Teleflex Medical Devices S.A.R.L.Download PDFPatent Trials and Appeals BoardJun 17, 2021IPR2020-00127 (P.T.A.B. Jun. 17, 2021) Copy Citation PUBLIC VERSION Trials@uspto.gov 571-272-7822 Paper Date: UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD MEDTRONIC, INC., and MEDTRONIC VASCULAR, INC., Petitioner, v. TELEFLEX INNOVATIONS S.À.R.L., Patent Owner. IPR2020-00127 Patent 8,048,032 B2 Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. SNEDDEN, Administrative Patent Judge. JUDGMENT Final Written Decision Determining Some Challenged Claims Unpatentable Granting Patent Owner’s Contingent Motion to Amend 35 U.S.C. § 318(a) PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 2 I. INTRODUCTION Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a Petition for inter partes review of claims 1–9 and 11–20 of U.S. Patent No. 8,048,032 (“the ’032 patent,” Ex. 1401). Paper 3 (“Pet.”). Teleflex Innovations S.À.R.L. (“Patent Owner”)1 filed a Preliminary Response. Paper 10 (“Prelim. Resp.”). Upon review of the parties’ arguments and supporting evidence, we instituted an inter partes review of all claims and grounds asserted in the Petition. Paper 20 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 40, “PO Resp.”) (redacted version available at Paper 41), Petitioner filed a Reply (Paper 71, “Pet. Reply”) (redacted version available at Paper 70), and Patent Owner filed a Sur-Reply (Paper 86, “Sur-Reply”) (redacted version available at Paper 87). Patent Owner also filed a Contingent Motion to Amend. Paper 82 (“MTA”). The Motion requests that if claims 1 or 12 of the ’032 patent are determined to be unpatentable, they should be replaced by proposed substitute claims 23–25 (“proposed substitute claims” or “proposed claims”). MTA 1. Petitioner filed an Opposition to the Motion to Amend (Paper 85, “Pet. MTA Opp.”), to which Patent Owner filed a reply (Paper 89, “PO MTA Reply”), and Petitioner filed a sur-reply (Paper 95, “Pet. MTA Sur-reply”). 1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into Teleflex Medical Devices S.A.R.L,” which subsequently “transferred ownership of [the ’032 patent] to Teleflex Life Sciences Limited.” Paper 7, 2. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 3 An oral hearing was held on March 8, 2021, and a transcript of the hearing is included in the record. Paper 104 (“Tr.”) (redacted version available at Paper 103). A. Real Parties in Interest Petitioner identifies its real parties-in-interest as Medtronic, Inc. and Medtronic Vascular, Inc., and notes that “Medtronic plc is the ultimate parent of both entities.” Pet. 4. Patent Owner identifies its real parties-in-interest as Teleflex Medical Devices S.À.R.L.; Vascular Solutions LLC; Arrow International, Inc.; and Teleflex LLC. Paper 4, 2. Patent Owner also notes that “Teleflex Incorporated is the ultimate parent of the entities listed above.” B. Related Matters The parties indicate that the ’032 patent is the subject of litigation in Vascular Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760 (D. Minn. filed July 2, 2019) (“Medtronic”) and QXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017). Pet. 4–5; Paper 4, 2. The ’032 patent was the subject of two previous inter partes reviews: IPR2014-00760, filed May 16, 2014 and terminated August 11, 2014 by way of joint motion to terminate, and IPR2014-00761, filed May 16, 2014 and terminated August 11, 2014 by way of joint motion to terminate. Paper 4, 2–3. Petitioner has filed a separate Petition for inter partes review of claims 1–20 and 22 of the ’032 patent as IPR2020-00126. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 4 C. The ’032 Patent 1. Specification The ’032 patent, entitled “Coaxial Guide Catheter for Interventional Cardiology Procedures,” issued on November 1, 2011, from a non- provisional application filed May 3, 2006. Ex. 1401, codes (45), (54), (22). The ’032 patent relates generally to a coaxial guide catheter for use with interventional cardiology devices that are insertable into a branch artery that branches off from a main artery. Ex. 1401, Abstract. According to the ’032 patent, interventional cardiology procedures often include inserting guidewires or other instruments through catheters into coronary arteries that branch off from the aorta. Id. at 1:15–17. In coronary artery disease, the coronary arteries may be narrowed or occluded by atherosclerotic plaques or other lesions in a phenomenon known as stenosis. Id. at 1:20–26. In treating the stenosis, a guide catheter is inserted through the aorta and into the ostium of the coronary artery, sometimes with the aid of a guidewire, and is passed beyond the occlusion or stenosis. Id. at 1:30–36. However, crossing tough lesions can create enough backward force to dislodge the guide catheter from the ostium of the artery being treated, which can make it difficult or impossible for the interventional cardiologist to treat certain forms of coronary artery disease. Id. at 1:36–40. To solve this problem, the ’032 patent describes a coaxial guide catheter that is deliverable through standard guidewires by utilizing a guidewire rail segment to permit delivery without blocking use of the guide catheter. Id. at 2:53–56. The ’032 patent teaches that the coaxial guide catheter preferably includes a tapered inner catheter that runs over a standard 0.014 inch coronary guidewire to allow atraumatic placement within the coronary artery, and this feature allows removal of the tapered inner catheter PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 5 after the coaxial guide catheter is in place. Id. at 2:57–61. Figures 1 and 2, reproduced below, show a coaxial guide catheter and a tapered inner catheter in accordance with the invention described in the ’032 patent: Figure 1 is a schematic depiction of the coaxial guide catheter and tapered inner catheter separately, and Figure 2 depicts those two elements assembled together. Id. at 5:15–21; Figs. 1 and 2. As shown above, coaxial guide catheter assembly 10 includes coaxial guide catheter 12 and tapered inner catheter 14. Id. at 6:6–8. Coaxial guide catheter 12 includes tip portion 16, reinforced portion 18, and rigid portion 20. Id. at 6:9–10. Tip portion 16 generally includes bump tip 22 and marker band 24. Id. at 6:13–14. Bump tip 22 includes taper 26 and is relatively flexible. Id. at 6:14–15. Marker band 24 is formed of a radiopaque material such as platinum/iridium alloy. Id. at 6:19–20. Tapered inner catheter tip 42 includes tapered portion 46 at a distal end thereof, and straight portion 48. Id. at 6:59–60. Both tapered portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in figures above). Id. at 6:60–61. Tapered inner catheter 14 may also include PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 6 clip 54 at a proximal end thereof to releasably join tapered inner catheter 14 to coaxial guide catheter 12. Id. at 6:64–67. In operation, the tapered inner catheter is inserted inside and through the coaxial guide catheter. Id. at 4:12–13. The coaxial guide catheter/ tapered inner catheter combination may then be inserted into a blood vessel that communicates with the aorta, and advanced until the tapered inner catheter is passed into the ostium of a coronary artery over the guidewire. Id. at 4:15–23. The tapered inner catheter may be removed once the coaxial guide catheter tapered inner catheter combination has been inserted sufficiently into the ostium of the coronary artery to achieve deep seating. Id. at 4:23–26. Once the tapered inner catheter is removed, a cardiac treatment device, such as a guidewire, balloon, or stent, may be passed through the coaxial guide catheter within the guide catheter and into the coronary artery. Id. at 4:30–33. The presence of the coaxial guide catheter provides additional backup support to make it less likely that the coaxial guide catheter/guide catheter combination will be dislodged from the ostium of the coronary artery while directing the coronary therapeutic device past a tough lesion. Id. at 4:33–39. 2. Illustrative Claims Independent claims 1 and 11, reproduced below, are illustrative of the challenged claims. 1. A device for use with a standard guide catheter, the standard guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the lumen to the branch artery, the device comprising: PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 7 a flexible tip portion defining a tubular structure having a circular cross-section and a length that is shorter than the predefined length of the continuous lumen of the guide catheter, the tubular structure having a cross-sectional outer diameter sized to be insertable through the cross-sectional inner diameter of the continuous lumen of the guide catheter and defining a coaxial lumen having a cross-sectional inner diameter through which interventional cardiology devices are insertable; and a substantially rigid portion proximal of and operably connected to, and more rigid along a longitudinal axis than, the flexible tip portion and defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion and having a length that, when combined with the length of the flexible distal tip portion, defines a total length of the device along the longitudinal axis that is longer than the length of the continuous lumen of the guide catheter, such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter. 11. A device for use with a standard guide catheter, the standard guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross-section and a cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the lumen to the branch artery, the device comprising: an elongate structure having an overall length that is longer than the predefined length of the continuous lumen of the guide catheter, the elongate structure including: a flexible tip portion defining a tubular structure having a circular cross-section that is smaller than the circular cross- section of the continuous lumen of the guide catheter and a length PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 8 that is shorter than the predefined length of the continuous lumen of the guide catheter, the flexible tip portion being sized having a cross-sectional outer diameter sized to be insertable through the cross-sectional inner diameter of the continuous lumen of the guide catheter and defining a coaxial lumen having a cross- sectional inner diameter through which interventional cardiology devices are insertable; a reinforced portion proximal to the flexible tip portion; and a substantially rigid portion proximal of and connected to, and more rigid along a longitudinal axis than, the flexible tip portion and defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion, such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter with at least proximal portion of the reinforced portion remaining within the continuous lumen of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter. Ex. 1401, 10:21–54, 11:28–12:4. D. Evidence Petitioner relies upon the following prior art references. Ex. 1409, S. B. Kontos, U.S. Patent No. 5,439,445 (issued Aug. 8, 1995) (“Kontos”). Ex. 1410, New Method to Increase a Backup Support of a 6 French Guiding Coronary Catheter, Catheterization and Cardiovascular Interventions 63: 452-456 (2004) (“Takahashi”). Ex. 1435, D. O. Adams et al., U.S. Patent Application Publication No. 2004/0010280 A1 (published Jan. 15, 2004) (“Adams”). Ex. 1451, T. A. Berg et al., U.S. Patent No. 5,911,715 (issued Jun. 15, 1999) (“Berg”). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 9 In support of its arguments, Petitioner relies on the expert declarations of Dr. Stephen Jon David Brecker (Exs. 1405, 1806, 1902), Dr. Richard A. Hillstead (Exs. 1442, 1905, 1907), Mr. Michael Jones (Ex. 1807), and Dr. Paul Zalesky (Exs. 1755, 1830, 1919). Patent Owner relies on the declarations of Ms. Amy Welch (Ex. 2044) (redacted), Ms. Deborah Schmalz (Ex. 2039), Mr. Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex. 2119), Mr. Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr. Steve Erb (Ex. 2122), Mr. Peter T. Keith (Ex. 2123, 2124, 2138, 2243), Dr. John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Mr. Steve Jagodzinkski (Ex. 2152 (redacted), 2153 (confidential)), Ms. Heather S. Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215). E. Asserted Grounds of Unpatentability Petitioner asserts that claims 1–9 and 11–20 would have been unpatentable on the following grounds. Ground Claim(s) 35 U.S.C. §2 References/Basis 1 1–7, 9, 11–16, 18, 19 103(a) Kontos, Adams 2 8, 17 103(a) Kontos, Adams 3 20 103(a) Kontos, Adams, Berg 2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the challenged claims of the ’032 patent have an effective filing date before the effective date of the applicable AIA amendments, we refer to the pre-AIA versions of 35 U.S.C. § 103 throughout this Decision. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 10 II. ANALYSIS A. Priority Date of the ’032 Patent Petitioner argues that “[t]he ’032 patent is subject to the AIA’s first- to-file provisions because it contains at least one claim that lacks a written description, and therefore, pre-AIA priority.” Pet. 14. Petitioner advances this argument to preclude Patent Owner from swearing behind the Itou reference based on a showing of prior invention, which could otherwise be done for a pre-AIA “first-to-invent” application. Id. We are not persuaded by Petitioner’s argument. The AIA’s first-to-file provisions apply to patent applications “that contain[] or contained at any time a claim to a claimed invention that has an effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The effective filing date is “the actual filing date of the patent or the application for the patent containing a claim to the invention; or the filing date of the earliest application for which the patent or application is entitled.” 35 U.S.C. § 100(i)(1). In the present case, the ’032 patent issued from an application filed May 3, 2006, and does not claim the benefit of any other filing date. Ex. 1001, code (22). Thus, the only possible effective filing date of the ’032 patent is May 3, 2006, which thus qualifies it as a pre-AIA patent.3 B. Level of Ordinary Skill in the Art We consider the asserted grounds of unpatentability in view of the understanding of a person of ordinary skill in the art (“POSITA”). Petitioner 3 Petitioner’s priority date argument appear to be a back door attempt to have us address whether the ’032 patent satisfies the written description requirement of 35 U.S.C. § 112. But this is a question we may not address in an IPR. See 35 U.S.C. § 311(b). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 11 provides two alternatives for a person having ordinary skill in the art. First, Petitioner asserts that “[i]f a person of ordinary skill in the art (‘POSITA’) was a medical doctor, s/he would have had (a) a medical degree; (b) completed a coronary intervention training program, and (c) experience working as an interventional cardiologist.” Pet. 14. Alternatively, Petitioner asserts that “if a POSITA was an engineer s/he would have had (a) an undergraduate degree in engineering, such as mechanical or biomedical engineering; and (b) at least three years of experience designing medical devices, including catheters or catheter-deployable devices.” Id. at 14–15. Additionally, Petitioner contends that “[e]xtensive experience and technical training might substitute for education, and advanced degrees might substitute for experience.” Id. at 15. Patent Owner “does not dispute Petitioner’s proposed definition of a POSITA.” PO Resp. 8. On this record, in determining whether the evidence of record supports institution, we apply both of Petitioner’s definitions for a POSITA, as they are undisputed at this time and consistent with the level of skill reflected in the prior art and the Specification of the ’032 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). C. Claim Construction We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 12 proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Petitioner proposes construction for several claimed terms, including “standard guide catheter,” “placed in a branch artery,” “flexural modulus,” “interventional cardiology devices.” Pet. 13–19. For the purpose of this Decision, we find it helpful to address the term “interventional cardiology devices.” 1. “interventional cardiology devices” Independent claims 1 and 11 of the ’032 patent recite a standard guide catheter having a continuous lumen sized “such that interventional cardiology devices are insertable into and through the lumen.” Ex. 1401, 10:26–27, 11:34–35. To that point, the Specification expressly defines the claim term “interventional cardiology devices” as follows: For the purposes of this application, the term “interventional cardiology devices” is to be understood to include but not be limited to guidewires, balloon catheters, stents and stent catheters. Id. at 1:17–21. In view of the express definition provided in the ’032 patent, in the Institution Decision we construed claims 1 and 11 to require that the coaxial lumen have a cross-sectional inner diameter through which at least two types of interventional cardiology devices (including, but not limited to guidewires, balloon catheters, stents, and stent catheters) are insertable. Inst. Dec. 19. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 13 Petitioner contends that claims 1 and 11 require that only one interventional cardiology device be insertable through the cross-sectional inner diameter of the coaxial lumen. Pet. 30, 57–58. Patent Owner contends claims 1 and 11 require that all four of the enumerated classes of devices identified in the definition of “interventional cardiology devices,” i.e., “guidewires, balloon catheters, stents, and stent catheters,” are insertable through the cross-sectional inner diameter of the coaxial lumen. PO Resp. 9–10. Patent Owner reasons that the use of the conjunctive “and,” rather than the disjunctive “or,” in the definition indicates that all of the identified “interventional cardiology devices” must be insertable through the coaxial lumen of the flexible tip portion. Id. According to Patent Owner, this conclusion is consistent with the written description of the ’032 patent because the “Summary of the Invention” section notes that the “invention has an inner diameter acceptable for delivering standard coronary devices after it is placed in the blood vessel,” and guidewires, balloon catheters, stents, and stent catheters are four of the most common coronary devices. Id. at 11 (citing Ex. 1401, 3:1–4, 5:9–12; Ex. 2145 ¶ 85; Ex. 2138 ¶ 104). In its Reply, Petitioner reiterates its position that only one interventional cardiology device need be insertable through the coaxial lumen of the tip portion, but because resolution of the question of whether one or two devices must be insertable into the lumen does not impact the outcome in this case, Petitioner asserts that “the Board can adopt its preliminary construction of ‘interventional cardiology devices’” in this proceeding. Pet. Reply 1–2. Responding to Patent Owner’s arguments, Petitioner contends that because the term “standard coronary devices” is broader than the specific set of “interventional cardiology devices” identified in the written description, the intrinsic record does not support limiting the PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 14 scope of claims 1 and 12 to require that the coaxial lumen of the tip portion have a cross-sectional inner diameter through which all four of the “interventional cardiology devices” expressly identified in the ’032 patent are insertable. Id. at 2 (citing Ex 1800, 63:20–64:1). As both parties agree, the ’032 patent expressly defines the term “interventional cardiology devices” to include, but not be limited to, “guidewires, balloon catheters, stents and stent catheters.” We understand this definition to mean that “guidewires,” “balloon catheters,” “stents,” and “stent catheters,” are each “interventional cardiology devices.” See Ex. 1401, 4:46–49 (“This discussion will refer to a guide wire but it is to be understood that similar principles apply to other interventional cardiology devices including balloon catheters and stent catheters.”). The use of the conjunctive “and” in the definition is consistent with this understanding, as all the listed devices are “interventional cardiology devices.” See id. We further understand that an individual guidewire or stent represents an “interventional cardiology device.” Pet. 27 (identifying Kontos’s PTCA catheter as an “interventional cardiology device”); PO Resp. 21 (“Thus, the PTCA catheter taught by Kontos is one ‘interventional cardiology device,’ not two.”); Ex. 1401, 4:43–46 (describing the forces in play “when a physician attempts to direct a guidewire or other interventional cardiology device past an occlusive or stenotic lesion in the branch artery”). And because a “guidewire” and “balloon catheter” are each an interventional cardiology device, as a matter of logic and grammar, to the extent both a “guidewire” and a “balloon catheter” are insertable through the cross- sectional inner diameter of the coaxial lumen, the lumen is sized to accept “interventional cardiology devices.” PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 15 As noted by Patent Owner, the ’032 patent indicates in the “Summary of the Invention” section that the “invention has an inner diameter that is appropriate for delivering standard coronary treatment devices after it is placed in the blood vessel.” Ex. 1401, 5:9–12; PO Resp. 11. The same section clarifies, however, that this is only a preference, not a requirement. Ex. 1401, 3:1–4 (“In addition, the coaxial guide catheter preferably has an inner diameter that is appropriate for delivering standard coronary treatment devices after it is placed in the coronary artery.”) (emphasis added). In addition, Petitioner persuasively explains why the terms “standard coronary treatment devices” and “interventional cardiology devices” are not co-extensive in scope. Pet. Reply 2. In view of the foregoing, we determine that use of the term “interventional cardiology devices” in claims 1 and 11 requires that the coaxial lumen of a device has a cross-sectional inner diameter through which at least two types of the devices selected from the group that includes, but is not limited to, guidewires, balloon catheters, stents and stent catheters, are insertable. For example, the cross-sectional diameter of the lumen may be sized to receive a guidewire and a stent or a balloon. Ex. 1401, 7:36–40 (“Once the guidewire 64 is pushed past stenotic lesion 66 or occlusive lesion (not shown), a treating catheter including a stent or balloon can be passed along the guidewire to stenotic lesion 66 or occlusive lesion (not shown).”).4 4 Although we construe claims 1 and 11 to require that the coaxial lumen of the tip portion is sized such that two different types of “interventional cardiology devices” are insertable, Petitioner’s construction requiring that only one type of device (e.g., “stents”) be insertable through the coaxial lumen is not without support. Ex. 1401, 4:46–49 (“This discussion will refer to a guide wire but it is to be understood that similar principles apply to other interventional cardiology devices including balloon catheters and stent PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 16 2. Other Recited Claim Terms/Phrases We determine that no express construction of any other claim term is necessary to determine whether to institute inter partes review. D. Petitioner’s Patentability Challenges 1. Ground 1: Obviousness of claims 1–7, 9, 11–16, 18, and 19 in view of Kontos and Adams Petitioner asserts that claims 1–7, 9, 11–16, 18, and 19 are unpatentable under 35 U.S.C. § 103(a) as obvious over the combination of Kontos and Adams. Pet. 17–69. For the reasons set forth below, we determine that Petitioner has not demonstrated by a preponderance of the evidence that claims 1–7, 9, 11–16, 18, and 19 would have been obvious over Kontos and Adams. a) Summary of the References Relied Upon (1) Kontos (Ex. 1409) Kontos is directed to a support catheter assembly for facilitating medical procedures and, in particular, to a catheter assembly that has “particular utility in facilitating insertion of a PTCA5 balloon into a lesion.” Ex. 1409, 1:9–13. catheters.”); Pet. 13, 27–29; Pet. Reply 1. We need not resolve this issue, however, because we find that at least two different types of interventional cardiology devices are insertable through the lumen of Kontos’s stent 10, and therefore Kontos teaches this limitation under Petitioner’s construction as well. 5 PTCA stands for “percutaneous transluminal coronary angioplasty.” Ex. 1405 ¶ 37. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 17 Figure 1 of Kontos is reproduced below: Figure 1 is a side plan view of a support catheter, “cut-away in part to show in logitudinal cross-section a tubular body having a soft tip and radiopaque marker, and a manipulating wire.” Ex. 1409, 2:51–54. As shown in Figure 1, support catheter assembly 10 is composed of two major elements, body 12 and insertion/manipulation wire 14. Id. at 3:45–46. Body 12, “which may be viewed as a mini guide catheter, includes tube 16 having a base portion 18 at its proximal end 20.” Id. at 3:47–49. “Tube 16 has a continuous lumen 22 therethrough from proximal end 20 to distal end 24.” Id. at 3:49–50. Body 12 also include a soft tip 28 disposed at distal end 24 and funnel portion 26 disposed at proximal end 20. Id. at 3:50–52. Wire 14 is attached to body 12 at base portion 18. Id. at 3:52–53. Support assembly 10 may also include distal marker band 30 and proximal marker band 32. Id. at 3:53–55. Kontos explains that the size and shape of the various elements of support assembly 10 “may vary depending on the desired application,” but in the applications depicted in Figure 1, tube 16 has a 0.055 inch outer diameter and lumen 22 has a 0.045 inch diameter. Id. at 4:46–50. According to Kontos, the sizes used in these embodiments “are generally suitable for existing PTCA catheters.” Id. at 4:61–64. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 18 Figure 5 of Kontos is reproduced below: Figure 5 is a side schematic view of a support catheter having a PTCA catheter disposed therein. Id. at 2:64–66. In this figure, PTCA catheter 40 and its deflated balloon 48 reside in lumen 22 of support assembly 10. Id. at 5:2–5. Figures 6A–6C of Kontos are reproduced below: Figures 6A–6C are cross-sectional views showing three stages in a process for guiding a PTCA catheter to a coronary artery lesion. Id. at 2:67–3:2. In Figure 6A, the PTCA catheter/support catheter assembly is fed into guide PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 19 catheter 38 and advanced to the distal end of this catheter by simultaneously exerting axial force on wire 14 and catheter tube 50. Id. at 5:25–30. In Figure 6B, when the PTCA catheter/support catheter assembly reaches the distal end of guide catheter 38, “it may be advanced as a unit out of the distal end of guide catheter 38 and into coronary ostia 39.” Id. at 5:31–35. When extending beyond the distal end of guide catheter 38, body 12 functions as a guide catheter extension protecting fragile balloon 48 and lessening “considerably the tendency of the PTCA catheter 40 to bend, buckle or kink.” Id. at 5:49–56. In Figure 6C, after body 12 has been positioned adjacent the restricted area, PTCA catheter 40 is advanced so that balloon 48 exits body 12 and is advanced into the restricted area, e.g., stenosis B. Id. at 6:9–13. Balloon 48 is then inflated, as represented by dotted lines 48, “to effect a well-known angioplasty procedure.” Id. at 6:13–15. Balloon 48 is then deflated and PTCA catheter 40, support catheter assembly 10, and guiding catheter 38 may be withdrawn. Id. at 6:15–18. (2) Adams (Ex. 1435) Adams discloses a device and method for treating vascular disease. Ex. 1435 ¶ 1. In particular, Adams discloses “a distal protection device which is deployed to filter or remove embolic debris” and “creates a seal to prevent the flow of blood during the treatment of vascular disease.” Id. ¶ 11. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 20 Figure 1A of Adams is reproduced below: Figure 1A is a side view in partial cross-section of the device of Adams. Id. ¶ 28. In this figure, Y connector 7 is attached to the proximal end of guide catheter 10 and control wire 5 passes through Y connector 7. Id. ¶¶ 59–60. To reduce blood loss, Y connector 7 has hemostasis valve 9 at its proximal end. Id. ¶ 60. As shown in Figure 1A, distal end 12 of guide catheter 10 may be inserted into the ostium “O” of coronary vessel “V,” which has a lesion “L.” Id. ¶ 59. Guide seal 20a is then deployed beyond the distal end of guide catheter 10. Id. Adams explains that in practice, a physician advances a guidewire through the femoral artery into the aorta. Id. ¶ 61. “The guide catheter is then advanced over the guidewire until the distal tip of the guide catheter is in the ostium of the vessel.” Id. The guide seal is then advanced beyond the distal tip of the guide catheter and, after some additional steps, an embolic protection device of choice may be advanced through the lumen of the guide seal and across the lesion to a point distal to the treatment site. Id. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 21 b) Discussion (1) Independent claims 1 and 11 (a) The Parties’ Arguments Petitioner contends that the combination of Kontos and Adams teaches each of the limitations of independent claims 1 and 11. Pet. 21–38 (citing Ex. 1405 ¶¶ 167–187). With regard to the “coaxial lumen having a cross-sectional inner diameter through which interventional cardiology devices are insertable” limitation of claims 1 and 11, the Petition cites the balloon catheter 40 of the Kontos device: Moreover, an interventional cardiological device, such as a PTCA catheter 40 with balloon 48 is insertable through lumen 22 of tube 16, i.e., through the “cross-sectional inner diameter” of tube 16 and body 12. Ex. 1405, ¶ 171; Ex. 1409, 4:66–5:2, Figs. 6A-C. Pet. 31; see also id. at 55–57; Ex. 1405 ¶ 227–228. To the extent that Kontos does not expressly teach or suggest both a support catheter that has a total length (flexible tip and substantially rigid portion) that is longer than the length of the continuous lumen of the guide catheter, or a proximal end that extends through a hemostatic valve in common with interventional cardiology devices, Petitioner asserts that one of ordinary skill in the art would have found both limitations obvious. Pet. 31. Petitioner reasons that in order for the physician to treat a stenosis using the device of Kontos the combined length of the support catheter must be longer than the length of the guide catheter and the proximal end must extend through a hemostatic valve. Id. at 34–35, 62 (citing Ex. 1409, 9:62– 10:15, 11:15–43. Specifically, Petitioner contends, Kontos does not disclose the length of the guide catheter, but a POSITA would appreciate that the combined length of the flexible tip portion in combination with the substantially rigid PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 22 portion is longer than the length of the guide catheter. Ex. 1405, ¶ 172 (explaining that the typical guide catheter is 100 cm14 in length, which is shorter than the combined length of the flexible tip portion and substantially rigid portion—approximately 62 inches or 157 cm—as taught by Kontos). Id. at 34. To the extent these structural limitations would not have been obvious over Kontos individually, Petitioner contends they would have been obvious in view of the additional disclosures of Adams, which discloses a device having a flexible tip portion and substantially rigid portion with a combined length that is “greater than that of the guide catheter” and that “extend proximal to the hemostatic valve 9 when the guide seal extends beyond the distal end of guide catheter 10.” Pet. 36–37, 62–63 (citing Ex. 1435 ¶ 60, Figs. A–B). Petitioner contends one of ordinary skill in the art would have sought to use the well-known aspects of interventional cardiology devices disclosed in Adams, such as relative sizes and designs, because Kontos teaches that its catheter applies “known medical procedures.” Id. at 37 (citing Ex. 1405 ¶ 175; Ex. 1409, 5:11–15). Patent Owner does not contest that one of ordinary skill in the art would have combined the identified disclosures of Kontos and Adams, but contends that Petitioner’s arguments with respect to claims 1 and 11 still fail because Petitioner has not demonstrated that at least two devices (or all four under Patent Owner’s construction of “interventional cardiology devices”) from the group that includes guidewires, balloon catheters, stents, and stent catheters are insertable into the lumen of Kontos’s support catheter. PO Resp. 20–21. Patent Owner reasons that the PTCA catheter is a single device having an integrated balloon, and not a balloon catheter and a separable balloon. Id. at 20–21 (Ex. 1409, 5:16–24 (“the relatively fragile PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 23 PTCA catheter balloon 48”), Figs. 8A–B; Ex. 2138 ¶¶ 140–141 (Mr. Keith testifying, “A balloon catheter cannot be used once the balloon becomes detached.”). Patent Owner contends also, The Petitioner has not even attempted to show that stents or stent catheters are insertable into the support catheter of Kontos—nor could it. Indeed, the only times the word “stent” appears in the Kontos reference is in describing how the support catheter of Kontos itself can function as a stent. Ex. 1409, 1:13-16, 2:13-14, 6:59-7:5; Ex. 2138, ¶ 142. Moreover, Kontos discloses that its lumen preferably has an inner diameter of 0.045 inches, while the evidence submitted by Petitioner shows that even smaller stents required a minimum guide catheter inner diameter significantly larger than 0.045 inches. Ex. 1409, 4:48-50; Ex. 1422, 3 (Cypher stent required a guiding catheter minimum inner diameter of 0.056 inches); Ex. 1423, 11; Ex. 1424, 2 (Taxus stent required a guide catheter minimum inner diameter of 0.058 inches); Ex. 2145, ¶ 150. PO Resp. 19. Petitioner argues in reply that the 0.045 inch inner diameter of support catheter 10 of Kontos is in fact sized to allow a PTCA catheter, a guidewire, a stent, and a stent catheter to travel through Kontos’s body 12. Pet. Reply 4–5 (citing Ex. 1409, 5:2–5; Ex. 1806 ¶¶ 153–154; Ex. 2138 ¶ 48; Ex. 1415, 85; Ex. 1802, 6–7, 15, 21, 25; Ex. 2116, 335:18–336:1). Patent Owner contends Petitioner’s reply arguments regarding guidewires, stents, and stent catheters are untimely, improper, and prejudice Patent Owner’s due process rights to fairly respond. Sur-Reply 7–8. Patent Owner further contends that, in the 2005–2006 timeframe, the stents identified by Petitioner still required a minimum guiding catheter diameter of 5 French, which is far larger than the 0.045 inch inner diameter of support assembly 10. Id. at 8. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 24 (b) Discussion Kontos discloses a PTCA catheter that is insertable into the lumen of tube 16, and the evidence presented by both Petitioner and Patent Owner persuasively demonstrates that a guidewire will necessarily pass through the 0.045 inch lumen of Kontos’s tube 16. Pet. 31; Pet. Reply 4 (citing Ex. 2138 ¶ 48 (Dr. Keith explaining that guidewires are typically 0.014 inches in diameter); Ex. 1806 ¶¶ 153–155). Thus, Petitioner persuasively demonstrates that “interventional cardiology devices” are insertable through the cross-sectional inner diameter of Kontos’s tube 16. We find that Petitioner’s reply arguments regarding guidewires are permissible for at least two reasons. First, Petitioner continues to rely on the same structure of Kontos as meeting the disputed claim limitation, and simply points to evidence and information that was in the record prior to the filing of its Reply to show that this structure satisfies the identified claim language even under the Board’s more restrictive construction of “interventional cardiology devices.” See Pet. 31; Pet. Reply 4; PO Resp. 13 (Patent Owner explaining that the inner diameter of Kontos’s tube 16 is 0.045 inches), 28 (asserting that the balloon catheter of Kontos has a “guidewire-like tip”); Ex. 2138 ¶ 48 (Dr. Keith explaining that the diameter of a typical guidewire used in coronary applications is 0.014 inches); see also Ex. 1409, 9:47–50 (Kontos explaining that, “[o]f course, the device of the present invention may be used with almost any type of catheter, including over-the-wire catheters as well as catheters with captive guide wires.”). Second, although Patent Owner was given an opportunity in the Sur-Reply to generally counter Petitioner’s argument that a guidewire is insertable through the inner diameter of Kontos’s lumen, Patent Owner did not take advantage of that opportunity. See Genzyme Therapeutic Prods. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 25 Ltd. P’ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1367–69 (Fed. Cir. 2016) (explaining that it is sufficient that a Patent Owner is given notice of reply arguments and an opportunity to respond to them). (c) Conclusion with Respect to Claims 1 and 11 Petitioner persuasively identifies where every limitation of claims 1 and 11 is disclosed in Kontos and Adams. Petitioner also persuasively explains why one of ordinary skill in the art would have combined Kontos and Adams to arrive at the subject matter of claims 1 and 12 with a reasonable expectation of success. Accordingly, Petitioner demonstrates by a preponderance of the evidence that claims 1 and 11 would have been obvious over Kontos and Adams. (2) Dependent Claims 2 and 12 (a) The Parties’ Arguments Claims 2 and 12 require that the device include a tubular structure that will, when its distal portion is extended beyond the distal end of the guide catheter, “assists in resisting axial and shear forces exerted by the interventional cardiology device passed through and beyond the coaxial lumen that would otherwise tend to dislodge the guide catheter from the branch artery.” Ex. 1401, 10:59–62, 12:8–11. Petitioner contends that claims 2 and 13 recite an intended use that should be afforded no patentable weight. Pet. 39 n.15. 64 n.26 (citing In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)). To the extent that the relevant claim language is limiting, however, Petitioner contends the extension catheter within the guide catheter provides “stiffer back up support” than a guide catheter alone, and when both the guide catheter and the extension catheter are inserted into a coronary ostium this will improve PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 26 distal anchoring of the system. Id. at 39–40, 64 (citing Ex. 1401, 8:18–32; Ex. 1405 ¶¶ 179, 186–187). Patent Owner argues that the functional limitations of claims 2 and 13 may not be ignored and that Petitioner fails to demonstrate that Kontos’s protective extension catheter would necessarily provide the resistance to axial and shear forces recited in claims 2 and 12. PO Resp. 24–26. According to Patent Owner, the length and type of materials used in Kontos make body 12 “more akin to a ‘wet noodle’” that one of ordinary skill in the art would not expect to provide any reinforcement in the central, narrow portion of tube 16. Id. at 24–25. Given these characteristics, Patent Owner posits that if Kontos’s extension catheter were subject to backout force it may “rotate, bend, or ‘crunch up,’ risking damage to the PTCA balloon catheter and injury to the patient.” Id. at 25 (citing Ex. 2138 ¶¶ 147–149; Ex. 2145 ¶ 147). (b) Discussion We agree with Patent Owner that the disputed claim language is a limitation and that this functional language requires a structure that “assists in resisting axial and shear forces exerted by the interventional cardiology device passed through and beyond the coaxial lumen that would otherwise tend to dislodge the guide catheter from the branch artery.” See K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1363–64 (Fed. Cir. 1999) (noting that all limitations of a claim must be given weight and that functional language may inform as to structural requirements of the claim). Petitioner and Drs. Jones and Brecker present persuasive evidence, however, that the device of Kontos will resist axial and shear forces, at least to some extent, when extended into the ostium of a blood vessel. Pet. 45 (citing Ex. 1405 ¶¶ 179, 186–187); Pet. Reply 6–10; Ex. 1806 ¶¶ 159–167; Ex. 1807 ¶¶ 14– PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 27 27, 152–158 (Dr. Jones testifying the structure and method of use of Kontos’s device would necessarily provide some level of backup support). As such, Petitioner demonstrates that the subject matter of claim 2 is disclosed in Kontos. We have considered Patent Owner’s argument, “[i]f Kontos was subjected to backout force, it may rotate, bend, or ‘crunch up,’ risking damage to the PTCA balloon catheter and injury to the patient.” PO Resp. 25 (citing Ex-2138 ¶¶ 147-149; Ex-2145 ¶ 147). Here, we note that claims do not require a particular amount of “assist[ance],”6 nor do the claims require the prevention of axial and shear forces from exerting backward force. Pet. Reply 10; Ex. 1806 ¶ 167. Thus, that Kontos may perform the “assist” function poorly as compared to the claimed device is not pertinent to our analysis as to whether Kontos discloses that feature of the claims. (c) Conclusion with Respect to Claims 2 and 12 In view of the foregoing, we determine that Petitioner has demonstrated by a preponderance of the evidence that claims 2 and 12 would have been obvious over the combined disclosures of Kontos and Adams. 6 Claims 2 and 12 state that the device assists in resisting axial and shear forces that “would otherwise tend to dislodge the guide catheter from the branch artery.” Patent Owner does not assert in its Response or Sur-Reply that this portion of the claim requires a particular quantum of assistance in resisting axial or shear forces. PO Resp. 26; Sur-Reply 11. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 28 (3) Dependent Claim 6 (a) The Parties’ Arguments Claim 6 depends from claim 1 and further requires, “the tubular structure includes a flexible cylindrical distal tip portion and a flexible cylindrical reinforced portion proximal to the flexible distal tip portion.” Ex. 1401, 11:10–13. Figure 1 of Kontos, reproduced below (annotations added by Petitioner), “is a side plan view of a support catheter of the present invention, cut-away in part to show in longitudinal cross-section a tubular body having a soft tip and radiopaque marker, and a manipulating wire.” Ex. 1409, 2:51–54. Petitioner contends that body 12 of Kontos constitutes a “flexible tip portion defining a tubular structure” and, as shown in the figure above, is composed of a “flexible cylindrical distal tip portion” and a “flexible cylindrical reinforced portion.” Pet. 49–52. According to Petitioner, the annotated figure above shows the portions of Kontos that the Petition identifies as the claimed “flexible cylindrical distal tip portion” and the claimed “flexible cylindrical reinforced portion.” Id. at 49–50. With reference to another annotated version of Figure 1, reproduced below, Petitioner contends also that one of ordinary skill in the art would PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 29 have found it obvious to reinforce tube 16 with metallic braiding/coiling, as disclosed in Adams, resulting in the following “flexible cylindrical reinforced portion” (Id. at 50–52). According to Petitioner, the figure above identifies flexible tip portion 28 as the “flexible cylindrical distal tip portion” and the remaining portion of stent 10 (body 12) as the “flexible reinforced portion.” Id. at 52. Patent Owner argues that the plain meaning of “cylindrical” is “shaped like a cylinder,” and what the Petition points to in Kontos “is not a ‘cylindrical’ shape.” PO Resp. 42 (citing Ex. 2138 ¶ 194). Instead, according to Patent Owner, body 12 of Kontos is irregularly shaped, with protruding funnel portion 26 and base portion 18 that tapers inward where the reinforcing pushwire ends. Id. Petitioner argues in response that nothing in the patent requires perfect cyclindricality and, as shown in a further annotated version of Figure 1 reproduced below, under either parties’ understanding of this claim term Kontos teaches two different flexible cylindrical reinforced portions. Pet. Reply 19–20. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 30 According to Petitioner, the annotated Figure above shows the identified “flexible reinforced portions” set forth in the Petition and the Reply. Id. at 20. Patent Owner argues in its Sur-Reply that although cylindricality need not be absolute, it does not include a structure with “distinctly asymmetric and outwardly protruding structures.” Sur-Reply 9. Patent Owner further argues that Petitioner’s new mapping of the identified claim language to cover only portions of body 12 of Kontos “is improper and the Board should disregard it.” Id. at 22–23. (b) Discussion Petitioner demonstrates, and Patent Owner does not dispute, that the portions of Kontos’s body 12 identified in Petitioner’s Reply are proximal to the flexible cylindrical distal tip portion and represent “cylindrical reinforced portions” even under Patent Owner’s understanding of claim 1. Sur-Reply 22–23. Accordingly, we determine that Petitioner persuasively demonstrates that Kontos discloses this claim limitation. Petitioner’s reply arguments are permissible because they merely note that under either parties’ understanding of the scope of claim 1, Kontos’s PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 31 body 12—the structure identified in the Petition—meets the claim limitation in question. See Apple Inc. v. Andrea Elects. Corp., 949 F.3d 697, 706–07 (Fed. Cir. 2020) (rejecting an argument that reply evidence was improper when the “reply does not cite any new evidence or ‘unidentified portions’ of the [prior art] reference”). (c) Conclusion with Respect to Claim 6 In view of the foregoing, we determine that Petitioner has demonstrated by a preponderance of the evidence that claim 6would have been obvious over the combined disclosures of Kontos and Adams. (4) Dependent Claims 3, 4, 9, 13, and 18 (a) The Parties’ Arguments Claim 3 depends from claim 2 and requires that “the proximal portion of the tubular structure further comprises structure defining a proximal side opening extending for a distance along the longitudinal axis, and accessible from a longitudinal side defined transverse to the longitudinal axis, to receive the interventional cardiology devices into the coaxial lumen while the proximal portion remains within the lumen of the guide catheter.” Ex. 1401, 11:33–40. Claims 4, 9, 13, and 18, likewise require a side opening (or otherwise recite elements defining a side opening). Id. at 11:4–6, 11:21– 24, 12:12–20, 12:39–42. Petitioner concedes that Kontos does not teach or suggest a side opening extending for a distance along the longitudinal axis, but contends such structures were well known in the art and are disclosed in Adams. Pet. 42 (citing Ex. 1405 ¶¶ 95–108, 190; Ex. 1442 ¶ 100; Ex 1407, 4:15; Ex 1408, 12:9–13:60, Fig. 6A–6E; Ex 1418, Fig. 7; Ex 1432, 119, Fig. 1; Ex 1433 ¶¶ 35, 49, Fig. 2; Ex 1435 ¶ 66; Ex 1450, Fig.7; Ex 1461, 6:9–11, Fig. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 32 1B). Petitioner asserts that one of ordinary skill in the art would have sought to modify Kontos to add a side opening at the proximal end of tube 16, as taught by Adams, for multiple reasons. First, Petitioner contends use of a proximal opening would allow for reduction of the outer diameter of the catheter assembly without a commensurate reduction in the area for the point of entry of the extension catheter. Pet. 43 (citing Ex. 1405 ¶ 193; Ex. 1442 ¶ 100). Second, Petitioner contends a proximal side opening would facilitate a “smoother” reception of the interventional cardiology device as it enters the lumen of the child catheter. Id. at 44 (citing Ex. 1408, 6:52–57; Ex. 1405 ¶¶ 196–198; Ex. 1442 ¶¶ 101–102; Ex. 1426, 3:6–9). Third, Petitioner contends a person of ordinary skill in the art would understand that a side opening would reduce the force a physician would need to exert to advance the catheter through tortuous vasculature. Id. at 45 (citing Ex. 1408, 6:52–57; Ex. 1405 ¶ 197–199; Ex. 1442 ¶ 103; Ex. 1425, Abstr., ¶ 34). Fourth, Petitioner contends a person of ordinary skill in the art would understand that a proximal side opening would permit smooth re-entry if the proximal end of the extension catheter was extended beyond the distal end of the guide catheter. Id. at 45–46 (citing Ex. 1405 ¶¶ 200–202; Ex. 1442 ¶¶ 97–99). Patent Owner contends one of ordinary skill in the art would not have made the proposed modifications to Kontos’s device for multiple reasons. First, Patent Owner argues that protruding base portion 18 and larger diameter tip portion 28 create a substantial gap between the device and the inner wall of the guide catheter, which Kontos addresses by using funnel portion 26. PO Resp. 26. According to Patent Owner, removing funnel portion 26 would make the device “worse” by exposing the gap and greatly increasing the likelihood of catching or hang-up when a device is inserted PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 33 through the catheter. Id. at 27–30 (citing Ex. 2138 ¶¶ 156–162; Ex. 2145 ¶¶ 214–217; Ex. 2137, 345:19–346:6). Second, Patent Owner argues that side openings to receive an interventional cardiology device when a device is positioned within a guide catheter were “very rare” in the art and the proximal end of Adams is only used to facilitate the collapse of the mesh when it is back-loaded into the distal end of the guide catheter, not to facilitate entry of a device at the proximal opening. Id. at 32–36 (citing Ex. 1435 ¶61; Ex. 2138 ¶¶ 165–175; Ex. 2145 ¶¶ 107–109) (asserting that only Ressemann discloses a side opening to receive an interventional cardiology device). Indeed, Patent Owner contends Adams teaches removing mesh guide seal 20 prior to advancing a treatment device to the treatment site. Id. at 32 (citing Ex. 1435 ¶ 64). Third, with respect to the purported benefit of reduced size when the funnel portion of Kontos is removed, Patent Owner argues that no size benefit would be obtained from this modification because the distal tip marker band and protruding base portion 18 would still set the outer diameter of the device, thereby preventing any decrease in size. PO Resp. 37–38. In addition, Patent Owner notes that Kontos is already sized consistent with usage in a 6 French guide catheter and, in the relevant time frame, smaller catheters were not routinely used in the art and offered no major advantage. Id. at 35–36 (citing Ex. 2167, 33; Ex. 2145 ¶ 220). Fourth, Patent Owner contends that Petitioner’s argument that a side opening would allow for smoother passage of the catheter assembly through tortuous vasculature is simply unsupported by the evidence of record, as it is the distal end of the catheter that drives the ease of advancement. Id. at 37 (citing Ex. 2138 ¶¶ 185–186; Ex. 2145 ¶ 223). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 34 Finally, Patent Owner argues that the fourth proposed motivation of permitting “smooth reentry” if the catheter were pushed entirely out of the end of the guide catheter is based on hindsight and generally contrary to what Kontos teaches. Id. at 37–38. According to Patent Owner, Kontos instructs that it is generally not desirable to extend the proximal end of body 12 beyond the distal end of the guide catheter, and all experts agree that a person of ordinary skill in the art would “never” have actually done this. Id. (citing Ex. 1409, 5:67–6:2, 6:23–28, Fig. 6B; Ex. 2116, 365:14–25, 366:22–367:5; Ex. 2137, 329:4–9; Ex. 2138 ¶¶ 109, 124, 187; Ex. 2145 ¶¶ 149, 224). Petitioner argues in reply that removing the funnel of Kontos and increasing the diameter of the catheter would maximize real estate within the catheter, which was universally understood to be advantageous. Pet. Reply 11–14. Petitioner further argues that raised marker band 30 could be recessed or embedded in the catheter, obviating the need for a raised profile. Id. at 14 (citing Ex. 1807 ¶¶ 168–182). With respect to the argument that removal of the funnel would lead to devices catching during entry into the catheter, Petitioner argues that the dimensions of Kontos demonstrate that this concern is incorrect. Id. at 16–18. According to Petitioner, the gap between the outer diameter of tube 16 and the inner diameter of the guide catheter would be 0.005 inches, whereas a guidewire, or “the distal-most wire of a fixed-wire balloon,” is typically 0.014 inches in diameter. Id. Petitioner contends these size differences demonstrate that a PTCA catheter would not catch in the gap between tube 16 and the inner wall of the guide catheter. Id. at 17–18. Finally, Petitioner argues that Ressemann expressly states that side openings facilitate smoother passage of interventional cardiology devices PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 35 and that Mr. Keith argued in a prior litigation that the funnel of Kontos contributes to a “pushability problem.” Id. at 15–16 (citing Ex. 1819 ¶ 112). In its Sur-Reply, Patent Owner argues that it is now undisputed that even with its funnel removed, Kontos’s device is still too large to fit in a 5 French guide catheter, a primary reason set forth in the Petition for making the proposed modification. Sur-Reply 12 (citing Ex. 2241, 107:8–15). Patent Owner further argues that Petitioner’s argument that removal of Kontos’s funnel and implementing a side opening would maximize the usable real estate within the guide catheter is a new argument that should not be permitted for the first time in reply. Id. at 14. To the extent Petitioner’s new arguments are considered, Patent Owner contends they are nonetheless unpersuasive. Patent Owner reasons that Petitioner provides no explanation as to how the marker bands of Kontos could be recessed and still allow for attachment of soft tip portion 28, a step which in 2005 there was no obvious way to accomplish. Id. at 14 (citing Ex. 1807 ¶¶ 168–182; Ex. 1800, 194:19–197:24). Petitioner further reasons that redesigning Kontos’s device to maximize its interior diameter is contrary to the purpose of the support catheter, which is to protect delicate fixed-wire balloon catheters and still have a small enough profile to fit inside a lesion and act as a temporary stent. Id. (b) Patent Owner’s Evidence of Objective Indicia of Non-Obviousness Objective indicia of non-obviousness, or “secondary considerations,” guard against hindsight reasoning in an obviousness analysis, and are often “the most probative and cogent evidence in the record.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016) (citations omitted). As such, objective indicia of non-obviousness must be considered in every case PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 36 in which they are presented. Id. (citing Transocean Offshore Deepwater Drilling Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012)). Objective indicia of non-obviousness include: (1) commercial success; (2) long-felt but unsolved needs; (3) failure of others; (4) copying; (5) praise in the art; (6) unexpected results; and (7) industry acceptance. Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1129 (Fed. Cir. 2000) (citing Graham, 383 U.S. at 17; Allen Archery, Inc. v. Browning Mfg. Co., 819 F.2d 1087, 1092 (Fed. Cir. 1987)). As objective indicia relevant to the challenged claims, Patent Owner presents evidence that its GuideLiner products, i.e., GuideLiner V1, GuideLiner V2, and GuideLiner V3, as a whole, solved a long-felt but unresolved need in the art, are commercially successful, were repeatedly copied by competitors, and received industry praise. PO Resp. 49–69. Patent Owner also presents evidence that the ’032 patent was licensed by a competitor. Id. at 62. Patent Owner contends this objective evidence of non-obviousness outweighs any prima facie evidence of obviousness set forth in the Petition with respect to claims 3, 9, 13, and 18. Id. at 50. (i) Commercial Success “Commercial success is relevant because the law presumes an idea would successfully have been brought to market sooner, in response to market forces, had the idea been obvious to persons skilled in the art.” Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1376 (Fed. Cir. 2005). Petitioner’s own internal documents and Patent Owner presents uncontroverted evidence that through 2019 it and its licensee (Boston Scientific) “had essentially 100% of the U.S. guide extension catheter market,” achieving PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 37 nearly in annual revenue. PO Resp. 56–58 (citing Ex. 2153 ¶¶ 2–8; Ex. 2154); Ex. 2198, 3. Petitioner does not generally dispute that Patent Owner’s GuideLiner products are commercially successful. See generally Pet. Reply 22–29. Upon review of the arguments and the evidence of record, we find that the GuideLiner products achieved a high level of commercial success. (ii) Industry Praise Evidence that the industry praised a claimed invention weighs against an assertion that the same claim would have been obvious because industry participants, especially competitors, are not likely to praise an obvious advance over the known art. WBIP, 829 F.3d at 1334. Published scientific journals and text books praise the properties of the GuideLiner products. For example, a review article in the International Journal of Cardiology states that the GuideLiner product “provides an elegant method to overcome” the problem of “severe vessel angulation and tortuosity” and has “significantly improved procedural outcomes in complex lesion anatomy and broadened the subset of lesions where PCI can be successfully performed.” Ex. 2194, 142, 147; PO Resp. 60. A technical report in EuroIntervention reports that GuideLiner allowed a stent to be “easily and successfully” deployed in a case where stent delivery was otherwise “impossible despite the use of a highly supporting guiding catheter.” Ex. 2180, 279; PO Resp. 60. In addition, a text book on catheterization procedures notes that “[l]ack of backup support can be easily overcome by using a guide catheter extension such as a Guideliner,” which “does not add complexity to the intervention and provides extraordinary backup support for complex interventions.” Ex. 2167, 182; PO Resp. 60. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 38 Petitioner does not generally dispute that Patent Owner’s GuideLiner product was praised in the industry. See generally Pet. Reply 22–29. Upon review of the parties’ arguments and the evidence of record, we find that the GuideLiner product received significant praise in the industry. (iii) Licensing Evidence that competitors or customers have licensed a patent may provide probative and cogent evidence of non-obviousness of the claims at issue. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). Patent Owner presents evidence that its competitor, Boston Scientific, licensed the GuideLiner patents PO Resp. 62 (citing Ex. 2044 ¶ 34; Ex. 2153 ¶ 8). Patent Owner also asserts that Petitioner sought a license to the GuideLiner patent portfolio. Id. (citing Ex. 2044 ¶ 21; Ex. 2068 ¶ 26). Petitioner asserts that Patent Owner’s licensing evidence is not persuasive because it has not submitted the Boston Scientific license in this case or provided any context surrounding the license, which was entered into as part of a settlement agreement. Pet. Reply 27 n.7. The mere existence of a license, without evidence that the license was entered into because of the merits of the claimed invention, is of limited probative value because it is often “cheaper to take a license than to defend infringement suits.” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir. 2004); In re Antor Media Corp., 689 F.3d 1282, 1293– 94 (Fed. Cir. 2012) (determining that the existence of licenses was insufficient because the licenses may have been entered into “as a business decision to avoid litigation, because of prior business relationships, or for other economic reasons”). Here, Patent Owner does not explain in any detail the terms of the Boston Scientific license or the circumstances under PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 39 which the license was granted, except to concede that the license was taken in settlement of litigation. See PO Resp. 62; Ex. 2044 ¶ 34. Thus, Patent Owner’s licensing efforts are of limited probative value in this case. See Iron Grip, 392 F.3d at 1324. (iv) Copying Evidence of copying of the claimed invention by a competitor, rather than one within the public domain, tends to show nonobviousness. WBIP, 829 F.3d at 1336. As discussed below, Petitioner contends its competitors copied the GuideLiner products, whereas Patent Owner contends the competing products identified by Patent Owner merely copied what was known in the prior art. Patent Owner asserts that after the introduction of the GuideLiner product “three companies launched products that not only infringed the GuideLiner patents but were close copies of then-existing versions of the commercial GuideLiner products.” PO Resp. 63. These products are Boston Scientific’s “Guidezilla” product, QXMedical’s “Boosting Catheter,” and Petitioner’s “Telescope” product. Patent Owner contends that Boston Scientific’s Guidezilla product is virtually identical to the GuideLiner V1 product. PO Resp. 63. In support of its arguments, Patent Owner provides the following annotated comparison of GuideLiner V1 and the Guidezilla product. Id. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 40 The figure above shows the general structure and length of the GuideLiner V1 and Guidezilla products. Referencing the above figures, Dr. Keith testifies that the two devices both have a flexible tube with a lumen, a rigid collar, a rigid metallic pushrod, and a handle that is marked with the device’s size. Ex. 2138 ¶¶ 232–237. When all of the elements of the two devices are considered in combination, Dr. Keith testifies that the two devices are “virtually identical.” Id. ¶ 238. Dr. Graham likewise testifies that both products are “substantially similar” and that in his clinical experience “Guidezilla functions and performs similarly to GuideLiner.” Ex. 2145 ¶¶ 261–263. Patent Owner contends that Boston Scientific confirmed the substantially similar nature of the two devices in its regulatory filings, informing regulators that Guidezilla “incorporates substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization process and intended use” as GuideLiner. PO Resp. 64–65 (citing Ex. 2138 ¶¶ 231–249; Ex. 2145 ¶¶ 261–263; Ex. 2151 ¶ 12; Ex. 2046 ¶¶ 68–79; Ex. 2200, 1). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 41 With respect to the “Boosting Catheter,” Patent Owner contends that QXMedical had access to the GuideLiner V1 and developed a “substantially similar” product. Id. at 65 (citing Ex. 2138 ¶¶ 240–249; Ex. 2196, 1). With respect to Petitioner’s Telescope product, Patent Owner contends and, as shown in the annotated figure below, Petitioner’s Telescope product is a striking copy of Patent Owner’s GuideLiner V3 product. PO Resp. 65, 69. The figure above is annotated by Patent Owner to identify the alleged similarities between GuideLiner V3 and Petitioner’s Telescope product, including a flexible tip, reinforced portion, angled opening, Half-pipe, pushrod, and rounded push tab. Id. at 66. Addressing the product’s “Half-pipe” feature, Patent Owner provides the following annotated figure showing the similarities between the half-pipe of GuideLiner V3 and the Telescope product (id. at 68). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 42 The figure above is an annotated, side-by-side comparison of the “Half- pipe” of Patent Owner’s GuideLiner V3 product and Petitioner’s Telescope product. Id. Patent Owner contends and comparison of the two devices demonstrates that “Petitioner succeeded in its efforts to copy” this feature into its Telescope product. Id. at 67–68 (Patent Owner asserting that the two products have very similar side openings and, while not quite as long, Petitioner’s half-pipe is “nonetheless quite long and (like GuideLiner V3) includes two inclined regions with a non-inclined region in between”); Ex. 2197, 1 ; Ex. 2138 ¶ 256. Petitioner argues that the elements identified by Patent Owner to establish copying of Guidezilla and the Boosting Catheter are all found in the prior art. Pet. Reply 27. In particular, Petitioner asserts that Guidezilla and the Boosting Catheter are similar to Itou and Ressemann in that they are rapid exchange devices that are “configured to deliver a wide variety of IVCDs and provide increased backup support when extended partially past a [guide catheter].” Id. Petitioner further asserts that, “[l]ike Itou and Ressemann, Guidezilla also had a side opening.” Id. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 43 With respect to its Telescope product, Petitioner contends this product simply “practices the prior art” and “[n]one of the claims for which [Patent Owner] claims nexus in this IPR pertain to its ‘half-pipe.’” Pet. Reply 28. In addition, Petitioner contends that Patent Owner “ignores the numerous unclaimed but important differences between GuideLiner and Telescope, including Telescope’s hydrophilic coating and round pushwire,” differences Patent Owner “itself emphasizes . . . as core distinguishing features” between the two products. Id. at 29 (citing Ex. 1824, 4:22–5:10). (v) Nexus To be relevant, a nexus must be established between the evidence of secondary considerations and the merits of the claimed invention. Liqwd, 941 F.3d at 1138. A presumption of nexus exists “when the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘is the invention disclosed and claimed in the patent.’” WBIP, 829 F.3d at 1329 (quoting J.T. Eaton & Co. v. ATl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997)). Dr. Keith provides unrebutted claim charts demonstrating that the GuideLiner V1, V2, and V3 products read on every limitation of claims 1, 2, 3, 9, 12, 13, and 18 of the ’032 patent. Ex. 2138, Appendix B at 1–37 (Declaration of Peter Keith). Patent Owner also persuasively ties its evidence of long-felt need, commercial success, industry praise, and copying to one or more of the GuideLiner V1, V2, and V3 products. PO Resp. 49– 68. Accordingly, a presumption of nexus applies in this case. Id. at 68–70; Ex. 2138 ¶¶ 211–212, 263, Appendix B; WBIP, 829 F.3d at 1329–30. The presumption of nexus may be rebutted by showing that the proffered objective evidence was due to extraneous factors other than the patented invention, such as additional unclaimed features or improvements PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 44 in marketing, etc. WBIP, 829 F.3d at 1329. The presumption of nexus may also be rebutted by showing that the objective evidence results from a feature that was known in the prior art. Id.; In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“where the offered secondary considerations actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.”). Petitioner argues that other than “the side opening,” which was generally known in the art, “Kontos discloses the structure of” claims 3, 9, 14, and 19. Pet. Reply 23. Petitioner further argues that all that is necessary to apply the benefits of modern guide extension catheters is rapid exchange, a side opening, and a lumen relatively close to the size of the guide catheter, and Kontos, Itou, and Ressemann all disclose rapid exchange and a lumen close in size to the guide catheter (providing backup support), and Itou and Ressemann have side openings. Id. at 24–27. As noted by Petitioner, every element of the disputed claims was individually known in the prior art. But evidence of secondary considerations may be tied to the combination of features as a whole, as opposed to one or more “novel” elements of a claimed invention. See WBIP, 829 F.3d at 1331–32. In line with this precedent, Drs. Graham, Thompson, and Azzalini persuasively testify that it was the GuideLiner devices as a whole that resulted in the evidence of secondary considerations, not any individual feature in isolation. Ex. 2138 ¶ 215; Ex. 2145 ¶¶ 71, 82, 238–241 (Dr. Graham); Ex. 2215 ¶ 22 (Dr. Thompson); see generally Ex. 2151 ¶¶ 5– 15 (Dr. Azzalini). According to these declarants, despite the fact that the individual features of the GuideLiner device were known in the prior art, including mother-and-child catheters and catheters with a side opening, devices prior to GuideLiner did not provide an effective, reliable solution to PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 45 the long standing problem of lack of backup support. Ex. 2145 ¶¶ 62–67, 82. When the various features of the prior art were combined to form the GuideLiner device, however, the result was a new, market-making, commercially successful product that provided significant benefits over prior art devices, received praise in the art, and was copied by competitors. Id. ¶¶ 76, 82; Ex. 2198, 3; Ex. 2215 ¶¶ 21–23 (Dr. Thompson testifying that the GuideLiner products “fundamentally changed the way patients were treated” and allowed him “to treat patients who otherwise would have been untreatable with a catheter procedure”); Ex. 2151 ¶ 15 (Dr. Azzalini testifying that “GuideLiner made cases possible that were previously impossible, and made cases faster, safer, and more reliable”). In view of the foregoing, we find that there is a nexus between the invention recited in claims 3, 9, 14, and 19 of the ’032 patent and Patent Owner’s evidence of long-felt but unmet need, industry praise, and commercial success. With respect to copying, we find a nexus exists for this evidence because (1) competitors had access to the GuideLiner products and produced substantially similar designs, and (2) there is direct evidence of copying of at least a portion of the GuideLiner device by Petitioner. See Liqwd, 941 F.3d at 1138 (“But where there is evidence of actual copying efforts, that evidence is always relevant.”). (c) Discussion As set forth above, the Petition provides multiple reasons why one of ordinary skill in the art would have wanted to remove the funnel of Kontos and provide an angled side opening. Patent Owner provides several arguments in response as to why the modifications suggested by Petitioner are grounded in hindsight, including the required, but previously- undescribed, recessing of raised marker band 30. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 46 Upon review of the parties’ arguments and supporting evidence, we find the parties’ arguments present a close case on the question of obviousness. For example, while side openings were known in the art, they were rare in devices intended to receive an interventional cardiology device when positioned within a guide catheter. Moreover, switching to a side opening in Kontos to beneficially increase the available real estate within the catheter or to reduce the size of the guide catheter would require several modifications to the device, at least one of which was not mentioned in the Petition and may not have been possible in the relevant time period (recessing marker band 30). In order to resolve this close case of obviousness, we look, as we always must, to Patent Owner’s evidence of objective indicia of non- obviousness. Patent Owner presents persuasive evidence that its GuideLiner products resolved a long-felt but unmet need in the art, are commercially successful, received significant praise in the industry, and were copied by competitors. Patent Owner also persuasively demonstrates a nexus between this evidence and the inventions recited in claims 3, 9, 14, and 19. Accordingly, Patent Owner’s secondary considerations evidence points strongly to the nonobviousness of claims 3, 9, 14, and 19 of the ’032 patent. In particular, we are persuaded by Patent Owner’s evidence and argument with regard to copying. Evidence of copying may take the form of “internal documents, direct evidence such as photos or patented features, or disassembly of products, or access and similarity to a patented product.” Liqwd, Inc. v. L’Oreal USA, Inc., 941 F.3d 1133, 1137 (Fed. Cir. 2019). In this case, Patent Owner persuasively demonstrates that Guidezilla, the Boosting Catheter, and Petitioner’s Telescope product were launched into the market after the relevant GuideLiner products. Thus, each competitor PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 47 had access to the GuildeLiner products. See Ex. 2200, 1; Ex. 2138 ¶ 247; Ex. 2196, 1; Ex. 2202, 1–2. Patent Owner and Dr. Keith also persuasively demonstrate that the Guidezilla and Telescope products,7 when considered as a whole, are substantially similar in design to the then-existing GuideLiner products on the market, including the combined use of a flexible tip, reinforced portion, angled opening, pushrod, and rounded push tab.8 PO Resp. 63–68; Ex. 2138 ¶¶ 231–239. As Petitioner notes, Ressemann is a rapid exchange device and has a side opening. But Guidezilla did not merely apply the idea of rapid exchange or the use of a side opening, as the device reproduces the entire combination of features that were assembled for the first time by the GuideLiner products. As such, we do not find persuasive Petitioner’s argument that Guidezilla merely copied the prior art, as opposed to the relevant GuideLiner products. Petitioner’s Telescope product differs from GuideLiner V3 in its use of a hydrophilic coating and a round pushwire, and the “half-pipe” design of the two products is not identical. Pet. Reply 28–29. We credit the testimony of Dr. Keith, however, that the overall design of the two products is 7 Patent Owner provides no figures or description comparing the Guideliner product to the Boosting Catheter. Although Dr. Keith does provide such a comparison, Patent Owner may not incorporate these materials by reference into its Response. 37 C.F.R. § 42.6(a)(3). As such, we make no findings with respect to the similarity of GuideLiner and the Boosting Catheter in this proceeding. 8 We note that Boston Scientific has not had the opportunity to refute Patent Owner’s “substantial similarity” arguments. We find only that, on this record, Petitioner has not refuted Mr. Keith’s testimony that the Guidezilla product, when considered as a whole, is substantially similar to the relevant GuideLiner V1 product. Ex. 2138 ¶¶ 240–249. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 48 substantially similar (Ex. 2138 ¶¶ 250–262), and there is little doubt that Petitioner had access to GuideLiner products and Ex. 2235, 5 , 15–17 ; Ex. 2198, 3 ; Ex. 2197, 1 ; Ex. 2069, 5. As such, the evidence of copying by Petitioner is relevant in this case and favors, at least to some extent, a conclusion of non- obviousness of the claims at issue. See Liqwd, 941 F.3d at 1138–39. (d) Conclusion with Respect to Claims 3, 4, 9, 13, and 18 Considering the close case of obviousness presented by Petitioner along with the strong objective evidence of nonobviousness presented by Patent Owner, we determine that Petitioner has not demonstrated by a preponderance of the evidence that claims 3, 9, 14, and 19 would have been obvious over Kontos and Adams. See Transocean, 699 F.3d at 1354–55. Because claim 4 depends from claim 3, and because Petitioner’s arguments with respect to this claim do not overcome the issues addressed above with respect to claim 3, we also determine that Petitioner has not demonstrated by a preponderance of the evidence that claim 4 would have been obvious over Kontos and Adams. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 49 (5) Dependent Claims 5, 7, 9, 14–16, and 19 Petitioner identifies where it contends Kontos and Adams disclose every limitation of dependent claims 5, 7, 9, 14–16, and 19. Pet. 48–49, 52– 54, 66–69. In support of these arguments, Petitioner provides a detailed analysis of the disclosures of Kontos and Adams, as well the supporting testimony of Dr. Brecker and Dr. Hillstead. Id. (citing generally Exs. 1405 and 1442). Patent Owner does not address Petitioner’s specific arguments with respect to claims 5, 7, 9, 14–16, and 19. Upon review of Petitioner’s arguments, as well as Dr. Brecker’s and Dr. Hillstead’s supporting testimony, we determine that Petitioner has sufficiently identified where each limitation of the challenged dependent claims are disclosed in Kontos and Adams. Accordingly, Petitioner has demonstrated a reasonable likelihood that claims 5, 7, 9, 14–16, and 19 would have been obvious over Kontos and Adams. 2. Ground 2: Obviousness of claims 8 and 17 in view of Kontos, Adams, and Takahashi Claims 8 and 17 depend from claims 1 and 11, respectively, and further require that the cross-sectional inner diameter of the coaxial lumen is not more than one French smaller than the cross-sectional inner diameter of the guide catheter. Ex. 1401, 11:54–57, 13:14–17. Petitioner contends these claims would have been obvious over the combined disclosures of Kontos, Adams, and Takahashi. Pet. 69–72. For the reasons set forth below, we determine that Petitioner has not demonstrated by a preponderance of the evidence that claims 8 and 17 would have been obvious over the combination of Kontos, Adams, and Takahashi. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 50 a) Summary of Takahashi Takahashi is a journal article entitled “New Method to Increase a Backup Support of a 6 French Guiding Coronary Catheter.” Ex. 1410. It bears a copyright date of 2004. Id. at 5. Takahashi discloses a “five-in-six” system wherein a 5 French guiding catheter is inserted into a 6 French guiding catheter to provide increased backup support. Id. at 452. In this system, the 5 French catheter is 120 cm in length, whereas the 6 French catheter is 100 cm in length. Id. According to Takahashi, the soft end portion of the 5 French catheter “can easily negotiate the tortuous coronary artery with minimal damage and then it can be inserted more deeply into the artery.” Id. b) Discussion Claim 8 depends from claim 1 and claim 17 depends from claim 11. Ex. 1401, 11:54, 12:35. Both claims require that “the cross-sectional inner diameter of the coaxial lumen of the tubular structure is not more than one French smaller than the cross-sectional inner diameter of the guide catheter.” Id. at 11:17–20, 12:35–38. Petitioner contends one of ordinary skill in the art would have sought to implement Takahashi’s five-in-six system in the device of Kontos and Adams because of the increased support provided by the “not-more-than- one-French differential” taught by Takahashi. Pet. 69–72. Petitioner concedes that this modification would increase the diameter of Kontos’s body, but contends this modification was well within the skill in the art, “as appropriately sized catheters were ubiquitous in the art.” Id. at 72 (citing Ex. 1442 ¶¶ 109–110; Ex. 1409, 4:64–65 (Kontos noting that “[o]f course, other sizes may be used for other applications”); Ex. 1410, 452). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 51 Petitioner further contends that, for the reasons discussed for claim 3, one of ordinary skill in the art would have had a reasonable expectation of success when removing Kontos’s funnel in favor of a proximal side opening. Id. at 71–72. Patent Owner argues that merely removing the funnel of Kontos and “making it bigger” is not enough to meet the “one French” limitation of claims 8 and 18 because Kontos’s device would still have protruding marker band structure 30 and protruding base portion 18, which would result in a greater than 1 French differential between the inner diameter of the lumen and the inner diameter of the guide catheter. PO Resp. 44. Petitioner argues in reply that one of ordinary skill in the art could simply recess Kontos’s distal marker bands and taper its pushrod for attachment onto the “Kontos-Ressemann combination,”9 which Petitioner contends would allow the diameter of tube 16 to be increased and permit Kontos to achieve the not-more-than-one-French differential of claims 8 and 18. Pet. Reply 21. Petitioner’s arguments with respect to claims 8 and 18 are premised on one of ordinary skill in the art removing Kontos’s funnel in favor of a side opening. Pet. 71–72. As discussed above with respect to claim 3, we are not persuaded that this modification to Kontos would have been obvious. Moreover, as noted by Patent Owner, the argument that one of ordinary skill in the art would recess the marker bands and modify the pushrod structure of Kontos requires significant modifications of Kontos’s device, modifications that were not proposed in the Petition. Sur-Reply 23–24; Pet. 71–72. The 9 We understand the reference to the Kontos-Ressemann combination to be a typographical error that was intended to refer to the Kontos-Adams combination. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 52 extensive need to modify Kontos’s device in a way not suggested in the Petition supports Patent Owner’s argument that the proposed modifications are based on a hindsight desire to recreate the claimed invention, as opposed to a known need in the art for such a device. Sur-Reply 23–24; Pet. 71–72. Accordingly, we determine that Petitioner has not demonstrated by a preponderance of the evidence that claims 8 and 17 would have been obvious over Kontos, Adams, and Takahashi. 3. Ground 3: Obviousness of Claim 20 in view of Kontos, Adams, and Berg Claim 20 depends from claim 19 (which depends from claim 11) and further requires that “the first flexural modulus is about 13,000 PSI plus or minus 5000 PSI, the second flexural modulus is about 29,000 PSI plus or minus 10,000 PSI, and the third portion flexural modulus is about 49,000 PSI plus or minus 10,000 PSI.” Ex. 1401, 13:29–33. Petitioner contends the subject matter of claim 20 would have been obvious over the combined disclosures of Kontos, Adams, and Berg. Pet. 73–75. For the reasons set forth below, we determine that Petitioner has demonstrated by a preponderance of the evidence that claim 20 would have been obvious over the combination of Kontos, Adams, and Berg. a) Summary of Berg Berg discloses a “guiding catheter for use in coronary angioplasty and other cardiovascular interventions.” Ex. 1451, Abstract. In particular, Berg discloses a guide catheter “having a transition zone with a different flexibility than adjacent portions of the catheter shaft for improved catheter performance.” Id. at 1:21–25. Berg notes that in order for a physician to place a catheter at the correct location in a blood vessel, the physician must apply longitudinal and PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 53 rotational forces. Id. at 1:49–51. Thus, the catheter must be rigid enough to push through the blood vessel and torsionally rigid enough to transmit the applied torque, but flexible enough to navigate the bends in the blood vessel. Id. at 1:49–56. Berg also notes that “it is preferable to have a soft tip or flexible section engage the ostium,” which provides a less traumatic section to the blood vessel. Id. at 1:63–2:4. A problem that occurs, however, is that more flexible tips may increase the incidence of guide catheter back-out, when the guide disengages from its preferred positioning in the coronary ostium. Id. at 2:11–15. Berg overcomes the deficiencies of the prior art “by providing a transition element in the material,” which “allows for flexibility of a guiding catheter to be increased, while maintaining its ability to prevent catheter back-out.” Id. at 2:35–39. Figure 19 of Berg is reproduced below: Figure 19 is a partial cross-sectional view of a distal portion of a catheter tube or guide catheter. Id. at 5:49–51. The guide catheter of Figure 19 has a plurality of discrete outer tubular member segments 140, 142, 144, 146, 148, and 150. Id. at 13:53–55. Soft tip zone 140 has a flexural modulus of “about 1 to about 15 Kpsi”; distal section zone outer tubular segment 142 has a flexural modulus of “between about 2 and about 49 Kpsi”; transition zone outer tubular segment 144 has a flexural modulus of PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 54 “between about 13 and about 49 Kpsi”; secondary curve zone outer tubular segment 146 has a flexural modulus of “greater than 49 Kpsi”; mid-shaft zone outer tubular segment 148 has a flexural modulus of “about 29 to about 67 Kpsi”; and proximal shaft zone outer tubular segment 150 has a flexural modulus of “greater than 49 Kpsi to provide maximum stiffness for push and control.” Id. at 13:66–15:6. b) Discussion Petitioner contends Berg discloses using a guide catheter having varying degrees of stiffness and that the flexural modulus for the first, second, and third portions of Berg’s catheter overlap the ranges recited in claim 20. Pet. 73–75. Petitioner further contends that one of ordinary skill in the art would have used the flexural moduli disclosed in Berg for the catheter of Kontos because Berg instructs that the disclosed combination of flexibilities allows the “flexibility of a guiding catheter to be increased, while maintaining its ability to prevent guide catheter back-out.” Id. at 74– 75 (quoting Ex. 1444, 1:36–38; Ex. 1451, 2:37–39; Ex. 1442 ¶ 118). Patent Owner argues that one of ordinary skill in the art would not have looked to the disclosures of Berg because it is directed to a guide catheter, as opposed to an extension catheter, and emphasizes that its discrete segments should be “matched to its clinical role and function.” PO Resp. 49–50 (citing Ex. 1451, 2:56–60). According to Patent Owner, these disclosures caution against importing a “one-size-fits-all” approach into different devices with different purposes and functions. Id. at 48–49 (citing Ex. 2138 ¶ 208). Petitioner argues in reply that a person of ordinary skill in the art would look to the disclosure of Berg because Kontos’s assembly and the guide catheter of Berg must navigate the same vasculature, which is the PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 55 same general “clinical role and function” of the prior art combination. Pet. Reply 22. Patent Owner does not address the combination of Kontos, Adams, and Berg in its Sur-Reply. Although the devices are not identical, we find Petitioner’s explanation persuasive as to why one of ordinary skill in the art would apply Berg’s teachings of the specific flexular modulus for each portion of the device of Kontos and Adams, i.e., because the devices must navigate the same vasculature. We are also persuaded that the flexural moduli of Berg overlap the claimed flexural moduli. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); (“[E]ven a slight overlap in range establishes a prima facie case of obviousness.”). Accordingly, Petitioner has demonstrated by a preponderance of the evidence that claim 20 would have been obvious over Kontos, Adams, and Berg. III. CONTINGENT MOTION TO AMEND Having determined that claims 1, 11, and 16 of the ’032 patent are unpatentable, we address the request to add proposed substitute claims 23– 25 as set forth in Patent Owner’s Motion to Amend. A. Legal Standard In an inter partes review, amended claims are not added to a patent as a matter of right; rather, they must be proposed as a part of a motion to amend. 35 U.S.C. § 316(d). In reviewing a motion to amend, the Board assesses the patentability of the proposed substitute claims “without placing the burden of persuasion on the patent owner.” Aqua Prods., Inc. v. Matal, 872 F.3d 1290, 1328 (Fed. Cir. 2017) (en banc); see Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, Paper 15 at 3‒4 (PTAB Feb. 25, 2019) (precedential). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 56 Notwithstanding the foregoing, a patent owner’s proposed substitute claims must meet the statutory requirements of 35 U.S.C. § 316(d) and the procedural requirements of 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4– 8. In particular, a patent owner must demonstrate: (1) the amendment proposes a reasonable number of substitute claims; (2) the proposed claims are supported in the original disclosure (and any earlier filed disclosure for which the benefit of a filing date is sought); (3) the amendment responds to a ground of unpatentability involved in the trial; and (4) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter. See 35 U.S.C. § 316(d); 37 C.F.R. § 42.121. B. Proposed Substitute Claims In its Contingent Motion to Amend, Patent Owner seeks to add proposed substitute claims 23–25 in place of original claims 1, 11, or 16, respectively. MTA 1. Proposed substitute claims 23–25 are reproduced below, with underlining indicating text added and brackets indicating text deleted from a claim. 23. A device for use with a standard 6 French guide catheter, the standard guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the lumen to the branch artery, the device comprising, in a distal- to-proximal direction: a flexible tip portion defining a tubular structure having a circular cross-section and a length that is shorter than the predefined length of the continuous lumen of the standard 6 French guide catheter, the tubular structure having a cross- sectional outer diameter sized to be insertable through the cross- sectional inner diameter of the continuous lumen of the guide PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 57 catheter and defining a coaxial lumen having a cross-sectional inner diameter of at least 0.056 inches through which interventional cardiology devices are insertable; a substantially rigid side opening that includes a first inclined region, a second inclined region, and a non-inclined concave track between the first and second inclined regions; and a substantially rigid portion proximal of and operably connected to, and more rigid along a longitudinal axis than, the flexible tip portion and defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion and having a length that, when combined with the length of the flexible distal tip portion, defines a total length of the device along the longitudinal axis that is longer than the length of the continuous lumen of the guide catheter, such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter. 24. A device for use with a standard guide catheter, the standard guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross- section and a cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the lumen to the branch artery, the device comprising: an elongate structure having an overall length that is longer than the predefined length of the continuous lumen of the guide catheter, the elongate structure including: a flexible tip portion defining a tubular structure having a circular cross-section that is smaller than the circular cross- section of the continuous lumen of the guide catheter and a length that is shorter than the predefined length of the continuous lumen of the guide catheter, the flexible tip portion being sized having PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 58 a cross-sectional outer diameter sized to be insertable through the cross-sectional inner diameter of the continuous lumen of the guide catheter and defining a coaxial lumen having a cross- sectional inner diameter through which interventional cardiology devices are insertable; a reinforced portion having a uniform, fixed cross- sectional outer diameter proximal to the flexible tip portion; [and] a substantially rigid portion proximal of and connected to, and more rigid along a longitudinal axis than, the flexible tip portion and defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion, such that when at least a distal portion of the flexible tip portion is extended distally of the distal end of the guide catheter with at least proximal portion of the reinforced portion remaining within the continuous lumen of the guide catheter, at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve in common with interventional cardiology devices that are insertable into the guide catheter; and a side opening positioned between a proximal end of the reinforced portion and a distal end of the substantially rigid portion, the side opening having a first inclined sidewall that tapers into a non-inclined concave track that is proximate a second inclined sidewall; wherein the device is configured so that, when the reinforced portion extends into the branch artery, the reinforced portion and the substantially rigid portion assist in resisting forces exerted by the interventional cardiology devices passed through and beyond the coaxial lumen that would otherwise tend to dislodge the guide catheter from the artery. 25. The device of claim 24 [[11]], wherein the reinforced portion is reinforced with metallic elements in a braided or coiled pattern, wherein the standard guide catheter is a standard 6 French guide catheter, and wherein each of the PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 59 flexible tip portion and reinforced portion has a crosssectional inner diameter greater than or equal to 0.056 inches through which the interventional cardiology devices are insertable. MTA A3–5. C. Statutory and Procedural Requirements 1. Reasonable Number of Substitute Claims A patent owner may only request substitution of a reasonable number of claims. 35 U.S.C. § 316(d)(1)(B); 37 C.F.R. § 42.121(a)(3). Patent Owner presents two substitute claims, each corresponding to one original claim. MTA A1–5. We find this one-for-one substitution is reasonable, and Petitioner does not assert otherwise. 37 C.F.R. § 42.121(a)(3) (“The presumption is that only one substitute claim would be needed to replace each challenged claim . . . .”). 2. Whether Proposed Substitute Claims 23–25 Enlarge Claim Scope or Add New Matter A proposed amendment may not seek to enlarge the scope of the claims or introduce new subject matter. 35 U.S.C. § 316(d)(3); see 37 C.F.R. § 42.121(a)(2)(ii); TurboCare Div. of Demag Delaval Turbomach. Corp. v. Gen. Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001) (“When the applicant adds a claim . . . , the new claims . . . must find support in the original specification.”). Proposed substitute claims 23–25 seek to add or reorder limitations, and do not remove any limitations. See, e.g., MTA A1– 5. Accordingly, we are persuaded that proposed substitute claims 23–25 do not enlarge the scope of the claims they replace. In its Motion to Amend, Patent Owner identifies citations in the original disclosure of Application Serial No. 11/416,629 (Ex. 1403, “the ’629 application”) that it asserts provide support for the proposed amendment of each claim. MTA 3–8 (citations omitted). Petitioner does PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 60 not argue that the substitute claims introduce new matter. See generally Pet. MTA Opp. Upon review of the citations identified by Patent Owner, we are persuaded that proposed substitute claims 23–25 are supported by the original disclosure of the ’629 application. 3. Responsive to a Ground of Unpatentability A motion to amend may be denied where it “does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner contends that the additional limitations included in proposed substitute claims 23–25 seek to further distinguish the prior art advanced in the Petition. MTA 9–20. Petitioner does not argue otherwise. See generally Pet. MTA Opp. Upon review of Patent Owner’s proposed amendments, we agree that proposed substitute claims 23–25 respond to a ground of unpatentability involved in the trial. 4. Conclusion On this record, we determine that Patent Owner’s Contingent Motion to Amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121 with respect to proposed substitute claims 23–25. D. Patentability Analysis of the Proposed Substitute Claims Petitioner challenges the patentability of proposed substitute claims 23–25 on the grounds that claims 23–25 are invalid as indefinite and also would have been obvious over the prior art of record. Pet. MTA Opp. 11– 35. We address these challenges below. 1. Indefiniteness of Proposed Substitute Claim 23–25 To satisfy the definiteness requirement of § 112, a patent’s claims must, when “viewed in light of the specification and prosecution history, PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 61 inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014). Petitioner contends proposed substitute claims 24 and 25 are indefinite because the claims recite “‘a substantially rigid portion . . . connected to . . . the flexible tip portion,’ even though the claim recites an intervening ‘reinforced portion.’” PO MTA Opp. 1 (citing MTA A3–5). Patent Owner contends Petitioner misreads claim 23, claiming it “recites a ‘substantially rigid side opening’ that is outside of both the ‘flexible tip portion’ and the ‘substantially rigid portion.’” PO MTA Reply. 11. As noted by Patent Owner, however, “the claim does not recite a separate side opening ‘segment,’ and there is no basis for requiring the side opening to be positioned outside of the substantially rigid segment.” Id. at 8 (citing Ex. 2243 ¶ 45). Regarding proposed substitute claims 24 and 25, Patent Owner responds that the term “connected to” includes both direct and indirect connections, and Petitioner’s expert “confirms ‘the specification teaches an indirect connection, such that the flexible tip portion is connected to the reinforced portion, which is connected to the substantially rigid portion.’” PO MTA Reply 8–9 (citing Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336, 1342 (Fed. Cir. 2013)). As noted by Patent Owner, however, we are directed to no disclosure or limitation in the ’032 patent that would require a direct connection, as opposed to an indirect or operable one, between the substantially rigid portion and the flexible tip portion. Indeed, the ’032 patent includes embodiments that appear to require that the flexible tip portion be indirectly connected to the substantially rigid portion and not PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 62 directly connected. PO MTA Reply 2 (citing Ex. 2243 ¶ 46; Ex. 1003, 14:7– 9, 16:12–19); Ex. 1401, 11:1–18. Accordingly, in view of the above, we do not find persuasive Petitioner’s argument that proposed substitute claims 23–25 are indefinite due to its recitation of a connection between two elements that are not physically in contact. 2. Challenges to the Proposed Claims under 35 U.S.C. § 103(a) Petitioner asserts in its Opposition that the proposed substitute claims are unpatentable on the following grounds: Claims 35 U.S.C. §10 References/Basis 23–25 103(a) Itou, 11 Ressemann,12 Kataishi13 23–25 103(a) Kontos, Ressemann, Takahashi 23–25 103(a) Kontos, Kataishi a) Obviousness of Proposed Substitute claims 23–25 over Kontos in view of Ressemann and Takahashi Petitioner contends that proposed substitute claims 23–25 would have been obvious over the combined disclosures of Kontos, Ressemann, and Takahashi. Pet. MTA Opp. 25–35. 10 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the challenged claims of the ’032 patent have an effective filing date before the effective date of the applicable AIA amendments, we refer to the pre-AIA versions of 35 U.S.C. § 103 throughout this Decision. 11 Itou et al., US 7,736,355, issued June 15, 2010 (Ex. 1407) (“Itou”). 12 Ressemann et al., US 7,604,612, issued October 20, 2009 (Ex. 1408) (“Ressemann”). 13 Kataishi et al., US 2005/0015073, published January 20, 2005 (Ex. 1425) (“Kataishi”). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 63 (1) Ressemann Ressemann is directed to an apparatus “used to prevent the introduction of emboli into the bloodstream during and after surgery performed to reduce or remove blockage in blood vessels.” Ex. 1408, 1:13– 16. Figure 1A of Ressemann, reproduced below, illustrates a first embodiment of a system for evacuating emboli from a blood vessel: Figure 1A is a cross-sectional view of a partial length evacuation sheath and depicts evacuation sheath assembly 100, which “is sized to fit inside a guide catheter” and be advanced “into a blood vessel to treat a stenosis.” Id. at 3:16–18, 6:18–24, Fig. 5A. Evacuation sheath assembly 100 includes a shaft having proximal shaft portion 110, intermediate shaft portion 120, and distal shaft portion 130 (not shown in Figure 1A). Id. at 10:30–35. Evacuation head 132 includes multi-lumen tube 138 having evacuation lumen 140 and inflation lumen 142 and is preferably made of a relatively flexible polymer. Id. at 6:35–64. Evacuation lumen 140 is preferably larger than inflation lumen 142 and “is designed to allow for the passage of interventional devices such as, but not limited to, stent delivery systems and angioplasty catheters.” Id. at 6:44–47. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 64 Proximal and distal ends of evacuation lumen 140 are angled to allow for smoother passage of evacuation sheath assembly 100 through a guide catheter and to facilitate smoother passage of other therapeutic devices through evacuation lumen 140. Id. at 6:52–57. According to Ressemann, “[t]he larger area of the angled open ends also allows for larger deformable particulate matter to pass through the lumen more smoothly.” Id. at 6:58– 60. Figure 1 B of Ressemann is reproduced below: Figure 1B is a cross-sectional view of the partial length evacuation sheath of Figure 1A, taken along line 1B-1B of Figure 1A. Id. at 3:19–20. Figure 1B shows inflation lumen 142, which has open proximal end 142a and closed distal end 142b (shown in Figure 1A) and is designed to provide fluid to inflate balloons on evacuation head 132. Id. at 6:61–64. Stiffness transition member 135 is attached to the distal end of proximal shaft portion 110, “is located co-axially in the inflation lumen 142,” and extends to soft tip 144. Id. at 11:30–39. In use, a guiding catheter is directed to a blood vessel and then a coronary guide wire is advanced to a location just proximal to the distal tip of the guiding catheter. Id. at 12:9–14. Evacuation sheath assembly 100 is PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 65 then advanced over the guide wire and positioned within the blood vessel. Id. at 12:19–21. In this process, evacuation head 132 is positioned with its distal end within the blood vessel while its proximal end remains in the guiding catheter. Id. at 12:37–39. Sealing balloons 136 and 134 are then inflated to provide a fluid seal between the sealing balloons and the blood vessel. Id. at 12:40–45. Figure 6D of Ressemann is reproduced below: Figure 6D is a cross-sectional view of the partial length evacuation sheath of Figures 1A and 1B deployed within a blood vessel. Id. at 3:59–61. As shown in Figure 6D, guidewire 170 may be advanced beyond stenosis 180 in blood vessel 150. Id. at 13:3–16. A therapeutic device, such as a stent, may then be advanced over guide wire 170 and across stenosis 180. Id. at 13:57– 60. As indicated by arrows 195, blood flow within the blood vessel is directed towards evacuation sheath 100, which “will carry any dislodged material out of the patient and into a collection chamber.” Id. at 13:35–44. Ressemann also discloses another embodiment where the “multi- lumen tube forming the evacuation head may include three lumens,” which PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 66 is illustrated in Figures 16A–16J. Id. at 22:29–33. Figure 16A, reproduced below, is a side view of a full-length evacuation sheath assembly 2100. Id. at 5:21–23. Figure 16A depicts evacuation sheath assembly 2100 having evacuation head 2132, which includes multi-lumen tube 2138 and two expandable sealing surfaces. Id. at 22:32–33, 22:40–41. Evacuation sheath assembly 2100 includes a shaft having two sections, a proximal shaft portion 2110 and an intermediate shaft portion 2120, each having distinct diameters. Id. at 27:22–36. “The proximal shaft portion 2110 provides fluid communication between an inflation apparatus (see FIG. 16I) and the intermediate shaft portion 2120.” Id. at 27:37–38. “The intermediate shaft portion 2120 includes a tapered metallic core wire 2135 inside a polymer tube 2122.” Id. at 27:51–53. Evacuation head 2132 may include a structure to reinforce the proximal opening of multi-lumen tube 2138. Id. at 24:47–49. Figure 16J, reproduced below, is an isometric view of support collar 2141 used in evacuation sheath assembly 2100. Id. at 5:46–47. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 67 Figure 16J illustrates the structure used to reinforce the proximal opening of multi-lumen tube 2138. Id. at 24:47–49. Support collar 2141 includes cylindrical portion 2141a that fits into the proximal opening of evacuation lumen 2140 allowing support collar 2141 to reinforce the proximal opening of evacuation lumen 2140 “in the presence of deforming forces, particularly torsional stresses that may be created unintentionally by rotation of the catheter shaft near its proximal end.” Id. at 24:49–58. Support collar cylindrical portion 2141a tapers into tab portion 2141b that extends proximally and in a direction parallel to a longitudinal axis of evacuation lumen 2140 to provide a flexibility transition between the proximal end of evacuation head 2131 and the shaft of evacuation sheath assembly 2100. Id. at 24:58–67. Preferably, support collar 2141 is fabricated from a thin walled metallic tube with a series of windows 2141c that “allow for some flexibility and also allow for better adhesion of the encapsulation material 2133, which covers the support collar 2141, while the cylindrical portion 2141a maintains hoop support to the proximal opening of the evacuation lumen 2140.” Id. at 25:1–8 (emphasis added). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 68 Figure 16D, reproduced below, is an enlarged cross-sectional side view of the proximal end of evacuation sheath assembly 2100 and shows the placement of support collar 2141within the structure as a whole. Id. at 5:29– 31. To facilitate attachment between evacuation head 2132 and intermediate shaft portion 2120, a distal portion of polymer tube 2122 is flared and flattened by heating with an appropriately formed mandrel. Id. at 27:59–63. As shown in Figure 16D, the “flared section is overlapped over the walls of the multi-lumen tube 2138, which define the core wire lumen 2143 and the inflation lumen 2142, as well as over the tab portion 2141b of the support collar 2141.” Id. at 27:63–67. (2) Analysis Petitioner contends that one of ordinary skill in the art would have modified Kontos’s device to include various features disclosed in PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 69 Ressemann and Takahashi to arrive at the subject matter recited in proposed substitute claims 23–25. In particular, Petitioner contends one of ordinary skill in the art would have added reinforcing metallic braiding to tube 16 of Kontos, as is disclosed in Ressemann, in order to promote pushability and prevent kinking during advancement of the catheter. Pet. MTA Opp. 32. Petitioner further contends that a person of ordinary skill in the art “would have been motivated to modify Kontos to add Ressemann’s support collar 2141” in order to optimize the inner diameter of tube 16, facilitate smooth reception of an interventional cardiology device as it enters the lumen, promote smoother passage of the catheter assembly, and permit smooth re- entry if the proximal end of the extension catheter was extended beyond the distal end of the guide catheter. Id. at 26. With respect to the relative sizes of the guiding catheter and support catheter of Kontos, Petitioner contends that a person of ordinary skill in the art would have sought to resize Kontos’s device in order to implement Takahashi’s 5-in-6 system, because Takahashi “teaches that using a catheter-in-catheter assembly—in particular, an assembly that achieves 1 French differential between the inner and outer catheters—can improve back-up support.” Id. at 29 (citing Ex. 1902 ¶ 151; Ex. 1905 ¶¶ 138–41). Petitioner contends that there would have been a reasonable expectation of success in making the proposed combination of Kontos, Ressemann, and Takahashi because a person of ordinary skill in the art “knew how to (i) replace the proximal funnel with a side opening, as discussed above, and (ii) recess Kontos’s distal marker bands.” Id. (citing Ex. 1902 ¶ 154). Petitioner’s proposed combination expressly requires modifying Kontos by: (1) removing Kontos’s funnel and replacing it with the side PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 70 opening of Ressemann (Pet. MTA Opp. 26); (2) adding metallic braiding or coiling to reinforce tube 16 of Kontos (id. at 32); (3) increasing the inner diameter of Kontos’s tube 16 from 0.045 inches to 0.059 inches (5 French) (id. at 29); (4) recessing Kontos’s distal marker bands (id.); and (5) tapering Kontos’s pushrod (id. at 30). Dr. Brecker testifies that these expressly identified modifications would also require: (1) reconfiguring Kontos’s distal soft tip 28 so that it no longer overlaps Kontos’s tube 16 (Ex. 2240, 130:19–131:2); (2) potentially resizing Kontos’s distal marker bands (id. at 131:3–134–9); (3) removing Kontos’s base portion 18 (id. at 134:24–25, 94:14–18); (4) securing Ressemann’s support collar tab 2141b on top of Kontos’s pushwire, as opposed to embedding it within the structure of the catheter (id. at 147:9–149:21); and (5) covering the “windows” in Ressemann’s collar 2141 (id. at 39:1–18, 137:5–13). The sheer number of required modifications strongly suggests that Petitioner’s proposed combination is based on hindsight, using the ’032 patent as a roadmap. Moreover, Petitioner’s proposed modifications require using Ressemann’s collar in a manner that is not disclosed in Ressemann or any other recited prior art reference, i.e., resting the tab portion of Ressemann’s collar on top of the catheter structure as opposed to embedding it within. Compare Ex. 1902 ¶ 193, with Ex. 1408, at 27:63–67, Fig. 16D; Ex. 2243 ¶ 97. Petitioner provides no persuasive explanation as to why one of ordinary skill in the art would have ignored Ressemann’s express teachings of embedding the tab portion of support collar 2141 within the structure of the catheter and instead redesigned (filled in Ressemann’s “windows”) and reoriented the tab portion to rest on the top of Kontos’s pushwire in the open space within the guide catheter. Ex. 2243 ¶¶ 97, 107 (Dr. Keith noting the lack of explanation for the unique application of the PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 71 tab portion of Ressemann’s support collar in the proposed combined device). Accordingly, we do not find Petitioner’s arguments with respect to proposed substitute claims 23–25 persuasive. In view of the foregoing, we agree with Patent Owner that Petitioner fails to adequately explain why one of ordinary skill in the art would have made the proposed combination of Kontos, Ressemann, and Takahashi. Accordingly, Petitioner has not demonstrated by a preponderance of the evidence that proposed substitute claims 23–25 would have been obvious over Kontos, Ressemann, and Takahashi. b) Obviousness of Proposed Substitute Claims 23–25 over Kontos in view of Kataishi Petitioner contends that Kataishi also discloses a “complex side opening limitation” and, “[f]or reasons similar to those discussed above . . . a POSITA would have found it obvious to replace Kontos’s flared opening with a double-inclined opening like in Kataishi.” Pet. MTA Opp. 35 (citing Ex. 1902 ¶¶ 211–217). Kataishi’s complex side opening is located at its distal tip and is used to improve suction in Kataishi’s device. Ex. 1425 ¶ 1, Fig. 10. In its single paragraph addressing this proposed ground, Petitioner provides no reasoned explanation as to why one of ordinary skill in the art would have sought to implement such a suction-improving distal tip at the proximal opening of Kontos, and Petitioner’s arguments related to Kontos and Ressemann do not address this issue. Nor does Petitioner persuasively explain why its motivations related to Itou (referenced in its Kontos-Kataishi ground) would necessarily translate to the distal opening of Kontos. In any event, Dr. Keith persuasively testifies that the distal tip of Kataishi would increase flexibility at the proximal opening of Kontos, PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 72 creating a kink point. Ex. 2243 ¶ 131 (“While increased flexibility at the distal end provides increased suction, flexibility at the proximal opening of the catheter would increase the risk of kinking.”); see also id. ¶¶ 119–132 (generally refuting Petitioner’s reasons for combining Kontos and Kataishi). We credit this testimony and, given the negative effects resulting from the importation of Kataishi’s distal opening at Kontos’s proximal opening, we find that Petitioner’s unpatentability arguments based on Kontos and Kataishi are unpersuasive. c) Obviousness of Proposed Substitute Claims 23–25 over Itou in view of Ressemann or Kataishi Petitioner contends that proposed substitute claims 23–25 would have been obvious over Itou in view of Ressemann and Kataishi. Pet. MTA Opp. 12–25. In this ground, Petitioner contends that one of ordinary skill in the art would have implemented Ressemann’s support collar at the proximal opening of Itou’s catheter. Id. at 17. Petitioner provides an annotated figure showing its proposed combination of Itou and Ressemann The figure reproduced above shows Petitioner’s proposed combination of Itou and Ressemann. Id. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 73 As shown in Petitioner’s annotated figure, Petitioner proposes to use Ressemann’s support collar 2141 in Itou in a tab-on-top configuration, with the tab portion resting on Itou’s metal pushwire. Id.; PO MTA Reply 11–12. But Petitioner again fails to explain why one of ordinary skill in the art would have ignored Ressemann’s express teachings of embedding the tab portion of support collar 2141 deep within the structure of the catheter, and instead laid the tab portion on top of Itou’s metal pushwire. See PO MTA Reply 11–12; see also id. at 13 (noting that Petitioner’s proposed combination would require at least six different modifications to the combined device). Thus, we do not find Petitioner’s reasons for combining Itou and Ressemann persuasive. Accordingly, Petitioner’s arguments with respect to the combination of Itou, Ressemann, and Kataishi are not persuasive. 3. Conclusions with Respect to Obviousness of Proposed Substitute Claims 23–25 For the reasons discussed above, we determine that Petitioner has not demonstrated by a preponderance of the evidence that proposed substitute claims 23–25 would have been obvious over Itou in view of Ressemann or Kataishi, over Kontos in view of Ressemann and Takahashi, or over Kontos in view of Kataishi. Accordingly, we grant Patent Owner’s Contingent Motion to Amend. IV. CONSTITUTIONAL CHALLENGE Patent Owner argues that the Petition should be denied because “the manner in which administrative law judges are appointed is unconstitutional.” PO Resp. 75 (citing Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320, 1325 (Fed. Cir. 2019)). Patent Owner further argues that the remedy in the Arthrex decision “severing certain removal PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 74 protections, is insufficient to cure the constitutional defect, because, e.g., it still does not give a properly appointed principle office the power to review administrative law judge decisions.” Id. (citing Lucia v. SEC, 138 S. Ct. 2044, 2055 (2018)). We decline to consider Patent Owner’s constitutional argument because the Federal Circuit addressed this issue in Arthrex. Arthrex, 941 F.3d at 1328. V. CONCLUSION14 For the foregoing reasons, we determine that Petitioner has demonstrated by a preponderance of the evidence that claims 1, 2, 5–7, 11, 12, 14–16, 19, and 20 are unpatentable as having been obvious over Petitioner’s Kontos-based grounds. Petitioner has not shown by a preponderance of the evidence, however, that claims 3, 4, 8, 9, 14, 17, and 18 are unpatentable. With respect to Patent Owner’s Contingent Motion to Amend, we determine that Petitioner has not demonstrated by a preponderance of the evidence that proposed substitute claims 23–25 would have been unpatentable as having been obvious over Itou in view of Ressemann or Kataishi, Kontos in view of Ressemann and Takahashi, or Kontos in view of Kataishi. Accordingly, Patent Owner Contingent Motion to Amend is granted. 14 Should Patent Owner wish to pursue amendment of the challenged claims in a reissue or reexamination proceeding subsequent to the issuance of this decision, we draw Patent Owner’s attention to the April 2019 Notice Regarding Options for Amendments by Patent Owner Through Reissue or Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg. 16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application or a request for reexamination of the challenged patent, we remind Patent Owner of its continuing obligation to notify the Board of any such related matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2). PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 75 In summary: The table below summarizes our conclusions as to Patent Owner’s Revised Motion to Amend the claims. Motion to Amend Outcome Claim(s) Original Claims Cancelled by Amendment Substitute Claims Proposed in the Amendment 23–25 Substitute Claims: Motion to Amend Granted 23–25 Substitute Claims: Motion to Amend Denied Substitute Claims: Not Reached VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner demonstrates by a preponderance of the evidence that claims 1, 2, 5–7, 11, 12, 14–16, 19, and 20 of U.S. Patent No. 8,048,032 are unpatentable; FURTHER ORDERED that Petitioner has not demonstrated by a preponderance of the evidence that claims 3, 4, 8, 9, 13, 17, and 18 are unpatentable; Claims 35 U.S.C. § Reference(s)/Basis Claims Shown Unpatentable Claims Not Shown Unpatentable 1–7, 9, 11–16, 18, 19 103 Kontos, Adams 1, 2, 5–7, 11, 12, 14–16, 19 3, 4, 9, 13, 18 8, 17 103 Kontos, Adams, Takahashi 8, 17 20 103 Kontos, Adams, Berg 20 Outcome 1, 2, 5–7, 11, 12, 14–16, 19, 20 3, 4, 8, 9, 13, 17, 18 PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 76 FURTHER ORDERED that Patent Owner’s Contingent Motion to Amend U.S. Patent No. 8,048,032 to add proposed substitute claim 43 and 44 is granted; 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. PUBLIC VERSION IPR2020-00127 Patent 8,048,032 B2 77 FOR PETITIONER: Cyrus Morton Sharon Roberg-Perez Christopher Pinahs William E. Manske Emily J. Tremblay ROBINS KAPLAN LLP cmorton@robinskaplan.com sroberg-perez@robinskaplan.com cpinahs@robinskaplan.com wmanske@robinskaplan.com etremblay@robinskaplan.com FOR PATENT OWNER: Derek Vandenburgh Dennis Bremer CARLSON, CASPERS, VANDENBURGH & LINDQUIST, P.A. dvandenburgh@carlsoncaspers.com dbremer@carlsoncaspers.com PUBLIC VERSION Copy with citationCopy as parenthetical citation