CTNF 17/992,978 CTNF 96177 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. Response to Amendment This Office action is responsive to the preliminary amendment filed 01/25/2023. Claims 1-14 have been cancelled and claims 21-34 have been newly added. Claims 15-34 are currently pending in the application. 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 (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. 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 15-34 are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al. (US 2012/0078278 A1) in view of Worrell et al. (US 2015/0080876 A1) . Regarding claims 15-18, 20-25, and 28-32 , Bales discloses an ultrasonic surgical instrument (see Fig. 73), comprising: an ultrasonic waveguide (1502) defining an ultrasonic blade (7304) at a distal end portion thereof, the ultrasonic waveguide configured to transmit ultrasonic energy therealong to the ultrasonic blade (see [0210]); a jaw member (7308) pivotable relative to the ultrasonic blade between an open position and a closed position (see [0440]), the jaw member including a structural body (7318) and a jaw liner (7314) retained by the structural body, the jaw liner defining a tissue-contacting surface, wherein, in the closed position, the tissue-contacting surface of the jaw liner and an opposed surface of the ultrasonic blade cooperate to define a grasping area therebetween (in the closed position, tissue is grasped between the jaw liner and the ultrasonic blade, see [0440]). Further regarding claims 18, 23, and 30 , Bales discloses a housing (302, see Fig. 3); and an elongated assembly (304) extending distally from the housing, the elongated assembly supporting an end effector assembly at a distal end portion thereof, the end effector assembly including the ultrasonic blade and the jaw member (waveguide assembly 304 supports jaw member 7308 and blade 7304 at the distal end, see Fig. 73). Further regarding claims 24 and 31 , Bales discloses a transducer (902, see Fig. 55) configured to produce ultrasonic energy for transmission to the ultrasonic blade (the converts electrical input to a physical output that imparts movement to the waveguide and thereby the blade, see [0208]). Bales fails to teach the ultrasonic blade and jaw liner define openings therethrough, the openings disposed within the grasping area and in communication with a lumen defined at least partially through the ultrasonic blade or the jaw liner, the lumen adapted to connect to a source of vacuum to enable aspiration through the opening as claimed in claims 15, 16-17, 21-22, 28 and 29. Bales further fails to teach a vacuum system as claimed in claims 20, 25, and 32. Worrell, in the same field of art, teaches a related ultrasonic surgical instrument (see [0042] and Fig. 8-12), including jaws (2215a, 2215b) having a plurality of openings (2225a-2225j) therethrough at a plurality of spaced-apart longitudinal locations within the grasping area and oriented towards each other (although shown on the outer surface, the ports can be disposed on the inner working surfaces of the jaws 2217a and 2217b see Fig. 9 and [0075]), the openings are in communication with lumens (2223b, 2223c) extending through the jaws (the lumens can be formed internally of the jaws as shown in Fig. 12, see [0078] and [0042]), the lumens each having an open proximal end and closed distal end (see Fig. 9), the lumens are in communication with a shaft lumen (2223a) extending through an elongated member (2210), and the lumens are connected at their proximal ends to a vacuum system configured to establish suction through the lumen and the plurality of openings (the fluid paths may be connected to a pump configured to apply negative pressure which is understood to be a vacuum system, see [0048]). Although Worrell largely shows the fluid control system with respect to two jaws, Worrell discloses that the first and second fluid paths can correspond to first and second sides of an end effector (see [0074]). Worrell also describes the fluid control system may be incorporated into ultrasonic cutting tools having an end effector including a blade (see [0043] and [0044]). It is understood based on the disclosure that the fluid control system can be integrated into a medical device having an end effector comprising an ultrasonic blade and a jaw member as taught by Bales. 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 ultrasonic surgical instrument of Bales so that the ultrasonic blade and jaw liner define openings therethrough, the openings disposed within the grasping area and in communication with a lumen defined at least partially through the ultrasonic blade and the jaw liner and connected to a source of vacuum to enable aspiration, as taught by Worrell, since doing so would aid in suctioning smoke generated by coagulating tissue from the surgical field (see Worrell [0052]). In the ultrasonic surgical instrument of Bales, as modified by Worrell, the ultrasonic blade and jaw liner would each define a plurality of spaced-apart openings oriented towards each other and a lumen in communication with a shaft lumen extending through the elongated assembly. The ultrasonic surgical instrument would further include a vacuum system in communication with the lumens in the ultrasonic blade and jaw liner configured to establish suction through the lumens and the plurality of openings. Regarding claim 19 , Bales further teaches a transducer and generator assembly (303) disposed on or in the housing (see Fig. 3 and [0145]); and a battery assembly (301) disposed on or in the housing (see Fig. 3 and [0145]), wherein the battery assembly is configured to power the transducer and generator assembly to, in turn, produce ultrasonic energy for transmission along the ultrasonic waveguide (the battery pack transmits voltage output to the TAG assembly to power the TAG assembly to generate transducer drive signal, see [0149]). Regarding claims 26 and 33 , the combination of Bales and Worrell teaches the ultrasonic surgical instrument according to claims 25 and 32, wherein the vacuum system is activated in a pre-determined manner relative to activation of the transducer. It is noted that this limitation by a user performing the function manually. A user could activate the activate the vacuum system after activation of the transducer. Regarding claims 27 and 34 , the combination of Bales and Worrell teaches the ultrasonic surgical instrument according to claims 25 and 32, wherein the vacuum system is activated in response to activation of the transducer. It is noted that this limitation could be met by a user performing the function manually. A user could activate the transducer and subsequently activate the vacuum system . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. All of the documents cited in the attached PTO-892 teach related ultrasonic surgical instruments. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm. 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, Elizabeth Houston can be reached at (571)272-7134. 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. 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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. /SERENITY A MILLER/Examiner, Art Unit 3771 /ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771 Application/Control Number: 17/992,978 Page 2 Art Unit: 3771 Application/Control Number: 17/992,978 Page 3 Art Unit: 3771 Application/Control Number: 17/992,978 Page 4 Art Unit: 3771 Application/Control Number: 17/992,978 Page 5 Art Unit: 3771 Application/Control Number: 17/992,978 Page 6 Art Unit: 3771 Application/Control Number: 17/992,978 Page 7 Art Unit: 3771
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