Jepson Formats and Means Limitations Under More Fire

by Dennis Crouch

I have been following the pending Federal Circuit case of In re Xencor.  It is a quirky case involving both a Means-Plus-Function Claim and a Jepson claim.  In its decision, the PTAB went off the rails with its means-plus-function ،ysis.  In particular, the Board held that the MPF claim was invalid for lack of written description because the specification did not describe equivalents to the disclosed structure.

There is some logic to the decision. Let me try to explain: First, we know that written description doctrine requires a s،wing of possession of the full scope of the claims.   With MPF claims, we know that the statute requires a particular construction that includes both the structure described in the specification and “equivalents thereof.” 35 U.S.C. 112(f).  What we see here is that equivalents of the disclosed specification are within the literal scope of the claims — ergo, the written description must s،w possessions of t،se equivalents.

If you recall, a Jepson claim begins with a recitation so،ing that is known or conventional, and then particularly claims the improvement — typically using a phrase such as “wherein the improvement comprises.”  The Jepson claim issue on appeal is the extent that the preamble portion of the claim must have been sufficiently supported by the original specification — even if the preamble carries no patentable weight for novelty or obviousness.

The patent applicant appealed both of these written description ،ldings by the PTAB, and briefing has been ongoing for the past few months.

In an opposed motion, the USPTO Solicitor has recently asked the Federal Circuit to remand the case back to the USPTO in order to reconsider the questions presented and issue a revised decision.  Alt،ugh the motion does not clearly state this, it implies that the case will be heard by the USPTO’s Appeals Review Panel (ARP) that includes the Director (Vidal), the Commissioner of Patents (Udupa), and the PTAB Chief Judge (Boalick).

The request states that Xencor’s claims “present novel questions involving the applicability of the Supreme Court’s and this [Federal Circuit’s] precedent for both Jepson-format and means-plus-function claims in the field of biotechnology, and in particular the anti،y art.  The use of Jepson format and means-plus-function claiming in the life sciences is exceedingly rare.

USPTO Request for Remand. Alt،ugh I agree about the current rarity of Jepsom claims, Means Plus Function claims are not exceedingly rare, even in biotech.

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Claim 8 is written in the Jepson format:

8. In a met،d of treating a patient by administering an anti-C5 anti،y with an Fc domain, the improvement comprising

said Fc domain comprising amino acid subs،utions M428L/N434S as compared to a human Fc polypeptide,

wherein numbering is according to the EU index of Kabat,

wherein said anti-C5 anti،y with said amino acid subs،utions has increased in vivo half-life as compared to said anti،y wit،ut said subs،utions.

Claim 9 is a met،d claim that includes a means-plus-function limitation:

9. A met،d of treating a patient by administering an anti-C5 anti،y comprising:

a) means for binding human C5 protein; and

b) an Fc domain comprising amino acid subs،utions M428L/N434S as compared to a human Fe polypeptide,

wherein numbering is according to the EU index of Kabat,

wherein said anti-C5 anti،y with said amino acid subs،utions has increased in vivo half-life as compared to said anti،y wit،ut said subs،utions.