Example 1. Diamond v. Chakrabarty 44 (U.S. Patent No. 4,259,444)

Background:

Stable energy-generating plasmids that provide hydrocarbon degradative pathways exist within certain bacteria in nature. Different plasmids provide the ability to degrade different hydrocarbons, e.g., one plasmid provides the ability to degrade camphor, and a different plasmid provides the ability to degrade octane. Pseudomonas bacteria are naturally occurring bacteria. Naturally occurring Pseudomonas bacteria containing one stable energy-generating plasmid and capable of degrading a single type of hydrocarbon are known.

Representative Claim:

A bacterium from the genus Pseudomonas containing therein at least two stable energy generatingplasmids, each of said plasmidsproviding a separate hydrocarbondegradative pathway.

Analysis:

The claim is directed to a statutory category, e.g., a manufacture or composition of matter (Step 1: YES) and recites a nature-based product (a bacterium). To determine whether the claim is directed to a ‘‘product of nature’’ exception, the nature-based product is analyzed using the markedly different characteristics analysis.

The claimed bacterium has a different functional characteristic from naturally occurring Pseudomonas bacteria, i.e., it is able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon.

The claimed bacterium also has a different structural characteristic, i.e., it was genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The bacterium is new with markedly different characteristics from any found in nature, due to the additional plasmids and resultant capacity for degrading multiple hydrocarbon components of oil. These different functional and structural characteristics rise to the level of a marked difference, and accordingly the claimed bacterium is not a ‘‘product of nature’’ exception. Thus, the claim is not directed to an exception (Step 2A: NO). The claim is eligible.

Example 2. Association for Molecular Pathology v. Myriad Genetics, Inc. (U.S. Patent No. 5,747,282)

Background:

A human gene is a naturally occurring segment of DNA that codes for a protein. In nature, human genes are linked together by covalent bonds to form long chains of DNA called chromosomes. The inventors discovered the location and nucleotide sequence of a naturally occurring human gene called BRCA1. The BRCA1 gene encodes a polypeptide called BRCA1, which helps repair damaged DNA and prevent tumor formation. There are many naturally-occurring mutations in the BRCA1 gene. Some mutations are harmless, but others can dramatically increase a person’s risk of developing breast and ovarian cancer.

Knowledge of the location and nucleotide sequence of the BRCA1 gene allows it to be isolated so that it can be studied, manipulated, or used. Isolated genes can be made in two different ways. The first way is to physically remove the gene from its natural location on the human chromosome by breaking two covalent bonds—one on each end of the gene—that connect the gene with the rest of the chromosome in nature. The second way is to synthesize the gene in a laboratory, e.g., by linking together nucleotides to form the naturally occurring sequence of the gene. Both ways result in a gene that is ‘‘isolated’’ from its natural environment, i.e., removed from the chromosome in which it occurs in nature.

The BRCA1 gene is about 80,000 nucleotides long, including several introns and several exons. In nature, the BRCA1 polypeptide is produced from the BRCA1 gene through an intermediate product called an mRNA. The natural creation of the BRCA1 mRNA in human cells involves splicing (removal) of the introns, and results in an exons-only molecule. The inventors used the mRNA to create an exons-only (cDNA), which contains the same protein-encoding information as the BRCA1 gene, but omits the non-coding portions (introns) of the gene. The nucleotide sequence of this cDNA was disclosed as SEQ ID NO:1, and the amino acid sequence of the BRCA1 polypeptide as SEQ ID NO:2.

Representative Claims:

Claim 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

Claim 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

Analysis:

The claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and recite nature based products (a DNA). Thus, the markedly different analysis is used to determine if that nature-based product is a ‘‘product of nature’’ exception.

Claim 1:

The claim encompasses isolated DNA that has the same nucleotide sequence as the naturally occurring BRCA1 gene. The isolation of the claimed DNA results in a different structural characteristic than the natural gene, because the natural gene has covalent bonds on the ends that connect the gene to the chromosome which the claimed DNA lacks. However, the claimed DNA is otherwise structurally identical to the natural gene, e.g., it has the same genetic structure and nucleotide sequence as the BRCA1 gene in nature. The claimed DNA has no different functional characteristics, i.e., it encodes the same protein as the natural gene. Under the holding of Myriad, this isolated but otherwise unchanged DNA is not eligible because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA1 gene. In other words, the claimed DNA is different, but not markedly different, from its naturally occurring counterpart (BRCA 1 gene), and thus is directed to a ‘‘product of nature’’ exception (Step 2A: YES).

A claim directed to an exception should be analyzed to determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the exception. Claim 1 does not include any additional features that could add significantly more to the exception (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101.

Claim 2:

The claim is limited to a DNA having the nucleotide sequence of SEQ ID NO: 1. As disclosed in the specification, SEQ ID NO: 1 is an exonsonly sequence of a cDNA created by the inventors. The claimed DNA therefore has different structural characteristics than the naturally occurring BRCA1 gene, e.g., in addition to lacking covalent bonds on its ends, it has a different nucleotide sequence (SEQ ID NO: 1 includes only exons, as compared to the natural sequence containing both exons and introns). The claimed DNA has no different functional characteristics, i.e., it encodes the same protein as the natural gene. Here, the differences in structural characteristics between the claimed DNA and the natural gene are significant, e.g., they are enough to ensure that the claim is not improperly tying up the future use of the BRCA1 gene. Thus, they rise to the level of a marked difference, and the claimed DNA is not a ‘‘product of nature’’ exception. Thus, the claim is not directed to an exception (Step 2A: NO). The claim is eligible.

Example 3. Diamond v. Diehr (U.S. Patent No. 4,344,142)

Background:

The claimed invention ia process for molding raw, uncured synthetic rubber into cured precision products. The process uses a mold for precisely shaping the uncured material under heat and pressure and then curing the synthetic rubber in the mold so that the product will retain its shape and be functionally operative after the molding is completed. Achieving the perfect cure depends upon several factors including the thickness of the article to be molded, the temperature of the molding process, and the amount of time that the article is allowed to remain in the press. It is possible to calculate when to open the press and remove the cured product using well-known time, temperature, and cure relationships by means of the Arrhenius equation. The inventors characterize their invention as the process of constantly measuring the actual temperature inside the mold, and automatically feeding these temperature measurements into a computer that repeatedly recalculates the cure time by use of the Arrhenius equation. When the recalculated time equals the actual time that has elapsed since the press was closed, the computer signals a device to open the press.

Representative Claim:

Claim 1. A method of operating a rubber molding press for precision molded compounds with the aid of a digital computer, comprising:

providing said computer with a data base for said press including at least, natural logarithm conversion data (ln), the activation energy constant (C) unique to each batch of said compound being molded, and a constant (x) dependent upon the geometry of the particular mold of the press, initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure, constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding, constantly providing the computer with the temperature (Z), repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure, which is ln v = CZ+x, where v is the total required cure time, repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and opening the press automatically when a said comparison indicates equivalence.

Analysis:

The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim recites the Arrhenius equation, which is the mathematical formula: ln v = CZ+x. The court noted that an algorithm, or mathematical formula, is like a law of nature, which cannot be the subject of a patent. The claimed process when viewed as a whole focuses on the use of the Arrhenius equation to cure synthetic rubber. Thus, the claim is directed to an exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The specifically disclosed and claimed constant measurement of temperature at a mold cavity of a rubber-molding press and the claimed repetitive computer recalculation of the appropriate cure time using the constantly updated measurements are additional elements that provide ‘‘something more’’ than mere computer implementation of calculation of the Arrhenius equation. Further, the claimed steps act in concert to transform raw, uncured rubber to cured molded rubber. The combination of steps recited in addition to the mathematical formula show that the claim is not to the formula in isolation, but rather that the steps impose meaningful limits that apply the formula to improve an existing technological process. Thus, the claim amounts to significantly more than the judicial exception (Step 2B: YES). The claim is eligible.

Note: The Supreme Court has also characterized mathematical formulas as abstract ideas. As noted, all claims that are directed to a judicial exception, regardless of what the exception is called, are subject to the same analysis.

Example 4. Parker v. Flook

Background:

The invention is a method of updating alarm limits using a mathematical formula. An ‘‘alarm limit’’ is a number. During catalytic conversion processes, operating conditions such as temperature, pressure, and flow rates are constantly monitored. When any of these ‘‘process variables’’ exceeds a predetermined alarm limit, an alarm may signal the presence of an abnormal condition indicating either inefficiency or perhaps danger. The formula for updating alarm limits is used in a catalytic conversion processing system; however, there is no disclosure relating to that system, such as the chemical processes at work, the monitoring of process conditions, the determination of variables in the formula from process conditions, or the means of setting off an alarm or adjusting an alarm system.

Representative Claim:

Claim 1. A method for updating the value of at least one alarm limit on at least one process variable involved in a process comprising the catalytic chemical conversion of hydrocarbons wherein said alarm limit has a current value of Bo+K wherein Bo is the current alarm base and K is a predetermined alarm offset which comprises:

• (1) Determining the present value of said process variable, said present value being defined as PVL;
• (2) Determining a new alarm base B1, using the following equation: B1=Bo(1.0–F) + PVL(F) where F is a predetermined number greater than zero and less than 1.0;
• (3) Determining an updated alarm limit which is defined as B1+GK; and thereafter;
• (4) Adjusting said alarm limit to said updated alarm limit value.

Analysis:

The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim recites the mathematical formula ‘‘B1=Bo(1.0–F) + PVL(F)’’. The claimed invention focuses on the calculation of the number representing the alarm limit value using the mathematical formula. Thus, the claim is directed to a mathematical formula, which is like a law of nature that falls within the exceptions to patent-eligible subject matter (Step 2A: YES).

A process is not unpatentable simply because it contains a law of nature or mathematical algorithm. The claim as a whole must be analyzed to determine what additional elements are recited in the claim. The claimed formula is limited by the steps of gathering the input variables and carrying out the calculation to update the number describing the alarm limit, and by the field of technology for which it is to be used. The determination of chemical process variables, and the use of a generic computer to calculate values, is routine and conventional in the field of chemical processing. Adjusting the alarm limit based on the solution to the mathematical formula is merely post solution activity that could be attached to almost any formula. Limiting the claim to petrochemical and oil-refining industries, such that the claim does not seek to wholly preempt the mathematical formula, is a field-of-use limitation that does not impose meaningful limits on the mathematical formula. Moreover, when considered as an ordered combination, the claim is nothing more than a purely conventional computerized implementation of applicant’s formula. Therefore, the claim as a whole does not provide significantly more than a generic computer upon which the claimed formula is calculated. Thus, the claim does not amount to significantly more than the judicial exception itself (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101.

Example 5. Mayo v. Prometheus (U.S. Patent No. 6,355,623)

Background:

The invention is a method of assisting doctors who use thiopurine drugs to treat patients with autoimmune diseases. The method helps doctors determine whether a given dosage level is too low or too high, based on the relationship between the concentration in the blood of a thiopurine metabolite (6-thioguanine) and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. The relationship is a natural consequence of the ways in which thiopurine compounds are metabolized by the body, even though human action is needed to trigger a manifestation of the relationship.

Representative Claim:

Claim 1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6- thioguanine to a subject having said immune mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6- thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Analysis:

The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim sets forth relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The claim recites that relation and, thus, is directed towards a natural law (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The ‘‘administering’’ step simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs. That audience is a pre-existing audience; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims. The ‘‘wherein’’ clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that the doctor should take those laws into account when treating the patient. The ‘‘determining’’ step tells the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use. The claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. Even though the laws of nature at issue are narrow laws that may have limited applications, the claim does not amount to significantly more than the natural law itself (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101.

Example 6. Alice Corp. v. CLS Bank (U.S. Patent Nos. 5,970,479 and 7,725,375)

Background:

The claims at issue relate to a computerized scheme for mitigating ‘‘settlement risk’’; i.e., the risk that only one party to an agreed upon financial exchange will satisfy its obligation. In particular, the claims are designed to facilitate the exchange of financial obligations between two parties by using a computer system as a third-party intermediary. The intermediary creates ‘‘shadow’’ credit and debit records (i.e., account ledgers) that mirror the balances in the parties’ real-world accounts at ‘‘exchange institutions’’ (e.g., banks). The intermediary updates the shadow records in real time as transactions are entered, allowing only those transactions for which the parties’ updated shadow records indicate sufficient resources to satisfy their mutual obligations. At the end of the day, the intermediary instructs the relevant financial institutions to carry out the ‘‘permitted’’ transactions in accordance with the updated shadow records, thus mitigating the risk that only one party will perform the agreed upon exchange. The invention is claimed in the form of a computer implemented process, a system enabling that process, and a computer-readable medium enabling that process to be performed by a computer.

Representative Method Claim (U.S. Patent No. 5,970,479)

Claim 33. A method of exchanging obligations as between parties, each party holding a credit record and a debit record with an exchange institution, the credit records and debit records for exchange of predetermined obligations, the method comprising the steps of:

(a) creating a shadow credit record and a shadow debit record for each stakeholder party to be held independently by a supervisory institution from the exchange institutions;
(b) obtaining from each exchange institution a start-of-day balance for each shadow credit record and shadow debit record;
(c) for every transaction resulting in an exchange obligation, the supervisory institution adjusting each respective party’s shadow credit record or shadow debit record, allowing only these transactions that do not result in the value of the shadow debit record being less than the value of the shadow credit record at any time, each said adjustment taking place in chronological order; and
(d) at the end-of-day, the supervisory institution instructing one of the exchange institutions to exchange credits or debits to the credit record and debit record of the respective parties in accordance with the adjustments of the said permitted transactions, the credits and debits being irrevocable, time invariant obligations placed on the exchange institutions.

Analysis:

The claim is directed to a statutory category, i.e., a process (Step 1: YES). The claim recites the concept of managing settlement risk through an intermediary, i.e., intermediated settlement. The claimed invention describes the procedures an intermediary should take in managing settlement risk between two parties, i.e., specific details of intermediating settlement. Intermediated settlement, like risk hedging in Bilski, is not a preexisting fundamental truth but rather is a longstanding commercial practice (a method of organizing human activity). The concept of intermediated settlement is a fundamental economic practice long prevalent in our system of commerce, which is in the realm of abstract ideas identified by the Supreme Court. Thus, the claim is directed to the abstract idea of intermediated settlement (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Although a computer acts as the intermediary in the claimed method, the claims do no more than implement the abstract idea of intermediated settlement on a generic computer. Using a computer to create and maintain ‘‘shadow’’ accounts amounts to electronic recordkeeping, which is one of the most basic functions of a computer. The same is true with respect to the use of a computer to obtain data, adjust account balances, and issue automated instructions. All of these computer functions are ‘‘well understood, routine, conventional activit[ies]’’ previously known to the industry. Each step does no more than require a generic computer to perform generic computer functions. Considered as an ordered combination, the computer components of the method add nothing that is not already present when the steps are considered separately, and thus simply recite the concept of intermediated settlement as performed by a generic computer. The claims do not purport to improve the functioning of the computer itself, or to improve any other technology or technical field. Use of an unspecified, generic computer does not transform an abstract idea into a patent-eligible invention. Thus, the claim does not amount to significantly more than the abstract idea itself (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101.

Representative System Claim (U.S. Patent No. 7,725,375)

Claim 26. A data processing system to enable the exchange of an obligation between parties, the system comprising: a communications controller, a first party device, coupled to said communications controller, a data storage unit having stored therein

(a) information about a first account for a first party, independent from a second account maintained by a first exchange institution, and
(b) information about a third account for a second party, independent from a fourth account maintained by a second exchange institution; and a computer, coupled to said data storage unit and said communications controller, that is configured to

(a) receive a transaction from said first party device via said communications controller;
(b) electronically adjust said first account and said third account in order to effect an exchange obligation arising from said transaction between said first party and said second party after ensuring that said first party and/or said second party have adequate value in said first account and/or said third account, respectively; and
(c) generate an instruction to said first exchange institution and/or said second exchange institution to adjust said second account and/or said fourth account in accordance with the adjustment of said first
account and/or third account, wherein said instruction being an irrevocable, time invariant obligation placed on said first exchange institution and/or said second exchange institution.

Analysis:

The claim is directed to a statutory category, i.e., a machine (Step 1: YES). As discussed for the method claim, the claim recites the concept of intermediated settlement and is directed to an abstract idea (Step 2A: YES).

Looking again to see what additional features are recited in the claim, the system includes a communications controller, a first party device, a data storage device, and a computer. The claimed hardware is generic hardware that nearly every computer will include. None of the hardware offers a meaningful limitation beyond generally linking the system to a particular technological environment, that is, implementation via computers. Put another way, the system claims are no different from the method claims in substance; the method claims recite the abstract idea implemented on a generic computer, while the system claims recite a handful of generic computer components configured to implement the same idea. The claim does not amount to significantly more than the underlying abstract idea (Step 2B: NO). The claim is not eligible and should be rejected under 35 U.S.C. 101.