Nestle USA, INCv.STEUBEN FOODS, INC.

Patent Trials and Appeals Board

Jun 2, 2016

09330763 - (D) (P.T.A.B. Jun. 2, 2016)

Trials@uspto.gov Paper No. 97
571-272-7822 Entered: June 2, 2016

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

NESTLÉ USA, INC.,
Petitioner,

v.

STEUBEN FOODS, INC.,
Patent Owner.
____________

Case IPR2015-00195
Patent 6,475,435 B1
____________

Before MICHAEL P. TIERNEY, BEVERLY M. BUNTING, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73

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I. BACKGROUND
Nestlé USA, Inc. (“Petitioner”) filed a Petition requesting an inter
partes review of claims 1–10, 14, 16–21, 25, 27, 29, and 32–36 of U.S.
Patent No. 6,475,435 B1 (Ex. 1001, “the ’435 patent”). Paper 1 (“Pet.”).
Steuben Foods, Inc. (“Patent Owner”) filed a Preliminary Response to the
Petition. Papers 22, 30 (“Prelim. Resp.”). Taking into account the Petition
and Patent Owner’s Preliminary Response, we determined that there was a
reasonable likelihood that challenged claims 1–10, 14, 16–21, 25, 27, 29,
and 32–36 are unpatentable. Pursuant to 35 U.S.C. § 314, we instituted inter
partes review, on June 3, 2015, as to those claims of the ’435 patent. Paper
38 (“Inst. Dec.”); Paper 51 (redacted version).
After institution, Patent Owner filed a Patent Owner Response. Paper
57 (“PO Resp.”). Petitioner filed a Reply to the Patent Owner Response.
Paper 61 (“Pet. Reply”). In accordance with our authorization (Paper 69),
Patent Owner filed a Sur-Reply addressing the arguments presented on
pages 6–9 of Petitioner’s Reply. Paper 76 (“PO Sur-Reply”).
Additionally, Patent Owner filed a Motion to Exclude Evidence
(Paper 73), to which Petitioner filed an Opposition (Paper 79). Patent
Owner filed a Reply in Support of its Motion to Exclude (Paper 85).
Petitioner also filed a Motion to Exclude Evidence (Paper 75), to which
Patent Owner filed an Opposition (Paper 80). Petitioner filed a Reply to
Patent Owner’s Opposition to its Motion to Exclude (Paper 84).
A hearing was held on January 27, 2016, a transcript of which appears
in the record. Record of Oral Hearing, Paper 92 (“Tr.”).
We have jurisdiction under 35 U.S.C. § 6(c). This decision is a Final
Written Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 as to the
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patentability of the challenged claims. For the reasons discussed below, we
determine that Petitioner has shown by a preponderance of the evidence that
claims 1–10, 14, 16–21, 25, 27, 29, and 32–36 are unpatentable.
A. Related Proceedings
The parties identify several related matters, including the pending
litigation in the U.S. District Court for the Western District of New York:
Steuben Foods, Inc. v. Nestle, USA, No. 1:13-cv-00892 (filed Sept. 3, 2013).
Pet. 58–59; Paper 8, 2–3. The ’435 patent was challenged in IPR2014-
00043 (terminated). Pet. 58–59; Paper 8, 2–3; GEA Process Eng., Inc. v.
Steuben Foods, Inc., Case IPR2014-00043 (PTAB Dec. 23, 2014) (Paper
114). The ’435 patent is also the subject of ex parte reexamination
proceedings (control nos. 90/012,135 and 90/013,458), which have been
merged and are currently ongoing.
B. The ’435 Patent (Ex. 1001)
The ’435 patent claims the benefit of the filing date of a provisional
application filed on February 2, 1999. Ex. 1001, [22], [60], 1:6–7.
The ’435 patent is directed to an apparatus and method for providing
sterilization zones in an aseptic packaging sterilization tunnel that surrounds
a plurality of containers with pressurized gas. Id. at 1:12–14, 3:30–31. The
sterilization tunnel comprises a plurality of sterile zones created by a
plurality of partitions and a plurality of hot sterile air supply sources (e.g.,
conduits). Id. at 2:46–48, 3:20. In particular, the ’435 patent describes a
first sterilization zone that includes an activation and drying apparatus, a
second sterilization zone that includes the main product filler apparatus and
lid sterilization and heat sealing apparatus, a third sterilization zone that
includes a bottle discharge apparatus, and a fourth sterilization zone that
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includes an interior bottle sterilization apparatus. Id. at 9:29–39. An
annotated version of Figure 3 of the ’435 patent is reproduced below:

The Figure above shows the first sterilization zone 164 (blue), the second
sterilization zone 166 (red), the third sterilization zone (green), and the
fourth sterilization zone (orange). Sterile air is supplied to the sterilization
tunnel via a number of interfaces, including “through conduit 148” and
“conduits 140, 142, and 144.” Id. at 10:3–9. Sterile air is applied directly to
bottles via a “plurality of nozzles” to activate and dry a hydrogen peroxide
(H2O2) sterilant. Id. at 10:32–45. Additionally, sterile air can exit the
tunnel from various interfaces at different rates, including “through a
plurality of exhaust ports 153 located in the first sterilization zone 164” at a
rate of about 1500 cfm, “through an opening 282” at a rate of about 100 cfm,
and “out of the exhaust conduit 70 of the infeed and sterilization apparatus at
a rate of about 3600 cfm.” Id. at 10:12–17, 10:24-28. Partitions 130A,
130B, and 130C help control sterile air flow within the sterilization tunnel,
and are provided with “cut-outs” to allow bottles and the conveyer belt to
pass through. Id. at 8:62–9:8.
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The aseptic sterilant used in the apparatus may be H2O2 with a
concentration of less than about 35%. Id. at 2:23–24, 5:2–4. “The sterile
zones provide a plurality of sterilant concentration levels within the
sterilization tunnel.” Id. at 2:48–50, 3:20–21, 16:52. For example, the ’435
patent provides an embodiment wherein the sterilant concentration is highest
at about 1000 parts per million (ppm) in the bottle sterilizer zone. Id. at
9:38–39, 9:51–10:2. In contrast, the sterilant concentration is the lowest,
less than 0.5 ppm and typically about 0.1 ppm, in the filling zone, thereby
preventing unwanted high levels of sterilant to enter the food product during
filling. Id. at 9:59–66. In addition, the sterile zones have a plurality of gas
flow rates within the sterilization tunnel, wherein gas flow is in the direction
from the first sterilization zone to the fourth sterilization zone. Id. at 2:50–
51, 3:39–40, 9:48–50.
C. Illustrative Claim
Petitioner challenges claims 1–10, 14, 16–21, 25, 27, 29, and 32–36 of
the ’435 patent. Claims 1, 4, 17, and 33 are independent claims. Claim 1 is
illustrative and is reproduced below:
1. Apparatus comprising:
a sterilization tunnel for surrounding a plurality of
containers with pressurized gas; and
a plurality of zones within the sterilization tunnel having
different sterilant concentration levels therein wherein the
sterilant concentration levels in the plurality of zones are
maintained at a ratio of at least about 5 to 1.
D. Grounds for Unpatentability
We instituted inter partes review of the ’435 patent based upon the
following grounds of unpatentability:
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A. Obviousness of claims 1–10, 14, 16–21, 25, 27, 29, and
32–36 over Scholle,1 Chambers,2 the FDA Regulations,3
Biewendt,4 Kelbrick,5 Elliott,6 Akai,7 and Kodera;8
B. Obviousness of claims 1–10, 14, 16–21, 25, 27, 29, and
32–36 over Biewendt, Chambers, the FDA Regulations,
Buchner,9 ZFL,10 Scholle, Kelbrick, Akai, Kodera, and
Elliott.

Inst. Dec. 27.

1 U.S. Patent No. 4,417,607 for “Apparatus and Method for Aseptically
Filling Flexible Containers,” issued November 29, 1983 to William R.
Scholle, et. al. (“Scholle”) (Ex. 1005).
2 J. Chambers et al., Principles of Aseptic Processing and Packaging, The
Food Processors Institute (2d ed. 1993) (“Chambers”) (Ex. 1014).
3 21 C.F.R. § 178.1005 (Apr. 1, 1996) (“FDA Regulations”) (Ex. 1013).
4 H.-G. Biewendt et al., Report on the Type Testing of the Aseptic Filling
and Sealing Plant for Glass Bottles for UHT Milk (1996) (“Biewendt”) (Ex.
1024). Ex. 1024 replaces the version of Biewendt originally filed with the
Petition (Ex. 1006).
5 U.S. Patent No. 5,534,222 for “Method for Sterilizing Internal Surfaces of
an Edible Liquid Packaging Machine,” issued July 9, 1996, to William J.
Kelbrick, et. al. (“Kelbrick”) (Ex. 1007).
6 P. Elliott et al., Microbiologists Evaluation of Low- Acid Aseptic Fillers, J.
Food Tech. (May 1992) (“Elliott”) (Ex. 1015).
7 EP 0 384 535 for “Apparatus for supplying hydrogen peroxide for
sterilization” published August 29, 1990, listing inventors Tado Akai et al.
(“Akai”) (Ex. 1008).
8 U.S. Patent 4,427,772, issued January 24, 1984 to Yasuo Kodera et al.
(“Kodera”) (Ex. 1009).
9 N. Buchner, Aseptic Production and Filling Methods in the Pharmaceutical
and Foodstuff Industries, Pharma Technologie Journal, Concept Heidelberg
(including translation) (“Buchner”) (Ex. 1011).
10 N. Buchner, Aseptic Filling of Glass and Plastic Containers, ZFL
Magazine (1989) (“ZFL”) (Ex. 1010).
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II. DISCUSSION
A. Time Bar Under 35 U.S.C. § 315(b)
Patent Owner contends that GEA Process Engineering, Inc. (“GEA”)
was served with a complaint alleging infringement of the ’435 patent more
than one year before the Petition was filed, and because GEA is a privy of
Petitioner, the Petition is time barred under 35 U.S.C. § 315(b). See PO
Resp. 43–54. Prior to institution, Patent Owner’s arguments regarding
privity were based primarily on Petitioner’s agreement to indemnify GEA as
part of Petitioner’s purchase of a bottling machine from GEA (“the Line 8
Agreement,” Ex. 2046).11 Prelim. Resp. 5–32.
The question of whether Petitioner is time-barred under § 315(b) is
considered part of the determination of whether to institute an inter partes
review. See Achates Reference Publ’g, Inc. v. Apple Inc., 803 F.3d 652,
657–59 (Fed. Cir. 2015). In our Institution Decision, we determined that the
district court complaint filed by Patent Owner against GEA did not time bar
the Petitioner under § 315(b) because Patent Owner had not provided a
sufficient factual basis upon which to conclude that Petitioner and GEA are
privies.12 See Inst. Dec. 6–17. In particular, we were not persuaded that the
Line 8 Agreement shows that Petitioner and GEA have a substantive legal
relationship or that Petitioner and GEA shared control of this inter partes

11 Petitioner purchased seven bottling machines from GEA and GEA’s
predecessor, Procomac SpA. Paper 81, 2. These seven machines were
purchased in three groupings: (1) lines 1–5, (2) line 6/7, and (3) line
8. Patent Owner explains that line 7 is sometimes referred to as line 6, and
for that reason we refer to it as “line 6/7.” Paper 87, 2 n.3.
12 Patent Owner’s exhibits 2001–2046 were entered prior to
Institution. Patent Owner Exhibits 2047–2065 were submitted in
conjunction with the Patent Owner Response (post-institution).
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review and/or the related litigation in the manner required for a privity
relationship. Id. We incorporate that analysis here, and reconsider Patent
Owner’s contention only to the extent it is warranted by subsequent
argument and evidence.13 See Achates, 803 F.3d at 658 (“The Board’s
reconsideration of the time-bar [in the final determination] is ‘still fair[ly]
characterize[ed] as part of the decision to institute.”) (citations omitted).
Since our Institution Decision, the only new arguments made by
Patent Owner with regard to its privity assertion relate to the purchase of
certain other aseptic bottling machines, as reflected in the agreements for
lines 1–6/7. According to Patent Owner, Petitioner and GEA are privies
because these agreements obligate Petitioner to indemnify GEA for lines 1-
6/7 in addition to the indemnification for line 8. PO Resp. 43–54. Patent
Owner makes three supporting contentions.
First, Patent Owner contends that the machines purchased by
Petitioner for lines 1–6/7 were made and built to Petitioner’s specifications,
quoting the following excerpt from Exhibit 2011:
GEA Procomac designs and manufactures complete customized
bottling plants. The scope of supply range from individual units
and systems to complete integrated bottling lines including:
• Aseptic and sanitary fillers
• Blow-fil systems for PET bottles
• Container treatment systems (rinsers and sterilizers)
• Palletizing and de-palletizing systems
• Conveyors and bottle / PET handling systems

13 In IPR2014-01235, another inter partes review between these parties, the
Board determined in a Final Written Decision on similar facts, that Patent
Owner had not provided a sufficient factual basis upon which to conclude
Petitioner and GEA are privies. (PTAB Dec. 21, 2015) (Paper 63, 5–10).
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PO Resp. 44 (citing Ex. 2011). Exhibit 2011 is printout of a website that is
dated January 22, 2015, titled “GEA Procomac Bottling Plants.” The
Exhibit does not mention the sale of lines 1–6/7 to Petitioner. Although the
Exhibit states that GEA Procomac was acquired by GEA Group in April
2007, the Exhibit neither states nor implies how long GEA Procomac had
been designing and manufacturing customized bottling plants.
Second, Patent Owner asserts that Petitioner was subject to the
version of the Uniform Commercial Code adopted as the California
Commercial Code, citing Exhibit 2062 as proof of where Petitioner does
business. PO Resp. 45. Exhibit 2062 provides no information about the
purchase of lines 1–6/7. Moreover, Patent Owner’s arguments regarding the
California Commercial Code rely upon an alleged indemnification
obligation based on Petitioner’s purchase of custom-made machines. PO
Resp. 46. We previously held, with respect to the Line 8 Agreement, that
indemnity does not create the type of substantive legal relationship that
amounts to privity. Inst. Dec. 12–15.
Third, Patent Owner asserts that Petitioner has refused to produce the
joint defense agreement between GEA and Petitioner. PO Resp. 48 (citing
Ex. 2013). Exhibit 2013 is an email chain regarding a request from Patent
Owner’s counsel to Petitioner’s counsel for any agreements between
Petitioner and GEA that form the basis of a joint defense privilege, and the
subsequent discussion. Ex. 2013, 8. We previously denied Patent Owner’s
motion to authorize a request for production of the joint defense agreement
(JDA) between Petitioner and GEA. Paper 21. We noted that “Patent
Owner does not state what useful information is to be gained from the JDA
document sought, other than proving what is already acknowledged, that a
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JDA exists between Petitioner and GEA.” Id. at 3. More importantly, our
prior analysis in the Institution Decision examined the joint defense
relationship between Petitioner and GEA and explained that such
relationship does not demonstrate privity. Inst. Dec. 11–12.
Petitioner’s new arguments and evidence do not persuasively
demonstrate that the machines purchased as lines 1–6/7 were built to
Petitioner’s specification, nor has Patent Owner demonstrated persuasively
that the purchase agreements otherwise created privity between GEA and
Petitioner. Even if the agreements for lines 1–6/7 were similar to the Line 8
Agreement as Patent Owner contends, we examined the relationship created
by the Line 8 Agreement in detail, and determined that Petitioner and GEA
were not privies. See Inst. Dec. 6–17. Given this, Patent Owner has added
nothing new of significance since our Institution Decision.
It is worth noting that after Patent Owner’s Response was submitted,
Patent Owner sought and was denied additional discovery relating to the
agreements for lines 1–6/7. Paper 77 (Patent Owner’s Motion for
Discovery), Paper 81 (Opposition), Paper 87 (Decision denying discovery).
Also of note, our order regarding oral argument limited the parties to present
arguments related to privity only to the extent that additional evidence came
of record after institution of trial. Paper 83. At oral hearing, Patent Owner
did not present any arguments on the merits regarding privity; rather, Patent
Owner proffered an email indicating the possibility that additional
information would be obtained from the related litigation. Tr. 68–75; see
also Paper 88 (entering the email as Board Exhibit 3001, and noting that the
email contained nothing of substance). Since that time, Patent Owner has
not sought to enter any such information into the record.
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Accordingly, we decline to reconsider our prior decision that the
Petition is not time barred under § 315(b) based on Petitioner’s relationship
with GEA.
B. Claim Construction
We interpret the claims of an unexpired patent using the broadest
reasonable construction. See 37 C.F.R. § 42.100(b). Under the broadest
reasonable construction standard, claim terms are given their ordinary and
customary meaning, as would be understood by one of ordinary skill in the
art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007).
Based on the evidence of record at the time, we did not construe any
claim terms in our Institution Decision. Inst. Dec. 17–18. Patent Owner, in
its Patent Owner Response, argues that “sterilant concentration level” and
“surrounding a plurality of containers with pressurized gas” require
construction. PO Resp. 4–11. Petitioner, in its Reply, challenges Patent
Owner’s construction of “sterilant concentration level.” Reply 3–5. We
construe only those terms which are in controversy, and only to the extent
necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. &
Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Now, with the entire record
fully developed, we address the party’s contentions regarding “sterilant
concentration levels” below and determine that no other term requires
express construction.
Sterilant Concentration Levels
Patent Owner asserts that the broadest reasonable interpretation of the
phrase “sterilant concentration levels” recited in the claims is “the amount of
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airborne sterilant within a given zone.” PO Resp. 10. Patent Owner
contends that the plain and ordinary meaning of the phrase is “the amount of
sterilant in the volume of pressurized gas in a given zone,” and notes that
sterilant concentration level can be expressed in “parts of sterilant” per
“million parts gas” (ppm). Id. at 4. As support for its construction, Patent
Owner points to the statement in the specification that “[t]he partitions
130A, 130B, and 130C create sterilization zones 164, 165, 166, and 172 with
different concentration levels of gas laden sterilant (e.g., hydrogen peroxide
in air).” Id. at 5 (citing Ex. 1001, 9:51–53). Patent Owner further asserts
that the specification’s subsequent reference to concentration levels of H2O2
in different zones in terms of “ppm” refers to airborne concentrations. Id.
(citing Ex. 1001, 9:54–10:2). Patent Owner also relies upon its expert,
Andre Sharon, Ph.D., who concurs that the skilled artisan “would read the
claims as referring to the airborne sterilant concentration within the zones as
opposed to the sterilant concentration in the solution in the sterilant tank, or
sterilant remaining in the bottles that are within the zone.” Id. at 6 (citing
Ex. 2056, ¶ 19).
Petitioner argues that Patent Owner’s proposed construction of
“sterilant concentration levels” should be rejected because the term
“airborne” appears nowhere in the ’435 patent claims or specification.
Reply 3. Moreover, Petitioner contends that Patent Owner took a different
position in its infringement contentions during the related litigation. Id.
Petitioner also contends that Patent Owner’s construction is ambiguous
insofar as it does not address where the airborne concentration should be
measured. Id. at 5.
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We determine that the broadest reasonable interpretation consistent
with the specification does not limit the claimed “sterilant concentration
levels” to only airborne concentrations. We recognize that the specification,
in one instance, refers to zones with “different concentration levels of gas
laden sterilant (e.g., hydrogen peroxide in air).” Ex. 1001, 9:51–53. The
specification, however, refers elsewhere to the “residual concentration” of
H2O2, measured in terms of ppm. Id. at 12:46–47 (“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.”)
(emphasis added); see also id. at 11:15–17 (“After bottle 12 has dried, the
residual hydrogen peroxide remaining on the bottle 12 surface is less than
0.5 PPM.”) (emphasis added).
Patent Owner acknowledges that “[o]ther discussions of ppm within
the specification are in the context of residual sterilant on the bottle,” which
is measured in accordance with the FDA Regulations (21 C.F.R
§ 178.1005(d) (Ex. 1013)) as the concentration in distilled water, but
nonetheless asserts that “[t]his is consistent with the definition of ‘sterilant
concentration’ in the context of the claim [as] parts of sterilant per million
parts of carrier gas.” PO Resp. 6. However, insofar as it is undisputed that
“residual” sterilant concentrations on the bottle surface are disclosed in the
specification and encompassed by the claim scope, Patent Owner does not
explain why the skilled artisan would have understood such a concentration
would be measured as parts of sterilant per million parts of carrier gas (i.e.,
airborne) as opposed to parts of sterilant per million parts of distilled water
in accordance with the FDA Regulations. See Ex. 1013, 326 (“No use of
hydrogen peroxide solution in the sterilization of food packaging material
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shall be considered to be in compliance if more than 0.5 part per million of
hydrogen peroxide can be determined in distilled water packaged under
production conditions.”). In short, neither the claims nor the specification
limit how or where within “the plurality of zones” the sterilant concentration
levels should be assessed in order to determine whether the 5 to 1 ratio is
satisfied. As such, we find no basis to limit the claimed sterilant
concentration levels to only airborne concentrations.
C. Overview of the Prior Art
1. Scholle (Ex. 1005)
Scholle is directed to an “Apparatus and Method for Aseptically
Filling Flexible Containers.” Ex. 1005, Title. Scholle describes an
apparatus in which empty “presterilized” containers are fed through an entry
port into a “tunnel-like, elongated chamber” for sterilization and filling. Id.
at Abstract, 1:52–57. The chamber is “partitioned into three compartments,
including a sterilizing compartment . . . a filling compartment . . . and a
drying compartment, interposed” therebetween. Id. at 1:57-62. The
chamber also has “an entry port, through which the empty containers are fed,
and a dispensing port, through which the filled containers are dispensed,”
which “each have a seal, formed of elastomeric material with a slit therein,
to reduce the risk of contaminant migration into the elongated chamber
while permitting the containers to pass therethrough.” Id. at 1:54–57, 63–66.
In operation, “[a] supply of sterilized air is continuously input to the
filling compartment to pressurize the entire elongated chamber and provide a
flow of sterile air therethrough to prevent entry of contaminants.” Id. at
1:67-2:2. Scholle teaches using “a 30-percent solution of hydrogen peroxide
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in water [i.e., 300,000 ppm H2O2]” as a sterilant. Id. at 5:18-22. Spray
heads “atomize the hydrogen peroxide solution into a fine mist or fog, and
spray such mist into the spraying compartment [], drying compartment [],
filling compartment [], and dispensing mouth [], respectively.” Id. at 5:22–
26. Additionally, the flow of sterile air within the chamber maintains a
positive pressure in the filling and drying compartments, which “reduces any
tendency of the hydrogen peroxide mist in the spray compartment [] to
migrate through the opening” in the partition dividing the compartments. Id.
at 5:36–43, 6:36–43.
2. Chambers (Ex. 1014)
The Chambers reference is an excerpt from a book entitled “Principles
of Aseptic Processing and Packaging” (Ex. 1014). Chambers teaches that the
FDA approved the use of H2O2 for sterilization of aseptic packaging
materials in 1981, but FDA regulations placed a limit of a final
concentration of not more than 0.5 ppm after packaging.” Id. at 60.
Chambers further teaches that “[m]any aseptic packaging systems use H2O2
at concentrations of 30 to 35%.” Id.
3. The FDA Regulations (Ex. 1013)
The FDA Regulations relied upon as prior art are set forth in the April
1, 1996 edition of 21 C.F.R. § 178.1005 (Ex. 1013). The FDA Regulations
indicate that “hydrogen peroxide is an aqueous solution containing not more
than 35 percent hydrogen peroxide . . . by weight.” Id. at 326. Further, it
provides that “[n]o use of hydrogen peroxide solution in the sterilization of
food packaging material shall be considered to be in compliance if more
than 0.5 part per million of hydrogen peroxide can be determined in distilled
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water packaged under production conditions (assay to be performed
immediately after packaging).” Id.
4. Biewendt (Ex. 1024)
The Biewendt reference, translated from German, is entitled “Report
on the Type Testing of the Aseptic Filling and Sealing Plant for Glass
Bottles for UHT [Unit Heat Treatment] Milk.” Ex. 1024 at 1. The reference
describes a system and process for aseptic sterilization and packaging of
bottles developed by Robert Bosch GmbH (the “Bosch” system). “The
complete process . . . . comprises the sterilization of the plant and the bottles,
filling the milk into said bottles and sealing the bottles (=Production), as
well as cleaning the plant after production is completed.” Id. at 11. The
Bosch system is depicted as comprising several interconnected sections or
machines, including the bottle sterilizing machine, the aseptic filling
machine, an aseptic tunnel, with a relatively reduced cross-section, that
connects the sterilizing and filling machines, and the aseptic sealing
machine. Id. at 2. In the bottle sterilization machine, during transport, the
bottles are “sprayed with hydrogen peroxide (H2O2)”. Id. at 3. In the
aseptic filling machine, prior to filling, the bottles are “universally fogged
with a warm hydrogen peroxide (H2O2) air mixture of defined concentration
for a specified time and then universally blown dry with heated air.” Id. at
17.
“To maintain aseptic conditions until production is completed, the
sterilized aseptic areas of the plant are [] supplied with sterile air by the
aseptic supply unit; the pressure of the aseptic supply unit is kept
continuously around 20 Pa above the atmospheric pressure.” Id. at 13; see
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also id. at 18 (“The housing in which the sterilized bottles are transported,
filled, and sealed, which is encapsulated from the atmosphere . . . . is loaded
with sterile air until production is completed; the pressure of said air is kept
approx. 20 Pa above the atmospheric pressure.”). The sterilization media
comprises a “minimum 33% H2O2”. Id. at 11. Regarding the effectiveness
of this sterilization method, the reference states that “[t]esting with
Merckoquant 10 001 testing strips did not show any proof of contamination
with H2O2 residue in filled UHT milk bottles.” Id. at 18.
5. Kelbrick (Ex. 1007)
Kelbrick is directed to a “Method for Sterilizing Internal Surfaces of
an Edible Liquid Packaging Machine.” Ex. 1007, Title. Kelbrick discloses
aseptic sterilization of containers whereby the containers are “first sprayed
with aqueous hydrogen peroxide (preferably 33% H2O2) by means of a
spray nozzle [], followed immediately by exposure of the sprayed containers
to a series of hot air nozzles . . .” Id. at 2:34–37.
6. Elliott (Ex. 1015)
The Elliott reference is entitled “Microbiological Evaluation of Low-
Acid Aseptic Fillers.” Ex. 1015 at 116. The article discusses the methods
used to establish critical factors for aseptic fillers and demonstrates the need
for standardization. Id. The article describes how the operational limits for
several critical factors or a “window of operation” for container sterilization
can be created “by varying the peroxide dosage/container and the heated air
temperature.” Id. One edge of the “window of operation” is created “by
varying these two critical factors to give the maximum allowable peroxide
residual of 0.5 ppm/container (21 CFR 178.1005).” Id. at 117.
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7. Akai (Ex. 1008)
Akai is directed to an “Apparatus for supplying hydrogen peroxide for
sterilization.” Ex. 1008, Title. Akai discloses that the containers which are
to be sterilized are sprayed with an aqueous solution of hydrogen peroxide.
Id. at 2. The atomized solution is entrained by a stream of air and applied to
the containers. Id. In order to maintain the predetermined concentration of
atomized H2O2, which partially decomposes into a gas when heated, Akai
discloses a control system comprising a sensor for detecting the
concentration of atomized H2O2. Id.
8. Kodera (Ex. 1009)
Kodera is directed to an “Apparatus Having Automatic Calibration for
Determining Hydrogen Peroxide Concentration.” Ex. 1009, Title. Kodera
describes a sterilization system to automatically determine and control the
concentration of H2O2 in an aqueous solution of a sterilant supply. Id. at
5:14–17.
9. Buchner (Ex. 1011)
The Buchner article is entitled “Aseptic Production and Filling
Methods in the Pharmaceutical and Foodstuff Industries.” Ex. 1011, Title.
Buchner describes a pilot sterilization plant for aseptic filling and sealing of
bottles. Id. at 26. While being transported through the various stations
within the plant, the bottles are sprayed with H2O2. Id. The entire plant has
completely closed aseptic spaces that are subject to a slight overpressure of
sterile air. Id. at 4. The plant can achieve a residual peroxide concentration
less than 0.5 ppm. Id.
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10. ZFL (Ex. 1010)
The ZFL reference, also authored by Buchner, is entitled “Aseptic
Filling of Glass and Plastic Containers.” Ex. 1010 at 295. The reference
presents a newly developed filling line which is able to fill containers under
aseptic conditions. Id. The system sterilizes containers with vaporized
H2O2. Id. at 296. By adjusting sterilizing conditions such as sterilant flow
rate, temperature, and peroxide concentration, the system can achieve a
residual peroxide concentration in the containers of less than 0.5 ppm. Id. at
297.
D. Obviousness Challenges

Petitioner contends that claims 1–10, 14, 16–21, 25, 27, 29, and 32–36
would have been obvious under 35 U.S.C. § 103(a) over Scholle in view of
one or more of Chambers, the FDA Regulations, Biewendt, Kelbrick, Elliott,
Akai, and Kodera. Pet. 19–38. Petitioner also contends that the same claims
would have been obvious over Biewendt in view of one or more of
Chambers, the FDA Regulations, Buchner, ZFL, Scholle, Kelbrick, Akai,
Kodera, and Elliott. Id. at 39–58. Petitioner relies upon the Declaration of
Dennis Heldman, Ph.D (Ex. 1004) in support of these challenges.14

14 Petitioner asserts that a person of ordinary skill in the art (“POSITA”)
would possess “an undergraduate scientific or engineering degree in a
relevant field (such as microbiology or mechanical, packaging, process, or
food engineering), at least five years of experience in an aseptic packaging
and/or processing field (or a graduate degree conferring similar expertise),
and an understanding of the relevant principles of microbiology and food
science and technology.” Pet. 12; Ex. 1004, ¶ 12. Patent Owner has not
contested that definition in its Patent Owner Response, but its expert Dr.
Sharon asserts that Petitioner’s definition is only partially correct insofar as
it does not recognize that the POSITA could have a mechanical engineering
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Patent Owner’s arguments are directed primarily to the sterilant
concentration ratio requirement recited in each of the challenged
independent claims 1, 4, 17, and 33. Specifically, the challenged claims all
require that the sterilant concentration levels in the plurality of zones within
the sterilization tunnel “are maintained at a ratio of at least about 5 to 1.”
Accordingly, we focus on that limitation, and treat the claims together for
purpose of our analysis.
1. Scholle in view of Chambers, the FDA Regulations,
Biewendt, Kelbrick, Elliott, Akai, and Kodera
Petitioner asserts that, using partitions and pressure differentials, the
apparatus of Scholle (Ex. 1004) is configured to prevent the H2O2 sterilant
from migrating from the sterilizing compartment to the drying and filling
compartments, and, thus, the sterilant concentration in the sterilization
compartment of Scholle is necessarily different from the concentration in the
drying and filling compartments. Pet. 20 (citing Ex. 1004 ¶ 55; Ex. 1005,
6:36–41). Petitioner also points to Scholle’s teaching of using a 30%
solution of H2O2 in water (i.e., 300,000 ppm) as a sterilant (id. at 21 (citing
Ex. 1004 ¶ 56; Ex. 1005, 5:18–22)), and asserts that the skilled artisan
“would understand that to ensure consistent sterilization and residual
peroxide levels, the concentration of applied sterilant must necessarily be
‘maintained.’” Id.

degree. Ex. 2056, ¶ 12. We note, however, that Petitioner has included
mechanical engineering as a “relevant field” within its definition.
Accordingly, we apply Petitioner’s proposed level of skill in the art in our
analysis.
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Petitioner further argues that Chambers discloses that “[m]any aseptic
packaging systems use H2O2 at concentrations of 30 to 35% and 80 to 90°C
for 3 to 5 sec . . . followed by hot air (60 to 125°C)” to sterilize packaging
materials. Id. (citing Ex. 1014, 17). Additionally, Petitioner asserts that the
FDA limits the residual concentration of H2O2 to “not more than 0.5 ppm
after packaging.” Id. (citing Ex. 1013, 1). Based on these teachings,
Petitioner argues that “it would have been obvious in view of Chambers
and/or the FDA Regulations to limit residual hydrogen peroxide and, by
extension, to maintain a particular sterilant concentration ratio between the
30 percent applied hydrogen peroxide and the residue in filled and capped
containers.” Id.
Patent Owner, in its Patent Owner Response, challenges whether the
maintenance of a ratio of air borne sterilant concentration as between or
among zones was a known result effective parameter. PO Resp. 11–18.
Relying on its proposed claim construction requiring a ratio of airborne
sterilant concentration of at least 5 to 1, Patent Owner argues that the
maintenance of a ratio of airborne sterilant concentration as between or
among zones was not a known result-effective parameter, and thus the
skilled artisan would not have been concerned with optimizing the ratio of
airborne sterilant concentrations in the prior art systems. Id. at 11–21. As
discussed above, however, we do not construe the claims to require that the
5 to 1 ratio is based on a measurement of airborne sterilant concentration.
Based on the arguments and evidence of record, we determine that the
claimed invention is rendered obvious so long as the skilled artisan would
have had sufficient motivation and a reasonable expectation of success with
respect to the optimization of sterilant concentration levels measured at any
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point within the sterilization tunnel—including the “residual” concentration
on bottle surfaces—such that the 5 to 1 ratio is satisfied.
A preponderance of the evidence supports the conclusion that the
skilled artisan would have found it obvious to optimize the sterilant
concentration levels within the different “zones” (i.e., compartments) of
Scholle’s apparatus in such a manner. Several features of Scholle’s
apparatus facilitate such an optimization. First, a 30-percent solution of
H2O2 in water is atomized and continuously sprayed into the spraying
compartment during operation. Ex. 1005, 5:18–26, 45–49. Second, the
spraying zone is separated from other compartments by a partition with a
narrow opening designed “to reduce the amount of [H2O2] mist passing
through the opening.” Id. at 6:12-15. Third, in the drying compartment, the
H2O2 is “evaporated” and vented out of the sterile tunnel. Id. at 6:33-36, 44-
55. And finally, the sterile air maintains a positive pressure in the filling and
drying compartments, thus reducing any tendency of the H2O2 mist in the
spray compartment to migrate through the narrow opening into those other
compartments. Id. at 5:36–43, 6:36-41. Although the parties dispute the
particular concentration of H2O2 that exists in the sterilization tunnel after it
is sprayed, there is no dispute that the spraying compartment in Scholle’s
apparatus will have a higher sterilant concentration than the filling
compartment. Indeed, even if airborne concentration levels were to be
considered, Patent Owner’s counsel acknowledged during oral argument that
“there is going to be more sterilant in the air in the spray zone than in the fill
zone.” Tr. 122:12–14; see also Ex. 1035, 122:21–123:3 (Patent Owner’s
expert Dr. Sharon conceding that the airborne concentration is lower in the
fill zone than in the spray zone).
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Furthermore, we find that the concentration of the 30% solution of
H2O2 will remain close to 300,000 ppm in the liquid phase at some point
after it is sprayed into the spraying compartment. Scholle discloses that the
spray heads atomize the H2O2 solution into a “fine mist or fog,” which coats
the exterior of the containers to kill microorganisms. Ex. 1005, 5:22–23,
8:8–13. Although Dr. Sharon asserts that the skilled artisan “would be
motivated to use as little sterilant in the sterilization zone as necessary to get
the job done” (Ex. 2056, ¶24), he nonetheless acknowledged that, after
condensation, the concentration of liquid H2O2 that coats the containers is
“somewhere in the neighborhood” of 30%, or 300,000 ppm. Ex. 1035, Tr.
105:17–106:15. Here, we also credit Dr. Heldman’s testimony who stated
that although the process of atomizing H2O2 may “result in varying
concentrations,” the skilled artisan nonetheless “would understand that to
ensure consistent sterilization and residual peroxide levels, the concentration
of applied sterilant must necessarily be ‘maintained.’” Ex. 1004 ¶¶ 51, 56.
Patent Owner argues that Dr. Heldman agreed that it would be
reasonable to assume that the airborne concentration of H2O2 could drop by
a factor of 100 between the time it is taken from the tank and put through an
atomizer, and that it would be reasonable to assume that the concentration
would drop by another factor of 100 once it is injected into the sterilization
tunnel of Scholle. PO Resp. 26 (citing Ex. 2055, 56:2–57:24, 95:1–98:9,
188:21–190:19). As a result, Patent Owner argues that the airborne sterilant
concentration in the spraying compartment could be as low as 30 ppm. Id.
In the cited testimony, however, Dr. Heldman was only responding based on
the assumptions proposed by counsel, which he did not necessarily agree
were “reasonable.” See Ex. 2055, 90:12–93:21 (answering, in response to
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counsel’s questions about the reasonableness of assuming a 100-fold
difference that “I believe it’s possible that it could be that amount”). Patent
Owner has not pointed to any testimony from Dr. Sharon or other evidence
as to the basis for the assumptions that Dr. Heldman was asked to make
during his deposition. Moreover, in contrast to the 30 ppm airborne sterilant
concentration calculated based on counsel’s assumptions, Petitioner
calculates an airborne concentration of 297,000 ppm based on the testimony
of Patent Owner’s expert in another related IPR. Pet. Reply 13 (citing Ex.
2061, ¶¶ 14, 18).
Additionally, Patent Owner argues that the FDA Regulations do not
apply to the Scholle system because they only focus on the sterilant
concentration on the interior of the package as opposed to in the air, and
there is no risk in Scholle of H2O2 ever coming into contact with the interior
of the container into which the liquid will be filled. PO Resp. 21–22. Patent
Owner relies upon a) the fact that the bags used for Scholle’s apparatus are
“presterilized,” and b) the fact that Scholle’s filling process involves the
formation of an “overlay arrangement with the inner end of the spout to seal
of the spout and exclude entry of air and other foreign matter.” Id. at 21
(citing Ex. 2056, ¶¶ 35–36, 41; Ex. 2049, 2:15–24). Patent Owner asserts
that the airborne sterilant concentration in the fill zone could be as high as
approximately 500 ppm while still meeting the FDA residual peroxide test.
Id. at 16–17, 27 (citing Ex. 2056, ¶¶ 22–24).
Although Scholle does not specify the sterilant concentration in the
filling compartment, Petitioner counters that “[b]ecause the Scholle system
uses a H2O2 solution to sterilize food packaging material, this regulation
expressly applies to Scholle.” Pet. Reply 11. Petitioner contends that the
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skilled artisan would have found it obvious to minimize the residual sterilant
concentration in the filling compartment as much as possible in view of the
FDA Regulations, which specify that the residual concentration should be
less than 0.5 ppm. Id. at 11–15.
We are not persuaded by Patent Owner’s arguments because, as
discussed above, regardless of whether the presterilized bags are filled in the
manner asserted by Patent Owner, it is undisputed that Scholle’s apparatus is
designed such that the H2O2 concentration in the filling compartment will be
lower than the concentration in the spraying compartment. Tr. 122:12–14.
Moreover, the evidence of record establishes that other prior art aseptic
bottling systems recognized the importance of limiting the concentration of
H2O2 in the filling zone in order to comply with regulatory limits. For
example, ZFL teaches with respect to the Bosch system that: “As for the
admissible residual peroxide in the containers, there is a limit of up to 0.5
ppm only in the U.S. The maximum allowable concentration in the
workplace of 1 ppm for H2O2, in contrast, is an international limit. The
plants are adjusted so as to fall below both thresholds.” Ex. 1010, 297
(emphasis added). Elliot teaches that a “window of operation” for
sterilization can be created by “varying the peroxide dosage/container and
the heated air temperature” in order “to give the maximum allowable
peroxide residual of 0.5 ppm/container.” Ex. 1015, 118. Thus, contrary to
Patent Owner’s arguments with respect to airborne sterilant concentrations,
the prior art recognizes that maintaining a low sterilant concentration in the
filling zone compared to the sterilization zone (i.e., the ratio of sterilant
concentration levels between the two zones) was “result effective.” See PO
Resp. 12 (citing In re Antonie, 559 F.2d 618, 620 (CCPA 1977)).
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Furthermore, even assuming arguendo Patent Owner’s assertion that the
concentration in the filling zone could be as high as 500 ppm and satisfy the
FDA test, we note that the at least about 5 to 1 ratio requirement will still be
satisfied when that concentration is compared to the approximately 300,000
ppm concentration that has been shown to exist in the sterilization zone.
“The outcome of optimizing a result-effective variable may still be
patentable if the claimed ranges are ‘critical’ and ‘produce a new and
unexpected result which is different in kind and not merely in degree from
the results of the prior art.’” In re Applied Materials, Inc., 692 F.3d 1289,
1297 (Fed. Cir. 2012) (citing Aller, 220 F.2d at 456; Antonie, 559 F.2d at
620)). Here, Patent Owner has not offered any credible evidence of
criticality or unexpected results associated with the claimed ratio. The ’435
patent itself does not mention anything about maintaining a particular ratio
of sterilant concentration levels other than in the claims. Accordingly,
“[n]othing [of record] indicates that the optimization of the variables [i.e.,
the sterilant concentration levels] was anything other than the exercise of
ordinary skill in the art.” Id.
In addition to the 5 to 1 sterilant concentration ratio requirement,
Petitioner has met its burden of showing that each of the other recited claim
elements are taught or suggested by the prior art references relied upon for
this challenge, and that there would have been a reason for the skilled artisan
to combine the references to arrive at the claimed invention as a whole. See
Pet. 19–38. We, therefore, determine that a preponderance of the evidence
establishes the obviousness of independent claims 1, 4, 17, and 33 based on
the teachings of Scholle in view of Chambers, the FDA Regulations,
Biewendt, Kelbrick, Elliott, Akai, and Kodera. Additionally, we have
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considered the evidence and arguments presented by Petitioner with respect
to dependent claims 2, 3, 5–10, 14, 16, 18–21, 25, 27, 29, 32, and 34–36,
and determine that Petitioner has also proven the obviousness of those
claims by a preponderance of the evidence based on the same combination
of references. See Pet. 23–28, 32–35, and 38. As noted above, Patent
Owner has not separately argued these dependent claims.
2. Biewendt in view of the FDA Regulations, Buchner, ZFL,
Scholle, Kelbrick, Akai, Kodera, and Elliott
For the second obviousness challenge instituted in this proceeding,
Petitioner relies upon the Bosch system described in the Biewendt reference
(Ex. 1024), as well as in Buchner (Ex. 1011) and ZFL (Ex. 1010), in
combination with other references considered in the first challenge.
Petitioner asserts that the apparatus described in Biewendt includes a “bottle
sterilization machine,” an “aseptic filling machine,” and an “aseptic sealing
machine,” which define a “plurality of zones” as required by the claims.
Pet. 40 (citing Ex. 1024, Fig. 1). Moreover, to the extent partitions are
required in order to create the claimed “zones,” Petitioner argues that it
would have been obvious to provide the apparatus described in Biewendt
with the partitions of Scholle’s apparatus in order to provide the advantages
of (1) reducing or eliminating the transfer of H2O2 from a sterilization zone
to a filling zone, and/or (2) preventing contamination in the various
sterilization zones. Id. at 40, 45 (citing Ex. 1005, 6:25–43).
Petitioner asserts that the 5 to 1 sterilant ratio requirement is satisfied
based on Beiwendt’s teaching that bottles “are sprayed with hydrogen
peroxide (H2O2),” which is stored at a “minimum 33% H2O2”
concentration, and that “[t]esting with Merckoquant 10 001 testing strips did
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not show any proof of contamination with H2O2 residue in filled UHT milk
bottles.” Pet. 41 (citing Ex. 1024, 5, 11, 18). Petitioner asserts that using a
“minimum 33% H2O2” solution would result in a concentration of 330,000
ppm being maintained. Id. (citing Ex. 1004, ¶ 100). Based on the accuracy
of Merckoquant test strips at the time of Biewendt, Petitioner asserts that the
skilled artisan would have understood Biewendt to disclose that H2O2
residue on the filled bottles was observed to be 1 ppm or less. Id. at 41–42
(citing Ex. 1004, ¶ 101; Ex. 1012, 4:43–43). Petitioner also asserts that
“[e]ven without Biewendt’s disclosure regarding sterilant concentrations, a
concentration ratio of at least about 5 to 1 between the applied and residual
sterilant levels would have been obvious in view of Chambers and/or the
FDA Regulations.” Id. at 42.
Patent Owner contends that because the system of Biewendt is not
maintained at a pressure above atmospheric, Biewendt does not disclose a
“sterilization tunnel for surrounding a plurality of containers with
pressurized gas,” as required by each of the challenged independent claims.
PO Resp. 28–34 (citing Ex. 2056 at ¶¶ 14, 20, 51, 55–56; Ex. 2055 at 146–
148). In particular, Patent Owner asserts that the aseptic tunnel of Biewendt
is kept at a pressure 20 Pa above atmospheric while the bottle sterilization
machine appears to be kept at ambient or at a slightly negative pressure. Id.
at 30 (citing Ex. 2056, ¶ 55; Ex. 1024 at 18). Patent Owner draws this
conclusion based on Biewendt’s description of the bottle sterilization
machine as being a “clean room” that is isolated from the aseptic tunnel
through an aseptic lock, and that the mixture of H2O2 and warm air is
“suctioned off through the cover plate openings and separated again in
catalysts located outside the clean room.” Id. at 31–32 (citing Ex. 1024, 5).
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We are unpersuaded by this argument. As an initial matter, Patent
Owner does not dispute that at least the aseptic tunnel portion of Biewendt’s
apparatus (considered part of the claimed sterilization tunnel) is kept
pressurized. The claims, on their face, do not require the entirety of the
sterilization tunnel be kept above atmospheric pressure. Moreover, even if
the claims were interpreted to require all “zones” in the sterilization tunnel
be kept above atmospheric pressure, Biewendt’s apparatus still satisfies that
requirement based on the disclosure that hot sterile air is blown into the
sterilizing machine to activate the H2O2 and dry the bottles, in a manner
similar to disclosure in the ’435 patent. See Pet. 16 (citing Ex. 1024, 17–18;
Ex. 1035, 154:21–155:25; Ex. 1001, 10:3–5). Contrary to Patent Owner’s
arguments, we credit Dr. Heldman’s testimony that a “clean room” would
have been kept above atmospheric pressure. Ex. 2055, 148:9–14, 150:11–
151:8. We further note that Buchner and ZFL, which also describe the
Bosch system, both disclose that the entire plant (i.e., the fully enclosed
system) is subject to a “slight overpressure.” Ex. 1010, 298; Ex. 1011, 27.
A preponderance of the evidence therefore supports the conclusion that the
Bosch system, as described by Biewendt, Buchner, and ZFL, includes a
“sterilization tunnel for surrounding a plurality of containers with
pressurized gas.”
We are also unpersuaded by Patent Owner’s argument that, even
assuming the sterilization machine in Biewendt is pressurized, “it would be
apparent to a [person of ordinary skill in the art] that the concentration of
airborne sterilant in the sterilization machine would fall by orders of
magnitude as between the tank and the air of the sterilization zone of the
Biewendt system.” PO Resp. 35. For reasons similar to those discussed
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above with respect to the Scholle apparatus, the evidence supports the
finding that the 33% H2O2 solution utilized in Biewendt would result in a
sterilant concentration close to 330,000 ppm in the liquid phase at least at
some point after it is sprayed into the sterilization machine. See Ex. 1004, ¶
99. Specifically, Biewendt discloses that “[t]he effectiveness of this
sterilization method is on the one hand based on an optimally fine, even
dispersion of the H2O2 on the surface of the bottle, but in particular on the
drying effect of said H2O2 with at least 80 °C hot air.” Ex. 1024, 18
(emphasis added). Furthermore, in order to comply with the FDA
Regulations (Ex. 1013), the skilled artisan would have had an incentive to
ensure that the residual sterilant concentration on the bottle surfaces in the
fill zone after drying is minimized as much as possible so that the 5 to 1 ratio
requirement is satisfied. This is also reflected in Biewendt’s teaching that
testing with the Merckoquant 10 001 testing strips (accurate to 1 ppm) did
not show any contamination with H2O2 residue in the filled bottles. Ex.
1024, 18; Ex. 1012, 4:43–43.
Additionally, even if airborne concentrations were taken into account,
we are not persuaded by Patent Owner’s contention that the airborne
sterilant concentration ratio would be on the order of 1 to 1. PO Resp. 36.
Patent Owner bases this conclusion on the fact that a) “Dr. Heldman . . .
ultimately agreed that the airborne sterilant concentration in the sterilization
zone of Biewendt could be .0035 parts per hundred, or 35 parts per million,”
and b) Dr. Sharon’s explanation concerning the potential for the airborne
sterilant concentration in the fill zone being as high as 500 ppm. Id. at 35–
36 (citing Ex. 2055, 91:24–92:15, 98:7–9). As discussed above, however,
the cited testimony was only based on certain assumptions proposed by
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counsel during questioning regarding the flow rate of sterile air in the
sterilization chamber. Dr. Heldman did not necessarily agree that those
assumptions were “reasonable,” but rather only indicated it was “possible.”
Id. Moreover, contrary to Patent Owner’s characterization, Dr. Heldman did
not testify about the reasonableness of assuming an additional 100-fold
decrease in sterilant concentration between the time it is taken from the tank
and put through the atomizer. Id. Nor has Patent Owner offered any
credible evidence supporting those assumptions.
Finally, we are unpersuaded by Patent Owner’s argument that the
skilled artisan would not have reasonably expected that Biewendt and
Scholle could be combined because Biewendt does not disclose sufficient
information “to construct the aseptic bottling apparatus disclosed therein”
and meet FDA requirements. PO Resp. 38. Patent Owner also argues
against a reasonable expectation of success because “many manufacturers
failed in their attempts to develop FDA-compliant aseptic filling processes.”
Id. at 39. We agree with Petitioner that the claims do not require an “FDA-
compliant aseptic filling process.” Pet. Reply 19. See Allergan, Inc. v.
Sandoz, Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013) (“[T]he person of
ordinary skilled need only have a reasonable expectation of success of
developing the claimed invention.”). Patent Owner has not offered any
persuasive evidence that failure by others to develop an FDA-compliant
process was solved by the 5 to 1 sterilant concentration ratio or any other
feature recited in the claims of the ’435 patent. See Ashland Oil, Inc. v.
Delta Resins & Refractories, Inc., 776 F.2d 281, 305 n.42 (Fed. Cir. 1985)
(“For secondary considerations to have probative value, the decision maker
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must determine whether there is a nexus between the merits of the claimed
invention and the secondary considerations.”).
In addition to the pressurized sterilization tunnel and the 5 to 1
sterilant concentration ratio requirements, Petitioner has met its burden of
showing that each of the other recited claim elements are taught or suggested
by the prior art references relied upon for this challenge, and that there
would have been a reason for the skilled artisan to combine the references to
arrive at the claimed invention as a whole. See Pet. 39–58. We, therefore,
determine that a preponderance of the evidence establishes the obviousness
of independent claims 1, 4, 17, and 33 based on the teachings of Biewendt in
view of Chambers, the FDA Regulations, Buchner, ZFL, Scholle, Kelbrick,
Akai, Kodera, and Elliott. Additionally, we have considered the evidence
and arguments presented by Petitioner with respect to dependent claims 2, 3,
5–10, 14, 16, 18–21, 25, 27, 29, 32, and 34–36, and determine that Petitioner
has also proven the obviousness of those claims by a preponderance of the
evidence based on the same combination of references. See Pet. 43–48, 53–
56, and 58. As noted above, Patent Owner has not separately argued these
dependent claims.

III. PETITIONER’S MOTION TO EXCLUDE EVIDENCE
Petitioner moves to exclude the following documents: Ex. 2036 (the
Spinak Transcript, Ex. 2037 (the Oxford Declaration), Ex. 2038 (the Gehl
Complaint), Exs. 2043, 2051 (the Buchner Declarations), and Exs. 2056,
2065 (the Sharon Declarations). Paper 75. Because we do not rely on
Exhibits 2036, 2037, 2038, 2043, 2051, and 2065 in this Final Written
Decision, we dismiss Petitioner’s Motion to exclude those exhibits as moot.
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Petitioner argues that the Sharon Declaration submitted in this
proceeding (Ex. 2056) should be excluded because Dr. Sharon is not a
qualified expert, and it fails to satisfy the requirements of FRE 703 and 37
C.F.R. § 42.65, requiring the disclosure of the bases for his opinions. Paper
75, 12–15. Specifically, Petitioner contends that “Dr. Sharon admits that he
has no experience in microbiology, sterilization, food science, or machine
design for aseptic food processing.” Id. at 13. Petitioner also contends that
“the foundations for Dr. Sharon’s conclusions—specifically the tests used to
reach such conclusions—are not disclosed, and Dr. Sharon . . . admits that
he does not know how such tests would be conducted.” Id. at 15. We
determine that Petitioner’s arguments more appropriately go to the weight
Dr. Sharon’s testimony should be given rather than the admissibility of his
declaration. On that basis, we deny Petitioner’s Motion to exclude Ex. 2056.

IV. PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
Patent Owner moves to exclude Exhibits 1042–1044. Paper 73.
Because we do not rely on those exhibits in this Final Written Decision, we
dismiss Patent Owner’s Motion to Exclude as moot.

V. PETITIONER’S MOTIONS TO SEAL
Petitioner has filed a motion to seal Exhibits 1033, 1042, 1043, and
1044, which Petitioner asserts “reveal confidential business information
belonging to Petitioner, including information about the terms of Petitioner’s
relationship with its supplier, and about Petitioner’s production facilities and
capabilities.” Paper 62, 1. Petitioner has also filed a motion to seal the
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confidential version of Patent Owner’s Response (Paper 57)15 and Exhibit
2063 for similar reasons. Paper 65, 1. Patent Owner does not oppose either
motion to seal.
The record for an inter partes review shall be made available to the
public, except as otherwise ordered, and a document filed with a motion to
seal shall be treated as sealed until the motion is decided. 35 U.S.C.
§ 316(a)(1); 37 C.F.R. § 42.14. The standard for granting a motion to seal is
“good cause.” 37 C.F.R. § 42.54. There is a strong public policy that favors
making information filed in inter partes review proceedings open to the
public. See Garmin Int’l v. Cuozzo Speed Techs., LLC, Case IPR2012-
00001, slip op. at 1-2 (PTAB Mar. 14, 2013) (Paper 34) (discussing the
standards applied to motions to seal). The moving party bears the burden of
showing that the relief requested should be granted. 37 C.F.R. § 42.20(c).
That includes showing that the information is truly confidential, and that
such confidentiality outweighs the strong public interest in having an open
record. See Garmin, slip op. at 3.
Having considered the documents at issue, we are persuaded that
Petitioner has demonstrated “good cause” for keeping them under seal
during the course of this proceeding, as they relate to confidential business
information of Petitioner. We did not rely upon any of the confidential
information in our Final Written Decision. We note, however, that
confidential information subject to a protective order will ordinarily become
public 45 days after this final judgment unless the parties file a motion to
expunge the information prior to the information becoming public. See

15 Patent Owner has filed a redacted version of its Patent Owner Response.
Paper 66.
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Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48760–61 (Aug. 14,
2012); 37 C.F.R. § 42.56. In accordance with prior practice, the parties may
also seek to preserve the record and keep any confidential documents sealed
until the outcome of any appeal of this decision. See Nestlé USA, Inc. v.
Steuben Foods, Inc., Case IPR2014-01235, Order Granting Request to
Preserve Record Pending Appeal (Paper 68) (PTAB Feb. 9, 2016).

VI. CONCLUSION
We conclude that Petitioner has demonstrated by a preponderance of
the evidence that claim 1–10, 14, 16–21, 25, 27, 29, and 32–36 are rendered
obvious under 35 U.S.C. § 103 by a) Scholle in view of Chambers, the FDA
Regulations, Biewendt, Kelbrick, Elliott, Akai, and Kodera; and b) Biewendt
in view of Chambers, the FDA Regulations, Buchner, ZFL, Scholle,
Kelbrick, Akai, Kodera, and Elliott.

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36
VII. ORDER
Accordingly, it is
ORDERED that claims 1–10, 14, 16–21, 25, 27, 29, and 32–36 of U.S.
Patent 6,475,435 B1are held to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude Evidence
(Paper 75) is dismissed as moot with respect to Exhibits 2036, 2037, 2038,
2043, 2051, and 2065; and denied with respect to Exhibit 2056;
FURTHER ORDERED that Patent Owner’s Motion to Exclude Evidence
(Paper 73) is dismissed as moot;
FURTHER ORDERED that Petitioner’s Motion to Seal Exhibits 1033,
1042, 1043, and 1044 (Paper 62), and Petitioner’s Motion to Seal the
confidential version of the Patent Owner Response and Exhibit 2063 (Paper
65) are granted;
FURTHER ORDERED that because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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PETITIONER:
Thomas H. Jenkins
tom.jenkins@finnegan.com

Virginia L. Carron
virginia.carron@finnegan.com

Tyler M. Akagi
tyler.akagi@finnegan.com

PATENT OWNER:

Greg H. Gardella
cpdocketgardella@oblon.com

Scott A. McKewon
cpdocketmckeown@oblon.com

Ruby J. Natnithithadha
cpdocketrjn@oblon.com