United States: In re Ethicon: Connecting Seemingly Unrelated Dots May Support An Obviousness Conclusion

Composition claims are often rejected as obvious over the combinations of prior art referenced, that separately claim the ingredients of the claimed combination. Moreover, often the disclosure of the claimed ingredients is in the context of different chemical applications. In such cases, the obviousness determination frequently turns on whether one of ordinary skill in the art would have been motivated to combine the references to arrive at the claimed invention with a reasonable expectation of success. The inquiry is highly factual and can lead to different results, depending on the perspective of the fact finder. The Federal Circuit opinion in In re Ethicon —and Judge Newman's dissent—illustrate the difficulty of this inquiry. 844 F.3d 1344, 1354 (Fed. Cir. 2017).

Ethicon, Inc. ("Ethicon") owns U.S. Patent No. 7,591,844, which relates to drug-eluting stents, and methods for maintaining drugs on them. In relevant part, the claims are directed to "[a] device for intraluminal implantation in a vessel comprising a balloon-expandable stent and a pharmaceutical agent-containing coating, said coating comprising a biocompatible polyfluoro copolymer that comprises about eighty-five weight percent vinylidinefluoride [VDF] copolymerized with about fifteen percent hexalfluoropylene [HFP] . . . ." See '844 patent col. 37, l. 59-col. 38, l. 3. (Emphasis added). Ethicon sued Boston Scientific SCIMED ("Boston Scientific") and Abbott Laboratories ("Abbott") for infringement. In re Ethicon, 844 F.3d at 1354. Boston Scientific and Abbott filed separate requests for inter partes reexamination of the '844 patent. The Patent Office granted the reexamination requests and merged the proceedings. Id. In reexamination, the examiner rejected the relevant claims as obvious over, inter alia, U.S. Patent Nos. 5,824,048 ("Touch"), 4,816,339 ("Tu"), and 3,178,399 ("Lo").  Id.

Tuch, the primary reference, is generally directed to polymer coated drug-eluting vascular stents and names hundreds of monomers encompassing thousands of polymers and copolymers that may all be usable for vascular stents in various conditions. Id. at 1353 (Newman J., dissenting). Tuch, however, not disclose the specific copolymer claimed in the Ethicon patent. And although the list in Tuch discloses one of the monomers of the claimed copolymer (VDF), the other known monomer, HFP, is not mentioned. Id. Tu, in turn, describes a multilayered "suturable vascular implants" having "improved luminal hydrophobicity, compliance, strength and elasticity." Id. at 1355 (emphasis added).  The first layer is made of poly(tetrafluoroethylene), the second layer is "a mixture of poly(tetrafluoroethylene) and elastomer," and an optional third layer is made of "elastomer." Id. Tu states that the elastomer may be selected from a diverse group of polymers and copolymers, and VDF and HFP were listed among this list. Id. (citing to Tu, col. 4, ll. 30-39.). The Examiner relied on Tu "for teaching of a medical device comprising VDF:HFP," and further  relied on Lo to teach the VDF:HFP comonomer ratios claimed in the Ethicon patent. Id. at 1357. The Examiner also found unpersuasive Ethicon's evidence of objective indicia of non-obviousness. See id.

The Board affirmed the Examiner's rejection. Id. at 1348. The Board found that the primary reference's teachings would not have limited a skilled artisan to the explicitly listed polymers or dissuaded a skilled artisan from selecting a VDF copolymer. Id. The Board additionally found that the primary reference discloses "a problem with coatings with low elasticity," and that biocompatibility and elasticity are "useful" characteristics for the polymer in its stent coatings and that, therefore, one of ordinary skill in the art would have reasonably sought materials with high elasticity to avoid the problem when the stent is expanded." Id. Among other things, the Board agreed that Tu, one of the secondary references, teaches that VDF:HFP copolymer possesses the useful properties of biocompatibility and elasticity taught by Tuch. Id. The Board similarly agreed that Lo teaches that the claimed monomer ratio "is advantageous with respect to flexibility, elasticity, extensibility, tensile strength, and reverse elongation." See id. The Board agreed with the Examiner that Ethicon's evidence of nonobviousness was not entitled to substantial weight. Id.

On appeal, Ethicon first argued that Tuch never suggested that the elasticity of the polymer itself is an important characteristic and that it, in fact, taught away from using non-bioabsorbable coatings (such as VDF:HFP) by recommending bioabsorbable polymers. Id. The court rejected Ethicon's argument finding that Tuch teaches that elasticity is a useful polymer characteristic and that coatings with low elasticity are problematic. Id. at 1350. Second, Ethicon argued that Tu is directed to medical devices, other than stents, and teaches away from allowing an elastomeric polymer such as VDF:HFP to be in contact with blood. Id. at 1351. The court also rejected this argument, finding that Tu teaches that its invention has a "very broad application in biomedical devices, such as ... heart valve leaflets," Id. Third, Ethicon argued that Lo is decades old (over 50 years old), nonanalogous art directed to harsh industrial applications, as opposed to medical or biological applications, and provides no motivation to combine its teachings with the teachings of Tuch or Tu (dealing with implantable medical devices). Id. Thus, Ethicon essentially argued that the Board relied on impermissible hindsight and failed to provide any reason why one of ordinary skill in the art would have combined the prior art references to create the claimed invention.  Id. The court rejected this argument and determine that substantial evidence supports the Board's finding that Lo's teachings are at least "reasonably pertinent to the particular problem with which the inventors is involved," and stated that the mere age of a reference does not undermine the Board's otherwise proper reliance on it. Id.

The Court also rejected Ethicon's argument that the Board erred by discounting its proffered objective indicia of nonobviousness, because Ethicon relied solely on its expert's conclusory testimony to support its allegations. Id.

Judge Newman dissented concluding that there was no motivation to combine the references without hindsight and finding that the Board erred in declining to consider Ethicon's evidence of copying, commercial success, and medical industry acclaim. Id. at 1353. Judge Newman found that the main reference's omission of the specific copolymer claimed from the thousands of polymeric and other potential stent materials was problematic. According to Judge Newman, "the breadth of these choices and the numerous combinations indicate that these disclosures would not have rendered the claimed invention obvious to try." Id. at 1354 (citing LeoPharma Prods., Ltd. v. Rea, 726 F.3d 1346, 1356–57 (Fed. Cir. 2013)). Judge Newman further disagreed with the Board's combination of the references to arrive at the claims because the references failed to provide motivation to select specific polymer and monomer ratio claimed by Ethicon. See id.

According to Judge Newman, the Board merely collected the elements of Ethicon's patent claims from assorted sources, and improperly placed them in the template of Ethicon's patent. See id. at 1357(citing to Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985) ("The invention must be viewed not with the blueprint drawn by the inventor, but in the state of the art that existed at the time.").

Judge Newman also took issue with the Board's refusal to consider the evidence of superior properties and commercial success presented by Ethicon. The Board, for example, declined to consider the evidence without identifying what it would consider to be an acceptable prior art comparison. Id. To Judge Newman, the Board's refusal to consider this evidence, instead criticizing the "absence" of comparisons with some undefined prior art, is untenable. Id.

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
23 Sep 2018, Seminar, Chicago, United States

Finnegan is a sponsor of the Intellectual Property Owners Association Annual Meeting, supporting the Women in IP Networking Brunch.

26 Sep 2018, Webinar, Washington, DC, United States

This latest series of webinars will explore emerging trends in the changing intellectual property (IP) legal environment in Europe and the United States.

26 Sep 2018, Webinar, Washington, DC, United States

This latest series of webinars will explore emerging trends in the changing intellectual property (IP) legal environment in Europe and the United States.

 
In association with
Related Topics
 
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