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USPTO Rejects Life Tech's Thermal Cycler Patent in Initial Ruling

NEW YORK (GenomeWeb News) – The US Patent and Trademark Office has rejected all 12 claims in a key US patent related to real-time PCR thermal cycler technology that is assigned to Life Technologies' Applied Biosystems subsidiary.

The European Patent Office, meantime, last week issued a decision to maintain the European counterpart of the patent in an "amended form."

The US patent, No. 6,814,934, and titled, "Instrument for monitoring nucleic acid amplification," was granted on Nov. 9, 2004 to inventor Russ Higuchi and assigned to Applied Biosystems.

In a "non-final action" issued last month, the USPTO rejected the claims of the patent because they are "not patentably distinct" from those of another Higuchi invention that was awarded a patent in 2001 — US Patent No. 6,171,785, entitled "Methods and devices for hemogeneous nucleic acid amplification and detector," and assigned to Roche Molecular Systems.

In an "obvious-type double patenting" rejection, the USPTO essentially determined that the '785 patent, which covers methods for real-time PCR, presumes the existence of the thermal cycler instrument that is described in the '934 patent.

"Although the conflicting claims are not identical, they are not patentably distinct from each other because the conflicting claims within the '785 patent require a device with detector and thermal cycler, particularly where the container vessels are operably linked" to a device. "Such linkage necessarily provides an instrument or system in which the measurement or detection of fluorescence occurs while amplification is in progress without opening the container or vessel," the USPTO added.

"Thus, '785 patented claims 1-22 render obvious claims 1-12 of the '934 patent under re-examination."

The re-examination request was filed in March 2008 by a third-party requestor called Troll Busters, an IP firm that works on behalf of its clients to secure freedom to operate against patents that it considers to be invalid or overly broad.

Last month's rejection was actually the second non-final action that the USPTO issued in this case. The first, issued in January 2009, rejected all 12 claims based on lack of novelty, noting that they were "anticipated" by three other patents, including US No. 5,210,015, entitled "Homogeneous assay system using the nuclease activity of a nucleic acid polymerase" and assigned to Roche.

"A second non-final office action in a re-examination is highly unusual," Jeff Oster, a Troll Busters founder, told PCR Insider. "In some respects, [Life Technologies] is lucky to get a second non-final office action to improve upon their prior weak response."

Life Technologies will have two months to respond to the latest claims rejection.

Vern Norviel, an IP attorney with Wilson Sonsini Goodrich & Rosati who is familiar with the case but does not represent any of the parties involved, noted that the non-final action means that it's still "very early in the ballgame here. The football analogy would be that it's the first quarter and they're down seven-zip."

Norviel added that double-patenting rejections are "extremely common," but that in most cases both patents are owned by the same party.

In this case, the finding is "unusual" since one patent is owned by Roche and the other by ABI — a result of a longstanding agreement between the two firms to split up the PCR patent estate that originated at Cetus, which was eventually acquired by Roche.
"What is required in a double patenting rejection is not normally a big deal. They say you will agree to have the same patents owned by the same party. But here it's a big deal because in fact the two patents are not owned by the same party. The other one is owned by Roche. So they have to figure out how to deal with that," Norviel said.

Norviel said that Life Technologies could try to narrow the claims of the patent or could "just argue" its case. "We'll have to see what they decide to do."

If the USPTO's decision stands, licensees "may not have to pay a patent tax" to Life Technologies going forward.

Oster said that in anticipation of this scenario, Troll Busters has already raised an undisclosed amount of financing to support an antitrust class-action lawsuit against Life Technologies to "recover the improper royalty and license payments" made for this IP.

He noted that it will likely be difficult for Life Technologies to argue against the most recent rejection without contradicting claims it has made in its "prior extensive file history."

A more comprehensive version of this article is available on GenomeWeb Daily News' sister publication PCR Insider.