1. Post-Prometheus Interim Examination Guidelines Daphne Lainson Smart & Biggar AIPLA 1

2. Mayo v. Prometheus 566 U.S. _ (2012) On March 20, 2012, Supreme Court releases its decision finding Prometheus’ patents claiming diagnostic methods invalid under 35 U.S.C. § 101  US 6,355,623 and US 6,680,302 claim patent-ineligible laws of nature  35 U.S.C. § 101 — 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. 2

3. Representative Claim (‘623 Patent) 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 8×10 8 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 8×10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. 3

4. Supreme Court Decision “administering a drug providing…”  “…the ‘administering’ step simply refers to the relevant audience...[t]hat audience is a pre-existing audience; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims...  “…the ‘prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’’”  Machine-or-transformation test a useful clue to eligibility, but the administering step is an “irrelevant” transformation: “…As we have pointed out, the ‘administering’ step simply helps to pick out the group of individuals who are likely interested in applying the law of nature...” 4

5. Supreme Court Decision “determining the level of…”  “…this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field. Purely ‘conventional or obvious’ ‘[pre]-solution activity’ is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”  Step could be performed without transformation: “…the second step could be satisfied without transforming the blood, should science develop a totally different system for determining metabolite levels that did not involve such a transformation…” “wherein…”  “…the ‘wherein’ clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient.” 5

6. Supreme Court Decision Claim as a whole does not relate to patent-eligible subject matter  “…to consider the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately.” 6

7. Prometheus: Policy Considerations? Claims inhibit further discovery:  “The Court has repeatedly emphasized… a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.”  “The laws of nature at issue here are narrow laws…but…they tie up the doctor’s subsequent treatment decision…And they threaten to inhibit the development of more refined treatment recommendations…The ‘determining’ step too is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.” 7

8. Prometheus: What is patentable? Prometheus patent “[u]nlike…a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws…” Claims in Diamond v. Diehr, 450 US 175 (1981) acceptable  Patent claimed a method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer using the Arrhenius equation in the process  Claim included additional steps that integrated the equation into the process as a whole, and did not preclude others from using the principle in different applications 8

9. Interim Examination Guidelines USPTO issues a memorandum to the Patent Examining Corps on March 21, 2012 relating to Prometheus Interim Examination Guidelines released to Corps on July 3, 2012 superseding March 21 memorandum Guidance an interim step until pending cases at Federal Circuit reheard in view of Prometheus (Myriad, Ultramercial)  Comprehensive updated guidance to follow resolution of these cases 9

10. Interim Examination Guidelines Compact prosecution  Office personnel to state all non-cumulative reasons and bases for rejecting a claim in a first Office Action, and should not focus solely on § 101 “except in the most extreme cases” Guidance applies only to applications relating to process claims involving laws of nature  2010 Interim Bilski Guidance applies to process claims that do not include a law of nature, a natural phenomenon, or naturally occurring relations or correlations as a claim limitation  Bilski Guidance applies to claims relating to “abstract ideas” 10

11. Stepwise analysis A. Determine what applicant invented  Review the entire specification and claims to determine what applicant invented B. Establish broadest reasonable interpretation of claim as a whole  Establish the broadest reasonable interpretation of the claims when read in light of the specification and from the view of one of ordinary skill in the art  Identify and evaluate each claim limitation and then consider the claim as a whole  Improper to dissect claims into discrete elements and then evaluate the elements in isolation  Same interpretation must be used to evaluate the compliance with each statutory requirement 11

12. Stepwise Analysis C. Conduct the following three inquiries to claim as a whole: 1. Is the claimed invention directed to a process, defined as an act, or a series of acts or steps? 2. Does the claim focus on use of a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?) 3. Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature + the general instruction to simply “apply it”?) 12

13. Question 1. 1. Is the claimed invention directed to a process, defined as an act, or a series of acts or steps?  Claim must be drawn to a process/method  A process is defined as an act, or a series of acts or steps  For product claims, apply Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101 issued August 24, 2009 If answer to this question is “yes”, then proceed to Question 2 13

14. Question 2. 2. Does the claim focus on use of a law of nature…Is the natural principle a limiting feature of the claim?  Natural principle = the handiwork of nature, occurs without the hand of man  Examples of natural principles:  disinfecting property of sunlight  relationship between blood glucose levels and diabetes  a correlation that occurs naturally when a man-made product (e.g., a drug) interacts with a naturally occurring substance (e.g., blood)  a claim that recites a correlation used to make a diagnosis If natural principle is a limiting element or step, then continue to Question 3  If the claim focuses on an abstract idea: Bilski Guidance 14

15. Question 3. 3. Does the claim include additional elements/steps…Is it more than a law of nature + the general instruction to simply “apply it”?)  Claim must include additional elements/steps to show that the inventor has practically applied, or added something significant to, the natural principle itself  Not every recited element/step in the process needs to meet requirements (one element/step is enough) 15

16. Question 3: Additional elements/steps  Must impose a meaningful limit on the scope of claim  Be significantly more than a description of the natural principle itself; be more than insignificant extra-solution activity; do more than provide instructions to apply the natural principle  Must not foreclose others from using the natural principle for future innovation  Cannot cover every substantial practical application of the natural principle  Must be more than well-understood, purely conventional, and routine steps taken by others to apply the natural principle,  Must do more than limit the use to a particular technological environment (field-of-use) 16

17. Question 3: Additional elements/steps  Insufficient limitations:  Method for diagnosing an infection: correlating the presence of a certain bacterium in a person’s blood with a particular type of bacterial infection, recording the diagnosis on a chart  Recording = extra-solution activity unrelated to the correlation, does not integrate the correlation into the invention  Step of taking a sample, which is recited at a high level of generality to test for a naturally occurring correlation 17

18. Question 3: Additional elements/steps  Sufficient:  A claim for a new drug and associated method claims or a new way of using an existing drug  A claim for a new drug or a new use of an existing drug, in combination with a natural principle  Claim amounts to significantly more than the natural principle 18

19. Relevant Factors for Question 3 Weighing factors from Bilksi are useful tools for evaluating a claim in Question 3  Satisfying Machine-or-Transformation test does not ensure eligibility if machine/transformation does not integrate natural principle to show the natural principle is practically applied, and if claim not significantly more than natural principle itself 19

20. No practical application? Conventional steps claimed at a high level of generality Well-understood, routine, conventional steps that add nothing specific Application of the principle using any machinery or without apparatus Claiming substantially every practical application of the principle in a field Limitations that are necessary for all practical applications of the principle Nominally, insignificantly, or tangentially related (e.g., data gathering or data storage) or incidental (e.g., a computer as a counterbalance weight and not as a processing device) machines or transformations Complete absence of a machine or transformation Mere statement of the natural principle 20

21. Practical application? A claim that does not cover every substantial practical application of a natural principle Describing details of how a machine and its specific parts implement the natural principle or how the transformation relates to or implements the natural principle Elements/steps that are recited with specificity such that all substantial applications are not covered (e.g., observable and verifiable steps, rather than subjective or imperceptible steps) See claim in Diamond v. Diehr 21

22. Objections/Responses Examiners are to:  Identify the natural principle  Identify that the claim is effectively directed to a natural principle itself  Explain the reason(s) for conclusion (applying inquiries 1-3) Proper responses:  Argument: e.g., “steps are not routine, well-known or conventional”  Amendments to add steps/features or amend existing steps features Guidance provides examples of patent eligible and patent ineligible claims with analysis 22

23. Prosecution Considerations Guidelines are only interim, further guidance to come Factors and examples in Guidelines provide a road map for argument/amendment  Clues also found in Prometheus decision 23