How the Indian Patent Office Rejected Applications on Artificial Sweeteners

Artificial sweeteners are non-nutritive or low-calorie substitutes that can be used as alternatives to table sugar. An artificial sweetener is a food additive that duplicates the effect of sugar in taste but usually has fewer calories.¹ The most commonly known artificial sweeteners are Saccharin, Acesulfame K, Neotame, Advantame, Aspartame, Sucralose, Steviol glycosides etc.² The use of low-calorie sweeteners by diabetic and obese people is increasing at a high pace, but these are reported to have some side effects. In the past few years, the use of artificial sweeteners in food and drink products has expanded significantly. In India, a number of patent applications have been filed on sweeteners over the years. For this analysis, published applications on sweeteners have been searched on the Indian patent office site and refused applications were analysed. A comprehensive analysis of these applications provided the understanding of reasons for rejection. The independent claim, issues highlighted by the examiners in the first examination report, replies and amendments by the applicants, hearing and controller’s decision on the applications were analysed to have a better understanding of grounds of rejection.

ANALYSIS OF PATENT APPLICATIONS

1.  SWEETENER, METHODS OF PREPARING SWEETENER AND APPLICATIONS THEREOF

A patent application (7884/CHENP/2010) described a taste-modifying sweetener composition and method of making the same.³ The independent claim and other dependent claims were objected by the examiner in the first examination report (FER). The examiner highlighted issues related to the subject matter of some claims not constituting an invention under section 2(1)(j) of the Patents Act, 1970,⁴ in the light of prior published documents. Also, the independent claim did not involve inventive step u/s 2(1)(j) of the Patents Act, 1970 in view of the disclosures in the cited prior art. Besides, some claims were statutorily non-patentable under the provision of section 3(e) of the Patents Act, 1970,⁵ as there was no data in the specification to support the synergistic effect. Furthermore, it was also pointed out that few claims were not fairly based on the matter disclosed in the specification. These claims were objected u/s 10(5) of the Patents Act, 1970,⁶ as they claim for reduced sweet quality of high-intensity sweetener and a high solubility when compared to sugar. In addition, some claims were objected u/s 10(5) of the Patents Act, 1970 for using phrases like “at least one”, “mixtures thereof” and “combinations thereof” which makes the claim too broad, unclear and vague. The independent claim and the five dependent claims of the invention before and after amendment are given below:

In reference to the FER, the applicant/patent agent submitted suitably amended claims. As per the FER reply, the invention was novel as compared to the cited prior art by the controller. The applicant also submitted that the delimited sweetener composition offered unexpected and surprising technical effects in terms of an improved sweetness profile. The applicant stated that the claimed composition was synergistic and did not fall u/s 3(e) of the Act. Applicants also defended the use of the expression “at least” to define a lower parameter of a constituent particularly under instances where defining the higher range of the constituent was redundant. According to the applicant, the use of the terms “combinations thereof” and “mixtures thereof” was clear and coherent and these phrases were permissible expressions that justifiably fortify the claim against literal infringement through the usage of the defined components in combination. Hence, the usage of all these expressions did not contravene the provisions of section 10(5). In the controller’s decision over the application, it was stated that few objections remained outstanding even after amendments. The amended claims did not meet the requirement of section 10(5) of the Patents Act, 1970 as the language of the claims was unclear and vague. The applicant’s argument on unexpected and surprising technical effects of the sweetener composition was also rejected for not providing any data support. As per the controller’s decision, the amended claims did not meet the requirements of section 10(4)(b) of the Patents Act, 1970 as the amended claims covered a very broad range of taste modifiers, for which there were no working examples in the specification. In addition, few amended claims were also not allowed u/s 59 of the Patents Act, 1970.⁷ The application was refused on the grounds of section 15.⁸

2. NOVEL SWEETENER HAVING SUCROSE-LIKE TASTE, METHOD FOR PRODUCING THE SAME, AND USE OF THE SAME

Another patent application (4319/KOLNP/2009) described a novel sweetener having sucrose-like taste and method for producing/using the same.⁹ The application was related to a novel sweetener product which has sweetness qualities of a glucose/fructose liquid mixture. The claimed mixture claimed to not causing obesity because of having been obtained by treating glucose-liquid sugar, which was produced in a glucose-liquid sugar production plant, with isomerase and epimerase to thereby form D-psicose. The first examination report highlighted the lack of novelty and inventiveness. The examiner objected that the claims were statutorily non-patentable under the provision of clause (e) of Section 3 for not providing data in the description for a synergistic effect. Furthermore, examiner raised doubts on a few claims where the matter disclosed in claims were not fairly based on the specification. Given below is the comparison of the independent claim before and after the amendment.

Even after considering the submissions made by the applicant in response to the first statement of objections, it was observed that each technical feature of amended claims was fairly and/or completely disclosed in the cited prior art. The combined disclosure of prior art makes the claims of the amended application obvious to a person skilled in the art and hence did not involve any inventive step u/s 2(1)(ja) of the Patent Act, 1970. Also, some claims attracted the provision of section 3(e) of the Act, as no synergistic effect had been shown in the specification for the claimed composition. The objections in the first examination report (FER) under Section 12¹⁰ and 13¹¹ of Patents Act did not comply within the prescribed period. An opportunity of hearing under Section 14¹² of Patents Act was offered to the applicant. This application for grant of the patent was refused under Section 15 of the Patents Act, 1970.

3. SWEETENER COMPOSITION COMPRISING LACTASE AND PROCESS FOR PREPARATION THEREOF

Yet another patent application (240/MUM/2009) was related to a sweetener composition comprising lactase and process for preparation thereof.¹³ The application disclosed a sweetener, which has a sweetness equivalent to that of sucrose. This sweetener also facilitated the processing of foods sweetened with it by judicious incorporation of a biocatalyst, lactase. The main claim of the application is given below:

A low cost, low-calorie sweetener for use in the preparation of foodstuffs said sweetener comprising:

0.05 to 0.20% by weight of sucralose for providing high-intensity sweet taste and property of heat stability to the said sweetener;

98.50 to 99.65% by weight of low intensity sweetening agents to serve as a bulking agent and heat shield for the sweet taste of said sweetener;

0.3 to 1.3% by weight of lactase to aid the processing of foods; and

ingredients optionally selected from the group consisting of flavour enhancers, flavouring and the like for providing enhanced palatability and consumer preferences in respect of the said sweetener.

The examiner raised objection u/s 2(1)(j) of the Patents Act, 1970 in view of the prior art. Further, the claims were not patentable u/s 3(e) of the Patents Act, 1970 as the composition claimed was a mere admixture of high-potency sweetener, bulking agent and lactase without any demonstrated synergistic effect. The applicant argued that neither of the compositions disclosed in the cited prior art was capable of being used on a spoon-to-spoon replacement for sucrose/table sugar and therefore, not equivalent in any manner or function to the composition claimed in the application. In FER reply, the applicant/patent agent also stated that the disclosures submitted proved that the specific concentrations of ingredients were critical for the phenomenon to be achieved, which proved the synergy between said ingredients of the application. As per the controller’s decision, the applicant failed to meet all the objections raised in the hearing notice and also failed to meet the requirements of the Patents Act within the prescribed time after giving an opportunity for hearing under section 14. The application did not meet the requirements of Section 2(1)(j) of the Patents Act 1970. Therefore the grant of the patent was refused under the provisions of Section 15.

4. SWEETENER COMPOSITION WITH ENHANCED SWEETNESS

A different patent application (835/MUM/2005) titled sweetener composition with enhanced sweetness was also refused.¹⁴ The application was related to a sweetener composition comprising sucralose and a sweetness enhancing agent selected from the group consisting of fructo-oligosaccharide, neotame, stevia, neohesperidine, saccharides and thaumatin. The independent claim of the invention is as follows:

A sweetener composition comprising sucralose and a sweetness enhancing agent selected from the group consisting of fructooligosaccharide, neotame, stevia, neohesperidine, saccharides and thaumatin, wherein the ratios of the sucralose to the sweetness enhancing agent is in the range of 10:90 to 90:10 by weight, the balance if any comprising one or more conventional adjuvant such as bulking agents, diluents, viscosity modifiers, colouring agents.

According to the examiner’s objections, the claims did not constitute an invention u/s 2(1)(j) of the Patents Act, 1970 in view of the prior published documents. In addition, the claims were not patentable u/s 3(e) as the synergistic effect described was not clear and conclusive. The applicant in FER reply resisted the objections raised by the examiner by stating that the invention was novel and inventive over the cited prior art. The applicant further argued that the composition of the invention provided enhanced sweetness of the order of 600 to 2500 over sucralose and no metallic or bitter after taste was observed. Hence the invention did not fall under the ambit of section 3(e). The patent office rejected the submissions of the FER and concluded that the objections related to the novelty and synergistic effects were still outstanding. The patent application was refused under section 15 of the Patents Act 1970.

5. ENCAPSULATED COMPOSITIONS AND METHODS OF PREPARATION

One more patent application (1488/KOLNP/2007) was refused which was based on encapsulated compositions.¹⁵ The application revealed a sweetener composition comprising a co-crystallized / precipitated complex of cyclodextrin and sucralose; and an encapsulant comprising a polymer. As per the first examination report, the claims were not patentable under section 3(e) of the Patent Act, 1970 and did not involve an inventive step with respect to the prior art documents cited. A comparison of independent claim before and after the amendment is given below.

The controller was of the view that the arguments of the applicant/patent agent in respect of the novelty and inventive step were not persuasive. Furthermore, the synergistic effect was exemplified in the description, but the composition was just an admixture of cyclodextrin and sucralose. The application did not meet the requirement of Section 10(5) of the Patents Act 1970. Few claims lacked clarity in respect of the expression like “further comprises” etc. In addition, the particle size was also not defined properly by mentioning unit in the claim. According to the patent office decision, controller concluded that the technical feature of the amended claims was obvious over the combination of the prior art and the application was rejected.

6. ASPARTAME BASED LOW COST SWEETENER

One more application based on aspartame based low-cost sweetener (744/MUM/2009) was refused.¹⁶ The reason was the same as that of the other applications since the subject matter claimed in claims did not meet the requirement of section 2(1)(j) of Patents Act being obvious over the prior art. Besides, the claims were not patentable under the clause (e) of section 3 of the Act. The application explained a homogeneous sweetener composition containing aspartame and the process of manufacture. The main claim of the application is as follows:

A low-cost low-calorie sweetener composition for use in preparation, foodstuffs said composition comprising:

about 9-11% of aspartame by weight based on the total weight of the composition; and

about 89-91% filler by weight based on the total weight of the composition.

The objections raised in FER were related to the claims not meeting the requirement of section 2(1)(j), falling within the scope of clause (e) of section 3 of the Patent Act, 1970; not sufficiently defining the composition with their ingredients; using vague and unclear words, etc. Referring to objections contained in the examination report, the applicant replied that the invention was thoroughly distinct and capable of distinguishing itself from the cited prior art. The applicant also stated that neither aspartame nor the filler claimed in composition was capable of being used on a spoon-to-spoon replacement for sucrose/table sugar and therefore, the resultant composition was not merely the additive of their inherent properties. It was a specific calibrated blending which was not replicated in any prior art. Therefore, the invention did not invoke ingredients clause (e) of section 3 of the Act. The applicant maintained that a narrow range of 9 to 11% and 90 to 89% was claimed for both ingredients and provided a clear indication of the ratio of their blending. However, the objections related to claims not worded clearly in respect of the word like “about” would be replaced. Controller after seeing the submissions made by the patent agent concluded that subject-matter claimed did not meet the requirements of section 2(1)(j) and claims falling within the scope of clause (e) of section 3 of the Act. The applicants or their authorized patent agent failed to attend the hearing; hence, the objection raised during prosecution of the case remained outstanding on the last date. Therefore, in view of the above outstanding objections, the application was refused under section 15.

7. NEOTAME BASED LOW COST SWEETENER

A similar application on neotame based low-cost sweetener (745/MUM/2009) was also rejected.¹⁷ The application described a homogeneous sweetener composition containing aspartame having tasting properties similar to sucrose and the process of manufacture/use thereof. The claims of the application are as follow:

1. A low-cost low-calorie sweetener composition for use in the preparation foodstuffs said composition comprising:
   1. about 9-11% of neotame by weight based on total weight of the composition; and
   2. about 89-91% filler by weight based on total weight of the composition;
2. A low cost low calorie sweetener composition for use in preparation foodstuffs according to claim 1 wherein said filler is independently chosen among the group comprising sucrose, hi maltose corn syrup, invert sugar, fructose oligosaccharide and sorbitol;
3. A method to prepare a low cost, low calorie sweetener composition of claim 1, said method comprising steps of
   1. admixing neotame and said filler component for 30 to 55 minutes in a blender to achieve homogeneous dispersion of said components;
   2. optionally mixing ingredients selected from the group consisting of flavour enhancers, flavourings and the like for providing enhanced palatability and consumer preferences in respect of the said low calorie low cost dietary fibre composition.
4. A method for sweetening foodstuffs which comprises adding an amount of the sweetener of claim 1 to achieve a sweetened effect in foods, said sweetened effect being same as that produced by a weight-equivalent of sucrose.

The first examination report stated that the claims 1-4 were not patentable u/s 3(e) of the Patents Act, 1970. The composition claimed was just an admixture of neotame with filler without any demonstrated synergistic effect. The examiner objected on the language of the claims 1 & 3 for using terms like “about” and “the like”. These terms made the claims vague and indefinite and the applicant was asked to replace the terms. Next, the examiner objected that claim 4 was merely a statement of the underlying problem without any technical features. In response to FER, the applicant submitted that the invention stated in claims 1 to 4 was thoroughly distinct and capable of distinguishing itself from the cited references. The applicant argued that the specific concentrations of ingredients in the disclosures were critical for this synergistic phenomenon to be achieved and hence proved the synergy between said ingredients. As per the applicant, the said invention was entirely novel, non-obvious and capable of patent registration. Referring to objections related to the terms “the like” and “about” circumscribe boundary of the invention and thus claim intended without deviating from the essence of the invention indefinite. The controller found that the submission made by the patent agent did not comply with the objections raised in the first examination report under section 21(1).¹⁸ The objection raised during prosecution of the case remained outstanding, therefore, the controller refused to grant a patent on this patent application under section 15.

8. SWEET SUGAR FREE FLAVOURED PILLS FOR DIABETICS AND CALORIE CONSCIOUS PEOPLE

One more patent application on sweet sugar-free flavoured pills for diabetics and calorie conscious people (446/CHE/2009) was refused.¹⁹ These pills get easily dispersed and dissolved without stirring in drink and give sweetness equivalent to 1-3 teaspoons of sucrose. The claims of the application are as follow:

1. a sweet sugar-free flavoured pills for diabetic and calorie conscious people consisting essentially of an artificial sweetener or sweeteners (aspartame, sucralose) diluent, super disintegrants, lubricant, glidant, flavours;
2. Sweet sugar free flavoured pills as claimed in claim 1 having a diluent like pearlitol ® SD which increases the bulkiness of the pill is a spray dried mannitol and is quickly soluble in water so it hastens the disintegration of sweet sugar free pill;
3. Sweet sugar free flavoured pill as claimed in claim 1 consisting of optimum concentrations of superdisintegrants like cross povidone, cross carmellose sodium, sodium starch glycolate as these superdisintegrants play a major role in the disintegration and dissolution of pill;
4. Sweet sugar free flavoured pill as claimed in claim 3 wherein said superdisintegrants provide quick disintegration due to combined effect of swelling and water absorption by the pill, which promotes the wettability and dispersibility of the pill, thus enhancing the disintegration and dissolution;
5. Sweet sugar free flavoured pills as claimed in claim 4, when we put the pill into any drink, the drink penetrates into the tablet and replaces the air adsorbed on the particles, which weakens the intermolecular bonds and breaks the pill into fine particles thus enhances the dissolution of the pill ultimately going into solution;
6. Sweet sugar free flavoured pills as claimed in claim 1 consisting of microcrystalline cellulose in the concentration of 10-25% provides compressibility and allowing water to enter the pill matrix by means of capillary pores, which break the hydrogen bonding between adjacent bundles of cellulose microcrystals and exhibit very good disintegrant property thus it enhances dissolution of pill;
7. Sweet sugar free flavoured pills as claimed in claim 1 consisting of a flavouring agent like ginger oil, cinnamon oil, cardamom oil, clove oil, lemon oil, orange oil, fennel oil, caraway oil, pepper oil, mentha oil, coriander oil or mixture of these oils which enhance the palatability and taste of the drink;
8. Sweet sugar free flavoured pills as claimed in claim 1 containing lubricant and glidant like sodium starch fumarate and colloidal silicon dioxide to facilitate the compression operation in the proportion of 0.2 – 2% in weight of the total weight of the pill;
9. Sweet sugar free flavoured pills as claimed in claim 1 consisting of (a) 5-40% of artificial sweetener; (b) 83-22% by weight of diluent (spray dried mannitol); (c) 10-25% by weight of micro ciystaWin cellulose; (d) 2-I0%byweightofsuperdismtegrants; (e) 0.01-1% of flavouring agent; (f) 0.2-2% by weight of lubricant and glidant.

As stated in the first examination report, the main claim and its dependent claims were not patentable u/s 3(e) of the Patents Act, 1970 as there is no support in the description for any synergistic effect. Also, the independent claim was too broad and claimed more than one artificial sweetener. As per FER, claim 2 was indefinite with reference to use of the Trademark in the claim. Further, the examiner pointed out that claims lacked an inventive step in view of the cited prior art. The examiner raised issues on claim 3 to use of the phrase “optimum concentrations” which was vague. Other objections raised by the examiners were related to claim 9 which were not clear with reference to the percentage range weight of diluent in (b). In controller’s decision, it was stated that all the requirements of objection communicated did not meet and the application was refused for grant of a patent under section 15.

9. REDUCED CALORIE SWEETENER COMPOSITION

A granted patent (278/MUMNP/2007) was related to a reduced calorie sweetener composition.²⁰ This application described a reduced calorific sweetener composition without loss of favourable organoleptic properties associated with incorporating sugars and other non-sugar low-intensity sweeteners. The main objection raised in the first examination report was regarding claim 1 which did not clearly define the composition. The second objection was related to the lack of novelty & inventive step as being anticipated in light of prior art. The objections raised by the examiner related to not clearly defining the composition, lacking novelty and inventiveness were successfully defended by the applicants. Then the applicants defended the examiner’s first objection by stating that the independent claim was clearly worded with respect to relative sweetness contribution rather than in % or proportion of components used for the preparation of compositions. Also, the applicant amended the independent claim to restrict the low-intensity sweeteners to “low-intensity sweeteners containing at least Sucrose”. The second objection was also defended by stating that the prior art disclosed a sweetener composition comprising spheroids or part spheroids of microcrystalline sucrose which was excluded in the independent claim of the present invention.

Even after the submission by the applicant/patent agent, few objections were outstanding related to claims under section 2(i)(j) and the definitiveness in the absence of method step. The applicant further amended the objected claims and method step was incorporated. The amendments incorporated were carefully reviewed by the controller and the patent was granted.

CONCLUSION

The detailed analyses of the rejected patent applications on the artificial sweeteners by the Indian Patent Office suggest that the grounds of rejection include lack of novelty, lack of inventiveness and falling under section 3(e) of the Patents Act, 1970. All rejections are done under section 15 by the Indian Patent Office without any third party involvement. The clarity of expression is very important while drafting and claims should be fairly based on the specification. This study provides a good insight into how applications for composition should be drafted, specifications should provide supporting data for the synergism and the use of vague terms should be avoided.

Note: The article is for information purpose only and for any legal advice one should consider consulting with an attorney.