Avanos Medical Sales, LLCDownload PDFPatent Trials and Appeals BoardAug 27, 2021IPR2020-00895 (P.T.A.B. Aug. 27, 2021) Copy Citation Trials@uspto.gov Paper 49 571.272.7822 Date: August 27, 2021 UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ MEDTRONIC, INC., Petitioner, v. AVANOS MEDICAL SALES, LLC, Patent Owner. ____________ IPR2020-00895 Patent 8,882,755 B2 ____________ Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. JUDGMENT Final Written Decision Determining No Challenged Claims Unpatentable 35 U.S.C. § 318(a) IPR2020-00895 Patent 8,882,755 B2 2 Medtronic, Inc. (“Petitioner”) filed a Petition for an inter partes review of claims 1–8, 13, and 17–22 of U.S. Patent 8,882,755 B2 (Ex. 1001, “the ’755 patent”). Paper 3 (“Pet.”). We instituted trial in this proceeding on October 23, 2020. Paper 16 (“DI” or “Institution Decision”). Avanos Medical Sales, LLC (“Patent Owner”) filed a Response.1 Paper 20 (“Resp.”). Petitioner filed a Reply to Patent Owner’s Response and Patent Owner filed a Sur-Reply. Paper 40 (“Reply”); Paper 42 (“Sur-Reply”). A final hearing was held July 23, 2021, whereat the parties presented oral arguments. Paper 48 (“Hr’g Tr.”). We have authority under 35 U.S.C. § 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Petitioner bears the burden of proving unpatentability of the challenged claims, and the burden of persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must prove unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d) (2019). After considering the parties’ arguments and supporting evidence, we conclude that Petitioner has not proven by a preponderance of the evidence that claims 1–9, 11, and 13–19 of the ’755 patent are unpatentable. 35 U.S.C. § 316(e). 1 Patent Owner filed a Preliminary Response to the Petition, which we refer to herein. Paper 11 (“Prelim. Resp.”). IPR2020-00895 Patent 8,882,755 B2 3 I. INTRODUCTION A. REAL PARTIES-IN-INTEREST Petitioner identifies “Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., and Medtronic USA, Inc.,” as the real parties-in-interest. Pet. 1. Patent Owner identifies “Avanos Medical Sales, LLC” and “Avanos Medical, Inc.” as the real parties-in-interest. Paper 6. B. RELATED MATTERS Petitioner identifies “Avanos Medical Sales, LLC. v. Medtronic Sofamor Danek USA, Inc. and Medtronic, Inc., No. 2:19-cv-02754 (W.D. Tenn.)” (the “related district court litigation”) as a related matter. Pet. 2. Patent Owner identifies this same related district court litigation as a related matter and also identifies that several U.S. patents and patent applications “claim the benefit of [ ] priority” to the ’755 patent, but does not indicate there are any specific matters pending for these patents and applications. Paper 6, 1. C. THE ’755 PATENT The ’755 patent issued on November 11, 2014, from U.S. Application 11/105,527, which was filed on April 14, 2005; the ’755 patent indicates it is a continuation-in-part of U.S. Application 10/087,856, which was filed on March 5, 2002, and issued as US 6,896,675; and it also indicates priority to U.S. Provisional 60/604,348, filed on August 25, 2004. Ex. 1001, codes (45), (21), (22), (63), (60); see id. at 1:7–10. Petitioner asserts that the ’755 patent’s claims “are not entitled to an effective filing date of March 5, 2002,” the filing date of the application from which the ’755 patent identifies itself to be a continuation-in-part, but does not identify a specific priority date for the ’755 patent. Pet. 11. Patent IPR2020-00895 Patent 8,882,755 B2 4 Owner states, “[w]ithout conceding that the ’755 Patent is not entitled to an earlier priority date than August 25, 2004, [the filing date of the provisional from which the ’755 patent indicates it depends,] Avanos has assumed this date for the purposes of this inter partes review.” Resp. 3. In the absence of disagreement between the parties,2 we consider August 25, 2004 to be the ’755 patent’s priority date. The ’755 patent introduces its invention by stating: A novel medical probe assembly, system, and methods for the use thereof to treat tissue are described. The system optionally comprises an energy source, two probe assemblies, and one or more cooling devices to provide cooling to at least one of the probe assemblies. The probe assemblies may be configured in a bipolar mode, whereby current flows preferentially between the probe assemblies. The probe assemblies and system described herein are particularly useful to deliver radio frequency energy to a patient’s body. RF energy delivery may be used for various applications, including the treatment of pain, tumor ablation and cardiac ablation. Ex. 1001, Abstract. Such a device is illustrated in the ’755 patent at, for example, Figure 4, which is reproduced below, as annotated by the Panel to label referenced components in red: 2 August 25, 2004, is the priority date for the ’755 patent’s claims recognized by Petitioner’s witness, Dr. Tucker. See, e.g., Ex. 1003 ¶ 21. IPR2020-00895 Patent 8,882,755 B2 5 Id. at Fig. 4. Annotated Figure 4, above, “is a perspective cut-away view of one embodiment of a distal tip region of a probe assembly” according to the disclosure of the ’755 patent, and includes our labeling of components depicted, as described in the Specification. Id. at 7:58–60. Shown above is a portion of a larger probe assembly 106 (see id. at Fig. 1), that portion being generally cylindrically shaped and having hollow elongate shaft 184 (described as being electrically insulating polyamide material) providing an exterior and defining lumen 450 therein. Id. at 12:67–13:2, 13:48–49. Hollow elongate shaft 184 terminates into a domed end having distal tip region 190, which extends from internal stainless steel hypotube 406, is segregated from lumen 450, and houses temperature sensing elements 402, IPR2020-00895 Patent 8,882,755 B2 6 constantan wire 410, and wire insulation 412. Id. at 14:8–46. Shown in open fluid communication with lumen 450 are shaft supply tube 302 for supplying cooling fluid to lumen 450 and shaft return tube 304 for removing cooling fluid from lumen 450; arrow 408 illustrates the flow of such cooling fluid. Id. at 15:27–31. The ’755 patent explains that temperature sensing elements 402 are not “affected by the cooling fluid flowing within [ ] lumen 450.” Id. at 14:45–55. At the device’s distal tip region 190, surrounding the “protrusion” (elements 402, 410, 412), is energy delivery device 192, which may be an electrode for delivering RF energy, or any of a variety of other energy sources for other energy types. Id. at 12:3–11, 14:33–35, 14:65–66. Also shown within hollow elongate shaft 184 is radiopaque marker 440, and proximal thereto are secondary temperature sensing elements 404, including thermal insulator 430, and connected copper 420 and constantan wires 422. Id. at 15:9–17. As noted above, the ’755 patent indicates that its temperature sensor element is not affected by cooling fluid; it further explains: Placing the one or more temperature sensing elements 402 at this location [(in a protrusion)], rather than within lumen 450 defined by the one or more energy delivery devices 192, is beneficial because it allows the one or more temperature sensing elements 402 to provide a more accurate indication of the temperature of tissue proximate to the one or more energy delivery devices 192. This is due to the fact that, when extended beyond the one or more energy delivery devices 192, the one or more temperature sensing elements 402 will not be as affected by the cooling fluid flowing within a lumen 450 as it would be were it located within lumen 450. Thus, in this embodiment of the present invention, probe assembly 106 comprises a protrusion protruding from the distal region of the IPR2020-00895 Patent 8,882,755 B2 7 probe assembly, whereby the protrusion is a component of temperature sensing element 402. Id. at 14:45–59. Two probe assemblies 106 are illustrated in use by the ’755 patent’s Figure 8, reproduced below: Id. at Fig. 8. “FIG. 8 shows two probes placed within an intervertebral disc.” Id. at 8:4–5. As shown in Figure 8, above, two probe assemblies 106 are shown within introducer tubes 802 and distal tip region 190 of each probe assembly 106 is inserted into intervertebral disk 800. Id. at 21:43–48. Each probe assembly 106 has hollow elongate shaft 184, energy delivery device 192 (see id. at Fig. 4), temperature sensing element 402, and secondary temperature sensing element 404. Id. at 21:48–51. The ’755 patent concludes with 22 claims, of which claims 1, 17, 19, 21, and 22 are independent. Id. at 27:65–30:65. Claim 1 is illustrative and reads as follows: IPR2020-00895 Patent 8,882,755 B2 8 1. A medical probe assembly for delivering energy to a patient’s body, the probe assembly comprising: an elongate member having a distal region and a proximal region, said distal region comprising an electrically non-conductive outer circumferential portion; an electrically conductive energy delivery device extending distally from said electrically non-conductive outer circumferential portion for delivering one of electrical and rf energy to the patient’s body, said energy delivery device having a conductive outer circumferential surface and an internal lumen configured for internal longitudinal flow of a cooling fluid to a distal end of said energy delivery device; and an electrically conductive protrusion extending from said distal end of said energy delivery device and having a diameter than [sic, that] is less than a diameter of said energy delivery device, said electrically conductive protrusion being electrically coupled to said energy delivery device for delivering one of electrical and rf energy to the patient’s body and comprising a temperature sensing element, said electrically conductive protrusion protruding distally beyond said lumen such that said cooling fluid does not flow into said electrically conductive protrusion and said temperature sensing element being located within said protrusion such that said cooling fluid does not contact said temperature sensing element, thereby allowing for a more accurate indication of the temperature of tissue proximate to said energy delivery device. Id. at 27:65–28:27. Claims 2–16 depend directly or indirectly from claim 1. Id. at 28:28–29:6. Independent claim 17 is substantially similar to independent claim 1, but is directed to a system for delivering energy to a patient’s body and further recites “an energy source.” Id. at 29:7–31. Claim 18 depends from claim 17. Id. at 29:32–40. Independent claim 19 is directed to a method of treating tissue of a patient’s body using two probe assemblies as are defined IPR2020-00895 Patent 8,882,755 B2 9 by claim 1, further reciting inserting the probes, delivering energy, and measuring temperature. Id. at 29:41–30:7. Claim 20 depends from claim 19. Id. at 30:8–10. Independent claim 21 is directed to a medical probe assembly and is similar to claim 1, but adds “said temperature sensing element protruding beyond said energy delivery device said [sic, such] that it is not affected by the cooling fluid flowing within the lumen.” Id. at 30:11– 37. Independent claim 22 is similar to claim 1, but further defines the temperature sensing element as “said temperature sensing element comprising a thermocouple junction formed within the tube by joining an inner surface of the tube to a wire made from a dissimilar metal, whereby said thermocouple junction is positioned within said protrusion and is separated from said cooling fluid.” Id. at 30:38–65. D. SUMMARY OF PETITIONER’S ASSERTED GROUNDS Petitioner asserts eight grounds for the unpatentability of claims 1–8, 13, and 17–22 of the ’755 patent, as follows: GROUND CLAIMS CHALLENGED 35 U.S.C. § 3 BASIS 1 1, 2, 8, 17, 21 102 Desinger4 2 1, 2, 8, 17, 21 103 Desinger 3 The ’755 patent was filed in the USPTO on April 14, 2005, which is before the AIA revisions to 35 U.S.C. §§ 102, 103, and 112 took effect on March 16, 2013. Therefore, the pre-AIA version of Sections 102, 103, and 112 apply. 4 WO 00/36985 (published June 29, 2000) (Ex. 1004, “Desinger”). Exhibit 1005 is the English translation of Desinger, which was published in German (also “Desinger”). We refer to the English version herein. IPR2020-00895 Patent 8,882,755 B2 10 GROUND CLAIMS CHALLENGED 35 U.S.C. § 3 BASIS 3 19, 20 103 Desinger, Pellegrino5 4 22 103 Desinger, Simpson6 5 3–5, 7 103 Desinger, Levine7 6 6 103 Desinger, Levine, Simpson 7 13 103 Desinger, Sharps8 8 18 103 Desinger, Rittman9 In support of these grounds for unpatentability Petitioner submits, inter alia, the Declaration and Supplemental Declaration of Dr. Robert Tucker (Ex. 1003; Ex. 1042). Similarly, Patent Owner submits the Declaration of Dr. Dieter Haemmerich (Ex. 2027). In view of our application of the level of ordinary skill in the art set forth in Section II.A, below, we determine that each of these witnesses is qualified to offer testimony on the knowledge of one of ordinary skill in the art at the time of the invention. See Ex. 1003 ¶¶ 3–6, 21–23, Appendices A, B; Ex. 2027 ¶¶ 4–11, 36–91, Appendix B. E. REVIEW OF PETITIONER’S ASSERTED PRIOR ART 1. Desinger Desinger is the June 29, 2000 publication of International Patent Application PCT/EP99/10079, filed on December 17, 1999, and asserts priority to German patent application 198 58 599.3, filed on December 18, 5 US 6,907,884 B2 (issued June 21, 2005) (Ex. 1006, “Pellegrino”). 6 US 6,312,425 B1 (issued Nov. 6, 2001) (Ex. 1008, “Simpson”). 7 US 5,647,871 (issued July 15, 1997) (Ex. 1007, “Levine”). 8 US 6,602,248 B1 (issued Aug. 5, 2003) (Ex. 1010, “Sharps”). 9 US 6,575,969 B1 (issued June 10, 2003) (Ex. 1009, “Rittman”). IPR2020-00895 Patent 8,882,755 B2 11 1998. Ex. 1005, codes (43), (21), (22), (30). Thus, under 35 U.S.C. § 102(b), Desinger is prior art to the claims of the ’755 patent, which are accorded priority to August 25, 2004 (see supra Section I.C). Desinger states that its invention relates to a surgical instrument which is provided for carrying out an electrothermal coagulation of tissue. The instrument contains a front cylinder which is situated at the distal end of the instrument and which has distal tip. The inventive instrument also comprises an oblong support and two interspaced cylindrical or strip-like electrodes which are situated at or on the support and which can be connected to a high frequency alternating current source. Ex. 1005, Abstract. Desinger states that such a surgical instrument uses “high-frequency alternating currents (for example in the frequency range of 300 Khz to 2 Mhz) for generating high temperatures for tissue coagulation and tissue separation,” which “has been known for a long time in surgery,” and “[i]n practice, so-called mono-polar electrode arrangements or bipolar electrode arrangements are used to introduce the HF current into the tissue.” Id. at 1. Desinger further states that [t]he advantages of the invention are, in particular, that the electrode arrangement has a particularly simple design, wherein the front cylinder forms an electrode, and the proximally connected outer conductor is insulated by an insulation element to form the second electrode, so that the AC voltage source is directly connectable from the exterior to the outer conductor over the rod-shaped inner conductor, which is segregated by an insulation hose outer conductor. Id. at 3. Desinger discloses a variety of embodiments and features for such surgical instruments. See generally id. Most pertinent to this proceeding are IPR2020-00895 Patent 8,882,755 B2 12 Desinger’s embodiments including electrodes, as mentioned above, but also including other features, such as a specialized tip, temperature sensors, and internal cooling systems. Desinger discloses tips for its instrument can be “conical or wedge-shaped, as needed,” or “pointy or rounded,” and can be “made of metal.” Id. at 6, 8, 9, 13 (generally calling the tip section “a front cylinder”). Such a tip section can be connected to a cylindrical tube section made of metal, which provides an electrode. Id. at 9–10. Desinger calls such an arrangement an “active tip,” which “has the ability to treat edge tumors located directly in front of the rounded [or conical or wedge-shaped] front cylinder.” Id. at 14. The electrode is between the tip and an insulating tube-shaped carrier, which may be held by a second metal tube electrode, which may itself be held by a second tube-shaped carrier. Id. at 9–10. The inside of these tube-shaped sections can define a “hollow channel,” which extends from a proximal end of the instrument to the front cylinder. Id. at 10, 13. Within this hollow channel is provided a “rinsing hose,” which dispenses cooling liquid to the distal end of the instrument. Id. at 10, 11, 13. This cooling liquid flows back to the proximal end of the instrument via the hollow channel. Id. Desinger states that [t]he cooling of the electrode surfaces by means of a rinsing liquid, transfers the so-called “hot spot” of the coagulation into the tissue approximately two to three millimeters from the instrument surface. The cooling ensures that the tissue- electrode contact surface is kept below a predetermined temperature and is therefore not so severely dried out so that the energy introduction into the adjacent tissue is guaranteed over a longer period of time. Id. Areas covered by an insulator are not directly cooled by the cooling fluid and are heated more strongly. Id. IPR2020-00895 Patent 8,882,755 B2 13 Desinger also discloses that [a]dvantageously, a recess specified as an extension of the hollow channel of the carrier in the front cylinder accommodates a temperature sensor whose connection line is guided through the hollow channel to the proximal end of the instrument. As a result, it is possible, for example, to treat benign prostate hyperplasia by positioning a temperature sensor or thermistor into the tip of the front cylinder, which can be used to measure the tissue temperature. Id. at 12. This instrument is described as having similar, cylindrical electrodes as discussed above, where “the outer diameter of the front cylinder also corresponds to the outer diameter of the electrodes.” Id. “The temperature sensor in the recess of the front cylinder is preferably embedded in synthetic resin or in a glue bed [so as to be] able to properly transmit the temperature of the metallic front cylinder to the temperature sensor.” Id. Desinger’s drawings illustrate instruments having features as just discussed. For example, Desinger’s Figure 16, reproduced below, shows “a longitudinal” cross-section of such an instrument: Id. at 19, Fig. 16. Figure 16 shows a cross-section view of a surgical instrument structure’s bipolar electrode arrangement 1 having electrodes 2, 4, (tube sections 82, 84) and front cylinder 10, which tapers into conical IPR2020-00895 Patent 8,882,755 B2 14 distal tip 12. Id. at 24; see id. at 20–25. Insulating carrier 70 supports electrodes 2, 4 and front cylinder 10. Id. A central hollow channel 76 is defined inside carrier 70 and terminates at recess 14 of front cylinder 10. Id. Front cylinder 10 houses temperature sensor 100, which is surrounded by plastic or glue bed 102, which defines recess 14 where hollow channel 76 terminates. Id. Desinger’s Figure 18, reproduced below, also shows features of a surgical instrument as discussed above: Id. at 19, Fig. 18. Figure 18 shows a cross-section view of bipolar electrode arrangement 1 like Figure 16, but having electrodes 2, 4 (again, tube sections 82, 84) separated by a portion of carrier 70a and then supported by another portion of carrier 70b. Id. at 25; see id. at 20–24. Again, arrangement 1 has metal front cylinder 10 with conical distal tip 12, which has a recess (not labeled) similar to Figure 16. Id. at 25–26. No temperature sensing structure is illustrated in this figure. The interior of electrodes 2, 4 and carrier portions 70a, 70b define hollow channel 76, which houses rinsing tube 110. Id. at 25. Rinsing tube 110 is illustrated as dispensing cooling fluid at its distal end (arrows) at the recess, and the fluid is shown to flow IPR2020-00895 Patent 8,882,755 B2 15 back (arrows) to the proximal end of arrangement 1 though hollow channel 76. Id. Desinger concludes with 85 claims, which are also a part of its disclosure. Id. at 30–45. Claims 43–66 are generally multiply dependent from independent claim 42 and each claim’s preceding, intervening dependent claims. Id. at 36–41. Independent claim 42 states: 42. Electrode arrangement for a surgical instrument for electrothermal coagulation in tissue, comprising a front cylinder (10) at the distal end of the instrument, at least one elongated, electrically insulating carrier (70) proximally behind the front cylinder (10), two spaced cylindrical electrodes (2, 4), a hollow channel (76) in longitudinal direction through the carrier (70), connecting lines (90) routed through the hollow channel (76) to connect the electrodes to an alternating current source, characterized in that the electrodes (2, 4) are cylindrical tube sections (82, 84) made of metal that are arranged axially aligned with the carrier in longitudinal direction at a predetermined distance. Id. at 36–37. Claim 44 states: 44. Electrode arrangement for a surgical instrument according to claim 42 or 43, characterized in that a central recess (14) is arranged in the front cylinder (10) as an extension of the hollow channel (76) to accommodate a temperature sensor (100) whose connection line (104) is routed through the hollow channel (76) to the proximal end of the instrument. Id. at 37. Claim 49 depends from “any of claims 42 to 47” and adds “that the distal front cylinder (10) consists of insulating material or metal.” Id. at 38. Claim 50 depends from “any of claims 32 [sic, 42] to 49” and adds “the IPR2020-00895 Patent 8,882,755 B2 16 temperature sensor (100) [recited by claim 44] is embedded in a synthetic resin or adhesive bed (102) in the recess (14) of the front cylinder (10).” Id. Claim 54 depends from claim 53, which depends from “any of claims 42 to 52,” and adds: the first electrode (2) is arranged between the front cylinder (10) and an insulating, tubular, first carrier (70a), the second electrode (4) is arranged between the first carrier (70a) and an insulating, tubular second carrier (70b), and in that the end sections of the electrodes (2, 4) are located on the front cylinder (10), the first and the second carrier (70a, 70b). Id. at 38–39. Claim 57 depends from “any of claims 42 to 56” and adds “a rinsing tube (110) within the hollow channel (76) that runs from the proximal end of the instrument to the front cylinder (10) to dispense liquid at its distal end into the hollow channel (76), in which the liquid flows back to the proximal end of the instrument.” Id. at 39. Finally, claim 59 depends from “any of claims 42 to 58” and adds “that the tip (12) of the front cylinder (10) has a conical or wedge-shaped or rounded shape.” Id. at 39– 40. 2. Pellegrino Pellegrino issued on June 21, 2005, from U.S. Application 10/260,879, which was filed on September 30, 2002. Ex. 1006, codes (45), (21), (22). Thus, under 35 U.S.C. § 102(b), Pellegrino is prior art to the claims of the ’755 patent, which are accorded priority to August 25, 2004 (see supra Section I.C). Pellegrino states that its “invention relates to a method of straddling an intraosseous nerve with an energy transmitting device to improve the therapeutic treatment of the nerve.” Ex. 1006, Abstract. Pellegrino IPR2020-00895 Patent 8,882,755 B2 17 illustrates such a process and the devices used at, for example, Figures 26 and 23, reproduced below: Id. at Figs. 26, 23. Figure 26, above-left, shows “the treatment of a posterior portion of the BVN [(basivertebral nerve)] with a bipolar electrode apparatus of [its] invention.” Id. at 6:19–21. Figure 23, above-right, is a more detailed view of the distal ends of apparatuses as shown in Figure 26 and shows “probe[s] of the present invention having a plurality of active electrodes and a corresponding plurality of return electrodes.” Id. at 6:10–12. Probes 851, 861 in Figure 23 have electrodes 853, 854, 855, 863, 864, 865, and a voltage across the probes can be controlled so that, when placed in a vertebral body as shown in Figure 26, a high frequency voltage can be applied between the probes to heat the target tissue to a desired temperature. Id. at 14:29–61, 17:22–67, 23:32–24:3. IPR2020-00895 Patent 8,882,755 B2 18 Pellegrino discloses that such a probe’s “tip region” may be an electrode “to deliver electrical energy in the vicinity of the tip.” Id. at 19:32–34. Pellegrino also discloses that “[t]emperature probes associated with the apparatus may preferably be disposed on or within the electrode carrier; between the electrodes . . . or within the electrodes.” Id. at 19:54– 58. Pellegrino also discloses including “active cooling means” for such probes, stating: If the active electrode has no active cooling means, it may become be subject to conductive heating by the heated tissue, and the resultant increased temperature in the electrode may adversely affect performance by charring the adjacent bone tissue. Accordingly, in some embodiments, a cool tip active electrode may be employed. The cooled electrode helps maintain the temperature of the electrode at a desired temperature. Cooled tip active electrodes are known in the art. Id. at 18:7–15. 3. Simpson Simpson issued on November 6, 2001, from U.S. Application 09/515,382, which was filed on February 29, 2000. Ex. 1008, codes (45), (21), (22). Thus, under 35 U.S.C. § 102(b), Simpson is prior art to the claims of the ’755 patent, which are accorded priority to August 25, 2004 (see supra Section I.C). Simpson introduces its invention as follows: [a] tip electrode for an ablation catheter mounted at the distal tip of an elongated catheter body member has a distal-end region and a proximal-end region. A tip thermal sensor is located at or near the apex of the distal-end region and one or more side thermal sensors are located near the surface of the proximal-end region. The electrode is preferably an assembly formed from a hollow dome-shaped shell with a core disposed IPR2020-00895 Patent 8,882,755 B2 19 within the shell. The side thermal sensor wires are electrically connected inside the shell and the core has a longitudinal channel for the side thermal sensor wires welded to the shell. The shell also preferably has a pocket in the apex of the shell, and the end thermal sensor wires pass through the core to the apex of the shell. Spaces between the shell and the core can be filled with epoxy resin. Alternatively, the electrode is formed of a solid metal having a plurality of bores for positioning thermal sensors at the tip and near the surface of the electrode. Ex. 1008, Abstract. Simpson’s Figures 11a and 11b, reproduced below, illustrate such a device: Id. at Figs. 11a, 11b. “FIG. 11a is a longitudinal view of one embodiment of the tip electrode of FIG. 2 having a solid core and showing the location of a tip sensor and multiple side sensors” and “FIG. 11b is an end view of the tip electrode shown in FIG. 11a taken along the line 11b–11b of FIG. 11a and showing the location of and attachment of sensor leads to the electrode.” Id. at 6:19–26. These figures show tip electrode 36b of a solid material core, having distal end 37 and proximal end 39. Id. at 12:64–13:5. A tip-sensor lead 76b is provided in pocket 66b; tip-sensor lead 76b and common lead 42b are soldered in pocket 66b at or near apex 68b to form tip-sensor junction 72b. Id. at 13:6–15; see id. at Figs. 12a–12b. Other, similar IPR2020-00895 Patent 8,882,755 B2 20 peripheral sensor leads 84b are also provided. Id. at 13:25–27. Leads 76b, 84b are formed of constantan, alloy-11, and platinum. Id. at 13:28–34; see id. at Figs. 3, 4, 12a, 12b. 4. Levine Levine issued on July 15, 1997, from U.S. Application 402,881, which was filed on March 10, 1995. Ex. 1007, codes (45), (21), (22). Thus, under 35 U.S.C. § 102(b), Levine is prior art to the claims of the ’755 patent, which are accorded priority to August 25, 2004 (see supra Section I.C). Levine introduces its invention as follows: A cooled electrosurgical system includes an electrosurgical device having at least one electrode for applying electrical energy to tissue. In one embodiment, the electrode includes an internal cavity in which a cooling medium such as water is contained. The internal cavity is closed at the distal end of the device such that the cooling medium is contained within the electrode at the surgical site such that the cooling medium does not contact the tissue being treated. Ex. 1007, Abstract. Such a system is illustrated in Levine’s Figures 1A and 1B, reproduced below: IPR2020-00895 Patent 8,882,755 B2 21 Id. at Figs. 1A, 1B. “FIG. 1A is a schematic illustration of a cooled monopolar electrosurgery system in accordance with the present invention” and “FIG. 1B is a schematic cross-sectional view of the cooled monopolar electrosurgical device of FIG. 1A taken along line B-B of FIG. 1A.” Id. at 3:62–67. These figures show cooled monopolar electrosurgery system 10 with probe 12, connected to control pencil 14. Id. at 4:62–67. Ball end electrode 26 is cooled by circulating cooling fluid, such as water, which is supplied from source bag 34, routed into probe 12 via tubing 36, then routed to distal end 23 via inlet tube 40, where it flows out into cavity 42. Id. at 5:30–38. Conductive spacer 24 restricts the fluid to cavity 42. Id. at 5:6–9, 5: 47–49. The fluid then flows back toward the probe’s proximal end via second tube 44, and exits the probe and is routed to collection bag 50 via tubing 48. Id. at 5:38–42. 5. Sharps Sharps issued on August 5, 2003, from U.S. Application 09/676,194, which was filed on September 28, 2000; Sharps claims priority to several prior patent applications and to Provisional 60/224,107, which was filed on August 9, 2000. Ex. 1010, codes (45), (21), (22), (63), (60). Regardless of its priority, under 35 U.S.C. § 102(b), Sharps is prior art to the claims of the ’755 patent, which are accorded priority to August 25, 2004 (see supra Section I.C). Sharps states that its invention relates to [a]pparatus and methods for treating an intervertebral disc by ablation of disc tissue. A method of the invention includes positioning at least one active electrode within the intervertebral disc, and applying at least a first high frequency voltage IPR2020-00895 Patent 8,882,755 B2 22 between the active electrode(s) and one or more return electrode(s), wherein the volume of the nucleus pulposus is decreased, pressure exerted by the nucleus pulposus on the annulus fibrosus is reduced, and discogenic pain of a patient is alleviated. Ex. 1010, Abstract. Sharps discloses that, during such a process, “[v]isualization of the shaft [of the electrode tool] may be enhanced by inclusion of a radiopaque tracking device on the distal end of the shaft.” Id. at 7:3–4. Sharps discloses that a tracking device may be a “radiopaque marker.” Id. at 56:54–58, Fig. 42. 6. Rittman Rittman issued on June 10, 2003, from U.S. Application 09/642,309, which was filed on August 21, 2000. Ex. 1009, codes (45), (21), (22). Thus, under 35 U.S.C. § 102(b), Rittman is prior art to the claims of the ’755 patent, which are accorded priority to August 25, 2004 (see supra Section I.C). Rittman states that its invention is related to target volume ablation in the body using a cooled-tip tissue-heating probe such as a fluid cooled (perfusion cooled) high frequency electrode. The present application relates in part to examples of specific embodiments of high frequency and radiofrequency electrode designs and heating and cooling system designs. It further describes embodiments in conjunction with 3-D or 2-D image data and computer graphic workstions [sic, workstations] to control, monitor, and pre-plan the process of target ablation. Specific examples of cooled-tip electrode constructions will be given which have utility for percutaneous or intraoperative cancerous tumor ablation. Cooled tip electrode systems with modular or separable components involving an insertion cannula, a radiofrequency electrode element, a cooling element, and a thermo-monitoring and/or radiofrequency connection electrode will be given. A IPR2020-00895 Patent 8,882,755 B2 23 high frequency and cooling system which is controlled and regulated based on the “thermally clamped tip” concept together with control of power, current, or other high frequency power parameters to pre-plan and control lesion size will be shown. Pre- or contemporaneous monitoring methods using CT, MR, ultrasound, and acoustic imaging or monitoring modalities in conjugation with the cooled tip high frequency ablation system will be exemplified. Ex. 1009, Abstract. Such a system, in use, is illustrated by Rittman at Figure 11, reproduced below: Id. at Fig. 11. “FIG. 11 shows a schematic arrangement of a thermosurgery probe in conjugation with other electrodes or probe, some of which may be cooled, which can be used to modify the thermal ablation volume while protecting delicate structures in the vicinity.” Id. at 3:63–67. The figure shows a system of RF generator (or other heating generator) with a computer to control, monitor, or feedback parameters of the IPR2020-00895 Patent 8,882,755 B2 24 thermosurgery, or to preplan the ablation, or to map, fuse, or update images from one or more image scanners before, during, or after the thermosurgery or ablation process, alternatively in another embodiment to control, monitor, feedback a cooling supply and flow to a cooled electrode(s) or boundary controlling elements. Id. at 2:48–55. More specifically, Figure 11 shows “a complex of heating and cooling electrodes which can be used to approach a complex structure within the body and define heat and cooling boundary conditions so as to shape the ablation volume.” Id. at 29:36–40. Also shown are body tissue masses 1106A, 1101, 1106B, and a system with electrodes 1109, 1104, cooling supply or control units 1128, 1122, and RF supplies 1124, 1127, where “the cooling fluid or agent may be turned off and on to suit the situation.” Id. at 29:36–31:14, 32:26–27. Any combination of cannula, RF probe, cooling element, thermosensors (to measure tip and/or tissue temperatures in real-time), stylets, etc. are contemplated by Rittman. Id. 32:40–65. II. DISCUSSION A. ORDINARY LEVEL OF SKILL IN THE ART Petitioner states that [a] POSA [(person of ordinary skill in the art or skilled artisan)] in 2004 would have been either (i) a medical doctor with experience using ablation devices, including, but not limited to RF ablation devices, and with training, experience and/or familiarity applying principles of engineering to the design, development, and/or testing of such devices, or (ii) an engineer or physicist having at least a bachelor of science degree and with three years of experience in the design, development, and/or testing of ablation devices, including, but not limited to RF ablation devices, and their clinical use; a IPR2020-00895 Patent 8,882,755 B2 25 higher level of education could reduce the number of years of experience required. Pet. 12 (citing Ex. 1003 ¶¶ 21–23). Patent Owner states that “[f]or purposes of this inter partes review, Avanos has adopted Medtronic’s definition of a person of ordinary skill in the art. (Pet., 12.).” Resp. 17. Our findings and conclusions do not turn on selecting a particular definition for the level of ordinary skill in the art. We accept Petitioner’s unopposed definition of the ordinarily skilled artisan, which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’755 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). B. CLAIM CONSTRUCTION The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe claims in a civil action in federal district court. 37 C.F.R. § 42.100(b). In construing claims, district courts and the Board give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). “Because the meaning of a claim term as understood by persons of skill in the art, is often not immediately apparent, and because patentees frequently use terms idiosyncratically, the court [or the Board] looks to ‘those sources available to the public that show what a person of skill in the IPR2020-00895 Patent 8,882,755 B2 26 art would have understood disputed claim language to mean.’” Id. at 1314 (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)). Such sources for claim interpretation include “the words of the claims themselves, the remainder of the specification, the prosecution history [i.e., the intrinsic evidence], and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Id. at 1314 (quoting Innova, 381 F.3d at 1116). “[T]he claims themselves [may] provide substantial guidance as to the meaning of particular claim terms.” Id. However, the claims “do not stand alone,” but are part of “‘a fully integrated written instrument,’ . . . consisting principally of a specification that concludes with the claims,” and therefore, the claims are “read in view of the specification.” Id. at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 978–79 (Fed. Cir. 1995)). Any special definition for a claim term must be set forth in the specification with “reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Without such a special definition, however, limitations may not be read from the specification into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). IPR2020-00895 Patent 8,882,755 B2 27 We analyze the parties’ positions on claim interpretation in view of these standards of law. Petitioner submits a single claim limitation for construction. Petitioner asserts that the claim language “means of delivering a fluid to, and removing said fluid from, said lumen,” recited by claim 2, is a means-plus- function limitation under 35 U.S.C. § 112 ¶ 6. Pet. 13. Petitioner’s position is that this language’s use of the term “means” without further reciting sufficient definite structure invokes a means-plus-function interpretation. Id. Petitioner asserts that the claimed function is “[d]elivering a fluid to, and removing said fluid from, the lumen.” Id. (citing Ex. 1003 ¶ 56). Petitioner asserts that the corresponding structure described in the Specification is “[o]ne or more tubes, for example as shown in Figures 3A, 3B, 4, 5A, 5B, 6A, 6B, 6C, 7, and 9A, and structural equivalents thereof.” Id. at 14 (citing Ex. 1003 ¶ 57). Petitioner cites paragraph 57 of the Tucker Declaration, which indicates that this corresponding structure is described in the ’755 patent at: “Figures 3A, 3B, 4, 5A, 5B, 6A, 6B, 6C, 7, 9A, col[s]. 6:14-22, 7:37-41, 9:35-41, 11:18-25, 12:53-13:5, 13:8-17, 13:25-28, 15:29- 31, 15:65-16:4, 16:33-36, 17:5, 17:9-18, 17:24-31, 17:49-18:8.” Ex. 1003 ¶ 57. Regarding claim construction, Patent Owner expressly states only the following: “Avanos does not dispute Medtronic’s construction of Claim 2’s “means for delivering . . .’ (Pet., 13–14), and has adopted that construction.” Resp. 17. We find, on the record before us, Petitioner’s uncontested position that the above-noted claim language is a means-plus-function limitation is IPR2020-00895 Patent 8,882,755 B2 28 correct for the reasons set forth by Petitioner noted above. See, e.g., Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1361 (Fed. Cir. 2000) (“Use of the term ‘means’ in a claim limitation creates a presumption that section 112, paragraph 6 has been invoked [and] that presumption may be rebutted if the properly construed claim limitation itself recites sufficiently definite structure to perform the claimed function.”). We agree with Petitioner that no specific structure is set forth in claims 1 or 2 for the claimed function of delivering fluid to and removing fluid from a lumen. To properly understand the claim language at issue, we note, for context, that the “lumen” recited by dependent claim 2, which depends from independent claim 1, refers to “an internal lumen configured for internal longitudinal flow of a cooling fluid to a distal end of said energy delivery device,” as recited by claim 1 (the further recited “energy delivery device” of claim 1 and is directed to an electrically conductive device that extends distally from a non-conductive outer circumferential portion of a distal region of an elongate member of the claimed medical probe). Ex. 1001, 27:66–28:30. We agree with Petitioner, as does Patent Owner (Prelim. Resp. 17), that the function recited in the claim for the “means” at issue is delivering a fluid to, and removing said fluid from, the claimed lumen, discussed above. Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1351–52 (Fed. Cir. 2015) (en banc) (“Construing a means-plus-function claim term is a two-step process. The court must first identify the claimed function.”). We also agree with Petitioner, as does Patent Owner (Prelim. Resp. 17), that the portions of the ’755 patent’s Specification cited in paragraph 57 of the IPR2020-00895 Patent 8,882,755 B2 29 Tucker Declaration identify the corresponding structure to be one or more tubes (or tubular members, which is synonymous with tubes). See id. (“Structure disclosed in the specification qualifies as ‘corresponding structure’ if the intrinsic evidence clearly links or associates that structure to the function recited in the claim.”) Thus, we agree with and adopt, as does Patent Owner (Prelim. Resp. 17), Petitioner’s proposed interpretation of “means of delivering a fluid to, and removing said fluid from, said lumen,” as one or more tubes, and equivalent structures. The parties do not expressly request any other claim language be construed in this proceeding and we take no position on the meaning of any other claim language, other than to recognize that it would carry the ordinary meaning as would have been understood by the ordinarily skilled artisan at the time of the invention. C. APPLICABLE LEGAL STANDARDS As noted above, “[i]n an IPR, the petitioner has the burden from the onset to show with particularity why the [claims of the] patent it challenges [are] unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, 800 F.3d at 1378 (discussing the burden of proof in inter partes review). Regarding anticipation, our reviewing court has held: a patent is invalid [or unpatentable] as anticipated if “the [claimed] invention was described in” a patent or published application “before the invention by” the patentee. 35 U.S.C. § 102(e). In order to anticipate the claimed invention, a prior IPR2020-00895 Patent 8,882,755 B2 30 art reference must “disclose all elements of the claim within the four corners of the document,” and it must “disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed. Cir. 2017) (emphasis added). If an independent claim is not anticipated by prior art, dependent claims including that independent claim’s limitation that is missing from the prior art are also not anticipated. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002). Regarding obviousness, the Supreme Court, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), reaffirmed the framework for determining obviousness as set forth in Graham v. John Deere Co., 383 U.S. 1 (1966). The KSR Court summarized the four factual inquiries set forth in Graham (383 U.S. at 17–18) that are applied in determining whether a claim is unpatentable as obvious under 35 U.S.C. § 103(a) as follows: (1) determining the scope and content of the prior art; (2) ascertaining the differences between the prior art and the claims at issue; (3) resolving the level of ordinary skill in the pertinent art; and (4) considering objective evidence indicating obviousness or non-obviousness. KSR, 550 U.S. at 406. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the answer depends on “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 417. In analyzing IPR2020-00895 Patent 8,882,755 B2 31 the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” Id. at 418. Importantly, as with anticipation, a proper § 103 analysis requires “a searching comparison of the claimed invention—including all its limitations—with the teachings of the prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995) (emphasis added). When considering the issue of obviousness, expressly recited claim limitations are not mere peripheral issues where conclusions of a party or the Board may substitute for core factual findings based on evidence that the limitation is met by the prior art. K/S Himpp v. Hear-Wear Technologies, LLC, 751 F.3d 1362, 1365 (Fed. Cir. 2014). “[I]f [an independent] claim [ ] is not obvious then [its dependent] claims [ ] also cannot be obvious because they all depend from a nonobvious claim.” Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358, 1365 (Fed. Cir. 2008) (citing In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992), which states “dependent claims are nonobvious if the independent claims from which they depend are nonobvious”). With these standards in mind, and in view of the definition of the skilled artisan and claim interpretation discussed above, we address Petitioner’s challenges below. IPR2020-00895 Patent 8,882,755 B2 32 D. ANTICIPATION OR OBVIOUSNESS OF THE CLAIMS BASED UPON DESINGER, INDIVIDUALLY OR IN COMBINATION WITH OTHER CITED PRIOR ART We address all of Petitioner’s grounds for unpatentability together because they all share the same shortcoming. As noted above at Section I.D., each of Petitioner’s grounds is foundationally based on the disclosure of Desinger. Because we find that Desinger does not teach or suggest an expressly recited claim limitation, namely, “said cooling fluid does not flow into said electrically conductive protrusion,” which is recited by each independent claim and, therefore, required by every challenged claim, we conclude that Petitioner has not shown by a preponderance of the evidence that any claim is unpatentable. See Ex. 1001, 28:20–22 (claim 1), 29:26–28 (claim 17), 29:61–63 (claim 19), 30:32–34 (claim 21), 30:56–58 (claim 22). Petitioner does not assert that this claim limitation is disclosed by any cited prior art reference other than Desinger or would have otherwise been an obvious modification to Desinger’s disclosed designs. See Pet. 25– 30, 33–34, 36, 38–42, 45, 47, 50–52, 60–61. Thus, because we find Desinger does not disclose, teach, or suggest this claim limitation, we conclude Petitioner’s proof of unpatentability is deficient. We discuss the matter in more detail below. Under its grounds for unpatentability, but most expressly under Grounds 1–4, Petitioner asserts that independent claims 1, 17, 19, 21, and 22, and dependent claims 2–8, 13, 18, and 20, are either anticipated or would have been obvious over the prior art because, inter alia, Desinger discloses “said cooling fluid does not flow into said electrically conductive protrusion,” as recited by each independent claim. Pet. 25–30, 33–34, 36, IPR2020-00895 Patent 8,882,755 B2 33 38–42, 45, 47, 50–52, 60–61 (citing Ex. 1005, Abstract, claims 42, 44, 49, 50, 52–54, 57, 59, pages 8–10, 12, 14, 19, 24–26, 29, Figs. 16–18; Ex. 1003 ¶¶ 94–104, 122–123, 129–140, 148, 154, 165–167, 206). Relatedly, Petitioner foundationally relies on Desinger as disclosing such a claimed “protrusion” as its “element 10 with tip 12,” for example, Petitioner asserts that “a POSA would understand front cylinder 10 with pointed tip 12, meets the claim limitation requiring the protrusion . . . .” See id. at 25–30, 33, 36, 38–40, 44–47, 49–51, 60–61 (citing Ex.1005, claims 42, 44, 49, 50, 52–54, 57, 59, pages 8–10, 12, 14, 19, 24–26, 29, Figs.16, 18; Ex.1003 ¶¶ 94–104, 115–117, 122–123, 130–131, 147, 154, 166). Each of Petitioner’s grounds for unpatentability relies upon a combination of the embodiments Desinger discloses in relation to its Figures 16 and 18 as teaching the claimed protrusion. Relevant to this, Petitioner reproduces these two Desinger figures several times throughout the Petition, annotated to illustrate what Petitioner asserts is Desinger’s disclosure of the claimed protrusion and of the claimed limitation requiring that “cooling fluid does not flow into said electrically conductive protrusion.” See id. at 26, 39; see also Reply 8–10 (explaining that “Petitioner does not need to rely on inherency” because Desinger Figures 16 and 18 show fluid only abuts the glue in the front cylinder, but does not penetrate it); Ex. 1003 ¶¶ 102, 130 (Dr. Tucker relying on the same annotated figures); and Ex. 1042 ¶ 55 (Dr. Tucker renewing his reliance on such an understanding of Desinger). We reproduce these Desinger figures, as annotated by Petitioner, below: IPR2020-00895 Patent 8,882,755 B2 34 Designer Figures 16 and 18, as annotated by Petitioner, show in cross- section view two probe embodiments having a cylindrical body with coloring to distinguish various components, most particularly a front cylinder colored red and a central lumen, which in Figure 18 holds cooling fluid, colored blue. Petitioner’s annotations to these figures also include text identifying front cylinder 10 with conical distal tip 12 as the claimed “electrically conductive protrusion” and asserting that the cooling fluid (shown colored blue in Figure 18) “does not flow into said electrically conductive protrusion.” IPR2020-00895 Patent 8,882,755 B2 35 In addition to the above-reproduced annotated Desinger figures, Petitioner also provides a more zoomed-in, annotated version of Desinger’s Figure 16, which we reproduce below: Pet. 30, 40; Ex. 1003 ¶¶ 101, 133. This Petitioner-annotated version of Desinger’s Figure 16 shows a larger cross-sectional view of the distal tip end of the probe having front cylinder 10 with conical tip 12 (colored red), identified again with text as the “electrically conductive protrusion.” The figure is further annotated with text identifying feature 100 as a temperature sensor (colored green), feature 102 as a plastic or glue bed (colored yellow), and feature 14 as a recess in front cylinder (also colored yellow). Adjacent to the recess 14 is a blue colored region that Petitioner annotates as identifying a central hollow channel 76 (“Lumen”). In asserting that Desinger discloses the claimed element of “cooling fluid does not flow into said electrically conductive protrusion,” Petitioner IPR2020-00895 Patent 8,882,755 B2 36 repeatedly makes the point that, because Desinger’s “temperature sensor is ‘surrounded by a plastic or glue bed 102,’ . . . any internal cooling fluid is necessarily blocked from contacting the temperature sensor.” Pet. 29 (citing Ex. 1005, 24; Ex. 1003 ¶101), 39–40 (similarly interpreting Desinger under Ground 2). Petitioner takes the position that “Desinger, therefore, discloses an electrically conductive protrusion with a temperature sensing element located within said protrusion such that the cooling fluid does not contact the temperature sensing element. (Ex.1003, ¶101).” Id. at 29. Petitioner also asserts that “a POSA would understand that the cooling fluid does not flow into said electrically conductive protrusion based on the figures in Desinger,” such as the annotated figures we reproduced above. Id. at 30. Specifically, Petitioner asserts that Desinger’s Figure 18 shows internally dispensed cooling fluid “does not flow into the front cylinder (10) with conical tip (12), which is shown to be solid.” Id. Petitioner concludes, “[t]hus, Desinger anticipates claim 1 of the ’755 patent” and “[t]hus, claim 1 is obvious over Desinger.”10 Id. at 30, 43. Patent Owner presents several arguments in response to Petitioner’s challenges, one of which is that “Desinger does not disclose ‘an electrically conductive protrusion . . . such that cooling fluid does not flow into said electrically conductive protrusion.’”11 Resp. 26–29 (responsive to 10 We recognize that this is not the extent of Petitioner’s assertions and evidence regarding how Desinger reads on other subject matter recited by claim 1, but this issue is determinative and, so, no other assertions or evidence need be addressed. 11 This is an argument Patent Owner did not present in its Preliminary Response; nor was it required to do so. IPR2020-00895 Patent 8,882,755 B2 37 Ground 1), 40–41 (responsive to Ground 2), 51 (responsive to Grounds 3–8), 54–55 (addressing claim 22 and Simpson’s failure to remedy Desinger’s shortcoming) 56 (addressing Levine, Simpson, and Sharps as failing to remedy Desinger’s shortcoming); see also Sur-Reply 9–10 (addressing this limitation). We are persuaded by Patent Owner’s argument, as we explain further below. Patent Owner argues that “Desinger shows a ‘recess’ in front cylinder 10 where cooling fluid would flow,” and “Medtronic relies on Figures 16 and 18 of Desinger as disclosing th[e] limitation [at issue]. (Pet., 18-19.) Figure 18, however, depicts a rounded recess in the front cylinder where cooling fluid would flow.” Resp. 26 (citing Ex. 1005, Fig. 18; Ex. 2027 ¶¶ 243–247). To accompany these statements, Patent Owner provides the following annotated portion of Desinger Fig. 18: Id. The image above shows the left-half of the now-familiar Desinger Figure 18, annotated by Patent Owner with color to identify front cylinder 10 in orange and the cooling fluid flowing within hollow channel IPR2020-00895 Patent 8,882,755 B2 38 76 in blue. See Ex. 1005, 25–26. Further describing the image above, Desinger states: a rinsing hose provided within the hollow channel extends from the proximal end of the instrument to the front cylinder, e.g. also through the tube sections forming the electrodes, in order to extend up to the front cylinder, the rinsing hose dispensing liquid into the hollow channel at its distal end, and the liquid - while in contact with the electrodes - flowing back to the proximal end of the instrument in said hollow channel. Id. at 10; see also id. at 11 (“the rinsing hose extending up to the front cylinder and dispensing cooling fluid at the distal end into the hollow channel”). Moreover, Desinger states: In this preferred embodiment of the invention, a hollow channel extends all the way into the front cylinder through the carrier and accommodates a rinsing hose that dispenses rinsing fluid at its distal end that flows back to the proximal end along the inner wall of the front cylinder and finally between the carrier and the rinsing hose. Id. at 13. Regarding Desinger’s Figure 18, we agree with Patent Owner that it shows, and Designer describes in the quote set forth directly above, that cooling fluid flows into the structure of Desinger’s front cylinder 10, as the figure clearly depicts a recess (unlabeled) in the front cylinder’s structure, where hollow channel 76 of the probe extends into that recess, and cooling fluid (arrows) flows into that recess. See Ex. 1005, 10–13, 25–26, Fig. 18; see also Ex. 2027 ¶¶ 208, 242–247 (Dr. Haemmerich discussing Desinger). However, Petitioner’s position on anticipation and obviousness relies upon merging Desinger’s embodiments shown in its Figures 16 and 18. Thus, Patent Owner further argues that IPR2020-00895 Patent 8,882,755 B2 39 if cooling fluid were added to the probe of Figure 16, the fluid would circulate within the “central hollow channel 76 that extends axially through the carrier 70.” (Ex.1005, 25.) That hollow channel “terminates into a recess 14 within the front cylinder 10.” (Id.; see also id., claim 44 (“central recess (14) is arranged in the front cylinder (10) as an extension of the hollow channel (76)”); Ex.2027, ¶¶244-246) Consistent with those descriptions, if cooling flow were circulated within the hollow channel of Figure 16, it would extend into the recess (14) and, therefore, into the front cylinder[.] Resp. 27. Again, Patent Owner accompanies this point with an annotated figure, this time Desinger’s Figure 16, which we reproduce below: Id. The image above shows the left-half of Desinger’s Figure 16, annotated by Patent Owner with color to identify front cylinder 10 in orange and what would be cooling fluid within hollow channel 76 were it present per Figure 18’s embodiment. The image further shows temperature sensor 100 embedded within plastic or glue bed 102 of front cylinder 10, where this structure has recess 14. Ex. 1005, 24, Fig. 16. The recess 14 is colored blue to indicate that cooling fluid from hollow channel 76 would flow therein. IPR2020-00895 Patent 8,882,755 B2 40 Regarding this recess 14 shown in Figure 16, Desinger states, “[a] central hollow channel 76 that extends axially through the carrier 70 terminates into a recess 14 in the front cylinder 10 that accommodates a temperature sensor 100, which is surrounded by a plastic or glue bed 102.” Id. at 24. We, therefore, agree with Patent Owner’s position that, when the teachings from Desinger’s embodiments of its Figures 16 and 18 are merged, the resulting structure would allow the cooling fluid depicted in Desinger’s Figure 18 to flow into front cylinder 10, which houses temperature sensor 100, depicted in Desinger’s Figure 16. See Ex. 2027 ¶¶ 208, 242–247 (Dr. Haemmerich discussing Desinger). It is immaterial whether such cooling fluid would or could contact the temperature sensor directly or influence its measurements because the claims only require that “cooling fluid does not flow into said electrically conductive protrusion,” which it would, based on Desinger’s disclosure and Petitioner’s own position that front cylinder 10 with conical tip 12 is the claimed “protrusion.” See, e.g., Pet. 25 et seq. No claim requires that cooling fluid not contact a temperature sensor. If there was any doubt that our understanding of the teachings from Desinger’s merged Figures 16 and 18 structure is accurate, Petitioner’s witness, Dr. Tucker, resolves such doubt. Dr. Tucker testifies that Desinger’s Figure 16, indeed, includes recess 14 where the cavity of hollow channel 76 extends there-into. See Ex. 2028, 139:22–141:5 (“Q And so even though in your report that is colored yellow, in fact, that is open area, right? A Yes, it is . . . .”); see also id. at 106 (errata sheet 1, correcting “glue” versus “blue,” resulting in recess 14 being blue). Patent Owner IPR2020-00895 Patent 8,882,755 B2 41 submits (at Resp. 28) a comparison of Petitioner’s annotated Desinger Figure 16 as original to the Petition and as amended by Dr. Tucker during his testimony, which we reproduce below: Resp. 28 (citing Ex. 2028, 139:22–141:5; Ex. 1003 ¶101; Ex. 1005, Fig. 15; Ex. 2014). The image above shows, side-by-side, annotated Designer Figure 16 from the Petition and Dr. Tucker’s Declaration compared to the same image as Exhibit 1 from Dr. Tucker’s deposition where he corrected the annotation to show that recess 14 should be a blue extension of hollow channel 76. Thus, Dr. Tucker confirms that cooling fluid (shown in blue above) would flow into Desinger’s front cylinder 10 (shown in red above) when Desinger’s Figures 16 and 18 embodiments are merged. This relationship between Desinger’s front cylinder 10, its recess 14, and hollow channel 76, which would hold cooling fluid, is, perhaps, more clearly illustrated by Patent Owner’s annotated Desinger Figure 16 in its Sur-Reply, which we reproduce below: IPR2020-00895 Patent 8,882,755 B2 42 Sur-Reply 9–10 (citing Ex. 1005, Fig. 16; Ex. 2028, 139:22–141:5; Ex. 2014). The image above shows the external dimensions of a cross- section of front cylinder 10 in orange outline, glue bed 102 in red holding temperature sensor 100 in purple, and hollow channel 76 and cooling fluid therein extending into recess 14 inside front cylinder 10 in blue. Id. We find this to be an accurate depiction of what would result from Desinger’s merged Figures 16 and 18 embodiments, as proposed by Petitioner. As shown, cooling fluid would flow into front cylinder 10. Petitioner responded to Patent Owner’s argument in its Reply, where it argues that Desinger’s figures “are not to scale.” Reply 8. Petitioner argues that what Designer shows is that cooling fluid merely abuts the front cylinder 10; it may flow against it, but it does not flow into it. Id. at 9 (citing Ex. 1042 ¶¶ 54–58). And, Petitioner reiterates that, regarding Desinger’s teachings as they relate to the ’755 patent’s claims, it “does not need to rely on inherency” because cooling fluid does not penetrate the glue bed of IPR2020-00895 Patent 8,882,755 B2 43 Desinger’s front cylinder to reach the temperature sensor. Id. at 10 (citing Pet. 28, 40; Ex. 1043, 258:6–17; Ex. 1042 ¶¶ 59–62; Ex. 1005, 12, 24). We are not persuaded by these points, as they are at odds with Designer’s disclosure, as discussed above, and with what the claims of the ’755 patent require. As discussed above, whether Designer’s drawings are to scale or not, the reference shows cooling fluid flowing into its front cylinder. Drawings may be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. See, e.g., In re Aslanian, 590 F.2d 911, 914–15 (CCPA 1979). Here, viewing Figures 16 and 18 as they relate to each other without relying on whether they were drawn to scale, as confirmed by further teachings of Desinger, shows that the combination of Figures 16 and 18 of Desinger does not teach the claimed “said cooling fluid does not flow into said electrically conductive protrusion.” Desinger states that its rinsing hose in its hollow channel extends to the front cylinder, dispensing cooling liquid into the hollow channel, and also confirms that the recess in the front cylinder is the terminal part of the hollow channel. Ex. 1005, 10–13, 24. Thus, upon combining the teachings of Desinger’s embodiments, cooling fluid flows from the rinsing hose and into the hollow channel and the recess in the front cylinder, which is inside the front cylinder. See In re Wright, 569 F.2d 1124, 1127–28 (CCPA 1977) (indicating the description of the figure, can be relied on in combination with the figure for what it would reasonably teach one of ordinary skill in the art). Moreover, the claims do not require that cooling fluid not reach the temperature sensor; they require “cooling fluid does not flow into said electrically conductive protrusion,” which Desinger shows it does. IPR2020-00895 Patent 8,882,755 B2 44 Ex. 1001, 28:20–22 (claim 1), 29:26–28 (claim 17), 29:61–63 (claim 19), 30:32–34 (claim 21), 30:56–58 (claim 22); Ex. 1005, 9–13, 24–26, Figs. 16, 18. Having considered the evidentiary record before us and the parties’ respective positions on each ground asserted in the Petition, we find that Petitioner has not shown that claims 1–8, 13, and 17–22 are anticipated by Desinger or would have been obvious over Desinger individually or in combination with the other cited prior art references. As noted above, according to Petitioner, front cylinder 10 with its conical tip 12 is the claimed “protrusion.” See Pet. 25–30, 33, 36, 38–40, 44–47, 49–51, 60–61 (citing Ex.1005, claims 42, 44, 49, 50, 52–54, 57, 59, pages 8–10, 12, 14, 19, 24–26, 29, Figs.16, 18; Ex.1003 ¶¶ 94–104, 115–117, 122–123, 130– 131, 147, 154, 166). As discussed, upon analyzing Desinger in view of the parties’ positions, we find Designer teaches that cooling fluid flows into front cylinder 10. Thus, we find that the preponderance of the evidence supports Patent Owner’s position that the prior art of Petitioner’s challenges does not disclose, teach, or suggest a structure where “cooling fluid does not flow into said electrically conductive protrusion,” which is required by every claim of the ’755 patent. Therefore, we find that Petitioner has not shown that any challenged claim is unpatentable. III. CONCLUSION On the record in this proceeding, Petitioner has not shown by a preponderance of the evidence that claims 1–8, 13, and 17–22 of the ’755 patent would have been unpatentable in view of the cited prior art. In summary: IPR2020-00895 Patent 8,882,755 B2 45 Claims 35 U.S.C. § References Claims Shown Unpatentable Claims Not Shown Unpatentable 1, 2, 8, 17, 21 102 Desinger 1, 2, 8, 17, 21 1, 2, 8, 17, 21 103 Desinger 1, 2, 8, 17, 21 19, 20 103 Desinger, Pellegrino 19, 20 22 103 Desinger, Simpson 22 3–5, 7 103 Desinger, Levine 3–5, 7 6 103 Desinger, Levine, Simpson 6 13 103 Desinger, Sharps 13 18 103 Desinger, Rittman 18 Overall Outcome 1–8, 13, 17– 22 ORDER Accordingly, it is hereby: ORDERED that Petitioner has not demonstrated by a preponderance of the evidence that claims 1–8, 13, and 17–22 of the ’755 patent are unpatentable; and FURTHER ORDERED that, because this is a Final Written Decision, parties to this proceeding seeking judicial review of our Decision must comply with the notice and service requirements of 37 C.F.R. § 90.2. IPR2020-00895 Patent 8,882,755 B2 46 For PETITIONER: David L. Cavanaugh Mary V. Sooter Alexis Cohen WILMER CUTLER PICKERING HALE AND DORR LLP David.Cavanaugh@wilmerhale.com Mindy.Sooter@wilmerhale.com Alexis.Cohen@wilmerhale.com For PATENT OWNER: Theodoros Konstantakopoulos, Ph.D. Todd L. Krause, Ph.D. Frederick J. Ding DESMARAIS LLP tkonstantakopoulos@desmaraisllp.com tkrause@desmaraisllp.com fding@desmaraisllp.com Copy with citationCopy as parenthetical citation