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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
`
`
`Filed on behalf of Becton, Dickinson and Company
`
`By: Heather M. Petruzzi, Reg. No. 71,270 (Lead Counsel)
` Wilmer Cutler Pickering Hale and Dorr LLP
`
` 1875 Pennsylvania Avenue, NW
`
` Washington, DC 20006
`
`Tel: (202) 663-6000
`
`Email: Heather.Petruzzi@wilmerhale.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`BECTON, DICKINSON AND COMPANY,
`Petitioner,
`
`v.
`
`B.BRAUN MELSUNGEN AG,
`Patent Owner of
`U.S. Patent No. 8,337,463 to Woehr et al.
`
`IPR Trial No. IPR2017-01585
`
`
`PETITION FOR INTER PARTES REVIEW
`OF CLAIMS 1, 2, 10, 12, 25, 28 OF U.S. PATENT NO. 8,337,463
`UNDER 35 U.S.C. §312 AND 37 C.F.R. §42.104
`
`
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`U.S. Patent No. 8,337,463
`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’463 Patent ............................................................................. 3 
`A. 
`State of the Art ...................................................................................... 3 
`B. 
`Brief Description of the ’463 Patent in View of the State of the Art .... 4 
`VI.  POSA ............................................................................................................... 6 
`VII.  Claim Construction .......................................................................................... 7 
`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. ................................................... 10 
`A. 
`Independent Claim 1 ........................................................................... 13 
`1. 
`Element 1p. “A catheter insertion device comprising:” . 13 
`2. 
`Element 1a. “a catheter hub…;” ..................................... 13 
`3. 
`Element 1b. “a needle…;” .............................................. 14 
`4. 
`Element 1c. “a valve…;” ................................................ 16 
`5. 
`Element 1d. “a valve actuating element…;” .................. 20 
`6. 
`Element 1e. “a needle protective device….” .................. 25 
`Dependent Claim 2 .............................................................................. 28 
`Independent Claim 10 ......................................................................... 28 
`1. 
`Element 10p. “A catheter insertion device comprising:”
` ........................................................................................ 28 
`
`B. 
`C. 
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`2. 
`Element 10a. “a first hub…;” ......................................... 29 
`Element 10b. “a needle…;” ............................................ 29 
`3. 
`Element 10c. “a valve…;” .............................................. 29 
`4. 
`Element 10d. “a valve actuating element…;” ................ 30 
`5. 
`Element 10e. “a needle protective device….” ................ 32 
`6. 
`D.  Dependent Claim 12 ............................................................................ 33 
`E. 
`Independent Claim 25 ......................................................................... 34 
`1. 
`Element 25p. “A catheter insertion device comprising:”
` ........................................................................................ 34 
`Element 25a. “a catheter hub…;” ................................... 34 
`2. 
`Element 25b. “a needle…;” ............................................ 35 
`3. 
`Element 25c. “a valve…;” .............................................. 36 
`4. 
`Element 25d. “a valve actuating element…;” ................ 36 
`5. 
`Element 25e. “a needle protective device….” ................ 38 
`6. 
`Dependent Claim 28 ............................................................................ 39 
`F. 
`IX.  Ground II: The Challenged Claims Are Obvious over Van Heugten in view
`of Arnett. ........................................................................................................ 40 
`A. 
`Independent Claim 1 ........................................................................... 41 
`1. 
`Element 1p. “A catheter insertion device comprising:” . 41 
`2. 
`Element 1a. “a catheter hub…;” ..................................... 42 
`3. 
`Element 1b. “a needle…;” .............................................. 42 
`4. 
`Element 1c. “a valve…;” ................................................ 43 
`5. 
`Element 1d. “a valve actuating element…;” .................. 47 
`6. 
`Element 1e. “a needle protective device….” .................. 49 
`Dependent Claim 2 .............................................................................. 50 
`Independent Claim 10 ......................................................................... 51 
`1. 
`Element 10p. “A catheter insertion device comprising:”
` ........................................................................................ 51 
`Element 10a. “a first hub…;” ......................................... 51 
`Element 10b. “a needle…;” ............................................ 51 
`Element 10c. “a valve…;” .............................................. 51 
`
`2. 
`3. 
`4. 
`
`B. 
`C. 
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`5. 
`Element 10d. “a valve actuating element…;” ................ 53 
`Element 10e. “a needle protective device….” ................ 55 
`6. 
`D.  Dependent Claim 12 ............................................................................ 57 
`E. 
`Independent Claim 25 ......................................................................... 57 
`1. 
`Element 25p. “A catheter insertion device comprising:”
` ........................................................................................ 57 
`Element 25a. “a catheter hub…;” ................................... 57 
`2. 
`Element 25b. “a needle…;” ............................................ 59 
`3. 
`Element 25c. “a valve…;” .............................................. 59 
`4. 
`Element 25d. “a valve actuating element…;” ................ 59 
`5. 
`Element 25e. “a needle protective device….” ................ 61 
`6. 
`Dependent Claim 28 ............................................................................ 62 
`F. 
`Secondary Considerations of Nonobviousness Do Not Negate the Above
`Obviousness Grounds. ................................................................................... 63 
`XI.  Conclusion ..................................................................................................... 63 
`
`X. 
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`– iv –
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
`
`Table of Authorities
`
` Page(s)
`
`Cases
`Adlens USA, Inc. v. Superfocus Holdings LLC,
`2016 WL 7992047 (Dec. 27, 2016) ...................................................................... 7
`Apple Inc. v. Immersion Corp.,
`2017 WL 376909 (Jan. 11, 2017) ......................................................................... 7
`In re Donaldson Co.,
`16 F.3d 1189 (Fed. Cir. 1994) ............................................................................. 8
`Lighting World, Inc. v. Birchwood Lighting, Inc.,
`382 F.3d 1354 (Fed. Cir. 2004) ............................................................................ 9
`Micron Tech., Inc. v. Innovative Memory Sys., Inc.,
`2016 WL 5027747 (June 13, 2016) ...................................................................... 9
`MIT & Elecs. for Imaging, Inc. v. Abacus Software,
`462 F.3d 1344 (Fed. Cir. 2006) ............................................................................ 8
`Verizon Servs. Corp. v. AIP Acquisitions LLC,
`2015 WL 9899021 (Oct. 15, 2015) ....................................................................... 7
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) ....................................................................... 7, 8
`Statutes
`35 U.S.C. § 102 .................................................................................................. 11, 40
`35 U.S.C. § 103 ...................................................................................................... 2, 3
`35 U.S.C. § 112 .......................................................................................... 7, 8, 10, 40
`Rules
`Rule 42.104 .......................................................................................................... 2, 12
`Rule 42.22 .................................................................................................................. 2
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`Regulations
`37 C.F.R. § 42.100 ..................................................................................................... 7
`37 C.F.R. § 42.104 ................................................................................................... 10
`56 Fed. Reg. 64004 (Dec. 6, 1991) ............................................................................ 3
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`– vi –
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`I.
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`Introduction
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`
`
`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`Petitioner requests institution of an inter partes review to cancel claims 1, 2,
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`10, 12, 25, and 28 (“Challenged Claims”) of U.S. Patent No. 8,337,463 (“the ’463
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`patent”). For the reasons set forth below, there is a reasonable likelihood that the
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`Challenged Claims are unpatentable as obvious.
`
`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; 8,333,735;
`
`8,540,728; 9,149,626; 8,597,249; 8,460,247; and 9,370,641.
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`C. Counsel
`
`Lead Counsel:
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`Heather M. Petruzzi (Reg. No. 71,270)
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`Back-up Counsel: 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. 8,337,463
`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, 2, 10, 12, 25, and 28 of the ’463 patent as unpatentable
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`under 35 U.S.C. §103 based on the following grounds.
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`U.S. Patent No. 8,337,463
`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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`II
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`103
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`103
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`1, 2, 10,
`12, 25,
`28
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`1, 2, 10,
`12, 25,
`28
`
`B. Relief Requested
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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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`Petitioner requests that the Board cancel the Challenged Claims because
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`they are unpatentable under 35 U.S.C. §103.
`
`V. Overview of the’463 Patent
`A.
`
`State of the Art
`
`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 and thereby injured or infected by blood borne pathogens. (Ex. 1002,
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`Declaration of Jack Griffis (“Griffis Decl.” or “Decl.) ¶¶ 31-33.) In addition to
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`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. ¶ 34.)
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`The 1991 OSHA Bloodborne Pathogens Standard, 56 Fed. Reg. 64004 at 64114
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`(Dec. 6, 1991) identified “self-sheathing needles” as an engineering control to
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`reduce employee exposure to hazardous pathogens. (Ex. 1015, OSHA Standard;
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`Ex. 1002, Griffis Decl. ¶ 34.) In 2000, the Needlestick Safety and Prevention Act
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`– 3 –
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`recognized that “the use of safer medical devices, such as needleless systems and
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`sharps with engineered sharps injury protections, when they are part of an overall
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`bloodborne pathogens risk-reduction program, can be extremely effective in
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`reducing accidental sharps injuries.” (Ex., 1016, Needlestick Safety and
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`Prevention Act, Pub. L. No. 106-430, 114 Stat. 1901, 1902 (2000)). The 2000 Act
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`also updated the bloodborne pathogens standard to include the term “Sharps with
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`Engineered Sharps Injury Protections” to be “a nonneedle sharp or a needle device
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`used for withdrawing body fluids, accessing a vein or artery, or administering
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`medications or other fluids, with a built-in safety feature or mechanism that
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`effectively reduces the risk of an exposure incident.” (Id.; see also Ex. 1002,
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`Griffis Decl. ¶ 34.)
`
`It was also recognized, for example in U.S. Patent No. 5,053,014 (“Van
`
`Heugten”), that during use of an I.V. catheter assembly it is desirable to minimize
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`“any blood leakage from the assembly so as to reduce the risk of transmitting
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`blood-borne diseases to medical personnel.” (Ex. 1006, Van Heugten at 1:15-18.)
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`B.
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`Brief Description of the ’463 Patent in View of the State of the Art
`
`The ’463 patent was filed on March 20, 2012, and claims priority to a
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`German patent application filed on July 4, 2002. The ’463 patent describes an
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`over-the-needle catheter insertion device. Figure 1, reproduced below,
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`– 4 –
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`demonstrates the various claimed features of the catheter assembly, as annotated
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`by Mr. Griffis is shown below:
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`
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`(Ex. 1002, Griffis Decl. ¶ 35.)
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`The device claimed in the ’463 patent is composed of various, standard
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`features in catheter assemblies. The ’463 patent acknowledges that catheter
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`assemblies including a catheter hub, a needle guard element, and a hollow needle
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`that engages with a needle guard element were known. (Ex. 1001, ‘463 patent at
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`1:22-30; Ex. 1002, Griffis Decl. ¶ 36).
`
`The ’463 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
`
`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. (Id. at 1:39-
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`48). These “objectives” were also well known in the art. (Ex. 1002, Griffis Decl. ¶
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`37; Ex. 1006, Van Heugten at claim 1.)
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`– 5 –
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`The ’463 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
`
`force pushes a valve actuating element in a distal direction. (Ex. 1001, ’463 patent
`
`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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`Griffis Decl. ¶ 38.) In order to cover the needle tip to prevent injury, the ’463
`
`patent discloses a spring clip that closes around the needle tip as it is withdrawn
`
`from the catheter hub. (Ex. 1001, ’463 patent at 2:33-41.) The same spring clip
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`disclosed in the ’463 patent was also known as of 2002. (Ex. 1002, Griffis Decl. ¶
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`39.) Further, catheter insertion devices with the combination of blood control and
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`needle protection were well known by 2002. (Id. at ¶ 40)
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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
`
`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, Griffis Decl. ¶ 30.)
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`– 6 –
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`VII. Claim Construction
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`Generally in an inter partes review, the Board construes claim terms in an
`
`unexpired patent according to their broadest reasonable construction in light of the
`
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b).
`
`A.
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`“needle protective device”
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`A claim term defined by the performance of a function that does not recite
`
`sufficient structure for performing the function is construed under 35 U.S.C. § 112,
`
`¶ 6. (Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (en
`
`banc).) In Williamson, the Federal Circuit held that there was no “heightened
`
`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,
`
`“[where] the claim term fails to ‘recite sufficiently definite structure’ or else recites
`
`‘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); Verizon Servs.
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`Corp. v. AIP Acquisitions LLC, 2015 WL 9899021, IPR2015-01106, Paper 10
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`(Institution of Inter Partes Review) at *10 (Oct. 15, 2015); Apple Inc. v. Immersion
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`Corp., 2017 WL 376909, IPR2016-01372, Paper 7 (Institution of Inter Partes
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`Review) at *6 (Jan. 11, 2017).
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`Once it is determined that a claim term is a means-plus-function term, a two-
`
`step analysis under § 112, ¶ 6 applies. Williamson, 792 F.3d at 1351-52; In re
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`Donaldson Co., 16 F.3d 1189, 1195 (Fed. Cir. 1994) (en banc). The first step
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`requires identifying the claimed function. Id. The second step is identifying 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, 2, 10, 12, 25, and 28 recite “a catheter insertion device comprising
`
`. . . a needle protective device . . . to prevent unintended needle sticks.” The use of
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`the word “device” in the claims does not impart any structure and is tantamount to
`
`using the word “means.” Williamson, 792 F.3d at 1350. The term “needle
`
`protective device” is not used, nor is it defined, in the specification of the ’463
`
`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. (“The prefix ‘distributed learning
`
`control’ does not impart structure into the term ‘module.’”) If the modifier has no
`
`dictionary definition and no generally understood structural meaning in the art,
`
`then the term is a means-plus-function term. (See MIT & Elecs. for Imaging, Inc.
`
`v. Abacus Software, 462 F.3d 1344, 1354 (Fed. Cir. 2006). (“[T]he term ‘colorant
`
`selection,’ which modifies ‘mechanism’ here, is not defined in the specification
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`and has no dictionary definition, and there is no suggestion that it has a generally
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`understood meaning in the art.”).)
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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.” (Ex.
`
`1002, Griffis Decl. ¶¶ 41-45); Lighting World, Inc. v. Birchwood Lighting, Inc.,
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`382 F.3d 1354, 1359-60 (Fed. Cir. 2004). As Mr. Griffis explains, devices and
`
`mechanisms that prevent needle sticks are described by a wide variety of phrases,
`
`such as needle shield, safety mechanism, safety feature, protective device, and
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`needle stick prevention device, but these functional phrases do not convey any
`
`structural meaning to those in the art. (Ex. 1002, Griffis Decl. ¶ 46.) As Mr.
`
`Griffis also explains, at the time of the alleged invention, different safety devices
`
`were being developed at a fast pace and new structures and methods were being
`
`continually introduced in the art. (Id. at ¶ 47). Thus, a POSA would not
`
`understand the term “needle protective device” to define any particular structure or
`
`class of structures at the time of the claimed invention. (Id.; see Micron Tech., Inc.
`
`v. Innovative Memory Sys., Inc., 2016 WL 5027747; IPR2016-00324, Decision
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`Denying Institution at *5 (June 13, 2016) (finding “error correction module” is
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`governed by § 112 ¶ 6 when nothing in the specification or claims indicated that a
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`skilled artisan would 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
`
`sticks.” (Ex. 1002, Griffis Decl. ¶ 49.)
`
`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
`
`in the ’463 patent at FIGS. 1-2, 4, 5, 7a, 7d, 8, 9a, 10, and cols. 2:29, 2:31-39,
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`3:13-25, 3:32-36, 3:65-4:5, 4:35-49, and structural equivalents thereof. (Ex. 1002,
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`Griffis Decl. ¶ 50.)
`
`VIII. Ground I: The Challenged Claims Are Obvious over Woehr ’108 in
`view of Tauschinski, and further in view of Arnett.
`
`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).
`
`(Ex. 1002, Griffis Decl. ¶¶ 61-106.) Woehr ’108, Tauschinski, and Arnett qualify
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`– 10 –
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`as prior art to the ‘463 patent under 35 U.S.C. §102(b), and are cited on the face of
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`U.S. Patent No. 8,337,463
`Petition for Inter Partes Review
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`the patent.
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`Woehr ’108 discloses a safety IV catheter with the same spring clip shown
`
`in the ’463 patent to prevent needle sticks. (Ex. 1002, Griffis Decl. ¶ 53.)
`
`Tauschinski describes a well-known valve and valve actuator that are used with
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`catheters to prevent the emergence of blood. (Id. at ¶ 55.) Arnett also discloses a
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`valve and actuator assembly that can be used with a catheter and a needle to
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`prevent leakage, where the actuator has gaps in the second actuator end to create a
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`fluid passageway as well as a central passageway. (Id. at ¶ 57.)
`
`During prosecution of U.S. Patent No. 7,736,339, to which the ’463 patent
`
`claims priority, the examiner discussed Woehr ’108 and Tauschinski, but did not
`
`address them in combination. Later, during prosecution of U.S. Pat. No. 8,328,762
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`(“’762 patent”), to which this patent also claims priority, the applicant again
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`argued that a prior art device with a valve and a valve actuator (as disclosed in U.S.
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`Patent No. 4,917,668 to Haindl) could not be modified to accommodate a needle
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`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. 1008, Nov. 4, 2011
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`– 11 –
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`Office Action Response at 10). This petition explains why Ground I renders the
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`challenged claims obvious.
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`The Ground presents a new combination of references that has not
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`previously been considered, and it provides additional evidence that was not before
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`the examiner, including the testimony of Jack Griffis (Ex. 1002) and testimony by
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`Patent Owner’s own expert that there were no design concerns about combining
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`Introcan Safety, which is the embodiment of Woehr ’108 (Ex. 1003), and
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`Tauschinski (Ex. 1004.)
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`The Challenged Claims recite features long known by engineers who design
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`IV catheters. (Ex. 1002, Griffis Decl. ¶ 60.) The structures in the claimed catheter
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`assembly all have known functions that perform in expected ways. (Id.) Based on
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`the prior art described below, the claim limitations perform known functions with
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`predictable results and there is no unexpected result on which to base the
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`patentability of the claims. (Id.)
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`Pursuant to Rule 42.104(b)(4)-(5), specific grounds I-II identified below and
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`discussed in the Griffis Declaration (Ex. 1002) show in detail the prior art
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`disclosures that makes the challenged claims obvious.
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`– 12 –
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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 (e.g., element 10). (See, e.g., Ex. 1003, Woehr ’108 at 2:25-26
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`(“It is accordingly an object of the present invention to provide a safety IV
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`catheter…”), 3:26-28 (“FIGS. 1A and 1B are views in partial cross-section of a
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`safety IV catheter in accordance with a first embodiment of the invention…”), Fig.
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`10A (shown below); see also id. at 1:14-18, 4:8-18, 4:36-42, Figs. 1A-7D; Ex.
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`1002, Griffis Decl. ¶ 61.
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`2.
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`Element 1a. “a catheter hub…;”
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`Woehr ’108 discloses a catheter hub (e.g., element 26) comprising an
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`interior cavity, an opening at a proximal end, and a catheter tube (e.g., element 24)
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`attached thereto and extending from a distal end (e.g., element 28). See, e.g., Ex.
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`1003, Woehr ’108 at 4:13-27 (“As is also conventional, the needle 16 is received
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`within a hollow tubular catheter 24, the proximal end of which is concentrically
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`affixed within the distal end of a catheter hub 26 having a distal section 28 and a
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`– 13 –
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`contiguous, larger diameter proximal section 30.”), FIG. 10A (annotated below);
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`see also id. at FIGS. 1A, 1C, 2A, 3A, 4A, 5A, 6A, 7A-7E; 3:26-28, 4:8-34, Ex.
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`1002, Griffis Decl. ¶ 62.
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`3.
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`Element 1b. “a needle…;”
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`Woehr ’108 discloses a needle (e.g., element 16) having a needle shaft
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`defining a needle axis projecting distally of an end of a needle hub (e.g., element
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`12), said needle (e.g., element 16) projecting through the catheter tube (e.g.,
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`element 24) and comprising a needle tip (e.g., element 18). See, e.g., Ex. 1003
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`Woehr ’108 at 4:8-18, FIG. 1A (annotated below); see also id. at Figs. 1-10, 4:35-
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`42; Ex. 1002, Griffis Decl. ¶ 63. Woehr ’108 describes, “The safety IV catheter of
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`the invention, generally designated 10, in the embodiment illustrated in FIGS. 1A
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`and 1B, includes a needle hub 12 that includes an axial opening 14 which securely
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`receives the proximal end of a needle 16 having a sharpened tip 18. . . . As is also
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`conventional, the needle 16 is received within a hollow tubular catheter 24, the
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`– 14 –
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`proximal end of which is concentrically affixed within the distal end of a catheter
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`hub 26...” (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. Thus, a POSA would understand that the same description
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`of these elements for Fig. 1A also applies to Fig. 10A. (Ex. 1002, Griffis Decl. ¶
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`64.)
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`– 15 –
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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 sized and shaped to
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`obstruct fluid flow through the catheter hub comprising a wall surface comprising
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`a slit positioned inside the interior cavity of the catheter hub and abutting a
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`shoulder in the interior cavity of the catheter hub; said valve remaining inside the
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`interior cavity when the needle is removed from the catheter tube and the catheter
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`hub.” (Ex. 1002, Griffis Decl. ¶ 65.)
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`As shown and described in connections with Figures 2 and 3, Tauschinski,
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`discloses the claimed valve (e.g., element 3), i.e., sized and shaped to obstruct fluid
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`flow through the catheter hub (e.g., element 1) comprising a wall surface
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`comprising a slit (e.g., element 8) positioned inside the interior cavity of the
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`catheter hub (e.g., element 1) and abutting a shoulder (e.g., element 7) in the
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`interior cavity of the catheter hub; said valve (e.g., element 3) remaining inside the
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`interior cavity when the needle is removed from the catheter tube (e.g., element 4)
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`and the catheter hub (e.g., element 1). (Ex. 1002, Griffis Decl. ¶ 66.) See, e.g., Ex.
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`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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`– 16 –
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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 of the
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`connector according to the invention, and when the cannula or hose has been
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`pulled out the slit is tightly closed to seal the passage, owing to the elasticity of the
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`disc.” (Ex. 1002, Griffis Decl. ¶ 66.) Tauschinski further discloses that the interior
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`cavity of the connector body 1 has a groove 7, which a POSA would understand to
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`create a shoulder in the interior cavity, and that the disc 3 is fitted into this space.
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`(Ex. 1002, Griffis Decl. ¶ 67.) (See also id. at FIG. 2 (annotated below), FIG. 3,
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`2:7-37, 3:14-19; 3:20-32)
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`– 17 –
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`(See also Ex. 10