1. Third Party Submission under Art 37 CFR 1.99
TKDL third party submission under Art 37 CFR 1.99 brought to the notice of examination division the prior art references on the use of Use of Punica granatum (Anaar/Pomegranate) for the treatment of Wound, Ulcer, Abrasion and as Healing agent from the books – Muheet-e-Azam Vol. IV by Mohammad Azam Khan (Unani, Exhibit 1), Khazaain-al-Advia, Vol III by Mohammad Najmul Ghani Khan (Unani, Exhibit 2), Kitaab-al-Haawi-fil-Tibb vol IV by Abu Bakr Mohammad.Bin Zakariyya Al-Razi; (Unani, Exhibit 3, 4), Muheet-e-Azam Vol. I by Mohammad Azam Khan (Unani, Exhibit 5) and Qaraabaadeen Azam wa Akmal by Mohammad Akmal Khan; (Unani, Exhibit 6).
2. Relevant Extract of USPTO Examination Report
USPTO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report are reproduced below:
“Claims 15-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Mohammad (U), in view of the Mohammad Azam Khan (V).
Mohammad teaches a composition for treating ulcers comprising a fine powder of Punica granatum (pomegranate) fruit rind and Punica granatum (pomegranate) flower.
Mohammad Azam Khan teaches a composition in the form of a medicated oily preparation comprising Punica granatum (pomegranate) seed oil solution for local administration on an affected part with malignanat ulcers (which reads on the limitations of step d).
Abu teaches a therapeutic drug/composition in the form of a thick paste for local application to a malignant ulcer comprising dried and powdered Punica granatum (pomegranate) fruit rind (peel) (which reads on the limitations o f step d).
Although the reference do not expressly teach a kit or instructions for applying the instantly claimed ingredients, nonfunctional descriptive material cannot render nonobvious an invention that would have otherwise been obvious. In re Ngai, **>367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (combining printed instructions and an old product into a kit will not render the claimed invention nonobvious even if the instruction detail a new use for the product). < Cf. In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983) (when descriptive material is not functionally related to the substrate, the descriptive material will not distinguish the invention from the prior art in terms of patentability).
It would have been obvious to orally administer the composition comprising pomegranate flower and peel used in the method taught by Mohammad and to apply a composition comprising a Pomegranate oil extract and/or pomegranate peel powder directly to an ulcer because at the time the invention was made, it was known that a tablet comprising pomegranate flower and peel could be orally administered to treat ulcers and that a medical composition pomegranate oil extract and/or pomegranate peel powder could be directly administered to an ulcer as clearly taught by Mohammad, Mohammad Azam Khan and Abu.
Thus, an artisan of ordinary skill would reasonably expect that administering a composition comprising pomegranate flower and peel and to then apply a composition comprising a pomegranate oil extract and/or pomegranate peel powder directly to an ulcer would provide an even more effective, faster and more complete treatment for ulcers. This reasonable expectation of success would motivate the artisan to employ a composition comprising pomegranate flower and peel in combination with a composition comprising a pomegranate oil extract and/or pomegranate peel powder directly to an ulcer more effectively treat ulcers based upon the beneficial teachings of Mohammad, Mohammad Azam Khan and Abu.
Moreover, it would have been merely a matter of judicious selection to one of ordinary skill in the art at the time the invention was made to modify the referenced composition comprising pomegranate flower and peel to provide an atomized composition because it would have been well in the purview of one of ordinary skill in the art practicing the invention to pick and choose a suitable form of oral administration for more direct and effective treatment of oral ulcers. Thus, the claimed invention is no more than the routine optimization of a result effect variable.
Based upon the beneficial teachings of the cited references, the skill of one of ordinary skill in the art, and absent evidence to the contrary, there would have been a reasonable expectation of success to result in the claimed invention.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art of the time the invention was made, especially in the absence of evidence to the contrary.”
Full examination report can be referred at 20100291249.pdf
3. Outcomes of Third Party Submission & Examination Report
As the outcome of TKDL third party and other documents cited in examination report, the applicant decided to amend the claims 15-18 on 14-Aug-12. The examiner again rejected the claims 15-18, 27 & 28 on 23.10.2012. The Application was abandoned on 17.05.2013.