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 analysis. 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 showing 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 show possessions of those equivalents.
If you recall, a Jepson claim begins with a recitation something 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 holdings 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. Although 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 antibody art. The use of Jepson format and means-plus-function claiming in the life sciences is exceedingly rare.
USPTO Request for Remand. Although I agree about the current rarity of Jepsom claims, Means Plus Function claims are not exceedingly rare, even in biotech.
= = = =
Claim 8 is written in the Jepson format:
8. In a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising
said Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide,
wherein numbering is according to the EU index of Kabat,
wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.
Claim 9 is a method claim that includes a means-plus-function limitation:
9. A method of treating a patient by administering an anti-C5 antibody comprising:
a) means for binding human C5 protein; and
b) an Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fe polypeptide,
wherein numbering is according to the EU index of Kabat,
wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.
It’s just a misreading of 112f. “An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.”
The phrase “in the specification” obviously modifies “structure, material or acts” that “correspond[s]” to “[the] specified function.” There is no requirement that “equivalents” be disclosed in the specification. The only real way to read 112f in harmony with 112a is that “equivalents” extends to the boundary of the ordinary creativity of the PHOSITA based on the disclosed “structure, material or acts” and therefore is inherently met by a definite 112f disclosure.
I actually agree with the solicitor that it is a novel question, I just think the rule they generated cannot be the correct one. I think there may be some disclosures that have a null set of equivalents, but assuming there is definite structure in the spec I think 112a/b are inherently met.
In other words, if a structure performing a function is disclosed, a person of ordinary skill applying ordinary creativity can create some number of similar structures that achieve similar results in similar manners. That number may or may not be zero. But regardless of if it is zero or not, the set is inherently enabled because it requires only the application of ordinary creativity to the already-disclosed structure. It is inherently possessed because a PHOSITA can reasonably believe possession of embodiments that require no supercreative work. It is inherently definite because the claim scope is set by statute. It is proper to bring the ordinary skill and conventional knowledge of the PHOSITA into the analysis because the statute only requires that the specification disclose the structure, not the equivalents of the structure.
i.e. The “worst” result could be that that there are no equivalents – that a person of ordinary skill after reading the disclosed structures could think of no similar structures to achieve a similar result in a similar way. That would limit the claim reach to the specification-disclosed embodiment, but that embodiment would be enabled, possessed and definite. Conversely, if there are equivalents they are equivalents because a person of ordinary skill would find them without nonobvious thought or undue experimentation and consequently those embodiments are enabled, possessed and definite as well. The board errs by requiring the specification to list embodiments when the statute does not require the specification to disclose it, it only requires the specification to demonstrate possession. You always demonstrate possession of equivalents.
Agree.
What is more unusual here is for the PTO Director, through her attorneys in the Solicitors Office, to file a motion for the Fed. Cir. not to take this ex parte appeal and instead return it back to the PTAB for further review of 112 re these Jepson and M-F claims. But unless the disputed claims get allowed by that [member-expanded-by-statute] review, I would think this case will be back to the Fed. Cir. for its own views, which may well differ?
You state “pending Federal Circuit,” but then you say “PTAB.”
So I take it that this is at the Federal Circuit through an appeal of a PTAB decision (IPR? PGR? Reissue? other?)….
The subject hotlinked motion [and the issue being 112] shows that this is an ex parte rejection of application claims.
Thanks Paul – the hotlinked motion did not explicitly state that.
It references an Examiner’s rejection, but that can take any number of ‘shades,’ without definitively providing the actual posture of the case.
“means for binding human C5 protein”
Weird.
Maybe the USPTO means that—in combination—Jepson and MPF are unusual? That I would tend to believe.
Certainly, as can be seen by the (finally) updated Jepson claim format tracking post, most anything in combination with Jepson would be unusual.
I agree. Also, the USPTO wrote that sentence leading with Jepson, not MPF, so the former was probably more front and center in their collective “mind” when they made the “exceedingly rare” comment.
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