Kathleen “Kay” Terry, Esq. (1934-2018)

Posted on June 12, 2018 by Warren Woessner

Warren and Kay in the early 80’s

We should all note and be saddened by the death of Kay Terry, who was a “godmother” to Schwegman, Lundberg & Woessner from our start in 1993, when she was a head of life science patenting and licensing in the Tech Transfer Office at the University of Minnesota. She had held that position since at least 1984, when we took the BarBri course to prepare for the Minnesota Bar Exam. (I had to sit for the MN Bar Exam since I had not been in practice in NYC long enough to waive in.)

It was a good time to build a practice around patenting inventions originating a universities and non-profit institutions, since they were all scrambling to set up tech transfer offices after the passage of the Bayh-Dole Act in 1980, which permitted universities that originated inventions with Government funding to elect title if they filed for patent protection. She would tell me, “I come across like a naïve little old lady, but the licensees end up facing a negotiator who drives a hard bargain.” Continue reading →

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PTO Issues Section 101 Memorandum after Vanda Decision

Posted on June 11, 2018 by Warren Woessner

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

Posted on June 4, 2018 by Warren Woessner

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!

Posted on May 29, 2018 by Warren Woessner

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.”

Continue reading →

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