The opinion of the court was delivered by: REBECCA R. PALLMEYER
Judge Charles R. Norgle, Sr.
Magistrate Judge Rebecca R. Pallmeyer
Standard for Summary Judgment in a Patent Case
Merck's Motion for Summary Judgment on Grounds of "Best Mode" Violation
A. Facts Relating to Best Mode
B. Analysis of "Best Mode" Motion
1. Standards for Proving Violations of Best Mode
2. Analysis of the '938 Patent
a. Failure to Disclose Operating Parameters of the Glatt WSG 120
b. Whether Zumbro Has Shown a Genuine Dispute of Material Fact
Merck's Motion for Summary Judgment on Grounds of Violation of "On Sale" Bar of 35 U.S.C. § 102(b)
A. Facts Relating to "On Sale" Motion
B. Analysis of "On Sale" Motion
1. Standards for Proof of "On Sale" Activity
2. Analysis of Defendant's Claim that Sander and Cook Violated the "On Sale" Bar of 35 U.S.C. § 102(b)
a. Did IFP Offer Its Custom Processing for Sale by Providing Kelco with a Sample of the Product of Run No. H132001?
b. Was Run No. H220801 (Unifiber) Produced by the Method of Claims 1 and 15 of the '938 Patent?
(i) P 27 of Merck's Local Rule 12(m) On Sale Statement
(ii) P 28 of Merck's Rule 12(m) On Sale Statement
Motions For Summary Judgment of Validity, Infringement and Non-Infringement
A. Facts Relating to Validity and Infringement
B. Analysis of Zumbro's Motion for Summary Judgment of Validity
1. Pertinent Prior Art Patents Not Considered by the Patent Examiner
2. Invalidity of Claims 26 and 27 Based on Uncited Pertinent Prior Art
3. IFP's Agglomeration for T.J. Lipton Prior to the Critical Date
C. Analysis of Zumbro's Motion for Summary Judgment of Infringement
1. Standards for Summary Judgment of Infringement
(i) The Meaning of "Intermittent Spraying"
(ii) Internal Operation of the WSG Process and the GPCG Process
(iii) Absence of Particulate Carrier in Keltrol RD
D. Analysis of Merck's Motion for Summary Judgment of Non-Infringement
1. Whether Zumbro's Claims Require Both a "Vegetable Gum" and a Separate "Food Grade Particulate Carrier"
2. The Specification's Differentiation of "Particulate Carrier" and "Vegetable Gum"
a. Definition of "Food Grade Particulate Carrier"
b. Function of the Food Grade Particulate Carrier
c. May Limitations Be Read into the Claims?
3. The Inventors Admissions Concerning the Specification's Silence about "Vegetable Gum" Constituting a "Particulate Carrier"
4. The Prosecution History of Claims 26 and 27
REPORT AND RECOMMENDATION
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 pretrial matters. The referral was transferred to these chambers pursuant to order of the Executive Committee dated October 10, 1991.
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 (1988); Flow-Rite of Tennessee, Inc. v. Sears Roebuck & Co., Inc., 20 U.S.P.Q. 2d 1361 (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 conclusory statements are not sufficient. Jamesbury Corp., 839 F.2d at 1548.
The panties 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 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, P 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 "typically, 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
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.
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, P 54, Zumbro's 12(n), P 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 Aeromatic, 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: "You 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, PP 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*Thick 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 co-authored "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.)
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 "as 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, lns. 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, P 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, lns. 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, lns. 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, lns. 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, P 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, 112 S. Ct. 169 (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 (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 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 (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, 870 F.2d 1292, 1301 (7th Cir.), cert. denied, 493 U.S. 822 (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 Insta*Thick 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, particle 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; and 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, ln. 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 ...