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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation ‘wherein the ultrasonic treatment tool is an endoscope treatment tool that is inserted into a forceps channel of an endoscope” in lines 2-3 of the claim. It is unclear whether the claim intends to positively recite the forceps channel of an endoscope or only functionally recite that the claimed ultrasonic treatment tool is configured to be inserted into a forceps channel of an endoscope. The examiner interprets the limitation to be directed to a functional recitation for examination purposes.
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.
Claims 1, 2, 5, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada et al (US 20050049525) in view of Sinelnikov et al (US 20160374710).
Regarding claims 1 and 5, Yamada et al (hereafter Yamada) discloses an ultrasonic treatment tool (figure 1) comprising: a grip part (22L) that is provided at a distal end portion of the ultrasonic treatment tool (figures 18, 19, paragraph 0094); and an ultrasound oscillator (15, 16) that is provided in the grip part, wherein the ultrasound oscillator constitutes a piezoelectric material (16), wherein the grip part includes a pair of gripping pieces (42, 15) that grips the structure, each pair of gripping pieces (15) being provided with the ultrasound oscillator (the limitation ‘being provided with’ is sufficiently broad to encompass the interaction of the ultrasound oscillator with the components of the end effector. The vibrations of the oscillator would be provided to gripping piece 42 via gripping piece 15 when they are in the closed configuration). Yamada does not disclose the piezoelectric material has a mechanical quality coefficient of 500 or more. Sinelnikov et al (hereafter Sinelnikov) teaches it was known in the art at the time of the invention for piezoelectric transducer elements for treating tissue to be made of ‘hard PZT’ which has a relative high mechanical quality factor of about 500 to 1000 and is well suited for high intensity and high duty cycle use. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make piezoelectric material of the device of Yamada further specifically comprise a ‘hard PZT’ as taught as known in the art for piezoelectric transducer elements for medical devices at the time of the invention by Sinelnikov, wherein the ‘hard PZT’ constituting the ultrasound oscillator has a mechanical quality coefficient of 500 or more, as a well suited material for high intensity and high duty cycle use, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 2, Yamada in view of Sinelnikov teaches all of the limitations set forth in claim 1, wherein a direction of ultrasonic vibration by the ultrasound oscillator is parallel to a gripping direction of the grip part (arrow, figure 17, paragraph 0092).
Regarding claim 7, Yamada in view of Sinelnikov teaches all of the limitations set forth in claim 1, wherein the ultrasonic treatment tool is an endoscope treatment tool (figure 1, paragraph 0003) that is inserted into the subject through a forceps channel of an endoscope (paragraph 0056).
Regarding claim 8, Yamada in view of Sinelnikov teaches all of the limitations set forth in claim 7, comprising: the grip part (figure 18); the ultrasound oscillator (figure 18); a tubular flexible sheath (3, paragraph 0094); an operation wire (43) provided integrally with the grip part and inserted through the flexible sheath (figure 18); and an operating part (figure 20, including 23) provided at a base end portion of the flexible sheath.
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yamada et al (US 20050049525) in view of Sinelnikov et al (US 20160374710), as applied to claim 1 above, and further in view of Funakubo et al (US 20140184020).
Regarding claim 3, Yamada in view of Sinelnikov teaches all of the limitations set forth in claim 1, however, does not disclose the ultrasonic treatment tool is driven by AC voltage signal. Funakubo discloses an ultrasonic treatment tool (1) comprising: a grip part (10) that is provided at a distal end portion of the ultrasonic treatment tool and is configured to grip a structure in a subject; and an ultrasound oscillator (11,12) that is provided in the grip part and disposed at a position facing the structure gripped by the grip part, wherein the ultrasound oscillator is driven by an AC voltage signal (paragraph 0047) having a frequency (paragraph 0050) of which a difference from a resonance frequency (paragraph 0058, 0097). Funakubo also teaches it was known in the art at the time of the invention to set maximum values at a resonance frequency, such that the drive frequency is made closer to the resonance frequency as to achieve the same amplitude (paragraph 0097) to achieve more stable melting of fat (paragraph 0098). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention drive the ultrasound oscillator of Yamada in view of Sinelnikov by an AC voltage signal in order to produce vertical vibrations, as a known energy-delivery configuration for supply ultrasonic drive signals to tissue to treat tissue as a function of time by Funakubo, since it has been held that mere substitution of art recognized equivalents at the time of the invention involves routine skill in the art. Additionally, it would have been further suggested to one with ordinary skill in the art at the time of the invention by Funakubo to make the AC voltage signal having a frequency of which a difference from a resonance frequency corresponding to a thickness dimension of the piezoelectric material is within 20%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Funakubo et al (US 20140184020) in view of Sinelnikov et al (US 20160374710), as applied to claim 1 above, and further in view of Cowley et al (US 2022/0183713).
Regarding claim 4, Funakubo in view of Sinelnikov teaches all of the limitations set forth in claim 1, wherein Cowley et al (hereafter Cowley) teaches it was known in the art at the time of the invention for ultrasonic and multi-energy surgical instrument systems for treating tissue to continuously supply the AC voltage signal for driving the ultrasound oscillator (paragraph 0106), as a known energy-delivery configuration for supply ultrasonic drive signals to tissue to treat tissue as a function of time (paragraph 0105). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the device of Yamada in view of Sinelnikov further utilize a continuously supplied AC voltage signal for driving the ultrasound oscillator, as taught as known by Cowley, as a known energy-delivery configuration for supply ultrasonic drive signals to tissue to treat tissue as a function of time and it has been held that mere substitution of art recognized equivalents at the time of the invention involves routine skill in the art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yamada et al (US 20050049525) in view of Sinelnikov et al (US 20160374710), as applied to claim 1 above, and further in view of Yoshimine (US 20170239497).
Regarding claim 10, Yamada in view of Sinelnikov teaches the ultrasonic treatment tool according to claim 1, further comprising a power supply device (9) for driving the ultrasound oscillator (paragraph 0071) and an endoscope having a forceps channel (23). Yoshimine discloses a vibration generating unit for ultrasonic vibration generated in a piezoelectric element, wherein an art-recognized equivalent power supply device (10) at the time of the invention outputs an AC voltage signal for driving the ultrasound oscillator (paragraph 0026). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention substitute the power supply device of Yamada in view of Sinelnikov with the power supply device of Yoshimine, such that it outputs an AC voltage signal for driving the ultrasound oscillator as taught as an art-recognized equivalent power supply device at the time of the invention by Yoshimine, since it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Response to Arguments
Applicant's arguments filed August 1, 2025 have been fully considered but they are not persuasive in view of the new grounds of rejection set forth below addressing the amendments to the claims. In response to applicant’s argument that ultrasonic vibration is not applied to the other forceps 42, the limitation ‘being provided with’ is sufficiently broad to encompass the interaction of the ultrasound oscillator with the components of the end effector. The vibrations of the oscillator would be provided to gripping piece 42 via gripping piece 15 when they are in the closed configuration. Therefore, applicant’s argument is not persuasive.
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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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, 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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/ANH T DANG/ Primary Examiner, Art Unit 3771
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