2381/CHE/2010


Ref: Examiner(s) Comments in the Examination Report Dated: 05.06.2014 on TKDL Submission Dated: 09.07.2012 in the context of Patent Application No. 2381/CHE/2010 at CGPDTM


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 Commiphora mukul (guggulu), Cyperus rotundus, Embelia ribes, Emblica officinalis (Aamla), Piper longum (Long Pepper), Piper nigrum (Black Pepper), Plumbago zeylanica, Terminalia bellirica, Terminalia chebula(Haritaki) and Zingiber officinale (ginger) as an antiobesity agent and for the treatment of obesity from the books – The Ayurvedic Pharmacopoeia of India - Part I, Vol. I by Govt of India (Ayurveda, Exhibit 1), Ayurveda Sarasamgrahah by Shri Baidyanath (Ayurveda, Exhibit 2), Kaiyadevanighantau by Kaiyadeva (Ayurveda, Exhibit 3), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani,Exhibit 4), Kitaab-al-Haawi-fil-Tibb, Vol.XXI Part I by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani, Exhibit 5), Yogaratnakarah (Ayurveda, Exhibit 6), Yogatrangini by Trimalla Bhatta (Ayurveda, Exhibit 7) and Ilaaj-al-Amraaz by Mohammad Shareef Khan (Unani, Exhibit 8).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 2 & 4 are reproduced below.



“Objections:

Claims 1-4 are not patentable u/S 3(p) of the Patents Act, 1970 as they relate to Traditional knowledge. Use of the 10 claimed herbs for treatment of obesity is traditionally known. Refer the list of documents with date of publication (PRIOR ART) In enclosed TKDL documents, D1:RG/3527, D2:RG12/1026, D3:RS6/87, D4:BA3/604, D5:AK10/384, D6:RG3/277, D7:MH1/2141.

D1: (pg. no. 04-06) refers to a formulation containing Commiphora wightii Bhandari Syn.: C. mukul as a single ingredient used for the treatment of Obesity. Mode of administration is as directed by physician.

D2: (pg. no. 07-09) refers to a formulation containing Embelia ribes as a single ingredient used for the treatment of Obesity through oral administration.

D3: (pg. no. 10-12) refers to a formulation containing Terminalia chebula Retz., Terminalia bellirica (Gaertn.) Roxb., Phyllanthus emblica Linn. Syn.: along with few other ingredients used for the treatment of Obesity through oral administration.

D4: (pg. no. 13-15) refers to a formulation containing Terminalia chebula Retz., Terminalia bellirica (Gaertn.) Roxb., Phyllanthus emblica Linn. Syn. used as an Antiobesity composition through oral administration.

D5: (pg. no. 18-19) refers to a formulation containing Piper longum Linn.,Plumbago
zeylanlca Linn., Zlnglber officlnale Roscoe along with few other ingredients used for the treatment of Obesity. Mode of administration is as directed by physician.

D6: (pg. no. 20-24) refers to a formulation containing Zingiber officinale Roscoe, Piper longum Linn" Plumbago zeylanica Linn., Embelia ribes Burm. f., Terminalla chebula Retz., Termlnalla bellirica (Gaertn) Roxb., Phyllanthus emblica Linn. Syn.: Emblica officinalls Gaertn, Commiphora wightil Bhandari Syn.: C. mukul along with few other lngredients used for the treatment of Obesity through oral administration.

D7: (pg. no. 25-28) refers to a formulation containing Piper nigrum Linn., Zinglber officinale Roscoe, Commiphora wightil Bhandari Syn.: C. mukul, Piper longum Linn. along with few other ingredients used as an Antiobesity through oral administration.

The instant application claims the usefulness of an antl-obeslty composition comprising Commiphora mukkul, Cyprerus rotundus, Embllca officinalis, Emblica ribes, Piper longum, Piper nigrum, Plumbago zeylanlca, Terminala bellarica, Terminala chebula, Zinger officinale as novel. However Commiphora wightil Bhandari Syn.: C. mukul, Cyperus rotundus Linn., Embelia ribes, Phyllanthus embllca Linn. Syn.: Embllca offlcinalls Gaertn., Piper Iongum Linn., Piper nigrum Linn., Plumbago zeylanica Linn., Terminalia belllrica, :Termi nalia chebula Retz, Zinglber officinale Roscoe have been used alone and In combination with few other ingredients as an antiobesity and for the treatment of obesity through oral administration in the Indian systems of Medicine since long, as it is evident from the references cited above. It would have been obvious to a person skilled in the art to have combined the teachings of the above mentioned documents and have arrived at the instantly claimed composition for treatment of obesity.

Not withstanding above mentioned objections, Claims 1-4 lack Inventive step u/S 2(1)(ja) of the Act in view of cited TKDL documents.”

Full examination report can be referred at 2381-CHE-2010.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 M/S The Registrar, Vels University, Chennai/ India.