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`
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`U.S. Patent No. 8,460,247
`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. 8,460,247 to Woehr et al.
`
`IPR Trial No. IPR2017-01588
`
`
`PETITION FOR INTER PARTES REVIEW
`OF CLAIMS 12, 13, 20, 21, 22, 23, 29 OF U.S. PATENT NO. 8,460,247
`UNDER 35 U.S.C. § 312 AND 37 C.F.R. § 42.104
`
`
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`Table of Contents
`Introduction ...................................................................................................... 1 
`I. 
`II.  Mandatory Notices ........................................................................................... 1 
`A. 
`Real Party in Interest ............................................................................. 1 
`B. 
`Related Matters ...................................................................................... 1 
`C. 
`Counsel .................................................................................................. 2 
`D. 
`Service Information ............................................................................... 2 
`III.  Certification of Grounds for Standing ............................................................. 2 
`IV.  Overview of Challenge and Relief Requested ................................................. 3 
`A.  Grounds of Challenge ............................................................................ 3 
`B. 
`Relief Requested .................................................................................... 4 
`V.  Overview of the State of the Art and the ’247 Patent ..................................... 4 
`A. 
`The State of the Art ............................................................................... 4 
`B. 
`Brief Description of the ’247 Patent ..................................................... 5 
`C. 
`Summary of the ’247 Patent’s Prosecution History .............................. 9 
`VI.  Person of Ordinary Skill in the Art ................................................................ 10 
`VII.  Claim Construction ........................................................................................ 11 
`A. 
`“needle protective device” .................................................................. 11 
`VIII.  Ground I: The Challenged Claims Are Obvious over Woehr in view of
`Callaway. ....................................................................................................... 16 
`A. 
`Independent Claim 12 is Obvious over Woehr in view of Callaway . 17 
`1. 
`“A safety catheter assembly comprising” ....................... 17 
`2. 
`Element 12a. “a first hub…” .......................................... 18 
`3. 
`Element 12b. “a needle having a needle shaft…” ......... 19 
`4. 
`Element 12c. “a valve . . .” ............................................. 20 
`5. 
`Element 12d. “a valve actuating element . . .” .............. 21 
`6. 
`Element 12e. “a needle protective device . . . ” .............. 23 
`7. 
`Element 12f. “wherein an arm extends distally of a third
`hub . . . ” .......................................................................... 25 
`Element 12g. “wherein a portion . . .” ........................... 29 
`
`8. 
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`B. 
`Dependent Claim 13 is Obvious over Woehr in view of Callaway .... 29 
`Dependent Claim 20 is Obvious over Woehr in view of Callaway .... 31 
`C. 
`D.  Dependent Claim 21 is Obvious over Woehr in view of Callaway .... 31 
`E. 
`Dependent Claim 22 is Obvious over Woehr in view of Callaway .... 32 
`F. 
`Independent Claim 23 is Obvious over Woehr in view of Callaway . 33 
`1. 
`“A safety catheter assembly comprising” ....................... 33 
`2. 
`Element 23a. “a catheter hub . . .” ................................. 33 
`3. 
`Element 23b. “a needle . . .” .......................................... 34 
`4. 
`Element 23c. “a valve . . .” ............................................ 34 
`5. 
`Element 23d. “a valve actuating element . . .” .............. 35 
`6. 
`Element 23e. “a needle protective device . . .” .............. 37 
`7. 
`Element 23f. “wherein an arm . . .” ............................... 37 
`G.  Dependent Claim 29 is Obvious over Woehr in view of Callaway .... 38 
`IX.  Ground II: The Challenged Claims Are Obvious over Woehr in view of
`Villa. .............................................................................................................. 38 
`A. 
`Independent Claim 12 is Obvious over Woehr in view of Villa ......... 39 
`1. 
`“A safety catheter assembly comprising” ....................... 39 
`2. 
`Element 12a. “a first hub…” .......................................... 39 
`3. 
`Element 12b. “a needle having a needle shaft…” ......... 39 
`4. 
`Element 12c. “a valve . . .” ............................................. 40 
`5. 
`Element 12d. “a valve actuating element . . .” .............. 40 
`6. 
`Element 12e. “a needle protective device . . . ” .............. 40 
`7. 
`Element 12f. “wherein an arm extends distally of a third
`hub . . . ” .......................................................................... 40 
`Element 12g. “wherein a portion . . .” ........................... 44 
`8. 
`Dependent Claim 13 is Obvious over Woehr in view of Villa ........... 45 
`B. 
`Dependent Claim 20 is Obvious over Woehr in view of Villa ........... 46 
`C. 
`D.  Dependent Claim 21 is Obvious over Woehr in view of Villa ........... 46 
`E. 
`Dependent Claim 22 is Obvious over Woehr in view of Villa ........... 46 
`F. 
`Independent Claim 23 is Obvious over Woehr in view of Villa ......... 46 
`
`– iii –
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`1. 
`“A safety catheter assembly comprising” ....................... 46 
`Element 23a. “a catheter hub…” .................................... 47 
`2. 
`Element 23b. “a needle . . .” .......................................... 47 
`3. 
`Element 23c. “a valve . . .” ............................................ 47 
`4. 
`Element 23d. “a valve actuating element . . .” .............. 47 
`5. 
`Element 23e. “a needle protective device . . .” .............. 47 
`6. 
`Element 23f. “wherein an arm . . .” ............................... 47 
`7. 
`G.  Dependent Claim 29 is Obvious over Woehr in view of Villa ........... 49 
`X.  Ground III: The Challenged Claims Are Obvious over Woehr in view of
`Callaway and further in view of Sutton ......................................................... 49 
`A. 
`Independent Claim 12 is Obvious over Woehr in view of Callaway
`and further in view of Sutton ............................................................... 49 
`1. 
`“A safety catheter assembly comprising” ....................... 49 
`2. 
`Element 12a. “a first hub…” .......................................... 50 
`3. 
`Element 12b. “a needle having a needle shaft…” ......... 50 
`4. 
`Element 12c. “a valve . . .” ............................................. 50 
`5. 
`Element 12d. “a valve actuating element . . .” .............. 50 
`6. 
`Element 12e. “a needle protective device . . . ” .............. 50 
`7. 
`Element 12f. “wherein an arm extends distally of a third
`hub . . . ” .......................................................................... 50 
`Element 12g. “wherein a portion . . .” ........................... 54 
`8. 
`Dependent Claim 13 is Obvious over Woehr in view of Callaway and
`further in view of Sutton ..................................................................... 54 
`Dependent Claim 20 is Obvious over Woehr in view of Callaway and
`further in view of Sutton ..................................................................... 54 
`D.  Dependent Claim 21 is Obvious over Woehr in view of Callaway and
`further in view of Sutton ..................................................................... 54 
`Dependent Claim 22 is Obvious over Woehr in view of Callaway and
`further in view of Sutton ..................................................................... 54 
`Independent Claim 23 is Obvious over Woehr in view of Callaway
`and further in view of Sutton ............................................................... 55 
`1. 
`“A safety catheter assembly comprising” ....................... 55 
`
`B. 
`
`C. 
`
`E. 
`
`F. 
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`2. 
`Element 23a. “a catheter hub…” .................................... 55 
`Element 23b. “a needle . . .” .......................................... 55 
`3. 
`Element 23c. “a valve . . .” ............................................ 55 
`4. 
`Element 23d. “a valve actuating element . . .” .............. 55 
`5. 
`Element 23e. “a needle protective device . . .” .............. 55 
`6. 
`Element 23f. “wherein an arm . . .” ............................... 56 
`7. 
`G.  Dependent Claim 29 is Obvious over Woehr in view of Callaway and
`further in view of Sutton ..................................................................... 56 
`XI.  Ground IV: The Challenged Claims Are Obvious over Woehr in view of
`Villa and further in view of Sutton ................................................................ 57 
`A. 
`Independent Claim 12 is Obvious over Woehr in view of Villa and
`further in view of Sutton ..................................................................... 57 
`1. 
`“A safety catheter assembly comprising” ....................... 57 
`2. 
`Element 12a. “a first hub…” .......................................... 57 
`3. 
`Element 12b. “a needle having a needle shaft…” ......... 57 
`4. 
`Element 12c. “a valve . . .” ............................................. 57 
`5. 
`Element 12d. “a valve actuating element . . .” .............. 57 
`6. 
`Element 12e. “a needle protective device . . . ” .............. 58 
`7. 
`Element 12f. “wherein an arm extends distally of a third
`hub . . . ” .......................................................................... 58 
`Element 12g. “wherein a portion . . .” ........................... 60 
`8. 
`Dependent Claim 13 is Obvious over Woehr in view of Villa and
`further in view of Sutton ..................................................................... 60 
`Dependent Claim 20 is Obvious over Woehr in view of Villa and
`further in view of Sutton ..................................................................... 60 
`D.  Dependent Claim 21 is Obvious over Woehr in view of Villa and
`further in view of Sutton ..................................................................... 60 
`Dependent Claim 22 is Obvious over Woehr in view of Villa and
`further in view of Sutton ..................................................................... 61 
`Independent Claim 23 is Obvious over Woehr in view of Villa and
`further in view of Sutton ..................................................................... 61 
`1. 
`“A safety catheter assembly comprising” ....................... 61 
`
`B. 
`
`C. 
`
`E. 
`
`F. 
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`– v –
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`2. 
`Element 23a. “a catheter hub…” .................................... 61 
`Element 23b. “a needle . . .” .......................................... 61 
`3. 
`Element 23c. “a valve . . .” ............................................ 61 
`4. 
`Element 23d. “a valve actuating element . . .” .............. 61 
`5. 
`Element 23e. “a needle protective device . . .” .............. 62 
`6. 
`Element 23f. “wherein an arm . . .” ............................... 62 
`7. 
`G.  Dependent Claim 29 is Obvious over Woehr in view of Villa and
`further in view of Sutton ..................................................................... 63 
`XII.  Ground V: Challenged Dependent Claim 22 Is Obvious over Woehr in view
`of Callaway and further in view of Nakajima. .............................................. 63 
`XIII.  Ground VI: Challenged Dependent Claim 22 Is Obvious over Woehr in view
`of Villa and further in view of Nakajima ...................................................... 66 
`XIV.  Ground VII: Challenged Dependent Claim 22 Is Obvious over Woehr in
`view of Callaway and further in view of Sutton and further in view of
`Nakajima ........................................................................................................ 66 
`XV.  Ground VIII: Challenged Dependent Claim 22 Is Obvious over Woehr in
`view of Villa and further in view of Sutton and further in view of Nakajima67 
`XVI.  Secondary Considerations of Nonobviousness Do Not Negate the Above
`Obviousness Grounds. ................................................................................... 67 
`XVII. Conclusion ..................................................................................................... 68 
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`Table of Authorities
`
` Page(s)
`
`Cases
`Adlens USA, Inc. v. Superfocus Holdings LLC,
`2016 WL 7992047 (Dec. 27, 2016) .................................................................... 12
`Apple Inc. v. Immersion Corp.,
`2017 WL 376909 (Jan. 11, 2017) ....................................................................... 12
`In re Donaldson Co.,
`16 F.3d 1189 (Fed. Cir. 1994) ............................................................................ 12
`Lighting World, Inc. v. Birchwood Lighting, Inc.,
`382 F.3d 1354 (Fed. Cir. 2004) .......................................................................... 14
`Mas-Hamilton Grp. v. LaGard, Inc.,
`156 F.3d 1206 (Fed. Cir. 1998) .......................................................................... 13
`MIT & Elecs. for Imaging, Inc. v. Abacus Software,
`462 F.3d 1344 (Fed. Cir. 2006) .......................................................................... 13
`Ohio Willow Wood Co. v. Alps South, LLC,
`735 F.3d 1333 (Fed. Cir. 2013) .......................................................................... 68
`Tokai Corp. v. Easton Enters., Inc.,
`632 F.3d 1358 (Fed. Cir. 2011) .......................................................................... 67
`Verizon Servs. Corp. v. AIP Acquisitions LLC,
`2015 WL 9899021 .............................................................................................. 12
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) (en banc) .............................................. 11, 12, 13
`Willis Elec. Co., Ltd. v. Polygroup Macau Ltd. (BVI),
`IPR2017-00330 (May 25, 2017) ......................................................................... 12
`Statutes
`35 U.S.C. § 102 .................................................................................................passim
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`– vii –
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`35 U.S.C. § 103 ...................................................................................................... 3, 4
`35 U.S.C. § 112 .................................................................................................. 11, 12
`Rules
`Rule 42.104 ................................................................................................ 2, 3, 14, 17
`Rules 42.22(a)(1) ....................................................................................................... 3
`Regulations
`37 C.F.R. § 42.100 ................................................................................................... 11
`37 C.F.R. § 42.104 ................................................................................... 2, 13, 14, 17
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`– viii –
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`
`
`I.
`
`Introduction
`
`
`
`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
`
`Petitioner requests institution of an inter partes review to cancel claims 12,
`
`13, 20, 21, 22, 23, and 29 (“Challenged Claims”) of U.S. Patent No. 8,460,247
`
`(“the ’247 patent”). For the reasons set forth below, there is a reasonable
`
`likelihood that the Challenged Claims are unpatentable as obvious over (1) Woehr
`
`in view of Callaway (Ground I), (2) Woehr in view of Villa (Ground II), (3) Woehr
`
`in view of Callaway and further in view of Sutton (Ground III), (4) Woehr in view
`
`of Villa and further in view of Sutton (Ground IV), (5) Woehr in view of Callaway
`
`and further in view of Nakajima (Ground V), (6) Woehr in view of Villa and
`
`further in view of Nakajima (Ground VI), (7) Woehr in view of Callaway and
`
`further in view of Sutton and further in view of Nakajima (Ground VII), and
`
`(8) Woehr in view of Villa and further in view of Sutton and further in view of
`
`Nakajima (Ground VIII).
`
`II. Mandatory Notices
`A. Real Parties in Interest
`
`Becton, Dickinson and Company and Becton Dickinson Infusion Therapy
`
`Systems, Inc. are real-parties-in-interest.
`
`B. Related Matters
`
`The Challenged Claims have been asserted against Petitioners in B. Braun
`
`Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D.
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`– 1 –
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`Del.). Additionally, IPRs are being filed on U.S. Patent Nos. 8,328,762;
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`
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`8,333,735; 8,337,463; 8,540,728; 9,149,626; 8,597,249; and 9,370,641.
`
`C. Counsel
`
`Lead Counsel:
`
`Heather M. Petruzzi (Reg. No. 71,270)
`
`Back-up Counsel:
`
`Natalie Pous (Reg. No. 62,191)
`
`
`
`
`
`David Cavanaugh (Reg. No. 36,476)
`
`
`
`D.
`
`Service Information
`
`Email:
`
`Heather.Petruzzi@wilmerhale.com;
`
`Natalie.Pous@wilmerhale.com;
`
`David.Cavanaugh@wilmerhale.com
`
`Post & Hand Delivery: Wilmer Cutler Pickering Hale and Dorr LLP
`
`1875 Pennsylvania Avenue NW, Washington, DC 20006
`
`Tel: (202) 663-6000, Facsimile: (202) 663-6363
`
`Petitioners agree to accept service by email.
`
`III. Certification of Grounds for Standing
`
`Petitioner certifies pursuant to Rule 42.104(a) that the patent for which
`
`review is sought is available for inter partes review and that Petitioner is not
`
`barred or estopped from requesting an inter partes review on the grounds identified
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`– 2 –
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`in this Petition.
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`IV. Overview of Challenge and Relief Requested
`A. Grounds of Challenge
`
`Under Rules 42.22(a)(1) and 42.104(b)(1)-(2), Petitioners request
`
`cancellation of claims 12, 13, 20, 21, 22, 23, 29 of the ’247 patent as unpatentable
`
`under 35 U.S.C. §103 based on the following grounds.
`
`Ground 35 U.S.C. § Claims
`
`References
`
`I
`
`II
`
`III
`
`IV
`
`103
`
`103
`
`103
`
`103
`
`V
`
`103
`
`12, 13,
`20, 21,
`22, 23,
`29
`12, 13,
`20, 21,
`22, 23,
`29
`12, 13,
`20, 21,
`22, 23,
`29
`12, 13,
`20, 21,
`22, 23,
`29
`22
`
`Woehr in view of Callaway
`
`Woehr in view of Villa
`
`Woehr in view of Callaway and further in
`
`view of Sutton
`
`Woehr in view of Villa and further in view of
`
`Sutton
`
`Woehr in view of Callaway and further in
`
`view of Nakajima
`
`VI
`
`103
`
`22
`
`Woehr in view of Villa and further in view of
`
`Nakajima
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`– 3 –
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`VII
`
`103
`
`22
`
`Woehr in view of Callaway and further in
`
`view of Sutton and further in view of
`
`Nakajima
`
`VIII
`
`103
`
`22
`
`Woehr in view of Villa and further in view of
`
`Sutton and further in view of Nakajima
`
`B. Relief Requested
`
`Petitioners request that the Board cancel the Challenged Claims because
`
`they are unpatentable under 35 U.S.C. §103.
`
`V. Overview of the State of the Art and the ’247 Patent
`A. The State of the Art
`
`The ’247 patent concerns a particular design for a catheter assembly. The
`
`term intravenous catheter is commonly used to describe the combination of a small
`
`gauge needle with a sharp tip used in combination with a plastic fitted tube to gain
`
`access to the vasculature and to withdraw or administer fluids. Modern IV
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`catheters have been in use since the 1950s when first introduced by Dr. David
`
`Massa at the Mayo Clinic. (Ex. 1002, Decl. ¶31).
`
`Since their introduction, IV catheters have undergone evolutionary changes.
`
`(Ex. 1002, Decl. ¶32). In the 1970s, improvements were primarily focused on
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`catheter tubing materials making them softer, more flexible and less traumatic to
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`the vessels during insertion. (Ex. 1002, Decl. ¶32).
`
`Since well before 2006, catheter assemblies incorporated blood control
`
`features such as valves and flash-back chambers. (Ex. 1002, Decl. ¶33). Catheter
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`assemblies also incorporated safety features intended to reduce the risk of
`
`accidental needle sticks since well before 2006. (Ex. 1002, Decl. ¶33). These
`
`improvements in ease of use and safety have also been driven by the move from a
`
`doctor dominated to a nurse dominated use environment. (Ex. 1002, Decl. ¶¶33-
`
`34).
`
`B.
`
`Brief Description of the ’247 Patent
`
`The ’247 patent was filed as a patent application on February 28, 2012, and
`
`claims priority to a U.S. patent application filed on November 3, 2006. The ’247
`
`patent describes an over-the-needle catheter insertion device. Figure 14,
`
`reproduced below, demonstrates the various claimed features of the catheter
`
`assembly, as annotated below.
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`– 5 –
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`The ’247 patent identifies three objectives for the disclosed catheter
`
`assembly. Ideally, the disclosed catheter should: (1) cover the tip of the needle
`
`immediately following use; (2) include a valve to minimize blood exposure
`
`following successful catheterization; and (3) incorporate a means for wiping the
`
`needle of the deposited blood on the needle as it is withdrawn from the catheter
`
`hub. (Ex. 1001, ’247 patent at 1:52-62). The devices covered in the challenged
`
`claims only accomplish the first two objectives, both of which were known in the
`
`art. (Ex. 1002, Decl. ¶¶35-39).
`
`In order to prevent accidental needle sticks, the ’247 patent discloses a
`
`number of tip protectors. Each of the disclosed tip protectors has at least one arm
`
`that covers the tip of the needle automatically as it is withdrawn. (Ex. 1002, Decl.
`
`¶¶40-41). The ’247 patent also discloses embodiments having a third housing that
`
`accommodates the tip protector. (Ex. 1001, ’247 patent at 11:18-21). All of the
`
`challenged claims have this feature.
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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` Blood control is accomplished by a valve that seals as 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, ’247 patent at 5:63-6:22,
`
`7:5-37, 11:10-11, 11:58-12:3; Ex. 1002, Decl. ¶42).
`
`The disclosed valve is formed from a thermoplastic elastomer that has a
`
`plurality of slits. (Ex. 1001, ’247 patent at 5:63-67). The ’247 patent states that
`
`the valve closes to form a seal when it is no longer deflected by the needle. (Ex.
`
`1001, id. at 7:5-7). Alternatively, the valve can provide a semi-permeable seal,
`
`allowing a slow flow of fluid. (Ex. 1001, id. at 7:15-19). The specification states
`
`that these features provide more time for a health care worker to connect an IV set
`
`to the catheter hub. (Ex. 1001, id. at 7:11-19; Ex. 1002, Decl. ¶43).
`
`The specification also discloses a valve opener that has an actuating end
`
`with a frusto-conical shape which pushes against the valve to open the valve and
`
`allow fluid flow. (Ex. 1001, ’247 patent at 6:14-18, 7:32-36). The valve opener
`
`has a pair of legs that are pushed forward when an IV-set Luer connector pushes
`
`into the opening of the catheter hub. (Ex. 1001, id. at 7:32-36). The legs then
`
`move the actuating end distally to open the valve. (Ex. 1001, id. at 7:36-39; Ex.
`
`1002, Decl. ¶44).
`
`All of these elements were known as of 2006, alone and in combination.
`
`The ’247 patent acknowledges that catheter assemblies having tip protectors were
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`known by incorporating by reference a number of tip protectors shown in prior art
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`publications. (Ex. 1001, ’247 patent at 6:53-7:4). Indeed, catheters having many
`
`different tip protector designs to prevent accidental needle sticks and/or to
`
`minimize blood exposure risks by preventing exposure to any fluids remaining on
`
`the needle after it is removed were well known as of 2006. Catheters having
`
`additional hubs or housing structures to house different tip protector designs were
`
`also known. (Ex. 1002, Decl. ¶45).
`
`By 2006, including valves and valve openers in catheter assemblies to
`
`prevent blood leakage from a catheter hub after a needle is withdrawn was a well-
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`known idea. (Ex. 1002, Decl. ¶¶46-49). The ’247 patent states that the valve used
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`in the disclosed catheter assembly “is widely commercially available and is a well
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`known component in the relevant art.” (Ex. 1001, ’247 patent at 6:1-3).
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`All of the above elements, with the possible exception of a third housing that
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`accommodates a tip protector, were disclosed in a 2004 publication of a PCT
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`patent application by one of the named inventors of the ’247 patent, Kevin Woehr.
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`(Ex. 1003; Ex. 1005; Ex. 1002, Decl. ¶50). Third housings to accommodate tip
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`protectors are disclosed by other references relied on in this Petition. (Ex. 1004,
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`Callaway; Ex. 1006, Villa; Ex. 1002, Decl. ¶51). A person skilled in the art would
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`have been motivated to add a tip protector housing to the design disclosed in the
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`Woehr 2004 PCT application to provide additional security for the tip protector so
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`– 8 –
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`the tip protector can prevent accidental needle sticks and/or to minimize blood
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`
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`exposure risks by preventing exposure to any fluids remaining on the needle after it
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`is removed. (Ex. 1002, Decl. ¶51-52). For example, US 2007/0038186 to Sutton
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`(“Sutton”), discloses that a “shroud” that “substantially encloses the needle guard”
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`provides the benefit of “reduc[ing] the likelihood of inadvertently activating the
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`needle guard or pulling the needle guard loose from the catheter hub.” (Ex 1009,
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`Sutton at [0011]; Ex. 1002, Decl. ¶¶68-69).
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`C.
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`Summary of the ’247 Patent’s Prosecution History
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`A U.S. family member of the Woehr reference, Application No. 13/451,406,
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`issued as Patent No. 8,333,735, (Ex. 1040) was cited as the basis for a nonstatutory
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`obviousness type double patenting during prosecution of the ’247 patent. The
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`patentee traversed this rejection by arguing that the ’406 application “does not
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`disclose any analogous third hub or housing of the claimed catheter
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`assembly.” (U.S. Patent Application No. 13/407,395 Prosecution History,
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`Response dated February 7, 2013) (Ex. 1010).
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`All of the Grounds in this petition include the Woehr reference in new
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`combinations with references that disclose a tip protector in a third hub of a
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`catheter assembly, and they are supported by new evidence, including the expert
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`testimony of Jack Griffis (Ex. 1002).
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`– 9 –
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`VI. Person of Ordinary Skill in the Art
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`
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`A POSA in 2006 would have been either a (i) a medical practitioner with
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`experience using vascular access devices and with training, experience and/or
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`familiarity applying principles of engineering to the design, development, and/or
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`testing of vascular access devices, or (ii) an engineer having at least a bachelor of
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`science degree and with several years of experience in the design, development,
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`and/or testing of vascular access devices and their clinical use; a higher level of
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`education could reduce the number of years of experience required. (Ex. 1002,
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`Decl. ¶28-30.)
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`– 10 –
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`VII. Claim Construction
`A.
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`“needle protective device”1
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`
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`In an inter partes review, the Board construes claim terms in an unexpired
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`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 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
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`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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`1 In litigation between Braun and BD, Braun has taken the position that “needle
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`protective device” is not governed by 35 U.S.C. § 112. Because that construction
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`is broader than the means-plus-function construction advanced in this petition and
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`because the prior art cited in this petition discloses tip protectors identical to the tip
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`protector disclosed in the ’247 patent, the “needle protective device” limitation is
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`met under any construction of the claims.
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`– 11 –
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`claim is governed by § 112, ¶ 6 whether or not the word “means” is used. Id. at
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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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) (“adjustable
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`connector” construed as a means-plus-function term); Adlens USA, Inc. v.
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`Superfocus Holdings LLC, 2016 WL 7992256, IPR2015-01821, Paper 38 (Final
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`Decision) at *4 (Dec. 27, 2016) (“adjustable element” and “controllable spacing
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`member” construed as means-plus-function terms); Verizon Servs. Corp. v. AIP
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`Acquisitions LLC, 2015 WL 9899021, IPR2015-01106, Paper 10 (Institution of
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`Inter Partes Review) at *10 (Oct. 15, 2015) (“checking device” and “identifying
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`device” construed as means-plus-function terms); Apple Inc. v. Immersion Corp.,
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`2017 WL 376909, IPR2016-01372, Paper 7 (Institution of Inter Partes Review) at
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`*6 (Jan. 11, 2017) (“drive module” construed as a means-plus-function-term).
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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; In re
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`Donaldson Co., 16 F.3d 1189, 1195 (Fed. Cir. 1994) (en banc); see also Adlens,
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`2016 WL 7992256, at *4; Willis Elec. Co., Ltd. v. Polygroup Macau Ltd. (BVI),
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`IPR2017-00330, at 5-6 (May 25, 2017). The first step requires identifying the
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`claimed function. Id. The second step is identifying the structure in the patent
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`specification that performs the claimed function. Id. The claim term is construed
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`to cover those structures and all equivalents thereof. Id.
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`– 12 –
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`U.S. Patent No. 8,460,247
`Petition for Inter Partes Review
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`Claims 12, 13, 20, 21, 22, 23, and 29 recite a “safety catheter assembly
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`comprising . . . a needle protective device . . . configured to prevent unintended
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`needle sticks in a protective position.” The use of the word “device” in the claims
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`does not impart any structure and is tantamount to using the word “means.”
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`Williamson, 792 F.3d at 1350. The term “needle protective device” is not used,
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`nor is it defined, in the specification of the ’247 patent, nor is there extrinsic
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`evidence demonstrating that the term connotes sufficient structure.
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`The Board may also look to the modifiers of a nonce term to see if they
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`impart structure. Williamson, 792 F.3d at 1351 (“The prefix ‘distributed learning
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`control’ does not impart structure into the term ‘module.’”). If the modifier has no
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`dictionary definition and no generally understood structural meaning in the art,
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`then the term is a means-plus-function term. See MIT & Elecs. for Imaging, Inc. v.
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`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
`
`and has no dictionary definition, and there is no suggestion that it has a generally
`
`understood meaning in the art.”); Mas-Hamilton Grp. v. LaGard, Inc., 156 F.3d
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`1206, 1214