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CLINTEC NUTRITION CO. v. BAXA CORP.

August 21, 1997

CLINTEC NUTRITION COMPANY and BAXTER INTERNATIONAL, INC., Plaintiffs,
v.
BAXA CORPORATION, Defendant.



The opinion of the court was delivered by: BUCKLO

 MEMORANDUM OPINION AND ORDER

 Clintec Nutrition Company *fn1" ("Clintec") sued Baxa Corporation ("Baxa") for patent infringement, literally and under the doctrine of equivalents. Baxa moved for summary judgment. Clintec moved for summary judgment with respect to literal infringement of claim 40. Baxa moved for cross-summary judgment with respect to literal infringement of claim 40. For the following reasons, Baxa's summary judgment motion and cross-summary judgment motion are granted. Clintec's cross-summary judgment motion is denied.

 BACKGROUND

 Clintec owns U.S. Patent No. 4,653,010 ("'010 patent"). The '010 patent describes a computerized device for compounding liquids into an intravenously administered nutritional mixture. *fn2" The operator enters sets of parameters into the host computer via a video display terminal, or retrieves them from the prescription library maintained by the host computer. A "set of parameters" corresponds to an intravenous mixture, or "bag," for a given patient and is expressed in terms of different "base solutions" such as dextrose, amino acids, lipids, and sterile water. *fn3"

 The operator enters the sets of parameters into one or more time slots or queues, depending on the number of dosages to be administered to a given patient within a twenty-four hour period. Each time slot or queue corresponds to a given time interval within a twenty-four-hour day.

 The operator then reviews each queue of the sets of parameters and authorizes the compounding of each member of the queue. After all members of the queue have been reviewed for authorization, the host computer sorts the authorized sets of parameters of the given queue based on the specified types of base solution families. The sorted sequence can also be sorted a second time in accordance with the required base solution concentrations, and a third time, based on the size of the needed bag for each set of parameters.

 Once a group of authorized sets of parameters has been sorted, the system generates a set of labels corresponding to the sorted order. The sorted sets of parameters are transmitted to the compounding apparatus in the sorted order.

 The purpose of sorting the sets of parameters for mixtures to be compounded is completely to empty each base solution container during compounding, before removing it from the compounding apparatus. Waste occurs when the base solution containers are attached and detached from the compounding apparatus. Careful ordering of the mixtures to be compounded at one time minimizes the required number of base solution containers and, therefore, the associated costs. If the need arises, the operator may instruct the compounder to compound a mixture out of the sorted order.

 ANALYSIS

 It is undisputed that the claims Clintec asserts are infringed by Baxa depend upon one of the following six independent claims: 1, *fn5" 19, *fn6" 40, *fn7" 67, *fn8" 87, *fn9" and 93. *fn10" If Baxa's accused compounders do not infringe Clintec's independent claims, they likewise do not infringe Clintec's asserted claims. Carroll Touch, Inc. v. Electro Mechanical Sys., Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993). A patentee may prove infringement in one of two ways--literal infringement or infringement under the doctrine of equivalents. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., U.S. , 117 S. Ct. 1040, 1045, 137 L. Ed. 2d 146 (1997). Clintec alleges both.

 I. Literal Infringement

 A. Claims 1, 19, 87, and 93

 The first step in the literal infringement analysis is claim construction, whereby the court determines the scope and the meaning of a claim. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-79 (Fed. Cir. 1995), aff'd, 517 U.S. 370, 116 S. Ct. 1384, 134 L. Ed. 2d 577 (1996); Carroll Touch, 15 F.3d at 1576.

 At issue are the following elements *fn11" of the following claims: *fn12"

 
Claim 1--"the step[] of . . . sorting the sets of parameters in accordance with the particular base solutions included in each set and amount of each base solution included in each set to minimize the needed quantity of containers of base solution to produce said doses."
 
Claim 19--the "means for sorting said sets of parameters in accordance with the particular base solutions included in each set to minimize the required quantity of containers of base solution to produce said doses."
 
Claim 87--"the step[] of . . . sorting the sets of parameters in accordance with the particular base solutions included in each of said sets; and the amount of each particular solution included in each set to minimize the quantity of containers of base solutions necessary to produce said mixtures."
 
Claim 93--the "means for sorting said sets of parameters in accordance with the particular base solutions included in each said set and the amount of each base solution used to minimize the quantity of containers of base solutions needed to produce said doses."

 The "means" and the "step" elements of the above claims recite a function for sorting sets of parameters without reciting a definite structure in support of that function. The parties agree that Clintec has expressed these elements in the "means (or step)-plus-function" terms, subject to the requirements of 35 U.S.C. § 112, P 6, which provides that "an element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof." Literal infringement of a claim containing a means or a step clause requires that the accused device (1) perform the identical function as that identified in the limitation, and (2) do so with a structure which is the same as or equivalent to that disclosed in the specification. Carroll Touch, 15 F.3d at 1578; § 112, P 6 (means(step)-plus-function element "shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof").

 Construing the claims, I conclude that the function in the means and step elements of claims 1, 19, 87, and 93, is, unambiguously, the sorting of a set of parameters to be compounded, in accordance with the particular base solutions and their amounts to be included in each set of parameters, such as to minimize the quantity of containers of the base solutions. As to the structure, *fn13" the specification clearly discloses that it is the host computer which sorts the sets of parameters. (See '010 patent, col. 3, lines 44-50) (" The host computer then sorts all of the authorized bags based on the specified base solutions."); ('010 patent, col. 8, lines 38-49) ("After all of the members of a given queue have been reviewed for authorization the authorized members of the queue are sorted by the host computer 4 based on the specified types of base solution families . . . ."); ('010 patent, col. 4, lines 65-69) ("The cost computer stores on its disk drive 4b programs for . . . sorting. . . .") (emphases added). *fn14"

 Having been construed, the claim elements must now be compared (or applied) to the infringing devices. Carroll Touch, 15 F.3d at 1576. Although this step is for the trier of fact, summary judgment is appropriate where there is no genuine issue of material fact. Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995). To show that a genuine issue of material fact exists, Clintec relies on two groups of evidence: Baxa's own statements and Clintec's experts' reports.

 1. Baxa's Statements

 Clintec points to three statements in the operating documents of Baxa's compounders. One states that the device "sorts patient solutions when loaded from disk." (Ex. S at 13. *fn15" ) Another says that "it is also possible to create a group of solutions by repeating a series of previous solutions." (Ex. T at 5-15.) The third states that an "option switch causes TPN-PC PLUS to implement a series of modifications that emulate the behavior of the Multi-Task Operating System from Clintec." (Id. at 5-73.)

 Clintec also points to two excerpts of the testimony of Baxa's expert, Dennis Tribble. Here, Mr. Tribble stated that Baxa's compounders have the capacity to sort solution formulas based upon the patient's last name, (Tribble Dep., Ex. L at 82), and that if a user wishes, he or she may alter the sequence in which solutions are compounded. *fn16" (Id. at 276-77.)

 2. Clintec's Experts' Reports

 The Reports also state that when the operator is identifying solutions for compounding, the BAXA DirectEntry Software indicates when the solution requires an ingredient not currently installed on the compounder. The operator is prompted to load the unavailable ingredient or abort that particular compounding cycle. Thus, typically, the operator scans for and compounds only solutions which call for the current ingredient configuration. "In this way, the operator uses the DirectEntry Software to choose individual patient orders by type of source solution in order to minimize source container changes and the needed quantity of containers." (Uhen's Report, Ex. D at 33); (Campbell's Report, Ex. U at 10.)

 Finally, the Reports indicate that BAXA MicroMacro Operating Software contains a "batch mode" which allows the operator to compound chosen solutions as a group. The Software generates a batch report which lists the different source solutions to be used and their respective volumes for each batch to be compounded. Using this report, the operator configures the compounder in such a way as to compound solutions calling for the highest volumes first. Then, the operator modifies the sequence of solutions to be compounded accordingly. For example, if the report shows only a small amount of Ingredient A will be needed by a batch, the operator locates solutions that call for Ingredient A, and modifies the sequence in the batch to compound those solutions last, after another ingredient has been fully dispensed and a supply container position on the compounder is available. "This . . . enable[s] an operator to avoid hanging additional large containers if only small doses are required near the end of the batch." (Campbell's Report, Ex. U at 12.) "In this way[,] the BAXA MicroMacro Operating Software is used to sort sets of parameters by type and amount of base solution to minimize the number of supply containers needed." (Uhen's Report, Ex. D at 32.)

 The statements in Baxa's operating documents and Mr. Tribble's testimony do not create a factual issue that Baxa's compounders perform the identical function as that recited in claims 1, 19, 87, and 93, i.e., sorting a set of parameters to minimize the quantity of containers of base solutions. See Carroll Touch, 15 F.3d at 1578 (infringing device must perform identical function as that identified in means or step clause of claim). They, at best, show that Baxa's compounders can alter the sequence in which the solutions are compounded, as compared to that in which they were entered into the computer.

 Clintec's experts' Reports do show that Baxa's compounders allow the operator to arrange the sequence of the sets of parameters to be compounded so as to minimize the number of source solution containers; in other words, the operators can "sort" as that term is defined in claims 1, 19, 87, and 93. However, Clintec has offered no evidence from which a reasonable fact finder could conclude that Baxa's compounders sort by means of a computer or its equivalent. See id. (accused device must employ structure identical to or equivalent of that disclosed in specification). As a matter of law, human judgment exercised by the operator of a BAXA compounder is a structure neither identical to nor the equivalent of the computer. Davies v. United States, 31 Fed. Cl. 769, 778-79 (1994) (citing Brown v. Davis, 116 U.S. 237, 249, 6 S. Ct. 379, 385, 29 L. Ed. 659 (1886)). In Davies, the user of the accused device could manually perform the function which the patent claimed as an automatic function. Granting summary judgment to the defendant on literal infringement, the court held that where "a human being substitutes for a part of the claimed structure," the infringement standard under 35 U.S.C. § 112, P 6, that the structure be same as or equivalent to that disclosed in the specification, Carroll Touch, 15 F.3d at 1578, is not met. Davies, 31 Fed. Cl. at 778-79; see also Valley Recreation Prods., Inc. v. Arachnid, Inc., Nos. ...


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