CTNF 18/887,931 CTNF 87508 DETAILED ACTION A complete action on the merits of claims 1-13 follows below. 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. 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. 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 AIA Claim s 7-13 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 pre-AIA the applicant regards as the invention. Claim 7 recites the limitation “a selector for selecting whether the first jaw component and the second jaw component are independently movable or coupled”. It is at most unclear what the selector is what is meant by “coupled” and how it selects the first jaw component and the second jaw component are independently movable or coupled. Clarification and appropriate correction is required. Claim 8 recites the limitation “an ultrasonic waveguide”. It is noted that claim 1 functionally recites the limitation “an ultrasonic waveguide”, although claim 8 is now positively claiming an ultrasonic waveguide, it is at most unclear if the two are the same or different. For analysis, they are interpreted to be the same; however, clarification and appropriate correction is required. Claims 9-13 are rejected due to dependency over claim 8. Claim Rejections - 35 USC § 102 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 1-12 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Lesko (US Pub . (US Pub. No. 2017/0164973 ). Regarding Claim 1, Lesko teaches a surgical instrument (Figs. 27 and 52-53), comprising: an end effector assembly, including: a first jaw member bifurcated into a first jaw component and a second jaw component (43,44 / 551,552 / 561,562), the first jaw component and second jaw component defining first and second electrically conductive tissue-contacting surfaces (“clamp pad (41, 42) in the present example is configured with a different polarity so that an RF electrosurgical circuit or pathway is created from clamp pad (41), through captured tissue, to the clamp pad (43), and vice versa” [0147], [0148] / 563, 564 [0198]/ 563,564 [0199]), respectively, wherein the first jaw component is angled relative to the second jaw component (Figs. 27-28, 52- 5); and a second jaw member including an ultrasonic blade body (45 / 555 / 565) adapted to receive ultrasonic energy from an ultrasonic waveguide and adapted to connect to a source of electrosurgical energy ([0147]-[0148] and [0198]-[0199]), wherein the second jaw member defines a first angled tissue-contacting surface, a second angled tissue-contacting surface, and a central tissue-contacting surface (Figs. 27-28 and 52-53), the central tissue-contacting surface defining a substantially flat surface extending between the first and second angled tissue-contacting surfaces (the top center portion of blade 45 in Fig. 27 and the top center section of the blade in Figs. 52-53), wherein the first jaw component and the second jaw component of the first jaw member are movable relative to the second jaw member between a spaced-apart position and an approximated position to grasp tissue therebetween ([0145] and [0195]). Regarding Claim 2, Lesko teaches wherein the first jaw component is generally parallel to the first angled tissue-contacting surface and the second jaw component is generally parallel to the second angled tissue-contacting surface (Fig. 28). Regarding Claim 3, Lesko teaches wherein a clamping force between the first jaw component and the first angled tissue-contacting surface is normal to the first angled tissue-contacting surface (due to the configuration of the jaws and the angled tissue-contacting surface, a clamping force between the first jaw component and the first angled tissue-contacting surface is normal to the first angled tissue-contacting surface, see Fig. 28 for example). Regarding Claim 4, Lesko teaches wherein an angle defined between the first jaw component and the second jaw component is 90 degrees or less (Fig. 28). Regarding Claim 5, Lesko teaches wherein the ultrasonic blade body is generally rectangular with chamfered corners corresponding to the first angled tissue-contacting surface and the second angled tissue-contacting surface (Figs. 52-53). Regarding Claim 6, Lesko teaches wherein the first jaw component and the second jaw component are independently movable (“clamp arms (43, 44) and their associated clamp pads (41, 42) are configured to move either independently or together” in [0146], also see [0198]). Regarding Claim 7, Lesko teaches further comprising a selector for selecting whether the first jaw component and the second jaw component are independently movable or coupled (“clamp arms (43, 44) and their associated clamp pads (41, 42) are configured to move either independently or together” in [0146]). Regarding Claim 8, Lesko teaches further comprising: a housing 122 (Fig. 1); a shaft 130 extending distally from the housing; and an ultrasonic waveguide 112 extending through the shaft, wherein the end effector assembly is supported at a distal end portion of the shaft (Fig. 1 and [0086] and “Blade (160) is positioned at the distal end of an acoustic drivetrain that includes an acoustic waveguide (not shown) and transducer assembly (112)” [0088]). Regarding Claim 9, Lesko teaches further comprising a trigger 128 operably associated with the housing and coupled to the first jaw member, the trigger selectively actuatable to move the first jaw member relative to the second jaw member between the spaced-apart position and the approximated position (Fig. 1 and [0085]). Regarding Claim 10, Lesko teaches further comprising an activation button 125/126 disposed on the housing 122 (Fig. 1), the activation button selectively activatable to supply at least one of electrosurgical energy and ultrasonic energy to the end effector assembly ([0092]). Regarding Claim 11, Lesko teaches further comprising an activation button 125 disposed on the housing, the activation button selectively activatable to supply both electrosurgical energy and ultrasonic energy to the end effector assembly ([0092]). Regarding Claim 12, Lesko teaches wherein the first and second electrically conductive tissue-contacting surfaces are electrically isolated from one another and energizable to different potentials for conducting electrosurgical energy therebetween (“clamp pad (41, 42) in the present example is configured with a different polarity so that an RF electrosurgical circuit or pathway is created from clamp pad (41), through captured tissue, to the clamp pad (43), and vice versa” [0147] and “clamp arm (551, 552) in the present example is provided with a different polarity so that an RF electrosurgical circuit or pathway is created through tissue captured between from clamp arms (551, 552). For instance, clamp arm (551) may have a first electrical polarity while clamp arm (552) may have a second electrical polarity” [0197]) . 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 set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. 07-21-aia AIA Claim s 1-4, 8-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Masuda (US Patent No. 7,905,881 ) in view of Twomey (US Pub. No. 2016/0038220 ) . Regarding Claim 1, Masuda teaches a surgical instrument (Fig. 16), comprising: an end effector assembly, including: a first jaw member 131 bifurcated into a first jaw component and a second jaw component (Fig. 16 and Col. 16, ll. 46-54), the first jaw component and second jaw component defining first and second electrically conductive tissue-contacting surfaces (marked 134 in Fig. 16), respectively (“the inner surfaces of two edge portions of the two parts of the first grasping member 131 located away from each other are configured as first electrodes” Col. 16, ll. 52-54), wherein the first jaw component is angled relative to the second jaw component (Fig. 16); and a second jaw member 135 including an ultrasonic blade body adapted to receive ultrasonic energy from an ultrasonic waveguide (“second grasping member 135 is provided by machining the ultrasonic vibrating portion 31” Col. 16, ll. 55-56) and adapted to connect to a source of electrosurgical energy, wherein the second jaw member 135 defines a first angled tissue-contacting surface, a second angled tissue-contacting surface (a pair of second electrodes 137, Fig. 16), and a central tissue-contacting surface 136, wherein the first jaw component and the second jaw component of the first jaw member are movable relative to the second jaw member between a spaced-apart position and an approximated position to grasp tissue therebetween (Col. 17, ll. 4-15); However, in Fig. 16 the grasping surface 136 appears to be rounded and not the central tissue-contacting surface defining a substantially flat surface extending between the first and second angled tissue-contacting surfaces. In the same field of invention, Twomey teaches “Insulative member 218 defines generally trapezoidal transverse cross-sectional configuration having angled sides 219a, 219b … Angled sides 219a, 219b permit the free end of insulative member 218 to extend partially between jaw components 220a, 220b of jaw member 220 in the first approximated position of end effector assembly 200 without effecting relative movement of jaw components 220a, 220b (the un-actuated condition of end effector assembly 200). However, upon further approximation of jaw members 210, 220, e.g., to the second approximated position, insulative member 218 extends further between jaw components 220a, 220b such that angled sides 219a, 219b urge jaw components 220a, 220b apart from one another” in [0068] and as shown in Fig. 7B. Given the bifurcated jaw component of Masuda, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make section 136 extending between the two parts of the jaw substantially flat top surface in order to better grasp tissue between the two parts of the jaw member upon closing the jaw in order to better effect the electrodes to face each other and supply energy to the grasped tissue therebetween. Regarding Claim 2, Masuda teaches wherein the first jaw component is generally parallel to the first angled tissue-contacting surface and the second jaw component is generally parallel to the second angled tissue-contacting surface (sections 134 and 137 face each other and are generally parallel to one another as seen in Fig. 16, also see Col. 17, ll. 4-16). Regarding Claim 3, Masuda teaches wherein a clamping force between the first jaw component and the first angled tissue-contacting surface is normal to the first angled tissue-contacting surface (sections 134 and 137 face each other and are generally parallel to one another as seen in Fig. 16; thereby the clamping force between the first jaw component and the first angled tissue-contacting surface is normal to the first angled tissue-contacting surface). Regarding Claim 4, Masuda teaches wherein an angle defined between the first jaw component and the second jaw component is 90 degrees or less (as seen in Fig. 16 the angle is about 90 degrees; however, Masuda does not specifically disclose the angle between them; therefore, examiner takes the position that the angle is either 90 degrees as seen in the figure or alternatively it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the angle 90 degrees in order to better supply energy to the grasped tissue therebetween while allowing free movement of the two components with respect to one another as Masuda teaches). Regarding Claim 8, Masuda teaches further comprising: a housing 14 (Figs. 1-3); a shaft 22 extending distally from the housing (Fig. 1); and an ultrasonic waveguide (transducer unit 13 including probe 29, Fig. 1) extending through the shaft (Col. 4, ll. 47-57), wherein the end effector assembly is supported at a distal end portion of the shaft (Figs. 1 with the end-effector of Fig. 16). Regarding Claim 9, Masuda teaches further comprising a trigger 18 operably associated with the housing 14 and coupled to the first jaw member (although the disclosure discusses the handle used to open and close jaw 25, examiner takes the position that the same mechanism is used to open and close the jaw 131 in Fig. 16), the trigger selectively actuatable to move the first jaw member relative to the second jaw member between the spaced-apart position and the approximated position (Col. 8, ll. 14-35). Regarding Claim 13, Lesko teaches wherein the first and second electrically conductive tissue-contacting surfaces are electrically coupled to one another and configured to conduct energy from the first and second electrically conductive tissue-contacting surfaces to the ultrasonic blade body (Col. 16, ll. 64-Col. 17, ll. 24) . 07-21-aia AIA Claim s 5-7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Twomey as applied above and further in view of Lesko (US Pub. No. 2017/0164973 ) . Regarding Claim 5, Masuda in view of Twomey teaches the invention as applied above with the ultrasonic blade body 31 having chamfered corners corresponding to the first angled tissue-contacting surface and the second angled tissue-contacting surface as seen in Fig. 16, but does not teach wherein the ultrasonic blade body is generally rectangular. In the same field of invention, Lesko teaches different cross-sectional shapes associated with the ultrasonic blade such as rectangular (with curved corners) as seen in Figs. 52-53. It would have been an obvious matter of design choice to make the ultrasonic blade 31 of Masuda have a substantial rectangular cross-section with the chamfered corners corresponding to the first angled tissue-contacting surface and the second angled tissue-contacting surface, since applicant has not disclosed that having a rectangular shape solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with triangular shape. Regarding Claim 6, Masuda teaches the invention as applied above, but does not teach wherein the first jaw component and the second jaw component are independently movable. In the same field of invention, Lesko teaches “clamp arms (43, 44) and their associated clamp pads (41, 42) are configured to move either independently or together” in [0146] as shown in Fig. 27. Lesko further teaches “where clamp arms (43, 44) move independently relative to blade (45), either or both clamp arms (43, 44) can be moved to the closed position to compress tissue between the respective clamp pad (41, 42) and blade (45)” [0148]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the two parts of the jaw of Masuda move independently in order to grasp tissue and compress the tissue at the target site between either or both of the sections and the ultrasonic blade as Lesko teaches. Regarding Claim 7, Masuda in view of Lesko teaches further comprising a selector for selecting whether the first jaw component and the second jaw component are independently movable or coupled ([0146]-[0148] of Lesko). Regarding Claim 10, Masuda teaches the invention as applied above and although talks about a pair of first electrodes and a pair of second electrodes and ultrasound vibrations, he is silent in showing the trigger used to activate these components. Lesko teaches further comprising an activation button disposed on the housing (125/126 in Fig. 1 of Lesko), the activation button selectively activatable to supply at least one of electrosurgical energy and ultrasonic energy to the end effector assembly ([0092] of Lesko). Therefore, examiner takes the position that either Masuda also have a similar trigger to activate the energy delivery to the electrodes/ultrasound blade similar to the teachings of Lesko or alternatively it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add similar triggers as disclosed by Lesko in the invention of Masuda in order to allow the user to easily control the delivery of energy. Regarding Claim 11, Masuda in view of Lesko teaches further comprising an activation button (125 in Fig. 1 of Lesko) disposed on the housing, the activation button selectively activatable to supply both electrosurgical energy and ultrasonic energy to the end effector assembly ([0092] of Lesko). Regarding Claim 12, Masuda teaches the invention as applied above and it appears the pair of electrodes associated with the two parts of jaw 131 are coupled together operating in one polarity and not wherein the first and second electrically conductive tissue-contacting surfaces are electrically isolated from one another and energizable to different potentials for conducting electrosurgical energy therebetween as claimed. Lesko teaches “clamp pad (41, 42) in the present example is configured with a different polarity so that an RF electrosurgical circuit or pathway is created from clamp pad (41), through captured tissue, to the clamp pad (43), and vice versa” [0147] and “clamp arm (551, 552) in the present example is provided with a different polarity so that an RF electrosurgical circuit or pathway is created through tissue captured between from clamp arms (551, 552). For instance, clamp arm (551) may have a first electrical polarity while clamp arm (552) may have a second electrical polarity” [0197]. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have electrically independent electrodes on the first jaw 131 in order to allow bipolar energy delivery between the two such that different polarity between the electrodes causes an RF electrosurgical circuit or pathway is created through tissue captured between from clamp arms as Lesko teaches. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 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, Linda Dvorak can be reached on (571) 272-4764. 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. /KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794 Application/Control Number: 18/887,931 Page 2 Art Unit: 3794 Application/Control Number: 18/887,931 Page 3 Art Unit: 3794 Application/Control Number: 18/887,931 Page 4 Art Unit: 3794 Application/Control Number: 18/887,931 Page 5 Art Unit: 3794 Application/Control Number: 18/887,931 Page 6 Art Unit: 3794 Application/Control Number: 18/887,931 Page 7 Art Unit: 3794 Application/Control Number: 18/887,931 Page 8 Art Unit: 3794 Application/Control Number: 18/887,931 Page 9 Art Unit: 3794 Application/Control Number: 18/887,931 Page 10 Art Unit: 3794 Application/Control Number: 18/887,931 Page 11 Art Unit: 3794 Application/Control Number: 18/887,931 Page 12 Art Unit: 3794 Application/Control Number: 18/887,931 Page 13 Art Unit: 3794 Application/Control Number: 18/887,931 Page 14 Art Unit: 3794
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