In Re David Wallach, Hartmut Engelmann, Dan Aderka, Daniela Novick and Menachem Rubinstein
David Wallach, Hartmut Engelmann, Dan Aderka, Daniela Novick, and Mena-chem Rubinstein (collectively, “Appellants”) appeal from the decision of the United States Patent and Trademark Office (“PTO”) Board of Patent Appeals and Interferences affirming the rejection of claims 11-13, 35-38, 43, 44, 46-49, 51-54, 56-61, 63, and 64 of United States patent application 08/485,129 under the written description requirement of
BACKGROUND
In the 1980s, Appellants apparently discovered two specific proteins isolated from human urine that, among other things, selectively inhibit the cytotoxic effect of tumor necrosis factor (“TNF”). They named the compounds TNF binding proteins I
&
II (“TBP-I” and “TBP-II”). After obtaining a partial amino acid sequence of the N-terminal portion of TBP-II and determining that the complete protein has a molecular weight of about 30 kilodaltons (“kDa”) when measured by sodium dodecyl sulfate polyacrylamide gel electrophoresis (“SDS-PAGE”) under reducing conditions, Appellants filed a patent application including,
inter alia,
claims directed to proteins having that molecular weight and partial sequence (ie., threonin e-proline-tyrosine-alanine-proline-glutamic acid-proline-gly-cine-serine-threonine, or “Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr”) and having the ability to inhibit the cytotoxic effect of TNF. Appellants’ application also in-
Citing this court’s decisions in
Amgen, Inc. v. Chugai Pharmaceutical Co.,
Appellants now appeal. We have jurisdiction pursuant to
DISCUSSION
Claim 11 of the '129 application reads as follows:
11. An isolated DNA molecule comprising a contiguous nucleotide sequence coding for a protein consisting of naturally occurring human Tumor Necrosis Factor (TNF) Binding Protein II, herein designated TBP-II, said TBP-II including the amino acid sequence: Thr-Pro-Tyr-AIa-Pro-Glu-Pro-Gly-Ser-Thr in the portion of the protein sequenced by N-terminal sequence analysis, said protein having the ability to inhibit the cytotoxic effect of TNF, wherein said naturally occurring TBP-II protein is the same as that protein having the ability to inhibit the cytоtoxic effect of TNF which, after being purified by subjecting a crude protein recovered from a dia-lyzed concentrate of human urine to affinity chromatography on a column of immobilized TNF, elutes from a reversed-phase high pressure liquid chromatography column as a single peak in a fraction corresponding to about 31% ace-tonitrile and shows a molecular weight of about 30 kDa when measured by SDS-PAGE under reducing conditions.
On appeal, Appellants argue that the PTO has effectively conceded that the TBP-II protein, which the claimed isolated DNA encodes, is sufficiently described in the specification tо comply with
Appellants also argue that this case is distinguishable from past written description cases such as
Amgen v. Chugai
and
Fiers,
because Appellants have provided an actual amino acid sequence that is encoded by the claimed DNA, not simply the name of the protein and a statement that the DNA can be obtained by reverse transcription. Appellants contend that this easе is also distinguishable from
Lilly
because the inventors here are not attempting to claim DNA molecules encoding a plurality of unknown proteins from various species having no common features, but only those encoding the single protein sequence that is actually set forth in the specification. Finally, Appellants argue that, because there is a known correlation between the function (ie., encoding a specified amino acid sequence) and structure, this is the quintessential example of the sort of functional description permitted by
The PTO responds by arguing that Appellants’ specification includes neither any аctual DNA sequence within the scope of the claims nor the complete amino acid sequence of the TBP-II protein, but only the sequence of ten out of the 185-192 amino acids that make up the protein. Furthermore, the PTO argues, the only disclosed function of the claimed DNA molecules is to encode the TBP-II protein, and no information is provided from which the claimed DNA molecules can be distinguished from other DNA molecules. According to the PTO, the identity of the nucleic acid encoding a protein is not an inherent property of the protein. If Appellants’ reasoning were accepted, the PTO asserts, the rеsult would be that the disclosure of an isolated protein would be prior art under § 102 with respect to claims directed to any nucleic acid encoding the protein. Finally, the PTO contends, substantial evidence supports the Board’s factual finding that Appellants’ specification does not adequately describе the claimed genus of DNA molecules.
As a preliminary matter, we agree with Appellants that the state of the art has developed such that the complete amino acid sequence of a protein may put one in possession of the genus of DNA sequences encoding it, and that one of ordinary skill in the art at the time the '129 application was filed may have therefore been in possession of the entire genus of DNA sequences that can encode the disclosed partial protein sequence, even if individual species within that genus might not have been described or rendered obvious.
Cf. In re Deuel,
Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide - an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an appliсant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species.
MPEP § 2163.II.A.3.a.ii. (8th ed., rev. 2 2001).
Moreover, we see no reason to require a patent applicant to list every possible permutation of the nucleic acid sequencеs that can encode a particular protein for which the amino acid sequence is disclosed, given the fact that it is, as explained above, a routine matter to convert back and forth between an amino acid sequence and the sequences of the nucleic acid molecules that сan encode it.
Nonetheless, Appellants did not claim the nucleic acid molecules that encode the simple protein sequence that they disclosed. Rather, they claimed the nucleic acids encoding a protein for which they provided only a partial sequence. Appellants cоncede that it is now known that urinary TBP-II has a sequence of 185-192 amino acids. Without the approximately 95% of the amino acid sequence that Appellants did not disclose, we cannot say that the DNA molecules claimed in the '129 application have been described. As the MPEP explains, “disclosure of a partiаl structure without additional characterization of the product may not be sufficient to evidence possession of the claimed invention.” MPEP § 2163.II.A.3.a.i. The Board's decision was thus consistent with its guidance in the MPEP. Here, Appellants disclosed a partial structure and possibly sufficient additional characterization of the TBP-II protein to satisfy the PTO that they were in possession of the claimed subject matter in their '443 application, but that additional characterization contributes little, if anything, to the description of the DNA molecules claimed in the '129 application.
Appellants argue that “[a]s appellants have demonstrated possession of the TBP-II protein, appellants were also necessarily in possession of its inherent amino acid sequence, as well as all of the DNA sequences encoding that amino acid sequence.” We disagree. Whether Appellants were in possession of the protein says nothing about whether they were in possession of the protein’s amino acid sequence. Although Appellants correctly point out that a protein’s amino acid sequence is an inherent property of the protein, the fact that Appellants may have isolated and thus physically possessed
A gene is a chemical compound, albeit a complex one, and it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it. Conception does not occur unless one has a mental picture of the structure of the chemical, or is able to define it by its method of preparation, its physiсal or chemical properties, or whatever characteristics sufficiently distinguish it. It is not sufficient to define it solely by its principal biological property, ... because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological proрerty-
As Appellants point out, we have recognized that the written description requirement can in some cases be satisfied by functional description.
See, e.g., Enzo,
the written description requirement can be met by “showing] that an invention is complete by disclosure of sufficiently detailed, rеlevant identifying characteristics ... i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Guidelines, 66 Fed.Reg. at 1106 (emphasis added).
Enzo,
CONCLUSION
The Board correctly аffirmed the examiner’s determination that the specification of the '129 application does not provide an adequate written description of the pend
AFFIRMED.
Notes
. The Board treated all of the appealed claims as standing or falling together with claim 11, pursuant to