Matthew J. Olson et al.Download PDFPatent Trials and Appeals BoardOct 23, 201913719687 - (D) (P.T.A.B. Oct. 23, 2019) 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. 13/719,687 12/19/2012 Matthew J. Olson 1001.3061102 2159 11050 7590 10/23/2019 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER CERIONI, DANIEL LEE ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 10/23/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MATTHEW J. OLSON, CHAD J. KUGLER, ROSS A. OLSON, DAVID B. ROBINSON, and PETER A. JACOBS __________ Appeal 2018-004558 Application 13/719,687 Technology Center 3700 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellant1 submits this appeal under 35 U.S.C. § 134 involving claims to an elongate medical device for penetrating tissue. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Bridgepoint Medical, Inc., which Appellant states is a wholly-owned subsidiary of Boston Scientific Corporation. Appeal Br. 3. Appeal 2018-004558 Application 13/719,687 2 STATEMENT OF THE CASE Appellant’s invention “relate[s] to devices and methods for crossing chronic total occlusions and establishing a pathway blood flow past the chronic total occlusions.” Spec. ¶ 2; see also id. Figs. 19–20 (showing reentry device (180) crossing occlusion (36) in an arterial lumen (30)). Appellant’s figures help to illustrate features of the invention and the medical device claimed. Figure 24, for example, is reproduced below. Spec., Fig. 24. Figure 24 is a partial cross-sectional view of an example re- entry medical device (580). This figure shows, inter alia, that the device includes a shaft (540), i.e., a proximal segment, a first tapered section (552), and a distal segment (560), which terminates in a distal portion and “probe” (546) “that extends beyond distal surface [544]” of a tip member (542) by distance “L.” Spec. ¶¶ 79–80. Figure 24 further shows a coil (548) that is positioned around distal segment (560), which coil, in this embodiment, is “fixed to first tapered section 552 at a joint 566.” Id. ¶ 79 (“Joint 566 and tip member 542 may comprise, for example, silver (e.g., silver solder and/or silver braze). Joint 566 and tip member 542 may be formed using various manufacturing processes (e.g., soldering, brazing, and welding).”). Appeal 2018-004558 Application 13/719,687 3 Claims 1–20 are on appeal. Independent claim 1 is illustrative, and reads: 1. An elongate medical device for penetrating tissue, comprising: an elongate shaft having a proximal segment and a reduced diameter distal segment, the distal segment unitarily formed with the proximal segment; a coil positioned around the distal segment; a tip member fixedly securing a distal end of the coil to the distal segment; and a distal portion of the distal segment extending distal of the distal end of the coil and extending distal of a distalmost end of the tip member; wherein the distal portion of the distal segment defines a probe adapted and configured to pierce tissue. Appeal Br. 19 (Claims App’x). The other independent claim, claim 12, is similar to claim 1. Rather than a “coil,” claim 12 recites “a tubular component positioned around and fixedly secured to the distal segment of the elongate shaft.” Appeal Br. 21. Claim 12 also recites, inter alia, “a distal portion of the distal segment extending distal of a distal end of the tubular component and forming a probe adapted and configured to pierce tissue,” and requires “the probe being exposed from all other components . . . and defining a distalmost end of the elongate medical device.” Id. Appeal 2018-004558 Application 13/719,687 4 The claims stand rejected under 35 U.S.C. § 103(a) as follows: I. Claims 1–4, 8, 9, 12, 13, 17, and 18 over Eskuri2 and Venbrux.3 Final Act. 4–10. II. Claims 5–7 and 14–16 over Eskuri, Venbrux, and Terashi.4 Final Act. 10–11. III. Claims 10, 11, 19, and 20 over Eskuri, Venbrux, and Khairkhahan.5 Final Act. 11–13. All three rejections rely on the combination of Eskuri and Venbrux in support of the Examiner’s conclusion that independent claims 1 and 12 would have been obvious. For the reasons explained below, we determine that the preponderance of the evidence cited by the Examiner does not support the Examiner’s conclusion that claims 1 and 12 would have been obvious over Eskuri and Venbrux. 2 Eskuri, US 2008/0097247 A1, published Apr. 24, 2008. 3 Venbrux et al., US 2007/0191778 A1, published Aug. 16, 2007. 4 Terashi et al., US 2007/0088230 A1, published Apr. 19, 2007. 5 Khairkhahan et al., US 2006/0009715 A1, published Jan. 12, 2006. Appeal 2018-004558 Application 13/719,687 5 OBVIOUSNESS OVER ESKURI AND VENBRUX Claims 1 and 12 The Examiner, relying primarily on Fig. 2 and related description in Eskuri, finds that Eskuri discloses several of the features of the medical device of claim 1. Final Act. 4–5. Eskuri’s Fig. 2 is shown below. Eskuri, Fig. 2. Figure 2 above is a partial cross-sectional view of Eskuri’s guidewire (10) for crossing an occlusion in a blood vessel. Id.; see id. at Abstract, ¶¶ 11–12, 28. According to the Examiner, as depicted in Fig. 2, Eskuri discloses an elongate device having a proximal segment (42), a reduced diameter distal segment (40), a coil (60)6 around the distal segment, and a tip member (32) fixedly securing a distal end of the coil to the distal 6 Eskuri describes structure 60 as a “thread member,” such as one forming a “screw-like pattern with multiple threads,” which threads “engage the occlusion in a screw-like, auger-like, and/or threaded-like manner and draw and/or pull the guidewire 10 into occlusion 80.” See, e.g., Eskuri ¶¶ 38, 40, Figs. 3–5 (showing guidewire being drawn through occlusion 80 by a rotating action of the guidewire). Appeal 2018-004558 Application 13/719,687 6 segment. Final Act. 4 (“Examiner’s Note: item 32 is attached to items 30 and 20 and item 60 can be a monolithic, one piece with item 20.”). The Examiner finds that Eskuri does not, however, disclose “a distal portion of the distal segment extending distal of the distal end of the coil and extending distal of a distalmost end of the tip member,” or that “the distal portion of the distal segment defines a probe adapted and configured to pierce tissue” as recited in claim 1. Final Act. 4. The Examiner, thus, turns to Venbrux. The Examiner finds that Venbrux teaches a medical device— particularly a device as shown in Fig. 2B—with the claimed features missing in Eskuri. Id. at 5. Venbrux’s Figs. 2A and 2B are reproduced below. Venbrux, Figs. 2A, 2B. Figures 2A and 2B are, respectively, enlarged, cross-sectional views of a guide wire (10) having a core wire (20) in retracted (Fig. 2A) and extended (Fig. 2B) positions. Venbrux ¶¶ 51, 55.7 According to the Examiner, Venbrux’s anchoring portion (42) with tine (56) 7 Venbrux teaches that the core wire (20) may be extended or retracted through aperture (52) by an actuating mechanism (e.g., a plunger or syringe- like feature) coupled to the wire. See, e.g., Venbrux ¶¶ 55–58, Fig. 1 (showing plunger shaft 55 at the device’s proximal end). Appeal 2018-004558 Application 13/719,687 7 in Fig. 2B satisfies claim 1’s distal portion of a distal segment that extends distal to a coil and is a “probe” configured to pierce tissue. Final Act. 5. The Examiner concludes it would have been obvious to combine the cited features of Eskuri and Venbrux and arrive at the subject matter of claim 1. Final Act. 5. Specifically, the Examiner reasons that the ordinarily skilled person would, in view of Venbrux, have modified Eskuri’s medical device to include a probe with the features of claim 1 (e.g., distal portion of the distal segment extending distal of a distalmost end of the tip member, and configured to pierce tissue) to “increas[e] the ability of Eskuri’s device to penetrate through occlusions by adding a sharp tip to the front of the device so that the device works similar to a screw-type fastener.” Id. The Examiner makes similar findings, citing the same disclosures in the art, and provides substantially the same reasoning in support of the rejection of claim 12 over Eskuri and Venbrux. Final Act. 7–9. The Examiner’s proposed changes to the prior art are summarized in the modified drawings below, reproduced from the Examiner’s Answer. Appeal 2018-004558 Application 13/719,687 8 Ans. 14. The above drawings show Fig. 2 of Eskuri, Fig. 2B of Venbrux, and a third figure that purports to combine features from Eskuri’s Fig. 2 and Venbrux’s Fig. 2B to produce a modified medical device meeting all the limitations of claim 1 (and 12). Appellant argues the combination of Eskuri and Venbrux fails to teach or suggest the claimed medical device. Appeal Br. 11–13. Appellant contends that “neither Eskuri nor Venbrux discloses an elongate member having a distal segment that is fixedly secured to a coil or tubular member and that extends distal of a distal end of the coil or tubular member.” Appeal 2018-004558 Application 13/719,687 9 Appeal Br. 12. According to Appellant, when Venbrux is considered in its entirety, it describes a core wire/anchoring portion that is movable between a first (retracted) position and a second (extended) position. Id. at 11–12. Hence, Appellant urges, Venbrux’s anchoring portion—the alleged distal portion of the distal segment and “probe”—is not “fixed” to the “coil” or “tubular member” of the device in the manner claimed. Id. at 12–13. Conversely, Appellant contends, “Eskuri discloses a core member that is fixed to a tubular member such that the core wire does not extend distally of a coil or tubular member and is not configured to pierce tissue.” Id. at 14. Moreover, Appellant contends, the teachings in Venbrux cut against the Examiner’s proposed modification where a sharp tip becomes fixed in place and forms the distalmost end of the medical device. Id. at 13–14. As Appellant notes, Venbrux teaches that the purpose of having its sharp anchoring portion/tip be movable between a retracted and extended position is to “avoid undesirable and/or premature engagement between the anchoring portion 42 and the body vessel.” Id. at 13 (quoting Venbrux ¶ 55). So, Appellant argues, the ordinarily skilled person “would not have modified the fixed core member 30 of Eskuri” as proposed “because Venbrux expressly discloses the core wire 20 should be movable and not always extend distally of an end of an end cap,” to avoid undesirable piercing of, for example, the wall of a blood vessel by the sharp anchor/tip. Id. at 13–14; Reply 4–5. We agree with Appellant that claims 1 and 12 would not have been obvious over Eskuri and Venbrux on the record before us. Considering Appeal 2018-004558 Application 13/719,687 10 Eskuri and Venbrux as a whole, we are unpersuaded the ordinarily skilled person would have modified the prior art in the manner proposed. On balance, we agree with Appellant that Venbrux’s teachings undermine the Examiner’s reasoning and would have discouraged modifying Eskuri’s distal segment as proposed to become a sharp tip in a fixed position at the distalmost end of Eskuri’s guidewire. Venbrux’s design provides an on-demand feature, where the sharp anchoring tip is retracted during deployment and extended only when desired, at the desired position in a body vessel. See, e.g., Venbrux, Abstr., ¶¶ 55 (describing the retracted position as “avoid[ing] undesirable and/or premature engagement between the anchoring portion 42 and the body vessel”), 61 (“the core wire 20 is in the retracted position . . . to avoid snagging or becoming anchored to an inner wall . . . of the body vessel.”). Modifying the art in the way proposed would introduce a feature that Venbrux discloses is a noted disadvantage in analogous wire guide devices. Similar to Venbrux, Eskuri’s device is designed for passage through portions of a subject’s vasculature to reach a target region, and Eskuri discloses that such passages “may be very tortuous.” Eskuri ¶ 3 (“The path taken within the anatomy of a patient may be very tortuous, and as such, it may be desirable to combine a number of performance features in the intravascular device,” such as improved pushability features). Although Eskuri’s guidewire ultimately aims to cross blockages/occlusions within body vessels, modifying Eskuri’s distal portion to become a fixed, sharp tine as proposed would seemingly create the same risks that Venbrux cites as something to avoid—undesirable engagement or Appeal 2018-004558 Application 13/719,687 11 snagging on the vessel walls as the guidewire with a sharp tip at its distal end moves to its target location. The Examiner responds by asserting that the test for obviousness is not whether certain features may be “bodily incorporated” into another reference, and that, rather, the features may fit together like pieces of a puzzle. Ans. 16–17. According to the Examiner, the rejection merely “changed” an element of Venbrux’s design “from having a function of being retractable to having a function of being fixed.” Id. at 17. And, the Examiner asserts, “Eskuri is all about engagement [with an occlusion] and expresses no concern about undesirable and/or premature engagement” with a vessel wall. Id. at 17–18. The Examiner’s response is unpersuasive. As explained above, when the teachings of Eskuri and Venbrux are considered as a whole, we do not agree with the Examiner’s position that it would have been obvious to modify Eskuri’s distal segment to have a sharp, tip/anchor (as shown in Venbrux) and to fix that tip/anchor at the device’s distalmost end. Eskuri’s device is designed to pass through body vessels, just as Venbrux’s—raising the same or similar problems if a sharp instrument were added in a fixed manner to the guidewire’s distalmost end. The Examiner does not demonstrate with persuasive evidence or technical reasoning that the disadvantage with such features, expressly evidenced in Venbrux, would have been outweighed in the eyes of the ordinarily skilled person by the purported advantage urged by the Examiner (i.e., using a sharp tip to increase penetration of an occlusion). Final Act. 4. That Eskuri allegedly “expresses no concern” about undesirable snagging or engagement with Appeal 2018-004558 Application 13/719,687 12 vessel walls speaks to the designs described in Eskuri, and does not demonstrate that such a concern would not exist if the device were changed in the manner proposed. Indeed, the absence of such “concern” in Eskuri may well be explained because Eskuri’s preferred designs include a semi- rounded end, not the sharp (but retractable) tips/anchors from Venbrux’s device. The Examiner selectively excises from Venbrux the sharp anchor feature, but disregards in hindsight Venbrux’s other material teaching about such a feature—that it should be retractable, not fixed in an extended position. In short, the pieces of the puzzle do not fit here, and making the proposed change to Eskuri is at odds with the teachings of Venbrux. On this record, we conclude that the person of ordinary skill in the art would not have changed Eskuri’s device as the Examiner proposes. For the above reasons, we determine that the preponderance of the evidence on this record does not support the Examiner’s conclusion that claims 1 and 12 would have been obvious over Eskuri and Venbrux. Accordingly, we reverse the rejection of claims 1 and 12, as well as the rejection of dependent claims 2–4, 8, 9, 13, 17, and 18. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) (“[D]ependent claims are nonobvious if the independent claims from which they depend are nonobvious.”). OBVIOUSNESS OVER ESKURI AND VENBRUX, IN FURTHER VIEW OF TERARSHI OR KHAIRKHAHAN The remaining rejections rely on the same combination of Eskuri and Venbrux and add additional references (Terashi or Khairkhahan) as teaching elements recited in some of the pending dependent claims. Final Act. 10– 13. The Examiner does not allege or demonstrate that the additional Appeal 2018-004558 Application 13/719,687 13 references make up for deficiencies in the combination of Eskuri and Venbrux in establishing that independent claims 1 and 12 would have been obvious. Id. Accordingly, we also reverse the rejections of the claims over Eskuri and Venbrux, in further view of Terashi or Khairkhahan. CONCLUSION For the reasons explained above, we find the preponderance of the evidence cited by the Examiner does not support the Examiner’s conclusion that claims 1–20 would have been obvious over the applied prior art. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 8, 9, 12, 13, 17, 18 103 Eskuri, Venbrux 1–4, 8, 9, 12, 13, 17, 18 5–7, 14–16 103 Eskuri, Venbrux, Terashi 5–7, 14–16 10, 11, 19, 20 103 Eskuri, Venbrux, Khairkhahan 10, 11, 19, 20 Overall Outcome 1–20 REVERSED Copy with citationCopy as parenthetical citation