Recent Developments Concerning Patent-Eligible Subject Matter Yale University September 11, 2014

1. Recent Developments Concerning Patent-Eligible Subject MatterYale UniversitySeptember 11, 2014 Down the Rabbit Hole….. Wolf, Greenfield & Sacks, P.C. |600 Atlantic Avenue |Boston, Massachusetts 02210 |617.646.8000 | 617.646.8646 fax |wolfgreenfield.com

2. Supreme Court IP Cases • Mayo v. Prometheus • Aereo • Alice • Nautilus • Limelight • Octane • Pom Wonderful

4. Economics • Industries that directly rely on patents and trademarks support about 40 million jobs - about 25% of all jobs in the U.S. • These industries account for approximately $5 trillion – about 35% of the U.S. GDP • AUTM Licensing Activity Survey 2013 University and Non-Profit Patent Licensing Impact 1996-2010 as much as: $388 billion on U.S. gross domestic product $836 billion on U.S. gross industrial output* *Biotechnology Industry Organization

5. 35 U.S. Code § 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.

6. Judicially Created Exceptions • Laws of Nature/Scientific Discoveries • Applied Force equals the mass of an object multiplied by its acceleration • Energy content of an object equals its mass multiplied by the square of the speed of light • Levels of drug metabolites in human body

7. Judicially Created Exceptions (Con’t.) • Abstract Ideas/Formulas • Mathematical Equations - • Preexisting, Fundamental Truths - Pythagorean Theorem • Natural Phenomena • Lightning • Gravity

8. Question Presented • Whether claims to computer-implemented inventions—including claims to systems and machines, processes, and items of manufacture—are directed to patent-eligible subject matter within the meaning of 35 U.S.C. § 101 as interpreted by this Court. • Focus on computer-implemented scheme but decision applies across technologies.

9. Alice v. CLS – “Technology” • Computer-implemented scheme for mitigating settlement risk. • Third party intermediary maintains “shadow credit record” and “shadow debit record” for each transacting party. • For each proposed transaction, third party checks if any party would end up owing more than being owed. Assets Liabilities

10. Technology in Prometheus Patent • Use of thiopurine drugs to treat an immune-mediated GI disorder claim: • A method of optimizing therapeutic efficacy for treatment of an immune-mediated GI disorder, comprising: a) administering a drug providing 6-thioguanine to a subject. . . ., and b) determining the level of 6-thioguanine in said subject . . . ., wherein the level of 6-thioguanine less than about 230 pmol 8x108RBCs indicates a need to increase . . . and wherein the level of 6-thioguanine greater than about 400 pmol 8x108 RBCs indicates a need to decrease . . . .

11. Issue before U.S. Supreme Court • Do the claims do significantly more than simply describe the natural relations in which thiopurine compounds are metabolized by the body? • Conclusion: “steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities” • A patent cannot “simply recite a law of nature and then add the instruction apply the law.”

12. Supreme Court Two-Part Test to Determine Subject-Matter Eligibility • Mayo Framework applies to all judicial exceptions. • Is invention directed to law of nature, natural phenomena, or abstract idea? • If so, search for an “inventive concept” that ensures the claim amounts to “significantly more” than the law of nature, natural phenomena, or abstract idea itself. • Mayo Framework applies to all claim types.

13. Step One • Is the invention Directed to a Judicial Exception? • Law of Nature • Natural Phenomenon • Abstract Ideas • Claims are Directed to the Concept of “Intermediated Settlement”

14. Step One (Con’t.) • Intermediated Settlement is a Fundamental Economic Concept • “long prevalent in our system of commerce” • “building blocks of the modern economy” • “taught in any introductory finance class” • “long standing economic practice” • Fundamental Economic Concepts can be Abstract Ideas • So, YES!

15. Step Two • Is there “inventive concept” that amounts to “significantly more” than the judicial exception? • More than mere conventional activity • Can be either a new element or a combination of old elements • Insufficient • Generic computer Implementation (Alice) • Well-understood, routine, conventional activities • Limiting use to particular technological environment

16. Step Two (Con’t.) • Possibly Sufficient • Improving existing technological process • Improving another technology or technical field • Improving the functioning of computer itself

17. What Alice v. CLS Tells Us • The abstract idea exception is broader than mathematical formulas and preexisting, fundamental truths • No categorical exclusion of business methods. • Concurrence: Sotomeyor, Ginsburg, Breyer would have created business method exception.

18. What is an Abstract Idea? Abstract Idea Mathematical Algorithms/Formulas Preexisting, Fundamental Truths Methods of Organizing Human Activities Fundamental Economic Practice

19. What Alice v. CLS Does Not Tells Us: • “In any event, we need not labor to delimit the precise contours of the ‘abstract idea’ category in this case.” • What standards of novelty and non-obviousness for 101 purposes? • Same as 102 and 103? • Since the abstract idea is considered known, is this like a 103 rejection without a reference?

20. USSN: 13/193,421, allowed 12/2013 • 1. A method of diagnosing, aiding in diagnosing or predicting risk of developing early onset neonatal sepsis (EONS) in a newborn subject, comprising: (a) determining if switching of an Hp 0-0 phenotype to an Hp 1-1, an Hp 2-2 or an Hp 1-2 phenotype has occurred in the newborn subject; • and (b) diagnosing or aiding in diagnosing the newborn subject as having EONS, or predicting that the newborn subject is at increased risk of developing EONS, if switching of an Hp 0-0 phenotype to an Hp 1-1, an Hp 2-2 or Hp 1-2 phenotype has occurred. • Canceled: • 36. (New) A method of diagnosing, aiding in diagnosing or predicting risk of developing early onset neonatal sepsis (EONS) in a newborn subject, comprising:

21. USSN: 13/193,421, allowed 12/2013 (cont’d) • (a) detecting haptoglobulin and haptoglobulin-related protein (Hp&HpRP) immunoreactivity in a biological sample of the newborn subject; and • (b) diagnosing or aiding in diagnosing the newborn subject as having EONS, or predicting that the newborn subject is at increased risk of developing EONS, if Hp&HpRP immunoreactivity is detected in the biological sample.

22. USSN: 13/131,787, recently allowed • An agent comprising • a first peptide comprising the amino acid sequence of SEQ ID NO: 13, • a second peptide comprising the amino acid sequence of SEQ ID NO: 14, and • a third peptide comprising the amino acid sequence of SEQ ID NO: 16.