Lifenet Health v. Lifecell Corporation
837 F.3d 1316
Fed. Cir.2016Background
- LifeNet sued LifeCell for infringement of U.S. Patent No. 6,569,200, which claims "plasticized" soft tissue grafts whose water is replaced by biocompatible plasticizers (e.g., glycerol) and which can be implanted without rehydration.
- The asserted claims require that “one or more plasticizers are not removed from [an] internal matrix of [the] plasticized soft tissue graft prior to transplantation into a human” (the "non-removal limitation").
- LifeCell’s accused grafts are supplied in a plasticizer solution and come with instructions to rinse in saline for at least two minutes before implantation; that rinse removes a significant amount of plasticizer from the graft (LifeCell contended up to ~50%).
- At claim construction the district court held no further construction was necessary for the phrase “not removed,” treating it by its plain meaning and recognizing the claim language expressly refers to removal “from [the] internal matrix.”
- At trial LifeNet’s expert testified the two-minute rinse removes only nonbound plasticizer in gaps/voids, not plasticizer bound to the internal matrix; the jury found infringement, no invalidity, and awarded damages; the district court denied LifeCell’s post-trial JMOL/new trial motions.
- On appeal LifeCell challenged (1) claim construction/O2 Micro error, (2) sufficiency of evidence of infringement and divided-infringement liability, (3) indefiniteness (apparatus vs. method mix), (4) construction of “plasticized soft tissue graft” (requiring dehydration), and (5) anticipation/obviousness (Werner).
Issues
| Issue | Plaintiff's Argument (LifeNet) | Defendant's Argument (LifeCell) | Held |
|---|---|---|---|
| Whether the district court erred by not further construing the non-removal limitation (O2 Micro) | Construction unnecessary; factual question whether rinse removes plasticizer from internal matrix | Court should have clarified that "not removed" means no plasticizer removed from any part of the graft (including gaps/voids) | No O2 Micro error — LifeCell failed to timely seek modified construction; factual dispute for jury whether internal-matrix plasticizer was removed was permissible |
| Whether substantial evidence supports infringement (plasticizer removal) | Expert showed rinse removes only nonbound plasticizer; bound plasticizer in internal matrix remains | Rinse removes substantial plasticizer; jury should have found non-infringement as a matter of law | Substantial evidence supports jury verdict that internal-matrix plasticizer was not removed; JMOL/new trial denied |
| Whether LifeCell can be liable for direct infringement (divided infringement) | The product as sold contains the claimed plasticizer and meets the non-removal limitation absent further user action | Cannot be liable because an independent surgeon performs any final step (preparation/use) and removal status depends on surgeon | Non-removal is a negative property of the product and is present at sale unless removed; direct infringement can be found against LifeCell |
| Whether claims 1–4 are indefinite because they mix apparatus and method (IPXL) | Claims recite a structural property (plasticizer remains) not a separate method step; no impermissible mixing | Non-removal is a method-of-use limitation inserted into apparatus claims, creating indefiniteness | Claims not indefinite: limitation defines a structural/property aspect of the apparatus and does not require later user action |
| Proper construction of “plasticized soft tissue graft” (must be dehydrated/low residual moisture) | Specification uses “dehydrated” but the district court’s construction already requires replacement of free/loosely bound water by plasticizers | Must require substantial dehydration/low residual moisture; accused products have high moisture so no infringement | Court’s construction (replacement of free/loosely bound water with plasticizers; retain orientation/mechanical properties) stands; no dehydration percentage requirement added |
| Anticipation/obviousness over Werner | Werner discloses relevant treatment; therefore claims anticipated or obvious | Werner does not disclose a "plasticized soft tissue graft" as construed (mechanical properties must be similar to native tissue) | Substantial evidence supports that Werner does not disclose "plasticized soft tissue graft" under the construction; anticipation and obviousness rejected |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (claim construction law: subsidiary factual findings reviewed for clear error)
- O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351 (Fed. Cir. 2008) (court must resolve actual claim-scope disputes)
- IPXL Holdings, LLC v. Amazon.com, Inc., 430 F.3d 1377 (Fed. Cir. 2005) (indefiniteness where claims mix apparatus and method causing uncertainty for manufacturers)
- Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293 (Fed. Cir. 2005) (manufacturer not liable for direct infringement when a third party must perform an affirmative step for the claim to be met)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (principles for claim construction)
- Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003) (negative functional language can define structural elements)
- Akamai Techs., Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (divided infringement/attribution principles)
- DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014) (anticipation reviewed for substantial evidence)