IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`PARTIES’ CONSOLIDATED ONE PAGE SUBMISSIONS &
`JOINT NOTICE OF SUPPLEMENTAL AUTHORITY
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`

`Parties’ Consolidated Submission: USPN 7,326,708
`
`Pursuant to a joint request via email to the Board on March 26, 2020, and an
`
`Order from the Board of the same date, Petitioner Mylan Pharmaceuticals Inc. and
`
`Patent Owner Merck Sharp & Dohme Corp. hereby submit their Consolidated One
`
`Page Submission and the Joint Notice of Supplemental Authority concerning:
`
` Advanced Bionics, LLC v. MED-EL Alektromedizinische Gerate
`GmbH, IPR2019-01469, Paper 6 (P.T.A.B. Feb. 13, 2020) (designated
`precedential March 24, 2020) (Appendix C);
`
` Oticon Medical AB v. Cochlear Limited, IPR2019-00975, Paper 15
`(P.T.A.B. Oct. 16, 2019) (designated precedential March 24, 2020)
`(Appendix D); and
`
` PUMA North America v. Nike Inc., IPR2019-01042, Paper 10
`(P.T.A.B. Oct. 31, 2019) (designated informative March 24, 2020)
`(Appendix E).
`
`Petitioner and Patent Owner also provide as Appendix A and Appendix B,
`
`respectively, a one-page statement explaining the import of these cases on their
`
`respective arguments concerning discretionary denial of institution under 35
`
`U.S.C. §§ 314(a) and/or 325(d).
`
`Date: March 30, 2020
`
` Respectfully submitted,
`
`/s Jitendra Malik/
`Jitendra Malik, Ph.D. (Reg. No. 55,823)
`Alissa M. Pacchioli (Reg. No. 74,252)
`Christopher W. West, Ph.D.
`(Reg. No. 74,724)
`
`/s Stanley E. Fisher /
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`Jessamyn S. Berniker (Reg. No. 72,328)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`ii
`
`

`

`Parties’ Consolidated Submission: USPN 7,326,708
`
`Heike S. Radeke, Ph.D.
`(Reg. No. 75,394)
`KATTEN MUCHIN ROSENMAN
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@katten.com
`alissa.pacchioli@katten.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`sfisher@wc.com
`bgenderson@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`iii
`
`

`

`Parties’ Consolidated Submission: USPN 7,326,708
`
`Appendix A
`
`Petitioner Mylan Pharmaceuticals Inc.’s One Page Submission
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S ONE PAGE
`SUBMISSION
`
`

`

`Bionics emphasizes express consideration by the Examiner for 325(d) denial.
`
`Bionics at 10 ((a) and (b): “art evaluated during examination.”); id. ((d): “arguments
`
`made during examination”); id. ((c): “record developed by the Office”). Bionics’
`
`detailed discussion of the prosecution history showed the degree to which there was
`
`express consideration by the Examiner. Id. at 11-13, 15. “Factors (c), (e), and (f)
`
`relate to whether the Petitioner has demonstrated a material error by the Office.” Id.
`
`at 10. Mylan has “show[n] the Office erred by overlooking something persuasive,”
`
`(id.) because there is no evidence (other than speculation) that the arguments
`
`provided in Mylan’s Petition were ever expressly considered by the Office. Oticon
`
`and Puma also emphasize express consideration by the Examiner for 325(d) denial.
`
`Oticon at 18-19; Puma at 21. Bionics, Oticon, and Puma never dealt with the
`
`situation where there were no prior art rejections during examination. Petition, 10.
`
`Oticon instituted that IPR and does not support a 314(a) denial. Like here, in
`
`Oticon the concurrent litigation wasn’t stayed. Oticon at 23. Unlike Oticon, because
`
`of the early filing, Mylan did not use Merck’s “responses to Petitioner’s invalidity
`
`arguments and contentions . . . as a roadmap.” Oticon at 22; Petition, 67; EX1015,
`
`p.15-16. Merck does not contend otherwise. PORP, 31. Further, NHK’s requirement
`
`that the timing of the FWD overlaps with the scheduled District Court trial was not
`
`changed by Oticon. Oticon at 22-24. NHK also is a precedential decision. The
`
`FWD is due 5 months before any scheduled trial. POPR, 26. /s Jitendra Malik/
`
`

`

`Parties’ Consolidated Submission: USPN 7,326,708
`
`Appendix B
`
`Patent Owner Merck Sharp & Dohme Corp.’s One Page
`Submission
`
`

`

`Patent Owner Merck Sharp & Dohme Corp.’s One Page Submission
`
`The Board should deny institution. Under Advanced Bionics, the Board must
`
`consider “whether the same or substantially the same art . . . [or] arguments previ-
`
`ously were presented,” and if so, Petitioner must demonstrate that “the Office erred
`
`in a manner material to the patentability of the challenged claims.” App’x C at 8–
`
`10. “If reasonable minds can disagree regarding the [Office’s] purported treatment
`
`. . . it cannot be said that the Office erred in a manner material to patentability.” Id.
`
`at 10. A rejection is not required: where “the record of the Office’s previous con-
`
`sideration of the art [may be] not well developed or silent,” Petitioner must establish
`
`that “the Office erred by overlooking something persuasive,” App’x C at 10–11.
`
`Here, Mylan has not carried its burden. The primary references were “previously
`
`presented” in an IDS and the patent itself distinguishes WO ’498. There is no ma-
`
`terial error; the Examiner could reasonably have agreed with that distinction.
`
`Mylan’s expert raises nothing new and fails to address adequately the 1:1 stoichi-
`
`ometry, see App’x E at 15 (no material error where failure to address motivation).
`
`Oticon is distinguishable in that the key prior art (Choi) was “not previously
`
`of record” in an IDS or the specification. App’x D at 10. Moreover, the Oticon
`
`IPR “would not be directly duplicative of the District Court consideration of valid-
`
`ity” and no trial date had been set. Id. at 23. Not true here. Mylan’s grounds are a
`
`subset of the MDL invalidity contentions based on the same art, the grounds do not
`
`extend to a majority of the asserted claims, and trial dates are set in DE and WV.
`
`

`

`Patent Owner Merck Sharp & Dohme Corp.’s One Page Submission
`
`Date: March 30, 2020
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`Jessamyn S. Berniker (Reg. No. 72,328)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`

`

`Appendix C
`
`Advanced Bionics, LLC Decision
`
`

`

`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`
`Paper No. 6
`Entered: February 13, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ADVANCED BIONICS, LLC,
`Petitioner,
`
`v.
`
`MED-EL ELEKTROMEDIZINISCHE GERÄTE GMBH,
`Patent Owner.
`_______________
`
`IPR2019-01469
`Patent 8,634,909 B2
`_______________
`
`
`
`Before WILLIAM M. FINK, Vice Chief Administrative Patent Judge,
`LINDA E. HORNER and KALYAN K. DESHPANDE, Administrative
`Patent Judges.
`
`
`DESHPANDE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`
`I. INTRODUCTION
`Advanced Bionics, LLC (“Petitioner”) filed a Petition requesting an
`inter partes review of claims 1, 3, 5, 6, 10, 11, 14, 16, and 20 of U.S. Patent
`No. 8,634,909 (Ex. 1001, “the ’909 patent”). Paper 1 (“Pet.”). MED-EL
`Elektromedizinische Geräte GmbH (“Patent Owner”) filed a Preliminary
`Response. Paper 5 (“Prelim. Resp.”). We have authority under 35 U.S.C.
`§ 314(a), which provides that an inter partes review may not be instituted
`“unless . . . there is a reasonable likelihood that the petitioner would prevail
`with respect to at least 1 of the claims challenged in the petition.” After
`considering the Petition, Patent Owner’s Preliminary Response, and
`associated evidence, we exercise our discretion to deny institution of inter
`partes review under 35 U.S.C. § 325(d).
`Related Matters
`
`Petitioner and Patent Owner indicate that the ’909 patent is the subject
`of MED-EL Elektromedizinische Geräte Ges.m.b.H et al. v. Advanced
`Bionics LLC, Case No. 1:18-cv-01530-MN (D. Del), filed on October 3,
`2018. Pet. 89; Paper 4.
`
`The ’909 Patent
`
`The ’909 patent relates to “implantable medical devices, and
`specifically, to magnetic elements in such devices that allow for magnetic
`resonance imaging.” Ex. 1001, 1:9–11. The ’909 patent discloses that a
`typical cochlear hearing implant system includes an external magnet having
`a conventional coin shape and a north-south magnetic dipole perpendicular
`to the skin as well as an internal magnet having a coin shape and a north-
`south magnetic dipole perpendicular to the skin. Id. at 1:14–22, 1:26–29.
`According to the ’909 patent, interactions occur between the implant magnet
`
`2
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`and an applied external magnetic field when a patient undergoes Magnetic
`Resonance Imaging (MRI) examination. Id. at 1:38–41. Such interactions
`may displace the internal magnet or displace the internal implant housing,
`which may damage adjacent tissue; reduce or remove the magnetization of
`the internal magnet; or cause imaging artifacts in the MRI image. Id. at
`1:43–53.
`The ’909 patent discloses a magnetic arrangement for an implantable
`system that includes a planar coil housing containing a signal coil. Id. at
`2:14–18. The magnetic arrangement further includes a first attachment
`magnet located within the plane of the coil housing so the first attachment
`magnet is rotatable therein and has a magnetic dipole parallel to the plane of
`the coil housing. Id. at 2:18–22. A side cross-sectional view of cochlear
`implant 400 is shown in Figure 4(B):
`
`
`Figure 4(B) illustrates that cochlear implant 400 has planar coil
`housing 402 and first attachment magnet 401 located within the plane of coil
`housing 402 and rotatable therein. Id. at 3:65–4:3. First attachment magnet
`401 also has a magnetization direction with a magnetic dipole parallel to the
`plane of coil housing 402. Id. at 4:4–5. External transmitter coil housing
`
`3
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`405 has second attachment magnet 404 with a similar magnetic dipole
`parallel to the plane of coil housing 405. Id. at 4:5–8. According to the ’909
`patent, the magnets may be disk shaped but “any shape could be
`implemented so long as the magnetization is parallel to the coil housing and
`the skin.” Id. at 6:3–6. The ’909 patent also discloses that disk-shape
`magnets allow for rotation in only one plane but still can align well with the
`field of a magnetic resonance scanner without the need to drill a recess into
`the bone during implantation, which spherical magnets may require. Id. at
`1:66–2:7, 6:45–50, 6:66–7:2.
`The ’909 patent discloses that the arrangement of Figure 4(B) results
`in attachment magnets 401, 404 self-orienting when external transmitter coil
`housing 405 is placed on the skin of a patient. Id. at 4:5–12. In addition,
`when a patient with the arrangement of Figure 4(B) undergoes an MRI, a
`magnetization component of the internal attachment magnet is perpendicular
`to the external magnetic field of magnetic resonance scanner. Id. at 4:19–25.
`This causes the attachment magnet to turn around its axis to align with the
`magnetization direction of the magnetic resonance scanner, which results in
`no torque on the magnet and its coil housing or weakening of the magnetic
`force of the attachment magnet. Id. at 4:25–28, 4:35–39.
`Illustrative Claim
`
`Petitioner challenges claims 1, 3, 5, 6, 10, 11, 14, 16, and 20 of the
`’909 patent. Pet. 25–87. Claims 1 and 10 are the only independent claims
`challenged. Claim 1 is illustrative of the challenged claims and is
`reproduced below:
`1.
`An implantable system for a recipient patient, the
`implantable system comprising:
`
`4
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`
`a coil housing configured to be implanted under the
`patient’s skin, the coil housing having a planar outer surface
`configured to lie parallel to the patient’s skin and containing a
`signal coil for transcutaneous communication of an implant
`communication signal; and
`a planar disc shaped first attachment magnet within the
`coil housing, the first attachment magnet adapted to be rotatable
`therein, having a magnetic dipole moment oriented across a
`diameter of the first attachment magnet, and configured within
`the coil housing such that the magnetic dipole moment remains
`substantially parallel to the planar outer surface of the coil
`housing when the first attachment magnet rotates for
`transcutaneous magnetic interaction with a corresponding
`second attachment magnet.
`Ex. 1001, 7:44–60. Independent claim 10 is similar to claim 1 and further
`recites a transmitter housing containing a second attachment magnet. Id. at
`8:27‒47.
`
`5
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`
`
`
`The Alleged Grounds of Unpatentability and Evidence of Record
`
`The information presented in the Petition sets forth proposed grounds
`of unpatentability of claims 1, 3, 5, 6, 10, 11, 14, 16, and 20 of the ’909
`patent under 35 U.S.C. § 103(a)1 as follows (see Pet. 25–87):2
`
`Claim(s) Challenged
`
`35 U.S.C. § Reference(s)/Basis
`
`1, 3, 5, 6, 10, 11, 14, 16,
`20
`1, 3, 5, 6, 10, 11, 14, 16,
`20
`
`103(a)
`
`103(a)
`
`Zimmerling,3 Charvin4
`Chang,5 Zimmerling,
`Schmid6
`
`II. ANALYSIS
`35 U.S.C. § 325(d)
`
`Petitioner and Patent Owner present arguments about our discretion
`under 35 U.S.C. § 325(d). Pet. 87–89; Prelim. Resp. 65–72. We address
`this threshold issue first, and, determine that it is dispositive of our decision
`of whether to institute inter partes review. For the foregoing reasons, we are
`
`
`1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103 effective March 16,
`2013. Because the application from which the ’909 patent issued was filed
`before March 16, 2013, we refer to the pre-AIA version of § 103.
`2 Petitioner supports its challenge with the Declaration of Frank G. Shellock,
`Ph.D. Ex. 1002.
`3 U.S. Pat. No. 6,838,963 B2, issued Jan. 4, 2005 (“Zimmerling,” Ex. 1003).
`4 U.S. Pat. No. 7,266,208 B2, issued Sept. 4, 2007 (“Charvin,” Ex. 1004).
`5 U.S. Pat. App. Pub. No. US 2009/0005836, published Jan. 1, 2009
`(“Chang,” Ex. 1005).
`6 U.S. Pat. No. 6,761,681 B2, issued July 13, 2004 (“Schmid,” Ex. 1006).
`
`6
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`persuaded by Patent Owner to exercise our discretion to deny institution of
`inter partes review under 35 U.S.C. § 325(d).
`Introduction
`1.
`Section 325(d) provides that the Director may elect not to institute7 a
`proceeding if the challenge to the patent is based on matters previously
`presented to the Office. 35 U.S.C. § 325(d) states, in pertinent part,
`In determining whether to institute or order a proceeding under
`this chapter, chapter 30, or chapter 31, the Director may take
`into account whether, and reject the petition or request because,
`the same or substantially the same prior art or arguments
`previously were presented to the Office.
`Thus, 35 U.S.C. § 325(d) identifies two separate issues for the
`Director to consider in exercising discretion to deny institution of review:
`whether the petition presents to the Office the same or substantially the same
`art previously presented to the Office, or whether the petition presents to the
`Office the same or substantially the same arguments previously presented to
`the Office. As discussed in detail below, the question of whether proffered
`art or arguments are “the same or substantially the same” as art or arguments
`previously presented to the Office is a highly factual inquiry, which may be
`resolved by reference to the factors set forth in Becton, Dickinson.8
`Under § 325(d), the art and arguments must have been previously
`presented to the Office during proceedings pertaining to the challenged
`patent. Previously presented art includes art made of record by the
`
`
`7 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a).
`8 Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586,
`Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)
`(“Becton, Dickinson”).
`
`7
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`Examiner, and art provided to the Office by an applicant, such as on an
`Information Disclosure Statement (IDS), in the prosecution history of the
`challenged patent. The proceedings in which the art was previously
`presented include, for example: examination of the underlying patent
`application, reexamination of the challenged patent, a reissue application for
`the challenged patent, and AIA post-grant proceedings involving the
`challenged patent.
`If the “same or substantially the same prior art or arguments
`previously were presented to the Office,” then the Board’s decisions
`generally have required a showing that the Office erred in evaluating the art
`or arguments. See, e.g., Becton, Dickinson, Paper 8 at 24 (considering
`whether the petitioner has pointed out sufficiently how the examiner erred in
`its evaluation of the asserted prior art). If the petitioner fails to show that the
`Office erred, the Director may exercise his discretion not to institute inter
`partes review. Id. (exercising discretion where “Petitioner has not pointed to
`error by the Examiner”).
`Thus, under § 325(d), the Board uses the following two-part
`framework: (1) whether the same or substantially the same art previously
`was presented to the Office or whether the same or substantially the same
`arguments previously were presented to the Office; and (2) if either
`condition of first part of the framework is satisfied, whether the petitioner
`has demonstrated that the Office erred in a manner material to the
`patentability of challenged claims.9 If a condition in the first part of the
`
`
`9 An example of a material error may include misapprehending or
`overlooking specific teachings of the relevant prior art where those teachings
`impact patentability of the challenged claims. Another example may include
`8
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`framework is satisfied and the petitioner fails to make a showing of material
`error, the Director generally will exercise discretion not to institute inter
`partes review. If reasonable minds can disagree regarding the purported
`treatment of the art or arguments, it cannot be said that the Office erred in a
`manner material to patentability. At bottom, this framework reflects a
`commitment to defer to previous Office evaluations of the evidence of
`record unless material error is shown.
`Becton, Dickinson Factors
`2.
`We recognize that restating the framework in its statutory language
`does not address challenging factual questions, such as when a ground of
`unpatentability presents “substantially the same prior art or arguments”
`previously presented to the Office. In this regard, the Becton, Dickinson
`factors10 provide useful insight into how to apply the framework under
`35 U.S.C. § 325(d). Becton, Dickinson specifically addressed the situation
`in which the petition relied on the same or substantially the same art or
`
`
`an error of law, such as misconstruing a claim term, where the construction
`impacts patentability of the challenged claims.
`10 Becton, Dickinson identifies the following non-exclusive factors: (a) the
`similarities and material differences between the asserted art and the prior art
`involved during examination; (b) the cumulative nature of the asserted art
`and the prior art evaluated during examination; (c) the extent to which the
`asserted art was evaluated during examination, including whether the prior
`art was the basis for rejection; (d) the extent of the overlap between the
`arguments made during examination and the manner in which petitioner
`relies on the prior art; (e) whether petitioner has pointed out sufficiently how
`the examiner erred in its evaluation of the asserted prior art; and (f) the
`extent to which additional evidence and facts presented in the petition
`warrant reconsideration of the prior art or arguments. See Becton, Dickson,
`Paper 8 at 17–18 (§ III.C.5, first paragraph).
`
`9
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`arguments previously presented during initial examination of the challenged
`patent. The factors set forth in Becton, Dickinson should be read broadly,
`however, to apply to any situation in which a petition relies on the same or
`substantially the same art or arguments previously presented to the Office
`during a proceeding pertaining to the challenged patent. For example,
`although Becton, Dickinson factors (a) and (b) pertain to art evaluated
`“during examination,” these factors more broadly provide guidance as to
`whether the art presented in the petition is the “same or substantially the
`same” as the prior art previously presented to the Office during any
`proceeding, including prior AIA proceedings. Similarly, although Becton,
`Dickinson factor (d) pertains to arguments made “during examination,” this
`factor more broadly provides guidance as to whether the arguments
`presented in the petition are “the same or substantially the same” as the
`arguments previously presented to the Office during any proceeding.
`If, after review of factors (a), (b), and (d), it is determined that the
`same or substantially the same art or arguments previously were presented to
`the Office, then factors (c), (e), and (f) relate to whether the petitioner has
`demonstrated a material error by the Office. Factor (c) focuses on the record
`developed by the Office in previously reviewing the art or arguments. It
`informs, therefore, the petitioner’s showing under factors (e) and (f), which
`focus on the petitioner’s evidence of previous Office error regardless of the
`context in which the same or substantially the same art or arguments were
`previously presented. For example, if the record of the Office’s previous
`consideration of the art is not well developed or silent, then a petitioner may
`show the Office erred by overlooking something persuasive under factors (e)
`and (f). On the other hand, if the alleged error is a disagreement with a
`
`10
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`specific finding of record by the Office, then ordinarily the petitioner’s
`required showing of material error must overcome persuasively that specific
`finding of record. That is, although Becton, Dickinson factor (c) evaluates
`“the extent to which the asserted art was evaluated during examination,
`including whether the prior art was the basis for rejection,” the focus should
`be on the record when determining whether the Office erred in evaluating
`such art or arguments.
`Application of § 325(d) to the Current Facts
`3.
`Petitioner argues that we should exercise our discretion to institute
`inter partes review because evaluation of “[t]he Becton[,] Dickinson factors
`all weigh in favor of institution under 35 U.S.C. § 325(d).” Pet. 87. Patent
`Owner contends that we should exercise our discretion to deny institution of
`inter partes review because the “prior art relied on by Petitioner was
`previously considered and distinguished during prosecution of the ‘909
`Patent and the arguments presented by Petitioner add nothing new from what
`was already known and considered by the Examiner during prosecution.”
`Prelim. Resp. 65. We apply the framework set forth above to the facts of the
`current proceeding to determine whether to exercise our discretion to
`institute or deny institution of inter partes review.
`a. Prosecution history of the ’909 patent
`U.S. Patent Application No. 13/091,352 (“the ’352 application”),
`which claims priority to U.S. Provisional Application No. 61/327,158,
`issued as the ’909 patent. Ex. 1001, codes (10), (21), (60); Pet. 17. The
`’352 application included original independent claim 1, and dependent
`claims 2–17. Ex. 1007, 17–19. The Examiner rejected original claims 1–3
`
`11
`
`

`

`IPR2019-01469
`Patent 8,634,909 B2
`
`and 5–17 as anticipated by Zimmerling,11,12 and rejected original claim 4 as
`obvious over Zimmerling, relying predominantly on Figures 8A–8C and the
`description of Figures 8A–8C. Id. at 60–62.
`The Applicant then amended original independent claim 1 to require
`that the planar coil housing have “parallel flat planar outer surfaces lying in
`the plane of the patient’s skin,” and argued the spherical magnet
`embodiment of Zimmerling did not meet this limitation because “one side of
`the implant housing must substantially protrude out from the main body of
`the implant housing.” Ex. 1007, 71, 75. The Examiner rejected amended
`claim 1 and dependent claims 2, 3, and 5–17 as anticipated by Zimmerling,
`and dependent claim 4 as obvious over Zimmerling, relying again on Figures
`8A–8C and the description of these figures, and further on Figure 9. Id. at
`82–86. The Examiner found that “an external magnetic field is applied by
`laying another magnet over [the internal] magnet” and determined that
`Applicant’s argument that Zimmerling would cause a protrusion in the
`patient’s skin is unpersuasive because there is “nothing in the disclosure of
`Zimmerman [sic] to suggest that a spherical or other configuration of [the]
`magnet would cause a protrusion to appear in the patient’s skin.” Id. at 82–
`83.
`
`The Applicant then further amended claim 1 to require the “coil
`housing configured to be implanted under the patient’s skin” that has “a
`
`11 The Examiner found that Zimmerling is prior art under 35 U.S.C.
`§ 102(b). Ex. 1007, 60.
`12 Dr. Martin Zimmerling is the first named inventor of both the ’909 patent
`and the submitted Zimmerling reference. Prelim. Resp. 2. Additionally,
`both the ’909 patent and Zimmerling list MED-EL Elektromedizinische
`Geräte GmbH as the assignee. See Ex. 1001, code (73); Ex. 1003, code (73).
`
`12
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`planar outer surface configured to lie parallel to the patient’s skin.” Id. at
`95. Claim 1 was also amended to require that the first attachment magnet
`has a magnetic dipole “moment oriented across a diameter of the first
`attachment magnet, and configured within the coil housing such that the
`magnetic dipole moment remains substantially parallel to the planar outer
`surface.” Id. The Applicant argued that amended claim 1 requires that “an
`implantable magnet that remains substantially parallel to an outer planar
`surface of its housing (and thus also to the patient’s skin) when the magnet
`rotates within the housing,” whereas Zimmerling discloses a magnet whose
`moment “does not remain substantially parallel to the outer surface of the
`housing when the magnet rotates.” Id. at 101.
`The Examiner then allowed the claims, including independent claims
`1 and 10, noting that the claims are “allowable over the prior art for the
`reasons argued by the Applicant.” Id. at 117–118.
`b. Whether the same or substantially the same art previously
`was presented to the Office
`In Ground 1, Petitioner relies on the combination of Zimmerling and
`Charvin. Pet. 26. In Ground 2, Petitioner relies on the combination of
`Chang, Zimmerling, and Schmid. Id. As discussed above, the Examiner
`rejected original claims 1–3 and 5–17 as anticipated by Zimmerling, and
`original claim 4 as obvious over Zimmerling. See Section II.A.3.a.
`Petitioner and Patent Owner agree that Zimmerling was discussed during
`prosecution. Pet. 88; Prelim. Resp. 66. Accordingly, it is not disputed that
`Zimmerling is the same art previously presented to the Office.
`Petitioner and Patent Owner agree that Charvin, Chang, and Schmid
`were not were not of record during prosecution. Pet. 87; Prelim. Resp. 70.
`
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`Thus, neither Charvin, nor Chang, nor Schmid is the “same” art previously
`presented to the Office.
`Patent Owner asserts that each of Charvin, Chang, and Schmid is
`“substantially the same” as Zimmerling. Prelim. Resp. 70. Petitioner
`argues, however, that the Examiner did not cite Zimmerling for the same
`purposes as Petitioner relies on Charvin and Schmid. Pet. 87. Petitioner
`also asserts that both grounds of unpatentability alleged in the Petition
`combine Zimmerling with references not before the Examiner to create a
`distinct combination not considered by the Examiner, and both grounds rely,
`at least in part, on Zimmerling as a secondary reference. Id. at 88.
`Beginning with Ground 1, Petitioner alleges that Zimmerling
`discloses all of the limitations of independent claim 113 except for the
`limitations “a planar disc shaped first attachment magnet within the coil
`housing” and “the magnetic dipole moment remains substantially parallel to
`the planar outer surface of the coil housing when the first attachment magnet
`rotates.” Pet. 27‒61. Petitioner alleges that Charvin alone discloses these
`two limitations. Id. at 44–46, 48–49.14
`
`
`13 Petitioner alleges Zimmerling discloses all of the limitations of
`independent claims 1 and 10, and dependent claims 3, 5, 6, 10, and 20.
`Pet. 25–61. We recognize that Petitioner does not allege that Zimmerling
`alone discloses the additional limitations of claims 11, 14, and 16. Id.
`14 In addition to alleging that Charvin discloses these two limitations,
`Petitioner often supplements its citations to Zimmerling with additional
`citations to Charvin, asserting that Charvin also discloses the same
`limitations of the challenged claims. See id. at 37, 39‒40, 42‒44, 47‒48,
`50‒52, 54‒55, 61. We do not understand, however, Petitioner to rely on
`Charvin as the primary reference, and Petitioner does not propose modifying
`Charvin with the teachings of Zimmerling.
`
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`For these two limitations, we review whether Petitioner relies on
`Charvin in substantially the same manner as the Examiner cited Zimmerling
`during prosecution such that Charvin discloses substantially the same
`information as Zimmerling in relevant part. As to the first limitation,
`Petitioner relies on Charvin for disclosure of “a planar disc shaped first
`attachment magnet within the coil housing,” arguing that Charvin discloses
`flat, circular magnets housed within separate casings. Pet. 44‒46 (citing
`Ex. 1004, 4:66–5:1, 6:34–39, 6:58–6:61, Figs. 4, 6, 9). During prosecution,
`the Examiner found that Zimmerling discloses this limitation. See Ex. 1007,
`84 (“Zimmerling discloses (Figures 8-9) . . . a planar disc shaped (col. 9,
`lines 34-47) first attachment magnet (805/901) within the plane of the coil
`housing”); see Prelim. Resp. 68–69. As such, both Charvin and Zimmerling
`disclose substantially the same magnet shape and configuration, thereby
`disclosing substantially the same information already considered by the
`Office. Thus, as to this first limitation, Charvin is substantially the same art
`as Zimmerling.
`As to the second limitation, Petitioner relies on Zimmerling for
`disclosure of “a freely turnable first attachment magnet” and relies on
`Charvin for disclosure of “a first attachment magnet oriented such that the
`magnetic dipole moment is substantially parallel to the outer surface of the
`coil housing and the skin when it is in transcutaneous