IPR2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC VASCULAR, INC.,
`MEDTRONIC VASCULAR GALWAY UNLIMITED COMPANY,
`MEDTRONIC LOGISTICS LLC, MEDTRONIC, INC.,
`AND MEDTRONIC USA, INC.,
`Petitioners,
`
`v.
`
`TMT SYSTEMS, INC,
`Patent Owner.
`
`IPR Trial No. IPR2021-01532
`U.S. Patent No. 7,101,393
`
`
`PETITIONERS’ REPLY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`
`
`II.
`
`TABLE OF CONTENTS
`INTRODUCTION ..................................................................................................... 1
`ARGUMENT ............................................................................................................. 3
`I.
`The Prior Art Discloses “Telescoping Arms.” ................................................ 3
`A.
`“Telescoping Arms” Can Expand Longitudinally. ............................... 3
`B.
`Lazarus Discloses “Telescoping Arms.” ............................................... 7
`The Prior Art Discloses The “M” Shape Terms. ........................................... 10
`A.
`PO’s Proposed Construction Of The “M” Shape Terms Should Be
`Rejected. .............................................................................................. 11
`Quiachon Discloses An “M” Shape Under PO’s Erroneous
`Construction. ....................................................................................... 14
`Hartley Discloses An “M” Shape Under PO’s Erroneous
`Construction. ....................................................................................... 16
`III. A POSA Would Have Been Motivated To Combine Quiachon And/Or
`Hartley With Lazarus With A Reasonable Expectation Of Success. ............ 17
`A. A POSA Had Clear Reason To Combine The References. ................ 17
`B.
`PO’s Arguments Against The Combination Fail. ............................... 19
`C.
`PO’s Argument That The Proposed Combination Could Not Be
`Engineered Without Problems Fails. ................................................... 24
`D. A POSA Would Have A Reasonable Expectation Of Success In
`Combining The References. ................................................................ 29
`IV. The Prosecution History Of The Child Application Confirms The
`Challenged Claims are Obvious. ................................................................... 30
`CONCLUSION ........................................................................................................ 31
`
`
`
`B.
`
`C.
`
`
`
`– ii –
`
`

`

`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`TABLE OF AUTHORITIES
`Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825
`F.3d 1373 (Fed. Cir. 2016) ............................................................................ 28
`Capital Mach. Co. v. Miller Veneers, Inc., 524 F. App’x 644 (Fed.
`Cir. 2013) ................................................................................................. 13, 30
`EWP Corp. v. Reliance Universal Inc., 755 F.2d 898 (Fed. Cir. 1985) .................. 20
`Graham v. John Deere Co., 383 U.S. 1 (1966) ......................................................... 3
`In re Etter, 756 F.2d 852 (Fed. Cir. 1985) (en banc) ............................................... 26
`In re Fulton, 391 F.3d 1195 (Fed. Cir. 2004) .......................................................... 22
`In re Gleave, 560 F.3d 1331 (Fed. Cir. 2009) ......................................................... 14
`In re Keller, 642 F.2d 413 (C.C.P.A. 1981) ...................................................... 23, 26
`In re Mouttett, 686 F.3d 1322 (Fed. Cir. 2012) ....................................................... 26
`In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988) ....................................................... 29
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) .................................... 21-22, 25
`Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340 (Fed. Cir.
`2004) ........................................................................................................ 13, 30
`Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) .................................... 26
`Precision Planting, LLC v. Deere & Co., IPR2019-01053, Paper 95
`(P.T.A.B. Dec. 4, 2020) ................................................................................. 23
`Realtime Data, LLC v. Iancu, 912 F.3d 1368 (Fed. Cir. 2019) ............................... 22
`Source Vagabond Sys. Ltd. v. Hydrapak, Inc., 753 F.3d 1291 (Fed.
`Cir. 2014) ....................................................................................................... 12
`Tile, Inc. v. Cellwitch Inc., No. IPR2020-00317, Paper 29 (P.T.A.B.
`May 13, 2021) ................................................................................................ 14
`ZUP, LLC v. Nash Mfg., Inc., 896 F.3d 1365 (Fed. Cir. 2018) ............................... 31
`– iii –
`
`
`
`
`
`

`

`IPR2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`INTRODUCTION
`
`As explained in the Petition, the primary references at issue (Quiachon and
`
`Hartley) each disclose an expandable endovascular attachment device that includes
`
`nearly all limitations of the challenged claims. A separate reference (Lazarus)
`
`discloses arms of an endovascular attachment device that telescope in the manner
`
`of a presentation pointer.
`
`Notably, Patent Owner’s Response (“POR”) does not dispute that (1)
`
`Quiachon and Hartley each disclose an expandable attachment device with arms in
`
`“the shape of a M” under the Board’s preliminary construction; (2) Lazarus
`
`discloses arms that telescope like a presentation pointer; (3) Quiachon, Hartley,
`
`and Lazarus each disclose endovascular attachment devices for treating abdominal
`
`aortic aneurysms (“AAA”); and (4) each reference teaches that the goal of its
`
`device is to obtain a tight seal between the device and wall of the blood vessel. As
`
`the Patent Office (“PTO”) previously determined during review of descendant
`
`applications to the ’393 patent, a POSA would have been motivated to apply the
`
`telescoping arms as taught in Lazarus to such an “M”-shaped attachment device to
`
`achieve the ’393 patent’s challenged claims.
`
`
`
`– 1 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`Patent Owner (“PO”) now seeks to avoid the straightforward conclusion that
`
`the challenged claims are obvious with three arguments.1 None has merit.
`
`First, although PO’s expert conceded that Lazarus discloses arms that
`
`telescope like a presentation pointer, PO nonetheless contends that Lazarus fails to
`
`disclose “telescoping arms” because the “telescoping arms” in Lazarus extend
`
`longitudinally rather than circumferentially. But nothing in the claims or
`
`specification precludes telescoping arms that extend longitudinally. Moreover, the
`
`sole claimed embodiment—Figure 13—features “telescoping arms” that extend in
`
`the longitudinal direction, so this is no meaningful distinction at all.
`
`Second, PO seeks to avoid Quiachon’s and Hartley’s disclosure of an “M”-
`
`shaped attachment device by rehashing claim construction arguments that both this
`
`Board and the PTO have repeatedly rejected. Contrary to PO’s assertions, nothing
`
`in the intrinsic or extrinsic record requires an “M” to have a specific configuration
`
`or to perform a specific function, and under the correct construction (i.e., the
`
`construction the Board applied in the Decision on Institution (“DOI”) and the PTO
`
`has applied eight times during prosecution) there is no dispute that the prior art
`
`
`1 PO does not separately address the dependent claims or offer additional
`
`arguments regarding Ground II. See POR.
`
`
`
`– 2 –
`
`

`

`
`
`teaches an “M”-shaped attachment device. And, even under PO’s erroneous claim
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`construction, both Quiachon and Hartley disclose an “M”-shaped attachment
`
`device.
`
`Finally, PO asserts the non-obviousness of the challenged claims by
`
`applying the wrong legal standard and ignoring the facts. As the Federal Circuit
`
`has repeatedly instructed, the proper inquiry in assessing obviousness is whether
`
`the claim limitations were disclosed in the prior art, whether it would have been
`
`obvious to a POSA at the time of the purported invention to combine those
`
`limitations, and whether a POSA would have had a reasonable expectation of
`
`success in doing so. Graham v. John Deere Co., 383 U.S. 1 (1966). Each of these
`
`criteria is met here.
`
`Accordingly, PO’s arguments should be rejected and the challenged claims
`
`found invalid.
`
`ARGUMENT
`
`I.
`
`The Prior Art Discloses “Telescoping Arms.”
`A.
`
` “Telescoping Arms” Can Expand Longitudinally.
`
`In the DOI, the Board correctly observed that it was undisputed that the
`
`challenged claims encompass “embodiments wherein an arm is expandable similar
`
`to a presentation pointer.” DOI, 27. Both Quiachon and Hartley disclose a
`
`
`
`– 3 –
`
`

`

`
`
`circumferentially expandable attachment device, and Lazarus discloses arms that
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`expand like a presentation pointer. See, e.g., Pet., 33-35; Ex.1072, ¶¶15, 17. PO
`
`does not dispute either fact. Instead, PO now argues that “telescoping arms” are
`
`required to expand circumferentially, rather than expanding like a presentation
`
`pointer. POR, 27-28; Ex.1072, ¶¶15-16. That argument should be rejected.
`
`First, the claims do not require the “telescoping arms” to expand
`
`circumferentially rather than longitudinally. While Claims 1 and 26 require the
`
`“attachment device” to be “expandable from a first state to a second state,”
`
`nothing in the claims defines “telescoping arms” to require circumferential
`
`expansion. (Ex.1001, claims 1, 26; Ex.1072, ¶18).2
`
`Second, the written description does not require the telescoping arms to
`
`expand circumferentially. The ’393 patent discloses two types of telescoping: (1)
`
`“each telescoping arm is similar to an expandable presentation pointer” or (2)
`
`“each telescoping arm may function like an accordion.” (Ex.1001, 2:38-40); Pet.,
`
`24. For presentation pointer telescoping, the patent explains that each telescoping
`
`arm is made of a plurality of segments that are “in slideable contact with one
`
`another and may be incrementally sized so as to fit within one another” (i.e.,
`
`
`2 Emphases added unless otherwise noted.
`
`
`
`– 4 –
`
`

`

`
`
`configured as a nested tube). (Ex.1001, 5:16-21). Thus, a presentation-pointer
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`“telescoping arm” simply requires nested tubes. (Ex.1072, ¶19).
`
`Indeed, the sole claimed embodiment of the ’393 patent, Figure 13, shows
`
`that “telescoping arms” do not drive circumferential expansion of the attachment
`
`device. As depicted in Figures 13A to 13G and Figures 13E to 13M, the
`
`circumferential expansion of the attachment device is due to its M-configuration,
`
`not to the telescoping aspect of its arms. (Ex.1072, ¶¶20-22). Patent Owner’s
`
`expert admitted this. (Ex.1066, 97:11-98:21).
`
`
`
`
`
`(Ex.1001, Figs. 13K-13M (annotated); Ex.1066, 97:11-98:21; Ex.1072, ¶¶20-22).
`
`Upon “telescoping” in Figure 13, an increase in the longitudinal height of
`
`the device is the primary result.
`
`
`
`– 5 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`
`
`(Ex.1001, Figs. 13M-13N (annotated); Ex.1066, 98:3-99:2; Ex.1072, ¶23).
`
`Accordingly, despite PO’s contrary arguments, presentation-pointer telescoping
`
`expands the longitudinal height of the device.
`
`Third, PO’s newfound argument that telescoping drives circumferential
`
`expansion directly conflicts with its prior filings in this IPR. In its POPR, PO
`
`annotated Figures 13M and 13N (reproduced below), explaining that when there is
`
`presentation pointer telescoping, the height of the device increases (green
`
`annotations). POPR, 17; (Ex.1072, ¶24).
`
`
`
`– 6 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`
`
`POPR, 17 (gridlines added; annotations in original); DOI, 25.
`
`Thus, PO’s contention that “telescoping arms” require circumferential
`
`expansion (and preclude longitudinal expansion) improperly seeks to import a
`
`limitation into the claims.
`
`B.
`
`Lazarus Discloses “Telescoping Arms.”
`
`PO’s expert concedes that Lazarus discloses arms that telescope like a
`
`presentation pointer. (Ex.1066, 198:20-199:4 (“Q. And there is no dispute that
`
`[Lazarus’s] telescoping members are telescoping in the manner of presentation
`
`
`
`– 7 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`pointer, correct? A. I don’t dispute that.”); Ex.1003, ¶141; Ex.1072, ¶25); Pet., 39;
`
`DOI, 46-47.3
`
`Pet., 39 (citing Ex.1006, Fig.7 (annotated)); (Ex.1072, ¶¶25-26).
`
`
`
`
`3 PO inaccurately alleges that Petitioners “admit that Quiachon and Hartley do not
`
`disclose telescoping arms.” POR, 26. Petitioners only agree that Quiachon and
`
`Hartley do not disclose “telescoping arms” under the proper claim construction,
`
`where each arm must telescope. (Ex.1072, ¶25). The Board did not reach the
`
`claim construction issue in the DOI. DOI, 23-27.
`
`
`
`– 8 –
`
`

`

`
`
`Nonetheless, PO attempts to side-step the evidence and its own expert’s
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`admissions by arguing that Petitioners “supply” a missing claim limitation through
`
`Dr. Chaikof. POR, 29-32. Not so. Dr. Chaikof explained that Lazarus discloses
`
`“telescoping arms” and a POSA would have been motivated to apply Lazarus’s
`
`telescoping arms to the arms of the attachment device disclosed in either Quiachon
`
`or Hartley. (Ex.1003, ¶¶138-153, 225-237; Ex.1072, ¶27); DOI, 46, 53.
`
`Moreover, while the claims require the arms of the “attachment device” to be
`
`“operatively connected to one another so as to form a perimeter of variable length”
`
`(Ex.1001, claim 1), both Quiachon and Hartley disclose that limitation. Pet., 43-
`
`45, 70-72; (Ex.1003, ¶¶154-160, 244-252; Ex.1072, ¶17).
`
`PO’s cited cases are readily distinguishable. POR, 29-32. In each instance,
`
`the patent challenger relied on the knowledge of a POSA or conclusory,
`
`unsupported arguments to supply a claim limitation that was not disclosed by the
`
`prior art. That is not the case here. The prior art discloses each limitation of the
`
`challenged claims (DOI, 44-50, 52-54), and Dr. Chaikof explains why a POSA
`
`would have been motivated to combine the art. E.g., Pet., 36-86; (Ex.1003, ¶¶129-
`
`284; DOI, 44, 52).
`
`
`
`– 9 –
`
`

`

`
`
`II. The Prior Art Discloses The “M” Shape Terms.
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`In the DOI, the Board correctly determined that the “M”-shape terms should
`
`be construed according to “their plain and ordinary meaning, which can include
`
`‘M’ shapes wherein the arms forming an M are equal in length, as well as ‘M’
`
`shapes wherein the arms differ in length.” DOI, 31; (Ex.1072, ¶29).4 That
`
`construction is consistent with the claim language, specification, prosecution
`
`history, a POSA’s knowledge, and the PTO’s prior analyses. PO does not dispute
`
`that Quiachon and Hartley each disclose an attachment device with arms in an “M”
`
`shape under the Board’s preliminary construction, which the Board should
`
`maintain. DOI, 45-46. And, even if PO’s unsupported construction—which has
`
`already been rejected at the PTO at least nine times—were adopted, each of
`
`Quiachon and Hartley would still disclose the “M”-shape terms. (Ex.1072, ¶28).
`
`
`4 The Board also offered preliminary constructions for several other terms. DOI,
`
`28-37. For purposes of this IPR, Petitioners accept the Board’s preliminary
`
`constructions, as the prior art discloses each claim limitation under those
`
`constructions. DOI, 37-54; Pet., 33-86; Ex.1072, ¶¶9-12.
`
`
`
`– 10 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`PO’s Proposed Construction Of The “M” Shape Terms Should Be
`Rejected.
`
`A.
`
`First, nothing in the claims limits an “M” to a specific configuration (a
`
`capital ‘M’ with middle arms that differ in length from the outer arms). (Ex.1003,
`
`¶120; Ex.1044, ¶¶92-93; Ex.1072, ¶30); DOI, 30-31 (“[T]he record is completely
`
`silent on the issue of the lengths of the arms contained in the M.”). The claims
`
`simply recite that the telescoping arms are arranged in “the shape of a M,” “the
`
`shape of multiple Ms,” or an “M configuration.” (Ex.1001, claims 1, 2, 26;
`
`Ex.1072, ¶30). PO suggests that the claims support its construction because claim
`
`1 recites “M” shapes and claim 14 recites “V” shapes. POR, 13-14. That one
`
`claim recites “Ms” and another “Vs” says nothing about whether arms in an “M”
`
`have different lengths. Rather, the difference is that an “M” shape and “V” shape
`
`have a different number of arms. (Ex.1072, ¶30); DOI, 30 (“[A]ny such
`
`distinction [between “Ms” and “Vs”] begins and ends with the number of arms that
`
`the shape contains, i.e., the M having 4 arms and the V having 2 arms.”).
`
`Second, PO argues that the written description “suggests that an M should
`
`be different than two inverted adjacent Vs.” POR, 14. But nothing in the written
`
`
`
`– 11 –
`
`

`

`
`
`description suggests that Ms and Vs have different length arms.5 (Ex.1003, ¶120;
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`Ex.1044, ¶¶92-93; Ex.1072, ¶31-33). Rather, the written description simply refers
`
`to M-springs and V-springs as alternative embodiments to form a connection
`
`between two points, which confirms that the only difference is the number of arms.
`
`(Ex.1001, Fig.9, 6:22-38; Ex.1003, ¶120; Ex.1044, ¶93; Ex.1072, ¶31).
`
`Third, contrary to PO’s suggestion, the prosecution history does not
`
`distinguish between “Ms” and “Vs.” POR, 14. It instead equates arms in an “M”
`
`shape with those in a “V” shape, with the sole difference being the number of arms
`
`counted. (Ex.1002, 147 (“[T]he telescoping arms ‘zigzag’ back and forth in
`
`forming the perimeter or appear as a series of Ms or Vs.”); Ex.1003, ¶120;
`
`Ex.1044, ¶¶94-96; Ex.1072, ¶34).
`
`Fourth, prior to the ’393 patent, the letter “M” was not a term of art, and a
`
`POSA would not have understood an “M” to be limited to a specific configuration.
`
`
`5 The POPR argued that Figures 13 and 15 show arms of an M that differ in length,
`
`but the POR abandons that argument. POPR, 25. That is unsurprising, as the
`
`figures do not show arms that differ in length. DOI, 30-31; (Ex.1003, ¶120;
`
`Ex.1044, ¶¶92-93; Ex.1072, ¶32); Source Vagabond Sys. Ltd. v. Hydrapak, Inc.,
`
`753 F.3d 1291, 1300 (Fed. Cir. 2014).
`
`
`
`– 12 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`(Ex.1003, ¶120; Ex.1044, ¶¶91; Ex.1072, ¶35). Significantly, the ’393 patent’s
`
`sole inventor agrees. (Ex.1049, 266 at 73:2-17; Ex.1072, ¶36). PO’s contrary
`
`argument is supported by nothing more than conclusory expert testimony that has
`
`never even been subjected to cross examination and thus lacks any significant
`
`evidentiary value. PO’s expert cites nothing other than the Declaration of Dr. John
`
`Collins from the ’331 Application prosecution, which has been repeatedly rejected
`
`at the PTO, including in a July 2022 office action. (Ex.1070, 12; Ex.1048, 506-
`
`516, 558-569, 860-872; Ex.1072, ¶37).
`
`Finally, PO’s attempt to dismiss the relevance of the ’331 Application
`
`should be rejected. As explained in the Petition, the PTO and Board addressed and
`
`rejected PO’s argument that the ’393 patent’s written description discloses an “M”
`
`with inner and outer arms that differ in length. Pet., 30-31; (Ex.1003, ¶¶99-107;
`
`Ex.1072, ¶38). That is relevant, as the same terms are at issue here.6 See Capital
`
`Mach. Co. v. Miller Veneers, Inc., 524 F. App’x 644, 649 (Fed. Cir. 2013);
`
`Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1349–50 (Fed. Cir. 2004).
`
`Accordingly, the Board’s preliminary construction for the “M” shape terms should
`
`
`6 PO and Dr. Berry contend that the ’331 application is irrelevant; yet cite the ’331
`
`Application to support their claim construction position. (Ex.2083, ¶65).
`
`
`
`– 13 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`be adopted. Under that construction, there is no dispute that both Quiachon and
`
`Hartley disclose attachment devices comprising arms in the shape of an M.
`
`B. Quiachon Discloses An “M” Shape Under PO’s Erroneous
`Construction.
`
`Quiachon discloses arms in the “shape of an M” even under PO’s erroneous
`
`proposed construction. Pet., 45-49; DOI, 44-45. PO’s primary argument to the
`
`contrary is that Quiachon does not expressly describe its stent as an “M.” POR,
`
`56-59. However, it is well established that the prior art need not use the same
`
`words as the claims; all that matters is whether a POSA would have understood the
`
`reference to disclose the claim limitation. Tile, Inc. v. Cellwitch Inc., No.
`
`IPR2020-00317, Paper 29, at 18 (P.T.A.B. May 13, 2021); In re Gleave, 560 F.3d
`
`1331, 1334 (Fed. Cir. 2009) (“reference need not satisfy an ipsissimis verbis test”).
`
`A POSA would have readily understood that Quiachon discloses arms in an “M”
`
`shape. Pet, 45-49; (Ex.1003, ¶¶161-172; Ex.1072, ¶¶39-41).
`
`PO mischaracterizes Quiachon’s disclosure, which is not “silent” about its
`
`configuration. POR, 56-57. Quiachon states that its attachment device has
`
`staggered apices such that “not all of the struts are of equal length.” (Ex.1004,
`
`15:39-40; see also id., Fig, 17, 15:3-59). Quiachon’s configuration is clearly
`
`depicted in Figure 17, which shows that its device has inner arms (in blue) that
`
`differ in length from the outer arms (in green). (Ex.1004, Fig.17; Ex.1072, ¶39).
`
`
`
`– 14 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`
`
`(Ex.1004, Fig.17 (annotations added); Ex.1072, ¶39); POR, 57.
`
`Semantics aside, that Quiachon uses the letters “V” and “U” to describe
`
`other components does not negate its disclosure of “M”-shaped arms. POR, 57-59;
`
`(Ex.1072, ¶41). For example, while Quiachon describes the lumen piecing
`
`members (in yellow above) as “V-shaped,” that component has one apex and two
`
`arms. (E.g., Ex.1005, Fig.17, 15:64-66; Ex.1072, ¶41). This is consistent with a
`
`POSA’s understanding that the only difference, if any, is the number of arms.
`
`(Ex.1072, ¶41; see also Ex.1070, at 15 (“Since there are not always clear starting
`
`and stopping points for each strut [the] zigzag shapes can be broadly interpreted to
`
`have V, U, W, M, N and Z shapes”)).
`
`
`
`– 15 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`C. Hartley Discloses An “M” Shape Under PO’s Erroneous
`Construction.
`
`Hartley likewise discloses arms in the “shape of an M” even under PO’s
`
`erroneous construction. Pet, 73-76. PO again argues that Hartley does not disclose
`
`an “M” shape because it does not use the letter “M.” POR, 59. As explained
`
`above, that is incorrect. A POSA would have readily understood that Hartley
`
`discloses arms in an “M” shape. Pet, 73-76; (Ex.1003, ¶¶245-251; Ex.1072, ¶¶42-
`
`43).
`
`
`
`Pet., 74-75 (citing Ex.1005, Fig.2 (annotated)); (Ex.1003, ¶¶245-251).
`
`PO’s argument that Hartley does not disclose an “M” because its stent is not
`
`capable of “differential, multi-planar movement” also lacks merit. POR, 60-61;
`
`(see also Ex.1066, 57:12-21; 61:6-62:20; Ex.1072, ¶¶44-47). Not even PO’s
`
`erroneous construction imports those claim requirements. POR, 13-16. Further,
`– 16 –
`
`
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`the Board already recognized that PO’s functionality arguments have no basis.
`
`DOI, 34-37.
`
`Regardless, even if an “M” shape requires this specific functionality, Hartley
`
`discloses an M-shape. A POSA would have understood that Hartley discloses a
`
`stent that is capable of “multi-planar expansion.” Pet., 76; (Ex.1072, ¶¶46-47). As
`
`explained by Dr. Chaikof—a principal investigator on multiple clinical trials for
`
`endovascular stent grafts prior to 2002 (Ex.1003, ¶¶7-8; Ex.1072, ¶46)7—a POSA
`
`would have understood that Hartley’s stent can expand in multiple planes to
`
`effectively treat an aneurysm. (Ex.1072, ¶¶46-47).
`
`III. A POSA Would Have Been Motivated To Combine Quiachon And/Or
`Hartley With Lazarus With A Reasonable Expectation Of Success.
`A. A POSA Had Clear Reason To Combine The References.
`
`The Petition demonstrates a clear motivation to combine Quiachon and/or
`
`Hartley with Lazarus under the well-established legal framework for obviousness.
`
`As PO’s expert acknowledged, prior to 2002, it was important to design a stent
`
`graft that would achieve two goals: (1) to maximally compress the stent to
`
`facilitate insertion through a femoral artery; and (2) to successfully expand the
`
`
`7 In contrast, Dr. Berry is not a surgeon and has never implanted an endovascular
`
`stent graft. (Ex.1066, 36:16-22; Ex.2083, Appendix A (CV)).
`
`
`
`– 17 –
`
`

`

`
`
`stent at the site of an aneurysm for a secure and precise fit, thereby reducing the
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`risk of endoleaks and migration. Pet., 40, 68; see also (Ex.1003, ¶¶144-145, 230-
`
`231; Ex.1066, 128:6-9; id., 157:13-158:8; see also id., 158:9-14 (“Q. [The ability
`
`to compress a stent graft into a delivery catheter has] always been an important
`
`design consideration for as long as endovascular AAA repair has been performed,
`
`correct? A. It is to my knowledge an important design consideration.”) (objection
`
`omitted); id. 157:13-18 (“Q. Would you agree that it’s always been an important
`
`design consideration for an endovascular stent graft system to fit … the
`
`morphology of the patient’s vasculature? A. Of course that is an important design
`
`consideration.”)).
`
`Quiachon, Hartley, and Lazarus each express the importance of compressing
`
`a stent graft into a small profile for navigation through a blood vessel: Quiachon
`
`states that “an important objective of the present invention [is] to create a narrow
`
`profile for the attachment system 175 when the attachment system is constricted
`
`radially,” Pet., 35, 40-41; (Ex.1004, 15:43-49); Hartley explains that a goal of its
`
`device is to “compress[] the graft and plac[e] it into a sheath,” Pet., 35, 68;
`
`(Ex.1005, 4:18-34); Lazarus explains that “[t]he ability to be manipulated to a
`
`circumferentially smaller dimension allows the tubular body 22 to be positioned
`
`
`
`– 18 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`within a transportation means sized to fit within a vessel lumen.” (Ex.1006, 8:41-
`
`44).
`
`Each reference likewise expresses the importance of expanding a stent graft
`
`to obtain a tight fit between the device and the vessel wall: Quiachon states that the
`
`goal of its device is to expand a graft “from a first compressed or collapsed
`
`position to a second expanded position” to provide “a fluid tight seal between the
`
`graft and corporeal lumen wall,” Pet., 35, 40-41; (Ex.1004, 15:10-14); Hartley
`
`explains that a goal of its device is to “fit[] snugly” within a blood vessel, Pet., 35,
`
`68; (Ex.1005, 4:18-34); Lazarus expresses the desire to achieve “optimal fit within
`
`the vessel,” Pet., 35, 40-41, 68; (Ex.1006, 10:38-40). Given Lazarus’s teachings
`
`that its telescoping arms allow the device to be compressed for delivery and
`
`expanded to aid in fitting securely within the vessel, a POSA would have been
`
`motivated to apply Lazarus’s telescoping structure to the arms of either Quiachon’s
`
`or Hartley’s M-shaped attachment device. Pet., 41, 69; (Ex.1003, ¶¶147, 233).
`
`B.
`
`PO’s Arguments Against The Combination Fail.
`
`PO’s arguments against combining Lazarus with either Quiachon or Hartley
`
`fail.
`
`First, PO’s assertion that Lazarus’s longitudinal support structures do not
`
`help secure the graft (POR, 31) is expressly contradicted by Lazarus itself, which
`
`
`
`– 19 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`teaches that its longitudinal support structures are designed to “provide an optimal
`
`fit within the vessel.” (Ex.1006, 10:38-40). Lazarus also teaches that its
`
`telescoping arms allow the graft “to be flexible and adjustable to thereby facilitate
`
`insertion and placement of the graft within a vessel” (Ex.1006, 2:10-14, 10:33-
`
`411; Ex.1003, ¶¶145-146), and “provide means for limiting movement in the
`
`intraluminal graft within the vessel” (Ex.1006, 2:22-26). A POSA would readily
`
`recognize that Lazarus’s telescoping arms provide fit benefits not only in the
`
`longitudinal direction, but also help support and anchor the graft within the vessel,
`
`as PO’s own expert acknowledges. (Ex.1072, ¶56; Ex.2083, ¶182; Ex.1066,
`
`203:1-9).
`
`Second, PO’s arguments rest on an incorrect legal standard. Under the
`
`correct legal standard, regardless of whether Lazarus’s telescoping arms contribute
`
`to attachment within the blood vessel, a POSA would have been motivated to
`
`apply Lazarus’s telescoping structure to aid in compression and expansion because
`
`a reference “is not limited to the particular invention it is describing and attempting
`
`to protect.” EWP Corp. v. Reliance Universal Inc., 755 F.2d 898, 907 (Fed. Cir.
`
`1985). Here, a POSA would be motivated to replace the arms of Quiachon and/or
`
`Hartley with Lazarus’s telescoping structure given the well-known design goals of
`
`compression and expansion discussed above. (Ex.1072, ¶¶48-62). This is
`
`
`
`– 20 –
`
`

`

`
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`particularly true given that circumferential telescoping was well-known in the art.
`
`(Ex.1009, 4:42-67, Fig.9; Ex.1039, Fig.4).
`
`Third, PO’s argument that nothing in the references suggests a need to
`
`“further improve” Quiachon’s and/or Hartley’s attachment systems (POR, 35-36)
`
`is likewise incorrect. Obviousness requires only “application of a known
`
`technique to a piece of prior art ready for the improvement.” KSR Int’l Co. v.
`
`Teleflex Inc., 550 U.S. 398, 417 (2007). As explained above, the goal of
`
`Quiachon’s device is to expand a graft to provide “a fluid tight seal between the
`
`graft and corporeal lumen wall” (Ex.1004, 15:10-14), and a goal of Hartley’s
`
`device is to “fit[] snugly” within a blood vessel. (Ex.1005, 4:18-34). Although
`
`Quiachon and Hartley describe certain benefits of their systems, as PO’s expert
`
`acknowledges, endoleaks (i.e., leakage from inadequate seal) continued to be a
`
`known problem prior to the alleged invention. (Ex.1072, ¶51; Ex.1066, 154:2-15
`
`(“[E]ndoleaks were a problem then” and “the problem of endoleaks has not been
`
`solved completely”)). The attachment devices disclosed in Quiachon and Hartley
`
`were thus ready for improvement, which a POSA would have sought to achieve by
`
`employing Lazarus’s telescoping arms. (Ex.1072, ¶¶49-52).
`
`Moreover, a need to “further improve” a device need not be explicit in the
`
`prior art, but can be supplied by design incentives and a POSA’s general
`
`
`
`– 21 –
`
`

`

`
`
`knowledge. KSR, 550 U.S. at 418; Realtime Data, LLC v. Iancu, 912 F.3d 1368,
`
`IPR 2021-01532
`U.S. Patent No. 7,101,393
`Petitioners’ Reply
`
`
`1374 (Fed. Cir. 2019) (“A motivation to combine may be found explicitly or
`
`implicitly in market forces; design incentives; the interrelated teachings of multiple
`
`patents; any need or problem known in the field of endeavor at the time of
`
`invention and addressed by the patent; and the background knowledge, creativity,
`
`and common sense of the person of ordinary skill.”) (internal quotations omitted).
`
`And here there were clear design incentives to improve Quiachon’s and/or
`
`Hartley’s devices. As PO’s expert explained, a POSA would understand that the
`
`ability to “compress a stent graft into a delivery catheter,” expand the device to “fit
`
`the morphology of the patient’s vasculature,” and “reduce the incidence of
`
`endoleaks” are each important design considerations. (Ex.1066, 157:13-159:9; see
`
`also Ex.1003, ¶¶147, 233).
`
`Fourth, PO’s claim that “there are many ways” to improve sealing does not
`
`negate obviousness. POR, 37-38. Even were PO correct, the “mere disclosure of
`
`alternative designs does not teach away.” In re Fulton, 391 F.3d 1195, 1201 (Fed.
`
`Cir. 2004). Rather, “[w]hen there is a design need or market pressure to solve a
`
`problem,” a POSA “has g