Case IPR2017-00042
`Patent No. 7,585,860
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
`BAYER INTELLECTUAL PROPERTY, GMBH,
`Patent Owner.
`
`
`
`Case No. IPR2017-00042
`Patent No. 7,585,860
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`
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`

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`Case IPR2017-00042
`Patent No. 7,585,860
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`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`
`THE PERSON OF ORDINARY SKILL IN THE ART ................................. 4
`
`
`
`
`
`I.
`
`II.
`
`III. CLAIM CONSTRUCTION ............................................................................ 4
`
`IV. ARGUMENT ................................................................................................... 4
`
`A.
`
`B.
`
`The Petition is Based on a Priority Date of December 24, 1999 .......... 6
`
`The ’111 Publication is Not Prior Art As a Matter of Law .................. 7
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Before November 29, 2000, WIPO Publications of
`International Applications Did Not Qualify As Prior Art
`Under Section 102(e). ................................................................. 8
`
`Subsequent Amendments to Section 102(e) Do Not
`Change the Prior Art Status of WIPO Publications of
`International Applications Filed Before November 29,
`2000. .......................................................................................... 11
`
`The U.S. Patent and Trademark Office Has Confirmed
`that WIPO Publications of International Applications
`Filed Before November 29, 2000 Do Not Have a 102(e)
`Date. .......................................................................................... 16
`
`The Board Has Specifically Held That WIPO
`Publications of International Applications Filed Before
`November 29, 2000 Do Not Have a 102(e) Date. .................... 20
`
`The Petition Improperly Treats the ’111 Publication as a
`“Patent.” .................................................................................... 22
`
`The ’111 Publication’s Reference to a U.S. Provisional
`Application Does Not Make the Publication Prior Art
`Under Section 102(e). ............................................................... 25
`
`C.
`
`The Petition’s Reliance on the ’111 Publication is Fatal to the
`Asserted Ground. ................................................................................. 27
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`Case IPR2017-00042
`Patent No. 7,585,860
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`1.
`
`2.
`
`The Board Routinely Denies Institution of Grounds that
`Rely on References that Are Not Prior Art. .............................. 28
`
`The Petition’s Argument Fundamentally Relies Upon the
`’111 Publication. ....................................................................... 29
`
`V.
`
`CONCLUSION .............................................................................................. 34
`
`
`
`
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`iii
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`
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`TABLE OF AUTHORITIES
`
`
`CASES
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`Case IPR2017-00042
`Patent No. 7,585,860
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`Benitec Biopharma Limited v. Cold Spring Harbor Laboratory,
`IPR2016-00016, Paper 8 (P.T.A.B. March 31, 2016) .................................. 23, 24
`
`Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375
`(Fed. Cir. 2015) ................................................................................................... 24
`
`Eisai Co. v. Dr. Reddy’s Laboratories, Ltd., 533 F.3d 1353
`(Fed. Cir. 2008) ................................................................................................... 30
`
`Garmin International, Inc. v. Cuozzo Speed Technologies, LLC,
`IPR2013-00373, Paper 12 (P.T.A.B. Dec. 18, 2013) ............................. 20, 21, 29
`
`Global Tel*Link Corp. v. Securus Techs., Inc., IPR2014-00810,
`Paper 8 (P.T.A.B. Nov. 26, 2014) ................................................................ 21, 22
`
`In re Giacomini, 612 F.3d 1380 (Fed. Cir. 2010) .............................................. 22, 23
`
`Sequenom, Inc. v. Board of Trustees of the Leland Stanford Junior
`University, IPR2014-00337, Paper 11 (P.T.A.B. July 16, 2014) ....................... 29
`
`ServiceNow, Inc. v. Hewlett-Packard Co., IPR2015-00716, Paper 13
`(P.T.A.B. Aug. 26, 2015) .................................................................................... 28
`
`Square, Inc. v. Unwired Planet, LLC, CBM2014-00156, Paper 11
`(P.T.A.B. Dec. 24, 2014) .................................................................................... 29
`
`Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) .......................................................................... 30
`
`Teva Pharmaceuticals USA, Inc. v. Indivior UK Ltd., IPR2016-00280,
`Paper 23 (P.T.A.B. June 10, 2016) ..................................................................... 29
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 10 (2012) ........................................................................................ 14, 15
`
`35 U.S.C. § 102(e) (pre-AIPA) .................................................................................. 9
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`35 U.S.C. § 102 (2012) ........................................................................................ 9, 14
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`Case IPR2017-00042
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`35 U.S.C. § 374 (pre-AIPA) .............................................................................. 10, 26
`
`35 U.S.C. § 374 (2012) ...................................................................................... 10, 15
`
`American Inventors Protection Act of 1999, Pub. L. No. 106-113,
`113 Stat. 1501A-552 ............................................................................... 12, 15, 23
`
`Intellectual Property and High Technology Technical Amendments,
`Pub. L. No. 107-273, 116 Stat. 1901 (2002) ................................................ 14, 15
`
`Leahy-Smith America Invents Act, Pub. L. 112–29, 125 Stat. 284
`(2011) .................................................................................................................... 8
`
`M.P.E.P. § 706.02 .................................................................................. 17, 18, 19, 27
`
`M.P.E.P. § 2136.03 ...................................................................................... 19, 26, 27
`
`Examination Guidelines for 35 U.S.C. § 102(e), as amended by the
`American Inventors Protection Act of 1999, and further amended
`by the Intellectual Property and High Technology Technical
`Amendments Act of 2002, and 35 U.S.C. § 102(g) (Revised), 1266
`Off. Gaz. Pat. & Trademark Office 43 (2003) .............................................passim
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`Case IPR2017-00042
`Patent No. 7,585,860
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`I.
`
`INTRODUCTION
`
`This proceeding involves a challenge to a patent protecting the chemical
`
`compound rivaroxaban, a life-saving medication that has benefitted many
`
`thousands of patients. Rivaroxaban is the active ingredient in the anticoagulant
`
`therapy XARELTO®, which is used to prevent and treat thromboembolic disorders
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`such as pulmonary embolisms and deep venous thromboses. Ex. 1001 (’860
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`patent) at col. 1, ll. 49-2:10; see also Ex. 2001 (XARELTO® Prescribing
`
`Information). Rivaroxaban does so by inhibiting an enzyme involved in blood clot
`
`formation called Factor Xa. See, e.g., Ex. 1001 at col. 24, ll. 29-36; Ex. 2001 at 1.
`
`XARELTO® was the first orally-available, direct Factor Xa inhibitor to receive
`
`FDA-approval for clinical use, and is indicated “to reduce the risk of stroke and
`
`systemic embolism in patients with nonvalvular atrial fibrillation,” “for the
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`treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the
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`reduction in the risk of recurrence of DVT and of PE” and “for the prophylaxis of
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`DVT, which may lead to PE in patients undergoing knee or hip replacement
`
`surgery.” Ex. 2001 at 1.
`
`Patent Owner’s position on the merits is that rivaroxaban is nonobvious and
`
`that the challenged claims should be upheld as patentable. If this case were to
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`proceed to a trial, Patent Owner Bayer Intellectual Property GmbH (“Bayer”)
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`stands prepared to offer evidence in support of this position. However, it is
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`respectfully submitted that there will be no need for Bayer to do so, as the Petition
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`Case IPR2017-00042
`Patent No. 7,585,860
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`should be denied. It is deficient on its face and fails to establish a reasonable
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`likelihood that Petitioner Mylan would prevail in showing that any challenged
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`claim of U.S. Patent No. 7,585,860 (“the ’860 patent”) is unpatentable.
`
`The Petition asserts a single ground of unpatentability. The ground posits
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`that rivaroxaban would have been obvious as of a priority date of December 24,
`
`1999, and that, as a result, all of the challenged claims are invalid. In doing so, the
`
`ground fundamentally relies upon International Patent Publication No. WO
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`00/39111 (“the ’111 publication”) (Ex. 1009), a World Intellectual Property
`
`Organization (“WIPO”) publication of an international application filed under the
`
`Patent Cooperation Treaty (“PCT”).
`
`Critically, however, the ’111 publication is not prior art in this case as a
`
`matter of law because it is only entitled to a prior art date of July 6, 2000, over six
`
`months after the December 24, 1999 priority date adopted by the Petition. In
`
`arguing that the ’111 publication is prior art, the Petition fundamentally
`
`misunderstands the patent statute as it existed in 1999 and ignores subsequent
`
`legislative action making clear that the ’111 publication is not prior art in this case.
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`The Petition argues that the ’111 publication is prior art under 35 U.S.C.
`
`§ 102(e) as of December 23, 1998, because (1) the international application that
`
`published as the ’111 publication was filed on December 15, 1999; and (2) that
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`2
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`application refers to a U.S. provisional application filed on December 23, 1998.
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`Pet. at 10-11. That is simply incorrect. It is black-letter patent law that a WIPO
`
`publication of an international application filed before November 29, 2000—the
`
`effective date of the American Inventors Protection Act (“AIPA”)—is only prior
`
`art as of the date that it was actually published, i.e., such publications do not have
`
`an earlier prior art date under Section 102(e). Here, the international application
`
`that led to the ’111 publication was filed before November 29, 2000; as a result,
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`the ’111 publication can only be prior art as of its publication date. That
`
`publication date is July 6, 2000—well after the December 24, 1999 priority date
`
`adopted by the Petition. Accordingly, because the Petition’s only ground relies on
`
`a reference that cannot be used as prior art, the Petition should be rejected and
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`institution should be denied.
`
`Even if the Board were to ignore the ’111 publication and proceed to
`
`consider the remaining references in the proposed ground, the result is the same.
`
`The Petition offers no arguments for unpatentability that do not rely upon the ’111
`
`publication. That is not surprising, as the ’111 publication is central to the
`
`Petition’s arguments. The Petition relies on the ’111 publication not only as a
`
`reason to select the lead compound whose modification would supposedly lead to
`
`rivaroxaban, but also for the motivation to modify that lead compound, in multiple
`
`ways, to arrive at rivaroxaban. Thus, even if the Board were to somehow,
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`improperly in Bayer’s view, simply ignore the ’111 publication and review the
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`Patent No. 7,585,860
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`remainder of the proposed ground, the result would be the same: the Petition
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`should be denied.
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`For all of these reasons, the Board should decline to institute trial.
`
`II. THE PERSON OF ORDINARY SKILL IN THE ART
`For the purpose of this Preliminary Response only, Bayer will not contest
`
`the definition of the person of ordinary skill in the art set forth in the Petition, but
`
`reserves the right to do so if trial is instituted. See Pet. at 15-16.
`
`III. CLAIM CONSTRUCTION
`For the purpose of this Preliminary Response only, Bayer will accept the
`
`position set forth in the Petition that no terms of the ’860 patent require
`
`construction, but reserves the right to propose constructions if trial is instituted.
`
`See Pet. at 19-20.
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`IV. ARGUMENT
`
`The Petition is deficient as a matter of law because the single asserted
`
`ground of unpatentability is fundamentally premised upon a reference, the ’111
`
`publication (Ex. 1009), that is not prior art. Specifically, the analysis and
`
`arguments presented in the Petition are based upon a priority date of December 24,
`
`1999, the date on which the German priority application for the ’860 patent was
`
`filed and to which the ’860 patent claims priority. The ’111 publication is not prior
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`art as of this date. Rather, because the ’111 publication is a WIPO publication of
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`Patent No. 7,585,860
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`an international application that was filed prior to November 29, 2000, it is not
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`available as prior art until its publication date—July 6, 2000—which is months
`
`after the relevant date.
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`
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`The Petition asserts that the ’111 publication is entitled to an earlier date
`
`under 35 U.S.C. § 102(e). That is simply wrong. Before November 29, 2000,
`
`Section 102(e) applied only to granted patents, not WIPO publications of
`
`international patent applications. WIPO publications were deemed by statute to be
`
`nothing more than printed publications, as of the date of publication. While
`
`Section 102(e) was subsequently amended as of November 29, 2000, those
`
`amendments did not retroactively change the status of such publications.
`
`Therefore, as a matter of law, a WIPO publication of an international application
`
`from the time period at issue here does not qualify as prior art under
`
`Section 102(e), i.e., the WIPO publication cannot be used to reach back to an
`
`earlier filing date for prior art purposes under Section 102(e). That is fatal to the
`
`Petition, because the Petition presents no argument for unpatentability that does
`
`not depend upon the ’111 publication. Indeed, the Petition could not present any
`
`such argument, as all of its analysis relies heavily on the disclosure of the ’111
`
`publication. The Petition has therefore failed to demonstrate a reasonable
`
`likelihood of success with respect to any challenged claim, and the Board should
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`decline to institute trial.
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`A. The Petition is Based on a Priority Date of December 24, 1999
`There is no dispute that the relevant priority date for the Petition is
`
`December 24, 1999, the filing date of the German priority document to which the
`
`’860 patent claims priority. Pet. at 6. All of the analysis and arguments in the
`
`Petition use this date. For example, the Petition:
`
` frames the inquiry into the scope and content of the prior art as of
`
`December 24, 1999. See Pet. at 20 (section entitled “Background
`
`Knowledge in the Art Prior to December 24, 1999”); id. (“The
`
`background publications below reflect knowledge skilled artisans
`
`would bring to bear in reading the prior art at the time of the
`
`invention, i.e., the earliest claimed German priority date of December
`
`24, 1999 . . . .”);1
`
` uses “prior to December 24, 1999” to define the “relevant time frame”
`
`for the level of ordinary skill in the art. Pet. at 17; and
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`                                                            
`
`1 See also Pet. at 20 (describing the state of the art “[p]rior to December 24,
`
`1999”); id. at 21 (describing the state of the art “[p]rior to December 1999”); id. at
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`27 (asserting that “there remained in 1999 a need for improved anticoagulants”).
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`Patent No. 7,585,860
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` consistently uses a December 1999 date in its explanation of the
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`asserted ground to describe the state of the art and what would have
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`been routine for a person of ordinary skill. See Pet. at 28, 30.
`
`The ’111 Publication is Not Prior Art As a Matter of Law
`
`B.
`Given the December 24, 1999 priority date, the law is clear that the ’111
`
`publication is not prior art.
`
`The ’111 publication (Ex. 1009) is the published version of an international
`
`application under the Patent Cooperation Treaty (PCT/US99/29832). It lists an
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`international filing date of December 15, 1999 and an international publication
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`date of July 6, 2000. Ex. 1009 at cover; Pet. at 10. On its face, the ’111
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`publication also lists, under “Priority Data,” a U.S. Provisional Application, No.
`
`60/113,778 (the “’778 provisional application”) (Ex. 1010), with a filing date of
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`December 23, 1998.
`
`The Petition contends that, under 35 U.S.C. § 102(e), the ’111 publication is
`
`prior art as of December 23, 1998—and thus prior art to the ’860 patent—by virtue
`
`of this priority claim. More specifically, the Petition asserts that the ’111
`
`publication is “entitled to the benefit of the December 23, 1998 priority date of the
`
`’778 application,” purportedly under 35 U.S.C. § 102(e)(2) as it existed pre-AIA.
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`Pet. at 11. That assertion is wrong as a matter of law.
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`The law is clear that WIPO publications of international applications filed
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`Case IPR2017-00042
`Patent No. 7,585,860
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`before November 29, 2000 cannot qualify as prior art under 35 U.S.C. § 102(e).
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`Such publications are prior art as publications only as of the date of their
`
`publication.2 That is, unlike granted patents, such publications have no Section
`
`102(e) date that could make them prior art earlier than their publication date.
`
`Because the publication date of the ’111 publication was July 6, 2000, well after
`
`the December 24, 1999 priority date, it is not prior art.
`
`1.
`
`Before November 29, 2000, WIPO Publications of
`International Applications Did Not Qualify As Prior Art
`Under Section 102(e).
`
`                                                            
`
`2 The Leahy-Smith America Invents Act substantially amended 35 U.S.C. § 102.
`
`But those amendments apply only to patent applications filed after March 16,
`
`2013, well after the ’860 patent issued, and so are inapplicable here. See Pub. L.
`
`112–29, § 3(n)(1), 125 Stat. 284, 293 (2011). Therefore, all references to
`
`Section 102(a) or Section 102(b) contained in this Preliminary Response refer to
`
`the pre-America Invents Act (“pre-AIA”) versions of those statutory provisions.
`
`References to Section 102(e) likewise refer to the pre-AIA version, but where
`
`needed for clarity further specify whether they refer to the version that existed
`
`before the American Inventors Protection Act (“pre-AIPA”), which took effect on
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`November 29, 2000.
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`In order to see the error of the Petition’s ways, it is important to understand
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`Case IPR2017-00042
`Patent No. 7,585,860
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`the history of Section 102(e) over the last 20 years as it relates to published patent
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`applications. Until November 2000—that is, pre-AIPA—35 U.S.C. § 102(e) did
`
`not apply to published applications. Rather, it was only applicable to granted
`
`patents. The statute read:
`
`A person shall be entitled to a patent unless—
`. . .
`(e) The invention was described in a patent granted on an application
`for patent by another filed in the United States before the invention
`thereof by the applicant for patent, or on an international application
`by another who has fulfilled the requirements of paragraphs (1), (2),
`and (4) of section 371(c) of this title before the invention thereof by
`the applicant for patent . . . .
`
`Ex. 2002 (35 U.S.C. § 102(e) (pre-AIPA)) (emphasis added).3 Under this
`
`provision, a patent granted on certain types of applications could serve as prior art
`
`as of the filing date of the application. But 35 U.S.C. § 102(e) contained no
`
`provision applicable to any publication of such an application. As a result,
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`                                                            
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`3 See also Ex. 2003 at 1355 (35 U.S.C. § 102 (2012), right column, second
`
`paragraph from bottom, reporting text of 35 U.S.C. § 102(e) before amendment by
`
`Pub. L. No. 106-113 (the AIPA)); Ex. 2007 at p. 36 (text of “Pre-AIPA § 102(e)”).
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`published patent applications—such as a WIPO publication of an international
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`application—were not prior art under Section 102(e), but rather were only prior art
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`to the extent they otherwise qualified under a different section of Section 102,
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`namely as printed publications under Section 102(a) or (b).
`
`Indeed, WIPO publications of international applications were the subject of
`
`a specific provision of Title 35, which reinforced that Section 102(e) did not apply
`
`to such references. Before November 29, 2000, 35 U.S.C. § 374 explicitly equated
`
`WIPO publications of international applications to printed publications:
`
`The publication under the treaty of an international
`application shall confer no rights and shall have no
`effect under this title other than that of a printed
`publication.
`
`Ex. 2004 (35 U.S.C. § 374 (pre-AIPA)) (emphasis added).4 In other words, by
`
`statute, a WIPO publication of an international application (such as the ’111
`
`publication) was merely a printed publication, prior art only under Section 102(a)
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`                                                            
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`4 See also Ex. 2003 at 1454 (35 U.S.C. § 374 (2012), final paragraph in left column
`
`continuing into right column, reporting text of 35 U.S.C. § 374 before amendment
`
`by Pub. L. No. 106-113 (the AIPA)); Ex. 2007 at p. 36 (text of “Pre-AIPA § 374”).
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`or 102(b) as of the date of its publication. A published international application
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`did not have an earlier prior art date under Section 102(e).
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`2.
`
`Subsequent Amendments to Section 102(e) Do Not Change
`the Prior Art Status of WIPO Publications of International
`Applications Filed Before November 29, 2000.
`
`
`
`Section 102(e) was subsequently amended via the AIPA in a way that
`
`expanded Section 102(e) to include certain published patent applications.
`
`However, these amendments were prospective as applied to the prior-art status of
`
`WIPO publications of international applications, i.e., they do not apply to WIPO
`
`publications of international applications that were filed prior to November 29,
`
`2000. Because the ’111 publication is based on an international application that
`
`was filed December 15, 1999—i.e., prior to November 29, 2000—the pre-AIPA
`
`version of Section 102(e) applies and the reference is not prior art here.
`
`On November 29, 2000, the AIPA (Pub. L. No. 106-113, 113 Stat 1501A-
`
`552 (1999)), broadened 35 U.S.C. § 102(e) to explicitly include publications of
`
`certain patent applications. Specifically, 35 U.S.C. § 102(e) was amended to read
`
`as follows:
`
`A person shall be entitled to a patent unless—
`
`(e) The invention was described in—
`
`(1) an application for patent, published under section 122(b), by
`another filed in the United States before the invention by the applicant
`for patent, except that an international application filed under the
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`treaty defined in section 351(a) shall have the effect under this
`subsection of a national application published under section 122(b)
`only if the international application designating the United States was
`published under Article 21(2)(a) of such a treaty in the English
`language; or
`
`(2) a patent granted on an application for patent by another filed in the
`United States before the invention by the applicant for patent, except
`that a patent shall not be deemed filed in the United States for the
`purposes of this subsection based on the filing of an international
`application filed under the treaty defined in section 351(a) . . . .
`
`Ex. 2005 at p. 602 (AIPA § 4505, 113 Stat. 1501A-565). Section 374 was
`
`amended in parallel.5 The effect of the AIPA amendments was to make published
`
`domestic patent applications prior art in their own right under Section 102(e),
`
`effective as of the date of their filing. The amendments also applied to published
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`                                                            
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`5 Section 374 was amended to state, “The publication under the treaty defined in
`
`section 351(a) of this title, of an international application designating the United
`
`States shall confer the same rights and shall have the same effect under this title as
`
`an application for patent published under section 122(b), except as provided in
`
`sections 102(e) and 154(d) of this title.” Ex. 2005 at p. 603 (AIPA § 4507, 113
`
`Stat. 1501A-567).
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`international applications, when the stated requirements are fulfilled.
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`Critically, however, these provisions of the AIPA, do not apply retroactively
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`to WIPO publications of international applications that were filed before
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`November 29, 2000—i.e., they do not apply to the ’111 publication and
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`retroactively grant it prior art status under Section 102(e).
`
`In 2002, Congress passed the Intellectual Property and High Technology
`
`Technical Amendments Act of 2002, (H.R. 2215) Pub. L. No. 107-273, 116 Stat
`
`1901 (2002) (“Technical Amendments Act”). This statute made clarifying edits to
`
`the AIPA, including to AIPA-amended Sections 102(e) and 374. It also clarified
`
`that the AIPA’s amendments to Section 102(e) do not apply retroactively to WIPO
`
`publications of international applications filed before November 29, 2000.
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`Specifically, it amended the AIPA’s “Effective Date” provision to state:
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`Patents resulting from an international application filed before
`November 29, 2000 and applications published pursuant to section
`122(b) or Article 21(2) of the treaty defined in section 351(a) [i.e.,
`the Patent Cooperation Treaty] resulting from an international
`application filed before November 29, 2000 shall not be effective as
`prior art as of the filing date of the international application;
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`however, such patents shall be effective as prior art in accordance
`with section 102(e) in effect on November 28, 2000.6
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`Case IPR2017-00042
`Patent No. 7,585,860
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`Ex. 2006 at p. 147 (Technical Amendments Act § 13205, 116 Stat. 1903 (emphasis
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`added)).7
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`                                                            
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`6 Congress specified that “such patents shall be effective as prior art in accordance
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`with section 102(e) in effect on November 28, 2000.” Ex. 2006 at p. 138
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`(Technical Amendments Act § 13205, 116 Stat. 1903) (emphasis added). It did not
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`also refer to published patent applications for a simple reason—these were not
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`prior art at all under the version of Section 102(e) in effect on November 28, 2000.
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`7 See also Ex. 2003 at 1356 (35 U.S.C. § 102 (2012), left column, third full section
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`from top, reporting November 29, 2000 as effective date of amendments to Section
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`102 made by Pub. L. No. 106-113 (AIPA) as “set out as a note under section 10 of
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`this title”); id. at 1332 (35 U.S.C. § 10 (2012), bottom of left column into right
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`column, reporting, as a note, the above-quoted text from the Technical
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`Amendments Act); Ex. 2007 at pp. 36-37 (“Effective Date Provisions for the
`
`amendments to § 102(e) and 374, as amended by H.R. 2215 [the Technical
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`Amendments Act].”).
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`The Technical Amendments Act also amended the AIPA to clarify that the
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`Patent No. 7,585,860
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`changes to Section 374 do not apply retroactively. Specifically, it amended the
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`“Effective Date” provision of the AIPA to state that Section 4507 of the AIPA
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`(which amended 35 U.S.C. § 374) “shall be effective as of November 29, 2000,
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`and shall apply only to applications (including international applications
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`designating the United States) filed on or after that date.” Id.8
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`
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`In other words, international applications filed before November 29, 2000
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`are to be evaluated for prior art status based on the versions of Section 102(e) and
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`Section 374 that were in effect when they were filed—that is, pre-AIPA
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`Section 102(e) and pre-AIPA Section 374. Under those provisions, while patents
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`                                                            
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`8 See also Ex. 2005 at pp. 602-03 (AIPA § 4507, 113 Stat. 1501A-565, -566); Ex.
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`2003 at 1454 (35 U.S.C. § 374 (2012), right column, second full section from top,
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`reporting November 29, 2000 as effective date of amendments to Section 374
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`made by Pub. L. No. 106-113 (the AIPA) as “set out as a note under section 10 of
`
`this title”); id. at 1332 (35 U.S.C. § 10 (2012), bottom of left column into right
`
`column, reporting, as a note, the above-quoted text from the Technical
`
`Amendments Act); Ex. 2007 at pp. 36-37 (“Effective Date Provisions for the
`
`amendments to § 102(e) and 374, as amended by H.R. 2215 [the Technical
`
`Amendments Act].”).
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`that are granted on international applications can qualify as prior art under Section
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`102(e), WIPO publications of international applications have no prior art effect
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`other than as printed publications, as of their date of publication.
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`
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`In sum, the law is clear as a matter of statute: for a WIPO publication of an
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`international application that was filed before November 29, 2000, Section 102(e)
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`does not provide it with an earlier date as of which it is deemed prior art. Rather, it
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`is treated as it was prior to the AIPA amendments—as a printed publication as of
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`its publication date.
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`3.
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`The U.S. Patent and Trademark Office Has Confirmed that
`WIPO Publications of International Applications Filed
`Before November 29, 2000 Do Not Have a 102(e) Date.
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`The U.S. Patent and Trademark Office has interpreted these statutes in
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`accordance with their clear text, and issued guidance confirming that a WIPO
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`publication of an international application filed before November 29, 2000 is only
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`prior art as of its date of publication—i.e., it does not qualify as prior art under
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`Section 102(e). Specifically, in January 2003, the USPTO published a Notice in
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`the Official Gazette setting forth examination guidelines that explained the
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`Office’s interpretation of the effect of the AIPA and the 2002 Technical
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`Amendments Act on Sections 102(e) and 374. See Ex. 2007 at p. 35.9 In this
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`Notice, the USPTO concluded as follows:
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`A U.S. or WIPO publication of an international application filed prior
`to November 29, 2000 will have no prior art effect under § 102(e).
`Such publications do, however, have prior art effect under § 102(a) or
`(b) as of their publication dates.
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`Id. (emphasis added). In other words, and contrary to the position taken in the
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`Petition, a WIPO publication of an international application filed prior to
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`November 29, 2000 cannot be used to reach back to an earlier filing date for prior
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`art purposes under Section 102(e).
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`To depict this rule visually, and to assist in the determination of the “35
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`U.S.C. § 102(e) date” of “WIPO publication of International Applications (IAs),”
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`the PTO published a Section 102(e) flowchart, which is included in the Manual of
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`Patent Examining Procedure (“M.P.E.P.”). Ex. 2008 at 700-50, -51 (M.P.E.P.
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`§ 706.02(f)(1).III). The flow chart divides references into three categories:
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`                                                            
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`9 See Ex. 2007 at p. 35 (“This notice sets forth the interpretation by the . . . USPTO
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`. . . of 35 U.S.C. §§ 102(e) and 374, as amended by the American Inventors
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`Protection Act of 1999 . . . and as further amended by the Intellectual Property and
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`High Technology Technical Amendments Act of 2002 . . . .”).
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`(1) U.S. patents; (2) U.S. patent application publications under 35 U.S.C. § 122(b);
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`and (3) WIPO publications of international applications. Id. For WIPO
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`publications of international applications—i.e., the type of reference at issue
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`here—the flowchart asks a single, preliminary question: “Was the [international
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`application] filed on or after November 29, 2000?” Id. at 700-51. If the answer is
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`no, the result is unambiguous: the application has “no § 102(e) date,” id.—i.e., it
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`is not prior art under Section 102(e). Instead, the “[r]eference is prior art as of its
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`publication date under § 102(a) or (b) no matter what the language of the
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`publica