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 Argyreia nervosa, Azadirachta indica (neem), Acacia arabica, Cinnamomum zeylanicum (cinnamon), Syzygium aromaticum (clove) and Mentha piperita (Peppermint) as an Anti-inflammatory, for cleansing of mouth/oral cavity and Teeth strengthening and for the treatment of Toothache, Gingivitis, Loose teeth, Sensitive teeth, Diseases of teeth/ Dental diseases, Toothache / Odontodynia / Cracked tooth, Pyorrhoea alveolaris and Spongy gums/bleeding gums from the books – Khazaain-al-Advia by Mohammad Najmul Ghani Khan (Unani, Exhibit 1 & 3), Bhavaprakasa by Bhavamisra (Ayurveda, Exhibit 2), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani, Exhibit 4), Agathiar vaithiam by Agasthiyar (Siddha, Exhibit 5), Kitaab-al-Haawi-fil-Tibb by Abu Bakr Mohammad.Bin Zakariyya Al-Razi(Unani, Exhibit 6), Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 7 & 8).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 1 & 2 are reproduced below.

“Objections :

Subject-matter claimed in claims 1-20 is not patentable u/s 3(e) of Patents Act;

Subject- matter claimed in claims 1-20 is not patentable u/s 3(p) of Patents Act & also lacking inventive step under section 2(1) (j) of the Act in view of the following cited documents.;
Your attention has been drawn to the pregrant opposition filed under section 25 (1) of the Act in this application.

Documents & Reference.

1.Mohammad Najmul Ghani Khan; Khazaain-al-Advia, Vol II (20th century AD), Nadeem Yunus Printer / Sheikh Mohd Basheer & Sons, Lahore, 1911 AD Pg 844
Formulation ID; AN2/846B
Formulation Name: Dawa Barae Waram

2.Bhavamisra; Bhavapraka?a – Edited & translated by Brahmashankara Misra & RupaLalji Vaisya, Part-I :
Chaukhambha Sanskrit Sansthan, Varanasi, Edn, 9th, 1999, [Time of origin 16th century] Pg 110
Formulation ID; RS/3007C
Formulation Name: Dantakurcika (03)

3.Mohammad Najmul Ghani Khan; Khazaain-al-Advia, Vol III (20th century AD), Nadeem Yunus Printer / Sheikh Mohd Basheer & Sons, Lahore, 1926 AD Pg 993
Formulation ID; JA6/973BI
Formulation Name: Joshaanda Bara-e-Taqviyat-e- Asnaan Va Lassah

4Mohammad Akmal Khan; Qaraabaadeen Azam wa Akmal (20th century AD), Matba Siddiqi, Delhi / Matba Mustafai, Delhi, 1909 AD Pg 690
Formulation ID; AH5/3503 A
Formulation Name: Mazmazah Musakkin Dard-e-dandaan

5.Agasthiyar; Agathiar vaithiam 600. Pub & Ed. Anonymous, Pg 30
Formulation ID; PD04/36
Formulation Name: Karuvel Kopalippu

6.Abu Bakr Mohammad, Bin Zakariyya Al-Razi; Kitaab-al-Haawi-fil-Tibb, Vol JII (9th century AD), Bayerah-al Ma”aarif Usmania, Hyderabad, (Second Edition) 1977 AD Pg 205
Formulation ID; AA3/912
Formulation Name: Sanoon-e-Mujaffif

7.Resatantrasarah Evam Siddhaprayogasaritgrahah:- part II; Krishan Gopal Ayurveda Bhawan;Edn 8th; 1990 [This book contains back
References from 1000 B.C. to 20th 20th century] Pg 504-505
Formulation ID; RS21/630
Formulation Name: Krsna Manjana

8.Rasatantrasarah Evan Siddhaprayogasamgrahah:- part i1; Krishan Gopal Ayurveda Bhawan: Edn 8th; 1990 [This book contains back
References from 1000 B.C. to 20th century] Pg 504
Formulation ID; RS21/628
Formulation Name: Dantaraksaka Manjana

Exhibit 1 ;(pg. no. 4-5) refer to a formulation containing Argyreia nervosa (Burm. F.) Boj. / A. speciosa Sweet as a single ingredient used as an Anti-inflammatory. Mode of administration is as directed by physician.

Exhibit 2 :(pg. no. 6-7) refers to a formulation containing Azadrachta indica A. Juss, as a single ingredient used for cleansing of mouth/oral cavity and for treatment of Diseases of teeth/Dental through local application.

Exhibit 3 :(pg. no. 8-14) refers to a formulation containing Azadirachta indica A. Juss, as a single ingredient used for Teeth strengthening through local application.

Exhibit 4 :( pg. no. 15-16) refers to a formulation containing Acacia Arabica/nillotica Willd, as a single ingredient used for the treatment of Toothache and Gingivitis through local application.

Exhibit 5: (pg.no. 17-19) refers to a formulation containing Acacia Arabica/nillotica Willd, along with few other ingredients used for the treatment of Loose teeth, Diseases of teeth/Dental diseases and Toothache through local application.

Exhibit 6: (pg. no. 20-21) refers to a formulation containing Acacia Arabica/nillotica Willd, along with few other ingredients used for the treatment of Sensitive teeth through local application.

Exhibit 7: (pg. no.22-24) refers to a formulation containing Acacia Arabica/nillotica willd., Syzyglum aromaticum and Menthapiperita along with few other ingredients used for the treatment of Toothache / Odontodynia / Cracked tooth, Pyorrhoea alvcolaris, Toothache, Spongy gums/ bleeding gums through local application.

Exhibit 8: (pg. no.25-28) refer to a formulation containing Cinnamomum zeylanicum Blume, Syzygium arornaticum, Acacia Arabica/nillotica Willd. and Mentha piperita along with few other ingredients used for the treatment of Diseases of teeth/ Dental diseases through local application.

The alleged patent application 1947/MUM/2008 claims the usefulness of a dentifrice formulation comprising: bioactive material extract derived from plants belonging to the genus Argyreia and further comprising at least one additional plant material selected from a group consisting of Azadirachta indica and Acacia Arabica and flavoring agent from a group consisting of vanillin, sage, marjoram, parsley oil, spearmint oil, wintergreen oil, peppermint oil, clove oil, bay oil, anise oil, eucalyptus oil, citrus oils and fruit oils. However, Argyreia nervosa (Burm.F.) Boj. / A. speciosa Sweet, Azadirachta india A. Juss., Acacia Arabica/nillotica Willd., Cinnamomum zeylanicum, Syzygium aromaticum and Mentha, plperita have been used alone and in combination with few other ingredients as an Anti-inflammatory, for cleansing of mouth/oral cavity and Teeth strengthening and also for the treatment of Toothache, Gingivitis, Loose teeth. Sensitive teeth, Diseases of teeth/ Dental diseases. Toothache / Odontodynia / Cracked tooth, Pyorrhoea alveolaris and Spongy gums/bleeding gums through local application or as directed by the physician in the Indian systems of Medicine, since long, as is evident from exhibits cited from the books namely, Khazaain-al-AdNia by Mohammad Najmul Ghani Khan (Unani, Exhibit 1: pg. no. 4-5), Bhavaprakasa by Bhavamisra ( Ayurveda, Exhibit 2: pg. no. 6-7), Khazaain-al-Advia by Mohammad Najmul Ghani Khan (Unani, Exhibit 3: pg. no. 8-14), Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan (Unani, Exhibit 4: pg. no. 15-16), Agathiar vaithiam by Agasthiyar (Siddha, Exhibit 5: pg. no. 17-19), Kitaab-al-Haawi-fil-Tibb by Abu Bakr Mohammad. Bin Zakariyya Al-Razi(Unani, Exhibit 6: pg. no. 20-21), Rasatantrasarah Evam Siddhapryogasamgrahah (Ayurveda, Exhibit 7: pg. no. 22-24) and Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 8: pg. no. 25-28). In addition to the aforesaid, references, some other references also exist in TKDL wherein aforesaid plants have been used alone and in combination with few other ingredients for the treatment of above mentioned indications and actions. Hence the said application 1947/MUM/2008 is not novel as per the cited prior art and does not involve any inventive step, therefore cannot qualify for the grant of patent rights.
(For details refer exhibits filed with pregrant opposition).”

Full examination report can be referred at 1947-MUM-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.