STEUBEN FOODS INCORPORATED et al.

Patent Trials and Appeals Board

Jul 21, 2021

2021002746 (P.T.A.B. Jul. 21, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
90/013,458 02/24/2015 US 6475435 P50281US01 6578
159853 7590 07/21/2021
Steuben Foods, Inc.
155-04 Liberty Avenue
Jamaica, NY 11433
EXAMINER
DAWSON, GLENN K
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
07/21/2021 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
90/012,135 03/09/2012 6475435 P50281US00 3105
159853 7590 07/21/2021
Steuben Foods, Inc.
155-04 Liberty Avenue
Jamaica, NY 11433
EXAMINER
DAWSON, GLENN K
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
07/21/2021 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
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UNITED STATES PATENT AND TRADEMARK
OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte
Steuben Foods, Inc.
Patent Owner and Appellant
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Technology Center 3900
Before
JAMES T. MOORE, JEREMY M. PLENZLER, and
CHRISTOPHER G. PAULRAJ,
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Administrative Patent Judges.
PLENZLER,
Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. §§ 134(b) and 306, Steuben Foods, Inc.
(Appellant) appeals from the final rejection of claim 37. We have
jurisdiction under 35 U.S.C. § 6(b). An oral hearing was held on May
19, 2021, and a transcript (“Tr.”) of that hearing is included in the
record.
We
affirm.
CLAIMED SUBJECT MATTER
The claims are directed to an aseptic packaging sterilization
apparatus. Claim 37, reproduced below, is the sole claim on appeal:
37.Apparatus comprising:
means for providing a plurality of containers in a
sterilization tunnel;
means for providing a plurali ty of steri lant
concentration zones within the sterilization tunnel wherein
the sterilant concentration levels of the plurality of sterilant
concentration zones are maintained at a ratio of at least
about 5 to 1; and
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means for providing a plurality of gas flow rates
within the sterilization tunnel.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Scholle US 4,417,607 Nov. 29,
1983
Kelbrick US 5,534,222 July 9, 1996
Shibauchi EP 0342690 A1 Nov. 23,
1989
N. Buchner Aseptic Filling of Glass and
Plastic Containers, 295–98,
ZFL Magazine (“ZFL”)
1989
James V.
Chambers & Philip
E. Nelson
Principles of Aseptic
Processing and Packaging,
The Food Processors
Institute (2d ed. 1993)
(“Chambers”)
1993
21 C.F.R. §
178.1005
(“FDA Regulations”) Apr. 1, 1996
REJECTION
Claim 37 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over ZFL, Kelbrick, FDA Regulations, Chambers,
Scholle, and Shibauchi.
OPINION
Claim Construction
Claim 37 is the sole claim at issue in this appeal, and includes
three mean-plus-function limitations, which are each addressed
below. U.S. Patent 6,475,435 (“the ’435 patent”) is expired. “In a
reexamination proceeding involving claims of an expired patent, claim
construction pursuant to the principle set forth by the court in Phillips
v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed.
Cir. 2005) . . . should be applied.” MPEP § 2258(I)(G).
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Cir. 2005) . . . should be applied.” MPEP § 2258(I)(G).
There is no dispute that the limitations of claim 37 invoke 35
U.S.C. § 112, paragraph six. A means-plus-function limitation “shall
be construed to cover the corresponding structure, material, or acts
described in the specification and equivalents thereof.” 35 U.S.C. §
112, paragraph six. “[T]he PTO [i]s required by statute to look to [the]
specification and construe the ‘means’ language recited in the . . .
claim . . . as limited to the corresponding structure disclosed in the
specification and equivalents thereof.” In re Donaldson, 16 F.3d
1189, 1194–95 (Fed. Cir. 1994) (en banc).
“[T]he sixth paragraph of section 112 does not exempt an
applicant from the requirements of the first two paragraphs of that
section,” meaning that “one is still subject to the requirement that a
claim ‘particularly point out and distinctly claim.’” In re Donaldson, 16
F.3d at 1195. “[I]f one employs means-plus-function language in a
claim, one must set forth in the specification an adequate disclosure
showing what is meant by that language,” and “[i]f an applicant fails to
set forth an adequate disclosure, the applicant has in effect failed to
particularly point out and distinctly claim the invention as required by
the second paragraph of section 112.” Id.
As the Examiner notes, “reexamination guidelines prevent an
examiner from analyzing an original patent claim under [paragraphs
one and two of 35 U.S.C. §] 112.” Final Act. 4. For purposes of this
decision, therefore, we assume that the disclosure of the ’435 patent
complies with the requirements of 35 U.S.C. § 112, paragraph one,
and that the claim complies with the requirements of 35 U.S.C. § 112,
paragraph two.
“means for providing a plurality of containers in a sterilization tunnel”
There is no dispute that the structure disclosed in Appellant’s
Specification corresponding to this limitation is a conveying system.
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See Final Act. 12; Ans. 11; Appeal Br. 22–23; Tr. 22:19–21.
“means for providing a plurality of sterilant concentration zones . . .”
The Examiner finds that Appellant’s Specification discloses
“partitions (deemed to be 130a, 130b and 130c), and hot sterile air
sources-(deemed to be 140, 142, 144, 146)” as the structure
corresponding to the “means for providing a plurality of sterilant
concentration zones within the sterilization tunnel wherein the
sterilant concentration levels of the plurality of sterilant concentration
zones are maintained at a ratio of at least about 5 to 1.” Final Act.
13; Ans. 12.
Appellant does not dispute the Examiner’s characterization of
the structure required by this means clause. Appeal Br. 7; Tr.
3:17–24. Indeed, Appellant explains that “[t]he ’435 patent
specification . . . describes the various zones by stating that they are
formed, in part, by partitions.” Appeal Br. 7 (citing ’435 patent
9:9–24). Appellant notes that “[t]he ’435 patent further explains that
the various zones are kept at different air pressures” and “[h]aving
different air pressures in the zones within the sterilization tunnel
ensures that the air will flow away from the filling zone and through
the less critical zones of the sterilization tunnel—while at the same
time ensuring that contaminants do not enter the filling zone.” Id. at 8
(citing ’435 patent 9:41–50).
The Specification describes the structures for the partitions and
the sterilant air sources at a very high level of generality. The
partitions, for example, are only depicted schematically, and
described as including baffle plates with cut-outs that allow for
passage of bottles. ’435 patent 8:62–9:18. The sterilant air sources
are also only depicted schematically and are simply described as
conduits. Id. at 9:19–24. At oral hearing, Appellant acknowledged
that, other than the generic structure noted above, there is no
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particular structure associated with the partitions or sterile air
sources. Tr. 5:6–16; see also id. at 7:11–15 (when asked if there is
“any specific structure from [the] specification . . . for the partition and
the sterile air source,” replying “[n]o, it is a general – it’s certainly a
general structure”).
Appellant additionally contends, however, that the sterilant,
itself, is required. Appeal Br. 7. Appellant contends that the
recitation of “sterilant concentration levels” in the claim requires a
mass of airborne sterilant in one zone that is at least five times that in
another zone.
As acknowledged by Appellant, and noted above, the partitions
and sterile air sources cooperate to provide different pressure in the
zones. ’435 patent 9:25–50; see also Tr. 19:4–6 (“it’s partitions and
it’s zones, partitions create the zones, and it’s over-pressure”).
Appellant acknowledged that sterilant is only introduced in fourth
sterilization zone 165, which is actually the first zone in the
sterilization process. Tr. 14:15–23. Appellant also acknowledged
that the sterilant in first, second, and third sterilization zones 164,
166, 172 is simply the result of being blown into that zone from an
upstream zone in the system. Id. at 14:23–15:1.
For purposes of this decision, we accept Appellant’s contention
that “sterilant concentration” refers to an airborne concentration of
sterilant. We do not agree, however, that the claim requires a mass
of airborne sterilant. Rather, the “means for providing a plurality of
sterilant concentration zones . . .” in claim 37 requires partitions and
sterilant air sources that perform the function of maintaining “the
sterilant concentration levels of the plurality of sterilant concentration
zones . . . at a ratio of at least about 5 to 1.” That is, the only
structure required by this means clause is partitions and sterilant air
sources. This structure performs the function of maintaining the
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recited ratio of the mass of airborne sterilant.
Because no particular structures for the partitions and sterilant
air sources are disclosed in the Specification, we find, for purposes of
this decision, that any generic partition and sterilant air source that
can perform the recited function qualifies as the corresponding
structure, or at least equivalent structure to the partitions and sterilant
air sources discussed in the Specification.
“means for providing a plurality of gas flow rates . . .”
The Examiner finds that Appellant’s Specification discloses
“[t]he corresponding structure for performing the function of ‘providing
a plurality of gas flow rates within the sterilization tunnel’ is a series of
inlet and exhaust conduits, and a control system with air pressure
and flow sensors.” Final Act. 14; Ans. 13.
Appellant does not dispute that the structure identified by the
Examiner is the appropriate corresponding structure, but responds
that “the rejection still does not identify where those structures are
found in the ’435 patent specification.” Appeal Br. 23. Appellant
contends that “it is unclear in the rejection what, for example, the
Examiner contends to be included in the control system.” Id. at
23–24. Notably, Appellant does not allege any particular structure is
required for its control system either.
The Examiner finds that “[t]he structure of the control system is
not specifically disclosed in the ’435 specification but rather what is
disclosed is what the control system does.” Ans. 19. Appellant does
not dispute this finding. The Examiner explains that “the control
system needs to have various sensors which present operating data
which is compared to desired operating parameters, and it would
possess the ability to control and/or adjust operating conditions.” Id.
The Examiner additionally explains that “[a]ny POSITA would have
been aware of the notion” because “a sophisticated aseptic system[,
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such] as the prior art[,] requires very specific operating parameters for
each and every parameter needed to ensure sterility and aseptic
packaging of foodstuffs.” Id. Appellant also does not dispute this
understanding.
We agree with the Examiner. Indeed, Appellant acknowledged
that “the structure that meets that requirement for the gas flow rates
is going to be the inlet and exhaust conduits, the control system, and
the plurality of flow sensors.” Tr. 20:8–11. When asked where any
details are for the control system, other than a general reference to
“control system 550,” Appellant responded that “we don’t believe it
needs to have something specific, it just needs to have a control
system” because “[t]his is a well-known term in the art where one of
ordinary skill would know what structure that is.” Id. at 20:15–21.
Appellant acknowledged that any of the systems in the prior art
providing a flow rate and having sensors will have this type of control
system. Id. at 21:7–11.
Although Appellant appears to dispute the Examiner’s findings,
there is no actual dispute that the structure performing the function of
“providing a plurality of gas flow rates within the sterilization tunnel” is
the inlet and exhaust conduits, the control system, and the plurality of
flow sensors. Tr. 20:8–11. The Specification discloses inlet and
outlet conduits through which sterilant gas enters and exits the
multiple sterilization zones of the sterilization tunnel. ’435 patent
10:3–31; Fig. 3. For example, sterile gas enters and exits first
sterilization zone 164 through conduits 148 and exhaust ports 153,
respectively. Id. at 10:3–7, 10:11–14. The Specification further
discloses a control system 550 for monitoring the air pressure and
flow rate of the sterile heated air “to ensure that an adequate flow of
the hot sterile air is maintained” in various parts of the sterilization
tunnel. See, e.g., id. at 7:4–8, 7:34–37, 10:42–45. Control system
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550 gathers information from monitoring devices, including “[a]
plurality of flow sensors to ensure that the airflow rate of the sterile air
entering the sterilization tunnel 90 is correct.” Id. at 14:43–51,
15:43–45.
Because no particular structures are disclosed for the inlet and
exhaust conduits, the control system, and the plurality of flow
sensors, we find, for purposes of this decision, that any inlet and
exhaust conduits, control system, and flow sensors for performing the
recited function qualify as the corresponding structure, or at least
equivalent structure.
Rejection
“means for providing a plurality of containers in a sterilization tunnel”
The Examiner finds that ZFL teaches “means for providing a
plurality of containers in a sterilization tunnel.” Final Act. 5. We
agree with the Examiner, and Appellant does not dispute this finding.
See Appeal Br., generally.
“means for providing a plurality of sterilant concentration zones . . .”
The Examiner finds that ZFL teaches “a plurality of zones within
the tunnel (rinser, sterilizing, drying, filling, closing/capping).” Final
Act. 5. The Examiner finds that Scholle and Shibauchi teach the
partitions and sterilant air sources. Id. at 5–6. The Examiner
additionally finds that “KELBRICK and SCHOLLE teach different air
pressures in the different zones” and “[t]hese pressure differences
and partitions would act to cause the different zones to have different
sterilant concentrations.” Id. The Examiner finds that “SHIBAUCHI
teaches of using a dividing plate partition 27 and differential air
pressures to prevent airborne hydrogen peroxide sterilant from
migrating from the sterilization zone to the fill and pack zone” and that
this differential pressure “prevent[s] air containing atomized hydrogen
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peroxide (airborne sterilant) in the sterilization zone from leaking into
the fill and pack zone and polluting the food product with the
sterilization agent.” Id. at 6.
Appellant does not dispute these findings. Rather, Appellant
contends that the references do not expressly discuss maintaining a
ratio of at least 5 to 1 of the airborne sterilant. See, e.g., Appeal Br.
11–12, 19. Appellant also alleges that “the Office Action fails to
adequately explain whether the alleged ‘equivalent’ structure to the
general structure identified in the ’435 patent specification (for that
claimed function) performs the ‘identical’ function.” Id. at 25–26.
The Examiner has the better position. We agree with the
Examiner’s undisputed findings regarding the partitions and sterilant
air sources taught by the references noted above. There is no
meaningful difference in structure between those partitions and
sterilant air sources and what Appellant has disclosed in its
Specification. At oral hearing, Appellant acknowledged that “to
maintain or to control what those [sterilant concentration] values are”
it relies on what “a POSITA would-- and certainly an engineer would
know.” Tr. 17:6–14. Appellant faults the Examiner’s rejection for
lacking sufficient detail when that same detail is lacking from the ’435
patent.
We agree with the Examiner that the partitions and sterilant air
sources taught by the references noted above perform the function of
maintaining “the sterilant concentration levels of the plurality of
sterilant concentration zones . . . at a ratio of at least about 5 to 1” as
recited in the claim. We do not find error in the Examiner’s rejection
for providing the same level of detail taught in the references as that
disclosed in the ’435 patent, particularly where the claim is written in
means-plus-function format where the structure is limited to what is
disclosed in the Specification and its equivalents.
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For at least these reasons, we are not apprised of Examiner
error in the findings related to the “means for providing a plurality of
sterilant concentration zones.”
Moreover, even if the claim required some mass of airborne
sterilant that is at least five times greater in one zone than another,
we note that in the related appeal, the Federal Circuit found that
“Scholle discloses that the specific concentration of hydrogen
peroxide in the spraying zone is around 300,000 ppm.” Steuben
Foods, Inc. v. Nestle USA, Inc., 884 F.3d 1352, 1357 (Fed. Cir.
2018). Scholle explains that “the spray head 80 continuously
operates to supply a mist of hydrogen peroxide to the spraying
chamber 70, during the operation of the apparatus 10.” Scholle,
5:45–48. As the Examiner finds, and Appellant does not dispute, for
example, “THE FDA REGULATIONS require <0.5 ppm residual
hydrogen peroxide on the bottles after sterilization.” Final Act. 5.
Appellant acknowledged that it is the over-pressurization
between successive zones that severely inhibits the sterilant from
one zone being blown into another. Tr. 14:25–15:9. Appellant also
acknowledged that the cited references have the same over-
pressurization scheme. See, e.g., id. at 15:13–17. Because the cited
references have the same structure with essentially the same initial
spray concentration as the 35% referenced in the ’435 patent (see
’435 patent, 5:2–4), it is reasonable to conclude that the cited
teachings would function to provide the 5 to 1 ratio recited in the
claim. Indeed, the arrangement in ’435 patent is even described as
providing a ratio of 10,000 to 1 (1000 ppm in fourth sterilization zone
165 to 0.1 ppm in third sterilization zone 172), which is 2,000 times
that recited in the claim.
“[I]f the prior art reference teaches the identical structure or acts
but is silent about performing the claimed function, a reasonable
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presumption is that the prior art structure inherently performs the
same function.” MPEP § 2182. For the reasons explained above,
the Examiner has provided a reasonable basis to believe that the
prior art structure would perform the recited function. Appellant does
not rebut that determination in any persuasive manner.
We also agree with the Examiner that the airborne sterilant
concentration ratio is a result-effective variable, and that the recited
ratio would have been obvious as a matter of routine optimization.
Final Act. 6–7; Ans. 6. In response, Appellant again faults the
Examiner for providing the same level of detail in the teachings of the
prior art as that in the ’435 patent. See, e.g., Appeal Br. 11 (“the
rejection does not cite a single reference that suggests that
maintaining a ratio of airborne sterilant concentration between two
zones in a sterilization tunnel was known, let alone known as a result-
effective parameter.”).
“[W]here the general conditions of a claim are disclosed in the
prior art, it is not inventive to discover the optimum or workable
ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456
(CCPA 1955). There is no discussion of maintaining a particular ratio
in the ’435 patent. The Examiner even notes that the ’435 patent’s
sole inventor “Mr. Taggart . . . testified that he did not come up with
the 5:1 ratio,” which Appellant does not dispute. Ans. 6. There can
be no reasonable dispute, based on the findings discussed above
(e.g., Scholle’s 300,000 ppm sterilant mist and the FDA requirement
of less than 0.5 ppm residual sterilant), that 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.”
To the extent Appellant asserts that the state of sterilant makes a
difference (residual versus airborne), we note that Appellant
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acknowledged that the filling zone airborne sterilant concentration
would need to be limited to meet the FDA residual sterilant
requirements. See Tr. 14:7–12 (noting a limitation of “up to 500 parts
per million in the air”). Indeed, as discussed above, the reason for
pressure differentials between the zones in the ’435 patent and the
prior art is to inhibit downstream airborne transmission of sterilant.
“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; In
re Antonie, 559 F.2d 618, 620 (CCPA 1977)). Here, Patent Owner
has not offered any credible evidence of criticality or unexpected
results associated with the claimed ratio. As noted above, the ’435
patent, itself, does not even mention maintaining a particular ratio of
sterilant concentration levels.
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.
“means for providing a plurality of gas flow rates . . .”
Appellant similarly fails to identify error in the Examiner’s
findings related to the “means for providing a plurality of gas flow
rates.” Appellant notes the Examiner’s finding that “SHIBAUCHI has
an air current control means . . . ,” but alleges fault in the rejection for
“not properly identify[ing] and lack[ing] clarity as to the function
performed by the ‘air current control means,’” as well as “fail[ing] to
adequately explain why it is the Examiner’s position that the ‘air
current control means’ is equivalent to the structure in the ’435 patent
or necessary to perform the identical function as claimed.” Appeal Br.
26. Again, Appellant does not identify any structure missing from
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Shibauchi. This is understandable because the ’435 patent provides
no structure, other than a general reference to control system 550.
As the Examiner finds, “[t]here is nothing disclosed in the ’435 patent
concerning the control system which would not also be part of every
aseptic production plant in the prior art.” Ans. 20; see also Tr.
20:17–21, 21:7–11.
Again, we do not find error in the Examiner’s rejection for
providing the same level of detail taught in the references as that
disclosed in the ’435 patent, particularly where the claim is written in
means-plus-function format where the structure is limited to that
disclosed in the Specification and its equivalents.
The Rejection’s Rationale
Appellant provides a number of general allegations regarding
the Examiner’s rationale for the proposed combination that do not
apprise us of any particular error in the rejection. For example,
Appellant provides a general allegation of picking and choosing
(Appeal Br. 12) and lack of clarity as to how ZFL can be modified (id.
at 13). These allegations, however, are unpersuasive because they
do not contain any meaningful explanation identifying a particular
error in the Examiner’s rejection.
Appellant also contends that the Examiner has failed to
establish a reasonable expectation of success for the proposed
combination. Id. at 27–35. That, too, is unpersuasive of error.
Appellant alleges, for example, that “the Examiner did not even
attempt to explain how the various identified structures could be
combined.” Appeal Br. 29.
The Examiner, however, finds that ZFL teaches a sterilization
tunnel with a plurality of zones and proposes adding partitions
between the zones and sterilant air sources to provide pressure
differentials as taught by the references noted above. See Final Act.
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5–6. That is, the Examiner combines a very basic set of teachings
among the cited references. It is unclear, based on the record before
us, why the Examiner’s proposed combination would not have a
reasonable expectation of success.
As the Examiner explains (Final Act. 21–22), Appellant’s
additional contentions regarding the enablement of various
references (29–35) are not persuasive, particularly where those same
references discussed by Appellant were previously relied on in the
final written decision (Paper 97) in IPR2015-00195, which was
affirmed by the Court of Appeals for the Federal Circuit. Steuben
Foods, Inc. v. Nestle USA, Inc., 884 F.3d 1352 (Fed. Cir. 2018).
Moreover, Appellant’s contentions are particularly unpersuasive
because the ’435 patent, itself, relies on relies on what “a POSITA
would--and certainly an engineer would know” to provide written
description and enablement support for its general disclosure. Tr.
17:6–14. That is, because we assume that the general disclosure of
the ’435 patent complies with the requirements of 35 U.S.C. § 112,
paragraph 1, as noted above, we are also not persuaded by
Appellant’s contentions regarding lack of enablement of the cited
references for allegedly providing similarly general disclosure.
Summary
For at least the reasons set forth above, we are not apprised of
error in the Examiner’s decision to reject claim 37.
Estoppel
In addition to the reasons for affirming the Examiner’s rejection
explained above, we also note the estoppel provisions provided by
our rules.
As Appellant acknowledges (Appeal Br. 2), the ’435 patent was
involved in an inter partes review that resulted in a final written
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decision (IPR2015-00195, Paper 97), finding claims 1–10, 14, 16–21,
25, 27, 29, and 32–36 to be unpatentable, which was affirmed by the
Court of Appeals for the Federal Circuit. Steuben Foods, Inc. v.
Nestle USA, Inc., 884 F.3d 1352 (Fed. Cir. 2018).
Our rules explain that “[a] patent . . . owner is precluded from
taking action inconsistent with the adverse judgment.” 37 C.F.R.
§ 42.73(d)(3). More specifically, Appellant is estopped from
“obtaining in any patent: (i) A claim that is not patentably distinct from
a finally refused or canceled claim.” 37 C.F.R. § 42.73(d)(3)(i). A
result of this reexamination proceeding “confirming [the] claim of the
patent” (35 U.S.C. § 307) is obtaining a claim as set forth in 37 C.F.R.
§ 42.73.
The ’435 patent’s failure to provide any specificity for the
conveying system (“means for providing a plurality of containers in a
sterilization tunnel”), partitions and sterilant air sources (“means for
providing a plurality of sterilant concentration zones . . .”), and the
inlet and exhaust conduits, control system, and flow sensors (“means
for providing a plurality of gas flow rates . . .”) results in claim 37
being patentably indistinct from those found unpatentable in
IPR2015-00195. Further, many of the findings from that proceeding
are binding in this proceeding as well.
For example, claims 1, 2, 5, and 6 of the ’435 patent recite:
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.
2. The apparatus of claim 1, wherein said plurality
of zones have different gas flow rates.
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Patent 6,475,435 B1
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5. The apparatus of claim 3, further comprising at
least one partition forming the plurality of sterilant
concentration zones within the sterilization tunnel.
6. The apparatus of claim 3, wherein the gas is
steri le air.
’435 patent 16:46–54, 17:8–11. As seen above, claims 1, 2, 5, and 6
require generally the same structure required by claim 37. Although
a control system is not specifically recited in this set of claims, that
does not make claim 37 patentably distinct. See Tr. 21:7–11
(agreeing that any of these systems that has these varied flow rates
in zones will have a control system).
As another example, claim 33 of the ’435 patent recites:
33. A method comprising:
providing a sterilization tunnel for surrounding a plurality
of containers with pressurized gas;
introducing sterilant from a sterilant supply source into the
sterilization tunnel;
providing a plurality of sterilant concentration zones within
the ster i l izat ion tunnel wherein the ster i lant
concentration levels of the plurality of sterilant
concentration zones are maintained at a ratio of at
least about 5 to 1;
providing at least one partition for forming said sterilant
concentration zones;
setting the level of sterilant concentration by a control
system;
introducing pressurized gas from at least one gas supply
source into the sterilization tunnel; and
allowing the pressurized gas to escape the sterilization
tunnel.
’435 patent 18:28–46. Although claim 33 is written in the form of a
method, it requires the same structure as that recited in claim 37.
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The difference in claim construction (the “ratio of at least about
5 to 1” being airborne versus on the bottle) does not make claim 37
patentably distinct from claims 1, 2, 5, and 6 or 33 because the
structure recited in those claims is the same as that required by claim
37 and performs the same functions regardless of whether the ratio is
determined based on sterilant that is airborne or on the bottle.
Indeed, Appellant does not rely on any particular disclosure
from the ’435 patent as to how the required structure would operate
to achieve the functions, but, rather, that “a POSITA would-- and
certainly an engineer would know . . . certainly, the pressure
differentials plays a role in it. The amount of sterilant you use will
play a role in it. And these are variables.” Tr. 17:13–17; see also id.
at 10:15–18 (explaining, with respect to the structure recited in claim
37, that “it’s an apparatus claim . . . and it’s capable of doing that . . .
then there might be an argument that if something’s put in there it
could mean that” function of maintaining the airborne sterilant ratio).
That is, based on the claim constructions set forth above, and
in view of the estoppel provisions of our rules, Appellant also could
not obtain claim 37 in this proceeding (i.e., it could not be confirmed)
because it is not patentably distinct from the claims cancelled in
IPR2015-00195. Appellant cannot re-argue issues that have already
been decided in that final decision.
CONCLUSION
The Examiner’s rejection is affirmed.
DECISION SUMMARY
In summary:
Claim
Rejected
35
U.S.C. §
References Affirmed Reversed
Appeal 2021-002746
Reexamination Control 90/012,135 and 90/013,458
Patent 6,475,435 B1
19
37 103 ZFL, Kelbrick,
FDA
Regulations,
Chambers,
Scholle,
Shibauchi
37
REquests for extensions of time
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. §
41.50(f).
affirmed
For Appellant:
STEUBEN FOODS, INC.
155-04 Liberty Avenue
Jamaica, NY 11433
For Third Party Requester:
PILLSBURY WINTHROP SHAW PITTMAN, LLP (NV)
P. O. Box 10500
McClean, VA 22102