BPAI gives expert testimony little weight, for discussing state of the art before filing date and admitting no knowledge of reference before litigation

Takeaway: In an appeal from an ex parte reexamination, the patentee submitted a number of expert depositions from related litigation in support of various non-obviousness arguments.  In affirming the Examiner's obviousness rejections, the BPAI suggested that the expert testimony was not probative because the testimony related to the state of the art at a time well before the filing date. The BPAI also suggested that the testimony had little value because the experts admitted they were not even aware of the prior art systems at the time of filing. (Ex parte Baxter International, Inc., BPAI 2010.)

Details:

Ex parte Baxter International, Inc.
Informative Opinion
Appeal 2009006493; Reexamination No. 90/007,751; Patent 5,247,4341; Tech. Center 3900
Decided  March 18, 2010


This was an appeal in an ex parte reexam. The patent relates to a touch screen user interface for a  kidney dialysis machine. A representative claim on appeal read:

12. In a method of operating a hemodialysis machine, an improvement in a user/machine interfacing process, the improvement comprising:
   (a) providing a touch screen operably coupled to the machine, the touch screen adapted to display an indicium soliciting a user of the machine to touch a region on the screen so as to select a machine-operation parameter;
   (b) touching the region to select the machine operation parameter;
   (c) in response to said touching, invoking on the screen a data-entry display associated with the machine-operation parameter, the data entry display including a display of a permissibly settable range of the machine-operation parameter, so as to allow the user to select and enter a parametric value associated with the machine-operation parameter within said range; and
   (d) touching the data-entry display to select and enter the parametric value so as to cause the machine to operate in conformance with the selected machine-operation parameter and the entered parametric value.

During the reexam, the Examiner rejected the claims as obvious. As a primary reference, the Examiner used "the CMS08 Handbook," a manual for a dialysis machine which used a control panel for input and a screen for display. As a secondary reference, the Examiner used a "SARNs 9000" manual describing a blood perfusion machine with a touch screen that supported both input and display. In response to the rejection, the patentee put forth various arguments of non-obviousness, and included various depositions from a related litigation to support some of these arguments.

The patentee made a number of arguments in the Appeal Brief. One of the arguments attacked the prima facie case of obviousness by explaining why a POSITA would not combine the asserted references. The patentee used the litigation depositions to provide factual support for this argument. For example:

   Finally, the Patent Owner maintains that an ordinary artisan in the field of hemodialysis would not have looked to the cardio-pulmonary bypass (CPB) field for help in solving the problems of traditional user control of hemodialysis function. Baxter (the Patent Owner) and Fresenius (the Reexamination Requestor) are the two largest dialysis companies in the world. In the nearly five-year litigation surrounding these patents, almost sixty depositions were taken, including all of the named inventors, key present and past R&D personnel for both companies, numerous senior marketing executives, nephrologists, and other third-party witnesses in the dialysis field. It is hard to imagine a more representative sample of those "skilled in the art." Yet not a single witness from either Baxter or Fresenius had even heard of the Sarns machine. This fact speaks volumes about whether one of ordinary skill in the art of hemodialysis machines would have looked to the cardio-pulmonary bypass field for inspiration or problem-solving help.
   As Dr. Lee Henderson, Baxter's expert consultant in hemodialysis and nephrology, points out in his expert report: "Based on my experience during the relevant time, there was very little, if any, technical exchange between engineers designing HD equipment and those designing heart-lung machines."
(Emphasis added, internal citations omitted.)

In the Answer, the Examiner treated the patentee's "POSITA would not combine" argument as a non-analogous art argument:

   Appellants argue that testimony of Dr. Dennis Brunner and Lee Henderson supports the contention that the artisan would not have knowledge, awareness nor would have looked to the prior art in design of a touch screen hernodialysis device. Such testimony, while expert opinion is an argument akin to an assertion that the references are non-analogous art. These arguments are non-persuasive [because] the substantive issue here is more basic. The artisan already possessed functional hemodialysis devices [the CMS08] with suitable controls, guidance to selectable variables and alarm limits. ... The issue before the artisan was clearly more simple, related to the ease with which the user might analyze and effect a change in certain hemodialysis parameters. The issue comes down to one of programming, and whether the artisan would be guided to the art accepted input/output device of a touch screen to effect such parameter changes.

The Board affirmed all of the Examiner's obviousness rejections. After making various findings of fact about the teachings of the references, the Board concluded that:

[T]he collective teachings of the applied prior art references would have prompted a person of ordinary skill in the art to couple a touch screen interface with a hemodialysis machine. ... The interrelatedness of the prior art teachings, coupled with the expectation that a technique used to improve one device would also improve other similar devices, amply support the Examiner’s obviousness conclusion. KSR, 550 U.S. at 417-18.

In discussing the patentee's rebuttal evidence, the Board noted that the expert testimony was not credible because it focused on the wrong time period.

We also find no error in the Examiner’s refusal to credit the testimonies of certain experts as supporting Appellant’s skepticism or lack of a reasonable expectation of success argument. As pointed out by the Examiner, these experts testified on the knowledge of a person of ordinary skill in the art at a time period significantly before the relevant filing date. We have not been directed to any evidence indicating that further advances in touch screen technology did not occur up to the relevant filing date. 

The Board also discounted the expert evidence because it failed to take into account the teachings of the asserted references:

Moreover, we have not been directed to any evidence that these witnesses, before giving their testimonies, considered the teachings of the applied prior art references, which plainly disclose the successful incorporation of touch screen interfaces into critical medical systems. Indeed, Appellant has admitted that “not a single witness from either Baxter or Fresenius had even heard of the [prior art] Sarns machine.” That admission reveals the lack of any substantial value in the relied upon evidence vis-a-vis Appellant’s argument.

Postscript: The patentee has appealed the BPAI decision to the Federal Circuit.

Other Blog Coverage: The BPAI marked this decision "Informative," but I've no reason to think this status has anything to do with the issues discussed here. Several other bloggers have said the Informative status is due to the BPAI's discussion of the differing standards of validity applied to reexam and litigation.

See "District Court Analysis v. PTO Reexamination Analysis" at Patents Post-Grant and "BPAI Informative Opinion Underscores Different Validity Standards for Reexams" at The 271 Patent Blog.

For an explanation of precedential, informative and routine status, see my post "Meaning of BPAI Precedential and Informative Opinions."

My two cents: The Board's point about the time period considered by the experts is well taken. That is, the viewpoint for non-obviousness is the time of filing, so whether or not POSITAs would have used touch screens a full five years before filing is not very probative. Remember that when gathering your rebuttal evidence.

On the other hand, the Board took a cheap shot with the quote "not a single witness had even heard of [the prior art] Sarns machine." The evidence in question was not submitted for the purpose of distinguishing the reference. Instead, the evidence was submitted as a factual statement about why an actual person in the art did not look to prior art like the Sarns machine – because that person simply didn't think of perfusion machines when addressing a problem with a dialysis machine. So why is it a big deal that the witness was unaware of the Sarns perfusion machine?

Perhaps the Board is making a bigger point: that anyone involved in designing user interfaces for dialysis machines who isn't familiar with the touch screen interface on the Sarns perfusion machine isn't a true POSITA? If so, I'd like to hear an explanation of why the Board thinks that is the case.

The patentee offered evidence from real people involved in product development. Is the law even interested in what actual persons in the art did or didn't do, looked at or didn't look at? I appreciate that obviousness is from the viewpoint of a hypothetical POSITA. But what's wrong with using real POSITAs to inform our understanding of the hypothetical POSITA?

Sure, there may be concerns about the credibility of POSITA testimony when the POSITA has a connection to the patentee or applicant. Fair enough. The fact finder can take that into account.

But suppose you had 100 disinterested POSITAs say "I wouldn't have combined A with B and here's why." Do you ignore that information because we're only interested in what hypothetical POSITAs would do, rather than what real ones would do? Or, in the case of Baxter, did not do (look to perfusion machines).

Related Posts: I'll be doing another post about Ex parte Baxter that discusses the "skepticism of experts" doctrine in more detail.  The Board didn't have much to say about the merits of this argument (only about the credibility of the testimony), but the Examiner's comments are worth discussing.

BPAI reminder that declaration of unexpected results must include statement that results are unexpected

Takeaway: The BPAI found that the Applicant's evidence of unexpected results was insufficient to rebut the prima facie case of obviousness because the expert declaration failed to state the results were unexpected. Arguments in the Appeal Brief did characterize the results as unexpected, but the Board pointed out that "attorney argument is not evidence." (Ex parte Uchida, Appeal 2011000486.)

Details:

Ex parte Uchida
Appeal 2011000486; Appl. No. 11/731,595; Tech. Center 1600
Decided: July 7, 2011

The claims were directed to a chemical composition. One of the limitations at issue read "the inorganic heat generating agent is magnesium sulfate having an average diameter of from about 0.01 μm to about 40 μm."

The Examiner rejected the claims as obvious. On appeal, the Applicant argued that the average diameter limitation was not taught or suggested by the combination of references. The Appeal Brief also referred to previously submitted evidence showing that the claimed particle diameter produced unexpected results.

The Board found that the claim language "to about 40 μm" was broad enough to encompass the 50 μm particle in one of the references. The Board also found that the evidence of secondary considerations was flawed:

Although the Uchida [expert] Declaration shows that 1 micron particles produce a slightly higher maximal temperature than 50 micron particles, neither the Specification nor the Declaration states that this result was unexpected. Cf. In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995) (“[W]hen an applicant demonstrates substantially improved results . . . and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary.”). Here, the only characterization of the results as unexpected is in the Appeal Brief, and attorney argument is not evidence.
(Emphasis added.)

The Board also criticized the evidence as not being commensurate with the claim scope. "[T]he claims encompass a particle size range of about 1 μm to about 40 μm, and the evidence shows results only at the lower limit of the claimed range."

Having found the record "devoid of evidence" that actually showed unexpected results, the Board affirmed the obviousness rejection.

My two cents: If you're spending the time and money to submit evidence of secondary considerations, do it right. Note that two of the points made by the Board apply to all types of secondary considerations:

• In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978) (“[O]bjective evidence of non-obviousness must be commensurate in scope with the claims…”). 
• Estee Lauder, Inc. v. L'Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997)("However, arguments of counsel cannot take the place of evidence lacking in the record.").

Also be aware that specific types of secondary considerations (e.g., commercial success, unexpected results, etc.) have other requirements. So look up the relevant case law and make sure your evidence complies. For example, the Board didn't mention this in Uchida, but the unexpected results doctrine requires that the results be unexpected as compared to the closest prior art.  

• In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991)(“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”).