Useful Claims: Morse, Halliburton & Amgen

by Dennis Crouch

Within the patent context, useful limitations describe innovations by way of their operate or supposed use, fairly than their particular construction or elements. Such claims have been topic to a lot debate and litigation all through the historical past of the US patent system. Notable Supreme Courtroom circumstances like O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1854) and Halliburton Oil Effectively Cementing Co. v. Walker, 329 U.S. 1 (1946) considerably impacted patent follow and the steadiness between useful and structural declare drafting.

The pending Supreme Courtroom case of Amgen Inc. v. Sanofi, No. 21-757 (2023) is one other instance, with the potential to additional shift the panorama relating to useful declare limitations. The title of my essay on the case following oral arguments, “Bye Bye Useful Claims,” hints at my outlook. Though the patentee centered on different points in its briefing, the Justices repeatedly questioned the permissibility of broad useful declare limitations.

Samuel Morse, inventor of the telegraph and Morse code, revolutionized communication. Morse’s 1840s patent included a controversial useful declare overlaying any methodology of transmitting info utilizing electromagnetism, no matter the equipment used. Morse’s declare comprised a single factor – using electromagnetism to speak at a distance. It’s comprehensible why Morse desired such a useful declare, because it offered broader safety in opposition to design arounds. A competitor’s product would infringe so long as it carried out the claimed operate, even when it utilized a distinct method or construction.

In O’Reilly v. Morse, the Supreme Courtroom deemed the useful declare too broad and thus invalid, establishing that patent claims ought to be restricted to the precise means or equipment invented fairly than claiming any means for reaching a specific operate. On the identical time, the Courtroom upheld Morse’s narrower claims that have been restricted to the precise telegraph equipment he had invented.  Id. See additionally Corning v. Burden, 56 U.S. 252 (1853) (“He can not describe a machine which can carry out a sure operate, after which declare the operate itself, and all different machines that could be invented to carry out the identical operate.”).

Put up-Morse, patentees adjusted their method however continued utilizing useful limitations. The Patent Workplace ceased permitting wholly useful claims with a single means-for factor. As a substitute, the brand new mannequin of claims recited a mixture of components or steps, with a number of particular person elements described functionally. This method encountered one other hurdle in 1946 with the Supreme Courtroom’s Halliburton v. Walker resolution.

Walker’s patent addressed an equipment for finding underground strata throughout oil properly drilling utilizing acoustic echo measurements. The patent claims have been written functionally, together with “means speaking with mentioned properly”; “echo receiving means”; and “means … for tuning mentioned receiving means.” US2156519. The Supreme Courtroom concluded that utilizing a useful limitation to say an invention’s point-of-novelty was improper.

The language of the declare thus describes this most vital factor within the “new” mixture by way of what it is going to do fairly than by way of its personal bodily traits or its association within the new mixture equipment. We’ve got held {that a} declare with such an outline of a product is invalid as a violation of Rev. Stat. 4888.

Id. Citing Holland Furnishings Co. v. Perkins Glue Co., 277 U.S. 245 (1928); Basic Electrical Co. v. Wabash Equipment Corp., 304 U.S. 364 (1938).  GE offered further on-point language:

[T]he vice of a useful declare exists not solely when a declare is “wholly” useful, if that’s ever true, but in addition when the inventor is painstaking when he recites what has already been seen, after which makes use of conveniently useful language on the precise level of novelty.

Id.

The 1952 Patent Act not less than partially overturned this line of circumstances by introducing what’s now 35 U.S.C. 112(f), permitting patentees to say a component of an invention “as a way or step for performing a specified operate with out the recital of construction, materials, or acts in help thereof.” Nevertheless, 112(f) is extra of a entice than a panacea for patentees. Whereas the ensuing useful declare could seem broad in isolation, the statute features a tight scope limitation: “such declare shall be construed to cowl the corresponding construction, materials, or acts described within the specification and equivalents thereof.” Thus, beneath the legislation, a means-for limitation is permitted in patents – even on the level of novelty – however it is going to be construed solely to cowl corresponding embodiments explicitly described within the specification and their equivalents.

112(f) has one other function: it solely applies to conditions the place a patentee seeks to functionally restrict particular person components in a multi-element mixture declare. This seems to replicate Congress’s intent to allow element-by-element useful limitations in circumstances like Halliburton, however not wholly useful claims (single-element useful claims) reminiscent of these rejected in Morse. Morse-style single means claims stay unpatentable.  In re Hyatt, 708 F.2d 712 (Fed. Cir. 1983).

Lets return to the Amgen case:  Amgen’s scientists used a humanized mouse mannequin to find a number of monoclonal antibodies helpful as a therapy for top LDL (unhealthy ldl cholesterol). In its specification, Amgen disclosed 26 amino acid sequences (not together with the one utilized by Sanofi) and a technique for creating and screening extra.  The patent earlier than the Supreme Courtroom doesn’t declare the amino acids by sequence or by any structural factor. Somewhat, the novel function claimed is solely its functionality to bind to a specific epitope of an antigen (PCSK9) and consequently help the liver’s pure functionality of breaking down LDL with out PCSK9 interference.

1. An remoted monoclonal antibody that binds to PCSK9 … [and therefore] blocks binding of PCSK9 to LDLR.

US8859741. As you possibly can see from the declare language, the important thing novel function of the invention is claimed by way of what it does (“binds to PSCK9”) fairly than what it’s (a specific amino acid sequence).  It is a basic useful limitation.  And, it’s carefully parallel to the single-element declare design rejected in Morse.   There’s some factual debate within the case in regards to the variety of antibodies coated by the useful declare. The quantity is someplace between 400 and thousands and thousands, relying upon the way you rely.

What are some backside traces for this story?:

1. It’s fairly attainable that the Supreme Courtroom will interpret Amgen’s declare as a useful limitation and go on to think about utility of its prior precedent on level mentioned above.
2. If the courtroom sees the declare as parallel to that in Morse, the response will probably be to invalidate the declare.
3. Then again, if the courtroom suits the declare throughout the scope of 112(f), then the scope will probably be restricted to solely the buildings really disclosed and their equivalents. That outcome would possible result in a non-infringement for Sanofi whose competing product is structurally totally different.

Oral arguments within the case have been held in March and I anticipate a choice from the Courtroom in late Might or early June 2023.