Takeaway: A patent owner must explain how each added limitation in a proposed substitute claim of a motion to amend finds written description support, and that requirement can become more burdensome depending on the amount of revisions made in the substitute claim.

In its Final Written Decision, the Board found that Petitioner established that claim 1 is unpatentable but failed to establish the unpatentability of claims 2, 4, 5, 8, 9, 16, 19, and 20. The Board also denied Patent Owner’s Motion to Amend and Petitioner’s Motion to Exclude Evidence.

The ’003 patent concerns wearable medical devices “used to provide therapy to the patient, as well as to collect and transmit information about the patient, the device, and the patient’s interaction with the device, to a remote location.” The proceeding was instituted based on anticipation of claims 1, 2, 4, 5, 8, 9, 16, 19, and 20 of the ’003 patent by the prior art reference Owen.

Turning to claim construction, the Board noted that “claim terms in an unexpired patent are interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear.” Unless a special definition is set forth in the specification “with reasonable clarity, deliberateness, and precision,” the terms are given their ordinary and customary meaning.  The Board first considered the parties’ arguments with respect to the construction of the terms “patent compliance data” and “patient compliance and use data,” finding neither persuasive and maintaining the constructions provided in the Decision on Institution.  In particular, the Board construed both terms to mean “data indicating whether a patient has followed instructions for use.”

The Board then addressed the means-plus-function limitations and provided a construction for the “means for monitoring and storing” limitation in claims 4 and 19. Petitioner argued that the corresponding structure in the specification that performs the “monitoring” and “storing” functions are a medical device and memory.  Patent Owner did not disagree.  Thus, the Board adopted the agreed-upon construction.  Although other proposed claim constructions were argued by the parties, the Board did not construe them, finding them not to be material to its decision.

With respect to the alleged unpatentability of claim 1, the Board noted that Patent Owner did not argue the patentability of the claim in its Response or subsequent papers. The Board was persuaded by Petitioner’s unrebutted evidence that Owen anticipates the subject matter of claim 1.

With respect to the remaining claims (2, 4, 5, 8, 9, 16, 19, and 20), the question of patentability was primarily based upon the claim limitation “patient compliance data,” which is found in each of those claims. Petitioner argued that a passage in Owen describing several types of information satisfied the limitation.  Addressing each type of information in turn, the Board agreed with Patent Owner, finding that Petitioner failed to identify where Owen discloses “whether a patient has followed instructions” as required by the limitation according to the Board’s construction.  Thus, the Board found that Petitioner had not shown that Owen discloses “patient compliance data,” and therefore, that Owen does not anticipate claims 2, 4, 5, 8, 9, 16, 19, and 20.

The Board then addressed Patent Owner’s contingent Motion to Amend, in which it proposed claim 36 as a substitute for claim 1. The Board explained that an inter partes review proceeding is neither an examination nor a reexamination proceeding.  Rather, Patent Owner “bears the burden of proof in demonstrating adequate written description support and patentability of the proposed substitute claims over the prior art, and thus entitlement to add these proposed substitute claims to its patent.”

With respect to the alleged written description support for substitute claim 36, Patent Owner provided a long series of citations to the ’003 patent and the provisional application to which it claims priority, and did not cite to its expert for support. Petitioner argued that Patent Owner’s Motion to Amend was not sufficient in this regard.  Patent Owner, in its Reply, argued that the discussion was sufficient to demonstrate possession of the subject matter of the claim to a person of ordinary skill in the art.  Patent Owner also submitted a declaration of its expert with the Reply in which “a more detailed listing of support” was provided.

The Board agreed with Petitioner that Patent Owner failed to show written description support for the proposed claim. In particular, the Board noted that the string citations were “little more than an invitation . . . to peruse the cited evidence and piece together a coherent argument.”  The string citations were particularly deficient in light of the extensive revisions to claim 1, with Patent Owner seeking to add hundreds of words to claim 1, more than tripling its length.”  Patent Owner’s attempt to address the deficiency in its Reply was found to be too late.  “A Reply affords the moving party an opportunity to refute arguments and evidence advanced by the opposing party, not an opportunity to improve its position.”  Also, Patent Owner failed to explain why the new evidence in the Reply could not have been presented with its Motion.

Nevertheless, the Board found that the reply evidence was still insufficient. In particular, the expert declaration opined that a person of ordinary skill in the art would have appreciated that the inventors had possession and provided citations to the provisional application.  However, the Board found that the declaration did not “explain adequately the factual basis on which he reaches that conclusion.”  Thus, the Board found that Patent Owner failed to demonstrate that the proposed claim has the required support and did not reach the question of the claim’s patentability over the prior art.

Finally, the Board addressed Petitioner’s Motion to Exclude portions of cross-examination testimony. First, the Board noted that Petitioner made blanket requests to exclude, for example, “all evidence it objected to as irrelevant or exceeding scope.”  The Board refused to consider any evidence that was not particularly addressed in the Motion to Exclude, and the only evidence that the Board relied upon in its decision was not specifically addressed in the Motion.  Therefore, the Board denied the Motion.

Respironics, Inc. v. Zoll Medical Corporation, IPR2013-00322
Paper 46: Final Written Decision
Dated: September 17, 2014
Patent: 6,681,003 B2
Before: Bryan F. Moore, Brian J. McNamara, and Scott E. Kamholz
Written by: Kamholz