Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`Paper 18
`Entered: August 11, 2021
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`IPR2021-00406
`Patent 10,716,793 B2
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`
`
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, CHRISTOPHER M. KAISER,
`and DAVID COTTA, Administrative Patent Judges.
`
`KAISER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`Paper 18
`Entered: August 11, 2021
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, CHRISTOPHER M. KAISER,
`and DAVID COTTA, Administrative Patent Judges.
`
`KAISER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
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`
`INTRODUCTION
`
`A. Background
`Liquidia Technologies, Inc. (“Petitioner”) filed a Petition (Paper 2,
`“Pet.”) requesting an inter partes review of claims 1–8 of U.S. Patent
`No. 10,716,793 B2 (Ex. 1001, “the ’793 patent”). United Therapeutics
`Corporation (“Patent Owner”) filed a Preliminary Response. Paper 13
`(“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2020). The
`standard for instituting an inter partes review is set forth in 35 U.S.C.
`§ 314(a), which provides that an inter partes review may not be instituted
`unless “there is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.”
`After considering the Petition, the Preliminary Response, and the
`evidence of record, we determine that Petitioner has demonstrated a
`reasonable likelihood that it would prevail with respect to at least one
`challenged claim. Accordingly, we institute an inter partes review of all
`challenged claims on all asserted grounds.
`
`B. Related Matters
`The parties identify United Therapeutics Corporation v. Liquidia
`Technologies, Inc., 1:20-cv-00755-RGA (D. Del.) (“the District Court
`proceeding”), as a related matter. Pet. 1; Paper 3, 1.
`
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`C. The Asserted Grounds of Unpatentability
`Petitioner contends that claims 1–8 of the ’793 patent are unpatentable
`based on the following grounds (Pet. 30–68):1
`Claim(s) Challenged 35 U.S.C. §2
`1–8
`103
`1–8
`103
`1
`102
`1, 3, 8
`103
`1, 3
`102
`
`Reference(s)/Basis
`’212 patent,3 Voswinckel JESC,4
`Voswinckel JAHA5
`’212 patent, Voswinckel JESC
`Ghofrani6
`Voswinckel JAHA, Ghofrani
`Voswinckel 20067
`
`
`1 Petitioner also relies on declarations from Nicholas Hill, M.D., and Igor
`Gonda, Ph.D. Ex. 1002; Ex. 1004.
`2 The ’793 patent claims a priority date of May 15, 2006, and Petitioner
`“assumes the relevant priority date . . . is May 15, 2006.” Pet. 12; Ex. 1001,
`code (60). Accordingly, patentability is governed by the versions of
`35 U.S.C. §§ 102 and 103 preceding the amendments in the Leahy-Smith
`America Invents Act (“AIA”), Pub. L. No. 112–29, 125 Stat. 284 (2011).
`3 US 6,521,212 B1, issued Feb. 18, 2003 (Ex. 1006) (alleged to be prior art
`under 35 U.S.C. §§ 102(a), (b), (e)).
`4 Voswinckel, R., et al., Inhaled treprostinil is a potent pulmonary
`vasodilator in severe pulmonary hypertension, 25 EUROPEAN HEART J. 22
`(2004) (Ex. 1007) (alleged to be prior art under 35 U.S.C. § 102(b)).
`5 Robert Voswinckel, et al., Inhaled Treprostinil Sodium (TRE) For the
`Treatment of Pulmonary Hypertension, in Abstracts from the 2004 Scientific
`Sessions of the American Heart Association, 110 CIRCULATION III-295 (Oct.
`26, 2004) (Ex. 1008) (alleged to be prior art under 35 U.S.C. § 102(b)).
`6 Hossein Ardeschir Ghofrani, et al., Neue Therapieoptionen in der
`Behandlung der pulmonalarteriellen Hypertonie, 30 HERZ 296–302 (June
`2005) (Ex. 1010) (alleged to be prior art under 35 U.S.C. § 102(a)). We rely
`on the English translation that follows the German original article as part of
`Ex. 1010.
`7 Robert Voswinckel, et al., Inhaled Treprostinil for Treatment of Chronic
`Pulmonary Arterial Hypertension, 144 ANNALS OF INTERNAL MEDICINE
`
`3
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`
`Claim(s) Challenged 35 U.S.C. §2
`2, 4–8
`103
`
`Reference(s)/Basis
`Voswinckel 2006, ’212 patent
`
`D. The ’793 Patent
`The ’793 patent, titled “Treprostinil Administration by Inhalation,”
`issued on July 21, 2020. Ex. 1001, codes (45), (54). The patent “relates to
`methods and kits for therapeutic treatment and, more particularly, to
`therapeutic methods involving administering treprostinil using a metered
`dose inhaler and related kits.” Id. at 1:20–23.
`Treprostinil “is a prostacyclin analogue” that may be used to treat
`pulmonary hypertension. Id. at 5:37–41. According to the ’793 patent, it
`was previously known to administer treprostinil by intravenous,
`subcutaneous, or inhalation routes to treat any of several conditions,
`including pulmonary hypertension. Id. at 5:42–58.
`The ’793 patent relates to the administration of treprostinil in high
`concentrations over a short inhalation time. Id. at 16:61–63, 17:44–46. This
`method of administration is described as reducing pulmonary vascular
`resistance and pulmonary artery pressure, as well as increasing cardiac
`output. Id. at 16:32–42, Fig. 10.
`
`E. Illustrative Claim
`Claims 1–8 of the ’793 patent are challenged. Claim 1 is independent
`and illustrative; it recites:
`1. A method of treating pulmonary hypertension
`comprising administering by inhalation to a human
`suffering from pulmonary hypertension a
`therapeutically effective single event dose of a
`
`149–50 (January 2006) (Ex. 1009) (alleged to be prior art under 35 U.S.C.
`§ 102(a)).
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`formulation comprising treprostinil or a
`pharmaceutically acceptable salt thereof with an
`inhalation device, wherein the therapeutically
`effective single event dose comprises from 15
`micrograms to 90 micrograms of treprostinil or a
`pharmaceutically acceptable salt thereof delivered
`in 1 to 3 breaths.
`Ex. 1001, 18:23–31.
`
`ANALYSIS
`
`A. Claim Construction
`In an inter partes review, we construe a claim in an unexpired patent
`“in accordance with the ordinary and customary meaning of such claim as
`understood by one of ordinary skill in the art and the prosecution history
`pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020). “[T]he ordinary
`and customary meaning of a claim term is the meaning that the term would
`have to a person of ordinary skill in the art in question at the time of the
`invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005)
`(en banc). “Importantly, the person of ordinary skill in the art is deemed to
`read the claim term not only in the context of the particular claim in which
`the disputed term appears, but in the context of the entire patent, including
`the specification.” Id.
`Neither party presents any terms for construction. Pet. 12–13; Prelim.
`Resp. 1–56. Accordingly, we determine that no express construction of any
`claim term is necessary in order to decide whether to institute trial. Nidec
`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
`(Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
`795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in
`controversy, and only to the extent necessary to resolve the controversy.”)).
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`B. Discretionary Denial
`Patent Owner argues that we should exercise discretion to deny
`institution, either under 35 U.S.C. § 314(a) or under 35 U.S.C. § 325(d).
`Prelim. Resp. 9–26. Petitioner disagrees. Pet. 4–11.
`
`35 U.S.C. § 314(a) Discretion
`1.
`Institution of inter partes review is discretionary:
`The Director may not authorize an inter partes review to be
`instituted unless the Director determines that the information
`presented in the petition filed under section 311 and any
`response filed under section 313 shows that there is a
`reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.
`
`35 U.S.C. § 314(a). This language provides the Director with discretion to
`deny institution of a petition. See Cuozzo Speed Techs., LLC v. Lee, 136 S.
`Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is a
`matter committed to the Patent Office’s discretion.”); Patent Trial and
`Appeal Board Consolidated Trial Practice Guide (“CTPG”) at 55 (November
`2019), available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`The Director has delegated his authority under § 314(a) to the Board. 37
`C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”).
`The Leahy-Smith America Invents Act was “designed to establish a
`more efficient and streamlined patent system that will improve patent quality
`and limit unnecessary and counterproductive litigation costs.” H.R. Rep.
`No. 112−98, pt. 1, at 40 (2011), 2011 U.S.C.C.A.N. 67, 69 (reviews were
`meant to be “quick and cost effective alternatives to litigation”); see also
`S. Rep. No. 110−259, at 20 (2008); CTPG 56. The Board recognized these
`goals, but also “recognize[d] the potential for abuse of the review process by
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`repeated attacks on patents.” General Plastic Co., Ltd. v. Canon Kabushiki
`Kaisha, IPR2016-01357, Paper 19, 16−17 (PTAB Sept. 6, 2017)
`(precedential).
`In NHK Spring Co., Ltd. v. Intri-Plex Technologies, Inc., IPR2018-
`00752, Paper 8 (PTAB Sept. 12, 2018) (precedential), the Board determined
`that the advanced state of a parallel proceeding is an additional factor
`weighing in favor of denying institution under 35 U.S.C. § 314(a). Id. at 19–
`20. In Apple Inc. v. Fintiv, Inc., IPR2020-00019 (“Fintiv”), Paper 11, the
`Board articulated a list of factors that we consider in determining whether to
`exercise discretion to deny institution based on an advanced stage of a
`parallel proceeding:
`1. whether the court granted a stay or evidence exists that one
`may be granted if a proceeding is instituted;
`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline for a final written decision;
`3. investment in the parallel proceeding by the court and the
`parties;
`4. overlap between issues raised in the petition and in the parallel
`proceeding;
`5. whether the petitioner and the defendant in the parallel
`proceeding are the same party; and
`6. other circumstances that impact the Board’s exercise of
`discretion, including the merits.
`Fintiv, Paper 11, at 5–6. “These factors relate to whether efficiency,
`fairness, and the merits support the exercise of authority to deny institution
`in view of an earlier trial date in the parallel proceeding.” Id. In evaluating
`these factors, we take “a holistic view of whether efficiency and integrity of
`the system are best served by denying or instituting review.” Id. (citing
`CTPG 58).
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`
`Patent Owner has asserted the ’793 patent against Petitioner in the
`District Court proceeding. Pet. 1; Paper 3, 1. Given the status of the District
`Court proceeding, Patent Owner argues that we should exercise discretion
`under Fintiv to deny institution. Prelim. Resp. 9–26. We discuss the Fintiv
`factors below.
`
`a. First Fintiv Factor: Existence or Likelihood of Stay
`Patent Owner contends that this factor weighs in favor of denial.
`Prelim. Resp. 13–14. Patent Owner contends that Petitioner has not
`requested a stay of the District Court proceeding, and there is no reason to
`believe that a stay would be granted if it were requested. Id. In support of
`this assertion, Patent Owner argues that there are patents at issue in the
`District Court proceeding on which the Board has denied institution of inter
`partes review, leaving the District Court as the only forum in which the
`invalidity of those patents may be adjudicated. Id. Petitioner does not
`address this Fintiv factor. Pet. 4–6.
`With regard to the first Fintiv factor, Petitioner has not requested a
`stay of the District Court proceeding, and if such a request is subsequently
`made, we decline to speculate on the likelihood of a stay being granted. For
`these reasons, we determine that this factor is neutral.
`
`b. Second Fintiv Factor: Proximity of Anticipated Trial
`Date and Statutory Deadline for Final Written
`Decision
`Patent Owner contends this factor also weighs in favor of denial,
`because the presently scheduled trial in the District Court proceeding—a
`three-day trial beginning March 28, 2022—will occur roughly four and a
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`half months8 before the projected due date for the Board’s Final Written
`Decision on August 17, 2022. Prelim. Resp. 14–16. Petitioner does not
`address this factor. Pet. 4–6.
`Based on the current trial schedule, there is a relatively high
`likelihood that the District Court will reach its invalidity determination
`before we issue our Final Written Decision resolving Petitioner’s
`unpatentability allegations. Thus, we determine that the second Fintiv factor
`weighs in favor of exercising our discretion to deny institution under
`§ 314(a).
`
`c. Third Fintiv Factor: Investment in Parallel Proceeding
`Under this factor, we first consider Petitioner’s timing in filing the
`Petition. If a petitioner, “faced with the prospect of a looming trial date,
`waits until the district court trial has progressed significantly before filing a
`petition,” that decision “may impose unfair costs to a patent owner.”
`Fintiv, Paper 11, at 11. On the other hand, “[i]f the evidence shows that the
`petitioner filed the petition expeditiously, such as promptly after becoming
`aware of the claims being asserted, this fact has weighed against exercising
`the authority to deny institution.” Id.
`Petitioner asserts that it filed this Petition “within three months of
`receiving [Patent Owner’s] infringement contentions.” Pet. 4. Patent Owner
`argues that this three-month delay “can hardly be referred to as
`
`
`8 Patent Owner describes the March 2022 trial as scheduled for “six months
`before the Board’s expected statutory deadline.” Prelim. Resp. 15 (emphasis
`in original). The actual time between the conclusion of the scheduled
`District Court trial, i.e., March 30, 2022, and the latest date on which the
`Board’s Final Written Decision could be due is four months and 18 days.
`Accordingly, we analyze this issue based on that anticipated time frame.
`
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`‘expeditious[]’ or ‘diligent[].’” Prelim. Resp. 18 (quoting Fintiv, Paper 11,
`11–12 (alterations in original)). Beyond these bare allegations, neither party
`explains why the facts here suggest either expeditiousness or lack thereof.
`Pet. 4; Prelim. Resp. 18. We find no unreasonable delay in Petitioner’s
`filing.
`Second, we consider “the amount and type of work already completed
`in the parallel litigation by the court and the parties at the time of the
`institution decision.” Fintiv, Paper 11, at 9. “Specifically, if, at the time of
`the institution decision, the district court has issued substantive orders
`related to the patent at issue in the petition, this fact favors denial.” Id. at 9–
`10.
`
`Petitioner contends this factor weighs in favor of institution, because
`“the parties have just begun claim construction proceedings in the district
`court litigation, have not yet taken any depositions, and have conducted only
`the initial minimum required discovery.” Pet. 5. Patent Owner argues that
`this factor weighs against institution because “a claim construction hearing
`is currently scheduled for June 4, 2021,” and because “the court [likely] will
`also enter a Claim Construction Order in the case prior to the Board’s
`decision on institution.” Prelim. Resp. 17. In addition, Patent Owner notes
`that the District Court already has entered an order on a substantive issue,
`namely an order denying Patent Owner’s motion to dismiss Petitioner’s
`invalidity counterclaims due to assignor estoppel. Id. (citing Ex. 1014).
`Although we appreciate that a Markman hearing has been held, we
`find no evidence in the record that any substantive determinations on
`validity issues have been made in the District Court proceeding. In some
`respects, the present circumstances are similar to those in Sand Revolution
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`II, LLC v. Continental Intermodal Group-Trucking LLC, IPR2019-01393,
`Paper 24 (PTAB June 16, 2020) (informative) (Sand Revolution”), in which,
`as here, the parties exchanged preliminary infringement and invalidity
`contentions, and the district court conducted a Markman hearing. Id. at 10.
`The Sand Revolution panel found that, “aside from the district court’s
`Markman Order, much of the district court’s investment relates to ancillary
`matters untethered to the validity issue itself” and “much work remains in
`the district court case as it relates to invalidity: fact discovery is still
`ongoing, expert reports are not yet due, and substantive motion practice is
`yet to come.” Id. at 10–11. One difference between the present case and
`Sand Revolution is that neither party here has directed us to the entry of a
`Markman order by the District Court. In fact, as Patent Owner admits, “the
`parties to the Delaware Litigation are not disputing any claim terms at issue
`in the ’793 patent,” so even the entry of such an order would not materially
`advance the resolution of any invalidity issue related to the ’793 patent.
`Prelim. Resp. 17. Moreover, here, as in Sand Revolution, much work
`remains to be done in the district court. Fact discovery will continue until
`September 17, 2021, and dispositive motions will not be filed until
`November 2, 2021. Id. at 11.
`On balance, given the timeliness of the Petition and the level of
`investment of time and resources in the District Court proceeding, coupled
`with the absence of any substantive determinations on validity issues by the
`court, we find that this factor weighs against exercising our discretion to
`deny institution under § 314(a).
`
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`
`d. Fourth Fintiv Factor: Overlap Between Issues Raised
`in Petition and in Parallel Proceeding
`Patent Owner contends this factor favors denial of institution, because
`“[e]ach of the asserted claims in the Delaware Litigation is the subject of this
`Petition,” and especially because both proceedings address claim 1 of the
`’793 patent, the only independent claim. Prelim. Resp. 21. Patent Owner
`also argues that this factor favors denial of institution because “[t]hree of the
`five references in the Petition are also asserted in Liquidia’s Preliminary
`Invalidity Contentions in the Delaware Litigation.” Id. at 21–22. Petitioner
`argues that this factor favors institution because three of the eight claims
`challenged here are not challenged in the District Court proceeding. Pet. 5.
`We note first that neither party cites any evidence in support of its
`allegations regarding overlapping issues. Petitioner states that claims are
`challenged here that are not challenged in the District Court proceeding but
`cites no support at all for this position. Id. Patent Owner, meanwhile, cites
`exhibits that provide the dates of service of the parties’ preliminary
`infringement and invalidity contentions but does not direct us to the
`invalidity contentions themselves. Prelim. Resp. 12 (citing Exs. 2022–
`2023). In arguing that “[t]here is substantial overlap in the issues relating to
`the present matter and the Delaware Litigation,” Patent Owner cites no
`sources at all. Id. at 21–22. Given the lack of evidence supporting either
`party’s position, we cannot determine whether there is substantial overlap—
`or, indeed, any overlap at all—between the unpatentability issues raised here
`and the invalidity issues raised in the District Court proceeding.
`If we ignore the lack of evidence and take the parties’ allegations at
`face value, there seems to be at least some overlap between the issues raised
`here and the issues raised in the District Court proceeding. But, by Patent
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`Owner’s own admission, there are claims challenged here that are not
`challenged in the parallel litigation, and there are prior-art references
`asserted here that are not asserted in the District Court proceeding. Id. The
`overlap is, at most, not total, and it may or may not be substantial.
`In addition to the arguments regarding the overlap of issues, Petitioner
`argues that Patent Owner has raised assignor estoppel in the District Court
`proceeding as a way to block Petitioner’s assertion of invalidity, which may
`preclude Petitioner from litigating these issues in any forum other than
`before the Board. Pet. 5. In response, Patent Owner stipulates that, if we
`exercise discretion under § 314(a) to deny institution, Patent Owner will not
`raise its assignor estoppel arguments in the District Court proceeding.
`Paper 16, 1–2.
`Given the lack of evidence supporting either party’s position on the
`overlap of issues, and given that, even according to the parties’ unsupported
`arguments, there may not be substantial overlap of issues, this stipulation
`does not affect our analysis of the fourth Fintiv factor. There are three
`possibilities to consider. First, Patent Owner may decline to raise its
`assignor estoppel arguments. In that case, Petitioner would continue to press
`whatever invalidity arguments it has raised in the District Court proceeding,
`but we cannot determine on the present record how substantial the overlap is
`between those arguments and the unpatentability arguments raised here.
`Even if the District Court makes its decision before we issue a Final Written
`Decision, the District Court’s decision will not reach every issue that
`Petitioner raises here. Second, Patent Owner may continue to press its
`assignor estoppel argument and not prevail, leaving Petitioner free to raise
`the same invalidity arguments. Again, we cannot determine whether and to
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`what extent those arguments overlap with Petitioner’s unpatentability
`arguments. Finally, Patent Owner may prevail on its assignor estoppel
`argument. In that case, Petitioner would be barred from raising any
`invalidity arguments in the District Court proceeding, and the District Court
`would then have no opportunity to rule on invalidity, eliminating any
`overlap with the present proceeding. Patent Owner’s stipulation eliminates
`the possibility that Petitioner will not be able to challenge validity before the
`District Court, but cannot change the fact that the District Court’s decision
`will not reach every issue that Petitioner raises here.
`Thus, we find that there may be some overlap of issues between this
`proceeding and the District Court proceeding, but this overlap (1) is not total
`either in terms of claims challenged or in terms of references asserted, and
`(2) may or may not be substantial. Moreover, if we institute, and thus Patent
`Owner’s stipulation does not take effect, the overlap may disappear
`altogether, depending on the outcome of Patent Owner’s assignor estoppel
`argument. Accordingly, we find that this factor weighs against exercising
`discretion to deny institution.
`
`e. Fifth Fintiv Factor: Whether Petitioner and Parallel
`Proceeding Defendant Are Same
`The parties do not dispute that the same parties involved in the present
`proceeding are also involved in the District Court proceeding. Pet. 4–6;
`Prelim. Resp. 23–24. Thus, this factor weighs in favor of exercising our
`discretion to deny institution under § 314(a).
`
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`f. Sixth Fintiv Factor: Other Circumstances (Including
`Merits)
`Patent Owner argues that this factor favors denying institution,
`because Petitioner “has not set forth ‘sufficiently strong’ proposed grounds
`that would support a grant of institution. Prelim. Resp. 24–25. Petitioner
`argues to the contrary that “the merits of this Petition are strong,” both
`because the Board previously instituted review based on earlier petitions
`challenging related patents, and because the present Petition asserts a
`multiplicity of grounds challenging each claim. Pet. 5–6.
`We are not persuaded by either party’s argument. As discussed
`below, we determine that Petitioner’s case is strong enough to warrant
`institution of inter partes review, contradicting the basis of Patent Owner’s
`argument on this factor. Petitioner’s argument that the present petition is
`unusually strong because the Board previously instituted review on other
`petitions suffers from multiple defects. First, a petition that presents
`arguments strong enough to institute review is not necessarily a petition that
`is so strong as to trigger the sixth Fintiv factor. Second, the two petitions on
`which Petitioner’s argument rests both challenged patents other than the
`’793 patent challenged here. Third, the two petitions in question were filed
`by parties other than Petitioner. It is at best unclear why the Board’s
`determination to institute review on petitions brought by one party
`challenging certain claims in certain patents should mandate a determination
`that the merits of the present Petition, brought by a different party and
`challenging different claims of different patents, are so strong as to warrant
`weighing this factor in Petitioner’s favor. As for Petitioner’s argument that
`its assertion of multiple grounds to challenge each claim means the Petition
`is strong, we are not persuaded that the number of asserted grounds of
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`unpatentability, as opposed to the evidentiary support for and persuasive
`reasoning behind those grounds, is the proper basis on which to judge the
`strength of a petition.
`Because neither party presents a persuasive argument on the sixth
`Fintiv factor, we find that this factor is neutral with respect to exercising
`discretion to deny institution.
`
`g. Conclusion
`Because the analysis is fact-driven, no single factor is determinative
`of whether we exercise our discretion to deny institution under 35 U.S.C.
`§ 314(a).
`On this record, after weighing all of the factors and taking a holistic
`view, we determine that the facts in this case that weigh against exercising
`discretion outweigh the facts that favor exercising discretion. Accordingly,
`we determine that the circumstances presented weigh against exercising our
`discretion to deny institution under § 314(a).
`
`35 U.S.C. § 325(d) Discretion
`2.
`Patent Owner argues that we should exercise our discretion to deny
`institution under 35 U.S.C. § 325(d). Prelim. Resp. 25–26. Petitioner
`argues that we should not exercise such discretion. Pet. 6–11.
`Section 325(d) provides that the Director may elect not to institute a
`proceeding if the challenge to the patent is based on matters previously
`presented to the Office. 35 U.S.C. § 325(d) states, in pertinent part,
`In determining whether to institute or order a proceeding under
`this chapter, chapter 30, or chapter 31, the Director may take
`into account whether, and reject the petition or request because,
`the same or substantially the same prior art or arguments
`previously were presented to the Office.
`
`16
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`
`
`In deciding whether to exercise discretion to deny institution under
`§ 325(d), we use a two-part framework, determining first “whether the same
`or substantially the same art previously was presented to the Office or
`whether the same or substantially the same arguments previously were
`presented to the Office,” and second, “if either condition of first part of the
`framework is satisfied, whether the petitioner has demonstrated that the
`Office erred in a manner material to the patentability of challenged claims.”
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6, at 8 (PTAB Feb. 13, 2020) (precedential)
`(“Advanced Bionics”). To use this framework, we consider the factors set
`forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-
`01586, Paper 8, at 17–18 (Dec. 15, 2017) (precedential as to § III.C.5, first
`paragraph) (“Becton, Dickinson”). Specifically, we apply Becton, Dickinson
`factors (a), (b), and (d) to determine whether the same or substantially the
`same art or arguments previously were presented to the Office, and we apply
`Becton, Dickinson factors (c), (e), and (f) to determine whether Petitioner
`has demonstrated a material error by the Office. Advanced Bionics, at 10.
`We consider the relevant Becton, Dickinson factors below as part of the
`Advanced Bionics framework.
`
`a. Advanced Bionics Step One: Same or Substantially
`the Same Prior Art or Arguments Previously
`Presented to the Office
`In the first step of the Advanced Bionics framework, we determine
`whether the same or substantially the same prior art or arguments presented
`here previously were presented to the Office. We do so by examining three
`of the Becton, Dickinson factors: “(a) the similarities and material
`
`17
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`IPR2021-00406
`Patent 10,716,793 B2
`
`differences between the asserted art and the prior art involved during
`examination; (b) the cumulative nature of the asserted art and the prior art
`evaluated during examination;” and “(d) the extent of the overlap between
`the arguments made during examination and the manner in which Petitioner
`relies on the prior art or Patent Owner distinguishes the prior art.” Becton,
`Dickinson, at 17–18; see Advanced Bionics, at 10.
`Here, Petitioner admits that “[t]he art presented in this petition was
`listed in [Patent Owner’s] Information Disclosure Statement.” Pet. 7.
`“Previously presented art includes art . . . provided to the Office by an
`applicant, such as on an Information Disclosure Statement (IDS), in the
`prosecution history of the challenged patent.” Advanced Bionics, at 7–8.
`Accordingly, all of the art asserted against the ’793 patent here previously
`was presented to the Office.
`Given this, we evaluate Becton, Dickinson factors (a) and (b) as
`favoring a finding that the same or substantially the same prior art presented
`here previously was presented to the Office. The art presented here is not
`only similar to some art that was before the Office during examination, it is
`identical, and this identity means that there are no material differences
`between the art presented here and the art previously before the Office.
`
`b. Advanced Bionics Step Two: Material Error by the
`Office Shown
`Because we find that the same or substantially the same prior art
`presented here previously was presented to the Office, we proceed to the
`second step of the Advanced Bionics framework and determine whether
`Petitioner has demonstrated a material error by the Office. We do so by
`examining the three remaining Becton, Dickinson factors: “(c) the extent to
`
`18
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`IPR2021-00406
`Patent 10,716,793 B2
`
`which the asserted art was evaluated during examination, including whether
`the prior art was the basis for rejection;” “(e) whether Petitioner has pointed
`out sufficiently how the Examiner erred in its evaluation of the asserted prior
`art; and (f) the extent to which additional evidence and facts presented in the
`Petition warrant reconsideration of the prior art or arguments.” Becton,
`Dickinson, at 17–18; see Advanced Bionics, at 10.
`With respect to factor (c), Petitioner argues that “no prior art was
`substantively relied on during examination,” because the Office “only issued
`one substantive rejection during prosecution — for obviousness-type double
`patenting.” Pet. 8 (citing Ex. 1015, 24–28). Patent Owner does not address
`this factor directly, arguing only that “an analysis of each Becton factor is
`not necessary here.” Prelim. Resp. 25–26. On the present record, Petitioner
`appears to be correct: there was only a single substantive rejection, which
`did not rely on any of the prior-art references asserted here. Ex. 1015, 1–
`208. Because the art asserted here was not the basis for a rejection and was
`not evaluated substantively at all during examination, Becton, Dickinson
`factor (c) weighs in favor of a finding that Petitioner has shown material
`error by the Office.
`With respect to factors (e) and (f), the present Petition argues for the
`unpatentability of claims 1–8 on six grounds, using multiple combinations of
`references. As discussed in
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