UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`Avation Medical, Inc.,
`Petitioner
`
`v.
`
`EMKinetics, Inc.,
`Patent Owner
`
`_______________________
`
`Case No. PGR2024-00043
`U.S. Patent No. 11,844,943
`________________________
`
`PETITION FOR POST GRANT REVIEW
`OF U.S. PATENT NO. 11,844,943
`__________________________________________________________________
`
`

`

`TABLE OF CONTENTS
`
`INTRODUCTION ............................................................................................... 1
`I.
`COMPLIANCE WITH PGR REQUIREMENTS ........................................... 1
`II.
`Certification (§42.204(a)) ............................................................................ 1
`A.
`Identification of Challenge (§42.204(b)) ..................................................... 2
`B.
`Fee (§42.15(b)) ............................................................................................. 3
`C.
`Service (§42.205) ......................................................................................... 3
`D.
`III. BACKGROUND TECHNOLOGY ................................................................. 4
`A.
`Overactive Bladder (“OAB”) and Incontinence .......................................... 4
`B.
`Treatment of OAB and UI ........................................................................... 4
`IV.
`THE ‘943 PATENT ......................................................................................... 8
`A.
`AIA Status and Eligibility for PGR ............................................................. 8
`B.
`Effective Filing Date ..................................................................................14
`C.
`‘943 Patent Overview .................................................................................17
`D.
`Prosecution History ....................................................................................20
`E.
`Person of Ordinary Skill in the Art (“POSA”) ...........................................20
`V.
`CLAIM CONSTRUCTION ..........................................................................21
`VI.
`EXPLANATION OF UNPATENTABILITY ...............................................21
`A.
`Ground 1: Svihra (Ex.1004) Anticipates Claims 1-3 and 5 .......................21
`B.
`Ground 2: Svihra (Ex.1004) in View of the Knowledge of a
`POSA Renders Obvious Claims 2, 6-13 ..............................................................26
`C.
`Ground 3: Svihra (Ex.1004) in View of Johnson (Ex.1007)
`Renders Obvious Claims 14, 16-18, 27, and 29-31 .............................................35
`D.
`Ground 4: Svihra (Ex.1004) in View of Johnson (Ex.1077)
`and the Knowledge of a POSA Renders Obvious Claims 15, 19-26,
`28, and 32-39 ........................................................................................................40
`E.
`Ground 5: Amarenco (Ex.1005) Anticipates Claims 1-3 and 5 .................44
`F. Ground 6: Amarenco (Ex.1005) in View of the Knowledge of a
`POSA Renders Obvious Claims 4 and 6-13 .........................................................49
`G.
`Ground 7: Amarenco (Ex.1005) in View of Johnson
`(Ex.1007) Renders Obvious Claims 14-16, 18, 27-29, and 31 ............................56
`
`ii
`
`

`

`Ground 8: Amarenco (Ex.1005) in View of Johnson
`H.
`(Ex.1007) and the Knowledge of a POSA Renders Obvious Claims
`17, 19-26, 30, and 32-39 .......................................................................................61
`I. Ground 9: Burnett (Ex.1006) Anticipates Claims 1-3 and 5-13 ...................65
`J. Ground 10: Burnett (Ex.1006) in View of Johnson (Ex.1007)
`and the Knowledge of a POSA Renders Obvious Claims 4 and 14-
`39 70
`K.
`Secondary Considerations ..........................................................................79
`L.
`Ground 11: Claims 1-39 Lack Enablement ...............................................79
`VII. THE BOARD SHOULD NOT EXERCISE ITS DISCRETION
`TO DENY INSTITUTION ......................................................................................82
`A.
`§324(a) .......................................................................................................82
`B.
`§325(d) .......................................................................................................84
`VIII.
`CONCLUSION ..........................................................................................89
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GMBH,
` IPR2019-01469, Paper 6 (Feb. 13, 2020) (precedential) ....................................84
`AK Steel Corp. v. Sollac,
`344 F.3d 1234 (Fed. Cir. 2003) ..................................................................... 80, 81
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) .......................82
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ................................................84
`Brown v. 3M,
`265 F.3d 1349 (Fed. Cir. 2001) ............................................................................22
`Brunswick Corp. v. Volvo Penta of the Americas, LLC,
`IPR2020-01512, Paper 15 (PTAB Mar. 11, 2021) ..............................................79
`Digital Check Corp. d/b/a ST Imaging v. E-Imagedata Corp.,
`IPR2017-00178, Paper 6 (PTAB Apr. 25, 2017) .................................................86
`Droplets, Inc. v. E*TRADE Bank,
`887 F.3d 1309 (Fed. Cir. 2018) ............................................................................16
`Fox Factory, Inc. v. SRAM, LLC,
`IPR2016-01876, Paper 8 (PTAB Apr. 3, 2017) ...................................................86
`In re Vaeck,
`947 F.2d 488 (Fed. Cir. 1991) ..............................................................................79
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) ..............................................................................79
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`481 F.3d 1371 (Fed. Cir. 2007) ............................................................................80
`New World Medical, Inc. v. Microsurgical Tech., Inc.,
`IPR2020-01573, Paper 64 (PTAB March 11, 2022) ............................................. 2
`Sand Revolution, II, LLC v. Cont’l Intermodal Grp. Trucking LLC,
`IPR2019-01393, Paper 24 (PTAB June 16, 2020) ...............................................83
`Zip-Top LLC v. Stasher, Inc.,
`IPR2018-01216, Paper 14 (PTAB Jan. 17, 2019) ................................................86
`
`iv
`
`

`

`Statutes
`35 U.S.C. §102(a)(1) ............................................................................. 17, 21, 44, 65
`35 U.S.C. §102(a)(2) ................................................................................................17
`35 U.S.C. §112 .........................................................................................................21
`35 U.S.C. §120 .........................................................................................................16
`35 U.S.C. §282(b) ....................................................................................................21
`35 U.S.C. §324(a) ....................................................................................................82
`35 U.S.C. §325(d) ............................................................................................ passim
`AIA §3(n)(1), 125 Stat. at 293 .............................................................................8, 13
`AIA §6(f)(2)(A), 125 Stat. at 311 .............................................................................. 8
`Rules
`37 C.F.R. §42.15(b) ................................................................................................... 3
`37 C.F.R. §42.200(b) ........................................................................................ 21, 81
`37 C.F.R. §42.204(a) .................................................................................................. 1
`37 C.F.R. §42.204(b) ................................................................................................. 2
`37 C.F.R. §42.205 ...................................................................................................... 3
`37 C.F.R. §42.24 ........................................................................................................ 1
`37 C.F.R. §42.8(b)(1) ................................................................................................. x
`37 C.F.R. §42.8(b)(2) ................................................................................................. x
`37 C.F.R. §42.8(b)(3) ................................................................................................. x
`37 C.F.R. §42.8(b)(4) ............................................................................................... xi
`
`v
`
`

`

`Exhibit
`No.
`1001
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`1007
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`EXHIBIT LIST
`
`Description
`
`U.S. Patent No. 11,844,943 (“’943 patent”)
`File History of U.S. Patent No. 11,844,943 (“’943 patent file
`history”)
`Declaration of Dr. Brett Wingeier in Support of Petition for Post
`Grant Review of U.S. Patent No. 11,844,943 (“Wingeier Decl.”)
`J. Svihra et al., “Neuromodulative treatment of overactive bladder
`– noninvasive tibial nerve stimulation,” Bratisl Lek Listy
`103(12):480-483 (2002) (“Svihra”)
`G. Amarenco et al., “Urodynamic Effect of Acute Transcutaneous
`Posterior Tibial Nerve Stimulation in Overactive Bladder,” J.
`Urology 169: 2210-2215 (2003) (“Amarenco”)
`U.S. Patent App. Pub. 2008/0306325 to Burnett et al. (“Burnett”)
`Int’l App. Pub. No. WO 2004/108209 to Johnson (“Johnson”)
`G. Willy Davila & Minda Neimark, “The Overactive Bladder:
`Prevalence and Effects on Quality of Life,” Clinical Obstetrics and
`Gynecology 45(1):173-181 (2002) (“Davila”)
`Alan J. Wein & Eric S. Rovner, “Definition and Epidemiology of
`Overactive Bladder,” Urology 60(Suppl 5A):7-12 (2002) (“Wein”)
`Paul Abrams et al., “Overactive Bladder Significantly Affects
`Quality of Life,” The American Journal of Managed Care 6(11,
`Sup.):580-590 (2000) (“Abrams”)
`Neeral Kohli & Peter L. Rosenblatt, “Neuromodulation Techniques
`for the Treatment of the Overactive Bladder,” Clinical Obstetrics
`and Gynecology 45(1):218-232 (2002) (“Kohli”)
`Floor van der Pal et al., “Current opinion on the working
`mechanisms of neuromodulation in the treatment of lower urinary
`tract dysfunction,” Current Opinion in Urology 16(4):261-267
`(2006) (“van der Pal”)
`Francisco Velasco, “Neuromodulation: An Overview,” Archives of
`Medical Research 31(3):232-236 (2000) (“Velasco”)
`
`vi
`
`

`

`Exhibit
`No.
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`1019
`
`1020
`
`1021
`1022
`1023
`
`1024
`
`1025
`1026
`
`1027
`
`Description
`
`J. Groen & J.L.H.R. Bosch, “Neuromodulation techniques in the
`treatment of the overactive bladder,” 87(8):723-731 (2001)
`(“Groen”)
`Marshall L. Stoller, “Afferent Nerve Stimulation for Pelvic Floor
`Dysfunction,” Scientific Non Discussion Poster Session
`16(257):256 (1999) (“Stoller”)
`M. Queralto et al., “Preliminary results of peripheral
`transcutaneous neuromodulation in the treatment of idiopathic fecal
`incontinence,” International Journal of Colorectal Disease
`21(2006):670-672 (2006) (“Queralto”)
`F. Monti et al., “Peripheral neuromodulation using surface
`electrode for treatment of overactive bladder (oab): initial
`experience,” Clinical Neurophysiology 117(2006):243 (2006)
`(“Monti”)
`U. S. Patent No. 10,786,669 to Rajguru et al. (“‘669 patent”)
`U.S. Patent Application No. 15/474,875 to Rajguru (“‘875
`application”)
`U.S. Patent Application No. 16/732,706 to Rajguru et al.
`(“‘706 application”)
`U.S. Patent No. 11,247,053 to Rajguru (“‘053 patent”)
`U.S. Patent No. 6,453,204 to Rhodes (“Rhodes”)
`U.S. Patent Application No. 15/084,356 to Rajguru et al. (“‘356
`application”)
`L. Zhang & D.P. Rabussay, “Clinical evaluation of safety and
`human tolerance of electrical sensation induced by electric fields
`with non-invasive electrodes”,” Bioelectrochemistry 56(1-2):233-
`236 (2002) (“Zhang”)
`U.S. Patent No. 6,341,236 to Osorio et al. (“‘236 patent)
`U.S. Patent App. Pub. No. 2007/0021803 to Deem et al.
`(“'803 application”)
`Katherine N. Moore, “Treatment of Urinary Incontinence in Men
`with Electrical Stimulation: Is Practice Evidence-Based?,” Journal
`vii
`
`

`

`Exhibit
`No.
`
`Description
`
`1028
`
`1029
`1030
`
`1031
`
`1032
`
`1033
`1034
`1035
`
`1036
`1037
`
`1038
`
`of Wound, Ostomy and Continence Nursing 27(1):20-31 (2000)
`(“Moore”)
`Hermie J. Hermens et al., “Development of recommendations for
`SEMG sensors and sensor placement procedures,” Journal of
`Electromyography and Kinesiology 10(5):361-374 (2000)
`(“Hermens”)
`U.S. Patent No. 8,206,312 to Farquhar (“’312 patent”)
`S. Tahseen Hasan et al., “Transcutaneous Electrical Nerve
`Stimulation and Temporary S3 Neuromodulation in Idiopathic
`Detrusor Instability,” The Journal of Urology 155(6):2005-2011
`(1996) (“Hasan”)
`U.S. Patent App. Pub. No. 2005/0075670 to Bengtsson (“’670
`publication”)
`U.S. Patent App. Pub. No. 2007/0276449 to Gunter et al. (“’449
`publication”)
`U.S. Patent No. 7,801,603 to Westlund et al. (“’603 patent”)
`U.S. Patent No. 8,712,546 to Kim et al. (“’546 patent”)
`Micael A. Crary et al., “Biomechanical Correlates of Surface
`Electromyography Signals Obtained During Swallowing by
`Healthy Adults,” Journal of Speech, Language, and Hearing
`Research 49(1):186-193 (2006) (“Crary”)
`U.S. Patent No. 7,206,630 to Tarler (“’630 patent”)
`Stephen A. Koff & Evan J. Kass, “Abdominal Wall
`Electromyography: A Noninvasive Technique To Improve
`Pediatric Urodynamic Accuracy,” The Journal of Urology
`127(4):736-739 (1982) (“Koff”)
`Michael R. van Balken et al., “Posterior Tibial Nerve Stimulation
`as Neuromodulative Treatment of Lower Urinary Tract
`Dysfunction,” The Journal of Urology 166(3):914-918 (2001)
`(“van Balken”)
`
`viii
`
`

`

`Exhibit
`No.
`1039
`
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`1053
`
`Description
`
`J.L.H. Ruud Bosch, “Electrical neuromodulatory therapy in female
`voiding dysfunction,” BJU International 98(s1):43-48 (2006)
`(“Bosch”)
`U.S. Patent No. 11,224,742 to Burnett (“‘742 patent”)
`Edward J. McGuire et al., “Treatment of Motor and Sensory
`Detrusor Instability by Electrical Stimulation,” The Journal of
`Urology 129(1):78-79 (1983) (“McGuire”)
`A.L. Hof, “EMG and Muscle Force: An Introduction,” Human
`Movement Science 3(1-2):119-153 (1984) (“Hof”)
`A Martens De Noordhout et al., “Percutaneous electrical
`stimulation of lumbosacral roots in man,” Journal of Neurology,
`Neurosurgery, and Psychiatry 51(2):174-181 (1988) (“Noordhout”)
`U.S. Patent App. Pub. No. 13/840,936 to Rajguru et al. (“‘936
`application”)
`Int’l App. No. PCT/US2011/052415 (“’415 application”)
`U.S. Provisional App. No. 61/403,680 to Rajguru et al. (‘680
`provisional”)
`U.S. Patent App. No. 12/508,529 to Burnett et al. (“‘529
`application”)
`U.S. Patent App. No. 11/866,329 to Burnett et al. (“‘329
`application”)
`U.S. Provisional App. No. 60/848,720 to Burnett et al. (‘720
`provisional”)
`File History of U.S. Patent No. 11,224,742 (“‘742 patent”/“’742
`patent file history”)
`Avation Medical, Inc. v. EMKinetics, Inc. No. 3:24-cv-01702 (N.D.
`Cal.) First Amended Complaint, Dkt. No. 5
`Notice of Abandonment for U.S. Patent App. No. 12/508,529
`Declaration of Todd R. Tucker
`
`ix
`
`

`

`PETITIONER’S MANDATORY NOTICES
`A. Real Party in Interest (§42.8(b)(1))
`
`Avation Medical, Inc. (“Avation” or Petitioner”) is the real party in interest
`
`of this Petition. No other entity is a real party in interest or a privy of Avation for
`
`this Petition.
`
`B. Related Proceedings (§42.8(b)(2))
`
`On March 19, 2024, Avation filed a complaint against EMKinetics, Inc.
`
`(“EMK” or “PO”) for declaratory judgment of noninfringement of U.S. Patent No.
`
`11,844,943 (“‘943 patent”), U.S. Patent No. 9,002,477 (“‘477 patent”), and U.S.
`
`Patent No. 11,224,742 (“‘742 patent”) in the United States District Court for the
`
`Northern District of California (“NDCA litigation”). See Avation Medical, Inc. v.
`
`EMKinetics, Inc., No. 4:24-cv-01702 (NDCA); Ex.1051. Avation has not filed a
`
`civil action challenging the validity of any claim of the ‘943 patent.
`
`C.
`
`Lead and Backup Counsel (§42.8(b)(3))
`
`Lead Counsel
`
`Todd R. Tucker
`Reg. No. 40,850
`CALFEE, HALTER &
`GRISWOLD LLP
`The Calfee Building
`1405 East Sixth Street
`Cleveland, OH 44114
`P: 216-622-8231
`F: 216-214-0816
`ttucker@calfee.com
`
`Backup Counsel
`
`Kyle T. Deighan
`Reg. No. 75,525
`CALFEE, HALTER &
`GRISWOLD LLP
`The Calfee Building
`1405 East Sixth Street
`Cleveland, OH 44114
`P: 216-622-8551
`F: 216-214-0816
`kdeighan@calfee.com
`x
`
`

`

`Brynna M. W. Wasserman
`Reg. No. 76,700
`CALFEE, HALTER &
`GRISWOLD LLP
`The Calfee Building
`1405 East Sixth Street
`Cleveland, OH 44114
`P: 216-622-8661
`F: 216-214-0816
`bwasserman@calfee.com
`
`D.
`
`Service Information (§42.8(b)(4))
`
`Petitioner consents to electronic service by email at the email addresses
`
`listed above and ipdocket@calfee.com.
`
`xi
`
`

`

`I.
`
`INTRODUCTION
`The ‘943 patent claims methods of treating overactive bladder (“OAB”) or
`
`incontinence using well-known transdermal electrical stimulation therapy. The
`
`prior art, however, described treatment of OAB and incontinence using
`
`noninvasive electrostimulation techniques well before October 2006, the earliest
`
`claimed priority date of the ‘943 patent. Most notably, Svihra—published in 2002
`
`and not considered during the ‘943 patent’s prosecution—describes treating OAB
`
`patients using noninvasive electrical stimulation targeting the posterior tibial nerve
`
`(“PTN”). Various additional prior art references described similar treatments well
`
`before 2006. Moreover, the claims of the ‘943 patent are also invalid for lack of
`
`enablement because the specification teaches against key aspects of the claimed
`
`invention. Because the evidence demonstrates that claims 1-39 of the ‘943 patent
`
`(“Challenged Claims”) are invalid, the Board should institute post-grant review
`
`(“PGR”) and find the claims of the ‘943 patent unpatentable.
`
`II.
`
`COMPLIANCE WITH PGR REQUIREMENTS
`A.
`Certification (§42.204(a))
`Petitioner certifies that if the ’943 patent is an AIA patent (see §IV.A), it is
`
`available for PGR. Petitioner is not barred or estopped from requesting PGR on the
`
`Challenged Claims on the grounds below. Petitioner and its privies have not filed a
`
`civil action challenging the validity of any claim of the ’943 patent. This petition is
`
`timely filed because: (a) Petitioner has not been served with a complaint alleging
`1
`
`

`

`infringement of the ‘943 patent as of this petition’s filing; and (b) it is filed within
`
`9 months of the patent’s issuance (i.e., December 19, 2023).
`
`Identification of Challenge (§42.204(b))
`B.
`Petitioner requests cancellation of the Challenged Claims1 based on the
`
`following Grounds:
`
`Ground Claims
`
`Description
`
`1
`
`2
`
`3
`
`4
`
`5
`
`1, 3-5
`
`2, 6-13
`
`Anticipated by Svihra (Ex.1004)
`
`Obvious over Svihra (Ex.1004) and Knowledge of
`
`POSA2
`
`14, 16-18, 27,
`
`Obvious over Svihra (Ex.1004) and Johnson
`
`29-31
`
`(Ex.1007)
`
`15, 19-26, 28,
`
`Obvious over Svihra (Ex.1004) and Johnson
`
`32-39
`
`1-3, 5
`
`(Ex.1007) and Knowledge of POSA
`
`Anticipated by Amarenco (Ex.1005)
`
`1 The Challenged Claims are reproduced in the Claim Appendix below.
`
`2 See New World Medical, Inc. v. Microsurgical Tech., Inc., IPR2020-01573, Paper
`
`64 at 10 (PTAB March 11, 2022) (analyzing obviousness “is always from the
`
`perspective of an ordinarily skilled artisan and one must consider knowledge
`
`generally available to one of ordinary skill in the art.”).
`
`2
`
`

`

`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`4, 6-13
`
`Obvious over Amarenco (Ex.1005) and Knowledge
`
`of POSA
`
`14-16, 18,
`
`Obvious over Amarenco (Ex.1005) and Johnson
`
`27-29, 31
`
`(Ex.1007)
`
`17, 19-26, 30,
`
`Obvious over Amarenco (Ex.1005) and Johnson
`
`32-39
`
`(Ex.1007) and Knowledge of POSA
`
`1-3, 5-13
`
`Anticipated by Burnett (Ex.1006)
`
`4, 14-39
`
`Obvious over Burnett (Ex.1006) and Johnson
`
`(Ex.1007) and Knowledge of POSA
`
`1-39
`
`Lack of enablement under 35 U.S.C. §112
`
`Petitioner’s challenges are supported by the testimony of Dr. Brett Wingier,
`
`an expert in biomedical engineering and stimulation therapy with over 20 years of
`
`experience. Ex.1003, ¶¶6-13.
`
`Fee (§42.15(b))
`C.
`The Director is authorized to charge applicable fees to Deposit Account
`
`03-0172.
`
`Service (§42.205)
`D.
`Proof of service is provided below.
`
`3
`
`

`

`III. BACKGROUND TECHNOLOGY
`A.
`Overactive Bladder (“OAB”) and Incontinence
`OAB is a condition that encompasses a range of irritative bladder filling and
`
`storage symptoms suggestive of lower urinary tract dysfunction. Ex.1008, 173;
`
`Ex.1009, 7. In the early 2000s, OAB was defined as “urgency, with or without urge
`
`incontinence, usually with frequency and nocturia.” Ex.1009, 7. “Urgency” refers
`
`to a strong desire to void (i.e., urinate), “frequency” refers to a need to urinate on
`
`an abnormally frequent basis (including frequent urination at night, referred to as
`
`“nocturia”), and “urge incontinence” refers to urine loss preceded by urgency.
`
`Ex.1008, 173. In the early 2000’s, it was estimated 17-33 million people in the
`
`U.S. were affected by OAB. Ex.1010, 580; Ex.1009, 10; Ex.1003, ¶¶35-36.
`
`Treatment of OAB and UI
`B.
`Well before 2006, various approaches were used to treat OAB and
`
`incontinence, including behavioral modifications, pharmacological therapies,
`
`surgery, and neuromodulation. Ex.1011, 219; Ex.1001, 2:35-3:16. Behavioral
`
`therapies required adherence to routines, which patients found unattractive. Id.
`
`Pharmacological interventions often caused unacceptable side effects. Id. Surgery
`
`was invasive, expensive, and only used when other treatments failed. Id. Due to
`
`these limitations, neuromodulation techniques were developed to treat OAB and
`
`incontinence. Ex.1011, 220; Ex.1003, ¶¶37-38.
`
`4
`
`

`

`Neuromodulation refers to therapeutic techniques involving influencing one
`
`neural pathway to modulate activity in another. Ex.1012, 261. By the early 2000’s,
`
`neuromodulation was used to treat various conditions. Ex.1013, 232. Electrical
`
`stimulation was one common form of neuromodulation used to treat OAB and UI.
`
`Ex.1003, ¶¶39-40.
`
`Sacral nerve stimulation (“SNS”) was a well-known technique for treating
`
`OAB and incontinence. Ex.1014, 726. SNS involved implanting a pulse generator
`
`and electrode to stimulate nerves emanating from the sacral region of the spinal
`
`cord, which communicate with muscles controlling urination. Id. While effective,
`
`the technique was invasive and costly. Id., 727-28; Ex.1001, 2:62-3:4; Ex.1003,
`
`¶41.
`
`Percutaneous PTN stimulation (“PTNS”) (also called Stoller Afferent Nerve
`
`Stimulation (“SANS”)) was another known electrostimulation technique. Ex.1014,
`
`727; Ex.1001, 3:5-16. A needle connected to an electrical stimulator was inserted
`
`near the medial malleolus (i.e., the ankle) to stimulate the PTN. Id.
`
`5
`
`

`

`Ex.1014 (Groen), Fig. 4, 728
`“Treatment usually takes place weekly for 10-12 weeks over 20-30 min.” Id., 727.
`
`Many studies demonstrated safety and efficacy of SANS. Id., 727-28; Ex.1001,
`
`3:5-16. Stoller, for example, “described an 81% clinical success rate.” Ex.1015,
`
`256. PTNS was, however, invasive given the need to penetrate patients’ skin.
`
`Ex.1003, ¶¶42-43.
`
`Noninvasive electrostimulation techniques were also known well before
`
`2006. Ex.1003, ¶44. Transcutaneous electrical nerve stimulation (“TENS”),
`
`commonly used to treat various conditions such as pain, was investigated for
`
`OAB/incontinence treatment. Ex.1014, 725-26. In TENS, surface electrodes were
`
`placed on patients’ skin overlying areas desired for stimulation, including the PTN.
`
`Id., 724. Many studies showed positive results in treating OAB/incontinence. Id.,
`
`724-25.
`
`6
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`

`

`For example, McGuire reported on noninvasive PTN electrostimulation in
`
`1983. Ex.1003, ¶45. McGuire’s technique involved applying current via an
`
`electrode “applied by a stick-on electrocardiograph-type electrode with a foam
`
`backing” to the common peroneal nerve or PTN. Ex.1041, 78-79. McGuire stated
`
`“[t]his electrode placement, coupled with a commercially available transcutaneous
`
`electrical nerve stimulator used for the control of pain, provides a reasonable
`
`method to inhibit detrusor activity.” Id., 79.
`
`In the early 2000’s, studies using similar noninvasive techniques were
`
`published. Svihra “tested the effectiveness of modified superficial Stoller’s afferent
`
`nerve stimulation (SANS)” in OAB patients. Ex.1004, 480, 481. Svihra attached
`
`electrodes “behind the medial ankle of the left lower extremity” and applied
`
`electric stimulation targeting the PTN for 30 minutes/week. Id. Svihra concluded
`
`the technique “is acceptable and safe conservative treatment in case of [OAB].”
`
`Id., 480, 482; Ex.1003, ¶46.
`
`Amarenco published a study on “left [PTN] stimulation using a surface self-
`
`adhesive electrode on the ankle skin behind the internal malleolus” in patients
`
`“presenting with symptoms (urge incontinence and frequency) secondary to
`
`[OAB].” Ex.1005, 2210. Amarenco’s results “suggest an objective acute effect of
`
`[PTN] stimulation on urodynamic parameters. Improved bladder overactivity is an
`
`7
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`

`

`encouraging argument to propose [PTN] stimulation as a noninvasive treatment
`
`modality in clinical practice.” Id.; Ex.1003, ¶47.
`
`Long before 2006, published reports such as McGuire, Svihra, and
`
`Amarenco, among many others, demonstrated that noninvasively applying PTN
`
`electrostimulation was a well-known and effective OAB/incontinence treatment.
`
`See also Ex.1016, 670; Ex.1017, 243; Ex.1003,¶48.
`
`IV. THE ‘943 PATENT
`A.
`AIA Status and Eligibility for PGR
`Patents described in AIA §3(n)(1) are eligible for PGR. AIA §6(f)(2)(A),
`
`125 Stat. at 311. According to §3(n)(1), AIA patents include:
`
`any application for patent, and [] any patent issuing thereon, that
`contains or contained at any time—
`
`(A) a claim to a claimed invention that has an effective filing
`date as defined in section 100(i) of title 35, United States Code,
`that is on or after the effective date [i.e., March 16, 2013]; or
`
`(B) a specific reference under section 120, 121, or 365(c) of
`title 35, United States Code, to any patent or application that
`contains or contained at any time such a claim.
`
`AIA §3(n)(1), 125 Stat. at 293. For multiple reasons, the ‘943 patent is an AIA
`
`patent and is eligible for PGR.
`
`8
`
`

`

`First, the ‘943 patent contains a specific reference to patents and/or
`
`applications that “contain[] or contained at any time” claims with an effective
`
`filing date “after the [AIA] effective date,” i.e., March 16, 2013. The ‘943 patent
`
`purports to be a continuation of the ‘706 application (issued as ‘053 patent), which
`
`is a continuation of the ‘875 application (issued as ‘669 patent). Ex.1001, [63], 1:8-
`
`30. The ‘875 application is a CIP of the ‘356 application filed March 29, 2016. Id.
`
`The ‘356 application is a continuation of the ‘936 application filed March 15,
`
`2013. Id. The ‘936 application is a CIP of the ‘415 PCT filed Sept. 20, 2011, which
`
`claims priority to the ‘680 provisional filed Sept. 20, 2010. Id. The ‘875
`
`application also purports to be a CIP of the ‘529 application filed on July 23, 2009,
`
`which is a CIP of the ‘329 application filed Oct. 2, 2007, which claims priority to
`
`the ‘720 provisional filed Oct. 2, 2006. Id., [63], 1:8-30. At least several of these
`
`patents/applications to which the ‘943 patent contains a specific reference
`
`“contain[] or contained at any time” claims with an effective filing date after
`
`March 16, 2013.
`
`For example, the ‘669 patent contains claims with an effective filing date no
`
`earlier than March 30, 2017, the filing date of the ‘875 application. Claim 1 of the
`
`‘669 patent recites “a method for providing transdermal electrical stimulation
`
`therapy to a subject for treating tremors,” including “positioning a stimulator
`
`electrode over a skin surface overlying a target nerve or tissue which extends
`
`9
`
`

`

`through a hand of the subject.” Ex.1018, Cl.1. Claim 19, which depends from
`
`claim 1 by way of claim 18, further recites “the at least two electrodes are
`
`positioned to stimulate an Ulnar or Median nerve.” Id., cls.18-19. There is no
`
`written description support or enablement for the features of claims 1 or 19 in any
`
`of the applications to which the ‘669 patent claims benefit/priority. If mentioned at
`
`all, the prior applications only mentions the term “tremor” once in a list of over
`
`100 “ailments” that purportedly may be treated with the invention. Ex.1023,
`
`[0121]; Ex.1044, [0121]; Ex.1045, [0119]; Ex.1047, [0111]; Ex.1048, [0090];
`
`Ex.1049, [0031]. The prior applications never mention the terms “ulnar” or
`
`“median” nerve whatsoever, let alone to treat tremors by stimulating the
`
`ulnar/median nerves specifically. The first application containing any disclosure
`
`even arguably relevant to electrostimulation of the ulnar/median nerves is the ‘875
`
`application filed March 30, 2017, issued as the ‘669 patent. No prior applications
`
`to which the ‘669 patent claims benefit/priority supports claims 1 and 19 regarding
`
`treatment of tremors by stimulating a nerve extending through the hand or treating
`
`tremors by stimulating the ulnar or median nerves.
`
`Moreover, listed below are various additional examples of
`
`patents/applications to which the ‘943 patent contains a specific reference that
`
`“contain[] or contained at any time” a claim with an effective filing date after
`
`March 16, 2013.
`
`10
`
`

`

` The ‘875 application (which issued as the ‘669 patent) “contained”
`
`claims with an effective filing date no earlier than March 30, 2017, the
`
`filing date of the ‘875 application itself. The originally-filed claims of
`
`the ‘875 application included claim 1 (including the limitations
`
`“delivering electrical stimulation . . . to a target nerve or tissue in the
`
`hand” and “wherein the pulses generated . . . include pulses of a first
`
`amplitude and pulse of a second amplitude, where the first amplitude
`
`is different from the second amplitude”) and claim 21 (including the
`
`limitation “wherein the pain felt by the subject is migraine pain”).
`
`Ex.1019, 101-03. None of the applications to which the ‘875
`
`application claims benefit/priority provides written description
`
`support or enablement for delivering electrical stimulation at pulses of
`
`a first amplitude and a different second amplitude, or of treating pain
`
`caused by a migraine by electrically stimulating nerves/tissues within
`
`the hand.
`
` The ‘706 application (which issued as the ‘053 patent) “contained”
`
`claims with an effective filing date no earlier than March 30, 2017, the
`
`filing date of the ‘875 application. The originally-filed claims of the
`
`‘706 application included claim 1 (which included limitations
`
`“wherein the pulses generated . . . include pulses of a first amplitude
`
`11
`
`

`

`and pulse of a second amplitude, where the first amplitude is different
`
`from the second amplitude,” “a pulse width of 200 microseconds,”
`
`and “five pulses at the fist amplitude followed by five pulses at the
`
`second amplitude”), claim 11 (which specified positioning the
`
`electrode “in proximity to an ulnar nerve”), and claim 12 (which
`
`specified positioning the electrode “in proximity to a median nerve”).
`
`Ex.1020, 101-02. None of the applications to which the ‘706
`
`application claims benefit/priority prior to the ‘875 application
`
`provides written description support or enablement for any of the
`
`specific pulse-parameter limitations of original claim 1, or for
`
`positioning an electrode in proximity to an ulnar or median nerve as
`
`specified in original claims 11-12.
`
` The ‘053 patent “contains” claims with an effective filing date no
`
`earlier than March 30, 2017, the filing date of the ‘875 application.
`
`The issued claims of the ‘053 patent include claim 1 (which specifies
`
`treating migraines by positioning an electrode over a skin surface
`
`overlying a target nerve or tissue extending through a subject’s hand).
`
`Ex.1021, cl.1. As discussed above regarding the originally-filed
`
`claims of the ‘875 application, none of the applications to which the
`
`‘053 patent claims benefit/priority prior to the ‘875 application
`
`12
`
`

`

`provides written description support or enablement for treating pain
`
`caused by migraines by electrically stimulating nerves and tissues
`
`within the hand.
`
`A