1. Pre-Grant Opposition under Section 25.(1) of Indian Patent Act 1970

TKDL Pre-Grant Opposition under Section 25.(1) brought to the notice of examination division the prior art references on the use of Withania somnifera (Ashwagandha), Acorus calamus, Bacopa monnieri(Brahmi), Glycirrhiza glabra(licorice), Phyllanthus niruri, Tephrosia pupurea, Ocimum sanctum(Tulasi), Embelia ribes, Piper longum(long pepper), Terminalia bellirica, Terminalia chebula (haritaki), Phyllanthus emblica (aamla) and Zingiber officinale(ginger) as General tonic, Memory Enhancer, Immuno potentiators/Anti ageing/Anti oxidant, Brain tonic, Intellect promoting and also used for the treatment of Immuno suppressive / Emaciating disease from the books – Ayurveda Sarasamgrahah (Ayurveda, Exhibit 1), Khazaain-al-Advia, Vol. I by Mohammad Najmul Ghani Khan (Unani, Exhibit 2, 4 & 8), Caraka Samhita by Agnivesa (Ayurveda, Exhibit 3), Brhat Nighantu Ratnakara (Saligramanighantubhusanam) - Compiled by Gangavisnu Srikrsna Dasa (Ayurveda, Exhibit 5), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani, Exhibit 6), Rasaratnasamuccayah by Vagbhattah (Ayurveda, Exhibit 7), Siddhayogasamgrahah - Compiled by Yadavji Trikamji Acharya (Ayurveda, Exhibit 9), Anandakandah by Manthana Bhairava (Ayurveda, Exhibit 10), Khazaain-al-Advia Vol II by Mohammad Najmul Ghani Khan (Unani, Exhibit 11), Rasatantrasarah Evam Siddhaprayogasamgrahah- part II(Ayurveda, Exhibit 12),Bharata Bhaisajya Ratnakara -Compiled by Naginadasa Chaganalala Saha (Ayurveda, Exhibit 13) and Gadanigrahah by Sodhala (Ayurveda, Exhibit 14).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 2, 3 & 4 are reproduced below.

“Objections :

Claim 1 is not patentable u/S 3(p)of the Act as it relates to Traditional knowledge.Refer the list of documents with date of publication (PRIOR ART) in enclosed TKDL documents D1:AK/4074, D2:NA2/339Z39, D3:BP/1840, D4:NA2/503G, D4:RS/4749, D5:NA4/4347, D6:RS1/1204, D7:NA2/464B, D8:RG10/121, D9: RS13/894, D10:AN2/172, D11:RS21/176, D12:AB/123,D13: RG2/1491,

Not withstanding above mentioned objection, Claim lacks inventive step u/S 2(1)( ja)of the Patents Act, 1970 in view of cited prior art documents D1-D13.

D1:(pg. no. 06-10) refers to a formulation containing Winter Cherry (Withania somnifera(Linn.) Dun.), coastal waterhyssop (Bacopa monnieri (Linn.) Penn.), Terminalia bellirica, Terminalia chebula, Acorus calamus, Zingiber officinale Roscoe, Piper longum, Embelia ribes along with few other ingredients used as an Intellect promoting, Memory enhancer and an Immunopotentiators/Anti ageing/Anti oxidant through oral administration.

D 2:(pg. no. 11-12) refers to a formulation containing-calamus (Acores calamus Linn.) as a single ingredient used as Brain tonic and Memory enhancer through oral administration.

D 3:(pg. no. 13-15) refers to a formulation containing calamus (Acorus calamus Linn.),Terminalia bellirica, Terminalia chebula, Phyllanthus emblica, Embelia ribes along with few other ingredients used as Memory enhancer and an Immune potentiators/Anti ageing/Anti oxidant through oral administration.

D 4:(pg. no. 16-18) refers to a formulation containing coastal waterhyssop (Bacopa monnieri (Linn.) Penn.) as a single ingredient used as Memory enhancer and General tonic through oral administration.

D 5:(pg. no. 19-21) refers to a formulation containing coastal waterhyssop (Bacopa monnieri(Linn.) Penn.) as a single ingredient used as Memory enhancer and an Immuno potentiators/Anti ageing/Anti oxidant. Mode of administration is as directed by physician.

D 6:(pg. no. 22-24) refers to a formulation containing cultivated licorice (Glycyrrhiza glabra Linn.) along with few other ingredients used for the treatment of general tonic for children through oral administration.

D 7:(pg. no. 25-27) refers to a formulation containing cultivated licorice (Glycyrrhiza glabra Linn.), Terminalia bellirica, Terminalia chebula, Phyllanthus emblica, Embelia ribes, Piper longum along with few other ingredients used as Memory enhancer, Intellect promoting and an Immuno potentiators/Anti ageing/Anti oxidant through oral administration.

D 8:(pg. no. 28-30) refers to a formulation containing gulf leaf-flower (Phyllanthus fraternus Webster Syn.: P. niruri auct. pl., non Linn.) along with one other ingredient used as General tonic through oral administration.

D 9:(pg. no. 31-36) refers to a formulation containing gulf leaf-flower (Phyllanthus fraternus Webster Syn.: P. niruri auct. pl., non Linn.), Terminalia chebula, Phyllanthus emblica, Piper longum along with few other ingredients used as an Intellect promoting, Memory enhancer and an Immuno potentiators/Anti ageing/Anti oxidant through oral administration.

D 10:(pg. no. 37-39) refers to a formulation containing Purple Tephrosia (Tephrosia purpurea (Linn.) Pers.) as a single ingredient used as an Immuno potentiators/Anti ageing/Anti oxidant. Mode of administration is as directed by physician.

D 11:(pg. no. 40-42) refers to a formulation containing Sacred basil, Holy basil (Ocimum sanctum Linn.) as a single ingredient used as General tonic. Mode of administration is as directed by physician.

D 12:(pg. no. 43-45) refers to a formulation containing Sacred basil, Holy basil (Ocimum sanctum Linn.) along with few other ingredients used for the treatment of Immuno suppressive / Emaciating disease through oral administration.

D 13:(pg. no. 46-49) refers to a formulation containing (Embelia vibes Burm. f. / Embelia tsjeriam-cottam A Dc Syn. E. robusta C.B Clarke), Long Pepper (Piper longum Linn.), Terminalia bellirica, Terminalia chebula, Phyllanthus emblica Linn. Syn.: Emblica officinalis, Acorus calamus, Zingiber officinale Roscoe along with few other ingredients used as Memory enhancer and an Immuno potentiators/Anti ageing/Anti oxidant through oral administration.

It would have been obvious to a person skilled in the art to have combined the teachings of the cited documents and have arrived at the instantly claimed composition.”

Full examination report can be referred at 1111-che-2010.pdf

3. Outcomes of TKDL References in Examination Report

As the outcome of TKDL Pre-Grant Opposition and other documents cited in examination report, Application is Abandoned U/S 21(1).