Zumbro, Inc. v. Merck & Co. (819 F. Supp. 1387, 1993)

United States District Court for the Northern District of Illinois 1993-03-04

Citations

Full opinion text

ORDER

NORGLE, District Judge.

Before the court is Magistrate Judge Rebecca R. Pallmeyer's 83-page Report and Recommendation (the “Report”), dated November 13, 1992, which recommends: (1) granting Merck’s motion for summary judgment asserting that all claims of Zumbro’s patent are invalid on account of the inventors’ failure to comply with the best mode requirement of 35 U.S.C. § 112; (2) or alternatively, granting Merck’s motion for summary judgment asserting that all claims of Zumbro’s patent are invalid on account of the inventors’ pre-critical date commercial activity (the Unifiber sale) under 35 U.S.C. § 102(b); and (3) denying Zumbro’s motion for summary judgment asserting that its patent is presumptively valid and has been infringed.

The court has made a de novo review of the Report, 28 U.S.C. § 636(b)(1), and finds it to be thorough, accurate, and the decision proper. Furthermore, neither party has filed any objections to the Report, and consequently, such failure to object constitutes a waiver of the right to appeal this decision. Egert v. Connecticut General Life Ins. Co., 900 F.2d 1032, 1039 (7th Cir.1990). Accordingly, the Court adopts and incorporates Magistrate Judge Pallmeyer’s Report pursuant to 28 U.S.C. § 636(b)(1) with the following modification.

The Report correctly states that if the court adopts the Magistrate Judge’s first recommendation, granting summary judgment in favor of Merck on the “best mode” grounds, it need not consider issues relating to the other motions because granting summary judgment is dispositive of this case. However, because the Report is thorough, accurate, and supported by the record, the court adopts the Report’s recommendations as to each issue decided by Magistrate Judge Pallmeyer. Therefore, Merck’s two summary judgment motions as to the validity of the patent claim in question are granted, and Zumbro’s summary judgment motion is denied.

The court is aware that Merck had filed an additional motion for summary judgment of non-infringement. Although the Report states that “Merck has presented substantial support for a summary judgment in its favor on this issue,” it nevertheless fails to make a “firm recommendation regarding this motion.” Because the Report lacks a recommendation as to this issue, and because the court adopts the recommendation that summary judgment be granted in favor of Merck on other bases, Merck’s motion for summary judgment on non-infringement is denied as moot.

TABLE OF CONTENTS

Standard for Summary Judgment in a Patent Case...............................1395

Factual Background............................................................1395

The Patented Process........................................................1395

The Parties .................................................................1396

Merck’s Motion for Summary Judgment on Grounds of “Best Mode” Violation......1397

A. Facts Relating to Best Mode.............................................1397

B. Analysis of “Best Mode” Motion..........................................1399

1. Standards for Proving Violations of Best Mode........................1399

2. Analysis of the ’938 Patent.. .•...............■.........................1400

a. Failure to Disclose Operating Parameters of the Glatt WSG 120 ... 1402

b. Whether Zumbro Has Shown a Genuine Dispute of Material Fact... 1405

Recommendation.............................................................1407

Merck’s Motion for Summary Judgment on Grounds of Violation of “On Sale” Bar of 35 U.S.C. § 102(b)...........................................................1407

A. Facts Relating to “On Sale” Motion ......................................1407

1. Run No. H132001 ...................................................1408

2. The Unifiber Product................................................1409

B. Analysis of “On Sale” Motion ................i...........................1409

1. Standards for Proof of “On Sale” Activity.............................1409

2. Analysis of Defendant’s Claim that Sander and Cook Violated the “On Sale” Bar of 35 U.S.C. § 102(b)....................................1410

a. Did IFP Offer Its Custom Processing for Sale by Providing Kelco with a Sample of the Product of Run No. H132001?.............1411

b. Was Run No. H220801 (Unifiber) Produced by the Method of Claims 1 and 15 of the ’938 Patent?...................................1413

(i) ¶ 27 of Merck’s Local Rule 12(m) On Sale Statement..........1415

(ii) ¶ 28 of Merck’s Rule 12(m) On Sale Statement................1416

Recommendation.............................................................1416

Motions For Summary Judgment of Validity, Infringement and Non-Infringement... 1416

A. Facts Relating to Validity and Infringement...............................1417

B. Analysis of Zumbro’s Motion for Summary Judgment of Validity............1417

1. Pertinent Prior Art Patents Not Considered by the Patent Examiner ... 1418

2. Invalidity of Claims 26 and 27 Based on Uneited Pertinent Prior Art ... 1419

3. IFP’s Agglomeration for T.J. Lipton Prior to the Critical Date.........1419

Recommendation.............................................................1420

C. Analysis of Zumbro’s Motion for Summary Judgment of Infringement.......1420

1.Standards for Summary Judgment of Infringement.....................1420

a. Literal Infringement.............................................1420

b. Claim Interpretation.............................................1420

(i) The Meaning of “Intermittent Spraying” ......................1421

(ii) Internal Operation of the WSG Process and the GPCG Process... 1422

(iii) Absence of Particulate Carrier in Keltrol RD..................1422

D. Analysis of Merck’s Motion for Summary Judgment of Non-Infringement ... 1423

1. Whether Zumbro’s Claims Require Both a “Vegetable Gum” and a Separate “Food Grade Particulate Carrier”..........................1423

2. The Specification’s Differentiation of “Particulate Carrier” and “Vegetable Gum”.........................................................1424

a. Definition of “Food Grade Particulate Carrier”.....................1424

b. Function of the Food Grade Particulate Carrier...................1425

c. May Limitations Be Read into the Claims?........................1425

3. The Inventors’ Admissions Concerning the Specification’s Silence about “Vegetable Gum” Constituting a “Particulate Carrier”................1426

4. The Prosecution History of Claims 26 and 27 .........................1427

5. Cancelled Claim 17..................................................1428

Recommendation.............................................................1429

CONCLUSION................................................................1429

REPORT AND RECOMMENDATION

PALLMEYER, United States Magistrate Judge.

Plaintiff Zumbro, Inc. (“Zumbro”) filed its complaint on May 1, 1990, pursuant to 28 U.S.C. §§ 1338(a) and 1400(b) to recover compensation for use of its patented invention by Defendant Merck and Co., Inc. (“Merck”). Zumbro is the owner of U.S. Patent No. 4,557,938 (the ’938 patent), entitled “Product and Process for Improving the Dispersion of a Vegetable Gum in Water,” and issued December 10,1985 by assignment from the co-inventors of the patent, Eugene H. Sander and Douglas R. Cook. On June 5, 1990, Defendant filed its answer, affirmative defenses, and counterclaim. Plaintiff filed its reply to the counterclaim on June 26, 1990. Plaintiff amended its complaint on September 14, 1990.

Merck has filed three motions for summary judgment. Two of the motions assert that Zumbro’s patent was rendered invalid by acts or omissions of the inventors prior to applying for the patent. One of these motions argues that the inventors’ failure to disclose the “best mode” of carrying out the invention, as required by 35 U.S.C. § 112, renders the patent invalid and unenforceable. In a second motion, Merck seeks summary judgment of invalidity of the ’938 patent on the ground that the method of that patent was allegedly commercially exploited prior to the statutory one-year grace period set forth in 35 U.S.C. § 102(b). The third motion asserts that, even if the patent is valid, Merck has not infringed any of the allowed claims of the patent. Plaintiff Zumbro has filed its own motion for summary judgment, asserting that its patent is presumptively valid and has been infringed.

This case was originally assigned to Judge Brian B. Duff. It was reassigned to Judge Charles R. Norgle on May 8, 1991. Judge Norgle referred the case to Magistrate Judge Elaine Bucklo on June 14, 1991 for all pre-trial matters. The referral was transferred to these chambers pursuant to order of the Executive Committee dated October 10, 1991.

The parties’ four motions have generated a voluminous record and raise complicated issues. Although a ruling on any of the four motions would be dispositive, this Report nevertheless addresses each motion in some detail.

Standard for Summary Judgment in a Patent Case

Summary judgment in a patent case, as in any other type of case, is appropriate when there are no genuine issues of fact and the movant is entitled to judgment as a matter of law. Jamesbury Corp. v. Litton Indus. Products, Inc., 839 F.2d 1544, 1548 (Fed. Cir.), cert. denied, 488 U.S. 828, 109 S.Ct. 80, 102 L.Ed.2d 57 (1988); Flow-Rite of Tennessee, Inc. v. Sears Roebuck & Co., Inc., 20 U.S.P.Q.2d 1361, 1991 WL 144158 (N.D.Ill. 1991). The moving party bears the burden of demonstrating the absence of all genuine issues of material fact. SRI Int’l v. Matsushita Elec. Corp. of America, 775 F.2d 1107, 1116 (Fed.Cir.1985). In deciding whether a genuine issue of material fact exists for purposes of summary judgment, a court should look beyond bare arguments and resolve any doubts over issues of fact in favor of the party opposing summary judgment. Palumbo v. Don-Joy Co., 762 F.2d 969, 973 (Fed. Cir.1985). When the movant has supported his motion as provided by Fed.R.Civ.P. 56(c), however, the opposing party must come forward with evidence directed to specific facts showing that there is a genuine issue for trial. Fed.R.Civ.P. 56(e). Mere denials or eonclusory statements are not sufficient. Jamesbury Corp., 839 F.2d at 1548.

FACTUAL BACKGROUND

The parties have submitted separate Local Rule 12(m) and 12(n) Statements for each of the four motions for summary judgment. The following discussion begins with a description of background facts relevant to all of the motions. Facts relevant to each motion are then presented separately.

The Patented Process

The invention that is the subject of this litigation involves a process for increasing the rate and quality of dispersion of a vegetable gum in water. One type of vegetable gum used in this process is xanthan gum. The process has applications in the instant powdered food industry, where it can be used to enhance the solubility of powdered foods, such as instant soups or gravies, in water. The addition of a vegetable gum powder to water frequently results in the lumping of gum particles into a gel-like substance, wet on the outside, dry in the center. The lumps result from competition between gum particles for available water, for which many gums have strong affinity. Such lumps, referred to as “fisheyes,” are extremely resistant to dispersion even upon vigorous agitation or cooking. (Zumbro’s 12(n) Best Mode Statement, ¶ 50.) One of Merck’s own patents, in fact, states that “[a] difficulty with many of these compounds [e.g. polysaccharides] is that the more soluble they are in water, the more non-dispersible they are----” (I. Cottrell, et al. “Dispersible Xanthan Gum Blends,” U.S. Patent No. 4,363,669, Dec. 14, 1982, Ex. J. to Zumbro’s 12(n) Best Mode Statement, col. 1, ins. 19-21.) Another Merck patent states that “Mypically, xanthan gum powder must be subjected to high agitation, as in a typical kitchen blender, to get it to disperse and hydrate.” (J. Baird, et al. “Dispersible Xanthan Gum,” U.S. Patent No. 4,654,086, Mar. 31,1987, Ex. K to Zumbro’s 12(n) Best Mode Statement, col. 1., Ins. 13-15.)

Once dispersal of a gum is achieved, however, hydration of the gum, as evidenced by the development of viscosity, is usually quite rapid. (F. Maske et al., “Dispersible Glyoxal-Xanthan Gum Complexes,” U.S. Patent No. 4,041,234, Aug. 9, 1977 (“234 Patent”), Ex. S to Zumbro’s 12(m) Infringement Statement, col. 1, Ins. 25-27.)

The invention of the ’938 patent relates to one of many methods for agglomeration. Claims 1 and 15 of the ’938 patent are independent, (i.e., claims which do not refer to any other claims for support and which stand alone; and both claim a method). In the ’938 patent, Claims 1-12 and 15-27 are directed to a multi-stepped process that begins with two types of particles: a “food grade particulate carrier” and “vegetable gum particles.” The product that is produced by the method of the ’938 patent is an “agglomerated particle.”

According to the terms of the patent, the process involves dry blending a vegetable gum in a fluid bed dryer with a food grade particulate carrier, such as starch, to form a dry blended mixture. The dry carrier-vegetable gum mixture is then “fluidized” with a gaseous air stream and sprayed intermittently with a fluid so that the vegetable gum and the carrier particles are wetted. Intermittent spraying and drying of the fluidized mixture allows the carrier and vegetable gum particles to dry while in contact with each other, thereby “agglomerating” vegetable gum and carrier particles with each other. The resultant agglomeration of vegetable gum and starch or equivalent particles increases the rate at which the gum will disperse within an aqueous solution and virtually eliminates the formation of “fisheyes” in the solution. Ultimately, the process results in the agglomeration of vegetable gum/carrier particles that have a moisture content below approximately 25 percent by weight.

The Parties

Plaintiff Zumbro is a Minnesota corporation, having its principal place of business at Hayfield, Minnesota. Zumbro is the assignee of Eugene H. Sander, an inventor and prior assignee of Douglas R. Cook, also an inventor. Both Sander and Cook are listed on the face of the ’938 patent as its co-inventors. At the time Sander and Cook reduced their process of invention to practice in November 1981, Sander was a one-third shareholder of Innovative Food Processors (“IFP”) (not a party to this litigation). Defendant Merck has its regular place of business at Chicago, Illinois. The Kelco division of Defendant Merck, at various times, was a supplier of unagglomerated xanthan gum to IFP and Zumbro. (Zumbro’s 12(n) On Sale Statement, ¶ 57.)

MERCK’S MOTION FOR SUMMARY JUDGMENT ON GROUNDS OF “BEST MODE” VIOLATION

A. Facts Relating to Best Mode

The inventors’ purpose for developing the process whose patent is challenged here was to overcome the poor dispersion characteristics of vegetable gums in water. (Merck’s 12(m) Best Mode Statement, ¶ 54, Zumbro’s 12(n), ¶ 54.) Eugene Sander, one of the co-inventors, holds a Ph.D in food science, has taught at the University of Minnesota, and performed technical services for General Mills and for Grain Processing Corporation. At General Mills, Sander worked on improving the dispersibility of gums such as algin gum. Sander joined Grain Processing Corporation in 1978, and served as its Vice President of Technical Resources until March, 1983, when he left Grain Processing to devote full time to his own business, IFP, in Hayfield, Minnesota. Sander became involved in agglomerating maltodextrin for Grain Processing on Aeromatie, Glatt, and Freund fluidized bed dryers in 1980. During the summer of 1982, according to his deposition testimony, Sander was “still learning a lot about how to mechanically operate the system.” He had encountered problems requiring adjustments to nozzles and air pressures within the fluid bed equipment. Sander recognized that agglomerating gum and particulate carrier in the Glatt WSG 120 [a fluid bed dryer] was not a simple process: “[Y]ou can’t predict with every product [that is put into the Glatt WSG 120] that you will have success.” (Ex. 4 to Merck’s 12(m) Best Mode Statement, at 247.)

Douglas Cook, the other co-inventor, obtained his M.S. degree in food science and nutrition from the University of Minnesota in March 1981. He started working with IFP in June 1981. Cook learned how to operate the Glatt WSG 120 from Sander and from his own trial and error.

The agglomeration process described in the ’938 patent was first performed in a commercially available device manufactured by Glatt Air Technologies, Inc. (“Glatt”), known as the Glatt WSG 120 fluid bed processing system. Sander, doing business as a corporation named DSCS [Droogsma, Sander, Chappell, Salonek] Corporation, had purchased the Glatt WSG 120 in May 1981 and leased it to IFP. The Glatt Instruction Manual contains schematics, explanations of functions, descriptions of controls, and a general explanation of the process of granulation or agglomeration as performed on the Glatt WSG. The Manual was not, however, a complete source for the “rules of thumb” or the standard operating conditions for performing agglomeration processes with the Glatt WSG 120. Indeed, the Manual directs the operator to determine the best operating conditions to obtain the optimum agglomeration: “In order to obtain best results, one must find out the most suitable way.” (Ex. 7 to Merck’s 12(m) Best Mode Statement, at 05-004.)

Adjustments of the spray nozzle, nozzle height, atomization air pressure, and other conditions in the Glatt WSG 120 affect the size and pattern of the spray zone in the fluidized bed. Fluidizing air pressure may range from one (1) bar pressure (atmospheric pressure of 14.7 lbs./square inch “psi” — the pressure of an inflatable pool toy) up to six (6) bar pressure (6 times atmospheric pressure, or 88.2 psi — the pressure in a racing bicycle tire). The spray nozzle sprays in a cone or zone, and particles passing through that zone will come into contact with the liquid. The angle setting on the spray nozzle changes the angle on the spray pattern, and is adjustable from its full closed position up to four 360 degree turns (1440 total degrees). The nozzle height is adjustable above the bed height from about eighteen inches down to zero inches. Control of agglomeration is achieved through adjustments of these parameters — for example, adjustments of the nozzle height or the atomizing air pressure. (Merck’s 12(m) Best Mode Statement, ¶¶ 12.1-12.4.)

At his deposition, Inventor Cook testified that certain operating conditions were “critical” to the operation of the agglomeration process. He admitted that the patent did not specify the majority of such conditions or parameters. Among his list of twelve critical parameters, Cook identified various operating constants (i.e., pump type, nozzle height, port size, angle setting, atomization air pressure, spray interval, and shake interval) and operation conditions (i.e., inlet temperature settings, pump speeds (rpm), damper settings, total process time, and the composition of the binder). Cook admitted that the patent disclosed only four of the critical parameters: inlet temperature, total process time, spray interval, and shake interval; the other eight were not listed. (Ex. 5 to Merck’s 12(m) Best Mode Statement, at 130-32, 144-53.) One of the disclosed parameters in fact was incorrect; the spray interval utilized in the patented process was actually twenty-five seconds rather than thirty-five seconds, as reported in the patent. Cook acknowledged the inaccuracy of this step of the agglomeration process, due either to a drafting or typographical error; if this step were followed, the process would not function as described in the patent.

IFP customarily filled out a record called a “process data” sheet for each agglomeration process performed on the Glatt WSG 120 by recording the amount and composition of materials to be agglomerated; the composition of the binder solution; and the various operating constants, operation conditions, and comments regarding the success of the run. The entries on the process data sheet for Run H132001, which represents the first agglomeration of gum and particulate carrier performed on the Glatt WSG 120 in November 1981, note the optimal settings and adjustments to the Glatt machine known to Sander at that time. After November 1981, Sander operated the Glatt WSG 120 at or near full capacity (200 lbs). At least ten agglomerations of 20% xanthan gum/80% carrier (Insta*Thiek X-10) were performed at IFP in 1983, prior to the filing of the application of the ’938 patent.

Before August 1983, Sander and Cook coauthored “A Method for Improving the Rate of Polysaccharide Dispersibility/Dissolution Rates.” In that report, the inventors wrote:

Three production runs (200 pound batches each), H3014041-03 (xanthan/maltodextrin M-100) are presented as evidence of reduction to commercial practice. Run data sheets show typical operating process parameters used; ____ Two goals in these runs were 1) to establish optimum process conditions which would produce an acceptable product within a 30-minute run time, and 2) to establish product reproducibility from batch to batch.

(Ex. 16 to Merck’s 12(m) Best Mode Statement, at 6.)

On August 17, 1983, Sander and Cook filed their patent application containing the following claim:

A process for preparing an agglomerated particle having a vegetable gum component, the particle characterized by its quick dispersibility and dissolution into an aqueous solution, the process comprising: Agglomerating vegetable gum particles with a food grade particulate carrier to produce an agglomerated particle wherein the carrier and gum particles are bound to each other and the finished agglomerated particles having a moisture content below approximately 25% by weight of'the agglomerated particle.

(Ex. 12 to Merck’s 12(m) Best Mode Statement, at 1-2.)

On October 25, 1984, the U.S. Patent and Trademark Office rejected the original application for the Sander/Cook patent on the ground that all the claims were unpatentable in view of the prior art. The examiner wrote:

Purves et al and Gidlow disclose that fluidized bed agglomeration of sticky substances is old. To agglomerate gums such as the hydro colloids claimed as well as starches and proteins is also old as shown by Blondheim et al, Sienkiewicz et al, Reimers et al and Guckenberg [sic] et al.

(Ex. 10 to Merck’s 12(m) Best Mode Statement, at 2.)

On March 11, 1985, Sander and Cook filed an amendment to the rejected claims, stating that “[a]s disclosed in the present application and as defined by the claims, gum particles of the present invention are agglomerated by intermittently drying and wetting in a fluidized bed condition created by a gaseous stream.” (Ex. 12 to Merck’s 12(m) Best Mode Statement, at 8.)

Thereafter, on December 10, 1985, the U.S. Patent and Trademark Office issued Patent No. 4,557,938 for Sander’s and Cook’s process. The ’938 patent states that “the resultant agglomeration of vegetable gum and starch or equivalent particles surprisingly [sic] increases the rate of dispersion of the gum within an aqueous solution ...” (’938 patent, col. 2, Ins. 24-28.) In the agglomerate produced by the process of the ’938 patent, interstitial voids are left allowing entry by water for hydration with the gum. (Zumbro’s 12(n) Best Mode Statement, ¶ 58.) The patent also describes the characteristics of the preferred agglomerated particles: the particles exhibited a size distribution such that 98 percent passed through a ten mesh sieve and not more than ten percent passed through a 200 mesh sieve. (’938 patent, col. 3, Ins. 62-65.) The patent does state that, depending upon the end application, another particle size distribution could be used. Water constitutes less then ten percent by weight of the agglomerated particles after processing. (Id. col. 3, Ins. 56-57.) The patent further sets forth viscosity development characteristics, testing procedures, and control comparisons. (Id. Examples 1-27.) Finally, the patent indicates that the suitable apparatus for achieving the process of the invention are fluid bed dryers, such as the Glatt WSG 120. (Id. col. 3, Ins. 28-35.) According to Kenneth Olson, senior vice president of Glatt, the agglomeration process was merely a product application of something done “all the time.” (Ex. O to Zumbro’s 12(n) Best Mode Statement, ¶ 64.)

B. Analysis of “Best Mode” Motion

1. Standards for Proving Violations of Best Mode

Defendant moves for summary judgment as to the invalidity of the ’938 patent for its failure to disclose the “best mode” process of carrying out the claimed invention known to the inventors at the time they filed their application for the patent. Under 35 U.S.C. § 112, a patent application must “set forth the best mode contemplated by the inventor of carrying out his invention.” A patent applicant is expected to disclose information sufficient to enable another person skilled in the art to practice the best mode. Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1209 (Fed. Cir.), cert. denied, — U.S. —, 112 S.Ct. 169, 116 L.Ed.2d 132 (1991). The determination of whether or not a patent application adequately specifies the contemplated best mode is a question of fact. Dana Corp. v. IPC Ltd. Partnership, 860 F.2d 415, 418 (Fed.Cir.1988), cert. denied, 490 U.S. 1067, 109 S.Ct. 2068, 104 L.Ed.2d 633 (1989); Consolidated Aluminum Corp. v. Foseco Int'l Ltd., 716 F.Supp. 316, 321 (N.D.Ill.1989), aff'd, 910 F.2d 804 (Fed.Cir.1990).

The purpose underlying the best mode requirement is to restrain inventors from applying for a patent while at the same time concealing from the public preferred embodiments of their inventions which they have in fact conceived. Wahl Instruments, Inc. v. Acvious, Inc., 950 F.2d 1575, 1579 (Fed.Cir.1991). The best mode requirement is thus aimed at ensuring that a patent applicant plays “fair and square” with the patent system. Amgen, Inc., 927 F.2d at 1209-10. If the best mode contemplated by the inventor is not submitted in the patent application, the patent is invalid. Dana Corp., 860 F.2d at 420.

The best mode inquiry involves two components. To prove failure to disclose the best mode, defendant must first show that the inventor contemplated a better mode than any other for practicing the invention at the time of filing of the patent application. This part of the analysis is subjective and examines whether the inventor must disclose any facts in addition to those sufficient for enablement (i.e., to enable one skilled in the art to make and utilize the invention). Only evidence of “concealment,” whether accidental or intentional, is considered. Second, defendant must demonstrate that the inventor concealed that preferred mode from the public. This second part of the inquiry compares what the inventor knew with what he disclosed — in other words, is the disclosure adequate to enable one skilled in the art to practice the best mode? Shearing v. Iolab Corp., 975 F.2d 1541, 1992 WL 220185, at *4 (Fed.Cir. Sept. 11, 1992); Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 926-28 (Fed.Cir.1990). Where a person skilled in the art “simply could not divine” the most advantageous way to use an invention, the best mode requirement is not met. Id. at 929. Defendant must prove that the patent applicant failed to comply with the “best mode” requirement by clear and convincing evidence. Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1531 (Fed.Cir.1991).

Patent law does not require the patentee to disclose specific data on how to mass-produce the invented product, nor to list the dimensions, tolerances, drawings, and other parameters of mass production not necessary to enable one skilled in the art to practice the invention. Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544 (Fed. Cir.1987), vacated on other grounds, 486 U.S. 800, 108 S.Ct, 2166, 100 L.Ed.2d 811 (1988). Noncompliance with the best mode requirement will be found only if the patent applicant has concealed, either knowingly or accidentally, “his or her preferred embodiment of the claimed invention.” Christianson v. Colt Industries Operating Corp., 870 F.2d 1292, 1301 (7th Cir.), cert. denied, 493 U.S. 822, 110 S.Ct. 81, 107 L.Ed.2d 47 (1989). The patent applicant must disclose “the best mode of carrying out his claimed invention, not merely a mode of making and using what is claimed.” Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 928 (Fed.Cir.1990).

2. Analysis of the ’938 Patent

Merck argues that the ’938 patent is invalid as a matter of law because it fails to describe the best mode process known to the inventors at the time they filed the patent application. Merck contends that the admissions of the inventors and experimental data demonstrate that there is no dispute of material fact regarding critical components of the patented process that were known and used by the inventors before they filed their application for the patent. When Sander and Cook filed their patent application, Merck contends, they knew of a mode of practicing their claimed invention that they considered to be better than any other. According to Merck, the inventors failed to set forth those known critical parameters in their patent specification, contrary to their legal obligation to do so.

In support of this argument, Merck points to the inventors’ “process data” sheets, which contain contemporaneous records of the inventors’ efforts to carry out the process of agglomerating gum with a particulate carrier. The inventors have testified about the entries on those data sheets, Merck notes, and have admitted that information which was critical to execution of the process does not appear in the patent and, further, that some of the information contained in the patent is wrong. Merck contends that the inventors’ improvements to their process, as shown in the “process data” compiled prior to the filing date of the patent (but not disclosed in the ’938 patent), constitute “indisputable evidence” of what was, at the time, the best mode of performing their invention. (Defendant’s Motion and Supporting Memorandum for Summary Judgment of Invalidity under U.S.C. § 112 for Failure to Enable the Best Mode of Carrying Out the Invention (“Defendant’s Best Mode Memorandum”), at 9.) Specifically, the “process data” sheets from the Insta*Thick X-10 agglomeration runs reveal, Merck insists, how the inventors developed additional conditions to optimize their process. Merck notes that these optimum process conditions used in the Ins-ta*Thiek X-runs are not sufficiently disclosed in the patent itself to enable one skilled in the art to use the invention.

Merck regards as particularly significant the inventors’ improvements to their process, as reflected by the process data recorded at different times prior to the filing of the patent application. For instance, entries on process data sheet H132001 reflect settings and adjustments to the Glatt WSG 120 used in performing the process of the claimed invention on November 16, 1981. Most of these settings and adjustments, however, were not disclosed in the patent itself. As noted by Merck, Sander indicated that these settings represented the best processing conditions that he knew in November 1981, and that any improvements to this process would be reflected in subsequent process data sheets. (Id. at 10.)

Merck contends that at least eight of the twelve critical operating parameters used by Cook and Sander to carry out their invention are not mentioned in the patent’s claims. Merck identifies the following missing parameters: (1) the manufacturer, brand, partiele size, and quantity of gum and particulate carrier used; (2) the amount, composition, and rate of application of the binder solution, atomizing air pressure; and (3) the settings for nozzle height and spray angle. Since these parameters are critical for one skilled in the art to achieve what Sander and Cook did, Merck urges that no genuine issue of material fact exists as to the conclusion that the patent is invalid for failing to meet the “best mode” requirement of 35 U.S.C. § 112.

In addition, Merck contends that subsequent process data reveals that Sander and Cook not only contemplated, but practiced, a better mode of carrying out their claimed invention than they disclosed in their patent. Merck quotes from a portion of a document written by Sander and Cook about their success at optimizing the agglomeration process between January and August in 1983. Although they could have incorporated their improvements into their application before filing it on August 17,1983, Sander and Cook did not do so. The co-inventors wrote in 1983 that one of their objectives in performing three agglomeration runs on January 14, 1983 was to “establish optimum process conditions which would produce an acceptable product within a 30-minute run time.” (Ex. 16 to Merck’s 12(m) Best Mode Statement, at 6.) The process data sheets which have been produced demonstrate that by June 17, 1983 (two months before the filing of the application), Sander and Cook had in fact achieved reproducible full capacity (200 pounds per run) agglomerations of 20 percent xanthan gum and 80 percent particulate carrier in the WSG 120 within 30 minutes. (Ex. 11 to Merck’s 12(m) Best Mode Statement.) Because these later run sheets reveal a more efficient process than that produced during the inventors’ first agglomeration run in 1981, Merck argues that the inventors were required to disclose the particulars of that process in the August 1983 patent application.

According to Merck, the evidence demonstrates that the inventors “concealed” their preferred mode from the public. Merck asserts that the level of skill in the art in 1983 was such that the undisclosed operating conditions were critical to carrying out the best mode of the claimed invention (i.e., the process of intermittently wetting and drying gum and particulate carrier in a fluidized bed condition created by a gaseous stream). (Defendant’s Best Mode Memorandum, at 12.) Merck observes that both Sander and Cook complained that the Glatt Manual did not explain the agglomeration process in sufficient detail to agglomerate satisfactorily. (Defendant’s Best Mode Memorandum, at 13.) The Glatt Manual, in fact, directed specifically that the operator devise his own operating conditions to obtain optimum agglomeration: “To obtain the best results, one must find out the suitable way.” (Ex. 7 to Merck’s 12(m) Best Mode Statement, at 05-004.) According to Cook himself, the patent identified only four of the twelve operating parameters that he regarded as critical for carrying out the patented process; arid one of these four disclosed parameters contained a significant error. See supra note 7 and accompanying text. Even Sander, with his considerable expertise in the art, acknowledged that agglomerating gum and particulate carrier in the Glatt WSG 120 was not a simple process: “There’s a whole myriad of things that come in when you look at putting a product in a fluid-bed dryer. It ain’t a piece of cake.” (Ex. 4 to Merck’s 12(m) Best Mode Statement, at 247, In. 5-7.)

As further support for its contention that the patent failed to enable a person skilled in the art to carry out the best mode of the patented process, Merck argues that Example 1 (which contains the sole disclosure of any mode of performing the process claimed in the process) is inoperable. In an exchange between Cook and Merck’s attorney, Cook admitted that Example 1, as set forth in the patent, fails to enable the production of dispersible particles:

Q: What does that mean, the residence time of the particles under the spray nozzle was approximately 35 seconds following each 35 second spray interval? [Cook Dep., at 150, In. 9.]

A: I think the only way that could be done is if the fluid bed was stagnant.

Q: You’d have bowling balls moving around in there.

A: That’s correct. [Id. at 152, Ins. 10-16.]

Q: So that phrase is incorrect, isn’t it, since you weren’t making bowling balls?

A: It appears to be incorrect to me, yes. [Id. at 153, Ins. 2-4.]

(Cook Dep., Ex. 5 to Merck’s 12(m) Best Mode Statement.) While Merck admits that one skilled in the art could calculate some of the undisclosed parameters, Merck contends that “no one, other than by luck, would be able to duplicate” the inventors’ results from their disclosure. (Defendant’s Best Mode Memorandum, at 15.)

a. Failure to Disclose Operating Parameters of the Glatt WSG 120

Zumbro admits that the ’938 patent does not disclose certain parameters used in the operation of the Glatt WSG 120 machine, but argues that such parameters are extrinsic to Sander’s conception of his invention. (Plaintiffs Response to Merck’s Motion for Summary Judgment of Invalidity for Failure to Disclose the Best Mode (“Plaintiffs Best Mode Response”), at 8.) Zumbro contends that the inventors did not direct any claims in their patent application toward the optimization of operating a Glatt WSG 120 machine or any other fluid bed dryer, the agglomeration of preliminary blend of 20% xanthan gum and 80% maltodextrin, completion of the process in under 80 minutes, or reproduction of the product. Id. Zumbro argues that the claimed invention is precisely what the patent describes: a process that results in “intermittently drying and wetting in a fluidized bed condition created by a gaseous stream.” Id. at 9. The specification teaches this process, Zumbro contends, rather than “a process particular to the Glatt WSG 120, as asserted by Defendant.” Id.

Thus, Zumbro’s principal contention in opposition to Merck’s motion is that the patentee’s “best mode” obligation does not extend to requiring that Sander and Cook identify in their patent the make, size, and operating parameters of the fluid bed dryer. In support, Zumbro relies upon Mendenhall v. Astec Indus. Inc., 14 U.S.P.Q.2d 1134, 1140, 1988 WL 193214 (E.D.Tenn.1988), aff'd, 891 F.2d 299, 891 F.2d 299 (Fed.Cir.1989). In Mendenhall, the court found no best mode violation where the patent failed to disclose the particular computer and computer program used in the commercial embodiment of a patent for the method of weighing and dispensing material from a surge bin of an asphalt plant. The court found no evidence that disclosure of the patent would not enable one conversant with programming microprocessors to develop a similar system to perform the steps of the patent. The court considered as “significant that it is not [the computer manufacturer’s] hardware or software that is protected in the weighing patent but simply the method of weighing and dispensing material from a surge bin.... ” 14 U.S.P.Q.2d at 1140. Finally, the court noted that the computer circuitry required to practice the invention was well within the skill of the art at the time of the invention. Id.

Zumbro suggests that requiring the inventors here to set forth all of the operating parameters they developed for agglomerating a particular blend of gum and maltodextrin in a particular brand of machine would be equivalent to requiring the patentee in Mendenhall to have set forth his computer program in full. Zumbro insists that the steps to be taken with any fluid bed dryer were within the skill of one versed in the art. Accordingly, Zumbro argues, the patentees had no obligation to “provide a tutorial” concerning the Glatt WSG 120 machine. (Plaintiffs Best Mode Response, at 10.)

The facts of Mendenhall are distinguishable from the circumstances presented here, however. Computer programs need not always be disclosed to fulfill the best mode requirement; if the patent furnishes the information necessary to write such programs, “there would seem to be no cogent reason to require disclosure of the menial tools known to all who practice this art.” See In re Sherwood, 613 F.2d 809, 817 n. 6 (C.C.P.A.1980) (“[T]he conversion of a complete thought (as expressed in English and mathematics, i.e., the known input, the desired output, the mathematical expressions needed and the methods of using those expressions) into the language a machine understands is necessarily a mere clerical function to a skilled programmer.”), cert. denied, 450 U.S. 994, 101 S.Ct. 1694, 68 L.Ed.2d 193 (1981). Zumbro has presented no evidence, however, that the operating parameters of the Glatt WSG 120 fluid bed dryer constitute clerical functions or obvious, mere menial tools to one seeking to duplicate the patented agglomeration process. To the contrary, Zumbro’s own witness has testified that the operating parameters were “critical”; and unrebutted evidence demonstrates that determining the optimum parameters was a goal of Sander’s and Cook’s efforts prior to August 1983. Zumbro has presented no evidence to support a conclusion that these optimum parameters were well known to one skilled in the relevant art.

Plaintiff has also cited Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544 (Fed. Cir.1987), vacated on other grounds, 486 U.S. 800, 108 S.Ct. 2166, 100 L.Ed.2d 811 (1988), for the proposition that the scope of the “best mode” requirement encompasses only the claimed invention at the time of the filing of the patent application. Although Plaintiff cites to the Federal Circuit opinion, the “best mode” discussion was revisited in a later decision by the Seventh Circuit. 870 F.2d 1292 (7th Cir.1989), cert. denied, 493 U.S. 822, 110 S.Ct. 81, 107 L.Ed.2d 47 (1989). Following a circuitous dispute concerning which court properly had jurisdiction over the case, the Seventh Circuit eventually considered the question of whether patents on rifle parts violated the best mode requirement by failing to disclose specifications and tolerances necessary to make parts interchangeable with M-16 rifles already in existence. The Christianson court observed that the scope of the patents extended to improvements in parts used in any rifle, not specifically M-16s. Id. at 1301-03. Because the best mode for making and carrying out the claimed inventions did not involve either the M-16 rifle or interchangeability with M-16s, the Seventh Circuit reversed the district court’s grant of summary judgment for plaintiffs. Instead, the court found that summary judgment should be entered declaring that defendant rifle manufacturer had disclosed the best mode of carrying out its inventions. 870 F.2d at 1302-03.

Christianson is distinguishable from the circumstances here as well. Even though the ’938 patent does not explicitly mention all of the “critical parameters” described by Defendant for the agglomeration process, Inventor Cook explicitly acknowledged that such undisclosed parameters were part of his invention. The settings and adjustments recorded on the process data sheets of runs subsequent to H132001, in fact, underscore the parameters that Sander and Cook actually deemed critical in carrying out the process of their invention.

Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524 (Fed.Cir.), cert. denied, 484 U.S. 954, 108 S.Ct. 346, 98 L.Ed.2d 372 (1987), a case cited by Defendant, presents circumstances more analogous to those here. In Spectra-Physics, the Federal Circuit considered whether a patent directed to a method of fabricating an ion laser was invalid for failure to disclose the best mode, based on a complete lack of detail about a six-stage braze cycle necessary to the enjoyment of the invention taught by the patent. The court held that the laser patent violated the best mode requirement, even though the patent disclosed the inventor’s preferred brazing compound (TiCuSil — an copper silver eutectic) and his preferred securing process (brazing). Although the patent discussed brazing in general, the court observed that the patent disclosed neither the actual brazing cycle with TiCuSil nor any of the parameters which the patent holder found to be its best mode. Id. at 1537. .

[The patent holder] admits that its [process] is not disclosed in [its] patent nor is it contained in the prior art. Instead, it maintains that its [process] is unique to its [processing equipment], and because the performance of [such equipment] varies considerably, the actual parameters would be meaningless to someone who used a different [brand of equipment].

Id. at 1536. The court was not persuaded by this argument, one nearly identical to Zumbro’s. In Spectra-Physics, the court concluded that the patent’s complete lack of detail about the brazing process “effectively resulted in [the patent holder’s] concealment.” Id. at 1537. See also Deep Welding, Inc. v. Sciaky Bros., Inc., 417 F.2d 1227, 1241 (7th Cir.1969) (process patents in “crowded” areas of prior art must have a preciseness of description; language of the patent must tell the operator of a machine who desires to perform the process exactly how to proceed so as to perform successfully), cert. denied, 397 U.S. 1037, 90 S.Ct. 1354, 25 L.Ed.2d 648 (1970); Pennsylvania Crusher Co. v. Bethlehem Steel Co., 193 F.2d 445, 448-49 (3d Cir.1951) (claim in process patent must include all necessary occurrences in the process; size range of material and length of hammers must be disclosed in order for hammermill operator to know when he has attained substantial penetration of particles falling into that part of a hammer cylinder traversed by hammers). Similarly, Cook’s and Sander’s limited disclosure of the Glatt WSG 120 operating parameters can also be deemed to result in unlawful concealment.

Wahl Instruments, Inc. v. Acvious, Inc., 950 F.2d 1575 (Fed.Cir.1991), a ease which was decided after the parties’ briefing here, also involved a dispute over the best mode of carrying out an invention in a motion for summary judgment. The Wahl court instructed that a patent need not describe all facets of the manufacturing process in order to satisfy the best mode requirement. To determine whether that requirement has been met, the court cannot apply a “mechanical rule” but must consider “the scope of the invention, the skill in the art, the evidence as to the inventor’s belief, and all of the circumstances____” Id. at 1580.

The patent in Wahl concerned an egg-timer made out of thermoehromic and temperature indicating materials. Id. at 1577. The patent specification stated that the device may be ultrasonically welded or joined by adhesive or by “ ‘any other suitable or desirable means for [bonding the materials].’ ” Id. at 1580 (quoting the language of the patent). In manufacturing the device, the inventor used an embedment molding technique which was not described in the patent. Plaintiffs former employee began a business making a competitive egg-timer. In a lawsuit- charging the former employee with infringement, the court granted summary judgment on the ground that the patent’s failure to disclose the specific embedment molding method for manufacturing the product violated the best mode requirement. In reversing that determination, the Federal Court observed that a description of the particular technique selected to manufacture a device may or may not be needed to comply with the best mode requirement. Id. at 1579. The Wahl court stated:

[T]he particulars of making a prototype or even a commercial embodiment do not necessarily equate with the “best mode” of “carrying out” an invention. Indeed, the inventor’s manufacturing materials or sources or techniques may vary from wholly irrelevant to critical. For example, if the inventor develops or knows of a particular method of making which substantially improves the operation or effectiveness of his invention, failure to disclose such peripheral development may well lead to invalidation. On the other hand, an inventor is not required to supply “production” specifications.

Id. at 1579-80 (citations omitted). Finding that the information missing from the patent application (e.g., the embedment molding) “was no more than a routine manufacturing choice,” the circuit court found that the grant of summary judgment was improper. Id. at 1580.

The court’s holding in Wahl is instructive because it, too, involves both a process patent and an infringer which raises the best mode defense in a motion for summary judgment. Unlike the facts here, however, the patentee in Wahl could point to testimony by the inventor demonstrating his own uncertainty at the time of filing of the patent application as to the best method. Cook, by contrast, has admitted that certain critical parameters that he did know were missing from the patent specifications. Another distinction between Wahl and the present case is the significance of the information omitted from the patent specifications: the Wahl court regarded the missing embedment information as “no more than a routine manufacturing choice”; here, by contrast, Cook himself has acknowledged the eight parameters absent from the patent as “critical.” Sander and Cook both wrote in 1983 that one of the objectives of their three agglomeration runs was to find optimal process conditions. Zumbro has not effectively challenged Merck’s contention that, having identified those optimal conditions, Sanders and Cook were required to reveal them.

b. Whether Zumbro Has Shown a Genuine Dispute of Material Fact

A party seeking a summary judgment of invalidity bears a heavy initial burden, because an issued patent carries a statutory presumption of validity under 35 U.S.C. § 282. Tillotson, Ltd. v. Walbro Corp., 831 F.2d 1033, 1036 (Fed.Cir.1987). To overcome that burden, courts have required the movant to establish the invalidity through clear and convincing evidence. Id. Once a sufficiently supported motion for summary judgment has been submitted, however, the burden of coming forward and showing that there is a genuine dispute of a material fact shifts to the non-moving party. Scripps Clinic & Research Found, v. Genentech, Inc., 927 F.2d 1565, 1571 (Fed.Cir.), reh’g denied, (1991). In order to meet such burden, the non-moving party must present “ ‘sufficient evidence supporting the claimed factual dispute ... to require a jury or judge to resolve the parties’ differing versions of the truth at trial.’ ” Id. (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986)). The need to inquire into the inventor’s state of mind, however, should “not per se preclude the granting of summary judgment on the best mode issue where there are no disputed issues of fact.” Acme Resin Corp. v. Ashland Oil, Inc., 20 U.S.P.Q.2d 1305, 1310, 1991 WL 274498 (S.D.Ohio 1991) (granting summary judgment where patent applicant failed to disclose preferred binder components in process for making foundry cores and molds for casting of metal), aff'd, 954 F.2d 735, cert. denied, — U.S. —, 113 S.Ct. 189, 121 L.Ed.2d 133 (U.S.1992). “ ‘If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.’ ” Scripps Clinic, 927 F.2d at 1571 (citations omitted).

Merck has demonstrated that inventors Cook and Sander omitted critical process parameters from the patent specification. In particular, the testimony of Cook acknowledging that the undisclosed process conditions constituted part of the invention is especially damaging to Plaintiff; Zumbro has made no effort to explain why this admission should be disregarded. Nor has Zumbro submitted any explanation for the written statements of Sander and Cook, made prior to the filing of the patent application in 1983, that they hoped “to establish optimal process conditions” in three agglomeration runs. Finally, Zumbro has not countered the evidence that its process data sheets show that Sander and Cook had, by the filing date, employed the parameters acknowledged by Cook to be critical in agglomerating xanthan gum with a particulate carrier in the Glatt WSG 120; yet these parameters are not set forth in the patent.

This evidence demonstrates that the patent specifications concerning the operating instructions for the Glatt WSG 120 during the agglomeration process were inadequate to comply with best mode requirements. The Glatt Manual itself states that one must seek out the “most suitable way” in order to obtain best results. The very lack of instructional guidance for operating the Glatt WSG 120 tends to show that without identification of specific parameters, the patented agglomeration process cannot be performed without undue experimentation from known materials. See Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1211 (Fed.Cir.) (lack of sample of biological cells does not constitute failure to comply with best mode requirement if cells can be prepared without undue experimentation from known materials, based on patent description), cert. denied, — U.S. —, 112 S.Ct. 169, 116 L.Ed.2d 132 (1991).

Zumbro “has set forth no facts to exhibit a dispute about whether the ... best mode requirements, properly understood, were fulfilled by [Sander’s and Cook’s] patent[].” Christianson, 870 F.2d at 1303. Although Zumbro has intimated that one “skilled in the art” would be familiar with the specific critical parameters, it has offered no evidence that this is so. Similarly, Zumbro asserts that it need not set forth operating parameters because the patent application did not direct any claims to optimizing operation of a Glatt WSG 120 machine, or any other fluid bed dryer; yet Zumbro has not submitted any affidavits or other materials to suggest that such a machine was not indispensable to successful execution of the patented process. Indeed, Zumbro has presented no evidence that the experiment could have been performed successfully using another brand of dryer. Zumbro suggests that successful agglomeration can be achieved through trial and error; yet Zumbro provides no affidavits showing that an individual skilled in the operation of fluid bed dryers could determine the optimal operating parameters without excessive experimentation. Finally, Zumbro has remained silent on the question of why Sander’s adjustments to the process subsequent to the H132001 run do not appear anywhere in the patent.

The court can conceive of numerous potential disputes not addressed by either party. The court is sensitive to these potential issues; it is sensitive as well, however, to its proper role here: to determine whether Defendant has demonstrated the absence of any disputes of material fact regarding the “best mode” requirement. In Dana Corp. v. IPC Ltd. Partnership, 860 F.2d 415, 420 (Fed.Cir. 1988), cert. denied, 490 U.S. 1067, 109 S.Ct. 2068, 104 L.Ed.2d 633 (1989), the Federal Circuit found a violation of the best mode requirement where a valve stem seal patent failed to disclose an unclaimed fluoride surface treatment that was necessary for satisfactory performance. The court observed that the applicant’s own letter and testimony concerning the applicant’s first sales of seals presented uncontroverted and corroborating evidence that at the time of filing, the inventor believed that the best method of carrying out his invention included fluoride treating surface of seals with fluoride. “Having no evidence to the contrary to consider, reasonable minds could not have differed as to whether [the inventor] believed that [an undisclosed step in carrying out the patent] was part of the best mode of carrying out the claimed invention.” Id. at 420.

Similarly, here, Zumbro has failed to provide evidence to dispute whether Cook and Sander believed the critical parameters absent from the patent constituted part of the best mode. Because there are no genuine issues of material fact remaining on the issue of best mode, summary judgment should be entered for Merck.

Recommendation

Defendant’s motion for summary judgment of invalidity based on Plaintiff’s failure to comply with the “best mode” requirement should be granted.

MERCK’S MOTION FOR SUMMARY JUDGMENT ON GROUNDS OF VIOLATION OF “ON SALE” BAR OF 35 U.S.C. § 102(b)

At issue in Defendant’s motion for summary judgment is whether inventor Sander commercially exploited the method of the ’938 patent prior to the statutory one-year grace period (the “critical date”), in violation of the “on sale” bar of 35 U.S.C. § 102(b).

A. Facts Relating to “On Sale” Motion

Zumbro filed its patent on August 17, 1983 with the United States Patent and Trademark Office. Under 35 U.S.C. § 102(b), the inventor of a patented product or process is prohibited from commercial exploitation of the invention more than one year before the filing of the patent application. An inventor who violates this prohibition renders the invention ineligible for a patent. The purpose of this prohibition against prior sales by the patentee — referred to as the “on-sale” bar — is to encourage disclosure of inventions by preventing the inventor from extending his or her period of protected patent monopoly longer than the one-year statutory “grace period.” The critical date here for “on sale” activity relating to the ’938 patent is one year before the filing of the application for the subject invention — thus August 17, 1982.

In this motion, Merck contends that the method was commercially exploited prior to the “critical date” and that Zumbro is therefore barred from enforcing its patent. Merck identifies two sets of circumstances as events that constitute placing the method “on sale” in violation of § 102(b). The facts involved are set out separately below.

1. Run No. H132001

Sander and Cook first reduced their invented method to practice with the fluid bed dryer run, referred to here as “Run No. H132001,” on November 16, 1981. Prior to that date, on June 30, 1981, Kelco had shipped twenty-five pounds of xanthan gum to Sander at the Grain Processing Corporation. On November 16, 1981, using the method, twenty-five pounds of xanthan gum (a vegetable gum), and 100 pounds of maltodextrin 100 (a food grade particulate carrier), were agglomerated to form 125 pounds of agglomerated xanthan gum and maltodextrin. At his deposition, Sander was asked whether Run No. H132001, as performed on November 16, 1981, reflected a method that employed each specific step of Claim 15 of the ’938 patent. When questioned specifically about each individual step, Sander responded affirmatively.

Sander also admitted that at that time Kelco was a targeted customer. He stated that he “was trying to” sell to Kelco when he reduced his invention to practice and that he “wanted to sell Kelco at that time.” Sander was asked, “You wanted to have Kelco become a customer for your custom processing, correct?” Sander responded, “That’s right.” (Ex. U to Merck’s 12(m) On Sale Statement, at 158, In. 12-18.)

Zumbro has admitted that IFP sent samples of agglomerated maltodextrin to customers to interest them in utilizing IFP as a custom processor, although the record does not establish when this occurred. (Zumbro’s 12(n) On Sale Statement, ¶ 44.) Sander states that he provided Kelco with the product produced by the method of his invention so that Kelco could “look at” it. Sander recalled his dealings with Kelco as an effort to convey this information: “We made the invention happen. We said, hey, look at this. It works.” It is undisputed that Sander or IFP sent Kelco the batch, known as Run No. H132001, or most of the batch, or a sample of it, in an effort to interest Kelco in IFP’s custom processing. A Kelco laboratory notebook issued to Howard Wright, Jr. (apparently a staff scientist at Kelco) indicates that on January 22, 1982, Kelco evaluated a sample of IFP’s product known as Run No. H132001. Zumbro’s counsel stipulated that the reference to Run No. H132001 in Wright’s notebook, was “Zumbro [IFP] material” and that “that batch was sent out [by IFP] to Kelco.”

In response to Merck’s 12(m) On Sale Statement, Plaintiff has offered this additional information: From 1981