PTO Issues Section 101 Memorandum after Vanda Decision

I have posted twice recently on the Fed. Cir.’s opinion in Vanda Pharms., Inc. v. West-Ward Pharm. Int’l, Ltd., Appeal no. 2016-2107 (Fed. Cir., April 18, 2018). The Fed. Cir. affirmed the district court’s ruling that Vanda’s claims in U.S. Pat. No. 8,586,610 were patent-eligible under s. 101. The claims were directed to a method for treating schizophrenia using Vanda’s iloperidone (ilo). Claim 1 relied on two natural phenomena: (1) Genotyping a patient sample to determine whether or not the patient is a producing enough of enzyme CYP2D6 to be a normal metabolizer of the drug or is a “poor metabolizer” of the drug; and (2) Administering less than 12 mg/day of the drug if patient is a poor metabolizer and at least 12-24 mg/day if the patient is a normal metabolizer, to lower the risk of a cardiac side-effect.

The two laws of nature were that mutations in the CYP2D6 genes can alter their enzymatic activity and that a patient’s CYP2D6 enzymatic activity affects his/her metabolism of the drug. W-W argued – of course – that the dose adjustment step was simply a routine and conventional way to reduce side effects. Continue reading

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Ex Parte Galloway – Berkheimer Meet s. 103 Part II

In Ex parte Galloway, Appeal No. 2017-004696 (PTAB, May 24, 2018), the Board reversed the examiner’s rejections of claims to a method of diagnosing bladder cancer. The method comprised isolating cells from the urine of a subject, dispersing at least 5000 cells on a slide, staining the cells with a labelled binding member [such as an antibody] capable of binding to MCM2 polypeptide, counting the stained cells wherein if the count is at least 50/5000 cells, the subject has bladder cancer [claim was abbreviated to simplify discussion]. Continue reading

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Ex Parte Smith: What We’ve Got Here Is A Failure To Communicate!

In Ex parte Smith, Appeal No. 2016-007565 (PTAB, May 16, 2016), the Board reversed the examiner’s s.101 and 103 rejections of a claim to a modified flavivirus envelop (E) protein comprising a mutated envelop protein, where the unmodified E-To domain comprises a central glycine amino acid and 15 recited points of mutation, “wherein the mutation selectively inhibits the replication of a flavivirus comprising the modified E protein in mammalian cells relative to insect cells.”

For some reason known only to the prosecution history, the examiner rejected this claim on the basis that is was directed to a natural product (and the SPE did not intervene) because “it reads on a fragment of the naturally occurring protein and that the fragment does not appear to be structurally different from the full-length sequence except through cleavage of a peptide bond” and the claim “reads on a product that is not markedly different from a naturally occurring product and is, therefore, directed to patent ineligible subject matter.”

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Ex parte Galloway – Two Correlations are Better than One

Wooden gavelAlthough, somehow, examiners and PTAB Judges are supposed to refrain from considering anticipation or obviousness when evaluating claim elements for the “inventive step” required for patent eligibility, that’s just not possible. The claims in Ex parte Galloway were directed to an assay for prostate cancer that involved identifying prostate cancer cells in a sample and then washing and contacting the same sample with an antibody to a minichromosome maintenance protein (MCM):

40. A method of detecting or determining the presence of prostate cancer cells in a sample of bodily fluid from a subject [comprising]:
(i) isolating cells from said sample [such as urine] to provide a cell sample;
(ii) contacting said cell sample first with a monoclonal antibody or fragment thereof, having an antigen binding domain specific for a prostate antigen [such as PSA];
(iii) washing said cell sample;
(iv) contacting said cell sample from step (iii) with a monoclonal antibody or fragment thereof, having an antigen binding domain specific for a [MCM-2] polypeptide; and
(iv) determining the binding of both of said monoclonal antibodies or fragments thereof, to the cell sample to detect prostate cancer cells in said subject.

The PTAB first considered the obviousness rejection over two pieces of prior art. However, one reference suggests “analysis of prostate epithelial cells shed into seminal fluid” could provide a prostate cancer assay, while the other reference teaches measuring “urinary (body fluid) PSA as a useful marker in diagnosis of prostate cancer.” The Appellant essentially argued that the references were not logically combinable, since the second reference “expressly avoids semen in his urine PSA assays.”

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