CTNF 18/990,546 CTNF 85182 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-30-02 AIA 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. 07-34-01 Claims 1-6 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. Regarding claim 1, the claim recites the terminology of “the heat generated by a treatment is large” therein. The Examiner is of the position that the defining of the heat generated as “large” is a relative term which renders the claim indefinite. The term “large” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Said differently, the Examiner is unaware of any standard definition of term of degree that quantifies levels of heat generated due an ultrasonic treatment as large (or small, or medium, or any other relative terminology) so as to effectively determine the metes and bounds of the claim. Claims 2-6 are rejected due to their dependency on claim 1. Appropriate correction is required. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Niiyama et al. (US Pat. Pub. 2022/0265307 A1) further in view of Akagane et al (WO 2018/087838 A1) . Regarding claim 1, Niiyama provides for an ultrasonic treatment tool comprising a vibration transmission portion having a distal end provided with a treatment portion configured to treat a treatment target, the vibration transmission portion being configured to transmit ultrasonic vibration from a proximal end toward the treatment portion of the vibration transmission portion ( 16/6/13 ), a holding portion configured to be opened from and closed to the treatment portion (jaw 21 ), and a resin pad (pad 25 made if resin as in a least [0032]) that is held to the holding portion and has a gripping face to grip the treatment target between the resin pad and the treatment portion (See figure 1B), the resin pad including a first region including a gripping position at which the treatment target is gripped, the first region being a region in which heat generated by a treatment is large (a first region of 25 for example towards the distal end of the pad 25 ), and a second region other than the first region (a second region different from the first defined above and proximal to the first region), the holding portion including a third region facing the first region and a fourth region facing the second region (respective portions of the jaw 21 facing ones of the first/second region), the holding portion being configured such that a heat capacity per unit length of the third region is larger than a heat capacity per unit length of the fourth region (see figure 7C with a region at the distal most 367 being greater than the capacity at the region of an adjacent 365 ), the holding portion including a jaw body configured to hold the resin pad (see figures 1B and 7C), and the jaw body including a body portion to which the resin pad is attached ( 21 is a jaw as in the figures and holds 25 ). Niiyama fails to provide for the inclusion of an outer shell provided on an outer surface different from an outer surface to which the resin pad is attached, of outer surfaces of the body portion, the outer shell being made of a heat insulating material. Akagane provides for a similar device as that of Niiyama with an alternative manner of arranging a jaw of an ultrasonic-based treatment device. Therein, Akagane provides for the inclusion of a holding portion configured to be opened from and closed to a treatment portion (end effector 50a opening/closing relative to 150 ) and a pad that is held to the holding portion and has a gripping face to grip the treatment target between the pad and the treatment portion ( 160 ), the holding portion including a jaw body configured to hold the resin pad, and the jaw body including a body portion ( 62/64/65) to which the pad is attached (see figure 10), and an outer shell provided on an outer surface different from an outer surface to which the pad is attached, of outer surfaces of the body portion, (see figure 10 with the outer shell at 63 ) the outer shell being made of a heat insulating material ( 63 is discloses as “an electrically insulating material such as a resin material”). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the alternative construction of the remainder of the jaw portion of the holding portion as in Akagane to the jaw portion of the holding portion of Niiyama to provide for a known manner of constructing an holding portion that opens/closes relative to a treatment portion of an ultrasonic device. The Examiner is of the position hat one of ordinary skill would readily appreciate that either arrangement would function equally as well as one another an with a reasonable expectation of success given the substantially similarity in use and construction, as well as for the interaction between the resin pad and treatment portion in each. Regarding claim 2, Niiyama provides that, in the holding portion, a volume per unit length of the third region is larger than a volume per unit length of the fourth region (via the differing cross-sections shown in figure 7B between the thickened portions 367 and the slots 365 ; see also [0056]). Regarding claim 3, Niiyama provides that, in the holding portion, a specific heat of the third region is larger than a specific heat of the fourth region (via the differing cross-sectional sizes shown in figure 7B between the thickened portions 367 and the slots 365 ; see also [0056]). Regarding claim 4, Niiyama provides that the first region is distally disposed, compared with the second region (see the rejection of claim 1 defining the first and second regions as such). Regarding claim 5, in view of the combination in the rejection of claim 1, the combined construction of the holding portion would result in the volume per unit length of the body portion being larger than a volume per unit length of the outer shell. Akagane displays that the outer shell ( 63 ) possess less volume than the structure of 62/4/65 as shown in figure 10). The Examiner further finds that the construction of the outer shell to have a volume per unit length of the body portion being larger than a volume per unit length of the outer shell would have been an obvious consideration in view of the general structural arrangement and direction in Akagane given that 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. Regarding claim 6, Niiyama provides that the holding portion is made of an electrically conductive material (see [0054] providing the use of a conductive material in the form of metal for 329 as the holding portion of the jaw). Niiyama fails to provides that the ultrasonic treatment tool is configured to supply high frequency power between the holding portion and the treatment portion to supply high frequency energy to the treatment target. The combination in rejection of claim 1 has relied upon the disclosure in Akagane to provide for an alternative construction of the holding portion of the device. Akagane further provides for such to include an electrically conductive portion in the form of an electrode on the holding portion 64/65 and for such to be configured to supply high frequency power between the holding portion and the treatment portion to supply high frequency energy to the treatment target (see figure 10 providing for 72 of the treatment portion to be conductive as well such that energy can be supplied between 64/65 and 72 ). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have further provided a conductive portion on the treatment potion of Niiyama in view of the teaching in Akagane to provide for an alternative structure of the ultrasound treatment device that can treat tissue both by ultrasound energy as well as high-frequency energy. Such allows for the device to effectively incise tissue while also providing for effective coagulation of tissue at the treatment site so as to reduce/eliminate bleeding. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794 Application/Control Number: 18/990,546 Page 2 Art Unit: 3794 Application/Control Number: 18/990,546 Page 3 Art Unit: 3794 Application/Control Number: 18/990,546 Page 4 Art Unit: 3794 Application/Control Number: 18/990,546 Page 5 Art Unit: 3794 Application/Control Number: 18/990,546 Page 6 Art Unit: 3794 Application/Control Number: 18/990,546 Page 7 Art Unit: 3794
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