Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 15
`Entered: October 11, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`ENVIROLOGIX INC.,
`Petitioner,
`v.
`IONIAN TECHNOLOGIES, INC.,
`Patent Owner.
`_______________
`
`IPR2018-00405
`Patent 9,562,263 B2
`_______________
`
`
`Before ULRIKE W. JENKS, CHRISTOPHER G. PAULRAJ, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Requests for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`

`

`IPR2018-00405
`Patent 9,562,263 B2
`
`
`INTRODUCTION
`I.
`EnviroLogix Inc., (hereafter “Petitioner”) filed a Request for Rehearing of
`our Decision Denying Institution of inter partes review. Paper 14 (“Req. Reh’g”).
`To summarize, Petitioner filed a petition seeking inter partes review of U.S. Patent
`No. 9,562,263 B2 (Ex. 1001, “the ’263 patent”). Paper 1 (“Pet.”). We denied
`institution based upon our consideration of the challenges presented, including the
`anticipation ground relying upon Ehses1. See Paper 12 (”Decision”).
`In its Request for Rehearing, Petitioner contends that the Decision Denying
`Institution should be withdrawn, and inter partes review should be instituted
`because we misapprehended the teachings and disclosures of Ehses. Req.
`Reh’g 15. Specifically, Petitioner contends that the board misapprehended Ehses’s
`teachings relevant to the claim terms (a) “omitting a thermal denaturation” step,
`and (b) “detecting the amplified product within 10 minutes.” Id. at 1.
`Having considered the arguments set forth in Petitioner’s Request for
`Rehearing, we decline to institute inter partes review.
`II. DISCUSSION
`A party requesting rehearing has the burden to show a decision should be
`modified by specifically identifying all matters the party believes were
`misapprehended or overlooked, and the place where each matter was addressed
`previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When
`rehearing a decision on institution, we review the decision for an abuse of
`discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is
`
`
`1 Ehses et al., Optimization and design of oligonucleotide setup for strand
`displacement amplification, 63 J. BIOCHEM. BIOPHYS. METHODS 170–186 (2005)
`(Ex. 1002).
`
` 2
`
`
`
`
`
`

`

`IPR2018-00405
`Patent 9,562,263 B2
`
`based on an erroneous interpretation of law, if a factual finding is not supported by
`substantial evidence, or if the decision represents an unreasonable judgment in
`weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277,
`1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir.
`2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).
`In its Request for Rehearing, Petitioner challenges our finding that “although
`Ehses might disclose a methodology that omits the initial thermal denaturation
`step, Petitioner has not shown that this method results in a detectable product.”
`See Decision 11. Petitioner contends that “[t]he only claim requirement that is not
`expressly disclosed in Ehses is that product is detected by monitoring fluorescence
`intensity in real-time during the first ten minutes of the reaction,” but the limitation
`is inherently disclosed “because Ehses monitors the formation of amplified product
`in real time, [and] the product is necessarily detected as it accumulates.” Req.
`Reh’g 3, 8. With respect to such monitoring, Petitioner argues that “Ehses
`discloses the same type of real-time detection using an ICycler and ‘an
`intercalating fluorescence dye TOPRO-1’” as the real-time detection described by
`the examples of the ’263 patent. Id. at 8 (citing Ex. 1002, 178; citing Petition at 12
`(citing Ex. 1001, 27:1–47)(emphasis removed).
`We remain unpersuaded by this argument. As discussed in our Decision,
`anticipation by inherency requires that any missing material must be recognized by
`the POSITA as necessarily present. Decision 19 (citing In re Robertson, 169 F.3d
`743 (Fed. Cir. 1999)). In the Petition, Petitioner contends that Ehses discloses
`amplification of a target in real time based on Ehses’s teaching that “the increase in
`fluorescence intensity was monitored” and Dr. Edwards’ opinion that “[d]yes that
`bind DNA, like TO-PRO-1, generate a fluorescent signal upon binding that is
`detected in” real time. Pet. 21 (citing Ehses 175; Ex. 1008 (Edwards Decl.) ¶ 82).
`
` 3
`
`
`
`
`
`

`

`IPR2018-00405
`Patent 9,562,263 B2
`
`In order to meet the claim requirements, however, Petitioner must first show
`that Ehses performed real-time detection in an assay that also omits the initial
`denaturation step. See Decision 11; see Prelim. Resp. 11 (“the petition provides no
`comparison of the reaction conditions disclosed in Ehses to the reaction conditions
`recited in the claims”). But Ehses does not teach omitting the denaturation step as
`part of its Standard and Nicking protocols. See Ehses 175 (2.1.2 Standard SDA
`and 2.1.3 Nicking SDA). Rather, in a single sentence, Ehses mentions the
`omission of a denaturation step only in comparison to the experimental protocols
`in which a denaturation step is expressly included, but even then cautions that such
`an omission tends to result in undesirable side reactions. Ehses 177. Thus,
`contrary to Petitioner’s arguments, we do not find that Ehses teaches real-time
`detection of target DNA within 10 minutes was necessarily performed using the
`TO-PRO-1 dye when “omitting the initial denaturation step.” Id.
`We further note that Ehses’s Standard SDA protocol uses “either 1 µM TO-
`PRO-1 or 1:5 SYBR Gold” as the visualization dye. Ehses 175. But there is no
`evidence on this record that TO-PRO-1 and SYBR Gold can be used
`interchangeably in a real-time detection assay. The ’263 patent, for example, does
`not use SYBR Gold or TO-PRO-1 in any of its real-time detection assays, but
`instead uses a different fluorescence dye—SYBR II—for monitoring product
`accumulation in real-time. See Ex. 1001, 8:64–9:9 see 27:8–9 (“The fluorescence
`increases as SYBR II intercalates into the amplified double-stranded products”).
`And despite Dr. Edwards’ reference to “[d]yes that bind DNA, like TO-PRO-1”
`(Ex. 1008 ¶ 82), Petitioner has not argued or otherwise presented evidence
`showing that SYBR Gold would necessarily detect double stranded target product
`within 10 minutes—particularly in light of Ehses’s teaching that omission of the
`
` 4
`
`
`
`
`
`

`

`IPR2018-00405
`Patent 9,562,263 B2
`
`initial denaturation step tends to result in side reactions. See Ehses 177.2
`Accordingly, we are further unpersuaded by Petitioner’s argument because
`Petitioner has not established that Ehses performed real-time detection under the
`claimed conditions using TO-PRO-1, or that the alternative, SYBR Gold, would
`necessarily detect double stranded product within 10 minutes when the nicking
`assay was run in the absence of a denaturation step.
`Petitioner further contends that we misapprehended the kinetic profile of
`Ehses’s real-time detection reaction. Req. Reh’g 10–11. We did not. We
`recognized in our Decision that Ehses teaches a “two step kinetic profile,” wherein
`“using an intercalating fluorescence dye TOPRO-1 in real-time detection, after
`about 20 min the fluorescence intensity signal shows a steep increase.” Decision,
`12 (citing Ehses, 178). Based on that teaching, we concluded that “the Ehses
`reference itself indicates that using real-time detection based on fluorescence
`intensity will take longer than 10 minutes.” Id. As noted above, Ehses does not
`teach that real time detection is necessarily performed when omitting the
`denaturation step. But even assuming that Ehses could be interpreted in a contrary
`manner, Petitioner did not present any evidence with its Petition showing either
`that the real time detection in Ehses would necessarily begin immediately (i.e., at
`or near “time zero”) or that the target product would necessarily be detected within
`10 minutes when the denaturation step is omitted.
`In its Request for Rehearing, Petitioner relies upon Figure 3.4 of Ehses
`Dissertation as teaching that real-time detection with TO-PRO-1 begins near time
`
`
`2 Although not established as prior art, the Ehses Dissertation indicates that TO-
`PRO-1 fluoresces in the presence of double stranded DNA, whereas SYBR Gold
`detects both double and single-stranded products. See Ex. 1004, 37.
`
` 5
`
`
`
`
`
`

`

`IPR2018-00405
`Patent 9,562,263 B2
`
`zero when fluorescence begins to increase and continues during the reaction. Req.
`Reh’g 12. Petitioner has not challenged our determination that Ehses Dissertation
`fails to qualify as prior art, nor otherwise explained why the Ehses Dissertation
`reflects the understanding of those of ordinary skill at the relevant time. See
`Decision 15 (“Petitioner has [not] made a threshold showing that the Ehses
`Dissertation was sufficiently publicly accessible to qualify as a ‘printed
`publication’ under § 102(b)”). Moreover, Petitioners did not previously rely upon
`any teachings of Ehses Dissertation, particularly Figure 3.4, to support an
`inherency argument for Ehses anticipation grounds in the Petition. A request for
`rehearing is not an opportunity for the requestor to present new arguments or
`evidence. Accordingly, we are not persuaded by Petitioner’s assertion that we
`overlooked or misapprehended Petitioner’s anticipation arguments in light of the
`newly cited disclosure of the Ehses Dissertation.
`Additionally, Petitioner contends that any disputed issue of material fact
`must be resolved in Petitioner’s favor, citing 37 C.F.R. § 42.108. Req. Reh’g 14–
`15.
`
`37 C.F.R. § 42.108(c) reads in relevant part:
`The Board’s decision will take into account a patent owner preliminary
`response where such a response is filed, including any testimonial
`evidence, but a genuine issue of material fact created by such
`testimonial evidence [filed by Patent Owner] will be viewed in the light
`most favorable to the petitioner solely for purposes of deciding whether
`to institute an inter partes review.
`Thus, it is only genuine issues of material fact created by testimonial
`evidence provided by the patent owner with its preliminary response that we must
`view “in the light most favorable to petitioner.” 37 C.F.R. § 42.108(c). Because
`Patent Owner did not provide testimonial evidence in this proceeding, there is no
`
` 6
`
`
`
`
`
`

`

`IPR2018-00405
`Patent 9,562,263 B2
`
`“genuine issue of material fact created by such testimonial evidence.” Rather, the
`panel has drawn its own inferences and conclusions from the arguments and
`evidence of record. See Rovalma, S.A. v. Bohler-Edelstahl GmbH & Co. KG, 856
`F.3d 1019, 1027 (Fed. Cir. 2017) (noting that the Board is not precluded “from
`relying on arguments made by a party and doing its job, as adjudicator, of drawing
`its own inferences and conclusions from those arguments”). Our plain reading of
`Ehses persuades us that Petitioner has not demonstrated a reasonable likelihood of
`prevailing as to any challenged claim.
`Accordingly, Petitioner has not established that we abused our discretion on
`this basis.
`
`
`III. CONCLUSION
`For the foregoing reasons, Petitioner has not demonstrated that we abused
`our discretion, or that we misapprehended or overlooked any issue, in exercising
`our discretion to deny institution.
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s Requests for Rehearing is denied.
`
`
`
`
` 7
`
`
`
`
`
`

`

`IPR2018-00405
`Patent 9,562,263 B2
`
`PETITIONER:
`Jonathan D. Ball, Ph.D.
`Melissa Hunter-Ensor, Ph.D.
`GREENBERG TRAURIG, LLP
`ballj@gtlaw.com
`hunterensorm@gtlaw.com
`bosipmail@gtlaw.com
`
`PATENT OWNER:
`Aaron F. Barkoff, Ph.D.
`Christopher P. Singer, Ph.D.
`MCANDREWS, HELD & MALLOY, LTD.
`abarkoff@mcandrews-ip.com
`csinger@mcandrews-ip.com
`
` 8
`
`
`
`
`
`