Lundak, In re

Decision Date16 September 1985
Docket NumberNo. 85-887,85-887
Citation227 USPQ 90,773 F.2d 1216
PartiesIn re Robert L. LUNDAK. Appeal
CourtU.S. Court of Appeals — Federal Circuit

Bertram I. Rowland, Townsend & Townsend, San Francisco, Cal., argued for appellant.

Harris A. Pitlick, Associate Sol., U.S. Patent & Trademark Office, Arlington, Va., argued for appellee. With him on the brief were Joseph F. Nakamura, Sol. and John W. Dewhirst, Associate Sol., Washington, D.C.

Before MARKEY, Chief Judge, BENNETT, and NEWMAN, Circuit Judges.

PAULINE NEWMAN, Circuit Judge.

This appeal concerns the administrative rule of the United States Patent and Trademark Office (PTO) whereby an inventor in the field of microbiology is required to deposit a sample of relevant biological materials with an independent depository on or before the date the inventor files a patent application. Such deposit requirement applies only to biological materials that are not readily reproducible from their written description.

The PTO Board of Appeals affirmed the examiner's rejection of claims 1 and 2 of patent application Serial No. 247,656 entitled "High Fusion Frequency Fusible Lymphoblastoid Cell Line", invention of Robert L. Lundak, for failure to meet the requirements of 35 U.S.C. Sec. 112, first paragraph, due to Lundak's failure to make such deposit on or before his filing date. A deposit seven days after the filing date was held not to cure the deficiency. The PTO also refused to change Lundak's filing date to the date of the deposit.

Background

The appealed claims are directed to a new human cell line and the hybridomas resulting from its fusion with lymphoid cells. These hybridomas are useful to secrete immunoglobulins derived from the cell line, in turn useful for diagnostic and therapeutic purposes. Claims 1 and 2 are as follows:

1. An immortal B-cell line WI-L2-729HF 2 .

2. A hybridoma resulting from the fusion of an immunized lymphocyte and a cell line according to Claim 1.

The new cell line was developed by mutagenesis and selection from a known cell line, by procedures that fill twelve pages of Lundak's specification, and include experimental details such as the following:

EXPERIMENTAL

A HAT-medium sensitive mutant cell line was obtained by subjecting the known human lymphoblastoid B-cell line WI-L2 to increasing concentrations of 6-thioguanine and isolating mutants resistant to 6-thioguanine. A thioguanine-resistant clone was isolated and designated UC 729-6. The UC 729-6 cells are routinely grown in RPMI 1640 media supplemented with 10% FCS, 2mM glutamine and 10 -4M 6-thioguanine. UC 729-6 doubles in concentration every 17 hours.

The above cells were then grown at very high densities, approximately 1-1.5 X 11 7 [sic] cell/ml and at this high confluent density, the cells were shifted slowly into ever-decreasing concentrations of fetal calf serum. The concentration of fetal calf serum was decreased by 2% each week from the original 15% and the cells were seeded at high densities i.e. 5 X 10 6 cells per transfer. Following four months of successive transfers, the cells grew on 2% FCS in Iscove's synthetic medium (Iscove and Melchers, supra ), but not in Iscove's synthetic medium by itself.

Iscove's media was conditioned with growing mouse peritoneal fibroblasts in the presence of about 10ug insulin. Monolayers of mouse fibroblasts in their second or third doubling (in some cases as much as five doublings, but not greater), were incubated with Iscove's synthetic media for 24 hours. This conditioned media was then used 50-50 with normal Iscove's media to shift the modified 729 cells into serum-free conditions. Out of about 50 flasks of cells, one flask developed qualities that would grow in Iscove's serum-free media and that cell line was continued. These cells showed no improvement in fusion frequency.

These cells were cloned out to limiting dilutions so that each population was an expansion of a single cell. Each of these populations (approximately 900) were grown into colonies of approximately 5 X 10 7 cells and these cells were fused with human lymphocytes in a procedure using polyethylene glycol 1000 elevated to pH8.2 and containing 15% dimethylsulfoxide and incubated at 27?C for 8.5 minutes. [and so on]

Because of the uncertainties of reproducibility that inhere in such processes, at least in the present state of biotechnology, this invention is of the class covered by the deposit requirement. Robert Lundak, a professor at the University of California, filed an application for patent on March 26, 1981, apparently in the belief that samples of his new cell line had been deposited with the American Type Culture Collection (ATCC), a recognized depository for biological materials. However, this deposit was not made until April 2, 1981.

The examiner cited no prior art, but rejected Lundak's claims under 35 U.S.C. Sec. 112, first paragraph, as nonenabling for failure to meet the criteria of Manual of Patent Examining Procedure (MPEP) Sec. 608.01(p)C, as follows:

C. DEPOSIT OF MICROORGANISMS

Some inventions which are the subject of patent applications depend on the use of microorganisms which must be described in the specification in accordance with 35 U.S.C. 112. No problem exists when the microorganisms used are known and readily available to the public. When the invention depends on the use of a microorganism which is not so known and readily available, applicants must take additional steps to comply with the requirements of Sec. 112.

In re Argoudelis, et al., 168 USPQ 99 (CCPA, 1970), accepted a procedure for meeting the requirements of 35 U.S.C. 112. Accordingly, the Patent and Trademark Office will accept the following as complying with the requirements of Sec. 112 for an adequate disclosure of the microorganism required to carry out the invention:

(1) the applicant, no later than the effective U.S. filing date of the application, has made a deposit of a culture of the microorganism in a depository affording permanence of the deposit and ready accesibility [sic] thereto by the public if a patent is granted, under conditions which assure (a) that access to the culture will be available during pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and (b) that all restrictions on the availability to the public of the culture so deposited will be irrevocably removed upon the granting of the patent;

(2) such deposit is referred to in the body of the specification as filed and is identified by deposit number, name and address of the depository, and the taxonomic description to the extent available is included in the specification; and

(3) the applicant or his assigns has provided assurance of permanent availability of the culture to the public through a depository meeting the requirements of (1). Such assurance may be in the form of an averment under oath or by declaration by the applicant to this effect.

A copy of the applicant's contract with the depository may be required by the examiner to be made of record as evidence of making the culture available under the conditions stated above.

In exchanges between Lundak and the ATCC, and Lundak and the examiner, Lundak eventually established to the examiner's satisfaction that the deposit would be maintained for at least thirty years, for which the entire fee was required (by ATCC as well as by the PTO) to be paid in advance, and that the deposit would be replaced by Lundak as necessary to assure its viability. The criteria of MPEP Sec. 608.01(p)C were then deemed satisfied except for the unalterable fact that the deposit had been made seven days after the patent application was filed.

Lundak sought relief first by petition to the Commissioner, to change his filing date from March 26, 1981 to April 2, 1981. The Commissioner denied the petition, stating that there was no indication that the application was not complete as of March 26, 1981 "for the purposes of having a filing date accorded thereto".

Lundak duly appealed the examiner's rejection under section 112 to the Board of Appeals, arguing inter alia that he had deposited the cell line with colleagues at the University of California and elsewhere. Sitting in an expanded panel, the Board affirmed the rejection. In its opinion, joined by twelve of the eighteen members of the panel, the Board held that Lundak's deposit of the cell line at university laboratories was inadequate to meet the legal requirements because they were not "recognized depositories" which could guarantee permanent availability. The Board also stated that such deposit would not meet the terms of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, April 28, 1977, 32 U.S.T. 1241, T.I.A.S. No. 9768, to which the United States is a signatory, because inter alia the academic institutions had not agreed to maintain the cultures for the required period.

The Board also held 1 that Lundak's deposit made with the ATCC after his filing date could not overcome the section 112 rejection because this deposit was "new matter", proscribed by 35 U.S.C. Sec. 132.

The Board's opinion was accompanied by two concurring opinions. Four Board members affirmed the rejection on the ground that Lundak had failed to overcome a prima facie case of non-enablement. In their view a failure to deposit the biological material with an independent depository on or before the filing date should not be fatal, since this is not the sole means by which evidence of enablement can be presented. They would have allowed Lundak to present additional evidence of the existence of this cell line at the time of his filing date, to overcome the rejection under section 112.

Two other concurring Board members observed that based on Feldman v. Aunstrup, 517 F.2d 1351, 186 USPQ 108 (CCPA 1975), cert. denied, 424 U.S. 912, 96 S.Ct. 1109, 47 L.Ed.2d 316, 188 USPQ...

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