Danisco U.S. Inc. v. Novozymes North America, Inc., IPR2020-00464

• Decision Date: 20 July 2021
• Docket Number: 820,419 B2,IPR2020-00464,Patent 7
• Parties: DANISCO U.S. INC., Petitioner, v. NOVOZYMES NORTH AMERICA, INC., Patent Owner.
• Court: Patent Trial and Appeal Board

DANISCO U.S. INC., Petitioner, v. NOVOZYMES NORTH AMERICA, INC., Patent Owner.

IPR2020-00464

Patent 7, 820, 419 B2

United States Patent and Trademark Office, Patent Trial and Appeal Board

July 20, 2021

For PETITIONER: Michael J. Flibbert Pier D. DeRoo Olivia Martzahn FiNNEGAN, Henderson, Farabow, Garrett & Dunner, LLP

For PATENT OWNER: Jeffrey P. Kushan Lauren Cranford Katzeff SiDLEY Austin LLP

Before GRACE KARAFFA OBERMANN, ROBERT A. POLLOCK, and RYAN H. FLAX Administrative Patent Judges.

JUDGMENT

FLAX Administrative Patent Judge.

Final Written Decision Determining All Challenged Claims Unpatentable

35 U.S.C. § 318(a)

I. INTRODUCTION

Danisco U.S. Inc. ("Petitioner") filed a Petition for an inter partes review of claims 1-9, 11, and 13-19 of U.S. Patent 7, 820, 419 B2 ("the '419 patent," Ex. 1001). Paper 1 ("Pet."). Novozymes North America, Inc. ("Patent Owner") filed a Response.^[1] Paper 19 ("Resp."). Petitioner filed a Reply to Patent Owner's Response ("Reply," Paper 25) and Patent Owner filed a Sur-Reply ("Sur-Reply," Paper 33). A final hearing was held on April 27, 2021, at which the parties presented oral argument. See Paper 40 ("Hr'gTr.").

We have authority under 35 U.S.C. § 6. Petitioner bears the burden of proving unpatentability of the challenged claims and the burden of persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat V Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must prove unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. After considering the parties' arguments and supporting evidence, we conclude that Petitioner has proven by a preponderance of the evidence that claims 1-9, 11, and 13-19 of the '419 patent are unpatentable. 35 U.S.C. § 316(e).

A. Real Parties-in-Interest

Petitioner identifies itself, "Danisco U.S. Inc.," and "International Flavors & Fragrances Inc." as the real parties-in-interest. Paper 24. Patent Owner identifies itself, "Novozymes North America, Inc.," as the real party-in-interest. Paper 5.

B. Related Matters

The parties identify "Novozymes North America, Inc. v. Danisco U.S. Inc. & DuPont Nutrition & Biosciences, No. 19-1902 (D. Del. filed Oct. 8, 2019)" as a related matter. Pet. 4; Paper 5.

C. The '419 Patent

The '419 patent issued on October 26, 2010, from Application 11/814, 304, which was filed on February 7, 2006, and claims priority to U.S. Provisional Application 60/651, 001, filed on February 8, 2005. Ex. 1001, codes (45), (21), (22), (60). The '419 patent's Abstract states:

The present invention relates to a process for producing a fermentation product from starch-containing material, comprising liquefying said starch-containing material with an alpha-amylase; treating with a protease; saccharifying in the presence of a carbohydrate-source generating enzyme; fermenting in the presence of a fermenting organism.

Id. at Abstract.^{[2] [3]} The Specification further explains that

[t]ypically ethanol is produced by liquefying starch-containing material followed by sequential or simultaneous saccharification and fermentation. Liquefaction involves gelatinization of starch simultaneously with or followed by addition of alpha-amylase in order to degrade starch into dextrins. When producing ethanol the liquefied starch-containing material is saccharified. Saccharification is a step in which dextrins are converted to low molecular DP_1-3 sugars that, e.g., can be converted by a yeast into ethanol [via fermentation].

Id. at 144-52. The Specification further explains that, in the prior art, it was known to introduce a protease to the liquefied mash produced by the liquefaction step during the saccharification and/or fermentation steps. Id. at 1:53-24. Fermenting is a process step where a fermenting organism, e.g., yeast, produces alcohol, e.g., ethanol, from the saccharified liquefied mash. Id. at 1:23-35, 2:18, 6:1-8. The Specification explains that adding protease during the ethanol production process in such a way results in increased amino nitrogen and, thereby, accelerates the rate of ethanol fermentation, increases ethanol production and productivity, and lowers glycerol production (which is an undesirable by-product and indicates lower ethanol yield). Id. at 2:1-4, 3:7-21.

The '419 patent describes that "[l]iquefaction is a process step in which starch-containing material, preferably milled (whole) grain, is broken down (hydrolyzed) into maltodextrins (dextrins). Liquefaction is typically carried out using an a-amylase or by other means known in the art to provide such effect (e.g., acid hydrolysis)." Id. at 4:3-8. The Specification explains that "[t]he starting material" for liquefaction is preferably "milled whole grains, especially corn, wheat and milo." Id. at 4:16-18. The Specification explains that milled grains and water form a slurry, which can be heated for the gelatinization of the starch material, which begins between 55° and 75°C. Id. at 4:28-34. Added a-amylase is explained by the '419 patent to initiate and finalize liquefaction (thinning) of the slurry by hydrolysis. Id. at 449-58. The '419 patent states that "[m]illed and liquefied whole grains are known as mash." Id. at 4:59.

The Specification describes protease treatment initiated either after completing a liquefaction step or during a liquefaction step. Id. at 4:1-541. When protease treatment is performed post-liquefaction, the '419 patent explains "that the temperature during protease treatment in step (b) would be in the range from between 25-90°C" and "a person of ordinary skill in the art can easily determine optimal conditions for carrying out the post liquefaction step," where "[t]he protease may be of any origin." Id. at 4:62-5:14. When protease treatment and liquefaction are performed simultaneously, the '419 patent again states that "[t]he temperature during protease treatment depends on the enzymes used, but may be in the range from 25-90°C" and "[i]f the protease and alpha-amylase used are heat stable, temperature in the higher ranges may be used." Id. at 5:23-28. Regarding this simultaneous treatment, the '419 patent further states, "[i]t should be understood that degradation of protein contained in the starch-containing material may be initiated (by addition of protease) at any time during liquefaction, for instance, by addition to the aqueous slurry prior to step (a)," where step (a) is defined as "liquefying said starch-containing material with an alpha-amylase." Id. at 4:59-60, 5:37-41.

The '419 patent describes proteases that are suitable for use in its process as being "of any origin," but provides several examples. Id. at 7:29-8:53. The Specification states, "[a]ddition of protease(s) increase(s) the FAN (Free amino nitrogen) level and increases the rate of metabolism of the fermenting organism, such as yeast, and further gives higher fermentation efficiency. According to the invention a peptidase and other protein degrading enzymes are referred to as proteases." Id. at 7:32-37.

The '419 patent provides two examples, one of a "Post Liquefaction Protease Treatment of Corn Mash" where a protease was added to liquefied corn mash, and one of a "Simultaneous Liquefaction and Protein Degradation" where two proteases (Protease ALC and Peptidase A) and an a-amylase were added to a corn slurry during liquefaction. Id. at 16:35-18:41; see also id. at 13:30-45 (identifying enzymes). Each exemplary process resulted in increased ethanol yield, lowered glycerol levels, and an improved glycerol/ethanol ratio as compared to control processes that did not add protease. Id. at 17:15-24, 18:1-41, Figs. 1-6.

Regarding the steps of saccharification and fermentation that follow liquefaction, the '419 patent states that each is well-known in the art. Id. at 5:47-48, 6:30-33.

Claim 1, the '419 patent's sole independent claim, reads as follows:

1. A process for producing an alcohol from starch-containing material, comprising

(a) liquefying said starch-containing material with an alpha-amylase;

(b) treating the liquefied mash from step (a) with a protease before initiating step (c);

(c) saccharifying in the presence of a carbohydrate-source generating enzyme;

(d) fermenting in the presence of a fermenting organism to produce the alcohol.

Id. at 18:43-53. In addition to claim 1, the '419 patent includes dependent claims 2-19, which more specifically define aspects of the claimed method. For example, claim 2 further requires "[t]he process of claim 1, wherein steps (a) and (b) are carried out simultaneously or sequentially," and claim 8 further requires "[t]he process of claim 7, wherein the slurry is heated to above the initial gelatinization temperature." Id. at 18:54-55, 19:1-2. Claim 8 depends from claim 1 via dependence from intervening claim 7, which further requires "prior to the step (a) [ofclaim 1], the steps of: i) milling of starch-containing material; ii) forming a slurry comprising the milled starch-containing material and water." Id. at 18:63-67. Moreover, claims 14 and 17, respectively, further define the conditions and parameters for "the protease treatment in step (b)" of claim 1 to be "a temperature of 25-90° C" and a duration of"0.1 to 12 hours." Id. at 19:13-14, 20:4-5.

D. Petitioner 's Asserted Gro unds for Unpa tent ability

Petitioner asserts the following grounds for the unpatentability of claims 1-9, 11, 13-19 of the '419 patent:

Ground

Claims Challenged

35 U.S.C. §^[4]

Reference(s)/Basis

1-7, 11, 14, 15, 17, 18

102

WO '179^[5]

1-9, 11, 13-19

103

WO '179, Goode, ^[6]6 WO '895^[7]7

In support of these grounds for unpatentability Petitioner submits, inter alia, the ...