United States Court of Appeals,
Federal Circuit.
In re Thomas F. DEUEL, Yue-Sheng Li, Ned R. Siegel and Peter G. Milner.
No. 94-1202.
March 28, 1995.
Inventors applied for patent for deoxyribonucleic acid (DNA) and complementary
DNA (cDNA) molecules encoding proteins that stimulated cell division. After
patent examiner rejected claims as unpatentable on grounds of obviousness and
the Patent and Trademark Office Board of Patent Appeals and Interferences affirmed,
inventors appealed. The Court of Appeals, Lourie, Circuit Judge, held that:
(1) combination of prior art reference teaching method of gene cloning, together
with reference disclosing partial amino acid sequence for a protein that stimulated
cell division, did not render claims prima facie obvious; (2) conceived method
of preparing some unidentified DNA does not define it with precision necessary
to render it obvious over protein it encodes; and (3) patent claims generically
encompassing all DNA sequences encoding human and bovine proteins to stimulate
cell division were not invalid as obvious.
Reversed.
*1553 G. Harley Blosser, Senniger, Powers, Leavitt & Roedel, of St. Louis,
MO, argued for appellants. With him on the brief was Donald G. Leavitt.
Donald S. Chisum, Morrison & Foerster, Seattle, WA, argued for amicus curiae,
The Biotechnology Industry Ass'n and The Bay Area Bioscience Center. With him
on the brief were Debra A. Shetka, Morrison & Forester, Palo Alto, CA and
Robert P. Blackburn, Emeryville, CA.
Teddy S. Gron, Acting Associate Sol., Arlington, VA, argued for appellee. With
him on the brief was Albin F. Drost, Acting Sol. Nancy J. Linck, Office of the
Sol., Arlington, VA, represented appellee.
Before ARCHER, Chief Judge, NIES and LOURIE, Circuit Judges.
LOURIE, Circuit Judge.
Thomas F. Deuel, Yue-Sheng Li, Ned R. Siegel, and Peter G. Milner (collectively
"Deuel") appeal from the November 30, 1993 decision of the U.S. Patent
and Trademark Office Board of Patent Appeals and Interferences affirming the
examiner's final rejection of claims 4-7 of application Serial No. 07/542,232,
entitled "Heparin-Binding *1554 Growth Factor," as unpatentable on
the ground of obviousness under 35 U.S.C. § 103 (1988). Ex parte Deuel,
33 USPQ2d 1445 (Bd.Pat.App.Int.1993). Because the Board erred in concluding
that Deuel's claims 5 and 7 directed to specific cDNA molecules would have been
obvious in light of the applied references, and no other basis exists in the
record to support the rejection with respect to claims 4 and 6 generically covering
all possible DNA molecules coding for the disclosed proteins, we reverse.
BACKGROUND
The claimed invention relates to isolated and purified DNA and cDNA molecules
encoding heparin-binding growth factors ("HBGFs"). [FN1] HBGFs are
proteins that stimulate mitogenic activity (cell division) and thus facilitate
the repair or replacement of damaged or diseased tissue. DNA (deoxyribonucleic
acid) is a generic term which encompasses an enormous number of complex macromolecules
made up of nucleotide units. DNAs consist of four different nucleotides containing
the nitrogenous bases adenine, guanine, cytosine, and thymine. A sequential
grouping of three such nucleotides (a "codon") codes for one amino
acid. A DNA's sequence of codons thus determines the sequence of amino acids
assembled during protein synthesis. Since there are 64 possible codons, but
only 20 natural amino acids, most amino acids are coded for by more than one
codon. This is referred to as the "redundancy" or "degeneracy"
of the genetic code.
FN1. For a more extensive discussion of recombinant DNA technology, see In re
O'Farrell, 853 F.2d 894, 895-99, 7 USPQ2d 1673, 1674-77 (Fed.Cir.1988); Amgen
Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed.Cir.),
cert. denied, 502 U.S. 856, 112 S.Ct. 169, 116 L.Ed.2d 132 (1991).
DNA functions as a blueprint of an organism's genetic information. It is the
major component of genes, which are located on chromosomes in the cell nucleus.
Only a small part of chromosomal DNA encodes functional proteins.
Messenger ribonucleic acid ("mRNA") is a similar molecule that is
made or transcribed from DNA as part of the process of protein synthesis. Complementary
DNA ("cDNA") is a complementary copy ("clone") of mRNA,
made in the laboratory by reverse transcription of mRNA. Like mRNA, cDNA contains
only the protein-encoding regions of DNA. Thus, once a cDNA's nucleotide sequence
is known, the amino acid sequence of the protein for which it codes may be predicted
using the genetic code relationship between codons and amino acids. The reverse
is not true, however, due to the degeneracy of the code. Many other DNAs may
code for a particular protein. The functional relationships between DNA, mRNA,
cDNA, and a protein may conveniently be expressed as follows:
Image 1 (1" X 4") Available for Offline Print
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Collections ("libraries") of DNA and cDNA molecules derived from various
species may be constructed in the laboratory or obtained from commercial sources.
Complementary DNA libraries contain a mixture of cDNA clones reverse-transcribed
from the mRNAs found in a specific tissue source. Complementary DNA libraries
are tissue-specific because proteins and their corresponding mRNAs are only
made ("expressed") in specific tissues, depending upon the protein.
Genomic DNA ("gDNA") libraries, by contrast, theoretically contain
all of a species' chromosomal DNA. The molecules present in cDNA and DNA libraries
may be of unknown function and chemical structure, and *1555 the proteins which
they encode may be unknown. However, one may attempt to retrieve molecules of
interest from cDNA or gDNA libraries by screening such libraries with a gene
probe, which is a synthetic radiolabelled nucleic acid sequence designed to
bond ("hybridize") with a target complementary base sequence. Such
"gene cloning" techniques thus exploit the fact that the bases in
DNA always hybridize in complementary pairs: adenine bonds with thymine and
guanine bonds with cytosine. A gene probe for potentially isolating DNA or cDNA
encoding a protein may be designed once the protein's amino acid sequence, or
a portion thereof, is known.
As disclosed in Deuel's patent application, Deuel isolated and purified HBGF
from bovine uterine tissue, found that it exhibited mitogenic activity, and
determined the first 25 amino acids of the protein's N-terminal sequence. [FN2]
Deuel then isolated a cDNA molecule encoding bovine uterine HBGF by screening
a bovine uterine cDNA library with an oligonucleotide probe designed using the
experimentally determined N-terminal sequence of the HBGF. Deuel purified and
sequenced the cDNA molecule, which was found to consist of a sequence of 1196
nucleotide base pairs. From the cDNA's nucleotide sequence, Deuel then predicted
the complete amino acid sequence of bovine uterine HBGF disclosed in Deuel's
application.
FN2. Deuel determined that the N-terminal sequence of bovine uterus HBGF is
Gly-Lys-Lys-Glu-Lys-Pro-Glu-Lys-Lys-Val-Lys-Lys-Ser-Asp-Cys-Gly- Glu-Trp-Gln-Trp-Ser-Val-Cys-Val-Pro.
Deuel also isolated a cDNA molecule encoding human placental HBGF by screening
a human placental cDNA library using the isolated bovine uterine cDNA clone
as a probe. Deuel purified and sequenced the human placental cDNA clone, which
was found to consist of a sequence of 961 nucleotide base pairs. From the nucleotide
sequence of the cDNA molecule encoding human placental HBGF, Deuel predicted
the complete amino acid sequence of human placental HBGF disclosed in Deuel's
application. The predicted human placental and bovine uterine HBGFs each have
168 amino acids and calculated molecular weights of 18.9 kD. Of the 168 amino
acids present in the two HBGFs discovered by Deuel, 163 are identical. Deuel's
application does not describe the chemical structure of, or state how to isolate
and purify, any DNA or cDNA molecule except the disclosed human placental and
bovine uterine cDNAs, which are the subject of claims 5 and 7.
Claims 4-7 on appeal are all independent claims and read, in relevant part,
as follows:
4. A purified and isolated DNA sequence consisting of a sequence encoding human
heparin binding growth factor of 168 amino acids having the following amino
acid sequence: Met Gln Ala ... [remainder of 168 amino acid sequence].
5. The purified and isolated cDNA of human heparin-binding growth factor having
the following nucleotide sequence: GTCAAAGGCA ... [remainder of 961 nucleotide
sequence].
6. A purified and isolated DNA sequence consisting of a sequence encoding bovine
heparin binding growth factor of 168 amino acids having the following amino
acid sequence: Met Gln Thr ... [remainder of 168 amino acid sequence].
7. The purified and isolated cDNA of bovine heparin-binding growth factor having
the following nucleotide sequence: GAGTGGAGAG ... [remainder of 1196 nucleotide
sequence].
Claims 4 and 6 generically encompass all isolated/purified DNA sequences (natural
and synthetic) encoding human and bovine HBGFs, despite the fact that Deuel's
application does not describe the chemical structure of, or tell how to obtain,
any DNA or cDNA except the two disclosed cDNA molecules. Because of the redundancy
of the genetic code, claims 4 and 6 each encompass an enormous number of DNA
molecules, including the isolated/purified chromosomal DNAs encoding the human
and bovine proteins. Claims 5 and 7, on the other hand, are directed to the
specifically disclosed cDNA molecules encoding human and bovine HBGFs, respectively.
During prosecution, the examiner rejected claims 4-7 under 35 U.S.C. §
103 as unpatentable over the combined teachings of Bohlen *1556 [ FN3]] and
Maniatis. [FN4] The Bohlen reference discloses a group of protein growth factors
designated as heparin-binding brain mitogens ("HBBMs") useful in treating
burns and promoting the formation, maintenance, and repair of tissue, particularly
neural tissue. Bohlen isolated three such HBBMs from human and bovine brain
tissue. These proteins have respective molecular weights of 15 kD, 16 kD, and
18 kD. Bohlen determined the first 19 amino acids of the proteins' N-terminal
sequences, which were found to be identical for human and bovine HBBMs. [FN5]
Bohlen teaches that HBBMs are brain-specific, and suggests that the proteins
may be homologous between species. The reference provides no teachings concerning
DNA or cDNA coding for HBBMs.
FN3. European Patent Application No. 0326075, naming Peter Bohlen as inventor,
published August 2, 1989.
FN4. Maniatis et al., Molecular Cloning: A Laboratory Manual, "Screening Bacteriophage [lambda] Libraries for Specific DNA Sequences by Recombination in Escherichia coli," Cold Spring Harbor Laboratory, New York, 1982, pp. 353-361.
FN5. Bohlen's disclosed N-terminal sequence for human and bovine HBBMs is Gly-Lys-Lys-Glu-Lys-Pro-Glu-Lys-Lys-Val-Lys-Lys-Ser-Asp-Cys-Gly- Glu-Trp-Gln. This sequence matches the first 19 amino acids of Deuel's disclosed N-terminal sequence.
Maniatis describes a method of isolating DNAs or cDNAs by screening a DNA or
cDNA library with a gene probe. The reference outlines a general technique for
cloning a gene; it does not describe how to isolate a particular DNA or cDNA
molecule. Maniatis does not discuss certain steps necessary to isolate a target
cDNA, e.g., selecting a tissue-specific cDNA library containing a target cDNA
and designing an oligonucleotide probe that will hybridize with the target cDNA.
The examiner asserted that, given Bohlen's disclosure of a heparin-binding protein
and its N-terminal sequence and Maniatis's gene cloning method, it would have
been prima facie obvious to one of ordinary skill in the art at the time of
the invention to clone a gene for HBGF. [FN6] According to the examiner, Bohlen's
published N-terminal sequence would have motivated a person of ordinary skill
in the art to clone such a gene because cloning the gene would allow recombinant
production of HBGF, a useful protein. The examiner reasoned that a person of
ordinary skill in the art could have designed a gene probe based on Bohlen's
disclosed N-terminal sequence, then screened a DNA library in accordance with
Maniatis's gene cloning method to isolate a gene encoding an HBGF. The examiner
did not distinguish between claims 4 and 6 generically directed to all DNA sequences
encoding human and bovine HBGFs and claims 5 and 7 reciting particular cDNAs.
FN6. The examiner and the Board apparently used the term "gene" to
refer both to natural (chromosomal) DNA and synthetic cDNA. We will use the
several terms as appropriate.
In reply, Deuel argued, inter alia, that Bohlen teaches away from the claimed
cDNA molecules because Bohlen suggests that HBBMs are brain-specific and, thus,
a person of ordinary skill in the art would not have tried to isolate corresponding
cDNA clones from human placental and bovine uterine cDNA libraries. The examiner
made the rejection final, however, asserting that
[t]he starting materials are not relevant in this case, because it was well
known in the art at the time the invention was made that proteins, especially
the general class of heparin binding proteins, are highly homologous between
species and tissue type. It would have been entirely obvious to attempt to isolate
a known protein from different tissue types and even different species.
No prior art was cited to support the proposition that it would have been obvious
to screen human placental and bovine uterine cDNA libraries for the claimed
cDNA clones. Presumably, the examiner was relying on Bohlen's suggestion that
HBBMs may be homologous between species, although the examiner did not explain
how homology between species suggests homology between tissue types.
The Board affirmed the examiner's final rejection. In its opening remarks, the
Board noted that it is "constantly advised by the *1557 patent examiners,
who are highly skilled in this art, that cloning procedures are routine in the
art." According to the Board, "the examiners urge that when the sequence
of a protein is placed into the public domain, the gene is also placed into
the public domain because of the routine nature of cloning techniques."
Addressing the rejection at issue, the Board determined that Bohlen's disclosure
of the existence and isolation of HBBM, a functional protein, would also advise
a person of ordinary skill in the art that a gene exists encoding HBBM. The
Board found that a person of ordinary skill in the art would have been motivated
to isolate such a gene because the protein has useful mitogenic properties,
and isolating the gene for HBBM would permit large quantities of the protein
to be produced for study and possible commercial use. Like the examiner, the
Board asserted, without explanation, that HBBMs are the same as HBGFs and that
the genes encoding these proteins are identical. The Board concluded that "the
Bohlen reference would have suggested to those of ordinary skill in this art
that they should make the gene, and the Maniatis reference would have taught
a technique for 'making' the gene with a reasonable expectation of success."
Responding to Deuel's argument that the claimed cDNA clones were isolated from
human placental and bovine uterine cDNA libraries, whereas the combined teachings
of Bohlen and Maniatis would only have suggested screening a brain tissue cDNA
library, the Board stated that "the claims before us are directed to the
product and not the method of isolation. Appellants have not shown that the
claimed DNA was not present in and could not have been readily isolated from
the brain tissue utilized by Bohlen." Deuel now appeals.FN7. Deuel is supported
in its appeal by an amicus curiae brief
submitted by the Biotechnology Industry Organization and the Bay Area Science
Center. Amici urge that, contrary to controlling precedent, the PTO has unlawfully
adopted a per se rule that a gene is prima facie obvious when at least part
of the amino acid sequence of the protein encoded by the gene is known in the
prior art.
DISCUSSION
[1] [2] [3] Obviousness is a question of law, which we review de novo, though
factual findings underlying the Board's obviousness determination are reviewed
for clear error. In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438, 1442 (Fed.Cir.1991);
In re Woodruff, 919 F.2d 1575, 1577, 16 USPQ2d 1934, 1935 (Fed.Cir.1990). The
examiner bears the burden of establishing a prima facie case of obviousness.
In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed.Cir.1993); In
re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed.Cir.1992). Only if
this burden is met does the burden of coming forward with rebuttal argument
or evidence shift to the applicant. Rijckaert, 9 F.3d at 1532, 28 USPQ2d at
1956. When the references cited by the examiner fail to establish a prima facie
case of obviousness, the rejection is improper and will be overturned. In re
Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed.Cir.1988).
[4] On appeal, Deuel challenges the Board's determination that the applied references
establish a prima facie case of obviousness. In response, the PTO maintains
that the claimed invention would have been prima facie obvious over the combined
teachings of Bohlen and Maniatis. Thus, the appeal raises the important question
whether the combination of a prior art reference teaching a method of gene cloning,
together with a reference disclosing a partial amino acid sequence of a protein,
may render DNA and cDNA molecules encoding the protein prima facie obvious under
§ 103.
Deuel argues that the PTO failed to follow the proper legal standard in determining
that the claimed cDNA molecules would have been prima facie obvious despite
the lack of structurally similar compounds in the prior art. Deuel argues that
the PTO has not cited a reference teaching cDNA molecules, but instead has improperly
rejected the claims based on the alleged obviousness of a method of making the
molecules. We agree.
Because Deuel claims new chemical entities in structural terms, a prima facie
case of unpatentability requires that the teachings of the prior art suggest
the claimed compounds to a person of ordinary skill in the art. *1558 Normally
a prima facie case of obviousness is based upon structural similarity, i.e.,
an established structural relationship between a prior art compound and the
claimed compound. Structural relationships may provide the requisite motivation
or suggestion to modify known compounds to obtain new compounds. For example,
a prior art compound may suggest its homologs because homologs often have similar
properties and therefore chemists of ordinary skill would ordinarily contemplate
making them to try to obtain compounds with improved properties. Similarly,
a known compound may suggest its analogs or isomers, either geometric isomers
(cis v. trans) or position isomers (e.g., ortho v. para).
In all of these cases, however, the prior art teaches a specific, structurally-definable
compound and the question becomes whether the prior art would have suggested
making the specific molecular modifications necessary to achieve the claimed
invention. See In re Jones, 958 F.2d 347, 351, 21 USPQ2d 1941, 1944 (Fed.Cir.1992);
In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir.1990) (en banc)
("structural similarity between claimed and prior art subject matter, ...
where the prior art gives reason or motivation to make the claimed compositions,
creates a prima facie case of obviousness"), cert. denied, 500 U.S. 904,
111 S.Ct. 1682, 114 L.Ed.2d 77 (1991); In re Grabiak, 769 F.2d 729, 731-32,
226 USPQ 870, 872 (Fed.Cir.1985) ("[I]n the case before us there must be
adequate support in the prior art for the [prior art] ester/[claimed] thioester
change in structure, in order to complete the PTO's prima facie case and shift
the burden of going forward to the applicant."); In re Lalu, 747 F.2d 703,
705, 223 USPQ 1257, 1258 (Fed.Cir.1984) ("The prior art must provide one
of ordinary skill in the art the motivation to make the proposed molecular modifications
needed to arrive at the claimed compound.").
Here, the prior art does not disclose any relevant cDNA molecules, let alone
close relatives of the specific, structurally-defined cDNA molecules of claims
5 and 7 that might render them obvious. Maniatis suggests an allegedly obvious
process for trying to isolate cDNA molecules, but that, as we will indicate
below, does not fill the gap regarding the subject matter of claims 5 and 7.
Further, while the general idea of the claimed molecules, their function, and
their general chemical nature may have been obvious from Bohlen's teachings,
and the knowledge that some gene existed may have been clear, the precise cDNA
molecules of claims 5 and 7 would not have been obvious over the Bohlen reference
because Bohlen teaches proteins, not the claimed or closely related cDNA molecules.
The redundancy of the genetic code precluded contemplation of or focus on the
specific cDNA molecules of claims 5 and 7. Thus, one could not have conceived
the subject matter of claims 5 and 7 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. What cannot be contemplated or conceived cannot
be obvious.
The PTO's theory that one might have been motivated to try to do what Deuel
in fact accomplished amounts to speculation and an impermissible hindsight reconstruction
of the claimed invention. It also ignores the fact that claims 5 and 7 are limited
to specific compounds, and any motivation that existed was a general one, to
try to obtain a gene that was yet undefined and may have constituted many forms.
A general motivation to search for some gene that exists does not necessarily
make obvious a specifically-defined gene that is subsequently obtained as a
result of that search. More is needed and it is not found here.
[5] The genetic code relationship between proteins and nucleic acids does not
overcome the deficiencies of the cited references. A prior art disclosure of
the amino acid sequence of a protein does not necessarily render particular
DNA molecules encoding the protein obvious because the redundancy of the genetic
code permits one to hypothesize an enormous number of DNA sequences coding for
the protein. No particular one of these DNAs can be obvious unless there is
something in the prior art to lead to the particular DNA and indicate that it
should be *1559 prepared. We recently held in In re Baird, 16 F.3d 380, 29 USPQ2d
1550 (Fed.Cir.1994), that a broad genus does not necessarily render obvious
each compound within its scope. Similarly, knowledge of a protein does not give
one a conception of a particular DNA encoding it. Thus, a fortiori, Bohlen's
disclosure of the N-terminal portion of a protein, which the PTO urges is the
same as HBGF, would not have suggested the particular cDNA molecules defined
by claims 5 and 7. This is so even though one skilled in the art knew that some
DNA, albeit not in purified and isolated form, did exist. The compounds of claims
5 and 7 are specific compounds not suggested by the prior art. A different result
might pertain, however, if there were prior art, e.g., a protein of sufficiently
small size and simplicity, so that lacking redundancy, each possible DNA would
be obvious over the protein. See In re Petering, 301 F.2d 676 (CCPA 1962) (prior
art reference disclosing limited genus of 20 compounds rendered every species
within the genus unpatentable). That is not the case here.
The PTO's focus on known methods for potentially isolating the claimed DNA molecules
is also misplaced because the claims at issue define compounds, not methods.
See In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed.Cir.1993). In Bell,
the PTO asserted a rejection based upon the combination of a primary reference
disclosing a protein (and its complete amino acid sequence) with a secondary
reference describing a general method of gene cloning. We reversed the rejection,
holding in part that "[t]he PTO's focus on Bell's method is misplaced.
Bell does not claim a method. Bell claims compositions, and the issue is the
obviousness of the claimed compositions, not of the method by which they are
made." Id.
[6] [7] [8] We today reaffirm the principle, stated in Bell, that the existence
of a general method of isolating cDNA or DNA molecules is essentially irrelevant
to the question whether the specific molecules themselves would have been obvious,
in the absence of other prior art that suggests the claimed DNAs. A prior art
disclosure of a process reciting a particular compound or obvious variant thereof
as a product of the process is, of course, another matter, raising issues of
anticipation under 35 U.S.C. § 102 as well as obviousness under §
103. Moreover, where there is prior art that suggests a claimed compound, the
existence, or lack thereof, of an enabling process for making that compound
is surely a factor in any patentability determination. See In re Brown, 329
F.2d 1006, 141 USPQ 245 (CCPA 1964) (reversing rejection for lack of an enabling
method of making the claimed compound). There must, however, still be prior
art that suggests the claimed compound in order for a prima facie case of obviousness
to be made out; as we have already indicated, that prior art was lacking here
with respect to claims 5 and 7. Thus, even if, as the examiner stated, the existence
of general cloning techniques, coupled with knowledge of a protein's structure,
might have provided motivation to prepare a cDNA or made it obvious to prepare
a cDNA, that does not necessarily make obvious a particular claimed cDNA. "Obvious
to try" has long been held not to constitute obviousness. In re O'Farrell,
853 F.2d 894, 903, 7 USPQ2d 1673, 1680-81 (Fed.Cir.1988). A general incentive
does not make obvious a particular result, nor does the existence of techniques
by which those efforts can be carried out. Thus, Maniatis's teachings, even
in combination with Bohlen, fail to suggest the claimed invention.
[9] [10] The PTO argues that a compound may be defined by its process of preparation
and therefore that a conceived process for making or isolating it provides a
definition for it and can render it obvious. It cites Amgen Inc. v. Chugai Pharmaceutical
Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed.Cir.), cert. denied, 502 U.S. 856, 112
S.Ct. 169, 116 L.Ed.2d 132 (1991), for that proposition. We disagree. The fact
that one can conceive a general process in advance for preparing an undefined
compound does not mean that a claimed specific compound was precisely envisioned
and therefore obvious. A substance may indeed be defined by its process of preparation.
That occurs, however, when it has already been prepared by that process and
one therefore knows that the result of that process is the stated compound.
The process is part of the definition of the compound. *1560 But that is not
possible in advance, especially when the hypothetical process is only a general
one. Thus, a conceived method of preparing some undefined DNA does not define
it with the precision necessary to render it obvious over the protein it encodes.
We did not state otherwise in Amgen. See Amgen, 927 F.2d at 1206-09, 18 USPQ2d
at 1021-23 (isolated/purified human gene held nonobvious; no conception of gene
without envisioning its precise identity despite conception of general process
of preparation).
We conclude that, because the applied references do not teach or suggest the
claimed cDNA molecules, the final rejection of claims 5 and 7 must be reversed.
See also Bell, 991 F.2d at 784-85, 26 USPQ2d at 1531-32 (human DNA sequences
encoding IGF proteins nonobvious over asserted combination of references showing
gene cloning method and complete amino acid sequences of IGFs).
[11] Claims 4 and 6 are of a different scope than claims 5 and 7. As is conceded
by Deuel, they generically encompass all DNA sequences encoding human and bovine
HBGFs. Written in such a result-oriented form, claims 4 and 6 are thus tantamount
to the general idea of all genes encoding the protein, all solutions to the
problem. Such an idea might have been obvious from the complete amino acid sequence
of the protein, coupled with knowledge of the genetic code, because this information
may have enabled a person of ordinary skill in the art to envision the idea
of, and, perhaps with the aid of a computer, even identify all members of the
claimed genus. The Bohlen reference, however, only discloses a partial amino
acid sequence, and thus it appears that, based on the above analysis, the claimed
genus would not have been obvious over this prior art disclosure. We will therefore
also reverse the final rejection of claims 4 and 6 because neither the Board
nor the patent examiner articulated any separate reasons for holding these claims
unpatentable apart from the grounds discussed above.
One further matter requires comment. Because Deuel's patent application does
not describe how to obtain any DNA except the disclosed cDNA molecules, claims
4 and 6 may be considered to be inadequately supported by the disclosure of
the application. See generally Amgen Inc. v. Chugai Pharmaceutical Co., 927
F.2d 1200, 1212-14, 18 USPQ2d 1016, 1026-28 (Fed.Cir.) (generic DNA sequence
claims held invalid under 35 U.S.C. § 112, first paragraph), cert. denied,
502 U.S. 856, 112 S.Ct. 169, 116 L.Ed.2d 132 (1991); In re Fisher, 427 F.2d
833, 839, 166 USPQ 18, 24 (CCPA 1970) (Section 112 "requires that the scope
of the claims must bear a reasonable correlation to the scope of enablement
provided by the specification to persons of ordinary skill in the art.").
As this issue is not before us, however, we will not address whether claims
4 and 6 satisfy the enablement requirement of § 112, first paragraph, but
will leave to the PTO the question whether any further rejection is appropriate.
We have considered the PTO's remaining arguments and find them not persuasive.
CONCLUSION
The Board's decision affirming the final rejection of claims 4-7 is reversed.
REVERSED