Re. Patent Application 2,223,198 CD 1344
Patent application 2,223,198 is for a nutritional composition that has successfully caused Chrohn’s disease to go into remission in children. The application was rejected on the basis that the claimed composition and use was obvious in light of prior disclosures of the applicants work.
Two patents, one US the other EU claimed a nutritional supplement relying on a milk protein, casein, that was suitable for suppressing the inflammatory response in cells of the GI tract commonly associated with Chrohn’s disease. These papers disclose TGF-2 rich casein protein. Claim 1 of the patent application reads:
An enteral, nutritional composition for the treatment or prophylaxis of inflammatory
conditions of the gastro-intestinal tract, the composition comprising:
casein rich in TGF- 2;
a lipid source providing about 35% to about 50% of energy and containing a mixture
of medium and long chain triglycerides, wherein the medium chain triglycerides
provide at least 20% by weight of the lipid source, and the lipid source comprises less
than 10% of lipid energy from polyunsaturated essential fatty acids; and
a carbohydrate source;
the composition having an energy content of at least 800 Kcal/[L]; and wherein the
casein provides about 10% to about 14.5% of the energy of the composition and the
casein contains about 1.2 æg to about 2.0 æg of TGF- 2 per g of casein.
The claimed compositions in the patent are new relative to the US and EU patents as well as a scientific paper (the Beattie paper). The composition in Beattie was different than the composition in the present application.
The Board then turned its attention to whether there is an advantage over the US/EU/Beattie disclosures. If there was an advantage the board concludes that this may point to an inventive step. The Applicant indicated that full remission was achieved in 8 of 9 patients as opposed to 2 of 7 patients disclosed in the Beattie study. These results are less clear when examined in detail. The Applicant has applied a different standard when examining remission rates than was applied in Beattie. When similar standards are used the Beattie studied achieved as promising if not better results than the present application.
The Applicant focused on holistic remission. Performance across the spectrum of tests shows that Beattie is at least as effective as the present application. The Board was unwilling to accept that the Applicant’s present composition is inventive based upon their allegation of higher rates of remission.
The Applicant alleged that their use of lower levels of TGF-2 than that disclosed in Beattie was inventive. Their argument is based upon TGF-2 being historically identified as the active ingredient in Chrohn’s disease treatment. From the Board’s perspective the purpose of the Beattie study was not to explore ranges of TGF-2 that may be effective but rather to explore it as a solution. Reading Beattie in conjunction with the EU and US Patents supports this. The person of ordinary skill would read Beattie in conjunction with the US and EU patent and conclude that ranges of TGF-2 were acceptable.[56-58]
The Board found that all of the claims would have been obvious to a person of ordinary skill.