The Patents Act,1970 As amended by Patents (Amendment) Act,2005

In the matter of the Patent application No. 695/KOL/2007 and In the matter of a pregrant representation filed by Tulip Diagnostics(P) LTD,of Alto Santacruz, Bambolin Complex Post Office ,Goa 403202 under section 25(1)of the said Act and rule 55 thereof.

TULIP DIAGNOSTICS……………..Opponent versus LALIT MAHAJAN…………………… Applicant for Patent

Hearing held before Dr. D.K.Chakrabarti,Deputy Controller of Patents & Designs .

Present in the hearing : 1. Shri Subhasish Ghosh ,of Seenergi IPR, Kolkata,……on behalf of the Applicant 2. Shri R. Sharma

…………………… Representative of the Applicant

3. Shri A.Tewari, of K& S Partners…… on behalf of the Opponent 4. Shri Gautam Bhattacharya of K & S Partners … on behalf of the Opponent 5. Dr. S.K.Samantaray ……………………..Examiner of Patents & Designs

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An Application for Patent bearing no. 695/KOL/2007 was filed by MAHAJAN LALIT ,herein after called as “Applicant”of I-D, Manhar Mahal, 4, Bakul Bagan Roa,Behind Lansdowne Mkt.,Kolkata – 700025 on 07/05/2007 as an ordinary application titled “A Process for preparation of the partial thromboplastin time reagent and a device thereof” through their agent M.P.Bhatnagar of 161,Vigyan Vihar, New Delhi-110092.The said application was examined duly and First Examination report hereafter called as FER has been issued on 28.02.2008 . The response of FER was filed by the applicant on 28.08.2008 with a paragraph wise reply along with an amended set of claims as given in the following : 1.A process for preparation of Activated Partial Thromboplastin time reagent consists of the following steps: a.

Take 1-10 gm of the Rabbit Brain Acetone Powder and dissolving in 1 liter of Chloroform. b. Shake and stir well for 1-2 hr at room temperature. c. Filter the extract solution through Whatman No. 1 filter paper. d. Dry the above extract with inert Nitrogen gas. e. After drying process, obtain cephaloplastin pellet. Its concentration should be maintained between 10-100 mg/dl in final APTT reagent. f. Cephaloplastin pellet is dissolved in required amount of 0.01 to 1.0M Sodium Hydroxide Solution. g. Add Phenol in the concentration of 0.01 to 0.1Mole/litre. h. Add Ellagic Acid in the concentration of 0.025 to 0.045 gm/litre i. Add HEPES buffer in concentration of 0.6 to 4.6 gm/litre. j. Continuously stirring at 200 to 500rpm for 4 hrs. k. Adjust the pH of the solution with 1M HCI and set the final pH to 7.2+_0.1. l. Add the triple distilled water to adjust the final volume of the reagent. m. Add Transition Metal ions salt preferred, Nickel Chloride in concentration of 10-50 mg/litre. n. Stir for 2 hrs at 200-500 rpm. 2. A claim as in claim 1 wherein dissolving the Rabbit Brain Acetone Powder in 1- 10 gm of Chloroform. 3. A claim as in claim 1 wherein shake well and stir and filter the solution. 4. A claim as in claim 1 wherein dry the extract with inert nitrogen gas. 5. A claim as in claim 1 wherein the cephaloplastin pellet obtained in claim 4 is dissolved ill 0.01 to 1 M Sodium Hydroxide solution. 6. A claim as in claim' wherein add Phenol of concentration 0.01 to 0.1 Mole / litre to the mixture obtained in claim 5. 7. A claim as in claim I where in add Ellagic acid in the concentration of 0.025 to 0.045gr l/litre. 8. A claim as in claim I where in add HEPES buffer in concentration of 0.6 to 4.6gm/litre to the extract obtained in claim 7. 9. A claim as in claim 1 where in adjust the pH of the solution with 1M 2

HCI and set the final pH to 7.2+ _ 0.1. 10..A claim as in claim 1 where in add the triple distilled water to adjust the final volume of the reagent and then add transition metal ions salt preferred, Nickel Chloride in concentration of 10- 50 mg/litre and stir for hrs. 11.A process of preparation of the Activated Partial Thomboplastin Time Reagent as here in before described with reference to the examples. The Title of the invention also amended during the reply of FER as “A Process for preparation of the partial thromboplastin time reagent” A pregrant opposition was filed on 15.12.2008 by Tulip Diagnostic (P) Ltd , herein after called as “Opponent “through Rajeswari H , of K & S Partners in a statement taking the grounds 25 (1) (a) to 25 (1) (h).The following documents were also enclosed with the statement : 1. Annexure A US Patent No. 5055412 2. Annexure B : Non patent literature of Teco Diagnostics 3. Annexure C : Non Patent literature of Helena Laboratories 4. Annexure D : US Patent Document US 6391609 5. Annexure E : US published application US 2004/0086953 A1 6. Annexure F US Patent Document US6100072 7. Annexure G : US Patent Document US 6528273 B2 A notice regarding the said representation was sent to the applicant on 17.02.2009 with a copy to opponent . In response the Applicant filed the reply statement on 12.05.2009 through K. Jayasree, the present address for service holder of the applicant, with a paragraph wise reply. An evidence in support of the reply was also filed by Shri Lalit Mahajan, the applicant of the instant patent application.. A hearing was fixed on 01/12/2010 to dispose the representation under section 25 ( 1) and subsequently adjourned finally to 12/09/2012 to consider the several requests from both the sides for different dates for attending hearing. At the hearing for the Applicant Shri Subhashis Ghosh , learned counsel and Shri R. Sharma representative from the Applicant were present and from the opponent side Shri A. Tewari & Shri Gautam Bhattacharya learned counsels were present.After the conclusion of the hearing both the sides have been directed to file written note of arguments and subsequently both the parties have submitted the same. The applicant submitted some amendment proposal with the written note of arguments filed after the hearing. The amendment is mainly restricted to the specification pages wherein it has been observed that some duplication of the subject matter has been deleted and also number of claims reduced to 2 wherein there is an amendment of claim 1 in respect of language but no subject matter has been changed.

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Now I have turned my eyes to the statement of case of the Opponent and found that they relied on the following grounds : (i) Wrongful obtaining : - No evidence submitted (ii) Lack of Novelty wherein they have annexed the Patent document US 5055412 (iii) Prior Public use :- Annexed Annexure B & C i,e two documents of Teco diagnostics and Helena Laboratories respectively. (iv) Lack of inventive Step :- Relied on Annexure A –G as mentioned in the previous page. (v) Invention not patentable--- relied on grounds 2(i)(j),3(i),3(f) & 3(d) of the Act (vi) Not definitiveness of the invention (vii) Failure to provide information under section 8 of the Act. In the reply statement the Applicant mainly stressed on the point that documents cited by the opponent did not disclose the protocol of the preparation of the “Activated partial thromboplastin time reagent”. The applicant tried to prove that the novelty of the invention lies on the protocol of the preparation of the reagent.Further the evidence given by Shri Lalit Mahajan is almost same that of the reply statement. The opponent’s agent at the hearing submitted that the amendment done on the claim in the reply statement broadens the scope of the invention and accordingly they have submiited a comparative chart regarding that which are as follows : Original Claim 1

Amended Claim 1

of 695/KOL/2007

of 695/KOL/2007

A process for preparation of the activated partial thromboplastin time reagent comprising the following steps:

A process for preparation of Activated Partial Thromboplastin time reagent consists of the following steps:

Remarks

a) In amended claims amount of Rabbit Brain Acetone Powder has been increased to 1-10 gm in place of a)Take 1-10 gm of the Rabbit originally 1 gm. a) taking 1 gm of rabbit brain Brain Acetone Powder and Therefore, broadening acetone powder and dissolving in 1 liter of the scope of main claim dissolving in 500 ml of Chloroform. 1 at first step itself. chloroform. b)Shake and stir well for 1-2 hr b) shaking and stirring for 1 at room temperature. b) In original Claim 1, hr at room temp. c)Filter the extract solution step (b) is shaking and c) filtering through whatman through Whatman No. 1 filter stirring for 1 hr but in amended claim 1, step no. 1 filter paper the above paper. (b) it is stirring for 1-2 extract and drying it with hr. It is broad and not d)Dry the above extract with nitrogen gas. supported in inert Nitrogen gas. description. d) dissolving the extract in e)After drying process, obtain 0.9% NaCl solution (1litr). cephaloplastin pellet. Its concentration should be c) Step (d) of original 4

maintained between 10- claim 1 has been 100mg/dl in final APTT completely removed. In a step (d) extract is reagent. dissolved in 0.9% e) adding 4 gm of phenol. f)Cephaloplastin pellet is NaCl solution (1litr). dissolved in required amount However, there is no f) adding 0.3 gm of ellagic of 0.01 to 1.0M Sodium mention of NaCl in acid. Hydroxide Solution. amended claim 1. g) adding 2.6 gm of dry g)Add Phenol in the d) Amount of Phenol HEPES POWDER. concentration of 0.01 to has been changed from 0.1Mole/litre. h) adjusting the pH with 1M 4 gm to concentration HCl and the pH should be 0.01 – 0.1 h)Add Ellagic Acid in the of 7.2±1, thus obtaining the Mole/liter. concentration of 0.025 to reagent. 0.045mg/litre e) Amount of Ellagic i)Add HEPES buffer in Acid has been concentration of 0.6 to increased from 0.035 gm of original claim 1 4.6mg/litre. to 0.025 to 0.045 j)Continuously stirring at 200 gm/liter. Hence, broadening the scope to 500 rpm for 4 hrs. and new matter. k) Adjust the pH of the f) Adding new steps solution with 1M HCI and set (step l to n) in the final pH to 7.2+_0.1. amended claim 1. Transition l)Add the triple distilled Adding Metal ions salt water to adjust the final preferred, Nickel volume of the reagent. Chloride in m)Add Transition Metal ions concentration of 10-50 salt preferred, Nickel mg/litre, which was not Chloride in concentration of mentioned in original 10-50 mg/litre. claim 1 and introduces new subject matter n)Stir for 2 hrs at 200-500 which was not there in rpm. originally filed main claim 1. It also shows that step l to step n of amended claim 1 is the optional or conventional steps of prior art. In reply the applicant’s agent submitted that they have enclosed Annexure III which includes pages 8 and 13 of the complete specification with heading ‘as originally filed’ 5

and page 13 of the specification with the heading ‘as now on record’.The applicant’s agent submitted that full support for the revised claim 1 on record exists on page 8 which has been highlighted for convenience and also all other claims as amended are also supported by this portion. The applicant stated that while responding to the first examination report, the applicants can amend its claims based on original disclosure in accordance with Section 15 of the Act for the sake of correction and explanation and furthermore, Section 57 allows an applicant to make amendments in its specification provided it is within the provisions of Section 59.It was also submitted by the applicant’s agent that the highlighted portion on page 8 in Annexure III reveals that full support exists for existing claim 1 and the other claims as now on record. The applicant agent submitted that on comparison of the claim 1 on record(highlighted on page 13 as now on record of Annexure III), with the original claim 1(highlighted on page 13 as originally filed of Annexure III ) it would be amply clear that claim 1 on record has additional steps and is certainly narrowed down as compared to original claim 1. Based on the both sides submissions I have turned my eyes to the specification and I have observed that the amendments made by the applicant during the reply of FER, a Form 13 has been filed and the amendment done under section 57 are well within the scope of the invention and supported by the examples given in the specification. And I therefore dismiss the allegation of the opponent regarding the broadening of the claims. The agent of the Opponent alleged in the hearing as well as in the written note of arguments filed after the hearing that the instant application for the Patent has been filed in the wrong jurisdiction. In this respect the Opponent had also submitted the list of cases Patent applications and Granted Patents) filed by Mr. Lalit Mahajan in both Delhi and Kolkata (Enclosed herewith as Exhibit B of the written note of the opponent). It was submitted by the Opponent that out of total 36 pending Patent Applications, 31 are filed in Delhi and only 5 are filed in Kolkata. Similarly, there are total 35 granted cases, of which 27 were filed in Delhi and 8 were filed in Kolkata. It was also pointed out by the Opponent that most of the cases of Mr. Lalit Mahajan are currently into Oppositions and revocations proceedings. For example, there are 22 pre grant opposition in total 36 cases and 21 (Post-grant and revocation) out of 35 granted cases of Mr. Lalit Mahajan. It was strongly argued by the Opponent that “Mr. Lalit Mahjan has filed more than 90% of his cases in Delhi being a Managing Director of his Company, J. MITRA, which is based in Okhla, Delhi.The It is to be also noted that Applicant has stated in their reply statement, their address as J. Mitra & Co. Pvt. Ltd., A-180, Okhla Industrial Area, Phase-I, New Delhi 110020, India, where as the application was filed in Kolkata. Accordingly, the Application should be treated as void in that it was filed in wrong jurisdiction. The Applicant has intentionally tried to misappropriate the jurisdiction and filed his cases in wrong Jurisdiction to avoid series of opposition filed against him in Delhi. Thus, this act of Applicant also implies to wrongful obtaining of the Patent from the Indian Patent office. Accordingly, on this ground alone, this patent application is liable to be rejected.” In reply of the foregoing issue the agent of the Applicant submitted at the hearing and also in the written note of arguments that “ during the course of the hearing the Learned Opponents’ agent had raised the issue that the instant application is not filed at the appropriate jurisdiction. In the concluding part of Section 25 (1) of the Act it has been clarified that patent applications can be opposed only under grounds as provided 6

under 25 (1) but on no other ground and hence this ground taken up by the opponent ought to be dismissed, as it does not come within the ambit of Section 25(1) of the Act.” The applicant’s agent also submitted that without prejudice to the contention as submitted above that under Rule 4(i) of the prevailing Indian Patents Rules one of the criteria for determining jurisdiction of a patent application is, “the address where the applicant has a place of business”. It was also submitted by the Applicant the during the last five years, Mr. Mahajan has a place of business in Kolkata and hence he is entitled to file applications in Kolkata, even if it is inconvenient for the opponents to depute his representatives for opposing Mr. Mahajans’ applications. I have observed both sides observations in respect of the jurisdiction issue and turned my eyes to the relevant section 25(1) of the Patents Act and found that no ground is available for the jurisdiction and also rule 4(1) (i)(a) of the Patents Rule states that Applicant’s place of buissness can determine the jurisdiction. As the Applicant herein has a place of business at Kolkata and also there is no ground available under section 25(i) of the Act, the opponent’s allegation regarding wrong jurisdiction is dismissed and I like to proceed further for the other issues. On consideration the statement of case, reply statement,evidences from both sides , oral hearing and written note of arguments I consider to resolve other issues which are recited below : 1. Whether the invention of the instant Patent Application attracts “Wrongful obtaining”? 2. Whether the invention of the instant Patent Application lacks “Novelty”? 3. Whether the invention of the instant Patent Application lacks “Inventive step”? 4. Whether the invention of the instant Patent Application attracts “Prior public use” 5. Whether the invention of the instant Patent Application does not sufficiently describe in the specification ? To decide the first issue as above i.e “Wrongful Obtaining” I have turned my eyes to the statement of case of the opponent and found no evidences have been filed during the filing of the representation but afterwards the opponent has filed additional evidence in this regard on February 19, 2009 immediately after filing of representation. The Opponent submitted in the written note of arguments that Applicants have not given any kind of reply to the Opponent product “Liquicelin-E” in their whole Reply Statement dated May 11, 2009.The opponent in the written note submitted that during the oral arguments that opponent showed that they got the permission to manufacture product Liquicelin-E (Rabbit brain cephaloplastin with elagic acid) on 29 January, 1999 and thereafter renewed it from time to time. The opponent’s agent also submitted that they have attached with the written note the product broucher, manufacturing license and sale invoices in respect of Liquicelin-E (Exhibit A of the written note of arguments of the opponent). The Opponent had shown few more catalogues of similar product available on their website.The opponent submitted the list of cases for Patent applications and Granted Patents) filed by Mr. Lalit Mahajan in both Delhi and Kolkata (Enclosed herewith as Exhibit B of the written note of arguments of the opponent) alongwith the written note of arguments. 7

The applicant’s agent denied the allegation of wrongful obtaining of the opponent in the reply statement.The Applicant’s agent in the written note of arguments after the hearing in support of the ground as provided under Section 25 (1)(a) of the Act submitted that “ the opponent has not submitted any evidence nor has the ground been explicitly pleaded by the Learned Opponents’ agent during the course of the hearing. The provision under Rule 55 (1) of the prevalent Patent Rules, clearly states that the representation by way of opposition must include a statement and an evidence, if any. As no evidence has been provided, so in our humble submission it ought to be interpreted that there is no evidence and it is respectfully requested that no further evidence be allowed to be submitted as that would tantamount to gross violation of the provision under Rule 55(1) of the prevalent Patents Rules.” The applicant’s agent requested that this ground be dismissed. I have traversed the arguments of both the parties and gone through the product details of Liquicelin-E as produced by the opponent as annexure in the written note and found that it is a sales permission, manufacturing license and sales invoices of the Activated Partial Thromboplastin time reagent but nothing has been given regarding the process for preparation of the said reagent. I therefore opine that the said document can not be considered as an evidence for the ground of wrongful obtaining. I therefore dismiss the issue no1.as mentioned above. Regarding the issue no. 2 that whether the invention of the instant Patent Application lacks “Novelty” I have turned my eyes to the opponents statement of case and found that the Applicant mainly relied on “US 5055412” and “Teco Diagnostic –a non patent literature” while arguing for the novelty on the basis of the claims filed in the original specification but not on the amendment done during the reply of the FER . But during the time of oral submission and in the written note of arguments, the submissions were based on the amended set of claims which is already reproduced in page 2 of this decision. I will hereafter concentrate with the amended set of claims for determining different issues of the instant pregrant opposition. The Opponent agent in the hearing mainly relied on US 5055412 ,hereinafter called as US,412 and submitted the following : The agent of the Opponent argued that claim 1 and other claims of the impugned application are fully disclosed and anticipated by US ‘412, in respect of amount and proportions of main reagents. The opponent’s agent submitted that US Patent No: 5,055,412 involves a partial thromboplastin time test reagent which is factor sensitive depending upon the selected reagent constituents and the method for preparing such reagent is also disclosed. The opponent’s agent submitted that the reagents contain ellagic acid or an ellagic acid salt and divalent metal ions in a specific molar ratio relative to the ellagic acid or ellagic acid salt and for the statement the agent referred Column 1, lines 54 to 68 of US ‘412. The agent of the opponent then mentioned Column 3, lines 52 to 60 of US ‘412 reads as:“A further embodiment of the present invention is a method for making the above factor sensitive reagent for measuring partial thromboplastin time which requires the sequential steps of preparing a basic ellagic acid solution, adding an appropriate quantity of cephalin to the solution, followed by addition of a divalent metal ion in the appropriate molar ratio after an interval of time.” The opponent agent also 8

added that “Column 6, lines 34-41 of US ‘412 mentions that “ phenol may be used as a preservative and to inhibit bacterial growth in the reagent,other common preservative may also be used. HEPES hemisodium salt is an effective buffering material for maintaining the desired pH, typically about 7.4. Other buffers, readily known to those of the ordinary skilled in the art, may also be used.” The opponent’s agent submitted again that in Column 6, lines 51-68 of US ‘412 read as: “A further embodiment of the present invention involves a method for making the factor sensitive APTT reagent described above. In making the factor sensitive APTT reagent it is important that the components be added in a specific order and, between some additions, sufficient time elapse for the solutes to react …………..” The opponent’s agent in the hearing as well as in the written note of arguments submitted “The whole Example 1 disclose the process for preparation of the activated partial thromboplastin reagent as disclosed in claim 1 of the impugned application. It was argued that Steps 1 to 4 of Example 1 relates to preparation of ellagic acid solution, Steps 5 to 7 relates to preparation of Cephalin from rabbit brain and whereas in step 8, the resulting cephalin mixture (of steps 5 to 7) is strained through glass wool into the ellagic acid solution (of step 1 to 4) with stirring. Thereafter, interval of 30 minutes, divalent metal is added in step 9.” The opponents agent then submitted that thus Example 1 of US 5,055,412 fully teaches that (i) Cephalin mixture should be added to (ii) ellagic acid solution, and (iii) after an interval (30 minutes), divalent metal should be added in order to prepare APTT reagent of exceptional stability.The Opponent’s agent then referred to the Granted Claims, particularly Claims 37 and 38 of US ‘412 and submitted that the said claims also disclose the impugned process as claimed by new amended claim 1. The opponent’s agent submits that in Claim 38, cephalin is mentioned prior to ellagic acid. and the divalent metal ion is added in the last,thus all the steps of preparation of the activated partial thromboplastin reagent as claimed in the original or amended claim 1 and other claims of the impugned application are disclosed in US ‘412.” The opponent agent then showed a comparative table of the instant application and the Prior art. The opponent agent also submitted that “Upon experimentation, applicant surprisingly discovered that any modifications of the sequence dramatically affect the stability of the present invention. For example, should the metal ion be added to the ellagic acid solution before the addition of the cephalin, rather than as the last step of the procedure, the ellagic acid:cephalin:metal ion complex does not become optimally active. Thus it is crucial in practicing the present invention with the heretofore unknown high metal ion concentrations that the reagent components be added in the order described above.The above paragraph of US ‘412 clearly teaches that metal ion should be added in the last. Column 4, last Para and Column 5, lines 1-25 of US ‘412 clearly describe the importance of metal ion in relation to ellagic acid. ………………………………..At this concentration enough metal ions are present to form bridges between ellagic acid molecules and cephalin, but without causing precipitation. If the metal ion concentration is too low there are insufficient metal ions to coordinate with the ellagic acid present resulting in poor coagulation activation at neutral or alkaline pH. If no metal ions are present in solution, ellagic acid is completely ineffective as a prothrombin activator. Interestingly, if the metal ion concentration becomes too high the ellagic acid:cephalin:metal ion complex precipitates and no ellagic acid is left in solution to 9

activate thromboplastin formation……………………..”. The opponent’s agent submitted that the metal ion should only be added in the last to prepare stable ellagic acid:cephalin: metal ion complex and without causing any precipitate. The opponent’s agent submitted that in addition, the attention is also drawn to the periodic table showing position of divalent metal disclosed in US ‘412 and Nickel. It was argued that it is very much clear to the person skilled in the art from the periodic table (which is common general knowledge) that Nickel can be used as alternate substitute for other divalent transitional metal such as Mn, Fe, Co, Cu, Zn etc. It was argued that US ‘412 covers divalent metal No. 25, 26, 27, 29, 30 of the periodic table. The Nickel which is divalent transitional metal No. 28 can be used as alternate substitute in the process of preparing APTT reagent. ( Copy of periodic table is enclosed herewith as Exhibit “C” of the written note of arguments of the opponent. ) The opponent then submits “that the process for preparation of activated partial thrompboplastin time reagent, as claimed in original claims or even in new amended claim 1 and other claims of the impugned application are fully disclosed in US ‘412 along with amount, ranges and ratios of each ellagic acid, cephalin and metal ion. US ‘412 should be taken to be providing a clear and unmistakable direction, as is required by the established jurisprudence on novelty or as it is customary practice in determining novelty, to the Applicant or to any skilled artisan, to reach to the claimed process of preparing APTT.” The opponent stated that “from the discussion above , it is clear that the claims of the impugned application 695/KOL/2007 lack novelty in view of US ‘412. Thus as illustrated above, each and every element of the process for preparation of the activated partial thromboplastin time reagent as claimed in the impugned application has been fully and completely disclosed by US ‘412 and all the claims of the impugned application are liable to be rejected on the ground of lack of novelty alone.” The only case law cited by the opponent for the argument against novelty is the decision w.r.t 692/KOL/2007 and I observe that the said case law is pertinent to dispose the instant case. The agent of the Applicant while replying the ground of novelty submitted that in connection with the ground under Section 25(1)(b) of the Act the opponent has relied upon Annexure A (US Patent No, 5055412) and Annexure B (being Teco Diagnostics , Hem-10207 which appears to be an instruction manual) in its written statement of opposition. The Applicant’s agent referred to Example I in column 7 of Annexure A following the usual method of understanding an invention from a complete specification and this has been further endorsed in lines 15 to 20 of column 7 of Annexure A. The Applicant’s agent also submitted that Example 2 in column 8 of Annexure A is same as Example 1 except that magnesium chloride is added in step vii) instead of manganese chloride and examples 3 to 6 in column 8 of Annexure A is not relevant for the instant application as it relates to Preparation of Platelet Factor Reagent. The applicant’s agent stated that for Example 7 in column 8 of Annexure A relates to Determination Activated Patial Thromboplastin Time using an Optical Instrument and compared the explicit steps in Example 1 and Example 2 of Annexure A with the steps in claim 1 of the instant application and submitted that the sequence of steps f) to n) in claim 1 are grossly different , from the steps i) to viii) in example 1 of Annexure A when taken together. The applicant’s agent submitted that the lines 56 to 68 of column 6 of Annexure A specifically discloses a general description of the sequence of addition of components which also 10

clarifies that the details exist in the Examples. The applicant’s agent again submitted that such broad sequence described in Annexure A is also different from the sequence of steps defined in claim 1. The sequence in claim 1, comprises adding cephaloplastin pellets to sodium hydroxide solution, then phenol is added to it, thereafter ellagic acid is added, then HEPES buffer is added, continuous stirring is done for 4hours, the PH of the solution is adjusted and the final PH is set to approximately 7.2, triple distilled water is added to adjust the final volume of the reagent and finally transition metal ion salts preferably as nickel chloride is added and the resultant product is stirred for 2 hrs. as stated by the Applicant. The Applicant’s agent then submitted that the order in which the components are added in the instant application are entirely different from the order in which the components are added in the invention of Annexure A and thus can not be considered to anticipate the instant invention and the various portions referred to in Annexure A by the opponents in its written statement of opposition and by the learned agent of the opponent in the hearing are all irrelevant and misleading. The Applicant’s agent then submitted that “the learned opponents’ agent has provided a copy of a periodic table during the course of the hearing indicating that the divalent ion in the invention of Annexure A may be nickel as well. Without prejudice to our submissions that the entire sequence of steps in claim 1 on record is new, your good self is requested to refer to lines 59 to 68 of column 5 of Annexure A which states that all divalent metal ions are not applicable in the invention of Annexure A. Having regard to our above submissions and to the established proposition of law on patents, it is respectfully requested that the ground taken up under Section 25(1)(b) be dismissed as such ground is not substantiated by relevant documentary evidence or other evidence.During the course of the hearing the Learned Opponents’ agent submitted a few documents further document regarding the product Liquiceline-E of the opponent marked as (1) having a cover page with the title “National Library of Medicine-Medical Subject Headings” . This document was forwarded neither to the applicant nor to the patent office and it is respectfully requested that this document may not be taken on record at this stage and also this document is an irrelevant document as explained in the following paragraph. This is also true for the US patent 5451509 cited during the hearing. In our humble submission presenting fresh documents during the hearing is unethical and unlawful and hence should not be allowed to be taken on record.Without prejudice to our contention in the preceding paragraph and on protest it is respectfully submitted that the documents as particularized in the preceding paragraph do not teach the sequence of steps as defined in claim 1 on record and as such are irrelevant. Having regard to our above submissions and to the established proposition of law on patents, it is respectfully requested that the ground taken up under Section 25(1)(b) be dismissed as such ground is not substantiated by relevant documentary evidence or other evidence.” The different case laws cited by the Applicant in favour of their argument on novelty is following : 1. Lallubhai Chakabhai vs Chimanlal Chunilal & Co., Mumbai High Court, 3rd April 1935(page 15, Narayanan 3rd addition adduced herewith as Annexure IV) 2. Flour oxidizing Vs Carr 1908 25 RPC 428 AT 457 Parker J(page 313, Narayanan 3rd Edition- Annexure V) 11

3. Farbwerke Hoechst AG V Unichem Laboratories(1969) RPC 55(Bombay HC), AIR 1958 Bom 255 at 256( page 312, Narayanan 3rd edition-Annexure VI 4. Daikin Kogyo Co. Ltd’s Application(1974)RPC 559 at 580(CA) (page 165 Narayanan-third edition –Annexure VII) Before going into details to decide the issue I think I should look the corresponding provisions of the Act.i.e 25(1)(b) & 13 which are recited below. (b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim— (i) in any specification filed in pursuance of an application for a patent made in India on or after the 1 st day of January, 1912; or (ii) in India or elsewhere, in any other document: Provided that the ground specified in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of section 29; Section 13 Search for anticipation by previous publication and by prior claim. (1) The examiner to whom an application for a patent is referred under section 12 shall make investigation for the purpose of ascertaining whether the invention so far as claimed in any claim of the complete specification— (a) has been anticipated by publication before the date of filing of the applicant's complete specification in any specification filed in pursuance of an application for a patent made in India and dated on or after the 1st day of January, 1912; I have traversed then the statement of case with evidence and the submission in the hearing and the written note of arguments of the opponent and observed that the opponent mainly relied on the document US 5,055,412 for the abovementioned issue and argued that the claims of the instant Patent application were completely anticipated by the US document. I have then considered the US document and found that the same was granted on 08/11/1991 and therefore I can consider it as a prior published document and then I have compared the instant application with the US document and observed that the ingredient used for both processes are same viz. Rabit brain acetone powder extract, phenol, Ellagic acid,Divalent metal ion and HEPES buffer.In the US specification I have observed that at page 7 of the said specification it has been stated that any modification in the sequence of step dramatically affect the stability of the present invention. The applicant also submitted in the written note after the hearing, as well as in the hearing or in the reply statement that the sequence of the process steps of the instant invention increases the stability of the product i.e Activated Partial Thromboplastin time reagent. But surprisingly I have 12

observed that the applicant never stated the fact of greater stability of the product in the specification during filing of the patent application or in the amended stage when the reply of the FER was filed. I have also observed that the applicant has referred this US patent document in the specification as one of the prior arts but never stated in the specification, the problem of this prior art and the solution made thereof so that an effective product was obtained over the prior art of the US document. The applicant in the reply statement only submitted that the protocol used in the instant invention for the preparation increases the stability of the product. I have then traversed the document cited by the opponent viz. US 5055412 and observed the following : “The said document in the column 7 from line 5 onwards stated that upon experimentation applicant surprisingly found that any modification of the sequence dramatically affect the stability of the present invention. For Example should the metal ion be added to the ellagic acid solution before the addition of the cephalin , rather than as the last step of the procedure , the ellagic acid : cephalin : metal ion complex does not optimally active.” From the abovementioned statement I understand that the sequence of the preparation mainly depends on the addition of metal ion after the addition of the cephalin or cephaloplastin to get an effective product. Also I have observed that in US specification in column 5 line 13 which stated that “the applicant has found that the preferred ratio of divalent metal ions to ellagic acid is approximately 4 molesof divalent metal ion to one mole of ellagic acid.for example, if ellagic acid concentration is 0.1 mM then the divalent ion concentration should be between 0.7 mM and 0.3 mM , preferably approximately 0.4 mm.” Also I have found in the US specification at column 5 from line 35 onwards that “The applicant has discovered that when the Ellagic acid concentration is approximately 0.1 mM, cephalin should be present at approximately 1 mg/ml.”.Regarding other ingredients used for the preparation of the APTT reagent I have seen the US document wherein it has been stated that in column 6 from line 34 onwards that “Phenol may be used as a preservative” and “HEPES hemisodium salt is an effective buffering material used for the maintainance of desired pH.” From the abovementioned discussion it is clear to me that the effective process for the preparation of APTT reagent solely depends on the cephalin,Ellagic acid and metal ion concentrations and the protocol is metal ion should be added in the last step. Now I will turn my eyes to the principal claim of the instant Patent Application and observed that the concentration of the different components used for the preparation of the APPT reagent viz cephaloplastin 10-100 mg /dl, phenol 0.01 – 01 mole / litre, elagic acid 0.025-0.045 cm/litre, HEPES buffer 0.6 – 4.6 gm / litre are mixed in an environment of pH. 7.2+_0.1. and divalent metal chloride 10-50 mg/ litre. When the same is compared with the whole of the US document I have observed the following : Indian Patent Application 695/KOL/2007 US 5,055,412 Cephaloplastin/Cephalin(Source: Rabbit Brain Cephaloplastin/Cephalin (Source: Rabbit Acetone powder) Concentration: Brains) ( column 5, line 40) 10-100 mg/dl (Claim 1) or Concentration :1 mg/ml or 100mg/dl 0.1 – 1 mg/ml (Column 5, lines 38-39) 13

Ellagic acid Concentration: 0.025 to 0.045 gm/l Ellagic acid Concentration : 0.1 mM or (claim 1) or 0.08 mM to 0.14 mM 0.0302 g/l, (Average wt of Ellagic acid:

302.192)[ Column 5, lines 16-18 and 37-40; Claims 41, 50 and also Claims 8, 16, 32] Divalent Metal ion Concentration: 10-50 mg/l Divalent Metal ion Concentration : 0.05 (claim 1) or 0.05 mM – 0.3 mM mM-0.3mM (column 5, lines 16-18; Column 6, lines 11-16; ) The metal ion is added at the last in the The metal ion is added at the last in the process step(claim 1) process step Cephalin: Ellagic acid -- 0.1: 0.045 to 1: .025 or Cephalin is 2.22 to 40 times of Ellagic acid(claim 1) Ratio of Ellagic acid to metal ion ---0.08: 0.3 to 0.14: 0.05 i.e Ellagic acid is 0.26 to 2.8 times the metal ion(claim 1 )

Cephalin: Ellagic acid --1: 0.0302 i.e Cephalin is 33.11 times of Ellagic acid

Ratio of Ellagic acid to metal ion ---0.1: 0.3 to 0.1: 0.05 i.e Ellagic acid is 0.33 to 2 times the metal ion

Regarding the use of Nickel as divalent metal ion, the opponent’s agent, in the statement of case, as well as in the hearing or written note of arguments, submitted that the periodic table (enclosed in the written note as Exhibit C) showing position of different divalent metals disclosed in US ‘412 along with Nickel which has been used in the instant process claim . It was argued that it is very much clear to the person skilled in the art from the periodic table (which is common general knowledge) that Nickel can be used as alternate substitute for other divalent transitional metal such as Mn, Fe, Co, Cu, Zn etc. It was argued that US ‘412 covers divalent metal No. 25, 26, 27, 29, 30 of the periodic table. The Nickel which is divalent transitional metal No. 28 can be used as alternate substitute in the process of preparing APTT reagent. Copy of periodic table is enclosed herewith as Exhibit “C”. In the reply statement and also in the hearing and written note of arguments the applicant submitted that using “Ni” in the entire sequence of steps in claim 1 on record is new. The agent referred that lines 59 to 68 of column 5 of Annexure A which states that all divalent metal ions are not applicable in the invention of Annexure A. Barium is ineffective as revealed by applicants’ studies and calcium tends to precipitate at required high concentration and it tends to detune the reagent. Further, the entire Annexure A does not give the slightest hint that nickel may be applied as a divalent metal ion in the invention of Annexure A. However, in certain portions of Annexure A hints regarding possible metal ions are provided. In the of issue of using metal ions I have gone through the arguments of the both sides and then I have gone through the claim 1 of the instant application and seen that in step (m) of the said claim 1 states that “Add Transition Metal ions salt preferred, Nickel Chloride in concentration of 1050 mg/litre Then I have traversed the US specification and found that out of the metals cobalt , manganese or iron also used for the purpose of addition of metal ions(Claim 5 of the US claims). As a general knowledge of chemistry I opine that Nickel can easily be an alternate substitute in replace of the abovementioned metal ions. Hence I can not say that novelty can be established by using Nickel in stead of the other transitional metal ions used in the cited US specification.

From the abovementioned comparison of the claim 1 of the instant application with the whole specification of US,412 and also the discussions in details above it is amply clear that the ratio and proportions of different ingredients used in the process as well as sequence are almost same and therefore the process of the instant application 14

695/KOL/2007 is anticipated by the prior published document US 5055412.In this connection I also like to mention that after the hearing the Applicant has made some amendments in the set of claims and also in the pages of the specification . It is also to mention that the applicant’s agent only mention in the hearing that some amendments will be made for the better clarity of the invention but the agent has not served any copy to the other party or to the undersigned during the hearing.However the amendments made in the claim after the hearing in the written note of arguments are as following : 1. A process of preparation of Activated Partial Thromboplastin time reagent consists of the following steps:a. Taking 1-10 gm of the Rabbit Brain Acetone Powder and dissolving in 1 liter of Chloroform. b.

Shaking and stirring well for 1-2 hr at room temperature.

c.

Filtering the extract solution through Whatman No.1 filter paper.

d.

Drying the above extract with inert Nitrogen gas.

e. After drying process, obtaining cephaloptastin pellet such that its concentration is maintained between 10- 100mg/dl in final APTT reagent. f. Cephaloplastin pellet is dissolved in required amount of 0.01 to 1.0M Sodium Hydroxide Solution. g.

Adding Phenol in the concentration of 0.01 to 0.1 Mole/litre.

h.

Adding Ellagic Acid in the concentration of 0.025 to 0.045gm/litre.

i.

Adding HEPES buffer in concentration of 0.6 to4.6grn/ litre,

j.

Continuously stirring at 200 to 500rpm for 4 hrs.

k.

Adjusting the pH of the solution with 1M HCI and set the final pH to 7.2±0.1.

l.

Adding the triple distilled water to adjust the final volume of the reagent,

m. Adding Transition Metal ion salt preferably Nickel Chloride in concentration of 10- 50 mg/ litre. n.

Stirring for 2 hrs at 200-500 rpm.

2. As process of preparation of the Activated Partial Thromboplastin Time Reagent as here in before described with reference to the examples. The applicant’s agent also made amendments in the pages are as following : “The present invention relates to a process of preparation of Activated Partial Thromboplastin Time (APTT) reagent which is used for the determination of Activated partial thromoboplastin time in whole blood or plasma sample at ambient temperature and 15

more specifically to a process of preparation of Activated Partial Thromboplastin Time (APTT) reagent which ensures that chances of precipitation of ellagic acid :cephalin:metal ion complex is substantially done away with.”[ Field of invention] “It is the principal object of the present invention to provide a process of preparation of Activated Partial Thromboplastin Time (APTT) reagent which ensures that chances of precipitation of ellagic acid :cephalin:metal ion complex is substantially done away with. It is another object of the present invention to provide a process of preparation of Activated Partial Thromboplastin Time (APTT) reagent which is straight forward and comparatively faster than prior art acknowledged.”[Object of invention]. I have observed that by the amendments of claims the scope of the invention has not been changed. But while traversing the amendments in the field of invention or object of the invention I have observed that The applicant has included a distinction of the invention w.r.t the greater stability of the product i.e chances of precipitation of ellagic acid :cephalin:metal ion complex is substantially done away with. I consider that after the hearing the applicant has proposed the abovementioned amendments with an attempt to obviate the arguments of the opponent. Notwithstanding that, by the said proposed amendments the applicant tried to bring in more clarity in the specification. However, the clarity with respect to the problem and solution as described in the specification, the proposed amendments does not alter the scope of the alleged invention and fails to rescue it from the attack of the lacking of novelty. I opine that there was no such reference of the surprising stability for the applicant’s product anywhere in the specification as filed and as amended to FER. Moreover, it appears to me that this is a mere statement. The applicant never tried to corroborate this statement by way of any comparative data, the experimental details and/or other findings. I cannot accept this statement at this stage. Thus process for preparation of activated partial thromboplastin time reagent, as claimed in claims of the impugned application are fully disclosed in US ‘412 along with amount, ranges and ratios of each ellagic acid, cephalin and metal ion. US ‘412 should be taken to be providing a clear and unmistakable direction, as is required by the established jurisprudence on novelty or as it is customary practice in determining novelty, to the Applicant or to any skilled artisan, to reach to the claimed process of preparing APTT. I therefore opine that the claims of the instant invention lacks novelty with respect to the document US 5055412 and could not satisfy section 25(1) (b) of the Act.

Regarding issue no 3 i.e whether the invention of the instant Patent Application lacks inventive step or not I have turned my eyes to the opponent’s statement of case , oral hearing and written note of arguments and observed that the following documents have been cited : (a) US patent 5,055,412 granted on 8th October, 1991 (b) US patent 5,451,509 granted on 19 September, 1995 (Exhibit ‘D’) 16

(c) Liquicelin-E (Opponent’s own product since 1999 in India) (d) Teco Diagnostics, HEM-10207, published in January, 2007 (e) Catalog no. 5383, 5384, 5385, AND 5386 of Helena laboratories published on June, 1996 (f ) US Patent No. 6,391,609 granted on May 21st, 2002 (g) US Patent application No. 20040086953 filled on November 05, 2000 (h) US Patent No. 6,100,072 granted on August 08, 2000 (i) US Patent No. 6,528,273 granted on March 04th, 2003 The opponent’s agent also cited different case laws including the decision in respect of Patent Application 692/kol/2007,different decision of European board of Appeal and also IPAB to demonstrate and discuss the methodology of determining inventive steps of any invention. The applicant’s agent replied all the documents of the opponents categorically for taking the defence. The applicant’s agent also cited the following case laws to establish the instant application having inventive steps: (i)Lownde’s Patent( Revocation)(1928)45RPC 48 at 57 ( ii)Lallubhai Chakabhai vs Chimanlal Chunilal & Co., Mumbai High Court, 3rd April 1935(page 15, Narayanan 3rd addition adduced herewith as Annexure IV) ( iii) Von Heyden V Neustadt it has been laid down that “If the patentee has made his discovery by studying, collating and applying a number of facts discriminated in pages of mosaic of works, his diligent study of such works would as much entitle him to the character of an inventor as the diligent study of the works of nature would do.”(Pages 316 and 317 Narayanan, 3rd Edition-Annexure X). ( iv)Lallubhai Chakubhai Jariwala Vs Shamaldas Sankalchand Shah AIR 1934 Bom 407 at 413 it has been laid down that “ if the result produced by such a combination is either a new article or a better article or a cheaper article than before such combination is an invention or a manufacture within the statute”(Page 347 Narayanan-third editionAnnexure XII). Before going into details I like to see the section where the inventive step has been defined in the Act. Section 2 (ja) "inventive step" means a feature of an invention that involves technicaladvance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;' Section 25(1) (e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard 17

to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant's claim; Inventive step is normally to be decided when the invention passes the test of novelty . But still I have considered all the documents filed by both the parties during the different stages of the prosecution and I have found that the most relevant document is US’412 which has been discussed in details during the assessment of the novelty in the preceding paragraphs and I opine that as the invention does not pass the test of novelty , it also lacks inventive steps. Regarding issue no. 4 i.e. whether the invention of the instant Patent Application attracts “Prior public use” I have turned my eyes to the Opponent’s submission and found that the opponent’s submission is “ with regard to prior use, the activated thromboplastin reagent, process for preparing the same, and test device as originally claimed by the impugned application has been a subject of extensive prior use prior to the date of filing, i.e. prior to 07th May, 2007. The impugned application claims nothing new, but process for preparing the activated partial thromboplastin time (APTT) reagent for the analysis of clotting time. The Opponent submits that such a process and kits using this process have been known in the art and used for many years prior to the date of filing. For example there are documents disclosing the use of activated partial thromboplastin time reagent and process as claimed in the impugned application eg. Opponent’s own product Liquicelin-E is in Indian Market since 1999 and also being renewed from time to time. The copy of product Boucher, manufacturing license and sale invoices in respect of Liquicelin-E is enclosed herewith (Exhibit A). Further, such reagent and device were also made and used by Teco diagnostics, Anaheim, CA and Helen laboratories, Beaumont, Texas. The reagent and device were available in India and had been validated for the specificity and sensitivity of the method in detecting the prothrombin time test. Catalog no. 5383, 5384, 5385, and 5386 of Helena laboratories published on June, 1996 disclose activated partial thromboplastin reagent and its use.Commercially available activated partial thromboplastin reagent is manufactured by Teco diagnostics, and Helena Laboratories have been used extensively. The insert discloses that the reagent composition comprises a preparation of rabbit brain cephallin and ellagic acid activator with buffer, stabilizers and preservatives. Further, the headline specimen collection discloses the same matter as discloses under the specification of the impugned application.” In response the applicant submitted that none of the documents which has been cited by the opponent does not disclose the process for the preparation with a particular protocol. I have traversed the arguments of both the parties and gone through the product details of Liquicelin-E as produced by the opponent as annexure and also other documents like catalogs etc. found that these are sales permission, manufacturing license and sales invoices of the Activated Partial Thromboplastin time reagent but nothing has been given regarding the process for preparation of the said reagent.and therefore opine that as the instant invention concentrates on process claim it does not come under the “ prior public use” with respect to the documents cited by the opponent for this issue.. 18

Regarding issue no. 5 i.e whether the invention of the instant Patent Application does not sufficiently describe in the specification I have traversed all the documents filed by the both parties in the statement of case , evidence , oral hearing , followed by written note of arguments . After that I have gone through the specification and found that the specification is not satisfactory in respect to clarity . I have also observed that in the initial stage of application and also after the reply of FER the applicant has not described anything in the specification to overcome the problem over the closest prior art.But after the representation has been filed , in the reply statement the applicant submitted that the product obtained by the instant process is more stable than the process of the cited US document. Furthermore the applicant also proposed some amendments after the hearing i.e in the written note of arguments wherein a statement included in the object of invention (discussed in this decision earlier) that the process of the instant application restricts the precipitation of ellagic acid but no experimental data to corroborate this statement has been given by way of comparative data over the prior art. I therefore opine that the invention has not been described clearly and sufficiently in the specification. In view of my discussion in the preceding paragraphs and also considering the statement of case, reply statement , evidence and reply evidence, oral hearing and written note of arguments filed by both the parties, I opine that the invention of the instant Patent application number 695/KOL/2007 could not pass the test of novelty[25(1)(b)], inventive step[25(1)(e)] and also the invention could not be described clearly and sufficiently in the specification [25(1)(g)] and I therefore order to refuse the Patent Application No. 695/KOL/2007 without cost to any party. Dated the 20th May,2014 (Dr. D.K.Chakrabarti) Deputy Controller of Patents & Designs Patent Office, Kolkata

Copy to 1.

K.Jayasree,A-180,Okha Industrial Area,Phase 1, New Delhi-110020

2.

Shri D.C.Gabriel,of K&S Partners,B.K.House,PlotNo 109,Sector44,Gurgaon-122002

3.

Office File

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