My feeling (informed, but not rigorously researched until a post later this week), is that enablement is slowly overtaking 101 as the vehicle of choice to attack the overreaching patent.
Preemption is no longer the watchword it once was in 101 jurisprudence (Impact Engine actually filed a petition for cert a couple months back asking "Whether the lodestar for determining patent eligibility under this Court’s two-step framework is whether the patent claims preempt basic technological or scientific building blocks").
At the same time, enablement is on a bit of an upswing following the Supreme Court's decision in Amgen Inc. v. Sanofi, 598 U.S. 594,610 (2023) which reaffirmed the general principle that "if an inventor claims a lot, but enables only a little, the public does not receive its benefit of the bargain."
A few weeks ago, Judge Connolly gave us one of the more interesting decisions in this vein, when he granted a motion for summary judgment of no enablement in Spinal Generations, LLC v. Depuy Synthes, Inc., C.A. No. 22-1368-CFC, D.I. 220 (D. Del. Apr. 11, 2025). The patents there covered a "method and device for delivering medicine to bone." (eds. note -- pretty cool title for a patent). In particular, the relevant claims required a "delivery pathway for [a] substance between at least one end of the insert and a portion of the bone."
To break it down a bit, you've got an "insert" (e.g., a needle), going into a bone. The insert has two ends, the distal one going into the bone, and the proximal one that the doctor holds. there's a hole in the needle that medicine can come out of. In one position, it's covered by a screw, so no medicine comes out. in the second position, its not covered so there's a "pathway between at least one end of the insert and a portion of the bone" for the medicine to go out.
The problem is the "at least" part. Obviously, the medicine is pretty much always going to be coming from the end the doctor holds, rather than the end sticking into your bone. So the patent didn't describe any way to configure a device so that medicine came from the other - distal - end. The defendants thus moved for summary judgment, arguing that the patent only enabled a pathway from the "proximal" despite claiming pathways from both ends.
Judge Connolly agreed:
Because the #337 patent undisputably does not teach a delivery pathway between the distal end of the insert and the patient's bone, it does not teach a delivery pathway from both ends of the insert and, therefore, does not teach the full scope of the claimed inventions. That deficiency makes it invalid for lack of enablement as a matter of law. The #572 patent is similarly invalid, as it undisputably does not teach a delivery pathway between the distal end of the bone screw and a bone-screw fenestration, and thus does not teach a delivery pathway between both ends of the bone screw and a bone-screw fenestration.
Id. at 7
Plaintiff responded that the "at least" language did not alter the scope of the claims, in part because it was obvious that the medicine would have to come from the proximal end. But Judge Connolly rejected this argument as well (with a pun!)
Spinal also argues that it would be "utterly impractical" and "nonsensical" to deliver a substance (i.e., bone cement) to the bone from the distal end of the insert. That may be true, but it begs the question-why then did Spinal include the words "at least" in the asserted claims? Having chosen to claim "at least one end" instead of"one end" of the insert in the #337 patent, Spinal increased the scope of its claims to cover second positions with inserts that provide delivery pathways between both ends of the insert and the bone. And having chosen to claim "at least one end" instead of "one end" of the bone screw in the #572 patent, Spinal increased the scope of its claims to cover second positions with inserts that provide delivery pathways between both ends of the bone screw and a bone-screw fenestration. It thus enabled itself (again, pardon the pun) through the exercise of the monopoly rights that come with a patent to exclude others from making and using devices and systems that employ second positions with pathways between both ends of the insert and bone and both ends of the bone screw and a bone-screw fenestration. But because the patents do not enable those pathways, the claims in which those pathways are elements are invalid as matter of law.
Id. at 8-9
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