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 Withania somnifera (Ashwagandha) for the treatment of hyperacidity, gastric ulcer, anaemia, insomnia, convulsion, diabetes mellitus, excessive perspiration, restlessness and depression from the books – Ayurveda Sarasamgrahah (Ayurveda, Exhibit 1), Vangasena by Vangasena (Ayurveda, Exhibit 2), Khazhaain- al-Advia by Mohd. Najmul Ghani Khan (Unani, Exhibit 3), Ayurveda Sarasamgrahah (Ayurveda, Exhibit 4), Muheet Azam by Mohd. Azam (Unani, Exhibit 5) Athmarakshaamirtham by Kandasamy Mudaliar (Siddha, Exhibit 6), Therayar Karisal by Therayar (Siddha, Exhibit 7) Athmarakshaamirtham by Kandasamy Mudaliar (Siddha, Exhibit 8), Khazaain-al-Advia by Mohd. Najmul Ghani Khan (Unani, Exhibit 9), Agathiar Vaithiam 600 by Agasthiyar (Siddha, Exhibit 10), Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda Exhibit11), Bayaaz-e-Kabir by Kabiruddin (Unani, Exhibit 12), Chikithsa Rathna Deepam by Kannusamy Pillai (Siddha, Exhibit 13), Athmarakshaamirtham by Kandasamy Mudaliar (Siddha, Exhibit 14) and Vaithya Chinthamani by Yugi (Siddha, Exhibit 15).

2. Relevant extract of EPO Examination Report

EPO Patent Examiner(s)  took cognizance of TKDL references. Extract of examination report at Para 2 & Para 3 are reproduced below:

“Documents considered to be relevant:

D10:     DATABASE TKDL “Asvagandhadi Yoga” retrieved from TKDL
            Database accession no. AK11/4074

D11:     DATABASE TKDL “Asvagandhadi Curna” retrieved from TKDL
            Database accession no. RG12/1062

D12:     DATABASE TKDL “Parangi Chooranam -7” retrieved from TKDL
            Database accession no. AM05/1804

D13:     DATABASE TKDL “Aswaganthathy Chooranum” retrieved from TKDL
           Database accession no. SP01/75

D14:     DATABASE TKDL “Vaayu Thiratchiku Mezhugu” retrieved from TKDL
            Database accession no. AM05/1838

D15:     DATABASE TKDL “Safoof – e- Asgandh 1” retrieved from TKDL
            Database accession no. NA2/108V

D16:     DATABASE TKDL “Amukkara Karpam” retrieved from TKDL
           Database accession no. PD04/54

D17:     DATABASE TKDL “Phalasava” retrieved from TKDL
           Database accession no. RS21/797

           The document D10 is an entry of the Traditional Knowledge Digital Library which refers to a composition comprising Withania somnifera root powder, a product of sugarcane and clarified butter. This composition is useful for the treatment of insomnia.

            The Search Authority considers that the Withania somnifera extract used in this composition will comprise Withanolide glycosides, oligosaccharides and Withanolide aglycones since this compounds are naturally present in Withania somnifera roots.

Insomnia is considered to be chronic stress disorder.
Clarified butter is considered to comprise fatty acids and vitamins.
In the light of this document, the subject-matter of claims 1-4, 6-7, 10-11, 13-17, 20-26, 28 and 29 cannot be considered as novel (Article 54 EPC).

           The document D11 is an entry of the Traditional Knowledge Digital Library which discloses a therapeutic composition for the treatment of insomnia which comprises a root extract form Withania somnifera and a  root extract from Argyeria nervosa (a plant extract). Said composition can be administered together with milk or water and is thus considered to fulfill the definition of a beverage.

           The Search Authority considers that the Withania somnifera extract used in this composition will comprise withanolide glycosides, oligosaccharides and withanolide aglycones since this compounds are naturally present in Withania somnifera roots.

Insomnia is considered to be a chronic stress disorder.
In the light of D11, the subject –matter of claims 1-4, 6-11, 13-17, 20-26, 28 and 29 cannot be considered as novel in the sense of Article 54 EPC.

 Document D12, D13 and D16 are entries of the Traditional Knowledge Digital Library   which disclose therapeutic compositions comprising a Withania somnifera root extract together  with other plant extracts for the treatment of gastric ulcers or acute gastritis. The composition is   in    the form of powder.

The search Authority considers that the Withania somnifera extract used in these compositions will comprise withanolide glycosides, oligosaccharides and withanolide aglycones since this compounds are naturally present in Withania somnifera roots.

Gastric ulcers are considered to be chronic stress disorders.
Therefore, the subject-matter of claims 1-4, 6-7, 11-17, 20-26, 28 and 29 cannot be considered as novel (Article 57 EPC).

           The document D14 is an entry of the Traditional Knowledge Digital Library which discloses a therapeutic composition for the treatment of gastric ulcers and acute gastritis comprising numerous plant extracts. One of these Extracts is a Withania somnifera root extract.  The composition further comprises garlic extracts.  The composition is waxy.

The search Authority considers that the Withania somnifera extract used in this composition will comprise withanolide glycosides, oligosaccharides and withanolide aglycones since this compounds are naturally present in Withania somnifera roots.

Gastric ulcers are considered to be chronic stress disorders.
Therefore, the subject-matter of claims 1-4, 6-7, 11-17 and 20-30 cannot b e considered as   novel (Article 54 EPC).
The document D 15 is an entry of the Traditional Knowledge Digital Library which disclose a therapeutic composition for the treatment of restlessness and depression comprising Witnania somnifera bark, leaf, flower, fruit and root extracts, Terminalia bellirica root extract and a sugar cane product.  The composition is formulated as a powder.

The Search Authority considers that the Withania somnifera extract used in this composition will comprise withanolide glycosides, oligosaccharides and withanolide aglycones since this compounds are naturally present in Withania somnifera roots.

Restlessness and depression are considered to be chronic stress disorders.
Therefore, the subject-matter of claims 1-4, 6-7, 10-11, 13-17, 20-26, 28 and 29 cannot be considered as novel over the teaching of D 15 (Article 54 EPC).

The document D17 is an entry of the Traditional Knowledge Digital Library which discloses a therapeutic composition for the treatment of hyperacidity and insomnia comprising numerous plants extracts including a Withania somnifera root extract.  The composition is in the form of a fermented alcoholic product and fulfills the definition of a beverage or elixir. The Search Authority considers that the Withania somnifera extract used in this composition will comprise withanolide glycosides, oligosaccharides and withanolide aglycones since this compounds are naturally present in Withania somnifera roots.

Hyperacidity and insomnia are considered to be chronic stress disorders.
Therefore, the subject-matter of claims 1-11, 13-17, 20-26, 28 and 29 cannot be considered as novel over the teaching of D17 (Article 54 EPC).”

Full examination report can be referred at EP1906980.pdf

3. Outcome of  Third Party Observation and Examination Report

As the outcome of TKDL third party and other documents cited in examination report Applicant M/s Natreon Inc, United States, did not reply to communication from the Examining Division as a result of which the Application was deemed to be withdrawn on 25.03.2010.