UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`LIQUIDIA TECHNOLOGIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner
`
`Patent No. 10,716,793 B2
`
`Issue Date: July 21, 2020
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Partes Review No. IPR2021—00406
`
`
`DECLARATION OF DR. WERNER SEEGER
`
`IPR2021-00406
`United Therapeutics EX2003
`Page 1 of 16
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`LIQUIDIA TECHNOLOGIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner
`
`Patent No. 10,716,793 B2
`
`Issue Date: July 21, 2020
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Partes Review No. IPR2021—00406
`
`
`DECLARATION OF DR. WERNER SEEGER
`
`IPR2021-00406
`United Therapeutics EX2003
`Page 1 of 16
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`IPR2021-00406
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`Declaration of Dr. Werner Seeger
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`I, Dr. Werner Seeger, hereby declare as follows:
`
`I am a named inventor of US. Patent No. 10,716,793 (the “’793
`
`patent”) and am the director of University of Giessen and Marburg Lung Center
`
`(“UGMLC”), a research center at the University Hospital Giessen studying
`
`pulmonary hypertension.
`
`I am a paid consultant for United Therapeutics, which I understand is
`
`the assignee of the ”793 patent, in connection with IPR2021-00406. My
`
`compensation does not depend on the content of this declaration, the substance of
`
`any other testimony that I may offer in connection with this proceeding or the
`
`disposition of this proceeding.
`
`‘Ghofrani Review Article
`
`I am a co-author of the German language article: Hossein Ardeschi
`
`Ghofrani et al. “Neue Therapieoptionen in der Behandlung der pulmonalarteriellen
`
`Hypertonie,”1 Herz, 30, 4 (June 2005): 296—302 (“the Ghofrani article”). I
`
`understand that Liquidia Technologies, Inc. (“Liquidia”) submitted this publication
`
`along with an English language translation of the article in this proceeding as
`
`Exhibit 1010, which I have reviewed.
`
`1 The title is translated as “Pulmonary hypertension — new aspects of therapy” in
`
`Exhibit 1010.
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`IPR2021-00406
`United Therapeutics EX2003
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`IPR2021-00406
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`Declaration of Dr. Werner Seeger
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`The Ghofrani article was an overview review article, drafted under my
`
`direction and control by members of my research center at University Hospital
`
`Giessen. The intent of the article was to compile and review information, not to
`
`communicate primary data. Each of the listed authors was selected based on their
`
`expertise in particular areas covered in particular sections of the Ghofrani article.
`
`Dr. Hossein A. Ghofrani—the first listed author—has experience in
`
`the use of phosphodiesterase inhibitors for treatment of pulmonary hypertension.
`
`He drafted the section of the Ghofrani article relating to phosphodiesterase
`
`inhibitors. I know Dr. Ghofrani drafted this section of the Ghofrani article because
`
`I asked him to draft this section and communicated with him about it. In Exhibit
`
`1010, this section in English begins at the bottom of page 11 and continues through
`
`page 13. Dr. Ghofrani was listed as a co-author on the Ghofrani article because he
`
`drafted this portion of the article and the other portions noted below.
`
`Drs. Frank Reichenberger and Friedrich Grimminger both have
`
`experience in the use of selective endothelin A receptor agonists for treating
`
`pulmonary hypertension. I know Drs. Reichenberger and Grimminger drafted this
`
`section of the Ghofrani article because I asked them to draft this section and
`
`communicated with them about it. Together they drafted the section of the
`
`Ghofrani article relating to selective endothelin A receptor agonists. In Exhibit
`
`1010, this section is in English on page 11. Drs. Reichenberger and Grimminger
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`United Therapeutics EX2003
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`IPR2021-00406
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`Declaration of Dr. Werner Seeger
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`were listed as a co-author on the Ghofrani article because they drafted this portion
`
`of the article.
`
`Dr. Robert Voswinckel and I both have experience in the use of
`
`inhaled iloprost and inhaled treprostinil for treatment of pulmonary hypertension.
`
`Together, we drafted the sections of the Ghofrani article relating to inhaled iloprost
`
`and inhaled treprostinil. In Exhibit 1010, this section is in English and begins on
`
`page 10 and continues through page 11. (Ex. 1010, p. 11). Although the
`
`information in this excerpt for the article was compiled and composed by Dr.
`
`Voswinckel and myself, the individuals who designed the underlying clinical
`
`studies with inhaled treprostinil are the same as the ones listed as inventors on the
`
`patents, as explained in more detail below. We of course performed the studies
`
`discussed in the Ghofrani article, wrote the excerpt quoted above, and submitted it
`
`for publication before it was published in June 2005 based upon our work together
`
`designing the clinical study.
`
`The co—inventors designed the underlying clinical studies with inhaled
`
`treprostinil described in the following 2 sentences quoted above from the Ghofrani
`
`article: “Initial trials in Giessen have shown proof of efficacy of inhaled
`
`treprostinil for the effective reduction of the pulmonary vascular resistance (PVR)
`
`[6]. In this first study, 17 patients with severe pre-capillary pulmonary
`
`hypertension were administered inhaled treprostinil (15 mcg/inhalation).” The
`
`IPR2021-00406
`United Therapeutics EX2003
`Page 4 of 16
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`IPR2021-00406
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`Declaration of Dr. Werner Seeger
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`clinical trials referenced in the first sentence of this passage, which cites to the
`
`Voswinckel 2004 ESC abstract, involved 29 patients of different pulmonary
`
`hypertension categories and did not provide an inhaled dosage because it only
`
`gives concentration of drug in the inhaled solution. The second sentence of this
`
`passage from Ghofrani refers to a subgroup of 17 patients assumed to have
`
`received an inhaled dosage of 15 mcg.
`
`Regarding dosage of inhaled treprostinil, the Ghofrani review article
`
`notes that patients were “administered inhaled treprostinil (15 mcg/inhalation).”
`
`The word “inhalation” in that sentence (in both German and English) does not
`
`mean “breath,” but rather, refers to the overall inhalation event stretching over
`
`minutes. This is clear under our typical use of that terminology.
`
`10. With respect to the 29-patient study citing the reference of endnote
`
`“[6]” (Voswinckel 2004 ESC Abstract) for support, which used an inhalation
`
`period of six minutes (reference [6] of EX. 1010 is EX. 1007, and p. 5 of EX. 1007
`
`states that “6 min” was used), this indicates that a continuous nebulizer was being
`
`used where dose per breath is not measured (without pulsing or an opto—acoustical
`
`trigger), as in the first two studies using an unmodified OptiNeb® device discussed
`
`below (paragraph 24).
`
`11. Although the Ghofrani review article states that treprostinil showed a
`
`strong pulmonary selectivity “so that it is possible to increase the dosage to up to
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`IPR2021-00406
`United Therapeutics EX2003
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`lPR2021-00406
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`Declaration of Dr. Werner Seeger
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`90 mcg (absolute inhaled dose per inhalation exercise),” it does not report that this
`
`dosage was applied in human pulmonary hypertension patients, which is evident
`
`from reviewing the cited reference, “[6]” (Ex. 1007), in which this this dosage is
`
`not reported. Rather, the Ghofrani review article states only that it “is possible”
`
`(“moglich ist” in EX. 1010). This statement was intended to convey the idea that it
`
`may be possible to increase the dosage to that level, not that the referenced study
`
`actually performed that particular test. Similarly, the Ghofrani review article states
`
`that due to certain unique properties of treprostinil, “it is possible [“ist es
`
`m6glich”] to reduce the number [of] inhalations necessary to up to four per day”
`
`and that the inhalation period “can be” reduced [“lasst sich bei”] to < 1 min. and
`
`that it “is technically feasible [“technisch realisierbar sein wird”] for there to [sic]
`
`only one to two breaths in an application.” EX. 1010, p. 3, 11. These statements of
`
`possibilities do not report any conclusion of studies performed, which is evident
`
`from reviewing the cited reference, in which 6 min inhalation time was reported
`
`“[6]” (EX. 1007), but rather, suggest only future paths for clinical studies.
`
`In sum, the Ghofrani review article does not explain or teach any
`
`particular therapeutic regimen or necessary parameters. It does not present any new
`
`treprostinil inhalation results, but rather, it only is summarizing the results and
`
`merely provides a high-level overview of early investigations into inhaled
`
`treprostinil and some speculation for additional research. Similarly, the two
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`Declaration of Dr. Werner Seeger
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`Voswinckel references provided by Liquidia as Exs. 1007 and 1008, both of which
`
`are abstracts and not primary study reports, report only select and incomplete
`
`information of different studies. Although the specific parameters used and
`
`particulars of the studies performed by my group are not fully reported, any study
`
`that formed the basis of our discussion of inhaled treprostinil in these three
`
`references (EX. 1007, 1008, and 1010) was performed by me in conjunction with
`
`my ongoing collaboration with Drs. Voswinckel, Olschewski, Rubin, Schmehl,
`
`Sterritt, and Roscigno. Indeed, in both Voswinckel abstracts at EX. 1007 and EX.
`
`1008 we note that the study was “supported by Lung RX.” In particular, as to any
`
`of these relevant inhalation studies with inhaled treprostinil, Drs. Voswinckel,
`
`Olschewski, Rubin, Schmehl, Sterritt, and Roscigno, and 1 determined the dosage
`
`amounts of administered inhaled treprostinil to give to patients, determined the
`
`inhalation time and/or number of breaths employed, determined what equipment
`
`and administration devices and methods to use, and identified the spacing between
`
`inhalation events, as well as analyzed the hemodynamic and pharmacokinetic
`
`effects over time. The other authors listed in the Ghofrani review article—Drs.
`
`Ghofrani, Reichenberger, and Grimminger——did not participate in the design of
`
`any of the studies, did not select the dosing regimen, and did not conduct analysis
`
`of patient results discussed in the Ghofrani review article or the two Voswinckel
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`IPR2021-00406
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`IPR202l-00406
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`Declaration of Dr. Werner Seeger
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`Drs. Ghofrani, Reichenberger, and Grimminger were named as co-
`
`authors because it was, and continues to be, the practice of our group, as an
`
`academic and research group, to include as co-authors all individuals working in
`
`our group that run the center, assist with trials, and engage in clinical routine
`
`management and administration, even when that group is broader than the
`
`individuals actually involved in inventing methods or devices and designing the
`
`trials. More specifically, even though Drs. Ghofrani, Reichenberger, and
`
`Grimminger did not design the inhaled treprostinil clinical trials, they did perform
`
`support work including help with identifying potentially eligible patients out of the
`
`group of patients in our pulmonary hypertension clinic. Because patients with
`
`severe pulmonary hypertension have multiple needs beyond their participation in
`
`clinical trials, such as treatments involving their background medications (e.g.,
`
`diuretics, anti-coagulation, other pulmonary hypertension targeted co-medications,
`
`antibiotics, etc.); and support for some general needs (e.g., administrative matters
`
`with insurance or helping with other family members, etc.), they also carried out
`
`this type of work. In still other cases, patients who discontinued clinical trials
`
`require immediate transitioning back to their normal clinical care again, which was
`
`also part of their responsibilities.
`
`In sum, the information in Ghofrani was compiled and composed by
`
`Dr. Voswinckel and myself. The idea to perform the underlying work described in
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`IPR2021-00406
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`IPR202l-00406
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`Declaration of Dr. Werner Seeger
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`this section originated with Dr. Voswinckel and myself, in view of our work with
`
`other inventors listed on the ’507 patent. The other authors listed in the Ghofrani
`
`article—Drs. Ghofrani, Reichenberger and Grimminger—did not contribute to this
`
`excerpt or the underlying work.
`
`The remaining sections on vasoactive therapy, inhaled iloprost,
`
`combination therapies, and treatment of pulmonary hypertension, as well as the
`
`introduction and compiled literature were drafted by Dr. Hossein A. Ghofrani and
`
`Upon completion of the draft and prior to submission thereof, I
`
`reviewed and edited the Ghofrani article in my capacity as director of my research
`
`center. In addition to myself, the four members of my research center who had
`
`contributed to the aforementioned sections of the Ghofrani article were listed as
`
`The selection of authors for the Ghofrani article fits with the normal
`
`practice in my research center. In general, when my research center submits
`
`abstracts to a conference or articles for publication, we include members of the
`
`research group who contributed in some way to the abstract or article as authors.
`
`[Voswinckel 2006 Clinical Observation Letter
`
`I am listed as a co-author of the clinical observation letter: Robert
`
`Voswinckel, Hossein A. Ghofrani, Friedrich Grimminger, Werner Seeger, and
`
`IPR2021-00406
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`IPR2021-00406
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`Declaration of Dr. Werner Seeger
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`Horst Olschewski, “Clinical Observations” on “Inhaled Treprostinil for Treatment
`
`of Chronic Pulmonary Arterial Hypertension,” “Letters” Section of the Annals of
`
`Internal Medicine, l44(2):l49-50 (January 2006) (“Voswinckel 2006”).
`
`I
`
`understand that Liquidia submitted the letter in this proceeding as Exhibit 1009,
`
`which I have reviewed.
`
`19. Voswinckel 2006, which is a clinical observation letter, characterizes
`
`the effects of inhaled treprostinil with special regard to safety, tolerability, and
`
`efficacy in patients with severe pulmonary arterial hypertension. EX. 1009, p. 6.
`
`Although the specific parameters used and particulars of the studies performed by
`
`my group are not fully reported in Voswinckel 2006 (e.g., “modified OptiNeb
`
`ultrasonic device”), any study that formed the basis of our discussion of inhaled
`
`treprostinil in this reference was performed by me in conjunction with my ongoing
`
`collaboration with Drs. Voswinckel, Olschewski, Rubin, Schmehl, Sterritt, and
`
`Roscigno. Indeed, we note that Lunng provided a grant for this research. EX.
`
`1009, p. 6.
`
`In particular, as to the study with inhaled treprostinil in Voswinckel
`
`2006, Drs. Voswinckel, Olschewski, Rubin, Schmehl, Sterritt, and Roscigno, and I
`
`determined the dosage amounts of administered inhaled treprostinil to give to
`
`patients, determined the inhalation time and/or number of breaths employed,
`
`determined what equipment and administration devices and methods to use, and
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`Declaration of Dr. Werner Seeger
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`identified the spacing between inhalation events, as well as analyzed the
`
`hemodynamic and pharmacokinetic effects over time. The other authors listed in
`
`Voswinckel 2006—Drs. Ghofrani and Grimminger—did not participate in the
`
`design of any of the studies, did not select the dosing regimen, and did not conduct
`
`analysis of patient results discussed in the Ghofrani review article, the two
`
`Voswinckel abstracts or the Voswinckel 2006 Clinical Observation Letter.
`
`Drs. Ghofrani and Grimminger were named as co-authors because it
`
`was, and continues to be, the practice of our group, as an academic and research
`
`group, to include as co-authors all individuals working in our group that run the
`
`center, assist with trials, and engage in clinical routine management and
`
`administration, even when that group is broader than the individuals actually
`
`involved in inventing methods or devices and designing the trials. Unlike the
`
`earlier abstracts and review article, Dr. Reichenberger was not included as an
`
`author on Voswinckel 2006 because he was no longer member of the particular
`
`research/medical group caring about inhalation strategies in pulmonary
`
`hypertension patients at that time. More specifically, even though Drs. Ghofrani
`
`and Grimminger did not design the inhaled treprostinil clinical trials, they did
`
`perform support work including help with identifying potentially eligible patients
`
`out of the group of patients in our pulmonary hypertension clinic. Because patients
`
`with severe pulmonary hypertension have multiple needs beyond their participation
`
`IPR2021-00406
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`IPR202l-00406
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`Declaration of Dr. Werner Seeger
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`in clinical trials, such as treatments involving their background medications (e.g.,
`
`diuretics, anti-coagulation, other pulmonary hypertension targeted co-medications,
`
`antibiotics, etc.); and support for some general needs (e.g., administrative matters
`
`with insurance or helping with other family members, etc), they also carried out
`
`this type of work. In still other cases, patients who discontinued clinical trials,
`
`require immediate transitioning back to their normal clinical care again, which was
`
`also part of their responsibilities.
`
`MV Collaboration with Drs. Rubin. Voswinckel. Olschewski. Schmehl.
`
`Roscigno. and Sterritt
`
`Dr. Voswinckel and my collaboration with Drs. Rubin and
`
`Olschewski and Lung Rx began in 2003. On September 30, 2003, I entered into a
`
`Services Agreement with Lung Rx, Inc. under which I served as co—chair with Dr.
`
`Lewis Rubin for the development program for treprostinil inhalation. A true and
`
`correct copy of this Agreement is appended to this declaration. As reflected in the
`
`Services Agreement itself, work included developing the outline and timeline for
`
`the development program, and also designing the pilot and pivotal trials. Id. I
`
`worked directly with Drs. Rubin, Voswinckel, Olschewski, Schmehl, Roscigno,
`
`and Sterritt on this collaboration, which resulted in the three clinical studies
`
`mentioned below that became the basis of our patent application leading to the
`
`”793 patent.
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`Declaration of Dr. Werner Seeger
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`In particular, I recall a meeting in New York on 22 October 2003,
`
`which included me, Dr. Rubin, and Dr. Olschewski, as well as participants from
`
`United Therapeutics, and together we discussed the design of clinical trials with
`
`inhaled treprostinil to treat pulmonary hypertension patients. A true and correct
`
`copy of the agenda from this meeting, which describes a detailed work plan, is
`
`appended to this declaration. Certain action items indicated in this agenda involved
`
`me or my co-inventors as reflected by our initials (“LR” is Lewis Rubin, “WS” are
`
`my initials, “H0” is Horst Olschewski, “RR” is Robert Roscigno, and “CS” is Carl
`
`Following this initial meeting in New York, my co-inventors and I
`
`investigated various devices and alternatives to deliver inhaled treprostinil as
`
`described in our patent application. One possible method involved the use of a
`
`particular kind of metered dose inhaler, as discussed in our provisional US.
`
`Application No. 60/800,016 (the “’016 application”) at par. [0037] and [0047]—
`
`[0055]. A different, and unrelated, alternative was the use of an ultrasonic
`
`nebulizer (id. at [0066]). We began a series of studies with a particular ultrasonic
`
`nebulizer called the OptiNeb® device, which are summarized in our patent
`
`application (id. at [0062]—[0089]). The first two studies initially used a 6 min.
`
`inhalation period, meaning that patients breathed continuously while nebulization
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`occurred over this time period, without pulsing of aerosol generation and without
`
`an opto-acoustical trigger (see ’016 application, par. [0066], [0070], and [0071]).
`
`Unexpectedly, when we used treprostinil at a much higher dose in our
`
`second study with the OptiNeb® ultrasonic nebulizer device, we discovered that
`
`treprostinil has a slower transpulmonary transit time (time of drug “spillover” into
`
`the blood to reach peak plasma concentration) of 10 to 15 minutes when
`
`administered to pulmonary hypertension patients (id. at Fig. 12), compared to
`
`iloprost. See Olschewski, et al., Pharmacodynamics and Pharmacokinetics of
`
`Inhaled Iloprost, Aerosolized by Three Different Devices, in Severe Pulmonary
`
`Hypertension, Chest J ., 124(4), 1294-1304, 1294 (Oct. 2003) (“rapid entry of
`
`iloprost into the systemic circulation was noted, peaking immediately after
`
`termination of the inhalation maneuver”). This particular pharmacokinetic data is
`
`disclosed in our patent application (see ’016 application at Fig. 12), but is not
`
`reported in either of the Voswinckel abstracts (Exs. 1007 and 1008), Voswinckel
`
`2006 (E. 1009), or the Ghofrani publication (EX. 1010). This slower time to reach
`
`peak plasma concentration is important. It obviously allows: a) to avoid major
`
`systemic side effects even when high total inhalation doses are used (nevertheless
`
`the high local concentrations in the lung already provide the desired therapeutic
`
`effect); b) to reduce the inhalation time to even a few breaths (made possible by
`
`switching to a pulsed ultrasonic nebulizer in the further course of the studies); and
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`Declaration of Dr. Werner Seeger
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`c) to increase the overall inhaled treprostinil dose more than one order of
`
`magnitude over the overall inhaled tolerable iloprost dose.
`
`In a subsequent trial, we modified the OptiNeb® device to include both
`
`pulsing and an opto-acoustical trigger, while using a high enough concentration of
`
`pre-aerosolized treprostinil solution to permit high dosing in a small number of
`
`breaths coordinated with each of the aerosol pulses (EX. 2100, par. [0072], [0079]—
`
`[0081] and [0088]), which dramatically shortened the overall time of each
`
`treatment session. Drs. Voswinckel, Olschewski, Schmehl and I were involved in
`
`guiding the design of these changes to the OptiNeb® device and working to
`
`implement them into the treatment regimen. The co—inventors and I, therefore, had
`
`to work directly with Nebu-tec®, the manufacturer of the OptiNeb® device, to guide
`
`modifying the device to achieve all of the necessary features. Because we moved
`
`to such a high concentration of treprostinil in the aerosol, the opto-acoustical
`
`trigger to guide the patient's breathing and synchronize it to each pulse of aerosol
`
`was especially important. To my knowledge, the OptiNeb® device we created was
`
`not one that was publicly available or otherwise publicly disclosed prior to our
`
`patent application. Although the Voswinckel JESC publication references a
`
`“pulsed” OptiNeb® nebulizer (EX. 1008, p. 3), it does not disclose any of the
`
`modifications we made, including the opto-acoustical trigger for coordinating each
`
`patient’s breath with each pulse of aerosol at these high treprostinil concentrations.
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`Declaration of Dr. Werner Seeger
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`In sum, while my collaboration with Drs. Rubin, Voswinckel,
`
`Olschewski, Schmehl, Roscigno, and Sterritt was the basis of our patent
`
`application leading to the ’793 patent, the collaboration did not necessarily result in
`
`their inclusion on a review article, abstracts having incomplete information or
`
`clinical observation letters.
`
`I hereby declare that all statements made herein of my knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both
`
`under Section 1001 of Title 18 of the United States Code.
`
`“ML,
`5‘4:
`
`”4
`
`V
`
`,2021
`
`Dr. Werner Seeger
`
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