United States: Knowledge Of A Goal Does Not Render Its Achievement Obvious

In Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, Nos. 12-1485, -1486, -1487 (Fed. Cir. Dec. 30, 2013), the Federal Circuit reversed the Board's decision that claims 10 and 12 of U.S. Patent No. 6,610,545 ("the '545 patent") were obvious; vacated and remanded the Board's decision that the claims of U.S. Patent No. 6,833,252 ("the '252 patent") were obvious; and dismissed as moot the Board's decision regarding U.S. Patent No. 7,309,605 ("the '605 patent").

Institut Pasteur and Universite Pierre et Marie Curie (collectively "Pasteur") own the '605, '545, and '252 patents, which claim methods and tools for inserting or deleting genes at targeted locations in the chromosomes of living cells ("gene targeting") using group I intron encoded endonucleases ("GIIE endonucleases").  Precision BioSciences, Inc. ("Precision") requested inter partes reexamination of each patent, and the examiner rejected a number of Pasteur's claims as obvious during reexamination.  The Board affirmed the examiner's rejections, and Pasteur appealed.  While the appeal was pending, the involved patents expired.

The Court dismissed as moot the appeal relating to the '605 patent, finding that Pasteur substantively narrowed the scope of claim 14 during reexamination by amending the claim to recite that the targeted DNA was "chromosomal."  The Court rejected Pasteur's argument that the scope was unchanged because the claim was already limited to chromosomal DNA.  Specifically, Pasteur argued that claim 14 was limited to "chromosomal DNA" even before the amendment because it recited that the targeted DNA undergoes homologous recombination with a newly introduced plasmid whose sequence is "homologous to the sequence of [a] chromosome."  Slip op. at 13 (alteration in original) (citation omitted).  The Court rejected this reasoning, finding that the newly introduced plasmid may be homologous to both chromosomal and nonchromosomal DNA, and, therefore, the original claim did not exclude homologous recombination in nonchromosomal DNA.  Therefore, the Court found that the amendment limiting the claims to chromosomal DNA changed the scope of the claims.  Because under 37 C.F.R. § 1.530(j) and (k), the PTO cannot issue an amended claim for an expired patent if the amendment substantively changes the claim's scope, the Court dismissed Pasteur's appeal relating to the '605 patent as moot.

The Federal Circuit next considered the Board's findings of obviousness with regard to claims 10 and 12 of the '545 patent.  The Court found that two of the cited references (Bell-Pedersen and Quirk) disclosed gene transfer into nonchromosomal DNA in prokaryotic cells, and agreed with the Board that the key issue was whether the relevant skilled artisan—after reading these two references—would have expected that a GIIE endonuclease would successfully promote targeted gene transfer into the chromosomal DNA of eukaryotic cells, and thus had good reason to pursue that possibility.  The Court held that the Board made prejudicial errors by making factual determinations about the prior art that were not supported by substantial evidence, and by failing to give proper consideration to at least two categories of evidence:  (1) teachings in the prior art that targeting a cell's chromosomal DNA could be toxic to the cell; and (2) industry praise and licensing of Pasteur's invention.

First, the Court found that the Board erred in finding that the Frey and Dujon references showed that a GIIE endonuclease cleaved yeast chromosomal DNA when expressed in yeast cells.  "Because no other references identified by the Board show a GIIE endonuclease cleaving chromosomal DNA in a eukaryotic cell, its errors were highly material to whether the '545 patent claims would have been obvious."  Id.  at 17.

"[T]he expectation-of-success analysis must match the highly desired goal, not switch to a different goal that may be a less challenging but also less worth-while pursuit."  Slip op. at 18 (citing KSR Int'l Co.v. Teleflex Inc., 550 U.S. 398, 421 (2007)).

The Court then found that the Board compounded its erroneous findings by ignoring teachings that targeting a GIIE endonuclease to chromosomal DNA in a living cell could be highly toxic.  The Court explained that the Board identified no reason at all that a skilled artisan would have pursued a method toxic to cells.  The Federal Circuit found that instead, the Board relied on the interest stated by the Old reference that "[i]t would be a great advance if such alterations could be engineered into copies of a chosen gene in situ within the chromosomes of a living animal cell."  Id. at 18 (alteration in original) (citation omitted).  The Court cautioned that "knowledge of the goal does not render its achievement obvious."  Id. (quoting Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008)).  The Court stated that "without a sound explanation for doing otherwise, which is not present here, the
expectation-of-success analysis must match the highly desired goal, not switch to a different goal that may be a less challenging but also less worth-while pursuit."  Id. (citing KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)).

Regarding objective indicia of nonobviousness, the Federal Circuit held that the Board erred by too finely parsing Pasteur's evidence of industry licensing and by dismissing Pasteur's evidence of praise based on a misreading of the prior art.  With regard to licensing, the Court explained that the Board rejected the evidence of licensing because the declaration by the inventor and exclusive licensee "did not establish that the third parties specifically licensed the patent family to gain access to the subject matter claimed in the '545 patent, rather than other technology described in the patent but not claimed or claimed in related patents."  Id. at 20 (citation omitted).  The Court found that theoretical possibility does not undermine the strong probative value of the licensing of the '545 patent, stating that "[t]he central success described in the patent is the one prior art hoped for and is captured in the claims at issue."  Id.

With regard to industry praise, the Court explained that while the Board acknowledged that Pasteur established a connection between the praise by the industry and the claimed homologous recombination step, the Board found that the step was possessed by the prior art and therefore not a proper basis to rebut the prima facie case of obviousness.  The Federal Circuit, however, found that under a correct reading of the Dujon reference, the step was not shown.  Thus, the Court held that industry praise, like others' licensing of Pasteur's invention, provided probative and cogent evidence that one of ordinary skill in the art would not have reasonably expected that a GIIE endonuclease could successfully modify chromosomal DNA in eukaryotic cells.  The Federal Circuit thus reversed the Board's rejection of claims 10 and 12 of the '545 patent.

Turning to the '252 patent, the Court noted that its disposition follows from its discussion of the '545 patent.  The '252 patent claims recite a recombinant mammalian chromosome comprising a GIIE endonuclease recognition site, which the Federal Circuit explained was a first step to practicing the method recited by claims 10 and 12 of the '545 patent.  In vacating the Board's conclusion and remanding to the Board for reconsideration, the Federal Circuit explained that the Board identified only a single reason that one of ordinary skill in the art would have attempted to make a recombinant chromosome containing a GIIE endonuclease recognition site:  to apply the homologous recombination method disclosed by the Bell-Pedersen and Quirk references to chromosomal DNA in mammalian cells.  The Court held that this reason was insufficient to support a determination of obviousness, for the reasons discussed in connection with the '545 patent.

The Federal Circuit explained that the Board never considered whether other motivations would have made the chromosome claimed by the '252 patent obvious.  Specifically, the Board did not make a finding about whether a skilled artisan would have introduced a GIIE endonuclease recognition site into a mammalian chromosome even without reasonably expecting its successful use for the site-directed insertion of DNA.  Although mentions were made at oral argument about other uses for such recombinant chromosomes, the Court cautioned that "obviousness is determined at the time the invention was made, so current uses for the recombinant chromosomes, without more, would not establish a sufficient motivation at the time of invention."  Id. at 24 (citation omitted).  Finally, regarding objective evidence of nonobviousness, the Court held that the use of the '252 patent claims as a necessary first step for a method that others in the industry licensed, praised, and copied, does not demonstrate that they did so because of that first step.  The Court thus vacated the Board's conclusion for the '252 patent and remanded for further consideration.

Judges:  Newman, Clevenger, Taranto (author)

[Appealed from Board]

This article previously appeared in Last Month at the Federal Circuit, January, 2014

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
17 Nov 2018, Conference, Washington, DC, United States

Finnegan partner Clare Cornell will present “Covert Trademark Use in the Internet: Licit or Illicit” at the Asian Patent Attorneys Association Conference.

20 Nov 2018, Webinar, Washington, DC, United States

As part of Strafford Publications’ webinar series, Finnegan attorneys Tom Irving, Josh Goldberg, and Cory Bell will analyze Patent Trial and Appeal Board denials and partial denials, offering take-home lessons applicable in

21 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.

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