Ex parte Lazzara

Informative decision only: persuasive authority, not binding precedent. When a pending claim uses a term of degree such as "substantially uniform" and neither the claims, the specification, nor record evidence supplies a standard for measuring that degree, the Board may reject the claim as indefinite under 35 U.S.C. § 112, second paragraph, even though Federal Circuit infringement cases construed similar terms by ordinary meaning. The standard need not be numerically specific, but it must be derivable from information in the patent about the purpose of the invention (or the aspect to which the term applies) and from experimentation, and during prosecution the burden to define the invention precisely is on the applicant. No prior precedent directly addressed this issue within the text; the Board instead declines to read Federal Circuit post-grant claim-construction cases (Cordis, Ecolab) as a per se rule that "substantially" is always acceptable if given its ordinary meaning. For an examiner, the decision supports a § 112, second paragraph rejection of a term of degree where the record supplies no measuring standard, and it ties the analysis to Seattle Box and Medrad. For an applicant, a dictionary-style ordinary meaning, a description lacking a numerical definition, or a declaration offered for another purpose will not suffice; the applicant must point to a standard in the claims, specification, or expert evidence, or amend the claims. The Board relied on Seattle Box Co. v. Indust. Crating & Packing, Inc., 731 F.2d 818 (Fed. Cir. 1984), Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313 (Fed. Cir. 2005), and In re Morris, 127 F.3d 1048 (Fed. Cir. 1997), on the applicant's burden during prosecution. LEGAL TEST OR STANDARD: When a term of degree is used, there must be some standard by which one of ordinary skill can measure the degree so as to understand what is claimed. The standard need not be defined with numerical specificity, but it must be derivable from information in the patent regarding the purpose of the invention, or of the specific aspect to which the term applies, as well as from experimentation (Seattle Box). The Board also looked to the remainder of the claim language, the specification, and expert testimony (Medrad). TRIGGERING FACTS: Pending application claims recited a "substantially uniform array of irregularities" on a roughened or acid-etched dental implant surface. The claims' stated purpose of facilitating osseointegration did not set an upper bound on nonuniformity, since a roughened surface with widely varying irregularities might also facilitate osseointegration. The specification gave no measure of enhancement, and the appellants' own examples showed wide height variances. The declaration was offered only to compare the claimed surface with prior art and did not say how a skilled artisan would understand the term. The appellants argued that Federal Circuit infringement cases accepted "substantially uniform". KEY QUOTE: "Rather, the case law requires some sort of standard by which one of ordinary skill in the art can measure a term of degree such as "substantially" so as to understand what is claimed." (p. 3) PRIOR PRECEDENT AFFECTED: No prior Board precedential or informative decision is directly affected. The Board followed Seattle Box Co. v. Indust. Crating & Packing, Inc., 731 F.2d 818 (Fed. Cir. 1984), and Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313 (Fed. Cir. 2005), and distinguished Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352 (Fed. Cir. 2003), and Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358 (Fed. Cir. 2001), as post-grant infringement cases. PRACTICE TIP: When a claim uses a term of degree, do not rely on Federal Circuit litigation cases that give "substantially" its ordinary meaning. Identify in the claims, specification, or expert declaration a concrete standard (such as a purpose-based bound or a measurement) that tells a skilled artisan the degree permitted, or amend the claim, because the applicant bears the burden of precise definition during prosecution.