CTNF 18/825,265 CTNF 97927 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 8-11 and 15 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. Claims 8-11 recite the limitation “the swing member” in multiple instances. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation in all instances will be read as --the swinging member-- as recited in claim 1. In claim 15, the limitations “a second contact surface,” “a second direction,” and “a second regulating surface” render the scope of the claim unclear because a first contact surface, first direction, and first regulating surface are not recited in the claim. For examination purposes, these limitations will be read as a contact surface, a direction, and a regulating surface. 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. 07-21-aia AIA Claim s 1-2, 5-8, 10, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Walberg et al. (US PGPub No. 2011/0184404), hereinafter Walberg, in view of Furnish et al. (US Patent No. 5,827,263), hereinafter Furnish . Regarding claims 1, 5-6, and 14-15, Walberg teaches a treatment tool for treating living tissue (Fig. 1A: electrosurgical device 1) comprising: a shaft (Fig. 1A: shaft 20); and an end effector comprising: a movable jaw that is openable and closable with respect to a gripper member that protrudes from a distal end of the shaft (Figs. 5A-5C: set of jaws 130 and jaw 180; par. 0124: “the second jaw 180 is a two-piece jaw that is pivotable with respect to the shaft”); and a swinging member that is pivotably mounted on the movable jaw (Figs. 5A-5C: distal jaw piece 160; par. 0124: “a distal jaw piece 160 that is pivotable with respect to the proximal piece”), the swinging member being configured to swing about a rotation axis with respect to the movable jaw to grip the living tissue between the swinging member and the gripper member (par. 0043: “a tissue engaging surfaces comprises the substantial entirety of the distal and pivotable piece of the first jaw”). Walberg teaches regulating the swinging of the swing arm in two directions (par. 0042: “the pivotable jaw piece may be configured such that it can pivot around its pivotable connection within an arc having pivotable range that varies between about 2 degrees to about 8 degrees. In particular embodiments, the pivotable jaw piece may be configured such that it can pivot around its pivotable connection within an arc having a pivotable range of about 6 degrees;” examiner interprets configuring a particular pivotable range as regulating the swinging of the swing arm in two directions) but is silent with respect to a specific mechanism for configuring the pivotable range, and does not teach the swinging member including a first contact surface and a second contact surface, the first contact surface being configured to regulate swinging of the swinging member in a first direction when contacting a first regulating surface that is provided on a proximal end side of the movable jaw, the second contact surface being configured to regulate swinging of the swinging member in a second direction when contacting a second regulating surface that is provided on the proximal end side of the movable jaw, the second direction being different from the first direction, wherein the rotation axis (or fulcrum) is positioned on a distal end of a longitudinal direction of the movable jaw with respect to the first contact surface and the second contact surface. However, in a related electrosurgical forceps art, Furnish teaches an open-lever stop and closed-lever stop at the proximal side of a lever that together regulate the swinging motion of the lever in both directions relative to a base (Fig. 3: stops 95 and 97, lever 34, base 20; col 5, lines 57-60: “an open-lever stop 95 and a closed lever stop 97, which define a maximum range of motion for the lever 34”), with corresponding first and second contact regions on the swinging lever (Figs. 3-5: limited angular movement of lever 34, also see annotated Fig. 3). PNG media_image1.png 236 696 media_image1.png Greyscale Annotated Figure 3 To provide the treatment tool of Walberg with opposing stops, as taught by Furnish, for regulating the swinging motion of the pivoting jaw piece, would have been obvious to one skilled in the art for the following reasons: Walberg teaches a prior art surgical treatment tool with a pivoting piece (distal jaw piece) that pivots through a limited range of motion relative to a fixed piece (proximal piece). Furnish teaches a prior art surgical treatment tool with a pivoting piece (lever) that pivots through a limited range of motion relative to a fixed piece (base), the range of motion limited by two opposing stops located on the proximal end of the fixed piece. One of ordinary skill in the art would have recognized that the limiting mechanism of Furnish was applicable to the functionality of Walberg regarding the pivoting piece, namely, that providing two opposing stops and corresponding contact surfaces, as taught by Furnish (Figs. 3-5), would have made it possible to limit the range of pivoting motion, as taught by Walberg (par. 0042: “a pivotable range of about 6 degrees”). In light of these teachings, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the jaw of Walberg to include two opposing stops on the proximal end of the jaw and corresponding contact surfaces on the distal jaw piece as a mechanism to achieve the limited pivoting range of motion for the distal jaw piece as taught by Walberg, since the configuration of stops and contact surfaces is taught by Furnish as a mechanism for limiting the pivoting range of motion for a comparable fixed piece and pivoting piece, and one of ordinary skill in the art could have made such a modification with predictable results. Regarding claim 2, the combination teaches the tool of claim 1 as described previously. Walberg further teaches wherein the gripper member and the swinging member include an electrode configured to treat the living tissue gripped between the gripper member and the swinging member when the living tissue gripped between the gripper member and the swinging member receives a high-frequency electric current (par. 0018: “Embodiment B of the device may be described as having two jaws, a first jaw that is fixed with respect to the shaft and having a fixed electrode tray disposed with in it, and a second jaw that is pivotable with respect to the shaft, and having a pivotable electrode tray with in it” and par. 0037: “In some embodiments, the device includes a single bipolar electrode pair, one electrode in each of the jaws. In these single bipolar pair embodiments, the electrodes are powered by a generator operating on a single radiofrequency channel”). Regarding claims 7-8, the combination teaches the tool of claim 6 as described previously. Walberg further teaches wherein a length of a proximal portion of the movable jaw extending in a proximal direction from the fulcrum to a proximal end of the movable jaw is longer than a length of a distal portion of the movable jaw extending in the proximal direction from a distal end of the movable jaw to the fulcrum; and wherein a length of a proximal portion of the swing member extending in the proximal direction from the fulcrum to a proximal end of the swing member is approximately equal to a length of a distal portion of the swing member extending in the proximal direction from a distal end of the swing member to the fulcrum (see annotated Fig. 5C). PNG media_image2.png 310 498 media_image2.png Greyscale Annotated Figure 5C Regarding claim 10, the combination teaches the tool of claim 1 as described previously. Walberg further teaches wherein the swing member is configured to: swing in the first direction such that a distal end of the swing member moves closer to the gripper member and a proximal end of the swing member moves away from the gripper member, and swing in the second direction such that the distal end of the swing member moves away from the gripper member, and the proximal end of the swing member moves closer to the gripper member (Figs. 5A-5C, 7A-7C; par. 0125: “Other than the variation in the configuration of the jaws as just described, other aspects of embodiments A and B are substantially the same. In particular, the dynamics of the closing of the jaws of Embodiment B are the substantially the same as those of Embodiment A, which are described in detail below, in the context of FIGS. 7A-7E” and par. 0130: “A clockwise rotation or pivoting of pivotable jaw piece 60 (of lower jaw 40) results in its distal end or tip 66 assuming a relatively high profile and its proximal aspect assuming a relatively low profile with respect to proximal jaw piece 50;” par. 0132: “a counter clockwise pivoting of the pivotable piece 60 of lower jaw 40 around pivotable connection 75 such that the distal tip of the pivotable piece has moved downward, and the proximal end of the pivotable piece has moved upward”). Regarding claims 12-13, the combination teaches the tool of claim 1 as described previously. Walberg further teaches wherein the movable jaw is configured to rotate so as to open and close with respect to the gripper member; and wherein the movable jaw is rotatably mounted on the shaft (Figs. 5A-5C; par. 0124: “the second jaw 180 is a two-piece jaw that is pivotable with respect to the shaft;” examiner notes that the movable jaw pivoting with respect to the shaft also opens and closes with respect to the probe, i.e., the lower first jaw 140) . 07-21-aia AIA Claim s 3-4, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Walberg in view of Furnish and further in view of Morisaki (US PGPub No. 2017/0000556) . Regarding claim 3, Walberg in view of Furnish teaches the tool of claim 1 as described previously. The combination does not teach further comprising: an ultrasound transducer configured to generate ultrasound vibration, wherein the probe is configured to vibrate in a longitudinal direction of the shaft due to the ultrasound vibration generated by the ultrasound transducer. However, in an analogous art, Morisaki teaches a surgical device comprising an ultrasound transducer (Fig. 1: transducer unit 11), wherein the probe is configured to vibrate in a longitudinal direction of the shaft due to the ultrasound vibration generated by the ultrasound transducer (Fig. 1 and par. 0036: “The ultrasonic vibration is transmitted along the longitudinal axis C from the proximal direction toward the distal direction in the probe 31”). Walberg teaches an electrosurgical instrument that utilizes high-frequency current. Morisaki teaches the benefits of combining high-frequency current with ultrasound for surgery in that the coagulable property of the treated tissue is improved (par. 0066: “When the ultrasonic vibration is transmitted while gripping the treated target, the treatment section 33 vibrates, and frictional heat is generated between the treatment section 33 and the gripped object. The frictional heat causes the treated target to be cut and to coagulate at the same time. A high-frequency current flows between the probe-side electrode section 36 (the probe-side electrode plane 38) and the jaw-side electrode section 65 (the jaw-side electrode plane 92) via the treated target. Thus, the treated target is denatured, and the coagulable property of the treated target is improved”). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by incorporating ultrasound vibration as taught by Morisaki, in order to improve the coagulable property of the treated tissue, as taught by Morisaki. Regarding claims 4 and 11, Walberg in view of Furnish teaches the tool of claim 1 as described previously. The combination does not teach further comprising a pad member that is provided in the swinging member and has an electrical insulating property, the pad member being configured to contact the gripper member when the movable jaw is closed with respect to the gripper member, or wherein the swing member includes a concave portion that is recessed in a direction away from the gripper member, and a pad member is inserted in the concave portion and is fixed to the swing member. However, Morisaki teaches a swinging member with an electrically insulating pad member (Figs. 5 and 7: pad 66, treatment section 33; par. 0046: “The pad member 66 is made of an insulating material (a non-conductive material)”), the pad member being configured to contact the gripper member when the movable jaw is closed with respect to the gripper member (Fig. 7 and par. 0079: “heat used for treatment is effectively transmitted only to the treated target, such as living tissue, etc., gripped between the jaw-side facing surface 75 (the pad member 66) and the treatment section 33”), and wherein the swing member includes a concave portion that is recessed in a direction away from the gripper member, and a pad member is inserted in the concave portion and is fixed to the swing member (Fig. 7: swing arm 62 with concave portion 65 and pad 66 inserted therein). In light of the teachings of Morisaki, it would have been obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the distal jaw piece of the combined reference by incorporating the pad taught by Morisaki, since Applicant has not disclosed that the pad member solves any stated problem is or is for any particular purpose other than gripping tissue, and it appears that the invention would perform equally as well with the gripping surface disclosed by Walberg. Regarding claim 9, Walberg in view of Furnish teaches the tool of claim 6 as described previously. Walberg teaches wherein the swinging member is pivotably mounted to the movable jaw with the fulcrum (Fig. 9A and par. 0139: “It can be seen that pivotable assembly 75 includes a boss 71 of pivotable jaw piece 60 rotatably disposed in a recess 48 of base jaw piece 50. This is a bilateral arrangement, bosses 71 projecting outward on both sides of pivotable jaw piece 60, and mating recesses 48 on both sides of base jaw piece 50”), but does not teach wherein the fulcrum is a support pin. However, Morisaki teaches a swinging member pivotably mounted to a movable jaw with a support pin as a fulcrum (Fig. 5 and par. 0046: “The swing section 62 is coupled to the supporting section 61 with a couple pin 63 being interposed as a coupling member”). The substitution of one known element (a fulcrum comprising bosses and mating recesses as shown in Walberg) for another (a fulcrum comprising a support pin as shown in Morisaki) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since one of ordinary skill in the art could have carried out the substitution, and the results were predictable, namely, the pivoting piece would have been equally capable of pivoting on either type of fulcrum. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET). 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 C DVORAK can be reached at 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. /LINDA C DVORAK/Primary Examiner, Art Unit 3794 /D.E.L./Examiner, Art Unit 3794 Application/Control Number: 18/825,265 Page 2 Art Unit: 3794 Application/Control Number: 18/825,265 Page 3 Art Unit: 3794 Application/Control Number: 18/825,265 Page 4 Art Unit: 3794 Application/Control Number: 18/825,265 Page 5 Art Unit: 3794 Application/Control Number: 18/825,265 Page 6 Art Unit: 3794 Application/Control Number: 18/825,265 Page 7 Art Unit: 3794 Application/Control Number: 18/825,265 Page 8 Art Unit: 3794 Application/Control Number: 18/825,265 Page 9 Art Unit: 3794 Application/Control Number: 18/825,265 Page 10 Art Unit: 3794 Application/Control Number: 18/825,265 Page 11 Art Unit: 3794
