In its Final Written Decision, the Board concluded that Petitioner has shown by a preponderance of the evidence that claims 1-4 of the ’609 patent are unpatentable.
The Board stated that the ’609 patent is “directed to a method and apparatus for obtaining trans-epithelial specimens of body surfaces using a non-lacerating technique with retractable tools, such as a brush used with endoscopes.” A brush biopsy penetrates the surface of the epithelium by dislodging cells and collects those cells.
In the Board’s Decision on Institution, it did not agree with Petitioner’s challenges that a few phrases of claim 1 of the ’609 patent were ambiguous or indefinite. Petitioner requested reconsideration of its claim constructions. The Board stated that Petitioner’s request was not in the form of a timely request for reconsideration under 37 C.F.R. § 42.71(d) and that the request did not contain an explanation of how the Board’s construction was in error. Thus, the Board adopted the claim constructions from its Decision on Institution. The Board noted, however, that claim 1 was preliminarily interpreted as requiring collection of a specimen of tissue “below the surface layer of the epithelium.” The Board noted, however, that claim 1 is to be interpreted as collecting tissue “located below the surface (versus the surface layer) of the epithelium.”
Turning to evidentiary concerns, Petitioner asserted that the Parasher brush is the device used in the Parasher Article, which Petitioner asserts against the ’609 patent. Petitioner argued that the Parasher Article utilized a brush having semi-rigid and rough bristles made from a Velcro pad. The Board determined that Petitioner did not explain the relevance of this information by pointing out that the Parasher brush includes these features. Thus, the Board afforded no weight to the Parasher Article.
Next, the Board stated that the deposition testimony of Dr. Kahaleh was unpersuasive. Petitioner argued, relying upon the testimony of Dr. Kahaleh, that a biopsy specimen would necessarily include cells from epithelial tissue, basement membrane, and submucosa. The Board disagreed because Dr. Kahaleh utilized the term biopsy in the context of a sample taken using a biopsy forceps. The term brushing was used to refer to a sample taken by a brush. The Board noted that Dr. Kahaleh did not review Parasher before making his statement. Thus, the Board assigned little weight to Dr. Kahaleh’s testimony.
Patent Owner argued that Dr. Kahaleh is not an expert qualified to testify as to what constitutes a biopsy. The Board disagreed, noting that Patent Owner did not request a motion to exclude the testimony and that the claims deal with obtaining a specimen with an endoscope, for which Dr. Kahaleh has expertise.
Petitioner alleged that Parasher anticipated claims 1-4 of the ’609 patent. Patent Owner argued that Parasher fails to disclose all of the claimed features because Parasher does not disclose obtaining a specimen that includes tissue from below the surface of the epithelium. The Board noted that Patent Owner’s argument does not comport with the properly construed claim language (e.g., below the surface). According to the Board, Parasher discloses collecting “scrapings of tissues,” among other similar disclosures, which one of ordinary skill in the art would have understood to mean obtaining cells large enough to be visible to the naked eye. The Board determined that Patent Owner’s expert stated that Parasher’s device could obtain a specimen that included submucosa. Also, the Board interpreted the testimony of Patent Owner’s expert as meaning that Parasher’s brush could dislodge cells from below the surface of the epithelium. Thus, the Board concluded that Petitioner has established by the preponderance of the evidence that Parasher’s brush obtains a specimen by dislodging cells from below the exterior boundary of the epithelium.
Petitioner also challenged claims 3 and 4 as obvious over Parasher and Eisen. Petitioner alleged that Eisen discloses a brush that obtains samples that are the functional equivalent of tissue samples taken by laceration. Patent Owner argued that the Petitioner relies upon improper hindsight analysis. The Board agreed with Petitioner’s reasoning for the combination of Eisen and Parasher. Thus, Petitioner had demonstrated by a preponderance of the evidence that claims 3 and 4 are unpatentable over Parasher and Eisen.
U.S. ENDOSCOPY GROUP, INC. v. CDX DIAGNOSTICS, INC., IPR2014-00639
Paper 27: Final Written Decision
Dated: September 14, 2015
Before: Phillip J. Kauffman, Scott A. Daniels, and Barry L. Grossman
Written by: Kauffman
Related proceedings: CDx Diagnostics, Inc. v. U.S. Endoscopy Grp., Inc., Case No. 1:13-cv-5669-NSR (S.D.N.Y.); IPR2014-00641 (based on U.S. Pat. No. 7,004,913, which is a continuation of the ’609 patent)