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August 16, 2018

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Ex Parte Stone: The “Disappearing Doctor” Leaves a Medical Device Behind

I know that Fed. Cir. s 101 decisions are inherently more instructive than PTAB decisions, but PTAB (and district court) s. 101 decisions are like legal potato chips – if you sample one, you just can’t quit. For example, in Ex Parte Stone, Appeal no. 2017-002188 PTAB, May 3, 2018), the Examiner’s rejection of claims to a system for monitoring bladder fullness as directed to a natural product, namely a human, was reversed.
The main claim is deceptively simple:

Claim 1. A system comprising:
a sensor configured to general a signal indicative of mechanical oscillation of a bladder of a patient; and  a processor configured to receive a signal from the sensor, determine the oscillation frequency of the bladder based on the signal, and take a responsive action based on the oscillation frequency.

The specification of Application Serial No. 13/764,911 reads in part:
“The frequency at which the bladder oscillates, e.g. following a non-[voiding] contraction, may be correlated to the bladder fullness level. It is believed that the oscillation frequency of the bladder decreases with bladder fullness.”

The responsive action taken can be therapy, such as electrical nerve stimulation, or it can be the delivery of a notification to a caregiver, that is based on the oscillation frequency. The Examiner rejected the claim, asserting that the “system” could be a “human organism” where its finger could be the “sensor” and its brain could be the “processor.” However, noting that the sensing element and the processor were described as mechano-electrical devices at paras. 68 and 75, the Board agreed with appellants that “[t]he Examiner has not pointed to any description in the Specification or evidence from any other source, to support the position…that the function of the sensor…could be carried out by a human being placing their hand or finger on an area above the bladder in order to sense the oscillation frequency of the bladder.

The Board reversed the rejection as not supported by a preponderance of the evidence. The rejection of a means-plus-function claim was reversed on the basis that the “Examiner has not shown that the claims interpreted under [112, para.6] read on a human organism when properly interpreted.” This is at least a suggestion than the Examiner rejected the claims using the discredited “broadest possible interpretation.”

But wait, there’s more. Note the phase quoted above that the oscillation “may be correlated to the bladder fullness level”. This could well have triggered a natural phenomenon s. 101 rejection but it didn’t. The discovery of an “If A, then B” correlation often dooms claims to diagnostic methods. I credit the prep/pros attorney for NOT writing the claims in this form:

“Claim 1. A method for determining bladder fullness comprising:
(a) determining the oscillation frequency of the bladder and
(b) correlating the frequency of the oscillation to bladder fullness, wherein the oscillation frequency decreases as bladder fullness increases.
Claim 2. The method of claim 1 wherein responsive action is taken based on the oscillation frequency.”

The claim rejections reversed by the Board permitted the “system” claims  to remain in Step 2A of the Mayo/Alice test, because the Examiner argued that the claims read on measuring the frequency by human touch and carrying out the correlation to bladder fullness in the mind.

Things could have turned out very differently if the Board proceeded to step 2B of the Mayo/Alice test and ruled that the dreaded “inventive step” was absent due to the use of conventional sensors and processors to carry out steps (a) and (b). The responsive action can be a notification to the care giver as well as initiation of medical procedures. This decision also indirectly points to the importance of the novelty and non-obviousness of the use of the sensors and processors as recited in the claims. (The claims were also found to be non-obvious over prior art methods of detecting other bladder parameters.) This is the heart of Cleveland Clinic’s petition for writ of cert. to the Supreme Court, and it gets more important to the future of diagnostic claims every day.

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About this Author

Warren Woessner, Registered Patent Attorney, Schwegman Lundberg Law firm
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Warren Woessner is a registered patent attorney and a founding shareholder of Schwegman, Lundberg & Woessner. His practice focuses on chemical patent law, including biotechnology, pharmaceuticals, vaccines, medical treatments, diagnostics, and biofuels and agricultural chemistry, including related opinion and licensing matters.

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