Dome Patent, L.P. v. Rea

• Decision Date: 01 July 2014
• Docket Number: Civil Action No. 07–1695 PLF
• Citation: 59 F.Supp.3d 52
• Court: U.S. District Court — District of Columbia
• Parties: Dome Patent, L.P., Plaintiff, v. Teresa Stanek Rea, Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office, Defendant.

59 F.Supp.3d 52

Dome Patent, L.P., Plaintiff

v.Teresa Stanek Rea, Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office, Defendant.¹

Civil Action No. 07–1695 PLF

United States District Court, District of Columbia.

Signed July 1, 2014

Kristin Michelle Whidby, Fried, Frank, Harris, Shriver & Jacobson LLP, Washington, DC, James Wilson Dabney, Stephen S. Rabinowitz, Randy C. Eisensmith, Fried, Frank, Harris, Shriver & Jacobson LLP, New York, NY, for Plaintiff.

Ronald C. Machen, Jr., Daniel F. Van Horn, Mercedeh Momeni, U.S. Attorney's Office, Washington, DC, Scott Charles Weidenfeller, William LaMarca, U.S. Patent and Trademark Office, Alexandria, VA, for Defendant.

OPINION, FINDINGS OF FACT AND CONCLUSIONS OF LAW

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.¹

I. BACKGROUND

A. The Neefe Patent and the Procedural History

The Neefe Patent contains four claims, the first of which is relevant to this action. Claim 1 recites:

A method of making an oxygen permeable material for the manufacture of contact lens [sic] by the synthesization of the monomer 1,1,1–tris(methylsiloxy)methacryloxypropylsilane (a siloxanyl alkyl ester) by the following procedures:

(a) a mixture is prepared having the relationship of one mole of methacryloxypropyltrimethoxysilane with three to forty moles of trimethylchlorosilane;

(b) the mixture is then added to water whose volume is from 3 to 10 times that of the mixture;

(c) agitation is maintained for 30 minutes to 48 hours;

(d) then allow the mixture to separate into layers, remove and filter the upper organic layer;

(e) the unwanted by-product (hexamethyldisiloxane) is then removed by vacuum distillation;

(f) forming an oxygen permeable contact lens material by copolymerizing from 5% to 90% by weight of the 1,1,1 tris(trimethylsiloxy)methacryloxypropyl-silane prepared above; 3% to 90% by weight of an ester of acrylic or methacrylic acid; from 0.5% to 90% by weight of a surface wetting agent, from 0.01% to 90% by weight of an oxygen permeable crosslinking agent selected from the class of multifunctional siloxanyl alkyl esters in the presence of a free radical or a photo initiator.

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.²

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).

Dome timely appealed the examiner's ruling to the Board of Patent Appeals and Interferences (the “Board”). JTX–34 at 1134–35 (Notice of Appeal dated July 12, 2002).³ On July 31, 2007, the Board issued an order affirming the examiner's decision. JTX–34 at 1270–93 (In re Neefe, Appeal 2007–1366).

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.⁴ The Director's expert, Dr. Benjamin, is a Professor of Optometry and Vision Science at the University of Alabama School of Optometry. He is an expert in the measurement of the oxygen permeability of contact lenses and the wettability of rigid contact lenses.⁵

B. The Parties' Positions

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., hydrophilic ). 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 making this polymer, Gaylord began by using a silicone-containing monomer called Tris, which is very oxygen permeable but not wettable (that is, it is hydrophobic ). Gaylord next added other monomers similar to those used in PMMA lenses, which are highly wettable but not oxygen permeable. Gaylord then joined the hydrophobic Tris monomers and the hydrophilic comonomers together, using a hydrophilic cross-linking agent. This material could then be machined into a reasonably usable contact lens. Several other scientists subsequently refined and expanded on Gaylord's invention.

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 and a hydrophobic Tris-type cross-linker.”) (emphasis in original). Dome also attempts to show that the success of a commercial contact lens made using the Neefe process demonstrates the nonobviousness of that process, supporting its patentability.Id. at 1 (describing evidence of “surprising and counter-intuitive results achieved by the method disclosed and claimed in the Neefe Patent” and “evidence of large scale commercial exploitation and use of the method disclosed and claimed in the Neefe Patent”).

The Director disagrees,...