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 Berberis aristata (Daruharidra) for the treatment of Osteoarthiritis, Fracture, Diminution of bone tissue, Rheumatism, Gout and Lumbago from the books – Rasaratnakarah by Nityanathasiddhah (Ayurveda, Exhibit 1), Bharata Bhaisajya Ratnakara - Compiled by Naginadasa Chaganalala Saha (Ayurveda, Exhibit 2 & 4), Brhat Nighantu Ratnakara - Compiled by Gangavisnu Srikrsna Dasa (Ayurveda, Exhibit 3), Rasayoga Sagara - Compiled and Translated by Vaidya Pandita Hariprapanna Ji (Ayurveda, Exhibit 5) and Bhavaprakasa by Bhavamisra (Ayurveda, Exhibit 6 & 7).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 5 & 6 are reproduced below.



“Claims 1-14 are not patentable u/S 3(p) of the Act as they pertain to traditional knowledge. Use of Berberis aristata for treatment of osteoporosis, osteoarthritis and bone related disorders is traditionally known. Refer enclosed TKDL document D7:BP/1317, D8: RG/2209, D9:AK/1866.
Claims lack novelty/inventive step in view of prior art documents D1:DATABASE WPI Week 199730 1,3,4,6, Derwent Publications Ltd., London, GB; AN 8,10,11,1997-320467 13,14 & CN 1105584, D2: DATABASE WPI Week 200230. 1,3,4,6, Derwent Publications Ltd., London, GB; AN 8,10,11, 2002-244185 13,14 & HU 0 001 144, D3: DATABASE WPI Week 200127 Derwent Publications Ltd., London, GB; AN 2001-264633 & RU 2162334 , D4: DATABASE WPI Week 200458Derwent Publications Ltd., London,.GB; AN 2002-478438 & CN 1 499 933 , D5: DATABASE WPI Week 200667 Derwent Publications Ltd., London, GB; AN 2006-636136 & CN 1 742 801 , D6:LI HUIYING ET AL: "Effect of.berberine on bone mineral density in SAMP6 as a senile osteoporosis model" BIOLOGICAL & PHARMACEUTICAL BULLETIN (OF JAPAN), PHARMACEUTICAL,SOCIETY OF JAPAN, TOKYO, JP, vol. 26, no. 1,January 2003 (2003-01), pages 110-111, D7:BP/1317, D8: RG/2209, D9:AK/1866

Claims 1-14 lack inventive step u/S 2(1)( ja) in view of cited documents. The use of organic solvent and aqueous extracts of Berberis aristata for treating osteoporosis would have been obvious to a person skilled in the art from the teachings of the cited prior art documents. If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be considered as novel and/or inventive when use of such plants is pre-known as part of teachings of Traditional Knowledge (TK). When the subject-matter of claims relate to extracts of plant materials containing undefined active ingredients, such claims cannot be said to be novel if the use of such plants or plant materials is pre-known as a part of teaching of TK. However, if the claims relate to alkaloids and/or active principles obtained from the plant materials and structures of the said alkaloids and/or active principles are characterized, which do not form the part of the prior art, such claims cannot be said to involve an inventive step, since the use of said plant materials and their therapeutic effects are known from the teaching of TK. Thus, the prior art motivates the person skilled in the art to isolate the individual ingredients such as alkaloids, flavonoids, phyto-steroids, etc.”

Full examination report can be referred at 1196-CHE-2006.pdf

3. Outcomes of Pre-Grant Opposition & Examination Report.

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