UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`
`____________
`
`Case IPR2014-00110
`Patent 6,482,228
`____________
`
`Attorney Docket No. 058888-0000014
`
`___________
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`
`____________
`
`Case IPR2014-00110
`Patent 6,482,228
`____________
`
`Attorney Docket No. 058888-0000014
`
`___________
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`C.
`
`NORRED CANNOT REMOVE DIMATTEO AS PRIOR ART ................... 1
`A.
`Proper Construction of the “Means for Mounting and Moving” .......... 1
`B.
`Norred Cannot Establish Conception Prior to the Effective Date of
`DiMatteo as a Reference (October 21, 1999)........................................ 4
`Norred Fails to Prove He Was Diligent in Reducing the Claimed
`Invention to Practice During the Critical Period ................................... 7
`DIMATTEO ANTICIPATES CLAIMS 16-19 ............................................. 12
`II.
`III. WOLFE ANTICIPATES CLAIMS 16-18 .................................................... 13
`IV. CONCLUSION .............................................................................................. 15
`
`
`
`
`EXHIBIT LIST
`
`Exhibit Description
`U.S. Patent 5,469,868 to Reger
`U.S. Patent 6,245,101 to Drasler et al.
`Transcript of October 7, 2014 Deposition of Timothy Titus Catch-
`ings, M.D.
`Transcript of October 8, 2014 Deposition of Troy R. Norred, M.D.
`Transcript of October 9, 2014 Deposition of James J. Kernell
`Corrected Petition (Paper 4) in IPR2014-00111
`Translation of German Patent App. No. DE 195-46-692 to Figulla et
`al. - Application as Filed (with a certification from Abraham I.
`Holczer attesting to the accuracy of the translation) (This is Exhibit
`1006 in IPR2014-00111) (Patent Owner Exhibit 2124 is the file his-
`tory for this patent without any translation)
`German Patent App. No. DE 198-57-887 A1 to Fraunhofer Corpora-
`tion (This is Exhibit 1007 in IPR2014-00111)
`Translation of German Patent App. No. DE 198-57-887 A1 to
`Fraunhofer Corporation (with a certification from Abraham I.
`Holczer attesting to the accuracy of the translation) (This is Exhibit
`1008 in IPR2014-00111) (This is also Patent Owner Exhibit 2126)
`Declaration of Felix Harbsmeier with attached exhibits (1-5). (This
`is Exhibit 1013 in IPR2014-00111)
`Decision Instituting Inter Partes Review in IPR2014-00111 (Paper
`10)
`Expert Declaration of Alexander J. Hill, PhD
`
`“Anatomy of the aortic root: implications for valve-sparing sur-
`gery”, by Efstratios I. Charitos, Hans-Hinrich Sievers, Department
`of Cardiac and Thoracic Vascular Surgery, University of Lübeck,
`Lübeck, Germany, published in the Annals of Cardiothoracic Sur-
`gery, Vol. 2, No 1., pages 53-56 (January 2013)
`
`
`
`Exhibit No.
`1007
`1008
`1009
`
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`ABB v. Roy-G-Biv Corp.,
`IPR2013-00062, Paper 84 (April 11, 2014) ......................................................... 9
`
`Beckson Marine, Inc. v. NFM, Inc.,
`144 Fed. Appx. 862 (Fed. Cir. 2005) .................................................................... 4
`
`Bey v. Kollonitsch,
`806 F.2d 1024 (Fed. Cir. 1986) .......................................................................... 10
`
`Fidelity Nat'l Info. Servs., Inc. v. DataTreasury Corp.,
`IPR2014-00489, Paper 9 (August 13, 2014) ................................................ 13, 15
`
`Garmin v. Cuozzo,
`IPR2012-00001, Paper 59 (Nov. 13, 2013) .......................................................... 9
`
`Gould v. Schawlow,
`363 F.2d 908 (C.C.P.A. 1966) .............................................................................. 8
`
`In re Donaldson Co., Inc.,
`16 F.3d 1189 (Fed. Cir. 1994) .............................................................................. 1
`
`In re Enhanced Sec. Research, LLC,
`739 F.3d 1347 (Fed. Cir. 2014) .......................................................................... 10
`
`Iron Dome LLC v. E-Watch, Inc.,
`IPR2014-00439, Paper 16 (August 4, 2014) .............................................. 8, 9, 10
`
`Kondo v. Martel,
`223 USPQ 528 (Bd. Pat. Int'f 1984) ................................................................... 12
`
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) .............................................................................. 7
`
`Rines v. Morgan,
`250 F.2d 365 (C.C.P.A. 1957) ............................................................................ 10
`
`Slip Track Sys., Inc. v. Metal–Lite, Inc.,
`304 F.3d 1256 (Fed. Cir. 2002) ........................................................................ 4, 5
`
`iii
`
`
`
`Rules and Regulations
`
`Code of Federal Regulations
`Title 37, section 42.22(a)(2) ............................................................................... 13
`Title 37, section 42.6(a)(3) ................................................................................. 13
`
`
`
`
`
`
`
`
`iv
`
`
`
`Petitioner respectfully submits this Reply to Norred’s Response (Paper 15)
`
`to the Petition (Paper 4).
`
`I.
`
`NORRED CANNOT REMOVE DIMATTEO AS PRIOR ART
`
`In his Response, Norred argues that DiMatteo (Ex. 1003) is not prior art be-
`
`cause he conceived of the invention of claims 16-19 of the ‘228 patent (Ex. 1001)
`
`by December 21, 1998, and exercised reasonable diligence from DiMatteo’s prior
`
`art date (October 21, 1999) to the date he constructively reduced his inventions to
`
`practice by filing the ‘228 application (November 14, 2000). See Response at 6-30.
`
`However, for the reasons set out below, Norred has not and cannot establish either
`
`conception that predates DiMatteo, nor the necessary diligence.
`
`A.
`Proper Construction of the “Means for Mounting and Moving”
`Claim 16 recites a “means for mounting said first open end of said mem-
`
`brane about said ring aperture with said second open end displaced therefrom, said
`
`means moving said membrane second end between a first open position to allow a
`
`blood flow therethrough and a second closed position to preclude a blood flow
`
`therethrough.” (Emphasis added). This “means plus function” limitation is to be
`
`interpreted under §112, ¶6 (Decision, Paper 10 at 7) to cover the structures de-
`
`scribed in the specification for performing the claimed functions and equivalents.
`
`In re Donaldson Co., Inc., 16 F.3d 1189, 1193 (Fed. Cir. 1994) (en banc).
`
`In the conical valve embodiment of Figs. 10-13, the “means for mounting
`
`
`
`and moving” comprise fingers 68 having a first end hingedly secured to the ring 72
`
`and a free second spaced therefrom. Ex. 1001, 4:54-5:14. “The fingers 68 … are
`
`hingedly secured together by ring 72 extending through the base 74 of each finger
`
`68 and interconnected by … fabric 75 membrane secured to the inside surfaces 69
`
`of the fingers.” Id., 4:56-61. “The fingers 68 extend generally radially inwardly
`
`and away from the base 70.” Id., 4:61-63. “In the closed position (FIGS. 10-11),
`
`the tops 76 of the fingers contact each adjacent fingertip 76 to prevent regurgita-
`
`tion.” Id., 4:65-67. During systole “[f]ingers 68 pivot on ring 72 and tips 76 sepa-
`
`rate to allow blood to flow through the center of valve 66. …” Id., 5:9-14.
`
`In the trihedral valve embodiment of Figs. 14-17, the “means for mounting
`
`and moving” comprise arms 84 having a first end hingedly attached to the ring 86
`
`and a free second spaced therefrom. Ex. 1001, 5:33-47. The “[a]rms 84 are
`
`hingedly attached to ring 86 of base 88 and extend upwardly and radially inwardly
`
`from base 88 to generally form a trihedron or cone.” Id., 5:35-39. “Each rod 84 has
`
`a crescent-shaped pad 90 at its free end.” Id., 5:39-40. “A cone-shaped membrane
`
`92 … is secured to each arm 84 and base 88.” Id., 5:40-42. “During diastole, back
`
`flow of blood from the aorta to the left ventricle causes valve 82 to close prevent-
`
`ing regurgitation (FIGS. 14-15).” Id., 5:43-45. “During systole, blood is ejected
`
`from the left ventricle to force valve 82 open and allow blood to flow into the as-
`
`
`
`2
`
`
`
`cending aorta through the center of valve 82.” Id., 5:45-47.1
`
`The structure of the “means for mounting and moving” should therefore be
`
`construed as “fingers or arms hingedly attached or hingedly secured to the ring
`
`member and a free end spaced therefrom” and equivalents. That is consistent
`
`with claim 17 which states the element includes “at least one arm having a first end
`
`hingedly secured to said ring member and a free second spaced therefrom.”
`
`In its Decision to Institute Trial, the Board adopted, as “reasonable at this
`
`stage of the proceeding,” a construction of the “means for mounting and moving”
`
`in terms of the membrane being “hingedly secured” or “hingedly attached” about
`
`the ring aperture. Paper 10 at 10. Petitioner submits that such a construction is in-
`
`complete because while it expresses a function (“hingedly secured” or “hingedly
`
`1 The umbrella valve of Figs. 6-9 is not relevant because blood flows around the
`
`umbrella when it is in a folded position; there is no “ring including an aperture
`
`for blood flow therethrough” as required by claim 16. See Ex. 1001, Fig. 6, 4:5-
`
`52. The cadaver/porcine valve of Figs. 18-19 is not relevant because the tissue
`
`(“membrane” per Norred) has leaflets that open/close like the native human
`
`valve being replaced. There are no structures (“means”) added to mount the tis-
`
`sue with a “first open end … and a second open end displaced therefrom,” and to
`
`move “said [tissue] second end between a first open position … and a second
`
`closed position,” all as required by claim 16. See id., Figs. 18-19, 5:63-6:8.
`
`
`
`3
`
`
`
`attached”), it lacks any structure for performing the function.
`
`A case in point is Beckson Marine, Inc. v. NFM, Inc., 144 Fed. Appx. 862
`
`(Fed. Cir. 2005) in which the Federal Circuit held that “means hingedly connecting
`
`said window pane to said mounting flange” must be interpreted under §112, ¶6 be-
`
`cause “[t]he language ‘hingedly connecting’ recites a function, not a particular de-
`
`fined structure.” Id. at 864-865. The phrase “does not recite limited and definable
`
`structure performing the function of ‘hingedly connecting.’” Id. at 866. “In light of
`
`this disclosure, the district court properly construed the limitation ‘means hingedly
`
`connecting’ to require ‘a windowpane connected to a mounting flange using hinge
`
`lugs pivotally secured to cooperable lugs b[y] means of a hinge pin, thus allowing
`
`the window to open and shut by pivoting about a hinge,” and equivalents. Id.
`
`Under Beckson Marine, the means-plus-function limitation should not be
`
`construed using only functional language, such as “hingedly attached” or “hingedly
`
`secured,” but instead must include the structure (fingers or arms) for doing so.
`
`B. Norred Cannot Establish Conception Prior to the Effective Date
`of DiMatteo as a Reference (October 21, 1999)
`
`“Conception is the formulation of a definite and permanent idea of the com-
`
`plete and operative invention as it is hereafter to be applied in practice.” Slip Track
`
`Sys., Inc. v. Metal–Lite, Inc., 304 F.3d 1256, 1262-63 (Fed. Cir. 2002). “Concep-
`
`tion must include every feature or limitation of the claimed invention.” Id. at 1263.
`
`“Inventor testimony alone is insufficient to prove conception; some form of cor-
`
`
`
`4
`
`
`
`roboration must be shown.” Id. Here, Norred relies on a single sketch dated De-
`
`cember 21, 1998 (Ex. 2003) as purporting to show conception of the device of
`
`claims 16-19 prior to the effective date of DiMatteo as a reference (Oct. 21, 1999).
`
`See Response at 6-14; Ex. 2093 (Norred Decl.), ¶¶6-8. However, the sketch fails to
`
`disclose all the elements of claims 16-19.
`
`Norred’s sketch only identifies two elements of a device to be inserted into
`
`the aorta: (1) a “nitinol self-expanding stent” that “expands to the shape of the aor-
`
`ta and sinus;” and (2) a “sutured bioprosthetic valve.” Norred’s argument appears
`
`to impermissibly collapse all the limitations of claim 16 into these two features.
`
`The sketch includes no disclosure of or reference to the valve having a
`
`“ring” of any kind, let alone a “ring member having a circumference adapted to
`
`seat about an aortic wall surrounding an aortic channel” as required by the claims.
`
`Instead, as best Petitioner can determine, Norred has simply taken the sketch, and
`
`annotated it solely for purposes of these proceedings, to draw a heavy circle
`
`around the lower end of the stent, or around the periphery of the “sutured biopros-
`
`thetic valve,” and labeled that “16(a) a ring member.” See Response at 9; Norred
`
`Decl., ¶7. Norred himself examined Fig. 4 of Figulla (Ex. 1013 at 13), which bears
`
`a striking resemblance to the sketch (Ex. 2003), and confidently stated, “this does
`
`not have a membrane outside of that stent system like a ring member” within the
`
`meaning of the claims. Ex. 1010 (Norred Tr.), 85:6-20, 88:13-89:13. If Fig. 4 of
`
`
`
`5
`
`
`
`Figulla does not show the ring member according to Norred, the sketch must also
`
`fail to disclose a ring member.
`
`Moreover, Norred draws a line to the upper section of the aorta and labels
`
`that “16(b)(2) second space-apart open end(s).” See Response at 10; Norred Decl.,
`
`¶7. There is no explanation as to how the upper end of the aorta can correspond to
`
`the “second spaced-apart open end” of a membrane as required by claim 16. In-
`
`deed, a tissue valve (“bioprosthetic valve” in the sketch) includes three leaflets that
`
`open and close like the native valve it replaces; there are no “first and second
`
`spaced-apart open ends” as required by claim 16.
`
`Finally, Norred draws a line to either a strut within the stent or the valve
`
`leaflets (it is not clear) and labels that “16(c) means for mounting.” See Response
`
`at 11; Norred Decl., ¶7. There is no description of any structure that mounts “first
`
`and second spaced-apart open ends” of the tissue in “displaced” relation, and also
`
`“mov[es] said membrane second end between a first open position … and a second
`
`closed position” as required by claim 16. There is no description of the tissue of
`
`the “sutured bioprosthetic valve” being “hingedly secured” or “hingedly attached”
`
`about any ring aperture, as required by the Board’s previous construction of the
`
`limitation. There is no description of any “fingers or arms hingedly attached or
`
`hingedly secured to the ring member and a free end spaced therefrom,” as would
`
`be required under a complete construction of the limitation as discussed above.
`
`
`
`6
`
`
`
`The conclusion that the sketch fails to show conception of the valve of
`
`claims 16-19 is confirmed by the Board’s Decision in which Norred’s failure to
`
`“sufficiently map each claim limitation to supporting evidence,” led the Board to
`
`conclude that “we are not persuaded that the claims of the ’228 patent are entitled
`
`to an earlier priority date.” Decision, at 5-6. The Board noted as an example, that
`
`“Dr. Norred contends that the figure presented in Ex. 2003 is similar to Figure 4 of
`
`the ’228 patent,” “however, that Figure 4 is not relied upon in the ’228 patent to
`
`illustrate the feature of a ring member. See e.g., Ex. 1001, 3:1-13.” Id. at 5-6. In his
`
`Response, Norred again fails to “sufficiently map each claim limitation to support-
`
`ing evidence [Ex. 2003],” choosing instead to rely solely on the same sketch the
`
`Board already considered. The sketch, with or without the recent annotations, is
`
`insufficient to show conception now as it was at the time of the Board’s Decision.
`
`C. Norred Fails to Prove He Was Diligent in Reducing the Claimed
`Invention to Practice During the Critical Period
`
`Norred’s failure to prove conception that predates DiMatteo renders the is-
`
`sue of diligence moot. However, assuming, arguendo, Norred could prove an early
`
`conception date, he would then have to prove diligence during the “critical period”
`
`from October 20, 1999 (a day before DiMatteo’s date) to November 14, 2000 (the
`
`filing date of the ‘228 application). Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572,
`
`1578 (Fed. Cir. 1996) (party must demonstrate reasonable diligence toward reduc-
`
`tion to practice from date just prior to the other party’s invention date).
`
`
`
`7
`
`
`
`During the critical period “there must be continuous exercise of reasonable
`
`diligence.” Iron Dome LLC v. E-Watch, Inc., IPR2014-00439, Paper 16 at 6 (Aug.
`
`4, 2014). Norred, as “[a] party alleging diligence must account for the entire criti-
`
`cal period.” Id. at 6-7. “Even a short period of unexplained inactivity is sufficient
`
`to defeat a claim of diligence.” Id. at 7 (examples of cases in which a lack of rea-
`
`sonable diligence was found based on insufficient activity for a two-day and thir-
`
`teen-day critical period). Moreover, Norred, as “[a] party alleging diligence must
`
`provide corroboration with evidence that is specific both as to facts and dates.” Id.
`
`Norred’s vague and unsupported assertions that he never stopped working
`
`on his invention (see Response at 29) are insufficient to show diligence. Gould v.
`
`Schawlow, 363 F.2d 908, 918 (C.C.P.A. 1966) (“Merely stating that there were no
`
`weeks or months that he ‘did not work on the laser’ is not enough, absent support-
`
`ing facts showing specifically what that ‘work’ consisted of and when it was per-
`
`formed.”). For example, Norred refers to his work with Drs. Hsieh and Lombardo
`
`over nine months from September 1999 to June 2000, to develop a mathematical
`
`model of an aortic stent, but provides no specific dates on which he supposedly
`
`worked on this “project.” Norred Decl., ¶¶36-42. Instead, Norred offers only vague
`
`generalities such as “I met with Dr. Hsieh on a regular basis from September 1999
`
`through March 2000 as often as our schedules would allow” (id., ¶37), but “Dr.
`
`Hsieh was unable to develop the mathematical model” (id., ¶40); and between
`
`
`
`8
`
`
`
`April and June 2000 he and Dr. Lombardo spoke “two or three times per month”
`
`and he “spent 10-15 hours per week” conducting research that he thought might be
`
`helpful to Dr. Lombardo. Id., ¶42. Dr. Lombardo adds only that “[o]ver a period of
`
`weeks, Dr. Norred and I spoke” (Ex. 2096 (Lombardo Decl.), ¶6), but inexplicably
`
`did not begin work on the model until “early-to-mid June, 2000,” over two months
`
`after he first spoke with Norred. Id., ¶7.
`
`Norred also asserts that during a six-month period from May to November
`
`2000, he prepared a proposal for a “fellowship project” related to his invention. See
`
`Response at 19-22; Norred Decl., ¶¶45-48; Ex. 2037, 2041-42, 2051, 2085 (undat-
`
`ed proposal iterations). Norred does not, however, identify specific dates associat-
`
`ed with his work on the proposal, opting instead for imprecise generalities, such as
`
`“[a]s I waited for Mr. Kernell to finish preparing the patent application,” “I worked
`
`on it in some form or fashion every day,” and “it took over 150 hours to complete.”
`
`Norred Decl., ¶¶45, 46, 48.
`
`The absence of specific dates that specific work was performed, and the lack
`
`of sufficient independent corroboration for work done by Norred, precludes a find-
`
`ing of reasonable diligence. See, e.g., ABB v. Roy-G-Biv Corp., IPR2013-00062,
`
`Paper 84 at 13 (Apr. 11, 2014); Garmin v. Cuozzo, IPR2012-00001, Paper 59 at
`
`24-28 (Nov. 13, 2013); Iron Dome, Paper 16 at 6-8. Because there was a lack of
`
`diligence before Norred approached James Kernell to prepare a patent application
`
`
`
`9
`
`
`
`on May 3, 2000 (more than 16 months after Norred prepared the sketch supposedly
`
`reflecting his invention), diligence in preparing the application will not alter the re-
`
`sult. Iron Dome, Paper 16 at 7 (“Even a short period of unexplained inactivity is
`
`sufficient to defeat a claim of diligence.”). Nevertheless, the evidence dictates a
`
`finding that Mr. Kernell was not diligent in preparing the application.
`
`Reasonable diligence can be shown if it is established that the attorney
`
`worked reasonably hard on the particular application in question during the contin-
`
`uous critical period. See Bey v. Kollonitsch, 806 F.2d 1024, 1027-28 (Fed. Cir.
`
`1986). However, the Federal Circuit has “emphasized that the attorney's records
`
`should ‘show the exact days when activity specific to [the patentee's] application
`
`occurred.’ [citation omitted].” In re Enhanced Sec. Research, LLC, 739 F.3d 1347,
`
`1358-59 (Fed. Cir. 2014) (quoting Bey, 806 F.2d at 1028). “[I]f the attorney has a
`
`reasonable backlog of work which he takes up in chronological order and carries
`
`out expeditiously, that is sufficient.” Bey, 806 F.2d at 1028 (quoting, Rines v. Mor-
`
`gan, 250 F.2d 365, 369 (C.C.P.A. 1957)). However, “[g]enerally, the patent attor-
`
`ney must show that unrelated cases are taken up in chronological order, thus, the
`
`attorney has the burden of keeping good records of the dates when cases are dock-
`
`eted as well as the dates when specific work is done on the applications.” Id.
`
`According to Mr. Kernell, the application took approximately 80 hours to
`
`prepare spread out over six months (i.e., May 3, 2000 to November 14, 2000). See
`
`
`
`10
`
`
`
`Ex. 2094 (Kernell Decl.), ¶¶3-5, 12-14, 16-17, 20, 22, 24, 28, 32. No records were
`
`produced, however, regarding the specific dates Mr. Kernell worked on the appli-
`
`cation. Mr. Kernell said he was involved in other matters and he generally “han-
`
`dled each of these matters in chronological order as they were assigned to me to
`
`handle.” Kernell Decl., ¶6. But no records were produced showing that the other
`
`matters were taken up in chronological order, and Mr. Kernell testified that he does
`
`not know when they came into his firm. Ex. 1011 (Kernell Tr.), 48:1-49:5. In the
`
`absence of records regarding when cases were docketed, and the specific dates Mr.
`
`Kernell worked on the ‘228 and other applications, Norred cannot meet his burden
`
`of proving reasonable diligence by Mr. Kernell in preparing the ‘228 application.
`
`Most importantly, the six months it took Mr. Kernell to prepare the ‘228 ap-
`
`plication was inconsistent with his typical practice. Mr. Kernell described his “typ-
`
`ical” practice, followed for most of the applications he prepared during the critical
`
`period, was to pick up an application and prepare it from “start to finish” within
`
`about a two-week period because he “did not let applications become stale” and
`
`applications “wouldn’t have sat around for a long time.” Kernell Tr., 45:21-60:4
`
`(particularly 47:11-25; 51:52:16). The failure to follow this typical practice for the
`
`‘228 application, reflects a lack of reasonable diligence in preparing and filing the
`
`application, whether caused by the conduct of Mr. Kernell, Mr. Norred, or both.
`
`In an effort to overcome the gaps in activity during the critical period,
`
`
`
`11
`
`
`
`Norred suggests that his activities, when combined with those of others (e.g., Dr.
`
`Lombardo and Mr. Kernell), sufficiently reflects “reasonably continuous activity
`
`toward reduction to practice.” Response at 23-24. However, “a party should not be
`
`permitted to pick and choose among spurts of attorney and laboratory activity to
`
`put together a mosaic of activity which happens to cover the critical period.” Kon-
`
`do v. Martel, 223 USPQ 528, 532 (Bd. Pat. Int'f 1984).
`
`II. DIMATTEO ANTICIPATES CLAIMS 16-19
`The Board previously “determined that Medtronic has demonstrated that
`
`there is a reasonable likelihood that it would prevail in showing that DiMatteo [Ex.
`
`1003] anticipates claims 16-19 of the ’228 patent.” Decision at 12. In reaching this
`
`conclusion, the Board correctly rejected Norred’s argument that “ring member”
`
`should be construed “to mean a ring made of a pliable, biocompatible material,”
`
`and “declined to require the ring to be made of any particular material.” Id. at 7-8.
`
`In its Response, Norred asks the Board to reverse itself and rule that a “ring
`
`member” must be made of pliable material, and argues that DiMatteo’s ring mem-
`
`ber is not pliable. Response at 30-36. It is submitted that the Board’s construction
`
`is correct for the reasons stated by the Board, and is also supported by the opinion
`
`of Petitioner’s expert (see Ex. 1018 (Hill Decl.), ¶¶38-42). In any event, the ring
`
`member in DiMatteo is pliable. DiMatteo discloses a ring member within scaffold
`
`30 of support trellis 24, positioned over liner 82, that may be formed from biocom-
`
`
`
`12
`
`
`
`patible, “[s]haped memory alloys having superelastic properties.” Ex. 1003, 7:24-
`
`28,8:60-67, 12:47, 15:7-16:2; see also Paper 4 at Appendix-5. Norred’s expert, Dr.
`
`Catchings, conceded that “super elastic material is pliable.” Ex. 1009 (Catchings
`
`Tr.), 195:8-10. Thus, Norred’s contention that DiMatteo’s ring member is not plia-
`
`ble (Response at 35), is at odds with Dr. Catchings’ definition of “pliable.”
`
`In his declaration, Norred makes a few additional arguments regarding Di-
`
`Matteo that are absent from its Response and, therefore, should not be considered.
`
`See Fidelity Nat'l Info. Servs., Inc. v. DataTreasury Corp., IPR2014-00489, Paper
`
`9 at 9 (Aug. 13, 2014) (37 C.F.R. §§42.22(a)(2) & 42.6(a)(3) prohibit a party from
`
`incorporating by reference information and arguments in supporting documents
`
`that are not also discussed in the brief). One such argument is that DiMatteo’s de-
`
`sign “may work in venous applications, it cannot work within the aorta” (Ex. 2093,
`
`¶70). That argument is baseless as DiMatteo explicitly states that “the present in-
`
`vention relates to implantable … aortic … valves” (Ex. 1003, 1:4-7), and discloses
`
`embodiments of “a prosthetic bicuspid valve 210 … as a replacement aortic valve”
`
`(id., 14:50-58). Other “comments” made by Norred outside of its Response are
`
`equally defective. See Hill Decl., ¶¶56-60.
`
`III. WOLFE ANTICIPATES CLAIMS 16-18
`The Board previously “determine[d] that Medtronic has demonstrated that
`
`there is a reasonable likelihood that it would prevail in showing that Wolfe [Ex.
`
`
`
`13
`
`
`
`1006] anticipates claims 16-18 of the ’228 patent.” Decision at 14.
`
`In his Response, Norred argues that Wolfe’s plastic cuspids are not “mem-
`
`branes.” Response at 37-40. The Board has already rejected that argument. Deci-
`
`sion at 15. Norred offers nothing new in his Response, citing only to a paragraph in
`
`the declaration of Dr. Catchings which in turn cites to the same lines in the ‘228
`
`specification upon which Norred previously relied. See Response at 37; Ex. 2095
`
`(Catchings Decl.), ¶34. Moreover, in his deposition, Dr. Catchings “agree[d] that
`
`the plastic cuspids 38 [of] Wolfe are flexible” and that under a “broad definition”
`
`“the cuspids 38 form a membrane,” and gave no testimony otherwise. Catchings
`
`Tr., 225:8-16. Petitioner’s expert concurs, informing that the cuspids in Wolfe are
`
`“flexible” and comprise a “membrane” as that term would be understood by one of
`
`ordinary skill in the art. Hill Decl., ¶61.
`
`Norred also argues that the structures comprising the “ring member” in
`
`Wolfe are not “pliable.” Response at 38. This argument fails for the same reasons
`
`as it does for DiMatteo. A structure need not be pliable to constitute a “ring mem-
`
`ber.” Decision at 7-8; see also Hill Decl., ¶¶38-42. Moreover, various portions of
`
`the ring member in Wolfe are pliable. Ex. 1006, 3:51-68 (“valve seat assembly 14
`
`includes a soft seating ring 16”); 3:61-62 (“fixation cover 20 [of valve seat assem-
`
`bly 14], which is a Dacron mesh cloth or other suitable material”).
`
`Finally, Norred makes a confusing argument about the cuspid 38 (mem-
`
`
`
`14
`
`
`
`brane) being mounted to annular ring 56 rather than to valve seat assembly 14. Re-
`
`sponse at 39. That is irrelevant. The limitations of claim 16 are met because, re-
`
`gardless of which portion of the ring member the cuspid is mounted to, valve seat
`
`assembly 14 is “seat[ed] about an aortic wall surrounding an aortic channel,” the
`
`cuspid’s first open end is mounted “about said ring aperture,” and its second end is
`
`moved “between a first open position … and a second closed position” as recited
`
`in claim 16. See Paper 4, Appendix 13-15; see also Hill Decl., ¶¶61-64.
`
`Other arguments made only outside of the Response, such as the unfounded
`
`claim that Wolfe only relates to mitral valves (Catchings Tr., 261:17-23) should
`
`not be considered (see Fidelity Nat'l, Paper 9 at 9) and, in any event, are untenable.
`
`See Ex. 1006, 1:49-51 (“the valve assemblies of this invention can also be adapted
`
`to replace … aortic valves.”); see also Ex. Hill Decl., ¶¶61-64.
`
`IV. CONCLUSION
`For the reasons described in the Petition (Paper 4), the Board’s Decision in-
`
`stituting inter partes review (Paper 10), and the above, Petitioner respectfully re-
`
`quests that claims 16-19 of the ‘228 Patent held unpatentable.
`
` Respectfully submitted,
`
`Date: October 24, 2014
`
` PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`/Jack Barufka/
`
`Jack S. Barufka, Reg. No. 37,087
`Tel. No. 703.770.7712; Fax No. 703.905.2500
`
`
`
`
`
`15
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby that the foregoing “Petitioner’s Reply To Patent Owner’s Re-
`
`sponse” was served electronically through the Patent Trial and Appeal Board’s Pa-
`
`tent Review Processing System (PRPS) this 24th day of October, 2014 upon the
`
`lead and back-up counsel for the Patent Owner:
`
`James J. Kernell
`Erickson Kernell Derusseau & Kleypas, LLC
`8900 State Line Road, Suite 500
`Leawood, KS 66206
`
`David Marcus
`Bartle & Marcus LLC
`1100 Main Street, Suite 2730
`Kansas City, MO 64105
`
`
`
`
`
`
` Respectfully submitted,
`
`Date: October 24, 2014
`
` PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`/Jack Barufka/
`
`Jack S. Barufka
`Reg. No. 37,087
`Tel. No. 703.770.7712
`Fax No. 703.905.2500
`
`
`
`
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