Celsis In Vitro, Inc. v. Cellzdirect, Inc.
83 F. Supp. 3d 774
N.D. Ill.2015Background
- Patent at issue: U.S. Patent No. 7,604,929, which claims a method to produce multi-cryopreserved hepatocytes that remain >70% (or >80% in dependent claims) viable after a second thaw by: (A) density-gradient fractionation to remove nonviable cells, (B) recovering viable cells, and (C) re-cryopreserving them.
- Inventors discovered some hepatocytes can survive multiple freeze–thaw cycles and then applied routine separation (Percoll/Percoll centrifugation) and standard cryopreservation steps to produce pooled products.
- Defendants (LTC) developed an alternate non-infringing elutriation process and moved for summary judgment of patent invalidity under Sections 101 and 112; parties stipulated that if patent valid, LTC infringed certain lots.
- District court previously granted a preliminary injunction (affirmed by the Federal Circuit) and the PTO had reconfirmed the patent in ex parte reexamination, but later Supreme Court precedents changed the legal landscape on subject-matter eligibility.
- At summary judgment the court viewed facts in Celsis’ favor but concluded as a matter of law under the Mayo–Alice framework that the claims are directed to a law of nature and lack an inventive concept; therefore the patent is invalid under Section 101.
Issues
| Issue | Plaintiff's Argument (Celsis) | Defendant's Argument (LTC) | Held |
|---|---|---|---|
| Section 101: Whether claims recite patent-eligible subject matter | Claim is a patentable application: discovery that hepatocytes can be frozen twice + applied steps produce a useful, non-obvious process | Claims merely recite a natural law (cells can survive multiple freezes) and add only routine, conventional steps; so ineligible under Mayo–Alice | Held: Claims are directed to a law of nature and lack an inventive concept; invalid under §101 |
| Section 112(b): Whether claim language is definite given variability in Trypan Blue test | Trypan Blue is industry standard and informs skilled artisans with reasonable certainty | Variability (argued up to ~50%) renders the viability thresholds indefinite | Court declined to decide because §101 invalidity dispositive; noted Celsis likely prevails at summary judgment on §112 issue but did not resolve it |
| Preemption concern: Do claims improperly tie up natural law even if narrow? | Patent is narrowly drawn and does not preempt all ways to separate viable cells (defense of narrow scope) | Even a narrow routine combination of steps that locks a law of nature is impermissible; others could patent other slices, harming future innovation | Held: Narrowness does not save the claims; preemption risk and Mayo–Alice analysis support invalidity |
| Effect of conventional steps / novelty | Inventors added an inventive step by applying density-gradient fractionation and specifying viability thresholds | Those steps were well-known, routine, and did not transform the natural law into patent-eligible subject matter | Held: Addition of conventional post-solution activity insufficient to supply inventive concept |
Key Cases Cited
- Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (articulates two-step test for §101 eligibility and emphasizes search for an inventive concept)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (held steps that merely apply a law of nature using routine activity are not patent-eligible)
- Diamond v. Diehr, 450 U.S. 175 (1981) (process that applies a mathematical formula with inventive application can be patent-eligible)
- Parker v. Flook, 437 U.S. 584 (1978) (holding that claiming a mathematical algorithm plus routine steps can be unpatentable)
- Bilski v. Kappos, 561 U.S. 593 (2010) (confirms exclusion of abstract ideas, laws of nature, and natural phenomena from patentability)
- Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014) (defines definiteness requirement under §112 as informing skilled artisans of claim scope with reasonable certainty)