Transcript Michael Dunnam - Current State of 35 USC 101

American Intellectual Property Law Association
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
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April 7, 2014
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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
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principle for patent eligibility and preemption of the natural
principle for non-eligibility.
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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:
1. 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
2. Complementary DNA (cDNA) is “not naturally occurring” and
claims to such synthetic gene sequences are not subject to an
exception to patent eligibility
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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.
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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 acidrelated 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 manmade variant sequence), remain eligible.”
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The USPTO indicated that it would later issue more comprehensive
guidance on patent subject matter eligibility determinations.
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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
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New guidance memorandum supersedes 6/13/13 Memorandum.
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Overall Process for Subject Matter Eligibility
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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:
1. Chemicals derived from natural sources (e.g., antibiotics, petroleum
derivatives, etc.)
2. Foods (e.g., fruits, grains, meats and vegetables)
3. Metals and metallic compounds that exist in nature
4. Minerals
5. Natural materials (e.g., rocks, sands, soils)
6. Nucleic acids
7. Organisms (e.g., bacteria, plants and multicellular animals)
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8. Proteins and peptides
9. Other substances found in or derived from nature
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March 4, 2014 Guidance Memorandum
If any of the exceptions is implicated, further analysis for “significantly different”
is required under the guidance as follows:
1. 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
2. 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 factorbased analysis used to evaluate whether undue experimentation is required to
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particular claimed invention.
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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,
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or tangentially related to the judicial exception(s).
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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)).
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Claim
recites one or more elements/steps in addition to the
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judicial exception(s) that add a feature that is more than wellunderstood, purely conventional or routine in the relevant field.
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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).
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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.
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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
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process of making cDNA is routine in the biotechnology art.
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Example A: Composition/Manufacture Claim Reciting Natural Product
The hypothetical claims recite:
1. A stable energy-generating plasmid, which provides a hydrocarbon degradation
pathway.
2. 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
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two different
hydrocarbons
as compared to naturally-occurring Pseudomonas
bacterium that can only degrade a single hydrocarbon).
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Example B: Composition v. Method Claims Each Reciting Natural Product
The hypothetical claims recite:
1. Purified amazonic acid.
2. Purified 5-methyl amazonic acid.
3. 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 patenteligibility.
Claim 3 is deemed
patent-eligible as factors b-d and f are satisfied. Particular dose and
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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.
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Example C: Composition v. Method Claims Each Reciting 2 Natural Products
The hypothetical claims recite:
1.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.
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
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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.
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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.
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The claim recites something “significantly different” than natural principle since additional
elements amount to practical application of the natural principle.
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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
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natural principle. However, claim 3 is significantly different because it
includes a practical application.
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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.
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Criticism of Guidance Memorandum
Serious concerns include:
1. 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.
2. 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.
3. The Mayo decision emphasized preemption of laws of nature, etc. and the
Federal Circuit has identified preemption as central to the analysis under 35
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USC 101.
memorandum does not mention preemption (but see factor (h)).
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Criticism of Guidance Memorandum
Serious concerns continued…
4. 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.
5. The memorandum misapplies the machine or transformation test
in its examples and does not address relevance of a chemical
transformation to eligibility.
6. 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,
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metallic compounds, minerals, natural materials,
nucleic acids, organisms, proteins and peptides, and other
substances found in or derived from nature.
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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 computerimplemented 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.
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What is clear
is that the list of things that are unpatentable in US is
growing!
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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)
[email protected]
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