Vaeck, In re

Decision Date21 October 1991
Docket NumberNo. 91-1120,91-1120
Citation20 USPQ2d 1438,947 F.2d 488
PartiesIn re Mark A. VAECK, Wipa Chungjatupornchai and Lee McIntosh.
CourtU.S. Court of Appeals — Federal Circuit

Ian C. McLeod, Ian C. McLeod, P.C., Okemos, Mich., argued for appellant.

Teddy S. Gron, Associate Sol., Office of the Sol., of Arlington, Va., argued for appellee. With him on the brief were Fred E. McKelvey, Sol. and Richard E. Schafer, Associate Sol.

Before RICH, ARCHER, and MAYER, Circuit Judges.

RICH, Circuit Judge.

This appeal is from the September 12, 1990 decision of the Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board), affirming the examiner's rejection of claims 1-48 and 50-52 of application Serial No. 07/021,405, filed March 4, 1987, titled "Hybrid Genes Incorporating a DNA Fragment Containing a Gene Coding for an Insecticidal Protein, Plasmids, Transformed Cyanobacteria Expressing Such Protein and Method for Use as a Biocontrol Agent" as unpatentable under 35 U.S.C. § 103, as well as the rejection of claims 1-48 and 50-51 under 35 U.S.C. § 112, first paragraph, for lack of enablement. We reverse the § 103 rejection. The § 112 rejection is affirmed in part and reversed in part.

BACKGROUND
A. The Invention

The claimed invention is directed to the use of genetic engineering techniques 1 for production of proteins that are toxic to insects such as larvae of mosquitos and black flies. These swamp-dwelling pests are the source of numerous human health problems, including malaria. It is known that certain species of the naturally-occurring Bacillus genus of bacteria produce proteins ("endotoxins") that are toxic to these insects. Prior art methods of combatting the insects involved spreading or spraying crystalline spores of the insecticidal Bacillus proteins over swamps. The spores were environmentally unstable, however, and would often sink to the bottom of a swamp before being consumed, thus rendering this method prohibitively expensive. Hence the need for a lower-cost method of producing the insecticidal Bacillus proteins in high volume, with application in a more stable vehicle.

As described by appellants, the claimed subject matter meets this need by providing for the production of the insecticidal Bacillus proteins within host cyanobacteria. Although both cyanobacteria and bacteria are members of the procaryote 2 kingdom, the cyanobacteria (which in the past have been referred to as "blue-green algae") are unique among procaryotes in that the cyanobacteria are capable of oxygenic photosynthesis. The cyanobacteria grow on top of swamps where they are consumed by mosquitos and black flies. Thus, when Bacillus proteins are produced within More particularly, the subject matter of the application on appeal includes a chimeric (i.e., hybrid) gene comprising (1) a gene derived from a bacterium of the Bacillus genus whose product is an insecticidal protein, united with (2) a DNA promoter effective for expressing 4 the Bacillus gene in a host cyanobacterium, so as to produce the desired insecticidal protein.

transformed 3 cyanobacterial hosts according to the claimed invention, the presence of the insecticide in the food of the targeted insects advantageously guarantees direct uptake by the insects.

The claims on appeal are 1-48 and 50-52, all claims remaining in the application. Claim 1 reads:

1. A chimeric gene capable of being expressed in Cyanobacteria cells comprising:

(a) a DNA fragment comprising a promoter region which is effective for expression of a DNA fragment in a Cyanobacterium; and

(b) at least one DNA fragment coding for an insecticidally active protein produced by a Bacillus strain, or coding for an insecticidally active truncated form of the above protein or coding for a protein having substantial sequence homology to the active protein,

the DNA fragments being linked so that the gene is expressed.

Claims 2-15, which depend from claim 1, recite preferred Bacillus species, promoters, and selectable markers. 5 Independent claim 16 and claims 17-31 which depend therefrom are directed to a hybrid plasmid vector which includes the chimeric gene of claim 1. Claim 32 recites a bacterial strain. Independent claim 33 and claims 34-48 which depend therefrom recite a cyanobacterium which expresses the chimeric gene of claim 1. Claims 50-51 recite an insecticidal composition. Claim 52 recites a particular plasmid that appellants have deposited.

B. Appellants' Disclosure

In addition to describing the claimed invention in generic terms, appellants' specification discloses two particular species of Bacillus (B. thuringiensis, B. sphaericus ) as sources of insecticidal protein; and nine genera of cyanobacteria (Synechocystis, Anacystis, Synechococcus, Agmenellum, Aphanocapsa, Gloecapsa, Nostoc, Anabaena and Ffremyllia ) as useful hosts.

The working examples relevant to the claims on appeal detail the transformation of a single strain of cyanobacteria, i.e., Synechocystis 6803. In one example, Synechocystis 6803 cells are transformed with a plasmid comprising (1) a gene encoding a particular insecticidal protein ("B.t. 8") from Bacillus thuringiensis var. israelensis, linked to (2) a particular promoter, the P subL promoter from the bacteriophage Lambda (a virus of E. coli ). In another example, a different promoter, i.e., the Synechocystis 6803 promoter for the rubisco operon, is utilized instead of the Lambda P subL promoter.

C. The Prior Art

A total of eleven prior art references were cited and applied, in various combinations, against the claims on appeal.

The focus of Dzelzkalns, 6 the primary reference cited against all of the rejected claims, is to determine whether chloroplast promoter sequences can function in cyanobacteria. To that end Dzelzkalns discloses the expression in cyanobacteria of a chimeric gene comprising a chloroplast promoter Sekar I, 8 Sekar II, 9 and Ganesan 10 collectively disclose expression of genes encoding certain Bacillus insecticidal proteins in the bacterial hosts B. megaterium, B. subtilis and E. coli.

                sequence fused to a gene encoding the enzyme chloramphenicol acetyl transferase (CAT). 7  Importantly, Dzelzkalns teaches the use of the CAT gene as a "marker" gene;  this use of antibiotic resistance-conferring genes for selection purposes is a common technique in genetic engineering
                

Friedberg 11 discloses the transformation of the cyanobacterium Anacystis nidulans R2 by a plasmid vector comprising the O subL P subL operator-promoter region and a temperature-sensitive repressor gene of the bacteriophage Lambda. While the cyanobacteria are attractive organisms for the cloning of genes involved in photosynthesis, Friedberg states, problems may still be encountered such as suboptimal expression of the cloned gene, detrimental effects on cell growth of overexpressed, highly hydrophobic proteins, and rapid turnover of some gene products. To address these problems, Friedberg teaches the use of the disclosed Lambda regulatory signals in plasmid vehicles which, it states, have "considerable potential for use as vectors the expression of which can be controlled in Anacystis...."

Miller 12 compares the initiation specificities in vitro of DNA-dependent RNA polymerases 13 purified from two different species of cyanobacteria (Fremyella diplosiphon and Anacystis nidulans ), as well as from E. coli.

Nierzwicki-Bauer 14 identifies in the cyanobacterium Anabaena 7120 the start site for transcription of the gene encoding rbcL, the large subunit of the enzyme ribulose-1,5-bisphosphate carboxylase. It reports that the nucleotide sequence 14-8 base pairs preceding the transcription start site "resembles a good Escherichia coli promoter," but that the sequence 35 base pairs before the start site does not.

Chauvat 15 discloses host-vector systems for gene cloning in the cyanobacterium Synechocystis 6803, in which the antibiotic resistance-conferring neo gene is utilized as a selectable marker.

Reiss 16 studies expression in E. coli of various proteins formed by fusion of certain foreign DNA sequences with the neo gene.

Kolowsky 17 discloses chimeric plasmids designed for transformation of the cyanobacterium Synechococcus R2, comprising an antibiotic-resistant gene linked to chromosomal DNA from the Synechococcus cyanobacterium.

Barnes, United States Patent No. 4,695,455, is directed to the treatment with stabilizing chemical reagents of pesticides produced by expression of heterologous genes (such as those encoding Bacillus proteins) in host microbial cells such as Pseudomonas bacteria. The host cells are killed by this treatment, but the resulting pesticidal compositions exhibit prolonged toxic activity when exposed to the environment of target pests.

D. The Grounds of Rejection
1. The § 103 Rejections

Claims 1-6, 16-21, 33-38, 47-48 and 52 (which include all independent claims in the application) were rejected as unpatentable under 35 U.S.C. § 103 based upon Dzelzkalns in view of Sekar I or Sekar II and Ganesan. The examiner stated that Dzelzkalns discloses a chimeric gene capable of being highly expressed in a cyanobacterium, said gene comprising a promoter region effective for expression in a cyanobacterium operably linked to a structural gene encoding CAT. The examiner acknowledged that the chimeric gene and transformed host of Dzelzkalns differ from the claimed invention in that the former's structural gene encodes CAT rather than insecticidally active protein. However, the examiner pointed out, Sekar I, Sekar II, and Ganesan teach genes encoding insecticidally active proteins produced by Bacillus, and the advantages of expressing such genes in heterologous 18 hosts to obtain larger quantities of the protein. The examiner contended that it would have been obvious to one of ordinary skill in the art to substitute the Bacillus genes taught by Sekar I, Sekar II, and Ganesan for the CAT gene in the vectors of Dzelzkalns in order to obtain high...

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