`U.S. Patent No. 7,049,328
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioners,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER APOTEX TECHNOLOGIES, INC.’S
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(c)
`
`
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
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`
`
`TABLE OF CONTENTS
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`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED ........... 1
`
`LEGAL STANDARDS ................................................................................... 1
`
`
`I.
`
`II.
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`III. BASIS FOR RELIEF REQUEST ................................................................... 2
`
`
`A.
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`
`The Decision Failed to Properly Apply the Law Governing Inherent
`Anticipation ........................................................................................... 2
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`
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`
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`1.
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`2.
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`3.
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`The Board Misapplied the Law Governing Inherency in the
`Analysis of Hoffbrand 1998 ........................................................ 3
`
`The Board Misapplied the Law Governing Inherency in the
`Analysis of Olivieri Abstract 1995 ............................................. 5
`
`The Board Misapplied the Law Governing Inherency in the
`Analysis of Olivieri 1995 .......................................................... 10
`
`B.
`
`
`The Board Misapplied the Law Governing Inherency in its
`Obviousness Analysis ......................................................................... 12
`
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`IV. CONCLUSION .............................................................................................. 13
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`
`
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`i
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`U.S. Patent No. 7,049,328
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`TABLE OF AUTHORITIES
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`PAGE(S)
`
`
`CASES
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`Agilent Tech., Inc. v. Affymetrix, Inc.,
`
`567 F.3d 1366 (Fed. Cir. 2009) .................................................... 2, 4, 5, 6, 11
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`Coalition For Affordable Drugs VI, LLC v. Celgene Corp.,
`
`Case IPR2015-01096, -01102, -01103 (Sept. 8, 2017) (Paper 78) ................. 9
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`Eli Lilly & Co. v. Bd. Of Regents of the Univ. of Wash.,
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`334 F.3d 1264 (Fed. Cir. 2003) ....................................................................... 2
`
`In re Montgomery,
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`677 F.3d 1375 (Fed. Cir. 2012) ................................................ 4, 5, 6, 7, 8, 11
`
`In re Oelrich,
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`666 F.2d 578 (CCPA 1981) .............................................................. 3, 4, 6, 11
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`In re Robertson,
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`169 F.3d 743 (Fed. Cir. 1999) .......................................................... 4, 6, 7, 11
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`MEHL/Biophile Int’l Corp. v. Milgraum,
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`192 F.3d 1362 (Fed. Cir. 1999) ....................................................................... 4
`
`PNY Tech., Inc. v Phison Elecs. Corp.,
`
`Case IPR2013-00472 (PTAB April 23, 2014) (Paper 16) ............................... 1
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`Stevens v. Tamai,
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`366 F.3d 1325 (Fed. Cir. 2004) ....................................................................... 2
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`STATUTES
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`37 C.F.R. § 42.65(a) ................................................................................................... 8
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`37 C.F.R. § 42.71(c) ...............................................................................................1, 2
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`37 C.F.R. § 42.71(d) .................................................................................................. 2
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`
`
`
`
`ii
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`
`
`
`REGULATIONS
`
`77 Fed. Reg. at 48,763 ............................................................................................... 8
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`iii
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`Pursuant to 37 C.F.R. § 42.71(c), Patent Owner, Apotex Technologies, Inc.
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`
`
`(“Patent Owner”), hereby submits the following Request for Rehearing in response
`
`to the Decision, Institution of Inter Partes Review of U.S. Patent No. 7,049,328
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`(“the Decision”) (Paper 7).
`
`I.
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
`
`The Decision ordered review on six grounds of unpatentability: (i) claims 1,
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`2, 4-11, 13-17, and 19 as anticipated by Hoffbrand 1998; (ii) claims 1, 2, 4-11, 13-
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`17, and 19 as anticipated by Olivieri Abstract 1995; (iii) claims 1, 2, 4-11, 13-17,
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`and 19 as anticipated by Olivieri 1995; (iv) claims 1, 2, 4-17, and 19 as obvious
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`over Hoffbrand 1998; (v) claims 1, 2, 4-17, and 19 as obvious over Olivieri
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`Abstract 1995; and, (vi) claims 1, 2, 4-17, and 19 as obvious over Olivieri 1995.
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`Patent Owner requests that the Patent Trial and Appeal Board (“the Board”)
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`reconsider its decision to institute on all grounds in light of the governing law on
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`inherency. See, e.g., PNY Tech., Inc. v. Phison Elecs. Corp., IPR2013-00472,
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`(PTAB April 23, 2014) (Paper 16) (granting-in-part a request for rehearing because
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`the Board “misapplied the standard for inherency”). Patent Owner further requests
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`that no trial be instituted on U.S. Patent No. 7,049,328 (“the ’328 patent”).
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`II. LEGAL STANDARDS
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`A request for rehearing “must specifically identify all matters the party
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`1
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`
`
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`believes the Board misapprehended or overlooked, and the place where each
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`matter was previously addressed in a motion, an opposition, or reply.” 37 C.F.R.
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`§ 42.71(d). “When rehearing a decision on petition, the panel will review the
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`decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). An abuse of discretion
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`is found where the decision “(1) is clearly unreasonable, arbitrary, or fanciful; (2)
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`is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact
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`findings; or (4) involves a record that contains no evidence on which the Board
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`could rationally base its decision.” Stevens v. Tamai, 366 F.3d 1325, 1330 (Fed.
`
`Cir. 2004) (quoting Eli Lilly & Co. v. Bd. Of Regents of the Univ. of Wash., 334
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`F.3d 1264, 1266-67 (Fed. Cir. 2003)).
`
`III. BASIS FOR RELIEF REQUEST
`
`A. The Decision Failed to Properly Apply the Law Governing
`Inherent Anticipation
`Patent Owner requests reconsideration of the decision to institute on claims
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`1, 2, 4-11, 13-17, and 19 as anticipated by Hoffbrand 1998, Olivieri Abstract 1995,
`
`and Olivieri 1995, because the Board failed to adhere to the legal standards for
`
`inherency. Specifically, Patent Owner respectfully submits that the evidence of
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`record fails to show that any of Hoffbrand 1998, Olivieri Abstract 1995, and
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`Olivieri 1995 “unavoidably teaches” the treatment of patients who have an iron
`
`overload condition of the heart or iron-induced cardiac disease. See Agilent Tech.,
`
`
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`2
`
`
`
`
`Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (citing In re Oelrich,
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`666 F.2d 578, 581 (CCPA 1981)).
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`1.
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`The Board Misapplied the Law Governing Inherency in the
`Analysis of Hoffbrand 1998
`Independent claims 1, 2, and 4-10 of the ’328 patent require treatment of
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`patients with a therapeutically effective amount of deferiprone who have “‘an iron
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`overload condition of the heart’ or ‘iron-induced cardiac disease’ . . . .” (Decision
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`at 19.) The decision to institute on anticipation by Hoffbrand 1998 rests on a
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`finding “of the inevitability of treatment success by . . . administration of an
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`amount of deferiprone, 75 mg/kg . . . to at least ten patients with iron content
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`‘within the range that has been associated with cardiac disease’.” (Id. at 20.)
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`Hoffbrand 1998 does not explicitly disclose administering a therapeutically
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`effective amount of deferiprone to patients having “an iron overload condition of
`
`the heart” or “iron-induced cardiac disease.” (See Patent Owner’s Preliminary
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`Response at 39-40.) Accordingly, the finding that Hoffbrand 1998 discloses this
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`limitation relies on inherency stemming from the assumption that “‘10 patients
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`[who] had a liver iron content above 15.0 mg/kg dry weight’ . . . necessarily had
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`iron levels sufficient for iron overload conditions of the heart.” (Decision at 19.)
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`The assumption on which the Board relies, however, is insufficient to meet the
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`legal requirements for inherency.
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`3
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`
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`It is well settled that inherency “may not be established by probabilities or
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`possibilities.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (quoting In re
`
`Oelrich, 666 F.2d at 581); MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362,
`
`1365 (Fed. Cir. 1999). “The mere fact that a certain thing may result from a given
`
`set of circumstances is not sufficient.” (Id.) In fact, “inherency does not follow
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`even from a very high likelihood that a prior art method will result in the claimed
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`invention.” In re Montgomery, 677 F.3d 1375, 1384 (Fed. Cir. 2012). Rather,
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`“[t]he keystone of the inherency doctrine is inevitability.” Id. at 1384 (“Our
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`precedent has been steadfast in this strict requirement of inevitability.”) Inherency
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`requires that the “reference unavoidably teaches the property in question.” Agilent
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`Tech., 567 F.3d at 1383 (citing In re Oelrich, 666 F.2d at 581).
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`As stated in Patent Owner’s Preliminary Response, “there is a discordance
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`between liver iron content and heart iron content” and “liver iron content cannot be
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`used to establish that a patient has iron induced cardiac disease.” (Preliminary
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`Response at 39 (emphasis in original) (citing Ex. 2003 at ¶ 51).) Even Hoffbrand
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`1998 never discloses that any patient has an iron overload condition of the heart or
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`iron-induced cardiac disease on the basis of liver iron content. Instead, Hoffbrand
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`1998 states—as quoted by the Board—that the 10 patients had liver iron content
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`“‘that has been associated with cardiac disease.’” (Decision at 19, 20 (emphasis
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`added).)
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`4
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`
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`Despite being fully cognizant that Hoffbrand 1998 merely discloses an
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`“association” between liver iron content and cardiac disease, the Board nonetheless
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`instituted trial based on inherent anticipation by Hoffbrand 1998 thereby
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`committing legal error. Indeed, although the Federal Circuit has made clear that
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`inherency cannot be established based on “probabilities or possibilities,” the Board
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`based its conclusion on an “association” between liver iron content and cardiac
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`disease. An “association,” however, does not meet the strict requirement of
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`inevitability. Montgomery, 677 F.3d at 1384 (“The keystone of the inherency
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`doctrine is inevitability.”) Inherency requires that the “reference unavoidably
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`teaches the property in question,” see Agilent Tech., 567 F.3d at 1383, and
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`Hoffbrand 1998 fails to unavoidably or inevitably teach that patients having an
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`iron overload condition of the heart or iron-induced cardiac disease were treated
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`using deferiprone.
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`Accordingly, Patent Owner requests that the decision to institute on claims
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`1, 2, 4-11, 13-17, 19 as anticipated by Hoffbrand 1998 be withdrawn and the
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`ground denied.
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`2.
`
`The Board Misapplied the Law Governing Inherency in the
`Analysis of Olivieri Abstract 1995
`The decision to institute on anticipation by Olivieri Abstract 1995 rests on
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`an erroneous finding “that the reduced T2 relaxation time [“TRT”] data in Olivieri
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`5
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`
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`Abstract 1995 is evidence that patients were experiencing an iron overload
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`condition of the heart . . . .” (Decision at 24.) However, Olivieri Abstract 1995
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`never equates abnormal TRT values with “an iron overload condition of the heart”
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`or “iron-induced cardiac disease.” Accordingly, the finding that Olivieri Abstract
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`1995 discloses this limitation relies on inherency stemming from the assumption
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`that “that the reduced T2 relaxation time data in Olivieri Abstract 1995 is evidence
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`that patients were experiencing an iron overload condition of the heart . . . .” (Id.)
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`This assumption, however, is insufficient to meet the legal requirements for
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`inherency. As explained above, inherency “may not be established by probabilities
`
`or possibilities.” In re Robertson, 169 F.3d at 745. Rather, “[t]he keystone of the
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`inherency doctrine is inevitability.” Montgomery, 677 F.3d at 1384; see also
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`Agilent Tech., 567 F.3d at 1383 (citing In re Oelrich, 666 F.2d at 581).
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`As stated in Patent Owner’s Preliminary Response “the presence of cardiac
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`iron does not definitively [i.e., inevitably] signal an iron overload condition of the
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`heart.” (Preliminary Response at 43 (citing Ex. 2003 at ¶ 56 (“to the extent that
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`iron, albeit an unquantifiable amount, was detected in patients in Olivieri Abstract
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`1995, this does not indicate that said patients necessarily had an iron overload
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`condition of the heart”).) Indeed, the Board credited Dr. Pennell and Dr. Coates in
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`confirming that “even if iron were present in the heart, this does not conclusively
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`[i.e., inevitably] establish that a patient has cardiac disease.” (Decision at 23
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`6
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`(citing Ex. 2001 at ¶ 59).) Notably, even “Dr. Olivieri never ascribes abnormal
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`TRT values to a pathological condition, or so much as mentions cardiac disease
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`(i.e., an iron overload condition of the heart)” in Olivieri Abstract 1995.
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`(Preliminary Response at 43.) Instead, Olivieri Abstract 1995 merely states—as
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`quoted by the Board—“MRI demonstrates changes consistent with reduction in
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`cardiac iron in [deferiprone]-treated pts, in whom baseline T2 relations time (TRT)
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`. . . has increased . . . .” (Decision at 22.)
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`Despite being fully aware that Olivieri Abstract 1995 never explicitly
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`discloses patients having “an iron overload condition of the heart” or “iron-induced
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`cardiac disease,” the Board nonetheless instituted trial on the basis of inherent
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`anticipation thereby committing legal error in at least three respects. First,
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`although the Federal Circuit has made clear that inherency cannot be established
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`based on “probabilities or possibilities,” the Board improperly based its conclusion
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`on the notion that abnormal TRT values indicate high cardiac iron, which in turn
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`indicates cardiac disease. (Decision at 24.) However, as explained above, the
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`presence of cardiac iron does not inevitably indicate an iron overload condition of
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`the heart. Montgomery, 677 F.3d at 1384. The mere possibility, or even
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`probability, that patients with cardiac iron might also have an iron overload
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`condition of the heart or iron-induced cardiac disease is not sufficient to establish
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`inherency under the Federal Circuit standard. In re Robertson, 169 F.3d at 745;
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`7
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`see also Montgomery, 677 F.3d at 1384 (“inherency does not follow even from a
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`very high likelihood that a prior art method will result in the claimed invention.”)
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`Second, the Board committed legal error when it based its assumptions on
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`unsubstantiated testimony from Dr. Mehta. (Decision at 22-24.) For example, the
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`Board relies on Dr. Mehta for the notion that “the reduced T2 relaxation time data
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`in Olivieri Abstract 1995 is evidence that patients were experiencing an iron
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`overload condition of the heart . . . .” (Id. at 24, citing Ex. 1002 at ¶ 75.)
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`However, Dr. Mehta’s statement that “lower TRT values indicate cardiac disease
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`due to iron overload” (see Ex. 1002 at ¶ 75) is not based on any underlying fact or
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`data, but instead is mere conjecture. Indeed, Dr. Mehta’s sole support for this
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`statement is citation to Olivieri Abstract 1995, but the patients discussed therein
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`were never disclosed as having cardiac disease, heart disease, or even an iron
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`overload condition of the heart. Nor does Olivieri Abstract 1995 ever directly
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`equate “lower TRT values” with “cardiac disease.” (See Ex. 1010; Preliminary
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`Response at 43.) Further, Dr. Mehta similarly fails to provide any factual support
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`for his assertion that “patients who were treated with deferiprone in Olivieri
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`Abstract 1995, with low TRT values, had iron overload condition of the heart.”
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`(Ex. 1002 at ¶ 75.) Accordingly, the Board should have assigned Dr. Mehta’s
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`testimony little or no weight. 37 C.F.R. § 42.65(a); see also Office Patent Trial
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`Practice Guide, 77 Fed. Reg. at 48,763 (Aug. 14, 2012) (“Affidavits expressing an
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`8
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`opinion of an expert must disclose the underlying facts or data upon which the
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`opinion is based.”)
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`Third, the Board appeared to improperly shift the burden of proof by stating
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`that “although [Patent Owner’s] Declarants criticize the data, they provide no
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`evidence rebutting the finding in Olivieri Abstract 1995 that particular patients
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`being treated with deferiprone . . . were not experiencing an iron overload
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`condition of the heart.” (Decision at 24.) This is legal error. The proper focus is
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`not whether the Patent Owner, and its Declarants, provided evidence rebutting that
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`Olivieri Abstract 1995 taught patients having an iron overload condition of the
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`heart (which, to be clear Patent Owner did (see Preliminary Response at 43-44)),
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`but whether Petitioner came forth with evidence sufficient to demonstrate this
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`limitation was disclosed in Olivieri Abstract 1995. See, e.g., Coalition For
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`Affordable Drugs VI, LLC v. Celgene Corp., Case IPR2015-01096, -01102, -01103
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`(Sept. 8, 2017) (Paper 78) (Granting a Request for Rehearing and noting, inter alia,
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`that “the proper focus is not on whether the Patent Owner disputed the fact, but
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`whether Petitioner came forward with evidence sufficient to demonstrate”
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`disclosures in the field.) In this case, Petitioner has not made a threshold showing
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`that Olivieri Abstract 1995 taught the treatment of patients having an iron overload
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`condition of the heart (see Preliminary Response at 42-46)—and the Board
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`improperly applied the inherency standard and relied on unsubstantiated testimony
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`9
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`from Dr. Mehta in finding otherwise.
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`Accordingly, Patent Owner requests that the decision to institute on claims
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`1, 2, 4-11, 13-17, 19 as anticipated by Olivieri Abstract 1995 be withdrawn and the
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`ground denied.
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`3.
`
`The Board Misapplied the Law Governing Inherency in the
`Analysis of Olivieri 1995
`The decision to institute on anticipation by Olivieri 1995 rests on a finding
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`that “at least the ten patients discussed in Olivieri 1995 [had] iron levels
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`‘associated with an increased risk of cardiac disease and early death’” which
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`“necessarily satisf[ies] the requirement for having ‘an iron overload condition of
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`the heart’ or ‘iron-induced cardiac disease’ . . . .” (Decision at 30.) However,
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`much like Olivieri Abstract 1995 and Hoffbrand 1998, Olivieri 1995 never
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`explicitly discloses patients having “an iron overload condition of the heart” or
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`“iron-induced cardiac disease.” Accordingly, the finding that Olivieri 1995
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`discloses this limitation again relies on inherency stemming from the assumption
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`that patients with hepatic iron stores at “levels associated with an increased risk of
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`cardiac disease and early death” necessarily had “an iron overload condition of the
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`heart” or “iron-induced cardiac disease.” (Id.) This assumption, however, is
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`insufficient to meet the legal requirements for inherency. As discussed above,
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`inherency “may not be established by probabilities or possibilities.” In re
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`10
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`
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`Robertson, 169 F.3d at 745. Instead, “[t]he keystone of the inherency doctrine is
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`inevitability.” Montgomery, 677 F.3d at 1384; see also Agilent Tech., 567 F.3d at
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`1383 (citing In re Oelrich, 666 F.2d at 581).
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`Olivieri 1995 merely discloses the treatment of ten patients who had hepatic
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`iron stores at levels “associated with an increased risk” of cardiac disease, but
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`Olivieri 1995 never characterized any patient as actually having “an iron overload
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`condition of the heart” or “iron-induced cardiac disease,” a disclosure that neither
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`Petitioner nor Dr. Mehta relied upon in alleging inherent anticipation. The Board
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`nonetheless instituted trial based on inherent anticipation, and in doing so
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`committed legal error. Patients having an increased risk of cardiac disease does
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`not and cannot establish the required inevitability that the patients in Olivieri 1995
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`had cardiac disease. Montgomery, 677 F.3d at 1384 (“inherency does not follow
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`even from a very high likelihood that a prior art method will result in the claimed
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`invention.”).
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`Further, while Olivieri 1995 discloses that “[t]wo patients with insulin-
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`dependent diabetes had cardiac disease” (see Decision at 29, citing Ex. 1012 at
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`918), the Board never relies on this disclosure in its inherency analysis over
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`Olivieri 1995. However, even if the Board had relied on this disclosure, it still
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`would not establish inherent anticipation by Olivieri 1995. As explained in Patent
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`Owner’s Preliminary Response, “Olivieri 1995 does not state that the cardiac
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`11
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`disease observed in these two patients was iron induced.” (Preliminary Response
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`at 50 (emphasis in original).) And, as Dr. Coates explained: “it is entirely possible
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`that the cardiac disease in these two individuals was a result of diabetes, and not
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`iron overload.” (Id. at 50-51, citing Ex. 2001 at ¶ 74.) Thus, because the etiology
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`of the cardiac disease in these two patients is unknown, and could reasonably stem
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`from diabetic complications rather than iron overload, it is not inevitable that these
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`two patients have “an iron overload condition of the heart” or “iron-induced
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`cardiac disease.” Thus, the facts of record do not provide sufficient evidence upon
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`which the Board made its inherent anticipation finding.
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`Accordingly, Patent Owner requests that the decision to institute on claims
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`1, 2, 4-11, 13-17, and 19 as anticipated by Olivieri 1995 be withdrawn and the
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`ground denied.
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`B.
`
`The Board Misapplied the Law Governing Inherency in its
`Obviousness Analysis
`As discussed above, see supra Section III.A., the Board misapplied the law
`
`governing inherency when it concluded that Hoffbrand 1998, Olivieri Abstract
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`1995, and Olivieri 1995 each disclosed patients having an iron overload condition
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`of the heart or iron-induced cardiac disease, and thus anticipate claims 1, 2, 4-11,
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`13-17, and 19. Applying the same erroneous assumptions from its inherent
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`anticipation analysis, the Board likewise found in its obviousness analysis that
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`12
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`“these three references [i.e., Hoffbrand 1998, Olivieri Abstract 1995, and Olivieri
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`1995] identify patients with levels of iron consistent with iron overload conditions
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`of the heart . . . .” (Decision at 35.) For the same reasons as discussed above, the
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`Petitioner has not made a threshold showing that each of these three references
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`teach patients having an iron overload condition of the heart or iron-induced
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`cardiac disease, and the Board improperly applied the inherency standard when it
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`found otherwise.
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`Accordingly, for at least this reason, Patent Owner requests that the decision
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`to institute on claims 1, 2, 4-17, and 19 as obvious in view of each of Hoffbrand
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`1998, Olivieri Abstract 1995, and Olivieri 1995, in combination with the
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`knowledge of the ordinary artisans, be withdrawn and the grounds denied.
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`IV. CONCLUSION
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`For the foregoing reasons, Patent Owner requests that the decision to
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`institute on claims 1, 2, 4-11, 13-17, and 19 as anticipated by Hoffbrand 1998,
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`Olivieri Abstract 1995, and Olivieri 1995, and the decision to institute on claims 1,
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`2, 4-17, and 19 as obvious in view of these same references, in combination with
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`the knowledge of the ordinary artisans, be withdrawn and the grounds denied.
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`Patent Owner further requests that the Board decline to institute Inter Partes
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`Review of the ’328 patent.
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`Date: December 12, 2017
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`IPR2017-01446
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` Respectfully submitted,
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` By: W. Blake Coblentz
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`W. Blake Coblentz
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`Reg. No. 57,104
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`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, D.C. 20036
`(202) 912-4837
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`14
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`Case IPR2017-01446
`U.S. Patent No. 7,049,328
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`CERTIFICATE OF SERVICE
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`I hereby certify that on December 12, 2017, I caused a true and correct copy
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`of Patent Owner Apotex Technologies, Inc.’s Request For Rehearing Under
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`37 C.F.R. § 42.71(c) to be served via electronic mail on the following attorneys of
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`record:
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`Huiya Wu
`Sarah Fink
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`HWu@goodwin.law.com
`SFink@goodwinlaw.com
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`Date: December 12, 2017
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`/s/ W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
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