Guest Post by Jennifer Johnson
In a previous post, we discussed the recent Federal Circuit decision concluding the claims in U.S. Patent 8,586,610 are not directed to naturally-occurring phenomena. But one overlooked aspect of the claims in the ‘610 patent is the reliance on what might be characterized (by the Patent Office) as conditional language and the impact that the Federal Circuit’s affirmation of the validity of the claims may have on Ex Parte Schulhauser, a precedential decision by the Patent Trial and Appeal Board (PTAB) (Appeal No. 2013-007847 (PTAB April 28, 2016)). Claim 1 at issue in Ex Parte Schulhauser is directed to a method for monitoring cardiac conditions incorporating an implantable medical device in a subject, where the method includes several steps that only need to be performed if certain conditions are met. Claim 1 recites, in part:
…comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event;
triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria;
determining the current activity level of the subject from the activity level data if the electrocardiac signal data is within the threshold electrocardiac criteria.
In determining whether claim 1 was obvious over the cited references, the board first explained its rationale regarding the broadest reasonable interpretation of claim 1:
Due to the language in the "triggering" and "determining" steps, logically, the "triggering" and "determining" steps do not need to be performed, after the "comparing" step if the condition precedent recited in each step is not met. More specifically, the "triggering" and "determining" steps of this claim are mutually exclusive. If the electrocardiac signal data is not within the threshold electrocardiac criteria, then an alarm is triggered and the remaining method steps need not be performed….In other words, claim 1 as written covers at least two methods, one in which the prerequisite condition for the triggering step is met and one in which the prerequisite condition for the determining step is met. Thus, the broadest reasonable interpretation encompasses a method where only the steps of "collecting physiological data associated with the subject from the implantable device at preset time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data," "comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event," and "triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria" are performed.
The board then sustained the Examiner’s rejection as follows:
The Examiner in this case was able to present a prima facie case of obviousness as to claim 1 by providing evidence to show obviousness of the "collecting," "comparing," and "triggering" steps. The Examiner did not need to present evidence of the obviousness of the remaining method steps of claim 1 that are not required to be performed under a broadest reasonable interpretation of the claim (e.g., instances in which the electrocardiac signal data is not within the threshold electrocardiac criteria such that the condition precedent for the determining step and the remaining steps of claim 1 has not been met).
Returning to the claims at issue in the ‘610 patent, similar limitations are present:
…performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day…
Thus, following the rationale set forth by Ex Parte Schulhauser, the claim element of “if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less” could be overlooked on the assumption that, given the broadest reasonable interpretation, claim 1 would end once a patient was determined to not have the CYP2D poor metabolizer genotype and iloperidone was administered to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day, which would have involved a completely different analysis of the alleged obviousness of claim 1. Looking to the decision from the district court (Vanda Pharm. Inc. v. Roxane Labs., Inc., 203 F. Supp. 3d 412 (D. Del. 2016)), evidence was presented supporting the notion that it was known to test patients to determine whether or not the patient had a CYP2D6 poor metabolizer genotype, and that it was known to administer iloperidone to a patient in an amount that is greater than 12 mg/day, up to 24 mg/day.
However, the possibility that claim 1 of the ‘610 patent may be non-obvious over the cited references due to the broadest reasonable interpretation of claim 1 only including the method of “performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype” and “if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day” was not raised by the defendants. Perhaps the defendants concluded that this argument was weaker than the other arguments put forth. In any event, the fact that the Federal Circuit upheld the validity of claim 1 of the ‘610 patent, which includes language similar to the allegedly conditional language in Ex Parte Schulhauser, calls into question the decision set forth in Schulhauser. One wonders, if the defendants had raised the issue of the conditional language in claim 1 of the ‘610 patent, would the Federal Circuit have decided differently? From reading the decision, it seems unlikely to say the least.