Ex Parte BrownDownload PDFBoard of Patent Appeals and InterferencesJun 22, 200910960265 (B.P.A.I. Jun. 22, 2009) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte BRIAN J. BROWN __________ Appeal 2009-001829 Application 10/960,265 Technology Center 3700 __________ Decided:1 June 22, 2009 __________ Before DONALD E. ADAMS, ERIC GRIMES, and MELANIE L. McCOLLUM, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims 1-26, all of the pending claims, which are directed to a stent. The Examiner has rejected 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date shown on this page of the decision. The time period does not run from the Mail Date (paper delivery) or Notification Date (electronic delivery). Appeal 2009-001829 Application 10/960,265 the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. STATEMENT OF THE CASE The Specification discloses a helical stent that comprises “a helically wound ribbon of material” (Spec. 1: 31-32). Figure 4 of the Specification is shown below: Figure 4 shows “a stent comprising a helically wound ribbon in an expanded state” (id. at 2: 30-31). The Specification discloses that the ribbon “may include a first rail or edge member 20 and a second rail or edge member 30. … At least one and desirably a plurality of connector struts 40 may connect the first rail 20 to the second rail 30” (id. at 4: 5-11). The Specification also discloses that “the ribbon 12 may have a width dimension ‘w’ or spacing between the first rail 20 and the second rail 30” (id. at 6: 31-32) and that the ribbon may also have a “longitudinal width wl [which] is the distance between a first rail 20 and a second rail 30, as measured in a direction parallel to the stent longitudinal axis 60” (id. at 5: 31 - 6: 1). The Specification also discloses that “[d]esirably, the width w of a ribbon 12 in 2 Appeal 2009-001829 Application 10/960,265 an expanded state is greater than the width w of the ribbon 12 in an unexpanded state. Upon expansion of a ribbon 12, the shape of a connector strut 40 may change and the length of a connector strut 40 along its connector strut axis 50 may increase” (id. at 5: 12-15). Claim 1 is representative and reads as follows: Claim 1: A stent comprising a helically wound ribbon of material, the stent having a longitudinal axis extending therethrough, the ribbon having a width dimension, wherein the stent is constructed and arranged such that the width dimension of the ribbon in an expanded state of the stent exceeds the width dimension of the ribbon in an unexpanded state of the stent. ANTICIPATION Issue The Examiner has rejected claims 1-26 under 35 U.S.C. § 102(b) as being anticipated by Barclay.2 The claims have been argued in four groups: claims 2-9, 11, and 12 stand or fall with claim 1; claim 10 stands or falls alone; claims 14-18 stand or fall with claim 13; and claims 20-26 stand or fall with claim 19. 37 C.F.R. § 41.37(c)(1)(vii). The Examiner finds that the “stent blank of [Barclay’s] figure 1B … will have a reduced width in an unexpanded configuration and an increased width in the expanded configuration … [b]y pulling on opposite corners of the stent blank” to form a stent shape that may be wound, delivered and released, such that the stent will expand and increase in width upon release (Office Action mailed Feb. 1, 2007, at 7-8). 2 Barclay et al., US 2002/0082682 A1, Jun. 27, 2002. 3 Appeal 2009-001829 Application 10/960,265 Appellant contends that the Examiner erred in finding that Barclay discloses a ribbon stent “constructed and arranged such that the width dimension of the ribbon in an expanded state of the stent exceeds the width dimension of the ribbon in an unexpanded state of the stent” (Appeal Br. 7- 9). The main issue presented is: Does the evidence of record support the Examiner’s finding that Barclay discloses a ribbon stent “constructed and arranged such that the width dimension of the ribbon in an expanded state of the stent exceeds the width dimension of the ribbon in an unexpanded state of the stent?” Findings of Fact 1. Barclay discloses “devices and methods for the delivery of a biologically active agent by a coiled prosthesis, typically a covered coiled stent” (Barclay ¶ 0002). 2. Barclay discloses that the prosthesis comprises a coiled body having … radially- extending openings, the coiled body being movable from a radially-contracted state to a radially-expanded state. A material extends along a coiled path along the entire coiled body. A dispensable, biologically active agent is associated with at least one of the coiled body and material. (Id. at ¶ 0055.) 3. Figures 1B and 1E of Barclay are shown below: 4 Appeal 2009-001829 Application 10/960,265 Figure 1B is said to show a design of a stent blank (id. at ¶ 0064) and Figure 1E is said to show a coiled stent made from the stent blank of Figure 1B (id. at ¶ 0065). 4. Barclay discloses that the stent body includes “side edge or rail elements 110 connected by connector or rung elements 112 to define openings 113” (id. at ¶ 0089). 5. Barclay discloses that [c]oil-type stents can be wound about the catheter shaft in torqued compression for deployment. The coil-type stent can be maintained in this torqued compression condition by securing the ends of the coil-type stent in position on a catheter shaft. The ends are released by, for example, pulling on wires once at the target site. (Id. at ¶ 0009.) 5 Appeal 2009-001829 Application 10/960,265 6. Barclay discloses that stents are typically made from either a malleable material that is expanded by a balloon catheter at the target site or a self-expanding structure made from, e.g., Nitinol or stainless steel (id. at ¶ 0005). 7. The Specification’s Figure 8 is shown below: The figure shows “another embodiment of a ribbon 12 which may be wound to form a stent” (Spec. 7: 32 to 8: 1). 8. The Specification’s Figure 9 is shown below: The figure shows “the ribbon of Figure 8 in an expanded configuration. . . . The connector struts 40 desirably extend from a rail 20, 30 at a greater angle in the expanded state than in the unexpanded state, up to a maxiumum of 90°” (id. at 8: 13-17). 6 Appeal 2009-001829 Application 10/960,265 9. The Specification discloses that “[i]n some embodiments, a first rail 20 and a second rail 30 may be slidably engaged with one another when the ribbon 12 is wound helically” (Spec. 9: 7-9). 10. The Specification does not define the term “slidably engaged.” 11. The Specification discloses that “Figures 12-14 show various embodiments of mechanisms for engagement between the first rail 20 and the second rail 30” (id. at 9: 9-11). Figures 12-14 show that rails 20 and 30 are physically connected. 12. Figure 12 of the Specification is shown below: Figure 12 shows the first rail and the second rail interacting via a tongue and groove mechanism. Principles of Law In response to the PTO’s asserted prima facie case the applicant may argue that the inference of lack of novelty was not properly drawn, for example if the PTO did not correctly apply or understand the subject matter of the reference, or if the PTO drew unwarranted conclusions therefrom. However, when the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). 7 Appeal 2009-001829 Application 10/960,265 [T]he PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Analysis Claim 1 is directed to a stent comprising a helically wound ribbon of material, and constructed and arranged so that the stent ribbon is wider in the expanded state than it is in the unexpanded state. Barclay discloses (Figure 1B) a helical stent ribbon having rails and struts. Barclay does not disclose the material used to make the stent framework but discloses that stents are typically made of either a malleable material or a resilient material such as Nitinol or stainless steel. Barclay also discloses that the stent can be moved from a radially contracted state to a radially expanded state, and that coil-type stents (i.e., helical stents) can be wound about a catheter shaft in torqued compression for deployment. The Examiner reasons that the Barclay stent blank of figure 1B is capable of being manipulated so that the device will have a reduced width in an unexpanded configuration and an increased width in the expanded configuration. The Examiner contends that this may be achieved in a similar manner as that shown in figures 8 and 9 of the Applicant’s disclosure. By pulling on opposite corners of the stent blank, for example the upper-left and lower-right corners, the stent will deform into a shape similar to that of figure 8. The stent may then be wound into a helix in this state and delivered. Upon release, the stent will both expand and 8 Appeal 2009-001829 Application 10/960,265 increase in width direction because the blank will return to the shape of figure 1B. (Office action mailed Feb. 1, 2007, pages 7-8.) We agree with the Examiner’s reasoning. The stent shown in Barclay’s Fig. 1E is capable of assuming a state in which the corners shown at the left- and right-hand sides in that figure are moved away from each other; that is, a “stretched,” or radially contracted state. In a stretched, radially contracted state, the openings of Barclay’s stent would not have the basically rectangular shape shown in Figure 1B but would be stretched into a longer, narrower quadrilateral shape. Therefore, we agree with the Examiner that, just as with the stents shown in the Specification’s Figures 8 and 9, when Barclay’s stent is in the state that Barclay describes as “radially contracted” it is reasonable to expect that it would have a ribbon width that is less than the width of the ribbon in the stent’s released, expanded state. For the same reason, we agree with the Examiner that when Barclay’s stent changes from a radially contracted state to the radially expanded state shown in Figure 1E, it is reasonable to expect that the width of each turn increase, as recited in claim 13,3 because the width of each turn depends on the width of the ribbon. Appellant contends that “Barclay does not discuss a width dimension of the ‘stent blank’ changing between [the] unexpanded and expanded 3 Claim 13 reads: “A stent comprising a substantially helically wound ribbon, the ribbon comprising a plurality of turns about a central longitudinal axis of the stent, each turn of the ribbon having a width, wherein the width of each turn increases upon expansion of the stent.” 9 Appeal 2009-001829 Application 10/960,265 states” and that any finding of anticipation that relies on an inherent disclosure of this claim limitation is improper (Appeal Br. 7). This argument is not persuasive. Although Barclay does not expressly disclose changing its stent blank between expanded and unexpanded states, Barclay’s product reasonably appears capable of assuming those states. Based on the structure of Barclay’s product, it is also reasonable to conclude that it would have the property that the “width dimension of the ribbon in an expanded state of the stent [would] exceed[ ] the width dimension of the ribbon in an unexpanded state of the stent.” “[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not. Spada, 911 F.2d at 708. Appellant has provided no evidence showing that Barclay’s ribbon does not possess the disputed property. Thus, the rejection of claim 1 as being anticipated by Barclay is affirmed. With regard to claim 10,4 the Examiner reasons that “Figure 1E shows that upon helical winding, rails on opposite sides of the stent do engage. As shown in figures 7A-7C, the rails will slide against each other during expansion” (Answer 10). Appellant contends that Barclay does not disclose rail members that are “slidably engaged” (Appeal Br. 10). Appellant contends that “[a]lthough the outermost rails of the Barclay stent blank are shown adjacent to one another in Figure 1E, … [a] person of ordinary skill in the art would 4 Claim 10 reads: “[The stent of claim 1, wherein the ribbon comprises a first rail and a second rail, the first rail connected to the second rail by a plurality of connector struts], wherein the first rail is slidably engaged with the second rail.” 10 Appeal 2009-001829 Application 10/960,265 recognize that the limitation ‘slidably engaged’ requires more than merely being located next to one another” (Reply Br. 7). Appellant contends that in “the mechanical context of this art, the term ‘engaged’ generally means ‘interlocked’” (id.). Appellant’s arguments are persuasive. In accord with In re Morris, claim terms are given their broadest reasonable interpretation in view of the Specification. The Specification does not expressly define the term “slidably engaged” but Appellant has provided a dictionary definition to support his position that “engaged” in the mechanical context means “interlocked.” The Examiner has not provided evidence that those skilled in the art would have understood “engaged” to mean something else. In addition, all of the embodiments of slidable engagement in the Specification show physical connection between the rails. Thus, given the definition of “engage” in this context and given that all of the embodiments of slidable engagement show physical connection, we conclude that the broadest reasonable interpretation for the term “slidably engaged” requires a physical connection capable of sliding. The Examiner has not adequately shown that such a structure is disclosed by Barclay. Thus, the rejection of claim 10 as being anticipated by Barclay is reversed. With regard to claim 19,5 Appellant argues that “Barclay does not discloses or suggest a stent wherein upon expansion of the stent, the width 5 Claim 19 reads: “An unexpanded coil stent comprising: a strip helically wound about a longitudinal axis of the stent, the strip having a width dimension; the strip having a predetermined number of turns about the longitudinal axis, wherein upon expansion of the stent, the number of turns 11 Appeal 2009-001829 Application 10/960,265 dimension of the ‘stent blank’ increases. . . . Further, the Examiner has not asserted that the limitations of claim 19 are inherently disclosed by any stent structure that was originally taught by Barclay.” (Appeal Br. 11.) Appellant’s arguments are persuasive. Claim 19 is directed to “[a]n unexpanded coil stent” configured so that the number of turns decreases and the width of the strip increases upon expansion. That is, claim 19 specifies that the claimed stent is in an unexpanded state. While we agree with the Examiner that Barclay’s stents are capable of being put in an unexpanded (radially contracted) state, the Examiner has pointed to no disclosure in Barclay of a stent that is actually in such a state. The Examiner therefore has not shown that Barclay discloses the stent defined by claim 19, or claims 20-26, which depend on claim 19. CONCLUSIONS OF LAW The evidence of record supports the Examiner’s finding that Barclay discloses a ribbon stent “constructed and arranged such that the width dimension of the ribbon in an expanded state of the stent exceeds the width dimension of the ribbon in an unexpanded state of the stent.” SUMMARY We affirm the rejection of claims 1-9 and 11-18 under 35 U.S.C. § 102(b) as being anticipated by Barclay. However, we reverse the rejection of claim 10 and 19-26. of the strip about the longitudinal axis decreases and the width dimension of the strip increases.” 12 Appeal 2009-001829 Application 10/960,265 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART cdc VIDAS, ARRETT & STEINKRAUS, P.A. SUITE 400, 6640 SHADY OAK ROAD EDEN PRAIRIE MN 55344 13 Copy with citationCopy as parenthetical citation