Written Description (Sec. 112(1/a))

  • BASICS: “The specification shall contain a written description of the invention, ….” 35 U.S.C. § 112(1/a). To support a claim, a Spec. must describe the claimed subject matter. “The hallmark of written description is disclosure. Thus, ‘possession as shown in the disclosure’ is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed. This inquiry, as we have long held, is a question of fact.” Ariad Pharm. (Fed. Cir. 03/22/10) (en banc); AbbVie (Fed. Cir. 07/01/14) (“Whether a patent claim is supported by an adequate written description is a question of fact, and we review a jury’s factual determination relating to compliance with the written description requirement for substantial evidence.”); see generally Amgen (Sanofi) I (Fed. Cir. 10/05/17) (remanding for new trial on written description and enablement, for improper jury instruction and exclusion of challenger’s evidence); Novartis (Fed. Cir. 06/21/22) (2-1) (rev’g D. Ct. finding of no written description invalidity: “Disclosure is essential; it is ‘the quid pro quo of the right to exclude.’”); Neology (Fed. Cir. 04/19/19) (non-precedential) (aff’g ITC finding claims lack written description support, in part for failing to describe exchange of security keys); Transperfect (Fed. Cir. 07/12/17) (non-precedential) (aff’g PTAB CBM finding of no written description support for claims; PTAB “correctly found that a person of ordinary skill in the art would not have understood that the inventors … possessed and described a plug-in that could perform a translation without using replacement hyperlinks.”); Cisco (Fed. Cir. 05/10/17) (rev’g PTAB finding of sufficient written description for claims attempted to be added in reexamination; Spec. did not “meet the quid pro quo required by the written description requirement” because the feature claimed was “a technically difficult solution that the [Spec.] does not solve, let alone contemplate or suggest as a goal or desired result.”). “The written description requirement requires possession as shown in the specification, not as shown by prior experimental work.” Allergan (Fed. Cir. 08/04/15) (sufficient written description in Spec.) “The scope of Centocor’s right to exclude cannot ‘over-reach the scope of [its] contribution to the field of art as described in the patent specification.’” Centocor (Fed. Cir. 02/23/11). This validity requirement also is an effective-filing date requirement under 35 U.S.C. § 120 (see below). Cited in PowerOasis (Fed. Cir. 04/11/08): Janice M. Mueller, Patent Misuse Through the Capture of Industry Standards, 17 Berkeley Tech. L.J. 623, 638 (2002) (“The [written description] requirement operates as a timing mechanism to ensure fair play in the presentation of claims after the original filing date and to guard against manipulation of that process by the patent applicant.”). “The statutory mandate for a written description as a prerequisite for patenting an invention has been a fixture of our laws for more than two centuries.” Biogen (Fed. Cir. 11/30/21) (2-1) (aff’g judgment of no written description; “The written-description requirement limits patent protection only to individuals who perform the difficult work of producing a complete and final invention featuring all its claimed limitations and publicly disclose the fruits of that effort.”).
  • Written Description Requirement Analogous To “Blaze Marks,” When Broad Genus Disclosed But Narrow Species Or Subgenus Claimed: “It is an old custom in the woods to mark trails by making blaze marks on the trees. It is no help in finding a trail or in finding one’s way through the woods where the trails have disappeared — or have not yet been made, which is more like the case here — to be confronted simply by a large number of unmarked trees. Appellants are pointing to trees. We are looking for blaze marks which single out particular trees. We see none.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967) (aff’g written description rejection of application claims). See Purdue Pharma (Fed. Cir. 10/25/00) (“One cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Purdue Pharma (Fed. Cir. 11/21/23) (aff’g PTAB PGR finding of written description unpatentability of claims reciting PPG as an adversive agent and Spec. disclosed that gelling agents are adversive agents, some surfactants are gelling agents, and PPG is example surfactant useful in the invention, but did not disclose that PPG is a gelling agent, for lack of sufficient blaze marks); (Idenix Pharm. (Fed. Cir. 10/30/19) (2-1) (rev’g denial of JMOL of written description invalidity; claims are “invalid for lack of written description, as it fails to provide sufficient blaze marks to direct a POSA to the specific subset of 2′-methyl-up nucleosides that are effective in treating HCV. …. [It] provides no method of distinguishing effective from ineffective compounds for the compounds reaching beyond the formulas disclosed in the” Spec.); Quake (Fed. Cir. 07/10/19) (aff’g written description unpatentability; two disclosures of elements of claim “are (at most) faint ‘blaze marks’ for determining fetal aneuploidy by random MPS, while the rest of the specification marks a clear trail to targeted MPS.”); Pharmacyclics (Fed. Cir. 11/15/22) (non-precedential) (aff’g sufficient blaze marks, combining disclosure in Summary of the Invention and two examples); FWP IP (Fed. Cir. 10/24/18) (non-precedential) (aff’g PTAB that senior party’s application lacked written description support for interference count reciting that 480 mg./day dosage is therapeutically effective amount for treating MS, where disclosed long list of diseases and several ranges of dosages: “The blaze marks analysis is a useful guide for evaluating laundry-list disclosures.”); Novartis (Fed. Cir. 06/21/22) (2-1) (J. Hughes replaced J. O’Malley on panel) (rev’g D. Ct. judgment that claims not invalid for lack of written description; Spec. does not support negative limitation of “administering fingolimod ‘at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen’”), vacating Novartis (Fed. Cir. 01/03/22) (2-1) (aff’g that priority app. provides written description support for dosage limitation; no need for “blaze marks” where specific claimed species is disclosed. “where the specification describes a broad genus and the claims are directed to a single species or a narrow subgenus, we have held that the specification must contain “‘blaze marks’ that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities”). Cf. Allergan (Fed. Cir. 08/13/24) (2-1) (This “is not a ‘blaze marks’ case in which the claims recite a species where the specification describes only a genus.”).
  • Written Description Disclosure Requirements: The disclosure of the claimed subject matter must be:
    • express or necessarily present (inherent), Tronzo (Fed. Cir. 08/28/98); see Yeda (Fed. Cir. 09/20/16) (aff’g claim to a protein supported by ancestor’s disclosure of partial N-terminus sequence unique to that protein: “Under the doctrine of inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.”); Allergan (Fed. Cir. 08/04/15) (claimed property inherent in formulation that was expressly disclosed); Knowles Elecs. (Fed. Cir. 03/01/18) (2-1) (aff’g PTAB decision that proposed amended claim reciting that solder pads are “configured to mechanically attach and electrically connect the package to a surface of an external printed circuit board using a solder reflow process,” not supported by Spec. that does not mention which solder process is used, where solder reflow just one of several alternative processes that could be used); but see Nalpropion (Fed. Cir. 08/15/19) (2-1) (aff’g district court finding of written description support; “while as a general matter written description may not be satisfied by so-called equivalent disclosure, … where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps,” the finding is affirmed) [see Cert. Pet. (S. Ct. 03/13/2020) (arguing against “equivalent” disclosure)].
    • complete, Lockwood, 107 F.3d at 1572 (“One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations….”),
    • unambiguous, Hyatt, 146 F.3d 1348, 1352 (Fed. Cir. 1998),
    • specific, Purdue Pharma, 230 F.3d 1320, 1322 (Fed. Cir. 2000), and
    • as broad as (full scope of) the claim, Gentry Gallery, 134 F.3d 1473, 1478-80 (Fed. Cir. 1998) (“claims may be no broader than the supporting disclosure, and therefore that a narrow disclosure will limit claim breadth.”).
  • Must Be Sufficiently Detailed: The Spec. must describe the claimed invention in sufficient detail so that PHOSITA can recognize what is claimed. “The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Univ. of Rochester (Fed. Cir. 02/13/04) (Extensive discussion of written description requirement and its history. Aff’g Summ. J. of invalidity under written description requirement. “The patent’s [method] claims all require a COX-2-selective compound, but no COX-2-selective compound is disclosed in the patent, and it is undisputed that there was no pre-existing awareness in the art of any compound having COX-2-selective activity.” The italicized part of this summary of the holding may dilute its usefulness as precedent.) “Patents are not rewarded for mere searches, but are intended to compensate their successful completion. That is why the written description requirement incentivizes ‘actual invention,’ and thus ‘[a] mere wish or plan’ for obtaining the claimed invention is not ad-equate written description.’” Nuvo Pharm. (Fed. Cir. 05/15/19) (rev’g trial court judgment of written description support).  Cf. Novartis (Fed. Cir. 01/03/22) (2-1) (distinguishing Nuvo Pharm. because here the claims do not require efficacy).
  • Disclosure Merely Rendering Claimed Invention Obvious Is Insufficient: The claimed subject matter must be disclosed in the Spec.; it is not good enough for the claimed subject matter to be obvious in view of the Spec.’s disclosure. Ariad Pharm. (Fed. Cir. 03/22/10) (en banc); Turbocare (Fed. Cir. 08/29/01) (aff’g summary judgment for failing to satisfy the written description requirement where the “original disclosure is completely lacking in any description of an embodiment in which the spring is located” where claimed, and holding that while “[s]uch an embodiment may have been obvious from” that disclosure “that is not enough to satisfy the written description requirement”); Purdue Pharma (Fed. Cir. 06/13/17) (non-precedential) (aff’g PTAB written-description unpatentability determination in interference; “To the extent that Purdue contends that a person of skill in the art would isolate and combine aspects from various embodiments in the specifications (including patents incorporated by reference involving a different drug) to obtain the claimed invention, Purdue relies upon the wrong test.”); Rivera (Fed. Cir. 05/23/17) (Spec. “does not teach a container with an integrated filter, and so, does not provide written description support for such a container, even if that type of container might be rendered obvious by the specification.”); Los Angeles Biomedical (Fed. Cir. 02/28/17) (aff’g PTAB IPR decision claim not supported by provisional: “proof of priority requires written description disclosure in the parent application, not simply information and inferences drawn from uncited references”); In re Huston (Fed. Cir. 10/17/02) (aff’g claims not entitled to parent date; disclosing enough to make claim obvious insufficient).
  • Claimed Combination Of Features Must Be Disclosed: “A patent owner cannot show written description support by picking and choosing claim elements from different embodiments that are never linked together in the specification.” Flash-Control (Fed. Cir. 07/14/21) (non-precedential) (aff’g Summ. J. written description invalidity); Taylor (18-1048) (Fed. Cir. 04/03/2020) (non-precedential) (aff’g Summ. J. rejection in Sec. 145 action of claims combining features identified in Spec. but not described in combination with each other); Taylor (18-1070) (Fed. Cir. 04/03/20) (non-precedential) (same); Purdue Pharma (Fed. Cir. 06/13/17) (non-precedential) (aff’g PTAB written-description unpatentability determination in interference where claims combining features identified in Spec. but not described in combination with each other). See Hyatt (Fed. Cir. 06/28/07) (aff’g ex parte rejection of claims on ground that “while each element may be individually described in the specification, the deficiency was the lack of adequate description of their combination”).
  • When Claim Recites A Closed Range, Skilled Artisan Must Be Able To “Reasonably Discern” That Claimed Range In The Application: Indivior UK (Fed. Cir. 11/24/21) (2-1) (aff’g PTAB that claimed ranges not supported by written description of various values and different ranges in asserted priority ancestor app. (and therefore anticipated by publication of that app.): “A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.”); Gen. Hosp. (Fed. Cir. 05/04/18) (aff’g claimed range lacked written description support. “[W]here a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to ‘immediately discern the limitation at issue in the claims.’” “The disclosure of a range of concentrations from less than 1 × 1011 particles per ml to some unidentified maximum, does not provide written description support for the claimed concentration of ‘about 6.6 × 1011 particles per ml,’ nor does the disclosure of particular discrete values within that range, none of which are the claimed value.”); Purdue Pharma (Fed. Cir. 10/25/00) (claimed concentration ratio above 2 not supported where Spec. had examples above and below 2, did not emphasize that ratio as aspect of invention, and lacked blaze marks to that range of that ratio); Columbia Insur. (Fed. Cir. 03/31/23) (2-1) (non-precedential) (aff’g PTAB PGR finding skilled artisan could not “reasonably discern” from disclosure of lower-bound sized member the claimed range of member sizes defined by “a lower bound (large enough to fit two layers of ⅝- inch-thick sheathing) and an upper bound (too small to fit three layers of ⅝-inch-thick sheathing)”); But see RAI Strategic (Fed. Cir. 02/09/24) (rev’g PTAB PGR finding of written description unpatentability; claim recited heating element length about 75% to about 85% of length of heated substance and Spec. described ranges of 75%–125%, 80%–120%, 85%–115% and 90%–110%, because “no evidence suggesting that the” broader disclosed ranges “disclose a different invention than the claimed range of “about 75% to about 85%,” and noting that mechanical arts are more predictable, and distinguishing Indivior); In re Wertheim (CCPA 04/09/81) (aff’g Examiner rejection that ancestor app. did not provide written description support for claimed solids content of “at least 35%,” but rev’g same ruling for claims reciting “between 35% and 60%,” where Spec. disclosed  “a concentration of 25 to 60% solid matter is reached” and specific embodiments having solids contents of 36% and 50%: “as a factual matter, persons skilled in the art would consider processes employing a 35-60% solids content range to be part of appellants’ invention and would be led by the Swiss disclosure so to conclude”).
  • When Spec. Discloses A Number Of Ranges, That May Not Support A Claim Reciting End Point Of One Of Those Ranges: Biogen (Fed. Cir. 11/30/21) (2-1) (aff’g judgment of no written description support: that Spec. makes only one reference to later-claimed dosage (480 mg/day) “constitutes a significant fact that cuts against Biogen’s case, particularly because it appears at the end of one range among a series of ranges, including DMF concentrations of 100–1,000, 200–800, 240–720, and 480–720 mg/day. That is in stark contrast to DMF720, which is referenced independently as one dose ….” No clear error in finding “a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF dosage range and not listed as an independent therapeutically efficacious dose.”), rehearing en banc denied (Fed. Cir. 03/16/22) (6–3) (Lourie, J., dissenting) (errors to (1) compare amount of disclosure of the claimed species versus the unclaimed subject matter, (2) put burden on patentee to prove efficacy, (3) imported considerations of operability, best mode and inventorship, (4) improper use of extrinsic evidence beyond understanding what disclosure would have disclosed to skilled artisan). But see Novartis (Fed. Cir. 01/03/22) (2-1) (where Spec. discloses specific claimed dosage, disclosure of wide ranges elsewhere in Spec. does “not diminish the literal description of the 0.5 mg/day dose in the Prophetic Trial”), vacated Novartis (Fed. Cir. 06/21/22) (2-1) (J. Hughes replaced J. O’Malley on rehearing) (rev’g D. Ct. finding that negative limitation was disclosed).
  • Improper To Use Hindsight Guided By Issued Claim To Pluck Claim Elements From Disparate Parts Of Disclosure: Flawed approach to “‘work[] backward from a knowledge of [the claims], that is by hindsight,” [and] seek[] to derive written description support from an amalgam of disclosures plucked selectively from” the application. Novozymes (Fed. Cir. 07/22/13) (aff’g JMOL that claim invalid for lack of written description support in provisional application despite that application disclosed each element of the claim, when “viewing the matter from the proper vantage point ‘of one with no foreknowledge of the specific compound’”); see Indivior UK (Fed. Cir. 11/24/21) (2-1) (aff’g PTAB that claimed ranges (“about 40 wt % to about 60 wt % of a water-soluble polymeric matrix”; “about 48.2 wt % to about 58.6 wt %”) not supported by ancestor app.’s disclosure of “at least 25%,” “at least 50%,” example amounting to 48.2%, example amounting to 58.6%, other examples amounting to values between 40% and 60%, in part because “one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the [ancestor app.] to create an otherwise unstated range. That is not a written description of the claimed range.”); In re Ruschig (CCPA 06/02/67) (“It is … easy to imagine that the compound of claim 13 might have been named in the specification. Working backward from a knowledge of chlorpropamide, that is by hindsight, it is all very clear what route one would travel through the forest of the specification to arrive at it. But looking at the problem, as we must, from the standpoint of one with no foreknowledge of the specific compound” claimed, there was no support.)
  • Absence Of Disclaimer Of Broader Scope Is Not Same As Disclosing That Broader Scope: D Three (Fed. Cir. 05/21/18) (aff’g Summ. J. that two sets of genus claims unsupported; rejecting patent owner argument that priority app. lacked any “disclaimer that would require the washer to be atop the flashing as opposed to below,” because “adequate written description does not ask what is permissible, rather, it asks what is disclosed.”) Cf. In re Global IP Holdings (Fed. Cir. 07/05/19) (vacating PTAB rejection of reissue application claim broadening element from “thermoplastics” to “plastics,” explaining that “criticality” or importance of feature may affect determination of whether narrow disclosure supported broader claim).
  • Future Technology Encompassed By Claim Must Be Described: Future technology encompassed by a claim need not be enabled, but it must be described in the application to satisfy the written description requirement: “The jury may have found that the 1984 application does not provide any support for the new matter, chimeric antibodies, claimed in the ’561 patent. Because chimeric antibody technology did not even exist at the time of the 1984 filing, the record conclusively supports that the Chiron scientists did not possess and disclose this technology in the February 1984 filing.” Chiron (Fed. Cir. 03/30/04) (Series of CIPs filed. Last application defined claim term “monoclonal antibody” to include chimeric and humanized antibodies. Prior applications did not enable (and/or did not disclose) use of chimeric antibodies. Thus, claims not entitled to earlier applications’ filing dates, and thus anticipated by intervening prior art. Affirmed denial of JMOL seeking to overturn jury verdict of invalidity.)
  • A Negative Limitation Must Be Disclosed Expressly, Such As A Reason To Exclude That Element, Or Inherently: Novartis (Fed. Cir. 06/21/22) (2-1) (J. Hughes replaced J. O’Malley on rehearing) (rev’g D. Ct. finding that negative limitation was disclosed; “While a written description’s silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation.” “The question is not whether the patentee intended there to be a loading dose; the question is whether the patentee precluded the use of a loading dose.” Probabilities are insufficient.), vacating Novartis (Fed. Cir. 01/03/22) (2-1) (discussing “negative limitation” written description case law; aff’g priority app. supported negative limitation (without immediately preceding loading dose); in Santarus “we did not hold that a specification must describe a reason to exclude a negative limitation”), mandate stayed (U.S. 09/29/2022) on emergency application (09/28/2022). Claim limitation excluding something is supported by Spec. describing a reason to exclude that element. Santarus (Fed. Cir. 09/04/12) (rev’g written description invalidity); but see Inphi (Fed. Cir. 11/13/15) (aff’g PTAB that negative claim limitation (excluding three types of chips) supported by written description: per MPEP, “If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims.”; if Spec. does not foreclose the negative limitation).
  • Claim Language Need Not Be Used in Spec. In Haec Verba: Blue Calypso (Fed. Cir. 03/01/16) (rev’g PTAB decision of written description invalidity).
  • When Assessing What Description Discloses To PHOSITA, Common Sense Matters: “As the Supreme Court [in KSR] has made clear, when assessing what the written description reveals to a skilled artisan, common sense also matters.” Novartis (Fed. Cir. 01/03/22) (2-1) (aff’g that priority app. supports negative limitation).
  • Cannot Fix Claims To Cure Written Description Defect: Court will not rewrite unambiguously illogical claims to cure disconnect between claims and written description. Energizer (Fed. Cir. 04/21/08) (aff’g ITC written description invalidity determination) (non-precedential); Chef Am. (Fed. Cir. 02/20/04) (“heating the resulting batter-coated dough to a temperature in the range of about 400° F. to 850° F” “means what it says (the dough is to be heated ‘to’ the designated temperature range),” rejecting argument that the claim only specifies the temperature at which the dough is to be heated, even though as claimed, “it would be burned to a crisp”); cf. Alcon Research (Fed. Cir. 08/08/12) (“Courts do not rewrite the claims to narrow them for the patentee to cover only the valid portion.” (Prior art invalidity context)); Power Integrations (Fed. Cir. 09/20/18) (distinguishing Chef Am. “where the claims were unambiguously written in a manner that rendered them inoperable”). But “Chef America does not require us to depart from common sense in claim construction.” Alterwan (Fed. Cir. 03/13/23) (rev’g claim construction that would require the impossible: claim language does “not unambiguously require bandwidth to be available even when the Internet is inoperable”).
  • Unexpected Results Supporting Non-Obviousness May Also Help Show Lack Of Written Description Support: “In light of the fact that the specification provides nothing more than the mere claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought it would work, the specification is fatally flawed. It does not demonstrate that the inventor possessed more than a mere wish or hope that uncoated PPI would work, and thus it does not demonstrate that he actually invented what he claimed: an amount of uncoated PPI that is effective to raise the gastric pH to at least 3.5.” Nuvo Pharma. (Fed. Cir. 05/15/19) (rev’g trial court judgment of written description support; although experimental data generally not required, where claims require a level of therapeutic effectiveness and patent owner showed skilled artisan would not have expected claimed results from claimed subject matter, and Spec. lacked efficacy data or anything else teaching otherwise, the claims lack written description support).
  • Prior Art May Help Demonstrate Written Description Support: descriptions in patent coupled with well-known knowledge in the art sufficiently disclosed the claimed subject matter. Streck (Fed. Cir. 01/10/12) (aff’g Summ. J. in favor of patent owner); Hologic (Fed. Cir. 03/14/18) (disclosure of one type of light guide sufficient to support claim element “light guide” in part because “various types of light guides were well-known in the art.” Proper to “consider[] what the specification reasonably conveys to the skilled artisan who has knowledge of the prior art.”); Immunex (Fed. Cir. 07/01/20) (aff’g priority application had sufficient written description in part because disclosure in Spec. would have encouraged skilled artisan to look to prior art reference disclosing allegedly missing subject matter).
  • Applicant’s Failures May Help Demonstrate Lack Of Written Description Support: Taylor (18-1070) (Fed. Cir. 04/03/20) (non-precedential) (aff’g ex parte rejection of claims; relying in part on applicant’s admissions that he had to wait for other technology developments in order to proceed implementing his invention, showing “that the specification did not demonstrate possession of the claimed invention but was instead ‘a ‘mere wish or plan’ for obtaining the claimed invention.’”).
  • Must Determine What Disclosure Meant At The Time Of The Invention: May consider post-filing publications only to the extent they evidence understanding at or before the filing date under consideration. Stanford Univ. (Fed. Cir. 06/27/17) (vacating decision in interference that an alleged priority application lacked written description support for claim) [subsequent appeal: Quake (Fed. Cir. 07/10/19) (aff’g PTAB decision claims in interference unpatentable for lack of written description support in priority application)].
  •  Lower Level Of Detail Needed To Meet Written Description Requirement In Predictable Arts: “A lower level of detail is required to satisfy the written description requirement” in a predictable art. Hologic (Fed. Cir. 03/14/18) (aff’g PTAB that ancestor PCT had sufficient written description for claims); Centrak (Fed. Cir. 02/14/19) (rev’g Summ. J. of written description invalidity; Spec. focused on IR implementation but added two sentences that invention could be implemented using ultrasonic instead; genuine dispute of material fact whether differences between using ultrasonic and IR “are incidental to carrying out the claimed invention”); In re Global IP Holdings (Fed. Cir. 07/05/19) (vacating PTAB rejection of reissue application claim broadening element from “thermoplastics” to “plastics,” instructing that predictability was relevant consideration).

a) which disclosure governs

  • Decisions Divided On Whether Alleged Priority Application, Or Issued Application, Is Subject Of Written Description Invalidity Analysis: The Federal Circuit has treated as the subject of the Sec. 112 invalidity analysis the ancestor application whose filing date the patent owner seeks as the patent’s effective filing date. Synthes (Fed. Cir. 10/29/13) (aff’g jury verdict of written description invalidity, based on disclosure of original German-lang. PCT app.); Biogen (Fed. Cir. 11/30/21) (2-1) (aff’g judgment of no written description based on asserted priority application and asserted priority date); Novozymes (Fed. Cir. 07/22/13) (“claims added during prosecution must find support sufficient to satisfy § 112 in the written description of the original priority application.” Claims invalid due to insufficient disclosure in provisional application followed by series of continuations); Centocor (Fed. Cir. 02/23/11) (overturning $1.67 Billion damages award; claims “invalid for lack of written description” because inadequate disclosure in ancestor application (to which the patent owner claimed “priority,” and jury agreed in special verdict) that was followed by two CIPs, a continuation, and a divisional that issued as the patent in suit. But needed that date also to predate alleged infringer’s own patent application.). But a literal reading of Secs. 112 and 120, suggests that the written-description-invalidity analysis applies only to the actual application that issued as the patent, not ancestor applications which instead are analyzed for entitlement to claim backdating under Sec. 120. The Federal Circuit has made this distinction. “Both parties wrongly assume that, if the 2006 priority application lacks sufficient written description of the ’405 patent’s claims, those claims are invalid. If the 2006 priority application lacks sufficient written description for the ’405 patent’s claims, the ’405 patent’s claims are not automatically rendered invalid; they are merely deprived of the 2006 priority date.” Novartis (Fed. Cir. 01/03/22) (2-1) (aff’g that priority app. provides written description supported for dosage limitation and for negative claim limitation, faulting parties for focusing on issued Spec. rather than asserted priority app.), vacated, Novartis (Fed. Cir. 06/21/22) (2-1) (J. Hughes replaced J. O’Malley on rehearing) (rev’g D. Ct. finding that negative limitation was disclosed); Reiffin v. Microsoft, 214 F.3d 1342 (Fed. Cir. 2000); see Trading Techs. II (Fed. Cir. 08/30/13) (granting Summ. J. of written description support based on the CIP app. without discussing effective-filing-date sought); Hayward (Fed. Cir. 02/07/18) (non-precedential) (aff’g PTAB that incorporated priority application supplied written description support, arguably implying that but for incorporation the priority application would not have mattered). So, for now, best to assert both invalidity under Sec. 112 and lack of entitlement to filing date under Sec. 120, when challenging ancestor application support.
  • Disclosure Measured As Of Date Of Effective Filing Date Sought: Regardless of which disclosure is analyzed, it is analyzed as of the date of the effective filing date sought. E.g., Ariad Pharm. (Fed. Cir. 03/22/10) (en banc) (“a written description analysis occurs ‘as of the filing date sought’”); Juno (Fed. Cir. 08/26/21) (rev’g denial of JMOL of no full-scope written description support, and damages award of $1.2 BB, looking to asserted priority date and ruling developments after that date irrelevant); Vas-Cath (Fed. Cir. 06/07/91) (“the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention”); Biogen (Fed. Cir. 11/30/21) (2-1) (aff’g judgment of no written description based on asserted priority application and asserted priority date).
  • Post-Filing Drawings Cannot Supplement The Disclosure: “Drawings submitted after the filing date of the application may not be used (i) to overcome any insufficiency of the specification due to lack of an enabling disclosure or otherwise inadequate disclosure therein, or (ii) to supplement the original disclosure thereof for the purpose of interpretation of the scope of any claim.” 35 U.S.C. § 113.

b) support “full scope” of claim

  • Disclosure Must Support Full Scope Of Claim: “The written description must lead a person of ordinary skill in the art to understand that the inventors possessed the entire scope of the claimed invention.” Juno (Fed. Cir. 08/26/21) (rev’g denial of JMOL of no full-scope written description support, and damages award of $1.2 BB: the disclosure of two working embodiments “does not provide information sufficient to establish that a skilled artisan would understand how to identify the species of scFvs capable of binding to the limitless number of targets as the claims require”); Rivera (Fed. Cir. 05/23/17) (aff’g ITC invalidity decision: Spec. “consistently describes an invention in which the ‘pod’ [containing coffee] and the receptacle or container are distinct components. Thus, … written description support for broad claims covering a receptacle with integrated filter such as … accused products … is lacking.”); Nintendo (Fed. Cir. 12/27/17) (non-precedential) (aff’g PTAB that ancestor app. supported claim; because claims’ “communications device” included telephones, personal computers, and other devices, as shown by dependent claims, “the Board could not—and did not—conclude that indicating means 41 and its RF transmitter [in the ancestor application], standing alone, demonstrate possession of the challenged claims,” instead ancestor application disclosures showed applicant “possessed the full scope of communication devices in exemplary claim 1, including telephones and personal computers.”); Gentry Gallery, 134 F.3d 1473, 1478-80 (Fed. Cir. 1998); see Atlantic Research (Fed. Cir. 10/06/11) (aff’g Summ. J. of invalidity for lack of written description where claims added on reissue required only one attachment point, but Spec. disclosed that having two attachment points was a “critical feature[]” and “describes an invention that is supported by both the barrel nut and attachment to the upper receiver via a receiver sleeve.” Claims invalid because they “exceed in scope the subject matter that [applicant] chose to disclose to the public in the written description.”); Festo (U.S. 05/28/2002) (“What is claimed by the patent application must be the same as what is disclosed in the specification; otherwise the patent should not issue.” (quoted with approval in AbbVie (Fed. Cir. 07/01/14) (aff’g denial of JMOL; jury verdict invalidity under written description requirement)); MacKay (U.S. 01/30/1939) (where application as filed described invention as taking the angle of an existing formula as the angle between each wire of the V antenna and its bisector, which formula depended on using antenna wires of a length which is a multiple of half wave lengths, but “broad claims, embrac[ing] all V antennae arranged at an angle double the angle of the empirical formula, even though the length of the wires is not an exact multiple of half wave lengths,” “we think that the attempt to extend the claims, based on the application of the empirical formula, to wire lengths not multiples of half wave lengths, must fail, because such structures are not within the invention described in the application,” and objecting to “full effect [being] given to a claim which goes beyond the invention described.” “Claims 15 and 16, so far as they claim antennae of wire lengths intermediate of multiples of half wave lengths, are invalid.”); O’Reilly (U.S. 1853) (“cannot claim what he has not described and indeed had not invented, and therefore could not describe when he obtained his patent”; claims by inventor of telegraph to “use of … electro-magnetism, however developed for making or printing intelligible characters … at any distances” invalid. “The evil is the same if he claims more than he has invented, although no other person has invented it before him. He prevents others from attempting to improve upon the manner and process which he has described in his specification — and may deter the public from using it, even if discovered. He can lawfully claim only what he has invented and described, and if he claims more his patent is void.” (partially quoted with approval in AbbVie (Fed. Cir. 07/01/14)); Sanofi-Aventis (20-2066) (Fed. Cir. 12/29/21) (non-precedential) (aff’g PTAB that foreign priority application disclosing threaded piston rod and embodiment with external threads did not support original claim reciting internal or external threads or proposed substitute claims reciting genus of threaded piston rod); Verify Smart (Fed. Cir. 08/05/20) (non-precedential) (aff’g PTAB ruling amended claim reciting tracking any communications device not supported by written description of tracking cell phone, because introduced new matter); cf. Ruckus Wireless (Fed. Cir. 05/31/16) (2-1) (construing “communications path” to be limited to wired path, in part to avoid written-description invalidity, quoting Gentry Gallery: “a claim ‘may be no broader than the supporting disclosure’.”); Rozbicki (Fed. Cir. 11/14/14) (non-precedential) (interference party failed to preserve written-description “full scope” argument when argued only that Spec. failed to disclose a certain embodiment); Honeywell (Fed. Cir. 02/18/10) (rev’g written description invalidity; original disclosure not limited to CRT displays); Merck Sharp (Fed. Cir. 06/09/20) (non-provisional) (aff’g PTAB that provisional disclosures of certain strand lengths supported claims not specifying strand length, without mentioning “full scope”).
    • But see Medtronic (21-2359) (Fed. Cir. 06/05/23) (aff’g PTAB that substitute claims had written description support in priority application where Spec. described side opening only as part of substantially rigid segment but substitute claims encompass side opening separate from substantially rigid segment. “If the precise location of the side opening was not an element of the invention, claims that do not recite the location as a limitation are not ‘unsupported by the specification even though [they] would be literally infringed by undisclosed embodiments.’” “Written description requires only that a skilled artisan would reasonably conclude, based on the patent’s disclosures and the knowledge of a person skilled in the art, that the applicant possessed catheters in which the side opening could be located outside the rigid segment.”).
    • TIPS:

c) omission of non-optional element

  • Claim Omitting Non-Optional Element Or Encompassing Excluded Element May Be Too Broad To Have Written Description Support: “A description can be broadened by removing limitations.” Anascape (Fed. Cir. 04/13/10) (CIP added “new matter” by removing limitations required in parent application.) Sometimes (e.g., Lockwood (Fed. Cir. 03/04/97)) a claim fails this written description requirement by adding an element not disclosed in the Spec., in which case the claim does not “read on” the Spec. Other times, however, a claim does “read on” the Spec. but still is not supported by the Spec., because the claim omits an element required by the Spec. e.g., Arthrex (Fed. Cir. 05/27/22) (aff’g PTAB finding that claims not entitled to priority date of ancestor’s filing date where generic claim element encompassed both flexible and rigid eyelets but ancestor application criticized flexible eyelet design described in incorporated parent application and instead touted rigid eyelet as solving problems associated with flexible eyelets); Tronzo (Fed. Cir. 08/28/98); Gentry Gallery (Fed. Cir. 01/27/98); Lizardtech (Fed. Cir. 10/04/05) (aff’g Summ. J. written description invalidity: “The trouble with allowing claim 21 to cover all ways of performing DWT-based compression processes that lead to a seamless DWT is that there is no support for such a broad claim in the specification. The specification provides only a single way of creating a seamless DWT, which is by maintaining updated sums of DWT coefficients. There is no evidence that the specification contemplates a more generic way of creating a seamless array of DWT coefficients.”); Bamberg (Fed. Cir. 03/07/16) (aff’g PTAB decision of no written description support for count; citing Tronzo with approval; BRI based on other party’s disclosure includes white layers that melt below or above 220°C, but disclosure “does not possess a white layer that melts below 220°C because it specifically distinguished white layers that melt below 220°C as producing an ‘undesired” result.”); ICU Med. (Fed. Cir. 03/13/09) (aff’g Summ. J. of written-description invalidity; disclosure of medical valve embodiments with spike did not support claims broad enough to cover both spike and spikeless designs; to be valid, claim must include a spike because “a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”); Anascape (Fed. Cir. 04/13/10) (rev’g denial of JMOL that upheld jury verdict backdating claim, where issued claims are broader than six degrees-of-freedom single input member invention in parent app. per parent app.’s claims, summary of the object, drawings, etc.), Research Corp. Tech. (Fed. Cir. 12/08/10) (parent application limited “invention” to a blue noise mask, so claims in later-filed continuation applications (with same written description) not requiring a blue noise mask were not supported by (and not entitled to filing date of) that parent application); Atlantic Research (Fed. Cir. 10/06/11) (aff’g Summ. J. of invalidity for lack of written description where claims added on reissue required only one attachment point, but Spec. disclosed that having two attachment points was a “critical feature[]” and “describes an invention that is supported by both the barrel nut and attachment to the upper receiver via a receiver sleeve.”); Shimano (Fed. Cir. 04/29/13) (non-precedential) (aff’g Board written description rejection: “Because the disclosure in the specification of the structure of the extended pawl was very detailed, and because the reason for the extended portion being narrower than the other portions of the pawl was explicitly identified, the effect of the amendment to the claim language was to extend the reach of that claim to structures not described in the specification, without any disclosure as to how those modified structures would perform the function designated for them by the patent.”); Mukherjee (Fed. Cir. 02/15/07) (non-precedential) (aff’g Board rejecting claims for omitting an essential, non-optional element from Spec.); Transperfect (Fed. Cir. 07/12/17) (non-precedential) (aff’g PTAB CBM finding of no written description support for claims; PTAB “correctly found that a person of ordinary skill in the art would not have understood that the inventors … possessed and described a plug-in that could perform a translation without using replacement hyperlinks.”) Cf. Carnegie Mellon (Fed. Cir. 09/08/08) (holding that disclosure of species did not describe claimed genus: “the patents teach that the specific gene sequence for the expression of DNA polymerase I or nick-translation activity is a critical aspect of the invention.”); Consolidated Elec. Light (U.S. 11/11/1895) (claim covering use of any textile material in incandescent light bulb invalid as not supported by disclosure using carbonized paper). But see Allergan (Fed. Cir. 08/13/24) (2-1) (rev’g finding of no written description support for a claim that omits reference to a glidant, which district court found appeared in each embodiment but majority found two embodiments, and an originally filed claim, which “contemplate a formulation in which a glidant is optional,” and Spec. did not associate any particular function or significance to the glidant, distinguishing ICU Medical); Revolution Eyewear (Fed. Cir. 04/29/09) (aff’g rejection of written description defense; a claim need not address each problem with the prior art identified in the Spec.: even where “the problems addressed by the invention are related, … [i]nventors can frame their claims to address one problem or several, and the written description requirement will be satisfied as to each claim as long as the description conveys that the inventor was in possession of the invention recited in that claim.”); Scriptpro II (Fed. Cir. 08/15/16) (rev’g Summ. J. of invalidity; disclosed invention not limited to requiring particular feature (sorting containers by patient-identifying information), despite focusing on it, as shown in part by the originally filed claims; distinguishing Gentry Gallery and ICU Medical); Scriptpro I (Fed. Cir. 08/06/14) (non-precedential) (rev’g Summ. J. of written description invalidity, finding genuine dispute whether omitted element was essential, “A specification can adequately communicate to a skilled artisan that the patentee invented not just the combination of all identified features but combinations of only some of those features (subcombinations)—which may achieve stated purposes even without omitted features.”)
    • Note: No Separate “Essential Elements” Test: E.g., Carnegie Mellon (Fed. Cir. 09/08/08) (Gentry Gallery did not create an “essential elements” test).
  • But Claims Need Not Include Invention’s Solution To Each Problem Described In Spec.: Revolution Eyewear (Fed. Cir. 04/29/09) (aff’g rejection of written description defense; a claim need not address each problem with the prior art identified in the Spec.: even where “the problems addressed by the invention are related … [i]nventors can frame their claims to address one problem or several, and the written description requirement will be satisfied as to each claim as long as the description conveys that the inventor was in possession of the invention recited in that claim.”); Crown Packaging (Fed. Cir. 04/01/11) (2-1, Dyk, J. dissenting) (rev’g Summ. J. of written description invalidity, and distinguishing Tronzo and LizardTech and ICU Med.: where Spec. discloses multiple solutions to multiple problems and does not require that they be used in combination, as shown in part by original claims as filed, “‘[i]nventors can frame their claims to address one problem or several.’”); accord Scriptpro II (Fed. Cir. 08/15/16) (rev’g Summ. J. of invalidity; feature not required by all purposes identified in the specification; distinguishing Gentry Gallery and ICU Medical); Cordis (Fed. Cir. 06/29/06) (non-precedential) (rejecting reliance on Tronzo where Spec. disclosed two distinct problems and solutions and claims were directed to only one: “nothing in the patent suggests that the benefits of undulating sections are tied in any way to ring stents” and evidence showed that “the undulating longitudinal structures … could ‘clearly’ be used in conjunction with non-ring stents”). See AstraZeneca (Fed. Cir. 10/30/13) (non-precedential) (claim construction context: “statements with respect to ‘the invention’ are ambiguous at best, given the three distinct types of inventions (processes, products, and methods of use) described in the specification”); Zoltec III (Fed. Cir. 02/19/16) (rev’g written description invalidity; timely reissue claim may omit well-described and well-known preliminary step even though it broadens who may infringe).
  • Claims Sometimes May Instead Be Construed Narrowly To Avoid Written Description Disconnect: Intellectual Ventures (Motorola) (Fed. Cir. 09/13/17) (aff’g denial of written description invalidity JMOL; Spec. distinctions over prior art narrow the claim scope so no written description invalidity: Spec. excerpts “demonstrate that storing files ‘indefinitely’ on an intervening computer is not part of the claimed invention. …. The proper result is not that claim 41 fails for lack of written description but that it should be construed ‘in view of the specification’ to be limited.”); R. Bard (Fed. Cir. 09/30/98) (“it is incorrect to construe the claims contrary to the specification, and then to hold the claims invalid because they are contrary to the specification. [T]he claims are construed in accordance with the rest of the specification of which they are a part, and not contrary to it.”)
    • TIPS:

d) original claims

  • Original Claims May Lack Written Description Support: Even a claim filed with the original application may lack written-description support: “[The claims’] principal function, therefore, is to provide notice of the boundaries of the right to exclude and to define limits; it is not to describe the invention, although their original language contributes to the description and in certain cases satisfies it. Claims define and circumscribe, the written description discloses and teaches.” Ariad Pharm. (Fed. Cir. 03/22/10) (en banc). “If a purported description of an invention does not meet the requirements of the statute, the fact that it appears as an original claim or in the specification does not save it. A claim does not become more descriptive by its repetition, or its longevity.” Enzo Biochem (Fed. Cir. 07/15/02). But see Mentor Graphics (Fed. Cir. 03/16/17) (rev’g written description invalidity judgment; allegedly unsupported claim language was precisely in original claims as filed, which original claims here “raise none of the genus/species concerns that have caused us to question whether originally filed claims satisfy written description.”)

e) functional claims

  • “Functional Claims” Require Disclosure Of How Achieved: “The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts.… Such claims merely recite a description of the problem to be solved while claiming all solutions to it and … cover any compound later actually invented and determined to fall within the claim’s functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad Pharm. (Fed. Cir. 03/22/10) (en banc); Impact Engine (Fed. Cir. 07/03/24) (non-precedential) (aff’g no written description support for “a compiling engine for integrating …, and for grouping … so as to …,” where “compiling engine” construed to mean “a program that does ‘back-end processing of source code into machine or object code,’” for failure to describe “a program that performs the defining function of a ‘compiling engine’ (source-code-into-machine-code processing) as also performing the other functions required by claim”); Cf. Vasudevan Software (Fed. Cir. 04/03/15) (rev’g Summ. J. of no written description where genuinely disputed facts on whether Spec. disclosed how to achieve claimed result); GlaxoSmithKline (Fed. Cir. 02/24/14) (aff’g rejection of written description defense; distinguishing a “functional” element from an element requiring that it be produced by a certain process).
  • Functional Genus Claim Requires Disclosure Of Sufficient Species To Show Possession Of Generic Invention: A generic (genus) claim using functional language to define its boundaries, e.g., claiming a desired result, requires the Spec. to “demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Ariad Pharm. (Fed. Cir. 03/22/10) (en banc); Juno (Fed. Cir. 08/26/21) (rev’g denial of JMOL of no full-scope written description support, and damages award of $1.2 BB, where Spec. provides “no means of distinguishing which scFvs will bind to which targets.” “The disclosure of one scFv that binds to CD19 and one scFv that binds to a PSMA antigen on prostate cancer cells in the manner provided in this patent does not provide information sufficient to establish that a skilled artisan would understand how to identify the species of scFvs capable of binding to the limitless number of targets as the claims require.”); AbbVie (Fed. Cir. 07/01/14) (“must adequately describe representative antibodies to reflect the structural diversity of the claimed genus”); Pfizer (Fed. Cir. 02/06/14) (non-precedential) (“For claims to a chemical compound, an application satisfies the written description requirement when it details ‘relevant identifying characteristics’ such that the compound can be distinguished from other compounds.”)

f) genus claims

  • Species (or Sub-Genus) May Or May Not Support Genus: “A patent claiming a genus must disclose ‘a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.’ Evidence showing that a claimed genus does not disclose a representative number of species may include evidence of species that fall within the claimed genus but are not disclosed by the patent, and evidence of such species is likely to postdate the priority date.” Amgen (Sanofi) I (Fed. Cir. 10/05/17) (granting new trial to patent challenger on written description and enablement defenses; post-priority-date evidence improper to show state of the art post priority date but proper to show that a patent fails to disclose a representative number of species); BASF (Fed. Cir. 03/15/22) (aff’g jury verdict that species of canola is supported by Spec. (where identified as preferred embodiment and Spec. includes working examples of another species that skilled artisans recognized as “was highly predictive of positive results in canola,” despite lack of actual reduction to practice for canoloa), but rev’g jury verdict of written description support as to genus claims encompassing any plants because patent owner had no relevant response to the challenger’s “thin” evidence that the working examples were insufficient to support the genus); Ajinomoto (Fed. Cir. 08/06/19) (aff’g ITC finding that genus was adequately supported by representative species where invention lied elsewhere, the Spec. gave four examples, and the claimed genus was already well explored in the relevant art by the time of the patent’s invention. “Adequate written description does not require a perfect correspondence between the members of the genus and the asserted common structural feature; for a functionally defined genus … we have spoken more modestly of a ‘correlation between structure and function.’”); D Three (Fed. Cir. 05/21/18) (aff’g Summ. J. that two sets of genus claims unsupported: (1) where priority app.’s only disclosure of a washerless assembly “consistently has one type of attachment bracket,” and did not disclose that bracket as an “optional feature,” and “in no way contemplates the use of other types of attachment brackets in a washerless assembly,” that disclosure did not support claims more broadly encompassing washerless assembly with a “genus of attachment brackets” not limited to the disclosed bracket; (2) where priority app.’s only washer embodiments placed washer only above the flashing, claims reciting washer but not requiring that location were not supported: “The lack of any disclosure of an assembly with a washer below the flashing, or statement on the flexibility of the position of the washer, is fatal to D Three’s argument.”); Allergan (Fed. Cir. 12/22/17) (non-precedential) (aff’g judgment of no written description invalidity where no more than six possible species in the genus: “Even a single representative embodiment can support written description of a claimed genus.”) Where performance of non-disclosed species is unpredictable, then disclosed species may not support genus claim. Bilstad (Fed. Cir. 10/07/04) (surveys cases); Billups-Rothenberg (Fed. Cir. 04/29/11) (aff’g Summ. J. of written description invalidity of claim to method for identifying genus of unknown genetic mutations); Carnegie Mellon (Fed. Cir. 09/08/08) (“To satisfy the written description requirement in the case of a chemical or biotechnological genus, more than a statement of the genus is normally required. One must show that one has possession, as described in the application, of sufficient species to show that he or she invented and disclosed the totality of the genus.”); Boston Sci. (Fed. Cir. 06/07/11) (aff’g Summ. J. of inadequate written description of later-claimed genus of macrocyclic lactone analogs of rapamycin, where no analogs were disclosed in the Spec., only a small number of analogs were known in the art but the claims cover tens of thousands of possible analogs, and art was unpredictable and nascent; thus no “blaze marks” that claimed sub-genus might be of special interest); In re Alonso (Fed. Cir. 10/30/08) (Extensive discussion, rejecting biotechnology claim.); Trading Tech. (Fed. Cir. 02/25/10) (“one of ordinary skill in the art would have known about other forms of ‘single action’ such as a double-click or pressing a key. Considering the undisputed knowledge of those skilled in the art, disclosure of a species in this case provides sufficient written description support for a later filed claim directed to a very similar and understandable genus.”); cf. In re Global IP Holdings (Fed. Cir. 07/05/19) (“[W]e hold that, in some cases, the criticality or importance of the expressly disclosed species may be relevant to whether an inventor had possession of a claimed genus.”); Purecircle (Fed. Cir. 01/02/24) (non-precedential) (“aff’g Summ. J. written description invalidity of functional genus claim (per parties’ stipulated functional construction of a claim term); “while a single example can provide written description support for a genus, that is not the case unless the specification provides the required ‘blaze marks.’” “In short, the one enzyme disclosed in the patents here has not been shown to be typical of the entire genus of UGTs claimed. Under such circumstances, there is no adequate written description.”) See generally Ariad Pharm. (Fed. Cir. 03/22/10) (en banc); Hynix Semiconductor (Fed. Cir. 05/13/11) (single species may suffice to describe genus constituting two species). But see Medtronic (21-2359) (Fed. Cir. 06/05/23) (aff’g PTAB that substitute claims had written description support in priority application where Spec. described side opening only as part of substantially rigid segment but substitute claims encompass side opening separate from substantially rigid segment. “If the precise location of the side opening was not an element of the invention, claims that do not recite the location as a limitation are not ‘unsupported by the specification even though [they] would be literally infringed by undisclosed embodiments.’” “Written description requires only that a skilled artisan would reasonably conclude, based on the patent’s disclosures and the knowledge of a person skilled in the art, that the applicant possessed catheters in which the side opening could be located outside the rigid segment.”).
    • Genus Of Antibodies Not Necessarily Described By Description Of Chemical Structure Of Antigen: It is “hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen (Sanofi) I (Fed. Cir. 10/05/17) (rejecting this jury instruction because it erroneously invites jury to conclude that it is enough for the specification to show how to make and use the invention: “In the case of a claim to antibodies, the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine.”) See USPTO Memo. (02/22/18) (under Amgen, “adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.”)
    • Not Every Variation Of Condition Or Disease Should Be Treated As Separate Species For Which Possession Must Be Shown: “Liquidia essentially asks us to treat Group 2 PH as a claimed species within a larger genus (i.e., all five groups of pulmonary hypertension). But analogizing a subset of patients having a variant of a particular disease to traditional genus and species claims is inapt. It would be incorrect to fractionate a disease or condition that a method of treatment claim is directed to, and to require a separate disclosure in the specification for each individual variant of the condition (here, an individual group of pulmonary hypertension patients) in order to satisfy the enablement and written description provisions of 35 U.S.C. § 112, unless these variants are specified in the claims.” United Therapeutics (Fed. Cir. 07/24/23) (aff’g ruling rejecting written-description defense).
  • Must Describe Some Way Of Performing Claimed Method: Broadly claiming a genus of method of regulating certain gene requires a description of some particular mechanism for achieving that result. Ariad Pharm. (Fed. Cir. 03/22/10) (en banc) (rev’g denial of JMOL of jury verdict finding no written description).
  • Disclose Genus Or “Laundry List,” Claim Sub-Genus Or Species: Disclosing a genus (analogs of rapamycin) does not adequately describe claim to a narrower sub-genus (macrocyclic triene analogs of rapamycin) where “nothing in the [Spec.] indicates that the claimed triene analogs might be of special interest,” i.e., “no blaze marks” to that sub-genus. Boston Sci. (Fed. Cir. 06/07/11); Regents Univ. Minn. (Fed. Cir. 03/06/23) (aff’g PTAB anticipation based on sub-genus claims not entitled to ancestor application filing date where ancestor claimed laundry list of possible combinations, not amounting to ipsis verbis written description nor sufficient blaze marks); Gen. Hosp. (Fed. Cir. 05/04/18) (aff’g claimed range lacked written description support. “[W]here a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to ‘immediately discern the limitation at issue in the claims.’” “The disclosure of a range of concentrations from less than 1 × 1011 particles per ml to some unidentified maximum, does not provide written description support for the claimed concentration of ‘about 6.6 × 1011 particles per ml,’ nor does the disclosure of particular discrete values within that range, none of which are the claimed value.”); Purdue Pharma (Fed. Cir. 04/17/19) (aff’g PTAB that patent owner failed its burden to show claimed combination described in provisional where references to two elements of that combination as part of a “laundry list” of possible mixtures, “do not constitute ‘blaze marks’ that indicate or direct that a particular combination should be made ‘rather than any of the many others which could also be made.’”); Progressive Casualty (Fed. Cir. 08/24/15) (non-precedential) (aff’g PTAB decision that claims not entitled to parent’s filing date where parent disclosed producing a rating factor but claims recited a specific example of such a rating factor); Novozymes (Fed. Cir. 07/22/13) (discussing several “disclose genus”/“claim species” precedents; aff’g JMOL of invalidity, after $18 million jury verdict. Priority app. disclosed seven possible parent enzymes, 33 promising amino acid positions for mutations, and 40 possible mutations. These possibilities expressly disclosed each limitation of the claim, namely (1) a parent BSG alpha-amylase enzyme; (2) a substitution at the S239 amino acid position; and (3) increased thermostability at 90°C, pH 4.5, and 5 ppm calcium. But did not satisfy written description because “Taking each claim—as we must—as an integrated whole rather than as a collection of independent limitations, one searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any ‘blaze marks’ that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.”); Purdue Pharma (Fed. Cir. 10/25/00) (claimed concentration ratio above 2 not supported where Spec. had examples above and below 2, did not emphasize that ratio as aspect of invention, and lacked blaze marks to that range of that ratio).

g) relationship to enablement

  • Overlap With Enablement Requirement: While there is some overlap between the written description and enablement requirements (Lizardtech (Fed. Cir. 10/04/05) (“Those two requirements usually rise and fall together.”)), there are differences. Sec. 112 “contains two separate description requirements: a ‘written description [i] of the invention, and [ii] of the manner and process of making and using [the invention’].” Ariad Pharm. (Fed. Cir. 03/22/10) (en banc); see Schriber-Schroth I (U.S. 11/07/1938) (rev’g validity finding based on feature not described in application as filed: “Even if those skilled in the art would have known that a piston with webs which would yield enough laterally to accommodate the constriction of the split skirt under the pressure developed by thermal expansion would work most effectively if the webs were laterally flexible rather than rigid, that was not the invention which Gulick described by his references to an extremely rigid web.”); Purecircle (Fed. Cir. 01/02/24) (non-precedential) (aff’g written description invalidity; “In general the need for extensive trial and error testing argues against a finding of adequate written description,” even if claims enabled by knowledge outside the disclosure). If one of these defenses seems viable, typically assert both.
  • TIPS:

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