The issue arose in the University's lawsuit for patent infringement against L'Oreal S.A. and L'Oreal USA, Inc. over U.S. Patent Nos. 6,423,327 and 6,645,513; the opinion sets forth claim 1 of the '327 patent as representative:

1.  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 10^-4 M to 10^-7.

(Where the District Court's construction of the italicized language was the basis for its determination that the claims were invalid for being indefinite.)

While the District Court proceedings were ongoing, L'Oreal USA petitioned the Patent Trial and Appeal Board (PTAB) for institution of inter partes review, which the Board denied.  However, the Board in making its assessment of the institution petition construed the "wherein" clause of claim 1 of the '327 patent to mean the concentration of adenosine at the dermal cells (located underneath the skin surface) rather that the concentration at the skin surface (which comprises the epidermis) (the opinion noting that under 35 U.S.C. § 314(d) these determinations were "final and unappealable").  The District Court also construed the wherein clause to have this meaning without overt construction, holding that the clause was given its "plain and ordinary meaning without the need for further construction."

In applying this construction to the question of invalidity under 35 U.S.C. § 112(b), the District Court granted summary judgment for L'Oreal USA that the claim was indefinite in reciting the limitation "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" because of the perceived distinctness between the amount of adenosine (directly) applied to the epidermis and the amount (indirectly) applied to the dermal cells and the resulting concentration that is sufficient to both enhance the condition of the skin while not increasing dermal cell proliferation.

The Federal Circuit reversed the District Court's claim construction and vacated summary judgment of indefiniteness in an opinion by Judge Taranto, joined by Judges Mayer and Prost.  The University argued with regard to the claim construction issue that the concentration recited in the wherein clause should be construed to mean the amount of adenosine in the dermis after it has entered the dermal layer, i.e., "the number of moles of adenosine divided by the volume (liters) of the dermis itself."  The Federal Circuit disagreed, holding that the District Court had erred in its construction and vacating and remanding for proceedings based on the Court's construction as set forth in this opinion.  (Review was de novo, because  the District Court relied only upon intrinsic evidence.)  The Court's analysis began with its determination that the meaning of the concentration language in the wherein clause, viewed in the context of the claim as a whole, was not plain and even less plain under the University's construction of it.  The opinion notes that the clause recites adenosine concentration administered to the dermal cells, while the preceding clause relating to skin enhancement recited applying the adenosine-containing composition to the skin (the epidermis). While the way the claim is written with regard of the term "applied" suggested to the panel (as it did to the Board and District Court) a difference in meaning, that is not enough according to the opinion.  The panel recognized that "[t]he same [composition] can be applied directly to one object [(the skin)] and indirectly to the other [(the dermis)]."  Under the Federal Circuit's construction, the concentration of adenosine referenced in the two portions of the claim are the same concentration, which the opinion states is consistent with the language of the dependent claims as well.  The concentration referenced in the skin-enhancement clause refers to the concentration in the composition before it is applied to the skin, which is the same concentration referenced in the wherein clause in the Court's opinion, contrary to the University's proposed construction.  According to the opinion, the University's construction would have the concentration recited in the wherein clause refer to something that does not exist until the composition is applied (and the adenosine absorbed into the skin and the dermal layer).  But if that construction was followed, the wherein clause (in the Court's view) would need to be rewritten to recite "wherein the adenosine permeating to the dermal layer results in a concentration of adenosine in the dermal layer of 10^-4 M to 10^-7 M."  The need for these linguistic gymnastics was enough for the panel to hold that the claim language at issue had no plain meaning and that resort to the specification and prosecution history was in order.

In its review of the disclosure in the specification, the many recitations of the concentration of adenosine in the disclosed composition did not set forth this concentration after penetration into the dermal layer; instead they all disclose concentrations before the composition is applied to the skin.  The opinion states that "[t]his is significant evidence that the wherein clause is best read to refer to the concentration of adenosine in the composition applied to the surface of the skin," referencing Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc); VirnetX, Inc. v. Cisco Systems, Inc., 767 F.3d 1308, 1318 (Fed. Cir. 2014); and Netcraft Corp. v. eBay, Inc., 549 F.3d 1394, 1397–98 (Fed. Cir. 2008).  And there is no disclosure of measuring adenosine concentration in the dermis or the need to do so.

But it is in the prosecution history that the Court found the most persuasive evidence for its construction that the concentration recited in the claims should be construed as the adenosine concentration in the composition before application to the skin.  The Court first looked to the claims as filed, which did not recite the wherein clause present in the claims as granted (that limitation was recited in a dependent claim, but without any mention of dermal cells).  The applicants amended the claim to overcome prior art, and in incorporating the adenosine concentration limitation into the independent claim changed the wording to what was recited in claim 1 of the '327 patent.  However, in their response containing this amendment, the applicants maintained that "[t]his amendment would add no new matter, as it merely includes a range of concentrations of adenosine recited in dependent claims" (emphasis in opinion).  In this response the applicants further distinguished two other prior art references based on concentration of adenosine in the composition before being applied to the skin (as the opinion states, "with no suggestion of a difference in location of concentration measurement").  And the examiner's comments in the reasons for allowance, both in the '327 patent and the '513 patent, contained the statement that the "[i]nstant claims are directed to a method of enhancing the condition of unbroken skin . . . where the method comprises administering adenosine at a concentration of 10^-4 M to 10^-7 M, to the skin" (emphasis in opinion).  In view of this prosecution history, the Federal Circuit held that "the wherein clause's reference to the recited concentrations being 'applied to the dermal cells' be read as referring to concentrations of the composition applied to the skin's surface."  The construction the University advanced before the District Court and on appeal was inconsistent with this history according to the opinion, and "cannot fairly be squared with the understanding that both [the University] and the examiner expressed during prosecution, and on which skilled artisans are entitled to rely," this latter phrase perhaps providing the impetus for the Court's decision.

And in remaining unpersuaded by the University's attempts to distinguish the prosecution history, the Court refused to credit statements in the prosecution history made in response to the examiner's reasons for allowance, which merely recited the claim language and asserted that the applicants did not concede that the examiner's reasons were the only reasons the claims should be allowed (illustrating the futility in believing that such statements would be persuasive in actions to enforce the patent).

The Federal Circuit, applying its construction concluded that the District Court's finding that the claims were indefinite "must be vacated and . . . remanded for the district court to conduct any further proceedings that are necessary" (the panel refusing L'Oreal's suggestion that it enter a judgment of non-infringement directly).

Regarding the jurisdictional question, the District Court adopted a magistrate judge's recommendation that the Court grant L'Oreal S.A.'s motion to dismiss under Federal Rule of Civil Procedure 12(b)(2) without permitting jurisdictional discovery to the University.  The Federal Circuit disapproved of that action, holding that under Third Circuit law it was an abuse of discretion.  The basis for this holding was that "at the very least" jurisdictional discovery was appropriate under Eurofins Pharma US Holdings v. BioAlliance Pharma SA, 623 F.3d 147, 157 (3d Cir. 2010).  The University had "made more than clearly frivolous, bare allegations that L'Oréal S.A. was subject to personal jurisdiction," these allegations including that "L'Oréal S.A. introduced the accused products into the stream of commerce" and that L'Oreal USA was "L'Oréal S.A.'s agent in certain potentially relevant respects."  There was also evidence that L'Oreal S.A. had performed product research on adenosine-containing compositions for treating skin and may have licensed the technology to L'Oreal USA.  Also telling for the panel was that "L'Oréal S.A. did not specifically deny allegations that it developed and licensed the relevant technology to L'Oréal USA" but instead had rather weakly asserted that it had not "directly developed" any of the skincare products at issue in the lawsuit.  The Federal Circuit held that because "this evidence raises the possibility that discovery might have uncovered the requisite contacts under our precedent" (emphasis in opinion), it vacated the District Court's jurisdictional determinations and held that on remand the University was entitled to jurisdictional discovery before the District Court came to and jurisdictional conclusions.

University of Massachusetts v. L'Oreal S.A. (Fed. Cir. 2022)
Panel: Circuit Judges Prost, Mayer, and Taranto
Opinion by Circuit Judge Taranto