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21 May 2024NewsBiotechnologyLiz Hockley

USPTO appeals panel cements key claims position in antibody case

ARP maintained rejection of two claims of Xencor’s antibodies patent application | Panel clarified specification for means-plus-function claim limitations.

The Appeals Review Panel (ARP), introduced by the US Patent and Trademark Office (USPTO) in 2023, has shed light on the office’s position on Jepson-type claims and means-plus-function claims through its review of an antibodies patent application from biotech Xencor.

A Jepson claim is a type of patent claim that describes an improvement to an existing invention. It starts with a statement about the current state of the art, followed by the phrase “the improvement comprising” and a description of the claimed patentable improvement.

In last week’s decision, which was post-dated May 21, the panel maintained the Patent Trial and Appeal Board’s (PTAB) rejection of two claims of Xencor’s US patent application number 16/803,690, while reversing the examiner’s rejection of the same claims on different grounds.

Antibodies patent splits opinion

Xencor’s ‘690 application relates to antibodies—specifically optimised IgG immunoglobulin variants—engineering methods for their generation, and their application, particularly for therapeutic purposes.

It has a complex procedural history. In March 2021, the examiner rejected claims 8 and 9 of the application for written description and obviousness-type double patenting.

In December that year, following Xencor’s appeal, the examiner withdrew the written description rejection of the claims.

However, in January 2023, the PTAB entered new grounds of rejection for lack of adequate written description, and indefiniteness.

Xencor appealed, and in November last year the PTAB requested an ARP to clarify the office’s position on the proper analysis of “Jepson-format and the means-plus-function claims in the field of biotechnology, and particularly in the antibody art”.

Preamble of Jepson claim ‘limiting’

The ARP, comprised of Vidal, Commissioner for Patents Vaishali Udupa and Chief Administrative Judge Scott Boalick, held that for means-plus-functions claims, it was not necessary to describe equivalents of the structure disclosed in the specification to meet the definiteness or written description requirements.

Claim 8 of the ‘690 application is in Jepson form.

On this matter, the ARP said that it found “the entire preamble of claim 8 to be limiting, and therefore the entire preamble requires written description”.

The panel also found that aside from the Jepson form of the claim, the phrase “treating a patient” in claim 8 should be construed as limiting and lacked written description support.

“We further determine that ‘treating a patient’ means ‘treating all patients and all diseases’,” the panel wrote.

The ARP maintained the board’s written description rejections of claims 8 and 9; did not maintain its indefiniteness rejection of claim 9; and reversed the examiner’s obviousness-type double patenting rejection of claims 8 and 9.

Commenting on the decision, Dennis Crouch, law professor at the University of Missouri School of Law, wrote: “This decision restores power to the idea that MPF [means-plus-function] claims can be used to cover a broader scope even when equivalents are not available.”

It also emphasises the need for patent claims to align with the inventor’s contribution described in the specification, he said, and highlighted “the ongoing challenges biotech innovators face in obtaining method of treatment claims” despite the clarity from the ARP.

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