throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`______________
`
`Case IPR2017-00060
`Patent 8,992,608
`______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON CROSS-EXAMINATION
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`

`Pursuant to the Scheduling Order, Patent Owner Boston Scientific
`
`Scimed, Inc. (“Patent Owner”) hereby respectfully moves for consideration of the
`
`following observations on cross-examination.
`
`I.
`
`Observations On Cross-Examination Of Petitioner’s Declarant
`Larry Wood
`
`Observation #1. In Exhibit 2096, on page 8 line 25 through page 9 line 23,
`
`Mr. Wood testified that he does not have a medical degree or an engineering
`
`degree and that he is not an interventional cardiologist or a cardiac or vascular
`
`surgeon. This testimony is relevant to establish that Mr. Wood is not a person of
`
`ordinary skill in the art (“POSITA”) under either party’s proposed definition of
`
`ordinary skill. (See Paper 1 at 45-46; Paper 6 at 7.)
`
`Observation #2. In Exhibit 2096, on page 10 lines 3 through 8, Mr. Wood
`
`testified that he is not offering an opinion as to Patent Owner’s efforts to match up
`
`the claim elements of the ‘608 patent to the SAPIEN 3 device. This testimony is
`
`relevant to whether there is a nexus between the claimed invention and the
`
`commercial success of the SAPIEN 3. (See Paper 22 at 50-58; Paper 34 at 19-23;
`
`Ex. 1046 at ¶¶ 38-45.)
`
`Observation #3. In Exhibit 2096, on page 10 line 12 through page 11 line 6,
`
`Mr. Wood testified that a number of papers, including the PARTNER II S3i study
`
`sponsored by Petitioner, have determined an association between paravalvular
`
`leakage (“PVL”) and mortality. This testimony is relevant to whether there was a
`
`-1-
`
`

`

`long-felt need for a solution to PVL, such as that disclosed in the ‘608 patent. (See
`
`Paper 22 at 63-64; Paper 34 at 26; Ex. 1046 at ¶¶ 29-33.)
`
`Observation #4. In Exhibit 2096, on page 12 line 10 through page 13 line 6,
`
`Mr. Wood testified that he was aware of findings by clinicians that moderate to
`
`severe PVL was an independent predictor of mortality at one year and two years.
`
`This testimony is relevant to whether there was a long-felt need for a solution to
`
`PVL, such as that disclosed in the ‘608 patent. (See Paper 22 at 63-64; Paper 34 at
`
`26; Ex. 1046 at ¶¶ 29-33.)
`
`Observation #5. In Exhibit 2096, on page 54 line 7 through page 56 line 9,
`
`Mr. Wood testified that the finding that “the presence of paravalvular or total aortic
`
`regurgitation, mild, moderate or severe versus none or trace, after TAVR was
`
`associated with increased late mortality” in Exhibit 2097—an article discussing
`
`results of the PARTNER trial sponsored by Petitioner—was statistically
`
`significant. This testimony is relevant to whether there was a long-felt need for a
`
`solution to PVL, such as that disclosed in the ‘608 patent. (See Paper 22 at 63-64;
`
`Paper 34 at 26; Ex. 1046 at ¶¶ 29-33.)
`
`Observation #6. In Exhibit 2096, on page 16 lines 14 through 19, Mr. Wood
`
`testified that he does not think anybody believes that PVL is good for you and that
`
`“[e]veryone would rather have less of it than more of it.” This testimony is
`
`relevant to whether there was a long-felt need for a solution to PVL, such as that
`
`-2-
`
`

`

`disclosed in the ‘608 patent. (See Paper 22 at 63-64; Paper 34 at 26; Ex. 1046 at
`
`¶¶ 29-33.)
`
`Observation #7. In Exhibit 2096, on page 18 lines 9 through 15, Mr. Wood
`
`testified that the SAPIEN XT and the SAPIEN 3 were offered in the same sizes
`
`and, on page 30 lines 14 through 15, Mr. Wood testified that the “SAPIEN 3 has
`
`less paravalvular leakage than XT at some level.” This testimony is relevant to
`
`whether the problem of PVL had been solved before the ‘608 patent and, in
`
`particular, whether proper valve sizing was a complete solution to PVL. (See
`
`Ex. 1046 ¶ 29.)
`
`Observation #8. In Exhibit 2096, on page 22 line 25 through page 23
`
`line 10, Mr. Wood testified that “[t]here are certain risks to oversizing” and that
`
`“[i]f you oversize too much, you can actually tear the tissue or rupture the
`
`annulus.” This testimony is relevant to whether the problem of PVL had been
`
`solved before the ‘608 patent and, in particular, whether oversizing was a complete
`
`solution to PVL. (See Ex. 1046 ¶ 30.)
`
`Observation #9. In Exhibit 2096, on page 24 line 13 through page 25
`
`line 22, Mr. Wood testified that the author of Exhibit 2059, which Mr. Wood cites
`
`in his declaration (Ex. 1046 ¶ 30), believes that “you don’t have to oversize as
`
`aggressively with the Sapien 3 to achieve paravalvular leak reduction” and “if you
`
`do less oversizing, could reduce your risk of annular rupture.” This testimony is
`
`-3-
`
`

`

`relevant to whether the problem of PVL had been solved before the ‘608 patent
`
`and, in particular, whether oversizing was a complete solution to PVL.
`
`(See Ex. 1046 ¶ 30.)
`
`Observation #10. In Exhibit 2096, on page 33 line 14 through page 36
`
`line 15, Mr. Wood testified that, in the 2006 time frame, “the most challenging
`
`thing about paravalvular leak was we were still trying to solve something we didn’t
`
`fully understand” and “we had this PV leak problem, but we didn’t really
`
`understand the source of the problem because we didn’t understand the
`
`fundamental environment we were working in.” This testimony is relevant to
`
`whether the problem of PVL had been solved before the ‘608 patent.
`
`(See Ex. 1046 ¶¶ 18-28.)
`
`Observation #11. In Exhibit 2096, on page 36 lines 16 through 24,
`
`Mr. Wood testified that “a primary consideration” in Petitioner’s decision not to
`
`add an outer skirt to the first two generations of its TAVR valve, the SAPIEN and
`
`SAPIEN XT, was “concern about vascular complications due to an increase in
`
`crimp profile” and that, in the SAPIEN 3, Petitioner was able to add a skirt without
`
`compromising crimp profile. This testimony is relevant to whether Petitioner had
`
`independently conceived of the invention of the ‘608 patent, which shows how the
`
`fabric seal has a greater impact on profile in the deployed configuration than it
`
`does in the delivery configuration. (See Ex. 1046 ¶ 25; Ex. 1001 FIGS. 32, 33.)
`
`-4-
`
`

`

`Observation #12. In Exhibit 2096, on page 38 lines 2 through 15, Mr. Wood
`
`testified that Petitioner never conducted live human studies with the valves from its
`
`Patriot project, never filed for approval to start a clinical trial of the valves from
`
`the Patriot project, and never submitted data in support of commercial approval for
`
`such valves. This testimony is relevant to whether Petitioner had independently
`
`conceived of the invention of the ‘608 patent. (See Ex. 1046 ¶¶ 22, 23.)
`
`Observation #13. In Exhibit 2096, on page 38 line 25 through page 39
`
`line 6, Mr. Wood testified that the cloth on the crown valve from Petitioner’s
`
`Patriot project was “not puffy” and was “pretty much sewn everywhere.” This
`
`testimony is relevant to whether Petitioner had independently conceived of the
`
`invention of the ‘608 patent and, in particular, whether the crown valve would
`
`form “flaps” and “pockets” as claimed in the ‘608 patent. (See Ex. 1046 ¶¶ 22, 23;
`
`Ex. 1001 col. 22:21-46.)
`
`Observation #14. In Exhibit 2096, on page 39 line 7 through page 40
`
`line 24, Mr. Wood testified that he did not have any reason to believe that
`
`Exhibit 2063 was not created in connection with Petitioner’s business or
`
`maintained in Petitioner’s files. This testimony is relevant to whether
`
`Exhibit 2063, in which the designers of the SAPIEN 3 state that
`
`invention of the ‘608 patent yielded unexpected results. (See Ex. 1046 ¶ 37.)
`
`is evidence that the
`
`-5-
`
`

`

`Observation #15. In Exhibit 2096, on page 40 line 25 through page 42
`
`line 22, Mr. Wood testified that “TAVR doctors are well aware of the outer skirt
`
`on Sapien 3,” “some doctors certainly attribute some of the improved PVL data for
`
`Sapien 3 to the skirt,” and that there is “a common belief that the skirt contributes
`
`to the reduction of paravalvular leak.” This testimony is relevant to whether the
`
`SAPIEN 3 received industry praise directed specifically to its fabric seal.
`
`(See Ex. 1046 ¶ 36.)
`
`Observation #16. In Exhibit 2096, on page 48 lines 18 through 25,
`
`Mr. Wood testified that some of the success and popularity of Petitioner’s
`
`SAPIEN 3 valve is due to reductions in PVL. This testimony is relevant to
`
`whether the SAPIEN 3 enjoyed commercial success as a result of its fabric seal.
`
`(See Ex. 1046 at ¶¶ 38-45.)
`
`Observation #17. In Exhibit 2096, on page 49 lines 10 through 18,
`
`Mr. Wood testified that all of the features of Petitioner’s SAPIEN 3 product,
`
`including the outer skirt, contributed to its success. This testimony is relevant to
`
`whether the SAPIEN 3 enjoyed commercial success as a result of its fabric seal.
`
`(See Ex. 1046 at ¶¶ 38-45.)
`
`Observation #18. In Exhibit 2096, on page 49 line 24 through page 52
`
`line 23, Mr. Wood testified that Exhibit 2099 showed
`
`-6-
`
`

`

`(Ex. 2099 at 26.) This testimony is relevant to whether the SAPIEN 3 enjoyed
`
`commercial success. (See Ex. 1046 at ¶¶ 38-45.)
`
`Observation #19. In Exhibit 2096, on page 52 line 24 through page 53
`
`line 25, Mr. Wood explained the statement in Exhibit 2099 that
`
`relevant to whether the SAPIEN 3 enjoyed commercial success. (See Ex. 1046 at
`
`This testimony is
`
`¶¶ 38-45.)
`
`-7-
`
`

`

`II. Observations On Cross-Examination Of Petitioner’s Declarant
`Nigel Buller, M.D.
`
`Observation #20. In Exhibit 2094, on page 52 lines 1 through 5, Dr. Buller
`
`testified that he did not consider any secondary considerations of non-obviousness
`
`regarding the ‘608 patent other than copying. This testimony is relevant to
`
`determining the probative value of Dr. Buller’s opinions regarding obviousness of
`
`the ‘608 patent. (See generally Exs. 1007, 1045.)
`
`Observation #21. In Exhibit 2094, on page 11 lines 6 through 18, Dr. Buller
`
`testified that he has only implanted two stent grafts in the aorta during his entire
`
`career, neither of which was an abdominal aortic aneurysm (“AAA”) stent graft as
`
`found in the prior art at issue here. This testimony is relevant to determining the
`
`probative value of Dr. Buller’s opinions regarding obviousness of the ‘608 patent
`
`relative to those of Drs. Manganaro and Brecker. (See generally Exs. 1007, 1045.)
`
`Observation #22. In Exhibit 2094, on page 16 lines 12 through 20,
`
`Dr. Buller testified that he has never performed a surgical cut down of the aorta,
`
`which results in direct observation of the aorta’s anatomy. (Id.) This testimony is
`
`relevant to determining the probative value of Dr. Buller’s opinions regarding
`
`obviousness of the ‘608 patent. (See generally Exs. 1007, 1045.)
`
`Observation #23. In Exhibit 2094, on page 19 line 16 through page 21
`
`line 21, Dr. Buller testified that the term “stability” in WO 03/047468 (Ex. 1004,
`
`“Spenser”) refers to reducing migration and that this term means different things in
`
`-8-
`
`

`

`different contexts of Spenser. This testimony is relevant to whether a POSITA
`
`would have combined Spenser’s valve with the AAA stent grafts’ skirts and, in
`
`particular, to disprove Petitioner’s contention (Paper 34 at 4) and Dr. Buller’s
`
`opinion (Ex. 1045 ¶ 28) that Spenser’s reference to “stability” refers to the valve’s
`
`construction rather than valve migration.
`
`Observation #24. In Exhibit 2094, on page 22 lines 10 through 24,
`
`Dr. Buller testified that the seal in WO 05/102015 (Ex. 1059, “Bergheim”) is
`
`tightly wrapped around the stent—i.e., it does not include excess material. This
`
`testimony is relevant to whether a POSITA would have combined Spenser’s valve
`
`with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
`
`contention (Paper 34 at 4-5) and Dr. Buller’s opinion (Ex. 1045 ¶ 30) that
`
`Bergheim demonstrates that excess material around a valve may improve stability
`
`of the device and prevent migration.
`
`Observation #25. In Exhibit 2094, on page 35 lines 1 through page 36
`
`line 6, Dr. Buller testified that the ‘608 patent solved the problem of PVL
`
`generally, not PVL in calcified diseased valves specifically. This testimony is
`
`relevant to whether a POSITA would have combined Spenser’s valve with the
`
`AAA stent grafts’ skirts and, in particular, to demonstrate Petitioner’s and Dr.
`
`Buller’s misunderstanding of the ‘608 patent, which specifically teaches that it
`
`solves the problem of PVL in “diseased aortic valve[s]” with “irregular” surfaces,
`
`-9-
`
`

`

`such as those afflicted with calcification. (Ex. 1001 col. 12:19-27, col. 14:21-29,
`
`FIGS. 13, 32-34.)
`
`Observation #26. In Exhibit 2094, on page 38 line 10 through page 39
`
`line 8, Dr. Buller testified that a POSITA would want to design a transcatheter
`
`aortic valve replacement (“TAVR”) device that worked in a calcified environment.
`
`This testimony is relevant to whether a POSITA would have combined Spenser’s
`
`valve with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
`
`contention (Paper 34 at 6-7) and Dr. Buller’s opinion (Ex. 1045 ¶ 40) that a
`
`POSITA would not have considered aortic calcification when designing a PVL
`
`solution.
`
`Observation #27. In Exhibit 2094, on page 43 line 15 through page 44
`
`line 24 and on page 45 line 24 through page 46 line 4, Dr. Buller did not dispute
`
`Dr. Manganaro’s opinion (Ex. 2079 ¶¶ 68-72) that the nature of diseased aortic
`
`annulus calcifications (where TAVR devices are implanted) is fundamentally
`
`different than the nature of aortic calcifications (where stent grafts are implanted),
`
`and admitted that he did not opine on this matter in his declarations. This
`
`testimony is relevant to whether a POSITA would have combined Spenser’s valve
`
`with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
`
`contention (Paper 34 at 6-7, 13-17) and Dr. Buller’s opinion (Ex. 1045 ¶¶ 40-47)
`
`-10-
`
`

`

`that AAA stent grafts were designed to seal leaks caused by calcifications like
`
`those found in the aortic annulus.
`
`Observation #28. In Exhibit 2094, on page 42 lines 6 through 11, Dr. Buller
`
`testified that the article published in 2005 by R.W. Jayalath et al. titled “Aortic
`
`Calcification (Ex. 1060, “Jayalath Article”) does not indicate whether aortic
`
`calcification is relevant to treating aortic aneurysms with stent grafts. This
`
`testimony is relevant to whether a POSITA would have combined Spenser’s valve
`
`with the AAA stent grafts’ skirts and, in particular, to disprove Petitioner’s
`
`contention (Paper 34 at 6-7) and Dr. Buller’s opinion (Ex. 1045 ¶¶ 46-47) that the
`
`Jayalath Article is evidence that AAA stent grafts were designed to seal leaks
`
`caused by calcifications like those found in the aortic annulus.
`
`Observation #29. In Exhibit 2094, on page 41 line 23 through page 42
`
`line 5, Dr. Buller testified that the Jayalath Article does not correlate aortic
`
`calcification with diseased aortic annulus calcification. This testimony is relevant
`
`to whether a POSITA would have combined Spenser’s valve with the AAA stent
`
`grafts’ skirts and, in particular, to disprove Petitioner’s contention (Paper 34 at 6-7)
`
`and Dr. Buller’s opinion (Ex. 1045 ¶¶ 46-47) that the Jayalath Article is evidence
`
`that AAA stent grafts were designed to seal leaks caused by calcifications like
`
`those found in the aortic annulus.
`
`-11-
`
`

`

`Observation #30. In Exhibit 2094, on page 52 lines 1 through 5, Dr. Buller
`
`testified that participation in the Reaven and Sacks study cited in the Jayalath
`
`Article (cited as evidence of the prominence of aortic calcifications) was limited to
`
`Hispanics with type 2 diabetes, which Dr. Buller admitted are not representative of
`
`all patients. This testimony is relevant to whether a POSITA would have
`
`combined Spenser’s valve with the AAA stent grafts’ skirts and, in particular, to
`
`disprove Petitioner’s contention (Paper 34 at 6-7) and Dr. Buller’s opinion
`
`(Ex. 1045 ¶¶ 46-47) that the Jayalath Article and Reaven and Sacks study are
`
`evidence that AAA stent grafts were designed to seal leaks caused by calcifications
`
`like those found in the aortic annulus.
`
`Observation #31. In Exhibit 2094, on page 62 line 17 through page 63
`
`line 7, Dr. Buller testified that he could not state that a TAVR device featuring an
`
`inner and outer skirt made of two pieces of the same material (Ex. 2095, Ex. A to
`
`Dr. Buller’s deposition) would not infringe the ‘608 patent. This testimony is
`
`relevant to whether there is a nexus between the claimed invention and the
`
`secondary considerations of non-obviousness regarding the SAPIEN 3 and, in
`
`particular, to disprove Petitioner’s contention (Paper 34 at 19-22) and Dr. Buller’s
`
`opinion (Ex. 1045 ¶¶ 11-14) that the SAPIEN 3 does not include a fabric seal as
`
`claimed in the ‘608 patent.
`
`-12-
`
`

`

`Observation #32. In Exhibit 2094, on page 68 lines 3 through 14, Dr. Buller
`
`testified that he could not state that Figure 32 of the ‘608 patent would infringe the
`
`‘608 patent if the skirt were made of two pieces of material, rather than a single
`
`piece of material as shown. This testimony is relevant to whether there is a nexus
`
`between the claimed invention and the secondary considerations of non-
`
`obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that Dr.
`
`Buller is confused by his own interpretation of “fabric seal,” as explained in
`
`Observation # 31.
`
`Observation #33. In Exhibit 2094, on page 68 line 15 through page 69
`
`line 17, Dr. Buller testified that the combination of the SAPIEN 3’s inner and outer
`
`skirts meets the claim elements of the ‘608 patent. This testimony is relevant to
`
`whether there is a nexus between the claimed invention and the secondary
`
`considerations of non-obviousness regarding the SAPIEN 3 and, in particular, to
`
`disprove Petitioner’s contention (Paper 34 at 17-22) and Dr. Buller’s opinion
`
`(Ex. 1045 ¶¶ 11-14) that the SAPIEN 3 does not include a fabric seal as claimed in
`
`the ‘608 patent.
`
`Observation #34. In Exhibit 2094, on page 71 line 22 through page 72
`
`line 3, Dr. Buller testified that the SAPIEN 3’s commissure windows do not move
`
`independently of the frame. This testimony is relevant to whether there is a nexus
`
`between the claimed invention and the secondary considerations of
`
`-13-
`
`

`

`non-obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that
`
`Petitioner’s and Dr. Buller’s interpretation of the term “attached” is not the
`
`broadest reasonable interpretation. (See Reply at 19-23.)
`
`Observation #35. In Exhibit 2094, on page 76 line 7 through page 78 line 5,
`
`Dr. Buller testified that two pieces welded together are not “attached,” but two
`
`pieces sutured together are “attached.” This testimony is relevant to whether there
`
`is a nexus between the claimed invention and the secondary considerations of
`
`non-obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that
`
`Petitioner’s and Dr. Buller’s interpretation of the term “attached” is not the
`
`broadest reasonable interpretation. (See Paper 34 at 19-23.)
`
`Observation #36. In Exhibit 2094, on page 78 line 6 through page 79 line 1,
`
`Dr. Buller testified that he could not determine whether two pieces glued together
`
`would be “attached.” This testimony is relevant to whether there is a nexus
`
`between the claimed invention and the secondary considerations of
`
`non-obviousness regarding the SAPIEN 3 and, in particular, to demonstrate that
`
`Petitioner’s and Dr. Buller’s interpretation of the term “attached” is not the
`
`broadest reasonable interpretation. (See Paper 34 at 19-23.)
`
`Observation #37. In Exhibit 2094, on page 79 line 15 through page 82
`
`line 18, Dr. Buller testified that the SAPIEN 3 includes a piece of fabric that is
`
`sutured around the frame and supports the commissures of the leaflets. This
`
`-14-
`
`

`

`testimony is relevant to whether there is a nexus between the claimed invention
`
`and the secondary considerations of non-obviousness regarding the SAPIEN 3 and,
`
`in particular, to disprove Petitioner’s contention (Paper 34 at 17-22) and
`
`Dr. Buller’s opinion (Ex. 1045 ¶ 16) that the SAPIEN 3 does not include “a
`
`replacement valve commissure support element attached to the expandable
`
`anchor.”
`
`Dated: November 3, 2017
`
`Respectfully submitted,
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu (Reg. No. 45,380)
`ARNOLD & PORTER
`KAYE SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax:
`(213) 243-4199
`
`Attorneys for Patent Owner Boston
`Scientific Scimed, Inc.
`
`-15-
`
`

`

`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`MOTION FOR OBSERVATIONS ON CROSS-EXAMINATION was served on
`November 3, 2017 to the following Counsel for Petitioner via e-mail:
`
`Gregory S. Cordrey (Reg. No. 44,089)
`Jeffer Mangels Butler & Mitchell, LLP
`3 Park Plaza, Suite 1100
`Irvine, CA 926214
`Email: gcordrey@jmbm.com
`Telephone: 949-623-7200
`Facsimile: 949-623-7201
`
`Brian Egan (Reg. No. 54,866)
`Morris, Nichols, Arsht & Tunnell, LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`Email: began@MNAT.com
`Telephone: 302-351-9454
`Facsimile: 302-498-6216
`
`Catherine Nyarardy (Reg. No. 42,042)
`Paul, Weiss, Rifkind, Wharton &
`Garrison, LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Email: cnyarardy@paulweiss.com
`Telephone: 212-373-3532
`Facsimile: 212-492-0532
`
`Attorneys for Petitioners Edwards LifeSciences Corporation, Edwards Lifesciences
`LLC, and Edwards Lifesciences AG
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`ARNOLD & PORTER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`-i-
`
`

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