PTAB

IPR2022-00146

Slayback Pharma LLC v. Eye Therapies LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Compositions and Methods for Eye Whitening
  • Brief Description: The ’425 patent discloses methods for increasing eye whiteness and reducing redness by administering ophthalmic compositions containing "low concentrations" (defined as below about 0.05% weight by volume) of a selective α-2 adrenergic receptor agonist, preferably brimonidine.

3. Grounds for Unpatentability

Ground 1: Anticipation by ’553 patent - Claims 1-6 are anticipated by the ’553 patent.

  • Prior Art Relied Upon: ’553 patent (Patent 6,294,553).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Example 1 of the ’553 patent expressly disclosed all limitations of the challenged claims. Specifically, the ’553 patent described a clinical trial involving the administration of a 0.03% brimonidine ophthalmic solution to human subjects undergoing radial keratotomy. Petitioner contended that this 0.03% concentration fell squarely within the concentration range recited in independent claim 3 of the ’425 patent ("between about 0.001% to about 0.05%"). Furthermore, Petitioner asserted that reducing the known post-surgical redness (hyperemia) caused by radial keratotomy was an inherent result of administering the brimonidine composition, thereby meeting the method limitation of "reducing redness of an eye." The argument for anticipation of claims with different preambles (e.g., "increasing whiteness") relied on the assertion that reducing redness inherently increases whiteness.

Ground 2: Anticipation by Walters 1991 - Claims 1-6 are anticipated by Walters 1991.

  • Prior Art Relied Upon: Walters 1991 (an abstract from the Association for Research in Vision and Ophthalmology).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Walters 1991 disclosed administering a 0.02% ophthalmic solution of a compound identified as "AGN 190342-LF" to patients with open-angle glaucoma or ocular hypertension. Petitioner provided extensive evidence from other publications (including Timmermans 1980, Chien 1990, and Burke 1995) to argue that a person of ordinary skill in the art (POSA) would have unequivocally understood "AGN 190342-LF" to be brimonidine. The disclosed 0.02% concentration was within the claimed ranges of the ’425 patent. Petitioner argued that administering this known vasoconstrictor to patients inherently reduced eye redness, even if that was not the primary purpose of the study, thus anticipating the method claims.

Ground 3: Obviousness over multiple references - Claims 1-6 are obvious over the ’553 patent in combination with Norden 2002 and other prior art.

  • Prior Art Relied Upon: ’553 patent (Patent 6,294,553), Norden 2002 (a 2002 journal article), ’442 patent (Patent 6,242,442), Alphagan® Label 1998, and Federal Register 1988.
  • Core Argument for this Ground:
    • Prior Art Mapping: The ’553 patent taught using brimonidine to treat ocular inflammation, which includes redness, and disclosed a concentration of 0.03%. Norden 2002 reported that refractive surgeons were already using brimonidine prophylactically to reduce post-operative redness and improve appearance after LASIK surgery. The ’442 patent taught that hyperemia was a known side effect of higher brimonidine concentrations, suggesting that lowering the dose would be advantageous. The Alphagan® label and Federal Register established brimonidine as a known vasoconstrictor used in eye drops.
    • Motivation to Combine: A POSA, knowing from Norden that brimonidine was effective for reducing redness and from the ’442 patent that lower doses could reduce side effects, would be motivated to optimize the concentration for this purpose. The ’553 patent further suggested a range of 0.01% to 0.5% for study. Petitioner argued a POSA would combine these teachings to conduct routine dose-ranging studies to find the lowest effective concentration for redness reduction with minimal side effects, such as the unwanted lowering of intraocular pressure.
    • Expectation of Success: A POSA would have had a high expectation of success because brimonidine was a well-known, potent vasoconstrictor approved for ophthalmic use. Optimizing a dose for a known effect (vasoconstriction to reduce redness) through routine experimentation was a predictable and standard practice in pharmaceutical development.

4. Key Claim Construction Positions

  • "a subject in need thereof": Petitioner argued this term was not limited to subjects with hyperemia from a disease or condition. Based on the patent’s specification, which emphasized improving "cosmetic appearance" and whitening "healthy eyes," Petitioner contended the proper construction included any person, including those with healthy eyes, who desired whiter eyes. This construction was crucial for mapping prior art references like Walters 1991, where patients were treated for glaucoma but would still qualify as subjects in need of cosmetic eye whitening.
  • "about 0.025%": This term appeared as the upper limit in several dependent claims. Petitioner argued that this term must be construed to encompass the 0.03% concentration disclosed in Example 1 of the ’553 patent. The argument was based on the ’425 patent's own disclosure, which characterized concentrations up to "about 0.05%" as "low concentrations" and did not describe the 0.025% limit as critical. Petitioner asserted that a POSA would consider 0.03% to be "about 0.025%" in this context, making the dependent claims anticipated by the ’553 patent.

5. Relief Requested

  • Petitioner requested institution of an IPR and cancellation of claims 1-6 of the ’425 patent as unpatentable under 35 U.S.C. §§ 102(b) and 103(a).