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 Alpinia galanga, Piper longum (pippali), Vitis vinifera (grape), Piper nigrum (Black Pepper) ,Curcuma longa (turmeric), Cinnamomum zeylanicum (cinnamon), Elettaria cardamomum (elaichi), Curcuma zedoaria (zedoary), Kaempferia galanga and Jaggery (Gurh) for the treatment of Cough/Bronchitis, Bronchial asthma and a type of inflammation in the throat from the books – Kasyapa Samhita or Vrddhajivakiya Tantra by Vrddhajivaka (Ayurveda, Exhibit 1), Bharata Bhaisajya Ratnakara - Compiled by Naginadasa Chaganalala Saha (Ayurveda, Exhibit 2), Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 3), Rasaratnakarah-Rasendra by Nityanathasiddhah (Ayurveda, Exhibit 4), Caraka Samhita by Agnivesa (Ayurveda, Exhibit 5 & 7), Chikithsa Rathna Deepam by Kannusamy Pillai (Siddha, Exhibit 6), Astanga Hrdaya by Vagabhata (Ayurveda, Exhibit 8), Basavarajiyam by Basavaraja (Ayurveda, Exhibit 9) and Therayar Karisal by Therayar (Siddha, Exhibit 10).

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:
Subject matter of the claimed invention lacks 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 filed by TKDL :

(Source :TKDL)D1:AB/888 Kum?ry?sava? (01) (pl see annexure D1)
D1:It discloses the use of these ingredients along with other ingredients in the treatment of cough/bronchitis: Cinnamomum zeylanicum Blume(tvak),Elettaria cardamomum (Linn.), Piper longum Linn.(pippal?, Piper nigrum Linn.(marica), Alpinia galanga(Linn.), Vitis vinifera Linn.(dr?k??),Honey(madhu/k?audra),Jaggery & its preparations(gu?a), Curcuma longa(haridr?) .Above ngrdients are also claimed in the claim-1 of the present application.

D2:AJ/684 Draksa Avaleha (annexure D2)
Useful in the Treatment of following Diseases : Cough / Bronchitis(k?sa),
Ingredients used:Cinnamomum zeylanicum Blume(tvak),Elettaria cardamomum (Linn.) Maton(s?k?mail?),Cinnamomum tamala Nees(tejapatra, Vitis vinifera Linn.(dr?k??), Curcuma longa, Piper longum , Alpinia galangal along with some other ingredients.

D3:AK2/591 Haritakyasava : (annexure D3)
Useful in the Treatment of following Diseases Cough / Bronchitis(k?sa
Ingredients used :Vitis vinifera Linn.(dr?k??) Fruit(phala),,Jaggery & its preparations(gu?a) ,Honey(madhu/k?audra) ,Piper longum Linn.(pippal?) Fruit(phala),Cinnamomum zeylanicum Blume(tvak) Stem bark(k?n?atvak),Elettaria cardamomum (Linn.) ),Cinnamomum tamala Nees(tejapatra, nalik? (sth?n?panna au?adhi)) Leaf(patra) , Alpinia galanga(Linn.along with some other ingredients.

D4:AM05/2074 Vilvaadhi Ilagam-3 (plsee annexure D4)
Useful in the Treatment of following Diseases : Cough / Bronchitis(Irumal,Kaasam),Cough / Bronchitis(Irumal,Kaasam),Cough / Bronchitis(Irumal,Kaasam),Burning sensation(Erivu), (Velluppunoi,Paandu,Ratha kuraivu),Pyrexia(Suram),Distension of abdomen(Vayiru
IPC Codes : A61K 131/00, A61K 133/00, A61K 135/00, A61K 35/20, A61K 36/185, A61K 36/23, A61K
Knowledge Known Since : 1000 years
Bibliography : Athmarakshaamirtham,
Keyword(s)/Ingredient(s): ,Zingiber officinale Roscoe(Inji, chukku) Rhizome(Ver Kombu,Matta nila thandu),Piper cubeba Linn. f.(Vaalmilaku, Thakkoolam, Ilathai, Thoorikai) Fruit(Pazham),Cinnamomum wightii Meissn.(Sirunagappu) Flower Bud(Poo Mokku),Piper longum Linn.(Thippili, Pippili) Fruit(Pazham),Alpinia officinarum Hance(chitrarathai, Channarashttam, Irattai) Rhizome(Ver Kombu,Matta nila thandu),Piper nigrum Linn.(Milagu) Root(Ver),Cuminum cyminum Linn.(Seerakam, Asai, Seeri, Posanakudori,Upakumba peesam,Pittha naasini,Prathivikaa,Methiyam) ,Strychnos potatorum Linn. f. (Thetraan kottai, Illam, Akkolam, Sillam, Teru, Kadali) Root(Ver),Plumbago zeylanica Linn.(Chithiramoolam, Venkodi veli, Sittragam) Root(Ver),Elettaria cardamomum (Linn.) Maton(Yaelakkai,Aanji,Dhudi,Korangam) ,Syzygium aromaticum (Linn.) Merr. & L.M. Perry(Kiraambu,Lavangam,Anjugam,Urkadam,Thirali,Varaangam,Karuvai, Karuvapoo) Flower Bud(Poo Mokku),Pogostemon plectranthoides Desf.(Pachilai) Leaf(Ilai,Thazhai),Kaempferia galanga Linn.(Kacholam, Kacholakizhangu) Tuber/bulb/corm(Kizhangu),Cow(Pasu,Komaadhaa) Clarified butter(Nei),
It discloses the role of piper, Cinnamomum ,Syzygium aromaticum(synonym of Eugenia caryophyllata ), Elettaria ,Alpinia and kaempferia in the treatment of respiratory disorders as also claimed in present application.

D5:BS05/181(see annexure D5):
Useful in the Treatment of following Diseases :Cough / Bronchitis(Irumal,Kaasam),Burning sensation(Erichal),Venereal disease(Maega noi, Vettai noi),Hypertrophic or chronic rhinitis/frontal sinusitis(Mandaikutthu),
Ingredients disclosed are Cinnamomum , Kaempferia galanga Linn.(Kacholam, Kacholakizhangu) , Alpinia , Elettaria cardamomum (Linn.) along with other ingredients.

D6:RS8/614 Mahajambu Gu??
Useful in the Treatment of following Diseases : Disease with Kapha predominance(kaphavik?ra),Cough / Bronchitis(k?sa),
IPC Codes : A61K 131/00, A61K 36/61, A61P 1/12, A61P 1/14, A61P 11/00, A61P 11/06, A61P 11/08, A61P 11/12, A61P 19/00, A61P 21/00, A61P 21/06, A61P 29/00, A61P 3/02, A61P 31/00, A61P 37/08, A61P 7/10
Knowledge Known Since: 200 years
Bibliography : R?janigha??au? ,
Keyword(s)/Ingredient(s) : Syzygium formosum (Wall.) Masam. Syn.: Eugenia formosa Wall.(jambubheda) Fruit(phala),

Claim-1 of the present application is related to a composition useful for treatment in chronic respiratory disorders such as cold cough, allergic, asthma, whooping cough, throat infection comprising;Piper Nigrum, Piper Longum, Elettaria Cardamomum, Potassium Carbonate, (Chavarkaram), Manayola, Gurh, Cinnamomum Zeylanicum, Vitis Vinifera, Alpinia Galanga / Alpinia Calcarata, Eugenia Caryophyllaea, Kaemferia Galanga / Curcuma Zedoaria Rose, Curcuma Longa.
Above cited documents also discloses the use of these said ingredients in different combinations for the treatment of respiratory disorders.There are lot of documents in the TKDL which discloses the use of these ingredients in combination form for the treatment of respiratory disorders as mentioned in the claim. Thus based on the prior art the combination of these plants would be obvious for the treatment of respiratory disorders. The combination of a plant with a known therapeutic effect with further plants with the same known therapeutic effect, wherein all plants are previously known for treating the same disease is considered to be an obvious combination.
Subject matter of the claims 1-4 which are related to composition and process of making composition by mixing these ingredients lacks inventive step in view of above discussed prior art.

Claims falls under section 3(p) of the Patents Act, 1970 as medicinal property of all the extracts and the plants 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 1066-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.