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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`Filed on behalf of Becton, Dickinson and Company
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`By: Heather M. Petruzzi, Reg. No. 71,270 (Lead Counsel)
` Wilmer Cutler Pickering Hale and Dorr LLP
`
` 1875 Pennsylvania Avenue, NW
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` Washington, DC 20006
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`Tel: (202) 663-6000
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`Email: Heather.Petruzzi@wilmerhale.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`
`
`BECTON, DICKINSON AND COMPANY,
`Petitioner,
`
`v.
`
`B. BRAUN MELSUNGEN AG,
`Patent Owner of
`U.S. Patent No. 8,333,735 to Woehr et al.
`
`IPR Trial No. IPR2017-01583
`
`
`PETITION FOR INTER PARTES REVIEW
`OF CLAIMS 1, 9, 10, 11, 18, 19, 24 OF U.S. PATENT NO. 8,333,735
`UNDER 35 U.S.C. §312 AND 37 C.F.R. §42.104
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`Table of Contents
`Introduction ...................................................................................................... 1 
`I. 
`II.  Mandatory Notices ........................................................................................... 1 
`A. 
`Real Parties in Interest ........................................................................... 1 
`B. 
`Related Matters ...................................................................................... 1 
`C. 
`Counsel .................................................................................................. 1 
`D. 
`Service Information ............................................................................... 2 
`III.  Certification of Grounds for Standing ............................................................. 2 
`IV.  Overview of Challenge and Relief Requested ................................................. 2 
`A.  Grounds of Challenge ............................................................................ 2 
`B. 
`Relief Requested .................................................................................... 3 
`V.  Overview of the’735 Patent ............................................................................. 3 
`A. 
`State of the Art ...................................................................................... 3 
`B. 
`Brief Description of the ’735 Patent in View of the State of the Art .... 4 
`VI.  POSA ............................................................................................................... 6 
`VII.  Claim Construction .......................................................................................... 6 
`A. 
`“needle protective device” .................................................................... 7 
`VIII.  Ground I: The Challenged Claims Are Obvious over Woehr ’108 in view of
`Tauschinski, and further in view of Arnett. ..................................................... 9 
`A. 
`Independent Claim 1 ........................................................................... 11 
`1. 
`Element 1p. “A catheter insertion device comprising:” . 11 
`2. 
`Element 1a. “a catheter hub…;” ..................................... 11 
`3. 
`Element 1b. “a needle…;” .............................................. 12 
`4. 
`Element 1c. “a valve…;” ................................................ 13 
`5. 
`Element 1d. “a valve actuating element…;” .................. 16 
`6. 
`Element 1e. “a needle protective device….” .................. 21 
`Dependent Claim 9 .............................................................................. 23 
`Independent Claim 10 ......................................................................... 24 
`1. 
`Element 10p. “A catheter insertion device comprising:”
` ........................................................................................ 24 
`
`B. 
`C. 
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`2. 
`Element 10a. “a catheter hub…;” ................................... 24 
`Element 10b. “a needle…;” ............................................ 25 
`3. 
`Element 10c. “a valve…;” .............................................. 25 
`4. 
`Element 10d. “a valve actuating element…;” ................ 26 
`5. 
`Element 10e. “a needle protective device….” ................ 27 
`6. 
`D.  Dependent Claim 11 ............................................................................ 28 
`E. 
`Independent Claim 18 ......................................................................... 29 
`1. 
`Element 18p. “A catheter insertion device comprising:”
` ........................................................................................ 29 
`Element 18a. “a catheter hub…;” ................................... 29 
`2. 
`Element 18b. “a needle…;” ............................................ 31 
`3. 
`Element 18c. “a valve…;” .............................................. 31 
`4. 
`Element 18d. “a valve actuating element…;” ................ 31 
`5. 
`Element 18e. “a needle protective device….” ................ 32 
`6. 
`Dependent Claim 19 ............................................................................ 32 
`F. 
`G.  Dependent Claim 24 ............................................................................ 33 
`IX.  Ground II: The Challenged Claims Are Obvious over Van Heugten in view
`of Arnett. ........................................................................................................ 34 
`A. 
`Independent Claim 1 ........................................................................... 35 
`1. 
`Element 1p. “A catheter insertion device comprising:” . 35 
`2. 
`Element 1a. “a catheter hub…;” ..................................... 35 
`3. 
`Element 1b. “a needle…;” .............................................. 36 
`4. 
`Element 1c. “a valve…;” ................................................ 37 
`5. 
`Element 1d. “a valve actuating element…;” .................. 39 
`6. 
`Element 1e. “a needle protective device….” .................. 42 
`Dependent Claim 9 .............................................................................. 43 
`Independent Claim 10 ......................................................................... 44 
`1. 
`Element 10p. “A catheter insertion device comprising:”
` ........................................................................................ 44 
`Element 10a. “a catheter hub…;” ................................... 44 
`Element 10b. “a needle…;” ............................................ 44 
`
`B. 
`C. 
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`2. 
`3. 
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`Petition for Inter Partes Review
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`4. 
`Element 10c. “a valve…;” .............................................. 44 
`Element 10d. “a valve actuating element…;” ................ 46 
`5. 
`Element 10e. “a needle protective device….” ................ 47 
`6. 
`D.  Dependent Claim 11 ............................................................................ 48 
`E. 
`Independent Claim 18 ......................................................................... 49 
`1. 
`Element 18p. “A catheter insertion device comprising:”
` ........................................................................................ 49 
`Element 18a. “a catheter hub…;” ................................... 49 
`2. 
`Element 18b. “a needle…;” ............................................ 51 
`3. 
`Element 18c. “a valve…;” .............................................. 51 
`4. 
`Element 18d. “a valve actuating element…;” ................ 51 
`5. 
`Element 18e. “a needle protective device….” ................ 52 
`6. 
`Dependent Claim 19 ............................................................................ 53 
`F. 
`G.  Dependent Claim 24 ............................................................................ 53 
`X.  Ground III: The Challenged Claims Are Obvious over Pike in View of
`Luther. ............................................................................................................ 54 
`A. 
`Independent Claim 10 ......................................................................... 55 
`1. 
`Element 10p. “A catheter insertion device comprising:”
` ........................................................................................ 55 
`Element 10a. “a catheter hub…;” ................................... 56 
`2. 
`Element 10b. “a needle…;” ............................................ 57 
`3. 
`Element 10c. “a valve…;” .............................................. 57 
`4. 
`Element 10d. “a valve actuating element…;” ................ 61 
`5. 
`Element 10e. “a needle protective device….” ................ 64 
`6. 
`Dependent Claim 11 ............................................................................ 65 
`Independent Claim 18 ......................................................................... 67 
`1. 
`Element 18p. “A catheter insertion device comprising:”
` ........................................................................................ 67 
`Element 18a. “a catheter hub…;” ................................... 67 
`Element 18b. “a needle…;” ............................................ 68 
`Element 18c. “a valve…;” .............................................. 68 
`
`2. 
`3. 
`4. 
`
`B. 
`C. 
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`5. 
`Element 18d. “a valve actuating element…;” ................ 69 
`Element 18e. “a needle protective device….” ................ 71 
`6. 
`D.  Dependent Claim 19 ............................................................................ 72 
`E. 
`Dependent Claim 24 ............................................................................ 72 
`XI.  Ground IV: Claim 9 is Obvious over Van Heugten in view of Arnett, and
`further in view of Greene. .............................................................................. 73 
`A. 
`Independent Claim 1 ........................................................................... 74 
`B. 
`Dependent Claim 9 .............................................................................. 74 
`XII.  Secondary Considerations of Nonobviousness Do Not Negate the Above
`Obviousness Grounds. ................................................................................... 76 
`XIII.  Conclusion ..................................................................................................... 76 
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`– v –
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`TABLE OF AUTHORITIES
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`Page(s)
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`
`CASES
`Adlens USA, Inc. v. Superfocus Holdings LLC,
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`2016 WL 7992047 (Dec. 27, 2016) ................................................................. 7
`
`Micron Tech., Inc. v. Innovative Memory Sys., Inc.,
`
`2016 WL 5027747 (June 13, 2016) ................................................................. 8
`
`MIT & Elecs. for Imaging, Inc. v. Abacus Software,
`462 F.3d 1344 (Fed. Cir. 2006) ....................................................................... 8
`
`
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) .................................................................. 7, 8
`
`
`RULES
`Rule 42.104 ................................................................................................................ 2
`Rule 42.22 .................................................................................................................. 2
`STATUTES AND REGULATIONS
`37 C.F.R. § 42.100 ..................................................................................................... 6
`37 C.F.R. § 42.104 ..................................................................................................... 9
`56 Fed. Reg. 64004 (Dec. 6, 1991) ............................................................................ 3
`35 U.S.C. § 102 ........................................................................................ 9, 34, 55, 73
`35 U.S.C. § 103 ...................................................................................................... 2, 3
`35 U.S.C. § 112 ........................................................................................ 7, 34, 54, 73
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`I.
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`Introduction
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`Petitioner Becton, Dickinson and Company requests institution of an inter
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`partes review to cancel claims 1, 9, 10, 11, 18, 19, 24 (“Challenged Claims”) of
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`U.S. Patent No. 8,333,735 (“the ’735 patent”). For the reasons set forth below,
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`there is a reasonable likelihood that the Challenged Claims are unpatentable as
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`obvious.
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`II. Mandatory Notices
`A. Real Parties in Interest
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`Becton, Dickinson and Company and Becton Dickinson Infusion Therapy
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`Systems, Inc. are real-parties-in-interest.
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`B. Related Matters
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`The Challenged Claims have been asserted against Petitioner in B. Braun
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`Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D.
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`Del.) Additionally, IPRs are being filed on U.S. Patent Nos. 8,328,762; 8,337,463;
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`8,540,728; 9,149,626; 8,597,249; 8,460,247; and 9,370,641
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`C. Counsel
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`Lead Counsel:
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`Heather M. Petruzzi (Reg. No. 71,270)
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`Back-up Counsel:
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`Natalie Pous (Reg. No. 62,191)
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`David L. Cavanaugh (Reg. No. 36,476)
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`D.
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`Service Information
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`Email:
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`Heather.Petruzzi@wilmerhale.com;
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`Natalie.Pous@wilmerhale.com;
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`David.Cavanaugh@wilmerhale.com;
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`Post & Hand
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`Wilmer Cutler Pickering Hale and Dorr LLP
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`Delivery:
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`1875 Pennsylvania Avenue NW, Washington, DC 20006
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`Tel: (202) 663-6000, Facsimile: (202) 663-6363
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`Petitioner agrees to accept service by email.
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`III. Certification of Grounds for Standing
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`Petitioner certifies pursuant to Rule 42.104(a) that the patent for which
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`review is sought is available for inter partes review and that Petitioner is not
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`barred or estopped from requesting an inter partes review on the grounds identified
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`in this Petition.
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`IV. Overview of Challenge and Relief Requested
`A. Grounds of Challenge
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`Under Rules 42.22(a)(1) and 42.104(b)(1)(2), Petitioner requests
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`cancellation of claims 1, 9-11, 18-19, 24 of the ’735 patent as unpatentable under
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`35 U.S.C. §103 based on the following grounds.
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`Ground 35 U.S.C. § Claims
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`References
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`I
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`103
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`II
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`III
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`IV
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`103
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`103
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`103
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`1, 9-11,
`18-19, 24
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`1, 9-11,
`18-19, 24
`10-11,
`18-19, 24
`9
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`Woehr ’108 in view of Tauschinski, and
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`further in view of Arnett
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`Van Heugten in view of Arnett
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`Pike in view of Luther
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`Van Heugten in view of Arnett, and
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`further in view of Greene
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`B. Relief Requested
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`Petitioner requests that the Board cancel the Challenged Claims because
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`they are unpatentable under 35 U.S.C. §103.
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`V. Overview of the’735 Patent
`A.
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`State of the Art
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`Since at least the 1980s, catheter insertion assemblies have been designed to
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`include needle safety to minimize the potential of healthcare workers being stuck
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`by needles. (Ex.1002, Declaration of Jack Griffis (“Decl.”) ¶¶31-34.) In addition
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`to many books, papers, and patents that identified the need for needle safety and
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`suggested designs to achieve it, Congress also recognized this need. (Id.) The
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`1991 OSHA Bloodborne Pathogens Standard, 56 Fed. Reg. 64004 at 64114 (Dec.
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`6, 1991) identified “self-sheathing needles” as an engineering control to reduce
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`– 3 –
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`employee exposure to hazardous pathogens. (Id.) In 2000, the Needlestick Safety
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`and Prevention Act recognized that “the use of safer medical devices, such as
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`needleless systems and sharps with engineered sharps injury protections, when
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`they are part of an overall bloodborne pathogens risk-reduction program, can be
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`extremely effective in reducing accidental sharps injuries.” (Ex. 1021, Needlestick
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`Safety and Prevention Act, Pub. L. No. 106-430, 114 Stat. 1901, 1902 (2000).)
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`It was also recognized, for example in U.S. Patent No. 5,053,014 (“Van
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`Heugten”) (Ex.1006), that during use of an I.V. catheter assembly, it is desirable to
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`minimize “any blood leakage from the assembly so as to reduce the risk of
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`transmitting blood-borne diseases to medical personnel.” (Ex.1006, Van Heugten
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`at 1:15-18.)
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`B.
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`Brief Description of the ’735 Patent in View of the State of the Art
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`The ’735 patent was filed on April 19, 2012, and claims priority to a German
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`patent application filed on July 4, 2002. The ’735 patent describes an over-the-
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`needle catheter insertion device. Figure 1 is shown below:
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`– 4 –
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`The ’735 patent recognizes that catheter assemblies including a catheter hub,
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`a needle guard element, and a hollow needle that engages with a needle guard
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`element were known. (Ex.1001, ’735 patent at 1:24-29.)
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`The ’735 patent identifies two objectives for the disclosed catheter
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`assembly: (1) prevent an outflow of blood from the catheter after removal of the
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`hollow needle; and (2) cover the tip of the needle as the needle is withdrawn so
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`that operating personnel cannot injure themselves on the needle tip. (Ex.1001,
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`’735 patent at 1:40-49.) These “objectives” were also well known in the art.
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`(Ex.1002, Decl. ¶35-40; Ex.1006, Van Heugten at claim 1.)
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`The ’735 patent accomplishes blood control by a check valve that seals as
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`the needle is withdrawn from the catheter hub, but can be opened when an external
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`force pushes a valve actuating element in a distal direction. (Ex.1001, ’735 patent
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`at 2:41-56.) By 2002, catheter insertion devices that included check valves and
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`valve actuating elements to prevent blood leakage were well known. (Ex.1002,
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`Decl. ¶¶46-47.) In order to cover the needle tip to prevent injury, the ’735 patent
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`discloses a spring clip that closes around the needle tip as it is withdrawn from the
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`catheter hub. (Ex.1001, ’735 patent at 2:33-41.) The same spring clip disclosed in
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`the ’735 patent was also known as of 2002. (Ex.1002, Decl. ¶50, 82-83.) Further,
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`catheter insertion devices with the combination of blood control and needle
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`protection were well known by 2002. (Id.)
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`VI. POSA
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`A person of ordinary skill in the art (“POSA”) in 2002 would have been
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`either a (i) a medical practitioner with experience using vascular access devices
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`and with training, experience and/or familiarity applying principles of engineering
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`to the design, development, and/or testing of vascular access devices, or (ii) an
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`engineer having at least a bachelor of science degree and with several years of
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`experience in the design, development, and/or testing of vascular access devices
`
`and their clinical use; a higher level of education could reduce the number of years
`
`of experience required. (Ex.1002, Decl. ¶¶28-30.)
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`VII. Claim Construction
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` Generally in an inter partes review, the Board construes claim terms in an
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`unexpired patent according to their broadest reasonable construction in light of the
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`specification of the patent in which they appear. 37 C.F.R. § 42.100(b).
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`A.
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`“needle protective device”
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`A claim term defined by the performance of a function that does not recite
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`sufficient structure for performing the function is construed under 35 U.S.C. § 112,
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`¶ 6. (Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (en
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`banc).) In Williamson, the Federal Circuit held that there was no “heightened
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`evidentiary showing” to overcome the presumption that a claim phrase that does
`
`not use the term “means” is not governed by § 112, ¶ 6. (Id. at 1349.) Instead,
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`“[where] the claim term fails to ‘recite sufficiently definite structure’ or else recites
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`‘function without reciting sufficient structure for performing that function,’” the
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`claim is governed by § 112, ¶ 6 whether or not the word “means” is used. (Id. at
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`1348; see also Adlens USA, Inc. v. Superfocus Holdings LLC, 2016 WL 7992047,
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`IPR2016–01824, Paper 42 (Final Decision) at *4 (Dec. 27, 2016).)
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`Once it is determined that a claim term is a means-plus-function term, a two-
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`step analysis under § 112, ¶ 6 applies. (Williamson, 792 F.3d at 1351-52.) The
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`first step identifies the claimed function. (Id.) The second step identifies the
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`structure in the patent specification that performs the claimed function. (Id.) The
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`claim term is construed to cover those structures and all equivalents thereof. (Id.)
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`Claims 1, 9-11, 18-19, 24 recite “a catheter insertion device comprising. . . a
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`needle protective device . . . to prevent unintended needle sticks.” The use of the
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`word “device” in the claims does not impart any structure and is tantamount to
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`using the word “means.” (Williamson, 792 F.3d at 1350.) The term “needle
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`protective device” is not used, nor is it defined, in the specification of the ’735
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`patent.
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`The Board may look to the modifiers of a nonce term to see if they impart
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`structure. (Williamson, 792 F.3d at 1351.) If the modifier has no dictionary
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`definition and no generally understood structural meaning in the art, then the term
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`is a means-plus-function term. (See MIT & Elecs. for Imaging, Inc. v. Abacus
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`Software, 462 F.3d 1344, 1354 (Fed. Cir. 2006).)
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` Here, the modifier “needle protective” does not impart any structure to the
`
`term “device.” The phrase “needle protective device” is not defined in any
`
`technical dictionaries or engineering handbooks, nor is it “used in common
`
`parlance or by persons of skill in the pertinent art to designate structure.”
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`(Ex.1002, Decl. ¶¶41-50.) Thus, a POSA would not understand the term “needle
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`protective device” to define any particular structure or class of structures at the
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`time of the claimed invention. (Id. ¶¶41-50; Micron Tech., Inc. v. Innovative
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`Memory Sys., Inc., 2016 WL 5027747, IPR2016-00324, Decision Denying
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`Institution at *5 (finding “error correction module” is governed by §112 ¶6 when
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`nothing in the specification or claims indicated that a skilled artisan would
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`understand the term as a name for structure).
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`The term “needle protective device” is therefore a means-plus-function term.
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`The function, which is recited in the claims, is “to prevent unintended needle
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`sticks.” (Ex.1002, Decl. ¶¶41-50.)
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`In accordance with 37 C.F.R. § 42.104(b)(3), the structure identified in the
`
`specification to perform the function is a spring clip as more completely described
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`at ’735 patent, Figs. 1-2, 4, 5, 7a 7d, 8, 9a, 10 and cols. 2:31, 2:33-41, 3:15-27,
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`3:34-38, 3:67-4:7, 4:39-53, and structural equivalents thereof.
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`VIII. Ground I: The Challenged Claims Are Obvious over Woehr ’108 in
`view of Tauschinski, and further in view of Arnett.
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`The Challenged Claims are obvious over U.S. Patent No. 6,117,108 to
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`Woehr et al., “Spring Clip Safety IV Catheter,” filed June 12, 1998, issued
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`September 12, 2000 (“Woehr ’108) (Ex.1003), in view of U.S. Patent No.
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`4,387,879 to Tauschinski, “Self-Sealing Connector for Use with Plastic Cannulas
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`and Vessel Catheters,” filed July 16, 1981, issued June 14, 1983 (“Tauschinski”)
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`(Ex.1004), and further in view of U.S. Patent No. 5,817,069 to Arnett, “Valve
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`Assembly,” filed February 28, 1996, issued October 6, 1998 (“Arnett”) (Ex.1005).
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`(Ex.1002, Decl. ¶¶1-2, 5-6, 16-27, 51-56, 66, 67-113.) Woehr ’108, Tauschinski,
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`and Arnett qualify as prior art to the ‘735 patent under 35 U.S.C. §102(b), and are
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`cited on the face of the patent.
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`Woehr ’108 discloses a safety IV catheter with the same spring clip shown
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`in the ’735 patent to prevent needle sticks. Tauschinski describes a well-known
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`valve and valve actuator that are used with catheters to prevent the emergence of
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`blood. Arnett also discloses a valve and actuator assembly that can be used with a
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`catheter and a needle to prevent leakage, where the actuator has gaps in the second
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`actuator end to create a fluid passageway as well as a central passageway.
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`(Ex.1002, Decl. ¶¶5-6, 67-113.)
`
`During prosecution of U.S. Patent No. 7,736,339, to which the ’735 patent
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`claims priority, the examiner discussed Woehr ’108 and Tauschinski, but did not
`
`address them in combination. Later, during prosecution of U.S. Patent No.
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`8,328,762 (“’762 patent”), to which this patent also claims priority, the applicant
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`again argued that a prior art device with a valve and a valve actuator (as disclosed
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`in U.S. Patent No. 4,917,668 to Haindl) could not be modified to accommodate a
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`needle guard (as disclosed in Woehr ‘108) because “there would be no room to
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`accommodate the needle guard in a ready position” and making an accommodation
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`of this nature would necessitate that “the catheter hub. . .be made longer” thus
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`positioning “the sliding member. . .too far distally for a male Luer tip made to
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`industry standard size to actuate the sliding member.” (Ex.1010, Nov. 4, 2011
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`Office Action Response at 10.) The Ground presents a new combination of
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`references that has not previously been considered, and it provides additional
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`evidence that was not before the examiner, including the testimony of Jack Griffis
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`(Ex.1002, Decl. ¶74) and testimony by Patent Owner’s own expert that there were
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`no design concerns about combining Introcan Safety, which is the embodiment of
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`Woehr ’108 (Ex.1003) and Tauschinski (Ex.1004).
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`A.
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`Independent Claim 1
`1.
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`Element 1p. “A catheter insertion device comprising:”
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`To the extent this preamble is limiting, Woehr ’108 discloses a catheter
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`insertion device (element 10). (Ex.1003, Woehr ’108 at 2:25-26 (“It is accordingly
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`an object of the present invention to provide a safety IV catheter. . . .”), 3:26-28
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`(“FIGS. 1A and 1B are views in partial cross-section of a safety IV catheter in
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`accordance with a first embodiment of the invention. . . .”), Fig. 10A (shown
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`below); see also id. at 1:14-18, 4:8-18, 4:36-42, Figs. 1A-7D; Ex.1002, Decl. ¶67.)
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`2.
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`Element 1a. “a catheter hub…;”
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`Woehr ’108 discloses a catheter hub (element 26) comprising an interior
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`cavity, an opening at a proximal end, and a catheter tube (element 24) attached
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`thereto and extending from a distal end (element 28). (See, Ex.1003, Woehr ’108
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`at 4:13-27 (“As is also conventional, the needle 16 is received within a hollow
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`– 11 –
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`tubular catheter 24, the proximal end of which is concentrically affixed within the
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`distal end of a catheter hub 26 having a distal section 28 and a contiguous, larger
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`diameter proximal section 30.”), Fig. 10A (annotated below); see also id. at Figs.
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`1A, 1C, 2A, 3A, 4A, 5A, 6A, 7A-7E; 3:26-28, 4:8-34; Ex.1002, Decl. ¶68.)
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`3.
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`Element 1b. “a needle…;”
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`Woehr ’108 discloses a needle (element 16) having a needle shaft defining a
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`needle axis projecting distally of an end of a needle hub (element 12), said needle
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`(element 16) projecting through the catheter tube (element 24) and comprising a
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`needle tip (element 18). (See, Ex.1003, Woehr ’108 at 4:8-18, Figs. 1A, 10A
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`(annotated below); see also id. at Figs. 1-10, 4:35-42; Ex. 1002, Decl. ¶¶69-70.)
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`Woehr ’108 describes: “The safety IV catheter of the invention, generally
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`designated 10, in the embodiment illustrated in FIGS. 1A and 1B, includes a
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`needle hub 12 that includes an axial opening 14 which securely receives the
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`proximal end of a needle 16 having a sharpened tip 18. . . . As is also conventional,
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`the needle 16 is received within a hollow tubular catheter 24, the proximal end of
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`– 12 –
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`which is concentrically affixed within the distal end of a catheter hub 26. . . .”
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`U.S. Patent No. 8,333,735
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`(Ex.1003, Woehr ’108 at 4:8-18.)
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`The same elements are used to describe the needle, needle tip, catheter tube, and
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`needle hub in Fig. 10A. (Ex.1002, Decl. ¶¶69-70.)
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`4.
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`Element 1c. “a valve…;”
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`Woehr in view of Tauschinski renders obvious “a valve configured to
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`obstruct fluid flow comprising a wall surface comprising a slit positioned inside
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`the interior cavity of the catheter hub; said valve remaining inside the interior
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`cavity when the needle is removed from the catheter tube and the catheter hub.”
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`– 13 –
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`U.S. Patent No. 8,333,735
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`Tauschinski discloses a valve (element 3) configured to obstruct fluid flow
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`through the catheter hub (element 1) comprising a wall surface comprising a slit
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`(element 8) positioned inside the interior cavity of the catheter hub (element 1);
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`said valve (element 3) remaining inside the interior cavity when the needle is
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`removed from the catheter tube (element 4) and the catheter hub (element 1). See,
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`Ex.1004, Tauschinski at 2:7-19, stating:
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`[I]t is an object of the present invention to provide a connector which
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`is of the kind mentioned first hereinbefore and through which a metal
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`cannula or a vessel catheter can be pushed without obstruction but
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`which will close automatically as soon as the metal cannula or the
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`catheter or the cone fitting of a supply hose has been pulled from such
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`connector. The connector is intended to close as the metal cannula, the
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`vessel catheter or the cone fitting of the supply hose are pulled out of
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`the fitting or inadvertently fall from the same, and the closed
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`connector is intended to prevent an emergence of blood or an ingress
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`of air through the fitting.”
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`Tauschinski also discloses a slit at 2:26-31: “A metal cannula or a catheter
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`hose can be inserted through the central slit of the rubber-elastic, plane disc
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`of the connector according to the invention, and when the cannula or hose
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`– 14 –
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`has been pulled out the slit is tightly closed to seal the passage, owing to the
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`U.S. Patent No. 8,333,735
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`elasticity of the disc.” (See also id. at Fig. 2 (annotated below), Fig. 3, 2:7-
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`37, 3:14-19, 3:20-32; Ex.1002, Decl. ¶¶71-73.)
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`A POSA would have been motivated to modify Woehr ’108 based on the
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`teaching in Tauschinski that the valve prevents the emergence of blood or ingress
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`of air. One of the goals of the Woehr ’108 device is to have a protective needle
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`guard “automatically snap[] into a retracted position in which it blocks access to
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`the distal needle tip” thereby preventing “accidental contact by the health care
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`practitioner with the needle tip.” A POSA would have found it obvious to improve
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`Woehr ’108 by adding protective elements, such as a valve to prevent the
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`emergence of blood, based on the known technique disclosed in Tauschinski to
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`– 15 –
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`improve a similar catheter insertion device. (Ex.1002, Decl. ¶¶71-73.) As Patent
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`U.S. Patent No. 8,333,735
`Petition for Inter Partes Review
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`Owner’s expert, Dr. Haindl, admitted in another proceeding, he had no design
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`concern regarding the combination of the Braun Introcan Safety with the Fresenius
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`type valve.1 (Ex.1011, Australian Tr. at 587:5-11.) For at least these reasons a
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`POSA would have recognized a reason to combine the valve with the spring clip
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`safety catheter, and the combination is merely the combination of known elements
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`that would have been expected to maintain their respective functions after they
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`have been combined.
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`5.
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`Element 1d. “a valve actuating element…;”
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`The combination of Woehr ’108, Tauschinski and Arnett renders obvious “a
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`valve actuating element slidingly disposed in the catheter hub configured to actuate
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`the valve, the valve actuating element comprising a nose section having a tapered
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`end for pushing the valve to open the slit of the valve and at least two plunger
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`elements extending proximally of the nose section and having a gap therebetween
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`1 Dr. Haindl explains that he is “of the view that the Fresenius valve seems to be
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`based on the Tauschinski patent.” (Id. at 517:11-12.) The Tauschinski patent in
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`the Australian proceeding is the same as cited here. (Id. at 146:28-35.) Further,
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`B.Braun lists the Woehr ’108 as a patent covering the Introcan Safety IV Catheter.
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`(Ex. 1012, B.Braun Brochure at 6.)
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`to permit fluid flow to flow the