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Marical Inc. v. Cooke Aquaculture Inc.

United States District Court, D. Maine

July 6, 2016

MARICAL, INC., et al., Plaintiffs
v.
COOKE AQUACULTURE INC., et al., Defendants

          RECOMMENDED DECISION ON CLAIM CONSTRUCTION

          JOHN C. NIVISON U.S. MAGISTRATE JUDGE.

         In this action, Plaintiffs and Counter-claim Defendants Marical Inc., Europharma AS, and Europharma Inc. Canada (“Plaintiffs”), allege that Defendants and Counter-claim Plaintiffs Cooke Aquaculture Inc., Cooke Aquaculture USA Inc., True North Salmon Co. Ltd., True North Salmon U.S. Inc., True North Sales U.S. Inc., and Salmones Cupquelan SA (“Defendants”), produce and import salmon raised by methods that infringe United States Patent No. 6, 463, 883 (Patent ‘883), United States Patent No. 6, 475, 792 (Patent ‘792), United States Patent No. 6, 481, 379 (Patent ‘379), and United States Patent No. 6, 564, 747 (Patent ‘747), which patents-in-suit teach methods for raising pre-adult anadromous fish. (Complaint, ECF No. 1.) In their counterclaim for declaratory judgment, Defendants seek a judgment of invalidity and non-infringement. (Answer and Counterclaims, ECF No. 16.)

         The matter is before the Court on the issue of claim construction. Following a review of the record, and after consideration of the parties’ written and oral arguments, I recommend the Court construe the disputed claim terms as set forth herein.

         Background

         The parties engage in salmon aquaculture, or aquafarming. Salmon are a species of anadromous fish. In the ordinary course of nature, anadromous fish are born in freshwater, migrate and adapt to seawater in the course of their growth cycle, and return to freshwater to spawn. Salmon aquaculture operations ordinarily raise salmon in freshwater holding tanks until the salmon begin the process of smoltification, at which time salmon smolts are transferred to seawater pens where they grow to harvest weight. Because seawater contains significantly greater concentrations of salts (ionic compounds) than freshwater, anadromous fish that are transferred directly from freshwater to seawater, without preparation, can experience osmotic stress. Osmotic stress can cause a high rate of fish mortality. Osmotic stress also can cause a period of morbidity during which the fish feed at a reduced rate, which prolongs the growth process and/or reduces the net weight at harvest.

         Generally, the four patents-in-suit describe “methods, compositions and kits for improving the raising of pre-adult anadromous fish, or preparing pre-adult anadromous fish for transfer to seawater.”[1] (See Abstract of each patent.) The patents assert that proper preparation of the fish avoids or reduces osmotic stress, and thus improves the survival rate, reduces morbidity, and increases the rate at which the fish feed and gain weight following transfer to a seawater environment. The patented methods describe a process that purports to increase the expression and/or sensitivity of Polyvalent Cation Receptors (PVCR) in the fish and to increase the level of PVCR modulators in the serum of the fish, which methods prepare the fish for transfer to seawater. The methods primarily involve the introduction to the freshwater environment of one or more PVCR modulators, such as magnesium and calcium in certain molar concentrations, and the use of a fish feed containing a sufficient amount of NaCl. (See Abstract, Background, and Summary of each patent.)

         Plaintiffs allege that Defendants previously employed the patented methods at Defendants’ facilities in Maine, Chile, New Brunswick, Newfoundland, Nova Scotia, and Spain, pursuant to a license that expired in 2008. (Complaint ¶ 30.) Plaintiffs further assert that Defendants continue to employ the patented methods without a license, in violation of the four patents-in-suit. (Id., Counts I - IV.) Defendants contend they have not infringed any valid claim of the patents-in-suit, and they request a declaratory judgment of non-infringement and the invalidity of the patents. (Answer and Counterclaim at 9 - 11, 14 - 19.)

         The parties maintain that terms used in the patents require construction before the merits of the claims, defenses, and counterclaims can be resolved.[2]

         Claim Construction Principles

         The grant of a patent is the grant of a monopoly, in exchange for which monopoly the inventor is required to teach to others skilled in the art, in clear and precise language, how to practice the patented invention. 35 U.S.C. § 112; Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 368 - 69 (1938). The requirement that the patentee teach the invention in clear terms has been referred to as the “definiteness requirement.” Nautilus, Inc. v. Biosig Instr., Inc., 134 S.Ct. 2120, 2128 (2014). The definiteness requirement not only ensures that those skilled in the art will be able to practice the invention, but also provides notice of the scope of the patent. Dow Chem. Co. v. Nova Chem. Corp., 803 F.3d 620, 630 (Fed. Cir. 2015).

         To be definite, claim terms “must be precise enough to afford clear notice of what is claimed, thereby apprising the public of what is still open to them.” Nautilus, 134 S.Ct. at 2129 (internal quotation marks and bracket omitted). Without this requirement, patent applicants could employ ambiguous language to generate a “zone of uncertainty” about the scope of their invention, which uncertainty can discourage further innovation by others. Id. (quoting United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942)). In order to reconcile the “competing concerns, ” the Patent Act requires “that a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty.” Id. (recognizing that “absolute precision is unattainable”).

         The initial step in a patent infringement action involves the construction of the language used in the patent to describe the claimed invention (so-called “claim construction”).[3] Wavetronix LLC v. EIS Elec. Integrated Sys., 573 F.3d 1343, 1355 (Fed. Cir. 2009). The construction of patent claims is a matter for the court to determine as a matter of law, though the construction of a claim term can have “evidentiary underpinnings” that require “subsidiary factfinding.” Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 838 (2015). Determination of the scope of a claim involves “analysis of the whole document, ” and can require reliance on expert testimony. Nautilus, 134 S.Ct. at 2130 (quoting Markman v. Westview Instr., Inc., 517 U.S. 370, 389 (1996)).

         Person of ordinary skill in the art (POSA)

         “Claim construction seeks to ascribe the ‘ordinary and customary meaning’ to claim terms as they would be understood to a person of ordinary skill in the art at the time of invention.” Secure Web Conference Corp. v. Microsoft Corp., No. 15-1321, 2016 WL 626492, at *2 (Fed. Cir. Feb. 17, 2016). “[T]he person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). To determine “the scope and meaning” that claim terms would have to a person of ordinary skill in the art, therefore, the court considers the words of the claims themselves, the broader patent specification that incorporates the claims, the prosecution history, and if necessary, any relevant extrinsic evidence.[4] Id. at 1315 - 17; Cioffi v. Google, Inc., No. 15-1194, 2015 WL 7254039, at *4 (Fed. Cir. Nov. 17, 2015).

         Patent specification

         A patent is “a fully integrated written instrument, consisting principally of a specification that concludes with the claims, ” and “[f]or that reason, claims must be read in view of the specification.” Phillips, 415 F.3d at 1315 (internal quotation marks omitted). Always relevant and sometimes dispositive, the patent specification “is the single best guide to the meaning of a disputed term.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). “The importance of the specification in claim construction derives from …. the statutory requirement that the specification describe the claimed invention in ‘full, clear, concise, and exact terms.’” Phillips, 415 F.3d at 1316 (quoting 35 U.S.C. § 112(1)).

         In some instances “the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess.” Id. If so, “the inventor’s lexicography governs.” Id. For example, if in the specification the patentee has provided a special definition for a term that is different from the ordinary meaning of the term, the term should be construed in accordance with the special definition unless a contrary definition is apparent in a particular claim. Id. “However, a claim term is only given a special definition different from the term’s plain and ordinary meaning if the ‘patentee ... clearly set[s] forth a definition of the disputed claim term other than its plain and ordinary meaning.’” Akamai Techs., Inc. v. Limelight Networks, Inc., 805 F.3d 1368, 1375 (Fed. Cir. 2015) (quoting Thorner v. Sony Computer Entm’t Am., LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (citations omitted)).

         Patent claims

         Claims often instruct the reader on the meaning of disputed terms. Phillips, 415 F.3d at 1314. Because claim terms are generally used throughout a patent in a consistent manner, the use of a term in one claim can sometimes provide meaning in the context of another claim. Id. On the other hand, ordinarily different claims are understood to teach different embodiments of an invention (the so-called claim differentiation presumption).[5] For instance, if a claim teaches a version of the invention that is dependent on a particular limitation, process, or component, it may be inferred that the limitation, process, or component is not present in another claim lacking reference to it. Id. at 1314 - 15; Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004).

         Prosecution history

         “The prosecution history … consists of the complete record of the proceedings before the PTO [Patent Office] and includes the prior art cited during the examination of the patent.” Phillips, 415 F.3d at 1317. This historical record “provides evidence of how the PTO and the inventor understood the patent” and one may discern meaning from the record the patentee created to explain the invention to the PTO, although the record “often lacks the clarity of the specification and thus is less useful for claim construction purposes.” Id.

         Extrinsic evidence

         Extrinsic evidence “consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Id. (internal quotation marks omitted). Expert testimony “can be useful to a court for a variety of purposes, such as to provide background on the technology at issue, to explain how an invention works, to ensure that the court’s understanding … is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field.” Id. at 1318. While extrinsic evidence can be of assistance, particularly to understanding the relevant art, it generally is not as useful to claims construction as the intrinsic record. Id. at 1317. Additionally, the Court must take care when relying on expert testimony given that the testimony was not presented to the PTO and thus is not part of the prosecution history. Expert testimony should not be used to change the meaning of a patent that is meant to be a public record capable of teaching the invention without resort to extrinsic sources. Id. at 1318 - 19.

         The Person of Ordinary Skill in the Art [6]

         As a preliminary step in the claim construction process, the Court must determine the characteristics that define the person of ordinary skill in the art. According to Defendants, in this case, a person of ordinary skill in the art is a person who has (a) either a bachelor’s degree in biology with five years of hatchery experience or a master’s degree with hands-on hatchery experience, and (b) has managerial responsibility at a fish hatchery where anadromous fish are raised for transfer to seawater. (Defendants’ Opening Brief at 11, PageID # 4743.) Plaintiffs contend that the person of ordinary skill must be familiar with the “molecular techniques described in the patents” (Plaintiffs’ Responsive Brief at 5, PageID # 4818), and have “at least a master’s degree in the biological sciences, ” and “several years of experience working in aquaculture, ” such as a “Freshwater Production Manager” at a commercial hatchery that raises anadromous fish. (Jury Declaration ¶ 15, ECF No. 72, PageID # 968.) Defendants argue that a person with understanding of the molecular techniques described in the patents is not a person of ordinary skill in the art, but rather a person of extraordinary skill. (Plaintiffs’ Reply at 4 - 5, PageID # 4959 - 60.) Plaintiffs maintain that knowledge of molecular techniques is necessary because the patented methods require significant knowledge of statistics and knowledge of how to design biological studies. (Id. at 5, PageID # 4960.)

         As a general rule, the person of ordinary skill in the art is a person capable of practicing the invention as taught. 35 U.S.C. § 112(a).[7] In this case, as explained further below, to practice the invention as taught, the person of ordinary skill in the art would have on-the-job experience at a fish hatchery that raises anadromous fish for transfer to seawater, including managerial experience, would understand the growth cycle of anadromous fish and the biological and chemical factors that produce osmotic stress in anadromous fish following transfer to seawater, and would have the requisite skill to conduct one or more tests to measure PVCR expression in the tissue of fish and to conduct one or more tests to measure PVCR modulator concentrations in fish blood. To achieve the requisite level of skill, the person would have to have significant hands-on experience, and, at a minimum, a bachelor’s degree in the biological sciences.

         After review of the record, therefore, I conclude that the person of ordinary skill in the art is a person with, at a minimum, a bachelor’s degree in the biological sciences, whose educational background has been developed by managerial responsibility at a fish hatchery that raises anadromous fish for transfer to seawater, who understands the growth cycle of anadromous fish, who understand the biological and chemical factors that produce osmotic stress in anadromous fish following transfer to seawater, and who has sufficient skill to conduct one or more tests to measure PVCR expression in the tissue of fish and one or more tests to measure PVCR modulator concentrations in fish blood.[8]

         Claim Construction

         A. Preamble Language [9]

         The disputed claims begin with one of the following preambles:

“A method for preparing pre-adult anadromous fish for transfer from freshwater to seawater, comprising …”
(Patent ‘379, claim 19; Patent ‘883, claim 11.)
“A method of [or for] preparing pre-adult salmon for transfer from freshwater to seawater, comprising …”
(Patent ‘747, claim 22; ‘883, claim 23.)
“A method of improving the raising of pre-adult salmon, wherein the pre-adult salmon are maintained in freshwater prior to transfer to seawater, comprising …”
(Patent ‘379, claim 13; Patent ‘792, claim 14.)
“A method of reducing mortality of pre-adult anadromous fish upon transfer from freshwater to seawater, comprising …”
(Patent ‘747, claim 35.)
“A method of transferring a pre-adult anadromous fish from freshwater to seawater having a temperature of about 14 C. to about 19 C., comprising …”
(Patent ‘747, claim 37.)

         Preamble language, as a general rule, does not limit the scope of the invention that follows. In particular, if the claim itself “defines a structurally complete invention … and uses the preamble only to state a purpose or intended use for the invention, ” the preamble should not be treated as a limitation on the scope of the invention.[10] Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). However, “if [the preamble] recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim, ” it limits the scope of the invention. Id. (internal quotation marks omitted). For example, if deletion of the preamble would not affect the structure or steps of the claimed invention, it is not limiting. Id. at 809. “Whether to treat a preamble as a limitation is a determination ‘resolved only on review of the entire patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.’” Id. at 808 (quoting Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989) (internal brackets and ellipses omitted)).

         Defendants request a ruling that the preambles are not limiting; Plaintiffs assert that the phrases give meaning to the claims. A review of the patents reveals the preambles are in part limiting. Specifically, the preambles place the claim steps that follow in the essential context of preparing pre-adult anadromous fish or salmon for transfer to seawater. Although obvious, the fact that the methods are applied to pre-adult anadromous fish - i.e., that the fish are also present in the freshwater and are thereby adapted for transfer - is essential.

         The preamble of claim 37 of Patent ‘747, however, which preamble describes the transfer of pre-adult anadromous fish to seawater with a temperature between 14 and 19 degrees Celsius, is not limiting. In this instance, deletion of the temperature factor would not change the essential steps of the method, which simply provide for keeping fish in freshwater to which is added at least one PVCR modulator and fish feed having the specified NaCl content by weight, followed by a transfer “to seawater.” The method thus is the same method prescribed for the other patented PVCR modulator / NaCl feed methods discussed herein. In other words, successful transfer to warmer seawater is merely a benefit or intended use of the patented method, and, therefore, is not a limitation on the claim. (Patent ‘747, col. 17, ll. 10 - 14.)

         B.Freshwater” and “Maintained”

         The parties dispute the meaning of “freshwater” and whether the word “maintained” is sufficiently definite to describe a patentable process. These terms appear not only in the preambles, but also in the claims. For example:

“a) Adding magnesium and calcium to the freshwater ….”
(Patent ‘379, claim 13; Patent ‘792, claim 14.)
“b) Adding feed for fish consumption to the freshwater ….”
(Patent ‘792, claim 14.)
“The method of claim 22, wherein the pre-adult salmon are maintained in the freshwater … until the pre-adult salmon are transferred to seawater.”
(Patent ‘747, claim 23.)

         1.Freshwater [11]

         The parties propose the following construction of “freshwater”:

Plaintiffs’ construction

Defendants’ construction

Water that comes from a non-marine source, and which may include one or more additives (e.g., at least one PVCR modulator).

(ECF No. 64, PageID # 751)

Depending on the claim in question, either:

Water that comes from, for example, a stream, river, ponds, public water supply, or from other non-marine sources having, for example, the following ionic composition: less than about 2 mM of magnesium, calcium and NaCl.

(ECF No. 63, PageID # 636)

or

Water that comes from, for example, a stream, river, ponds, public water supply, or from other non-marine sources having, for example, the following ionic composition: less than about 2 mM of magnesium, calcium and NaCl and to which at least one PVCR modulator has been added.

(Id., PageID # 640.)

         The specifications of Patents ‘883 and ‘747 define “freshwater” as follows:

Water that comes from, for example, a stream, river, ponds, public water supply, or from other non-marine sources having, for example, the following ionic composition: less than about 2 mM of magnesium, calcium, and NaCl. The term “freshwater” also refers to freshwater to which at least one PVCR modulator has been added, as described herein.

(Patent ‘883, col. 6, ll. 24 - 31; Patent ‘747, col. 9, ll. 27 - 35.) Similarly, the specifications of Patents ‘379 and ‘792 define “freshwater” as:

Water that comes from, for example, a stream, river, ponds, public water supply, or from other non-marine sources having, for example, the following ionic composition: less than about 2 mM of magnesium, calcium, and NaCl. The term “freshwater” also refers to freshwater to which magnesium and calcium have been added, as described herein.

(Patent ‘379, col. 5, ll. 52 - 58; Patent ‘792, col. 6, ll. 32 - 39.)

         The term freshwater is used in the patents in many instances to identify the water in which the pre-adult fish are initially held, which water will have low salinity, e.g., salinity levels of less than about 2 mM each of magnesium, calcium, and sodium chloride, as stated in the specifications.

         The term freshwater is also used in the patents to identify water to which a patented method is applied, in which water the fish are to be maintained for a period of time before transfer to seawater.[12] In this context, freshwater describes “an aquatic mixture for providing an environment to improve the raising of pre-adult anadromous fish.” (Patent ‘883, col. 2, ll. 51 - 53.) For example, certain methods described in Patents ‘379 and ‘792 call for increasing the level of calcium to between 2.0 mM and 10.0 mM, and increasing the level of magnesium to between 0.5 mM and 10.0 mM.[13] (E.g., Patent ‘379, claims 15 and 16; Patent ‘792, claims 16 and 17.) The term freshwater is also used in some instances to describe methods involving the introduction of a “PVCR modulator” to the water, which modulator may or may not be calcium or magnesium. (E.g., Patent ‘883, claim 14; Patent ‘747, claim 23.)[14]

         After review of the record, as to Patents ‘379 and ‘792, the term “freshwater” reasonably means:

(1) water from a freshwater source, such as water sourced from a stream, river, pond, or another non-marine source, having, for example, the following ionic composition: less than about 2 mM of magnesium, calcium, and NaCl; and
(2) water described in (1) to which has been added calcium and/or magnesium to achieve concentrations in the range of between 2 mM and 10 mM calcium and between 0.5 mM and 10 mM magnesium.

         As to Patents ‘883 and ‘747, the term “freshwater” reasonably means:

(1) water from a freshwater source, such as water sourced from a stream, river, pond, or another non-marine source, having, for example, the following ionic composition: less than about 2 mM of magnesium, calcium, and NaCl; and
(2) water described in (1) to which has been added a PVCR modulator or more than one PVCR modulator.

         The definitions constitute plain and ordinary constructions that would be understood by the person of ordinary skill in the art following a review of the specifications.[15]

         2.Maintained in [the] freshwater [16]

         The parties propose the following construction of “maintained in [the] freshwater”:

Plaintiffs’ construction

Defendants’ construction

Refers to fish that are kept in freshwater for a period of time

(ECF No. 64, PageID # 776.)

Indefinite

(ECF No. 63, PageID # 663.)

         According to Defendants, “maintained in the freshwater” is indefinite because a person of ordinary skill in the art would not understand the scope of the claimed invention due to the lack of any definite minimum or maximum period during which fish must be maintained in the freshwater. (Defendants’ Opening Brief at 19, PageID # 4751.) Plaintiffs contend that a person of ordinary skill in the art would plainly understand that fish would be maintained in the freshwater for “a period of time” that would be sufficient to result in the benefits described in the patents, or for a longer period of time if desired. (Plaintiffs’ Opening Brief at 23, PageID # 941.)

         The specifications explain the reason the patents do not include in their claims the precise period of time during which fish are to be maintained in the freshwater:

The process of the present invention pre-conditions the fish and prepares them for transfer. The pre-adult anadromous fish are maintained in a freshwater environment having a PVCR modulator long enough to increase the expression and/or alter sensitivity of the PVCR. The length of time depends on the physiological and physical maturity of the fish. Some fish will more readily adapt to the environment, and increase their expression and/or alter the sensitivity of their PVCR, while others will need more time to do so. Factors that can influence the length of time necessary to increase the expression and/or alter sensitivity of the PVCR include, but are not limited to, size of the fish, level of PVCR expression or sensitivity, if any, prior to addition of the PVCR modulator to the freshwater, the fish’s ability to excrete the PVCR modulator and ions, the fish’s surface to volume ratio, etc. Therefore, the length of time the fish is maintained can range from about 7 days to several months (e.g., 7, 14, 21, 30, 45, 90 and 120 days). The fish can also be maintained indefinitely so long as the fish are maintained in freshwater having the PVCR modulator and being fed a NaCl diet. For example, salmon, trout or char weighing less than 10 gms can be maintained in freshwater having a PVCR modulator, and fed a NaCl diet for at least about 180 days, prior to transfer to seawater.

(Patent ‘379, col. 7, ll. 1 - 24; Patent ‘792, col. 7, l. 63 - col. 8, l. 20; Patent ‘883, col. 8, ll. 18 - 41; Patent ‘747, col. 11, ll. 37 - 60.)

         Based on the specifications, a person of ordinary skill in the art would understand that the methods described in the patents are to be applied during the pre-adult stage of fish development to induce or accelerate smoltification; that it would take, at a minimum, several days to prepare the fish for transfer to seawater; and that the fish are more likely to be prepared for transfer to seawater the longer the methods are applied during the pre-adult stage of development. A person of ordinary skill in the art would appreciate that a number of factors might influence an aquaculture operation’s timing of the transfer of fish to seawater, including species, starting size, and the growth cycle of the fish in question, [17] and that the process can be maintained pending transfer to seawater.[18]

         According to the specifications, “[f]ish hatcheries have experienced difficulty in raising [anadromous] fish because the window of time in which the pre-adult fish adapts to seawater (e.g., undergoes smoltification) is short-lived, and can be difficult to pinpoint.” (E.g., Patent ‘883, col. 1, ll. 11 - 14.) If salinity levels do not increase after smoltification, the fish will die. (Id., col. 11, II. 25 - 29.) As taught, a primary advantage of the patented methods is that they “eliminate[] the phenomenon known as ‘smolt window, ’” and permit the aquaculture operation to maintain fish in “freshwater” for a longer period to ensure that a greater percentage of fish are ready for transfer to seawater pens. (Id., col. 17, ll. 40 - 41.)

         The patents’ use of “maintained in the freshwater, ” is not indefinite, but rather of necessity refers to the general period of time in which pre-adult fish are prepared for transfer to seawater. The duration described in the specifications - between several days and several months, and even for a prolonged (i.e., greater than 180-day) period - describes an understandable period. While the specifications inform that the methods are designed to transition a population of fish through the smoltification process relatively promptly and with minimal loss, recognizing that some fish might respond more quickly to the methods than others, neither the specifications nor the claims describe a precise time period. The lack of a precise time period does not render the term indefinite. The specifications identify the factors that affect the length of time the fish must be maintained in the freshwater, and adequately inform the person of ordinary skill in the art that maintaining the processes for more than a few days will help prepare anadromous fish for a seawater transfer, and that maintaining the processes for weeks or months will increase the likelihood that preparedness for seawater transfer is shared throughout a fish population, without subjecting already prepared fish to the harms otherwise associated with a delayed transfer and the indeterminate smolt window. In addition, the specifications teach the use of samples and assays to determine an increase in expression of PVCR in the fish and an increase in PVCR modulator concentration in fish blood, discussed further below, which increases will inform the person of ordinary skill in the art that the fish are being prepared for transfer to seawater. (Patent ‘379, col. 10 - 15 & Examples 1, 3 - 5, 7; Patent ‘792, col. 11 - 16 & Examples 1, 3 - 5, 7; Patent ‘883, col. 12 - 14 & Examples 1, 3 - 5, 7; Patent ‘747, col. 18 - 23 & Examples 1, 3 - 7, 18 - 20.)

         In short, a person of ordinary skill in the art would understand that whether a particular fish population is prepared for transfer to seawater could be assessed by means of such samples and assays. A person of ordinary skill in the art would also appreciate that the patentees could not reasonably be expected to provide a specific minimum duration for the process that would prepare equally all anadromous fish, or all salmon, for transfer to seawater. Accordingly, a reasonable construction of “maintained in [the] freshwater” is “kept in freshwater for a period of time.”

         C. Polyvalent Cation Receptor (PVCR) Terminology

         A stated objective of the patented processes is “to increase [or modulate] expression and/or sensitivity of at least one PVCR.” (See, e.g., Patent ‘379, claim 13; Patent ‘747, claim 22; Patent ‘792, claim 14; Patent ‘883, claim 11.) This is accomplished, according to the patents, through the addition of a “PVCR modulator” or a “PVCR agonist” to the freshwater and/or the fish feed. (Patent ‘379, claims 13; Patent ‘792, claim 14; Patent ‘883, claims 11, 23; Patent ‘747, claims 22 - 24.) The patented methods teach that the fish incorporate the PVCR modulator, which increases the expression of PVCR found in certain tissue. (Patent ‘379, col. 10 - 15; Patent ‘792, col. 11 - 16; Patent ‘883, col. 12 - 14; Patent ‘747, col. 18 - 23.)

Patent ‘379:
13. A method of improving the raising of pre-adult salmon, wherein the pre-adult salmon are maintained in freshwater prior to transfer to seawater, comprising:
a) Adding magnesium and calcium to the freshwater in an amount sufficient to increase expression and/or sensitivity of at least one PVCR; and b) ….
Patent ‘792:
14. A method of improving the raising of pre-adult salmon, wherein the pre-adult salmon are maintained in freshwater prior to transfer to seawater, comprising:
a) adding magnesium and calcium to the freshwater in an amount sufficient to increase expression and/or sensitivity of at least one PVCR; and b) ….
Patent ‘883:
11. A method for preparing pre-adult anadromous fish for transfer from freshwater to seawater, comprising:
a) adding at least one PVCR modulator to the freshwater in an amount sufficient to increase expression and/or sensitivity of at least one PVCR; and b) ….
Patent ‘747:
22. A method of preparing pre-adult salmon for transfer from freshwater to seawater, comprising:
a) adding at least one PVCR modulator to the freshwater in an amount sufficient to modulate expression and/or sensitivity of at least one PVCR; and b) ….
23. The method of claim 22, wherein the pre-adult salmon are maintained in the freshwater having at least one PVCR modulator until the pre-adult ...

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