BASICS: If an accused system/process does not literally meet a claim element, but has an equivalent thereto, there may be infringement under the Doctrine of Equivalents (DOE). Equivalents analysis is applied to each claim element separately, not to claim as a whole. Warner-Jenkinson (U.S. 03/03/1997) (unanimous); Eli Lilly (Fed. Cir. 08/09/19) (aff’g equivalents infringement, despite chemical differences between salt used in accused method and that used in claimed method, where product “will accomplish an identical aim, furnishing the same amount of pemetrexed to active sites in the body; in exactly the same way, by diluting a pemetrexed salt in an aqueous solution for intravenous administration.”); UCB (Fed. Cir. 06/24/19) (aff’g equivalents infringement by accused patch having “polyisobutylene adhesive, which is different from the claimed acrylate-based or silicone-based polymer adhesives” where features they have in common relate to claimed function and their “differences do not matter for how the claimed invention works”); Equivalents is evaluated from perspective of a person having ordinary skill in the art (PHOSITA) at time of the alleged infringement, and intent is irrelevant. Warner-Jenkinson (U.S. 03/03/1997) (“If the essential predicate of the doctrine of equivalents is the notion of identity between a patented invention and its equivalent, there is no basis for treating an infringing equivalent any differently from a device that infringes the express terms of the patent. Application of the doctrine of equivalents, therefore, is akin to determining literal infringement, and neither requires proof of intent.”); Amgen (Sandoz) (Fed. Cir. 05/08/19) (aff’g Summ. J. of non-infringement; DOE could not extend patent to cover single-step chromatographic separation where claim recited a sequence requiring three steps; “doctrine of equivalents applies only in exceptional cases”), modifiedAmgen (Sandoz) (Fed. Cir. 09/03/19) (striking “applies only in exceptional cases”)..
Formulation: “This court applies two articulations of the test for equivalence. Under the insubstantial differences test, ‘[a]n element in the accused device is equivalent to a claim limitation if the only differences between the two are insubstantial.’ Alternatively, under the function-way-result test, an element in the accused device is equivalent to a claim limitation if it ‘performs substantially the same function in substantially the same way to obtain substantially the same result.’” Voda (Fed. Cir. 08/18/08) (aff’g jury verdict of equivalents infringement). One DOE formulation is whether the claim element and accused structure/step perform substantially the same claim-recited function (Applied Med. (Fed. Cir. 05/15/06)) in substantially the same way, to achieve substantially the same result. Graver Tank (U.S. 05/29/1950) (aff’g equivalents infringement where accused welding-flux composition used silicate of manganese instead of claim-recited silicate of an alkaline earth metal, but prior art and experts showed that manganese silicates had been used in welding fluxes and the two were substantially identical in operation and result.); Machine Co. (U.S. 1878); Tomita II (Fed. Cir. 03/17/17) (non-precedential) (aff’g judgment of no structural equivalence to means-plus-function element). “An analysis of the role played by each element in the context of the specific patent claim will … inform the inquiry as to whether a substitute element matches the function, way, and result of the claimed element, or whether the substitute element plays a role substantially different from the claimed element.” Warner-Jenkinson (U.S. 03/03/1997); Intendis (Fed. Cir. 05/16/16) (aff’g finding of DOE infringement: accused isopropyl myristate performed substantially the same function as the claimed triglyceride and lecithin); VirnetX (Fed. Cir. 09/16/14) (rev’g jury verdict of DOE; security here not equivalent to encryption). Spec. may or may not evidence the claim element’s function, way or result, in the claimed composition, and court may look to understanding of a skilled artisan (here, the defendant’s representations to the FDA in its ANDA); Choon’s Design (Fed. Cir. 06/24/19) (non-precedential) (aff’g Summ. J. no equivalents infringement where Spec. describes and stresses function performed by claimed structure and accused device lacking that structure does not perform that function, despite expert testimony denying that function is performed by claimed structure). The substantial differences test may be more appropriate for non-mechanical cases than the function-way-result test, because “a compound may appear to be equivalent under the FWR test, but not under the substantiality of the differences test.” Mylan (Fed. Cir. 05/19/17) (comparing both tests in analyzing whether silver oxide and manganese dioxide are “equivalent” in patents claiming methods for preparing a chemical compound, and noting that when compounds are expressly named in claims, “an infringement analysis must not take lightly [their] specific recitation.” “The Supreme Court was surely correct in stating that non-mechanical cases may not be well-suited to consideration under the FWR test. That seems to be particularly true in the chemical arts.”).
Interchangeability At Time Of Infringement May Evidence Equivalency: The known interchangeability between claimed and accused elements at the time of infringement (not when the patent was issued), can be strong evidence of equivalency. Graver Tank (U.S. 05/29/1950); Sprint (Fed. Cir. 11/30/18) (non-precedential) (2-1) (aff’g $140 Million jury verdict based on equivalents infringement, based in part on interchangeability of defendant’s IP card to convert data to IP packets, with claimed ATM interworking multiplexer), modified, Sprint (Fed. Cir. 03/18/19).
Equivalent To PHOSITA: Failure to show equivalents from perspective of PHOSITA entitled accused to JMOL of no infringement. Lighting World (Fed. Cir. 09/03/04).
Changing Order Of Steps May Be Equivalent, or Not: Cadence Pharm. (Fed. Cir. 03/23/15) (aff’g DOE infringement where claimed method first dissolved an active ingredient to form a solution and then deoxygenated the solution, whereas accused process first deoxygenates a solvent and only then adds an active ingredient); Wi-LAN (Fed. Cir. 01/08/16) (changed order of processing led to mathematically identical result but saved 20 transistors out of a few hundred for relevant functionality, which is substantial evidence for jury verdict of no DOE).
Patent On Accused Device Does Not Increase Doctrine Of Equivalents Burden To Clear And Convincing Evidence: Siemens Med. (Fed. Cir. 02/24/11), rehearing denied (Fed. Cir. 06/07/11) (with opinions).
Equivalents Infringement Is The Exception Not The Rule: “Application of the doctrine of equivalents is the exception, however, not the rule, for if the public comes to believe (or fear) that the language of patent claims can never be relied on, and that the doctrine of equivalents is simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims, then claims will cease to serve their intended purpose. Competitors will never know whether their actions infringe a granted patent.” Wallace London (Fed. Cir. 10/17/91) (aff’g Summ. J. no infringement).
a) required evidence
Patentee Must Provide Particularized Testimony And Linking Argument: “A patentee must…provide particularized testimony [“of a person of ordinary skill in the art, typically a qualified expert”] and linking argument as to the ‘insubstantiality of the differences’ between the claimed invention and the accused device or process, or with respect to the function, way, result test when such evidence is presented to support a finding of infringement under the doctrine of equivalents. Such evidence must be presented on a limitation-by-limitation basis. Generalized testimony as to the overall similarity between the claims and the accused infringer’s product or process will not suffice.” Aquatex Indus. (Fed. Cir. 02/27/07) (aff’g Summ. J. of no DOE where patent owner submitted only lawyer argument and deposition testimony on how product worked); Advanced Steel (Fed. Cir. 11/12/15) (aff’g Summ. J. of no DOE where expert’s “substantially the same way” analysis pointed to satisfaction of only other claim elements); Paice (Fed. Cir. 10/18/07) (testimony sufficient); Amgen (Fed. Cir. 09/15/09) (evidence insufficient); Galderma (Fed. Cir. 03/25/20) (non-precedential) (reversing DOE finding where patent owner presented no particularized testimony and linking argument); Eastcott (Fed. Cir. 06/04/14) (non-precedential) (aff’g Summ. J. of no DOE where affidavit conclusory); Gemalto (Fed. Cir. 06/19/14) (aff’g Summ. J of no DOE where testimony not particularized); but seeWCM Indus. (Fed. Cir. 02/05/18) (non-precedential) (rev’g JMOL that had overturned jury verdict finding redesigned product infringing under DOE; there is no requirement for opinion testimony for a finding of equivalence, and in special circumstances it is proper to compare redesigned product to infringing original product).
Intrinsic Evidence Is Primary Source Of Evidence Of Function-Way-Result: To determine the function, way, result of a claimed element, look to the claim and the patent, but if they are silent, look to evidence from those skilled in the art (e.g., as to advantages of the accused design). Stumbo (Fed. Cir. 11/28/07); seePlastic Omnium (Fed. Cir. 12/03/19) (2-1) (aff’g Summ. J. no DOE infringement where accused device provided improvement over feature touted in Spec. as part of the invention).
b) matter of law restrictions
Several Matter Of Law Restrictions On Doctrine Of Equivalents: There are several “matter of law” legal restrictions on DOE, making this defense ripe for Summ. J. Legal restrictions on DOE are for the Court to decide (e.g., on Summ. J. or JMOL) not the jury, even if have underlying factual inquiries and need to consider expert testimony and other evidence. Depuy Spine (Fed. Cir. 06/01/09) (ensnarement issue). These include:
Spec. Disavows Alleged Equivalent: DOE may not recapture subject matter disavowed in the written description. AstraZeneca (Fed. Cir. 09/30/04); Paice (Fed. Cir. 10/18/07) (finding no disavowal in patent’s criticism of the prior art); Cordis (Fed. Cir. 01/07/08) (finding no disavowal in PH’s explicit definition of meaning of a claim term, that was already implied in the patent); Rembrandt Patent (Fed. Cir. 11/22/17) (non-precedential) (aff’g no DOE infringement; DOE cannot recapture what Spec. gave up (i.e., manual initiation of recovery process)); Lexion (Fed. Cir. 08/28/08) (non-precedential) (finding no PHE disclaimer because “disputed statements in the prosecution history are subject to multiple reasonable interpretations, they do not constitute the clear and unmistakable surrender required to trigger prosecution disclaimer.”); Sunbeam Prod. (Fed. Cir. 12/15/10) (“The specification . . . explains what is not the claimed invention, and because that explanation excludes the accused bearings from falling within the reach of the patent, those devices cannot infringe under the doctrine of equivalents.”) (non-precedential).
Claim (As Construed) Specifically Excludes Alleged Equivalent: DOE may not capture what claim (or its construction) “specifically excludes.” “While we have recognized that literal failure to meet a claim limitation does not necessarily constitute a ‘specific exclusion,’ …, we have found ‘specific exclusion’ where the patentee seeks to encompass a structural feature that is the opposite of, or inconsistent with, the recited limitation.” Augme Tech. (Fed. Cir. 06/20/14) (linked code in Web page cannot be substantially same as “embedded code” because construction of “embedded code” specifically excludes linked code; aff’g Summ. J. of no DOE); Enzo III (Fed. Cir. 08/02/17) (non-precedential) (aff’g Summ. J. of no equivalents infringement by “direct” detection based on earlier panel’s construction expressly excluding direct detection from scope of claim: “the concept of equivalency cannot embrace direct detection because it is ‘specifically excluded from the scope of the claims’”); Southco (Fed. Cir. 04/10/15) (non-precedential) (parts not directly attached cannot be equivalent to claimed structure requiring direct attachment, as that is “the very thing that the construction excludes.”); Decisioning (Fed. Cir. 05/07/08) (where construction of “remote interface” “encompasses only publicly-accessible computer equipment that is located remotely from the data processing system,” patent owner is precluded from asserting that those systems infringe under the doctrine of equivalents, as doing so would vitiate an element of the claims — i.e., ‘remote interface’ as construed”); Eastman Kodak (Fed. Cir. 05/20/97) (aff’g no DOE; where claim recites “an inert gas atmosphere” and that was construed to exclude heated air ivo Spec. teaching not to add air, accused method using heated air cannot infringe because “the claim language specifically excludes reactive gases — such as ‘heated air’ — from the scope of the claims”); Athletic Alternatives (Fed. Cir. 01/11/96) (DOE “precluded as a matter of law” where construed claim requires an “intermediate offset distance” which renders accused racket with only two offset distances “specifically excluded from the scope of the claims”); Dolly (Fed. Cir. 02/08/94) (rev’g equivalents infringement decision; “the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims. A stable rigid frame assembled from the seat and back panels is not the equivalent of a separate stable rigid frame which the claim language specifically limits to structures exclusive of seat and back panels.”).
Alleged Equivalent Would Vitiate Claim Element (As Construed): DOE may not effectively eliminate (vitiate) any claim element in its entirety. Hilton Davis II (Fed. Cir. 06/12/97) (en banc) (no vitiation); Bio-Rad (Fed. Cir. 08/03/20) (aff’g no vitiation, “caution[ing] against using labels like ‘antithesis’ in lieu of conducting the proper inquiry of infringement under the doctrine of equivalents”: whether “a negligibly-fluorinated microchannel performs the same function, in the same way, and achieves the same result, as a non-fluorinated microchannel”); Duncan Parking (Fed. Cir. 01/31/19) (aff’g Summ. J. of no equivalents infringement under vitiation doctrine); Power Integrations (Fed. Cir. 12/12/16) (rev’g jury verdict of equivalents; finding a single feedback signal equivalent to claimed two “distinct” feedback signals would vitiate that element where it was the alleged improvement over the prior art); Trading Techs. (Fed. Cir. 02/25/10) (“this rule empowers a court to perform again the standard ‘insubstantial variation’ test for equivalency, but this time as a question of law. Claim vitiation applies when there is a ‘clear, substantial difference or a difference in kind’ between the claim limitation and the accused product.”); Akzo Nobel (Fed. Cir. 01/29/16) (vitiation applies if equivalence theory “renders a claim limitation inconsequential or ineffective”); United Access (Fed. Cir. 04/15/22) (non-precedential) (aff’g Summ. J. no DOE infringement; the theory of infringement embraces a structure that is specifically excluded from the scope of the claims, as construed); Impulse Tech. (Fed. Cir. 12/07/16) (non-precedential) (“The accused hardcoded values, which are abstract, mathematical constructs coding for a physical space that is known only after adaptation of the system, and the claimed “defined physical space,” known prior to adaptation of the system, are essentially the antithesis of one another. Thus, no reasonable jury could conclude that they are equivalents.”). Cf.Deere & Co. (Fed. Cir. 12/04/12) (“Courts should be cautious not to shortcut this inquiry by identifying a ‘binary’ choice in which an element is either present or ‘not present.’”); Edgewell (Fed. Cir. 05/26/21) (rev’g Summ. J. of no DOE (based on vitiation theory) of claim term “annular cover” ivo detailed expert testimony on same function, way and result); Epos Tech. (Fed. Cir. 09/05/14) (same). There is no separate vitiation exception to DOE. Brilliant Instruments (Fed. Cir. 02/20/13) (2-1) (rev’g Summ. J. of no equivalents (based on vitiation theory); vitiation is merely a finding of no equivalents); accordWarsaw I(Fed. Cir. 03/02/15) (aff’g jury verdict of DOE: “jury could find that two enclosing prongs capable of lateral movement and pivoting was equivalent to three enclosing prongs, two of which were capable of lateral movement and pivoting”); Charles Machine (Fed. Cir. 07/26/13). But seeCadence Pharm. (Fed. Cir. 03/23/15) (aff’g DOE infringement; “‘Vitiation’ is not an exception or threshold determination that forecloses resort to the doctrine of equivalents, but is instead a legal conclusion of a lack of equivalence based on the evidence presented and the theory of equivalence asserted”; citing many cases for this).
Prosecution History Estoppel (see below).
Disclosure Dedication (see below).
Ensnarement Of Prior Art (Wilson Sporting Goods) (i.e., scope sought to be reached under DOE, viewed as a hypothetical claim, must be patentable). Legal question for court. Jang (Fed. Cir. 09/29/17). Detailed, post-KSR analysis aff’g trial court finding that DOE hypothetical claim did not ensnare the prior art. Depuy Spine (Fed. Cir. 06/01/09). “An accused infringer seeking to avoid infringement under the doctrine of equivalents on this basis bears the burden of ‘presenting prior art which shows that the asserted range of equivalence would encompass the prior art,” but the patentee bears the ultimate burden of persuasion to show that its claims do not cover the prior art.” Energy Transport (Fed. Cir. 10/12/12); Jang (Fed. Cir. 09/29/17) (aff’g non-equivalents based on ensnarement; patent owner failed its burden to prove patentability of hypothetical claim by failing to present hypothetical claim broader in all respects than actual claim. Hypothetical claim may not be narrower in any respect. Court is not obligated to draft proper hypothetical claim.). But seeGemalto (Fed. Cir. 06/19/14) (aff’g Summ. J. of no DOE where proposed scope of DOE would ensnare prior art microprocessors). “Hypothetical claims extend the actual claim to literally recite the accused product.” Intendis (Fed. Cir. 05/16/16) (aff’g finding of DOE and rejecting defendant’s proposed hypothetical claim as too broad). Hypothetical claim may not narrow the actual claim in any respect. Streamfeeder (Fed. Cir. 04/20/99). “The hypothetical claim analysis is not the only method in which a district court can assess whether a doctrine of equivalents theory ensnares the prior art.” Jang (Fed. Cir. 09/29/17). See generallyIPLaw 360 article (10/24/17) (discussing Jang and ensnarement doctrine).
Literal Claim Already Captures Equivalents: Qualitative measures (e.g., “about”) may bar DOE. In context of this patent, word “about” before a numerical limitation “brought what would otherwise be equivalents of a limitation into the literal scope of the claim, [so] the doctrine of equivalents is unavailable to further broaden the scope of the claim.” Cohesive Tech. (Fed. Cir. 10/07/08); cf.Adams Respiratory (Fed. Cir. 08/05/10) (doctrine of equivalents may apply to numerical ranges, even those stating “at least __.”); Pozen (Fed. Cir. 09/28/12) (aff’g DOE infringement; although “substantially all” is qualitative, its construction based on the Spec. was quantitative (“at least 90%”) so DOE available, and 85% level infringed under DOE).
Foreseeability Of Accused Feature Is Not Per Se Bar To Equivalents Infringement, But Is A Factor: That accused feature was foreseeable at the time of the application is not a bar on DOE. Ring & Pinion (Fed. Cir. 02/19/14). But, “Ring & Pinion does not foreclose consideration of foreseeability of an asserted equivalent as one factor that may, in some cases, help show that the facts cannot support infringement under the doctrine of equivalents.” UCB (Fed. Cir. 06/24/19) (no legal bar to equivalents where Spec. did not tout benefits that would exclude accused feature and record evidence unclear about the applicants’ knowledge of the accused variation when they prosecuted the patent); WM Wrigley (Fed. Cir. 06/22/12) (no equivalents, in part because “the inventors were on notice of the potential interchangeability of WS-23 and WS-3, yet they drafted the claims … narrowly to recite certain N-substituted-p-menthane carboxamides, not a broader category of carboxamides that would include WS-23”).
c) prosecution history estoppel
BASICS: Legal question for court. Jang (Fed. Cir. 09/29/17). Actions before the PTO might bar the patent owner from using DOE to capture the accused technology. The issue normally is whether an amendment (voluntary or not) or argument surrendered originally claimed subject matter, for reasons related to patentability. Argument-based estoppel arises when the applicant makes an argument evincing a “clear and unmistakable surrender” of subject matter. Spectrum Pharm. (Fed. Cir. 10/02/15) (aff’g prosecution history estoppel based on amendment and argument). “To determine whether prosecution-history estoppel applies, ‘the relevant inquiry is whether a competitor would reasonably believe that the applicant surrendered the relevant subject matter.’” Power Integrations (Fed. Cir. 09/20/18). The standard “Festo” (Festo (U.S. 05/28/2002) (unanimous), Festo (Fed. Cir. 09/26/03) (en banc)) analysis for amendments is as follows:
first, did the amendment narrow the literal scope of a claim? Cf.EMD Millipore (Fed. Cir. 09/29/14) (finding PHE; amendment broadened and narrowed, creating presumption of estoppel); Eli Lilly (Fed. Cir. 12/21/20) (non-precedential) (aff’g no prosecution history estoppel because amendment in response to indefiniteness rejection, changing trade name to generic name of same compound, did not narrow scope of claim).
if yes, and no reason is stated in the prosecution history (PH) for the narrowing amendment, there is a rebuttable presumption that it was made for a substantial reason related to patentability, and thus PHE applies. Cf.Warner-Jenkinson (U.S. 03/03/1997) (“place the burden on the patent holder to establish the reason for an amendment required during patent prosecution”); Amgen (Fed. Cir. 01/07/20) (aff’g PHE; dismissing boilerplate statement by applicant 8 months later that Examiner’s amendment was made for reasons other than patentability).
to overcome this presumption, the patent owner can rely solely on evidence in the PH record
if estoppel applies, there is a rebuttable presumption that PHE completely bars application of DOE as to amended claim limitations (i.e., that all territory between the original claim limitation and the amended claim limitation is off limits for DOE (Norian (Fed. Cir. 12/06/05)); seeCobalt Boats (Fed. Cir. 05/31/19) (non-precedential) (rev’g equivalents infringement; where prior art step capable of rotating 90 degrees, to avoid rejection over that prior art amended claim, which originally required no rotation, to require rotating by at least “180 degrees,” and accused product could rotate no more than 179 degrees, equivalents barred by prosecution history estoppel. In particular, “when claims are amended to include a specific numeric boundary, we have held that the patentee cannot later recapture what is beyond that boundary through the doctrine of equivalents.”).
the patent owner may show, however, that it did not surrender the particular equivalent in question by showing that at the time of the amendment, one skilled in the art could not reasonably have been expected to draft a claim that literally encompassed the alleged equivalent.
this may be established by showing that: (1) the alleged equivalent would have been “unforeseeable” at the time of the claim amendment; (2) the objective rationale (as shown in the prosecution history) underlying the amendment bore no more than a “tangential relation” to the alleged equivalent; or (3) there was “some other reason” (e.g., shortcomings of language) why the patentee could not reasonably be expected to have literally claimed the alleged equivalent. This third “excuse” may not be used if the alleged equivalent was in the prior art. SeeHoneywell (Fed. Cir. 04/18/08) (extended discussion of foreseeability and tangential relation, rejecting both and upholding JMOL no infringement); Integrated Tech. I (Fed. Cir. 11/04/13) (PH estoppel not rebutted).
this rebuttal-of-presumption issue presents a question of law for the Court.
Claim Preamble Defines Field Of Invention For Foreseeability Analysis: where claim recited “Pharmaceutical compositions … comprising conjugated estrogens …,” the alleged equivalent “need only to have been known in the field of pharmaceutical compositions” not that it be known to be suitable for use with conjugated estrogens. Duramed Pharm. (Fed. Cir. 07/21/11).
Bar May Arise From Rewriting “Objected To” Dependent Claims: Narrowing may be found from cancelling a broad claim: “the rewriting of dependent claims into independent form coupled with the cancellation of the original independent claims creates a presumption of prosecution history estoppel.” Honeywell (Fed. Cir. 06/02/04) (en banc); Felix (Fed. Cir. 04/10/09).
If Presented As Separate Arguments, Each Distinction Over Prior Art (In PTO) Forms Its Own Estoppel: PODS (Fed. Cir. 04/27/07); Amgen (Fed. Cir. 07/29/19) (aff’g dismissal for failure to state a claim based on prosecution history estoppel where applicants made three separate arguments to distinguish prior art, rather than rely only on combination of distinctions, one of which distinguishes accused products).
Argument Creating Estoppel Need Not Be Most Recent Argument Before Allowance: Amgen (Fed. Cir. 07/29/19) (aff’g dismissal for failure to state a claim based on prosecution history estoppel where applicants made three separate arguments to distinguish prior art, third of which it did not repeat in most recent remarks before allowance, which third argument distinguished accused product, where nothing in final submission “disavows the clear and unmistakable surrender of unclaimed salt combinations”).
Presumption Of Estoppel Attaches Even If Amendment Unsuccessful: Felix (Fed. Cir. 04/10/09).
Argument Does Not Give Rise To Estoppel If Clearly And Expressly Rejected By Patent Office: Galderma (Fed. Cir. 03/25/20) (non-precedential) (aff’g bench trial judgment of equivalents infringement; patent owner’s argument in IPR was not clear and unmistakable surrender of scope precluding DOE because the PTAB “clearly and expressly rejected” the argument).
Bar Rebutted Because Amendment Tangential To Equivalent: Festo bar rebutted where rationale underlying the narrowing amendment bears “no more than a tangential relation to the equivalent in question.” Insituform (Fed. Cir. 10/04/04); Bio-Rad (Fed. Cir. 08/03/20) (aff’g equivalents infringement, where “objectively apparent reason for the amendment was to distinguish fluorinated microchannels from microchannels that had no fluorinated properties,” limitation was no more than tangentially related to accused product with “negligible quantities of fluorine that have no function in the product and do not react with the microchannels,” which accused feature was not disclosed by distinguished prior art reference); Eli Lilly (Fed. Cir. 08/09/19) (aff’g equivalents infringement and that “amendment narrowing ‘an antifolate’ to ‘pemetrexed disodium’ was only tangential to pemetrexed ditromethamine, which is the accused compound,” despite it narrowing an existing claim element); Ajinomoto (Fed. Cir. 08/06/19) (2-1) (collecting cases; aff’g equivalents infringement and ITC finding that presumption of prosecution history estoppel surrendering entire territory of difference between original and amended claim rebutted under “tangential relation” exception where reasons for the narrowing amendment were unrelated to the difference between the literal claim scope and the alleged equivalent accused product); Dakocytomation Calif. (Fed. Cir. 02/28/08) (rev’g Summ. J., finding presumption rebutted under tangential relation argument); Funai (Fed. Cir. 09/01/10) (aff’g that claim term merely tangential to prosecution). But seePharma Tech. (Fed. Cir. 11/22/19) (aff’g no DOE infringement due to amendment and argument based prosecution history estoppel; applicants’ repeated and clear emphasis on added limitations to distinguish prior art defeat tangential relation argument).
May Arise From Prosecution Of Parent Application: Power Integrations (Fed. Cir. 09/20/18) (aff’g refusal to find prosecution history estoppel from arguments in parent prosecution where language of claims differed.)
May Arise From Election Of Claims In Response To Restriction Requirement: Where applicant selects a set of claims in response to a restriction requirement and Sec. 103 rejection, “the determination of whether an amendment was made for purposes of patentability on grounds of obviousness is adjudged from the viewpoint of a person of skill in the field of the invention, and when the issue includes consideration of formalities of patent practice, experience in patent law and procedures is presumed.” Merck (Fed. Cir. 09/03/99) (aff’g Summ. J. prosecution history estoppel barring equivalents infringement); UCB (Fed. Cir. 06/24/19) (aff’g no prosecution history estoppel where election of claims in response to restriction requirement was not related to a patentability rejection or to accused composition.
May Arise From IPR Proceedings: Galderma (Fed. Cir. 03/25/20) (non-precedential) (aff’g bench trial judgment that no argument-based prosecution history estoppel applied based on IPR arguments, but indicating that it could under appropriate circumstances).
Prosecution History Estoppel May Justify Dismissal Of Complaint For Failure To State A Claim: Amgen (Fed. Cir. 07/29/19) (aff’g dismissal for failure to state a claim based on prosecution history estoppel where applicants argued (in remarks and an inventor declaration) to Examiner that prior art did not disclose “particular” claimed salt combinations, and accused product was not particular claimed salt combination).
d) disclosure-dedication restriction
BASICS: There are several ways in which a patent (or its expiration) may dedicate subject matter to the public, immunizing it from a charge of patent infringement, or from a charge of “equivalents” infringement.
Disclosure Of Alternative To Claimed Feature Or Embodiment Bars DOE Reaching The Alternative (“Disclosure-Dedication Doctrine”): A patent disclosing an embodiment or feature (as being in the prior art and/or as being an embodiment of the “invention”) without claiming it precludes coverage of that feature under DOE, even if claimed in a continuation. Johnson & Johnston (Fed. Cir. 03/28/02) (en banc) (but can be claimed in a continuation patent); Eagle Pharm. (Fed. Cir. 05/08/20) (aff’g Rule 12(c) dismissal of complaint asserting DOE infringement of four patents on theory that the ethanol in accused product is insubstantially different from the propylene glycol in the claimed composition, because ethanol disclosed in Spec. as alternative, and did not describe distinct categories of formulations that contain different ingredients and work in different ways; approving trial court disregarding expert declaration); Indivior II (Fed. Cir. 07/12/19) (2-1) (aff’g no equivalents infringement under disclosure-dedication rule: “when a patentee discloses subject matter but does not claim it, the patentee dedicates the unclaimed subject matter to the public and cannot recapture it through the doctrine of equivalents”); Ottah (Fed. Cir. 03/07/18) (aff’g R. 12(b)(6) dismissal of pro se complaint under Iqbal / Twombly; partly because Spec. described “book holder” holding book or camera but claim recites holding book, equivalents infringement not plausible against a mobile camera); CSP Tech. (Fed. Cir. 03/22/16) (non-precedential) (aff’g Summ. J. of no DOE, after first limiting claim to one of two embodiments, holding that disclosure of unclaimed second embodiment barred DOE, noting that continuation patent omitted the narrowing claim term); PSC (Fed. Cir. 01/20/04) (“Because PSC dedicated plastic clips to the public by explicitly claiming only clips made of metal while specifically disclosing that the prior art included clips made of plastic, we affirm [Summ. J. of non-infringement].”); Zircon (Fed. Cir. 10/05/11) (non-precedential) (Spec. disclosed two embodiments; claims recited first and defendant used second; Summ. J. of no infringement affirmed). Intent not to claim the disclosed alternative is irrelevant; and issue is a matter of law. Toro (Fed. Cir. 09/13/04).
Disclosure Dedication Rule Extends To Disclosures In Priority Application: Also applies to disclosure of (unclaimed) alternative in a priority application that was omitted from the patent’s application. Abbott Labs. (Fed. Cir. 05/18/09).
Disclosure Of Genus May Not Disclose (And Dedicate) Each Species: “Subject matter is considered disclosed when a skilled artisan ‘can understand the unclaimed disclosed teaching upon reading the written description,’ but not ‘any generic reference . . . necessarily dedicates all members of that particular genus.’” Eli Lilly (Fed. Cir. 08/09/19) (aff’g equivalents infringement and no disclosure dedication despite accused product being within genus identified in Spec.)
To Be Dedicated, Must Be Disclosed As Alternative To Claimed Subject Matter: Disclosure must expressly or implicitly identify unclaimed embodiment as alternative to claimed embodiment. CSP Tech. (Fed. Cir. 03/22/16) (non-precedential); SanDisk (Fed. Cir. 10/09/12) (rev’g trial court disclosure-dedication based judgment of no DOE as to two claim limitations: the alternative must be disclosed with specificity and the patent must identify it as an alternative to the claimed approach). “The disclosure-dedication doctrine does not require the specification to disclose the allegedly dedicated subject matter in an embodiment that exactly matches the claimed embodiment,” but instead “requires only that the Spec. disclose the unclaimed matter ‘as an alternative to the relevant claim limitation’” that serves same purpose as recited in claim. Eagle Pharm. (Fed. Cir. 05/08/20) (aff’g Rule 12(c) dismissal of complaint asserting DOE infringement).
Disclosure Dedication Extends to Subject Matter Disclosed As Prior Art: PSC (Fed. Cir. 01/20/04): includes subject matter disclosed as prior art, but not claimed.
e) relationship to sec. 112(6/f)
DOE vs. Sec. 112(6/f) Structural Equivalents: Comparison of Sec. 112(6/f) structural equivalents to DOE equivalents, explained: Frank’s Casing (Fed. Cir. 11/30/04); and in Minks (Fed. Cir. 10/17/08). Sec. 112(6/f) equivalents evaluated as of time of issuance; DOE equivalence evaluated at time of infringement; and Sec. 112(6/f) equivalents requires same function; DOE allows equivalent function. Ring & Pinion (Fed. Cir. 02/19/14) (no foreseeability exception applies to DOE for a means-plus-function element or any other element).
DOE On Sec. 112(6/f) Element: Aff’g no infringement where accused product’s function not equivalent to function in means plus function element. Pennwalt (Fed. Cir. 11/06/87) (en banc).
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