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 (daruhaldi), Azadirachta indica (neem) and Potassium nitrate for the treatment of Piles / Ano rectal mass/Haemorrhoids, Pain associated with Piles/Ano rectal mass / Haemorrhoids, Bleeding piles, Non Bleeding Piles, Severe Hemorrhage associated with Piles/Ano rectal mass / Haemorrhoids from the books – Siddhabhesajamanimalah by Ksnarama Bhatta (Ayurveda,Exhibit 1 & 9), Gadanigrahah by Sodhala (Ayurveda,Exhibit 2), Ilaaj-al-Amraaz by Mohammad Shareef Khan (Unani,Exhibit 3), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani,Exhibit 4 & 6), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani,Exhibit 5), Caraka Samhita by Agnivesa (Ayurveda, Exhibit 7), Siddhayogasamgrahah - Compiled by Yadavji Trikamji Acharya (Ayurveda, Exhibit 8) and Chikithsa Rathna Deepam by Kannusamy Pillai (Siddha, Exhibit 10).

2. Relevant Extract of CGPDTM Examination report

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

“Subject-matter claimed in claim 1 is not patentable u/s 3 (p) of Patents act. Your attention has been drawn to the pregrant opposition filed under section 25(1) of the Act in this application. Exhibit 1:(pg. no. 05-06) refers to a formulation containing Rasaut (Berberis aristata) and Limbodi (Azadirachta indica) for the treatment of Piles / Ano rectal mass / Haemorrhoids through oral administration. Exhibit 2:(pg. no. 07-09) refers to a formulation containing Rasaut (Berberis aristata), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Bleeding piles through oral administration. Exhibit 3:(pg. no. 10-11) refers to a formulation containing Rasaut (Berberis aristata), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Severe Hemorrhage associated with Piles / Ano rectal mass / Haemorrhoids through oral administration. Exhibit 4-.(pg. no, 12-13) refers to a formulation containing Rasaut (Berberis aristata), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Pain associated with Piles I Ano rectal mass I Haemorrhoids through oral administration. Exhibit 5:(pg. no. 14-16) refers to a formulation containing Rasaut (Berberis aristata), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Bleeding piles and Non Bleeding Piles through oral administration. Exhibit 6:(pg. no. 17-19) refers to a formulation containing Rasaut (Berberis aristata), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Piles / Ano rectal mass / Haemorrhoids and Non Bleeding Piles through oral administration. Exhibit 7:(pg. no. 20-22) refers to a formulation containing Rasaut (Berberis aristata), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Bleeding piles through oral administration. Exhibit 8:(pg. no. 23-25) refers to a formulation containing Rasaut (Berberis aristata), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Bleeding piles, Piles / Ano rectal mass / Haemorrhoids through oral administration. Exhibit 9:(pg. no. 26-27) refers to a formulation containing Kalmi Soda (Potassium nitrate), (Rasaut (Berberis aristata) along with few other ingredients used for the treatment of Bleeding piles. Mode of administration is as directed by physician. Exhibit 10:(pg. no. 28-31) refers to a formulation containing Kalmi Soda (Potassium nitrate), Limbodi (Azadirachta indica) along with few other ingredients used for the treatment of Piles / Ano rectal mass / Haemorrhoids through oral administration. The alleged patent application 1512/MUM/2011 claims the usefuilness of a herbal composition comprising Rasot, Limbodi, Kalmi Soda for the treatment of piles as novel. However, Rasot (Berberis aristata), Limbodi (Azadirachta indica), Kalmi Soda (Potassium nitrate) have been used alone or in combination with few other ingredients for the treatment of Piles / Ano rectal mass/Haemorrhoids, Pain associated with Piles/Ano rectal mass 1 Haemorrhoids, Bleeding piles, Non Bleeding Piles, Severe Hemorrhage associated with Piles/Ano rectal mass / Haemorrhoids through oral administration in the indian systems of medicine, since long, as is evident from exhibits cited from the books namely, Siddhabhesajamanimalah by Ksnarama Bhatta (Ayurveda,Exhibit 1:pg. no. 05-06), Gadanigrahah by Sodhala (Ayurveda, Exhibit 2-.pg. no. 07-09), Ilaaj-al-Amraaz by Mohammad Shareef Khan (Unani;Exhibit 3:pg. no. 10-11), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan(Unani,Exhibit 4:pg. no. 12-13), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani,Exhibit 5 :pg. no. 14-16), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani,Exhibit 6 :pg. no. 17-19), Caraka Samhita by Agnivesa (Ayurveda, Exhibit 7:pg. no. 20-22), Siddhayogasamgrahah - Compiled by Yadavji Trikamji Acharya (Ayurveda, Exhibit 8:pg. no. 23-25), Siddhabhesajamanimalah by Krsnarama Bhatta (Ayurveda, Exhibit 9:pg. no. 26-27) and Chikithsa Rathna Deepam by Kannusamy Pillai(Siddha, Exhibit 10 :pg. no. 28-31). In addition to the aforesaid references, some other references also exist in TKDL wherein Rasot (Berberis aristata, Limbodi (Azadirachta indica) Kalmi Soda (Potassium nitrate) have been used alone and in combination with few other ingredients for the treatment of above mentioned indications and actions. Hence the said application 15121MUM/2011 is not novel as per the cited prior art and does not involve any inventive step, therefore cannot qualify for the grant of patent rights. (For details refer exhibits filed with pregrant opposition).”

Full examination report can be referred at 1512-MUM-2011.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 POPATBHAI KARSON PATEL / INDIA.