The recent decision, about a backbone stabilizing device, in Cross Medical Prods. v. Medtronic Sofamor Danek [1], 424 F.3d 1293 (Fed. Cir. 2005), may be a reminder why so many commentators have weighed in on the need to reform the Patent Act, or to reign in judicially-created rules.
The panel decision in Cross Medical works out on the rebuttable presumptions for and against imposing a “means” construction on claims, the yielding “doctrine” of claim differentiation, that extrinsic “marking estoppel” cannot contradict intrinsic interpretative evidence, then “refer[ing] to the dictionary” first to determine ordinary meaning, and also, ruling as a MOL what one of ordinary skill would have understood “from the context of” the specification, but that whether “a set screw is equivalent to an external nut” cannot be decided “as a matter of law,” and noting that an infringer’s later admission of interchangeability is “irrelevant to known interchangeability” at the time of invention. The Federal Circuit has fathered all of these presumptions and doctrines and tools for ruling, and applies them decisively. However, these rules of decision have little of no basis in the patent statute.
The two aspects of the Cross Medical case, infringement and obviousness, should be read by clients and patent attorneys who have medical device patents and applications.
The ruling of no direct infringement results from including the “bone” in the claim for the bone “fixation device.” Without the presence of the “bone” in the accused infringing device, no direct infringement occurs until it is implanted. “Because Medtronic does not itself make an apparatus with the ‘interface’ portion in contact with bone, Medtronic does not directly infringe.” The issue then turns to inducement to infringe and to contributory infringement, but again, one essential element of those is direct infringement. In addition, proof of ‘knowingly” inducing and of “no substantial non-infringing use” must be presented to sustain those charges.
Putting aside the correctness of the non-infringement ruling, you can find a fair number of recently-issued patents for medical devices (which I’ll leave unidentified) that claim the “bone” or the “tissue” that the medical devices acts upon, even though many patents follow the better practice of mentioning, but not claiming, the “bone” itself, e.g., US Pat. 6,342,055 [2]. As we were taught early on – don’t include the “work piece” in what is claimed. To do so may prevent a finding of direct infringement and relegate to the case to the common-law doctrine of inducing or contributing to infringements.
Obviousness may be the next battleground in the patent law, in part due to the certiorari petition in KSR Int’l v. Teleflex [3], which makes well-supported arguments that the Federal Circuit requirement for clear and convincing proof of a “motivation or suggestion” to combine prior art references has no basis in the law.
The decision in Cross Medical applies a lower standard, and bases its ruling on the principle that the “motivation to combine” may be “implicit” in the skill of one skilled in the art, and that it can come from one’s knowledge of the problem to be solved, or of a different problem. “One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.” Perhaps I fail to grasp the logic of these statements about what can prove obvious combinations. Instead, the ruling may cut against patents in crowded fields of art, such as medical devices, where each advance is engendered from highly-skilled persons “knowledge of the problem to be solved.” The absence of a proven “motivation or suggestion” in the prior art often is essential to medical devices that claim am advantageous combination of known elements
In the coming year, patent practitioners will hear about reforms to the patent act, which are intended to make for “better” patents and for more predictable patent rulings, and may hear too from the Supreme Court about the long-standing, but non-statutory, test for obviousness. Perhaps some development in those areas may help in the future to cut down the issues in a case like Cross Medical.
Today’s post comes from Guest Barista C. Lee Thomason [4], a registered patent attorney and IP litigator at Frost Brown Todd’s [5] Louisville office.