Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 1 of 24 PageID #: 9020
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`B. BRAUN MELSUNGEN AG, B. BRAUN
`MEDICAL INDUSTRIES SDN. BHD. and B.
`BRAUN MEDICAL, INC.,
`
`Plaintiffs;
`
`V.
`
`Civil Action No. 1 :16-cv-411-RGA
`
`BECTON, DICKINSON AND COMPANY
`and BECTON, DICKINSON INFUSION
`THERAPY SYSTEMS, INC.
`
`Defendants.
`
`MEMORANDUM OPINION
`
`Gregory E. Stuhlman, Esq., GREENBERG TRAURIG, LLP, Wilmington, DE; Julie P.
`Bookbinder, Esq. (argued), GREENBERG TRAURIG, LLP, New York, NY; Scott J. Bornstein,
`Esq., GREENBERG TRAURIG, LLP, New York, NY; Allan A. Kassenoff, Esq. (argued),
`GREENBERG TRAURIG, LLP, New York, NY; Joshua L. Raskin, Esq. (argued),
`GREENBERG TRAURIG, LLP, New York, NY.
`
`Attorneys for Plaintiffs
`
`Frederick L. Cottrell, Esq., RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE;
`Katharine L. Mowery, Esq., RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Nicole
`K. Pedi, Esq., RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; William F. Lee, Esq.,
`WILMER CUTLER PICKERING HALE AND DORR LLP, Boston, MA; William G.
`McElwain, Esq. (argued), WILMER CUTLER PICKERING HALE AND DORR LLP,
`Washington, DC; Tracey C. Allen, Esq., WILMER CUTLER PICKERING HALE AND DORR
`LLP, Washington, DC; Omar A. Khan, Esq. (argued), WILMER CUTLER PICKERING HALE
`AND DORR LLP, New York, NY.
`
`Attorneys for Defendants
`
`August 1_, 2017
`
`1
`
`B. Braun 2002
`
`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 2 of 24 PageID #: 9021
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`Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent
`
`Nos. 9,149,626 ("the '626 patent'), 8,540,728 ("the '728 patent"), 8,337,463 ("the '463 patent"),
`
`8,333,735 ("the '735 patent"), 8,328,762 ("the '762 patent"), 8,460,247 ('"the '247 patent"),
`
`8,587,249 ("the '249 patent"), 9,370,641 ("the '641 patent"), 8,414,539 ("the '539 patent"),
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`8,444,605 ("the '605 patent"), and 8,545,454 ("the '454 patent"). The Court has considered the
`
`Parties' Joint Claim Construction Brief. (D.I. 110). The Court heard oral argument on June 8,
`
`2017. (D.I. 130).
`
`I.
`
`Background
`
`Plaintiffs brought this infringement action on June 6, 2016, alleging infringement of ten
`
`patents. (D.I. 1). On July 25, 2016, Plaintiffs filed their First Amended Complaint adding an
`
`additional count alleging infringement of an eleventh patent. (D.I. 16). The parties divide the
`
`patents into three families: the Woehr/Raines patents (the '626, '728, '463, '735, and '762 patents),
`
`the Woehr/Zerbes patents (the '247, 249, and '641 patents), and the Kuracina patents (the '539,
`
`'605, and '454 patents). All of these patents claim catheter insertion devices with needle protection
`
`components.
`
`II.
`
`Legal Standard
`
`"It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). "'[T]here is no magic formula or
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`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
`
`weight to appropriate sources 'in light of the statutes and policies that inform patent law."'
`
`SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
`
`1
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`2
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 3 of 24 PageID #: 9022
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`415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the
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`literal language of the claim, the patent specification, and the prosecution history. Markman v.
`
`Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370
`
`(1996). Of these sources, "the specification is always highly relevant to the claim construction
`
`analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term."
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`Phillips, 415 F.3d at 1315 (internal quotation marks omitted).
`
`"[T]he words of a claim are generally given their ordinary and customary meaning ....
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`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention, i.e., as of the effective filing date of the patent application."
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`Id. at 1312-13 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a
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`claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
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`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
`
`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
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`construction in such cases involves little more than the application of the widely accepted
`
`meaning of commonly understood words." Id. at 1314.
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`When a court relies solely upon the intrinsic evidence-the patent claims, the
`
`specification, and the prosecution history-the court's construction is a determination oflaw.
`
`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
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`make factual findings based upon consideration of extrinsic evidence, which "consists of all
`
`evidence external to the patent and prosecution history, including expert and inventor testimony,
`
`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks
`
`omitted). Extrinsic evidence may assist the court in understanding the underlying technology,
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`the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic
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`2
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`3
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 4 of 24 PageID #: 9023
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`evidence, however, is less reliable and less useful in claim construction than the patent and its
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`prosecution history. Id.
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`"A claim construction is persuasive, not because it follows a certain rule, but because it
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`defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per Azioni,
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`158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude
`
`the inventor's device is rarely the correct interpretation." Osram GMBHv. Int'! Trade Comm ·n,
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`505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation and internal quotation marks omitted).
`
`Ill. CONSTRUCTION OF DISPUTED TERMS
`
`A.
`
`1.
`
`The Patents-in-Suit
`
`The Woehr/Raines Patents
`
`The Woehr/Raines patents are directed to devices, systems, and methods for catheter
`
`insertion. The only disputed terms in the '626 patent appear in claim 11, which reads as follows:
`
`11.
`
`A catheter insertion device comprising:
`a catheter hub comprising an interior cavity, an opening at a proximal end,
`and a catheter tube attached to a distal end;
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a needle hub, said needle projecting through the catheter tube in a ready
`position and comprises a needle tip;
`a valve positioned inside the interior cavity of the catheter hub and in
`contact with the interior cavity, said valve being sized and shaped to obstruct fluid
`flow and comprises a wall surface comprising a slit; said valve remaining inside
`the interior cavity when the needle is removed from the catheter tube and the
`catheter hub;
`a valve actuating element slidingly disposed in the catheter hub to actuate
`the valve, the valve actuating element comprising a nose section having a tapered
`end for pushing the valve to open the slit and a plunger end extending proximally
`of the nose section; the plunger end transferring a distally directed force to the nose
`section to push the valve to open the slit when pressed upon; and
`a needle protective device spaced from the needle tip in the ready position
`and movable relative to the needle tip, at least in part distally of the needle tip to
`prevent unintended needle sticks.
`
`('626 patent, claim 11) (disputed terms italicized).
`
`3
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`4
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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 5 of 24 PageID #: 9024
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`Claim 1 of the '728 patent is representative and reads as follows:
`
`1.
`
`A catheter insertion device comprising:
`a catheter hub comprising an interior cavity, an opening at a proximal end,
`and a catheter tube attached thereto and extending from a distal end;
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a needle hub, said needle projecting through the catheter tube and
`comprising a needle tip;
`a valve sized and shaped to obstruct fluid flow comprising a wall surface
`comprising a slit positioned inside the interior cavity of the catheter hub and in
`contact with the interior cavity; said valve remaining inside the interior cavity when
`the needle is removed from the catheter tube and the catheter hub and abuts a
`shoulder formed in the interior cavity of the catheter hub;
`a valve actuating element slidingly disposed in the catheter hub to actuate
`the valve, the valve actuating element comprising a nose section having a tapered
`end for pushing the valve to open the slit of the valve and a plunger end having at
`least two plunger elements extending proximally of the nose section and having a
`gap therebetween to permit fluid flow to flow therethrough; the two plunger
`elements being sufficiently rigid to transfer a distally directed force to the nose
`section to push the valve to open the slit;
`a needle protective device spaced from the needle tip in a ready position and
`movable relative to the needle tip to a protective position, at least in part, distally
`of the needle tip to prevent unintended needle sticks.
`
`('728 patent, claim 1) (disputed terms italicized).
`
`Disputed terms in the '463 patent appear in claims 1 and 10. Claim 1 reads as follows:
`
`1.
`
`A catheter insertion device comprising:
`a catheter hub comprising an interior cavity, an opening at a proximal end,
`and a catheter tube attached thereto and extending from a distal end;
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a needle hub, said needle projecting through the catheter tube and
`comprising a needle tip;
`a valve sized and shaped to obstruct fluid flow through the catheter hub
`comprising a wall surface comprising a slit positioned inside the interior cavity of
`the catheter hub and abutting a shoulder in the interior cavity of the catheter hub;
`said valve remaining inside the interior cavity when the needle is removed from the
`catheter tube and the catheter hub;
`a valve actuating element slidingly disposed in the catheter hub to actuate
`the valve, the valve actuating element comprising a nose section having a tapered
`end for pushing the valve to open the slit of the valve and at least two plunger
`elements extending proximally of the nose section and having a gap therebetween
`to permit fluid flow to flow therethrough; the two plunger elements structured to
`transfer a distally directed force to the nose section to push the valve to open the
`slit;
`
`4
`
`5
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 6 of 24 PageID #: 9025
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`a needle protective device spaced from the needle tip in a ready position and
`movable relative to the needle tip to a protective position, at least in part, distally
`of the needle tip to prevent unintended needle sticks.
`
`('463 patent, claim I) (disputed terms italicized). Claim 10 of the '463 patent reads as
`
`follows:
`
`10.
`
`A catheter insertion device comprising:
`a first hub comprising an interior cavity, a perimeter defining an opening at
`a proximal end, and a catheter tube having a distal end opening extending distally
`of the first hub:
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a second hub, said needle projecting through the catheter tube and
`comprising a needle tip;
`a valve sized and shaped to obstruct fluid flow comprising a slit positioned
`inside the interior cavity of the first hub and having a distal surface pushed against
`a shoulder in the interior cavity; said valve remaining inside the interior cavity when
`the needle is removed from the catheter tube and the first hub;
`a valve actuating element slidingly disposed in the first hub to actuate the
`valve, the valve actuating element comprising a projection, a nose section having a
`tapered end with an opening structured to push the valve to open the slit, and at
`least two plunger elements extending proximally of the nose section and having a
`gap therebetween; wherein the at least two plunger elements with the gap
`therebetween are disposed distally of the proximal end of the first hub and are
`slidable distally when a male implement projects into the opening of the first hub
`to ~ansfer a distally directed force to the nose section to push the valve to open the
`slit;
`
`a needle protective device positioned proximal of the valve and at least in
`part around the needle and distal of the proximal end of the second hub in a ready
`position, the needle protective device is moveable to prevent unintended needle
`sticks in a protective position.
`
`('463 patent, claim 10) (disputed terms italicized).
`
`Claims 1 and 18 of the '735 patent are representative as to the disputed terms. Claim 1
`
`reads as follows:
`
`1.
`
`A catheter insertion device comprising:
`a catheter hub comprising an interior cavity, an opening at a proximal end,
`and a catheter tube attached thereto and extending from a distal end;
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a needle hub, said needle projecting through the catheter tube and
`comprising a needle tip;
`
`5
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`6
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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 7 of 24 PageID #: 9026
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`a valve configured to obstruct fluid flow compnsmg a wall surface
`comprising a slit positioned inside the interior cavity of the catheter hub; said valve
`remaining inside the interior cavity when the needle is removed from the catheter
`tube and the catheter hub;
`a valve actuating element slidingly disposed in the catheter hub configured
`to actuate the valve, the valve actuating element comprising a nose section having
`a tapered end for pushing the valve to open the slit of the valve and at least two
`plunger elements extending proximally of the nose section and having a gap
`therebetween to permit fluid flow to flow therethrough; the two plunger elements
`configured to transfer a distally directed force to the nose section to push the valve
`to open the slit;
`a needle protective device spaced from the needle tip in a ready position and
`movable relative to the needle tip to a protective position, at least in part, distally
`of the needle tip to prevent unintended needle sticks.
`
`('735 patent, claim 1) (disputed terms italicized). Claim 18 reads as follows:
`
`18.
`
`A catheter insertion device comprising:
`a catheter hub comprising an interior cavity comprising a shoulder, an
`opening at a proximal end, and a catheter tube attached thereto and extending from
`a distal end;
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a needle hub, said needle projecting through the catheter tube and
`comprising a needle tip;
`a valve configured to obstruct fluid flow positioned inside the interior cavity
`of the catheter hub; said valve remaining inside the interior cavity of the catheter
`hub when the needle is removed from the catheter tube and the catheter hub;
`a valve actuating element slidingly disposed in the catheter hub for actuating
`the valve, the valve actuating element comprising a nose section having a tapered
`end configured to open the valve, a projection on the valve actuating element
`located proximally of the tapered nose section engaging the shoulder of the catheter
`hub, and a plunger end extending proximally of the nose section having one or more
`gaps to permit fluid flow to flow therebetween and to transfer a distally directed
`force to the nose section to open the valve;
`a needle protective device positioned, at least in part, around the needle
`between the valve and the proximal end of the needle hub in a ready position and
`configured to prevent unintended needle sticks in a protective position.
`
`('735 patent, claim 18) (disputed terms italicized).
`
`Claim 18 of the '762 patent is representative and reads as follows:
`
`18.
`
`A method of manufacturing a catheter insertion device comprising:
`forming a catheter hub comprising a body comprising an interior cavity
`with an opening at a proximal end and attaching a catheter tube thereto;
`
`6
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`7
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 8 of 24 PageID #: 9027
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`positioning a valve in sealing communication with the interior cavity of
`the catheter hub for regulating fluid flow through the interior cavity;
`positioning a valve actuating element in mechanical communication with
`the valve for deflecting the valve to permit fluid flow through the interior
`cavity of the catheter hub;
`positioning a needle protective device at least partially inside the interior
`cavity of the catheter hub such that the needle protective device is in-line
`with the catheter hub and the valve actuating element;
`positioning a needle hub having a needle attached thereto proximally of
`the catheter hub so that the needle projects through the catheter hub and the
`catheter tube; and
`wherein the valve remains inside the interior cavity of the catheter hub
`when the needle is removed from the catheter tube and the catheter hub.
`
`('762 patent, claim 18) (disputed terms italicized).
`
`2.
`
`The Woehr/Zerbes Patents
`
`The Woehr/Zerbes patents are directed to catheter assemblies with needle protection
`
`features. The disputed terms in the '247 patent appear in independent claims 12 and 23 and
`
`dependent claims 22 and 29. Claim 12 is representative of the independent claims and reads as
`
`follows:
`
`12.
`
`A safety catheter assembly comprising:
`a first hub comprising an interior cavity, an opening at a proximal end,
`and a catheter tube having a distal end opening extending distally of the first
`hub;
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a second hub, said needle projecting through the catheter tube and
`comprising a needle tip;
`a valve comprising a slit for obstructing fluid flow positioned inside the
`interior cavity of the first hub; said valve remaining inside the interior cavity
`when the needle is removed from the catheter tube and the first hub;
`a valve actuating element slidingly disposed in the first hub for actuating
`the valve, the valve actuating element comprising a nose section having a
`tapered end with an opening configured to push the valve to open the slit
`and at least two leg elements extending proximally of the nose section and
`having a gap therebetween; wherein the at least two leg elements with the
`gap therebetween are disposed distally of the opening at the proximal end
`of the first hub and are slidable distally by a male implement projecting into
`the opening of the first hub to transfer a distally directed force to the nose
`section to push the valve to open the slit;
`
`7
`
`8
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 9 of 24 PageID #: 9028
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`a needle protective device positioned proximally of the valve and at least
`in part around the needle and distal of a proximal end of the second hub in
`a ready position and configured to prevent unintended needle sticks in a
`protective position;
`wherein an arm extends distally of a third hub and is located at east in part
`in the first hub in a ready position; and
`wherein a portion of the needle protective device springs relative to the
`needle to move to the protective position.
`
`('247 patent, claim 12) (disputed terms italicized). Dependent claim 22 reads as follows:
`
`22.
`
`The safety catheter assembly of claim 21, wherein the valve actuating
`element remains engaged to the valve to open the slit for fluid flow through
`the first hub.
`
`('247 patent, claim 22) (disputed terms italicized).
`
`The only disputed term in the '249 patent appears in claim 1, which reads as follows:
`
`1.
`
`A catheter assembly comprising:
`a first hub comprising an interior cavity, an opening at a proximal end,
`and a catheter tube having a distal end opening extending distally of the first
`hub;
`a needle having a needle shaft defining a needle axis projecting distally of
`an end of a second hub, said needle projecting through the catheter tube and
`comprising a needle tip;
`a valve comprising a slit for obstructing fluid flow and a skirt section
`positioned inside the interior cavity of the first hub such that the skirt section
`contacts the interior cavity of the first hub; said valve remaining inside the
`interior cavity when the needle is removed from the catheter tube and the
`first hub;
`a valve opener disposed in the first hub for actuating the valve, the valve
`opener comprising a nose section for pushing the valve to open the slit when
`activated and a leg element extending proximally of the nose section;
`wherein the leg element is slidable distally within the interior cavity of the
`first hub by a male implement to transfer a distally directed force to the nose
`section to push the valve to open the slit;
`a needle protective device spring loaded in a ready to use position and
`positioned proximally of the valve and at least in part around the needle to
`prevent unintended contact with the needle tip in a protective position; and
`a third hub positioned substantially proximally of the first hub.
`
`('249 patent, claim 1) (disputed terms italicized).
`
`8
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`9
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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 10 of 24 PageID #: 9029
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`The disputed terms in the '641 patent appear in independent claim 15 and dependent
`
`claims 20 and 22. Claim 15 is representative and reads as follows:
`
`15.
`
`A safety catheter assembly comprising:
`a catheter hub comprising a housing comprising an exterior surface and
`an interior surface defining an interior cavity; said catheter hub having a
`catheter tube attached to a distal end of the catheter hub and the catheter
`tube comprising a distal opening;
`a needle hub having a needle with a needle tip attached to the needle hub
`and projecting distally of the needle hub and into the catheter tube with the
`needle tip extending out the distal opening of the catheter tube;
`a valve for limiting fluid flow and a valve opener in cooperative
`arrangement therewith positioned in the interior cavity of the catheter hub;
`a safety device for covering the needle tip comprising a tip protector
`housing having a housing section positioned proximally of a proximal end
`of the catheter hub; and
`wherein the valve opener comprises two proximally extending legs having
`a gap therebetween, the two proximally extending legs being sized and
`shaped to be pushed distally towards the valve to transfer a force imparted
`by a male Luer to the valve.
`
`('641 patent, claim 15) (disputed terms italicized).
`
`3.
`
`The Kuracina Patents
`
`The Kuracina patents are directed to intravenous catheter assemblies with needle tip
`
`guards. The only disputed term in each of the three Kuracina patents is "needle trap." This term
`
`appears in claims 1, 15, and 17 of the '539 patent, claims 1, 25, and 30 of the '605 patent, and
`
`claims 1, 18, 23, and 24 of the '454 patent. Claim 1 of the '539 patent is representative with
`
`respect to this disputed term and reads as follows:
`
`1.
`
`An intravenous catheter assembly comprising:
`a catheter hub with a catheter tube;
`a needle having a needle shaft, a proximal end attached to a needle hub, a
`sharpened distal end, and a change in profile;
`a needle guard slidably disposed about said needle shaft, said needle guard
`comprising a needle trap, the needle trap comprising an extending arm and
`a projection for releasably holding the catheter hub in a ready to use
`position; the needle guard further comprising an inner chamber and a slot
`for fixedly attaching the needle trap into the slot;
`
`9
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`10
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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 11 of 24 PageID #: 9030
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`wherein the projection is free to move to allow the catheter hub to separate
`from the needle guard when the needle trap is no longer biased by the
`needle; and
`an opening on the needle guard for interacting with the change in profile
`to limit distal advancement of the needle guard along the needle.
`
`B.
`
`1.
`
`(' 539 patent, claim 1) (disputed terms italicized).
`
`Disputed Terms
`
`"needle protective device ... movable relative to the needle tip to a protective position, at
`least in part, distally of the needle tip"
`
`a.
`
`b.
`
`c.
`
`Plaintiffs' proposed construction: "needle protective device and needle tip are
`movable with respect to each other to a protective position, where a portion of the
`needle protective device is located distally of the needle tip"
`
`Defendants' proposed construction: "The needle protective device moves from
`one position to a second position that covers the needle tip and that is, at least in
`part, distal of the needle tip."
`
`Court's construction: "The needle protective device moves from one position to a
`second position that covers the needle tip and that is, at least in part, distal of the
`needle tip."
`
`This term appears in the '735, '728, and '626 patents. The only dispute is whether the
`
`needle protective device itself must be movable, or whether the needle protective device may be
`
`stationary while only the needle tip moves to the protective position. Defendants do not argue that
`
`the needle itself cannot be movable; rather, they contend that the plain language of the claim
`
`requires that the needle protective device must be movable. (Hr' g Tr. at 78:20-79: 1 ). Plaintiffs
`
`focus on the words "relative to" as support for their argument that all this claim language requires
`
`is that either the needle protective device or the needle tip, or both, can move, as long as the two
`
`move relative to each other. (Hr'g Tr. at 71: 16-72:3). I disagree. The plain language of this term
`
`supports Defendants' construction. Movable modifies "needle protective device," not "needle
`
`tip." A plain reading of this indicates that the "needle protective device" must be movable. Indeed,
`
`Plaintiffs admit that the "needle protective device" is movable in every embodiment disclosed in
`
`10
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`11
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 12 of 24 PageID #: 9031
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`the specification. (Hr' g Tr. at 77: 15-17). There is nothing in the patent, therefore, to indicate that
`
`the patentee intended for this claim language to mean anything other than what a plain reading of
`
`it means; that is, the "needle protective device" must be movable. Therefore, I will adopt
`
`Defendants' proposed construction.
`
`2.
`
`"the valve actuating element remains engaged to the valve to open the slit"
`
`a.
`
`b.
`
`c.
`
`Plaintiffs' proposed construction: "the valve actuating element causes the valve
`slit to remain open after the male implement is withdrawn from the catheter hub;
`Not indefinite under§ 112"
`
`Defendants 'proposed construction: "element is in contact with the valve and is
`configured to open the slit; alternatively, indefinite under § 112"
`
`Court's construction: "the valve actuating element causes the valve slit to remain
`open"
`
`This term appears in the '247 patent in asserted dependent claim 22, which depends through
`
`a series of other claims from independent claim 12. Plaintiffs contend that Defendants' proposed
`
`construction limits the claim to a device in the ready position, while Plaintiffs argue the device is
`
`not necessarily in the ready position. (Hr'g Tr. at 96:14-18). Defendants argue that claim 12 is a
`
`product claim that specifically describes a safety catheter in the ready position. (D.I. 110 at 27).
`
`Plaintiffs disagree, arguing that claim 12 merely describes the "different attributes of the claimed
`
`safety catheter assembly," including when it is not in the ready position. (Hr' g Tr. at 99:8-15). I
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`agree with Defendants that claim 12 describes the safety catheter assembly in the ready position.
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`This is clear from the fact that the claim calls for a needle to be present "projecting through the
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`catheter tube." Claim 12, however, does describe features of the assembly in other positions, such
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`as after "the needle is removed." As discussed below, I find that Claim 22 describes the assembly
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`after the needle has been removed and the valve has been opened. Therefore, I find this term is
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`not indefinite under§ 112.
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`11
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`12
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 13 of 24 PageID #: 9032
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`The parties further disagree about which embodiment this claim is directed to. Plaintiffs
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`argue the claim is directed to the embodiment shown in Figure 5, while Defendants contend it is
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`the embodiment shown in Figure 9D. (Hr'g Tr. at 96:19-97:1, 105:7-10). I agree with Plaintiffs
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`that this claim is directed to the embodiment shown in Figure 5. The specification states that the
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`distinctive feature of the alternative safety catheter, whose embodiment is shown in Figure 9D, is
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`"an air permeable fluid impermeable wiper ... incorporated distal of the valve." ('247 patent at
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`9:48-49). This embodiment is described as being otherwise "similar" to the catheter assembly
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`disclosed earlier in the specification, including the assembly pictured in Figure 5. (Id. at 9:44-47)
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`The wiper feature that distinguishes this embodiment does not appear in claim 22 or any of the
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`claims from which claim 22 depends. The specification's discussion of Figure 9D also does not
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`mention the limitation found in claim 22, that "the valve actuating element remains engaged to the
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`valve." Therefore, I do not find Figure 9D to disclose a relevant embodiment of the catheter
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`assembly.
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`The specification's disclosure regarding Figure SA, on the other hand, contains the only
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`disclosure in the entire specification of the actuating element and valve "remain[ing] engaged."
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`('247 patent at 7:37-39). This portion of the specification indicates that the two elements become
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`"engaged" only after the valve opener (the valve actuating element) has been pushed forward into
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`the valve, "forc[ing] the cut-out to deflect," and thereby opening the valve. (Id. at 7:33-37). The
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`specification further provides that, "If the IV set luer connector is subsequently withdrawn from
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`the catheter hub, then the valve would remain open and consequently there could be blood
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`leakage." (Id. at 7:44-46). I think this disclosure indicates that if the two elements are "engaged,"
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`then the valve is open. I do not think, however, that the only time the valve remains open is after
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`the male implement, or IV set luer, is withdrawn.
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`I see no reason to import this additional
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`12
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`13
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`

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`Case 1:16-cv-00411-RGA Document 173 Filed 08/08/17 Page 14 of 24 PageID #: 9033
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`limitation into the meaning of this claim term as neither claim 22 nor any of the claims from which
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`it depends mention the male implement having been withdrawn. Nor does the engagement of the
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`two elements imply or require that the male implement be withdrawn. Therefore, I will construe
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`this term to mean "the valve actuating element causes the valve slit to remain open."
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`3.
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`"plunger"
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`a.
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`b.
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`Plaintiffs' proposed construction: "No construction necessary. Alternatively:
`structure that transfers an external force"
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`Defendants' proposed construction: "A longitudinal structure that receives an
`external force that moves the structure along the longitudinal axis"
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`c.
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`Court's construction: "Plain and ordinary meaning."
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`As discussed at oral argument, I am not convinced that this term needs to be construed as
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`I think it has an ordinary meaning to a person of skill in the art. (Hr'g Tr. at 112:3-6). Therefore,
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`I will provisionally construe the term "plunger" to have its plain and ordinary meaning. (Hr'g Tr.
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`at 115: 1-9). If, closer to trial, the parties determine that this term needs construction beyond plain
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`and ordinary meaning, they should make a request with the Court for further claim construction.
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`4.
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`"needle protective device positioned proximal of the valve and at least in part around the
`needle and distal of the proximal end of the second hub"
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`"a needle protective device positioned, at least in part, around the needle between the
`valve and the proximal end of the needle hub"
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`a.
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`b.
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`Plaintiffs' proposed construction: "needle protective device positioned proximal
`of the valve and at least in part: (i) around the needle, and (ii) distal of the