Ex Parte Chung et al

Board of Patent Appeals and Interferences

Nov 22, 2004

09788476 (B.P.A.I. Nov. 22, 2004)

1 We note that a request for oral hearing was made on pages 5-6 of the Reply
Brief. Requesting oral hearing in a Reply Brief did not comply with the then existing
provisions of 37 CFR § 1.194(b)(“If appellant desires an oral hearing, appellant must
file, in a separate paper, a written request for such hearing . . ..”). In view of our
disposition of the appeal, appellants’ request for oral hearing is moot.
The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte CHING M. CHUNG,
LILY CHAN,
KELI OU,
SHAO-EN ONG,
TECK K. SEOW,
CYNTHIA R.M.Y. LIANG
MENG L. CHOONG, and
LI K. TAN
__________
Appeal No. 2004-2201
Application No. 09/788,476
__________
ON BRIEF1
__________
WILLIAM F. SMITH, MILLS, and GRIMES, Administrative Patent Judges.
WILLIAM F. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the examiner’s refusal to allow
claim 1. Claims 15-17 are stated by appellants to have been indicated allowable by the
examiner. Appeal Brief received December 10, 2003, page 2.
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1. An isolated nucleic acid comprising the nucleotide sequence of SEQ ID NO:1
or SEQ ID NO:3 or a nucleotide sequence, having at least about 60% similarity to the
full length of SEQ ID NO:1 or SEQ ID NO:3, that hybridizes to SEQ ID NO:1 or SEQ ID
NO:3 under conditions of 0.1 x SSC buffer, 0.1% w/v SDS, at a temperature of at least
65NC, wherein an mRNA corresponding to said nucleic acid is differentially or
preferentially expressed in human hepatocellular carcinoma tissue or tissue from
pancreatic adenocarcinoma relative to other tissue in said subject and/or in subjects not
diagnosed with this condition.
Claim 1 stands rejected under 35 U.S.C. § 112, first paragraph (written
description and enablement). The examiner does not rely upon any evidence in support
of these rejections. We reverse.
Background
Appellants discuss the present invention at page 21 of the specification as
follows:
The present invention is described hereinafter with reference to the
detection of one particular gene designated hcc-1 from the human
hepatocellular carcinoma cell line, HCC-M. The nucleotide sequence of
hcc-1 is provided in SEQ ID NO:1. The corresponding expression product
is a protein designated HCC-1 and this comprises an amino acid as set
forth in SEQ ID NO:2. A PCR extended form for use in a vector is shown
in SEQ ID NO:3.
As seen, claim 1 is directed to an isolated nucleic acid comprising the nucleotide
sequence of SEQ ID NO:1 or SEQ ID NO:3. In addition, claim 1 comprises a nucleotide
sequence having at least about 60% similarity to the full length of SEQ ID NO:1 or SEQ
ID NO:3 that hybridizes to SEQ ID NO:1 or SEQ ID NO:3 under specified conditions. In
addition, the third nucleotide sequence encompassed by claim 1 is required to have an
mRNA that corresponds thereto that is differentially or preferentially expressed in
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human hepatocellular carcinoma tissue or tissue from pancreatic adenocarcinoma
relative to other tissue in the subject and/or in subjects not diagnosed with this
condition.
Discussion
1. Written Description.
The Federal Circuit discussed the application of the written description
requirement to inventions in the field of biotechnology in University of California v. Eli
Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997), stating
that “[a] written description of an invention involving a chemical genus, like a description
of a chemical species, ‘requires a precise definition, such as by structure, formula, [or]
chemical name,’ of the claimed subject matter sufficient to distinguish it from other
materials.” Id. at 1567, 43 USPQ2d at 1405. The court also stated that
a generic statement such as ‘vertebrate insulin cDNA’ or ‘mammalian
insulin cDNA,’ without more, is not an adequate written description of the
genus because it does not distinguish the genus from others, except by
function. It does not specifically define any of the genes that fall within its
definition. It does not define any structural features commonly possessed
by members of the genus that distinguish them from others. One skilled in
the art therefore cannot, as one can do with a fully described genus,
visualize or recognize the identity of the members of the genus. A
definition by function, as we have previously indicated, does not suffice to
define the genus because it is only an indication of what the gene does,
rather than what it is.
Id. at 1568, 43 USPQ2d at 1406. The court concluded that “naming a type of material
generally known to exist, in the absence of knowledge as to what that material consists
of, is not a description of that material.” Id.
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Finally, the court addressed the manner by which a genus of cDNAs might be
described. “A description of a genus of cDNAs may be achieved by means of a
recitation of a representative number of cDNAs, defined by nucleotide sequence, falling
within the scope of the genus or of a recitation of structural features common to the
members of the genus, which features constitute a substantial portion of the genus.” Id.
Both appellants and the examiner believe that the written description issue raised
in this rejection is similar to the issue raised in Example 9 of the training materials
issued in conjunction with the USPTO written description guidelines. See, “Synopsis of
Application of Written Description Guidelines,” at 35, available at
http://www.uspto.gov/web/menu/written.pdf. The hypothetical claim which is the subject
of Example 9 of the Guidelines reads as:
an isolated nucleic acid that specifically hybridizes under highly stringent
conditions to the complement of the sequence set forth in SEQ ID NO:1,
wherein said nucleic acid encodes a protein that binds to a dopamine
receptor and stimulates adenylate cyclase activity.
We first note that the hybridization conditions set forth in claim 1 on appeal are
stated to be “high stringency.” Specification, page 25, lines 3-4. The examiner’s
reasoning as to why the present fact situation is not analogous to that set forth in
Example 9 of the Guidelines is as follows:
In the hypothetical claim 1 of Example 9 in the Guidelines, the structure
of the claimed genus encodes a protein with the recited function. In other
words, the recited function is dictated by the chemical structure of the
claimed genus.
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However, unlike the situation in Example 9 of the Guidelines, the
instantly recited function is not associated with the structural feature of
claimed genera, but associated with human disease status. In the instant
claim 1, the recited function is not dictated by chemical structure of the
claimed genus but dictated by other events i.e. that pancreatic
adenocarcinoma or HCC is developed in a host. In other words, the
expression is not function associated with the structure but a reaction of a
human body to certain stimuli, in the instant case the development of HCC
or pancreatic adenocarcinoma.
In summary, the functional characteristic recited is uncoupled with the
structure of the claimed genus. There is no correlation between the
chemical structure of the claimed genus and the recited function.
Therefore the recited functional language describing the claimed genera
does not adequately describe the common feature of claimed generic
nucleic acid molecule.
Examiner’s Answer, pages 8 and 9.

The analysis of the reasoning set forth in Example 9 of the Guidelines as to why
hypothetical claim 1 of that example complies with the written description requirement is
as follows:
Now turning to the genus analysis, a person of skill in the art would not
expect substantial variation among species encompassed within the scope
of the claims because the highly stringent hybridization conditions set forth
in the claim yield structurally similar DNAs. Thus, a representative
number of species is disclosed, since highly stringent hybridization
conditions in combination with the coding function of DNA and the level of
skill in the art are adequate to determine that applicant was in possession
of the claimed invention.
Guidelines at 36-37.
We disagree with the examiner’s analysis that claim 1 on appeal does not comply
with the written description requirement because the expression of the claimed nucleic
acid is “not function associated with the structure but a reaction of the human
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body to certain stimuli, in the instant case the development of HCC or pancreatic
adenocarcinoma.” Example 9 of the Guidelines does not place any restriction as to how
the coding function of the DNA may be claimed. A determination whether a given
nucleic acid is within the scope of the hypothetical claim of Example 9 of the Guidelines
would require expressing the nucleic acid and testing the protein to determine whether it
binds to a dopamine receptor and stimulates adenylate cyclase activity. A
determination whether a given nucleic acid is within the scope of claim 1 would also
require testing, albeit different testing. According to the terms of claim 1, an mRNA
corresponding to the nucleic acid must be differentially or preferentially expressed in
human hepatocellular carcinoma tissue or tissue from pancreatic adenocarcinoma
relative to other tissue in said subject and/or in subjects not diagnosed with this
condition. The examiner states that the functional characteristic recited in claim 1 is
“uncoupled with the structure of the claim genus,” Examiner’s Answer, page 9, but does
not explain why that is significant in determining whether claim 1 complies with the
written description analysis. The training materials are not the end-all of a written
description analysis. The fact that a given claim under review does not fit squarely
within one of the examples does not mean that that claim does not comply with the
written description requirement. Rather than merely pointing out that claim 1 differs
from the hypothetical claim in Example 9 of the Guidelines, an analysis is needed from
the examiner explaining why the function set forth in claim 1 is not an adequate
identifier of the claimed genus of nucleic acids. Instead, all we have is the examiner’s
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conclusion that claim 1 on appeal is different from the hypothetical claim of Example 9
of the Guidelines and therefore claim 1 on appeal does not comply with the written
description requirement. This is insufficient.
The examiner’s rejection under 35 U.S.C. § 112, first paragraph (written
description), is reversed.
2. Enablement.
In stating the rejection on pages 5-6 of the Examiner’s Answer, the examiner has
focused on the purported need to screen a “large quantity of clinical samples” in order to
enable claim 1 throughout its scope. In reviewing the examiner’s response to
arguments in regard to this rejection on pages 10-13 of the Examiner’s Answer we find
the examiner again focuses on the need to screen “a large quantity of clinical samples.”
Id., page 10. As stated at page 11 of the Examiner’s Answer, “in order to make the full
scope of the invention, one skilled in the art has to screen a large quantity of clinical
samples from liver or pancreatic tissue of patients having HCC or pancreatic
adenocarcinoma, followed by sequence [sic] the nucleic acid composition.”
As set forth in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564,
37 USPQ2d 1618, 1623 (Fed. Cir. 1996):
In unpredictable art areas, this court has refused to find broad generic
claims enabled by specifications that demonstrate the enablement of only
one or a few embodiments and do not demonstrate with reasonable
specificity how to make and use other potential embodiments across the
full scope of the claim. See, e.g., In re Goodman, 11 F.3d 1046, 1050-52,
29 USPQ2d 2010, 2013-15 (Fed. Cir. 1993); Amgen, Inc. v. Chugai
Pharmaceutical Co., 927 F.2d. 1200, 1212-14, 18 USPQ2d 1016, 1026-
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28 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991); In re Vaeck, 947 F.2d at
496, 20 USPQ2d at 1445. Enablement is lacking in those cases, the court
has explained, because the undescribed embodiments cannot be made,
based on the disclosure in the specification, without undue
experimentation. But the question of undue experimentation is a matter of
degree. The fact that some experimentation is necessary does not
preclude enablement; what is required is that the amount of
experimentation ‘must not be unduly extensive.’ Atlas Powder Co., v. E.I.
DuPont De Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413
(Fed. Cir. 1984). The Patent and Trademark Office Board of Appeals
summarized the point well when it stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
reasonable amount of guidance with respect to the direction
in which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of
the invention claimed.
Ex parte Jackson, 217 USPQ 804, 807 (1982).
What is missing is an analysis from the examiner as to why the amount of work
required to practice the invention of claim 1 throughout its scope would be considered
undue instead of routine. It is insufficient for an examiner to merely point out that it is
necessary to “screen a large quantity of clinical samples.” Examiner’s Answer, page 11.
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Accordingly, the examiner’s rejection under 35 U.S.C. § 112, first paragraph
(enablement) is reversed.
The decision of the examiner is reversed.
REVERSED
)
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Eric Grimes )
Administrative Patent Judge )
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