UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER’S CONSOLIDATED RESPONSE ADDRESSING
`CONCEPTION AND REDUCTION TO PRACTICE
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER’S CONSOLIDATED RESPONSE ADDRESSING
`CONCEPTION AND REDUCTION TO PRACTICE
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`I.
`EVIDENCE SUBMITTED IN SUPPORT OF PRIOR INVENTION ........... 2
`II.
`III. BACKGROUND ............................................................................................. 3
`A. VSI ......................................................................................................... 3
`B.
`Conception of the Invention of the GuideLiner Patents ....................... 3
`C.
`Reduction to Practice............................................................................. 7
`D.
`Continued Work Towards Commercialization ................................... 18
`ITOU IS NOT PRIOR ART TO THE CLAIMED INVENTIONS .............. 19
`A.
`The VSI Inventors Reduced the Claimed Invention to Practice
`Prior to September 23, 2005 ................................................................ 21
`Reasonably Diligent Work on the Invention Continued Through
`the Filing of the Patent Application on May 3, 2006 .......................... 28
`CONCLUSION .............................................................................................. 29
`V.
`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 30
`CERTIFICATION OF SERVICE............................................................................ 31
`
`IV.
`
`B.
`
`
`
`
`
`
`
`
`
`
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Arctic Cat Inc. v. GEP Power Prods.,
`919 F.3d 1320 (Fed. Cir. 2019) ............................................................... 19, 20, 28
`Cooper v. Goldfarb,
`154 F.3d 1321 (Fed. Cir. 1998) ............................................................................ 24
`DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
`928 F.2d 1122 (Fed. Cir. 1991) ............................................................................ 25
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ..................................................................... 20, 21
`E.I. du Pont de Nemours & Co. v. Unifrax I LLC,
`921 F.3d 1060 (Fed. Cir. 2019) ............................................................................ 22
`In re Asahi/America Inc.,
`68 F.3d 442 (Fed. Cir 1995) ................................................................................. 21
`In re Dardick,
`496 F.2d 1234 (C.C.P.A. 1974) ............................................................................ 21
`In re Stryker,
`435 F.2d 1340 (C.C.P.A. 1971) ............................................................................ 23
`Loral Fairchild Corp. v. Matsushita Elec. Indus. Co.,
`266 F.3d 1358 (Fed. Cir. 2001) ............................................................... 22, 24, 27
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) ........................................................... 20, 21, 25, 27
`Perfect Surgical Techniques, Inc. v. Olympus America, Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) ............................................................................ 28
`Purdue Pharma L.P. v. Boehringer Ingelheim GmbH,
`237 F.3d 1359 (Fed. Cir. 2001) ............................................................................ 20
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ................................................................. 20, 21, 22
`
`iii
`
`
`
`Statutes
`
`Statutes
`35 U.S.C. §102(e) ............................................................................................... 1, 19
`35 U.S.C. §102(e) ............................................................................................... 1, 19
`
`
`iv
`
`iV
`
`
`
`I.
`
`INTRODUCTION
`This consolidated brief is submitted in response to the consolidated
`
`scheduling order authorizing the parties to file consolidated briefs specifically
`
`addressing the issues of conception and reduction to practice that are relevant to
`
`IPR2020-00126, -00128, -00129, -00132, -00134, -00135 and -00137. The patents
`
`at issue are collectively referred to as “the GuideLiner patents.”
`
`
`
`These IPRs all rely, in whole or in part, on U.S. Patent No. 7,736,355
`
`(“Itou”), which Medtronic asserts is prior art under 35 U.S.C. §102(e) based on an
`
`effective filing date of September 23, 2005. Itou is not prior art to the GuideLiner
`
`patents. The evidence shows that between January and August 2005, the inventors
`
`and others working on their behalf built and tested GuideLiner prototypes and
`
`confirmed they would work for their intended purpose. Corroborating the success
`
`of this testing, a decision was made in August 2005 to move forward with
`
`commercializing the GuideLiner. Thus, the fully corroborated facts demonstrate
`
`that the GuideLiner patents were actually reduced to practice prior to the effective
`
`filing date of the Itou reference. Moreover, although not necessary to pre-date
`
`Itou, diligent work on GuideLiner continued from September 2005 to the filing of
`
`its original priority application on May 3, 2006, thus providing an additional basis
`
`to conclude that Itou is not prior art.
`
`1
`
`
`
`II. EVIDENCE SUBMITTED IN SUPPORT OF PRIOR INVENTION
`
`
`
`Patent Owner submits the following evidence in support of its showing of
`
`prior invention over Itou:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`
`7.
`
`8.
`
`Declaration of Howard Root (inventor) (Ex. 2118)1;
`
`Declaration of Gregg Sutton (inventor) (Ex. 2119);
`
`Declaration of Steven Erb (VSI/Teleflex Technologist) (Ex. 2122);
`
`
`
`Declaration of Deborah Schmaltz (former VSI employee) (Ex. 2039);
`
`Declaration of Peter T. Keith (independent expert) (Ex. 2123);
`
`Declaration of Amanda O’Neil (TE Connectivity employee) (Ex.
`2121);
`
`Declaration of Mark Goemer (SPECTRAlytics employee) (Ex. 2120);
`
`Exhibits 2002-2038, 2040-41, 2089-2117, and 2127-2134.2
`
`
`
`
`
`
`1 Patent Owner hereby withdraws the Declaration of Howard Root submitted as
`
`Exhibit 2001 in connection with its Preliminary Response. Root’s declaration
`
`submitted in support of this brief (Exhibit 2118), includes new evidence discovered
`
`in the time since he submitted his prior declaration.
`
`2 Patent Owner hereby withdraws it prior request to seal Exhibit numbers 2002,
`
`2004-2011, 2013-2014, 2016, 2019-2035, and 2040. Each of these exhibits may be
`
`considered public documents.
`
`2
`
`
`
`III. BACKGROUND
`
`A. VSI
`
`
`
`The patented GuideLiner rapid exchange guide extension catheter was
`
`developed at Vascular Solutions, Inc. (“VSI”). VSI developed, manufactured, and
`
`sold specialty products for interventional cardiology procedures and other medical
`
`procedures. (Ex. 2118, ¶4.)
`
`Post-conception, VSI’s development of new products typically occurred in
`
`at least two phases. First, VSI would build and test prototypes to prove the
`
`concept. When the concept was proven, VSI would move to the
`
`commercialization phase, where it would refine the product so it could be cost-
`
`effectively manufactured in accordance with exacting specifications and rigid
`
`safety protocols required by the FDA. (Exs. 2118, ¶54; 2119, ¶44; 2039, ¶¶6-7,
`
`11.) The dividing line between the phases was a “Product Requirements”
`
`document that initiated tracking in VSI’s Quality system. (Id.) VSI would not
`
`begin this Quality process unless and until it was confident that a product would
`
`work for its intended purpose. (Id.)
`
`B. Conception of the Invention of the GuideLiner Patents
`
`
`
`In the fall of 2004, Root attended the annual Transcatheter Cardiovascular
`
`Therapeutics conference (“TCT”) in Washington, D.C. (Ex. 2118, ¶5.) At that
`
`time, he was aware that physicians conducting complex interventional coronary
`
`3
`
`
`
`procedures often had trouble with guide catheters backing out of the coronary
`
`ostium during delivery of a stent or angioplasty balloon. (Id.) Around the time of
`
`the conference, he conceived of the idea for a rapid exchange device that that
`
`would provide improved back-up support and offer far more conveniences than
`
`other options available at the time. (Id. at ¶¶5-6; see also Ex. 2119, ¶9.) After
`
`TCT, but before 2005, Root and the other named inventors met to discuss how to
`
`make such a device. (Ex. 2118, ¶6.)
`
`
`
`At a high level, the inventors conceived of a rapid exchange guide extension
`
`catheter to be used within a one French size larger guide catheter. (Exs. 2118, ¶¶7,
`
`9, 12; 2119, ¶12; 2002; 2004.) The guide extension catheter included a
`
`substantially rigid proximal portion comprising a “rail” structure and a tubular
`
`portion with a lumen distal of the proximal portion, which together were longer
`
`than the overall length of a standard guide catheter. (Exs. 2118, ¶¶7, 9; 2119,
`
`¶¶11-13; 2002.) The distal tube portion was reinforced with a braid or coil, and
`
`could have a highly flexible atraumatic “bumper tip.” (Exs. 2118, ¶¶7, 9; 2119,
`
`¶11; 2002.)
`
`In use, a standard guide catheter would first be inserted into the vasculature
`
`until the distal end was adjacent the ostium of a cardiac artery within the heart.
`
`(Exs. 2118, ¶7, 10; 2119, ¶13; 2002.) The guide extension catheter would then be
`
`inserted through the guide catheter until the tubular portion’s distal end extended
`
`4
`
`
`
`past the distal end of the guide catheter and into the cardiac artery. (Id.) An
`
`interventional cardiology device, such as a stent or balloon catheter, would then be
`
`inserted through the guide catheter (running alongside the rail of the guide
`
`extension catheter), into and through the proximal end of the tubular portion of the
`
`guide extension catheter, out the distal end of the tubular portion, and into the
`
`cardiac artery. (Id.)
`
`
`
`Conception of the invention is reflected, inter alia, in inventor Gregg
`
`Sutton’s notebook, dated January 5, 2005, for the “Guide-Liner Device.” (Exs.
`
`2119, ¶¶7-9; 2118, ¶¶8-10; 2002.) This notebook lays out the idea for the
`
`invention and includes illustrations that are nearly identical to several figures in the
`
`GuideLiner patents, including Figure 2:
`
`
`
`5
`
`
`
`(Exs. 2002; 1001, Fig. 2.) A February 2005 drawing by Root is very similar to
`
`Figure 1 of the patents:
`
`
`
`
`
`
`
`(Exs. 2004; 1001, Fig. 1.) This February 2005 document also reflects conception
`
`of the “side opening” at the proximal end of the tubular portion that facilitates
`
`entry of a stent or balloon catheter into the tubular portion. (Ex. 2118, ¶¶12-14.)
`
`A February 4, 2005 memo further reflects the design features of the contemplated
`
`GuideLiner device. (Exs. 2118, ¶11; 2127.)
`
`6
`
`
`
`C. Reduction to Practice
`
`VSI immediately began prototyping and testing the GuideLiner concept to
`
`confirm that it would work. (Exs. 2118, ¶¶15-18; 2119, ¶¶16, 18, 20; 2122, ¶¶5-
`
`14.) In January 2005, a VSI technician ordered hypotubes and used an in-house
`
`milling machine to cut down the proximal portion of what would become
`
`GuideLiner prototypes. (Exs. 2122, ¶¶5-9; 2118, ¶¶16, 23-24; 2119, ¶20; 2110.)
`
`These cut-down proximal portions were bonded to distal polymer tubular portions,
`
`first using an adhesive, and for later prototypes, a heat-shrink tubing and a reflow
`
`process. (Exs. 2122, ¶10; 2118, ¶¶16, 23-24; 2119, ¶35.) Significant testing was
`
`performed on these early prototypes. (Exs. 2118, ¶¶16-18; 2119, ¶¶16-17, 23, 41;
`
`2122, ¶¶5, 11-13; 2003.) From the beginning, the inventors and others at VSI were
`
`confident the device would work for its intended purpose. (Exs. 2118, ¶¶15-18;
`
`2119, ¶¶6, 16, 18, 23; 2122, ¶13.)
`
`VSI soon began to make more sophisticated GuideLiner prototypes for
`
`additional testing. These involved a distal tubular portion made of extruded
`
`polymer around a PTFE liner with an embedded metal braid, and a proximal
`
`portion made from a metal hypotube that was machined to remove varying
`
`amounts of the side wall of the tube. (Exs. 2118, ¶¶23-35, 39-51, 84; 2119, ¶¶21-
`
`36; 2122, ¶¶7-10; 2120, ¶¶6-12; 2121, ¶¶ 4-6; 2002; 2006-2011; 2013; 2020-2022;
`
`2026-2027; 2032-2035; 2089; 2090-2091; 2092; 2094-2095; 2097l 2110; 2111-
`
`7
`
`
`
`2115.) The proximal portion served as a push member for the device, as well as
`
`the opening into the distal tubular portion. (Exs. 2118, ¶¶18, 34, 41, 49-50, 84;
`
`2119, ¶¶11, 24, 32.) VSI outsourced these and other parts and did the final
`
`assembly and testing in-house. (Ex. 2118, ¶¶15-58; 2119, ¶¶ 36-37; 2122, ¶12.)
`
`VSI built at least two different sets of these more sophisticated prototypes
`
`prior to August 2005. For the first set, VSI ordered 20 distal tubular portions from
`
`Medical Engineering & Design, Inc. (“MED”) on February 17, 2005. (Ex. 2118,
`
`¶¶25, 31; 2119, ¶¶32-33; 2089 at 6; 2011.) Below is a drawing of the design for
`
`the distal tubular portion, dated February 10, 2005, that VSI provided to MED for
`
`this order:
`
`
`
`
`
`8
`
`
`
`(Exs. 2089 at 8; 2121, ¶5.) The distal section was made up of three different Pebax
`
`polymers having different stiffnesses formed around a PTFE liner:
`
`
`
`
`
`(Id.; see also Ex. 2118, ¶25.) A reinforcing braid was embedded along the entire
`
`length of the polymer, except the most proximal and distal portions:
`
`(Id.) The most distal, unreinforced portion provided a soft tip and the proximal
`
`end was formed for connecting to the hypotube:
`
`9
`
`
`
`
`
`(Id.) The outer diameter of the tube was 0.066 inches, which is consistent with its
`
`intended use inside a 6 French guide catheter having an ID of at least 0.070 inches,
`
`and the inner diameter was 0.057 inches. (Ex. 2089 at 7.) MED delivered these
`
`distal tubular sections to VSI on April 5, 2005. (Id. at 1.)
`
`
`
`VSI also ordered hypotubes for the proximal portions of these prototypes
`
`and outsourced them to be laser cut. On March 21, 2005, VSI placed an order with
`
`SPECTRAlytics to laser cut 20 hypotubes for the prototypes. (Exs. 2118, ¶32-33;
`
`Ex. 2119, ¶30; 2013 at 3; 2095 at 3.) SPECTRAlytics completed that order on
`
`April 4 and 5, 2005. (Ex. 2095 at 1-2.) The hypotubes were cut to have a full
`
`circumference at their distal end, multiple angled transition regions bookending
`
`non-inclined regions, and a proximal rail structure. (Exs. 2118, ¶34; 2113.) Below
`
`is a drawing, dated February 4, 2005, that VSI provided to SPECTRAlytics for the
`
`order:
`
`10
`
`
`
`
`
`(Id.; Ex. 2120, ¶9.)
`
` VSI then attached the distal end of the hypotubes cut down by
`
`SPECTRAlytics to the proximal end of the tubular sections from MED to form
`
`complete prototypes for analysis and testing. (Exs. 2118, ¶35; 2119, ¶35; 2122,
`
`¶12.)
`
`VSI’s testing of the prototypes included use of models that emulated the
`
`coronary vasculature of a human heart. (Ex. 2118, ¶¶17-18, 38, 47; see also Exs.
`
`2119, ¶41; 2122, ¶¶6, 11-12.) Attached is a picture showing a model that was used
`
`for this testing:
`
`11
`
`
`
`
`
`(Exs. 2018; 2118, ¶¶17, 38.) Such models were commonly used by VSI and other
`
`medical device companies to test interventional cardiology devices and to confirm
`
`they would serve their intended purpose inside a human heart. (Exs. 2118, ¶17;
`
`2123, ¶¶20-24.) VSI’s testing included inserting a standard guide catheter into the
`
`coronary model, advancing the GuideLiner prototype into the guide catheter until
`
`the distal end of the prototype extended beyond the distal end of the standard guide
`
`catheter, then delivering a stent or balloon catheter into the guide catheter, into and
`
`through the tubular portion of the prototype, and out the distal end of the prototype.
`
`(Exs. 2118, ¶¶17-18, 38, 47; see also Exs. 2119, ¶41; 2122, ¶¶11-12.) Testing is
`
`further corroborated by records showing that VSI purchased Medtronic guide
`
`catheters on April 6, 2005 to use in testing the prototypes (Exs. 2118, ¶¶36, 47;
`
`2119, ¶37; 2016), as well as the July 2005 presentation showing an example of a
`
`12
`
`
`
`guide catheter and a balloon catheter used in the testing. (Ex. 2118, ¶¶17, 38, 47;
`
`2129.)3
`
`
`
`Vendor records also corroborate that a second set of prototypes was built
`
`and tested in June/July 2005. Specifically, VSI received another 21 “Guide Liner
`
`Distal Sections” from MED on June 16, 2005. (Exs. 2118, ¶¶44-45, 51; 2119, ¶34;
`
`2021; 2092 at 1-3), and ordered laser-cutting by SPECTRAlytics of another 20
`
`hypotubes on June 23, 2005. (Exs. 2118, ¶43; 2019, ¶31; 2111; 2114; 2020.)
`
`SPECTRAlytics cut this set of hypotubes with a revised design, shown in the June
`
`21, 2005 drawing below, and received by SPECTRAlytics on June 28, 2005:
`
`
`3 For a time, VSI pursued development of a non-patented, over-the-wire (“OTW”)
`
`guide extension catheter, in parallel with the patented GuideLiner rapid exchange.
`
`(Exs. 2118, ¶19; 2119, ¶15.) Because it was based on existing technology, and
`
`would have fewer regulatory hurdles, the company believed it could bring the
`
`OTW version to market quicker. (Exs. 2118, ¶19; 2017). Accordingly, the
`
`GuideLiner prototype shown in the July presentation is the OTW version of the
`
`product. (Ex. 2118, ¶38.) VSI ultimately abandoned the OTW version and only
`
`commercialized the GuideLiner rapid exchange. (Id. at ¶19.)
`
`13
`
`
`
`
`
`(Exs. 2118, ¶41; 2114; Ex. 2120, ¶11.) These drawings correspond almost
`
`identically to Figures 12-16 of the GuideLiner patents:
`
`
`
`
`
`14
`
`
`
`
`
`(Ex. 1001.)
`
`As with the first set, VSI did the final assembly of the prototypes in-house
`
`and promptly tested them using the benchtop models discussed above. (Exs. 2118,
`
`¶¶46-47; 2119, ¶¶22, 41, 43, 47; 2130 at 3; 2122, ¶¶11-12.) This testing confirmed
`
`that the prototypes also could successfully deliver stents and balloon catheters
`
`along the rail segment, into the side opening and distal tubular portion, out the
`
`distal end of the distal tubular portion, and into challenging coronary anatomy.
`
`(Exs. 2118, ¶¶17-18, 38, 47; 2119, ¶41; 2122, ¶¶11-12.)
`
`
`
`The following CAD drawing is dated August 1, 2005 and shows a complete
`
`rapid exchange GuideLiner:
`
`15
`
`
`
`
`
`(Ex. 2022; see also Exs. 2118, ¶¶49-51; 2119, ¶39.) These drawings are nearly
`
`identical to Figures 3 and 4 of the GuideLiner patents:
`
`(Ex. 1001.) The label on the drawing, “Preliminary Design Assumption Rev.
`
`X03,” shows that VSI had made significant advances in its design and prototypes
`
`16
`
`
`
`
`
`
`
`and was getting ready to begin the formal Quality process for bringing the rapid
`
`exchange GuideLiner to market. (Exs. 2118, ¶49; 2119, ¶39.)
`
`
`
`An August 24, 2005 “Product Requirements” document discusses both the
`
`rapid exchange and OTW versions of the GuideLiner. (Exs. 2118, ¶54; 2119, ¶44;
`
`2039, ¶6; 2024.) Product Requirements documents signaled VSI’s transition to the
`
`formal Quality process for bringing medical devices to market. (Id.) According to
`
`VSI’s standard practice, such documents would not be created until prototypes had
`
`been made and tested to show that they would work for their intended purpose.
`
`(Id.) An August 26, 2005 Clinical Technical Report further confirms that
`
`GuideLiner worked as intended and was ready to move toward commercialization.
`
`(Exs. 2118, ¶¶55-57; 2119, ¶¶45-46; 2039, ¶¶9-10; 2025; see also Ex. 2040.) Such
`
`clinical literature reviews were conducted as part of the process for the FDA’s
`
`510(k) regulatory approval. (Id.) According to VSI’s standard practice, a
`
`regulatory strategy would not have been decided upon, and clinical technical
`
`reviews would not have been pursued, unless prototypes had been made and
`
`successfully tested to show that they worked for their intended purpose. (Id.)
`
`
`
`
`
`
`
`
`
`
`
`17
`
`
`
`D. Continued Work Towards Commercialization
`
`
`
`In August 2005, VSI began working with its outside patent counsel
`
`(Patterson) on the application for the GuideLiner patents. On August 11, 2005,
`
`Patterson opened a prior art search file for GuideLiner. (Exs. 2118, ¶¶52-53; 2023;
`
`2096.) Patterson reported the results of its prior art search on September 14, 2005
`
`and, at Root’s direction, opened a new patent application file for GuideLiner on
`
`October 5, 2005. (Exs. 2118, ¶¶61-62; 2023; 2098.) Although not all of the
`
`records relating to the patent application were maintained, existing documents
`
`show ongoing work on the patent application. VSI provided Patterson with,
`
`among other things, the August 1, 2005 CAD drawing discussed above. (Exs.
`
`2118, ¶¶49-50; 2119, ¶39; 2022.) Billing records show that substantial work was
`
`done by Patterson on the draft patent application in January and March 2006.
`
`(Exs. 2118, ¶¶66, 68; 2101; 2013; 2117.) Inventor Sutton sent Patterson additional
`
`sketches and drawings for the patent application on January 23, 2006 and March
`
`21, 2006. (Exs. 2119, ¶¶40, 42; 2118, ¶¶42, 67; 2019; 2102.) The inventors and
`
`Patterson also exchanged emails about the patent application on March 15, 2006
`
`and April 12, 2006. (Ex. 2098.)
`
`While Patterson prepared the patent applications, VSI refined details of the
`
`rapid exchange GuideLiner for commercialization. Root and Sutton reported to the
`
`VSI Board of Directors in October 2005 that VSI’s physician advisors had
`
`18
`
`
`
`favorably evaluated the rapid exchange GuideLiner and that a 510(k) regulatory
`
`submission was planned for the first quarter of 2006. (Exs. 2118, ¶62; 2119, ¶47;
`
`2133.) That regulatory submission was postponed while the company continued to
`
`optimize the device for commercialization. Although it knew the GuideLiner rapid
`
`exchange would work for its intended purpose, the company needed time to
`
`identify the materials and processing that would make the device both cost
`
`effective and efficient to manufacture. (Exs. 2118, ¶¶65, 90-91; 2119, ¶¶48-49;
`
`2122, ¶¶13-14; see also 2123, ¶¶25-27.) As shown by contemporaneous
`
`documents, that process was ongoing, but required more time and resources than
`
`the company originally anticipated. (Exs. 2118, ¶¶59-60, 62-65, 69-75, 87-91;
`
`2119, ¶¶48-52; 2099; 2100; 2104; 2105; 2106; 2107; 2108; see also 2039, ¶12; Ex.
`
`2123, ¶¶25-27.)
`
`IV.
`
`ITOU IS NOT PRIOR ART TO THE CLAIMED INVENTIONS
`Petitioner asserts that Itou is prior art under 35 U.S.C. §102(e) based on its
`
`September 23, 2005 filing date. To qualify as prior art under §102(e), a reference
`
`must have been filed in the United States before the applicant’s invention. Arctic
`
`Cat Inc. v. GEP Power Prods., 919 F.3d 1320, 1330 (Fed. Cir. 2019). As such,
`
`Itou is not prior art if the VSI inventors either (a) reduced the claimed invention to
`
`practice prior to September 23, 2005, or (b) conceived of the claimed invention
`
`prior to September 23, 2005, and exercised reasonable diligence between
`
`19
`
`
`
`September 23, 2005 and a later actual or constructive reduction to practice. See
`
`e.g., Arctic Cat, 919 F.3d at 1331; Purdue Pharma L.P. v. Boehringer Ingelheim
`
`GmbH, 237 F.3d 1359, 1365 (Fed. Cir. 2001); Mahurkar v. C.R. Bard, Inc., 79
`
`F.3d 1572, 1579 (Fed. Cir. 1996).4
`
`The Petitioner bears the burden of proving that the references upon which it
`
`relies constitute prior art. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800
`
`F.3d 1375, 1380 (Fed. Cir. 2015). That burden is initially met simply by showing
`
`that the effective filing date of the reference is prior to that of the challenged
`
`patent(s). Once the Patent Owner comes forward with evidence of an earlier
`
`invention date, however, the burden then falls to Petitioner to prove that invention
`
`did not occur prior to the filing date of the alleged prior art reference. Id. The
`
`
`4 Some cases also recite conception as an element of proof in the case of actual
`
`reduction to practice prior to the critical date. See Mahurkar, 79 F.3d 1572, 1578
`
`(Fed. Cir. 1996). Given the practical reality that one cannot reduce something to
`
`practice that has not been conceived, most actual reduction to practice cases do not
`
`separately analyze conception. See, e.g., Scott v. Finney, 34 F.3d 1058, 1061 (Fed.
`
`Cir. 1994). Regardless, the evidence of conception in this case is clear and
`
`undisputable. (See Exs. 2118, ¶¶5-14; 2119, ¶¶7-15; 2002-2004.)
`
`20
`
`
`
`ultimate burden of proof remains on the Petitioner and never shifts to the Patent
`
`Owner. Id. at 1378.
`
`A.
`
`The VSI Inventors Reduced the Claimed Invention to Practice
`Prior to September 23, 2005
`
`
`Reduction to practice occurs when the inventor or those working on the
`
`
`
`inventor’s behalf: (a) constructs an embodiment or performs a process that meets
`
`the claimed invention; and (b) demonstrates that the invention is “suitable for its
`
`intended purpose.” Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir. 1994) (citations
`
`omitted). Reduction to practice “does not require ‘that the invention, when tested,
`
`be in a commercially satisfactory stage of development.’” Id. (quoting In re
`
`Dardick, 496 F.2d 1234, 1238 (C.C.P.A. 1974)). Moreover, the type and amount
`
`of any testing needed to demonstrate that the invention was suitable depends on the
`
`nature of the invention. Id. at 1061-62 (discussing cases). Many cases have found
`
`inventions to be reduced to practice based on little, or even no testing of the
`
`invention when the principles of operation of the invention are not complex. See
`
`In re Asahi/America Inc., 68 F.3d 442, 446-47 (Fed. Cir 1995) (no testing required
`
`for pipe coupling system invention); Mahurkar, 79 F.3d at 1578 (flow and pressure
`
`drop testing in inventor’s kitchen held sufficient for dual lumen catheter
`
`invention); Scott, 34 F.3d at 1063 (inflation/deflation testing sufficient for penile
`
`implant invention). In cases where testing is required, the testing need not show
`
`21
`
`
`
`utility beyond a possibility of failure, but only utility beyond a probability of
`
`failure. Scott, 34 F.3d at 1062.
`
`
`
`Like other issues associated with prior invention, testimonial evidence from
`
`an inventor regarding reduction to practice must be corroborated by independent
`
`evidence. Loral Fairchild Corp. v. Matsushita Elec. Indus. Co., 266 F.3d 1358,
`
`1363-65 (Fed. Cir. 2001). The sufficiency of such corroborating evidence is
`
`evaluated under the “rule of reason,” which considers all of the pertinent evidence
`
`to determine whether the inventor(s)’ testimony regarding reduction to practice is
`
`credible. Id.; see also E.I. du Pont de Nemours & Co. v. Unifrax I LLC, 921 F.3d
`
`1060, 1077 (Fed. Cir. 2019).
`
`Submitted herewith are Declarations testifying that, prior to September
`
`2005, prototypes of the claimed invention were made and tested to confirm that
`
`they would work for their intended purpose. (Ex. 2118, ¶¶15-58; Ex. 2119, ¶¶6,
`
`16-46; 2122, ¶¶5-13; 2039, ¶¶6-10.) Root’s declaration also includes detailed
`
`charts that map the GuideLiner patent claims to the prototypes and establish that
`
`the prototypes contained all limitations of at least the claims for which Petitioner is
`
`relying on Itou.5 (Ex. 2118, ¶¶78-82 and Appx. A-E; Ex. 2123, ¶28.)
`
`
`5 In those instances where Petitioner is asserting obviousness based on Itou, the
`
`evidence need only show prior invention of those aspects of the claims that
`
`22
`
`
`
`Testimony from Root and Sutton about the existence and testing of
`
`prototypes is well corroborated by non-inventor testimony, as well as documentary
`
`evidence, including engineering drawings, vendor invoices for components,
`
`documents referring to prototypes having been built and evaluated, and the August
`
`24, 2005 “Product Requirements” document. See supra pp. 7-17. As explained
`
`above, the invoices and the drawings (many of which came out of the files of, and
`
`are authenticated by, the third-party vendors) show that the components for at least
`
`two sets of prototypes were delivered to VSI—the first set in April 2005, and the
`
`second set in June/July 2005. Id. The July 2005 presentation shows an example of
`
`a benchtop coronary model that was used for testing, as well as an example of a
`
`standard guide catheter and balloon catheter that were used as part of the testing.
`
`(Exs. 2018; 2118, ¶17.) Non-inventor testimony corroborates VSI’s testing of
`
`GuideLiner prototypes. (Exs. 2039, ¶¶5-7, 9-12; 2122, ¶¶11-13.) And as further
`
`corroborated by non-inventor testimony, the August 24, 2005 “Product
`
`Requirements” document marked the transition to the formal Quality process of
`
`
`Petitioner contends are present in Itou in order to remove Itou as prior art. See In
`
`re Stryker, 435 F.2d 1340 (C.C.P.A. 1971) (holding that if an obviousness rejection
`
`is well-founded, then prior invention of what is shown in primary reference is
`
`sufficient to overcome the rejection).
`
`23
`
`
`
`bringing a commercial product to market, and was only drafted after a product had
`
`been built, tested, and determined to work for its intended purpose. (Ex. 2039,
`
`¶¶6-7.)
`
`Under the rule of reason, proof of reduction to practice “does not require
`
`corroboration for every factual issue contested by the parties.” Cooper v.
`
`Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998). Rather, the corroborating
`
`evidence must merely be sufficient to render the inventor’s testimony credible. Id.
`
`In Loral Fairchild, the Federal Circuit criticized the district court for requiring
`
`documentary evidence of test results and held that evidence showing that a
`
`component needed to practice the invention was delivered prior to the critical date
`
`was alone sufficient to corroborate the inventor testimony’s on reduction to
`
`practice. Loral Fairchild, 266 F.3d at 1364-65. In Cooper, the Federal Circuit
`
`held that the inventor's testimony was sufficiently corroborated by testimony of his
`
`co-workers that he had told them of his reduction to practice, and that they had
`
`seen him obtain materials of the type necessary to practice the invention. Cooper
`
`at 1330. Here, the evidence supporting the inventors’ testimony is much more
`
`robust than that of either Loral Fairchild or Cooper.
`
`As the corroborated evidence shows, testing in a benchtop model was
`
`sufficient to establish reduction to practice of the GuideLiner invention. Even
`
`when testing is necessary, there is no need to test the invention in its actual
`
`24
`
`
`
`working environment as long as the test environment is sufficiently similar to
`
`demonstrate workability. DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
`
`928 F.2d 1122, 1125 (Fed. Cir. 1991). Catheter inventions are routinely
`
`determined to work using benchtop models, and without human testing. (Ex. 2123,
`
`¶¶20-24; see also Ex. 1010 (using tests performed in a desk-model to show that a
`
`mother-and-child catheter provided increased back-up support).) Indeed, catheters
`
`need not be tested in humans to obtain FDA approval. (Ex. 2123, ¶24.) In
`
`Mahurkar, the Federal Circuit held as a matter of law that the invention was
`
`reduced to practice based on evidence that, prior to the critical date, the inventor
`
`conducted flow and pressure drop tests on his catheter invention in his kitchen.
`
`Mahurkar, 79 F.3d at 1578. Here, the benchtop model emulated cardiac anatomy
`
`and was sufficient to show that the prototype GuideLiners could serve their
`
`intended purpose of being placed in a standard guide catheter and deliver
`
`interventional cardiology devices alongside the rail segment, into the side opening
`
`and distal tubular portion, and then out the distal end of the distal tubular portion
`
`and into challenging coronary anatomy. (Exs. 2118, ¶¶17-18, 38, 47; 2119, ¶41;
`
`2123, ¶¶20-24.)
`
`This is particularly true in view of testimony given by Petitioner’s expert,
`
`Dr. Brecker regarding the Itou reference. Itou is directed to a suction catheter and
`
`thus is not designed to facilitate the delivery of stents or other interventional
`
`25
`
`
`
`cardiology devices into cardiac vasculature. (Ex. 2123, ¶15.) Nonetheless, Dr.
`
`Brecker enthusiastically testified that not only would Itou inherently perform the
`
`function of facilitating the delivery of stents or other interventional cardiology
`
`devices into the cardiac vasculature, but that a POSITA would know that Itou’s
`
`suction catheter would work for this purpose simply by looking at Itou’s drawings
`
`and without performing any testing whatsoever. (Ex. 2116, 104:13-109:9, 110:7-
`
`113:24.) This testimony by Dr. Brecker esta
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
