Steuben Foods, Inc. v. Oystar USA, Inc.
Filing
355
DECISION AND ORDER denying (292) Motion for Summary Judgment and declining to adopt (320) Report and Recommendations in case 1:10-cv-00780-EAW-JJM; denying (399) Motion for Summary Judgment and declining to adopt (424) Report and Recommendations in case 1:10-cv-00781-EAW-JJM; denying (506) Motion for Summary Judgment and declining to adopt (536) Report and Recommendations in case 1:12-cv-00904-EAW-JJM; denying (335) Motion for Summary Judgment and declining to adopt (365) Report and Recomm endations in case 1:13-cv-00892-EAW-JJM; denying (245) Motion for Summary Judgment and declining to adopt (272) Report and Recommendations in case 1:13-cv-01118-EAW-JJM. Signed by Hon. Elizabeth A. Wolford on 09/16/2019. Associated Cases: 1:10-cv-00780-EAW-JJM, 1:10-cv-00781-EAW-JJM, 1:12-cv-00904-EAW-JJM, 1:13-cv-00892-EAW-JJM, 1:13-cv-01118-EAW-JJM(CDH)
UNITED STATES DISTRICT COURT
SEP 1 6 2019
WESTERN DISTRICT OF NEW YORK
DISTRISJSTEUBEN FOODS,INC.,
Plaintiff,
I:I0-CV-00780EAW
V.
OYSTAR USA,INC., et al,
Defendants.
STEUBEN FOODS,INC.,
Plaintiff,
I:I0-CV-0078I LAW
V.
SHIBUYA HOPPMANN CORP., SHIBUYA
KOGYO CO. LTD, and HP HOOD LLC,
Defendants.
STEUBEN FOODS,INC.,
Plaintiff,
I:I2-CV-00904 LAW
V.
GEA PROCESS ENGINEERING,INC., and GEA
PROCOMAC S.P.A.,
Defendants.
-I-
STEUBEN FOODS,INC.
Plaintiff,
1:13-CV-00892EAW
V.
NESTLE, U.S.A.,
Defendant.
STEUBEN FOODS,INC.,
Plaintiff,
1:13-CV-01118EAW
V.
JASPER PRODUCTS,LLC,
Defendant.
INTRODUCTION
In the above-captioned actions, which have been consolidated for purposes of
discovery and claim construction, plaintiff Steuben Foods, Inc. ("Plaintiff) has sued the
defendants for patent infringement under 35 U.S.C. §§ 100 e? seq. Each matter has been
referred to United States Magistrate Judge Jeremiah J. McCarthy for hearing and
disposition of all non-dispositive motions or applications, supervision of discovery, and to
hear and report upon dispositive motions for consideration by the district judge. (Civil
ActionNo. 1:10-cv-00780(the "Oystar Action"),Dkt. 100; Civil Action No l:10-cv-00781
-2-
(the "Shibuya Action"), Dkt. 112; Civil Action No. 12-cv-00904(the"GEA Action"), Dkt.
82; Civil Action No. l:13-cv-00892 (the "Nestle Action"), Dkt. 18; Civil Action No. 13cv-01118(the "Jasper Action"), Dkt. 18).
On June 1, 2018, defendants in the Oystar Action, the GEA Action, the Nestle
Action, and the Jasper Action jointly moved for partial summary judgment pursuant to
Federal Rule of Civil Procedure 56. (Oystar Action, Dkt. 292; GEA Action, Dkt. 506;
Nestle Action, Dkt. 335; Jasper Action, Dkt. 245). That same day, defendants in the
Shibuya Action filed their own motion for summaryjudgment. (Shibuya Action,Dkt. 399).
On October 1, 2018, Judge McCarthy issued a Report and Recommendation (Oystar
Action, Dkt. 320; Shibuya Action, Dkt. 424; GEA Action, Dkt. 536; Nestle Action, Dkt.
365; Jasper Action, Dkt. 272)(the "R&R")recommending that the pending motions for
summary judgment be "granted to the extent of invalidating claim 40 of [United States
Patent No.6,536,188] and limiting the sterilant in the other 'aseptically disinfecting' claims
to hydrogen peroxide, but otherwise be denied." (R&R at 12-13)^
Plaintiff filed objections to the R&R in each of the actions. (Oystar Action, Dkt.
329; Shibuya Action, Dkt. 434; GEA Action, Dkt. 548; Nestle Action, Dkt. 365; Jasper
Action, Dkt. 272)(hereinafter "Plaintiffs Objections"). Objections have also been filed
by defendants HAMBA Filltec GmbH & Co.KG, OYSTAR Group, OYSTAR Hamba,
'
Consistent with Judge McCarthy's practice in the R&R, and for the avoidance of
confusion given the multiple dockets at issue, page references in this Decision and Order
are to those found on the original documents, and not to those generated by the Court's
Case Management/Electronic Case Files system.
OYSTAR North America-Edison, Inc., and Oystar USA, Inc. (collectively the "Oystar
Defendants")(Oystar Action, Dkt. 327), defendant Kan-Pak, LLC ("Kan-Pak")(Oystar
Action, Dkt. 328), and defendants Shibuya Hoppmann Corporation, Shibuya Kogyo Co.,
Ltd., and HP Hood LLC (collectively the "Shibuya/Hood Defendants")(Shibuya Action,
Dkt. 435).
For the reasons set forth below, the Court declines to adopt the R&R, and instead
finds that there are outstanding issues of material fact as to whether claim 40 of United
States Patent No. 6,536,188 is invalid for lack of a written description. The Court further
finds that, because the R&R's claim construction analysis is inextricably intertwined with
the analysis of claim 40's validity, construction of the term "aseptically disinfecting," as
used in the patents in suit, is not currently ripe for the undersigned's review. The Court
accordingly denies the pending motions for summary judgment without prejudice to
renewal on a more fully developed record.
FACTUAL AND PROCEDURAL BACKGROUND
Additional factual and procedural background related to the instant actions is set
forth in the R&R, familiarity with which is assumed for purposes of this Decision and
Order. The Court has summarized the salient information here for ease of reference.
Plaintiff is the owner of several patents related to methods for aseptically bottling
and packaging sterilized food products, including United States Patent No.6,945,013 (the
"'013 Patent"), United States Patent No. 6,702,985 (the '"985 Patent"), United States
Patent No. 6,481,468 (the '"468 Patent"), and United States Patent No. 6,536,188 (the
"'188 Patent"). (See Oystar Action, Dkt. 238 at 1). Numerous claims in the patents in suit
use the term "aseptically disinfecting," the construction of which relates to the conclusions
set out in the R&R.(R&R at 1)
("This Report and Recommendation addresses the question
of whether the phrase 'aseptically disinfecting,' contained in several claims ofthe patents
in suit, can be validly construed and/or applied to cover the use of a sterilant known as
oxonia[.]").
The '188 Patent(among others) provides background information that helps put in
context some ofthe issues in this litigation. As explained in the '188 Patent,"[pjackaged
food products can generally be categorized as high acid products . . . or low acid
products[.]" ('188 Patent col. 1,11.22-23). Unlike high acid products that naturally inhibit
bacterial growth, low acid products must use "more stringent packaging techniques" to
extend their shelf lives, and "often require[] refrigeration of the product at the point of
sale." (Id. col. 1,11. 23-28). Aseptic packaging is a means of significantly extending the
shelflife oflow acid products and involves the use ofpresterilized containers in a sterilized
environment. (Id. col. 1, 11. 38-45). The FDA regulates aseptic packaging within the
United States and requires the use of an FDA-approved sterilant and satisfaction of various
other quality control measures. (See id. col. 1,1. 46-54).
The patents in suit define the term "aseptic" as "the United States 'FDA level of
aseptic.'" Nestle USA,Inc. v. Steuben Foods, Inc., 686 F. App'x 917,919(Fed. Cir. 2017)
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(quoting the '013 Patent col. 1 1. 67-coI 2. 1. 2, col. 4 11. 28-29). The Federal Circuit has
construed "FDA level of aseptic" as defined by "FDA regulations related to aseptic
packaging." Id. One such regulation is 21 C.F.R. § 113, which states in relevant part that
"[ajseptic processing and packaging means the filling of a commercially sterilized cooled
product into presterilized containers, followed by aseptic hermetical sealing, with a
presterilized closure, in an atmosphere free of microorganisms," and that "commercial
sterility" is achieved by the application of"heat, chemical sterilant(s), or other appropriate
treatment." 21 C.F.R. § 113(a),(e)(2). At the time the patents in suit were filed, the only
FDA approved chemical sterilant was hydrogen peroxide. Oxonia, which is a combination
of hydrogen peroxide and peroxyacetic acid, and which is used as a sterilant by certain of
the defendants in these actions, was not FDA-approved at the relevant time. {See R&R at
1-3). Nevertheless, the specifications of several of the patents in suit state that either
hydrogen peroxide or oxonia may be used as a sterilant. {See id. at 4). Moreover, claim
40 of the '188 Patent specifically describes a method of aseptic packaging wherein the
sterilant is oxonia. ('188 Patent at col. 6,11. 14-15, 25-26).
At his deposition, Thomas D. Taggart ("Taggart"), the listed inventor for each of
the patents in suit, was asked whether the term "aseptically disinfecting" requires the use
of an FDA-approved sterilant and he responded that it did. {See GEA Action, Dkt. 427-11
(hereinafter the "Taggart EBT") at 385:25-386:7 ("Q: In your patents you use the term
'aseptically disinfecting'.... As you understand the term 'aseptic disinfecting,' does that
require the use ofan FDA-approved sterilant?... A: Yes. That's what I think it's supposed
to mean."). As Judge McCarthy noted in the R&R,the relevant patent specifications also
indicate that "[f]or the aseptic packaging of food products, an aseptic filler must ... use
an FDA(Food and Drug Administration)approved sterilant." {Id. at 3(quoting '013 patent
col. 1,11.48-50;'188 patent col. 1,11. 46-48)).
Taggart further testified at his deposition that prior to filing the relevant patent
applications, he had never used oxonia as a sterilant, nor did he have any knowledge
regarding oxonia's effectiveness as a sterilant. {See Taggart EBT at 232:10-233:3)^. For
example, when asked whether peroxyacetic acid could achieve a "6-log reduction in spore
organisms,"^ Taggart replied that he "would think that it could" but that this was "just an
opinion." {Id. at 173:23-174:10). Taggart further stated that he had never seen oxonia's
components used "in a vaporized form as a container sterilant" and that he did not know
whether oxonia's components could "be applied in a vapor form and receive approval from
the FDA." {Id. at 172:9-12, 173:5-8).
^
Throughout his deposition testimony, Taggart frequently referred to "peracetic
acid." As Judge McCarthy noted in the R&R,the parties have agreed that "peracetic acid"
is synonymous with "peroxyacetic acid," which is one ofthe components of oxonia.(R&R
at 4 n.6).
^
Taggart had testified earlier that at the time the patents in suit were written, the FDA
required a 6-log reduction in spore organisms to qualify as aseptic sterilization. (Taggart
EBT at 28:7-15).
Judge McCarthy held a Markman''hearing on January 31,2018,in order to consider
the construction ofthe term "aseptically disinfecting" as used in the patents in suit. {See
Oystar Action, Dkt. 273). Thereafter, on February 13, 2018, Judge McCarthy issued a
notice pursuant to Federal Rule of Civil Procedure 56(f)(3)^ in which he indicated that
although he and the parties "had planned to defer consideration ofvalidity issues until after
claim construction," it "appear[ed] to [him] that the phrase 'aseptically disinfecting' ...
cannot be properly construed without also considering certain validity issues, namely
enablement and utility." (Oystar Action,Dkt. 275; Shibuya Action,Dkt.376; GEA Action,
Dkt. 486; Nestle Action, Dkt. 318; Jasper Action, Dkt. 228) (the "First Rule 56(f)(3)
Notice"). Judge McCarthy further gave the parties notice of facts that appeared to be
undisputed, and set forth legal reasoning as to why, in his view, these undisputed facts
rendered claim 40 ofthe'188 Patent invalid for lack ofenablement and utility and required
that the phrase "aseptically disinfecting" in all other relevant claims of the patents in suit
be limited to the use of hydrogen peroxide. (First Rule 56(f)(3) Notice at 2-6). Judge
McCarthy ordered the parties to, on or before March 6, 2018,"show cause why summary
judgment should not be granted:(1) declaring claim 40 of the '188 Patent to be invalid,
and (2) limiting the meaning of the phrase 'aseptically disinfecting' as used in the other
patent claims to those methods using hydrogen peroxide as the sterilant." {Id. at 6). Judge
Markman v. Westview Instruments, Inc., 517 U.S. 370, 384(1996).
^
Pursuant to Rule 56(f)(3), the Court may "consider summary judgment on its own
after identifying for the parties material facts that may not be genuinely in dispute."
-8-
McCarthy subsequently moved the response deadline to March 20,2018. (See, e.g., Oystar
Action, Dkt. 276).
The parties filed responses to the First Rule 56(f)(3) Notice on March 20, 2018.
(Oystar Action, Dkt. 278; Oystar Action, Dkt. 279; Shibuya Action, Dkt. 382; Shibuya
Action, Dkt. 383; GEA Action, Dkt. 490; GEA Action, Dkt. 491; GEA Action, Dkt. 492;
Nestle Action, Dkt. 321; Nestle Action, Dkt. 322; Jasper Action, Dkt. 231; Jasper Action,
Dkt. 232). On April 3, 2018, Judge McCarthy issued a second Rule 56(f)(3) notice.
(Oystar Action,Dkt. 283; Shibuya Action, Dkt. 388; GEA Action, Dkt.497;Nestle Action,
Dkt. 326; Jasper Action, Dkt. 236)(the "Second Rule 56(f)(3) Notice"). In the Second
Rule 56(f)(3) Notice, Judge McCarthy explained that although the First Rule 56(f)(3)
Notice had focused on enablement and utility, "a separate question is whether Taggart
actually invented a system utilizing oxonia - that is, whether he both conceived the
invention and reduced it to practice." (Id. at 1). Judge McCarthy explained that he had
"tentatively conclude[d] that the record clearly and convincingly demonstrates" that
Taggart had neither conceived nor reduced to practice the use of oxonia as a sterilant, that
claim 40 ofthe '188 Patent is invalid, and that"even ifthe phrase 'aseptically disinfecting'
can be construed to include oxonia as the sterilant, the patents cannot validly be applied to
its use." (Id. at 5).
On April 20, 2018, Judge McCarthy entered a Decision and Order setting forth his
preliminary construction of the term "aseptically disinfecting." (Oystar Action, Dkt. 287;
-9-
Shibuya Action, Dkt. 392; GEA Action, Dkt. 501; Nestle Action, Dkt. 330; Jasper Action,
Dkt. 240) (the "Claim Construction D&O"). In the Claim Construction D&O, Judge
McCarthy concluded as follows: (1) "aseptically disinfecting" cannot be construed to
preclude the use ofoxonia; and(2)the term "aseptically disinfecting" is properly construed
"to mean the use of a sterilant capable of being approved by the FDA, as of the effective
patent filing date, to satisfy the 'FDA level of aseptic' defined by the Federal Circuit in
Nestle USA. Inc. v. Steuben Foods. Inc.. 686 Fed. App'x 917, 918-19 (Fed. Cir. 2017)."
{Id. at 2-5). Judge McCarthy further explained that, based on the record before him, he did
not believe that the patents in suit contained a valid written description of a packaging
method using oxonia as a sterilant. {Id. at 6-11). The Claim Construction D&O indicated
that it was not a final document and that Judge McCarthy's construction of the term
"aseptically disinfecting" would ultimately be incorporated into a report and
recommendation. {Id. at 1 n.2).
On April 30, 2018, Judge McCarthy ordered Defendants to file any motions "for
summary judgment based upon invalidity for insufficient written description" by no later
than June 1,2018. (Oystar Action, Dkt. 290; Shibuya Action, Dkt. 395; GEA Action, Dkt.
504; Nestle Action, Dkt. 333; Jasper Action, Dkt. 243). Defendants filed their partial
summary judgment motions on June 1, 2018. (Oystar Action, Dkt. 292; Shibuya Action,
Dkt. 399; GEA Action, Dkt. 506; Nestle Action, Dkt. 335; Jasper Action, Dkt. 245). On
July 10, 2018, Plaintiff filed a motion pursuant to Federal Rule of Civil Procedure 56(d)
-10-
for discovery related to Defendants' pending partial summary judgment motions. (Oystar
Action, Dkt. 299; Shibuya Action, Dkt. 404; GEA Action, Dkt. 513; Nestle Action, Dkt.
343; Jasper Action, Dkt. 251). Judge McCarthy issued a Decision and Order denying the
request for discovery on July 11, 2018. (Oystar Action, Dkt. 302; Shibuya Action, Dkt.
407; GEA Action, Dkt. 516; Nestle Action, Dkt. 346; Jasper Action, Dkt. 254).
That same day. Judge McCarthy issued a third Rule 56(f)(3)notice. (Oystar Action,
Dkt. 303; Shibuya Action, Dkt. 408; GEA Action, Dkt. 517; Nestle Action, Dkt. 347;
Jasper Action, Dkt. 255)(the "Third Rule 56(f)(3) Notice"). In the Third Rule 56(f)(3)
Notice, Judge McCarthy explained that his "sole focus" in considering whether partial
summary judgment in Defendants' favor was warranted would be "on whether Thomas
Taggart invented a method for aseptically disinfecting containers using oxonia as a
sterilant." {Id. at 1). Judge McCarthy incorporated by reference the Second Rule 56(f)(3)
Notice, the Claim Construction D&O, and Defendants' motions for partial summary
judgment"to the extent that those motions relate to invention by Mr. Taggart," and ordered
Plaintiff to "show cause why summary judgment of invalidity should not be entered[.]"
{Id. at 2).
Plaintiff filed its response to the Third Rule 56(f)(3) notice on August 24, 2018
(Oystar Action,Dkt. 307; Shibuya Action,Dkt.412; GEA Action,Dkt. 521;Nestle Action,
Dkt. 351; Jasper Action, Dkt. 259), and Defendants filed replies on September 14, 2018
(Oystar Action, Dkt.312; Oystar Action, Dkt.313; Shibuya Action,Dkt.417;GEA Action,
-11-
Dkt. 529; Nestle Action, Dkt. 358; Jasper Action, Dkt. 264; Jasper Action, Dkt. 265).
Judge McCarthy held oral argument on September 19, 2018. (See, e.g., Oystar Action,
Dkt. 314).
Judge McCarthy issued the R&R on October 1, 2018. (Oystar Action, Dkt. 320;
Shibuya Action, Dkt. 424; GEA Action, Dkt. 536; Nestle Action, Dkt. 365; Jasper Action,
Dkt. 272). The R&R reaches the following conclusions: (1) the phrase "aseptically
disinfecting ... cannot validly cover the use of oxonia as the sterilant";(2)as ofthe filing
date of the patents in suit, Taggart could not have satisfied the FDA's requirements for
approval of oxonia as a sterilant; (3) Taggart did not adequately describe the invention
defined in claim 40 ofthe '188 Patent^; and(4)"those aseptically disinfecting claims which
do not identify the sterilant should be construed to preserve their validity by limiting the
sterilant to hydrogen peroxide, the only sterilant which has been properly described." (Id.
at 2-12). Based on these conclusions,the R&R recommends granting Defendants' motions
for partial summary judgment to the extent of finding claim 40 ofthe '188 Patent invalid
and limiting the term "aseptically disinfecting" to the use of hydrogen peroxide as a
sterilant in all remaining claims ofthe patents in suit. (Id. at 12-13).
Plaintiff, the Oystar Defendants, Kan-Pak, and the Shibuya/Hood Defendants filed
objections to the R&R on November 2, 2018. (Oystar Action, Dkt. 327; Oystar Action,
^
Claim 40 of the '188 Patent claims "[a] method for aseptically bottling aseptically
sterilized foodstuffs . . . wherein the sterilant is peroxyacetic acid and hydrogen
peroxide[.]" ('188 Patent at col. 6,11. 14-15, 25-26).
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Dkt. 328; Oystar Action, Dkt. 329; Shibuya Action, Dkt. 435; GEA Action, Dkt. 548;
Nestle Action, Dkt. 365; Jasper Action, Dkt. 272). Responses were filed on December 3,
2018(Oystar Action,Dkt. 330; Oystar Action, Dkt. 331; Oystar Action, Dkt. 332; Shibuya
Action, Dkt. 436; GEA Action, Dkt. 549; GEA Action, Dkt. 550; Nestle Action, Dkt. 376;
Nestle Action, Dkt. 377; Nestle Action, Dkt. 378; Jasper Action, Dkt. 280; Jasper Action,
Dkt. 281), and replies were filed on December 21, 2018 (Oystar Action, Dkt. 336; Oystar
Action, Dkt. 337; Shibuya Action, Dkt. 442; Shibuya Action, Dkt. 443; GEA Action, Dkt.
555; GEA Action, Dkt. 556; Nestle Action, Dkt. 383; Nestle Action, Dkt. 384; Jasper
Action, Dkt. 285; Jasper Action, Dkt. 286). With the Court's permission, sur-replies were
filed in the GEA and Nestle Actions on January 16, 2019. (GEA Action, Dkt. 559; Nestle
Action, Dkt. 388).
Oral argument on the pending objections was held on February 26, 2019. (See
Oystar Action, Dkt. 342). Post-argument, Plaintiff filed a motion seeking leave to file
supplemental briefing regarding the impact of a May 8, 2019, decision by the Patent Trial
and Appeal Board. (Dkt. 349). The Court granted Plaintiffs motion (Dkt. 350), and the
parties filed supplemental briefs on May 24, 2019. (See Oystar Action, Dkt. 352; Shibuya
Action, Dkt. 457; Shibuya Action, Dkt. 458; GEA Action, Dkt. 571; GEA Action, Dkt.
572; Nestle Action, Dkt. 402; Nestle Action, Dkt. 403; Jasper Action, Dkt. 296; Jasper
Action, Dkt. 297).
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DISCUSSION
I.
Standard of Review for Reports and Recommendations
Pursuant to 28 U.S.C. § 636(b)(1)(C), where a party makes specific objections to a
magistrate judge's report and recommendation, the district judge must "make a de novo
determination of those portions of the report or specified proposed findings or
recommendations to which objection is made." 28 U.S.C. § 636(b)(1)(C). "The Court
reviews unobjected-to findings for clear error." Am. Ins. Co. v. City ofJamestown, 914 F.
Supp. 2d 377, 384(W.D.N.Y. 2012). After conducting its review, the Court may "accept,
reject, or modify, in whole or in part, the findings or recommendations made by the
magistrate judge." 28 U.S.C. § 636(b)(1)(C).
II.
Legal Standard for Summary Judgment
Rule 56 of the Federal Rules of Civil Procedure provides that summary judgment
should be granted if the moving party establishes "that there is no genuine dispute as to
any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ.
P. 56(a). The Court should grant summary judgment if, after considering the evidence in
the light most favorable to the nonmoving party, the court finds that no rational jury could
find in favor of that party. Scott v. Harris, 550 U.S. 372, 380 (2007)(citing Matsushita
Elec. Indus. Co. v. Zenith Radio Corp.,475 U.S. 574, 586-87(1986)).
"The moving party bears the burden ofshowing the absence of a genuine dispute as
to any material fact. . . ." Crawford v. Franklin Credit Mgmt. Corp., 758 F.3d 473, 486
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(2d Cir. 2014). "Where the non-moving party will bear the burden of proof at trial, the
party moving for summary judgment may meet its burden by showing the evidentiary
materials of record, if reduced to admissible evidence, would be insufficient to carry the
non-movant's burden of proof at trial." Johnson v. Xerox Corp., 838 F. Supp. 2d 99, 103
(W.D.N.Y.2011)(citing Celotex Corp. v. Catrett,477 U.S. 317,322-23(1986)). Once the
moving party has met its burden,the opposing party "must do more than simply show that
there is some metaphysical doubt as to the material facts, and may not rely on conclusory
allegations or unsubstantiated speculation." Robinson v. Concentra Health Servs., Inc.,
781 F.3d 42, 44(2d Cir. 2015)(quoting Brown v. Eli Lilly & Co., 654 F.3d 347, 358(2d
Cir. 2011)). Specifically, the non-moving party "must come forward with specific
evidence demonstrating the existence of a genuine dispute of material fact." Brown, 654
F.3d at 358. Indeed, "the mere existence of some alleged factual dispute between the
parties will not defeat an otherwise properly supported motion for summary judgment; the
requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby,
Inc., All U.S. 242, 247-48(1986).
III.
Legal Standard for Claim Construction
The R&R in this matter involves claim construction issues. As the Supreme Court
has explained:
The[re] are two elements of a simple patent case, construing the patent and
determining whether infringement occurred. . . . The first is a question of
law, to be determined by the court, construing the letters-patent, and the
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description ofthe invention and specification ofclaim annexed to them. The
second is a question of fact, to be submitted to a jury.
Markman v. Westview Instruments, Inc., 517 U.S. 370, 384(1996)(quotation omitted).
In construing [patent] claims, the analytical focus must begin and remain
centered on the language ofthe claims themselves, for it is that language that
the patentee chose to use to particularly point[]out and distinctly claim[]
the subject matter which the patentee regards as his invention. The words
used in the claims are examined through the viewing glass ofa person skilled
in the art. In the absence of an express intent to impart a novel meaning to
the claim terms, the words are presumed to take on the ordinary and
customary meanings attributed to them by those of ordinary skill in the art.
Brookhill-Wilk 1, LLC. v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298 (Fed. Cir. 2003)
(quotation and citations omitted). "To ascertain the scope and meaning of the asserted
claims, [a court] look[s] to the words of the claims themselves, the specification, the
prosecution history, and any relevant extrinsic evidence." Ericsson, Inc. v. D-Link Sys.,
Inc., 773 F.3d 1201, 1217-18 (Fed. Cir. 2014). "Claim construction issues are often
dispositive ofthe parties' claims and defenses in a particular case," and the Court therefore
reviews a magistrate judge's claim construction determination de nova where, as here,
objections are made. Fisher-Price, Inc. v. Kids II, Inc., No. l:10-CV-00988 EAW,2015
WL 2401887, at *1 (W.D.N.Y. May 19, 2015).
IV.
Validity of Claim 40 of the '188 Patent
The primary issue considered by the R&R is whether claim 40 ofthe 188 Patent is
'
invalid for lack of written description. {See R&R at 7-11). This is also the subject matter
of the pending motions for summary judgment. {See Oystar Action, Dkt. 292; Shibuya
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Action, Dkt. 399). Moreover, and as discussed further below, the R&R's construction of
the term "asepticaily disinfecting" depends upon and is informed by Judge McCarthy's
assessment of claim 40's validity. As such,the Court considers the validity issue first.
Plaintiff makes the following objections to the R&R's conclusions regarding the
validity of claim 40 ofthe '188 Patent:(1)the R&R applied an improper legal standard in
determining whether the '188 Patent complied with the written description requirement of
35 U.S.C. § 112 and erroneously concluded that the'188 Patent failed to satisfy the written
description requirement; and (2)the R&R misapplied the standard for summary judgment
in that all reasonable inferences were not drawn in Plaintiffs favor. The Court has
considered these arguments de novo and finds, for the reasons set forth below, that, at this
stage ofthe proceedings, there are genuine issues of material fact as to whether claim '40
is invalid for a lack of written description. The Court accordingly declines to adopt the
R&R.
A.
Written Description Requirement
Pursuant to 35 U.S.C. § 112(a), a patent must have a specification that contains:
[A] written description of the invention, and of the manner and process of
making and using it, in such full, clear, concise, and exact terms as to enable
any person skilled in the art to which it pertains, or with which it is most
nearly connected,to make and use the same, and shall set forth the best mode
contemplated by the inventor or joint inventor of carrying out the invention.
Id. As the Federal Circuit has explained, § 112(a) contains three separate requirements
that are described "[i]n common parlance ... as the 'written description requirement,' the
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'enablement requirement,' and the 'best mode requirement,' respectively." Univ. of
Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916,921 (Fed. Cir. 2004). "Although there
is often significant overlap between the three requirements, they are nonetheless
independent of each other." Id. In particular, "the written description requirement retains
independent force, because 'requiring a written description of the invention plays a vital
role in curtailing claims that do not require undue experimentation to make and use, and
thus satisfy enablement, but that have not been invented, and thus cannot be described.'"
Petito V. Puritan's Pride, Inc., 35 F. Supp. 3d 494, 512 (S.D.N.Y. 2014)(quoting Ariad
Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010)). "The essence
ofthe written description requirement is that a patent applicant, as part ofthe bargain with
the public, must describe his or her invention so that the public will know what it is and
that he or she has truly made the claimed invention." AbbVie Deutschland GmbH & Co.,
KG V. Janssen Biotech, Inc., 759 F.3d 1285, 1298(Fed. Cir. 2014).
To satisfy the written description requirement, the specification must "clearly allow
persons of ordinary skill in the art to recognize that [the inventor] invented what is
claimed." Ariad, 598 F.3d at 1351(quotation omitted and alteration in original). Inherent
in the written description requirement is "the fundamental issue whether [the inventor]
actually invented the subject matter it claimed in the" contested patent. Univ. ofRochester,
358 F.3d at 930 n.lO. The written description requirement accordingly requires that the
specification "show that the inventor actually invented the invention claimed." Ariad, 598
-18-
F.3d at 1351. As the Federal Circuit has explained, "[r]equiring a written description of
the invention limits patent protection to those who actually perform the difficult work of
invention—^that is, conceive of and complete the final invention. The written description
requirement exists to ensure that inventors do not attempt to preempt the future before it
has arrived." Billups-Rothenberg, Inc. v. Associated Reg'I & Univ. Pathologists, Inc., 642
F.3d 1031, 1036(Fed. Cir. 2011)(intemal quotations and citations omitted). The written
description requirement, "does not demand either examples or an actual reduction to
practice," but does require a "constructive reduction to practice that in a definite way
identifies the claimed invention." Streck, Inc. v. Research & Diagnostic Sys., Inc., 665
F.3d 1269, 1285 (Fed. Cir. 2012)(quotation omitted).
"It is well established that a patent is presumed valid, and the burden of persuasion
to the contrary is and remains on the party asserting invalidity." PowerOasis, Inc. v. T-
Mobile USA,Inc., 522 F.3d 1299,1303(Fed. Cir. 2008)(quotation omitted). Accordingly,
"invalidating a claim requires a showing by clear and convincing evidence that the written
description requirement has not been satisfied." Invitrogen Corp. v. Clontech Labs., Inc.,
429 F.3d 1052, 1072 (Fed. Cir. 2005) "Compliance with the written description
requirement is a question of fact but is amenable to summary judgment in cases where no
reasonable fact finder could return a verdict for the non-moving party." PowerOasis, 522
F.3d at 1307.
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In this case, applying the law described above, Judge McCarthy found that no
reasonable fact finder could conclude that Taggart had actually invented (that is, conceived
and constructively reduced to practice) a method for aseptic packaging using oxonia as a
sterilant as of the date the patents in suit were filed. (R&R at 7-11). Accordingly, Judge
McCarthy concluded that claim 40 of the' Patent is invalid for failure to satisfy the
188
written description requirement. {Id.).
Having reviewed the record, the R&R, and all the parties' submissions, and upon
de novo review,the Court finds it to be an exceedingly close question whether the evidence
conclusively demonstrates claim 40 of the '188 Patent is invalid for lack of a written
description. Ultimately, mindful that compliance with the written description is a question
offact on which summary judgment is appropriate only in narrow circumstances,the Court
finds that there are outstanding factual issues that cannot be resolved on the instant record.
Taggarfs testimony (and the other undisputed evidence of record) establishes the
following:(1)the packaging methods described in the patents in suit require the use of a
sterilant that, at a minimum, was capable of achieving FDA approval;(2)as ofthe date the
applications for the patents in suit were filed, oxonia was not an FDA-approved sterilant;
(3) as of the date the applications for the patents in suit were filed, Taggart had no
knowledge as to whether oxonia could achieve the level ofsterilization necessary to satisfy
FDA requirements, but instead stated that if "testing was done and the right data was
presented to the FDA,they might approve it"(Taggart EBT at 227:4-8);(4) Taggart did
-20-
not do any testing to ascertain nor did he ever know "how long you need to expose the
bottle to [oxonia's components], what temperature the [components] need[] to be or what
the airflows need to be to make [the components] meet FDA standards as a bottle sterilant"
{id. at 229:9-19); and (5) Taggart had no knowledge of the effectiveness of oxonia as a
sterilant {id. at 232:6-13). The Court does not disagree with Judge McCarthy that these
facts seriously call into question whether Taggart was capable of satisfying the written
description with respect to a bottling method in which oxonia was the sterilant.
However, the Court finds merit in Plaintiffs argument that the record lacks
information regarding the perspective ofa person ofordinary skill in the art, and that further
discovery is required on this point. "The standard for satisfying the written description
requirement is whether the disclosure allows one skilled in the art to visualize or recognize
the identity of the subject matter purportedly described." Alcon Research Ltd. v. Barr
Labs., Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014)(quotation and alteration omitted); see
also Ariad, 598 F.3d at 1351 (explaining that "whatever the specific articulation, the test
[for written description] requires an objective inquiry into the four comers of the
specification from the perspective of a person of ordinary skill in the art." (emphasis
added)). In particular, "the critical inquiry is whether the patentee has provided a
description that in a definite way identifies the claimed invention in sufficient detail that a
person of ordinary skill would understand that the inventor was in possession of it at the
time of filing." Alcon, 745 F.3d at 1190-91 (quotation omitted).
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In this case,the record is underdeveloped as to what a person of ordinary skill in the
art would have known about oxonia's suitability for use as a sterilant in February of 1999,
when the applications for the patents in suit were filed. In the Court's view, this
underdevelopment of the record prevents a finding of invalidity due to lack of written
description at this stage ofthe proceedings, because what is required to satisfy the written
description requirement "varies with the nature and scope of the invention at issue, and
with the scientific and technologic knowledge already in existence," and the amount of
"descriptive text" needed depends upon "the state ofknowledge in the field and differences
in the predictability of the science." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir.
2005). Moreover, while Taggart's testimony clearly establishes that he did not know
whether his purported "invention" of an oxonia-based system was actually feasible, "an
inventor need not know that his invention will work for conception to be complete."
Burroughs Wellcome Co. v. BarrLabs.,Inc.,40 F.3d 1223,1228(Fed. Cir. 1994). In other
words, because it is not per se necessary that Taggart knew that an oxonia-based aseptic
bottling method could work, and because "[i]n some circumstances, ... a patentee may
rely on information that is well-known in the art for purposes of meeting the written
description requirement,"4/mo'woro Co. v. Int'l Trade Comm 'n,932 F.3d 1342,1359(Fed.
Cir. 2019) (quotation omitted), further discovery into the state of general knowledge
regarding oxonia's suitability as a sterilant at the relevant time is necessary.
-22-
To be clear, the Court does not find that claim 40 of the '188 Patent contains a
sufficient written description. To the contrary, Taggart's testimony at a minimum creates
grave doubts that the written description requirement has been (or could have been)
satisfied.
The Court particularly rejects Plaintiffs argument that the language of
originally-filed claim 12 of the '188 Patent (which identifies oxonia as the sterilant)^ is,
standing alone, sufficient to satisfy the written description requirement or, at a minimum,
to preclude entry ofsummaryjudgment. (See Plaintiffs Objections at 16-17). The Federal
Circuit in Medtronic Navigation, Inc. v. BrainLab Medizinische Computersysteme GmbH,
222 F. App'x 952 (Fed. Cir. 2007) rejected the argument that this sort of unelaborated
"minimal one sentence reference" is sufficient to disclose a claimed invention. Id. at 956-
57 (finding patent claim invalid where it contained "a minimal dropping of an unenabled
reference to an undeveloped [optical] system," but the inventor testified that at the time of
his invention he was not "aware of any commercial optical tracking system that was
available," and the specification therefore did not contain "a disclosure ofan optical system
sufficient to support an interpretation ofa claim as including an optical system"(emphasis
added)). Plaintiffs arguments regarding the language of originally-filed claim 12 are
ultimately inconsistent with well-established case law requiring actual invention to comply
with the written description requirement. Were the Court to adopt Plaintiffs argument and
^
Originally filed claim 12 of the' Patent was cancelled pursuant to an ex parte
188
reexamination certificate issued under 34 U.S.C. § 307 on September 12,2013. (iSeeOystar
Action, Dkt. 238-5 at 27-30).
-23-
hold to the contrary, patentees could effectively preempt future scientific advances by
including in their patent applications unelaborated and untested guesses, resulting in
precisely the kind of"hunting license" the Supreme Court has warned against. Brenner v.
Manson, 383 U.S. 519, 536(1966)("A patent is not a hunting license. It is not a reward
for the search, but compensation for its successful conclusion.").
The Court further rejects Plaintiffs contention that it was improper for Judge
McCarthy to consider conception and reduction to practice in the context of the written
description requirement. Contrary to Plaintiffs argument that conception and reduction to
practice are relevant only to considerations of priority and inventorship (see Plaintiffs
Objections at 12-15), the Federal Circuit has made it clear that, at a minimum, "a
constructive reduction to practice that in a definite way identifies the claimed invention" is
required to satisfy the written description requirement. Ariad, 598 F.3d at 1352. The
Federal Circuit's recent decision in Centrak, Inc. v. Sonitor Techs., Inc., 915 F.3d 1360
(Fed. Cir. 2019), confirms this conclusion. In Centrak, the Federal Circuit expressly
considered whether the evidence of record demonstrated that the inventors "did not . . .
constructively reduce to practice a system with [particular] components" in assessing
whether the written description requirement had been satisfied.
Id. at 1366-67.
Accordingly, issues of conception and reduction to practice may be implicated in
ascertaining whether the written description requirement has been satisfied.
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Moreover, while Plaintiff is correct that "[t]he filing of a patent application serves
as conception and constructive reduction to practice of the subject matter described in the
application" for purposes of establishing priority of invention, even in that context, the
Federal Circuit has explained that the application must "meet the requirements of . . .
§112[.]" Hyatt v. Boone, 146 F3d. 1348, 1352 (1998). In other words, the case law
establishes that a patent application that satisfies the written description requirement is
adequate proof of conception and constructive reduction of practice; however, this case
law does not apply where the written description requirement has not been satisfied. On a
fuller record, it may well be the case that a person of ordinary skill in the art could not
discern from the language of claim 40 of the '188 Patent that Taggart actually conceived
of, or constructively reduced to practice, an oxonia-based system.
For all these reasons, and having reviewed the matter de novo, the Court declines,
at this stage of the proceedings, to adopt the R&R's conclusion that claim 40 of the 188
'
Patent is invalid for lack ofwritten description. The Court further denies, without prejudice
to renewal following additional discovery, the pending summary judgment motions.
V.
Construction of"Asepticallv Disinfecting"
In addition to assessing the validity of claim 40 of the 188 Patent, the R&R also
'
addresses the construction of the phrase "aseptically disinfecting," as it is used in the
patents in suit. (See R&R at 2, 11-12). In particular. Judge McCarthy concluded that
"whatever else it may mean, the phrase cannot validly cover the use of oxonia as the
-25-
sterilant." {Id. at 2).
Judge McCarthy further concluded that "those 'aseptically
disinfecting' claims which do not identify the sterilant should be construed to preserve their
validity by limiting the sterilant to hydrogen peroxide, the only sterilant which has been
properly described." {Id. at 12).
Judge McCarthy's claim construction analysis was informed by and relied upon his
assessment of claim 40 of the '188 Patent's validity. {See First Rule 56(f)(3) Notice at 1
(explaining that, in Judge McCarthy's view, "the phrase 'aseptically disinfecting' . . .
cannot be properly construed without also considering certain validity issues"); Third Rule
56(f)(3) Notice at 1 (stating that "the court's sole focus at this time will be on whether
Thomas Taggart invented a method for aseptically disinfecting containers using oxonia as
the sterilant")). Importantly,Judge McCarthy did not reach a determination on the "various
constructions of 'aseptically disinfecting'" that the parties had proposed, but instead
reached a more limited conclusion based on his validity analysis. (R&R at 2). Under these
circumstances, given the Court's conclusion that further discovery as to claim 40 of the
'188 Patent's validity is required, the Court does not consider the claim construction issue
ripe for review.
Instead, the Court anticipates that, after further discovery and
consideration of the validity issue on a fuller record. Judge McCarthy will be in a position
to also reassess the claim construction issue, after which time the parties may seek review
from the undersigned if they so choose.
-26-
CONCLUSION
For the reasons set forth above, the Court declines to adopt the R&R (Oystar
Action, Dkt. 320; Shibuya Action, Dkt. 424; GEA Action, Dkt. 536; Nestle Action, Dkt.
365; Jasper Action,Dkt.272),and denies without prejudice Defendants' motions for partial
summaryjudgment(Oystar Action, Dkt. 292; Shibuya Action,Dkt.399;GEA Action, Dkt.
506; Nestle Action, Dkt. 335; Jasper Action, Dkt. 245).
SO ORDERED.
ELIZ.(^
United States District Judge
Dated: September 16, 2019
Rochester, New York
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