EP1795200

Ref: Examiner(s) Comments in the Examination Report Dated: 23.02.2011 on TKDL Submission Dated: 26.04.2010 in the context of Patent Application No. 05727328.6 (EP1795200) at EPO


1. Third Party Observations under article 115 of EPC

TKDL third party submission under Article 115 EPC brought to the notice of examination division the prior art references on the use of Aloe barbadensis Miller(Indian Aloe) used for the treatment of Diabetes mellitus (hyperglycemia) from the books namely Muheet-e-Azam by Mohammad Azam Khan, (Unani, Exhibit 1), Azam Muheet Azam by Mohd. Khan, (Unani, Exhibit 2), Khazaain-al-Advia by Mohammad Najmul Ghani Khan, (Unani, Exhibit 3), Anuboga Vaithiya Navaneetham by Abdulla Sahib, (Siddha, Exhibit 4), Therayar Yamagam by Therayar, (Siddha, Exhibit 5), Anuboga Vaithiya Navaneetham by Abdulla Sahib (Siddha, Exhibit 6), Anuboga Vaithiya Navaneetham by Abdulla Sahib, (Siddha, Exhibit 7), and Rasatantrasarah Evam Siddhaprayogasangrahah - part I,(Ayurveda, Exhibit 8)

2. Relevant Extract of EPO Examination report

EPO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report para 1 and 2are reproduced below:

“D6      “Appiraka Chendooram” KEY ATTRIBUTES OF THDL,, 1 January 1879 (1879-01-01), pages 1-3, XP007913282

D7       “Nuskha-e-zulla” KEY ATTRIBUTES OF TKDL,, 1 January 1899 (1899-01-01), pages 1-2, XP007913278

D6       discloses the subject matter of claims 1-16, i.e. a composition comprising the juice of Aloe barbadensis Miller is useful for treating diabetes mellitus.

D7 discloses the subject matter of claims 1-16, i.e. that Aloe barbadensis mill. Is useful for treating diabetes mellitus
Should the applicant overcome the above raised objections of lack of novelty an inventive step has to be demonstrated over D1-D4,D6-D9, as the present documents (Art. 56 EPC). The person skilled in the art when confronted with 24- methylene-9,19-cyclolanostan-3ol in isolated form or as a plant extract or food or beverage, without exercising inventive skills.

At least some of the objections raised above are such that there appears to be no possibility of overcoming them by amendment. Refusal of the application under Article 97 (2) EPC is therefore to be expected.”

Full examination report can be referred at EP1795200.pdf

3. Outcomes of Third Party Observations & Examination Report.

As the outcome of TKDL third party and other documents cited in examination report Applicant MORINAGA MILK INDUSTRY CO. LTD. Japan, decided to amend the claims on 29.07.11. The examination of the application is under progress.

Analysis of amendment of claims

The Applicant originally claimed the usefulness of a compound (9, 19-cyclolanostan-3-ol or 24-methylene-9, 19-cyclolanostan-3-ol) from Aloe vera (Aloe barbadensis) for improving hyperglycemia to be novel. TKDL submitted its prior art evidences stating the usefulness of   Aloe vera (Aloe barbadensis) for the treatment of Diabetes mellitus. Based on the TKDL evidences and Examiner’s report the Applicant amended the claims by specifying that the composition is an extract selected from an ethyl acetate/butanol mixture extract and a chloroform/methanol mixture extract of Aloe vera (Aloe barbadensis).