1. 1 TC 1600 Subject Matter Eligibility Under 35 USC § 101 Andrew Wang SPE 1631 (571) 272-0811

2. 2 Introduction of Interim Guidelines Posted on USPTO web site 10/26/2005 Published in the Official Gazette 11/22/2005 http://www.uspto.gov/web/offices/com/sol/og/2005/week47/patgupa.htm

3. 3 Application of Guidelines Any position taken on 35 USC § 101 is based on the substantive law, not the guidelines themselves The interim guidelines do not constitute substantive rulemaking and do not have the effect of law The interim guidelines set forth the procedures USPTO personnel will follow when examining applications

4. 4 Prerequisite to Analysis Under 35 USC § 101 Determine what applicant invented Review the specification and claims Conduct a thorough search of the art Identify and understand: –any utility and/or practical application asserted by applicant –the meaning of claim terms –claim scope

5. 5 Improper Tests for Subject Matter Eligibility Tests that are not to be applied “not in the technological arts” test Freeman-Walter-Abele test Mental step or human step tests The machine implemented test The per se data transformation test

6. 6 Analysis Under 35 USC § 101 1)Does the claimed invention fall within one of the four statutory categories?

7. 7 1) Statutory Categories 35 USC § 101 reads: “whoever invents or discovers any new and useful process, machine, manufacture, or composition, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”

8. 8 Enumerated Categories A “machine’, “manufacture”, and “composition of matter” all define things and products. A “process” defines actions (i.e. inventions) that set forth a series of steps or acts to be performed.

9. 9 Examples Outside of the Statutory Categories 1)Literary Works per se 2)Rules to play a game per se 3)Legal agreements, e.g. an insurance policy 4)Signals per se 5)A computer program, logic, or language per se

10. 10 If Not, Do Not Stop If a claim does not fall into a statutory category, that does not preclude complete examination for all other conditions of patentability The examiner must continue with the analysis under 35 USC § 101 and still examine the claims for compliance with 102, 103, and 112.

11. 11 Analysis Under 35 USC § 101 1)Does the claimed invention fall within one of the four statutory categories? 2) Does the claimed invention fall within a judicial exception?

12. 12 2) Judicial Exceptions The Supreme Court has specifically identified three categories of non-statutory subject matter –Laws of Nature per se –Natural Phenomena per se –Abstract Ideas per se

13. 13 Examples of Judicial Exceptions Laws of nature E=mc 2 ; F=ma; V=IR Natural Phenomena The heat of the sun; electricity; a new mineral Abstract Ideas Mathematical algorithms; legal rights

14. 14 If Yes, Do Not Stop While judicial exceptions per se are not patent eligible, methods and products employing abstract ideas, natural phenomena, and laws of nature to perform a real-world function may well be The scope of a claim must be ascertained to determine if it covers a Sec. 101 judicial exception or practical application of a Sec. 101 judicial exception

15. 15 Analysis Under 35 USC § 101 1)Does the claimed invention fall within one of the four statutory categories? 2) Does the claimed invention fall within a judicial exception? 3) Does the claimed invention provide a practical application?

16. 16 3) Practical Applications resultIf the claim is directed to a practical application of the Sec. 101 judicial exception producing a result tied to the physical world that does not preempt the judicial exception, then the claim meets the statutory requirement

17. 17 Physical Transformation Does the claimed invention transform an article or physical object to a different state? Transformation of data is not considered a physical transformation Physical acts are not necessarily a physical transformation

18. 18 Determination of a Useful, Concrete, and Tangible Result resultIf the examiner does not find such a physical transformation, the examiner must determine whether the claim provides a practical application that produces a useful, concrete, and tangible result A useful concrete, and tangible result must either be specifically recited in the claim or inherently flow therefrom A practical application is provided when a judicial exception is applied, as claimed, to produce a useful, concrete, and tangible result

19. 19 Useful Result The claimed invention as a whole must satisfy the utility requirement of 35 USC § 101: specific, substantial, and credible These criteria require an evaluation of the specification and the knowledge of one of ordinary skill in the art

20. 20 Concrete Result Generally, a claimed invention is not concrete when a result cannot be assured or is not reproducible Concrete is not a requirement that the result must be 100% accurate (e.g.: a claim directed to a method of estimating, predicting, or approximating)

21. 21 Tangible Result A tangible result is a real world result The opposite meaning of “tangible” is “abstract” (e.g.: thoughts and ideas are not real world results) notThe tangible result requirement does not necessarily mean that a claim must be tied to a particular machine or apparatus or must operate to change articles or materials to a different state (i.e. it is not a duplicate of physical transformation)

22. 22 Computer Related Products Computer-related products such as software, data structures, and collections of data are also evaluated for a practical application Computer-related products are classified in one of two groups: –Functional Descriptive Material –Non-Functional Descriptive Material

23. 23 Functional Descriptive Material computer component“Functional Descriptive Material” includes data structures and computer programs which impart functionality when employed as a computer component The definition of “data structure” is “a physical or logical relationship among data elements, designed to support specific data manipulation functions.” [ see The New IEEE Standard Dictionary of Electrical and Electronics Terms 308 (5 th ed. 1993)]

24. 24 Functional Descriptive Material Functional descriptive Material per se is not statutory Functional Descriptive Material in combination with an appropriate computer readable medium must be capable of producing a useful, concrete, and tangible result when used in conjunction with a computer system –the “computer readable medium” must be a physical structure, not a signal, which permits the functionality to be realized with the computer

25. 25 Non-Functional Descriptive Material Non-Functional Descriptive Material per se is an abstract idea and therefore non-statutory Non-Functional Descriptive Material is not statutory even in combination with a computer or physical medium (e.g.: experimental data stored in computer memory) –no useful, concrete, or tangible result is produced –no functionality is imparted to a computer (i.e. it is not a computer component)

26. 26 Examples of Non-Functional Descriptive Material Music Literature Art Photographs Data formats, frames, or packets A data base per se Mere arrangements of facts or compilations of data Share price on a disk Even when non-functional descriptive material is stored on, read by, or outputted to a computer without any physical interrelationship, they do not impart functionality to the computer

27. 27 Analysis Under 35 USC § 101 1)Does the claimed invention fall within one of the four statutory categories? 2) Does the claimed invention fall within a judicial exception? 3) Does the claimed invention provide a practical application? 4) Does the claimed invention preempt a judicial exception?

28. 28 4) Preemption A claim may not preempt every “substantial practical application” of an abstract idea, law of nature, or natural phenomena because it would in practical effect be a patent on the judicial exceptions themselves In order to establish a case of preemption, the examiner must identify the abstraction, law of nature, or natural phenomenon and explain why the claim covers every practical application thereof

29. 29 Example 1 Claim 1 (original). A computer program comprising: (i) first instructions for causing a computer executing said instructions to read gene expression data from memory; (ii) second instructions for causing said computer to analyze said gene expression data and identify genes with catalytic enzymatic activity; and (iii) third instructions for causing said computer to transmit said identified genes with catalytic enzymatic activity to a user.

30. 30 Example 1 (cont.) Claim 1 (currently amended). A computer memory comprising a program, wherein said program further comprises[[ing]]: (i) first instructions for causing a computer executing said instructions to read gene expression data from memory; (ii) second instructions for causing said computer to analyze said gene expression data and identify genes with catalytic enzymatic activity; and (iii) third instructions for causing said computer to transmit said identified genes with catalytic enzymatic activity to a user.

31. 31 Example 1 (cont.) Claim 1 (currently amended). A computer memory comprising executable code for a program, wherein said program further comprises: (i) first instructions for causing a computer executing said instructions to read gene expression data from memory; (ii) second instructions for causing said computer to analyze said gene expression data and identify genes with catalytic enzymatic activity; and (iii) third instructions for causing said computer to transmit said identified genes with catalytic enzymatic activity to a user.

32. 32 Example 1 (cont.) Claim 1 (currently amended). A computer memory comprising executable code for a program, wherein said program further comprises: (i) first instructions for causing a computer executing said instructions to read gene expression data from memory; (ii) second instructions for causing said computer to analyze said gene expression data and identify genes with catalytic enzymatic activity; and (iii) third instructions for causing said computer to transmit said identified genes with catalytic enzymatic activity to a user and further displaying said identified genes on a computer screen.

33. 33 Example 2 Disclosure: The purpose of the invention is to provide a method for inserting a medical instrument at an optimal location in a human body for the purpose of deploying the instrument during a surgical procedure using the instrument. Claim 1 (original). A method of determining an optimal location for insertion of a medical instrument into a human body comprising: i) determining a treatment site within a human body; ii) selecting an instrument for use in treating the body at the treatment site; iii) determining the size and type of instrument; and iv) determining an optimal location for insertion of the instrument using an algorithm based on the size and type of the instrument and the treatment site.

34. 34 Example 2 (cont.) Claim 1 (currently amended). A method of determining an optimal location for insertion of a medical instrument into a human body comprising: i) determining a treatment site within a human body; ii) selecting an instrument for use in treating the body at the treatment site; iii) determining the size and type of instrument; [[and]] iv) determining an optimal location for insertion of the instrument using an algorithm based on the size and type of the instrument and the treatment site; and v) inserting the instrument at the determined optimal location.

35. 35 Example 3 Claim 1: The relationship between energy and mass as represented by the equation E=mc 2.

36. 36 Example 3 (cont.) Claim 1: A method of determining [[T]]the [[relationship between]] energy associated with the [[and]]mass [[as represented by]]of an object comprising: (i) determining the mass of said object; and (ii) determining the energy E of said object using the equation E=mc 2, wherein m is the determined mass of said object.

37. 37 Example 3 (cont.) Claim 1: A method of determining the energy associated with the mass of [[an object]]a spaceship comprising: (i) determining the mass of said spaceship[[object]]; and (ii) determining the energy, E, of said spaceship[[object]] using the equation E=mc 2, wherein m is the determined mass of said spaceship[[object]].

38. 38 Example 3 (cont.) Claim 1: A method of determining the energy associated with the mass of a spaceship comprising: (i) determining the mass of said spaceship; [[and]] (ii) determining the energy, E, of said spaceship using the equation E=mc 2, wherein m is the determined mass of said spaceship; and (iii) displaying the determined energy to a passenger on said spaceship.

39. 39 Acknowledgement Special thanks is extended to Eric DeJong for his contributions to the preparation of this presentation.