Chapter §4.02 Undue Experimentation
| Jurisdiction | United States |
§4.02 Undue Experimentation
[A] Wands Factors Framework
Case law has engrafted an undue experimentation qualifier onto the enablement requirement as set forth in 35 U.S.C. §112, ¶1.52 A patent application will be considered enabling so long as the disclosure permits the hypothetical person skilled in the art to make and use the invention "without undue experimentation."53 That the art worker might have to conduct some experimentation to make and use the invention as broadly as it is claimed is not fatal. "[A] reasonable amount of routine experimentation required to practice a claimed invention does not violate the enablement requirement."54 Only when the degree of experimentation becomes undue has the patent application or patent failed to meet the enablement requirement.55
For example, the experimentation necessary to carry out a patented numerical control system for machine tools in White Consol. Indus., Inc. v. Vega Servo-Control, Inc.,56 was sufficiently burdensome that the Federal Circuit affirmed a district court's holding of invalidity based on noncompliance with the enablement requirement. The record reflected that the claimed system could be carried out only by obtaining access to software maintained as a trade secret or independently writing software code that would have required 1.5 to 2 person-years of effort.57
The Federal Circuit contrasted the undue experimentation required in White Consol. Indus. with the "considerable direction and guidance" provided by the specification of the patent in suit in PPG Indus., Inc. v. Guardian Indus. Corp.58 PPG's patent was directed to solar control glass for automobiles. Its specification described "in ample detail" how to make and use the invention with respect to seven specific embodiments set forth in experimental examples. Validity challenger Guardian focused on a software error that PPG had discovered in its glass testing equipment. Due to that error, the computations of ultraviolet transmittance in each of the patent's examples were off by three percent. Although the error made it appear that commercial production of a glass composition satisfying certain transmittance limitations of the claims would be difficult, the Federal Circuit concluded that the error did not violate the enablement requirement. The appellate court highlighted a district court's finding that PPG's calculation error was "harmless, inconsequential, and easily detectable by anyone who was skilled in the art of processing solar controlled glass."59 In light of the guidance provided by PPG's specification, the Federal Circuit concluded that the case before it was "quite different from those in which enablement has been found lacking because of the need for 'undue experimentation.' "60
In a 2013 decision, Cephalon, Inc. v. Watson Pharms., Inc.,61 the Federal Circuit reversed a district court's judgment of invalidity for failure to satisfy the enablement requirement where the proffered evidence of undue experimentation in carrying out a patented method of drug delivery was primarily the accused infringer's expert's "[u]nsubstantiated statements indicating that [the required] experimentation would be 'difficult' and 'complicated.' "62 Although the district court had accorded credibility to the expert, the Federal Circuit determined that his testimony, particularly his "ipse dixit statements,"63 was "largely unsupported, and therefore, carrie[d] little weight in this analysis."64 The expert's opinion that carrying out the claimed invention would be "difficult" and "complicated" could not, as a matter of law, be "enough to constitute clear and convincing evidence" required to invalidate an issued patent.65
Moreover, the Circuit in Cephalon observed that there is "no formal burden-shifting framework when addressing the issue of enablement."66 The district court had determined that the accused infringer Watson had established a "prima facie case" of lack of enablement, and that patentee Cephalon has "failed to rebut" the prima facie case.67 The Circuit responded that "[a]ctually, the burden of proof was Watson's alone."68 Because issued patents are presumed valid, "the challenger bears the burden, throughout the litigation, of proving lack of enablement by clear and convincing evidence."69
A patent application need not disclose what is well known in the art;70 otherwise, patent documents would become product manufacturing specifications, which they are not intended to be. For example, "extensive experimentation does not necessarily render the experiments unduly extensive where the experiments involve repetition of known or commonly used techniques."71 On the other hand, failure to enable the novel aspects or features of an invention can be fatal.72 In a 2017 decision, the Federal Circuit observed that
[t]he boundary between a teaching sufficient to enable a person of ordinary skill in the field, and the need for undue experimentation, varies with the complexity of the science. Knowledge of the prior art is presumed, as well as skill in the field of the invention. The specification need not recite textbook science, but it must be more than an invitation for further research. 73
Whether the degree of experimentation needed to reproduce the claimed invention has become undue, meaning that the enablement requirement has not been satisfied, turns on the application of a number of factors. The Federal Circuit enumerated these factors in In re Wands.74 They include
(1) the quantity of experimentation necessary;
(2) the amount of direction or guidance presented;
(3) the presence or absence of working examples;
(4) the nature of the invention;
(5) the state of the prior art;
(6) the relative skill of those in the art;
(7) the predictability or unpredictability of the art; and
(8) the breadth of the claims. 75
Several of the Wands factors are addressed individually below. The Wands factors should be analyzed by the USPTO examiner during ex parte prosecution of pending patent applications, as well as by federal court litigants challenging the validity of issued patents on nonenablement grounds.76 Not every Wands factor need be reviewed in every enablement determination, however; the factors are considered "illustrative, not mandatory."77 Given the facts of a particular case, some factors may be more relevant than others.78
The Federal Circuit regards compliance with the enablement requirement, and in turn compliance with the requirement that the experimentation required to make and use an invention not be undue, as questions of law.79 The Federal Circuit reviews these ultimate questions de novo. Because the underlying Wands factors are factual in nature, however, the individual factors are reviewed for clear error if found by a district court80 (rather than a jury, the fact findings of which would be reviewed under the "unsupported by substantial evidence" standard81). When found by the USPTO, the factual underpinnings of enablement are reviewed for support by substantial evidence on the entirety of the agency record.82
[B] Predictability of the Technology
[1] Generally Predictable Technologies
Although the enablement analysis is inherently fact specific and differs in every case, one Wands factor very often central to the inquiry is whether the claimed invention is considered to be within a "predictable" or "unpredictable" technology.83 In general, inventions in the mechanical and electrical arts are considered predictable. Based on generally well-understood laws of physics, thermodynamics, and other basic scientific principles, if one embodiment of the invention is adequately described, then persons of skill in the art can predict fairly easily how other embodiments within the scope of the claimed invention could be made and used.84
For example, consider a mechanical invention claimed as "a widget comprising part A attached to part B by means of a fastener." If the patent application discloses that A can be satisfactorily attached to B by means of a common nail, one can predict that other combinations employing a screw, glue, or Velcro® as fasteners would also probably work. At a minimum, a person of ordinary skill in the art of widgets could probably evaluate the feasibility of such alternatives without undue experimentation.
[2] Generally Unpredictable Technologies
The predictive assumption about alternative embodiments in the mechanical arts is generally not made in the case of inventions in the chemical and biotechnological arts. In these technologies, at least certain aspects of which are generally considered unpredictable, a minor change in the physical structure of a molecule or compound can result in major changes in its properties and functions. To be enabling, a patent application directed to these types of inventions must provide a correspondingly greater degree of how-to-make and how-to-use information, in contrast with the disclosure of a simple mechanical device in the example above.
A classic example of an unsuccessful attempt to enable broad claims in an unpredictable art is Amgen, Inc. v. Chugai Pharm. Co.,85 one of the Federal Circuit's watershed biotechnology decisions. The Federal Circuit affirmed a district court's conclusion that Amgen's generic claims, directed to purified and isolated DNA sequences encoding erythropoietin (EPO, a protein that stimulates the production of red blood cells) and host cells transformed or transfected with a DNA sequence, were invalid because the specification did not provide an enabling disclosure commensurate with the broad scope of the claims. The claims "cover[ed] all possible DNA sequences that will encode any polypeptide having an amino acid sequence 'sufficiently duplicative' of EPO to possess the property of increasing production of red blood cells,"86 and thus, "the number of claimed DNA encoding sequences that can produce an EPO-like product is potentially enormous."87 Noting the district court's finding that the technology at...
To continue reading
Request your trial