Patent law is a contract between government and inventor. A patent is a grant of legal monopoly, and
its resulting commercial benefit, by government under which the
inventor/patentee can exclude others from making and using his invention. The quid pro quo of this monopoly is the
inventor/patentee's disclosure of the invention to the public in the patent
document, knows as "specification."[1]
Similar to clauses in a contract defining the rights of
contractees, specification and claims in a patent carefully crafts the boundary
of inventor's monopoly territory. On the
one hand, the boundary defining the excludable subject matter must protect the
inventor, so that commercial development is encouraged; on the other hand, the
claims must be commensurate with the inventor's contribution, so that the scope
of the protection will not be overbroad.
This subtle balance is maintained by enablement, written description,
best mode and definiteness, collectively termed the "disclosure
requirements" in the patent law.[2]
According to
the current law on the written description requirement, a patent specification
must describe the claimed invention in sufficient detail such that one skilled
in the art would reasonably conclude that the inventor had possession of the
claimed invention. Possession may be
shown in a variety of ways including description of an actual reduction to
practice, or by showing that the invention was "ready for patenting"
such as by the disclosure of drawings or structural chemical formulas that show
that the invention was complete, or by describing distinguishing identifying
characteristics sufficient to show that the applicant was in possession of the
claimed invention.
Because this area of patent law has changed little from the
Patent Act of 1793,[3] the
records are devoid of legislative history on the topic. Even though sufficient written description of
an invention has been required in case
law from at least the early nineteenth century,[4] many commentators have associated modern
jurisprudence on the subject with the 1967 case In re Ruschig,[5]
which declared the written description as a distinct requirement for
patentability.[6] Since then, the issue has been repeated in
the case law from U.S. Court of Appeals for the Federal Circuit, yet it remains
an unsettled area of law.
The major
conflict regarding the written description requirement is whether the
enablement requirement and the written description requirement, both from 35
U.S.C. §112, first paragraph, are separate requirements that must be fulfilled
by the patentee. In the 1991 case Vas-Cath, Inc. v. Mahurkar[7]
the court clarified this unresolved question by asserting:
35 U.S.C.
§112, first paragraph, requires a "written description of the
invention" which is separate and distinct from the enablement
requirement. The purpose of the "written
description" requirement is broader than to merely explain how to
"make and use"; the applicant must also convey with reasonable clarity
to those skilled in the art that, as of the filing date sought, he or she was
in possession of the invention.[8]
Moreover, Vas-Cath explained that although an exact description of the
claimed subject matter is not required for compliance, "the description
must clearly allow persons of ordinary skill in the art to recognize that [the
applicant] invented what is claimed"[9]
and that "compliance with the 'written description' requirement of §112 is
a question of fact, to be reviewed under the clearly erroneous standard."[10] Therefore, the Vas-Cath court established the distinction between the written
description and enablement requirements, and set a clear standard to be relied
upon and expounded upon in future written description requirement cases.
Despite
Vas-Cath Court
This article traces the historical development of the written
description requirement, review the case law supporting a distinct and separate
written description requirement as a priority doctrine and later, a general disclosure
doctrine, summarizes the prevalent two theories--the independent written
description theory and the for-enablement written description theory, and studies
the reasons why the independent written description theory is the proper
direction for the written description requirement with the explanation that the
theory better equips the U.S. patent system to cope with the unpredictability
of unconventional technologies.
Part I studies the statutory requirement for written
description and enablement requirement, and identifies the confusion between
the two requirements. Part II reviews
the historical development of the written description requirement and its
gradual separation from the enablement requirement as a priority doctrine. Part III examines the evolution and clarification
of role of the written description requirement as a general disclosure doctrine
in the context of biotechnology patenting.
Part IV summarizes the current two competing views on written description
requirement. Part V argues that the
independent written description theory is the natural growth of the case law
and better equips the U.S. U.S.
I. The Statutory Requirements for Written Description and
Enablement Requirement
a. Statutory Requirement of Written Description Requirement
According to 35
U.S.C. §112, first paragraph, to comply with the written description requirement,
a patent specification must describe the claimed invention in sufficient detail
such that one skilled in the art would reasonably conclude that the inventor
had possession of the claimed invention.
Case law has established that "possession" may be shown in a
variety of ways including description of an actual reduction to practice, or by
showing that the invention was "ready for patenting" such as by the
disclosure of drawings or structural chemical formulas that show that the
invention was complete, or by describing distinguishing identifying
characteristics sufficient to show that the applicant was in possession of the
claimed invention.
The test for
determining compliance with written description requirement is whether the
disclosure of the application as originally filed reasonably conveys to the
artisan that the inventor had possession at that time of the later claimed
subject matter, rather than presence or absence of literal support in the
specification for the claim language.
b. Basic elements of Enablement Requirement
According to the first paragraph of 35
U.S.C. § 112, a patent application must provide sufficient disclosure to
enable a person skilled in the art to make and use the claimed invention. One element of the enablement requirement prescribes the
relationship between the claims and the disclosure in the specification. In essence, claims should not be of "undue
breadth" in view of the scope of the disclosure provided by the
specification. If no reasonable correlation exists between
the narrow disclosure in the specification and the broad claim, the
specification does not meet the requirements of enablement under 35 U.S.C. 112,
first paragraph.
The second element of
enablement requires that the specification must disclose any claimed invention
in such clarity as to enable one skilled in the art to practice the invention
without "undue experimentation."[13] Factors to be considered in determining
whether a disclosure would require undue experimentation have been summarized
by the court in In re Forman,[14]
as: (1) the quantity of experimentation necessary, (2) the amount of direction
or guidance presented, (3) the presence or absence of working examples, (4) the
nature of the invention, (5) the state of the prior art, (6) the relative skill
of those in the art, (7) the predictability or unpredictability of the art, and
(8) the breadth of the claims.[15]
c. The confusion between the written description and
enablement requirement
In United States
The U.S.
In contrast,
the policy underlying the written description requirement is to provide the
public with the benefit of its bargain with the patentee - the disclosure of
valuable technical information, and to ensure that the scope of the monopolies
granted to inventors in return for their technical disclosures is commensurate
with the scope of those disclosures. Case
laws, statutes and regulations have repeatedly reinforced these underlying policies
by stating that the objectives of the written description requirements are: "to
clearly convey the information that an applicant has invented the subject
matter which is claimed";[17]
to "place the public in possession of what the applicant claims as the
invention so that the public may ascertain if the patent applicant claims
anything that is in common use, or already known";[18]
and to prevent an applicant from claiming subject matter that was not described
in the applicant as filed, and the proscription against the introduction of new
matter in a patent application[19]
serves to prevent an applicant from adding to the information content of a
patent application after it is filed.[20]
II. The
historical development of the written description requirement and its
separation from the enablement requirement.
The
requirement for a written description of the invention has been embedded in the
statutory language since the first U.S.
The Supreme Court
resurrected the written description 's scope-defining role in Evans v. Eaton,
20 U.S.
Before 1967, the United
States Court of Customs and Patent Appeals (CCPA) did not differentiate written
description from enablement. In order to
prevent applicants from adding new matter to their disclosures and date them
back to their original filing date, thus defeating an accurate accounting of
the priority of invention, the patent system must have some provision to
prevent applicants from using the amendment process to update their disclosures
(claims or specifications) during their pendency before the patent office. Therefore, the USPTO and the CCPA used a
"new matter" rejection to ensure that applicants did not update their
disclosures after the original filing date of the application before 1967. This
"new matter" rejection had a statutory basis: "No amendment
shall introduce new matter into the disclosure of the invention."[28]
In 1967, in In re Ruschig, the CCPA first separated
a new written description requirement from the enablement requirement of § 112,
and began to enforce priority as a component of the 35 U.S.C. § 112, first
paragraph, written description requirement.[29] After that, the PTO continued to use new
matter rejections under § 132, but also embraced the coterminous written
description analysis. Thus, for many years, the PTO rejected priority errors in
claims under both § 132 and § 112.
Therefore, the written description doctrine, at its inception had a very
clear function - preventing new matter from creeping into claim amendments.
The notion that written
description was a new matter doctrine and a priority policeman is reinforced in
the case of In re Wertheim in
1976,[30]
in which Judge Rich, the author of Ruschig, reiterated the purpose of written
description: "The function of the description requirement is to ensure
that the inventor had possession, as of the filing date of the application
relied on, of the specific subject matter later claimed by him."[31]
The CCPA recognized a
description of the invention requirement in 35 U.S.C. §112, first paragraph,
separate and distinct from the enablement requirement in In re Barker in 1978.[32] The court sought support to this separate and
distinct written description requirement from opinions by several other courts.[33] The view is further clarified by the courts emphasizing
that "a specification may contain a disclosure that is sufficient to
enable one skilled in the art to make and use the invention and yet fail to
comply with the description of the invention requirement."[34]
In 1981, the CCPA noted
" a rejection of an amended claim under § 132 is equivalent to a rejection
under § 112, first paragraph."[35] To avoid confusion between new matter
rejections and objections, the court chose to eliminate the § 132/§ 112
rejections and to use § 112 for new matter rejections (claims).[36] Thus the purpose of the written description doctrine, like
its corollary § 132--policed priority, did not change.
Finally, in 1991, the Federal
Circuit brightened the future of a separate and distinct written description requirement
in Vas-Cath, Inc. v. Mahurkar.[37] While acknowledging that some of its cases
concerning the written description requirement and enablement requirement are
confusing, the Federal Circuit reaffirmed that under 35 U.S.C. §112, first
paragraph, the written description requirement is separate and distinct from
the enablement requirement.
Therefore, in seeking to put the public
in possession of the invention,[38]
the written description doctrine requires that the applicant "convey with
reasonable clarity to those skilled in the art that, as of the filing date
sought, he or she was in possession of the invention."[39] For unpredictable arts, written description
doctrine "requires a precise definition, such as structure, formula,
chemical name, or physical properties."[40] It is further established by the courts that
satisfaction of the written description requirement is a question of fact.[41]
III. Further
development of written description requirement in the context of biotechnology
patenting
For a long time,
before the era of biotechnology came along, the written description was at
issue only in limited circumstances where the entitlement of priority is at
issue regarding amendment, continuation or divisional applications, or an
interference proceeding.[42] Unfortunately, this is also the case for the
seemingly unambiguous holding of a separate and distinct written description
requirement by the Vas-Cath
court. Therefore, the debates on the
identity of the written description requirement continues. In recent years,
the question of what is adequate written description in a given technology area
beyond that which enables has caused much confusion as more diverse and new
subject matters found their way into patent suits. Several recent decisions of the Federal Circuit in
biotechnology, specifically relating to gene patenting, have created so-called
"unusual" disclosure standards based on written description
requirement.
In Amgen, inc. v. Hoescht Marion
A "possession" standard was first articulated in Vas-Cath Inc. v. Mahurkar, [43]
which holds that, beyond teaching how to make and use an invention, an
applicant must convey to one skilled in the art that, as of the filing date, he
was "in possession of the invention." [44]
Although it is not immediately clear how much description is required to
evidence "possession," the Vas-Cath "possession"
standard was adopted in some subsequent cases, [45]
and embraced by the USPTO.[46]
The Federal
Circuit again considered written description requirement in the context of a
DNA sequence in Fiers v. Revel 984 F.2d 1164 (Fed. Cir. 1993). Fiers was a three-party interference
among Fiers, Revel, and Sugano, involving "a DNA which consists
essentially of a DNA which codes for a human fibroblast interferon-beta
polypeptide."[47] The Federal Circuit held that Fiers, who did
not disclose the nucleotide sequence of a DNA encoding human fibroblast
beta-interferon or provide such a DNA on the asserted conception date, failed
to conceive the invention of the count on that date, and confirmed that a DNA
sequence is to be treated as a chemical invention, at least with respect to
invention date and related disclosure issues.
The Federal Circuit affirmed the award of priority to Sugano and
concluded that Sugano satisfied the written description and enablement
requirements of 35 U.S.C. §112 because Sugano's disclosure included a detailed
method for obtaining a DNA coding for human fibroblast beta-interferon and it
set forth a correct nucleotide sequence of such a DNA.[48]
The
Federal Circuit's decision in Regents of
the University of California v. Eli Lilly & Co., 119 F.3d 1559
(Fed. Cir.1997) marked a turn from thirty years of precedent on the written
description requirement. For the first
time, federal circuit applied the written description requirement as a general
disclosure doctrine in place of enablement, rather than as a priority
doctrine.[49] In Lilly, The patentee, having in
possession of rat cDNA encoding insulin A and B chain amino acid sequence,
disclosed a general method of producing human insulin cDNA and a description of
the human insulin A and B chain amino acid sequences that cDNA encodes. Based on the absence of a
nucleotide-by-nucleotide recitation in the specification of the human insulin
cDNA, the court determined that the applicant had not adequately described the
invention.[50] The significance of Lilly rests on the
fact that it does not test a later claim amendment against the specification
for priority, but asserts a new free-standing disclosure requirement in place
of the statutory standard of enablement. This is the first time the Court
expanded the use of the written description requirement to original claims that
is outside the context of the entitlement of priority.
After
Lilly, the USPTO promulgated "Guidelines
for the Examination of Patent Applications Under the 35 U.S.C. 112, 1, 'Written
Description' Requirement."[51] The Guidelines are intended to assist USPTO
personnel in the examination of patent applications for compliance with the
written description requirement.[52] Along with the Guidelines, the USPTO
published training materials for patent examiners that include biotech examples
such as antibody and hybridization disclosures.[53] Each example provides a fact pattern, at
least one putative claim, an analysis describing how to determine whether each
clam meets the written description requirement, and a conclusion explaining
whether the claim is adequately described.[54]
The Federal Circuit's division in Enzo
Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) further fueled the debate on
the written description requirement after the Lily decision. The case is about a patent that was
directed to nucleic acid probes that selectively hybridize to the genetic
material of the bacteria that cause gonorrhea. The assignee deposited three
nucleotide sequences in the form of a recombinant DNA molecule within a
bacterial host in a public depository and noted their function in the
specification. On the one hand, the circuit court held that reference in a
patent specification to a deposit in a public depository, which makes its
contents accessible to the public when it is not otherwise available in written
form, constituted an adequate description of the deposited material sufficient
to comply with the written description requirement of 35 U.S.C. § 112,
paragraph 1.[55] On the other hand, Enzo disavowed the
"possession" standard articulated by the Vas-Cath court. It provides
that application of the written description requirement is not subsumed by the
"possession" inquiry and that a showing of "possession" is
only ancillary and does not of itself establish adequate written description. [56]
Therefore,
the written description - a part of the Patent Act since 1870 - has taken on a
life separate from its statutory context only since 1967. For a long time, the
written description requirement applied only for the reasons that occasioned
its judicial creation, it did not disrupt the rest of the Patent Act. However, Enzo and Lilly have
given the written description requirement a life of its own. Since the decision of the two cases, for
biotech inventions, 35 U.S.C. § 112, paragraph 1 requires a precise listing of
the DNA sequence nucleotide-by-nucleotide according to the Lilly standard.
IV. Current two competing views on written description requirement
Since the series of decisions relating to biotechnology
patents,[57]
the written description requirement has stepped into the spotlight from its
once obscure role in the shadow of the enablement requirement. But commentators as well as the Federal
Circuit have been sharply divided on whether the written description requirement
is independent of or separate from the enablement requirement. Both pro and anti-independent written
description positions are advanced by their advocates on the basis of statutory
construction, lines of cases, hypothetical, and public policy arguments.[58]
The contention on written description requirement is
highlighted in the case of Univ. of Rochester v. G.D. Searle & Co.[59] The patent at issue in Univ. of Rochester
Despite the urges
by variously-sided stakeholders and commentators on the Federal Circuit to
resolve the question en banc,[60]
the court left the question open when it declined in July 2004, by a 7-5
margin, to rehear en banc its earlier decision[61]
with the judges filing separate opinions split as to whether 35 U.S.C. §112
contains a written description requirement separate from the enablement
requirement. [62] In concurring opinions, Judges Lourie, joined
by Judges Bryson and Dyk declared that a separate written description
requirement exits. Although Judge Dyk opined that the Federal
Circuit had "yet to articulate satisfactory [written description]
standards that can be applied to all technologies," but that this was not
the proper case to do so, Judge Lourie viewed the question as well-settled by
the court's jurisprudence stating:
Three separate
requirements are contained in §112: (1) the specification shall contain a
written description of the invention; (2) the specification shall contain a
written description…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; and (3) the specification…shall set forth the best mode
contemplated by the inventor of carrying out his invention. … In common
parlance, as well as in our and our predecessor court's case law, those three requirements
are referred to as the "written description requirement," the
"enablement requirement," and the "best mode requirement," respectively.[63]
Judge Newman agreed that the written
description require was separate, but filed a dissenting opinion because she
believed the issue should have been addressed in this case. Finally, Judge Radar, Gajarsa, and Linn
dissented in two separate opinions expressing the view that 35 U.S.C. §112 does
not contain a separate written description requirement.
The Federal Circuit judges' separate opinions in Univ.
of Rochester encapsulated the two prevalent views on written description
requirement. One view, termed the
"for-enablement written description" theory by some commentators,[64]
is held by believers including Judges Rader, Linn, and Gajarsa. The proponent of this theory believe that
written description is coupled with enablement and that an enabling written
description is necessarily an adequate written description.[65] The other view is termed "independent
written description" or "beyond-enablement written description"
theory. Its supporters include Federal
Circuit judges Lourie, Newman, Bryson, Dyk and Michel.[66] They believe that the written description
requirement must be separately evaluated and satisfied, independently of the
enablement requirement.[67]
Although highlighted in the cases mostly involving
biotechnology, the independent written description requirement backed by
majority of the judges is not limited in the biotechnology, or any
unconventional technology. In fact, the Univ. of Rochester
The independent written description requirement as a
general disclosure doctrine is further emphasized by the Federal Circuit in a
recent case, LizardTech, Inc. v. Earth
Resource Mapping, Inc.[71] The case involved a patent for method of
eliminating edge artifacts when using tile-based wavelet transforms to compress
digital images. Affirming the district
court's invalidation of the patent Claim 21 and its dependent claims for
failing to satisfy the written description requirement of 35 U.S.C. §112, the
court spelled out the very essence of the independent written description
theory by stating[72]:
The "written description" clause of section 112
has been construed to mandate that the specification satisfy two closely related
requirements. First, it must describe
the manner and process of making and using the invention so as to enable a
person of skill in the art to make and use the full scope of the invention
without undue experimentation.[73] Second, it must describe the invention
sufficiently to convey to a person of skill in the art that the patentee had
possession of the claimed invention at the time of the application, i.e., that
the patentee invented what is claimed.[74]
A request for rehearing en banc was denied. Judge Lourie, joint by Judges Michel and
Newman, states in his concurring opinion: "[B]oth a written description
and a disclosure of how to make and use the invention, as well as the best mode
of carrying it out, are required by the statute"[75] An avid supporter for the independent written
description theory, Judge Lourie further declared: "the law is clear and
consistent"[76]
"that statutory written description requirement is basic to the patent
system and it is in no way limited to 'policing new matter violations' or
resolving priority disputes."[77]
Therefore,
as the current law stands, the for-enablement written description theory is a
minority position. The theory is simpler, compared to the alternative theory,
for measuring the sufficiency of patent disclosures. The satisfactoriness of
written description under this theory hinges on enablement, an approach similar
to that taken in Europe .[78] But the theory continues the historical
ambiguity between written description and enablement requirement -- the same
question remains: what amounts to adequate written description beyond that
which enables. The majority position,
the independent written description theory, requires an inventor to describe
what the invention is, in addition to what it does or how to make and use
it. The theory gives written description
requirement its own teeth in evaluating the validity of patent claims, and
ensuring that the scope of patent protection is in commensurate with inventor's
contribution to the society.
V. Independent written description
requirement is the U.S.
1. Independent written
description requirement does not discriminate against new technologies
The invalidation of
biotechnology-related patents in a series of recent Federal Circuit cases[79]
left many observers with the impression that the written description standard
is heightened for biotechnology inventions only.[80] Consequently, the resulting independent
written description theory from these cases has been perceived as a sign of
hostility towards protecting innovations in the fledgling fields of new
sciences, therefore should be removed.[81] The perception
ignores the fact that the written description requirement before biotechnology
is established in the context of traditional technological fields. Newly emerged technologies, such as
biotechnology, distinguish from the traditional technologies in that
discoveries in these new fields are conceived, made, and taught only in terms
of function, i.e. "what it does," not structure, i.e. "what it
is."[82]
Different from
more traditional area of sciences, such as chemistry, many inventions in
biotechnology could be carried out without knowing what the inventors have in
possession. A good illustration of this
function vs. structure dilemma is presented in In re Wallach, Case No. 03-1327 (Fed. Cir. 2004) Wallach discovered tumor necrosis factor
(TNF) binding proteins I and II (TBP-I and II), which selectively inhibit
cytotoxic effects of TNF. The U.S.
As discussed in Part II, a written description requirement separate
and distinct from the enablement requirement has been in existence long before
those recent disputes in biotechnology, albeit as a priority doctrine. The independent written description
requirement is only heightened and clarified as a necessary response of the patent
system to the unusual "enabled but not described" character for the
inventions in unconventional technologies such as biotechnology. As exemplified by '129 application in In
re Wallach, new technologies such as biotechnology have posed
substantial challenges to the established framework of the patent system in
adequately judging the sufficiency of the disclosure vis-à-vis the scope of the
patent claims. Feeling the strain, it is
natural for the courts to turn to the written description requirement, which is
the last statutory requirement without a clearly defined identity in a general
applicability context, therefore is the last resort under the statute with
enough flexibility for courts to maneuver.
Hence, contrary to the assertion that the independent written description requirement is used to
discriminate the new technologies, it is the new technologies that have thrust
the independent written description requirement from a limited application in priority
policing to the spotlight as a general disclosure doctrine.
Independent written description requirement has the elasticity in
adjusting to the technological progress in a particular field, therefore,
serves as a build-in buffering mechanism for the U.S.
2. The independent written description requirement grown
in the context of biotechnology patenting is an adequate standard in dealing
with other unconventional technologies such as nanotechnology
Nanotechnology, which broadly speaking is the manufacture
of structures and devices with dimensions below 100 nanometers,[85]
is another new field besides biotechnology that has experienced rapid growth in
recent years.[86] Its exponential growth has already prompted
many to hail it as "the next industrial revolution."[87] The vision of nanotechnology was first
articulated by Dr. K. Eric Drexler in a landmark paper published more than two
decades ago.[88] One principal focus of this area is
nano-machines and molecular manufacturing. Molecular manufacturing uses
nano-machines to make products on an atomic scale.[89] The unique behavior of materials at the
nanoscale[90]
offers intriguing possibilities for the cheap construction of rare molecules,
the production of light and incredibly strong microfibers, and the production
of ultrasensitive detectors.[91] Though relatively speaking nanotechnology is
still in its infant stage, massive public funding has begun pouring into
nanotechnology-related research and development (R&D), and over $ 900
million has been pledged toward further development in the coming years.[92]
Because of the theoretical potential of nanotechnology in
many aspects of human society, universities and companies are rushing to the
patent office in record numbers to patent nanotechnology inventions. This race
to the patent office is so significant that more than a dozen law firms have
established nanotechnology practice groups,[93]
and the U.S. Patent and Trademark Office (PTO) has created a new technology
cross-reference designed to track nanotechnology products. [94] Some of those patents cover improvements in
existing industries, notably semiconductors, where the continuous effort to
shrink transistor size in order to increase the speed and memory of chips has
led companies to develop sub-micron (i.e., nanoscale) components.[95] Others cover the commercial products so far
enabled by the behavior of materials at the nanoscale, such as a transparent
sunblock for windows, stain-resistant coatings for clothing or carpeting, improved
drug delivery systems, and nano-level filtration systems that can separate
pollutants or bacteria from air or water.[96] Still other patents - arguably the most
important ones - cover the basic research and production tools or building
blocks of nanotechnology,[97]
such as atomic force microscopes that can manipulate individual molecules or
carbon nanotubes that can be used to build very light, extremely strong
products - anything from bulletproof shirts to space elevators. This last
category of technology may or may not have a commercial market itself but is
necessary in order to produce downstream commercial products in the other two
areas. A recent study by Bhaven Sampat
estimates that more than 3700 nanotechnology patents were issued in the United States
Similar to inventions in biotechnology, one unique question
for nanotechnology is that an invention could be enabled by inventor's
illustration of a step-by-step procedure for making a particular nano-machine
or molecular manufacturing system, but the inventor might not be able to
describe with particularity what the invention is because of the technological
limitation. Under this circumstance,
requiring the patent to satisfy the independent written description requirement
helps to prevent overreaching claims.
Because nanotechnology is still at its infant stage, preventing
overreaching claims not only serves the public in ensuring that the inventor's
contribution to the art is in proportion to the scope of his claim of monopoly,
but also does nanotechnology itself a favor in clearing way for the growth of
the field by denying the overbroad claims that would most likely become a
hindrance to the further technological progress.
VI. Conclusion
The independent
written description theory as a general disclosure doctrine allows U.S. patent
system to better anticipate the advance of new technologies. Patent protection of inventions is essential
to provide incentive for investment and development. But to ensure continued growth, patent
protection provided must be commensurate with the contribution of the invention
to the art. The independent written
description requirement is one means of assurance. By strictly requiring independent written
description of the invention, the public is guaranteed that the inventor is in
possession of the invention when the patent application is filed. Therefore, the independent written
description requirement effective defines the scope of the invention -- the
metes and bounds that will be given exclusively, thus protects the integrity of
the U.S.
Thanks for reading.
Connie
cwan@patentonomy.com
[1]
See, e.g., Pfaff v. Walls Elecs., Inc., 525 U.S. 55, 63 (1998) ("The
patent system represents a carefully crafted bargain that encourages both the
creation and the public disclosure of new and useful advances in technology, in
return for an exclusive monopoly for a limited period of time."
[2] 35
U.S.C. §112
[3]
Act of Fed.21, 1793, ch.11 §3, 1 Stat. 318, 321. Subsequent Patent Acts
include: Act of July 4, 1836 ,
ch. 357, § 6, 5 Stat. 117, Act of July 8, 1870 , ch. 230, § 26, 16 Stat. 198, 201, and Act of
July 19, 1952 ,
ch. 950, § 1, 66 Stat. 792 (codified as amended at 35 U.S.C. §§ 1-376
(2000)). See Mark J. Steward, Written
Description Requirement of 35 U.S.C. § 112 (1): The Standard After Regents of
the University of
California Co. , 32 Ind.
[4]
See, e.g., Evans v. Eaton, 20 U.S. 356 (1822).
[5]
See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319 (Fed.
Cir. 2003); Enzo Biochem, Inc. v. Gen-Probe Inc., 63 U.S.P.Q.2d 1618, 1623-24
(Fed. Cir. 2002); Mark D. Janis, On Courts Herding Cats: Contending with the
"Written Description" Requirement, 2 Wash. U. J. L. & Pol'y 55,
59 (2000); Janice M. Muller, The Evolving Application of the Written Description Requirement to Biotechnological
Inventions, 13 Berkeley Tech. L. J. 615, 616-17 (1998).
[6]
379 F.2d 990, 995 (C.C.P.A. 1967).
[7]
935 F.2d 1555 (Fed. Cir. 1991).
[8] Id.
[9]
Vas-Cath, Inc., 935 F.2d at 1563 (quoting In re Gosteli, 872 Ff.2d 1008, 1012
(Fed. Cir. 1989)).
[10] Id.
[11]
Vas-Cath, Inc. 935 F.2d 1555, 19 U.S.P.Q.2d 111 (Fed. Cir. 1991)
[12]
See, Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991);
Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993); Regents of the University of California Co. 119 F.3d 1559 (Fed. Cir. 1997); and University of Rochester
[13]
11 Tex.
[14] In
re Forman (BPAI, 1986).
[15] Id.
[16] 35 U.S.C. 112 (1994).
[17]
In re Barker, 559 Ff.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977), cert.
denied, 434 U.S. 1064 (1978)
[18]
Evans v. Eaton, 20 U.S.
[19]
35 U.S.C. 132 and 251.
[20]
See, 35 CFR 1.71
[21]
See In re Barker, 559 F.2d 588, 592 (C.C.P.A. 1977)
[22]
See Janice M. Mueller, The Evolving Application of the Written Description
Requirement to Biotechnological Inventions, 13 Berkeley
[23]
38 House. L. Rev. 1195, 1199-1200
[24]
See id. The claim requirement in the
current patent statute is found in 35 U.S.C. section 112, P 2 (1994): "The
specification shall conclude with one or more claims particularly pointing out
and distinctly claiming the subject matter which the applicant regards as his
invention."
[25]
See id. at 592-93
[26] Id.
[27] Id.
[28]
35 U.S.C. § 132.
[29] In re Ruschig, 54 C.C.P.A. 1551, 379
F.2d 990 (CCPA 1967)
[30]
541 F.2d 257, 191 USPQ 90 (CCPA 1976)
[31] Id.
[32]
559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S.
[33]
In re Bowen, 492 F.2d 859, 864, 181 USPQ 48, 52 ( ). & Pat. App. 1974); In re Smith, 481
F.2d 910, 914-15, 178 USPQ 620, 623-25 (Cust. & Pat. App.1973); In re Moore
[34]
Fields v. Conover, 443 F.2d 1386, 1391, 58 CCPA 1366, 1372, 170 USPQ 276, 280
(1971); In re Ruschig, 379 F.2d 990, 995-96, 54 CCPA 1551, 1558-59, 154 USPQ
118, 123 (CCPA, 1967).
[35] In re Rasmussen, 650 F.2d 1212, 1214,
211 USPQ 323, 325 (CCPA, 1981).
[36] Id.
[37]
935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991)
[38]
Vas-Cath Inc. v. Mahurkar, 935 F. 2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1114 (Fed.
Cir. 1991) (citing Evans v. Eaton, 20 U.S.
[39]
Vas-Cath, 935 F.2d at 1563-64, 19 U.S.P.Q.2d at 1117 (emphasis omitted).
[40]
Fiers v. Revel, 984 F.2d 1164, 1171, 25 U.S.P.Q.2d 1601, 1606 (Fed. Cir. 1993)
[41]
Fiers, 984 Ff.2d at 1170, 25 U.S.P.Q.2d at 1606; Vas-Cath, 935 F.2d at 1562, 19
U.S.P.Q.2d at 1116.
[42]
11 Tex.
[43] 935 F.2d 1555 (Fed. Cir. 1991).
[44] Id.
[45] See, e.g., Hyatt
v. Boone, 146 F.3d 1348 (Fed. Cir. 1998).
[46] MPEP 2161 and 2163, supra note 27.
[47] Fiers
v. Revel 984 F.2d 1164 (Fed. Cir. 1993).
[48] Id.
[49] Eli
Lilly 119 F.3d 1559
[50]
119 F.3d at 1567
[51]
Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112,
1, "Written Description" Requirement, 66 Fed. Reg. 1099 (Jan. 5, 2001 ).
[52] Id.
[53]
See Synopsis of Application of Written Description Guidelines, at 59-60,
available at http://www.uspto.gov/web/menu/written.pdf
[54] Id.
[55] Id.
[56] 323 F.3d 956.
[57]
See, e.g. Eli Lilly 119 F.3d
1559; Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir.,
2002)
[58] See generally Univ.
of Rochester Univ.
of Rochester
[59] 375 F.3d 1303, 1307 (Fed. Cir. 2004)
[60] See amici briefs filed in Univ. of Rochester University of California United States Univ.
of Rochester
[61] Univ. of Rochester S. Ct. 629 (2004).
[62] Univ. of Rochester
[63] Rochester
[64]
Qin Shi, Patent system meets new sciences: is the law responsive to changing
technologies and industries?, 61 N.Y.U. Ann. Surv. Am. L. 317, 326 (2005)
[hereinafter Shi (2005)].
[65] See Univ. Rochester
[66]
LizardTech, Inc. v. Earth Resource Mapping, Inc. 433 F.3d 1373, 1375 (Fed. Cir.
2006)
[67] See Enzo Biochem., 323 F.3d 956; Regents of the Univ. of California Co. , 119 F.3d 1559 (Fed. Cir. 1997); and Univ. of Rochester
[68] 23
Biotechnology L. Rep. 616, 619.
[69] Univ. of Rochester
[70]
23 Biotechnology L. Rp. 616, 619. See, e.g. In re Curtis, 354 F.3d 1347 (Fed.
Cir. 2004) (dental floss); Tronzo v. Biomet, Inc. v. Berkline Corp., 134 F.3d
1473 (Fed. Cir. 1998) (sectional sofas); Lock-wood v. Am. Airlines, Inc., 107
F.3d 1565 (Fed. Cir. 1997) (automated sales terminals); Vas-Cath (double lumen
catheters).
[71]
424 Ff.3d 1336, 76 U.S.P.Q.2d 1724.
[72]
LizardTech 424 F.3d at 1344-45.
[73]
See Tyler Boston U.S.
[74]
See O'Reilly v. Morse, 56 U.S.
[75]
LizardTech, Inc. v. Earth Resource Mapping, Inc. 433 F.3d 1373, 1375 (Fed.
Cir.2006)
[76]
LizardTech, 433 F.3d at 1375
[77] Id.
[78] The European Patent Convention requires that the applicant
"disclose the invention in a manner sufficiently clear and complete for it
to be carried out by a person skilled in the art." European Patent
Convention, art. 83 (2002).
[79] Regents of the University
of California Co. , 119 F.3d 1559 (Fed. Cir.
1997), and its progeny invariably relate
to biotechnology inventions.
[80] See, e.g., Univ. of Rochester, 375 F.3d 1303, 1314
(listing in appendix to Judge Rader's dissenting opinion post-Eli Lilly
commentaries and law reviews discussing the written description standard); Burk
& Lemley (2002), supra note 17, at 1173-74; R. Polk Wagner, Of Patents and Path
Dependency: A Comment on Burk and Lemley, 18 Berkeley Tech. L.J. 1341
(2003).
[81]
Stephen J. Burdick, Moba v. Diamond Automation, Inc.: Questioning the separate
written description requirement, 19 Berkeley
[82]
Shi (2005), supra note 31, at 327
[83] 119 F.3d 1559 (Fed. Cir. 1997)
[84]
23 Biotechnology L. Rp. 616, 619.
[85] 15 Alb. L.J. Sci. & Tech. 477
[86] See generally Foresight Institute website at
www.foresight.org/NanoRev/index.html and Zyvex website at www.zyvex.com/nano/.
[87] Nat'l Sci. & Tech. Council, Comm. on Tech., Subcomm. on
Nanoscale Sci., Eng'g, & Tech., National Nanotechnology Initiative:
Research and Development Supporting the Next Industrial Revolution 1-2, at
http://www.nano.gov/html/res/fy04-pdf/nni04 budget supplement.pdf (last visited
Feb. 17, 2005 )
[hereinafter Nat'l Sci. & Tech. Council].
[88] K. Eric Drexler, Molecular Engineering: An Approach to the
Development of General Capabilities for Molecular Manipulation, 78 Proc. Nat'l
Acad. Sci. USA 5275 (1981).
[89] While offering many benefits, this field also has
environmental, medical, and security implications. Detailed analysis of these
various aspects is beyond the scope of this article.
[90] Steve Jurvetson offers one striking example of size-related
changes in the behavior of materials: "Consider the simple aluminum Coke
can. If you take the inert aluminum metal in that can and grind it down into a
powder of 20-30 nm particles, it will spontaneously explode in air. It becomes
a rocket fuel catalyst." Steve Jurvetson, Transcending Moore
[91] For a general discussion of the science of nanotechnology
accessible to the lay reader, see Ratner & Ratner, supra note 1.
[92] Nat'l Nanotechnology Initiative, NNI Funding, at
http://www.nano.gov/html/about/funding.html (last visited Feb. 17, 2005 ) [hereinafter NNI
Funding].
[93] Intellectual property law firms with separate nanotechnology
groups include, among others: Sterne, Kessler, Goldstein & Fox; Brinks
Hofer Gilson & Lione; Buchanan Ingersoll; Fenwick & West; Fish &
Richardson; Fitzpatrick, Cella, Harper & Scinto; Foley & Lardner;
Greenberg Traurig; DLA Piper Rudnick Gray Cary; Howrey; Pillsbury Winthrop Shaw
Pittman; Preston Gates & Ellis; Sughrue Mion; and Townsend and Townsend and
Crew.
[94] See Nanotech Cross-Reference Digest Is First Step in
Improved Examination, PTO Official Says, 69 Pat. Trademark & Copyright J.
(BNA) No. 1695, at 25 (Nov.
12, 2004 ). This should help to deal with the difficulty of finding
prior art in a technology that crosses many product disciplines. See Bawa,
supra note 5, at 38 ("Searching for nanotechnology-related patents and
publications is complicated relative to other technology areas."); Bhaven
N. Sampat, Examining Patent Examination: An Analysis of Examiner and Applicant
Generated Prior Art 25 (NBER Summer Institute, Working Paper, 2004), available
at http://faculty.haas.berkeley.edu/wakeman/ba297tspring05/Sampat.pdf (noting
that nanotech patents appear in hundreds of different PTO technology classes).
[95] See, e.g., Method
& System for Optically Sorting &/or Manipulating Carbon Nanotubes, U.S.
Patent No. 6,835,911 (filed Dec. 28, 2004); Thin Film Field Effect Transistor,
U.S. Patent No. 6,720,617 (filed Apr. 13, 2004); Magnetic Storage Medium Formed
of Nanoparticles, U.S. Patent No. 6,162,532 (filed Dec. 19, 2000).
[96] See, e.g., Nanocrystal-Containing Filtration Media, U.S.
Patent No. 6,662,956 (filed Dec. 16, 2003); Nanoparticle-Based Permanent
Treatments for Textiles, U.S. Patent No. 6,607,994 (filed Aug. 19, 2003); Ultraviolet
Resistant Pre-Mix Compositions & Articles Using Such Compositions, U.S.
Patent No. 6,337,362 (filed Jan. 8, 2002); Nanoparticles Containing the R(-)
Enantiomer of Ibuprofen, U.S. Patent No. 5,718,919 (filed Feb. 17, 1998)
(claiming a nanoparticle coating for a drug delivery system).
[97] Siva Vaidhyanathan takes the "building-block"
analogy a step further, asserting that nanotechnology patents are akin to
patents on bricks. Siva Vaidhyanathan, Nanotechnology and the Law of Patents: A
Collision Course, in Nanotechnology and Society: A Multidisciplinary Evaluation
(Geoffrey Hunt & Michael Mehta eds., forthcoming 2005), available at http://ssrn.com/abstract=740550.
[98] Sampat, supra note 8, at 24. Running the same search for
the same dates in LexisNexis produces 5796 patents. It is unclear what explains
the discrepancy.
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