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 Oryza sativa (rice) for the treatment of Bronchial asthma, Cough / Bronchitis, Phlegmetic Cough, acute diarrhoea, Stomatitis, all types of Stomatitis of Children, Urticaria, Urticaria/ Allergic rashes, Erythema/ a type of urticaria, Rhinitis, Angina pectoris, Gastritis, Conjunctivitis and Opthalmia neonatorum or Acute conjunctivitis of infants from the books – Rajanighantauh by Pandita Narahari (Ayurveda, Exhibit 1), Kaiyadevanighantau by Kaiyadeva (Ayurveda, Exhibit 2), Muheet-e-Azam Vol. II by Mohammad Azam Khan (Unani, Exhibit 3 & 14), Khazaain-al-Advia, Vol III by Mohammad Najmul Ghani Khan (Unani, Exhibit 4), Miftaah-al-Khazaain by Kareem Bakhsh (Unani, Exhibit 5), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani, Exhibit 6), Vaidyamanorama by Kali Dasa (Ayurveda, Exhibit 7), Qaraabaadeen Qaadri by Mohammad Akbar Arzani (Unani, Exhibit 8), Rasakamadhenu Samhita by Cudamani (Ayurveda, Exhibit 9), Brhat Nighantu Ratnakara - Compiled by Gangavisnu Srikrsna Dasa (Ayurveda, Exhibit 10), Ilaaj-al-Amraaz by Mohammad Shareef Khan (Unani, Exhibit 11 & 13) and Ayurveda Sarasamgrahah (Ayurveda, Exhibit 12).

2. Relevant Extract of CGPDTM Examination report

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

“Objections:

Subject matter of the claims does not constitute an invention u/s 2(1) (j) as the claims lack novelty and inventive step in view of cited documents:

D8: Formulations retrieved from Traditional Knowledge Digital Library

1. Formulation name: Kumkuma Sali Guna [formulation ID: RS8/1048] published in Pandita Narahari; Rajanighantauh - Edited with Hindi Commentary by lndradeo Tripathi; Krishnadas Academy, Varanasi, Edn. 2nd 1998 Pg 537 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) as a single ingredient used for the treatment of Acute diarrhoea. Mode of administration is as directed by physician.

2. Formulation name: Kalamasali Gunaah [formulation ID: RS6/611] published in Kaiyadeva; Kaiyadevanighantau - (Pathyapathyavibodhakah) Edited and translated by P.V. Sharma and Guru Prasad Sharma, Chaukhambha Orientalia, Varanasi, Edn. 1st, 1979 Pg 303 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) as a single ingredient used for the treatment of Cough I Bronchitis and acute diarrhoea. Mode of administration is as directed by physician.

3. Form name: Chawal Barae Surfa Wa Humma [formulation ID: MH 4/116B] published in Mohammad Azam Khan; Muheet-e-Azam Vol. II ( Part I) (19th century AD), Matba Nizami, Kanpur, 1895 AD Pg 57 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) as a single ingredient used for the treatment of Cough I Bronchitis through oral administration.

4. Formulation name: Joshaanda Bara-e- Waja-ul- Medah [formulation ID: JA6/579F] published in Mohammad Najmul Ghani Khan; Khazaain-al-Advia, Vol Ill (20th century AD), Nadeem Yunus Printer Sheikh Mohd Basheer & Sons, Lahore, 1926 AD Pg 592 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with one other ingredient used for the treatment of Gastritis through oral administration.

5. Formulation name: Dawa Bara-e- Niswar [formulation ID: NA3/1245] published in Kareem Bakhsh; Miftaah-al-Khazaain (20th century AD), Dar-al- Kutub Rafeeq-al- Atibba wal Hakeem, Lahore, 1930 AD Pg 561 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with one other ingredient used for the treatment of Conjunctivitis through oral administration.

6. Formulation name: Zaroor-e-qula-e-surkh-3 [formulation ID: NA4/2197] published in Mohammad Najmul Ghani Khan; Qaraabaadeen Najm-al-Ghani (20th century AD), Munshi Nawal Kishore, Lucknow, (Second Edition) 1928 AD Pg 353 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredients used for the treatment of all types of Stomatitis of Children through local application.

7. Formulation name: Mastu Haritaki Yoga [formulation ID: RS14/351B] published in Kali Dasa; Vaidyamanorama; - with Hindi translation : Central Council for Research m Ayurveda & Siddha,Govt. of India, New Delhi, Edn. 2005 [Time of origin 13th century] Pg 87 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredients used for the treatment of Opthalmia neonatorum or Acute conjunctivitis of infants through local application.

8. Formulation name: Majoon Barmaki [formulation ID: MH5/942] published in Mohammad Akbar Arzani; Qaraabaadeen Qaadri (17th century AD), Ahmadi Publication, Delhi, 1968 AD Pg 134 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredients used for the treatment of Bronchial asthma due to Cough/Bronchitis through oral administration.

9. Formulation name: Sitapitte Udvartana [formulation ID: AK9/987] published in Cudamani; Rasakamadhenu Samhita - Edited by Jivaramakalidasa Sastri, Part 4, Chaukhambha Publishers, Varanasi, Edn. 1st 1992 Pg 322 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with one other ingredient used for the treatment of Urticaria through local application.

10. Formulation name: Sitapittapathyah [formulation ID: SL/348] published in Brhat Nighantu Ratnakara - Compiled by Gangavisnu Srikrsna Dasa , Translated by Sri Dattarama Srikrsnalala Mathura; Vol.-3 (Part VI), edn. 1996, Khemaraja Srikrsnadas Prakasana, Mumbai-4 [This book contains back references from 1000 B.C.to 20th century] Pg 1315 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredient used for the treatment of Urticaria, Urticaria/ Allergic rashes, Erythema/ a type of urticaria through oral administration.

11. Formulation name: Habb Bara-e- Surfa Ratubi [formulation ID: MH1/1294] published in Mohammad Shareef Khan; Ilaaj-al-Amraaz (18th century AD), Afzal-al- Matabe, Barqi Press, Delhi, 1921 AD page 104 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredient used for the treatment of Cough/ Bronchitis, Phlegmetic Cough and Bronchial asthma through oral administration.
12. Formulation name: Madhukadi Hima [formulation ID: RS 22/942] published in Ayurveda Sarasamgrahah - Shri Baidyanath Ayurveda Bhavan Limited, Calcutta, Edn. 2003 page 715 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredients used for the treatment of Rhinitis through oral administration.

13. Formulation name: Zaroor Bara-e- Qulaa-e- Dahan [formulation ID: MH1/984] published in Mohammad Shareef Khan; Ilaaj-al-Amraaz (18th century AD), Afzal-al- Matabe, Barqi Press, Delhi, 1921 AD Pg 85 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredient used for the treatment of Stomatitis. Mode of administration is as directed by physician.

14. Formulation name: Chawal Barae Surfa Wa Humma [formulation ID: MH4/116B] published in Mohammad Azam Khan; Muheet-e-Azam Vol. 11 (Part I) (19th century AD), Matba Nizami, Kanpur, 1895 AD Pg 57 refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredient used for the treatment of Cough/ Bronchitis, Angina pectoris through oral administration.

Both the compounds pelargonidin and cyaniding glycoside are well known in prior art and their use in treatment of asthma and allergic diseases is also disclosed in the cited documents hence the claims lack novelty as composition prepared by the known compounds extracted from a new source and using them for treatment of known diseases cannot be considered novel. In view of the cited documents D1-D8 it is obvious for a person skilled in the art to use the teachings of said documents along with the traditionally known properties of the Oryza sativa, which is known for the treatment of allergic diseases, so the use of the active component of said plant independently or in combination cannot be considered as inventive.

(i) Claims 1-3 fall within the scope of such clause (p) of section 3 of Indian Patents Act as the claimed invention relates to mere use of active component of Oryza sativa whose medicinal properties were well known and prior used as part of teachings of traditional knowledge.”

Full examination report can be referred at 7124-DELNP-2008.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).