Saffran v. J&J – When Defining Equals Disclaiming

A guest post from Theresa Stadheim of Schwegman Lundberg & Woessner, P.A.

In Bruce N. Saffran, M.D., Ph.D., v. Johnson & Johnson and Cordis Corporation, Appeal No. 2012-1043 (Fed. Cir. April 4, 2013, decision by Lourie), the Federal Circuit reversed an Eastern District of Texas decision and held that the Eastern District of Texas erroneously construed claims of U.S. Patent No. 5,653,760 (“the ‘760 patent”).

The ‘760 patent discloses a method for treating complex bone fractures that used a “single, flexible, minimally porous sheet.” ‘760 patent at col. 7, lines 34-36.  The alleged infringing device was a stent comprised of a mesh with a microscopic layer of polymer coating each strut of the stent.

One of the issues on appeal was the district court’s construction of the term “device.”

The court concluded that the statements during prosecution of the ‘760 patent limited “device” to a continuous sheet. The court noted that, during prosecution, Saffran distinguished prior art references by arguing that “[t]he device used is a sheet rather than a pre formed chamber (Gaskill).” According to the court, by making this statement, Saffran disclaimed devices that were pre-formed chambers, and further limited “device” to sheets only.  The court cited Andersen Corp. for the reasoning that “an applicant’s argument that a prior art reference is distinguishable on a particular ground can serve as a disclaimer of claim scope even if the applicant distinguishes the reference on other grounds as well.” Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1374 (Fed. Cir. 2007)The court further found it important that the examiner agreed with Saffran’s view of the claimed device as a continuous sheet.    

Further, the court cited Phillips in reasoning that Saffran disclaimed claim scope by making an unqualified assertion (“the device used is a sheet”) that extended beyond illuminating “how the inventor understood the invention.” However, Phillips does not support the court’s assertion. The pertinent section of Phillips states: “Nonetheless, the prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be. Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005) (en banc).  This does not support the assertion that, by going beyond a statement of “how the inventor understood the invention,” an applicant can disclaim claim scope during prosecution.  Instead, Phillips merely supports the assertion that a court may use prosecution history to determine the applicant’s interpretation of the meaning of claim terms.

Further, the court found that the specification consistently described the claimed “device” as a sheet, which suggested that the claimed device should be understood as a sheet.   The specification describes the device’s ability to restrain tissue macromolecules near the site of injury as a “cardinal” and “exceedingly important” feature of the invention. ‘760 patent col. 7 lines 38-46 and col. 20 lines 49-51.  In light of this finding, applicants (and their attorneys) should refrain from such statements regarding any element of the claimed invention.

Judge O’Malley concurred in part, but O’Malley disagreed with the majority’s construction of the term “device.  According to O’Malley, the majority did not find the “clear and unambiguous disclaimer of scope in the prosecution history” required by Storage Tech to reach a finding of prosecution disclaimer.  Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 833 (Fed. Cir. 2003).  O’Malley stated that Phillips held that patent prosecution history was less important for claim construction, and that the majority gave too much weight to patent prosecution history than that which should have been given under Phillips.  However, even aside from O’Malley’s interpretation of Phillips regarding the importance of prosecution history in claim construction, O’Malley did not agree with the majority that Saffran limited “devices” to “sheets,” in the prosecution history.  According to O’Malley, Saffran’s statements regarding Gaskill were only attempts to show that Gaskill was not even within the scope of the ‘760 claims.  O’Malley opined that it would not have made sense for Saffran to disclaim several non-sheet embodiments that had nothing to do with Gaskill. Therefore, according to O’Malley, Saffran did not disclaim non-sheet device embodiments in the prosecution history.

Assuming O’Malley was correct regarding Saffran’s intent, Saffran could have still overcome Gaskill by stating that “the device is not a pre-formed chamber,” rather than defining the device as a sheet.  A lesson we can learn from this is to state the bare minimum to overcome the references in prosecution, rather than making additional affirmative statements such as the “[t]he device…is a sheet.”

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