CTNF 18/865,571 CTNF 96268 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 Objections 07-29-01 AIA Claim s 10, 11, and 20 are objected to because of the following informalities: Claim 10, line 2: “waveguide” should read –wave guide--; Claim 11, line 9: “electrically conductive” should read --are coated with an electrically conductive material--; and Claim 20, line 2: “waveguide” should read –wave guide --. Appropriate correction is required. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 3, and 6-9 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Akagane, US 20170000515, herein referred to as “Akagane” . Regarding claim 1, Akagane discloses a combination ultrasonic and electrosurgical surgical instrument (Figure 1) , comprising: a housing (Figure 1: handpiece 12) ; an ultrasonic transducer disposed within the housing (Figure 2: ultrasonic transducer 22) ; and a wave guide (Figure 2: horn member 23) configured to support an ultrasonic blade (Figure 1: probe 17) operably coupled to the ultrasonic transducer ([0024]) , the ultrasonic blade configured to receive ultrasonic energy produced by the ultrasonic transducer ([0022]-[0023]) , the ultrasonic blade tapered along both a vertical and a horizontal axis defined therealong (Figure 3: probe 17 is tapered along the vertical axis and horizontal axis at neck portion 33) and defining an elongated edge on an upper surface (Figure 3: outer peripheral portion 37) thereof terminating at a spatula-like distal end (Figure 3: treatment section 32) , wherein the elongated edge and side of the spatula-like distal end are coated with an electrically conductive material ([0026]: “The probe 17 is formed into a rod of, for example, a biocompatible metallic material (such as titanium alloy). ” and [0028]) and are both adapted to connect to a source of electrosurgical energy ([0033]) such that activation of the electrosurgical energy source and the ultrasonic transducer treat tissue with both electrosurgical energy and ultrasonic energy ([0023]) . Regarding claim 3, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 1, wherein the ultrasonic transducer is energized by the source of electrosurgical energy (Figure 1: power source unit 13 and [0031]) . Regarding claim 6, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 1, wherein both ultrasonic and monopolar energy are simultaneously provided to the elongated edge to quickly and finely dissect tissue ([0026]) . Regarding claim 7, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to The combination ultrasonic and electrosurgical surgical instrument according to wherein monopolar energy is provided to the elongated edge to dissect tissue ([0033]) . Regarding claim 8, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 1, wherein the side surface of the spatula-like distal end is used to simultaneously treat tissue with ultrasonic energy and monopolar energy to coagulate tissue ([0033]) . Regarding claim 9, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 1, wherein the side surface of the spatula-like distal end is used to treat tissue with ultrasonic energy to coagulate tissue ([0033]) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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 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. 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. 07-20-02-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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Akagane in view of Messerly et al., US 20210196345, herein referred to as “Messerly” . Regarding claim 2, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 1, but does not explicitly disclose an instrument wherein the ultrasonic transducer is separably activable relative to the source of electrosurgical energy. However, Messerly teaches a combination ultrasonic and electrosurgical surgical instrument wherein the ultrasonic transducer is separably activable relative to the source of electrosurgical energy ([0089]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that the ultrasonic transducer is separably activable relative to the source of electrosurgical energy as taught by Messerly so that the energy is applied based on tissue parameters or other algorithms (Messerly [0002]) . 07-21-aia AIA Claim s 4-5 and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Akagane in view of Akagane, US 20160175000, herein referred to as “Akagane 2” . Regarding claim 4, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 1, but does not explicitly disclose an instrument wherein the electrically conductive material on the elongated edge and the side of the spatula- like distal end are separated by an insulated material and are independently activatable by a switch. However, Akagane 2 teaches a combination ultrasonic and electrosurgical surgical instrument wherein the electrically conductive material on the elongated edge and the side of the spatula- like distal end are separated by an insulated material (Figure 7: main exposed body portion 45 and conductive coating portion 38 are separated by insulation layer portion 37) and are independently activatable by a switch ([0060]) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that the electrically conductive material on the elongated edge and the side of the spatula- like distal end are separated by an insulated material and are independently activatable by a switch as taught by Akagane 2 so that the device can perform a bipolar treatment (Akagane 2 [0062]) . Regarding claim 5, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 4, and Akagane 2 further discloses an instrument wherein an insulating sheath is disposed between the electrically conductive material on the elongated edge and the side of the spatula-like distal end (Figure 7: insulation layer portion 37) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that an insulating sheath is disposed between the electrically conductive material on the elongated edge and the side of the spatula-like distal end as taught by Akagane 2 so that the device can perform a bipolar treatment (Akagane 2 [0062]) . Regarding claim 11, Akagane discloses a combination ultrasonic and electrosurgical surgical instrument (Figure 1) , comprising: a housing (Figure 1: handpiece 12) ; an ultrasonic transducer disposed within the housing (Figure 2: ultrasonic transducer 22) ; and a wave guide (Figure 2: horn member 23) configured to support an ultrasonic blade (Figure 1: probe 17) operably coupled to the ultrasonic transducer ([0024]) , the ultrasonic blade configured to receive ultrasonic energy produced by the ultrasonic transducer ([0022]-[0023]) , the ultrasonic blade tapered along both a vertical and a horizontal axis defined therealong (Figure 3: probe 17 is tapered along the vertical axis and horizontal axis at neck portion 33) and defining an elongated edge on an upper surface (Figure 3: outer peripheral portion 37) thereof terminating at a spatula-like distal end (Figure 3: treatment section 32) , wherein the elongated edge and side of the spatula-like distal end are coated with an electrically conductive material ([0026]: “The probe 17 is formed into a rod of, for example, a biocompatible metallic material (such as titanium alloy). ” and [0028]), the elongated edge and spatula- like distal end adapted to connect to a source of electrosurgical energy ([0033]) such that activation of the electrosurgical energy source treats tissue with both monopolar electrosurgical energy and ultrasonic energy ([0023] and [0026]) . Akagane does not explicitly disclose an instrument wherein the elongated edge and side of the spatula-like distal end are separated by an insulative material, the elongated edge and spatula- like distal end adapted to independently connect to a source of electrosurgical energy. However, Akagane 2 teaches a combination ultrasonic and electrosurgical surgical instrument wherein the elongated edge and side of the spatula-like distal end are separated by an insulative material (Figure 7: main exposed body portion 45 and conductive coating portion 38 are separated by insulation layer portion 37) , the elongated edge and spatula- like distal end adapted to independently connect to a source of electrosurgical energy ([0060]) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that the elongated edge and side of the spatula-like distal end are separated by an insulative material and are adapted to independently connect to a source of electrosurgical energy as taught by Akagane 2 so that the device can perform a bipolar treatment (Akagane 2 [0062]) . Regarding claim 12, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane further discloses an instrument wherein the ultrasonic transducer is adapted to connect to a separate source of electrical energy (Figure 1: ultrasonic current supply section 26 is separate from high-frequency current supply section 28) . Regarding claim 13, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane 2 further discloses an instrument wherein the electrically conductive material on the elongated edge and the side of the spatula- like distal end are independently activatable by a switch ([0060]) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that the electrically conductive material on the elongated edge and the side of the spatula- like distal end are independently activatable by a switch as taught by Akagane 2 so that the device can perform a bipolar treatment (Akagane 2 [0062]) . Regarding claim 14, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane 2 further discloses an instrument wherein the electrically conductive material on the elongated edge and the side of the spatula- like distal end are independently activatable by a switch ([0060]) controlled by an algorithm ([0025]: “The energy control section 18 includes, for example, a central processing unit (CPU) or an application specific integrated circuit (ASIC), and a storage unit, such as a memory.”) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that the electrically conductive material on the elongated edge and the side of the spatula- like distal end are independently activatable by a switch controlled by an algorithm since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner , 120 USPQ 192. Regarding claim 15, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane 2 further discloses an instrument wherein an insulating sheath is disposed between the electrically conductive material on the elongated edge and the side of the spatula-like distal end (Figure 7: insulation layer portion 37) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that an insulating sheath is disposed between the electrically conductive material on the elongated edge and the side of the spatula-like distal end as taught by Akagane 2 so that the device can perform a bipolar treatment (Akagane 2 [0062]) . Regarding claim 16, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane further discloses an instrument wherein both ultrasonic and monopolar energy are simultaneously provided to the elongated edge to quickly and finely dissect tissue ([0026]) . Regarding claim 17, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane further discloses an instrument wherein monopolar energy is provided to the elongated edge to dissect tissue ([0033]) . Regarding claim 18, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane further discloses an instrument wherein the side surface of the spatula-like distal end is used to simultaneously treat tissue with ultrasonic energy and monopolar energy to coagulate tissue ([0033]) . Regarding claim 19, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, and Akagane further discloses an instrument wherein the side surface of the spatula-like distal end is used to treat tissue with ultrasonic energy to coagulate tissue ([0033]) . 07-21-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Akagane in view of Kimball et al., US 20190201041, herein referred to as “Kimball” . Regarding claim 10, Akagane discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 1, but does not explicitly disclose an instrument wherein the waveguide is coated with an insulative material selected from the group consisting of glass, ceramic and polymer. However, Kimball teaches a combination ultrasonic and electrosurgical surgical instrument wherein the waveguide is coated with an insulative material selected from the group consisting of glass, ceramic and polymer ([0496]: “In at least one aspect, the ultrasonic transmission waveguide 137046 may have polymeric material, for example, surrounding it in order to isolate it from outside contact.”) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that the waveguide is coated with an insulative material selected from the group consisting of glass, ceramic and polymer as taught by Kimball in order to isolate the waveguide from outside contact (Kimball [0496]) . 07-21-aia AIA Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Akagane in view of Akagane 2, further in view of Kimball . Regarding claim 20, Akagane in view of Akagane 2 discloses the combination ultrasonic and electrosurgical surgical instrument according to claim 11, but does not explicitly disclose an instrument wherein the wave guide is coated with an insulative material selected from the group consisting of glass, ceramic and polymer. However, Kimball teaches a combination ultrasonic and electrosurgical surgical instrument wherein the waveguide is coated with an insulative material selected from the group consisting of glass, ceramic and polymer ([0496]: “In at least one aspect, the ultrasonic transmission waveguide 137046 may have polymeric material, for example, surrounding it in order to isolate it from outside contact.”) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the combination ultrasonic and electrosurgical surgical instrument disclosed by Akagane so that the waveguide is coated with an insulative material selected from the group consisting of glass, ceramic and polymer as taught by Kimball in order to isolate the waveguide from outside contact (Kimball [0496]) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm 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, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NORA W RHODES/Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794 Application/Control Number: 18/865,571 Page 2 Art Unit: 3794 Application/Control Number: 18/865,571 Page 3 Art Unit: 3794 Application/Control Number: 18/865,571 Page 4 Art Unit: 3794 Application/Control Number: 18/865,571 Page 5 Art Unit: 3794 Application/Control Number: 18/865,571 Page 6 Art Unit: 3794 Application/Control Number: 18/865,571 Page 7 Art Unit: 3794 Application/Control Number: 18/865,571 Page 8 Art Unit: 3794 Application/Control Number: 18/865,571 Page 9 Art Unit: 3794 Application/Control Number: 18/865,571 Page 10 Art Unit: 3794
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