BASICS: “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, ….” 35 U.S.C. § 112(1/a). Enablement requires that the disclosure teach PHOSITA to make or carry out (use) the claimed invention without undue experimentation, including disclosing a practical utility for the invention. Rasmusson (Fed. Cir. 06/27/05); seeEdwards Life Sci. (Fed. Cir. 11/13/12) (approving a jury instruction on enablement, and aff’g rejection of enablement defense despite stent/valve not being developed sufficiently for use in humans). “‘A considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance.’” Cephalon (Fed. Cir. 02/14/13) (rev’g bench trial judgment of non-enablement, rejecting expert’s testimony as unsubstantiated, and explaining meaning of “undue” experimentation). The Spec. must enable the “full scope” of the claim. Promega I (Fed. Cir. 12/15/14) (rev’g denial of Summ. J. of non-enablement of open-ended claim in unpredictable field whose full scope was not enabled), reconfirmed Promega II (Fed. Cir. 11/13/17) (on remand from S. Ct.). But, this does not require that each conceivable embodiment within the claim be enabled. “‘That is not to say that the specification itself must necessarily describe how to make and use every possible variant of the claimed invention, for the artisan’s knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability of the art.’ AK Steel (Fed. Cir. 09/23/03).” Chiron (Fed. Cir. 03/30/04). In Sec. 112(1/a), so part of Sec. 120.
Future Technology Need Not Be Enabled But Nascent Technology Must Be: Chiron (Fed. Cir. 03/30/04) distinguishes between routine technology and future technology (neither of which need to be enabled in the Spec.) vs. nascent technology (which must be enabled with “specific and useful teaching”). SeeIn re Hogan (CCPA 07/28/77) (claims encompassing both crystalline polymer and amorphous polymer were sufficiently enabled by ancestor application enabling only crystalline polymer because amorphous polymer was not discovered until after that application was filed).
Must Enable Making The Claim-Recited New Compounds Used For Treatment: “To establish enablement of a claim whereby new chemical compounds are provided for use to treat disease, the application must enable production or synthesis of the new compounds.” Storer (Fed. Cir. 06/21/17) (aff’g PTAB interference decision; applying Wands factors, including named inventor’s post filing efforts toward reduction to practice; provisional application did not enable count).
Good Summary Judgment Prospects: This is a question of law (based on facts) and Summ. J. has been granted often. E.g., Wyeth (Fed. Cir. 06/26/13) (aff’g Summ. J. of no full scope enablement, based on patent owner’s proposed claim construction, where Spec. “discloses only a starting point for further iterative research in an unpredictable and poorly understood field.”); Magsil (Fed. Cir. 08/14/12); Auto. Techs. Int’l (Fed. Cir. 09/06/07) (claims’ recited sensor covered mechanical and electronic sensors; disclosure had long discussion of mechanical, but short mention of electrical; full scope not enabled.); Ormco (Fed. Cir. 08/24/07) (claims require purely automatic operation, not enabled in Spec.); Sitrick (Fed. Cir. 02/01/08) (broad claims covered both movies and video games, but patents did not teach how to implement the claimed “invention” in the context of movies); cf.Streck (Fed. Cir. 01/10/12) (aff’g Summ. J. of sufficient enablement: “Unlike the situation in Automotive Tech., where the electronic sensors differed in structure and operation from mechanical sensors, here, there was unrebutted evidence that true reticulocytes and Ryan’s reticulocyte analogs ‘work in exactly the same way in a hematology control, and are virtually indistinguishable, even to one skilled in the art.’”)
Specification, Not Knowledge Of Skilled Artisan, Must Enable Novel Aspects Of Claims: “‘It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.’ … [R]eliance on a POSA is insufficient to meet the enablement requirement. A patent owner is ‘required to provide an enabling disclosure in the specification; it cannot simply rely on the knowledge of a person of ordinary skill to serve as a substitute for the missing information in the specification.”” Idenix Pharma. (Fed. Cir. 10/30/19) (2-1) (rejecting patent owner’s attempt to limit the number of possible candidates a skilled artisan would explore based on certain knowledge not reflected in the claims or Spec., as “an impermissible end-run around the requirement to enable the full scope of the claim”).
Enablement Must Follow The Steps Disclosed In The Spec.: This aspect of Nat’l Recovery (Fed. Cir. 02/04/99) is promising for seeking Summ. J. on an enablement defense: “If, by following the steps set forth in the specification, one of ordinary skill in the art is not able to replicate the claimed invention without undue experimentation, the claim has not been enabled as required by 112, paragraph 1.” To extent patent owner argues that PHOSITA could have reached the claimed result, the challenger can respond: “only by deviating from the steps recited in the Spec.” Accord Trustees of Boston Univ. (Fed. Cir. 07/25/18) (“But the inquiry is not whether it was, or is, possible to make the full scope of the claimed device—a scope that here covers a monocrystalline growth layer directly on an amorphous layer. The inquiry is whether the patent’s specification taught one of skill in the art how to make such a device without undue experimentation as of the patent’s effective filing date. Viewed in this light, BU’s evidence [that the inventor and others have been able to perform this permutation] is not probative of enablement.”)
Prosecution History May Establish Unpredictable Field: Applicant arguments in prosecution distinguishing specific claimed combinations from prior art helped establish lack of full scope of enablement of claims construed to encompass non-disclosed combinations. Promega I (Fed. Cir. 12/15/14), reconfirmed Promega II (Fed. Cir. 11/13/17) (on remand from S. Ct.).
Lack Of Utility May Show Non-Enablement: one-page Spec. without experimental test results failed to establish therapeutic utility, and thus failed enablement requirement. In re ’318 Patent (Fed. Cir. 09/25/09).
a) which disclosure governs
Unsettled: Unclear whether the asserted priority application or the issued application governs. See discussion under “Written Description.” But either way the relevant date is the effective filing date that is sought. Application (continuation of divisional of two CIPs) “should have been tested for compliance with § 112, first paragraph, ‘as though filed on the date of the prior application’” to which the patent applicant claim priority under Sec. 120, on claim-by-claim basis, even when claim actually not entitled to that date. In re Hogan (CCPA 07/28/77); seePlant Genetic (Fed. Cir. 02/20/03) (“Enablement is determined as of the effective filing date of the patent” (citing In re Hogan); effective filing date here undisputed); Trustees of Boston Univ. (Fed. Cir. 07/25/18) (analyzing enablement as of patent’s asserted effective filing date).
b) enable “full scope” of claim
Full Scope Enablement An “Important Doctrine”: “This important doctrine prevents both inadequate disclosure of an invention and overbroad claiming that might otherwise attempt to cover more than was actually invented. Thus, a patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage.” Patent owner asserted that the open-ended element in claims of causing a “change in the resistance by at ‘least 10%” covered performance gains “up to infinity.” “In sum, this field of art has advanced vastly after the filing of the claimed invention. The specification containing these broad claims, however, does not contain sufficient disclosure to present even a remote possibility that an ordinarily skilled artisan could have achieved the modern dimensions of this art. Thus, the specification enabled a marginal advance over the prior art, but did not enable at the time of filing a tunnel junction of resistive changes reaching even up to 20%, let alone the more recent achievements above 600%.” Magsil (Fed. Cir. 08/14/12) (aff’g Summ. J. of invalidity for lack of full scope enablement); Trustees of Boston Univ. (Fed. Cir. 07/25/18) (rev’g denial of JMOL; no enablement as a matter of law; “BU notes that there is no dispute as to enablement of five out of the six referenced permutations and argues ‘[t]hat is sufficient.’ We disagree. Our precedents make clear that the specification must enable the full scope of the claimed invention.”); Idenix Pharma. (Fed. Cir. 10/30/19) (2-1) (aff’g JMOL of no full-scope enablement; “an enabling disclosure must ‘be commensurate in scope with the claim.’”); Sitrick (Fed. Cir. 02/01/08) (Aff’g Summ. J. of non-enablement: “Because the asserted claims are broad enough to cover both movies and video games, the patents must enable both embodiments.”); Alcon Res. (Fed. Cir. 08/08/12) (in context of construing claim: “When you claim a concentration range of 0.0001-5% w/v (as claim 2), you can’t simply disavow the invalid portion and keep the valid portion of the claim. If everything up to 0.001% w/v is admittedly not enabled, then the entire claim is invalid.”); Creative Kingdoms (Fed. Cir. 12/19/14) (non-precedential) (aff’g invalidity for lack of enablement: “Here, the novelty of the asserted claims includes the use of sensors in combination, and the scope of the asserted claims includes both mechanical and electronic sensors. But the two specifications contain no guidance as to how electronic sensors … can be substituted or added to detect different motions, as required by the asserted claims.”); Enzo IV (Fed. Cir. 07/05/19) (aff’g Summ. J. of non-enablement: claims required “not just a particular structure, but a particular functionality” and the Spec. did not teach “whether the many [potential] embodiments of the broad claims would exhibit that required functionality”; the art was unpredictable and each of the “extremely large number of possible embodiments” would need to be tested to determine if it had that functionality). But seeAlcon Res. (Fed. Cir. 03/18/14) (rev’g full scope enablement invalidity judgment, for failure to make required threshold showing that some experimentation is necessary to practice the claimed methods, as opposed to optimizing their results).
Full Scope Enablement Defense Requires Identifying Some Non-Enabled Embodiment(s): “It is important to consider the quantity of experimentation that would be required to make and use, not only the limited number of embodiments that the patent discloses, but also the full scope of the claim.” Amgen (Sanofi) II (Fed. Cir. 02/11/21) (aff’g JMOL of no enablement of full scope of functionally defined broad class of antibodies with millions of candidates, in an unpredictable field). “Conducting the Wands analysis has routinely involved concrete identification of at least some embodiment or embodiments asserted not to be enabled—including what particular products or processes are or may be within the claim, so that breadth is shown concretely and not just as an abstract possibility, and how much experimentation a skilled artisan would have to undertake to make and use those products or processes.” McRO II (Fed. Cir. 05/20/20) (vacating judgment of no full scope enablement as being too abstract).
Need Not Disclose Working Example Of Every Embodiment Within Claim Scope: Spec. “need not include a working example of every possible embodiment to enable the full scope of the claims.” Bayer (Fed. Cir. 03/01/21) (aff’g jury verdict rejecting enablement defense).
Broad Functional Claim Elements Non-Enabled If Requires Undue Experimentation To Identify Undisclosed Structures That Perform The Function: “While functional claim limitations are not necessarily precluded in claims that meet the enablement requirement, such limitations pose high hurdles in fulfilling the enablement requirement for claims with broad functional language…. We do not hold that the effort required to exhaust a genus is dispositive. It is appropriate, however, to look at the amount of effort needed to obtain embodiments outside the scope of the disclosed examples and guidance.” Amgen (Sanofi) II (Fed. Cir. 02/11/21) (aff’g JMOL of no enablement of full scope of functionally defined broad class of antibodies with millions of candidates: “If the genus is analogized to a plot of land, the disclosed species and guidance ‘only abide in a corner of the genus.’”).
Full Scope Enablement (Or Written Description) Defense Effectively Can Be Won In Claim Construction: At patent owner’s urging, Fed. Cir. construed claims not to be limited to an injector with a pressure jacket, but Spec. enabled only injector with a pressure jacket, so full scope of claim not enabled. Liebel-Flarsheim (Fed. Cir. 03/22/07); cf.Idenix Pharma. (Fed. Cir. 10/30/19) (2-1) (aff’g JMOL of no full-scope enablement based on Wands factors applied to evidence presented to jury, while conceding that claims might be enabled under narrower construction. Based on unappealed claim constructions, “there are billions of potential 2′-methyl-up nucleosides,” or at least “many, many thousands.” “The key enablement question is whether a person of ordinary skill in the art would know, without undue experimentation, which 2′-methyl-up nucleosides would be effective for treating HCV.”); Trustees of Boston Univ. (Fed. Cir. 07/25/18) (rev’g denial of JMOL after jury verdict rejecting enablement defense; no enablement as a matter of law; claim construction sought by patent owner created six permutations of the relationship between two layers in a semiconductor, but Spec. did not enable one permutation that experts agreed was physically impossible using type of methods disclosed in Spec. (“a monocrystalline growth layer formed directly on an amorphous buffer layer”). “Having obtained a claim construction that included a purely amorphous layer within the scope of the claim, BU then needed to successfully defend against an enablement challenge as to the claim’s full scope.”); Synthes (Fed. Cir. 10/29/13) (2-1) (claim construed broadly at plaintiff’s urging, to cover “openings” in an implant, but Spec. disclosed only grooves not slots or channels: aff’d jury verdict claim invalid for lack of written description support); Magsil (Fed. Cir. 08/14/12) (patent owner “advocated for a broad construction of this claim term” that covered large performance gains over prior art; “MagSil’s difficulty in enabling the asserted claims is a problem of its own making.”); Alza (Fed. Cir. 04/26/10) (claimed methods for treating ADHD using a methylphenidate (“MPH”) drug dosage form whose release rate ascends over an extended period of time. Series of apps. included CIP, continuation and provisional. Ancestor app. mentioned non-osmotic and osmotic embodiments but enabled only the latter. Patent owner obtained construction covering both Claims therefore invalid for lack of enablement. “Enablement is determined as of the effective filing date of the patent’s application.”); Promega I (Fed. Cir. 12/15/14) (undisputed claim construction encompassed not only recited reaction but any other larger, more complex multiplex reaction; citing MagSil with approval), reconfirmed Promega II (Fed. Cir. 11/13/17) (on remand from S. Ct.); Convolve I (Fed. Cir. 07/01/13) (non-precedential) (aff’g Summ. J. of no full scope enablement; “claims purport to cover inputs into any and all physical systems, including disk drives”). Cf.Graver Tank (U.S. 02/28/1949) (claim reciting “metallic silicates” invalid where only nine metallic silicates had been disclosed in Spec. and proved operative, and no basis for construing claims to be limited to those nine).
Open-Ended Limitations: open-ended claim limitations, such as “at least …,” particularly when reciting some alleged performance improvement, are well-suited to a full scope enablement challenge. Magsil (Fed. Cir. 08/14/12) (claim recited causing a “change in the resistance by at ‘least 10%’”); Promega I (Fed. Cir. 12/15/14) (claim element “comprising” a combination of three specific elements construed to be open-ended and thus encompassed larger, more complex combinations not enabled by Spec.), reconfirmed Promega II (Fed. Cir. 11/13/17) (on remand from S. Ct.).
Purely Functional (Desired Result) Limitations: USPTO will reject for lack of enablement a claim reciting a “purely functional claim element” with no limitation of structure, whether or not at the point of novelty, unless it triggers Sec. 112, ¶ 6. In re Miyazaki (BPAI 11/19/08) (precedential) (“the claimed ‘sheet feeding area operable to feed …’ is a purely functional recitation with no limitation of structure” and thus unpatentable for lack of definiteness and lack of enablement).
c) undue experimentation
Undue Experimentation (Wands Factors): “determination of whether the requisite amount of experimentation is undue may include consideration of: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Elan (Fed. Cir. 10/02/03) (in context of whether prior art reference is enabling) (citingIn re Wands (Fed. Cir. 09/30/88) (rev’g BPAI rejection of claims for non-enablement)). But need not address each factor. In re Hillis (Fed. Cir. 05/21/12) (aff’g PTO non-enablement rejection). First challenger must show that some experimentation would be necessary to practice the claimed invention. Alcon Res. (Fed. Cir. 03/18/14) (“After the challenger has put forward evidence that some experimentation is needed to practice the patented claim, the factors set forth in Wands then provide the factual considerations that a court may consider when determining whether the amount of that experimentation is either ‘undue’ or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out.”); Vasudevan Software (Fed. Cir. 04/03/15) (rev’g Summ. J. of no enablement where some Wands factors genuinely disputed; difficulty developing commercially acceptable embodiment not dispositive). SeeIdenix Pharma. (Fed. Cir. 10/30/19) (2-1) (aff’g JMOL of no full scope enablement, based on applying each Wands factor to evidence before jury).
Patent Applicants’ Difficulty Or Failure To Implement Disclosed Technique Is Strong Evidence Of Non-Enablement: “If an inventor attempts but fails to enable his invention in a commercial product that purports to be an embodiment of the patented invention, that is strong evidence that the patent specification lacks enablement.” Ormco (Fed. Cir. 08/24/07) (aff’g Summ. J. of no enablement); Convolve I (Fed. Cir. 07/01/13) (non-precedential) (aff’g Summ. J. of no full scope enablement based on inventor testimony that it took him nine years to fully implement the invention in disk drives); Taylor (2018-1047) (Fed. Cir. 04/03/20) (non-precedential) (aff’g Summ. J. in Sec. 145 review of non-enablement rejection of claims, relying in part on applicant’s admission that he was waiting for other developments). But, Spec. need not enable most efficient commercial embodiment. Transocean (Fed. Cir. 08/18/10) (rev’g Summ. J. of invalidity for non-enablement). Evidence that patent applicants engaged in arguably undue experimentation to implement claimed invention is relevant to enablement even if those efforts occurred after the priority date sought. Amgen (Sanofi) I (Fed. Cir. 10/05/17). Explore in discovery.
Must Teach Skilled Artisan Which Combinations Will Produce The Claimed Functionality: Even if disclosure teaches how to make “the broad range of labeled polynucleotides covered by the claims,” it fails to teach which combinations will provide the claimed functionality. Enzo Life Sciences (Fed. Cir. 07/05/19) (aff’g Summ. J. non-enablement; in highly unpredictable art, with tens of thousands of possible embodiments, sparse Spec. fails to teach “whether the many embodiments of the broad claims would exhibit that required functionality.”); Wyeth (Fed. Cir. 06/26/13) (aff’g Summ. J.; would have required undue experimentation to determine which compounds in the claimed class, with at least tens of thousands of candidates, would have the required functionality).
d) teaching away
Teaching Away May Show Non-Enablement: If a Spec. teaches away from a substantial portion of the claim, there is no enablement. AK Steel (Fed. Cir. 09/23/03) (claims construed to “read on steel strips containing either a Type 1 or a Type 2 aluminum coating,” but Spec. admitted its technique would not achieve claimed result with a Type 1 coating: “We have discovered this [Type 1] aluminum coating metal does not wet well with ferritic chromium alloy steel, even when using the hydrogen protective atmosphere. . . . Commercially pure hot dip aluminum coatings, otherwise known as Type 2 in the industry, are preferred for our invention.”). But seeCallicrate (Fed. Cir. 10/31/05) (a disclosure in background section sufficient for enablement even though the patent criticized it, stating “disparaging remarks in a background section or remarks characterizing the prior art as less effective do not remove those disclosures as enabling references.”)
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