Ex Parte Parker et alDownload PDFBoard of Patent Appeals and InterferencesMay 30, 201211076568 (B.P.A.I. May. 30, 2012) 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. 11/076,568 03/09/2005 Fred T. Parker 8627-641 (PA-5654-RFB) 6177 48003 7590 05/31/2012 BRINKS HOFER GILSON & LIONE/CHICAGO/COOK PO BOX 10395 CHICAGO, IL 60610 EXAMINER DOWE, KATHERINE MARIE ART UNIT PAPER NUMBER 3734 MAIL DATE DELIVERY MODE 05/31/2012 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte FRED T. PARKER and ANTHONY O. RAGHEB __________ Appeal 2011-001205 Application 11/076,568 Technology Center 3700 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. BONILLA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a stent delivery system. The Examiner has rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-001205 Application 11/076,568 2 STATEMENT OF THE CASE The claims are directed to a stent delivery system comprising at least one self-expandable stent and a holder. Claims 1-7, 9, and 21-31 are on appeal. Independent claim 1 is representative, and reads as follows (emphasis added): 1. A stent delivery system, comprising: at least one self-expandable stent expandable from a compressed state to an expanded state; and, a holder interlocking and interfering with the stent in the compressed state, the holder comprising a cylindrical body and a plurality of patterns or impressions integrally formed with an outer diameter of the cylindrical body, the plurality of patterns or impressions wrapping around at least a portion of a strut of the stent in the compressed state with a first edge and a second edge of two neighboring patterns or impressions in on opposite sides of the strut, wherein the first and the second edges extend toward the strut of the stent disposed between the two neighboring patterns or impressions; wherein the first and the second edges radially inwardly press over the strut of the stent and contact a portion of a radially outwardly exposed side surface of the strut of the stent and simultaneously restricts longitudinal movement of the stent relative to the holder; wherein the first and the second edges are made from a polymer tube; wherein the outer diameter of the holder at the first and the second edges is approximately the same as an outer diameter of the stent as a whole in the compressed state; and wherein the stent is expanded to the expanded state by stimulating the holder to release the stent from the holder by flexing the first and the second edges without substantially expanding the cylindrical body of the holder. Appeal 2011-001205 Application 11/076,568 3 The claims stand rejected as follows: • Claims 1, 3-5, and 23-25 under 35 U.S.C. §102(b) as anticipated by Igaki (U.S. Pat. Appl. Publ. No. 2003/0033001, published Feb. 13, 2003). • Claims 2, 21, 22, 27, and 28 under 35 U.S.C. §102(b) as anticipated by, or in the alternative, under 35 U.S.C. §103(a) as obvious over Igaki. • Claims 6 and 29-31 under 35 U.S.C. §103(a) as obvious over Igaki, in view of Armstrong (U.S. Pat. Appl. Publ. No. 2004/0015224, published Jan. 22, 2004). • Claim 7 under 35 U.S.C. § 103(a) as obvious over Igaki. • Claims 9 and 26 under 35 U.S.C. §103(a) as obvious over Igaki, in view of Andreas (U.S. Pat. Appl. Publ. No. 2004/0249435, published Dec. 9, 2004). I. Issues In relation to the anticipation rejection of claim 1 does the Examiner establish that Igaki discloses a stent holder comprising “the first and the second edges,” as well as a stent that can be released “without substantially expanding the cylindrical body of the holder,” as recited in claim 1? Findings of Fact 1. Figures 8 and 9 in the instant Specification show the following: Appeal 2011-001205 Application 11/076,568 4 Figure 8 depicts a stent delivery system, where arrows depict an exemplary drug coating process. Figure 9 depicts an enlarged view of a portion of the stent delivery system of Figure 8. 2. Figures 8 and 9 show a holder (502) with extensions (507) extending from the outer diameter thereof. (Spec. [0055].) The extensions (507) contact side surfaces of the stents, i.e., stent side surfaces (910) disposed at the holder‟s radical openings, and stent inner surfaces (920). (Id.) 3. Figures 6, 8 and 9 in Igaki show the following: Figure 6 is a cross-sectional view of a stent holding member (15) holding a stent (11) comprising fibers (17). Figure 8 depicts a cross-sectional view of a holder dilated to release the stent from the holder. Figure 9 depicts a Appeal 2011-001205 Application 11/076,568 5 perspective view showing the holder dilated to enlarge a groove (16) for holding the stent. 4. As described in Igaki, groove (16) “is formed in the outer periphral surface of the holder 15 so that about one half to a whole part of the cross- sectional profile of one fiber 17 as a supporting strut serving as a skeleton structure to maintain the shape of the stent 11 will be embedded in the groove, as shown in FIG. 6.” (Igaki [0062].) 5. Igaki also teaches that: Although the groove 16 may be of variegated shape, it is formed to a width narrower than the outer diameter of the fiber 17 embedded in the groove 16. By having the width of the groove 16 narrower than the outer diameter of the fiber 17 embedded therein, the stent 11 can be held under exploitation of the elastic force proper to the holder 15. (Id. at [0063].) 6. When discussing Figures 8 and 9, Igaki further states (emphasis added): [I]f the force acts from the inner periphery towards the outer periphery of the holder 15 as indicated by arrow X in FIG. 8, the holder 15 is enlarged in its outer diameter. The holder 15 is formed to a cylindrical shape, so that, if the holder 15 is enlarged in its outer diameter, an amount of expansion L2 on the outer periphery is larger than an amount of expansion L1 on the inner periphery, as shown in FIG. 9. Consequently, the groove 16 becomes deformed so that its open end is expanded to release the holding of the stent in the groove 16 to enable the stent 11 to be released from the holder 15. In case the stent 11 held by the holder 15 is of the self-expandable type, the stent is self-expanded and released from the holder 15. In case the stent 11 is the balloon expandable stent, the holder 15 is expanded Appeal 2011-001205 Application 11/076,568 6 and the stent is caused to be released from the holder 15 to expand the stent to its dilated state. (Id. at [0071].) 7. Igaki also teaches that “the holding power for the stent 11 may be further improved by exploiting the properties of the material of the holder 15,” and that “[i]n such case, the holder 15 is formed of a silicone resin exhibiting tackiness.” (Id. at [0073].) Principles of Law The Examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). If the Examiner meets that initial burden, the burden of coming forward with evidence or argument shifts to the applicant. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). After the applicant submits such evidence or argument, the PTO then determines patentability “on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.” Oetiker, 977 F.2d at 1445. Analysis Appellants first argue that Igaki fails to teach the recited edges, i.e., “a first edge and a second edge of two neighboring patterns or impressions in on opposite sides of the strut, wherein the first and the second edges extend toward the strut of the stent disposed between the two neighboring patterns or impressions” as recited in claim 1. (App. Br. 8-9.) Along the same lines, Appellants suggest that Igaki fails to disclose first and second edges that “radially inwardly press over the strut of the stent and contact a portion of a Appeal 2011-001205 Application 11/076,568 7 radially outwardly exposed side surface of the strut of the stent,” as also recited in claim 1. (Id. at 7, 11.) Appellants point to Figure 9 in the instant Specification as an example of the claimed invention. (App. Br. 7.) Appellants then refer to Figure 6 in Igaki, and state that “groove 16 does not have two neighboring edges that extend toward the fiber 17 of the stent” and that “Igaki engraves the groove 16 and the strut of the stent 11 is embedded in each assigned groove 16.” (App. Br. 8-9.) Finally, Appellants contend that Igaki‟s “groove 16 is U- shaped, V-shaped, or I-shaped as shown in Figures 7A to 7C . . . [and] [n]one of the disclosed shapes are suitable for, or intended to form edges as recited in the claimed invention.” (Reply Br. 2-3.) According to Appellants, the two neighboring edges in Igaki “are neither formed nor wrap around the strut of the stent 11.” (App. Br. 8-9.) We note that the “edges” shown in Figure 6 of Igaki look very similar to those shown in Figure 9 of the Specification. A difference is that in Figure 9 the two opposite edges circle around a larger part of the strut of the stent, while in Figure 6 of Igaki the edges only go half way around the strut. In other words, according to Appellants, Figure 6 in Igaki does not show two edges that “wrap around” (id.) more than half of the strut of the stent. As correctly noted by the Examiner, however, Igaki teaches in paragraph [0062] that stent fiber (17), i.e., a stent strut, may be embedded “about one half to a whole part” in a groove (16) of the holder (FF 4), even if “Figure 6 only shows about one half of the cross sectional profile of one strut (17) embedded in the groove” (Ans. 9). In other words, even if Figure 6 does not show it, Igaki describes elsewhere that a first edge and a second Appeal 2011-001205 Application 11/076,568 8 edge of two neighboring patterns in a holder may embed more than one half of the strut of the stent. Moreover, while Appellants correctly note that Igaki teaches that a U-, V-, or I-shaped groove may be engraved on the holder to receive the stent struts, the reference also teaches that the stent itself may serve as a die for forming the groove (Igaki [0064]). If a groove of the holder, i.e., a cylindrical body, embeds more than one half of the strut as taught in Igaki, the groove will comprise first and second edges that “extend toward the strut of the stent” and “radially inwardly press over the strut of the stent and contact a portion of a radially outwardly exposed side surface of the strut of the stent” as recited in claim 1. Appellants next argue that Igaki does not disclose a self-expandable stent that is “expanded … by stimulating the holder to release the stent from the holder by flexing the first and the second edges without substantially expanding the cylindrical body of the holder,” as recited in claim 1 (emphasis added). (App. Br. 9.) Appellants assert that Igaki teaches enlarging a holder‟s diameter with a balloon to release the stent, as shown in Figure 8. (Id.) In other words, according to Appellants, the stent in Igaki must be released by a balloon, which substantially expands the cylindrical body of the holder. We disagree. While Figure 8, and more specifically Figure 9, in Igaki show that a cylindrical body, i.e., groove (16), of a holder can expand to release a strut (17) of a stent, Igaki discloses more than this feature. Specifically, Igaki describes two different ways a stent may be released. In paragraphs [0070] and [0071], Igaki begins by discussing a balloon expandable stent, and refers to Figures 8 and 9 in this regard, exactly as Appeal 2011-001205 Application 11/076,568 9 referenced by Appellants. Thereafter, however, in paragraph [0071], Igaki states: In case the stent 11 held by the holder 15 is of the self-expandable type, the stent is self-expanded and released from the holder 15. In case the stent 11 is the balloon expandable stent, the holder 15 is expanded and the stent is caused to be released from the holder 15 to expand the stent to its dilated state. (FF 6.) The two quoted sentences above distinguish between two different types of stents, i.e., a self-expandable stent and a balloon expandable stent. The self-expandable stent is released from the holder by expanding the stent, while the balloon expandable stent is released from the holder by expanding the holder. We also note that the instant Specification does not define the phrase “without substantially expanding” or the term “substantially” as recited in the last clause of claim 1. Thus, we consider the ordinary meaning of the claim phrase to one of ordinary skill in the art. Prima Tek II, L.L.C. v. Polypap S.A.R.L., 318 F.3d 1143, 1148 (Fed. Cir. 2003). Here, the word “substantially” denotes language of magnitude because it describes how much the cylindrical body can expand. In that context, case law indicates that “substantially” can mean “significantly” or “considerably.” Deering Precision Instruments, LLC v. Vector Distrib. Sys., Inc., 347 F.3d 1314, 1323 (Fed. Cir. 2003) (citing Webster's New 20th Century Dictionary 1817 (1983)). The broadest reasonable reading of the phrase in light of the Specification indicates that the cylindrical body can expand, albeit not significantly. Thus, as noted by the Examiner, the phrase does not mean that the cylindrical body cannot expand at all, but rather than it may expand insubstantially, i.e., at least minimally. (Ans. 11; see also Epcon Gas Sys., Appeal 2011-001205 Application 11/076,568 10 Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1031 (Fed.Cir.2002) (stating that “the phrase „substantially below‟ signifies language of magnitude, i.e., not insubstantial.”).) Here, nothing in Igaki suggests that a groove (16) expands “substantially” when it releases a self expandable stent. Rather, Igaki indicates that a self-expandable stent itself expands to stimulate its own release, not that that a groove in the holder expands, much less that a groove expand substantially. Thus, the Examiner establishes a prima facie case that Igaki discloses a stent that is released from a holder “without substantially expanding the cylindrical body of the holder” as recited in claim 1. In response, Appellants do not point to teachings in Igaki or elsewhere, or provide evidence, to the contrary. (See, e.g., Reply Br. 4-5.) Thus, we are not persuaded by Appellants‟ arguments in this regard. Conclusion of Law We conclude that the Examiner establishes that Igaki discloses a stent holder comprising “the first and the second edges,” as well as a stent that can be released “without substantially expanding the cylindrical body of the holder,” as recited in claim 1. 1 1 None of claims 1, 3-5, and 23-25 stand rejected under 35 U.S.C. §103(a). (Ans. 3.) Accordingly, we are not persuaded by Appellants‟ contentions directed to an asserted rejection of these claims as obvious (see App. Br. 4, 9-13). Appeal 2011-001205 Application 11/076,568 11 II. Issues In relation to the anticipation and obviousness rejections of claim 2 does the Examiner establish that Igaki discloses and/or suggests a stent holder comprising “the first and the second edges,” as well as a stent that can be released “without substantially expanding the cylindrical body of the holder”? Analysis Appellants argue that because Igaki discloses that groove (16) is “formed to a width narrower than the outer diameter of the fiber 17,” i.e., a strut of the stent (FF 5), the reference teaches away from the claimed invention by suggesting that relevant edges are not used to hold the fiber 17. (App. Br. 11.) As discussed above, Igaki teaches in paragraph [0062] that stent fiber (17), i.e., a stent strut, may be embedded “about one half to a whole part” in a groove (16) of the holder (FF 4). If a groove of the holder, i.e., a cylindrical body, wraps around more than one half of the strut as taught in Igaki, the groove will comprise first and second edges that “extend toward the strut of the stent” and “radially inwardly press over the strut of the stent and contact a portion of a radially outwardly exposed side surface of the strut of the stent” as recited in claim 1, from which claim 2 depends. In other words, the edges of the holder groove hold the strut of the stent. Moreover, we agree with the Examiner that such description in Igaki (FF 4) is consistent, or at least not inconsistent, with teaching elsewhere in Appeal 2011-001205 Application 11/076,568 12 Igaki that groove (16) be “formed to a width narrower than the outer diameter of the fiber 17,” i.e., a strut of the stent (FF 5.) As stated by the Examiner (Ans. 10), once the fiber is embedded in the groove by more than one half, the groove will no longer have a width more narrower than the strut, even assuming the groove is originally “formed to” be more narrow. Thus, contrary to arguments by Appellants, Igaki does not teach away from the “edges as specified in Group 1 claims” (App. Br. 11). This is also the case regardless of whether Igaki also discloses that “the holding power for the stent 11 may be further improved by exploiting the properties of the material of the holder 15,” such as, for example, where “the holder 15 is formed of a silicone resin exhibiting tackiness.” (FF 7; see also Appellants‟ arguments at App. Br. 12-13) As noted by the Examiner, “„tackiness‟ of the holder is simply an added benefit” described in Igaki, and does not constitute a teaching away. (Ans. 10-11.) We are likewise not persuaded by Appellants‟ assertion that “in Igaki, it is entirely unclear how a self-expandable stent could be released without the balloon.” (App. Br. 12 (emphasis in original); see also id. at 10.) As discussed above, Igaki indicates that a self-expanding stent is released by expanding the stent itself. Thus, unlike a balloon expandable stent and what is shown in Figure 9 of the reference, Igaki teaches that a self-expandable stent works as recited in claim 1, i.e., “wherein the stent is expanded … without substantially expanding the cylindrical body of the holder.” Conclusion of Law We conclude that the Examiner establishes that Igaki discloses and suggests a stent holder comprising “the first and the second edges,” as well Appeal 2011-001205 Application 11/076,568 13 as a stent that can be released “without substantially expanding the cylindrical body of the holder.” III. Issue Does the preponderance of the evidence establish that claim 6 is obvious over Igaki in view of Armstrong? Analysis Appellants argue that claims 6 and 29-31 (Group 2) “are patentable over the cited art for many of the same reasons given above in the discussion of Group 1,” i.e., claims 1-5, 21-25, 27, and 28. (App. Br. 14.) For the reasons we state above, the “same reasons given” by Appellants in relation to Group 1 claims do not persuade us that the Examiner has erred in finding Group 2 claims obvious. Conclusion of Law We conclude that the preponderance of the evidence establishes that claim 6 is obvious over Igaki in view of Armstrong. IV. Issue Does the preponderance of the evidence establish that claim 7 is obvious over Igaki? Appeal 2011-001205 Application 11/076,568 14 Analysis Appellants argue that claim 7 (Group 3) “is patentable over the cited art for many of the same reasons given above in the discussion of Group 1.” (Id.) For the reasons we state above, the “same reasons given” by Appellants in relation to Group 1 claims do not persuade us that the Examiner has erred in finding claim 7 obvious. Conclusion of Law We conclude that the preponderance of the evidence establishes that claim 7 is obvious over Igaki. V. Issue Does the preponderance of the evidence establish that claim 9 is obvious over Igaki in view of Andreas? Analysis Appellants argue that claims 9 and 26 (Group 4) “are patentable over the cited art for many of the same reasons given above in the discussion of Group 1.” (Id.) For the reasons we stated above, the “same reasons given” by Appellants in relation to Group 1 claims do not persuade us that the Examiner has erred in finding Group 4 claims obvious. Conclusion of Law We conclude that the preponderance of the evidence establishes that claim 9 is obvious over Igaki in view of Andreas. Appeal 2011-001205 Application 11/076,568 15 SUMMARY We affirm the rejection of claim 1 under 35 U.S.C. §102(b) as anticipated by Igaki. Claims 3-5 and 23-25 are not separately argued and fall together with claim 1. We affirm the rejection of claim 2 as anticipated by, or obvious under 35 U.S.C. §103(a) over, Igaki. Claims 21, 22, 27, and 28 are not separately argued and fall together with claim 2. We also affirm the rejections of claim 6 as obvious over Igaki in view of Armstrong, claim 7 as obvious over Igaki, and claim 9 as obvious over Igaki in view of Andreas. Claims 29-31 and 26 are not separately argued and fall together with claims 6 and 9 respectively. 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 alw Copy with citationCopy as parenthetical citation