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 .
Information Disclosure Statement
The submitted information disclosure statements (IDSs) were filed on 04/09/2024 and 02/17/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim(s) 31-35, 46 and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over DE 20219665 U1 and Frank et al. (WO 2013188979 A1) in view of McNeely et al. (McNeely et al. Intranasal Azelastine. A Review of its Efficacy in the Management of Allergic Rhinitis. Drugs 1998 Jul; 56 (1): 91-114) and Bagger et al. (Bagger et al., A microdialysis model to examine nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride as a model drug. International Journal of Pharmaceutics 269 (2004) 311–322).
DE 20219665 U1 teaches that treating obesity causally and symptomatically in one medication by creating a feeling of satiety, administering to respective individual and comparing the use of the combination drugs can improve the effectiveness of the therapy (pg. 3, 5th par.). A composition for inducing satiety and treating obesity in animals, (Abs), comprising active ingredient(s) antiallergics/antihistamines azelastine, (pg. 8, 4th par.), local anesthetics lidocaine, (pg. 11, 8th last par.) and excipient(s) pectins (pg. 3, 1st par.), methylcellulose or carboxymethylcellulose (pg. 7, 4th par.).
Frank et al. teach therapeutic agents include anesthetics, appetite suppressants (00159), antihistamines like azelastine, (00161). The composition is administered intranasally to target the nasal mucosa, (00209). The composition is selected from pectin, carboxymethylcellulose. (Claim 5). Pharmaceutical compositions and formulations for topical administration generally include gels, drops, sprays. (00179).
McNeely et al. teach azelastine, is a second-generation histamine H1 receptor antagonist which has shown clinical efficacy in relieving the symptoms of allergic rhinitis when administered as intranasal formulation. It is thought to improve both the early and late phase symptoms of rhinitis through a combination of antihistaminic, antiallergic and anti-inflammatory mechanisms. Symptom improvements are evident as early as 30 minutes after intranasal administration of azelastine [2 puffs per nostril (0.56mg)] and are apparent for up to 12 hours in patients with seasonal allergic rhinitis (SAR). (Abs). In short, Azelastine has the efficacy effects last temporary. Azelastine salt form can be used is azelastine hydrochloride. (pg. 101, Table II; pg. 110, right col., 3rd. par.).
Bagger et al. teach targeting of the central nervous system by direct drug transport from the nose to the brain. Lidocaine hydrochloride for olfactory drug absorption has been investigated using intravenous and unilateral nasal administration of in rats. 6mg lidocaine dosed intranasal last about 120 min measured by lidocaine concentrations by microdialysis in blood, left striatum and right striatum, respectively, (pg. 317, Fig. 1a), which means its effects last temporary.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to treat obesity causally and symptomatically in one medication by creating a feeling of satiety, by administering to respective individual active ingredient(s) antiallergics/antihistamines azelastine, local anesthetics lidocaine, with excipient(s) pectins, methylcellulose or carboxymethylcellulose, taught by DE 20219665 U1, for intranasal spray taught by Frank et al, and azelastine can be salt form azelastine hydrochloride to have its concentrations lasted up to 12 hrs to have its effect, taught by McNeely et al. and lidocaine can be salt lidocaine hydrochloride, with its concentrations lasted up to 120 mins, to have its effects taught by Bagger et al., since they have proven it would be possible to do so.
With regard to claims 46,
McNeely et al. teach Azelastine nasal spray is supplied as a 1 mg/ml solution of azelastine hydrochloride in a metered dose pump spray bottle. (pg. 110, right col., 3rd par.). A nasal spray with a pump is designed to aerosolize its liquid medication creating a fine mist or spray that delivers the drug into the nasal passages, transforming the liquid into small airborne particles (aerosols) for easier inhalation and absorption.
Claims 36-47, have limitations of compositions, which are not properties of process limitations, so they are not linked to the limitations of independent claim 31 which claims a process for temporary suppression of appetite in a subject.
Claim(s) 31 and 36-39 s/are rejected under 35 U.S.C. 103 as being unpatentable over DE 20219665 U1 and Frank et al. (WO 2013188979 A1) in view of McNeely et al. (McNeely et al. Intranasal Azelastine. A Review of its Efficacy in the Management of Allergic Rhinitis. Drugs 1998 Jul; 56 (1): 91-114) and Bagger et al. (Bagger et al., A microdialysis model to examine nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride as a model drug. International Journal of Pharmaceutics 269 (2004) 311–322) and further in view of Chugh et al. (Chugh et al., Intranasal drug delivery: a novel approach. Indian J Otolaryngol Head Neck Surg. (April–June 2009) 61:90–94).
The teachings of DE 20219665 U1, Frank et al., McNeely et al. and Bagger et al. are described in claim 31 above that to treat obesity creating a feeling of short-term satiety by administering to the subject active ingredient(s) antiallergics/antihistamines azelastine, local anesthetics lidocaine, with excipient(s).
DE 20219665 U1, Frank et al, McNeely et al. and Bagger et al. do not teach pH of the pharmaceutical composition is between about 4 and about 5.
Chugh et al. teach small molecules and macro molecules being studied for nasal delivery, including antihistamines like azelastine and central nervous system drug like lidocaine. (pg. 92, Table 1). pH of the drug formulation is also important for absorption since nasal irritation is
minimized when products are delivered at pH 4.5–6.5. (pg. 91, right col., 2nd last par.). Also, pHs are composition/formulation properties and they are not process properties, so pHs of the composition/formulation are not linked with motivation to suppress appetite process.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to treat obesity causally and symptomatically in one medication by creating a feeling of satiety, by administering to respective individual active ingredient(s) antiallergics/antihistamines azelastine, local anesthetics lidocaine, with excipient(s) pectins, methylcellulose or carboxymethylcellulose, taught by DE 20219665 U1, for intranasal spray taught by Frank et al, and azelastine can be salt form azelastine hydrochloride to have its concentrations lasted up to 12 hrs to have its effect, taught by McNeely et al. and lidocaine can be salt lidocaine hydrochloride, with its concentrations lasted up to 120 mins to have its effects taught by Bagger et al., and to have the pH of the intranasal formulation within the pH of 4.5-6.5, taught by Chugh et al. since they have proven it would be possible to do so.
Claim(s) 31 and 40-45 s/are rejected under 35 U.S.C. 103 as being unpatentable over DE 20219665 U1 and Frank et al., (WO 2013188979 Al) in view of McNeely et al. (McNeely et al. Intranasal Azelastine. A Review of its Efficacy in the Management of Allergic Rhinitis. Drugs 1998 Jul; 56 (1): 91-114) and Bagger et al. (Bagger et al., A microdialysis model to examine nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride as a model drug. International Journal of Pharmaceutics 269 (2004) 311–322) and further in view of Chugh et al. (Chugh et al., Intranasal drug delivery: a novel approach. Indian J Otolaryngol Head Neck Surg. (April–June 2009) 61:90–94), Sun et al. (CN 102078285 A) and Curtis-Fish et al. (US 20160120990 A1).
The teachings of DE 20219665 U1, Frank et al., McNeely et al. and Bagger et al. are described in claim 31 above that to treat obesity creating a feeling of short-term satiety by administering to the subject active ingredient(s) antiallergics/antihistamines azelastine, local anesthetics lidocaine, with excipient(s).
DE 20219665 U1, Frank et al., McNeely et al. and Bagger et al. do not teach the composition is sprayable at an1bient temperature, and wherein the composition is capable of forming a gel at a temperature greater than ambient temperature.
Sun et al. teach by using in-situ gel, it can make the formulation in the intranasal retention time is prolonged. (0009). This invention the corticosteroid hormone nasal in-situ gel is temperature sensitive type gel, under room temperature is the solution of free-flowing, nasal cavity temperature lower gel forming semisolid gel state. The temperature sensitive type hydrophilic gel material is selected from methylcellulose, (0014), sodium carboxymethyl cellulose (CMC-Na), and pectin, (0033), with the compound like azelastine, (0025) or azelastine hydrochloride. (0039), where the room temperature is 20°C, and the Embodiment 1-5, viscosity more than 250cP suitable for nasal use, while example 1-3, viscosity less than 60cP, suitable for use as nasal spray agent, (0051). Increasing temperature from room temperature 25°C to 33°C, viscosity of formulations is increased and forming gel. (0055). Nasal cavity physiological temperature at 33°C, said preparation are forming gel. (0056).
Sun et al. do not teach temperature range higher than 33°C.
Curtis-Fisk et al. teach Determination of Gelation Temperature, (0044), for example intranasal compositions (0028). Depending on the compositions, the gelation happens at temperatures higher than 33°C-56°C: (Tables 2-6, pg. 6-7)
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Also, the temperatures a composition/formulation sprayable or gelling are composition/formulation properties and they are not process properties, so temperatures that the composition/formulations sprayable and gelling are not linked with motivation to suppress appetite process.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to treat obesity causally and symptomatically in one medication by creating a feeling of satiety, by administering to respective individual active ingredient(s) antiallergics/antihistamines azelastine, local anesthetics lidocaine, with excipient(s) pectins, methylcellulose or carboxymethylcellulose, taught by DE 20219665 U1, for intranasal spray taught by Frank et al, and azelastine can be salt form azelastine hydrochloride to have its concentrations lasted up to 12 hrs to have its effect, taught by McNeely et al. and lidocaine can be salt lidocaine hydrochloride, with its concentrations lasted up to 120 mins to have its effects taught by Bagger et al., and to have the formulation sprayable at ambient temperatures and gelling at greater than ambient temperature, from 33°C, taught by Sun et al. and from 33°C-56°C, taught by Curtis-Fisk et al. since they have proven it would be possible to do so.
Claim(s) 31 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over DE 20219665 U1 and Frank et al. (WO 2013/188979 Al) in view of McNeely et al. (McNeely et al. Intranasal Azelastine. A Review of its Efficacy in the Management of Allergic Rhinitis. Drugs 1998 Jul; 56 (1): 91-114) and Bagger et al. (Bagger et al., A microdialysis model to examine nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride as a model drug. International Journal of Pharmaceutics 269 (2004) 311–322) and further in view of Liversidge et al. (US 8003127 B2), Chiragkumar (US 20140322330Al) and Fleming et al. (AU 2014315459 A1).
The teachings of DE 20219665 U1, McNeely et al. and Bagger et al. are described in claim 31 above that to treat obesity creating a feeling of short-term satiety by administering to the subject active ingredient(s) antiallergics/antihistamines azelastine, local anesthetics lidocaine, with excipient(s).
DE 20219665 U1, Frank et al. McNeely et al. and Bagger et al. do not teach the pharmaceutical composition includes: about 0.05% to about 0.3% w/w of the histamine antagonist; about 0.2% to about 2.00% w/w of the local anesthetic; and about 0.1% to about 4.0% w/w of the one or more pharmaceutically acceptable excipients.
Fleming et al. teach Intranasal Formulation For The Treatment Of Cardiopulmonary Resuscitation (CPR), Cardiac Life Support (CLS), Anaphylaxis And/or Anaphylactoid Reactions. (Abs). In some embodiments, the composition includes antihistamines (e.g., H 1 and/or H 2 receptor antagonists), (022), like azelastine, (0130); local anesthetic agents (0115) like lidocaine (0128). In one aspect, a pharmaceutical product, comprising a
pharmaceutical apparatus for intranasally administering by suitable pressurized spray devices or . suitable nasal pump spray devices (0147). 34. The composition of any one of claims 26-33, wherein the first cellulose is a crystalline cellulose. 35. The composition of claim 34, wherein the first cellulose is a microcrystalline cellulose. 36. The composition of any one of claims 25-35, wherein the carrier further comprises an excipient. 37. The composition of claim 36, wherein the excipient is about 0.5% to about 5% w/w of the weight of the composition. (pg. 135).
Fleming et al. do not teach the w/w% of antihistamine like azelastine nor local anesthetic like lidocaine.
Chiragkumar teaches aerosol or spray delivery system, to administer bioactive agents, nasally, (0065), about 0.2% w/w to about 5% w/w lidocaine in an emulsion formulation, (0066). Bioactive agents that may be incorporated into systems include antihistamines, appetite suppressants. (0123). Excipients include pectin. (129).
Chiragkumar does not teach azelastine as the antihistamines, as an appetite suppressant, in the composition.
Liversidge et al. teach a solution formulation for nasal administration comprising azelastine, comprises 0.1% w/w of azelastine of the composition. (Claim 1). Excipients included can be microcrystalline cellulose. (Col. 20, line 44). Any suitable dosage form can be used for the compositions of the invention. In another embodiment, the compositions of the invention are formulated into aerosol, nasal. (Col. 6, line 52-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to treat obesity causally and symptomatically in one medication by creating a feeling of satiety, by administering to respective individual active ingredient(s) antiallergics/antihistamines azelastine, local anesthetics lidocaine, with excipient(s) pectins, methylcellulose or carboxymethylcellulose, taught by DE 20219665 U1, for intranasal spray taught by Frank et al, and azelastine can be salt form azelastine hydrochloride to have its concentrations lasted up to 12 hrs to have its effect, taught by McNeely et al. and lidocaine can be salt lidocaine hydrochloride, with its concentrations lasted up to 120 mins to have its effects taught by Bagger et al., and to have the composition including antihistamine like azelastine and local anesthetic like lidocaine in 0.5% to about 5% w/w of excipient microcrystalline cellulose of the composition, taught by Fleming et al., to have 0.2% w/w to about 5% w/w lidocaine, taught by Chiragkumar and 0.1% w/w of azelastine of the composition, taught by Liversidge et al. since they have proven it would be suitable to do so.
Claim(s) 48, 49-53 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muni et al. (US 20130245608 A1) in view of Bagger et al. (Bagger et al., A microdialysis model to examine nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride as a model drug. International Journal of Pharmaceutics 269 (2004) 311–322), and further in view of McNeely et al. (McNeely et al. Intranasal Azelastine. A Review of its Efficacy in the Management of Allergic Rhinitis. Drugs 1998 Jul; 56 (1): 91-114), Chugh et al. (Chugh et al., Intranasal drug delivery: a novel approach. Indian J Otolaryngol Head Neck Surg. (April–June 2009) 61:90–94) and JP 2016531140 A.
Muni et al. teach methods for delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects, including methods and systems for treating paranasal sinusitis and ethmoid disease. (Abs). Methods may also be used to deliver substances to the brain or alter the functioning of the olfactory system, including the delivery substances to occlude or alter olfactory perception, to suppress appetite or otherwise treat obesity. (0182). In some applications such as those where it is desired to prevent or inhibit the effect of histamine, the substances delivered in this invention may include various antihistamines such as azelastine. (181). Lidocaine is also a type of drug that could be delivered. (0159).
Muni et al. do not teach delivery histamine antagonist/azelastine and anesthetic/lidocaine by intranasal.
Bagger et al. teach nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride for olfactory absorption.
McNeely et al. teach intranasal azelastine (title), that causes smell reduction (pg. 105, right col, 1st par.) and Azelastine nasal spray is azelastine hydrochloride. (pg. 110, right col., 3rd par.).
Chugh et al. teach small molecules and macro molecules being studied for nasal delivery, including antihistamines like azelastine and central nervous system drug like lidocaine. (pg. 92, Table 1), by intranasal delivery (pg. 90, right col., 3rd par.). This method connects the olfactory and trigeminal nerves and provide between the brain and external environments. (pg. 90, right col. 3rd par.). Increased nasal absorption of protein therapeutic agents can be achieved by using bioadhesive agents and absorption enhancers. Common bioadhesive agents are cellulose.
Muni et al., McNeely et al. do not teach excipients for intranasal delivery. Chugh et al. teach cellulose, but do not teach more what cellulose.
JP 2016531140 A teach intranasal administration of different drugs, (pg. 1, 2nd par.), including antihistamine (pg. 10, last par.), azelastine (pg. 11, 1st par.), and lidocaine (pg. 10, 2nd last par.), using mucoadhesive agent like microcrystalline cellulose, cellulose derivatives, (pg. 10, 2nd par.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to deliver drugs to subjects to alter the functioning of the olfactory system, including the delivery substances to occlude or alter olfactory perception, to suppress appetite or otherwise treat obesity, like antihistamine azelastine and lidocaine taught by Muni et al., lidocaine delivered by nasal delivery taught by Bagger et al., intranasal azelastine delivery taught by McNeely et al., nasal delivery, antihistamines azelastine and lidocaine, taught by Chugh et al. and mucoadhesive excipient microcrystalline cellulose can be used for intranasal delivery taught by JP 2016531140 A, since they have proven it would be possible to do so.
With regard to claim 53,
Chugh et al. teach small molecules and macro molecules being studied for nasal delivery, including antihistamines like azelastine and central nervous system drug like lidocaine. (pg. 92, Table 1). pH of the drug formulation is also important for absorption since nasal irritation is
minimized when products are delivered at pH 4.5–6.5. (pg. 91, right col., 2nd last par.). Also, pHs are composition/formulation properties and they are not process properties, so pHs of the composition/formulation are not linked with motivation to suppress appetite process.
With regard to claim 57,
McNeely et al. teach Azelastine nasal spray is supplied as a 1 mg/ml solution of azelastine hydrochloride in a metered dose pump spray bottle. (pg. 110, right col., 3rd par.). A nasal spray with a pump is designed to aerosolize its liquid medication creating a fine mist or spray that delivers the drug into the nasal passages, transforming the liquid into small airborne particles (aerosols) for easier inhalation and absorption.
Claims 54-58, have limitations of compositions, which are not properties of process limitations, so they are not linked to the limitations of independent claim 48 which claims a process for inducing anosmia in a subject.
Claim(s) 48 and 54-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muni et al. (US 20130245608 A1) in view of Bagger et al. (Bagger et al., A microdialysis model to examine nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride as a model drug. International Journal of Pharmaceutics 269 (2004) 311–322), and further in view of McNeely et al. (McNeely et al. Intranasal Azelastine. A Review of its Efficacy in the Management of Allergic Rhinitis. Drugs 1998 Jul; 56 (1): 91-114), Chugh et al. (Chugh et al., Intranasal drug delivery: a novel approach. Indian J Otolaryngol Head Neck Surg. (April–June 2009) 61:90–94), JP 2016531140 A., Sun et al. (CN 102078285 A) and Curtis-Fish et al. (US 20160120990 A1).
The teachings of Muni et al., Bagger et al., McNeely et al., Chugh et al. and JP 2016531140 A., are described in claim 48 above that for inducing anosmia in a human subject, comprising intranasally administering to the subject a pharmaceutical composition comprising a histamine antagonist, a local anesthetics with excipient(s).
Muni et al., Bagger et al., McNeely et al., Chugh et al. and JP 2016531140 A. do not teach the composition is sprayable at an1bient temperature, and wherein the composition is capable of forming a gel at a temperature greater than ambient temperature.
Sun et al. teach by using in-situ gel, it can make the formulation in the intranasal retention time is prolonged. (0009). This invention the corticosteroid hormone nasal in-situ gel is temperature sensitive type gel, under room temperature is the solution of free-flowing, nasal cavity temperature lower gel forming semisolid gel state. The temperature sensitive type hydrophilic gel material is selected from methylcellulose, (0014), sodium carboxymethyl cellulose (CMC-Na), and pectin, (0033), with the compound like azelastine, (0025) or azelastine hydrochloride. (0039), where the room temperature is 20°C, and the Embodiment 1-5, viscosity more than 250cP suitable for nasal use, while example 1-3, viscosity less than 60cP, suitable for use as nasal spray agent, (0051). Increasing temperature from room temperature 25°C to 33°C, viscosity of formulations is increased and forming gel. (0055). Nasal cavity physiological temperature at 33°C, said preparation are forming gel. (0056).
Sun et al. do not teach temperature range higher than 33°C.
Curtis-Fisk et al. teach Determination of Gelation Temperature, (0044), for example intranasal compositions (0028). Depending on the compositions, the gelation happens at temperatures higher than 33°C-56°C: (Tables 2-6, pg. 6-7)
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Also, the temperatures a composition/formulation sprayable or gelling are composition/formulation properties and they are not process properties, so temperatures that the composition/formulations sprayable and gelling are not linked with motivation to suppress appetite process.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to deliver drugs to subjects to alter the functioning of the olfactory system, including the delivery substances to occlude or alter olfactory perception, to suppress appetite or otherwise treat obesity, like antihistamine azelastine and lidocaine taught by Muni et al., lidocaine delivered by nasal delivery taught by Bagger et al., intranasal azelastine delivery taught by McNeely et al., nasal delivery, antihistamines azelastine and lidocaine, taught by Chugh et al. and mucoadhesive excipient microcrystalline cellulose can be used for intranasal delivery taught by JP 2016531140 A, and to have the formulation sprayable at ambient temperatures and gelling at greater than ambient temperature, from 33°C, taught by Sun et al. and from 33°C-56°C, taught by Curtis-Fisk et al. since they have proven it would be possible to do so.
Claim(s) 48 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muni et al. (US 20130245608 A1) in view of Bagger et al. (Bagger et al., A microdialysis model to examine nasal drug delivery and olfactory absorption in rats using lidocaine hydrochloride as a model drug. International Journal of Pharmaceutics 269 (2004) 311–322), and further in view of McNeely et al. (McNeely et al. Intranasal Azelastine. A Review of its Efficacy in the Management of Allergic Rhinitis. Drugs 1998 Jul; 56 (1): 91-114), Chugh et al. (Chugh et al., Intranasal drug delivery: a novel approach. Indian J Otolaryngol Head Neck Surg. (April–June 2009) 61:90–94), JP 2016531140 A., Liversidge et al. (US 8003127 B2), Chiragkumar (US 20140322330Al) and Fleming et al. (AU 2014315459 A1).
The teachings of Muni et al., Bagger et al., McNeely et al., Chugh et al. and JP 2016531140 A., are described in claim 48 above that for inducing anosmia in a human subject, comprising intranasally administering to the subject a pharmaceutical composition comprising a histamine antagonist, a local-anesthetic with excipient(s).
Muni et al., Bagger et al., McNeely et al., Chugh et al. and JP 2016531140 A. do not teach the pharmaceutical composition includes: about 0.05% to about 0.3% w/w of the histamine antagonist; about 0.2% to about 2.00% w/w of the local anesthetic; and about 0.1% to about 4.0% w/w of the one or more pharmaceutically acceptable excipients.
Fleming et al. teach Intranasal Formulation For The Treatment Of Cardiopulmonary Resuscitation (CPR), Cardiac Life Support (CLS), Anaphylaxis And/or Anaphylactoid Reactions. (Abs). In some embodiments, the composition includes antihistamines (e.g., H 1 and/or H 2 receptor antagonists), (022), like azelastine, (0130); local anesthetic agents (0115) like lidocaine (0128). In one aspect, a pharmaceutical product, comprising a
pharmaceutical apparatus for intranasally administering by suitable pressurized spray devices or . suitable nasal pump spray devices (0147). 34. The composition of any one of claims 26-33, wherein the first cellulose is a crystalline cellulose. 35. The composition of claim 34, wherein the first cellulose is a microcrystalline cellulose. 36. The composition of any one of claims 25-35, wherein the carrier further comprises an excipient. 37. The composition of claim 36, wherein the excipient is about 0.5% to about 5% w/w of the weight of the composition. (pg. 135).
Fleming et al. do not teach the w/w% of antihistamine like azelastine nor local anesthetic like lidocaine.
Chiragkumar teaches aerosol or spray delivery system, to administer bioactive agents, nasally, (0065), about 0.2% w/w to about 5% w/w lidocaine in an emulsion formulation, (0066). Bioactive agents that may be incorporated into systems include antihistamines, appetite suppressants. (0123). Excipients include pectin. (129).
Chiragkumar does not teach azelastine as the antihistamines, as an appetite suppressant, in the composition.
Liversidge et al. teach a solution formulation for nasal administration comprising azelastine, comprises 0.1% w/w of azelastine of the composition. (Claim 1). Excipients included can be microcrystalline cellulose. (Col. 20, line 44). Any suitable dosage form can be used for the compositions of the invention. In another embodiment, the compositions of the invention are formulated into aerosol, nasal. (Col. 6, line 52-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to deliver drugs to subjects to alter the functioning of the olfactory system, including the delivery substances to occlude or alter olfactory perception, to suppress appetite or otherwise treat obesity, like antihistamine azelastine and lidocaine taught by Muni et al., lidocaine delivered by nasal delivery taught by Bagger et al., intranasal azelastine delivery taught by McNeely et al., nasal delivery, antihistamines azelastine and lidocaine, taught by Chugh et al. and mucoadhesive excipient microcrystalline cellulose can be used for intranasal delivery taught by JP 2016531140 A, and to have the composition including antihistamine like azelastine and local anesthetic like lidocaine in 0.5% to about 5% w/w of excipient microcrystalline cellulose of the composition, taught by Fleming et al., to have 0.2% w/w to about 5% w/w lidocaine, taught by Chiragkumar and 0.1% w/w of azelastine of the composition, taught by Liversidge et al. since they have proven it would be suitable to do so.
Double Patenting
The nonstatutory 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 nonstatutory 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 nonstatutory 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 nonstatutory 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 31-35, 40-46, 48-52 and 54-56 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 16/614,977/US 20200179277Al (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because compositions in the application No. 16/614,977/US 20200179277Al are matching with compositions in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615