Paper 8
`Filed: September 8, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`CSL Behring GmbH and CSL Behring LLC,
`Petitioners,
`
`v.
`
`Shire ViroPharma Incorporated,
`Patent Owner.
`
`__________________
`
`Case IPR2017-01512
`Patent 9,616,111 B2
`__________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`Page 1 of 67
`
`CSL EXHIBIT 1040
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`
`TABLE OF CONTENTS
`
`I. 
`
`II. 
`
`Introduction ...................................................................................................... 1 
`
`Background ...................................................................................................... 4 
`
`III.  The Board Should Deny Both Grounds Because CSL Has Not
`Demonstrated that Schranz Is Prior Art .......................................................... 6 
`
`A. 
`
`B. 
`
`The Board Should Not Credit the Joint Declaration
`Because It Fails to Acknowledge the Consequences of
`Willful False Statements ....................................................................... 7 
`
`CSL Fails to Establish That Schranz Was “Publicly
`Accessible” More Than One Year Before the Effective
`Filing Date ............................................................................................. 9 
`
`1. 
`
`2. 
`
`CSL Relies on an Improper and Deficient Joint
`Declaration .................................................................................. 9 
`
`CSL Has Not Demonstrated That Interested
`POSAs Could Have Reasonably Located Schranz
`More Than One Year Before the Effective Filing
`Date ........................................................................................... 13 
`
`IV.  The Board Should Deny Institution Because CSL Fails to
`Establish that a POSA Would Have Been Motivated to Modify
`or Combine the Cited Art .............................................................................. 17 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`CSL Fails to Establish that a POSA Would Have
`Selected or Modified Schranz and Jiang ............................................ 20 
`
`CSL Fails to Establish that Gatlin Would Have
`Motivated a POSA to Modify Schranz or Jiang ................................. 23 
`
`CSL Fails to Offer Any Evidence as to Why a POSA
`Would Have Specifically Selected the Claimed
`Concentrations ..................................................................................... 28 
`
`CSL Fails to Offer Any Evidence as to Why a POSA
`Would Have Made the Numerous Other Modifications to
`Schranz and Jiang Required to Arrive at the Claimed
`Invention .............................................................................................. 30 
`
`i
`
`Page 2 of 67
`
`

`

`V. 
`
`IPR2017-01512
`Patent 9,616,111 B2
`The Board Should Deny Institution of Both Grounds Because
`the Cited Art Does Not Expressly or Inherently Disclose the
`Claimed Method that Achieves the Recited C1-INH Blood
`Levels ............................................................................................................. 32 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`CSL Has Not Shown that Any Cited Art Teaches
`Methods that Achieve the Claimed Blood Levels .............................. 33 
`
`CSL Fails to Articulate Any Argument that the Missing
`Blood-Level Limitation Is Inherently Supplied by the
`Cited Art .............................................................................................. 34 
`
`CSL Fails to Demonstrate that the Claimed Blood Levels
`Were the Necessary and Inevitable Result of the Cited
`Art in Ground 1, Individually or in Combination ............................... 38 
`
`CSL Fails to Demonstrate that the Claimed Blood Levels
`Necessarily and Inevitably Were the Result of the Cited
`Art in Ground 2, Individually or in Combination ............................... 42 
`
`VI.  The Board Should Decline Institution Because the Petition Is
`Based on Art and Arguments that the Patent Office Previously
`Considered ..................................................................................................... 46 
`
`A. 
`
`B. 
`
`The Board Should Deny Ground 1 Because the Patent
`Office Already Considered Schranz and CSL’s Related
`Arguments ........................................................................................... 48 
`
`The Board Should Deny Ground 2 Because the Patent
`Office Already Considered Jiang and CSL’s Related
`Arguments ........................................................................................... 53 
`
`VII.  Conclusion ..................................................................................................... 55 
`
`VIII.  Certification Under 37 C.F.R. § 42.24(d) ...................................................... 56 
`
`ii
`
`Page 3 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`
`TABLE OF AUTHORITIES
`
`Cases 
`Amneal Pharm., LLC, v. Endo Pharm. Inc.,
`IPR2014-00360, Paper 103 (July 22, 2015) .................................................. 37
`
`Arctic Cat, Inc. v. Polaris Indus. Inc.,
`IPR2017-00199, Paper 8 (Apr. 17, 2017) ......................................... 46, 48, 53
`
`Askeladden L.L.C. v. Encoditech, LLC,
`IPR2017-00452, Paper 8 (May 22, 2017) ..................................................... 34
`
`Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc.,
`796 F.2d 443 (Fed. Cir. 1986) ....................................................................... 29
`
`Boehringer Ingelheim Int’l GmbH et al. v. Biogen Inc.,
`IPR2015-00418, Paper 14 (July 13, 2015) .................................................... 36
`
`Bumble Bee Foods, LLC v. Kowalski,
`IPR2014-00224, Paper 18 (June 5, 2014) ...................................................7, 8
`
`Coalition For Affordable Drugs II LLC, v. Cosmo Techs. Ltd.,
`IPR2015-00988, Paper 57 (Oct. 5, 2016) ...................................................... 27
`
`Daifuku Co., Ltd. v. Murata Machinery, Ltd.,
`IPR2015-00088, Paper 63 (May 3, 2016) .............................................. 24, 27
`
`Dep’t of Justice v. Iris Corp. Berhad,
`IPR2016-00497, Paper 7 (July 25, 2016) ........................................... 9, 10, 13
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ..................................................................... 24
`
`In re Fritch,
`972 F.2d 1260 (Fed. Cir. 1992) ..................................................................... 29
`
`In re Klopfenstein,
`380 F.3d 1345 (Fed. Cir. 2004) .............................................................. 12, 13
`
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .................................................. 17, 20, 30, 31
`
`iii
`
`Page 4 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012) .................................................. 33, 35, 36, 37
`
`In re Nuvasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) ..................................................................... 17
`
`In re Oelrich,
`666 F.2d 578 (C.C.P.A. 1981) ....................................................................... 35
`
`Insite Vision Inc. v. Sandoz, Inc.,
`783 F.3d 853 (Fed. Cir. 2015) ....................................................................... 29
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ..................................................................... 22
`
`Kingsford Prods. Co., LLC, v. Creative Spark, LLC,
`IPR2016-01831, Paper 7 (Mar. 17, 2017) ....................................................... 6
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)....................................................................................... 23
`
`Mylan Laboratories Ltd. v. Aventis Pharma S.A.,
`IPR2016-00712, Paper 9 (Sept. 22, 2016) ..................................................... 37
`
`Oil States Energy Services, LLC v. Greene’s Energy Group, LLC,
`137 S. Ct. 2239 (2017) ................................................................................... 56
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) ..................................................................... 27
`
`Par Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ............................................................. passim
`
`Prism Pharma Co., Ltd. v. Choongwae Pharma Corp.,
`IPR2014-00315, Paper, 14 (July 8, 2014) ..................................................... 46
`
`Purdue Pharma L.P. v. Depomed, Inc.,
`643 F. App’x 960 (Fed. Cir. 2016) ................................................................ 23
`
`Sandoz Inc. v. EKR Therapeutics LLC,
`IPR2015-00005, Paper 20 (Apr. 24, 2015) ....................................... 28, 33, 38
`
`iv
`
`Page 5 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`
`SRI Int’l, Inc. v. Internet Sec. Sys., Inc.,
`511 F.3d 1186 (Fed. Cir. 2008) ............................................................. passim
`
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) ............................................................. passim
`
`W.L. Gore & Assocs., Inc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) ..................................................................... 29
`
`Westinghouse Air Brake Tech. Corp. v. Siemens Indus., Inc.,
`IPR2017-00582, Paper 12 (July 19, 2017) ....................................... 17, 19, 21
`
`Yotrio Corp. v. Lakesouth Holdings, LLC,
`IPR2017-00298, Paper 12 (May 15, 2017) ................................................... 46
`
`Statutes 
`28 U.S.C. § 1746 ....................................................................................................7, 8
`
`35 U.S.C. § 102(a) ................................................................................................... 31
`
`35 U.S.C. § 102(b) ...................................................................................... 1, 6, 7, 31
`
`35 U.S.C. § 311(b) ..................................................................................................... 1
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 314(a) ..................................................................................................... 1
`
`35 U.S.C. § 325(d) .................................................................................. 3, 46, 48, 53
`
`Rules 
`Fed. R. Evid. 602 ................................................................................................ 9, 12
`
`Regulations 
`37 C.F.R. § 1.68 .....................................................................................................7, 8
`
`37 C.F.R. § 42.104(b)(3) ............................................................................................ 5
`
`37 C.F.R. § 42.104(b)(4) ..................................................................................... 5, 31
`
`37 C.F.R. § 42.107(a) ................................................................................................. 1
`
`37 C.F.R. § 42.2 .....................................................................................................7, 8
`
`v
`
`Page 6 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`Patent 9,616,111 B2
`37 C.F.R. § 42.24(d) ................................................................................................ 56
`37 C.F.R. § 42.24(d) ................................................................................................ 56
`
`IPR2017-01512
`
`37 C.F.R. § 42.53(a) ................................................................................................... 7
`37 CPR. §42.53(a) ................................................................................................... 7
`
`
`
`Page 7 of 67
`
`vi
`
`Vi
`
`Page 7 of 67
`
`

`

`PATENT OWNER’S EXHIBIT LIST
`
`IPR2017-01512
`
`Patent 9,616,111 B2
`
`Exhibit No.
`
`Description
`
`200 1
`
`Certified File History of US. Patent No. 9,616,1 1 1.
`
`2002
`
`2003
`
`2004
`
`2005
`
`EP0 Patent Application NO- EP 14 762 343.3, Decision to Grant
`(June 1, 2017).
`
`UK Patent Application Publication No. GB 2530921 (Apr. 6, 2016).
`
`Intemational Patent Application Publication NO. WO 2014/145519
`(Sept. 18, 2014).
`
`International Patent Application Publication No. WO 2016/131958
`(Aug. 25, 2016).
`
`2006
`
`Anas M- Fathallah et al., Anatomical, Physiological and
`Experimental Factors Aflecting the Bioavailabilily ofSC
`Administered Large Biotherapeutics, 104(2) J. PHARM. SCI. 301
`(201 5).
`
`Danielle N- McLennan et al., Subcutaneous Drug Delivery and the
`Role ofthe Lymphatics, 2(1) DRUG DISCOVERY TODAY: TECHN. 89
`(2005).
`
`Thousands Assemble in Orlandofor the 2012 Annual Meeting,
`AAAAI.ORG, http://enews.aaaai.org/april-2012/news-briefs/
`thousands-assemble-in—orlandO-for-the-Z0 1 2-annual-meeting
`(last visited June 16, 2017).
`
`
`
`2009
`
`AM. ACAD. OF ALLERGY, ASTHMA & IMMUNOLOGY, FINAL PROGRAM
`
`2012 ANNUAL MEETING (2012).
`
`2010
`
`201 1
`
`2012
`
`2013
`
`February 2012 Issue of the Journal ofAllergy & Clinical
`Immunology, JACIONLINEORG (last visited Sept. 2, 2017).
`
`Supplement to the February 2012 Issue ofthe Journal ofAllergy &
`Clinical Immunology, JACIONLINEORG (last Visited June 15, 2017).
`
`129(2) J. ALLERGY & CLIN. IMMUNOL. (SUPPLEMENT) (Feb. 2012).
`
`CINRYZE, Trademark Information, Registration NO. 3,867,834
`(Oct- 26, 2010).
`
`Page 8 of 67
`
`vii
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`Pursuant to 35 U.S.C. § 313 and 37 C.F.R. § 42.107(a), Patent Owner Shire
`
`ViroPharma Incorporated (“Shire”) submits this Preliminary Response to the
`
`Petition for Inter Partes Review of Patent No. 9,616,111 (“the ’111 patent”) filed
`
`by Petitioners CSL Behring GmbH and CSL Behring LLC (collectively “CSL”).
`
`I.
`
`Introduction
`
`To justify institution of its Petition, CSL must meet the threshold
`
`requirement of establishing that there is a “reasonable likelihood” that it would
`
`prevail with respect to at least one of the challenged claims. 35 U.S.C. § 314(a);
`
`see also 35 U.S.C. § 311(b). CSL has not made this showing due to at least four
`
`critical failures of proof—each of which independently warrants denial of CSL’s
`
`Petition. Because of these deficiencies, CSL has not shown a reasonable
`
`likelihood that any of the challenged claims of the ’111 patent are invalid. CSL’s
`
`Petition should be denied.
`
`First, CSL has not shown that Schranz, which it relies on in both Grounds,
`
`is prior art. In order to show that Schranz is a printed publication under 35 U.S.C.
`
`§ 102(b), CSL relies on a flawed joint declaration. The joint declaration is
`
`improper because it does not attest that the declarants were warned about the
`
`consequences of making willful false statements. And because the declaration was
`
`made jointly, it is an improper combined document, which obscures the nature and
`
`origin of its assertions. Due to these and numerous other deficiencies, the joint
`
`– 1 –
`
`Page 9 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`declaration does not establish that Schranz was disseminated or reasonably could
`
`have been located by a person of ordinary skill in the art (“POSA”).
`
`Second, CSL has not demonstrated that a POSA would have selected
`
`Schranz (Ground 1) or Jiang (Ground 2), or would have combined either reference
`
`with Gatlin to reach the claimed concentrations. CSL provides no argument that a
`
`POSA found Schranz or Jiang lacking, or that either expressed any specific
`
`problem. Indeed, CSL even argues that “any alleged need for a high-concentration
`
`C1-INH formulation for sc treatment of HAE had been satisfied by” the time of
`
`invention. (Pet. 56). Thus, according to CSL’s own argument, there would not
`
`have been any motivation to modify the art.
`
`Further, CSL’s failure to articulate specific reasoning to support its
`
`obviousness argument is evident from the numerous questions that the Petition
`
`does not address, as explained below. In particular, CSL fails to account for
`
`disclosures in its cited art that teach away or diverge from CSL’s recommended
`
`solution. CSL’s motivation arguments are legally deficient and are improper
`
`hindsight. Moreover, even if a POSA were motivated to modify the art to increase
`
`concentration, CSL provides no reasoned basis to select the specific concentration
`
`enumerated by the claims.
`
`Third, CSL has not shown that the cited references in both Grounds, either
`
`individually or collectively, expressly disclose the recited C1-INH blood levels
`
`– 2 –
`
`Page 10 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`after administering C1-INH at the claimed concentrations. Therefore, CSL must
`
`show that the claimed blood levels would have been the inherent result of the
`
`combination of the Schranz or Jiang references with Gatlin. CSL does not offer
`
`evidence to meet the Federal Circuit’s stringent standard for inherency—that the
`
`claimed result must have necessarily and inevitably resulted from the combination
`
`of art. At most, CSL merely argues that a POSA would have “reasonably
`
`predicted” or “routinely achieved” the claimed blood levels. (Pet. 27, 28, 41).
`
`Adopting CSL’s flawed argument would be legal error.
`
`Fourth, the Board should deny institution of both Grounds under 35 U.S.C.
`
`§ 325(d) because CSL advances substantially the same art and arguments that were
`
`considered—and rejected—by the Patent Office during prosecution. CSL’s
`
`argument in Ground 1 based on Schranz is cumulative. In fact, CSL has already
`
`argued in third-party observations to a related European patent that Schranz
`
`renders the claims obvious in light of art, including Gatlin, disclosing the allegedly
`
`typical volumes of subcutaneous administration. Shire submitted these third-party
`
`observations to the Patent Office, which stated that the observations did not alter
`
`its conclusion of novelty and non-obviousness. (Ex. 1001 at 3496). Furthermore,
`
`CSL’s argument in Ground 2 based on Jiang is also cumulative. The Patent Office
`
`did not just consider Jiang, it used it as a primary reference in multiple prior-art
`
`rejections. And the Patent Office combined Jiang with art that allegedly described
`
`– 3 –
`
`Page 11 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`typical volumes of subcutaneous administration—art that even CSL acknowledges
`
`is “similar” to Gatlin. (Pet. 39 n.10). Thus, CSL’s Ground 2 is also cumulative
`
`over the prosecution of the ’111 patent. Consequently, the Board should not
`
`institute either Ground.
`
`II. Background
`Shire is a global biotechnology company committed to serving people with
`
`rare diseases and highly specialized conditions, such as hereditary angioedema
`
`(“HAE”). HAE is a rare genetic disorder in which patients do not produce
`
`sufficient amounts of active C1 esterase inhibitor (“C1-INH”). This deficiency
`
`results in recurring, unpredictable, and life-threatening attacks of subcutaneous/
`
`submucosal swelling in the face, limbs, abdomen, tongue, genitals, and/or larynx.
`
`(Ex. 1000 at 7). Restoring levels of C1-INH to normal levels is an effective
`
`measure for the treatment of HAE. (Ex. 1000 at 7).
`
`Shire owns the ’111 patent, which is titled “C1-INH Compositions and
`
`Methods for the Prevention and Treatment of Disorders Associated with C1
`
`Esterase Inhibitor Deficiency.” The earliest document to which the ’111 patent
`
`claims priority is U.S. Provisional Patent Application No. 61/791,399, which was
`
`filed on March 15, 2013. The ’111 patent has one independent claim, which
`
`recites:
`
`
`
`– 4 –
`
`Page 12 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`A method for treating hereditary angioedema (HAE),
`
`said method comprising subcutaneously administering to
`a subject in need thereof a composition comprising
`
`a C1 esterase inhibitor,
`
`a buffer selected from citrate or phosphate, and
`
`having a pH ranging from 6.5–8.0,
`
`wherein the C1 esterase inhibitor is administered at a
`concentration of at least about 400 U/mL and a dose of at
`least about 1000 U, and
`
`composition
`the
`administration of
`the
`wherein
`comprising the C1 esterase inhibitor increases the level
`of C1 esterase inhibitor in the blood of the subject to at
`least about 0.4 U/mL, and
`
`wherein the C1 esterase inhibitor comprises an amino
`acid sequence at least 95% identical to residues 23 to 500
`of SEQ ID NO:1.
`
`(Ex. 1000 at claim 1). Claims 2–18 directly or indirectly depend from claim 1 and
`
`recite additional limitations. For example, claim 2 depends from claim 1 and
`
`recites C1-INH in a “concentration of at least about 500 U/mL.”
`
`In its Petition, CSL asserts that claims 1–18 are obvious on two grounds. As
`
`part of the Petition, CSL was required to explain how each “challenged claim is to
`
`be construed,” so it could then explain “[h]ow the construed claim is
`
`unpatentable.” 37 C.F.R. § 42.104(b)(3)–(b)(4). But CSL offers no claim
`
`constructions.
`
`– 5 –
`
`Page 13 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`CSL asserts that Schranz and Jiang are the “primary” references for
`
`Grounds 1 and 2, respectively. (Pet. 2). In Ground 1, CSL further alleges that the
`
`claims “would have been obvious over Schranz in view of Gatlin.” (E.g., Pet. 30).
`
`In Ground 2, CSL further alleges that the claims “would have been obvious over
`
`Jiang in view of Gatlin.” (E.g., Pet. 44).
`
`CSL argues that a POSA would have been motivated to modify the primary
`
`references Schranz or Jiang based on Gatlin. (Pet. 20–24, 38–40). CSL asserts
`
`that Gatlin recommended targeting “low” volumes of fluid for subcutaneous
`
`administration. (Pet. 21). Based on this interpretation of Gatlin, CSL concludes
`
`that a POSA would have been motivated to reduce the total volume and number of
`
`injections for subcutaneous administration to reduce pain. (Pet. 21). And then
`
`based on that conclusion, CSL argues that a POSA would have been motivated to
`
`increase the C1-INH concentration of its asserted art. (Pet. 22). From there, CSL
`
`argues that a POSA would have selected the concentrations recited by the claims
`
`(i.e., “at least about 400 U/mL” for claim 1 or “at least about 500 U/mL” for
`
`claim 2).
`
`III. The Board Should Deny Both Grounds Because
`CSL Has Not Demonstrated that Schranz Is Prior Art
`CSL has not met its burden to establish that Schranz is a “printed
`
`publication” under 35 U.S.C. § 102(b). See Kingsford Prods. Co., LLC, v.
`
`Creative Spark, LLC, IPR2016-01831, Paper 7, at 25–26 (Mar. 17, 2017). Schranz
`
`– 6 –
`
`Page 14 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`is Ground 1’s primary reference, (Pet. 2, 15), and is also relied on by CSL in its
`
`Ground 2 argument. (Pet. 43, 46; see also Pet. 42). But CSL has not established
`
`that Schranz was publicly accessible more than a year before the critical date and,
`
`therefore, has not established Schranz as a § 102(b) “printed publication.” Because
`
`CSL has not established that Schranz is prior art, it cannot prove that any
`
`challenged claim is obvious.
`
`A. The Board Should Not Credit the Joint Declaration
`Because It Fails to Acknowledge the Consequences
`of Willful False Statements
`
`The Board should give the Joint Declaration—CSL’s only evidence that
`
`Schranz is prior art—no weight because it does not qualify as an affidavit under
`
`the Board’s rules. (Ex. 1013); Bumble Bee Foods, LLC v. Kowalski, IPR2014-
`
`00224, Paper 18, at 14–15 (June 5, 2014). In an IPR, uncompelled testimonial
`
`evidence is submitted as an affidavit. 37 C.F.R. § 42.53(a). An “affidavit” means
`
`a declaration under 37 C.F.R. § 1.68 or 28 U.S.C. § 1746. 37 C.F.R. § 42.2
`
`(defining “affidavit”). A declaration under § 1.68 is proper “if, and only if,” the
`
`declarant “is . . . warned that willful false statements” are criminally punishable
`
`and may jeopardize the validity of an IPR petition. 37 C.F.R. § 1.68.
`
`Additionally, § 1.68 requires that the willful-false-statements warning to be “on the
`
`same document” as the declaration. Id. A declaration under § 1746 is proper only
`
`– 7 –
`
`Page 15 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`if it is “subscribed” by the declarant “as true under penalty of perjury,” and dated
`
`and signed in the form specified by § 1746. See 28 U.S.C. § 1746.
`
`In Bumble Bee, the Board “g[a]ve no weight to the Friend declaration”
`
`because, “in the Declaration, the declarant was not warned that willful false
`
`statements are punishable by fine or imprisonment, or sworn under penalty of
`
`perjury.” IPR2014-00224, Paper 18, at 14–15 (citing § 42.2, § 1.68, and § 1746).
`
`“Consequently,” the Board denied the ground that relied on the Friend declaration.
`
`IPR2014-00224, Paper 18, at 15.
`
`The Board should give the Joint Declaration no weight because: (i) the Joint
`
`Declaration contains no warning, as required by § 1.68, that willful false
`
`statements may subject the joint declarants to criminal punishment and may
`
`jeopardize the validity of the Petition; and (ii) the joint declarants did not execute
`
`the Joint Declaration under penalty of perjury in the manner required by § 1746.1
`
`Bumble Bee, IPR2014-00224, Paper 18, at 14–15. Without the Joint Declaration,
`
`CSL cannot prove that Schranz is prior art. The Board, therefore, should deny both
`
`Grounds.
`
`
`1 Notably, CSL was apparently able to satisfy § 1.68 in its three other declarations.
`
`(See Ex. 1012 ¶ 82; Ex. 1014 ¶ 13; Ex. 1015 ¶ 67).
`
`– 8 –
`
`Page 16 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`B. CSL Fails to Establish That Schranz Was “Publicly Accessible”
`More Than One Year Before the Effective Filing Date
`CSL has failed to meet its burden to show that Schranz was publicly
`
`accessible. The “touchstone in determining whether a reference constitutes a
`
`‘printed publication’” is whether that reference was publicly accessible. SRI Int’l,
`
`Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194–95 (Fed. Cir. 2008) (emphasis
`
`removed). A reference is “publicly accessible” if it “has been disseminated or
`
`otherwise made available to the extent that persons interested and ordinarily skilled
`
`in the subject matter or art exercising reasonable diligence, can locate it.” Id. The
`
`Board should deny both Grounds because CSL has not shown that Schranz was
`
`disseminated or reasonably could have been located more than one year before the
`
`effective filing date.
`
`CSL Relies on an Improper and Deficient Joint Declaration
`
`1.
`CSL’s only evidence that Schranz was disseminated or otherwise made
`
`available is the Joint Declaration. (Pet. 17). But because it has two declarants, the
`
`Joint Declaration “obscures the precise nature and origin of a number of factual
`
`assertions” to such an extent that it fails to demonstrate that Schranz was
`
`disseminated at all. See Dep’t of Justice v. Iris Corp. Berhad, IPR2016-00497,
`
`Paper 7, at 9–10 (July 25, 2016) (holding a joint declaration to be an improper
`
`“combined document”); see also Fed. R. Evid. 602 (“Need for Personal
`
`Knowledge”). The Joint Declaration here also “invites innumerable practical
`
`– 9 –
`
`Page 17 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`difficulties . . . in assessing the reliability of the statements made.” See Dep’t of
`
`Justice, Paper 7, at 10. Therefore, CSL has not established the necessary elements
`
`for a printed publication under § 102(b).
`
`For example, the Joint Declaration only states that the declarants attended
`
`the conference, but it does not state that either declarant actually saw the Schranz
`
`poster on display on March 6th. The Joint Declaration merely states: (i) “We both
`
`attended the 2012 [AAAAI conference] that was held from March 2 to March 6 in
`
`Orlando, Florida,” and (ii) “The Schranz poster was displayed as a late breaker
`
`abstract on Tuesday, March 6th, at 9:45AM ET.” (Ex. 1013 ¶ 2 (emphasis added),
`
`¶ 4 (emphasis added)). As another example, the statement that the Schranz
`
`handout was “picked-up by us” is ambiguous. (Ex. 1013 ¶ 5 (emphasis added)). If
`
`only Mr. Waldhauser picked up a handout, it would undermine CSL’s allegation
`
`that Schranz was publicly accessible because Mr. Waldhauser is a “marketing/
`
`communication specialist” and not a POSA under CSL’s definition. (Ex. 1013 ¶ 1;
`
`Pet. 14–15). Only “persons interested and ordinarily skilled in the subject matter
`
`or art” are relevant to the public-accessibility standard.2 SRI, 511 F.3d at 1194–95.
`
`
`2 Relatedly, CSL concludes that Dr. Schranz is not a POSA even though she “holds
`
`a doctorate of medicine degree and has spent over 20 years conducting clinical
`
`research and trials involving treatments for various diseases including [HAE].”
`
`
`
`– 10 –
`
`Page 18 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`The Joint Declaration also contains numerous other significant omissions.
`
`In particular, the Joint Declaration does not establish:
`
`a) that the Schranz handout was distributed to any person that qualifies as a
`POSA, even under CSL’s definitions;
`
`b) how many copies of the Schranz handout were available or actually
`distributed;3
`
`c) the length of time the Schranz handout was available to be “picked-up,”
`(see Ex. 1013 ¶ 5);
`
`d) the length of time the Schranz poster was on “display,”
`(see Ex. 1013 ¶ 4);
`
`e) how many persons actually viewed the Schranz poster;4 and
`
`f) whether any persons who allegedly viewed the poster qualify as POSAs,
`(see Ex. 1013 ¶¶ 4–5).
`
`
`(Pet. 12 n.5). If Dr. Schranz is not a POSA, CSL has not established that any
`
`other conference attendee would qualify as a POSA either.
`
`3 In fact, the joint declarants concede that they “do not know how many copies of
`
`the Schranz poster were taken by viewers during the [AAAAI conference].”
`
`(Ex. 1013 ¶ 5 n.1).
`
`4 The joint declarants instead merely assert the number of people the conference
`
`organizers claim attended some part of the five-day conference. (See Ex. 1013 ¶2
`
`(paraphrasing Shire’s Ex. 2008)).
`
`– 11 –
`
`Page 19 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`Moreover, the Joint Declaration obfuscates whether it reflects firsthand
`
`knowledge of either declarant. See Fed. R. Evid. 602. Rather than rely on
`
`personal knowledge, the Joint Declaration instead appears to rely on what the
`
`conference purportedly “mandated” or the conference organizers’ estimated
`
`number of conference attendees. (Ex. 1013 ¶¶ 2, 4). Indeed, the Joint Declaration
`
`provides only the haziest “recollection” of the Schranz poster’s display. The Joint
`
`Declaration—without any stated basis—concludes that the unknown number of
`
`“physicians” who purportedly viewed the poster were “relevant” or “actively
`
`treating patients with [HAE],” (see Ex. 1013 ¶ 4). Further, the Joint Declaration
`
`states that “one of the authors” had discussions with those “relevant physicians”
`
`and “other industry representatives,” (Ex. 1013 ¶ 4), but it does not identify any of
`
`those physicians or representatives, or try to qualify them as POSAs. See SRI, 511
`
`F.3d at 1194–95 (identifying “persons interested and ordinarily skilled in the
`
`subject matter or art” as relevant to the “public accessibility” standard).
`
`CSL relies heavily on Klopfenstein. (Pet. 16–18 (citing In re Klopfenstein,
`
`380 F.3d 1345 (Fed. Cir. 2004)). The challenger in Klopfenstein set forth facts
`
`establishing the public accessibility of a poster presentation, and those facts were
`
`not disputed. See Klopfenstein, 380 F.3d at 1347–48 (“As there are no factual
`
`disputes between the parties in this appeal . . . .”). In contrast, here, CSL fails to
`
`set forth facts establishing public accessibility of Schranz due to its improper and
`
`– 12 –
`
`Page 20 of 67
`
`

`

`IPR2017-01512
`Patent 9,616,111 B2
`deficient Joint Declaration. CSL’s focus on Klopfenstein ignores the threshold
`
`question of whether the Joint Declaration adequately supports CSL’s argument.
`
`Thus, CSL’s reliance on Klopfenstein is misplaced.
`
`Even if the Board allows the declarants to file substitute individual
`
`declarations, any substitute declaration “may not . . . alter the content of the
`
`declarants’ existing statements or introduce new statements.” See Dep’t of Justice,
`
`IPR2016-00497, Paper 7, at 11. Thus, the Joint Declaration is irremediably
`
`insufficient. As CSL’s argument for public accessibility is entirely premised on
`
`the Joint Declaration, CSL has failed to establish that Schranz is prior art.
`
`2.
`
`CSL Has Not Demonstrated That Interested POSAs Could
`Have Reasonably Located Schranz More Than One Year
`Before the Effect