throbber
ApprovedforusethroughO?JJ;~~\~lJ: 3766
`Receipt date: 10/17/2011
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid
`0MB control number.
`
`Complete if Known
`Aoolication Number
`13/005,005
`Filinq Date
`January 12, 2011
`Simon
`First Named Inventor
`Art Unit
`tbd
`Examiner Name
`tbd
`Attorney Docket Number
`ELEC-33
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`I 1
`I OF
`16
`Sheet
`
`Exa
`mine
`r lnts
`
`Cite
`No.
`
`1 .
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`11 .
`
`12.
`
`13.
`
`14.
`
`15.
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when
`appropriate), title of the item (book, magazine, journal, serial, symposium,
`catalog, etc.), date, pages, volume/issue number(s), publisher, city and/or
`country where published.
`ALBERT, et al. Deep brain stimulation, vagal nerve stimulation and transcranial
`stimulation: An overview of stimulation parameters and neurotransmitter release.
`Neuroscience and Biobehavioral Reviews 33 (2009) 1042-1060.
`AL-MUTAWALY, et al. The Effects of Pulse Configuration on Magnetic Stimulation.
`Journal of Clinical Neurophysioloay 20(5):361-370, 2003.
`AMOR, et al. Inflammation in neurodegenerative diseases. Immunology, 129 (2010),
`154-169.
`ANDERSON, et al. Decreasing Procedural Pain Over Time of Left Prefrontal rTMS
`forDepression: Initial Results from the Open-Label Phase of a Multisite Trial (OPT-
`TMS). Brain Stimul. 2009 April 1; 2(2): 88-92.
`AZIZ et al. Magnetic Stimulation of Efferent Neural Pathways to the Human
`OesophaQus. Gut 33: S53-S70 (Poster Session F218) (1992).
`AZIZ, Q. et al. Esophageal myoelectric responses to magnetic stimulation of the
`human cortex and the extracranial vagus nerve. Am. J. Physiol. 267 (Gastrointest.
`Liver Physiol. 30): G827-G835, 1994.
`BASHAM, et al. Magnetic Stimulation of Neural Tissue: Techniques and System
`Design. pp 293- 352, In: Implantable Neural Prostheses 1, Devices and Applications,
`D. Zhou and E. Greenbaum, eds., New York: SprinQer (2009).
`BORCKARDT, et al. Reducing Pain and Unpleasantness During Repetitive
`Transcranial Maanetic Stimulation. Journal of ECT 2006; 22:259-264.
`BOWTELL et al. Analytic Calculations of the E-Fields Induced by Time-Varying
`Magnetic Fields Generated by Cylindrical Gradient Coils. Magnetic Resonance in
`Medicine 44:782-790 (2000).
`BREDESEN, et al. Cell death in the nervous system. Nature 443(2006): 796-802.
`CAMERON, MH, et al. Transcutaneous Electrical Nerve Stimulation (TENS) for
`dementia. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.:
`CD004032. (2009 update).
`CARBUNARU et al. Toroidal coil models for transcutaneous magnetic stimulation of
`nerves. IEEE Transactions on Biomedical Engineering. 48 (No. 4, April 2001 ): 434-
`441.
`FAIERSTEIN et al. Coil Designs for Localized and Efficient Magnetic Stimulation of
`the Nervous System. Ph.D. Dissertation, Department of Biomedical Engineering,
`Case Western Reserve, May, 1999. (UMI Microform Number: 9940153, UMI
`Company, Ann Arbor Ml).
`CHAE et al. A review of functional neuroimaging studies of vagus nerve stimulation
`(VNS). Journal of Psychiatric Research 37 (2003) 443-455.
`CHANG et al. Prevalence and risk factors for postoperative delirium in a
`cardiovascular intensive care unit. American Journal of Critical Care. 2008;17:567-
`
`Examiner
`Date
`01/01/2013
`iJessica Sarcione/
`Si nature
`Considered
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by CFR 1 .98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`US PTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case.
`Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`
`THISADDRA8EJ:Er-'{~EE!SSt:~J1~~11~Stl~W~t5Fs151~LbJED THROUGH. /J.S./
`
`LUMENIS EX1056
`Page 1
`
`

`

`ApprovedforusethroughO?JJ;~~\~lJ: 3766
`Receipt date: 10/17/2011
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid
`0MB control number.
`
`Complete if Known
`Aoolication Number
`13/005,005
`Filinq Date
`January 12, 2011
`Simon
`First Named Inventor
`Art Unit
`tbd
`Examiner Name
`tbd
`Attorney Docket Number
`ELEC-33
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`I 2
`I OF
`16
`Sheet
`
`16.
`17.
`
`18.
`
`19.
`20.
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`30.
`
`31.
`
`32.
`
`33.
`
`34.
`
`35.
`
`575.
`CHOILEAIN et al. Cell response to suraerv. Arch Sura 2006; 141 :1132-40.
`CHOU, Michael A. et al. Tumor Necrosis Factor Inhibition Reduces the Incidence of
`Alzheimer's Disease in Rheumatoid Arthritis Patients. Program abstracts of the
`American College of Rheumatology/ Association of Rheumatology Health
`Professionals Scientific Meeting, November 8, 2010, Atlanta GA, Presentation No.
`640.
`CLARK et al. The roles of TNF in brain dysfunction and disease. Pharmacology &
`Therapeutics , 128 (Issue 3, December 2010): 519-548.
`COMPSTON et al. Multiple sclerosis. Lancet 372 (9648, October 2008): 1502-1517.
`COTELLI M et al. Transcranial magnetic stimulation improves naming in Alzheimer
`disease patients at different stages of cognitive decline. Eur J Neural. 15(12,
`2008) :1286-92.
`data sheet for Right Guard Clear Gel from Dial Corporation, 15501 N. Dial Boulevard,
`Scottsdale AZ 85260
`data sheet for Tecophlic from The Lubrizol Corporation, 29400 Lakeland Boulevard,
`Wickliffe, Ohio 44092.
`DAVEY. Magnetic Stimulation Coil and Circuit Design. IEEE Transactions on
`Biomedical Engineering, Vol. 47 (No. 11, Nov. 2000): 1493-1499.
`HSU KH, Nagarajan SS, Durand OM. Analysis of efficiency of magnetic stimulation.
`IEEE Trans Biomed Ena. 2003 Nov; 50 (11) :1276-85.
`DELEGGE. Neurodegeneration and Inflammation. Nutrition in Clinical Practice 23
`(2008) :35-41 ;
`DELITTO et al. A Study of Discomfort with Electrical Stimulation. Phys. Ther. 1992;
`72:410-424.
`ESSELLE et al. Neural stimulation with magnetic fields: Analysis of induced electric
`fields, IEEE Trans. Biomed. Eng., 39 (July 1992), pp. 693-700.
`MARROSU et al. Vagal nerve stimulation improves cerebellar tremor and dysphagia
`in multiple sclerosis. Multiple Sclerosis 2007; 13: 1200-1202.
`FEYNMAN et al. The Feynman Lectures on Physics. Volume II. Addison-Wesley
`Publ. Co. (Readina MA, 1964), paae 15-15.
`FRICCHIONE et al. Postoperative Delirium. Am J Psychiatry 165 (7, July 2008): 803-
`812.
`GEORGE et al. Mechanisms of action of vagus nerve stimulation (VNS). Clinical
`Neuroscience Research 4 (2004) 71-79.
`GLASS et al. Mechanisms Underlying Inflammation in Neurodegeneration. Cell 140
`(2010): 918-934.
`GREEN et al. Conducting polymer-hydrogels for medical electrode applications. Sci.
`Technol. Adv. Mater. 11 (2010) 014107 (13pp).
`GRIFFIN. Perispinal etanercept: Potential as an Alzheimer therapeutic. Journal of
`Neuroinflammation 2008, 5:3.
`TOBINICK. Tumour Necrosis Factor Modulation for Treatment of Alzheimer's Disease
`Rationale and Current Evidence. CNS Druas 2009; 23 (9): 713-725.
`
`Examiner
`Date
`/Jessica Sarcione/
`01/0i/2013
`Si nature
`Considered
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by CFR 1 .98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`US PTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case.
`Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`
`THISADDRA8EJ:Er-'{~EE!SSt:~J1~~11~Stl~W~t5Fs151~LbJED THROUGH. /J.S./
`
`LUMENIS EX1056
`Page 2
`
`

`

`ApprovedforusethroughO?JJ;~~\~lJ: 3766
`Receipt date: 10/17/2011
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid
`0MB control number.
`
`Complete if Known
`Aoolication Number
`13/005,005
`Filinq Date
`January 12, 2011
`Simon
`First Named Inventor
`Art Unit
`tbd
`Examiner Name
`tbd
`Attorney Docket Number
`ELEC-33
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`I 3
`I OF
`16
`Sheet
`
`36.
`
`37.
`
`38.
`
`39.
`
`40.
`
`41.
`
`42.
`
`43.
`
`44.
`
`45.
`
`46.
`
`47.
`
`48.
`
`49.
`
`50.
`
`51.
`
`52.
`
`53.
`
`54.
`
`55.
`
`GROVES et al. Vagal nerve stimulation: a review of its applications and potential
`mechanisms that mediate its clinical effects. Neurosci Biobehav Rev (2005) 29:493-
`500.
`GUSE B et al. Cognitive effects of high-frequency repetitive transcranial magnetic
`stimulation: a systematic review. J Neural Transm. 117(1,2010):105-22.
`HAASS. Initiation and propagation of neurodegeneration. Nature Medicine
`16(11,2010): 1201-1204;
`HAFLER DA, Kent SC, Pietrusewicz MJ, Khoury SJ, Weiner HL and Fukaura H. Oral
`administration of myelin induces antigen-specific TGF-beta 1 secreting T cells in
`patients with multiple sclerosis. Ann N Y Acad Sci 1997;56:120-131.
`HAKKINEN et al. Which structures are sensitive to painful transcranial stimulation?
`Electromyogr. clin. Neurophysiol. 1995, 35:377-383.
`HALA. Pathophysiology of postoperative delirium: Systemic inflammation as a
`response to surgical trauma causes diffuse microcirculatory impairment. Medical
`Hypotheses (2007) 68, 194-196.
`HAM DY et al. Long-term reorganization of human motor cortex driven by short-term
`sensory stimulation. Nature Neuroscience 1 (issue 1, May 1998) :64-68.
`HAMDY et al. Cranial nerve modulation of human cortical swallowing motor
`pathways. Am. J. Physiol. 272 (Gastrointest. Liver Physiol. 35): G802-G808, 1997;
`HEIM BURG et al. On soliton propagation in biomembranes and nerves. PNAS vol.
`102 (no. 28, July 12, 2005): 9790-9795.
`HOVEY et al. The Guide to Magnetic Stimulation, The Magstim Company Ltd, Spring
`Gardens, Whitland, Carmarthenshire, SA34 OHR, United Kinadom, 2006.
`HU et al. Inflammation: a bridge between postoperative cognitive dysfunction and
`Alzheimer's disease. Med Hypotheses. 201 0 Apr;74(4):722-4.
`JOHNSTON et al. Cytokines and the immunomodulatory function of the vagus nerve.
`British Journal of Anaesthesia 102(4,2009): 453-462.
`KETELAER et al. Percutaneous epidural dorsal cord stimulation in multiple sclerosis.
`Acta Neurochiruraica 49 (1979): 95-101.
`KHEDR et al. Aref Electrophysiological study of vocal-fold mobility disorders using a
`maanetic stimulator. European Journal of Neuroloqy 2002, 9: 259-267.
`KHEDR et al. Dysphagia and hemispheric stroke: A transcranial magnetic study.
`Neurophysioloaie Cliniaue/Clinical Neurophysioloay (2008) 38, 235-242).
`KIM YS, et al. major player in the brain inflammation: their roles in the pathogenesis
`of Parkinson's disease. Exp Mol Med 38(2006): 333-347.
`KRAUSE P. et al. FES cycling reduces spastic muscle tone in a patient with multiple
`sclerosis. NeuroRehabilitation. 2007;22(4):335-7.
`LANG AE. Et al. Parkinson's disease. Second of two parts. N Engl J Med 339 (No.
`16, 1998): 1130-1143.
`LEVY, et al. Therapeutic Potential of Neurotrophic Factors in Neurodegenerative
`Diseases. Biodruas 2005; 19 (2): 97-127.
`LIBOFF. Signal shapes in electromagnetic therapies: a primer. pp. 17-37 in:
`Bioelectromaanetic Medicine (Paul J. Rosch and Marko S. Markov, eds.). New York:
`
`Examiner
`/Jessica Sarcione/
`Si nature
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by CFR 1 .98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`US PTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case.
`Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`
`Date
`Considered 01/01/2013
`
`THISADDRA8EJ:Er-'{~EE!SSt:~J1~~11~Stl~W~t5Fs151~LbJED THROUGH. /J.S./
`
`LUMENIS EX1056
`Page 3
`
`

`

`ApprovedforusethroughO?JJ;~~\~lJ: 3766
`Receipt date: 10/17/2011
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid
`0MB control number.
`
`Complete if Known
`Aoolication Number
`13/005,005
`Filinq Date
`January 12, 2011
`Simon
`First Named Inventor
`Art Unit
`tbd
`Examiner Name
`tbd
`Attorney Docket Number
`ELEC-33
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`I 4
`I OF
`16
`Sheet
`
`56.
`
`57.
`
`58.
`
`59.
`
`60.
`
`61.
`
`62.
`
`63.
`
`64.
`
`65.
`
`66.
`
`67.
`
`68.
`
`69.
`
`70.
`
`71.
`
`72.
`
`73.
`
`Marcel Dekker (2004).
`LIN et al. Mitochondrial dysfunction and oxidative stress in neurodegenerative
`diseases. Nature 443(2006): 787-795.
`LIU et al. On the Induced Electric Field Gradients in the Human Body for Magnetic
`Stimulation by Gradient Coils in MRI, IEEE Transactions on Biomedical Engineering
`50: (No. 7, July 2003) pp. 804-815.
`LO. Degeneration and repair in central nervous system disease. Nature Medicine
`16(11,2010) :1205-1209.
`MAKAR et al. Brain derived neurotrophic factor treatment reduces inflammation and
`apoptosis in experimental allergic encephalomyelitis. J Neural Sci. 270(1-2,2008) :70-
`6.
`MAN et al. Magnetic stimulation for the measurement of respiratory and skeletal
`muscle function. Eur Respir J 2004; 24: 846-860.
`MANGIALASCHE F. et al. Alzheimer disease: clinical trials and drug development.
`Lancet Neural. 2010 Jul;9(7) :702-16.
`MARROSU, A. et al. Vagal nerve stimulation effects on cerebellar tremor in multiple
`sclerosis. Neuroloav 65 (2005): 490.
`McCOY et al. TNF signaling inhibition in the CNS: implications for normal brain
`function and neurodegenerative disease. Journal of Neuroinflammation 2008, 5:45.
`MERRILL CA et al. Vagus nerve stimulation in patients with Alzheimer's disease:
`Additional follow-up results of a pilot study through 1 year. J Clin Psychiatry. 2006
`Auq ;67(8) :1171-8.
`MIRSHAFIEY A et al. TGF-beta as a promising option in the treatment of multiple
`sclerosis. Neuropharmacology 56(6-7, 2009) :929-36.
`NILSSON et al. Determining the site of stimulation during magnetic stimulation of the
`peripheral nerve, Electroencephalographs and clinical neurophysiology. vol 85, pp.
`253-264, 1992.
`OLNEY et al. A comparison of magnetic and electric stimulation of peripheral nerves.
`Muscle Nerve 1990:13:957-963.
`PALOP et al. A network dysfunction perspective on neurodegenerative diseases.
`Nature 443(2006): 768-773.
`patent application JP2008/081479A (Publication No. JP2009233024A), entitled Vagus
`nerve stimulation system, to YOSHIHOTO
`PECK. IADRD: Pilot Study of Thalidomide for Alzheimer's Disease Fails to Detect
`Cognitive Benefit but Finds Effect on TNF-alpha. Doctor's Guide Global Edition, July
`26, 2002.
`PEREA et al. GLIA modulates synaptic transmission. Brain Research Reviews. 63
`(Issues 1-2, May 2010) :93-102.
`PERRY. The influence of systemic inflammation on inflammation in the brain:
`implications for chronic neurodegenerative disease. Brain, Behavior, and Immunity 18
`(2004): 407-413.
`POLAK T. et al. Far field potentials from brain stem after transcutaneous vagus nerve
`stimulation: optimization of stimulation and recordinq parameters. J Neural Transm.
`
`Date
`Examiner
`/Jessica Sarcione/
`Considered 01/01/2013
`Si nature
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by CFR 1 .98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`US PTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case.
`Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`
`THISADDRA8EJ:Er-'{~EE!SSt:~J1~~11~Stl~W~t5Fs151~LbJED THROUGH. /J.S./
`
`LUMENIS EX1056
`Page 4
`
`

`

`ApprovedforusethroughO?JJ;~~\~lJ: 3766
`Receipt date: 10/17/2011
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid
`0MB control number.
`
`Complete if Known
`Aoolication Number
`13/005,005
`Filinq Date
`January 12, 2011
`Simon
`First Named Inventor
`Art Unit
`tbd
`Examiner Name
`tbd
`Attorney Docket Number
`ELEC-33
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`I s
`I OF
`16
`Sheet
`
`2009 Oct; 116(10):1237-42.
`PROLO et al. Putative Neurolmmune Mechanisms in Alzheimer's Disease:
`Modulation by Cholinergic Anti-Inflammatory Reflex (GAIR). International Journal of
`lntearative Bioloay 2007, Vol 1 (No. 2):88-95.
`RAFFERTY et al. Magnetic phrenic nerve stimulation to assess diaphragm function in
`children following liver transplantation. Pediatr Grit Care Med 2001, 2:122-126.
`RAMAIAH et al. Postoperative Cognitive Dysfunction in the Elderly. Anesthesiology
`Clin 27(2009): 485-496.
`RASMUSSEN. Postoperative cognitive dysfunction: Incidence and prevention. Best
`Practice & Research Clinical Anaesthesioloay 20(2006, No. 2): 315-330.
`RATTAY. The basic mechanism for the electrical stimulation of the nervous system.
`Neuroscience Vol. 89, No. 2, pp. 335-346, 1999.
`RUDOLPH et al. Chemokines are Associated with Delirium after Cardiac Surgery. J
`Gerontol A Biol Sci Med Sci. 2008 February 63(2): 184-189.
`RUD RA A. et al. Postoperative delirium. Indian J Grit Care Med 2006;10:235-40.
`SAUER et al. Postoperative cognitive decline. J Anesth (2009) 23:256-259.
`SAWICKI et al. Mathematical Modelling of Vagus Nerve Stimulation. pp. 92-97 in:
`Krawczyk, A. Electromagnetic Field, Health and Environment: Proceedings of
`EHE'07. Amsterdam, IOS Press, 2008.
`SCHULTZBERG et al. Inflammation in the nervous system - Physiological and
`pathophysiological aspects. Physioloay & Behavior 92 (2007) 121-128.
`SELNES et al. Neurocognitive Complications after Coronary Artery Bypass Surgery.
`Ann Neural 2005;57:615-621.
`SHAFIK, A. Functional magnetic stimulation of the vagus nerve enhances colonic
`transit time in healthy volunteers. Tech Coloproctol (1999) 3:123-12.
`SIMILOWSKI, T. et al. Cervical magnetic stimulation: a new painless method for
`bilateral phrenic nerve stimulation in conscious humans. J. Appl. Physiol. 67(4): 1311-
`1318, 1989.
`SIMS et al. Assessing the clinical utility of the magnetic stimulator for measuring
`response latencies in the laryngeal muscles. Otolaryngol Head Neck Surg 1996;
`114:761-7.
`SJOGREN et al. Cognition-enhancing effect of vagus nerve stimulation in patients
`with Alzheimer's disease: a pilot study. J Clin Psychiatry. 2002 Nov;63(11) :972-80.
`SKOVRONSKY et al. Neurodegenerative Diseases: New Concepts of Pathogenesis
`and Their Therapeutic Implications. Annu. Rev. Pathol. Mech. Dis. 1(2006): 151-70.
`SMITH et al. The pathophysiology of multiple sclerosis: the mechanisms underlying
`the production of symptoms and the natural history of the disease. Philos Trans R
`Soc Lond B Biol Sci. 1999 October 29; 354(1390): 1649-1673.
`STUCHBURY G. et al. Alzheimer associated inflammation, potential drug targets and
`future therapies. J Neural Transm. 2005 Mar; 112(3) :429-53.
`SU IH KO. Modelling the response of scalp sensory receptors to transcranial electrical
`stimulation. Med. Biol. Eng. Comput., 2002, 40, 395-401
`TERRY, Jr. Vaaus nerve stimulation: a proven therapy for treatment of epilepsy
`
`74.
`
`75.
`
`76.
`
`77.
`
`78.
`
`79.
`
`80.
`81.
`82.
`
`83.
`
`84.
`
`85.
`
`86.
`
`87.
`
`88.
`
`89.
`
`90.
`
`91.
`
`92.
`
`93.
`
`Examiner
`/Jessica Sarcione/
`Si nature
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by CFR 1 .98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`US PTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case.
`Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`
`Date
`Considered 01/01/2013
`
`THISADDRA8EJ:Er-'{~EE!SSt:~J1~~11~Stl~W~t5Fs151~LbJED THROUGH. /J.S./
`
`LUMENIS EX1056
`Page 5
`
`

`

`ApprovedforusethroughO?JJ;~~\~lJ: 3766
`Receipt date: 10/17/2011
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid
`0MB control number.
`
`Complete if Known
`Aoolication Number
`13/005,005
`Filinq Date
`January 12, 2011
`Simon
`First Named Inventor
`Art Unit
`tbd
`Examiner Name
`tbd
`Attorney Docket Number
`ELEC-33
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`I 6
`I OF
`Sheet
`
`16
`
`94.
`
`95.
`
`96.
`
`97.
`98.
`
`99.
`
`100.
`
`101.
`
`102.
`103.
`
`104.
`
`105.
`
`strives to improve efficacy and expand applications. Cont Proc IEEE Eng Med Biol
`Soc. 2009;2009:4631-4
`The web site (www) of the National Institute of Neurological Disorders and Stroke
`(ninds) of the National Institutes of Health (nih) of the United States government (gov)
`in a subdirectory (!disorders/disorder index) web paae (htm).
`TOBINICK et al. Rapid cognitive improvement in Alzheimer disease following
`perispinal etanercept administration. Journal of Neuroinflammation 2008, 5:2.
`TRACEY. Physiology and immunology of the cholinergic antiinflammatory pathway. J.
`Clin. Invest. 117(2007): 289-296.
`TRACEY. The inflammatory reflex. Nature 420(2002): 853-859.
`TRACEY. Understanding immunity requires more than immunology. Nature
`lmmunoloav 11(2010): 561-564.
`TWEEDIE D. et al. TNF-alpha Inhibition as a Treatment Strategy for
`Neurodegenerative Disorders: New Drug Candidates and Targets. Curr Alzheimer
`Res 2007, 4(4):375-8.
`WAN et al. Postoperative impairment of cognitive function in rats: a possible role for
`cytokine-mediated inflammation in the hippocampus. Anesthesiology 2007; 106:436-
`43.
`WANG et al. A three-dimensional finite element method for computing magnetically
`induced currents in tissues. IEEE Transactions on Magnetics. 30 (6, Nov. 1994):
`5015-5023.
`www.ninds.nih.aov/disorders/disorder index.htm
`XIE GL et al. Relationship between perioperative inflammatory response and
`postoperative cognitive dysfunction in the elderly. Med Hypotheses 2009;73:402-3.
`XIONG J et al. Transcutaneous vagus nerve stimulation may attenuate postoperative
`coanitive dysfunction in elderly patients. Medical Hypotheses 73 (2009) 938-941.
`ZIPP et al. The brain as a target of inflammation: common pathways link inflammatory
`and neurodegenerative diseases. Trends in Neurosciences 29 (9, 2006) 518-527.
`
`Examiner
`/Jessica Sarcione/
`Date
`Si nature
`Considered
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by CFR 1 .98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`US PTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case.
`Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`
`01/01/2013
`
`THISADDRA8EJ:Er-'{~EE!SSt:~J1~~11~Stl~W~t5Fs151~LbJED THROUGH. /J.S./
`
`LUMENIS EX1056
`Page 6
`
`

`

`PTO/Sb/08b (06-09)
`Approved for use through 07/31/2009. 0MB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid
`0MB control number.
`
`Complete if Known
`Aoolication Number
`13/005,005
`January 12, 2011
`Filinq Date
`Simon
`First Named Inventor
`Art Unit
`tbd
`Examiner Name
`tbd
`Attorney Docket Number
`ELEC-33
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`I 1
`I OF
`Sheet
`16
`
`Exa
`mine
`r lnts
`
`Cite
`No.
`
`1 .
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`11 .
`
`12.
`
`13.
`
`14.
`
`15.
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when
`appropriate), title of the item (book, magazine, journal, serial, symposium,
`catalog, etc.), date, pages, volume/issue number(s), publisher, city and/or
`country where published.
`ALBERT, et al. Deep brain stimulation, vagal nerve stimulation and transcranial
`stimulation: An overview of stimulation parameters and neurotransmitter release.
`Neuroscience and Biobehavioral Reviews 33 (2009) 1042-1060.
`AL-MUTAWALY, et al. The Effects of Pulse Configuration on Magnetic Stimulation.
`Journal of Clinical Neurophysioloay 20(5):361-370, 2003.
`AMOR, et al. Inflammation in neurodegenerative diseases. Immunology, 129 (2010),
`154-169.
`ANDERSON, et al. Decreasing Procedural Pain Over Time of Left Prefrontal rTMS
`forDepression: Initial Results from the Open-Label Phase of a Multisite Trial (OPT-
`TMS). Brain Stimul. 2009 April 1; 2(2): 88-92.
`AZIZ et al. Magnetic Stimulation of Efferent Neural Pathways to the Human
`OesophaQus. Gut 33: S53-S70 (Poster Session F218) (1992).
`AZIZ, Q. et al. Esophageal myoelectric responses to magnetic stimulation of the
`human cortex and the extracranial vagus nerve. Am. J. Physiol. 267 (Gastrointest.
`Liver Physiol. 30): G827-G835, 1994.
`BASHAM, et al. Magnetic Stimulation of Neural Tissue: Techniques and System
`Design. pp 293- 352, In: Implantable Neural Prostheses 1, Devices and Applications,
`D. Zhou and E. Greenbaum, eds., New York: SprinQer (2009).
`BORCKARDT, et al. Reducing Pain and Unpleasantness During Repetitive
`Transcranial Maanetic Stimulation. Journal of ECT 2006; 22:259-264.
`BOWTELL et al. Analytic Calculations of the E-Fields Induced by Time-Varying
`Magnetic Fields Generated by Cylindrical Gradient Coils. Magnetic Resonance in
`Medicine 44:782-790 (2000).
`BREDESEN, et al. Cell death in the nervous system. Nature 443(2006): 796-802.
`CAMERON, MH, et al. Transcutaneous Electrical Nerve Stimulation (TENS) for
`dementia. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.:
`CD004032. (2009 update).
`CARBUNARU et al. Toroidal coil models for transcutaneous magnetic stimulation of
`nerves. IEEE Transactions on Biomedical Engineering. 48 (No. 4, April 2001 ): 434-
`441.
`FAIERSTEIN et al. Coil Designs for Localized and Efficient Magnetic Stimulation of
`the Nervous System. Ph.D. Dissertation, Department of Biomedical Engineering,
`Case Western Reserve, May, 1999. (UMI Microform Number: 9940153, UMI
`Company, Ann Arbor Ml).
`CHAE et al. A review of functional neuroimaging studies of vagus nerve stimulation
`(VNS). Journal of Psychiatric Research 37 (2003) 443-455.
`CHANG et al. Prevalence and risk factors for postoperative delirium in a
`cardiovascular intensive care unit. American Journal of Critical Care. 2008;17:567-
`
`I Examiner
`Signature
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and
`not considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`This collection of information is required by CFR 1 .98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`US PTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case.
`Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`LUMENIS EX1056
`Page 7
`
`

`

`PTO/Sb/08b (06-09)
`Ap

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket