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 Justicia adhatoda (Malabar nut), Ocimum sanctum (tulasi), Solanum surattense (nightshade), Glycyrrhiza glabra (licorice), Pluchea lanceolata, Curcuma longa (turmeric), Cinnamomum zeylanicum (cinnamon), Syzygium aromaticum (clove), Saussurea lappa, Sugar and Dryobalanops camphora as Beneficial for throat, Expectoration of mucous / Excision and for the treatment of Diseases of the respiratory system, Respiratory infections (Mild to Severe), Diseases of throat, Cough / Bronchitis, Dry cough, Dyspnoea, Chronic cough, Cough with expectoration, Coryza, Catarrh, Sinusitis, Sore Throat / Throat Pain from the books – Brhat Nighantu Ratnakara (Ayurveda, Exhibit 1, 9 & 16), Caraka Samhita by Agnivesa (Ayurveda, Exhibit 2), Khazaain-al-Advia, Vol II & Vol III by Mohammad Najmul Ghani Khan;, (Unani, Exhibit 3, 6 & 7), Muheet-e-Azam, Vol. IV by Mohammad Azam Khan (Unani, Exhibit 4), Agnipuranama (Ayurveda, Exhibit 5), Arkaprakasah by Lankapatiravana (Ayurveda, Exhibit 8), Yogaratnakarah (Ayurveda, Exhibit 10), Yugi Munivar Vaithya Chinthamani by Yugi (Siddha, Exhibit 11), Siddhabhesajamanimalah by Krsnarama Bhatta (Ayurveda, Exhibit 12), Astanga Samgraha by Vagbhata (Ayurveda, Exhibit 13), Aavialikkum Amuthamurai Churukkam by Kandasamy Mudaliar (Siddha, Exhibit 14) , Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 15), and Anuboga Vaithya Navaneetham by Abdulla Sahib (Siddha, Exhibit 17).

2. Relevant Extract of CGPDTM Examination report

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



“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: RS/4081, D2: BP/1720F , D3:AN2/172B, D4: FA2/73, D5:RS12/422, D6:JA6/1040G, D7:JA6/672S, D8: AK14/46A, D9:RS/4499, D10:RG8/1929O, D11:GPO2/514, D12:RS4/632, D13:RK/229, D14: AM05/281O, D15:RS22/788, D16: RS/4006, D17 :KS01/92.

Claim 1 lacks inventive step u/S 2(1)( ja) of the Act in view of cited documents.

D1:(pg. no.7-9) refers to a formulation containing cinnamon (Cinnamomum zeylanicum Blume) as a single ingredient is Beneficial for throat and used for the treatment of Cough / Bronchitis, Sinusitis.

D2:(pg. no. 10-11) refers to a formulation containing Sacred basil, Holy basil (Ocimum sanctum Linn.) as a single ingredient used for the treatment of Cough/ Bronchitis, Dyspnoea.

D3:(pg. no. 12-13) refers to a formulation containing Sacred basil, Holy basil (Ocimum sanctum Linn.) as a single ingredient used for the treatment of Dry cough and Coryza through oral administration.

D4:(pg.no. 14-15) refers to a formulation containing cultivated licorice (Glycyrrhiza glabra Linn.) as a single ingredient used for the treatment of Cough / Bronchitis, Coryza and Catarrh through oral administration.

D5:(pg. no. 16-17) refers to a formulation containing camphorweed (Pluchea lanceolata Oliv. & Hiern / Alpinia galanga(Linn.)Wilid.) and granular sugar used for the treatment of Cough / Bronchitis through oral administration.

D6:(pg. no. 18-19) refers to a formulation containing Curcuma longa as a single ingredient used for the treatment of Cough / Bronchitis through oral administration.

D7:(pg.no.20-21) refers to a formulation containing clove.(Syzygium aromaticum (Linn.) Merr. & L.M. Perry) as a single ingredient used for the treatment of Sore Throat/ Throat Pain through oral administration.

D8:(pg.no. 22-23) refers to a formulation containing saw-wort (Saussurea lappa Clarke) as a single ingredient used for the treatment of Cough /bronchitis through oral administration.

D9:(pg. no. 24-26) refers to a formulation containing Justicia adhatoda as a single ingredient used for. Expectoration of mucous / Excision and for the "treatment of Cough / Bronchitis, Dyspnoea.

D10:(pg. no.27-28) refers to a formulation containing nightshade (Solanum surattense Burm. F. Syn.: S. xanthocarpum Schrad. & Wendl) as a single ingredient used for the treatment of Cough /Bronchitis through oral administration.

D11:(pg. no.29-31) refers to a formulation containing Justicia adhatoda, Solanum surattense and Ocimurn sanctum as a compound formulation used for the treatment of diseases of respiratory system through oral administration.

D12:(pg. no. 32-33) refers to a formulation containing Justicia adhatoda and Curcuma longa as a compound formulation used for the treatment of Dry, cough through oral administration.

D13:(pg. no.34-36) refers to a formulation containing Solanum surattense, Saccharum officinarum and Glycyrrhiza glabra along with one other ingredient used as Beneficial for throat through oral administration. "

D14:(pg.no. 37-39) refers to a formulation containing Syzygium aromaticum , Glycyrrhiza glabra, Cinnamomum zeylanicum along with few other ingredients usedfor the treatment of Respiratory infections (Mild to Severe) through oral administration.

D15:(pg. no. 40-42) refers to a formulation containing Syzygium aromaticum along with few other ingredients used for Expectoration of mucous / Excision in cough with expectoration and for the treatment of Bronchitis, Dyspnoea, Chronic cough Dry cough through oral administration.

D16:(pg. no. 43-44) refers to a formulation containing Borneo camphor (Dryobalanops camphora) as a single ingredient used for the treatment of Sinusitis.

D 17:(pg.no. 45-48) refers to a formulation containing Solarium surattense, Justicia adhatoda, Cinnamomum zeylanicum, Dryobalanops camphora, Syzygium aromaticum, Glycyrrhiza glabra and Granular sugar along with few other ingredients used for the treatment of Cough with expectoration, Cough/Bronchitis through oral administration.

It would have been obvoius to a person skilled in the art to have arrived at the instantly claimed composition from the teachings of the prior art documents.”

Full examination report can be referred at 1114-CHE-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 SINGH ADITYA NARAYAN / India.