No Motivation To Modify Product-Specific Method With Method Features For Different Products

• Published date: 17 July 2023
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Author: Derek Lightner

On July 10, 2023, the Patent Trial and Appeal Board (PTAB) reversed an examiner's finding of obvious on the basis of a failure to show a motivation to modify the prior art and a lack of a reasonable expectation of success. The appeal (No. 2023-002080, USSN 15/558,153, Technology Center 1700) of Ex parte MARK HETHERINGTON began with the filing of a Notice of Appeal on May 13, 2022, after filing the national stage application on September 13, 2017. The main appealed claim recited:

[a] process for producing a meal fraction of Brassica carinataoilseed having reduced sinigrin content, the method comprising:

a. pressing seeds of Brassica carinataoilseed to produce oilseed flakes;

b. cooking the oilseed flakes at a temperature in the range of 105'C to 180'C;

c. pressing the cooked oilseed flakes to remove oil from the oilseed flakes, thereby producing an oil fraction and a meal fraction;

d. treating the meal fraction with hexane to extract residual oil;

e. desolventizing-toasting the hexane-extracted meal fraction to remove residual hexane for a period of greater than 1 hour but less than 5 hours; and

f. drying the meal fraction to a moisture content of 12% or less, and

g. recovering a meal fraction of Brassica carinatahaving a sinigrin content of less than 20 μmol per gram of meal.

The claims were rejected by Examiner Stefanie Cox, supervised for the first three years of prosecution by Primary Examiner Michele Jacobson, under Supervisory Patent Examiner Amber Orlando, all of whom were conferees in the ultimate decision to force an appeal upon the applicant. That is, the applicant received nine office actions from Examiner Cox, of which five were signed by Examiner Jacobson, and the Examiner's Answer (to send the appeal brief to the PTAB) was signed by Examiners Cox, Jacobson, and Orlando.

Given the breadth of the reversal of the examiner's position, the prosecution history of the Hetherington application warrants discussion. The original independent claims of the Hetherington application, i.e., claims 1, 25, and 29, are provided below.

Claim 1: A process for removing at least one glucosinolate from a meal fraction of oilseed comprising:

(a) treating the meal fraction of oilseed with exogenous myrosinase to convert the at least one glucosinolate to a volatile isothiocyanate; and

(b) removing the volatile isothiocyanate from the treated meal fraction of oilseed under conditions of mild heat and negative pressure.

Claim 25: A process for removing at least one glucosinolate from a meal fraction of a Brassica carinataoilseed comprising:

(a) heating and applying pressure to the oilseed before, during, or after the extraction of oil;

(b) treating the meal fraction of oilseed with exogenous myrosinase to convert the at least one glucosinolate to a volatile isothiocyanate; and

(c) removing the volatile isothiocyanate from the treated meal fraction of oilseed under conditions of mild heat and negative pressure.

Claim 29: A process for removing at least one glucosinolate from a meal fraction of a Brassica carinataoilseed comprising heating and applying pressure to the oilseed before, during, or after the extraction of oil.

As detailed in the background of the Hetherington application and in the PTAB decision, the pressed fibrous remainder from Brassica carinata oilseed crops (also known as "Ethiopian mustard" or "carinata") contains high levels of glucoinolates, i.e.,

which limit its utility as a livestock feed. Carinata varieties are useful in making "biofuels," and it would be useful to use the pressed fibrous remainder as feed, as is done for other oilseed plant materials. Glucosinolates and their metabolites can be harmful to livestock. Certain glucosinolates are known to be degraded by enzymes such as myrosinase, which is naturally present in mustard seeds, in a water hydrolysis breaking down, e.g., sinigrin (2-propenyl glucosinolate or allyl glucosinolate) into glucose, allyl isothiocyanate (responsible for the "bite" of horseradish and wasabi), and a sulfate anion, seen below.

Certain glucoinolates adversely affect animal health, and their hydrolysis can interfere with animal thyroid function.

The claims were initially rejected as lacking novelty over US 2005/0031768 A1 (Sakai), which describes obtaining or preparing a mustard seed stock, wherein

[t]he mustard seed stock is cracked, either by grinding or crushing or pressing or other activities. Alternatively, a mustard cake material produced by the prior crushing of mustard seed could also be used and that cake could be broken up or blended with any other raw mustard seed material to create the initial starting batch of mustard seed stock to be used in the process. Once the mustard seed stock has been cracked, the process can be continued.

[0027] Regardless of the starting material, the next stage in the process involves placing the cracked mustard seed stock along with water in a reaction chamber in which hydrolysis and distillation can occur under...