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), Brassica rapa (Mustard), Plumbago Zeylanaca (chitraka), Psoralea Corylifolia (psoralea), Terminalia Chebula (haritaki) & Embelia Ribes (vidanga) for the treatment of Urticaria / Allergic rashes, Scabies, Itching, Dry & weeping eczema and Psoriasis from the books – Rasatantrasarah Evam Siddhaprayogasamgrahah;- part I (Ayurveda, Exhibit 1 & 3), Balavakadam by Agasthiyar (Siddha, Exhibit 2), Athmarakshaamirtham by Kandasamy Mudaliar (Siddha, Exhibit 4), Rasaratnakarah by Nityanathasiddhah (Ayurveda, Exhibit 5 & 11), Bharata Bhaisajya Ratnakara - Vol.-I (Ayurveda, Exhibit 6), Rasaratnasamuccayah by Vagbhattah (Ayurveda, Exhibit 7), Gadanigrahah ed by Sodhala (Ayurveda, Exhibit 8 & 10) and Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 9).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 1 & 4 are reproduced below.

“Objections:
1065/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 :

D1:AT/237 Pa?canimbac?r?a
Useful in the Treatment of following Diseases : All types(sarvaprak?rake),Leprosy and other dermatoses(ku??ha),
IPC Codes : A61K 125/00, A61K 129/00, A61K 131/00, A61K 31/70, A61K 33/00, A61K 35/20, A61K
Knowledge Known Since : 500 years
Bibliography : Rasayoga S?gara ,??r?gadhara Sa?hit? ,
Keyword(s)/Ingredient(s) : Azadirachta indica A. Juss.(nimba) Leaf(patra),Azadirachta indica A. Juss.(nimba) Root(m?la),Azadirachta indica A. Juss.(nimba) Stem bark(k?n?atvak),Azadirachta indica A. Juss.(nimba) Fruit(phala),Iron(lauha) Calcined / Incinerated drug(Bhasma),Terminalia chebula Retz.(har?tak?) Fruit(phala),Cassia tora Linn.(prapunn??a, cakramarda) Seed(b?ja/ phal?sthi),Plumbago zeylanica Linn.(citraka) Root bark(m?latvak),,Embelia ribes Burm. f. / Embelia tsjeriam-cottam A. Dc Syn. E. robusta C.B Clarke(vi?a?ga) Fruit(phala),Granular sugar(?arkar?) ,Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?) Fruit(phala),Curcuma longa(haridr?) Rhizome(prakanda),Piper longum Linn.(pippal?) Fruit(phala),Piper nigrum Linn.(marica) Fruit(phala),Zingiber officinale Roscoe(?rdraka, ?u??h?) Rhizome(prakanda),Psoralea corylifolia Linn.(b?kuc?) Seed(b?ja/ phal?sthi),Cassia fistula Linn.(?ragvadha) Fruit pulp(phalamajj?),Tribulus terrestris Linn.(gok?ura) Fruit(phala
D2:AB/1065 Khadir?digu?ik? (06) (see annexure D2 )
Useful in the Treatment of following Diseases : Leprosy and other dermatoses(ku??ha),
Knowledge Known Since : 500 years
Bibliography : Bh?rata Bhai?ajya Ratn?kara ,Gadanigraha?,
Keyword(s)/Ingredient(s): triphal?,Terminalia chebula Retz.(har?tak?),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?),Acacia catechu (Linn. f.) Willd.(khadira) Heart wood(k???hamajj?),Pterocarpus marsupium Roxb.(b?jaka (asana)) Heart wood(k???hamajj?),Azadirachta indica A. Juss.(nimba) Stem bark(k?n?atvak),Holarrhena antidysenterica (Roxb. ex Flem.) Wall. ex DC.(ku?aja, indrayava) Stem bark(k?n?atvak),Urine(m?tra) Cow(gau),Water(jala/udaka) ,Semecarpus anacardium Linn.f.(bhall?taka) Fruit(phala),Embelia ribes Burm. f. / Embelia tsjeriam-cottam A. Dc Syn. E. robusta C.B Clarke(vi?a?ga) Fruit(phala),Acorus calamus Linn.(vac?) Rhizome(prakanda),Plumbago zeylanica Linn.(citraka) Root(m?la),Psoralea corylifolia Linn.(b?kuc?) Seed(b?ja/ phal?sthi),Solanum nigram Linn.(k?kam?c?) Root(m?la),

D3:AB/741 K?ka?aghnava?? ( see annexure D3)
Useful in the Treatment of following Diseases : Leprosy and other dermatoses(ku??ha),
Knowledge Known Since : 200 years
Bibliography : Bh?rata Bhai?ajya Ratn?kara ,
Keyword(s)/Ingredient(s): triphal?,Terminalia chebula Retz.(har?tak?),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?),Iron(lauha) Calcined / Incinerated drug(Bhasma),Aconitum ferox Wall. ex Ser. (vatsan?bha bheda) Root tuber(m?lakanda),Plumbago zeylanica Linn.(citraka) Root(m?la),Picrorhiza kurroa(ka?uk?, ku?ak?) Root(m?la),Plumbago zeylanica Linn.(citraka) Root(m?la),Cyperus rotundus Linn. / Cyperus scariosus R. Br. / Cyperus arundinaceum Baker(mustaka, ga??ad?rv?) Rhizome(prakanda),Embelia ribes Burm. f. / Embelia tsjeriam-cottam A. Dc Syn. E. robusta C.B Clarke(vi?a?ga) Fruit(phala),Terminalia chebula Retz.(har?tak?) Fruit(phala),Azadirachta indica A. Juss.(nimba) Stem bark(k?n?atvak),Embelia ribes Burm. f. / Embelia tsjeriam-cottam A. Dc Syn. E. robusta C.B Clarke(vi?a?ga) Fruit(phala),Acacia catechu (Linn. f.) Willd.(khadira) Stem bark(k?n?atvak),Justicia adhatoda Linn. Syn.: Adhatoda vasica Nees(v?s?) Leaf(patra),Tinospora cordifolia Miers(gu??c?) Stem(k???a),

D4:AK10/615 Kustaghna Mahakasaya (see annexure D4)
Useful in the Treatment of following Diseases : Leprosy and other dermatoses(ku??ha),

D5:AK11/2537 Manjisthadi Mahakasaya (see enexure D5)
Useful in the Treatment of following Diseases : Diseases due to vitiated blood(Raktaja roga / Rakta vikara),Itching(ka???),Eruptions(vispho?aka),Intestinal obstruction due to indigestion(alasaka),Psoriasis(ki?ibha),Leucoderma/Vitiligo(??vitra),Eczema (p?m?),

D6:VS/862 Rasendrama?galarasa? (see annexure D6)
Useful in the Treatment of following Diseases : Lepromatous leprosy(pu??ar?kaku??ha),All types(sarvaprak?rake),Leprosy and other dermatoses(ku??ha),

D7:AK/2991 Mah?t??akatailam (cakradatta?)
Useful in the Treatment of following Diseases : All types(sarvaprak?rake),Diseases of skin (carmaroga),
IPC Codes : A61K 125/00, A61K 129/00, A61K 131/00, A61K 133/00, A61K 135/00, A61K 31/00, A61K Knowledge Known Since : 500 years
Bibliography : Cakradatta? ,Bhai?ajya Ratn?val? ,
Keyword(s)/Ingredient(s) : triphal?,Terminalia chebula Retz.(har?tak?),Terminalia bellirica (Gaertn.) Roxb.(bibh?taka),Phyllanthus emblica Linn. Syn.: Emblica officinalis Gaertn.(?malak?) Plumbago zeylanica Linn.(citraka),Alstonia scholaris (Linn.)R. Br.(saptapar?a),Stem bark(k?n?atvak),Azadirachta indica A. Juss.(nimba), Psoralea corylifolia Linn.(b?kuc?) and other ingredients.

Ther a lot of references in the TKDL which indicates the use of Azadirachta Indica (Neem) Oil, Mustard Oil, Plumbago Rosea / Plumbago Zeylanaca, Psoralea Corylifolia, Terminalia Chebula and Embelia Ribes alone or in composition form in the treatment of various types of skin diseases such as fungal skin infection, bacterial skin infections, virus skin infections like eczema, psoriasis, scabies, allergies etc. In view of known uses of the plants it is obvious for a person skilled in the art to combine them in the given ratios and claim for the known uses. In view of above discussed prior art and the prior art cited in the pre grant opposition claims 1-4 of the present application lacks inventive step. Claims should clearly provide the novel and inventive features over the above discussed prior art.

Claims 1-4 falls under section 3(p) of the Patents Act, 1970 as medicinal property of all the plants 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 1065-DEL-2009.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 MAROZHUKAYIL JOSEPH JOSE/ INDIA.