`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`GEA PROCESS ENGINEERING, INC.
`Petitioner
`v.
`STEUBEN FOODS, INC.
`Patent Owner
`_______________
`Case IPR2014-00055
`U.S. Patent No. 6,536,188
`_______________
`
`
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`Before RAMA G. ELLURU, BEVERLY M. BUNTING, and
`CARL M. DeFRANCO, Administrative Patent Judges.
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Table of Contents
`
`
`I. It Was Obvious To Add PAA To ZFL’s H2O2 Sterilant ....................................... 1
`A. The Prior Art Promoted The Combined Use Of PAA and H2O2 .................... 1
`B. Blakistone Promotes The Use Of PAA ........................................................... 3
`1. Blakistone Promotes The Consideration Of PAA As A Sterilant For Low-
`Acid Aseptic Packaging Systems ............................................................... 3
`2. PO Misstates The Relative Effectiveness of PAA and H2O2 ..................... 3
`3. A 4 Log Reduction Of B. Cereus Using PAA Would Satisfy The FDA ... 4
`4. Claim 40 and ZFL Are Not Limited To Low-Acid Foods ......................... 5
`C. It Was Obvious To Use PAA In ZFL Even Though PAA Was Not FDA-
`Approved ......................................................................................................... 5
`II. Using PAA And H2O2 In ZFL Would Obviously Result In At Least A 6 Log
`Reduction Of Spore Organisms On The Bottles .................................................. 6
`III. ZFL Anticipated Or Rendered Obvious Claim 40’s 101+ BPM Speed ............... 7
`IV.The Prior Art Enabled The Claimed Use Of PAA In ZFL ................................... 8
`A. The Prior Art Is Enabled Because It Is As Detailed As PO’s Patent
`Regarding The Use Of PAA As A Sterilant .................................................... 9
`B. Modifying ZFL To Use PAA And H2O2 Required Only Routine
`Experimentation With Known Result-Effective Variables ........................... 10
`C. Industry LAASF Systems Routinely Obtained FDA Approval .................... 11
`D. “Claim 40 Is Not Limited To “Low Acid” Products ..................................... 12
`V. Mr. Spinak Is The Only Aseptic Packaging Expert And Confirms The
`Obviousness Of Claim 40 ................................................................................... 13
`VI.Conclusion .......................................................................................................... 15
`
`
`
`Claim 40 was obvious because (I) it was obvious to use peroxyacetic acid
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`(“PAA”) and hydrogen peroxide (H2O2) as ZFL’s sterilant, (II) using PAA and
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`H2O2 would obviously result in “at least a 6 log reduction of spore organisms” on
`
`ZFL’s bottles, (III) ZFL taught or was obviously modified to operate at 101+
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`bottles per minute (“BPM”), (IV) the prior art was enabled because it was as
`
`detailed as PO’s own patent regarding how to use PAA, and (V) Mr. Spinak is the
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`only aseptic packaging expert and confirms that claim 40 is invalid.
`
`I.
`
`It Was Obvious To Add PAA To ZFL’s H2O2 Sterilant
`Claim 40 recites that “the sterilant is [PAA] and [H2O2].” Ex. 1001, claim
`
`40. Contrary to PO’s assertions, adding PAA to ZFL’s H2O2 sterilant was obvious
`
`because (A) the prior art provides explicit reasons to do so, (B) Blakistone (Ex.
`
`2046) promotes the use of PAA as a sterilant, and (C) it was obvious to use PAA
`
`even though PAA was not yet FDA-approved.
`
`A. The Prior Art Promoted The Combined Use Of PAA and H2O2
`It was obvious to add PAA to ZFL’s H2O2 sterilant because the combination
`
`(1) was a well-known alternative to H2O2 alone, and (2) was known to be more
`
`effective than H2O2 alone. Chambers (Ex. 1008), p. 60 (“The most common
`
`sterilants used for aseptic packaging applications worldwide are hydrogen
`
`peroxide, . . . [PAA], . . . or combinations of these methods.”); id. at 65 (“H2O2 …
`
`when combined with [PAA], had an additive sporicidal effect.”); Willhoft (Ex.
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`IPR2014-00055: U.S. Patent No. 6,536,188
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`1019), p. 36-37 (“bottles (both glass and plastic) are sterilized with a mixture of
`
`peroxide and [PAA], known as ‘Oxonia.’”); Ex. 1021, p. 22 (PTO finding that “[i]t
`
`would have been obvious to have used Oxonia to disinfect the bottles as a mere
`
`obvious known alternative to hydrogen peroxide.”); ZFL (Ex. 1020), p. E2; KSR
`
`Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[T]he mere substitution of
`
`one element for another known in the field” to “yield a predictable result” is
`
`obvious.); Smith v. Hayashi, 209 U.S.P.Q. 754, 759 (BPAI 1980) (finding that
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`evidence that two photoconductors were both known in the art “presents strong
`
`evidence of obviousness in substituting one for the other”).
`
`Moreover, it was obvious to add PAA to ZFL’s H2O2 sterilant because PAA
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`was known to be more effective than H2O2 at the low temperatures used to sterilize
`
`ZFL’s plastic bottles:
`
`[A]lternatives [to H2O2] are being sought because [H2O2] is efficacious at
`temperatures too high for some of the packaging materials in use today.
`[PAA] has been found to be sporicidal at low temperatures. . .
`
`Ex. 2046, p. 1; ZFL, p. E1. Dr. Sastry admitted that people of ordinary skill in the
`
`art (“POSITAs”) knew that “the fact that Oxonia [i.e., H2O2 and PAA] is an
`
`effective sterilant at a lower temperature than [H2O2] ma[d]e Oxonia a good
`
`candidate for use in sterilizing containers that are less heat-resistive.” Ex. 2069,
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`272:8-273:3; see also id. at 271:9-17.
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`2
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`B.
`Blakistone Promotes The Use Of PAA
`PO asserts that Blakistone (Ex. 2046) teaches away from using PAA in ZFL
`
`by questioning the efficacy of PAA to kill B. cereus. Paper 27, p. 31-33. PO is
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`wrong for at least four different reasons.
`
`1.
`
`Blakistone Promotes The Consideration Of PAA As A
`Sterilant For Low-Acid Aseptic Packaging Systems
`
`Blakistone acknowledges that the pathogen B. cereus appeared to be
`
`resistant to PAA in Blakistone’s particular tests. Ex. 2046, pp. 262, 267.
`
`Blakistone nonetheless affirmatively promoted consideration of PAA as a sterilant
`
`for low-acid aseptic packaging, particularly in view of the “admittedly low” PAA
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`temperatures and concentrations that Blakistone tested. Ex. 2046, p. 267.
`
`Blakistone recommended “[f]urther work” to consider whether higher temperatures
`
`or PAA concentrations would be more effective against B. cereus, thereby proving
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`that it was obvious to try using PAA/H2O2 mixtures in low-acid systems. Id.
`
`2.
`PO Misstates The Relative Effectiveness of PAA and H2O2
`PO mistakenly cites Blakistone as proving that PAA “was known to be about
`
`three times less effective than hydrogen peroxide in a LAASF” test. Paper 27, p.
`
`31. Yet, even PO’s expert admits that PO is “comparing apples and oranges” (Ex.
`
`2069, 270:14-271:8) because Blakistone tested PAA at a 0.1% concentration but
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`tested H2O2 at a “35%” concentration. Ex. 2046, p. 263; Ex. 2069, 275:9-23;
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`compare Ex. 2046, p. 263 (testing a 0.1% concentration of PAA) with Ex. 2046, p.
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`3
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`IPR2014-00055: U.S. Patent No. 6,536,188
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`266 (recognizing that PAA alone “inactivates 106 to 107 spores of B. cereus” (a 6-7
`
`log reduction)). A concentration of H2O2 350 times higher than PAA achieved just
`
`a three times higher kill rate. Id. It was for precisely this reason that Blakistone
`
`recommended that higher concentrations of PAA be explored for low-acid aseptic
`
`applications. Blakistone (Ex. 2046), p. 267.
`
`3.
`
`A 4 Log Reduction Of B. Cereus Using PAA Would Satisfy
`The FDA
`Even if the combination of PAA and H2O2 had a lower kill-rate against B.
`
`cereus than C. botulinum (that is not so, as explained above), it would still be
`
`obvious to use PAA because (1) the “severity of illness presented by B. cereus is
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`much lower tha[n] C botulinum,” and (2) initial bottle contamination of B. cereus
`
`was much lower, making the “12D [log] Concept” that was applied to Clostridium
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`Botulinum “tremendously excessive for PAA sterilization of plastic bottles.” Ex.
`
`2021, pp. 26, 33-34. A mere “4” log reduction in B. cereus satisfied the FDA’s
`
`LAASF requirements. Ex. 2021, p. 34; id. at 26-33. Since ZFL already achieved a
`
`“>8” log reduction of B. cereus (ZFL, p. E3) using H2O2 alone, a POSITA would
`
`have known that the use of H2O2 already provided an ample kill rate for B. cereus,
`
`and that the addition of PAA would beneficially increase the kill rate of B. subtilis
`
`and C. botulinum. Cf. Ex. 2046, p. 266 (recognizing that PAA alone “inactivates
`
`106 to 107 spores of B. cereus” (a 6-7 log reduction)). The addition of PAA to ZFL
`
`was therefore obvious.
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`4
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`Claim 40 and ZFL Are Not Limited To Low-Acid Foods
`
`4.
`PO’s assertion that PAA was inapplicable to low-acid aseptic systems is
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`irrelevant because claim 40 is not limited to low-acid systems (see Section IV.D,
`
`infra), and ZFL’s machine bottles high and low acid foods. Ex. 1001, claim 40;
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`ZFL (Ex. 1020), p. E1 (acidic “citrus juices”); id. at E4 (“fruit juices”).
`
`Blakistone promotes, rather than teaches away from, the use of PAA.
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`C.
`
`It Was Obvious To Use PAA In ZFL Even Though PAA Was Not
`FDA-Approved
`PO asserts that it was nonobvious to use PAA in ZFL because PAA was not
`
`an FDA approved sterilant in the prior art timeframe. Paper 27, p. 33. To the
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`contrary, using PAA in ZFL was obvious for several reasons.
`
`First, the prior art motivated POSITAs to use PAA (Sections I.A & I.B) and
`
`seek FDA approval for such use. Ex. 2046, p. 262 (acknowledging that PAA as an
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`alternative to H2O2 is “being sought” despite the fact that only H2O2 was FDA
`
`approved); Ex. 1041, 302:15-303:4 (POSITAs “may have anticipated that there
`
`could be progress made with Oxonia” in obtaining FDA approval).
`
`Second, it was obvious to use PAA in a ZFL machine outside the U.S.
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`because PAA was commonly used as a sterilant in other countries. Chambers, (Ex.
`
`1008), p. 60 (discussing PAA’s “worldwide” use as a sterilant); id. at 65
`
`(espousing the benefits of PAA as a sterilant); Ex. 1041, 303:4-6 (“[T]hey could
`
`use [PAA] overseas because they may not have the – the restrictions on using it.”).
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`Third, PO cannot claim an impossibility (the FDA-approved use of PAA)
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`and then disparage the prior art for not achieving the impossible. Claim 40’s
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`“aseptically disinfecting” limitation requires compliance with FDA standards.
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`Paper 27, pp. 23-25; Ex. 1001, 4:26-27. PO’s patent explains that “[f]or the aseptic
`
`packaging of food products, an aseptic filler must, for example, use an FDA . . .
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`approved sterilant.” Ex. 1001, 1:46-49. Claim 40’s “aseptically disinfecting”
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`limitation therefore precludes the use of PAA because PAA was not FDA
`
`approved when PO filed for its patent, and construction is determined as of that
`
`filing date. Ex. 1041, 302:1-6; Ex. 2046, p. 262; Kopykake Enters., Inc. v. Lucks
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`Co., 264 F.3d 1377, 1383 (Fed. Cir. 2001) (“[W]hen a claim term understood to
`
`have a narrow meaning when the application is filed later acquires a broader
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`definition, the literal scope of the term is limited to what it was understood to mean
`
`at the time of filing.”). Thus, claim 40 contradictorily requires and prohibits the
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`use of PAA. Because Petitioner cannot assert indefiniteness here, PO should not
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`be allowed to rely on claim 40’s impossibility as a way of avoiding obviousness.
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`II. Using PAA And H2O2 In ZFL Would Obviously Result In At Least A 6
`Log Reduction Of Spore Organisms On The Bottles
`PO asserts that using PAA and H2O2 in ZFL would not obviously sterilize
`
`bottles “to a level producing at least a 6 log reduction in spore organisms” (claim
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`40). Paper 27, p. 30. PO is wrong because H2O2 alone already achieved log
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`reductions of “>5” log for B. Subtilis, “>8” log for B. cereus, and over 12 log for
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`6
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`C. Botulinum. ZFL, p. E3; Paper 17, pp. 29-33; Ex. 2068, 19:17-20:1; Ex. 1048, p.
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`15. Adding PAA to ZFL’s H2O2 would obviously increase the 6+ log reductions
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`already achieved in ZFL, particularly with respect to the PAA-sensitive spore
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`organisms, C. Botulinum and B. Subtilis. Chambers (Ex. 1008), p. 65 (“H2O2 . . .
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`when combined with [PAA], had an additive sporicidal effect. . .”); Ex. 2046,
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`abstract. Using PAA and H2O2 in ZFL would obviously sterilize bottles “to a level
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`producing at least a 6 log reduction in spore organisms,” as recited in claim 40.
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`III. ZFL Anticipated Or Rendered Obvious Claim 40’s 101+ BPM Speed
`As the Board’s institution decision found, ZFL’s 200 BPM speed anticipates
`
`claim 40’s 101+ BPM limitation. Paper 7, p. 17; ZFL, p. E3 (“working” 200 BPM
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`plant), E4 (“200/min”). Even if ZFL did not teach a 101+ BPM speed, ZFL
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`certainly taught that “100” BPM speeds were achieved in U.S. plants by 1991 and
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`satisfied “U.S.” FDA regulations. ZFL, p. E4, E3. PO does not deserve a patent
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`for nudging ZFL’s reduced-to-practice speed up by 1 BPM, particularly where PO
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`itself never even built the machine in PO’s patent or tested it to confirm that it
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`could achieve the claimed 101+ BPM speed. ZFL, p. E4; Ex. 1044, p. 12, ¶ 116.
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`First, it was obvious to add lanes to ZFL to increase ZFL’s filling rate and/or
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`degree of sterilization. Paper 17, pp. 18-22; ZFL (Ex. 1020), p. E4 (doubling the
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`lanes to achieve 200 BPM); Ex. 1021, p. 33; Spinak Decl. (Ex. 1040), ¶ 24(d); Ex.
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`1048, pp. 14-15; Ex. 1021, p. 31-32. PO’s expert admitted that running two ZFL
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`7
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`machines side-by-side would double ZFL’s speed. Ex. 2068, 166:14-23. This
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`“mere duplication of parts has no patentable significance” because it would not
`
`produce “a new and unexpected result.” MPEP 2144.04(VI)(B) (citing In re
`
`Harza, 274 F.2d 669, 671, 124 USPQ 378, 380 (CCPA 1960). PO’s Response
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`does not dispute the obviousness or enablement of adding lanes to ZFL. Paper 27.
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`Thus, increasing ZFL’s sterilization/filling rates through additional lanes or
`
`machines was obvious.
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`Second, it was obvious to increase ZFL’s sterilization rate and BPM speed
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`by exposing the bottles to “repeated H2O2 treatment” and/or longer sterilant contact
`
`tunnels. Paper 17, p. 18-19; Spinak Decl. (Ex. 1040), ¶ 24(d); Ex. 2068, 76:18-
`
`78:8. For example, two of ZFL’s bottle sterilizers could obviously be lined up
`
`sequentially to double the sterilization effect on the bottles without reducing (or
`
`while increasing) the BPM speed. Spinak Decl. (Ex. 1040), ¶ 24(d); Ex. 2068,
`
`70:6-10 (Sastry admission that “the log reduction provided by sequential
`
`treatments is added together to determine the total log reduction”).
`
`It was obvious to modify ZFL to satisfy claim 40’s sterilization/filling rates.
`
`IV. The Prior Art Enabled The Claimed Use Of PAA In ZFL
`PO asserts that the prior art did not enable the use of PAA in ZFL in a
`
`manner that would meet claim 40’s sterilization and speed limitations. Paper 27,
`
`pp. 30-35. PO is wrong because (A) the prior art’s teachings were as detailed as
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`8
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`PO’s patent, (B) achieving the claimed sterilization/filling rates with PAA and
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`H2O2 required only routine experimentation with known, result-effective variables,
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`(C) the industry routinely satisfied the allegedly elusive FDA regulations, and (D)
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`PO improperly limits its obviousness analysis to low-acid products/processes.
`
`A. The Prior Art Is Enabled Because It Is As Detailed As PO’s
`Patent Regarding The Use Of PAA As A Sterilant
`
` PO asserts that the prior art is non-enabled because it fails to disclose the
`
`processing conditions needed to use PAA in ZFL to satisfy claim 40. Paper 27, pp.
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`33-35. PO’s hypocritical argument fails because PO’s own presumably enabled
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`patent discloses no processing conditions for PAA. Ex. 1001; Ex. 2069, 289:22-
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`291:8; SRI International, Inc. v. Internet Security Systems, Inc., 511 F.3d 1186,
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`1194 (Fed. Cir. 2008); In re Paulsen, 30 F.3d 1475, 1481 n.9 (Fed. Cir. 1994)
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`(“[U]nder the enablement standard that [patentee] would have us apply to [the
`
`reference], the . . . patent itself would be non-enabling.”); Motorola, Inc. v.
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`Interdigital Tech. Corp., 121 F.3d 1461, 1471 (Fed. Cir. 1997); In re Epstein, 32
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`F.3d 1559, 1568 (Fed. Cir. 1994). Petitioner’s petition showed that the prior art
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`was enabled because it “was as detailed as the ‘188 Patent.” Paper 17, p. 20. PO
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`did not respond or refute this. Paper 27. PO’s failure to respond with even one
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`distinguishing teaching in PO’s own patent confirms that the prior art was enabled.
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`The H2O2 processing conditions disclosed in PO’s patent are not pertinent to
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`the enabling use of PAA because PO’s expert admits that the processing conditions
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`9
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`appropriate for H2O2 materially differ from those appropriate for PAA (Ex. 2069,
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`266:11-275:23). Regardless, PO’s patent and the prior art both disclose
`
`comparable H2O2 processing conditions. Ex. 1008, 60; Ex. 2069, 305:8-15; Ex.
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`1003, p. 1; Ex. 1020, passim; Ex. 1001, passim. The prior art was enabled because
`
`it was as detailed as PO’s own patent with regard to how to use PAA to achieve the
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`claimed sterilization and filling rates.
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`B. Modifying ZFL To Use PAA And H2O2 Required Only Routine
`Experimentation With Known Result-Effective Variables
`
`PO argues that the prior art did not enable the claimed sterilization/filling
`
`rates because the industry commonly used “countless hours of R&D,” “trial and
`
`error,” “five to seven years” to develop a low-acid system, and another “about two
`
`years” to validate LAASF systems. Paper 27, pp. 15-16. Here, PO fatally
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`confuses routine and undue experimentation:
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`[E]xperimentation needed to practice the invention must not be undue….
`The key word is “undue,” not “experimentation.”… [A] considerable
`amount of experimentation is permissible, if it is merely routine….
`
`In Re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). PO’s admission proves that long
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`development timeframes and significant experimentation were routine in this
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`aseptic packaging art. Paper 27, pp. 19, 15-16; Ex. 2070, 568:6-19; Ex. 1021, p.
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`92 (PTO finding that adding lanes was obvious and enabled to increase BPM speed
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`because “[s]ignificant engineering and testing, even if required to add more
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`10
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`production lines, does not automatically equate to undue experimentation”); Ex.
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`1021, pp. 31-32; Ex. 1048, pp. 14-15; Exs. 2024 & 2025 (no testing done by PO’s
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`declarants); Ex. 2068, 141:4-14 and 150:22-24.
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`
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`The process parameters that PO alleges to be unpredictable (e.g., sterilant
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`concentration, contact time, temperatures, flow rates, multiple lanes, extended
`
`contact tunnels) were well-known result-effective parameters, as even PO’s expert
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`admits. Paper 17, p. 16-17; Chambers (Ex. 1008), p. 61, Table 5; Spinak Decl. (Ex.
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`1040), ¶ 24(c); ZFL, p. E2-3; Ex. 2024, ¶¶ 40-41; Ex. 2068, 89:22-91:10.
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`Moreover, Blakistone explicitly identified temperature and concentration as
`
`parameters to be optimized when using PAA and H2O2 as a sterilant. Blakistone
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`(Ex. 2046), p. 267. Here, “the general conditions of a claim are disclosed in the
`
`prior art” so “it is not inventive to discover the optimum or workable ranges by
`
`routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955). Indeed,
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`“differences in concentration or temperature will not support the patentability of
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`subject matter encompassed by the prior art unless there is evidence indicating
`
`such concentration or temperature is critical.” MPEP § 2144.05(II)(A) (citing
`
`Aller). Such PAA processing parameters must not have been critical to enablement
`
`because PO’s patent does not even disclose, much less claim, them.
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`Industry LAASF Systems Routinely Obtained FDA Approval
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`C.
`To support its non-enablement argument, PO argues that “many
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`manufacturers failed in their attempts to develop and validate FDA-compliant
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`LAASF processes,” but PO could only muster three examples. Paper 27, p. 13-15.
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`Two of those are inadmissible hearsay from biased litigants, and even one of them
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`“received FDA validation.” Id. at 13-14. The record soundly refutes PO’s
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`assertion that “many” manufacturers failed. Cf. Ex. 1008, p. 1 (“More than 500
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`aseptic systems [we]re in place in the U.S.” by 1993.); Ex. 1020, p. E4; Ex. 2014,
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`p. 155. PO overestimated the complexity of FDA approval by relying on experts
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`with no design or FDA experience in this aseptic packaging art (see Section V).
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`PO paid no heed to David’s “good advice” to use “someone who has experience in
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`this [aseptic packaging] field” (Ex. 2029, p. 136).
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`“Claim 40 Is Not Limited To “Low Acid” Products
`
`D.
`PO tries to read the limitation “low acid” into claim 40’s “aseptic[]” term.
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`Paper 27, pp. 26-29. “Aseptic” is not limited to “low acid aseptic” because even
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`PO’s expert admits that “high acid, low acid, and acidified foods can be considered
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`aseptic” and can be “used in aseptic processing and packaging.” Ex. 2024, ¶ 29.
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`The FDA regulates non-low-acid aseptic products, albeit at a different “level of
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`sterilization.” Id. The FDA has a “form for FDA filing for acidified aseptic foods”
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`(id.), and uses “the term ‘aseptic’ in connection with acidified products” (Ex. 2068,
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`91:14-25) in addition to low-acid products. Mr. Spinak, with his 15 years of FDA
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`experience, also testified that the FDA uses the term “aseptic” in connection with
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`12
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`low-acid, high-acid, and acidified foods. Ex. 1040 ¶¶ 10-12. PO’s discussion of
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`the “aseptic sterilization of high acid products” proves that the term “aseptic[]” is
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`not limited to low-acid products. Paper 27, p. 29. In the reexam of the related
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`‘468 patent, the PTO just rejected PO’s “low-acid” interpretation. Ex. 1045, p. 74-
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`75. PO’s specification even describes both low and high acid foods. Ex. 1001,
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`1:21-29. Under the broadest reasonable interpretation, “low-acid” is an example in
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`the specification, not a limitation in claim 40.
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`Even if claim 40 required a low-acid product, it is undisputed that ZFL’s
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`“UHT milk” satisfied this limitation. Ex. 1020, pp. E1, E4; Paper 21, pp. 27-29;
`
`Ex. 1040 ¶ 15. Similarly, even if claim 40 incorporated the FDA’s low-acid
`
`aseptic requirements, ZFL easily met such requirements because the FDA only
`
`ever required H2O2-based systems like ZFL to sterilize food packaging to a 4 log
`
`reduction of B. Subtilis (though POSITAs obviously sought a 6 log reduction to
`
`provide a margin of safety). Ex. 1042, 184:12-18 and 323:14-324:10; Ex. 2068,
`
`39:3-40:6; Ex. 2068, 38:2-6; Ex. 2068, 37:4-7. ZFL’s “>5D” (5 log) reduction of
`
`“Bac. Subtilis” easily satisfies FDA low-acid requirements, as demonstrated by
`
`ZFL’s prior “use[] in . . . the U.S.” and compliance with “U.S.” FDA standards.
`
`ZFL (Ex. 1020), p. E4, E3.
`
`V. Mr. Spinak Is The Only Aseptic Packaging Expert And Confirms The
`Obviousness Of Claim 40
`
`The parties offer competing experts to support their above-discussed
`
`
`
`13
`
`
`
`IPR2014-00055: U.S. Patent No. 6,536,188
`
`arguments, but Mr. Spinak is the only expert in the highly specialized aseptic
`
`packaging art of PO’s Patent. Mr. Spinak spent 15 years at the FDA evaluating
`
`low acid aseptic sterilization and filling (“LAASF”) systems, worked on almost
`
`every LAASF FDA application filed from 1991-2006, taught numerous “aseptic
`
`process and packaging courses” including the “Better Process Control” course
`
`required of all FDA-compliant aseptic operators (Ex. 1008, p. 246), and has aseptic
`
`packaging system design and validation experience. Ex. 1040 ¶ 3; Ex. 1042, 28:3-
`
`38:11 and 414:21-415:21. Mr. Spinak’s prior-art-supported opinions (Ex. 1040) on
`
`the thoughts and knowledge of POSITAs are therefore highly credible and show
`
`that claim 40 was obvious.
`
`In contrast, PO’s experts have no experience with aseptic packaging
`
`systems. Ex. 2068, 55:13-15 (Dr. Sastry admitting that he does not “have any
`
`personal experience in developing aseptic packaging systems”); Ex. 2068, 32:21-
`
`34:5; Ex. 2070, 483:13-484:4 (Dr. Sastry has “no practical experience in designing
`
`or developing aseptic fillers” and no “practical design, development, or building
`
`experience with respect to sterilizers for food containers in aseptic packaging
`
`systems”); Ex. 2068, 59:20-22 (Dr. Sastry has never “been involved in the FDA
`
`validation of any aseptic packaging system”); Ex. 2068, 38:2-6 and 37:4-7 (Dr.
`
`Sastry has no knowledge of any log reduction that was ever achieved in any
`
`approved or rejected LAASF FDA application); Ex. 2068, 28:13-16 (Dr. Sastry has
`
`
`
`14
`
`
`
`IPR2014-00055: U.S. Patent No. 6,536,188
`
`no “personal experience with using hydrogen peroxide solution as a sterilant”); Ex.
`
`2068, 88:11-14; Ex. 2068, 30:14-17; Ex. 2025 ¶ 7 (Dr. Sharon is “not an expert in
`
`aseptic processing and packaging”); Ex. 2071, 30:9-11; Ex. 2071, 33:11-12; Ex.
`
`2071, 88:5-11 (Dr. Sharon has no “personal knowledge of what was actually
`
`achieved or not achieved in the industry before February 2 of 1999 with respect to
`
`aseptic packaging systems.”); Ex. 2071, 41:25-42:7; Ex. 2071, 134:22-138:22 (Dr.
`
`Sharon has no understanding of the relevant principles of microbiology as required
`
`by PO’s own POSITA definition); Ex. 2071, 124:6-19 (Dr. Sharon did not know
`
`that oxonia comprised H2O2 and PAA). Dr. Sharon only just learned the “general
`
`principles of aseptic packaging” in May by reading Petitioner’s prior art. Ex.
`
`2025, ¶ 11; Ex. 2071, 15:11-17. Under PO’s definition of a POSITA (“10 years of
`
`experience in food packaging” (Paper 27, p. 17)), neither of PO’s experts are even
`
`POSITAs, much less experts. Ex. 2071, 43:25-44:6 (Dr. Sharon “do[es]n’t
`
`believe” he is a “POSITA” under PO’s definition). PO’s declarants deserve no
`
`weight because they have no experience with aseptic packaging.
`
`VI. Conclusion
`Claim 40 was obvious over the instituted combination of prior art.
`
`Date: August 8, 2014
`
`
`
`
`/William P. Atkins/
`William P. Atkins (Reg. No. 38,821)
`
`
`
`15
`
`
`
`CERTIFICATE OF SERVICE
`I hereby certify that a true copy of Petitioner’s attached PETITIONER’S
`
`REPLY TO PATENT OWNER’S RESPONSE is being served on August 8,
`
`2014 by email pursuant to an agreement between the parties on the attorneys of
`
`record of Steuben Foods, Inc., owner of the subject patent, as indicated below:
`
`Greg H. Gardella
`CPDocketGardella@oblon.com
`
`Kevin B. Laurence
`CPDocketLaurence@oblon.com
`
`Michael L. Kiklis
`CPdocketKiklis@oblon.com
`
`Ruby J. Natnithithadha
`CPdocketRJN@oblon.com
`
`Attorneys for Patent Owner
`
`
`
`
`
`PILLSBURY WINTHROP SHAW
`PITTMAN LLP
`/William P. Atkins/
`William P. Atkins
`Reg. No. 38,821
`Tel. No. 703.770.7777
`Fax No. 703.770.7901
`P.O. Box 10500
`McLean, VA 22102
`
`
`
`
`
`
`
`
`
`
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