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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`THERMO FISHER SCIENTIFIC INC.
`Petitioner
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`v.
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`Bio-Rad Laboratories, Inc.
`Patent Owner
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`
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`Patent No. 8,236,504
`Issued: August 7, 2012
`Filed: June 30, 2010
`Inventors: Kordunsky et al.
`
`Title: SYSTEMS AND METHODS FOR FLUORESCENCE DETECTION
`WITH A MOVABLE DETECTION MODULE
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`
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`Inter Partes Review No. IPR2017-00054
`_______________
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`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,236,504
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. §§ 42.1-.80, 42.100-.123
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`TABLE OF CONTENTS
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`Statement of the precise relief requested and the reasons therefor (37
`C.F.R. § 42.22(A)) .......................................................................................... 1
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`
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`I.
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`II.
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`Overview ......................................................................................................... 1
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`III. The '504 Patent disclosure and claims ............................................................ 1
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`IV. Person of ordinary skill in the art ................................................................... 3
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`V.
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`Claim construction .......................................................................................... 4
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`VI. Claims 1-3, 6-11, 13-17 and 19-22 are not entitled to priority before
`their actual filing date of June 30, 2010 ......................................................... 6
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`VII.
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`Identification of the challenge (37 C.F.R. § 42.104(b)) ............................... 14
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`VIII. Ground 1: Claims 1-3, 6-11, 13-17, 19, 20 and 22 are anticipated by
`Kordunsky PCT under pre-AIA §102(b) ...................................................... 15
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`IX. Ground 2: Claim 21 would have been obvious over Kordunsky PCT
`under pre-AIA §103(a) in view of Li ........................................................... 24
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`X. Ground 3: Claims 1-3, 6-7, 9, 13-14, 16 and 19-22 would have been
`obvious over Li ............................................................................................. 25
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`XI. Ground 4: Claims 8, 10 and 15 would have been obvious over Li and
`Heffelfinger ................................................................................................... 44
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`XII. Ground 5: Claims 11 and 17 would have been obvious over Li and
`Miller ............................................................................................................ 46
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`XIII. Objective indicia do not support patentability .............................................. 47
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`XIV. Certification that the patent may be contested via inter partes review
`by the Petitioner and Standing (37 C.F.R. § 42.104(a)) ............................... 47
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`XV. Mandatory notices (37 C.F.R. § 42.8(a)(1)) ................................................. 47
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`XVI. Conclusion .................................................................................................... 49
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`I.
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`Statement of the precise relief requested and the reasons therefor (37
`C.F.R. § 42.22(A))
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`Thermo Fisher Scientific Inc. petitions for Inter Partes Review, seeking
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`IPR of USPN 8,236,504
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`cancellation of claims 1-3, 6-11, 13-17 and 19-22 of U.S. Patent No 8,236,504 to
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`Kordunsky et al. ("the '504 Patent") (Ex. 1001), which on its face indicates that the
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`assignee is Bio-Rad Laboratories, Inc. (no assignment have been recorded for this
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`patent). As set forth in detail below, claims 1-3, 6-11, 13-17 and 19-22 are
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`unpatentable for anticipation and obviousness.
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`II. Overview
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`The claims of the '504 Patent should be canceled. They are directed to a
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`thermal cycler with a movable detection module which contains an internal light
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`generator and a detector (hereafter, "optics head"), attached to a shuttle movably
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`mounted on a support, where the optics head views sample wells through openings
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`in a heating element. But these claims merely recite well-known features. For
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`example, the prior art reference "Li" (Ex. 1005, detailed below) teaches or at least
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`suggests such a cycler. Accordingly, each claim of the '504 Patent would have been
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`anticipated or obvious over the prior art as discussed below.
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`III. The '504 Patent disclosure and claims
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`The '504 Patent, entitled "Systems and methods for fluorescence detection
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`with a movable detection module," issued on Aug. 7, 2012, from U.S. App. No.
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`12/827,521, which was filed on Jun. 30, 2010. Ex. 1001. The '504 Patent claims
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`priority to App. No. 11/555,642 filed Nov. 1, 2006, which is a continuation of App.
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`No. 10/431,708, filed May 8, 2003. Id., Ex. 1007; Ex. 1031.
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`The '504 Patent claims. The '504 Patent has 22 claims. Claims 1 and 13 are
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`the only independent claims. Each claim of the '504 Patent requires the presence of
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`a self-contained movable "detection module" ("optics head") which contains both
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`a light generator and a detector within its housing. Claim 1 is exemplary and is
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`provided below:
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`1. A fluorescence detection apparatus for analyzing samples
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`located in a plurality of wells in a thermal cycler, the apparatus
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`comprising:
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`a support structure attachable to the thermal cycler;
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`a shuttle movably mounted on the support structure; and
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`a detection module attached to the shuttle, the detection module
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`including:
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`a housing having an opening oriented toward the plurality of wells;
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`an excitation light generator disposed within the housing; and
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`an emission light detector disposed within the housing,
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`wherein, when the support structure is attached to the thermal
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`cycler, a heating element is disposed between the detection module and
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`the sample wells and the shuttle is movable to position the detection
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`module in optical communication with different wells of the plurality of
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`wells through a plurality of openings extending through the heating
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`element.
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`Independent claim 13 is similar to claim 1, but indicates among other things
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`that the cycler has an "exterior housing." Ex. 1001, claim 13.
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`IV. Person of ordinary skill in the art
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`IPR of USPN 8,236,504
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`A person of ordinary skill in the art ("artisan") is a hypothetical person who
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`is presumed to be aware of all pertinent art, thinks along conventional wisdom in
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`the art, and is a person of ordinary creativity. An artisan in the technical field of the
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`'504 Patent (optical detection devices, including thermal cyclers) would have had
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`knowledge of the scientific literature concerning the design and manufacture of
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`analytical instruments for biological applications, which included optical detection
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`devices and scanning assemblies, including but not limited to thermal cyclers,
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`sequencers, microarray readers, fluorimeters, plate readers and scanners before
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`2003. Ex. 1002, ¶13.
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`With respect to the subject matter of the '504 Patent, an artisan would
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`typically have had (i) an undergraduate degree (e.g., B.Sc. or B.A.) in optics,
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`physics, engineering (e.g., mechanical, electrical or structural), analytical or
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`physical chemistry, chemistry, biology or a related field in the engineering,
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`biological or chemical sciences, and have had at least about one year of experience
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`in the design or manufacture of biological analysis instruments, including optical
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`components for fluorescence detection, for example in thermocyclers and scanners.
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`Also, an artisan may have worked as part of a multidisciplinary team and drawn
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`upon not only his or her own skills, but of others on the team, e.g., to solve a given
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`problem. For example, a physicist, biologist, chemist and/or an optical engineer
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`may have been part of a team. Ex. 1002, ¶14.
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`V. Claim construction
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`In accordance with 37 C.F.R. § 42.100(b), the challenged claims must be
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`given their broadest reasonable interpretations (BRI) in light of the specification
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`and prosecution history of the '504 Patent. Claim terms not discussed below should
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`be construed according to the BRI.
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`Claim 1(h) recites "a heating element" with a plurality of openings, and
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`claim 13(b) recites a "heater" with a plurality of transparent portions, which can be
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`holes (see claim 22). The ‘504 specification only discusses one component which
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`has a plurality of openings or transparent portions - a “lid heater” with “holes.” In
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`particular, “[l]id heater 204 has holes 220 therethrough …and electronically
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`controlled heating elements (not shown).” Ex. 1001, 5:1-3. For purposes of the
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`instant petition only under the broadest reasonable interpretation, the terms
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`"heating element" (claim 1) and "heater" (claim 13) are treated as equivalent.
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`Under the broadest reasonable interpretation, this heating element/heater includes
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`but should not be limited to the "lid heater" discussed in the '504 patent as part of
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`an "exemplary" apparatus. Ex. 1001, 4:7-15, 4:37-66; Ex. 1002, ¶24. The '504
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`Patent discusses two components that have a heating function – namely, a sample
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`unit (i.e., thermal cycling block) and a "lid heater" placed on top of sample tubes.
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`Id. Under the broadest reasonable interpretation, either component could act as a
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`"heating element" (claim 1) or "heater" (claim 13) if it meets all the claim
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`requirements for this element. Claim 21 confirms that the "heater" (claim 13) or
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`"heating element" (claim 1) is not limited to the so-called "lid heater" which is only
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`described as placed on top of wells in the '504 Patent and its parent 11/555,642, as
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`discussed further in Section VI (lack of priority). Ex. 1001, 4:37-39, 5:1-17, Figs.
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`2, 6; Ex. 1002, ¶24. Claim 21 requires that (1) the optics head opening must be
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`below the sample wells and (2) the optics head must view sample wells "through ...
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`the heater." Artisans would have understood that an optics head placed below
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`sample wells as required by claim 21 could not view the wells "through" the lid
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`heater, which is only described as necessarily placed on top of the wells. Ex. 1002,
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`¶24. Thus, artisans would have understood that the "heater" element of claims 13-
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`22, and thus the equivalent "heating element" of claims 1-12, have a broader
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`reasonable interpretation than the lid heater discussed in the '504 Patent, and are
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`not limited to such a lid heater. Ex. 1001, 4:37-39, 5:1-17, Figs. 2, 6; Ex. 1002,
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`¶24.
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`Claims 1 and 13 also recite that the cycler has “wells.” The ‘504 Patent does
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`not define “wells” or otherwise place any constraints upon the exact format of the
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`well. The prior-art reference “Li” applied herein discloses a cycler in which the
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`sample wells have optical holes at the bottom (shown as element 21 in Fig. 3) to
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`allow Li's optics head to view samples through Li's cycling block. Ex. 1006; Ex.
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`1002, ¶25. Under the broadest reasonable interpretation, the term “wells” includes
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`open-ended wells which have a “plurality of openings” that are optical holes at the
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`bottom. Under the broadest reasonable interpretation, the “wells” can be in
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`structural continuity or structural overlap with the openings. Id. Fig. 6 of the '504
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`Patent depicts wells (feature 210) forming a continuous channel with the openings
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`(feature 220) of the heating element, consistent with this interpretation. Ex. 1001,
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`Fig. 6; Ex. 1002, ¶25.
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`VI. Claims 1-3, 6-11, 13-17 and 19-22 are not entitled to priority before
`their actual filing date of June 30, 2010
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`The '504 Patent was filed on June 30, 2010, and claims priority to May 8,
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`2003, as a continuation of App. No. 11/555,642 filed Nov. 1, 2006, which is a
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`continuation of App. No. 10/431,708, filed May 8, 2003.
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`But claims 1-3, 6-11, 13-17 and 19-22 are not entitled to the priority benefit
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`of App. No. 11/555,642 filed Nov. 1, 2006 (hereafter, the "Parent"), and thus are
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`not entitled to any priority before their actual filing date of June 30, 2010. This is
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`because the Parent does not provide a written description of the claimed apparatus
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`that is commensurate with the '504 claims, and only describes a particular
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`embodiment that is narrower and differs from what is now claimed. Lockwood v.
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`Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997).
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`A. The term "heating element" (claim 1) or "heater" (claim 13) lacks
`written description support in the parent
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`All '504 claims recite an apparatus with a "heating element" (claim 1) or
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`"heater" (claim 13). These terms were introduced on March 12, 2012 – nearly two
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`years after the ’504 Patent was filed. The claims require that the heating element is
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`"disposed between the detection module and the sample [unit] wells" (claim 1) or
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`the heater has the sample unit/wells on one side and a support structure with a
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`detection module "on an opposite side" of the heater (claim 13). The claims further
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`specify that the heating element contains a "plurality of openings extending
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`through" it (claim 1) or a "plurality of transparent portions" (claim 13).
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`In contrast to the claims which broadly cover an apparatus with any heating
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`element or heater, the Parent only discusses two structures with a heating function
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`– a thermal cycling block, termed "sample unit" by the Parent, and a "lid heater."
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`Ex. 1007, ¶¶26-32, 51, Figs. 2, 6; Ex. 1002, ¶30. As explained below, the sample
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`unit described in the Parent does not meet the requirements of the claims, and the
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`"lid heater" does not provide commensurate support. Id.; Ex. 1002, ¶30.
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`The cycling block or "sample unit" discussed in the Parent clearly does not
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`match the claimed "heating element" (claim 1) or heater (claim 13). For example,
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`the Parent does not mention that the sample unit has a plurality of holes (claim 1)
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`or transparent portions (claim 13) through which the optics head can view the
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`wells. The Parent only discusses how the sample unit is part of "[l]id assembly
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`112," and can contain "sample wells 210," as well as "heating elements." Id.; Ex.
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`1002, ¶31. The Parent further states that the sample unit "may be of conventional
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`design" and that "the base and sample unit may be designed as an integrated
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`system or separated," and that the optics head "may interrogate sample wells from
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`any direction (e.g., above or below) in accordance with the design of a particular
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`instrument." Id. at 31, 51, 80; Ex. 1002, ¶31. None of these teachings discloses or
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`suggests that the sample unit has openings or transparent portions, or that wells can
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`be viewed through the sample unit as the claims require. Ex. 1002, ¶31.
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`In addition, the sample unit as described by the Parent does not have the
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`placement required by the claims. The claims require the heating element/heater to
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`be placed between the detection module and wells (claim 1) or to be placed
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`between the support and wells (claim 13). But the sample unit discussed by the
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`Parent is under all three structures – the sample wells, detection module and
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`support – and not between them. Ex. 1007, Figs. 2, 3; Ex. 1002, ¶32. Thus, the
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`sample unit does not provide a written description of the claimed "heating element"
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`(claim 1) or "heater" (claim 13).
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`The Parent also discusses an entirely different component within the context
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`of an exemplary cycler apparatus – a "lid heater" – which is a single narrow
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`example of the generic heating element/heater recited in the claims. Ex. 1007,
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`¶¶27-32; Ex. 1002, ¶33. In particular, the Parent does not support broad claims to
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`IPR of USPN 8,236,504
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`any generic heating element or heater since it only discloses a "lid heater" having
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`one particular structure and never suggests that this can be varied in any way.
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`LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346 (Fed. Cir.
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`2005); Augustine Medical, Inc. v. Gaymar Industries, Inc., 181 F.3d 1291, 1303
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`(Fed. Cir. 1999); Ex parte Forest, Appeal No. 2011-003338 (PTAB 2014). Ex.
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`1002, ¶33.
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`Under its plain meaning, the term "lid heater" indicates that the heater also
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`serves as a lid, and this is specifically confirmed in the Parent. The Parent
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`unequivocally states that when present, the lid heater "is in place on the sample
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`unit" in order "to control the temperature of the sample caps" of reaction tubes and
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`thus "prevent condensation … on the caps." Ex. 1007, ¶¶29, 30, Figs. 2, 6; Ex.
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`1002, ¶34. There is no disclosure of a lid heater that is not on top of the sample
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`tubes and in contact with the caps. Consistent with its stated function of heating
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`tube caps, the lid heater is invariably depicted as being directly on top of the
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`sample unit, directly over and in contact with the tube caps, both in figures and
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`words. Id. The Parent treats both the positioning and contact as integral features of
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`the lid heater, not merely optional or even preferable. Id.
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`In contrast, the '504 claims omit any mention of the heater acting as a "lid
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`heater" or otherwise being on top of the sample unit in contact with the caps. This
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`broadening in the '504 claims is a material change, since the '504 claims now cover
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`other different heating elements, such as the thermal cycling block of the Li
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`reference, discussed below, in a manner that was not contemplated by the Parent.
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`The Parent only mentions in passing that the fluorometer assembly, which is
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`described as including the support, shuttle and detection module but not the heating
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`element, can be "adapted ... [to] interrogate sample wells from ... below." Ex. 1007,
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`¶¶ 27, 29, 32, 80; Ex. 1002, ¶35. This narrow disclosure would not have conveyed
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`what is now more broadly claimed. Id.
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`The claims now cover cyclers such as Li's which include new and different
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`types of heating elements, such as Li's perforated cycling block which includes the
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`claimed "openings" to allow wells to be viewed through it. In contrast, the Parent
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`describes the lid heater and the "sample unit"(i.e., cycling block) as two separate
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`components, never suggesting that the sample unit can pass as the claimed heating
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`element. Although the Parent mentions briefly that the fluorometer assembly (not
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`the heater) can be modified to view wells from below, this did not suggest to
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`artisans that the cycling block could be modified to include openings or could
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`otherwise act as the claimed heating element. Ex. 1002, ¶36. The claims now
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`broadly cover new and different heating elements with openings, such as Li's
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`perforated cycling block, that are not supported by discussion of a "lid heater" of
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`the Parent. Ex. 1002, ¶36.
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`The Parent moreover emphasizes the functional importance of heater's
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`placement as a lid on the caps of sample tubes. This positioning allows the lid
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`heater to "control the temperature of the sample caps," and prevent condensation"
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`onto the sample caps." Ex. 1007, ¶¶29, 27; Ex. 1002, ¶37. In short, the Parent's
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`disclosure would have deterred artisans from repositioning the lid heater under the
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`block. Id.
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`Thus, the Parent shows a complete lack of possession of a heater with
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`openings other than a lid heater, or a heater of a non-lid structure that is placed
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`anywhere between the wells and a optics head, as is now claimed. The Parent only
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`contemplates one particular configuration in which a "lid heater" acts as a heated
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`lid for the sample tubes in order to prevent condensation onto the "caps" of sample
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`tubes. Ex. 1007, ¶¶29, 27; Ex. 1002, ¶38. The Parent did not convey to artisans that
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`this particular configuration could be arbitrarily dispensed with, as the '504 claims
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`now do.
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`B.
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`The terms "a plurality of openings" (claim 1) or "a plurality of
`transparent portions" (claim 13) lack written description support
`in the Parent
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`The '504 claims specify that the claimed apparatus comprises a heating
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`element with "a plurality of openings extending through" it (claim 1) or a "heater
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`having a plurality of transparent portions to permit optical communication" with
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`each well (claim 13).
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`The Parent never suggests that the lid heater can have "openings" as claim 1
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`now specifies. The Parent instead explains that the detection module (hereafter,
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`"optics head") has "openings," and that these so-called "openings" in the DM
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`"may simply be holes ... or they may be made of any substance that has a high
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`degree of transparency." Ex. 1007, ¶38; Ex. 1002, ¶40. Thus, the term “openings”
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`is broader than “holes.” The Parent clearly and unambiguously indicates that (1)
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`solid portions made of transparent material (hereafter dubbed "windows") are an
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`alternative to "holes", and (2) the broader term "openings" includes both
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`alternatives: holes and windows. Id.; Ex. 1002, ¶40. The Parent further indicates
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`that whereas the optics head can have openings, by contrast the lid heater only has
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`holes. Specifically, "[l]id heater 204 has holes 220 therethrough, matching the size
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`and spacing of the sample wells 210" and the optics head views wells through
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`"corresponding holes 220 in lid heater." Id. at ¶¶29, 32; Ex. 1002, ¶40. The Parent
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`even refers to the optics head's "openings" and the lid heater's "holes" in the same
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`sentence, reconfirming that the lid heater only has holes, and not openings: in
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`particular, "[o]ptical communication ... is provided by opening 502 in opaque
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`walls 602 [of the optics head] and a hole 220 through lid heater 204." Id. at ¶41;
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`Ex. 1002, ¶40. The Parent's teachings are clear and unambiguous: the optics head
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`has "openings" which can be windows or holes, whereas the lid heater only has
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`holes and does not have "openings" like the optics head does.
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`In stark contrast to the Parent's limited disclosure, the '504 claims cover a
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`"heating element" or "heater" that is broader than the lid heater of the Parent. For
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`example claim 1 now states that the heating element has "openings" – a term which
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`the Parent only uses in reference to the optics head and not the lid heater. Id. at
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`¶¶38-44, claims 1-9; Ex. 1002, ¶41. The possibility of openings on a lid heater
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`instead of holes is a new concept missing from the Parent, since the term
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`"openings" is defined as including windows and unspecified structures in addition
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`to holes. Similarly, claim 13 recites a "heater having a plurality of transparent
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`portions," and dependent claim 21 makes clear that these "transparent portions"
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`can include holes. But the Parent never mentions "transparent portion." Ex. 1002,
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`¶41. Instead, the Parent only mentions openings made of a high-transparency
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`material (i.e., windows) that are not holes. Ex. 1007, ¶38; Ex. 1002, ¶41. Thus, the
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`term "transparent portions" as used in claim 13 (i.e., including holes per dependent
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`claim 22) is not described in the Parent, which only discusses transparent portions
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`that are not holes. Moreover, the Parent only discusses lid heaters with holes, and
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`does not suggest lid heaters with windows as now covered by claim 13. Id. Thus,
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`claim 13 is not adequately supported by the Parent.
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`None of the dependent claims repair the § 112 defects of the base claims. It
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`is noted that dependent claim 22 indicates that the "plurality of transparent portions
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`include a plurality of holes." This claim 22 also lacks § 112 support in the Parent
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`IPR of USPN 8,236,504
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`because its open-ended terminology ("includes") permits its "plurality of
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`transparent portions" to include a subset of windows in addition to a subset of
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`holes. In contrast, the Parent's disclosure is limited to lid heaters that only include
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`holes and not windows. Even if it was obvious to use windows in a lid heater, “a
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`description that merely renders the [claimed] invention obvious does not satisfy the
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`[written description] requirement.” See Ariad Pharmaceuticals, Inc. v. Eli Lilly and
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`Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010).
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`Because the Parent fails to adequately describe the '504 claims, the claims
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`are not entitled to any priority before their actual filing date of June 30, 2010.
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`VII. Identification of the challenge (37 C.F.R. § 42.104(b))
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`Petitioner requests inter partes review of claims of the '504 Patent based on
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`the unpatentability grounds summarized in the index below. Per 37 C.F.R. §
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`42.6(c), copies of the cited references accompany the Petition.
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`Ground
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`35 U.S.C. §
`(pre-3/16/2013)
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`1
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`2
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`3
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`4
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`5
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`§102(b)
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`§103
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`§103
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`§103
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`§103
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`Claims
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`Index of References
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`1-3, 6-11, 13-17,
`19, 20, 22
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`21
`1-3, 6-7, 9, 13,
`14, 16, 19-22
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`Kordunsky PCT
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`Kordunsky PCT and Li
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`Li
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`8, 10, 15
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`Li and Heffelfinger
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`11, 17
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`Li and Miller
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`WO 2004/104547 A2 ("Kordunsky PCT," Ex. 1009) published on Dec. 2,
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`2004, and is prior art under pre-AIA §102(b) under the correct priority date for the
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`IPR of USPN 8,236,504
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`'504 Patent, which is its actual filing date of Jun. 2010. Chinese Patent Publ. No.
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`CN 1379236A ("Li," Ex. 1005) published in Chinese on Nov. 13, 2002, and is
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`prior art under pre-AIA §102(a) under the asserted priority date of May 8, 2003
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`and prior art under pre-AIA §102(b) under the correct priority date of Jun. 2010 for
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`the '504 Patent. U.S. Pat. 6,043,506 ("Heffelfinger," Ex. 1015) published on Mar.
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`28, 2000, and is prior art under pre-AIA §102(b) under the '504 Patent's asserted
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`priority date. U.S. Pat. 5,528,050 ("Miller," Ex. 1029) published on Jun. 18, 1996,
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`and is prior art under pre-AIA §102(b) under the '504 Patent's asserted priority
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`date.
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`Each claim is challenged under two non-redundant Grounds, one based on
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`the Kordunsky PCT as primary reference, and the other on Li. The Grounds are not
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`redundant because Li is §102(a) prior art under the asserted date that renders the
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`claims obvious, whereas the Kordunsky PCT is not prior art under the asserted
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`priority date but forms anticipatory art under the correct priority date. Therefore,
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`the Grounds raise different factual and legal issues, and trial should be instituted on
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`each. This Petition is accompanied by a supporting declaration of Petitioner's
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`technical expert, Professor Richard Mathies.
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`VIII. Ground 1: Claims 1-3, 6-11, 13-17, 19, 20 and 22 are anticipated by
`Kordunsky PCT under pre-AIA §102(b)
`
`As discussed in Section VI above, all '504 claims are not entitled to priority
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`before their actual filing date of June 30, 2010. As a result, the Kordunsky PCT,
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`IPR of USPN 8,236,504
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`which published on Dec. 2, 2004, is prior art under the pre-AIA version of 35
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`U.S.C. § 102(b). Ex. 1009. The Kordunsky PCT contains substantially identical
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`disclosure to both the Parent and the '504 Patent itself and narrowly discusses
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`specific embodiments covered by the broader '504 claims. Although this narrow
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`disclosure fails to provide commensurate priority support in the Parent across the
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`scope of the '504 claims, the same narrow disclosure in the Kordunsky PCT is
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`sufficient to anticipate since it falls within the scope of those claims. See, e.g.,
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`Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997):
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`Chester v. Miller, 906 F.2d 1574, 1575 (Fed. Cir. 1990); In re Gosteli, 872 F.2d
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`1008 (Fed. Cir. 1989); Appeal No. 2012-007309 (Patent Tr. & App. Bd.,
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`November 29, 2012) (finding the disclosure of priority applications sufficient to
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`anticipate despite being insufficient for the purposes of according priority).
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`As shown below, claims 1-3, 6-11, 13-17, 19, 20 and 22 are anticipated by
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`the Kordunsky PCT.
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`Claim 1: The Kordunsky PCT discloses all elements of claim 1, as shown in
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`the Table below.
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` Claim
`
`1 A fluorescence detection
`apparatus for analyzing
`samples located in a
`plurality of wells in a
`thermal cycler, the apparatus
`comprising:
`
`Disclosures in the Kordunsky PCT (Ex.
`1009, emphasis added)
`“A fluorescence detection apparatus for
`analyzing samples located in a plurality of
`wells in a thermal cycler and methods of use
`are provided. In one embodiment, the
`apparatus includes a support structure
`attachable to the thermal cycler….” (Ex.
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`IPR of USPN 8,236,504
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`1009, Abstract, ¶11)
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`a a support structure
`attachable to the thermal
`cycler;
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`“In one embodiment, the apparatus includes a
`support structure attachable to the thermal
`cycler.” (Ex. 1009, Abstract)
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`b a shuttle movably mounted
`on the support structure; and
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`c a detection module attached
`to the shuttle, the detection
`module including:
`
`d a housing having an opening
`oriented toward the plurality
`of wells
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`e an excitation light generator
`disposed within the housing;
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`f an emission light detector
`disposed within the housing,
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`“Movably mounted on the underside of
`support frame 230 is a shuttle 232..." (Ex.
`1009, ¶31)
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`“Movably mounted on the underside of
`support frame 230 is a shuttle 232, which
`holds a detection module 234.” (Ex. 1009,
`¶31)
`
`“Detection module 234 may include one or
`more instances of excitation/detection pair
`600…. Excitation/detection pair 600 is
`arranged inside opaque walls 602….” (Ex.
`1009, FIGS. 2, 3, 5, and ¶39)
`"Optical communication between the
`excitation/ detection pair 600 and reaction
`vessel 616 is provided by opening 502 in
`opaque walls 602" (Ex. 1009, ¶40, see
`FIG. 6)
`“Fig. 5A is a bottom view of one embodiment
`of detection module 234, showing four
`openings 502,504,506,508… arranged inside
`the body of detection module 234.” (Ex.
`1009, FIG. 5A, ¶37)
`"… opening 502 is placed in optical
`communication with one of the sample wells
`210" (Ex. 1009, ¶¶37, 38, Fig. 6)
`
`“…the excitation/detection channel including
`an excitation light generator disposed
`within the detection module and an emission
`light detector disposed within the detection
`module.” (Ex. 1009, FIG. 6, ¶13)
`
`“…the excitation/detection channel including
`an excitation light generator disposed within
`the detection module and an emission light
`detector disposed within the detection
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`g wherein, when the support
`structure is attached to the
`thermal cycler,
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`h a heating element is
`disposed between the
`detection module and the
`sample wells and
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`IPR of USPN 8,236,504
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`module.” (Ex. 1009, FIG. 6; ¶13)
`
`"Support frame 230 and supports 224 are
`advantageously dimensioned such that when
`lid 122 is positioned in base unit 110 and
`closed, detection module 234 is held in close
`proximity to lid heater 204." (Ex. 1009, FIG.
`1; ¶31)
`“When the support structure is attached to
`the thermal cycler…” (Ex. 1009, Abstract;
`¶11)
`"Some examples of base unit 110 include the
`DNA Engine®, Dyad™, and Tetrad™
`thermal cyclers." (Ex. 1009, ¶24)
`
`“Lid heater 204 has holes 220 therethrough,
`matching the size and spacing of the sample
`wells 210, and electronically controlled
`heating elements (Ex. 1009, not shown).”
`(Ex. 1009, FIG. 2; ¶28)
`
`"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. 1009, ¶31)
`
`"Shuttle 232 is movable in two dimensions so
`as to position detection module 234 in optical
`communication … through the corresponding
`holes 220 in lid heater 204." (Ex. 1009, ¶31)
`
`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.
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`i
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`j
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`
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`13
`a
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`Claim 13 is substantially similar to claim 1, and is anticipated as follows.
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`Claim 13
`A thermal cycler apparatus
`comprising:
`a thermal cycler having an
`exterior housing and a
`plurality of sample wells
`for holding reaction
`
`Disclosures in the Kordunsky PCT (Ex.
`1009, emphasis added)
`“A fluorescence detection apparatus for
`analyzing samples located in a plurality of
`wells in a thermal cycler and methods of use
`are provided. In one embodiment, the apparatus
`includes a support structure attachable to the
`thermal cycler….” (Ex. 1009, Abstract, ¶11)
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`IPR of USPN 8,236,504
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`vessels;
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`"Lid 122 provides optical and thermal isolation
`for the components inside lid assembly 112."
`(Ex. 1009, ¶25, see also Figs. 1, 2)
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`b a heater to prevent
`condensation from
`forming on a surface of the
`reaction vessels when the
`reaction vessel