Category Archives: Education

Supreme Court Sizes Up the Genus – Enablement

The Supreme Court of the United States (SCOTUS) is set to hear arguments on Monday, March 27, 2023 for Amgen v. Sanofi.

ACS’s Chemistry and the Law (CHAL) Division weighs in

The American Chemical Society’s Chemistry and the Law (CHAL) division filed an Amicus brief supporting Amgen’s petition and reversing the Federal Circuit’s decision. Indeed, the resolute CHAL even petitioned the court to get 5 minutes to participate in arguments.

Stay Tuned!

Amgen Inc. v. Sanofi – SCOTUSblog

Amgen’s X-Ray crystallography studies of antibodies 21B12 & 31H4 bound to PCSK9

Subject Matter Eligibility of a Chemical Process

The USPTO, provides an example of a patent-eligible claim for a process of hydrolyzing fat molecules into free fatty acids and glycerol without using conventional methods (at the time of invention) of steam distillation with lye or sulfuric acid. [May, 2016]

May 2016 Update: Subject Matter Eligibility Examples: Life Sciences (May 6, 2016)

Example 33 “Hydrolysis of Fat” – From the USPTO’s Subject Matter Eligibility Examples: Life Sciences

The USPTO based the following “patent eligible” claim on technology from US Patent 11,766, which was upheld by the Supreme Court in Tilghman v. Proctor, 102 U.S. 707 (1881).  Although the case is very old, the USPTO notes that Supreme Court has subsequently described the decision as upholding the eligibility of process claims containing a law of nature. See, e.g., Parker v. Flook, 437 U.S. 584, 590-91 and n.12 (1978); Gottschalk v. Benson, 409 U.S. 63, 70 (1972).

Claim    1.   A process for obtaining free fatty acids and glycerol from fat comprising:

(a) mixing substantially equal quantities of fat and water in a closed vessel; and

(b) heating the mixture to an elevated temperature of at least 600 degrees Fahrenheit under sufficient pressure to prevent the formation of steam in the closed vessel; and maintaining the elevated temperature for at least 10 minutes.

USPTO Analysis

Although the claim is founded upon a chemical principle relating to neutral fats, the claim is eligible because, it is not attempting to tie up the chemical principal so that others cannot practice it.  Even if the claim were directed to a judicial exception, the claim amounts to something “significantly more” than any exception.  The claim would amount to something “significantly more” because the claim recites specific unconventional steps.

Do Inventors Need to Know “Why” Their Inventions Work? No.

To obtain a valid patent, does an inventor need to know why his invention works? Hal Wegner reminds us in his blog that the answer is “no.”

Wegner’s Writings

Going back a bit to 1911, the Supreme Court in Diamond Rubber stated:

“A patentee may be baldly empirical, seeing nothing beyond his experiments and the result ***. It is certainly not necessary that [the inventor] understand or be able to state the scientific principles underlying his invention ***.”

Diamond Rubber Co. v. Consol. Rubber Tire Co., 220 U.S. 428, 435–36 (1911) (citations omitted)

Example for Organic Chemist Inventors:

If you have invented a new compound, the new compound must be “useful.”  You may still be able to get a patent on it even if you haven’t nailed down its mechanism of action.  You may show that is useful in an enzymatic assay.  But you do not need to prove exactly how or where the molecule binds to the target enzyme.