In Eye Therapeutics, LLC, v. Slayback Pharma, LLC., Appeal no. 2023-2173, (Fed. Cir., June 30, 2025), a panel of Judges Scarisi, Stoll and Tramto reversed a Board decision that the claims of U.S. Pat. No. 8,293,742 were invalid. Claim 1 of the ‘742 patent reads
- [“CEO”] administering brimonidine [“brim”] to a patient having an ocular condition wherein brim is present at a concentration between about 0.0l% by volume and about 0.05% by volume.
Brim is a vasodilator that reduces eye redness. As filed, the claimed method was one “comprising” brim. The comprising of method claim left the claim open to the inclusion of other active ingredients. The Examiner rejected the claims as anticipated by Dean, U.S. Pat. No. 6,242,442 that disclosed a method of administering a composition comprising brim and brinzolamide [“brin”]. Brin is used to treat glaucoma. Eye Therapeutics [“ET”] amended the claims to recite the “semi-open-ended” or “partially closed”, preamble “consisting essentially of” [“CEO”]. It argued and the Examiner agreed that the amended claims were not anticipated because the claimed method does not require the use of any other active ingredients.
The Board reversed, relying on the typical meaning of CEO, that it leaves the claim open to unlisted ingredients that do not materially affect the basic and novel properties of the invention. The Board reasoned that to read the prosecution history to prohibit the use of any other active ingredients would construe the semi-open-ended transition phrase CEO to have the same scope as the closed transition phrase “consisting of”.
The panel disagreed, but went beyond the Examiner’s rationale that the claims distinguished Dean because they did not require the use of any other actives. ET essentially threw a Hail Mary argument that the panel caught for their rationale:
“ET contends the prosecution history supports an atypical meaning of CEO, as the applicant ‘expressly argued that the amended claims preclude the use of other active ingredients and that a basic and novel property of the invention is the administration of brim without other therapeutic drugs. We agree with ET that the prosecution history informs an atypical meaning of CEO in the 742 patent.” [emp. Added].
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“ Given ET’s arguments distinguishing Dean and definitional use of ‘i.e.’ to equate its claimed ‘methods CEO administering brim’ with methods that do not include administering other active agents, the appropriate interpretation of ET’s representation that the claimed methods ‘do not require’ agents other than brim is that the claimed methods preclude the use of such agents.”
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“Under the appropriate construction of CEO , the claimed methods exclude compositions that contain active agents other than brim, undermining the Board’s conclusion.”
The Board had agreed with Slayback that CEO would effectively be converted into “consisting of”, and I can’t see why that isn’t so. If CEO is read to exclude other actives, it is difficult to see what’s left, except for inert carriers and other adjunct agents, and they would be permissible under the traditional or the enhanced CEO.