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 Curcuma longa (turmeric), Berberis aristata, Tinospora cordifolia (guduchi), Andrographis paniculata (Bhunimba), Azadirachta indica (neem), Gymnema sylvestre (gudmar), Momordica charantia (karela), Terminalia chebula (haritaki), Terminalia bellirica, Emblica officinalis (aamla), Vetiveria Zizanioides, Withania somnifera (ashwagandha), Strychnos Potatorum, Zingiber officinale (adrak), Piper longum (pippali), Ocimum sanctum (tulasi) and Bacopa monnieri (brahmi) for the treatment of Diabetes mellitus, Diabetic furuncle, Obesity and diseases of heart from the books – Khazaain-al-Advia, Vol III by Mohammad Najmul Ghani Khan (Unani,Exhibit 1), TherayarKappiyam by Therayar (Siddha,Exhibit 2), Agathiar vaithiam by Agasthiyar (Siddha,Exhibit 3), Ayurveda Sarasamgrahah (Ayurveda,Exhibit 4, 5 & 15), Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda,Exhibit 6 & 14), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani,Exhibit 7), Athmarakshaamirtham by Kandasamy Mudaliar (Siddha,Exhibit 8 & 10), Bharata Bhaisajya Ratnakara (Ayurveda,Exhibit 9 & 11), Rasendracintamanaih by Dundukanatha (Ayurveda,Exhibit 12), Vangasena by Vangasena (Ayurveda,Exhibit 13) and Gadanigrahah by Sodhala (Ayurveda,Exhibit 16 ).

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 claimed invention lacks novelty and inventive step u/s 2(1(j)) of the Patents Act, 1970 in view of below cited documents from TKDL and documents cited in the pre grant opposition filed by TKDL(copy attached):
AK15/200A Madhumeha Vinasini Vatika (svarna Yukta)
Useful in the Treatment of following Diseases : Diabetes mellitus(madhumeha),
IPC Codes : A61K 33/00, A61K 35/04, A61K 36/00, A61K 36/27, A61K 36/47, A61K 36/58, A61K 36/9066, A61K 9/08, A61K 9/14, A61K 9/20, A61P 3/10, A61P 5/00, A61P 5/48, C01B 5/00, C01G 19/00, C01G 21/00, C01G 7/00, C01G 9/00
Knowledge Known Since : 50 years
Bibliography : Ras?m?tam ,
Keyword(s)/Ingredient(s) : Lead(n?ga) ,Tin / Stannum(va?ga) ,Zinc(ya?ada) ,Gymnema sylvestre (Retz.) R.Br. ex Schult.(me?a???g?, madhun??in?) Leaf(patra),Azadirachta indica A. Juss.(nimba) Leaf(patra),A gummy exudate collected from rocks(?il?j?ta/?il?jatu) ,Gold(svar?a)

D2:RS21/442 Sresthadi Vati
Useful in the Treatment of following Diseases : Pittaja(pittaja),Kaphaja(kaphaja),Urinary disorders / Polyuria(Prameha / meha),Diabetes mellitus(madhumeha),Diabetic furuncle(prameha pi?ik?),
IPC Codes : A61K 125/00, A61K 129/00, A61K 131/00, A61K 33/00, A61K 36/00, A61K 36/27, A61K 36/328, A61K 36/47, A61K 36/54, A61K 36/58, A61K 36/60, A61K 36/9066, A61K 9/08, A61K 9/20, A61P 13/00, A61P 13/02, A61P 17/02, A61P 29/00, A61P 3/10, A61P 31/00, A61P 31/02, A61P 5/00, A61P 5/48, A61P 5/50, A61P 7/12, C01B 17/00, C01G 19/00
Knowledge Known Since : 50 years
Bibliography : Rasatantras?ra? Evam Siddhaprayogasa?graha?;,
Keyword(s)/Ingredient(s) : triphal?,Terminalia chebula Retz.(har?tak?),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?),Sulphur(Gandhaka) Purified (?uddha),Curcuma longa(haridr?) Rhizome(prakanda),Gymnema sylvestre (Retz.) R.Br. ex Schult.(me?a???g?, madhun??in?) Leaf(patra),Cinnamomum camphora (Linn.) J. Presl(karp?ra) ,Tin / Stannum(va?ga) Calcined / Incinerated drug(Bhasma),Azadirachta indica A. Juss.(nimba) Stem bark(k?n?atvak),Commiphora wightii Bhandari Syn.: C. mukul ( Hook. ex Stocks) Engl.(guggulu) Exudate(niry?sa),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?) Fruit(phala),Gymnema sylvestre (Retz.) R.Br. ex Schult.(me?a???g?, madhun??in?) Leaf(patra),Ficus racemosa Linn.(udumbara) Stem bark(k?n?atvak),Gymnema sylvestre (Retz.) R.Br. ex Schult.(me?a???g?, madhun??in?) Leaf(patra

D3:RG12/814B Candraprabha Vati Anupana Evam Upayoga
Useful in the Treatment of following Diseases : Urinary disorders / Polyuria(Prameha / meha),Polyuria / Diabetes insipidus (udakameha),Diabetes mellitus(madhumeha),Oedema / Inflammation(?otha),
IPC Codes : A61K 131/00, A61K 135/00, A61K 35/20, A61K 36/00, A61K 36/185, A61K 36/29, A61K 36/59, A61K 36/75, A61K 9/08, A61K 9/20, A61P 1/10, A61P 13/00, A61P 13/02, A61P 13/04, A61P Knowledge Known Since : 50 years
Bibliography : ?yurveda S?rasa?graha? ,
Keyword(s)/Ingredient(s) : Freshly milked milk(Dharosna dugdha) ,Tinospora cordifolia Miers(gu??c?) Stem(k???a),Berberis aristata DC. / Berberis asiatica Roxb. / Berberis lycium Royle(d?ruharidr?) Stem(k???a),Aegle marmelos Correa ex Roxb.(bilva) Leaf(patra),Tribulus terrestris Linn.(gok?ura) Fruit(phala),Honey(madhu/k?audra) ,

D4:SL1/413 Madhumehari Yoga
Useful in the Treatment of following Diseases : Burning sensation in palms and soles(hasta pada daha),Pyrexia(jvara),Polyuria / Diabetes insipidus(udakameha),Urinary disorders / Polyuria(Prameha / meha),Dryness of mouth(mukha?o?a),Polydipsia / Excessive thirst(t????),Diabetes mellitus(madhumeha),
IPC Codes : A61K 125/00, A61K 131/00, A61K 135/00, A61K 35/04, A61K 36/00, A61K 36/185, A61K 36/27, A61K 36/42, A61K 36/48, Knowledge Known Since : 0 years
Bibliography : Siddaprayogalatika
Keyword(s)/Ingredient(s) : Momordica charantia Linn.(k?ravellik?) Fruit(phala),Pterocarpus marsupium Roxb.(b?jaka (asana)) Heart wood(k???hamajj?),Syzygium cuminii (Linn.)Skeels(jamb?) Seed(b?ja/ phal?sthi),Azadirachta indica A. Juss.(Nimba) Leaf(patra),Swertia chirayita (Roxb. ex Flem.) Karst.(kir?tatikta) St.Bark,Leaf,Flower,Fruit&Root(Pancanga),Picrorhiza kurroa(ka?uk?, ku?ak?) Rhizome(prakanda),Calotropis gigantea (Linn.) Ait. f.(alarka (?veta)) Root(m?la),Salacia chinensis Linn. Syn. S.latifolia Wall. ex M. Laws.,S.prinoides DC (saptara?g?, saptacakr?) ,Trigonella foenum-graecum Linn.(meth?) Seed(b?ja/ phal?sthi),Cinnamomum tamala Nees(tejapatra, nalik? (sth?n?panna au?adhi)) Leaf(patra),A gummy exudate collected from rocks(?il?j?ta/?il?jatu) Purified(?uddha),Curcuma longa(haridr?) Rhizome(prakanda),Gymnema sylvestre (Retz.) R.Br. ex Schult.(me?a???g?, madhun??in?) Leaf(patra),Sesamum indicum Linn.(tila) Seed(b?ja/ phal?sthi),Papaver somniferum Linn.(ahiphena) Fruit exudate(phalaniry?sa),cow urine(gaumutra) ,Azadirachta indica A. Juss.(Nimba) Leaf(patra),

D5:GP04/82 Kodaga Sala Kuligai
Useful in the Treatment of following Diseases : Vataja(Vali,Vaatham,Vaayu),Cancer/ Carcinoma(Putru noi, Vipuruthi),Ascites(Peruvayiru),Ozaena, sinusitis(HR)(Neer Kovai),Retention of urine(Neer kattu),Syncope/Fainting(Mayakka noi,Sanniyaasam),Pain(Vali),Incurable(Theeraa Noigal),Ulcer / Wound Healing(Pun),Ascites(Peruvayiru),Diabetes mellitus(Inippuneer/Neerazhivu),Disease(Noi,Viyaadhi,Pini),Ulcer / Wound Healing(Pun),Acne vulgaris(Muga paru),Pain(Vali),Diseases of the eye(Kan Noigal),
IPC Codes : A61K 131/00, A61K 35/20, A61K 35/22, A61K 35/24, A61K 35/413, A61K 36/00, A61K 36/185, A61K 36/19, A61K 36/42, A61K 36/47, A61K 36/53, A61K 36/67, A61K 36/725, A61K 36/75, Knowledge Known Since : 500 years
Bibliography : Therayar Maha Karisal,
Keyword(s)/Ingredient(s) : Bovine gall stone / Bezoar(Gorojanam,Myrosanam,Vathsala mani,Rosanam,Komandhiram) ,Zingiber officinale Roscoe(Inji, chukku) Rhizome(Ver Kombu,Matta nila thandu),Piper nigrum Linn.(Milagu) Fruit(Pazham),Piper longum Linn.(Thippili, Pippili) Fruit(Pazham),Terminalia chebula Retz.(Kadukkaai) Unripe fruit(Pazhakkaai),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(Nelli) Unripe fruit(Pazhakkaai),Terminalia bellirica (Gaertn.) Roxb.(Thaandri) Unripe fruit(Pazhakkaai),Costus speciosus (Koen. ex Retz.) Smith(Koshtam, Kura, Oli, Kuravam) Rhizome(Ver Kombu,Matta nila thandu),Orpiment / Arsenic trisulphide(Thalakam,ArIthaaram,Ponvarni,Maaldevi,Kothandham,Peethagi,Aalambi,Kaal puthi,Paluppu,Manjal varni) ,Coral / Corallium rubrum(Pavazham,Pravaalam,Thukir,Thuppu,Vaarithi thandu,Senthandu maalai) ,Coccinia grandis (Linn.) Voigt Syn.: C. indica Wight & Arn. (Kovai, Kuwai) Root(Ver),Molineria finalysoniana Bak.(Nilapanai) Root(Ver),Zizyphus mauritiana Lam.(Ilandhai, Aditharam, Iradi, Koli, Kullari, Sivagam, Veyam, Padari) Root(Ver),Leucas aspera Spreng.(Thumbai,Imuganaar vettri) Root(Ver), Root(Ver),Cannabis sativa Linn.(Kanja,Korakkar mooli,Siva mooli,Karpa mooli,Moodandam,Bangi,Madhamathakam) Root(Ver),Cow(Pasu,Komaadhaa) ,Hopea glabra Wight& Arn.(Kongu) Leaf(Ilai,Thazhai),Indoneesiella echiodes (Linn.) Sreen. Syn. Andrographis echioides (Linn.)

D6:AK/2328 Triphal?dyamlauham
Useful in the Treatment of following Diseases : Obesity (medov?ddhi),Lethargy(a?gas?da),Itching(ka???),Disease with Kapha predominance(kaphavik?ra),
IPC Codes : A61K 125/00, A61K 129/00, A61K 131/00, A61K 135/00, A61K 31/00, A61K 36/00, A61K Knowledge Known Since : 200 years
Bibliography : Bh?rata Bhai?ajya Ratn?kara ,Cakradatta? ,Gadanigraha? ,Bhai?ajya Ratn?val? ,V?ndam?dhava,
Keyword(s)/Ingredient(s) : triphal?,Terminalia chebula Retz.(har?tak?),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?),Sesamum indicum Linn.(tila) Oil(taila),Ammi visnaga (Linn.) Lam. (p????abhed?) Rhizome(prakanda),Marsdenia tenacissima Wight. & Arn. / Chonemorpha fragrans (Moon) Alston Syn. C. macrophylla (Roxb.) G. Don. (m?rv?) Root(m?la), Root(m?la),Plumbago zeylanica Linn.(citraka) Root(m?la),Justicia adhatoda Linn. Syn.: Adhatoda vasica Nees(v?s?) Leaf(patra),Azadirachta indica A. Juss.(nimba) Stem bark(k?n?atvak),Cassia fistula Linn.(?ragvadha) Fruit(phala),Acorus calamus Linn.(vac?) Root(m?la),Alstonia scholaris (Linn.)R. Br.(saptapar?a) Stem bark(k?n?atvak),Curcuma longa(haridr?) Rhizome(prakanda),Berberis aristata DC. / Berberis asiatica Roxb. / Berberis lycium Royle(d?ruharidr?) Root(m?la),Tinospora cordifolia Miers(gu??c?) Stem(k???a),Vitex negundo Linn.(nirgu???, re?uk? bheda) Leaf(patra), Fruit(phala),Saussurea lappa Clarke(ku??ha) Root(m?la),Brassica rapa Linn. Syn.: B. campestris Linn.(sar?apa) Seed(b?ja/ phal?sthi),Zingiber officinale Roscoe(?rdraka, ?u??h?) Rhizome(prakanda),Water(jala/udaka).

D7:PD04/54 Amukkara Karpam
Useful in the Treatment of following Diseases : Obesity (Udal Paruman,Athi thoola noi),Anaemia / Hyperbilirubinaemia (Velluppunoi,Paandu,Ratha kuraivu),Rat bite poisoning(Elikkadi Nanju),Snake bite(Paampukkadi),Scabies, Itch(Sori sirangu),Emaciation /Cachexia(Udal Ilaippu Noi),Pain(Vali),Gastric ulcer/Acute gastritis(Gunmam/Iraippai Soolai , Aamasoolai),Hyperemesis gravidarum(Sool Vaanthi,Masakkai,Sool vida vaanthi),Leprosy(Thozhunoi, Kuttam, Perunoi),Vataja(Vali,Vaatham,Vaayu),Disease(Noi,Viyaadhi,Pini),Gaseous/Flatulence(Vaayu),Amenorrhoea(Soothaga Thadai),Delirium(Sanni Noi),Carbuncle/Furuncle(Pilavai, Vipuruthi, Pudai),Oedema / Inflammation(Veekkam),Diseases of Infants and Children (Kuzhavi/ Kuzhanthai Noigal),Whooping cough(Kakkuvaan Erumal),Jaundice(Manjal noi ,kamalai,Pithu noi),
IPC Codes : A23C 15/00, A61K 129/00, A61K 131/00, A61K 35/20, A61K 35/22, A61K 36/00, A61K Knowledge Known Since : 1000 years
Bibliography : Agathiar vaithiam 600,
Keyword(s)/Ingredient(s) : Withania somnifera (Linn.) Dun.(Nattuamukira Irulichevi, Kidichevi, nagudaver, Varagakarni, Asubam, Amukkra) St.Bark,Leaf,Flower,Fruit&Root(Samoolam)

The said ingredients are already known traditionally for their use in treatment od diabetic complications either alone or in combination.There are lot of documents in TKDL related to the use of ingredients claimed in the composition for the diabetes treatment.Thus in view of known use of these ingredients either alone or in combination foprm claims 1-8 of the present application lacks novelty and inventive step.
Claims 1-8 falls under section 3(p) of the Patents Act, 1970 as medicinal property of all the extracts and the minerals given the composition claim are known in traditional knowledge.The invention as claimed is traditional knowledge and aggregation or duplication of known properties of traditionally known components.”

Full examination report can be referred at 2645-Del-2005.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 SHUBHASH CHANDER SEHGAL/ INDIA.