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 Acorus calamus (calamus), Alpinia galangal, Psoralea corylifolia (Psoralea), Piper longum (Indian Long Pepper) and Piper nigrum (Black Pepper) for the treatment of Bronchial asthma, Paediatric asthma, Cough / Bronchitis, Phlegmetic Cough, Pneumonia, Dyspnoea and as an Expectorant from the books – Khazaain-al-Advia, Vol. I by Mohammad Najmul Ghani Khan (Unani, Exhibit 1, 2 & 8), Muheet-e-Azam, Vol. I by Mohammad Azam Khan (Unani, Exhibit 3), Therayar Venba by Therayar (Siddha, Exhibit 4), Khazaain-al-Advia, Vol II by Mohammad Najmul Ghani Khan (Unani, Exhibit 5), Khazaain-al-Advia, Vol III by Mohammad Najmul Ghani Khan (Unani, Exhibit 6), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani, Exhibit 7 & 12), Bramamuni karukkadai by Bramamuni (Siddha, Exhibit 9); Kannusamiyam by Kannusamy Pillai (Siddha, Exhibit 10); Rasayoga Sagara (Ayurveda, Exhibit 11) and Ilaaj-al-Amraaz by Mohammad Shareef Khan (Unani, Exhibit 13).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 1 & 3 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:

RD/618 Bhall?tak?valeha? (see annexure 1):it discloses all the 5 ingredients as claimed in claim-1 for the treastment of bronchitis.
AK10/637 Bhall?tak?valeha? (see annexure 2) :it discloses all the 5 ingredients as claimed in claim-1 for the treastment of bronchitis.
K10/637 Bhall?tak?valeha?
Useful in the Treatment of following Diseases : Cough / Bronchitis(k?sa),
IPC Codes : A23, A61K 125/00, A61K 129/00, A61K 131/00, A61K 135/00, A61K 35/78, A61K 36/00, A61K 36/185, A61K 36/19, A61K 36/22, A61K 36/23, A61K 36/24, A61K 36/27, A61K 36/28, A61K
Knowledge Known Since : 200 years
Bibliography : Yogatrangini ,
Keyword(s)/Ingredient(s) : Psorale corylifolia Linn.(b?kuc?),Seed(b?ja/ phal?sthi),Fagonia cretica Linn. / Alhagi pseudalhagi (Bieb.) Desv.(dhanvay?sa),Acorus calamus Linn.(vac?),Acacia catechu (Linn. f.) Willd.(khadira),Stem bark(k?n?atvak),Pterocarpus santalinus Linn. f.(raktacandana),Heart wood(k???hamajj?), panicultata (Burm.) Nees / Swertia chirayita (Roxb. ex Flem.) Karst.(bh? Wight. & Arn. / Chonemorpha fragrans (Moon) Alston Syn. C. macrophylla (Roxb.) G. Don. (m?rv?), Piper longum Linn.(pippal?),Cassia fistula Linn.(?ragvadha),Alstonia scholaris (Linn.)R. Br.(saptapar?a),Abrus precatorius Linn.(gu?j?),Gloriosa superba Linn.(l??gal?),Pluchea lanceolata Oliv. & Hiern / Alpinia galanga(Linn.)Willd.(r?sn?),Pongamia pinnata (Linn.) Pierre(kara?ja, naktam?la,

AB/817 Ka??ak?r?gh?tam (03)
Useful in the Treatment of following Diseases : Paediatric asthma(b?la?v?sa),Paediatric cough(Bala kasa),Pyrexia(jvara),Anorexia (arocaka),Colic (??la),Disease with Kapha predominance(kaphavik?ra),
IPC Codes : A61K 125/00, A61K 131/00, A61K 135/00, A61K 35/20, A61K 36/00, A61K 36/15, A61K Knowledge Known Since : 200 years
Bibliography : Bh?rata Bhai?ajya Ratn?kara ,
Keyword(s)/Ingredient(s) : Scindapsus officinalis Schott(gajapippal?) Fruit(phala),Piper longum Linn.(pippal?) Fruit(phala),Piper nigrum Linn.(marica) Fruit(phala),Glycyrrhiza glabra Linn.(ya??imadhu, kl?taka (sth?n?panna au?adhi)) Root(m?la),Acorus calamus Linn.(vac?) Rhizome(prakanda),Piper longum Linn.(pippal?) Root(m?la),Nardostachys Jatamansi (D.Don) DC.(ja??m??s?, mur? (sth?n?panna au?adhi)) Root(m?la),Piper retrofractum Vahl Syn.: P. chaba Hunter(cavya) Stem(k???a),Plumbago zeylanica Linn.(citraka) Root(m?la),Pterocarpus santalinus Linn. f.(raktacandana) Heart wood(k???hamajj?),Cyperus rotundus Linn. / Cyperus scariosus R. Br. / Cyperus arundinaceum Baker(mustaka, ga??ad?rv?) Stem tuber(k???akanda),Tinospora cordifolia Miers(gu??c?) Stem(k???a),Santalum album Linn.(candana (?veta)) Heart wood(k???hamajj?),Trachyspermum ammi (Linn.) Spragne(yav?n?) Seed(b?ja/ phal?sthi),Cuminum cyminum Linn.(?vetaj?raka) Fruit(phala),Sida cordifolia Linn.(bal?) Root(m?la),Zingiber officinale Roscoe(?rdraka, ?u??h?) Rhizome(prakanda),Vitis vinifera Linn.(dr?k??) Fruit(phala),Punica granatum Linn.(d??ima) Fruit(phala),Cedrus deodara (D.Don) G.Don(devad?ru) Heart wood(k???hamajj?),Clarified butter(gh?ta/sarpi) Cow(gau),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),Solanum indicum Linn.(b?hat? (kerala)) St.Bark,Leaf,Flower,Fruit&Root(Pancanga),Clerodendrum divaricatum Jack Syn.: C. serratum Spreng. / Clerodendrum indicum (Linn.) O.Kuntze(bh?ra?g?) Root(m?la),Justicia adhatoda Linn. Syn.: Adhatoda vasica Nees(v?s?) Leaf(patra),Milk(dugdha/k??ra/payas) Goat(Vasta / Basta),
NA2/289I Dawa-e- Baabchi Bara-e- Dama
Useful in the Treatment of following Diseases : Bronchial asthma(Zeeq-al-Nafas Shu?bi/Zeeq-al-Nafas/ Rabw),
IPC Codes : A61K 131/00, A61K 36/487, A61P 11/00, A61P 11/06, A61P 11/08, A61P 37/08
Knowledge Known Since : 100 years
Bibliography : Khazaain al Advia,
Keyword(s)/Ingredient(s): Psoralea corylifolia Linn.(Babchi) Seed(Tukhm/Bazr/Buzoor),

AT/2067 Gu?ar?sn?dileha?
Useful in the Treatment of following Diseases : Dyspnoea(?v?sa),Cough / Bronchitis(k?sa),Bronchial asthma(tamaka ?v?sa),
IPC Codes : A61K 125/00, A61K 131/00, A61K 35/78, A61K 36/00, A61K 36/185, A61K 36/28, A61K 36/67, A61K 36/74, A61K 36/87, A61K 36/9066, A61K 9/10, A61K 9/16, A61P 11/00, A61P 11/06, A61P 11/08, A61P 11/12, A61P 37/08
Knowledge Known Since : 1000 years
Bibliography : K??yapa Sa?hit? or Vrddhajivakiya Tantra ,
Keyword(s)/Ingredient(s) : Jaggery & its preparations(gu?a) ,Pluchea lanceolata Oliv. & Hiern / Alpinia galanga(Linn.)Willd.(r?sn?) Leaf(patra),Piper longum Linn.(pippal?) Fruit(phala),Vitis vinifera Linn.(dr?k??) Fruit(phala),Piper nigrum Linn.(marica) Fruit(phala),Curcuma longa(haridr?) Rhizome(prakanda),Rubia cordifolia Linn.(ma?ji??h?) Root(m?la),Sesamum indicum Linn.(tila) Seed(b?ja/ phal?sthi),

AB/718 K????dic?r?am (02)
Useful in the Treatment of following Diseases : Paediatric diarrhoea with fever(b?la jvar?tis?ra),Paediatric asthma(b?la?v?sa),Paediatric cough(Bala kasa),paediatric vomiting (b?lachardi),
IPC Codes : A61K 125/00, A61K 131/00, A61K 135/00, A61K 36/00, A61K 36/185, A61K 36/67, A61K 36/714, A61K 36/8905, A61K 9/14, A61P 1/08, A61P 1/12, A61P 11/00, A61P 11/06, A61P 11/08, A61P 11/10, A61P 11/12, A61P 11/14, A61P 29/00, A61P 31/00, A61P 37/08
Knowledge Known Since : 500 years
Bibliography : Bh?rata Bhai?ajya Ratn?kara ,?yurveda S?rasa?graha? ,
Keyword(s)/Ingredient(s) : Piper longum Linn.(pippal?) Fruit(phala),Aconitum heterophyllum Wall. ex Royle(ativi??) Root tuber(m?lakanda),Cyperus rotundus Linn. / Cyperus scariosus R. Br. / Cyperus arundinaceum Baker(mustaka, ga??ad?rv?) Stem tuber(k???akanda),Pistacia integerrima J.L.Stewart ex Brandis(karka?a???g?) Gall(k??ag?ha),

AB/720 K????dic?r?am (04)
Useful in the Treatment of following Diseases : Paediatric asthma(b?la?v?sa),Paediatric cough(Bala kasa),Paediatric pyrexia(b?lajvara),
IPC Codes : A61K 131/00, A61K 35/20, A61K 36/00, A61K 36/185, A61K 36/48, A61K 36/67, A61K 36/87, A61K 36/888, A61K 9/14, A61P 11/00, A61P 11/06, A61P 11/08, A61P 11/10, A61P 11/12, A61P 11/14, A61P 29/00, A61P 31/00, A61P 31/04, A61P 33/00, A61P 33/06, A61P 33/08, A61P 37/08, A61P 43/00
Knowledge Known Since : 100 years
Bibliography : Bh?rata Bhai?ajya Ratn?kara ,B?hat Nigha??u Ratn?kara ,?ryabhi?aka ,Nigha??uratn?kara? ,
Keyword(s)/Ingredient(s) : Piper longum Linn.(pippal?) Fruit(phala),Fagonia cretica Linn. / Alhagi pseudalhagi (Bieb.) Desv.(dhanvay?sa) St.Bark,Leaf,Flower,Fruit&Root(Pancanga),Vitis vinifera Linn.(dr?k??) Fruit(phala),Pistacia integerrima J.L.Stewart ex Brandis(karka?a???g?) Gall(k??ag?ha),Scindapsus officinalis Schott(gajapippal?) Fruit(phala),

AK/1345 ?v?saku?h?rorasa? (1)
Useful in the Treatment of following Diseases : Cough / Bronchitis(k?sa),Dyspnoea(?v?sa),Paralysis of the larynx/ a stage of Asthma / Tuberculosis or cancer of the Larynx(svaraghna),Vata-kaphaja(v?takaphaja),Disease(roga/ vy?dhi),
IPC Codes : A61K 125/00, A61K 131/00, A61K 33/36, Knowledge Known Since : 200 years
Bibliography : Rasendras?rasa?graha?,?yurveda S?rasa?graha? ,Bhai?ajya Ratn?val? ,
Keyword(s)/Ingredient(s) : trika?u,Zingiber officinale Roscoe(?rdraka, ?u??h?),Piper nigrum Linn.(marica),Piper longum Linn.(pippal?),Mercury(p?rada) Purified (?uddha),Sulphur(Gandhaka) Purified (?uddha),Aconitum chasmanthum Stapf & Holmes / Aconitum ferox Wall. ex Ser. (???gika vi?a) Root tuber(m?lakanda),Ore-borax / Sodium biborate(?a?ka?a) Purified (?uddha),Realgar/Red Arsenic Sulphide(mana??il?) Purified (?uddha),Piper nigrum Linn.(marica) Fruit(phala),
NA2/20V1 Dawa-e- Aak8
Useful in the Treatment of following Diseases : Bronchial asthma(Zeeq-al-Nafas Shu?bi/Zeeq-al-Nafas/ Rabw),
IPC Codes : A61K 131/00, A61K 135/00, A61K 36/27, A61K 36/67, A61P 11/00, A61P 11/06, A61P 11/08, A61P 37/08
Knowledge Known Since : 100 years
Bibliography : Khazaain al Advia,
Keyword(s)/Ingredient(s) : Calotropis gigantea (Linn.) Ait. f.(Madar/Aak) Vegetative buds / Young bud(Shagoofah/Ghunchah),Piper nigrum Linn.(Filfil (Safaid/Siyah)) Fruit(Samar/Fawakeh),

Above cited document from TKDl also discloses the role of five herbs as claimed in claim-1 either alone or in combination form in the treatment of respiratory disorders.Thus in view of known properties of herbs combination of herbs is obvious foe a person skilled in the art.thus Claims 1-4 of the present application lacks both 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 in the form of herbal composition (as cited by the prior art documents as described in para 1 of the report).
Claims 1-4 fall under section 3(p) of the Patents Act, 1970 as medicinal property of all the herbs 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 1922-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 SMT. SHUKLA, RAJ KUMARI/ INDIA.