Ex Parte Fischer et alDownload PDFPatent Trial and Appeal BoardNov 14, 201713744696 (P.T.A.B. Nov. 14, 2017) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. PA-7128-RFB 9784 EXAMINER IGBOKO, CHIMAU ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 13/744,696 01/18/2013 90981 7590 11/14/2017 Cook Medical Technologies LLC c/o Liell & McNeil Attorneys PC P.O. Box 2417 511 S. Madison Street Bloomington, IN 47402 Frank Fischer 11/14/2017 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FRANK FISCHER and KURT TEKULVE Appeal 2017-000787 Application 13/744,6961 Technology Center 3700 Before FRANCISCO C. PRATS, JOHN G. NEW, and KRISTI L. R. SAWERT Administrative Patent Judges. SAWERT, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the rejection of claims 1—3 and 5—13. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify COOK MEDICAL TECHNOLOGIES LLC the real party in interest. Appeal Br. 2. Appeal 2017-000787 Application 13/744,696 STATEMENT OF THE CASE Claims 1—3 and 5—13 are on appeal. Claims 1—3 and 5—7 stand rejected as unpatentable under 35 U.S.C. § 103(a) for obviousness over Petrick2 in view of Griego.3 Ans. 2. Claims 8—12 stand rejected as unpatentable under 35 U.S.C. § 103(a) for obviousness over Petrick in view of Griego and Olson.4 Id. Claim 13 stands rejected as unpatentable under 35 U.S.C. § 103(a) for obviousness over Petrick in view of Griego and Olson, and further in view of Macaulay.5 Id. Claim 1 provides: 1. A lumen re-entry system, comprising: a helically wound coil having an open proximal end and an open distal end and defining a longitudinal movement axis, wherein the helically wound coil includes a relaxed distal segment that is relaxed relative to a proximal segment of the helically wound coil, and a number of turns per unit length of the helically wound coil in the relaxed distal segment being less than the proximal segment; a tip deflection wire attached to the relaxed distal segment and coaxially disposed relative to the helically wound coil, wherein movement of the tip deflection wire in a proximal direction moves the lumen re-entry system from an advancement configuration in which the open distal end of the helically wound coil is substantially aligned with the 2 Timothy B. Petrick et al., U.S. Patent Publication No. 2005/0049574 A1 (Mar. 3, 2005) (“Petrick”). 3 John A. Griego and Matthew Whitney, U.S. Patent Publication No. 2005/0124912 Al (Jun. 9, 2005) (“Griego”). 4 Matthew Jonathan Olson et al., U.S. Patent No. 8,337,425 B2 (Dec. 25,2012) (“Olson”). 5 Patrick Macaulay and Asha Nayak, U.S. Patent No. 8,214,015 B2 (Jul. 3, 2012) (“Macaulay”). 2 Appeal 2017-000787 Application 13/744,696 longitudinal movement axis to a deflected configuration in which the open distal end of the helically wound coil is deflected relative to the longitudinal movement axis; and a puncture wire slidably received within the helically wound coil and having a distal puncture tip configured to puncture through a vascular wall. Appeal Br. 13. Claim 8 provides: 8. A method of re-entering a lumen of a patient vessel using a lumen re-entry system, the lumen re-entry system including a helically wound coil having an open proximal end and an open distal end and defining a longitudinal movement axis, wherein the helically wound coil includes a relaxed distal segment that is relaxed relative to a proximal segment of the helically wound coil, and a number of turns per unit length of the helically wound coil in the relaxed distal segment being less than the proximal segment, a tip deflection wire attached to the relaxed distal segment and coaxially disposed relative to the helically wound coil, and a puncture wire slidably received within the helically wound coil and having a distal puncture tip configured to puncture through a vascular wall, the method comprising steps of: advancing the helically wound coil through a wall of the patient vessel with the open distal end of the helically wound coil substantially aligned with the longitudinal movement axis; deflecting the open distal end of the helically wound coil relative to the longitudinal movement axis and toward the lumen by moving the tip deflection wire in a proximal direction; and entering the lumen by advancing the puncture wire distally beyond the open distal end of the helically wound coil and penetrating the wall using the distal puncture tip. Id. at 14. 3 Appeal 2017-000787 Application 13/744,696 DISCUSSION We have reviewed Appellants’ arguments in the Briefs, the Examiner’s final Office Action, and the Examiner’s Answer to the Appellants’ arguments. Upon review of the record, we find that the Examiner did not establish, by a preponderance of the evidence, that the claimed invention would have been obvious over the combined prior-art references. For this reason, we reverse the rejection of the claims 1—3 and 5-13 under 35 U.S.C. § 103. Background The claimed invention is directed to a lumen re-entry system comprising a helically wound coil having a tip deflection wire and a puncture wire. Spec. 1—3 (|| 2, 7). The Specification states that the lumen re-entry system is useful for treating blockages within the vascular system that obstruct blood flow—known in the art as a chronic total occlusion (CTO). Id. at 1 2—3). The Specification explains that the lumen re-entry system works by advancing the helically wound coil through the wall of a patient’s blood vessel and then re-entering the lumen of the blood vessel by moving the coil towards the lumen via the tip deflection guide wire, and then penetrating the vessel wall using the puncture wire. Id. at 3 (| 8). An embodiment of the lumen re-entry system is illustrated in Figure 1, reproduced here: 4 Appeal 2017-000787 Application 13/744,696 Fig. 1 is a sectioned side diagrammatic view of a lumen re entry system. Spec. 3 (19). As shown in Figure 1, the lumen re-entry system 10 comprises a helically wound coil 14 having an open proximal end 16 (i.e., the end closest to the clinician) and an open distal end 18 (i.e., the end farthest away from the clinician). Spec. 5 (12). The coil also comprises a distal segment 30 and a proximal segment 32. Id. at 6 (1 5). The Specification explains that the distal segment is “relaxed” compared to the proximal segment 32, and is typically shorter than the proximal section. The relaxed distal segment provides increased flexibility toward the open distal end of the coil so as to allow turns. Id. Figure 1 also shows a tip deflection wire 34 attached to the relaxed distal segment. Id. at 6—7 (1 6). In one embodiment, the tip deflection wire has a distal end 36 connected to the helically wound coil, with a proximal end 38 extending outside the proximate end of the coil. Id. The lumen re entry system also comprises a puncture wire 42 having a distal puncture tip 44, “that may be slidably received within the helically wound coil.” Id. at 8 (19). Specifically, the puncture wire “is adapted and sized to be inserted through the helically wound coil.” Id. The Specification explains that the 5 Appeal 2017-000787 Application 13/744,696 puncture wire functions to puncture “through a vascular wall using the distal puncture tip.” Id. Figures 4—6 show the use of the lumen re-entry system in a percutaneous vascular procedure: Figs. 4—6 are side diagrammatic views of the vascular structure of a patient at different stages of the lumen re-entry procedure. Spec. 4 at 4 (H 12-14). The vascular structure 70 includes a vessel wall 72 surrounding the lumen 74. Id. at 10 (| 14). The Specification explains that a clinician may advance the helically wound coil past the occlusion 78 in a longitudinal 6 Appeal 2017-000787 Application 13/744,696 direction through the subintimal space of the vessel wall. Id. (115); Fig. 4. Then, by moving the tip deflection wire 34 in the proximal direction, the clinician “deflects” the distal end of the helically wound coil toward the lumen. Id. at 11 (1 16); Fig. 5. The clinician may cause the helically wound coil to enter or re-enter the lumen by advancing the puncture wire 42 through the open distal end of the helically wound coil, and puncturing the vessel wall with the puncture tip 44. Id. (117). The Specification further explains that, once the puncture tip has punctured the vessel wall, the clinician may retract the puncture wire and advance the wire guide 76 through the helically wound coil through the puncture and into the lumen. Id.', Fig. 6. Then, the helically wound coil may be advanced over the wire guide back into the lumen. Id. at 10 (114). The Examiner rejected representative claim 1 for obviousness over Petrick in view of Griego. Final Act. 2-4. The Examiner relied on Petrick to teach most elements of claim 1, including “a distal puncture tip capable of puncturing through a vascular wall.” Id. at 3 (citing Petrick H 60-61). The Examiner acknowledged that Petrick fails to teach “a number of turns per unit length of the helically wound coil in the relaxed distal segment being less than the proximal segment,” as recited in claim 1. Id. For this teaching, the Examiner relied on Griego, which the Examiner found teaches a helically wound coil having a relaxed distal segment with less turns per unit length than the proximal segment. Id. (citing Griego 181). The Examiner reasoned: Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Petrick to have a number of turns per unit length of the helically wound coil in the relaxed distal segment being less 7 Appeal 2017-000787 Application 13/744,696 than the proximal segment, as taught by Griego. Doing so would provide a greater flexibility to the distal portion relative to the remaining portion of the shaft. Id. (citing Griego 181). Petrick discloses a catheter comprising an elongate tubular member having a deflectable tip, made of helical coils, located at the distal end of the member. Petrick 1 8. Petrick teaches that the catheter may further comprise a lumen that extends from the proximal end to the distal end of the elongate tubular member, and that is “adapted to slideably receive a guidewire.” Id. 110. Petrick teaches that the “guidewire is advanced through the lumen of the catheter and into the lesion to cross the lesion.” Mill. As shown in Figures 7B—D of Petrick, the clinician moves the catheter 10 through an artery 90 toward the occlusion 91. Petrick 1 61; Fig. 7B. Then, the clinician operates the control wire to direct the deflectable tip 11 toward the occlusion. Id.-, Fig. 1C. The guidewire 101 is then used to advance through the lumen of the catheter and into the occlusion, thereby crossing the lesion. Id.- Fig. 7D. Figs. 7B—D are cross sectional views of an occluded vessel showing a guidewire and catheter crossing the occlusion. Petrick H 43^44. 8 Appeal 2017-000787 Application 13/744,696 As noted above, the Examiner relied on Petrick’s disclosure of a guidewire as teaching most elements of claim 1, including a “puncture wire slidably received within the helically wound coil and having a distal puncture tip capable of puncturing through a vascular wall.” Final Act. 3 (citing Petrick H 60—61). In determining that Petrick’s guidewire was “capable of’ puncturing through the vascular wall, the Examiner reasoned that Petrick does not affirmatively state that the guidewire cannot be configured to puncture the vessel wall, or that the guidewire is incapable of doing so. Ans. 4. The Examiner also reasoned that “configured to” merely recited the intended use of the claimed lumen re-entry system, and that “whether it is the medical practitioner’s goal or not, a guidewire is capable of puncturing a vessel.” Id. As to the latter, the Examiner pointed to the background discussion in Petrick, which states that “[a] guidewire having insufficient support or rigidity to enter the lesion will bend or, in some cases, perforate the vessel at the bifurcation.” Id. (citing Petrick | 6). Discussion The dispositive issue in this case, as Appellants point out, is whether the Examiner properly rejected the claims over prior art “capable of’ achieving—but not “configured to” achieve—the purpose of the claimed lumen re-entry system’s puncture wire. See Appeal Br. 5—7. Put differently, is it sufficient for obviousness that Petrick’s guidewire is “capable of’ puncturing through a vascular wall? We determine that it is not. Claim 1 specifically requires that the lumen re-entry system’s puncture wire has a puncture tip “configured to puncture through a vascular wall.” Appeal Br. 13 (claim 1). As explained above, the Examiner gave 9 Appeal 2017-000787 Application 13/744,696 little to no weight to the “configured to” language, asserting that it merely recited the intended use of the claimed lumen re-entry system. Ans. 4. That was in error. The Federal Circuit has held that “configured to” is analogous to “made to,” “adapted to,” and “designed to.” In re Man Mach. Interface Techs. LLC, 822 F.3d 1282, 1286 (Fed. Cir. 2016). Based on the claim language and the Specification, we find that “configured to” has a narrower meaning than “capable of.” Specifically, we find that a person of ordinary skill in the art would understand that the claimed puncture wire is specially designed to accomplish a specific purpose: to puncture through a vascular wall. See Asp ex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335, 1349 (Fed. Cir. 2012) (using the terms “designed to” and “configured to” as “to accomplish a specific purpose”); see also In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014) (accord). The Specification explains that the puncture wire of the claimed lumen re-entry device is specifically designed to allow the helically wound coil to either enter the subintimal space of a vessel wall from the lumen, or to exit the subintimal space into the lumen. Spec. 3 (1 8), 11 (117). The Specification further explains that the puncture wire “is used only when the helically wound coil 14 has been properly positioned and moved into the deflected configuration, thus minimizing the risk of inadvertently puncturing or tearing vessel walls.” Id. at 12 (| 20). The Specification states that once the puncture tip has punctured the vascular wall, the puncture wire may be retracted or withdrawn from the helically wound coil. Id. at 12 (| 19). The Specification also states that the puncture wire must “be stiff enough to provide sufficient force for puncturing through a vasculature wall using the distal puncture tip.” Id. at 8 (19). Indeed, the Specification stresses that 10 Appeal 2017-000787 Application 13/744,696 “[according to all embodiments,” the puncture tip “is configured to puncture through a vasculature wall,” and specifically “may include a sharp needlepoint.” Id. (110) (emphasis added). In contrast, Petrick’s guidewire is not configured to puncture a vascular wall. Petrick teaches away from such a use by explaining the difficulties associated with the mistaken perforation of a vessel with a guidewire. Petrick | 6. Petrick also specifically teaches orienting the guidewire so that it “is both parallel and centered within the lumen of the vessel.” Id. 161. And, as Appellants persuasively add, Petrick’s catheter is “for controlling a guidewire is used to cross a chronic total occlusion in a blood vessel,” Petrick 11, and therefore is about avoiding wire guide buckling and misdirection that could puncture a vessel wall, Appeal Br. 7. In summary, we find that the Examiner’s rejection is based on the capability of using Petrick’s guidewire as a puncture wire, instead of whether it would have been obvious to modify Petrick’s guidewire to be “configured to puncture through a vascular wall.” “Physical capability alone does not render obvious that which is contraindicated.” Giannelli, 739 F.3d at 1380. Thus, we reverse this rejection. The remaining rejections Because the remaining rejections rely on Petrick as the primary reference, we reverse the rejection of claims 8—12 over Petrick in view of Griego and Olson, and of claim 13 for obviousness over Petrick in view of Griego and Olson, and further in view of Macaulay for the same reasons. 11 Appeal 2017-000787 Application 13/744,696 SUMMARY We reverse the rejection of claims 1—3 and 5—13 under 35 U.S.C. §103. REVERSED 12 Copy with citationCopy as parenthetical citation