IP Library › Granted Patent US 12,201,303
Granted Patent B2
US 12,201,303 · App. 18/458,099 · Granted Jan 21, 2025

Systems and methods for treating aneurysms

Inventors: Osama O. Zaidat (Lambertville, MI); Tiffany Tran Ngo (San Jose, CA); Razmik Soltanian (San Jose, CA); Edgard Luiz Ramos Pereira (Boca Raton, FL); Arturo Rosqueta (San Jose, CA); Thomas J. Wolfe (Shorewood, WI); Aamir Badruddin (Bolingbrook, IL)
Assignee: Galaxy Therapeutics, Inc.
A61B17/12172A61B17/12113A61B17/12177A61B2017/1205
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,201,303
App. No.
18/458,099
Granted
Jan 21, 2025
Kind
B2
Abstract

An apparatus for treating an aneurysm in a blood vessel includes an occlusion element configured to be releasably coupled to an elongate delivery shaft and configured to be delivered in a collapsed configuration through an inner lumen of a delivery catheter, the occlusion element including an inverted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an inversion fold, wherein at least the outer layer is formed into a first expanded shape including: a smooth outer cylinder configured to engage a wall of an aneurysm throughout a 360° circumference; and a substantially distal-facing surface including one or more heat-formed undulations, the one or more undulations configured to apply a radial force on the wall of the aneurysm.

Claims (38)

1. An apparatus for treating an aneurysm in a blood vessel, comprising:

an occlusion element configured to be releasably coupled to an elongate delivery shaft and configured to be delivered in a collapsed configuration through an inner lumen of a delivery catheter, the occlusion element comprising an inverted mesh tube having a first terminal end, a second terminal end, an outer layer, and an inner layer, the outer layer transitioning to the inner layer at an inversion fold, the first terminal end and the second terminal end located at a proximal end of the occlusion element, wherein at least the outer layer is formed into a first expanded shape comprising:

a smooth outer cylinder configured to engage a wall of the aneurysm throughout a 360° circumference; and

a substantially distal-facing surface comprising a plurality of heat-formed three-dimensional surface contours, the plurality of surface contours including at least a first contour comprising a convex peak and a second contour comprising a concave peak, the second contour adjacent to the first contour, wherein the first and second contours are together configured to apply a radial bias with the outer cylinder.

2. The apparatus of claim 1 , wherein the plurality of surface contours comprises a curvilinear contour that extends around an outer circumference substantially encircling the distal-facing surface.

3. The apparatus of claim 1 , wherein the plurality of surface contours extends along a diameter of the distal-facing surface.

4. The apparatus of claim 1 , wherein the plurality of surface contours extends along a radius of the distal-facing surface.

5. The apparatus of claim 1 , wherein the plurality of surface contours extends along a chord of the distal-facing surface.

6. The apparatus of claim 1 , wherein the plurality of surface contours extends along a partial radius of the distal-facing surface.

7. The apparatus of claim 1 , wherein the plurality of surface contours extends along a partial chord of the distal-facing surface.

8. The apparatus of claim 1 , wherein the plurality of surface contours includes a surface contour having a sinusoidal wave shape.

9. The apparatus of claim 1 , wherein the plurality of surface contours includes a surface contour comprising a wave shape having an increasing frequency along a wave axis.

10. The apparatus of claim 1 , wherein the plurality of surface contours includes a surface contour comprising a wave shape comprising a plurality of peaks having substantially equal peak heights.

11. The apparatus of claim 1 , wherein the plurality of surface contours includes a surface contour comprising a wave shape comprising a plurality of peaks having peak heights that decrease along a wave axis.

12. The apparatus of claim 1 , wherein the occlusion element further comprises:

a proximal concavity.

13. The apparatus of claim 1 , wherein the outer cylinder defines a frustoconical surface.

14. The apparatus of claim 13 , wherein the occlusion element has a maximum diameter at a portion of the frustoconical surface that is adjacent to the distal-facing surface.

15. The apparatus of claim 1 , wherein the occlusion element has a total height and a maximum diameter, and wherein a total height to maximum diameter ratio is between about 0.25 and about 0.57.

16. An apparatus for treating an aneurysm in a blood vessel, comprising:

an occlusion element configured to be releasably coupled to an elongate delivery shaft and configured to be delivered in a collapsed configuration through an inner lumen of a delivery catheter, the occlusion element comprising an inverted mesh tube having a first terminal end, a second terminal end, an outer layer, and an inner layer, the outer layer transitioning to the inner layer at an inversion fold, the first terminal end and the second terminal end located at a proximal end of the occlusion element, wherein at least the outer layer is formed into a first expanded shape comprising:

an outer lateral surface extending around the occlusion element; and

a substantially distal-facing surface comprising a plurality of heat-formed three-dimensional surface contours, the plurality of surface contours including at least a first contour comprising a convex peak and a second contour comprising a concave peak, the second contour adjacent to the first contour, wherein the first and second contours are together configured to apply a radial bias with the outer lateral surface.

17. The apparatus of claim 16 , wherein the plurality of surface contours comprises a curvilinear contour that extends around an outer circumference substantially encircling the distal-facing surface.

18. The apparatus of claim 16 , wherein the plurality of surface contours extends along a diameter of the distal-facing surface.

19. The apparatus of claim 16 , wherein the plurality of surface contours extends along a radius of the distal-facing surface.

20. The apparatus of claim 16 , wherein the plurality of surface contours extends along a chord of the distal-facing surface.

21. The apparatus of claim 16 , wherein the plurality of surface contours extends along a partial radius of the distal-facing surface.

22. The apparatus of claim 16 , wherein the plurality of surface contours extends along a partial chord of the distal-facing surface.

23. The apparatus of claim 16 , wherein the plurality of surface contours includes a surface contour having a sinusoidal wave shape.

24. The apparatus of claim 16 , wherein the plurality of surface contours includes a surface contour comprising a wave shape having an increasing frequency along a wave axis.

25. The apparatus of claim 16 , wherein the plurality of surface contours includes a surface contour comprising a wave shape comprising a plurality of peaks having substantially equal peak heights.

26. The apparatus of claim 16 , wherein the plurality of surface contours includes a surface contour comprising a wave shape comprising a plurality of peaks having peak heights that decrease along a wave axis.

27. The apparatus of claim 16 , wherein the occlusion element further comprises:

a proximal concavity.

28. The apparatus of claim 16 , wherein the outer lateral surface is a frustoconical surface.

29. The apparatus of claim 28 , wherein the occlusion element has a maximum diameter at a portion of the frustoconical surface that is adjacent to the distal-facing surface.

30. The apparatus of claim 16 , wherein the occlusion element has a total height and a maximum diameter, and wherein a total height to maximum diameter ratio is between about 0.25 and about 0.57.

Continuity (5)
Continuation 18353880 · Jul 17, 2023
Continuation PCTUS2022013986 · Jan 27, 2022
Provisional Application 63213030 · Jun 21, 2021
Provisional Application 63142480 · Jan 27, 2021
Related Publication 20230404591A1 · Dec 21, 2023
References Cited (223)
US 5250071A · Palermo · 1993 [cited by applicant]
US 5282806A · Haber et al. · 1994 [cited by applicant]
US 5304195A · Twyford, Jr. et al. · 1994 [cited by applicant]
US 5556390A · Hicks · 1996 [cited by applicant]
US 5795331A · Cragg et al. · 1998 [cited by applicant]
US 5935148A · Villar et al. · 1999 [cited by applicant]
US 6086577A · Ken et al. · 2000 [cited by applicant]
US 6093199A · Brown et al. · 2000 [cited by applicant]
US 6152144A · Lesh et al. · 2000 [cited by applicant]
US 6391037B1 · Greenhalgh · 2002 [cited by applicant]
US 6454780B1 · Wallace · 2002 [cited by applicant]
US 6506204B2 · Mazzochi · 2003 [cited by applicant]
US 6544163B2 · Wallace et al. · 2003 [cited by applicant]
US 6613074B1 · Mitelberg et al. · 2003 [cited by applicant]
US D493223S · Solymar · 2004 [cited by applicant]
US 6936055B1 · Ken et al. · 2005 [cited by applicant]
US 6994689B1 · Zadno-Azizi et al. · 2006 [cited by applicant]
US 7128736B1 · Abrams et al. · 2006 [cited by applicant]
US 7195636B2 · Avellanet et al. · 2007 [cited by applicant]
US 7229461B2 · Chin et al. · 2007 [cited by applicant]
US 7367985B2 · Mazzochi et al. · 2008 [cited by applicant]
US 7410482B2 · Murphy et al. · 2008 [cited by applicant]
US 7569066B2 · Gerberding et al. · 2009 [cited by applicant]
US 7749242B2 · Tran et al. · 2010 [cited by applicant]
US 8142456B2 · Rosqueta et al. · 2012 [cited by applicant]
US 8333796B2 · Tompkins et al. · 2012 [cited by applicant]
US 8388650B2 · Gerberding et al. · 2013 [cited by applicant]
US 8398670B2 · Amplatz et al. · 2013 [cited by applicant]
US 8551132B2 · Eskridge et al. · 2013 [cited by applicant]
US 8597320B2 · Sepetka et al. · 2013 [cited by applicant]
US 8728117B1 · Janardhan et al. · 2014 [cited by applicant]
US 8777979B2 · Shrivastava et al. · 2014 [cited by applicant]
US D713527S · Heipl · 2014 [cited by applicant]
US 8820207B2 · Marchand et al. · 2014 [cited by applicant]
US 8826791B2 · Thompson et al. · 2014 [cited by applicant]
US 8864790B2 · Strauss et al. · 2014 [cited by applicant]
US 8864791B2 · Bloom et al. · 2014 [cited by applicant]
US 8940015B2 · Kariniemi · 2015 [cited by applicant]
US D727500S · Heipl · 2015 [cited by applicant]
US D727501S · Heipl · 2015 [cited by applicant]
US D728102S · Heipl · 2015 [cited by applicant]
US 8998947B2 · Aboytes et al. · 2015 [cited by applicant]
US 9107670B2 · Hannes et al. · 2015 [cited by applicant]
US 9113890B2 · Dasnukar et al. · 2015 [cited by applicant]
US 9179899B2 · Freudenthal · 2015 [cited by applicant]
US 9198668B2 · Theobald et al. · 2015 [cited by applicant]
US 9259337B2 · Cox et al. · 2016 [cited by applicant]
US 9314326B2 · Wallace et al. · 2016 [cited by applicant]
US 9510811B2 · Akpinar · 2016 [cited by applicant]
US 9585670B2 · Hines · 2017 [cited by applicant]
US 9597087B2 · Marchand et al. · 2017 [cited by applicant]
US 9636117B2 · Bachman et al. · 2017 [cited by applicant]
US 9669188B2 · Echarri et al. · 2017 [cited by applicant]
US 9855052B2 · Aboytes et al. · 2018 [cited by applicant]
US 9877726B2 · Liu et al. · 2018 [cited by applicant]
US 9918720B2 · Marchand et al. · 2018 [cited by applicant]
US 9980733B2 · Badruddin et al. · 2018 [cited by applicant]
US 10111670B2 · Lorenzo et al. · 2018 [cited by applicant]
US 10123805B2 · Ayres et al. · 2018 [cited by applicant]
US 10136896B2 · Hewitt et al. · 2018 [cited by applicant]
US 10149676B2 · Mirigian et al. · 2018 [cited by applicant]
US 10478195B2 · Aboytes et al. · 2019 [cited by applicant]
US 10751065B2 · Soto Del Valle et al. · 2020 [cited by applicant]
US 10792045B2 · Wang et al. · 2020 [cited by applicant]
US 10856880B1 · Badruddin et al. · 2020 [cited by applicant]
US 11026694B2 · Wang et al. · 2021 [cited by applicant]
US 11058431B2 · Pereira et al. · 2021 [cited by applicant]
US 11166731B2 · Wolfe et al. · 2021 [cited by applicant]
US 11202636B2 · Zaidat et al. · 2021 [cited by applicant]
US 11278292B2 · Gorochow et al. · 2022 [cited by applicant]
US 11413046B2 · Xu et al. · 2022 [cited by applicant]
US 11497504B2 · Xu et al. · 2022 [cited by applicant]
US 11559309B2 · Rangwala et al. · 2023 [cited by applicant]
US 11583282B2 · Gorochow et al. · 2023 [cited by applicant]
US 11596412B2 · Xu et al. · 2023 [cited by applicant]
US 11602350B2 · Gorochow et al. · 2023 [cited by applicant]
US 20020169473A1 · Sepetka et al. · 2002 [cited by applicant]
US 20020188314A1 · Anderson et al. · 2002 [cited by applicant]
US 20030171770A1 · Kusleika et al. · 2003 [cited by applicant]
US 20030176884A1 · Berrada et al. · 2003 [cited by applicant]
US 20030195553A1 · Wallace et al. · 2003 [cited by applicant]
US 20040034386A1 · Fulton et al. · 2004 [cited by applicant]
US 20040044391A1 · Porter · 2004 [cited by applicant]
US 20040172056A1 · Guterman et al. · 2004 [cited by applicant]
US 20040199201A1 · Kellett et al. · 2004 [cited by applicant]
US 20050033409A1 · Burke et al. · 2005 [cited by applicant]
US 20050107823A1 · Leone et al. · 2005 [cited by applicant]
US 20050171478A1 · Selmon et al. · 2005 [cited by applicant]
US 20050277978A1 · Greenhalgh · 2005 [cited by applicant]
US 20060064151A1 · Guterman et al. · 2006 [cited by applicant]
US 20060106417A1 · Tessmer et al. · 2006 [cited by applicant]
US 20060155323A1 · Porter et al. · 2006 [cited by applicant]
US 20070173928A1 · Morsi · 2007 [cited by applicant]
US 20070208376A1 · Meng · 2007 [cited by applicant]
US 20070225794A1 · Thramann et al. · 2007 [cited by applicant]
US 20070270902A1 · Slazas et al. · 2007 [cited by applicant]
US 20080045997A1 · Balgobin et al. · 2008 [cited by applicant]
US 20080097495A1 · Feller, III et al. · 2008 [cited by applicant]
US 20080147100A1 · Wallace · 2008 [cited by applicant]
US 20080281350A1 · Sepetka et al. · 2008 [cited by applicant]
US 20080319533A1 · Lehe · 2008 [cited by applicant]
US 20090062841A1 · Amplatz et al. · 2009 [cited by applicant]
US 20090082803A1 · Adams et al. · 2009 [cited by applicant]
US 20090099647A1 · Glimsdale et al. · 2009 [cited by applicant]
US 20090177261A1 · Teoh et al. · 2009 [cited by applicant]
US 20090264978A1 · Dieck et al. · 2009 [cited by applicant]
US 20090287291A1 · Becking et al. · 2009 [cited by applicant]
US 20090318941A1 · Sepetka et al. · 2009 [cited by applicant]
US 20100179583A1 · Carpenter et al. · 2010 [cited by applicant]
US 20110046719A1 · Frid · 2011 [cited by applicant]
US 20110144669A1 · Becking et al. · 2011 [cited by applicant]
US 20110152993A1 · Marchand et al. · 2011 [cited by applicant]
US 20110202085A1 · Loganathan et al. · 2011 [cited by applicant]
US 20120065667A1 · Javois et al. · 2012 [cited by applicant]
US 20120071911A1 · Sadasivan et al. · 2012 [cited by applicant]
US 20120143317A1 · Cam et al. · 2012 [cited by applicant]
US 20120245675A1 · Molaei et al. · 2012 [cited by applicant]
US 20120259244A1 · Roberts et al. · 2012 [cited by applicant]
US 20120283768A1 · Cox et al. · 2012 [cited by applicant]
US 20120303052A1 · Connor · 2012 [cited by applicant]
US 20120310270A1 · Murphy et al. · 2012 [cited by applicant]
US 20120330347A1 · Becking et al. · 2012 [cited by applicant]
US 20130066357A1 · Abotes et al. · 2013 [cited by applicant]
US 20130073026A1 · Russo et al. · 2013 [cited by applicant]
US 20130190800A1 · Murphy et al. · 2013 [cited by applicant]
US 20130211495A1 · Halden et al. · 2013 [cited by applicant]
US 20140005714A1 · Quick et al. · 2014 [cited by applicant]
US 20140012303A1 · Heipl · 2014 [cited by applicant]
US 20140052233A1 · Cox et al. · 2014 [cited by applicant]
US 20140172001A1 · Becking et al. · 2014 [cited by applicant]
US 20140257360A1 · Keillor · 2014 [cited by applicant]
US 20140277013A1 · Sepetka et al. · 2014 [cited by applicant]
US 20140343602A1 · Cox et al. · 2014 [cited by applicant]
US 20150005811A1 · Lubock et al. · 2015 [cited by applicant]
US 20150133989A1 · Lubock et al. · 2015 [cited by applicant]
US 20150250628A1 · Monstadt et al. · 2015 [cited by applicant]
US 20150272589A1 · Lorenzo · 2015 [cited by applicant]
US 20150313605A1 · Griffin · 2015 [cited by applicant]
US 20160022445A1 · Ruvalcava et al. · 2016 [cited by applicant]
US 20160030050A1 · Franano et al. · 2016 [cited by applicant]
US 20160151056A1 · Lederman · 2016 [cited by examiner]
US 20160278749A1 · Javois et al. · 2016 [cited by applicant]
US 20160317277A1 · Carpenter et al. · 2016 [cited by applicant]
US 20170014114A1 · Radfiee et al. · 2017 [cited by applicant]
US 20170156734A1 · Griffin · 2017 [cited by applicant]
US 20170224350A1 · Shimizu et al. · 2017 [cited by applicant]
US 20170224355A1 · Bowman et al. · 2017 [cited by applicant]
US 20170333046A1 · Roselli · 2017 [cited by applicant]
US 20170348014A1 · Wallace et al. · 2017 [cited by applicant]
US 20170367708A1 · Mayer et al. · 2017 [cited by applicant]
US 20170367713A1 · Greene, Jr. et al. · 2017 [cited by applicant]
US 20180049731A1 · Hardy et al. · 2018 [cited by applicant]
US 20180242979A1 · Lorenzo · 2018 [cited by applicant]
US 20190053810A1 · Griffin · 2019 [cited by applicant]
US 20190110796A1 · Jayaraman · 2019 [cited by applicant]
US 20190192165A1 · Greene, Jr. et al. · 2019 [cited by applicant]
US 20190192167A1 · Lorenzo · 2019 [cited by applicant]
US 20190192168A1 · Lorenzo · 2019 [cited by applicant]
US 20190223876A1 · Badruddin et al. · 2019 [cited by applicant]
US 20190223878A1 · Lorenzo et al. · 2019 [cited by applicant]
US 20190223881A1 · Hewitt et al. · 2019 [cited by applicant]
US 20190357914A1 · Gorochow et al. · 2019 [cited by applicant]
US 20200113576A1 · Gorochow et al. · 2020 [cited by applicant]
US 20200367900A1 · Pedroso · 2020 [cited by examiner]
US 20200367906A1 · Xu et al. · 2020 [cited by applicant]
US 20210128160A1 · Li et al. · 2021 [cited by applicant]
US 20210128161A1 · Nageswaran et al. · 2021 [cited by applicant]
US 20210128162A1 · Rhee et al. · 2021 [cited by applicant]
US 20210128165A1 · Pulugurtha et al. · 2021 [cited by applicant]
US 20210128167A1 · Patel et al. · 2021 [cited by applicant]
US 20210128168A1 · Nguyen et al. · 2021 [cited by applicant]
US 20210128169A1 · Li et al. · 2021 [cited by applicant]
US 20210129275A1 · Nguyen et al. · 2021 [cited by applicant]
US 20210153872A1 · Nguyen et al. · 2021 [cited by applicant]
US 20210169499A1 · Merritt et al. · 2021 [cited by applicant]
US 20210275184A1 · Hewitt et al. · 2021 [cited by applicant]
US 20210282789A1 · Vu et al. · 2021 [cited by applicant]
US 20210338247A1 · Gorochow · 2021 [cited by applicant]
US 20210346032A1 · Patterson et al. · 2021 [cited by applicant]
US 20220110710A1 · Rangwala et al. · 2022 [cited by applicant]
US 20220125567A1 · Center et al. · 2022 [cited by applicant]
US 20220192678A1 · Hewitt et al. · 2022 [cited by applicant]
US 20220202401A1 · Isilki · 2022 [cited by examiner]
US 20220202425A1 · Gorochow et al. · 2022 [cited by applicant]
US 20220249098A1 · Milhous et al. · 2022 [cited by applicant]
US 20220257258A1 · Hewitt et al. · 2022 [cited by applicant]
US 20220257260A1 · Hewitt et al. · 2022 [cited by applicant]
US 20220304696A2 · Rhee et al. · 2022 [cited by applicant]
US 20220304699A1 · Gorochow · 2022 [cited by applicant]
US 20220378435A1 · Dholakia et al. · 2022 [cited by applicant]
US 20230017191A1 · Gorochow et al. · 2023 [cited by applicant]
CN 102871700B · 2015 [cited by applicant]
CN 103006285B · 2015 [cited by applicant]
DE 102012016555A1 · 2014 [cited by applicant]
DE 102013006503A1 · 2014 [cited by applicant]
EP 0832607A1 · 1998 [cited by applicant]
EP 3146916A1 · 2017 [cited by applicant]
EP 2647343B1 · 2017 [cited by applicant]
WO WO199905977A1 · 1999 [cited by applicant]
WO WO200200139A1 · 2002 [cited by applicant]
WO WO2005107650A2 · 2005 [cited by applicant]
WO WO2008156464A1 · 2008 [cited by applicant]
WO WO2009055782A1 · 2009 [cited by applicant]
WO WO2009132045A2 · 2009 [cited by applicant]
WO WO2012009675A2 · 2012 [cited by applicant]
WO WO2013138615A2 · 2013 [cited by applicant]
WO WO2015057796A1 · 2015 [cited by applicant]
WO WO2015168249A1 · 2015 [cited by applicant]
WO WO2017102804A1 · 2017 [cited by applicant]
WO WO2017153603A1 · 2017 [cited by applicant]
WO WO2017220400A1 · 2017 [cited by applicant]
WO WO2019038293A1 · 2019 [cited by applicant]
WO WO2020243039A1 · 2020 [cited by applicant]
Shapiro, M., Raz, E., Becske, T., Nelson, P., “Variable Porosity of the Pipeline Embolization Device in Straight and Curved Vessels: A Guide for Optimal Deployment Strategy”, Original Research Interventional, Sep. 26, 2… [cited by applicant]
Perez, M., Henkes, H., Bouillot, P., Brina, O., Slater, L., Pereira, V., “Intra-aneurysmal hemodynamics: evaluation of pCONus and pCANvas bifurcation aneurysm devices using DSA optical flow imaging”, Journal of NeuroInt… [cited by applicant]
Torii, R., Oshima, M., Kobayashi, T., Takagi, K., Tezduyar, T., “Fluid-structure interaction modeling of a patient-specific cerebral aneurysm: influence of structural modeling.” Computational Mechanics 43: 151-159 (2008… [cited by applicant]
Control, etc. http://www.asianjns.org/articles/2012/7/4/images/AsianJNeurosurg_2012_7_4_159_106643_f7.jpg downloaded from internet Apr. 3, 2020. [cited by applicant]
Cerus https://neuronewsinternational-wpengine.netdna-ssl.com/wp-content/uploads/sites/3/2016/07/Cerus-Endovascular-Contour-300×194.jpg downloaded from internet Apr. 3, 2020. [cited by applicant]
Contour https://neuronewsinternational-wpengine.netdna-ssl.com/wp-content/uploads/sites/3/2017/06/Contour-e1497957260381-300×194.png downloaded from internet Apr. 3, 2020. [cited by applicant]
Medtronic https://evtoday.com/images/articles/2017-02/0217-endovascular-fig1.png downloaded from internet Apr. 3, 2020. [cited by applicant]
Bhogal, P., Udani, S., Cognard, C., Piotin, M., Brouwer, P., Sourour, N., Andersson, T., Makalanda, L., Wong, K., Fiorella, D., Arthur, A., Yeo, L., Soderman, M., Henkes, H., Pierot, L., “Endovascular flow disruption: w… [cited by applicant]
PCT International Search Report and Written Opinion for PCT/US2022/013986, Galaxy Therapeutics, Inc., Forms PCT/ISA/220, 210, and 237 dated Jun. 2, 2022 (14 pages). [cited by applicant]
Extended European Search Report dated May 27, 2024, in EP App. No. 22746262.2 filed Jan. 27, 2022 (9 pages). [cited by applicant]