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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`and PFIZER, INC.,
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`Petitioners,
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`v.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
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`Patent Owner
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`Case No. IPR2018-016751
`U.S. Patent No. 8,603,044
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`PATENT OWNER’S RESPONSES TO PETITIONERS’ OBSERVATIONS
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`1 Pfizer Inc., who filed a petition in IPR2019-00977, has been joined as petitioner
`in this proceeding.
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`1. The testimony cited by Petitioner does not concern Dr. Slocum’s pen injector
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`experience in 2003. Regardless, whether Dr. Slocum had pen injector experience in
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`2003 is irrelevant. Rowe Price Investment Servs., Inc. v. Secure Access, LLC, Case
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`CBM2015-00027, slip op. at 21–22 (PTAB June 13, 2016) (Paper 31). Dr. Slocum
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`was knowledgeable about pen injectors as of 2019, when he submitted his
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`declaration. EX2107, ¶¶ 25-61. Furthermore, both Dr. Slocum and Mr. Leinsing
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`agree that a person having ordinary skill in the art (“POSA”) does not require pen
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`injector experience; and, in the corresponding district court litigation where both
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`experts applied the same definitions for the level of ordinary skill as in this IPR, the
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`district court accepted Dr. Slocum as qualified expert. EX1011 ¶106, EX2107 ¶102.
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`2. Petitioners mischaracterize Dr. Slocum’s testimony. Dr. Slocum did not testify
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`that Steenfeldt-Jensen includes an express suggestion to provide a threaded driver
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`tube. Furthermore, Petitioners cite only a portion of Dr. Slocum’s testimony
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`explaining Steenfeldt-Jensen at column 7, lines 44-47. Dr. Slocum also testified that
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`a POSA would understand that having a nut element rotated by a driver tube would
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`not be a good idea. See EX1115, 526:13-25. This testimony is relevant to whether a
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`POSA would have been motivated to modify Steenfeldt-Jensen in view of itself.
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`3. Petitioners’ description of the cited testimony is incorrect. The cited testimony
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`does not address what Steenfeldt-Jensen proposes or whether a POSA would have
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`been able to accomplish a modification. Regardless, Dr. Slocum did not testify that
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`1
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`Steenfeldt-Jensen expressly proposes an embodiment where the driver tube has an
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`internal thread instead of a slot, and wall 4 has a slot instead of a thread.
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`4. Petitioners cite only a portion of Dr. Slocum’s testimony comparing the first and
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`fifth embodiments. Dr. Slocum also testified that the drive mechanisms and force
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`chains for the dose dialing operation are very different, in part because friction is
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`desirable in the drive mechanism of the first embodiment but not in the fifth
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`embodiment. See EX1115, 475:5-476:20. This testimony is relevant to whether
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`Steenfeldt-Jensen at column 7, lines 44-47, applies to the fifth embodiment, because
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`it shows that the first and fifth embodiments significantly differ.
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`5. Petitioners mischaracterize the cited testimony. Dr. Slocum testified that claim 6
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`of Steenfeldt-Jensen describes a threaded driving member—not a threaded driver
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`tube. Moreover, the cited testimony is not relevant, because neither the Petition nor
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`the Reply point to or otherwise rely on Steenfeldt-Jensen’s claim 6 for any
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`obviousness grounds. Furthermore, Dr. Slocum also testified that claim 6 does not
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`disclose a pen injector having a dose dial sleeve with a threaded engagement to a
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`housing, a sleeve releasably connected to a dose dial sleeve, or a clutch. See EX1115,
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`597:6-598:14. This testimony is relevant to whether the pen injector disclosed by
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`Steenfeldt-Jensen’s claim 6 renders the challenged claims obvious, because each of
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`the challenged claims requires at least (i) a dose indicator/dose dial sleeve with a
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`threaded engagement to a housing and (ii) a releasably connected sleeve/clutch.
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`2
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`6. Petitioners mischaracterize the cited testimony. The cited testimony only reflects
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`that Dr. Slocum obtained the dimensions of the FlexPen and the coefficient of
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`friction from Mr. Veasey to use in his spreadsheet. See further EX1114, 462:4-
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`463:12. The record does not show that Mr. Veasey’s measurements are unreliable.
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`Petitioners further mischaracterize the relevance of this testimony. Dr. Slocum does
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`not lack relevant knowledge of the field. Dr. Slocum researched the prior art patents,
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`conversed with those in the industry, and he canvassed the literature on pre-critical
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`date pen injectors, design considerations, and design standards to put himself in the
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`shoes of a POSA working on pen injectors in early 2003. See, e.g., EX2107 ¶¶ 25-
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`61. Only then did he personally design a computational model that informed his
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`opinions. Mr. Leinsing also created a computational model, but he deleted it and did
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`not submit it in the district court proceeding or this proceeding. EX2227, 341:17-22.
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`7. Petitioners again mischaracterize the cited testimony. Dr. Slocum testified that
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`Mr. Veasey measured a coefficient of friction of 0.15 in the commercially available
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`product but recommended using 0.1 for “super lubricious” plastics in a pen injector.
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`Furthermore, Petitioners cite only a portion of Dr. Slocum’s testimony discussing
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`the measurements obtained from Mr. Veasey. Dr. Slocum also testified that 0.1 is
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`very good for plastics. See EX1114, 463:1-12.
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`8. Petitioners mischaracterize the relevance of the cited testimony. The numbers Dr.
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`Slocum used in his spreadsheet are not flawed, and there is no evidence in the record
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`3
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`showing that the numbers are flawed. Instead, these numbers came from undisputed
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`measurements of a publicly-available product. See EX1114, 462:4-463:12.
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`9. The testimony cited by Petitioners is taken out of context. Dr. Slocum was asked
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`about a single sentence in a document specifying a coefficient of friction range of
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`0.05 to 0.1 for certain sliding contact bearings. Dr. Slocum was not asked whether
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`the bearings discussed in the single sentence were suitable for pen injectors. Nor was
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`he asked about the portion of the document explaining that coefficients of friction
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`between 0.05 and 0.1 are for active lubrication environments (e.g., those requiring
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`motorized lubrication pumps). Nor was Dr. Slocum asked about a portion of the
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`document describing a typical coefficient of friction for sliding contact plastic
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`bearings as being 0.2. Regardless, Dr. Slocum testified that, in his personal
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`experience, 0.1 is a “very good” coefficient of friction for a plastic. EX1114, 463:5-
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`12. Indeed, this is a better coefficient of friction than what was seen in the
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`commercialized Steenfeld-Jensen product – compare 0.1 with 0.15 in the
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`commercialized product. Furthermore, Dr. Slocum also testified that using a lower
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`coefficient of friction (e.g., .08) does not resolve the problems with the proposed
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`modification. See EX1114, 463:9-21.
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`10. In the cited testimony, Dr. Slocum explains that taking into account the points of
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`reduced friction would only change the 51% calculation by a few percentage points.
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`See EX1115, 562:20-25.
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`4
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`11. Petitioners mischaracterize Dr. Slocum’s testimony. He testified that the 844
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`Patent figures show only one embodiment, not that the 844 Patent specification has
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`only one embodiment. See EX1115, 576:21-577:16. Petitioners also omit the
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`portions of Dr. Slocum’s testimony that describe the state of the art for internally-
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`threaded piston rods. Dr. Slocum testified that leadscrew drive mechanisms were
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`well understood and centuries old (see EX1115, 497:2-498:21), and that the
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`examples of internally threaded piston rods he identified are drug delivery devices
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`and relevant to pen injectors (see EX1115, 498:22-501:3).
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`12. Dr. Slocum testified that he did not rely on any pre-2003 documents showing
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`injection force was the sole motivating factor in injector-pen design. This testimony,
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`however, does not show that Dr. Slocum’s opinions regarding design considerations
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`are based only on post-2003 statements. See, e.g., EX2107, ¶¶ 25-61. Moreover,
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`Mr. Leinsing conceded that injection force was an important design consideration.
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`EX2163, 80:17-81:5.
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`13. Petitioners mischaracterize Dr. Slocum’s testimony. Dr. Slocum testified that the
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`Next Generation FlexPen (NGFP) was released with low injection force as compared
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`to the FlexPen. Ex. 1115, 592:9-21. Dr. Slocum did not testify that the NGFP had a
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`comparable injection force with the SoloSTAR product. Indeed, the SoloSTAR
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`product had a significantly lower injection force as compared to the NGFP. See
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`EX2100.003, .006.
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`5
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`Dated: December 27, 2019
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`Respectfully submitted,
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`Reg. No. 55,721
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`Phone: 212-310-8000
`elizabeth.weiswasser@weil.com
`
`Counsel for Patent Owner
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`6
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on December 27, 2019, the foregoing
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`PATENT OWNER’S RESPONSES TO PETITIONERS’ OBSERVATIONS
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`was served via electronic mail, upon the following:
`
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`Richard Torczon
`Wesley Derryberry
`Tasha Thomas
`Lora Green
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, 5th Floor
`Washington, D.C. 20006
`rtorczon@wsgr.com
`wderryberry@wsgr.com
`tthomas@wsgr.com
`lgreen@wsgr.com
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`Douglas H. Carsten
`Jeffrey W. Guise
`Arthur Dykhuis
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`dcarsten@wsgr.com
`jguise@wsgr.com
`adykhuis@wsgr.com
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`Lorelei Westin
`WILSON SONSINI GOODRICH & ROSATI
`650 Page Mill Road
`Palo Alto, CA 94304
`lwestin@wsgr.com
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`Nicole W. Stafford
`WILSON SONSINI GOODRICH & ROSATI
`900 South Capital of Texas Highway
`Las Cimas, IV Fifth Floor
`Austin, TX 78746
`nstafford@wsgr.com
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`Elham F. Steiner (Pro Hac Vice)
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`San Diego CA 92130
`esteiner@wsgr.com
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`Jad Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`jmills@wsgr.com
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`Jovial Wong
`WINSTON & STRAWN LLP
`1700 K Street, NW
`Washington, D.C. 20006
`jwong@winston.com
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`
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`/Emily Davis/
`Emily Davis
`IP Paralegal
`Weil, Gotshal & Manges LLP
`2001 M Street, NW, Suite 600
`Washington, DC 20036
`emily.davis@weil.com
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