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 Olea europaea (olive) for the treatment of Fatigue, Cramp/Convulsion/Spasm, Bruise / Injury and as an Analgesic, Relaxant, Tonic and Nutritive from the books – Al-Jaam'e-li-Mufradaat-al-Advia-wal-Aghzia, Vol. II by Ziya Al- Din Abdullah Ibn Al- Baitar (Unani, Exhibit 1), Kaamil-al-Sena'ah, Part II by Ali Ibn-e-Abbaas Majoosi (Unani, Exhibit 2), Kitaab-al-'Umdah-fil-Jeraahat, Part II by Aminuddaulah Abul Farj Ibn Al-Quff Maseehi (Unani, Exhibit 3), Kaamil-al-Sena'ah, Part I by Ali Ibn-e-Abbaas Majoosi (Unani, Exhibit 4:), Kitaab-al-'Umdah-fil-Jeraahat, Part I by Aminuddaulah Abul Farj Ibn Al-Quff Maseehi (Unani, Exhibit 5), Al-Qaanoon-fil-Tibb, Vol. II by Abu Ali Ibn-e-Sina (Unani,Exhibit 6) and Kitaab-al-Haawi-fil-Tibb,Vol.I by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani,Exhibit 7).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 3, 5 & 6 are reproduced below.

“Claims 1-10 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 duplication of traditionally known medicinal property of olive plant for the treatment of muscle pain, injury or soreness.

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 for treatment of muscle injury, pain, spasm and fatigue-

(i) Name of formulation- Dohn-ul- Babunaj; formulation ID- JA3/170 [see annex. D1 (i)] refers to a formulation containing olive (Olea europaea Linn.) along with one other ingredient used for the treatment of fatigue and as an analgesic and relaxant through oral administration.

(ii) Name of formulation- Joshaanda-e- Muhallil; formulation ID- AH3/558A [see annex. D1 (ii)] refers to a formulation containing olive (Olea europaea Linn.) along with few other ingredients used for the treatment of fatigue and as an analgesic through oral administration.

(iii) Name of formulation- Roughan -e- Habb -ul- Ghaar; formulation ID- MA2/632 [see annex. D1 (iii)] refers to a formulation containing olive (Olea europaea Linn.) along with few other ingredients used for the treatment of fatigue. Mode of administration is as directed by physician.

(iv) Name of formulation-Zaitoon-al- Zait; formulation ID- AN4/76A [see annex. D1 (iv)] refers to a formulation containing olive (Olea europaea Linn.) as a single ingredient used a nutritive. Mode of administration is as directed by physician.

(v) Name of formulation- Zaitoon; formulation ID- MA1/98 [see annex. D1 (v)] refers to a formulation containing olive (Olea europaea Linn.) as a single ingredient used a tonic and nutritive. Mode of administration is as directed by physician.

(vi) Name of formulation- Ramaad-ul- Teen; formulation ID- AH1/309C [see annex. D1 (vi)] refers to a formulation containing olive (Olea europaea Linn.) along with few other ingredients used for the treatment of bruise /injury through oral administration.

(vii) Name of formulation- Ghiza -e- Dawaai Bara-e- Tashannuj; formulation ID- AA1/544 [see annex. D1 (vii)] refers to a formulation containing olive (Olea europaea Linn.) along with few other ingredients used for the treatment of cramp/convulsion/spasm through oral administration.

(viii) Name of formulation- Abzan Bara-e-Tashannuj; formulation ID- AA1/558C [see annex. D1 (viii)] refers to a formulation containing olive (Olea europaea Linn.) as a single ingredient used for the treatment of cramp/convulsion/spasm.

(ix) Name of formulation- Marookh Bara-e-Tashannuj Imtilai; formulation ID- AA1/566A [see annex. D1 (ix)] refers to a formulation containing olive (Olea europaea Linn.) as a single ingredient used for the treatment of cramp/convulsion/spasm.

(x) Name of formulation- Masooh Namak Barae Thakaan; formulation ID- AH1/671E [see annex. D1 (x)] refers to a formulation containing olive (Olea europaea Linn.) as a single ingredient used for the treatment of fatigue.
D1-D4 discloses the use of olive extracts or compounds found in olive extracts for the same therapeutical use as claimed in the present application and D5-D6 discloses the pharmaceutical and nutraceutical compositions of hydroxytyrosol or olive extract. As per D8 and D9 antioxidant compounds used to reduce muscle fatigue are active also to suppress the rise in lactic acid value upon physical exercise hence in the light of cited documents D1-D9 it is obvious for a person skilled in the art to use the olive extract for promoting muscle health.

As per guiding principle 1 of ?Guidelines for Processing of Patent Applications Relating to Traditional Knowledge and Biological Material?, as issued by CGPDTM, if the subject-matter as claimed relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be considered as novel and/or inventive when use of such plants is pre-known as part of teachings of Traditional Knowledge. When the subject-matter of claims relates to extracts of plant materials containing undefined active ingredients, such claims cannot be said to be novel if the use of such plants or plant materials is pre-known as a part of teaching of TK. In the present case olive plant is traditionally known for its medicinal properties for the treatment of muscle injury, pain, spasm and fatigue and also the constituents of the extract as claimed is not defined hence the claims lack novelty and inventive step in view of the cited documents. Further as per guiding principle-3 of said guidelines, in case an ingredient is already known for the treatment of a disease, then it creates a presumption of obviousness that a combination product comprising this known active ingredient would be effective for the treatment of same disease. In the claimed invention olive extract is traditionally known independently and in combination with each other for the treatment of muscle injury, pain, spasm and fatigue then it is necessarily expected that a combination comprising the said known plant extract along with known other components must be effective for treating such diseases as long as no surprising (superior) effect of the claimed composition vis-a-vis the already known products comprising extract of olive is shown, inventive merits cannot be acknowledged.

Also as per guiding principle 5 of above stated guidelines in case multiple ingredients are known to have the same therapeutic activity as per traditional knowledge, taking out one single component out of them cannot be considered as inventive. D1 discloses several multicomponent formulations wherein olive has been used along with few other ingredients for the treatment of muscle injury, pain, spasm and fatigue therefore it is obvious that one single component namely olive out of the said formulations again would have the same therapeutic activity.”

Full examination report can be referred at 2946-delnp-2009.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.