Section 112 Toolkit: Claim Support Charts, Invalidity Contentions, and Expert Declarations

How to use this toolkit

These papers are templates, and a template can be wrong for your facts. Each one tells you who should own it and when to use it, and the drafting notes explain which decision it serves. Bracketed text is a placeholder. Everything else is a starting draft to be conformed to your court's rules, your record, and your claims.

For the law behind them, read Enablement, Written Description, and Indefiniteness After Amgen v. Sanofi: What Section 112 Demands. For the sequence of decisions, read Drafting Patent Claims and Specifications That Survive Section 112: A Practical Guide. For a quick review pass, use the Section 112 Patent Review Checklist: A Practical Checklist.

Table of contents

1. Claim support chart
2. Priority chain chart
3. Wands factors worksheet
4. Common quality statement
5. Algorithm disclosure template
6. Section 112(f) parsing worksheet
7. Machine learning disclosure worksheet
8. Indefiniteness term audit and clause bank
9. Office action response shells and Rule 132 declaration
10. Decision matrix: which Section 112 ground fits
11. Pleading and invalidity contention language
12. Discovery requests and inventor deposition outline
13. Expert declaration outlines
14. Summary judgment, JMOL, and verdict form language

1. Claim support chart

Purpose: show, limitation by limitation, where the specification supports the claim and how far. Owner: prosecutor before filing; litigation associate plus technical expert before assertion or in response. Timing: before filing, before each amendment, and again before suit.

Filled sample row (hypothetical). Suppose Harrowgate Coatings claims a "marine coating comprising a biocide-free polymer that reduces barnacle settlement by at least 80% over 12 months."

Drafting notes.

• Quote. A chart that says "see generally" conceals the gap the chart exists to expose. The test is an objective reading of the four corners. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc).
• The "scope gap" column is the point of the exercise. The statement that the specification must enable the full scope, Amgen Inc. v. Sanofi, 598 U.S. 594, 610 (2023), means the review has to go to the edge of the claim.
• Be honest about ranges. Claims running past the disclosed data failed in Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023), and In re PEN, No. 23-2282 (Fed. Cir. June 12, 2024) (nonprecedential).
• Mark this chart as privileged when prepared for litigation. A candid support chart is sensitive work product, so limit circulation.

2. Priority chain chart

Purpose: establish the date each claim can actually claim. Owner: prosecutor, then litigation counsel. Timing: before filing any continuation or continuation-in-part, and before any pre-suit letter.

Then fill in the consequences:

Earliest date for claim [n]: [date]
Accused product's first public disclosure or sale: [date and source]
Other art between those dates: [list]
If the date is lost, is claim [n] anticipated by the accused product? [Y/N]
Who must carry what: challenger produces intervening art; patent owner then
   shows entitlement to the earlier date. Confirm allocation for your forum.
Inventors' statements on when they first had this limitation: [source]

Drafting notes.

• Each ancestor must support the claim as 35 U.S.C. § 120 and § 119(e) require. Lockwood v. American Airlines, Inc., 107 F.3d 1565 (Fed. Cir. 1997), holds that a disclosure making the claim obvious does not suffice.
• PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299 (Fed. Cir. 2008), is the usual source for how the burden moves once intervening art is shown.
• For a subgenus drawn from a long list, write the exact blaze marks into the last column. Seagen Inc. v. Daiichi Sankyo Co., No. 23-2424 (Fed. Cir. Dec. 2, 2025), applying In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967), lost a chain of more than a decade on this column. Note also Regents of the University of Minnesota v. Gilead Sciences, Inc., 61 F.4th 1350 (Fed. Cir. 2023), where the same reasoning arose in an IPR.
• For filing mechanics, see the Provisional Application Toolkit: Invention Capture Templates, Written Description Audits, and Conversion Calendars.

3. Wands factors worksheet

Purpose: a factor-by-factor enablement analysis for one claim, usable by either side. Owner: technical expert with counsel. Timing: before filing for a claim you plan to rely on; within 30 days of an enablement rejection; before serving contentions.

Patent/application: [no.]     Claim: [n]     Effective filing date: [date]
Construction assumed: [quote; note if disputed]
Outer boundary: "This claim covers every ____ that ____."

Embodiments at issue (name them):
  E1: [embodiment; why within the claim; source]
  E2: [ ]
  E3: [ ]

Conclusion: [ ] Enabled across E1 to E3   [ ] Not enabled for: ______
Is the required work routine adaptation, or a research assignment?
  Quote the best evidence on each side:
Common quality disclosed? [Y/N; cite]
If Y, does the record show that it correlates with function? [cite]

Drafting notes.

• Factor list: In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). It continues after Amgen, as Baxalta Inc. v. Genentech, Inc., 81 F.4th 1362 (Fed. Cir. 2023), holds, and the USPTO's guidelines at 89 Fed. Reg. 1563 (Jan. 10, 2024), confirm for examination.
• Name embodiments. McRO, Inc. v. Bandai Namco Games America Inc., 959 F.3d 1091 (Fed. Cir. 2020), reversed where the challenger left them abstract.
• The factors do not float free. Under Alcon Research Ltd. v. Barr Laboratories, Inc., 745 F.3d 1180 (Fed. Cir. 2014), a challenger must first show some experimentation is needed.
• Do not rest only on the cumulative time to make the whole genus. Amgen disclaims that measure.
• Factor 4 is where a method-of-use defense lives. Teva Pharmaceuticals International GmbH v. Eli Lilly & Co., No. 24-1094 (Fed. Cir. Apr. 16, 2026), rehearing en banc denied Sept. 30, 2026 (Dyk, J., dissenting).
• Factor 7 may carry admissions from any forum, and Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013), shows the combination of unpredictability and screening is hard to overcome.
• The answer under factor 8 should list any "or" branch that cannot work. Satius Holding, LLC v. Samsung Electronics Co., No. 25-1446 (Fed. Cir. Oct. 1, 2026). For inoperative embodiments generally, see Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569 (Fed. Cir. 1984).

4. Common quality statement

Purpose: a specification section that states a rule identifying class members, the disclosure that distinguishes the Amgen claims. Owner: prosecutor with inventors. Timing: at drafting. Use it only if the data support it.

[SECTION HEADING: Selection of [class members]]

The inventors determined that [feature], measured by [test method],
identifies [class members] having [function]. In the experiments reported
in Table [n], [x] candidates were selected to span [structural or design
variable]. Of those having [feature] in the range [r1] to [r2], [y of z]
exhibited [function] at or above [threshold]. Of those outside the range,
[y' of z'] did so.

A person of ordinary skill can apply this selection rule by [simple,
named measurement], which does not require [testing for the ultimate
function]. Candidates identified in this way are expected to exhibit
[function] because [mechanism or reason, stated as understanding at
filing, without being bound by theory].

The exceptions observed were [describe], which are attributed to
[reason] and are excluded by [dependent limitation or stated condition].

Drafting notes.

• This is the opening left by Incandescent Lamp and Amgen: a few examples may suffice if the specification discloses "some general quality" running through the class. Amgen, 598 U.S. at 611.
• Baxalta's patent failed because it disclosed no such feature and did not explain why its antibodies worked. The statement above answers that charge directly.
• Test before you assert. In the nonprecedential Pioneer Hi-Bred International, Inc. v. Inari Agriculture, Inc., No. 25-1287 (Fed. Cir. Oct. 2, 2026), later data contradicted an expert's prediction that structure correlated with function, and post-filing evidence was properly considered.
• Do not overstate correlation. A false or careless statement about results is a candor issue under 37 C.F.R. § 1.56, in 37 C.F.R. Part 1.

5. Algorithm disclosure template

Purpose: capture what a software engineer actually built, in a form that supplies structure under § 112(f), and enablement and written description under § 112(a). Owner: lead engineer completes; prosecutor edits. Timing: at invention capture, one sheet for every claimed function.

FUNCTION SHEET [n]
Claimed function (quote from draft claim): ______________________

Inputs:
  Name, type, source, valid range: _______________________________
Outputs:
  Name, type, destination, range: ________________________________
Preconditions and state read or written: _______________________

Transformation, step by step (prose or pseudo-code):
  1. __________________________________________________
  2. __________________________________________________
  3. __________________________________________________

Key data structures (schema, dimensions, indexes): ______________
Formula(s), with every variable defined: _________________________
Thresholds and how they are set: _________________________________
Components that perform each step, and how they interact: _______
Why this works, and what it improves (latency, memory, accuracy),
  with measured results and test conditions: ______________________

Alternatives actually considered:
  A. [approach] worked / failed because _________________________
  B. [approach] worked / failed because _________________________
Alternative implementations we can teach (with what changes): ___

Third-party components relied on (name, version, role): __________
Figure to accompany this sheet: [flow chart no.]
Best mode known at filing: ______________________________________

Filled sample excerpt (hypothetical). Pellwood Sensors detects bearing wear from vibration on low-power hardware.

Claimed function: "determine a wear state from the vibration samples"
Inputs: 1,024 accelerometer samples at 3.2 kHz, 16-bit, ring buffer
Output: wear state in {0,1,2} written to register 0x14
Transformation:
  1. Apply Hann window and 1,024-point fixed-point FFT.
  2. Sum magnitude in bands B1 (120 to 180 Hz) and B2 (480 to 620 Hz).
  3. Compute r = B2/B1. Update exponential moving average m with
     alpha = 0.05.
  4. Output 0 if m < 0.4; 1 if 0.4 <= m < 0.9; 2 otherwise.
Why: step 3 eliminates load-dependent amplitude, so no calibration
  run is required; 11 uW average draw measured on [hardware].

Drafting notes.

• Inputs, outputs, and how the first becomes the second. A corresponding algorithm is required for computer-implemented means-plus-function terms, Gramm v. Deere & Co., No. 24-1598 (Fed. Cir. Mar. 11, 2026), restating WMS Gaming Inc. v. International Game Technology, 184 F.3d 1339 (Fed. Cir. 1999), and Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 521 F.3d 1328 (Fed. Cir. 2008).
• Any understandable form is fine. Gramm notes in a footnote that an algorithm need not be in code, citing Typhoon Touch Technologies, Inc. v. Dell, Inc., 659 F.3d 1376 (Fed. Cir. 2011).
• Black-box language fails. Blackboard, Inc. v. Desire2Learn, Inc., 574 F.3d 1371 (Fed. Cir. 2009); Noah Systems, Inc. v. Intuit Inc., 675 F.3d 1302 (Fed. Cir. 2012).
• The "why" line supports both a technical improvement argument under 35 U.S.C. § 101 and the Wands direction factor. The Section 101 Toolkit: Claim Drafting, Motions to Dismiss, and Expert Support uses the same facts.
• "Alternatives we can teach" is the guard against LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005), and Sitrick v. Dreamworks, LLC, 516 F.3d 993 (Fed. Cir. 2008). Leave it blank rather than making something up, and then do not claim beyond it.
• Commercial component references can provide structure only if a skilled person would understand them. Budde v. Harley-Davidson, Inc., 250 F.3d 1369 (Fed. Cir. 2001); Gramm.

6. Section 112(f) parsing worksheet

Purpose: decide whether a limitation without "means" is a means-plus-function term, from either side. Owner: counsel with a technical expert. Timing: at drafting; before the joint claim construction statement.

Limitation (full quote): _____________________________________
Uses "means"? [ ] yes (presumption for 112(f)) [ ] no (presumption against)
Parse:
  Non-function term (who/what performs): _______________________
  Claimed function(s): __________________________________________
How general is the function? [ ] specific operation [ ] user-desired result
Does the claim state how? inputs ___ outputs ___ connections ___ operation ___
Does the specification give the term a structural meaning? [cite]
Field usage at filing:
  Publications and dictionaries: ______________________________
  Products or off-the-shelf code performing the function: _____
  Expert statement: ____________________________________________
Who has the burden here: _______   Evidence needed: ___________

If 112(f) applies:
  Step 1, function: _____________
  Step 2, corresponding structure clearly linked: ____________
  Algorithm for each function? [cite]  Whole function covered? [Y/N]
  Katz exception credible? (only generic processing/receiving/storing)
Assessment: [ ] Not 112(f) [ ] 112(f), definite [ ] 112(f), indefinite
If not 112(f): run Worksheet 3 across every way of performing the function.

Drafting notes.

• The questions come from TrackTime, LLC v. Amazon.com Services LLC, No. 24-1102 (Fed. Cir. July 2, 2026), which requires identifying the function, looking at its generality, and considering what relevant artisans understood, and which places the burden on the proponent of the means-plus-function construction.
• Standard: Williamson v. Citrix Online, LLC, 792 F.3d 1339 (Fed. Cir. 2015).
• Compare results: not § 112(f) in Dyfan, LLC v. Target Corp., 28 F.4th 1360 (Fed. Cir. 2022), Zeroclick, LLC v. Apple Inc., 891 F.3d 1003 (Fed. Cir. 2018), and Apple Inc. v. Motorola, Inc., 757 F.3d 1286 (Fed. Cir. 2014); § 112(f) in Rain Computing, Inc. v. Samsung Electronics Co., 989 F.3d 1002 (Fed. Cir. 2021), Fintiv, Inc. v. PayPal Holdings, Inc., 134 F.4th 1377 (Fed. Cir. 2025), Egenera, Inc. v. Cisco Systems, Inc., 972 F.3d 1367 (Fed. Cir. 2020), and Robert Bosch, LLC v. Snap-On Inc., 769 F.3d 1094 (Fed. Cir. 2014).
• Katz: In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011), limited by EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616 (Fed. Cir. 2015).
• In examination, compare the three-prong test in 84 Fed. Reg. 57 (Jan. 7, 2019), and MPEP Section 2181.

7. Machine learning disclosure worksheet

Purpose: capture what will matter when a trained-model claim is tested. No precedential decision we found yet applies Amgen directly to such a claim, so this reflects a cautious reading. Owner: ML lead with prosecutor. Timing: at invention capture.

Drafting notes.

• A claim to any model reaching a metric has the shape of Brita LP v. International Trade Commission, No. 24-1098 (Fed. Cir. Oct. 15, 2025), and Juno. Add structural rungs.
• Applying generic machine learning to a new data environment does not solve eligibility: Recentive Analytics, Inc. v. Fox Corp., 134 F.4th 1205 (Fed. Cir. 2025). The Patent Office's precedential Ex parte Desjardins, Appeal No. 2024-000567 (ARP 2025), points examiners to Section 112 as the proper limit on scope, so expect the question.
• Consider what you are ready to disclose. A trained weight file is not usually necessary, but a description that keeps the critical step secret risks both enablement and best mode problems. Ownership questions are addressed in AI-Generated Inventions: Who Owns What the Machine Creates?.

8. Indefiniteness term audit and clause bank

Purpose: find and fix or attack words without objective boundaries. Owner: prosecutor before filing; claim construction team in litigation. Timing: at drafting; after allowance; at the claim construction exchange.

Screening search (adapt to your field):

about | approximately | substantially | essentially | generally | roughly
sufficient | effective | suitable | adequate | high | low | thin | near
significantly | improved | better | similar | unobtrusive | negligible
non-exhaustive | real-time | lightweight | any marketing adjective

Clause bank.

Tolerance definition:

As used in this application, "approximately," when applied to a temperature, means within plus or minus [2] degrees Celsius of the stated value, measured [method].

Measurement method:

Unless stated otherwise, [property] is determined by [standard or protocol], using [conditions, instrument, sample preparation, and time point]. Where methods would give different values, the value obtained by this method controls for purposes of the claims.

Comparator for a relative term:

A coating is "more durable" than a reference when, under Test [C], it retains at least [x]% more gloss than the reference coating of Example 1 after [n] cycles.

Result term with a threshold:

"Real time," as used here, means that an output is produced within [n] milliseconds of receipt of the corresponding input under the load described in Example [k].

Non-limiting examples versus definitions:

The term "[coined term]" means [definition]. Examples include [a], [b], and [c]; other examples are within the term if they satisfy the definition.

Drafting notes.

• Standard: Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014).
• Measurement cases: Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015); Dow Chemical Co. v. Nova Chemicals Corp., 803 F.3d 620 (Fed. Cir. 2015); HZNP Medicines LLC v. Actavis Laboratories UT, Inc., 940 F.3d 680 (Fed. Cir. 2019).
• Approximation: Enviro Tech Chemical Services, Inc. v. Safe Foods Corp., No. 24-2160 (Fed. Cir. May 4, 2026), against Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd., 476 F.3d 1321 (Fed. Cir. 2007).
• Subjective anchors: Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364 (Fed. Cir. 2014); Sonix Technology Co. v. Publications International, Ltd., 844 F.3d 1370 (Fed. Cir. 2017); Niazi Licensing Corp. v. St. Jude Medical S.C., Inc., 30 F.4th 1339 (Fed. Cir. 2022).
• Functional terms are not per se indefinite: BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360 (Fed. Cir. 2017); Nevro Corp. v. Boston Scientific Corp., 955 F.3d 35 (Fed. Cir. 2020).
• A term added to overcome art draws special attention, as in the nonprecedential Network-1 Technologies, Inc. v. Google LLC, No. 24-1893 (Fed. Cir. Apr. 23, 2026). Choose the tolerance with the closest art in mind, because the definition will bind you.

9. Office action response shells and Rule 132 declaration

Purpose: answer Section 112 rejections without creating new problems. Owner: prosecutor. Timing: on receipt of the action; inside the response period.

Enablement shell.

The rejection of claims [n] under 35 U.S.C. 112(a) should be withdrawn.
The Office bears the initial burden of explaining why the full scope of
the claims is not enabled, with reference to the Wands factors. See 89
Fed. Reg. 1563 (Jan. 10, 2024).

[For each factor the rejection relies on:]
Factor [ ]: The Office Action states [quote]. The specification, at
[cite], teaches [ ]. Dr. [Name] explains at paragraph [ ] of the
accompanying declaration that [fact]. The claim is limited by [feature],
and so a skilled artisan is not left to screen [the class] for [function].

Unlike the roadmap in Amgen, the specification here identifies a [feature]
common to the claimed [class], at [cite], with supporting data at [cite].

Written description shell.

Claim [n] recites [limitation]. Support is found at [para.], which states
[quote], at FIG. [ ], and in Example [ ]. A person of ordinary skill reading
those passages together would recognize that the inventors had [limitation]
as of the filing date, because [reason tied to the text]. [Dr. Name, ¶ ].

Definiteness shell.

"[Term]" is defined at [para.] as [quote]. Applying that definition, a person
of ordinary skill can determine whether [ ] by [method]. To remove any doubt,
and without acquiescing in the rejection, Applicant amends claim [n] to recite
[ ].

Rule 132 declaration outline (under 37 C.F.R. § 1.132, in 37 C.F.R. Part 1):

1. Qualifications and materials reviewed; compensation and relationship disclosed.
2. Level of skill at the filing date, and the basis for that view.
3. What was known and routine at filing, with citations.
4. What the specification teaches, with paragraph references, and how a skilled person would use it.
5. Any test results (who ran them, how, on what, and all results, not only the good ones).
6. Why the required work is adaptation and not a search, tied to Wands factors.
7. The declaration language of 37 C.F.R. § 1.68, with its 18 U.S.C. § 1001 acknowledgment.

Drafting notes.

• Answer the actual rejection, and argue every point. In In re PEN, new arguments on appeal were forfeited. In In re Starrett, No. 22-2209 (Fed. Cir. June 8, 2023) (nonprecedential), conclusory responses failed, and a failure to argue claims separately let the Board select a representative claim.
• The Office may reject unclear language under In re Packard, 751 F.3d 1307 (Fed. Cir. 2014). A clarifying amendment may cost you little now, compared with what the same dispute costs in court.
• If an amendment narrows, assess estoppel and whether the amended claim still reads on what you need.
• Watch for statements inconsistent with what you argue under § 103. Infinity Computer Products, Inc. v. Oki Data Americas, Inc., 987 F.3d 1053 (Fed. Cir. 2021).
• More general response templates appear in the Patent Prosecution Toolkit: A Roadmap and Research Guide.

10. Decision matrix: which Section 112 ground fits

Purpose: pick the ground that fits the facts, and avoid arguing them all equally. Owner: lead litigation counsel. Timing: first case assessment; before contentions.

Drafting notes.

• Authorities in this table not linked in the earlier papers: Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371 (Fed. Cir. 2007), Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998), ICU Medical, Inc. v. Alaris Medical Systems, Inc., 558 F.3d 1368 (Fed. Cir. 2009), ALZA Corp. v. Andrx Pharmaceuticals, LLC, 603 F.3d 935 (Fed. Cir. 2010), Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149 (Fed. Cir. 2019), Wyeth LLC v. AstraZeneca Pharmaceuticals LP, No. 24-2325 (Fed. Cir. July 9, 2026), Ajinomoto Co. v. International Trade Commission, 932 F.3d 1342 (Fed. Cir. 2019), In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025), and In re Hogan, 559 F.2d 595 (C.C.P.A. 1977). The impossibility discussion is in the nonprecedential Indect USA Corp. v. Park Assist, LLC, No. 24-1023 (Fed. Cir. Jan. 7, 2026).
• Forum: inter partes review cannot directly raise these grounds. 35 U.S.C. § 311(b). Post-grant review can, 35 U.S.C. § 321(b), on a preponderance, 35 U.S.C. § 326(e).

11. Pleading and invalidity contention language

Purpose: preserve and give notice of Section 112 grounds with enough specificity to survive challenge. Owner: litigation counsel. Timing: answer; invalidity contentions; supplementation as construction issues resolve.

Affirmative defense and counterclaim (see Fed. R. Civ. P. 8(c), Rule 13, and Rule 11):

The asserted claims of the '[ ] Patent are invalid for failure to comply
with 35 U.S.C. § 112, including because, as Plaintiff appears to construe
them: (a) claim [n] covers [class], yet the specification discloses only
[examples] and offers no [feature] by which a skilled person could identify
[class] without [what is required]; (b) the [earliest] application does not
describe [limitation], so claim [n] is not entitled to a date before [date];
and (c) the term "[term]" fails to inform those skilled in the art of the
scope of the claim with reasonable certainty because [specific reason].

Enablement contention.

If construed to cover [Defendant's product or other named embodiment], claim
[n] is invalid under § 112(a) for lack of enablement.

Scope. As Plaintiff reads it, claim [n] covers [every ____ that ____].
This includes at least (i) [embodiment 1], (ii) [embodiment 2], and (iii)
[embodiment 3], each of which [falls within the claim because ___].

Disclosure. The specification discloses [number] examples, each of [type]
([cite]). For other embodiments, it says only [quote]. It does not identify
any quality common to [class] that would allow a skilled person to determine
which [candidates] have [function] without making and testing them.

Experimentation. To make and use [embodiment 1] as of [date], a skilled
person would have had to [steps]. [Source] reports that [hit rate or
failure]. The nature of the art, including [cite], made results unpredictable.

Wands factors. [Short statement per factor, tied to the above.]

Authority. Amgen Inc. v. Sanofi, 598 U.S. 594 (2023); Baxalta Inc. v.
Genentech, Inc., 81 F.4th 1362 (Fed. Cir. 2023); McRO, Inc. v. Bandai Namco
Games Am. Inc., 959 F.3d 1091 (Fed. Cir. 2020).

Written description and priority contention.

Claim [n] lacks written description support [in the application as filed]
[in the [date] application]. It recites [limitation]. The cited text
discloses instead [quote], which encompasses [number or broad class] of
alternatives, with no [blaze marks] directing a skilled reader to [the
claimed subset]. [Named inventor] testified that [quote, page:line]. The
claim is entitled to a date no earlier than [date]. [Reference] therefore
qualifies as prior art and anticipates claim [n] as shown in [Exhibit].

Indefiniteness contention.

"[Term]" is indefinite under § 112(b). The specification [does not define it]
[uses it inconsistently at ___ and ___]. [Measurement A] and [Measurement B]
are both reasonable in the art and give different results [cite]. During
prosecution, Applicant stated [quote] and later [quote], which do not resolve
the question. A skilled person would not know with reasonable certainty
whether [specific example] falls within the claim.

Section 112(f) contention.

"[Limitation]" is governed by § 112(f). Defendant will show that, as used
in the claim, "[noun]" does not have a sufficiently definite meaning as the
name for structure for performing [function]. [Short field-usage evidence.]
The specification discloses no corresponding algorithm: the passages Plaintiff
may cite ([cite]) restate the function or name a general-purpose computer.
The claim is therefore indefinite under § 112(b). In the alternative, if
§ 112(f) does not apply, claim [n] is not enabled or described across
the full scope of ways of performing [function].

Drafting notes.

• Local patent rules vary. N.D. Cal. Patent L.R. 3-3 and E.D. Tex. P.R. 3-3 are well-known models requiring § 112 grounds. Check yours, and move to supplement after claim construction where the rules allow.
• "As Plaintiff appears to construe" protects your noninfringement position. Keep it in every paragraph.
• The contention's specificity is required by McRO and helpful under the JMOL standard, since a challenger's clear and convincing burden applies, Microsoft Corp. v. i4i Ltd. Partnership, 564 U.S. 91 (2011); 35 U.S.C. § 282.
• Prior art work goes with the Prior Art Toolkit: Search Protocols, Invalidity Charts, and On-Sale Bar Investigations.

12. Discovery requests and inventor deposition outline

Purpose: get the record that has decided recent cases. Owner: litigation team. Timing: after contentions and early in fact discovery.

Requests for production (Rule 34):

1. All documents concerning any attempt before [filing date] to make or use
   [claimed class], including attempts that failed.
2. All data concerning the [function] of any [member] made or tested by or
   for Plaintiff or any named inventor, before or after [filing date].
3. All documents concerning why any [candidate] did or did not exhibit
   [function], including any structure-function analysis.
4. Publications, presentations, and grant applications by any named inventor
   concerning [subject matter].
5. Documents sufficient to show when Plaintiff first learned of [accused
   feature] and the drafting of claims [n] (subject to privilege).
6. Statements by Plaintiff to any government agency, investor, or licensee
   about the predictability or difficulty of [subject matter].

Interrogatory (Rule 33):

For each asserted claim, identify the earliest priority date You contend it
is entitled to, and for each limitation identify by page and line the text
in each priority document on which You rely.

Inventor deposition outline (Rule 30). For conduct issues, keep the Deposition Conduct Toolkit: Objection Scripts, Record-Making Language, and Rule 30(d) Motions nearby.

1. Background and role. Who did which experiments? Who wrote what?
2. Walk through each example. Who performed it? When? Was it actually run?
3. What else was tried? How many? How many failed? Why?
4. By the filing date, had you made [embodiment]? Had you thought of it? Show me where the application says so.
5. When did you first see [accused feature]? In what document?
6. Did you read the [later-filed] claims before filing? Did you recognize [limitation] from your earlier work?
7. Do you know why [the examples] work? Did you know then?
8. Your later publications: what do they say about [limits, toxicity, failure, new technology]?
9. Were you able, or was anyone in your group able, to make [alternative]? What happened?

Drafting notes.

• Inventor testimony cannot create a description, but it can show the lack of one. Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc., 923 F.3d 1368 (Fed. Cir. 2019), Seagen, and Brita all use it that way. In Wyeth, a co-inventor's testimony and a later paper established the in vitro to patient gap.
• Requests about post-filing work are proper for embodiments that could have existed at filing: Amgen Inc. v. Sanofi, Aventisub LLC, 872 F.3d 1367 (Fed. Cir. 2017). They do not reach technology that arose later. Entresto; Hogan.
• Defending? Inventors should reread the application and know the difference between what they knew at filing and what they know now. Preparation is allowed; scripting is a different thing. The expert discovery rules are in Rule 26.

13. Expert declaration outlines

Purpose: frame technical testimony for the three recurring Section 112 fights. Owner: counsel and retained expert. Timing: per the scheduling order; indefiniteness declarations typically with claim construction.

A. Challenger's enablement or written description report

1. Assignment, qualifications, compensation, materials (Rule 26(a)(2)(B)).
2. Legal standards supplied by counsel: clear and convincing evidence; Wands; full scope; for written description, Ariad.
3. Person of ordinary skill and the date.
4. Technology background.
5. The claim as construed, with both parties' constructions if disputed.
6. Size and nature of the claimed class, with method of counting and assumptions.
7. What the specification discloses, by example, and what it does not.
8. Named embodiments within the claim, and why.
9. Each Wands factor, with evidence: work needed for each embodiment, likely failure rate, and citations for unpredictability.
10. Common quality analysis: Does the specification identify one? Does the data correlate?
11. Written description: four corners; representative species; common structural features; blaze marks.
12. Response to the anticipated patent owner positions.

B. Patent owner's rebuttal report

1. Assignment, qualifications, materials.
2. Burden stated correctly.
3. What the invention is: new use, combination, improvement, or new class, and why it matters.
4. State of the art at filing, with sources, including the challenger's own statements.
5. What a skilled person understood from the specification, paragraph by paragraph.
6. Why identified embodiments can be made with reasonable effort, addressing each Wands factor. Use actual numbers.
7. The common quality or the well-known class, with data.
8. Rebuttal of the challenger's counts and failure rates.
9. For post-filing evidence: is it about embodiments that existed, or later-arising technology?

C. Indefiniteness or Section 112(f) declaration for claim construction

1. Assignment, qualifications, materials.
2. The term, and the parties' proposals.
3. How the term was used in the field at filing, with dated sources.
4. Intrinsic record, as a skilled reader would understand it.
5. For measurement: available methods, whether they give different results (with data), and whether the patent selects one.
6. For degree: whether a skilled person could apply the term to specific examples (give some near the line).
7. For § 112(f): whether the words name a known structure or class; available off-the-shelf products or code at the time, by name and date; and what the claim says about operation.
8. If § 112(f) applies: what the specification discloses as an algorithm, step by step, and whether it performs the whole function.

Drafting notes.

• Rule 702 governs admissibility, as amended in 2023. Fed. R. Evid. 702; see Expert Witnesses After the 2023 Amendment to Rule 702: Daubert, Disclosure, and Cross-Examination and the Expert Deposition Toolkit: Outline Frameworks, Reliance Material Requests, and Rule 26 Protection Maps.
• Avoid "leap," "could figure out," and "would have been obvious to." The Seagen panel used such testimony against the party that offered it, and Ariad says rendering obvious is not describing.
• Conclusory meaning testimony gets little weight: Satius footnote 1. On the other side, unrebutted technical testimony can decide § 112(f), as in Dyfan. Rebut in writing.
• Under Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. 318 (2015), a district court's findings on this evidence get clear-error review, so offer evidence that a court can actually make findings on. TrackTime faulted a ruling that mentioned the experts only in passing.
• The artisan at the claim construction stage is the one on the application date. Nautilus focuses on filing-time understanding, and Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374 (Fed. Cir. 2015), shows how evidence from skilled artisans can carry the point. Materials for that stage are in the Claim Construction Toolkit: Charts, Briefs, Expert Declarations, and Hearing Materials.

14. Summary judgment, JMOL, and verdict form language

Purpose: preserve Section 112 grounds through judgment. Owner: trial team. Timing: dispositive motion deadline; close of the opposing party's evidence; within 28 days after judgment for renewal.

Summary judgment statement of undisputed facts (Rule 56), adapted to an Amgen-type case:

1. Claim [n] covers all [class] that [function(s)].
2. The specification discloses the structure of [number] [members].
3. Plaintiff's experts agree that the only way to identify other [members]
   is to [make and test]. [Cite.]
4. The specification identifies no feature common to [members] that
   distinguishes them from [non-members]. [Cite.]
5. The class includes at least [number] candidates. [Cite.]

Rule 50(a) motion (Rule 50):

Defendant moves under Rule 50(a) for judgment as a matter of law that claims
[n] are invalid for lack of enablement because no reasonable jury could find
that the specification teaches a skilled person to make and use the full scope
of the claims without undue experimentation; specifically, [claim scope],
[evidence on hit rate, guidance, examples], and [admissions]. Defendant
further moves for judgment that claims [n] lack written description support
[in the [date] application] because [specific reason].

Patent owner's response theme, on JMOL:

The burden was clear and convincing evidence. Viewing the evidence in the light
most favorable to the verdict, a reasonable jury could have found [fact], [fact],
and [fact], including through Defendant's own statements at [cite]. Each factual
finding supporting the verdict is treated as made if supported by substantial
evidence. Under those findings, [claim] is enabled and described.

Special verdict or interrogatory questions (Rule 49):

Q1. Has Defendant proven by clear and convincing evidence that claim [n] lacks
    a written description of the invention [in the [date] application]?
Q2. Has Defendant proven by clear and convincing evidence that a person of
    ordinary skill could not make and use the full scope of claim [n] without
    undue experimentation as of [date]?
Q3. [If used] For each Wands factor in dispute, state your finding: ______

Drafting notes.

• Timing: a renewed motion under Rule 50(b) is due within 28 days of judgment, and a ground not raised under Rule 50(a) generally cannot be renewed. Fed. R. Civ. P. 50.
• Enablement is a question of law on factual underpinnings; written description is a question of fact. Instruct and frame accordingly, and preserve objections under Rule 51.
• JMOL went for the challenger in Wyeth, Seagen, and Juno, and against the challenger in Teva. The patent owner's theme above draws on Teva's treatment of jury findings. Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330 (Fed. Cir. 2021).
• The statement of facts above follows Baxalta, where experts agreed the only way to identify a new embodiment was to make and test antibodies. Do not use it if your record lacks that agreement.
• Wider litigation materials are in the Patent Litigation Toolkit: A Roadmap and Research Guide. If jurisdiction or venue is in question, consult the Federal Jurisdiction Toolkit: Notices of Removal, Remand Motions, and Jurisdictional Allegations.

These templates are general information and not legal advice for a specific situation. Conform them to your facts and your court's rules.

Related Documents

Related Articles

• Enablement, Written Description, and Indefiniteness After Amgen v. Sanofi: What Section 112 Demands: the case readings these papers apply.
• Claim Construction and Markman Hearings: How Courts Decide What a Patent Actually Covers: when these papers meet the construction schedule.

Related Guides

• Drafting Patent Claims and Specifications That Survive Section 112: A Practical Guide: when and why to use each paper.
• Preparing for a Markman Hearing: A Practical Guide: using Papers 6, 8, and 13 at the hearing.

Related Checklists

• Section 112 Patent Review Checklist: A Practical Checklist: the review pass that tells you which paper you need.

Related Toolkits

• Claim Construction Toolkit: Charts, Briefs, Expert Declarations, and Hearing Materials: joint statements, briefs, and hearing materials.
• Provisional Application Toolkit: Invention Capture Templates, Written Description Audits, and Conversion Calendars: invention capture at the first filing.
• Prior Art Toolkit: Search Protocols, Invalidity Charts, and On-Sale Bar Investigations: search protocols and invalidity charts.
• Patent Prosecution Toolkit: A Roadmap and Research Guide: wider prosecution practice.
• Section 101 Toolkit: Claim Drafting, Motions to Dismiss, and Expert Support: eligibility support that shares the same technical facts.
• Deposition Conduct Toolkit: Objection Scripts, Record-Making Language, and Rule 30(d) Motions: objection scripts for inventor depositions.
• Federal Jurisdiction Toolkit: Notices of Removal, Remand Motions, and Jurisdictional Allegations: jurisdictional allegations and removal papers.
• Expert Deposition Toolkit: Outline Frameworks, Reliance Material Requests, and Rule 26 Protection Maps: frameworks for the experts these declarations support.