Trials@uspto.gov
`571-272-7822
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` Paper No. 8
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` Entered: April 3, 2017
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`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.
`____________
`
`Case IPR2017-00055
`Patent 8,236,504 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`Agilent Exhibit 1252
`Page 1 of 14
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`571-272-7822
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`
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`
`
`
`
` Paper No. 8
`
` Entered: April 3, 2017
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`
`
`
`
`
`
`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.
`____________
`
`Case IPR2017-00055
`Patent 8,236,504 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`Agilent Exhibit 1252
`Page 1 of 14
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`
`
`IPR2017-00055
`Patent 8,236,504 B2
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`
`INTRODUCTION
`
`Thermo Fisher Scientific Inc. (“Petitioner”) filed a Petition for an
`
`inter partes review of claims 1–3, 6–11, 13–17, and 19–22 of U.S. Patent
`
`No. 8,236,504 B2 (“the ’504 patent,” Ex. 1001). Paper 3 (“Pet.”). Bio-Rad
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`Laboratories, Inc. (“Patent Owner”) timely filed a Preliminary Response.
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`Paper 7 (“Prelim. Resp.”). We review the Petition under 35 U.S.C. § 314(a),
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`which provides that an inter partes review may not be instituted unless
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`“there is a reasonable likelihood that the petitioner would prevail with
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`respect to at least 1 of the claims challenged in the petition.”
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`Based on the arguments and evidence presented in the Petition and
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`Preliminary Response, we determine there is a reasonable likelihood
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`Petitioner would prevail with respect to claims 1–3, 6–11, 13–17, 19, 20, and
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`22 of the ’504 patent. Therefore, we institute an inter partes review of those
`
`challenged claims. Petitioner, however, has not met its burden regarding
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`claim 21. Thus, we deny the Petition with regard to claim 21.
`
`Related Proceedings
`
`According to the parties, Patent Owner has asserted the ’504 patent
`
`against Petitioner in Bio-Rad Labs, Inc. v. Thermo Fisher Scientific Inc.,
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`Case No. 16-358 (D. Del.). Pet. 57; Paper 5, 2.
`
`Petitioner concurrently filed a petition IPR2017-00054, challenging
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`the same claims of the ’504 patent based on different prior art. Pet. 57;
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`Paper 5, 2. We instituted inter partes review in that proceeding on March
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`17, 2017. IPR2017-00054, Paper 8.
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`2
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`Agilent Exhibit 1252
`Page 2 of 14
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`
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`IPR2017-00055
`Patent 8,236,504 B2
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`
`The ’504 Patent
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`The ’504 patent “relates in general to fluorescence detection systems
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`and in particular to a fluorescence detection system having a movable
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`excitation/detection module for use with a thermal cycler.” Ex. 1001, 1:21–
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`24.
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`The ’504 patent states that both thermal cyclers and fluorometers for
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`use with fluorescent-labeled samples were known in the art. Id. at 1:25–64.
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`It also acknowledges the teachings in prior art of an integrated optical reader
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`with a thermal cycler. Id. at 2:1–4. According to the ’504 patent,
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`then-“[e]xisting fluorometers suffer from various drawbacks,” and the ’504
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`patent discloses “an improved fluorometer for a thermal cycler that
`
`overcomes these disadvantages.” Id. at 2:11, 54–55.
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`Illustrative Claims
`
`Among the challenged claims, claims 1 and 13 are independent. They
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`are reproduced below (brackets added):
`
`1. A fluorescence detection apparatus for analyzing samples
`located in a plurality of wells in a thermal cycler, the apparatus
`comprising:
`
`[a] a support structure attachable to the thermal cycler;
`
`[b] a shuttle movably mounted on the support structure; and
`
`[c] a detection module attached to the shuttle, the detection
`module including:
`
`[c1] a housing having an opening oriented toward the
`plurality of wells;
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`[c2] an excitation light generator disposed within the
`housing; and
`
`3
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`Agilent Exhibit 1252
`Page 3 of 14
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`IPR2017-00055
`Patent 8,236,504 B2
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`[c3] 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.
`
`13. A thermal cycler apparatus comprising:
`
`[a] a thermal cycler having an exterior housing and a plurality
`of sample wells for holding reaction vessels;
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`[b] 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;
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`[c] a support structure disposed inside the exterior housing on
`an opposite side of the heater from the sample wells;
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`[d] a shuttle movably mounted on the support structure; and
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`[e] 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
`
`4
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`Agilent Exhibit 1252
`Page 4 of 14
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`IPR2017-00055
`Patent 8,236,504 B2
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`plurality of sample wells through the transparent portions
`of the heater.
`
`Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability:
`
`Claim(s)
`1–3, 6–11, 13–17, 19, 20, 22
`
`Basis
`§ 103(a)
`
`21
`
`§ 103(a)
`
`1–3, 6–8, 10, 13, 15, 16, 19,
`20, 22
`9, 11, 14, 17
`
`§ 103(a)
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`§ 103(a)
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`21
`
`§ 103(a)
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`References
`Pantoliano,1 Miller,2 and
`Gambini3
`Pantoliano, Miller,
`Gambini, and Li4
`Pantoliano, Iwasaki,5 and
`Gambini
`Pantoliano, Iwasaki,
`Gambini, and Miller
`Pantoliano, Iwasaki,
`Gambini, and Li
`
`In support of its patentability challenge, Petitioner relies on the
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`Declaration of Dr. Richard Mathies. Ex. 1002.
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`ANALYSIS
`
`Claim Construction
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`In an inter partes review, the Board interprets a claim term in an
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`unexpired patent according to its broadest reasonable construction in light of
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`
`
`1 Pantoliano, et al., U.S. Patent 6,303,322, issued October 16,
`2001(Ex. 1005).
`2 Miller, et al., U.S. Patent No. 5,528,050, issued June 18, 1996 (Ex. 1006).
`3 Gambini, et al., International Publication No. WO 99/60381, published
`November 25, 1999 (Ex. 1007).
`4 Certified Translation of Li, et al., Chinese Publication No. CN1379236A,
`published November 13, 2002 (Ex. 1040).
`5 Certified Translation of Iwasaki, et al., Japanese Publication No. JP2001-
`242081, published September 7, 2001 (Ex. 1009).
`5
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`Agilent Exhibit 1252
`Page 5 of 14
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`IPR2017-00055
`Patent 8,236,504 B2
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`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b);
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`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
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`that standard, and absent any special definitions, we assign claim terms their
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`ordinary and customary meaning, as would be understood by one of ordinary
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`skill in the art at the time of the invention, in the context of the entire patent
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`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007). Any special definitions for claim terms must be set forth with
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`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
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`1475, 1480 (Fed. Cir. 1994).
`
`Petitioner does not propose express construction for any claim terms.
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`Pet. 3. Patent Owner argues that “heating element” as recited in claim 1, and
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`“heater” as recited in claim 13 “correspond to the lid heater disclosed in the
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`specification of the [’]504 patent.” Prelim. Resp. 6–7. We determine that,
`
`although a “heating element”/“heater” includes a lid heater disclosed in the
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`’504 patent, it is not so limited.
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`In the ’504 patent, the lid heater “is coupled to” the lid, and the lid is
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`placed “on the sample unit.” Ex. 1001, 5:3–4, 5:8–9. Patent Owner does not
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`present persuasive evidence, and we do not find any, to show that the lid
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`heater in the ’504 patent is anywhere other than above the sample wells.
`
`Claim 13 requires a detection module be positioned “in optical
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`communication with different sample wells of the plurality of sample wells
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`through the transparent portions of the heater.” Claim 21 depends from
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`claim 13 and further recites that “the detection module is positioned such
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`that the opening is below the plurality of sample wells.” A detection module
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`placed below sample wells as required by claim 21 could not view the wells
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`6
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`Agilent Exhibit 1252
`Page 6 of 14
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`IPR2017-00055
`Patent 8,236,504 B2
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`“through” the lid heater, which is only described as placed on top of the
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`wells.
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`Thus, based on the current record, we determine that the “heating
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`element”/“heater” recited in the challenged claims includes, but is not
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`limited to, the lid heater disclosed in the ’504 patent. This determination as
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`to the scope of “heating element”/“heater” is sufficient for purposes of this
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`Decision, and we need not further address the terms at this time.
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`On this record and for purposes of this Decision, we see no need to
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`construe any other term expressly. See Wellman, Inc. v. Eastman Chem.
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`Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need
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`only be construed to the extent necessary to resolve the controversy).
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`Obvious over Pantoliano, Miller, and Gambini
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`Petitioner argues that claims 1–3, 6–11, 13–17, 19, 20, and 22 would
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`have been obvious over the combination of Pantoliano, Miller, and Gambini.
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`Pet. 15–23. Based on the current record, we determine Petitioner has
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`established a reasonable likelihood that it would prevail in this assertion.
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`Pantoliano teaches an apparatus that can be used to perform thermal
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`cycling steps for any purpose, including a polymerase chain reaction (PCR).
`
`Ex. 1005, 42:57–59. For challenged claim 1, Petitioner argues that
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`Pantoliano teaches all but two limitations. Pet. 18. For example, Petitioner
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`contends that Pantoliano combines a thermal cycling block for “heating a
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`plurality of samples” with a real-time fluorescent sensor “for receiving
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`spectral emission from the samples while the samples are being heated.” Id.
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`at 6 (citing Ex. 1005, 9:9–21, 9:47–58). Petitioner also refers to Pantoliano
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`7
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`Agilent Exhibit 1252
`Page 7 of 14
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`for teaching “a plurality of wells . . . for a plurality of samples,” as the
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`preamble requires. Id. at 7 (citing Ex. 1005, 33:37–40, Figs. 29–35).
`
`For limitation [a], Petitioner asserts that Pantoliano teaches a support
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`structure in the form of a variety of interconnected structures, such as a
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`“relative movement means 3130,” a “servo controller 3118,” and a “filter
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`housing 3160,” all of which are attached to the “base 3100” of the cycler.
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`Id. at 8 (citing Ex. 1005, 35:7–36:2, Figs. 31–35). For limitation [b],
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`Petitioner argues that Pantoliano teaches “a shuttle in the form of a ‘sensor
`
`armature 3120[,]’ which is movably mounted on the various support
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`structures.” Id. at 8–9 (citing Ex. 1005, 35:7–36:2, Figs. 31–35).
`
`Petitioner contends that Pantoliano teaches a detection module in the
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`form of a sensor, such as a fiber-optic probe or a CCD camera, attached to
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`the movable sensor armature (i.e., shuttle), as limitation [c] requires. Id. at 9
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`(citing Ex. 1005, 33:1–8, 35:19–35, 40:39–41, Figs. 31–38). According to
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`Petitioner, each of the fiber-optic embodiment and the CCD-camera
`
`embodiment in Pantoliano has a housing, as limitation [c1] requires.
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`Patent Owner does not dispute that Pantoliano teaches or suggests
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`each of the above-discussed limitations. After reviewing the record, we are
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`satisfied that Petitioner has made a sufficient showing regarding these
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`limitations.
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`For limitations [c2] and [c3], Petitioner argues that Pantoliano teaches
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`“a generator that is a ‘light source 2906[,] which excites samples 2910 with
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`excitatory light’ such as a laser,” and “a detector in the form of a ‘spectral
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`receiving means or sensor’ for ‘receiving spectral emission from the
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`samples,’ such as a CCD or photomultiplier tube.” Pet. 11(citing Ex. 1005,
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`8
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`Agilent Exhibit 1252
`Page 8 of 14
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`IPR2017-00055
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`33:49–65, 34:16–23). Petitioner acknowledges that Pantoliano does not
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`teach the “in-head placement of the generator and detector.” Id. at 18. But,
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`according to Petitioner, this is “a known configuration for optics head [i.e.,
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`detection module]” as taught by Miller. Id. (citing Ex. 1002 ¶ 48).
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`Miller teaches a movable compact scan head having multiple scanning
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`modalities so that the scan head supports two or more optical systems within
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`a small space. Ex. 1006, 1:53–56. Petitioner argues that the dual-headed
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`detection module in Miller has two optics heads, each of which has a
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`generator and a detector within its housing, as limitations [c2] and [c3]
`
`require. Pet. 11–12 (citing Ex. 1006, 1:53–67, 2:30–33, 4:16–18, 5:35–38,
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`Figs. 1–4, 7).
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`For the wherein clause, Petitioner asserts that Pantoliano teaches the
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`support-structure- and the shuttle- related requirements. Id. at 14–15 (citing
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`Ex. 1005, 33:1–8, 35:19–35, 21:2–26, 40:39–41, Fig. 29–35). Petitioner
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`concedes that Pantoliano does not teach the “heating element” and the
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`position of the detection module relative to the heating element and wells.
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`Id. at 18. “[A] heater with optical holes,” however, Petitioner contends, is “a
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`standard component of real-time thermocyclers,” and is taught by Gambini.
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`Id. (citing Ex. 1002 ¶ 48).
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`Gambini teaches “[a]n optical instrument [that] monitors PCR
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`replication of DNA in a reaction apparatus having a temperature cycled
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`block with vials of reaction ingredients including dye that fluoresces in
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`presence of double-stranded DNA.” Ex. 1007, Abstract. According to
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`Gambini, caps for the vials, which if used, are “transparent to light utilized
`
`in the instrument,” “may rest or attach over the vials to prevent
`
`9
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`Agilent Exhibit 1252
`Page 9 of 14
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`IPR2017-00055
`Patent 8,236,504 B2
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`contamination and evaporation loss.” Id. at 6:24–28. In addition, Gambini
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`teaches a platen that “rests over the vial caps or, if none, directly over the
`
`vials.” Id. at 6:31–7:1. Gambini explains:
`
`The platen . . . has an array of holes . . . therethrough aligned with
`the vials, each hole having a diameter about the same as the vial
`top diameter. If there are caps, the platen should have its
`temperature maintained by a film heater or other means for
`heating the platen sufficiently to prevent condensation under the
`caps without interfering with DNA replication in the vials . . . .
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`Id. at 7:1–6.
`
`Referring to these teachings, Petitioner argues that the platen in
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`Gambini is similar to the lid heater in the ’504 patent. Pet. 13. According to
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`Petitioner, “[i]ncorporating Gambini’s lid heater and Miller’s optics head
`
`into Pantoliano’s cycler results in the lid heater being ‘disposed between’ the
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`sample wells and optics head [i.e., the detection module], as would have
`
`been apparent to artisans,” and as the wherein clause requires. Id. at 13–14
`
`(citing Ex. 1002 ¶ 45).
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`Petitioner contends that “[t]he claimed devices are merely a
`
`combination of known elements with predictable results.” Pet. 21.
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`According to Petitioner, there is a reason to combine the teachings of
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`Pantoliano, Miller, and Gambini, both from the references themselves (id. at
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`18–20) and because of the design incentives and other market forces (id. at
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`22–24). Based on the current record, we find Petitioner’s argument
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`persuasive. For example, Miller explains that “[b]y incorporating the
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`various [optical] elements into a compact scan head and moving the scan
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`head, as opposed to moving a scanning mechanism within the optical
`
`10
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`Agilent Exhibit 1252
`Page 10 of 14
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`system, a light-weight, high speed, and extremely versatile scanning system
`
`is achieved.” Ex. 1006, 2:65–3:2. And Gambini teaches the heated platen to
`
`address the issue of sample condensation. Ex. 1007, 7:3–7.
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`Patent Owner counters that, even though Pantoliano had the benefit of
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`Miller’s teaching of an optics head and Gambini’s teaching of a heated lid as
`
`of its 1997 filing date, Pantoliano did not incorporate either feature. Prelim.
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`15–17. According to Patent Owner, this suggests there was no motivation to
`
`combine the teachings of the prior art. Id. We disagree. An obviousness
`
`determination is an objective inquiry, and is analyzed from an ordinary
`
`artisan’s point of view based on the record as a whole rather than what a
`
`single prior art reference teaches. KSR Intern. Co. v. Teleflex Inc., 550 U.S.
`
`398, 406, 417–18 (2007). Thus, what the inventors of Pantoliano did or did
`
`not actually do is not dispositive in this case. We have reviewed other
`
`arguments presented by Patent Owner and are not persuaded, either.
`
`In sum, based on the current record, we conclude that Petitioner has
`
`established a reasonable likelihood that it would prevail in showing that
`
`claims 1 would have been obvious over the combination of Pantoliano,
`
`Miller, and Gambini. After considering Petitioner’s arguments and evidence
`
`with respect to claims 2, 3, 6–11, 13–17, 19, 20, and 22 (Pet. 25–38), which
`
`Patent Owner does not address separately, we determine that Petitioner has
`
`made a sufficient showing as to those claims, as well.
`
`Obvious over Pantoliano, Miller, Gambini, and Li
`
`Petitioner argues that claim 21 would have been obvious over
`
`Pantoliano, Miller, Gambini, and Li. Pet. 38–39. Based on the current
`
`11
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`Agilent Exhibit 1252
`Page 11 of 14
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`record, we determine Petitioner has not established a reasonable likelihood
`
`that it would prevail in this assertion.
`
`Li teaches a “fluorescence quantitative PCR analyzing system” with
`
`“a thermal cycling unit, a fluorescence detection unit, and a control circuit.”
`
`Ex. 1040, Abstract, claim 1. We agree with Petitioner that Figure 3 in Li
`
`shows the detection unit and its opening positioned “below the plurality of
`
`sample wells,” as claim 21 requires. See Pet. 38–39 (citing Ex. 1040, 8:16–
`
`20, 8:28–9:1, Fig. 3). Nevertheless, we determine that Petitioner has not
`
`shown a reasonable likelihood that an ordinary artisan would have arrived at
`
`the claimed device when combining the teachings of Li with those of
`
`Pantoliano, Miller, and Gambini.
`
`Claim 21 depends from claim 13, which requires the detection module
`
`be “in optical communication with different sample wells of the plurality of
`
`sample wells through the transparent portions of the heater.” Petitioner
`
`asserts that “Gambini’s heated lid required direct contact with the sample
`
`tube tops in order to heat them effectively and prevent condensation, and
`
`included optical holes to allow light through when the heated lid was placed
`
`between the wells and the optics head.” Pet. 30–31. Petitioner does not
`
`sufficiently explain how an ordinary artisan would have modified the heated
`
`lid in Gambini to adapt to a detection module located below the wells. As a
`
`result, we deny the Petition on this ground.
`
`Obviousness Challenges Based on Iwasaki and Other References
`
`Petitioner contends that (1) claims 1–3, 6–8, 10, 13, 15, 16, 19, 20,
`
`and 22 would have been obvious over Pantoliano, Iwasaki, and Gambini
`
`(Pet. 39–55); and (2) claims 9, 11, 14, and 17 would have been obvious over
`
`12
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`Agilent Exhibit 1252
`Page 12 of 14
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`IPR2017-00055
`Patent 8,236,504 B2
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`Pantoliano, Iwasaki, Gambini, and Miller (id. at 56). In view of our
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`institution of an inter partes review of all challenged claims on another
`
`ground, as set forth above, we deny institution on these additional grounds.
`
`See 37 C.F.R. § 42.108(a)–(b).
`
`Petitioner further argues that claim 21 would have been obvious over
`
`Pantoliano, Iwasaki, Gambini, and Li. Pet. 56. Petitioner relies on the same
`
`argument advanced in the ground based on Pantoliano, Miller, Gambini, and
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`Li. Id. For the same reason as explained above (supra at 12), we deny the
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`Petition on this ground.
`
`CONCLUSION
`
`For the foregoing reasons, we find that Petitioner has offered
`
`sufficient evidence to institute an inter partes review. The information
`
`presented in the Petition and accompanying evidence establishes a
`
`reasonable likelihood that Petitioner would prevail in showing the
`
`unpatentability of claims 1–3, 6–11, 13–17, 19, 20, and 22 of the ’504
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`patent.
`
`At this stage of the proceeding, the Board has not made a final
`
`determination as to the construction of any claim term or the patentability of
`
`any challenged claim.
`
`Accordingly, it is
`
`ORDER
`
`ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is
`
`hereby instituted to determine whether claims 1–3, 6–11, 13–17, 19, 20, and
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`22 would have been obvious over Pantoliano, Miller, and Gambini;
`
`13
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`Agilent Exhibit 1252
`Page 13 of 14
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`IPR2017-00055
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`FURTHER ORDERED that no other ground of unpatentability is
`
`authorized in this inter partes review; and
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`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`
`partes review of the ’504 patent is hereby instituted commencing on the
`
`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`
`§ 42.4, notice is hereby given of the institution of a trial.
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`
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`
`
`PETITIONER:
`
`Ashita Doshi
`ashita.doshi@thermofisher.com
`
`Phil Makrogiannis
`lifetechdocket@system.foundationip.com
`
`
`PATENT OWNER:
`
`Kelsey Nix
`knix@jonesday.com
`
`Colin Forestal
`caforestal@jonesday.com
`
`Lisamarie LoGiudice
`llogiudice@jonesday.com
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`14
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`Agilent Exhibit 1252
`Page 14 of 14
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