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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`JENNEWEIN BIOTECHNOLOGIE GmbH,
`Petitioner,
`
`v.
`
`GLYCOSYN LLC,
`Patent Owner.
`
`
`Case PGR2019-00023
`U.S. Patent No. 9,970,018
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107(a)
`
`
`
`

`

`TABLE OF CONTENTS
`
`Case No. PGR2019-00023
`Patent No. 9,970,018
`
`
`Page(s)
`
`I.
`
`II.
`
`A.
`
`B.
`
`C.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND OF THE INVENTION ....................................................... 3
`
`The ’018 Patent ............................................................................................ 3
`
`Overview of the Claimed Technology Relevant to the Petition .................. 5
`
`Claim Construction ...................................................................................... 8
`
`D. Admissions Made by Petitioner’s Expert at Deposition in Related ITC
`Proceedings .................................................................................................. 9
`
`III. ARGUMENT ................................................................................................. 12
`
`A.
`
`B.
`
`C.
`
`The ’018 Patent is not PGR eligible. ......................................................... 12
`
`The Board should exercise its discretion under Section 325(d) to decline
`institution of the Petition. .......................................................................... 14
`
`Petitioner has failed to show a reasonable likelihood that one or more
`claims of the ’018 Patent are invalid. ........................................................ 17
`
`1. Jennewein fails to establish any reason why a POSA could not practice
`the claims of the ’018 Patent in light of Dr. McCoy’s declaration. ...... 18
`
`2. The claims of the ’018 Patent are enabled for the entire claimed range of
`β-galactosidase activity.......................................................................... 22
`
`3. None of the Wands Factors supports a lack of enablement. ...................... 29
`
`a. Wands Factor 1 ...................................................................................... 30
`
`b. Wands Factors 2 and 3 ........................................................................... 31
`
`c. Wands Factor 4 ...................................................................................... 33
`
`d. Wands Factors 5, 6, and 7 ...................................................................... 34
`
`e. Wands Factor 8 ...................................................................................... 35
`
`4. The claims of the ’018 Patent are not indefinite. ...................................... 36
`
`a. Claims 1-28 of the ’018 Patent are not indefinite for failing to specify
`how to measure β-galactosidase activity. .......................................... 37
`
`b. Claims 1-28 of the ’018 Patent are not indefinite for reciting that the
`activity level “comprises” a range. .................................................... 41
`
`IV. CONCLUSION .............................................................................................. 42
`
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`Case No. PGR2019-00023
`Patent No. 9,970,018
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`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Federal Cases
`
`Becton, Dickinson and Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ......................................... 16-17
`
`Chiron Corp. v. Genentech Inc.,
`363 F.3d 1247 (Fed. Cir. 2004) .......................................................................... 26
`
`Elbit Sys. of Am., LLC v. Thales Visionix, Inc.,
`881 F.3d 1354 (Fed. Cir. 2018) .......................................................................... 31
`
`Fox Factory Inc. v. SRAM LLC,
`PGR2016-00043, Paper 9 (PTAB Apr. 3, 2017) .......................................... 20, 25
`
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .......................................................................... 14
`
`Hospira, Inc. v. Genentech, Inc.,
`Case IPR2017-00739, slip op. (PTAB July 27, 2017).................................. 14-15
`
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1998) .....................................................................passim
`
`Inguran LLC v. Premium Genetics (UK) Ltd.,
`PGR 2015-00017 (PTAB Dec. 22, 2015) ........................................................... 13
`
`Kayak Software Corp.v. International Business Machines Corp.,
`CBM2016-00075, Paper 16 (PTAB Dec. 15, 2016)........................................... 16
`
`United States Steel Corp. v. Phillips Petroleum Co.,
`865 F.2d 1247 (Fed. Cir. 1989) .......................................................................... 26
`
`Velander v. Garner,
`348 F.3d 1359 (Fed. Cir. 2003) .......................................................................... 20
`
`Federal Statutes
`
`35 U.S.C. § 314(a) ................................................................................................... 14
`
`35 U.S.C. § 325(d) ......................................................................................... 2, 14, 17
`
`America Invents Act, 125 Stat. 284, 311 § 6(f)(2)(A) (2011) ........................... 12-13
`
`Regulations
`
`37 C.F.R. § 42.65 ..................................................................................................... 20
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`Patent No. 9,970,018
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`37 C.F.R. § 42.200(b) .............................................................................................. 37
`
`37 C.F.R. § 42.204(a) ............................................................................................... 13
`
`Other Authorities
`
`MPEP § 2164.05(a) .................................................................................................. 26
`
`MPEP § 2111.03 ...................................................................................................... 41
`
`
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`Case No. PGR2019-00023
`Patent No. 9,970,018
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`
`TABLE OF EXHIBITS
`
`Description
`
`Certain Human Milk Oligosaccharides, Inv. No. 337-TA-1120, Order
`No. 22 (Dec. 18, 2018)
`Excerpts of the December 14, 2018 Deposition Transcript of Dr.
`Gregory Stephanopoulos in ITC Proceeding No. 337-TA-1120.
`Court, D.L., et al., Genetic engineering using homologous
`recombination. Annual review of genetics 36.1 (2002): 361-388.
`Thomason, L., et al., E. coli genome manipulation by P1
`transduction. Current protocols in molecular biology 79.1 (2007): 1-
`17.
`Reply to communication from the Examining Division in Foreign
`Counterpart EP2675899 (Dec. 11, 2017)
`U.S. Patent No. 8,110,672
`Taylor, R., Interpretation of the correlation coefficient: a basic
`review. Journal of diagnostic medical sonography, 6(1), (1990) pp.
`35-39.
`
`Exhibit
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
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`2006
`2007
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`
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`Case No. PGR2019-00023
`Patent No. 9,970,018
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`
`I.
`
`INTRODUCTION
`
`Two things are not apparent from the Petition for Post-Grant Review brought
`
`by Jennewein Biotecchnologie GmbH. Both relate to a parallel investigation
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`regarding the subject patent, U.S. Patent No. 9,970,018, at the International Trade
`
`Commission (“ITC”). The first is that the same expert used by Jennewein to support
`
`the Petition made statements during his deposition in the ITC proceeding which
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`severely undermine all of the arguments made in the Petition. The second is that
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`just a week after the Petition was filed, an Administrative Law Judge at the ITC
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`issued a claim construction ruling regarding claim terms relevant to the Petition,
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`including a finding that all claims of the ’018 Patent are not indefinite.
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`Jennewein makes two arguments in its Petition: lack of enablement and
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`indefiniteness. It needs the lack of enablement argument for standing, because the
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`’018 Patent bears a 2011 priority date on its face and thus is presumptively not
`
`eligible for PGR review. It needs the indefiniteness argument to try and invalidate
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`claims that its own expert has admitted are enabled. Both arguments fail.
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`On enablement, the only issue is whether the portion of the claims directed to
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`a range of enzyme activity (here, a range between 0.05 and 200 units of β-
`
`galactosidase activity) are sufficiently enabled across the range. Petitioner’s expert
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`has already admitted under oath that the lower end of the claimed range (i.e., from
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`0.05-5 units) is enabled. That leaves only the high end of the range (i.e., up to 200
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`units) up for debate. But this high end of the range is precisely what the examiner
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`scrutinized during prosecution, and precisely what the applicant overcame by filing
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`an inventor declaration supported by additional data. In other words, the enablement
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`challenge is simply a rehash of arguments already considered by the Office and
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`overcome during prosecution. Petitioner supplies no new evidence calling the
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`reasoning of the examiner, or the sufficiency of the enabling data submitted by the
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`inventor, into question. The Board should either decline to exercise its discretion to
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`take up the Petition under 35 U.S.C. § 325(d), or reject the enablement challenge
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`outright (which of course would render the ’018 Patent ineligible for PGR review).
`
`On indefiniteness, the same two arguments made in the Petition were also
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`made at the ITC, and the claims of the ’018 Patent were found to be not indefinite.
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`Moreover, the primary thrust of Petitioner’s argument is that the so-called “Miller
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`assay,” which is a common assay used to measure β-galactosidase activity and is
`
`expressly incorporated into the ’018 Patent, could not be reliably performed by
`
`persons of ordinary skill in the art at the time of the invention. Not only did the ITC
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`reject this argument in its recent ruling, but also Jennewein’s expert has so little
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`familiarity with the Miller assay so as to render his opinions on the topic
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`meaningless.
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`In sum, there is no reason the Board should revisit issues that have already
`
`been decided by the Patent Office (enablement) or the ITC (indefiniteness),
`
`especially not based on an expert declaration that is both conclusory and not credible.
`
`II. BACKGROUND OF THE INVENTION
`
`A. The ’018 Patent
`
`The ’018 Patent is entitled “Biosynthesis of Human Milk Oligosaccharides in
`
`Engineered Bacteria.” See Ex. 1001. It was filed on September 21, 2017 and issued
`
`on May 15, 2018 with 28 claims. The ’018 Patent is a continuation of Application
`
`No. 14/442,131, filed on February 24, 2017, which is a continuation of Application
`
`No. 14/033,664, filed on September 23, 2013, which is a divisional of Application
`
`No. 13/398,526, filed February 16, 2012 (issued as U.S. Patent No. 9,453,230),
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`which claims priority to provisional Application No. 61/442,470, filed February 16,
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`2011. See id. at 1:7-16.
`
`The patented invention relates to “compositions and methods for producing
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`purified oligosaccharides, in particular certain fucosylated and/or sialylated
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`oligosaccharides that are typically found in human milk.” Id. at 1:27-30. Human
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`Milk Oligosaccharides (“HMOs”) are oligosaccharides that are found in high
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`concentrations in human breast milk. Id. at 1:34-36. Approximately 200 structurally
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`distinct HMOs have been identified. Id. at 13:57-65. Most of these HMOs cannot
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`be processed directly by an infant as nutrition, “but they nevertheless serve critical
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`roles in the establishment of a healthy gut microbiome, in the prevention of disease,
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`and in immune function.” Id. at 1:37-39. Prior art methods such as chemical or
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`enzymatic synthesis exist to produce HMOs, but each has suffered from and been
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`limited by scalability issues. Id. at 1:34-47, 53-65. The ’018 Patent overcomes the
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`shortcomings of prior methods by allowing for the cost-effective production of
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`HMOs. Id. at 15:59-16:4.
`
`The claims of the ’018 Patent are directed to methods of using specifically
`
`engineered E. coli bacteria to produce HMOs. See id. at 2:28-31 (“The invention
`
`described herein details the manipulation of genes and pathways within bacteria such
`
`as the enterobacterium Escherichia coli K12 (E. coli) or probiotic bacteria leading
`
`to high level synthesis of HMOS.”). Claim 1, the only independent claim, is more
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`specifically directed to the production of “fucosylated” HMOs:
`
`1. A method for producing a fucosylated oligosaccharide in a
`
`bacterium, comprising
`
`providing an isolated E. coli bacterium comprising,
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`(i) a deletion or functional inactivation of an endogenous β-
`
`galactosidase gene;
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`(ii) an exogenous functional β-galactosidase gene comprising a
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`detectable level of β-galactosidase activity that is reduced compared to
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`that of a wild-type E. coli bacterium, wherein the level of β-
`
`galactosidase activity comprises between 0.05 and 200 units;
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`(iii) an inactivating mutation in a colanic acid synthesis gene; and
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`an exogenous lactose-accepting fucosyltransferase gene;
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`(iv) culturing said bacterium in the presence of lactose; and
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`retrieving a fucosylated oligosaccharide from said bacterium or from a
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`culture supernatant of said bacterium.
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`Id. at 111:41-57.
`
`Approximately 70-80% of HMOs are fucosylated. Id. at 14:7-8. These
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`fucosylated HMOs have been shown to provide particular benefits to infant health.
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`Id. at 14:38-60. The trisaccharide 2ʹ-fucosyllactose (“2ʹ-FL”) is an example of a
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`fucosylated HMO. Id. at 16:6-22:15 (Examples 1-4 discussing 2ʹ-FL production).
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`B. Overview of the Claimed Technology Relevant to the Petition
`
`Petitioner challenges two aspects of the ’018 Patent claims. First, Petitioner
`
`argues that the levels of bacterial β-galactosidase activity claimed in claim 1—
`
`namely, between 0.05 and 200 “units”—are not enabled. Second, Petitioner argues
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`that the units used to measure β-galactosidase activity—namely, “Miller units”—are
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`indefinite. Thus, a brief discussion of the scientific relevance of β-galactosidase
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`activity and Miller units to the challenged claims is appropriate.
`
`The ’018 Patent teaches those skilled in the art how to engineer a bacterium
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`to produce certain fucosylated HMOs, such as 2ʹ-FL. Figure 3 of the patent provides
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`a schematic demonstrating certain metabolic pathways and the modifications made
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`to cause those pathways to synthesize 2ꞌ -FL in E. coli:
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`Ex. 1001 at 12:20-30.
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`In order to make 2ʹ-FL, a bacterium requires (1) lactose, (2) GDP-fucose, and
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`(3) a fucosyltransferase enzyme (indicated above as “α(1,2)FT”). However, E. coli
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`bacteria naturally produce β-galactosidase, a well-known enzyme that digests
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`lactose into its constituent parts (glucose + galactose). See generally, id. Because
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`lactose is required to produce 2ʹ-FL, the ’018 Patent describes a way to prevent
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`normal, high levels of β-galactosidase from depleting the lactose. To accomplish
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`this, the inventors deleted or functionally inactivated the endogenous lacZ gene
`
`(which is responsible for producing β-galactosidase) and replaced it with a modified
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`construct capable of producing a “low but readily detectable level of β-galactosidase
`
`activity.” Id. at 5:61-6:12; 111:44-50. The patent’s surprising discovery is that
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`“[t]his low level of cytoplasmic β-galactosidase activity, while not high enough to
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`significantly diminish the intracellular lactose pool, is nevertheless very useful for
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`tasks such as phenotypic marking of desirable genetic loci during construction of
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`host cell backgrounds, for detection of cell lysis due to undesired bacteriophage
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`contaminations in fermentation processes, or for the facile removal of undesired
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`residual lactose at the end of fermentations.” Id. at 7:37-45.
`
`The ’018 Patent further discloses specific ranges of such “low levels” of β-
`
`galactosidase activity, and how they are to be measured:
`
`Low, functional levels of cytoplasmic β-galactosidase include β-
`
`galactosidase activity levels, of between 0.05 and 200 units, e.g.,
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`between 0.05 and 5 units, between 0.05 and 4 units, between 0.05 and
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`3 units, or between 0.05 and 2 units (for unit definition see: Miller J H,
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`Laboratory CSH. Experiments in molecular genetics. Cold Spring
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`Harbor Laboratory Cold Spring Harbor, N.Y.; 1972; incorporated
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`herein by reference).
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`Id. at 7:30-37. Thus, the patent expressly incorporates by reference a 1972
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`publication by Miller to obtain the “units” of enzyme activity. See Ex. 1009 at 352
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`(“β-galactosidase is an enzyme which hydrolyzes β-D-galactosides. It can easily be
`
`measured with chromogenic substrates, colorless substrates which are hydrolyzed to
`
`yield colored products.”); see also Ex. 1010 at 87 (“Among the different methods
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`commonly used to measure β-galactosidase activity, the assay proposed by Miller is
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`one of the most popular, due to its simple procedure based on bacterial cell
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`permeabilization followed by spectrophotometrical measurement . . . .”).
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`The 1972 Miller reference provides a stepwise protocol for conducting a β-
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`galactosidase enzyme activity assay, and the resulting units are known as “Miller
`
`units.” See Ex. 1001 at 7:34-37; Ex. 1009 at 353-354 (describing the Miller
`
`“materials,” “method,” and a “sample calculation”).
`
`C. Claim Construction
`
`Claim construction of the ’018 Patent has already occurred in the co-pending
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`ITC proceeding, and the Administrative Law Judge presiding over the ITC
`
`proceeding issued a claim construction order on December 18, 2018. See Ex. 2001.
`
`Many of the constructions in the ITC’s order are not relevant to the instant Petition.
`
`However, one construction is highly relevant. The ITC construed the claim term “β-
`
`galactosidase activity comprises between 0.05 and [200 units / 5 units / 4 units / 3
`
`units / 2 units]” as follows:
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`β-galactosidase activity comprises between 0.05 and [200 units / 5 units
`
`/ 4 units / 3 units / 2 units]” is hereby not found to be indefinite and
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`construed as “β-galactosidase activity is measurable at between
`
`exactly 0.05 and exactly [200/5/4/3/2] Miller Units, as defined in
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`Miller, J.H., Experiments in Molecular Genetics (Cold Spring
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`Harbor Lab. 1972) at 352-355.
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`Id. at 22-23 (emphasis in original).
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`The Board does not need to provide any new constructions and should instead
`
`adopt those set forth in the ITC’s order, as necessary.
`
`D. Admissions Made by Petitioner’s Expert at Deposition in Related
`ITC Proceedings
`
`The Petition is supported by the expert declaration of Dr. George
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`Stephanopoulos. See Ex. 1017. Dr. Stephanopoulos is the same expert that the
`
`Petitioner, Jennewein, has used in support of its case in the parallel ITC proceedings
`
`involving the same ’018 Patent. Dr. Stephanopoulos was deposed in the ITC
`
`proceedings on December 14, 2018, and an excerpt of the transcript of that
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`deposition is provided as Exhibit 2002 hereto. During his deposition, Dr.
`
`Stephanopoulos made several admissions under oath that cannot be squared with the
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`positions that he and Jennewein are now taking in his declaration and this Petition.
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`Many of Dr. Stephanopoulos’ admissions will be discussed throughout this
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`Preliminary Response, but two deserve mention at the outset because they directly
`
`undermine the key arguments that Jennewein attempts to make in its Petition.
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`First, when questioned about the claimed β-galactosidase activity range at his
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`ITC deposition, Dr. Stephanopoulos acknowledged unequivocally that the lower
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`portion of the range from 0.05 to 5 units was enabled:
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`Ex. 2002 at 220:3-221:2.
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`Second, when questioned about the “Miller test” or “Miller assay”—the test
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`most commonly used to measure β-galactosidase activity, and which is expressly
`
`incorporated by reference in the specification and claims of the ’018 patent—Dr.
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`Stephanopoulos
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`Id. at 42:1-43:4.
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`Even after having reviewed the Miller assay for purposes of his testimony in
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`the ITC litigation, Dr. Stephanopoulos did not grasp important aspects of the assay
`
`protocol. For example, the Miller assay relies on the use of a cell permeabilizing
`
`agent to allow a substrate to penetrate into cells, react with β-galactosidase enzyme
`
`in the cells, and then produce a fluorescent reaction product that can be measured
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`spectrophotometrically. See Ex. 1009 (Miller 1972), at 352; see also Ex. 1010
`
`(Giacomini) at 87 (“Among the different methods commonly used to measure β-
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`galactosidase activity, the assay proposed by Miller is one of the most popular, due
`
`to its simple procedure based on bacterial cell permeabilization followed by
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`spectrophotometrical measurement of o-nitrophenol released from its galactoside
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`conjugate (o-nitrophenyl-β-D-galactoside, ONPG)”). The cell permeabilizing agent
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`can be either toluene or chloroform. See Ex. 1009 at 353 (“The toluene partially
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`disrupts the cell membrane, allowing small molecules, such as ONPG, to diffuse into
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`the cell.”); id. at 355 (“As an alternative to the toluene method, 2 drops of chloroform
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`and 1 drop of 0.1% SDS solution are added to each ml of assay mix.”).
`
`Dr. Stephanopoulos testified, however, that the Miller assay relies on cell
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`lysis. See, e.g., Ex. 2002 at 129:9-11 (“You take the cells in a small cuvette, you
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`lyse them, and you will follow the protocol prescribed by Miller.”); id. at 156:19-23
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`(“Q: And then you add either toluene or SDS chloroform? A: Yes. Q: And that is
`
`what lyses the cells? A: Yes.”). Cell lysis (rupturing the cell membrane) is
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`completely different from cell permeabilization (opening small gaps in the cell
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`membrane for small molecules to pass through). Cell lysis has nothing to do with
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`the Miller assay, see Ex. 1009, and yet Dr. Stephanopoulos seemed to think that it
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`does. Dr. Stephanopoulos’s testimony about the Miller assay as it relates to the
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`Petition is therefore dubious at best.
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`III. ARGUMENT
`
`A. The ’018 Patent is not PGR eligible.
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`Jennewein admits that in order to be eligible for post-grant review, “a
`
`challenged patent must be subject to the first-inventor-to-file provisions of the
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`America Invents Act (AIA).” Petition at 22 (citing AIA § 6(f)(2)(A), 125 Stat. 284,
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`311 (2011)). Jennewein further admits that the first-inventor-to-file provisions apply
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`only to patents with an effective filing date on or after March 16, 2013. Id. (citing §
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`3(n)(1), 125 Stat. at 203). On its face, the ’018 Patent has a February 16, 2011,
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`priority date and is presumptively not PGR eligible. Ex. 1001 at 1. As the petitioner,
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`Jennewein bears the burden to demonstrate otherwise. See Inguran LLC v. Premium
`
`Genetics (UK) Ltd., PGR 2015-00017 at 8-9, Paper No. 8 (PTAB Dec. 22, 2015);
`
`see also 37 C.F.R. § 42.204(a).
`
`Notably, Jennewein did not challenge the ’018 patent’s priority date in the
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`ITC proceedings. Now, however, Jennewein attempts to meet its burden by arguing
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`that some of the claims of the ’018 Patent are not entitled to a 2011 priority date due
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`to a lack of enablement. Petition at 21-22. Jennewein presses this enablement angle
`
`for PGR eligibility despite its own expert’s admission during the related ITC
`
`proceeding that many of the claims of ’018 Patent claims—specifically, those
`
`reciting β-galactosidase activity between .05 and 5 units or less—are enabled. See
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`Petition at 9-10; see also id. at 2, 21. Thus, Petitioner’s standing for this PGR rests
`
`on the thin reed that despite admissions from its own expert that many of the ’018
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`Patent claims are enabled, certain other claims, with very similar claim language,
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`are not enabled. As discussed further in Section C below, this is not a colorable lack
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`of enablement challenge. The ’018 Patent is therefore not eligible for PGR review.
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`37 C.F.R. § 42.204(a).
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`B.
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`The Board should exercise its discretion under Section 325(d) to
`decline institution of the Petition.
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`The Board’s institution of a post-grant review is discretionary. See Harmonic
`
`Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (explaining that under
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`35 U.S.C. § 314(a), “the PTO is permitted, but never compelled, to institute a []
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`proceeding”). 35 U.S.C. § 325(d) expressly grants the Board authority to deny a
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`petition that merely repeats arguments that were already considered and rejected at
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`the Patent Office. See Hospira, Inc. v. Genentech, Inc., Case IPR2017-00739, slip
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`op. at 17-18, Paper No. 16 (PTAB July 27, 2017). The Board’s evaluation of a
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`petition in light of § 325(d) should account for numerous factors as articulated in the
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`informative Hospira decision:
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`The Board’s discretion under § 325(d) involves a balance between
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`several competing interests. See Neil Ziegman, N.P.Z., Inc. v. Stephens,
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`Case IPR2015-01860, slip op. at 12–13, Paper No. 11 (PTAB Feb. 24,
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`2016) (“While petitioners may have sound reasons for raising art or
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`arguments similar to those previously considered by the Office, the
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`Board weighs petitioners’ desires to be heard against the interests of
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`patent owners, who seek to avoid harassment and enjoy quiet title to
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`their rights.”) (citing H. Rep. No. 112-98, pt. 1, at 48 (2011)). “On the
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`one hand, there are the interests in conserving the resources of the
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`Office and granting patent owners repose on issues and prior art that
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`have been considered previously.” Fox Factory, Inc. v. SRAM, LLC,
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`Case IPR2016-01876, slip op. 7, Paper No. 8 (PTAB Apr. 3, 2017).
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`Case No. PGR2019-00023
`Patent No. 9,970,018
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`“On the other hand, there are the interests of giving petitioners the
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`opportunity to be heard and correcting any errors by the Office in
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`allowing a patent—in the case of an inter partes review—over prior art
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`patents and printed publications.” Id.
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`IPR2017-00739, slip op. at 18, Paper No. 16 (PTAB Jul. 27, 2017). All of these
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`factors favor the Board exercising its discretion to deny the instant Petition.
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`Petitioner’s enablement challenge is not new. It rehashes precisely the same
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`positions and arguments made by the Patent Office during the prosecution of the
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`’018 Patent family, including the related parent patent, U.S. Patent No. 9,453,230
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`(the “’230 patent”). See Petition at 13 (“[M]uch occurred during prosecution of the
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`patent’s great-grandparent that informs the issues here.”). As the Petition concedes,
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`the same examiner for both the ’018 Patent and ’230 Patent considered the very same
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`enablement arguments presented in the Petition and ultimately concluded that the
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`claims terms at issue were enabled and patentable. See, e.g., id. at 19 (“Presumably
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`to address the same enablement issues with the same claim limitation of ‘between
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`0.05 and 200 units’ of β-galactosidase activity, Examiner Prouty required the Patent
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`Owner to submit the Second McCoy Declaration in the ’018 Patent’s prosecution
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`history.”) (emphasis added).
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`For more than two years between December 4, 2013 and May 13, 2016, the
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`Patent Owner faced four office actions rejecting these same β-galactosidase activity
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`unit claim limitations on enablement grounds. See Petition at Secs. III(C)(1-5).
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`Case No. PGR2019-00023
`Patent No. 9,970,018
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`After these rejections, the Patent Owner submitted a declaration from Dr. John M.
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`McCoy, one of the inventors. Dr. McCoy showed, based on experimental data, that
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`the entire range of 0.05 to 200 units of β-galactosidase activity was enabled. Ex.
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`1004 at 1328-32. As the Examiner noted in the Notice of Allowance:
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`The declaration of Dr. John McCoy establishes that there is a
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`reasonable expectation that microorganisms as claimed with up to
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`200 units of β-galactosidase activity will still produce useful amounts
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`of fucosylated oligosaccharides from lactose and applicants have
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`pointed to page 23, line 28 as providing support for claim 74 such that
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`the rejections of the claims under 112, 1st paragraph are withdrawn.
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`Id. at 1340 (emphasis added).
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`Petitioner does not assert that there were any errors made by the examiner
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`during her evaluation of the enablement issues. That is in stark contrast to other
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`cases where issues evaluated during prosecution were revisited in a post-grant
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`proceeding. See Kayak Software Corp. v. International Business Machines Corp.,
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`CBM2016-00075, at 11, Paper No. 16 (PTAB Dec. 15, 2016) (noting that similarity
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`with the prosecution record might not be enough to invoke 325(d) where “there are
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`clear errors in the original prosecution”); see also Becton, Dickinson and Co. v. B.
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`Braun Melsungen AG, IPR2017-01586, at 18, Paper No. 8 (PTAB Dec. 15, 2017)
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`(setting forth factors for evaluating similar prior art presented in a petition including
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`16
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`Case No. PGR2019-00023
`Patent No. 9,970,018
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`whether Petitioner has pointed out sufficiently how the Examiner erred in its
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`evaluation of the asserted prior art).
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`In fact, Petitioner praises the work of the examiner during prosecution and
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`points out how thoroughly she considered the issues surrounding enablement. See,
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`e.g., Petition at 28 (“Petitioner’s expert agrees with Examiner Prouty’s analysis.”);
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`see also generally id. at 13-19. Petitioner notes that the examiner’s consideration of
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`enablement spanned four office actions over more than two years. Id. Petitioner
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`concedes that the examiner wwithdrew her enablement rejection and allowed the
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`’230 patent claims to issue. Id. at 19 (citing Ex. 1004 at 1333-41).
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`Petitioner has come forward with no new evidence to support its request that
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`the Board revisit the same issue to which the examiner gave extensive consideration.
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`In sum, the Board should exercise its discretion to decline the Petition under § 325(d)
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`because the very same non-enablement arguments were previously presented to the
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`Office and resolved during prosecution.
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`C.
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`Petitioner has failed to show a reasonable likelihood that one or
`more claims of the ’018 Patent are invalid.
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`Even if the Board chooses not to invoke § 325(d), the Board should
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`nevertheless deny institution because Petitioner has failed to show that there is a
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`reasonable likelihood that one or more claims of the ’018 Patent are invalid.
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`Petitioner’s expert has already admitted under oath that most of the claimed range
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`Case No. PGR2019-00023
`Patent No. 9,970,018
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`of .05-200 units of β-galactosidase activity is enabled, leaving only the high end of
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`the range (200 units) at issue. But this high end of the range was carefully vetted
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`during prosecution, and Petitioner supplies no new or credible data calling that
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`decision, or the enablement data submitted by the inventor, into question.
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`Petitioner’s enablement challenge is thus without merit. As for Petitioner’s
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`indefiniteness challenge, it has already been resolved in Patent Owner’s favor by an
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`Administrative Law Judge of the ITC during related litigation involving the same
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`’018 Patent.
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`1.
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`Jennewein fails to establish any reason why a POSA could
`not practice the claims of the ’018 Patent in light of Dr.
`McCoy’s declaration.
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`Claim 1 of the ’018 Patent recites a range of β-galactosidase activity between
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`0.05 and 200 units. Jennewein does not challenge enablement of the lower or middle
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`portions of this range, nor could it. Jennewein’s own expert has already admitted,
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`under oath, that claims directed to β-galactosidase activity between 0.05 and 5 units,
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`0.05 and 4 units, 0.05 and 3 units, and 0.05 and 2 units, are enabled. See Petition at
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`9-10. Thus, Jennewein’s only challenge is to the upper end of the range, 200 units.
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`Yet this upper end of the range is exactly what was at issue and overcome during
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`prosecution.
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`As explained above, the applicants ultimately supported the enablement of the
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`200 units range with an inventor declaration from Dr.