Ex Parte OlsenDownload PDFPatent Trial and Appeal BoardDec 12, 201411566639 (P.T.A.B. Dec. 12, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JAMES M. OLSEN ____________ Appeal 2012-006598 Application 11/566,639 Technology Center 3700 ____________ Before DONALD E. ADAMS, ULRIKE W. JENKS, and ROBERT A. POLLOCK, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal2 under 35 U.S.C. § 134 involves claims 1, 3–5, 7–11, 13, 14, and 23 (App. Br. 3). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The claims are directed to a method of electrically stimulating the spinal cord. Claim 1 is representative and is reproduced in the Claims Appendix of Appellant’s Brief. 1 The Real Party in Interest is Medtronic, Inc. (App. Br. 3.) 2 This Appeal is related to Appeal Nos: 2012-006646 (Application 11/380,886) and 2012-006687 (Application 11/256,220) (App. Br. 3). Appeal 2012-006598 Application 11/566,639 2 Claims 1, 3–5, 7–11, 14, and 23 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Barreras3 and Tadlock.4 Claim 13 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Barreras, Tadlock, and Van Venrooij.5 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion that the combination of Barreras and Tadlock with or without Van Venrooij suggests a method of electrically stimulating the spinal cord by implanting a plurality of electric stimulation leads in the epidural space of a patient, wherein the third directional stimulation electrode generally faces the spinal cord while the first and second directional stimulation electrodes are orientated at oblique angles relative to the third directional stimulation electrode? FACTUAL FINDINGS (FF) FF 1. Appellant’s Figure 5 is reproduced below: FIG. 5 illustrates a “third active electrode 70 . . . oriented in the direction generally facing the spinal cord 66; and the first and second active electrodes 68 and 72 . . . oriented at oblique angles relative to the third directional stimulation electrode 70” (Spec. ¶ 38). 3 Barreras, Sr. et al., US 5,895,416, issued Apr. 20, 1999. 4 Tadlock, US 2004/0249429 A1, published Dec. 9, 2004. 5 Van Venrooij et al., US 7,212,867 B2, issued May 1, 2007. Appeal 2012-006598 Application 11/566,639 3 FF 2. Barreras “relates to a method and apparatus for electrically and selectively stimulating specific nerve tissue in a living creature . . . by controlling and steering an electric field” (Barreras, col. 1, ll. 7–10). FF 3. Barreras’s Figure 12 is reproduced below: Barreras’ “FIG. 12 is a longitudinal sectional view through the three distal tips of . . . three leads [percutaneously placed within the epidural space proximal to the target vertebrate bodies]. . . and shows three electrical field configurations established therewith” designated as patterns A, B, and C (Barreras, col. 3, ll. 65–67; id. at col. 4, ll. 40–45; Ans. 4–5; Ans. 5 (Barreras’ “electrodes are arranged substantially along a line transverse to the axis of the spinal cord”)). FF 4. Examiner finds that Barreras fails to suggest “stimulation electrodes extending only around a portion of the circumference of the distal end” and relies on Tadlock to make up for this deficiency in Barreras (Ans. 5). FF 5. Tadlock “relates generally to electrical stimulation leads and infusion catheters for medical applications and in particular to a system, method, and resilient neurological stimulation lead for stimulation of a person’s nerve tissue” (Tadlock ¶ 3). FF 6. Examiner finds that “Tadlock employs various electrodes including directional electrodes, which extend only around a portion of the circumference of the lead, in order to emit electrical stimulation energy in a Appeal 2012-006598 Application 11/566,639 4 direction generally perpendicular to the surface of the lead (e.g. Figs. 2E-I) in order to more effectively stimulate nerve tissue” (Ans. 5). FF 7. For clarity, Tadlock’s FIGS. 2E–2I are reproduced below: “FIGS. 2[E]-2I illustrate example electrical stimulation leads that may be used for implantation in or near a person’s brain stem for electrical stimulation of target nerve tissue in the brain stem” (Tadlock ¶ 14). FF 8. Tadlock suggests that The electrodes . . . of a percutaneous lead 14 may be arranged in configurations other than circumferentially . . . such as example leads 14e-i, [which] includes one or more directional electrodes . . . spaced apart from one another along one surface of lead 14. Directional electrodes . . . emit electrical stimulation energy in a direction generally perpendicular to the surface of lead 14 on which they are located. (Tadlock ¶ 50.) FF 9. Examiner finds that the combination of Barreras and Tadlock fails to suggest “shielding which provides electrical insulation over a portion of the electrode while exposing a tissue stimulating portion through a window” and relies on Van Venrooij to make up for this deficiency in the combination of Barreras and Tadlock (Ans. 6). Appeal 2012-006598 Application 11/566,639 5 ANALYSIS The combination of Barreras and Tadlock: Based on the combination of Barreras and Tadlock, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious “to incorporate the design of Tadlock[’s] directional electrodes into the device of Barreras in order to yield the predictable results of providing treatment of the spinal cord effectively with an electrode capable of providing direct stimulation at a site perpendicular to the surface of the lead” (Ans. 5 (emphasis added); see FF 2–8). In addition, Examiner finds that Appellant’s “claims do not require that the term oblique relates to a particular plane” (Ans. 9), and that Barreras’ “electrodes are arranged substantially along a line transverse to the axis of the spinal cord[, as illustrated] in [Barreras’] Fig. 12” (Ans. 5; FF 3). Nevertheless, Examiner reasons that Barreras’ electrodes “are oriented at oblique angles as they are diagonal to the center electrodes – i.e. following the ‘C’ stimulation pattern” set forth in Barreras’s FIG. 12 (Ans. 8–9; Cf. FF 1). We are not persuaded. We recognize the dispute on this record as to whether the combination of Barreras and Tadlock results in electric stimulation leads having a distal end portion wherein the directional stimulation electrode(s) extends only around a portion of the circumference of the generally circular cross section of the distal end portion on which the directional stimulation electrode is dispose (see Ans. 4–6 and 7–8; Cf. App. Br. 8–11; Reply Br. 5–6). Nevertheless, assuming arguendo that Examiner is correct with respect to the foregoing dispute, Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Barreras and Tadlock Appeal 2012-006598 Application 11/566,639 6 suggests a method wherein the third directional stimulation electrode generally faces the spinal cord while the first and second directional stimulation electrodes are orientated at oblique angles relative to the third directional stimulation electrode, as is required by Appellant’s claimed invention. In sum, Examiner appreciates that Barreras’ “electrodes are arranged substantially along a line [(i.e., plane) that is] transverse to the axis of the spinal cord[, as illustrated] in [Barreras’] Fig. 12” (Ans. 5; FF 3). Examiner failed to establish an evidentiary basis on this record to support a conclusion that placing Tadlock’s electrodes, which stimulate a site perpendicular to the surface of lead, in this case perpendicular to Barreras’ transverse plane, will result in Appellants’ claimed arrangement, wherein the first and second directional stimulation electrodes are orientated at oblique angles relative to the third directional stimulation electrode. In addition, Examiner failed to establish an evidentiary basis on this record to support a conclusion that a particular stimulation pattern that may result from Barreras’ device, e.g., pattern “C” requires the electrodes on the stimulation leads to be oriented as is required by Appellant’s claimed invention. As Appellant explains, “Examiner’s interpretation unreasonably ignores the directional aspects of the stimulation electrodes and instead interprets the angular orientation claim limitations as merely referring to the particular layout of the electrodes in a view-from-above perspective, not to the angles of orientation of the directional electrodes . . . relative to the spinal cord” (Reply Br. 8–9; see FF 1; Cf. FF 3). Appeal 2012-006598 Application 11/566,639 7 The combination of Barreras, Tadlock, and Van Venrooij: Based on the combination of Barreras, Tadlock, and Van Venrooij, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious “to incorporate the insulative shielding and windows of Venrooji [sic] into” the device suggested by the combination of Barreras and Tadlock “in order to yield the predictable results of providing electrodes which are capable of directing the current fields more effectively within the epidural space and not stimulating other tissue” (Ans. 6–7). We are not persuaded. Instead, we agree with Appellant’s contention that Examiner failed to establish that Van Venrooij makes up for the foregoing deficiencies in the combination of Barreras and Tadlock (App. Br. 13–14). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to supports a conclusion that the combination of Barreras and Tadlock with or without Van Venrooij suggests a method of electrically stimulating the spinal cord by implanting a plurality of electric stimulation leads in the epidural space of a patient, wherein the third directional stimulation electrode generally faces the spinal cord while the first and second directional stimulation electrodes are orientated at oblique angles relative to the third directional stimulation electrode. The rejection of claims 1, 3–5, 7–11, 14, and 23 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Barreras and Tadlock is reversed. Appeal 2012-006598 Application 11/566,639 8 The rejection of claim 13 under 35 U.S.C. § 103(a) as unpatentable over the combination of Barreras, Tadlock, and Van Venrooij is reversed. REVERSED cdc Copy with citationCopy as parenthetical citation