Full opinion text
RULING ON MOTION FOR PRELIMINARY INJUNCTION ELLEN B. BURNS, Senior District Judge. This infringement action involves United States Patent No. 4,135,622 (“the ’622 patent”), entitled “Packaged, Desiccated Surgical Elements,” which was issued on January 23, 1979 to American Cyanamid Company (“Cyanamid”) as assignee of the inventor, Arthur Glick. This Court has jurisdiction over the subject matter under 28 U.S.C. § 1338(a), and venue is proper under 28 U.S.C. § 1400(b). Cyanamid has moved for an order enjoining United States Surgical Corporation (“U.S. Surgical”) pendente lite from making, using, or selling packaged synthetic absorba-ble sutures that infringe the ’622 patent, which are marketed by U.S. Surgical under the brand name Polysorb. After an eight-day hearing to the Court, the parties’ filing of post-hearing memoranda with proposed findings of fact and conclusions of law, and oral argument, and after considering the sufficiency, weight, and credibility of the testimony of the witnesses, their demeanor on the stand, the documentary evidence admitted at the hearing, and the post-hearing memoranda, the Court enters the following findings of fact and conclusions of law, which are embodied in this opinion as permitted by Fed.R.Civ.P. 52(a). For the reasons that follow, the Plaintiffs motion for a preliminary injunction is denied. FINDINGS OF FACT I.BACKGROUND A. The Parties 1. Plaintiff American Cyanamid Company is a corporation organized and existing under the laws of the State of Maine with a place of business at Stamford, Connecticut. Cyanam-id manufactures and sells a variety of chemical, agricultural, and medical products with sales in 1990 of $4.5 billion. (Compl. ¶ 3; DX BT). 2. Cyanamid, through its Davis & Geek division, manufactures and sells a competitive full-line of sutures used in medical surgical procedures. Cyanamid also markets other wound closure products, including external skin staplers and stainless steel needles. (Clifford Tr. 1188, 1190, 1192; PX 75 (IMS Market Data for Fixed Head and Rotating Head Skin Staplers); PX 83, at 20 (Cyanam-id Annual Report (1990))). Davis & Geek’s worldwide sales in 1990 were approximately [[ ]] (Clifford Tr. 1191). 3. U.S. Surgical is a corporation organized and existing under the laws of the State of Delaware with its principal place of business in Norwalk, Connecticut. U.S. Surgical manufactures and sells a variety of competitive wound closure products and endoscopic instruments, including internal and external surgical stapling instruments, surgical clips, clip appliers, and trocars. (Knarr Tr. 1757-58; PX 82 (U.S. Surgical Annual Report (1990))). In March 1991 U.S. Surgical introduced a full-line of suture products, which are manufactured at its principal manufacturing facility in North Haven, Connecticut. (Knarr Tr. 1758, 1762-62; DX BQ). 4. U.S. Surgical has grown rapidly in recent years. From 1987 to 1990, its annual sales doubled from $252 million to $514 million, and sales for the first three quarters of 1991 exceeded $600 million. (Knarr Tr. 1758-59; PX 82, at 43). B. The Witnesses 5. The following witnesses testified in behalf of Cyanamid in its case-in-chief or in rebuttal: Gabor B. Levy, Ph.D., a consultant in the scientific instruments field and editor of American Laboratory and Biotechnology Lab (PX 9); Elvira Longordo, Ph.D., an employee in the physical chemistry laboratory of the Scientific Services Department of Cyanamid; A. Charles Tanquary, Ph.D., a polymer chemist with over 35 years of experience in the field of polymer research and technology (PX 62); William K. Brandt, Ph. D., a marketing and sales management consultant (PX 74); John F. Clifford, Division Vice President of the Davis & Geek division of Cyanamid; Leo Gaudette, a Regional Sales Manager of the Davis & Geek division of Cyanamid; Dean Gulezian, a Sales Representative for the Davis & Geek division of Cyanamid; Martin Adelman, Professor of Law at the Wayne State University School of Law and editor of Patent Law Perspectives (PX 73); Michael Zeide, M.D., an orthopedic surgeon practicing in West Palm Beach, Florida; Chermeine Rivera, a chemist employed by Cyanamid; and Peter K. Jarrett, Ph.D., Associate Research Fellow of the Polymer Technology Group of Cyanamid. 6. The following witnesses testified in behalf of U.S. Surgical in opposition to the motion for a preliminary injunction: John R. Schaefgen, Ph.D., a consultant in the field of polymer chemistry with over 30 years of experience (DX T); David M. Wiles, Ph.D., a consultant and former head of the Division of Chemistry of the National Research Council of Canada with over 30 years of experience studying the kinetics of polymer reactions (DX U); Richard R. Geoffroy, an engineer with over 25 years of experience in test method development (DX S); John D. Cor-bitt Jr., M.D., Chairman of the Department of Surgery at J.F.K. Medical Center (DX Q); Donald S. Chisum, Professor of Law at the University of Washington School of Law and author of a seven-volume treatise on patent law (DX R); Donald Kaplan, Ph.D., U.S. Surgical’s Vice President of Materials Research who developed the accused product, Polysorb; and Robert Knarr, U.S. Surgical’s Vice President of Marketing. C. General Information — Sutures 7. There are seven types of sutures: catgut, silk, nylon, polypropylene, steel, Dacron, and synthetic absorbable. Sutures are manufactured in many different sizes and are typically dyed, coated, and needled. (Tan-quary Tr. 541-42; Knarr Tr. 1760-61; DX BQ). 8. A synthetic absorbable suture is made principally of a synthetic polymer, which is designed to hold tissue together for only a few weeks while healing occurs. Body moisture then breaks down the synthetic absorba-ble suture into components that the body can metabolize. (Tanquary Tr. 541; Kaplan Tr. 820; Wiles Tr. 1377-78; Knarr Tr. 1780). As such, synthetic absorbable sutures must retain stability and in vivo strength, yet deteriorate after the critical wound healing process. (Wiles Tr. 1378; Tanquary Tr. 550). 9. The term “synthetic polymer” refers to a long chain of material comprising small chemical building blocks usually made from petrochemical sources. (Tanquary Tr. 541; Kaplan Tr. 731; Wiles Tr. 1376-77). 10. Synthetic absorbable sutures are broken down in the body by a process called hydrolytic degradation. In this process, water attacks and breaks the ester linkages in the polymer chain to facilitate absorption into the body. (Tanquary Tr. 541, 549-50; Wiles Tr. 1378-79). D. The ’622 Patent 11. The ’622 patent relates to packaged synthetic absorbable surgical elements. Claim 1 of the ’622 patent provides: A package comprising an air-tight sealed container fabricated from a material which is substantially impervious to water vapor, said container having therein a storage stable sterile synthetic surgical element of a polymer subject to hydrolytic degradation to non-toxic, tissue-compatible absorb-able components, said polymer having gly-colic acid ester linkages, said storage stable sterile synthetic surgical element further characterized in that the absorbed water moisture in the sterile surgical element is at or less than 0.25% by weight of the sterile surgical element, in the sterile enclosure. (PX 1, col. 21, 11.15-27; DX DP). E. Polysorb 12. Dr. Donald S. Kaplan, Vice President of Research at U.S. Surgical, developed the Polysorb synthetic absorbable suture. (Kap-lan Tr. 745, 772-73). 13. Polysorb is packaged in an airtight, water impervious foil package. (Kaplan Tr. 815; Tanquary Tr. 554; PX 64; PX 65). 14. Polysorb is a sterile synthetic absorb-able suture composed primarily of a 90/10 copolymer of glycolic and lactic acids. (Kap-lan Tr. 809, 828; Wiles Tr. 1376-77; Tan-quary Tr. 555; PX 64). 15. Polysorb has glycolic acid ester linkages, (Wiles Tr. 1496), and also contains glycerin, a terpolymer coating, and water. 16. Polysorb is storage stable and subject to hydrolytic degradation to non-toxic tissue compatible absorbable components. (Tan-quary Tr. 555-56; Wiles Tr. 1495; PX 64; PX 65). 17. After interpreting the meaning of surgical element, a principal issue is thus whether “the absorbed water moisture in the sterile surgical element is at or less than 0.25% by weight of the sterile surgical element.” 18. The filaments in Polysorb are more numerous and smaller in diameter than those in competitive products, and they are braided differently, with an inner core of filaments and an outer braided portion. (Kaplan Tr. 750-59; Tanquary Tr. 562; Wiles Tr. 1376; PX 66; DX DU; DX DV; DX DW). 19. The glycerin, water, and 90/10 copo-lymer are in dynamic equilibrium within the Polysorb package. (Wiles Tr. 1393; DX FY). These components move rapidly throughout the system and hydrogen bond with each other in multiple configurations. (Wiles Tr. 1389, 1391-93, 1403, 1408-11, 1434-36, 1450-51). 20. This equilibrium and interaction “no longer allows you to differentiate between water that’s part of glycerin or water that’s part of the polymer or water that’s part of itself.” (Wiles Tr. 1403, 1451, 1480-81). Consequently, the relative hygroscopicity of water, glycerin, and the 90/10 copolymer, standing alone, will not apply in a system where water, glycerin, and the 90/10 copo-lymer are mixed together. (Wiles Tr. 1402-03, 1479-82). 21. The 90/10 copolymer of glycolic and lactic acid has crystalline and amorphous regions. (Kaplan Tr. 740, 810, 827, 911). 22. The crystalline regions lie randomly throughout the molecular structure of the suture filaments. (Kaplan Tr. 910). Within the crystalline regions, however, the molecules are in a tightly bound orientation so that essentially no spaces exist between the molecules. (Kaplan Tr. 740; Wiles Tr. 1365-66). Between the crystalline regions lie amorphous regions, which are “flexible spaghetti-like chains” without orientation. (Kaplan Tr. 740-41, 911; Wiles Tr. 1366). The crystalline regions in Polysorb “range from the high 30 percent level to 40[-]45 percent level,!’ (Kaplan Tr. 810, 910), and the remainder is amorphous. (Kaplan Tr. 810). Both water and glycerin can enter the amorphous (but not the crystalline) regions of the polymer. (Kaplan Tr. 810, 911; Wiles Tr. 1393-94, 1475). 23. Crystallinity increases as the structure becomes closer to a homopolymer. (Kaplan Tr. 826-27). Although the crystal-linity levels of a 100 percent homopolymer are slightly greater than those of a 90/10 copolymer, (Kaplan Tr. 740-41), Dr. Kaplan “found almost no differences in their behavior in terms of tensile strength or any other characteristics.” (Kaplan Tr. 828-29). 24. Dr. Kaplan decided to use a 90/10 copolymer not only because of the absence of significant differences in its characteristics as compared to the homopolymer but also because the “90/10 is soluble in solvents that the 100 percent material is not, and it [was therefore] practical from a production point of view to have our products be soluble in solvents that are safe and easy to use in the manufacturing plant.” (Kaplan Tr. 828). 25. The outside of the Polysorb suture is incompletely coated with a terpolymer comprising a mixture of glyeolide/lactide copo-lymer, polyethylene oxide, and calcium lactate. Compare (Kaplan Tr. 848-49, 852; Wiles Tr. 1380-81, 1384; PX 20; PX 64) (confidential) with (Longordo Tr. 245-46; Tanquary Tr. 555-57). The coating is designed to provide “rundown characteristics” that allow knots to slide down the suture in order to secure the tissue. (Kaplan Tr. 764-65). 26. Once the terpolymer coating is applied and disrupted by the suture’s passage between two rollers, glycerin is added in an amount equal to approximately 10% by weight of the suture. (Kaplan Tr. 773-75, 852). (confidential). In addition to providing the desired level of flexibility, that level of glycerin was selected in order to facilitate the smooth removal of the suture from the package. (Kaplan Tr. 775-77, 779, 918-20; PX 53). 27. At the level manufactured, the glycerin initially existing throughout the Polysorb suture structure (including the braid, core, and polymer), will not surround every fiber. Compare (Tanquary Tr. 563-64; Levy Tr. 165-66) with (Kaplan Tr. 811-13; Wiles Tr. 1384, 1394). Hence, although the glycerin will initially contact and fill spaces between the filaments in Polysorb through capillary action (Kaplan Tr. 847-48, 854-61; Wiles Tr. 1390-91) and the concentration gradient, there is an insufficient amount of glycerin in the Polysorb suture structure to fill all of the spaces between (and surround all of) the filaments. Once the capillary action has finished distributing the glycerin incompletely throughout the suture structure, “the present glycerin diffuses into the polymer itself.” (Kaplan Tr. 860; Wiles Tr. 1384, 1454-55). 28. An unmeasured (and perhaps unmeasurable (Kaplan Tr. 860-61)) amount of glycerin will enter the amorphous regions of the polymer structure in the Polysorb suture. Compare (Tanquary Tr. 598-99, 582) with (Kaplan Tr. 810-11, 860, 863-65; Wiles Tr. 1384, 1391, 1393-94, 1437, 1455-57, 1475). This diffusion into the polymer results from the concentration gradient, the amount of glycerin in the system, and the hydrogen bonding of glycerin and the polymer. (Kap-lan Tr. 860-61; Wiles Tr. 1391, 1437, 1452). All of the glycerin in the Polysorb suture system will be distributed at the molecular level, (Wiles Tr. 1408-09), with some molecules on the “surface,” “some just inside, some of it just a little bit farther inside ...,” (Wiles Tr. 1458), until there is no concentration gradient left. (Wiles Tr. 1458). 29. The rate of migration of a molecule will in part depend upon its size (or molecular weight). (Wiles Tr. 1483-84). Generally, “the rate of migration ... will be slower the larger the molecule gets.” (Wiles Tr. 1483). Although glycerol is a larger molecule than water, (Tanquary Tr. 598), and although a rate/size correlation exists, “it’s not a black or white thing. Big molecules will go [into the copolymer] as well. They’re all so much smaller than the polymer molecules that size isn’t as important as you might think,” (Wiles Tr. 1484), especially since “[tjhere are lots of unoccupied sites of ester carbonyl groups in the polymer molecules of which the filaments are made [that are] not occupied by either glycerin or water in the Polysorb recipe.” (Wiles Tr. 1453; see also Wiles Tr. 1394-95, 1449). The main force is the concentration gradient. (Wiles Tr. 1483, 1437-38). 30. The diffusion of the glycerin into the copolymer is a longer process than the capillary action of glycerin throughout the braided filament structure. (Kaplan Tr. 860) (“It doesn’t happen ... instantaneously.”); (Wiles Tr. 1394) (The migration of molecules into polymeric systems occurs “with time.”); (Wiles Tr. 1439) (testifying that, “if you give the experiment long enough time to run,” the same amount of glycerin will penetrate wood and sponge to the same degree). 31. In rebuttal, Cyanamid introduced the results of two sets of testing that were designed to show that no glycerin enters the polymeric portion of the suture, therefore concluding that glycerin does not act as a plasticizer. See (infra at 103). In the first set of testing, films of polygly-colic acid were immersed in 99.5% glycerol for time periods of 20-25 minutes. No weight gain was observed upon removal of the PGA films from the glycerol bath, after blotting dry and weighing the sample. (Rivera Tr. 2019-38); (Jarrett Tr. 2047). U.S. Surgical, however, contends that these tests are irrelevant because: (i) Cyanamid introduced no evidence to establish any correlation between the behavior of a film and a suture filament and (ii) Cyanamid introduced no evidence that the glycerin was applied under conditions resembling those under which the glycerin is applied to Polysorb sutures. (Rivera Tr. 2038-44). Of course, testimony from Cyanamid on this issue would have been helpful, but these criticisms alone would not necessarily have been a basis to find the testing inconclusive. However, the Court has a more specific concern with the conclusion to be drawn from the testing, which is subsumed in U.S. Surgical’s criticisms, but which is borne out by the record. As stated supra, the diffusion of glycerin into the copolymer occurs with time, and there is no evidence to suggest that glycerin does not actually enter the copolymer in a time period longer than 20-25 minutes, or that, if glycerin would enter the copolymer, it would have done so in the time period selected by Cyanamid. Consequently, this testing is inconclusive. At trial, tests on films and sutures, while taking into account the concerns of U.S. Surgical, over a variety of time periods may prove to be probative on this issue. In the second set of testing, Cyanamid used differential scanning calorimetry (DSC) to determine the glass transition temperature of the copolymer in Polysorb. (Jarrett Tr. 2066). The glass transition temperature of a polymer is that temperature at which the amorphous region of the polymer makes the transition from a crystal material to a rubbery material. (Jarrett Tr. 2066); (Kaplan Tr. 829) (“[I]t’s at the point where as you constantly increase the polymer’s temperature, it rapidly changes properties, changes in its hardness, it changes in its heat capacity, it changes in a lot of different [ways].”). Some polymers will have a specific glass transition temperature, (Jarrett Tr. 2067); (Wiles Tr. 1464), and, if that same polymer has a plasticizer added to it, the glass transition temperature will be altered and, depending upon the system, commonly goes down. (Jarrett Tr. 2067); (Wiles Tr. 1473-74). The glass transition temperature of untreated Polysorb sutures and Polysorb sutures treated with acetone or methylene chloride were determined, (Jarrett Tr. 2069-73), and Cyanamid found no difference in the temperatures, therefore contending that the glycerin does not penetrate the polymeric structure of the 90/10 copolymer in Polysorb. (Jarrett Tr. 2073-74). Cyanamid’s evidence may have been conclusive on this issue were it not for the testimony of Dr. Wiles, which was given earlier in the proceeding and before Cyanamid introduced its rebuttal evidence. Dr. Wiles testified that DSC is a difficult and technical procedure, especially when trying to determine the effect of a plasticizer in a polymer. He stated: [The glass transition temperature] is the measurement of the characteristics of the amorphous part of a semi-crystalline polymer. You get a transition from rigid, glassy-type material to a more fluidlike [sic] material. You can characterize semi-crystalline polymers by measuring their glass transition temperatures. But that requires that the measuring device and the measuring method should not in fact alter the composition of the material that you are studying, and that can be a problem. Because if you measure by thermal characteristics, you raise the temperature, you can drive off some of the components in here, which means ... your sample is no longer the way it was when you started. (Wiles Tr. 1463); see also (Wiles Tr. 1464). Dr. Wiles continued by saying that in theory there is supposed to be a characteristic temperature for each polymer, but it can be difficult to measure and it is not always the same. (Wiles Tr. 1466). As to Polysorb itself, Dr. Wiles testified: Once you have heated up a thing like Polysorb up to its melting point, you have driven off some of the plasticizers, some of the water is gone, some of the glycerin is gone. Now you are in trouble. You can’t melt out the thermal history of that without in fact driving off the very plasticizer whose presence you’re trying to find. (Wiles Tr. 1468); see also (Wiles Tr. 1469-70). Without taking into consideration the concerns of Dr. Wiles nor providing any rebuttal addressed to those concerns, the DSC testing is inconclusive. At trial, these and additional tests and testimony from the experts on the results and methodology may be probative. 32. The amount of glycerin within the suture structure does not affect the amount of moisture available to the polymeric portion of Polysorb at a given relative humidity. (Tanquary Tr. 576, 594-95; Kaplan Tr. 864-65, 900-01; Wiles Tr. 1395; Schaefgen Tr. 1702-04). 33. At a given relative humidity, however, the amount of absorbed moisture in a suture, such as Dexon or Polysorb, is a function of the composition of the suture (e.g., polygly-colic acid) and the physical characteristics of its structure, including its surface-to-volume ratio. (Kaplan Tr. 903-04). Hence, “the larger the surface-to-volume ratio, the larger the amount of water for any given material.” (Kaplan Tr. 903). 34. Without taking into account the differences in structure, components, filament size, and surface-to-volume ratios between Dexon and Polysorb, Table IV of the ’622 patent does not provide the amount of absorbed moisture in Polysorb (or the polymeric portion of Polysorb) at a given relative humidity, including the as-packaged relative humidity. Compare (Tanquary Tr. 574-76) with (Kaplan Tr. 902-04; Schaefgen Tr. 1706; PX 1, at cols. 17-18). 35. The Polysorb suture is attached to a needle and rests in a grooved tray. (Kaplan Tr. 867-70; PX 26). 36. -A glycerol/water cellulose pad is included in the Polysorb package. (Kaplan Tr. 813-15, 866-70). The pad is placed in the package to keep the glycerin level on the suture constant by filling the areas within the package that have no glycerin and thereby establishing an equilibrium of glycerin in the enclosed atmosphere. (Kaplan Tr. 814, 870-76, 881, 915-16 (“[T]he purpose of the pad is to fill all the spaces on all the surfaces, but not the suture.”)). 37. In developing U.S. Surgical’s synthetic absorbable suture, Dr. Kaplan sought to produce a suture that would be smoother and easier to handle in comparison to existing synthetic absorbable sutures. (Kaplan Tr. 759, 842). The handling characteristics of silk were used as a standard. (Kaplan Tr. 759-60, 842). With these goals in mind, he decided to use a unique braid structure (Kap-lan Tr. 750-51, 757-59; Wiles Tr. 1459) and glycerin as a plasticizer (Kaplan Tr. 759-60; Wiles Tr. 1415, 1459) without reference to the Glick ’622 patent. (Kaplan Tr. 779). 38. Dr. Kaplan decided to use glycerin as a plasticizer because it had been used with other medical products and was edible, non-reaetive with tissue, and emollient. (Kaplan Tr. 760). 39. Although glycerin is not a polymer, does not significantly enhance the tensile strength of the suture, and does not directly participate in the wound closure process, (Kaplan Tr. 817), its function as a plasticizer affects the flexibility of the suture. Poly-sorb’s promoted reduction in tissue drag, however, results from the terpolymer coating, not the glycerin. (Kaplan Tr. 839^11). 40. The glycerin, for unknown reasons, (Kaplan Tr. 791, 864-65; Schaefgen Tr. 1698-70 (hypothesis)), allows Polysorb to be packaged above the .25% maximum moisture level contained in the ’622 patent without causing the suture to degrade prematurely. (Kaplan Tr. 759-60, 778-79; Wiles Tr. 1397-1401). 41. In addition to promoting Polysorb’s reduced tissue drag (Kaplan Tr. 768) and improved handling characteristics, U.S. Surgical promotes improvements in the needle quality and packaging of its suture products. (Kaplan Tr. 747-50, 759-60, 776-77; Knarr Tr. 1766). 42. Two United States patents have issued to U.S. Surgical for Polysorb; one for the claimed improvement in storage stability achieved by the glycerin composition and the other for the braid structure. (Kaplan Tr. 792; DX V; DX W). II. VALIDITY A Obviousness-Type Double Patenting 43. U.S. Surgical asserts that the ’622 patent is invalid for obviousness-type double patenting and is therefore an unlawful extension of the now expired U.S. Patent No. 3,626,948 (the “ ’948 patent”). The ’948 patent issued on December 14,1971 and expired on December 14,1988. Cyanamid owns both the ’622 and the ’948 patents, and Arthur Glick is an inventor of both patents. (PX 1; PX 67). 44. In assessing an obviousness-type double patenting defense, the principal factual determination is whether, to one of ordinary skill, in the art, Claim 1 of the ’622 patent was an obvious modification of the claimed invention of the ’948 patent in light of the prior art. (Adelman Tr. 950-51; Chi-sum Tr. 1864-65). 45. The expired ’948 patent claims synthetic absorbable polyglycolie acid surgical prostheses, including sutures, that have enhanced in vivo strength retention. Claim 1 of the ’948 patent reads as follows: An absorbable surgical prosthesis which is compatible in living tissue comprising a filamentary strand structure of synthetic tissue absorbable material for use as a suture or ligature, said absorbable material consisting of polyglycolie acid, substantially free of vaporizable impurities, having substantially enhanced in vivo strength retention characteristics and being further characterized by a weight loss of less than 0.4 percent by weight when said polyglycolie acid is heated for 3 hours at 135 [degrees] C. under a pressure of 4 mm. of mercury. (PX 67, cols. 11-12). 46. Claim 1 of the ’948 patent requires the polyglycolie acid suture to be “substantially free of vaporizable impurities,” which include water. (PX 67, col. 2,1.58-col. 3,1.5; Tanquary Tr. 634, 638; Chisum Tr. 1866). 47. The heating and pressure conditions described in the ’948 patent for removing vaporizable impurities, (PX 67, col. 12,11.23-25), result in a suture that has a moisture content by weight of less than .1% (Kaplan Tr. 786-87, 789 (.03%-.05% range); Wiles Tr. 1427 (“bone dry”)). The moisture content of the suture claimed in the ’948 patent is therefore within the ’622 patent’s claim of “at or less than .25%” (PX 1, col. 21, 11.25-27). 48. Dr. Tanquary acknowledged that the ’948 patent describes “pretty rigorous conditions” for removing vaporizable impurities that will result in a polyglycolie acid suture having improved stability. (Tanquary Tr. 634, 638-39). Obtaining improved stability of a polyglycolie acid suture was also the goal of the ’622 patent. (PX 1, col. 3, 11.33-48). 49. The polyglycolie acid polymer in the ’948 and ’622 patents is the same. (Chi-sum Tr. 1868). 50. The polyglycolie acid suture in the claims of the ’948 and ’622 patents are both stable primarily because of the absence of, inter alia, moisture. (Tanquary Tr. 634, 638-39; Wiles Tr. 1377-78; PX 1; PX 67). 51. Hence, the only element of the ’622 patent claim not also contained in the language of the ’948 patent claim is the moisture impervious package. (Kaplan Tr. 906-07; • Chisum Tr. 1868, 1870). 52. Moisture impervious packages were known to persons skilled in the art before the ’622 patent application was filed. Drs. Tanquary and Wiles both worked with moisture impervious aluminum foil packages in the 1950’s and 1960’s. (Tanquary Tr. 658-60; Wiles Tr. 1427-31). The ’622 prosecution history reveals, moreover, that the moisture impervious packaging used and described by Gliek was known in the art. (Adelman Tr. 974-76; Chisum Tr. 1871; DX E (Brief on Appeal at 9); Pl.’s Post-Hearing Reply Br. at 2 n. 1). Compare (DX DJ, at 5) (“[T]he finding of a container impervious to water vapor was an engineering problem as recognized by the examiner.”) with (DX DJ, at 5) (“The package itself as here claimed is also novel.”). 53. Since moisture impervious packaging was known in the art and since the ’948 patent taught that removing (and preventing the recondensation of) substantially all of the moisture improved the stability of the poly-glycolic acid suture, it would have been prima facie obvious to a person of ordinary skill in the art to package the desiccated polyglycolic acid suture claimed by the ’948 patent in the known moisture impervious package in order to maintain its stability. (Kaplan Tr. 908-09, 922-23; Wiles Tr. 1428, 1502-03, 1507-10; Chisum Tr. 1869-72, 1875-77, 1934-35, 1937-38; PX 67, col. 3, 11.47-55). But see (Tan-quary Tr. 643; Adelman Tr. 954-55). Otherwise, it would have made no sense to treat the polyglycolic acid suture in accordance with the ’948 patent and remove the moisture in the first place. (Wiles Tr. 1428); see also (Adelman Tr. 976-78). Hence, the ’948 patent suggests to one skilled in the art that, in order to use (or even measure) the benefits of the invention, the suture claimed should be kept in a moisture free environment, i.e., moisture impervious packaging. 54. Cyanamid argues that, since the ’948 patent was cited in the specification of the ’622 patent, the Patent Office considered and rejected the obviousness-type double patenting issue. However, the ’948 patent was simply listed among six other patents in the specification, (PX 1, col. 2, 11.49-52; Chisum Tr. 1883-84), with no statement in the patent or the prosecution history that would have referred the Examiner to the ’948 patent’s disclosure of a “bone-dry” polygly-colic acid suture, which, based upon the evidence, would have a moisture content at or below .25% (Chisum Tr. 1884) (“There is no reference there or highlighting of 948 as disclosing the dryness factor or removing impurities, including water, which is quite different than the general disclosures that most of these patents have about glycolic acid sutures and surgical elements.”). In addition, the ’948 patent was not identified on the face of the ’622 patent under the “references cited” and was not therefore formally cited or “of record” in the ’622 patent proceedings. (Chisum Tr. 1881-83). 55. There is also no evidence to suggest that the Examiner actually considered the double patenting issue as it related to the ’948 patent or otherwise became aware that the ’948 patent claim contained the teaching that a suture processed under its conditions would fall within the ’622 patent’s limitation of at or less than .25% moisture and thereby improve the suture’s stability. (Chisum Tr. 1881-82). This information would have been important to the Examiner because the .25% limitation formed a principal basis for allowing the claims of the ’622 patent. (Adelman Tr. 942; Chisum Tr. 1872-77, 1883-85; DX DL). 56. Cyanamid’s response to U.S. Surgical’s showing of obviousness-type double patenting consists of an allegation that the ’948 patent specification is inconsistent with the claims of the ’622 patent. (Tanquary Tr. 634-37; Kaplan Tr. 907-08; Adelman Tr. 955; PX 1, col. 6, 11.38-48; PX 67, col. 8, 11.12 — 15). According to Cyanamid, the ’948 patent specification suggests, through a reference to U.S. Patent No. 3,297,033 (the “Schmitt ’033 patent”), the use of a moisture pervious package with its treated polyglycolic sutures. (PX 67, col. 8, 11.12-15; PX 72). Cyanamid’s reliance on this passage of the ’948 patent specification is unfounded. 57. First, the double patenting inquiry centers only upon the claims of the ’948 patent, (Chisum Tr. 1864-65; Adelman Tr. 951), and the claims of the ’948 patent do not refer to packaging. (Kaplan Tr. 906; Chi-sum Tr. 1926; PX 67). Although the specification may be considered to the extent necessary to interpret the claims, (Chisum Tr. 1864), Cyanamid has not provided a reason for considering the specification on this issue. 58. Second, the moisture pervious packaging referred to in the passage of the specification relied upon by Cyanamid is inconsistent with the teaching of the ’948 patent that vaporizable impurities such as water, once removed, must be kept away from the suture and its surrounding environment. Compare (Kaplan Tr. 909; PX 67, col. 3,11.47-70) with (Tanquary Tr. 638-39). A person skilled in the art would have understood this teaching to require moisture impervious packaging in order to prevent the removed moisture from redepositing itself on the suture and in order to maintain the stability of the desiccated suture. (Wiles Tr. 1428; Kaplan Tr. 909, 922-23). 59. Third, Cyanamid’s contention is inconsistent with Glick’s contemporaneous knowledge that a moisture impervious package was required. Glick knew at least as early as October 25,1968 (two months before the ’948 patent application was filed on December 23, 1968) that a moisture impervious package was required in order to maintain the stability of the “bone-dry” suture of the ’948 patent claims. (DX AY). Moreover, the ’622 patent’s disclosure of the inappropriateness of moisture pervious packaging, (Tanquary Tr. 636-37, 641; PX 1, col. 6, 11.38-48 & col. 9, 11.1-4), the application for which was filed ten days after the ’948 patent application, (PX 1 (Jan. 2,1969); Chisum Tr. 1878), and based upon an invention disclosure dated over two months earlier, evidences Glick’s knowledge at the time the ’948 patent application was filed that a moisture impervious package was necessary to maintain the stability of suture taught in the ’948 patent. Hence, in these circumstances, Glick’s reference in the ’948 patent “away” from the ’622 patent cannot later become an objective consideration of nonobviousness in the ’622 patent litigation. 60. Glick’s failure to disclose the necessity of moisture impervious packaging in the ’948 patent application raises the following questions: (i) whether he disclosed the best mode for practicing the invention, (Chi-sum Tr. 1932-33; 2001-03), (ii) whether, in light of his record of invention, he disclosed accurate information (i.e., the reference to packaging in accordance with the ’033 patent) to the Patent Office during the prosecution of the ’948 patent, and (iii) whether Glick therefore intended to extend the patent grant beyond the expiration of the ’948 patent. (Chisum Tr. 2001-03; DX AY). 61. Cyanamid’s arguments . are insufficient to rebut U.S. Surgical’s prima facie case that the Claim 1 of the ’622 patent is an obvious modification of Claim 1 of the ’948 patent. B. Prior Public Use 62. U.S. Surgical’s second invalidity defense is based upon its contention that Cyanamid’s polyglycolic acid sutures packaged in accordance with the ’622 patent were in public use more than one year before the effective filing date of the ’622 patent. 63. The effective filing date of the ’622 patent is the date of the first application in the series of applications that contains all of the elements of the ’622 patent claim. (Chi-sum Tr. 1885-89,1890-94,1997-98; Adelman Tr. 943-45). 64. The first ’622 patent application (S.N. 788,501), which was filed on January 2, 1969, does not literally disclose any numerical moisture limitations, including the .25% limitation of the ’622 patent claim. (Adelman Tr. 943; Chisum Tr. 1887-88,1891; DX D). The .25% limitation first appeared in the second ’622 patent application (S.N. 138,425), which was filed on April 29, 1971. (Chisum Tr. 1887-88; Adelman Tr. 943-45; Tanquary Tr. 2116-17; DX C, at 29, Table IV). 65. After filing the second application, Glick admitted that claims containing the .25% limitation were entitled only to the April 29,1971 filing date. (Chisum Tr. 1890-94, 1942-45; DX FV, at 5). In the same disclosure, Glick stated that claims containing much lower moisture limitations — below .05% — were inherently disclosed and supported by the preferred embodiment of the first ’622 patent application. (Chisum Tr. 1945-48, 1893, 1950-51). Glick therefore concluded that he could not find inherent support for the .25% limitation in the first application. (Chisum Tr. 1941-47; DX FV, at 5-6). But see (Adelman Tr. 983-84). 66. Although the first ’622 patent application does not literally disclose or support-the .25% limitation, (Adelman Tr. 948; Tanquary Tr. 2116; Chisum Tr. 1887-88, 1891), Cyan-amid, in response to the prima facie evidence of the effective filing date, contends that the .25% limitation is inherently disclosed in the first ’622 patent application. 67. As a person skilled in the art, Dr. Tanquary testified in rebuttal that, from the disclosure in the first ’622 patent application of sutures packaged at 20-30% relative humidity, (Tanquary Tr. 2108-12), he would have been able to determine the moisture content “break point” of .25% that would provide a useful suture. In order to make this ultimate determination, however, Dr. Tanquary testified that he would have had to perform experiments with moisture analyzers to take the measurements. (Tanquary Tr. 2114AL9; Adelman Tr. 946-47, 983). Based upon his testimony, however, there is no evidence to suggest that Dr. Tanquary would have considered those experiments if he did not have the second ’622 patent application to guide him. Dr. Tanquary'testified that the sutures in the first application packaged in the 20-30% relative humidity range were on the “ragged edge” of usefulness and that he could not be certain from the first application’s disclosure that any suture in this range would be useful after storage. (Tanquary Tr. 2114-16 (“And I really don’t know.”) (“Maybe as you get down toward 20 percent it’s going to be okay.”)). Hence, the first application’s disclosure would not have necessarily or inevitably led a person skilled in the art to the critical .25% limitation or to further inquiry or experiments into the usefulness of sutures in the 20-30% relative humidity range, which includes those having a moisture content of .25% by weight. 68. Dr. Tanquary’s testimony does not establish that the first ’622 patent application would necessarily or inevitably lead one skilled in the art to identify inherently the critical .25% limitation within the first application, which was first disclosed in the second, April 29, 1971 application. His ability, as one skilled in the art, to run a series of experiments to derive the critical limitation is insufficient to show that the limitation is described in the first application as a part of the invention later claimed. 69. Dr. Tanquary’s opinion also contradicts the earlier admission made by Glick that the .25% limitation was entitled only to the April 29, 1971 fifing date of the second application. (DX-FV, at 5). 70. The ’622 patent is entitled only to the filing date of the second ’622 patent application, April 29, 1971. 71. Because the effective filing date of the ’622 patent is April 29,1971, this Court considered evidence of public use prior to April 29, 1970. (Chisum Tr. 1885-89). 72. Numerous publications demonstrate that Cyanamid’s polyglycolic acid sutures were used in many surgical operations prior to April 29, 1970. (Chisum Tr. 1898-1904; DX CA; DX CB; DX CC; DX CD; DX CE; DX CF; DX CG). 73. The principal determination is therefore whether the polyglycolic acid sutures described in the publications were packaged in accordance with the ’622 patent. The publications describe surgical procedures that commenced at least as early as 1968 in which Cyanamid’s polyglycolic acid sutures, stored in dry packages, were used. (Chisum Tr. 1895-97; DX BA; DX CC). But see (Adelman Tr. 956-57). [[]] (Chisum Tr. 1894-95; DX AY). Finally, the invention disclosure states the “package is tentatively that which will be used to market the poly-glycolic acid suture,” (DX AY), which strongly suggests that the sutures used in the surgical procedures described in the publications were packaged in accordance with the ’622 patent. Hence, the dry packages used in the clinical trials described in the publications were undoubtedly moisture impervious, rather than those packages that were termed “dry” but only “free from visible moisture.” (Adelman Tr. 1015-16; DX DJ¿ at 3). 74. Cyanamid does not dispute the accuracy of the publications or that the sutures used in the surgical procedures were packaged in accordance with the ’622 patent. Rather, Cyanamid contends that any use of the ’622 patent package prior to April 29, 1970 was experimental, non-commercial, and investigatory. Cyanamid therefore contends that this experimentation (for the purpose of determining whether the sutures, however supplied, would work for their intended purposes (Adelman Tr. 959-60)) cannot constitute public use. The evidence, however, shows that the surgical procedures prior to April 29, 1970 were not experimental because: (i) [[]] (ii) the information collected during the surgical procedures did not relate to the invention, i.e., the suture package or storage stability; (iii) there is no evidence that Glick was involved in, had control over, or obtained feedback from the surgical procedures; and (iv) there is no evidence that the participants in the surgical procedures were placed under any limitation or obligation of confidentiality. Indeed, the results of the surgical procedures were published widely. (Chisum Tr. 1894-98, 1903-04; DX AY; DX BA; DX CA; DX CB; DX CD; DX CE; DX CF; DX CG). The breadth and scope of these publications, moreover, strongly suggests that the surgical procedures were designed commercially to promote the product in the surgical community. (Adelman Tr. 961, 994-95, 997-98). 75. The Court finds that U.S. Surgical has established a prima facie case that the package claimed in the ’622 patent was in public use prior to April 29, 1970. (Chisum Tr. 1903-04). Because any other evidence that relates to these surgical procedures and publications is within Cyanamid’s control, (Chisum Tr. 1904-05; Adelman Tr. 992), and because Cyanamid has not rebutted U.S. Surgical’s prima facie case of public use or supported its contention that the surgical procedures were experimental, the Court finds that any additional evidence under Cyanamid’s control would, at this stage in the proceeding, likely bolster U.S. Surgical’s defense. III. INFRINGEMENT A. Claim 1 of the ’622 Patent 76. Claim 1 of the ’622 patent reads as follows: A package comprising an air-tight sealed container fabricated from a material which is substantially impervious to water vapor, said container having therein a storage stable sterile synthetic surgical element of a polymer subject to hydrolytic degradation to non-toxic, tissue-compatible absorb-able components, said polymer having gly-colic acid ester linkages, said storage stable sterile synthetic surgical element further characterized in that the absorbed water moisture in the sterile surgical element is at or less than 0.25% by weight of the sterile surgical element, in the sterile enclosure. (PX 1, col. 21, 11.15-27; DX DP). 77. A suture is one of the surgical elements covered by the ’622 patent. (Tan-quary Tr. 654; Chisum Tr. 1954-55; PX 1, col. 21, 11.28-30; col. 5). 78. The “surgical element” described in the ’622 patent means the entire suture (in this case Polysorb), and this Court therefore interprets Claim 1 to mean that all of the moisture in the Polysorb suture is considered in determining infringement, not just moisture in the polymeric portion of the suture. Compare (Tanquary Tr. 548-49, 554-60, 655-57; Adelman Tr. 938-41, 969-71, 1000-02) with (Wiles Tr. 1422-25; Chisum Tr. 1908-11, 1979-80). 79. As so interpreted, Polysorb contains every element of Claim 1 of the ’622 patent except the moisture limitation of “at or less than 0.25% by weight of the sterile surgical element.” (Levy Tr. 186-88; Geoffroy Tr. 1327-29; PX 19; PX 29; DX Z; DX EB). 80. This Court’s interpretation of Claim 1 is based upon the language and structure of the claim, by the specification of the ’622 patent, by other patents cited in the ’622 patent, by the prosecution history of the ’622 patent, by the testimony of persons skilled in the art, and by Cyanamid’s conduct. 81. Claim 1 relates to a package containing a “surgical element of a polymer.” Cyanamid interprets this phrase to mean that the term “surgical element” as used elsewhere in the claim refers only to the polymer. (Tanquary Tr. 558-60). The claim, however, does not suggest that the phrase restricts the content of the surgical element to the polymer, which, although primary, is only one component of a surgical element. (Wiles Tr. 1422-25; Chisum Tr. 1908-11 (“There certainly wasn’t any dictated conclusion that the only thing you consider is the polymer in the surgical element or that the surgical element of a polymer has only the polymer in it and nothing else.”); PX 1, col. 21, 11.14-27). Professor Adelman based his interpretation of Claim 1 in large part upon the “incongruity” of U.S. Surgical’s interpretation of the claim. (Adelman Tr. 969-71). He was concerned that other “non-infringing” embodiments of Claim 1 would infringe under U.S. Surgical’s interpretation if, for example, a “heavy coating” or “stainless steel network” brought the total weight of the “surgical element” to a level where the “non-infringing water content” suddenly became at or less than 0.25% by weight. On the present record, however, the Court rejects this argument and instead focuses on the traditional tools of claim construction, discussed above and below, in part because “it’s always possible to think up some strange embodiment that might fall within a patent claim but not be operable.” (Chisum Tr. 1969); see also (Chisum Tr. 1979-80) (The claim discloses a practical, clear “measuring stick,” and “[mjaybe it doesn’t work perfectly for all types of surgical elements, but we have to have a practical measuring stick in a patent claim.”). 82. The language in the claim differentiates the surgical element and the polymer. (Chisum Tr. 1908-10). Athough the claim characterizes the polymer apart from the surgical element (“a polymer subject to hy-drolytic degradation” and “said polymer having glycolic acid ester linkages”), it defines the moisture limitation in terms of the surgical element rather than the polymer. (PX 1, col. 21, 11.14-27). Hence, the polymer and the surgical element have different meanings. But see (Tanquary Tr. 682) (“I look at [the polymer and the surgical element in Claim 1] as being identical, just describing them in different ways.”). 83. The ’622 patent specification states that the surgical element may contain components in addition to the polymer and therefore contemplates the measurement and consideration of the moisture content of all of the components of the suture. The specification nowhere states or suggests that, in order to fall within Claim 1, the surgical element or suture must be made only from a polymer or that the moisture content of other components of the surgical element should not be considered. 84. The ’622 patent specification states that the “polyglycolie acid suture itself may be in any form whatsoever such as a multifi-lament braid or monofilament. It may further be needled, dyed, coated, or otherwise treated in accordance with standard suture techniques.” (PX 1, col. 10, 11.45-49); (Chi-sum Tr. 1914). In addition, the ’622 patent specification states that the polymer may be combined with “other Components.” (PX 1, col. 5, 1.35). 85. The ’622 patent states that surgical elements may contain absorbable and nonab-sorbable components, such- as those described in U.S. Patent No. 3,463,158. (PX 1, col. 15, 11.48-59). 86. The moisture tests described in the ’622 patent can determine only the moisture content of the entire suture, and the ’622 patent does not teach a test for measuring the separate moisture content of the components of the suture. (Levy Tr. 216-17; Lon-gordo Tr. 249, 474-80; Tanquary Tr. 696-97; Chisum Tr. 1913; Geoffroy Tr. 1310-13, 1321, 1331; Kaplan Tr. 921; DX DS (Excerpts Re: Moisture Test Procedures From U.S. Patent 4,135,622 (quoting col. 16, 11.29-34, 38-53)). 87. The ’622 patent teaches that it is “essential” to maintain the sutures in a desiccated state and contains admonitions that water cannot be permitted to contact the polymer or even to be present in the package environment. (Schaefgen Tr. 1517-20; PX 1, col. 3, 11.34-41; col. 6, 11.21-31, 11.49-64; col. 13, I.64-col. 14, 1.20; col. 18, 11.50-53; col. 20, II.47-49). Since, to the inventor, it was necessary to remove all moisture within the suture and in the environment to achieve the desired results, the claim limitation of .25% applies to all of the moisture in the suture. (Chisum Tr. 1983-84). 88. The ’622 patent incorporates by reference the Schmitt ’033 patent, which describes surgical elements that include plasticizers, coatings, and dyes. (PX 1, col. 1, 11.22-24; PX 72, col. 3, 11.42-52). Hence, the ’622 patent’s surgical element could contain non-polymeric components. 89. The ’622 patent specification, which contemplates that plasticizers may form one of the components of the surgical element, is significant because the glycerin in Polysorb functions as a plasticizer and diffuses into the polymer. (Kaplan Tr. 759-60, 810-11, 860, 863-65; Wiles Tr. 1384, 1391, 1393-94, 1437, 1455-60, 1475; Tanquary Tr. 582-83, 598-99 (glycerin is negligible)). In a series of hypothetical questions, Professor Adelman acknowledged that any plasticizing component within (i.e., bonded to) the polymer is considered part of the surgical element for the purpose of determining moisture content. (Adelman Tr. 1013-14). 90. The ’622 patent specification is consistent with U.S. Surgical’s interpretation of the claim. 91. During the prosecution history of the ’622 patent, the pending claims characterized the moisture content in terms of the polyglycolic acid. These claims were later amended to characterize the moisture content in terms of the surgical element instead of the polyglycolic acid, which shows that Gliek both appreciated the difference and chose different language depending upon the meaning he intended to convey. (Chisum Tr. 1915-16, 1951-54; DX DE, at 33; DX DG, at 41; DX DI, at 2); see also (Tanquary Tr. 691-94, 715-19). 92. As in the patent specification, the prosecution history contains several teachings that mandate the complete removal of moisture not only from the suture but also from its as packaged environment. (Chisum Tr. 1916-19). For instance, Dr. McPherson submitted a critical affidavit that reads in part as- follows: To secure the advantages of the present invention, three things must be achieved. One must vigorously remove absorbed moisture vapor from the suture material and container interior. One must maintain the container interior and its contents in this desiccated state before sealing the container. Finally, one must hermetically seal the moisture vapor impermeable container. I cannot over stress that all of the above three conditions must be met and, for example, it is not enough just to remove absorbed moisture vapor from the suture but not take care to preserve the desiccated state prior to sealing the suture in the moisture vapor impermeable container.... (DX DK, at 8). 93. Cyanamid’s current interpretation of the claim, which allows significant amounts of moisture in the suture package and in the suture itself, contradicts the prosecution history of the ’622 patent. (Schaefgen Tr. 1520). Dr. Tanquary concurred in part when he said that glycerin containing water as a component of a synthetic absorbable suture could not have been contemplated by Gliek at the time of the ’622 patent proceedings. (Tanquary Tr. 706-10). 94. The testimony of persons skilled in the art of polymer science, suture technology, and testing technology supports this Court’s interpretation of the claim. 95. Dr. Wiles testified that glycerin is part of the suture and that a surgical element is the entire suture product as it comes out of the package, including the glycerin. (Wiles Tr. 1422-25). 96. Dr. Kaplan testified that glycerin is part of the suture and that the surgical element is the entire suture. (Kaplan Tr; 810-11, 860, 863-65, 920 (“[W]e have done the exact opposite of what Gliek said, which is to add water to make something soft, rather than take it away.”)). As such, Dr. Kaplan never tested (nor considered testing) the individual components of Polysorb under the ’622 patent. (Kaplan Tr. 779-80). 97. Dr. Tanquary testified that, in general, a suture is a surgical element in common everyday terms, but that, as one skilled in the art of polyglycolic add sutures, the surgical element is the polymer. (Tanquary Tr. 654-57, 688-90, 701-02, 721-22, 650-713); see (Tanquary Tr. 688) (“At the time [the claim] was written, I’m sure that that’s what was meant at that point [because w]e were referring to the polyhydroxacetic ester suture which is the only thing in there.”)- Dr. Tan-quary also contended that, if “surgical element” means the entire suture or the “thing that comes out of the package,” the Court should include not only the coating but also the needle. He contended correctly that including the needle would make no sense because it would skew the moisture content downward unnecessarily. (Tanquary Tr. 684-88). However, under this Court’s interpretation of the claim, coupling the incongruity of measuring the needle with measuring the other components of Polysorb is not persuasive. Everyone agrees that the needle should not be included, (Wiles Tr. 1423, 1494-95) (“The needle is a common factor in a surgical device like a suture regardless of what’s fastened on the end of it.”); (Chisum Tr. 1913, 1963-64), but this does not mean that additional components within the suture, which are expressly contemplated by the ’622 patent, should also not be included. 98. The ’622 patent neither describes (nor provides a reason for) a test that could determine the moisture content of the individual suture components. Moreover, the testimony adduced at the hearing concluded that no test or technique had ever been published, known to persons skilled in the art, or even attempted before Drs. Levy and Longordo to determine the moisture content of the individual components of a suture. (Levy Tr. 216-18; Longordo Tr. 249, 475; Tanquary Tr. 696-97; Kaplan Tr. 779-81, 915; Geof-froy Tr. 1331; Schaefgen Tr. 1522-23, 1526-27). 99. Prior to and during this action, Cyan-amid tested sutures in accordance with the ’622 patent and therefore considered all of the moisture in the suture for the purpose of determining infringement under Claim 1. 100. Upon receipt of Polysorb samples, Cyanamid tested the entire suture in accordance with the ’622 patent, (Longordo Tr. 247, 250-51, 356-57, 362-72, 375, 474), and compiled an average total moisture content of .69%, (Levy Tr. 187-88), which is both consistent with U.S. Surgical’s moisture testing and above the .25% limitation in Claim 1. (Geoffroy Tr. 1327-31; DX EB). With knowledge that Polysorb contained glycerin, (Longordo Tr. 246-53; DX Z), Cyanamid tested the total moisture content of the Poly-sorb suture for almost two months, (Longor-do Tr. 246-53; DX Z), and even used the same testing laboratory that U.S. Surgical used for its testing of Polysorb. (Longordo Tr. 363-68; Geoffroy Tr. 1329-31; DX AC). 101. Cyanamid tested the entire Polysorb suture because its protocol and the patent itself called for that method. (DX AJ) (confidential); (PX 1, col. 16, 11.29-34, 42-53). Every moisture test conducted by Cyanamid or any of its experts over the past twenty years has determined the total moisture content of the suture, including Cyanamid’s testing of competitive coated sutures for infringement under the ’622 patent. (DX AK; DX AM; DX AN; DX AP, at 1-2 [¶] ]] Thus, Cyanamid’s current interpretation of the claim is contrary to its original and long held interpretation. 102. The Polysorb suture contains over .25% moisture. (Levy Tr. 186-88; Geoffroy Tr. 1321-25 (.695% average); PX 19; PX 29; DX Z; DX EB). B. Cyanamid Testing of Polysorb 103. Although this Court does not agree with Cyanamid’s interpretation of Claim 1 of the ’622 patent, Cyanamid’s testing of Poly-sorb will nonetheless be evaluated. 104. Cyanamid’s failure to find infringement by testing for the moisture of the Poly-sorb suture as a whole led it to search for a testing technique that might determine the moisture associated with the components of Polysorb. (Levy Tr. 212-18; Longordo Tr. 364-66; DX AC). Dr. Levy was ultimately retained for that purpose. 105. Initially Dr. Levy was unsure whether such a test could be performed but he ultimately established a protocol that he believed would determine the moisture content only of the polymer component. (Levy Tr. 218). 106. In his protocol, Dr. Levy continued to test for, and determine, the moisture content of the suture as a whole but interpreted the results of the tests in a way that purports to distinguish between moisture derived from the glycerin and moisture derived from the polymer component of Polysorb. (Levy Tr. 117; Longordo Tr. 309-11). 107. The Kail Fischer test apparatus employed by Dr. Levy cannot itself distinguish between water associated with the polymer and water associated with the glycerin. (Levy Tr. 199; Longordo Tr. 300-01; Wiles Tr. 1405-06; Schaefgen Tr. 1528-29, 1534-35). To arrive at their ultimate conclusions, however, Drs. Levy and Longordo interpreted the total moisture data obtained over time from the Polysorb sutures through slopes drawn on logarithmic plots of the titration data. (Levy Tr. 118-20); see, e.g., (PX 33). 108. Cyanamid performed its analysis of Polysorb in a “glove box” or “dry box” that maintained its own internal environmental controls. (Longordo Tr. 259-60). 109. A controlled environment of 16% relative humidity was used to prevent the gain or loss of water moisture from the samples. (Longordo Tr. 274-75). 110. Inside the glove box, Dr. Longordo used rubber gloves to manipulate the instrumentation. An aluminum pan containing glass wool covered with a glycerol/water solution rested in the box to control the relative humidity. The glove box also contained a Sartorius balance and a microbalance capable of weighing in micrograms. Drs. Levy and Longordo performed the entire experiment, including the weighing of the suture and pad samples and the titration of the moisture in the suture, within the confines of the glove box. (Longordo Tr. 260-63, 271-74). 111. The environment in the glove box had a slightly higher relative humidity than the sealed package of the Polysorb suture product so that, upon removal from the package, the suture would not lose moisture. (Longordo Tr. 273-74). 112. The Polysorb sutures did not lose water moisture from the time they were opened until the time they were titrated, but they may have gained some moisture. (Lon-gordo Tr. 275-76). 113. Glycerol is completely miscible with water and has solubility characteristics similar to those of water. (Levy Tr. 86; Longor-do Tr. 285; PX 27). 114. The Aquatest 8 titrator is a sealed titration vessel which contains a volume of liquid Karl Fischer reagent that is kept in a swirling motion by a spinning magnetic stirrer bar, "with entry openings in the cover of the vessel for introducing a liquid or solid sample through an entry port. (Levy Tr. 58-61; Longordo Tr. 381-83; PX 55). 115. The Karl Fischer reagent is a substance that may be used when determining water in glycerol. (Levy Tr. 87). 116. The Aquatest 8 machine can detect moisture in microgram quantities. (Levy Tr. 40). 117. The Polysorb samples were analyzed using an Aquatest 8 moisture analyzer manufactured by Photovolt. (Longordo Tr. 252-53). 118. The Karl Fischer reagent is hygroscopic. (Longordo Tr. 232). 119. The Karl Fischer reagent is more hygroscopic than glycerol. (Longordo Tr. 233). 120. Glycerin, water, and a 95%/5% glyee-rin/water mixture are soluble in Karl Fischer reagent. (Levy Tr. 86-88; Longordo Tr. 293-96). But see (Wiles Tr. 1411) (“That’s true [but fit’s also irrelevant.”). 121. Karl Fischer reagent does not react with glycerin. (Levy Tr. 110-11). 122. In the Karl Fischer titrator, the reagent penetrates the structure of the suture and neutralizes whatever water it finds until all of the water is extracted. (Levy Tr. 92, 102-03, 107-08). 123. The polymer in Polysorb is not soluble in Karl Fischer reagent. (Levy Tr. 92). 124. Drs. Levy and Longordo conducted Karl Fischer titration extractions on seven Polysorb samples. (Levy Tr. 117-18). 125. After gathering titration data for the Polysorb suture, Drs. Levy and Longordo entered