UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`BIOFRONTERA INCORPORATED, BIOFRONTERA BIOSCIENCE GMBH,
`BIOFRONTERA PHARMA GMBH, and BIOFRONTERA AG
`Petitioners
`
`v.
`
`DUSA PHARMACEUTICALS, INC.
`Patent Owner
`
`
`Inter Partes Review Case No. 2018-______
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,216,289
`UNDER 35 U.S.C. §§ 311–319 AND 37 C.F.R. § 42.100 et seq.
`
`
`

`

`
`
`
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`TABLE OF CONTENTS
`
`
`
`I. 
`
`II. 
`
`MANDATORY NOTICES ............................................................................ 1 
`A. 
`Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ................................... 1 
`B. 
`Related Matters (37 C.F.R. § 42.8(b)(2)) ............................................. 2 
`C. 
`Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) ............................ 2 
`D. 
`Service Information (37 C.F.R. § 42.8(b)(4)) ...................................... 3 
`E. 
`Payment of Fees (37 C.F.R. §§ 42.15(a) and 42.103(a)) ..................... 3 
`F. 
`Grounds for Standing (37 C.F.R. § 42.104(a)) .................................... 3 
`OVERVIEW OF CHALLENGE AND RELIEF REQUESTED ................... 3 
`A. 
`Publications Relied Upon ..................................................................... 4 
`B. 
`Grounds For Challenge (37 C.F.R. §§42.104(b)(1) & (b)(2)) ............. 4 
`III.  THE CONTESTED PATENT ........................................................................ 5 
`A. 
`Effective Filing Date of the ’289 Patent .............................................. 5 
`B. 
`Overview of the ’289 Patent ................................................................. 6 
`C. 
`Prosecution History .............................................................................. 9 
`D. 
`Claim Construction ............................................................................ 11 
`1. 
`Level of Ordinary Skill in the Art ............................................ 11 
`2. 
`Petitioners’ Proposed Constructions ........................................ 11 
`3. 
`Claims 1–6 and 16–19: Illuminator ........................................ 13 
`IV.  SUMMARY OF PRIOR ART AND REFERENCES RELIED ON ............ 15 
`A. 
`Brief Summary of Rowland (Ex. 1009) ............................................. 15 
`B. 
`Brief Summary of Lundahl (Ex. 1010) .............................................. 17 
`C. 
`Brief Summary of Levin (Ex. 1011) .................................................. 18 
`D. 
`Brief Summary of Bower (Ex. 1012) ................................................. 20 
`V.  A REASONABLE LIKELIHOOD EXISTS THAT THE
`CHALLENGED CLAIMS ARE UNPATENTABLE ................................. 22 
`A.  Ground 1: Claims 1, 2, 10, 12, and 16–19 of the ’289 Patent are
`anticipated by Rowland. ..................................................................... 22 
`Ground 2: Claims 1-2 and 4–19 of the ’289 Patent are obvious
`over Rowland in view of the knowledge of a POSITA. .................... 27 
`
`B. 
`
`105780611.2
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`TABLE OF AUTHORITIES
`(continued)
`
`
`
`C. 
`
`Ground 3: Claims 4–15 of the ’289 Patent are obvious over
`Rowland in view of Lundahl, further in view of the knowledge
`of a POSITA. ...................................................................................... 32 
`D.  Ground 4: Claims 1-3, 12, and 16–19 of the ’289 Patent are
`anticipated by Levin. .......................................................................... 38 
`Ground 5: Claims 1–19 of the ’289 Patent are obvious over Levin
`in view of the knowledge of a POSITA. ............................................ 44 
`Ground 6: Claims 4–15 of the ’289 Patent are obvious over Levin
`in view of Lundahl, further in view of the knowledge of a
`POSITA. ............................................................................................. 49 
`G.  Ground 7: Claims 1-2 and 4-19 of the ’289 Patent are obvious
`over Bower in view of the knowledge of a POSITA ......................... 54 
`H.  Ground 8: Claims 4–15 of the ’289 Patent are obvious over
`Bower in view of Lundahl, further in view of the knowledge of
`a POSITA ........................................................................................... 61 
`VI.  CONCLUSION ............................................................................................. 67 
`
`
`
`E. 
`
`F. 
`
`
`
`
`
`-ii-
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`TABLE OF AUTHORITIES
`
`
`CASES
`Chicago Bd. Options Exch., Inc. v. Int’l Sec. Exch., LLC, 677 F.3d
`1361 (Fed. Cir. 2012) .................................................................................... 12, 14
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005
`(Fed. Cir. 2006) ................................................................................................... 12
`Digital Check Corp. v. E-Imagedata Corp., IPR2017-00178, Paper 6
`(PTAB April 25, 2017) ....................................................................................... 10
`Dusa Pharmaceuticals, Inc. v. Biofrontera Inc. et al (Civil Action No.
`1:18-cv-10568) ...................................................................................................... 2
`First Quality Baby Products, LLC v. Kimberly-Clark Worldwide, Inc.,
`IPR2014-01021, Final Written Decision (PTAB December 10,
`2015) ................................................................................................................... 28
`Fox Factory, Inc. v. SRAM, LLC, IPR2017-00427, Paper 10 (PTAB
`April 21, 2017) .................................................................................................... 10
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) .........................................passim
`Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509 (Fed. Cir. 2015) .................... 12, 15
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) ......................... 12
`In re Rambus, Inc., 694 F.3d 42 (Fed. Cir. 2012) .................................................... 11
`Unified Patents, Inc. v. Berman, IPR2016-01571, Paper 10 (Dec. 14,
`2016) ................................................................................................................... 11
`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355 (Fed. Cir. 2011) .................. 13
`STATUTES
`35 U.S.C. § 102 ...................................................................................................... 4, 5
`35 U.S.C. § 102(b) ............................................................................................... 4, 15
`35 U.S.C. § 103 ...................................................................................................... 4, 5
`35 U.S.C. § 112 .................................................................................................... 6, 13
`35 U.S.C. §§ 311-319 .......................................................................................... 1, 67
`35 U.S.C. § 315 .......................................................................................................... 1
`35 U.S.C. § 325(d) ................................................................................................... 10
`
`105780611.2
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`iii
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`TABLE OF AUTHORITIES
`(continued)
`
`
`REGULATIONS
`37 C.F.R. § 42.8 ................................................................................................passim
`37 C.F.R. § 42.15 ....................................................................................................... 3
`37 C.F.R. § 42.100 ..................................................................................................... 1
`37 C.F.R. § 42.103 ..................................................................................................... 3
`37 C.F.R. § 42.104 ..................................................................................................... 3
`37 C.F.R. § 42.104(b) ................................................................................................ 3
`37 C.F.R. §§42.104(b)(1) & (b)(2) ............................................................................ 4
`MPEP § 2143 ....................................................................................................passim
`
`
`
`
`
`-iv-
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`PETITIONERS’ EXHIBITS
`
`
`
`
`
`1001
`1002
`1003
`
`1004
`1005
`1006
`1007
`1008
`1009
`
`1010
`
`Exhibit No. Description
`U.S. Patent No. 8,216,289 by Scott Lundahl et al. entitled
`“Illuminator for Photodynamic Therapy” (“the ’289 Patent”)
`File History for U.S. Patent No. 8,216,289
`Dusa Pharmaceuticals, Inc. v. Biofrontera Inc., Civil Action No.
`1:18-cv-10568, (D. Mass.) filed March 23, 2018
`Declaration of Irving J. Bigio, Ph.D.
`Declaration of Sylvia Hall-Ellis, Ph.D.
`File History for U.S. Patent No. 7,190,109
`File History for U.S. Patent No. 6,223,071
`File History for U.S. Patent No. 6,709,446
`International Publication WO 90/00420 to Adrian Rowland et al.,
`entitled “Light Delivery System” (“Rowland”)
`(PDT) and
`Scott Lundahl et al., Photodynamic Therapy
`Photodiagnosis (PD) Using Endogenous Photosensitization Induced
`by 5-Aminolevulinic Acid
`(ALA): Current Clinical and
`Development Status, Journal of Clinical Laser Medicine & Surgery
`Volume 14, Number 2, 1996 (“Lundahl”)
`U.S. Patent No. 4103175 to Robert Levin, entitled “Phototherapy
`Irradiation Chamber” (“Levin”)
`
`International Publication WO 93/21842 to Robert Bower et al.,
`entitled, “High-Power Light Emitting Diodes for Photodynamic
`Therapy” (“Bower”)
`Vincent Allen, et al., A simple projector for superficial laser
`photodynamic therapy, Phys. Med. Biol., 1989, Vol. 34, No 7, 927-
`930 (“Allen”)
`G.I. Lozovaya, et al., Protoporphyrin IX as a Possible Ancient
`Photosensitizer: Spectral and Photochemical Studies, Origins of Life
`and Evolution of the Biosphere, vol. 20, issue 3-4 (May 1990): 321-
`330 (“Lozovaya”)
`Steven S. Zumdahl, Chemical Principles. 2nd ed., 1995 (“Zumdahl”)
`International Publication WO 93/18715 to Anderson, entitled “Laser
`Illuminator” (1993)
`Wilson, et al., Instrumentation and light dosimetry for intra-operative
`photodynamic therapy (PDT) of malignant brain tumours, Phys.
`Med. Biol., 1986, Vol 31, No. 2, 125-133 (1986)
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`1016
`
`1017
`
`105780611.2
`
`v
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Warloe, et al., Localization of porphyrins in human basal cell
`carcinoma and normal skin tissue induced by topical application of
`5-aminolevulinic acid in PHOTODYNAMIC THERAPY AND
`BIOMEDICAL LASERS, (P. Spinelli, M. Dal Fante and R.
`Marchesini, eds. 1992)
`Smetana et al., Treatment of Viral Infections with 5-Aminolevulinic
`Acid and Light, Lasers in Surgery and Medicine 21:351–358 (1997)
`
`1018
`
`1019
`
`-vi-
`
`
`
`
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Pursuant to 35 U.S.C. §§ 311-319, Biofrontera Incorporated, Biofrontera
`
`Bioscience GmbH, Biofrontera Pharma GmbH, and Biofrontera AG (collectively,
`
`“Petitioners”) hereby respectfully request inter partes review of claims 1–19
`
`(“Challenged Claims”) of U.S. Patent No. 8,216,289 (“the ’289 Patent”). There
`
`exists a reasonable likelihood that Petitioners will prevail with respect to at least one
`
`of the Challenged Claims, which are unpatentable over the prior art identified herein.
`
`I. MANDATORY NOTICES
`Pursuant to 37 C.F.R. § 42.8, Petitioners provides the following disclosures:
`
`A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`The real parties-in-interest for Petitioners are Biofrontera Incorporated,
`
`Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, and Biofrontera AG.
`
`Additionally, Petitioners further identify Biofrontera Neuroscience GmbH and
`
`Biofrontera Development GmbH as real parties-in-interest for the IPR requested by
`
`this Petition, solely to the extent that Patent Owner contends that these separate legal
`
`entities should be named real parties-in-interest in the requested IPR, and Petitioner
`
`does so to avoid the potential expenditure of resources to resolve such a challenge.
`
`No unnamed entity is funding, controlling, or otherwise has an opportunity to control
`
`or direct this Petition or Petitioners’ participation in any resulting IPR. Also,
`
`Petitioners note that Biofrontera Inc. has several commonly owned entities, and each
`
`of these entities agrees to be estopped under the provisions of 35 U.S.C. § 315 as a
`
`105780611.2
`
`1
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`result of any final written decision in the requested IPR to the same extent that
`
`Petitioners are estopped.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`The ’289 Patent is currently the subject of litigation against Petitioners in the
`
`District of Massachusetts, originally captioned Dusa Pharmaceuticals, Inc. v.
`
`Biofrontera Inc. et al (Civil Action No. 1:18-cv-10568) filed March 23, 2018. A
`
`copy of the Complaint from the District Court Litigation is attached as Ex. 1003.
`
`Petitioners are also concurrently filing a petition for inter partes review of
`
`U.S. Patent No. 9,723,991 (“the ’991 Patent”). The ’289 Patent claims priority to
`
`the same original parent application as the ’991 Patent, and shares the same
`
`disclosure.
`
`C. Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3))
`
`Lead Counsel:
`Rachelle H. Thompson (Reg. No. 50,860)
`
`Email:
`BIOFRONTERA@mcguirewoods.com
`
`Postal/Hand Delivery Address:
`MCGUIREWOODS LLP
`434 Fayetteville St., Suite 1400
`Raleigh, NC 27601
`
`Tel.: (919) 755-6600
`Fax.: (919) 755-6699
`
`
`
`
`Backup Counsel:
`George B. Davis (Reg. No. 68,205)
`
`Email:
`BIOFRONTERA@mcguirewoods.com
`
`Postal/Hand Delivery Address:
`MCGUIREWOODS LLP
`Gateway Plaza
`800 East Canal Street
`Richmond, VA 23219
`
`Tel.: (804) 775-1000
`Fax.: (804) 775-2016
`
`
`
`-2-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`
`D.
`Service on Petitioners may be made by email, mail, or hand delivery at the
`
`addresses shown above. A power of attorney is submitted with this Petition.
`
`Payment of Fees (37 C.F.R. §§ 42.15(a) and 42.103(a))
`
`E.
`The Office is authorized to charge the fees specified by 37 C.F.R. §§ 42.103(a)
`
`and 42.15(a) to Deposit Account No. 23-1951 as well as any additional fees that
`
`might be due in connection with this Petition.
`
`F. Grounds for Standing (37 C.F.R. § 42.104(a))
`Petitioners certify that the ’289 Patent is eligible for inter partes review and
`
`that Petitioners are not barred or estopped from requesting the inter partes review
`
`sought herein.
`
`II. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED
`Pursuant to 37 C.F.R. § 42.104(b), Petitioners request inter partes review of
`
`the Challenged Claims on the grounds set forth below and request that the
`
`Challenged Claims be cancelled based on the grounds of unpatentability set forth in
`
`Section II.B below. Additional support for each ground is set forth in the Declaration
`
`of Irving J. Bigio, Ph.D., Ex. 1004.
`
`
`
`-3-
`
`

`

`A.
`
`Publications Relied Upon
`
`Exhibit
`
`Reference
`
`1009
`
`1010
`
`1011
`
`1012
`
`
`
`International Publication WO
`90/00420 (“Rowland”)
`Photodynamic Therapy
`(PDT) and Photodiagnosis
`(PD) Using Endogenous
`Photosensitization Induced by
`5-Aminolevulinic Acid
`(ALA): Current Clinical and
`Development Status, Journal
`of Clinical Laser Medicine &
`Surgery Volume 14, Number
`2, 1996 (“Lundahl”)
`U.S. Patent No. 4,103,175
`(“Levin”)
`International Publication
`WO 93/21842 (“Bower”)
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Publication Date Availability
`as Prior Art1
`§ 102(b)
`
`January 25, 1990
`
`No later than
`September 5,
`19962
`
`§ 102(b)
`
`July 25, 1978
`
`§ 102(b)
`
`November 11,
`1993
`
`§ 102(b)
`
`B. Grounds For Challenge (37 C.F.R. §§42.104(b)(1) & (b)(2))
`Petitioners request cancellation of claims 1–19 on the grounds below.
`
`Ground Claims
`
`Basis
`
`I
`
`II
`
`1-2, 10, 12, 16–
`19
`1-2, 4–19
`
`Under 35 U.S.C. § 102 as anticipated by Rowland
`
`Under 35 U.S.C. § 103 as obvious over Rowland
`in view of the knowledge of a person of ordinary
`skill in the art (“POSITA”)
`
`
`1 All references to §§ 102 and 103 of the Patent Statute refer to the pre-AIA versions
`
`of those statutory provisions.
`
`2 Ex. 1005 at ¶¶ 39-46.
`
`
`
`-4-
`
`

`

`4–15
`
`1–3, 12, 16–19
`1–19
`
`4–15
`
`1-2, 4–19
`
`4–15
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Under 35 U.S.C. § 103 as obvious over Rowland
`in view of Lundahl, further in view of the
`knowledge of a POSITA
`Under 35 U.S.C. § 102 as anticipated by Levin
`Under 35 U.S.C. § 103 as obvious over Levin in
`view of the knowledge of a POSITA
`Under 35 U.S.C. § 103 as obvious over Levin in
`view of Lundahl, further in view of the knowledge
`of a POSITA
`Under 35 U.S.C. § 103 as obvious over Bower in
`view of the knowledge of a POSITA
`Under 35 U.S.C. § 103 as obvious over Bower in
`view of Lundahl, further in view of the knowledge
`of a POSITA
`
`III
`
`IV
`V
`
`VI
`
`VII
`
`VIII
`
`
`
`III. THE CONTESTED PATENT
`A. Effective Filing Date of the ’289 Patent
`The ’289 Patent, filed on December 16, 2010, purports to be a continuation of
`
`Application No. 12/621,845, filed on November 19, 2009 (now U.S. Patent No.
`
`8,030,836), which is a continuation of Application No. 11/716,014, filed on March
`
`9, 2007 (now U.S. Patent No. 7,723,910), which is a continuation of Application No.
`
`10/755,318, filed on January 13, 2004 (now Pat. No. 7,190,109), which is a
`
`divisional of Application No. 09/774,084, filed on January 31, 2001 (now Pat. No.
`
`6,709,446), which is a divisional of Application No. 09/070,772, filed on May 1,
`
`1998 (now Pat. No. 6,223,071). All of the prior art references precede the earliest
`
`
`
`-5-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`possible priority date—May 1, 1998—by more than a year.3 Thus, the “time of the
`
`invention” for claims 1–19 of the ’289 Patent is May 1, 1998.4
`
`B. Overview of the ’289 Patent
`Independent claim 1 and dependent claims 2–19 of the ’289 Patent are drawn
`
`to methods of photodynamically diagnosing or treating patients by illuminating them
`
`with light from an illuminator. Ex. 1001 at Abstract, 2:40–48; Figure 1. The
`
`specification defines the term “light” as “radiant energy including the ultraviolet
`
`(UV), infrared (IR) and visible ranges of the electromagnetic radiation spectrum.”
`
`Id. at 1:32–34. In photodynamic therapy (“PDT”) or photodynamic diagnosis
`
`(“PD”), a patient is administered a photoactivatable drug or precursor of a
`
`photoactivatable drug. Id. at 1:37–50. The photoactivatable drug accumulates in
`
`the target area to be treated or diagnosed. Id. The patient is exposed to light that
`
`overlaps with the optical activation spectrum of the photoactivatable drug. Id. at
`
`2:24–36.
`
` The light causes a chemical and/or biological change in the
`
`
`3 Petitioners do not concede that any of the Challenged Claims are entitled to a
`
`priority date of May 1, 1998.
`
`4 Any reference to the “time of the invention” of the Challenged Claims of the ’289
`
`Patent is not an admission that the Challenged Claims of the ’289 Patent satisfy the
`
`requirements of 35 U.S.C. § 112.
`
`
`
`-6-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`photoactivatable drug, which in turn results in the destruction or alteration of the
`
`target area. Id. at 1:37–50. That destruction or alteration is used to treat or diagnose
`
`ailments such as skin cancer, precancerous lesions, acne, photo damaged skin, warts,
`
`psoriasis, or hair removal. Id. at 15:12–16, 38–46. The non-target areas incur only
`
`mild or reversible damage. Id. at 1:37–50.
`
`The illuminator disclosed in the ’289 Patent is a contoured, non-planar device
`
`as shown in Figure 1 below. Id. at 4:66–67, Fig. 1 (disclosing a partial cross section,
`
`front elevation view of an illuminator comprising a plurality of U-shaped fluorescent
`
`tubes).
`
`
`
`-7-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`
`
`In the disclosed embodiment, the illuminator produces visible light of
`
`consistent uniformity over a contoured surface—defined in the specification as a
`
`non-planar surface. Id. at 2:44–48. The illuminator also includes a microcontroller
`
`that supports maintenance of output irradiance. Id. at 8:31–39. The ’289 Patent does
`
`not purport to have invented PDT, PD, illuminators, and the use of the same to treat
`
`
`
`-8-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`or diagnose various ailments. That technology was admittedly known in the art. Id.
`
`at 8:31–39; Ex. 1004 at ¶ 33-35. Rather, the specification discloses a purported
`
`improved illuminator for PDT and PD. Id. at 2:42–43. As explained in detail below,
`
`numerous prior art references disclose or teach the claimed illuminator with uniform
`
`output of light.
`
`Prosecution History
`
`C.
`The ’289 Patent was filed on December 16, 2010, as application number
`
`12/969,999. Petitioner summarizes here the actions most relevant to the grounds of
`
`unpatentability set forth in the present Petition. The Examiner allowed the claims in
`
`his first office action of April 26, 2012. Ex. 1002, pp. 12. The reason for allowance
`
`indicates that the prior art of record “neither shows nor suggest a method of
`
`photodynamically diagnosing or treating a patient, comprising: illuminating the
`
`patient with an illuminator whose measured output over an active emitting area is at
`
`least 60% of the measured maximum over all operation distances.” Id.
`
`Although cited on the face of an IDS during prosecution, Bower and Levin,
`
`upon closer inspection and with calculation of the values disclosed therein,
`
`demonstrate the unpatentability of claim 1 and claims dependent thereon. For
`
`example, the contoured illuminator in Levin has a plurality of fluorescent lamps
`
`spaced so that it provides substantial uniformity of irradiance throughout the whole
`
`irradiation chamber for treatment of skin conditions. Ex. 1011 at Abstract, 1:17–57.
`
`
`
`-9-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Levin further discloses that “the irradiance at substantially all points within the
`
`irradiation space is within about plus or minus 25% of the average irradiance value
`
`within said space.” Id. at Claim 3.5 Thus, the substantial uniformity in Levin occurs
`
`at all points, including at distances of 2” and 4”. See Ex. 1004 at ¶ 329-338.
`
`Similarly, Bower discloses a contoured illuminator with uniform output of
`
`light for skin tissue. Ex. 1012 at 10:7–24, 13:34–35; see id. at claim 9 (claiming a
`
`light system that permits a “uniform light dose to be delivered to non-flat
`
`surfaces”). The illuminator in Bower includes an array of light emitting diodes
`
`(“LEDs”) in a spaced relationship and a controller connect to the LED array. Id. at
`
`19:33–20:17, claim 3. Bower discloses “uniformity of light intensity” at 5 cm (i.e.,
`
`2 inches) and 10 cm (i.e., 2 inches). Id. at 13:34–35, Fig. 12.
`
`Accordingly, the Board should not exercise its discretion under 35 U.S.C. §
`
`325(d) and deny the petition solely on the basis that Levin and Bower were listed in
`
`an IDS. See, e.g., Fox Factory, Inc. v. SRAM, LLC, IPR2017-00427, Paper 10 at 7
`
`(PTAB April 21, 2017); Digital Check Corp. v. E-Imagedata Corp., IPR2017-
`
`00178, Paper 6 at 12-13 (PTAB April 25, 2017).
`
`Moreover, as explained below, other prior art that was not before the
`
`Examiner renders obvious the claimed subject matter of the ’289 Patent on its own
`
`
`5 Unless otherwise indicated, all emphasis is added.
`
`
`
`-10-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`or in combination with Levin and/or Bower. This Petition therefore does not raise
`
`the same or substantially the same prior art or arguments previously considered by
`
`the Examiner. See Unified Patents, Inc. v. Berman, IPR2016-01571, Paper 10 (Dec.
`
`14, 2016) (rejecting patent owner’s 325(d) argument because, although the primary
`
`reference in a two-reference combination had been vetted during prosecution, the
`
`secondary reference had not). Here, Lundahl and Rowland were not before the
`
`Examiner.
`
`D. Claim Construction
`1.
`Level of Ordinary Skill in the Art
`A person of ordinary skill in the art (“POSITA”) at the time of the filing date
`
`of the ’289 Patent would have had at least a Bachelor of Science in electrical
`
`engineering, physics, biomedical engineering, computer engineering, material
`
`science, or a related scientific or engineering field, and at least one year of work or
`
`research experience in optics, optoelectronics, radiometry, photometry, or a related
`
`field. Alternatively, a POSITA in the relevant time frame would have been someone
`
`with at least four years of industry or academic experience in optics, optoelectronics,
`
`radiometry, photometry, or a related field. Ex. 1004 at ¶ 12-16.
`
`Petitioners’ Proposed Constructions
`
`2.
`The claims of the ’289 Patent expired on May 1, 2018. “[T]he Board’s review
`
`of the claims of an expired patent is similar to that of a district court’s review.” In
`
`
`
`-11-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`re Rambus, Inc., 694 F.3d 42, 46 (Fed. Cir. 2012). The Board applies the principle
`
`that claim terms are generally given their ordinary and customary meaning as
`
`understood by a POSITA at the time of the invention. Phillips v. AWH Corp., 415
`
`F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc). In doing so, the Board looks to the
`
`intrinsic evidence of record, examining the claim language, the written description,
`
`and the file history, if in evidence. DePuy Spine, Inc. v. Medtronic Sofamor Danek,
`
`Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17).
`
`The Board should find disavowal of subject matter from claim scope where the
`
`specification distinguishes the subject matter from the present invention and
`
`disparages the same. Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509, 513, 517
`
`(Fed. Cir. 2015) (finding it difficult to “envisage how, in light of the repeated
`
`disparagement of mobile devices with computer modules . . . one could read the
`
`claims of the patents-in-suit to cover such devices.”); Chicago Bd. Options Exch.,
`
`Inc. v. Int’l Sec. Exch., LLC, 677 F.3d 1361, 1372 (Fed. Cir. 2012) (finding
`
`disavowal where the specification goes well beyond expressing the patentee’s
`
`preference for a fully automated exchange over a manual or a partially automated
`
`one and disparages the latter).
`
`
`
`-12-
`
`

`

`Petitioners suggest the following term from the claims of the ’289 Patent
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`requires construction.6
`
`Claims 1–6 and 16–19: Illuminator7
`
`3.
`Petitioners propose that the term “illuminator” be construed as “one or more
`
`light sources generally conforming to a contoured surface.” See Ex. 1001 at
`
`
`6 Petitioners propose, for purposes of this IPR only, that all other claim terms of the
`
`’289 Patent are presumed to take on their ordinary and customary meaning that the
`
`terms would have to a POSITA, and there is no need to resolve any controversy with
`
`respect to these terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
`
`(Fed. Cir. 2011). Petitioners reserve the right to offer, in the District Court
`
`Litigation, specific constructions for any claim terms, consistent with their ordinary
`
`and customary meaning for the aid of the jury. Petitioner’s proposed constructions
`
`and analyses herein are also not a waiver of any argument that certain claim terms
`
`and claims in the ’289 Patent fail to meet the requirements of 35 U.S.C. § 112, and
`
`Petitioner expressly reserves the right to present such argument in the District Court
`
`Litigation.
`
`7 The term “illuminator” appears expressly in claims 1-6 and 16-19 but by virtue of
`
`dependency is also part of claims 7-15; hence, Petitioners’ construction applies to
`
`claims 7-15 as well.
`
`
`
`-13-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Abstract; see also id. at 2:46-47, 2:66-3:13, 4:1-6, Ex. 1004 at ¶ 57-61. In the
`
`Summary of the Invention Section, the specification draws a distinction between the
`
`illuminator of the present invention and flat emitting surfaces (i.e., flat illuminators):
`
`The inverse square law of optics states that the intensity of light from a
`point source received by an object is inversely proportional to the
`square of the distance from the source. Because of this behavior,
`distance from the source is an important variable in all optical systems.
`Thus, in order to achieve uniform facial or scalp irradiation, variations
`in output irradiance with distance must be minimized. A flat emitting
`surface would not deliver a uniform light dose to all contours of the
`face simultaneously because the non-planar facial and scalp surfaces
`could not be placed at a constant distance from the emitting surface.
`To ameliorate this problem, the present invention uses a U-shaped
`emitting surface that more closely follows the contours of the human
`face and scalp, and minimizes lamp to target distance variations which
`in turn minimizes irradiance variations at the target.
`
`Ex. 1001 at 4:29–43. After having linked uniformity of an illuminator to its
`
`suitability for PDT, (id. at 4:18–25), the specification further disparages prior art flat
`
`plane emitting light sources as follows:
`
`Only the more uniform center portion of the tube output is used for
`patient treatment. Another advantage of the [U-shaped] arrangement is
`that uniformity can also be adjusted by varying the lateral spacing of
`the tubes (relative horizontal spacing as shown in FIG. 2). This is
`important since it is necessary to compensate for the fact that the
`output from a flat plane emitting light source drops near the edges.8
`
`Id. at 6:20–27. Here, the Patent Owner is not merely expressing a preference for
`
`contoured illuminators over flat ones. Chicago Bd. Options Exch., 677 F.3d at 1372.
`
`
`8 Unless otherwise indicated, all emphases added.
`
`
`
`-14-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Rather, the Patent Owner repeatedly criticizes flat illuminators and touts its U-
`
`shaped illuminator, which is the only disclosed embodiment, as “necessary” to fix
`
`the problems associated with flat illuminators. It is hard to “envisage how, in light
`
`of the repeated disparagement of [flat illuminators],” one could read the claims of
`
`the ’289 Patent to cover illuminators that do not conform to a contoured surface.
`
`Openwave Sys., Inc., 808 F.3d at 517 (Fed. Cir. 2015). Therefore, the Board should
`
`construe the term “illuminator” to mean “one or more light sources generally
`
`conforming to a contoured surface.” Ex. 1004 at ¶ 57-61.
`
`IV. SUMMARY OF PRIOR ART AND REFERENCES RELIED ON
`The prior art discloses and teaches the claimed subject matter of the ’289
`
`Patent as explained below. All of the references are prior art under 35 U.S.C.
`
`§ 102(b). Rowland and Lundahl were not considered by the Examiner during
`
`prosecution of the ’289 Patent. Levin and Bower were listed in an IDS without
`
`substantive examination, comment, or argument. These prior art references are
`
`directed to the same field as the ’289 Patent (i.e., use of light in medical applications
`
`such as PDT). Ex. 1004 at ¶ 62-73. No secondary considerations support a finding
`
`of nonobviousness.
`
`A. Brief Summary of Rowland (Ex. 1009)
`Like the ’289 Patent, Rowland discloses a light device (i.e., illuminator), for
`
`photodynamic therapy, with substantial uniform illumination. Ex. 1009 at
`
`
`
`-15-
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,216,289
`
`Abstract, 1:1–8. The illuminator uniformly irradiates the area of a surface, collects
`
`light reflected from the area, and scatters it back towards the surface so that
`
`“substantially all of the light supplied to the device is eventually absorbed by the
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`treatment surface.” Id. at Abstract, 14:9–11. As can be seen in Figure 1 below, the
`
`illuminator comprises a hemispherical plastic shell (3) whose inside concave surface