Duty of Candor Checklist: Who Is Bound, What Is Material, Timing, Cross-Citation, and Litigation Overlap

By Casey Scott McKay · 2025-01-04

This checklist installs a candor programme designed so that nobody has to exercise judgment under pressure, which is the failure mode the doctrine punishes. It begins by naming who is actually bound under Rule 56 and briefing them in one page with a single instruction. It then installs the four routing rules that close the categories producing almost every modern unenforceability finding - litigation contentions, foreign search reports, regulatory submissions, and the company's own product history. It specifies information disclosure statement mechanics window by window, automatic cross-citation as a docketing action, and the one-line disposition note that forecloses a deceptive-intent inference years later. It works the declaration protocol, the supplemental examination assessment including an honest survival analysis, legacy portfolio scoping, defending an allegation, and the annual test that settles whether any of it works.

IP and Technology > Patent Counseling Transactions | Checklist | Published 4 January 2025 - Updated 4 March 2025 | Casey Scott McKay - marksy.us

Summary. This checklist installs a candor programme designed so that nobody has to exercise judgment under pressure, which is the failure mode the doctrine punishes. It begins by naming who is actually bound under Rule 56 and briefing them in one page with a single instruction. It then installs the four routing rules that close the categories producing almost every modern unenforceability finding — litigation contentions, foreign search reports, regulatory submissions, and the company's own product history. It specifies information disclosure statement mechanics window by window, automatic cross-citation as a docketing action, and the one-line disposition note that forecloses a deceptive-intent inference years later. It works the declaration protocol, the supplemental examination assessment including an honest survival analysis, legacy portfolio scoping, defending an allegation, and the annual test that settles whether any of it works.

Keywords: bound individual list · one page briefing · litigation art routing · foreign search report transfer · regulatory review trigger · own product history · automatic cross-citation · IDS timing windows · safe harbor statement · content requirements · disposition in writing · declaration verification · comparator selection · supplemental examination assessment · survival analysis · legacy portfolio scoping · pleading challenge · privilege in defense · annual test · docketing configuration

How to use this checklist

| Phase | What it covers | |---|---| | 1 | The bound-individual list | | 2 | The one-page briefing | | 3 | Litigation art routing | | 4 | Foreign search reports | | 5 | Regulatory review trigger | | 6 | The company's own history | | 7 | Automatic cross-citation | | 8 | IDS timing windows | | 9 | IDS content | | 10 | Disposition in writing | | 11 | The declaration protocol | | 12 | Comparator and data selection | | 13 | When a problem is found | | 14 | Supplemental examination | | 15 | Survival analysis | | 16 | Legacy portfolio scoping | | 17 | Defending an allegation | | 18 | Privilege in the defense | | 19 | Docketing configuration | | 20 | Sector patterns | | 21 | The annual test | | 22 | Reporting |

Boxes marked [Gate] must clear before an application is filed, a declaration is executed, or a supplemental examination request is submitted.

The matter. A medical device company learned eight months late that litigation counsel had received an invalidity contention chart citing a reference that read directly on a limitation in a then-pending continuation. Nobody had a routing rule.

Phase 1. The bound-individual list

[ ] [Gate] Name, per application: each inventor; each attorney or agent preparing or prosecuting; and every other person substantively involved who is associated with the inventor, the assignee, or anyone obliged to assign, per 37 C.F.R. § 1.56.
[ ] Include the categories people forget — in-house counsel supervising outside counsel, technical staff who reviewed a draft, a scientist who supplied declaration data, a regulatory lead who reviewed the specification.
[ ] Do not overbreathe. The duty does not reach the whole company or an executive with no substantive involvement.
- Trap. A person on the list who was never briefed is worse than a person not on it.
[ ] Keep the list in the matter file and update it when someone joins.
[ ] Re-issue for each new family member, since continuations acquire new participants.

Phase 2. The one-page briefing

[ ] [Gate] Deliver it in person or by video, once, for five minutes, when someone joins an application.
- Trap. A briefing emailed and unread accomplishes nothing, and the delivery record matters if intent is ever litigated.
[ ] State what the duty is — disclose information material to whether the claims should issue, meaning the claims probably would not have been allowed had the examiner known.
[ ] State what it is not — no duty to search, no duty to form a legal opinion, no duty to explain or characterize.
[ ] State that it runs throughout pendency, not only at filing.
[ ] List what counts — publications and patents; products, systems, or software sold, used publicly, or offered for sale, including the company's own; papers and talks by the inventors; art cited in any litigation, office proceeding, or foreign office; testing results bearing on what was told the office.
[ ] [Gate] Give the single instruction: send it to prosecution counsel; do not decide yourself. Sending something irrelevant costs a line on a form.
[ ] Add the declaration paragraph — read every sentence, confirm personal knowledge, because a sworn statement known to be inaccurate is the most serious version of this problem.

Phase 3. Litigation art routing

[ ] [Gate] Five business days, to prosecution counsel, logged, dispositioned in writing.
- Why. This is the highest-value control in the programme, and it costs nothing.
[ ] Cover every source: invalidity contentions, post-grant petitions, third-party submissions, prior art charts, and expert reports.
[ ] Put the obligation in the litigation engagement letter, so it is a term rather than a favor.
[ ] Resolve the objection once. Submission is not an admission of materiality or prior art status, and the transmittal can say so.
[ ] Include post-grant counsel, frequently a third firm and the most commonly missed.
[ ] Run it in reverse too — tell litigation counsel what was submitted and when, since a file wrapper showing timely submission of the asserted references is a useful fact they will not know exists.

Phase 4. Foreign search reports

[ ] [Gate] Transfer to domestic prosecution counsel on receipt.
[ ] Name the owner of the transfer where different firms handle different jurisdictions.
[ ] Use the safe harbor. 37 C.F.R. § 1.97 provides timing relief for information first cited by a foreign office within three months — designed for exactly this and useless if nobody forwards the report.
[ ] Cover examination reports, oppositions, and third-party observations, not only search reports.
[ ] Diary the three-month window from the foreign citation date, not from the date domestic counsel received it.

Phase 5. Regulatory review trigger

[ ] [Gate] Prosecution counsel reviews any regulatory submission describing a product with pending applications, before filing.
[ ] Look for three things: prior art; admissions about what was known in the art; and statements inconsistent with the application.
- Reference. Belcher Pharmaceuticals v. Hospira, where the mechanism was simply that two departments did not speak.
[ ] Run it in both directions — alert regulatory affairs when an application makes a statement about the art.
[ ] Treat this as mandatory in life sciences and medical devices, where the regulatory file describes the same subject matter to a different audience in different words.

Phase 6. The company's own history

[ ] Ask the inventors for their publication list, including conference talks and posters.
[ ] Ask product management for prior products, catalogues, and installations in the relevant field.
[ ] Ask about prototypes shown at trade shows or to customers.
[ ] Ask about offers for sale, which are art under 35 U.S.C. § 102 regardless of confidentiality.
[ ] Remember the statute does not care who created the art.
- Reference. American Calcar v. American Honda Motor, where the applicant's detailed knowledge of its own system was disclosed only in part.

Phase 7. Automatic cross-citation

[ ] [Gate] Any reference cited in, or against, any family member is submitted in every pending member.
[ ] Make it a docketing action, not a decision.
- Why. The moment it becomes a judgment call it stops happening, and this is the most common genuine omission.
[ ] Define the family broadly — continuations, divisionals, continuations-in-part, and anything claiming common priority under 35 U.S.C. § 120.
[ ] Assign ownership where multiple firms prosecute, in the engagement letters.
[ ] Do not filter for cumulativeness here. Re-submitting a reference already of record costs almost nothing; the filtering decision is exactly the judgment that later has to be explained.
[ ] Log each submission against reference and application, so Phase 21 can be run.

Phase 8. IDS timing windows

[ ] Within three months of filing or before the first office action on the merits: no fee, no statement.
[ ] After that and before final action or allowance: fee or statement.
[ ] After final action or allowance and before the issue fee is paid: fee and statement.
[ ] [Gate] After the issue fee is paid: not considered. Diary the payment date as a candor deadline, and be prepared to withdraw from issue or file a continuation.
[ ] Know what the statement certifies — either first citation by a foreign office within three months, or that no bound individual knew of it more than three months earlier.
[ ] Reference: 37 C.F.R. § 1.97.

Phase 9. IDS content

[ ] A list separate from the specification, per 37 C.F.R. § 1.98.
[ ] Copies of non-US patent documents and non-patent literature.
[ ] A concise explanation of relevance for non-English documents, or an existing English-language search report.
[ ] [Gate] Do not characterize unnecessarily.
- Trap. A statement about what a reference teaches can become the alleged misrepresentation.
[ ] State in the transmittal that submission is not an admission of materiality or of prior art status.
[ ] Where a reference is genuinely central, do not let it disappear into a list of two thousand.

Phase 10. Disposition in writing

[ ] [Gate] Every reference considered and not submitted gets a one-line contemporaneous note.
- Why. Under Therasense v. Becton, Dickinson, deceptive intent must be the single most reasonable inference. Silence makes that inference available; a note forecloses it.
[ ] Record legitimate reasons specifically — cumulative of identified art of record; not prior art on the face of it with the date reasoning; submitted in an identified sibling application; queued and submitted late for a stated administrative reason.
[ ] Keep the note in the prosecution file, not an email thread. Assume it will be produced.
[ ] Do not write argument — no speculation about validity, no characterization of teaching.
[ ] Make the docket field mandatory, so a reference cannot be marked not-submitted without one.

Phase 11. The declaration protocol

[ ] [Gate] Read the underlying data personally. Not a summary, not a slide.
[ ] Disclose the declarant's relationship to the applicant — employment, consulting, equity.
- Reference. Ohio Willow Wood v. Alps South.
[ ] Check statements about the state of the art against what the declarant actually knows — the Aventis Pharma v. Hospira pattern.
[ ] For commercial success under 35 U.S.C. § 103, confirm the nexus to the claimed feature rather than to price, advertising, or an unclaimed feature.
[ ] [Gate] Obtain a separate written confirmation from the declarant that each statement is accurate.
[ ] Say the sentence. This is sworn, a hostile expert will read it line by line in ten years, and a statement known to be untrue makes the patent unenforceable regardless of the invention's merit.
[ ] Remember why this matters most. Affirmative egregious misconduct is material per se — no but-for showing required — which is where the surviving cases live.

Phase 12. Comparator and data selection

[ ] [Gate] Confirm the comparator is the closest prior art, and state why on the face of the declaration.
[ ] Disclose the full data set, or state the selection criteria expressly.
[ ] Identify any testing that produced unfavorable results and address it.
[ ] Confirm the testing protocol matches what the declaration says it was.
[ ] Have someone who did not prepare the declaration check it against the raw data.

Phase 13. When a problem is found

[ ] Confirm the facts first — what was known, by whom, when, and what the file shows.
[ ] [Gate] Assess materiality on the office's standard: but-for, on a preponderance, under the broadest reasonable interpretation.
- Trap. This is a different question from whether the reference invalidates in court on clear and convincing evidence. The two diverge in both directions, and conflating them is what produces non-disclosure in the first place.
[ ] Assess intent honestly. Is there a document showing consideration and rejection? Is there a structural explanation? A routing failure is a far better fact than a decision.
[ ] Fix pending applications immediately under 37 C.F.R. § 1.97, with the fee, without characterization.
[ ] Then move to Phase 14 for issued patents.

Phase 14. Supplemental examination

[ ] [Gate] Check availability first. 35 U.S.C. § 257 is unavailable for allegations already pleaded in a civil action, and restricted where the patent is asserted in specified pending proceedings.
[ ] Understand the immunizing effect — no unenforceability based on conduct relating to information considered, reconsidered, or corrected.
[ ] Expect ex parte reexamination under 35 U.S.C. § 302 if a substantial new question is raised.
[ ] Write the assessment memo: the information; the knowledge timeline; materiality answered rather than argued; intent exposure; survival analysis; timing and availability; collateral effects; and a named decision-maker.
[ ] [Gate] Do not wait for litigation. The cure is forfeited once the allegation is pleaded, and that forfeiture is the most common expensive mistake in this area.

Phase 15. Survival analysis

[ ] [Gate] Answer claim by claim: would the claims survive reexamination with this information of record?
[ ] Include the amendments that would be required.
[ ] Have it drafted by someone who did not prosecute the application.
- Why. An optimistic survival analysis makes the whole exercise worthless, because the office will reach its own view and the owner will have surfaced the problem with no cure.
[ ] Model the alternative — holding a patent with a latent unenforceability problem — and weigh it honestly against destroying the claims.
[ ] Consider reissue instead where narrowing is the goal and the candor issue is weak.
[ ] Consider intervening rights and any effect on a pending assertion or licence.

Phase 16. Legacy portfolio scoping

[ ] Do not audit everything. Cost is disproportionate and value is concentrated.
[ ] Rank by exposure: patents asserted or about to be; patents in a licensing programme; transaction-critical patents; and — the highest-yield category — patents whose prosecution overlapped with litigation on related technology.
[ ] Top tier: full reconstruction. What was known during pendency, from litigation files, foreign counsel files, regulatory files, and inventor publication records, checked against the file wrappers.
[ ] Second tier: the cheap query. Whether any reference cited against the company during the pendency window appears in the file wrapper.
[ ] The rest: document the decision not to audit, with the scoping rationale.
[ ] [Gate] Record the whole exercise. A contemporaneous record of a systematic good-faith review bears directly on intent; its absence is the silence that makes an adverse inference available.

Phase 17. Defending an allegation

[ ] [Gate] Move to dismiss on particularity under Exergen v. Wal-Mart Stores and Rule 9(b) — who, what, when, where, how.
[ ] Attack materiality on the correct standard, and explain the divergence between office and court tests to the judge.
[ ] Attack intent as not the single most reasonable inference, using disposition notes, sibling submissions, and docket records.
[ ] Separate the individuals. Aggregated corporate knowledge is not the test.
[ ] [Gate] Conduct the defense impeccably.
- Why. Regeneron Pharmaceuticals v. Merus shows litigation misconduct during the proceedings supplying the intent finding by adverse inference.
[ ] Map the consequences — unenforceability of all claims, potential infectious unenforceability across the family, fee shifting under 35 U.S.C. § 285, and antitrust exposure under 15 U.S.C. § 2 in egregious cases.
[ ] Note that unclean hands survives separately, on the Precision Instrument v. Automotive Maintenance line.

Phase 18. Privilege in the defense

[ ] Recognize the exposure. Defending frequently requires putting counsel's reasoning at issue, risking subject-matter waiver over prosecution communications.
[ ] Decide what will be relied on before relying on anything.
[ ] Map the prosecution communications that would fall within a likely waiver scope.
[ ] Assess the patent agent privilege position for agent communications.
[ ] Negotiate a clawback order early.
[ ] Write prosecution communications as if they will be produced, because in this scenario they will be. See the IP Privilege Protection Checklist.

Phase 19. Docketing configuration

[ ] Automatic cross-citation triggered when a reference is added to any family member.
[ ] A candor deadline on the issue fee payment date.
[ ] A five-day tickler for litigation art intake, with a named owner.
[ ] A foreign search report receipt event generating a domestic submission task.
[ ] A declaration checklist attached to any task involving a sworn statement.
[ ] [Gate] A mandatory disposition field that cannot be left blank when a reference is marked not submitted.
[ ] A scheduled annual audit task.

Phase 20. Sector patterns

[ ] Life sciences and medical devices. Regulatory review trigger mandatory; objective-indicia declarations are the dominant risk.
[ ] Software and electronics. Volume and multi-firm families; automatic cross-citation matters most; the company's own prior products are systematically underused as art.
[ ] Chemicals and materials. Comparative testing declarations dominate; the recurring defect is a comparator that is not the closest prior art.
[ ] Consumer and mechanical. Risk concentrates in the company's own history — previous models, catalogues, trade show showings.
[ ] University portfolios. Inventor publications are the dominant category; name publication explicitly in the briefing and ask for a publication list on the disclosure form.
[ ] Active licensing programmes. Audit before every assertion campaign, because a defendant reading the file wrapper against the litigation history is the likeliest discoverer — and by then § 257 may be foreclosed.

Phase 21. The annual test

[ ] [Gate] Pick one issued patent, ideally prosecuted while litigation was pending on related technology.
[ ] List every reference cited against the company in any forum during that patent's pendency.
[ ] Check each against the file wrapper.
[ ] Treat any reference neither submitted nor dispositioned as a finding, whether or not it was material.
[ ] Fix the mechanism, not the instance. A missed reference is a symptom; the routing rule that let it through is the problem.
[ ] Record the result and the remediation.

Phase 22. Reporting

[ ] Four audit numbers per patent examined: references known during pendency, submitted, dispositioned, and gaps.
[ ] Median days from litigation art receipt to prosecution counsel. Above ten means the rule exists only on paper.
[ ] Foreign search reports received and transferred, as a rate.
[ ] Regulatory submissions reviewed, as a proportion of those relating to products with pending applications.
[ ] Declarations filed, and the proportion with personal data review and separate declarant confirmation.
[ ] References not submitted with no disposition note. Target: zero. This is the number that becomes evidence.
[ ] Supplemental examination requests considered and filed, with outcomes.
[ ] One sentence of narrative: what changed in the risk profile, and what control is being added next.

Outcome. The reference was submitted immediately in the pending continuation under 37 C.F.R. § 1.97, with the fee and without characterization, and the claims were amended before issuance. For the parent, which had issued four months after litigation counsel received the chart, materiality was arguable and intent was weak — the failure was structural, the chart had sat in a litigation inbox, and no document showed anyone considering and rejecting submission. A request for supplemental examination was nonetheless filed under 35 U.S.C. § 257 before any allegation was pleaded; the office found a substantial new question, reexamination followed, and the claims emerged narrowed but intact, with the statutory bar on unenforceability then applying. The cost was reexamination fees, a narrowing amendment, and eight months, against a counterclaim that would have put the whole family at risk. The company then installed the five-day routing rule, the mandatory disposition field, and the annual test.

Phase 23. Model one-page briefing

Hand this to every person on the Phase 1 list. The citations are for the drafter; the version they receive has none.

You have a duty of candor to the Patent Office

You are named on a patent application, or you are substantively involved in preparing or prosecuting one. That gives you a personal legal duty of candor and good faith toward the Patent Office.

What the duty is. If you know of information that is material to whether the claims should be granted, it has to be disclosed. "Material" means the claims probably would not have been allowed if the examiner had known about it.

What the duty is not. You are not required to go looking for anything. You are not required to form a legal opinion about whether something matters. You are not required to explain or characterize anything.

How long it lasts. For as long as the application is pending.

What counts. Publications and patents you know of. Products, systems, or software sold, used publicly, or offered for sale before we filed — including our own. Papers or talks you or your colleagues gave. Prior art cited against us in any litigation, any Patent Office proceeding, or by any foreign patent office. Testing results bearing on what we told the Office.

The only instruction that matters. If you become aware of anything that might be relevant to whether these claims should issue, send it to [named contact]. Do not decide yourself. Sending something irrelevant costs a line on a form; not sending something that mattered can make the patent unenforceable.

If you are asked to sign a declaration. Read every sentence and confirm you personally know it to be true.

[ ] Drafting notes. Duty from 37 C.F.R. § 1.56; materiality tracks the but-for standard of Therasense v. Becton, Dickinson without asking a non-lawyer to apply it; the declaration paragraph exists because affirmative egregious misconduct is material per se.
[ ] Deliver it in person, once, for five minutes, and record the delivery.

Phase 24. Rewrite reference

Language that creates problems, and what to write instead.

| Written | Rewritten | |---|---| | Transmittal: "The cited reference does not disclose the claimed thermal isolation and is not material." | "Submission of these references is not an admission that they are prior art or that they are material." | | Disposition note: "Not relevant." | "Cumulative of US 7,123,456, already of record at IDS filed 3 March." | | Disposition note: (blank) | Any of the legitimate reasons in Phase 10, stated in one line. | | Declaration: "Surprisingly, the claimed compound outperformed the prior art." | "Compound A was compared against Compound B, which is the closest prior art because [reason]. The full data set is at Exhibit 1." | | Declaration: "Sales of the product have grown 400 percent." | Sales figures, plus the basis for attributing growth to the claimed feature rather than to price, advertising, or an unclaimed feature. | | Internal email: "We should probably not cite this one." | A disposition note in the file stating the actual reason, or a submission. | | Litigation counsel: "I'll hold this contention chart until we see if it goes anywhere." | Forward within five business days, logged. | | Engagement letter silent on routing | An express obligation to forward invalidity contentions, petitions, and prior art charts to prosecution counsel within five business days. |

[ ] Run every transmittal template and disposition field through this table.
[ ] Audit internal email conventions, since the intent element is proven from documents and the phrasing above is what a challenger quotes.

Phase 25. Evidence request, written in advance

Draft once so it can be sent unchanged when an allegation arrives or a diligence request lands.

[ ] Complete file wrapper for the patent and every family member, including all information disclosure statements and the examiner's initialed lists.
[ ] The bound-individual list for each application, with briefing delivery records.
[ ] Disposition records for every reference considered and not submitted.
[ ] Cross-citation log showing each reference and the family members it was submitted in.
[ ] Litigation art intake log — receipt date, source, forwarding date, disposition.
[ ] Foreign search reports received, with transfer dates and the three-month safe harbor calculation.
[ ] Regulatory submissions relating to the product, and the record of prosecution counsel's review.
[ ] Every declaration filed, with the underlying data, the comparator selection rationale, and the declarant's separate written confirmation.
[ ] Declarant relationship disclosures — employment, consulting, equity.
[ ] Inventor publication lists for the pendency period.
[ ] Prior product records — catalogues, installations, trade show materials, offers for sale.
[ ] Any supplemental examination request under 35 U.S.C. § 257, with the assessment memo and the outcome.
[ ] Prior audit memoranda, including scoping decisions about what was not audited.

Why this belongs in the checklist. Several of these do not exist at most companies, and the week an inequitable conduct counterclaim is pleaded is the worst time to discover that the disposition records were never kept — because their absence is precisely the silence that makes deceptive intent available as the single most reasonable inference under Therasense v. Becton, Dickinson.

Phase 26. Ninety-day installation

[ ] Days 1-5. Write the bound-individual list template and the one-page briefing.
[ ] Days 3-10. Install the five-day litigation routing rule. Name the owner. Amend the litigation engagement letters.
[ ] Days 8-20. Configure the docket: automatic cross-citation, mandatory disposition field, candor deadline on the issue fee date, foreign report receipt event.
[ ] Days 15-30. Establish the foreign search report transfer with a named owner per jurisdiction. Establish the regulatory review trigger.
[ ] Days 25-40. Brief every bound individual on every pending application. Record delivery.
[ ] Days 35-55. Adopt the declaration protocol and apply it to every pending declaration, including a re-check of comparator selection on declarations not yet acted on.
[ ] Days 50-80. Audit the top-tier legacy patents — asserted, licensing programme, transaction-critical, and prosecution overlapping litigation.
[ ] Days 70-85. Run Phase 13 and 14 on anything found, prioritizing pending applications over issued patents.
[ ] Days 85-90. Schedule the annual test. Report the baseline numbers.

What is deliberately deferred. The full legacy audit, which should be scoped by exposure rather than attempted comprehensively — and the decision not to audit the tail should itself be documented with its rationale.

Phase 27. Diligence, from both sides

[ ] As a buyer: compare the file wrapper against the litigation history. Whether references cited against the seller during a patent's pendency appear in its file is the single most productive query, and it needs no cooperation beyond document production.
[ ] As a buyer: ask for every declaration and its underlying data. The affirmative-misconduct route requires no materiality showing, so a declaration defect is a more serious finding than a missed reference.
[ ] As a buyer: ask whether supplemental examination has ever been requested, and if so, for the assessment memo and the outcome.
[ ] As a buyer: ask for disposition records. Their absence is itself informative about how the portfolio was managed.
[ ] As a seller: run the audit before the process begins.
- Why. The 35 U.S.C. § 257 cure is available now and will not be after a buyer's counsel writes the issue into a disclosure schedule. A cured problem is a better asset than an undiscovered one and materially better than a discovered and uncured one.
[ ] Price the finding rather than covenanting around it. An unenforceability risk is not a warranty item — the remedy for breach does not restore the asset, and infectious unenforceability means exposure is not confined to one patent.
[ ] Where a gap cannot be cured before closing, use a purchase price adjustment, an escrow tied to a post-closing supplemental examination, or an exclusion of the affected family.
[ ] [Gate] Disclose known issues in the schedule. The instinct to conceal is understandable and wrong: a buyer who discovers it later has a fraud claim, and the record of a cured problem is a defense rather than an admission.

Phase 28. Three things to say once

[ ] To the inventors, at the briefing. "You are not required to search, you are not required to form an opinion, and you are not required to explain anything. You are required to send it to me." That is the entire duty translated into an instruction a scientist can follow, and it is the version that produces compliance.
[ ] To litigation counsel, at the engagement. "Every invalidity contention comes to prosecution counsel within five business days. Submitting a reference is not an admission that it is prior art or material — the transmittal will say so — and the standard for candor materiality is not the standard for invalidity. This is a term, not a favor."
[ ] To the client, at the first review. "The risk is not that we forget a reference. It is that this company generates information in four places — regulatory files, litigation, foreign prosecution, and its own product history — and has no mechanism to move it to the person prosecuting the application. Every control here answers that structural fact, and none of them asks anyone to make a judgment under pressure."
[ ] Repeat the third one annually. It is the framing that keeps the programme funded, because it locates the risk in a system rather than in anyone's competence — which is both accurate and the reason people cooperate with it.

Phase 29. Quarterly dashboard

Six numbers, reported with the portfolio metrics rather than separately.

[ ] Median days from litigation art receipt to prosecution counsel. The best single measure of whether the highest-value control is working. Above ten means the rule exists only on paper.
[ ] References not submitted with no disposition note. Target: zero. This is the number that becomes evidence.
[ ] Foreign search reports received and transferred, as a rate, with any three-month safe harbor windows missed.
[ ] Declarations filed, and the proportion where underlying data was reviewed personally and the declarant separately confirmed accuracy in writing.
[ ] Bound individuals briefed, as a proportion of those named on applications filed in the quarter.
[ ] Regulatory submissions reviewed by prosecution counsel, as a proportion of those relating to products with pending applications.

And one annual composite: the results of the Phase 21 test — references known during pendency, submitted, dispositioned, and gaps — for the patent examined. That is the only number that measures the programme's actual output rather than its activity, and it is the one worth putting in front of whoever funds it.

Key Authorities at a Glance

| Authority | Proposition | |---|---| | 37 C.F.R. § 1.56 | Duty of candor; who is bound | | 37 C.F.R. § 1.97 | IDS timing, fees, statements, safe harbor | | 37 C.F.R. § 1.98 | IDS content requirements | | 35 U.S.C. § 257 | Supplemental examination; statutory cure | | 35 U.S.C. § 302 | Ex parte reexamination | | 35 U.S.C. § 282 | Defenses | | 35 U.S.C. § 285 | Exceptional case fee shifting | | 35 U.S.C. § 102 | Prior art, including the company's own | | 35 U.S.C. § 103 | Obviousness; objective indicia | | 35 U.S.C. § 115 | Inventor declarations | | 35 U.S.C. § 120 | Family scope for cross-citation | | Therasense v. Becton, Dickinson | But-for materiality; specific intent | | Kingsdown Medical Consultants v. Hollister | Gross negligence insufficient | | Exergen v. Wal-Mart Stores | Pleading particularity | | Aventis Pharma v. Hospira | Withheld art relied on by the applicant | | American Calcar v. American Honda Motor | Selective disclosure | | Regeneron Pharmaceuticals v. Merus | Litigation misconduct supplying intent | | Ohio Willow Wood v. Alps South | Undisclosed relationships | | Belcher Pharmaceuticals v. Hospira | Regulatory information | | Precision Instrument v. Automotive Maintenance | Unclean hands | | Keystone Driller v. General Excavator | Equitable origins | | Hazel-Atlas Glass v. Hartford-Empire | Fraud on the court | | Fed. R. Civ. P. 9 | Particularity | | 15 U.S.C. § 2 | Walker Process exposure |

The five things people get wrong

Treating cross-citation as a judgment call. A reference cited in one family member is known to the practitioner and must be considered for the others. The moment this becomes a decision rather than a docketing action it stops happening, and it is the most common genuine omission in practice.

Leaving litigation art in litigation counsel's inbox. Almost every modern unenforceability finding involves information the company already held for a different purpose. An invalidity contention chart is known prior art, and the five-day routing rule that fixes this costs nothing at all.

Considering a reference and submitting nothing, with no note. Under Therasense the challenger must show deceptive intent as the single most reasonable inference. Silence in the file is what makes that inference available; a one-line contemporaneous explanation forecloses it.

Confusing candor materiality with litigation invalidity. Materiality is but-for, on a preponderance, under the broadest reasonable interpretation the office applies. Invalidity is clear and convincing, under the court's construction. A reference can be material for candor and insufficient to invalidate — and the instinct to treat any acknowledgment of a reference as fatal everywhere is precisely what produces the non-disclosure.

Waiting for litigation before considering supplemental examination. 35 U.S.C. § 257 is unavailable once the allegation is pleaded. A patent owner who suspects a problem and does nothing has forfeited the only statutory cure available.