IP Library Granted Patent US 12,329,899
Granted Patent B2
US 12,329,899 · App. 15/701,257 · Granted Jun 17, 2025

Dry powder inhaler and methods of use

Inventor: Kambiz Yadidi (Los Angeles, CA)
Assignee: ASPEYA US INC.
A61M15/0045A61K31/616A61M2202/064
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 12,329,899
App. No.
15/701,257
Granted
Jun 17, 2025
Kind
B2
Abstract

Methods for reducing the risk of a thromboembolic event, and a related drug delivery system are provided. In some embodiments, a dose of acetylsalicylic acid can be provided in powder form to a patient using a dry powder inhaler. The dose can be effective to reduce a risk of a thromboembolic event in a patient. A dry powder inhaler used for the method can have a mouthpiece, a reservoir for receiving the dose of acetylsalicylic acid, and an actuation member for making available the dose of acetylsalicylic acid for inhalation by a patient through the mouthpiece.

Claims (29)

1. A method of reducing a risk of a thromboembolic event in a patient in an emergency, the method comprising:

administering through oral inhalation to the patient a dose of a dry powder consisting essentially of acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof, and, optionally, at least one carrier, particles of the dry powder having a median geometric diameter in a range of from 1 μm to 5 μm,

wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof in the dose is in a range of from 1 mg to less than 80 mg.

2. The method of claim 1 , wherein the dose has less than 75 mg of the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof.

3. The method of claim 1 , wherein the administering is a preliminary treatment in response to a symptom of the thromboembolic event.

4. The method of claim 1 , wherein the median geometric diameter is in a range of from 1.7 μm to 2.7 μm.

5. The method of claim 1 , wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof in the dose administered is bioequivalent to an oral dose in a range of from 81 mg to 325 mg of acetylsalicylic acid.

6. The method of claim 1 , which treats a pulmonary embolism.

7. The method of claim 1 , wherein the acetylsalicylic acid is present in the dry powder.

8. The method of claim 1 , wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof in the dose is in a range of from 2 mg to 60 mg.

9. The method of claim 1 , wherein the particles are spheroidal and have a sponge-like morphology.

10. A drug delivery system for reducing a risk of a thromboembolic event in an emergency, the system comprising:

a dose of a dry powder consisting essentially of acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof, and, optionally, at least one carrier, particles of the dry powder having a median geometric diameter in a range of from 1 μm to 5 μm; and

a dry powder inhaler suitable for oral inhalation,

wherein the dose has the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof in a range of from 1 mg to less than 80 mg, wherein the dry powder inhaler comprises a mouthpiece and a reservoir suitable for receiving the dose.

11. The system of claim 10 , wherein the dose has less than 75 mg of the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof.

12. The system of claim 10 , wherein the median geometric diameter is in a range of from 1.7 μm to 2.7 μm.

13. The system of claim 10 , wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof in the dose is in a range of from 2 mg to 60 mg.

14. The system of claim 10 , wherein the particles are spheroidal and have a sponge-like morphology.

15. A method of reducing a risk of a thromboembolic event in a patient in an emergency, the method comprising:

administering through oral inhalation to the patient a dose of a dry powder consisting of acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof, and, optionally, at least one carrier, particles of the dry powder having a median geometric diameter in a range of from 1 μm to 5 μm,

wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof in the dose is in a range of from 1 mg to less than 80 mg.

16. The method of claim 15 , wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof in the dose is in a range of from 2 mg to 60 mg.

17. The method of claim 15 , wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof is present in the dry powder in a range of from 2 mg to 30 mg.

18. The method of claim 15 , wherein the particles are spheroidal and have a sponge-like morphology.

19. The method of claim 15 , wherein the dry powder consists of particles of the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof and the at least one carrier.

20. The method of claim 15 , wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof is administered in only a single dose.

21. The method of claim 15 , wherein the dry powder consists of particles consisting of the acetylsalicylic acid and one carrier.

22. The method of claim 15 , wherein the acetylsalicylic acid and/or at least one pharmaceutically acceptable salt thereof is not administered in a single dose.

Assignments (3)
CHANGE OF NAME Recorded May 12, 2025
From: VECTURA INC.
To: ASPEYA US INC.
Reel/Frame 071251/0047 →
CONFIRMATION OF ASSIGNMENT Recorded Apr 24, 2023
From: OTITOPIC INC.
To: VECTURA INC.
Reel/Frame 063448/0621 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 15, 2018
From: YADIDI, KAMBIZ
To: OTITOPIC INC.
Reel/Frame 047519/0493 →
Continuity (4)
Continuation 13843285 · Mar 15, 2013
Continuation In Part 13791734 · Mar 8, 2013
Provisional Application 61740407 · Dec 20, 2012
Related Publication 20180064890A1 · Mar 8, 2018
References Cited (317)
US 3906950A · Cozza · 1975 [cited by applicant]
US 4353365A · Hallworth et al. · 1982 [cited by applicant]
US 4885287A · Hussain · 1989 [cited by applicant]
US 4995385A · Valentini et al. · 1991 [cited by applicant]
US 5256538A · Aiken et al. · 1993 [cited by applicant]
US 5327883A · Williams et al. · 1994 [cited by applicant]
US 5366967A · Bianco · 1994 [cited by examiner]
US 5506203A · Backstrom et al. · 1996 [cited by applicant]
US 5518998A · Backstrom et al. · 1996 [cited by applicant]
US 5639441A · Sievers et al. · 1997 [cited by applicant]
US 5673686A · Villax et al. · 1997 [cited by applicant]
US 5750559A · Bianco · 1998 [cited by applicant]
US 5855913A · Hanes et al. · 1999 [cited by applicant]
US 5874064A · Edwards et al. · 1999 [cited by applicant]
US 5875776A · Vaghefi · 1999 [cited by examiner]
US 6051256A · Platz et al. · 2000 [cited by applicant]
US 6051566A · Bianco · 2000 [cited by applicant]
US 6098620A · Lloyd et al. · 2000 [cited by applicant]
US 6136295A · Edwards et al. · 2000 [cited by applicant]
US 6136346A · Eljamal et al. · 2000 [cited by applicant]
US 6187344B1 · Eljamal et al. · 2001 [cited by applicant]
US 6254854B1 · Edwards et al. · 2001 [cited by applicant]
US 6257233B1 · Burr · 2001 [cited by examiner]
US 6284282B1 · Maa et al. · 2001 [cited by applicant]
US 6309623B1 · Weers et al. · 2001 [cited by applicant]
US 6358530B1 · Eljamal et al. · 2002 [cited by applicant]
US 6408846B1 · Ohki et al. · 2002 [cited by applicant]
US 6423344B1 · Platz et al. · 2002 [cited by applicant]
US 6455028B1 · Wulffhart et al. · 2002 [cited by applicant]
US 6503480B1 · Edwards et al. · 2003 [cited by applicant]
US 6516950B1 · Robertson · 2003 [cited by examiner]
US 6561186B2 · Casper et al. · 2003 [cited by applicant]
US 6565885B1 · Tarara et al. · 2003 [cited by applicant]
US 6569406B2 · Stevenson et al. · 2003 [cited by applicant]
US 6592904B2 · Platz et al. · 2003 [cited by applicant]
US 6630169B1 · Bot et al. · 2003 [cited by applicant]
US 6638495B2 · Weers et al. · 2003 [cited by applicant]
US 6652837B1 · Edwards et al. · 2003 [cited by applicant]
US 6705313B2 · Niccolai · 2004 [cited by applicant]
US 6732732B2 · Edwards et al. · 2004 [cited by applicant]
US 6737042B2 · Rabinowitz et al. · 2004 [cited by applicant]
US 6766799B2 · Edwards et al. · 2004 [cited by applicant]
US 6848197B2 · Chen et al. · 2005 [cited by applicant]
US 6880555B1 · Brunnberg et al. · 2005 [cited by applicant]
US 6881398B2 · Myrman et al. · 2005 [cited by applicant]
US 6884794B2 · Staniforth et al. · 2005 [cited by applicant]
US 6893657B2 · Roser et al. · 2005 [cited by applicant]
US 6979437B2 · Bartus et al. · 2005 [cited by applicant]
US 6994842B2 · Lee et al. · 2006 [cited by applicant]
US 6998137B2 · Shih et al. · 2006 [cited by applicant]
US 7025059B2 · Pera · 2006 [cited by applicant]
US 7089934B2 · Staniforth et al. · 2006 [cited by applicant]
US 7146978B2 · Edwards et al. · 2006 [cited by applicant]
US 7189750B2 · Assaf et al. · 2007 [cited by applicant]
US 7201929B1 · Finkelstein · 2007 [cited by applicant]
US 7205343B2 · Dellamary et al. · 2007 [cited by applicant]
US 7267813B2 · Watanabe et al. · 2007 [cited by applicant]
US 7278425B2 · Edwards et al. · 2007 [cited by applicant]
US 7284553B2 · Hochrainer · 2007 [cited by applicant]
US 7306787B2 · Tarara et al. · 2007 [cited by applicant]
US 7405207B2 · Leonard et al. · 2008 [cited by applicant]
US 7431916B2 · Nilsson et al. · 2008 [cited by applicant]
US 7435720B2 · Quay et al. · 2008 [cited by applicant]
US 7516741B2 · Glusker et al. · 2009 [cited by applicant]
US 7521068B2 · Bosch et al. · 2009 [cited by applicant]
US 7534914B2 · Koike et al. · 2009 [cited by applicant]
US 7541022B2 · Staniforth et al. · 2009 [cited by applicant]
US 7556035B2 · Young et al. · 2009 [cited by applicant]
US 7556798B2 · Edwards et al. · 2009 [cited by applicant]
US 7559325B2 · Dunkley et al. · 2009 [cited by applicant]
US 7628978B2 · Weers et al. · 2009 [cited by applicant]
US 7651770B2 · Berkland et al. · 2010 [cited by applicant]
US 7669596B2 · Alston · 2010 [cited by applicant]
US 7682614B2 · Strober et al. · 2010 [cited by applicant]
US 7744906B2 · Coates · 2010 [cited by applicant]
US 7790145B2 · Weers et al. · 2010 [cited by applicant]
US 7806117B2 · Tsutsui · 2010 [cited by applicant]
US 7878193B2 · Kladders et al. · 2011 [cited by applicant]
US 7919119B2 · Straub et al. · 2011 [cited by applicant]
US 7954491B2 · Hrkach · 2011 [cited by applicant]
US 8069851B2 · Dunkley et al. · 2011 [cited by applicant]
US 8075919B2 · Brown et al. · 2011 [cited by applicant]
US 8114438B2 · Pipkin et al. · 2012 [cited by applicant]
US 8168223B1 · Tarara et al. · 2012 [cited by applicant]
US 8173168B2 · Platz et al. · 2012 [cited by applicant]
US 8201555B2 · Chawla · 2012 [cited by applicant]
US 8236786B2 · Finch et al. · 2012 [cited by applicant]
US 8246934B2 · Weers et al. · 2012 [cited by applicant]
US 8530463B2 · Cartt et al. · 2013 [cited by applicant]
US 8561609B2 · Donovan et al. · 2013 [cited by applicant]
US 8623419B2 · Malakhov et al. · 2014 [cited by applicant]
US 8771744B2 · Ruecroft et al. · 2014 [cited by applicant]
US 8790648B2 · Tocker et al. · 2014 [cited by applicant]
US 8795634B2 · Illum et al. · 2014 [cited by applicant]
US 8940683B2 · Levitt · 2015 [cited by applicant]
US 8985102B2 · Hodson et al. · 2015 [cited by applicant]
US 8997799B2 · Hodson et al. · 2015 [cited by applicant]
US 9051302B2 · Winssinger et al. · 2015 [cited by applicant]
US 9061352B2 · Lipp et al. · 2015 [cited by applicant]
US 9085632B2 · Coates et al. · 2015 [cited by applicant]
US 9101539B2 · Nagata et al. · 2015 [cited by applicant]
US 9125999B2 · Rolfs et al. · 2015 [cited by applicant]
US 9138407B2 · Caponetti et al. · 2015 [cited by applicant]
US 20020025917A1 · Pappalardo · 2002 [cited by applicant]
US 20020033174A1 · Lecourt · 2002 [cited by examiner]
US 20020094318A1 · Lee · 2002 [cited by examiner]
US 20020128179A1 · Tacon · 2002 [cited by examiner]
US 20020158150A1 · Matsugi · 2002 [cited by examiner]
US 20030000518A1 · Rabinowitz · 2003 [cited by examiner]
US 20030176421A1 · Watson et al. · 2003 [cited by applicant]
US 20030186843A1 · Staniforth et al. · 2003 [cited by applicant]
US 20030232019A1 · Basu et al. · 2003 [cited by applicant]
US 20040024013A1 · Asai · 2004 [cited by examiner]
US 20040024057A1 · Earl · 2004 [cited by examiner]
US 20040049022A1 · Nyce et al. · 2004 [cited by applicant]
US 20040092470A1 · Leonard et al. · 2004 [cited by applicant]
US 20040105821A1 · Bernstein et al. · 2004 [cited by applicant]
US 20040156790A1 · Rabinowitz · 2004 [cited by examiner]
US 20040206350A1 · Alston et al. · 2004 [cited by applicant]
US 20040235802A1 · Gimona · 2004 [cited by examiner]
US 20050000518A1 · Dunkley et al. · 2005 [cited by applicant]
US 20050004079A1 · Benjamin et al. · 2005 [cited by applicant]
US 20050084528A1 · Saeed et al. · 2005 [cited by applicant]
US 20050148555A1 · Gupta et al. · 2005 [cited by applicant]
US 20050180926A1 · Lecourt et al. · 2005 [cited by applicant]
US 20050249697A1 · Uhrich et al. · 2005 [cited by applicant]
US 20060002995A1 · Harwigsson · 2006 [cited by applicant]
US 20060030550A1 · Lithgow et al. · 2006 [cited by applicant]
US 20060257987A1 · Gonzalez Valcarcel et al. · 2006 [cited by applicant]
US 20060293217A1 · Barker et al. · 2006 [cited by applicant]
US 20070021382A1 · Assaf · 2007 [cited by applicant]
US 20070072939A1 · Kupper · 2007 [cited by applicant]
US 20070116761A1 · Desai et al. · 2007 [cited by applicant]
US 20070123477A1 · Malcolmson · 2007 [cited by examiner]
US 20070123571A1 · Raj et al. · 2007 [cited by applicant]
US 20070160661A1 · Finkelstein · 2007 [cited by examiner]
US 20070178166A1 · Bernstein et al. · 2007 [cited by applicant]
US 20070232575A1 · Baulieu et al. · 2007 [cited by applicant]
US 20080066741A1 · LeMahieu et al. · 2008 [cited by applicant]
US 20080127972A1 · Morton · 2008 [cited by examiner]
US 20080226736A1 · Caponetti et al. · 2008 [cited by applicant]
US 20080306033A1 · Franzone · 2008 [cited by examiner]
US 20090011030A1 · Jouhikainen et al. · 2009 [cited by applicant]
US 20090110679A1 · Li et al. · 2009 [cited by applicant]
US 20090136561A1 · Von Rechenberg et al. · 2009 [cited by applicant]
US 20090220435A1 · Quay et al. · 2009 [cited by applicant]
US 20090308392A1 · Smutney et al. · 2009 [cited by applicant]
US 20090312380A1 · Becker · 2009 [cited by applicant]
US 20100108058A1 · Glusker · 2010 [cited by examiner]
US 20100132705A1 · De Vos · 2010 [cited by applicant]
US 20100158819A1 · Kligerman et al. · 2010 [cited by applicant]
US 20100168710A1 · Braithwaite · 2010 [cited by applicant]
US 20100234442A1 · Duarte-Vazquez et al. · 2010 [cited by applicant]
US 20100242960A1 · Zangerle · 2010 [cited by applicant]
US 20100258118A1 · Morton · 2010 [cited by applicant]
US 20100316724A1 · Whitfield et al. · 2010 [cited by applicant]
US 20100319694A1 · Cook et al. · 2010 [cited by applicant]
US 20110112134A1 · Hutchinson et al. · 2011 [cited by applicant]
US 20110123626A1 · Weers · 2011 [cited by examiner]
US 20110142914A1 · Persaud et al. · 2011 [cited by applicant]
US 20110146678A1 · Ruecroft et al. · 2011 [cited by applicant]
US 20110166133A1 · Albaugh et al. · 2011 [cited by applicant]
US 20110189106A1 · Danzig et al. · 2011 [cited by applicant]
US 20110250130A1 · Benatuil et al. · 2011 [cited by applicant]
US 20110263610A1 · Wan et al. · 2011 [cited by applicant]
US 20110277752A1 · Cheu et al. · 2011 [cited by applicant]
US 20120017892A1 · Ludwig · 2012 [cited by examiner]
US 20120046251A1 · Schaefer et al. · 2012 [cited by applicant]
US 20120064126A1 · Sung et al. · 2012 [cited by applicant]
US 20120125325A1 · Bannister et al. · 2012 [cited by applicant]
US 20120132203A1 · Hodson et al. · 2012 [cited by applicant]
US 20120145150A1 · Donovan et al. · 2012 [cited by applicant]
US 20120152245A1 · Rolfs et al. · 2012 [cited by applicant]
US 20120263680A1 · Lander et al. · 2012 [cited by applicant]
US 20120276193A1 · Graversen et al. · 2012 [cited by applicant]
US 20120291780A1 · Donovan et al. · 2012 [cited by applicant]
US 20120308566A1 · Martin et al. · 2012 [cited by applicant]
US 20120309809A1 · Green et al. · 2012 [cited by applicant]
US 20130004969A1 · Peschon et al. · 2013 [cited by applicant]
US 20130028942A1 · Surber et al. · 2013 [cited by applicant]
US 20130213397A1 · Curtis · 2013 [cited by examiner]
US 20130316001A1 · Popov et al. · 2013 [cited by applicant]
US 20140065219A1 · Bosch · 2014 [cited by examiner]
US 20140079784A1 · Burnier et al. · 2014 [cited by applicant]
US 20140174437A1 · Yadidi · 2014 [cited by applicant]
US 20140174440A1 · Yadidi · 2014 [cited by applicant]
US 20140213560A1 · Vakkalanka · 2014 [cited by applicant]
US 20140234330A1 · Budelsky et al. · 2014 [cited by applicant]
US 20140239525A1 · McConville et al. · 2014 [cited by applicant]
US 20140242174A1 · Walker · 2014 [cited by applicant]
US 20140322238A1 · Budelsky et al. · 2014 [cited by applicant]
US 20140322328A1 · Yadidi · 2014 [cited by applicant]
US 20140364837A1 · Boyes et al. · 2014 [cited by applicant]
US 20150005230A1 · Eliasof · 2015 [cited by applicant]
US 20150045332A1 · Swenson · 2015 [cited by applicant]
US 20150050713A1 · Malakhov et al. · 2015 [cited by applicant]
US 20150059746A1 · Green · 2015 [cited by applicant]
US 20150093338A1 · Farber · 2015 [cited by applicant]
US 20150132386A1 · Heng et al. · 2015 [cited by applicant]
US 20150136130A1 · Dehaan et al. · 2015 [cited by applicant]
US 20150224129A1 · Trottein et al. · 2015 [cited by applicant]
US 20150239866A1 · Machacek et al. · 2015 [cited by applicant]
US 20150239966A1 · Baciu et al. · 2015 [cited by applicant]
US 20150239987A1 · Liang et al. · 2015 [cited by applicant]
US 20150284381A1 · Andresen et al. · 2015 [cited by applicant]
US 20150320694A1 · Gu et al. · 2015 [cited by applicant]
US 20150322070A1 · Rao et al. · 2015 [cited by applicant]
CN 1388762 · 2003 [cited by applicant]
CN 1491109 · 2004 [cited by applicant]
CN 102058886 · 2011 [cited by applicant]
EP 0499143A2 · 1992 [cited by examiner]
EP 1177805 · 2002 [cited by applicant]
EP 1238680 · 2002 [cited by applicant]
EP 1350511 · 2003 [cited by applicant]
EP 1814521 · 2007 [cited by applicant]
EP 1350511B1 · 2008 [cited by applicant]
GB 2434754 · 2007 [cited by applicant]
JP H4500070 · 1992 [cited by applicant]
JP 2002255814 · 2002 [cited by applicant]
JP 2003525081 · 2003 [cited by applicant]
JP 2004509141 · 2004 [cited by applicant]
JP 2009537199 · 2009 [cited by applicant]
WO WO9300951 · 1993 [cited by applicant]
WO WO9511666 · 1995 [cited by applicant]
WO 9737708A1 · 1997 [cited by applicant]
WO 2000027359 · 2000 [cited by applicant]
WO WO2002024158 · 2002 [cited by applicant]
WO 03047598 · 2003 [cited by applicant]
WO 03047628 · 2003 [cited by applicant]
WO 2005040163 · 2005 [cited by applicant]
WO 2005041886 · 2005 [cited by applicant]
WO 2006017354 · 2006 [cited by applicant]
WO 2007072503 · 2007 [cited by applicant]
WO 2009089822 · 2009 [cited by applicant]
WO 2012061902 · 2012 [cited by applicant]
WO 2012107364 · 2012 [cited by applicant]
WO 2012107765 · 2012 [cited by applicant]
WO 2013004999 · 2013 [cited by applicant]
WO 2014131851 · 2014 [cited by applicant]
WO 2014155103 · 2014 [cited by applicant]
WO 2015002703 · 2015 [cited by applicant]
WO 2015011244 · 2015 [cited by applicant]
WO 2015054574 · 2015 [cited by applicant]
WO 2015127315 · 2015 [cited by applicant]
WO 2015148415 · 2015 [cited by applicant]
WO 2015153838 · 2015 [cited by applicant]
WO 2015155544 · 2015 [cited by applicant]
Keller, Developments and trends in pulmonary drug delivery, Chemistry today, 1998. [cited by examiner]
Miser, Appropriate use for primary prevention of cardiovascular disease, Editorials: controversies in family medicine 2011. [cited by examiner]
Kallmann et al., Effects of low doses of aspirin, 10 mg and 30 mg daily, on bleeding time, thromboxane production and 6-keto PGF1 alpha excretion in healthy subjects, Thromb Res, 1987. [cited by examiner]
WebMD, Heart attack signs, symptoms and emergency treatment 2011. [cited by examiner]
Eikelboom et al., Antiplatelet Drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, Chest, vol. 141, Issue 2, Supplement, … [cited by examiner]
Diener et al., European Stroke Prevention Study 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke, Journal of the Neurological Sciences, vol. 143, Issues 1-2, 1996, pp. 1-13, ISSN 0022-510X,… [cited by examiner]
Algra, et al., “Aspirin at Any Dose Above 30 mg Offers Only Modest Protection After Cerebral Ischaemia,” J of Neurology, Neurosurgery & Psychiatry, 1996, 60:197-199. [cited by applicant]
Asprin Dosage-Drugs, www.druigs.com, Dec. 2011. [cited by applicant]
“Aspirin”, Martindale: The Complete Drug Reference, 33rd ed., 2002 Pharmaceutical press, pp. 14-18. [cited by applicant]
ATT Collaboration, “Aspirin in the Primary and Secondary Prevention of Vascular Disease: Collaborative Meta-Analysis of Individual Participant Data from Randomised Trials,” The Lancet, 2009, 373:1849-1860. [cited by applicant]
Awa, et al., “Prediction of time-dependent interaction of aspirin with ibuprofen using a pharmacokinetic/pharmacodynamics model,” Journal of Clinical Pharmacy and Therapeutics, 2012, vol. 37, pp. 469-474. [cited by applicant]
Boysen, et al., “Danish Very-low-dose Aspirin After Carotid Endarterectomy Trial,” Stroke, 1988, 19:1211-1215. [cited by applicant]
Chew, et al., “The Role of Particle Properties in Pharmaceutical Powder Inhalation Formulations,” Journal of Aerosol Medicine, 2002, vol. 15, No. 3, pp. 325-330. [cited by applicant]
Christen, et al., “Low-dose Aspirin and Risk of Cataract and Subtypes in a Randomized Trial of U.S. Physicians” Ophthalmic Epidemiology, 1998, vol. 5, No. 3, pp. 133-142. [cited by applicant]
European Search Report dated Jul. 18, 2016 corresponding to European Application No. 13864747.4; 6 pages. [cited by applicant]
Fehri, et al., “Bioavailability of Acetylsalicylic Acid Administered Orally or Rectally in the Rabbit,” J. Pharma Belg, 1989, vol. 44, No. 1, pp. 5-10. [cited by applicant]
Geller, et al., “Development of an Inhaled Dry-Powder Formulation of Tobramycin Using PlumoSphere Technology,” J Aerosol Med Pulm Drug Deliv, Aug. 2011, 24(4), pp. 175-182. [cited by applicant]
Hadinoto et al., “Drug Release Study of Large Hollow Nanoparticulate Aggregates Carrier Particles for Pulmonary Delivery,” International Journal of Pharmaceutics 341 (2007) 195-206. [cited by applicant]
Hadinoto, et al., “Dry powder aerosol delivery of large hollow nanoparticulate aggregates as prospective carriers of nanoparticulate drugs: Effects of phospholipids,” International Journal of Pharmaceuticals, Oct. 2006,… [cited by applicant]
Hovens et al., Aspirin in the prevention and treatment of venous thromboembolism, Journal of Thrombosis and Haemostasis, 2006; 4: 1470-5. [cited by applicant]
Hovione TwinCaps Dry Powder Inhaler, <http://www.hovione.com/twincaps/twincaps.asp>, visited Aug. 2013. [cited by applicant]
Hovione—Particle Design Technologies, <http://www.hovione.com/pd/particledesigntechnologies.asp>, visited Aug. 2013. [cited by applicant]
“Internal Analgesic: Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use: Final Rule for Professional Labeling of Aspirin, Buffered Aspirin, and Aspirin in Combination with Antacid Drug Products,… [cited by applicant]
Iwamoto, “Gastrointestinal and Hepatic First-Pass Metabolism of Aspirin in Rats,” J Pharm Pharmacol. Mar. 1982; 34(3), pp. 176-180. [cited by applicant]
Jaffe, et al., “Recovery of Endothelial Cell Prostacyclin Production after Inhibition by Low Doses of Aspirin,” The American Society for Clinical Investigation, Inc., Mar. 1979, vol. 63, pp. 532-535. [cited by applicant]
Kim, et al., “Airway Responsiveness to Inhaled Aspirin is Influenced by Airway Hyperresponsiveness in Asthmatic Patients,” Korean J Intern Med, Sep. 2010; 25(3): 309-316. [cited by applicant]
Kupczyk, et al. “Lipoxin A4 Generation Is Decreased in Aspirin-Sensitive Patients in Lysine-Aspirin Nasal Challenge in Vivo Model”, Allergy (Oxford, United Kingdom) (2009), 64(12), 1746-1752. [cited by applicant]
Kurth, et al., “Inhibition of Clinical Benefits of Aspirin on First Myocardial Infarction by Nonsteroidal Antiinflammatory Drugs,” Circulation, 2003, 108:1191-1195. [cited by applicant]
Miser, Appropriate Aspirin Use for Primary Prevention of Cardiovascular Disease, Editorials: Controversies in Family Medicine, 2011. [cited by applicant]
Phillips et al., “Inhaled Lysine-Aspirin as a Bronchoprovocation Procedure in Aspirin-Sensitive Asthma: its Repeatability, Absence of a Late-Phase Reaction, and the Role of Histamine,” J Allergy Clin Immunol, Aug. 1989;… [cited by applicant]
Press release by Activaero GmbH, Dec. 19, 2006, <http://www.pharmaloco.com/news.sub.—detail/Activaero+and+Group+of+Re- saerchers+Receive+Grant+for+Develop/14009/index.html>. [cited by applicant]
“Physicians' Health Study I,” <http://phs.bwh.harvard.edu/phs1.htm>, Mar. 2009. [cited by applicant]
Rocca, et al., “Variability in the Responsiveness to Low-Dose Aspirin: Pharmacological and Disease-Related Mechanisms,” Thrombosis, 2012, 11 pages. [cited by applicant]
Roth, et al., “Aspirin, Platelets, and Thrombosis: Theory and Practice,” Blood, Feb. 15, 1994, vol. 83, No. 4, pp. 885-898. [cited by applicant]
Sestini et al., “Different Effects of Inhaled Aspirin-like Drugs on Allergen-Induced Early and Late Asthmatic Responses,” Am J Respir Grit Care Med, Apr. 1, 1999 vol. 159 No. 4 1228-1233. [cited by applicant]
Sestini, et al., “Protective Effect of Inhaled Lysine Acetylsalicylate on Allergen-Induced Early and Late Asthmatic Reactions,” J Allergy Clin Immunol, 1997 vol. 100, pp. 71-77. [cited by applicant]
Soleti et al., “Aspirin Inhalation Treatment for COPD Patients: Preliminary Studies on PK and Inflammatory Biomarkers,” Thematic Poster Session, P825, Drug delivery and pharmacokinetics I, Sep. 25, 2011, p. 138s. [cited by applicant]
Sung, et al., “Nanoparticles for Drug Delivery to the Lungs,” Trends in Biotechnology, 2007, vol. 25, No. 12. [cited by applicant]
The Dutch TIA Trial Study Group, “A Comparison of Two Doses of Aspirin (30 mg vs. 283 mg a day) in Patients After a Transient Ischemic Attack or Minor Ischemic Stroke,” The New England Journal of Medicine, 1991, vol. 32… [cited by applicant]
WebMD Heart Attack; 2011. [cited by applicant]
Canadian Intellectual Property Office, “First Office Action”, for Canadian Application No. 2,895,398, dated Nov. 8, 2016, 4 pgs. [cited by applicant]
Canadian Intellectual Property Office, “Second Office Action”, for Canadian Application No. 2,895,398, dated Sep. 27, 2017, 4 pgs. [cited by applicant]
European Patent Office, “Official Action (Article 94(3)) EPC”, for EP13864747.4, dated Oct. 5, 2017, 4 pgs. [cited by applicant]
IP Australia, “First Examination Report”, for AU 2013205497, dated Aug. 19, 2014, 4 pgs. [cited by applicant]
IP Australia, “Second Examination Report”, for AU 2013205497, dated Nov. 9, 2015, 3 pgs. [cited by applicant]
IP Australia, “First Examination Report”, for AU 2016213728, dated Oct. 12, 2017, 4 pgs. [cited by applicant]
Japanese Patent Office, “First Office Action” for JP 2015-549353 with English translation, dated Aug. 1, 2016 6 pgs. [cited by applicant]
Japanese Patent Office, “Second Office Action” for JP 2015-549353, dated Apr. 19, 2017, 5 pgs. [cited by applicant]
State Intellectual Property Office of China PRC, “First Office Action” for CN 201380073320.3 (English translation), dated Aug. 11, 2016, 6 pgs. [cited by applicant]
State Intellectual Property Office of China PRC, “Second Office Action” for CN 201380073320.3 with partial English translation, dated May 3, 2017, 6 pgs. [cited by applicant]
USPTO, “International Search Report and Written Opinion” for international application No. PCT/US2013/032597, dated Jun. 11, 2013, 7 pgs. [cited by applicant]
Office Action dated Nov. 3, 2016, in co-pending U.S. Appl. No. 13/791,734. [cited by applicant]
Stroke Prevention in Atrial Fibrillation Investigators (“Risk factors for thromboembolism during aspirin therapy in patients with atrial fibrillation: the stroke prevention in atrial fibrillation study”, J Stroke Cerebr… [cited by applicant]
Aspirin the mighty drug (year 2007). [cited by applicant]
Barnett et al., Aspirin Dose in Stroke Prevention, Stroke, 1996; 27:588. [cited by applicant]
Office Actions dated Dec. 8, 2021, in co-pending U.S. Appl. No. 16/370,932. [cited by applicant]
Office Actions dated Apr. 27, 2023, in co-pending U.S. Appl. No. 16/370,932. [cited by applicant]
Office Action with a mailing date of Jun. 30, 2016 on the corresponding Japanese Patent Application No. 2015-549353 (with Machine English translation). [cited by applicant]
Office Action with a mailing date of Mar. 22, 2018 on the corresponding Japanese Patent Application No. 2015-549353 (with Machine English translation). [cited by applicant]
Notice of Allowance with a mailing date of Sep. 5, 2018 on the corresponding Japanese Patent Application No. 2015- 549353 (with Machine English translation). [cited by applicant]
Office Action with a mailing date of May 3, 2017 on the corresponding Chinese Patent Application No. 201380073320.3 (with Machine English translation). [cited by applicant]
Extended European Search Report with a mailing date of Sep. 29, 2023, issued in corresponding Application No. EP 23 16 4415.4 (reference 24 cited therein). [cited by applicant]
Anne Van Hecken, PhD et al.; “Comparative Inhibitory Activity of Rofecoxib, Meloxicam, Diclofenac, Ibuprofen, and Naproxen on COX-2 versus COX-1 in Healthy Volunteers”, The Journal of Clinical Pharmacology, Lippincott C… [cited by applicant]
Patrono, C. et al., “Low-Dose Aspirin for the Prevention of Atherothrombosis”, New England Journal of Medicine, 2005, pp. 2373-2383. [cited by applicant]
Swarbrick, J., “Encyclopedia of Pharmaceutical Technology”, New York, USA: Informa Healthcare, 2007, Ed. Third—pp. 1279-1286 and cover pages. [cited by applicant]
Dai, Y et al., “Clinical Use of Aspirin in Treatment and Prevention of Cardiovascular Disease”, Thrombosis, vol. 2012, Article ID 245037, 2021, pp. 1-7. [cited by applicant]
British National Formulary “British National Formulary 61” BMJ Group and Pharmaceutical Press, 2011 - pp. 149-152 and cover pages. [cited by applicant]
Patentee's letter dated Mar. 9, 2021, and enclosure “Exhibit C” filed during examination, 8 pages. [cited by applicant]
Aulton M.E., “Pharmaceutics: The Science of Dosage Form Design”, Churchill Livingstone, 2022, Ed. Second, 18 pages. [cited by applicant]
Proof of online publication of D5 on Nov. 24. 2011, available from: https://www.ncbi.nlm.nih.gov/pms/articles/PMC3236445. [cited by applicant]