Purposeful Claims: Morse, Halliburton & Amgen

by Dennis Crouch

Within the patent context, useful limitations describe innovations when it comes to their operate or meant use, relatively than their particular construction or parts. Such claims have been topic to a lot debate and litigation all through the historical past of the US patent system. Notable Supreme Court docket instances 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 apply and the steadiness between useful and structural declare drafting.

The pending Supreme Court docket case of Amgen Inc. v. Sanofi, No. 21-757 (2023) is one other instance, with the potential to additional shift the panorama concerning useful declare limitations. The title of my essay on the case following oral arguments, “Bye Bye Purposeful Claims,” hints at my outlook. Though the patentee targeted 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 masking any technique of transmitting info utilizing electromagnetism, no matter the equipment used. Morse’s declare comprised a single aspect – using electromagnetism to speak at a distance. It’s comprehensible why Morse desired such a useful declare, because it supplied 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 special method or construction.

In O’Reilly v. Morse, the Supreme Court docket deemed the useful declare too broad and thus invalid, establishing that patent claims must be restricted to the particular means or equipment invented relatively than claiming any means for attaining a selected operate. On the identical time, the Court docket upheld Morse’s narrower claims that had been restricted to the particular telegraph equipment he had invented.  Id. See additionally Corning v. Burden, 56 U.S. 252 (1853) (“He can’t describe a machine which is able to 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 aspect. As an alternative, the brand new mannequin of claims recited a mix of components or steps, with a number of particular person parts described functionally. This method encountered one other hurdle in 1946 with the Supreme Court docket’s Halliburton v. Walker determination.

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

The language of the declare thus describes this most vital aspect within the “new” mixture when it comes to what it would do relatively than when it comes to its personal bodily traits or its association within the new mixture equipment. We have now 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); Common Electrical Co. v. Wabash Equipment Corp., 304 U.S. 364 (1938).  GE supplied extra 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 instances by introducing what’s now 35 U.S.C. 112(f), permitting patentees to assert a component of an invention “as a method or step for performing a specified operate with out the recital of construction, materials, or acts in assist thereof.” Nonetheless, 112(f) is extra of a entice than a panacea for patentees. Whereas the ensuing useful declare might 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, underneath the regulation, a means-for limitation is permitted in patents – even on the level of novelty – however it will likely 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 mirror Congress’s intent to allow element-by-element useful limitations in instances like Halliburton, however not wholly useful claims (single-element useful claims) similar to 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 prime 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 Court docket doesn’t declare the amino acids by sequence or by any structural aspect. Quite, the novel function claimed is just its functionality to bind to a selected epitope of an antigen (PCSK9) and consequently assist 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’ll be able to see from the declare language, the important thing novel function of the invention is claimed when it comes to what it does (“binds to PSCK9”) relatively than what it’s (a selected amino acid sequence).  This can be a basic useful limitation.  And, it’s carefully parallel to the single-element declare design rejected in Morse.   There may be some factual debate within the case concerning the variety of antibodies lined 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 Court docket 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 might be to invalidate the declare.
3. However, if the courtroom suits the declare throughout the scope of 112(f), then the scope might be restricted to solely the constructions truly disclosed and their equivalents. That end result would possible result in a non-infringement for Sanofi whose competing product is structurally totally different.

Oral arguments within the case had been held in March and I anticipate a choice from the Court docket in late Could or early June 2023.