Ex Parte Edens et al

Patent Trial and Appeal BoardNov 28, 2012

10572811 (P.T.A.B. Nov. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte LUPPO EDENS, MELISSA HARVEY, and ROBERTUS ANTONIUS HOEVEN __________ Appeal 2011-013451 Application 10/572,811 Technology Center 1600 __________ Before DONALD E. ADAMS, STEPHEN WALSH, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to methods of administering a dietary supplement comprised of a proline specific endoprotease for ingestion to a patient, whereby the proline specific endoprotease is active in the stomach and is pepsin resistant. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-013451 Application 10/572,811 2 STATEMENT OF THE CASE The invention concerns the use of a proline specific endoprotease to hydrolyse proline rich peptides in a patient‟s stomach. Claims 9-12 and 23-31 are on appeal. Independent claims 9 and 11 are representative and read as follows: 9. A method of using a proline specific endoprotease to hydrolyse at a pH of below 5.5, proline rich peptides which are brought with celiac disease, a disease associated with the occurrence of celiac disease, or a disease caused by a decreased level in a patient's body of proline specific proteases required for breakdown of these peptides, the method comprising administering a dietary supplement or a medicament comprised of said proline specific endoprotease for ingestion by a patient in need thereof, whereby the proline specific endoprotease is active in the stomach and is pepsin resistant. 11. A method of using a proline specific endoprotease having a pH optimum below 6.5, the method comprising administering said proline specific endoprotease for ingestion by a patient in need thereof, whereby the patient suffers from celiac disease, a disease associated with the occurrence of celiac disease, or a disease caused by a decreased level in the patient's body of proline specific proteases, and whereby the proline specific endoprotease is active in the stomach and is pepsin resistant. The Examiner rejected the claims 9-12 and 23-31under 35 U.S.C. § 103(a) as unpatentable over Messer, 1 Hausch, 2 and Dekker. 3 1 M. Messer et al., Oral Papain in Gluten Intolerance, THE LANCET 1022 (1976). 2 Felix Hausch et al., Intestinal digestive resistance of immunodominant gliadin peptides, 283 AM. J. PHYSIOL. GASTROINTEST. LIVER PHYSIOL. G996- G1003 (2002). 3 Patent Application Publication No. WO 02/45524 A2 by Petrus Dekker et al., published Jun. 13, 2002. Appeal 2011-013451 Application 10/572,811 3 OBVIOUSNESS The Examiner‟s position is that Messer disclosed a method of treating patients by orally administering a dietary formulation or supplement comprising a digestive enzyme such as papain to help destroy gluten. (Ans. 5.) The Examiner found that Messer formulated its supplement as enteric- coated tablets to prevent inactivation of the papain in the acidic pH of the patient‟s stomach. (Id.) The Examiner also found that Messer did not explicitly disclose a method of using a proline specific endoprotease that is pepsin resistant and exhibits hydrolytic activity at pH below 5.5 or has a pH optimum below 6.5. (Id.) The Examiner found that Hausch disclosed that in vitro or ex vivo use of trace amounts of prolyl endopeptidase efficiently destroyed or digested immunodominant gliadin peptides that are typically resistant to enzymatic digestion in patients with such disorders as celiac disease. (Id. at 6.) The Examiner found that Hausch taught that its results suggested supplementing the celiac diet with bioavailable prolyl endopeptidase and that such treatment would be analogous to the enzyme therapy treatment in the case of lactose intolerance wherein orally administered lactase effectively cleaves lactose in milk products. (Id.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have modified Messer‟s method so that it used a dietary supplement comprising prolyl endopeptidase, as suggested by Hausch. (Id.) However, the Examiner found that Messer and Hausch did not disclose using proline specific endoprotease that is pepsin resistant, i.e., active in the stomach of a patient, has hydrolytic Appeal 2011-013451 Application 10/572,811 4 activity at the pH recited for the claimed invention, or is an Aspergillus niger enzyme. (Id. at 7.) The Examiner found that Dekker disclosed a proline-specific endoprotease derived from Aspergillus niger that is active in acidic environments having a pH optimum below 6.5 (preferably pH 3.5 to 6.5) and effectively degrades proline-rich peptides that are allergenic. (Id. at 7-8.) According to the Examiner, a skilled artisan would have been motivated to substitute a better proline-specific endoprotease, such as the enzyme disclosed by Dekker, to achieve a superior method of treating patients with celiac disease. (Id. at 8.) Appellants contend that Messer and Hausch lead away from the claimed invention which requires the proline specific endoprotease to be active in the stomach. Specifically, Appellants assert that Messer taught a method of using its enzymes to act “„within the small intestine,‟” rather than in the stomach, which is why Messer formulated the tablet with an enteric- coating. (App. Br. 9.) Appellants assert that Hausch discusses a method of using endopeptidase to break down gliadin peptides in the brush-border membrane (BBM) located in the intestinal wall. (Id. at 10.) Appellants assert that Dekker also does not provide a teaching or suggestion of a method comprising administering proline specific endoprotease for ingestion by a patient whereby the proline specific endoprotease is active in the stomach, as this reference is directed to in vitro treatment of food products rather than to its use in vivo. (Id. at 11.) Therefore, Appellants assert that a skilled artisan would not have been motivated by Messer and/or Hausch to provide a method of using a proline specific endoprotease to hydrolyse Appeal 2011-013451 Application 10/572,811 5 proline rich peptides in the stomach, as required by the claimed invention. (Id.) After considering the evidence and the arguments, we agree with Appellants that the Examiner has not established that the claimed invention is prima facie obvious. For the reasons discussed by Appellants, we conclude that the prior art, either alone or in combination, did not teach or suggest a method of administering a dietary supplement or a medicament comprised of proline specific endoprotease for ingestion by a patient, whereby the proline specific endoprotease is active in the stomach. Accordingly, we reverse the obviousness rejection. REVERSED cdc