BOSTON SCIENTIFIC SCIMED, INC.Download PDFPatent Trials and Appeals BoardOct 29, 202013709867 - (D) (P.T.A.B. Oct. 29, 2020) 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. 13/709,867 12/10/2012 RAJ SUBRAMANIAM 8150BSC0183 1000 121974 7590 10/29/2020 Kacvinsky Daisak Bluni PLLC Cathy R Ryan 2601 Weston Parkway, Suite 103 Suite 103 Cary, NC 27513 EXAMINER HULBERT, AMANDA K ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 10/29/2020 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): bbonneville@kdbfirm.com docketing@kdbfirm.com ehysesani@kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RAJ SUBRAMANIAM and ZAYA TUN ____________ Appeal 2020-001655 Application 13/709,867 Technology Center 3700 ____________ Before JENNIFER D. BAHR, MICHELLE R. OSINSKI, and SEAN P. O’HANLON, Administrative Patent Judges. OSINSKI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1–11, 15, 16, and 18–24.2 We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Boston Scientific Scimed, Inc. Appeal Br. 2. 2 Claims 12–14 and 17 are cancelled. See Amendment (Sept. 27, 2017). Appeal 2020-001655 Application 13/709,867 2 THE CLAIMED SUBJECT MATTER Claims 1 and 16 are independent. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. An intravascular catheter for nerve modulation through the wall of a blood vessel, comprising: a shaft having a proximal end and a distal end and a central axis; a balloon disposed on the shaft and having a proximal end, a distal end, an interior surface, and exterior surface, a lumen defined by the interior surf ace, the balloon as molded comprising a plurality of elongate ridges; a first electrode disposed on the balloon; a first elongate elastomeric member disposed between the first electrode and the balloon, wherein the first elastomeric member is a generally longitudinal elastomeric member that is disposed between the elongate ridges of the balloon and is under tension when the balloon is in an inflated state; and a first radial elastomeric band that circumferentially surrounds the balloon around a longitudinal axis of the balloon. EVIDENCE The Examiner relied on the following evidence in rejecting the claims on appeal: Name Reference Date Whayne US 6,142,993 Nov. 7, 2000 Swanson US 6,640,120 B1 Oct. 28, 2003 Bencini US 8,128,617 B2 Mar. 6, 2012 Wang US 8,702,619 B2 Apr. 22, 2014 Demarais US 8,774,913 B2 July 8, 2014 THE REJECTIONS I. Claims 23 and 24 stand rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. Final Act. 5. Appeal 2020-001655 Application 13/709,867 3 II. Claims 23 and 24 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Id. at 4. III. Claims 1–10, 12, 13, 15, 16, and 21–24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Swanson, Bencini, and Wang. Id. at 5–9. IV. Claims 11, 18, and 19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Swanson, Bencini, Wang, and Whayne. Id. at 9–10. V. Claim 20 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Swanson, Bencini, Wang, and Demarais. Id. at 10. OPINION Rejection I – Indefiniteness Each of dependent claims 23 and 24 recites “wherein the first radial elastomeric band exists independently of the balloon.” Appeal Br. 18–19 (Claims App.). The Examiner determines that the claims are indefinite because “the phrase ‘exists independently’ does not clearly define a relationship between the balloon and the band.” Final Act. 5. Appellant argues that the identified claim language does not render the claims indefinite because “th[e] recitation clearly defines a relationship between the balloon and the band in that it establishes that the band is independent of the balloon.” Appeal Br. 10; see also Reply Br. 11 (asserting the identified claim language “merely requires that the . . . band [exists] independently of the balloon and does not purport to define the particularities of the relationship between them”). The broadest reasonable Appeal 2020-001655 Application 13/709,867 4 interpretation of the identified phrase “exists independently” merely requires that the first radial elastomeric band is a distinct element of the claimed intravascular catheter relative to the balloon, and does not specify whether or not there is contact or attachment between the first radial elastomeric band and balloon. This interpretation is consistent with Appellant’s Specification, which describes that “[o]ne or more circumferential elastomeric members 26 may be disposed around the outside of the balloon.” Spec. 7:25–26. In other words, each circumferential elastomeric member 26 is a distinct element that surrounds balloon 22 (i.e., circumferential elastomeric members 26 are not an integral part of balloon 22). The Examiner takes the position that the Specification “merely suggests that the elastomeric band is located on top of the balloon, not whether they are attached or not attached to each other.” Ans. 5. However, the Examiner has not explained, nor it is apparent, why the definiteness of the phrase “exists independently” relates to whether or not the balloon and radial elastomeric band are attached. That is, although we agree with the Examiner that a broadest reasonable interpretation of “exists independently” provides no information regarding whether the balloon and radial elastomeric band are attached or not, thereby resulting in a broad construction that encompasses both, such a concern addresses breadth, not indefiniteness. See In re Miller, 441 F.2d 689, 693 (CCPA 1971); In re Gardner, 427 F.2d 786, 788 (CCPA 1970) (“Breadth is not indefiniteness.”). The Examiner does not explain adequately why the breadth of the claims should be equated to indefiniteness in this case. In other words, the identified claim language is sufficiently clear so as not to render the claims indefinite. Appeal 2020-001655 Application 13/709,867 5 For these reasons, we do not sustain the rejection of claims 23 and 24 under 35 U.S.C. § 112, second paragraph, as being indefinite. Rejection II – Written Description The Examiner finds that Appellant’s Specification fails to provide adequate written description support for the limitation in dependent claims 23 and 24 reciting that “the first radial elastomeric band exists independently of the balloon.” Final Act. 4. In particular, the Examiner finds that “[t]he specification does not specifically mention the ‘independence’ of the band from the balloon and thus it does not appear the phrase has support in the originally filed specification.” Id. Appellant argues that “the specification provides sufficient support and guidance for one skilled in the art to make and/or use the subject matter claimed.” Appeal Br. 9 (citing Spec. 6:15–22, 7:16–9:8). The fundamental factual inquiry for ascertaining sufficient written description is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention as presently claimed. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562–64 (Fed. Cir. 1991). “This inquiry . . . is a question of fact,” and “the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Ariad, 598 F.3d at 1351. “[T]he specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id. Appeal 2020-001655 Application 13/709,867 6 Here, although the Specification does not recite the claim term “exists independently” in describing the radial elastomeric band, this is not dispositive because “the [written] description requirement does not demand any particular form of disclosure, . . . or that the specification recite the claimed invention in haec verba.” Ariad, 598 F.3d at 1352. As discussed above in connection with Rejection I, the Specification describes the radial elastomeric band as a distinct element that is not a part of the balloon. See, e.g., Spec. 7:25–26. In other words, the description of the balloon and radial elastomeric band in the Specification is sufficient to reasonably convey to a person of ordinary skill in the art that Appellant was in possession of an intravascular catheter having a radial elastomeric band that exists independently of the balloon (i.e., the radial elastomeric band is a distinct element, and not part of the balloon). Accordingly, we do not sustain the rejection of claims 23 and 24 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Rejection III – Obviousness based on Swanson, Bencini, and Wang Claims 1–8, 10, 12, 13, 15, 16, and 21–24 In contesting the rejection of claims 1–8, 10, 12, 13, 15, 16, and 21–24, Appellant presents arguments for independent claims 1 and 16 together, and does not separately argue dependent claims 2–8, 10, 12, 13, 15, and 21–24. See Appeal Br. 9–13. We select independent claim 1 as Appeal 2020-001655 Application 13/709,867 7 representative, and claims 2–8, 10, 12, 13, 15, 16, and 21–24 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv) (2018). In rejecting claim 1, the Examiner finds that Swanson discloses an intravascular catheter having most of the limitations of claim 1, including, in relevant part, a balloon, a first electrode disposed on the balloon, and a first elongate elastomeric member that is generally longitudinal. Final Act. 5–6. The Examiner finds that “Swanson does not expressly disclose a balloon that is molded comprising a plurality of elongated ridges, with the elastomeric members and bands separate from the balloon and disposed between the elongated ridges of the balloon.” Id. at 6. However, the Examiner finds that Bencini teaches “that it was known in the art of balloon catheters to mold a catheter balloon to include ridges corresponding to desired splines or ridges (e.g. Col. 9, lines 7–37) and for the spline structure to be separate from the balloon structure (e.g. Col. 12, lines 1–17).” Id. The Examiner determines that it would have been obvious “to include the balloon ridges of Bencini in the device of Swanson in order to provide the system with the predictable results of a reliable balloon capable of providing stimulation.” Id. The Examiner finds that “Swanson additionally does not disclose a circumferential radial band.” Final Act. 6. However, the Examiner finds that Wang teaches that “it was known in the art of balloon catheters to include a circumferential radial band (e.g. Figure 3A).” Id. The Examiner determines that it would have been obvious “to include the circumferential member of Wang in the device of Swanson since such a modification would provide the system with the predictable results of a more reliable means of holding the balloon in the desired location.” Id. at 7. Appeal 2020-001655 Application 13/709,867 8 Appellant argues that helical coil 37 depicted in Figure 3A of Wang does not constitute a “radial elastomeric band that circumferentially surrounds the balloon around a longitudinal axis of the balloon,” as recited in claim 1. Appeal Br. 10. Appellant asserts that “a helix surrounds a longitudinal axis in three dimensions, and at no single point or plane along the axis does the helix have a circumference that surrounds the axis.” Id. Appellant asserts that, “[i]n contrast, the elastomeric band, as recited and as plainly understood from the description in the specification, at the location at which it is situated with respect to the balloon, defines a two-dimensional plane in which the band circumferentially surrounds the balloon.” Id. (citing Drawings, Fig. 5). According to Appellant, the Examiner “gives no weight to the word ‘circumferentially,’ because there is no difference between ‘surrounds’ and ‘circumferentially surrounds’ with the Examiner’s interpretation.” Id. at 11. We are not persuaded by Appellant’s argument. The Examiner responds that “[t]he claim as currently filed does not require that the ‘circumferentially surround[s]’ need be in two dimensions instead of the three dimensions . . . taught by Wang.” Ans. 5 (quoting Adv. Act. 2). The Examiner explains that “weight [was given] to the term ‘circumferentially’ by requiring that the elastomeric member surround the balloon completely around the longitudinal axis.” Id. at 6. The Examiner takes the position that “Figure 3A of Wang clearly shows an elastomeric member that ‘circumferentially surrounds’ the longitudinal axis in three dimensions.” Id. In this regard, Appellant does not persuasively refute the Examiner’s interpretation that Wang’s helical coil 37 circumferentially surrounds the balloon around its longitudinal axis. Moreover, although claims are interpreted in light of the Specification, Appellant does not point Appeal 2020-001655 Application 13/709,867 9 to any disclosure in the Specification that would necessitate an interpretation of “circumferentially surrounds” as precluding a three-dimensional shape, such as Wang’s helical coil 37. Appellant argues that “[m]odifying the balloon 22 of Swanson to incorporate the helical coil 37 of Wang . . . would render the device of Swanson unsuited for its intended purpose because the balloon 22 of Swanson is ellipsoidal and has no cylindrical portion to accommodate the helical coil of Wang.” Appeal Br. 12 (citing Swanson Fig. 12). Appellant asserts that Wang’s helical coil 37 “would have most of its body hanging freely from the ellipsoidal balloon 22 of Swanson rendering the balloon 22 unable to achieve the function discussed in Swanson of bulging beyond the basket assembly 18 to bring the balloon 22 in direct contact with tissue.” Id. (citing Swanson 7:52–61, Fig. 5); see also Reply Br. 16 (asserting that “a helical coil as described in Wang is incompatible with a[n] ellipsoidal balloon as described in Swanson”). This argument is not persuasive. The Examiner responds that, in each of Swanson and Wang, the “combination of elastomeric bands and balloons are used for the same purpose of applying electrical stimulation at the same place the balloon is located . . . .” Ans. 6. In this regard, Appellant does not persuasively refute the Examiner’s position. Even if some adaptation of Wang’s coil would be required to work with Swanson’s ellipsoidal balloon, Appellant does not proffer factual evidence or persuasive technical reasoning to explain how combining the balloon of Swanson with the helical coil of Wang in an operable manner would be beyond the level of ordinary skill in the art. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”); In Appeal 2020-001655 Application 13/709,867 10 re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). Thus, we are unpersuaded by Appellant’s contention that combining Wang’s helical coil with Swanson’s balloon, as proposed by the Examiner, would render Swanson’s device inoperable or unsuitable for its intended purpose. See Appeal Br. 12. For the above reasons, Appellant does not apprise us of error in the Examiner’s conclusion of obviousness with respect to claim 1. Accordingly, we sustain the rejection of claim 1, and claims 2–8, 10, 12, 13, 15, 16, and 21–24 falling therewith, under 35 U.S.C. § 103(a) as unpatentable over Swanson, Bencini, and Wang. Claim 9 In rejecting claim 9, which depends from independent claim 1, the Examiner finds that Wang teaches “a second radial band surrounding the balloon (e.g. as shown in Figure 2E).” Final Act. 7; see also Ans. 7 (explaining that “Wang discloses that singular or double helix embodiments can be combined with a balloon catheter system (e.g. Wang, Col. 25, lines 60–67)”). In contesting the rejection of claim 9, Appellant initially relies on the same arguments and reasoning that we found unpersuasive in connection with the rejection of independent claim 1. Appeal Br. 13. Appellant also argues that “the double helix of Wang is a pair of helical coils 27 for an ablation catheter, and Wang does not teach or suggest combining this pair of coils with a balloon.” Appeal Br. 13; see also Reply Br. 17 (asserting that the cited portion of Wang does not support the Examiner’s finding). We are not persuaded by this argument. Appeal 2020-001655 Application 13/709,867 11 Wang teaches an ablation catheter that includes helical coil 37 wrapped around balloon 33. Wang 10:49–53; see also id. at 8:20–22 (teaching that “the catheter tip may comprise a balloon around which is wrapped a helical coil”). Wang also teaches that, “[i]n certain embodiments, the catheter tip of the ablation catheter comprises a single helix; in others, it is composed of double helix.” Id. at 25:53–55. In other words, Wang teaches certain embodiments of the ablation catheter in which the balloon may be wrapped by a helical coil, where the helical coil may be a single or double helix. In light of this disclosure, Appellant’s argument does not identify error in the Examiner’s finding, which is supported by a preponderance of the evidence. For the above reasons, Appellant does not apprise us of error in the Examiner’s conclusion of obviousness with respect to claim 9. Accordingly, we sustain the rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable over Swanson, Bencini, and Wang. Rejections IV and V – Obviousness based on Swanson, Bencini, Wang, and one of Whayne and Demarais With respect to Rejections IV and V, Appellant does not set forth any additional substantive arguments separate from the arguments discussed supra; instead adding only that Whayne and Demarais do not cure the asserted deficiencies in Rejection III. See Appeal Br. 14 (asserting that “none of Swanson, Bencini, Wang, Whayne, Demarais, individually, nor any combination thereof, teaches or suggests, ‘. . . a [first] radial elastomeric band that circumferentially surrounds the balloon around a longitudinal axis of the balloon . . .,’ as recited by independent claims 1 and 16”). Thus, for the same reasons that Appellant’s arguments do not apprise us of error in Appeal 2020-001655 Application 13/709,867 12 Rejection III, Appellant also does not apprise us of error in Rejections IV and V. Accordingly, we sustain the rejections under 35 U.S.C. § 103(a) of claims 11, 18, and 19 as unpatentable over Swanson, Bencini, Wang, and Whayne, and claim 20 as unpatentable over Swanson, Bencini, Wang, and Demarais. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 23, 24 112, second paragraph Indefiniteness 23, 24 23, 24 112, first paragraph Written Description 23, 24 1–10, 12, 13, 15, 16, 21–24 103(a) Swanson, Bencini, Wang 1–10, 12, 13, 15, 16, 21–24 11, 18, 19 103(a) Swanson, Bencini, Wang, Whayne 11, 18, 19 20 103(a) Swanson, Bencini, Wang, Demarais 20 Overall Outcome 1–11, 15, 16, 18–24 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)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation