UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`BIOFRONTERA INCORPORATED, BIOFRONTERA BIOSCIENCE GMBH,
`BIOFRONTERA PHARMA GMBH, and BIOFRONTERA AG
`Petitioners
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`v.
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`DUSA PHARMACEUTICALS, INC.,
`Patent Owner
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`Case IPR2018-01585
`Patent 8,216,289
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`PATENT OWNER’S
`PRELIMINARY RESPONSE
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`Case IPR2018-01585
`Attorney Docket No: 46697-0001IP1
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`TABLE OF CONTENTS
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`B. 
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`C. 
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`D. 
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`INTRODUCTION ........................................................................................... 1 
`CLAIM CONSTRUCTION ............................................................................ 2 
`  THE PETITION SHOULD BE DENIED UNDER 35 USC § 325(d)
`BECAUSE IT PRESENTS THE SAME PRIOR ART AND ARGUMENTS AS
`PREVIOUSLY CONSIDERED BY THE OFFICE .................................................. 8 
`“the similarities and material differences between the asserted art and
`A. 
`the prior art evaluated during examination” .......................................... 9 
`“the cumulative nature of the asserted art and the prior art evaluated
`during examination” ............................................................................ 13 
`“the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for
`rejection” ............................................................................................. 13 
`“the extent of the overlap between the arguments made during
`examination and the manner in which Petitioner relies on the prior art
`or Patent Owner distinguishes the prior art” ....................................... 14 
`“whether Petitioner has pointed out sufficiently how the Examiner
`erred in its evaluation of the asserted prior art” .................................. 15 
`“the extent to which additional evidence and facts presented in the
`Petition warrant reconsideration of the prior art or arguments” ......... 15 
`The Board should exercise its discretion to deny institution of all
`grounds ................................................................................................ 15 
`  THE PETITION FAILS TO SHOW THAT THE CITED REFERENCES
`TEACH OR RENDER OBVIOUS “AN ILLUMINATOR WHOSE MEASURED
`OUTPUT OVER AN ACTIVE EMITTING AREA IS AT LEAST 60% OF THE
`MEASURED MAXIMUM OVER ALL OPERATION DISTANCES” ................ 17 
`A.  Ground 1: Claims 1, 2, 10, 12, and 16-19 Are Not Anticipated By
`Rowland ............................................................................................... 19 
`B.  Ground 2: Claims 1-2, and 4-19 Are Not Obvious Over Rowland In
`View Of The Knowledge Of A POSITA ............................................ 22 
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`E. 
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`F. 
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`G. 
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`F. 
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`C.  Ground 3: Claims 4-15 Are Not Obvious Over Rowland In View Of
`Lundahl, Further In View Of a POSITA ............................................. 24 
`D.  Ground 4: Claims 1-3, 12, and 16-19 Are Not Anticipated By Levin 24 
`Ground 5: Claims 1-19 Are Not Obvious Over Levin In View Of The
`E. 
`Knowledge Of A POSITA .................................................................. 26 
`Ground 6: Claims 4-15 Are Not Obvious Over Levin In View Of
`Lundahl, Further In View Of a POSITA ............................................. 27 
`G.  Ground 7: Claims 1-2 And 4-19 Are Not Obvious Over Bower In
`View Of The Knowledge Of a POSITA ............................................. 28 
`H.  Ground 8: Claims 4-15 Are Not Obvious Over Bower In View Of
`Lundahl, Further In View Of a POSITA ............................................. 30 
`CONCLUSION .............................................................................................. 30 
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`Case IPR2018-01585
`Attorney Docket No: 46697-0001IP1
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`LIST OF EXHIBITS
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`Exhibit No. Description
`DUSA-2001 File History for U.S. Patent No. 7,723,910
`DUSA-2002 File History for U.S. Patent No. 8,030,836
`DUSA-2003
`James C. Kennedy et al., “Photodynamic Therapy (PDT) and
`Photodiagnosis (PD) Using Endogenous Photosensitization Induced
`by 5-Aminolevulinic Acid (ALA): Mechanisms and Clinical
`Results”, Journal of Clinical Laser Medicine & Surgery, Volume
`14, Number 4, 1996 (“Kennedy”)
`DUSA-2004 Biofrontera’s Disclosure of Proposed Claim Constructions, Civil
`Action No. 1:18-cv-10568, (D. Mass.) Sept. 14, 2018
`DUSA-2005 U.S. Patent No. 6,709,446
`DUSA-2006 U.S. Patent No. 6,223,071
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`TABLE OF AUTHORITIES
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`CASES
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`Apotex Inc. v. Abraxis Bioscience, LLC, IPR2018-00151 ......................................... 3
`Ariosa Diagnostics, Inc. v. Verinata Health, Inc., Case IPR2013-00277 ................. 6
`Ball Aerosol v. Ltd. Brands, 555 F.3d 984 (Fed. Cir. 2009).............................. 23, 26
`Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586 ......... 3, 9, 12
`Bettcher Industries, 661 F.3d at 639-640 .......................................................... 21, 25
`Facebook, Inc. v. Sound View Innovations, LLC, PTAB, Case IPR2017-00985 .... 18
`Finnigan Corp. v. Int'l Trade Comm'n, 180 F.3d 1354, 1365
`(Fed. Cir. 1999) ............................................................................................ 21, 25
`In re Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004) ..................................................... 6
`In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ...................................................... 23
`In re Rijckaert, 9 F.3d 1531, 1533-1534 (Fed. Cir. 1993) ................................. 21, 25
`In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) ........................................ 20, 25
`Kamada, ITD. V. Grigols Therapeutics Inc., IPR2014-00899 ................................ 21
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ............................ 19, 22, 26
`Macauto USA, Inc. v. BOS GMBH & Co. KG, IPR2018-00480 ............................... 3
`Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369-71 (Fed. Cir. 2008) ..... 25
`Oatey Co. v. IPS Corp., 514 F.3d 1271, 1276 (Fed. Cir. 2008) ................................ 6
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) ........................................... 2
`SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018) ............................................ 16
`ScriptPro LLC v. Innovation Assocs., 833 F.3d 1336, 1341 (Fed. Cir. 2016) .......... 6
`Siemens Healthcare Diagnostics Inc. v. Radiometer Medical APS,
`Case IPR2018-00311 ......................................................................................... 17
`Tate & Lyle Americas LLC v. Cargill, Inc., IPR2014-00084 .................................. 21
`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) .......... 3
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`Attorney Docket No: 46697-0001IP1
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`STATUTES
`35 U.S.C. § 314 ........................................................................................................ 16
`35 U.S.C. § 325 .......................................................................................................... 8
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`OTHER AUTHORITIES
`37 C.F.R. § 42.100 ..................................................................................................... 2
`37 C.F.R. § 42.104 ..................................................................................................... 3
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`Case IPR2018-01585
`Attorney Docket No: 46697-0001IP1
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`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.107(a), Patent Owner DUSA Pharmaceuticals,
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`Inc. (“Patent Owner”) submits this Preliminary Response in response to the
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`Petition for Inter Partes Review (“IPR”) of U.S. Patent No. 8,216,289 (“the ’289
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`patent”) filed by Biofrontera Incorporated, Biofrontera Bioscience GmbH,
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`Biofrontera Pharma GmbH, and Biofrontera AG (hereinafter, collectively,
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`“Petitioner” or “Biofrontera”).
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`This Petition is merely an attempt to rehash references already presented to
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`the Board—references that all lack the same teaching of independent claim 1.
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`Accordingly, Petitioner has failed to meet its burden of showing a reasonable
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`likelihood that it would prevail. Institution should be denied for at least two
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`reasons.
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`First, Petitioner raises the same prior art already considered by the Office.
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`Two references (Bower and Levin) are the exact same references already
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`considered by the Examiner. A third reference (Lundahl) is just an earlier (shorter)
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`version of the same publication already considered by the Examiner. Five of the
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`eight grounds are based on nothing more than these three previously-considered
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`references. Petitioner adds a fourth reference (Rowland) for three of the grounds.
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`However, Rowland is not shown to disclose any more than the other references.
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`Even if it did, adding three grounds based on Rowland does not justify also
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`instituting five other grounds based entirely on references previously considered by
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`the Office.
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`Second, the primary references for all eight grounds all suffer from the same
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`critical flaw. Petitioner fails to show that any of Bower, Levin, or Rowland
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`disclose illuminating where the “measured output over an active emitting area is at
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`least 60% of the measured maximum over all operation distances.” Indeed,
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`Petitioner never even says what it contends constitutes “all operation distances” for
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`any of the references in effort to avoid contradicting its litigation position: that the
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`phrase “all operation distances” is purportedly indefinite and cannot be understood.
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`As a result, all eight grounds fail to address a limitation at the heart of independent
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`claim 1.
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`For at least these reasons, Patent Owner respectfully requests that the Board
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`deny institution of all grounds, and decline to institute inter partes review of the
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`’289 patent.
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` CLAIM CONSTRUCTION
`On September 19, 2018, the parties filed a Joint Motion requesting district
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`court type claim construction under 37 C.F.R. § 42.100(b). Accordingly, district
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`court type claim construction, as outlined in Phillips v. AWH Corp., 415 F.3d 1303
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`(Fed. Cir. 2005), is to be applied to the ’289 patent.
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` In determining whether to institute an IPR, the Board must “interpret the
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`claim language as it would be understood by one of ordinary skill in the art in light
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`of the specification.” Becton, Dickinson & Co. v. B. Braun Melsungen AG,
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`IPR2017-01586, slip op. at 6 (PTAB Dec. 15, 2017) (Paper 8). The Petition must
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`set forth how the challenged claims are to be construed. 37 C.F.R. § 42.104(b)(3).
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`Here, Petitioner proposed a single construction that is divorced from the ’289
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`specification and is clearly tailored as a narrow non-infringement position, having
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`nothing to do with this IPR proceeding. Petitioner’s litigation-focused construction
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`of the term “illuminator” should not be adopted for two reasons.
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`First, the Board should not adopt Petitioner’s proposed construction of
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`“illuminator” because construing the term is not necessary to resolve any disputes.
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`The law states that “claim terms need only be construed to the extent necessary to
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`resolve the controversy.” Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355,
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`1361 (Fed. Cir. 2011); see also Macauto USA, Inc. v. BOS GMBH & Co. KG,
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`IPR2018-00480, slip op. at 8-9 (PTAB Jun. 20, 2018) (Paper 9) (“We explicitly
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`construe only those claim limitations necessary to reach a decision on institution”);
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`Apotex Inc. v. Abraxis Bioscience, LLC, IPR2018-00151, slip op. at 8-9 (PTAB
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`May 8, 2018) (Paper 10). For purposes of deciding whether to institute IPR, there
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`is no controversy as to whether the references cited by Petitioner teach an
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`“illuminator.” Therefore, there is no need for the Board to construe “illuminator”
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`at all, let alone give it such a narrow construction.
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`Second, the Board should not adopt Petitioner’s proposed construction of
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`“illuminator” because it is wrong. If the Board concludes that the term
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`“illuminator” needs to be construed, the correct construction is “a light emitting
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`medical instrument.” This construction is consistent with the plain meaning of the
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`term as well as the claims and the specification. Ex. 1001, 1:21-23, 2:42-60, 16:6-
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`10.
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`Petitioner’s proposed construction of “illuminator” is not consistent with the
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`plain meaning of the term “illuminator.” Neither Petitioner nor its purported
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`expert argues that the ordinary meaning of “illuminator” to one of skill in the art is
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`“one or more light sources generally conforming to a contoured surface.” See
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`generally, Petition, 13-15; Ex. 1004, ¶¶ 60-61. Indeed, the ordinary meaning of
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`“illuminator” has nothing to do with conforming to a contoured surface.
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`Petitioner’s proposed construction of “illuminator” is also not consistent
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`with the claims. On the contrary, neither claim 1 nor any dependent claims
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`requires an illuminator to be “generally conforming to a contoured surface.” Ex.
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`1001, 16:6-59. Claim 1 simply says “an illuminator whose measured output over
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`an active emitting area is at least 60% of the measured maximum over all operation
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`distances.” Ex. 1001, 16:6-10.
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`Indeed, Petitioner points only to unclaimed details from a single
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`embodiment in the specification to justify its strained construction of “illuminator,”
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`yet the specification also undermines Petitioner’s position. Nothing in the intrinsic
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`record suggests that the inventions of the ’289 patent must be “conforming to a
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`contoured surface,” nor that “illuminator” has some special narrow meaning in
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`these claims. It is true that the ’289 patent discloses an embodiment of an
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`illuminator which “may comprise generally U-shaped fluorescent tubes.” See Ex.
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`1001, 6:16-17 (“[O]ne embodiment of the present invention utilizes a plurality of
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`U-shaped tubes.”) (emphasis added). But the specification also discloses a
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`different embodiment, namely an “infinite plane emitter” with light sources that
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`are “generally parallel to one another” but has no requirement that the light sources
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`themselves be of any particular shape:
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`“[T]here is also provided according to the present invention an
`illuminator for emulating an infinite plane emitter. The illuminator
`comprises an emitting area having a perimeter, and a plurality of light
`sources being generally parallel to one another, said plurality of light
`sources being adapted for irradiating substantially uniform intensity
`light from said emitting area. Lateral spacing between adjacent ones of
`said plurality of light sources varies with respect to said perimeter.”
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`See Ex. 1001, 3:36-44 (emphasis added).
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`Absent claim language carrying a clear narrow meaning or an express
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`disclaimer, the Board will not limit a claim based on the specification. See Ariosa
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`Diagnostics, Inc. v. Verinata Health, Inc., Case IPR2013-00277, slip op. at 6-7
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`(PTAB Oct. 25, 2013) (Paper 10), citing In re Bigio, 381 F.3d 1320, 1325 (Fed Cir.
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`2004). Indeed, Petitioner’s proposed construction is apparently crafted to narrowly
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`cover only one embodiment. As explained below, it fails even to accomplish that
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`goal because a set of U-shaped tubes will not necessarily “conform to a contoured
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`surface” in all circumstances. But the construction also explicitly excludes another
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`embodiment described in the ’289 patent specification—the “infinite plane
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`emitter”—and thus must be rejected. Oatey Co. v. IPS Corp., 514 F.3d 1271, 1276
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`(Fed. Cir. 2008) (“We normally do not interpret claim terms in a way that excludes
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`embodiments disclosed in the specification. . . . At leas[t] where claims can
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`reasonably [be] interpreted to include a specific embodiment, it is incorrect to
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`construe the claims to exclude that embodiment, absent probative evidence on the
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`contrary.”). “But a specification’s focus on one particular embodiment or purpose
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`cannot limit the described invention where that specification expressly
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`contemplates other embodiments or purposes.” ScriptPro LLC v. Innovation
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`Assocs., 833 F.3d 1336, 1341 (Fed. Cir. 2016).
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`When looking at the use of the term “illuminator” across the patent family, it
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`is also clear that Patent Owner has not acted as its own lexicographer to define the
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`term “illuminator” to have a specific narrow meaning. As one example, U.S.
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`Patent No. 6,709,446 claims an invention directed to an “illuminator” that
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`comprises “an arc-shaped portion” and that is “configured to conform to a portion
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`of a patient . . . .” Ex. DUSA-2005, claim 1. As another example, U.S. Patent No.
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`6,233,071 claims an “illuminator” that comprises “a plurality of light sources
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`generally conforming to the contoured surface and irradiating the contoured
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`surface . . . .” Ex. DUSA-2006, claim 1. In both of these examples, the Patent
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`Owner has identified further structural limitations of the illuminator to recite
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`“conforming” to a patient or a contoured surface, but has not redefined the term
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`“illuminator” itself to require a certain shape. In other words, when the Patent
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`Owner intended to require an illuminator to have a particular shape or structure, it
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`explicitly said so with additional claim limitations.
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`Petitioner is attempting to limit the invention to something that is not
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`actually required—“conforming to a contoured surface,” and doing so by relying
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`on the preferred U-shaped embodiment. But these concepts are not the same
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`because a “U-shaped” illuminator does not necessarily conform to a contoured
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`surface. For example, the surface of a patient’s skin has many curved and flat
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`surfaces. The specification explicitly contemplates that the invention could be
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`used for “arms, legs, etc.” Ex. 1001, 1:26-29. Yet no one illuminator could be
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`contoured to match all of them. The fact that the illuminator shown in Figure 1 of
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`the ’289 patent uses a U-shaped emitting surface does not mean that all
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`illuminators contemplated by the invention necessarily conform to any or all
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`contoured surfaces.
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`Accordingly, not even the specification supports Petitioner’s strained
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`construction of “illuminator.” Thus, Petitioner’s proposed construction of
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`“illuminator” is wrong and should not be adopted.
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` THE PETITION SHOULD BE DENIED UNDER 35 USC § 325(d)
`BECAUSE IT PRESENTS THE SAME PRIOR ART AND ARGUMENTS
`AS PREVIOUSLY CONSIDERED BY THE OFFICE
`Institution of Grounds 1-8 should be denied because the art and issues raised
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`have already been addressed by the USPTO during original prosecution. 35 USC §
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`325(d). The Petition’s eight grounds constitute various permutations of four
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`references. These references are: Rowland, Bower, Levin, and Lundahl. Of these
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`references, Bower and Levin were already cited during prosecution. Petitioner
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`relies on Lundahl only to address specific treatments and other limitations in
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`dependent claims 4-15. Accordingly, Rowland is the only reference that Petitioner
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`applies to independent claim 1 that even purports to be new.
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`However, Petitioner does not identify any teaching in Rowland that is
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`different than what was already before the Examiner. Petitioner presents Rowland
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`as teaching an illuminator that provides substantially uniform illumination of a
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`treatment area, but that is the same thing that Petitioner alleges is also taught in
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`Bower and Levin. Petitioner does not identify anything in Rowland that
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`supposedly meets claim limitations any better than Bower and Levin. The
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`references are cumulative. Accordingly, Petitioner is essentially asking the Board
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`to revisit the same art and issues that were already before the Office without
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`identifying any specific error committed by the Examiner.
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`Section 325(d) states that “[i]n determining whether to institute . . . the
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`Director may take into account whether . . . the same or substantially the same
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`prior art or arguments previously were presented to the Office.” 35 USC § 325(d).
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`The Board considers a set of non-exclusive factors to determine whether it should
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`exercise its discretion to deny institution. Becton, Dickinson & Co. v. B. Braun
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`Melsungen AG, Case IPR2017-01586, slip op. at 17-18 (PTAB Dec. 15, 2017)
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`(Paper 8) (Designated Informative Mar. 21, 2018).
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`These factors are considered in order.
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`A.
`“the similarities and material differences between the asserted art
`and the prior art evaluated during examination”
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`Of the four references cited by Petitioner, two are the exact same references
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`evaluated during examination and the other two are cumulative of references
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`already evaluated during examination. Specifically, Bower and Levin are the very
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`same references evaluated during examination of the application that issued as the
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`’289 patent. Bower and Levin were listed on an IDS filed by the applicant on
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`10/16/2010, which was signed as considered by the Examiner 4/22/2012. See Ex.
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`1002, 16-17, 150-153.
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`Lundahl (which is cited in the Petition only for dependent claims) was not
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`specifically cited during prosecution but is not materially different than another
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`reference that was cited during prosecution. Lundahl is a publication titled
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`“Photodynamic Therapy (PDT) and Photodiagnosis (PD) Using Endogenous
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`Photosensitization Induced by 5-Aminolevulinic Acid (ALA): Current Clinical and
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`Development Status” from a 1996 issue of the Journal of Clinical Laser Medicine
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`& Surgery. See Ex. 1010, 1. The Lundahl publication is substantially similar to
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`“Photodynamic Therapy (PDT) and Photodiagnosis (PD) Using Endogenous
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`Photosensitization Induced by 5-Aminolevulinic Acid (ALA): Mechanisms and
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`Clinical Results” by Kennedy et al. (“Kennedy”). See Ex. DUSA-2003, 1.
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`Applicant cited Kennedy on 10/16/2010, which was considered by the Examiner
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`4/22/2012. See Ex. 1002, 16-17, 150-153. The title of Kennedy is nearly identical
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`to that of Lundahl. Compare Ex. 1010, 1 with Ex. DUSA-2003, 1. While
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`Petitioner refers to Exhibit 1010 as “Lundahl,” the first named author of that
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`publication is actually Stuart L. Marcus, M.D., Ph.D. See Ex. 1010, 1. Dr. Marcus
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`is also the second author named in the Kennedy publication. See Ex. DUSA-2003,
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`1. Both Lundahl and Kennedy were published in the same Journal of Clinical
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`Laser Medicine & Surgery in the same year. See Ex. 1010, 1; Ex. DUSA-2003, 1.
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`Most importantly, the Kennedy publication is about twice as long as the
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`Lundahl publication and includes most of the same material disclosed in the
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`Lundahl publication with additional material added. Compare Ex. 1010 with Ex.
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`DUSA-2003. For example, one can see that all four Tables in Lundahl were
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`reproduced with only minor formatting changes in Kennedy and that most of the
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`text in Lundahl (after Lundahl’s introduction) is reproduced word-for-word in
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`Kennedy. Compare Ex. 1010, 2-7 with Ex. DUSA-2003, 7-13. Kennedy is a more
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`detailed follow-up paper to Lundahl. Compare Ex. 1010 with Ex. DUSA-2003.
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`There are no differences between Lundahl and Kennedy that are material with
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`respect to this proceeding. Compare Ex. 1010 with Ex. DUSA-2003.
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`Accordingly, Petitioner’s assertion that the Lundahl was not considered by the
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`Examiner (see Petition, 15) ignores the fact that the Examiner considered the same
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`subject matter in Kennedy.
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`Rowland was not cited during prosecution of the ’289 patent. However,
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`Petitioner has not identified (and there does not appear to be) any material
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`differences between Rowland and the references that were evaluated during
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`examination. See Petition, 15-67. For example, in comparing Rowland, Levin,
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`and Bower to claim 1, Petitioner treats all three references as essentially the same.
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`See Petition, 22-24, 38-41, 54-57. Petitioner does not identify any material
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`differences between the three primary references. See id. For example, Petitioner
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`relies on each of Rowland, Levin, and Bower as teaching curved illuminators with
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`one or more light sources that are believed to provide substantially uniform
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`illumination at one or more distances. See Petition, 22-24, 38-41, 54-57.
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`Petitioner mentions that Rowland uses a single laser light source transmitted
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`by one or more optical fibers, as opposed to florescent lamps as disclosed in Levin
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`and LEDs as disclosed in Bower (see Petition, 15-20), but Petitioner does not state
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`why these or any other differences between the references are material differences.
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`Additionally, all three references suffer the same flaw for failing to address the
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`claim limitation regarding “the measured maximum over all operation distances.”
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`See, infra, Section IV. Because Petitioner does not identify any way in which
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`Rowland is materially different than Levin and Bower, the fact that Rowland is
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`technically a different reference matters little. See Becton, Dickinson & Co. v. B.
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`Braun Melsungen AG, Case IPR2017-01586, slip op. at 21 (“We cannot reasonably
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`consider such differences ‘material’ because… Petitioner has not relied on, or
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`substantively addressed, any particular differences between Rogers and
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`Tauschinski valve structure as a basis for unpatentability in the Petition”) (PTAB
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`Dec. 15, 2017) (Paper 8) (Designated Informative Mar. 21, 2018).
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`Accordingly, all four references cited by Petitioner were either directly
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`before the Examiner (Levin and Bower) or were not materially different (Rowland
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`and Lundahl/Kennedy). Accordingly, this factor favors denial of institution.
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`B.
`“the cumulative nature of the asserted art and the prior art
`evaluated during examination”
`As explained above in Section III.A, there is no material difference between
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`Lundahl and the references that were evaluated during examination (e.g. Kennedy).
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`Also, Petitioner has identified no material difference between Rowland and the
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`references that were evaluated during examination (e.g. Levin and Bower).
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`Lundahl and Rowland are merely cumulative of those references already
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`considered. Accordingly, this factor also favors denial of institution.
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`C.
`“the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for
`rejection”
`The references were evaluated several times by the same Examiner over the
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`course of prosecution of the ’289 patent and previous family members.
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`For example, Bower, Levin, and Kennedy (which is the more detailed
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`version of Lundahl) were listed on an IDS filed by the applicant on 10/16/2010 and
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`were signed as considered by Examiner Joseph Williams on 4/22/2012. See Ex.
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`1002, 16-17, 150-153. This was not the first time that the same Examiner had seen
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`these references. The same Examiner also considered Bower, Levin, and Kennedy
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`(the more detailed version of Lundahl) on 1/6/2011 during prosecution of the
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`parent to the ’289 patent. Ex. DUSA-2002, 137-139. The same Examiner also
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`considered Bower, Levin, and Kennedy (the more detailed version of Lundahl) on
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`6/3/2009 during prosecution of the grandparent to the ’289 patent. Ex. DUSA-
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`2001, 61-63. For example, in one office action in the grandparent to the ’289, the
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`same Examiner rejected claims “as being unpatentable over Kennedy et al. (US
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`5,079,262) in view of Bower et al. (WO 93/21842), both of record by Applicant.
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`Ex. DUSA-2001, 56-57 (emphasis added). Therefore, the same Examiner
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`considered all three references at least three different times.
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`Accordingly, there is substantial evidence to show that the same Examiner
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`actually evaluated Bower, Levin, and Kennedy (the more detailed version of
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`Lundahl) both during prosecution of the ’289 patent and in previous family
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`members. While Rowland was not specifically evaluated during examination,
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`Petitioner has shown no material difference between the teachings of Rowland and
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`the teachings of Bower and Levin (as explained above in Sections III.A-III.B).
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`Therefore, this factor also favors denial of institution.
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`D.
`“the extent of the overlap between the arguments made during
`examination and the manner in which Petitioner relies on the prior art
`or Patent Owner distinguishes the prior art”
`This factor is neutral because there were no substantive rejections in the
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`prosecution of the ’289 patent.
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`E.
`“whether Petitioner has pointed out sufficiently how the
`Examiner erred in its evaluation of the asserted prior art”
`Petitioner has pointed out no error made by the Examiner in evaluating
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`Bower, Levin, and Kennedy (the more detailed version of Lundahl). Therefore,
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`this factor also favors denial of institution.
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`F.
`“the extent to which additional evidence and facts presented in the
`Petition warrant reconsideration of the prior art or arguments”
`Petitioner has presented no additional evidence suggesting reconsideration
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`of Bower, Levin, and Kennedy (the more detailed version of Lundahl). While
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`Petitioner has cited a fourth reference (Rowland) that was not before the Examiner,
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`Petitioner has identified no material difference between Rowland and Bower or
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`Levin. Moreover, Petitioner has identified no facts presented in Rowland that
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`suggest that Bower, Levin, and Lundahl/Kennedy should be reconsidered.
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`Therefore, this factor also favors denial of institution.
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`G. The Board should exercise its discretion to deny institution of all
`grounds
`The Board should deny institution of the Petition in its entirety because
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`Petitioner seeks reconsideration of references that were previously presented to the
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`Office. The Petition presents eight grounds, the last five of which are based only
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`on references that were previously considered by the Examiner during prosecution
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`(Bower, Levin, and Lundahl which was presented as Kennedy). See Ex. 1002, 16-
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`17, 150-153.
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`Prior to the US Supreme Court’s decision in SAS Institute, the Board could
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`and likely would have denied institution of at least Grounds 4-8 under § 325(d) for
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`presenting the same references that were previously presented to the Office. Here,
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`Petitioner appears to be trying to take advantage of the post-SAS rules by adding a
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`single new reference (Rowland) in hopes of forcing the Board to also consider five
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`other grounds with no new references. This strategy should be denied for multiple
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`reasons.
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`First, even if, for sake of argument, Rowland were a truly new and
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`materially different reference—which it is not—the Board still can and should
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`deny institution of the entire Petition to discourage parties of this kind of
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`gamesmanship. Parties should not be able to force the Board to consider eight
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`grounds of mostly old references simply by adding a single new reference. The
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`decision in SAS Institute may have eliminated the Board’s ability to perform partial
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`institutions, but it confirms that the Board has broad discretion whether to institute
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`review. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018) (“while § 314(a)
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`invests the Director with discretion on the question whether to institute review, it
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`doesn’t follow that the statute affords him discretion regarding what claims that
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`review will encompass”) (emphasis in original).
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`Second, Rowland is not really new in a material way, because Petitioner has
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`identified nothing in Rowland that is materially different than either Bower or
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`Levin. See, supra, Sections III.A-III.B.
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`Finally, Petitioner fails to address how Rowland satisfies the