Ex Parte Matov et alDownload PDFPatent Trial and Appeal BoardMar 30, 201712795911 (P.T.A.B. Mar. 30, 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. 12/795,911 06/08/2010 Nadia P. Matov 32164-710.201 1844 21971 7590 04/03/2017 WILSON, SONSINI, GOODRICH & ROSATI 650 PAGE MILL ROAD PALO ALTO, CA 94304-1050 EXAMINER RODJOM, KATHERINE MARIE ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 04/03/2017 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): patentdocket @ wsgr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NADIA P. MATOV, JAYSON DE LOS SANTOS, GUILLERMO PIVA, TANHUM FELD, and EITAN KONSTANTINO Appeal 2014-008797 Application 12/795,9111 Technology Center 3700 Before MICHAEL C. ASTORINO, ROBERT J. SILVERMAN, and ALYSSA A. FINAMORE, Administrative Patent Judges. ASTORINO, Administrative Patent Judge. DECISION ON APPEAL The Appellants appeal under 35U.S.C. § 134 from the Examiner’s decision rejecting claims 1—8. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 According to the Appellants, the real party in interest is “TriReme Medical, Inc.” Appeal Br. 3. Appeal 2014-008797 Application 12/795,911 STATEMENT OF THE CASE Claimed Subject Matter Claim 1, the sole independent claim, is representative of the subject matter on appeal and is reproduced below. 1. A balloon catheter having improved crossing characteristics, said catheter comprising a catheter body having a distal end, a proximal end, and an inflatable balloon near the distal end, wherein a distal tip of the catheter body is asymmetrically beveled relative to an axis of the catheter body and wherein the catheter body is torsionally reinforced over at least a distal portion thereof to improve rotation of the beveled tip when the catheter body is in the vasculature. Grounds of Rejection2 I. Claims 1^4 are rejected under 35 U.S.C. § 103(a) as unpatentable over Heller (US 5,628,755, iss. May 13, 1997) and Lee (US 6,206,852 Bl, iss. Mar. 27, 2001).3 II. Claims 1—6 are rejected under 35 U.S.C. § 103(a) as unpatentable over Hoo (EP 1,836,998 Al, pub. Sept. 26, 2007) and Lee. III. Claim 1 is rejected under 35 U.S.C. § 102(b) as anticipated by Lee. IV. Claims 7 and 8 are rejected under 35 U.S.C. § 103(a) as unpatentable over Lee, Williams (US 2005/0015108 Al, pub. Jan. 20, 2005), and Vardi (US 6,692,483 B2, iss. Feb. 17, 2004). 2 To facilitate our analysis, we set forth the grounds of rejection in a different order than the order presented in the Examiner’s Answer and Appellants’ Briefs. 3 The Examiner has withdrawn the rejection of claim 5 under 35 U.S.C. § 103(a) as unpatentable over Heller and Lee. Ans. 2. 2 Appeal 2014-008797 Application 12/795,911 ANALYSIS Rejection I - claims 1—4 as unpatentable over Heller and Lee Independent claim 1 Independent claim 1 is directed to a balloon catheter comprising a catheter body and where the “catheter body is torsionally reinforced over at least a distal portion thereof to improve rotation of the beveled tip when the catheter body is in the vasculature.”4 Appeal Br., Claims App. The term “torsionally reinforced” further defines the “catheter body” functionally, which makes the foregoing recitation of claim 1 a functional limitation. A patent applicant is free to recite features of an apparatus either structurally or functionally. See In re Swinehart, 439 F.2d 210, 212 (CCPA 1971) (“[TJhere is nothing intrinsically wrong with [defining something by what it does rather than what it is] in drafting patent claims.”). “Yet, choosing to define an element functionally, i.e., by what it does, carries with it a risk.” In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). As stated in Swinehart, 439 F.2d at 213: [W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. The Examiner finds that the Specification offers numerous examples of how a catheter body is capable of being “torsionally reinforced.” See 4 The claimed “catheter body” includes “a distal end, a proximal end,” “an inflatable balloon near the distal end,” and “a distal tip.” See Appeal Br., Claims App. 3 Appeal 2014-008797 Application 12/795,911 Ans. 3 (citing Spec. 14, 16, 17, 22, 37, 39, 41). For example, the Examiner points to the Specification at paragraph 14, which instructs one of ordinary skill in the art that a body of a balloon catheter is torsionally reinforced by using a “cylindrical polymer sleeve.” See Ans. 3. The Specification describes “cylindrical polymer sleeve” as a type of “torque bridge.” Spec. 114. Notably, a “torque bridge . . . allow[s] torque delivery through the balloon region of the catheter body.” Id. 114; see also id. 137. Moreover, the Specification describes: [t]he torque bridge can be in a form of cylindrical polymer sleeve disposed over or attached to at least a portion of the balloon and covering the balloon taper and all or part of the balloon working length. Id. 114 (formatting and emphasis added). Accordingly, a cylindrical polymer sleeve includes a sleeve that is cylindrical, a polymer, disposed over at least a portion of a balloon (of a balloon catheter), and covers a balloon taper and part of the balloon working length. See also id. H 37—38, Figs. 2, 3 a—b. The Examiner finds Heller discloses a catheter body that is torsionally reinforced. See Final Act. 3^4 (citing Heller Figs. 1, 2); Ans. 4—5. Indeed, Heller’s sleeve 11 acts as a “cylindrical polymer sleeve” form of “torque bridge.” Sleeve 11 is cylindrical, a polymer, disposed over at least a portion of balloon 3, and covers balloon 3’s taper and part of balloon 3’s working length. See Ans. 4—5; Heller, col. 3,11. 15—16, Figs. 1, 2, 4. Accordingly, the Examiner has a reason to believe that the functional limitation of claim 1, i.e., “catheter body is torsionally reinforced over at least a distal portion thereof to improve rotation of the beveled tip when the catheter body is in 4 Appeal 2014-008797 Application 12/795,911 the vasculature” is an inherent characteristic of Heller’s catheter body. See also Swinehart, 439 F.2d at 213. We have considered the Appellants’ arguments in the Appeal Brief and the Reply Brief for this rejection, and determine that they are not persuasive. See Appeal Br. 7—8; Reply Br. 4—5. The Appellants fail to prove Heller’s catheter body is not torsionally reinforced due to sleeve 11. See also Swinehart, 439 F.2d at 213. For example, the Appellants point out that Heller’s sleeve 11 is able to slide and move relative to balloon 3 and is not fixedly attached to shaft 1. See Appeal Br. 7—8. However, this point does not appear to consider the following facts: proximal end 4 and distal end 5 of Heller’s balloon 3 is welded on shaft 1 (see Ans. 4—5 (citing Heller, col. 5,11. 1—7)); and sleeve 11 has a close interconnection with armature 7, and when operating balloon 3 in a reduced size (see Heller, Fig. 2, 4), “the distal portion 9 of armature 7 partly engages and friction fits onto the enlargement provided for by the proximal welding 4 of the balloon 3 on the shaft 1” (Heller, col. 5,11. 23—26, 54—57, Fig. 4). As such, Heller discloses sleeve 11 in fixed attachment — albeit an indirect fixed attachment — to balloon 3 and shaft 1. Accordingly, Heller’s sleeve 11 also acts as a “cylindrical polymer sleeve” type of “torque bridge” because it is cylindrical, a polymer, attached to at least a portion of balloon 3, and covers balloon 3’s taper and part of balloon 3’s working length. Thus, the rejection of claim 1 as unpatentable over Heller and Lee is sustained. Dependent claim 2 Dependent claim 2 recites “wherein at least a portion of the balloon is covered with an expandable sleeve.” Appeal Br., Claims App. Notably, 5 Appeal 2014-008797 Application 12/795,911 although claim 2 requires the sleeve to be expandable, the claim does not articulate in what regard the sleeve is expandable. See id. For purposes of comparison only, dependent claim 5, which depends from claim 2, articulates — with particularity — how the sleeve is expandable, i.e., “wherein the sleeve is elastic to expand and contract over the balloon as the balloon is inflated and deflated.” See id. The Appellants argue that one of ordinary skill in the art would not consider sleeve 11 expandable because sleeve 11 is intended to prevent expansion of balloon 3 and is lined by armature 7, a coiled metal wire, preferably made of a high density metal. Appeal Br. 8 (citing Heller, col. 5, 11. 10-16). Although the Appellants’ argument explains persuasively why sleeve 11 cannot expand due to the expansion of balloon 3 — e.g., as required by claim 5 — it does not explain why sleeve 11, which Heller describes as “preferably made of a substantially flexible polymer,” cannot otherwise expandable. See Ans. 5 (quoting Heller, col. 5,11. 15—16). Thus, the rejection of claim 2 as unpatentable over Heller and Lee is sustained. Dependent claim 3 Dependent claim 3 recites “wherein the expandable sleeve covers at least a distal region of the balloon to enhance column strength of a distal region of the catheter body and to present a smooth forward-facing surface as the catheter is advanced through the vasculature.” Appeal Br., Claims App. Although the Appellants’ argument references a “proximal portion,” the Appellants appear to contend that sleeve 11 does not cover a distal region balloon 3. See Appeal Br. 8. This contention is persuasive. Thus, the rejection of claim 3 as unpatentable over Heller and Lee is not sustained. 6 Appeal 2014-008797 Application 12/795,911 Dependent claim 4 With regard to the rejection of dependent claim 4 which depends from claim 2, the Appellants rely on the argument advanced for the rejection of claim 2, i.e., that Heller’s sleeve 11 is not expandable. Appeal Br. 8—9. For the reasons discussed above, the Appellants’ argument is not persuasive. Thus, the rejection of claim 4 as unpatentable over Heller and Lee is sustained. Rejection II - claims 1—6 as unpatentable over Hoo and Lee Independent claim 1 We have considered the Appellants’ arguments in the Appeal Brief and the Reply Brief for this ground of rejection, and determine that they are not persuasive. The Appellants primarily argue that the catheter body of Hoo’s balloon catheter is not torsionally reinforced, as required by claim 1. Appeal Br. 10. The Examiner finds that the catheter body of Hoo’s balloon catheter is torsionally reinforced by sleeve (film) 30. See Final Act. 4—5; Ans. 6—7. We agree. As discussed above, a catheter body is understood to be “torsionally reinforced,” if it includes a cylindrical polymer sleeve, i.e., includes a sleeve that is cylindrical, a polymer, disposed over or attached to at least a portion of a balloon (of a balloon catheter), and covers a balloon taper and part of the balloon working length. And, Hoo’s sleeve 30 is cylindrical, a polymer, i.e., nylon, disposed over or attached to at least a portion of balloon 90 (of a balloon catheter), and covers balloon 90’s taper and part of balloon 90’s working length. See Final Act. 4—5 (citing Hoo, Fig. 4); Ans. 6 (citing Hoo 1 15). 7 Appeal 2014-008797 Application 12/795,911 Additionally, the Appellants point out that “film 30 is . . . described as rupturing when the balloon and stent are expanded.” Appeal Br. 10. The Appellants contend that “it is unclear whether the film of Hoo would improve the torsional stiffness of the catheter body” because the region of sleeve 30 that ruptures “affect[s] the structural integrity of the base material, decreasing the column strength and torsional rigidity of the film.” Reply Br. 5-6. The Appellants’ contention is not persuasive because it fails to prove the catheter body of Hoo’s balloon catheter is not torsionally reinforced. See also Swinehart, 439 F.2d at 213. For example, although Hoo’s sleeve 30 includes at least one region 40 that ruptures (see Hoo 113), the Appellants’ Specification similarly includes a catheter body that is torsionally reinforced by use of a sleeve that ruptures, i.e., splits (see, e.g., Spec. 14 (original dependent claim 6)). As such, merely because a sleeve can rupture does not suggest that the sleeve would fail to torsionally reinforce a catheter body of a balloon catheter. Moreover, we note Hoo discloses that the expansion of stent 20 applies a force to sleeve 30, which eventually causes sleeve 30 to rupture. See Hoo 117. The term “eventually” implies a moment of time where a force is applied to sleeve 30 that expands sleeve 30 but fails to rupture sleeve 30; and at this moment of time, sleeve 30 provides a catheter body with torsional reinforcement as required by independent claim 1. Thus, the rejection of claim 1 as unpatentable over Hoo and Lee is sustained. 8 Appeal 2014-008797 Application 12/795,911 Dependent claim 2 As discussed above, dependent claim 2 recites “wherein at least a portion of the balloon is covered with an expandable sleeve.” Appeal Br., Claims App. The Examiner explains that Hoo’s sleeve 30 is made of an expandable material, i.e., nylon. See Final Act. 7; Ans. 6—7; see also Reply Br. 5 (The Appellants acknowledge that “the film of Hoo may be formed of the same base material as the expandable sleeve of the claimed invention.”). The Appellants argue that one skilled in the art would not consider Hoo’s rupturable film to be expandable. Appeal Br. 10. This argument is not persuasive. As discussed above, according to the Appellants’ Specification, a sleeve that splits, i.e., ruptures, can also be expandable. See Spec. 14 (original dependent claim 6). More particularly, dependent claim 6, by virtue of its dependency on claims 1 and 2, requires that an expandable sleeve is able to split, i.e., rupture, as the balloon is inflated. See Ans. 7. Similarly, Hoo’s sleeve 30 is able to rupture as balloon 90 expands. Thus, the rejection of claim 2 as unpatentable over Hoo and Lee is sustained. Dependent claims 3 and 4 To the extent that the Appellants provide a substantive argument that additional limitations of claims 3 and 4 are not met by Hoo’s disclosure (see Appeal Br. 10), we disagree. Rather, we agree with the Examiner that Hoo’s film 30 “covers both the proximal and distal ends of the balloon (Fig 4).” Ans. 7; see Final Act. 5. Thus, the rejection of claims 3 and 4 as unpatentable over Hoo and Lee is sustained. 9 Appeal 2014-008797 Application 12/795,911 Dependent claim 5 Dependent claim 5 recites, “wherein the sleeve is elastic to expand and contract over the balloon as the balloon is inflated and deflated.” Appeal Br., Claims App. The Appellants argue that “the film of [Hoo] is never shown or suggested to be elastic to expand and contract over the balloon as the balloon is inflated and deflated. As noted above, it is specifically taught to rupture.” Appeal Br. 11. The Appellants’ argument is not persuasive for similar reasons as discussed above with regard to independent claim 1 and dependent claim 2. Here, the Appellants do not persuasively explain why Hoo’s sleeve 30 cannot expand and contract without rupturing. Thus, the rejection of claim 5 as unpatentable over Hoo and Lee is sustained. Dependent claim 6 With regard to the rejection of claim 6, the Appellants rely on the unpersuasive arguments advanced for the rejection of claim 1. See Appeal Br. 11. Thus, the rejection of claim 6 as unpatentable over Hoo and Lee is sustained. Rejections III and IV - claim 1 as anticipated by Lee and claims 7 and 8 as unpatentable over Lee, Williams, and Vardi Independent claim 1 The Examiner finds Lee discloses a “catheter body is torsionally reinforced over at least a distal portion thereof to improve rotation of the beveled tip when the catheter body is in the vasculature,” as recited by independent claim 1 (Appeal Br., Claims App.). See Final Act. 2. The Examiner supports this finding by pointing to Lee’s Figure 13, which depicts 10 Appeal 2014-008797 Application 12/795,911 “a balloon catheter having a tip (60) fixedly attached to the catheter body (inner member 16) and balloon (15).” Ans. 3 (citing Lee, col. 4,11. 35—37). Additionally, the Examiner advances the following position: since the claims do not recite any structural characteristics of the torsional reinforcement, the fixed attachment of the distal tip to the catheter meets the claim limitation in that the attached tip strengthens the distal end of the catheter body and the tip must rotate with the catheter body due to the fixed attachment. Ans. 4; see also id. at 3. The Appellants argue that Lee’s catheter body is not torsionally reinforced as required by claim 1. See Appeal Br. 6—7; Reply Br. 2—3. The Appellants assert that the overlap of tip 60 with catheter body 16 is de minimis and “would hardly ‘improve rotation of the beveled tip when the catheter body is in the vasculature’ as required by claim 1.” Appeal Br. 7. The Appellants’ argument is persuasive. As discussed above, the Examiner finds that the Specification offers numerous examples of how a catheter body is capable of being “torsionally reinforced.” See Ans. 3 (citing Spec. Tflf 14, 16, 17, 22, 37, 39, 41). As we understand the Examiner’s findings for this rejection (Rejection III), the Examiner’s application of Lee’s catheter tip to independent claim 1 does not overlap with the examples in the Specification. This is not to suggest that using the examples in the Specification of what can be considered torsional reinforcement for a catheter body is the determinative factor in our analysis. Rather, the examples provide guidance on how one of ordinary skill in the art, upon reading the Specification, would understand the functional limitation of claim 1, i.e., “the catheter body is torsionally reinforced over at least a distal portion thereof to improve rotation of the beveled tip when the 11 Appeal 2014-008797 Application 12/795,911 catheter body is in the vasculature.” In this case, even if we were to agree that the fixed attachment associated with Lee’s catheter tip provides stiffness (see Ans. 3—4), the Examiner fails to adequately explain, based upon evidence or technical reasoning, how balloon 15, inner member 16, and tip 60 would improve the rotation of the beveled tip when the catheter body is in a patient’s vasculature. Thus, the rejection of independent claim 1 as anticipated by Lee is not sustained. Dependent claims 7 and 8 Additionally, the rejection of dependent claims 7 and 8 suffers from same the flaw as the rejection claim 1. This flaw is not remedied by the modification of Lee’s device in view of combined teachings of Williams and Vardi. See final Act. 5—6. As such, the rejection of claims 7 and 8 as unpatentable over Lee, Williams, and Vardi is also not sustained. DECISION We ALLIRM the Examiner’s decision rejecting: claims 1, 2, and 4 under 35 U.S.C. § 103(a) as unpatentable over Heller and Lee (“Rejection I”); and claims 1—6 under 35 U.S.C. § 103(a) as unpatentable over Hoo and Lee (“Rejection II”). We REVERSE the Examiner’s decision rejecting: claim 3 under 35 U.S.C. § 103(a) as unpatentable over Heller and Lee (“Rejection I”); claim 1 under 35 U.S.C. § 102(b) as anticipated by Lee (“Rejection III”); and claims 7 and 8 under 35 U.S.C. § 103(a) as unpatentable over Lee, Williams, and Vardi (“Rejection IV”). 12 Appeal 2014-008797 Application 12/795,911 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED-IN-PART 13 Copy with citationCopy as parenthetical citation