Trials@uspto.gov
`571-272-7822
`
`
`Paper No. 36
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` Entered: July 11, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INSTRUMENTATION LABORATORY COMPANY,
`Petitioner,
`
`v.
`
`HEMOSONICS LLC,
`Patent Owner.
`____________
`
`Case IPR2017-00852
`Patent 9,272,280 B2
`____________
`
`
`
`Before JO-ANNE M. KOKOSKI, KRISTINA M. KALAN, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges
`
`
`ABRAHAM, Administrative Patent Judge
`
`
`
`
`
`DECISION
`Granting Patent Owner’s Motion to Submit Supplemental Information
`Pursuant to 37 C.F.R. § 42.123(b)
`
`
`
`
`
`
`
`

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`Case IPR2017-00852
`Patent 9,272,280 B2
`
`
`I.
`
`INTRODUCTION
`
`On September 1, 2017, we instituted trial with respect to the question
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`of whether Baugh1 anticipates claims 1 and 2 of U.S. Patent No. 9,272,280
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`B2 (“the ’280 patent,” Ex. 1001). Paper 14 (“Inst. Dec.”), 12. On April 26,
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`2018, we modified our institution decision to include review of “all
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`challenged claims and all of the grounds presented in the Petition,” including
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`the question of whether claims 1 and 2 are anticipated by Schubert.2 Paper
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`26, 2.
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`On May 15, 2018, we authorized Instrumentation Laboratory
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`Company (“Petitioner”) to file a motion to submit supplemental information
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`pursuant to 37 C.F.R. § 42.123(b),3 and also authorized Hemosonics LLC
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`(“Patent Owner”) to file an opposition to the motion. Subsequently,
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`Petitioner filed its Motion to Submit Supplemental Information Pursuant to
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`1 Baugh et al., U.S. Patent No. 6,221,672 B1, issued Apr. 24, 2001
`(“Baugh,” Ex. 1005).
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`2 Schubert et al., U.S. Pub. No. 2010/0154520 A1, published June 24, 2010
`(“Schubert,” Ex. 1006).
`
`3 Patent Owner argues that the supplemental materials are “submitted within
`one month of the institution of the grounds to which they relate under 37
`C.F.R. § 42.123(a).” Mot. 4–5, n.i. We disagree, and maintain the position
`stated in our May 14, 2018, email to the parties, wherein we authorized
`briefing under 37 C.F.R. § 42.123(b), and notified the parties that
`§ 42.123(a) does not apply in this proceeding because the trial for this inter
`partes review was instituted on September 1, 2017. Section 42.123(a) refers
`to the date the trial is instituted, not the date a ground is instituted. See 37
`C.F.R. § 42.123(a) (“Once a trial has been instituted, a party may file a
`motion to submit supplemental information in accordance with the following
`requirements: (1) A request for the authorization to file a motion to submit
`supplemental information is made within one month of the date the trial is
`instituted.”) (emphasis added).
`
`
`
`2
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`Case IPR2017-00852
`Patent 9,272,280 B2
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`37 C.F.R. § 42.123 (“Mot.,” Paper 28), and Patent Owner filed an
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`Opposition (“Opp.,” Paper 29).
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`II.
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` BACKGROUND
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`Independent claim 1 of the ’280 patent recites a device having first
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`and second chambers that include an “activator of coagulation.” Ex. 1001,
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`19:4–19. In the Petition, Petitioner argued Schubert discloses the use of
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`coagulation activators, and directed us to paragraph 83 of Schubert, which
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`refers to “tests for intrinsic and extrinsic activation of a blood sample
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`(INTEMTM or EXTEMTM respectively).” Paper 2 (“Pet.”), 21–23 (citing
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`Ex. 1006 ¶ 83).
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`In its Preliminary Response, Patent Owner asserted that Petitioner
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`failed to demonstrate how Schubert discloses using an activator of
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`coagulation. Paper 6 (“Prelim. Resp.”), 20–24. Specifically, Patent Owner
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`argued that
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`[Schubert] mentions the EXTEM and INTEM tests as tests for
`intrinsic and extrinsic activation of a blood sample. Ex. 1006 ¶
`[0083]. However, [Schubert] does not explicitly state that these
`tests include, as a reagent, an activator of coagulation. In
`particular, although the leading sentence of Paragraph 83
`mentions reagents, the only reagent explicitly disclosed in that
`paragraph is cytochalasin D, . . . which is not an activator of
`coagulation. Id.
`
`Id. at 21. Patent Owner also argued that Petitioner cannot rely on what
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`would have been “apparent to a person of ordinary skill in the art” regarding
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`the aforementioned tests to “close the gap” in Schubert and satisfy its burden
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`of proving Schubert discloses an activator of coagulation. Id.
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`III.
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` THE SUPPLEMENTAL INFORMATION
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`Petitioner seeks to submit information from IPR2018-00950 (“the 950
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`IPR”), which Patent Owner filed on April 20, 2018. In the 950 IPR, Patent
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`3
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`Case IPR2017-00852
`Patent 9,272,280 B2
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`Owner challenges the patentability of U.S. Patent No. 9,915,671 (“the ’671
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`patent”), which is a continuation of Schubert.4 According to Petitioner, the
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`information it seeks to enter involves “admissions relating to” the ’671
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`patent, “and characterizations of technical terms and prior art relating to
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`[Schubert] by both Patent Owner and Patent Owner’s expert Dr. Diamond.”
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`Mot. 2. The information Petitioner seeks to submit includes (1) portions of
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`Patent Owner’s petition from the 950 IPR, (2) portions of the Declaration
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`filed by Dr. Diamond in the 950 IPR (the “Diamond Declaration”), (3) a
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`copy of the ’671 patent, and (4) a copy of an article referred to as Lang
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`2006.5 Id. at 1. Petitioner submitted copies of these documents with its
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`Motion as Exhibits 1065–1068, respectively.
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`IV. ANALYSIS
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`Pursuant to 37 C.F.R. § 42.123(b), a motion to submit supplemental
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`information filed more than one month after the trial date is instituted must
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`show why the supplemental information reasonably could not have been
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`obtained earlier, and that consideration of the supplemental information
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`would be in the interests of justice.
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`Petitioner contends that the admissions and characterizations from the
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`950 IPR it seeks to submit in this proceeding are relevant to the challenges
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`in the present proceeding based on Schubert, and directly contradict
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`positions taken by Patent Owner in this proceeding. Mot. 2. Petitioner
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`contends the information could not have been entered earlier, as Patent
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`4 Petitioner contends, and Patent Owner does not dispute, that the disclosure
`of the ’671 patent and Schubert are identical. Mot. 3.
`5 Lang T. and von Depka M., Possibilities and Limitations of
`Thromboelastometry/-graph, Hämostaseologie, 2006; 26 (Suppl. 1): S20–
`S29.
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`
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`4
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`Case IPR2017-00852
`Patent 9,272,280 B2
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`Owner only recently filed the petition in the 950 IPR, and the information
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`only became relevant after we modified our Institution Decision to include
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`challenges based on Schubert. Id. Petitioner asserts that consideration of
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`the supplemental information would be in the interests of justice because
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`“[i]t would be prejudicial to Petitioner not to hold Patent Owner to its own
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`assertions, especially where such assertions (1) involve the same disclosure
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`relied on as a primary reference for invalidity grounds in the present
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`proceeding and (2) resolve a critical issue of material fact.” Id.
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`Patent Owner argues that Petitioner misrepresents the arguments
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`Patent Owner made in its Preliminary Response in an attempt to
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`“manufacture a purported inconsistency.” Opp. 2. Patent Owner argues that
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`it responded to Petitioner’s arguments that Schubert anticipated certain
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`claims of the ’280 patent by arguing that Schubert does not explicitly state
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`that EXTEM and INTEM tests include, as a reagent, an activator of
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`coagulation. Id. (citing Prelim. Resp. 21). Patent Owner also argued that
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`Petitioner failed to provide evidence supporting its assertion concerning the
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`meaning of terms that appear in Schubert. Id. Thus, rather than making
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`arguments about the meaning of EXTEM and INTEM, Patent Owner sought
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`to “hold [Petitioner] to its obligation of establishing through evidence the
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`disclosure of the prior art.” Id. at 2–3. According to Patent Owner, the
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`arguments made in the Preliminary Response are not inconsistent with those
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`presented in the 950 IPR.
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`Patent Owner also argues that Petitioner does not explain why it could
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`not have submitted Lang 2006 when it filed its Petition, and that Petitioner is
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`seeking to “remedy fatal defects in its petition.” Id. at 1–2. Additionally,
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`Patent Owner argues Petitioner fails to justify the need for submitting 54
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`Case IPR2017-00852
`Patent 9,272,280 B2
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`pages from the petition in the 950 IPR and 144 pages from the Diamond
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`Declaration. Id. at 5. Patent Owner contends that any supplementation
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`should be limited to paragraphs 88, 91, and 93 of the Diamond Declaration.
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`Id.
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`The supplemental information at issue relates to the question of
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`whether Schubert discloses a reagent that is an activator of coagulation, as
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`recited in claim 1 of the ’280 patent. Petitioner cites to paragraph 83 of
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`Schubert in support of its argument in the present proceeding that Schubert
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`discloses, inter alia, a chamber with a coagulation activator. Pet. 21–23.
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`According to Petitioner, in the petition filed in the 950 IPR, Patent Owner
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`cites to the paragraph in the ’671 patent that corresponds to paragraph 83 of
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`Schubert, and “states that the ‘671 patent disclosure . . . teaches
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`‘incorporating several reagent compositions into the cartridge’ and that
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`‘these reagents include compounds that activate blood coagulation through
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`the intrinsic pathway (INTEM) and extrinsic pathway (EXTEM), and
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`compounds that suppress thrombocyte (a.k.a. platelet) function (FIBTEM).’”
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`Mot. 3–4 (citing page 9 of the 950 IPR petition). In his Declaration, Dr.
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`Diamond similarly discusses the paragraph in the ’671 patent that
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`corresponds to paragraph 83 of Schubert. Id.
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`Thus, the supplemental information from the 950 IPR addresses the
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`same disclosure relied on as a primary reference for invalidity grounds in the
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`present proceeding and relates to a critical issue in this proceeding, namely,
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`whether Schubert discloses first and second chambers that include an
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`activator of coagulation. See Inst. Dec. 11 (determining, based on the record
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`at that time, that Petitioner had “failed to demonstrate adequately that
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`Schubert discloses each and every limitation of independent claim 1”). In
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`Case IPR2017-00852
`Patent 9,272,280 B2
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`view of this, we determine that considering such information would be in the
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`interests of justice.
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`We are not persuaded by Patent Owner’s argument that no
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`inconsistency exists between the arguments made in its Preliminary
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`Response in this proceeding and the arguments presented in the 950 IPR.
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`Opp. 1–3. Patent Owner focuses on the fact that it argued in the Preliminary
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`Response that Schubert “does not explicitly state” that the tests include an
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`activator of coagulation, and contends that it did not directly contradict that
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`statement in the 950 IPR. Although Petitioner does not direct us to any
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`evidence showing Patent Owner argued the ’671 patent “explicitly states”
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`that the EXTEM and INTEM tests include an activator of coagulation as a
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`reagent, which would constitute the direct opposite of Patent Owner’s
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`argument in the Preliminary Response, Patent Owner’s arguments in the 950
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`IPR petition that the ’671 patent itself discloses coagulation activators, are
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`inconsistent with its argument in the Preliminary Response that there is a
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`“gap” in Schubert regarding the disclosure of coagulation activators. See,
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`e.g., Prelim. Resp. 21.
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`We next address the question of whether Petitioner could have
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`obtained the supplemental information earlier. See 37 C.F.R. § 42.123(b).
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`With respect to the arguments made in the 950 IPR petition and the
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`statements in the Diamond Declaration submitted with that petition, it is
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`undisputed that Petitioner could not have obtained these materials earlier
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`than April 20, 2018, which is the date Patent Owner filed the petition in the
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`950 IPR.
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`In view of the foregoing, we determine that Petitioner has shown
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`sufficiently why certain statements in the petition filed in the 950 IPR and
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`Case IPR2017-00852
`Patent 9,272,280 B2
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`the Diamond Declaration submitted with that petition reasonably could not
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`have been obtained earlier, and that consideration of the supplemental
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`information would be in the interests-of-justice. We agree with Patent
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`Owner, however, that Petitioner has not justified the need for submitting 54
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`pages from the petition and 144 pages from the Diamond Declaration.
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`Therefore, Exhibits 1065 and 1066 filed with Petitioner’s Motion will be
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`expunged. Petitioner may re-submit the cover page, and pages 7–9 of the
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`petition in the 950 IPR as Exhibit 1065, and the cover page, signature page,
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`and pages containing paragraphs 88, 91, and 93 of the Diamond Declaration,
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`as Exhibit 1066. The ’671 patent will remain as Exhibit 1067 to provide
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`context for the statements made in the petition and Diamond Declaration
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`filed in the 950 IPR.
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`We agree with Patent Owner that Petitioner failed to explain why it
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`could not have submitted Lang 2006, which was published in 2006, earlier,
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`and therefore has not met its burden under 37 C.F.R. § 42.123(b). Opp. 4.
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`As a result, Exhibit 1068 will be expunged.
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`No additional arguments or filings with regard to the supplemental
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`information are permitted at this time.
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`
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`Accordingly, it is hereby:
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`ORDER
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`ORDERED that Petitioner’s Motion to File Supplemental Information
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`is granted-in-part;
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`FURTHER ORDERED that Exhibits 1065, 1066, and 1068 are
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`expunged;
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`Case IPR2017-00852
`Patent 9,272,280 B2
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`FURTHER ORDERED that Petitioner is authorized to submit, as
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`Exhibit 1065, the cover page, and pages 7–9 of the petition filed in IPR2018-
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`00950;
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`FURTHER ORDERED that Petitioner is authorized to submit, as
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`Exhibit 1066, the cover page, signature page, and pages containing
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`paragraphs 88, 91, and 93 of the Declaration filed by Dr. Diamond in
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`IPR2018-00950; and
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`FURTHER ORDERED that no additional arguments or filings with
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`regard to supplemental information are permitted at this time.
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`Case IPR2017-00852
`Patent 9,272,280 B2
`
`
`
`PETITIONER:
`
`Stephen Y. Chow
`schow@burnslev.com
`Gabriel Goldman
`ggoldman@burnslev.com
`Ronda Moore
`rmoore@burnslev.com
`
`
`PATENT OWNER:
`
`Brian Nolan
`bnolan@mayerbrown.com
`Ying-Zi Yang
`yyang@mayerbrown.com
`Teeporn Tanpitukpongse
`ptanpitukpongse@mcciplaw.com
`Gregory Carlin
`gcarlin@mcciplaw.com
`Andrew Meunier
`dmeunier@mcciplaw.com
`
`
`
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`10
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