IP Theory
Christina Susanto
The Patentability of Living Organisms: What is a “human organism” and should it be patentable?
I. Introduction
For many years, living organisms have been considered patentable subject matter by the
United States Patent and Trademark Office (USPTO). Applicants that have been able to satisfy
the novelty, utility, and non-obvious requirements for their inventions have been able to secure
exclusive rights to such living organisms, ranging from plants to animals. However, as of yet,
scientists and engineers have not been able to patent an invention that encompasses a “human
being.” This paper will: (1) explore the patentability of living organisms, (2) discuss the present
ban on patents for inventions involving a “human organism,” (3) discuss and determine the
meaning of “human organism,” and (4) propose an approach that should be taken by Congress
and the USPTO.
II. The Patentability of Living Organisms
Since the birth of the nation, the U.S. government has placed a great importance on
promoting science and innovation. The U.S. Constitution explicitly addresses that interest by
empowering Congress “to promote the progress of science and useful arts, by securing for
limited times to authors and inventors the exclusive right to their respective writings and
discoveries.”1 In turn, Congress began enacting various laws relating to patents, which were
1
U.S. Const. art. I, § 8
1
eventually codified in Title 35, United States Code.2 Such laws continue to specify the
appropriate subject matter and conditions for patentability, as well as empower the USPTO to
grant patents to inventions that satisfy those requirements.3 In particular, “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.”4 Simply, an inventor is granted a patent if his invention is useful,
novel and non-obvious, as well as satisfy as patentable subject matter.5
Throughout the years, courts have interpreted patentability broadly6 and respectively, a
wide range of inventions relating and encompassing living organisms have been deemed
patentable.7 Presently, the standard for patentability of a living organism, as set forth in
Chakrabarty, is whether the invention is a “nonnaturally occurring manufacture or composition
of matter-a product of human ingenuity,”8 i.e. the invention was engineered by man to do
something it cannot do naturally.9 The products of genetic engineering, as exemplified in
Chakrabarty,10 have sufficiently constituted patentable subject matter.
2
General Information Concerning Patents, United States Patent and Trademark Office (November 2011),
http://www.uspto.gov/patents/resources/general_info_concerning_patents.jsp.
3
Id.
4
35 U.S.C. § 101.
5
Matthew R. Osenga, Supreme Court Limits What Biotechnology Can be Patented, The Primerus Paradigm,
http://www.goodmanallen.com/images/uploads/PRI_PPF13_FNLweb_large1.pdf.
6
See Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (Congress’ Committee Reports show that Congress
intended statutory subject matter to include anything under the sun that is made by man).
7
Hans Sauer, Should the USPTO allow the patenting of living organisms, BIOtechNOW (September 23, 2013),
http://www.biotech-now.org/public-policy/patently-biotech/2013/09/should-the-uspto-allow-the-patenting-ofliving-organisms#.
8
Chakrabarty, 447 U.S. at 309.
9
Sauer, supra.
10
Chakrabarty, 447 U.S. at 309.
2
Through genetic engineering, the genetic makeup of cells can be changed by transferring
genes within and across species boundaries to produce improved or novel organisms.11 Through
such means, new combinations of genes may be selected and introduced into an organism to
afford an organism with new combinations of traits that do not occur in nature.12 Genetic
engineering enables scientists to introduce a much wider range of new traits into the subject
organism that exceeds the possibilities of conventional breeding,13 which only permits
characteristics to be exchanged between species that are the same or very similar.14 The scientist
can find and isolate the desired genetic characteristic, copy it through PCR (method to reproduce
selected sections of DNA),15 and then insert it into the subject DNA.16 In addition, genetic
engineering allows for precision and great selectivity, where desired characteristics can be
transferred without transferring other characteristics that would have been unavoidable under
traditional means.17
A number of living organisms, including bacteria, fungi, and other microbes, have been
patentable as long as they were engineered for a useful purpose.18 Today, many microbes have
been patented in variety of scientific and industrial applications, such as those in the production
of antibiotics19 and those engineered to break down crude oil.20 In addition, new plant varieties
11
What is Genetic Engineering?, Union of Concerned Scientists, http://www.ucsusa.org/food_and_agriculture/ourfailing-food-system/genetic-engineering/what-is-genetic-engineering.html#.VD7aHhbYtrs.
12
Id.
13
General Q&A, U.S. Food and Drug Administration (June 10, 2014),
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredA
nimals/ucm113605.htm
14
How is it done: how to produce an insect resistant tomato plant, Bionet,
http://www.bionetonline.org/english/content/ff_tool.htm.
15
PCR (Polymerase Chain Reaction), MedicineNet.com,
http://www.medicinenet.com/pcr_polymerase_chain_reaction/article.htm
16
How is it done: how to produce an insect resistant tomato plant, supra.
17
Id.
18
Sauer, supra.
19
Id.
20
Chakrabarty, 447 U.S. 303.
3
that are produced asexually have been afforded with patent protection.21 This includes new plants
produced by grafting or biological engineering techniques, such as new fruit tree varieties and
new pest- or herbicide-resistant crop varieties.22 Patent protection has even extended to animals,
such as genetically modified laboratory animals to be used in scientific research.23
III. No Patents for “Human Organisms”
Although inventions consisting of living organisms have been considered patentable, not
all living organisms have been patentable, i.e. human organisms. Congress has failed to afford
similar patent protection for inventions involving human organisms, which are typically granted
to other living organisms. In a recent reconsideration of the patent laws in the Leahy-Smith
America Invents Act in 2011 (AIA), Congress continued to prohibit “human organisms” from
being patented. In particular, in AIA § 33(a), Congress stated that “no patent may issue on a
claim directed to or encompassing a human organism.”24 However, in Congress’ blanket
exclusion of all claims directed to or encompassing a human organism, Congress created
significant ambiguity in determining the limits of the law.
Most notably, within the statute, Congress failed to explicitly define important terms that
are relevant to the interpretation of the law. In particular, Congress failed to define the term
“human organism,” “directed to,” and “encompassing,”25 which leaves the limits of such subject
matter patentability to be unknown. This especially true since the standard for patentability at the
21
Sauer, supra.
Id.
23
Bioethics and Patent Law: The Case of the Oncomouse, WIPOmagazine (June 2006),
http://www.wipo.int/wipo_magazine/en/2006/03/article_0006.html.
24
Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 33(a) (September 16, 2011),
http://www.gpo.gov/fdsys/pkg/PLAW-112publ29/pdf/PLAW-112publ29.pdf.
25
Id.
22
4
USPTO, for many years since Chakrabarty,26 depended on whether the claimed invention as
whole encompassed a human being, not a human organism.27 Up until the AIA, a claim would
only be rejected if the broadest reasonable interpretation of the claimed invention as a whole
encompasses a human being.28 Since the boundaries of the law and the reach of biotechnology
research is now dependent of the definition of “human organism,” the remainder of this section
will explore the possible interpretations of the term “human organism” and appropriately define
“directed to” and “encompassing” to conform with the Constitution’s directive to “promote the
progress of science.”
a. What is “Human?”
A human individual can easily be identified by his physical attributes. He walks upright,
he uses tools, and he utilizes speech and language to communicate.29 But, the readily apparent
physical features that society qualifies as “human” are established and dictated by the specific
information contained in deoxyribonucleic acid (DNA).30 So, the question that naturally arises is
whether the DNA itself makes an organism “human?”
DNA is the “blueprint” of the organism that transfers characteristics to subsequent
generations.31 DNA is made of a sequence of nucleotides that contains a phosphate group, a
sugar group, and one of four nitrogen bases: adenine, thymine, guanine, and cytosine.32 The
26
Ava Caffarini, Directed To or Encompassing a Human Organism: How Section 33 of the America Invents Act May
Threaten the Future of Biotechnology, 12 J. MARSHALL REV. INTELL. PROP. L. 768 (2013).
27
Id.
28
Id.
29
Human Characteristics: What Does it Mean to be Human?, Smithsonian National Museum of Natural History,
http://humanorigins.si.edu/human-characteristics
30
Genetics, Smithsonian National Museum of Natural History, http://humanorigins.si.edu/evidence/genetics
31
What’s the difference between plant DNA and animal DNA?, EarthSky (October 13, 2008),
http://earthsky.org/earth/dna-animals-plants.
32
Deoxyribonucleic Acid (DNA), National Human Genome Research Institute,
http://www.genome.gov/25520880#al-4.
5
particular sequence of nucleotides determines the specific biological instructions in the DNA.33
Specifically, the DNA sequence consists of genes, which codes for proteins, and the molecular
codes that regulate these genes.34 These particularized biological instructions make each species
unique.35 It gives rise to an organism’s development, growth and overall physiology.36 Even
small differences may result in differences in hair color, facial structure, and a number of other
traits.37
At a first glance, it appears that the particular human DNA sequence makes it
intrinsically “human.”All human individuals share the same DNA sequence with only miniscule
genetic differences (about 0.1% difference)38 and consequently, they share the same general
physiological features. Such a commonality of genes may lead to the belief that the particular
human DNA sequence is uniquely “human.” However, the striking similarity of genes among
living organisms may work against this theory.
Although plants and animals possess striking differences in physical appearance, the
DNA of plants and animals share significant similarities on a chemical level.39 For both plants
and animals, their DNA is in the same “double helix” shape and it contains the same
nucleotides.40 Consequently, plants and animals share a significant number of the same genes as
humans, e.g., chimpanzees share 98% similarity, mice have 92% similarity, fruit flies have 44%
similarity, yeasts have 26% similarity, and weeds have 18% similarity.41 The genetic similarities
33
Id.
Genetics, supra.
35
Deoxyribonucleic Acid, supra.
36
Genetics, supra.
37
Tracing Similarities And Differences In Our DNA, Putting DNA to Work, https://www.koshland-sciencemuseum.org/sites/all/exhibits/exhibitdna/intro03.jsp.
38
Genetics, supra.
39
EarthSky, supra.
40
Id.
41
See Tracing Similarities And Differences In Our DNA, supra; Genes Are Us. And Them., National Geographic,
http://ngm.nationalgeographic.com/2013/07/125-explore/shared-genes.
34
6
reflect a common ancestry that is shared by plants, animals, and fungi.42 Such differences in
physical characteristics emerge when the nucleotide sequences differ and the precise information
determines how the organism will develop, such as produce scales or leaves, or develop legs or a
stalk.43 A tiny difference can have a big effect if this difference is located in a critical gene. 44
Otherwise, the remainder of the genes is similar to human genes, and thus, such a DNA sequence
may not be uniquely “human.”
However, a human DNA sequence may still be uniquely “human” despite these
similarities. Quite possibly, the small portion of genes not shared with other living organisms
may be the crucial element that renders human individuals uniquely “human.” There remains at
least a 2% genetic difference between humans and the closest related species (the chimpanzee).45
Since even a tiny difference in DNA sequence, especially in critical genes, can have a dramatic
result in the organism, it is possible that the uniquely “human” element of DNA is contained
within the remaining 2% of the genes. Thus, even a 2% genetic disparity could cause a dramatic
difference from all other species and cause the human DNA sequence to be uniquely “human.”
If the theory that this 2% difference in human DNA makes humans uniquely “human,” it
might be possible to modify other species to contain this characteristic through genetic
engineering. In principle anything that lives can be genetically modified (animals, people, plants,
and bacteria).46 It is conceptually possible to alter animal DNA or even plant DNA to possess
that very DNA sequence or set of genes that are uniquely “human.” The process of genetic
engineering allows foreign genes to be inserted into the subject’s genes so that the subject DNA
42
Tracing Similarities And Differences In Our DNA, supra.
EarthSky, supra.
44
Tracing Similarities And Differences In Our DNA, supra.
45
Id.
46
How is it done: how to produce an insect resistant tomato plant, supra.
43
7
receives the characteristics within its own genetic code.47 So, if the small portion of human genes
that are not present in other animal DNA or plant DNA could be identified, copied, and
introduced into the animal or plant DNA, it could theoretically transfer the “human” element into
the subject’s DNA and essentially transform into it a “human.”
Though this is theoretically possible, it may prove to be difficult in practice for several
reasons. First, the transfer of characteristics is more difficult when the species are less alike.48
Genetic modifications are easiest when it is between related species.49 For instance, certain
eukaryotic sequences (particularly those with repeated sequence organization) are difficult to
propagate in bacteria because bacteria do not have similar types of DNA organization. 50 Such
structural instability causes some vectors to delete or rearrange portions of the inserted DNA.51
In addition, although human DNA fragments have been introduced into plants to create
vaccines,52 a transfer of sizable portion of DNA to the subject DNA (2% dissimilar genes to
chimpanzee DNA or 88% to a weed DNA)53 may prove to be unfeasible. For instance, plasmid
vectors have a severely limited capacity to insert large DNA fragments.54 Next, not all
characteristics can be transferred because some genes rely on its interaction with many other
genes to function correctly.55 Presently, the technology has not progressed enough to recreate the
necessary interactions for these desired characteristics.56
47
Id.
Id.
49
Id.
50
Tom Strachan & Andrew P. Read, Human Molecular Genetics (2d ed. 1999),
http://www.ncbi.nlm.nih.gov/books/NBK7579/
51
Id.
52
Linda MacDonald Glenn, Ethical Issues in Genetic Engineering and Transgenics, Actionbioscience (November
2013), http://www.actionbioscience.org/biotechnology/glenn.html.
53
See Tracing Similarities And Differences In Our DNA, supra.
54
Strachan, supra.
55
How is it done: how to produce an insect resistant tomato plant, supra.
56
Id.
48
8
In sum, the sequence of human DNA itself may be uniquely “human” for its genetic
differences (at least 2% with its closest genetic relative)57 with other living organisms. Although
human DNA shares the majority of its genes with other living organisms,58 such a relatively
minor difference (at least 2% genetic disparity) may still be the cause of unique “human”
characteristics, such as walking upright, possess the ability to use tools for acquiring food, and
possess large, complex brains.59 Although genetic engineering is presently able to insert
fragments of human DNA into the DNA of other living organisms, it would still be insufficient
to constitute “human” since it does not incorporate the uniquely “human” portions and it could
not be synthetically created to capture all of the differences between humans and other living
organisms. Thus, “human” should be defined by the unique DNA sequence that human
organisms possess.
b. What is a “Human Organism?”
Since Congress left the term “human organism” undefined, the term “human organism”
will be defined by its individual parts. As discussed above, the term “human” can be defined by
its entire unique DNA sequence that gives rise to uniquely “human” characteristics. In biology,
the term “organism” is defined as the whole, living being60 and a system with many parts that
depend on each other and work together.61 There are several characteristics that are common to
an organism: “movement, feeding, respiration, growth, reproduction, and sensitivity.”62 A
57
See Tracing Similarities And Differences In Our DNA, supra.
Id.
59
See Human Characteristics: What Does it Mean to be Human?, supra.
60
Dianne N. Irving, Definitions of a “Human Organism” and a “Cell”, lifeissues.net (October 2004),
http://www.lifeissues.net/writers/irv/irv_78definitions.html.
61
Robert Gunderman & John Hammond, Patent Claims Directed to or Encompassing a Human Organism—Where
Law, Morality, Ethics, and Religion Meet, The Limited Monopoly, http://www.patentinnovations.com/documents/201408LimitedMonopoly-PatentingLifeForms.pdf.
62
Irving, supra.
58
9
complex organism may be comprised of more than one cell.63 Thus, in joining the two terms
together, “human organism” may be defined as a whole, living being that contains one or more
cells consisting of its entire uniquely human DNA sequence.
c. “Directed to” or “Encompassing” a Human Organism: What are the Limits of
Patentability?
Since the terms “directed to” and “encompassing” were left undefined in the AIA, 64 the
plain meanings of the terms can be used and the direct implications of such limitations on
biological research with human organisms will be assessed.
When using the plain meaning of these terms, it is conceivable that the AIA prohibition
on patenting human organisms could broadly stretch to encapsulate inventions containing human
DNA or another human component. The plain meaning of “directed” is to aim in a particular
direction65 and “to” is defined as “in the direction of.”66 Thus, “directed to” can be interpreted as
“to aim in the direction of something.” The term “encompassing” is defined as surrounding and
having or holding within.67 Thus, under the plain meaning of the statute, it is conceivable that if
an invention holds within it human DNA or aims in the direction of use on the human body, it
could be per se unpatentable.
Such an interpretation is not entirely unreasonable given the recent decision by the
Supreme Court in 2013. In Myriad, the Supreme Court held that isolated human DNA was
unpatentable despite it being not naturally occurring and it qualifying for patent protection under
“manufactures” or “compositions of matter.”68 The inventors at Myriad discovered the precise
location and sequence of two human breast cancer genes, and in turn, they isolated the DNA and
63
Id.
§33(a)
65
“Direct” http://www.oxforddictionaries.com/us. Oxford Dictionary, 2014. Web. 18 October 2014.
66
“To” http://www.oxforddictionaries.com/us. Oxford Dictionary, 2014. Web. 18 October 2014.
67
“Encompass” http://www.oxforddictionaries.com/us. Oxford Dictionary, 2014. Web. 18 October 2014.
68
See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013); Osenga, supra.
64
10
created cDNA copies.69 Although the isolated human DNA and cDNA do not naturally exist in
separated and isolated from the remainder of the human genome, the isolated human DNA was
nonetheless unpatentable (the cDNA was patent eligible.)70
Although Myriad was decided under subject matter patentability under § 101, not AIA §
33, the decision may nonetheless have an impact on the question of patentability of claims
“directed to” or “encompassing” a human organism. First, in the decision, the Court states that it
would not afford deference to the PTO’s past practice of awarding gene patents (in reference to
utility patents for new plant breeds under the Plant Patent Act of 1930) because the previous
decisions were under a different Act that did not mention genes, much less isolated DNA.71 The
Court reaffirmed that “none of the funds appropriated or otherwise made available under the Act
may be used to issue patents on claims directed to or encompassing a human organism.” Second,
even though the Court found cDNA to be patentable, it placed a significant limitation on its
patentability. The Court stated “cDNA is not a ‘product of nature’ and is patent eligible under §
101, except insofar as very short series of DNA may have no intervening introns to remove when
creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural
DNA.”72 Thus, the Court has limited the patentability of cDNA to only when the synthetically
produced DNA is not too short.73 It appears that the Court may deny a patent on a cDNA of a
human gene, even if it is man-made.
This new decision by the Court along with the AIA bar on patenting claims directed to or
encompassing a human organism could have far reaching effects on future inventions that
69
Osenga, supra.
Id.
71
Myriad, 133 S. Ct. at 2118.
72
Myriad, 133 S. Ct. at 2119.
73
Gene Quinn, Dolly the Cloned Sheep Not Patentable in the U.S., IPWatchdog (May 8, 2014),
http://www.ipwatchdog.com/2014/05/08/dolly-the-cloned-sheep-not-patentable-in-the-u-s/id=49471/.
70
11
incorporate human fragments into other living organisms or even inventions that are aimed in the
direction of human treatment. Such inventions that could potentially be precluded from being
granted patent protection include: personalized medicine, human derivatives (e.g. hormones, and
antibodies), artificial organs, and etc.74 This is especially true for human gene patents because
they are “directed to” a human organism since they are typically used to develop tests for genetic
abnormalities in humans.75 In addition, although the remarks on the Record for the AIA indicate
that AIA § 33 would not alter the standing patentability standards and treatment of claims,76 this
particular amendment was introduced to cover all human organisms, including human
embryos.77
IV. Proposed Approach to Patenting a “Human Organism”
The present law is far from clear. With the ambiguous terms and interpretations of the
terms “human organism,” “directed to,” and “encompassing” in AIA § 33(a), the statute certainly
requires an amendment that establishes very specific restrictions. The remainder of this section
will propose the boundaries of the patentability for human organism claims that align with the
two prominent concerns of maintaining the value of human life and promoting scientific
innovation.
In considering the appropriate boundaries, the underlying concerns of morality, ethics,
religion, and the law play a significant role. Many opponents to the patenting of human
74
Caffarini, supra.
Id.
76
Joe Matal, A Guide to the Legislative History of the America Invents Act: Part I of II,
http://www.uspto.gov/aia_implementation/guide-to-aia-p1.pdf (Section 33 should not affect: “1. Any chemical
compound or composition, whether obtained from animals or human beings or produced synthetically, and wither
identical to or distinct from a chemical structure as found in an animal or human being, including but not limited to
nucleic acids, polypeptides, proteins, antibodies and hormones;…4. A nonhuman organism incorporating one or
more genes taken from a human organism, including but not limited to a transgenic plant or animal, or animal
models used for scientific research.”)
77
Caffarini, supra.
75
12
organisms raise concerns that in the creation of quasi-human life, the value of human life
degrades when scientist simply “play God” in the laboratory.78 There is significant fear that with
genetic engineering, humans would be enabled to direct evolution and “arrogantly tamper with
nature.”79 In particular, new breeds can be created by blending animal and human DNA without
much consideration of the rights and protections that should be afforded to these new living
entities.80 In addition, opponents also say since a patent is a property right and owning another
person is considered slavery, patenting human life would violate the 13th Amendment to the
Constitution.81 So, in this respect, the granting of patents to claims directed to or encompassing
of a human organism should be very limited.
On the other hand, the concern of progressing scientific endeavors is equally as
important. With hopes of driving scientific innovation, patents are granted to facilitate and
provide incentive to the free flow of information within the research community.82 The granting
of a patent to an inventor provides assurance that great investments of time and effort may be
recouped down the line.83 This is particularly true for innovation in the biotechnology field
where the costs of scientific development are exceptionally high.84 Presently, the patentability of
living organisms in transgenic biotechnology has already presented a wealth of information and
significant benefit to patients and society in general.85 As a result, valuable vaccines and
therapeutic antibodies have been created from plant-animal-human transgenes.86 Furthermore,
recent advancements in DNA sequencing has allowed progress in personalized medicine and
78
Gunderman, supra.
Caffarini, supra.
80
Glen, supra.
81
Gunderman, supra.
82
Nikki Buck, Greed is Good, for Patients: How the Biotechnology Industry Saves Lives, One Gene Patent at a Time,
11 NW. J. TECH. & INTELL. PROP. 61 (2013), http://scholarlycommons.law.northwester.edu/njtip/vol11/iss2/5.
83
Sauer, supra.
84
Buck, supra.
85
Glen, supra.
86
Id.
79
13
treatment.87 In this light, the patentability of claims containing human organisms should be
broadly interpreted.
In reconciling the two opposing interests, the following considerations should be adopted
to promote scientific research and medical advancement, as well as respect human life. First,
Congress should readopt the pre-AIA approach to human beings—i.e. deny inventions that claim
a human organism in an unaltered, un-manipulated state. As in Kamrava, the patent was denied
since some of the claims included the human organism itself.88 The invention claimed a catheter
that includes the embryo, which was properly denied for including the embryo as a component of
the invention.89 Simply, the invention should disclaim any patent protection for human
organisms, and solely direct claims towards the non-human claims.
Second, Congress should only deny patent protection for claims that seek to patent the
whole human DNA sequence or the product that results from it, whether it is natural or synthetic.
For instance, where the whole human sequence is used for producing identical human clones, a
patent should be denied. For instance, as in the case of Dolly the Sheep, the claimed invention
was rightfully denied a patent for failing to meet patentable statutory subject matter even though
it was made by man.90 The claimed invention merely constituted a natural phenomenon that did
not possess “markedly different characteristics than any found in nature;” it was merely an exact
copy of what occurs in nature.91 Likewise, a human clone containing an exact replica of whole
human DNA sequence should be unpatentable for merely copying nature.
87
Osenga, supra.
Dennis Crouch, Patents Encompassing a Human Organism, PatentlyO (December 2, 1012),
http://patentlyo.com/patent/2012/12/ex-parte-kamrava.html.
89
Id.
90
See In re Roslin Inst. (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2004); Quinn, supra.
91
Id.
88
14
Third, Congress should permit the patenting of inventions that encompass single human
genes or a single set of human genes. These small fragments of human DNA are insufficient to
constitute a uniquely “human” element. As previously mentioned, the uniquely human element is
the whole human DNA sequence, rather than its individual genes that it shares in common with
other living organisms. The use of a human gene would not necessarily give rise to a human
organism. Furthermore, a prohibition against using any fragment human DNA would be harmful
to scientific advancement that has already proven to be fruitful to society.
V. Conclusion
The most effective way to clear up the ambiguity around the language and meaning of the
AIA is to clearly incorporate these considerations in an amendment and adopt it into practice. A
middle ground approach should be taken when determining the patentability of claims directed
or encompassing human organism so that human life can be respected without stifling beneficial
scientific research.
15