Ref: Examiner(s) Comments in the Examination Report Dated: 20.02.2012 on TKDL Submission Dated: 07.10.2009 in the context of Patent Application No. 05711431.6 (EP1722805) 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 Camellia sinensis (Green Tea) for the treatment of cancer of inflammation from the book – Khazaain-al-Advia by Mohd Najmul Ghani Khan (Unani, Exhibit 1 & 2).

2. Relevant Extract of EPO Examination report

EPO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report reproduced below:

Inventive step (Article 56 EPC)

The therapeutically benefit of tea is known in the prior art. The preparation of tea for medical treatment generally comprises brewing of fresh or dried tea leaves. The problem to be solved is the provision of an alternative method to obtain bioactive composition of Camellia. The solution provide by the applicant is the fractionation of fresh tea leave prior to heating or drying. The advantage associated with this method is the prevention of degradation of bioactive substances.

The Examining Division agrees with the applicant in that intentive merit can be acknowledged to an alternative method, however, this holds only true if said method was not obvious.

In light of the prior art the method claimed in claim 1 is considered one of several straightforward possibilities which the skilled person would select, depending on the circumstances. Without exercising inventive skill, in order to solve the problem posed. The person skilled in the art interested in the isolation of a bioactive compounds known to be present in a plant would use a method that is most gentile to said bioactive compounds. Since the anti inflammatory substances do survive conventional tea procession like being boiled before being formulated into a thick paste (see document E 1 submitted by the Third Party), a method that lacks the step of boiling the tea leaves will most likely lead to a product which is at least equally potent in inhibiting inflammation.  Due to the fractionation the person skilled in the art would expect an increased concentration of such bioactive compound in one of the fractions associated with an increased bioactivity.

Besides the omission of any heating or dying, is the claimed method based on steps which are generally used for the fractionation of plant tissue e.g. centrifugation, filtering, coagulating and precipitation.

The claimed method in claims 1-16 and 29-32 (1-16 and 27-30 in AR 1) is therefore considered to lack inventive step according to Article 56 EPC.”

Full examination report can be referred at EP1722805.pdf

3. Outcomes of Third Party Observations & Examination Report.

As the outcome of TKDL third party and other documents cited in examination report the examination of the application is still under process and reply is awaited from the Applicant INTEGRATED BOTAN, United States.