Patent Eligibility

§101 – Patent Eligibility

[Updated January 20, 2017 –  Please check back for updated material.]

Statute: 35 U.S.C. 101 –  Inventions Patentable.

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

Patent Eligibility vs. Patentability

  • “Patent Eligibility” relates to the subject matter of an invention.
  • “Patentability” relates to whether the invention is novel and non-obvious.

Patent Eligible Subject Matter &Exceptions

  • The law [§101] imposes “a threshold test,” of patent eligibility of the claimed subject matter. [See Bilski v. Kappos, 561 U.S. 593, 602 (2010).]
  • Patent eligible subject matter:
    • Inventors may be able to patent a new & useful: (1) Process, (2) Machine (3) Manufacture, or  (4) Composition of matter
  • Exceptions: Abstract Ideas / Natural Phenomenon / Law of Nature
    • The U.S. Supreme Court developed the doctrine of judicial exceptions to patentable subject matter. Judicial exceptions include Abstract Ideas, Natural Phenomenon, and Laws of Nature.
    • Determining Patent Eligibility:
      • The Supreme Court developed a two-step test:

(1) –      Is the claim a process, machine, manufacture or composition of Matter?

(2A) –    Is the claim directed to an abstract idea, law of nature or natural phenomena?

(2B) –    Is there an inventive concept that makes it into something significantly more?

See Alice Corp. v. CLS Bank 134 S.Ct. 2347 (2014); No. 13–298. and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)

Patent Eligibility in Biotechnology

Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 569 U. S. __ (2013 [No. 12-398)]

  • NOT Patent Eligible = Isolated genes are natural phenomena.
  • Patent Eligible = Lab-generated cDNA is eligible, even though it is produced from isolated genes (i.e. natural phenomena), with the addition of only conventional, routine steps.

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.

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.

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.

fatty-acid-figure-1

Patent Eligibility of Nature-Based Products

UPSTO Patent Eligibility Example #2. Pomelo Juice:

  • Process claim that is directed to an exception; and
  • Product claim that is NOT directed to an exception.

This example illustrates the eligibility analysis of a process (claim 1) that focuses on a nature-based product and a product (claim 2) that is nature-based but is not directed to an exception because it has markedly different characteristics from its naturally occurring counterpart.

Background: The pomelo tree (Citrus maxima) is a naturally occurring tree that is native to South and Southeast Asia. Pomelo fruit is often eaten raw or juiced, and has a mild grapefruit-like flavor. Naturally occurring pomelo juice spoils over the course of a few days even when refrigerated, due to the growth of bacteria that are naturally present in the juice. The specification indicates that suitable preservatives for fruit juices are known in the art, and include naturally occurring preservatives such as vitamin E, and non-naturally occurring preservatives such as preservative X. The specification defines an “effective amount” of these preservatives as an amount sufficient to prevent juice from spoiling for at least three weeks, e.g., by retarding the growth of bacteria in the juice.

Claims:

  1. A method comprising providing a pomelo fruit.
  2. A beverage composition comprising pomelo juice and an effective amount of an added preservative.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All the claims are directed to a statutory category, e.g., a process or composition of matter (Step 1: YES).

Claim 1: Ineligible. Although the claim is a process claim, it has been drafted such that there is no difference in substance from a product claim to the pomelo fruit itself. Accordingly, this process claim is focused on the pomelo fruit per se (a nature-based product), and must be analyzed for markedly different characteristics, to determine whether the claimed pomelo fruit is a “product of nature” exception. There is no indication in the specification that the claimed fruit has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring fruit provided by pomelo trees. Thus, the claimed fruit does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.

Claim 2: Eligible. Because the claim is a nature-based product, i.e., a combination of a naturally occurring substance (pomelo juice) with an added preservative, the nature-based combination is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. In this case, there is no naturally occurring counterpart to the claimed combination, so the combination is compared to the individual components as they occur in nature. The specification indicates that the preservative can be natural or non-natural in origin, but that regardless of its origin, when an effective amount of preservative is mixed with the pomelo juice, the preservative affects the juice so that it spoils much more slowly (spoils in a few weeks) than the naturally occurring juice by itself (spoils in a few days). This property (slower spoiling) of the claimed combination is markedly different from properties of the juice by itself in nature. Accordingly, the claimed combination has markedly different characteristics, and is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.