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 Apium graveolens (celery), Syzygium aromaticum (clove), Amomum subulatum, Elettaria cardamomum (cardamom), Acorus calamus, Piper nigrum (black pepper), Piper longum (Long Pepper) and Zingiber officinale(ginger) for the treatment of Weakness of Stomach, Dyspepsia/Loss of appetite, Colic of abdomen, Nausea, Gastric dyscrasia, Gastralgia, Flatulence, diseases of abdomen, indigestion and used as Digestive, Stomachic, Appetizer, carminative and Laxative from the books – Ilaaj-al-Amraaz by Mohammad Shareef Khan (Unani, Exhibit 1 & 7), Dhanvantarinighantauh by Mahendra Bhaugika (Ayurveda, Exhibit 2), Qaraabaadeen Qaadri by Mohammad Akbar Arzani (Unani, Exhibit 3 & 4), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani, Exhibit 5) and Rasatantrasarah Evam Siddhaprayogasamgrahah part II (Ayurveda, Exhibit 6).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 1, 2 & 3 are reproduced below.

“Objections:

Claim 1 is not patentable u/S 3(p) of the Patents Act, 1970 as it relates to traditional knowledge. Apium graveolens Linn, Syzygium aromaticum, Amomum subulatum, Elettaria cardamomum, Acorus calamus, Piper nigrum, Piper longum, Zingiber officinale, Puffed sugar drops have been used for the treatment of Weakness of Stomach, Dyspepsia/Loss of appetite, Colic of abdomen, Nausea, Gastric dyscrasia, Gastralgia, Flatulence, diseases of abdomen, indigestion and used as Digestive, Stomachic, Appetizer, carminative and Laxative through oral administration in the Indian systems of Medicine.
Refer enclosed TKDL documents D1: Mohammad Shareef Khan; llaaj-al-Amraaz (18th century AD), Afzal-al- Matabe, Barqi Press, Delhi, 1921 AD Pg, 159 Formulation ID: MH 1 / 1856 .Formulation Name: Ramehran.
D2: Mahendra Bhaugika; Dhanvantarinighantauh - Edited by P.V.Sharma; Translated by- Guru Prasad Sharma; Chaukhambha Orientalia, Varanasi,Edn. 3rd, 2002, Pg 261 Formulation ID: AK12/701 Formulation Name: Trikatu Guna.
D3: Mohammad Akbar Arzani; Qaraabaadeen Qaadri (17th century AD), Ahmadi Publication, Delhi, 1968 AD, Pg 186 Formulation ID: MHS/1263 Formulation Name: Sharbat-e- Maebah.
D4: Mohammad Akbar Arzani; Qaraabaadeen Qaadri (17th century AD), Ahmadi Publication, Delhi, 1968 AD, Pg 172 Formulation ID: MH5/ 1 156 Formulation Name: Dawa-e-dard-e- Me Da.
D5: Mohammad Najmul Ghani Khan; Qaraabaadeen Najm-al-Ghani (20th century AD), Munshi Nawal Kishore, Lucknow, (Second Edition) 1928 AD, Pg 703, Formulation ID: NA4/4551 Formulation Name: Majoon Muqawwi.
D6: Rasatantrasarah Evam Siddhaprayogasamgrahah;- part 11; Krishan Gopal Ayurveda Bhawan;Edn 8th;1990,[This book contains back references from 1000 B.C.to 20th century], Pg 397.
D7: Mohammad Shareef Khan; Ilaaj-al-Amraaz (18th century AD), Afzal-al- Matabe, Barqi Press, Delhi, 1921 AD, Pg 154 Formulation ID: MH 1/1801 Formulation Name: Jawarish Naarmushk- Mushil Formulation ID: RS21 /471 Formulation Name: Hapusadicurna.

Not withstanding above mentioned objections, Claim 1 lacks inventive step u/S 2(1)( ja ) in view of cited prior art documents. D1:(pg. no. 04-09) refers to a formulation containing Apium graveolens Linn, Syzygium aromaticum, Elettaria cardamomum, Amomum subulatum, Acorus calamus, Piper nigrum, Piper longum, Zingiber officinale, Puffed sugar drop along with few other ingredients used for the treatment of Weakness of Stomach through oral administration.
D2:(pg. no. 10-11) refers to a formulation containing Zingiber officinale Roscoe, Piper nigrum Linn., Piper longum Linn. along with few other ingredients used for thetreatment of Dyspepsia/Loss of appetite and Colic of abdomen through oral administration.
D3:(pg. no. 12-14) refers to a formulation containing Piper nigrum Linn., Piper longum, Zingiber officinale Roscoe, Elettaria cardamomum (Linn.), Amomum subulatum along with few other ingredients used as Stomachic, Digestive and used for thetreatment of Diarrhoea, Nausea and Gastric dyscrasia through oral administration.
D4:(pg. no. 15-17) refers to a formulation containing Zingiber officinale Roscoe, Piper nigrum Linn., Piper longum Linn., Apium graveolens Linn along with few other ingredients used for the treatment of Gastralgia, Flatulence and indigestion through oral administration.
D5:(pg. no. 18-20) refers to a formulation containing Zingiber officinale Roscoe and Apium graveolens along with few other ingredients used as Stomachic, Appetizer,carminative and used for the treatment of Dyspepsia/Loss of appetite through oral administration.
D6:(pg. no. 21-24) refers to a formulation containing Piper nigrum Linn., Acorus calamus Linn. and Piper longum along with few other ingredient used as Laxative, Appetizer and used for the treatment of Diseases of abdomen, Dyspepsia/Loss of appetite and Indigestion through oral administration.
D7:(pg. no. 25-27) refers to a formulation containing Zingiber officinale Roscoe, Piper nigrum, Piper longum, Elettaria cardamomum, Granular sugar along with few other ingredients used as Laxative, carminative and for the treatment of colic through oral administration. Apium graveolens Linn, Syzygium aromaticum, Amomum subulatum, Elettaria cardamomum, Acorus calamus; Piper nigrum, Piper longum, Zingiber officinale, Puffed sugar drops have been used for the treatment of Weakness of Stomach, Dyspepsia/Loss of appetite, Colic of abdomen, Nausea, Gastric dyscrasia, Gastralgia, Flatulence, diseases of abdomen, indigestion and used as Digestive, Stomachic, Appetizer, carminative and Laxative through oral administration in the Indian systems of Medicine, since long, as is evident from exhibits cited from the books namely, Ilaaj-al-Amraaz by Mohammad Shareef Khan (Unani, D1: pg.no. 04-09), Dhanvantarinighantauh by Mahendra Bhaugika (Ayurveda, D2: pg. no. 10-11), Qaraabaadeen Qaadri by Mohammad Akbar Arzani (Unani, D3: pg. no. 12-14), Qaraabaadeen Qaadri by Mohammad Akbar Arzani (Unani, D4: pg. no.15-17), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani, D 5: pg. no. 18-20), Rasatantrasarah Evam Siddhaprayogasamgrahah part II (Ayurveda, D6: pg. no. 21-24) and llaaj-al-Amraaz by Mohammad Shareef Khan (Unani, D7: pg. no. 25-27).
Combination of plants with known-therapeutic effect with further plants with the same known-therapeutic agents wherein all plants are previously known for treating the same disease is , considered to be an obvious combination. Therefore, such claims cannot be considered inventive. In this regard, it would normally be expected that such combinations of medicinal plants would be more effective than each of the medicinal plants when applied separately (additive effect).”

Full examination report can be referred at 1109-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, Application Abandoned U/S 21(1)