An Austin Patent Attorney’s Review: SAFFRAN v. JOHNSON & JOHNSON



In this case Johnson & Johnson and Cordis (collectively referred to as Cordis) appeal the final judgment of the district court that was in favor of Saffran holding Cordis liable for infringing Saffrans U.S. patent 5,653,760 on the theory that the district court erred in their claim construction. This case shows how prosecution history can limit the scope of claims even if further embodiments are disclosed in the specification and how means plus function claims will be limited to what is disclosed in the specification. A representative claim and figure of the ‘760 patent are reproduced below:

1. A flexible fixation device for implantation into human or animal tissue to promote healing of a damaged tissue comprising:

a layer of flexible material that is minimally porous to macromolecules, said layer having a first and second major surface, the layer being capable of being shaped in three dimensions by manipulation by human hands,

the first major surface of the layer being adapted to be placed adjacent to a damaged tissue,

the second major surface of the layer being adapted to be placed opposite to the damaged tissue,

the layer having material release means for release of an at least one treating material in a directional manner when said layer is placed adjacent to a damaged tissue,

the device being flexible in three dimensions by manipulation by human hands,

the device being capable of substantially restricting the through passage of at least one type of macromolecule therethrough.

The specification describes the invention as a mechanism for treating bone fractures, where the bone has been shattered into numerous fragments. The specification describes conventional methods of surgical intervention to align the bone fragments and affix a stabilizing device across the practice site to enable new bone to form and unit the fragments during healing, however if the fragments do not heal correctly or aligned correctly there could be permanent damage. The specification describes utilizing single-layered sheets (which may be sprayed on) that serve as a selective barrier that blocks macromolecules and larger particles, such as tissue and cells, but allow smaller molecules to pass. In embodiments, an additional sheet may be utilized to screen molecules according to properties, such as iconic charge or hydrophobicity rather than size. The sheet may be wrapped around a bone as illustrated in the above figure. Because of the invention’s barrier properties injured tissue at the fracture site are restrained and concentrated within the interfragmentary spaces allowing bone fractures to heal correctly. The specification also describes intravascular stents incorporating the disclosed technology.

On October 9, 2007, Saffran filed suit against Cordis alleging infringement of the ‘760 patent alleging that Cordis infringed by making, using, and selling drug-eluting stents as illustrated in the below image.

The district court during a markman hearing construed the term “device” in the claims to mean “a device having the limitations called out by the claims,” and the limitation of “means for release of at least one treating material in a directional manner” as “means for release of chemical bonds and linkages.” At trial the district court held in favor of Saffran, and on this appeal Cordis appeals the district court holdings based on the claim constructions.

Cordis argued that the district court improperly construed the “Device” and means plus function limitations in the claims. Specifically, Cordis argued that during prosecution of the case that Saffran had argued with the examiner that the term “Device” is a continuous sheet and not a preformed chamber, and therefore the term “Device” should not include other alternatives disclosed in the specification. Saffran responded that the prosecution history of the ’760 patent evinces no clear and unambiguous disavowal of the claim score and instead supports a broad reading of the limitation. The court of appeals held that the Saffran’s statements during prosecution limit the term device to a continuous sheet, reasoning that on multiple occasions during prosecution Saffran sought to distinguish prior art by representing that the device used is a sheet rather than a preformed chamber. The court of appeals further held, that a prosecution disclaimer requires “clear and unambiguous disavowal of claim scope StorageTech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 833 (Fed. Cir.2003), but applicants rearely submit affirmative disclaimers along the lines of “I hereby disclaim the following.” during prosecution and need not do so to meet the applicable standard. Given such definitive statements during prosecution, the court of appeals held that the public was entitled to conclude that the “device” limitation is a continuous sheet.

The court of appeals also held that the district court improperly construed the “release means limitation.” Cordis argued that the district court erred in identifying the corresponding structures disclosed in the ‘760 patent and that the district court’s generic construction is overbroad, and should not include “Chemical bonds and linkages” into the claims because the only bond identified in the ‘760 patent is a “hydrolysable bond.” The court of appeals agreed with Cordis, stating that a means plus function claim shall be construed to cover the corresponding structure, material or acts described in the specification, and that the structure disclosed in the specification is the corresponding structure only if the specification or prosecution history clearly links or associated that structure to the function recited in the claim. Because the specification repeatedly describes the linkage between treating material and the sheet as a hydrolysable bond, this is the means-plus-function as the claims should be read.

Based on the newly defined construction of the claims, the court of appeals reversed the district court finding of infringement, and held that Cordis is entitled to a judgment of non-infringement as a matter of law.


1)      How claims are constructed during markman hearings can turn how a case will turn out. This case illustrates just how important it is for claims to be drafted with sufficient details to cover the embodiments that the applicant wishes to cover. In this case, if there were dependent claims that covered different embodiments of a device, then it would be likely that one of the dependent claims may have been infringed upon. Further, this case illustrates how important it is to have a pending application with the USPTO. If Saffran had an active patent they could draft their claims such that Cordis infringed upon the new claims.

2)      This case also shows how prosecution history can limit the scope of claims without limitations being recited in the claims. It is for this reason, that when arguing claimed limitations in an office action it is best to not to discuss limitations that are not recited in the claims. It is better practice to discuss how the cited art does not meet each limitation as currently recited by the claims without discussing other embodiments of the claims. By describing what is not found in the cited art in relation to your claims opposed to discussing how your limitations in view of the specification are different than what is found in the cited art, you will limit the amount of prosecution history estoppel associated with your embodiments. However, with this strategy of attacking cited art, it may be required for more specific claims. Nonetheless, if an applicant limits the scope of their claims via prosecution history estoppel it would be better for those limitations to be included for the outset before losing on a prosecution history estoppel theory in litigation (more costs).

3)      Means plus function claims will always be held to be narrowing to what is described in specific embodiments of the specification. It is for this reason that means plus function limitations will be construed more narrowly then common English terms. Because it is impossible to include all embodiments of a means plus function mechanism in the specification, it is best practice to not include means plus function language in a claim because it will be construed in markman hearings to be much more narrow than the plain English interpretation of a claim term.

By | 2013-04-04T20:20:04+00:00 April 4th, 2013|Patent Attorney Takeaways|Comments Off on An Austin Patent Attorney’s Review: SAFFRAN v. JOHNSON & JOHNSON