TK explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Paragraph 14 of the 2012 Guidelines on traditional knowledge (TK) is the part that most often shapes an office action: six guiding principles that tell examiners how to judge novelty and inventive step when the prior art is a traditional record. The illustrations use citations from the Traditional Knowledge Digital Library (TKDL). This article explains each principle, the illustration the Guidelines give, and how an applicant can answer it. The screening, Form 1 and NBA permission parts are in our other article on the 2012 Guidelines.
The Guidelines are the Patent Office's guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as now in force prevail. The Office revises its guidelines, so check the current version on ipindia.gov.in.
When the use of a plant or ingredient is already known from traditional knowledge, the 2012 Guidelines treat its extract, its isolated active, a combination of known plants, a range of known ingredients and a single component taken from a known formulation as not novel or not inventive. A surprising (superior) effect is the answer the Guidelines themselves mention. The Ayush Guidelines 2025 restate and extend these principles; see the Ayush articles for the 2025 wording.
How the Guidelines frame the exercise
The Guidelines call inventive step the final gatekeeper of the patent system. For TK-based inventions, the six principles "must be followed" in assessing novelty and inventive step (paragraph 14). Each is followed by one or two illustrations, in which a TKDL entry is the prior art. The paragraph after the principles adds that sections 3(c), (e), (i), (j) and (p) are to be strictly applied (paragraph 15). The section 3(p) bar on an invention which is in effect traditional knowledge is explained in our article on the Manual's section 3 clauses.
The Ayush Guidelines 2025 restate and extend the same six principles for Ayush inventions, and they are covered in the first three principles and principles 4 to 6. This article stays with the 2012 text.
The six principles in the 2012 text
| Principle | What it says in short | Illustration in the Guidelines (our summary) |
|---|---|---|
| 1. Extracts and isolated actives | An extract, alkaloid or isolated active that is naturally present in a plant is not novel or inventive when the plant's use is pre-known as TK. An undefined extract is not novel; a characterised alkaloid may be new but lacks inventive step, since prior art motivates isolation | A plant extract for stress where TKDL shows use of the root; and a glycoside from chamomile where TKDL shows chamomile's use for the same conditions |
| 2. Combination of known plants | A combination of a plant with a known effect and further plants with the same known effect, all known for the same disease, is obvious; an additive effect is expected | A three-plant wound composition; and a four-ingredient composition for male fertility where none of the sources discloses the combination but each single use is known |
| 3. Combination with one known ingredient | If one ingredient is known for a disease, a presumption arises that a combination containing it will work for that disease | A five-constituent vitiligo combination where one constituent is known; inventive merit is not acknowledged without a surprising, superior effect |
| 4. Optimum or workable ranges | Finding the optimum range by routine experimentation is not inventive | A formulation of plant extracts in percentage ranges, obvious over a traditional text on two of the plants as an oil |
| 5. Taking one component out | If several ingredients are known to have the same activity, taking out one is not inventive | An extract of one ginger species for inflammation and asthma where a traditional formulation containing it was known |
| 6. Additive effect of known ingredients | Where each ingredient is known for the disease, a combination with further plants of the same effect is expected to work better than each alone | The same three-plant wound composition; and a tea-component and herb combination for colds and influenza where both are known separately |
Principles 2 and 6 overlap in the 2012 text: both rest on the additive effect, and they share one illustration. In practice an examiner may cite either.
How the 2012 wording differs from the 2025 Ayush wording
The 2012 principles are stated in firm terms, and the 2012 Principle 1 does not expressly say that a process for obtaining an extract may still be patentable; the 2025 Ayush text adds that, and adds an express route through specific ratios with an unexpected effect for combinations. This is why the Ayush articles in this series are worth reading beside this one, and why a reply to an objection on a TK-based application should use the current guidelines and the Act and Rules as now in force, which prevail.
How an objection is framed and answered
An objection on these lines typically has three parts: the TKDL citation, a statement of what the traditional text teaches, and a reasoned conclusion that the claimed subject matter is not novel or not inventive. A reply can be built in the same three parts.
- Read the citation. The Guidelines send a copy of any TKDL citation, translated into English, with the examination report. Check what part of the plant is named, which disease, and which system.
- Find the real gap. Compare the claim with the citation feature by feature. A difference in plant part, in processing, in dosage form or in indication may matter.
- Bring data. The Guidelines' own language points to a surprising (superior) effect in the combination case. Comparative data, with each ingredient alone and the combination, is the evidence.
- Consider a process or product-by-process claim. Where the product claim is not defensible, a claim to a new process may stand on different reasoning, subject to the usual tests.
- Keep the disclosure in order. The source and geographical origin of any biological material, and the Form 1 declaration, should be in place as explained in the companion article.
If you have a TKDL-based objection on a herbal or traditional-knowledge application, our patent objection reply service can structure the reply and the data.
Checklist table
| What the examiner asks | What the applicant shows | Principle |
|---|---|---|
| Is the plant's use in the TKDL record? | The distinguishing plant part, form or use | 1 |
| Is the compound just isolated from a known plant? | New process, or a feature beyond isolation | 1 |
| Are all plants known for the same disease? | Surprising, superior effect over each alone | 2, 6 |
| Is one ingredient known for the disease? | Surprising effect against the known product | 3 |
| Is the range a result-effective variable? | Evidence that the claimed range is critical | 4 |
| Is the ingredient just taken from a known formulation? | A new activity or better result | 5 |
A worked example
Tulsi Sanjeevani Pvt Ltd files for a drink containing three herbs for immunity. The examiner cites a TKDL record showing each herb used separately for colds, and objects under Principle 6 that the combination is obvious. Tulsi replies with data on each herb alone and on the combination at the claimed ratio, claims only that ratio and adds a process claim for the extraction. The Controller considers the data and the narrowed claims at a hearing.
Common lapses
- Replying only that the combination is "novel" when each herb is known.
- No comparative data against each ingredient alone.
- Claiming wide ranges with no basis in the specification.
- Missing that a TKDL entry names a different plant part.
- Neglecting Form 1 and source disclosure while arguing inventive step.
Need help with a TK-based reply?
TKDL objections can be answered when the data and the claims are planned together. If you have received one, see our patent objection reply service for support on the evidence and the amended claims.
Key takeaways
- The 2012 Guidelines give six principles for novelty and inventive step in TK-based inventions.
- A pre-known traditional use defeats claims to extracts, isolated actives, known combinations and ranges.
- A surprising, superior effect is the answer the Guidelines themselves recognise for combinations.
- The 2025 Ayush Guidelines restate and extend the principles.
- Use the Act and Rules as now in force and the current guidelines in any reply.
Read next
- TK Guidelines 2012: screening, Form 1 and NBA permission
- Ayush Guidelines 2025: guiding principles 1 to 3
- Ayush Guidelines 2025: guiding principles 4 to 6
- Chapter 9: section 3(l) to (p) and traditional knowledge
Disclaimer: Based on the manuals and guidelines published by the Office of the Controller General of Patents, Designs and Trade Marks that are named in the article, as consulted on 4 October 2026. They are guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as amended (including the 2024 amendment rules) prevail, and the current versions on ipindia.gov.in should be checked. This article is general information, not legal advice; check the official text before acting.