This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
Caliper Life Sciences said last week that it had received a notice of allowance from the US Patent and Trademark Office covering methods of in vivo, non-invasive imaging of light generated from within animals.
The patent is a key part of an intellectual property estate that Caliper gained through its $80 million acquisition of Xenogen last year and covers methods used in the firm’s IVIS Spectrum system, which was launched last fall.
Company officials said this week that they expect to receive the patent within the next month, and have put end users and competitors on notice that other platforms may be employing methods covered by the IP.
The notice of allowance covers US patent application number 11/143,422. Caliper CEO Kevin Hrusovsky said that Xenogen had filed for the patent, which expands the scope of the technology’s underlying patent, about three and a half years ago.
The underlying patent, No. 5,650,135, was issued in 1997 and covers “non-invasive in vivo detection and imaging by administering cells transformed with a light-generating moiety to an immobilized mammalian subject.”
However, after the underlying patent was issued it was the subject of a reexamination process by the USPTO that was initiated by a third party. In order to avoid a lengthy reexamination process, Xenogen decided to voluntarily remove certain claims.
“They didn’t want prior art to create any kind of an issue, so they removed them, and then resubmitted them with the patent office,” Hrusovsky told BioCommerce Week. When Caliper was doing due diligence on its acquisition of Xenogen, Hrusovsky said the firm “felt that these were very important patents for the long-term potential of biophotonic imaging.”
As a result, Xenogen sought two patents on the claims that had been removed from the original filing.
Hrusovsky said that one of the patents was approved earlier this year, but it “wasn’t anywhere near as significant” as the one for which the company received a notice of allowance last week. That first patent, No. 7,198,774, is entitled “Non-invasive localization of a light-emitting conjugate in a mammal.” The patent is assigned to Stanford University but exclusively licensed to Caliper.
According to Caliper, the newly allowed patent covers “non-invasive in vivo detection and imaging by administering to a mammalian subject a conjugate of any biocompatible entity and a light-generating moiety.”
Over the past three years, since Xenogen had removed the claims, other manufacturers have sold platforms “that could, in fact, provide for the methods of running conjugate experimentation,” said Hrusovsky.
“That’s not to say that those instruments can’t do anything but that,” he said. “I think they’re more versatile, so they are probably providing a lot more capability, but the claims that we now have will certainly cover some of the methods that certain end users would be utilizing in those manufacturers’ instruments. That’s our belief.”
He said that despite these other competitors, which include such industry heavyweights as GE Healthcare and Kodak as well as several smaller players, Caliper maintained a roughly 70 percent to 75 percent market share “by having the ability to do bioluminescence, which was [among] our original claims, in a genetically modified living animal, plus having the non-protected ability to do the conjugate research.
“Now, both of those categories will be protected, which is exciting for us,” said Hrusovsky.
“We’ve probably not been as aggressive in making those investments until we knew for sure this was going to be an area that we would have these claims allowed in.”
Caliper’s IVIS Spectrum was launched in the fall and performs both bioluminescence and fluorescent conjugate experimentation. According to Hrusovsky, the platform minimizes autofluorescence, by putting the optics on the bottom of the animal and the light source on the top of the animal, so the optics better pick up the light emitted from the animal.
He noted that many of Caliper’s customers have an interest in conjugate research because it’s more translatable. “There is a lot of excitement for us, not only in the small animal research market, but longer-term we think there are going to be applications of using these types of capabilities in the human,” said Hrusovsky.
For example, he cited colon cancer diagnostics, where false positives can occur if the tumor is on the outside rather than the inside of the colon. “If you could light up true conjugate light sources, you’d have a potentially better opportunity to see that tumor,” he said.
Hrusovsky said that obtaining these patent claims will enable the company to make “significantly more important investments into this area.”
He noted that the firm has been “very collaborative” since Caliper and Zymark merged in 2003, and intends to pursue additional alliances with the technology.
“We think with these claims we can now start to make our own significant investments and know that we will be moving into an area of extreme interest, and also to collaborate then with some of the other important market makers that we see in this landscape,” said Hrusovsky.
He said the patent claims would present Caliper and potential collaborators with opportunities in the fields of biomarker discovery and probe development.
“We’ve probably not been as aggressive in making those investments until we knew for sure this was going to be an area that we would have these claims allowed in,” he said.
Hrusovsky said the firm has a lot of licenses with existing large commercial customers. “The first act that we’re doing is making sure that all of these new claims would be covered under those agreements,” he said. “They will automatically get these rights, so that they can be rewarded for their belief in us and this overall [patent] estate we’ve been amassing.”
He said that the firm would also “educate the rest of the end-user base to these new claims and the potential that they represent for translational experimentation.”
Caliper’s third step, he said, “would be to collaborate with other technology companies that either provide platforms that can achieve some of this [conjugate research] or that have other capabilities around probes and fluorescence that could allow us to create additional reagent sets and capabilities that would allow a more complete solution around translational research.”
Hrusovsky noted that Caliper expects to receive the patent sometime within the next month, after it pays the USPTO the proper fee.