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 Mucuna pruriens, Withania somnifera (Asvagandha), Hygrophila auriculata, Astercantha longifolia, Myristica fragrans (Nutmeg), Tribulus terrestris (caltrop), Curculigo orchioides and Anacyclus pyrethrum for the treatment of Oligospermia, Impotency, Male Infertility, Premature Ejeculation, Nocturnal emission, Spermatorrhoea and used as Aphrodisiac, Semen retaining from the books – Aryabhisaka by Smkaradajisastripade (Ayurveda, Exhibit 1), Rasayoga Sagara (Ayurveda, Exhibit 2), Rasatarangini by Sadanandasarma (Ayurveda, Exhibit 3), Bharata Bhaisajya Ratnakara (Ayurveda, Exhibit 4 & 5), Bayaaz-e-Kabir, Vol. II by Mohammad Kabiruddin (Unani, Exhibit 6), Khazaain-al-Advia, Vol III by Mohammad Najmul Ghani Khan (Unani, Exhibit 7), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani, Exhibit 8), The Ayurvedic Pharmacopoiea of India (Ayurveda, Exhibit 9) and Dhanvantarinighantauh by Mahendra Bhaugika (Ayurveda, Exhibit 10).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 2 & 3 are reproduced below.

“Subject matter of the claims does not constitute an invention u/s 2(1) (j) as the claims lack novelty and inventive step in view of cited documents-

D1: Database TKDL- Following traditionally known formulations retrieved from TKDL comprising claimed plants used as aphrodisiac and treatment of various sexual disorders-

(i) Name of formulation- Kharjura Purana Paka; formulation ID- RS17/2367 [published in Smkaradajisastripade; Aryabhisaka - Gujarati Edited (Hindustana No Vaidyaraja) Translation by Hariknshna Bhagwan Lal Vyas; Sastu Sahitya Vardhaka Karyalaya, Bhadra, Ahmedabad, Edn. 12th, 1957, page 176-177] refers to a formulation containing Mucuna pruriens Linn, Withania somnifera Linn, Hygrophila auriculata Schum, Astercantha longifolia Linn, Myristica fragrans Houtt, Tribulus terrestris Linn., Curculigo orchioides Gaertn withania somnifera Linn and Anacyclus pyrethrum along with few other ingredients used for the treatment of seminal disorders, oligospermia and impotency through oral administration.

(ii) Name of formulation- Puspadhanvarasah(5); formulation ID- VS/205 [published in Rasayoga Sagara - Compiled and Translated by Vaidya Pandita Hariprapanna Ji, Vol.-II: Krishnadas Academy, Varanasi, Edn. Reprint, 1998. (This book contains back references from 1000 B.C.to 20th century), page 59] refers to a formulation containing Mucuna pruriens Linn, Withania somnifera Linn, Hygrophila auriculata Schum, Astercantha longifolia Linn, Myristica fragrans Houtt, Tribulus terrestris Linn., Curculigo orchioides Gaertn. and Anacyclus pyrethrum along with few other ingredients used as aphrodisiac through oral administration.

(iii) Name of formulation- Trailokyasamohana Rasah; formulation ID- AK1/762 [published in Sadanandasarma; Rasatarangini- , Kasinathsastri, Motilal Banarasidas, Varanasi, Ed. 11th 1979 (Reprinted-Delhi, 2000), page 726-727] refers to a formulation containing Tribulus terrestris Linn. and Mucuna pruriens Linn. along with few other ingredients used for the treatment of male infertility and used as semen retaining, aphrodisiac through oral administration.

(iv) Name of formulation- Narikelapakah; formulation ID- RG/657 [published in Bharata Bhaisajya Ratnakara- Compiled by Naginadasa Chaganalala Saha, Translated by Gopinath Gupta - Vol.-III: B. Jain Publishers, New Delhi, Edn. 2nd. Reprint, August 1999 (This book contains back references from 1000 B.C.to 20th century), page 183] refers to a formulation containing Mucuna pruriens Linn, Hygrophila auriculata Schum, Astercantha longifolia Linn, Myristica fragrans Houtt, Tribulus terrestris Linn, and Anacyclus pyrethrum along with few other ingredients used as aphrodisiac and used for the treatment of male infertility through oral administration.

(v) Name of formulation- Vajikarovatakah; formulation ID- RS/2173 [published in Bharata Bhaisajya Ratnakara- Compiled by Naginadasa Chaganalala Saha,Translated by Gopinath Gupta - Vol.-IV: B. Jain Publishers, New.Delhi, Edn. 2nd. Reprint, August 1999 (This book contains back references from 1000 B.C.to 20th century), page 817,818] refers to a formulation containing Mucuna pruriens Linn, Hygrophila auriculata Schum, Astercantha longifolia Linn, Myristica fragrans Houtt, Tribulus terrestris Linn, along with few other ingredients used for the treatment of oligospermia , impotency and male infertility and used as aphrodisiac through oral administration.

(vi) Name of formulation- Habb-e- Mumsik; formulation ID- MA3/165 [published in Mohammad Kabiruddin; Bayaaz-e-Kabir, Vol. II (Compiled), Daftar-al- Maseeh, Karol Bagh, New Delhi, 1938 AD Pg 54] refers to a formulation containing Myristica fragrans Houtt and Anacyclus pyrethrum DC along with few other ingredients used for the treatment of premature ejaculation through oral administration.

(vii) Name of formulation- Safoof Bara-e-jiryan; formulation ID- JA6/588J1 [published in Mohammad Najmul Ghani Khan; Khazaain-ai-Advia, Vol III (20th century AD), Nadeem Yunus Printer/Sheikh Mohd Basheer & Sons, Lahore, I 926 AD Pg 608] refers to a formulation containing Tribulus terrestris Linn along with one other ingredient used for the treatment of premature ejaculation, spermatorrhoea and nocturnal emission through oral administration.

(viii) Name of formulation- Halwa Muqawwi Baah; formulation ID- BA3/642 [published in Mohammad Akmal Khan; Qaraabaadeen Azam wa Akmal (20th century AD), Matba Siddiqi, Delhi/Matba Mustafai, Delhi, 1909 AD Pg 98] refers to a formulation containing Mucuna pruriens Linn and Myristica fragrans Houtt along with one other ingredient used for the treatment of premature ejaculation and used as aphrodisiac through oral administration.

(ix) Name of formulation- Atmagupta ( Bija ); formulation ID- RG/3669 [published in The Ayurvedic Pharmacopoiea of India- Part 1, vol. III Ed. First 200l, Govt. of India, Ministry of Health & Family Welfare (This book contains back references from 1000 B.C.to 20th century), pages 23-24] refers to a formulation containing Mucuna pruriens Linn as a single ingredient used for the treatment of male infertility and used as aphrodisiac. Mode of administration is as directed by physician.

(x) Name of formulation- Jatiphala; formulation ID- RG/3533 [published in Mahendra Bhaugika; Dhanvantarinighantauh - Edited by P.V. Sharma; Translated by Guru Prasad Sharma; Chaukhambha Orientalia, Varanasi, Edn. 3rd, 2002 Pg 97] refers to a formulation containing Myristica fragrans Houtt as a single ingredient used as aphrodisiac. Mode of administration is as directed by physician.

(xi) Name of formulation- Vallabhagutika; formulation ID- RS/1685 [published in Bharata Bhaisajya Ratnakara- Compiled by Naginadasa Chaganalala Saha,Translated by Gopinath Gupta - Vol.-IV: B. Jain Publishers, New.Delhi, Edn. 2nd. Reprint, August 1999 (This book contains back references from 1000 B.C.to 20th century), page 609] refers to a formulation containing Mucuna pruriens Linn, Hygrophila auriculata Schum, Myristica fragrans Houtt, Tribulus terrestris Linn, Curculigo orchiodides Gaertn. and Anacyclus pyrethrum along with few other ingredients used as aphrodisiac and used for the treatment of impotency.

(xii) Name of formulation-Kesarpaka; formulation ID- AB/811 [published in Bharata Bhaisajya Ratnakara- Compiled by Naginadasa Chaganalala Saha,Translated by Gopinath Gupta - Vol.-I: B. Jain Publishers, New.Delhi, Edn. 2nd. Reprint, August 1999 (This book contains back references from 1000 B.C.to 20th century), page 249] refers to a formulation containing Mucuna pruriens Linn, Myristica fragrans Houtt, Tribulus terrestris Linn, Withania somnifera and Anacyclus pyrethrum along with few other ingredients used as aphrodisiac.

(xiii) Name of formulation- Majoon-e-Kharoos; formulation ID- MH1/3380A [published in Ilaj-al-Amraaz (18th century AD), Afzal-al-Matbe, Barqi Press, Delhi, 1921 AD] refers to a formulation containing Mucuna pruriens Linn, Myristica fragrans Houtt, Tribulus terrestris Linn, Curculigo orchiodides Gaertn. and Anacyclus pyrethrum along with few other ingredients used as aphrodisiac.

(xiv) Name of formulation- Musalipaka; formulation ID- VS/594 [published in Rasatantrasara Evam Siddhaprayogasangrah part II; Krishna Gopal Ayurveda Bhawan; edn. 8th, 1990 (this book contains back references from 1000B.C. to 20th century] refers to a formulation containing Mucuna pruriens Linn, Myristica fragrans Houtt, Tribulus terrestris Linn, Withania somnifera and Anacyclus pyrethrum along with few other ingredients used as aphrodisiac and for the treatment of impotency.

(xv) Name of formulation-Brihat Musalipak; formulation ID- BD/07 [published in Yogacintamani/Sarasangraha, translated by Dattaram Caube, Khemraj Srikrishnadas, Srrivyankateshwar press, Mumbai, edn. Nov. 2006, page 25-27] refers to a formulation containing Mucuna pruriens Linn, Myristica fragrans Houtt, Tribulus terrestris Linn, Withania somnifera and Anacyclus pyrethrum along with few other ingredients used as aphrodisiac and for the treatment of impotency.

           The cited documents D1-D5 disclose all the plants, independently or in combination with each other, which are present in claimed herbal formulation along with their use as aphrodisiac and in the treatment of impotency.
As per guiding principle-2 of ?Guidelines for Processing of Patent Applications Relating to Traditional Knowledge and Biological Material? issued by CGPDTM if combination of plants with known-therapeutic effect with further plants with the same known-therapeutic agents wherein all plants are previously known for treating the same disease is considered to be an obvious combination and as per guiding principle-6 of said guidelines in case individual ingredients are already known for the treatment of a disease as a part of Traditional Knowledge, then it is obvious that a combination product comprising these known ingredients with further plants with the same known therapeutic effect would be more effective than each of the medicinal plants when applied separately (additive effect). In the light of said principles claimed invention lacks inventive step as it is obvious for a person skilled in the art to combine the claimed plant parts each of which is traditionally known, either independently or in combination with each other as an aphrodisiac (as evident from the cited documents). Further as per guiding principle 4 of above said guidelines- discovering the optimum or workable ranges of traditionally known ingredients by routine experimentation is not inventive. In case of present invention the claimed optimum or workable range of ingredients (claims 5-6) cannot be considered to be inventive since the selection of optimum or workable range from already known ranges of the ingredients in the disclosed formulations (see D1-D5) is well within the expectation of a person skilled in the art.

(i) Claims 1-15 fall within the scope of such clause (p) of section 3 of Indian Patents Act as claimed invention is based on traditional knowledge (as evident from the cited documents) and relates to aggregation or duplication of traditionally known medicinal property, i.e. use as aphrodisiac, of Mucuna pruriens, Tribulus terrestris, Myristica fragrans, Withania somnifera, Anacyclus pyrethrum, Astercantha longifolia and Curculigo orchioides independently or in combination with each other.”

Full examination report can be referred at 2749-DEL-2008.pdf

3. Current Status & 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.