CAFC relies on extrinsic evidence to define a claim term and to demonstrate inherency

| February 23, 2018

Monsanto Technology LLC v. E.I. Dupont de Nemours & Co.

January 5, 2018

Before Dyke, Reyna and Wallach.  Opinion by Wallach.

Summary

 In this case, the CAFC affirmed a PTAB decision which relied on two pieces of extrinsic evidence.  First, a journal article referred to by the specification was used to define the bounds of “about 3% or less.”  Second, a Declaration submitted in the course of inter partes reexamination was used to demonstrate that claimed features are inherent in an anticipating reference.  The CAFC explained that both were appropriate, and the claims are invalid as being anticipated by the cited art.

Details

Monsanto appeals a PTAB decision invalidating the claims of U.S. Patent No. 7,790,953 in an inter partes reexamination.  Claim 1 of the ‘953 is representative and claims as follows:

A method of obtaining a soybean plant with an altered seed oil fatty acid composition comprising the steps of:

(a) crossing a first soybean parent line having a seed oil fatty acid composition comprising a linolenic acid content of about 3% or less of total seed fatty acids by weight with a second soybean parent line having a seed oil fatty acid composition wherein the i) level of oleic acid is greater than about 55% of total seed fatty acids by weight, or ii) wherein both the level of saturated fatty acid is about 8% or less of total seed fatty acids by weight and the level of oleic acid is greater than about 55% of total seed fatty acids by weight, said second soybean parent line comprising either a transgene that decreases the expression of an endogenous soybean FAD2-1 gene to provide the level of oleic acid greater than about 55% of total seed fatty acids by weight of said second parent soybean line of (i); or both a transgene that decreases the expression of an endogenous soybean FATB gene and a trans gene that decreases the expression of an endogenous soybean FAD2-1 gene to provide the level of saturated fatty acid of about 8% or less by weight and the level of oleic acid greater than about 55% of total seed fatty acids by weight of said second parent soybean line of (ii); and

(b) obtaining a progeny plant exhibiting a seed oil fatty acid composition comprising a linolenic acid content of about 3% or less of total fatty acids by weight and also comprising either i) an oleic acid level in the range of about 55% to about 80% of total seed fatty acids by weight, or ii) both a saturated fatty acid level of about 8% or less of total seed fatty acids by weight and an oleic acid level of about 55% to about 80% of total seed fatty acids by weight, thereby obtaining a soybean plant with an altered seed oil fatty acid composition.

The ‘953 patent discloses a process including crossing two parent soybean lines to produce soybean seeds with a modified fatty acid profile.  The result is a combination of transgenes which provides both moderate oleic acid levels and low saturated fat levels with soybean cells that contain mutations in genes that confer low linolenic acid levels (about 3% or less).  The claimed “progeny plant” is not specified to be a first generation (F1), second generation (F2) or later generation plant.

The PTAB indicated that the claims are anticipated by Booth (U.S. Patent No. 6,426,448), which discloses crossing of two soybean plant lines: a first line having a “fan allele” or a D3A gene for low linolenic acid content, and a second line having a D2T gene for high oleic acid content.  In the reexamination, Dupont filed two Declarations which provided further experimental results based on an example of Booth.  The Declaration included data from additional progeny produced by Booth’s method but “not selected for inclusion” in the data of Booth.  The PTAB relied on this to show that the F2 generation has the properties described in part (b) of claim 1.

Monsanto first argued that Booth cannot anticipate claim 1 because its first parent line contains 4% linolenic acid content and thus is outside the scope of “about 3% or less.”   However, the examples of the ‘953 patent make reference to a C1640 line as having a linolenic acid content of “about 3%.”  The specification also referred to a journal article to describe the origin of the C1640 line.  This journal article describes the linolenic acid content of C1640 to be 2.3% to 4.1%.  Thus, the CAFC concluded that “about 3% or less” may be reasonably interpreted as including 4% linolenic acid content, as in Booth.  Although Monsanto complained that the high end of the 2.3% to 4.1% range is an “outlier,” they provided no evidence of this point.

The CAFC went on to explain that the PTAB’s conclusion regarding anticipation was correct.  Booth described the fan allele line as having 4% linolenic acid content, and described the D2T line has having fatty acid content of 85% and the other requirements of claim 1.  Since “about 3%” was considered to include 4% based on the reasoning above, the CAFC concluded that Booth anticipates the subject matter of part (a) of the claim.  In other words, the fan allele line of Booth corresponds to the first parent line of claim 1, and the D2T line corresponds to the second parent line of claim 1.

However, Booth did not explicitly disclose the subject matter of part (b) of the claim.  Although Booth disclosed crossing the fan allele line with the D2T line, it did not include the results of this cross in its data.  Thus, Booth did not explicitly disclose the properties required in part (b).  Rather, Booth only reported a “select” subset of results.  But the CAFC indicated that this “does not foreclose” inherent anticipation.  For this point, the CAFC looked to the aforementioned Declarations, which demonstrated that the fan/D2T cross necessarily must have the properties recited in step (b) in its F2 generation.  In other words, the Declarations confirm that the cross of step (a) inherently gives rise to progeny having the properties described in step (b).

Monsanto also complained that this reasoning is improper because the Declarations are not prior art.  However, the CAFC replied that the Declarations do not expand the disclosures of Booth and are not prior art themselves.  Rather, the Declarations demonstrate what is inherent in the subject matter of Booth.  Extrinsic evidence is permitted to show what is inherently present in a prior art reference.  Furthermore, although Monsanto complained that this was “secret data” due to it not being published, Monsanto knew the origins of this data and had ample opportunity to rebut the conclusions in the Declaration.

Take-Away

This case serves as a helpful reminder of the power of extrinsic evidence.  In particular, extrinsic evidence can be used to define claim scope when explicitly cited in a specification.  Additionally, extrinsic evidence can be used to demonstrate inherent properties of prior art, even if the extrinsic evidence is not public, and even if it is created after the filing date of the patent.

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