DNA Genotek Inc. v. Spectrum Solutions LLC

Case Summary:

This is an appeal by DNA Genotek Inc. (Genotek) against a district court's summary judgment of non-infringement in favor of Spectrum Solutions LLC (Spectrum). Genotek alleged that Spectrum's SDNA home saliva-collection kit for COVID-19 PCR testing infringed Genotek's U.S. Patent No. 10,619,187 (the ’187 patent). The ’187 patent relates to devices and methods for preserving nucleic acids at room temperature, particularly in biological samples like saliva, and simplifying nucleic acid isolation. The core issue on appeal is the district court's claim construction of the term "reagent compartment" in claim 1 of the ’187 patent. The Federal Circuit affirmed the district court's construction and the summary judgment of non-infringement.

Key Themes and Arguments:

• Claim Construction Dispute: The central point of contention is the meaning of "reagent compartment" in the context of the ’187 patent. Genotek argued that the term should not be limited to a specific location within the device, whereas Spectrum and the district court argued that it is a "region or section of the containment vessel".

• District Court's Construction: The district court construed "reagent compartment" as a "region or section of the containment vessel." This construction was based on the specification of the ’187 patent, the prosecution history, and statements made during Inter Partes Review (IPR) proceedings.

• Genotek's Appeal Arguments: Genotek argued that the district court improperly imported limitations from embodiments and that the claims themselves do not limit the location of the "reagent compartment." They emphasized that the specification passages relied upon by the district court do not explicitly use the term "reagent compartment" and merely describe embodiments. Genotek argued that anything omitted from the provisional application should not be considered disclaimed. Genotek also challenged the relevance of statements made by its counsel during IPR proceedings for a different patent.

• Federal Circuit's Reasoning: The Federal Circuit affirmed the district court's claim construction, finding intrinsic support for the construction in the specification and prosecution history.

• Specification: The Federal Circuit cited the "Summary of the Invention" and "Detailed Description" sections of the ’187 patent, which describe the invention as "a container that has a first region for collecting a biological sample and a second region containing a composition for preserving a nucleic acid" (’187 patent, col. 6, ll. 26–31). The court agreed with the district court that these sections describe the invention as a whole and indicate that the reagent compartment (the second region) is located within the container. "When a patent thus describes the features of the ‘present invention’ as a whole, this description limits the scope of the invention." (Regents of Univ. of Minnesota v. AGA Med. Corp., 717 F.3d 929, 936 (Fed. Cir. 2013))

• Prosecution History: The court noted that the ’187 patent claimed priority from a provisional application (’398 provisional) that included an embodiment with the reagent compartment in the cap. However, when Genotek filed its non-provisional application, it intentionally deleted all references to that embodiment and included only embodiments with the reagent compartment in the container. The Court held that "deletion from the [] provisional application [] contributes understanding of the intended scope of the final application." (MPHJ Tech., 847 F.3d at 1369).

• IPR Statements: The court noted that during IPR proceedings for another Genotek patent, Genotek's counsel distinguished the ’187 patent from prior art that had a reagent compartment in a lid, stating that the two devices are "very different" because "O’Donovan is a pushed fric-tion fit engagement with spikes in a vial and a reagent in a lid,” whereas the ’187 patent “is a rotated screw cap with a ram in the cap and a reagent below a plastic cover in a con-tainer.” The Court held that "Genotek “described the scope of its own invention as being a device where the reagent is contained in the con-tainer,” which is “very different from a device where the reagent is in a lid.”

Key Facts and Quotes:

• Patent in Question: U.S. Patent No. 10,619,187 ("the ’187 patent").

• Patent Title: "Compositions and Methods for Obtaining Nucleic Acids From Sputum."

• Claim 1 (Independent Claim): Describes a device for receiving and preserving nucleic acid in a biological sample, including a "reagent compartment having a barrier".

• Invention Description from Specification: "a container that has a first region for collecting a biological sample and a second region containing a composition for preserving a nucleic acid, a barrier between a first region and a second region that keeps the sample and composition separate, a means for closing the container, and a means for disturbing the integrity of the barrier, such that the composition is capable of contacting the bodily sample."

• Accused Device: Spectrum's SDNA home saliva-collection kit for COVID-19 PCR testing.

• District Court's Construction of "Reagent Compartment": "region or section of the containment vessel".

Outcome:

The Federal Circuit affirmed the district court's claim construction and the grant of summary judgment of non-infringement in favor of Spectrum. This means that Spectrum's device, as it was found to function, does not infringe Genotek's ’187 patent, because the "reagent compartment" must be located inside the "containment vessel".