Ex Parte ChristianDownload PDFPatent Trial and Appeal BoardOct 20, 201611740163 (P.T.A.B. Oct. 20, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111740, 163 0412512007 137540 7590 10/24/2016 Pearl Cohen Zedek Latzer Baratz LLP Given Imaging Ltd. 1500 Broadway, 12th Floor New York, NY 10036 FIRST NAMED INVENTOR Steven C. Christian 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P-71490-US 1619 EXAMINER TOTH, KAREN E ART UNIT PAPER NUMBER 3735 NOTIFICATION DATE DELIVERY MODE 10/24/2016 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): uspto@pearlcohen.com medtronic_mitg-et_docketing@cardinal-ip.com SurgicalUS@covidien.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN C. CHRISTIAN Appeal2013-005924 1 Application 11/740,1632 Technology Center 3700 Before MICHAEL C. ASTORINO, BRUCE T. WIEDER, and MATTHEWS. MEYERS, Administrative Patent Judges. MEYERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's final rejection of claims 1-35. We have jurisdiction under 35 U.S.C. § 6(b). An oral hearing was held on October 17, 2016. We REVERSE. 1 Our decision references Appellant's Appeal Brief ("Appeal Br.," filed October 1, 2012) and Reply Brief ("Reply Br.," filed March 18, 2013), and the Examiner's Answer ("Ans.," mailed January 17, 2013) and Final Office Action ("Final Act.," mailed March 1, 2012). 2 Appellant identifies Given Imaging, Ltd., as the real party in interest (Appeal Br. 1). Appeal2013-005924 Application 11/740,163 CLAIMED INVENTION Appellant's invention relates "to medical devices for monitoring physiological conditions within a body lumen" (Spec. i-f 2). Claims 1, 18, 29, and 33 are the independent claims on appeal. Claim 1, reproduced below with added bracketed notations, is illustrative of the subject matter on appeal: 1. A device comprising: [a] an elongated probe configured to carry an implantable capsule for deployment within a patient; [b] an anchor element configured to anchor the capsule to tissue within the patient; [ c] a vacuum chamber; [ d] a release mechanism configured to release the capsule from the probe; and [ e] an actuator configured to activate the anchor element to cause the anchor element to anchor the capsule to the tissue during a first motion of the actuator, and activate the release mechanism to vent the vacuum chamber and to release the capsule from the probe during a second motion of the actuator. Appeal Br. (Claims. App.). REJECTIONS Claims 1-3, 6, 7, 11, 12, 17-20, 22, 25-31, and33-35 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kilcoyne (US 2004/0158138 Al, pub. Aug. 12, 2004) and Eerdmans (US 2004/0215128 Al, pub. Oct. 28, 2004). Claims 4, 5, 8-10, 21, 23, and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kilcoyne, Eerdmans, and Cros (US 7,621,036 B2, iss. Nov. 24, 2009). 2 Appeal2013-005924 Application 11/740,163 Claims 13 and 14 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kilcoyne, Eerdmans, and Gerber (US 2010/0131016 Al, pub. May 27, 2010). Claims 15, 16, and 32 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kilcoyne, Eerdmans, and Sauer (US 2005/0165419 Al, pub. July 28, 2005). ANALYSIS Independent claim 1 and dependent claims 2, 3, 6, 7, 11, 12, and 17 We are persuaded by Appellant's argument that the Examiner erred in rejecting independent claim 1under35 U.S.C. § 103(a) because the combination of Kilcoyne and Eerdmans fails to disclose or suggest limitation [ e] of independent claim 1 which recites an actuator configured to activate the anchor element to cause the anchor element to anchor the capsule to the tissue during a first motion of the actuator, and activate the release mechanism to vent the vacuum chamber and to release the capsule from the probe during a second motion of the actuator. (See Appeal Br. 4--9; see also Reply Br. 1--4). In rejecting claim 1under35 U.S.C. § 103(a), the Examiner relies on Kilcoyne as disclosing "an actuator configured to activate the anchor element to cause the anchor element to anchor the capsule to the tissue during a first motion of the actuator (element 148), and activates the release mechanism to release the capsule from the probe during a second motion of the actuator" (Final Act. 2 (citing Kilcoyne i-f 104)), but finds that "Kilcoyne does not disclose the second motion of the actuator also venting the vacuum chamber" (Final Act. 2). The Examiner also acknowledges that "Kilcoyne does not provide any details as to how vacuum is controlled during operation of the device" (id.). To address these deficiencies, the Examiner turns to 3 Appeal2013-005924 Application 11/740,163 Eerdmans (id. at 3 ). More particularly, the Examiner relies on Eerdmans as disclosing an actuator (element 44), where movement of the actuator in first and second motions causes anchoring of the capsule of the tissue and release of the capsule from the probe, and movement of the actuator also controls the application of vacuum to the vacuum chamber and overall device, with movement of the actuator controlling alignment of the chamber with a vacuum inlet, and movement of the actuator after anchoring causes the chamber's inlet to be aligned with inlet 34, allowing venting that is inherently necessary to allow the capsule to detach from the probe (see figures 4A-D and 5A-D), in order to precisely control capsule deployment with minimal operator actions. (Id.). Based on the disclosures of Kilcoyne and Eerdmans the Examiner concludes (Id.). [i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the device of Kilcoyne with the actuator configured to also control application of vacuum, as taught by Eerdmans, in order to allow precise control with minimal operator actions. However, we agree with Appellant that the cited portions of Eerdmans, in combination with Kilcoyne, fail to disclose or suggest "an actuator configured to ... activate the release mechanism to vent the vacuum chamber and to release the capsule from the probe during a second motion of the actuator," as recited in limitation [ e] of independent claim 1 (see Appeal Br. 6-9; see also Reply Br. 1--4). In making this determination, we note that Kilcoyne is directed to a "to an implantable probe for monitoring one or more parameters in the esophagus" (Kilcoyne i-f 2). Kilcoyne discloses that its device includes "a housing, a concavity on the housing, and a pin which is axially movable 4 Appeal2013-005924 Application 11/740,163 from a retracted position within the housing to an extended position which extends at least part way across the concavity" (id. i-f 18). Kilcoyne further discloses "a vacuum lumen in communication with the concavity, and the drawing tissue into the concavity step additionally comprises the step of applying suction to the lumen" (id. i-f 17). Kilcoyne also discloses that "[f]ollowing deployment of the pin 164 . .. , the proximal control 186 is manipulated to proximally retract the sleeve 184, thereby opening collet 168 to release the docking structure 126" (id. i-f 104). Eerdmans is directed to a delivery device which "includes a handle and a flexible probe that extends from the handle into the esophagus of the patient," and a capsule which "is coupled to a distal end of the probe for delivery to a particular location within the esophagus" (id. i-f 9). Eerdmans discloses that its delivery device includes a vacuum inlet on the handle to couple the delivery device to a vacuum. The vacuum applies suction \'l1ithin an inner lumen formed by the probe. ii~ vacuum outlet at the distal end of the probe and, more particularly, at the interface between the probe and the capsule, applies suction from the vacuum to the wall of the esophagus in order to draw esophageal tissue of the wall into a void within the capsule. The delivery device anchors the capsule to the esophageal tissue drawn into the void of the capsule and disengages from the capsule thereby leaving the capsule attached to the wall of the esophagus. The delivery device may, for example, advance a locking pin through the esophageal tissue captured in the void to anchor the capsule to the wall of the esophagus. (Id. i-f 11 ). Eerdmans delivery device includes a"[ c ]ontroller 44 [which] may comprise a plunger that is successively pushed through different stages to perform sequential operations during the delivery of capsule 18 to the 5 Appeal2013-005924 Application 11/740,163 appropriate location along esophagus 14" (id. if 35). Eerdmans further discloses that "controller 44 can be adjusted to cause a shaft 48 to advance a locking pin (not shown) through the esophageal tissue within void 46 in order to anchor sensing capsule 18 to a wall of esophagus 14" (id. if 39). Eerdmans also discloses that [p ]lunger 56 is advanced another stage further, in tum contacting and advancing shaft 48 to drive a locking pin or other anchor mechanism through the esophageal tissue in void 46 of capsule 18 in order to anchor capsule 18 to esophagus 14 (FIG. 4(D)). Delivery device 22 may then be removed from esophagus 14 of patient 12. (Id. if 48). In response to Appellant's arguments (see Appeal Br. 4--9), the Examiner states Eerdmans clearly teaches a first actuator motion to anchor the tissue (forward motion of element 48 - figures 4A-D and 5A-C) and a second actuator motion that vents the vacuum and allows release of the capsule (figure 5D; which shows retraction; and figures 4A-D which, taken in reverse, show opening of the vacuum port as part of capsule release). (Ans. 22). The difficulty with the Examiner response, as Appellant points out, is "Eerdmans is silent with respect to the relationship between venting and the detachment of the capsule, and the relationship between the movement of plunger 56 (the actuator) and the detachment of the capsule" (Reply Br. 2). In this regard, Eerdmans discloses that "[p ]lunger 56 is advanced another stage further, in tum contacting and advancing shaft 48" (Eerdmans if 48)), and as such, we agree with Appellant that because "the plunger is not apparently attached to the shaft 48 it is not clear how the shaft is retracted" (id.). Thus, we find the Examiner's statement that 6 Appeal2013-005924 Application 11/740,163 Figure 5D does not have a corresponding illustration in figure 4 to show the position of the components in the handle during retraction of element 48 (the second actuator motion); however, retraction of element 48 would merely be a reversal of the stages shown in figures 4A-D. Figure 5D clearly shows that element 48 is retracted as part of release. As such, when reversing the stages, port 34 would be opened, thereby allowing release of the vacuum (Ans. 21) to be based on speculation unsupported by the Eerdmans' disclosure. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) ("The Patent Office has the initial duty of supplying the factual basis for its rejection. It may not, because it may doubt that the invention is patentable, resort to speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies in its factual basis."). The Examiner further reasons [i]n order to function, the c-shaped portion of the distal end of element 26 which surrounds the probe (unlabeled in figures SA- D) must be airtight, since any leakage of the vacuum would make it difficult, if not impossible, to create enough vacuum to break element 42 and draw tissue into chamber 46. However, if the vacuum is not released, the components would be held in place and the delivery device would not be able to be removed. (Id. at 22). However, as Appellant points out, "[i]n the configurations shown in figures 4(A) and 5(A) no vacuum is applied" (Reply Br. 2) to retain the capsule 18 in the distal end of probe 26 while introducing the probe into the patient (see Eerdmans i-f 45), and thus, "[s]ome other mechanism, not described, retains the capsule with respect to the probe" (Reply Br. 2). We also note that Eerdmans simply discloses that "[t]he capsule is coupled to a distal end of the probe for delivery to a particular location within the esophagus" (Eerdmans i-f 9; see also id. i-f 2). Therefore, in the absence of any evidence and/or technical reasoning to the contrary, we 7 Appeal2013-005924 Application 11/740,163 agree with Appellant that because "neither the vacuum nor the shaft 48 is responsible for retaining the capsule with respect to the probe" (Reply Br. 2) during placement, "[a]ny argument that allowing venting through actuator movement is inherently necessary to allow the capsule to detach is baseless, as there are any number of ways (all undescribed) that detachment could be achieved in Eerdmans" (id. at 2-3). We note the Examiner does not rely on Kilcoyne to cure this deficiency. In view of the foregoing, we do not sustain the Examiner's rejection of independent claim 1under35 U.S.C. § 103(a) as unpatentable over Kilcoyne and Eerdmans. For the same reasons, we also do not sustain the Examiner's rejection of dependent claims 2, 3, 6, 7, 11, 12, and 17 which depend from independent claim 1. Independent claims 18, 29, and 33, and dependent claims 19, 20, 22, 25-28, 30, 31, and 33-35 Independent claims 18, 29, and 33 include a limitation substantially similar to independent claim 1 's limitation [ e] discussed above. Therefore, we do not sustain the Examiner's rejection under 35 U.S.C. § 103(a) of independent claims 18, 29, and 33, and claims 19, 20, 22, 25-28, 30, 31, and 33-35 that depend therefrom, for the same reasons set forth above with respect to independent claim 1. Dependent claims 4, 5, 8-10, 13-16, 21, 23, 24, and 32 Claims 4, 5, 8-10, 13-16, 21, 23, 24, and 32 depend, directly or indirectly, from one of independent claims 1, 18, and 29, and thus, incorporate limitation [ e] recited in independent claim 1 or the similar limitations recited in independent claims 18 and 29. The Examiner's rejections with respect to Cros, in combination with Kilcoyne and Eerdmans, 8 Appeal2013-005924 Application 11/740,163 as applied to claims 4, 5, 8-10, 21, 23, and 24; Gerber, in combination with Kilcoyne and Eerdmans, as applied to claims 13 and 14; and Sauer, in combination with Kilcoyne and Eerdmans, as applied to claims 15, 16, and 32, do not cure the above-discussed shortcomings of Kilcoyne and Eerdmans identified by Appellant. Thus, we do not sustain the Examiner's rejections of dependent claims 4, 5, 8-10, 13-16, 21, 23, 24, and 32 under 35 U.S.C. § 103(a) for the same reasons set forth above with respect to independent claim 1. DECISION The Examiner's rejections of claims 1-35 under 35 U.S.C. § 103(a) are not sustained. REVERSED 9 Copy with citationCopy as parenthetical citation