United States: Implicit Redefinition Of Claim Scope

Although "the words of a claim are generally given their ordinary and customary meaning," Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1365-67 (Fed. Cir. 2012), if the specification reveals "a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess[,] . . . the inventor's lexicography governs," Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc).  The Federal Circuit has recognized that determining when a patentee is acting as his own lexicographer can be difficult because "the distinction between using the specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice."  Id. at 1323; see also Bell Atl. Network Servs., Inc. v. Covad Commc'ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001).  Recently, in SkinMedica, Inc. v. Histogen, Inc., No. 2012-1560 (Fed. Cir. Aug. 23, 2013), the Federal Circuit revisited many of its claim-construction principles, taking a close look at how to determine when a patentee has chosen to be his own lexicographer. 

At issue in SkinMedica were U.S. Patent Nos. 6,372,494 ("the '494 patent") and 7,118,746 ("the '746 patent"), owned by SkinMedica.   The '494 and '746 patents contain claims related to methods for producing pharmaceutical compositions containing "novel conditioned cell culture medium compositions" and uses for those compositions.  SkinMedica appealed the district court's construction of the claim term "culturing . . . cells in three-dimensions."  The specifications of the '494 and '746 patents refer at several points to methods of culturing cells in two dimensions, using microcarrier beads, and in three dimensions.  SkinMedica argued that the ordinary meaning of "culturing cells in three dimensions" includes growing cells using beads, which was the method allegedly used by the accused infringer Histogen, and that the district court should have interpreted the claim term according to this ordinary meaning.  The district court, however, held that, based on statements made in the specification and during the prosecution history, the patentee acted as his own lexicographer and narrowed the scope of "culturing . . . cells in three-dimensions" by excluding the use of beads. 

In order to determine whether a patentee has, in fact, chosen to be his own lexicographer and use terms in a manner other than according to their ordinary meaning, the court must examine the available intrinsic evidence.  See Bell Atl., 262 F.3d at 1268.  A court need not find an explicit redefinition of a claim term in order to hold that the ordinary meaning of the term does not apply.  Id.  Instead, a claim term may be clearly redefined by implication such that the meaning may be "found in or ascertained by a reading of the patent documents."  Id. (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582, 1584 n.6 (Fed. Cir. 1996)).  The Court noted in Vitronics, for example, that when a patentee uses a claim term throughout the entire patent specification in a manner consistent with only a single meaning, he has defined that term "by implication."  Id.  After a thorough analysis, that is precisely what the Court in SkinMedica concluded the patentees did through the consistent differentiation of beads from cells grown in three dimensions.

First, the Court analyzed the patentee's use of disjunctives, such as "or" and "as opposed to," to differentiate cells grown in three dimensions from cells grown on beads in several instances in the specification and prosecution history.  The Court analyzed the following passages in the specification:

  • "Cell lines grown as a monolayer or on beads, as opposed to cells grown in three-dimensions, lack the cell-cell and cell-matrix interactions characteristic of whole tissue in vivo." 
  • "The cells are cultured in a monolayer, beads (i.e., two dimensions) or, preferably, in three-dimensions."
  • "The cells may be cultured in any manner known in the art including in monolayer, beads or in three-dimensions . . . ."

The Court found that the use of the disjunctive phrase "as opposed to" makes it clear that the patentee considered cells grown on beads to be different and distinct from cells grown in what is considered to be three dimensions.  Similarly, relying on precedent, the Court found that the word "or" plainly designates that a series describes alternatives, and that SkinMedica's use of the word "or" distinguishes beads from cells grown in three dimensions.  See Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326 (Fed. Cir. 2001).  Thus, the Court found that because these distinctions are consistent with the remainder of the specification, they constitute an implicit redefinition of the terminology.

Second, the Court analyzed language in the specification and prosecution history distinguishing beads from cells grown in three dimensions, such as:

  • "Conventional conditioned cell culture medium, medium cultured by cell-lines grown as a monolayer or on beads, is usually discarded or occasionally used in culture manipulations such as reducing cell densities."
  • "Culturing cells in three-dimensions results in the production of a conditioned medium having a different chemical composition than that of cells cultured by conventional means."

The Court relied upon prior precedent as it reasoned that emphasizing a particular attribute of the invention can operate as a disclaimer of claim scope.  See, e.g., SafeTCare Mfg. Inc. v. Tele-Made, Inc., 497 F.3d 1262, 1269-70 (Fed. Cir. 2007).  In SafeTCare, the Federal Circuit found that, because the specification repeatedly emphasized its invention as applying pushing forces, not pulling forces, the inventor made it clear that this attribute of the invention is important in distinguishing the invention over the prior art and, in effect, disclaims the use of pulling forces.  Similarly, in Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1333 (Fed. Cir. 2009), the Court emphasized that "[w]here the general summary or description of the invention describes a feature of the invention . . . and criticizes other products . . . that lack that same feature, this operates as a clear disavowal of these other products . . ."  (citing Astrazeneca AB v. Mut. Pharm. Co., 384 F.3d 1333, 1340 (Fed. Cir. 2004)).

Applying these principles in SkinMedica, the Court found that statements in the specification and prosecution history repeatedly distinguished the three-dimensional cultures from cell-lines grown using beads to demonstrate the novelty of the medium produced by three-dimensional cultures.  Consistent with prior case law, the Court found that this emphasis on a particular mode of operation, especially to avoid prior art, operated as a disclaimer of the otherwise broad scope of the claim term at issue.  See SafeTCare, 497 F.3d at 1270.  The Court relied on SkinMedica's consistent emphasis of this distinction between beads and three dimensions throughout the specification and prosecution history to find that the distinction was, in effect, a redefinition by implication of the claim term "culturing . . . cells in three dimensions."  See Bell Atl., 262 F.3d at 1271-73.

Lastly, the Court analyzed SkinMedica's use of "i.e." throughout the specification.  The Court found that the inventors use of the phrase "i.e." throughout the specification, about twelve times in total, to introduce an explanation or definition of a word or phrase, demonstrated the inventors' intent to define "beads" when they wrote "beads (i.e., two dimensions)."  This is consistent with the Court's prior holding in Edwards Lifesciences, in which the Federal Circuit held that a patentee's use of "i.e." in the specification "signals an intent to define the word to which it refers."  582 F.3d at 1334.¹

The SkinMedica case serves as yet another reminder that statements made both in the specification and during prosecution must be carefully considered so as not to later limit claim scope.  Special attention should be paid to the use of words such as "or" and "as opposed to" when drafting specifications to ensure that they are only used when a distinction is required.  The Federal Circuit has also reemphasized that "i.e." is typically used to define a term, regardless of where in the specification it is used.  Practitioners should use this term sparingly, and consciously, in patent applications, making sure to use it only when intended to provide a definition.  Being aware of these potential pitfalls will assist in avoiding unintentional disclaimer of claim scope.

Footnotes

1. Despite SkinMedica's various arguments that the Court's definition was inconsistent with references cited on the face of the patents or within the patents, and with its expert's testimony, the Court declined to give much weight to this extrinsic evidence in light of the consistent and repetitive redefinition of the claim term through the intrinsic evidence, including the prosecution history and the specification.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Events from this Firm
14 Nov 2018, Webinar, Washington, DC, United States

Finnegan’s 2018 webinar series addresses challenges across the IP landscape in the United States. The series starts with one of the fundamentals—proving or disproving obviousness. The panelists will address what works and what doesn’t before U.S. Patent and Trademark Office (USPTO) examiners, before the Patent Trial and Appeal Board (PTAB), and before the courts.

14 Nov 2018, Workshop, London, UK

Finnegan partner Leythem Wall will consider European claim drafting strategy and lead the Chemical Workshop during a two-day course, hosted by Management Forum.

14 Nov 2018, Speaking Engagement, Washington, DC, United States
Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions