Trials@uspto.gov
`571-272-7822
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`Paper 10
`Date: May 17, 2021
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DANISCO US INC. and DUPONT NUTRITION BIOSCIENCES ApS,
`Petitioner,
`
`v.
`
`NOVOZYMES A/S,
`Patent Owner.
`____________
`
`IPR2021-00189
`Patent 10,555,541 B2
`____________
`
`
`
`Before JAMES A. WORTH, ROBERT A. POLLOCK and,
`RYAN H. FLAX, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 10
`Date: May 17, 2021
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DANISCO US INC. and DUPONT NUTRITION BIOSCIENCES ApS,
`Petitioner,
`
`v.
`
`NOVOZYMES A/S,
`Patent Owner.
`____________
`
`IPR2021-00189
`Patent 10,555,541 B2
`____________
`
`
`
`Before JAMES A. WORTH, ROBERT A. POLLOCK and,
`RYAN H. FLAX, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`IPR2021-00189
`Patent 10,555,541
`
`
`I.
`
`INTRODUCTION
`
`A. Background
`Danisco US Inc. and DuPont Nutrition Biosciences ApS (collectively,
`“Petitioner”) filed a Petition for an inter partes review of claims 1, 3–9, and
`11–17 of U.S. Patent No. 10,555,541 B2 (“the ’541 Patent,” Ex. 1001).
`Paper 1 (“Pet.”). Novozymes A/S (“Patent Owner”) timely filed a
`Preliminary Response. Paper 9 (“Prelim. Resp.”).
`
`B. Summary of the Institution Decision
`For the reasons provided below, we determine Petitioner has satisfied
`the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner
`has demonstrated a reasonable likelihood that at least one claim of the ’541
`Patent is unpatentable, we institute an inter partes review of all challenged
`claims on each of the Grounds raised in the Petition. See SAS Inst., Inc. v.
`Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of
`SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.
`uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/
`guidance-impact-sas-aia-trial) (“Guidance”).
`
`C. Real Parties-in-Interest
`Petitioner identifies Danisco US Inc., DuPont Nutrition Biosciences
`ApS, and International Flavors & Fragrances Inc. as real parties-in-interest.
`Paper 8.
`Patent Owner, identifies Novozymes A/S, Novozymes North America
`Inc. and Chr. Hansen A/S as real parties-in-interest. Paper 6, 1.
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`D. Related Matters
`Petitioner concurrently challenges claims of related patent, US
`10,058,107 B2 (“the ’107 patent”) in IPR2021-00188. See Paper 6, 1, Pet. 4,
`32 (flowchart illustrating relationship between related patents and patent
`applications). Petitioner explains that “[t]he claims of the ’541 Patent are
`nearly identical to the claims of the ’107 patent, differing only by the added
`requirement that the claimed polypeptide is “isolated.” Pet. 4. Petitioner
`further notes that the ’541 Patent is terminal disclaimed over the earlier-
`issued ’107 patent. Id.
`
`E. Asserted Ground of Unpatentability
`Petitioner asserts a single ground of unpatentability (Pet. 6):
`Claims Challenged
`Statutory Basis
`Reference(s)
`1, 3–9, 11–17
`§ 1031
`Larsen2
`
`In support of its patentability challenge, Petitioner relies on, inter alia,
`the Declaration of Douglas S. Clark, Ph.D. Ex. 1002. Based on the
`preliminary record before us, we determine that Dr. Clark is qualified to
`offer testimony on the knowledge of one of ordinary skill in the art as of any
`of the asserted priority dates of the ’541 Patent. See, e.g., id. ¶¶ 3–38
`(Dr. Clark’s statements as to his background and qualifications, and
`
`
`1 Petitioner asserts that the ’541 Patent has a priority date of February 15,
`2017, which is after the AIA revisions to 35 U.S.C. § 103 (and § 112) took
`effect. Patent Owner asserts that the ’541 Patent has a priority date at least as
`early as December 2, 2008, which is before the AIA took effect. Regardless
`of whether we look to the pre- or post-AIA version of the Patent Act, the
`same substantive legal requirements apply and no change in the law impacts
`the outcome of this Decision.
`2 Larsen et al., US 2015/0223481 A1, published Aug. 13, 2015. Ex. 1003.
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`background on the relevant technology), ¶ 43 (Dr. Clark’s opinion regarding
`the definition of one of ordinary skill in the art), Appendix A (Dr. Clark’s
`curriculum vitae). At this stage of the proceeding, Patent Owner has not
`submitted, nor was it required to submit, similar testimony evidence.
`
`F. The ’541 Patent
`The ’541 Patent issued to Hendriksen et al., from U.S. Application
`16/380,220 (the ’220 application), filed April 10, 2019, via a series of
`continuation applications including U.S. Application 15/433,642, which
`issued as the ’107 Patent, and U.S. Application No. 12/744,508 (“the ’508
`application), first filed on December 2, 2008, as international application
`PCT/EP2008/066624 (“the ’624 PCT”). Ex. 1001, code (63), 1:7–17; see
`also Pet. 32 (flowchart). Accordingly, the ’541 Patent has substantially the
`same specification as the ’107 Patent, the ’508 application, and the ’624
`PCT.
`
`Although not implicated in our decision to institute trial, the ’541
`Patent further claims priority to U.S. Provisional Application 61/055,164
`filed May 22, 2008, U.S. Provisional Application 60/992,783 filed
`December 6, 2007, European Application 07122110.5 filed December 3,
`2007, and European Application 08156674.7 filed May 21, 2008. Ex. 1001,
`codes (60), (30), 1:6–21; see also Prelim. Resp. 3–4, n.2 (“For purposes of
`the IPR and the prior art status of Larsen, it is not necessary to reach the
`issue of whether the ʼ541 Patent claims are entitled to the earlier filing dates
`of these applications.”).
`
`Background and Specification
`1)
`The present invention involves enzymes from Bifidobacterium
`bifidum having lactase and transgalactosylase activities. See, generally,
`
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`Ex. 1001, 2:35–46. With respect to the former, the ’541 Patent’s Abstract
`states: “The present invention relates to a method for producing a dairy
`product using an enzyme having lactase activity.” Id. at Abstract; see also id.
`at 11:29–41 (defining lactases within the scope of the invention), 11:42–
`12:10 (biological sources for lactase enzymes). Consistent with the
`Specification, Dr. Clark explains that lactases, or more specifically, β-
`galactosidases, “are often used to hydrolyze the sugar lactose naturally
`present in milk, making low-lactose or lactose-free dairy products suitable
`for consumption by individuals unable to properly digest dairy products.
`During lactose hydrolysis, β-galactosidase cleaves lactose into equal
`amounts of two products, glucose and galactose.” Ex. 1002 ¶ 14; see
`Ex. 1001, 1:34–40. According to Dr. Clark:
`Some β-galactosidase enzymes can also convert lactose into
`galactooligosaccharides through a different reaction known as
`transgalactosylation. During transgalactosylation, the enzyme
`breaks lactose into glucose and galactose and transfers
`galactose to an accepting alcohol group of another carbohydrate
`(e.g., glucose, galactose, lactose, or galactose-containing
`oligosaccharides), building carbohydrate chains known as
`galactooligosaccharides (“GOS”).
`Id. ¶ 15 (internal citations omitted). These resulting galactooligosaccharides,
`or GOS, comprise “2 to 20 molecules of galactose and 1 molecule of
`glucose.” Ex. 1007, Abstract. Dr. Clark further explains that “GOS are non-
`digestible prebiotics that promote proliferation of microorganisms, such as
`healthy bacteria in yogurt, that can improve digestion and promote growth of
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`intestinal microflora.” Ex. 1002 ¶ 19 (citing Ex. 1005,3 2276; Ex. 1007,4
`471–172). For this reason, transgalactosylases “were recognized as useful
`for producing GOS in dairy products.” Id. (citing Ex. 1007, 472).
`The ’541 Patent is directed to “a method for producing a dairy product
`using an enzyme having lactase activity.” Ex. 1001, Abstract, Title. By way
`of background, the Specification states that, “[a] lactase from
`Bifidobacterium bifidum has been described having a high
`transgalactosylating activity, both in the full-length form and especially
`when truncated from the C-terminal end (see, e.g., Jørgensen et al. (2001),
`Appl. Microbiol. Biotechnol., 57: 647-652 or EP patent 1,283,876).” Id. at
`2:11–17. The cited Jørgensen reference (Ex. 1004 in this proceeding)5
`discloses that the full-length lactase from Bifidobacterium bifidum comprises
`1,752 amino acids, whereas “[d]eletion of approximately 580 amino acid
`residues from the C-terminal end converted the enzyme from a normal,
`hydrolytic β-galactosidase into a highly efficient, transgalactosylating
`enzyme.” Ex. 1004, Abstract.
`With respect to this same enzyme, the ’541 Patent Specification
`states:
`
`The present inventors have surprisingly found that a
`C-terminally truncated fragment of the extracellular lactase
`from Bifidobacterium bifidum, which was originally isolated
`and patented for its ability to make high amounts of
`
`3 P. L. Moller et al., 67 J. APPL. ENVIRON. MICROBIOL. 2276–2283 (2001).
`Ex. 1005.
`4 D. O. Otieno, Synthesis of β-Galactooligosachharides from Lactose Using
`Microbial β-Galactosidases, 9 J. COMPREHENSIVE REVIEWS IN FOOD
`SCIENCE AND FOOD SAFETY 471–482 (2010). Ex. 1007.
`5 F. Jorgensen et al., High-Efficiency Synthesis of Oligosaccharides with a
`Truncated β-Galactosidase from Bifidobacterium bifidum, 57 J. APPL.
`MICROBIOL. BIOTECHNOL. 647-652 (2001). Ex. 1004.
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`
`galactooligosaccharides from lactose, can be used very
`successfully for hydrolysis of lactose in milk. When tested in
`water +100 g/l lactose at 37° C., the enzyme makes
`galactooligosaccharides with high efficiency as described in the
`prior art. However, when tested in milk, the ratio of hydrolytic
`to transgalactosylating activity has changed markedly, resulting
`in efficient hydrolysis and very low production of
`galactooligosaccharides.
`Id. at 2:35–46.
`The Specification discloses a preferred embodiment comprising
`truncated Bifidobacterium bifidum lactase sequences, that are “at least 98%
`identical to amino acids 28-1931 of SEQ ID NO: 1 or to a lactase active
`fragment thereof.” Id. at 12:7–16. According the Specification, these
`“lactase active fragment[s]” include “any fragment of SEQ ID NO: 1 having
`lactase activity.” Id. at 12:16–18. More particularly, [a] lactase active
`fragment of SEQ ID NO: 1 may be, e.g., amino acids 28-979, amino acids
`28-1170, amino acids 28-1323, amino acids 28-1331, or amino acids 28-
`1600 of SEQ ID NO: 1.” Id. at 12:18–21.
`The ’107 patent explains that “[a] lactase in the context of the present
`invention is any glycoside hydrolase having the ability to hydrolyse the
`disaccharide lactose into constituent galactose and glucose monomers,” and
`“may have other activities than the lactose hydrolysing activity, such as for
`example a transgalactosylating activity.” Id. at 11:36–38. The Specification
`discloses that one of ordinary skill in art can determine the relative amounts
`of lactase and transgalactosylase activity by comparing the amounts of
`glucose and galactose produced. See, e.g., id. at 15:21–25, 43–51, 17:15–24,
`Table 1. The ’107 Patent describes one preferred embodiment in which
`the enzyme when hydrolysing the lactose in the milk-based
`substrate has a ratio of lactase to transgalactosylase activity of
`more than 1:1, such as more than 2:1 or more than 3:1. In
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`another preferred embodiment, the enzyme treatment is
`performed under conditions where the lactase activity of the
`enzyme is higher than the transgalactosylase activity, such as at
`least two times higher or at least three times higher.
`Id. at 15:35–43.
`The ’541 Patent discloses a series of Examples comparing Lactozym,
`a commercially available lactase, with a 1303 amino acid “experimental
`lactase from Bifidobacterium bifidum” and comprising amino acids 28–1331
`of SEQ ID NO: 2.6 Id. at 15:54–24:57; see id. at 16:46–55 (noting that
`“amino acids 1 to 27 of SEQ ID NO:2 is a signal sequence which is
`presumably cleaved off and amino acids 1332 to 1341 is a tag used for
`purification”). The Specification indicates that this Bifidobacterium bifidum–
`derived sequence had little to no transgalactosylating activity under
`conditions tested. See, e.g., id. at 17:15–16 (“When tested in milk with 5 %
`lactose, no transferase activity is observed when using the Bifidobacterium
`lactase.”), 18:17–19 (“Also when tested at higher lactose concentrations as
`in 15% or 30% whey permeate no or very little galactooligosaccharides are
`produced.”), 24:48–50.
`
`
`6 SEQ ID NO: 2 is not the amino acid 28–979 fragment of SEQ ID NO: 1
`and the relationship between these two sequences is not immediately clear.
`SEQ ID NO 1 purports to be a 1931 amino acid sequence from
`Bifidobacterium bifidum and SEQ ID NO: 2 purports to be a 1341 amino
`acid sequence from the same organism. Ex. 1001, Sequence Listing. A
`comparison of the sequences as presented in the Sequence Listing of the
`’541 Patent shows that although the first 27 N-terminal amino acids of the
`two sequences are the same, amino acids 28–30 of SEQ ID NO: 1 are ala,
`val, glu, but are ile, glu, asp in SEQ ID NO:2. The Panel has not compared
`the entirety of two sequences to determine whether or how they further
`diverge.
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`
`Challenged Claims
`2)
`Petitioner challenges claims 1, 3–9, and 11–17 of the ’541 Patent. Of
`these, independent claim 1 recites:
`1. A polypeptide having transgalactosylating activity, which is
`a truncated polypeptide consisting of the amino acid
`sequence of amino acids 28–979 of SEQ ID NO: 1 or is a
`fragment thereof having transgalactosylating activity,
`wherein the polypeptide is isolated.
`Ex. 1001, 83:23–27. Dependent claims 4–9 recite composition and method
`claims involving the polypeptide of claim 1. Also depending from claim 1,
`composition claim 3 specifies that “the truncated polypeptide consists of the
`amino acid sequence of a fragment of amino acids 28–979 of SEQ ID NO:
`1,” and thus excludes a sequence comprising the totality of amino acids 28–
`979 of SEQ ID NO: 1. Id. at 83:31–33.
`
`Independent claim 11 recites:
`11. A polypeptide having transgalactosylating activity, which is
`a fragment having an amino acid sequence which is at
`least 98% identical to amino acids 28–979 of SEQ ID NO:
`1, wherein the fragment consists of at most 952 amino acid
`residues and has transgalactosylating activity, wherein the
`polypeptide is isolated.
`Id. at 84:26–31. Dependent claims 12–17 are directed to compositions and
`methods involving the polypeptide of claim 11.
`
`II. ANALYSIS
`
`A. Legal Standards
`“In an IPR, the petitioner has the burden from the onset to show with
`particularity why the patent it challenges is unpatentable.” Harmonic Inc. v.
`Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C.
`§ 312(a)(3) (requiring inter partes review petitions to identify “with
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`particularity . . . the evidence that supports the grounds for the challenge to
`each claim”)). This burden of persuasion never shifts to Patent Owner. See
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015) (discussing the burden of proof in inter partes review).
`With respect to the filing date accorded a challenged patent, 35 U.S.C.
`§ 120 requires that “[a]n application for patent for an invention disclosed in
`the manner provided by section 112(a) (other than the requirement to
`disclose the best mode) in an application previously filed in the United
`States, or as provided by section 363 . . . shall have the same effect, as to
`such invention, as though filed on the date of the prior application . . . .”).
`“Section 120 places the burden on the patent owner to provide a clear,
`unbroken chain of priority.” Droplets, Inc. v. E*TRADE Bank, 887 F.3d
`1309, 1317 (Fed. Cir. 2018) (citing Medtronic CoreValve, LLC v. Edwards
`Lifesciences Corp., 741 F.3d 1359, 1356 (Fed. Cir. 2014)).
`To claim “the benefit of the filing date of an earlier application under
`35 U.S.C. § 120, each application in the chain leading back to the earlier
`application must comply with the written description requirement of
`35 U.S.C. § 112.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571
`(Fed. Cir. 1997). “[T]o satisfy the written description requirement, the
`disclosure as originally filed does not have to provide in haec verba support
`for the claimed subject matter at issue,” the disclosure, however, must
`convey with reasonable clarity to those skilled in the art that the inventor
`was in possession of the invention. Purdue Pharma L.P. v. Faulding, Inc.,
`230 F.3d 1320, 1323 (Fed. Cir. 2000). “[W]hatever the specific articulation,
`the test requires an objective inquiry into the four corners of the
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`specification from the perspective of a person of ordinary skill in the art.
`Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
`The Federal Circuit has emphasized that “‘[a]lthough § 120 might
`appear to be a technical provision,’ courts have long-recognized that ‘it
`embodies an important public policy,’ and thus have required strict
`adherence to its requirements.” Droplets, 887 F.3d at 1316 (citation
`omitted). “The purpose of the written description requirement is to prevent
`an applicant from later asserting that he invented that which he did not.”
`Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1330 (Fed. Cir.
`2003). Accordingly, “[e]ntitlement to a filing date does not extend to subject
`matter which is not disclosed, but would be obvious over what is expressly
`disclosed.” Lockwood, 107 F.3d at 1571–72; see also Ariad Pharms., 598
`F.3d at 1351 (“a description that merely renders the invention obvious does
`not satisfy the requirement.”). Likewise, a “mere wish or plan” for obtaining
`the claimed invention does not satisfy the written description
`requirement. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559,
`1566 (Fed. Cir. 1997).
`The level of disclosure required to provide a sufficient written
`description under Section 112 depends on the subject matter and breadth
`claimed, for example, whether it is a species or a genus that is claimed and
`whether a claim relies on recited functionality as a limitation. A “disclosure
`that names one species encompassed within a genus will adequately describe
`a claim directed to that genus only if the disclosure ‘indicates that the
`patentee has invented species sufficient to constitute the gen[us]’” and “a
`patentee will not be deemed to have invented species sufficient to constitute
`the genus by virtue of having disclosed a single species when . . . the
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`evidence indicates ordinary artisans could not predict the operability in the
`invention of any species other than the one disclosed.” In re Curtis, 354 F.3d
`1347, 1358 (Fed. Cir. 2004). Thus, for example, “[a] description of a genus
`of cDNAs may be achieved by means of a recitation of a representative
`number of cDNAs, defined by nucleotide sequence, falling within the scope
`of the genus or of a recitation of structural features common to the members
`of the genus, which features constitute a substantial portion of the genus,”
`but if a specification “does not define any structural features commonly
`possessed by members of the genus that distinguish [its species] from
`others[,] [o]ne skilled in the art . . . cannot, as one can do with a fully
`described genus, visualize or recognize the identity of the members of the
`genus.” Eli Lilly, 119 F.3d at 1568. Accordingly, “[o]ne needs to show that
`one has truly invented the genus, i.e., that one has conceived and described
`sufficient representative species encompassing the breadth of the genus.
`Otherwise, one has only a research plan, leaving it to others to explore the
`unknown contours of the claimed genus.” AbbVie Deutschland GmbH &
`Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014).
`Regarding obviousness, the Supreme Court in KSR International Co.
`v. Teleflex Inc., 550 U.S. 398 (2007), reaffirmed the framework for
`determining obviousness set forth in Graham v. John Deere Co., 383 U.S. 1
`(1966). The KSR Court summarized the four factual inquiries set forth in
`Graham (383 U.S. at 17–18) that are applied in determining whether a claim
`is unpatentable as obvious under 35 U.S.C. § 103 as follows: (1) determining
`the scope and content of the prior art; (2) ascertaining the differences
`between the prior art and the claims at issue; (3) resolving the level of
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`ordinary skill in the art; and (4) considering objective evidence indicating
`obviousness or non-obviousness, if present.7 KSR, 550 U.S. at 406.
`“[W]hen a patent ‘simply arranges old elements with each performing
`the same function it had been known to perform’ and yields no more than
`one would expect from such an arrangement, the combination is obvious.”
`Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). But
`in analyzing the obviousness of a combination of prior art elements, it can
`also be important to identify a reason that would have prompted one of skill
`in the art “to combine . . . known elements in the fashion claimed by the
`patent at issue.” Id. at 418. A precise teaching directed to the specific subject
`matter of a challenged claim is not necessary to establish obviousness. Id.
`Rather, “any need or problem known in the field of endeavor at the time of
`invention and addressed by the patent can provide a reason for combining
`the elements in the manner claimed.” Id. at 420. Accordingly, a party that
`petitions the Board for a determination of unpatentability based on
`obviousness must show that “a skilled artisan would have been motivated to
`combine the teachings of the prior art references to achieve the claimed
`invention, and that the skilled artisan would have had a reasonable
`expectation of success in doing so.” In re Magnum Oil Tools International,
`Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations
`omitted).
`
`B. Level of Ordinary Skill in the Art
`In determining the level of skill in the art, we consider the type of
`problems encountered in the art, the prior art solutions to those problems, the
`
`
`7 At this stage of the proceeding, there is no evidence pertaining to objective
`indicia of non-obviousness. See Prelim. Resp.
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`rapidity with which innovations are made, the sophistication of the
`technology, and the educational level of active workers in the field. See
`Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962
`(Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d
`1005, 1011 (Fed. Cir. 1983).
`Relying on the testimony of Dr. Clark, Petitioner asserts that
`a person of ordinary skill in the art at all relevant times would
`have had a Ph.D. or master’s degree in chemistry, chemical
`engineering, biochemical engineering, molecular biology, or a
`related technical field, with several years of experience
`studying, developing, or using enzymes such as
`β-galactosidases in industrial processes.
`Pet. 34 (citing Ex. 1002 ¶ 43 (Clark Declaration)); see also id. at 61–62
`(reiterating this definition and indicating “ [t]he level of ordinary skill was
`high and the field was advanced by Novozyme’s earliest possible effective
`filing date in 2019.”); id. at 62 (asserting that skilled artisans had a “high
`level of ordinary skill and creativity”).
`Patent Owner “does not agree that Petitioner’s definition of a POSA is
`correct,” but asserts that “even under Petitioner’s definition, Petitioner’s
`obviousness challenge fails.” Prelim. Resp. 22–23, n.7. At this stage of the
`proceeding, however, Patent Owner neither directly challenges Petitioner’s
`definition of the skilled artisan nor offers an alternative definition. See
`generally id.
`For purposes of this Decision, at this stage of the proceeding, we
`accept Petitioner’s proposed definition of the person of ordinary skill in the
`art, which is not substantively opposed by Patent Owner and appears to be
`consistent with the level of skill in the art reflected in the prior art of record
`and the disclosure of the ’107 patent. See Okajima v. Bourdeau, 261 F.3d
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`1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an
`appropriate level” as evidence of the ordinary level of skill in the art)
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`163 (Fed. Cir. 1985)).
`
`C. Claim Construction
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the
`claim “in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the prosecution
`history pertaining to the patent.” Id. Furthermore, at this stage in the
`proceeding, we need only construe the claims to the extent necessary to
`determine whether to institute inter partes review. See Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017
`(Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy,
`and only to the extent necessary to resolve the controversy.’” (quoting Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`Petitioner proposes that the claim language “transgalactosylating
`activity” should be interpreted “[c]onsistent with the ordinary meaning of
`this term to persons skilled in the art, . . . [which] refer[s] to the transfer of a
`galactose moiety to a molecule other than water to produce
`galactooligosaccharides.” Pet. 34–36 (citing, inter alia, Ex. 1001, 2:11–16,
`2:35–46; Ex. 1002 ¶ 44). Petitioner then contends that “the plain language
`of the claims imposes no limitation on the amount or degree of
`transgalactosylating activity,” and that we should “construe
`‘transgalactosylating activity in the challenged claims to have no limitation
`
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`on the ratio of transgalactosylating activity to lactase (hydrolyzing) activity.”
`Pet. 35. In contrast to this broad assertion, Petitioner further contends that
`the term should be limited to “polypeptides and fragments that are primarily
`transgalactosylating in their activity, including peptides that have high ratios
`of transgalactosylating to lactase (hydrolyzing) activity,” and “result[] in
`lower galactose concentrations compared to glucose. Id. (citing Ex. 1001,
`16:39–18–23, 24:1–57 (italics added). In support of this construction,
`Petitioner relies on the testimony of Dr. Clark, and Patent Owner’s statement
`during prosecution that “its claims and Larsen’s claims requiring a ratio of
`transgalactosylation activity above 150% were ‘directed to the same
`patentable invention.’” Pet. 35–36 (citing Ex. 1002 ¶ 45; Ex. 1012, 4–5).
`In response, Patent Owner “does not concede that Petitioner’s
`proposed constructions are correct,” but offers no alternative construction.
`Prelim. Resp. 7; but see id. at 15 (stating the challenged claims do not
`require “any particular level or ratio of transgalactosylating activity”). Patent
`Owner, nevertheless, contends that, “even under Petitioner’s proposed
`construction, Petitioner fails to demonstrate a reasonable likelihood that any
`of the challenged claims are unpatentable.” Id.
`We do not discern that the Specification accords the term
`“transgalactosylating activity” any special meaning. Its use in the ’541 claim
`language is understandable on its face and neither party argues otherwise.
`Absent evidence to the contrary, we apply the plain and ordinary meaning as
`understood by one of ordinary skill in the art. Moreover, as our institution
`decision does not turn on whether one of ordinary skill would understand
`that the claims are limited to polypeptides having primarily
`transgalactosylating activity, we decline to address here that portion of
`
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`Petitioner’s proposed construction. See Vivid Techs., 200 F.3d at 803
`(“[O]nly those terms need be construed that are in controversy, and only to
`the extent necessary to resolve the controversy.”).
`
`D. Analysis of Ground 1
`As its sole Ground of unpatentability, Petitioner contends claims 1, 3–
`9, and 11–17 would have been obvious in view of Larsen. Pet. 54–69.
`Petitioner admits that Larsen was published on August 13, 2015—long after
`the earliest possible priority date of the ’541 Patent. See Pet. 26; Ex. 1001,
`code (60), (63). Petitioner, nevertheless, contends that Larsen qualifies as
`prior art because the challenged claims are not entitled to an effective filing
`date earlier than the April 10, 2019 because the earlier-filed applications
`lack written description support for the challenged claims. See Pet. 36.
`Patent Owner argues that the challenged claims are entitled to a filing date of
`at least the December 2, 2008 filing of the ’624 PCT application such that
`Larsen does not qualify as prior art. See, e.g., Prelim. Resp. 3–4, n.2, 10.
`We address, first, the threshold issue of whether the challenged claims
`are entitled to an effective filing date such that Larsen qualifies as prior art.
`
`Entitlement to Priority / Whether Larsen Qualifies as Prior Art
`1)
`Petitioner contends that the challenged claims are not entitled to an
`effective filing date earlier than the April 10, 2019, filing of the ’220
`application, from which the ’541 Patent issued. Pet. 36–54. Accordingly,
`Petitioner reasons, Larsen, published on August 13, 2015, qualifies as prior
`art. Id. at 54.8
`
`
`8 Larsen is the published version of U.S. Application 14/405,072, filed on
`June 7, 2013, which ultimately issued on January 14, 2020 as US Patent
`
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`
`As articulated in Ariad, “an adequate written description requires a
`precise definition, such as by structure, formula, chemical name, physical
`properties, or other properties, of species falling within the genus sufficient
`to distinguish the genus from other materials.” Ariad, 598 F.3d at 1350
`(citations omitted). One test of whether a claimed genus finds adequate
`support involves identifying in the specification “either a representative
`number of species falling within the scope of the genus or structural features
`common to the members of the genus so that one of skill in the art can
`‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350
`(citing Eli Lilly, 119 F.3d at 1568–69). Addressing Patent Owner’s ’508
`application as representative, Petitioner argues that none of the ’541 Patent’s
`priority applications satisfy this test. Pet. 39.9 More particularly, Petitioner
`asserts that although the earlier-filed applications “acknowledge[] the
`possibility that lactases may have other activities such as trans-
`galactosylating activity, their “examples repeatedly tested a polypeptide
`having no transgalactosylating activity” and never identified “any structural
`information to distinguish lactases that may have transgalactosylating
`activity from those that would not.” Id. at 40–41, 45–46 (citing Ex. 1002
`¶¶ 54–58, 48–53, 60, 63; Ex. 1015, 2:17–19, 2:23–30, 7:12–13, 15:31–33,
`21:8–10, 23:10–14, 24:13–17, 33:3–7).
`
`
`10,531,672 B2. Ex. 1003, codes (43), (21), (22). Ex. 2001, 1 (issue
`notification from prosecution history).
`9 In discussing written description support, Petitioner focuses on the ’508
`application, whereas Patent Owner cites to the ’624 PCT. See e.g., Pet. 38,
`n.3; Prelim. Resp. 19. Because both applications predate Larson and share
`substantially the same disclosure, we consider them equivalent for the
`purpose of this section and refer to them, collectively, as “the earlier-filed
`applications.”
`
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`
`In response, Patent Owner contends that the two-prong Ariad test is
`inapplicable because “the ’541 Patent claims are not directed to a genus
`described solely by function as in Ariad and Eli Lilly,” and points, instead, to
`broader articulations requiring the specification “convey with reasonable
`clarity to those skilled in
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