CAFC: Prior Art Requires Written Support for Jepson Claim

Today, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in In re: Xencor, Inc. affirming the Appeals Review Panel (ARP) of the Patent Trial and Appeal Board (PTAB), which rejected of claims from a Xencor patent application as unpatentable. This descriptive characterization of what transpired is not particularly shocking—it is hardly breaking news for the Federal Circuit to affirm the PTAB or the ARP, thereby rendering patent claims dead. But if you dig a little deeper at least one aspect of the ruling is nearly breathtakingly appalling. The Federal Circuit agreed with the ARP that Xencor’s Jepson claim preamble lacked written description support in the specification, which rendered the claim unpatentable.

Jepson claims are famously limiting and are typically disfavored in the United States among most clients and practitioners because they are so limiting. Of course, the reason that a Jepson claim is limiting is because everything in the preamble is admitted as being in the prior art, with the claimed innovation being limited to what comes after the transition, which is generally some form of express admission in the form of: “wherein the improvement comprises.” Thus, it is easy to understand why the preamble of a Jepson claim is limiting and admitting what comes before is in the prior art—because the applicant is admitting that only what comes after the transition is an improvement.

Effective today, the Federal Circuit says that you must disclose and describe the prior art, or your Jepson claim is invalid. Obviously, this means that pretty much every Jepson claim in existence is now invalid. It also ensures that Jepson claims will never be used again. If Jepson claims are both extremely limiting and extremely fragile, they simply cannot be used ever again, period.

It is also a mystery why the Patent Office would ever want a decision like this. I suppose it is understandable as to why the Solicitor’s Office defended the ARP, which includes the Director of the USPTO, the Commissioner for Patents, and the Chief Judge of the PTAB, but advocating in favor of requiring the prior art to be disclosed, discussed and supported in a Jepson claim is precisely contrary to the intent of the rules themselves. As many practitioners no doubt know, the Office prefers Jepson format and Rule 1.75(e) specifically encourages Jepson claim format, going so far as to say whenever possible, “as in the case of an improvement”, an independent claim should be written in Jepson format.  Why the Office has previously encouraged Jepson claims is easy to understand—they are easier for the examiner because they specifically and precisely identify what the applicant believes the improvement is and limits examination to only what the applicant specifically admits is the only thing to distinguish over the prior art. What the ARP was thinking is harder to reconcile with thoughtful examination policy.

But it gets worse. To justify this lunacy the Federal Circuit actually pointed out that a patentee cannot obtain a Jepson claim with a preamble that includes a time machine without describing a time machine! Of course you can’t get a Jepson claim on a time machine! You also can’t get a Jepson claim on a unicorn, teleportation device (i.e., the Star Trek transporter), or a method of traveling faster than the speed of light. The CAFC pointing out that you cannot get a Jepson claim on things that are purely fictional, like a time machine, is hardly insightful and comes across as entirely ridiculous, desperate and at least a little bit insulting. You can’t get any kind of claim on a time machine, unicorn, transporter or method of traveling faster than light because they do not exist.

How the Jepson Claim Debacle Unfolded

In February 2020 Xencor filed a patent application with the U.S. Patent and Trademark Office claiming priority to February 2008 and claiming methods of treating a patient by administering an anti-C5 antibody, which binds human C5 protein and provides anti-inflammatory effect that has been researched for its potential use in treating asthma and transplantation. The specification of the filed patent application discloses that antibodies for amino acids, which require multiple injections over long time periods, are frequently involved in the treatment of autoimmune diseases because they can be administered over fewer treatments.

Having disputed patent examiner conclusions on whether certain claim preambles were limiting through the entire ex parte appeals process, Xencor received a decision from ARP in May 2024 finding that claims 8 and 9 of the patent application lacked sufficient written description support in the specification. Claim 8, which includes the Jepson claim preamble that recites “treating a patient by administering an anti-C5 antibody with an Fc domain”, was not supported because the specification did not provide a representative number of species of the claimed genus of anti-C5 antibodies. This same reasoning was applied to claim 9, which includes a similar preamble without the familiar Jepson transition— “the improvement comprising”.

Although the Federal Circuit’s analysis began with claim 9, it’s the appellate court’s ruling on the written description requirement for Jepson claim 8 that will likely create the most controversy. Xencor argued to the Federal Circuit that the written description requirement of 35 U.S.C. § 112 only requires the specification to support the invention as described by the claim language following “the improvement comprising”, which makes all the sense in the world because the exclusive rights provide by a Jepson claim are limited to the specifically identified improvement, not to the underlying and admitted prior art. Unfortunately, agreeing with the ARP that Jepson claim preambles require written description support, the Federal Circuit held that a Jepson claim form limits the improvement by the subject matter of the preamble, which makes the entire invention the claimed improvement as applied to the prior art.

“If we were to accept Xencor’s argument, we would be doing away with the requirement that the written description ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed…’ If an inventor were permitted to simply assert, without showing, that she possessed what is claimed to be in the prior art, she might be able, improperly, to obtain a patent on something she does not actually possess.”

The Federal Circuit further agreed with the ARP that Xencor had not established that the anti-C5 antibodies in the Jepson claim preamble were well-known in the art, finding substantial evidence backing the ARP’s ruling in this regard. Xencor’s position that it did not need to provide written description support for what already existed in the prior art, although perfectly logical and entirely reasonable, was simply not persuasive in the view of the Federal Circuit.

Game Over, Time to Go Home

On the one hand the Federal Circuit has really jumped the shark with this ruling. On some other level, however, this ruling is perfecting in line with where the Federal Circuit is trending. No patent is safe, every claim is vulnerable, and why won’t you people just get the message that we—the Federal Circuit—just don’t like patents anymore.

God help us if we need to start providing written support for the prior art or risk invalidity or unpatentability. We might as well just close shop and go home because the game is over.

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Author: kieferpix
ID 294601918