Ref: Examiner(s) Comments in the Examination Report Dated: 26.11.2014 on TKDL Submission Dated: 24.09.2012 in the context of Patent Application No. 2242/CHE/2008 at CGPDTM

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 Adhatoda vasica (Malabar nut), Aegle marmelos (Indian bael), Boerhaavia diffusa, Ficus racemosa, Lawsonia inermis (mehndi) and Tamarindus indica (tamarind) for the treatment of haemorrhagic diseases, haemorrhagic diseases of penis, bleeding, Hematuria, Diseases of the kidney, Diseases of the urinary system and used as Haemostyptic from the books – The Ayurvedic Pharmacopoeia of India - Part I, Vol. I by Govt of India (Ayurveda, Exhibit 1), Gadanigrahah by Sodhala (Ayurveda, Exhibit 2), Kitaab-al-Haawi-fil-Tibb, Vol.IV & Vol.X by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani,Exhibit 3 & 4), Sodhalanighantauh by Sodhala (Ayurveda, Exhibit 5), Ayurveda Sarasamgrahah (Ayurveda, Exhibit 6), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani, Exhibit 7), Khazaain-al-Advia, Vol III by Mohammad Najmul Ghani Khan (Unani,Exhibit 8) and Qaraabaadeen Qaadri by Mohammad Akbar Arzani (Unani,Exhibit 9).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 4 & 5 are reproduced below.

“Claims 1-8 are not patentable u/S 3(p) of the Act as they relate to Traditional Knowledge. The claimed herbs are traditionally known for treatment of hematuria.Refer the list of documents with date of publication (PRIOR ART) in enclosed TKDL documents D1: RG/3575, D2:AA10/05A, D3:RG12/1023, D4:BA3/470A, D5: JA6/589Z21, D6: MH5/1979.

Notwithstanding above mentioned objections, Claims 1-8 lack inventive step in view of cited prior art documents D1-D6. The cited documents disclose the claimed herbal ingredients for treatment of hematuria and related disorders.

D1 discloses the use of Justicia adhathoda for treatment of urinary disorders. D2 discloses the use of Aegle marmelos for treatment of hematuria. D3 discloses the use of Boerhavia diffusa against Urinary disease. D4 relates to the use of Tamarindus indicus as a hemostyptic. D5 discloses the use of Ficus racemosa for treatment of diseases of the urinary system. D6 relats to the use of Lawsonia inermis for treatment of Hematuria.
It would have been obvious to a person skilled in the art to have arrived at the instantly claimed composition from the disclosure of prior art documents without the exercise of inventive skill.”

Full examination report can be referred at 2242-CHE-2008.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 SAH, BHUVANESHWAR/ India.