience maximum stress, thus the claim language is taught.
Applicant further argues “The present disclosure teaches that the stress concentration portion is intentionally positioned through the cross-sectional area adjustment portion to move stress concentration away from the constricted portion region. The as-filed specification explains that the stress concentration portion 90 is positioned to the adjacent side to the frontmost node position and is set on the proximal end side Ar2 of the constricted portion 93. (As-filed specification at page 16). The specification further explains that this positioning makes "it possible to alleviate the concentration of stress in the front end portion in the vicinity of the constricted portion 93”. As even argued by applicant these are features in the disclosure. As currently written the claim language does not reflect the same scope as the disclosure. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the stress concentration portion is intentionally positioned through the cross-sectional area adjustment portion to move stress concentration away from the constricted portion region …the stress concentration portion 90 is positioned to the adjacent side to the frontmost node position and is set on the proximal end side Ar2 of the constricted portion 93… this positioning makes "it possible to alleviate the concentration of stress in the front end portion in the vicinity of the constricted portion 93) 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 further argues that “The independent claims also recite a cross-sectional area adjustment portion that includes the constricted portion and that has a size along the longitudinal axis direction to be within a predetermined range being set to have a cross-sectional area orthogonal to the longitudinal axis direction to be within a predetermined range. This element requires that both the longitudinal extent and the cross-sectional area of the cross-sectional area adjustment portion must be controlled within predetermined ranges, and that this controlled region includes the constricted portion” and Beaupre fails to teach this dual constraint on dimensional control. The Office respectfully disagrees. The Office notes that the language “within a predetermined range” simply means within a some range that has been determined before some time. In other words a value that has been predetermined before use of the device. Beaupre teaches a cross-sectional area adjustment portion that includes the constricted portion and that has a size along the longitudinal axis direction to be within a predetermined range being set to have a cross-sectional area orthogonal to the longitudinal axis direction to be within a predetermined range.
Applicant further argues “The present disclosure teaches that the cross-sectional area adjustment portion achieves stress management through controlled dimensional variation. The as-filed specification provides a comparative analysis showing that maintaining controlled cross-sectional area variation is necessary to prevent stress concentration. The specification teaches that in the vibration transmission member 9' representing a comparative example, as shown in FIG. 4, in the vicinity of a constricted portion 93' (at the distance P4' from the front end of the vibration transmission member 9'), there is an increase in the variation of the cross-sectional area. (See, as-filed specification at page 14). The specification explains that this increased variation causes "concentration of stress attributed to lateral vibrations that is generated due to the curved shape in the end effector 92" in a stress concentration portion positioned near the constricted portion. (As-filed specification at page 14)”. As even argued by applicant these are features in the disclosure. As currently written the claim language does not reflect the same scope as the disclosure. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the cross-sectional area adjustment portion achieves stress management through controlled dimensional variation …a comparative analysis showing that maintaining controlled cross-sectional area variation is necessary to prevent stress concentration… the vibration transmission member 9' representing a comparative example, as shown in FIG. 4, in the vicinity of a constricted portion 93', there is an increase in the variation of the cross-sectional area…this increased variation causes "concentration of stress attributed to lateral vibrations that is generated due to the curved shape in the end effector 92" in a stress concentration portion positioned near the constricted portion) 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).
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 KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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