by Dennis Crouch
In an 8-4 Federal Circuit has denied HZNP’s petition for en banc rehearing over a vigorous dissent from Judge Lourie (joined by Judges Newman, O’Malley, and Stoll).
The focus of the petition is the “reasonable certainty” indefiniteness standard in relation to the un-expressed elements of an invention claimed using the transitional phrase “consisting essentially of.” In its original October 2019 holding, the Federal Circuit explained that the “consisting essential of” transition indicates that the claim requires the listed elements and is also “open to unlisted ingredients that do not materially affect the basic and novel properties of the invention.” In that framework, the “basic and novel properties of the invention” become a claim limitation that itself must be definite.
HZNP’s claim at issue here is directed to a pain-treatment ointment “consisting essentially of” 2% diclofenac sodium; 40% DMSO; etc. (Sold as PENNSAID). The specification indicated that “better drying time” was one of the improvements provided by the invention. The specification provided two methods of evaluating better drying time. However, those methods were ruled inconsistent and without a standard for PHOSITA to evaluate drying time. Since the novel feature was indefinite, the court found that the claim itself was indefinite.
This outcome is clearly problematic for current patent application drafting practice because only a minority of patent applications expressly identify and explain the novel features of the invention. One reason why those are not explained apriori is that the inventor’s understanding of novelty shifts as the patent application moves through the patenting process (or even later during litigation) and more prior art is unearthed. Although not entirely clear, it looks to me that the proposed method of claim interpretation uses a more subjective novelty — what did the patent applicant think was the novel feature.
In its en banc petition, HZNP asked the Federal Circuit to hold that the “basic and novel properties” were not claim elements and thus not subject to the “reasonable certainty” requirements of Nautilus and 112(b). The patentee provided three separate arguments:
- The plain language of 35 U.S.C. § 112, ¶ 2 restricts application of the definiteness standard to claim limitations;
- The “basic and novel properties” of the invention are not claim limitations since an infringer need not practice those properties in order to infringe; and
- Our tradition has never applied the definiteness standard to the “basic and novel properties” of an invention.
Judge Newman dissented in the original panel decision and joined Judge Lourie’s dissent from en banc rehearing. The basic thrust of the dissents is as following:
Better drying time is not in the claim, and it is the claims that the statute requires be definite.
Dissent. The dissent also notes that the patentee likely created the problems here by providing two methods of measuring — “one wonders whether, if this patent did not recite the methods by which better drying time was measured, any indefiniteness of the “consisting essentially of” language would have arisen at all.”
The question I would ask is whether we should require disclosure of the basic and novel properties of the invention as part of every patent specification — perhaps as part of the written description requirement. The dissent appears to assume that these are a requirement of the utility doctrine — but notes that utility is such an easy test that it is not even challenged unless “not credible.”