Ex Parte Podhajsky

Patent Trials and Appeals BoardJun 17, 2019

12839023 - (D) (P.T.A.B. Jun. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/839,023 90039 7590 Covidien LP Attn: IP Legal 5920 Longbow Drive Mail Stop A36 07/19/2010 06/19/2019 Boulder, CO 80301-3299 FIRST NAMED INVENTOR Ronald J. Podhajsky 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 ATTORNEY DOCKET NO. CONFIRMATION NO. H-US-01041 (203-5666) 7409 EXAMINER GOOD, SAMANTHA M ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 06/19/2019 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): rs. patents. two@medtronic.com docket@carterdeluca.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RONALD J. PODHAJSKY 1 Appeal2018-007029 Application 12/839,023 Technology Center 3700 Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. Â§ 134 from the Examiner's decision rejecting claims 1-8 and 11-16. We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. 1 The Appeal Brief lists Covidien LP as the real party in interest. Appeal Br. 1. Appeal2018-007029 Application 12/839,023 CLAIMED SUBJECT MATTER The claims are directed to methods for performing an electrosurgical procedure at a surgical site on a patient. Spec. 5. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for performing an electrosurgical procedure at a surgical site on a patient, the method comprising: continually sensing electrical and physical properties proximate the surgical site by: acquiring data readings of an electrical impedance of tissue with respect to time at the surgical site; identifying portions of the data readings of the electrical impedance of the tissue for minima and maxima; and determining a hydration level and a direction of water motility in the tissue at the surgical site; controlling application of electrosurgical energy to the tissue at the surgical site to vary one or more parameters of energy delivered based on the hydration level and the direction of water motility in the tissue at the surgical site; and terminating application of electrosurgical energy at a first minimum of the electrical impedance of the tissue. Appeal Br. 17 (Claims App.). REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Boveja Wham US 2007/0016274 Al Jan. 18, 2007 US 2007/0173 804 A 1 July 26, 2007 2 Appeal2018-007029 Application 12/839,023 Buysse Odom Irisawa US 2007 /0282320 Al Dec. 6, 2007 US 2008/0015575 Al Jan. 17, 2008 US 2008/0114351 Al May 15, 2008 REJECTIONS I. Claims 1, 2, 4, 11, 13, 14, and 15 are rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Buysse and Boveja. II. Claim 3 is rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Buysse, Boveja, and Odom. III. Claims 5-8 and 12 are rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Buysse, Boveja, and Wham. IV. Claim 16 is rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Buysse, Boveja, Wham, and lrisawa. OPINION Rejection I The Examiner finds that Buysse discloses many of the elements recited in claim 1, including the application of electrosurgical energy to tissue at a surgical site, but relies on Boveja to teach terminating the application of energy at a first minimum of electrical impedance of the tissue. Final Act. 4--5. The Examiner reasons that it would have been obvious to include this process step in the method disclosed by Buysse "in order to protect the patient." Id. at 5 ( citing Boveja ,r 121 ). Appellant argues that Buysse fails to disclose determining water motility of tissue, and, therefore, fails to disclose determining a direction of water motility as recited in claim 1. Appeal Br. 9. In response, the Examiner refers to paragraphs 29-31 and 35--40 of Buysse and finds that Buysse 3 Appeal2018-007029 Application 12/839,023 clearly teaches that as impedance rises that the tissue undergoes a phase change from a moist state to a solid state and eventually a dried-out state and further teaches that "minimum impedance values 201 depends on many factors including ... tissue hydration level" in paragraph 0031. Therefore, Buysse . . . teaches that hydration level and direction of water motility are directly connected to the minima and maxima of tissue impedance. Ans. 3 ( emphasis added). Thus, the Examiner finds that Buysse discloses a relationship between (i) maximum/minimum values of impedance and (ii) the hydration level of tissue and the water motility in the tissue. Based on these findings, the Examiner concludes, "since Buysse ... determines minima and maxima impedance points[,] Buysse ... therefore determines a hydration level and a direction of water motility." Id. at 3--4. In reply, Appellant states [ a ]t best the Examiner alleges that "direction of water motility moves out of the tissue once it reaches a dried-out state" but fails to address actually determining in which direction the water moves out of the tissue. Thus, even if Buysse discloses that the "direction of water motility" is directly connected to the minima and maxima of tissue impedance, Buysse fails to disclose actually determining "direction of water motility" as recited in claim 1. Reply Br. 2-3. Appellant's Specification defines water motility2 as "a property of vascular or capillary beds that, in contrast to the simple measure of moisture content of tissue, describes the ease with which water can move through pore spaces or fractures." Spec. 7. Water motility is represented in Appellant's Specification with the symbol "K'' and this property "depends 2 Appellant's Specification explains that the terms "hydraulic conductivity" and "water motility" refer to the same property. Spec. 7. 4 Appeal2018-007029 Application 12/839,023 on the intrinsic permeability of the tissue and on the degree of saturation. "3 Id. In explaining how to determine a direction of water motility via measurement of impedance, the Specification states, "[a]s explained in more detail below with respect to FIG. 5, the graphical and/or numerical analysis is specifically directed to identifying specific portions of the maxima and minima of the tissue conductivity/impedance data that correlate to hydration level and direction of water motility." Spec. 14; see also Fig. 5. The Specification further explains, "the response of the impedance change to power on or power off conditions can indicate how permeable the tissue is to bulk water movement or the motility of water through the tissue." Spec. 35 ( emphasis added). Pages 3 8 through 4 7 of the Specification, with reference to Appellant's Figure 5, describe an iterative process that determines a level of water motility by examining the shape of a plotted curve representing the value of the tissue impedance, not from the value of the impedance itself. See Fig. 5. For example, Appellant's Specification states, "[a]t the time of occurrence of the blunt minima 514a and 514b, the tissue membranes have a porosity and a reflectance coefficient[ 4J that are optimal for the occurrence of tissue division upon further application of electrical energy from the electrosurgical generator." Spec. 43 (emphasis added); see also Fig. 5. Thus, Appellant's Specification indicates that the value ofimpedance,per se, does not indicate the level of water motility in tissue. The Examiner's finding that Buysse teaches the step of "determining a hydration level and a direction of water motility in the tissue," as recited in 3 Equation 2 on page 9 of the Specification shows that K is a function of the intrinsic permeability of the material, the specific weight of water, and the dynamic viscosity of water. See Spec. 9. 4 Reflectance is the inverse of water motility, i.e., having high reflectance is the same as having low water motility. Spec. 10. 5 Appeal2018-007029 Application 12/839,023 claim 1, is based on the finding that Buysse teaches a relationship between (i) maximum/minimum values of impedance and (ii) the hydration level of tissue and the water motility in the tissue. See Ans. 3. We disagree with that finding because Buysse does not discuss or mention the property of water motility, and, as explained above, water motility is not directly correlated with impedance. Rather, as explained above, water motility may be determined based on analysis of the shape of a plotted impedance curve, i.e., the way impedance values respond to changes in electrical stimulation. Thus, even assuming, arguendo, that Buysse identifies minima and maxima of impedance readings, such identification, by itself, does not necessarily result in determining a hydration level and a direction of water motility in the tissue as recited in claim 1. Accordingly, we do not sustain the rejection of claim 1 and claims 2, 4, and 11 depending therefrom as unpatentable over Buysse and Boveja. Claim 13 recites a substantially similar process step to the one discussed above regarding claim 1. Appeal Br. 19--20 (Claims App.). Accordingly for the same reasons, we do not sustain the rejection of claim 13, and claims 14 and 15 depending therefrom, as unpatentable over Buysse and Boveja. Rejection II, Buysse, Boveja, and Odom Claim 3 depends from claim 1. Appeal Br. 17 (Claims App.). In rejecting claim 3, the Examiner does not use the teachings of Odom in any way that would remedy the deficiency discussed above regarding the findings of fact with respect to Buysse. See Final Act. 6-7. Accordingly, we do not sustain the rejection of dependent claim 3. 6 Appeal2018-007029 Application 12/839,023 Rejection III, Buysse, Boveja, and Wham Claims 5-8 and 12 depend, directly or indirectly, from claim 1. Appeal Br. 18-19 (Claims App.). In rejecting claims 5-8 and 12, the Examiner does not use the teachings of Wham in any way that would remedy the deficiency discussed above regarding the findings of fact with respect to Buysse. See Final Act. 6-7. Accordingly, we do not sustain the rejection of dependent claims 5-8 and 12. Rejection IV, Buysse, Boveja, Wham, and Irisawa Independent claim 16 recites a substantially similar process step to the one discussed above regarding claim 1. Appeal Br. 21 (Claims App.). Accordingly for the same reasons, we do not sustain the rejection of claim 16 as unpatentable over Buysse, Boveja, Wham, and Irisawa. DECISION The Examiner's decision to reject claims 1-8 and 11-16 is reversed. REVERSED 7