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 Terminalia chebula(haritaki), Azadirachta indica (neem), Glycyrrhiza glabra(licorice), Leptadenia reticulate, Swertia chirayita, Picrorhiza kurroa, Piper longum (pippali), Piper nigrum(black pepper)., Zingiber officinale (ginger), Tinospora cordifolia (guduchi), Commiphora wightii (guggulu), Curcuma longa (turmeric), Holarrhena antidysenterica , Asparagus racemosus(shatavari)., Withania somnifera (Ashvagandha), Tribulus terrestris (caltrop), Mucuna pruriens., Ocimum sanctum(tulasi)., Pueraria tuberosa, Phaseolus radiatus and Caesalpinia bonducella for the treatment of Immuno suppressive / Emaciating disease, Rheumatism, Cancer/ Carcinoma, Tuberculosis/Pthysis, Influenza, Acute diarrhoea, Cirrhosis of liver, Dysenteric diarrhoea/Haemorrhagic diarrhoea, Cancer/ Carcinoma of Penis and Vagina and as Immuno potentiators/Anti ageing/Anti oxidant and Immuno-potentiator / Immuno-modulator from the books – Vangasena by Vangasena (Ayurveda, Exhibit 1), Basavarajiyam by Basavaraja (Ayurveda, Exhibit 2), Sahastrayoga by Govt of India (Ayurveda, Exhibit 3), Astanga Hrdaya by Vagabhata (Ayurveda, Exhibit 4), Bharata Bhaisajya Ratnakara (Ayurveda, Exhibit 5), Gadanigrahah by Sodhala (Ayurveda, Exhibit 6 & 13), Yogaratnakarah (Ayurveda, Exhibit 7), Chimittu Rathna Churukkam by I.N.A (Siddha, Exhibit 8), Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 9), Sahastrayoga by Govt of India (Ayurveda, Exhibit 10), Anuboga Vaithya Navaneetham, Part - 8 by Abdulla Sahib (Siddha, Exhibit 11), Agathiyar Vaithya Kaviyam - 1500 by Agasthiyar (Siddha, Exhibit 12), Chikithsa Rathna Deepam by Kannusamy Pillai (Siddha, Exhibit 14), Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 15) and Miftaah-al-Khazaain by Kareem Bakhsh (Unani, Exhibit 16).

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.

“Claims 1-16 are not allowable under section 3(p) of the Act. Your attention has been drawn to the pregrant opposition filed under section 25(1) of the Act in this application. Documents & Reference I.Vangasena; Vangasena - Commentator Shaligram Vaisya, Edited Shankar latji Jain; Khemraj Shrikrishna Das Prakashan, Bombay, Edn. 1996 Pg 388-390 Formulation ID: AK I i / 1517 Formulation Name: Suryaprabhagutika 2.Basavaraja; Basavarajiyam-Chaukhambha Sanskrit Pratisthan, Delhi;Edn. 1st Reprint ;2005 Time of origin 15th century ] Pg 42 Formulation ID: AK/291 Formulation Name: Sudarsanacurnam 3.Govt of India; Sahastrayoga - Translated by D.V. Panditarao : Central Council for Research in Ayurveda & Siddha, New Delhi, 1990. [This book contains back references from 1000 B.C.to 20th century] Pg 238 Formulation ID: VS/3567 Formulation Name: Madanakamesvarolehah / Caturjatarasayanam 4.V5gabhata; Astanga iirdaya - (commentary by Arunadutta) edited by Bhisagacarya Harisastri Paradakara vaidya Chaukhamba Orientalia, Varanasi, edn. 8th, 1998, [Time of origin 5th century ] Pg 597 Formulation ID: RS23/464A Formulation Name: Vasisthaharitaki Avaleha 5.-; Bhfirata Bhaisajya Ratnakara Compiled by Naginadasa Chaganalila S5ha Translated by Gopinath Gupta - Vol. -V : B. Jain Publishers, New Delhi, Edn. 2nd. Reprint, August 1 999. [This book contains back references from 1 000 B.C.to 20th century] Pg 769 Formulation ID: I-IG/2 3 14 Formulation Name: KSme?vararasah (02) 6.Sodhala; Gadanigrahah ed,Ganga Sahaya Pandeya & Com.- Indradeva Tripathi,Part- i (Prayoga Khanda) Chaukhamba Sanskrit Sansthan, Varanasi, Ed. 3rd 1 999 Pg 2 13 Formulation ID: HG/2332 Formulation Name: Kutherakadyamcurnam 7.-; Yogaratnakarah - Commentary by Laksmipatis5strl, Edited by Brahmasankara Sastri, Chaukhamba Sanskrit Sansthan(Varanasi) Ed. 7th 2002 Pg 382 Formulation ID: BP/450 Formulation Name: Guducyadimodakah 8.I.N.A; Chimittu Rathna Churukkam, Ed: Vaidhilinga Dhesikar, Publisher: Sakalakala Nilayam Press, Chennai. (Edn: 1st 1 887) Pg 42-44 Formulation ID: GPI 3/40 Formulation Name: Kungumapoo Legyam 9.; Rasatantrasarah Evam Siddhaprayogasamgrahah;- part fl; Krishan Gopal Ayurveda Bhawan;Edn 8th; 1990 [This book contains back references from 1000 B.C.to 20th century) Pg 72-73 Formulation ID: RS21 /69 Formulation Name: Sarvajvarahara Lauha I O.Govt of India; Sahastrayoga - Translated by D.V. Panditarao : Central Council for Research in Ayurvcda & Siddha, New Delhi, 1 990. [This book contains back references from 1000 B.C.to 20th century] Pg 189 Formulation ID: VS/3437 Formulation Name: Narasirtthacurnam I 1.Abdulla Sahib; Anuboga Vaithya Navaneetham, Part - 8, Ed:Mohammad Abdullah Shahib, Publisher: Thamarai Noolagam, Chennai. (Edn: 2nd, 2002) Pg 90-92 Formulation ID: KSO I/ 112 Formulation Name: Narasimma Ilagam 1 2.Agasthiyar; Agathiyar Vaithya Kaviyam - 1500, Ed:S.P. Ramachandran, Publisher:Thamarai Noolagam, Chennai. (Edn: 2nd. Reprint, Aug. 2001). Pg 57,58 Formulation ID: GPO 3/57 Formulation Name: Kukkil Nei-2 1 3Sodhala; Gadanigrahah ed,Ganga Sahaya Pandeya & Com.- Indradeva Tripathi,Part- I (Prayoga Khanda) Chaukhamba: Sanskrit Sansthan, Varanasi, Ed. 3rd 1999 Pg 302-303 Formulation ID: AK2/487 - Formulation Name: Eladyaavalcha 1 4.Kannusamy Pillai ; Chikithsa Rathna Deepam, Ed: C.Kannuswami Pillai, Publisher: B.Rathna Nayakar & sons, "l"hirumagal Achagam, Chennai. (Edn: 1956) Pg 175,176 Formulation ID: SK03/165 Formulation Name: Visha Raaja Pangha Thylam 1 5.Govinda Dasa; Bhaisajya Ratnavali - Edited by Rajeshvaradutia Shastri, Translated by Ambikaduttashastri : Chaukhamba Sanskrit Sansthan, Varanasi, Edn. 1 4th, 2001. [This book contains back references from 1 000 B.C.to I8th century] Pg 550 Formulation ID: AK/2436 Formulation Name: Mahamrtyuiijayalauham 1 6.Karcem Bakhsh; Miliaah-al-Khazaain (20th century AD), Dar-al- Kutub Rafceq-al- Atibba wal llakeem, Lahore, 1 930 AD Pg 59-60 Formulation ID: NA3/22D Formulation Name: Scemab Exhibit 1:(pg. no.08-17) refers to a formulation containing Terminalia chebula Retz., Azadirachta indica A. Juss., Glycyrrhiza glabra Linn., Leptadenia reticulata Wight & Arn., Andrographis panicultata (Burm.) Nees / Swertia chirayita (Roxb. ex Flem.) Karst., Picrorhiza kurroa, Piper longum Linn., Piper nigrum Linn., Zingiber officinale Roscoe, Tinospora cordifolia Miers, Withania somnifera (Linn.) Dun. and Commiphora wightii Bhandari Syn.: C. mukul ( Hook. ex Stocks) Engl. along with few other ingredients used for the treatment of Immuno suppressive / Emaciating disease, Rheumatism and Tuberculosis/Pthysis through oral administration. Exhibit 2:(pg. no.18-22) refers to a formulation containing Curcuma longa, Terminalia chebula Retz., Zingiber officinale Roscoe, Azadirachta indica A. Juss., Piper longurn Linn., Glycyrrhiza glabra Linn., Holarrhena antidysenterica (Roxb. ex Flem.) Wall, ex DC., Asparagus racemosus Wilid., Piper nigrum Linn., Tinospora cordifolia Miers, Picrorhiza kurroa and Swertia chirayita (Roxb. ex Flem.) Karst. along with few other ingredients used for the treatment of Influenza through oral administration. Exhibit 3:(pg. no.23-29) refers to a formulation containing Withania somnifera (Linn.) Dun., Tribulus terrestris Linn., Glycyrrhiza glabra Linn., Terminalia chebula Retz., Zingiber officinale Roscoe, Piper nigrum Linn., Piper longum Linn., Picrorhiza kurroa, Tinospora cordifolia Miers, Mucuna pruriens (Linn.) DC. Syn.: M. prurita Hook., Pueraria tuberosa DC. and Asparagus racemosus Willd. along with few other ingredients used for the treatment of Tuberculosis/Pthysis and Acute diarrhoea through oral administration. Exhibit 4:(pg. no.30-35) refers to a formulation containing Tribulus terrestris Linn., Curcuma longa, Piper longum Linn., Withania somnifera (Linn.) Dun., Mucuna pruriens (Linn.) DC. Syn.: M. prurita Hook., Tinospora cordifolia Miers, Pueraria tuberosa DC., Holarrhena antidysenterica (Roxb. ex Flem.) Wall. ex DC., Asparagus racemosus Willd., Azadirachta indica A. Juss. and Terminalia chebula Retz. along with few other ingredients used as Immuno potentiators/Anti ageing/Anti oxidant through oral administration. Exhibit 5:(pg. no.36-40) refers to a formulation containing Withania somnifera (Linn.,) Dun., Tinospora cordifolia Miers, Pueraria tuberosa DC., Tribulus terrestris Linn., Asparagus racemosus Willd., Zingiber officinale Roscoe, Piper nigrum Linn., Piper longum Linn., Mucuria pruriens (Linn.) DC. Syn.: M. prurita Hook. and Terminalia chebula Retz. along with few other ingredients used for the treatment of Immuno suppressive / Emaciating disease, Acute diarrhoea and as Immuno potentiators/Anti ageing/Anti oxidant through oral administration. Exhibit 6:(pg. no.41-45) refers to a formulation containing Ocimum sanctum Linn., Terminalia chebula Retz., Zingiber officinale Roscoe, Piper longum Linn., Piper nigrum Linn., Azadirachta indica A. Juss., Holarrhena antidysenterica (Roxb. ex Flem.) YVall. ex DC., Picrorhiza kurroa, Tinospora cordifolia Miers and Swertia chirayita (Roxb. ex Flem.) Karst. along with few other ingredients used as Immuno- potentiator / Immuno-modulator through oral administration. Exhibit 7:(pg. no.46-50) refers to a formulation containing Tinospora cordifolia Miers, Piper nigrum Linn., Piper longum Linn., Zingiber officinale Roscoe, Glycyrrhiza glabra Linn., Withania somnifera (Linn.) Dun., Asparagus racemosus Willd., Tribulus terrestris Linn. and Mucuna pruriens (Linn.) DC. Syn.: M. prurita Hook. along with few other ingredients used for the treatment of Immuno suppressive / Emaciating disease and as Immuno potentiators/Anti ageing/Anti oxidant through oral administration. Exhibit 8:(pg. no.51-58) refers to a formulation containing Tribulus terrestris Linn., Ocimum sanctum Linn., Piper longum Linn., Terminalia chebula Retz., Zingiber officinale Roscoe, Piper nigrum Linn., Glycyrrhiza glabra Linn. and Picrorhiza kurroa along with few other ingredients used for the treatment of Tuberculosis / Pthysis and Immuno-potentiator / lmmuno-modulator as through oral administration. Exhibit 9:(pg. no.59-63) refers to a formulation containing Terminalia chebula Retz., Zingiber officinale Roscoe, Piper nigrum Linn., Piper longum Linn., Swertia chirayita (Roxb. ex Flem.) Karst., Picrorhiza kurroa, Glycyrrhiza glabra Linn. and Holarrhena antidysenterica (Roxb. ex Flem.).Wall. ex DC. along with few other ingredients used for the treatment of Influenza, Rheumatism and Tuberculosis / Pthysis through oral administration. Exhibit 10:(pg. no.64-67) refers to a formulation containing Asparagus racemosus Willd., Tribulus terrestris Linn., Tinospora cordifolia Miers, Zingiber officinale Roscoe, Piper nigrum Linn., .Piper longum Linn. and Pueraria tuberosa DC. along with few other ingredients used for the treatment of Tuberculosis / Pthysis through oral administration. Exhibit 11:(pg. no.68-72) refers to a formulation containing Asparagus racemosus Willd., Tribulus terrestris Linn., Tinospora cordifolia Miers, Zingiber officinale Roscoe, Piper nigrum Linn., Piper longum Linn. and Glycyrrhiza glabra Linn. along with few other ingredients used for the treatment of Cancer/ Carcinoma of Penis and Vagina through oral administration. Exhibit 12:(pg. no.73-76) refers to.a formulation containing Azadirachta indica A. Juss., Tinospora cordifolia Miers, Piper longum Linn., Curcuma longa, Piper nigrum Linn., Picrorhiza kurroa and Terminalia chebula Retz. along with few other ingredients used for the treatment of Cancer/ Carcinoma through oral, administration. Exhibit 13:(pg. no.77-80) refers to. a formulation containing Terminalia chebula Retz., Azadirachta indica A. Juss., Zingiber officinale Roscoe, Piper nigrum Linn., Piper longum Linn. and Vigna radiata (Linn.) R.Wilcz. Syn.: Phaseolus radiatus Linn. along with few other ingredients used for the treatment of Tuberculosis / Pthysis and as Immuno. potentiators/Anti ageing/Anti oxidant through - oral administration. Exhibit 14:(pg. no.81-84) refers to a formulation containing Terminalia chebula Retz., Andrographis panicultata (Burm.) Nees / Swertia chirayita (Roxb. ex Flem.) Karst., Tinospora cordifolia Miers, Azadirachta indica A. Juss. and Piper nigrum Linn. along with few other ingredients used for the treatment of Cancer/ Carcinoma through oral administration. Exhibit 15:(pg. no.85-90) refers to a formulation containing Picrorhiza kurroa, Curcuma longa, Holarrhena antidysenterica (Roxb. ex Flem.) Wall. ex DC., Terminalia chebula Retz., Zingiber officinale Roscoe and Tinospora cordifolia Miers along with few other ingredients used for the treatment of Cirrhosis of liver through oral administration. Exhibit 16:(pg. no.91-93) refers to a formulation containing Caesalpinia bonducella Flem. as a single ingredient used for the treatment of Dysenteric diarrhoea/Haemorrhagic diarrhoea through oral administration. The alleged patent application 1047/MUM/2008 claims the usefulness of an immunomodulator herbal formulation comprising an extract of at least one plant selected from Cressa eretica, Leptadenia reticulata, Tinospora cordifolia, Picrorrhiza kurrova, Chlorophytum borivillianum, Zingiber officinale, Tribulus terrestris, Caesalpinia bondoc, Asparagus racemosus, Piper longum, Sweretia chiraita, Phaceolus radiatus, Piper nigrum, Withania somnifera, Ocimum sanctum, Mucuna pruriens, Commiphora wightii, Glycyrrhiza glabra, Holarrhena antidysentrica, Pueraria tuberosa, Curcuma longa, Azadirachta indica, Terminalia chebula or a combination thereof for the treatment of Acquired Immune Deficiency Syndrome, flu, tuberculosis, hepatitis, cirrhosis, diarrhoea, cancer and immunodeficiency conditions. However Terminalia chebula Retz., Azadirachta indica A. Juss., Glycyrrhiza glabra Linn., Leptadenia reticulata Wight & Arn., Swertia chirayita (Roxb. ex Flem.) Karst., Picrorhiza kurroa, Piper longum Linn., Piper nigrum Linn., Zingiber officinale Roscoe, Tinospora cordifolia Miers, Commiphora wightii Bhandari Syn.: C. mukul ( Hook. ex Stocks) Engl., Curcuma longa, Holarrhena antidysenterica (Roxb. ex Flem.) Wall. ex DC., Asparagus racemosus Willd., Withania somnifera (Linn.) Dun., Tribulus terrestris Linn., Mucuna pruriens (Linn.) DC. Syn.: M. prurita Hook., Ocimum sanctum Linn., Pueraria tuberosa DC., Phaseolus radiatus Linn. and Caesalpinia bonducella Flem. has been used for the treatment of Immuno suppressive / Emaciating disease, Rheumatism, Cancer/ Carcinoma, Tuberculosis/Pthysis, Influenza, Acute diarrhoea, Cirrhosis of liver, Dysenteric diarrhoea/Haemorrhagic diarrhoea, Cancer/ Carcinoma of Penis and Vagina and as Immuno potentiators/Anti ageing/Anti oxidant and Immuno-potentiator / Immuno-modulator through oral administration, in the Indian system of medicine, since long, as is evident from exhibits cited from the books namely Vangasena by Vangasena(Ayurveda, Exhibit 1: pg. no.08-17), Basavarajiyam by Basavaraja(Ayurveda, Exhibit 2: pg. no.18-22), Sahastrayoga by Govt of India(Ayurveda, Exhibit 3: pg. no.23-29), Astanga Hrdaya by Vagabhata(Ayurveda, Exhibit 4: pg. no.30-35), Bharata Bhaisajya Ratnakara(Ayurveda, Exhibit 5: pg. no.36-40), Gadanigrahah by Sodhala(Ayurveda, Exhibit 6: pg. no.41-45), Yogaratnakarah(Ayurveda, Exhibit 7: pg. no.46-50), Chimittu Rathna Churukkam by I.N.A(Siddha, Exhibit 8: pg. no.51-58), Rasatantrasarah Evam Siddhaprayogasamgrahah(Ayurveda, Exhibit 9: pg. no.59-63), Sahastrayoga by Govt of India(Ayurveda, Exhibit 10- pg. no.64-6.7), Anuboga Vaithya Navaneetham, Part - 8 by Abdulla Sahib(Siddha, Exhibit 11: pg. no.68-72), Agathiyar Vaithya Kaviyam - 1500 by Agasthiyar(Siddha, Exhibit. 12: pg. no.73-76), Gadanigrahah by Sodhala(Ayurveda, Exhibit 13: pg. no.77-80), Chikithsa Rathna Deepam by Kannusamy Pillai(Siddha, Exhibit 14: pg. no.81-84), Bhaisajya Ratnavali by Govinda Dasa(Ayurveda, Exhibit 15: pg. no:85-90) and Miftaah- al-Khazaain by Kareem Bakhsh(Unani, Exhibit 16: pg. no.91-93). In addition to the -aforesaid references, some other references also exist in TKDL, wherein the above mentioned plants have been used alone or along with few other ingredients for the treatment of Immuno suppressive / Emaciating disease, Rheumatism, Cancer/ Carcinoma, Tuberculosis/Pthysis, Influenza,- Acute diarrhoea,. Cirrhosis of liver, Dysenteric diarrhoea/Haemorrhagic diarrhoea, Cancer/ Carcinoma of Penis and Vagina and as Immuno potentiators/Anti ageing/Anti oxidant and Immuno-potentiator / Immuno-modulator through oral administration. (For details refer exhibits filed with pregrant opposition)”

Full examination report can be referred at 1047-MUM-2008

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 Antala, Jethabhai Ravjibhai/ INDIA.