UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No. AKBM-33544
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`
`
`Case IPR2014-00003
`Patent 8,278,351 B1
`
`
`
`PETITIONER AKER BIOMARINE AS’S MOTION FOR REHEARING
`UNDER 37 C.F.R. § 42.71
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`Attorney Docket No. AKBM-33544
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`
`
`Case IPR2014-00003
`Patent 8,278,351 B1
`
`
`
`PETITIONER AKER BIOMARINE AS’S MOTION FOR REHEARING
`UNDER 37 C.F.R. § 42.71
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`On March 24, 2014, the Patent Trial and Appeal Board (“Board”) instituted
`
`this inter partes review of certain claims of U.S. Patent No. 8,278,351 (“the ’351
`
`patent”) on two grounds: (1) anticipation of claims 1, 3-6, 9, 12, 13, 19-24, 26-29,
`
`32, 35, 36, and 42-46 by Beaudoin I; and (2) obviousness of claims 1-6, 9, 12, 13,
`
`19-29, 32, 35, 36, and 42-46 over the combination of Fricke, Bergelson, Yasawa,
`
`Itano, and the WHO Bulletin. Paper 22 at 28. Although the Board instituted an
`
`inter partes review of every other claim subject to Aker BioMarine AS’s (“Aker”)
`
`petition1 based on anticipation of those claims by Beaudoin I, the Board
`
`“decline[d] to institute an inter partes review of claims 2 and 25 under 35 U.S.C.
`
`§ 102(b) as anticipated by Beaudoin I.” Id. Because Beaudoin I also discloses
`
`every limitation of claims 2 and 25, and because the Board’s decision to the
`
`contrary rests upon legal error, Aker respectfully requests that the Board reconsider
`
`its refusal to institute a review of claims 2 and 25 as anticipated by Beaudoin I.
`
`Claims 2 and 25 of the ’351 patent, which are generally directed to a krill
`
`extract, state that “the extract has a total phospholipid concentration in an amount
`
`
`1 Aker’s petition originally requested review of claims 1-94 of the ’351 patent, but
`
`the Board granted the parties’ joint motion to limit the claims to those identified
`
`above. Paper 21.
`
`
`
`1
`
`
`
`
`
`of about 40% w/w, wherein about represents ± 10%.” Ex. 1001. As found by the
`
`Board in its decision instituting this inter partes review, “about 40% w/w, wherein
`
`about represents ± 10%” means “from 30% to 50%.” Paper 22 at 17. In its
`
`petition, Aker explained that claims 2 and 25 were anticipated by Beaudoin I
`
`because Table 14 in that reference expressly “discloses 54.1 ± 6.1% phospholipids
`
`and polar material w/w in Fraction I extracts, which falls within or touches the
`
`claimed ranges.” Paper 4 at 20; Paper 22 at 17. The Board declined to review
`
`claims 2 and 25 on this ground, however, stating that “[w]hile it is possible that
`
`54.1 ± 6.1% included 48% to 50%, which would have fallen within the recited
`
`range,” the Board was not persuaded that the amount disclosed in Table 14 of
`
`Beaudoin I “necessarily included such an amount.” Paper 22 at 17.
`
`The Board committed two legal errors in declining to review claims 2 and 25
`
`for anticipation by Beaudoin I. First, the Board incorrectly applied the standard for
`
`inherent anticipation in requiring that Beaudoin I must “necessarily include[]” the
`
`claimed phospholipid concentration. In doing so, the Board overlooked that
`
`Beaudoin I explicitly discloses a phospholipid concentration within the claimed
`
`range, and therefore anticipates claims 2 and 25 under controlling precedent.
`
`Paper 4 at 20. Second, the Board’s decision contravenes In re Best, 562 F.2d 1252
`
`(C.C.P.A 1977). The Board adopted Aker’s argument that because “the processes
`
`described in the ’351 patent and . . . the prior art [Beaudoin I] are virtually
`
`
`
`2
`
`
`
`
`
`indistinguishable,” as a result so, too, “would be the resulting extracts.” Paper 4 at
`
`12; Paper 22 at 13. Accordingly, a prima facie case of anticipation (and
`
`obviousness) has been established and the burden shifted to Neptune to produce
`
`evidence as to why the resulting compositions would be different. See Best, 562
`
`F.2d at 1255. Here, Neptune presented no evidence or even argument that
`
`Beaudoin I results in compositions containing phospholipid concentrations outside
`
`the ranges claimed by claims 2 and 25. Thus, the Board should have found that
`
`Beaudoin I anticipates those claims.
`
`The Board has previously granted requests for rehearing of a decision not to
`
`institute an inter partes review on select grounds where it committed legal error in
`
`declining to review those grounds. In this case, the Board decision rests on two
`
`legal errors. For at least these reasons, the Board should institute a review of
`
`claims 2 and 25 as anticipated by Beaudoin I.
`
`II.
`
`STANDARD OF REVIEW
`
`Under 37 C.F.R. § 42.71(d), “[a] party . . . may file a request for rehearing[,]
`
`. . . specifically identify[ing] all matters the party believes the Board
`
`misapprehended or overlooked, and the place where each matter was previously
`
`addressed . . . .” On rehearing, the Board reviews a previous decision “for an
`
`abuse of discretion.” 37 C.F.R. § 42.71(c). “An abuse of discretion may be
`
`established by showing that the [Board] made a clear error of judgment in
`
`
`
`3
`
`
`
`
`
`weighing relevant factors or exercised its discretion based upon an error of law or
`
`clearly erroneous factual findings.” Novo Nordisk of N. Am., Inc. v. Genentech,
`
`Inc., 77 F.3d 1364, 1367 (Fed. Cir. 1996) (citation omitted).
`
`The Board previously has granted a request for rehearing because its refusal
`
`to institute review on anticipation grounds was legally erroneous in light of
`
`existing precedent. For example, in Illumina, Inc. v. Trustees of Columbia
`
`University, the Board originally declined to institute review for anticipation
`
`because the Board did not believe that a second reference was “incorporated by
`
`reference” in the primary reference. IPR2013-00006, slip op. at 2-5 (Patent Tr. &
`
`App. Bd. May 10, 2013). On rehearing, the Board “agree[d] … that [it] erred in
`
`not instituting” for anticipation in light of Federal Circuit precedent. Id. at 3-5; see
`
`also Illumina, Inc. v. Trustees of Columbia Univ., IPR2013-00011, slip op. at 3-5
`
`(Patent Tr. & App. Bd. May 10, 2013).
`
`III. ARGUMENT
`Beaudoin I anticipates claims 2 and 25. The Board’s determination to the
`
`contrary was based on two legal errors: (1) despite Beaudoin I’s express disclosure
`
`of phospholipid concentrations in the claimed range, the Board failed to follow the
`
`Federal Circuit’s controlling precedent in ClearValue, Inc. v. Pearl River
`
`Polymers, Inc., 668 F.3d 1340 (Fed. Cir. 2012), and instead applied the standard
`
`for inherent anticipation; and (2) the Board failed to follow controlling precedent,
`
`
`
`4
`
`
`
`
`
`including Best, 562 F.2d at 1255, and its progeny, which provides that once there is
`
`a prima facie case of anticipation based on identity between the prior art and
`
`patented products and processes, the burden shifts to the patentee to demonstrate
`
`some difference, which Neptune did not do.
`
`Viewed under the correct legal framework, Beaudoin I anticipates claims 2
`
`and 25, or at minimum, establishes “a reasonable likelihood that . . . the claims . . .
`
`[are] unpatentable.” See 37 C.F.R. § 42.108. Aker’s motion for rehearing should
`
`be granted and the Board should institute review of claims 2 and 25 based on
`
`anticipation (or obviousness) by Beaudoin I.
`
`A. The Board Applied The Wrong Legal Standard In Evaluating
`Beaudoin I’s Express Disclosure
`
`Under 35 U.S.C. § 102(b), a reference anticipates a patent claim if it
`
`“describe[s] . . . each and every claim limitation and enable[s] one of skill in the art
`
`to practice an embodiment of the claimed invention without undue
`
`experimentation.” ClearValue, 668 F.3d at 1345 (citation and internal quotation
`
`marks omitted). Anticipation may be express or inherent. Inherent anticipation
`
`applies only where “a claim limitation . . . is not expressly disclosed . . . .” See In
`
`re Montgomery, 677 F.3d 1375, 1379-80 (Fed. Cir. 2012) (citation and internal
`
`quotation marks omitted). In reaching its decision not to review claims 2 and 25
`
`for anticipation by Beaudoin I, the Board overlooked that Beaudoin I expressly
`
`
`
`5
`
`
`
`
`
`discloses the claimed phospholipid concentration and, thus, the standard for
`
`inherent anticipation is inapplicable.
`
`As Aker pointed out in its Petition, Paper 4 at 20, Beaudoin I expressly
`
`discloses phospholipid concentrations within the ranges claimed by claims 2 and
`
`25. Just as the Board understood “about 40% w/w, wherein about represents ±
`
`10%” in claims 2 and 25 to denote a range of phospholipid concentrations, Paper
`
`22 at 17 (“[A] range defined as about 40% w/w, wherein about represents ± 10%,
`
`i.e., from 30% to 50% . . . .”), so too does Beaudoin I’s recitation of “54.1% ±
`
`6.1%” in Table 14 disclose a range of phospholipid concentrations, i.e. 48-60.2%.
`
`Indeed, the Board acknowledged that “54.1% ± 6.1%” discloses a range of
`
`phospholipid concentrations. Id. (referring to “the range disclosed by Beaudoin
`
`I”); Ex. 1002 at Table 14, p. 23.2
`
`
`2 The Board’s recognition that Beaudoin I discloses a range of phospholipid
`
`concentrations is consistent with prior PTO decisions. See, e.g., In re Nestec,
`
`Ltd., No. 2010-001685, 2010 WL 1003908, at *12 (Bd. Pat. App. & Interf. Mar.
`
`17, 2010) (finding claims invalid where “[a]ppellant has not established that the
`
`differences between [prior art silica] and [claimed] silica are not within the
`
`margin of error of the tests”); In re Brossi, No. 95-3117, 1995 WL 1692976, at
`
`*2 (Bd. Pat. App. & Interf. Jan. 1, 1995) (finding claims invalid where “given
`
`
`
`6
`
`
`
`
`
`Because Beaudoin I expressly discloses a range of phospholipid
`
`concentrations that overlaps with the range claimed in claims 2 and 25, the Federal
`
`Circuit’s decision in ClearValue controls. In ClearValue, the patent at issue
`
`claimed a range of 50 ppm or less and the prior art disclosed a range of 150 ppm
`
`or less. Id. at 1344. The Federal Circuit determined that the claimed range in
`
`ClearValue was disclosed by the prior art because the patentee failed to show that
`
`the claimed range was “critical or that the claimed method works differently at
`
`different points within the prior art range of 150 ppm or less.” Id. at 1345. The
`
`holding in ClearValue is equally applicable where the prior art range overlaps, but
`
`does not fully encompass, the claimed range. For example, in In re Burgher, the
`
`Board of Patent Appeals and Interferences (“BPAI”) confirmed that claims were
`
`anticipated because the applicants did “not point out why the overlapping range
`
`disclosed by [the prior art] would not anticipate the range . . . required by claim 1.”
`
`No. 2008-5439, 2009 WL 45257 (Bd. Pat. App. & Interf. Jan. 6, 2009).
`
`Here, as in ClearValue and Burgher, the prior art Beaudoin I reference
`
`discloses a range of phospholipid concentrations that overlaps with the claimed
`
`range. Indeed, the range Beaudoin I discloses is much narrower than the range
`
`
`the margin of error, the BChE inhibition of [the claimed] compound 11 is
`
`within the range of [the prior art]”).
`
`
`
`7
`
`
`
`
`
`disclosed by the prior art in ClearValue or that is claimed in claims 2 and 25. Also
`
`like in ClearValue, Neptune has identified no criticality of its claimed range of
`
`phospholipid concentrations, or any way that range distinguishes the claims from
`
`Beaudon I. See ClearValue, 668 F.3d at 1345. Nothing in Neptune’s preliminary
`
`response, Paper 16, indicates that the range in claims 2 and 25 is critical.
`
`Neptune’s only arguments against anticipation by Beaudoin I were (1) that the
`
`Claimed Phospholipids3 were not inherent in Beaudoin I; and (2) that the Beaudoin
`
`I extract was not suitable for human consumption. Paper 16 at 8-20. Neptune did
`
`not even attempt to argue that the phospholipid concentration limitations of claims
`
`2 and 25 distinguish those claims from Beaudoin I.
`
`The ’351 patent specification likewise does not identify anything critical or
`
`distinguishing about the claimed phospholipid concentrations. To the contrary, the
`
`specification teaches that higher phospholipid concentrations like those in the
`
`range disclosed by Beaudoin I are preferred:
`
` “Phospholipids are generally present in the extract in an amount of
`at least 40% w/w, preferably at least 45% w/w[, and m]ore
`preferably, . . . from about 45-60% w/w. Ex. 1001 at 16, col.15
`ll.43-46 (emphasis added).
`
`
`3 “Claimed Phospholipids” refers to one or more of the phospholipids defined by
`
`the general formula of claim 1.
`
`
`
`8
`
`
`
`
`
` In Table 5, entitled “Lipid composition, vitamins A and E,
`pigments and flavonoids of the extract,” phospholipids are listed as
`≥ 40.00 g/100g sample. Id. at 17, col.17:52-col.18 l.7
`
` “Phospholipid market value is directly analogous to the purity
`achieved for the final product.” Id. at 18, col.19 ll.33-34.
`
`Notably, the patent’s “preferred” range of phospholipids—45-60%—is nearly
`
`identical to the range of phospholipids in Beaudoin I—48-60.2%. Compare Ex.
`
`1001 at 16 col.15 ll.43-46 with Paper 22 at 17; Paper 6 at 20; Ex. 1002, Table 14,
`
`p. 23. Because there has been no assertion, by Neptune or otherwise, that the range
`
`of phospholipids in claims 2 and 25 is critical or demonstrates a difference with
`
`Beaudoin I, the Board should have followed ClearValue and concluded that the
`
`range disclosed in Beaudoin I anticipates claims 2 and 25. 668 F.3d 1340, 1345.
`
`Even if the Board somehow did not view Beaudoin I’s range of phospholipids as
`
`anticipatory, it should have found the existence of this overlapping range to
`
`establish prima facie obviousness. In re Malagari, 499 F.2d 1297, 1303 (C.C.P.A.
`
`1974) (“There is no question that the claimed invention is rendered prima facie
`
`obvious [because] . . . the claimed range of carbon in the steel used as a starting
`
`material touches that in the ‘typical preferred range’ of the reference.”); see also
`
`Haynes Int’l, Inc. v. Jessop Steel Co., 8 F.3d 1573, 1577 n.3 (Fed. Cir. 1993),
`
`clarified on other grounds, 15 F.3d 1076 (Fed. Cir. 1994) (“[W]hen the difference
`
`between the claimed invention and the prior art is the range or value of a particular
`
`
`
`9
`
`
`
`
`
`variable, then a prima facie rejection is properly established when the difference in
`
`range or value is minor.”).
`
`
`
`Instead of following ClearValue, the Board declined to review claims 2 and
`
`25 for anticipation over Beaudoin I because, “[w]hile it is possible that 54.1 ±
`
`6.1% included 48% to 50%, which would have fallen within the recited range,” the
`
`Board was “not persuaded that the amount disclosed in Table 14 of Beaudoin I
`
`necessarily included such an amount.” Paper 22 at 17. As support for its decision,
`
`the Board cited an inherent anticipation case, MEHL/Biophile Int’l Corp. v.
`
`Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999), for the proposition that
`
`“[i]nherency . . . may not be established by probabilities or possibilities.” Paper 22
`
`at 17 (internal quotation marks omitted). There is no reason why the Board should
`
`have applied an inherent anticipation standard, however, where Beaudoin expressly
`
`discloses phospholipid concentrations within the claimed ranges. Board’s analysis
`
`reflects a misunderstanding of the law and constitutes an abuse of discretion.
`
`B.
`
`The Board’s Decision Not To Institute Inter Partes Review Of
`Claims 2 And 25 Based On Anticipation By Beaudoin I
`Contravenes In re Best And Its Progeny
`
`The Board’s determination that Beaudoin I does not inherently anticipate
`
`claims 2 and 25 also constitutes legal error and therefore, an abuse of discretion.
`
`As explained in Aker’s petition, the extraction processes in Beaudoin I and the
`
`’351 patent are identical or substantially identical. Paper 4 at 12; compare Ex.
`
`
`
`10
`
`
`
`
`
`1002, p. 5, l.21-p.6, l.20 with Ex. 1001, col.18, l.53-col.19, l.9. The Board
`
`acknowledged this, adopting Aker’s arguments on Page 12 of Aker’s petition that
`
`“the processes described in the ’351 patent and . . . the prior art are virtually
`
`indistinguishable,” and as a result so, too, “would be the resulting extracts.” Paper
`
`4 at 12; Paper 22 at 12-13 (explaining that “the evidence presented by Aker tends
`
`to demonstrate that the E. pacifica extract disclosed in Beaudoin I comprised at
`
`least one [Claimed Phospholipid] under the principles of inherency as explained by
`
`Aker. Pet. 12” (emphasis added)) The Board also rejected Neptune’s attempt to
`
`differentiate the processes based on the purported heating step of Beaudoin I and
`
`the “suitable for human consumption” limitation as “unpersuasive.” See Paper 22
`
`at 12-13.
`
`Under the controlling precedent of Best and its progeny, when the claimed
`
`and prior art products “are produced by identical or substantially identical
`
`processes,” it is the patentee’s burden “to prove that the prior art products do not
`
`necessarily or inherently possess the characteristics of his claimed product.” E.g.,
`
`Best, 562 F.2d at 1255; see also In re Spada, 911 F.3d 705, 708 (Fed. Cir. 1990)
`
`(explaining that where the PTO “show[ed] sound basis for believing that the
`
`products of the applicant and prior art are the same, the applicant has the burden of
`
`proving they are not”). If the patentee does not meet this burden, the claimed
`
`products should be deemed anticipated. Id. For example, in Spada, the BPAI
`
`
`
`11
`
`
`
`
`
`rejected claims because the claimed compositions “appear[ed] to be identical” to
`
`those in the prior art. 911 F.2d at 708. The Federal Circuit confirmed that “it was
`
`reasonable . . . to infer that the polymerization by both [the prior art] and Spada of
`
`identical monomers, employing the same or similar polymerization techniques,
`
`would produce polymers having the identical composition.” Id. The Court further
`
`explained that Spada did not rebut this prima facie case of unpatentability because
`
`he failed to “provide some scientific explanation for the asserted differences
`
`between the properties of his compositions and those described by [the] prior art.”
`
`Id. at 709.
`
`Similarly, in In re Oyama, the BPAI determined that “[b]ecause the claimed
`
`product and the prior art are made from the same starting material . . . and are
`
`produced by a substantially similar process, the Examiner had a sufficient basis to
`
`believe that the prior art product would reasonably appear to have the claimed
`
`characteristics.” No. 2008-3682, 2008 WL 5264249, at *10 (Bd. Pat. App. &
`
`Interf. Dec. 16, 2008) (citations omitted). The applicant’s arguments to the
`
`contrary were insufficient to “show [that] the prior art process will not inherently
`
`result in the claimed [composition],” and the BPAI affirmed the anticipation
`
`rejection. Id. at *10-11.
`
` Here, Neptune “offered no such showing” that the processes in Beaudoin I
`
`and the ’351 patent resulted in products with different phospholipid concentrations.
`
`
`
`12
`
`
`
`
`
`See Spada, 911 F.2d at 708-09. As explained above, the Board rejected Neptune’s
`
`only arguments that Beaudoin I’s process was different than that which was used to
`
`produce the claimed inventions. See Paper 22 at 12-13. In addition, Neptune
`
`offered no argument distinguishing any of its dependent claims from Beaudoin I
`
`(or any other prior art reference). Accordingly and for this independent reason, the
`
`Board abused its discretion in declining to institute a review of claims 2 and 25 for
`
`anticipation by Beaudoin I.
`
`
`
`
`
`
`
`13
`
`
`
`
`
`
`
`IV. CONCLUSION
`For the foregoing reasons, Aker respectfully requests that the Board
`
`authorize a review of claims 2 and 25 as anticipated, or at minimum rendered
`
`prima facie obvious, by Beaudoin I.
`
`
`Date: April 7, 2014
`
`
`
`
`Respectfully submitted,
`
`By: ___/J. Mitchell Jones/_____________
`J. Mitchell Jones, Ph.D.
`jmjones@casimirjones.com
`Reg. No. 44,174
`CASIMIR JONES SC
`2275 Deming Way, St. 310
`Middleton, WI 53562
`Tel: (608) 662-1277
`Fax: (608) 662-1276
`Lead Counsel for Petitioner
`
`
`Amanda J. Hollis
`amanda.hollis@kirkland.com
`KIRKLAND & ELLIS LLP
`300 N. LaSalle St.
`Chicago, IL 60654
`Tel: (312) 862-2011
`Fax: (312) 862-2200
`Back-up Counsel for Petitioner
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`14
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(b) that a
`
`complete copy of this Motion For Rehearing is being served electronically via e-
`
`mail (as consented to by the Patent Owner), on April 7, 2014, the same day as the
`
`filing of the above-identified documents in the United States Patent and Trademark
`
`Office (USPTO), upon:
`
`
`Stephen L. Altieri, Ph.D.
`saltieri@cooley.com
`zpatdcdocketing@cooley.com
`Cooley LLP
`Attn: Patent Group
`1299 Pennsylvania Ave., NW, Ste.
`700
`Washington, D.C.
`Tel: (617) 937-2371
`Fax: (202) 842-7899
`Lead Counsel for Patent Owner
`
`
`
`J. Dearn Farmer, Ph.D.
`dfarmer@cooley.com
`zpatdcdocketing@cooley.com
`Cooley LLP
`Attn: Patent Group
`1299 Pennsylvania Ave., NW, Ste. 700
`Washington, D.C.
`Tel: (617) 937-2370
`Fax: (202) 842-7899
`Back-up Counsel for Patent Owner
`
`
`
`
`__/J. Mitchell Jones/_______
`J. Mitchell Jones, Ph.D.
`
`
`
`
`
`
`
`
`
`
`15
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