Ex Parte Marcotte et alDownload PDFPatent Trial and Appeal BoardDec 9, 201613442020 (P.T.A.B. Dec. 9, 2016) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/442,020 04/09/2012 Amy L. Marcotte END7055USNP.0590475 1968 100709 7590 12/13/2016 Ethicon Endo-Surgery, Inc. c/o Frost Brown Todd LLC 3300 Great American Tower 301 East Fourth Street Cincinnati, OH 45202 EXAMINER NGUYEN, HIEN NGOC ART UNIT PAPER NUMBER 3777 NOTIFICATION DATE DELIVERY MODE 12/13/2016 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): patents @ fbtlaw. com lgroves@fbtlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AMY L. MARCOTTE, TIMOTHY G. DIETZ, DONNA L. KORVICK, ASHVANI K. MAD AN, and WILLIAM D. DANNAHER Appeal 2014-009305 Application 13/442,020 Technology Center 3700 Before JENNIFER D. BAHR, WILLIAM A. CAPP, and FREDERICK C. LANEY, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Amy L. Marcotte et al. (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1—20. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. Appeal 2014-009305 Application 13/442,020 THE CLAIMED SUBJECT MATTER Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. An apparatus comprising: (a) an instrument body; (b) a shaft assembly extending distally from the instrument body; (c) an end effector disposed at a distal end of the shaft assembly, wherein the end effector is operable to perform a surgical operation at a surgical site, wherein the end effector is further operable to deliver nerve excitation energy to tissue at the surgical site; (d) a control module operable to activate the end effector to deliver nerve excitation energy to the surgical site; and (e) a visual indicator positioned at the distal end of the shaft assembly, wherein the visual indicator is operable to visibly alert a user to indicate a biological response to the nerve excitation energy. REJECTIONS I. Claims 1—13, 16—18, and 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Wiener (US 2011/0015660 Al, pub. Jan. 20, 2011), Costantino (US 2009/0033486 Al, pub. Feb. 2009), Brock (US 2002/0120188 Al, pub. Aug. 29, 2002), and Wagner (US 2004/0204734 Al, pub. Oct. 14, 2004). II. Claims 14, 15, and 19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Wiener, Costantino, Brock, Wagner, and Van Den Biggelaar (US 2008/0039915 Al, pub. Feb. 14, 2008). 2 Appeal 2014-009305 Application 13/442,020 DISCUSSION Rejection I Claims 1—13: Appellants group claims 1—13 together in contesting this rejection. Appeal Br. 15. We select independent claim 1 as representative of this group, and claims 2—13 stand or fall with claim 1. See 37 C.F.R. §41.37(c)(l)(iv). Claim 1 requires, in pertinent part, “a visual indicator positioned at the distal end of the shaft assembly” that “is operable to visibly alert a user to indicate a biological response to the nerve excitation energy.” Appeal Br. 21 (Claims App.). The Examiner finds that Wiener does not disclose delivering nerve excitation energy to the surgical site or a visual indicator as claimed. Ans. 4. The Examiner finds that Costantino and Brock disclose delivering nerve excitation energy to the surgical site and sensors for providing feedback indicative of nerve stimulation, and that Brock discloses monitoring and sensing nerves to prevent nerve damage. Id. at 4—5. The Examiner finds that Wagner teaches a visual indicator at the distal end as claimed. Id. at 5. The examiner determines that it would have been obvious to modify Wiener’s surgical instrument by providing such a visual indicator at the distal end of the shaft, and to deliver nerve excitation energy to the surgical site and feedback as taught by Costantino and Brock, “because this [would] provide visual information to improve surgery and prevent nerve damage.” Id. Appellants do not contest the Examiner’s determination that it would have been obvious to modify Wiener’s instrument as set forth in the rejection. See Appeal Br. 15—16. Rather, Appellants contend that Wagner 3 Appeal 2014-009305 Application 13/442,020 “fails to disclose that the light source (282) is operable to visibly alert a user to indicate a biological response to the nerve excitation energy as recited in claim 1.” Appeal Br. 16. Appellants assert that “[t]his limitation‘tells us’ that the visual indicator must include or be associated with hardware, software, or some other device which senses a biological response to nerve excitation and causes the visual indicator to visibly alert a user.” Reply Br. 7. Appellants’ asserted construction of the limitation in question is consistent with their description of the visual indicator in the Specification. Appellants’ Specification describes “indicator (422),” which is triggered by control board (416), in response to detection of nervous tissue by sensor (420), as being “operable to inform the user that end effector (412) is near, or is touching, nervous tissue.” Spec. 140. The Specification discloses that “indicator (422) may include a selectively illuminated light [or] a color changing light.” Id. Similarly, the Specification describes “an indicator (522)” that is in communication with a “sensor (520)” “such that indicator (522) is activated when sensor (520) detects nervous tissue.” Id. 149. Thus, the visual indicator described in Appellants’ Specification is a visual indicator, such as a selectively illuminated light or a color changing light, which is associated with a sensor so as to be actuated by a signal output by a sensor, either directly or through a control board, upon detection by the sensor of proximity to nervous tissue. As the Examiner explains (Ans. 9), Wagner’s light source is capable of being toggled on and off by a switch (Wagner 137), and, thus, is capable of being toggled on and off by software (or a sensor for detecting a biological response to nerve excitation energy). The actuation of the light 4 Appeal 2014-009305 Application 13/442,020 source indicates to the user whatever the user understands the actuation to mean. Moreover, as the Examiner also points out (Ans. 8—9), Wagner discloses providing the light source with a filter to permit the color of the light to be altered (Wagner 146). Thus, the structure of Wagner’s light source is the same as the structure of the visual indicator (422 or 522) disclosed in Appellants’ Specification. Moreover, the Examiner also explains that Costantino and Brock teach using nerve excitation energy to sense nerve location or proximity and providing feedback to notify the user of nerve tissue. Ans. 9; see Costantino H 21, 22, 48; Brock || 65—70). The Examiner acknowledges that the particular feedback mechanisms of Costantino and Brock do not comprise a visual indicator or light positioned at the distal end of the shaft assembly, as called for in claim 1. Ans. 9. The Examiner determines that it would have been obvious to provide a visual indicator at the distal end of the shaft assembly of Wiener, as taught by Wagner, to provide the feedback information notifying the user of nerve tissue, as taught by Costantino and Brock to “provide visual information to improve surgery and prevent nerve damage.” Id. at 5. Thus, the Examiner’s proposed modification of Wiener yields an arrangement in which a visual indicator positioned at the distal end of the shaft assembly is associated with hardware, software, or some other device which senses a biological response to nerve excitation and causes the visual indicator to visibly alert a user (i.e., “is operable to visibly alert a user to indicate a biological response to the nerve excitation energy,” as called for in claim 1). Appellants contend that there would have been no reason to modify Costantino’s device to place the visual indicator disclosed therein at the 5 Appeal 2014-009305 Application 13/442,020 distal end of the shaft assembly.1 Appeal Br. 16. However, this argument is not responsive to the Examiner’s rejection, which does not propose to modify Costantino’s device. Wagner discloses using the light emanating from light source 282 to illuminate a path of dissection (Wagner 136) and describes the light source as “an optical location indicator provided at the distal end of the dissecting member and adapted to provide a visual indication of a location of the distal end of the dissecting member through the dermus” (Wagner, claim 53). We appreciate that Wagner does not disclose using light source 282 to visibly alert a user to indicate a biological response to the nerve excitation energy. However, Appellants do not identify any flaw in the Examiner’s determination that it would have been obvious, in view of the combined teachings of Wiener, Costantino, Brock, and Wagner, to do so, as a means of providing visual information to improve surgery and prevent nerve damage, as stated by the Examiner (Ans. 5). Presumably, a surgeon will be observing the region around the distal end of the instrument very carefully, and, thus, a visual indicator, such as a change in the color of the illuminating light, at that location would likely be noticed immediately by the surgeon. Thus, the Examiner’s articulated reasoning has rational underpinnings. For the above reasons, Appellants fail to apprise us of error in the rejection of claim 1 as unpatentable over Wiener, Costantino, Brock, and Wagner. Accordingly, we sustain the rejection of claim 1, as well as claims 2—13, which fall with claim 1, under 35 U.S.C. § 103(a) as unpatentable over Wiener, Costantino, Brock, and Wagner. 1 Costantino discloses a display on, for example, a personal computer, on which indicators 106—120 are displayed. Costantino Tflf 46-48; Fig. 2. 6 Appeal 2014-009305 Application 13/442,020 Claims 16—18: Independent claim 16 requires, in pertinent part, a control module “operable to selectively activate the ultrasonic blade to deliver ultrasonic energy to tissue at a surgical site,” “to activate the end effector to deliver nerve excitation energy ... to tissue at the surgical site,” and “to modify the delivery of ultrasonic energy to the tissue at the surgical site based on a biological response to the nerve excitation energy.” Appeal Br. 23—24 (Claims App.). Appellants argue that the combination of Wiener, Costantino, Brock, and Wagner “fails to disclose a control module that is operable to modify the delivery of ultrasonic energy to the tissue at the surgical site based on a biological response to the nerve excitation energy as recited in claim 16.” Appeal Br. 17. The Examiner relies on Costantino’s disclosure in paragraphs 59-67 and Brock’s disclosure in Figure 6, paragraphs 40, 41, 64—71, 89, 90, and 105—108 as satisfying this limitation. Ans. 4—5, 10. These paragraphs of Costantino and Brock cited by the Examiner are directed to sensing when the instrument is close to or approaching a nerve, by monitoring a response to nerve stimulation, and providing feedback, in the form of a visual, tactile, or audible alert, in response to detecting that the instrument is close to or approaching a nerve, to the surgeon, who can react accordingly. The Examiner states that this (particularly the feedback means of Brock) “is similar to modifying the delivery of energy to the device to treat tissue when nerve is detected or when device is near a nerve.” Id. at 10. Thus, as Weiner discloses that “the energy supplied to the cutting/blade device is ultrasonic,” the Examiner determines that “Wiener in view of Brock discloses modifying ultrasonic energy to the blade/cutting device as nerve is 7 Appeal 2014-009305 Application 13/442,020 being detected near the end effector of the blade/cutting device.” Id. at 10-11 (citing Wiener | 7). A control module that sends a visual, tactile, or audible alert that the end effector is approaching nerve tissue to alert the surgeon, who can then modify the delivery of ultrasonic energy to the tissue, is not the same as a control module that modifies the delivery of ultrasonic energy to the tissue based on a biological response to the nerve excitation energy. As already noted above, claim 16 requires a control module “operable to modify the delivery of ultrasonic energy . . . based on a biological response to the nerve excitation energy.” Appeal Br. 23—24 (Claims App.). Thus, claim 16 requires a control module (i.e., a structure in the claimed apparatus) that is operable to modify the delivery of ultrasonic energy based on a biological response to the nerve excitation energy delivered by the end effector under activation by the control module. The Examiner’s reliance on structure in Brock’s or Costantino’s apparatus that is capable of generating and sending a visual, tactile, or audible alert to the surgeon, who may then take action to modify the delivery of ultrasonic energy to the tissue, is insufficient to satisfy the requirement in claim 16 of a control module (i.e., a structure in the claimed apparatus) that is operable to modify the delivery of ultrasonic energy based on a biological response to the nerve excitation energy. For the above reason, the Examiner fails to establish that the subject matter of independent claim 16 would have been obvious. Accordingly, we do not sustain the rejection of claim 16 or claims 17 and 18, which depend from claim 16, under 35 U.S.C. § 103(a) as unpatentable over Wiener, Costantino, Brock, and Wagner. 8 Appeal 2014-009305 Application 13/442,020 Claim 20: Unlike independent claims 1 and 16, which are directed to an apparatus, independent claim 20 is directed to a method. Appeal Br. 21, 23, 24 (Claims App.). Appellants argue that the combination of Wiener, Costantino, Brock, and Wagner “fails to disclose the step of responding to the excitation of nervous tissue by adjusting a surgical function of an end effector as recited in claim 20.” Appeal Br. 19. The Examiner responds that Brock discloses such a step, especially in paragraph 90. Ans. 11 (also citing Brock, Fig. 6; 64—71, 89, and 105—108). According to the Examiner, “Brock discloses feedback to let the user know when a nerve is nearby (the system is inhibited or lessened with further action at the end effector is the effectively same [sic] as adjusting the end effector).” Id. Notably, method claim 20 does not specify who or what performs the step of “responding to the excitation of nervous tissue by adjusting the surgical function.” Appeal Br. 24 (Claims App.). Thus, whether the vibration or force feedback to the handle imparted by Brock’s sensing system “in order to inhibit or lessen further action at the end effector” (Brock 190) is effective itself to adjust a surgical function of the end effector, or whether it merely prompts the surgeon to make such adjustment, Brock teaches responding to the excitation of nervous tissue by adjusting the surgical function. Appellants do not persuasively explain why the disclosure of Brock cited by the Examiner does not teach the “responding” step of claim 20. Appellants present a new argument in the Reply Brief, namely, that Wiener and Costantino “fail to disclose using a single end effector to perform a surgical function on tissue at the surgical site and to excite nervous tissue at or near the surgical site as recited in claim 20” and that 9 Appeal 2014-009305 Application 13/442,020 “[t]he remaining references relied upon by the [Examiner] fail to make up for this deficiency.” Reply Br. 9. This argument is untimely, and Appellants do not present any evidence or explanation to show good cause why it should be considered by the Board at this time. See 37 C.F.R. § 41.41(b)(2) (“Any argument raised in the reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the examiner’s answer . . . will not be considered by the Board for purposes of the present appeal, unless good cause is shown.”). For the above reasons, Appellants do not apprise us of error in the rejection of claim 20. Accordingly, we sustain the rejection of claim 20 under 35 U.S.C. § 103(a) as unpatentable over Wiener, Costantino, Brock, and Wagner. Rejection II In contesting the rejection of claims 14, 15, and 19, Appellants rely solely on their arguments presented in contesting the rejections of claims 1 and 16, adding only that Van Den Biggelaar “fails to make up for this deficiencies [Vc] of Wiener [], Costantino, Brock [], and Wagner.” Appeal Br. 19. Claims 14 and 15: For the reasons discussed above, Appellants’ arguments fail to apprise us of error in the rejection of claim 1. Thus, for the same reasons, these arguments fail to apprise us of error in the rejection of claims 14 and 15, which depend, either directly or indirectly, from claim 1 (Appeal Br. 23 (Claims App.)). Accordingly, we also sustain the rejection of claims 14 and 15 under 35 U.S.C. § 103(a) as unpatentable over Wiener, Costantino, Brock, Wagner, and Van Den Biggelaar. 10 Appeal 2014-009305 Application 13/442,020 Claim 19: Claim 19 depends from claim 16 (Appeal Br. 24 (Claims App.)). The Examiner’s rejection of claim 19 suffers from the same deficiency as the rejection of claim 16. The Examiner’s application of Van Den Biggelaar’s teachings with regard to the use of AC pulse electrical current to stimulate nerve tissue (Ans. 7—8) does not make up for the deficiency in the combination of Wiener, Costantino, Brock, and Wagner vis-a-vis the control module “operable to modify the delivery of ultrasonic energy . . . based on a biological response to the nerve excitation energy” limitation of claim 16. Accordingly, we do not sustain the rejection of claim 19 under 35 U.S.C. § 103(a) as unpatentable over Wiener, Costantino, Brock, Wagner, and Van Den Biggelaar. DECISION The Examiner’s decision rejecting claims 1—20 is affirmed as to claims 1—15 and 20, and is reversed as to claims 16—19. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED-IN-PART 11 Copy with citationCopy as parenthetical citation