USPTO Seeks Comments on Harmonization

The United States Patent and Trademark Office (USPTO) is seeking comments to obtain the views of the public on international efforts to harmonize substantive requirements of
patent laws, and any potential subsequent changes to United States law and practice. Comments may be offered on any aspect of these efforts and will be accepted on a continuous basis until June 22, 2007.

The purpose of the notice is to identify and briefly outline issues that have arisen and are likely to arise during meetings of the ‘‘Group B+’’ and the Standing Committee on the Law of
Patents (SCP), meeting under the auspices of the World Intellectual Property Organization (WIPO).

According to the notice "consensus has not been reached on a particular work plan" in the WIPO body. Since early 2005, a group of countries, sometimes referred to as the ‘‘Alexandria Process’’ or the ‘‘Group B+,’’ began meeting informally to advance discussions on patent law harmonization in WIPO in the categories of: (1) Definition of prior art, (2) grace period, (3) novelty, and (4) inventive step or non-obviousness. Each of these items relates to applicability of ‘‘prior art.’’ These four categories are commonly referred to as the ‘‘limited package’’ and are the core elements in patent examination in countries around the world. The ‘‘B+’’ countries include the United States, Canada, Japan, Australia, New Zealand, Norway, the Members of the European Union and the Members of the European Patent Convention.

Issues specifically identified for consideration include

1. Priority of Invention.
2. Prior Art Effective Date of Published U.S. Patent Applications.
3. Scope of Prior Art Effect of Published Patent Applications.
4. Grace Period.
5. Geographical Limitations in the Definition of Prior Art.
6. ‘‘Loss of Right’’ Provisions.
7. ‘‘Experimental Use’’ Exception to Prior Art.
8. Prior User Rights.
9. Assignee Filing.
10. Eighteen-Month Publication of Patent Applications.

Suggestion that "Might Still Be Expected to Increase Efficiency" Sufficient to Suport Jury Finding on Obviousness

In Syngenta Seeds, Inc. v. Monsanto Co. (May 3, 2007; Bryson, J.), the Federal Circuit cited the Supreme Court decision in KSR v. Teleflex for the first time and affirmed an obviousness holding for several patents:

While "the ultimate judgment of obviousness is a legal determination," KSR Int'l
Co. v. Teleflex Inc., No. 04-1350, slip op. at 23 (U.S. Apr. 30, 2007), that determination is necessarily based on underlying factual inquiries, see Winner
Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed. Cir. 2000). When reviewing a jury verdict of obviousness, "[w]e first presume that the jury resolved the underlying factual disputes in favor of the verdict winner and leave those presumed findings undisturbed if they are supported by substantial evidence. Then we examine the legal conclusion de novo to see whether it is correct in light of the presumed jury fact findings." Jurgens v. McKasy, 927 F.2d 1552, 1557 (Fed. Cir. 1991) (citation omitted).

The pertinent claims of the '865 patent describe a transgenic corn plant that produces a certain protein "wherein the foreign DNA nucleic acid coding sequence has a G+C content of at least about 60%." Syngenta argued that while the general notion of substituting codons (sequences of three adjacent nucleotides that control protein synthesis) rich in G+C may have been obvious, the idea to modify the coding sequence of the Bacillus thuringiensis ("Bt") bacterium gene (that produces a protein toxic to certain insects) to increase the G+C content to more than 60 percent would not have been obvious. Although a portion of the prior art application suggested that positive results could be achieved without modifying the entire DNA sequence:

Since the [positive] results did not seem to vary greatly based on the length of
the substituted codons, it is possible that the increased expressional
efficiency is due principally to the substitutions at the amino-terminal, or 5',
end of the coding sequence, perhaps those in the first 25 codons. . . . If true,
this would suggest that entire coding regions need not be altered to gain a
relatively significant increase in efficiency of expression, merely the
amino-terminal end of the coding region, for perhaps about 25 codons. Performing
such a codon substitution for the remaining portion of the coding region might
still be expected to increase efficiency of expression, although perhaps less
dramatically.

according to the court,

. . . including the conclusion that a complete codon substitution "might still be
expected to increase efficiency of expression," plainly constitutes a suggestion
that some increased efficiency of expression could be achieved by producing a
synthetic Bt gene with a coding region consisting entirely of plant-preferred
codons.

Syngenta also argued that even if a gene modification resulting in a G+C content of more than 60 percent was obvious to try, there was no reasonable basis to expect that such a modification would lead to a significantly improved level of expression of the Bt protein, and thus no basis for the jury’s finding of obviousness. However, according to the Federal Circuit,

The jury was properly instructed, and it concluded, with ample basis in the
record, that the prior art gave rise to a reasonable expectation of success from
the formulation found in the asserted claims. . . . The jury was entitled to
rely on that portion of the Barton application in concluding that there was a
reasonable expectation of success from such an increase in the G+C content of the codons in the genetic sequence. . . . [O]ther prior art references that fail to suggest a G+C content of greater than 60 percent . . . do little to offset the clear suggestion in the Barton application that complete codon substitution would rease in the G+C content of the codons in the genetic sequence. . . . Although [one] reference cuts against a finding of obviousness, the jury was entitled to weigh Fischhoff against the other evidence and conclude, as a factual matter, that there was a reasonable expectation of success from substituting plant-preferred codons in place of the codons found in the native Bt gene.

The court also reiterated that the doctrine of waiver precludes a party from advocating a new theory of claim constriction on appeal:

Because Syngenta never raised its present proposed construction before the
district court, its proposed construction is waived. As Syngenta has not
challenged the construction of the '100 and '185 patent claims on any other
ground, we affirm the judgment of noninfringement.