DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The examiner acknowledges receipt of preliminary amendment filed 04/14/2025 and IDS filed 10/23/2024.
Claims 1-32 are canceled.
New claims 33-52 are added and pending.
Priority
The examiner acknowledges this application as a Continuation of 17/721,183 filed 04/14/2022, now US 12133915 B2, and which is a Continuation of 17/244,963 filed
04/30/2021, now US 11717479 B2, and which is a Continuation of 16/469,143 filed 06/12/2019 now US 11241383 B2, which is a 371 of PCT/US17/65347 filed 12/08/2017, and which claims benefit of 62/432,353 filed 12/09/2016 and 62/485,281 filed 04/13/2017.
Information Disclosure Statement
The IDS filed 10/23/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 33-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (US 20130156823 Al) in view of Herink (Herink, J., "Effect of alprazolam and ketamine on seizures induced by two different convulsants," Acta Medica (Hradec Krazlove) 1997, 40(1), 9-11), Cross (US 2005/0268911 Al) and Haut et al. (Haut et al., "Benzodiazepine use in seizure emergencies: A systematic review," Epilepsy & Behavior, 63 (2016), 109-117) (available online September 6, 2016) and further in view of Zaffaroni et al., (US 20100181387 Al).
Wu teaches that inhaled benzodiazepines, including alprazolam, can be used to treat seizures (abstract, paragraphs [0005], [0011], [0034]-[0036], [0039]) with inhaled or inhalation meeting the method of claim 33 as an administration method. Wu further teaches that these benzodiazepines can not only be used for treating seizures that have progressed to status epilepticus but, in addition, many other types of seizures (including the treatment of acute symptoms) (paragraphs [0033], [0035]). Further, it would be prima facie obvious to administer alprazolam as quickly as possible to help minimize the amount of pain/discomfort suffered by the patient undergoing the seizure and also to help minimize any potentially life threatening medical complications; and Mortality from status epilepticus can be as high as 40% (paragraphs [0005], [0033]). Wu also teaches particle sizes that are less than 5 microns, which reads on dependent claim 51 as less than 2 microns and less than 5 microns are prima facie obvious over less than 5 microns of Wu (claims 1, 3, 7; paragraphs [0037], [0044] and [0047]).
Wu differs from the claimed invention in that alprazolam is one of the drugs in a Markush listing and thus not specifically exemplified for the treatment of seizures. Wu also fails to teach the device is activated by a single breath of the subject and delivers the alprazolam aerosol to the lung of the subject.
Herink provides a specific example of alprazolam being used to treat seizures (title, abstract, first full paragraph of page 10 and Fig. 1). Thus, Herink reinforces the teaching of Wu and Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and alprazolam is a benzodiazepine (see Haut, section 3.4 of page 112, Fig. 3).
Herink and Haut reinforce the teaching that Alprazolam may be administered at different times (i.e., are not limited to seizures that have progressed to status epilepticus) (section on Materials and Methods of Herink; sections 3.2, 3.3, Fig. 2). .
Cross teaches a breath-activated inhalation device (Figs. 3, 5 7 and 8). For example, Cross teaches that "resistive heating elements" can be used to vaporize a substance/drug disposed on a metal foil (paragraphs [0005], [0056], [0060], [0061], [0069], claim 35, Figs. 3, 8 and 11). Further, Cross teaches that these heating elements can be used to vaporize drugs, including alprazolam, on a heat-conductive, impermeable substrate (paragraphs [0062], [0067], [0075] and claim 42). Cross also teaches that the substrate can be heated rapidly up to at least 400°C (paragraphs [0062], [0079], Examples 2, 5 and 9).
Cross also teaches the use of a mouthpiece (paragraphs [0005], [0056], [0046], [0048], [0052], [0082], [0095], claims 33, 35, 37 and 82, Fig. 3); Cross describes the inhalation device as being breath-activated (paragraph [0056]) as the subject places mouthpiece 56 of condensation aerosol delivery device 100 into his or her mouth, the subject inhales on the mouthpiece 56 to generate airflow (paragraph [0050], second shell 54, actuation mechanism 67 of Fig. 3).
The mean peak plasma concentration Cmax of at least 12 ng alprazolam/ml plasma and at least 30 ng alprazolam/ml plasma recited in claims 33 and 34 is achieved after administration of the dose of 1-2 mg alprazolam through aerosol inhalation.
Accordingly, for claims 33 and 34, it would have been prima facie obvious to treat patients undergoing seizures in order to stop those seizures with alprazolam as taught by the combined teachings of Wu, Herink, and Haut using the breath-activated inhalation device as described by Cross in order to administer the drug quickly, safely and efficiently (paragraph [0035] of Wu). The inhalation devices of Cross would also be beneficial insofar as they are portable and light weight (paragraph [0059]). A person of ordinary skill would have reasonably expected to be successful using the apparatus of Cross with alprazolam for the treatment of seizures because Cross expressly states that the drug alprazolam can be used in their device for the treatment of patients requiring inhalation as the route of administration (paragraph [0075], claim 42).
With respect to dose of about 1 mg to about 2 mg alprazolam, Zaffaroni in 2010 teaches aerosol delivery of alprazolam (see at least the title) and the dose administered by the aerosol is between 0.05 and 4 mg and preferably between 0.1 mg and 2 mg (see paragraph [0142]). Therefore, at the effective date of the invention, the artisan will look to Zaffaroni for dose of alprazolam that could be administered by aerosol.
For claims 35-36, Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and where alprazolam is a benzodiazepine (section 3.4 of page 112, Fig. 3).
For claims 37-40 and 45-46, Wu teaches acute repetitive seizures (paragraph [0033]) as one form of seizures treated.
For claims 41-42, Wu (paragraph [0033]) and Haut (at least the introduction) contemplate treating prolonged persistent seizures.
For claims 43-44, Wu teaches treating acute repetitive seizures
(paragraph [0033]) and Wu (paragraph [0033]) and Haut (at least the introduction) contemplate
treating prolonged persistent seizures. Aura phase is a form of seizures. Before the effective date of the invention, the ordinary skilled artisan would reasonably expect that administration of alprazolam by inhalation would predictably treat seizures including aura phase seizure after inhalation of the alprazolam. Inhalation from a mouthpiece is self-administration.
For claims 47-48, Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and where alprazolam is a benzodiazepine (section 3.4 of page 112, Fig. 3). Because the seizure being treated is not a prolonged state of persistent seizure (status epilepticus), and acute repetitive seizures occur over short periods of time , such as 24 hours (paragraph [0033] of Wu), it is reasonable to expect absence of seizure event 6 hours after administration.
For claims 49 and 50, instant claims 33 and 34 upon which claims 49 and 50 depend, the dose administered is between 1 and 2 mg alprazolam. The bioavailability of the alprazolam from the 1-2 mg alprazolam is said to be about 80-125% or more achieved (claim 49) and 90-110% or more achieved (claim 50). Zaffaroni in 2010 teaches aerosol delivery of alprazolam (see at least the title) and the dose administered by the aerosol is between 0.05 and 4 mg and preferably between 0.1 mg and 2 mg (see paragraph [0142]). Therefore, before the effective date of the invention, the administration of 0.1 mg alprazolam would inherently lead to bioavailability of the alprazolam of about 80-125% or more (claim 49) and 90-110% or more (claim 50) with the same dose of alprazolam administered intravenously.
For claim 51, Wu also teaches particle sizes that are less than 5 microns, which reads on dependent claim 51 as less than 2 microns and less than 5 microns are prima facie obvious over less than 5 microns of Wu (claims 1, 3, 7; paragraphs [0037], [0044] and [0047]).
For claim 52, Cross teaches that the thickness of the layer of the substance is from 0.1 mm to 10 mm (paragraph [0063]) which is the claimed range of 0.1 mm to 10 mm.
Wu in view of Herink, Cross and Haut and further in view of Zaffaroni renders claims 33-52 prima facie obvious.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 33-52 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 and 8-10 of U.S. Patent No. 7585493 B2 in view of Wu et al. (US 20130156823 Al) in view of Herink (Herink, J., "Effect of alprazolam and ketamine on seizures induced by two different convulsants," Acta Medica (Hradec Krazlove) 1997, 40(1), 9-11), Cross (US 2005/0268911 Al) and Haut et al. ("Haut et al., "Benzodiazepine use in seizure emergencies: A systematic review," Epilepsy & Behavior, 63 (2016), 109-117) (available online September 6, 2016) and further in view of Zaffaroni et al., (US 20100181387 Al).
US 7585493 B2 teaches a device that comprises alprazolam having a film thickness of
0.1-10 mm, the device comprises a surface having a film comprising an alprazolam drug film
having a thickness of 0.1-10 mm, aerosol formed by vaporizing the drug composition by heating
element and condensing the vaporized drug composition (issued claim 1) and issued claims 8-10
teach method of forming human therapeutic inhalation dose of a drug composition aerosol, the
method comprising heating the substrate to 300 °C to 500 °C to vaporize the drug such as
alprazolam having a film thickness of 0.1-10 mm, gas flows across the substrate to produce the
desired aerosol particles by condensation; the vaporization takes place within 2 seconds.
Issued Claims 1 and 8-10 do not teach the claimed method.
Wu teaches that inhaled benzodiazepines, including alprazolam, can be used to treat
seizures (abstract, paragraphs [0005], [0011], [0034]-[0036], [0039]) in particle form. Wu also
teaches particle sizes that are less than 5 microns (which reads on dependent claim 51) (claims 1,
3, 7; paragraphs [0037], [0044] and [0047]). Herink provides a specific example of alprazolam
being used to treat seizures (title, abstract, first full paragraph of page 10 and Fig. 1). Thus,
Herink reinforces the teaching of Wu. Haut teaches that alprazolam can be used to treat seizures
and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a
benzodiazepine and alprazolam, a benzodiazepine (section 3.4 of page 112, Fig. 3).
Cross teaches a breath-activated inhalation device with the first, second and third claimed
elements (Figs. 3, 5 7 and 8). For example, with respect to the first element, Cross teaches that
"resistive heating elements" can be used to vaporize a substance/drug disposed on a metal foil
(paragraphs [0005], [0056], [0060], [0061], [0069], claim 35, Figs. 3, 8 and 11). Further, Cross
teaches that these heating elements can be used to vaporize drugs, including alprazolam, on a
heat-conductive, impermeable substrate (paragraphs [0062], [0067], [0075] and claim 42). Cross also teaches that the substrate can be heated rapidly up to at least 400°C (paragraphs
[0062], [0079], Examples 2, 5 and 9). Cross teaches the use of a mouthpiece (paragraphs [0005], [0056], [0046], [0048], [0052], [0082], [0095], claims 33, 35, 37 and 82, Fig. 3).
Herink and Haut also reinforce the teaching that Alprazolam may be administered at
different times (i.e., are not limited to seizures that have progressed to status epilepticus) (section
on Materials and Methods of Herink; sections 3.2, 3.3, Fig. 2).
It would have been prima facie obvious to treat patients undergoing seizures (in order to
stop the seizure with alprazolam as taught by the combined teachings of US 7,585,493 B2,
Wu, Herink, and Haut using the breath-activated inhalation device as described by Hale in order
to administer the drug quickly, safely and efficiently (paragraph [0035] of Wu).
Herink, and Haut using the breath-activated inhalation device as described by Cross in
order to administer the drug quickly, safely and efficiently (paragraph [0035] of Wu. The
inhalation devices of Cross would also be beneficial insofar as they are portable and light weight
(paragraph [0059]). A person of ordinary skill would have reasonably expected to be successful
using the apparatus of Cross with alprazolam for the treatment of seizures because Cross
expressly states that the drug alprazolam can be used in their device for the treatment of patients
requiring inhalation as the route of administration (paragraph [0075], claim 42).
For claims 35-36, Haut teaches that alprazolam can be used to treat seizures and Haut
expressly teaches that seizures can be stopped within 2 minutes of administration of a
benzodiazepine and alprazolam, a benzodiazepine (section 3.4 of page 112, Fig. 3).
For claim 51, Wu also teaches particle sizes that are less than 5 microns (which reads
on claim 51 as less than 2 micron (claim 15) and less than 5 micron (claims 13-14) are prima facie obvious over less than 5 microns of Wu (claims 1, 3, 7; paragraphs [0037], [0044]
and [0047]).
For claim 52, Cross teaches that the thickness of the layer of the substance is from 0.1 mm to 10 mm (paragraph [0063]) which is the claimed range of 0.1 mm to 10 mm.
For claims 35-36, Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and where alprazolam is a benzodiazepine (section 3.4 of page 112, Fig. 3).
For claims 37-40 and 45-46, Wu teaches acute repetitive seizures (paragraph [0033]) as one form of seizures treated.
For claims 41-42, Wu (paragraph [0033]) and Haut (at least the introduction) contemplate treating prolonged persistent seizures.
For claims 43-44, Wu teaches treating acute repetitive seizures
(paragraph [0033]) and Wu (paragraph [0033]) and Haut (at least the introduction) contemplate
treating prolonged persistent seizures. Aura phase is a form of seizures. Before the effective date of the invention, the ordinary skilled artisan would reasonably expect that administration of alprazolam by inhalation would predictably treat seizures including aura phase seizure after inhalation of the alprazolam. Inhalation from a mouthpiece is self-administration.
For claims 47-48, Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and where alprazolam is a benzodiazepine (section 3.4 of page 112, Fig. 3). Because the seizure being treated is not a prolonged state of persistent seizure (status epilepticus), and acute repetitive seizures occur over short periods of time , such as 24 hours (paragraph [0033] of Wu), it is reasonable to expect absence of seizure event 6 hours after administration.
For claims 49 and 50, instant claims 33 and 34 upon which claims 49 and 50 depend, the dose administered is between 1 and 2 mg alprazolam. The bioavailability of the alprazolam from the 1-2 mg alprazolam is said to be about 80-125% or more achieved (claim 49) and 90-110% or more achieved (claim 50). Zaffaroni in 2010 teaches aerosol delivery of alprazolam (see at least the title) and the dose administered by the aerosol is between 0.05 and 4 mg and preferably between 0.1 mg and 2 mg (see paragraph [0142]). Therefore, before the effective date of the invention, the administration of 0.1 mg alprazolam would inherently lead to bioavailability of the alprazolam of about 80-125% or more (claim 49) and 90-110% or more (claim 50) with the same dose of alprazolam administered intravenously.
The device of issued claim 1 and 8-10 as modified by Wu in combination with Herink, Cross and Haut and further in view of Zaffaroni renders examined claims 33-52 prima facie obvious.
Claims 33-52 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11511054 B2 in view of Wu et al. (US 20130156823 Al) in view of Herink (Herink, J., "Effect of alprazolam and ketamine on seizures induced by two different convulsants," Acta Medica (Hradec Krazlove) 1997, 40(1), 9-11), Cross (US 2005/0268911 Al) and Haut et al. ("Haut et al., "Benzodiazepine use in seizure emergencies: A systematic review," Epilepsy & Behavior, 63 (2016), 109-117) (available online September 6, 2016) and further in view of Zaffaroni et al., (US 20100181387 Al).
US 11511054 B2 teaches method for producing drug condensation aerosol of alprazolam;
the alprazolam is heated to a temperature of at least 300 °C to vaporize the alprazolam within 2
seconds, the vaporized alprazolam condenses to aerosolized particles having less than 5 microns (meeting examined claim 51). Issued claim 1 teaches device having the same limitations of heating temperature of at least 300 °C to vaporize the alprazolam within 2 seconds. For the examined claims, the artisan would reasonably expect that administration of the alprazolam after the onset of the ongoing seizure or during the ongoing seizure would predictably treat seizures.
Issued claims 1 and 9 do not teach the claimed method.
For claims 33 and 34, Wu teaches that inhaled benzodiazepines, including alprazolam, can be used to treat seizures (abstract, paragraphs [0005], [0011], [0034]-[0036], [0039]) in particle form. Wu also teaches particle sizes that are less than 5 microns (which reads examined claim 51) (claims 1, 3, 7; paragraphs [0037], [0044] and [0047]). Herink provides a specific example of alprazolam being used to treat seizures (title, abstract, first full paragraph of page 10 and Fig. 1). Thus, Herink reinforces the teaching of Wu. Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and alprazolam, a benzodiazepine (section 3.4 of page 112, Fig. 3).
Cross teaches a breath-activated inhalation device with the first, second and third claimed
elements (Figs. 3, 5 7 and 8). For example, with respect to the first element, Cross teaches that
"resistive heating elements" can be used to vaporize a substance/drug disposed on a metal foil
(paragraphs [0005], [0056], [0060], [0061], [0069], claim 35, Figs. 3, 8 and 11). Further, Cross
teaches that these heating elements can be used to vaporize drugs, including alprazolam, on a
heat-conductive, impermeable substrate (paragraphs [0062], [0067], [0075] and claim
42). Cross also teaches that the substrate can be heated rapidly up to at least 400°C (paragraphs
[0062], [0079], Examples 2, 5 and 9). Cross teaches the use of a mouthpiece (paragraphs [0005], [0056], [0046], [0048], [0052], [0082], [0095], claims 33, 35, 37 and 82, Fig. 3).
Herink and Haut also reinforce the teaching that Alprazolam may be administered at
different times (i.e., are not limited to seizures that have progressed to status epilepticus) (section
on Materials and Methods of Herink; sections 3.2, 3.3, Fig. 2).
It would have been prima facie obvious to treat patients undergoing seizures (in order to
stop the seizure with alprazolam as taught by the combined teachings of US 7,585,493 B2,
Wu, Herink, and Haut using the breath-activated inhalation device as described by Hale in order to administer the drug quickly, safely and efficiently (paragraph [0035] of Wu). Herink, and Haut using the breath-activated inhalation device as described by Cross in order to administer the drug quickly, safely and efficiently (paragraph [0035] of Wu. The
inhalation devices of Cross would also be beneficial insofar as they are portable and light weight
(paragraph [0059]). A person of ordinary skill would have reasonably expected to be successful
using the apparatus of Cross with alprazolam for the treatment of seizures because Cross
expressly states that the drug alprazolam can be used in their device for the treatment of patients
requiring inhalation as the route of administration (paragraph [0075], claim 42).
For claims 35-36, Haut teaches that alprazolam can be used to treat seizures and Haut
expressly teaches that seizures can be stopped within 2 minutes of administration of a
benzodiazepine and alprazolam, a benzodiazepine (section 3.4 of page 112, Fig. 3).
For claim 51, Wu also teaches particle sizes that are less than 5 microns (which reads
on claim 51 as less than 2 micron (claim 15) and less than 5 micron (claims 13-14) are prima facie obvious over less than 5 microns of Wu (claims 1, 3, 7; paragraphs [0037], [0044]
and [0047]).
For claim 52, Cross teaches that the thickness of the layer of the substance is from 0.1 mm to 10 mm (paragraph [0063]) which is the claimed range of 0.1 mm to 10 mm.
For claims 35-36, Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and where alprazolam is a benzodiazepine (section 3.4 of page 112, Fig. 3).
For claims 37-40 and 45-46, Wu teaches acute repetitive seizures (paragraph [0033]) as one form of seizures treated.
For claims 41-42, Wu (paragraph [0033]) and Haut (at least the introduction) contemplate treating prolonged persistent seizures.
For claims 43-44, Wu teaches treating acute repetitive seizures
(paragraph [0033]) and Wu (paragraph [0033]) and Haut (at least the introduction) contemplate
treating prolonged persistent seizures. Aura phase is a form of seizures. Before the effective date of the invention, the ordinary skilled artisan would reasonably expect that administration of alprazolam by inhalation would predictably treat seizures including aura phase seizure after inhalation of the alprazolam. Inhalation from a mouthpiece is self-administration.
For claims 47-48, Haut teaches that alprazolam can be used to treat seizures and Haut expressly teaches that seizures can be stopped within 2 minutes of administration of a benzodiazepine and where alprazolam is a benzodiazepine (section 3.4 of page 112, Fig. 3). Because the seizure being treated is not a prolonged state of persistent seizure (status epilepticus), and acute repetitive seizures occur over short periods of time , such as 24 hours (paragraph [0033] of Wu), it is reasonable to expect absence of seizure event 6 hours after administration.
For claims 49 and 50, instant claims 33 and 34 upon which claims 49 and 50 depend, the dose administered is between 1 and 2 mg alprazolam. The bioavailability of the alprazolam from the 1-2 mg alprazolam is said to be about 80-125% or more achieved (claim 49) and 90-110% or more achieved (claim 50). Zaffaroni in 2010 teaches aerosol delivery of alprazolam (see at least the title) and the dose administered by the aerosol is between 0.05 and 4 mg and preferably between 0.1 mg and 2 mg (see paragraph [0142]). Therefore, before the effective date of the invention, the administration of 0.1 mg alprazolam would inherently lead to bioavailability of the alprazolam of about 80-125% or more (claim 49) and 90-110% or more (claim 50) with the same dose of alprazolam administered intravenously.
The device of issued claim 1 and 8-10 as modified by Wu in combination with Herink, Cross and Haut and further in view of Zaffaroni renders examined claims 33-52 prima facie obvious.
The product produced by issued claims 1 and 9 as modified by Wu in combination with Herink, Cross and Haut and further in view of Zaffaroni renders examined claims 33-52 prima facie obvious.
Claims 33-52 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-34; 1-37; and 1-35 of U.S. Patent Nos. 12133915 B2; 11717479 B2; and 11241383 B2 respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims teach method for stopping ongoing seizure in a subject (12122915 B2), method of treating epileptic seizure in a subject (11717479 B2), and method of treating epilepsy in a subject (11241383 B3) by delivering aerosolized alprazolam by inhalation to the subject to achieve stopping/treating the epileptic seizure and where the seizure has not progressed to status epilepticus.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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