1. INTERIM GUIDELINES FOR PATENT SUBJECT MATTER ELIGIBILITY ARDIN MARSCHEL SPE AU 1631 (571) 272-0718 ardin.marschel@uspto.gov

2. 2 Interim Guidelines Guidelines being developed for the purpose of: n n Assisting examiners in determining whether a claim is directed to statutory subject matter under 35 U.S.C. § 101.

3. 3 Interim Guidelines n n Posted at www.uspto.gov [under Patents,;Guidance; Tools & Manuals; Notices: Recent Patent- Related] on October 26, 2005www.uspto.gov n n Published in 1300 OG 142 on November 22, 2005:

4. 4 Interim Guidelines Intro n n What’s In:   Statutory Categories   Judicial Exceptions   Practical Application   Preemption

5. 5 Interim Guidelines Intro n n What’s Out:   “Not in the Technological Arts”   Freeman-Walter-Abele   Mental Steps or Human Steps   Machine Implemented   Data Transformation

6. 6 Prerequisites to Analysis Under 101 n n Determine what applicant invented.   Review the spec and claims.   Identify and understand:   Any utility and/or practical application asserted by applicant;   The meaning of claim terms; and   Claim scope n n Conduct a thorough search.   What is known in the art can contribute to understanding the invention.

7. 7 Analysis Under 101 1) 1) Does the claimed invention fall within one of the four statutory categories? 2) 2) Does the claimed invention fall within a judicial exception? 3) 3) Does the claimed invention provide a practical application? 4) 4) Does the claimed invention preempt a judicial exception?

8. 8 Statutory Categories n n For what do we grant patents?   35 U.S.C. §101 reads: “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 therefore, subject to the conditions and requirements of this title.”

9. 9 Statutory Categories n n A “machine”, “manufacture”, and “composition of matter” all define things or products n n A “process” defines actions i.e. inventions that set forth a series of steps or acts to performed

10. 10 Examples Not in One of the Statutory Categories 1. 1. Literary works per se. 2. 2. Rules to play a game per se. 3. 3. Legal documents per se, e.g. an insurance policy. 4. 4. Signals per se. 5. 5. A computer language per se.

11. 11 If Not, Don’t Stop If the examiner can establish that 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 101 analysis and must still examine the claims for compliance with 102, 103 and 112.

12. 12 Judicial Exceptions n n Despite the apparent sweep of 35 U.S.C. §101, the Supreme Court has specifically identified three categories of nonstatutory subject matter:   Laws of nature, per se   Natural phenomena, per se   Abstract ideas, per se

13. 13 Judicial Exception Examples   Laws of nature   e=mc 2 ; f=ma   Natural phenomena   the heat of the sun; electricity; a new mineral   Abstract ideas   mathematical algorithms; legal rights

14. 14 If Yes, Don’t Stop   If a judicial exception is found in the claim, further analysis under 101 is required.

15. 15 Practical Application n n Two ways to provide a practical application:   Physical Transformation, OR   Produce A Useful, Concrete, and Tangible Result

16. 16 Physical Transformation n n The claimed invention transforms an article or physical object to a different state or thing n n If transformation is found, this ends the analysis for statutory subject matter n n Transformation of data is not “physical transformation” n n Example: manufacturing a tire by curing rubber

17. 17 Useful, Concrete, Tangible n n If no physical transformation appears in the claim, check for a “useful, concrete and tangible result” n n The focus is on the result, not the steps or structure used to produce the result n n A useful, concrete and tangible result must be either specifically recited in the claim or flow inherently therefrom

18. 18 “Useful” n n The claimed invention as a whole must satisfy the utility requirement of 101:   specific,   substantial, and   credible utility n n These criteria require evaluation of the specification and the knowledge in the art.

19. 19 “Useful” n n A complete disclosure should contain some indication of why the claimed invention is useful n n If the claimed invention does not fulfill any of the disclosed utilities, determine if the utility would have been recognized by those in the art

20. 20 “Concrete” n n Usually, a claimed invention is not concrete when a result cannot be assured or is not reproducible n n Concrete is not a requirement that the result must be 100% accurate (e.g., a claim directed to estimating, predicting or approximating something does not necessarily lack concreteness) n n May require a determination of the level of ordinary skill in the art

21. 21 “Tangible” n n “Real world” result n n Not necessarily tied to a machine; not a duplicate of “physical transformation” n n In other words, the opposite of “tangible” is “abstract” n n Example: Calculating a price of an item to sell and then conveying the calculated price to a potential customer n n Thoughts are not “real world” results

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

23. 23 Functional Descriptive Material n n “Functional descriptive material" includes data structures and computer programs which impart functionality when employed as a computer component. n n 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 (5th ed. 1993).

24. 24 Functional Descriptive Material n n Functional Descriptive material per se is not statutory   Cf. In re Warmerdam, disembodied data structure claim. n n 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 a computer system   Cf. In re Warmerdam – data structure stored in a computer memory, and In re Lowry, 32 USPQ2d 1031 (Fed. Cir. 1994) – data structure in a “computer readable medium”.   The “computer readable medium” must be physical structure, not a signal, which permits the functionality to be realized with the computer.

25. 25 Non-Functional Descriptive Material n Non-functional descriptive material per se is an abstract idea, and therefore is not statutory n n Non-Functional Descriptive Material is not statutory even if in combination with a physical medium.   No useful, concrete or tangible result is produced.

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

27. 27 Practical Application n n A claim to a proper computer readable medium (not e.g. a signal) encoded with functional descriptive material that can function with a computer to effect a useful, concrete and tangible result (e.g. running an assembly line or executing a stock transaction) satisfies the practical application test

28. 28 Enablement n n In instances where the invention cannot be used as intended without undue experimentation, an appropriate rejection of the claim as being nonstatutory under 35 U.S.C. 101 should be accompanied by a lack of enablement rejection under 35 U.S.C. 112 first paragraph

29. 29 An Example n n Disclosure: The purpose of the invention is to provide a method for a 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.

30. 30 An Example Claim 1: A method of determining an optimal location for insertion of a medical instrument in a human body, comprising: determining a treatment site within a human body; selecting an instrument for use in treating the body at the treatment site; determining the size and type of the instrument; and determining an optimal location for insertion of the instrument using an algorithm based on the size and type of the instrument.

31. 31 An Example Analysis Claim 1 recites abstract ideas only with no practical application. Claim 1 does not result in a physical transformation or a useful, concrete and tangible result. Therefore, claim 1 is non-statutory

32. 32 Final Points n n Each claim should be reviewed for compliance with every statutory requirement for patentability in the initial examination on the merits n n All rejections under 35 U.S.C. 101, 102, 103 and 112 should be clearly communicated to applicant with the findings, conclusions, and reasons to support them

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