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`_-001—US-20150073258 03-12-2015
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`MAZER; Aviv et al. —
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`Approved for use through 11/30/2020. OMB 0651-0031
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`STATEMENT BY APPL'CANT
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`Include name ofthe author(in CAPITAL LETTERS),titIe of the article(when appropriate), title of
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`N
`
`2016 Alzheimer's disease facts and figures. Alzheimers Dement 12(4):459-509 (2016).
`
`AUGUSTINACK et al. Entorhinal verrucae geometry is coincident and correlates with
`Alzheimer's lesions: a combined neuropathology and high-resolution ex vivo MRI analysis. Acta
`Neuropathol 123(1):85-96 (2012).
`
`BAKKER et al. Lymphatic Clearance of the Brain: Perivascular, Paravascular and Significance
`for Neurodegenerative Diseases. Cell Mol Neurobiol 36(2):181-194 (2016).
`
`BARNETT et al. Early intervention in Alzheimer's disease: a health economic study ofthe
`effects ofdiagnostic timing. BMC Neurology 14:101 (2014).
`
`CASH et al. The pattern of atrophy in familial Alzheimer disease: volumetric MRI results from
`the DIAN study. Neurology 81 (16):1425-1433 (2013).
`
`CAVEDO et al. The Road Ahead to Cure Alzheimer's Disease: Development of Biological
`Markers and Neuroimaging Methods for Prevention Trials Across all Stages and Target
`Populations. J Prev Alzheimers Dis 1(3):181-202 (2014).
`
`CHEN et al. Detecting microstructural properties of white matter based on compartmentalization
`of magnetic susceptibility. Neurolmage 70:1-9 (2013).
`
`FISCHER et al. Conversion from subtypes of mild cognitive impairment to Alzheimer dementia.
`Neurology 68(4):288—291 (2007).
`
`FRIEDMAN et al. US Prevalence And Predictors Of Informal Caregiving For Dementia. Health
`Aff (Millwood) 34(10):1637-1641 (2015).
`
`GAUTHIER et al. Mild cognitive impairment. Lancet 367(9518):1262-70 (2006).
`
`Examiner
`Signature
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`Considered
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`*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. 1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language
`Translation is attached. This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO 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, US. Patent and Trademark Office, PO. Box 1450, Alexandria, VA
`22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.0. 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.
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`Approved for use through 11/30/2020. OMB 0651-0031
`US. Patent and Trademark Office; US. 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 OMB control number.
`
`Substitute for form 1449/PTO
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`Complete if Known
`
`—15987794
`
`STATEMENT BY APPL'CANT
`(Use as many sheets as necessary)
`
`INFORMATION DISCLOSURE —Eifflj\ff;iRE PADIDEH
`Not ye} assigned
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`Attorney Docket Number
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`NON-PATENT LITERATURE DOCUMENTS
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`Examiner
`Initials*
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`'
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`Include name ofthe author(in CAPITAL LETTERS),titIe of the article(when appropriate), title of
`the item (book,magazine,journal,serial,symposium,cata|og,etc.),date,page(s),vo|ume-issue
`number(s),publisher, city and/or country where published.
`
`GREENE et al. Subregions of the inferior parietal lobule are affected in the progression to
`Alzheimer's disease. Neurobiol Aging 31(8):1304-1311 (2010).
`
`HAMPEL et al. Core candidate neurochemical and imaging biomarkers of Alzheimer's disease.
`Alzheimers Dement 2008. 4(1):38-48.
`
`HEBERT et al. Alzheimer disease in the United States (2010-2050) estimated using the 2010
`census. Neurology 80(19):1778-1783 (2013).
`
`HEBERT et al. Annual incidence of Alzheimer disease in the United States projected to the
`years 2000 through 2050. Alzheimer Dis Assoc Disord 15:169-173 (2001).
`
`HRABETOVA et al. Dead-space microdomains hinder extracellular diffusion in rat neocortex
`during ischemia. J Neurosci 23(23):8351-8359 (2003).
`
`HUANG et al. Longitudinal measurement and hierarchical classification framework forthe
`prediction of Alzheimer's disease. Sci Rep 7:39880 (2017).
`
`JENKINS et al. Developmental and age-related changes in rat brain glycosaminoglycans. J
`Neurochem 51 (5):1634-1640 (1988).
`
`KAMALl-ZARE et al. Brain extracellular space: geometry, matrix and physiological importance.
`Basic Clin Neurosci 4(4):282-286 (2013).
`
`KLOPPEL et al. Diagnostic neuroimaging across diseases. Neurolmage 61 :457-463 (2012).
`
`KRUGGEL et al. Analysis of longitudinal diffusion-weighted images in healthy and pathological
`aging: An ADNI study. J Neurosci Methods 278:101-115 (2017).
`
`LERCH et al. Studying neuroanatomy using MRI. Nat Neurosci 20(3):314-326 (2017).
`
`Examiner
`Signature
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`Date
`Considered
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`*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. 1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language
`Translation is attached. This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO 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
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`22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.0. 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.
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`

`

`Approved for use through 11/30/2020. OMB 0651-0031
`US. Patent and Trademark Office; US. 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 OMB control number.
`
`Substitute for form 1449/PTO
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`Complete if Known
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`—15987794
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`STATEMENT BY APPL'CANT
`(Use as many sheets as necessary)
`
`INFORMATION DISCLOSURE —Eifflj\ff;iRE PADIDEH
`Not ye} assigned
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`Attorney Docket Number
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`'
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`Include name ofthe author(in CAPITAL LETTERS),titIe of the article(when appropriate), title of
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`number(s),publisher, city and/or country where published.
`
`N
`
`LlEBMANN et al. Three-Dimensional Study of Alzheimer‘s Disease Hallmarks Using the iDlSCO
`Clearing Method. Cell Rep 16(4):1138-1152 (2016).
`
`MAYO et al. Longitudinal changes in microstructural white matter metrics in Alzheimer's
`disease. Neuroimage Clin 13:330-338 (2017).
`
`NICHOLSON et al. Brain Extracellular Space as a Diffusion Barrier. Comput Vis Sci 14(7):309-
`325 (2011).
`
`NICHOLSON et al. Diffusion of molecules in brain extracellular space: theory and experiment.
`Prog Brain Res 125:129-154 (2000).
`
`NICHOLSON et al. Extracellular space structure revealed by diffusion analysis. Trends
`Neurosci 21 (5):207-21 5 (1998).
`
`NICHOLSON et al. Hindered diffusion of high molecular weight compounds in brain extracellular
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`
`PAUS. Inferring causality in brain images: a perturbation approach. Phil Trans R. Soc. B.
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`
`PCT/USZO17/O64745 International Search Report and Written Opinion dated February 21,
`2018.
`
`PETERSEN et al. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol
`56(3):303-308 (1999).
`
`RUAN et al. Potential neuroimaging biomarkers of pathologic brain changes in Mild Cognitive
`Impairment and Alzheimer's disease: a systematic review. BMC Geriatr16:104 (2016).
`
`Examiner
`Signature
`
`Date
`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. 1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language
`Translation is attached. This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO 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, US. Patent and Trademark Office, PO. Box 1450, Alexandria, VA
`22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.0. 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.
`
`

`

`Approved for use through 11/30/2020. OMB 0651-0031
`US. Patent and Trademark Office; US. 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 OMB control number.
`
`Substitute for form 1449/PTO
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`Complete if Known
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`—15987794
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`STATEMENT BY APPL'CANT
`(Use as many sheets as necessary)
`
`INFORMATION DISCLOSURE —Eifflj\ff;iRE PADIDEH
`Not ye} assigned
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`Attorney Docket Number
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` N
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`
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`NON-PATENT LITERATURE DOCUMENTS
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`Examiner
`Initials*
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`'
`.
`
`Include name ofthe author(in CAPITAL LETTERS),titIe of the artic|e(when appropriate), title of
`the item (book,magazine,journal,seria|,symposium,cata|og,etc.),date,page(s),vo|ume-issue
`number(s),publisher, city and/or country where published.
`
`SCHMAND et al. Meta-analysis of CSF and MRI biomarkers for detecting preclinical
`Alzheimer's disease. Psychol Med 40(1):135-145 (2010).
`
`SYKOVA et al. Changes in extracellular space size and geometry in APP23 transgenic mice: a
`model of Alzheimer's disease. PNAS USA 102(2):479-484 (2005).
`
`SYKOVA et al. Diffusion in brain extracellular space. Physiol Rev 88(4):1277-1340 (2008).
`
`TAO et al. Maximum geometrical hindrance to diffusion in brain extracellular space surrounding
`uniformly spaced convex cells. J Theor Biol 229(1):59-68 (2004).
`
`THOMANN et al. The cerebellum in mild cognitive impairment and Alzheimer's disease - a
`structural MRI study. J Psychiatr Res 42(14):1198—1202 (2008).
`
`VISHNU. Implications of presymptomatic change in thalamus and caudate in Alzheimer's
`disease. Brain 136(Pt 11):e258 (2013).
`
`WEIMER et al. Early identification and treatment of Alzheimer's disease: social and fiscal
`outcomes. Alzheimers Dement 5:215-226 (2009).
`
`WEINER et al. 2014 Update of the Alzheimer's Disease Neuroimaging Initiative: A review of
`papers published since its inception. Alzheimers Dement 11(6):e1-120 (2015).
`
`XIE et al. Sleep drives metabolite clearance from the adult brain. Science 342(6156):373-377
`(2013).
`
`YOSHIYAMA et al. Synapse loss and microglial activation precede tangles in a P301S
`tauopathy mouse model. Neuron 53(3):337-351 (2007).
`
`Examiner
`Signature
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`Date
`Considered
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`*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. 1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language
`Translation is attached. This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO 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, US. Patent and Trademark Office, PO. Box 1450, Alexandria, VA
`22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.0. 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.
`
`

`

`Approved for use through 11/30/2020. OMB 0651-0031
`US. Patent and Trademark Office; US. 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 OMB control number.
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`Substitute for form 1449/PTO
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`Complete if Known
`
`—15987794
`
`STATEMENT BY APPL'CANT
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`INFORMATION DISCLOSURE —Eifflj\ff;iRE PADIDEH
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`and osmosis with extracellular space geometry. Phys Rev E 94(3-1):032411 (2016).
`
`NON-PATENT LITERATURE DOCUMENTS
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`Examiner
`|nitia|s*
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`'
`.
`
`Include name ofthe author(in CAPITAL LETTERS),titIe of the artic|e(when appropriate), title of
`the item (book,magazine,journal,seria|,symposium,cata|og,etc.),date,page(s),vo|ume-issue
`number(s),publisher, city and/or country where published.
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`YOUSEFNEZHAD et al. Unified model of brain tissue microstructure dynamically binds diffusion
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`*EXAMINER: lnitial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not considered. lnclude
`copy of this form with next communication to applicant. 1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language
`Translation is attached. This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO 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,
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`22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800—PTO-9199 (1 -800-786-91 99} and select option 2.
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`