Merely Because a Technology is Known, Does Not Mean There Was a Motivation to Use It

In Virtek Vision International ULC v. Assembly Guidance Systems, Inc., [2022-1998, 2022-2022] (March 27, 2024), the Federal Circuit reversed the PTAB determination that certain claims of U.S. Patent No. 10,052,734 were unpatentable, and affirmed the determination that other claims of the ‘734 patent had not been shown to be unpatentable.

The ’734 patent discloses an improved method for aligning a laser projector with respect to
a work surface. On appeal, Virtek argued the Board’s findings that a skilled artisan would have been motivated to combine the references were not supported by substantial evidence, and the Federal Circuit agreed.

The Federal Circuit said that it does not suffice to meet the motivation to combine requirement to recognize that two alternative arrangements (such as an angular direction system using a single camera and a 3D coordinate system using two cameras) were both known in the art.

These disclosures, however, do not provide any reason why a skilled artisan would use 3D coordinates instead of angular directions in a system. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only
could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).

The Federal Circuit said that the mere fact that possible arrangements existed
in the prior art does not provide a reason that a skilled artisan would have substituted the one-camera angular direction system in one prior art system with the two-camera 3D coordinate system disclosed in another. The Court noted that there was no argument in the petition regarding why a skilled artisan would make this substitution—other than that the two different coordinate systems were “known to be used.” The petition did not argue that the references articulates any reason to substitute one for another or any advantages that would flow from doing so, and neither did Petitioner’s expert articulate any reason why a skilled artisan would combine these references.

The Federal Circuit said that KSR did not do away with the requirement that there must exist a motivation to combine various prior art references in order for a skilled artisan to make the claimed invention. The Federal Circuit said that there was no argument about common sense in the petition or in the expert’s declaration. There was no evidence that there are a finite number of identified, predictable solutions. There was no evidence of a design need or market pressure. In short, this case involved nothing other than an assertion that because two coordinate systems were disclosed in a prior art reference and were therefore “known,” that satisfies the motivation to combine analysis. That is an error as a matter of law. It does not suffice to simply be known. A reason for combining must exist.

Expert Testimony on Lack of Motivation Won the Battle, but Lost the War

In BayerPharma AG v. Watson Laboratories, Inc., [2016-2169] (November 1, 2017), the Federal Circuit reversed the district court’s holding that claims 9 and 11 of U.S. Patent No. 8,613,950 would not have been obvious.

The district court rejected each of Watson’s arguments. It found a person of ordinary skill in the art would not have been motivated to
create an ODT formulation of vardenafil and would not have used mannitol and sorbitol as excipients. It found the prior art taught away from formulating vardenafil ODT as immediate-release. The district court also addressed Bayer’s objective evidence of nonobviousness and
found it supported its conclusion that Watson failed to prove by clear and convincing evidence that claims 9 and 11 would have been obvious.

The district court determined that Watson failed to meet its burden of proving by clear and convincing evidence that there would have been a motivation to formulate vardenafil as an ODT formulation largely on the court’s finding the testimony of Bayer’s expert, Dr. Wicks, more persuasive than the testimony of Watson’s expert, Dr. Jacobs.  The Federal Circuit said that the clear error in the district court fact finding that there was no motivation to formulate ED drugs in ODTs, is that it concluded that the record did not contain an indication that ED drugs would be good candidates for ODT formulations.  The Federal Circuit noted that the district court’s opinion did not discuss any of the references that Watson cited to show that ED drugs would be good candidates for ODT formulations.

It is well within the district court’s discretion to credit one expert’s competing testimony over another. The Federal Circuit said it must give due regard to the trial court’s opportunity to judge the witnesses’ credibility.  However, a district court cannot, through a credibility determination, ignore the wealth of evidence, especially as in this case where the expert did not even address it.

The Federal Circuit also faulted the district court’s focus on the fact that  no ODT ED drug had gained FDA approval as of ’950 patent’s priority date.  The Federal Circuit said that  the motivation to combine inquiry is not limited to what products are forthcoming or currently available on the market.  The Federal Circuit said that any motivation, “whether articulated in the references themselves or supported by evidence of the knowledge of a skilled artisan, is sufficient.

The Federal Circuit was left with the definite and firm conviction that the district court clearly erred when it found there would not have been a motivation to formulate vardenafil ODT.

The district court also found a person of ordinary skill in the art would not have been motivated to use mannitol and sorbitol in an ODT formulation, again finding Dr. Wicks’ testimony on this limitation more credible than Dr. Jacobs’.  The Federal Circuit did not question the district court’s credibility determinations. However, the district court’s analysis for the sorbitol and mannitol limitation focused on the  commercial availability of products while failing to address relevant prior art. Upon consideration of the entire record and under a proper analysis, we conclude that the district court clearly erred in finding a person of ordinary skill in the art would not have been motivated to formulate an  ODT with sorbitol and mannitol.

Finally, the Federal Circuit rejected the district court’s determination that vardenafil’s expected bitter taste taught away from an oral formulation.  The Federal Circuit noted that a reference teaches away when it suggests that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant.  The Federal Circuit said that the district court did not find that a person of ordinary skill in the art would have believed vardenafil’s expected bitter taste and increased bioavailability would have
likely rendered an immediate-release formulation unproductive, but instead focused on whether a person of ordinary skill in the art would have pursued other alternatives.  The Federal Circuit said that the teaching away inquiry does not focus on whether a person of ordinary
skill in the art would have merely favored one disclosed option over another disclosed option.  In assessing whether prior art teaches away, that better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes.

Weighing all four Graham factors, the Federal Circuit concluded that
claims 9 and 11 of the ’950 patent would have been obvious. The repeated suggestion in the prior art to make an ODT formulation of an ED drug and the suggestion to use the combination of sorbitol and mannitol as excipients were strong evidence of a motivation to make the claimed combination.

Just Because the Board Didn’t Say It; Doesn’t Mean that the Board Didn’t Think It

In Novartis AG v. Torrent Pharmaceuticals Limited, [2016-1352] (April 12, 2017), the Federal Circuit affirmed the PTAB’s determination that the challenged claims of U.S. Patent No. 8,324,283, and Novaritis’ proposed substitute claims, were unpatentable as obvious.

On appeal, Novaritis that it was denied due process under the APA when the the Board used a reference that it rejected as being anticipatory in the institution decision, as additional evidence of the reason to combine.

The Federal Circuit noted that under the APA, and an agency
may not change theories in midstream without giving respondents reasonable notice of the change and ‘the opportunity to present argument under the new theory.  The Federal Circuit disagreed that the Board ruled the reference out of the case entirely in the Institution Decision.  Th Federal Circuit said that the Board merely used the reference to reinforce its finding of obviousness, and that the Board’s discussion of the reference in the Final Written Decision was not inconsistent with its review of the reference in the Institution Decision.  The Federal Circuit further noted that the parties debated the reference at length throughout the proceeding and in the same context that it was discussed by the Board in the Final Written
Decision.  The Federal Circuit concluded that it is quite clear that
Novartis had more than sufficient notice and opportunity to be heard the reference’s potential relevance, and in fact actively and repeatedly attempted to distinguish the reference to defeat the very argument relied on by the Board in the Final Written Decision.

Novartis also argued that the Board further erred in its motivation to combine analysis because it failed to read the prior art as a whole and overlooked critical evidence of the combination’s known disadvantages.  Where the prior art contains apparently conflicting teachings (i.e., where some references teach the combination and others teach away from it) each reference must be considered for its
power to suggest solutions to an artisan of ordinary skill, considering the degree to which one reference might accurately discredit another.  The Federal Circuit noted that the Board expressly discussed the negative properties in the Final Written Decision, and noted that, despite this potentially discouraging characteristic, it was still commonly used.  In the end, the Federal Circuit was not persuaded that Novartis presented its arguments in such a way that it would be appropriate to find fault in the Board’s arguably limited treatment of those arguments in the Final Written Decision.

Although the prior art must be considered as a whole and the disadvantages of a reference must be considered in addition to the benefits, there is no requirement that the Board expressly discuss each and every negative and positive piece of evidence lurking in the record to evaluate a cursory argument. Given that the Board cited to the relevant pages of Novartis’ Patent Owner Response, we find no reason to assume the Board failed to consider the cited negatives simply because they were not recited at length in the Board’s Final Written Decision.

With respect of objective indicia of non-obviousness,  the Board rejected Novaritis argument of unexpected results because it was not commensurate with the scope of the claims.  On appeal Novaritis argued that the evidence nonetheless applied to the narrower dependent claims, but the Federal Circuit found that Novaritis did not separately argue the dependent claims, and therefore waived the argument.

Novaritis further argued that the invention enjoyed commercial success, industry praise, and met a long-felt but previously unsolved need.  For objective indicia evidence to be accorded substantial weight, a nexus must exist between the evidence and the merits of the claimed invention.  Where the objective indicia actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.  The Federal Circuit agreed that Novartis’ proffered evidence is not probative of the
nonobviousness inquiry, because other products were known with the same feature, even though had not yet been approved by the FDA.