Ex Parte Barker et alDownload PDFPatent Trial and Appeal BoardJul 19, 201713864030 (P.T.A.B. Jul. 19, 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. BSNC-1-243.1 3931 EXAMINER PLATES KI, ERIN M ART UNIT PAPER NUMBER 3766 MAIL DATE DELIVERY MODE 13/864,030 04/16/2013 50638 7590 07/20/2017 Boston Scientific Neuromodulation Corp. c/o Lowe Graham Jones 701 Fifth Avenue Suite 4800 Seattle, WA 98104 John Michael Barker 07/20/2017 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN MICHAEL BARKER, ANNE MARGARET PIANCA, GEOFFREY ABELL ANA VILLARTA, and MIL AD GIRGIS1 Appeal 2016-003380 Application 13/864,030 Technology Center 3700 Before JOHN G. NEW, RICHARD J. SMITH, and RYAN H. FLAX, 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 stimulation lead. Claims 1—15 and 17—20 are on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse, and we enter a new ground of rejection of claim 14 under 35 U.S.C. § 103(a). 1 Appellants identify the Real Party in Interest as Boston Scientific Neuromodulation Corporation, a wholly-owned subsidiary of Boston Scientific Corporation. App. Br. 2. Appeal 2016-003380 Application 13/864,030 STATEMENT OF THE CASE The Specification states “[t]he present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation leads with arrangements to facilitate lead straightness and compliance.” Spec. 1:8—11. Claims 1 and 14 are the independent claims and are reproduced below: 1. A stimulation lead extending from a proximal end to a distal end, the lead comprising: a plurality of electrodes disposed along the distal end of the lead; a plurality of terminals disposed along the proximal end of the lead; an elongated body separating the plurality of electrodes from the plurality of terminals, the elongated body comprising an outer tube of insulative material, and a cog-shaped conductor guide disposed within, and separate from, the outer tube and extending from the proximal end of the lead to the distal end of the lead, the conductor guide comprising an outer surface, a central core, and a plurality of protrusions extending outward from the central core, wherein the plurality of protrusions and the outer tube define a plurality of pocket regions along the outer surface of the conductor guide with a one of the plurality of pocket regions defined between each pair of adjacent protrusions of the plurality or protrusions; and a plurality of conductors disposed within the plurality of pocket regions with at least one conductor disposed in each of the plurality of pocket regions, each conductor coupling at least one 2 Appeal 2016-003380 Application 13/864,030 of the plurality of electrodes to at least one of the plurality of terminals. 14. A stimulation lead extending from a proximal end to a distal end, the lead comprising: a plurality of electrodes disposed along the distal end of the lead; a plurality of terminals disposed along the proximal end of the lead; an elongated body separating the plurality of electrodes from the plurality of terminals, the elongated body comprising an outer tube of insulative material; a central tube disposed within the outer tube and configured and arranged to receive a stylet, the outer tube and the central tube defining a single lumen between the outer tube and the central tube, and a plurality of independent, individual conductor tubes disposed within the single lumen defined between the central tube and the outer tube, each conductor tube comprising a cylindrical tube material, an outer longitudinal surface of the tube material, a cylindrical lumen disposed within the tube material, and an inner longitudinal surface defining the cylindrical lumen; and a plurality of conductors, each conductor disposed in a different one of the plurality of independent, individual conductor tubes and each conductor coupling at least one of the plurality of electrodes to at least one of the plurality of terminals. App. Br. 19, 21—22 (Claims App’x). 3 Appeal 2016-003380 Application 13/864,030 The following rejections are on appeal: Claims 1—5, 7, and 8 stand rejected under 35 U.S.C. § 103(a) over Gardeski2 and Barker.3 Ans. 3. Claim 6 stands rejected under 35 U.S.C. § 103(a) over Gardeski, Barker, and Soltis.4 Id. at 6. Claim 9 stands rejected under 35 U.S.C. § 103(a) over Gardeski, Barker, and Kaplan.5 Id. at 7. Claim 10 stands rejected under 35 U.S.C. § 103(a) over Gardeski, Barker, and Flowers.6 Id. at 7. Claim 11 stands rejected under 35 U.S.C. § 103(a) over Gardeski, Barker, Soltis, and Baudino.7 Id. at 8. Claim 12 stands rejected under 35 U.S.C. § 103(a) over Gardeski, Barker, Soltis, Baudino, and Olsen.8 Id. at 9. Claim 13 stands rejected under 35 U.S.C. § 103(a) over Gardeski, Barker, Soltis, Baudino, and Flowers. Id. at 10. Claims 14, 15, and 17 stand rejected under 35 U.S.C. § 103(a) over Shoberg,9 Gardeski, and Gallardo.10 Id. at 10. 2 U.S. Pat. App. Pub. No. US 2004/0097965 A1 (May 20, 2004) (“Gardeski”). 3 U.S. Pat. App. Pub. No. US 2009/0198312 A1 (Aug. 6, 2009) (“Barker”). 4 U.S. Pat. App. Pub. No. US 2007/0293922 A1 (Dec. 20, 2007) (“Soltis”). 5 U.S. Pat. App. Pub. No. US 2006/0089691 A1 (Apr. 27, 2006) (“Kaplan”). 6 U.S. Pat. App. Pub. No. US 2009/0222073 A1 (Sept. 3, 2009) (“Flowers”). 7 U.S. Pat. No. 5,865,843 (Feb. 2, 1999) (“Baudino”). 8 U.S. Pat. App. Pub. No. US 2005/0222659 A1 (Oct. 6, 2005) (“Olsen”). 9 U.S. Pat. App. Pub. No. US 2005/0027342 A1 (Feb. 3, 2005) (“Shoberg”). 10 U.S. Pat. App. Pub. No. US 2013/0030426 A1 (Jan. 31, 2013) (“Gallardo”). 4 Appeal 2016-003380 Application 13/864,030 Claim 18 stands rejected under 35 U.S.C. § 103(a) over Shoberg, Gardeski, Gallardo, and Soltis. Id. at 12. Claim 19 stands rejected under 35 U.S.C. § 103(a) over Shoberg, Gardeski, Gallardo, and Kaplan. Id. at 13. Claim 20 stands rejected under 35 U.S.C. § 103(a) over Shoberg, Gardeski, Gallardo, and Flowers. Id. at 13. 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). Claim 1 The Examiner found that Gardeski disclosed the elements of claim 1 except, that “Gardeski does not teach that a one of the plurality of pocket regions is defined between each pair of adjacent protrusions of the plurality of protrusions, or that at least one conductor is disposed in each of the plurality of pocket regions.” Ans. 3^4. The Examiner further found that, based on the structure taught by Barker, it would be obvious to configure the Gardeski structure to have a conductor in each lumen/pocket between each protrusion of Gardeski because it “would work equally well with Gardeski’s teaching of a conductor guide.” Ans. 4—5. Appellants’ argued, inter alia, that Gardeski does not teach an arrangement where a pocket region, as claimed, is provided/defmed between each pair of adjacent protrusions of the cog-shaped conductor guide, and there is a conductor in each such pocket region, because Gardeski discloses a configuration where an outer member’s inward facing projections interlock 5 Appeal 2016-003380 Application 13/864,030 with the outward facing projections of an inner member. App. Br. 9. It is Appellants’ contention that some of the pocket regions defined by adjacent outward protrusions of the inner member are necessarily occupied by the inward facing projections of the outer member such that they cannot hold a conductor as required by claim 1. Id. Further, Appellants argue that it would not have been obvious to omit the inward projections so as to remove the interlocking function of the Gardeski device because it would change the principle of operation of the Gardeski device. Id. Responding to Appellants’ above-identified argument, the Examiner stated that the argument was based on a misunderstanding of the Examiner’s definition of “protrusion” with respect to the Gardeski reference. Ans. 16. The Examiner interpreted Gardeski such that a “protrusion” is a two pronged structure that provides a groove between its prongs, where the inward projection from the outer member resides in that groove for the interlocking feature. Id. (see the Examiner’s annotated Gardeski Figure 1 illustrating this point). Under such an interpretation, the Examiner contends there is a pocket region between each of these two-pronged structures and that it would have been obvious to provide a conductor in each of these spaces so as to satisfy the limitations of claim 1. Id. [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant. 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. 6 Appeal 2016-003380 Application 13/864,030 In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). ‘“It is impermissible within the framework of section 103 to pick and choose from any one reference only so much of it as will support a given position, to the exclusion of other parts necessary to the full appreciation of what such reference fairly suggests to one of ordinary skill in the art.’” In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986) (quoting In re Wesslau, 353 F.2d 238, 241 (CCPA 1965)). “Dependent claims are nonobvious under section 103 if the independent claims from which they depend are nonobvious.” In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988). Based on the above cited precedent, we reverse the rejection of claim 1 over Gardeski. We disagree with the Examiner’s interpretation of Gardeski’s disclosure as explained in the Examiner’s Answer at 16, which serves as a foundation for the obviousness rejection. Gardeski provides no reason to interpret its two outward facing projections (e.g., 18a and 18b) of the inner member (14) that serve to interlock with the inward facing projections (e.g., 16a) of the outer member (13) to be a single projection. The Examiner points to no other evidence supporting such an interpretation. Looking to Figures 1 and 3 of Gardeski, it is apparent that they show an internal cog-shaped structure having 12 outwardly extending projections with a recessed region (called a “lumen,” e.g., 20a—20f, or a “slot,” e.g., 19) between each pair. Gardeski H52—55. While it might be conceivable to include a conductor in each such recessed region, or even to provide such a cog-shaped structure to other lumened devices to internally separate conductors (which is not argued by the Examiner), it would not be obvious to provide a conductor in each recess of Gardeski’s cog-shaped structure 7 Appeal 2016-003380 Application 13/864,030 because doing so would require one to omit the interlocking feature between the inner and outer members of Gardeski. This feature of Gardeski is included in each embodiment and Gardeski indicates that the interlocking splined construction provides very specific advantages (e.g., efficient torque transfer, high flexibility, and high kink-resistance) for its invention. Gardeski | 53. Omitting such a feature would change Gardeski’s fundamental operation. For these reasons, we agree with Appellants that claim 1 would not have been obvious over Gardeski and Barker and we reverse the rejection. Because the Examiner similarly relies on Gardeski as the basis for the rejections of claim l’s dependent claims, we likewise reverse those rejections for the same reasons. Claim 14 In rejecting claim 14, the Examiner cites Shoberg as teaching a stimulation lead having an outer tube of insulative material (outer sheath 25) and a plurality of independent, individual conductor tubes (insulative sheaths 27) with conductors (e.g., 12) within that outer tube. Ans. 11 (citing Shoberg || 13—15, Fig. 2A). The Examiner identifies that Shoberg does not disclose a central tube within the outer tube, configured to receive a stylet, and also defining a single lumen between itself and the outer tube. Ans. 11— 12. For such subject matter, the Examiner combines Gardeski and Gallardo with Shoberg, citing Gardeski’s conductor guide as defining a central lumen (lumen 160) for receiving a stylet and Gallardo’s independent conductor tubes (wires 44a and 44b within compressive coils 105) as disposed in a 8 Appeal 2016-003380 Application 13/864,030 single lumen (tubes 106). Ans. 11—12 (citing Gardeski || 8, 82, Fig. 8; Gallardo H 63, 64, Fig. 4B). Appellants argue Shoberg forecloses having a single lumen defined by an outer and inner tube, that holds a plurality of conductor tubes, because Shoberg teaches that the space inside its outer sheath is filled, specifically, it is filled where the conductors are provided, except where a plurality of lumens are provided for such conductors. Reply Br. 13. We find this argument persuasive. Shoberg does not teach a single lumen defined by a central tube and an outer tube, which houses a plurality of individual conductor tubes. Looking to Shoberg’s Fig. 2A, it is clear that there is no lumen within the outer overlay sheath (25) for holding several conductor tubes and that the multi-lumen tube (20) is not such a lumen, but is instead filled with “an elastomeric biocompatible and biostable insulative material.” Shoberg 113. Gallardo does not remedy Shoberg’s deficiency, as contended by the Examiner, but rather discloses a plurality of lumens for various functions, not a single lumen defined by an outer and inner tube and holding a plurality of conductor tubes. See, e.g., Gallardo 142, Fig. 4C. For these reasons, we agree with Appellants that claim 14 would not have been obvious over Shoberg, Gardeski, and Gallardo and we reverse the rejection. Because the Examiner similarly relies on these references as the basis for the rejections of claim 14’s dependent claims, we likewise reverse those rejections for the same reasons. 9 Appeal 2016-003380 Application 13/864,030 NEW GROUND OF REJECTION Under the provisions of 37 C.F.R. § 41.50(b), we enter the following new ground of rejection: Claim 14 is rejected under 35 U.S.C. § 103(a) as obvious over Kaplan. As the Board’s function is primarily one of review, we leave to the Examiner any further determination as to whether the related dependent claims are also unpatentable in view of our new grounds or otherwise. Findings of Fact We present, as findings of fact, the following claim chart identifying how and where the prior art discloses the elements of claim 14: Claim 14 Prior Art 14. A stimulation lead extending from a proximal end to a distal end, the lead comprising: Kaplan discloses “implantable medical leads,” including cardiac- and neurostimulation leads, extending from a proximal to a distal end. Kaplan Abstract, H 2-4, 30-31, Figs. 1,3, 10. a plurality of electrodes disposed along the distal end of the lead; Kaplan discloses a lead body (33) that carries electrodes (36) at its distal end that function as tissue- stimulating electrodes. Id. H 35, 104, Figs. 1, 10. a plurality of terminals disposed along the proximal end of the lead; Kaplan discloses a lead body (22) that includes electrical contacts (39), i.e., terminals, at its proximal portion (22B) for electrical contact with terminals within an IMD. Id. 1135,104, Figs. 1,10. 10 Appeal 2016-003380 Application 13/864,030 an elongated body separating the plurality of electrodes from the plurality of terminals, the elongated body comprising Kaplan discloses an elongated lead body (33) between its electrodes and terminals. Id. H 35, 104, Figs. 1, 10. an outer tube of insulative material; Kaplan discloses a lead (86) with an insulative, tubular, outer jacket (89), e.g., polyurethane or silicone or alloys thereof. Id. H 42, 69, Figs. 4E, 10. a central tube disposed within the outer tube and configured and arranged to receive a stylet, the outer tube and the central tube defining a single lumen between the outer tube and the central tube, and Kaplan discloses a lead (86) with a tubular stylet guide (88) within the outer jacket (89) and having a coiled wire stylet therein. Id. 1 69, Fig. 4E. Kaplan discloses a single lumen (90) defined by and between the outer jacket (89) and stylet guide (88). Id. a plurality of independent, individual conductor tubes disposed within the single lumen defined between the central tube and the outer tube, each conductor tube comprising a cylindrical tube material, an outer longitudinal surface of the tube material, a cylindrical lumen disposed within the tube material, and an inner longitudinal surface defining the cylindrical lumen; and Kaplan discloses a plurality of conductors as single or braided strands, straight or coiled wires, which teach the “plurality of conductors” element, as discussed below. Id. 59, 69, Figs. 2, 3, 4E. Kaplan discloses that each such conductor is provided within an “insulative outer member,” e.g., polyurethane or silicone included around a coiled wire. Id. 1 83, Figs. 5, 6. Such insulated wires are well known, widely used to prevent shorting between electrical wires, and are, essentially, as old and the technology of electrical circuitry itself. It would have been obvious 11 Appeal 2016-003380 Application 13/864,030 to provide such an insulative outer member as either a tubular coating around a single straight wire (as shown in Kaplan Fig. 4E) or as a tubular sheath around a coiled wire wrapped around a fiber (as shown in Kaplan Fig. 5), thus providing a plurality of independent, individual conductor tubes within the greater lumen, as recited. a plurality of conductors, each conductor disposed in a different one of the plurality of independent, individual conductor tubes and each conductor coupling at least one of the plurality of electrodes to at least one of the plurality of terminals. Kaplan discloses a plurality of conductors (91) “positioned between outer jacket 89 and stylet guide 88,” which are not “anchored within lumen 90 of outer jacket 89,” i.e., they are independent and individual. Id. 1 69, Fig. 4E. Kaplan discloses that its “[conductors 35 connect electrodes 36 to the IMD coupled to the proximal end of lead body 33.” Id. 139, Figs. 1, 4E, 10. Analysis “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v. Adams, 383 U.S. 39, 50-51 (1966). While Kaplan does not expressly disclose a single, specific embodiment simultaneously including each element of independent claim 12 Appeal 2016-003380 Application 13/864,030 14, it certainly teaches and suggests all such claim elements in a single apparatus. As an example, we reproduce Figure 4E of Kaplan below: Kaplan’s Figure 4E shows a lead (86) for, e.g., neurostimulation electrodes, having an insulating outer jacket (89) and a stylet guide (88) therein, defining a lumen (90) therebetween; within the lumen (90) and unanchored between the outer jacket (89) and stylet guide (88) are several conductors (91) for electrodes. Kaplan | 69. All of these features are longitudinally extended to be either tubes, in the case of the outer jacket and stylet guide, or wires, in the case of the conductors. See, e.g., Kaplan Fig. 10. As discussed above in the Findings of Fact, these features, modified to include the tubular insulation around the conductors and the electrodes/terminals on either end of the device, teach and suggest each element of claim 14. Reason to specially modify Kaplan to specifically teach the claimed subject matter can be found within the reference itself, as it discloses all claim elements as useful for the same purpose and to the same end, which is 91 13 Appeal 2016-003380 Application 13/864,030 providing an implantable lead body to accommodate loading forces exerted thereon and, in fact, urges the avoidance of shorting between electrical elements. Kaplan Abstract, || 26, 96. Further, we find that providing a stimulation lead based on the disclosure of Kaplan would be reasonably expected to be successful. Therefore, we find claim 14 would have been obvious over Kaplan. SUMMARY The rejections of claim 1 and its dependent claims under 35 U.S.C. § 103(a) over Gardeski in combination with other prior art are reversed. The rejections of claim 14 and its dependent claims under 35 U.S.C. § 103(a) over Shoberg in combination with other prior art are reversed. We reject claim 14 under 35 U.S.C. § 103(a) as obvious over Kaplan. TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides, “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is 14 Appeal 2016-003380 Application 13/864,030 binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. REVERSED; 37 C.F.R, $ 41.50(b) 15 Copy with citationCopy as parenthetical citation