`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`Thermo Fisher Scientific Inc.
`Petitioner,
`v.
`
`Bio-Rad Laboratories, Inc.
`Patent Owner.
`____________________
`IPR2017-00054
`U.S. Patent No. 8,236,504
`_____________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE TO PETITION FOR
`INTER PARTES REVIEW UNDER 35 U.S.C. § 313 AND 37 C.F.R. § 42.107
`
`
`Agilent Exhibit 1248
`Page 1 of 41
`
`

`

`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`
`TABLE OF CONTENTS
`
`V.
`
`B.
`
`Table of Authorities ................................................................................................. iii
`Table of Abbreviations............................................................................................... v
`I.
`Introduction ...................................................................................................... 1
`II.
`The Claimed Invention .................................................................................... 3
`III.
`Person of Ordinary Skill in the Art .................................................................. 6
`IV. Claim Construction .......................................................................................... 6
`“Heating Element” And “Heater” ......................................................... 6
`A.
`“Wells” .................................................................................................. 9
`B.
`Thermo Fisher’s Invalidity Grounds Fail ...................................................... 11
`Kordunsky Cannot Anticipate The Challenged Claims Or Be Used
`A.
`To Render Them Obvious (Grounds 1 And 2).................................... 11
`1.
`The Challenged Claims Do Not Lack Written Description ...... 11
`2.
`Kordunsky Is Not Prior Art ....................................................... 21
`Li Does Not Render Claims 1-3, 6-7, 9, 13-14, 16 And 19-22
`Obvious (Ground 3) ............................................................................ 21
`1.
`Relevant Case Law.................................................................... 21
`2.
`Li Does Not Teach Or Suggest Essential Claim Limitations ... 22
`3.
`There Was No Suggestion Or Motivation To Modify Li ......... 25
`Li And Heffelfinger Do Not Render Dependent Claims 8, 10 And 15
`Obvious (Ground 4) ............................................................................ 27
`Li And Miller Do Not Render Dependent Claims 11 And 17 Obvious
`(Ground 5) ........................................................................................... 28
`VI. Supporting Evidence ...................................................................................... 30
`Bio-Rad Does Not Submit A Declaration ........................................... 30
`A.
`Petitioner’s Declaration Should Be Disregarded ................................ 31
`B.
`VII. Conclusion ..................................................................................................... 33
`Certificate Of Compliance With Type-Volume Limitation ..................................... 34
`
`C.
`
`D.
`
`
`
`Agilent Exhibit 1248
`Page 2 of 41
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`

`

`
`Certificate Of Service............................................................................................... 35
`
`
`
`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`- ii -
`
`Agilent Exhibit 1248
`Page 3 of 41
`
`

`

`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`TABLE OF AUTHORITIES
`
`Page
`
`
`
`CASES
`
`10X Genomics, Inc. v. Univ. Chicago,
`No. IPR2015-01158 (P.T.A.B. Nov. 16, 2015) .................................................. 32
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) .......................................................................... 13
`
`ATopTech, Inc. v. Synopsys, Inc.,
`No. IPR2014-01153 (P.T.A.B. Jan. 21, 2015) .................................................... 33
`
`Bos. Scientific Corp. v. Johnson & Johnson,
`647 F.3d 1353 (Fed. Cir. 2011) .................................................................... 12, 16
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) .......................................................... 22, 27, 28, 29
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ...................................................................... 22, 28
`
`In re Royka,
`490 F.2d 981 (C.C.P.A. 1974) .......................................................... 22, 25, 27, 29
`
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ...................................................................... 12, 20
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`
`LizardTech, Inc. v. Earth Resource Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) .......................................................................... 13
`
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) .......................................................................... 13
`
`- iii -
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`Agilent Exhibit 1248
`Page 4 of 41
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`

`

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`Multiform Desiccants, Inc. v. Medzam, Ltd.,
`133 F.3d 1473 (Fed. Cir. 1998) ............................................................................ 9
`
`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 21
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ........................................................................ 8, 9
`
`TRW Automotive US LLC v. Magna Elecs. Inc.,
`No. IPR2014-00257 (P.T.A.B. Apr. 8, 2013) ..................................................... 32
`
`
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 103 ........................................................................................................ 22
`
`35 U.S.C. § 314(a) ............................................................................................... 1, 11
`
`37 C.F.R. § 42.108 ............................................................................................. 11, 30
`
`81 Fed. Reg. 18750 (Apr. 1, 2016) .......................................................................... 30
`
`
`
`
`
`- iv -
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`Agilent Exhibit 1248
`Page 5 of 41
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`

`

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`
`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`TABLE OF ABBREVIATIONS
`
`Abbreviation
`
`Explanation
`
`504 [patent]
`
`U.S. Patent No. 8,236,504 (Ex. 1001)
`
`521 [application]
`
`U.S. Patent Application No. 12/827,521
`
`642 [application]
`
`U.S. Patent Application No. 11/555,642 (Ex. 1007)
`
`708 [application]
`
`U.S. Patent Application No. 10/431,708 (Ex. 1031)
`
`Bio-Rad
`
`Bio-Rad Laboratories, Inc. (owner of the 504 patent)
`
`Heffelfinger
`
`U.S. Patent No. 6,043,506 (Ex. 1015)
`
`Kordunsky
`
`Li
`
`Miller
`
`Pet. __
`
`POSA
`
`International Patent Application Publ. No. WO 2004/104547
`(Ex. 1009)
`Translation of Chinese Patent Application Publ. No. CN
`1379236A (Ex. 1006)
`U.S. Patent No. 5,528,050 (Ex. 1029)
`
`Refers to indicated page of Thermo Fisher’s Petition for Inter
`Partes Review
`person of ordinary skill in the art
`
`Thermo Fisher
`
`Thermo Fisher Scientific Inc. (petitioner)
`
`__:__
`
`Ex. __
`
`Refers to the indicated column: line(s) of the indicated
`reference
`Refers to the indicated exhibit
`
`- v -
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`Agilent Exhibit 1248
`Page 6 of 41
`
`

`

`I.
`
`INTRODUCTION
`
`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`
`Thermo Fisher seeks review of claims 1-3, 6-11, 13-17 and 19-22 (the
`
`“challenged claims”) of the 504 patent, which relate to fluorescence detection and
`
`thermal cycler apparatuses.1 Thermo Fisher’s petition fails to establish a
`
`reasonable likelihood of prevailing on any claim under 35 U.S.C. § 314(a), and
`
`thus the Board should decline to institute trial on the 504 patent.
`
`Thermo Fisher raises five grounds of unpatentability. Ground 1 argues that
`
`independent claims 1 and 13 and dependent claims 2-3, 6-11, 14-17, 19-20 and 22
`
`are anticipated by Kordunsky. Ground 2 argues that dependent claim 21 is
`
`rendered obvious by the combination of Kordunsky and Li. Grounds 3-5 rely on
`
`Li as the only or primary reference.
`
`Kordunsky is the publication of the international patent application in Bio-
`
`Rad’s 504 patent family. Kordunsky’s specification is identical in substance to the
`
`specification of the 504 patent. Further, the specifications of both Kordunsky and
`
`the 504 patent are identical in substance to the specification of the 708 application,
`
`which is the earliest filed application in the priority claim of both the 504 patent
`
`and Kordunsky. Nevertheless, Thermo Fisher argues that Kordunsky – which
`
`published after the effective filing date of the 504 patent – is prior art, arguing that
`
`
`1 A Table of Abbreviations is provided at page v.
`
`
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`Agilent Exhibit 1248
`Page 7 of 41
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`

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`the challenged claims lack written description support in the 504 patent
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
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`specification and only are entitled to the claims’ actual filing date of June 30, 2010.
`
`Pet. 6-14. This argument lacks merit.
`
`Skilled artisans would have understood that each limitation of the challenged
`
`claims finds written description support in the specification of the 504 patent and
`
`would not have questioned whether the challenged claims are entitled to their
`
`earliest claimed priority date. Therefore, grounds 1 and 2, relying on Kordunsky,
`
`fail.
`
`Ground 3 argues that independent claims 1 and 13 and dependent claims 2-3,
`
`6-7, 9, 14, 16 and 19-22 are obvious over Li. Ground 4 argues that dependent
`
`claims 8, 10 and 15 are obvious over the combination of Li and Heffelfinger.
`
`Finally, ground 5 argues that dependent claims 11 and 17 are rendered obvious by
`
`the combination of Li and Miller.
`
`Li suffers several fatal flaws. The apparatus disclosed in Li does not contain
`
`essential components of the apparatuses of the challenged claims. Li fails to teach
`
`or suggest that the missing limitations can be integrated into its apparatus. Further,
`
`even if, for some reason, a POSA modified Li to comprise the missing
`
`components, Li’s apparatus would not function in the manner intended.
`
`Accordingly, a POSA at the time of the 504 patent’s priority date in 2003 would
`
`have derived no motivation from Li to arrive at the invention of the challenged
`
`- 2 -
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`Agilent Exhibit 1248
`Page 8 of 41
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`

`

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`claims. Neither Heffelfinger nor Miller cures the deficiencies of Li. Therefore, the
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`grounds of invalidity relying on these references suffer from the same deficiencies
`
`as ground 3, which relies on Li alone. Grounds 4 and 5 also fail because Thermo
`
`Fisher has failed to adequately establish why a POSA would have been motivated
`
`to modify Li with Heffelfinger or Miller at all, let alone with a reasonable
`
`expectation of success in doing so.2
`
`II. THE CLAIMED INVENTION
`
`Independent claim 1 of the 504 patent (reproduced below) is directed to a
`
`fluorescence detection apparatus. Challenged claims 2-3 and 6-11 depend from
`
`claim 1. The apparatus of claim 1 can be attached to a thermal cycler and used to
`
`analyze samples in the thermal cycler’s wells. The apparatus contains, inter alia, a
`
`movable detection module that comprises an excitation light generator (light
`
`source) and a light detector disposed within a common housing. When attached to
`
`
`2 The 504 patent’s European counterpart (EP1620572B1), which contains claims
`
`similar to the challenged claims, was subject to an Opposition. The Opposition,
`
`which raised thirteen different prior art references in an attempt to demonstrate
`
`lack of novelty and inventive step, was rejected and validity of EP1620572B1 was
`
`upheld after an appeal by the anonymous challenger to the Boards of Appeal of the
`
`European Patent Office.
`
`- 3 -
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`Agilent Exhibit 1248
`Page 9 of 41
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`

`

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`a thermal cycler, a lid heater (referred to in claim 1 as a heating element) with
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`holes/opening is disposed between the detection module and the wells of the
`
`thermal cycler. The fluorescence detection apparatus is able to communicate with
`
`samples in the sample wells through the lid heater.
`
`504 Patent Claim 1
`A fluorescence detection apparatus for analyzing samples located in a
`plurality of wells in a thermal cycler, the apparatus comprising:
`a support structure attachable to the thermal cycler;
`a shuttle movably mounted on the support structure; and
`a detection module attached to the shuttle, the detection module
`including:
`
`a housing having an opening oriented toward the plurality of wells;
`an excitation light generator disposed within the housing; and
`an emission light detector disposed within the housing,
`wherein, when the support structure is attached to the thermal cycler, a
`heating element is disposed between the detection module and the sample wells
`and the shuttle is movable to position the detection module in optical
`communication with different wells of the plurality of wells through a plurality
`of openings extending through the heating element.
`
`Independent claim 13 of the 504 patent (reproduced below) is directed to a
`
`thermal cycler apparatus. Challenged claims 14-17 and 19-22 depend from claim
`
`13. The apparatus of claim 13 comprises, inter alia, a thermal cycler comprising
`
`sample wells, a lid heater (referred to in claim 13 as a heater) with holes/openings
`
`(referred to in claim 13 as transparent portions), and a movable detection module
`
`that comprises a light source and a light detector disposed within a common
`
`housing. The lid heater is positioned between the detection module and the wells,
`
`- 4 -
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`Agilent Exhibit 1248
`Page 10 of 41
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`

`

`
`such that the detection module is able to communicate with samples in the wells
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
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`through the lid heater.
`
`504 Patent Claim 13
`A thermal cycler apparatus comprising:
`a thermal cycler having an exterior housing and a plurality of sample wells
`for holding reaction vessels;
`a heater to prevent condensation from forming on a surface of the reaction
`vessels when the reaction vessels are in the sample wells, the heater having a
`plurality of transparent portions to permit optical communication with each of the
`plurality sample wells;
`a support structure disposed inside the exterior housing on an opposite side
`of the heater from the sample wells;
`a shuttle movably mounted on the support structure; and
`a detection module attached to the shuttle, the detection module including:
`a module housing having an opening that is oriented toward the
`plurality of sample wells when the thermal cycler is in an operating state;
`an excitation light generator disposed entirely within the module
`housing; and
`an emission light detector disposed entirely within the module
`
`housing;
`wherein, when the thermal cycler is in the operating state, the shuttle is
`movable to position the detection module in optical communication with different
`sample wells of the plurality of sample wells through the transparent portions of
`the heater.
`
`The claimed apparatuses can be used to perform polymerase chain reaction
`
`(PCR), including real-time PCR – which allows monitoring of the amplification of
`
`a targeted DNA molecule during PCR (i.e., in real-time) – and are thus
`
`fundamentally important from a biotechnology perspective. Ex. 1001, 9:40-14:49.
`
`Advantageously, the claimed apparatuses allow for rapid detection of fluorescence
`
`- 5 -
`
`Agilent Exhibit 1248
`Page 11 of 41
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`

`

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`from samples during PCR, e.g., real-time PCT, with minimal cross-talk between
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
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`channels of the detection module. Ex. 1001, 14:41-49.
`
`III. PERSON OF ORDINARY SKILL IN THE ART
`
`For the limited purpose of this Preliminary Response, Bio-Rad does not
`
`contest the level of ordinary skill in the art. Pet. at 3-4.
`
`IV. CLAIM CONSTRUCTION
`
`Bio-Rad disagrees with Thermo Fisher’s proposed constructions, which
`
`ignore the specification of the 504 patent and established case law.
`
`A.
`
`“Heating Element” And “Heater”
`
`Presented in the table below are the parties’ proposed constructions for the
`
`terms “heating element” (claim 1) and “heater” (claim 13). For the reasons
`
`explained herein, the Board should construe the terms at issue in accordance with
`
`Bio-Rad’s proposed construction.
`
`Term (Claim No.) Thermo Fisher Construction Bio-Rad Construction
`Heating Element (1) Something that “includes” but
`Lid Heater as disclosed in
`is not “limited to the ‘lid
`the 504 patent
`heater’ discussed in the ’504
`patent” (Pet. 4)
`Something that “includes” but
`is not “limited to the ‘lid
`heater’ discussed in the ’504
`patent” (Pet. 4)
`
`Lid Heater as disclosed in
`the 504 patent
`
`Heater (13)
`
`
`
`- 6 -
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`Agilent Exhibit 1248
`Page 12 of 41
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`

`

`Claim 1 recites a “heating element” that is “disposed between the detection
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`
`
`module and the sample wells” of the claimed fluorescence detection apparatus.
`
`Claim 1 specifies that the heating element contains a “plurality of openings
`
`extending through” it. Claim 13 recites a “heater” that can “prevent condensation
`
`from forming on a surface of the reaction vessels” when they are in sample wells
`
`of the claimed thermal cycler apparatus. The heater of claim 13 comprises “a
`
`plurality of transparent portions to permit optical communication” between the
`
`detection module of the thermal cycler and the sample wells.
`
`Thermo Fisher argues that the heater of the 504 patent specification that
`
`contains a plurality of openings/transparent portions is a lid heater. Pet. 4. Thermo
`
`Fisher also argues that the terms heating element (claim 1) and heater (claim 13)
`
`should be construed to mean the same thing. Id. However, Thermo Fisher then
`
`states that “under the broadest reasonable interpretation, this heating
`
`element/heater includes but should not be limited to the ‘lid heater’ discussed” in
`
`the 504 patent. Id.
`
`According to Thermo Fisher, the terms “heating element” and “heater”
`
`require a narrow construction because the 504 patent specification, in addition to
`
`disclosing a lid heater, also discusses a sample unit that has a “heating function.”
`
`Id. Thermo Fisher also argues that because claim 21 recites that the detection
`
`module of the thermo cycling apparatus of claim 13 can be positioned below the
`
`- 7 -
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`Agilent Exhibit 1248
`Page 13 of 41
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`

`

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`sample wells of the apparatus, the heater of claim 13 cannot be limited to a lid
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
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`heater. Id.
`
`The specification “is the single best guide to the meaning” of a claim term.
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005). In the same way
`
`that Thermo Fisher has, skilled artisans would have understood that the lid heater
`
`disclosed in the 504 patent specification represents the lone component of the
`
`apparatuses disclosed in the specification that both (i) possesses a heating function
`
`(e.g., to prevent condensation in sample tubes) and (ii) allows the detection module
`
`of the apparatuses to communicate with sample wells in the sample unit (thermal
`
`cycler block) of the apparatuses through it (e.g., via openings/holes in the lid
`
`heater).
`
`Thermo Fisher’s argument regarding disclosure of other heating elements in
`
`the specification is unsound. Pet. 4. Even Thermo Fisher has acknowledged that
`
`those skilled in the art would have understood that only the lid heater of the 504
`
`patent specification meets the functional requirements of the heating element of
`
`claim 1 and the heater of claim 13. Pet. 4. It follows that one skilled in the art,
`
`guided by the specification, would have understood that any heat source disclosed
`
`in the 504 patent specification that does not meet the functional requirements of the
`
`heating element of claim 1 or heater of claim 13 is not a lid heater. This fact also
`
`undercuts Thermo Fisher’s convoluted arguments centered on dependent claim 21:
`
`- 8 -
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`Agilent Exhibit 1248
`Page 14 of 41
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`if the specification clearly describes a lid heater, and if the heating element of
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
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`claim 1 and the heater of claim 13 both align with the specification’s description of
`
`a lid heater, then skilled artisans would have recognized that the heating element
`
`and heater recited in the claims are, in fact, lid heaters. See Phillips, 415 F.3d at
`
`1315 (“‘[t]he best source for understanding a technical term is the specification
`
`from which it arose.’” (quoting Multiform Desiccants, Inc. v. Medzam, Ltd., 133
`
`F.3d 1473, 1478 (Fed. Cir. 1998)). Claim 21 merely allows for inversion of the
`
`components of the apparatus of claim 13, an embodiment that the 504 patent
`
`specification clearly describes. Ex. 1001, 14:55-60.
`
`When properly construed, the heating element of claim 1 and the heater of
`
`claim 13 correspond to the lid heaters disclosed in the 504 patent specification.
`
`B.
`
`“Wells”
`
`Presented in the table below are the parties’ proposed constructions for the
`
`term “wells” recited in claims 1 and 13. For the reasons explained herein, the
`
`Board should construe the term at issue in accordance with Bio-Rad’s proposed
`
`construction.
`
`Term
`
`Wells
`
`Thermo Fisher Construction Bio-Rad Construction
`A depression with a
`“[O]pen-ended wells which
`have a ‘plurality of openings’
`sealed bottom into which
`that are optical holes at the
`a reaction vessel can be
`bottom” (Pet. 6)
`placed
`
`- 9 -
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`Agilent Exhibit 1248
`Page 15 of 41
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`

`

`Thermo Fisher argues that the term “wells” includes “open-ended wells
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`
`
`which have a ‘plurality of openings’ that are optical holes at the bottom.” Pet. 6.
`
`Thermo Fisher states that Figure 6 of the 504 patent “depicts wells (feature 210)
`
`forming a continuous channel with the openings (feature 220) of the heating
`
`element.” Id.
`
`The 504 patent specification discloses that wells form part of the sample unit
`
`of the disclosed apparatuses, and that reaction vessels (e.g., tubes) can be placed in
`
`the wells. Ex. 1001, 4:37-58. The 504 patent specification only depicts wells as
`
`having an open top (into which a reaction vessel, e.g., a tube, can be placed) and a
`
`sealed bottom. Ex. 1001, Figs. 2, 6. This depiction is consistent with the manner
`
`in which the term wells would have been understood by those skilled in the art.
`
`The “continuous channel” in Figure 6, in contrast, is not a well. Skilled
`
`artisans know that a well and a channel are two very different things. Indeed, the
`
`description of Figure 6 in the 504 patent specification makes it clear that wells are
`
`found in the sample unit (thermal cycler), whereas the holes/openings for optical
`
`communication (i.e., the “continuous channels” pointed to by Thermo Fisher)
`
`represented by feature 220 in Figure 6 are found in the lid heater. Ex. 1001, 7:24-
`
`36.
`
`
`
`- 10 -
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`Agilent Exhibit 1248
`Page 16 of 41
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`V. THERMO FISHER’S INVALIDITY GROUNDS FAIL
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`Inter partes review is limited only to those circumstances where “the
`
`information presented in the petition . . . and any response . . . shows that there is a
`
`reasonable likelihood that the petitioner would prevail with respect to at least 1 of
`
`the claims challenged in the petition.” 35 U.S.C. § 314(a); see also 37 C.F.R. §
`
`42.108(c). Thermo Fisher cannot meet this threshold, and thus its petition should
`
`be denied.
`
`A. Kordunsky Cannot Anticipate The Challenged Claims Or Be
`Used To Render Them Obvious (Grounds 1 And 2)
`
`Thermo Fisher’s first and second grounds rely on Kordunsky. Pet. 15-25.
`
`However, Thermo Fisher has not met its heavy burden to prove that the challenged
`
`claims are not entitled to the May 8, 2003 effective filing date of the 504 patent.
`
`Therefore, Kordunsky – a member of Bio-Rad’s 504 patent family with a
`
`disclosure identical to the 504 patent – is not prior art. Accordingly, grounds 1 and
`
`2 fail.
`
`The Challenged Claims Do Not Lack Written Description
`
`1.
`The 504 patent is a continuation of the 642 application, which in turn is a
`
`continuation of the 708 application, which was filed May 8, 2003. The disclosures
`
`of all three cases are identical. Thermo Fisher argues that the challenged claims
`
`lack written description, arguing that the 504 patent specification and its priority
`
`applications only describe an embodiment of the claimed apparatuses that “is
`
`- 11 -
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`Agilent Exhibit 1248
`Page 17 of 41
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`narrower and differs from what is now claimed.” Pet. 6. Thermo Fisher argues
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
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`that two types of claim elements lack support: (i) the terms “heating element” and
`
`“heater” recited in claims 1 and 13, respectively, and (ii) the terms “plurality of
`
`openings” and “plurality of transparent portions” recited in claims 1 and 13,
`
`respectively. Pet. 7-14.
`
`The “PTO has the initial burden of presenting evidence or reasons why
`
`persons skilled in the art would not recognize in the disclosure a description of the
`
`invention defined by the claims.” In re Wertheim, 541 F.2d 257, 263 (C.C.P.A.
`
`1976). Each of the four terms identified by Thermo Fisher was considered by the
`
`Examiner during prosecution of the 521 application. Ex. 1004, pp. 22, 24. The
`
`Examiner did not question whether these terms are supported by the specification.
`
`Rather, a Notice of Allowance issued less than two months after examination of
`
`the challenged claims. Ex. 1004, p. 8. Thermo Fisher’s lack of written description
`
`argument assumes the Patent Office failed to meet its burden.
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`(a) Relevant Case Law
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`Ipsis verbis disclosure is not necessary to satisfy the written description
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`requirement of section 112. In re Wertheim, 541 F.2d. at 265. Instead, a
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`“specification adequately describes an invention when it ‘reasonably conveys to
`
`those skilled in the art that the inventor had possession of the claimed subject
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`matter as of the filing date.’” Bos. Scientific Corp. v. Johnson & Johnson, 647
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`- 12 -
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`Agilent Exhibit 1248
`Page 18 of 41
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`

`

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`F.3d 1353, 1362 (Fed. Cir. 2011) (quoting Ariad Pharms., Inc. v. Eli Lilly & Co.,
`
`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`598 F.3d 1336, 1351 (Fed. Cir. 2010)). Possession may be demonstrated through
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`means such as “words, structures, figures, diagrams, formulas, etc.” Lockwood v.
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`Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). The description need not
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`“spell out every detail of the invention,” as long as it includes enough information
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`for a person skilled in the art to conclude that the inventor possessed the invention.
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`LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346 (Fed. Cir.
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`2005).
`
`(b)
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`“Heating Element” And “Heater”
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`The lid heater of the 504 patent specification corresponds to the heating
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`element of claim 1 and the heater of claim 13. The table below juxtaposes
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`characteristics of the 504 patent specification’s “lid heater”, the “heating element”
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`of claim 1, and the “heater” of claim 13. While the heater terms may vary, the
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`essential description does not. A skilled artisan would not question whether the
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`heating element and the heater of the challenged claims are supported.
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`- 13 -
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`Agilent Exhibit 1248
`Page 19 of 41
`
`

`

`
`
`504 Spec. Lid Heater Heating Element (Cl. 1)
`The heating element is
`Figs. 2 and 6 depict
`“disposed between the
`fluorescence detection
`detection module and the
`apparatuses of the
`sample wells.”
`invention. In both
`
`figures, the lid heater
`204 is depicted between
`the detection module and
`sample wells.
`“Shuttle 232 is movable
`in two dimensions so as
`to position detection
`module 234 in optical
`communication with
`different ones of the
`sample wells 210 in
`sample unit 202 through
`the corresponding holes
`220 in lid heater 204.”
`Ex. 1001, 5:47-51.
`“Lid heater 204 is used
`to control the
`temperature of the
`sample caps [] in order to
`prevent condensation...”
`Ex. 1001, 5:14-17.
`
`The “shuttle is movable
`to position the detection
`module in optical
`communication with
`different wells of the
`plurality of wells through
`a plurality of openings
`extending through the
`heating element.”
`
`
`
`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`Heater (Cl. 13)
`The detection module is
`“on an opposite side of
`the heater from the
`sample wells.”
`
`
`The “shuttle is movable
`to position the detection
`module in optical
`communication with
`different sample wells of
`the plurality of sample
`wells through the
`transparent portions of
`the heater.”
`
`The heater “prevent[s]
`condensation from
`forming on a surface of
`the reaction vessels when
`the reaction vessels are
`in the sample wells.”
`
`Thermo Fisher argues that the challenged claims “broadly cover an
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`apparatus with any heating element or heater,” whereas the specification of the 504
`
`patent “only discusses two structures with a heating function – a thermal cycling
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`block, termed ‘sample unit’ [in the specification], and a ‘lid heater.’” Pet. 7.
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`- 14 -
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`Agilent Exhibit 1248
`Page 20 of 41
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`

`

`Thermo Fisher first devotes several paragraphs to arguments that stress how
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`
`
`and why the sample unit (thermal cycling block) disclosed in the specification does
`
`not satisfy the functional limitations of the “heating element” and “heater” of the
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`challenged claims. Pet. 7-8, 10. However, on this point, Bio-Rad agrees. A plain
`
`reading of the 504 patent claims makes it clear that the “heating element” and
`
`“heater” do not encompass the sample unit (thermal cycling block). Indeed, claim
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`1 recites both of the “structures with a heating function” that Thermo Fisher states
`
`are disclosed in the specification: (i) a thermal cycler containing a plurality of
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`wells (i.e., the sample unit) and (ii) a separate heating element. Claim 1 further
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`provides limitations that demonstrate the heating element is a lid heater. Thus,
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`claim 1 conveys that the two components are mutually exclusive and avoids the
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`confusion that Thermo Fisher argues exists. Similarly, claim 13 recites (i) a
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`thermal cycler and (ii) a separate heater.
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`One skilled in the art thus would have understood that because the heating
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`element of claim 1 and the heater of claim 13 possess the specific features of the
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`lid heaters disclosed in the specification, the heating element and heater serve the
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`purpose of the lid heaters identified in the 504 patent specification, and thus are
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`adequately described in the specification. The challenged claims need not literally
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`recite the term “lid heater” in order for a skilled artisan to make this determination,
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`particularly when, as Thermo Fisher acknowledges, the specification “only
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`- 15 -
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`Agilent Exhibit 1248
`Page 21 of 41
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`

`

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`discusses two structures with a heating function” and the structure that is not a lid
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`Case IPR2017-00054 for
`U.S. Patent No. 8,236,504
`
`heater also is recited in the claims. See Bos. Scientific Corp., 647 F.3d at 1362
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`(written description is satisfied when a specification “reasonably conveys to those
`
`skilled in the art that the inventor had possession of the claimed subject matter as
`
`of the filing date.”).
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`Thermo Fisher next argues that the term “lid heater” has limited scope. Pet.
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`8-11. Thermo Fisher argues that “the term ‘lid heater’ indicates that the heater also
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`serves as a lid”3 because the specification “unequivocally states that when present,
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`the lid heater ‘is in place on the sample unit’ in order to ‘control the temperature of
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`the sample caps’ of reaction tubes and thus ‘prevent condensation … on the caps.”
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`Pet. 9. In reality, the specification states that “[w]hen lid 122 is in place on sample
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`unit 202, supports 224 hold lid heater 204 in position.” Ex. 1001, 5:8-9. Later, in
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`a different sentence, the specification states “[l]id heater 204 is used to control the
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`temperature of the sample caps (or other sealants) of reaction vessels sample wells
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`210, in order to prevent condensation from forming on the caps during thermal
`
`cycling operation.” Ex. 1001, 5:14-17.
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`
`3