IP Library › Granted Patent US 12,576,037
Granted Patent B2
US 12,576,037 · App. 17/180,338 · Granted Mar 17, 2026

Polymer-encapsulated drug particles

Inventors: Lixiao Wang (Henderson, NV); Peter Barnett (Shakopee, MN)
Assignee: Tonic Medical, Inc.
A61K9/4816A61K9/4833A61K31/337A61K31/436A61M25/10A61M25/1029A61P1/00A61M2025/1031A61M2025/105A61M2210/105
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Quick Facts
Patent No.
US 12,576,037
App. No.
17/180,338
Granted
Mar 17, 2026
Kind
B2
Abstract

Various embodiments disclosed relate to polymer-encapsulated drug particles and a drug-releasing coating including the same, as well as drug-coated balloon catheters for treating, preventing, or reducing the recurrence of strictures in body lumens and methods of using the same. A drug-coated balloon catheter for delivering a therapeutic agent to a target site of a body lumen stricture includes an elongated balloon. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. The coating layer includes the polymer-encapsulated drug particles; or a drug-releasing coating including the polymer-encapsulated drug particles; or a therapeutic agent and a first and/or second additive; or a combination thereof.

Claims (77)

1 . Polymer-encapsulated drug particles comprising:

a therapeutic agent;

one or more polymers that encapsulate the therapeutic agent; and

a first ionic or zwitterionic additive in the polymer-encapsulated drug particles;

wherein

the one or more polymers are less than or equal to 80 wt % of the polymer-encapsulated drug particles,

the first ionic or zwitterionic additive is 0.5 wt % to 20 wt % of the polymer-encapsulated drug particles, and a total amount of lipids in the polymer-encapsulated drug particles is 0.5 wt % to 20 wt % of the polymer-encapsulated drug particles,

the polymer-encapsulated drug particles have a weight ratio of the first ionic or zwitterionic additive to the one or more polymers of 1:3 to 1:60, and a weight ratio of the total amount of lipids in the polymer-encapsulated drug particles to the one or more polymers of 1:3 to 1:60,

the first ionic or zwitterionic additive comprises a mismatched charged lipid and/or phospholipid, 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-diheptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-didecanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof,

two acyl groups of the mismatched charged lipid or phospholipid comprise mis-matched acyl groups, wherein the mis-matched acyl groups differ by length, degree of saturation, substituents thereon, substitution patterns thereon, or a combination thereof, and

wherein the polymer-encapsulated drug particles are on a balloon of a balloon catheter such that a concentration density of the therapeutic agent on the balloon catheter is 1 μg/mm 2 to 20 μg/mm 2 as measured with the balloon at nominal diameter.

2 . The polymer-encapsulated drug particles of claim 1 , wherein the first ionic or zwitterionic additive further comprises polylysine and/or a cationic or anionic molecule.

3 . The polymer-encapsulated drug particles of claim 1 , wherein the therapeutic agent is amorphous, partially amorphous, or a combination thereof.

4 . The polymer-encapsulated drug particles of claim 1 , wherein the therapeutic agent is crystalline or partially crystalline.

5 . The polymer-encapsulated drug particles of claim 1 , wherein the polymer is at least one polymer chosen from polylactic acid (PLA), polyglycolic acid (PGA), a polylactic acid/polyglycolic acid copolymer (PLGA), polydioxanone, polycaprolactone, polyphosphazene, collagen, gelatin, chitosan, glycosoaminoglycans, and copolymers thereof.

6 . The polymer-encapsulated drug particles of claim 1 , wherein the first ionic or zwitterionic additive comprises 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-dibeptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-decanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof.

7 . The polymer-encapsulated drug particles of claim 1 , wherein the mis-matched acyl groups have lengths of C6-C34.

8 . The polymer-encapsulated drug particles of claim 1 , wherein the mis-matched acyl groups differ by length.

9 . The polymer-encapsulated drug particles of claim 1 , wherein the first ionic or zwitterionic additive is chosen from 1-palmitoyl-2-stearoyl-sn-glycero-3-phosphocholine, 1-stearoyl-2-palmitoyl-sn-glycero-3-phosphocholine, 1-palmitoyl-2-lauroyl-sn-glycero-3-phosphocholine, 1-palmitoyl-2-oleoyl-glycero-3-phosphocholine (POPC), 1-stearoyl-2-hydroxy-sn-glycero-3-phosphocholine, 1-lauroyl-2-hydroxy-sn-glycero-3-phosphocholine, 1-myristoyl-2-hydroxy-sn-glycero-3-phosphocholine, 1-palmitoyl-2-hydroxy-sn-glycero-3-phosphocholine, and a combination thereof.

10 . The polymer-encapsulated drug particles of claim 1 , wherein the therapeutic agent is chosen from paclitaxel, docetaxel, taxol, an mTOR inhibitor, rapamycin, sirolimus, zotarolimus, everolimus, tacrolimus, umirolimus, daunorubicin, doxorubicin, an analogue thereof, and a combination thereof.

11 . The polymer-encapsulated drug particles of claim 1 , wherein the polymer-encapsulated drug particles have a diameter of 1 micron to 5 microns.

12 . The polymer-encapsulated drug particles of claim 1 , wherein:

the one or more polymers are less than or equal to 80 wt % of the polymer-encapsulated drug particles,

the first ionic or zwitterionic additive is 2 wt % to 10 wt % of the polymer-encapsulated drug particles, and the total amount of lipids in the polymer-encapsulated drug particles is 2 wt % to 10 wt % of the polymer-encapsulated drug particles, and

the polymer-encapsulated drug particles have a weight ratio of the first ionic or zwitterionic additive to the one or more polymers of 1:3 to 1:30, and a weight ratio of the total amount of lipids in the polymer-encapsulated drug particles to the one or more polymers is 1:3 to 1:30.

13 . The polymer-encapsulated drug particles of claim 1 , wherein the one or more polymers comprise PLGA having a weight ratio of lactic acid to glycolic acid of about 85:15 and/or PLGA having a weight ratio of lactic acid to glycolic acid of about 75:25.

14 . The polymer-encapsulated drug particles of claim 1 , wherein the therapeutic agent is sirolimus.

15 . The polymer-encapsulated drug particles of claim 1 , wherein the polymer-encapsulated drug particles comprise a largest dimension of equal to or greater than 0.2 microns and less than or equal to 30 microns, as determined using laser light refraction.

16 . A drug-releasing coating comprising:

the polymer-encapsulated drug particles of claim 1 ; and

a release matrix comprising a second ionic or zwitterionic additive, wherein the second ionic or zwitterionic additive comprises a cationic molecule, an anionic molecule, a mismatched charged lipid and/or phospholipid, 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-diheptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-didecanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof, wherein two acyl groups of the mismatched charged lipid or phospholipid comprise mis-matched acyl groups, and wherein the mis-matched acyl groups differ by length, degree of saturation, substituents thereon, substitution patterns thereon, or combinations thereof.

17 . The drug-releasing coating of claim 16 , wherein the polymer-encapsulated drug particles are 10 wt % to 80 wt % of the drug-releasing coating by dry measure.

18 . The drug-releasing coating of claim 17 , wherein the second ionic or zwitterionic additive is chosen from 1-palmitoyl-2-stearoyl-sn-glycero-3-phosphocholine, 1-stearoyl-2-palmitoyl-sn-glycero-3-phosphocholine, 1-palmitoyl-2-lauroyl-sn-glycero-3-phosphocholine, 1-palmitoyl-2-oleoyl-glycero-3-phosphocholine (POPC), 1-stearoyl-2-hydroxy-sn-glycero-3-phosphocholine, 1-lauroyl-2-hydroxy-sn-glycero-3-phosphocholine, 1-myristoyl-2-hydroxy-sn-glycero-3-phosphocholine, 1-palmitoyl-2-hydroxy-sn-glycero-3-phosphocholine, and a combination thereof.

19 . The drug-releasing coating of claim 16 , wherein the second ionic or zwitterionic additive has a different molecular structure from the first ionic or zwitterionic additive.

20 . The drug-releasing coating of claim 16 , wherein the second ionic or zwitterionic additive in the release matrix comprises 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-diheptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-decanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof.

21 . The drug-releasing coating of claim 16 , further comprising pentaerythritol ethoxylate.

22 . The drug-releasing coating of claim 16 , wherein the release matrix comprises particles of a second therapeutic agent that are free of encapsulation by the polymer, the second therapeutic agent is chosen from paclitaxel, docetaxel, taxol, an mTOR inhibitor, rapamycin, sirolimus, zotarolimus, everolimus, tacrolimus, umirolimus, daunorubicin, doxorubicin, an analogue thereof, and a combination thereof.

23 . The drug-releasing coating of claim 16 , wherein the release matrix comprises poly-L-lysine, polylysine, polyvinyl alcohol (PVA), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof.

24 . A balloon catheter comprising:

an elongated balloon; and

a coating layer overlying an exterior surface of the balloon, the coating layer comprising the drug-releasing coating of claim 16 .

25 . Polymer-encapsulated drug particles comprising:

a therapeutic agent;

one or more polymers that encapsulate the therapeutic agent; and

a first ionic or zwitterionic additive in the polymer-encapsulated drug particles;

wherein

the one or more polymers are less than or equal to 80 wt % of the polymer-encapsulated drug particles,

the first ionic or zwitterionic additive is less than or equal to 20 wt % of the polymer-encapsulated drug particles, and a total amount of lipids in the polymer-encapsulated drug particles is less than or equal to 20 wt % of the polymer-encapsulated drug particles,

the polymer-encapsulated drug particles have a weight ratio of the first ionic or zwitterionic additive to the one or more polymers of 1:3 to 1:60, and a weight ratio of the total amount of lipids in the polymer-encapsulated drug particles to the one or more polymers of 1:3 to 1:60,

the first ionic or zwitterionic additive comprises a mismatched charged lipid and/or phospholipid, 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-diheptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-didecanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof,

two acyl groups of the mismatched charged lipid or phospholipid comprise mis-matched acyl groups, wherein the mis-matched acyl groups differ by length, degree of saturation, substituents thereon, substitution patterns thereon, or a combination thereof, and

wherein the polymer-encapsulated drug particles are on a balloon of a balloon catheter such that a concentration density of the therapeutic agent on the balloon catheter is 1 μg/mm 2 to 20 μg/mm 2 as measured with the balloon at nominal diameter.

26 . A drug-releasing coating comprising:

the polymer-encapsulated drug particles of claim 25 ; and

a release matrix comprising a second ionic or zwitterionic additive, wherein the second ionic or zwitterionic additive comprises a cationic molecule, an anionic molecule, a mismatched charged lipid and/or phospholipid, 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-diheptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-didecanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof, wherein two acyl groups of the mismatched charged lipid or phospholipid comprise mis-matched acyl groups, and wherein the mis-matched acyl groups differ by length, degree of saturation, substituents thereon, substitution patterns thereon, or combinations thereof.

27 . A method for treating or preventing a nonvascular or vascular stricture or stenosis, the method comprising:

inserting the balloon catheter comprising the polymer-encapsulated drug particles of claim 1 into the body lumen;

expanding the balloon or stent to contact the coating layer with the stricture, stenosis, or area wherein the stricture or stenosis is to be prevented;

when a balloon is used, the method further comprises deflating the balloon; and

when a balloon is used, the method further comprises removing the balloon from the body lumen.

28 . A method for treatment or prevention of a stenosed heart valve, the method comprising:

inserting the balloon catheter comprising the polymer-encapsulated drug articles of claim 1 into a target site in the heart valve;

inflating the balloon at the target site to contact the coating layer of the balloon with the inner luninal wall and dilate the heart valve stenosis until the balloon achieves an inflated balloon diameter for an inflation period;

deflating the balloon after the inflation period; and

withdrawing the balloon catheter from the body lumen.

29 . A method of making a balloon catheter, the method comprising:

applying the drug-releasing coating of claim 16 to an exterior of a balloon of a balloon catheter.

30 . A method for prevention or treatment of strictures in the digestive body lumen or the gastrointestinal tract, the method comprising:

inserting the balloon catheter of claim 24 into a target site in a body lumen comprising the non-vascular stricture;

inflating the balloon at the target site to contact the coating layer with walls of the body lumen at the location of the non-vascular stricture until the balloon achieves an inflated balloon diameter for an inflation period;

deflating the balloon after the inflation period; and

withdrawing the balloon catheter from the body lumen.

31 . A method for prevention or treatment of stenosis or stricture in a vascular body lumen, the method comprising:

inserting the balloon catheter of claim 24 into a target site in a body lumen comprising the vascular stenosis or stricture;

inflating the balloon at the target site to contact the coating layer with walls of the body lumen at the location of the stenosis or stricture until the balloon achieves an inflated balloon diameter for an inflation period;

deflating the balloon after the inflation period; and

withdrawing the balloon catheter from the body lumen.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 5, 2025
From: GIE MEDICAL, INC.
To: TONIC MEDICAL, INC.
Reel/Frame 072166/0661 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 22, 2021
From: WANG, LIXIAO; BARNETT, PETER
To: GIE MEDICAL, INC.
Reel/Frame 055350/0307 →
Continuity (3)
Provisional Application 63104965 · Oct 23, 2020
Provisional Application 62979980 · Feb 21, 2020
Related Publication 20210259976A1 · Aug 26, 2021
References Cited (400)
US 5171299A · Heitzmann et al. · 1992 [cited by applicant]
US 5263931A · Miller · 1993 [cited by applicant]
US 5312430A · Rosenbluth et al. · 1994 [cited by applicant]
US 5314443A · Rudnick · 1994 [cited by applicant]
US 5419763A · Hildebrand · 1995 [cited by applicant]
US 5423755A · Kesten et al. · 1995 [cited by applicant]
US 5718684A · Gupta · 1998 [cited by applicant]
US 5752522A · Murphy · 1998 [cited by applicant]
US 5904648A · Arndt et al. · 1999 [cited by applicant]
US 6059713A · Urick et al. · 2000 [cited by applicant]
US 6268390B1 · Kunz · 2001 [cited by applicant]
US 6306421B1 · Kunz et al. · 2001 [cited by applicant]
US 6403635B1 · Kinsella et al. · 2002 [cited by applicant]
US 6495579B1 · Hunter · 2002 [cited by applicant]
US 6515009B1 · Kunz et al. · 2003 [cited by applicant]
US 6530948B1 · Vrba · 2003 [cited by applicant]
US 6663881B2 · Kunz et al. · 2003 [cited by applicant]
US 6730064B2 · Ragheb et al. · 2004 [cited by applicant]
US 7803149B2 · Bates et al. · 2010 [cited by applicant]
US 7811622B2 · Bates et al. · 2010 [cited by applicant]
US 7882841B2 · Aljuri et al. · 2011 [cited by applicant]
US 8052668B2 · Sih · 2011 [cited by applicant]
US 8092864B2 · Isch et al. · 2012 [cited by applicant]
US 8241249B2 · Wang · 2012 [cited by applicant]
US 8244344B2 · Wang · 2012 [cited by applicant]
US 8257305B2 · Speck et al. · 2012 [cited by applicant]
US 8366660B2 · Wang · 2013 [cited by applicant]
US 8366662B2 · Wang · 2013 [cited by applicant]
US 8403910B2 · Wang · 2013 [cited by applicant]
US 8404300B2 · Wang · 2013 [cited by applicant]
US 8414525B2 · Wang · 2013 [cited by applicant]
US 8414526B2 · Wang · 2013 [cited by applicant]
US 8414909B2 · Wang · 2013 [cited by applicant]
US 8414910B2 · Wang · 2013 [cited by applicant]
US 8425459B2 · Wang · 2013 [cited by applicant]
US 8430055B2 · Wang et al. · 2013 [cited by applicant]
US 8439868B2 · Speck et al. · 2013 [cited by applicant]
US 8557272B2 · Zhao · 2013 [cited by applicant]
US 8586125B2 · Hossainy et al. · 2013 [cited by applicant]
US 8617611B2 · Burgermeister · 2013 [cited by examiner]
US 8673387B2 · Bates et al. · 2014 [cited by applicant]
US 8722132B2 · Labrecque et al. · 2014 [cited by applicant]
US 9066990B2 · Speck et al. · 2015 [cited by applicant]
US 9180281B2 · Gerrans et al. · 2015 [cited by applicant]
US 9242081B2 · Drasler et al. · 2016 [cited by applicant]
US 9375481B2 · Troiano · 2016 [cited by examiner]
US 9492594B2 · Ahlering · 2016 [cited by examiner]
US 9728840B2 · Shi et al. · 2017 [cited by applicant]
US 9750818B2 · Alargova et al. · 2017 [cited by applicant]
US 10098987B2 · Ahlering et al. · 2018 [cited by applicant]
US 10117972B2 · Mcclain et al. · 2018 [cited by applicant]
US 10188772B2 · Mcclain et al. · 2019 [cited by applicant]
US 10245419B2 · Drasler et al. · 2019 [cited by applicant]
US 10668188B2 · Wang · 2020 [cited by applicant]
US 10675386B2 · Wang · 2020 [cited by applicant]
US 10806830B2 · Wang et al. · 2020 [cited by applicant]
US 10850076B2 · Wang et al. · 2020 [cited by applicant]
US 10881839B2 · Wang et al. · 2021 [cited by applicant]
US 10888640B2 · Wang et al. · 2021 [cited by applicant]
US 10898700B2 · Wang et al. · 2021 [cited by applicant]
US 20030203991A1 · Schottman et al. · 2003 [cited by applicant]
US 20040098019A1 · Tomaschko et al. · 2004 [cited by applicant]
US 20040144387A1 · Amar · 2004 [cited by applicant]
US 20040267355A1 · Scott et al. · 2004 [cited by applicant]
US 20050054978A1 · Segal et al. · 2005 [cited by applicant]
US 20050196518A1 · Stenzel · 2005 [cited by applicant]
US 20050249770A1 · Hunter · 2005 [cited by applicant]
US 20060002852A1 · Saltzman et al. · 2006 [cited by applicant]
US 20060083768A1 · Labrecque et al. · 2006 [cited by applicant]
US 20070005094A1 · Eaton et al. · 2007 [cited by applicant]
US 20070009692A1 · Wang et al. · 2007 [cited by applicant]
US 20070027523A1 · Toner et al. · 2007 [cited by applicant]
US 20070031371A1 · Kozlowski · 2007 [cited by applicant]
US 20070088255A1 · Toner et al. · 2007 [cited by applicant]
US 20080025952A1 · Scheule et al. · 2008 [cited by applicant]
US 20080113035A1 · Hunter · 2008 [cited by applicant]
US 20080118544A1 · Wang · 2008 [cited by applicant]
US 20080175887A1 · Wang · 2008 [cited by applicant]
US 20080245375A1 · Trudel · 2008 [cited by applicant]
US 20080255508A1 · Wang · 2008 [cited by applicant]
US 20080255509A1 · Wang · 2008 [cited by applicant]
US 20080255510A1 · Wang · 2008 [cited by applicant]
US 20080276935A1 · Wang · 2008 [cited by applicant]
US 20080286372A1 · Pacetti et al. · 2008 [cited by applicant]
US 20090018565A1 · To et al. · 2009 [cited by applicant]
US 20090028920A1 · Hodges · 2009 [cited by applicant]
US 20090171241A1 · Garcia et al. · 2009 [cited by applicant]
US 20090283206A1 · Eskaros et al. · 2009 [cited by applicant]
US 20100015200A1 · McClain et al. · 2010 [cited by applicant]
US 20100030183A1 · Toner et al. · 2010 [cited by applicant]
US 20100049182A1 · Ryan et al. · 2010 [cited by applicant]
US 20100055294A1 · Wang et al. · 2010 [cited by applicant]
US 20100076402A1 · Mazzone et al. · 2010 [cited by applicant]
US 20100198150A1 · Michal et al. · 2010 [cited by applicant]
US 20100209472A1 · Wang · 2010 [cited by applicant]
US 20100233228A1 · Speck · 2010 [cited by applicant]
US 20100285085A1 · Stankus et al. · 2010 [cited by applicant]
US 20110008260A1 · Flanagan · 2011 [cited by applicant]
US 20110015664A1 · Kangas et al. · 2011 [cited by applicant]
US 20110022027A1 · Morishita et al. · 2011 [cited by applicant]
US 20110098683A1 · Wiita et al. · 2011 [cited by applicant]
US 20110144578A1 · Pacetti et al. · 2011 [cited by applicant]
US 20110159169A1 · Wang · 2011 [cited by applicant]
US 20110160575A1 · Beyar et al. · 2011 [cited by applicant]
US 20110160658A1 · Wang · 2011 [cited by applicant]
US 20110160660A1 · Wang · 2011 [cited by applicant]
US 20110166548A1 · Wang · 2011 [cited by applicant]
US 20110196340A1 · Barry et al. · 2011 [cited by applicant]
US 20110295200A1 · Speck et al. · 2011 [cited by applicant]
US 20110300221A1 · Kunz et al. · 2011 [cited by applicant]
US 20120029426A1 · Wang · 2012 [cited by applicant]
US 20120035530A1 · Wang · 2012 [cited by applicant]
US 20120109105A1 · Cambronne · 2012 [cited by applicant]
US 20120172796A1 · Chappa · 2012 [cited by applicant]
US 20120231037A1 · Levi et al. · 2012 [cited by applicant]
US 20120239001A1 · Barry et al. · 2012 [cited by applicant]
US 20120296274A1 · Slager · 2012 [cited by applicant]
US 20120302954A1 · Zhao · 2012 [cited by applicant]
US 20120316633A1 · Flanagan et al. · 2012 [cited by applicant]
US 20130190689A1 · Slager · 2013 [cited by applicant]
US 20130197434A1 · Wang · 2013 [cited by applicant]
US 20130231638A1 · Speck et al. · 2013 [cited by applicant]
US 20130245058A1 · Hoffmann et al. · 2013 [cited by applicant]
US 20130253466A1 · Campbell et al. · 2013 [cited by applicant]
US 20130253475A1 · Wang · 2013 [cited by applicant]
US 20130261603A1 · Wang · 2013 [cited by applicant]
US 20130304029A1 · Barry et al. · 2013 [cited by applicant]
US 20140005541A1 · Bates et al. · 2014 [cited by applicant]
US 20140228751A1 · Speck et al. · 2014 [cited by applicant]
US 20140228752A1 · Speck et al. · 2014 [cited by applicant]
US 20140371717A1 · Mcclain et al. · 2014 [cited by applicant]
US 20140378896A1 · Venturelli · 2014 [cited by applicant]
US 20150231375A1 · Kubo et al. · 2015 [cited by applicant]
US 20150273117A1 · Wang · 2015 [cited by applicant]
US 20160038648A1 · Gemborys · 2016 [cited by applicant]
US 20160082159A1 · Orlowski · 2016 [cited by applicant]
US 20160250388A1 · Wang · 2016 [cited by applicant]
US 20160324782A1 · Vail et al. · 2016 [cited by applicant]
US 20160338793A1 · Shohat et al. · 2016 [cited by applicant]
US 20170028105A1 · Ahlering et al. · 2017 [cited by applicant]
US 20170086929A1 · Moll et al. · 2017 [cited by applicant]
US 20170151339A1 · White · 2017 [cited by examiner]
US 20180104383A1 · Wang et al. · 2018 [cited by applicant]
US 20190009063A1 · Cottone et al. · 2019 [cited by applicant]
US 20190015639A1 · Wang et al. · 2019 [cited by applicant]
US 20190015640A1 · Wang et al. · 2019 [cited by applicant]
US 20190046693A1 · Ahlering et al. · 2019 [cited by applicant]
US 20190111187A1 · Steele · 2019 [cited by examiner]
US 20190167854A1 · Wang · 2019 [cited by applicant]
US 20190344053A1 · Wang et al. · 2019 [cited by applicant]
US 20190374685A1 · Wang et al. · 2019 [cited by applicant]
US 20200254148A1 · Wang · 2020 [cited by applicant]
US 20200360571A1 · Wang et al. · 2020 [cited by applicant]
US 20220193310A1 · Labhasetwar · 2022 [cited by applicant]
US 20250082582A1 · Wang et al. · 2025 [cited by applicant]
US 20250213491A1 · Wang et al. · 2025 [cited by applicant]
CN 101610798 · 2009 [cited by applicant]
CN 104936629 · 2015 [cited by applicant]
CN 107405424 · 2017 [cited by applicant]
CN 107635593 · 2018 [cited by applicant]
CN 109414528 · 2019 [cited by applicant]
CN 111166942 · 2020 [cited by applicant]
CN 115461096 · 2022 [cited by applicant]
CN 119236187A · 2025 [cited by applicant]
EP 0474906 · 1992 [cited by applicant]
EP 1135165 · 2001 [cited by applicant]
EP 1143968 · 2003 [cited by applicant]
EP 1539266 · 2008 [cited by applicant]
EP 2292225 · 2012 [cited by applicant]
EP 2098230 · 2012 [cited by applicant]
EP 2262547 · 2013 [cited by applicant]
EP 2324866 · 2014 [cited by applicant]
EP 2324867 · 2014 [cited by applicant]
EP 2531229 · 2014 [cited by applicant]
EP 2451496 · 2015 [cited by applicant]
EP 2911711 · 2015 [cited by applicant]
EP 3442612 · 2020 [cited by applicant]
JP 2010523595A · 2010 [cited by applicant]
JP 2010540159 · 2010 [cited by applicant]
JP 2012502690 · 2012 [cited by applicant]
JP 2013523209 · 2013 [cited by applicant]
JP 2014523790 · 2014 [cited by applicant]
JP 2015536709 · 2015 [cited by applicant]
JP 2016503330 · 2016 [cited by applicant]
JP 2016036730 · 2016 [cited by applicant]
JP 2016518200 · 2016 [cited by applicant]
JP 2017507741 · 2017 [cited by applicant]
JP 2017524467A · 2017 [cited by applicant]
JP 2018517454 · 2018 [cited by applicant]
JP 2019523032 · 2019 [cited by applicant]
JP 2019218354 · 2019 [cited by applicant]
JP 2020049269 · 2020 [cited by applicant]
JP 2020075155 · 2020 [cited by applicant]
JP 2023514737 · 2023 [cited by applicant]
WO 9728840 · 1997 [cited by applicant]
WO 0025848 · 2000 [cited by applicant]
WO 0032238 · 2000 [cited by applicant]
WO 2011147407 · 2001 [cited by applicant]
WO 03072080 · 2003 [cited by applicant]
WO 2009051614 · 2009 [cited by applicant]
WO 2010136604 · 2010 [cited by applicant]
WO 2011008393 · 2011 [cited by applicant]
WO 2011119159 · 2011 [cited by applicant]
WO 2012122023 · 2012 [cited by applicant]
WO 2013015941 · 2013 [cited by applicant]
WO 2013059509 · 2013 [cited by applicant]
WO WO2013059509A1 · 2013 [cited by examiner]
WO 2014066085 · 2014 [cited by applicant]
WO 2014087395 · 2014 [cited by applicant]
WO 2014177678 · 2014 [cited by applicant]
WO 2015103447 · 2015 [cited by applicant]
WO 2015136106 · 2015 [cited by applicant]
WO 2016073294 · 2016 [cited by applicant]
WO 2016118923 · 2016 [cited by applicant]
WO 2016172343 · 2016 [cited by applicant]
WO WO2017049245A2 · 2017 [cited by examiner]
WO 2018204782 · 2018 [cited by applicant]
WO WO2019009809A1 · 2019 [cited by applicant]
WO 2019152811 · 2019 [cited by applicant]
WO 2020172560 · 2020 [cited by applicant]
WO 2021168284 · 2021 [cited by applicant]
F.S.T. Mirakabad, et al. “PLGA-Based Nanoparticles as Cancer Drug Delivery Systems,” Asian Pac J Cancer Prev, 15 (2), 2014 517-535. (Year: 2014). [cited by examiner]
“U.S. Appl. No. 14/438,327, Preliminary Amendment filed Jul. 28, 2015”, 9 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Restriction Requirement mailed Jul. 12, 2016”, 9 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Aug. 24, 2016 to Restriction Requirement mailed Jul. 12, 2016”, 9 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Non Final Office Action mailed Oct. 6, 2016”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Dec. 28, 2016 to Non Final Office Action mailed Oct. 6, 2016”, 13 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Final Office Action mailed May 3, 2017”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Jul. 27, 2017 to Final Office Action mailed May 3, 2017”, 13 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Non Final Office Action mailed Sep. 29, 2017”, 11 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Dec. 15, 2017 to Non Final Office Action mailed Sep. 29, 2017”, 16 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Final Office Action mailed Apr. 2, 2018”, 14 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Jun. 1, 2018 to Final Office Action mailed Apr. 2, 2018”, 16 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Advisory Action mailed Jul. 18, 2018”, 6 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Aug. 1, 2018 to Advisory Action mailed Jul. 18, 2018 and Final Office Action mailed Apr. 2, 2018”, 17 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Restriction Requirement mailed Nov. 2, 2018”, 7 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Response filed Nov. 14, 2018 to Restriction Requirement mailed Nov. 2, 2018”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Non Final Office Action mailed Jan. 28, 2019”, 14 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Restriction Requirement mailed Feb. 8, 2019”, 9 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Notice of Non-Responsive Amendment mailed Mar. 8, 2019”, 2 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Response filed Mar. 20, 2019 to Restriction Requirement mailed Feb. 8, 2019”, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Response filed Mar. 28, 2019 to Notice of Non-Responsive Amendment mailed Mar. 8, 2019”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Apr. 16, 2019 to Non Final Office Action mailed Jan. 28, 2019”, 29 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Notice of Non-Responsive Amendment mailed Jul. 1, 2019”, 2 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Response filed Jul. 9, 2019 to Non-Responsive Amendment mailed Jul. 1, 2019 and Restriction Requirement mailed Feb. 8, 2019”, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Non Final Office Action mailed Jul. 29, 2019”, 38 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Final Office Action mailed Aug. 9, 2019”, 20 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Response filed Aug. 21, 2019 to Non Final Office Action mailed Jul. 29, 2019”, 18 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Non Final Office Action mailed Nov. 18, 2019”, 22 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Final Office Action mailed Nov. 29, 2019”, 41 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Final Office Action mailed Nov. 29, 2019”, 43 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Dec. 3, 2019 to Final Office Action mailed Aug. 9, 2019”, 32 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Non Final Office Action mailed Jan. 7, 2020”, 11 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Response filed Jan. 13, 2020 to Final Office Action mailed Nov. 29, 2019”, 22 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Response filed Feb. 7, 2020 to Non Final Office Action mailed Jan. 7, 2020”, 13 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Response filed Feb. 10, 2020 to Non Final Office Action mailed Nov. 18, 2019”, 17 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Examiner Interview Summary mailed Feb. 12, 2020”, 3 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Non Final Office Action mailed Mar. 5, 2020”, 48 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Response filed Apr. 6, 2020 to Non Final Office Action mailed Mar. 5, 2020”, 21 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Examiner Interview Summary mailed Apr. 8, 2020”, 3 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Notice of Allowance mailed Apr. 22, 2020”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 14/438,327, Corrected Notice of Allowability mailed May 5, 2020”, 3 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Final Office Action mailed May 15, 2020”, 25 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Examiner Interview Summary mailed May 19, 2020”, 4 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Notice of Allowance mailed Jul. 10, 2020”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Response filed Jul. 14, 2020 to Final Office Action mailed May 15, 2020”, 23 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Final Office Action mailed Aug. 21, 2020”, 6 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,436, Corrected Notice of Allowability mailed Sep. 11, 2020”, 7 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Notice of Allowance mailed Sep. 30, 2020”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 15/568,614, Corrected Notice of Allowability mailed Nov. 30, 2020”, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Corrected Notice of Allowability mailed Nov. 30, 2020”, 8 pgs. [cited by applicant]
“37 C.F.R. section 1.132 Declaration for U.S. Appl. No. 16/135,436, filed Jan. 13, 2020”, (2020), 5 pgs. [cited by applicant]
“International Application Serial No. PCT US2013 064842, International Search Report mailed Jan. 17, 2014”, 3 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Extended European Search Report mailed Apr. 28, 2016”, 8 pgs. [cited by applicant]
“International Application Serial No. PCT US2013 064842, Written Opinion mailed Jan. 17, 2014”, 10 pgs. [cited by applicant]
“International Application Serial No. PCT US2013 064842, International Preliminary Report on Patentability mailed May 7, 2015”, 12 pgs. [cited by applicant]
“International Application Serial No. PCT US2016 028652, International Search Report mailed Jul. 26, 2016”, 2 pgs. [cited by applicant]
“International Application Serial No. PCT US2016 028652, Written Opinion mailed Jul. 26, 2016”, 8 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Response filed Sep. 9, 2016 to Office Action mailed May 26, 2016”, (With English Translation), 18 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Response filed Oct. 19, 2015 to Communication pursuant to Rules 161(1) and 162 EPC mailed Jun. 2, 2015”, 17 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Response filed Oct. 14, 2016 to Extended European Search Report mailed Apr. 28, 2016”, 17 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Response filed Feb. 28, 2017 to Office Action mailed Dec. 15, 2016”, w English Claims, 21 pgs. [cited by applicant]
“Japanese Application Serial No. 2015-539651, Office Action mailed Jul. 11, 2017”, w English Translation, 10 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Response filed Sep. 4, 2017 to Office Action mailed Jun. 19, 2017”, w English Claims, 17 pgs. [cited by applicant]
“Japanese Application Serial No. 2015-539651, Response filed Sep. 6, 2017 to Office Action mailed Jul. 11, 2017”, w English claims, 15 pgs. [cited by applicant]
“International Application Serial No. PCT US2016 028652, International Preliminary Report on Patentability mailed Nov. 2, 2017”, 10 pgs. [cited by applicant]
“Japanese Application Serial No. 2015-539651, Examiners Decision of Final Refusal mailed Nov. 21, 2017”, w English Translation, 13 pgs. [cited by applicant]
“Japanese Application Serial No. 2015-539651, Response filed Mar. 20, 2018 to Examiners Decision of Final Refusal mailed Nov. 21, 2017”, w English Claims, 34 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Respone filed Apr. 12, 2018 to Office Action mailed Nov. 27, 2017”, w English Claims, 17 pgs. [cited by applicant]
“Japanese Application Serial No. 2015-539651, Office Action mailed May 15, 2018”, w English Translation, 15 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Communication Pursuant to Article 94(3) EPC mailed Apr. 9, 2018”, 7 pgs. [cited by applicant]
“European Application Serial No. 16783856.4, Response filed Jun. 22, 2018 to Communication pursuant to Rules 161(2) and 162 EPC mailed Dec. 13, 2017”, 11 pgs. [cited by applicant]
“International Application Serial No. PCT US2018 031083, International Search Report mailed Jul. 27, 2018”, 4 pgs. [cited by applicant]
“International Application Serial No. PCT US2018 031083, Written Opinion mailed Jul. 27, 2018”, 33 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Response filed Sep. 14, 2018 to Communication Pursuant to Article 94(3) EPC mailed Apr. 9, 2018”, 42 pgs. [cited by applicant]
“Japanese Application Serial No. 2017-555548, Office Action mailed Aug. 21, 2018”, w English translation, 8 pgs. [cited by applicant]
“Japanese Application Serial No. 2017-555548, Examiners Decision of Final Refusal mailed Mar. 26, 2019”, w English translation, 5 pgs. [cited by applicant]
“European Application Serial No. 16783856.4, Extended European Search Report mailed Nov. 9, 2018”, 7 pgs. [cited by applicant]
“European Application Serial No. 18794752.8, Communication Pursuant to Article 94(3) EPC mailed Apr. 10, 2019”, 8 pgs. [cited by applicant]
“European Application Serial No. 16783856.4, Response filed May 28, 2019 to Extended European Search Report mailed Nov. 9, 2018”, 16 pgs. [cited by applicant]
“European Application Serial No. 18794752.8, Extended European Search Report mailed Mar. 29, 2019”, 5 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Communication Pursuant to Article 94(3) EPC mailed Jun. 4, 2019”, 9 pgs. [cited by applicant]
“Japanese Application Serial No. 2017-555548, Respone filed Jul. 26, 2019 to Examiners Decision of Final Refusal mailed Mar. 26, 2019”, w English Claims, 19 pgs. [cited by applicant]
“European Application Serial No. 18794752.8, Response filed Aug. 5, 2019 to Communication Pursuant to Article 94(3) EPC mailed Apr. 10, 2019”, 55 pgs. [cited by applicant]
“International Application Serial No. PCT US2018 031083, International Preliminary Report on Patentability mailed Nov. 14, 2019”, 35 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Response filed Dec. 16, 2019 to Communication Pursuant to Article 94(3) EPC mailed Jun. 4, 2019”, 30 pgs. [cited by applicant]
“Drug Coated Balloon Catheters for Nonvascular Strictures”. [cited by applicant]
“Chinese Application Serial No. 201680029925.6, Office Action mailed Feb. 21, 2020”, w English translation, 15 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Communication Pursuant to Article 94(3) EPC mailed Apr. 24, 2020”, 8 pgs. [cited by applicant]
“Chinese Application Serial No. 201680029925.6, Response filed Jul. 6, 2020 to Office Action mailed Feb. 21, 2020”, w English Claims, 36 pgs. [cited by applicant]
“International Application Serial No. PCT US2020 019274, International Search Report mailed Jun. 26, 2020”, 6 pgs. [cited by applicant]
“International Application Serial No. PCT US2020 019274, Written Opinion mailed Jun. 26, 2020”, 7 pgs. [cited by applicant]
“Chinese Application Serial No. 201680029925.6, Office Action mailed Jul. 16, 2020”, w English Translation, 22 pgs. [cited by applicant]
“Japanese Application Serial No. 2017-555548, Office Action mailed Aug. 25, 2020”, w English translation, 22 pgs. [cited by applicant]
“European Application Serial No. 13848400.1, Response filed Oct. 19, 2020 to Communication Pursuant to Article 94(3) EPC mailed Apr. 24, 2020”, 13 pgs. [cited by applicant]
“Chinese Application Serial No. 201680029925.6, Office Action mailed Oct. 22, 2020”, w English translation, 25 pgs. [cited by applicant]
“Chinese Application Serial No. 201680029925.6, Response filed Jan. 5, 2021 to Office Action mailed Oct. 22, 2020”, w o English Claims, 6 pgs. [cited by applicant]
Guha, Madhumita, “Effects of acyl chain length, unsaturation, and pH on thermal stability of model discoidal HDLs”, Journal of Lipid Research vol. 49, (2008), 10 pgs. [cited by applicant]
Huang, Weigua, “Effect of transurethral split of the prostate using a double-columnar balloon catheter for benign prostatic hyperplasia”, Medicine 95:40, (Mar. 1, 2016), 4 pgs. [cited by applicant]
Jaidishan, Shishir, “Effect of hydrophobic mismatch and interdigitation on sterol sphingomyelin interaction in ternary bilayer membranes”, Biochimica et Biophysica Acta 1808, (2011), 1940-1945. [cited by applicant]
Kalaji, Nader, “Colloidal and physicochemical characterization of protein-containing PLGA microspheres before and after drying”, e-Polymers 2009, No. 010, (Jan. 2009), 13 pgs. [cited by applicant]
Shiel Jr, William C, “Definition of stricture”, [Online] Retrieved from the internet:https: www.medicinenet.com scriptmain art.asp?articlekey= 166621, (2019), 1 pg. [cited by applicant]
“European Application Serial No. 21712307.4, Response to Communication Pursuant to Rules 161 and 162 filed Apr. 5, 2023”, 30 pgs. [cited by applicant]
Tian, Juanhua, “Rectifying disorder of extracellularmatrix to suppress urethral stricture by protein nanofilm-controlled drug delivery from urinary catheter”, nature communications, (May 17, 2023), 17 pgs. [cited by applicant]
“European Application Serial No. 21712307.4, Communication Pursuant to Article 94(3) EPC mailed Feb. 29, 2024”, 7 pgs. [cited by applicant]
“Japanese application Serial No. 2022-550683, Voluntary Amendment Filed Feb. 16, 2024”, w/ English Claims, 11 pgs. [cited by applicant]
“Chinese Application Serial No. 202180029802.3, Office Action mailed Nov. 7, 2023”, w English Translation, 28 pgs. [cited by applicant]
“International Application Serial No. PCT US2021 018823, Invitation to Pay Additional Fees mailed Jun. 7, 2021”, 14 pgs. [cited by applicant]
“International Application Serial No. PCT US2021 018823, International Search Report mailed Aug. 10, 2021”, 8 pgs. [cited by applicant]
“International Application Serial No. PCT US2021 018823, Written Opinion mailed Aug. 10, 2021”, 12 pgs. [cited by applicant]
Bose, Rajendran JC, “Lipid polymer hybrid nanospheres encapsulating antiproliferative agents for stent applications”, Journal of Industrial and Engineering Chemistry, the Korean Society of Industrial and Engineering Che… [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Office Action mailed May 26, 2016”, w English Translation, 6 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Office Action mailed Dec. 15, 2016”, with English Translation, 20 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Office Action mailed Jun. 19, 2017”, With English Translation, 13 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Office Action mailed Nov. 27, 2017”, W English Translation, 13 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Restriction Requirement mailed Nov. 2, 2018”, 5 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Response filed Nov. 14, 2018 to Restriction Requirement mailed Nov. 2, 2018”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Notice of Non Responsive Amendment mailed Mar. 8, 2019”, 2 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Non Final Office Action mailed Mar. 22, 2019”, 11 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Response filed Mar. 28, 2019 to Notice of Non Responsive Amendment mailed Mar. 8, 2019”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Response Filed Apr. 24, 2019 to Non-Final Office Action Mailed Mar. 22, 2019”, 11 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Final Office Action mailed Jun. 14, 2019”, 15 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Non Final Office Action mailed Jul. 30, 2019”, 40 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Response filed Aug. 21, 2019 to Non Final Office Action mailed Jul. 30, 2019”, 23 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Response filed Sep. 11, 2019 to Final Office Action mailed Jun. 14, 2019”, 17 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,720, Restriction Requirement mailed Oct. 18, 2019”, 5 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,720, Response filed Oct. 31, 2019 to Restriction Requirement mailed Oct. 18, 2019”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Non Final Office Action mailed Nov. 18, 2019”, 19 pgs. [cited by applicant]
“Chinese Application Serial No. 201380055869.X, Notice of Reexamination mailed Nov. 21, 2019”, w English Translation, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,677, Restriction Requirement mailed Nov. 20, 2019”, 5 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,677, Response filed Dec. 13, 2019 to Restriction Requirement mailed Nov. 20, 2019”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Response filed Jan. 13, 2020 to Final Office Action mailed Nov. 29, 2019”, 27 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,720, Non Final Office Action mailed Feb. 6, 2020”, 23 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Response filed Feb. 13, 2020 to Non Final Office Action mailed Nov. 18, 2019”, 17 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Non Final Office Action mailed Mar. 19, 2020”, 56 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,677, Non Final Office Action mailed Mar. 19, 2020”, 31 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Final Office Action mailed Mar. 30, 2020”, 18 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Response filed Mar. 31, 2020 to Final Office Action mailed Mar. 30, 2020”, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Notice of Allowance mailed Apr. 22, 2020”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,720, Response filed May 6, 2020 to Non Final Office Action mailed Feb. 6, 2020”, 19 pgs. [cited by applicant]
“U.S. Appl. No. 16/267,434, Corrected Notice of Allowability mailed May 13, 2020”, 3 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Response filed May 15, 2020 to Non Final Office Action mailed Mar. 19, 2020”, 29 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,677, Response filed Jun. 19, 2020 to Non Final Office Action mailed Mar. 19, 2020”, 19 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,720, Final Office Action mailed Aug. 21, 2020”, 23 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Response filed Sep. 4, 2020 to Final Office Action mailed Aug. 21, 2020”, 12 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,720, Response filed Sep. 4, 2020 to Final Office Action mailed Aug. 21, 2020”, 12 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,677, Notice of Allowance mailed Sep. 21, 2020”, 10 pgs. [cited by applicant]
“U.S. Appl. No. 16/135,472, Notice of Allowance mailed Oct. 7, 2020”, 9 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,720, Notice of Allowance mailed Oct. 21, 2020”, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/986,683, Non Final Office Action mailed Oct. 29, 2020”, 14 pgs. [cited by applicant]
“U.S. Appl. No. 16/864,373, Restriction Requirement mailed Nov. 17, 2020”, 5 pgs. [cited by applicant]
“U.S. Appl. No. 16/519,677, Corrected Notice of Allowability mailed Nov. 30, 2020”, 7 pgs. [cited by applicant]
“U.S. Appl. No. 16/986,683, Response filed Dec. 4, 2020 to Non Final Office Action mailed Oct. 29, 2020”, 9 pgs. [cited by applicant]
“U.S. Appl. No. 16/864,373, Response filed Dec. 10, 2020 to Restriction Requirement mailed Nov. 17, 2020”, 7 pgs. [cited by applicant]
“U.S. Appl. No. 17/133,088, Preliminary Amendment filed Dec. 29, 2020”, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/986,683, Notice of Allowance mailed Jan. 4, 2021”, 9 pgs. [cited by applicant]
Daughtry, “Balloon Dilation of the Ureter: A Means to Facilitate Passage of Ureteral and Renal Calculi”, The Journal of Urology, vol. 136, (1986), 1063-1065. [cited by applicant]
Daughtry, “Balloon dilation of urethral strictures”, Urology, vol. 31, (1988), 231-233. [cited by applicant]
Goldenberg, S L, “Balloon Dilatation of the Prostate”, Alternate Methods in the Treatment of Benign Prostatic Hyperplasia, (1993), 97-119. [cited by applicant]
Vale, Ja, “Balloon dilatation of the prostate-should it have a place in the urologist's armamentarium?”, Journal of the Royal Society of Medicine vol. 86, (Feb. 1993), pp. 83-86. [cited by applicant]
“Japanese Application Serial No. 2017-555548, Response filed Nov. 20, 2018 to Office Action mailed Aug. 21, 2018”, w English Claims, 11 pgs. [cited by applicant]
“Japanese Application Serial No. 2018-052874, Office Action mailed Jan. 29, 2019”, w English translation, 15 pgs. [cited by applicant]
“Japanese Application Serial No. 2018-563611, Notification of Reasons for Refusal mailed Apr. 23, 2019”, w English translation, 7 pgs. [cited by applicant]
“Japanese Application Serial No. 2018-052874, Response filed May 14, 2019 to Office Action mailed Jan. 29, 2019”, w English Claims, 24 pgs. [cited by applicant]
“PMA P130024: FDA Summary of Safety and Effectiveness Data (SSED)”, Retrieved from the Internet:URL:https: www.accessdata.fda.gov cdrh_docs pdf13 P130024b.pdf, 44 pgs. [cited by applicant]
“Stricture”, definition accessed online on Jun. 10, 2019, [Online] Retrieved from the internet:www.merriam-webster.com dictionary stricture, (2019), 1 pg. [cited by applicant]
“Japanese Application Serial No. 2018-563611, Response filed Jul. 22, 2019 to Notification of Reasons for Refusal mailed Apr. 23, 2019”, w English Claims, 14 pgs. [cited by applicant]
“Japanese Application Serial No. 2018-563611, Notification of Reasons for Refusal mailed Aug. 20, 2019”, w English translation, 7 pgs. [cited by applicant]
“Japanese Application Serial No. 2018-052874, Office Action mailed Oct. 1, 2019”, w English translation, 6 pgs. [cited by applicant]
“Japanese Application Serial No. 2019-137680, Notification of Reasons for Rejection mailed Jul. 21, 2020”, W English Translation, 5 pgs. [cited by applicant]
“Japanese Application Serial No. 2019-137680, Response filed Oct. 6, 2020 to Notification of Reasons for Rejection mailed Jul. 21, 2020”, w English Translation, 5 pgs. [cited by applicant]
Aaron, Latayia, “Review of Prostate Anatomy and Embryology and the Etiology of BPH”, Urol Clin North Am 43(3), (Aug. 2016), pp. 279-288. [cited by applicant]
Donatucci, Craig F, “Randomized Clinical Trial Comparing Balloon Dilatation to Transurethral Resection of Prostate for Benign Prostatic Hyperplasia”, Adult Urology vol. 4 2, No. 1, (Jul. 1993), 42-49. [cited by applicant]
Lukacs, B, “One-year follow-up of 2829 patients with moderate to severe lower urinary tract symptoms treated with alt uzosin in general practice according to IPSS and a health-related quality-of-life questionnaire”, BPM… [cited by applicant]
Milonas, Daimantas, “The effect of complete transurethral resection of the prostate on symptoms, quality of life, and voiding function improvement”, Central European Journal of Urology, (2015), pp. 169-174. [cited by applicant]
Oesterling, Joseph E, “The Origin and Development of Benign Prostatic Hyperplasia an Age-Dependent Process”, Journal of Andrology, vol. 12, No. 6,, (1991), 8 pgs. [cited by applicant]
Pekker, M, “The surface charge of a cell lipid membrane”, J Phys Chem Biophys 5, (2015), 15 pgs. [cited by applicant]
Roehrborn, C G, “Pathology of benign prostatic hyperplasia”, International Journal of Impotence Research 20, (2008), S11-S18. [cited by applicant]
Shin, “Tissue Hyperplasia: Influence of a Paclitaxel-eluting Covered Stent-Preliminary Study in a Canine Urethral Model”, Radiology, (2005), 438-444. [cited by applicant]
Szule, Joseph A, “The Effects of Acyl Chain Length and Saturation of Diacylglycerols and Phosphatidylcholines on Membrane Monolayer Curvature”, Biophysical Journal vol. 83, (Aug. 2002), 977-984. [cited by applicant]