In its Decision, the Board denied institution of inter partes review claims 1-2 and 5-8 of the ’987 patent because Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to claims 1-2 and 5-8. The ’987 patent relates to a method for sorting sperm cells to enrich a population thereof for a particular characteristic such as an X or a Y chromosome. The enriched population is produced by uptake of a dye that results in a mixture of cells with differential fluorescence intensity depending on the sex chromosome present in each sperm cell. A photodetector distinguishes the differential fluorescence of the cells, thereby classifying the cells according to their X or Y content.
The ’987 patent also discloses a conventional flow cytometry apparatus that sorts sperm cells based on their X or Y content. The apparatus produces a stream of droplets, each of which ideally contains a single sperm cell. A pair of electrostatic charged deflector plates sorts and deflects droplets into separate streams, maintaining the segregation of the different populations. The droplet sorter can be replaced or eliminated with a laser to ablate undesired particles in the fluid stream. Thus, the modified apparatus does not depend on physical separation of cells. Undesired cells are ablated and collected in the same container as desired cells.
Petitioner alleged: (1) claims 1-2 and 5-8 are anticipated by Keij, (2) claims 1-2 and 5-8 are obvious in view of Johnson and Keij, (3) claims 1-2, 5, and 7-8 are obvious in view of Johnson and Shapiro, and (4) claim 6 is obvious in view of Johnson, Shapiro, and Keij.
The Board construed the claimed term “enriched population of sperm” as referring to a population in which the ratio of viable sperm cells, having the A or B characteristic, to total viable sperm cells, has been increased as a result of photo-damaging selected cells.
Petitioner argued anticipation by Keij. The Board determined that Keij discloses a cell sorter that ablates cells as an alternative to a droplet sorter. However, Keij does not apply its photo-damage sorter to sperm cells. Petitioner argued that Keij expressly refers to sorting of X or Y chromosome-bearing sperm cells for insemination as an interesting possibility. The Board found that under 35 U.S.C. § 102, Petitioner failed to demonstrate sufficiently that photo-damaging selected sperm cells produce an enriched population of sperm. Keij contains no example of a method of sperm sorting. The Board concluded that Petitioner failed to show a reasonable likelihood of prevailing at trial on anticipation based on Keij with respect to claim 1 and, consequently, claims 2 and 5-8 as well.
Petitioner asserted obviousness of claims 1-2 and 5-8 over the combination of one or more of Johnson, Keij, and/or Shapiro. Petitioner alleged that Keij suggests sorting of X or Y chromosome-bearing sperm cells relying on the statement in Keij that such sorting is an interesting possibility. The Board stated that this is insufficient to show that an ordinary artisan would have reasonably expected that photo-damage sorting would produce the specified enriched population of viable sperm having either the A or B characteristic. Further, Keij states that cell survival is of critical importance in sorting. According to Johnson, increasing sort speed decreases sperm viability. The Board noted that the collection rates of Keij and Shapiro are five and twelve times that of Johnson. Accordingly, the Board concluded that Petitioner did not argue or sufficiently show that one reasonably would have expected extremely delicate cells such as sperm cells to survive the stresses of Keij’s photo-damage sorter. Petitioner, therefore, failed to show a likelihood of prevailing at trial on this record because Petitioner did not establish adequately that one would have reasonably expected success in applying the modified apparatus to obtain an “enriched population of sperm” required by each challenged claim.
ABS Global, Inc. v. Inguran, LLC, IPR2015-00001
Paper 11: Decision Denying Institution of Inter Partes Review
Dated: April 29, 2015
Before: Grace Karaffa Obermann, Michelle R. Osinski, and Susan L. C. Mitchell
Written by: Obermann