No Presumed Validity of Contact Lens Patent in Reexam

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By Tony Dutra

Sept. 3 — A patent infringement charge filed 18 years ago may be finally coming to an end with the Federal Circuit's Sept. 3 affirmance that the 34-year-old patent is invalid.

The U.S. Patent and Trademark Office had determined that Dome Patent LP's U.S. Patent No. 4,306,042 on an oxygen permeable contact lens, underlying Bausch + Lomb's Boston IV contact lens, was obvious based on the technology available in 1980, when the patent application was filed.

Dome argued that obviousness needed to be supported by a high level of proof, under the clear and convincing evidence standard. But, the court ruled that the patent had effectively lost the presumption of validity—which would have justified that standard—when the PTO reexamined it.

The presumption, under 35 U.S.C. §282, only applies when an alleged infringer is contesting patent validity after being sued for infringement, the court said.

Reexamination Reviewed Without Presumption

Dome's patent spent nine years in reexamination instigated by an alleged infringer, a process whereby the PTO treats patents as newly filed applications.

The Board of Patent Appeals and Interferences (now named the Patent Trial and Appeal Board) affirmed an examiner's rejection of claim 1 of the '042 patent in July 2007 using the corresponding preponderance of the evidence standard: Is the claim more likely than not obvious in light of prior art disclosures?

A month later, Dome contested the PTO's invalidity decision by filing a civil action under 35 U.S.C. §145 in district court, rather than appeal to the Federal Circuit directly. Dome argued that the presumption of validity comes back in play when the district court reviews obviousness. The company argued that the court should require the PTO to find clear and convincing evidence of invalidity.

Judge Paul L. Friedman of the U.S. District Court for the District of Columbia rejected that argument seven years later. Dome Patent, LP v. Rea, 59 F.Supp.3d 52, 2014 BL 452038 (D.D.C. 2014). 

The Federal Circuit agreed. It said that the presumption of validity in Section 282 applied regarding infringement complaints, but not PTO invalidity findings.

“When the Patent Office institutes ex parte reexamination, it reopens prosecution to determine whether the claimed subject matter should have been allowed in the first place,” the court said. “At that point, there is no need to presume that the Patent Office had ‘done its job' in the previous examination. Accordingly, the presumption of validity is no longer applicable.”

Obviousness Ruling

Whether the presumption of validity would have made a difference in the obviousness analysis in this case is unknowable. However, the PTO delay in reaching a decision in the reexamination mattered, as the office eventually had the U.S. Supreme Court's “expansive and flexible approach” for analyzing obviousness in KSR v. Teleflex (U.S. 2007) as its guide.

Dome had alleged the '042 patent infringement in 1997 against six manufacturers of contact lens materials. One of them, Optical Polymer Research Inc., filed the reexamination request in 1998, but the BPAI did not rule until July 2007.

The obviousness ruling depended in part on whether there was a showing of motivation to combine the earlier lens-making references that the PTO reviewed. Prior to KSR, courts looked for disclosure of the motivation in one of the references. But, as the Federal Circuit said in its ruling, “The Supreme Court has cautioned, however, that an obviousness determination cannot be confined by formalistic rules.”

Dome also argued for nonobviousness on the basis of a secondary consideration—the commercial success of Bausch + Lomb's product.

However, the Federal Circuit said, “Dome’s own expert testified that the commercial success of the Boston IV contact lens was in part due to other economic and commercial factors not related to the allegedly novel aspects of the claimed invention.”

Judge Todd M. Hughes wrote the court's opinion, which was joined by Judges Jimmie V. Reyna and Alvin A. Schall.

James W. Dabney of Hughes Hubbard & Reed LLP, New York, represented Dome. Scott Weidenfeller of the PTO's Office of the Solicitor represented the agency.

To contact the reporter on this story: Tony Dutra in Washington at

To contact the editor responsible for this story: Anandashankar Mazumdar in Washington at

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