DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 03/11/2026.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 101
The rejection of claims 1-11 in the previous Office Action under this section and AIA section 33(a) for claims encompassing a human organism is hereby withdrawn in view of Applicant’s Amendment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 3-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0114874 A1 to Craig et al. (hereinafter “Craig”) (previously of record) in view of US 2019/0083125 A1 to Mitchell et al. (hereinafter “Mitchell”).
Regarding claim 1, Craig discloses (see abstract; Figs. 1A-8; and [0039]-[0056]) an ultrasonic treatment tool (see abstract) comprising: a grip part (20) that is provided at a distal end part (10) and that is configured to grip a biological tissue in a subject (see [0040]); an ultrasound oscillator that is configured to transmit ultrasonic oscillation to the biological tissue gripped by the grip part (22, Fig. 1A, see also [0039] which incorporates by reference US Patent No. 5,873,873; '873 discloses an ultrasound oscillator (waveguide 180) that transmits ultrasonic oscillation to the biological tissue at the end effector (see Col. 8, line 51 - Col. 10, line 45), it is readily apparent that this waveguide would operate in Craig's device since Craig does not disclose specifics of a waveguide and incorporates by reference to teach a suitable waveguide); and a stress concentration structure (28) that is provided at the grip part and that protrudes from a grip surface (26) facing the biological tissue (see Fig. 8 and [0040]-[0041]), wherein the stress concentration structure is a long protrusion disposed along a longitudinal direction of the grip part (see Figs. 1A-2 and [0040]-[0041]), and a distal end part in a protruding direction from the grip surface is formed in a continuous sawtooth shape (see Fig. 1B and [0041]), and wherein the grip part comprises a pair of grip pieces (22/24) that is configured to grip the biological tissue, and the stress concentration structure is provided at one grip piece (see Figs. 1A-B and [0040]).
Craig fails to specifically disclose wherein the ultrasound oscillator is disposed at the grip part such that it is provided at each of the pair of grip pieces. Mitchell discloses, in the same field of endeavor of ultrasonic treatment tools (see abstract), a grip part (jaw assembly 400) provided at a distal end part (102) that comprises a pair of grip pieces (402/404) that is configured to grip a biological tissue in a subject (see [0070]), an ultrasound oscillator (500) that is configured to transmit ultrasonic oscillation to the biological tissue gripped by the grip part (see [0100]-[0109]), wherein the ultrasound oscillator is disposed at the grip part such that it is provided at teach of the pair of grip pieces (see [0100]/[0108]/[0110]) for the purpose of placing the transducers on opposing arms of a clamp to achieve a well-confined and controlled high intensity region midline between the transducers (see [0110]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Craig’s device with the ultrasonic oscillator disposed at both grip pieces as taught by Mitchell in order to place the transducers on opposing arms of a clamp to achieve a well-confined and controlled high intensity region midline between the transducers.
The combination of Craig and Mitchell would further disclose (claim 5) wherein the ultrasound oscillator is composed of a piezoelectric material (Craig: see Col. 7, lines 18-25 of '873; Mitchell: [0101]) and is driven by an alternating current voltage signal (Craig: see Col. 4, lines 11-56 of '873) having a frequency at which a difference from a resonance frequency corresponding to a thickness dimension of the piezoelectric material is within 20% (Craig: see Col. 4, lines 11-35; Col. 6, line 21 - Col. 7, line 53; Col. 9, lines 15-24; Col. 10, lines 7-18 of '873); (claim 6) wherein the piezoelectric material is lead zirconate titanate (Craig: see Col. 7, lines 23-25 of '873); (claim 7) wherein a Curie point of the piezoelectric material is 200°C or more (Craig: see Col. 7, lines 23-25 of '873, lead zirconate titanate has an inherent material property of having a Curie point of more than 200°C); (claim 8) wherein an alternating current voltage signal for driving the ultrasound oscillator is continuously supplied (Craig: see Col. 5, lines 21-23 & 55-56; Col. 7, lines 44-53 of '873); (claim 9) wherein the grip part is configured to grip a blood vessel which is the biological tissue (Craig: see [0049]); and (claim 10) which is a surgical treatment tool comprising an insertion part (Craig: 12; or 150 in '873) that is installed consecutively to a base end of the grip part and an operating part (Craig: 130 in '873) that is installed consecutively to a base end of the insertion part (Craig: see Fig. 2/4 and Col. 8, lines 51-54 of '873).
The combination of Craig and Mitchell discloses the invention substantially as claimed, however, with respect to claims 3-4, Craig/Mitchell fails to specifically disclose wherein the stress concentration structure and a grip part surface facing the stress concentration structure have a hardness of 40 HBW or more in Brinell hardness. Brinell hardness is a standard used for measuring the inherent hardness of a given material or structure. Therefore, Craig's end effector 20 would inherently have a given but unspecified Brinell hardness because this is an inherent material property. Craig further discloses that the end effector 20 must be arranged so that it can sufficiently overcome the viso-elasticity of the tissue to be clamped by among other things being sufficiently hard to adequately compress/cut the tissue (see [0008]-[0010]). By providing a varying height surface in the tissue pad, a single application of clamping force is sufficient to both cut the tissue and coagulate on either side of the cut during clamping (see [0012]-[0013]) - this clamping force is transmitted to the tissue to be gripped and thus treatment of incising the tissue can be performed more efficiently. Thus, Craig discloses a result effective variable - the clamping force must be sufficient to overcome the visco-elasticity of the tissue in order to provide a proper incising of the tissue, with the hardness of the device being an apparent component - the device must have sufficient hardness to counteract the visco-elasticity of the tissue to impart a sufficient clamping force. Note that Applicant's specification merely states at [0036] that the recited Brinell hardness serves to further transmit stress to the tissue to be gripped to more efficiently perform incising of the tissue. Craig's device sees the same benefit - the hardness as part of the clamping force helps to transmit stress to the tissue to cut and coagulate the clamped tissue to incise it. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Craig to have a hardness in the claimed Brinell range, as it involves only adjusting the hardness to ensure sufficient clamping of the tissue. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Craig by making the hardness within the claimed Brinell range as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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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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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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