Nantkwest, Inc. v. Lee
686 F. App'x 864
| Fed. Cir. | 2017Background
- NantKwest appealed the district court’s grant of summary judgment holding claims 20, 26, and 27 of U.S. Patent Application No. 10/008,955 obvious; the Board and PTO Examiner had rejected the same claims as obvious over prior art.
- The claimed method: in vivo treatment of cancer in a mammal by administering the NK-92 cell line (ATCC CRL-2407); dependent claims specified intravenous human administration and co-administration of a cytokine.
- Key prior art: Santoli (discloses in vivo adoptive immunotherapy using a T-cell line, TALL-104) and Gong (discloses in vitro high cytolytic activity of NK-92 against tumor cells); Yan and other contemporaneous studies compared NK-92 and TALL-104 and discussed clinical applicability.
- PTO and Board found motivation to combine Santoli and Gong (substitute NK-92 for TALL-104) and a reasonable expectation of success based on similar, non-MHC-restricted cytolytic mechanisms and favorable in vitro data for NK-92.
- NantKwest submitted new expert evidence and additional references in the §145 district-court action arguing unpredictability of in vitro→in vivo extrapolation and teaching away; the district court nevertheless granted summary judgment for the PTO; the Federal Circuit affirmed.
Issues
| Issue | Plaintiff's Argument (NantKwest) | Defendant's Argument (USPTO) | Held |
|---|---|---|---|
| Whether claims were obvious over Santoli + Gong | Prior art in vitro NK-92 data did not give a reasonable expectation of in vivo success; skilled artisans were cautioned against extrapolating in vitro to in vivo | Santoli taught in vivo use of a cytotoxic cell line and Gong taught NK-92 efficacy; combining was obvious and predictable | Affirmed: obvious to combine; summary judgment proper |
| Proper construction of "treating a cancer" | Claim should require lysis of many cancer cells (not a single cell) | Agreed that "treating a cancer" requires substantial lysis | Court adopted correct construction (many cells) but found PTO case still valid under that construction |
| Whether new §145 evidence created genuine factual disputes | Expert reports and new references (Vujanovic, Yan, Cesano) show unpredictability/teaching away so summary judgment improper | The new evidence does not create material disputes; prior art and comparisons (Yan) point toward combination; expert contradicted by record | New evidence insufficient to create a triable issue; summary judgment stands |
| Secondary considerations (commercial success/unexpected results) | Investment and Phase I trial results show commercial success and unexpected in vivo results | No nexus between investment and claimed invention; clinical results were not unexpected relative to in vitro data | Secondary considerations did not overcome strong prima facie obviousness |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (superseding obviousness standard; "obvious to try" and predictable solutions)
- Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009) (motivation and reasonable expectation of success test for obviousness)
- Kappos v. Hyatt, 566 U.S. 431 (district court §145 may consider new evidence and must make de novo factual findings if material disputes exist)
- In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988) (obviousness does not require absolute predictability of success)
- In re Carroll, 601 F.2d 1184 (C.C.P.A. 1979) (contemporaneous expert skepticism about in vitro→in vivo extrapolation can show teaching away)
- Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (unpredictability does not automatically avoid obviousness where reasonable probability of success exists)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (summary judgment standard: non-movant’s evidence believed; draw all reasonable inferences for non-movant)
- MicroStrategy Inc. v. Business Objects, S.A., 429 F.3d 1344 (Fed. Cir. 2005) (de novo review of district court summary-judgment decisions)