2. 234 AIPLA Q.J. Vol. 30:233
1
See Diamond v. Chakrabarty, 447 U.S. 303, 206 U.S.P.Q. (BNA) 193
(1980).
2
Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5,
2001)[hereinafter Utility Guidelines]; Guidelines for Examination of
Patent Applications Under the 35 U.S.C. § 112, ¶ 1, “Written
Description” Requirement, 66 Fed. Reg. 1099 (Jan. 5, 2001)[hereinafter
Written Description Guidelines]. The statutory basis for the utility
requirement is 35 U.S.C. § 101, which requires that a patentable
invention be “useful.” 35 U.S.C. § 101 (2000). The statutory basis for the
written description requirement is 35 U.S.C. § 112, ¶ 1, which requires
that the patent application contain a written description of the
invention. 35 U.S.C. § 112, ¶ 1 (2000).
I. INTRODUCTION
One of the most valuable assets a pharmaceutical or biotechnology
company can own is a proprietary position on genetic material that will
provide the foundation for developing commercial biological and chemical
products. The appropriate requirements for patenting genetic material are
a subject of vigorous national and international debate.
In the United States, the basic criteria for patenting advancements in
genetic research have been established by the United States Court of
Appeals for the Federal Circuit, following the United States Supreme Court
decision in Diamond v. Chakrabarty.1
However, several organizations have
expressed concerns that unduly broad genetic patents still may be granted
and thereby stifle innovation.
In an attempt to address such concerns and to account for Federal
Circuit precedent, the United States Patent and Trademark Office (“PTO”)
hasrecentlyissuedguidelinesrelating totheU.S.patentabilityrequirements
of“utility” and“writtendescription”(collectively,the“Guidelines”).2
These
Guidelines address various comments made about an earlier version called
3. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 235
3
See Utility Guidelines, supra note 2, at 1092.
4
See id.
5
See generally Utility Guidelines, supra note 2; Written Description
Guidelines, supra note 2.
6
See Utility Guidelines, supra note 2, at 1098; Written Description
Guidelines, supra note 2, at 1104.
7
See Utility Guidelines, supra note 2, at 1097; Written Description
Guidelines, supra note 2, at 1104.
8
“Prosecution” before the PTOrefers totheadministrativeprocedurefor
seeking allowance of a patent application.
9
See generally Utility Guidelines, supra note 2, at 1092; Written
Description Guidelines, supra note 2, at 1099. The statutory basis of the
non-obviousness requirement is 35 U.S.C. § 103, which forbids the
issuance of a patent when the differences between the subject matter of
the Revised Interim Utility Examination Guidelines.3
The Guidelines may
be found in the Federal Register, along with the comments and the PTO’s
responses.4
While the Guidelines themselves are not specifically limited to
the examination of patent applications for biotechnology inventions, many
of the comments and responses do address biotechnology-specific issues.5
The PTO has not officially promulgated the Guidelines through
notice and comment rulemaking, and thus, the Guidelines do not have the
force of law.6
They do, however, represent the PTO’s current understanding
of the statutory requirements of utility and written description.7
As a
supplement to Federal Circuit precedent, these sources are helpful to
understandandtoplantheprosecution ofbiotechnologypatentapplications
at the PTO8
and may also be of use in litigating biotechnology patents.
The newly-issued PTO examination Guidelines do not expressly
address the patentability requirement of non-obviousness.9
However, non-
4. 236 AIPLA Q.J. Vol. 30:233
the patent and that of the prior art are such that the subject matter of
the patent would have been obvious to one of ordinary skill in the
relevant art. 35 U.S.C. § 103 (2000).
10
Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1567, 43
U.S.P.Q.2d (BNA) 1398, 1405 (Fed. Cir. 1997).
11
35 U.S.C. § 101 (2000).
obviousness is a critical issue in biotechnology, especially considering the
recent publication of nearly complete genome nucleotide sequences of
various organisms. Such organisms include the fruit fly Drosophila
melanogaster, the nematode worm Caenorhabditis elegans, the flowering plant
Arabadopsisthalianaand,mostnotably,Homosapiens. Inaddition,theFederal
Circuit has noted the intimate relationship between written description and
obviousness,havingstatedinthebiotechnologycontextthat“[a]description
that does not render a claimed invention obvious does not sufficiently
describe that invention for purposes” of the written description
requirement.10
Therefore, as a matter of logic, a disclosure must render a
claimed invention obvious to satisfy the written description requirement.
In this article, we discuss the implications of the newly-issued
examination Guidelines with respect to biotechnology inventions. We also
address the relationship between these Guidelines and the law of
patentability established by the Federal Circuit.
II. UTILITY, WRITTEN DESCRIPTION, AND OBVIOUSNESS
The statutory basis for utility is 35 U.S.C. § 101, which embodies the
patentability requirement that inventions be “useful.”11
Section 101 states:
“Whoever invents or discovers any new and useful process, machine,
manufacture,orcompositionofmatter,oranynewandusefulimprovement
thereof, may obtain a patent therefor, subject to the conditions and
5. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 237
12
Id.
13
Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1571,
24 U.S.P.Q.2d (BNA) 1401, 1412 (Fed. Cir. 1992); see also Juicy Whip, Inc.
v. Orange Bang, Inc., 185 F.3d 1364, 1366, 51 U.S.P.Q.2d (BNA) 1700,
1702 (Fed. Cir. 1999).
14
In re Ziegler, 992 F.2d 1197, 1200, 26 U.S.P.Q.2d (BNA) 1600, 1603 (Fed.
Cir. 1993)(citing Cross v. Iizuka, 753 F.2d 1040, 1044, 224 U.S.P.Q.
(BNA) 739, 742 (Fed. Cir. 1985)).
15
35 U.S.C. § 112, ¶ 1 (2000).
16
See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 U.S.P.Q.2d
(BNA) 1111, 1116 (Fed. Cir. 1991).
requirements of this title.”12
Historically, the Federal Circuit has not found
the utility requirement to pose a major hurdle to patentability; the Federal
Circuit stated that “[t]o violate [section] 101 the claimed device must be
totally incapable of achieving a useful result.”13
However, the Federal
Circuit has also said that a patentable invention must have a substantial or
practical utility that must be disclosed where such utility would not be
obvious.14
The“writtendescription”requirementisimposedby35U.S.C.§112,
first paragraph, which states:
The specification shall contain a written description of the
invention, and of the manner and process of making and
using it, in such full, clear, concise, and exact terms as to
enable any person skilled in the art to which it pertains, or
with which it is most nearly connected, to make and use the
same[.]15
In 1991, the Federal Circuit’s test for written description became what may
be termed the “possession” test.16
Compliance turned on “[w]hether the
disclosure of the application . . . reasonably conveys to the skilled artisan
6. 238 AIPLA Q.J. Vol. 30:233
17
Id.
18
35 U.S.C. § 103 (2000).
19
SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1355,
55 U.S.P.Q.2d (BNA) 1927, 1930-31 (Fed. Cir. 2000)(citing Graham v.
John Deere Co., 383 U.S. 1, 17-18, 118 U.S.P.Q. (BNA) 459, 466-67
(1966)).
20
Id.
that the inventor had possession . . . of the later claimed subject matter.”17
The “non-obviousness” requirement derives from 35 U.S.C. § 103, which
states:
A patent may not be obtained . . . if the differences between
the subject matter sought to be patented and the prior art are
such that the subject matter as a whole would have been
obvious at the time the invention was made to a person
having ordinary skill in the art to which said subject matter
pertains.18
Deciding the issue of obviousness requires an inquiry into the scope
and content of the prior art, the level of ordinary skill in the field of the
invention, the differences between the claimed invention and the prior art,
and any objective evidence of non-obviousness, such as long-felt need and
commercial success.19
The Federal Circuit has also required that there be a
suggestion or motivation to modify the prior art in such a way as to arrive
at the claimed invention; the suggestion or motivation may be derived from
the prior art reference itself, from the knowledge of one of ordinary skill in
the art, or from the nature of the problem to be solved.20
7. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 239
21
Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 U.S.P.Q.2d (BNA)
1016 (Fed. Cir. 1991).
22
Fiers v. Revel, 984 F.2d 1164, 25 U.S.P.Q.2d (BNA) 1601 (Fed. Cir. 1993).
23
In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d (BNA) 1210 (Fed. Cir. 1995).
24
Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 43
U.S.P.Q.2d (BNA) 1398 (Fed. Cir. 1997).
25
Amgen, 927 F.2d at 1205, 18 U.S.P.Q.2d (BNA) at 1020.
26
Id. at 1206, 18 U.S.P.Q.2d (BNA) at 1021.
27
Id.
III. WRITTEN DESCRIPTION AND OBVIOUSNESS AT THE FEDERAL CIRCUIT
Recent cases have raised the question of whether the Federal Circuit
has imposed new substantive criteria regarding written description for
genetic inventions. Those recent cases include the following: Amgen, Inc. v.
Chugai Pharmaceutical Co. (1991),21
Fiers v. Revel (1993),22
In re Deuel (1995),23
and Regents of the University of California v. Eli Lilly & Co. (1997).24
In Amgen, a scientist claimed priority to a purified and isolated gene
based on his allegation that he conceived how to identify and isolate the
gene before the patentee.25
The Federal Circuit held that the conceived
method for identifying and isolating the gene was not conception of the
“purified and isolated DNA sequence” that had been claimed by the
patentee.26
Because the patentee was first to actually isolate the gene, he was
deemed the first to conceive it and was entitled to priority of invention.27
The patentee’s disclosure of the DNA sequence of the isolated gene was
8. 240 AIPLA Q.J. Vol. 30:233
28
Id.; see, e.g., Fiers v. Revel, 984 F.2d 1164, 1171, 25 U.S.P.Q.2d (BNA)
1601, 1606 (Fed. Cir. 1993); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555,
1555, 19 U.S.P.Q.2d (BNA) 1111, 1111 (Fed. Cir. 1991).
29
Fiers, 984 F.2d at 1166, 25 U.S.P.Q.2d at 1602.
30
Id. at 1167, 25 U.S.P.Q.2d (BNA) at 1603.
31
Id.
32
Id. at 1169, 25 U.S.P.Q.2d (BNA) at 1605.
33
Id.
34
Id.
sufficient to demonstrate that he had possession of the invention and, by
implication, also satisfied the written description requirement.28
Fiers was an appeal from a three-way interference action in the PTO
to resolve conflicting claims to priority of invention between Fiers, Revel,
and Sugano.29
Sugano was the first to file a U.S. patent application; his
application covered a gene that coded for beta interferon ($-IF).30
Fiers
argued that he previously conceived a method for preparing the DNA,
which entitled him to claim the DNA itself, per se, without requiring him to
specifically claim the process for preparing it.31
The Federal Circuit rejected
Fiers’ position, explaining that “[c]onception of a substance claimed per se
without reference to a process requires conception of its structure, name,
formula, or definitive chemical or physical properties.”32
Fiers could not
claim the substance per se; he was only entitled to a product-by-process
claim limited to the particular method for making it.33
The Federal Circuit
further explained that conception of the substance per se required the ability
to “describe” the substance itself, with particularity as required by the
statute.34
9. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 241
35
Id.
36
Id. at 1170-71, 25 U.S.P.Q.2d (BNA) at 1606.
37
Id. at 1171, 25 U.S.P.Q.2d (BNA) at 1606.
38
In re Deuel, 51 F.3d 1552, 1553-54, 34 U.S.P.Q.2d (BNA) 1210, 1211 (Fed.
Cir. 1995).
39
Id. at 1556, 34 U.S.P.Q.2d at 1213.
The Federal Circuit expanded on this reasoning in rejecting Revel’s
argument for priority based upon his previously proposed method for
isolatingtheDNA,asdescribedin a foreign counterpartpatentapplication.35
The Court stated:
An adequate written description of a DNA requires more
than a mere statement that it is part of the invention and
reference to a potential method for isolating it; what is
required is a description of the DNA itself. . . . A bare
reference to DNA with a statement that it can be obtained by
reverse transcription is not a description; it does not indicate
that Revel was in possession of the DNA.36
The Federal Circuit further explained: “If a conception of DNA requires a
precise definition, such as by structure, formula, chemical name, or physical
properties, as we have held, then a description also requires that degree of
specificity.”37
In Deuel, a patent applicant appealed from a determination by the
PTO Board of Patent Appeals and Interferences (“BPAI”) that claims to
cDNA molecules encoding heparin-binding growth factors were invalid for
obviousness.38
The PTO rejected the relevant claims over the combined
teachings of two references.39
The first reference taught the partial N-
terminal amino acid sequence of several such growth factors, but did not
disclose the polynucleotide sequence of any cDNAs that encode these
10. 242 AIPLA Q.J. Vol. 30:233
40
Id.
41
Id.
42
Id.
43
Id. at 1558, 34 U.S.P.Q.2d (BNA) at 1215.
44
There are twenty possible amino acids, compared to sixty-four possible
three-base ordered triplets (“codons”). Consequently, certain amino
acids are encoded by more than one codon. This disparity is the so-
called “degeneracy” of the genetic code. Due to degeneracy, a very
large number of distinct possible cDNA sequences can encode a
specified amino acid sequence (or polypeptide). However, a specified
cDNA sequence encodes only a single particular amino acid sequence.
45
In re Deuel, 51 F.3d 1552, 1558, 34 U.S.P.Q.2d (BNA) 1210, 1215 (Fed.
Cir. 1995).
growth factors.40
The second reference was a manual of techniques that
explained in general terms how to isolate cDNAs by screening a library of
cDNAs with a radioactive probe.41
The obviousness rejection was based,
inter alia, upon the reasoning that a person of ordinary skill in the art could
havedesignedageneprobebasedupontheN-terminalaminoacidsequence
disclosed in the first reference and then obtained cDNAs encoding the
growthfactorsusingthestandardmethodstaughtbythesecondreference.42
Nevertheless, the Federal Circuit held that the cited combination of
references failed to render the claims obvious.43
The Federal Circuit
reasonedthatthedegeneracy44
ofthegeneticcode“precludedcontemplation
of or focus on the specific cDNA molecules” of the claims, and that “one
could not have conceived the subject matter of [the relevant claims] based
on the teachings in the cited prior art because, until the claimed molecules
were actually isolated and purified, it would have been highly unlikely for
one of ordinary skill in the art to contemplate what was ultimately
obtained.”45
The Federal Circuit concluded that “[w]hat cannot be
11. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 243
46
Id.
47
In re Bell, 991 F.2d 781, 784, 26 U.S.P.Q.2d (BNA) 1529, 1531 (Fed. Cir.
1993).
48
Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566-69,
43 U.S.P.Q.2d (BNA) 1398, 1404-05 (Fed. Cir. 1997).
49
Id. at 1568, 43 U.S.P.Q.2d (BNA) at 1405.
50
Id.
contemplated or conceived cannot be obvious.”46
The Federal Circuit relied
upon its earlier holding in In re Bell, which explicitly rejected the proposition
that “the established relationship in the genetic code between a nucleic acid
and the protein it encodes also makes a gene prima facie obvious over its
correspondent [sic] protein.”47
In Lilly, the Federal Circuit affirmed a district court’s judgment of
invalidity due to inadequate written description where the patentee had
broadly claimed cDNA that codes for the hormone insulin, while only
disclosing the relevant cDNA sequence of rat insulin.48
Because the claims
were broadly directed to vertebrate, mammalian, and human cDNA, the
FederalCircuitaffirmedthefindingofinadequatewrittendescription.49
The
Federal Circuit stated that a written description of the relevant human
cDNA, including its structure, is necessary for a claim that would cover
human insulin cDNA.50
While the example provides a process for obtaining human
insulin-encoding cDNA, there is no further information in
the patent pertaining to that cDNA’s relevant structural or
physical characteristics; in other words, it thus does not
describe human insulin cDNA. Describing a method of
preparing a cDNA or even describing the protein that the
cDNA encodes, as the example does, does not necessarily
describe the cDNA itself. No sequence information
12. 244 AIPLA Q.J. Vol. 30:233
51
Id. at 1567, 43 U.S.P.Q.2d (BNA) at 1405.
52
Id. at 1569, 43 U.S.P.Q.2d (BNA) at 1406.
indicating which nucleotides constitute human cDNA
appears in the patent, as appears for rat cDNA. . . .
Accordingly, the specification does not provide a written
description of the invention[.]51
The Federal Circuit explained that, for the same reasons, the specification
also contained inadequate written description to support genus claims
covering cDNA of vertebrates or mammals, which otherwise could have
been supported by describing the sequence of a representative number of
cDNAs falling within the scope of the genus, or by describing structural
features common to the genus.52
IV. IMPETUS FOR ATTENTION AT THE PTO
Parallel to the developments at the Federal Circuit, there has been
public debate among interested parties about the appropriate patentability
criteria for genetic inventions. In general, there has been support for criteria
that would prevent the patenting of broad claims based upon partial DNA
sequences and, in particular, those partial sequences for which no specific
biological utility has been demonstrated. In 1991, the American Society of
13. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 245
53
The ASHG represents professionals and students in the field of human
genetics. Members are involved in various areas of genetic research
and related health care services and in the study of the human genome.
ASHG’s website is located at http://www.ashg.org.
54
See Letter from Human Genome Committee and Board of Directors,
American Society of Human Genetics, to the Editor, 254 SCIENCE 1711-
12 (1991)[hereinafter American Society of Human Genetics].
55
ESTs are determined from the products of gene transcription. During
cellular transcription, gene segments of nuclear DNA are copied into
messengerRNAs(“mRNAs”). Scientistsreverse-transcribe the mRNAs
to provide complementary DNAs (“cDNAs”), parts of which are
sequenced to provide ESTs. Thus, ESTs may complement protein-
encoding parts of expressed genes, i.e., “protein-encoding” portions of
the nuclear DNA.
Human Genetics53
(“ASHG”) published a position paper that expressed this
view.54
The issue of expressed sequence tags (“ESTs”), however, has
engendered some controversy. ESTs are partial cDNA sequences of
expressed genes.55
Databases of ESTs permit scientists to search any
catalogued species for genes or gene clones having ESTs similar to a gene of
interest. Such similarity usually corresponds to a similarity in the proteins
encoded by the genes and the functions of those proteins. In addition to
uses for tagging or probing, scientists can combine information from related
ESTs to catalogue the members of a related gene family.
It has been argued that identification of an EST, without more, lacks
utility and provides inadequate written description for a functional gene.
The argument that ESTs may not have “utility” arises from the fact that
various ESTs may not have any coding function themselves, nor provide an
easy means to determine either the sequence or the function of the full
length gene from which the ESTs were derived. In fact, the majority of EST
sequences in the public database have no definitively assigned function.
14. 246 AIPLA Q.J. Vol. 30:233
56
One source of debate was a set of patent applications filed in the name
of Craig Ventner et al. and assigned to the National Institutes of Health
(“NIH”). See U.S. Patent Application 07/716,831 (filed June 21, 1991);
U.S. Patent Application 07/837,195 (filed Sept. 25, 1992); U.S. Patent
Application 07/952,911 (filed Feb. 12, 1993). These applications were
criticized as lacking utility. In the wake of the criticism, NIH
abandoned the applications and expressed its intention of not filing
similar applications in the future. However, NIH continues to play a
central role in the debate by actively expressing its views about the
broader public policy of patenting genetic inventions.
This is why questions have been raised about whether an EST itself can meet
the “utility” requirement of U.S. patent law.
The argument that identifying an EST may not satisfy the “written
description” requirement for a claim to an entire functional gene is based on
the fact that a single EST may correspond to a number of functionally
distinct cDNAs. Thus, a claim to any cDNA that “comprises” the sequence
of a particular EST might read on a multiplicity of structurally and
functionally distinct cDNA species, none of which have been separately
identified and described. Also, a single gene can express multiple cDNAs,
and some genes have partial sequences in common with other genes.
Consequently, multiple genes will often have some ESTs in common. It is
therefore argued that a full written description of a functional gene must
disclose more than just ESTs.
This argument has been raised in connection with the Human
Genome Project—the most visible genetic endeavor of international
concern.56
The ASHG has stated:
An international collaborative venture as bold as the Human
Genome Project should not be jeopardized by the possibility
of irrevocable damage inflicted by EST patents. . . . Let us
strive to ensure that patents are obtainable . . . that [they] will
still allow commercial exploitation of genetic information,
15. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 247
57
See American Society of Human Genetics, supra note 54, at 1711.
58
The Human Genome Organization, HUGO Statement on Patenting of
DNA Sequences: In Particular Response to the European Biotechnology
Directive (April 2000), at http://www.hugo-international.org/hugo/
patent2000.html.
59
See also Letter from Herbert Curien, French Minister for Research and
Technology, to Editor, 254 SCIENCE 1 (1991).
60
ASSINSEL, What is ASSINSEL?, at http://www.worldseed.org/
what_asse.htm (last modified Apr. 12, 2001).
61
ANNINSEL, Development of New Plant Varieties and Protection of
Intellectual Property (June 1999), at http://www.worldseed.org/
IPprotectione.htm (other position papers adopted by ANNINSEL
members can be located at http://www.worldseed.org/positions.html).
but not so early in the process that it will stifle individual
scientific endeavor and lead to international chaos.57
Similarly, the Human Genome Organization (“HUGO”) issued a statement
expressing “serious concerns about the negative impact on further progress
of genomic research and successful exploitation of its results should broad
claims of the so-called ‘having’ and ‘comprising’ type be issued for ESTs.”58
In addition to human genetics,59
concern about plant genetics has
been raised by the International Association of Plant Breeders for the
Protection of Plant Varieties (“ASSINEL”), an international organization of
crop producers.60
ASSINEL has recently issued a statement that partial
DNA sequences such as ESTs should not be patentable,61
in contrast to
genetic components that are known to express a characteristic or trait (for
example, in crops). This position was based upon a survey in 1998 of
ASSINSEL’s members in twenty-nine industrialized and developing
16. 248 AIPLA Q.J. Vol. 30:233
62
Id.
63
Id.
64
Requestfor Commentson Interim GuidelinesforExaminationofPatent
Applications Under the 35 U.S.C. § 112, ¶ 1, “Written Description”
Requirement, 63 Fed. Reg. 32,639 (June 15, 1998).
65
Revised Interim Guidelines for Examination of Patent Applications
Under the 35 U.S.C. § 112, ¶ 1, “Written Description” Requirement,
Request for Comments, 64 Fed. Reg. 71,427 (Dec. 21, 1999)[hereinafter
Revised Interim Written Description Guidelines].
countries.62
The countries included Argentina, Australia, Austria, Belgium,
Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France,
Germany, Netherlands, India, Ireland, Israel, Italy, Japan, Kenya, Norway,
New Zealand, Poland, Slovakia, South Africa, Sweden, Switzerland, the
United Kingdom, and the United States.63
V. WRITTEN DESCRIPTION GUIDELINES
In response to the evolution in written description criteria occurring
at the Federal Circuit, the PTO formulated Interim Written Description
Guidelines, which were published along with a request for public comment
on June 15, 1998.64
The PTO received a number of comments advocating an
expansion of the PTO’s efforts and urging that the biotechnology-specific
guidelines be made generally applicable. The PTO attempted to implement
these suggestions in its Revised Interim Guidelines for Examination of
Patent Applications Under the 35 U.S.C. § 112, ¶ 1, “Written Description”
Requirement, issued on December 21, 1999.65
After another round of
comments were collected, the PTO issued its final Guidelines for
Examination of Patent Applications Under the 35 U.S.C. § 112, ¶ 1, “Written
17. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 249
66
See Written Description Guidelines, supra note 2, at 1099.
67
Id. at 1104.
68
Id. at 1105.
69
Id.
70
Id.
71
Id.
72
Id.
Description” Requirement (“Written Description Guidelines”) on January
5, 2001.66
Beginning with general principles, the Written Description
Guidelines set forth a methodology for determining whether patent claims
are supported by an adequate written description.67
The first steps include
reading the specification and construing the claims.68
The claims are
accorded their broadest reasonable interpretation consistent with the
specification, and the weight to be accorded the preamble is evaluated.69
The entire application is considered in determining what the applicant has
described as the “essential features” of the invention.70
The examiner must then consider whether the written description is
sufficient to inform a person of ordinary skill in the art that the applicant
was in possession of the claimed invention at the time the application was
filed.71
The examiner has the initial burden of presenting evidence or
reasons why the written description is inadequate for such purpose, in light
of a strong presumption of adequacy.72
18. 250 AIPLA Q.J. Vol. 30:233
73
Id.
74
Id.
75
Id. at 1106.
76
Id.
77
Id.
78
Id.
79
Id.
The written description may indicate possession of the claimed
invention in any number of ways.73
The description may provide details of
an actual reduction to practice, clearly depict the invention in detailed
drawings, or provide identifying characteristics.74
For single embodiment
or species claims, the examiner must search the description for identifying
characteristicsthatdistinguishthe claimed inventionfromothermaterials.75
For genus claims, the examiner must look for a representative
number of species.76
Although individual support for each species covered
by the genus claim is unnecessary, a sufficient variety should be described
when there is substantial variation within the genus.77
The description
should provide adequate evidence of the attributes common to members of
the genus, in view of the species disclosed.78
Throughout the Written Description Guidelines, the most-
emphasized point is that the written description must be sufficient to lead
a skilled artisan to clearly recognize the applicant’s possession of the
claimed invention.79
Any claim that fails to meet this requirement is to be
19. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 251
80
Id.
81
The training materials are not published in the Federal Register, but
currently may be downloaded from the PTO’s website. See PTO,
Revised Interim Written DescriptionGuidelines Training Materials, available
at http://www.uspto.gov/web/offices/pac/writtendesc.pdf.
rejected under section 112, paragraph 1, as lacking support in the written
description.80
The PTO seems to have accomplished its goal of generalizing the
new Written Description Guidelines. There are few provisions in the body
of the Written Description Guidelines that are biotechnology-specific and
none relating to problems raised by partial DNA sequences or ESTs.
WhiletheWrittenDescriptionGuidelinesthemselvesarecouchedin
general terms that apply to all of the arts, the PTO has provided
biotechnology-specific guidance in its responses to comments, its Written
Description Guidelines’ footnotes, and its internal training materials, which
contain an entire section replete with biotechnology examples.81
In one
interesting footnote to the Written Description Guidelines, the PTO
addresses a generic claim to any DNA that encodes a particular amino acid
sequence:
For example, in the molecular biology arts, if an applicant
disclosed an amino acid sequence, it would be unnecessary
to provide an explicit disclosure of nucleic acid sequences
that encoded the amino acid sequence. Since the genetic
code is widely known, a disclosure of an amino acid
sequence would provide sufficient information that one
would accept that an applicant was in possession of the full
genusofnucleicacidsencodingagivenaminoacidsequence,
but not necessarily any particular species. Cf. In re Bell, 991
F.2d 781, 785, 26 U.S.P.Q.2d 1529, 1532 (Fed. Cir. 1993) and In
20. 252 AIPLA Q.J. Vol. 30:233
82
Written Description Guidelines, supra note 2, at 1111 n.57.
83
See supra Part III.
84
See Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1567,
43 U.S.P.Q.2d (BNA) 1398, 1405 (Fed. Cir. 1997).
85
The Federal Circuit has acknowledged in dictum a very narrow
circumstance under which a disclosed amino acid sequence might
render obvious claims to each of the possible DNA moleculesthatcould
encode that amino acid sequence. In re Deuel, 51 F.3d 1552, 1559, 34
U.S.P.Q.2d (BNA) 1210, 1215 (Fed. Cir. 1995). The Federal Circuit
asserted that, given “a protein of sufficiently small size and simplicity”,
each DNA molecule that encodes that protein might be obvious over
the protein. Id. (citing In re Petering, 301 F.2d 676, 682-83, 133 U.S.P.Q.
(BNA) 275, 280-81 (C.C.P.A. 1962)(holding that prior art reference
disclosing limited genus of twenty compounds rendered every species
within the genus unpatentable)). Because on average each amino acid
re Baird, 16 F.3d 380, 382, 29 U.S.P.Q.2d 1550, 1552 (Fed. Cir.
1994).82
This footnote is interesting when viewed in light of Federal Circuit
precedent embodied in In re Bell, In re Baird, and In re Deuel.83
The Federal
Circuit interpreted those cases as indicating that, for a disclosure to satisfy
the written description requirement, it must provide enough information to
have also rendered the claim obvious had the disclosure been contained in
a prior art reference.84
Under the PTO’s Written Description Guidelines,
disclosure of an amino acid sequence satisfies the written description
requirement for a claim to the full genus of nucleic acids encoding the amino
acid. In light of Bell, Baird, and Deuel, this would mean that a prior art
reference disclosing an amino acid sequence must necessarily provide
enoughinformationtorenderobvious thesameclaimtothegenusofnucleic
acids encoding the amino acid sequence. However, the Federal Circuit
stated that this is not the case. In Deuel, the Federal Circuit stated that
disclosing an amino acid sequence does not render obvious a claim to the
genus of nucleic acids encoding the amino acid sequence.85
21. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 253
of a protein can be encoded by any of three distinct codons, even a
protein consisting of only ten randomly-selected amino acids could be
encoded by almost 60,000 distinct DNA sequences, and thus would not
likely be “of sufficiently small size and simplicity” to satisfy the court’s
dictum. Id. at 1559, 34 U.S.P.Q.2d (BNA) at 1215.
86
See PTO, RevisedInterimWrittenDescriptionGuidelinesTrainingMaterials,
at 30, available at http://www.uspto.gov/web/offices/pac/
writtendesc.pdf.
87
Id. at 32.
One way to reconcile Federal Circuit precedent with the PTO’s
position is to note that the relevant Federal Circuit cases dealt with patent
applications filed early in the history of molecular biology. At that time,
cloning a cDNA which encodes a known amino acid sequence was far from
routine. The PTO’s Written Description Guidelines, on the other hand, are
intended to apply to more recently filed applications and those filed in the
future, when cloning cDNA based upon a partial amino acid sequence is
indeed routine. A search of the PTO database reveals a large number of
issued patents that contain generic claims to cDNA molecules limited only
by the encoded amino acid sequence. It remains to be seen, of course, how
the Federal Circuit will apply its earlier precedent to PTO patentability
determinations that embody the new Written Description Guidelines in this
respect.
One example in the PTO’s training materials addresses ESTs. In
“Example 7: EST,” the PTO indicates that the disclosure of a partial DNA
sequence corresponding to an EST is insufficient written description to
support a claim to “[a]n isolated DNA comprising [the partial sequence].”86
In support of its conclusion, the PTO notes that only a single common
structural feature—the partial sequence—is shared by members of the
claimed “isolated DNA” genus.87
It further observes that the genus
22. 254 AIPLA Q.J. Vol. 30:233
88
Id.
89
Id.
90
Id.
91
Id.
92
See id. at 50.
93
Id.
94
Id.
95
Id. at 52.
encompasses genes yet to be discovered.88
Finally, it notes that the partial
sequence does not “constitute a substantial portion” of the claimed genus.89
In view of the partial structure, the breadth of the claim (including genes yet
to be discovered), and a lack of correlation to genetic function, the PTO
concludes that one skilled in the art would not recognize the applicant to
have been in possession of the genus of DNAs which comprise the partial
sequence.90
Consequently, the PTO would reject the claim under 35 U.S.C.
§ 112, ¶ 1, as unsupported by sufficient written description.91
Another interesting example in the written description training
materials is “Example 13: Protein Variant.”92
In this example, a protein has
been isolated from liver, and its exact amino acid sequence is disclosed in
the specification.93
The specification also states that the invention provides
“variants” of the disclosed sequence, “having one or more amino acid
substitutions, deletions, insertions, and/or additions,” but provides no
further description of the variants.94
The examiner is instructed in this case
to reject the claim for failure to satisfy the written description requirement
“because a representative number of species have not been described.”95
23. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 255
96
See id. at 27-59.
Other specific examples in the training materials are: genes, a DNA
fragment encoding a full length open reading frame (ORF, a putative
protein-coding region), hybridization, a process claim, an allelic variant,
bioinformatics, a product by function, antisense, and antibodies.96
While not directly addressed in any of the PTO’s published
materials, a related and important question arises in the context of nearly
identical or similar genes from closely related strains or species. The
proteins encoded by such genes may differ from one another by as few as
one amino acid. If a gene from a particular strain of Escherichia coli (“E.
coli”) bacteria encoding protein “X” is isolated, sequenced, and disclosed,
should that disclosure be sufficient written description to support a claim to
DNA molecules encoding the related protein from all strains of E. coli?
From E. coli and other Gram negative bacteria? From all bacteria? If one
takes guidance from the Federal Circuit, it would appear, mutatis mutandis,
that there is only support for claims to protein “X” from the particular strain
disclosed, as one could not conceive the particular amino acid sequence of
any related protein other than the particular one whose gene was sequenced
and disclosed.
On the other hand, if one takes seriously the PTO’s suggestion that
a disclosed amino acid sequence satisfies the written description
requirement with regard to a generic claim to any DNA molecule that
encodes that amino acid sequence, then one might argue that it is nearly as
predictable and routine in the art to obtain the analogous gene from a
closely related species as it is to isolate a cDNA corresponding to a particular
amino acid sequence. The PTO has not yet directly addressed this
argument, but there is anecdotal information to consider. Specifically, the
file histories of several issued patents reveal that at least some PTO
examiners do not consider published sequences of a protein “X” from one
bacterial strain to render obvious claims to protein “X” from another strain
of the same bacterial species—so long as they differ by at least a single
amino acid. One could therefore arguethat,underDeuel and related Federal
Circuit precedent, genus claims to protein “X” in strains other than the
24. 256 AIPLA Q.J. Vol. 30:233
97
Of course, Deuel and related Federal Circuit precedent have not
prevented the PTO from drawing its own conclusions on other related
issues(e.g., concludingthatanaminoacidsequencesatisfiesthewritten
description requirement for a claim to the full genus of nucleic acids).
98
See Request for Comments on Interim Guidelines for Examination of
Patent Applications Under the 35 U.S.C. § 112, ¶ 1, “Written
Description” Requirement, 63 Fed. Reg. 32,639, 32,639 (June 15,
1998)(“These ‘Written Description Guidelines’ are intended to assist
Office personnel . . . in view of” Lilly, Fiers and Amgen.)
99
Utility Examination Guidelines, 60 Fed. Reg. 36,263 (July 14, 1995).
100
“The Revised Interim Guidelines [for written description] are not the
appropriate vehicle to fully address the patentability of ESTs. In view
of comments and testimony with respect to ESTs and the enablement
and utility requirements, the PTO is revising the Utility Guidelines as
presented at 60 Fed. Reg. 36,263 (July 14, 1995).” Revised Interim
Written Description Guidelines, supra note 65, at 71,427.
particularstrainfromwhichtheprotein“X”genewasclonedandsequenced
must be rejected for failure to satisfy the written description requirement.97
VI. UTILITY GUIDELINES
The comments to the Interim Written Description Guidelines,
published on June 15, 1998,98
also suggested to the PTO that its Utility
Examination Guidelines99
needed revision or clarification.100
Some
comments suggested that the utility of an EST is not established when its
corresponding gene is unknown, and the sole disclosed use of the EST is to
identifyothergeneticmaterialofunknown utilityandfunction(i.e.,function
25. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 257
101
See Revised Interim Written Description Guidelines, supra note 65, at
71,433.
102
RevisedUtilityExaminationGuidelines:RequestforComments,64Fed.
Reg. 71,440, 71,440-41 (Dec. 21, 1999).
103
Id. at 71,440.
104
Utility Guidelines, supra note 2, at 1092.
105
Id. at 1094.
106
Id. at 1093.
107
See id. at 1098.
as a “probe”).101
Even if an EST is sufficiently described as a DNA sequence,
it might not be useful for specific mapping of a gene or tissue typing.
According to the PTO, the general concern was that patents would be
grantedfor“nonspecificandnonsubstantialutilities,contrarytoestablished
case law.”102
On December 21, 1999, the PTO issued Revised Utility Examination
Guidelines with a Request for Comments.103
After these comments were
collected, the PTO issued its final Utility Examination Guidelines.104
According to the Utility Examination Guidelines, if an invention has a well-
established utility that would be known to one of ordinary skill in the art, an
examiner should not issue a rejection for lack of utility.105
A rejection also is
inappropriate if the applicant asserts that an invention has a specific
practical purpose—a “specific and substantial” utility—that would be
credible to a person of ordinary skill in the art.106
Credibility in such a
circumstance is assessed in view of the disclosure along with any other
evidence of record, such as test data, statements of experts, patents, or
printed publications.107
26. 258 AIPLA Q.J. Vol. 30:233
108
See id. at 1093.
109
See id. at 1095.
110
See id. at 1097.
111
Id.
112
See id. at 1098.
113
Id. at 1097.
114
PTO, Revised Interim Utility Guidelines Training Materials, available at
http://www.uspto.gov/web/offices/pac/utility/utilityguide.pdf.
Absentawell-establishedutilityorcredibleassertionof“specificand
substantial” utility, the examiner is to reject the claim(s) for lack of utility
under 35 U.S.C. § 101.108
The examiner is also instructed to impose a
rejection under 35 U.S.C. § 112, ¶ 1, for lack of written description of how to
use the invention for any such utility.109
This shifts to the applicant the burden of coming forward with
evidence to overcome the rejection.110
The applicant may meet its burden by
explicitly identifying a “specific and substantial” utility and providing
evidence that a person of ordinary skill in the art would have recognized
that such utility was well established at the time of filing.111
Appropriate
evidence of utility again includes test data, statements of experts, etc.112
The
examiner is then required to verify an adequate nexus between the
evidentiary showing and the application as filed.113
Like the Written Description Guidelines, the Utility Guidelines are
couched in general terms, but the PTO has similarly provided training
materials with a number of biotechnology examples.114
“Example 9: DNA
Fragments” refers to a patent application that discloses fragmentary DNA
27. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 259
115
Id. at 50-53.
116
See id. at 50.
117
See id. at 50-53.
118
Id. at 52-53.
119
Id. at 50.
120
See id. at 51.
121
See id.
122
See id. at 51-52. The elements of “specific, substantial and credible”
utility in the first step are clearly stated in “Example 10: DNA Fragment
encoding a Full Open Reading Frame (DRF)” as follows: “In order to
determine whether the claimed invention has a well-established utility
the examiner must determine that the invention has a specific,
substantial and credible utility that would have been readily apparent
to one of skill in the art.” See id. at 55. Similarly, the definition section
in the training materials states: “‘Well established utility’ does not
sequences of a gene and how to use the sequences to probe for the gene.115
The gene can be used to make proteins, possibly for further study.116
Although some of the fragment sequences are long enough to encode
functional proteins, no specific examples are disclosed.117
In view of this
disclosure, the PTO would find a lack of utility in a claim covering “[a]
cDNA consisting of the [fragment sequence].”118
Patentable utility can be established by satisfying one of two
inquiries.119
First, the PTO inquires whether there is a “well-established
utility,” i.e., one that is well-known in the art, or immediately apparent
upon reading the specification.120
Second, the PTO inquires whether the
applicant has asserted a “specific and substantial” utility.121
In practice,
however, both inquiries require the examiner to find a utility that is specific,
substantial, and credible.122
28. 260 AIPLA Q.J. Vol. 30:233
encompass any ‘throw away’ utility that one can dream up for an
invention [i.e., insubstantial utility] or a nonspecific utility that would
apply to virtually every member of a general class of materials, such as
proteins or DNA.” See id. at 7.
123
Id. at 51.
124
Id. at 51-52.
125
Id. at 53.
126
See id. at 52.
According to the PTO, the asserted utility of the DNA fragment as
a probe is not “specific” because that asserted utility would apply to the
general class of all cDNAs and does not distinguish the claimed cDNA from
any other.123
The utility for making a protein is not deemed “substantial”
because the protein is considered useful only for identifying and studying
the protein’s own properties or mechanisms, which “does not define a ‘real
world’ context of use.”124
The PTO therefore concludes from the first inquiry that there is no
“well-established utility” for the sequence and concludes from the second
inquiry that there is no asserted “specific and substantial” utility.125
Thus,
the DNA sequence does not satisfy either inquiry for the sole reason that the
PTO considers the utility of the sequence to be insubstantial and
nonspecific.126
Because the two inquiries for establishing utility each require
specific, substantial, and credible utility, it is useful to consider when the
two inquiries will differ in result. It appears that this will occur in two
situations. The first situation is when the specific and substantial utility is
readily apparent to one of skill in the art, but is not asserted, i.e., it would be
“well-established” (first inquiry), but not asserted to be “specific and
substantial” (second inquiry). The second situation is when the specific and
substantial utility is asserted, but is not readily apparent to one of skill in the
29. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 261
art, i.e., it would be “specific and substantial” (second inquiry), but not
“well-established” (first inquiry).
The Utility Guidelines suggest that the PTO does not intend to grant
patents “too early” in the gene-based discovery pipeline. The first person
to clone a fragment of a gene or cDNA must “assert” a utility that
demonstrates an understanding of the specific role of the gene or encoded
proteinincellularororganismicfunction. Otherwise,theabsenceofa“well-
established” utility will prevent the person from obtaining patent claims
covering DNA or protein molecules “comprising” that polynucleotide or
polypeptide fragment. Thus, under the PTO’s understanding of the
“specific and substantial utility” requirement, patent claims will only be
granted to the first person who demonstrates some understanding of the
function of the gene or encoded protein. It remains to be seen to what extent
the PTO will consider DNA and amino acid sequence homology to
sequences of known function as evidence of specific and substantial utility
and what degree of homology might be required.
30. 262 AIPLA Q.J. Vol. 30:233
127
The PTO made the comments to the new guidelines available for public
inspection at the PTO by April 19, 2000. In addition to hard copy
comments available at Suite 918, Crystal Park 2, 2121 Crystal Drive,
Arlington, Virginia, comments provided in machine readable format
are currently available through the PTO’s website available at
http://www.uspto.gov/web/offices/com/speeches/00-25.htm. In
addition to NIH, comments were submitted by, inter alia, the American
Intellectual Property Law Association and the Biotechnology Industry
Organization. See PTO, Public Comments on the United States Patent and
TrademarkOffice"RevisedInterimUtilityExaminationGuidelines,”available
at http://www.uspto.gov/web/offices/com/sol/comments/utilguide/
index.html; PTO, Public Comments on the United States Patent and
Trademark Office "Revised Interim Guidelines for Examination of Patent
Applications Under the 35 U.S.C. § 112, ¶ 1 ‘Written Description’
Requirement," available at http://www.uspto.gov/web/offices/com
sol/comments/utilitywd/index.html.
128
See Letter from Harold E. Varmus, Director of the National Institutes of
Health, and Francis S. Collins,Director of the National Human Genome
ResearchInstitute,toTheHonorableQ.ToddDickinson,Commissioner
of the PTO (Dec. 21, 1999)(on file with authors)[hereinafter Varmus &
Collins]; Letter from Jack Spiegel, Director of the Division of
Technology Transfer & Development, Office of Technology Transfer,
National Institutes of Health, to The Honorable Q. Todd Dickinson,
Commissioner of the PTO (Dec. 21, 1999)(on file with
authors)[hereinafter Spiegel].
129
See Varmus & Collins, supra note 128; Spiegel, supra note 128.
VII. NIH’S VIEW OF THE NEW GUIDELINES
127
Prior to submitting comments, the National Institutes of Health
(NIH) sent two letters to the PTO.128
In the letters, NIH strongly supported
the requirement that a claimed invention possess a specific, substantial, and
credible utility.129
NIHexpressed concern, however, that an examiner might
find a bold assertion of theoretical function sufficient to meet the utility
31. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 263
130
See Varmus & Collins, supra note 128; Spiegel, supra note 128.
131
See Varmus & Collins, supra note 128; Spiegel, supra note 128.
132
See Varmus & Collins, supra note 128; Spiegel, supra note 128.
133
See Letter from The Honorable Q. Todd Dickinson, Commissioner of
the PTO, to Harold E. Varmus, Director of the National Institutes of
Health, and Francis Collins, Director of the National Human Genome
Research Institute (Jan. 7, 2000)(on file with authors). By January 7,
2000, Dr. Harold E. Varmus had left the NIH. He is currently the
President and Chief Executive Officer of the Memorial Sloan-Kettering
Cancer Center in New York City.
134
See id.
135
See id.
requirement.130
Such a boldassertion couldbemade,itsuggested,regarding
an encoded protein that theoretically might be expected, based upon
homology, to be useful as a kinase, helicase, zinc finger, or other known
functional class of protein.131
NIH also expressed concern that the PTO’s
willingness to grant open-ended “comprising claims” for partial sequences
might result in overly broad patents unsupported by sufficient disclosure.132
The Commissioner of the PTO responded to NIH by emphasizing
that patent applications would be examined on a case-by-case basis using
general principles.133
The Commissioner acknowledged, however, that a
protein’s mere membership in a family might not warrant an inference of
utility, for example, if individual members require specific activation.134
In
particular, a failure to describe how to activate the protein could lead to
utility or enablement problems, depending on the facts.135
With regard to
“comprising claims,” the Commissioner assured NIH that the PTO would
32. 264 AIPLA Q.J. Vol. 30:233
136
See id.
137
Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1571,
24 U.S.P.Q.2d (BNA) 1401, 1412 (Fed. Cir. 1992)
138
In a recent decision, the Federal Circuit, while considering the question
“interesting,” declined to address whether a patent specification’s
disclosure of a sequence of 191 amino acids was sufficient to enable a
claim covering all possible DNA sequences that encode that amino acid
sequence. See Bio-Technology Gen. Corp. v. Genentech, Inc., 267 F.3d
1325, 1333, 60 U.S.P.Q.2d 1430, 1436 (Fed. Cir. 2001).
follow the recent cases of the Federal Circuit, such as Lilly, which set forth
criteria for the written description requirement, as described above.136
VIII. FUTURE DIRECTIONS
It remains to be seen how the Federal Circuit will respond to
rejections of claims to biotechnology inventions for lack of utility under 35
U.S.C. § 101. In particular, it is an open question whether a partial DNA
sequence such as an EST, which an applicant asserts to have utility as a tag
for an expressed gene of unknown function, is “totally incapable of
achieving a useful result.”137
It also remains to be seen how the Federal Circuit will view the
contrast between its own precedent and the PTO’s plan to allow generic
claims to any DNA molecules that encode a disclosed amino acid
sequence.138
It will be of great interest to see how the Federal Circuit
incorporates the dramatic advances in the ease with which cDNAs can be
cloned into future obviousness and written description decisions. As the
PTO has recognized, it is now technically quite routine to clone cDNAs that
encode particular known protein sequences. It is not clear to what extent the
PTO recognizes that it has become nearly as routine to clone cDNAs that
encode a homologous protein from a number of different species or strains.
33. 2002 A ROADMAP FOR BIOTECHNOLOGY PATENTS? 265
For example, today it would be trivial to clone a human insulin cDNA if one
possessed a rat insulin cDNA.
Although the new Guidelines raise some substantial new questions,
they represent a rational approach to addressing industry concerns. The
Guidelines will be helpful in navigating the prosecution of biotechnology
patents and promise to provide some food for thought or argument in
litigation, perhaps even before the Federal Circuit.
![234 AIPLA Q.J. Vol. 30:233
1
See Diamond v. Chakrabarty, 447 U.S. 303, 206 U.S.P.Q. (BNA) 193
(1980).
2
Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5,
2001)[hereinafter Utility Guidelines]; Guidelines for Examination of
Patent Applications Under the 35 U.S.C. § 112, ¶ 1, “Written
Description” Requirement, 66 Fed. Reg. 1099 (Jan. 5, 2001)[hereinafter
Written Description Guidelines]. The statutory basis for the utility
requirement is 35 U.S.C. § 101, which requires that a patentable
invention be “useful.” 35 U.S.C. § 101 (2000). The statutory basis for the
written description requirement is 35 U.S.C. § 112, ¶ 1, which requires
that the patent application contain a written description of the
invention. 35 U.S.C. § 112, ¶ 1 (2000).
I. INTRODUCTION
One of the most valuable assets a pharmaceutical or biotechnology
company can own is a proprietary position on genetic material that will
provide the foundation for developing commercial biological and chemical
products. The appropriate requirements for patenting genetic material are
a subject of vigorous national and international debate.
In the United States, the basic criteria for patenting advancements in
genetic research have been established by the United States Court of
Appeals for the Federal Circuit, following the United States Supreme Court
decision in Diamond v. Chakrabarty.1
However, several organizations have
expressed concerns that unduly broad genetic patents still may be granted
and thereby stifle innovation.
In an attempt to address such concerns and to account for Federal
Circuit precedent, the United States Patent and Trademark Office (“PTO”)
hasrecentlyissuedguidelinesrelating totheU.S.patentabilityrequirements
of“utility” and“writtendescription”(collectively,the“Guidelines”).2
These
Guidelines address various comments made about an earlier version called](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)