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Kyowa Hakko Bio, Co., Ltd. v. Ajinomoto Co., Ltd.

United States District Court, D. Delaware

October 9, 2019

Kyowa Hakko Bio, Co., Ltd, et al Plaintiffs,
v.
Ajinomoto Co., Ltd. et al Defendants.

          CLAIM CONSTRUCTION OPINION

          RICHARD A. LLORET U.S. MAGISTRATE JUDGE

         INTRODUCTION

         Kyowa Hakko Bio, Co., Ltd. and related companies (“Plaintiffs, ” or “Kyowa”) filed a complaint claiming that Ajinomoto Co. Ltd. and related companies (“Defendants, ” or “Ajinomoto”) infringe their U.S. Patent No. 45, 723 (“the ‘723 patent” or “'723”) by making amino acids[1] by a method[2] claimed in the ‘723 patent. Docket Item (“D.I.”) 1, ¶ 1-2. The case has been referred to me for claim construction under Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). D.I. 76. The parties have briefed the issues thoroughly, and I held oral argument on July 29, 2019. This opinion construes the disputed claim language.

         STANDARD OF REVIEW

         “[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.” Eli Lilly and Company v. Eagle Pharmaceuticals, Inc., 2019 WL 1299212, at *1 (D.Del. 2019) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). Claim construction is a question of law. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015). Claim terms generally are given “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (quoted in Eli Lilly, 2019 WL 1299212, at *1). This general rule gives way when the patentee sets out a defined term in the patent, or disavows the full scope of the term's ordinary meaning, either in the specification or during prosecution. Unwired Planet, LLC v. Apple Inc., 829 F.3d 1353, 1358 (Fed. Cir. 2016).

         Courts look for a term's ordinary meaning in the “intrinsic evidence, ” which is the claim language, the specification, and the prosecution history. Leseman, LLC v. Stratasys, Inc., 730 Fed.Appx. 912, 914 (Fed. Cir. 2018). If necessary, a court may also look to “extrinsic evidence, ” which includes “expert and inventor testimony, dictionaries, and learned treatises.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995). Extrinsic evidence may not be used “for the purpose of varying or contradicting the terms of the claims.” Markman, 52 F.3d at 981. “The construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction.” Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).

         BACKGROUND

         Amino acids are mass produced by fermentation. Declaration of Dr. Michael F. Doherty (“Doherty”), D.I. 84, at ¶¶16-18; Declaration of Dr. Allen S. Myerson (“Myerson”), D.I. 85, at ¶¶1-15. Fermentation is a process that uses microorganisms (often bacteria) to produce a chemical. Id. The bacteria are placed in a fermentation broth, also called a culture, in which the bacteria grow, releasing amino acids into the broth as a by-product. Id. The amino acids eventually crystalize and can then be separated from the bacteria in the broth. '723 patent at 1:18-41.

         The broth becomes more and more concentrated as the bacteria produces amino acids, until the broth reaches a point called saturation, which means that under the existing conditions the broth cannot hold any more dissolved amino acid. Doherty at ¶¶18 -19; Myerson at ¶15. If more amino acid is added to a saturated solution it becomes “supersaturated.” Id. In a supersaturated solution, the amino acids precipitate (“nucleate out”) and begin to form crystals. Doherty at ¶¶18 -19; Myerson at ¶¶15-16.

         “Seeding” crystal particles into the broth can change the growth pattern of amino acid crystals. The amino acids latch onto the seed crystals and grow larger crystal particles than they would if nucleated out on their own. Myerson at ¶16. These larger crystals can then be more easily harvested from the broth. Doherty at ¶¶20-21. Seed crystals of the desired size can be introduced into the broth directly, or by different types of agitation, shock, friction, and pressure. Doherty at ¶23-25.

         THE PATENT

         Claim 1 of the ‘723 patent (referred to as “Claim 1”) describes a process for efficiently growing amino acid crystals in an amino acid broth by adding (“seeding”) amino acid crystals of a particular average size to the broth at a particular time in the brewing process. D.I. 1, ¶56. Claim 1 measures the results of the process by the concentration of the crystals produced. Id. Claim 2 of the ‘723 patent adopts the process in Claim 1, but measures the results differently. Id., ¶57. Claims 7 and 8 are dependent on Claims 1 and 2, respectively. Id., at ¶59. Both Claims 1 and 2 require that added crystals be within a specific size range, defined by their “average particle size, ” and be added at a particular time. Pl. Br. at 1.

         Claim 1 of the patent reads as follows:[3]

1. A process for producing an amino acid, which comprises:
[a] culturing a microorganism having an ability to produce the amino acid in a medium,
[b] adding crystals of the amino acid having an average particle size of 7 to 50 μm to the medium at some time after the amino acid concentration in the medium reaches the saturation solubility and before crystals of the amino acid deposit in the medium so that the concentration of the crystals of the amino acid becomes 0.5 g/l or more,
[c] culturing the microorganism having the ability to produce the amino acid in the medium,
[d] allowing the crystals of the amino acid to grow to crystals of the amino acid having an average particle size of 30 μm or more and accumulate in the medium, and
[e] recovering the crystals of the amino acid from the culture by separating the microorganism producing the amino acid and the accumulated crystals of the amino acid based on the difference in particle size or specific gravity between them.

D.I. 1, ¶ 56. Claim 2 tracks the language of Claim 1, but where Claim 1 requires the concentration of the crystals to reach a certain number of grams per liter (sub-paragraph (b)), Claim 2 requires the crystals in the medium to reach a certain total surface area. ‘723 patent at 11:8-10.

         The '723 patent purported to solve some problems with then existing methods of collecting amino acids from a broth. One problem was that high concentration of amino acids in the broth tended to inhibit further production of crystals. ‘723 patent at 1:31-32.[4] Prior methods also yielded a lot of microcrystals that were difficult to separate from the broth because of their extremely small size. ‘723 patent at 1:42-51. Because the microcrystals were too small to be efficiently directly removed from the medium, the prior art required additional steps to harvest crystals, such as adding water and heat, or using a centrifugal or filtration separator. Id. at 1:46-51.

         The '723 patent overcame the problems by its crystal seeding method. The inventors claimed that once the fermentation broth is saturated, adding seed crystals of a size range from 7-50 microns, at a great enough concentration (0.5 grams per liter or more), at a point in time after saturation but before crystals deposit, provided a dispersed crystal surface onto which amino acids will latch when forming crystals. See Id. at 10:45-67. This method generates enough crystals of the correct size so that the suspended amino acid has somewhere to go once it nucleates, stimulating continued production. See Id. at 10:12-24. It also generates crystals large enough to be easily separated from the microbes in the broth. See Id. at 9:17-30.

         THE DISPUTE

         The parties dispute the construction of three phrases in Claims 1 and 2: “average particle size, ” in subparagraph [a], above, “adding crystals of the amino acid . . . to the medium” at the beginning of subparagraph [b], and “before crystals of the amino acid deposit in the medium, ” at the end of subparagraph [b]. D.I. 68-1 (“Joint Claim Construction Chart” or “JCCC”).

         A. Average particle size.

         Kyowa contends that the phrase “average particle size” means “[t]he sum of particle sizes divided by the number of particles.” Id. at 2. Ajinomoto argues that the phrase means “volume average diameter (or volume mean diameter), ” or that alternatively, the term is indefinite. Id. at 2-3.

         An ordinary use of the term “average” refers to a numeric average. If I mention that the average age of federal judges is 39 (a dubious assertion), it means to the ordinary user of English that I have added up the ages of all federal judges and divided that sum by the number of judges. “Average particle size” has an ordinary English meaning, in this sense: the size of each of the particles in a given set, added together, and divided by the number of particles. The question is whether this is the ordinary or customary meaning of the phrase to the person of ordinary skill in the art. Phillips, 415 F.3d at 1313. There are reasons to believe that “average particle size, ” as used in the patent, could have meant either what it would suggest to an ordinary speaker of English or a volume weighted average diameter. To understand these reasons, and to weigh them appropriately, it is necessary to explain some details about measuring particles and calculating average sizes. After doing so I will examine the parties' arguments.

         1. Measuring particles.

         There are various ways to measure particles: sieving, in which particles are shaken over a sieve with specifically sized holes; image analysis, in which an image of the particle is measured against a reference scale; focused beam reflectance measurement (“FBRM”), which measures the light bouncing back from a laser directed into a group of particles; laser diffraction, which measures the amount of light scattered when a laser hits a particle; sedimentation, which equates how long a particle takes to fall through a known liquid to a sphere that would fall at the same rate through the same liquid; and electrozone sensing, which equates a particle's size to its electrical conductivity. Pl. Br. at 5-6; Doherty at ¶27; Myerson at ¶33.

         Particles come in all kinds of shapes. The parties agree that a standard convention used by persons of skill in the art is to assume that the measured particle is a sphere. See ‘723 patent at 8:37-40; Doherty at ¶26; Myerson at ¶30, 32. This convention trades precision for the convenience of allowing practitioners to characterize particles by one number - a diameter. Doherty at ¶26; Myerson at ¶32-34.

         2. Averaging the size of particles.

         (Image Omitted)

         The various sizes of a group of particles may be reported as a curve, as in the image above. Pl. Br. at 7. Practitioners also have developed two categories of mathematical formulae for reporting on the size of a group of particles as a single number: “number average” and “weighted average.” Doherty at ¶ 38; see Myerson at ¶35. These two categories of averaging methodology have different iterations and different statistical purposes. Doherty at ¶¶54-71; Myerson at ¶¶33-36. The number average category includes a “simple average” - also called an “arithmetic mean particle diameter” - equation: adding up the ...


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