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 Glycyrrhiza glabra (licorice) and Zizyphus jujube for the treatment of Melancholia, Insomnia, Idiopathic psychotic syndrome, Psychosis/Insanity/Mania, Depression, Psychoneurosis, Palpitation, Hallucinations and as Brain tonic and Sedative/ Anxiolytic from the books – Ikseer Azam, Vol. I by Mohammad Azam Khan (Unani, Exhibit 1), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani, Exhibit 2), Astanga Hrdaya by Vagabhata (Ayurveda, Exhibit 3), Astanga Hrdaya by Vagabhata (Ayurveda, Exhibit 4), Arkaprakasah by Lankapatiravana (Ayurveda, Exhibit 5), Brhat Nighantau Ratnakara (Saligramanighantubhusanam)(Ayurveda, Exhibit 6), Siddhabhesajamanimalah by Krsnarama Bhatta (Ayurveda, Exhibit 7), Bayaaz-e-Kabir, Vol. II by Mohammad Kabiruddin (Unani, Exhibit 8), Khazaain-al-Advia, Vol. I by Mohammad Najmul Ghani Khan (Unani, Exhibit 9), Yogaratnakarah (Ayurveda, Exhibit 10) and Ikseer Azam, Vol. IV by Mohammad Azam Khan (Unani, Exhibit 11).

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 & 5 are reproduced below.


“The application lacks novelty and inventive step in view of the citations below. Reference is made to the following documents: 1. Mohammad Azam Khan; Ikseer Azam, Vol. I (19th century AD), Munshi Nawal Kishore, Lucknow, Fourth Edition Pg 19 ormulation ID: NA5/2 506B . Formulation Name: Sharbat-e- Unnab Bara-e- Maali Kholia 2.Mohammad Akmal Khan; Qaraabaadeen Azam wa Akmal (20th century AD), Matba Siddiqi, Delhi I Matba Mu stafai, Delhi, 1909 AD P 6, Formulation ID: BA3/ 17, Formulation Name: Itreefal Muqawwi Dimagh 3 .Vagabhata; A tailga Hrdaya - (commentary by Arunadutta) edited by Bhisagacarya Harisastri Paradakara vaidya : Chaukhamba Orientalia aranasi, edn. 8th, 1998. [Time of origin 5th century] Pg 383, Formu lation ID: RS23/302, Formulation Name: BaJa Tail Nirupanam 4 .Vagabhata; A ta1iga Hrdaya - (commentary by Arunadutta) edited by Bhisagacarya Harisastri Paradakara vaidya : Chaukhamba Orientalia aranasi, edn . 8th, 1998. [Time of origin 5th cent4ry] Pg 795 formulation ID: RS23 / 1330, Formulation ID: RS23 / 1330 formulation Nam e: Mahabhutarava Ghrta 5. .Lankapatiraval)a; ArkaprakasaJ:i -Edited and translation by Indradeva Tripathi; Krishnadas Academy, Varanasi, Edn . 1st 1995 Pg 41 Formulation ID:? AK14/40A, , Formulation Name: Jalayasti Arka Gunah ID.-; 6. Brhat Nighaz:!tu Ratnakara (Saligramanighantubhusanam) - Compiled by Gangavi I)U Srikr z:!a Dasa , Translated by Sri Dattarama rikrsnalala Mathur a; Vol.-4 (Part VII), edn. 1997, Khemaraja Srikrsnadas Prakasana, Mumbai-4 [This book contains back references from 000 B.C.to 20th century] Pg 130 Formulation ID: RS/ 4246 Formulation Name: Jalaya tyarkagul)aaJ:i 7 .Kr I)arama Bhatta; Siddhabhe ajamal)imalaJ:i - Commentary by Kaladhara Bhatta, Chaukhambha J<;rishnadas Academy, Varanasi, Edn .3rd 2003 Pg 56 Formulation ID: RS4/167C Formulation Name: Badara Phala (pakva) 8.Mohammad Kabiruddin; Bayaaz-e-Kabir, Vol. II (Compiled), Daftar-al- Maseeh, Karol Bagh, New Delhi, 193 8 AD Pg 119 Formulation ID: MA3/ 442, Formulation Name: Arq-e- Unnab 9.Mohammad Najmul Ghani Khan; Khazaain-al-Advia, Vol. I (20th century AD), Nadeem Yunus Printer I Sheikh Mohd Basheer & Sons, Lahore, I 91 I AD Pg 8 I 7 Formulation ID: NA2/3 841Formulation Name: Dawa -e- Safoof Labni 10.-; YogaratnakaraJ:!- Commentary by Lak mipatisastri, Chaukhamba Sanskrit Sansthan, Varanasi Edn. 8th 2004 Pg 497 Formulation ID: RG8/ 1894, Formulation Name: Yasthyadi Yoga 11.Mohammad Azam Khan; Ikseer Azam, Vol. IV (19th century AD), Matba Nizami, Kanpur, 1872 AD Pg 364, Formulation ID: BA4/2158, Formulation Name: Matbookh-e- Musakkin.....

Exhibits 1-4 & 12 are relevant for the purpose of novelty & discussed here. Exhibit 1:{pg. no.5-8) refers to a formulation containing cultivated licorice(Giycyrrhiza glabra Linn.)"and Zizyphus jujuba Linn. along with few other ingredients used for the treatment of Melancholia and Insomnia through oral administration. Exhibit 2:(pg. no.9-12) refers to a formulation containing cultivated licorice(Giycyrrhiza glabra Linn.) and Zizyphus jujuba Linn. along with few other ingredients used as Brain tonic through oral administration. Exhibit 3:(pg. no.13-18) refers to a formulation containing Ziziphus jujuba Mill. and cultivated licorice (Giycyrrhiza glabra Linn.) along with few other ingredients used for the treatment of Idiopathic psychotic syndrome and Psychosis/Insanity/Mania. Mode of administration is as directed by physician. Exhibit 4:(pg. no.19-23) refers to a formulation containing cultivated licorice (Giycyrrhiza glabra Linn.) and Ziziphus jujuba Mill. along with few other ingredients used for the treatment of Idiopathic psychotic syndrome and Psychosis/Insanity/Mania through oral administration. The instant application claims the usefulness of a herbal composition comprising ginseng, liquorice and jujuba for treating an anxiety disorder. However prior art 1-4 disclose cultivated licorice (Giycyrrhiza glabra Linn.) and Zizyphus jujuba Linn. have been used for the treatment of Melancholia, Insomnia, Idiopathic psychotic syndrome, Psychosis/Insanity/Mania, Depression, Psychoneurosis, Palpitation, Hallucinations and as Brain tonic and Sedative/ Anxiolytic through oral administration or as directed by physician in the Indian systems of Medicine since long. Thereby claims 1-6 of instant application lacks novelty in view of the cited prior art 1-4. Exhibit 12 discloses (cf. claims) pharmaceutical compositions comprising (i) ginseng and (ii) liquorice with or without (iii) jujuba for use in the treatment of depression, and pharmaceutical compositions comprising (i) ginsenoside from ginseng and (ii) glycyrrhizic acid and/or glycyrrhetinic acid from liquorice with or without (iii) jujuba cAMP for use in the treatment of depression.

The subject-matter of claims 1-12 of the present application cannot be considered to involve an inventive step u/s 2(1)(ja) in view of the citation exhibits 1-12. In addition to exhibits 1-4 and 12 discussed for novelty & relevant here, the exhibits 5-11 are relevant here Exhibit 5:(pg. no.24-25) refers to a formulation containing cultivated licorice (Giycyrrhiza glabra Linn.) as a single ingredient used for the treatment of Depression through oral administration. Exhibit 6:(pg. no.26-27) refers to a formulation containing cultivated licorice(Giycyrrhiza glabra Linn.) as a single ingredient used for the treatment of Depression. Mode of administration is as directed by physician. Exhibit 7:(pg. no.28-29) refers to a formulation containing Ziziphus jujuba Mill. as a single ingredient used for the treatment of Psychoneurosis. Mode of administration is as directed by physician. Exhibit 8:(pg. no.30-31) refers to a formulation containing Zizyphus jujuba Linn. along with one other ingredient used as Brain tonic through oral administration. Exhibit 9:(pg. no.32-34) refers to a formulation containing cultivated licorice(Giycyrrhiza glabra Linn.) along with few other ingredients used for the treatment of Palpitation, Depression and Hallucinations through oral_ administration. Exhibit 10:(pg. no.35-37) refers to a formulation containing cultivated licorice(Giycyrrhiza glabra Linn.) along with few other ingredients used for the treatment of sychosis/Insanity/Mania through oral administration. Exhibit 11:(pg. no.38-39) refers to a formulation containing Zizyphus jujuba Linn. Along with few other ingredients used as Sedative/ Anxiolytic through oral administration. The exhibits 1-4, 12 straight forwardly direct the person skilled towards the instant application. The only difference between exhibit 12 &, the composition in instant application is for use in the treatment of anxiety and not depression. A skilled person would be motivated to reach the instant application with exhibit 12 alone or in combination with the other exhibits 1-4 cited herein. Cited exhibits 5, 6 refer to use of liquorice alone, Cited prior art 7 refer to use of jujube alone, and prior art 8, 11 refer to use of jujube with other ingredients and similarly prior art 9, 10 refer to usage of liquorice with other ingredients to treat psychosis, insanity & mania. Exhibits 5-11 alone or in combo with exhibit 12 and or exhibits 1-4 would provide the skilled person motivation to work around to reach the instant application.”

Full examination report can be referred at 1927-KOLNP-2010.pdf

3. Outcomes of Pre-Grant Opposition & Examination Report

As the outcome of TKDL Pre-Grant Opposition and other documents cited in examination report, the examination is under process and reply is still awaited from the Applicant M/S CHI, YU-FEN & ZHANG, ZUOGUANG/ China.