Trials@uspto.gov
`571.272.7822
`
`
`
`Paper No. 8
`Entered: November 29, 2017
`
`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 IPR2017-01583
`Patent 8,333,735 B1
`____________
`
`
`Before SCOTT A. DANIELS, MICHAEL L. WOODS, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`WOODS, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`Paper No. 8
`Entered: November 29, 2017
`
`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 IPR2017-01583
`Patent 8,333,735 B1
`____________
`
`
`Before SCOTT A. DANIELS, MICHAEL L. WOODS, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`WOODS, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01583
`Patent 8,333,735 B1
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`
`INTRODUCTION
`I.
`Becton, Dickinson and Company (“Petitioner”) filed a Petition (Paper
`3, “Pet.”) requesting inter partes review of claims 1, 9–11, 18, 19, and 24 of
`U.S. Patent No. 8,333,735 B1 (“the ’735 patent”). Pet. 1. B. Braun
`Melsungen AG (“Patent Owner”) filed a Preliminary Response (Paper 7,
`“Prelim. Resp.”) in response to the Petition, contending that the Petition
`should be denied as to all challenged claims. Prelim. Resp. 1.
`We have authority under 37 C.F.R. § 42.4(a) and 35 U.S.C. § 314,
`which provides that an inter partes review may not be instituted unless the
`information presented in the Petition “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.” Having considered the arguments and the
`evidence presented, for the reasons described below, we do not institute an
`inter partes review of any of the challenged claims.
`A. Related Proceedings
`Petitioner represents that the ’735 patent is at issue in B. Braun
`Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411
`(D. Del.). Pet. 1. Petitioner also represents that petitions for inter partes
`review were filed challenging related U.S. Patent Nos.: 8,328,762;
`8,337,463; 8,540,728; 9,149,626; 8,597,249; 8,460,247; and 9,370,641. Id.
`Below is a chart that associates the inter partes reviews with each patent:
`IPR Number
`Patent Number
`IPR2017-01583
`8,333,735
`IPR2017-01584
`8,540,728
`IPR2017-01585
`8,337,463
`IPR2017-01586
`8,328,762
`
`
`
`2
`
`
`
`IPR2017-01583
`Patent 8,333,735 B1
`
`
`IPR2017-01587
`IPR2017-01588
`IPR2017-01589
`IPR2017-01590
`
`
`
`9,149,626
`8,460,247
`8,597,249
`9,370,641
`
`B. The ’735 Patent (Ex. 1001)
`The ’735 patent, titled “Catheter Insertion Device,” states that an
`intended goal is to prevent “an outflow of blood from the catheter . . . after
`removal of the hollow needle with [a] needle guard element.” Ex. 1001,
`[54], 1:33–36.
`To illustrate an embodiment of the ’735 patent’s catheter insertion
`device, we reproduce Figure 1 of the ’735 patent, below:
`
`
`
`According to the ’735 patent, Figure 1 depicts catheter insertion device 1
`with catheter 4, needle hub 8, to which hollow needle 9 is fixed and which
`needle 9 extends through valve disc 7. Ex. 1001, 2:8–9, 19–22. Between
`needle hub 8 and valve disc 7 is valve actuating element 10 (depicted as 10a
`and 10b), which has a truncated cone-shaped section 10a, which serves to
`open valve disc 7, and a plunger section 10b. Id. at 2:22–26. Also shown is
`needle guard element 13 in the form of a spring clip. Id. at 2:28–32. Needle
`guard element 13 serves to cover needle tip 9a upon withdrawal of needle 9
`from the catheter hub, thereby “completely protecting and blocking it,” as
`shown in Figure 2. See id. at 2:33–41.
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`To illustrate the removal of needle 9 from catheter hub 2, we
`reproduce Figure 2, below:
`
`
`
`Figure 2 depicts the catheter insertion device with needle 9 removed from
`catheter hub 2. Ex. 1001, 1:57–58, 2:33–34. As shown above, needle guard
`element/spring clip 13 is removed from the catheter hub along with needle 9,
`causing the spring clip’s spring arms 13a, 13b to cover the needle’s tip. Id.
`at 2:38–41. Figure 2 also depicts valve disc 7—which is elastic—as closing
`the through-hole from which needle 9 is removed to prevent blood flow
`from exiting the catheter. Id. at 2:41–44.
`
`
`C. Illustrative Claim
`Of the challenged claims, claims 1, 10, and 18 are independent, with
`claim 9 depending from claim 1, claim 11 depending from claim 10, and
`claims 19 and 24 depending from claim 18. Id. at 5:1–8:28. Claim 1 is
`illustrative of the subject matter at issue and is reproduced below, with
`emphasis added to a particular limitation addressed in our Decision:
`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 configured to obstruct fluid flow comprising a wall
`surface comprising a slit positioned inside the interior cavity of
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`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.
`
`Id. at 5:2–5:27 (emphasis added).
`
`
`D. References Relied Upon
`The Petitioner relies in relevant part on the following references (Pet.
`
`3):
`
`Reference
`Name
`US 6,117,108, issued Sept. 12, 2000
`Woehr
`Tauschinski US 4,387,879, issued June 14, 1983
`Arnett
`US 5,817,069, issued Oct. 6, 1998
`Van Heugten US 5,053,014, issued Oct. 1, 1991
`Pike
`US 5,954,698, issued Sept. 21, 1999
`Luther
`US 4,842,591, issued June 27, 1989
`Greene
`US 6,221,047 B1, issued Apr. 24, 2001
`
`Ex. No.
`Ex. 1003
`Ex. 1004
`Ex. 1005
`Ex. 1006
`Ex. 1007
`Ex. 1008
`Ex. 1013
`
`E. Alleged Grounds of Unpatentability
`Petitioner contends that claims 1, 9–11, 18, 19, and 24 of the ’735
`patent are unpatentable under the following grounds (Pet. 3):
`
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`References
`Woehr, Tauschinski, and Arnett
`Van Heugten and Arnett
`Pike and Luther
`Van Heugten, Arnett, and Greene
`
`Basis
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`
`Claim(s)
`1, 9–11, 18, 19, and 24
`1, 9–11, 18, 19, 24
`10, 11, 18, 19, 24
`9
`
`Petitioner also relies on the declaration testimony of Jack Griffis, III
`(Ex. 1002) in support of its Petition. Patent Owner relies on the declaration
`testimony of Richard Meyst (Ex. 2001) in support of its Preliminary
`Response.
`
`
`II. ANALYSIS
`A. Claim Construction
`As a first step in our analysis, we determine the meaning of the claims
`using the “broadest reasonable construction in light of the specification of
`the patent in which [they] appear.” 37 C.F.R. § 42.100(b); Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of
`the broadest reasonable interpretation approach). Under that standard, claim
`terms are generally given their ordinary and customary meaning, as would
`be understood by one of ordinary skill in the art in the context of the entire
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007).
`Although Petitioner and Patent Owner disagree about the
`interpretation of the claim term “needle protective device” (Compare Pet.
`7─9, with Prelim. Resp. 8─9), we determine that no term requires express
`construction for the purposes of this Decision. See Wellman, Inc. v.
`Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms
`
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`need only be construed ‘to the extent necessary to resolve the controversy’”)
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999)). Here, regardless of the interpretation of the claim term
`“needle protective device,” we determine that the information presented in
`the Petition fails to show that there is a reasonable likelihood that Petitioner
`would prevail with respect to at least 1 of the claims challenged in the
`Petition.
`
`
`B. Principles of Law
`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations, including (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art; (3)
`the level of skill in the art; and (4) objective evidence of nonobviousness,
`i.e., secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–
`18 (1966).
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016). This burden never shifts to Patent Owner. Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`
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`C. Level of Ordinary Skill in the Art
`In determining whether an invention would have been obvious at the
`time it was made, we consider the level of ordinary skill in the pertinent art
`at the time of the invention. Graham, 383 U.S. at 17.
`Petitioner relies upon the declaration of Mr. Griffis (Ex. 1002) and
`contends that a person of ordinary skill in the art (“POSITA”) would have
`been either “a medical practitioner with experience using vascular access
`devices and with training, experience and/or familiarity applying principles
`of engineering to the design, development, and/or testing of vascular access
`devices,” or “an engineer having at least a bachelor of science degree and
`with several years of experience in the design, development, and/or testing
`of vascular access devices and their clinical use; a higher level of education
`could reduce the number of years of experience required.” Pet. 6 (citing Ex.
`1002 ¶¶ 28–30).
`Patent Owner, on the other hand, relies upon the declaration of Mr.
`Meyst (Ex. 2001) and contends that a POSITA would have had “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.” Prelim. Resp. 4 (citing Ex.
`2001 ¶¶ 26–28).
`Based on our review of the ’735 patent, the types of problems and
`solutions described in the ’735 patent and applied prior art, and the
`testimony of Mr. Griffis and Mr. Meyst, we determine that a POSITA would
`be either a medical practitioner (e.g., a nurse or doctor) having at least some
`experience with vascular catheter devices, or a person with a technical
`
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`degree (e.g., associate’s degree in engineering or physics) and having at least
`some experience with vascular catheter devices. Further, the applied prior
`art reflects the appropriate level of skill at the time of the claimed invention,
`for example, Woehr reflects that the field involves catheters and their use by
`skilled health-care workers. See Okajima v. Bourdeau, 261 F.3d 1350, 1355
`(Fed. Cir. 2001); Ex. 1003, 1:7–11, 1:60–2
`
`D. Woehr, Tauschinski, and Arnett
`Petitioner contends that claims 1, 9–11, 18, 19, and 24 are
`unpatentable over Woehr, Tauschinski, and Arnett. Pet. 3.
`
`1. Woehr (Ex. 1003)
`Woehr is a U.S. patent titled “Spring Clip Safety IV Catheter” and it
`discloses a “catheter in which the needle tip is automatically covered after
`needle withdrawal to prevent the health-care worker from making accidental
`contact with the needle tip.” Ex. 1003, [54], 1:7–11. To illustrate an
`embodiment of Woehr’s catheter, we reproduce Figure 1A, below:
`
`Figure 1A depicts catheter 10 including needle hub 12, needle 16 with
`needle tip 18, catheter hub 26, and needle guard 40 in the form of a unitary
`
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`spring clip. Id. at 4:8–28, 50–51. As needle 16 is withdrawn from a patient,
`needle guard 40 “automatically snaps into a retracted position” to block
`needle tip 18 to prevent accidental contact to the health care practitioner. Id.
`at 4:43–49.
`
`Tauschinski (Ex. 1004)
`2.
`Tauschinski is a U.S. patent titled “Self-Sealing Connector for Use
`with Plastic Cannulas and Vessel Catheters” and it discloses a connector that
`will close automatically when a corresponding catheter is pulled from the
`connector, thereby “prevent[ing] an emergence of blood or an ingress of air”
`through the connector. See Ex. 1004, [54], 2:7–31. To illustrate the
`disclosed connector, we reproduce Tauschinski’s Figures 2 and 3, below:
`
`
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`10
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`According to Tauschinski, Figures 2 and 3 depict a connector with a slit
`sealing disc. See id. at 2:62–68. In particular, these figures depict member
`10 slidable within hollow-conical portion 2 and disc 3 provided with central
`slit 8. See id. at 3:17–25. Figure 2 depicts disc 3 as closed. Figure 3 depicts
`member 10 advanced downward within slit 8 of disc 3 such that slit 8 is
`opened. See id. at 3:29–36.
`
`Arnett (Ex. 1005)
`3.
`Arnett is a U.S. patent titled “Valve Assembly” and discloses a “valve
`assembly having a body, an end cap, a resilient septum, and an actuator.”
`Ex. 1005, [54], [57]. Arnett discloses that its inventive valve assembly
`provides a “superior seal” to prevent leakage. Id. at 1:12–17. Arnett
`discloses that its “actuator moves the shoulder surface of the septum away
`from the septum shoulder of the body to allow fluid to flow through the
`body fluid passageway, the chamber fluid passageways and the end cap fluid
`passageway.” Id. at 1:51–55. To illustrate an embodiment of Arnett’s
`invention—which Petitioner itself relies upon (Pet. 18–19)—we reproduce
`Figure 11 of Arnett, below:
`
`
`
`11
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`Patent 8,333,735 B1
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`Arnett describes Figure 11 as depicting a catheter and valve assembly in the
`open position and when a needle is not used. See id. at 2:29–36; see also id.
`at 5:51–58 (describing a different but similar embodiment of Figure 6
`“[w]hen the valve assembly 10 is used in a needleless access system . . .”).
`In particular, Figure 11 depicts valve assembly 10 including septum 216 and
`actuator 220. Septum 216 “is made of a resilient, compressible elastomeric
`material . . . that can be compressed or deformed numerous times without
`losing its original shape.” Id. at 7:15–18. In operation, when actuator 220 is
`pressed against septum 216, a seal between shoulder surface 284 and septum
`shoulder 246 breaks, thus allowing fluid to flow from luer 140 through fluid
`passageway 306 and through fluid passageways 290. See id. at 8:26–44.
`Assembly 10 can be resealed by removing luer 140 from body 212, which
`removes the force applied by actuator 220 onto septum 216, “thereby
`causing septum 216 to regain its original shape to form a seal between the
`shoulder surface 284 and the septum shoulder 246.” See id. at 8:45–50.
`To better illustrate Arnett’s actuator 220, we reproduce Figure 12,
`below:
`
`
`As described by Arnett, Figure 12 depicts actuator 220 including septum
`contact surface 312, an opposed fitting contact surface 314, and fluid
`passageway 306. Id. at 7:29–39. As discussed above in connection with
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`Figure 11, fluid passageway 306 allows fluid to flow around septum 216 and
`through fluid passageways 290. See id. at Fig. 11, 8:41–44.
`
`Petitioner’s Challenge
`4.
`In challenging the claims, Petitioner submits that Woehr discloses a
`“catheter insertion device” comprising a “catheter hub” (or “first hub”),
`“needle,” and “needle protective device.” See Pet. 11–13, 21–23
`(challenging independent claim 1); see also id. at 24–28 (challenging
`independent claim 10); id. at 29–32 (challenging independent claim 18). To
`illustrate these findings, Petitioner submits several annotated Figures,
`including several annotated figures of Woehr’s Figure 10A (id. at 12, 13,
`22), two of which we reproduce, below:
`
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`According to Petitioner, and as shown in Figure 10A, Woehr discloses a
`“catheter insertion device” comprising the claimed “catheter hub” 26,
`“needle” 16, and “needle protection device” 120. Id. at 11–13, 21–23.
`In addressing the claimed “valve configured to obstruct fluid flow,”
`Petitioner relies on Tauschinski and reasons that it would have been obvious
`to modify Woehr to include Tauschinski’s valve. See id. at 13–16 (citations
`omitted). In relying on Tauschinski, Petitioner submits an annotated version
`of Tauschinski’s Figure 2 (id. at 15), which we reproduce below:
`
`
`As shown in Figure 2, Petitioner asserts that Tauschinski discloses valve 3
`with slit 8 configured to obstruct fluid flow through catheter hub 1. Id. at 14
`(citing in-part Ex. 1004, 2:7–19). Petitioner reasons that it would have been
`obvious to modify Woehr “by adding protective elements, such as a valve to
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`prevent the emergence of blood,” as disclosed by Tauschinski. Id. at 15–16
`(citing in-part Ex. 1002 ¶¶ 71–73).
`In addressing the claimed “valve actuating element comprising a nose
`section having a tapered end . . . and at least two plunger elements extending
`proximally of the nose section and having a gap therebetween,” Petitioner
`relies on both Tauschinski and Arnett. Id. at 16–21.
`To address the claimed “valve actuating element comprising a nose
`section having a tapered end,” Petitioner submits annotated versions of
`Tauschinski’s Figures 2 and 3 (id. at 18), which we reproduce below:
`
`
`
`According to Petitioner, and as shown in the above Figures 2 and 3,
`Tauschinski discloses valve actuating element 10 with a nose section having
`a tapered end, slidingly disposed in catheter hub 1, and configured to actuate
`valve 3 to open slit 8. Id. at 17 (citing Ex. 1004, 3:21–36).
`To address the claimed “valve actuating element comprising . . . at
`least two plunger elements extending proximally of the nose section and
`having a gap therebetween to permit fluid flow to flow therethrough,”
`Petitioner relies on Arnett and submits annotated versions of Arnett’s
`Figures 11 and 12 (id. at 19), which we reproduce below:
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`According to Petitioner, Figure 11 (above-left) depicts valve actuating
`element 220, and as shown in Figure 12 (above-right), valve actuating
`element 220 that has two plungers 314 and gap 306 “therebetween to permit
`fluid flow to flow therethrough.” Pet. 19 (citing: Ex. 1005, 7:34–36; Ex.
`1002 ¶¶ 74–81).
`In combining Woehr with Tauschinski and Arnett to arrive at the
`claimed “valve actuating element,” Petitioner reasons that it would have
`been obvious to use Tauschinski’s valve actuator, including its tapered nose,
`in order to actuate Tauschinski’s valve, and that it would have been obvious
`to modify Tauschinski’s actuator “to contain two plunger elements . . . to
`open a valve as described in Arnett.” Id. at 20. In particular, we reproduce
`Petitioner’s reasoning for modifying Tauschinski’s valve actuator to include
`Arnett’s two “plunger elements . . . having a gap therebetween,” below:
` Further, it would have been obvious to modify the
`actuator disclosed in Tauschinski to contain two plunger
`elements on the proximal end of the valve actuating element that
`are pushed by an external force to open a valve as described in
`Arnett. Arnett discloses a safety catheter device with a valve,
`actuator, and needle protection. Both Tauschinski and Arnett
`disclose valves and valve actuators with a central passageway
`that can be used with catheter devices, and both recognize the
`need to include such valves and valve actuators to prevent
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`leakage. (Ex.1002, Decl. ¶¶71-81.) Adding another passageway
`at the proximal end of the actuator is a known design choice in
`IV catheter blood control actuators that still allows the actuator
`to transfer a distally directed force to open the valve slit. (Id.)
`Further, adding a gap in the actuator is one of a finite number of
`predictable solutions for creating space to accommodate the
`valve, actuator, and spring clip in the catheter hub, while also
`allowing a male luer to push on the actuator and permit fluid
`flow in the device. (Id.) Thus, it would have been obvious to a
`POSA to modify the valve actuator of Tauschinski to add
`plungers as described in Arnett, and to include that actuator in
`the spring clip safety IV catheter of Woehr ’108. (Id.)
`Pet. 20–21 (emphases added). In summary, Petitioner reasons that a person
`having ordinary skill in the art would have modified Tauschinski’s actuator
`to include Arnett’s “plungers” and “gap” as a matter of simple “design
`choice,” because it is “one of a finite number of predictable solutions for
`creating space to accommodate the valve, actuator, and spring clip in the
`catheter hub.” Id.
`
`
`Patent Owner’s Argument
`5.
`Patent Owner argues that Petitioner’s reason for adding Arnett’s
`“plunger elements . . . having a gap therebetween” “is based on an illogical
`analysis and mere conclusory statements.” See Prelim. Resp. 48. In support
`of this argument, Patent Owner asserts that a “POSITA would have no
`reason to, and would not want to, modify Tauschinski’s existing actuator to
`include two plunger elements based on Arnett.” Id. at 48–49. Patent Owner
`points out that “the mode of operation of the valve actuating element and
`septum of Arnett is completely different from the valve actuating element
`and ‘disc consisting of elastic material and having a central slit’ of
`Tauschinski.” Id. at 51.
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`We agree.
`
`Analysis
`6.
`We are not persuaded that a person having ordinary skill in the art
`would have looked to Arnett to modify Tauschinski’s actuator to include
`Arnett’s “plunger elements . . . having a gap therebetween” as a matter of
`simple “design choice” “for creating space” (Pet. 20–21).
`“It is impermissible within the framework of section 103 to pick and
`choose from any one reference only so much of it as will support a given
`position, to the exclusion of other parts necessary to the full appreciation of
`what such reference fairly suggests.” In re Hedges, 783 F.2d 1038, 1041
`(Fed. Cir. 1986) (citation and inner quotes omitted). In the present case,
`Petitioner’s reasoning “picks and chooses” the structure of Arnett’s actuator
`220 and “gap” 306 to the exclusion of Arnett’s extensive disclosure
`regarding the purpose and operation of these components, an understanding
`of which is “necessary to the full appreciation of what [Arnett] fairly
`suggests” (id.).
`As pointed out correctly by Patent Owner (see Prelim. Resp. 48–49),
`and as discussed supra, Arnett’s “at least two plunger elements . . . having a
`gap [306] therebetween” function to direct fluid around Arnett’s “valve”
`(septum 216) (see Ex. 1005, 8:26–44). To reiterate Arnett’s operation, we
`reproduce a partial view of Arnett’s Figure 11, below:
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`The portion of Figure 11 depicts the assembly in an open position. See Ex.
`1005, 8:41–43. As shown in Figure 11, and denoted by arrows, when
`Arnett’s actuator 220 presses against septum 216, a seal between shoulder
`surface 284 and septum shoulder 246 breaks, thus allowing fluid to flow
`through fluid passageway 306 and through fluid passageways 290. See id.
`(“fluid is free to flow from the luer 140 through the fluid passageway 306 of
`the actuator 220 to the chamber fluid passageways 290”).
`As explained above, Petitioner’s modification proposes to use
`Tauschinski’s valve. See Pet. 20–21 (citing Ex. 1002 ¶¶ 71–81).
`Tauschinski’s valve 3, however, operates very differently from Arnett’s
`septum 216, by directing fluid through, and not around, Tauschinski’s valve.
`See id. Because fluid is not directed around Tauschinski’s valve, and
`Petitioner has not provided a persuasive reason why such fluid flow would
`be desirable for Tauschinski’s valve, we are not persuaded that a person
`having ordinary skill in the art would have looked to Arnett to modify
`Tauschinski’s actuator to include Arnett’s “plunger elements . . . having a
`gap [306] therebetween,” as Petitioner proposes, and simply as a matter of
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`design choice to “create space.” Id. Rather, we find that Petitioner’s
`reasoning selectively ignores Arnett’s general disclosure regarding the
`operation of Arnett’s “gap” 306 and fails to give full appreciation to what
`Arnett’s “gap” fairly suggests to a person having ordinary skill in the art. In
`re Hedges, 783 F.2d at 1041.
`Moreover, independent claims 1 and 18 do not simply recite a “gap,”
`but recite a “gap . . . to permit fluid flow to flow therethrough” or
`“therebetween.” Ex. 1001, 5:2–27, 6:37–64. Petitioner fails to explain how,
`under the proposed modification, Arnett’s “gap” 306 would “permit fluid
`flow to flow therethrough,” when the proposed modification utilizes
`Tauschinski’s valve, which itself does not direct fluid around the valve. See
`Pet. 18–21 (citing Ex. 1002 ¶¶ 71–81; see also Ex. 1002 ¶ 79 (citing Ex.
`1005, 7:34–36)). In other words, although we agree with Petitioner that
`Arnett’s fluid passageway 306—the claimed “gap”—permits fluid to flow
`therethrough (see Pet. 19), as discussed above, fluid flows through
`passageway 306 only to the extent that passageway 306 is directing fluid to
`flow around Arnett’s “valve” (septum 216) and through Arnett’s
`passageways 290. See Ex. 1005, 8:26–44, Fig. 11. Accordingly, we are not
`persuaded that the proposed combination would result in a “gap . . . to
`permit fluid flow to flow therethrough” or “therebetween,” as further
`required by independent claims 1 and 18. Ex. 1001, 5:2–27, 6:37–64.
`Based on the record before us, we determine that Petitioner has not
`established a reasonable likelihood of prevailing on its contention that the
`combined teachings of Woehr, Tauschinski, and Arnett render obvious
`claims 1, 9–11, 18, 19, and 24.
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`E. Van Heugten and Arnett
`Petitioner contends that claims 1, 9–11, 18, 19, and 24 are
`unpatentable over Van Heugten and Arnett. Pet. 3.
`
`Van Heugten (Ex. 1006)
`1.
`Van Heugten is a U.S. Patent titled “Catheter with Controlled Valve.”
`Ex. 1006, [54]. Van Heugten discloses a “catheter hub assembly . . .
`wherein the assembly contains a membrane useful in preventing backflow of
`blood.” Id. at [57]. To illustrate Van Heugten’s catheter assembly, we
`reproduce Figure 2, below:
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`Figure 2 depicts a cross-sectional view of Van Heugten’s catheter assembly
`10. Id. at 2:6–10, 19─21. In particular, Figure 2 illustrates catheter
`assembly 10 with catheter 50 and needle 24, which needle guard 30 covers
`upon retraction of needle 24 to prevent inadvertent needle injury to the user
`or others. See id. at 2:36–39, 3:34–58. Catheter assembly 10 also includes
`valve membrane 110, which is illustrated in Figures 4a and 4b, which we
`also reproduce, below:
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`As disclosed in Van Heugten, Figures 4a and 4b further show membrane
`assembly 100 comprising a one-directional valve membrane 110. Id. at
`3:59–64. Figure 4a (above-left) depicts membrane 110 as being “punctured”
`by needle 24 (id. at 3:59–4:3), while Figure 4b (above-right) depicts needle
`24 removed, where upon “removal from the catheter hub 52, the valve
`membrane closes” (id. at 4:6–9). Valve member 110 is “generally
`configured as a ‘duck bill’ valve or a valve of similar configuration and
`smoothly allows removal of . . . needle 24[, so that upon] removal of the
`needle 24 from the catheter 50, the valve membrane unidirectionally closes
`so that blood will not flow into flash chamber 26.” Id. at 4:23–30.
`
`Petitioner’s Challenge
`2.
`Petitioner asserts that Van Heugten discloses a “catheter insertion
`device” comprising the claimed “catheter hub” or “first hub,” “needle,”
`“valve,” and “needle protective device.” Pet. 35–39, 42 (independent claim
`1); id. at 44–45, 47–48 (independent claim 10); id. at 49–51, 52–53
`(independent claim 18). In support of these findings, Petitioner submits
`annotated versions of Van Heugten’s Figure 2 (id. at 37, 42), which we
`reproduce, below:
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`According to Petitioner, and as shown above, Figure 2 depicts Van
`Heugten’s “catheter hub” 52, “needle” 24, and “needle protective device”
`30. Id. at 35, 36, 42.
`Petitioner also submits an annotated version of Van Heugten’s Figure
`3 (id. at 38), which we also reproduce, below:
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`According to Petitioner, and as shown in Figure 3, Van Heugten also
`discloses the claimed “valve” 100, 110. See id. at 38–39 (“a POSA would
`have understood Van Heugten to disclose the valve membrane 110 having
`one or more slits”) (citing Ex. 1002 ¶¶ 118–121).
`In addressing the claimed “valve actuating element,” Petitioner relies
`on a combination of Van Heugten and Arnett. Id. at 39. In particular,
`Petitioner relies on Van Heugten for disclosing a “valve actuating element
`comprising a nose section having a tapered end” 122 for “pushing the valve
`to open the slit of the valve,” and submits an annotated version of Van
`Heugten’s Figure 4c (id. at 40), which we reproduce, below:
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`According to Petitioner, Figure 4c depicts “valve actuating element” 120
`comprising a nose section with a tapered end 122. Pet. 40 (citing Ex. 1006,
`4:31–36, 4:43–49).
`To address the claimed “valve actuating element comprising . . . at
`least two plunger elements . . . having a gap therebetween,” and as with the
`previous ground, Petitioner relies on Arnett’s actuator 220 with “two
`plungers with a gap between these elements.” Id. at 41. Petitioner reasons
`that it would have been obvious to modify Van Heugten’s “valve actuator”
`120 to include Arnett’s “plungers with a gap,” as follows:
`It would have been obvious for a POSA to combine the
`catheter insertion device of Van Heugten with the valve actuating
`elements disclosed in Van Heugten and Arnett. Both Van
`Heugten and Arnett disclose catheter insertion assemblies with a
`valve, an actuator, and needle protection. It would have been
`obvious to a POSA to modify Van Heugten’s valve actuating
`element to put two plunger elements on the proximal end that are
`pushed by an external force to open a valve as described in
`Arnett. Adding structure at the end of the actuator to create two
`plungers with a gap between these elements was a known
`actuator configuration. Further, it had a known advantage to
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`allow fluid to flow from an external infusion set. A POSA would
`have found it obvious to improve Van Heugten by adding an
`actuator based on the known technique disclosed in Arnett to
`improve a similar catheter insertion device actuator that could
`be used for its intended purpose of actuating the valve and
`promoting fluid flow. (Ex.1002, Decl. ¶¶122-126.)
`Pet. 41 (emphases added). In summary, Petitioner proposes to modify Van
`Heugten’s actuator because Arnett’s “two plungers with a gap between these
`elements was a known configuration . . . [and] it had a known advantage to
`allow flu
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