Ex Parte Desinger et alDownload PDFBoard of Patent Appeals and InterferencesMar 27, 201210515945 (B.P.A.I. Mar. 27, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte KAI DESINGER, THOMAS STEIN, ANDRE ROGGAN, and THOMAS PREZEWOVSKY __________ Appeal 2010-009805 Application 10/515,945 Technology Center 3700 __________ Before TONI R. SCHEINER, DEMETRA J. MILLS, and FRANCISCO C. PRATS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to an apparatus that applies high frequency current for thermal sclerosis of body tissue, used for example in tumor removal. The Examiner entered rejections for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2010-009805 Application 10/515,945 2 STATEMENT OF THE CASE In electrosurgical procedures in which tissues, such as liver tumors, are sclerosed, “one or more electrodes are placed in the tissue to be sclerosed, that is to say the tumor tissue, or in the immediate proximity thereof, and an alternating current is caused to flow between the electrodes” (Spec. 1). The electrical resistance of the tissue “causes the alternating current applied by way of the electrodes to be converted into joulean heat. At temperatures of between 50 and 100°C, massive denaturisation of the body-specific proteins (coagulation) occurs and consequently the tissue area in question is caused to die off” (id. at 2). “Tissue impedance depends greatly on the advance of the thermal tissue destruction. With increasing sclerosing of the tissue in particular its ohmic resistance and therewith also impedance rises” (id. at 4). Appellants’ invention is based on the underlying concept that, “in contrast to temperature, tissue impedance represents an item of volume information which integrally describes the tissue properties between the two measurement locations necessary for impedance measurement” (id.). Thus, in Appellants’ invention, “the change in impedance characteristic in combination with a multipolar application arrangement is to be utilised for optimum therapy control” (id.). Accordingly, in one embodiment, Appellants’ invention is directed to an apparatus with an array of electrodes, the device also including a selector device configured such that, prior to the selection of a sub-array of electrodes for energy application, the measuring device implements “a measurement in respect of the impedance or the active resistance of the body tissue between all possible pairs of active electrodes and selects as the sub- Appeal 2010-009805 Application 10/515,945 3 array those active electrodes between which the impedance or the active resistance is at its smallest or does not exceed a predetermined value” (id. at 8). Claims 3 and 5-26 stand rejected and appealed (App. Br. 3). 1 Claim 6 is representative and reads as follows (indentation ours): Claim 6: An application apparatus for applying a high frequency current for thermal sclerosis of body tissue, including a connected electrode array with at least three active electrodes which can be introduced into body tissue, a high frequency generator for producing a high frequency voltage, which generator is to be switchably connected to one or more of the electrodes, and a measuring device for measuring the impedance of the body tissue between all or selected active electrodes, characterised by a selector device which is connected to the measuring device and which is adapted to select a sub-array including at least two active electrodes from the electrode array on the basis of the measured impedance, and by a control device which is connected to the selector device and which is adapted to apply the high frequency voltage to the active electrodes of the selected sub-array in such a way that a high frequency current flows between them through the body tissue, characterized in that the selector device is of such a configuration that prior to the selection or the fresh selection of the sub-array including at least two active electrodes it causes the measuring device to implement a measurement in respect of the impedance or the ohmic resistance of the body tissue between all possible pairs of active electrodes and selects as the sub-array those active electrodes between which the impedance, the ohmic resistance, the change in impedance or the change in ohmic resistance is at its smallest. 1 Appeal Brief entered February 1, 2010. Appeal 2010-009805 Application 10/515,945 4 The following rejections are before us for review: 2 (1) Claims 3, 5-11, and 14-21, under 35 U.S.C. § 102(b) as anticipated by Edwards 3 (Ans. 3-7); (2) Claims 3, 5-11, and 14-27, under 35 U.S.C. § 102(e) as anticipated by Morris 4 (Ans. 7-11); (3) Claims 12 and 13, under 35 U.S.C. § 103(a) as obvious over Edwards and Desai 5 (Ans. 11-12); and (4) Claims 12 and 13, under 35 U.S.C. § 103(a) as obvious over Morris and Desai (Ans. 12-13). DISCUSSION As both anticipation rejections argued by Appellants involve essentially the same issues, we discuss them together. Specifically, Appellants argue that neither Edwards nor Morris describes an apparatus with an electrode sub-array selector device configured to select, for energy application, “those active electrodes between which the impedance, the ohmic resistance, the change in impedance or the change in ohmic resistance is at its smallest” as recited in claim 6 (App. Br. 8, 9). Appellants further argue that neither reference meets the analogously claimed method step recited in the other independent, claim 25 (id.). 2 Appellants erroneously contend that the Examiner did not make an obviousness rejection (see App. Br. 9; see also Final Rejection 10-13 (entered February 10, 2009)). Nonetheless, as seen in our discussion, the outcome in this case is governed by the anticipation rejections. 3 U.S. Patent No. 6,092,528 (issued July 25, 2000). 4 U.S. Patent App. Pub. No. 2002/0120261 A1 (filed August 22, 2001). 5 U.S. Patent No. 5,383,917 (issued January 24, 1995). Appeal 2010-009805 Application 10/515,945 5 The Examiner responds that “[t]here is nothing in the claim language that requires the energy to be delivered only to the electrode pair having the smallest impedance” (Ans. 14). Thus, the Examiner reasons, “[s]ince Edwards teaches selectively delivering energy to all electrodes having an impedance below a maximum value, Edwards must deliver energy to the electrode pair having the smallest impedance value, and may also deliver energy to other electrode pairs having an impedance below the threshold value” (id.). The Examiner finds that the same analysis applies to Morris because “Morris provides a feedback system that monitors tissue impedance and then cuts off power to the electrodes that exceed an impedance threshold (see paragraphs [0128-0129], for example)” (id. at 15). The Examiner urges, therefore, that “Morris clearly teach[es] both the selector device (i.e. controller) for delivering current to the electrodes showing the lowest impedance, and the system would inherently perform this same method” (id.). 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. It is well settled that, to “anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Appeal 2010-009805 Application 10/515,945 6 Also well settled in the law of anticipation is that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added); see also In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (“Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”). Thus, if “the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” Oelrich, 666 F. 2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, while this is arguably a close case, we are not persuaded that a preponderance of the evidence supports the Examiner’s finding that the prior art apparatuses are inherently configured as required by the claims. As Appellants note, claim 6 requires its apparatus to have a selector device configured to select, as the sub-array for energy application, “those active electrodes between which the impedance, the ohmic resistance, the change in impedance or the change in ohmic resistance is at its smallest” (App. Br. 12). The other independent, claim 25, recites a process of thermally sclerosing body tissue, and similarly requires the practitioner to measure impedance between every pair of electrode needles within the array, identify the pair of electrode needles having the lowest impedance between them, and apply current to that pair of electrodes (see id. at 17). Appeal 2010-009805 Application 10/515,945 7 As the Examiner points out, Edwards discloses an electro-sclerosing process in which a multiple electrode sub-array can be selected from a larger array with impedance as a selection criterion (see Edwards, col. 9, 31-49). In contrast to the claims, however, rather than explicitly stating that its energy application is based on a selection of the electrodes having the smallest impedance between them, Edwards’ selection is based on maintaining impedance below a specific threshold: With the use of sensor 346 and feedback control system 84, tissue adjacent to RF electrode 314 can be maintained at a desired temperature for a selected period of time without causing a shut down of the power circuit to electrode 314 due to the development of excessive electrical impedance at electrode 314 or adjacent tissue. (Id. at col. 11, ll. 1-6 (emphasis added).) Similarly, rather than explicitly selecting the sub-array with the lowest impedance, Morris describes maintaining temperature below a threshold level: [O]ne or more sensors 22 can be positioned at the exterior surfaces of electrodes 18, at their distal ends 18de, or intermediate sections. This allows monitoring of temperature, impedance or other tissue property at various points within and outside of the interior of tissue site 5', such that a determination of one or more of the following can be made: (i) the periphery of the selected tissue/tumor mass; (ii) the periphery of the developing ablation volume 5av; and (iii) a determination of when cell necrosis is complete. If at any time, sensor 22 determines that a desired cell necrosis temperature is exceeded, then an appropriate feedback signal is received at power source 20 coupled to energy delivery device 18 which then regulates the amount of electromagnetic energy delivered to electrodes 18 and 18'. Appeal 2010-009805 Application 10/515,945 8 (Morris [0129] (emphasis added).) While we again emphasize that we find this to be a close case, in our view, configuring an apparatus to maintain energy application by selecting a sub-array of electrodes that does not exceed a specified impedance threshold, as in both Edwards and Morris, is significantly different than configuring the device to select the sub-array of electrodes that has the lowest relative impedance between them, as the claims require. In this regard, as noted above, the Specification explicitly distinguishes between the two possible configurations (see Spec. 8 (The apparatus “selects as the sub- array those active electrodes between which the impedance or the active resistance is at its smallest or does not exceed a predetermined value.”)). Given this significant difference in how the prior at describes its sub- array of electrodes as being selected, as compared to how the claims require their sub-array to be selected, we are not persuaded that the prior art devices are necessarily configured such that they would select the sub-array of electrodes required of Appellants’ claims. As noted above, inherency is not demonstrated by possibilities or probabilities. In re Oelrich, 666 F.2d at 581. Thus, we are not persuaded that a preponderance of the evidence supports the Examiner’s position that the prior art devices are inherently configured as required by the claims. We therefore reverse both anticipation rejections. As the Examiner’s obviousness rejections of dependent claims 12 and 13 do not address the shortcomings of Edwards and Morris, discussed above, with respect to independent claim 6, we reverse those rejections as well. Appeal 2010-009805 Application 10/515,945 9 SUMMARY We reverse the Examiner’s anticipation rejection of claims 3, 5-11, and 14-21 over Edwards. We also reverse the Examiner’s anticipation rejection of claims 3, 5- 11, and 14-27 over Morris. We also reverse the Examiner’s obviousness rejection of claims 12 and 13 over Edwards and Desai. We also reverse the Examiner’s obviousness rejection of claims 12 and 13 over Morris and Desai. REVERSED alw Copy with citationCopy as parenthetical citation