Ex Parte Steinke et alDownload PDFPatent Trial and Appeal BoardJan 31, 201813403920 (P.T.A.B. Jan. 31, 2018) 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. 13/403,920 02/23/2012 Tom A. Steinke 8150BSC0251C1 2576 121974 7590 02/02/2018 K AC VINSKY DAISAK BLUNI PLLC America's Cup Building 50 Doaks Lane Marblehead, MA 01945 EXAMINER PEFFLEY, MICHAEL F ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 02/02/2018 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): bbonneville @ kdbfirm .com docketing @ kdbfrrm. com ndeane @ kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TOM A. STEINKE, CORBETT W. STONE, STEPHEN O. ROSS, BRIAN S. KELLEHER, RAPHAEL M. MICHEL, and DONALD H. KOENIG Appeal 2017-0005781 Application 13/403,920 Technology Center 3700 Before FRANCISCO C. PRATS, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a system for remodeling atherosclerotic tissue in blood vessels. The Examiner entered rejections for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants state that “the real party in interest in this Appeal is Vessix Vascular, Inc.” Appeal Br. 3. Appeal 2017-000578 Application 13/403,920 STATEMENT OF THE CASE Appellants’ invention is directed to catheters that are deployed within blood vessels having atherosclerotic lesions, and which use energized electrodes to remodel the atherosclerotic material. Spec. 114. The Specification explains that atherosclerotic lesions are often on only one side of the afflicted blood vessel, that is, “eccentric relative to an axis of the blood vessel over 50% of the time, possibly in as much as (or even more than) 75% of cases.” Id. 1 68. The devices and methods of Appellants’ invention will often be particularly well suited for directing treatment eccentrically, often in response to circumferential atherosclerotic material detecting or imaging. While the methods and devices described herein allow such eccentric treatments, the devices can also be used for treatment of radially symmetric atherosclerosis by selectively directing energy in a radially symmetric pattern about an axis of the catheter or the like. Id. To achieve eccentric application of ablative energy only to the side of the blood vessel having the atherosclerotic lesion, the device of Appellants’ invention has arrays of electrodes [which] may be axisymmetric, with an eccentric treatment orientation being selected without physically rotating the array by selectively pairing electrodes of the array. A controller couples the power source to the electrode array for selectively energizing an eccentric subset of the electrode array in response to the measured atherosclerotic material. Id. 123. 2 Appeal 2017-000578 Application 13/403,920 Claim 1 illustrates the appealed subject matter and reads as follows: 1. A system for remodeling of tissue about a blood vessel of a patient, the system comprising: an elongate catheter body having a proximal end and a distal end with an axis therebetween for delivery into the blood vessel; a radially expandable structure near the distal end of the catheter body; a plurality of electrodes supported by the expandable structure so as to be urged radially outward and engage a luminal wall of the blood vessel when the expandable structure expands therein; a power source electrically coupled to the electrodes, the power source configured for energizing the electrodes so as to remodel the tissue; and a controller coupling the power source to the electrodes, the controller configured to selectively energize individual electrodes, and to direct energy eccentrically without rotating the electrodes about the axis by selectively energizing a subset of the electrodes. Appeal Br. 13. The following rejections are before us for review:2 (1) Claims 1-6, 9, 11, 13-18, 20, and 21, under 35 U.S.C. § 102(e) as anticipated by Collins3 (Final Action 2-4); and (2) Claim 19, under 35 U.S.C. § 103(a), for obviousness over Collins and Eggers4 (Final Action 4—5). 2 The Examiner maintained a provisional obviousness-type double patenting rejection over copending application 13/671,474. Ans. 2. After the Examiner’s Answer was entered, Appellants filed, and the Office approved, a terminal disclaimer over that application. See “Electronic Terminal Disclaimer — Approved” (entered August 8, 2016). The provisional double patenting rejection is therefore moot. 3 US 6,837,886 B2 (issued Jan. 4, 2005). 3 Appeal 2017-000578 Application 13/403,920 ANTICIPATION Claim 1 The Examiner finds that Collins describes a device having all of the elements recited in claim 1, and notes in particular that Collins’s device includes a controller which is “expressly disclosed as being configured to activate any desired subsets of electrodes, or individual electrodes, in any desired pattern. This would inherently include an eccentric energization of the electrodes/subsets if desired.” Final Action 3 (citing Collins 7:20-40 as disclosing that “the electrodes may be energized in an infinite number of possible combination through the use of a multiplexor or a switch box”). As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In the instant case, Appellants do not persuade us that the Examiner’s prima facie case of anticipation as to claim 1 is not supported by a preponderance of the evidence. Appellants contend that, although Collins discloses that each electrode filament of its device may be controlled individually, individual energization of a filament would not result in asymmetric, i.e. eccentric, application of energy, because Collins’s filaments are helical in shape. Appeal Br. 6; Reply Br. 5. 4 US 5,419,767 (issued May 30, 1995). 4 Appeal 2017-000578 Application 13/403,920 Moreover, Appellants contend, despite the Examiner’s finding that Collins describes energizing individual electrodes in an infinite number of possible combinations, there [is] no evidence that one of ordinary skill in the art would necessarily choose to energize a combination of electrodes, selected from an infinite number of possible combinations, such that energy is directed eccentrically without rotating the electrodes about the axis by selectively energizing a subset of the electrodes as claimed. Appeal Br. 7; Reply Br. 7. The sole issue presented as to claim 1, thus, is whether Collins’s device includes a controller that couples the device’s power source to its electrodes, the controller being configured to selectively energize individual electrodes, and in which the controller directs energy eccentrically, without rotating the electrodes about the axis, by selectively energizing a subset of the electrodes, as recited in the claim. As to the disputed features of claim 1 ’s controller, as the Examiner found, Collins discloses that its device includes a controller in which a “wire runs from each of the [electrode] filaments 34 within catheter shaft 12 and control handle 14 to connector portion 16. A multiplexer or switch box may be connected to the conductors so that each filament 34 may be controlled individually. This function may be incorporated into controller 8.” Collins 7:24—28. Collins discloses further that “[u]sing a switch box or multiplexer to configure the signals being received by filaments 34 or ablation energy sent to filaments 34 results in an infinite number of possible combinations of filaments ... for applying energy during an ablation procedure.” Id. at 5 Appeal 2017-000578 Application 13/403,920 7:33—39. Thus, as required by claim 1, Collins’s controller is configured to selectively energize individual electrodes. Collins further discloses that, in its device, the individually controlled electrode filaments can be divided into distinctly controllable sectors to which energy may be applied depending on the needs of the operator: Temperature sensors can provide a means of temperature control provided the segment of the ablative ring associated with each sensor is independently controllable (e.g., electrically isolated from other regions of the mesh). For example, control can be achieved by dividing the ablative structure into electrically independent sectors, each with a temperature sensor, or alternatively, each with a mechanism to measure impedance in order to facilitate power titration. The ablative structure may be divided into electrically independent sectors so as to provide zone control. The provision of such sectors can be used to provide power control to various sections of braided conductive member 28. As illustrated in FIG. 8, four temperature sensors 70 are provided on braided conductive member 28. As noted previously, since the individual filaments 34 in braided conductive member 28 are insulated from each other, a number of independent sectors may be provided. A sector may include one or more filaments 34. During ablation procedures, energy can be applied to one or more of the filaments 34 in any combination desired depending upon the goals of the ablation procedure. A temperature sensor could be provided on each filament 34 of braided conductive member 28 or shared among one or more filaments. Id. at 8:33—56. As seen in Figure 8 of Collins, the individually controllable conductive members 34 constituting the independently energizable sectors are in distinct portions of the circumference of the device. See id., Fig. 8. Because Collins discloses that, in its device, the individually controlled electrode filaments can be divided into distinctly controllable sectors, to which energy may be individually applied depending on the needs 6 Appeal 2017-000578 Application 13/403,920 of the operator, and because those individually controllable sectors are disclosed as being in distinct circumferential portions of the device, Appellants do not persuade us that Collins fails to describe a controller configured to direct energy eccentrically without rotating the electrodes, as claim 1 requires. Because Appellants, therefore, do not persuade us that the Examiner erred in finding that Collins describes a device having all of the elements of the device recited in claim 1, we affirm the Examiner’s anticipation rejection of claim 1 over Collins. Because they were not argued separately, claims 5, 6, 9, 11, 13-18, 20, and 21, fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). Claim 2 Appellants’ claim 2 recites “[t]he system of claim 1, wherein the electrodes comprise circumferentially and axially offset RF bipolar electrode pairs, and the controller is configured to deliver RF energy with the circumferentially and axially offset bipolar electrode pairs.” Appeal Br. 13. As to claim 2, the Examiner finds that “Figure 6A [of Collins] show[s] circumferentially and axially offset electrodes, and Collins et al fully disclose bipolar pairs of electrodes that may be individually controlled to deliver energy to tissue (col. 16, lines 5-10, for example).” Final Action 3. Appellants contend that “Collins, however, only appears to describe bipolar operation in conjunction with mapping (see, col. 7, lines 54-58 and col. 16, lines 7—11, of Collins), rather than RF energy delivery as claimed.” Appeal Br. 7. In that regard, Appellants contend, “when used in a mapping application in Collins, the controller is used to process signals coming from catheter and to provide these signals to recording device (see, e.g., col. 4, 7 Appeal 2017-000578 Application 13/403,920 lines 22-24, of Collins).” Id. In particular, Appellants contend, “there does not appear to be any teaching or suggestion to configure the controller in Collins to deliver energy in the highly specific manner claimed in claim 2, specifically, to deliver bipolar RF energy with circumferentially and axially offset bipolar electrode pairs.” Reply Br. 7. We again find that the preponderance of the evidence supports the Examiner’s position. As the Examiner found, and as Appellants concede, Collins discloses that its electrodes may be operated using bipolar electrode pairs, as required by claim 2. See Collins 7:54—58 (“Individual control of the electrical signals received from filaments 34 allows catheter 10 to be used for bipolar (differential or between filament) type mapping as well as unipolar (one filament with respect to a reference) type mapping.”); id. at 16:7—11 (“[T]he catheter of the invention may be used to provide high density maps of a tissue region because electrocardiograms may be obtained from individual filaments 34 in braided conductive member 28 in either a bipolar or unipolar mode.”). Although the references to operating in bipolar mode might be in reference to a mapping function, rather than tissue ablation, as the Examiner found, Collins discloses more generally that the configuration of its device “allows each of the filaments 34 to form an isolated electrode, not an electrical contact with any other filament, that may be used for mapping and ablation.” Id. at 6:5—8 (emphasis added). As noted above, moreover, Collins discloses that, “[djuring ablation procedures, energy can be applied to one or more of the filaments 34 in any 8 Appeal 2017-000578 Application 13/403,920 combination desired depending upon the goals of the ablation procedure.” Id. at 8:51—54. Thus, because Collins’s device is configured to deliver energy to one or more electrodes, including bipolar electrode pairs, in any desired combination, and because Collins’s electrodes may be used both for mapping and ablation, Appellants do not persuade us that the Examiner erred in finding that Collins’s device is configured to deliver energy in the manner required by claim 2. We, therefore, affirm the Examiner’s anticipation rejection of claim 2 over Collins. Claim 3 Appellants’ claim 3 recites “[t]he system of claim 2, wherein the controller couples the power source to the electrodes so that each bipolar electrode pair comprises a circumferentially adjacent pair of electrodes.” Appeal Br. 13. The Examiner finds that Collins’s controller is configured to deliver energy as required by claim 3 because “the controller (8) couples the power source to all the electrodes to allow for the mapping and ablation of tissue with any desired combination of electrodes (col. 6, lines 11-42, for example).” Final Action 3. Appellants contend that, because Collins’s controller is configured to apply energy to an infinite number of possible combinations of electrodes, which “constitute[s] a genus with a very large number of species (including an infinite number of species),” Collins does not describe a controller configured as required in claim 3. Appeal Br. 8; Reply Br. 8—9. We again find that the preponderance of the evidence supports the Examiner’s position. 9 Appeal 2017-000578 Application 13/403,920 As discussed above, Collins’s device is configured to apply energy to bipolar pairs of electrodes in the manner required by claim 2. As required by claim 3, which depends from claim 2, Collins’s device is configured to apply energy independently to distinct sectors, including sectors which are circumferentially adjacent to each other, as also discussed above. See Collins 8:33—56; id. at Fig. 8. Appellants do not persuade us, therefore, that the Examiner erred in finding that Collins’s controller is configured as required by claim 3. We note, moreover, that Appellants’ claims are directed to apparatuses, rather than methods. Thus, that a practitioner, when operating Collins’s device, might not necessarily select the application of energy required by claim 3, does undercut the fact that, as discussed above, Collins’s device is configured to apply energy to any combination of electrodes desired (see id. at 8:51—54), including the combination recited in claim 3. In sum, because Appellants do not persuade us, for the reasons discussed, that the Examiner erred in finding that Collins’s device is configured to deliver energy in the manner required by claim 3, we affirm the Examiner’s anticipation rejection of claim 3 over Collins. Claim 4 Appellants’ claim 4 recites “[t]he system of claim 2, wherein the bipolar electrode pairs alternate between axially and circumferentially offset electrodes.” Appeal Br. 14. The Examiner finds that Collins’s controller is configured to deliver energy as required by claim 4 because “the controller (8) couples the power source to all the electrodes to allow for the mapping and ablation of tissue 10 Appeal 2017-000578 Application 13/403,920 with any desired combination of electrodes (col. 6, lines 11-42, for example).” Final Action 3. Similar to claim 3, Appellants contend that, because Collins’s controller is configured to apply energy to an infinite number of possible combinations of electrodes, this teaching “is so broad as to not constitute any teaching at all, and there does not appear to be any teaching or suggestion in Collins of a controller configured to deliver RF energy with bipolar electrode pairs that alternate between axially and circumferentially offset electrodes as claimed in claim 4.” Appeal Br. 9; Reply Br. 9-10. We again find that the preponderance of the evidence supports the Examiner’s position. As discussed above, Collins’s device is configured to apply energy to bipolar pairs of electrodes in the manner required by claim 2. As to claim 4, which depends from claim 2, Collins’s device is configured to apply energy independently to distinct sectors, including sectors which are circumferentially adjacent to each other, as discussed above, and which are axially offset. See Collins 8:33—56; id. at Fig. 8. When applying energy to the different electrode sectors, moreover, Collins’s device is configured to apply energy to any combination of electrodes desired. See id. at 8:51—54. Appellants do not persuade us, therefore, that the Examiner erred in finding that Collins’s controller is configured as required by claim 4. We again note that Appellants’ claims are directed to apparatuses, rather than methods. Thus, that a practitioner, when operating Collins’s device, might not necessarily select the application of energy required by claim 4, does undercut the fact that, as discussed above, Collins’s device is configured to 11 Appeal 2017-000578 Application 13/403,920 apply energy to any combination of electrodes desired (see id. at 8:51—54), including the combination recited in claim 4. In sum, because Appellants do not persuade us, for the reasons discussed, that the Examiner erred in finding that Collins’s device is configured to deliver energy in the manner required by claim 4, we affirm the Examiner’s anticipation rejection of claim 4 over Collins. OBVIOUSNESS In rejecting claim 19, which depends from claim 1, over Collins and Eggers, the Examiner cited Eggers as evidence that it would have been obvious to modify Collins’s device to direct RF energy to differing electrodes according to a duty cycle, as required by claim 19. Final Action 4-5. Appellants contend only that Eggers does not remedy the deficiencies of Collins with respect to claim 1, discussed above. As discussed above, Appellants do not persuade us that Collins fails to describe a device having all of the elements required by claim 1. Because Appellants, therefore, do not identify, nor do we discern, error in the Examiner’s prima face case of obviousness as to claim 19, we affirm the Examiner’s rejection of claim 19 over Collins and Eggers. SUMMARY For the reasons discussed, we affirm the Examiner’s rejection of claims 1—6, 9, 11, 13—18, 20, and 21, under 35 U.S.C. § 102(e) as anticipated by Collins. For the reasons discussed, we also affirm the Examiner’s rejection of claim 19, under 35 U.S.C. § 103(a), for obviousness over Collins and Eggers (Final Action 4—5). 12 Appeal 2017-000578 Application 13/403,920 TIME PERIOD 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 13 Copy with citationCopy as parenthetical citation