Ex Parte Truckai et alDownload PDFPatent Trial and Appeal BoardOct 16, 201713267258 (P.T.A.B. Oct. 16, 2017) 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. 13/267,258 10/06/2011 Csaba Truckai 37646-714.201 8493 21971 7590 10/18/2017 WILSON, SONSINI, GOODRICH & ROSATI 650 PAGE MILL ROAD PALO ALTO, CA 94304-1050 EXAMINER PORTER, JR, GARY A ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 10/18/2017 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): patentdocket @ wsgr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CSABA TRUCKAI and AKOS TOTH1 Appeal 2016-008146 Application 13/267,258 Technology Center 3700 Before DONALD E. ADAMS, RYAN H. FLAX, and DEVON ZASTROW NEWMAN Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to a method for performing endometrial ablation. Claims 20-26 and 28—33 are on appeal as rejected under 35 U.S.C. §§ 102 and 103. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Minerva Surgical, Inc. App. Br. 3. Appeal 2016-008146 Application 13/267,258 STATEMENT OF THE CASE The Specification states, “[t]he present invention relates to electrosurgical methods and devices for global endometrial ablation in a treatment of menorrhagia. More particularly, the present invention relates to applying radio frequency current to endometrial tissue by means of capacitively coupling the current through an expandable, thin-wall dielectric member enclosing an ionized gas.” Spec. 12. Claim 20 is the sole independent claim, is representative, and is reproduced below: 20. A method for performing endometrial ablation comprising: trans-cervically introducing a probe working end into a patient’s uterine cavity, the working end comprising an expandable-contractible frame that carries a compliant energy- delivery surface; actuating the frame to expand the energy-delivery surface in the uterine cavity; actuating an inflation source to further expand the energy- delivery surface in the uterine cavity; and delivering energy from or through the energy-delivery surface to cause endometrial ablation. App. Br. 15 (Claims App’x). The following rejections are on appeal: Claims 20-26 and 30-33 stand rejected under 35 U.S.C. § 102(b) as anticipated by Truckai.2 Final Action 3. 2 US 2002/0022870 A1 (published Feb. 21, 2002) (“Truckai”). 2 Appeal 2016-008146 Application 13/267,258 Claims 26, 28, and 29 stand rejected under 35 U.S.C. § 103(a) over Trackai and Stem.3 Id. at 6. FINDINGS OF FACT We adopt the Examiner’s findings of fact, reasoning on scope and content of the claims and prior art, and conclusions set out in the Final Action and Examiner’s Answer. The findings of fact set forth below are provided to highlight certain evidence. FF1. Tmckai discloses “an apparatus and method of ablating and/or coagulating tissue, such as that of the utems or other organ.” Tmckai 111; see also Final Action 3—5, and Ans. 5—10 (discussing Tmckai). FF2. Tmckai discloses a “First Exemplary Embodiment— Structure,” which is illustrated at, inter alia, Figures 1—10 and 20. Tmckai 12—22, 31, 56—89; see also Final Action 3—5, and Ans. 5—10 (discussing Tmckai). FF3. Tmckai discloses: Electrode carrying means 12 is preferably a sack formed of a material which is non-conductive, which is permeable to moisture and/or which has a tendency to absorb moisture, and which may be compressed to a smaller volume and subsequently released to its natural size upon elimination of compression. Examples of preferred materials for the electrode carrying means include open cell sponge, foam, cotton, fabric, or cotton-like material, or any other material having the desired characteristics. 3 U.S. Patent 6,041,260 (issued Mar. 21, 2000) (“Stem”). 3 Appeal 2016-008146 Application 13/267,258 Truckai 166 (emphasis added); see also Final Action 3—5, and Ans. 5—10 (discussing Truckai). Truckai further discloses, “[ejlectrodes 14 are preferably attached to the outer surface of the electrode carrying means 12, such as by deposition or other attachment mechanism.” Truckai 1 67; see also Final Action 3—5, and Ans. 5—10 (discussing Truckai). FF4. Further to the preceding findings of fact, Truckai’s Figures 5 A, 10, and 20, reproduced below, illustrate structural features of the First Exemplary Embodiment (Fig. 20 is reproduced in relevant portion): Figures 5A (above left), 10 (above center), and 20 (above right) show alternative views of an ablation device having an electrode carrying means 12 mounted to the distal end of a shaft 10, with a sheath 32 thereover, which “facilitates insertion of the apparatus into, and removal of the 4 Appeal 2016-008146 Application 13/267,258 apparatus from, the body organ to be ablated . . . such as into the uterus” and into which the electrode carrying means 12 can be compressed and which, when actuated to move proximally, releases the electrode carrying means 12 and allows it to expand. Truckai 1 57, 79; see also Final Action 3—5, and Ans. 5—10 (discussing Truckai). Figure 5A illustrates “a front elevation view of the applicator head and a portion of the main body of the ablation device of FIG. 2, with the main body shown in cross-section,” including an array of electrodes 14, which is a “compliant energy-delivery surface” as claimed, across an electrode carrying means 12, which is an expandable-contractible frame as claimed, shown as expanded.4 Truckai 16, 57, and 67—68; see also Final Action 3—5, and Ans. 5—10 (discussing Truckai). Figure 10 illustrates “a cross-section view of the RF applicator head and the distal portion of the main body of the apparatus of FIG. 1, showing the configuration of RF applicator head after the sheath [32] has been retracted and the spring members [15, 19] have been released into the fully opened condition,” which shows a way to expand or further expand the frame/electrode carrying means 12. Truckai H 22, 81, 81, and 95; see also Final Action 3—5, and Ans. 5—10 (discussing Truckai). Figure 20 illustrates “a side elevation view, similar to the view of FIG. 2, showing an ablation device according to the present invention 4 Truckai’s “FIG. 2 is a front elevation view of the ablation device of FIG. 1, with the handle shown in cross-section and with the RF applicator head in an open condition” and “FIG. 1 is a front elevation view of a first embodiment of an ablation device according to the present invention, with the handle shown in cross-section and with the RF applicator head in a closed condition.” Truckai ^fl[ 12, 13. Thus, figures purporting to illustrate the device of Figures 1 and/or 2 show properties of the same structure. 5 Appeal 2016-008146 Application 13/267,258 in which the electrode carrying means [12] includes inflatable balloons [52], For purposes of clarity, the electrodes [14] on the electrode carrying means [12] are not shown.” Truckai H 31, 87; see also Final Action 3—5, and Ans. 5—10 (discussing Truckai). This shows another way to expand or further expand the frame/electrode carrying means 12. FF5. Further to the preceding finding of fact, with regard to the structure illustrated by Figure 10, Truckai discloses: Because during use it is most desirable for the electrodes 14 on the surface of the electrode carrying means 12 to be held in contact with the interior surface of the organ to be ablated, the electrode carrying means 12 may be provide to have additional components inside it that add structural integrity to the electrode carrying means when it is deployed within the body. Truckai 1 85 (emphasis added); see also Final Action 3—5, and Ans. 5—10 (discussing Truckai). This paragraph follows a detailed description of the springs 15 and 19 and how they may be actuated to expand the electrode carrying means 12. See Truckai ^fl[ 81—83. Thus, Truckai teaches that the balloons 52, shown as expanding the electrode carrying means in Figure 10, can be an additional component relative to the springs 15 and 19 to hold the electrode carrying means 12 in contact with the uterine tissue to be ablated. DISCUSSION Only those arguments made by Appellants in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). 6 Appeal 2016-008146 Application 13/267,258 Anticipation A patent claim is invalid for anticipation under 35 U.S.C. § 102 when a prior art reference describes “each and every claim limitation and enable[s] one of skill in the art to practice an embodiment of the claimed invention without undue experimentation.” ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340, 1344 (Fed. Cir. 2012) (quoting Am. Calcar, Inc. v. Am. Honda Motor Co., 651 F.3d 1318, 1341 (Fed. Cir. 2011)). “Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). We find, in view of the above-identified precedent and findings of fact, the Examiner has established that claim 20 is anticipated by Truckai. For example, Truckai discloses: a method for performing endometrial ablation (FF1); trans-cervically introducing a probe working end into a patient’s uterine cavity (FF1, FF2), the working end comprising an expandable-contractible frame (FF3) that carries a compliant energy- delivery surface (FF3); actuating the frame to expand the energy-delivery surface in the uterine cavity (FF4); actuating an inflation source to further expand the energy-delivery surface in the uterine cavity (FF4, FF5); and delivering energy from or through the energy-delivery surface to cause endometrial ablation (FF1, FF3). Appellants have not produced evidence showing, or persuasively argued, that the Examiner’s determination is incorrect. We address Appellants’ arguments below. 7 Appeal 2016-008146 Application 13/267,258 Appellants argue that the claimed “method requires both ‘actuating ... [a] ... frame to expand ... [an] ... energy-delivery surface in the uterine cavity’ and ‘actuating an inflation source to further expand the energy- delivery surface in the uterine cavity.’” App. Br. 5. Pursuant to this argument, Appellants contend that it is Truckai’s spring members 15 and 19, and not Truckai’s electrode carrying member 12, that must be considered the reference’s frame. See, e.g., id. at 6, 8. Further to this, Appellants contend the inflatable balloons 52 disclosed by Truckai cannot be used with these spring members 15 and 19, but can only be used as an alternative thereto. Id. at 7—8, 10. Appellants also argue that, even if Truckai’s electrode carrying means 12 can be considered to be a “self-expanding ‘frame,’” it is not actuated by anything other than the balloon inflation in the respective embodiment of the reference. Id. at 10. We do not find these arguments persuasive. First, we find the Examiner’s interpretation of the Truckai disclosure with respect to disclosing a frame as the electrode carrying means 12 to be reasonable. The Specification describes a frame as follows: In a first aspect, the present invention provides systems for endometrial ablation where the systems comprise a shaft with an expandable-contractible frame mounted thereon. A compliant energy-delivery surface is carried by the frame, and the surface defines an interior chamber when expanded by the frame. The frame is configured to engage the surface against an interior wall or other portion of the patient’s uterine cavity when the working end of the shaft is inserted into the cavity and the frame is expanded. The exterior surface carries an electrode in order to delivery energy into the uterine wall for ablation or other therapeutic use. 8 Appeal 2016-008146 Application 13/267,258 Spec. 1 6. This describes a structure within the scope of the claims and like the electrode carrying means 12 of Truckai, which supports that the Examiner’s understanding of Truckai’s structure is reasonable. Truckai teaches that its electrode carrying means 12 expands when released from compression, e.g., by withdrawing a sheath 32. FF3, FF4. This is expansion of the electrode carrying means 12 by actuation. Second, even if one must consider the springs 15 and 19 of Truckai to be its frame, like that of the claimed method, we do not agree with Appellants’ contention that Truckai’s balloons 52 cannot be used with such springs 15 and 19 to further expand the electrode carrying means 12. The balloons 52 are disclosed by Truckai as a potential addition to the structure described therebefore in the reference, which includes the springs 15 and 19. FF4, FF5. Truckai teaches that the purpose of providing such balloons 52 is to include “additional components inside” the electrode carrying means 12, which serve to “add structural integrity to the electrode carrying means when it is deployed within the body” as it is “desirable for the electrode 14 on the surface of the electrode carrying means 12 to be held in contact with the interior surface of the organ to be ablated.” FF5. Thus, once the springs 15 and 19 are expanded to also expand the electrode carrying means 12 inside the uterus, the balloons 52 can be inflated to ensure this desired contact with the uterine tissue for ablation. Id. Therefore, under either the Examiner’s or Appellants’ interpretation, Truckai anticipates claim 20. For these reasons set forth above, we affirm the anticipation rejection. 9 Appeal 2016-008146 Application 13/267,258 Obviousness Appellants do no more than refer to their arguments over Truckai in relation to anticipation, and further state that Stem does not cure the alleged deficiencies of Tmckai with respect to independent claim 20, upon which claims 26, 28, and 29 ultimately depend (see App. Br. 13). Having found no deficiency in Tmckai, as it relates to Appellants’ claim 20, we are not persuaded. Appellants provide no further comment with regard to the combination of Tmckai and Stem as it relates to claims 26, 28, and 29. Therefore, we affirm the obviousness rejection on this record. SUMMARY The rejection under 35 U.S.C. § 102(b) over Tmckai is affirmed. The rejection under 35 U.S.C. § 103(a) over Tmckai and Stem is affirmed TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 10 Copy with citationCopy as parenthetical citation