`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner
`
`_________________
`
`Case No. IPR2020–00126
`Case No. IPR2020–00127
`U.S. Patent No. 8,048,032
`_________________
`
`PETITIONER’S SUR-REPLY
`TO PATENT OWNER’S CORRECTED MOTION TO AMEND
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`
`
`
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`TABLE OF CONTENTS
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`Page
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`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Proposed Claims 23–25 Are Unpatentable ...................................................... 2
`
`A.
`
`Substitute claims 23–25 are unpatentable over Itou in view of
`Ressemann or Kataishi. ......................................................................... 2
`
`1.
`
`2.
`
`3.
`
`Interventional Cardiology Devices ............................................. 2
`
`Complex Side Opening ............................................................... 4
`
`Size and Coaxial limitations ....................................................... 5
`
`4. Motivation to Combine Itou and Ressemann ............................. 5
`
`5. Motivation to Combine Itou and Kataishi .................................. 8
`
`B.
`
`Substitute claims 23–25 are unpatentable over Kontos in view of
`Ressemann and Takahashi. ................................................................... 8
`
`1.
`
`Interventional Cardiology Devices ............................................. 9
`
`2. Motivation to Combine Kontos and Ressemann ........................ 9
`
`III.
`
`Proposed Claims 23–25 Lack Written Description or are Indefinite. ...........13
`
`A.
`
`The specification lacks description for a side opening outside of
`the substantially rigid portion. .............................................................13
`
`B.
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`Proposed claims 23–25 are indefinite. ................................................15
`
`IV. Conclusion .....................................................................................................15
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`
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`i
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`
`Cordis Corp. v. Medtronic Ave, Inc.,
`339 F.3d 1352 (Fed. Cir. 2003) .......................................................................... 13
`
`Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp.,
`93 F.3d 1572. (Fed. Cir. 1996) ..................................................................... 13, 14
`
`In re Etter,
`756 F.2d 852 (Fed. Cir. 1985) (en banc) .............................................................. 7
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ........................................................................................ 1, 12
`
`Lampi Corp. v. Am. Power Prods., Inc.,
`228 F.3d 1365 (Fed. Cir. 2000) .................................................................... 13, 14
`
`In re Peters,
`723 F.2d 891 (Fed. Cir. 1983) ............................................................................ 13
`
`PowerOasis Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) .................................................................... 13, 14
`
`Univ. of Maryland Biotechnology Institute v. Presens Precision
`Sensing GmbH,
`711 F. App’x 1007 (Fed. Cir. 2017) ................................................................. 1, 6
`
`
`
`
`ii
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`I.
`
`INTRODUCTION
`
`Patent Owner’s (“PO”) inventions are not new—they merely commercialize
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`the prior art. The proposed amended claims add no new material limitations that
`
`were not present in the art and are therefore invalid for the same reasons the original
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`claims are invalid. Before the alleged invention, Kontos described a “guide catheter
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`extension.” Itou, a suction catheter, and Ressemann, an embolic protection device,
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`are both designed to treat coronary artery disease and would be considered together
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`in designing catheters and treating patients. Ressemann and Kataishi disclose the
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`claimed structure of the amended complex side opening and the art attributes known
`
`benefits to this structure. Further, the art describes that similarly shaped openings
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`provide these same benefits when used for both the proximal and distal opening of
`
`various catheters. Nonetheless, PO argues that obviousness is nothing but hindsight.
`
`But a POSITA is not an automaton restricted to combining two specific
`
`physical embodiments of the prior art. Univ. of Maryland Biotechnology Institute v.
`
`Presens Precision Sensing GmbH, 711 F. App’x 1007, 1010 (Fed. Cir. 2017).
`
`Instead, a POSITA has the ordinary creativity of a skilled artisan using the common
`
`knowledge and common sense present in the art. KSR Int’l Co. v. Teleflex Inc., 550
`
`U.S. 398, 421 (2007). PO narrowly focuses on combining specific embodiments and
`
`argues because they are not combinable without making some modifications, the
`
`invention is not obvious. PO ignores that these modifications were well-understood
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`1
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`routine engineering concepts within the capability of a POSITA, who had motivation
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`to make them. Taking well-defined structures with known benefits, like the shape of
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`various catheter openings, and applying those structures to other catheters to achieve
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`predictable results is not inventive. Thus, the proposed amended claims are invalid.
`
`II.
`
`PROPOSED CLAIMS 23–25 ARE UNPATENTABLE
`
`A.
`
`Substitute claims 23–25 are unpatentable over Itou in view of
`Ressemann or Kataishi.
`
`PO argues that the Itou grounds do not invalidate for at least five reasons,
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`including (1) Itou does not disclose all four interventional cardiology devices, (2)
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`Ressemann and Kataishi do not disclose the “concave track,” (3) Itou does not
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`disclose the 0.056 inch inner lumen diameter with a 6 Fr guide catheter, (4) Itou does
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`not disclose the “coaxial lumen,” and (5) a POSITA would not be motivated to
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`combine the references. Each of these issues is discussed below.
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`1.
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`Interventional Cardiology Devices
`
`Itou discloses that all four types of interventional cardiology devices are
`
`insertable.1 First, Itou itself teaches that guidewire (6) is insertable through catheter
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`(2). Ex. 1007, Fig. 5; 4:64-65; see also Ex. 1806 ¶ 45. PO’s expert could have, but
`
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`1 PO incorrectly alleges that Petitioner’s expert agreed the invention requires all four
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`devices. He only agreed with the language recited in the specification that the Board
`
`has already considered. Ex. 2242, 89:1-18; see also id., 208:15-209:10.
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`2
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`did not, offer an opinion on whether a guidewire fit through Itou’s structure. Ex.
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`1805, 139:3-13. Second, the inner diameter of Itou’s tubular portion 24 is 1.5mm, or
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`0.059 inches, Ex. 1007, Table 1, 1:59-65, see also Ex. 1900 ¶¶ 17-18. Even if the
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`“effective opening” of Itou is only 0.046 inches, as PO incorrectly asserts,
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`angioplasty balloons and numerous commercial stents (necessarily deployed using
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`stent catheters) were available before the alleged invention date and were insertable
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`through an opening of at least 0.046 inches. Ex. 1806 ¶¶ 47-52; Ex. 1015b, 189; Ex.
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`1802, 7; Ex. 1803, 4:54-58; Ex. 1804, Table 1 & 2. Indeed, the crossing profiles for
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`13 commercially available stents ranged from 0.84mm (0.033 inches) to 1.17mm
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`(0.046 inches). Ex. 1804, Table 2. Other art of record shows some stents were
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`compatible with even smaller catheters than 5 Fr. See Ex. 1041 at 14 (“Small size (<
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`5 F) guide catheters do not allow for the use of some stents.”) & 22 (“Stent profiles
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`are now very small (profile size of 0.035 and 0.033 inch).”); Ex. 1802, 5-7, 15, 21,
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`& 31 (disclosing stents with crossing profiles less than 1mm or 0.039 inches). 2
`
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`2 PO points to a single example of a commercially available stent requiring a
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`crossing profile of 0.056 inches. See MTA Reply, 11 (citing Ex. 1802, 25). The other
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`cited stents are merely described as being “compatible” with 5 Fr guide catheters,
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`see Ex. 1806 ¶¶ 48-51 (citing Ex. 1048; Ex. 1049), and do not require larger
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`3
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`It is axiomatic that a POSITA would use a suction catheter like Itou to deliver
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`a stent. To begin with, PO’s inventor admitted to starting with the tubular portion of
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`an aspiration catheter while developing GuideLiner because it had the same benefits
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`“whether you’re using it for aspiration or you’re using it for guide extension.” Ex.
`
`1762, 46:4-47:1. And his admission is consistent with a POSITA’s understanding
`
`(and the art’s teaching) to use a suction catheter to both suction a thrombus and
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`deliver a therapeutic device, where appropriate. Ex. 2240, 15:13-16:16 (explaining
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`that “[y]ou’re balancing [the risk of residual material in the suction catheter] against
`
`the risk of the catheter exchange, prolonging the procedure, that itself, as I said, can
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`produce thrombus and introducing air”); Ex. 1019, 3:4-6, 35-38; 12:16-26.
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`2.
`
`Complex Side Opening
`
`It is undisputed that Ressemann’s evacuation sheath includes a support collar
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`with a concave track. (Ex. 1008, 24:54–56, Fig. 16J; Ex. 1900, ¶¶ 20–24.) PO’s own
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`expert, Mr. Keith, testified that if Ressemann’s collar is affixed on top of Itou’s push
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`wire, and the structure of the collar was maintained through the manufacturing
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`process, then that collar would have the claimed concave track. Ex. 1922, 58:6-
`
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`openings. Even assuming Itou’s effective opening is 0.046 inches, a POSITA would
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`readily understand that stents as large as 0.042 inches would “go into that opening
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`without a problem.” Ex. 2239, 180:5-22; 181:2-21, 182:3-22.
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`4
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`59:14, 61:8-12. What PO really disputes is the motivation to make the
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`Itou/Ressemann combination and a POSITA’s expectation of success, discussed
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`below, and not whether the opening itself discloses the claimed features.
`
`Similarly, PO’s expert testified that a POSITA could cut the shape of
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`Kataishi’s opening into Itou’s collar, and if they did, that shape would also have the
`
`claimed concave track. Id., 65:12-23, 66:6-20, 68:9-20. PO’s argument that Kataishi
`
`does not disclose a concave track because of Kataishi’s guidewire lumen is
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`irrelevant—Itou’s primary embodiment does not have a guidewire lumen. A
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`POSITA, motivated to use Kataishi’s opening, is perfectly capable of using the
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`concave track of Kataishi’s opening without including the guidewire lumen.
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`Whether a POSITA would do so is a different question discussed below, but there is
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`no genuine dispute that the structure is nonetheless disclosed in the prior art.
`
`3.
`
`Size and Coaxial limitations
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`PO alleges, without substantive argument, that Itou does not disclose the 6 Fr
`
`guide catheter, 0.056 inner diameter limitations, and “coaxial” limitations. (MTA
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`Reply, 18). The arguments have been briefed previously and should be rejected.
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`4. Motivation to Combine Itou and Ressemann
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`PO argues that a POSITA would not be motivated to combine Itou and
`
`Ressemann for essentially two reasons. First, because a POSITA would not
`
`recognize Ressemann’s collar, part of an embolic protection device, as an
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`5
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`improvement to Itou as a suction catheter. And second, because if Ressemann’s
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`collar was incorporated into Itou, some modifications would be necessary to make
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`them work and these modifications would either destroy the purpose of the
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`references or would amount to hindsight. Both arguments are incorrect.
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`First, a POSITA would undoubtedly look to Itou and Ressemann when
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`designing a catheter. Ex. 1806, ¶¶ 67-69; see also Ex. 1805, 20:7-21:2, 70:13-72:1.
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`More specifically, Ressemann explains that collar 2141 “serves to reinforce the
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`proximal opening of the evacuation lumen 2140.” Ex. 1008, 24:49-55. Taking the
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`defined structure of Ressemann’s collar and incorporating it into Itou would provide
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`the same predictable benefits, including offering a larger area of entry for therapeutic
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`devices. Ex. 1900, ¶¶ 20-61; Ex. 1807, ¶¶ 121-25. The entire structure, including the
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`tab structure PO claims is hidden, would be used because (1) it is already a known
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`structure, (2) it provides a longer and larger surface area for entry of devices, and (3)
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`the tab portion 2141b would provide a flexibility transition and a better connection
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`point to Itou’s pushrod. Ex. 1900, ¶¶ 57-58; Ex. 1807, ¶¶ 121-29.
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`Second, taking the known structure of Ressemann’s collar and incorporating
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`it into Itou would be a matter of routine engineering and would not destroy any
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`purpose of the references. Here, PO misapplies the law of obviousness and ignores
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`routine changes a POSITA would make. “A person of ordinary skill is ‘not an
`
`automaton,’ limited to physically combining references.” Univ. of Maryland
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`6
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`Biotechnology Institute v. Presens Precision Sensing GmbH, 711 F. App’x 1007,
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`1010 (Fed. Cir. 2017) (citations omitted); see also In re Etter, 756 F.2d 852, 859
`
`(Fed. Cir. 1985) (en banc) (“Etter’s assertions that Azure cannot be incorporated in
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`Ambrosio are basically irrelevant, the criterion being not whether the references
`
`could be physically combined but whether the claimed inventions are rendered
`
`obvious by the teachings of the prior art as a whole.”). Instead, a POSITA uses the
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`common knowledge and creativity in the art to make the combination.
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`The process of combining Ressemann’s collar into Itou amounts to nothing
`
`more than routine engineering. For example, a POSITA could place the collar on top
`
`of the pushrod, could taper Itou’s pushwire as it meets the proximal opening, and
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`could apply a polymer coating to Ressemann’s collar to prevent catching of devices.
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`Ex. 1807, ¶ 131. In fact, a POSITA would want to make these changes to create a
`
`better device. Ex. 2241, 27:10-29:7. While PO argues these changes amount to
`
`“hindsight,” its own expert admitted that these concepts were previously used in the
`
`art at the time of the invention and would be within the knowledge of a POSITA.
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`Ex. 1922, 29:17-22 (adhesives were well known), 29:23-30:16 (polymer coatings
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`were known), 31:13-32:6 (tapering was known and “some sort of methodology to
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`try and get rid of that obstruction does make sense”). Other ways existed to affix the
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`collar, including following Itou’s disclosure of coating the surfaces with resin and
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`welding the collar to the distal end of the pushwire. See Ex. 1007, 4:32-36.
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`7
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`5. Motivation to Combine Itou and Kataishi
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`PO’s main argument for Kataishi is that a POSITA would not look towards
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`Kataishi’s distal opening to use in a proximal opening of Itou. This motivation comes
`
`directly from the art itself, namely Ressemann, which teaches that an angled shape
`
`for both the proximal and distal ends of a catheter provides similar benefits:
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`The proximal and distal ends 140a, 140b of the evacuation lumen 140
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`are preferably angled to allow for smoother passage of the evacuation
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`sheath assembly 100 through a guide catheter, and into a blood vessel,
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`and to facilitate smoother passage of other therapeutic devices through
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`the evacuation lumen 140 of the evacuation head 132. The larger area
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`of the angled open ends also allows for larger deformable particulate
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`matter to pass through the lumen more smoothly.
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`Ex. 1008 6:52-60 (emphasis added). Kataishi and other art shows that Kataishi’s
`
`shape has improved crossability in the vasculature, Ex. 1055, 300-02, and a POSITA
`
`would recognize this benefit applies to the proximal opening as well. Ex. 1807,
`
`¶ 198. Further, Kataishi discloses predictable benefits in a proximal opening, i.e. the
`
`shape improves suction of thrombi with a larger area of entry. Ex. 1900 ¶¶ 108-17.
`
`B.
`
`Substitute claims 23–25 are unpatentable over Kontos in view of
`Ressemann and Takahashi.
`
`PO argues that the Kontos grounds do not invalidate substitute claims 23-25
`
`for similar reasons as the Itou grounds, including (1) the grounds do not disclose two
`
`interventional cardiology devices and (2) a POSITA would not be motivated to
`
`8
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`combine the references. Each of these issues is discussed below.
`
`1.
`
`Interventional Cardiology Devices
`
`PO argues that even though Ressemann discloses passing stents, combining
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`Ressemann’s collar with Kontos might create a catch point and thus the invention is
`
`invalid. (MTA Reply, 19). The arguments do not logically flow together and ignore
`
`routine modifications a POSITA would make to prevent catch points.
`
`First, PO does not dispute that in the 2005-2006 timeframe, stents were sized
`
`to travel through Kontos. Ex. 1806 ¶¶155-58; Ex. 1015a, 32; Ex. 1802, 6-7, 15, 21,
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`25; Ex. 2116, 335:18-336:1. PO incorrectly argues that Ressemann requires a reverse
`
`bevel to pass stents, and thus, without a reverse bevel in the Kontos/Ressemann
`
`combination, it cannot pass stents. But PO’s expert admitted that Ressemann’s
`
`primary embodiment does not use a reverse bevel. Ex. 1801, 107:1-108:4; see also
`
`Ex. 2241, 48:11-49:1. Nor does the expert’s own patent—with verbatim disclosures
`
`from Ressemann about passing devices through a side opening—use a reverse bevel.
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`Ex. 1800, 149:3-10. And in combining Kontos with Ressemann, a POSITA would
`
`use routine engineering to encase the collar in a polymer coating to eliminate any
`
`catch points. Ex. 1807, ¶¶ 90-92, 188-190. PO’s expert agreed that polymer coatings
`
`were known in the art, Ex. 1922, 29:23-30:16, and PO’s arguments are unpersuasive.
`
`2. Motivation to Combine Kontos and Ressemann
`
`PO’s arguments on motivation to combine essentially are that (1) a POSITA
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`would not be motivated to remove Kontos’s funnel because it would conflict “with
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`Kontos’s stated purposes of acting as a temporary stent . . . and of functioning as a
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`‘support catheter,’”(MTA Reply, 20), and (2) significant modifications would need
`
`to be made to maximize the inner lumen diameter as proposed by Petitioner. PO
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`defines the purpose of Kontos too narrowly, as Kontos has other functions besides
`
`acting as a temporary stent, including to deliver a PTCA catheter. Further,
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`Petitioner’s proposed modification only increases the outer diameter of Kontos’s
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`extension catheter by 0.008 inches. Compare Ex. 1807, ¶ 73, with id. ¶ 194. Second,
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`the proposed modifications to Kontos are not significant redesigns of the reference,
`
`as PO alleges, but instead are routine engineering concepts applied to manufacture
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`a working device. PO’s assumption that the proposed changes to Kontos are
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`hindsight bias and not routine engineering are not supported by the facts or the law.
`
`The motivation to combine comes directly from the prior art. Takahashi
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`discloses that using a 5 Fr “guiding catheter” inside of a 6 Fr “guiding catheter”
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`increases backup support. Ex. 1010, 5. Specifically, the reference discloses that
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`extending a 5 Fr guide catheter just 10mm beyond the 6 Fr guide catheter increases
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`the maximum backup support by almost double compared with a 6 Fr guide catheter
`
`by itself. Id., 7, Fig. 4. PO does not dispute that Takahashi provides motivation to
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`achieve a 1 French differential to increase backup support. Ex. 1801, 117:14-118:5.
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`Instead, PO only alleges that because Kontos already fit within a 6 Fr guide catheter
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`and provided some backup support, a POSITA would not be motivated to modify
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`the reference to provide more backup support. (MTA Reply, 24).
`
`As disclosed in Ressemann, a POSITA would understand that Ressemann’s
`
`collar would provide better benefits over Kontos’s funnel in allowing more types of
`
`interventional cardiology devices to pass through. Ex. 1900, ¶¶ 152-55; Ex. 1905,
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`¶¶ 96-97. A POSITA would also understand that removing the funnel would provide
`
`the additional benefit to allow for a larger inner diameter without needing a larger
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`outer diameter. Ex. 1900, ¶¶ 167-70. This allows for larger devices or more device
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`clearance through the same size outer diameter guide catheter, a sought after benefit
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`to better treat patients. Id.
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`PO argues that modifying Kontos in this manner would include too many
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`changes, like making the distal tip flush with the rest of the catheter, removing the
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`protruding marker bands and recessing them into the body of the catheter, tapering
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`the guidewire, and reinforcing the catheter with braiding. (MTA Reply, 22.) PO
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`again ignores that each of these steps is well within the ordinary routine engineering
`
`of a POSITA. These arguments are inconsequential and distract from the key
`
`question—whether a POSITA would be motivated to take the defined structure of
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`Ressemann’s collar with the known benefits of aiding delivery of interventional
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`cardiology devices and incorporate that structure into Kontos’s “guide catheter
`
`extension” with an expectation of success. Where this motivation comes directly
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`from the art and the combination is nothing more than routine engineering, the
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`proposed amended claims are invalid as obvious.
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`Petitioner’s experts testified that recessing Kontos’s marker bands could (and
`
`would) easily be accomplished to maximize the inner lumen of the catheter. Ex.
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`1900, ¶¶ 179–80; Ex. 2116, 343:5-136, 346:12-25, 353:24-354:17, & 364:3-365:11
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`(testifying why a POSITA would want to remove protruding marker bands);
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`Ex. 2137, 464:19-467:2 (testifying that Kontos itself discloses “numerous other
`
`methods of disposing marker band 30” onto tube 16). Tapering was a well-
`
`understood concept and a POSITA would taper the guidewire to incorporate
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`Ressemann’s collar. (Ex. 1900, ¶¶ 161; Ex. 1807, ¶¶ 177.) Contrary to PO’s
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`argument, this tapered guidewire would not be too flimsy to work. See Ex. 1922,
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`31:13-32:6 (PO’s expert testifying that tapering was known to a POSITA). 3 Other
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`changes, like reinforcing the catheter with braiding, are nothing more than using
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`familiar and known elements in predictable ways to achieve known benefits. Ex.
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`1900, ¶¶ 190-98; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
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`(“The combination of familiar elements according to known methods is likely to be
`
`obvious when it does no more than yield predictable results.”).
`
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`3 Dr. Jones is not inconsistent on tapering. He testified he would taper Kontos over
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`a long distance, as opposed to the abrupt tapering in Itou. Ex. 2241, 133:6-134:3.
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`III. PROPOSED CLAIMS 23–25 LACK WRITTEN DESCRIPTION OR
`ARE INDEFINITE.
`
`A. The specification lacks description for a side opening outside of the
`substantially rigid portion.
`
`It is axiomatic that the specification must “actually or inherently disclose[] the
`
`claim element[s].” PowerOasis Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306–07
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`(Fed. Cir. 2008). PO’s argument that claims may be broader than the preferred
`
`embodiments (MTA Reply, 1–2) misses the mark. While an applicant may choose
`
`to exclude certain features of the preferred embodiment from the claims, a recited
`
`element must be disclosed by the specification. Ethicon Endo-Surgery, Inc. v. U.S.
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`Surgical Corp., 93 F.3d 1572, 1582 n.7. (Fed. Cir. 1996). Here, proposed claim 23
`
`recites a “device for use with a standard 6 French guide catheter . . . comprising, in
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`a distal-to-proximal direction . . . a flexible tip portion . . . [a] side opening . . . and
`
`a substantially rigid portion.” (App., 1–2.) Thus, this case does not involve claims
`
`that “merely omit an unnecessary limitation.” In re Peters, 723 F.2d 891, 893 (Fed.
`
`Cir. 1983) (emphasis added) (broadening claim on reissue by eliminating recitation
`
`of the shape of a tip, where specification discloses a tapered tip).
`
`For this reason, PO’s cited cases are not persuasive. See e.g., Cordis Corp. v.
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`Medtronic Ave, Inc., 339 F.3d 1352, 1364–65 (Fed. Cir. 2003) (noting that
`
`specification defined “slots” to include “[b]oth half slots and complete slots”);
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`Lampi Corp. v. Am. Power Prods., Inc., 228 F.3d 1365, 1377–78 (Fed. Cir. 2000)
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`(explaining that specification’s “references to half-shells without the modifier
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`‘identical’ or ‘identically shaped’” provided support). To the contrary, the proposed
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`amended claims each include an undescribed limitation. In particular, each claim
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`recites the side opening outside of the substantially rigid portion/segment.
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`Whether “the technology is unpredictable” or the unclaimed aspect is “critical
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`to the invention” (MTA Reply, 2-3) is inapposite here because a side opening outside
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`of the substantially rigid segment is not an “unclaimed aspect.” Id. A recited claim
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`element must be actually or inherently disclosed. PowerOasis, 522 F.3d at 1306–07;
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`Ethicon, 93 F.3d at 1582 n.7 (stating that the examiner “properly rejected [the claim]
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`because it recited an element not supported by [the specification]”). PO’s expert
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`agrees that the side opening in Figures 4 and 12 is always in the rigid portion 20. Ex.
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`1922, 8:15-9:8. Further, PO’s expert could not point to a specific description of any
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`embodiment with a side opening outside of the rigid portion 20, id., 10:19-11:20 (“I
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`don’t think there’s that specific example described.”), or of rigid portion 20 being
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`made out of anything other than a single tube. Id., 14:6-22 (“I think one of skill in
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`the art would read this and understand that there are other ways that one could do
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`that, but they are not specifically described in the specification.”).
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`PO’s argument that a side opening can be made less rigid is irrelevant. (MTA
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`Reply, 6.) This is not a question of enablement. The legally relevant inquiry is
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`whether a POSITA would have understood the inventor(s) to have possession of a
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`device with a side opening outside of the substantially rigid portion, as claimed. PO
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`does not dispute that the specification exclusively and consistently describes the side
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`opening as located in the substantially rigid portion. Instead, PO argues that “[w]here
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`the side opening is [made] less rigid [e.g., by relief cuts] than the tube that is just
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`distal to it, it makes little sense to require that the side opening be in ‘the substantially
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`rigid portion.’” (MTA Reply, 6.) The mere fact that the side opening can be made
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`less rigid does not show that a POSITA would have understood the inventor(s) to
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`have had possession of a device with a side opening outside of the substantially rigid
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`portion.
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`B.
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`Proposed claims 23–25 are indefinite.
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`Proposed claim 23 recites that the length of the substantially rigid portion
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`“when combined with the length of the flexible . . . tip portion, defines a total length
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`of the device.” (App. 1-2). Thus, as claimed, the device’s total length comes from
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`just two components. But the proposed claim includes three components arranged
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`“in a distal-to-proximal direction,” including (1) “a flexible tip portion,” (2) a “side
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`opening,” and (3) “a substantially rigid portion.” (Id.) On its face, the claim is
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`indefinite, and proposed claims 24 and 25 fare no better.
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`IV. CONCLUSION
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`For the foregoing reasons, Teleflex’s motion to amend should be denied.
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`RESPECTFULLY SUBMITTED,
`
`ROBINS KAPLAN LLP
`
`/ Cyrus A. Morton /
`Cyrus A. Morton
`800 LaSalle Ave, Suite 2800
`Minneapolis, MN 55402
`(612) 349–8500
`Attorney for Petitioner
`
`
`
`
`Date: February 23, 2021
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this February 23, 2021, a copy of Petitioner’s
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`Opposition to Patent Owner’s Corrected Motion to Amend was served in its
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`entirety by electronic mail on Patent Owner’s counsel at the following addresses
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`indicated in Patent Owner’s Mandatory Notices:
`
`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
`
`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
`
`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
`
`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
`
`Tara C. Norgard (pro hac vice pending)
`tnorgard@carlsoncaspers.com
`
`Alexander S. Rinn (pro hac vice pending)
`pkohlhepp@carlsoncaspers.com
`
`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
`
`Kenneth E. Levitt, Reg. No. 39,747
`levitt.kenneth@dorsey.com
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`Dated: February 23, 2021
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`
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`
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`Respectfully submitted,
`
`/Cyrus A. Morton/
`Cyrus A. Morton
`Reg. No. 44,954
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