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Patent applicants and their representatives are encouraged to seek broad claims in order to capture very broad patent rights. However, one can go too far and break out of a very important constraint imposed by the patent statute: The claim must be enabled in exchange for patent rights. If a disclosure is not sufficient, the claim may be rejected by the U.S. Patent and Trademark Office or later invalidated in post-grant proceeding or litigation. Despite this very real pitfall, the risk associated with broad claims and inadequate disclosure seems often overlooked.
Both 35 U.S.C. §112(a) or pre-America Invents Act 35 U.S.C. §112, first paragraph, provide that "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, and shall set forth the best mode contemplated" by the inventor or joint inventor of carrying out the invention. This provision has been deemed to contain the three separate requirements of written description, enablement and best mode. We are here concerned only about the enablement requirement.
While the lack of enablement death knell usually occurs more often in arts where variations and alternate embodiments are less predictable, such as the chemical, pharmalogics and genetics arts, it also poses a problem in the more predictable arts such as the electrical and mechanical arts. Ultimately, enablement concerns the ability of a person skilled in the art to practice the invention using undisclosed embodiments without undue experimentation, an issue that can arise regardless of the level of predictability associated with a particular art.
Criteria used to assess the existence of undue experimentation are set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988). These nonexclusive criteria include: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
It is useful to consider instances where challenged disclosure have been found sufficiently enabling.
In Engel Industries Inc. v. Lockformer Co.  and Cedarapids Inc. v. Nordberg Inc., the patents were directed to more predictable arts, e.g. ducts and rock crushing, yet arguably lacked information that would be useful in practicing the claimed invention. Despite a limited disclosure, each patent was found enabled. In Engel Industries, the court found a disclosure of something relatively well known such as crimping ducts together did not require further disclosure in order to practice the claimed invention. Likewise, in Cedarapids, the claims were enabled because the specification provided sufficient disclosure to practice the invention on a 7 foot crusher and any optimal settings could easily be ascertained in view of what was known in the art.
In Transocean Offshore Deepwater Drilling Inc. v. Maersk Contractors USA Inc., an apparatus for offshore drilling was enabled because the specification provided two systems for pipe transfer which could with "a trivial modification that would not take a lot of time or engineering effort" be used to construct the claimed invention. In Advanced Fiber Technologies Trust v. J&L Fiber Services Inc. the court found that claims covering to screen plates for use in screening pulps in the pulp and paper industry were enabled based on the single method for engaging plates and that it was not necessary to disclose all "theoretical methods of connecting two components."
Limited disclosures also can be enabling even if the art is considered less predictable. In Amgen Inc. v. Hoechst Marion Roussel Inc., claims directed towards a composition of recombinant erythropoietin and its production were construed more broadly than the example disclosed in the patent to cover after arising technology to make the patented composition. Even though the specification did not disclose the after arising technology, the claims were still enabled because there was sufficient disclosure of one method to make the claimed composition and what was known in the art could fill any gaps in the disclosure.
Johns Hopkins Univ. v. CellPro Inc., is another example where the enablement requirement was satisfied despite disclosing only a single method of making and using the claimed invention. In Johns Hopkins, the claims which were directed to the genus of antibodies that bind to a claimed antigen were enabled because the single method disclosed in the specification had been used to produce over 40 additional antibodies, including that of the defendant.
Other examples where a claim in an unpredictable art was deemed enabled can be found in PPG Indus. v. Guardian Indus. and United States v. Telectronics Inc.
In PPG Indus., the court ruled that even though there was a software error in calculating the ultraviolet transmittance data for examples provided in the specification, the specification nonetheless was found to indicate how to minimize the cerium content while maintaining low ultraviolet transmittance and the claims were therefore enabled.
In Telectronics Inc., the court held one embodiment for bone grow stimulation via stainless steel electrodes was sufficient to enable other variations of the invention because the cost and time required to determine additional dosages and responses did not amount to undue experimentation.
In Cephalon, Inc. v. Watson Pharmaceuticals Inc., the court held that the disclosure of an effervescent agent and acid source in the same tablet or dosage also enabled an effervescent agent and acid source in separate tablets because the formulation for the same tablet/dosage provided in the specification was sufficient guidance to put the ingredients in separate tablets without undue experimentation.
A common thread among these cases is that what the particular patent disclosure arguably lacked was either something relatively well known to persons of ordinary skill in the art or something that could be achieved with undue experimentation.
No Enablement Found
Failures and mistakes also provide useful practice points, some of which are highlighted below.
As one may expect, patent claims for less predictable arts are prone to invalidity, especially when the claims are either drafted or construed too broadly. Recently, in a genetic arts case, Promega Corp v. Life Technologies Corp., claims directed to kits having primers that would co-amplify at least three regions of DNA containing short terminal repeats (STR-loci) were broadly interpreted as an open set to include characterization of unrecited STR loci, the court indicated that unrecited loci were not enabled as it is well known that identifying STR loci multiplexes that will successfully coamplify is a complex and unpredictable challenge, which would require undue experimentation for adding even a single new STR loci, much less an infinite amount.
In Monsanto v. Syngenta, the asserted claim was broadly construed to require the claimed gene to function in any plant cell, including both dicots and monocots, however, the specification lacked adequate disclosure to enable transformation of monocots (which was not known in the art until after the filing date of the patent) and thus, the court found that such transformation would require undue experimentation and was therefore not enabled.
In Alza Corp. v. Andrx Pharmaceuticals LLC, the court held that claims construed to cover both osmotic and non-osmotic dosages were invalid for lack of enablement. In this case, the court found that "the quantity of experimentation, lack of guidance in the specification, absence of working embodiments, and breadth of the claims demonstrates that. ... [the] patent specification fails to enable a person of ordinary skill to make and use nonosmotic oral dosage.
Open-ended ranges are also problematic. In MagSil Corp v. Hitachi Global Storage Technologies Inc., a claim term requiring a tunnel junction of resistive changes of at least 10 percent was not enabled through the full scope of the claim because the specification only disclosed upper limit examples of 11.8 percent, which were not sufficient to permit increased values of resistive changes beyond the set limit without undue experimentation.
Custom parts need good disclosure. In In re Gunn, a disclosure of an electrical circuit apparatus depicted in the drawings by block diagrams with functional labels, was held to be non-enabling because the specification provided no indication as to whether the boxes represented "off the shelf products" or parts made specifically for the claimed system and lacked specific operational details. In Automotive Technologies Int’l. v. BMW of NA Inc., claims broadly construed to cover a side-impact crash sensor with both mechanical and electronic switch assemblies were not enabled because a general description in the specification of an electronic sensor e.g. a boxed figure of an electronic sensor and a few lines of description did not instruct a person having ordinary skill in the art how to make or use an electronic side impact sensor.
In Sitrick v. Dreamworks, the claims were interpreted broadly to encompass a method for a integrating user-generated audio and visual effects into a video game or movie, yet the claims were not fully enabled because the specification failed to fully describe how to integrate user generated audio in movies. In GPNE Corp. v. Apple Inc. the court found that claims related to a two-way paging system which were construed to cover both transmission of signals over single and multiple frequencies were invalid because the specification only "fully described and enabled the invention using multiple frequencies" and testimony showed how a person of ordinary skill could design a system using only one frequency.
Teaching away from a later claimed embodiment is also problematic. In Liebel-Flarsheim Co. v. Medrad, Inc., claims directed to a high-pressure medical injection system were broadly construed to include embodiments both with and without a jacket, the court invalidated the claims based on statements in the specification that taught away from a jacket-less embodiment and testimonial evidence revealed that this embodiment could not have been produced at the time of filing. 
The common theme in these case examples does not correlate to the predictability of the art, but rather, seems to be based on a function of broad claims that cover an undisclosed embodiments which could not be made without undue experimentation.
As seen in the examples above, enablement requirements are not clearly distinguishable between predictable and unpredictable arts as one may expect. What is clear is that claims either drafted or construed broadly run a risk of being invalidated regardless of their field of art.
From a practical standpoint, greater care should be given when drafting patent claims to take into consideration what the claims are intended to cover and whether the disclosure enables the full scope of the claims. That is to say, the drafter should consider how broadly a claim can reasonably be read, and then assess the support in the disclosure or the difficulty in practicing undisclosed embodiments. One cannot rely on the cursory inclusions or mentions of alternate embodiments. If there must be gaps in the specification, one should be certain that these gaps could be filled by a person skilled in the art or routine experimentation. Additionally, both broad and specific embodiments of the invention should be described in the specification to allow for similarly varied claim sets affording a fallback position of a narrower claim in order to avoid losing all claims to §112 enablement issues.
 35 U.S.C. 112 (emphasis added).
 While related, we do not address the sufficiency of disclosure to support claims with clauses reciting means or steps for performing a function. One may find further wisdom in reviewing those cases because recitations to means or steps for performing a function, absent statutory constriction to that disclosed and its equivalents, would seem the ultimately broad recitation of a limitation.
 In re Wands, 858 F.2d at 737.
 946 F.2d 1528 (Fed. Cir. 1991).
 121 F.3d 727, 1997 WL 452801 *3 (Fed. Cir. 1997).
 Engel Inds., 946 F.2d at 1533.
 Cedarapids, 121 F.3d at 727.
 699 F. 3d 1340, 1355-56 ( Fed. Cir. 2012).
 2015 WL 1472015 *18-19 (N.D. N.Y.)
 314 F.3d 1313 (Fed. Cir. 2003).
 Amgen, 314 F.3d at 1324-25.
 Id. at 1335-37.
 152 F.3d 1342 (Fed. Cir. 1998).
 Johns Hopkins, 152 F.3d at 1359-61.
 Id. at 1359; 1360-61.
 75 F.3d 1558 (Fed. Cir. 1996).
 857 F.2d 778 (Fed. Cir. 1988).
 PPG Indus., 75 F.3d at 1564.
 Telectronics, Inc. 857 F.2d at 785-86.
 707 F.3d 1330, 1339-40 (Fed. Cir. 2013).
 773 F.3d 1338 (Fed. Cir. 2014).
 Promega, 773 F.3d at 1348-49.
 503 F. 3d. 1352 (Fed. Cir. 2007).
 503 F.3d at 1362.
 603 F.3d 935, 943 (Fed. Cir. 2010).
 687 F.3d 1377 (Fed. Cir. 2012).
 MagSil Corp., 687 F.3d at 1381.
 537 F.2d 1123 (CCPA 1976).
 In re Gunn, 537 F.2d at 1129.
 501 F.3d 1274 (Fed. Cir. 2007).
 Automotive Technologies Int’l., 501 F.3d at 1282.
 516 F.3d 993 (Fed. Cir. 2008).
 Sitrick, 516 F.3d at 1000-01; see also AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244 (Fed Cir. 2003) (claims invalid because only one of the two embodiments were disclosed).
 2014 WL 1390039* (N.D. Cal. 2014).
 481 F. 3d 1371 (Fed. Cir. 2007).
 Liebel-Flarsheim, 481 F. 3d at 1380.
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This article was first published in Law360 on June 8, 2015. Authored by David R. Metzger, Dentons.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
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