Nestle USA, Inc.v.Steuben Foods, Inc.Download PDFPatent Trial and Appeal BoardMay 4, 201509306552 (P.T.A.B. May. 4, 2015) Copy Citation Trials@uspto.gov Paper 14 571-272-7822 Entered: May 4, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ NESTLÉ USA, INC., Petitioner, v. STEUBEN FOODS, INC., Patent Owner. ____________ Case IPR2015-00023 Patent 6,536,188 B1 ____________ Before PHILLIP J. KAUFFMAN, JAMES P. CALVE, and BEVERLY M. BUNTING, Administrative Patent Judges. BUNTING, Administrative Patent Judge. DECISION Denying Institution of Inter Partes Review 37 C.F.R. § 42.108 Case IPR2015-00023 Patent 6,536,188 B1 2 I. INTRODUCTION Petitioner, Nestlé USA, Inc. (“Nestle”), filed a petition (“Pet.”) requesting an inter partes review of claim 40 of U.S. Patent No. 6,536,188 B1 (Ex. 1001, “the ’188 patent”). Paper 2. Patent Owner, Steuben Foods, Inc. (“Patent Owner”), filed a preliminary response to the petition. Paper 8. We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the petition and the preliminary response, we conclude that Petitioner has not established a reasonable likelihood that it will prevail with respect to claim 40 of the ’188 patent. Accordingly, we deny inter partes review as to the challenged claim. II. BACKGROUND A. Related Proceedings Patent Owner states that it has asserted infringement by Petitioner of the ’188 patent in Steuben Foods, Inc. v. Nestle, USA, Case No. 1:13-cv-00892 (W.D.N.Y). Paper 7, 1–4; Pet. 46–47. The ’188 patent was reexamined in ex parte reexaminations control nos. 90/011,072 and 90/011,357, resulting in a Reexamination Certificate issued September 12, 2013. Paper 7, 2; Pet. 47. The ’188 patent was challenged in IPR2014-00055(terminated), and IPR2014-00056 (not instituted). Id. In addition, the ’188 patent is related to four other U.S. patents, each previously or presently the subject of a petition as indicated in the table below: Case IPR2015-00023 Patent 6,536,188 B1 3 U.S. Patent No. Petition 6,945,013 IPR2014-00041, IPR2014-01235 6,475,435 IPR2014-00043, IPR2015-00195 6,209,591 IPR2014-00051, IPR2015-00094 6,481,468 IPR2014-00054, IPR 2015-00249 Paper 7, 3–4; Pet. 47–48. B. The ’188 Patent (Ex. 1001) The ’188 patent is directed to an aseptic packaging system for the aseptic packaging of food products in containers, such as bottles. Ex. 1001, 1:10-12. The ’188 patent discloses the steps of: providing a plurality of bottles; aseptically disinfecting the plurality of bottles to a level producing at least a 6 log reduction in spore organisms; filling the aseptically disinfected plurality of bottles with the aseptically sterilized foodstuffs; filling the aseptically disinfected plurality of bottles at a rate greater than 100 bottles per minute; and disinfecting the interior of the plurality of bottles with a hot hydrogen peroxide spray, wherein disinfecting the interior of the plurality of bottles includes the application of the hot hydrogen peroxide spray for about 1 second and the activation and removal of the hot hydrogen peroxide using hot aseptically sterilized air for about 24 seconds. Id. at 3:9-18; 2:56-60. The ’188 patent also discloses the use of a measuring device (e.g. a plurality of 0.5 ml measuring cups) for measuring a quantity of sterilant, use of peroxyacetic acid and hydrogen peroxide as a sterilant, and use of a concentration sensor to ensure that the concentration of peroxyacetic acid and hydrogen peroxide is maintained at a predetermined level. Id. at 5:43-45, 57-65; 15:29-31. Case IPR2015-00023 Patent 6,536,188 B1 4 C. Representative Claims Petitioner challenges independent claim 40 of the ’188 patent, which is reproduced below. 40. A method for aseptically bottling aseptically sterilized foodstuffs comprising the steps of: providing a plurality of bottles; aseptically disinfecting the plurality of bottles to a level producing at least a 6 log reduction in spore organisms; filling the aseptically disinfected plurality of bottles with the aseptically sterilized foodstuffs; and filling the aseptically disinfected plurality of bottles at a rate greater than 100 bottles per minute; wherein the step of aseptically disinfecting of the plurality of bottles further includes a measuring device for measuring a quantity of sterilant, and wherein the sterilant is peroxyacetic acid and hydrogen peroxide; and wherein the peroxyacetic acid and hydrogen peroxide uses a concentration sensor to ensure that the concentration of the peroxyacetic acid and hydrogen peroxide is maintained at a predetermined level. D. The Evidence of Record PETITIONER relies upon the following prior art references (Pet. 11), and the declaration of Dennis R. Heldman, Ph.D. (Ex. 1004): References Patents/Printed Publications Date Ex. Hayashi Mitsuo Hayashi, New Technology for CAF Aseptic Filling, Beverage Japan, No. 193 at 73–75. Also at Exhibit 1021 with translation affidavit. Jan. 1998 1005 Campden Aseptic Packaging of Foodstuffs – possibilities and future prospects, Aseptic Packaging, Campden Food Preservation Research Association, Aseptic Packaging, Prcdgs. of Seminar, Stratford-upon-Avon, 1-10. Apr. 20, 1983 1007 Case IPR2015-00023 Patent 6,536,188 B1 5 E. Asserted Grounds of Unpatentability PETITIONER challenges the patentability of claim 40 of the ’188 patent as anticipated under 35 U.S.C. § 102(b) by Hayashi; or in the alternative as obvious under 35 § U.S.C. 103(a) over Hayashi, in view of one or more of Campden, Willhoft, Rose, Oxonia, Cosentino, Baldry and Teske. 1 Pet. 11. 1 By arguing the combination of Hayashi, Campden, Willhoft, Rose, Oxonia, Cosentino, Baldry and Teske in the alternative, Petitioner is in essence asserting numerous grounds based on the various permutations. The function of the Board is not to comb through Petitioners arguments in order to decipher the strongest Willhoft E.M.A. Willhoft, Aseptic Processing and Packaging of Particulate Foods, Blackie Academic & Professional, 1-38. 1993 1008 Rose E. Rose, Pt. 1: Principles of Design, Installation and Commissioning, GOOD MANUFACTURING PRACTICE – GUIDELINES FOR THE PROCESSING AND ASEPTIC PACKAGING OF LOW-ACID FOODS (1 st ed. 1986). 1986 1009 Oxonia 1997 Label Oxonia Active Label (EPA Reg. No. 1677-129) (accepted Jun. 19, 1997), available at http://www.epa.gov/pesticides/chem_search/ppls/0016 77-00129-19970619.pdf, last accessed Sept. 5, 2014. June 1997 1010 Cosentino U.S. Patent No. 5,400,818 Mar. 28, 1995 1011 Baldry M.G.C. Baldry, The Bactericidal, Fungicidal and Sporicidal Properties of Hydrogen Peroxide and Peracetic Acid, 54 J. OF APPLIED BACTERIOLOGY 417-423 (June 1983). June 1983 1012 Teske U.S. Patent No. 5,503,720 Apr. 2, 1996 1013 Case IPR2015-00023 Patent 6,536,188 B1 6 III. ANALYSIS A. Claim Construction In an inter partes review, claim terms in an unexpired patent are given their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); see also In re Cuozzo Speed Tech., LLC, No. 778 F.3d 1271, 1281–82 (Fed. Cir. 2015) (“Congress implicitly adopted the broadest reasonable interpretation standard in enacting the [America Invents Act],” and “the standard was properly adopted by PTO regulation”). Under the broadest reasonable interpretation standard, claim terms are given their ordinary and customary meaning in view of the specification 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). Any special definition for a claim term must be set forth in the specification “with reasonable clarity, deliberateness, and precision.” In re Paulson, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In the absence of such a definition, limitations are not to be read from the specification into the claims. See In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Petitioner proposes a claim construction for each of the following claim terms: “a measuring device for measuring a quantity of sterilant;” and “wherein the peroxyacetic acid and hydrogen peroxide uses a concentration sensor to ensure that the concentration of the peroxyacetic acid and hydrogen peroxide is maintained at a predetermined level.” Pet. 13–14. Patent Owner does not dispute Petitioner’s proposed claim construction for these claim terms, and in turn proposes a claim construction for the claim term “aseptic.” Prelim. Resp. 6–8. Having considered argument or to determine the strongest combination of references to challenge the claims. Therefore, we exercise our discretion and consider the combination of Hayashi, Campden, Willhoft, Rose, Oxonia, Cosentino, Baldry and Teske. Case IPR2015-00023 Patent 6,536,188 B1 7 the evidence of record, for purposes of this decision, we see no need to construe expressly the terms “a measuring device for measuring a quantity of sterilant”; and “wherein the peroxyacetic acid and hydrogen peroxide uses a concentration sensor to ensure that the concentration of the peroxyacetic acid and hydrogen peroxide is maintained at a predetermined level.” We address below the claim term “aseptic”. Patent Owner argues that the claim term “aseptic” should be “limited to methods which achieve the FDA level of aseptic, which includes a requirement that the bottles have no more than a 0.5PPM of residual hydrogen peroxide.” Prelim. Resp. 8. Directing us to the Specification, Patent Owner asserts that the term “aseptic” is specifically defined in the ’188 patent as “the FDA level of aseptic.” Prelim. Resp. 6–7 (citing Ex. 1001, 4:22–27). Patent Owner also points to the recitation in claim 22 that the filled bottles “not have a residual level of hydrogen peroxide of about 0.5 ppm or more” in further support of its position. Id. at 7. Upon reviewing the Specification of the ’188 patent, we agree that the term “aseptic” is referred specifically to as “the United States FDA [Food and Drug Administration] level of aseptic.” Ex. 1001, 1:65˗67; see also 4:22˗27 (“The present invention provides an aseptic processing apparatus 10 that will meet the stringent FDA (Food and Drug Administration) requirements and 3A Sanitary Standards and Accepted Practices required to label a food product (foodstuffs) as ‘aseptic’. Hereafter, ‘aseptic’ will refer to the FDA level of aseptic”). For aseptic packaging and labeling of food products, the Specification states that the package, product, filling, and sealing each must comply with the applicable FDA standards. Id. at 1:45–65. By way of example, the Specification indicates that the applicable standard, after container drying, for residual hydrogen peroxide in the bottle is below about 0.5 PPM. Id. at 3:2–5; 4:50–55. The testimony of Petitioner’s Case IPR2015-00023 Patent 6,536,188 B1 8 declarant, Dr. Heldman, supports this interpretation, stating that the aseptic bottling processes described in the ’188 patent were “subject to FDA standards.” Ex. 1004 ¶ 27. Additionally, Petitioner acknowledges that the ‘188 patent describes how “aseptic bottling systems must meet certain FDA requirements, including the ‘use [of] an FDA . . . approved sterilant’ and ‘[maintaining] [t]he packaging material . . . in a sterile environment during filling, closure, and sealing operations. Pet. 3, (citing Ex. 1001, 1:46˗54). As such, Patent Owner’s construction is not necessarily the broadest reasonable interpretation of this claim phrase in the context of the entire disclosure. For purposes of this decision, we determine that the broadest reasonable construction of “aseptic” in light of the Specification of the ’188 patent is “to meet the United States FDA level of aseptic.” B. Rule 42.63(b) We first consider Patent Owner’s argument that Hayashi (Ex. 1005) and Hani (Ex. 1006) cannot be considered as references because each fails to comply with 37 C.F.R. § 42.63(b). Prelim. Resp. 4–6. In particular, Patent Owner argues that Hayashi and Hani are originally authored in Japanese, and Petitioner did not file an affidavit attesting to the accuracy of the associated translations. Id. at 4. This argument is not persuasive because we directed Petitioner to file, and Petitioner complied, as an exhibit the affidavits for each reference, previously served upon Patent Owner, attesting to the accuracy of the associated translation. Paper 10, 2; Ex. 1021, 1022. Case IPR2015-00023 Patent 6,536,188 B1 9 C. Anticipation Based on Hayashi Next, we turn to Petitioner’s asserted grounds of unpatentability and Patent Owner’s arguments in its preliminary response. Petitioner contends that claim 40 is anticipated under 35 U.S.C. § 102(b) by Hayashi. Pet. 11. Petitioner explains how Hayashi describes the claimed subject matter of the challenged claim and cites the Declaration of Dr. Heldman to support the analysis advocated in the Petition. Id. at 25–43 (citing Ex. 1004). Patent Owner counters that Hayashi does not disclose that its system would meet the FDA level of aseptic. Prelim. Resp. 6–9. Having considered the explanations and supporting evidence presented, we are not persuaded that Petitioner has presented sufficient evidence demonstrating that Hayashi discloses the claim limitations as recited in challenged claim 40. A detailed analysis of our determination follows after a brief overview of Hayashi. 1. Overview of Hayashi (Ex. 1005) Hayashi is an article authored by the president of Nippon, Krones, K.K. describing the Krones completely aseptic filling system for low acid foods. Ex. 1005, 1. The Krones machine described in Hayashi includes a “Spirasept” bottle sterilization and rinsing apparatus, a filling machine, and a capper with sterilizing apparatus. Id. at 2. The bottles enter the bottle sterilization and rinsing apparatus and are submerged in an antiseptic solution as illustrated in the Figure from Hayashi reproduced below. Case IPR2015-00023 Patent 6,536,188 B1 10 Spirasept Submersion Bath-Sterilization and Rinsing Apparatus. Id. at 4. After sterilization, the bottles are placed in a sterile water bath and rinsed of residual sterilization liquid “and are sent to the filler.” Id. at 5. Hayashi states that “[t]he decision about which filling system and which filling process to use may be made based on product characteristics (e.g., pulp matter or O2 pick up, etc.). Id. at 6. The filled bottles are then sealed. Id. at 6–9. Hayashi states that an advantage of the Krones system is that “[l]ine flexibility is high, from low speed to high speed (12,000 to 30,000 BPH of 1.5 liter PET bottles.” Id. at 9. Hayashi further notes that “[i]n a culture medium test at the Krones Germany headquarters, all heat resistant and chemical resistance micro-organisms were sterilized to the D6 level by submersion for 30 seconds at 40°C in a Spirasept sterilization bath using 1.5% P-3 oxonia active. However, we believe that a tougher sterilization process will be needed to handle the stubborn Chaetomium and Arthrinium microorganisms in Japan’s high heat, high humidity weather environment.” Id. at 9–10. Case IPR2015-00023 Patent 6,536,188 B1 11 2. Discussion To establish anticipation under 35 U.S.C. § 102, “all of the elements and limitations of the claim must be shown in a single prior reference, arranged as in the claim.” Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). Moreover, the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008); see In re LeGrice, 301 F.2d 929, 940–44 (CCPA 1962). If the reference discloses all of the claim limitations and enables the “subject matter that falls within the scope of the claims at issue,” the reference anticipates, and no “actual creation or reduction to practice” is required. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380–81 (Fed. Cir. 2003); see In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Against this backdrop, and with the principles identified above in mind, we consider Petitioner’s argument that Hayashi anticipates the method for aseptically bottling sterilized foodstuffs of claim 40. Pet. 25–46. Petitioner provides a brief summary of the Hayashi reference (Id. at 15–19), and claim charts identifying quotations in the reference corresponding with the claim elements (Id. at 39–43). We also consider Patent Owner’s argument that the Petition “fails to address the FDA level of aseptic or identify any evidence that the Hayashi system would meet the FDA level of aseptic.” Prelim. Resp. 9. In support thereof, Patent Owner argues that the Petitioner does not explain “how a person of ordinary skill in the art could expect to reproduce the system disclosed in Hayashi without undue experimentation.” Id. at 12. For the reasons provided supra, our consideration is Case IPR2015-00023 Patent 6,536,188 B1 12 based on our interpretation of the claim term “aseptic” as “to meet the United States FDA level of aseptic.” Claim 40 includes the limitation of “aseptically disinfecting the bottles to a level producing at least a 6 log reduction in spore organisms.” Ex. 1001, 6:17–18. Petitioner argues that this limitation is satisfied by the following disclosure in Hayashi describing how, “[i]n a culture medium test at the Krones Germany headquarters, all heat resistant and chemical resistance [sic] micro-organisms were sterilized to the D6 level by submersion for 30 seconds at 40°C in a Spirasept sterilization bath using 1.5% P-3 oxonia active.” Pet. 27 (citing Ex. 1004 ¶ 56; Ex. 1005, 10). Also pointing to the same statement from Hayashi, Patent Owner counters that this statement does not describe how the bottles are rinsed or dried, nor “any explanation of rinsing fluid composition, temperature, and flow rates as well as the drying gas composition, temperature and flow rate, all of which bear upon the critical step of sterilant removal.” Prelim. Resp. 13. Patent Owner contends that these elements are necessary to meet the FDA requirement that the bottle contain no more than 0.5 PPM sterilant residue. Id. (See also Ex. 1016, 54 (“The FDA regulations place a limit of a final concentration of not more than 0.5 ppm after packaging (Code of Federal Regulations, 1990a”); Ex. 2026 at 136 (“As previously mentioned, the FDA now permits only a hydrogen peroxide residue of 0.5ppm in a container”)). We are not persuaded that Petitioner’s arguments and evidence demonstrate sufficiently that the cited portion of Hayashi disclose aseptically disinfecting the bottles to a level producing at least a 6 log reduction in spore organism to meet the United States FDA level of aseptic. Patent Owner argues persuasively that Hayashi does not disclose that the bottles are aseptically disinfected to a level producing at least a 6 log reduction in spore organisms to meet the FDA level of Case IPR2015-00023 Patent 6,536,188 B1 13 aseptic. Prelim. Resp. 6–9. Moreover, Petitioner’s citation to the statement in Hayashi that “the CAF system can flexibly . . .increase concentration or temperature, or lengthen processing time” to achieve higher disinfection rates, e.g., “to handle the stubborn Chaetomium and Arthrinium [mold] microorganisms” (Pet. 27 (citing Ex. 1005, 10)) and conclusion that “the Krones CAF method may be modified to achieve 6-log spore reductions of even the most resistant spores,” (Id. (citing Ex. 1004 ¶ 56)) suggests a lack of disclosure in this regard. Petitioner also argues that Hayashi inherently teaches the claim limitation of “filling the aseptically disinfected plurality of bottles with the aseptically sterilized foodstuffs” based on the characterization of the Krones CAF method in its title as “aseptic filling.” Pet. 27˗28 (citing Ex. 1005, 1). As to the inherent disclosure of aseptic foodstuff, Petitioner relies on the testimony of its expert, Dr. Heldman, that a person of ordinary skill in the art would understand aseptic filling “to mean that it fills disinfected bottles with aseptically sterilized foodstuffs.” Id. at 28 (citing Ex. 1004 ¶ 57). We are not persuaded by these arguments. Neither Petitioner, nor its declarant, Dr. Heldman, proffer evidence sufficient to support a finding that Hayashi expressly or inherently describes how the foodstuff is aseptically sterilized so as to meet the applicable United States FDA level of aseptic. “[A]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.” Rexnord Indus., LLC v. Kappos, 705 F.3d 1347, 1355 (Fed.Cir. 2013) (quoting In re Omeprazole Patent Litigation, 483 F.3d 1364, 1378 (Fed. Cir. 2007)). Petitioner further contends that Hayashi expressly teaches the claim limitation of filling the aseptically disinfected plurality of bottles “at a rate greater than 100 bottles per minute.” Id. at 31 (citing Ex. 1005, 9). In its Preliminary Case IPR2015-00023 Patent 6,536,188 B1 14 Response, Patent Owner argues that the Petitioner does not explain how Hayashi could be duplicated without undue experimentation or with any reasonable expectation of success. Prelim. Resp. 9–14. We are not persuaded, for purposes of this decision, that Hayashi sufficiently describes the claimed invention to have placed the public in possession of filling the aseptically disinfected bottles “at a rate greater than 100 bottles per minute.” See In re Donohue, 766 at 533 (to anticipate, the prior art must sufficiently describe the claimed invention to have placed the public in possession of it, such that “one of ordinary skill in the art could have combined the publication’s description of the invention with his own knowledge to make the claimed invention”). Petitioner’s declarant, Dr. Heldman, merely points to the statement in Hayashi that “the Krones CAF method provides bottling rates from 12,000 to 30,000 bottles per hour—i.e., 200 to 500 bottles per minute—for 1.5-liter PET bottles.” Ex. 1004 ¶ 58 (citing Ex. 1005, 9). Dr. Heldman, however, does not proffer any analysis or evidence in support of this statement. Nonetheless, we consider the Hayashi reference in context. Hayashi is not a patent; rather, Hayashi is non-patent literature, i.e. an article published in Japanese in a 1998 issue of Beverage Japan authored by Mitsuo Hayashi, presenting an aseptic filling system from a German manufacturer, Krones. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (prior art patents are presumed enabled). For example, Hayashi explicitly discloses that the article provides an “outline” of the Krones system. Ex. 1005, 1–2. Having carefully reviewed Hayashi, we agree with Patent Owner’s characterization of Hayashi as “a high-level overview of the machine” that does not provide sufficient detail regarding how the bottles are rinsed or dried, explanation of rinsing fluid composition, temperature, and flow rates, as well as the drying gas composition, Case IPR2015-00023 Patent 6,536,188 B1 15 temperature and flow rate, that determine sterilant removal in order to meet the United States FDA level of aseptic. Prelim. Resp. 13. As such, Petitioner’s reference (Pet. 31) to Hayashi’s statement that an advantage of the Krones CAF method is that “[l]ine flexibility is high, from low speed to high speed (12,000 to 30,000 BPH of 1.5 liter PET bottles” (Ex. 1005, 9), without further enabling disclosure, does not persuade us, for purpose of this decision, that Hayashi anticipates claim 40. See Helifix Ltd. v. Blok–Lok, Ltd., 208 F.3d 1339, 1346 (Fed.Cir.2000) (to be anticipating, a prior art reference must be disclose each and every limitation of the claimed invention, be enabling, and describe the claimed invention sufficiently to have placed it in possession of a person of ordinary skill in the art). Having considered the evidence of record, we are not persuaded by Petitioner’s argument that Hayashi discloses each of the limitations of claim 40 for the reasons provided. As such, Petitioner does not demonstrate a reasonable likelihood that it will prevail on its assertion that claim 40 is anticipated by Hayashi. D. Obviousness based on Hayashi Petitioner contends that claim 40 would have been obvious over Hayashi and one or more of Campden, Willhoft, Rose, Oxonia 1997 Label, Cosentino, Baldrey, and Teske. Pet. 25-46. Having considered the explanations and supporting evidence presented, we are not persuaded that Petitioner demonstrates a reasonable likelihood of prevailing on its assertion that challenged claim 40 is obvious over Hayashi, Campden, Willhoft, Rose, Oxonia 1997 Label, Cosentino, Baldrey, and Teske. Case IPR2015-00023 Patent 6,536,188 B1 16 1. Discussion A patent claim is unpatentable, under 35 U.S.C. § 103(a), if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations, including: (1) the scope and content of the prior art, (2) any differences between the claimed subject matter and the prior art, (3) the level of skill in the art, and (4) where in evidence, so- called secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Against this backdrop, we consider Petitioner’s arguments. Petitioner asserts that Hayashi discloses the claim limitation of “aseptically disinfecting the bottles to a level producing at least a 6 log reduction in spore organisms.” Pet. 27. Petitioner does not rely on any disclosure within the cited secondary references to solve the above-noted deficiency in Hayashi regarding this limitation. For the reasons provided supra, Petitioner does not persuade us that the cited portion of Hayashi discloses the claim limitation of aseptically disinfecting the bottles to a level producing at least a 6 log reduction in spore organisms to meet the United States FDA level of aseptic. We next consider Petitioner’s argument that Hayashi discloses the claim limitation of filling the aseptically disinfected plurality of bottles at a rate greater than 100 bottles per minute. For the reasons provided supra with regards to the anticipation analysis of Hayashi, we are not persuaded that Hayashi sufficiently describes the claimed invention, in order to have placed the public in possession of filling the aseptically disinfected bottles “at a rate greater than 100 bottles per Case IPR2015-00023 Patent 6,536,188 B1 17 minute.” Moreover, Petitioner does not rely on any of the secondary references to resolve this noted deficiency in Hayashi. Based on the foregoing analysis, we conclude that Petitioner has not demonstrated a reasonable likelihood that it will prevail as to its contention that claim 40 would have been obvious over the combination of Hayashi with Campden, Willhoft, Rose, Oxonia 1997 Label, Cosentino, Baldrey, and Teske. E. 35 U.S.C. § 315(b) Patent Owner proffers arguments asserting that the Petition is time-barred under 35 U.S.C. § 315(b) because the Petitioner failed to name GEA as a privy. Prelim. Resp. 14–33. Because we determine that the information presented in the Petition does not demonstrate a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, we exercise our discretion and do not address Patent Owner’s assertions that the Petition is time-barred under 35 U.S.C. § 315(b) based on privity. F. Pro Hac Vice Motion Petitioner has filed an unopposed motion for pro hac vice admission of Tyler M. Akagi. Paper 12. The motion is supported by an affidavit of Mr. Akagi. Ex. 1023. We have reviewed the submissions and determined that the requirements of 37 C.F.R. § 42.10 have been met and there is good cause to admit Mr. Akagi pro hac vice. Case IPR2015-00023 Patent 6,536,188 B1 18 IV. CONCLUSION For the foregoing reasons, we determine that the information presented in the Petition does not establish that there is a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of claim 40 of the ’188 patent. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petitioner for inter partes review of the ‘188 patent is DENIED; FURTHER ORDERED that Petitioner’s unopposed motion for pro hac vice admission of Tyler M. Akagi is granted; Mr. Akagi is authorized to represent Petitioner only as back-up counsel in this proceeding; FURTHER ORDERED that Petitioner is to continue to have a registered practitioner represent it as lead counsel for this proceeding; FURTHER ORDERED that Mr. Akagi is to comply with the Office Patent Trial Practice Guide and the Board’s Rules of Practice for Trials, as set forth in Part 42 of Title 37, Code of Federal Regulations; and FURTHER ORDERED that Mr. Akagi is to be subject to the Office’s disciplinary jurisdiction under 37 C.F.R. § 11.19(a), and the USPTO Rules of Professional Conduct set forth in 37 C.F.R. § 11.101 et. seq. Case IPR2015-00023 Patent 6,536,188 B1 19 PETITIONER: Thomas Jenkins Virginia Carron FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP tom.jenkins@finnegan.com virginia.carron@finnegan.com PATENT OWNER: Greg Gardella Scott McKeown Ruby Natnithithadha OBLON, SPIVAK, McCLELLAND, MAIER & NEUSTADT, L.L.P. 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