`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`_ The ‘880 Patent
`Mihara (Exh. 1009)
`
`lumen ofthe guide
`| catheter, such that when at
`| least a distal portion ofthe
`| flexible tip portion is
`_ extended distallyofthe
`| distal end of the guide
`| catheter, at least a portion
`_ of the proximal portion of
`| the substantiallyrigid
`_ portion extends proximally
`| throughthe hemostatic
`| valve m common with
`_ interventional cardiology
`_ devices that are insertable
`| into the guide catheter.
`
`2. The systemofclaim {,
`"wherein the tubular
`_ structure includes a distal
`portion adapted to be
`_extended beyond the distal
`_end ofthe guide catheter
`| while a proximal portion
`_remains within the lumen
`_ofthe guide catheter,
`
`
`
` wt
`
`
`Compare 1006, [0092]: (the guiding catheter6
`(Heart Rail 6, produced by Terumo Corp.; having an
`immer diameter of 1.8 mmand a length of 100 cm)”),
`with [0034] (The entire length of the catheter 1 is
`not particularly limited, but preferably in the range of
`900 to 1700 mm, and more preferably m the range of
`1100 to 11580 mm”); see [0073]-[0075] (Length of
`the wire 2: 1060 mrm[;] Length of L2: 10 mimn];]
`Length of Li: 250 mm”}
`Miharadiscloses the device of claim | (see above)
`
`
`
`Page 378
`
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`
`Page 378
`
`Medtronic Exhibit 1803
`
`

`

`
`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`_ The ‘880 Patent
`Mihara Uixh. 1009)
`“As shown in Table 1, it was confirmed that the
`catheter of the present invention (Example 1) has a
`high striking resistance and an excellent push-in
`property, compared with the catheter with the guide
`wire lumen formed overthe entire length of the
`catheter (Comparative Example}.” (Exh. 1009,
`[O100)). “An object of the present invention is to
`provide a catheter excellent in push-tn property,
`capable of easily and rapidly penetrating a stenotic
`lesion....” (Exh. 1009, [O010]}. “As described below,
`the catheter of the present mmvention has an excellent
`push-in property. Therefore, a push-in force applied
`from a proximal end side is transmitted to a distal end
`portion exactly, and as a result, the catheter can
`penetrate a stenotic lesion occurred in a lumen in the
`human body easily and rapidly.” (Exh. 1009, [0024)).
`
`| wherein the tubular
`_
`structure includes a distal
`
`ortion adapted to be
`
`extended beyond the distal
`_
`_end ofthe guide catheter
`_ while a proximal portion
`| remains within the lumen
`_ of the guide catheter, such
`_ that the device assists in
`_ resisting axial and shear
`_
`forces exerted by the
`
`| interventional cardiology
`_ device passed through and
`beyond the coaxial lumen
`| that would otherwise tend
`to dislodge the guide
`| catheter fromthe branch
`artery.
`
`Mihara discloses the device of claim2. (see above} 3. The device of claim 2
`_ wherein the proximal
`Annotated Fig. 2 (below) of Mihara discloses a
`
`| portion of the tubular
`catheter wherein the proximal side opening to the
`
`_ structure further comprises
`hollowdevice lumen (31) ofthe tubular body(3) is
`|
`tructure defining a
`skived or cut at an angle, forming structure defining a
`
`|" proximal side opening
`proximal side opening extending for a distance along
`_ extending for a distance
`the longitudinal axis and accessible from a
`_along the longitudinal axis,
`longitudinal side defined transverse to the
`longitudinal axis. (Exh. 1009, Fig. 1}.
`_ and accessible trom a
`| longiudimal side defined
`_ transverse to the
`| longitudinal axis,
`
`Page 379
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`
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`
`

`

`
`
`_ The ‘880 Patent
`
`Claim Chart A-1: Cls. 1. 2, 3,
`Mihara (Exh. 1009)
`
`4,12, 14 in viewof
`
`
`
`“The hollow portion 31 of the tubular body3 is
`opened to the distal end and the proximal end ofthe
`tubular body 3, whereby a guide wire can be inserted
`(penetrate) in the hollow portion 31.” CExh. 1009,
`{0049}.
`
`s the device of claim 3
`
`Annotated Fig. 2“F (below) ofMihara discloses a
`
`. (see above)
`
`catheter wherem the proximal side opening to the
`hollowdevice lumen (31) of the tubular body(3) is
`skived or cut at an angle, forming structure defining a
`full circumference portion andstructure defining a
`partially cylindrical portion:
`
`
`| to receivean interventional
`cardiology device into the
`coaxial lumen while the
`| proximal portion remains
`_ within the lumen ofthe
`uide catheter.
`A, The system of claim 3
`owherein the proximal side
`_ opening includesstructure
`| defining a full
`_ circumference portion and
`| structure defining a
`| partially cylindrical
`"portion.
`
`Mihara disclos
`
`PEG.2
`
`a A systemfor use with
`_interventional cardiology
`
`[i] To the extent that the preamble IS a:limitation.
`Miharadiscloses a device for use with “guiding
`
`
`
`Page 380
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`
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`
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`
`

`

`
`
`_ The ‘880 Patent
`
`_ devices adapted to be
`_insertable into a branch
`_artery, the system
`| comprising:
`_a guide catheter having a
`_ continuous lumen
`| extending for a predefined
`length from a proximal end
`| at a hemostatic valve to a
`_ distal end adapted to be
`_ placed inthe branchartery,
`| the continuous lumen of
`_ the guide catheter having a
`circular cross-section and a
`| cross-sectional immer
`_ diametersized such that
`| interventional cardiology
`_ devices are insertable into
`_ aad through the continuous
`| lumen of the guide
`_catheter; and
`
`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`Mihara Uixh. 1009)
`catheter 6” Gee dashed blue line in annotated Fig. 3
`below) having a continuous lumen extending for a
`predefined length from a proximal end to a distal end
`adapted to be placed in a branchartery:
`
`PIG.R
`
`“First, the guiding catheter 6 ... primed with distilled
`water was bent in a shape as shown in FIG, 3 to
`produce a blood vessel model. The distal end of the
`guiding catheter 6 was placed at a position that was
`assumed to be engaged with an entrance of the
`coronary artery.” (Exh, 1009, [0092 ]}.
`
`[2] As shown im annotated Fig. 3 above, Mihara
`discloses that the lumen of the guide catheter 6 has a
`circular cross-section that is sized to allowfor
`interventional cardiology devices (such as guide wire
`7) to be passed therethrough and into a branchartery.
`“First the guidme catheter 6... having an inner
`diameter of 1.8 mm...was bent in a shape as shown
`im Fig. 3 to produce a blood vessel model. The distal
`end of the guiding catheter 6 was placed at a position
`that was assumed to be engaged with an entrance of
`the coronaryartery. Then, the guide wire 7...was
`
`>»
`
`Lane
`
`Page 381
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`
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`
`

`

`
`| The ‘880 Patent
`Claim Chart A-[: Cls. 1, 2, 3, 4, 12. 14 in viewof
`Mihara Uixh. 1009)
`mserted m the tubular body3 of the above-described
`catheter 1, After that, the catheter | was inserted in
`the guiding catheter together with the guide wire 7.”
`(Exh, 1009, [0092]-[0063p.
`
`“First, the guiding catheter 6 ... primedwith distilled
`water was bent ima shape as shown in FIG, 3 to
`produce a blood vessel model. The distal end of the
`guiding catheter 6 was placed at a position that was
`assumed to be engaged with an entrance ofthe
`coronaryartery.” (Exh, 1009, [0092 ]}.
`
`[2] As shownin annotated Fig. 3 below, the guide
`catheter 6 used with the Mihara device has a
`continuous central lumen
`
`“First the guiding catheter 6... having an inner
`
`[4] As shown in annotated Fig. 3 below, Mihara
`discloses that the lumen of the guide catheter 6 has a
`circular cross-section that is sized to allowfor
`interventional cardiology devices (such as guide wire
`7) to be passed therethrough and into a branchartery.
`
`Page 382
`
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`
`Page 382
`
`Medtronic Exhibit 1803
`
`

`

`
`
`_ The ‘880 Patent
`
`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`Mihara Giuxh. 1009)
`diameter of 1.8 mm...was bent in a shape as shown
`m Fig, 3 to produce a blood vessel model. The distal
`end of the guiding catheter 6 was placed at a position
`that was assumed to be engaged with an entrance of
`the coronaryartery. Then, the guide wire 7... .was
`mserted m the tubular body3 of the above-described
`catheter 1, After that, the catheter | was inserted in
`the guiding catheter together with the guide wire 7.”
`(Exh. 1009, [0092]-[0093)).
`
`| an elongate structure
`_ having an overall length
`_ that is longer than the
`_ predefined lengthofthe
`_ continuous lumen of the
`
`| guide catheter,
`
`
`
`Mihara discloses that the combined length of the wire
`2 and tubular body3 is longer than the guide catheter
`lumen. (See Fig. 3 below}. As shown in Fig. 3,
`catheter is longer that the continuous lumen ofthe
`guide catheter 6 as the wire 2 extends beyond the
`proximal end of the catheter and tubular body 3
`extends beyondthe distal end of the guide catheter6.
`
`Annotated Fig. 2 of Mihara (below) discloses an
`elongate structure | mchading a flexible tip portion
`defining a tubular body 3 wherein the distal-most tip
`portion of the tubular structure does not include
`reinforcing members 34. Instead, the material of
`which the distal-most tip 32 is comprised is flexible,
`being “preferably formed of a flourme resin such as
`polytetrafluoroethylene (PTFE).” (Exh. 1009,
`[O0051}). The outer layer 33 is further described as
`bemg preferably “composed of various kinds of
`thermoplastic clastomers such as a polyurethane
`elastomer, a polyester elastomer, and a polyamide
`elastomer, or a mixture thereof.” (/d., [0052)).
`
`
`the elongate structure
`| including: aflexible tip
`portion defining a tubular
`| structure havinga circular
`‘ross-section that is smaller
`
` than the circular cross-
`| section of the continuous
`lumenof the guide catheter
`| and a length that is shorter
`_ than the predefined length
`_ of the continuous lumen of
`| the guide catheter,
`
`Page 383
`
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`
`Page 383
`
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`
`

`

`
`
`_ The ‘880 Patent
`
`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`
`Mihara (Exh. 1009)
`
`[2] The tubular stracture defined by the flexible tip is
`disclosed as having a circular cross section:
`“Although the mner diameter ofthe tubular body3,
`in other words, the diameter of the hollowportion 31,
`is not particularly limited, the inner diameteris
`preferably 0.4 to 0.8 mm, and more preferably 0.45 to
`0.65 mm.” (Exh. 1009, [0056]).
`
`[3] “Although the length of the tubular body 3 ... is
`not particularly limited, the length is preferably im the
`range of 100 to 400 mm, and more preferably 200-
`300 mm.” (Exh. 1009, [0057)).
`
`
`the flexible tip portion
`| being sized having a cross-
`| sectional outer diameter
`_ sized to be insertable
`_ through the cross-sectional
`_ inner diameter of the
`"continuous lumen of the
`| guide catheter and defining
`_a coaxial lumen having a
`|" cross-sectional inner
`|_ diameter through which
`interventional cardiology
`_ devices are insertable:
`
`[f{ Mihara discloses that the outer diameter ofthe
`tubular body (0.8 mm)is smaller than and sized for
`msertion through the guide catheter lumen (1.8 mm):
`“Onter diameter of a portion between 0 and 90 mm
`from the proximal end side of the tubular body3:
`0.87 mm.” (Exh. 1009, [0081]). “First, the guiding
`catheter 6... having an inner diameter of 1.8 mm...”
`(Exh. 1609, (60927).
`
`[2] As shown in annotated Fig. 3 below, Mihara
`discloses that the flexible tube (tubular body 3”)is
`placed coaxiallyrelative to the guide catheter 6:
`
`Page 384
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`
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`
`

`

`
`
`_ The ‘880 Patent
`
`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`
`Mihara (Exh. 1009) [3] “As shown in Figs. | and 2, the catheter|
` As shown in annotated Fig.
`
`includes a linear wire 2, a tabular body 3 placed on a
`distal end side of the wire 2 and allowing a guide
`wire (not shown) to be inserted in (to penetrate) its
`hollowportion Gumen) 31, and an operation portion
`(holding portion) 4 placed on a proximal end ofthe
`wire 2” (Exh, 1009, [0033}). “The tubular body 3 is
`provided on the distal end side of the wire 2. The
`hollow portion 31 of the tubular body 3 is openedto
`the distal end and the proximal end ofthe tubular
`body3, whereby a guide wire can be inserted
`(penetrate) in the hollowportion 31." (Exh. 1009,
`(00497).
`_a reinforced portion
`1 below: “The tubular
`_ proximalto the flexible tip
`body3 has an mner layer 32 positioned on an inner
`portion; and
`circumferential side, an outer layer 33 formed onan
`outer circumferential side ofthe mner layer 32, and a
`reinforcing body(reinforcing member) 34 placed
`between the inner layer 32 and the outer layer 33.”
`(Exh. 1009, (0050). “In this embodiment, the
`reinforcing body 34 is a spiral coil composed of
`tungsten. The reinforcing body 34 is placed in such a
`manner that the reinforcing body 34 is buriedim the
`
`Page 385
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`
`

`

`
`| ‘The “880 Patent
`Claim Chart A-[: Cls. 1, 2, 3, 4, 12. 14 in viewof
`Mihara Uixh. 1009)
`outer layer 33 (or the immer layer 32). The reinforcing
`body 34 is not limited to a spiral coil, and may be a
`braided body (net-shaped body}, a bar-shaped body,
`or the like.” Gd., 0053); [ts material is not limited to
`tungsten. The reinforcing body 34 may be made of
`stamless steel or the like. “the reinforcing body 34
`composed of a spiral coil at several portions.” Ud.,
`
`[0059%).
`
`| a substantially rigid portion|Mihara discloses a substantially rigid portion 2
`_ proximal of and connected|proximal of and operably connected to, and more
`to, and more rigid alonga_|rigid along a longitudinal axis than the tubular body
`longitudinal axis than, the|comprising a flexible tip portion and defining a rail
`_ flexible tip portion and
`structure without a lumen: “As shown in FIG. 2, in
`| defining a rail structure
`the catheter |, the hollow portion 31, functioning as a
`without a lumen
`guide wire lumen through which a guide wire is
`inserted, is formed merely m a portion ofthe tubular
`body 3 positioned on a distal end side, and ina
`portion of the wire 2 positioned on a proximal end
`side with respect to the portion of the tubular body3,
`no guide wire Jumen is formed.” (Exh. 1009, [0036)).
`“The portion of the wire 2 is solid, so that the wire 2
`has relatively high flexural rigidity and torsional
`rigidity. Therefore, the push-in force applied by an
`operator from the proximal endside of the catheter 1
`_ceaat itransmittedtothedistalendportionofthecatheter|
`
`Page 386
`
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`
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`
`

`

`
`| ‘The “880 Patent
`Claim Chart A-[: Cls. 1, 2, 3, 4, 12. 14 in viewof
`Mihara Uixh. 1009)
`i (tubular body 3) exactly by the wire 2.” (Exh. 1009,
`(0037).
`Mihara describes preferred embodiments where the
`_and having a maximal
`| cross-sectional dimension|diameter of the proximal end push wire 2 is smaller
`| at a proximal portion that is|than the diameter of the tubular body 3 comprising
`_ smaller than the cross-
`the flexible tip: “The outer diameter of the wire 2 in
`_ sectional outer diameter of|the proximal portion ... is preferably 0.5 to 1.5 mm,
`_ the flexible tip portion,
`and more preferably 0.8 to 1.1 mm.” CExh. 1009,
`[G0043}). “PThe outer diameter of the tubular body3
`in a fixed portion withthe wire 2 is preferably 0.8 to
`1.5 mm and more preferably 1.0 to 1.3 mm.” (Exh.
`1009, (0055).
`| such that whenat least a
`As shownin annotated Fig. 3 below, Mihara
`_ distal portion ofthe
`discloses that when at least a distal portion of the
`| flexible tip portion is
`tubular body3 is extended distally ofthe distal endof
`| extended distally of the
`the gunde catheter 6 with at least proximal portion of
`' distal end ofthe guide
`the rigid push wire 2 remaining within the continuous
`catheter with at least
`lumenof the guide catheter, at least a portion ofthe
`| proximal portion of the
`proximal portion of the substantially rigid portion
`_reinforced portion
`extends proximally in common with a guide wire 7
`| remaining within the
`that is msertable into the guide catheter. (Exh. 1009,
`"continuous lumenofthe
`Fig. 3).
`_ guide catheter, at leasta
`| portion of the proximal
`_ portionof the substantially
`_tigid portion extends
`_ proximally throughthe
`_ hemostatic valve in
`| common with
`"interventional cardiology
`| devices that are insertable
`
`| into the guide catheter. Neeneeeeeeeneee beeneeEEEE
`
`Page 387
`
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`
`Page 387
`
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`
`

`

`
`| The ‘880 Patent
`Claim Chart A-[: Cls. 1, 2, 3, 4, 12. 14 in viewof
`Mihara (exh. 1009)
`above).
`“The tubular body 3 and the wire 2 are coupled
`_ wherein the substantially
`(fixed) under a condition that the distal end portion of
`| Tigid portion further
`the wire 2 and the proximal end portion ofthe tubular
`_ includes apartially
`_ cylindrical portion defing|body 3 partially overlap with each other ina
`|anopening extending fora|longitudinal direction. With this configuration, the
`| distance along a side
`wire 2 and the tubular body 3 overlap with each other
`_ thereof defined transverse
`in the coupled portion (fixed portion}. Therefore high
`toa longitudinal axis
`coupling strength can be obtained, andthe
`enlargement ofthe distal end portion ofthe catheter |
`can be prevented.” (Exh. 1009, [O0061]).
`
`from a side transverse to the longitudinal axis:
`
`“Although a method for tixing the wire 2 and the
`tubular body3 is not particularly limited, they are
`fixed by covering the outside (outer circumference)
`of the overlapped portion between the wire 2 and the
`tubular body 3 with a reinforcing tube (coupling
`metber) 5... . [t]he overlapped portion betweenthe
`wire 2 and the tubular body 3 is covered with the
`reinforcing tube 5, and thereafter, they are fused,
`whereby the wire 2 and the tubular body 3 can be
`fixed more strongly m an easy process.” (Exh. 1009,
`[0062)).
`
`Annotated Fig. 2 (below) depicts that the proximal
`side opening (that includes a partially cylindrical
`portion) to the hollowdevice lumen 31 ofthe
`reinforcing tube 5 surrounding the overlapped portion
`of the wire 2 and tubular body3 1s skived or cut at an
`angle,forming an opening that extends for a distance
`along the longitudinal axis and whichis accessible
`
`50
`
`Page 388
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`
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`

`

`
`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`_ The ‘880 Patent
`
`Mihara (Exh. 1009)
`[O049)).
`
`
`
`“the wire 2 is provided with appropriate rigidity
`(flexural rigidity and torsional rigidity), which
`enhances a push-in property and transmittance ofa
`torque.” (Exh. 1009, [0043]).
`“The hollowportion 31 ofthe tubular body3 is
`opened to the distal end and the proximal end of the
`tubular body 3, whereby a guide wire can be mserted
`(penetrate) in the hollowportion 31.” CExh. 1009,
`
`Annotated Fig. 2 (below) of Mihara discloses a
`proximal opening extending substantially along at
`least a portion of a length of the substantiallyrigid
`portion.
`
`that is adapted to receive
`an interventional
`cardiology device passed
`through continuous lumen
`of the guide catheter and
`mito the coaxial lumen
`while the device is
`mserted mito the
`continuous lumen,
`the opening extending
`substantially along at least
`a portion of a length ofthe
`substantiallyrigid portion.
`
`Page 389
`
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`
`Page 389
`
`Medtronic Exhibit 1803
`
`

`

`
`
`_ The ‘880 Patent
`
`Claim Chart A-1: Cis. 1,2, 3, 4, 12. 14 in viewof
`Mihara (Exh. 1009)
`
`
`
`FPIG.2
`
`B.
`
`Claims 1-4, 8, 12, 14 And 17 Are Obvious Under 35 U.S.C. § 103 Over
`Pub. No. U.S. 2007/0260219
`
`As discussed above, all challenged claims of the ‘850 patent are, at best,
`
`onlyentitled to an effective filing date of January 26 2012, whichis the filme date
`
`of the “S850 patent. The publication of US. Patent Application 11/416,629 Che
`
`application of the‘O32 patent}, Pub. No. U.S. 2007/0260219 CExh. 1012}, was
`
`publicly available more than one year before the filing date of the “850 patent and
`
`thus constitutes prior art under $102(b). While the disclosure set forth in Pub. No.
`
`U.S. 2007/0200219 has imsufficient written description to support a claim of
`
`priority for the reasons discussed above, it would have been obvious to replace a
`
`‘monorail’ tube-—which has a lumen with the stiffening clement or advancement
`
`member of a “rail without a lumen” because stiif proximal low profile structures
`
`Page 390
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`

`

`for pushing the tubular structure of a rapid exchange catheter through to the
`
`treatment site were known to be necessary for the delivery of monorail rapid
`
`exchange devices. (Exh. 1003 © 53-54).
`
`Cc,
`
`Claims 1-4, 12, and 14 Are Obvious Under 385 U.S.C. § 103 Over
`Mihara In View of the Knowledge of a Person of Ordinary Skill in the
`Art
`
`To the extent that the Board conchides that the order and intended use
`
`limitations of claims 1, 2,3, 4, 12, and 14 are not expressly or inherently disclosed
`
`by Mihara, Petitioner asserts that those characteristics should be deemed obvious
`
`based on Mihara alone. All of the structural recitations of the claims are expressly
`
`disclosed by Mihara as discussed above, and therefore, Petitioner references the
`
`analysis and claim charts for those elements as part of its obviousness analysis
`
`here. See Intellectual Ventures Memt., LLCv. Xilinx, 1PR2012-00020, 9 (Feb. 11,
`
`2014) (A reference need not teach every feature for it
`
`to render a claimed
`
`invention obvious....[A]n obviousness determination takes into account what a
`
`person of ordinary skill mthe art would have knownat the tome of the invention
`
`and is not limited to what is contained within the four corners of a parent or printed
`
`publication.”); see Leapfrog Eaters.
`
`Inc. v. Fisher-Price,
`
`inc., 485 F.3d L137,
`
`1162 (Fed. Cir. 2007).
`
`D.
`
`Claims 1-4, &12, 14 and 18 Are Obvious Under 35 U.S.C. § 103)
`Over Mihara in View Of Takahashi
`
`Page 391
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`

`

`As shown below, each element recited in claims 1-4, 8, 12, 14 and 18 is
`
`obvious over Mihara in view of Takahashi. Although Takahashi was cited during
`
`prosecution of the ‘032 Patent,
`
`it was not discussed in any Office Action or
`
`considered i combimation with Mihara.
`
`Mihara, such limitations could be found by one of ordmary skill in one or
`
`more of the other references and would have beenin the possession of or obvious
`
`to one of ordinary skill in the art from the disclosures of analogousart, particularly
`
`Mihara and Takahashi. (1003, 936).
`
`Claims 8 and 18 require that “the cross-sectional mmner diameter of the
`
`coaxial lumen of the tubular structure is not more than one French smaller than the
`
`cross-sectional
`
`immer diameter of the guide catheter.” Takahashi satisfies the
`
`limitations of claims 8 and 18 in that it discloses a method of inserting a 5 French
`
`guiding catheter mnto a 6 French guiding catheter such that the cross-sectional inner
`
`diameter of the 5 French catheter is not more than one French smaller than the
`
`cross-sectional
`
`inner diameter of the 6 French catheter. A POSA would have
`
`understood the advantages of havmg minimal difference in diameter between the
`
`outer diameter of the inner guide catheter and the inner diameter of the outer guide
`
`catheter, and would recognize that this teaching of Takahashi’s 5-in-6 system
`
`could be applied to any coaxial catheter directed to imsertion through a standard
`
`guide catheter for purposes of providing backup support during interventional
`
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`cardiology procedures, such as Mihara, and would have been motivated to do so.
`
`(Ex. 1003 €] 92-04),
`
`In 2004,
`
`the same year in which the Mihara publication was filed and
`
`published on behalf of assignee Terumo (and within which the Terumo Heartrail is
`
`expressly discussed as being used during testing of the Mihara support catheter),
`
`the Takahashi article disclosed use of Terumo’s Heartrail guide catheter in
`
`teaching the advantages of minimizing differences in diameter for purposes of
`
`achieving the fimctionality of both a support catheter (enhanced pushability and
`
`backup support) and a guide catheter Qvorking channel betweenthe site of vascular
`
`access and the target vessel).
`
`A POSA reviewing the device disclosed by Mihara at
`
`the time of the
`
`claimed invention would, therefore, have been motivated by Takahashi to achieve
`
`the advantages of having minimal difference in diameter by practicing the
`
`invention of Mihara withm the claimed range of not more than one French with the
`
`predictable and expected results of allowing for the insertion of larger devices
`
`through the creation of a larger working channel. (See Exh. 1003 [64-65 and 86-
`
`97,
`
` The “850 Patent
`
`Claim Chart A-2: Cl. 8, 18
`Mihara Gixh, 1009) in view of Takahashi (ixh.
`|
`
`1021)
`|
`Miharadiscloses the system of claim | (See A-I,
`&. The system of claim1,
`
`above). :
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`|
`
`wherein the cross-sectional
`toner diameter of the coaxial
`lumen of the tubular structure
`is not more than one French
`smaller than the cross-
`sectional mer diameter of
`the guide catheter.
`
`
`
`Claim Chart A-2: CL 8, 18
`Mihara Coxh. 1009) in viewof Takahashi (ixh.
`The ‘850 Patent
`1021)
`“The five-in-six system is a method of inserting a
`5 Fr guiding catheter (Heartrail, Terumo, Japan)
`imto a 6 Fr guiding catheter to mcrease backup
`support. As we insert the 5 Fr inner guiding
`catheter into the target artery through the outer 6
`Fr guiding catheter, stronger backup support can
`be generated (Fig. [A)}.” (Exh. 1021 at 452).
`“The mner himen ofthe 5 Fr Heartrail catheter is
`0.059’ in diameter.... The inner lumen of the outer
`6 Fr catheter needs to be more than 0.0717 in
`diameter to accommodate the 5 Fr Heartrail
`catheter...” Ud). “In the five-in-six system, the
`backup support was measured while protruding the
`5 Fr catheter mto the artery model out ofthe outer
`6 Fr. catheter...” Gd. at 453) “Only mserting the 5
`Fr guiding catheter into the 6 Fr catheter increased
`backup support....” Gd}. “A 5 Fr guiding catheter
`is inserted along the PCI guidewire to the 6 Fr
`guiding catheter.” Cd. at 454).
`Mihara discloses the device of claim 11. (See
`above).
`See Takahashi disclosures set forth in claim 8. (See |
`above).
`
`18 The system of claim 12
`
`wherein the cross-sectional
`inner diameterof the coaxial
`lumen of the flexible distal
`portion is not more than one
`French smaller than the cross-
`sectional imner diameter of the
`guide catheter.
`
`IX. CONCLUSION
`
`Based on the foregoing, it is clear that claims 1-4, 12, and 14 of the ‘850
`
`Patent define subject matter that is anticipated by Mihara and that claims 1-4, 8,
`
`12, 14, and 18 of the ‘850 patent define subject matter that is obvious in viewof
`
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`Mihara combimed with the teachings of Takahashi. Mihara and the prior art
`
`combination cited above were never considered by the Examiner; if they had been,
`
`such claims would not have issued. In light of the evidence set forth herein, which
`
`establishes a reasonable likelihood that Petitioner will prevail on at least one claim
`
`of the “850 patent, Petitioner requests institution of an infer purtes reviewto cancel
`
`those claims.
`
`Respectfully submitted,
`
`ARNOLD & PORTER LLP
`
`{David R. Marsh/
`
`David R. Marsh (Atty. Reg. No. 41,408)
`ARNOLD & PORTERLLP
`555 12" Street, NW.
`Washington, D.C. 20004
`Tel: (202) 942-5068
`Fax: (202) 942-8999
`
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`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the PETITION FOR INTER
`
`PARTES REVIEW UNDER 37 CER. § 42.100 with Exinbits was served by
`
`depositing the same with Quick International Courier on May 16, 2014,
`
`to the
`
`USPTOcorrespondence address of recordlisted below:
`
`Patterson, Thuente, Petersen, PA
`4800 [DS Center
`80 South 8" Street
`Minneapolis, MN 35402-2100
`
`Courtesy copies were also shipped to counsel for patent owner at
`
`the
`
`following address:
`
`J. Thomas Vitt
`Heather Redmond
`Shannon Bjorklund
`Forrest Tahdooahnippah
`Dorsey &Whitney
`50 South Sixth Street
`Suite 1500
`Minneapolis, MN 55402
`Telephone: (612) 340-2600
`
`[DavidR.Marsh/
`
`David R. Marsh (Atty. Reg. No. 41,408}
`ARNOLD &PORTER LLP
`555 12” Street, N.W.
`Washington, D.C. 20004
`Tel: (202) 942-5068
`Fax: (202) 942-5999
`
`Page 396
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`ATTACHMENT C
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`Page 397
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BOSTON SCIENTIFIC CORPORATIONand
`BOSTON SCTENTTFIC SCIMED, INC.
`Petitioner
`
`VASCULAR SOLUTIONS, TNC,
`Patent Owner
`
`Case JPR: Unassioned
`Patent $,142,413 B2
`
`Attorney Docket No. 0025216-00057
`
`PETITION FOR INTER PARTES REVIEW
`UNDER 37 CLELR. § 42.108
`
`Page 398
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`TABLE OF CONTENTS
`
`Page
`
`MANDATORYNOTICES (37 CER. 8 42.8(QUEDcece
`A.
`Real Party-In-Interest (37 C.F.R. § 42. SCD) oo ccccsceesceeeeerens 5
`B.
`Related Matters (37 CFR. 8 AZ. 8(D)OQ)) ccc ects cecettecetecnerenees 5
`C.
`Lead And Back-Up Counsel (37 C.F.R. §§ 42.8(0)(3), 42.10(a)}........ 6
`D.
`Service Information G7 C.F_R. § 42. 8(B4S) oc cccneceeeeeeteeees §
`
`PAYMENTOF FEES (37 CER. 9 42103) oc ccececsesccetsecnsseeenesesacens &
`
`SUMMARYOF RELEVANT TECHNOLOGYAND ‘413 PATENT......... 6
`A.
`Overview Of Interventional Cardiology Procedures oo... cece csesneees 7
`B.
`Description OF The Alleged Invention Of The “413 Patent... 8
`C.
`Summary of the Prosecution History of the ‘413 Patent... 10
`
`1.
`
`I.
`
`HL
`
`TV.
`
`C.
`D.
`
`E.
`
`REQUIREMENTSFOR INTER PARTES REVIEW.....ccccsscessccesseecsseees 12
`A.
`Grounds for Standmg Under 37 C.PLR. § 42. 104€a) eee 12
`B.
`Identification of Challenge Under 37 CPLR. § 42.104(b) and Relief
`ReQUESECT ooo... cc cccececetseccnsecnasceetsnecnssecaaseceasceensusansuccasscausseestaceneees 12
`Claims for Which inter Partes Review Is Requested... 12
`The Specific Art and Statutory Ground(s}) on Which the Challenge
`Is Based Under 37 C.ELR. § 42. 1O40B2) ccc cecssseneeeeeeteeeenees 12
`Construction Of The Challenged Claus oo... eececscsssecsssecsseenssetteenaee {3
`L.
`“ral structure without a Hamer?occ ccc ceeeceeeeteeeteees 14
`2.
`“mterventional cardiology device(Sy” oo... ecceccstscctseeees 16
`The Prior Art References... ..ccccssccssssccsssccssecssreseassneesnaseessaesuaeeneveecsaeces 16
`L. Aas 292 occ cece cecceess tens cneeeeneeesaneessecensntanenecsescenaesaeatatess 17
`2.
`KVCE cece ccsseeeeseccaseceeesscaaesaeessecaeneaessecansacausecaaeeseussceuetecnaey {8
`3,
`AG aris “452 oo occcccceccesecccsseceeceetsocsusecessecusrecsesseesssecesscaesnecetuaees 18
`A. Mn ata occ ccccceseccesecseennececoeesssecsesseeessasevseceasecatsneeeenecesasecsaeceeees 19
`5.
`SECUIKC cc ccccessesecsncensnteessecesetesvsaesaecnevessesusanevatsacecevsaneenscaasatens {9
`6.
`Takcahashyy oo...cccecccccccccccscecstenecesecccnsecsasccsnsensanaecnasscaresenenreceneees 20
`HowThe Construed Claim(s} Are Unpatentable oo... ccneeeees20
`Supporting Evidence Under 37 C.FLR. § 42. 104( DKS) eee 21
`
`PF.
`
`G.
`H.
`
`VV.
`
`DETAILED EXPLANATION OF PERTINENCE AND MANNER OF
`APPLYING CITED PRIOR ART TO EVERYCLAIM FOR WHICH
`REVIEWIS REQUESTED UNDER 37 CPLR. 8 42. 104(bW4)oo. 2k
`A.
`Claims | And 13 Are Anticipated Under 35 ULS.C. $102(b} By
`AGAMS 292 oo cecccacecersecetsoceereceasseeeseceesaeceavsecsaniccazeceensceasaocarsaecazeceazeees Zi
`L.
`CUALoe cccececcessecetenecnscceeeneceascecevseceasecervescasseersaecerseeeevaeeness 22
`
`i
`
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`

`B.
`
`C.
`
`D.
`
`E.
`
`F,
`
`G.
`
`H.
`
`1.
`
`CHAILB ieee ceeeceeeeeeseeneeeeeeseeeaeeeeeseecaeeeeesiuecaseceetaveeseseesiecaees 24
`2.
`Statement Of Non-Redundancy: Skived Proximal Opening
`Disclosures m Klein,Adams *452, Mihara, And Stemke3]
`Claims 1, 4, 9, And 10 Are Obvious Under 35 U.S.C. $8103 Over
`Adams *292 In View Of The Knowledge Of One OF Ordinary Shall
`Tin The Art ooo. .cccccsssccsnsecsrsceasesensecessccsasceascceassecuseceuiecensecsssesasessed
`Claims 1, 4,9, 10 And 13 Are Obvious Under 35 U.S.C. $103 Over
`Adams °292 In View OF Rieti ccc ccccccecenracersseerssncertneserstereeag
`Claims 1, 4,9, 10 And 13 Are Obvious Under 35 U.S.C. $103 Over
`Adams °292 In View OF Adams ‘432 ooo ccccccccccccsessecceesseecesssreeeees AQ
`Claims 1, 4, 9, 10 and 13 Are Obvious Under 35 U.S.C, §163 Over
`Adams °292 In View OF Mihara oo. ccccccccccccceesecsessesesseseesaeceeaseseanes 45
`Claims |, 4, 9, 10 and 13 Are Obvious Under 35 U.S.C. $103 Over
`Adams °292 In View OF Steinke oo... .ccccccsssccsescecsreccursecstsecesreeessseetnel
` Claim13 ts Obvious Under 35 U.S.C. $103 Over Adams °292 In
`View Of The Knowledge Of One Of Ordinary Skill In The Art... 35
`Claims | And 13 Are Obvious Under 35 U.S.C. $103 Over Adams
`‘292 In View OF Takahashi ooo. eccccecccececceeseeceseesuesesusecerseesenenuees 57
`
`VL
`
`CONCLUSION oo. ccccccecccseccsseceasccaseneeesececasessescsenssneatsecansearsoeesvseessssecaseenaees 59
`
`2
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`
`
`Exhibit List for fater Partes Review of U.S. Patent No. $,142.413
`
`
`
`
`Pa ent No. 8.