1. Third Party Observations under Article 115 of EPC

TKDL third party submission under Article 115 EPC brought to the notice of examination division the prior art references on the use of Aloe barbadensis (Aloe), Bambusa arundinacea (Bamboo), Oryza sativa Linn (Rice) for the treatment of Bronchial asthma, Urticaria, Rhinitis, Nausea, Duodenal ulcer, Hyperacidity, Diseases of nervous system, Inflammation, Vomiting / Emesis from the books – Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan(Unani, Exhibit 1), Kitaab-al-Haawi-fil-Tibb, Vol.XXI Part I by Abu Bakr Mohammad.Bin Zakariyya Al-Razi(Unani, Exhibit 2), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan(Unani, Exhibit 3), Ayurveda Sarasamgrahah (Ayurveda, Exhibit 4), Kitaab-al-Haawi-fil-Tibb, Vol.V by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani, Exhibit 5), Vangasena by Vangasena (Ayurveda, Exhibit 6), Qaraabaadeen Qaadri by Mohammad Akbar Arzani(Unani, Exhibit 7), Ilaaj-al-Amraaz by Mohammad Shareef Khan(Unani, Exhibit 8), Khazaain-al-Advia, Vol II by Mohammad Najmul Ghani Khan(Unani, Exhibit 9), Vangasena by Vangasena (Ayurveda, Exhibit 10) and Agathiar vaithiam 600 by Agasthiyar (Siddha, Exhibit 11).

2. Relevant extract of EPO Examination Report

EPO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at para 4 are reproduced below.

“The third-party observation received on 21.04.2011 pursuant to Art.115 EPC; in particular documents called exhibits taken from the Traditional Knowledge Digital Library (TKDL) in the following calls into question the patentability of the subject-matter claimed for the reasons given below. Thus, said documents will be taken into account in the proceedings (Guidelines E-vi,3)   and the numbering will be adhered to in the rest of the procedure.

In particular Traditional Knowledge Digital Library (TKDL) there are several references where Aloe (Aloe barbadensis), bamboo (Bambusa arundinacea) and Rice(Oryza sativa Linn.) have been used for the treatment of  bronchial asthma, Urticaria, Rhinitis, Nausea, Duodenal ulcer, Hyperacidity, Diseases of the nervous system, Inflammation, Vomiting / Emesis (these are all under allergic diseases) through oral as well as local administration in the Indian system of medicine, since long. Hence, there does not seem to be any novelty or inventive step involved in the claims made in the present patent application.

The third party referred to 11 formulation names: abstracts are the following:

Exhibit 1:(pg. no.05-07 ) refers to a formulation containing Barbedos aloe, Indian aloe, Curacao aloe, Jaffarabad aloe (Aloe barbadensis Mill.) along with few other ingredients used for the treatment of Inflammation through oral administration.

Exhibit 2:(pg. no.08-09 ) refers to a formulation containing Barbedos aloe, Indian aloe, Curacao aloe, Jaffarabad aloe (Aloe barbadensis Mill.) as a single ingredient used for the treatment of Bronchial asthma. Mode of administration is as directed by physician.

Exhibit 3:(pg. no.10-12 ) refers to a formulation containing Barbedos aloe, Indian aloe, Curacao aloe, Jaffarabad aloe (Aloe barbadensis Mill.) along with few other ingredients used for the treatment of  Urticaria through local application.

Exhibit 4:(pg. no.13-15 ) refers to a formulation containing Barbedos aloe, Indian aloe, Curacao aloe, Jaffarabad aloe (Aloe barbadensis Mill.) along with few other ingredients used for the treatment of Vomiting / Emesis, Rhinitis through oral administration.

Exhibit 5:(pg. no. 16-18 ) refers to a formulation containing Barbedos aloe, Indian aloe, Curacao aloe, Jaffarabad aloe (Aloe barbadensis Mill.) along with one more ingredient used for the treatment of Vomiting / Emesis, Nausea through oral administration.

Exhibit 6:(pg. no.19-22 ) refers to a formulation containing bamboo (Bambusa arundinacea (Retz.) Roxb. Syn.: B. bambos Voss) along with few other ingredients used for the treatment of Duodenal ulcer, Vomiting / Emesis, Rhinitis, Diseases of nervous system through oral administration.

Exhibit 7:(pg. no. 23-25 ) refers to a formulation containing bamboo (Bambusa arundinacea (Retz.) Roxb. Syn.: B. bambos Voss) along with few other ingredients used for the treatment of Hyperacidity through oral administration.

Exhibit 8:(pg. no.26-28 ) refers to a formulation containing bamboo (Bambusa arundinacea (Retz.) Roxb. Syn.: B. bambos Voss) along with few other ingredients used for the treatment of Bronchial asthma through oral administration.

Exhibit 9:(pg. no.29-31 ) refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) as a single ingredient used for the treatment of Nausea  through oral administration.

Exhibit 10:(pg. no.32-34 ) refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredients used for the treatment of Duodenal ulcer through oral administration.

Exhibit 11:(pg. no.35-37 ) refers to a formulation containing Rice, Paddy (Oryza sativa Linn.) along with few other ingredients used for the treatment of Vomiting / Emesis, Hyperacidity  through oral administration.

The present patent application EP06716434 claims the usefulness of isoorientin isolated from aloe, bamboo or rice plant extract for  the prevention or treatment of allergic diseases, atopic disease, skin disease, cold, hyperacidity or nervous system disorder occurred by excessive histamine.

However Aloe (Aloe barbadensis), Bamboo (Bambusa arundinacea) and Rice (Oryza sativa Linn.) have been used for the treatment of  Bronchial asthma, Urticaria, Rhinitis, Nausea, Duodenal ulcer, Hyperacidity, Diseases of the nervous system, through oral as well as local administration in the Indian system of medicine, since long, as it is evident from Exhibits 1 to 11.

All of these cited prior Traditional Knowledge anticipates the subject-matter of the present claims. In addition to the aforesaid references, some other references also exist in TKDL, wherein Aloe, Bamboo and Rice have been used alone or in combination with few other ingredients for the treatment of above mentioned indications. The subject-matter of the present application is not novel nor it involves an inventive step.”

Full examination report can be referred at  EP1863498.pdf

3. Outcome of Third Party Observation and Examination Report

As the outcome of TKDL third party and other documents cited in examination report Applicant M/s Unigen, Inc. 200-1, Songjeong-ri Byeongcheon-myeon, Cheonan-si Chungcheongnamdo 330-863 / South Korea decided not to pay the renewal fee of his 6 years old application filed on 17.03.06, which he did pay for 6 years. Application was deemed to be withdrawn on 11.06.2012 and was closed on 20.9.12.