On March 26, 2014, ALJ Thomas B. Pender issued Order No. 14 (dated March 18, 2014) denying Respondents’ motion for summary determination of invalidity of U.S. Patent No. RE 44,453 (“the ‘453 patent”) in Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof (Inv. No. 337-TA-890).

By way of background, the investigation is based on a complaint filed by ResMed Corporation, ResMed Incorporated, and ResMed Limited (collectively, “ResMed”) alleging violation of Section 337 by BMC Medical Co., Ltd., 3B Medical, Inc., and 3B Products, L.L.C. (collectively, “Respondents”) in the importation and/or sale of certain sleep-disordered breathing treatment systems and components thereof that infringe one or more claims of various patents.  See ourJuly 22, 2013 and August 20, 2013 posts for more details on ResMed’s complaint and the Notice of Investigation, respectively.

According to the Order, Respondents moved for summary determination on three issues: (1) anticipation based on German patent application DE 199 36 499 A1 to Schatzl (“Schatzl”); (2) anticipation based on a REMstar Heated Humidifier (“REMstar device”); and (3) the priority date for the ‘453 patent. 

The parties dispute whether or not Schatzl discloses a “seal” disposed between a “top cover” and a “base.”  Specifically, ResMed argued that the structure alleged to be a seal in Schatzl is rigid, and thus does not create a “seal” as required by the claim, supporting this position by reference to additional O rings used for sealing in Schatzl.  The Office of Unfair Import Investigations (“OUII”) agreed with ResMed’s interpretation of Schatzl, and noted that expert testimony at the evidentiary hearing may clarify the issue.  Although ALJ Pender noted that Respondents’ arguments that Schatzl discloses a “seal” are “compelling,” he determined that he “cannot find that there is clear and convincing evidence of this fact without considering expert testimony.”

Respondents also argued that the ‘453 patent is anticipated by the REMstar device sold in the United States by at least May, 2001, supported by invoices.  ResMed disputed that this evidence was publicly available, and whether or not the public sale of the REMstar device predated reduction to practice of the claimed invention.  In addition, ResMed disputed that the REMstar device teaches a “retaining mechanism” as recited in the claims.  Although Respondents pointed to two pegs as alleged retaining mechanisms, the ALJ noted that the pegs “may not satisfy the claim limitation,” and did not consider there to be clear and convincing evidence that the REMstar device met this element of the ‘453 claims.

Lastly, in order for the REMstar device to qualify as prior art, Respondents moved for summary determination that the priority date of the ‘453 patent is no earlier than February 14, 2002, alleging that several limitations of the ‘453 patent are missing from the Australian provisional application filed in 2001 and that the earlier conception documents are incomplete.  ResMed countered this argument with an expert declaration identifying the allegedly missing elements in its conception documents.  OUII agreed with ResMed that a genuine issue of material fact exists regarding when the ResMed inventors reduced the invention to practice.  As Respondents offered no counter-evidence, ALJ Pender agreed with ResMed and declined to grant summary determination on this issue.