Ref. No POD/Application No/ 9382/DELNP/2010 Date of Dispatch/ 17/03/2017

Transcription

1 Ref. POD/Application / 9382/DELNP/2010 Date of Dispatch/ 17/03/2017 To REMFRY & SAGARATTORNEYS-AT-LAW REMFRY HOUSE MILLENNIUMPLAZA SECTOR 27, GURGAON , INDIA. remfry-sagar@remfry.com Subject: Examination report under sections 12 & 13 of the Patents Act, 1970 and the Patents Rules, Please find enclosed herewith an Examination Report in respect of the above mentioned application. This report is issued with reference to the request for examination dated 27/06/2012. The instant application shall be deemed to have been abandoned under Section 21(1) of the Patents Act, 1970, unless all the requirements raisedin this report are complied within the period mentioned in para 1 above. You are advised to file thereply at the earliest for early disposal. Enclosed: As above MANOJ MADHAVAN Controller of Patents NOTE: This is an electronically generated report. All communications should be sent to the Controller of Patents at the above mentioned address. Examination Report Page 1 of 8

2 Application Number 9382/DELNP/2010 Date of filing 31/12/2010 Date of priority 02/07/2008 Date of PCT International Application 20/06/2009 Applicant Agent BAYER INTELLECTUAL PROPERTY GMBH, RAYCHAUDHURY HRISHIKESH Request for Examination no. & date 5584/RQ-DEL/ /06/2012 Date of Publication 09/03/2012 This examination report consists of four parts, namely summary of the report, detailed technical report, formal requirements and documents on record. PART-I: SUMMARY OF THE REPORT Sl.. Requirements under the Act Claim Numbers Remarks velty 3,4 1,2 1. Invention u/s 2(1)(j) Inventive step NONE 1-4 Industrial Applicability n-patentability u/s 3 (if yes, specify section3(a-p)) 1-4 d,e 3. n-patentability u/s 4 4. Unity of invention u/s 10 (5) Sufficiency of disclosure u/s 10 (4) (Specify /) Reference to co-pending/foreign application(s) required (Specify /) yes 7. Claims [u/s 10(5) & 10(4) (c)] Clarity / Conciseness 1,2 Page 2 of 8

3 Definitive Supported by description Scope 3,4 3,4 8. Other requirement(s): Claims 1 and 2 are use claims, hence the subject matter of the said claims does not constitute an invention under section 2(1)j of The Patents Act 1970, since the claimed subject matter neither pertains to a product nor to a process. PART-II: DETAILED TECHNICAL REPORT A. List of documents cited: Relevant Sl.no Details of documents Priority date description (page and Publication date paragraph no.) of cited Relevant claims Claims of of cited alleged document invention document A Patent literature 1. D1: WO (A2) 19/10/2006 claims 10,11,23, Relevant Sl.no Details of documents Priority date description (page and Publication date paragraph no.) of cited Relevant claims Claims of of cited alleged document invention document B n-patent literature Page 3 of 8

4 Harder, Achim, et al. "Cyclooctadepsi peptides an anthelmintically active class of compounds 1. exhibiting a novel mode of title and abstract 4 action." International journal of antimicrobial agents 22.3 (2003): Docampo, Roberto, and Andres OM Stoppani. "Generation of superoxide anion and 2. hydrogen peroxide induced by title and abstract 1,2 nifurtimox in Trypanosoma cruzi." Archives of biochemistry and biophysics (1979): B. Detailed observations on the requirements under the Act: NOVELTY: (i) Claim(s) 1,2 lack(s) novelty, being anticipated in view of disclosure in the document cited above under reference for the following reasons: Page 4 of 8

5 The application does not meet the requirement of section 2 (1) (j) of the Patents Act 1970 in that the subject matter of claims 1 and 2 is not novel in view of D1: WO A2 since D1 discloses the use of Nifurtimox in pharmaceutical preparations for the treatment of diseases caused by Giardia species, particularly Giardia lamblia (refer claims 40 and 51 of D1). Thus the subject matter of claims 1 and 2 is rendered not novel. This observation is made without prejudice to the fact that the subject matter of claims 1 and 2, which relates to the "use" of Nifurtimax, does not constitute an invention u/s 2(1)j of the Act. INVENTIVE STEP: (ii) Claim(s) 1-4 lack(s) inventive step, being obvious in view of teaching (s) of cited document(s) above under reference for the following reasons: Given the lack of novelty in view of D1, the subject-matter of claims 1 and 2 cannot be considered as involving an inventive step either as required under section 2 (1) (ja) of The Patents Act Further, involvement of an inventive may not be acknowledged for the claims 3 and 4 in view of the disclosure of documents D1 and D2: Harder, Achim, et al. "Cyclooctadepsipeptides an anthelmintically active class of compounds exhibiting a novel mode of action." International journal of antimicrobial agents 22.3 (2003): The use of nifurtimox for treating protozoan infections including giardiasis is disclosed in D1. The anthelmintic activity of cyclooctadepsipeptides, such as PF1022A and emodepside, is known from D2. In view of the disclosure in D1 and D2, it would have been within the ambit of the common technical knowledge of a person skilled in the art to combine nifurtimox with an anthelmintic to obtain the composition of present claims 3 and 4 which is effective against a protozoan as well as a helminth. Further no unexpected/surprising and/or enhanced or synergistic technical effect arising out of the said combination is demonstrated to have been attained. Hence, involvement of an inventive step cannot be acknowledged for claims 3 and 4. INDUSTRIAL APPLICABILITY: (iii) Claim(s) lack(s) industrial applicability for the following reasons: t Applicable NON PATENTABILITY: (iv) Claim(s) 1-4 are statutorily non-patentable under the provision of clause ([d,e) of Section 3 for the following reasons: (1) The use of nifurtimox against protozoan species of the genus Trypanosoma is already known in the art as admitted by the applicant in the description and also evident from the document D3: Docampo, Roberto, and Andres OM Stoppani. "Generation of superoxide anion and hydrogen peroxide induced by nifurtimox in Trypanosoma cruzi." Archives of biochemistry and biophysics (1979): In view of this, the subject matter of claims 1 and 2 relates to the mere new use (against a different protozoan, Giardia sp.) of a known substance and therefore is not patentable under section 3 (d) of The Patents Act, 1970.(2)The subject matter of claims 3 and 4, in view of the disclosure in D1 and D2, are not patentable under section 3(e) of The Patents Act, 1970 since the claimed composition appears to have been obtained by a mere admixture resulting only in an aggregation of the properties of the components, an antiprotozoan compound Nifurtimox and an anthelmintic drug, without any synergistic effect. (v) Claim(s) are not allowable under section 4 of the Patents Act, t Applicable UNITY OF INVENTION: Page 5 of 8

6 (vi) Claim(s) lack(s) unity of invention as the claims do not relate to a single invention or to a group of inventions linked so as to form a single inventive concept: t Applicable (vii) Claim(s) 3 and 4 of the instant application conflict(s) with claim(s)7 and 8 respectively of co-pending application no. 462/DELNP/2011 SUFFICIENCY OF DISCLOSURE: (viii) Claim(s) are not fairly based on the matter disclosed in the specification or not supported by the disclosure in the specification for the following reasons: The composition claimed in claims 3 and 4 is not sufficiently supported and enabled by the description in that not a single working example has been provided for the claimed composition of nifurtimox and an anthelmintic (particularly a Cyclooctadepsipeptides like PF1022 and emodepside). Thus the complete specification does not disclose the best method of performing the invention. Hence, the requirement under sections 10(4) (a) and (b) and 10(5) of The Patents Act, 1970 is not met. (ix) The complete specification does not fully and particularly describe the invention and its operation and the method by which it is to be performed in respect of: t Applicable (x) The specification does not disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection for the following reasons: t Applicable (xi) Abstract: t Applicable (xii) Title of Invention: t Applicable (xiii) Drawings are not prepared in accordance with the provisions of Rule 15 of the Patents Rules, 2003 for the following reasons: t Applicable (xiv) Information of source and geographical origin of biological material used in the invention: t Applicable (xv) Details of depositing the biological material to an International Depository Authority under the Budapest Treaty: t Applicable SCOPE: Page 6 of 8

7 (xvi) Claim(s) does/do not define the scope of invention for which the protection is claimed for the following reasons: t Applicable CLARITY AND CONCISENESS: (xvii) Claim(s) 1,2 are not clearly worded in respect of: Claims 1 and 2 are use claims, hence the subject matter of the said claims does not constitute an invention under section 2(1)j of The Patents Act 1970, since the claimed subject matter neither pertains to a product nor to a process. DEFINITIVENESS: (xviii) Claim(s) 3,4 do not sufficiently define the invention for the reasons as follows: Claims 3 and 4 do not sufficiently define the alleged invention. Since a composition is claimed, all the characteristic and distinguishing features of the composition viz. the constituents and their respective percentage constitution shall be given clearly in the main claim to meet the requirements u/s 10 (5) of the Patents Act OTHERS REQUIREMENTS: (xix) Claims 3 and 4 of the instant application conflict with claim 7 and 8 respectively of co-pending application no. 462/DELNP/2011. PART-III: FORMAL REQUIREMENTS Objections Endorsement by /Assignment from Inventor Translation of Pr.Document (Certified Copy etc.) Remarks The application does not meet the requirement of section 7(2) of The Patents (Amendment) Act, 2005 in that the proof of right to make the application in the form of assignment or endorsement from the inventors has not been filed along with the application or within 6 months from the date of filing of the application. The international application PCT/EP09/ is neither filed nor published in English, therefore you are required to submit the English translation duly verified by the applicant/ person duly authorised by him that the contents thereof are correct and complete as per the requirement u/r 20(3) (b) of The Patents Rules The English Translation of the priority documents duly verified by the applicant (or person duly authorised by him) shall also be filed within 3 months as per the requirement u/r 21(2) and (3) of The Patent Rules PART-IV: DOCUMENTS ON RECORD Page 7 of 8

8 The examination report has been prepared based on the following documents: Request For Examination WITH REFERENCE NUMBER 5584/RQ-DEL/2012 FILLED ON 27 Jun 2012 FORM-6 WITH REFERENCE NUMBER E-8(i)/749/2014/DEL FILLED ON 07 Jul 2014 Name of the Controller: MANOJ MADHAVAN te: Last date for filing response to the Examination Report: 17/09/2017 Page 8 of 8