PAUL L. FRIEDMAN, United States District Judge.
Dome Patent L.P. owns United States Patent No. 4,306,042 (the "Neefe Patent"), which was issued on December 15, 1981. The Neefe Patent is entitled "Method of Making a Contact Lens Material With Increased Oxygen Permeability," and it is based on an application filed by Russell A. Neefe. See JTX-1. In 2007, the United States Patent and Trademark Office (the "PTO") found that claim 1 of the Neefe Patent should be cancelled as obvious in light of the prior art. Dome timely filed a civil complaint under 35 U.S.C. §§ 145 and 306, requesting that this Court set aside the PTO's decision. See Compl. ¶ 20. After considering the parties' arguments, the administrative record, the decision of the PTO's Board of Patent Appeals and Interferences, the evidence presented during a three-day bench trial, and the relevant legal authorities, the Court concludes that the process recited in claim 1 of the Neefe Patent is unpatentable, as it would have been obvious to a person of ordinary skill in the art at the time the patent application was filed. The Court therefore will enter judgment in favor of the defendant, Teresa Stanek Rea ("the Director"), Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the PTO.
The Neefe Patent contains four claims, the first of which is relevant to this action. Claim 1 recites:
JTX-1 at col.5 lines 38-64 (emphasis added); id., Certificate of Correction. Steps (a) through (e) of this claim recite a process for manufacturing a chemical compound commonly known as "Tris." Step (f) describes a process for synthesizing Tris with three other compounds to create a rigid, gas permeable material suitable for manufacturing a contact lens.
In December 1997, Dome sought to enforce the Neefe Patent in an infringement action against several defendants. See Dome Patent L.P. v. Permeable Technologies, Inc., et al., Civil Action No. 98-6247 (filed in the Western District of New York, after being transferred from the Eastern District of California). One of these defendants, Optical Polymer Research, Inc., filed a request with the PTO for reexamination of the Neefe Patent. JTX-34 at 53-95 (Request for Reexamination, Aug. 27, 1998). On May 23, 2002, an examiner at the PTO concluded that claims 2, 3, and 4 of the Neefe Patent should be confirmed, but that claim 1 of the Neefe Patent—recited above—should be cancelled because the method it described "would have been obvious at the time the invention was made to a person having ordinary skill in the art." 35 U.S.C. § 103(a); JTX-34 at 1110-20 (Office Action in Ex Parte Reexamination).
On September 24, 2007, Dome timely filed this civil action pursuant to 35 U.S.C. §§ 145 and 306 for review of the Board's decision. Compl.; Jt. Pretrial Stmt. at 3. The Court conducted a three-day bench trial from January 28 through January 30, 2013, during which the parties introduced the expert testimony of Timothy E. Long, Ph.D., Mark A. Melamed, M.D., and William J. Benjamin, O.D., Ph.D., as well as testimony from the patent's author, Robert A. Neefe. Dr. Long, called as a witness by Dome, is a professor of chemistry at the Virginia Polytechnic Institute and State University and an expert in the field of polymer chemistry. Dr. Melamed, also Dome's witness, is an ophthalmologist with a large private practice in which he spends a substantial part of his time prescribing and fitting contact lenses. He also is a Professor of Ophthalmology at New York University School of Medicine. Dr. Melamed is an expert on the use and prescription of rigid gas permeable contact lenses and on the medical benefits of contact lenses with improved oxygen permeability.
As discussed in the Findings of Fact below, many of the relevant facts in this case are undisputed. The parties agree that a usable hard contact lens must be clear, rigid, oxygen permeable, and wettable (i.e., hydro philic). The parties also agree that the field of contact lens development witnessed a breakthrough in the 1970's with the advent of rigid gas permeable lenses, which combined the clarity, rigidity, and wettability of one prior technology (PMMA lenses) with the oxygen permeability of another prior technology (soft silicone lenses). One of the lead inventors in this field, Norman Gaylord in New Providence, New Jersey, created the first commercially viable rigid gas permeable lens material using a novel "polymer," composed of different "monomers." In
A few years later, a group of scientists led by Kyoichi Tanaka in Japan patented a different rigid gas permeable contact lens material using a non-Tris monomer with a range of cross-linking agents. One of Tanaka's preferred cross-linkers was a hydrophobic multifunctional siloxanyl alkyl ester, which is similar in molecular structure to the Tris monomer.
Less than two years later, Robert Neefe of Big Spring, Texas, combined the monomers used by Gaylord with the cross-linker used by Tanaka to develop a usable rigid gas permeable lens. Neefe's process was patented as claim 1 of U.S. Patent No. 4,306,042, recited above and referred to here as the Neefe Patent.
This case centers on the parties' disagreement as to whether it would have occurred to a person of ordinary skill in the art to do what Neefe did: to combine the first three compounds listed in step (f) of claim 1 of the Neefe Patent—i.e., Gaylord's compounds—with the fourth compound listed in step (f)—i.e., Tanaka's cross-linker. Dome contends that it would not have occurred to a person of ordinary skill to attempt this combination. According to Dome, one with ordinary skill would have been deterred from using both the Tris monomer from Gaylord and the Tris-type cross-linker from Tanaka in the same formulation, out of concern that the resulting compound would be unwettable or otherwise unusable for contact lens production. See Dome's Trial Brief at 10 ("[U]sing both a hydrophobic Tris monomer and a hydrophobic cross-linker would have been expected to yield a hydrophobic polymer that would be unsuitable as a contact lens material."); id. at 9 ("Neefe offered a novel and counter-intuitive solution to the oxygen permeability problem: a polymer that contains both a hydrophobic Tris monomer
The Director disagrees, arguing that it was established that the hydrophobicity of both the Tris monomer and the Tris-type cross-linker could be offset by the hydrophilic monomers suggested by Gaylord, particularly within the broad ranges identified by Neefe. See Director's Trial Brief at 28 ("Any concern about wettability arising from the use of a small amount of Tris (as low as 5% by weight), therefore, easily could be alleviated by use of a wetting agent (up to 90% by weight), while still remaining within the scope of the claim."). And while the Director does not dispute that the contact lens referenced by Dome was commercially successful, she argues that this success cannot be attributed to the Neefe process for several reasons, and therefore any evidence of success is irrelevant
The following findings of fact are based on the evidence submitted by the parties during the bench trial, the administrative record before the Board, the Board's opinion, the parties' stipulations of undisputed facts, and the record as a whole.
1. Claim 1 of the Neefe Patent recites a process for making material for the manufacture of a rigid gas permeable ("RGP") contact lens. JTX-1 at [57] (Abstract).
2. A material for use in a RGP contact lens should have the following four characteristics: it should be optically clear; it should be hard and rigid; it should be wettable; and it should be oxygen permeable. Jan. 28 AM Tr. at 49:8-50:13 (Long); Jan. 29 AM Tr. at 14:25-16:7, 17:2-21, 100:9-11 (Melamed); Jan. 29 PM Tr. at 48:3-11 (Benjamin).
3. Optical clarity is important in order for the material to provide a clear visual image for the user. See Jan. 28 AM Tr. at 49:8-10 (Long); Jan. 29 PM Tr. at 48:3-7 (Benjamin).
4. Rigidity is required so that the lens can be machineable into a precise enough shape to provide crisp, consistent visual acuity. Jan. 28 AM Tr. at 49:16-21 (Long); Jan. 29 PM Tr. at 48:3, 48:7-11 (Benjamin).
5. Wettability, which is the interaction of water with a surface (such as the surface of a contact lens), is necessary for a contact lens to be comfortable on the eye of the wearer. Jan. 28 AM Tr. at 50:7-13 (Long); Jan. 29 AM Tr. at 15:12-16:7, 17:7-9 (Melamed).
6. Wettability is important because contact lenses do not actually sit on the surface of the cornea of the eye; instead, they float on a thin film of tears on the surface of the cornea. Jan. 29 AM Tr. at 14:12-14 & 15:19-23 (Melamed). Contact lenses must be tolerated in the eye without eliciting a painful foreign body sensation, so an even coating of tears must be spread across the surface of the lens. Id. at 15:12-16:3 (Melamed).
7. A hydro phobic polymer is one that is water repellent, while a hydro philic polymer can readily absorb water. Jan. 28 AM Tr. at 10:2 (Long); Jan. 30 AM Tr. at 13:25 (Benjamin).
8. Adequate oxygen permeability is necessary to prevent long-term damage to the eye of the wearer. Jan. 28 AM Tr. at 49:22-50:6 (Long); Jan. 29 AM Tr. at 14:25-15:11, 17:2-6, 17:19-21, 100:9-11 (Melamed).
9. Oxygen permeability is important because a constant flow of oxygen to the cornea is essential to avoid degenerative changes in its cells. Jan. 29 AM Tr. at 14:25-15:11 (Melamed). The cornea has no blood supply to bring it oxygen, so it gets its oxygen from the atmosphere, through the open lids of the eye. Jan. 29 AM Tr. at 14:14-17 (Melamed).
10. Anything that covers the cornea—either a contact lens or the eyelid—impedes the flow of oxygen to the cornea. Jan. 29 AM Tr. at 14:17-20 (Melamed). Thus, the oxygen flow to the cornea is impeded during sleep. Id. at 16:10-21 (Melamed).
11. Even with a contact lens in place, oxygen can reach the front surface of the cornea in two ways: (1) it can permeate through the body of the contact lens itself; or (2) it can be carried by tears around the
12. The oxygen permeability of a material is measured in Dk, or "barrers." JTX-4 at 62; Jan. 29 AM Tr. at 25:22-23 (Melamed); Jan. 30 AM Tr. at 35:25 (Benjamin).
13. Ideally, a contact lens material will meet all four criteria: clarity, hardness, oxygen permeability, and wettability. Jan. 28 AM Tr. at 53:21-24 (Long). As Dome's counsel noted at trial, these criteria can be remembered with the acronym "CHOW." Jan. 28 AM Tr. at 9:7-8; see also Jan. 28 AM Tr. at 48:16-17 (Long).
14. The technology at issue in this case is the polymer chemistry required to manufacture RGP contact lenses.
15. A RGP contact lens is made from material that permits the passage of oxygen through the lens to the eye of the wearer. Jan. 29 AM Tr. at 40:9-10 (Melamed); JTX-4 at 63.
16. A "polymer," also known as a "macromolecule," is a large molecule made up of many smaller units called "monomers." JTX-3 at 3.
17. The process of synthesizing a polymer from monomers is called "polymerization." JTX-3 at 3.
18. A "copolymer" is a type of polymer that is formed from two or more different types of monomers. JTX-3 at 7.
19. The process of synthesizing a copolymer is known as "copolymerization." PTX-4, at tab 2; Director's PFF. 14.
20. Polymers can take different forms, including linear, branched, and cross-linked (i.e., networked). JTX-3 at 8-10. Illustrative examples of these different forms were provided at trial and are reproduced below. See PTX-4 at Tab 3; Jan. 28 AM Tr. at 57:10-63:20 (Long).
• Different three-dimensional structures of copolymers
21. The materials that make up a polymer can alter the polymer's chemical structure and therefore its physical properties. Jan. 28 AM Tr. at 63:1-20 (Long).
22. For example, the use of one cross-linking agent instead of another can affect the size of the gaps in the polymer's structure, which can affect the polymer's oxygen permeability. Jan. 28 AM Tr. at 62:3-63:20 (Long).
23. Cross-linked polymers can be exceptionally complex; the cross-linking agents may be close together or far apart, short or long, few or plentiful. Jan. 28 AM Tr. at 61:8-22 (Long).
This case centers on a dispute about whether Neefe's invention would have been obvious to a person of ordinary skill in the art, in light of the technology existing and known in the field at the time of Neefe's invention—i.e., the prior art. Although the facts discussed in the section below are undisputed, the Court makes the following findings relating to the prior art and the Neefe Patent, with the purpose of providing background and context.
24. The first practical plastic contact lens was made out of polymethyl methacrylate ("PMMA"), which was first branded commercially as Plexiglas. See Jan. 28 AM Tr. at 50:25-51:1 (Long); Jan. 30 AM Tr. at 12:2-18 (Benjamin).
25. PMMA is a rigid, glass-like thermoplastic with relatively little flexibility. Jan. 28 AM Tr. at 51:9-10 (Long), 70:17-18; JTX-4 at 61-62.
26. PMMA is highly wettable, but it also is completely impermeable to oxygen. See Jan. 28 AM Tr. at 51:13-21 (Long); Jan. 30 AM Tr. at 12:2-18 (Benjamin).
27. This lack of oxygen permeability of PMMA lenses led to the development of so-called "contact lens over-wear syndrome" in users. Wearing these lenses for an extended period of time could cause pain, death of nerve endings in the cornea, blurred or filmy vision, glare, and halos around lights. Jan. 29 AM Tr. at 15:2-9 (Melamed); see also JTX-10 at col.1 lines 28-32; Jan. 30 AM Tr. at 16:10-21 (Benjamin); JTX-27 at 279.
28. In response to the problem of contact lens over-wear, many scientists began exploring polymers containing siloxanes for use in contact lens materials. Jan. 28 AM Tr. at 51:22-53:24 (Long); JTX-4 at 7, 60-63.
29. Siloxanes are chemical compounds containing carbon atoms (C), oxygen atoms (O), and silicon atoms (Si), in which two silicon atoms are bonded directly to one oxygen atom in the form -Si-O-Si-. JTX-4 at 60-62. The -Si-O-Si- chain can be thought of as the polymer's backbone, to which other atoms and molecules are attached. Id.
PTX-4 at tab 8.
30. Siloxanes are highly oxygen permeable. They also, however, are hydrophobic—that is, water repellant. In addition, siloxanes are soft and difficult to machine. Jan. 28 AM Tr. at 52:10-25 (Long); Jan.
31. A significant breakthrough in the field of contact lens materials took place in the 1970's, when Norman G. Gaylord had the idea of using a rigid material for a contact lens that still allowed oxygen to pass through the lens to reach the cornea of the eye. Gaylord introduced the first RGP lens, an oxygen permeable contact lens made from a mixture of PMMA and silicone (siloxane). JTX-4 at 17; Jan. 29 AM Tr. at 22:24-25 (Melamed); id. at 53:19-24 (Melamed); see JTX-7; JTX-8.
32. In his invention, Gaylord combined four ingredients: (i) a silicone-based monomer; (ii) an acrylate; (iii) a wetting agent; and (iv) a cross-linking agent. Jan. 28 AM Tr. at 70:18-23 (Long); JTX-4 at 64; JTX-7 at col.1 lines 57-60; JTX-8 at col.1 lines 52-56, col.5 lines 39-46, col.6 lines 3-12; see Board Decision, JTX-16 at F.10.
33. In Gaylord's polymer, the silicone is the chemical compound 1,1,1-tris(trimethylsiloxy)methacryloxypropylsilane, which is commonly known in the contact lens field as a "Tris" monomer. Jan. 28 AM Tr. at 69:11-70:5 (Long); JTX-1 at col.3 lines 13-14; JTX-4 at 63; JTX-7 at col.2 lines 26-35; JTX-8 at col.2 lines 32-44.
34. After Gaylord, the Tris monomer became the "industry standard" siloxy-methacrylate monomer in the field of RGP contact lenses. JTX-4 at 63.
35. Tris is a siloxanyl alkyl ester compound. Jan. 28 PM Tr. at 66:8 (Long); JTX-1 at col.3 lines 12-14, col.5 lines 40-41.
36. Tris is very hydrophobic, i.e., water repellant. Jan. 28 AM Tr. at 66:2-4, 74:20-21 (Long); JTX-6 at col.1 lines 63-66.
37. In addition to Tris, Gaylord used methyl methacrylate ("MMA," the monomer in PMMA) as the acrylate, and he employed methacrylic acid as the wetting agent. Both MMA and methacrylic acid are hydrophilic: these comonomers therefore increased the wettability of the polymer. Jan. 28 AM Tr. at 67:3-12 (Long); Jan. 28 PM Tr. at 68:14-21 (Long); JTX-7 at col.3 line 29, col.4 lines 50-59; JTX-8 at col.3 line 65, col.5 lines 39-48; see also JTX-4 at 17.
38. The fourth ingredient, which Gaylord used to bind these comonomers together, was a hydrophilic, non-siloxane based cross-linking agent, such as ethylene glycol dimethacrylate. Jan. 28 AM Tr. at 70:9-13 (Long); PTX-4 at Tab 9.
39. Contact lenses manufactured using the Gaylord polymer were introduced into the marketplace in the late 1970's by Syntex, Inc. under the trade name Polycon. Jan. 30 AM Tr. at 40:2-7 (Benjamin); JTX-4 at 17; JTX-10 at col.2 lines 29-32; JTX-12 at 238.
40. The first Polycon lens (Polycon I) had an oxygen permeability of approximately 5 Dk; the second (Polycon II), an oxygen permeability of approximately 10 to 12 Dk. The Polycon lenses thus exhibited much better oxygen permeability than PMMA lenses, which were completely impermeable. JTX-4 at 67; JTX-12 at 238; JTX-27 at 273.
41. Gaylord explains that the reason for the increased oxygen permeability of his lens materials is the inclusion of silicone (i.e., the use of the siloxanyl alkyl ester), which "is highly permeable to oxygen."
42. At noted at FF. 30 and 36, although the presence of silicone improves the oxygen permeability of a contact lens material, it detracts from its wettability.
43. Gaylord addresses the issue of wettability in his patent. He states that "[w]hile some of the copolymers [disclosed in his patent] are inherently wettable by human tears, it may be necessary to improve the wettability of others." JTX-8 at col.5 lines 39-41.
44. Gaylord discloses four alternate methods for improving the wettability of these copolymers, including adding hydrophilic monomers to the copolymerization mixture and applying wetting agents to the surface of the contact lenses. JTX-8 at col.5 lines 42-58.
45. Although Gaylord's invention represented a significant improvement in oxygen permeability, the first lenses incorporating Gaylord's polymer still could not be used for prolonged daily wear. See Jan. 29 AM Tr. at 91:13-92:8 (Melamed).
46. After Gaylord's technique was known, several scientists worked to increase the oxygen permeability, wettability, and hardness of Gaylord's formulation. See Jan. 28 AM Tr. at 73:10-79:10 (Long); see, e.g., JTX-9 at col.1 lines 11-41.
47. One pair of scientists—Edward J. Ellis and Joseph C. Salamone at Polymer Technology Corporation in Massachusetts—improved Gaylord's technique by employing Tris but also adding an additional hydrophilic comonomer to improve the material's wettability and structural integrity. Jan. 28 AM Tr. at 73:20-74:21 (Long); see generally JTX-9. Ellis applied for a patent based on this invention on February 15, 1978. JTX-9 at [22].
48. The Ellis patent was issued on May 1, 1979. It was later used to create the Boston II lens, which had an oxygen permeability of approximately 12 to 14 Dk. JTX-9 at [45]; Jan. 29 AM Tr. at 25:22-25, 54:4-9 (Melamed); Jan. 30 AM Tr. at 69:25-70:2, 75:21-25 (Benjamin); JTX-4 at 66; JTX-12 at 238; JTX-21 at BL8556; JTX-27 at 273.
49. Another scientist, Nick N. Novicky of Wheeling, Illinois, attempted to solve the problems of the Gaylord polymers by replacing the Tris monomer with novel silicones of his own design. Jan. 28 AM Tr. at 75:23-25 (Long); see JTX-11 at col.3 lines 22-23, col.14 lines 37-45, col.18 lines 8-13.
50. Like Tris, the novel monomer employed by Novicky contains a methacrylate component and a tris(trimethylsiloxy) component. Jan. 28 AM Tr. at 76:22-77:9 (Long); JTX-11 at col.3 lines 49-53, col.3 lines 64-67, col.4 lines 25-39 (general formula), col.18 lines 28-39 (formula in claim 1).
51. Unlike Tris, the Novicky monomer contains an additional siloxane unit. JTX-11 at col.4 lines 25-39, col.18 lines 28-39; Jan. 28 AM Tr. at 76:1-4, 77:7-9 (Long).
52. This additional siloxane unit makes the novel Novicky monomer even more hydrophobic than Tris. Jan. 28 AM Tr. at 75:22-76:12 (Long).
53. In addition to the novel monomer, Novicky's polymer also contains hydrophilic wetting agents and hydrophilic MMA. JTX-11 at col.3 lines 44-48, col.6 line 65, col.7 line 27, col.18 lines 66-68, col.19 lines 1-3.
54. The Novicky polymer uses the same type of hydrophilic cross-linker used by Gaylord and Ellis; as noted supra at FF. 38, this cross-linker does not contain a siloxane group. JTX-11 at col.7 lines 15-24; Jan. 28 AM Tr. at 77:12-18 (Long).
56. RGP contact lenses incorporating the Novicky polymer reportedly were marketed by Fused Contacts as the Sil-O2-Flex lens. JTX-10 at col.8 line 23, col.8 line 38; JTX-12 at 238.
57. The Sil-O2-Flex lens had an oxygen permeability level of approximately 5 to 8 Dk. JTX-10 at col.8 line 38; JTX-12 at 238.
58. On September 22, 1978, a group of scientists led by Kyoichi Tanaka in Japan applied for a patent based on a novel polymer to be used for making an RGP contact lens. JTX-13 at [57].
59. Tanaka discloses that his copolymers have an excellent oxygen permeability and a good hydrophilic property (i.e., they are wettable). Jan. 28 PM Tr. at 79:17-19 (Long).
60. Tanaka departed from Gaylord (and Ellis) in two ways. First, rather than using the Tris monomer, Tanaka employed a novel non-Tris silicone monomer containing siloxanylalkyl ester groups, which are hydrophobic, and internal glycerol or polyether groups, which are hydrophilic. Tanaka's novel monomer thus was "amphiphilic," and had a higher affinity for water—i.e., was less water repellant—than the Tris monomer used by Gaylord and Ellis. Jan. 28 PM Tr. at 5:5-8, 5:13-14, 6:11-7:3, 9:14-21 (Long). Strands were then formed by polymerizing this novel non-Tris monomer and MMA as comonomers. Jan. 28 PM Tr. at 5:3-8, 7:7-10 (Long); JTX-13 at col.7 lines 39-41.
61. Second, Tanaka proposed a variety of cross-linking agents, including some cross-linkers that were not employed by Gaylord and Ellis. Although Tanaka stated that a cross-linker used by Gaylord, ethylene glycol dimethacrylate, could be used in his polymer, JTX-13 at col.8 lines 2-14, Tanaka's "preferred" cross-linking agents were multifunctional siloxanyl alkyl esters having a siloxane bond (which he described as formula [IV] cross-linkers) and multifunctional siloxanyl alkanol esters, also having a siloxane bond (formula [V] cross-linkers). JTX-13 at col.8 lines 11-46; see also Jan. 28 PM Tr. at 77:25-78:22 (Long); JTX-16 at 5 (Board Finding No. 26).
62. Tanaka says that these cross-linking agents are preferred because the siloxane bonds provide increased oxygen permeability to the cross-linked copolymer:
JTX-13 at col.8 lines 35-39; see Jan. 28 PM Tr. at 77:25-78:16 (Long); JTX-16 at 5-6 (Board Finding 27).
63. Tanaka states that the novel siloxanyl alkynol esters of formula [V] are "particularly useful" because they contain hydrophilic hydroxyl groups. That is, not only do these cross-linkers promote a material's oxygen permeability, but they also promote its wettability. JTX-13 at col.8 lines 39-46.
64. The multifunctional siloxanyl alkyl esters referenced by Tanaka had been known in the field of polymer chemistry since at least 1958, and had been disclosed in the Mercker Patent, see PTX-1; Jan. 28 PM Tr. at 107:8-23 (Long), but there is no evidence that it had been purposely employed in contact lens production prior to Tanaka. See Jan. 28 PM Tr. at 107:8-108:6.
65. Tanaka's patent was issued on November 25, 1980. JTX-13 at [45].
66. Beginning around 1977, Russell Neefe undertook to create a rigid gas permeable material suitable for contact lenses. Jan. 29 PM Tr. at 6:18-22 (Neefe).
67. At some point between 1977 and 1980, Neefe had the idea to cross-link the silicone-containing Tris monomer not with the cross-linkers used by Gaylord, Ellis, or Novicky, but with a cross-linking agent based on Tris. Jan. 29 PM Tr. at 15:16-23 (Neefe). This type of cross-linking agent—a multifunctional siloxanyl alkyl ester—was one of the agents preferred by Tanaka. See FF. 61-62.
68. The initial material created by Neefe using the process of claim 1 had a Dk value of 14. Jan. 29 PM Tr. at 19:15-20:1 (Neefe).
69. On September 8, 1980, Russell Neefe submitted his application for the patent at issue in this suit. A patent was issued to Neefe on December 15, 1981. JTX-1 at [45].
70. The Neefe Patent is entitled "Method of Making a Contact Lens Material With Increased Oxygen Permeability." JTX-1.
71. The Summary of Invention in the Neefe Patent specification states that the "primary object of this invention is to provide a novel contact lens material which is prepared from a combination of monomers so as to have high oxygen, carbon dioxide permeability, and a hydrophilic surface." JTX-1 at col.1 lines 61-64.
72. The Neefe Patent contains four claims, three of which were not subject to reexamination because the PTO found no substantial question of patentability as to those claims. JTX-34 at 1112.
73. As noted supra at 56, claim 1 of the Neefe Patent outlines a six-step process for making a rigid gas permeable contact lens material, labeled (a) through (f). JTX-1 at col.5 lines 38-64.
74. The first five steps of the claim (steps (a)-(e)) recite a process of making 1,1,1-tris(trimethylsiloxy)methacryloxypropylsilane, or "Tris." JTX-1 at col.5 lines 44-54; JTX-16 at 2 (Board Findings 4-6); Jan. 28 AM Tr. at 69:1-70:5 (Long). There is no dispute that Tris was known in the prior art. Director's PFF. 34; Dome's Resp. PFF. 34.
75. Step (f) of the claim instructs that four chemical ingredients, including Tris, are combined to form "an oxygen permeable contact lens material." JTX-1 at col.5 lines 55-64.
76. The four ingredients combined in step (f) are as follows: (1) "from 5% to 90% by weight" of the Tris monomer; (2) from "3% to 90% by weight of an ester of acrylic or methacrylic acid;" (3) "from 0.5% to 90% by weight of a surface wetting agent;" and (4) "from 0.01% to 90% by weight of an oxygen permeable crosslinking agent selected from the class of multifunctional siloxanyl alkyl esters." JTX-1 at col.5 lines 55-64; id., Certificate of Correction.
77. The first three ingredients listed in step (f) of claim 1 of the Neefe patent were previously disclosed by Gaylord. The only significant difference between the contact lens material taught by Gaylord and the contact lens material in claim 1 of the Neefe Patent is the fourth ingredient: Gaylord's material includes a hydrophilic cross-linking agent rather than the hydrophobic multifunctional siloxanyl alkyl ester used by Neefe. JTX-8 at col.6 lines 3-12;
78. As noted supra at FF. 61-63, Tanaka suggested the use of a siloxanyl alkyl ester cross-linker in order to promote oxygen permeability, although Tanaka suggested its use with a different (non-Tris) monomer.
79. Four years later, Neefe created another material using the process of claim 1 of the Neefe Patent, which was commercialized and sold under the trade name TransAire. Jan. 30 AM Tr. at 79:25-80:4, 83:3-5 (Neefe). The TransAire polymer had a Dk value of 45. Jan. 30 AM Tr. at 81:15-18 (Neefe); JTX-27 at 273.
80. A person of ordinary skill in the art of making RGP contact lens materials, as of September 8, 1980, would have had at least an undergraduate degree—and very likely a graduate degree or some graduate training—in chemistry, coupled with experience in the development, manufacture and use of polymers suitable for the manufacture of RGP contact lenses. Jan. 28 PM Tr. at 60:15-19 (Long).
81. The person having ordinary skill in the art was aware of the reasons for and desirability of high oxygen permeability in contact lens materials. JTX-16 at 8 (Board Finding 50); see Director's PFF. 46; Dome's Resp. PFF. 46.
82. A person of ordinary skill in the art would have fully understood the copolymerization chemistry used to make contact lens materials, including the mechanism involved in cross-linking different comonomers. JTX-16 at 8:10-23; see Director's PFF. 47; Dome's Resp. PFF. 47; Dome's PFF. 69; Director's Resp. PFF. at 3, 5-6.
83. The person having ordinary skill in the art also would have understood and been familiar with the processes and chemistry for making the comonomers that are copolymerized in making contact lens materials. JTX-16 at 8 (Board Finding 53); see Director's PFF. 49; Dome's Resp. PFF. 49.
84. One having ordinary skill in the art would have been familiar with the properties of Tris and the chemistry necessary to make it. JTX-16 at 8 (Board Finding 54); see Director's PFF. 50; Dome's Resp. PFF. 50.
85. One having ordinary skill in the art would have understood that cross-linking takes place through terminal unsaturated carbon bonds. JTX-16 at 8, 16; see Director's PFF. 48, 84; Dome's Resp. PFF. 48, 84.
86. One having ordinary skill in the art would have understood that ethylene glycol dimethacrylate, described as a cross-linker by both Gaylord and Tanaka, may be represented by the following formula showing terminal unsaturated carbons (= CH2):
One having ordinary skill in the art would have understood that Tanaka's preferred oxygen permeable cross-linkers similarly have terminal unsaturated carbons (=CH2). For example, the multifunctional siloxanyl alkyl esters employed by Tanaka include those represented by the following general formula:
JTX-16 at 15 n.5; Director's PFF. 83; Dome's Resp. PFF. 83.
87. A person of ordinary skill in the art would have expected that these multifunctional siloxanyl alkyl ester cross-linking agents, having terminal unsaturated carbons (= CH2), would be effective cross-linking agents with the comonomers suggested by Gaylord. See JTX-16 at 16.
88. The person having ordinary skill in the art would have recognized that the oxygen permeability of Tanaka's lens material was due in part to the use of Tanaka's preferred cross-linking agents, which contain siloxane bonds. See JTX-13 at col.8 lines 35-39; Jan. 28 PM Tr. at 79:15-16 (Long); see also JTX-16 at 6, 14.
89. A person of ordinary skill in the art would reasonably expect that combining the comonomers suggested by Gaylord and the multifunctional siloxanyl alkyl ester cross-linking agent suggested by Tanaka would likely yield positive results in terms of oxygen permeability. See JTX-16 at 6 (Board Finding 28); Director's PFF. 78-86; Dome's Resp. PFF. 78-86 (asserting that an artisan of ordinary skill would have been deterred from combining Gaylord's and Tanaka's compounds for other reasons, but not disputing that such artisan would know that these materials could be combined to promote oxygen permeability); Dome's Trial Brief at 4 ("It was known that incorporating a type of chemical called a `silicone' (of which Tris is an example) in the contact lens material would improve its oxygen permeability.").
As noted, a person of ordinary skill in the art would have known that the multifunctional siloxanyl alkyl ester cross-linking agent referenced by Tanaka could be used with the Tris monomer, and that such combination would promote oxygen permeability. See FF. 89. Nevertheless, Dome
Upon consideration of the entire record, the Court finds as follows:
90. A person of ordinary skill in the art at the time of the invention would understand that any candidate material for making RGP contact lenses must simultaneously achieve design goals that are often in tension with one another. Jan. 28 PM Tr. at 61:5-10 (Long).
91. Tanaka teaches that polymers "consisting essentially of" a siloxanyl alkyl ester (such as Tris) and having no hydrophilic groups have very strong water repelling properties and therefore are unsuitable for contact lenses. JTX-13 at col.3 lines 10-23.
92. Tanaka teaches that the water repelling nature of polysiloxanyl alkyl ester monomers can be repressed by reducing the number of hydrophobic alkylsiloxy groups in the polymer. Such reduction, however, will lead to a reduction in oxygen permeability:
JTX-13 at col.3 lines 41-51; see also Jan. 28 PM Tr. at 8:13-9:8 (Long).
93. Tanaka also warns that a polysiloxanyl alkyl ester monomer such as Tris could become opaque when combined with hydrophilic monomers.
JTX-13 at col.3 lines 23-41.
94. Tanaka sought to create a continuous wear lens (i.e., an extended or overnight wear lens), not a daily wear lens or a prolonged daily wear lens. JTX-13, Abstract (describing invention as contact lenses that "can be comfortably worn continuously for a long period of time"); id. at col.1 lines 9-10; id. at col.1 lines 31-32; id. at col.3 lines 50-51; id. at col.3 lines 60-63; id. at col.11 lines 4-5; id. at col.11 lines 13-14; id. at col.11 lines 50-52; id. at col.27 lines 43-65 (noting that Tanaka contact lenses "were worn on rabbit eyes continuously for 21 days," and "could be continuously worn without change in eyes").
96. The oxygen permeability of a contact lens worn in extended wear or continuous wear needs to be much greater than the oxygen permeability of a lens to be worn for daily wear. Jan. 30 AM Tr. at 21:20-24 (Benjamin).
97. Although Tanaka warned that it could be difficult to increase a Tris-based polymer's wettability simply by adding hydrophilic monomers, prior references in the art taught that hydrophilic monomers could be used, within limits, to offset hydrophobic monomers such as Tris.
98. For example, Gaylord discloses that other ingredients can be added to a siloxanyl alkyl ester to materially affect the basic properties of a contact lens material. Specifically, Gaylord discloses using from 30 to 90 parts by weight acrylic or methacrylic acid ester, JTX-8 at col.4 lines 14-16, both of which are hydrophilic. Jan. 28 PM Tr. at 64:11-19 (Long).
99. Gaylord also explains that, even if the resulting contact lens material is not sufficiently wettable on its own, "several alternate methods" can be used "to improve the wettability of" contact lenses. JTX-8 at col.5 lines 39-58.
100. For example, "wettability can be imparted to the copolymer by the addition of from about 0.1% to about 10% by weight of one or more hydrophilic monomers." JTX-8 at col.5 lines 42-45.
101. Gaylord also states that "the wettability of the surface of contact lenses made from the copolymers can be improved by the application of a wetting agent[,] . . . by exposure of the surface to a corona discharge or by chemical treatment of the surface with a strong oxidizing agent such as nitric acid." JTX-8 at col.5 lines 51-58.
102. Gaylord further describes that those methods are effective at yielding a wettable material—a lens made with 55 parts Tris (which is hydrophobic), 45 parts methyl methacrylate (which is hydrophilic), and 2 parts methacrylic acid (which is a hydrophilic wetting agent) "is readily wetted with a wetting agent solution." JTX-8 at col.8 lines 5-19.
103. Gaylord also states that these materials will yield a "transparent" material, JTX-8 at col.8 lines 5-22, and thus Gaylord teaches that Tris can be copolymerized with hydrophilic monomers like MMA and surface wetting agents without making the copolymer opaque.
104. In addition, Gaylord teaches that a material can contain relatively high amounts of hydrophobic monomers and still be wettable. For example, Gaylord discloses that lenses with as much as 70 parts by weight of Tris are wettable, even though Tris is hydrophobic. See JTX-8, Abstract; id. at col.1 lines 17-18; id. at col.12 line 50 (claiming material that is up to 70 parts by weight of Tris); id. at col.7 line 21 (disclosing material of 55 parts Tris); id. at col.7 line 38 (disclosing material of 60 parts Tris).
105. Claim 1 of the Neefe Patent permits as little as 0.01% of the hydrophobic cross-linking agent, along with 5% of Tris, which is hydrophobic, so it permits as
106. Dr. Long states that as of September 8, 1980, a person of ordinary skill in the art would not have reasonably expected that the siloxanyl alkyl ester cross-linker preferred by Tanaka could be used with a Tris-based polymer in order to create a contact lens. See Jan. 28 PM Tr. at 108:1-6. But this conclusion is not consistent with other evidence presented at trial. See FF. 90-105.
107. Dr. Long testified that he did not know what continuous wear or extended wear lenses are, and that such knowledge was beyond the scope of his synthetic polymer chemistry skills. Jan. 28 PM Tr. at 81:14-21 (Long). This lack of knowledge may have affected and limited Dr. Long's understanding of Tanaka and his teachings.
108. In light of Findings of Fact 90 through 107, the Court finds that even if the Tanaka patent "teaches away" from the use of hydrophobic compounds such as Tris, it only discourages using such compounds when seeking to make a material that "can be comfortably worn continuously for a long period of time." It did not teach away from using such compounds for daily wear or prolonged daily wear.
109. In light of Findings of Fact 90 through 108, the Court finds that a person of ordinary skill in the art would not be deterred, out of concerns about wettability or opacity, from using the Tris monomer suggested by Gaylord along with the siloxanyl alkyl ester cross-linker preferred by Tanaka to create a daily wear or prolonged daily wear contact lens, provided that other, hydrophilic comonomers also were employed.
Dome argues that the process recited in claim 1 of the Neefe Patent satisfied a long-felt need for a contact lens that could be worn throughout the entire day. Dome notes that a variety of first generation lenses (such as Polycon II and Boston II) based on prior art could not be comfortably worn from when the wearer woke up in the morning until she went to bed in the evening. By contrast, the Boston IV lens, a second generation lens that Dome contends embodies claim 1 of the Neefe Patent, could be worn without interruption from morning until evening. The Boston IV lens achieved considerable commercial success as compared to its predecessor, the Boston II lens, which Dome asserts was not manufactured in accordance with claim 1. Dome argues that the positive results achieved in the Boston IV lens and the ensuing commercial success provides objective evidence of the nonobviousness of claim 1. See Jan. 30 PM Tr. at 12:6-13:10.
The Director maintains that many of the assumptions underlying Dome's arguments are flawed. To begin with, the Director takes issues with Dome's assertion that the Boston IV lens embodies claim 1 of the Neefe Patent, since the Boston IV process does not strictly comply with the sequence of steps for making Tris as specified in claim 1. Therefore, according the Director, the popularity of Boston IV cannot be used to shed light on the novelty of claim 1. The Director next argues that the success of the Boston IV lens was attributable to a number of factors, only one of which possibly relates to the Neefe Patent. Finally, the Director contends that the positive, commercially desirable properties of the Boston IV lens are unlikely to be present in other embodiments
The parties' disagreements turn both on questions of law and questions of fact. The factual disputes center on how a person of ordinary skill in the art would interpret the language of claim 1 of the Neefe Patent; whether a person of ordinary skill in the art would view certain steps in the Boston IV and Boston II processes as equivalent to steps specified in claim 1; and the reasons for Boston IV's success. Upon consideration of the entire record, the Court finds as follows:
110. As noted supra at FF. 47-48, on May 1, 1979, a patent was issued for the invention of Edward J. Ellis and his colleague, working at the Polymer Technology Corporation ("PTC"), which is owned by Bausch & Lomb. JTX-9 at [54], [75], [45], [73].
111. Similar to the Gaylord polymer, the Ellis polymer used the hydrophobic Tris monomer, a hydrophilic MMA monomer, a hydrophilic methacrylic acid as a wetting agent, and traditional, hydrophilic cross-linking agents. Jan. 28 AM Tr. at 73:25-74:2 (Long); 75:1-11; JTX-9 at col.3 line 68, col.4 lines 24-27, col.5 line 4, col.10 lines 28-33.
112. The Ellis polymer differed from the Gaylord polymer, however, in that Ellis added an additional hydrophilic monomer called itaconate in order to improve the stability and the wettability of the polymer. Jan. 28 AM Tr. at 73:10-16, 74:2-14 (Long); JTX-4 at 64; JTX-9 col.10 lines 28-33.
113. Contact lenses incorporating the Ellis polymer were introduced into the marketplace in 1983 by PTC as the Boston II lens. JTX-10 at col.2 lines 48-51; PTX-3 at BL5513; see also JTX-4 at 64, 66.
114. A year later, in 1984, PTC introduced the Boston IV lens as part of a "second generation" of RGP contact lenses. Jan. 29 AM Tr. at 23:12-15, 55:5-7 (Melamed); Jan. 29 AM Tr. at 43:16-44:22.
115. Both the Boston II contact lens and the Boston IV contact lens are made from an oxygen permeable material formed by a process that includes the copolymerization of Tris by procedures specified in Bausch & Lomb manufacturing protocols. JTX-21 at BL8556-57. Both procedures begin with the synthesis of TX-91, a specific formulation of Tris. Jan. 28 PM Tr. at 56:4-7 (Long); JTX-17 at BL31.
116. As discussed in FF. 117 to FF. 129, the five step process used to formulate TX-91 corresponds to steps (a) through (e) of the Neefe Patent.
117. First, the production of TX-91, a specific formulation of Tris, begins by mixing 600 mL methacryloxypropyltrimethoxysilane ("MPS") and 1200 mL trimethylchlorosilane ("TMCS"), for a molar ratio of TMCS to MPS of 3.75 to 1, in a 3 liter round bottom flask. JTX-18 at BL3, Step 7.1.2.
118. This process is performed in the exact manner as set forth in step (a) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 27:20-28:2 (Long); JTX-1 at col.5 lines 38-64.
120. This combined use of one-third volume of water (which catalyzes the hydrolysis reaction) and an external ice/water bath (which acts as a heat sink to absorb the excess heat produced in the exothermic reaction) is not performed in the exact manner as any step recited in the Neefe Patent. See JTX-1 at col.5 lines 38-64. This combined use performs substantially the same functions, however, as the 3 to 10-fold excess volume of water recited in step (b) of claim 1 of the Neefe Patent (i.e., catalyzing the hydrolysis reaction and absorbing excess heat), in substantially the same way (i.e., by providing the water needed for incorporation during the chemical reaction and serving as a heat buffer), to achieve substantially the same result (i.e., forming Tris and limiting the formation of undesired by-products that can form under conditions of excessive heat). JTX-18 at BL4, step 7.1.3-7.1.4; Jan. 28 PM Tr. at 33:16-34:20 (Long); see also JTX-6 at col.1 lines 52-54.
121. Third, the mixture of MPS, TMCS, and water is stirred slowly for 12 to 16 hours. Jan. 28 PM Tr. at 36:1-14 (Long); JTX-18 at BL4, Step 7.1.5.
122. This process is performed in the exact manner as set forth in step (c) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 36:21-37:1 (Long); JTX-1 at col.5 lines 38-64.
123. Fourth, the mixture of MPS, TMCS, and water is transferred to a separatory funnel, allowed to separate, and the upper organic layer is retained. Jan. 28 PM Tr. at 37:21-25, 38:1-5 (Long); JTX-18 at BL4, Step 7.1.6.
124. Fifth, volatiles (including the unwanted by-product hexamethyldisiloxane) are then removed under vacuum using a rotary evaporator or its equivalent. Jan. 28 PM Tr. at 39:17-40:1 (Long); JTX-18 at BL4, Step 7.1.9. The mixture is then filtered. Jan. 28 PM Tr. at 38:9-17 (Long); JTX-18 at BL5, Step 7.2.2. See generally JX-18.
125. The separation step and the vacuum distillation and filtration steps correspond to steps (d) and (e) of claim 1 of the Neefe Patent. The order in which each action is performed, however, differs from the sequence described in claim 1, which requires that the upper organic layer of the mixture is "remove[d] and filter[ed]" in step (d), and that the hexamethyldisiloxane "is then removed by vacuum distillation" in step (e). JTX-1 at col.5 lines 51-54 (emphasis added).
126. Nevertheless, a person of ordinary skill in the art would view filtration followed by vacuuming as equivalent to vacuuming followed by filtration. Jan. 28 PM Tr. at 40:12-15, 54:23-25, 87:8-9, 94:14-15 (Long). The Court bases this finding on the following facts:
128. Tris dimer and Tris trimer are both in the class of multifunctional siloxanyl alkyl esters required for step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:6-59:1 (Long).
129. TX-91 is the first ingredient used in both the Boston II manufacturing process and the Boston IV process. See generally JX-18; Jan. 28 PM Tr. at 56:4-13 (Long); Jan. 28 PM Tr. at 56:4-7 (Long). From this point, however, the Boston II process and the Boston IV process diverge.
130. As noted, the first compound used in the Boston II copolymerization process is TX-91. Jan. 28 PM Tr. at 56:4-13 (Long).
131. TX-91, as prepared in steps (a) through (e) above, comprises approximately 41.7% by weight of the Boston II copolymer. JTX-17 at BL24, BL31. The main component of TX-91, the Tris monomer, therefore comprises 35.5% to 41.7% by weight of the Boston II copolymer. Jan. 28 PM Tr. at 56:14-15 (Long); JTX-17 at BL24, BL31.
132. This percentage of Tris falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 56:18-57:1 (Long); JTX-1 at col.5 lines 38-64.
133. The second comonomer used in the copolymerization process is an ester of acrylic or methacrylic acid. Jan. 28 PM Tr. at 57:2-8 (Long).
134. An ester of acrylic or methacrylic acid comprises 21.8% by weight of the copolymer. JTX-17 at BL24, BL31.
135. This percentage of an ester of acrylic or methacrylic acid falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 57:2-12 (Long); JTX-1 at col.5 lines 38-64.
136. The third class of comonomers used in the copolymerization process are the surface wetting agents tetraethyleneglycol dimethacrylate ("CL") and N-Nvinylpyrrolidone ("NVP"). Jan. 28 PM Tr. at 58:1-3 (Long).
137. Together, these surface wetting agents comprise 9.9% by weight of the copolymer. JTX-17 at BL24, BL31 (CL is 8.4% by weight; NVP is 1.5% by weight).
138. This percentage of surface wetting agents falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:1-5 (Long); JTX-1 at col.5 lines 38-64.
140. Multifunctional siloxanyl alkyl esters nevertheless are often present in the mixture used to create the Boston II lens. This is because, as noted supra at FF. 127-128, TX-91 consists of up to 15% Tris dimer or trimer, each of which is an example of the multifunctional siloxanyl alkyl ester called for in step (f) of claim 1. JTX-17 at BL 31; Jan. 28 PM Tr. at 23:8-16, 24:19-23, 98:18-99:3 (Long).
141. Neefe himself disclosed embodiments using Tris dimer or trimer as the cross-linking agent. Examples II and IV in the Neefe Patent specification employ a dimer of Tris. Jan. 28 PM Tr. at 17:24-18:2, 19:1-5 (Long); see also JTX-1 at col.3 lines 30-40, 62. Example VI of the Neefe Patent employs a trimer of Tris. JTX-1 at col.4 lines 36-37.
142. Because TX-91 makes up 41.7% of the Boston II lens by weight (JTX-17 at BL 24; Jan. 28 PM Tr. at 56:10-11 (Long)), the Boston II lens can be comprised up to 6.2% by weight of Tris dimer and trimer (i.e., 41.7% (percentage of TX-91 in the lens) multiplied by 15% (maximum percentage of Tris dimer and trimer in TX-91)). See Director's PFF. 149; Dome Resp. PFF. 149.
143. PTC sought to minimize the presence of dimers and trimers in at least one of its formulations of Tris. JTX-19 at BL 68, 70. There is no evidence, however, that the amount of Tris dimer or trimer was minimized below .01% by weight. In fact, PTC calculated that the Boston II lens contained approximately 1.3 mole percent of Tris dimer and trimer. JTX-21 at 8557, 8577.
144. If Tris dimer and trimer are present in TX-91, then they will be cross-linked in the copolymer. Jan. 28 PM Tr. at 97:18-98:6 (Long).
145. As noted supra at FF. 76, step (f) of claim 1 of the Neefe Patent requires that at least .01% of the hydrophobic cross-linking agent—such as Tris dimer or Tris trimer—be copolymerized with the Tris, the ester of acrylic or methacrylic acid, and the surface wetting agent. JTX-1 at col.5 lines 55-64.
146. The maximum amount of Tris dimer and trimer permitted in the Boston II lens—6.2%—falls well within the "0.01% to 90%" range of siloxanyl alkyl ester cross-linking agent required in Step (f) of claim 1 of the Neefe Patent. See JTX-1 at col.5 lines 55-64.
147. The minimum amount of Tris dimer and Tris permitted in the Boston II lens—0%—falls narrowly outside of the "0.01% to 90%" range of siloxanyl alkyl ester cross-linking agent required in Step (f) of claim 1 of the Neefe Patent. See id.
148. As noted supra at FF. 48, the oxygen permeability of the Boston II lenses consistently was reported to be approximately 12 to 14 Dk. Jan. 29 AM Tr. at 25:22-25, 54:4-9 (Melamed); Jan. 30 AM Tr. at 69:25-70:2, 75:21-25 (Benjamin); JTX-4 at 66 (12-14 Dk); JTX-12 at 238 (12.6 Dk); JTX-21 at BL8556 (14.6 Dk); JTX-27 at 273 (12 Dk); PTX-2 at BL4760 (14.6 Dk); but see JTX-20 at BL8328 (16.4 Dk).
149. Like the Boston II lens, the first compound employed in the Boston IV copolymerization process is TX-91. Jan. 28 PM Tr. at 56:4-7 (Long); JTX-17 at BL31.
150. Sufficient amounts of TX-91 are used so that the Tris monomer comprises 38.3% to 41.0% by weight of the copolymer. JTX-17 at BL31; Jan. 28 PM Tr. at 56:14-15 (Long).
151. This percentage of Tris monomer falls within the range specified in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 56:18-57:1 (Long).
152. As in the Boston II process, the second comonomer employed in the copolymerization set forth in the Boston IV process is an ester of acrylic or methacrylic acid. Jan. 28 PM Tr. at 57:2-8 (Long).
153. An ester of acrylic or methacrylic acid comprises 19.7% by weight of the copolymer used for the Boston IV process. JTX-17 at BL24, BL31.
154. This amount of ester of acrylic or methacrylic acid falls within the range specified in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 57:2-12 (Long).
155. As in the Boston II process, the third class of comonomers employed in the copolymerization set forth in the Boston IV process are the surface wetting agents tetraethylene glycol dimethacrylate and N-Nvinylpyrrolidone. Jan. 28 PM Tr. at 58:1-3 (Long).
156. Together, these surface wetting agents comprise 8.1% by weight of the copolymer. JTX-17 at BL24, BL31 (CL is 2.9% by weight; NVP is 5.5% by weight).
157. This percentage of surface wetting agents falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:1-5 (Long).
158. Unlike in the Boston II process, in the Boston IV process TX-91 is modified to become TX-82. TX-82 is prepared by adding substantial quantities of Tris dimer and Tris trimer to the TX-91 formulation produced through steps (a) through (e), so as to increase the percentage of Tris dimer to between 19.5 and 21 percent and Tris trimer to between 3 and 9.5 percent. Jan. 28 PM Tr. at 24:5-18, 58:20-59:1 (Long); JTX-17 at BL24, BL31; JTX-21 at BL8599-8603.
159. As noted supra at FF. 128, Tris dimer and trimer are each an "oxygen permeable crosslinking agent selected from the class of multifunctional siloxanyl alkyl esters" as specified in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:6-24 (Long).
160. These percentages of Tris dimer and trimer fall within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:15-59:1, 59:25-60:7 (Long); JTX-1 at col.5 lines 38-64.
161. The reported oxygen permeability of the Boston IV lens was 19 to 28 Dk, depending on the measurement technique used. Jan. 29 AM Tr. at 26:1-2, 56:1-4 (Melamed); Jan. 30 AM Tr. at 37:24, 66:12-13 (Benjamin); JTX-4 at 66; JTX-21 at BL8556, BL8578; JTX-22 at BL8739; JTX-23; JTX-27 at 273; PTX-2 at BL4760, BL4776; PTX-3 at BL5507.
162. The only substantial difference between the Boston II and the Boston IV manufacturing processes was that the Boston IV process involved the purposeful addition of Tris dimer and trimer. One internal
163. There was at least a 50% increase in the oxygen permeability of the Boston IV polymer over the Boston II polymer without impairment of wettability. Jan. 29 AM Tr. at 26:1-4, 62:11-13 (Melamed); JTX-4 at 66; PTX-3 at BL5513.
164. When calculating how much oxygen passes through an actual lens, one considers its oxygen transmissibility, which takes into account the material's thickness. Jan. 29 AM Tr. at 63:21-22 (Melamed); Jan. 30 AM Tr. at 23:18-19 (Benjamin); JTX-4 at 62.
165. Oxygen transmissibility is expressed as Dk/L, where Dk is the oxygen permeability and L is the thickness of the given polymer. Jan. 29 AM Tr. at 65:11-14 (Melamed); JTX-4 at 62.
166. The Dk/L of a contact lens must be approximately 18 to 20 to prevent damage to the cornea over the course of a prolonged wearing day. JTX-26 at 11.3 ("To produce virtually no change in corneal thickness under daily wear conditions, a lens must provide an equivalent oxygen percentage (EOP) of no less than 10%. Theoretically, this requires a Dk/L of approximately 18-20."). Jan. 29 AM Tr. at 91:13-21 (Melamed).
167. The oxygen transmissibility of the Boston IV lens is approximately 18.7 Dk/L, and thus the lens is suitable for prolonged daily wear. JTX-4 at 206; Jan. 29 AM Tr. at 65:15-17, 76:7-20 (Melamed); JTX-26 at 11.3-11.4. By contrast, the oxygen transmissibility of the Boston II lens is approximately 8.0 to 9.3 Dk/L, and thus the Boston II is not suitable for prolonged daily wear. PTX-2 at BL4760; JTX-4 at 66, 206; Jan. 29 AM Tr. at 75:22-76:3 (Melamed); see also Dome's PFF. 291-96; Director's Resp. PFF. at 14.
168. The Boston IV lens was an improvement over the Boston II lens because of increased oxygen permeability and oxygen transmissibility. Jan. 29 AM Tr. at 27:8-13 (Melamed).
169. The Boston IV lens largely displaced sales of the Boston II lens. Jan. 29 AM Tr. at 45:7-16 (Melamed); PTX-3 at BL5513; JTX-31 at BL8309.
170. By 1988, the Boston IV lens commanded 65% of Bausch & Lomb's total material sales distribution, while the Boston II lens accounted for 10% of sales. JTX-31 at BL8309.
171. The Boston IV lens is still widely available today. Jan. 29 AM Tr. at 46:12-13 (Melamed); JTX-4 at 17.
172. Other factors in addition to increased oxygen permeability likely contributed to the Boston IV lens' commercial success: (i) patients could easily get a replacement lens for the Boston IV lens because they were "consistent and readily reproducible" (Jan. 29 AM Tr. at 68:11-24 (Melamed)); (ii) patients were attracted to the Boston IV lens because it was durable and lasted a long time (id. at 68:25-69:10 (Melamed)); (iii) the long-term costs of purchasing the Boston IV lens were low for the consumer, so economics was an additional attractive feature of the lens (id. at 71:3-12 (Melamed)); and (iv) Bausch & Lomb heavily promoted the Boston IV lens, but not other lenses with higher oxygen permeability (e.g., the Boston Equalens lens) (id. at 80:8-23 (Melamed)).
173. The ranges identified in step (f) of the Neefe Patent are very broad. For example, as noted supra at FF. 104, claim
174. Dome did not introduce any expert evidence showing that a contact lens made from ingredients in the amounts at the ends of those ranges would be sufficiently oxygen permeable or wettable.
175. For example, Dome's expert, Dr. Long, did not know whether a contact lens material that is 5% by weight Tris monomer, 90% by weight MMA, 4.99% by weight surface wetting agent, and 0.01% by weight a multifunctional siloxanyl alkyl ester would be sufficiently oxygen permeable, even though such a lens material would fall within the scope of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 86:7-23 (Long).
176. Nor did Dr. Long know whether a lens material that is 90% by weight Tris monomer, 3% by weight MMA, 0.5% by weight surface wetting agent, and 6.5% by weight Tris dimer as a cross-linker would be wettable, even though such a lens material would fall within the scope of claim 1 of the Neefe patent. Jan. 28 PM Tr. at 85:20-86:6 (Long).
177. Based on the evidence introduced at trial regarding the Boston II lens, a person of ordinary skill in the art would expect that a contact lens material comprised 35.5% to 41.7% by weight of Tris monomer, 21.8% by weight of ester of acrylic or methacrylic acid, 9.9% by weight of surface wetting agents tetraethyleneglycol dimethacrylate and N-Nvinylpyrrolidone, and between .01% and 6.2% by weight of Tris dimer and trimer, and manufactured in accordance with claim 1, would be wettable and would have an oxygen permeability of approximately 12 to 14 Dk. See FF. 131, 134, 137, 140, 142, 144, 148.
178. As noted supra at FF. 68, the initial material created by Neefe using the process of claim 1 had a Dk value of 14. The parties did not introduce any evidence at trial about how much of each ingredient (Tris monomer, MMA, surface wetting agent, and multifunctional siloxanyl alkyl ester) was used in the manufacturing process of that material.
179. As noted supra at FF. 79, the TransAire polymer, which was based on claim 1 of the Neefe patent, had a Dk value of 45. The parties did not introduce any evidence at trial about how much of each ingredient (Tris monomer, MMA, surface wetting agent, and multifunctional siloxanyl alkyl ester) was used in the TransAire manufacturing process.
Once the PTO has determined that "a substantial new question of patentability" is raised by a request for reexamination, the PTO initiates a reexamination proceeding. In re Swanson, 540 F.3d 1368, 1375 (Fed.Cir. 2008) (quoting 35 U.S.C. § 303(a)). In a reexamination proceeding, as in the initial examination of a patent application, the patent examiner bears the initial burden of showing by a preponderance of the evidence that the invention is unpatentable as obvious. See Rambus Inc. v. Rea, 731 F.3d 1248, 1255 (Fed.Cir. 2013) ("In reexamination proceedings, `a preponderance of the evidence must show nonpatentability before the PTO may reject the claims of a patent application.'") (internal quotation omitted); In re Etter, 756 F.2d 852, 856 (Fed.Cir. 1985) (en banc). Once a prima facie showing of obviousness is made, however, the
Dome objects to the application of this legal standard here, arguing that claim 1 of the Neefe Patent may be cancelled only if the Director proves obviousness under a clear and convincing evidence standard. In support of its position, Dome points to the standard of proof in patent infringement proceedings initiated under 35 U.S.C. § 282. See Dome's Prop. Concl. Law 11 (citing Microsoft Corp. v. i4i Limited Partnership, ___ U.S. ___, 131 S.Ct. 2238, 180 L.Ed.2d 131 (2011)). In Section 282 proceedings, a party accused of infringement may claim, as an affirmative defense, that the relevant patent is invalid due to obviousness. To prevail on this defense, the accused infringer must show obviousness by clear and convincing evidence. Section 282 is a fundamentally different context than the present one, and the burdens of proof governing those proceedings are inapplicable here. See In re Swanson, 540 F.3d at 1377 (noting that PTO examination and reexamination proceedings "have distinctly different standards, parties, purposes, and outcomes" than Section 282 infringement proceedings); In re Etter, 756 F.2d at 855-59; cf. Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1260 (Fed.Cir. 2012) (noting that the clear and convincing standard applicable in Section 282 proceedings is rooted in a "necessary deference to the PTO") (internal quotation omitted).
The Court therefore considers whether the Director has shown by a preponderance of the evidence that claim 1 of the Neefe Patent is prima facie obvious, and, if so, whether Dome has rebutted this initial showing.
A party subject to an adverse reexamination decision by the Board may seek review of that decision in this Court under 35 U.S.C. § 145, or it may appeal the decision directly to the Federal Circuit pursuant to 35 U.S.C. § 141.
"Whether a claim would have been obvious under 35 U.S.C. § 103(a) is a legal conclusion based on underlying factual determinations." Rambus Inc. v. Rea, 731 F.3d at 1251-52 (citing In re Kotzab, 217 F.3d 1365, 1369 (Fed.Cir. 2000)). These factual determinations "include (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of non-obviousness." Id. at 1251 (citing Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966)). The inquiry into obviousness "entails `an expansive and flexible approach.'" Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d at 1259 (quoting KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007)). If any embodiment within the scope of the claim is determined to be obvious, then the entire claim is unpatentable for obviousness, regardless of whether other embodiments are nonobvious. See ArcelorMittal France v. AK Steel Corp., 700 F.3d 1314, 1325 (Fed.Cir. 2012) ("`[C]laims which are broad enough to read on obvious subject matter are unpatentable even though they also read on nonobvious subject matter.'") (quoting Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1328 n. 4 (Fed.Cir. 2008)).
It is undisputed that each of the compounds recited in claim 1 of the Neefe Patent—the Tris monomer, the ester of acrylic or methacrylic acid, the surface wetting agent, and the siloxanyl alkyl ester cross-linking agent—was known in the prior art. This fact alone, however, does not establish obviousness. KSR Int'l Co. v. Teleflex Inc., 550 U.S. at 418-19, 127 S.Ct. 1727 ("[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art."); see also Stryker Spine v. Biedermann Motech GmbH, 750 F.Supp.2d 107, 122 (D.D.C.2010). Where all of the elements of a claim are known in the prior art, as is the case here, the obviousness inquiry generally will turn on two factual questions:
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1164 (Fed.Cir. 2006) (quoting Velander v. Garner, 348 F.3d 1359, 1363 (Fed. Cir. 2003)); see also In re Rosuvastatin Calcium Patent Litig., 703 F.3d 511, 518 (Fed.Cir. 2012) ("[I]n cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.") (internal quotation marks omitted).
In this case, the Director has demonstrated both the reason for combining the compounds recited in claim 1 of the Neefe Patent and a reasonable expectation of success. A person of ordinary skill in the art would have known that the ideal contact lens would have a relatively high level of oxygen permeability, and would be motivated to combine comonomers and cross-linkers to create an oxygen permeable polymer. See FF. 8-11, 81. This artisan also would have known that the siloxanyl alkyl ester cross-linkers discussed by Tanaka promoted oxygen permeability, as these cross-linkers contained a siloxane bond. FF. 61-62. And the artisan would have known that the siloxanyl alkyl ester cross-linkers could effectively cross-link the comonomers used by Gaylord and Ellis. FF. 80-88. It therefore would have been obvious to a person of ordinary skill in the art that these materials, when combined with traditional hydrophilic comonomers and wetting agents, could potentially be used to create an oxygen permeable contact lens. FF. 89. The Director has established a prima facie case of obviousness, and the burden shifts to Dome to prove nonobviousness.
A patentee may rebut a prima facie showing of obviousness by demonstrating that the prior art "teaches away" from the claimed invention in any material respect. In re Peterson, 315 F.3d 1325, 1331 (Fed.Cir. 2003); see KSR Int'l Co. v. Teleflex Inc., 550 U.S. at 416, 127 S.Ct. 1727 ("[W]hen the prior art teaches away from combining certain known elements, discovery of a successful means of combining them is more likely to be nonobvious."). Dome has taken this tack, arguing that while it may have been apparent that both Tris monomer and siloxanyl alkyl ester cross-linker promote oxygen permeability, the prior art "taught away" from attempting this combination.
"A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant." In re Gurley, 27 F.3d 551, 553 (Fed.Cir. 1994) (collecting cases). The degree to which a reference teaches away will depend on the particular facts, but the basic question is whether the reference "suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant." Id. "What a reference teaches and whether a person of ordinary skill in the art would have been motivated to combine the teachings of separate references are questions of fact." Pregis Corp. v. Kappos, 700 F.3d 1348, 1353 (Fed.Cir. 2012). When considering apparently conflicting references in the prior art, the fact-finder must weigh each reference "for its power to suggest solutions to an artisan of ordinary skill . . . consider[ing] the degree to which one reference might accurately discredit another." Medichem, S.A. v. Rolabo, S.L., 437 F.3d at 1165 (quoting In re Young, 927 F.2d 588, 591 (Fed.Cir. 1991)).
As discussed above, see FF. 90-109, the prior references of Tanaka did not teach away from combining Tris with a siloxanyl
The Court therefore concludes that Dome has not rebutted the prima facie case of obviousness by demonstrating that the prior art taught away from the method recited in claim 1.
Dome also attempts to rebut the Director's prima facie case using evidence of secondary considerations, and in particular, evidence of commercial success. Secondary considerations, "[s]uch as commercial success, long felt but unsolved needs, failure of others, etc.," often can "give light to the circumstances surrounding the origin of the subject matter sought to be patented." KSR Int'l Co. v. Teleflex Inc., 550 U.S. at 406, 127 S.Ct. 1727 (quoting Graham v. John Deere Co. of Kansas City, 383 U.S. at 17-18, 86 S.Ct. 684). Evidence that a patented invention attained significant commercial success may provide an independent basis for inferring that the invention was not obvious, "because the law presumes an idea would successfully have been brought to market
Dome asserts that an embodiment of claim 1 achieved unexpected results that led to substantial commercial success. Dome also argues, with less force, that this embodiment satisfied a long felt but unsolved need. See, e.g., Dome's PFF. 351-402; Dome's Prop. Concl. Law at 36-40, 52; Dome Resp. Prop. Concl. Law 159, 194-95, 199, 229-30. The Director contends that the evidence presented by Dome is irrelevant and unpersuasive.
Dome focuses on the commercial success of the Boston IV lens, which, according to Dome, was manufactured using the process recited in claim 1 of the Neefe Patent. It is undisputed that the Boston IV lens achieved significant commercial success over prior Bausch & Lomb RGP lenses. See FF.169-71. But this success is only relevant to the obviousness inquiry if Dome can establish the following: first, that the Boston IV lens embodies claim 1 of the Neefe Patent—that is, that the lens is made in accordance with claim 1 of the Neefe Patent, see Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed.Cir. 2000); second, that the success of the Boston IV lens was the result of the novel feature claimed in the Neefe Patent, and not the result of some feature in the prior art, or some unrelated feature such as increased marketing, see Tokai Corp. v. Easton Enterprises, Inc., 632 F.3d 1358, 1369 (Fed.Cir. 2011); and third, that other embodiments of claim 1 could be expected to exhibit the same commercially beneficial properties exhibited by the Boston IV lens, see MeadWestVaco Corp. v. Rexam Beauty & Closures, Inc., 731 F.3d 1258, 1264-65 (Fed. Cir. 2013).
As discussed below, the Court agrees with Dome that there is a product—the Boston IV lens—that embodies claim 1 of the Neefe Patent and that achieved some commercial success. But the Court also finds that Dome has failed to present persuasive evidence that the success of the Boston IV lens is the result of the novel feature claimed in the Neefe Patent, or that other embodiments of claim 1 could be expected to exhibit the same commercially beneficial properties as those possessed by the Boston IV lens. The Court discusses each of these points in turn.
Although neither Neefe nor Dome created the Boston IV lens, the success of this product nevertheless may shed light on the obviousness (or nonobviousness) of Neefe's invention, so long as Dome shows that the Boston IV lens "embodies the claimed features" of the patented invention—i.e., that it is made in accordance with claim 1 of the Neefe Patent. Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d at 1130.
As noted supra at FF. 149-159, the Boston IV lens is manufactured using the following materials: 38.3% to 41.0% by weight of Tris; 19.7% of an ester of acrylic or methacrylic acid; 8.1% of surface wetting agents (tetraethylene glycol dimethacrylate and N-Nvinylpyrrolidone); and 19.5 to 21% and 3 to 9.5%, respectively, of Tris dimer and Tris trimer. These ranges fall within the ranges recited in claim 1 of the Neefe Patent, which calls for from 5% to 90% by weight of Tris; from 3% to 90% of an ester of acrylic or methacrylic acid; from .5% to 90% of a surface wetting agents; and from .01% to 90% of a siloxanyl alkyl ester cross-linker, such as Tris dimer or trimer. See FF. 76. But as the Director points out, there are two ways in which the synthesis of these compounds in the Boston IV lens process appears to deviate from the process recited in claim 1.
First, as discussed in FF. 123-125, the manufacture of the Boston IV lens requires that two steps—the vacuuming and the filtration of unwanted byproducts—occur in a different order than the order recited in claim 1 of the Neefe Patent. Generally speaking, however, a claim is not restricted to the performance of its steps in the order recited where sequence is not a clear limitation in the claim, and where neither logic nor any aspect of the specification or prosecution history requires a limiting construction. See Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1370-71 (Fed.Cir. 2003); cf. Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999) ("Although not every process claim is limited to the performance of its steps in the order written, the language of the claim, the specification and the prosecution history support a limiting construction in this case."). Although the ordering of the steps and the use of the word "then" suggests an order, neither logic nor anything in the specification or prosecution history suggests that the order of these steps would matter. See FF. 126. The Court therefore finds that the vacuuming and filtering elements recited in claim 1 are literally present in the Boston IV lens, and that the sequence of these steps is not a separate limitation of the claim. The variation in sequence does not take the Boston IV lens outside the scope of claim 1.
Second, claim 1 of the Neefe Patent requires at step (b) that the mixture of methacryl-oxypropyltrimethoxysilane and trimethylchlorosilane is added to water whose volume is from 3 to 10 times that of the mixture. See JTX-1 at col.5 lines 38-64. By contrast, the Boston IV manufacturing process calls for the addition of one-third volume of water to this mixture of methacryloxypropyltrimethoxysilane and trimethylchlorosilane, followed by an external ice/water bath. See FF. 119. Both parties agree that this step of the Boston IV process is different from step (b) of claim 1; the water addition element of
The doctrine of equivalents arose in the context of infringement disputes, and it "grow[s] out of a legally implied term in each patent claim that `the claim extends to the thing patented, however its form or proportions may be varied.'" Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 35, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997); see also Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 733, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002) ("The doctrine of equivalents allows the patentee to claim those insubstantial alterations that were not captured in drafting the original patent claim but which could be created through trivial changes."). To evaluate whether a product or process infringes under the doctrine of equivalents, the court asks "whether an asserted equivalent represents an `insubstantial difference' from the claimed element, or `whether the substitute element matches the function, way, and result of the claimed element.'" Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1356 (Fed.Cir. 2012) (quoting Warner-Jenkinson Co. v. Hilton Davis Chemical, 520 U.S. at 40, 117 S.Ct. 1040)).
Although neither party has pointed to any case directly addressing this question, the Court is persuaded that the commercial success of a product that infringes a patent claim under the doctrine of equivalents can inform whether the patent claim is obvious. To begin with, the Director's contention that a process that infringes by equivalence is outside the scope of a claim is inconsistent with the established principle that "[t]he scope of a patent is not limited to its literal terms but instead embraces all equivalents to the claims described." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. at 732, 122 S.Ct. 1831. In this vein, courts have considered the commercial success of a competitor's infringing product or process as a secondary consideration, without distinguishing between literal infringement or infringement by equivalence. See, e.g., Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d at 1130. Moreover, fact-finders in patent cases are instructed to take an "expansive and flexible approach" when considering obviousness. KSR Int'l Co. v. Teleflex Inc., 550 U.S. at 415, 127 S.Ct. 1727. Where the differences between the process used to create a successful product and the process claimed in the patent are insignificant, and where all evidence indicates that a product manufactured in strict accordance with the claim language would be identical to the successful, equivalent product, the commercial success of the equivalent product can shed light on the patent's obviousness. The Court therefore finds that the Boston IV lens falls within the scope of claim 1 for purposes of the obviousness inquiry.
In order to rely on the commercial success of the Boston IV lens as evidence of nonobviousness, Dome must show a legally and factually sufficient connection—a
As discussed in the preceding subsection, the Boston IV lens falls within the scope of claim 1 of the Neefe patent. And as noted, the parties do not dispute that the Boston IV lens achieved significant commercial success over prior Bausch & Lomb rigid contact lens products. See FF. 169-171. Dome therefore is entitled to a presumption that this commercial success relates to claim 1 of the Boston IV lens. Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d at 1392. But several factors undercut the persuasiveness of the evidence offered at trial.
First, the evidence of commercial success in the market is not particularly strong. Although Dome introduced evidence that the Boston IV lens achieved significant commercial success over prior Bausch & Lomb products, there is little evidence in the record of this product's success as compared to competitors' products. Rather, other RGP lenses with comparable or improved oxygen permeability levels came on the market at or near the same time, and there is no evidence that the Neefe process was used in developing these lenses. See JTX-4 at 206; JTX-26 at 11.3-11.4; JTX-27 at 23. Dome puts forth a narrative that could be compelling—artisans struggling in vain to create an extended wear lens, a problem finally solved by Neefe, to great commercial advantage—but provides no market data to support this narrative.
Second, on the issue of nexus, Dome has done little more than show that the Boston IV lens falls within the scope of claim 1 and achieved some commercial success. To bolster its nexus argument, Dome introduced the testimony of Dr. Mark Melamed, who explained why oxygen permeability would be a desirable property, and the Court has no doubt that increased oxygen permeability was one of the reasons for the Boston IV's popularity. See FF. 8-13, 81, 168. But Dr. Melamed's suggestion that oxygen permeability drove Boston IV's success is not reliable expert testimony, as such statements are outside the scope of his medical expertise. Moreover, Dr. Melamed himself indicated that at least some of the commercial success of
Dome also attempted to show a nexus by contrasting the successful Boston IV lens, which falls within claim 1, with the less successful Boston II lens, which, according to Dome, does not. For the reasons described below—reasons that intersect with the commensurateness requirement—this evidence is not persuasive.
For evidence of secondary considerations such as commercial success to be persuasive, the evidence "must be commensurate in scope with the claims which the evidence is offered to support." MeadWestVaco Corp. v. Rexam Beauty & Closures, Inc., 731 F.3d at 1264-65 (internal quotation omitted). Evidence of secondary considerations "is not commensurate with the claims if the claims are broader than the scope" of such evidence. Joy Technologies, Inc. v. Manbeck, 751 F.Supp. 225, 229 (D.D.C. 1990) aff'd, 959 F.2d 226 (Fed.Cir. 1992). "The claims are broader in scope than the objective evidence if a limitation or element recited in the claim is broader than the limitation or element in the objective evidence. . . or if the objective evidence contains limitations or elements not recited in the claims." Id. at 229-30 (citations omitted).
At least two rationales underlie the commensurateness requirement. First, a claim can be patented only if it is nonobvious throughout the range of the patent claim. Evidence of nonobviousness of one embodiment in a broad claim is of limited value, as it leaves open the question of whether other embodiments were obvious. See, e.g., Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1336 (Fed.Cir. 2010) (rejecting evidence that claimed invention solved a longstanding problem, where claims were broad enough to cover both devices that solved the problem and devices that did not); In re Clemens, 622 F.2d 1029, 1036 (C.C.P.A.1980) (finding narrow range of data could not "be reasonably extended to prove the unobviousness of a broader claimed range"); In re Tiffin, 448 F.2d 791, 792 (C.C.P.A. 1971) ("the objective evidence of non-obviousness is not commensurate with the scope of claims 1-3 and 10-16, reciting `containers' generally, but establishes non-obviousness only with respect to `cups' and processes of making them"). Second, evidence that commercially desirable properties are not commensurate with the patent claim suggests that the commercial success of one particular embodiment results from something different (or more specific) than the claim. In other words, if one embodiment of Neefe claim 1 has desirable properties, but another one does not, claim 1 does not necessarily cause those desirable properties. Viewed this way, the commensurateness requirement bears on the nexus inquiry, and has occasionally been described as such. See Regent Lighting Corp. v. FL Indus., Inc., 60 F.3d 840, ___, 1995 WL 331122, at *5 (Fed.Cir. 1995) (unpublished table disposition); Joy Technologies, Inc. v. Manbeck, 751 F.Supp. at 229.
As a general matter, the requirement that evidence of secondary considerations be reasonably commensurate with the scope of the claim "does not mean that an applicant is required to test every embodiment within the scope of his or her claims." In re Kao, 639 F.3d 1057, 1068 (Fed.Cir. 2011); In re DBC, 545 F.3d at 1384 ("[A] patentee need not show that all possible embodiments within the claims were successfully commercialized in order to rely on the success in the marketplace
First, it is undisputed that the material first manufactured by Neefe in accordance with his patent had a Dk value of 14. This level is only marginally better than the oxygen permeability levels obtained by the Polycon II lens based on Gaylord's patent, and is in the range obtained by the Boston II lens based on Ellis's patent. See FF. 40 (noting the 10 to 12 Dk for Polycon II lenses); FF. 148 (12-14 Dk for Boston II lenses). Dome agrees that this oxygen permeability level would be insufficient for prolonged daily wear and would not drive commercial success. See Dome Prop. Concl. Law 400 (discussing how the Boston II lens, with a Dk value of 12 to 14, accounted for only 10% of Bausch & Lomb's total material sales distribution).
Second, as noted supra at FF. 177, the evidence indicates that a contact lens material comprised of 35.5% to 41.7% by weight Tris monomer, 21.8% by weight ester of acrylic or methacrylic acid, 9.9% by weight surface wetting agents tetraethyleneglycol dimethacrylate and N-Nvinylpyrrolidone, and between .01% and 6.2% by weight Tris dimer and trimer—all amounts falling within the range specified in claim 1 of the Neefe Patent—and manufactured in accordance with that claim would have an oxygen permeability around 12 to 14 Dk. See FF. 131, 134, 137, 140, 142, 144, 148. This expectation would be reasonable because the Boston II lens, which has this composition, see FF. 131, 134, 137, 140, 142, has an oxygen permeability of 12 to 14 Dk, see FF. 148. Dome notes that the Boston II lens differs from the claim 1 process in that a Tris-based cross-linker is not deliberately added to the Boston II material—rather, it is a byproduct created during the process of making the Tris monomer, and it simply remains in the mixture. But the evidence indicates that this distinction is not a meaningful one in terms of the end result. As Dr. Long explained, Tris dimer and trimer will serve as cross-linking agents regardless of when they are created or added. FF. 144.
Although the Boston IV lens had increased oxygen permeability and achieved commercial success, there is not "an adequate basis to support the conclusion that other embodiments falling within [claim 1 of the Neefe Patent] will behave in the same manner." In re Kao, 639 F.3d at 1068. That is, there is no basis for inferring that other embodiments throughout the range of claim 1 will demonstrate high levels of oxygen permeability or achieve commercial success. Dome has thus failed to present evidence of commercial success that is commensurate with the broad scope of claim 1 of the Neefe Patent.
Although Dome focuses mainly on evidence of commercial success, Dome also argues that the Court should consider evidence of a long-felt, unsatisfied need for a contact lens suitable for prolonged daily wear, which Dome asserts was ultimately obtained through the claim 1 process, in the form of the Boston IV lens. Dome's PFF. 279-302; Dome's Prop. Concl. Law 52. Specifically, Dome points to the inventions of Novicky and Ellis as evidence that other scientists struggled to create an oxygen permeable contact lens that could be worn comfortably throughout the day. Novicky's polymer had an oxygen permeability of 5 to 8 Dk, Ellis's polymer had an oxygen permeability of 12 to 14 Dk, and both were unsuitable for prolonged daily wear.
Dome's arguments are undermined by the same commensurateness defect that limits its evidence of commercial success. Although the record indicates that the Boston IV lens satisfied the need for a lens suitable for a prolonged wearing day, the record is also clear that other embodiments of claim 1 would fail to satisfy the long-felt need identified by Dome.
Even where evidence of commercial success and other secondary considerations is clear and commensurate with a patent claim, it may be insufficient to outweigh a strong prima facie case of obviousness. See Tokai Corp. v. Easton Enterprises, Inc., 632 F.3d at 1370 ("Even if [the patentee] could establish the required nexus, a highly successful product alone would not overcome the strong showing of obviousness.") (internal quotation omitted); Wyers v. Master Lock Co., 616 F.3d at 1246 (collecting cases). Given that the evidence of secondary considerations in this case is neither compelling nor commensurate with the patent claim, the Court concludes that Dome has not rebutted the Director's strong prima facie showing of obviousness.
For the foregoing reasons, the Court finds that the differences between the process recited in claim 1 of the Neefe Patent and the prior art "are such that the claimed invention as a whole would have been obvious" before September 8, 1980 (the filing date of the Neefe Patent application) "to a person having ordinary skill in the art" of the polymer chemistry of contact lens material. 35 U.S.C. § 103. Accordingly, the decision of the Board of Patent Appeals and Interferences will be upheld. An appropriate Order will issue this same day.
1. U.S. Patent No. 4,306,042 to Neefe, issued December 15, 1981.
2. Curriculum Vitae of Timothy E. Long, Ph.D.
3. POLYMER CHEMISTRY: AN INTRODUCTION (Malcolm P. Stevens, ed., 3d ed. 1999) (Excerpts—title pages and pp. 3-10).
4. CONTACT LENSES (Anthony J. Phillips and Lynne Speedwell, eds., 5th ed. 2007) (Excerpts—title pages and pp. 17-18, 60-64, 66-67, 206).
5. FITTING GUIDE FOR RIGID AND SOFT CONTACT LENSES: A PRACTICAL APPROACH (Harold L. Stein, et al., eds., 4th ed. 2002) (Excerpts—title pages and pp. 167-68, 272).
6. U.S. Patent No. 3,377,371 to Quaal, issued April 9, 1968.
7. U.S. Patent No. 3,808,178 to Gaylord, issued April 30, 1974.
8. U.S. Patent No. 4,120,570 to Gaylord, issued October 17, 1978.
9. U.S. Patent No. 4,152,508 to Ellis et al., issued May 1, 1979.
10. U.S. Patent No. 4,419,505 to Ratkowski et al., issued December 6, 1983.
11. U.S. Patent No. 4,216,303 to Novicky et al., issued August 5, 1980.
12. FITTING GUIDE FOR RIGID AND SOFT CONTACT LENSES: A PRACTICAL APPROACH (Harold L. Stein, et al., eds., 2d ed. 1984) (Excerpts—title pages and p. 238).
14. U.S. Patent No. 4,153,641 to Deichert, issued May 8, 1979.
15. U.S. Patent No. 4,189,546 to Deichert, issued February 19, 1980.
16. Decision of the Board of Patent Appeals and Interferences in Ex parte Neefe, dated July 31, 2007.
17. "Boston Product Information." (Excerpt—BL24, BL31).
18. "Manufacturing of TX-91 Monomer." (BL 1-23).
19. "Synthesis of Methacrylate/Siloxane Monomer," dated November 17, 1978. (BL67-73).
20. Polymer Technology Corporation, PMA 820065—Boston Lens II, Volumes 7, 9 and 11. (Excerpts—BL8325-29, BL8344-48, and BL8478-8512).
21. Polymer Technology Corporation, Special Supplement to PMA 820065—Boston Lens II. (Excerpts—BL8553-57, BL8576-82, and BL8599-8603).
22. Polymer Technology Corporation, Premarket Approval Application for the Boston Equalens. (Excerpts—BL8732-BL8742).
23. "Introducing the Boston Lens IV." (BL4303).
24. Curriculum Vitae of Mark A Melamed, M.D.
25. 3 CUNNINGHAM'S MANUAL OF PRACTICAL ANATOMY (14th ed. 1979). (Excerpt—title pages and p. 152).
26. CONTACT LENS FITTING, A CLINICAL TEXT ATLAS. (Frank J. Weinstock, ed., 1989). (Excerpt—title pages and pp. 11.1-11.16).
27. FITTING GUIDE FOR RIGID AND SOFT CONTACT LENSES: A PRACTICAL APPROACH (Harold L. Stein, et al., eds., 4th ed. 2002) (Excerpt—title pages and pp. 167-68, 271-79).
28. CONTACT LENSES: A GUIDE TO SELECTION, FITTING AND MANAGEMENT OF COMPLICATIONS (Susan Stenson, ed., 1987). (Excerpt—title pages and p. 48).
29. CONTACT LENSES: A TEXTBOOK FOR PRACTITIONER AND STUDENT (Anthony J. Phillips and Janet Stone, 3d ed., 1989). (Excerpt—title pages and p. 761).
30. Letter dated October 17, 1984 from Harold A. Stein, M.D. to Patrick J. Caroline of Polymer Technology Corp.
31. Annual Report for the period of November 1987 to June 1988, Volume II. (Excerpt—BL8282, BL8309).
32. Curriculum Vitae of William J. Benjamin, O.D., Ph.D.
33. Prosecution history of U.S. Patent No. 4,306,042 including references of record therein
34. Reexamination history of U.S. Patent 4,306,042 (Control No. 90/005,090)
1. U.S. Patent No. 2,793,223, issued May 21, 1957.
2. Excerpt of Boston Product Guide (BL4760, BL4776) (1999)
3. Excerpt of Polymer Technology Consultants Reference Manual, Boston Lenses Physical Properties (BL5507, BL5513) (1992)
4. Demonstrative Exhibit—Notebook tabs 1, 2, 3, 9, 10, 11, 12, 13, 16, 18, 19
6. Demonstrative Exhibit Board
1. William J. Benjamin & Quido A. Cappelli, Oxygen Permeability (Dk) of Thirty-Seven Rigid Contact Lens Materials, 79 OPTOMETRY AND VISION SCIENCE 103 (2002).
2. Excerpts from Dr. Long's deposition testimony (pp. 1-2, 94-122).
