TELEFLEX INCORPORATED In
Medtronic filed two inter partes review ("IPR") petitions asserting that claims 1, 2, 4, 5, and 7-14 of the '413 patent are unpatentable. The PTAB issued a decision in both cases that the references do not anticipate nor render obvious the claims of the '413 patent, to which Medtronic appealed the obviousness assertions.
In the decision of the IPRs, the PTAB construed claim 1 to require performing the claimed steps in the recited order. The PTAB relied on this determination to conclude that claim 1 of the '413 patent was not obvious over some of the cited references. Medtronic argued that the PTAB erred by construing sequential performance of the recited steps, specifically, stating that certain steps could be performed simultaneously.
Claim 1 of the '413 patent includes the following steps which, as used by the Federal Circuit, are simplified here for clarity.
Claim 1: A method of providing backup support for an interventional cardiology device (ICD) for use in the coronary vasculature, comprising:
1.a: inserting the standard guide catheter;
1.b: positioning the standard guide catheter;
1.c: inserting a coaxial guide catheter;
1.d: inserting a substantially rigid portion;
1.e: advancing the flexible tip portion; and
1.f: inserting and advancing the ICD.
The Federal Circuit agreed with the PTAB claim interpretation, asserting that although the steps of the method claim do not actually recite an order, the ordering of steps is interpreted in view of the claim language and the specification. For example, in regard to claim language, step 1.f requires "inserting the [ICD] into and through the continuous lumen of the standard guide catheter alongside of the substantially rigid portion and advancing the [ICD] through and beyond a lumen of the flexible tip portion". The Federal Circuit concluded that the antecedent basis of the substantially rigid portion and the flexible tip portion indicated that the step 1.f occurs after step 1.e. Also, the sequential order is determined based on the physical requirements of the substantially rigid portion as it is "operably connected" to the flexible tip portion, and therefore, step 1.d cannot occur prior to 1.c. In addition, the Federal Circuit acknowledged that the specification of the '413 patent highlights the advantages of performing the steps in sequential order.
Medtronic argued that the use of the phrase "alongside of" in step 1.f, can be interpreted that the ICD and coaxial guide catheter are inserted simultaneously, and referenced two cars pulling up to a stoplight "alongside of" each other. The Federal Circuit argued that although this is one use of the phrase "alongside of", it does not apply to claim 1 in the context of the claim language and specification. In addition, Medtronic agreed that other steps of the claim 1 would occur in sequential order, and therefore the Federal Circuit asserted that it would "be unnatural to read every part of the claimed method to require an ordered performance except for one half of one step".
Regarding the determination that the references could not be combined in the first IPR petition, the Federal Circuit asserted that the PTAB properly considered the combination of references Itou (US Patent No. 7,736,355) and Ressemann (US Patent No. 7,604,612), and that in light of the evidence provided by
As to the second IPR petition, Medtronic asserted that Kontos (US Patent No. 5,439,445) met the inserting and advancing the ICD step 1.f of claim 1. However, the PTAB concluded that Kontos did not render claim 1 obvious, because Kontos did not meet the requirement of inserting the ICD after advancing the flexible tip portion. Thus, in light of the sequential step interpretation as previously discussed, Kontos does not render claim 1 as obvious. The PTAB also concluded that Kontos would not be combined with Adams (US Patent App. Pub. No. 2004/0010280), as Adams undermines the teachings of Kontos. The Federal Circuit affirmed the finding that in light of the drawbacks of Medtronic's proposed combination, a skilled artisan would not combine Kontos and Adams.
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.
Tel: 703413 3000
Fax: 703413 2220
E-mail: caskey@oblon.com
URL: www.oblon.com
© Mondaq Ltd, 2024 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source
