UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`Paper No. 10
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`
`
`
`Boehringer Ingelheim International GmbH and
`Boehringer Ingelheim Pharmaceuticals, Inc.
`Petitioner
`
`
`
`v.
`
`Genentech, Inc.
`Biogen Idec, Inc.
`Patent Owners
`___________________
`
`CASE IPR2015-00415
`Patent 7,820,161
`___________________
`
`
`
`GENENTECH, INC.’S AND BIOGEN INC.’S PATENT OWNER
`PRELIMINARY RESPONSE UNDER 37 C.F.R. § 42.107
`
`
`
`
`
`
`
`
`
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1124, Pg. 1
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`

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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION .................................................................................................... 1
`
`BACKGROUND ....................................................................................................... 5
`
`A.
`
`B.
`
`Rituximab With Methotrexate To Treat RA. ............................................. 5
`
`Prosecution History ........................................................................................ 6
`
`III. CLAIM CONSTRUCTION .................................................................................... 7
`
`IV. BOEHRINGER FAILS TO DEMONSTRATE ANY
`REASONABLE LIKELIHOOD OF PREVAILING. ...................................... 8
`
`A.
`
`Boehringer Never Attempts To Explain How Any Particular
`Combination Of References Allegedly Renders Obvious Any
`Claim Of The Patented Invention. .............................................................. 8
`
`1.
`
`2.
`
`3.
`
`Boehringer Nowhere Articulates Any Reason For A
`Skilled Artisan To Have Combined Specific References
`And Arrived At Any Claimed Invention. ...................................... 11
`
`Boehringer Nowhere Articulates Why A Skilled Artisan
`Allegedly Would Have Had A Reasonable Expectation
`Of Success With Respect To Any Of The Proposed
`Combinations. .................................................................................... 17
`
`Boehringer Selectively Cites From References While
`Ignoring Their Teachings As A Whole, Including
`Teachings Away. ................................................................................ 21
`
`a)
`
`b)
`
`Half Of Boehringer’s “Prior Art Combinations” Fail At
`The Outset Because They Rely On The Gryn Letter (Ex.
`1026), Which Is Not A Printed Publication. ............................ 21
`
`The Other Half Of Boehringer’s “Prior Art
`Combinations” Also Fail Because They Rely On The
`Edwards 1998 Hypothesis. ........................................................ 26
`
`(i)
`
`Skilled Artisans Would Not Have
`Combined The Edwards 1998 Hypothesis
`With Other References And Arrived At
`Any Of The Claimed Inventions............................. 26
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`Merck Ex. 1124, Pg. 2
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`(a)
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`(b)
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`(c)
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`Skilled Artisans Would Not Have
`Accepted The Edwards Hypothesis
`Because Its Underlying Premises
`Were Inconsistent With Scientific
`Literature As Of The Priority Date. ............ 28
`
`The Edwards Hypothesis Would
`Have Discouraged Skilled Artisans
`From Combining Any Of The
`References And Arriving At The
`Claimed Inventions. ....................................... 33
`
`Based On The Edwards Hypothesis,
`Skilled Artisans Would Not Have
`Had A Reasonable Expectation Of
`Success In Combining Any Of The
`References And Arriving At The
`Claimed Inventions. ....................................... 35
`
`(ii)
`
`Boehringer Fails To Establish That The
`Differences Between Claim 1 And The
`Edwards 1998 Hypothesis Would Have
`Been Bridged By Combination With Any
`Other References. ...................................................... 36
`
`(a)
`
`Edwards 1998 Hypothesis In View
`Of O’Dell (Ex. 1003) .................................... 36
`
`(b) Edwards 1998 Hypothesis In View
`Of Pincus (Ex. 1008) ..................................... 38
`
`(c)
`
`Edwards 1998 Hypothesis In View
`Of Kalden (Ex. 1020) .................................... 40
`
`(d) Edwards 1998 Hypothesis In View
`Of (O’Dell or Pincus or Kalden) and
`The Rituxan® Label (Ex. 1006) .................. 41
`
`(e)
`
`Edwards 1998 Hypothesis In View
`Of (O’Dell or Pincus or Kalden) and
`Maloney (Ex. 1023) ........................................ 42
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`Merck Ex. 1124, Pg. 3
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`(iii) Boehringer Fails To Establish That The
`Differences Between Claim 2 And The
`Edwards 1998 Hypothesis Would Have
`Been Bridged By Combination With Any
`References. .................................................................. 43
`
`(iv) Boehringer Fails To Establish That The
`Differences Between Claim 3 And The
`Edwards 1998 Hypothesis Would Have
`Been Bridged By Combination With Any
`References ................................................................... 44
`
`(a)
`
`Edwards 1998 Hypothesis In View
`Of Verhoeven (Ex. 1016) ............................. 47
`
`(b) Edwards 1998 Hypothesis In View
`Of Kavanaugh (Ex. 1019)............................. 49
`
`(c)
`
`Edwards 1998 Hypothesis In View
`Of Boers (Ex. 1022) ...................................... 50
`
`(v)
`
`Boehringer Fails To Establish That The
`Differences Between Claim 4 And The
`Edwards 1998 Hypothesis Would Have
`Been Bridged By Combination With Any
`References. .................................................................. 52
`
`(a)
`
`Edwards 1998 Hypothesis In View
`Of (O’Dell or Pincus or Kalden)
`And The Rituxan® Label (Ex. 1006) .......... 52
`
`(b) Edwards 1998 Hypothesis In View
`Of (O’Dell or Pincus or Kalden) and
`Tobinai (Ex. 1013) ......................................... 53
`
`(vi) Boehringer’s “Prior Art Combinations” For
`Claims 5-12 Fail For At Least The Same
`Reasons They Fail For Claims 1-4. ......................... 54
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`Merck Ex. 1124, Pg. 4
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`Boehringer Fails To Rebut The Record Evidence Of Objective
`Indicia Of Non-Obviousness. .................................................................... 54
`
`B.
`
`1.
`
`The Claimed Treatment Addresses A Long-Felt Need
`For A New Way To Treat RA, And Enjoys Significant
`Commercial Success. ........................................................................ 55
`
`2.
`
`The Claimed Treatment Produces Unexpected Results. ............ 56
`
`CONCLUSION........................................................................................................ 60
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`- iv -
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`V.
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`Merck Ex. 1124, Pg. 5
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`TABLE OF AUTHORITIES
`
`Cases
`3d-Matrix, Ltd, v. Menicon Co., LTD,
`IPR2014-00398, Paper 11 (Aug. 1, 2014) ......................................................... 17
`
`A.R.M., Inc. v. Cottingham Agencies,
`IPR2014-00671, Paper 10 (Oct. 3, 2014) .......................................................... 25
`
`Actavis, Inc. v. Research Corp. Techs., Inc.,
`IPR2014-01126, Paper 22 (Jan. 9, 2015) ........................................................... 22
`
`Amgen Inc. v. F. Hoffman-La Roche, Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009) ........................................................................... 17
`
`Apple, Inc. v. ITC,
`725 F.3d 1356 (Fed. Cir. 2013) .................................................................... 54, 55
`
`Atoptech, Inc. v. Synopsys, Inc.,
`IPR2014-01150, Paper 11 (Jan. 21, 2015) .................................................. 46, 53
`
`Callaway Golf Co. v. Acushnet Co.,
`576 F.3d 1331 (Fed. Cir. 2009) ........................................................................... 44
`
`Cheese Sys., Inc. v. Tetra Pak Cheese & Powder Sys., Inc.,
`725 F.3d 1341 (Fed. Cir. 2013) ........................................................................... 12
`
`Cisco Sys., Inc. v. Constellation Techs. LLC,
`IPR2014-01085, Paper 11 (Jan. 9, 2015) .................................................... 22, 25
`
`Cordis Corp. v. Boston Scientific Corp.,
`561 F. 3d 1319 (Fed. Cir. 2009) ............................................................... 2, 23, 24
`
`Eaton Corp. v. Rockwell Int’l Corp.,
`323 F.3d 1332 (Fed. Cir. 2003) ............................................................................. 8
`
`Elan Pharm., Inc. v. Mayo Found.,
`346 F.3d 1051 (Fed. Cir. 2003) ........................................................................... 57
`
`Garrett Corp. v. United States,
`422 F.2d 874 (Ct. Cl. 1970) ................................................................................. 24
`
`
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`Merck Ex. 1124, Pg. 6
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`Case IPR 2015-0415 (Patent 7,820,161)
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`Google v. EveryMD.com,
`IPR2014-00347, Paper 9 (May 22, 2014) .......................................................... 10
`
`HBPSI v. SRAM, LLC,
`IPR2013-00174, Paper 21 (Aug. 12, 2013) ......................................................... 8
`
`In re Bayer,
`568 F.2d 1357 (C.C.P.A. 1978) ........................................................................... 23
`
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ............................................................................. 22
`
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ........................................................................... 59
`
`In re Kollman,
`595 F.2d 48 (C.C.P.A. 1979) ............................................................................... 59
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ........................................................................... 20
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ........................................................................... 54
`
`Naughty Dog, Inc. v. McRO, Inc.,
`IPR2014-00197, Paper 11 (May 28, 2014) ........................................................ 10
`
`Norman Int’l, Inc., v. Hunter Douglas, Inc.,
`IPR2014-01173, Paper 7 (Feb. 10, 2015) .......................................................... 20
`
`Northern Telecom, Inc. v. Datapoint Corp.,
`908 F.2d 931 (Fed. Cir. 1990) ............................................................................. 23
`
`Preemption Devices, Inc. v. Minnesota Mining.,
`732 F.2d 903 (Fed. Cir. 1984) ............................................................................. 25
`
`SRI Int’l, Inv. v. Internet Sec. Sys.,
`511 F.3d 1186 (Fed. Cir. 2008) ................................................................ 2, 22, 24
`
`Tasco, Inc. v. Pagnani,
`IPR2013-00103, Paper 6 (May 23, 2013) .......................................................... 10
`
`TRW Auto. U.S. LLC, v. Magna Elecs., Inc.,
`IPR2014-00293, Paper 21 (Aug. 28, 2014) ....................................................... 10
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`Merck Ex. 1124, Pg. 7
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
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`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .............................................................. 11, 12, 16
`Statutes
`
`35 U.S.C. § 102 ........................................................................................................... 22, 24
`
`35 U.S.C. § 311 .................................................................................................................. 22
`
`35 U.S.C. § 312 .................................................................................................................... 9
`
`37 C.F.R. § 42.104 ......................................................................................................... 7, 9
`
`37 C.F.R. § 42.108 .............................................................................................................. 7
`
`37 C.F.R. § 42.22 .............................................................................................................. 10
`
`37 C.F.R. § 42.65 ....................................................................................................... 46, 53
`
`MPEP § 2128.02 ............................................................................................................... 25
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`Merck Ex. 1124, Pg. 8
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
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`I.
`
`INTRODUCTION
`
`Rheumatoid arthritis (“RA”) is a crippling autoimmune disorder that inflicts
`
`severe joint swelling and pain that worsens into destruction of cartilage and bone,
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`ultimately leading to substantially decreased mobility and other serious handicaps. Ex.
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`1014 at ¶ 5. The prognosis for patients is grim. Even today, there is no cure.
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`Traditional RA therapy used non-steroidal anti-inflammatory drugs (NSAIDs)
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`and sequences of “progressively toxic second-line drugs” referred to as disease-
`
`modifying antirheumatic drugs (“DMARDs”). Ex. 1022 at 309. “[B]oth patients and
`
`physicians [had been] dissatisfied with the long-term results of traditional therapy.” Id.
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`Collaborators Biogen Inc. and Genentech, Inc. departed from this traditional
`
`approach and developed a creative new therapy. They believed that an antibody called
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`rituximab (Rituxan®)—initially developed and FDA approved for treating certain
`
`blood cancers—could be administered as more than one dose and in combination
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`with methotrexate to provide an improved treatment regimen for RA. And they were
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`right. The combination proved to have unexpected synergistic efficacy and became a
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`commercial blockbuster. Both the FDA and its European counterpart approved
`
`treating RA with the combination of rituximab and methotrexate. Worldwide sales of
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`rituximab for use in this approved regimen for RA have since totaled about $7 billion.
`
`Biogen and Genentech obtained U.S. Patent No. 7,820,161 (the “ʼ161 patent”)
`
`for this novel treatment. Boehringer Ingelheim International GmbH and Boehringer
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`Ingelheim Pharmaceuticals, Inc. (collectively “Boehringer”) now request inter partes
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`Merck Ex. 1124, Pg. 9
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`review of the ʼ161 patent, alleging obviousness based on various combinations of
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`references, but without meeting its burden to set forth with particularity the reasons
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`that a skilled artisan allegedly would have combined any specific set of references and
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`done so with an expectation of successfully achieving the claimed invention.
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`Setting aside the dearth of reasoning for any particular combination of
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`references, all of the combinations fail at the outset. They all are based on one of two
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`primary references (both considered by the Patent Office during examination), neither
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`of which can plausibly support an obviousness challenge.
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`The first of these references, the “Gryn Letter” (Ex. 1026), is simply not a
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`printed publication. It is a private letter. Boehringer completely ignores, and offers no
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`evidence to meet, the Federal Circuit’s “printed publication” standard—that the
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`document in question was disseminated or otherwise made available before the
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`priority date such that a skilled artisan, exercising reasonable diligence, could have
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`located it. See SRI Int’l, Inv. v. Internet Sec. Sys., 511 F.3d 1186, 1194 (Fed. Cir. 2008).
`
`Instead, Boehringer argues that the Gryn Letter is a printed publication because it
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`supposedly was sent to a commercial entity without any confidentiality or other
`
`restrictions on use. Although Boehringer offers no evidence showing that the Gryn
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`Letter was actually sent without any expectation of confidentiality, it would make no
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`difference if Boehringer had done so. The Federal Circuit has held that the absence of
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`a legal obligation of confidentiality does not transform a document into a printed
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`publication. See Cordis Corp. v. Boston Scientific Corp., 561 F. 3d 1319, 1335 (Fed. Cir.
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`Merck Ex. 1124, Pg. 10
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`2009). Because Boehringer has failed to meet its burden to show that the Gryn Letter
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`is a “printed publication,” trial cannot be instituted based on combinations that
`
`include the letter.
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`The other primary reference on which Boehringer bases its combinations is
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`“the Edwards 1998 Hypothesis” (Ex. 1025). The hypothesis proposed that it might be
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`possible to cure RA (a disease that still has no known cure) by administering
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`rituximab and/or another agent that targets and kills all B cells in a patient. All of the
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`combinations based on the Edwards 1998 Hypothesis fail because, as detailed in
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`Section IV.A.3.(b)(i)(a) below, this untested hypothesis turned upon three premises,
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`each of which was inconsistent with scientific literature available to skilled artisans as
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`of the priority date. Boehringer offers no evidence that skilled artisans would have
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`accepted this hypothesis notwithstanding the infirmities in its foundations.
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`Moreover, Boehringer fails to show that, even if skilled artisans had accepted
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`the hypothesis, they would have combined its teachings with those of Boehringer’s
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`secondary references and arrived at a treatment coupling rituximab and methotrexate.
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`In fact, the opposite is true: they would have found no reason to administer rituximab
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`with methotrexate. As Edwards himself has explained, it would be “completely
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`illogical” to use rituximab with methotrexate “because the 2 treatments are unrelated,
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`they’re not doing the same thing.” Ex. 2001 at 3. Boehringer articulates no reason that
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`any skilled artisan who might have accepted the hypothesis would have believed that
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`adding methotrexate to rituximab would have any therapeutic value. The hypothesis
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`Merck Ex. 1124, Pg. 11
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`was to kill all B cells as a means of curing RA—and none of Boehringer’s references
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`identifies methotrexate as an agent that kills B cells.
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`Boehringer also never establishes that skilled artisans would have had a
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`reasonable expectation of success in arriving at the claimed inventions by combining
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`the teachings of the hypothesis with other references, despite the infirmities in its
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`underlying premises. The hypothesis itself conceded it was “uncertain” whether
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`rituximab would succeed as an RA treatment. And as discussed above, a skilled artisan
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`who accepted the hypothesis would have anticipated no therapeutic value from
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`adding methotrexate to rituximab. Moreover, out of dozens of DMARDs in the prior
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`art, Boehringer identifies only two as having been successfully combined with
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`methotrexate—while ignoring that many DMARDs had proven unsuccessful in
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`combination with methotrexate. Boehringer offers no theory under which skilled
`
`artisans would have had a reasonable expectation of success for combining a new,
`
`untested RA treatment with methotrexate despite this track record.
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`Simply put, skilled artisans would not have—and in the case of the Gryn Letter,
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`could not have—relied on either of Boehringer’s primary references as of the priority
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`date. Nor would skilled artisans have had reason to combine them with any other
`
`cited references to result in a therapy of rituximab and methotrexate that those skilled
`
`artisans would have reasonably expected to be successful in treating RA. Boehringer
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`therefore cannot establish a prima facie case of obviousness. Boehringer also fails to
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`Merck Ex. 1124, Pg. 12
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`rebut the objective indicia of non-obviousness, including commercial success and
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`evidence of unexpected synergistic results of the inventions.
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`The petition suffers from other fatal flaws as well. Boehringer never bothers to
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`state with particularity any specific grounds for challenging each claim, despite
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`numerous Board decisions enforcing the requirement to do so. It never identifies
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`differences between any claim and any reference, let alone how those differences
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`allegedly would have been bridged by other references. It also does not articulate any
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`reason for a skilled artisan to have combined specific references or to have expected
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`success with any combination in achieving the claimed inventions. Instead, it
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`addresses claim limitations piecemeal, argues against the claims in the abstract, lists
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`references and combinations in a table without explanation, and improperly tries to
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`lay the burden on the Board to surmise some theory of obviousness. The Board
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`repeatedly has declined to institute trial in the face of such deficiencies.
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`Boehringer’s petition for inter partes review does not establish a reasonable
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`likelihood of prevailing with respect to any claim of the ʼ161 patent. The Board
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`should therefore decline to institute trial.
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`II. BACKGROUND
`A. Rituximab With Methotrexate To Treat RA.
`Rituximab is a genetically-engineered monoclonal antibody directed against the
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`CD20 antigen, which is expressed on B-cells. Ex. 1001 at 2:29-31. The FDA first
`
`approved rituximab to treat low-grade non-Hodgkin’s lymphoma (“NHL”), a type of
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`Merck Ex. 1124, Pg. 13
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`blood cancer. Ex. 1006 at 1. Rituximab co-developers Genentech and Biogen also
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`tested rituximab for non-cancer uses, including RA. After clinical trials showed
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`surprising synergistic efficacy using the combination of rituximab and methotrexate in
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`patients with RA, as discussed below in Section IV.B.2, the FDA approved that
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`combined use as a treatment for RA. Ex. 2002 at 18. The ʼ161 patent encompasses
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`this approved use.
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`B.
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`Prosecution History
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`The ʼ161 patent traces its lineage to a provisional application filed on May 7,
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`1999. Ex. 1001 at 1:6-8. Boehringer acknowledges that the claims of the ʼ161 patent
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`are entitled to at least this priority date. Pet. 6. Patent Owners rely upon the same date
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`solely for purposes of this Preliminary Response.
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`During examination, both of the primary references that Boehringer relies on
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`in this IPR—the Edwards 1998 Hypothesis (Ex. 1025) and the Gryn Letter
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`(Ex. 1026)—were discussed at length. Patent Owners overcame all rejections based
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`on these references. See, e.g., Ex. 2003 at 4 (withdrawing obviousness rejections over
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`combinations based on the Edwards 1998 Hypothesis); Ex. 2004 at 6 (withdrawing
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`102(b) rejection over the Gryn Letter). Similarly, Patent Owners overcame
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`Boehringer’s principal argument here—that it would have been obvious to combine
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`rituximab with methotrexate because every new RA drug treatment supposedly would
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`be combined with methotrexate. For example, Patent Owners distinguished various
`
`references that disclosed combining drugs other than rituximab with methotrexate.
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`Merck Ex. 1124, Pg. 14
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`See, e.g., Ex. 1032 at 4-23 (addressing WO98/04281 (Davis), WO95/09652 (Feldman),
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`and O’Dell 1996 [Ex. 1004]). In allowing the issued claims, the Patent Office agreed
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`that these references did not render obvious the claimed combination of rituximab
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`with methotrexate. See Ex. 2003 at 4 (crediting Patent Owners’ evidence and
`
`arguments). The secondary references that Boehringer relies on here—such as O’Dell
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`1997 (Ex. 1003), Pincus (Ex. 1008), and Kalden (Ex. 1020)—also describe combining
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`methotrexate with drugs other than rituximab. In this respect, they are merely
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`cumulative of the references overcome during examination.
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`III. CLAIM CONSTRUCTION
`Instead of focusing on particular claim
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`terms and proposing claim
`
`constructions (as required by 37 C.F.R. § 42.104(b)), Boehringer’s petition briefly
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`comments on the claims of the ʼ161 patent and makes various assertions about what
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`supposedly would be “included” within the broadest reasonable constructions of
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`claims as a whole. Pet. 13-14. Yet Boehringer does not rely on any of these comments
`
`or assertions as a basis for arguing that its cited references teach the subject matter of
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`any claim. Patent Owners agree that the Board need not construe any terms of the
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`ʼ161 patent in addressing the petition under 37 C.F.R. § 42.108, while reserving all
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`rights with respect to any claim construction issues that might arise in the future.
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`Patent Owners do not, however, endorse Boehringer’s comments and
`
`assertions regarding the claims. And given the lack of specificity in the “Claim
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`Construction” section of the petition, Patent Owners do not attempt here to provide
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`Merck Ex. 1124, Pg. 15
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`an exhaustive list of all their disagreements with Boehringer’s characterizations.
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`Nevertheless, Patent Owners note, for example, that Boehringer’s comments
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`ignore—inadvertently or otherwise—the preambles of the claims, which specify that
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`the claims are directed to methods “of treating rheumatoid arthritis in a human.”
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`Ex. 1001 at 29:42-30:44. These preambles provide the antecedent basis for references
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`to “the human” in the bodies of the claims. It is well-established that such use of
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`language in a preamble is limiting. See, e.g., Eaton Corp. v. Rockwell Int’l, 323 F.3d 1332,
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`1339 (Fed. Cir. 2003) (holding that language in a claim preamble is limiting “[w]hen
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`limitations in the body of the claim rely upon and derive antecedent basis from the
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`preamble”); HBPSI v. SRAM, IPR2013-00174, Paper 21 at 13 (Aug. 12, 2013).
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`IV. BOEHRINGER FAILS TO DEMONSTRATE ANY REASONABLE
`LIKELIHOOD OF PREVAILING.
`
`Boehringer relies on alleged obviousness as its sole basis for challenging the
`
`ʼ161 patent. Yet Boehringer never attempts to articulate how any particular
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`combination of references allegedly renders obvious any claim of the patent and fails
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`to rebut the record evidence of objective indicia of non-obviousness.
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`A.
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`Boehringer Never Attempts To Explain How Any Particular
`Combination Of References Allegedly Renders Obvious Any Claim
`Of The Patented Invention.
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`The petition begins by discussing claim limitations in isolation. Pet. 31-42. It
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`next includes a section entitled “Proposed Combinations of Prior Art” that is less
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`than three pages long—including a page-long chart that simply lists, in bullet-point
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`Merck Ex. 1124, Pg. 16
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`Case IPR 2015-0415 (Patent 7,820,161)
`Patent Owner Preliminary Response
`format, various references and combinations of references without any explanation
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`whatsoever. Pet. 42-45. The discussion following this bullet-point chart, amounting to
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`less than two pages, does not specifically address any of the proposed combinations.
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`The petition then goes on to repackage its earlier piecemeal discussion in the form of
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`“Claim Charts” purporting to show “exemplary disclosure in prior art”—once again,
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`without explaining how any of the alleged prior art references fit together. Pet. 45-57.
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`Boehringer nowhere articulates any reason or motivation for a skilled artisan to
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`have combined specific references or why a skilled artisan allegedly would have had
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`any reasonable expectation of success in practicing the claimed inventions. Nor does
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`Boehringer anywhere address any individual claims or any differences between any
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`claim and any reference it cites. Moreover, it selectively relies on alleged teachings
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`from those references while ignoring their teachings as a whole, including statements
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`that teach away from the claimed invention.
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`Boehringer’s petition does not satisfy the requirement that a petitioner identify
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`“with particularity, each claim challenged, the grounds on which the challenge to
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`each claim is based, and the evidence that supports the ground for the challenge to
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`each claim.” 35 U.S.C. § 312(a)(3) (emphasis added). Nor does it comply with the
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`Board’s rules, which place the burden on the petitioner to show “[h]ow the construed
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`claim is unpatentable,” 37 C.F.R. § 42.104(b), and which require the petition to
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`include “a full statement of the reasons for the relief requested, including a detailed
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`explanation of the significance of the evidence including material facts, the
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`Merck Ex. 1124, Pg. 17
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`Case IPR 2015-0415 (Patent 7,820,161)
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`governing law, rules, and precedent.” Tasco, Inc. v. Pagnani, IPR2013-00103, Paper 6 at
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`10 (May 23, 2013) (citing 37 C.F.R. § 42.22(a)(2)) (emphasis added).
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`Failure to satisfy these requirements is fatal to a request for inter partes review.
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`See, e.g., Naughty Dog, Inc. v. McRO, Inc., IPR2014-00197, Paper 11 at 22 (May 28, 2014)
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`(“Petitioner has failed to resolve any differences between the claimed invention and
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`the cited references, identify any specific proposed modifications to the references, or
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`explain persuasively why one skilled in the art would have made any specific
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`modifications to the references relied on in the challenges . . . .”); Tasco, IPR2013-
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`00103, Paper 6 at 11 (“These conclusory allegations are insufficient to meet
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`Petitioner’s burden.”); Google v. EveryMD.com, IPR2014-00347, Paper 9 at 26 (May 22,
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`2014) (declining to institute trial where, as here, “Petitioners’ assertion does not
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`provide an articulated reasoning with rational underpinning to support the conclusion
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`that the claimed invention would have been obvious.”).
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`The Board has repeatedly rejected Boehringer’s strategy of simply identifying
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`combinations without any corresponding explanations and hoping that the Board will
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`institute trial anyway. Petitioners cannot, as Boehringer has done here, “place the
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`burden on [the Board] to sift through the information presented by Petitioners, . . .
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`and identify any differences between the claimed subject matter and the teachings of
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`[the references].” Google, Paper 9 at 25. The Board has made clear it will not “attempt
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`to fit evidence together into a coherent explanation that supports an argument that
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`demonstrates a reasonable likelihood that Petitioner would prevail.” TRW Auto. U.S.
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`Merck Ex. 1124, Pg. 18
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`Case IPR 2015-0415 (Patent 7,820,161)
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`LLC, v. Magna Elecs., Inc., IPR2014-00293, Paper 21 at 5 (Aug. 28, 2014). Boehringer’s
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`petition does not raise evidence that would support such an argument, in any event.
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`Boehringer’s strategy also prejudices Genentech and Biogen. Because
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`Boehringer fails to provide any explanation of how any particular combination of
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`references allegedly renders any claim of the patent obvious, Patent Owners are
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`unfairly left to guess as to the grounds for the challenge. The Board should deny the
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`petition on this ground alone.
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`1.
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`Boehringer Nowhere Articulates Any Reason For A Skilled Artisan
`To Have Combined Specific References And Arrived At Any
`Claimed Invention.
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`Boehringer devotes a substantial portion of the petition to a piecemeal
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`discussion of where various claim limitations allegedly can be found in the relied-upon
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`references. Pet. 31-42. That piecemeal discussion would be insufficient even if
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`Boehringer showed that each limitation could be found in those references. It is well
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`settled that “[o]bviousness requires more than a mere showing that the prior art
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`includes separate references covering each separate limitation in a claim under
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`examination.” Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011).
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`“Rather, obviousness requires the additional showing that a person of ordinary skill at
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`the time of the invention would have selected and combined those prior art elements
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`in the normal course of research and development to yield the claimed invention.” Id.
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`Nowhere does Boehringer articulate any reason a skilled artisan would have
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`combined any specific references based on the state of the art as of the effective filing
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`Merck Ex. 1124, Pg. 19
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`Case IPR 2015-0415 (Patent 7,820,161)
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`date. Instead, it ignores the perspective of skilled artisans at the time and tries to piece
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`together information in the references using the patented inventions as a guide. This
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`is classic hindsight, and it is impermissible. Obviousness “cannot be based on the
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`hindsight combination of components selectively culled from the prior art to fit the
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`parameters of the patented invention.” Cheese Sys., Inc. v. Tetra Pak Cheese & Powder
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`Sys., Inc., 725 F.3d 1341, 1352 (Fed. Cir. 2013); Unigene, 655 F.3d at 1361 (affirming
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`summary judgment of nonobviousness).
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`Instead of addressing any specif