Ref: Examiner(s) Comments in the Examination Report Dated: 27.03.2014 on TKDL Submission Dated: 17.12.2012 in the context of Patent Application No. 372/KOLNP/2009 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 Andrographis panicultata (Source of Andrographolide), Vitis vinifera (Source of Proanthocyanidin), Fumaria vaillantii, Papaver somniferum (Source of Isoquinoline), Phyllanthus emblica (Source of Anthocyanoside), Cyperus rotundus, Curcuma longa, Santalum album, Zingiber officinale, Cedrus deodara, Inula helenium / Inula racemosa, Aquilaria malaccensis, Curcuma zedoaria, Bamboo manna (Sources of Lactone Sesquiterpene), Albizia lebbeck, Glycyrrhiza glabra (Sourcse of Aglycone), Michelia champaca (Source of Parthenolide), Punica granatum and Woodfordia fruticosa (Sources of Pelargonidin) for the treatment of Immuno suppressive / Emaciating disease, Diseases of abdomen, Stomatitis, Diseases of the mouth, Gastritis, Cancrum oris/Gangrenous stomatitis and as Immuno-potentiator / Immuno-modulator, Analgesic;restoring normal sensation, Gastric cleanser and Anti-inflammatory from the books – Cikitsa kalika by Tisatacharya (Ayurveda, Exhibit 1), Yogacintamani/Sarasangraha by Harshakirti (Ayurveda, Exhibit 2), Anuboga Vaithya Navaneetham, Part - 8 by Abdulla Sahib (Siddha, Exhibit 3), Ayurvedic Formulary of India - Part II by Govt of India (Ayurveda, Exhibit 4), Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 5), Bharata Bhaisajya Ratnakara (Ayurveda, Exhibit 6), Al-Jaam'e-li-Mufradaat-al-Advia-wal-Aghzia, Vol. II by Ziya Al- Din Abdullah Ibn Al- Baitar (Unani, Exhibit 7), Khazaain-al-Advia, Vol. I by Mohammad Najmul Ghani Khan (Unani, Exhibit 8), Rasatantrasarah Evam Siddhaprayogasamgrahah- part II (Ayurveda, Exhibit 9), Muheet-e-Azam Vol. III by Mohammad Azam Khan (Unani, Exhibit 10 & 11), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani, Exhibit 12) and Kitaab-al-Haawi-fil-Tibb,Vol.III by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani, Exhibit 13).

2. Relevant Extract of CGPDTM Examination report

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

“The observations under paragraphs 1 and 2 notwithstanding, amended claims 1-16 attract the provisions of such clause (p) of section 3 of the Act for being traditional knowledge of India and hence are not patentable. In Traditional Knowledge Digital Library (TKDL) there are several references where Andrographis panicultata (Burm.) Nees (source of Andrographolide), Vitis vinifera Linn. (source of Proanthocyanidin), Fumaria vaillantii Loisel., Papaver somniferum Linn. (source of lsoquinoline), Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn. (source of Anthocyanoside), Cyperus rotundus Linn., Curcuma longa, Santalum album Linn., Zingiber officinale Roscoe, Cedrus deodara (D.Don) G.Don, lnula helenium Linn./lnula racemosa Hook., Aquilaria malaccensis Lam. Syn.: A. agallocha Roxb., Curcuma zedoaria (Christm.) Roscoe, Bamboo mannaICurcuma angustifolia Roxb. (sources of Lactone Sesquiterpene), Aibizia lebbeck (Linn.) Benth., Glycyrrhiza glabra Linn. (sources of Aglycone), Michelia champaca Linn. (source of Parthenolide), Punica granatum Linn. and Woodfordia fruticosa (Linn.) Kurz. (sources of Pelargonidin) has been used for the treatment of immune suppressiveIemaciating disease, diseases of abdomen, Stomatitis, diseases of the mouth, Gastritis, Cancrum oris/Gangrenous stomatitis and as immune-potentiatorIimmune-modulator, analgesic; restoring normal sensation, gastric cleanser and anti-inflammatory through oral administration, local application or as directed by physician in the Indian systems of Medicine, since long. Please see the following references: (a) Tisatacharya; Cikitsa kalika, Sanskrit commentary by Candrata & Editing with English Commentary by Priyavrata Sharma, Chaukhambha Surbharati Prakashan, Varanasi, First Edition, 1987, Pages 98-99, Formulation ID: SG/104, Formulation Name: Mahakhadir Ghrta. (b) Harshakirti; Yogacintamani/Sarasangraha, Translated by Dattaram Caube, Khemraj Srikrishnadas, Srrivyankateshwar Press, Mumbai, Edition, November-2006, Page 43, Formulation ID: BD/29, Formulation Name: Adrakpak. (c) Abdulla Sahib; Anuboga Vaithya Navaneetham, Part-8, Ed: Mohammad Abdullah Shahib, Publisher: Thamarai Noolagam, Chennai, (Edn: 2nd, 2002) Page 39, Formulation ID: KS01/43, Formulation Name: Elaathi Chooranam?2. (d) Govt. of India; Ayurvedic Formulary of India - Part II, Govt. of India, Ministry of Health & Family Welfare, Dept. Of I. S. M. & H., New Delhi, Edn. 1st, 2000 [This book contains back references from 1000 B.C.to 20th century], Page 256, Formulation ID: VS/2541, Formulation Name: Nidrodayarasah. It is to be noted herein that a representation under section 25(1) has been filed by Council of Scientific & Industrial Research against the instant application, which shall be communicated to your office in due course.”

Full examination report can be referred at 372-KOLNP-2009.pdf

3. Current status & 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.