Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`Paper No. 8
`Entered: December 15, 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 IPR2017-01585
`Patent 8,337,463 B2
`____________
`
`
`Before SCOTT A. DANIELS, MICHAEL L. WOODS, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`DANIELS, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`Paper No. 8
`Entered: December 15, 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 IPR2017-01585
`Patent 8,337,463 B2
`____________
`
`
`Before SCOTT A. DANIELS, MICHAEL L. WOODS, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`DANIELS, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01585
`Patent 8,337,463 B2
`
`A. Background
`
`I.
`
`INTRODUCTION
`
`Becton, Dickinson and Company (“Petitioner”) filed a Petition
`
`requesting inter partes review of claims 1, 2, 10, 12, 25, and 28 of U.S.
`
`Patent No. 8,337,463 B2 (“the ’463 patent”). Paper 3, (“Pet.”). B. Braun
`
`Melsungen AG (“Patent Owner”) filed a Preliminary Response contending
`
`that the Petition should be denied as to all challenged claims. Paper 7,
`
`(“Prelim. Resp.”).
`
`We have jurisdiction under 37 C.F.R. § 42.4(a) and 35 U.S.C. § 314,
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`which provides that an inter partes review may not be instituted unless the
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`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
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`claims challenged in the petition.” Having considered the arguments and the
`
`evidence presented, for the reasons described below, we do not institute an
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`inter partes review of any of the challenged claims.
`
`B. Additional Proceedings
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`Petitioner represents that the ’463 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 also filed challenging related patents US. Patent Nos.:
`
`8,328,762; 8,333,735; 8,540,728; 9,149,626; 8,597,249; 8,460,247; and
`
`
`
`
`2
`
`
`
`IPR2017-01585
`Patent 8,337,463 B2
`
`9,370,641. Id. Below is a chart that associates the inter partes reviews with
`
`each patent:
`
`
`
`IPR Number
`
`Patent Number
`
`IPR2017-01583
`
`IPR2017-01584
`
`IPR2017-01585
`
`IPR2017-01586
`
`IPR2017-01587
`
`IPR2017-01588
`
`IPR2017-01589
`
`IPR2017-01590
`
`8,333,735
`
`8,540,728
`
`8,337,463
`
`8,328,762
`
`9,149,626
`
`8,460,247
`
`8,597,249
`
`9,370,641
`
`
`
`C. The ’463 Patent (Ex. 1001)
`
`The ’463 patent, titled “Catheter Insertion Device,” purports to
`
`prevent “an outflow of blood from the catheter . . . after removal of the
`
`hollow needle with [a] needle guard element.” Ex. 1001, 1:33–34. Figure 1
`
`of the ’463 patent’s catheter insertion device is reproduced below:
`
`According to the ’463 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 passes through valve disc 7 and extends through catheter 4.
`
`
`
`3
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`
`
`IPR2017-01585
`Patent 8,337,463 B2
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`Ex. 1001, 2:8–9, 19–22. Between needle hub 8 and valve disc 7 is valve
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`actuating element 10, which has a truncated cone-shaped section 10a, which
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`serves to open valve disc 7. Id. at 2:20–24. Also shown is needle guard
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`element 13 in the form of a spring clip. Id. at 2:27–29. Needle guard
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`element 13 serves to cover needle tip 9a upon withdrawal of needle 9 from
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`the catheter hub, thereby “completely protecting and blocking it,” as shown
`
`in Figure 2. See id. at 2:31–39.
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`To illustrate the removal of needle 9 from catheter hub 2, we
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`reproduce Figure 2, below:
`
`
`
`Figure 2, above, depicts the catheter insertion device with needle 9
`
`removed from catheter hub 2. Ex. 1001, 1:57–58, 2:33–38. As shown,
`
`when needle guard element/spring clip 13 is removed from the catheter hub
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`along with needle 9, the spring clip’s spring arms 13a, 13b cover the
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`needle’s tip. Id. at 2:38–41. Figure 2 depicts also valve disc 7—which is
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`elastic—as closing the through-hole from which needle 9 is removed to
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`prevent blood flow from exiting the catheter. Id. at 2:41–44.
`
`D. Illustrative Claim
`
`Of the challenged claims, claims 1, 10, and 25 are independent. Each
`
`of dependent claims 2, 12, and 28 depend directly from respective
`
`independent claims 1, 10, and 25. Claim 1 illustrates the claimed subject
`
`matter and is reproduced below:
`
`4
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`
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`IPR2017-01585
`Patent 8,337,463 B2
`
`
`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;
`
`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.
`
`Ex. 1001, 5:2–30 (emphasis added).
`
`E. The Alleged Grounds of Unpatentability
`
`Petitioner contends that the challenged claims are unpatentable on the
`
`following specific grounds.1
`
`
`1 Petitioner supports its challenge with a Declaration of Jack Griffis, III, (Ex.
`1002), and in its Preliminary Response, Patent Owner relies upon a
`Declaration of Richard Meyst (Ex. 2001). See infra.
`
`5
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`
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`IPR2017-01585
`Patent 8,337,463 B2
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`
`References
`Woehr,2 Tauschinski,3 and Arnett4
`Van Heugten5 and Arnett
`
`
`Basis Claims Challenged
`§ 103 1, 2, 10, 12, 25, and 28
`§ 103 1, 2, 10, 12, 25, and 28
`
`II. CLAIM CONSTRUCTION
`
`A. Legal Standard
`
`“A claim in an unexpired patent that will not expire before a final
`
`written decision is issued shall be given its broadest reasonable construction
`
`in light of the specification of the patent in which it appears.” 37 C.F.R.
`
`§ 42.100(b). When applying that standard, we interpret the claim language
`
`as it would be understood by one of ordinary skill in the art in light of the
`
`specification. In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir.
`
`2010). 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. See In re Translogic Tech.,
`
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (“The ordinary and customary
`
`meaning ‘is the meaning that the term would have to a person of ordinary
`
`skill in the art in question.’”). Only terms which are in controversy need to
`
`be construed, and then only to the extent necessary to resolve the
`
`controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`
`(Fed. Cir. 1999).
`
`B. Needle Protective Device
`
`Although Petitioner and Patent Owner disagree about the
`
`interpretation of the claimed term “needle protective device” (Compare Pet.
`
`
`2 (Ex. 1003) US 6,117,108, issued Sept. 12, 2000.
`3 (Ex. 1004) US 4,387,879, issued June 14, 1983.
`4 (Ex. 1005) US 5,817,069, issued Oct. 6, 1998.
`5 (Ex. 1006) US 5,053,014, issued Oct. 1, 1991.
`
`6
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`IPR2017-01585
`Patent 8,337,463 B2
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`7–8, with Prelim. Resp. 6–8), we determine that no term requires express
`
`construction for the purposes of this Decision. See Wellman, Inc. v.
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`Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms
`
`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 claimed 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 one of the claims challenged in the
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`Petition.
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`III. ANALYSIS
`
`A. Principles of Law
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`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
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`between the subject matter sought to be patented and the prior art are such
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`that the subject matter as a whole would have been obvious at the time the
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`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
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`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,
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`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
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`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`
`7
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`
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`IPR2017-01585
`Patent 8,337,463 B2
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`Cir. 2016). This burden never shifts to Patent Owner. Dynamic Drinkware,
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`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`B. Level of Ordinary Skill in the Art
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`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. Jack Griffis (Ex. 1002)
`
`and contends that a person of ordinary skill in the art (“POSITA”) would
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`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 ¶ 30).
`
`Patent Owner relies upon the declaration of Mr. Richard 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 ’463 patent, the types of problems and
`
`solutions described in the ’463 patent and applied prior art, and the
`
`testimony of Mr. Griffis and Mr. Meyst, we determine that a POSITA would
`
`8
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`IPR2017-01585
`Patent 8,337,463 B2
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`include a medical practitioner (e.g., a nurse or doctor) having at least some
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`experience with vascular catheter devices, or a person with a technical
`
`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.
`
`See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`
`C. Alleged Obviousness over Woehr, Tauschinski, and Arnett
`
`Petitioner contends that claims 1, 2, 10, 12, 25, and 28 are
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`unpatentable over Woehr, Tauschinski, and Arnett. Pet. 3, 10–40.
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`1. Woehr (Ex. 1003)
`
`Woehr is a U.S. Patent titled “Spring Clip Safety IV Catheter” and
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`discloses a “catheter in which the needle tip is automatically covered after
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`needle withdrawal to prevent the health-care worker from making accidental
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`contact with the needle tip.” Ex. 1003, [54], 1:8–11. Figure 1A illustrating
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`Woehr’s catheter is reproduced below:
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`Woehr describes Figure 1A as depicting catheter 10 including needle hub
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`12, needle 16 with needle tip 18, catheter hub 26, and needle guard 40 in the
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`form of a unitary spring clip. Id. at 4:8–28, 50–51. Functionally speaking,
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`as needle 16 is withdrawn from a patient, needle guard 40 “automatically
`
`
`
`9
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`IPR2017-01585
`Patent 8,337,463 B2
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`snaps into a retracted position” to block needle tip 18 to prevent accidental
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`contact to the health care practitioner. Id. at 4:43–49.
`
`2. Tauschinski (Ex. 1004)
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`Tauschinski is a U.S. Patent titled “Self-Sealing Connector for Use
`
`with Plastic Cannulas and Vessel Catheters” and discloses a connector that
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`will close automatically when a corresponding catheter is pulled from the
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`connector, thereby “prevent[ing] an emergence of blood or an ingress of air”
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`through the connector. See Ex. 1004, [54], 2:7–29. To illustrate the
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`disclosed connector, we reproduce Tauschinski’s Figures 2 and 3, below:
`
`
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`Tauschinski’s Figures 2 and 3 depict a connector with a slit sealing disc. See
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`id. at 2:62–68. In particular, these figures depict member 10 slidable within
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`hollow-conical portion 2 and disc 3 provided with central slit 8. See id. at
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`3:17–25. Figure 2 depicts disc 3 as closed, with Figure 3 depicting member
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`10
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`
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`IPR2017-01585
`Patent 8,337,463 B2
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`10 advanced downward and within slit 8 of disc 3 to open the slit. See id. at
`
`3:29–36.
`
`3. Arnett (Ex. 1005)
`
`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 alleges that its inventive valve assembly
`
`provides a “superior seal” to prevent leakage. Id. at 1:12–17. Arnett
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`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:
`
`Figure 11 depicts 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
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`assembly 10 is used in a needleless access system . . .”).
`
`
`
`11
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`IPR2017-01585
`Patent 8,337,463 B2
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`
`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
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`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
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`id. at 8:26–44. Assembly 10 can be resealed by removing luer 140 from
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`body 212, which removes the force applied by actuator 220 onto septum
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`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:
`
`
`
`Arnett’s 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 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.
`
`12
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`IPR2017-01585
`Patent 8,337,463 B2
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`
`4. Petitioner’s Challenge to Claims 1, 2, 10, 12, 25, and
`28
`In challenging the claims, Petitioner submits that Woehr discloses a
`
`“catheter insertion device” comprising a “catheter hub” (or “first hub”),
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`“needle,” and “needle protective device.” See Pet. 13–15, 25–28
`
`(challenging independent claim 1); see also id. at 28–29 (challenging
`
`independent claim 10); see also id. at 34 (challenging independent claim 18).
`
`To illustrate these findings, Petitioner submits several annotated Figures,
`
`including several annotated figures of Woehr’s Figure 10A (id. at 14, 15,
`
`26), two of which we reproduce, below:
`
`
`
`
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`According to Petitioner, and referring to annotated Figure 10A,
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`Woehr discloses a “catheter insertion device” comprising the claimed
`
`13
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`IPR2017-01585
`Patent 8,337,463 B2
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`“catheter hub” 26, “needle” 16, and “needle protection device” 120. Id. at
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`13–15, 25–28.
`
`Addressing the claimed “valve,” Petitioner relies on Tauschinski and
`
`reasons that it would have been obvious to modify Woehr to include
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`Tauschinski’s valve. See id. at 16–19 (citations omitted). In relying on
`
`Tauschinski, Petitioner submits an annotated version of Tauschinski’s Figure
`
`2 (id. at 18), which we reproduce below:
`
`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
`
`
`
`14
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`IPR2017-01585
`Patent 8,337,463 B2
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`prevent the emergence of blood,” as disclosed by Tauschinski. Id. at 19
`
`(citing Ex. 1002 ¶¶ 68).
`
`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 20–25.
`
`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 22), which we reproduce below:
`
`
`
`According to Petitioner, and as shown in the above Figures 2 and 3,
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`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 20–21 (citing Ex. 1002 ¶ 71; 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,”
`
`15
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`IPR2017-01585
`Patent 8,337,463 B2
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`Petitioner relies on Arnett and submits annotated versions of Arnett’s
`
`Figures 11 and 12 (id. at 22–23), which we reproduce below:
`
`
`
`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 and gap 306 “therebetween to permit
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`fluid flow to flow therethrough.” Pet. 22 (citing Ex. 1005, 7:34–36; Ex.
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`1002 ¶ 73).
`
`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 further
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`obvious to modify Tauschinski’s actuator “to contain two plunger elements
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`. . . to open a valve as described in Arnett.” Id. at 24. In particular, we
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`reproduce Petitioner’s reasoning for modifying Tauschinski’s valve actuator
`
`to include Arnett’s two “plunger elements . . . having a gap therebetween,”
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`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. (Ex.
`
`16
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`IPR2017-01585
`Patent 8,337,463 B2
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`1002, Griffis Decl. ¶¶ 69, 74–75.) 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
`leakage. (Id.) 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 spring clip in the
`catheter hub, while also allowing a male luer to push on the
`actuator open the valve, 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. 24–25 (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” simply as a matter of “design
`
`choice,” because it is “one of a finite number of predictable solutions for
`
`creating space to accommodate the spring clip in the catheter hub.” Id. at
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`25.
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`5. Patent Owner’s Argument
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`Patent Owner argues that Petitioner’s reason for adding Arnett’s
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`“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
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`to include two plunger elements based on Arnett.” Id. Patent Owner argues
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`further that “the mode of operation of the valve actuating element and
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`septum of Arnett is completely different from the valve actuating element
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`17
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`IPR2017-01585
`Patent 8,337,463 B2
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`and ‘disc consisting of elastic material and having a central slit’ of
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`Tauschinski.” Id. at 51.
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`We agree with Patent Owner.
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`6. Analysis
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`We are not convinced that Petitioner has articulated a persuasive
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`reason and, more specifically, has not shown sufficient evidentiary
`
`underpinnings supporting the assertion that a person having ordinary skill in
`
`the art would have modified Tauschinski’s actuator to include Arnett’s “two
`
`plunger elements” as a matter of design choice because that is “one of a
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`finite number of predictable solutions for creating space to accommodate the
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`spring clip.” See Pet. 24–25.
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`Importantly, Petitioner’s assertion that it is simply a matter of design
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`choice to alter Tauschinski’s actuator with Arnett’s plunger and gap
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`elements lacks rational underpinnings. See In re Kahn, 441 F.3d 977, 988
`
`(Fed. Cir. 2006), cited with approval in KSR, 550 U.S. at 418 (“rejections on
`
`obvious[] grounds cannot be sustained by mere conclusory statements;
`
`instead, there must be some articulated reasoning with some rational
`
`underpinning to support the legal conclusion of obviousness.”). While it
`
`may be possible to design Tauschinski’s actuator to include the plunger and
`
`gap elements disclosed by Arnett, Petitioner has not explained adequately
`
`why one of ordinary skill in the art would have plucked this particular
`
`structure from Arnett to add to Tauschinski.
`
`As discussed above, Petitioner reasons initially that a person of skill in
`
`the art would add a gap between two plungers as a matter of design choice
`
`because “that still allows the actuator to transfer a distally directed force to
`
`open the valve slit.” Pet. 25 (citing Ex. 1002 ¶¶ 69, 74–75). This statement,
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`18
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`Patent 8,337,463 B2
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`as it is essentially reiterated by Mr. Griffis’s testimony, articulates a result, a
`
`mechanical design that would probably functionally and structurally work to
`
`transfer force, but it is not a persuasive reason or explanation as to why one
`
`of skill in the art would design an actuator with the particular elements from
`
`Arnett, as added to Tauschinski. See Ex. 1002 ¶ 74 (Mr. Griffis testifies that
`
`“[a]dding another passageway at the proximal end of the actuator is a known
`
`design choice . . . that still allows the actuator to transfer a distally directed
`
`force to open the valve slit.”). It is not enough that Arnett’s two plunger
`
`design and gap structure exists and can impart a valve opening force, there
`
`must be a particular reason a person of skill in the art would decide to use
`
`such a two plunger and gap design. See KSR, 550 U.S. at 418 (“a patent
`
`composed of several elements is not proved obvious merely by
`
`demonstrating that each of its elements was, independently, known in the
`
`prior art”).
`
`The closest that Petitioner comes to articulating a rationale to use
`
`Arnett’s proximal end structure is Mr. Griffis assertion that
`
`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.
`
`Ex. 1002 ¶ 75. However, neither Petitioner, nor Mr. Griffis, points to any
`
`evidence in the record or reasoning suggesting that the possible approaches
`
`to creating space for a spring clip and transferring force to open the valve in
`
`a catheter insertion hub are “known and finite.” See Takeda Chem. Indus. v.
`
`Alphapharm Pty., 492 F.3d 1350, 1359 (Fed. Cir. 2007) (discussing the
`
`requirements of an “obvious to try”-type obviousness rejection). Without
`
`sufficient evidence or explanation that the structural and technical
`
`19
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`Patent 8,337,463 B2
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`constraints of accommodating a spring clip within a catheter hub along with
`
`a valve and actuator structure was somehow limited, this allegation is simply
`
`a hindsight statement based on the invention described in the ’463 patent.
`
`See Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364
`
`(Fed. Cir. 2008) (Considering KSR, and the issue of a finite number of
`
`design options for an inventor, the Federal Circuit found in Ortho-McNeil
`
`that the record “does not present a finite (and small in the context of the art)
`
`number of options easily traversed to show obviousness.”). Indeed,
`
`Petitioner explains that catheter insertion assemblies designed to address
`
`needle safety have been known “[s]ince at least the 1980’s,” and that “many
`
`books, papers, and patents that identified the need for needle safety and
`
`suggested designs to achieve it.” Pet. 3 (citing Ex. 1002 ¶¶ 31–33). We
`
`appreciate that not all needle safety designs may utilize a “spring clip” as
`
`illustrated and described in the ’463 patent, but neither Petitioner nor its
`
`declarant provide any relative comparison or examples in the prior art which
`
`evidence that the universe of design options for such medical devices, and
`
`specifically the accommodation of a needle sheath or spring clip within a
`
`catheter insertion device, is technically or structurally limited. See, e.g., Ex.
`
`1002 ¶¶ 33–34 (discussing generally that OSHA had “identified ‘self-
`
`sheathing needles’ as an engineering control to reduce employee exposure to
`
`hazardous pathogens”) (citing Ex. 1015).
`
`Petitioner’s reasoning also “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, which
`
`understanding of is “necessary to the full appreciation of what [Arnett] fairly
`
`suggests.” Pet. 22–26. “It is impermissible within the framework of section
`
`20
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`Patent 8,337,463 B2
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`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 excerpts Arnett’s actuator
`
`220 and “gap” 306 to the exclusion of Arnett’s extensive disclosure
`
`regarding the purpose and operation of these components, which
`
`understanding of is “necessary to the full appreciation of what [Arnett] fairly
`
`suggests.” Pet. 22 – 26. As pointed out correctly by Patent Owner (see
`
`Prelim. Resp. 48–49) Arnett’s “at least two plunger elements . . . having a
`
`gap therebetween” 306 function to direct fluid around Arnett’s “valve”
`
`(septum 216) (see Ex. 1005, 8:26–44). To explain Arnett’s operation, we
`
`reproduce an annotated partial view of Arnett’s Figure 11, below:
`
`As shown in annotated Figure 11, and denoted by arrows and yellow
`
`highlights, when Arnett’s actuator 220 presses against septum 216, a seal
`
`
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`21
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`IPR2017-01585
`Patent 8,337,463 B2
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`between shoulder surface 284 and septum shoulder 246 breaks, thus,
`
`allowing fluid to flow through fluid passageway 306 and radially outward
`
`to fluid passageways 290. See Ex. 1005, 8:41–43 (“fluid is free to flow from
`
`the luer 140 through the fluid passageway 306 of the actuator 220 to the
`
`chamber fluid passageways 290”).
`
`Petitioner’s modification proposes to use Tauschinski’s valve 3,
`
`which directs fluid through a central slit and not radially around the outside
`
`of the valve as occurs with the fluid flow around Arnett’s septum 216. See
`
`Pet. 20–21 (citing Ex. 1002 ¶¶ 71). See id. Because fluid is directed in
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`Tauschinski’s valve through a central slit “through which a metal cannula or
`
`a vessel catheter can be pushed without obstruction,” (Ex. 1004, 2:9–13), 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 “at
`
`least two plunger elements . . . having a gap [306] therebetween,” simply as
`
`a matter of design choice to “permit fluid flow.” Pet. 22. Rather, we find
`
`that Petitioner’s reasoning selectively ignores Arnett’s specific 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—that is the redirection of fluid radially around the
`
`septum 216 in Arnett. See In re Hedges, 783 F.2d at 1041, see also In re
`
`Gal, 980 F.2d 717, 719–20 (Fed. Cir. 1992) (reversing as improper the
`
`Board’s holding that a difference in structure between an applicant’s claimed
`
`invention and the prior art was simply a matter of design choice, where the
`
`different structures of the applicant and the prior art achieve different
`
`purposes).
`
`22
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`
`Petitioner proposes the combination of Arnett with Tauschinski and
`
`Woehr to address the valve actuating element, plunger and gap limitations
`
`recited in independent claims 1, 10, and 25. See Pet. 20–25, 30–32, 36–38.
`
`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, 2, 10, 12, 25, and 28.
`
`D. Alleged Obviousness over Van Heugten and Arnett
`
`Petitioner contends that claims 1, 2, 10, 12, 25, and 28 are
`
`unpatentable over Van Heugten and Arnett. Pet. 3, 40–63.
`
`1. Van Heugten (Ex. 1006)
`
`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
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`reproduce Figure 2, below:
`
`Figure 2 depicts a cross-sectional view of Van Heugten’s catheter
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`assembly 10. Id. at 2:6–10, 19.
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