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 Glycyrrihza glabra (licorice), Allium sativum (garlic), Azadirachta indica (neem), Pichcorhiza kurroa (katuki), Annona Squamosa (sugar apple), Withania Somnifera (asvagandha), Piper betle (paan) and Tinospora Cordifolia (guduchi) as Immuno-potentiator / Immuno-modulator, Anti ageing/Anti oxidant, strength promoting from the books – Madanapalanighantauh by Madanapala (Ayurveda, Exhibit 1), Therayar Venba by Therayar (Siddha, Exhibit 2 & 5), Rajanighantauh by Pandita Narahari (Ayurveda, Exhibit 3), Aavialikkum Amuthamurai Churukkam by Kandasamy Mudaliar (Siddha, Exhibit 4), Brhat Nighantu Ratnakara (Ayurveda, Exhibit 6), Rasaratnakarah by Nityanatha siddha (Ayurveda, Exhibit 7), Chikithsa Rathna Deepam by Kannusamy Pillai (Siddha, Exhibit 8) and Astanga Samgraha by Vagbhata (Ayurveda, Exhibit 9).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 5 & 7 are reproduced below.

“Claims 1-14 are not patentable u/S 3(p) of the Act as the subject matter of claims relate to traditional knowledge. Glycyrrihza glabra, Allium sativum, Azadirachta indica, Picrorhiza kurroa, Annona Squamosa, Withania Somnifera, Piper betle and Tinospora Cordifolia has been used traditionally as Imrnuno-potentiator / Immuno-modulator, Anti ageing/Anti oxidant and strength promoting through oral administration in the Indian system of medicine. Refer TKDL RS 15/45,SS 02/18,RS 8/304, AM 05/2116, SS 02/42, RS/5088, RS 7/39, SK 03/157, RK/99 (Documents enclosed for reference).

Without prejudice to above mentioned objections, Claims lack inventive step u/S 2(1)(ja) of the Act, in view of above mentioned prior art documents. In the instant application an anti-retroviral herbal formulation comprising medicinal herbs like Glycyrrihza glabra, Allium sativum, Azadirachta indica, Picrorhiza kurroa, Annona Squamosa, Withania Somnifera, Piper betle and Tinospora Cordifolia is claimed. Cited prior art documents disclose use of these plants as Immuno-potentiator / Immunomodulator, Anti ageing/Anti oxidant and strength promotors. Irrespective of the method employed for extraction of the active ingredient from the plant, it is evident that the therapeutic effect of the plant and/or extracts is known from the cited prior art documents. It would have been obvious to a person skilled in the art to have extracted active ingredients from the plants known for their therapeutic activity and made a formulation with the motivation that combinations of medicinal plants/extracts would be more effective than each of the medicinal plants when applied separately.”

Full examination report can be referred at 721-CHE-2004.pdf

3. Outcomes of TKDL References in Examination Report

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