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 Azadirachta indica (neem), Symplocos racemosa (lodhra), Rubia cordifolia (indian madder), Glycyrrhiza glabra (licorice), Prunus cerasoides (birdcherry), Saussurea lappa (saw-wort), Curcuma longa (turmeric), Berberis aristata (daruharidra), Jasminum officinale (jasmine), Hemidesmus indicus (sariva), Pongamia pinnata (karanj), Terminalia chebula haritaki), Piper nigrum (Black Pepper), Picrorhiza kurroa (kutaki), Celastrus paniculatus (staff tree), Brassica rapa (mustard), Olea europaea(olive) and Sesamum indicum (sesame) for the treatment of Freckle, Chloasma / Melasma / Melanoderma, Non elevated mole, Elevated mole, Capillary angiomata, naevi, Acne vulgaris, Papilloma of the skin, Congenital mole, Leprosy and other dermatoses, Diseases of skin, Eczema, Psoriasis, Pityriasis, Seborrhoea,Pityriasis capitis / Furunculosis or boils in scalp, Dry & weeping eczema, Non-lepromatous leprosy, Ring worm, Itching,Wet Scabies, Non-unctuous / Dry / Rough Skin/Hide, Boil, Alopecia, Septic wounds, Ptyriasis Alba, Leucoderma/Vitiligo,all types of Pustules and as Beneficial for hair from the books – Bharata Bhaisajya Ratnakara (Ayurveda,Exhibit 1 & 2), Rasendramangalama by Nagarjuna (Ayurveda, Exhibit 3), Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 4), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani,Exhibit 5 & 18), Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 6), Agnipuranama (Ayurveda, Exhibit 7), Qaraabaadeen Qaadri by Mohammad Akbar Arzani (Unani,Exhibit 8), Sodhalanighantauh by Sodhala (Ayurveda, Exhibit 9), Muheet Azam, Vol. IV by Mohammad Azam Khan (Unani, Exhibit 10), Brhat Nighantau Ratnakara (Saligramanighantubhusanam) (Ayurveda, Exhibit 11), Rasaratnasamuccayah by Vagbhattah (Ayurveda, Exhibit 12), Muheet-e-Azam, Vol. I by Mohammad Azam Khan (Unani,Exhibit 13 & 17), Muheet-e-Azam Vol. III by Mohammad Azam Khan (Unani, Exhibit 14), Khazaain-al-Advia, Vol II by Mohammad Najmul Ghani Khan (Unani, Exhibit 15) and Vangasena by Vangasena (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, 3 & 4 are reproduced below.

“Objections:

1212/del/2009
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 and documents cited in the pre grant opposition (attached along with):
(Source TKDL)D1:RG9/298 Katuka Guna (see annexure)
Useful in the Treatment of following Diseases : Ring worm (dadru),Diseases of skin (carmaroga),Diseases of heart(h?dayaroga),Diseases of spleen(pl?h?vik?ra),Disease(roga/ vy?dhi),
IPC Codes : A61K 125/00, A61K 36/80, A61P 1/04, A61P 1/06, A61P 1/08, A61P 17/00, A61P 17/02, A61P 17/04,
Knowledge Known Since : 500 years
Bibliography : So?halanigha??au? ,
Keyword(s)/Ingredient(s) : Picrorhiza kurroa(ka?uk?, ku?ak?) Rhizome(prakanda),

D2:MH5/3106B Marham Aswad Deegar (see annexure)
Useful in the Treatment of following Diseases : Wound(Zakhm/Jaraahat),Piles / Ano rectal mass / Haemorrhoids(Bawaaseer),Anal Fissure(Shiqaaq -e- Maq"ad),Scabies, Itch(Jarab-wa-Hikka),Alopecia (Daa-al-Sa?lab),Septic wounds(Jurooh-e-Muta?ffinah),
IPC Codes : A61J 3/00, A61J 3/04, A61K 31/04, A61K 31/05, A61K 36/63, A61K 36/9066, A61K 9/08,
Knowledge Known Since : 500 years
Bibliography : Quaraabaadeen Quaadri,
Keyword(s)/Ingredient(s) : Massicot/Lead oxide/Plumbi oxidum(Murdaar Sang) ,Olea europaea Linn.(Zaitoon) Oil(Roghan),Alcoholic drink(Sharaab) ,Curcuma longa(Zard Chob/Haldi/ Urooq al Sufr/ Urooq al Zafraan) ,

D3:NA4/2331 Raughan Daa-al-saalab (see annexure D3)
Useful in the Treatment of following Diseases : Alopecia (Daa-al-Sa?lab),

D4:MA2/222 Nuskha-e-tila
Useful in the Treatment of following Diseases : Alopecia (Daa-al-Sa?lab),Alopecia Furfuracea(Daa-al-Hayyah),
IPC Codes : A61K 125/00, A61K 31/10, A61K 36/00, A61K 36/185, A61K 36/58, A61K 36/76, A61P 17/00, A61P 17/14
Knowledge Known Since : 1000 years
Bibliography : Kitaab al U"mdah fil Jeraahat ,
Keyword(s)/Ingredient(s) : Salix caprea Linn.(Bed Mushk) Leaf(Barg/Patti),Sesamum indicum Linn.(Kunjad Siyah/Til/Sheeraj) Leaf(Barg/Patti),Azadirachta indica A. Juss.(Neem) Leaf(Barg/Patti),Sesamum indicum Linn.(Kunjad Siyah/Til/Sheeraj) Root(Beekh/Asl/Usool),

D5:AK10/639 Brihanamajistadi Kvatha
Useful in the Treatment of following Diseases : Diseases of skin (carmaroga),All types(sarvaprak?rake),Leprosy and other dermatoses(ku??ha),Gout (v?tarakta),Paraesthesia(prasupti),Erysipelas(visarpa),Abscess (vidradhi),Diseases due to vitiated blood(Raktaja roga / Rakta vikara),
IPC Codes : A61K 125/00, A61K 129/00, A61K 131/00, A61K 135/00, A61K 36/00, A61K 36/15, A61K /00
Knowledge Known Since : 200 years
Bibliography : Yogatrangini ,
Keyword(s)/Ingredient(s) : triphal?,Terminalia chebula Retz.(har?tak?),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka),Rubia cordifolia Linn.(ma?ji??h?) Stem(k???a),Curcuma longa(haridr?) Rhizome(prakanda),Berberis aristata DC. / Berberis asiatica Roxb. / Berberis lycium Royle(d?ruharidr?) Stem(k???a),Azadirachta indica A. Juss.(nimba) Fruit(phala),Trichosanthes dioica Roxb.(pa?ola) Leaf(patra),Saussurea lappa Clarke(ku??ha) Root(m?la),Picrorhiza kurroa(ka?uk?, ku?ak?) Rhizome(prakanda),Piper longum Linn.(pippal?) Fruit(phala),Melia azedarach Linn.(mah?nimba, kai?arya) Stem bark(k?n?atvak),Hemidesmus indicus (Linn.) R. Br.(s?riv? (utpalas?riv?)) Root(m?la),Pongamia pinnata (Linn.) Pierre(kara?ja, noda Linn. Syn.: Adhatoda vasica Nees(v?s?) ,Fumaria indica Pugsley Syn.: F.parviflora auct. pl. ,non Lam. (parpa?a bheda (y?.)) St.Bark,Leaf,Flower,Fruit&Root(Pancanga),Cryptolepis buchanani (k???as?riv?, jamb?patr? s?riv?) Stem bark(k?n?atvak),Aconitum heterophyllum Wall. ex Royle(ativi??) Root(m?la),Fagonia cretica Linn. / Alhagi pseudalhagi (Bieb.) Desv.(dhanvay?sa) St.Bark,Leaf,Flower,Fruit&Root(Pancanga),Trichosanthes bracteata (Lam.) Voigt Syn. T.palmata Roxb.(vi??l?, mah?k?la) ,Valeriana jatamansii Jones Syn.: V. wallichii DC.(tagara, b?laka) Root(m?la), along with other ingredients.

D6:AK2/169A Vajrakam Tailam (see annexure)
Useful in the Treatment of following Diseases : Vata-kaphaja(v?takaphaja),Diseases of skin (carmaroga),Sinus / Fistula (n???),
IPC Codes : A61K 125/00, A61K 129/00, A61K 131/00, A61K 135/00, A61K 31/00, A61K 35/22, A61K
Knowledge Known Since : 500 years
Bibliography : Gadanigraha?,

D7:MH3/137H Zimaad -e- Asl -us- Soos
Useful in the Treatment of following Diseases : Alopecia (Daa-al-Sa?lab),Skin Marks(Jild ke daag dhabbe),Septic wounds(Jurooh-e-Muta?ffinah),
IPC Codes : A61K 125/00, A61K 36/484, A61P 17/00, A61P 17/14, A61P 29/00, A61P 31/04, C01B 5/00
Knowledge Known Since : 200 years
Bibliography : Muheet Azam,
Keyword(s)/Ingredient(s) : Glycyrrhiza glabra Linn.(Rubb-al-Soos/Asl-al-Soos) Root(Beekh/Asl/Usool),Water(Aab) ,

D8:AK10/792 Khalitya Cikitsa
Useful in the Treatment of following Diseases : Alopecia (kh?litya),
IPC Codes : A61K 129/00, A61K 131/00, A61K 133/00, A61K 36/00, A61K 36/185, A61K 36/53, A61K 36/62, A61K 36/85, A61K 9/06, A61P 17/00, A61P 17/14
Knowledge Known Since : 200 years
Bibliography : Yogatrangini ,
Keyword(s)/Ingredient(s) : Nymphaea stellata Willd.(utpala (n?la)) Flower(pu?pa),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka) Fruit(phala),Sesamum indicum Linn.(tila) Seed(b?ja/ phal?sthi),Ocimum basilicum Linn.(barbar?) Leaf(patra),Callicarpa macrophylla Vahl(priya?gu) Flower(pu?pa),Madhuca longifolia (Koen.) Macbr. Syn.: M. indica J.F. Gmel.(madh?ka) Stem bark(k?n?atvak),

D9:AT/1021 Vibh?takatailam
Useful in the Treatment of following Diseases : Premature grey hair / Canities(palita),Alopecia (kh?litya),
IPC Codes : A61K 125/00, A61K 129/00, A61K 131/00, A61K 133/00, A61K 135/00, A61K 36/00, A61P 17/14, C01G 21/21, C01G 49/00, C01G 49/14
Knowledge Known Since : 1000 years
Bibliography : Su?ruta Sa?hit? ,
Keyword(s)/Ingredient(s) : triphal?,Terminalia chebula Retz.(har?tak?),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?),Barleria prionitis Linn.(saireyaka (p?ta pu?pa), sahacara) Flower(pu?pa),Syzygium cuminii (Linn.)Skeels(jamb?) Leaf(patra),Terminalia arjuna (Roxb.) Bedd.(arjuna) Stem bark(k?n?atvak),Cassia occidentalis Linn.(k?samarda) St.Bark,Leaf,Flower,Fruit&Root(Pancanga),Sesamum indicum Linn.(tila) Seed(b?ja/ phal?sthi),Eclipta prostrata (Linn.) Linn. Syn.: E. alba (Linn.) Hassk. (bh??gar?ja) Seed(b?ja/ phal?sthi),Mangifera indica Linn.(?mra) Seed(b?ja/ phal?sthi),Boerhaavia verticillata Poir.(punarnav? ?veta) Root(m?la),Nelumbo nucifera Gaertn.(kamala, prapau??ar?ka (sth?n?panna au?adhi)) Root(m?la),Solanum surattense Burm. F. Syn.: S. xanthocarpum Schrad. & Wendl.(ka??ak?r? (?veta praj?ti lak?ma?? sth?n?panna au?adhi)) St.Bark,Leaf,Flower,Fruit&Root(Pancanga),Iron sulphate(k?s?sa) ,Iron(lauha) ,Xeromphis spinosa (Thunb.) Keay Syn.: Randia dumetorum (Retz.) Lam.(madana, mainaphala) Seed(b?ja/ phal?sthi),Galena(a?jana) ,Glycyrrhiza glabra Linn.(ya??imadhu, kl?taka (sth?n?panna au?adhi)) Root(m?la),Nymphaea stellata Willd.(utpala (n?la)) Root(m?la),Hemidesmus indicus (Linn.) R. Br.(s?riv? (utpalas?riv?)) Root(m?la),Jasminum sambac (Linn.) Ait.(mallik?, v?r?ik?, madayant? (sth?n?panna au?adhi)) Leaf(patra),Pterocarpus marsupium Roxb.(b?jaka (asana)) Heart wood(k???hamajj?),

Above cited documents from tkdl also discloses the use of these ingredients either alone or in combination for the treatment of alopecia and other skin disorders.There are lot of refeences in tkdl which shows the combination of these ingredients.Thus in view of known uses of these claimed ingredients a person skilled in the art can easily combine them and claim in composition form for the known traditional uses that is alopecia and skin disorders thus the claims 1-8 of the present invention lacks novelty and inventive step.

Claims fall u/s 3(d) of the Patents (Amended) Act, 2005 as the said claims defines new use and/or new form of the known compounds (as cited by the prior art documents as described in para 1 of the report).

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 1212-DEL-2009.pdf

3. Outcomes of Pre-Grant Opposition & Examination Report.

As the outcome of TKDL references and other documents cited in examination report, the Application is Abandoned U/S 21(1).