It has been observed that the Controllers of the Indian Patent Office raise certain objections in the Examination Reports, which are common in most of the patent applications. These objections are basically not technical in nature but are non-technical in nature. Therefore, this article aims towards providing insights to these objections and the strategies to reduce or eliminate such objections, which eventually expedite the disposing off of the patent applications.
Upon reviewing and prosecuting several patent applications, it has been noted that these objections are basically raised on the language of claims. The reason or purpose behind these objections is to bring the language of claims in line with the Indian Patent Practice. Hence, this article will now throw light on some of these objections and will provide approaches to reduce the chances of raising these objections in the Examination Reports:
- Claims reciting ranges of the components in a "or
more" or "or less" format
As per claims drafting practice across the globe, the drafters strategically keep the ranges of the components open-ended by using the terms such as 'or more' or 'or less.' For example: "wherein the range of density of component X is 1.12 g/cm 3 or more." Such type of drafting practice is considered broad and vague as the upper end of range covers numerous possibilities. Thus, the protection which is sought in the claim would be unclear. Therefore, it is advisable to draft claims by reciting ranges in specific numbers, such that the ranges are not too broad, so that the scope of claims can be properly defined. For example: "wherein the range of density of component X is 1.12 g/cm 3to 5 g/cm3." Thus, claims drafted in such a manner shall be considered clear and concise.
It is also advisable to include working examples with the lower limit of the range claimed and upper limit of the range claimed to demonstrate that the components work or cater to the objective, the invention is trying to achieve, in the claimed range.
- The terms such as "about", "up to",
"according to," "or the likes" are considered
objectionable under the Indian Patent law:
Claims reciting the terms such as "about," "up to," "or the likes" or similar terms are considered ambiguous by the Indian Controllers. It is because these terms leave a room for different interpretation. For example: claims drafted in a manner like "wherein the concentration of compound A is up to 3 mg," or "wherein the concentration of compound A is about 3 mg," or "wherein the compound A is selected from the group consisting of calcium carbonate, sodium carbonate or the likes." Upon reading these claims, the terms such as "up to" and "about" used in the claims suggest that the concentration can be 2.9 or 2.8 but do not suggest the definite value of concentration to be 3 mg per se. Therefore, these terms are considered as vague by the Indian Controllers. Similarly, the phrase "or the likes" does not define the boundary for which the protection is sought as the said phrase is open-ended.
Given the above, it is advisable that the usage of these terms should be avoided as these terms attract the clarity objections. Instead, ranges or examples in claims should be defined by using a definite term. Therefore, claims drafted in a manner like "wherein the concentration of compound A is within the range of 3 mg to 10 mg," or "wherein the concentration of compound A is within the range between 3 mg to 10 mg," or "wherein the compound A is selected from the group consisting of calcium carbonate, sodium carbonate or potassium carbonate" are acceptable in the Indian Patent Practice.
- Multiple dependencies on claims may be objected under
the Indian Patent law
It has been observed that some claims having multiple dependencies on the preceding claims are objected by the Indian Controllers but some are not. Those dependent claims that refer to such other precedents claims in the alternative form seem to be accepted by the Indian Controllers. This is because, for any given embodiment, a claim having multiple dependencies does not contain all the limitations of all the alternative claims to which it refers, but rather contains only those limitations of the particular claim referred to for the embodiment under consideration. A claim having multiple dependencies must therefore be considered in the same manner as a plurality of single dependent claims. For example: "the compound as claimed in any one of claims 3 or 4" is acceptable form whereas "the compound as claimed in claims 3 to 4" is not. The reason being is latter claim does not define clearly that which embodiment it aims to cover. The dependent claims should have their dependencies explicitly disclosed.
Therefore, those dependent claims having multiple dependencies written in the alternative forms are acceptable under the Indian Patent law, thus it is advisable to draft multiple claims in such manner to avoid unnecessary objections.
- Claims without reciting a technical/structural features
are objected by the Indian Controllers:
Claims such as "[a] composition comprising a compound as claimed in any one of claims 1 to 10" or "[a] laminate prepared using the process as claimed in any one of claims 1 to 10" are mostly rejected by the Indian Controllers. It is because these claims do not recite any technical feature or structural features of a product. For example: in first example, a composition merely recites that it contains a compound but does not recite any technical feature of a composition. As we are aware that the composition must contain more than one ingredient and as per Indian Patent law, the composition of claim must also show synergistic effects with respect to each ingredients of the composition. Therefore, in absence of such technical features and data of synergistic effects, such claims are considered vague.
Similarly, in the latter example, merely reciting a laminate without reciting its technical features and just mentioning it is prepared by the process of previous claims would not be considered acceptable by the Indian Controllers.
Therefore, it is advisable to draft a product or composition by claiming its proper technical/structural features. Further, the data supporting its technical advantages should be mentioned in the specification to avoid any future objections.
In instances, where the claims are directed towards antibodies, wherein the claims are drafted in terms of its antigen sequence, for example a claim reciting "An antibody binding to an antigen of Sequence Id No.1". Many Controllers often raise objection to define the antibody in terms of its structural feature rather than in terms of the antigen. Therefore, it is always preferable to include the structural features of the antibody such as the sequence of CDR regions, Fc regions, and constant regions of the light and heavy chains at least in the dependent claims.
- Product by process claims
Patentability criteria of product by process claims are not defined in the Indian patent statute. However, the guidelines for examination of patent applications in the field of pharmaceuticals issued in Oct 2014, defines specifically by referring to the IPAB case held in ORDER No. 200/2012 which states "even though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself."
In order to distinguish the product claimed in terms of product by process from the prior art, one must be able to establish the novelty and inventive step of the product regardless of the process from which the product is obtained. Therefore, in the Indian jurisdiction patentability of the product by process claims depends only on the patentability of product irrespective of the process from which it is obtained. Thus, it is advisable if the features of the product itself is not novel and inventive, then drafting of product by process claims should be avoided.
- Overly broad Markush claims
Please be advised that the Indian Controllers are reluctant to grant overly broad Markush claims. For example, if the inventions lie in the compound containing ethyl-pentyl (C2-C5), the Markush claim can, at best, cover C10. Claiming till C30 will be considered as overly broad. Therefore, it is advisable to avoid such drafting practice.
- Use claims and Swiss type claims
Usually claims in the format "[a] composition "X" for use in treating a disease "Y" or "[a]n article obtained by casting the polymeric composition "X" in a solid mold" or "[a] process of preparing article using the compound as claimed in claim 1," are not allowed by the Indian Controllers until/unless they recite a technical or structural features of a composition or an article or process. Further, claims reciting a use of a product, for example, "[u]se of compound X for treating disease," is straight away not allowed.
The claims as illustrated above and the like are deemed to be non-patentable in India as in absence of any technical features related to a product, they are considered to be a "use" claim instead of a product claim.
In order to fulfil the requirement of patentability as per the Indian Patent Act, every subject matter should satisfy the criteria of an invention as per Section 2(1)(j) of the Indian Patents Act i.e., invention means a new product or process involving an inventive step and capable of industrial application. As per absolute definition of an invention, the subject matter has to be a product or process. Most of the Indian Controllers during oral hearing straightaway reject use claims or use claims in disguise of product or process claims, however very few Controllers allow a single application claim in the set of claims, which is written in a format of a product or process claims. Therefore, allowance of such use/application claims are upon the sole discretion of the Controller and practice varies among the Controllers. Hence, it is advisable to avoid drafting such claims in the Indian patent applications or remove such claims while entering Indian jurisdictions, in case of the international applications.
- The terms such as such as "at
least", "and/or", "one or more"
are considered objectionable under the Indian Patent
law:
Usually in the examination reports, Indian Controllers quite often object the terms such as "at least, and/or, one or more, combination thereof, mixture thereof." Please note that such terms often render the claims unclear and is open to the interpretation of the person reading the claims. The aim of raising such objections by the Indian Controllers is that the claims should clearly define the scope of the invention.
For instance, in a claim reciting "A composition comprising at least one active component X selected from group....."
The term "at least" implies that claims should include one element X but may also include more than one element such as Y, Z etc. Since several other elements are envisioned by the above claim, the term "at least" are usually objectionable.
However, to overcome the above objection, it is suggested to duly support such terms with working example. For instance, the working example may demonstrate that the composition comprising at least a component X caters to the object of the invention and another example showing the composition comprising components X and Y also cater to the object of the invention. This will substantiate the claim that composition can have only X or can include more than one component X such as Y and still perform the intended objective of the invention. The same advice is applicable for the usage of terms "and/or, one or more, combination thereof, mixture thereof."
- Working examples and enablement- Sufficiency of
disclosure
A disclosure of the complete specification must be sufficient enough for a skilled person to carry out the whole width of the claimed invention, without any undue burden. Further, the specification should disclose the best mode of performing the invention.
Emphasizing on the above, the specification should incorporate working examples demonstrating how the claimed invention achieve the objective of the invention. For instance, if the invention claims a composition for treating cancer, the examples should clearly demonstrate how the composition treats cancer preferably, comparing its efficacy in treating cancer with composition of the prior arts. Mere illustration of dosage forms and the clinical treatment strategy may not be sufficient.
Further, some Controllers require to restrict the claims to representative compounds in the working examples. Therefore, if a compound is selected from a group belonging to polysaccharide, ketones etc., it is advisable to show in working examples with the help of a representative working component of each category such as cellulose from polysaccharide, propanone from ketone. Lack of sufficiency of disclosure is also a ground for pre grant opposition, post grant opposition, and revocation of patent.
Conclusion
The purpose behind this article is to provide guidance to the Applicant(s) of national and foreign jurisdictions regarding the avoidable objections that reduces the time for disposing off the applications. The above-mentioned objections are some of the objections that have been observed in at least 4 examination reports out of 5. Therefore, while keeping the above mentioned advises in mind, one can draft the patent applications as per the Indian Patent Practice and can aid in smooth prosecution of the patent applications.
Superintendent By: Dr. Joshita Davar Khemani
Managing Partner, L.S. Davar & Co.
Linkedin Profile: https://www.linkedin.com/in/dr-joshita-davar-khemani-7b7bbb112/
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
