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Roche v. Cepheid

Representative Claim(s)

1. A method for detecting Mycobacterium tuberculosis in a biological sample suspected of containing M. tuberculosis comprising:
(a) subjecting DNA from the biological sample to polymerase chain reaction using a plurality of primers under reaction conditions sufficient to amplify a portion of a M. tuberculosis rpoB gene to produce an amplification product, wherein the plurality of primers comprises at least one primer that hybridizes under hybridizing conditions to the amplified portion of the gene at a site comprising at least one position-specific M. tuberculosis signature nucleotide selected, with reference to FIG. 3 (SEQ D NO:1), from the group consisting
a G at nucleotide position 2312,
a T at nucleotide position 2313,
an A at nucleotide position 2373,
a G at nucleotide position 2374,
an A at nucleotide position 2378,
a G at nucleotide position 2408,
a T at nucleotide position 2409,
an A at nucleotide position 2426,
a G at nucleotide position 2441,
an A at nucleotide position 2456, and
a T at nucleotide position 2465; and
(b) detecting the presence or absence of an amplification product, wherein the presence of an amplification product is indicative of the presence of M. tuberculosis in the biological sample and wherein the absence of the amplification product is indicative of the absence of M. tuberculosis in the biological sample.

17. A primer having 14-50 nucleotides that hybridizes under hybridizing conditions to an M. tuberculosis rpoB gone at a site comprising at least one position-specific M. tuberculosis signature nucleotide selected, with reference to FIG. 3 (SEQ ID NO: 1), from the group consisting of: [the nucleotides and positions recited in claim 1].

Posture:

Appeal from decision of the District Court

Exception Category: Natural Phenomenon

Primer Claims – Claim 17 and its dependents
“It is undisputed that the primers before us have the identical nucleotide sequences as naturally occurring DNA… Nothing in the ’723 patent suggests that the Roche inventors introduced any mutations that would have made the primers’ nucleotide sequences different from those found in nature. Thus, Roche’s primers are indistinguishable from their corresponding nucleotide sequences on the naturally occurring MTB rpoB gene.”

Method Claims – Claim 1 and its dependents
“[T]he plain language of the asserted method claims, viewed in light of the written description, demonstrates that they are directed to naturally occurring phenomena. The method claims disclose a diagnostic test based on the observation that the presence of the eleven position-specific signature nucleotides of the naturally occurring MTB rpoB gene indicates the presence of MTB in a biological sample.”

“Claim 1 establishes that the method claims are directed to a relationship between the eleven naturally occurring position-specific signature nucleotides and the presence of MTB in a sample. In other words, the method claims assert that if an investigator detects a signature nucleotide from a sample, she knows the sample contains MTB. This relationship between the signature nucleotides and MTB is a phenomenon that exists in nature apart from any human action, meaning the method claims are directed to a natural phenomenon, which itself is ineligible for patenting.”

Significantly More: No

Primer Claims – Claim 17 and its dependents
“Roche next argues that its primers can be distinguished from the patent-ineligible primers of BRCA1 because they can hybridize to only one of eleven position specific signature nucleotides on the MTB rpoB gene. [Citation omitted.] This is an Alice/Mayo step two argument: Roche is arguing that the specificity of its primers to the eleven signature nucleotides would ‘transform’ the claimed naturally occurring phenomenon into patent eligible subject matter. But Roche’s emphasis on hybridizing to particular DNA sequences is unavailing. A primer that is otherwise patent-ineligible does not gain subject matter eligibility simply because it can selectively hybridize to a certain position of naturally occurring DNA, because a primer having an identical nucleotide sequence to naturally occurring DNA without further chemical modification is a natural phenomenon. [Citation omitted.] Here, the primers before us have no further chemical modification.”

Method Claims – Claim 1 and its dependents
“We hold that the method claims do not contain an inventive concept that transforms the eleven position-specific signature nucleotides of the MTB rpoB gene into patent-eligible subject matter. PCR amplification of DNA is the main action step of the method claims. … Neither the claims nor the written description of the ’723 patent disclose any ‘new and useful’ improvement to PCR protocols or DNA amplification techniques in general. The detecting step of claim 1 is similarly devoid of an inventive concept because it involves a simple mental determination of the presence of MTB based on the presence or absence of a PCR amplification product.”

“Roche argues that at the time of the invention, it was ‘not routine or conventional to use PCR (or any other genetic test) to detect the presence of MTB in a biological sample’ and ‘unprecedented to perform PCR using the type of primer specified in claims 1 through 13.’ ”

“While it may be true that Roche inventors were the first to use PCR to detect MTB in a biological sample, being the first to discover a previously unknown naturally occurring phenomenon or a law of nature alone is not enough to confer patent eligibility. … [T]he asserted method claims recite standard PCR methods applied to a naturally occurring phenomenon; there is no additional innovation.”

Judge O’Malley concurred
While joining the majority in its holding that based on BRCA1 precedent, the primer claims at issue are ineligible, Judge O’Malley’s concurrence stressed that the holding in the BRCA1 case was too broad based on the limited facts that were at issue. She contrasted the BRCA1 case with the present case, and argues that genuine issues of material fact exist as to the structural and functional differences between the claimed primers and the naturally-occurring sequences on which the primers are based.

“[W]hile I agree with the majority that the broad language of our holding in BRCA1 compels the conclusion that the primer claims in this case are ineligible under 35 U.S.C. § 101, I believe that holding exceeded the confines of the issue raised on appeal and was the result of an underdeveloped record in that case. I believe, accordingly, that we should revisit our conclusion in BRCA1 en banc.”