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Testing The “Myriad Method Claims” Using The USPTO Interim Guidance – Beyond “M or T”?

In my last post, I discussed the contents of the USPTO’s “Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos.” One of the most intriguing single points for discussion comes at the end of part III of the Notice, before the eight “pro” and “con” factors are listed:

“To date, no court presented with a subject matter eligibility issue, has ever ruled that a method claim that lacked a machine or a transformation was patent-eligible. However, Bilski held open the possibility that some claims that do not meet the “M or T” test might nevertheless be patent eligible.”

Among those courts are the S.D.N.Y. In his decision in Ass’n. for Molecular Pathology v. USTPO et al (the “Myriad case”), Judge Sweet invalidated just such claims. Among them was claim 2 of U.S. Pat. No. 6033857: [shortened by me] A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene…in a tissue sample from said subject with the germline sequence of the wild-type BRAC2 gene, wherein an alteration in the germline sequence of the BRAC2 gene indicates a predisposition to said cancer.”

Claim 1 is more succinct: It is directed to a method for identifying a mutant BRAC2 nucleotide sequence in a suspected mutant BRAC2 allele which comprises comparing the sequence of the suspected mutant sequence with the wild-type [reference] sequence, wherein a difference between them identifies a mutant BRAC2 sequence.

Judge Sweet would have none of this. He distinguished Prometheus as involving actual transformation and stated: “In contrast, the language of the method claims-in-suit and the plain and ordinary meanings of the terms “analyzing’ or ‘comparing’ establish that the method claims-in-suit are directed only to the abstract mental processes of ‘comparing’ or ‘analyzing’ gene sequences.” Judge Sweet refused to read the claims as including the physical transformations associated with sampling and sequencing, but he acknowledged that certain dependant claims – not asserted – contained such “transformative events.” Slip op. at 141-143. However, he concluded: “Even if the challenged method steps were read to include the transformations associated with isolating and sequencing human DNA, these transformations would constitute no more than ‘data-gathering step[s]’ that are not ‘central to the purpose of the claimed process.’” [citing Grams] Slip op. at 145.

These claims are in effect directed to diagnostic assays based on “data mining.” It seems that about every day there is another item of genomic news reporting that a mutation at position x of gene y indicates a predisposition to, if not presence of, some pathology or the ability, or lack thereof, of the subject having the mutation to be helped by a particular drug. This is the foundation of personalized medicine. Pretty soon, most of us will be able to afford to carry the DNA sequences of our individual genomes around on a memory stick. Before a particular treatment or lifestyle change is initiated, the doctor will be able to compare the relevant regions of our genome with reference regions that will let the doctor know if the diagnosis is correct and if the proposed therapy will help. The “testing lab” our DNA data is sent to to will not need to sequence it, and they will already have the reference or benchmark sequences (the “wild-type sequences” of the Myriad claims). They will simply compare the sequences and report the differences they find, and where they are (and probably, what they mean as well). Welcome to the future of medicine.

Claims such as the Myriad process claims do not recite an M or T, but they also do not simply attempt to claim the broad concept that mutations in human DNA indicate presence or propensity for disease (“the concept”). The claims implement the concept in a tangible way, by looking for mutations in a few defined sequences. The performance of the steps is observable and verifiable (presumably, a computer will compare the sequences and identify the specific mutations, if any, that are present. The results had better be verifiable statistically or no one will use the test.)

So how would an Examiner in possession of the Interim Guidance act on the Myriad diagnostic method claims today? The Interim Guidance does disparage method claims based on mental steps, beyond warning against patents on naked concepts. Certainly, the method claims directed to diagnosing a predisposition for breast cancer “describe a particular solution to a problem to be solved” and “Implement the [general] concept in a tangible way.” But what fate for the claims that simply recite identifying a mutant sequence in a BRCA2 gene? Is the “comparing step” enough to avoid the prohibition against “monopoliz[ing] a natural force or patent[ing] a scientific fact?’ For now, you be the judge.


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