Ex Parte Young et alDownload PDFPatent Trial and Appeal BoardSep 27, 201210971373 (P.T.A.B. Sep. 27, 2012) 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. 10/971,373 10/22/2004 Kimbolt Young 28-7036822001 (03-473) 7016 23410 7590 09/27/2012 Vista IP Law Group LLP 2040 MAIN STREET, Suite 710 IRVINE, CA 92614 EXAMINER PEFFLEY, MICHAEL F ART UNIT PAPER NUMBER 3739 MAIL DATE DELIVERY MODE 09/27/2012 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 KIMBOLT YOUNG, STEVE M. ANDERSON, PAUL DICARLO, and JEFFREY W. ZERFAS ____________ Appeal 2010-003060 Application 10/971,373 Technology Center 3700 ____________ Before GAY ANN SPAHN, MICHAEL C. ASTORINO, and WILLIAM A. CAPP, Administrative Patent Judges. SPAHN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Kimbolt Young et al. (Appellants) seek our review under 35 U.S.C. § 134 of the Examiner’s final rejection of claims 1-9 and 11-33 under 35 U.S.C. § 103(a) as unpatentable over Behl (US 2004/0158239 A1, published Aug. 12, 2004) and Mahvi (US 2002/0022864 A1, published Feb. 21, 2002). Appeal 2010-003060 Application 10/971,373 2 Appellants cancelled claims 10 and 34-55. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. The Claimed Subject Matter The claimed subject matter “relates to an electrosurgical system having pairs of electrode arrays, which are deployed to treat large volumes of tissue, particularly for the treatment of tumors in the liver and other tissues and organs.” Spec. 1, para. [0001]. Claims 1, 9, 20, and 29 are independent and claim 1, reproduced below, with emphasis added, is illustrative of the subject matter on appeal. 1. A bipolar tissue ablation probe for creating a lesion within a target tissue comprising: a proximal electrode array configured for moving from a retracted configuration to a deployed configuration by proximal retraction; a distal electrode array configured for moving from a retracted configuration to a deployed configuration by distal advancement, wherein proximal and distal electrode arrays have distal termini that are separated from each other by a first length when deployed; a shaft carrying the proximal and distal electrode arrays, wherein the shaft has an electrically insulative portion that separates the proximal and distal electrode arrays, the insulative shaft portion spanning a second length greater than seventy-five percent of the first length; and wherein activation of proximal and distal electrode arrays in a bipolar fashion creates a lesion within the target tissue that necroses from an outer region and progresses inwardly. Appeal 2010-003060 Application 10/971,373 3 OPINION Claims 1-7, 29, and 31-33 Appellants argue claims 1-7, 29, and 31-33 as a group and we select independent claim 1 as the representative claim. See App. Br. 7-10; see also 37 C.F.R. § 41.37(c)(1)(vii) (2011). Claims 2-7, 29, and 31-33 fall with claim 1. The Examiner finds that Behl substantially discloses the subject matter of independent claim 1 (Ans. 3 (citing to Behl’s Fig. 51 embodiment)) including, inter alia, “a ‘non-conductive gap’ that is in the range of 0.25 to 0.75 of the distance between the electrode arrays” (Ans. 4). Behl discloses that “[p]referably, the distance l2 between the inner termini 17 and 21 of the axial conductors 16 and 20 will be in the range from 0.25 to 0.75 of the distance l1 between the inner termini of the innermost portions of the electrode arrays 24 and 26.” Behl, para. [0051], second to last sentence. Emphasis omitted. In other words, the distance l2 between the stems of the electrode arrays is 25% to 75% of the distance l1 between the tips of the electrodes. See Behl, Fig. 1. Since Appellants acknowledge that proximal and distal conductive tubes 84 and 86 effectively form a proximal and distal electrode stem, respectively (Spec. 27, para. [0058]), the Examiner correctly finds that Behl’s non-conductive gap 88 constitutes the distance l2 between the stems. The Examiner also finds that Behl “fail[s] to disclose an insulative material covering a length of the intervening portion . . . and . . . any specific length (i.e.[,] “greater than 75%”) for the non-conductive gap or any other insulation layer formed in the intervening portion.” Ans. 3. To cure Behl’s 1 Behl’s Figure 5 is identical to Appellants’ Figure 12. Appeal 2010-003060 Application 10/971,373 4 deficiency of not having an insulative material covering a length of the intervening portion, the Examiner turns to Mahvi for its teaching of an electrode device having deployable proximal and distal arrays 22b, 22a with an intervening portion of a support shaft therebetween which “may be provided with an insulation coating to cause heating and necrosis to begin at the array tips” and thus, “control the ablation profile such that necros[i]s starts at the outer region of the array and inherently progress inwardly.” Ans. 3-4 (citing to Mahvi, paras. [0048] and [0049]). The Examiner concludes that it would have been obvious to one of ordinary skill in the art to provide Behl’s electrode array device with an insulation layer over the intervening portion of the support shaft between the electrode arrays as taught by Mahvi in order “to control the ablation profile such that necroses start at the outer periphery of the device and progresses inwardly.” Ans. 4. Appellants first argue that Behl teaches away from an ablation probe that is configured for creating a lesion that necroses from an outer region and progresses inwardly, because Behl teaches to preferentially heat the center of the treated region first prior to the heating and necrosis of the outer portions of the treatment region and further, states that “‘[i]f the outer portions of the treatment region were treated first, it might be more difficult to assure that all portions, and in particular the inner portions, of the treatment region are adequately treated.’” App. Br. 7 (quoting Behl, para. [0053]). Appellants further argue that modifying Behl to include an insulation layer as proposed by the Examiner would render Behl’s device “unsatisfactory for its intended purpose of heating target tissue from the center outward and would change the principle of operation of the Behl . . . device since such an insulation Appeal 2010-003060 Application 10/971,373 5 layer would cause tissue to be heated from the periphery inward rather than from the center outward.” App. Br. 8. Emphasis omitted. We are not persuaded by Appellants’ arguments that Behl teaches away from an ablation probe configured for creating a lesion that necroses from an outer region and progresses inwardly and that modifying Behl to include an insulation layer would render Behl’s device unsatisfactory for its intended purpose or change its principle of operation. First, Appellants define Behl’s intended purpose and principle of operation too narrowly. Instead of “heating target tissue from the center outward” as suggested by Appellants, Behl’s intended purpose is more broadly to treat large tissue regions using pairs of electrode arrays, particularly for the treatment of tumors in the liver and other organs. Behl, Abstract and para. [0002]. In addition, Behl’s principle of operation can broadly be defined as delivering radiofrequency energy to treatment regions via the use of ablation probes having electrode arrays regardless of whether the treatment begins at the center and proceeds inwardly or begins at the outer periphery and proceeds outwardly. Second, prior art does not teach away from claimed subject matter merely by disclosing a different solution to a similar problem unless the prior art also criticizes, discredits or otherwise discourages the solution claimed. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Behl simply discloses a preference for heating from the center outward. See Behl, p. 6, para. [0053], (stating “the center of the treated region, e.g., along the axis line 18 between the tips 17 and 21 of the axial conductors 16 and 20, will be preferentially heated prior to the heating and necrosis of the outer Appeal 2010-003060 Application 10/971,373 6 portions of the treatment region.”). Emphasis added. As stated in Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006): [O]bviousness must be determined in light of all the facts, and there is no rule that a single reference that teaches away will mandate a finding of nonobviousness. Likewise, a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine. See [Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n. 8 (Fed. Cir. 2000)] (“The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.”). Where the prior art contains “apparently conflicting” teachings (i.e., where some references teach the combination and others teach away from it) each reference must be considered “for its power to suggest solutions to an artisan of ordinary skill.... consider[ing] the degree to which one reference might accurately discredit another.” In re Young, 927 F.2d 588, 591 (Fed.Cir.1991). Appellants rely upon Behl’s disclosure that it would be more difficult to assure that all portions of the treatment region, particularly the inner portions, were adequately treated if the outer portions of the treatment region were treated first. App. Br. 7 (quoting Behl, para. [0053], last sentence). However, we see this as a mere factor to be weighed, but not one which would nullify the use of Behl as a basis to be modified by the teachings of Mahvi. Although the modification of Behl by the insulated coating 45, 46 of Mahvi may lead to some negative consequences, as suggested by Appellants, other advantages may be gained, such that it would have been obvious to a person having ordinary skill in the art at the time of invention to choose which advantages to pursue given the known tradeoffs stemming Appeal 2010-003060 Application 10/971,373 7 from those choices. Therefore, we find that the Examiner has adequately articulated a reason with rational underpinning for combining Behl and Mahvi because the Examiner's proposed modification of Behl's ablation probe to include an insulated coating as taught by Mahvi would merely be selecting among known designs resulting in known tradeoffs. Appellants next argue that “even if Behl . . . does disclose a length ratio of 75%, claim[] 1 . . . recite[s] that the length ratio is greater than 75%.” App. Br. 8. The Examiner responds to Appellants’ argument by stating that “the upper portion (i.e.[,] 0.75) of [Behl’s] range is extremely close to [Appellants’] claimed and disclosed range of ‘greater than 75%’, and would inherently yield a similar result.” Ans. 4-5. The Examiner continues by stating that Behl “at the very least clearly suggests a non-conductive gap that is inherently capable of creating a lesion that would begin at the outer periphery of the electrodes,” and since Appellants have not disclosed “a critical value necessary to create a lesion that begins at the outer periphery,” and “the instant claimed value of ‘greater than 75%’ is essentially the same as ‘up to 75’, at least as the lower portion of the range (e.g.[,] 75.1%), ” the Examiner determines that “[t]here is every expectation that the Behl . . . device would operate in a similar manner if provided with a non-conductive gap that covers 75% of the gap as disclosed.” Ans. 5. To the extent that the claim language of “greater than seventy-five percent” can be construed to encompass a percentage of slightly greater than seventy-five percent, e.g., 75.1% as suggested by the Examiner, then only a minor difference exists between the upper end percentage of 75% disclosed by Behl and the lower end of the claimed “greater than seventy-five percent” Appeal 2010-003060 Application 10/971,373 8 range. Such a minor difference renders the claimed invention prima facie obvious. See In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (citing Haynes Int’l, Inc. v. Jessop Steel Co., 8 F.3d 1573, 1577 n. 3 (Fed. Cir. 1993) (“when the difference between the claimed invention and the prior art is the range or value of a particular variable, then a prima facie rejection is properly established when the difference in range or value is minor”)). “[A] prima facie case of obviousness exists when the claimed range and the prior art range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (citing Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985)). We determine that one of ordinary skill in this art would have expected similar results for a percentage of seventy-five percent (i.e., the uppermost point of the range of 25% to 75% disclosed in Behl) and for a percentage of 75.1% (approximately the lowermost point of Appellants’ claimed range of greater than 75%) as suggested by the Examiner. See Ans. 4-5. Accordingly, we sustain the Examiner’s rejection of independent claim 1, and claims 2-7, 29, and 31-33 which fall therewith, under 35 U.S.C. § 103(a) as unpatentable over Behl and Mahvi. Claims 9, 11-14, 16, 20-24, and 26 Appellants argue claims 9, 11-14, 16, 20-24, and 26 as a group and we select independent claims 9 and 20 as the representative claims. See App. Br. 7-10; see also 37 C.F.R. § 41.37(c)(1)(vii) (2011). Claims 11-14 and 16 fall with claim 9 and claims 21-14 and 26 fall with claim 20. Independent claim 9 is directed to a bipolar tissue ablation probe for creating a lesion within a targeted tissue including, inter alia, “a separate Appeal 2010-003060 Application 10/971,373 9 electrically insulative material covering a length of the electrically conductive proximal region, the electrically conductive distal region, and the non-conductive gap.” App. Br., Clms. App’x. Independent claim 20 is directed to a bipolar tissue ablation probe including, inter alia, “an electrically insulative material covering at least portions of the proximal and distal tubes adjacent to the non-conductive gap.” Id. The Examiner makes the same findings for independent claims 9 and 20 as those discussed supra for claim 1. Ans. 3-4. Appellants present many of the same arguments as those discussed supra with respect to claim 1, e.g., teaching away, unsatisfactory for its intended purpose, and change in principle of operation. App. Br. 7-9. For the same reasons as discussed supra, we are not persuaded by Appellants’ arguments. Appellants also argue that neither Behl nor Mahvi “teach an insulative layer that covers a non-conductive gap” and since Behl “already teaches that the electrode arrays are insulated from each other by the non-conductive gap 88, there is no reason to cover the non-conductive gap with an insulative material.” App. Br. 9. We are not persuaded by Appellants’ argument that neither Behl nor Mahvi teach an insulative layer covering a non-conductive gap, because Appellants’ argument attacks the references individually and do not address a combination of the references. One cannot show nonobviousness by attacking references individually where the rejections are based on a combination of references. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 426 (CCPA 1981). Appellants have failed to address the Examiner’s combination of Behl and Mahvi in Appeal 2010-003060 Application 10/971,373 10 which Behl’s Figure 5 embodiment is modified to include an insulated coating 45, 46 as taught by Mahvi. We are also not persuaded by Appellants’ argument that there is no reason to cover the non-conductive gap with an insulative material, because the Examiner has adequately articulated a reason with a rational underpinning as to why one of ordinary skill in the art would modify Behl by the teachings of Mahvi, namely, in order “to control the ablation profile such that necroses start at the outer periphery of the device and progresses inwardly.” Ans. 4. Appellants have failed to persuasively indicate why the Examiner’s reasoning does not have a rational underpinning. Accordingly, we sustain the Examiner’s rejection of claims 9 and 20, and claims 11-14, 16, 21-24, and 26 which fall therewith, under 35 U.S.C. § 103(a) as unpatentable over Behl and Mahvi. Claims 17 and 27 Similar to the language of claim 1, claims 17 and 27 call for the insulative material to span a second length greater than seventy-five percent of a first length between the distal termini of the proximal and distal electrode arrays when deployed. App. Br., Clms. App’x. Appellants argue with respect to claims 17 and 27 that “even if Behl . . . does disclose a length ratio of 75%, claims . . . 17 and 27 recite[s] that the length ratio is greater than 75%.” App. Br. 8. Emphasis omitted For the same reasons as discussed supra with respect to claim 1, we find that the minor difference between the claim language and Behl renders the claimed subject matter prima facie obvious. Accordingly, we sustain the Examiner’s rejection of claims 17 and 27 under 35 U.S.C. § 103(a) as unpatentable over Behl and Mahvi. Appeal 2010-003060 Application 10/971,373 11 Claims 8, 18, and 28 Claims 8, 18, and 28 call for the second length of the insulative shaft portion to be “equal to or greater than the first length” between the distal termini of the proximal and distal electrode arrays when deployed. App. Br., Clms. App’x. Appellants argue that the Examiner has failed to point to any disclosure in Behl or Mahvi “where the length of the insulative material is equal to or greater than the length that separates the distal termini of the deployed proximal and distal electrode arrays.” App. Br. 10. We disagree with Appellants. The Examiner finds that Behl “disclose[s] the insulated cap may extend up to 75% of the distance between the electrode arrays.” Ans. 3. Thus, the Examiner pointed out that Behl discloses “equal to” 75%. Accordingly, we sustain the Examiner’s rejection of claims 8, 18, and 28 under 35 U.S.C. § 103(a) as unpatentable over Behl and Mahvi. Claims 15 and 25 Claim 15 recites that “the insulative material covers the entirety of the intervening shaft portion.” App. Br., Clms. App’x. Claim 25 recites that “the insulative material covers the entirety of the proximal and distal tubes.” Id. Appellants argue that “[t]he Examiner has failed to point to any disclosure in Behl . . . or Mahvi . . . where an insulative material covers the entirety of the intervening shaft portion or of the proximal and distal tubes.” App. Br. 10-11. Emphasis omitted. Appeal 2010-003060 Application 10/971,373 12 We disagree with Appellants. The Examiner finds that Mahvi “clearly disclose[s] an insulation material that covers the entirety of the space between the electrode arrays.” Ans. 6. Appellants reply that modifying Behl to include such an insulative covering as taught by Mahvi would cause Behl to heat tissue from an outer region inwardly. Reply Br. 4. Appellants argue that Behl teaches away from this and that such a change would cause Behl to be unsatisfactory for its intended purpose and would change the principle of operation of Behl. Id. For the reasons discussed supra with respect to claim 1, we are not persuaded by Appellants’ teaching away, unsatisfactory for intended purpose, and change in principle of operation arguments. Accordingly, we sustain the Examiner’s rejection of claims 15 and 25 under 35 U.S.C. § 103(a) as unpatentable over Behl and Mahvi. Claim 19 Claim 19 recites that “the insulative material is closer to one of the proximal and distal electrode arrays than the other.” App. Br., Clms. App’x. Appellants argue that “[t]he Examiner has failed to point to any disclosure in Behl . . . or Mahvi . . . where the insulative material is closer to one of the proximal and distal electrode arrays than the other.” App. Br. 11. Emphasis omitted. The Examiner responds that “the specific location for the insulative material would be an obvious selection for the skilled artisan,” “[Appellants’ S]pecification fails to provide any criticality or unexpected result associated with the specific location of the insulation material (e.g. closer to one array),” and “the lesion characteristics that would result from variously Appeal 2010-003060 Application 10/971,373 13 located insulation regions . . . would be readily discernible to the skilled artisan.” Ans. 7. More particularly, the Examiner states that “one of ordinary skill in the art would readily recognize the [e]ffects of the insulation region between the electrode arrays of Behl . . . and would be fully capable of creating a desired lesion pattern by modifying the relative length and position of such an insulation region.” Id. As the Examiner has articulated a reason with a rational underpinning why it would have been obvious to a person of ordinary skill in the art to modify the probe of the combination of Behl and Mahvi to have insulative material closer to one of the proximal and distal electrode arrays than the other, we sustain the Examiner’s rejection of claim 19 under 35 U.S.C. § 103(a) as unpatentable over Behl and Mahvi. Claim 30 Claim 30 recites that “substantially all of the electrical energy conveyed between the proximal and distal electrode elements is conveyed between distal termini of the proximal and distal electrode arrays.” App. Br., Clms. App’x. Appellants argue that “[t]he Examiner has failed to point to any disclosure in Behl . . . or Mahvi . . . where substantially all of the electrical energy conveyed between the proximal and distal electrode elements is conveyed between distal termini of the proximal and distal electrode arrays.” App. Br. 12. Emphasis omitted. More particularly, Appellants argue that Behl “teaches the opposite (i.e., that substantially all the electrical energy is conveyed between the proximal and distal electrode stems).” Id. (citing to Behl, paras. [0027], [0028], [0051], and [0053] and Figs. 1A-1C). Appeal 2010-003060 Application 10/971,373 14 The Examiner responds that Mahvi “clearly provides the suggestion that a lesion should be created with a profile having the energy exit the distal tips of the electrode arrays.” Ans. 7. The Examiner further states that since the Behl “device provides substantially the same structure” and Mahvi “provides the teaching of providing the insulation region extending completely between the electrode arrays, the resulting structure is deemed to react in a manner similar to that claimed by [Appellants].” Id. Appellants reply that modifying Behl to include such an insulative covering as taught by Mahvi would cause Behl to heat tissue from an outer region inwardly. Reply Br. 5. Appellants argue that Behl teaches away from this and that such a change would cause Behl to be unsatisfactory for its intended purpose and would change the principle of operation of Behl. Id. For the reasons discussed supra with respect to claim 1, we are not persuaded by Appellants’ teaching away, unsatisfactory for intended purpose, and change in principle of operation arguments. Accordingly, we sustain the Examiner’s rejection of claim 30 under 35 U.S.C. § 103(a) as unpatentable over Behl and Mahvi. DECISION We affirm the Examiner’s decision to reject claims 1-9 and 11-33. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Klh Copy with citationCopy as parenthetical citation