PTO Rules on Pre-issuance Submissions by Third Parties

Posted on July 20, 2012 by Warren Woessner

On July 17th, the USPTO released the rules that will govern the mandate in Section 8 of the AIA that requires the Office to provide for the submission by third parties of patents, published patent applications and other materials that qualify as a “printed publications” to be considered by the Examiner in pending applications. 77 Fed. Reg. 42150 (July 17, 2012). (A copy is found at the end of this post.)

What I initially thought would be one of the less complicated group of rules still required 17 pages of three-column text to explain. The timing provisions are quite generous; submissions must be before the earlier of the mailing date of the notice of allowance or the later of six months after publication or the date of first rejection. The first three items can be submitted without a fee, then it will be $180 per group of ten. The Rules go into effect September 16, 2012 and are retroactive. However, two major areas stood out, both of which may frustrate Examiners, rather than speed the examination process.

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Why Myriad Should Drop Its Appeal

Posted on July 16, 2012 by Warren Woessner

In the Kenny Rogers song, “The Gambler,” Rogers sings “You got to know when to hold ‘em, know when to fold ‘em.” There is still time for Myriad to “fold ‘em” and drop its appeal of the district court decision ruling that the main claims of a group of “BRCA2 patents” are not patent-eligible under s. 101. Remember, this is not AMP’s appeal any more. The Supreme Court vacated the Fed. Cir. decision that held while the claims to isolated DNA sequences and to the use of transgenic BRCA2 cells for drug screening were patentable subject matter, the “diagnostic method claims” to comparing a patient’s BRCA2 sequence to a reference sequence or to analyzing the sequences for differences were simply abstract ideas, and not patent-eligible a la Bilski. The Court remanded the suit to the Fed. Cir. for reconsideration in view of Mayo v. Prometheus, which has nothing to do with composition of matter claims or with Chakrabarty-type “use” claims.

However, Myriad’s legal team seems to want a “win” at any cost, and oral argument is set for Friday. Other commentators including Prof. Hal Wegner, have argued that the “cost” to the ability to advance “personalized medicine” may be high indeed. In ruling all of the “diagnostic claims” patent-ineligible, the Fed. Cir. only spent about five pages of the more than a 100 page opinion discussing these claims. Most of Myriad’s arguments were an attempt to convince the court that, because one of the DNA sequences was necessarily obtained by sampling patient tissue and sequencing its DNA,  that the claims met the M or T test. Judge Lourie dismissed this argument summarily and focused on the claims that only recited “analyzing” or “comparing” the sequences for differences. He mentioned that practical application of the analyzing or comparing steps might describe patentable subject matter, he lost the thread, and did not explain why at least some of the method claims did not meet this standard.

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“In Leukemia Treatment, Glimpses of the Future” of Medicine and IP

Posted on July 9, 2012 by Warren Woessner

A provocative article in the Sunday New York Times recounted how a young cancer researcher, who was diagnosed with acute lymphoblastic leukemia (ALL), and who responded but relapsed twice after receiving chemotherapy and bone marrow transplant, achieved a third remission after his colleagues sequenced all of the RNA of a sample of his leukemic cells and all of the DNA in a normal tissue sample, in hope of finding a genetic mutation that would yield a treatable target.

The results of the DNA sequencing revealed some mutations, but none that could be targeted with known drugs, “[B]ut RNA sequencing revealed that a normal gene, FLT3, was overactive in his leukemia cells.” Overexpression of this gene, which encodes that FLT3 receptor, causes marrow cells to be a magnet for the FLT3 ligand (or “FL”), and “appeared to be driving the growth of his leukemia.” Dr. Wartman, the patient, was given sunitinib, a drug approved for the treatment of stomach and kidney cancer, and is in remission.

Although the story makes all this work sound sui generis, overactive FLT3 comprising various mutations was known to be associated with a subset of ALL patients, as well as in other patients, such as one third of AML patients, and other drugs were known to have at least some ability to  block  FLT3 receptors. See, D. Small et al., ASH Educ. Book, 1, 178 (Jan. 1, 2006). But what if all the work described in the story originated with the Washington University team? What could they patent under the Mayo/Myriad “rules”?

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PTO Guidelines for Process Claims Involving Laws of Nature

Posted on July 8, 2012 by Warren Woessner

On July 3rd, the PTO released 13 pages entitled “2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature.” They are intended as guidance for Examiners who encounter such claims, e.g., in Group 1600, in the setting of a method of medical treatment or a diagnostic method.

The guidelines are an attempt to conform the examination process to the S. Ct.’s decision in Mayo v. Prometheus and set forth a three-part inquiry to determine patent eligibility: 1) Is the claimed invention directed to a process? 2) Is a natural principle – e.g., a naturally occurring relation or correlation a limiting feature of the claim, and 3) Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? “(Is it more than a law of nature + the general instruction to simply “apply it”)? If the answer to the 3 queries is “yes”, “yes”, “no”, the claim is patent ineligible. Number 1 is pretty easy, number 2 is trickier than it appears and number 3 is pretty much stuck in the Twilight Zone.

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