Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the story, but not the apocrypha, is set forth in Evan Schwartz's book The Last Lone Inventor). In this aspect of the tale, Farnsworth's brother-in-law, wanting to help but knowing nothing about electronics, learned to blow glass television tubes which he realized were necessary components of Farnsworth's invention. This story comes to mind in a recent nonprecedential Federal Circuit decision regarding methods for isolating DNA from biological samples (such as sputum), found not to be infringed in DNA Genotek Inc. v. Spectrum Solutions LLC.
The case arose over U.S. Patent No. 10,619,187 that claimed a device for "preserving nucleic acids at room temperature for extended periods of time and for simplifying the isolation of nucleic acids" according to the opinion. Claim 1 is set forth in the opinion as being representative:
A device for receiving and preserving nucleic acid in a biological sample, said device comprising:
one or more walls defining a containment vessel having a top having an opening, and a closed bottom having a sample receiving area for holding said biological sample, said opening for receiving a liquid sample and for sealably receiving a sealing cap, said top having an opening for receiving a biological sample from the mouth of a user and further comprising at least one marking on said one or more walls which corresponds to a fluid volume in the sample receiving area;
a reagent compartment having a barrier, said barrier sealing and containing reagents in said reagent compartment and capable of disestablishment to release said reagents into the sample receiving area;
reagents in the reagent compartment for preserving nucleic acids potentially present in the sample wherein said reagents comprise a denaturing agent, a chelator and a buffer agent; and,
the sealing cap, whereby the device is configured such that, when sealably closing said opening with said sealing cap, the barrier mechanically disestablishes to release said reagents to form a mixture of reagents and said biological sample wherein said buffering agent maintains a pH of said mixture equal to or above 5.0 to preserve nucleic acids potentially present in the sample.
As explained in the opinion, the device contains a first region for collecting a biological sample and a second region containing reagents for preserving the nucleic acid in the sample, with a barrier between the two regions; the device further comprises means for "disturbing the integrity" of the barrier so that the reagents in the second region and the biological sample is mixed. Said second region also contains reagents for disrupting cells in the sample, "liberating" nucleic acids, solubilizing the lipid components, stripping [proteins] from DNA and digesting proteins therein," wherein the liberated nucleic acid is stably preserved at room temperature for later analysis. Benefits of the claimed devices and methods for using them include eliminating the need for refrigeration between biological source and clinical or analytical laboratories.
Genotek sued Spectrum for infringement by the latter company's SDNA home saliva-collection kit for providing COVID-19 PCR testing. The District Court granted Spectrum summary judgment of non-infringement based, according to the opinion, on construction of the term "reagent compartment." This appeal followed.
The Federal Circuit affirmed, in an opinion by Judge Rodney Gillstrap,* sitting by designation, joined by Judges Lourie and Hughes. The opinion focused on the District Court's construction of the term "reagent compartment" to mean "a region or section of the containment vessel" and that the '187 patent specification provided "clear guidance" regarding the location of that compartment in the device. Specifically, the District Court construed the location of the reagent compartment to be within the containment vessel of the device. This construction was supported by the prosecution history and the record of an inter partes review (IPR) proceeding in which the '187 patent was involved, according to the opinion. In particular, the District Court held and the Federal Circuit affirmed that Genotek had intentionally deleted "any explicit disclosure of the reagent compartment being in the cap/lid," which evinced "a clear intent to limit the final scope of the invention to a device with the reagent compartment in the containment vessel."
Genotek argued on appeal that the District Court erred in its construction by importing limitations from the specification into the claims and that the plain language of the claims contained no limits on the location of the reagent compartment. The Federal Circuit disagreed, citing several portions of the specification that consistently supported the District Court's construction and that these portions described the invention "as a whole" and not merely preferred embodiments, citing Regents of Univ. of Minnesota v. AGA Med. Corp., 717 F.3d 929, 936 (Fed. Cir. 2013), for the principle that "[w]hen a patent thus describes the features of the 'present invention' as a whole, this description limits the scope of the invention."
Equally unavailing was Genotek's argument that a provisional application from which the '187 patent claimed priority (and which was incorporated by reference) disclosed an embodiment where the reagent compartment was in the cap. The panel found support in the prosecution history for the District Court's construction excluding the cap location for the reagent compartment. According to the opinion, "[w]hen 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." Such deletions have been held to "contribute[ to] understanding . . . the intended scope of the final application," citing MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1369 (Fed. Cir. 2017), and thus the Federal Circuit agreed with the District Court that the properly construed claims of the '187 patent did not include embodiments where the reagent compartment was in the cap or lid.
Finally, Genotek objected to the District Court relying on distinctions between the device claimed in the '187 patent and prior art patents having a reagent compartment in the lid on the grounds that those statements were made with regard to preferred embodiments of the invention claimed in the '187 patent and not the invention as described a whole. The panel noted that these statements were not dispositive but also understood the District Court's consideration of them as permissively "informing the district court's construction" of the claims to the device.
On these bases, the Federal Circuit affirmed the District Court's grant of summary judgment for Spectrum that their SDNA devices did not infringe the asserted claims of the '187 patent.
*Chief Judge of the U.S. District Court for the Eastern District of Texas.
DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)
Nonprecedential disposition
Panel: Circuit Judges Lourie and Hughes, and Chief District Judge Gilstrap
Opinion by Chief District Judge Gilstrap
[View source.]
