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Patents / Biotechnology / US Biotechnology Practice |
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4.4 Enablement Objections
possible under 35 USC § 112 occur more commonly in the Patent Office during
prosecution than in litigation relating to granted patents. The standard of
disclosure required for U.S. patents is still high as compared to that in many
other countries and one must always be careful to ensure that a full
description of the invention is filed so that the disclosure enables one
skilled in the art to put the invention into practice without undue
experimentation.
[43]
The fact that some experimentation is required does not condemn the
specification
[44]
nor does the fact that the skilled worker may have need to consult outside
references to produce an operable result. The specification must be enabling
as of the date of filing the application.
[45]
In particular it should be noted that the description must contain sufficient
information to make and use the invention, the "use" requirement being one that
has in recent years caused problems in inventions relating to pharmaceuticals
where one may not know, perhaps, the required dosages to be used for a drug
until clinical testing has been carried out.
[46]
In this context it should be noted that references to "the invention" in 35
USC § 112 refer to the invention as it is claimed in each of the claims so that
the specification may be enabling for some of the claims but not for others.
[47] When
considering the enablement test, the person who must be able to utilize the
specification to make or use the invention is one "skilled in the art to which
the invention pertains or with which it is most nearly connected" and so a
reasonable degree of expertise can be assumed. In
In
re Howarth
[48]
the Court of Customs and Patent Appeals noted that the relevant art, which it
could be assumed that one skilled in the art had available in seeking to
implement the teaching of the patent, was not only the actual knowledge that the
worker had but also what he or she would know to search out. However, unlike
the position when considering the prior art that was relevant to questions of
novelty and obviousness, it did not include everything that had ever been
published. The court pointed out:
Well
known text books in English are obvious research materials. Similarly, public
records concerning U.S. patents are likely to be checked and information in
them is reasonably accessible in view of published abstracts and our
classification system. ... We do not exclude the possibility that foreign
patents and foreign language printed publications may also be relevant... .
On
the other hand, when no guide at all has been given, as here, an applicant must
show that anyone skilled in the art would actually have possessed the requisite
knowledge or would reasonably be expected to check the source which the
applicant relies upon to complete his disclosure and would be able to locate
the information with no more than reasonable diligence.
The
applicant had omitted to describe how to produce a starting material needed to
carry out the claimed invention and wished to rely on disclosures in Rhodesian,
Panamanian and Luxembourg patents to show that the information on how to
produce the starting material was known. The court held that these references
were too obscure to be used for this purpose.
The
question of what constitutes undue experimentation was considered by the
Federal Circuit in In re Wands[49]
where the Court noted a prior decision of the PTO Board of Appeals
[50]
which had listed factors to be considered and then applied them to the case
before it. The factors to be considered were:
(1)
the quantity of experimentation necessary;
An
example of the combination of the last two factors leading to a conclusion of
non-enablement is
In
re Vaeck
[51]
where it was held that the lack of knowledge about cyanobacteria ("a diverse
and relatively poorly studied group of organisms") and claims to a chimeric
gene and cyanobacteria containing it resulted in the disclosure failing to
provide enablement for such claims. The disclosure did provide enablement for
claims to certain specific plasmids that had been constructed containing the
gene. The Court opined that
There is no reasonable correlation between the narrow disclosure in appellants' specification [of only one species of cyanobacteria in the examples and nine genera - out of 150 known genera- mentioned in the specification] and the broad scope of protection sought in the claims encompassing gene expression in any and all cyanobacteria. A
similar theme was stated in
Genentech
Inc. v. NovoNordisk A/S:[52]
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In
the chemical field, there have been cases that have held that as long as the
means for carrying out the invention is fully disclosed, there is no absolute
requirement to include working examples in the specification and that the
absence of such examples does not
ipso
facto
mean that the patent is invalid for failure to provide enabling disclosure or
describe the best mode.
[53]
However, it would be foolhardy to make a practice of omitting examples from
chemical patent specifications. In the area of genetic engineering, the PTO is
still reluctant to accept that anything that is not exemplified could in fact
be produced without undue experimentation. Prophetic or paper examples are
often included in United States patent applications to provide appropriate
disclosure. This practice has been sanctioned by the courts. It should,
however, be noted that if this is done the examples should not be written in
the past tense so as to give the false impression that they have been carried
out.
[54] The
corollary of the strict enablement requirement is that the claims of the patent
may be drafted broadly to cover the invention described irrespective of whether
all possible embodiments have been reduced to practice.
Exactly
how much disclosure is needed to support a broad claim is a matter of fact in
each case. As was noted in
In
re Fisher: [55]
the scope of the claims must bear a reasonable correlation with the scope of enablement provided by the specification to persons of ordinary skill in the art. In cases involving predictable factors such as mechanical or electrical elements a single embodiment provides broad enablement in the sense that, once imagined, other embodiments may be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved. Subsequent
cases have down-played a distinction between chemical and non-chemical
inventions and emphasized that the key question is the predictability of the
art in question.
[56]
However, in
Genentech Inc. v. Novo Nordisk A/S [57]
the Federal Circuit held a chemical patent invalid for lack of enabling
disclosure when the specification disclosed no specific starting materials or
conditions to be used. The court stated:
(such) failure to meet the enablement requirement... cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification not the knowledge of one skilled in the art, that must supply the novel aspect of the invention in order to constitute adequate enablement. National
Recovery Technologies v. Magnetic Separation Systems
[58]
was according to the Federal Circuit:
a classic example of a claim that is broader than the enablement taught in the specification. The ideal solution to [the] problem is clear ... Claim 1 claims this ideal solution in the step of "selecting for processing those of said process signals as pass through irregularities in the bodies of said material items." However, the specification does not describe how to perform this ideal selection step. In
effect the claim defined the problem to be solved but there was no description
as to how to solve it.
Similar
problems may arise in cases where the invention claimed relates to a single
element defined only by function.
[59] In
any case care must be taken to avoid drafting a claim that is so broad as to
cover a significant number of inoperative embodiments (i.e. those lacking any
utility) but it is not necessary that all of the embodiments claimed have a
high degree of utility.
[60]
On the other hand skillful drafting so as to confine the claims only to those
embodiment that fulfill the promise of the specification may, as long as those
skilled in the art can determine which is which without undue experimentation,
serve to avoid some of the potential problems in this area.
[61] It
should particularly be noted that 35 USC § 112 in paragraph 6 specifically
provides that in claims for a combination of integers, each of the integers may
be recited in the claim in "means for" or “step for” form and that
use of this form is to be construed to cover not only the means described in
the specification, but equivalents thereto. Where one wishes to rely on such
functional language in the claims therefore it is important to describe, at
least in outline as many alternatives as possible.
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