Final Written Decision IPR2013-00247

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Takeaway: To show that a claimed feature is critical requires showing that the specific claimed feature achieves unexpected results compared to the generic prior art.

In its Final Written Decision, the Board found that Petitioner proved that claims 1-3 of the ’105 Patent are unpatentable. The ’105 Patent relates to monitoring the level of a substance in a liquid, particularly the level of glucose in blood.

The Board began with claim construction, stating that the terms will be interpreted according to their broadest reasonable construction in light of the specification. In the Decision to Institute, the Board construed the terms “proportion,” “proportional to,” “downstream,” and “substantially unidirectionally.”  The parties did not contest the prior constructions, and they were adopted in this Decision.

The Board then reviewed Petitioner’s argument that claims 1-3 are obvious over Nankai and Schulman. First, the Board addressed the level of skill in the pertinent art, and adopted Patent Owner’s unopposed definition.  The Board then addressed Patent Owner’s arguments in response to Petitioner’s challenge.  First, Patent Owner argued that it would not have been obvious to reposition Nankai’s reference sensor part to be upstream of the working sensor parts because there is criticality in positioning the reference sensor part upstream.  The Board stated that the criticality of a claimed feature may be demonstrated by showing that the specific feature claimed achieves unexpected results compared to the generic prior art, and Patent Owner failed to make such demonstration.  Patent Owner then argued that Nankai simply averages its multiple measurements rather than comparing them to a difference parameter, but the Board found this unpersuasive because Petitioner relies upon Schulman, not Nankai, for disclosing the comparison of multiple measurements to a difference parameter.  Patent Owner next argued that Nankai fails to address the detection of an inadequate size sample, but the Board found this unpersuasive because the claims do not limit the sample size and when considering the rationale for combining references, the problem examined is the general problem confronted by the inventor before the invention was made, not the specific problem solved by the invention.  Patent Owner then argued that Schulman does not disclose a test strip having the claimed structure, but the Board found this unpersuasive because Petitioner does not rely on Schulman for that disclosure.  Patent Owner next argued that Nankai, Schulman, and the ’105 Patent do not use the same “fundamental technique” for measuring glucose oxidase-mediated electrical current.  The Board found this unpersuasive because Patent Owner did not explain its relevance to the combinability of Nankai and Schulman, and the Board disagreed with the assertion.  Finally, Patent Owner argued that there is no evidence supporting a rationale to combine Nankai and Schulman, but the Board found this unpersuasive because Patent Owner did not credibly explain why it would not have been reasonable for one of ordinary skill in the art to have taken away from Schulman the limited teaching that is being relied upon by Petitioner.

The Board then turned to Patent Owner’s evidence of nonobviousness – that Petitioner copied Patent Owner’s test strips – which was not disputed by Petitioner. The Board found that the evidence was not sufficient because Patent Owner only showed that the product was within the scope of a claim and did not show the required nexus between the copying and the claimed subject matter.

Next, the Board reviewed the allegations that claims 1-3 are unpatentable as obvious over Winarta and Schulman. First, Patent Owner argued that electrode W0 is not disclosed by Winarata as being a working sensor part, but the Board found this unpersuasive because Petitioner’s challenge is not premised upon operating W0 in the role of a counter electrode, resistance sensor, or trigger in order to obtain a glucose measurement.  Patent Owner then argued that Winarta does not disclose any external circuit arrangement or calculation method in a device to allow glucose measurement at W0, but the board found this unpersuasive because Winarata does have circuitry for making measurements involving W0.  Next, Patent Owner argued that because Winarata discloses three uses for W0, there would have been no reason for one of ordinary skill in the art to employ it for the undisclosed use of making a glucose measurement, but the Board was not persuaded by this argument because Patent Owner did not explain why three disclosed uses would dissuade one of ordinary skill in the art from a fourth use.  Patent Owner then argued that Winarta is silent as to whether W0 is the same size as W.  The Board found that Patent Owner is correct, but credited Petitioner’s expert’s testimony that it would have been obvious to make them the same size in the course of adapting Schulman’s comparison method to Winarta’s test strip.  Patent Owner next argued that the combination of Winarta and Schulman fails to meet all limitations of the challenged claims, but the Board found this unpersuasive because Patent Owner only addressed the references individually and not in a combination.  The Board then found that once again, Patent Owner’s evidence of secondary considerations was not enough to overcome the obviousness finding.

Pharmatech Solutions, Inc. v. LifeScan Scotland Ltd., IPR2013-00247
Paper 27: Final Written Decision
Dated: August 6, 2014
Patent 7,250,105 B1
Before: Sally C. Medley, Scott E. Kamholz, and Sheridan K. Snedden
Written by: Kamholz