Nestle USA, Inc.v.Steuben Foods, Inc.

Patent Trial and Appeal Board

Jun 29, 2015

09306552 (P.T.A.B. Jun. 29, 2015)

Trials@uspto.gov Paper 17
571-272-7822 Entered: June 29, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

NESTLÉ USA, INC.,
Petitioner,

v.

STEUBEN FOODS, INC.,
Patent Owner.
____________

Case IPR2015-00023
Patent 6,536,188 B1
____________

Before PHILLIP J. KAUFFMAN, JAMES P. CALVE, and
BEVERLY M. BUNTING, Administrative Patent Judges.

BUNTING, Administrative Patent Judge.

DECISION
Denying Petitioner’s Request for Rehearing
37 C.F.R. § 42.71(d)

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Patent 6,536,188 B1

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I. INTRODUCTION
Nestlé USA, Inc. (“Petitioner”), filed a Petition (Paper 2, “Pet.”) pursuant to
35 U.S.C. §§ 311–319 seeking to institute an inter partes review of claim 40 of
U.S. Patent No. 6,536,188 B1 (Ex. 1001, “the ’188 patent”). The Petition was
docketed as Case IPR2015-00023 (“the ’023 IPR”). Steuben Foods, Inc. (“Patent
Owner”), filed a Preliminary Response to the Petition on February 5, 2015. Paper
8. In our Decision, dated May 4, 2015, we denied the Petition for inter partes
review of claim 40. Paper 14 (“Decision”).
Petitioner now requests rehearing of our decision not to institute inter partes
review. Paper 16 (“Req. Reh’g”). Petitioner’s stated basis for rehearing is that the
Board erred because “(1) it adopted a construction of ‘aseptic’ that is inconsistent
with other Board decisions, is not the broadest reasonable interpretation (“BRI”),
and is per se indefinite; and (2) it applied an enablement standard that ignored the
claimed invention and exceeds what the ’188 patent itself discloses.” Req. Reh’g.
1. In particular, Petitioner requests reconsideration of its assertion that “claim 40 is
obvious over Hayashi in view of Campden, Willhoft, Rose, Oxonia 1997 Label,
Cosentino, Baldry, and Teske.” Id.
As we explain below, we have considered each of the arguments presented
in Petitioner’s Request for Rehearing, but we discern no sufficient reason to
modify the Decision denying institution. As such, Petitioner’s request for
rehearing is denied.

II. STANDARD OF REVIEW
In its request for rehearing, the dissatisfied party must identify, specifically,
all matters the party believes the Board misapprehended or overlooked, and the
place where each matter was addressed previously. 37 C.F.R. § 42.71(d). When
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rehearing a decision denying institution, we review the decision for an abuse of
discretion. 37 C.F.R. § 42.71(c). With this in mind, we address the arguments
presented by Petitioner in turn.

III. DISCUSSION
A. Claim Construction of the term “aseptic”
We first address Petitioner’s argument that “[t]he Board adopted a legally
erroneous construction of ‘aseptic’”. Id. at 3. According to Petitioner, “the Board
has never construed ‘aseptic’ as the Board did in this case,” and characterized the
Board’s change as “unwarranted.” Id. at 6. To support its argument, Petitioner
points to the Board’s construction of the term “aseptic” in another proceeding
involving the ’188 patent and other proceedings involving related patents, and
contends that the Board’s construction of “aseptic” in the present proceeding
contradicts its construction of this same term in other proceedings. Id. at 4–6.
Petitioner’s arguments directed to the claim construction adopted in other
proceedings does not persuade us that we misapprehended or overlooked any
evidence of record in the ’023 IPR. Petitioner does not cite any statute, regulation,
rule or case law requiring that our construction of a specific claim term be identical
in every proceeding. In fact, the Board considers whether to institute an inter
partes review on a case-by-case basis, taking into account the particular facts of
each case. This is why the Decision states clearly that our construction of
“aseptic” is applicable “[f]or purposes of this decision.” Decision. 8. Similarly, in
IPR2014-00055, involving the same patent and claim, the Board stated that this
determination was applicable “[f]or purposes of this decision.” See GEA Process
Engineering, Inc. v. Steuben Foods, Inc., case IPR2014-00055, slip op. at 11
(PTAB March 10, 2014) (Paper 7).
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Nor does Petitioner’s reliance on a claim construction from another
proceeding persuade us that we misapprehended or overlooked any evidence of
record in the present proceeding. In fact, like the Board, Petitioner expressly
restricted its claim construction to apply only to the ’023 IPR. The rules require
that the Petition identify how the challenged claim is to be construed. See
42.C.F.R. § 42.104(b)(3). To satisfy this requirement, Petitioner acknowledged the
Board’s determination in IPR2014-00055, that “[f]or purposes of this decision, we
. . . determined that no claim term needs express interpretation at this time,” and
Petitioner stated in the ’023 IPR that “[f]or purposes of IPR only, Petitioner adopts
the Board’s construction.” Pet. 12. Petitioner, however, mischaracterized the
Board’s statement from the ’055 IPR as an express construction of the claim terms,
which it was not. Notwithstanding this assertion, Petitioner nonetheless proffered
express constructions for two other limitations in claim 40, including “a measuring
device for measuring a quantity of sterilant,” and “wherein the peroxyacetic acid
and hydrogen peroxide uses a concentration sensor to ensure that the concentration
of the peroxyacetic acid and hydrogen peroxide is maintained at a predetermined
level.” Id. at 13–14. Thus, Petitioner proposed constructions for two limitations of
claim 40 in the ’023 IPR, but Petitioner did not propose a construction for any
other terms of claim 40, instead asserting that those terms could be interpreted
according to their “ordinary meaning,” without further elaboration or discussion.
Id. at 12–14. Asserting now for the first time that the term “aseptic” or
“aseptically” should have been construed in a particular manner does not mean that
the Board misapprehended or overlooked anything that was not presented in the
first instance in the Petition, particularly where Petitioner provided no express
construction for that term in the Petition in the first instance. Id. at 12
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Petitioner argues further that our construction of “aseptic” in this proceeding
is not the broadest reasonable interpretation (“BRI”) because other “constructions
of the same term both before and after the Decision—which are ostensibly
‘reasonable’ constructions—are broader.” For the reasons discussed supra,
Petitioner’s argument directed to other proceedings does not persuade us that we
misapprehended or overlooked anything in construing the claim term “aseptic” in
the ’023 IPR.
Next, we consider Petitioner’s argument that the Board’s construction of
“aseptic” renders claim 40 “per se indefinite because (a) there is no ‘FDA level of
aseptic,’ i.e., level of sterilization; and (b) to the extent that the construction
incorporates the FDA’s standards, such as H2O2 residue, the claim is internally
irreconcilable.” Req. Reh’g. 6. To support its argument that the ‘“FDA level of
aseptic’ would be the “FDA level of sterilization’” (id.), Petitioner cites statements
made by Patent Owner during the original prosecution and reexamination of the
’188 patent, passages from the Specification of the ’188 patent, and the FDA
regulation. Id. at 6–8. Petitioner provides no explanation why any good cause
exists to consider these new arguments explicitly discussing the prosecution
history, when such arguments could have been made in the Petition, but were not,
and we decline to do so.
Next, Petitioner contends that “if the Board’s construction of ‘aseptic’ as
‘FDA level of aseptic’ incorporates the FDA’s standards (e.g., the 0.5 ppm residue
standard), then claim 40 is inherently indefinite because it requires a sterilant that
did not meet the FDA standards when the ’188 patent was filed.” Req. Reh’g. 8–9.
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In particular, Petitioner explains that the FDA did not approve the sterilant oxonia1
until after the ’188 patent was filed. Id. at 9. For this reason, Petitioner argues that
claim 40 would be “internally inconsistent and indefinite as a matter of law” if
claim 40 requires compliance with the 1999 FDA standard because oxonia was not
part of the standard at the time. Id. at 10.
Although the FDA had not approved Oxonia as a sterilant, its use was
known by others as well as being described in the ’188 patent. See Ex. 1001, 4:48–
50 (“The present invention uses an aseptic sterilant such as hydrogen peroxide (H2
0 2) or oxonia to sterilize the bottles 12”). Petitioner’s declarant, Dr. Heldman,
confirms that the prior art recognized the FDA requirements, in describing how
“the freedom to modify disinfection parameters would have been constrained by
the material of the container being disinfected and the FDA requirements for
sterilant residue,” the FDA required no greater than .5 ppm H2O2, and that the
sterilant concentration not exceed not exceed 35% H2O2. Ex. 1004 ¶ 23. As to
oxonia in particular, Dr. Heldman stated that “it was also known that the
temperature, concentration, and exposure time also determined the efficacy of
oxonia (i.e., H2O2 and peroxyacetic acid) sterilants.” Ex. 1004, ¶ 24. In our
analysis, we relied on similar evidence presented by Patent Owner. Decision 12
(citing Ex. 1016, 54 and Ex. 2026, 136); see also id. at 7 (noting that “the
Specification indicates that the applicable standard, after container drying, for
residual hydrogen peroxide in the bottle is below about 0.5 PPM.” (citing Ex.
1001, 3:2–5, 4:50–55)); Ex. 1001, 7:21–23 (“The bottles 12 leave the sterilization
chamber 38 with a hydrogen peroxide concentration of less than 0.5 PPM.”),

1 The Specification, as confirmed by Petitioner’s expert, Dr. Heldmen, defines
oxonia as hydrogen peroxide and peroxyacetic acid. Ex. 1001, 13:27–28; Ex. 1004
¶ 24.
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11:56–59 (“The hot sterile air knives 208 also remove the hydrogen peroxide from
the lids 200 so that the residual concentration of hydrogen peroxide is less than 0.5
PPM.”).
As such, Petitioner’s argument that oxonia was not an approved sterilant by
the FDA at the time the ’188 patent was filed does not persuade us that claim 40 is
inherently indefinite or that that we misapprehended or overlooked Petitioner’s
arguments and evidence from the Petition.

B. Enablement of a Prior Art Reference
Petitioner argues that the “Board applied an incorrect standard for
enablement of a prior art reference.” (Req. Reh’g. 10). To support this argument,
Petitioner cites case law pertaining to the level or ordinary skill in the art in an
obviousness analysis, and contends that “a POSITA understood how to build an
aseptic bottling system, and, therefore, the asserted prior art need not contain all of
the details necessary to build an entire system.” Id. Petitioner asserts that Patent
Owner “ignored these precepts in its Preliminary Response, arguing that Hayashi
lacked sufficient detail to ‘reproduce the system disclosed in Hayashi’ and
criticizing Hayashi for lacking features that are not claimed.” Id. at 11 (citing
Prelim. Resp. 13). According to Petitioner, the Board erroneously focused on
features described in the ’188 patent “but not claimed and/or irrelevant to the
Hayashi system” (Req. Reh’g. 12 ) including “how the bottles are rinsed or dried,
explanation of rinsing fluid composition, temperature, and flow rates, as well as the
drying gas composition, temperature and flow rate, that determine sterilant
removal in order to meet the United States FDA level of aseptic.” Id. at 11 (citing
Decision 14–15). These features, according to Petitioner, are not required to
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achieve FDA approval, and are disclosed in Hayashi or have no relevance to
Hayashi’s ability to achieve an “FDA level of aseptic.” Id.
In our Decision, we first considered Petitioner’s challenge of claim 40 as
anticipated under 35 U.S.C. § 102(b) by Hayashi. Pet. 25–39. As we stated in the
Decision, “[w]e are not persuaded that Petitioner’s arguments and evidence
demonstrate sufficiently that the cited portion of Hayashi disclose aseptically
disinfecting the bottles to a level producing at least a 6 log reduction in spore
organism to meet the United States FDA level of aseptic.” Decision 12. Instead,
based on the arguments and evidence of record, we were more persuaded by Patent
Owner’s contention that Hayashi does not disclose that the bottles are aseptically
disinfected to a level producing at least a 6 log reduction in spore organisms to
meet the FDA level of aseptic as recited explicitly in claim 40. Id. at 12–13 (citing
Prelim. Resp. 6–9). Further, we were not persuaded “that Hayashi sufficiently
describes the claimed invention to have placed the public in possession of filling
the aseptically disinfected bottles “at a rate greater than 100 bottles per minute.”
Decision 14.
Next, we considered Petitioner’s challenge of claim 40 as obvious under 35
U.S.C. § 103(a) based on Hayashi, Campden, Willhoft, Rose, Oxonia 1997 Label,
Cosentino, Baldry, and Teske. Petitioner, however, did not rely on any of these
secondary references to solve the above-noted deficiencies in Hayashi. Decision
16–17. Thus, we did not misapprehend or overlook Petitioner’s arguments and
evidence in the Petition; instead, we found them insufficient in view of Patent
Owner’s arguments.
Petitioner now argues that the Board erred by “holding the prior art to a
higher standard of enablement than the ’188 patent itself can satisfy.” Req. Reh’g.
12–15. In particular, Petitioner contends that claim 40 recites that “the sterilant is
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peroxyacetic acid and hydrogen peroxide” (i.e. oxonia), but the ’188 patent “never
describes (1) how oxonia may be used to sterilize bottles, (2) how oxonia
sterilization may reach an ‘FDA level of aseptic’ (particularly given that oxonia
was not FDA-approved), (3) how oxonia sterilization can reach the claimed ‘6-log
reduction in spore organisms,’ or (4) how oxonia sterilization can achieve the
claimed output rates of ‘greater than 100 bottles per minute.’” Id. at 13. Instead,
Petitioner contends that the ’188 patent describes the preferred embodiment of
hydrogen peroxide. Id. Petitioner’s arguments directed to the use of hydrogen
peroxide as a preferred embodiment do not demonstrate that we erred because as
discussed supra, both hydrogen peroxide and oxonia are disclosed in the
Specification of the ’188 patent.
Petitioner also argues that “the ’188 patent is demonstrably less enabling
than Hayashi.” Req. Reh’g. 13–15. Specifically, Petitioner contends that the
EPA-approved label for oxonia requires that oxonia be applied by ‘“immersion,
coarse spray, or circulation techniques’ and removed by ‘thorough draining’
followed by ‘rins[ing] surfaces with a disinfected water rinse free of pathogenic
bacteria or sterile water”’ (Id. at 14 (citing Ex. 1015, 97)) and not vaporizing and
drying. Id. Petitioner’s citation of an EPA standard does not inform us how we
held the prior art to a higher standard of enablement than that of the ’188 patent.
Nor does the citation of an EPA regulation that precludes the use of certain
methods to apply oxonia, demonstrate adequately that such methods are not
technologically feasible. Thus, we did not misapprehend or overlook Petitioner’s
arguments and evidence in the Petition; instead, we found them insufficient in view
of Patent Owner’s arguments.

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IV. CONCLUSION
Therefore, Petitioner has not carried its burden of demonstrating that our
Decision denying institution of inter partes review of claim 40 of the ’188 patent
as obvious based on Hayashi, Campden, Willhoft, Rose, Oxonia 1997 Label,
Cosentino, Baldry, and Teske, misapprehended or overlooked any matters or that
the Board abused its discretion. 37 C.F.R. § 42.71(d).
Accordingly, Petitioner’s Request for Rehearing is DENIED.

PETITIONER:

Thomas Jenkins
Virginia Carron
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
tom.jenkins@finnegan.com
virginia.carron@finnegan.com

PATENT OWNER:

Greg Gardella
Scott McKeown
Ruby Natnithithadha
OBLON, McCLELLAND, MAIER & NEUSTADT, L.L.P.
CPDocketGardella@oblon.com
CPdocketMcKeown@oblon.com
CPdocketRJN@oblon.com