`
`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. IPR2020-00135
`Case No. IPR2020-00136
`U.S. Patent No. RE45,776
`_________________
`
`PETITIONER’S SUR-REPLY
`TO PATENT OWNER’S CORRECTED MOTION TO AMEND
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`
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`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
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`TABLE OF CONTENTS
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`Page
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Proposed Claims 58-65 Are Unpatentable. ..................................................... 2
`
`A.
`
`Substitute claims 58-65 are unpatentable over Itou in view of
`Ressemann and/or Kataishi or over Itou in view of Ressemann
`or Kataishi and Eidenschink. ................................................................. 2
`
`1.
`
`2.
`
`3.
`
`Stents and Stent Catheters ........................................................... 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 58-65 are unpatentable over Kontos in view of
`Ressemann, over Kontos
`in view of Ressemann and
`Eidenschink, or over Kontos in view of Ressemann and
`Takahashi. .............................................................................................. 8
`
`1.
`
`Stents and Stent Catheters ........................................................... 9
`
`2. Motivation to Combine Kontos and Ressemann ........................ 9
`
`III.
`
`Proposed Claims 58-62 and 65 Lack Written Description Support. .............13
`
`IV. Proposed Claim 65 is a Broadening Amendment .........................................15
`
`V.
`
`Conclusion .....................................................................................................15
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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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`I.
`
`INTRODUCTION
`
`Patent Owner’s (“PO”) inventions are not new—they merely commercialize
`
`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
`
`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
`
`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
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`argues because they are not combinable without making some modifications, the
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`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 58-65 ARE UNPATENTABLE.
`
`A.
`
`Substitute claims 58-65 are unpatentable over Itou in view of
`Ressemann and/or Kataishi or over Itou in view of Ressemann or
`Kataishi and Eidenschink.
`
`PO argues that the Itou grounds do not invalidate for at least five reasons, (1)
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`Itou does not disclose stents, (2) Ressemann and Kataishi do not disclose the
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`“concave track,” (3) Itou does not disclose a 0.056 inner diameter with a 6 Fr guide
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`catheter, (4) Itou does not disclose the “coaxial lumen,” and (5) a POSITA would
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`not be motivated to combine the references. Each is discussed below.
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`1.
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`Stents and Stent Catheters
`
`Itou discloses that all four types of interventional cardiology devices are
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`insertable, including stents. First, Itou itself teaches that guidewire (6) is insertable
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`through catheter (2). Ex. 1007, Fig. 5; 4:64-65; see also Ex. 1806 ¶ 45. PO’s expert
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`could have, but did not, offer an opinion on whether a guidewire fit through Itou’s
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`structure. Ex. 1805, 139:3-13. Second, the inner diameter of Itou’s tubular portion
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`24 is 1.5mm, or 0.059 inches, Ex. 1007, Table 1, 1:59-65, see also Ex. 1904, ¶¶ 27-
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`28. Even if the “effective opening” of Itou is only 0.046 inches, as PO incorrectly
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`2
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`asserts, angioplasty balloons and numerous commercial stents (necessarily deployed
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`using stent catheters) were available before the alleged invention date and were
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`insertable through an opening of at least 0.046 inches. Ex. 1806 ¶¶ 47-52; Ex. 1015b,
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`189; Ex. 1802, 7; Ex. 1803, 4:54-58 (IPR2020-00126); Ex. 1804, Table 1 & 2.
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`Indeed, the crossing profiles for 13 commercially available stents ranged from
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`0.84mm (0.033 inches) to 1.17mm (0.046 inches).1 Ex. 1804, Table 2. Other art of
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`record shows some stents were compatible with even smaller catheters than 5
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`French. See Ex. 1041 at 14 (“Small size (< 5 F) guide catheters do not allow for the
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`use of some stents.”) & 22 (“Stent profiles are now very small (profile size of 0.035
`
`and 0.033 inch).”); Ex. 1802, 5-7, 15, 21, & 31 (disclosing stents with crossing
`
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`1 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, 15 (citing Ex. 1802, 25).
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`Otherwise, cited stents are merely described as being “compatible” with 5 Fr guide
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`catheters, see Ex. 1806 ¶¶ 48-51 (citing Ex. 1048; Ex. 1049), which were often the
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`smallest commercially available guide catheters in the early 2000s. Regardless, as
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`Petitioner’s expert testified, and as the record evidence shows, even assuming Itou’s
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`effective opening is only 0.046 inches, a POSITA would readily understand that
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`commercially available 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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`3
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`profiles less than 1mm or 0.039 inches).
`
`It is axiomatic that a POSITA would use a suction catheter like Itou to deliver
`
`a stent. Itou teaches placing the catheter in exactly the right place to deliver a stent,
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`where its distal tubular opening is adjacent “foreign matter” in the coronary artery.
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`Ex. 1007, Fig. 6; 1:66-2:5; 5:29-42. Moreover, inventor Root admitted to starting
`
`with the tubular portion of an aspiration catheter while developing GuideLiner
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`because it had the same benefits “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
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`both suction a thrombus and deliver a therapeutic device, where appropriate. Ex.
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`2240, 15:13-16:16 (explaining that “[y]ou’re balancing [the risk of residual material
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`in the suction catheter] against the risk of the catheter exchange, prolonging the
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`procedure, that itself, as I said, can produce thrombus and introducing air”); Ex.
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`1019, 3:4-6, 35-38; 12:16-26.
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`2.
`
`Complex Side Opening
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`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. 1904, ¶¶ 23-25.) 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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`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.
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`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
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`claimed concave track. Id., 65:12-23, 66:6-20, 68:9-20. PO’s argument that Kataishi
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`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, and “coaxial” limitations. (MTA Reply, 16-
`
`17). 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. 1904, ¶¶ 23-38; 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
`
`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. 1904, ¶¶ 37-38; 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
`
`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
`
`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
`
`common knowledge and creativity in the art to make the combination.
`
`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
`
`were known), 31:13-32:6 (tapering was known and “some sort of methodology to
`
`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
`
`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
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`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
`
`are preferably angled to allow for smoother passage of the evacuation
`
`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
`
`the evacuation lumen 140 of the evacuation head 132. The larger area
`
`of the angled open ends also allows for larger deformable particulate
`
`matter to pass through the lumen more smoothly.
`
`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. 1904 ¶¶ 93-101.
`
`B.
`
`Substitute claims 58-65 are unpatentable over Kontos in view of
`Ressemann, over Kontos in view of Ressemann and Eidenschink,
`or over Kontos in view of Ressemann and Takahashi.
`
`PO argues that the Kontos grounds do not invalidate substitute claims 58-65
`
`for similar reasons as the Itou grounds, including (1) the grounds do not disclose
`
`stents and (2) a POSITA would not be motivated to combine the references. Each of
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`8
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`these issues is discussed below.
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`1.
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`Stents and Stent Catheters
`
`PO argues that even though Ressemann discloses passing stents, combining
`
`Ressemann’s collar with Kontos might create a catch point and thus the claims are
`
`not invalid. (MTA Reply, 20-21). 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.
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`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, 19), 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
`
`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
`
`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, 25).
`
`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. 1904, ¶¶ 143-57; 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
`
`outer diameter. Ex. 1904, ¶¶ 146-48. 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, 23.) 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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`1904, ¶ 188; 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. 1904, ¶ 188; Ex. 1807, ¶ 177.) Contrary to PO’s argument,
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`this tapered guidewire would not be too flimsy to work. See Ex. 1922, 31:13-32:6
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`(PO’s expert testifying that tapering was known to a POSITA). 2 Other changes, like
`
`reinforcing the catheter with braiding, are nothing more than using familiar and
`
`known elements in predictable ways to achieve known benefits. Ex. 1904, ¶¶ 55 &
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`192-200; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The
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`combination of familiar elements according to known methods is likely to be
`
`obvious when it does no more than yield predictable results.”).
`
`
`2 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 58-62 AND 65 LACK WRITTEN
`DESCRIPTION SUPPORT.
`
`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, thereby
`
`rendering the claims broader than the preferred embodiments, a recited claim
`
`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, the claims explicitly
`
`recite “a segment defining a partially cylindrical opening positioned between a distal
`
`end of the substantially rigid segment and a proximal end of the tubular structure.”
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`(Ex. 1001, 13:36-49, 15:15-28; App., 1-3.) Thus, this case does not involve claims
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`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.
`
`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,”
`
`meaning that claim reciting “plurality of slots” was not limited to the preferred
`
`embodiment containing alternating complete and half slots); Lampi Corp. v. Am.
`13
`
`
`
`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
`
`Power Prods., Inc., 228 F.3d 1365, 1377-78 (Fed. Cir. 2000) (explaining that
`
`specification’s “references to half-shells without the modifier ‘identical’ or
`
`‘identically shaped’” provided support for claim covering non-identical half-shells
`
`despite preferred embodiment showing only identical half shells). To the contrary,
`
`the proposed amended claims each include an undescribed limitation. In particular,
`
`each claim recites the side opening outside of the substantially rigid portion/segment.
`
`Whether “the technology is unpredictable” or the unclaimed aspect is “critical
`
`to the invention” (MTA Reply, 2-3) is inapposite here because a side opening outside
`
`of the substantially rigid segment is not an “unclaimed aspect.” Id. A recited claim
`
`element must be actually or inherently disclosed. PowerOasis, 522 F.3d at 1306-07;
`
`Ethicon, 93 F.3d at 1582 n.7 (stating that the examiner “properly rejected [the claim]
`
`because it recited an element not supported by [the specification]”). PO’s expert
`
`agrees that the side opening in Figures 4 and 12 is always in the rigid portion 20. Ex.
`
`1922, 8:15-9:8. Further, PO’s expert could not point to a specific description of any
`
`embodiment with a side opening outside of the rigid portion 20, id., 10:19-11:20 (“I
`
`don’t think there’s that specific example described.”), or of rigid portion 20 being
`
`made out of anything other than a single tube. Id., 14:6-22 (“I think one of skill in
`
`the art would read this and understand that there are other ways that one could do
`
`that, but they are not specifically described in the specification.”).
`
`PO’s argument that a side opening can be made less rigid is irrelevant. (MTA
`
`14
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`
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`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
`
`Reply, 5-6.) This is not a question of enablement. The legally relevant inquiry is
`
`whether a POSITA would have understood the inventor(s) to have possession of a
`
`device as claimed. PO does not dispute that the specification exclusively and
`
`consistently describes the side opening as located in the substantially rigid segment.
`
`Instead, PO argues that “[w]here the side opening is [made] less rigid [e.g., by relief
`
`cuts] than the tube that is just distal to it, it makes little sense to require that the side
`
`opening be in ‘the substantially rigid portion.’” (MTA Reply, 6.) The mere fact that
`
`the side opening can be made less rigid does not show that a POSITA would have
`
`understood the inventor(s) to have had possession of a device with a side opening
`
`outside of the substantially rigid segment.
`
`IV. PROPOSED CLAIM 65 IS A BROADENING AMENDMENT
`
`PO does not dispute that proposed claim 65 permits the distance between the
`
`inner diameter of the tubular structure and the inner diameter of the guide catheter
`
`to be 0.014 inches. (MTA Reply, 7-8.) Nor does PO dispute that original claim 56
`
`required a “1 French” differential, which, as measured “mathematical[ly, is a]
`
`difference of . . . 0.0131 inches.” (See, e.g., Ex. 2243, ¶ 48.) As previously briefed,
`
`PO’s argument—that 1 Fr means something other than 1 Fr—should be rejected, and
`
`the Board should find that proposed claim 65 is a broadening amendment.
`
`V. CONCLUSION
`
`For the foregoing reasons, Teleflex’s motion to amend should be denied.
`
`15
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`
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`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
`
`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
`
`
`
`
`
`
`
`
`
`
`16
`
`
`
`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on this February 23, 2021, a copy of Petitioner’s Sur-
`
`Reply to Patent Owner’s Corrected Motion to Amend was served in its entirety by
`
`electronic mail on Patent Owner’s counsel at the following addresses 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
`
`Dated: February 23, 2021
`
`
`
`
`
`Respectfully submitted,
`
`/Cyrus A. Morton/
`Cyrus A. Morton
`Reg. No. 44,954
`
`
`
`
`
`17
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`
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