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 Rheum palmatum, Zingiber officinale (ginger), Saussurea lappa (saw-wort), Gypsum (godanti) and Talc for the treatment of Influenza, Cough / Bronchitis, Headache, Vomiting / Emesis, Nausea, Pneumonia and Pyrexia from the books – Brhat Nighantu Ratnakara (Saligramanighantubhusanam)Vol.-4 (Part VII) ( Ayurveda, Exhibit 1 & 3), Priyanighantu by Priyavrata Sharma (Ayurveda Exhibit 2), Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 4), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan ( Unani, Exhibit 5), Ayurveda Sarasamgrahah (Ayurveda, Exhibit 6 & 8), Bharata Bhaisajya Ratnakara Vol.-V (Ayurveda, Exhibit 7) and Brhadrasarajasundarah (Ayurveda, Exhibit 9).

2. Relevant Extract of EPO Examination report

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

"Moreover, the following documents cited in the ‘Third Party Observation’ under Article 115 EPC, are considered as being relevant, since they relate to the same medical/therapeutic indication of “influenza”, namely Exhibits 4, 6, 7, 9 for the reasoning as follows.

Exhibit 4 refers to a formulation containing ginger (Zingiber officinale Roscoe), along with one other ingredient used for the treatment of influenza through oral administration.
Exhibit 6 refers to a formulation containing Calcium sulphate or Gypsum along with one other ingredient used for the treatment of Pneumonia and Influenza through oral administration.
Exhibit 7 refers to a formulation containing ginger (Zingiber officinale Roscoe) and Saussurea lappa Clarke along with few other ingredients used for the treatment of Pyrexia and Influenza through oral administration.
Exhibit 9 refers to a formulation containing saw-wort (Saussurea lappa Clarke) and Zingiber officinale Roscoe along with few other ingredients used for the treatment of influenza and Chronic pyrexia through oral administration.

However, each of these (22) ingredients was already known (alone or in combination with some other herbs from the listed plants) in the prior art as being effective in the treatment or prevention of influenza, see D1– D16 and Exhibits 4, 6, 7, 9 as referred to above.

Therefore, the fact that a mixture of many anti-influenza drugs is useful again in the treatment/prevention of influenza virus-induced disease, is not considered as being unexpected / surprising, as long as no more than an additive effect (such as a synergistic effect) has been shown, Hence, a lack of inventive merits in the sense of Article 56 EPC is objected.”

Full examination report can be referred at EP2497482.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 is under process and reply is still awaited from the Applicant Korea Institute of Oriental Medicine / SOUTH KOREA.