Saffran v. Johnson & Johnson et al.

Presenting divergent opinions about whether a patentee has demonstrated a “clear and unambiguous disavowal” of claim scope through prosecution disclaimer and what constitutes “corresponding structure” in means-plus-function claims, a panel for the U.S. Court of Appeals for the Federal Circuit reversed a nearly $600 million jury award for patent infringement based on alternate constructions of two claim limitations. Saffran v. Johnson & Johnson et al., Case No. 12-1043 (Fed. Cir., Apr.l4, 2013) (Lourie, J.)(Moore, J., concurring-in-part)(O’Malley, J., concurring-in-part). None of the panel members could agree on the construction of the pair of claim limitations in issue. However, each of the concurring judges alternately agreed with one of the district court’s constructions of one of the two limitations. However, affirmance of either of the constructions foreclosed infringement.

Representative claim 1 recited “[A] flexible fixation device for implantation into human or animal tissue…comprising: a layer of flexible material…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.” Representative claim 8 recited “[A] method of treating a damaged tissue to promote repair” using a similar “device” with the same “means for release” included as a limitation. The district court found that “device” was non-limiting preamble language and referred to “a device having the limitations called out by the body of the claim.” Both the Federal Circuit and the district court analyzed the “means for release” term as a means-plus-function limitation under § 112 ¶ 6. The district court held that the function of the claimed “means for release” is “to release a drug preferentially toward the damaged tissue” with the corresponding structure being “chemical bonds and linkages.”

A panel majority found that since the term “device” was found in both the preamble and the body of the claims, the term should properly be construed to mean “continuous sheet,” since the patentee had clearly and unambiguously disavowed a broader claim scope during prosecution by distinguishing prior art on the basis that: “(i) his device is a sheet, and (ii) that his device is not a pre-formed chamber.” Both the plaintiff and Judge O’Malley argued that the patentee had only disclaimed device embodiments with a pre-formed chamber, i.e., the only embodiment disclosed in the prior art. However, the majority found that patentee’s alternative arguments also limited the claims, and that the patentee’s definitive statement that “the device is a sheet” supported prosecution disclaimer. The majority found that the specification’s various embodiments and descriptions of the aim and benefits of the invention supported the “continuous sheet” construction and specifically excluded the defendant’s stent devices having open mesh holes.

A majority also found that that the proper corresponding structure for the claimed “means for release” is “hydrolyzable bonds” because “no non-hydrolyzable bonds are discussed or suggested” in connection with the preferred embodiment of the invention, and the specification distinguished the prior art based on the use of hydrolyzable bonds. The majority explained that “[u]nder § 112, ¶ 6, the question is not what structures a person of ordinary skill in the art would know are capable of performing a given function, but what structures are specifically disclosed and tied to that function in the specification.”

Judge Moore disagreed with the majority that “chemical bonds and linkages” was not a “corresponding structure.” Judge Moore argued that that § 112 ¶ 6 requires only “some link between a generic structural reference and a claimed function.” Judge Moore also criticized the panel majority as “punish[ing] the patentee for providing a detailed description of his preferred embodiment.” Judge Moore also found the panel majority’s construction to be unnecessary due to the resolution of the case based on the “device” construction. On that basis, she characterized the majority’s “means for release” analysis as dicta.