"Near Edge of Ungual Crest" Not Indefinite

In Young v. Lumenis, Inc. (June 26, 2007), the Federal Circuit reversed an indefiniteness holding for a claim reciting "forming a first circumferential incision in the epidermis near the edge of the ungual crest of the claw." According to Circuit Judge Lourie,

That language implies that an incision is made in the epidermis somewhere close to or at the edge of the ungual crest. As used in the claim, the term "near" is not insolubly ambiguous and does not depart from the ordinary and customary meaning of the phrase "near" as meaning "close to or at" the edge of the ungual crest [15 below].

Reference to the specification shows that it is consistent with that understanding of the term. The specification makes reasonably clear that the first incision is made very close to or at the edge of the ungual crest. In the "Brief Summary of the Invention," the specification describes the invented method as including a first incision in the epidermis "at the edge of the ungual crest of the feline’s claw." ’579 patent col.1 ll.63-67. The specification further describes that the first incision "severs the most distal portion of the epidermis from the underlying fascia of the ungual crest." Id. Additionally, in the "Detailed Description of the Invention," the disclosure states that the first incision "is made near the most distal edge of the epidermis and extends circumferentially around the claw to sever the epidermis from the ungual crest." Id. col.4 ll. 39-42. Thus, based on the several descriptions in the specification, we understand the term "near the edge of the ungual crest" as recited in the claims to mean close to or at the most distal edge of the epidermis. In fact, Figure 2 shows an example of such an incision "near" the edge of the ungual crest, as illustrated by line A-A. That figure illustrates where the first incision is made in relation to the crest and phalanx, and provides a standard for measuring the meaning of the term "near."

Moreover, because the term "near" describes a location on an animal, its use, as opposed to a precise numerical measurement, is not inappropriate because the size of the appendage and the amount of skin required to be incised will vary from animal to animal based on the animal’s size. Akin to the term "approximately," a person having ordinary skill in the art would know where to make the cut; thus the use of the word "near" does not deprive one of ordinary skill from being able to ascertain where the cut should be made.

. . . Lumenis argues that the district court properly applied Amgen and determined that the term "near" is indefinite because it fails to distinguish the claims over the prior art. We do not agree that Amgen supports the district court’s decision. In Amgen, the invention was directed to homogeneous erythropoietin ("EPO"), a protein consisting of 165 amino acids that stimulates the production of red blood cells. 927 F.2d at 1203. The claim recited homogenous EPO characterized by the limitation "specific activity of at least about 160,000 IU per absorbance unit." Id. The district court determined that "bioassays provide an imprecise form of measurement with a range of error" and that the use of the term "about" 160,000 IU coupled with the range of error already inherent in the specific activity limitation, did not distinguish the invention over close prior art, which described preparations of 120,000 IU, or permitted one of ordinary skill in the art to know what specific activity values below 160,000 IU might constitute infringement. Id. at 1217. The claims as filed included the limitation "at least 120,000." After the examiner rejected the claims because the prior art included EPO having a specific activity of 128,620
IU, the claims were amended to change the "at least 120,000" language to "at least about 160,000" to avoid the cited prior art.

Because the term "about" did not give any indication as to which numerical value between the prior art specific activity value of 128,620 and 160,000 constituted infringement, the court held the term "at least about" to be indefinite. Id. at 1218. The district court further observed that there was nothing in the specification or prosecution history that provided any indication as to what range of specific activity was covered by the term "about," and no expert testified as to a definite meaning for the term. For those reasons, we affirmed the district court’s determination of invalidity, stating that when the meaning of the claims is unclear, especially when there is close prior art, the claims properly may be held to be invalid. Id.

Unlike the situation in Amgen, here the intrinsic evidence does provide guidance on the meaning of the term "near." When intrinsic evidence resolves the claim construction, a term is not "insolubly ambiguous," and thus reference to the prior art is not needed. That is the situation here. In addition, there were no office actions issued by the PTO during the original prosecution rejecting the claims over the prior art. There were also no amendments or arguments filed by the patentee. Thus, unlike in Amgen, the claims were not amended to include vague language in order to overcome close prior art.