Michael P. Dunnam Presentation to Japan Patent Office April 7, 2014

1. CURRENT STATE OF 35 USC 101: “USPTO GUIDELINES ON PRODUCTS OF NATURE, LAWS OF NATURE, AND NATURAL PHENOMENA” Michael P. Dunnam Presentation to Japan Patent Office April 7, 2014

2. Mayo Decision In Mayo v. Prometheus (2012), the Supreme Court held that the basic tools of scientific and technological work are not patentable, even when claimed as a process, machine, manufacture, or composition of matter. Under Mayo, process claims having a natural principle as a limiting element or step should be evaluated by determining whether the claim includes additional elements or steps or a combination of elements or 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. The emphasis in Mayo was on practical application of the natural principle for patent eligibility and preemption of the natural principle for non-eligibility.

3. Myriad Decision • On June 13, 2013, Supreme Court held in connection with patent claims directed to BRCA1 and BRCA2 genes associated with breast and ovarian cancers that: • Extracted and isolated DNA from the human body is a “product of nature” and is an exception to statutory subject matter that is patent-eligible under 35 USC 101 • Complementary DNA (cDNA) is “not naturally occurring” and claims to such synthetic gene sequences are not subject to an exception to patent eligibility

4. Myriad Decision The Supreme Court did not address method claims (see Mayo) or the patentability of new applications of BRCA1 and BRCA2 genes or of DNA in which the order of naturally occurring nucleotides has been altered. Rather, the Supreme Court narrowly characterized its opinion as merely holding that genes and the information they encode are not patent eligible under 35 USC 101 simply because they have been isolated from the surrounding genetic material.

5. June 13, 2013 Memorandum to Examiners On June 13, 2013 (same day as Myriad decision), USPTO issued memorandum to examiners acknowledging that Myriad significantly changed the Office’s examination policy regarding nucleic acid-related technology. In its “preliminary guidance” to the examiners, the examiners were instructed to “reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 USC 101.” On the other hand, claims “clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally-occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible.” The USPTO indicated that it would later issue more comprehensive guidance on patent subject matter eligibility determinations.

6. March 4, 2014 Guidance Memorandum Guidelines are directed to all claims “reciting or involving laws of nature, natural principles, natural phenomena, or natural products.” The guidelines generally distinguish between claims reflecting a “significant difference” from what exists in nature (patent eligible) and claims drawn to something that is “naturally occurring” (patent ineligible). The “mere recitation of particular words (e.g., ‘isolated’) in the claims does not automatically confer eligibility.” Claims reciting an “abstract idea” are subject to the guidance for subject matter eligibility in MPEP 2106 (II), even where a natural product is recited. If claim recites an “abstract idea” and a law of nature, the claim is treated under MPEP 2106(II). New guidance memorandum supersedes 6/13/13 Memorandum.

7. Overall Process for Subject Matter Eligibility

8. March 4, 2014 Guidance Memorandum • The judicial exceptions to patentability include abstract ideas, laws of nature, natural principles, natural phenomena, and natural products, which includes scientific principles, disembodied concepts, mental processes, mathematical formulas, and the like. • Claimed subject matter subject to analysis includes but is not limited to: • Chemicals derived from natural sources (e.g., antibiotics, petroleum derivatives, etc.) • Foods (e.g., fruits, grains, meats and vegetables) • Metals and metallic compounds that exist in nature • Minerals • Natural materials (e.g., rocks, sands, soils) • Nucleic acids • Organisms (e.g., bacteria, plants and multicellular animals) • Proteins and peptides • Other substances found in or derived from nature

9. March 4, 2014 Guidance Memorandum • If any of the exceptions is implicated, further analysis for “significantly different” is required under the guidance as follows: • The claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or • The claim includes features or steps demonstrating that claimed subject matter is markedly different from what exists in nature. • The USPTO listed several factors to analyze the claim. The factors are weighed to establish patent eligibility or ineligibility. Weight accorded each factor “will vary based upon the facts of the application.” • Additional factors may be added over time. • The USPTO noted that the factor-based analysis is similar to the Wands factor-based analysis used to evaluate whether undue experimentation is required to made and use a particular claimed invention.

10. March 4, 2014 Guidance Memorandum Factors that weigh toward eligibility (significantly different): a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products. b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s). c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s).

11. March 4, 2014 Guidance Memorandum Factors that weigh toward eligibility (significantly different): d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s). e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application. (See MPEP 2106(II)(B)(1)). f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.

12. March 4, 2014 Guidance Memorandum Factors that weigh against eligibility (not significantly different): g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products. h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered. i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).

13. March 4, 2014 Guidance Memorandum Factors that weigh against eligibility (not significantly different): j) Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field. k) Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s). l) Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.

14. March 4, 2014 Guidance Memorandum USPTO noted that merely isolating a nucleic acid changes its structure by breaking bonds but does not create a marked difference in structure between the isolated nucleic acid and its naturally occurring counterpart. The difference must be “more than an incidental or trivial difference.” The fact that a “marked difference” resulted from routine activity or via human manipulation does not prevent the marked difference from weighing in favor of patent eligibility. For example, cDNA having a nucleotide sequence that is markedly different from naturally occurring DNA is eligible subject matter even though the process of making cDNA is routine in the biotechnology art.

15. Example A: Composition/Manufacture Claim Reciting Natural Product The hypothetical claims recite: A stable energy-generating plasmid, which provides a hydrocarbon degradation pathway. A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradation pathway. Guidance rejects first claim under Section 101 as not markedly different from what exists in nature as not reciting structural differences between the claimed plasmid and naturally occurring plasmids. Guidance approves second claim as significantly different than naturally occurring bacteria by reciting two energy-generating plasmids. Claim is both structurally different (genetic modification to include plasmids not found in naturally occurring Pseudomonas bacterium) and functionally different (degrades at least two different hydrocarbons as compared to naturally-occurring Pseudomonasbacterium that can only degrade a single hydrocarbon).

16. Example B: Composition v. Method Claims Each Reciting Natural Product The hypothetical claims recite: Purified amazonic acid. Purified 5-methyl amazonic acid. A method of treating colon cancer, comprising administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid. Claim 1 is not deemed patent-eligible as not structurally different from the compound as it exists in tree leaves. Claim 2 is deemed patent-eligible as structurally different from the compound as it exists in tree leaves, and the structural difference results in a functional difference. The Guidance notes that presence of the functional difference makes a stronger case for patent-eligibility. Claim 3 is deemed patent-eligible as factors b-d and f are satisfied. Particular dose and dosing schedule to particular patient limit the scope of claim. Also, prior usage of tree leaves containing the compound was not for the treatment of the recited colon cancer.

17. Example C: Composition v. Method Claims Each Reciting 2 Natural Products The hypothetical claims recite: A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2. A method of amplifying a target DNA sequence comprising: Providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine; Heating the reaction mixture … to separate the strands of the target DNA from each other; Cooling the reaction mixture … to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and Repeating steps (b) and (c) at least 20 times. Claim 1 is deemed not to be patent-eligible because isolated primers are not structurally different from naturally occurring DNA. Claim 2 is deemed patent-eligible, because the claim contains elements that narrow the scope of the claim and involve manipulation of the natural products.

18. Example D: Process Claim Involving Natural Principle and Natural Products The hypothetical claims recite: A method for determining whether a human patient has degenerative disease X, comprising: obtaining a blood sample from a human patient; determining whether misfolded protein ABC is present in the blood sample, whether said determining is performed by contacting the blood sample with antibody XYZ and detecting whether binding occurs between misfolded protein ABC and antibody XYZ using flow cytometry, wherein antibody XYZ binds to an epitope that is present on misfolded protein ABC but not on normal protein ABC; and diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present in the blood sample. Correlation between presence of misfolded protein ABC in blood and degenerative disease X is natural principle and blood and protein ABC are both natural products. However, antibody XYZ does not exist in nature and is not purely conventional or routine in the art. The claim recites something “significantly different” than natural principle since additional elements amount to practical application of the natural principle.

19. Example E: Process Claims Involving a Natural Principle The hypothetical claims recite: Claim 1. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder. Claim 2. A method for treating a mood disorder in a human patient, … comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder. Claim 3. A method for treating a mood disorder in an human patient, … comprising: providing a light source that emits white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder. Claims 1-3 recite the natural principle or phenomenon that white light affects human neuronal activity and claim 1 recites the natural phenomenon of sunlight. Claims 1 and 2 are NOT significantly different than natural principle as neither provides a practical application of the natural principle. However, claim 3 is significantly different because it includes a practical application.

20. Criticism of Guidance Memorandum This is the 6th attempt since August 2009 by the USPTO to issue patent eligibility guidelines. Though it carries no force of law, the guidance memorandum is an important policy document as it will be used to train patent examiners about how to examiner patent applications under 35 USC 101. The guidance memorandum was not subject to public notice or comment and have been characterized as “very destabilizing” to patent eligibility determinations.

21. Criticism of Guidance Memorandum • Serious concerns include: • The “significantly different” standard for evaluating patent eligibility of a chemical compound is not justified by Supreme Court decisions. In Myriad, cDNA was deemed patentable as it was not naturally occurring. Supreme Court said nothing about the magnitude or significance of the differences between cDNA (patent eligible) and isolated genomic DNA (patent ineligible). Also, a functional difference between the ineligible isolated genomic DNA and eligible cDNA was not required by Supreme Court. • The USPTO lists 12 factors and instructs examiners to weigh them but says weight accorded each factor “will vary based upon the facts of the application.” USPTO should apply the 12 factors to eligible and ineligible claims in precedential cases to provide guidance. • The Mayo decision emphasized preemption of laws of nature, etc. and the Federal Circuit has identified preemption as central to the analysis under 35 USC 101. The memorandum does not mention preemption (but see factor (h)).

22. Criticism of Guidance Memorandum • Serious concerns continued… • The Supreme Court emphasized that a patent eligibility analysis must be performed with respect to the claim as a whole. The memorandum never mentions weighing the claim as a whole or weighing combinations of factors. • The memorandum misapplies the machine or transformation test in its examples and does not address relevance of a chemical transformation to eligibility. • Though the Supreme Court in Myriad expressly limited its decision to patentability of isolated human genes, the USPTO applied Myriad to chemicals derived from natural sources, foods, metals and metallic compounds, minerals, natural materials, nucleic acids, organisms, proteins and peptides, and other substances found in or derived from nature.

23. More Guidelines to Come… The Supreme Court heard oral argument in Alice Corp. v. CLS Bank on March 31, 2014, and a decision is due by late June, 2014, involving patent eligibility under 35 USC 101 for computer-implemented inventions. Clearly, the USPTO will have more to say on the issue of patent eligibility. In the meantime, many difficult questions remain unanswered and examiners (and us!) remain confused. What is clear is that the list of things that are unpatentable in US is growing!

24. Thank you for your attention! Questions? Michael P. Dunnam Partner Baker & Hostetler LLP Cira Centre – 12th Floor 2929 Arch Street Philadelphia, PA 19104-2891 +1-215-568-3100 +1-215-564-8962 (direct) mdunnam@bakerlaw.com