Trials@uspto.gov
`571.272.7822
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` Paper No. 21
`October 31, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`v.
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01281
`Patent 7,828,767 B2
`____________
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`STACY B. MARGOLIES, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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`571.272.7822
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` Paper No. 21
`October 31, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`v.
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01281
`Patent 7,828,767 B2
`____________
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`STACY B. MARGOLIES, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
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`IPR2017-01281
`Patent 7,828,767 B2
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`I.
`INTRODUCTION
`Edwards Lifesciences Corporation (“Petitioner”) challenges the
`patentability of claims 1–12, 14, 16, and 17 of U.S. Patent No. 7,828,767 B2
`(Ex. 1001, “the ’767 patent”), owned by Boston Scientific Scimed, Inc.
`(“Patent Owner”). We have jurisdiction under 35 U.S.C. § 6(c) to hear this
`inter partes review instituted pursuant to 35 U.S.C. § 314. In this Final
`Written Decision, issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R.
`§ 42.73, we find on the record before us that Petitioner has shown by a
`preponderance of the evidence that claims 5, 6, 8–12, 14, 16 and 17 of the
`’767 patent are unpatentable for the reasons discussed below. See 35 U.S.C.
`§ 316(e).
`
`A.
`PROCEDURAL HISTORY
`Petitioner filed a Petition requesting institution of inter partes review
`of claims 1–12, 14, 16, and 17 of the ’767 patent. Paper 2 (“Pet.”). Patent
`Owner filed a Preliminary Response. Paper 8 (“Prelim. Resp.”). We
`initially instituted review only of challenged claims 5, 6, 8–12, 14, 16, and
`17, because we determined the Petition showed a reasonable likelihood that
`Petitioner would prevail as to those challenged claims on the following
`grounds (the “First Set of Grounds”):
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`Reference(s)
`
`Basis Claim(s) Challenged
`§ 102
`5
`Dlugos1
`§ 103
`5
`Dlugos and Eskaros2
`§ 103
`8
`Dlugos, Eskaros, and Hijlkema3
`§ 103
`6, 14, and 16
`Dlugos, Eskaros, and Forman4
`§ 103
`9, 10, and 12
`Dlugos, Eskaros, and Traxler5
`Dlugos, Eskaros, Traxler, and Forman § 103
`11
`Dlugos, Eskaros, Forman, and Becker6 § 103
`17
`Paper 9 (“Inst. Dec.”); see also 35 U.S.C. § 314. Our Case Management and
`Scheduling Order set a deadline for Patent Owner to file a response to the
`instituted grounds of the Petition and cautioned Patent Owner that “any
`arguments for patentability not raised in the response will be deemed
`waived.” Paper 10, 6. Patent Owner did not file a response. We
`subsequently confirmed during a conference call with the parties on
`February 21, 2018, that, by not filing a response, Patent Owner waived any
`arguments for patentability with regard to the grounds instituted.
`Paper 13, 3.
`Prior to the scheduled oral argument in this case, the Supreme Court
`held in SAS Inst., Inc. v. Iancu that a decision to institute under 35 U.S.C.
`§ 314 may not institute on fewer than all claims challenged in the
`
`
`1 WO 2007/020087 A1, pub. Feb. 22, 2007 (Ex. 1008, “Dlugos”).
`2 U.S. Patent App. Pub. No. 2008/0097300 A1, pub. Apr. 24, 2008
`(Ex. 1011, “Eskaros”).
`3 U.S. Patent No. 5,853,389, iss. Dec. 29, 1998 (Ex. 1009, “Hijlkema”).
`4 U.S. Patent No. 5,501,759, iss. Mar. 26, 1996 (Ex. 1012, “Forman”).
`5 U.S. Patent App. Pub. No. 2001/0047149 A1, pub. Nov. 29, 2001
`(Ex. 1013, “Traxler”).
`6 U.S. Patent No. 4,251,305, iss. Feb. 17, 1981 (Ex. 1014, “Becker”).
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`petition. 138 S. Ct. 1348, 1359–60 (2018). As explained above, prior to
`SAS Inst., we had not instituted review on all of the challenged claims in this
`case. See Inst. Dec. 31. In accordance with SAS Inst., we modified the
`Institution Decision to include review of all challenged claims on all grounds
`asserted in the Petition. Paper 15, 3–4. In particular, we further instituted
`review on the following additional grounds asserted in the Petition (the
`“Second Set of Grounds”):
`Basis Claim(s) Challenged
`Reference(s)
`§ 103
`1, 2, 4, 5, and 8
`Dlugos and Hijlkema
`§ 103
`3
`Dlugos, Hijlkema, and Konstantino7
`§ 103
`6, 14, and 16
`Dlugos, Hijlkema, and Forman
`§ 103
`5
`Dlugos
`§ 103
`7
`Dlugos, Eskaros, and Konstantino
`§ 103
`1
`Dlugos and Bampos8
`Id. at 4. We also permitted the parties to seek additional briefing with regard
`to the Second Set of Grounds. Id. Based upon the parties’ requests, we
`authorized Patent Owner to rely on the arguments it raised in its Preliminary
`Response as to the Second Set of Grounds in place of filing a Patent Owner
`response and we authorized Petitioner to file a reply only to issues raised in
`either the Institution Decision or Patent Owner’s Preliminary Response and
`only with respect to the Second Set of Grounds. Paper 16, 3. Petitioner
`filed a Reply in accordance with our prior authorization. Paper 17
`(“Reply”). Oral argument was held before the Board on August 7, 2018.
`Paper 20 (“Tr.”).
`
`7 U.S. Patent App. Pub. No. 2005/0177130 A1, pub. Aug. 11, 2005
`(Ex. 1010, “Konstantino”).
`8 U.S. Patent No. 6,013,055, iss. Jan. 11, 2000 (Ex. 1015, “Bampos”).
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`B.
`RELATED MATTERS
`According to the parties, the ’767 patent is asserted in the United
`States District Court for the Central District of California, in a case
`captioned Boston Scientific Corp. and Boston Scientific Scimed, Inc. v.
`Edwards Lifesciences Corp., Civil Action No. 8:16-cv-0730 (C.D. Cal.).
`Pet. 72; Paper 3, 2.
`C.
`REAL PARTIES IN INTEREST
`Petitioner identifies only itself as a real party in interest. Pet. 72.
`Patent Owner identifies itself and Boston Scientific Corp. as real parties in
`interest. Paper 3, 2.
`
`II.
`BACKGROUND
`The ’767 patent, titled “Balloon Design and Weld Design to
`Increase Ease of Re-Wrapping and Decrease Withdrawal Force,” issued
`November 9, 2010, from U.S. Application No. 12/129,380, filed
`May 29, 2008. Ex. 1001. As background information, below we provide a
`summary of the ’767 patent and two illustrative claims from the ’767 patent
`and we identify the proffered expert testimony.
`A.
`SUMMARY OF THE ’767 PATENT
`The ’767 patent generally relates “to a balloon catheter where a
`balloon cylinder is folded to form pleats and then is welded directly to the
`catheter,” and a method of making the same. Id. at 2:18–24.
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`The ’767 patent illustrates a portion of a prior art balloon catheter in
`Figure 1, reproduced below.
`
`
`Figure 1 illustrates prior art balloon catheter 22, including a preformed
`balloon with center region 26, cone 4, and weld 20 at which the waist of the
`balloon is welded to shaft 18. Ex. 1001, 1:46–51. Similar structures are
`present at both the proximal end (closest to the operator of the catheter) and
`the distal end (furthest from the operator) of the balloon catheter. See
`Ex. 1001, 1:46 (referring to Figure 21 as an “end view”); Prelim. Resp. 2.
`According to the ’767 patent, Figure 1 shows center region 26 folded to a
`smaller outer diameter after being welded to shaft 18, but cone 4 is not
`folded, creating a bulky transition region. Ex. 1001, 1:54–65.
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`Figures 9 and 11 of the ’767 patent are reproduced below.
`
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`Partial side views of an embodiment of the claimed balloon catheter 122
`after balloon 100 has been welded to outer shaft 118b illustrate the balloon
`in a deflated state in Figure 9 and in an inflated state in Figure 11. Ex. 1001,
`2:54–56, 2:60–61, 5:25–32. Balloon 100 has smooth middle region 126 and
`pleated cone regions 124. Id. at 5:32–35. “[T]he folds 112 of the pleated
`cone regions 124 facilitate re-wrapping along the original folds 112.” Id. at
`5:35–37. According to Petitioner, the “extension of the folds through the
`cone regions and into the welds is the sole invention of the ’767 patent.”
`Pet. 3. Patent Owner states that the ’767 patent is “directed to a unique
`balloon design and a method of manufacturing a balloon,” but offers no
`substantive description of the invention of the ’767 patent. Prelim.
`Resp. 2–4.
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`ILLUSTRATIVE CLAIMS
`B.
`Challenged claims 1 and 5 are independent. Challenged claims 2–4
`depend from claim 1, and challenged claims 6–12, 14, 16, and 17 depend
`from claim 5. Claims 1 and 5 are illustrative of the claimed subject matter
`and are reproduced below:
`1. A balloon catheter, the balloon catheter comprising:
`at least one shaft; and
`a balloon, the balloon comprising a first weld region, a first cone
`region, a middle region, a second cone region and a second
`weld region, the first weld region engaging the balloon to the
`at least one shaft, the first cone region adjacent to the first
`weld region, the middle region between the first cone region
`and the second cone region, the second cone region adjacent
`to the second weld region, the second weld region engaging
`the balloon to the at least one shaft, the balloon having an
`uninflated state and an inflated state, the balloon having at
`least one fold extending from the first weld region to the
`second weld region in the uninflated state and the first and
`second cone regions of the balloon having at least one fold
`in the fully inflated state.
`Ex. 1001, 6:40–55.
`5. A method for making a balloon catheter comprising:
`providing a balloon cylinder, the balloon cylinder having a first
`end and a second end, the first end and the second end
`separated by a longitudinal length;
`providing a catheter comprising at least one shaft;
`incorporating at least one fold, the at least one fold extending
`from the first end to the second end of the balloon cylinder;
`and
`welding the balloon cylinder with the at least one fold to the at
`least one shaft of the catheter.
`Ex. 1001, 7:1–10.
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`PROFFERED EXPERT DECLARATION
`C.
`Petitioner supports its challenge with a Declaration of Thomas Trotta,
`dated April 17, 2017. Ex. 1005. Mr. Trotta is an “independent consultant”
`and states that he has more than thirty years of experience involving the
`processes used to manufacture percutaneous transluminal coronary
`angioplasty (PTCA) catheters and stent delivery systems. Id. ¶¶ 1, 6; see
`also Ex. 1006 (curriculum vitae of Mr. Trotta). Mr. Trotta further states that
`he is “a named inventor of thirty-three patents, of which twenty-eight
`address discoveries and improvements pertaining to balloon catheters.”
`Id. ¶ 7); see also Ex. 1007 (list of patents on which Mr. Trotta is a named
`inventor). Patent Owner did not proffer an expert declaration in this case.
`III. ANALYSIS
`In our analysis of Petitioner’s unpatentability contentions with respect
`to the challenged claims of the ’767 patent over the asserted prior art, we
`next address the applicable principles of law; the level of ordinary skill in
`the art; the construction of the claim terms “fold” and “balloon cylinder”;
`and the scope and content of the asserted prior art of Dlugos, Eskaros,
`Hijlkema, Forman, Traxler, Becker, Konstantino, and Bampos. We then
`discuss the First Set of Grounds for which there is no Patent Owner response
`and then we turn to the Second Set of Grounds for which Patent Owner was
`authorized to rely on its Preliminary Response in opposition to Petitioner’s
`contentions.
`
`A.
`PRINCIPLES OF LAW
`To prevail in its challenge to the patentability of claims 1–12, 14, 16,
`and 17 of the ’767 patent, Petitioner must prove unpatentability by a
`preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
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`“In an [inter partes review], the petitioner has the burden from the onset to
`show with particularity why the patent it challenges is unpatentable.”
`Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016)
`(citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to
`identify “with particularity . . . the evidence that supports the grounds for the
`challenge to each claim”)). This burden never shifts to Patent Owner. See
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015) (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d
`1316, 1326–27 (Fed. Cir. 2008)) (discussing the burden of proof in inter
`partes review).
`In an inter partes review, “[a] claim in an unexpired patent . . . shall
`be given its broadest reasonable construction in light of the specification of
`the patent in which it appears.” 37 C.F.R. § 42.100(b); Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (upholding the use of the
`broadest reasonable interpretation standard). In determining the broadest
`reasonable construction, we presume that claim terms carry their ordinary
`and customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249,
`1257 (Fed. Cir. 2007). A patentee may define a claim term in a manner that
`differs from its ordinary meaning; however, any special definitions must be
`set forth in the specification with reasonable clarity, deliberateness, and
`precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`A claim is anticipated if a single prior art reference either expressly or
`inherently discloses every limitation of the claim. Orion IP, LLC v. Hyundai
`Motor Am., 605 F.3d 967, 975 (Fed. Cir. 2010). “A single prior art reference
`may anticipate without disclosing a feature of the claimed invention if such
`feature is necessarily present, or inherent, in that reference.” Allergan, Inc.
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`v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014) (citing Schering Corp. v.
`Geneva Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)).
`A patent claim is unpatentable as obvious under 35 U.S.C. § 103(a) if
`“the differences between” the claimed subject matter “and the prior art are
`such that the subject matter as a whole would have been obvious at the time
`the invention was made to a person having ordinary skill in the art to which
`said subject matter pertains.” 35 U.S.C. § 103(a). An invention “composed
`of several elements is not proved obvious merely by demonstrating that each
`of its elements was, independently, known in the prior art.” KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398, 418 (2007). Rather, “it can be important to
`identify a reason that would have prompted a person of ordinary skill in the
`relevant field to combine the elements in the way the claimed new invention
`does.” Id.
`An obviousness determination “cannot be sustained by mere
`conclusory statements; instead, there must be some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness.” Id. (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006));
`see In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir.
`2016). The question of obviousness is resolved on the basis of underlying
`factual determinations, including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of skill in the art; and (4) objective evidence of nonobviousness.
`Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).
`In determining whether an invention would have been obvious at the
`time it was made, 35 U.S.C. § 103 requires us to resolve the level of
`ordinary skill in the pertinent art at the time of the invention. Graham, 383
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`U.S. at 17. “The importance of resolving the level of ordinary skill in the art
`lies in the necessity of maintaining objectivity in the obviousness inquiry.”
`Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991). The
`person of ordinary skill in the art is a hypothetical person who is presumed
`to have known the relevant art at the time of the invention. In re GPAC,
`Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Factors that may be considered in
`determining the level of ordinary skill in the art include, but are not limited
`to, the types of problems encountered in the art, the sophistication of the
`technology, and educational level of active workers in the field. Id. In a
`given case, one or more factors may predominate. Id. Generally, it is easier
`to establish obviousness under a higher level of ordinary skill in the art.
`Innovention Toys, LLC v. MGA Entm’t, Inc., 637 F.3d 1314, 1323 (Fed. Cir.
`2011) (“A less sophisticated level of skill generally favors a determination of
`nonobviousness . . . while a higher level of skill favors the reverse.”).
`B.
`LEVEL OF ORDINARY SKILL IN THE ART
`Petitioner contends that a person of ordinary skill in the art at the time
`of the claimed invention would have had either of the following
`qualifications: (1) “an undergraduate degree in mechanical manufacturing
`or material science engineering, as well as at least five years of experience in
`the industry working with catheters and balloons and the manufacturing of
`those devices; or without an undergraduate degree,” or (2) “ten years of
`working experience designing, manufacturing and/or overseeing the
`processes for designing and/or manufacturing the tools and/or the devices.”
`Pet. 14. Mr. Trotta supports Petitioner’s contention with regard to the level
`of ordinary skill in the art. Ex. 1005 ¶ 57. Patent Owner does not contest
`Petitioner’s asserted level of ordinary skill in the art. See Prelim.
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`Resp. 6 n.3. Based on the evidence provided, including the prior art of
`record, we agree with Petitioner’s proposed level of ordinary skill and also
`find that the prior art of record further reflects the level of ordinary skill in
`the art. See also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
`2001) (noting that the prior art of record may reflect the level of ordinary
`skill in the art).
`
`C.
`
`CLAIM CONSTRUCTION
`
`“fold”
`1.
`Claims 1 and 5 each recite “at least one fold.” Ex. 1001, 6:52, 7:6.
`Petitioner contends that “fold” includes “folds, pleats, wings, lobes, wraps,
`wrappings, or protrusions.” Pet. 13. In support, Petitioner states that,
`according to the ’767 patent, “the term ‘fold’ includes pleats, wings, and any
`similar structure.” Id. (quoting Ex. 1001, 3:62–63). Petitioner further
`asserts that “[t]he specification provides several ‘non-limiting examples of
`methods of balloon folding’ that include reference to ‘lobes,’ ‘wraps,’
`‘wrappings,’ and ‘protrusions.’” Id. In this statement, the Petition cites
`“3:63–4:2” of Exhibit 1001, implying it is quoting the ’767 patent. It is not.
`The Specification of the ’767 patent instead states the following:
`As used in this application, the term “fold” includes pleats,
`wings, and any similar structure. Non-limiting examples of
`methods of balloon folding are discussed in commonly Assigned
`U.S. Patent Application Publication No. 2003/0163157, entitled
`Balloon Folding Apparatus, Methods and Products and U.S.
`Patent Application Publication No. 2005/0251194, entitled
`Curved Wing Balloon and Manufacture Thereof, each of which
`are hereby incorporated by reference in their entirety.
`Ex. 1001, 3:62–4:3. Thus, by citing in the Petition only to the ’767 patent
`Petitioner did not identify what particular document incorporated by
`reference to the ’767 patent Specification refers to ‘lobes,’ ‘wraps,’
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`‘wrappings,’ and ‘protrusions,’ or where in the record of this proceeding
`there is any teaching of ‘lobes,’ ‘wraps,’ ‘wrappings,’ and ‘protrusions’ that
`constitute a “fold,” as that term is used in the ’767 patent. Mr. Trotta
`provides no additional substantive support for Petitioner’s broadest
`reasonable interpretation of “fold.” See Ex. 1005 ¶¶ 64–65 (citing Ex. 1001
`2:5–7, 3:63–4:3).
`Patent Owner, however, does not contest Petitioner’s assertion that
`“fold” encompasses “folds, pleats, wings, lobes, wraps, wrappings, or
`protrusions.” See Prelim. Resp. 6 n.3. The Institution Decision, in the
`absence of any opposition by Patent Owner to Petitioner’s proposed
`construction, stated that for purposes of that decision there was no need to
`expressly construe “fold.” Inst. Dec. 9. Nevertheless, the burden remains on
`Petitioner at all times to show the unpatentability of the challenged claims,
`including the proper claim construction.
`For the following reasons, we find insufficiently supported and
`unreasonably broad Petitioner’s contention that “fold” broadly includes all
`“lobes,” “wraps,” “wrappings,” and “protrusions,” even if those terms
`appear in some context in patent applications incorporated by reference to
`the ’767 patent. Petitioner neither identifies precisely where that context can
`be found in the record of this proceeding nor offers any explanation of that
`context to demonstrate by a preponderance of the evidence that the term,
`reasonably construed in light of the Specification of the ’767 patent, defines
`“fold” as including all “lobes,” “wraps,” “wrappings,” and “protrusions.”
`The mere incorporation by reference of other applications into the
`Specification of the ’767, absent further persuasive explanation, does not
`sufficiently support the proposition that the term “fold” broadly
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`encompasses, for example, any “protrusion.” Moreover, Petitioner provides
`no explanation for why “examples of methods of balloon folding” that
`“reference” the terms “lobes,” “wraps,” “wrappings,” and “protrusions”
`demonstrate that the meaning of “fold” encompasses those terms. Finally,
`the ’767 patent expressly states that the term “fold”’ includes “pleats, wings,
`and any similar structure.” Ex. 1001, 3:62–63. Petitioner, however, makes
`no persuasive showing supported by more than conclusory assertions that all
`“lobes,” “wraps,” “wrappings,” and “protrusions” constitute “similar
`structure” to folds, pleats, or wings. Accordingly, we find the term “fold” in
`the ’767 patent encompasses “pleats, wings, and any similar structure.”
`Thus, “fold” also encompasses lobes, wraps, wrappings, or protrusions (or
`any other feature) only to the extent such feature constitutes “similar
`structure” to folds, pleats, or wings.
`2.
`“balloon cylinder”
`Claim 5 of the ’767 patent, as well as each of challenged claims 6, 9–
`12, 14, and 16–17, recites the term “balloon cylinder.” See, e.g., Ex. 1001,
`7:2. Petitioner contends that a person of ordinary skill would have
`understood “balloon cylinder” to encompass “a preformed balloon shaped to
`include necks.” Pet. 13. In support, Petitioner argues that during
`prosecution of the ’767 patent the examiner characterized a balloon with a
`rounded transition to a neck on each end as meeting the “balloon cylinder”
`limitation. Pet. 12 (citing Ex. 1002, 137–138). Mr. Trotta supports
`Petitioner’s broadest reasonable interpretation of “balloon cylinder.”
`Ex. 1005 ¶¶ 67–71. In particular, we credit Mr. Trotta’s explanation that a
`person of ordinary skill in the art “would have understood that the term
`‘balloon cylinder’ under the broadest reasonable interpretation standard
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`applicable to inter partes review [includes] a tubular structure as well as
`preformed balloons with necks.” Id. at ¶ 67.
`Patent Owner does not contest Petitioner’s assertion that “balloon
`cylinder” encompasses a balloon with necks. See Prelim. Resp. 6 n.3.
`Moreover, we find no evidence in the record to suggest that that the broadest
`reasonable interpretation of “balloon cylinder,” as used in the ’767 patent, is
`limited to a structure that lacks necks. Accordingly, Petitioner has
`persuasively shown that “balloon cylinder,” as used in the ’767 patent,
`encompasses “a preformed balloon shaped to include necks.”
`D.
`SCOPE AND CONTENT OF THE PRIOR ART
`Summary of Dlugos
`1.
`Dlugos, titled “Method of Producing a Balloon of a Balloon
`Catheter,” published February 22, 2007. Ex. 1008, [54], [43]. Dlugos
`generally describes “a method of producing a balloon of a balloon catheter
`having improved folding characteristics.” Ex. 1008, 1–2.9
`The method of Dlugos includes first preparing a balloon body “free of
`any kinds of folds.” Id. at 2. Figure 1 of Dlugos is reproduced below.
`
`
`To show the first step of Dlugos, Figure 1 illustrates balloon 1 with balloon
`body 2, transitional sections 3 and 4, proximal sleeve 5, and distal sleeve 6.
`Id. at 4, 6.
`
`
`9 The original pagination is used in all citations to Dlugos.
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`16
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`Next, Dlugos teaches that “folds are created at least in the distal
`
`sleeve.” Id. at 2. According to Dlugos, “it is also possible to create folds in
`the proximal sleeve, and it is preferred that the folds are created only in the
`sleeves, i.e.[,] that no folds are created in the transition section and/or the
`body,” but Dlugos further states that “the folding must reach into the cone
`(transition section), otherwise a refolding of the balloon is not possible.” Id.
`Dlugos also explains that it is possible to “fold the entire balloon . . . so that
`the folds extend from the sleeves into the transitional section and the body of
`the balloon with the folds being fixed, e.g.[,] by welding, in the distal end or
`proximal balloon sleeve.” Id. at 2–3.
`Figure 2 of Dlugos is reproduced below.
`
`
`To show the second step of Dlugos, Figure 2 illustrates balloon 1 folded
`creating folds 7 “that, in this case, run from the distal sleeve 6, the
`transitional section 4, the balloon body 2, the transitional section 3 to the
`proximal sleeve 5.” Id. at 4. Not shown in Figure 2, a protector can be
`pulled over at least the distal sleeve 6 to pre-fix folds 7. Id. In the final step
`of Dlugos, at least a distal section or portion of the folds of the distal sleeve
`are fixed. Id. at 2.
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`Figure 3 of Dlugos is reproduced below.
`
`
`To show the third step of Dlugos, Figure 3 illustrates folds 7 that are fixed at
`least in the distal section of distal sleeve 6 by welding at the welding/fixing
`portion 8. Id. at 5–6. Dlugos states that it is also possible to fix the folds
`extending into distal sleeve 6 over the entire length of distal sleeve 6.
`Id. at 5. Additionally, Figure 3 illustrates guide wire tube 9, also referred to
`in Dlugos as an “inner tube.” Id. at 3, 6. Dlugos explains that “[t]he inner
`tube is always fixed with the distal sleeve,” and that “the balloon could not
`be inflated” if it were fixed with the proximal sleeve. Id. at 3. Dlugos
`further states that “it is also possible to fix the folds 7 running into proximal
`sleeve 5 in the same manner” as they are shown to be fixed at distal sleeve 6.
`Id. at 5.
`Summary of Eskaros
`2.
`Eskaros, titled “Catheter Balloon with Multiple Micropleats,”
`published April 24, 2008. Ex. 1011, [54], [43]. Eskaros describes “a
`catheter balloon formed of at least one balloon material having a
`longitudinal axis with micropleats distributed about the circumference of the
`balloon resulting in a low profile and an essential symmetry upon inflation.”
`Ex. 1011 ¶ 4.
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`Figures 3 and 4 of Eskaros are reproduced below.
`
`
`
`
`A micropleated catheter is illustrated in an uninflated state in Figure 3 and in
`an inflated stated in Figure 4. Ex. 1011 ¶¶ 8–9. Balloon 2 includes
`micropleats 8 oriented longitudinally over the working length of the balloon.
`Id. ¶ 18. Balloon seal 16, distinct from the inflatable balloon portion, may
`be present on catheter shaft 14. In an inflated state, micropleats 8 pull taut
`such that they are not visible. Id. “The micropleats may be arranged on a
`formed balloon 2 or on a tubular structure of balloon material.” Id.
`3.
`Summary of Hijlkema
`Hijlkema, titled “Balloon Catheter and Method for Manufacturing,”
`issued December 29, 1998. Ex. 1009, [54], [45]. Hijlkema generally relates
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`to manufacturing a balloon catheter, and particularly to a balloon that can be
`properly folded into a small diameter. Ex. 1009, 1:36–39.
`Figures 2 and 3 of Hijlkema are reproduced below.
`
`
`
`
`
`Figure 2 illustrates mold 15 into which tube-like parison or semi-
`manufacture 20 is secured by securing elements 19. Ex. 1009, 3:25–32. The
`semi-manufacture 20 is twisted before being placed in mold 15 and
`expanded under pressure and heat in a blow-molding process to form
`balloon member 9 illustrated in Figure 3. Id. at 3:33–48. The resulting
`balloon member 9 includes ridges of material 22 formed in transition
`
`20
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`sections 11 extending spirally inwardly from end sections 12. Id. at 3:56–
`61. According to Hijlkema, ridges of material 22 “can fold against each
`other, whereby the thinner material in between is folded into pleats,” in a
`manner similar to an umbrella. Id. at 3:65–4:3.
`
`Hijlkema also explains the operation of the balloon catheter. Figures
`5 and 6 of Hijlkema are reproduced below.
`
`
`Figure 5 illustrates a perspective view of balloon member 9 in the folded
`state and Figure 6 illustrates a cross-section of balloon member 9 of Figure 5
`along the line VI–VI. Ex. 1009, 2:58–61. Hijlkema states that “[t]he
`folds 24 fit closely together and substantially coincide with the fan-shaped
`ridges of material 22.” Id. at 4:8–10. In Figure 5, proximal end section 12
`(at the left of the figure) is connected with outer tube-like element 3. Distal
`end section 12 (at the right of the figure) is connected to inner tube-like
`element 4. Outer tube-like element 3 is shorter than inner tube-like
`element 4. As a result, the inside of balloon member 9 is connected to a
`channel between outer tube-like element 3 and inner tube-like element 4,
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`through which a gas or liquid under pressure may be supplied to unfold
`balloon member 9 into its expanded form. Id. at 4:11–24. Petitioner refers
`to such a configuration with inner and outer tube elements as a “coaxial
`balloon catheter.” Pet. 33.
`4.
`Summary of Forman
`Forman, titled “Laser Bonding of Angioplasty Balloon Catheters,”
`generally teaches a process for assembling a balloon catheter involving
`selectively concentrating laser energy. Ex. 1012, Abstract. According to
`Petitioner, “Forman describes using a laser beam 46 or 98 focused at the
`interface between the balloon 90 and catheter tubing 88, with some
`embodiments using heat shrink tubing 92, to weld the balloon to the catheter
`shaft.” Pet. 55–56 (citing Ex. 1012, 7:4–10, 8:18–30, Fig 10).
`5.
`Summary of Traxler
`Traxler, titled “Balloon Wrap Device and Method,” generally teaches
`a method and apparatus for sequentially forming, wrapping, and
`compressing a catheter balloon. Ex. 1013, Abstract. With respect to
`Traxler, Petitioner explains as follows:
`Traxler teaches methods for folding the balloons of
`angioplasty balloon catheters using a balloon wrapping tool
`having bores or channels that progressively compress folds in the
`balloon. Ex. 1013, ¶0015. As illustrated in figure 1 of Traxler,
`a mandrel or guide wire is placed through the balloon wrapping
`tool 10 and the catheter of a balloon catheter is “back loaded”
`onto the mandrel. A sequence of steps involving inflating and
`deflating the balloon mounted to the catheter and advancing the
`catheter through the tool results in the formation of folds in the
`balloon that are then tightly compressed. Id. at ¶0042. The result
`is a more compressed balloon and a reduced profile for the
`balloon catheter than would otherwise be possible. Id. at ¶0001.
`Pet. 60–61.
`
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`Summary of Becker
`6.
`Becker, titled “Method of Radiant Heat Sealing of a Balloon onto a
`Catheter Employing Tinted Shrink Tubing,” generally relates “to providing
`seals along shafts of medical devices by means of radiant energy.”
`Ex. 1014, 1:8–11. The method steps taught by Becker include “the use of
`shrink tubing to hold the balloon in place and simultaneously assist in
`shaping smooth seals, which method includes preshrinking the shrink tubing
`into place.” Id. at 2:18–22; see also Pet. 66–68 (discussing the teachings of
`Becker).
`Summary of Konstantino
`7.
`Konstantino, titled “Balloon Cat
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