Monday, August 23, 2010

Appellant loses argument that anticipatory reference is not enabling (Ex parte Given Image Ltd.)

Takeaway: In the reexamination appeal Ex parte Given Imaging Ltd., the Applicant argued that a reference with a short description and one figure wasn't enabling and thus wasn't anticipatory. Despite the presence of declaration evidence, the BPAI affirmed the anticipation rejection, finding that the reference was enabling for what the Applicant actually claimed. So if your claim is high-level, without a lot of detail, don't be surprised when the reference used against you is also high-level, or when your "reference isn't enabling" argument isn't found persuasive.

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:
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.
Claim 11 recited a different preamble – "autonomous video endoscope" – but was otherwise the same with respect to the issues discussed here.

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.


  1. Interestingly, it looks like the patentee filed a petition after the Board decision, but lost the petition too. The patentee also filed claim amendments and arguments, and I think (based on a cursory review) that the Petition was for the amendments and the remarks to be entered. But, because the Petition was denied, he lost. A Re-exam certificate was issued, canceling the rejected-and-affirmed claims.

  2. >Petition was for the amendments and the
    >remarks to be entered. But, because the
    >Petition was denied

    Yep, that's Re-exam. You lose an appeal during normal examination, you can file an RCE to narrow the claims and continue prosecution. But you don't get an RCE as a matter of right during reexam.

  3. "The Applicant also made an interesting argument about the presumption that a reference is operable – interesting, but unsuccessful."

    You're too kind. The appellant's counsel's attempt during oral argument to draw a distinction between U.S. provisionals and published, unexamined foreign applications was nonsensical.

    Filing a petition on the grounds that the law is now somehow clarified is terrible strategy. Narrower claims, or amendments, that were clearly not enabled by the applied references should have been added long before an (unsuccessful) appeal.

  4. >attempt during oral argument to draw a
    >distinction between U.S. provisionals and
    >published, unexamined foreign applications
    >was nonsensical.

    I scanned through the transcript, but don't recall having an opinion as to how good the oral arguments were. Most of the BPAI oral argument transcripts that I have read were not too impressive. If the oral arguments in this case were "nonsensical," that's probably a result of a lack of experience at oral arguments.

    >Filing a petition on the grounds that the
    >law is now somehow clarified is terrible

    I think Reexam in general, and Petitions for Continued Reexam in particular, are a specialized practice area. So I'm not prepared to say that that filing on those grounds was a terrible strategy.

    But I do think you're very unlikely to win at the BPAI if you're asking for a change in how the law is interpreted. You probably need to go to the Fed. Cir. for that. Maybe that was the plan all along.

    >Narrower claims, or amendments, that were
    >clearly not enabled by the applied
    >references should have been added

    I absolutely agree with you on this point. And you gotta do this early in a reexam, since you typically get only one chance to amend.

    That said, this Applicant is not that unusual. I read plenty of BPAI decisions where Applicants seems to have nothing but weak arguments, and where I think narrowing would have been a much better strategy.