Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 10
`Entered: October 1, 2013
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`BECTON, DICKINSON AND COMPANY
`Petitioner
`
`v.
`
`ONE STOCKDUQ HOLDINGS, LLC
`Patent Owner
`_______________
`
`Case IPR2013-00235
`Patent 5,704,914
`_______________
`
`
`
`Before KEVIN F. TURNER, BRIAN J. McNAMARA, and
`ADAM V. FLOYD Administrative Patent Judges.
`
`FLOYD, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`Case IPR2013-00235
`Patent 5,704,914
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`
`I. BACKGROUND
`The standard for instituting an inter partes review is set forth in 35 U.S.C.
`§ 314(a):
`THRESHOLD – The Director may not authorize an inter partes
`review to be instituted unless the Director determines that the
`information presented in the petition filed under section 311 and any
`response filed under section 313 shows that there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of
`the claims challenged in the petition.
`
`Becton, Dickinson and Company (“BD” or “Petitioner”) filed a Petition
`(“Pet.”) to institute an inter partes review of claims 22-26, 28, 29, and 31 (the
`“challenged claims”) of U.S. Patent 5,704,914 (the “’914 patent”). 35 U.S.C.
`§ 311. One StockDuq Holdings, LLC (“One-SD” or “Patent Owner”) timely filed
`a Preliminary Response (“Prelim. Resp.”). Generally, One-SD contends that the
`Petition should be denied as to all challenged claims. We conclude that BD has
`satisfied its burden under 35 U.S.C. § 314(a) to show that there is a reasonable
`likelihood that Petitioner will prevail with respect to at least one of the challenged
`claims.
`The ’914 patent has been and is currently involved in district court litigation.
`On December 3, 2012, One-SD filed a complaint against BD alleging infringement
`of the ’914 patent. One StockDuq Holdings, LLC, 2:12-cv-03037 (W.D. Tenn.).
`Pet. 1; Prelim. Resp. 5-6. That case is ongoing.
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`to
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`Patent 55,704,914
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`
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`A. The ’9144 Patent (EEx. 1001)
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`
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`The ’914 paatent generrally relatees to the fieeld of catheeter assembblies used
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`place a catheter innto a liquidd-containinng region suuch as a bllood vessell (i.e.,
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`intravennous or IV)). Ex. 10001 (’914 paatent), col.
`1, ll. 1-8.
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`As describbed in the
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`ng been knoown. Id.,
`assemblie
`s have lon
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`Backgroound of thee Inventionn, catheter
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`914 patentt perceivedd problemss
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`col. 1, ll. 14-16. HHowever, tthe inventoors of the ’
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`with thee prior art ccatheter asssemblies. Namely, ssome of thee prior art
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`assembliess
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`allowedd the needlee to be expposed durinng the cathheterizationn process ccreating thee
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`possibillity of an aaccidental nneedle stickk. Id., col.. 1, ll. 45-550. Anotheer perceiveed
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`issue waas the posssibility of bblood leakaage from thhe needle dduring the
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`catheterrization proocess or ass a result off blood flaashback, raaising contaamination
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`concernns. Id., col. 1, l. 50 – col. 2, l. 3
`.
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`TThe inventoors have at
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`tempted too resolve thhese issuess and otherr perceivedd
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`shortcommings withh the catheeter assembbly depicteed in Figuree 4 of the ’’914 patennt—a
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`colorizeed and labeeled versioon of whichh is depicteed below.1
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`Case IPPR2013-002235
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`A T
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`1 The geeneral desccriptions prrovided heerein of thee ’914 pateent and prioor art catheeter
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`assembllies are nott intended to be compplete, but rrather to prrovide the
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`reader witth a
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`high-levvel understtanding of the preferrred emboddiments. Inn addition,
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`it should nnot
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`be inferrred from thhe followinng discussion that th
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`e claims arre limited tto the
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`preferreed embodimment of thee ’914 pateent describ
`ed.
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`Case IPPR2013-002235
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`Patent 55,704,914
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`ary portionhree primaade up of thmbly is maThe cathheter assem
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`s—catheteer 12 (greenn),
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`cather hhub 14 (redd), and needle body 220 (orange)). In use, sstop 48 is rreleased annd
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`needle 227 is advannced via neeedle sleevve 37. As nneedle 27 iis advanceed, it passess
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`throughh diaphragmm 34 (yelloow) which may contaain a deforrmable slit.. Needle 227 is
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`insertedd in the pattient and bllood flashbback can bee observedd in enlargeed hub lummen
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`24 as neeedle 27 coontains fennestrations 30 which aallow bloood flowing
`up needle
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`cannulaa 26 to fill eenlarged hhub lumen 224. Diaphhragm 34 pprevents thee blood froom
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`flowingg past catheeter hub lummen 14. NNext, guideewire 32 iss advancedd via guidewwire
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`sleeve 444 as depiccted in Figuure 3 of thee ’914 pateent (a colorrized and llabeled
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`
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`version of which iis includedd below).
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`If there
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`is no resisstance on gguidewire 332, catheterr 12 is inseerted into tthe patient
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`while siimultaneouusly holdinng down stoop 48 so thhat, as cathheter 12 is
`rted,
`being inse
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`er. Needlee 27
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`needle 227 and guidewire 32 do not advvance into
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`the patientt any furth
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`and guiddewire 32 are then fuully retractted, and neeedle body
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`20 is remooved, leaviing
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`attached t
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`catheterr 12 and caatheter hubb lumen 14
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`
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`to the patieent. A sidee access poort
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`54 may also be provided, buut is not vissible in Figgure 3, as tthe port is pperpendicuular
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`
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`to page.. See Ex. 11001 (‘9144 patent), col. 5, l. 65
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`– col. 6, l.. 49.
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`Case IPR2013-00235
`Patent 5,704,914
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`B. Exemplary Claim
`Claims 22 and 31 are the independent claims of the ‘914 patent at issue.
`Claim 31 is exemplary of the claims and recites:
`31. A catheter assembly comprising:
`a flexible catheter defining a passageway which extends between
`open proximal and distal ends[;]
`a catheter hub having a distal end attached to a proximal end of
`said catheter, said hub defining a lumen which extends
`between open proximal and distal ends and which
`communicates on a distal end thereof with said passageway[;]
`a flexible, resilient diaphragm which can be penetrated by a
`hypodermic needle, such as a catheter introducer needle, said
`diaphragm being attached to said hub to seal a proximal end
`of said hub lumen in a liquid tight manner for preventing a
`liquid which has been introduced into said hub lumen from
`said catheter, external to a needle which may be penetrating
`said diaphragm and projecting into said hub lumen, from
`flowing through said diaphragm beyond said hub[;]
`a needle attachment body removably connected to said hub[;] and
`a cannulated catheter introducer needle having a sharp tip on a
`free end thereof and having an opposite end attached to said
`body such that said introducer needle has a least one position
`relative to said body which is operative to project through said
`diaphragm, hub lumen and catheter passageway when said
`body is attached to said hub for introducing said catheter into
`a liquid containing region of a biological organism, said
`introducer needle defining at least one fenestration on a
`central portion thereof which communicates with a cannula of
`said introducer needle and with said hub lumen and which is
`positioned distally of said diaphragm when said introducer
`needle is disposed in said operative position.
`
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`Case IPR2013-00235
`Patent 5,704,914
`
`C. The Prior Art
`BD relies upon the following prior art references:
`U.S. Patent 5,697,914 (Ex. 1006) (“Brimhall”), issued Dec. 16, 1997;
`U.S. Patent 4,468,224 (Ex. 1007) (“Enzmann”), issued Aug. 28, 1984;
`U.S. Patent 5,098,395 (Ex. 1002) (“Fields”), issued Mar. 24, 1992;
`U.S. Patent 5,088,984 (Ex. 1012) (“Fields II”), issued Feb. 18, 1992;
`U.S. Patent 3,766,916 (Ex. 1005) (“Moorehead”), issued Oct. 23, 1973;
`U.S. Patent 4,068,659 (Ex.1011) (“Moorehead II”), issued Jan. 17, 1978;
`U.S. Patent 3,399,674 (Ex. 1003) (“Pannier”), issued Sept. 3, 1968;
`U.S. Patent 4,205,675 (Ex. 1010) (“Vaillancourt”), issued Jun. 3, 1980; and
`U.S. Patent 5,342,316 (Ex. 1014) (“Wallace”), issued Aug. 30, 1994. 2
`
`D. Evidence
`Additionally, BD relies upon the following evidence:
`The declaration of Thomas Vesely, M.D. (Ex. 1004) (“Vesely Decl.”);
`Response to Office Action dated Feb. 21, 1997 (Ex. 1008);
`Final Office Action dated May 21, 1997 (Ex. 1009); and
`The American Heritage Dictionary (3d ed. 1996) definition of “between,”
`pp. 179-180 (Ex. 1013).
`
`E. The Asserted Grounds
`BD challenges claims 22-26, 28, 29, and 31 as unpatentable under 35 U.S.C.
`§§102 and/or 103. The specific grounds asserted by BD are summarized in the
`following table (Pet. 15-60):
`
`2 While BD included Wallace in its list of prior art relied upon (Pet. 3), none of
`BD’s asserted grounds of unpatentability included Wallace.
`
` 6
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`Case IPR2013-00235
`Patent 5,704,914
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`
`Reference[s]
`Moorehead
`
`Basis
`§ 102
`
`Claims challenged
`22, 23, 25, 28, 29, 31
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
` 7
`
`
`
`
`
`Moorehead and
`Vaillancourt
`Moorehead, and Fields
`or Brimhall
`Moorehead or Fields,
`and Vaillancourt or
`Moorehead II, and
`Pannier
`Moorehead and
`Enzmann
`Moorehead,
`Vaillancourt, and
`Enzmann
`Moorehead, Fields or
`Brimhall, and
`Enzmann
`Moorehead or Fields,
`and Vaillancourt or
`Moorehead II, and
`Pannier and Enzmann
`
`3 With respect to claims 23, 25, 26, 28, and 29, BD argues that the claims are
`“obvious over the same references applied to claim 22, namely . . . Moorehead in
`view of Pannier.” Pet. 50, 55, 55, 58, and 59, respectively. However, BD did not
`assert the combination of Moorehead and Pannier with respect to claim 22. We
`assume BD intended to reference its combination of Moorehead or Fields, and
`Vaillancourt or Moorehead II, and Pannier.
`4 BD asserts that “claim 24 is obvious over Enzmann in combination with the same
`references applied to claim 22, namely . . . Moorehead in view of Pannier.”
`Pet. 53. However, BD did not assert Moorehead and Pannier as a combination
`with respect to claim 22. We assume BD intended to reference its combination of
`Moorehead or Fields, and Vaillancourt or Moorehead II, and Pannier.
`
`22, 23, 25, 26, 28, 29, 31
`
`22, 23, 25, 26, 28, 29, 31
`
`22, 23, 25, 26, 28, 29, 313
`
`24
`
`24
`
`24
`
`244
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`Case IPR2013-00235
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`Fields, and
`Vaillancourt or
`Moorehead II
`Fields or Brimhall, and
`Moorehead
`Fields or Brimhall, and
`Moorehead, and
`Enzmann
`Brimhall
`
`Brimhall, and
`Vaillancourt or
`Moorehead
`Brimhall and Fields
`
`Brimahall, Fields, and
`Vaillancourt or
`Moorehead II
`Brimhall, Fields, and
`Enzmann
`Brimhall, Fields, and
`Vaillancourt or
`Moorehead II, and
`Enzmann
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 102
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`22, 23, 25, 26, 28, 29, 31
`
`22, 23, 25, 26, 28, 29, 31
`
`24
`
`31
`
`31
`
`22, 23, 25, 26, 28, 29
`
`22, 23, 25, 26, 28, 29
`
`24
`
`24
`
`For the reasons described below, we institute an inter partes review of
`claims 22-26, 28, 29, and 31 based on the following grounds: (1) claim 31 as
`unpatentable under § 102(b) over Brimhall, (2) claims 22, 23, 25, 26, 28, and 29 as
`unpatentable under § 103(a) over Brimhall and Fields, and (3) claim 24 as
`unpatentable under 35 U.S.C. § 103(a) over Brimhall, Fields, and Enzmann. The
`grounds of institution are emphasized in the table above.
`
`F. Claim Construction
`As a step in our analysis for determining whether to institute a trial, we
`determine the meaning of the claims. Consistent with the statute and the
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`legislative history of the AIA, the Board will interpret claims using the broadest
`reasonable construction. See Office Patent Trial Practice Guide, 77 Fed. Reg.
`48756, 48766 (Aug. 14, 2012); 37 C.F.R. § 100(b). There is a “heavy
`presumption” that a claim term carries its ordinary and customary meaning. CCS
`Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). By “plain
`meaning” we refer to the ordinary and customary meaning the term would have to
`a person of ordinary skill in the art. In re Translogic Technology, Inc., 504 F.3d
`1249, 1257 (Fed. Cir. 2007). However, a claim term will not receive its ordinary
`meaning if the patentee acted as his own lexicographer and clearly set forth a
`definition of the disputed claim term in either the specification or prosecution
`history. “Although an inventor is indeed free to define the specific terms used to
`describe his or her invention, this must be done with reasonable clarity,
`deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Also, we must be careful not to read a particular embodiment appearing in the
`written description into the claim if the claim language is broader than the
`embodiment. See In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993)
`(“[L]imitations are not to be read into the claims from the specification.”).
`For purposes of this decision, we construe certain claim limitations as
`follows:
`
`1. Flexible catheter
`Both independent claims 22 and 31 recite “a flexible catheter.” The ’914
`patent specification does not shed any light on what “flexible” means as used in
`conjunction with “catheter.” The prosecution history of record is likewise
`unilluminating.5 Thus, for the purposes of the petition, we adopt the common and
`
`
`5 Response to Office Action dated February 23, 1996 (Ex. 1008) and a Final Office
`
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`Case IPR2013-00235
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`ordinary meaning of “flexible.”
`
`“Flexible” means “capable of bending easily without breaking.”
`Oxford on-line dictionary (http://oxforddictionaries.com/us/definition/
`american_ english/flexible).
`
`
`2. Flexible resilient diaphragm
`Both independent claims 22 and 31 recite “a flexible, resilient diaphragm.”
`A diaphragm is “a thin sheet of material forming a partition.” Oxford on-line
`dictionary (http://oxforddictionaries.com/us/definition/american_english/
`diaphragm). This definition is consistent with the Specification which depicts the
`“diaphragm” 34 as a thin partition. See, e.g., ’914 patent, Fig. 4. One-SD’s
`proposed construction defines “a diaphragm” as “a seal.”6 Pet. 6. While the
`diaphragm disclosed in the ’914 patent does serve as a seal, we do not believe that
`the purpose forms a part of the definition of “diaphragm.” Rather, the purpose is
`recited separately in both independent claims. Ex. 1001 (’914 patent), claim 22
`(“preventing the flow of a liquid through said hub lumen past said side access port
`and through the proximal end of said hub external to said introducer needle
`cannula”); and claim 31 (“to seal a proximal end of said hub lumen in a liquid tight
`manner for preventing a liquid which has been introduced into said hub lumen
`from said catheter, external to a needle which may be penetrating said diaphragm
`
`
`Action, dated May 12, 1997 (Ex. 1009) are the only portions of the prosecution
`history which have been introduced into the official record.
`6 BD did not offer any claim constructions nor did it contest those offered by One-
`SD.
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`and projecting into said hub lumen, from flowing through said diaphragm beyond
`said hub”). Thus, defining “a diaphragm” as “a seal” would introduce a
`redundancy into the claims. Further, the common and ordinary definition of
`“diaphragm” is “a thin sheet of material forming a partition” which does not
`require a seal per se.
`In addition, the diaphragm is recited as being “flexible” and “resilient.”
`Oxford’s On-line Dictionary defines “flexible” as “capable of bending easily
`without breaking,” whereas, “resilient” is defined as “able to recoil or spring back
`into shape after bending, stretching, or being compressed.” Oxford On-Line
`Dictionary (http://oxforddictionaries.com/us/definition/american_ english/flexible)
`and (http://oxforddictionaries.com/us/definition/american_ english/resilient).
`These definitions are consistent with the ’914 patent, which discloses that the
`diaphragm withstands being punctured by introducer needle 27 and remain liquid
`tight when the needle is retracted. Ex. 1001 (’914 patent), col. 4, ll. 24-54.
`Claim 1 recites, “a flexible[,] resilient diaphragm which can be penetrated by a
`hypodermic needle, such as a catheter introducer needle” which is consistent with
`the definition of “flexible.” See also Ex. 1001 (’914 patent), claim 34. Thus, the
`diaphragm is “flexible” enough to be penetrated by an introducer needle and
`“resilient” enough to self-seal, once the needle is withdrawn. Therefore, for
`purposes of the petition we apply the following definition:
`
`“Flexible[,] resilient diaphragm” means a thin sheet of material
`forming a partition which is capable of bending or being penetrated by
`a needle easily without breaking and able to spring back into shape
`after being penetrated.
`
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`
`3. Between
`Independent claim 22 recites that the “diaphragm [is] attached between
`[needle attachment] body and a proximal end of said hub proximal to said side
`access port.” In contrast, claim 31 recites that the “diaphragm [is] attached to said
`hub.” One-SD’s construction of “between” (i.e., “in a space that separates the
`needle attachment body and a proximal end of the catheter hub”) does not address
`the issue squarely. Pet. 7 (citing Ex. 1013 (The American Heritage Dictionary,
`pp. 179-80 (3d ed. 1996)). The issue is whether “between” the needle attachment
`body and hub requires the entirety of needle body 20 and the entirety of the hub 14
`be located on opposite sides of diaphragm 34. For example, is diaphragm 34, in
`Figure 3 of the ’914 patent, “between” hub 14 and needle body 20?
`The Specification does not define “between” explicitly or implicitly. The
`Specification does state that the “diaphragm 34 may be removably disposed in the
`hub 14,” or “may be contained in a housing . . . removably attached to the hub 14.”
`Ex. 1001 (’914 patent), col. 4, ll. 35-41 (emphasis removed). However, it is not
`clear if one or both of these diaphragm locations is considered “between” the hub
`and needle body. Likewise, nothing in the prosecution history of record speaks to
`the definition of “between.” Thus, for purposes of the petition, we use the broadest
`common and ordinary meaning of “between” which is “at, into, or across the space
`separating (two objects or regions).” Oxford On-Line Dictionary
`(http://oxforddictionaries. com/us/definition/american_english/between). Under
`this definition, diaphragm 34, in Figure 3 of the ’914 patent, is “between” hub 14
`and needle body 20, as it is at, into, or across the space separating the hub and
`body.
`
`
`12
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`“Between” means “at, into, or across the space separating (two objects
`or regions).”
`
`
`II. ANALYSIS
`We turn now to Petitioner’s asserted grounds of unpatentability and Patent
`Owner’s arguments in its preliminary response to determine whether Petitioner has
`met the threshold standard of 35 U.S.C. § 314(a).
`
`A. Grounds Based on Brimhall
`1. Brimhall (Ex. 1006)—Claim 31
`Brimhall is a U.S. patent which was filed on March 16, 1995 and issued
`December 16, 1997. Brimhall describes a catheter assembly used to place an
`intravenous (“IV”) catheter into a patient. Figure 4 of Brimhall has been colorized
`and labeled and is depicted below.
`
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`Case IPPR2013-002235
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`Patent 55,704,914
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`observeed at notch 42 if the ccatheter is cclear and/oor windoww 27, as nottch 43 allowws
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`The Brimhaall catheterr assemblyy has four pprimary parrts: catheteer 20 (greeen),
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`catheterr hub 21 (red), needlee hub 41 (oorange), annd side porrt 22 with eextension ttube
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`50. In uuse, needlee 40 is advaanced through elastoomeric plugg 29 via neeedle hub 441.
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`Fin 31 tthen is rotaated 90 deggrees relatiive to wingg 25. See EEx. 1006 (BBrimhall),
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`k may be
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`Fig. 3. Needle 400 then is insserted into the patiennt and bloo
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`blood too flow fromm the cannuula of needdle 40 intoo catheter hhub 21. Noote that
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`elastommeric plug 229 preventss blood froom flowingg past catheeter hub 211. Catheteer 20
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`is then iinserted intto the patieent, while simultaneoously holdiing the fin
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`The needlle is retractted
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`prevent needle 40 from advaancing furtther into thhe patient.
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`via needdle hub 41 and removved leavingg catheter
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`Case IPR2013-00235
`Patent 5,704,914
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`the patient. Side port 22 may be used to attach an IV fluid supply. Ex. 1006
`(Brimhall), col. 3, l. 59 – col. 4, l. 44.
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`2. Alleged anticipation of claim 31
`Petitioner, BD, asserts that claim 31 is anticipated by Brimhall. Pet. 27-29.
`Patent Owner, One-SD, argues that Brimhall does not disclose the recited
`“flexible, resilient diaphragm.” Prelim. Resp. 18-19. In its claim chart of
`Brimhall, BD identifies column 3, lines 22 to 25 and lines 52 to 55 as well as
`figures 2 and 4 as disclosing a flexible resilient diaphragm. Pet. 29. These
`passages disclose elastomeric (e.g., silicone) plug 29 located at the proximal end of
`catheter hub 21 to prevent liquid flow past access port 22. Introducer needle 40
`when placed in its operative position, as depicted in figure 2, extends through the
`lumen of catheter hub 21 and through the passageway of catheter 20. It should be
`noted that elastomeric plug 29 through which the needle penetrates is described as
`being filled with silicone gel to prevent fluid leakage. Ex. 1006 (Brimhall), see,
`e.g., Fig. 4 and col. 4, ll. 38-44. BD notes that, while Brimhall does not explicitly
`state that catheter 20 is “flexible,” it does state that “[n]eedle 40 provides column
`strength to catheter 20 as it is advanced into the vein.” Pet. 30; Ex. 1006
`(Brimhall), col. 4, ll. 34-36 (emphasis removed).
`One-SD also argues that Brimhall does not disclose an “introducer needle
`defining at least one fenestration” as recited in claim 31. Prelim. Resp. 19. In its
`claim chart, BD cites the following portions of the Brimhall patent as disclosing an
`introducer needle including at least one fenestration: column 3, line 49 to
`column 4, line 1; column 4, lines 20-28 and lines 39 to 42; and figure 2. Pet. 29.
`The second cited passage explains that introducer needle 40 contains two notches
`(i.e., fenestrations) 42, 43 both of which communicate with the cannula of
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`Patent 5,704,914
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`introducer needle 40 when in operative position (depicted in figure 2). Ex. 1006
`(Brimhall), col. 4, ll. 20-28. At least one notch 43 is located on a central portion of
`needle 40. Ex. 1006 (Brimhall), Fig. 2.
`We find reasonable BD’s contentions that Brimhall discloses each limitation
`of claim 31, including the flexible resilient diaphragm and an introducer needle
`with at least one fenestration. We, thus, conclude that there is a reasonable
`likelihood that BD will prevail on proving anticipation of claim 31 by Brimhall.
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`B. Obviousness Grounds Based on Brimhall Combinations—Claims 22, 23,
`25, 26, 28, and 29
`BD argues that independent claim 22 is very similar to independent
`claim 31, but that notes claim 22 adds “a side access port” which BD argues is
`disclosed in Brimhall as side port 22. Pet. 38-39. In addition, BD points out that
`in claim 31 the “flexible resilient diaphragm” is “attached to said hub,” whereas, in
`claim 22 it is “attached between [the needle attachment] body and a proximal end
`of said hub proximal to said side access port.” Pet. 40. BD relies upon the
`disclosure of Fields for the disclosure of the diaphragm being “between” the body
`and hub. Pet. 41.7
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`1. Fields (Ex. 1002)
`The catheter assembly of Fields has three primary portions: catheter 34
`(green), second connection member 28 (red), and first connection member 12
`(orange). A colorized and labeled version of figure 1 from Fields is included
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`7 Given our initial construction of “between” (i.e., “at, into, or across the space
`separating (two objects or regions)” the plug 29 may be “between” the needle hub
`41 and catheter hub 21.
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`Case IPPR2013-002235
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`Patent 55,704,914
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`below.
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`insertedd in the pattient and bllood flashbback can bee observedd in flashbaack chambber
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`ia needle hhub 36. Ass
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`Inn use, stopp 54 is releaased and n
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`eedle 14 addvanced v
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`30 (yelloww). The neeedle is
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`needle 114 is advannced, it passses througgh septum
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`30, as nneedle 14 contains oppenings 20,, 22, whichh allow bloood flowingg up the
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`needle ccannula to fill the flashback chaamber. Noote that sepptum 32 prrevents the
`r is then
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`blood frrom flowinng past second conneection memmber 28. TThe cathete
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`second connnection
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`insertedd into the ppatient and needle 14
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`memberrs 12, 28 are removedd, leaving catheter 344 attached
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`Fields ddoes not dirrectly disclose a sidee access poort, it does
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`incorporatte Fields II
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`referencce. Ex. 1002 (Fields)), col. 3, ll.. 24-28. AAs depictedd in figure 33, Fields III
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`does dissclose a sidde access pport 44. Exx. 1012 (Fiields II).
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`2. Allleged Obvviousness oof Claims 222, 23, 25,
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`26, 28, annd 29 in vieew
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`off Brimhall and Fieldss
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`a. Claim 222
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`BBD argues tthat Fieldss discloses flexible, reesilient sepptum 32 atttached
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`betweenn first connnector memmber/needlle attachmeent body 1
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`second connector member/hhub 28. Pett. 41; see EEx. 1002 (FFields), Figg. 1. BD
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`further aargues thatt it would hhave been obvious too attach pluug 29 of B
`rimhall
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`Patent 5,704,914
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`between hub 21 and needle hub/needle attachment body 41 as shown in Fields and
`that doing so would still allow plug 29 to be penetrated by needle 40 and still
`prevent fluid spillage. Pet. 42. In essence, BD argues the precise location of the
`diaphragm/plug is merely a matter of design choice.
`One-SD argues that BD has made “no showing that Fields describes or
`suggests a catheter assembly with ‘a flexible[,] resilient diaphragm . . . attached to
`[the] hub to seal a proximal end of said hub lumen in a liquid tight manner for
`preventing a liquid which has been introduced into said hub lumen from said
`catheter . . . from flowing through said diaphragm beyond said hub.’” Prelim.
`Resp. 22. One-SD does not explain what portion(s) of the limitation are not
`disclosed in Fields. Id. We find BD’s contentions that Brimhall and Fields
`disclose the limitations of claim 22, including the flexible, resilient diaphragm, to
`be reasonable. We conclude that there is a reasonable likelihood that BD will
`prevail on proving unpatentability of claim 22 over Brimhall and Fields.
`b. Claim 23
`With respect to claim 23, which further limits claim 22 by reciting that the
`“side access port is formed on said hub,” BD argues that the limitation is disclosed
`in Brimhall as side port 22 is formed on hub 21. Pet. 50; see Ex. 1006 (Brimhall),
`Fig. 1. One-SD does not contest BD’s argument, which we find to be reasonable.
`Prelim. Resp. 17-21. We conclude that there is a reasonable likelihood that BD
`will prevail on proving unpatentability of claim 23 over Brimhall and Fields.
`c. Claims 25 and 26
`With respect to claims 25 and 26, each of which depends from claim 22,
`claim 25 further limits claim 22 by reciting that the “hub is at least partially
`transparent,” whereas claim 26 further limits claim 22 by reciting that the “hub is
`at least partially translucent.” BD argues that Brimhall discloses a transparent or
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`Patent 5,704,914
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`translucent window 27 to observe flash back. Pet. 56; see Ex. 1006 (Brimhall),
`Fig. 1; col 4, ll. 21-23. BD argues that it would have been obvious to move
`flashback window 27 from side port 22 to hub 21, as doing so would not interfere
`with the window’s current purpose of allowing the visualization of blood flow and
`the precise location of the window is merely a matter of design choice. Pet. 55.
`BD also argues that Fields discloses flashback chamber 30, which is part of second
`connector member/hub 28. One-SD does not contest BD’s argument which we
`find to be reasonable. Prelim. Resp. 17-21. We conclude that there is a reasonable
`likelihood that BD will prevail on proving unpatentability of claims 25 and 26 over
`Brimhall and Fields.
`d. Claim 28
`With respect to claim 28, which depends from and further limits claim 22 by
`reciting, “needle attachment body is removably connected to said hub,” BD argues
`the limitation is disclosed in Brimhall. Pet. 57-58. Specifically, BD argues that in
`Brimhall, once catheter 20 is in the patient, needle hub/needle attachment body 41
`is removed from catheter 20 and hub 21. Pet. 58 (citing Ex. 1006 (Brimhall),
`col. 4:35-37). One-SD does not contest BD’s argument, which we find to be
`reasonable. Prelim. Resp. 17-21. We conclude that, there is a reasonable
`likelihood that BD will prevail on proving unpatentability of claim 28 over
`Brimhall and Fields.
`e. Claim 29
`With respect to claim 29, which further limits claim 22 by reciting that the
`“diaphragm is directly attached to said catheter hub,” BD argues that the limitation
`is disclosed in Brimhall. Pet. 59. Specifically, BD notes that in figures 2 and 4,
`diaphragm 29 is located inside and attached to catheter hub 21. Pet. 59. One-SD
`does not contest BD’s argument, which we find to be reasonable. Prelim. Resp.
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`17-21. We conclude that there is a reasonable likelihood that BD will prevail on
`proving unpatentability of claim 29 over Brimhall and Fields.
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`3. Alleged Obviousness of claim 24 over Brimhall, Fields, and
`Enzmann
`Claim 24 further limits claim 22 by reciting, “further comprising a multi-
`position stopcock operatively connected to said access port for selectively closing
`said access port in a liquid tight manner to prevent the flow of a liquid from said
`hub lumen through said access port.” BD alleges that Enzmann discloses stopcock
`75 for selectively closing access ports 76, 77. Pet. 52; (c