INDUSTRIAL BIOTECHNOLOGY
Volume 11, Number 2, 2015
© Mary Ann Liebert, Inc.
Patent Update
Patent Eligibility of Nature-Based Products:
Current View of the United States Patent & Trademark Office
Cong Yao1, Craig Countryman,2 and J. Peter Fasse1
Fish & Richardson PC, Boston, MA1 and San Diego, CA2
T
he last few years have seen significant changes to the
law of what constitutes patent-eligible subject matter
under 35 USC x 101 (Section 101). The Supreme
Court’s most recent decision in the area—Alice Corp.
Pty. Ltd. v. CLS Bank Int’l—reaffirmed that courts should use a
two-step analysis for determining whether inventions in all areas
of technology are eligible for a patent.1 This broad pronouncement, however, has left significant uncertainty for lower courts
and the United States Patent and Trademark Office (USPTO),
which must now apply the standard on a case-by-case basis. The
Patent Office initially issued guidance in March (the March
Guidance) and June 2014 to help examiners determine whether
new patent applications are eligible, but these were met with a
wave of criticism from practitioners.
Responding to the criticism, the Patent Office recently issued
a new ‘‘Interim Guidance on Patent Subject Matter Eligibility’’
on December 16, 2014 (the December Guidance), along with a
handful of examples of how to apply that guidance to ‘‘naturebased products.’’2 Examiners have been instructed to apply this
guidance going forward. This article summarizes the new December Guidance and selected examples, provides several
strategies for prosecution, and discusses a recent Federal Circuit
opinion that offers a somewhat different patent eligibility
analysis than the USPTO’s December Guidance.
The USPTO’s December Guidance
In a nutshell, the December Guidance is more lenient on
claims covering nature-based products compared to the March
Guidance. It instructs examiners to apply the Supreme Court’s
two-step test by asking a set of three questions, which are set
forth below:
.
.
.
Step 1: ‘‘Is the claim to a process, machine, manufacture or
composition of matter?’’ If yes, go to Step 2. If no, the
claim does not cover subject that is eligible for a patent.
Step 2A: ‘‘Is the claim directed to a law of nature, a natural
phenomenon, or an abstract idea (judicially recognized
exceptions)?’’ If no, the claim is eligible for patent protection, and the claim should be examined for patentability.
If yes, go to Step 2B.
Step 2B: ‘‘Does the claim recite additional elements that
amount to significantly more than the judicial exception?’’
If yes, the claim is eligible for patent protection and should
DOI: 10.1089/ind.2015.1504
be examined for patentability. If no, the claim is not eligible for patent protection.
The analysis under the new framework has three main changes
from the March Guidance. First, the December Guidance asks in
Step 2A whether the claim is ‘‘directed to’’ a judicial exception,
whereas the March Guidance was broader and asked ‘‘does the
claim recite or involve’’ a judicial exception. Second, the
markedly different characteristics analysis in Step 2A is now
based on structural, functional, and other non-structural properties, and not just on structure, as in the March Guidance. Third,
the December Guidance asks in Step 2B whether the additional
elements are ‘‘significantly more’’ than the judicial exception,
whereas the March Guidance asks if the claim recites something
‘‘significantly different’’ than the exception. We address each of
these changes in further detail below.
STEP 2A - THE ‘‘DIRECTED TO’’ INQUIRY
To determine whether a specific claimed subject matter is
‘‘directed to’’ a judicial exception under the December Guidance, an examiner must identify a judicial exception and then
decide whether the claimed subject matter is ‘‘directed to’’ the
judicial exception. The December Guidance acknowledges that
the identification of a judicial exception need not be precise:
‘‘[I]t is sufficient for this analysis to identify that the claimed
concept aligns with at least one judicial exception.’’3 After
identifying the judicial exception, the more important question
is what exactly ‘‘directed to’’ means.
The answers in the December Guidance depend on the judicial exception at issue. For ‘‘abstract ideas,’’ the December
Guidance provides no satisfactory answer except to parrot
specific facts in the Supreme Court cases. Futhermore, it notes
that ‘‘[a]bstract ideas have been identified by the courts by way
of example, including fundamental economic practices, certain
methods of organizing human activities, an idea ‘of itself,’ and
mathematical relationships/formulas.’’
A prominent change from the March Guidance, however,
comes from the December Guidance’s ‘‘directed to’’ inquiry
regarding ‘‘laws of nature’’ and ‘‘natural phenomena.’’ This
change makes it easier for nature-based claims to pass muster
under Section 101. In particular, a nature-based product is not
‘‘directed to’’ a law of nature or a natural phenomenon if it has
‘‘markedly different characteristics compared to what occurs in
nature,’’ thus avoiding the need to address Step 2B. The December Guidance then gives specific instructions on how to
apply this test: 1) ‘‘the markedly different characteristics analysis should be applied to the resultant nature-based combination,
ª M A R Y A N N LI E B E R T , IN C . VOL. 11
NO. 2 APRIL 2015
INDUSTRIAL BIOTECHNOLOGY 91
YAO, COUNTRYMAN, AND FASSE
rather than its component parts;’’4 2) ‘‘the characteristics of the
claimed nature-based combination are compared to the characteristics of the components in their natural state;’’5 and 3)
‘‘[m]arkedly different characteristics can be expressed as the
product’s structure, function, and/or other properties.’’6
Under this standard, most patent-eligible claims in the new
examples possess markedly different characteristics, which is
a significant change from the USPTO’s analysis of many of
these examples in the March Guidance, where most were not
patent eligible. One possible reason is that the ‘‘markedly
different’’ inquiry now permits consideration of functional
and other non-structural changes, whereas in the March Guidance only structural changes were considered to be relevant.
The bottom line is that if the claimed nature-based product is
not ‘‘directed to’’ a judicial exception because it possesses
‘‘markedly different characteristics,’’ the subject matter is
patent-eligible.
STEP 2B - THE ‘‘SIGNIFICANTLY MORE’’ INQUIRY
Under the December Guidance, if a patent claim is indeed
‘‘directed to’’ a judicial exception, the examiner must then decide whether the patent claim is nevertheless patent-eligible by
reciting ‘‘significantly more’’ than the judicial exception. Like
the March Guidance, the December Guidance provides a legion
of factors for the ‘‘significantly more’’ inquiry. Factors that tend
to support patent-eligibility include: improvements to another
technology or technical field; improvements to the functioning
of a machine, e.g., computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a
transformation or reduction of a particular article to a different
state or thing; adding a specific limitation other than what is
well-understood, routine, and conventional in the field, or adding unconventional steps that confine the claim to a particular
useful application; or other meaningful limitations beyond
generally linking the use of the judicial exception to a particular
technological environment.
Factors that cut against patent-eligibility include the addition
of the words ‘‘apply it’’ (or an equivalent) with the judicial
exception, or the mere inclusion of instructions to implement an
abstract idea on a computer. Other factors may involve simply
appending well-understood, routine, and conventional activities
previously known to the industry–specified at a high level of
generality–to the judicial exception; e.g., a claim to an abstract
idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine, and
conventional. Additional factors might include appending insignificant extra-solution activity to the judicial exception, e.g.,
mere data gathering in conjunction with a law of nature or abstract idea. Another example would be generally linking the use
of the judicial exception to a particular technological environment or field of use.
Given how numerous the factors could be, whether a claim is
patent-eligible will likely depend on the specific facts and claim
language. Applicants will want to gather as much supporting
evidence as they can for the factors supporting patentability. At
the same time, they should take care to draft their claim so it
does not look like they implicate factors that would cut against
patentability.
92 INDUSTRIAL BIOTECHNOLOGY A P R I L 2 0 1 5
THE OVERARCHING POLICY CONSIDERATIONS
In the December Guidance, the USPTO emphasizes the policy that patent claims should avoid tying up, or pre-empting,
anything that falls within one of the judicial exceptions and that,
as long as claims do this they are patent-eligible. For example,
under Step 2A—i.e., whether a claim is directed to a judicial
exception—the USPTO states that a claim is not directed to the
judicial exceptions if the claim is ‘‘directed to inventions that
clearly do not seek to tie up the judicial exception.’’7 The December Guidance further provides that a full Section 101 analysis is unnecessary if a claim ‘‘may or may not recite a judicial
exception but, when viewed as a whole, clearly does not seek to
tie up any judicial exception such that others cannot practice
it.’’8 This is referred to as the ‘‘streamlined’’ eligibility analysis.
Analysis of the December Guidelines
NEW EXAMPLES
Although the standards recited above give some guidance on
how examiners will determine patent-eligibility, the real insight
into the practical effect of the December Guidelines comes from
analyzing the examples. Applicants should become familiar
with the examples most pertinent to their field and consider
whether they should argue patentability by analogy to an appropriate example. The following examples are particularly
relevant to the area of industrial biotechnology.
Pomelo juice—slow spoiling is a marked different characteristic. One example deals with two claims involving juice from the
pomelo fruit. The first claim, which is merely ‘‘a method
comprising providing a pomelo fruit’’ is patent-ineligible. This
claim ‘‘focuses on a natural product per se [and] is treated as a
composition claim of that natural product.’’ The composition
claimed is pomelo fruit and has no markedly different characteristics from the natural product. But the second claim, which
covers ‘‘a beverage composition comprising pomelo juice and
an effective amount of an added preservative,’’ is patent eligible.
The added preservative makes the juice spoil slower than the
natural juice—the ‘‘slow spoiling’’ is a markedly different
characteristic of the claimed composition and thus makes the
claim patent-eligible.
This example illustrates that as long as the composition as a
whole has markedly different characteristics, the claimed subject matter is not ‘‘directed to’’ a judicial exception, even though
one of its component parts may come from nature. This saves the
claim from the ‘‘significantly more’’ test, an apparently more
stringent requirement.
Purified proteins—change of one amino acid is a markedly different characteristic. Another example states that changing even one
amino acid of a natural protein results in a modified protein that
is patent-eligible. This change constitutes a markedly different
characteristic, regardless of whether it is accompanied by a
change in biological or pharmacological function, or a change in
chemical or physical properties. In addition, a new crystal form
of a protein that is different from the protein’s natural crystal
form is a markedly different characteristic if the new crystal
form provides a new function. Unfortunately, from this example
PATENT ELIGIBILITY OF NATURE-BASED PRODUCTS
it remains unclear whether a new structural form without a new
function would be patent-eligible.
Antibodies—an antibody defined by a non-naturally occurring sequence is markedly different even if nature might randomly create
such a sequence. The December Guidance first confirms that
non-naturally occurring antibodies are markedly different: ‘‘an
antibody to protein S, wherein the antibody is a human antibody’’ is patent-eligible, because no human antibodies to protein
S are naturally occurring. Likewise, chimeric antibodies and an
antibody with even one amino acid change compared to a naturally occurring antibody are both markedly different from their
naturally occurring counterparts; i.e., they are not ‘‘directed to’’
the judicial exceptions and thus pass muster under Section 101.
More interestingly, a claim to an antibody that recites a specific sequence that is not known to exist in nature is patent
eligible even if ‘‘nature might randomly create.[an] antibody
having the [claimed sequence].’’ Further, ‘‘this mere possibility
does not bar the eligibility of this claim.’’ To invalidate this
claim under Section 101, an examiner must show that the antibody with the particular sequence actually exists in nature.
Cells—expression of a new gene is a markedly different characteristic; significantly more analysis. In this example, a claim to a
man-made, isolated cell is not patent-eligible, but a change in
phenotype caused by human manipulation can result in a
markedly different characteristic. For example, if a cell normally found in nature were altered to express a gene that is
always silent when the cells are in the human body, then claims
to the cells that recite the altered gene expression would be
eligible for patent protection. In addition, a faster growth rate or
other functional difference compared to naturally occurring
cells can be a markedly different characteristic.
This example also provides a detailed analysis of how a
‘‘significantly more’’ inquiry should be conducted. The hypothetical is ‘‘a composition comprising a population of isolated
man-made human pacemaker cells in a biocompatible threedimensional scaffold.’’ First, the composition claim in this example was said to contain no markedly different characteristics
compared to the cells or scaffold as found in nature, because
none of the cells, the scaffold, or the combination of the two
possess any added function or a structural difference compared
to the naturally occurring counterparts. The claim is thus ‘‘directed to’’ the judicial exceptions of law of nature and natural
phenomenon. The examiner should then proceed to the Step 2B
inquiry and decide whether the combination recites ‘‘significantly more’’ than the naturally occurring counterparts.
According to this example, the claim passes muster under the
‘‘significantly more’’ inquiry for the following three reasons: 1)
the scaffold’s use in combination with the cells is not required
for growing or using the cells; 2) the cells’ use in combination
with the scaffold confines the claim to a particular useful application of the scaffold, because the cells are not required for all
practical uses of the scaffold; and 3) the combination improves
the relevant technology of regenerative medicine. Thus, the
claim amounts to significantly more than the judicial exception
itself.
SUMMARY OF THE EXAMPLES
The new Examples contain far more patent-eligible claims
than the March Guidance. Notably, most of the patent-eligible
claims meet the test of Step 2A by possessing markedly different
characteristics. However, the new Examples shed little light on
the ‘‘significantly more’’ inquiry. Of all the hypotheticals that
proceed to the ‘‘significantly more’’ inquiry of Step 2B, only the
‘‘Cells’’ example meets the standard; and the analysis is far from
comprehensive. For the other examples that get to Step 2B, the
facts and/or claims simply fail to recite additional features that
could add significantly more to the exception, and so the claims
are ineligible for patent protection.
The Federal Circuit’s View
Just one day after the publication of the December Guidance,
the Federal Circuit decided a case invalidating claims of DNA
primers (In re BRCA1- & BRCA2-Based Hereditary Cancer Test
Patent Litigation).9 The Federal Circuit found that DNA primers
have similar functions as their naturally occurring counterparts;
all of them bind to complementary sequences. The court also
ruled that the primers have the same structures as their naturally
occurring counterparts. The court then stated that ‘‘a DNA
structure with a function similar to that found in nature can only
be patent eligible as a composition of matter if it has a unique
structure, different from anything found in nature.’’10 Based on
this rationale, the Court concluded that ‘‘[p]rimers do not have
such a different structure and are patent ineligible.’’10
In addition, the Federal Circuit found the screening method
claims using the invalidated primers to be ineligible as ‘‘abstract
ideas.’’11 The court initially analyzed the first paragraph of each of
these method claims and concluded that the comparisons in these
first paragraphs ‘‘are directed to the patent-ineligible abstract idea
of comparing BRCA sequences and determining the existence of
alterations.’’12 The court then concluded that the second paragraphs ‘‘set forth well-understood, routine and conventional activity engaged in by scientists at the time of Myriad’s patent
applications.’’13 Based on these conclusions the court held that the
‘‘first paragraphs of [the screening method] claims 7 and 8, as we
held in our 2012 Myriad opinion, claim abstract comparisons’’ and
that ‘‘the second paragraphs recite only routine and conventional
steps.’’14 The Court then reached the holding that ‘‘the claims,
therefore, are directed to patent-ineligible subject matter.’’15
In reaching this decision, the Federal Circuit analyzed only
structure and a naturally occurring function. The Court failed,
however, to consider other properties or the man-made uses. It will
be interesting to see what impact, if any, this decision has on how
the USPTO instructs examiners to apply its December Guidance.
Obtaining Patent Protection
The key for patent applicants that want to survive a Section
101 challenge for a claim that involves a natural product will be
to focus on the ‘‘markedly different characteristics’’ inquiry.
The December Guidance sets a relatively flexible standard,
because the differences can come from the ‘‘product’s structure,
function, and/or other properties.’’6 A new crystal form, new
‘‘slow spoiling’’ properties, and changes of a single amino acid
are all ‘‘markedly different characteristics.’’ As long as a claim
ª M A R Y A N N L I E B E R T , I N C . VOL. 11
NO. 2 APRIL 2015
INDUSTRIAL BIOTECHNOLOGY 93
YAO, COUNTRYMAN, AND FASSE
contains such ‘‘markedly different characteristics,’’ the claim
should meet the Section 101 requirements without the need to
run the gauntlet of the ‘‘significantly more’’ inquiry.
Other suggestions are to avoid red-flag terms in your specification, e.g., routine, conventional, well-understood, and wellknown. It is also important, if possible and appropriate, to define
terms carefully (e.g., ‘‘pharmaceutically acceptable carrier’’) to
exclude natural products. When drafting your application, try to
get the inventors to explain any structural and/or functional
differences between their new products and compositions and
any similar natural products and clearly describe those differences in the specification.
When drafting claims, try to include structure in your claims, at
least to the extent that is consistent with the invention and your
client’s business objectives. Even if the USPTO examiners are
supposed to consider functional differences, they may not, and it
appears that the courts may also prefer to see structural differences in patent claims. If the invention includes a novel reagent,
consider eliminating from at least some of the claims any comparing or correlation steps. Also, you should consider spelling out
particular steps/reagents in otherwise established procedures in
your claims, as those specific steps may provide a sufficient
limitation under a ‘‘significantly more’’ analysis. In addition, in
all your claims make sure that you are reciting more than simply
informing an actor (e.g., a doctor) to consider the natural law.
Your claim must apply the natural law with specificity.
the Supreme Court and was involved in the briefing for both Mayo Collaborative
Services v. Prometheus Laboratories, Inc. and Association for Molecular
Pathology v. Myriad Genetics, Inc.
J. Peter Fasse, Esq. is a principal in the Boston, MA office of Fish & Richardson PC,
where he has counseled clients on issues of patent law since 1987, specializing in
the areas of life science, medical, and green technologies. Phone: (617) 5217802; Email: fasse@fr.com
The content of this editorial is not intended as legal or financial advice. Views
expressed are those of the authors and should not be construed as necessarily
representative of Fish & Richardson PC, Industrial Biotechnology journal, Mary
Ann Liebert, Inc., publishers, or their affiliates. No endorsement of any entity or
technology is implied.
REFERENCES
1. 134 S. Ct. 2347 (2014).
2. USPTO, 2014 Interim Guidance on Patent Subject Matter Eligibility. Available
at: http://federalregister.gov/a/2014-29414 (Last accessed February 2014)
[hereinafter December Guidance].
3. December Guidance at *12.
4. December Guidance at *16.
5. December Guidance at *17.
6. December Guidance at *18.
7. December Guidance at *11.
8. December Guidance at *24.
9. 774 F.3d 755, 761 (Fed. Cir. 2014).
10. Id. at 761.
Cong Yao, Esq. is a litigation associate in the Boston, MA office of Fish &
Richardson PC. He has extensive background in biotechnology, specializing in the
areas of genetics, diagnostics, pharmaceuticals, and medical devices. Phone:
(617) 956-5956; Email: yao@fr.com
Craig Countryman, Esq. is a principal in the San Diego, CA office of Fish &
Richardson PC. His practice focuses on cases involving pharmaceuticals and
biotechnology. He has significant appellate experience at the Federal Circuit and
94 INDUSTRIAL BIOTECHNOLOGY A P R I L 2 0 1 5
11. Id. at 761–65.
12. Id. at 763.
13. Id. at 764.
14. Id. at 765
15. Id.