Patent No. 7,682,306 B2
`Petition for Inter Partes Review
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`Obalon Therapeutics, Inc.
`Petitioner
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`v.
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`Tilak M. Shah
`Patent Owner
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`Patent No. 7,682,306 B2
`_______________
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`
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`Inter Partes Review No. ______
`____________________________________________________________
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`PETITION FOR INTER PARTES REVIEW
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`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 et seq.
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`sd-690025
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`Petition for Inter Partes Review
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`Obalon Therapeutics, Inc.
`Petitioner
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`v.
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`Tilak M. Shah
`Patent Owner
`
`Patent No. 7,682,306 B2
`_______________
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`
`
`Inter Partes Review No. ______
`____________________________________________________________
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`PETITION FOR INTER PARTES REVIEW
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`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 et seq.
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`Inter Partes Review of USP 7,682,306 B2
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`Docket No. 65925-0000007
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ........................................................................................... 1
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`SUMMARY OF THE ’306 PATENT ............................................................. 3
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`I.
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`II.
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`III. PROSECUTION HISTORY ........................................................................... 6
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`A.
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`Prosecution History of the ’306 Patent ................................................. 6
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`B. Appeal in Prosecution of the ’491 Patent .............................................. 7
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`IV. CLAIM CONSTRUCTION ............................................................................ 8
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`V.
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`IDENTIFICATION OF CHALLENGE .......................................................... 9
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`A. Grounds based on Gau in view of Shah ’915 and Throne .................. 10
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`1.
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`Ground 1: Gau in view of Shah ’915 and Throne renders
`claims 1-3, 5, and 10-14 obvious. ............................................. 10
`a.
`Gau teaches a “flattened spherical” intragastric
`balloon with an inflation element. .................................. 10
`Shah ’915 teaches manufacturing balloons using
`polyurethane film, manufacturing those balloons in
`two half-sections, and welding the two half-
`sections together. ............................................................ 14
`Throne teaches manufacturing multi-layer shapes
`using vacuum thermoforming. ........................................ 19
`One of skill in the art would combine the teachings
`of Gau, Shah ’915, and Throne to arrive at a
`method that includes all the limitations of claims
`1-3, 5, and 10-14. ............................................................ 23
`(i) One of skill in the art would have
`manufactured Gau’s balloon using
`Shah ’915’s polyurethane method because,
`as Shah ’915 teaches, the art recognized
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`b.
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`c.
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`d.
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`TABLE OF CONTENTS
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`Page
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`polyurethane as having many desirable
`properties for medical barrier products. ............... 23
`(ii) One of skill in the art would have used
`Throne’s two-layer approach to manufacture
`Gau’s gastric balloon because, as Throne
`teaches, the approach is a cost-effective
`alternative for providing a gas and moisture
`barrier and reduces waste material. ...................... 24
`(iii) Combining Gau, Shah ’915, and Throne
`leads to predictable results. .................................. 25
`(iv) Manufacturing Gau’s balloon using
`Shah ’915’s and Throne’s teachings renders
`Gau suitable for its intended purpose. .................. 27
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`2
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`Ground 2: Gau in view of Shah ’915, Throne, and Lai
`renders claim 6 obvious. ........................................................... 36
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`
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`B. Grounds based on Connors ................................................................. 38
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`1.
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`b.
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`c.
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`Ground 3: Connors in view of Rakonjac renders claims
`1-8 and 10-16 obvious. ............................................................. 38
`a.
`Connors teaches a spherical, multi-layer balloon
`manufactured from two half-sections. ............................ 38
`Rakonjac teaches balloons manufactured by
`vacuum thermoforming. ................................................. 42
`One of skill in the art would use the vacuum
`thermoforming manufacturing method of Rakonjac
`to manufacture the balloon half-sections of
`Connors to reduce fabrication time and increasing
`economy. ......................................................................... 43
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`2.
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`This Petition presents Connors in a new combination and
`provides new arguments supported by new evidence. .............. 59
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`TABLE OF CONTENTS
`(continued)
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`Page
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`a.
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`b.
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`Petitioner combines Connors with Rakonjac to
`teach a vacuum thermoforming method. ........................ 60
`The Examiner did not present all of Connors’s
`teachings of a multi-layer, spherical balloon
`formed from two half-sections. ...................................... 61
`c. Mr. Strohl’s declaration explains the errors in
`Patent Owner’s declaration. ............................................ 62
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`VI. NOTICES AND STATEMENTS .................................................................. 67
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`VII. CONCLUSION .............................................................................................. 68
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`TABLE OF AUTHORITIES
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`Page
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`CASES
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`Hakim v. Cannon Avent Group, PLC,
`479 F.3d 1313 (Fed. Cir. 2007), ...................................................................... 8
`
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`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999) ............................................................. 8, 9
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`Nat. Steel Car, Ltd. v. Canadian Pac. Ry., Ltd.,
`357 F.3d 1319, 1337 (Fed. Cir. 2004) ........................................................... 18
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`STATUTES
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`35 U.S.C.
`§ 102(a) ........................................................................................ 10, 19, 36, 42
`§ 102(b) ........................................................................................ 10, 14, 19, 42
`§ 102(e) .............................................................................................. 10, 38, 42
`§ 103 .............................................................................................................. 10
`§ 311-319 ......................................................................................................... 1
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`TABLE OF AUTHORITIES
`(continued)
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`Page
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`OTHER AUTHORITIES
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`37 C.F.R.
`§ 1.132 ......................................................................................................... 7, 8
`§ 42.8(b)(1) .................................................................................................... 61
`§ 42.8(b)(2) .................................................................................................... 61
`§ 42.8(b)(3) .................................................................................................... 61
`§ 42.8(b)(4) .................................................................................................... 61
`§ 42.15 ........................................................................................................... 68
`§ 42.100 ........................................................................................................... 1
`§ 42.104(a) ..................................................................................................... 67
`§ 42.104(b) ................................................................................................. 9, 10
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`Exhibit List for Inter Partes Review of U.S. Patent No. 7,682,306 B2
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`Exhibit Description
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`Exhibit #
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`U.S. Patent No. 7,682,306 B2 to Shah
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`Prosecution History of U.S. Patent No. 7,682,306 B2
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`U.S. Patent No. 7,883,491 B2 to Shah
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`Prosecution History of U.S. Patent No. 7,883,491 B2
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`U.S. Patent No. 6,712,832 B2 to Shah
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`U.S. Patent No. 6,976,950 B2 to Connors et al.
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`U.S. Patent No. 5,316,605 to Rakonjac et al.
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`U.S. Patent No. 5,833,915 to Shah
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`“Technology of Thermoforming” by Dr. James L. Throne
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`U.S. Patent No. 5,084,061 to Gau et al.
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`U.S. Patent No. 4,739,758 to Lai et al.
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`Declaration of Clair Strohl
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`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`Petitioner Obalon Therapeutics, Inc. (“Petitioner”) respectfully petitions for
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`inter partes review of claims 1-8 and 10-16 of U.S. Patent No. 7,682,306 B2 (“the
`
`’306 patent” (Ex. 1001)) in accordance with 35 U.S.C. §§ 311-319 and 37 C.F.R.
`
`§ 42.100 et seq.
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`I.
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`INTRODUCTION
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`The ’306 patent’s independent claims (claim 1 and claim 17) each cover a
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`two-step method for introducing a balloon into a physiological locus of a patient:
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`(1) introduce the balloon into the physiological locus and (2) inflate the balloon.
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`No other steps for “introducing a balloon” limit the method.
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`Characteristics of the introduced balloon and the method of manufacturing
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`the balloon also limit the balloon. The balloon includes at least two layers: a first
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`layer to impart “gas barrier character” to the balloon and a second layer of
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`thermoplastic that “alone lacks such gas barrier character.” The balloon includes
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`an inflation element; once inflated, the balloon is “non-pillowed” and generally
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`spherical or flattened spherical. The balloon manufacture entailed vacuum
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`thermoforming two half-sections and bonding those half-sections together along a
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`peripheral seam.
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`Each of these limitations was well known. U.S. Patent No. 5,084,061 to Gau
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`et al. (“Gau” (Ex. 1010)) teaches introducing a balloon into a physiological locus
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`(a gastric cavity) of a patient and inflating the balloon. In fact, Gau teaches that
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`“[a]ll gastric balloons . . . function on th[is] principle.” (Col. 1:21-29.) Gau’s
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`balloon is “non-pillowed,” “flattened spherical,” and includes an inflation element.
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`For manufacturing balloons in two half-sections, Patent Owner’s own U.S. Patent
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`No. 5,833,915 (“Shah ’915” (Ex. 1008)) discloses bonding two half-sections
`
`together along peripheral seams. For multi-layer balloons, “Technology of
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`Thermoforming” by Throne (“Throne” (Ex. 1009)) teaches a multi-layer sheet
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`where one layer provides a sealing function and the other layer does not. Throne
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`further discloses manufacturing the two-layer sheets using vacuum thermoforming.
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`One of skill in the art would have manufactured Gau’s balloon using
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`Shah ’915’s polyurethane method because, as Shah ’915 teaches, those skilled in
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`the art recognized that polyurethane offers many desirable properties for medical
`
`barrier products. Further, one of skill in the art would have used Throne’s two-
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`layer approach to make barrier products because, as Throne teaches, the approach
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`is cost-effective and reduces waste material.
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`Petitioner also presents U.S. Patent No 6,976,950 B2 to Connors et al.
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`(“Connors” (Ex. 1006)) that teaches a therapeutic method involving introducing
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`and inflating a balloon. Connors teaches balloons manufactured from
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`combinations of gas barrier layers, moisture barrier layers, and structural layers.
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`Connors teaches balloons manufactured from two half-sections and bonded along
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`peripheral portions to make seams. Connors does not explicitly teach the vacuum
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`thermoforming process for fabricating the introduced balloon, but U.S. Patent No.
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`5,316,605 to Rakonjac et al. (“Rakonjac”) teaches that vacuum thermoforming two
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`half-sections and bonding them together is “old in the art.”
`
`The Patent and Trademark Office (“PTO”) cited Connors during prosecution
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`of the current patent and its parent, U.S. Patent No. 7,883,491 (the “’491 patent”
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`(Ex. 1003)). To overcome Connors, Patent Owner submitted a declaration from
`
`himself. In a related application, the Board1 reversed the Examiner because the
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`Examiner did not address the same declaration nor explain how Connors’ taught all
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`the limitations of the claims. In addition to presenting Connors with a new
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`reference (Rakonjac) to show vacuum thermoforming, Petitioner presents the
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`testimony of Clair Strohl and supporting evidence to address the relevant portions
`
`of Patent Owner’s declaration. (Declaration of Clair Strohl (Ex. 1012).)
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`II.
`
`SUMMARY OF THE ’306 PATENT
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`The ’306 patent is titled “therapeutic intervention systems employing
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`implantable balloon devices” and includes two independent claims. The
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`’306 patent’s Background describes a need for gas-barrier films in polymeric films
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`less than 25 mils. (Ex. 1001, Col. 1:21-24.) The Background describes many uses
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`1 For simplicity, Petitioner refers to the Patent Trials and Appeals Board and its
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`predecessor, the Board of Patent Appeals and Interferences, as the “Board.”
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`for such gas barrier films, such as containing a specific gas when used to form gas
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`receptacles or when used to isolate an article, structure, material, or region from an
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`adverse gas environment. (Ex. 1001, Col. 1:25-34.) The Background explains that
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`the film may fail in such applications. (Ex. 1001, Col. 1:35-39).
`
`The Summary of Invention provides a number of “aspects of the invention.”
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`(Ex. 1001, Col. 1:53-3:8.) Each aspect includes a multilayer film having a sealing
`
`layer and a thermoplastic layer, where “the sealing film has a composition and
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`thickness imparting gas barrier character to the multilayer film and wherein the at
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`least one layer of thermoplastic polymer film alone lacks such gas barrier
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`character.” (Ex. 1001, Col. 1:57-67, 2:11-19, 2:30-39, 2:41-52, 2:61-3:4.)
`
`Figure 1 depicts a multilayer extruded laminate film 10 including inner
`
`sealing layer film 12 and outer film layers 14 and 16. (Ex. 1001, Col. 7:1-6.)
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`Figure 3 depicts a vacuum thermoforming assembly 50 with a generally
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`hemispherical cavity 54. (Ex. 1001, Col. 8:18-23.) A vacuum source (not shown)
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`extracts gas through withdrawal passages on the surface 60 of the cavity through a
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`gas extraction plenum 56 and discharge passage 58. (Id. at Col. 8:23-30.) The
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`process includes heating multilayer film 62 to sufficient temperature for vacuum
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`thermoforming and applying a vacuum to assembly 50 so that the film conforms to
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`cavity surface 60. (Id. at Col. 8:45-53.)
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`After forming the first and second half-sections, the process superimposes
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`the two sections and bonds them together at the sections’ margins. (Ex. 1001, Col.
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`8:62-67.) Figure 4 provides an exemplary frequency welding method where two
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`sheets 62 and 64 lie in a cavity 82 and a radio frequency die 70 contacts the two
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`sheets to bond the sheets circumferentially. (Ex. 1001, 9:1-11.)
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`III. PROSECUTION HISTORY
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`A.
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`Prosecution History of the ’306 Patent
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`The ’306 patent matured from U.S. Application No. 11/554,550 (the
`
`“’550 Application” (Ex. 1002)) filed on October 30, 2006 with a priority claim to
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`U.S. Application No. 10/815,282. (Ex. 1001, Cover Page.)
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`On May 12, 2009, the PTO rejected all claims over Connors. (Ex. 1002,
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`Non-Final Rejection, mailed 05/12/09, Pages 2-5.) Patent Owner responded on
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`August 12, 2009 and relied upon his own declaration. (Ex. 1002, Response to
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`Non-Final Rejection, filed August 12, 2009.) An Examiner Interview, Notice of
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`Allowance, and Examiner’s Amendment followed in December 2009. (Ex. 1002,
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`Notice of Allowance, mailed December 14, 2009.) The ’306 patent issued on
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`March 23, 2010. (Ex. 1001, Cover Page.)
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`A detailed description of the prosecution history is included with the
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`Declaration of Mr. Strohl. (Ex. 1012.)
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`B. Appeal in Prosecution of the ’491 Patent
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`Patent Owner filed the same declaration during prosecution of the
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`’491 patent. The Examiner rejected all pending claims over Connors, Patent
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`Owner appealed the rejection, and the Board reversed.
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`In reversing, the Board faulted the Examiner for inadequate analysis. The
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`Board found that the “Examiner has not specifically articulated in the Answer how
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`Connors otherwise discloses or suggests, to one of ordinary skill in the art, how to
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`construct a balloon with all of the characteristics required by each of the appealed
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`claims.” (Ex. 1004, Appeal Decision, Mailed 08/18/2010, Page 5.)
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`The Board also faulted the Examiner’s failure to consider Patent Owner’s
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`declaration. Specifically, the Board held that “the Examiner’s failure to address
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`and attempt to discredit the 37 CFR § 1.132 Declaration testimony of [Patent
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`Owner] employed in support of Appellant’s arguments . . . of itself, warrants
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`reversal of the stated rejection.” (Ex. 1004, Appeal Decision, Mailed 08/18/2010,
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`Page 5.)
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`The Board concluded:
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`In sum and as correctly urged by Appellants, the Examiner does
`not reasonably explain how the referred to Patent Specification
`passages of Connors taken with the depicted embodiments
`represented in Figures 5 and 16C teach or suggest a balloon
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`having all of the claimed characteristics to an ordinary skilled
`artisan given the additional non-rebutted information provided
`in the 37 C.F.R. § 1.132 Declaration testimony of [Patent
`Owner].
`
`The aforementioned failure on the part of the Examiner
`represents a dispositive issue that we resolve in Appellant's
`favor.
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`(Ex. 1004, Appeal Decision, Mailed 08/18/2010, Page 5.)
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`IV. CLAIM CONSTRUCTION
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`The ’306 patent provides two explicit definitions:
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`As used herein, the term “film” means a material in a sheet or web
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`form, having a thickness of 50 mils (1.270 mm) or less.
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`As used herein, the term “extrusion laminated” in reference to a film
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`of thermoplastic material means that such film of thermoplastic
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`material is deposited as an extruded melt film on (one or both sides
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`of) the sealing layer film, so that the respective thermoplastic material
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`and sealing layer films are consolidated with one another under
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`elevated temperature conditions.
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`(Ex. 1001, Col. 3:9-21.)
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`Petitioner does not submit any other claim constructions. Petitioner relies on
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`the plain language of the claims and embodiments in the ’306 patent to
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`demonstrate that the prior art meets the limitations of the ’306 patent. Hakim v.
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`Cannon Avent Group, PLC, 479 F.3d 1313 (Fed. Cir. 2007) (“When there is no
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`dispute as to the meaning of a term that could affect the disputed issues of the
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`litigation, ‘construction’ may not be necessary.”); see also Vivid Techs., Inc. v. Am.
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`Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that only those
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`terms that are in controversy need to be construed and only to the extent necessary
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`to resolve the controversy).
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`V.
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`IDENTIFICATION OF CHALLENGE
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`Pursuant to 37 C.F.R. § 42.104(b), Petitioner respectfully requests the Board
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`cancel claims 1-8 and 10-16 of the ’306 patent.
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`The ’306 patent combines known features of intragastric balloons with
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`known thermoplastic manufacturing processes. Gau, for example, teaches all the
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`gastric balloon limitations recited in independent claim 1. Throne and Shah ’915
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`teach the thermoplastic manufacturing techniques recited in independent claim 1.
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`One or more of Gau, Throne, and Shah ’915 teach the additional limitations for
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`many dependent claims.
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`Connors teaches all limitations of independent claim 1, except
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`manufacturing a balloon by vacuum thermoforming; Rakonjac teaches
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`manufacturing a balloon by vacuum thermoforming. The PTO cited Connors and
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`the Board reversed the Examiner in the ’491 patent. As explained below, Connors
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`and Rakonjac, in conjunction with the evidence presented, addresses the Board’s
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`findings on appeal: Petitioner newly offers Rakonjac for vacuum thermoforming,
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`and Petitioner provides an expert declaration and supporting evidence to address
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`the declaration provided by Patent Owner during prosecution.
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`The table below sets forth the statutory grounds for the challenge (all
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`statutory citations are pre-AIA).
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`Ground
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`35 U.S.C. Reference
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`Claims
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`Ground 1 § 103
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`Gau, Shah ’915, Throne
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`Claims 1-3, 5, and
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`Ground 2 § 103
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`Gau, Shah ’915, Throne, Lai
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`Claim 6
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`10-14
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`Ground 3 § 103
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`Connors, Rakonjac
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`Claims 1-8 and 10-16
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`Pursuant to 37 C.F.R. § 42.104(b), Petitioner respectfully requests the Board
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`cancel of claims 1-8 and 10-16 of the ’306 patent.
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`A. Grounds based on Gau in view of Shah ’915 and Throne
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`1. Ground 1: Gau in view of Shah ’915 and Throne renders
`claims 1-3, 5, and 10-14 obvious.
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`a. Gau teaches a “flattened spherical” intragastric
`balloon with an inflation element.
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`Gau issued on January 28, 1992, claiming priority to an application filed on
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`September 25, 1987. (Ex. 1010, Cover Page.) Gau qualifies as prior art to the
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`’306 patent under 35 U.S.C. § 102(a), 35 U.S.C. § 102(b), and 35 U.S.C. § 102(e).
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`Neither Patent Owner nor the PTO cited Gau during the prosecution of the
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`’306 patent.
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`Gau relates to implantable weight control devices. (Ex. 1010, Col. 1:13-14.)
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`Gau notes that existing gastric devices are typically spherical, which can present a
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`challenge to surgeons manipulating the device in the gastric cavity. (Ex. 1010,
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`Col. 2:8-14.) To address this challenge, Gau offers a flattened spherical balloon
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`allowing for “relative ease with which the important components of the balloon 20
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`can be visualized and manipulated while . . . in the stomach.” (Ex. 1010, Col.
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`7:39-41; see also id. at Col. 4:28-43; Figure 1 (reproduced below).)
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`Gau’s gastric balloon also includes a self-sealing valve (element 28, Figure 2
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`reproduced below), a fill tube guide (element 54, Figure 2 reproduced below), and
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`a removal tab (element 64, Figure 2 reproduced below).
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`“The purpose of the valve 28 is to permit inflation of the balloon 20 after it
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`has been inserted into the stomach 26, and also its deflation before it is desired to
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`remove the balloon 20 from the stomach 26.” (Ex. 1010, Col. 4:57-60.) “The
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`purpose of the fill tube guide 54 is to serve as a seat for the stiffening rod or
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`stylette (not shown) which is used to make the fill tube and balloon rigid during the
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`original insertion of the balloon 20 into the stomach 26.” (Ex. 1010, Col. 6:51-55.)
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`“The purpose of the tab 64 is to provide means through which the balloon 20 can
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`be relatively easily captured or grasped after full or partial deflation and removed
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`from the stomach 26.” (Ex. 1010, Col. 7:2-5.)
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`The process includes mounting the balloon by passing a fill tube and stylette
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`through the valve 28 and then seating the stylette in the fill tube guide. (Ex. 1010,
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`Col. 6:57-60.) The balloon 20 “is placed into the stomach in a non-inflated form,
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`and is filled after insertion with a suitable fluid, such as saline solution.” (Ex.
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`1010, Col. 3:62-65.) The balloon can then be deflated by passing a filler tube
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`through the valve 28. (Col. 5:19-23.)
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`As described above, Gau teaches introducing a balloon into a physiological
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`locus of a patient and inflating the balloon. Gau also provides a balloon is
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`non-pillowed and “generally spherical or flattened spherical.” Although the
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`’306 patent does not define those terms, during prosecution of the related ’491
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`patent, Patent Owner referred to the following shape as “a non-pillowed, spheroid”
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`and stated that the “balloon pictured in Exhibits B1-B3 corresponds to the claims
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`of the instant application.”2 (Ex. 1004, Appeal Brief, filed March 20, 2008,
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`Declaration of T. Shah, Paragraph 11 & Exhibit B1-B3; see also Ex. 1002,
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`Response to Office Action, filed August 12, 2009 (referencing the declaration in
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`distinguishing Connors).)
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`The balloon in Gau has a shape similar to the “non-pillowed, spheroid”
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`shape in the image above, except slightly “flattened” in one plane (see Gau Figures
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`1 and 2 below) to produce a “non-pillowed3, flattened spherical” balloon.
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`(Ex. 1012, ¶ 45.)
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`2 The claims of the ’491 patent include the limitation “a balloon that in an inflated
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`state is non-pillowed and spheroidal in shape.” (Ex. 1004, Response to February
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`22, 2007 Final Office Action, Filed April 23, 2007, Page 3.)
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`3 The ’306 patent does not provide guidance on the term “non-pillowed.” The only
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`mention of the term is in claims 1 and 17, and then a statement that vacuum
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`b.
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`Shah ’915 teaches manufacturing balloons
`using polyurethane film, manufacturing those
`balloons in two half-sections, and welding the
`two half-sections together.
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`Shah ’915 issued on November 10, 1998, and qualifies as prior art under
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`35 U.S.C. § 102(b). Shah ’915 is titled “Method of Welding Polyurethane Thin
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`Film.”
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`Shah ’915 discloses the use of a polyurethane film
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`Shah ’915 generally teaches “[a] method of welding at least two layers of a
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`thin thermoplastic polyurethane elastomer . . . to form a weld seam . . . to produce
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`thermoforming two half-sections together can result in a non-pillowed balloon.
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`(Ex. 1001; Col. 4:19-23.) As explained in the sections below, Petitioner proposes
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`combining Throne with Gau for a vacuum thermoformed balloon.
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`During prosecution, Patent Owner declared that certain images (as explained
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`herein) were “non-pillowed.” As shown herein, Gau’s shape is essentially the
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`same as the shape of the balloons described by Patent Owner as non-pillowed.
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`polyurethane barrier products.” (Ex. 1008, Abstract.) Shah ’915 notes that the art
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`recognized the benefits of using polyurethane before the filing date of the
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`’306 patent: “It has been recognized that polyurethane polymers have properties
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`desirable for many of the rubber goods heretofore made of natural rubber,
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`particularly thermoplastic elastomer polyurethanes.” (Ex. 1008, Col. 2:43-46.)
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`Shah ’915 further teaches exemplary benefits for polyurethane products
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`manufactured according to its method: “The products of this new method have
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`high integrity, and are free from wrinkles, pin holes, holidays, burns or charring,
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`mandatory in devices of this class.” (Ex. 1008, Col. 5:13-16.)
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`As noted above, the ’306 patent defines “film” to be “a material in a sheet or
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`web form, having a thickness of 50 mils (1.270 mm) or less.” Shah ’915’s
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`polyurethane layers are “0.5 to 5.0 mils” thick, and Shah ’915 refers to the layers
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`as “thin polyurethane film.” (Ex. 1008, Col. 3:5-9.) Shah ’915 therefore teaches
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`the use of a film, as required by all claims, and a polyurethane film, as required by
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`dependent claim 10. (Ex. 1012, ¶ 54.)
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`Shah ’915 teaches the manufacture of balloons in two half-sections
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`Shah ’915 teaches balloon manufacture explicitly: “FIG. 7 is a view of [a]
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`non-inflated thermoplastic polyurethane elastomer balloon cuff of an in-dwelling
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`urinary bladder catheter. FIG. 8 is an inflated thermoplastic polyurethane
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`elastomer balloon cuff of an in-dwelling urinary bladder catheter.” (Ex. 1008,
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`Col. 5:27-61.) Shah ’915 Figures 7 and 8 are reproduced below, with the balloon
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`highlighted:
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`
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`Figures 7 and 8 illustrate a balloon manufactured from two halves, 46A and
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`46B joined at weld seam 44. (Col. 11:54-57.) Shah ’915 illustrates the seam in a
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`solid double-line 44 on the front portion (as viewed in Figures 7 and 8) and
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`illustrates the seam as a dashed line on the rearward portion. (Ex. 1012, ¶ 55-56.)
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`In figures for other embodiments (e.g., Figures 4-6 and 9-11), Shah ’915 uses the
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`same solid double-lines to depict viewable seams and dashed lines to depict
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`non-viewable seams. (Id.) The seams depict the joining line for the two half-
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`sections of the balloons. (Id.)
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`Shah ’915 discloses methods of bonding the two half-sections
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`Shah ’915 also teaches bonding two half-sections together, as required by
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`the claims of the ’306 patent. (Id., 51.) According to Shah ’915, known
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`techniques join polyurethanes using bonding or welding, but those techniques have
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`resulted in “wrinkles, pin holes, discontinuities, holidays and burn or charring
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`defects.” (Ex. 1008, Col. 2:64-3:8.) Shah ’915’s solution to the prior art problems
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`is a method for “highly efficient R.F. welding of thermoplastic polyurethane
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`elastomers.” (Ex. 1008, Col. 5:21-22.) The R.F. welding method includes
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`“heating the polymer to a temperature above the Vicat softening temperature (but
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`below the heat distortion temperature or film distortion temperature), and
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`subjecting the heated polymers to be joined to R.F. energy and pressure.”
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`(Ex. 1008, Col. 5:22-26.) Shah ’915’s technique is “particularly useful for joining
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`thin films of the polyurethane” (Ex. 1008, Col. 5:26-28) but “the technique is
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`equally applicable to thicker films and other forms of such polymers.” (Ex. 1008,
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`Col. 6:66-7:1.)
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`Although Shah ’915 mainly discusses welding “layers,” Shah ’915 also
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`discloses welding edges, as required by the claims of the ’306 patent. (Ex. 1012, ¶
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`57.) The figures of Shah ’915 consistently depict the seam on the edge. (See, e.g.,
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`Ex. 1008, Figures 4-11 and 13; Ex. 1012.) Further, Shah ’915 notes those in the art
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`generally prefer “weld[ing] only at the seam areas and their immediate vicinity”
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`since seam-welding “minimiz[es] the heat input.” (Ex. 1008, Col. 8:22-25.) Thus,
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`Shah ’915 teaches welding on an edge because Shah ’915 depicts the seam on the
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`edge and notes that those of skilled in the art preferred seam welding. (Ex. 1012,
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`¶¶ 57-58.)
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`As described below in Section V.A.1.c, Patent Owner argued during
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`prosecution that one of skill in the art could not produce non-pillowed balloons
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`without vacuum thermoforming. In Shah ’832, Patent Owner argued something
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`else: that RF welding technique results in a “non-pillowed” balloon.4 (Ex. 1005,
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`Col. 2:20-25 (“Film welding methods . . . also experience difficulties. Inflation of
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`such catheter balloons is usually non-uniform, due to ‘pillowing’ or so-called
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`‘pillow effect.’).) Shah ’915 teaches R.F. welding (Ex. 1008, Col. 3:21-29), the
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`same bonding technique5 taught in Shah ’832 (Ex. 1005, Col. 3:63-4:3).
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`4 During prosecution, Patent Owner argued that Shah ’832 published after the
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`’306 patent’s filing date. Patent Owner is mistaken; Shah ’832 was publically
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`available for almost one year. Although this means that Shah ’832 is not available
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`as prior art, it “has long been the law that the motivation to combine need not be
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`found in prior art references, but equally can be found in the knowledge generally
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`available to one of ordinary skill in the art.” Nat. Steel Car, Ltd. v. Canadian Pac.
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`Ry., Ltd., 357 F.3d 1319, 1337 (Fed. Cir. 2004) (internal citations omitted).
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`5 Shah ’832 incorporates Shah ’915 by reference for the R.F. weldin
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