Freedom-to-Operate Checklist: Scope, Search, Claim Charting, and Design-Around

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A freedom-to-operate analysis fails in predictable places: the wrong search is run, the product is never decomposed, hits are charted before they are screened, the file wrapper is never read, and the report arrives after the design is frozen. This checklist runs the exercise in twelve phases to prevent each of them - scope, decompose, define jurisdictions, search, screen, chart, read the file wrapper, assess invalidity where it matters, design around, decide about opinions, report and allocate, then refresh. Each box gives the reason, the authority, and the trap. A worked matter follows one product from scoping to launch. The companion article explains what the exercise can and cannot establish, and the companion guide walks the method.

IP and Technology > Patent Counseling Transactions | Checklist | Published 21 June 2024 - Updated 13 October 2025 | Casey Scott McKay - marksy.us

Summary. A freedom-to-operate analysis fails in predictable places: the wrong search is run, the product is never decomposed, hits are charted before they are screened, the file wrapper is never read, and the report arrives after the design is frozen. This checklist runs the exercise in twelve phases to prevent each of them — scope, decompose, define jurisdictions, search, screen, chart, read the file wrapper, assess invalidity where it matters, design around, decide about opinions, report and allocate, then refresh. Each box gives the reason, the authority, and the trap. A worked matter follows one product from scoping to launch. The companion article explains what the exercise can and cannot establish, and the companion guide walks the method.

Keywords: freedom to operate checklist, FTO scoping, feature decomposition, patent screening, claim charting, file wrapper review, design around, doctrine of equivalents, prosecution history estoppel, continuation monitoring, opinion of counsel, privilege, supplier indemnity, product launch gate, jurisdiction selection, risk assessment, invalidity screen, standards declaration, refresh cycle, report drafting


How to use this checklist

| Phase | What it covers | Who owns it | When | |---|---|---|---| | 1 | Scope the engagement | Counsel + client | First | | 2 | Define the product | Counsel + engineering | Before searching | | 3 | Decompose and rank features | Counsel + engineering | Before searching | | 4 | Define jurisdictions and horizon | Counsel + business | Before searching | | 5 | Search | Counsel or searcher | Weeks 2–4 | | 6 | Screen | Counsel | Immediately after | | 7 | Chart | Counsel + engineering | On the short list | | 8 | Read the file wrapper | Counsel | On each charted patent | | 9 | Assess invalidity, selectively | Counsel | Real risks only | | 10 | Design around | Engineering + counsel | Before design freeze | | 11 | Report, opine, allocate | Counsel | End | | 12 | Refresh | Counsel | Ongoing |

Phases 1 through 4 determine the cost. Phase 6 determines whether the budget reaches the patents that matter. Phase 10 is the only phase that removes risk rather than measuring it. Boxes marked [Gate] should clear before the next phase begins.

The matter. Kellerman Instruments planned a launch in five months for a portable spectrometer with a new calibration routine. Counsel was asked for "a patent search." The engagement began with the question of which search, and the answer changed the project.


Phase 1. Scope the engagement


Phase 2. Define the product


Phase 3. Decompose and rank features


Phase 4. Define jurisdictions and horizon


Phase 5. Search


Phase 6. Screen before charting


Phase 7. Chart the short list


Phase 8. Read the file wrapper


Phase 9. Assess invalidity, selectively


Phase 10. Design around

Kellerman, Phase 10. Two patents charted as real risks. One resolved on a narrowing amendment in the file wrapper that had surrendered exactly the configuration Kellerman used. The other required moving a computation from runtime to calibration time — three engineering weeks, adopted eleven weeks before design freeze, and unavailable at any price four months later.


Phase 11. Report, opine, and allocate


Phase 12. Refresh


Phase 13. Sector-specific screens

The general phases hold; the risk profile and the practical moves differ by field.

Software and platform products

Life sciences and medical devices

Hardware, components, and manufacturing

Phase 14. Cost, and where it goes

| Item | Relative cost | What determines it | |---|---|---| | Scoping and product definition | Low | One or two meetings | | Feature decomposition and ranking | Low | The single largest cost lever | | Landscape scan | Low | Breadth of the technology area | | Knockout search, per feature per jurisdiction | Low to moderate | Number of features times jurisdictions | | Screening | Low | Volume of hits, and it removes most | | Claim charting, per patent | Moderate | Claim complexity and product complexity | | File wrapper review, per patent | Low | High return per hour | | Invalidity assessment, per patent | High | Depth of the prior art search required | | Design-around development | Variable | Engineering effort, not legal | | Written opinion, per patent | High | Reserved for genuine risks | | Report drafting | Moderate | Number of features and patents covered | | Annual refresh | Low to moderate | Much cheaper than the original |

Three observations that shape the budget.

The decomposition determines everything downstream. Fifteen features across three jurisdictions is not five times the cost of three features across one — it is closer to fifteen times, because search, screening, charting, and reporting all scale with the product of the two.

Screening is the cheapest phase and it removes the most work. A project that reaches charting with three hundred patents has skipped it.

The design-around is the only phase that reduces risk. Everything else measures it. A budget that funds a thorough analysis and no engineering time to act on it has bought a description of a problem.

And the timing point, which is not about money. The same analysis run at design freeze minus one quarter and at design freeze plus one month produces identical findings and entirely different options. Practitioners cannot control when they are engaged, and they can say plainly at the first meeting what the difference costs.

Phase 15. The FTO gate in a product development process

For a company shipping products regularly, FTO should be a gate rather than a project, and the design of that gate determines whether it works.

Phase 16. When the analysis follows a demand letter

An FTO analysis run after contact is a defense rather than a plan, and four things change immediately.

A closing note on how this checklist gets used badly. The most common misuse is running Phases 5 through 8 thoroughly and Phases 1 through 4 not at all — a rigorous search of a product nobody defined, in jurisdictions nobody listed, at a depth nobody allocated. The result looks like diligence and answers no question the business asked. The second most common is running everything except Phase 10, producing an excellent description of risk with no engineering time budgeted to remove any of it. And the third is running the whole thing once, filing the report, and treating it as permanent, when new patents issue continuously and the families identified as risks are precisely the ones with continuations pending. Scope deliberately, act on the findings, and refresh — and the exercise repays itself many times. Do the middle phases beautifully and skip the ends, and it is an expensive document.

Kellerman, outcome. The product shipped on schedule. Of the fourteen features analyzed, nine required no work, three were supplied under indemnities that were verified rather than assumed, and two produced charts warranting attention. One of those resolved on the file wrapper. The other produced a three-week engineering change adopted before design freeze. Total legal cost: a fraction of one month of the litigation it did not have.

The company now runs the gate at design freeze minus one quarter on every program, and maintains the feature-risk map between cycles.

Key Authorities at a Glance

| Authority | Proposition | Phase | |---|---|---| | 35 U.S.C. § 271(a) | Making, using, offering, selling, importing | 1, 4 | | 35 U.S.C. § 271(b) | Inducement; requires knowledge | 11 | | 35 U.S.C. § 271(c) | Contributory infringement | 3 | | 35 U.S.C. § 271(f) | Components supplied for combination abroad | 4 | | 35 U.S.C. § 271(g) | Products made abroad by a patented process | 4 | | 35 U.S.C. § 101 | Eligibility as an invalidity ground | 9 | | 35 U.S.C. § 112(a) | Enablement and written description | 9 | | 35 U.S.C. § 112(f) | Means-plus-function construction | 7 | | 35 U.S.C. § 120 | Continuations; the invisible risk | 8 | | 35 U.S.C. § 122(b) | Publication at eighteen months | 1, 11 | | 35 U.S.C. § 154(b) | Term adjustment | 6 | | 35 U.S.C. § 282 | Presumption of validity | 9 | | 35 U.S.C. § 284 | Damages and enhancement | 11 | | 35 U.S.C. § 285 | Fees in exceptional cases | 9 | | 35 U.S.C. § 298 | Failure to obtain advice not evidence of willfulness | 11 | | 35 U.S.C. § 311 | Inter partes review grounds | 6, 9 | | 35 U.S.C. § 321 | Post-grant review grounds | 9 | | 35 U.S.C. § 41(b) | Maintenance fees | 6 | | 37 C.F.R. § 1.321 | Terminal disclaimers | 8 | | 28 U.S.C. § 2201 | Declaratory judgment | 11 |


The five things people get wrong

One: they run the wrong search. A patentability search examines disclosures and asks whether a patent is obtainable. An FTO analysis examines in-force claims and asks whether the product can be sold. Reporting the first as clearance for the second is the most consequential confusion in this practice.

Two: they never decompose the product. Searching "the product" produces a project that is unaffordable and shallow at the same time. Eight to fifteen ranked features, with depth allocated by rank, is what makes the exercise both useful and payable.

Three: they chart before screening. Status, expiry, independent claims only, one missing element. Most hits die there for almost nothing, and the budget then reaches the patents that matter.

Four: they skip the file wrapper. Narrowing amendments limit equivalents and frequently convert an alarming claim into a manageable one. It costs almost nothing and it is omitted because it does not appear in search results.

Five: they run it too late. After tooling, contracts, and inventory, the findings are identical and the options are gone. The entire value of the exercise is the window in which design changes are still cheap. See Running a Freedom-to-Operate Analysis.


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This document is general information about the law, not legal advice, and does not create an attorney-client relationship. Patent outcomes turn on specific claims, records, and dates. Marksy is not a law firm.

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