Ex parte Given Imaging Ltd.
Appeal 200900064, Reexam Control No. 90/006,898, Patent No. 5,604,531
This was an appeal during reexamination of a medical imaging patent. Claim 1 recited:
1. An in vivo video camera system comprising:Claim 11 recited a different preamble – "autonomous video endoscope" – but was otherwise the same with respect to the issues discussed here.
a swallowable capsule comprising:
a camera system;
an optical system for imaging an area of interest onto said camera system; and
a reception system which receives said transmitted video output.
The Examiner issued two different anticipation rejections, using Yamazaki and Saito. The Applicant submitted declaration evidence to show neither reference was enabling, and thus could not anticipate.
The Applicant used the declarations to argue that Yamazaki disclosed a lens and a light source inside a gastric capsule, but did not enable "a functioning optical system," for various technical reasons explained in the declaration.The Applicant characterized Yamazaki's sparse description and single figure as "nothing more than an abstract idea."
With respect to Saito, the Applicant used the declarations to argue that while the application purported to disclose an endoscope, the disclosed device would not function properly as an endoscope, for various technical reasons explained in the declaration.
The declaration further stated that because of those technical deficiencies, neither reference "could have provided desired medical images without extensive redesign." Therefore, the Applicant argued, the references did not anticipate. "[I]nvalidity based on anticipation requires that the assertedly anticipating disclosure enabled the subject matter of the reference and thus of the patented invention without undue experimentation." Elan Pharms. v. Mayo Found. For Med. Educ. Research, 346 F.3d 1051 (Fed. Cir. 2003).
The Examiner's Answer reiterated that both Yamazaki and Saito disclosed each element of independent claims 1 and 11. With respect to the alleged lack of enablement, the Examiner maintained that the references did disclose a functioning optical system because they did produce images of some kind. While acknowledging that the "systems may not produce the desired medical images," the Examiner noted that arguments about "desired medical images" were outside the scope of the claims, which did not refer to image quality.
The Board affirmed both anticipation rejections, finding that both references disclosed each claim element. In doing so, the Board found that both references were enabling for what the Applicant actually claimed.
With respect to claim 1, the Board interpreted an “in vivo video camera system” as "a system capable of taking video pictures inside a body." The Applicant acknowledged in oral arguments that the systems disclosed in the references could produce some type of image. Therefore, the Board found that the references were enabling for claim 1. The Board said the Applicant's argument that the disclosed systems were not capable of producing images suitable for medical diagnosis was irrelevant, since the claim specified neither the type of image nor a particular image quality.
Where claim 1 recited "an in vivo video camera system," claim 11 recited instead an "autonomous video endoscope." The Applicant argued that the term "endoscope" implied and necessitated something capable of providing diagnostic images. The Board disagreed, finding that "Appellant’s Specification provides no such definition of an endoscope and uses the term to describe various types of devices." The Board interpreted "an autonomous video endoscope” to be "an independent capsule that captures in-body images." Using the same analysis applied to claim 1, the Board then found the disclosed systems were enabling for claim 11.
My two cents: The Applicant did one thing right here: submitted evidence to show the references weren't enabled. "Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes ... inoperability of the prior art ..." (MPEP 716.01(c).)
That couldn't make up for the fatal mistake committed by the Applicant here: arguing outside of the claims. Or, as the Board often puts it, "Applicant's arguments are not commensurate with the scope of the claims." Another way of looking at this decision is that it turned on claim construction: the Applicant interpreted "in vivo video camera system" and "endoscopic system" as producing images suitable for medical diagnosis; the Board said that interpretation was too narrow.
The Applicant also made an interesting argument about the presumption that a reference is operable – interesting, but unsuccessful. The Applicant acknowledged that issued patents are entitled to the presumption of operability, but argued that unexamined patent applications are not. The Board held that since the filing of a patent application is considered constructive reduction to practice, the presumption still applies. The concurrence in this opinion went much further, holding that any type of reference – including a newspaper article – should be presumed operable.