Ex parte Kubin

PRECEDENTIAL OPINION
Pursuant to the Board of Patent Appeals and Interference’s Standard Operating Procedure 2, the opinion
below has been designated a precedential opinion.
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte MAREK Z. KUBIN and RAYMOND G. GOODWIN
____________
Appeal 2007-0819
Application 09/667,859
Technology Center 1600
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Decided: May 31, 2007
____________
Before MICHAEL R. FLEMING, Chief Administrative Patent Judge,
TEDDY S. GRON, TONI R. SCHEINER, ERIC GRIMES, and
NANCY J. LINCK, Administrative Patent Judges.
LINCK, Administrative Patent Judge.
DECISION ON APPEAL
This is a 35 U.S.C. § 134 appeal in the above-referenced case.1
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 The application was filed September 20, 2000. The real party in interest is
Immunex Corporation, a wholly owned subsidiary of Amgen Inc.

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Application 09/667,859
STATEMENT OF THE CASE
The field of the invention is polynucleotides encoding NK (natural
killer) Cell Activation Inducing Ligand (“NAIL”) polypeptides.
( Specification (“Spec.”) 1.) NK cells play a role in the “early, innate
immune system” and “appear to be closely related to T cells.” (Id.) Like T
cells, the immune response of NK cells “involves direct cytotoxicity and
production of various cytokines” that stimulate the immune system. (Id. at
3.)
“NK cells have been implicated as mediators of host defenses against
infection in humans with varicella zoster, herpes simplex, cytomegalovirus,
Epstein-Barr virus, hepatitis B, and hepatitis C viruses.” (Id. at 3.) They
also are “involved in both resistance to and control of cancer spread,”
including leukemia (id. at 3) and “play a . . . role in bone marrow transplant
rejection, as well as solid organ transplant rejection.” (Id. at 4.) Thus,
“depletion of NK cells can result in a decreased resistance to target tissue
infection by viruses.” (Id. at 2.) Finally, “a number of human
lymphoproliferative disorders of NK cells are known.” (Id.) “With the
function of NK cells so important in this variety of physiological responses,
there is a need in the art for methods of controlling NK function.” (Id.)
NAIL is a cell surface marker, or receptor, on the surface of NK cells
that modulates the activity of NK cells. (See id. at 2.) Thus, modulation of
NAIL activity would be expected to modulate NK cell function, thereby
stimulating or inhibiting the immune response.
“CD48 is a membrane glycoprotein found on cells of hematopoietic
origin.” (Id. at 6.) “cDNA clones for CD48 have been isolated” and the
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“nucleotide and amino acid sequences of CD48 are known.” (Id.)
Antibodies to CD48 appear to suppress cell mediated immunity. (Id. at 6-7.)
“The identification of CD48 as a NAIL counter-structure . . . allows the
generation of molecules that can modulate the activation of NK . . . cells.”
(Id. at 45.) Thus, the determination of binding to CD48 potentially provides
a useful tool to identify active variants of NAIL. (See, e.g., claim 73.)
The claimed subject matter is reflected in representative claim 73:2
73. An isolated nucleic acid molecule comprising a polynucleotide
encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ
ID NO:2, wherein the polypeptide binds CD48.
The Examiner has rejected claims 73-78 and 80-89 under 35 U.S.C.
§ 103(a) over the combined teachings of Valiante et al., U.S. Patent No.
5,688,690 (issued Nov. 18, 1997) (“Valiante”); Sambrook et al., Molecular
Cloning: A Laboratory Manual, 2nd Edition, 2.43-2.84 (Cold Spring Harbor,
N.Y. 1989) (“Sambrook”);3 and Porunelloor Mathew et al., Cloning and
Characterization of the 2B4 Gene Encoding a Molecule Associated with
Non-MHC-Restricted Killing Mediated by Activated Natural Killer Cells
and T Cells, 151 J. I MMUNOL ., 5328-5337 (1993) (“Mathew”).4
The Examiner also has rejected claims 73, 74, 80, and 84-89 under
35 U.S.C. § 112, ¶ 1, for lack of enablement and written description.
2 Appellants do not separately argue the claims. Thus, we address each issue
with reference to claim 73.
3 We note Sambrook is incorporated by reference in Valiante (col. 7, ll. 55-
57).
4 This reference is referred to as “Porunelloor” by the Examiner and
Appellants.
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Application 09/667,859
OBVIOUSNESS UNDER § 103(a)
The § 103(a) Issue
The Examiner contends the skilled artisan would have been motivated
to isolate the nucleic acid sequence corresponding to NAIL, based on
Valiante’s disclosure of p38 (which is the same protein as NAIL) and
Valiante’s express teachings how to isolate p38 cDNA by using
conventional techniques, such as taught in Sambrook, including using mAb
C1.7, a probe specific for p38. (Answer 11-16.)
Appellants contend: “As in Deuel, it is not proper for the Office to
use the p38 protein identified in the ‘690 patent [Valiante] together with the
methods such as those described in Sambrook et al. to reject claims drawn to
specific sequences.” (Br. 19 (citing In re Deuel, 51 F.3d 1552, 34 USPQ2d
1210 (Fed. Cir. 1995).)
We frame the § 103(a) issue: Would Appellants’ claimed nucleotide
sequence have been obvious to one of ordinary skill in the art, based on
Valiante’s disclosure of p38 and his express teachings how to isolate its
cDNA by conventional techniques?
Findings of Fact Relating to Obviousness
1. Valiante’s p38 protein is a 38kd molecule recognized by mAb
C1.7, and is the same protein as Appellants’ NAIL, “formerly known as
C1.7.” (Spec. 10: 29-30. See also Answer 14; Spec. 11: 4.)
2. Valiante expressly teaches through a prophetic example how to
“isolat[e] the cDNA clone by using [mAb] C1.7, screening the protein
expression in the cell transfected with the cDNA library and cloning a
corresponding cDNA into a plasmid for sequencing.” (Answer 12 (citing
Valiante, col. 7, l. 48 through col. 8, l. 7 & example 12, cols. 18-19).)
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3. Valiante does not disclose the sequence of p38 recognized by mAb
C1.7 or the DNA encoding p38. (See Valiante passim; Answer 12.)
4. The DNA and protein sequences of p38, and thus NAIL, could
have been obtained by conventional methodologies, such as those taught by
Sambrook. (Valiante, col. 7, l. 48 to col. 8, l. 7; see also Answer 12.)
5. Sambrook is incorporated by reference in Valiante. (Col. 7, ll.
55-57.)
6. Mathews’ cell surface signaling molecule, 2B4, is the mouse
version of Valiante’s p38, the human version. (Answer 15.)
7. Mathews cloned the gene encoding 2B4 and determined its
nucleotide sequence. (Mathews at 5328 (Abstract).)
8. The relevant teachings in Mathews are cumulative to the teachings
in Valiante and Sambrook and merely are exemplary of how routine skill in
the art can be utilized to clone and sequence the cDNA of a similar
polypeptide. (See Answer 15.)
9. Appellants employed conventional methods, “such as those
outlined in Sambrook,” to isolate a cDNA encoding NAIL and determine the
cDNA’s full nucleotide sequence (SEQ NOS: 1 & 3). (Spec. 10: 29 to 13: 7;
Spec. 16: 40 to 17: 1; Spec. 65 (Example 1).)
10. Appellants’ claimed polynucleotide is “isolated from [a] cDNA
library . . . using the commercial monoclonal antibody C1.7 . . . disclosed by
Valiante.” (Answer 13. See also Spec. 65: 17-32.)
11. As acknowledged by Appellants, “the level of skill in the art is
high.” (Br. 11 (citing In re Wands, 858 F.2d 731, 740, 8 USPQ2d 1400,
1404 (Fed. Cir. 1988).)
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12. The state of the art had unquestionably advanced significantly
during the ten year period between the time the Deuel application was filed
in 1990 and Appellants’ application was filed in 2000. See In re Wallach,
378 F.3d 1330, 1333, 71 USPQ2d 1939, 1942 (Fed. Cir. 2004).
13. As acknowledged by Appellants, “methods of making the claimed
nucleic acid sequences . . . are known.” (Br. 11 (citing Wands, 858 F.2d at
740). See also Br. 3 (“isolation of clones is well known in the art”).)
14. Valiante’s disclosure of the polypeptide p38, and a detailed
method of isolating its DNA, including disclosure of a specific probe to do
so, i.e., mAb C1.7, established Valiante’s possession of p38’s amino acid
sequence and provided a reasonable expectation of success in obtaining a
polynucleotide encoding p38, a polynucleotide within the scope of
Appellants’ claim 73. (See Valiante, col. 7, l. 48 to col. 8, l. 7.)
15. As recently clarified by the Federal Circuit, possession of the
cDNA encoding NAIL also provided possession of its nucleic acid sequence,
i.e., “its identity.” In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364,
1368 (Fed. Cir. 2004).
16. One of ordinary skill in the art would have had a reasonable
likelihood of success that he or she would have been able to obtain the
nucleotide encoding NAIL using conventional methods, such as disclosed in
Valiante. (See col. 7, l. 48 to col. 8, l. 33.)
17. NAIL is “a signal transduction surface molecule (p38) expressed
by virtually all human NK cells” and thus plays a role in the immune
response. (Valiante, col. 2, l. 65 to col. 3, l. 40.)
18. Thus, one of ordinary skill in the art would have recognized the
value of isolating NAIL cDNA, and would have been motivated to apply
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Application 09/667,859
conventional methodologies, such as those disclosed in Sambrook and
utilized in Valiante, to do so. (See, e.g.,Valiante, col. 7, l. 48 to col. 8, l. 33.)
See Alza Corp. v. Mylan Labs, 464 F.3d 1286, 1289, 80 USPQ2d 1001,
1003 (Fed. Cir. 2006) (“‘The presence or absence of a motivation to
combine references in an obviousness determination is a pure question of
fact.’ In re Gartside, 203 F.3d 1305, 1316, 53 USPQ2d 1769, 1776 (Fed.
Cir. 2000).”).
Discussion of the § 103(a) Issue
Based on our findings and those of the Examiner, at least one of
Appellants’ claimed polynucleotides would have been obvious to one of
ordinary skill in the art at the time Appellants’ invention was made.
Regardless of some factual similarities between Deuel and this case, Deuel
is not controlling and thus does not stand in the way of our conclusion, given
the increased level of skill in the art and the factual differences. See In re
Wallach, 378 F.3d 1330, 1334, 71 USPQ2d 1939, 1942 (Fed. Cir. 2004)
(“state of the art has developed [since] In re Deuel”).
Appellants argue the “cited references do not provide an adequate
written description of the claimed nucleic acid sequences.” (Reply Br. 18
(citing Noelle v. Lederman, 355 F.3d 1343, 69 USPQ2d 1508 (Fed. Cir.
2004)). In so arguing, Appellants overlook the distinction between
obviousness under § 103 and lack of written description under § 112, § 1.
A single, obvious species within a claimed genus renders the claimed genus
unpatentable under § 103. Thus, an obvious method of obtaining a single
nucleic acid molecule encoding NAIL may be all that is required to show
that the presently claimed genus of nucleic acid molecules is unpatentable
under § 103. In contrast, as discussed infra (see pp. 15-17), the description
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Application 09/667,859
of a single species within a claimed genus may not be sufficient to support
the patentability of the genus under § 112, ¶ 1. See University of California
v. Eli Lilly & Co., 119 F.3d 1559, 1567, 43 USPQ2d 1398, 1405 (Fed. Cir.
1997) (noting the court earlier held “a description which renders obvious a
claimed invention is not sufficient to satisfy the written description
requirement of that invention” and in this case holding disclosure of a
species did not provide adequate written description of a genus). Cf. Eli
Lilly & Co. v. Barr Labs, 251 F.2d 955, 971, 58 USPQ2d 1869, 1880 (Fed.
Cir. 2001) (“later genus claim limitation is anticipated by, and therefore not
patentably distinct from, an earlier species claim”).
With respect to the written description requirement, while “examples
explicitly covering the full scope of the claim language” typically will not be
required, a sufficient number of representative species must be included “to
demonstrate that the patentee possessed the full scope of the [claimed]
invention.” Lizardtech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d
1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005). Thus, Appellants’
argument based on alleged lack of written description in the cited prior art is
unavailing.
Appellants heavily rely on Deuel. (See, e.g., Br. 19.) To the extent
Deuel is considered relevant to this case, we note the Supreme Court
recently cast doubt on the viability of Deuel to the extent the Federal Circuit
rejected an “obvious to try” test. See KSR Int’l Co. v. Teleflex Inc., 127
S.Ct. 1727, ___, 82 USPQ2d 1385, 1394, 1396 (2007) (citing Deuel, 51 F.3d
at 1559). Under KSR, it’s now apparent “obvious to try” may be an
appropriate test in more situations than we previously contemplated.
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Application 09/667,859
When there is motivation
to solve a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her
technical grasp. If this leads to anticipated success, it is
likely the product not of innovation but of ordinary skill and
common sense. In that instance the fact that a combination
was obvious to try might show that it was obvious under
§ 103.
KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, ___, 82 USPQ2d 1385, 1397
(2007). This reasoning is applicable here. 	The “problem” facing those in
the art was to isolate NAIL cDNA, and there were a limited number of
methodologies available to do so. The skilled artisan would have had reason
to try these methodologies with the reasonable expectation that at least one
would be successful. Thus, isolating NAIL cDNA was “the product not of
innovation but of ordinary skill and common sense,” leading us to conclude
NAIL cDNA is not patentable as it would have been obvious to isolate it.
Appellants also argue lack of motivation to combine the cited
references. (Br. 20-22; Reply Br. 19-21.) Motivation to combine references
“may be found in implicit factors, such as ‘knowledge of one of ordinary
skill in the art, and [what] the nature of the problem to be solved as a whole
would have suggested to those of ordinary skill in the art’.” Alza Corp. v.
Mylan Labs., 464 F.3d 1286, 1291, 80 USPQ2d 1001, 1004 (Fed. Cir. 2006)
(quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1337 (Fed. Cir.
2006)). See also KSR, 127 S. Ct. at ___, 82 USPQ2d at 1396 (citing with
approval In re Kahn, 441 F.3d at 988, 78 USPQ2d at 1336).
More specifically, Appellants argue Mathews “teaches that a human
homolog is not expressed,” and thus “a person of skill in the art would not
be motivated to combine” Mathews with Valiante. (Reply Br. 21.)
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Application 09/667,859
Appellants support this argument by quoting from Mathews: “Genomic
Southern blots identified a human homologue of the 2B4 gene. However,
RNA blot analysis of total RNA isolated from human NK cells suggests that
2B4 gene is not expressed in humans.” (Mathews, at 5333, col. 1.)
Rather than teaching away from the combination, as Appellants argue,
this language merely indicates conflicting data existed regarding a 2B4
homolog in humans, with some data pointing to the existence of a human
homolog. (See id.) The quoted language would not have deterred the skilled
artisan from obtaining the cDNA corresponding to Valiante’s p38, as taught
by Valiante, i.e., “from following the path set out in the reference.” In re
Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1131 (Fed. Cir. 1994), quoted
with approval in In re Kahn, 441 F.3d 977, 990, 78 USPQ2d 1329, 1338
(Fed. Cir. 2006). Moreover, Appellants miscomprehend the value of
Mathews. Mathews exemplifies how the cDNA encoding 2B4, the mouse
version of Valiante’s p38 expressed on all NK cells, can be isolated and
sequenced. 	(See Mathews at 5328 (Abstract).) Thus, the teachings of
Mathews, when considered as a whole, support the Examiner’s § 103 ground
of rejection.
PATENTABILITY UNDER § 112, ¶ 1
The Enablement Issue
The Examiner found lack of enablement due to the “at least 80%
identity language,” in the absence of any working examples, other than SEQ
ID NOS:1 and 2. He cites examples in the literature in which very small
changes in sequence, even one amino acid, yield a different function.
(Answer 3-6.)
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Application 09/667,859
Appellants respond: “The Office’s reasoning ignores the many
references that positively demonstrate that proteins can be mutated and
maintain a biological function.” (Reply Br. 4 (citing numerous publications
in support).) Moreover, “the specification provides extensive guidance for
creating and screening mutants” (Reply Br. 5) in that it “teaches in detail
how to: 1) make variants of SEQ ID NOs: 1 and 2; 2) calculate the percent
identity between SEQ ID NOs: 1 and 2 and the variant sequence; and 3) test
the variant sequence to determine if it binds to CD48” (Br. 11; Reply Br. 6).
Thus, according to Appellants, only routine experimentation would be
required to practice the claimed invention. (Reply Br. 9.)
In view of these conflicting positions, we frame the enablement issue
as follows: Considering the relevant Wands factors, including the prior art
teachings cited by the Examiner and Appellants to establish the level of
predictability in the relevant art, would undue experimentation have been
required to practice the full scope of claim 73?
The Written Description Issue
The Examiner bases his written description rejection on the same
claim language as the enablement rejection, i.e., “at least 80% identity,” and
finds Appellants’ disclosed sequences inadequate to show “possession of”
their claimed genus. (Answer 9 (citing University of California v. Eli Lilly
& Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997).)
In response, Appellants contend (1) Lilly can be distinguished on its
facts and (2) the Examiner’s position is inconsistent with Example 14 in the
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Office’s “Synopsis of Application of Written Description Guidelines”5
(hereafter “Synopsis”) (www.uspto.gov/web/patents/guides.htm), an
example which contains “analysis of [a] claim that is highly similar to the
claims at issue.” (Reply Br. 13.)
In view of the above, we frame the written description issue: 	Does
Appellants’ Specification contain a written description sufficient to show
they had possession of the full scope of their claimed invention at the time
the application was filed, as required by Federal Circuit precedent?
Findings of Fact Relating to § 112, ¶ 1
19. Claim 73 is limited to isolated polynucleotides encoding
polypeptides (1) which are “at least 80% identical to amino acids 22-221 of
SEQ ID NO:2” (the amino acid sequence for the extracellular domain of
NAIL without the signal sequence), and (2) which bind CD48. (See claim
73; Spec. 13: 9-18.)
20. The Specification provides two working examples within the
scope of claim 73, i.e., a DNA encoding NAIL (SEQ ID NO: 1) and NAIL’s
coding sequence with accompanying upstream and downstream noncoding
sequences (SEQ ID NO: 3). SEQ ID NOs: 1 and 3 both encode the amino
acid sequence of SEQ ID NO: 2. (Spec. 10: 29 to 13: 7; Spec. 16: 40 to 17:
1; Spec. 65 (Example 1).)
21. The Specification also discloses the amino acid sequences for
three fusion proteins (SEQ ID NOs: 6, 7, & 8) whose nucleotide sequences
would fall within the scope of claim 73. (Spec. 25: 30 to 33: 9.)
5 Guidelines for Examination of Patent Applications Under the 35 U.S.C.
112, ¶ 1 “Written Description” Requirement, 66 Fed. Reg. 1099 (Jan.5,
2001) (“Written Description Guidelines”).
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22. The Specification does not disclose any variants in which the
nucleotide sequence encoding amino acids 22-221 of SEQ ID NO:2 is
varied. (Spec. passim.)
23. Thus, the Specification does not disclose “which 20% . . . of
amino acid residues should be changed in order to maintain the biological
functions for binding to CD48.” (Answer 5.)
24. The Specification “teaches in detail how to: 1) make variants of
SEQ ID NOs: 1 and 2; 2) calculate the percent identity between SEQ ID
NOs: 1 and 2 and the variant sequence; and 3) test the variant sequence to
determine if it binds to CD48.” (Br. 11; Reply Br. 6.)
25. The Specification does not disclose a correlation between
function (binding to CD48) and structure responsible for binding to CD48
(other than the entire extracellular domain) such that the skilled artisan
would have known what modifications could be made of the very large
number of modifications potentially encompassed by claim 73 without
losing function. (See Spec. passim; Answer 10.)
26. At the time Appellants’ application was filed, molecular biology
was generally an unpredictable art, as evidenced by the references cited by
the Examiner. (Answer 4 (citing Robin E. Callard & Andy J.H. Gearing,
The Cytokine FactsBook 188-89 (Academic Press 1994); Struyf et al.,
Natural truncation of RANTES abolishes signaling through the CC
chemokine receptors CCR1 and CCR3, impairs its chemotactic potency and
generates a CC chemokine inhibitor, 28 Eur. J. Immunol. 1262-71 (1998); &
Proudfoot et al., U.S. Patent 6,159,711 (Dec. 12, 2000).)
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27. At the time Appellants’ application was filed, the level of skill in
the relevant art (molecular biology) was high, as acknowledged by
Appellants. (Br. 11.)
28. “[M]ethods of making the claimed nucleic acid sequences and
screening for activity [were] known in the art and described in the
specification.” (Br. 11-12.)
29. The “experimentation involved to produce other sequences within
the scope of the claims” and thus to practice the full scope of claim 73,
would have been “well within the skill of those in the art” (Br. 12) and thus
would have been routine.
30. One of ordinary skill in the art would not have been required to
perform undue experimentation to practice the invention of claim 73.
Discussion of the Enablement Issue
In making the above findings, we have considered the relevant Wands
factors in light of the prior art teachings relied upon by the Examiner and
Appellants, and the relevant caselaw. We agree with the Examiner that
molecular biology is generally an unpredictable art (and thus was so at the
time the application was filed). However, with respect to enablement, the
other Wands factors weigh in Appellants’ favor, particularly “the state of the
art” and “the relative skill of those in the art,” In re Wands, 858 F.2d 731,
736, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), as evidenced by the prior art
teachings and Appellants’ Specification.
The amount of experimentation to practice the full scope of the
claimed invention might have been extensive, but it would have been
routine. The techniques necessary to do so were well known to those skilled
in the art. See, e.g., Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342,
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1360, 47 USPQ2d 1705, 1719 (Fed. Cir. 1998) (“test [for undue
experimentation] is not merely quantitative . . . if it is merely routine”). 	A
“patent need not teach, and preferably omits, what is well known in the art.”
Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231
USPQ 81, 94 (Fed. Cir. 1986). Thus, we conclude the Specification would
have enabled the full scope of claim 73.
Discussion of the Written Description Issue
In spite of concluding claim 73 would have been enabled, Federal
Circuit caselaw compels us to find the written description requirement is not
met. 	See generally, e.g., University of Rochester v. G.D. Searle & Co., 358
F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004); Enzo Biochem. Inc. v. Gen-
Probe Inc., 323 F.3d 956, 63 USPQ2d 1609 (Fed. Cir. 2002); University of
California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir.
1997); Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993).
“Although there is often significant overlap” between the enablement
and written description requirements, “they are nonetheless independent of
each other.” University of Rochester, 358 F.3d at 921, 69 USPQ2d at 1891.
An “invention may be enabled even though it has not been described.” Id.
Such is the situation here. While we conclude one skilled in the art would
have been able to make and use the full scope of claim 73 through routine
experimentation, we find Appellants did not describe the invention of claim
73 sufficiently to show they had possession of the claimed genus of nucleic
acids. See, e.g., Noelle v. Lederman, 355 F.3d 1343, 1348, 69 USPQ2d
1508, 1513 (Fed. Cir. 2004) (“invention is, for purposes of the ‘written
description’ inquiry, whatever is now claimed”).
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Claim 73 is to a genus of polynucleotides encoding polypeptides “at
least 80% identical to amino acids 22-221 of SEQ ID NO:2” which bind to
CD48. Sufficient description to show possession of such a genus “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 members of the genus, which
features constitute a substantial portion of the genus.” Eli Lilly, 119 F.3d at
1568, 43 USPQ2d at 1406. Possession may not be shown by merely
describing how to obtain possession of members of the claimed genus or
how to identify their common structural features. See University of
Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
In this case, Appellants have sequenced two nucleic acids falling
within the scope of claim 73 and three fusion proteins whose nucleotide
sequences would fall within the scope of claim 73. None of these sequences
varies amino acids 22-221 of NAIL, and thus these sequences are not
representative of the genus.
Appellants also have described how to make and test other sequences
within claim 73 sufficiently to satisfy the enablement requirement.
However, they have not described what domains of those sequences are
correlated with the required binding to CD48, and thus have not described
which of NAIL’s amino acids can be varied and still maintain binding.
Thus, under Lilly and its progeny, their Specification would not have shown
possession of a sufficient number of sequences falling within their
potentially large genus to establish possession of their claimed genus. Cf.
Enzo, 323 F.3d at 964, 63 USPQ2d at 1612 (“if the functional characteristic
of . . . binding to [CD48] were coupled with a disclosed correlation between
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that function and a structure that is sufficiently known or disclosed,” the
written description requirement may be met).
Without a correlation between structure and function, the claim does
little more than define the claimed invention by function. That is not
sufficient to satisfy the written description requirement. See Eli Lilly, 119
F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not
suffice to define the genus because it is only an indication of what the gene
does, rather than what it is”).
With respect to Appellants’ reliance on hypothetical Example 14 in
the Office’s Synopsis, “[c]ompliance with the written description
requirement is essentially a fact-based inquiry that will ‘necessarily vary
depending on the nature of the invention claimed.’” Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991)
(quoting In re DiLeone, 436 F.2d 1404, 1405, 168 USPQ 592, 593 (CCPA
1971)), quoted with approval in Enzo, 323 F.3d at 963, 63 USPQ2d at 1612.
While the Written Description Guidelines and the hypothetical examples in
the Office’s Synopsis can be helpful in understanding how to apply the
relevant law (as it existed in 2001 when the Guidelines were adopted), they
do not create a rigid test.
Based on the above, we find the written description requirement of
§ 112, ¶ 1, is not met.
CONCLUSION
In summary, with respect to claim 73, we affirm the § 103(a)
rejection, reverse the § 112, ¶ 1, enablement rejection, and affirm the § 112,
¶ 1, written description rejection.
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Pursuant to § 41.37(c)(1)(vii)(2006), we also affirm the rejection of
claims 74-78 and 80-89 under § 103(a); reverse the § 112, ¶ 1, enablement
rejection of claims 74, 80, and 84-89; and affirm the § 112, ¶ 1, written
description rejection of claims 74, 80, and 84-89, as these claims were not
argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED
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IMMUNEX CORPORATION
LAW DEPARTMENT
1201 AMGEN COURT WEST
SEATTLE WA 98119
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