Subjective Terms Require Objective Definition

Holding

In Univ. of Mass v. L’Oréal USA, Inc., No. 17-cv-0868 (D. Del. April 20, 2021), the district court judge granted L’Oréal’s motion for summary judgment of invalidity for indefiniteness.

Background

UMass sued L’Oréal for infringement of U.S. Pat. No. 6,423,327 (“the ‘327 patent”) and 6,645,513 (“the ‘513 patent”). Claim 1 in each read:

[a] method for enhancing the condition of unbroken skin of a mammal by reducing one or more of wrinkling, roughness, dryness, or laxity of the skin, without increasing dermal cell proliferation, the method comprising topically applying to the skin a composition comprising a concentration of adenosine in an amount effective to enhance the condition of the skin without increasing dermal cell proliferation, wherein the adenosine concentration applied to the dermal cells is [a recited concentration range].

According to L’Oréal, the “skin enhancement limitation” in italics above was indefinite.

UMass argued that the skin enhancement limitation should be construed to mean the concentration ranges recited in the "wherein" clause of the asserted claims. UMass, at 5. L’Oréal challenged UMass’ proposed construction but did not offer one of its own. Id. at 9.

District Court

The district court disagreed with UMass’ proposed construction, finding that such construction would “collapse the skin enhancement limitation into the recited concentration range limitation.” Id. at 6. Instead “the plain and unambiguous language of the asserted claims makes clear that the skin enhancement limitation is distinct from and independent of the recited concentration range limitation.” Id. The district court explained that the skin enhancement limitation referred to the concentration of the adenosine composition applied topically in an amount effective to enhance the skin’s condition. By comparison, the range limitation requires the concentration of the adenosine composition applied to the dermal cells lie within the recited ranges. Id. at 6-7.

The court found that during the earlier claim construction of the range limitation, UMass expressly noted the distinction between the two limitations by arguing that the composition applied topically was not restricted to the recited ranges, and that by contrasting “the skin” and “the dermal cells,” the patent drafter indicated the amount of adenosine applied was not identical. 

Therefore, the district court concluded that the skin enhancement limitation should not be construed as restricted to the recited ranges. However, it is required to have a concentration “effective to enhance the condition of the skin.” Id. at 9.

The court found that the claims did not define what constitutes enhancement nor explain how one of ordinary skill in the art can determine what constitutes enhancement. Id. Since neither side suggested that one of ordinary skill in the art would interpret the term differently than a lay person would, the court first looked at the ordinary meaning of the term, which was found to be “improving or making better the quality or desirability of the skin.” Id. at 9-10. Such meaning, according to the court, was “clearly indefinite.” Id. Indeed, the determination of whether a person’s skin is enhanced provides a paradigmatic example of indefiniteness.” Id. at 10.

Next, turning to the specification to determine if the patent drafter provided a special definition, the court found only subjective language and even an explicit acknowledgement that determination of “enhancement” could be “purely subjective”:

In this case, the patents' written descriptions define ‘enhancement of skin condition’ to mean ‘a noticeable decrease in the amount of wrinkling, roughness, dryness, laxity, sallowness, or pigmentary mottling in skin.’ The claims do not define or suggest what constitutes a ‘noticeable decrease’ …  Nor do they describe how an artisan of ordinary skill would ascertain whether an application of the adenosine resulted in such a noticeable decrease.  … ‘[m]ethods of measuring improvements in skin condition are well known in the art (see, e.g., Olsen et al., J. Amer. Acad. Dermatol. 26:215-24, 1992), and can include subjective evaluations by the patient or a second party, e.g., a treating physician.’

Id. at 10-11.

The district court concluded that under either the plain and ordinary meaning or the patent specifications’ definition, the skin enhancement limitation was indefinite.

Artisans of ordinary skill seeking to avoid infringement of the asserted claims would have to guess about the opinions held by doctors, patients, and undefined others with respect to the qualities and desirability of skin conditions. The claims thus lack the requisite objective boundaries required by § 112.

Id. at 13.  Therefore, the court granted summary judgment of invalidity for indefiniteness.

UMass appealed, and oral arguments were heard on April 19, 2022, by a panel of Judges Prost, Taranto, and Mayer. Univ. of Mass. v. L’Oréal SA, No. 21-1969. Reports from the hearing indicated that the panel was skeptical of UMass’ argument that the district court judge erred and that subjective evaluations are permitted in the skincare field and done all the time. The panel further discussed whether any degree of subjectivity would render a claim indefinite or whether permitting some subjectivity (but not requiring it) was allowed.^[1] 

Takeaways

Subjective terms must be treated as carefully as technical terms of art. It is for the drafter to solve any ambiguity problem. “Courts construe claims ‘as written, not as the patentees wish they had written [them].’" Chef Am. Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004).” UMass, at 4. See also, Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573 (Fed. Cir. 1996)); Sage Products, Inc. v. Devon Industries, Inc., 126 F.3d 1420 (Fed. Cir. 1997). A drafter should act as his or her own lexicographer by providing a clear definition to the subjective terms. Specifically, it is unhelpful to define a subjective term with another subjective term, as the patent drafter did in the current case.

In order to provide the requisite objective boundaries required by § 112, aim to provide a set of objective (even quantitative if possible) measurable standards for the subjective term. The goal is a claim that will pass the test of “reasonable certainty” to one of ordinary skill in the art. Consistent with the public notice function of patent claims, can one of ordinary skill in the art be reasonably certain what will infringe?  

Patent drafters should always be on guard for subjective terms to avoid a holding of indefiniteness that wipes out the claims. For an example of relative terms surviving an indefiniteness challenge, see https://www.finnegan.com/en/insights/blogs/prosecution-first/relative-terms-sufficient-for-reasonable-certainty.html 

[1] See https://www.law360.com/articles/1485390/fed-circ-mulls-umass-bid-to-revive-l-oreal-skincare-ip-suit