Bruce Saffran v. Johnson & Johnson
2013 WL 1338910, 712 F.3d 549, 106 U.S.P.Q. 2d (BNA) 1274 (2013)
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Rule of Law:
An inventor's clear and unambiguous statements to the patent office distinguishing prior art can act as a disclaimer that limits the scope of a claim term. Additionally, a means-plus-function claim limitation is construed to cover only the corresponding structures specifically disclosed in the specification and clearly linked to the recited function.
Facts:
- Dr. Bruce Saffran is the owner of U.S. Patent 5,653,760 ('760 patent) for a medical device and method for treating injured tissue.
- The patent describes a 'single, flexible minimally porous sheet' that can be wrapped around an injury, such as a bone fracture or a vascular stent, to trap healing macromolecules at the site.
- The patent also discloses that a 'treating material' (e.g., a drug) can be affixed to one surface of the sheet for directional release toward the tissue.
- The '760 patent specifies that this treating material is attached to the sheet via a 'hydrolyzable chemical bond,' which breaks down in the presence of water to release the material at a steady rate.
- Cordis Corporation manufactures and sells the Cypher®, a drug-eluting vascular stent.
- The Cypher® stent consists of a metallic open mesh structure, where each strut is coated with a polymer layer containing the drug sirolimus.
- The drug sirolimus is not attached via chemical bonds but is physically mixed into the polymer coating and diffuses out over time.
- The Cypher® stent has open holes between its coated struts and is not covered by a continuous, unbroken sheet.
Procedural Posture:
- Dr. Saffran filed a patent infringement lawsuit against Cordis Corporation in the U.S. District Court for the Eastern District of Texas (a trial court).
- The district court held a Markman hearing and construed the disputed claim terms, finding 'device' to be non-limiting preamble language and the structure for the 'release means' to be 'chemical bonds and linkages.'
- A jury trial was held, resulting in a verdict that Cordis willfully infringed the '760 patent and an award of $482 million in damages to Saffran.
- Cordis filed a post-trial motion for judgment as a matter of law (JMOL).
- The district court denied the JMOL on infringement but granted it on the issue of willfulness, entering a final judgment against Cordis for approximately $593 million, including prejudgment interest.
- Cordis (appellant) appealed the final judgment to the U.S. Court of Appeals for the Federal Circuit, with Saffran as the appellee.
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Issue:
Does a patentee's repeated statement during prosecution that 'the device used is a sheet' limit the claim term 'device' to a continuous sheet, and does the specification's exclusive description of hydrolyzable bonds for a 'means for release' of a treating material limit that means-plus-function element's corresponding structure to hydrolyzable bonds?
Opinions:
Majority - Lourie
Yes. The district court's claim construction was erroneous. A patentee's unqualified assertion during prosecution that 'the device used is a sheet' serves as a clear and unambiguous disavowal of claim scope, thereby limiting the term 'device' to a continuous sheet that excludes open-mesh stents. Furthermore, the 'release means' limitation is a means-plus-function claim governed by 35 U.S.C. § 112, ¶ 6. The only corresponding structure clearly linked in the specification to the function of directional release is a 'hydrolyzable bond.' Scattered, generic references to 'chemical bonds' are insufficient to broaden the scope of disclosed structures. Under these correct constructions, Cordis's Cypher® stent does not infringe because it is not a continuous sheet and does not use hydrolyzable bonds to release its drug.
Concurring - Moore
Yes, but for a more limited reason. The majority is correct that Saffran's prosecution history statements created a clear disclaimer, limiting the term 'device' to a 'sheet' and mandating a reversal on non-infringement. However, the district court's construction of the 'release means' was correct; the specification sufficiently links the function to the broader structure of 'chemical bonds and linkages.' The majority's narrower construction of the 'release means' is unnecessary dicta because the 'device' construction fully resolves the case.
Concurring - O'Malley
Yes, but for a different reason. I agree with the majority's construction of the 'release means' limitation, which is governed by the narrow disclosure requirements of means-plus-function claims and is sufficient on its own to find non-infringement. However, I disagree with the construction of the term 'device.' Saffran’s statements during prosecution were not a clear and unambiguous disclaimer of all non-sheet embodiments, especially when read in the context of distinguishing a specific prior art reference. The written description discloses numerous embodiments that are not sheets, and the claims should not be confined to a single one.
Analysis:
This case serves as a critical lesson in patent law regarding the doctrines of prosecution history disclaimer and means-plus-function claim construction. It underscores that an inventor's arguments to the Patent and Trademark Office can permanently surrender claim scope, even if the patent's text might suggest broader coverage. The decision also reinforces the strict quid pro quo of means-plus-function claiming: an inventor may use functional language at the price of limiting the claim's scope to only those specific structures expressly identified in the specification as performing the function. This holding pressures patentees to be precise in their specification and circumspect in their arguments to patent examiners.
