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`Paper No. 7
`
`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.
`
`______________
`
`
`
`Case IPR2017-01585
`Patent 8,337,463
`
`______________
`
`Patent Owner’s Preliminary Response
`
`
`
`

`

`
`
`I. 
`
`II. 
`
`Table of Contents
`
`INTRODUCTION ........................................................................................ 1 
`
`LEVEL OF ORDINARY SKILL IN THE ART ....................................... 4 
`
`III.  CLAIM CONSTRUCTION ........................................................................ 5 
`
`A. 
`
`B. 
`
`C. 
`
`Background and Overview of the Law ................................................ 5 
`
`“Needle Protective Device” is Synonymous with “Needle Guard
`Element” ............................................................................................... 6 
`
`“Needle Protective Device” a.k.a. “Needle Guard Element” is
`Not a Means-Plus-Function Term ...................................................... 9 
`
`1.  The ’463 Patent Discloses “Needle Protective Device” is A
`Structure ............................................................................................... 9 
`
`2.  The Prosecution History Teaches “Needle Protective
`Device” is A Structure ....................................................................... 12 
`
`3.  “Needle Protective Device” is a Class of Structures
`Well-Known to a POSITA ................................................................ 13 
`
`4.  Surrounding Claim Language Indicates “Needle Protective
`Device” is Structural and Not Limited to Spring Clips ................. 16 
`
`IV.  STANDARD FOR INSTITUTING INTER PARTES REVIEW ........... 18 
`
`V. 
`
`THE BOARD SHOULD DENY INSTITUTION OF GROUND 1
`BECAUSE IT IS BASED ON THE SAME PRIOR ART AND
`SUBSTANTIALLY THE SAME ARGUMENTS ALREADY
`CONSIDERED BY THE OFFICE ........................................................... 22 
`
`A. 
`
`B. 
`
`The Office has already determined it would not be obvious for a
`POSITA to incorporate a valve into the Woehr-108 catheters ......... 23 
`
`The Office already determined it would not be obvious to
`incorporate the valve assembly of Tauschinski into a catheter hub 26 
`
`Page i of vi
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`

`

`
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`Petitioner’s proposed combination of Woehr-108 and Tauschinski
`adds nothing beyond what was already considered by the Office .... 28 
`
`Arnett adds nothing beyond what is already disclosed in
`Tauschinski ......................................................................................... 30 
`
`Petitioner merely concludes, without supporting evidence, that it
`would be obvious to include Tauschinski’s disc 3 and member 10
`in the catheter hub of Woehr-108 ...................................................... 35 
`
`Patent Owner’s Australian expert never stated there were “no
`design concerns” with incorporating a valve into the catheter
`hub of Woehr-108 ............................................................................... 37 
`
`VI.  THE BOARD SHOULD DENY INSTITUTION OF GROUND 1
`BECAUSE PETITIONER FAILS TO SHOW HOW TO
`SUCCESSFULLY INCORPORATE A VALVE AND ACTUATOR
`INTO THE CATHETER HUB OF WOEHR-108 WHILE
`MAINTAINING THE FUNCTIONALITY OF THE WOEHR-108
`CATHETER ............................................................................................... 39 
`
`A. 
`
`B. 
`
`Significant design challenges exist for a POSITA considering
`incorporating a valve and actuator into the Woehr-108 catheter
`hub ....................................................................................................... 40 
`
`Petitioner never adequately explains how a POSITA would
`overcome the design challenges ......................................................... 45 
`
`C. 
`
`There is no reason to modify the Tauschinski actuator ................... 48 
`
`VII.  THE BOARD SHOULD DENY INSTITUTION ON GROUND 2
`BECAUSE VAN HEUGTEN DOES NOT DISCLOSE A VALVE
`WITH SLITS, AND BECAUSE THERE IS NO REASON TO USE
`THE ACTUATOR OF ARNETT WITH THE VALVE OF VAN
`HEUGTEN .................................................................................................. 51 
`
`A. 
`
`B. 
`
`Van Heugten fails to disclose a valve with slits, as required by all
`Challenged Claims.............................................................................. 52 
`
`There is no reason to modify the already existing actuator of
`Van Heugten based on Arnett ............................................................ 54 
`
`Page ii of vi
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`

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`
`
`
`
`VIII.  SECONDARY CONSIDERATIONS ....................................................... 58 
`
`IX.  CONCLUSION ........................................................................................... 59 
`
`
`
`Page iii of vi
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`

`

`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`ActiveVideo Networks, Inc. v. Verizon Communs., Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) .................................................................... 34, 36
`
`Page(s)
`
`In re Am. Acad. Of Sci. Tech. Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) ............................................................................ 5
`
`Apex Inc. v. Raritan Comp., Inc.,
`325 F.3d 1364 (Fed. Cir. 2003) ............................................................................ 6
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) .......................................................................... 34
`
`Cuozzo Speed Techs. v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 5
`
`Front Row Technologies, LLC v. MLB Advanced Media, L.P.,
`IPR2015-01932, Paper 7 (Mar. 24, 2016) .......................................................... 20
`
`Fujunon Corp. v. Motorola, Inc.,
`2009 U.S. Dist. LEXIS 83088 (D. Del. Sept. 11, 2009) ....................................... 9
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 19
`
`Inventio AG v. ThyssenKrupp Elevator Am. Corp.,
`649 F.3d 1350 (Fed. Cir. 2011) .......................................................................... 17
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 20
`
`Lighting World, Inc. v. Birchwood Lighting, Inc.,
`382 F.3d 1354 (Fed. Cir. 2004) ................................................................ 6, 13, 15
`
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ........................................................ 18, 19, 20, 52
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F. 3d 1348 (Fed. Cir. 2007) ......................................................................... 57
`
`Page iv of vi
`
`

`

`
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ...................................................................... 8, 12
`
`SAP America Inc. v. Clouding IP, LLC,
`IPR2014-00299, Paper 8 (July 9, 2014) ............................................................. 20
`
`Silver Star Capital, LLC v. Power Integrations, Inc.,
`IPR 2016-00736, Paper 11 (Aug. 26, 2016). ...................................................... 21
`
`In re Stepan Co.,
`2017 WL 3648528 (Fed. Cir. Aug. 25, 2017) .................................. 34, 36, 47, 50
`
`Wenger Mfg. v. Coating Mach. Sys.,
`239 F.3d 1225 (Fed. Cir. 2001) .......................................................................... 17
`
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) ............................................................................ 6
`
`Statutes
`
`35 U.S.C. § 103 .............................................................................................. 1, 19, 20
`
`35 U.S.C. §112 .......................................................................................................... vi
`
`35 U.S.C. § 314 ........................................................................................................ 18
`
`35 U.S.C. § 316 ........................................................................................................ 18
`
`35 U.S.C. § 325(d) .................................................................... 22, 23, 30, 35, 36, 39
`
`Other Authorities
`
`37 C.F.R. § 42.65 ..................................................................................................... 20
`
`37 C.F.R. § 42.100 ..................................................................................................... 5
`
`37 C.F.R. § 42.108 ................................................................................................... 18
`
`77 Fed. Reg. 48,756 (Aug. 14, 2012) ...................................................................... 18
`
`MPEP §2181(VI) ..................................................................................................... 12
`
`
`
`
`
`Page v of vi
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`

`

`
`
`Exhibit
`2001
`2002
`
`2003
`2004
`2005
`2006
`2007
`2008
`
`2009
`2010
`2011
`2012
`2013
`2014
`2015
`2016
`2017
`2018
`2019
`2020
`
`2021
`2022
`2023
`2024
`
`EXHIBIT LIST
`
`Description
`Declaration of Dr. Richard Meyst (“the Meyst Declaration”)
`Memorandum Opinion, Case No. 1:16-cv-411-RGA, D.I. 173 (D.
`Del. Aug. 8, 2017)
`File History of U.S. Patent No. 8,337,463
`File History of U.S. Patent No. 7,736,339 (“the ’339 file history”)
`File History of U.S. Patent No. 8,328,762
`File History of U.S. Application No. 14/860,253
`U.S. Patent No. 7,736,339 (“the ’339 patent”)
`European Patent Application Publication No. 0 352 928 A1 (“EP
`352,928”)
`U.S. Patent No. 6,001,080
`U.S. Patent No. 5,851,196
`U.S. Patent No. 6,379,333
`U.S. Patent No. 5,718,688
`35 U.S.C. §112 Supplementary Examination Guidelines (4/8/2011)
`U.S. RE 38,996
`WO 03/011381 (“Villa”)
`U.S. Patent No. 5,538,508
`U.S. Patent No. 5,348,544
`U.S. Patent No. 5,405,323 (“Rogers”)
`U.S. Patent No. 6,652,486 (“Bialecki”)
`ISO 594-01 (1986), “Conical fittings with a 6% (Luer) taper for
`syringes, needles and certain other medical equipment, General
`Requirements”
`Excerpt from Cambridge International Dictionary of English, 1995
`Excerpt from Webster’s II New College Dictionary, 2001
`Curriculum Vitae of Dr. Richard Meyst
`Materials Considered of Dr. Richard Meyst
`
`Page vi of vi
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Patent Owner, B. Braun Melsungen AG (“Patent Owner”), submits the
`
`following Preliminary Response to the Petition for Inter Partes Review (the
`
`“Petition”) filed by Becton, Dickson and Company (“Petitioner”) regarding Claims
`
`1, 2, 10, 12, 25 and 28 (“the Challenged Claims”) of U.S. Patent No. 8,337,463
`
`(“the ’463 Patent”). Petitioner has alleged that the Challenged Claims are
`
`unpatentable under 35 U.S.C. § 103(a) over several prior art references, using
`
`multiple grounds. (Petition at 3.) For the below reasons, the Board should deny
`
`Petitioner’s IPR request on all grounds.
`
`The ’463 patent relates to a catheter insertion device having a needle, a
`
`catheter hub, a valve, a valve actuator and a needle protective device, all in
`
`cooperative arrangement. FIGS. 1-2 of the ’463 patent, reproduced in annotated
`
`form below, are representative. As shown, and as claimed in the Challenged
`
`Claims, the valve (7) and actuator (10) are arranged in the catheter hub (2) in
`
`cooperative arrangement with the needle (9) and the needle guard element (needle
`
`protective device) (13).
`
`Page 1 of 59
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`

`

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`
`
`
`As the ’463 patent explains, the check valve (7) is arranged in the catheter hub (2)
`
`between the catheter (4) and the needle guard element (13). A hollow needle (9)
`
`extends through the valve (7), so that, after withdrawal of the hollow needle (9)
`
`from the catheter (4) the valve (7) can be reliably closed such that an outflow of
`
`blood is prevented, while simultaneously the tip (9a) of the hollow needle (9) is
`
`securely covered by the needle guard element (13) so that the operating personnel
`
`cannot injure themselves on the needle tip (9a). (Ex. 1001 at 1:38-47.)
`
`
`
`Petitioner raises two asserted grounds of invalidity in its Petition. (Petition at
`
`3.) All grounds should be denied for the reasons stated herein. Specifically,
`
`Ground 1 should be denied because it raises substantially the same art and
`
`arguments already considered and rejected by the Office. Ground 1 should also be
`
`denied because Petitioner’s obviousness contentions are based on merely
`
`Page 2 of 59
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`

`

`
`
`conclusory statements. Indeed, Petitioner’s allegations hinge on its argument that a
`
`person of ordinary skill in the art (“POSITA”) would find it obvious to include the
`
`valve and valve actuator of Tauschinski in the catheter hub of Woehr-108.
`
`However, Petitioner never explains how to actually combine a needle, a valve, a
`
`valve actuator, and a needle guard element within the space constrained catheter
`
`hub of Woehr-108.1 Rather than provide any substantive analysis, Petitioner
`
`merely relies on well-known catch phrases, such as “the combination is merely the
`
`combination of known elements.” (Petition at 20.) As one example, Petitioner’s
`
`expert states a POSITA would be motivated to add the valve of Tauschinski, but
`
`never explains how that would actually be accomplished. (Ex. 1002 at ¶68.) As
`
`another example, in arguing why a POSITA would combine Woehr-108,
`
`Tauschinski and Arnett, Petitioner and Petitioner’s expert state:
`
`74. A person of ordinary skill in the art would have found it obvious
`to combine Woehr ’108, Tauschinski, and Arnett, for the reasons
`described above in section X.A.4 (Ground I, element 1c). In
`particular, it would have been obvious to combine the catheter
`insertion device of Woehr ’108 with the valve actuating elements as
`disclosed in Tauschinski and Arnett. As discussed above, it would
`
`
`1 As discussed in greater detail below, industry standards in place since 1986
`
`require the internal diameter of Woehr-108’s catheter hub to be no larger than 4.315
`
`mm (0.170 inch). (Ex. 2020.)
`
`Page 3 of 59
`
`

`

`
`
`have been obvious for a person of ordinary skill to combine the
`catheter insertion device of Woehr ’108 with the valve as disclosed
`in Tauschinski. A valve actuating element would be required to
`actuate this valve to help transfer external force from a male luer
`connector or other similar instrument to the valve, so that the
`valve may be opened.
`
`(Ex. 1002 at ¶74 (emphasis added); see also, Petition at 24.) However, as Petitioner
`
`acknowledges, Tauschinski already has an acceptable actuator, so Petitioner’s
`
`argument is illogical. (Petition at 20-21.) There is simply no reason to use the
`
`actuator of Arnett with Tauschinski.
`
`As shown in detail below, Petitioner’s obviousness assertions in Ground 2
`
`are no better than its assertions in Ground 1. Thus, Patent Owner requests that the
`
`Board reject the Petition in its entirety, and decline to institute trial.
`
`II. LEVEL OF ORDINARY SKILL IN THE ART
`A POSITA at the time of the invention of the ’463 patent would have at least
`
`an associate’s degree in engineering or Physics or the equivalent, and at least five
`
`years of experience with IV catheters. Alternatively, more education, such as a
`
`Bachelor of Science degree, could reduce the number of years of experience to at
`
`least two years of experience. (Ex. 2001-Meyst at ¶¶26-28.)
`
`Page 4 of 59
`
`

`

`
`
`III. CLAIM CONSTRUCTION
`A. Background and Overview of the Law
`In an inter partes review, the Board construes claim terms according to their
`
`broadest reasonable interpretation in light of the specification. 37 C.F.R.
`
`§42.100(b); Cuozzo Speed Techs. v. Lee, 136 S. Ct. 2131, 2144-45 (2016). Claim
`
`language should be read in light of the specification as it would be interpreted by a
`
`POSITA. In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
`
`The Petition proposes the construction of only one term, “needle protective
`
`device,” which is found in all claims of the ’463 patent. (Petition at 7-10.)
`
`Petitioner contends “needle protective device” should be construed as a means-plus-
`
`function limitation under §112, ¶6. (Id.) Specifically, Petitioner alleges the
`
`function of the “needle protective device” is to prevent unintended needle-sticks,
`
`and the structure identified in the specification is a spring clip and structural
`
`equivalents thereof. (Id. at 10.)
`
`In the corresponding District Court litigation, Petitioner provided the same
`
`proposed construction for “needle protective device” as it did in its Petition. On
`
`August 8, 2017, the District Court issued its Markman Memorandum Opinion (Ex.
`
`2002), finding that “needle protective device” is a means-plus-function term. (Id. at
`
`20-23.) However, for the reasons discussed below, in the context of an IPR, where
`
`Page 5 of 59
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`

`

`
`
`the broadest reasonable interpretation standard is used, Petitioner’s proposed
`
`construction is incorrect.
`
`When a claim term does not include the word “means,” there is a rebuttable
`
`presumption that §112, ¶6 does not apply. Williamson v. Citrix Online, LLC, 792
`
`F.3d 1339, 1348 (Fed. Cir. 2015). Petitioner must overcome this presumption by a
`
`preponderance of the evidence. Apex Inc. v. Raritan Comp., Inc., 325 F.3d 1364,
`
`1372 (Fed. Cir. 2003).
`
`In deciding whether a challenger has rebutted the presumption, “[t]he
`
`standard is whether the words of the claim are understood by persons of ordinary
`
`skill in the art to have a sufficiently definite meaning as the name for structure.”
`
`Williamson, 792 F.3d at 1349. As the Federal Circuit has held: “[I]t is sufficient if
`
`the claim term is used in common parlance or by persons of skill in the pertinent art
`
`to designate structure, even if the term covers a broad class of structures and even if
`
`the term identifies the structures by their function.” Lighting World, Inc. v.
`
`Birchwood Lighting, Inc., 382 F.3d 1354, 1359-60 (Fed. Cir. 2004).
`
`B.
`
`“Needle Protective Device” is Synonymous with “Needle Guard
`Element”
`
`Although “needle protective device” is not expressly recited in the ’463
`
`patent specification, a POSITA would understand from the specification and
`
`prosecution history that “needle protective device” is synonymous with, and should
`
`be construed as, “needle guard element.” (Ex. 2001-Meyst at ¶¶29-41.) For
`
`Page 6 of 59
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`

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`
`
`example, the Summary equates the “needle protective device” of claim 1 with
`
`“needle guard element.” (Ex. 1001 at 1:39-48.) The Background and Detailed
`
`Description similarly teach that embodiments of the invention include a “needle
`
`guard element” which covers the tip of the needle to completely protect and block
`
`it. (Ex. 1001 at 1:22-34; 2:24-39.) Thus, Petitioner’s basis for its proposed
`
`construction, i.e., that the “term ‘needle protective device’ is not used . . . in the
`
`specification” (Petition at 8; Ex. 1002 at ¶21) should be rejected. In fact,
`
`Petitioner’s expert explicitly points to FIG. 1 and element 13 as the “needle
`
`protective device,” thus admitting “needle guard element” and “needle protective
`
`device” are synonymous (Ex. 1002 at ¶35):
`
`
`
`
`
`The Office also repeatedly interchanged “needle protective device” with
`
`“needle protective element” and/or “needle guard element” during prosecution of
`
`the ’463 patent and related patents:
`
`Page 7 of 59
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`

`

`
`
` The present and co-pending applications “each claim a catheter insertion
`
`device with a valve and a needle protective element” (Ex. 2003 at 70);
`
` “the prior art does not disclose or render obvious . . . a needle protective
`
`element in combination with the other limitations of the claims” (Ex. 2003
`
`at 109);
`
` Woehr ’108 teaches a “needle guard element” (Ex. 2004 at 121-124) and
`
`“Woehr [’108] teaches a needle protective device” (Ex. 2005 at 138-143);
`
` “Claim 1 of this application and claim 10 of the U.S. Patent No. 8,333,735
`
`are drawn to the same structural limitations of . . . a needle guard (claim
`
`10, needle protective device)” (Ex. 2006 at 98-100.)
`
`Critically, Petitioner’s expert never reviewed the prosecution history of the
`
`’463 patent or related patents (Ex. 1002 at ¶¶5-7, 43), and the Petition similarly
`
`ignores the relevant prosecution histories. (Petition at 7-10.) Patent Owner’s
`
`construction, which is consistent with all of the intrinsic evidence and is the
`
`broadest reasonable construction, is therefore the proper construction in the context
`
`of this IPR. See Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005)
`
`(prosecution history is intrinsic evidence that should be considered for claim
`
`construction).
`
`Page 8 of 59
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`

`

`
`
`C.
`
`“Needle Protective Device” a.k.a. “Needle Guard Element” is Not
`a Means-Plus-Function Term
`
`“Needle protective device,” does not include the word “means,” and
`
`therefore there is a rebuttable presumption that §112, ¶6 does not apply. Petitioner
`
`cannot overcome this presumption because the term provides sufficiently definite
`
`structure in light of the intrinsic evidence, knowledge in the art, and the surrounding
`
`claim language. (Ex. 2001-Meyst at ¶¶42-62.) Indeed, Patent Owner specifically
`
`used “means” in connection with the term “engaging means” in the patent
`
`specification (Ex. 1001 at 1:24-27, 2:33-41), and in the claims of an earlier family
`
`member (Ex. 2007 at claims 1 and 8), but Patent Owner deliberately did not use the
`
`term “means” in conjunction with the term “needle guard element”/“needle
`
`protective device.” Deliberately choosing not to use the word “means” in the
`
`specification or in the claims indicates the inventors did not intend to invoke §112,
`
`¶6 relative to “needle guard element,” and by extension, “needle protective device”.
`
`See, e.g., Fujunon Corp. v. Motorola, Inc., 2009 U.S. Dist. LEXIS 83088, at *16-17
`
`(D. Del. Sept. 11, 2009) (the inventor knew how to use a term in the specification
`
`but chose not to do so in claims, indicating the claim should not be so limited).
`
`1.
`
`The ’463 Patent Discloses “Needle Protective Device” is A
`Structure
`
`The ’463 patent states that the “needle guard element” a.k.a. “needle
`
`protective device” is a structure, such as a spring, that “cover[s] the needle tip,
`
`Page 9 of 59
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`

`

`
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`completely protecting and blocking it.” (Ex. 1001 at 2:29-41; see also 1:22-35,
`
`1:39-48, 3:17-27, 4:39-48, Figures 1-2, 4, 5, 7d, 8, 10.) Importantly, Petitioner
`
`admits that the specification teaches using spring clips to cover and block the
`
`needle tip to prevent needle-sticks (Petition at 10; Ex. 1002 at ¶¶35, 39.) See
`
`Square, Inc. v. REM Holdings 3, LLC, 2017 Pat. App. LEXIS 1514, at *79-82
`
`(Comm’r Pat. & Trademarks Feb. 27, 2017) (“rectifier” has sufficient structure as a
`
`class of devices where party provided examples of rectifiers, including diodes that
`
`perform the function of rectifying).
`
`But “needle protective device” is not limited to spring clips. Notably, the
`
`Background states, “The invention is based on the object of designing a catheter
`
`insertion device of the type described [in EP 352,928].” (Ex. 1001 at 1:31-34.) The
`
`referenced patent, EP 352,928, describes a needle guard element (30) that is
`
`comprised of a tubular distal portion (32) and a split proximal flange (34), which
`
`when it is moved over a slot in the needle (50), is supposed to fall into the slot to
`
`stop relative movement between the needle and the needle guard element (30):
`
`
`
`
`
`Page 10 of 59
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`

`

`
`
`(Ex. 2008 at Abstract; Figs. 5-6.) In contrast, the needle guard element 13 of the
`
`preferred embodiment of the ’463 patent springs closed to protect the needle tip
`
`before the engagement means 9b abuts the proximal wall 13c of the needle guard
`
`element (Ex. 1001 at excerpted Figs. 1-2):
`
`
`
`Thus, at least two structurally different “needle guard elements” are disclosed in the
`
`’463 patent specification. Additionally, the face of the ’463 patent cites numerous
`
`references (all known to a POSITA) disclosing a variety of structures that function
`
`to prevent unintended needle-sticks, including, but not limited to, U.S. Patent No.
`
`6,001,080 (Ex. 2009) (comprising a resilient member that advances a needle guard
`
`over a needle tip); U.S. Patent No. 5,851,196 (Ex. 2010) (comprising a needle that
`
`retracts into the body of a needle protector); U.S. Patent No. 6,379,333 (Ex. 2011)
`
`(comprising a tabbed disk that locks a needle into a needle shield); U.S. Patent No.
`
`Page 11 of 59
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`

`

`
`
`5,718,688 (Ex. 2012) (comprising a leaf spring that locks a needle tip protector to
`
`the end of a needle). Therefore, even if the Board found “needle protective device”
`
`was subject §112, ¶6, a finding which Patent Owner disputes, the structure should
`
`not be limited to a spring clip.
`
`2.
`
`The Prosecution History Teaches “Needle Protective
`Device” is A Structure
`
`In addition to equating “needle protective device” with “needle guard
`
`element,” the Office specifically found the term to be structural during prosecution
`
`of a related patent: “Claim 1 of this application and claim 10 of the U.S. Patent No.
`
`8,333,735 are drawn to the same structural limitations of . . . a needle guard (claim
`
`10, needle protective device)” (Ex. 2006 at 98-100). Additionally, under MPEP
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`§2181(VI), patent examiners are instructed to clearly express when language in a
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`claim is interpreted as invoking §112, ¶6. (See also Ex. 2013 at Slides 36-45.) That
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`no such interpretation was made indicates the Office does not consider “needle
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`protective device”/“needle guard element” to be subject to §112, ¶6. Phillips, 415
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`F.3d at 1317 (“prosecution history provides evidence of how the PTO and the
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`inventor understood the patent”). Further, as indicated supra III.B, Petitioner
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`wholly fails to address this intrinsic evidence.
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`Page 12 of 59
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`3.
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`“Needle Protective Device” is a Class of Structures Well-
`Known to a POSITA
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`The plain language of “needle protective device”/“needle guard element”
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`invokes a “class of structures” known to a POSITA (Ex. 2001-Meyst at ¶¶52-59),
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`which the Federal Circuit has held constitutes sufficient structure. See, e.g.,
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`Lighting World, 382 F.3d at 1359-60 (“connector assembly” does not bring to mind
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`a particular structure but is a term for structure and thus §112, ¶6 does not apply).
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`In fact, Petitioner’s own prior art patents describe “needle guards” for IV catheters.
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`For example, U.S. RE 38,996 (Ex. 2014) (cited on the face of the ’463 patent as
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`U.S. Patent No. 5,601,536) states: “Needle guards are of three types which either
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`hide the withdrawn needle within the needle carrying hub, require replacement of a
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`separate needle guard or include a sliding shield which can be positioned distally
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`over the used needle.” (Id. at 1:39-43.)
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`A POSITA would recognize “needle protective device”/“needle guard
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`element” refers to structures included in safety IV catheters that prevent unintended
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`needle-sticks by covering (i.e., protecting or guarding) the needle tip. (Ex. 2001-
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`Meyst at ¶¶52-59.) Literature contemporaneous with the filing of the patent
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`application makes clear this class of structures includes numerous devices designed
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`to reduce the risk of needle-sticks. (Id.) Petitioner’s own expert admits,
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`“[c]atheters including many different designs to prevent operating personnel from
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`injuring themselves were well known as of 2002” and “the device claimed in the
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`Page 13 of 59
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`’463 patent is composed of standard features in catheter assemblies.” (Ex. 1002 at
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`¶¶36, 38-39, 33.)
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`For example, WO 03/011381 (“Villa,” Ex. 2015), which claims priority to
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`July 31, 2001, is entitled Protective Device for a Needle and discusses needle
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`protective devices for IV catheters: “This invention . . . relates to a protective device
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`for a needle. . . . More particularly, the invention relates to a protective device
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`which is capable of avoiding accidental pricking or wounds being inflicted on
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`health staff during the use of the needles concerned.” (Id. at 1.) Villa teaches well-
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`known members of the class of needle protective devices, including retractable
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`needles, rings linked by a flexible wire, and devices which slidably cooperate with
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`the needle to block the needle tip. Other patents from before the priority date of the
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`’463 patent, including Petitioner’s own patents, also describe “needle protective
`
`devices”/“needle guard elements” in structural terms. See, e.g., U.S. Patent No.
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`5,538,508 (Ex. 2016) (entitled “Needle Protective Device,” see Abstract and
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`Figures); U.S. Patent No. 5,348,544 to Petitioner (Ex. 2017) (describing a “needle
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`guard” that may comprise a spring clip in FIGS. 1-8, elements 40 and 44).
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`In addition, in the corresponding District Court litigation, Petitioner’s expert
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`cited evidence showing that the term “needle guard” is used to refer to a class of
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`structures included in safety IV catheters that prevent unintended needle-sticks by
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`covering the needle tip. Specifically, Petitioner’s expert cited to a 1992 report by
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`Page 14 of 59
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`the New York State Department of Health, entitled “Pilot Study of Needlestick
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`Prevention Devices,” which Petitioner included as Ex. 1017 with its Petition. This
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`study recognizes needle guards (whether called “needle guard elements” or “needle
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`protective devices”) as a being a recognized class of structures in the context of
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`“catheter insertion devices,” as claimed:
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`IV CATHETERS
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`The insertion of an IV catheter involves….
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`Three safety catheters are currently marketed. (Appendix B-5) The
`safety features consist of a needle guard that is variations on
`providing a protective housing for a used stylet as it is withdrawn.
`A locking device prevents subsequent exposure of an unprotected
`stylet.
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`(Ex. 1017 at 27 (emphasis added).)
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`Moreover, dictionaries indicate “needle protective device”/“needle guard
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`element” has achieved recognition as a noun denoting structure. While there is no
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`definition for “needle protective device,” courts have looked to the definition of the
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`word(s) modifying the claim term. See, e.g., Lightning World, 382 F.3d at 1361
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`(relying on definition for “connector” with respect to “connector assembly”). Here,
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`needle is indisputably a noun denoting structure. (Ex. 2021). “Guard” is also
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`consistently defined as a noun denoting structure, e.g., “A device that prevents
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`injury, damage, or loss, esp.: a. An attachment or covering put on a machine to
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`Page 15 of 59
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`protect the operator.” (Ex. 2022.) Therefore, a POSITA understood “needle
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`protective device”/“needle guard element” is a structure in connection with IV
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`catheters that protects the operator from unintended needle-sticks. (Ex. 2001-Meyst
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`at ¶¶56-59.)
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`4.
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`Surrounding Claim Language Indicates “Needle Protective
`Device” is Structural and Not Limited to Spring Clips
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`The claim language following “needle protective device” also indicates the
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`term is structural. Claim 1 requires that the “needle protective device” be
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`physically “spaced from the needle tip in a ready position and movable relative to
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`the needle tip to a protective position, at least in part, distally of the needle tip.”
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`Independent claims 10, 18, and 25 add additional structural requirements that the
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`“needle protective device” be physically located “at least in part around the needle”
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`and positioned “proximal of the valve . . . and distal of the proximal end of the
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`second hub” or “between the valve and the proximal end of the needle hub.”
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`Further, dependent claims 5 and 14 indicate the “needle protective device is located
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`between the two plunger elements of the valve actuating element in the ready
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`position.” Dependent claim 6 indicates the “needle protective device comprises a
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`proximal wall and two arms that converge to a single point.” Dependent claims 9
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`and 17 indicates the “needle protective device comprises an arm that is located, at
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`least in part, in the” first hub or catheter hub. By describing the location of the
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`“needle protective device,” how it cooperates with the needle, and structural
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`requirements such as a wall and arm(s), a POSITA would understand it to be
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`structural. (Ex. 2001-Meyst at ¶¶60-62.) See Inventio AG v. ThyssenKrupp
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`Elevator Am. Corp., 649 F.3d 1350, 1356 (Fed. Cir. 2011) (finding sufficient
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`structure when claims “delineate the components that the [device] is connected to,
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`describe how the [device] interacts with those components, and