UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-00072
`Patent 6,915,560
`_______________
`
`CORRECTED
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`PATENT OWNER’S LIST OF EXHIBITS ............................................................iv
`
`IV.
`
`V.
`
`STATEMENT OF RELIEF REQUESTED ....................................................1
`I.
`INTRODUCTION ...........................................................................................1
`II.
`III. BACKGROUND .............................................................................................2
`A.
`Prior Art Crimping Methods And Devices ...........................................3
`B.
`The ’560 Patent .....................................................................................5
`THE ART AND GROUNDS OF UNPATENTABILITY RELIED
`ON BY PETITIONER.....................................................................................6
`THE PETITION SHOULD BE DENIED BECAUSE THE
`ALLEGED AAPA DOES NOT CONSTITUTE A PRIOR ART
`PATENT OR PRINTED PUBLICATION......................................................7
`EVEN IF THE ALLEGED AAPA COULD BE CONSIDERED,
`THE PETITION SHOULD STILL BE DENIED BECAUSE THE
`SAME OR SUBSTANTIALLY THE SAME ART AND
`ARGUMENTS WERE PREVIOUSLY PRESENTED TO THE
`OFFICE..........................................................................................................12
`A.
`The Examiner Repeatedly Considered The Alleged AAPA...............13
`B.
`The Examiner Also Considered Morales ............................................17
`C.
`The Examiner Also Previously Considered Prior Art
`Substantially The Same As Sabbaghian and Baker ............................17
`VII. PETITIONER HAS FAILED TO CARRY ITS BURDEN OF
`DEMONSTRATING A REASONABLE LIKELIHOOD OF
`OBVIOUSNESS IN ANY EVENT...............................................................21
`A.
`Claim Construction..............................................................................22
`1.
`“A Stent Crimper Comprising”.................................................23
`2.
`“Stationary End-Walls” And “Stationary Plates”.....................25
`The Combination Of References Does Not Disclose Every
`Limitation Of Claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28,
`31, 33-35, 37, and 40...........................................................................27
`
`VI.
`
`B.
`
`-i-
`
`

`

`C.
`
`2.
`
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References Or A Reasonable
`Expectation Of Success In Combining References.............................30
`1.
`GROUND 1: The Alleged AAPA In View Of
`Sabbaghian................................................................................31
`a.
`Lack Of Motivation To Combine...................................31
`b.
`No Reasonable Expectation Of Success.........................39
`GROUND 2: The Alleged AAPA In View Of
`Sabbaghian And Morales..........................................................41
`GROUND 3: The Alleged AAPA In View Of Baker...............42
`GROUND 4: The Alleged AAPA In View Of Baker And
`Morales......................................................................................44
`VIII. PETITIONER’S CITATION OF ADDITIONAL REFERENCES
`DOES NOT SUPPORT A REASONABLE LIKELIHOOD OF
`OBVIOUSNESS............................................................................................44
`IX. CONCLUSION..............................................................................................45
`
`3.
`4.
`
`-ii-
`
`

`

`TABLE OF AUTHORITIES
`
`CASES
`Bell Commc’ns Research, Inc. v. Vitalink Comm’ns Corp.,
`55 F.3d 615 (Fed. Cir. 1995) ..............................................................................24
`
`Page(s)
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) ..........................................................................38
`
`Catalina Mktg. Int’l v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) ............................................................................24
`
`Ex Parte Ji-Young Lee,
`Appeal No. 2006-2328, 2006 WL 4075454 at *19-20 (B.P.A.I.
`Feb. 23, 2007) .......................................................................................................9
`
`In re Cortright,
`165 F.3d 1353 (Fed. Cir. 1999) ..........................................................................26
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................31
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007).....................................................................................passim
`
`Leo Pharm. Prods. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ..........................................................................43
`
`Poly-America, L.P. v. GSE Lining Tech., Inc.,
`383 F.3d 1303 (Fed. Cir. 2004) ..........................................................................23
`
`Rexnord Corp. v. Laitram Corp.,
`274 F.3d 1336 (Fed. Cir. 2001) ..........................................................................25
`
`Rotatable Techs. LLC v. Motorola Mobility LLC,
`567 F. App’x. 941 (Fed. Cir. 2014) ....................................................................24
`
`In re Suitco Surface, Inc.,
`603 F.3d 1255 (Fed. Cir. 2010) ..........................................................................26
`
`-iii-
`
`

`

`DOCKETED CASES
`Cannon Inc. v. Papst Licensing GMBH & Co.,
`Case No. IPR2016-01206 .............................................................................16, 21
`
`Costco Wholesale Corp., v. Robert Bosch,
`Case No. IPR2016-00035 ...................................................................................31
`
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`Case No. IPR2012-00001 ...................................................................................27
`
`Intri-Plex Tech., Inc. v. Saint-Gobain Performance Plastics Rencol
`Ltd.,
`Case No. IPR2014-00309 .............................................................................11, 12
`
`Knightbright Elec. Co. LTD v. Cree, Inc.,
`Case No. IPR2015-00744 ...................................................................................45
`
`Knightbright Elec. Co. LTD v. Cree, Inc.,
`Case No. IPR2015-00746 .............................................................................10, 11
`
`Microsoft Corp. v. Secure Web Conference Corp.,
`Case No. IPR2014-00745 ...................................................................................37
`
`Nu Mark LLC v. Fontem Holdings 1, B.V.,
`Case No. IPR2016-01309 ...................................................................................21
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`Case No. IPR2016-00165 ...................................................................................38
`
`Seabery N. Am., Inc. v. Lincoln Glob., Inc.,
`Case No. IPR2016-00749 ...................................................................................31
`
`Unified Patents Inc., v. John L. Berman,
`Case No. IPR2016-01571 .............................................................................16, 21
`
`STATUTES, RULES AND REGULATIONS
`
`37 C.F.R. § 42.104(b)(4)..............................................................................7, 8, 9, 42
`
`37 C.F.R. § 42.107(a).................................................................................................1
`
`37 C.F.R. § 42.108(b) ..............................................................................................13
`
`-iv-
`
`

`

`35 U.S.C. § 103........................................................................................................27
`
`35 U.S.C. § 103(a) ...............................................................................................7, 41
`
`35 U.S.C. § 103(c) ...............................................................................................9, 12
`
`35 U.S.C. § 311(b) .......................................................................................7, 8, 9, 33
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`OTHER AUTHORITIES
`
`MPEP 706.02(L)(2) ...................................................................................................9
`
`MPEP § 2129 .............................................................................................................9
`
`-v-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`
`PATENT OWNER’S LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`Handbook of Coronary Stents, 2000 Ed.
`
`U.S. Patent No. 5,437,083
`
`U.S. Patent No. 5,626,604
`
`U.S. Patent No. 5,725,519
`
`U.S. Patent No. 5,746,764
`
`U.S. Patent No. 5,810,873
`
`U.S. Patent No. 6,051,002
`
`U.S. Patent No. 5,951,540
`
`U.S. Patent No. 6,364,870
`
`File History Of U.S. Patent No. 6,360,577
`
`Boston Scientific’s Interrogatory Responses served on August 4,
`2016
`
`September 30, 2016 Letter From Wallace Wu to Brian Horne
`
`U.S. Patent No. 6,360,577
`
`U.S. Patent No. 6,823,576
`
`-vi-
`
`

`

`I.
`
`STATEMENT OF RELIEF REQUESTED
`
`On October 14, 2016, Edwards Lifesciences Corporation (“Petitioner”)
`
`submitted a Petition for Inter Partes Review (the “Petition” or “Pet.”) challenging
`
`claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28, 31, 33-35, 37, 39, and 40 of U.S.
`
`Patent No. 6,915,560 (“the ’560 Patent”). Pursuant to 37 C.F.R. § 42.107(a),
`
`Boston Scientific Scimed, Inc. (“Patent Owner”) submits this Preliminary
`
`Response requesting that the Board deny the Petition because Petitioner has not
`
`demonstrated a reasonable likelihood of unpatentability of any challenged claim.
`
`II.
`
`INTRODUCTION
`
`Petitioner relies on four grounds of obviousness arguments. The primary
`
`reference in each ground relates to what is referred to as the Applicant’s Admitted
`
`Prior Art (AAPA). Petitioner, however, presents no evidence demonstrating that
`
`the alleged AAPA was publicly available prior to the critical date of the invention.
`
`Nor does Petitioner demonstrate that the alleged AAPA constitutes a patent or a
`
`printed publication, the only statutory categories of prior art on which the Board
`
`may institute an inter partes review. Indeed, the alleged AAPA relates to Patent
`
`Owner’s own work, which was never commercialized. Because Petitioner has not
`
`established that the alleged AAPA constitutes a prior art patent or printed
`
`publication, the Petition fails to comply with the statutory requirement.
`
`-1-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`Even assuming that the alleged AAPA could be considered by the Board, all
`
`of the references relied on by Petitioner are the same or substantially the same as
`
`those previously presented to the Office during the prosecution of the ’560 Patent.
`
`Accordingly, the Board should exercise its discretion to deny the Petition under 35
`
`U.S.C. § 325(d).
`
`But even if the Board is not inclined to exercise this discretion, it should still
`
`deny the Petition because Petitioner has failed to carry its burden of demonstrating
`
`that: (1) the combination of references discloses every limitation of the claimed
`
`invention; (2) there would have been sufficient motivation to combine the
`
`references at issue; and (3) there would have been a reasonable expectation of
`
`success if the references were combined.
`
`III. BACKGROUND
`
`Patent Owner has been a pioneer in stent technologies since the 1980s. A
`
`stent is a tiny tube made of metal or alloy that is placed in an artery (or other body
`
`lumens) to keep the artery open, improve blood flow, and prevent the artery from
`
`collapsing. In the 1990s, Patent Owner (including its predecessor, Scimed Life
`
`Systems, Inc.) introduced a series of innovative stent products, such as the NIR
`
`stent and the NIROYAL stent. (Ex. 2001 at 281-293.)
`
`Claiming priority to a September 22, 1999 patent application, the ’560
`
`Patent relates to an apparatus for reducing the diameter of a stent so that it could be
`
`-2-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`crimped onto a delivery catheter. The delivery catheter typically includes a
`
`balloon over which the stent would be crimped. The crimped stent and balloon at
`
`the end of the catheter are passed through the patient’s body to the treatment site,
`
`where the crimped stent is then expanded with the balloon to the diameter of the
`
`vessel. The expanded stent acts as a scaffold to maintain an open, unobstructed
`
`vessel. (Ex. 1001 at 1:25-31.)
`
`It was (and still is) critically important to minimize distortion of the stent
`
`during the crimping process and to allow secure retention of the stent on the
`
`balloon catheter. (Id. at 1:38-43.) A poorly crimped stent may slip and be either
`
`lost in the body or deployed in the wrong location. (Id. at 1:44-45.) A poorly
`
`crimped stent can also cause abrasion or trauma to vessel walls and damage the
`
`underlying balloon to which it is attached. (Id. at 1:44-47.)
`
`A.
`
`Prior Art Crimping Methods And Devices
`
`In the years leading up to the 1999 priority date of the ’560 Patent, numerous
`
`attempts were made to uniformly and securely crimp a stent. For example, U.S.
`
`Patent No. 5,437,083, filed in 1993, describes two parallel sliding surfaces that are
`
`moved together to evenly apply crimping forces. (Ex. 2002 at 1:48-52, 2:16-23.)
`
`U.S. Patent No. 5,626,604, filed in 1995, describes a collet with radially
`
`compressible fingers that are driven radially inward to uniformly crimp a stent.
`
`(Ex. 2003 at 2:19-28, 4:44-50.) U.S. Patent No. 5,725,519, filed in 1996, describes
`
`-3-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`a stent within a tube that is pulled through a bore of decreased diameter to
`
`uniformly crimp the stent. (Ex. 2004 at 1:33-44.) U.S. Patent No. 5,746,764, filed
`
`in 1996, describes a fluid compression apparatus to uniformly crimp a stent. (Ex.
`
`2005 at Abstract.) U.S. Patent No. 5,810,873, filed in 1997, describes a stent and a
`
`balloon catheter that are slidably moved through a tapered opening to tightly and
`
`uniformly crimp the stent. (Ex. 2006 at Abstract, 2:12-32.)
`
`U.S. Patent No. 6,051,002, filed in 1998, describes a crimping tool having a
`
`cylindrical loop. (Ex. 2007 at Abstract, 2:22-32.) When handles of the tool are
`
`compressed, ends of the loop are pulled in opposite directions, causing the loop to
`
`crimp a stent uniformly and tightly. (Id.) U.S. Patent No. 5,951,540, filed in 1998,
`
`describes a crimping sleeve with crimping elements formed around a channel.
`
`(Ex. 2008 at Abstract, 1:66-2:19.) A delivery device with a stent can be inserted
`
`into the channel, and the stent is crimped when the sleeve is compressed. (Id.)
`
`U.S. Patent No. 6,364,870, filed in 1998, describes a device in which a first
`
`crimping portion is inserted into a second crimping portion to form a channel.
`
`(Ex. 2009 at Abstract, 1:26-52.) Further insertion of the first portion into the
`
`second portion causes the size of the channel to decrease so that a stent can be
`
`uniformly and securely crimped onto a catheter within the channel. (Id.)
`
`-4-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`
`B.
`
`The ’560 Patent
`
`Improving upon the then existing crimping methods and devices, the ’560
`
`Patent discloses and claims an innovative crimper that includes both coupled and
`
`movable blades forming a variable-sized aperture that applies even forces while
`
`minimizing the distortion of the stent. (Ex. 1001 at 2:26-29, 2:56-65.) An
`
`exemplary crimper design is shown in Figure 4A of the ’560 Patent:
`
`In Figure 4A, the stent crimper comprises eight coupled blades 106 (orange)
`
`disposed about a reference circle 114 (green) to form an aperture 118, in which the
`
`stent is disposed. (Id. at 4:66-5:12.) Each blade 106 includes a radial point 122
`
`-5-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`(yellow), which lies on a radial line 126 (blue) of the reference circle 114. Each
`
`blade 106 may only move in a direction parallel to the radial line 126.
`
`In use, as an actuation plate 142 is rotated in a clockwise direction, the
`
`clockwise motion of the actuation plate is translated into linear motion of each
`
`linear slide 154 and blade 106 via bearing 150. (Id. at 5:46-62.) Each blade 106
`
`moves outward in a direction parallel to the radial line 126, resulting in the opening
`
`of aperture 118. Conversely, as the actuation plate 142 is rotated in a counter-
`
`clockwise direction, each blade 106 moves inward in a direction parallel to the
`
`radial line 126, resulting in the closing of aperture 118.
`
`Claim 1, which is representative of the challenged claims, reads:
`
`1. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris having a longitudinal
`axis, the iris defining an aperture, the dies disposed about the aperture
`and between stationary end-walls which are disposed about the
`longitudinal axis, at least one of the stationary end-walls operatively
`engaged to the dies at distinct connection locations such that the number
`of distinct connection locations and the number of dies are the same;
`each die having a first straight side and a second straight side, the first
`straight side and the second straight side conver[g]ing to form a tip;
`wherein a portion of the first straight side of each die faces the aperture,
`each first straight side parallel to the second side of an adjacent die.
`
`IV. THE ART AND GROUNDS OF UNPATENTABILITY RELIED ON
`BY PETITIONER
`
`Petitioner relies primarily on the alleged AAPA, which includes (1) Figure 1
`
`of the ’560 Patent, (2) the passage at 1:62-2:21 of the ’560 Patent regarding
`
`Figure 1, and (3) the Applicant’s attorney statements in the file history of the ’560
`
`-6-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`Patent regarding Figure 1. (E.g., Pet. at 36, 73 (citing Ex. 1002 at 65); Ex. 1011 at
`
`¶ 152 (citing Ex. 1002 at 65).) Petitioner also relies on U.S. Patent Nos. 5,918,511
`
`(“Sabbaghian”), 4,308,744 (“Baker”), and 5,893,852 (“Morales”). (Pet. at 29.)
`
`Petitioner raises four grounds of unpatentability arguments:
`
`Ground #
`1
`
`2
`
`3
`
`4
`
`V.
`
`Challenged Claims
`1,2, 6, 8-10, 14, 15,
`18, 23, 25, 27, 28, 31,
`33, 37, and 40
`11, 17, 19, 26, 34, 35,
`and 39
`
`1,2, 6, 8-10, 14, 15,
`18, 23, 25, 27, 28, 31,
`33, 37, and 40
`11, 17, 19, 26, 34, 35,
`and 39
`
`Basis
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`References
`AAPA and
`Sabbaghian
`
`AAPA,
`Sabbaghian, and
`Morales
`AAPA and
`Baker
`
`AAPA, Baker,
`and Morales
`
`THE PETITION SHOULD BE DENIED BECAUSE THE ALLEGED
`AAPA DOES NOT CONSTITUTE A PRIOR ART PATENT OR
`PRINTED PUBLICATION
`
`35 U.S.C. § 311(b) provides that “[a] petitioner in an inter partes review may
`
`request to cancel as unpatentable 1 or more claims of a patent only on a ground
`
`that could be raised under section 102 or 103 and only on the basis of prior art
`
`consisting of patents or printed publications” (emphases added). See also
`
`37 C.F.R. § 42.104(b)(4) (The petition “must specify where each element of the
`
`claim is found in the prior art patents or printed publications relied upon….”)
`
`(emphasis added). Each of Petitioner’s four grounds of challenges relies on the
`
`alleged AAPA as a primary reference. Petitioner has not established that any
`
`-7-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`aspect of the alleged AAPA constitutes a prior art patent or printed publication
`
`under 35 U.S.C. § 311(b) or C.F.R. § 42.104(b)(4).
`
`First, while Figure 1 of the ’560 Patent as issued in 2005 is labeled (by
`
`mistake) as “PRIOR ART” (left below), it was not so labeled in the original patent
`
`filing on September 22, 1999 (right below):
`
`Ex. 1001 (as issued)
`
`Ex. 2010 at 37 (as filed)
`
`Figure 1, as filed on September 22, 1999, was not identified as prior art because it
`
`is not.1 Petitioner presents no evidence demonstrating that Figure 1 was publicly
`
`1 During the prosecution of the priority application of the ’560 Patent (Serial No.
`
`09/401,218 filed on September 22, 1999, which matured into U.S. Patent No.
`
`6,360,577), the Examiner, in a February 23, 2000 Office Action, requested,
`
`without explanation, that the Applicant label Figure 1 as “PRIOR ART.”
`
`Footnote continued on next page
`
`-8-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`available prior to the critical date of September 22, 1999. Accordingly, Petitioner
`
`has not carried its burden of establishing that Figure 1 constitutes a prior art patent
`
`or printed publication under 35 U.S.C. § 311(b) or C.F.R. § 42.104(b)(4).
`
`Footnote continued from previous page
`(Ex. 2010 at 61.) In a May 23, 2000 Response, the Applicant’s attorney
`
`mistakenly obliged. (Id. at 81.) The Applicant never cited the alleged AAPA in an
`
`Information Disclosure Statement and the alleged AAPA does not appear on the
`
`face of the ’560 Patent or its parent patents. (Exs. 1001, 2013, 2014.) Even if
`
`Petitioner argues that Figure 1, following the Applicant’s mistaken prior art
`
`labeling, is deemed prior art by admission, commonly owned admitted prior art is
`
`disqualified as prior art under pre-AIA 35 U.S.C. § 103(c) and the doctrine of prior
`
`art by admission does not apply to a patent owner’s own work. See 35 U.S.C.
`
`§ 103(c) (pre-AIA) (excluding subject matter as prior art if it and the claimed
`
`invention “were, at the time the claimed invention was made, owned by the same
`
`person or subject to an obligation of assignment to the same person”);
`
`MPEP 706.02(L)(2); Ex Parte Ji-Young Lee, Appeal No. 2006-2328, 2006
`
`WL 4075454 at *19-20 (B.P.A.I. Feb. 23, 2007); see also MPEP § 2129 (Only
`
`admissions identifying the “work of another” can be relied on for anticipation and
`
`obviousness determinations.).
`
`-9-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`In the pending district court litigation where Patent Owner asserts
`
`infringement of the ’560 Patent against Petitioner, Patent Owner informed
`
`Petitioner—prior to the filing of this Petition—that Figure 1 represents Patent
`
`Owner’s own work (internally referred to as the “STAR crimper”) and that the
`
`STAR crimper was never commercialized. (Ex. 2011 at 23; Ex. 2012 at 3.)
`
`Petitioner does not dispute these facts in its Petition. See, e.g., Knightbright Elec.
`
`Co. LTD v. Cree, Inc., Case No. IPR2015-00746, Paper 8 at 6 (P.T.A.B. August
`
`20, 2015) (denying institution in part because the petition did not provide any
`
`information indicating the product literature at issue was publicly accessible as a
`
`prior art printed publication).
`
`Second, the description of Figure 1 at 1:62-2:21 of the ’560 Patent merely
`
`describes how the device in Figure 1 works and contains no language suggesting
`
`that the device in Figure 1 was publicly accessible prior to September 22, 1999.
`
`(Ex. 1001.) Thus, Petitioner also fails to demonstrate that the description of Figure
`
`1 in the ’560 Patent constitutes a prior art patent or printed publication. See, e.g.,
`
`Knightbright Elec. Co. LTD v. Cree, Inc., Case No. IPR2015-00746, Paper 8 at 7
`
`(P.T.A.B. August 20, 2015) (denying institution in part because the statements in
`
`the challenged patent discussed the use of particular materials, but did not admit
`
`such use was prior art).
`
`-10-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-00072
`Third, Petitioner and its expert rely on the Applicant’s attorney statements in
`
`the file history of the ’560 Patent, suggesting that the device in Figure 1 suffered
`
`from the problem of uneven crimping forces. (Pet. at 73 (citing Ex. 1002 at 65);
`
`Ex. 1011 at ¶ 152 (citing Ex. 1002 at 65).) The statements relied on by Petitioner
`
`were made in January 2004, more than four years after the critical date of
`
`September 22, 1999. Petitioner makes no showing that the 2004 attorney
`
`statements were in the public domain prior to the critical date of September 22,
`
`1999. Thus, Petitioner fails to demonstrate that the statements regarding the device
`
`in Figure 1 of the ’560 Patent constitute prior art patents or printed publications.
`
`See, e.g., Knightbright Elec. Co. LTD v. Cree, Inc., Case No. IPR2015-00746,
`
`Paper 8 at 7 (P.T.A.B. August 20, 2015) (denying institution in part because the
`
`expert declaration in a related proceeding was not a prior art patent or printed
`
`publication).
`
`In sum, Petitioner fails to establish that the alleged AAPA qualifies as a
`
`prior art patent or printed publication.2 The Petition, based primarily on the
`
`alleged AAPA, should be denied for this reason alone.
`
`2 Without any explanation or analysis, Petitioner relies on a non-binding decision
`
`in Intri-Plex Tech., Inc. v. Saint-Gobain Performance Plastics Rencol Ltd., Case
`
`No. IPR2014-00309, Paper 83 (P.T.A.B. Mar. 23, 2014) for the general proposition
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`Footnote continued on next page
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`Patent Owner’s Preliminary Response
`IPR2017-00072
`VI. EVEN IF THE ALLEGED AAPA COULD BE CONSIDERED, THE
`PETITION SHOULD STILL BE DENIED BECAUSE THE SAME OR
`SUBSTANTIALLY THE SAME ART AND ARGUMENTS WERE
`PREVIOUSLY PRESENTED TO THE OFFICE
`
`Even if the alleged AAPA is deemed a prior art patent or printed publication,
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`the Board should exercise its discretion to deny institution under § 35 U.S.C.
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`§ 325(d) because all of Petitioner’s references and arguments are the same or
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`substantially the same as the references and arguments previously presented to the
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`Patent Office during the prosecution of the ’560 Patent.
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`Footnote continued from previous page
`that “a patent applicant’s prior art admissions are prior art for purposes of inter
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`partes review.” (Pet. at 36-37.) Even if Intri-Plex could be relied upon, it is
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`readily distinguishable. The specification of the patent at issue in Intri-Plex
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`repeatedly stated that the prior art in question was “known,” thus confirming its
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`prior art status. Intri-Plex at 19-20. Here, there is no such statements or
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`statements to such effect in the specification of the ’560 Patent. Further, as
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`discussed above, Figure 1 was not labeled “PRIOR ART” as of the critical date of
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`the ’560 Patent. Moreover, as discussed above, Figure 1 is Patent Owner’s own
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`work, thus disqualifying it as prior art under pre-AIA 35 U.S.C. § 103(c) and
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`precluding the application of the prior art by admission doctrine.
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`Patent Owner’s Preliminary Response
`IPR2017-00072
`Institution of inter partes review is subject to the Board’s discretion. See
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`37 C.F.R. § 42.108(b). Specifically, under 35 U.S.C. § 325(d), the Board has
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`discretion to reject a petition for inter partes review because “the same or
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`substantially the same prior art or arguments previously were presented to the
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`Office.” Here, the same alleged AAPA and Morales were already considered by
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`the Examiner during the prosecution of the ’560 Patent. The remaining references
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`relied on by Petitioner, Sabbaghian and Baker, are substantially the same as prior
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`art considered by the Examiner during the prosecution of the ’560 Patent. The
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`Board should not second-guess the Examiner’s decision to allow the ’560 Patent in
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`view of the same or substantially the same references and arguments.
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`A.
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`The Examiner Repeatedly Considered The Alleged AAPA
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`In each of four grounds of challenges, Petitioner contends that the alleged
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`AAPA discloses every limitation of the challenged claims, except for the shape and
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`arrangement of the blades that form the claimed polygonal aperture. (Pet. at 37.)
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`However, the Examiner already considered the same alleged AAPA during the
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`prosecution of the ’560 Patent and deemed the claims patentable over the alleged
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`AAPA.
`
`In an October 22, 2003 Office Action, the Examiner rejected all then-
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`pending claims as obvious over the alleged AAPA in view of U.S. Patent No.
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`5,261,263 (“Whitesell”). (Ex. 1002 at 74-76; Ex. 1003.) The Examiner discussed
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`Patent Owner’s Preliminary Response
`IPR2017-00072
`the teachings of the alleged AAPA extensively, stating that it taught every
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`limitation of the then-pending claims, except for the specific shape and
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`arrangement of the blades. (Ex. 1002 at 74-76.) For example, the Examiner
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`reasoned that the alleged AAPA “teaches a stent crimper comprising: a plurality of
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`movable dies 24 arranged to form an iris, the dies 24 disposed about an aperture
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`26, the aperture 26 having a center” and that the alleged AAPA “teaches the
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`invention cited with the exception of each of the dies having a longitudinal axis
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`which is tangent to the aperture 26.” (Id. at 74.) According to the Examiner, it
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`would have been obvious to combine the alleged AAPA with Whitesell “in order
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`to provide a symmetric crimping deformation.” (Ex. 1002 at 74; see also id. at 74-
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`75 (“It is noted that Whitesell recognizes the benefits of using radial applying
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`crimping forces over linearly applied forces like the one taught by AAPA” (citing
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`Whitesell at 1:14-20)).)
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`In the same Office Action, the Examiner also rejected all then-pending
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`claims under the judicially created doctrine of obviousness-type double patenting
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`as being unpatentable over U.S. Patent No. 6,360,577 in light of the alleged
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`AAPA. (Id. at 76-78.) The Examiner stated that the alleged AAPA “teaches that it
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`is known that a stent is disposed about a medical balloon and the balloon is
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`disposed about a catheter . . . and a loading device (see fig. 1 outside of aperture
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`26).” (Id. at 78.) The Examiner further reasoned that “[i]t would have been
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`Patent Owner’s Preliminary Response
`IPR2017-00072
`obvious to one of ordinary skill in the art, have a stent disposed about a medical
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`balloon with the medical balloon disposed about the catheter and a loading device,
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`in light of the teaching of [AAPA] in order to provide a stent that can be used for
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`body vessels and in order to align the stent to the crimper.” (Id.)
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`Subsequently, the Applicant amended the claims and distinguished the
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`invention over the alleged AAPA. (Id. at 64-66.) The Applicant argued that:
`
`form an iris defining an aperture of a
`The AAPA does not
`substantially regular polygonal shape.
`Instead the AAPA has
`members which move radially inward and outward. An iris defining
`an aperture with a substantially regular polygonal shape acts about an
`opening or aperture such that the opening or aperture maintain a
`similar geometric shape while minimizing or maximize the size of the
`aperture. The AAPA does not maintain a similar geometric shape
`while maximizing and minimizing the size of the aperture.
`Instead,
`the AAPA manipulates the stent to be crimped by having elongate
`portions poke radially inward and press portions of the stent in order
`to minimize the size of the stent.
`The aperture is not being
`minimized; elongate members are merely being introduced into the
`aperture to crimp the stent. As these limitations are not disclosed or
`suggested in the AAPA and are not found in Whitesell, amended
`independent claim 27 is in condition for allowance.
`(Id. at 65.) In light of the Applicant’s argument (and amendment), the Examiner
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`withdrew the rejections over the alleged AAPA and later allowed the application
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`claims over the teachings of the alleged AAPA. (Id. at 44-50, 4.)
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`In sum, through the Applicant’s mistaken acquiescence that the alleged
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`AAPA is prior art, the Examiner thoroughly considered the alleged AAPA (and the
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`Applicant’s amendment and argument in view of the alleged AAPA) and
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`Patent Owner’s Preliminary Response
`IPR2017-00072
`ultimately determined that the claimed invention of the ’560 Patent is patentable
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`over the alleged AAPA. The Board should not consider the same alleged AAPA
`
`again. See Unified Patents Inc., v. John L. Berman, Case No. IPR2016-01571,
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`Paper 10 at 11 (P.T.A.B. Dec. 14, 2016) (rejecting institution under 35 U.S.C.
`
`§ 325(d) because “Russel was considered previously by the Office”); Cannon Inc.
`
`v. Papst Licensing GMBH & Co., Case No. IPR2016-01206, Paper 15 at 14
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`(P.T.A.B. Dec. 15, 2016) (denying institution under 35 U.S.C. § 325(d) because
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`“substantially the same argument regarding patentability of the claimed subject
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`matter” over the primary reference was previously presented to the Office).
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`While Petitioner acknowledges that the Examiner had already considered the
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`alleged AAPA and allowed the claims over the alleged AAPA during the
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`prosecution of the ’560 Patent (Pet. at 24-25), it fails to explain how its arguments
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`based on the same alleged AAPA are distinguished over the Examiner’s prior
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`consideration of the alleged AAPA. In fact, Petitioner expressly relies on the
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`Applicant’s attorney statements regarding the alleged AAPA in all of its grounds
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`of arguments. (Pet. at 73 (citing Ex. 1002 at 65), 85; Ex. 1011 at ¶ 152 (citing
`
`Ex. 1002 at 65).). To the extent that such statement