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 .
Receipt is acknowledged of Amendments and Remarks filed on 07/222/26. Claims 107 and 122 have been amended, claims 108, 119 and 123-139 have been cancelled and no new claims have been added. Accordingly, claims 107, 109-118 and 120-122 are pending and under examination on the merits.
Election/Restrictions
Applicants’ election without traverse of Group I, claims 107-122 in the reply filed on 07/22/26 is acknowledged. Non-elected claims and claims 108 and 119 have been canceled. Accordingly, claims 107, 109-118 and 120-122 remain pending and under examination.
Claim Objections
Claims 113-116 are objected to because of the following informalities:
Claims 113-116 contain typographical errors. In claims 113-115, last line, the term “individula’ s” should be -individual’s-. The term “roseoil” in line 6 of claim 116 should be -rose oil-.
Claim 116 is objected to because there is no evidence that smoke oil is safe for human use. It appears that it is an industrial oil.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 107, 109-118 and 120-122 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 107, 109-118 and 121 are indefinite because in claim 107, the basis for the claimed concentration range in percentages is missing. It is not disclosed and is not clear what is the basis for percentage range of 1 to 8%. Is this percentage range based on the total weight of the composition/droplets, part of it or else? It is also not clear if the concentration range is based on the weight or volume of the base.
Claims 107, 109-118 and 121 are indefinite because in claim 107, the limitation of “the solution comprising between 1% and 8% calcium chloride and/or magnesium chloride in water” renders the scope indianite. This is so because it is not clear if the range of -between 1% and 8%- is only for calcium chloride or for magnesium chloride as well. It is also not clear when the solution comprises both calcium chloride and magnesium chloride, if the said 1% to 8% is each salt’s concentration or the combined concentration.
Claims 109-118 and 120-122 recite the limitation "the composition of claim 107”. There is insufficient antecedent basis for this limitation in the claim. Claim 107 does not provide support for composition, but rather a hypertonic solution.
Claims 111-116 recite the limitation "the salt-based composition" in the inhalation device of claim 107. There is insufficient antecedent basis for this limitation in the claim. Claim 107 does not provide support for either a salt-based or composition, but rather a hypertonic solution.
Claim 116 as written includes species of lavender or spike lavender oil, black or green pepper oil. Proper Markush language is “selected from the group consisting of A, B, C and D”. The examiner suggests rewording the claim to include the proper Markush language. Note: MPEP § 803.02.
Claim 120 recites that the composition of claim 107, wherein the hypertonic solution of the droplets comprises from about 1% to about 10% calcium chloride. This is indefinite because claim 107 recites a range of between 1% and 8%. As such, claim 120 is improperly broadening the scope of its parent claim 107.
Claim 122 recites the limitation "the hypertonic solution of the droplets further comprises from … sodium chloride" in the composition of claim 121. This is indefinite because claim 121 already recites the presence of a quantity of sodium chloride. Thus, it is not clear claim 122 is attempting to recite the concentration of the same sodium chloride in claim 121 or if this is a different sodium chloride.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
The recitation of the percent reduction in number of exhaled particles in claims 113-115 are the effect of the claimed hypertonic solution after it has been administered and does not materially affect the scope of the claimed device and hypertonic solution.
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 nonobviousness.
Applicant’s Claims
Claim 107 is directed to an inhalation device comprising: a hypertonic solution comprising between 1.0 and 8.0% calcium chloride and/or magnesium chloride in water; the device forming droplets having a mass median droplet diameter between approximately 8 microns to approximately 15 microns to predominately deliver the droplets in the upper respiratory tract.
Claims 107, 109-115, 117-118 and 120-122 are rejected under 35 U.S.C. 103 as being unpatentable over Clarke et al (US 20120058198) in view of Edwards et al (US 20050207983) or as evidenced by Dickens et al (WO 2005058400).
Clarke et al teaches a method of administering to an individual having pneumonia, a bacterial respiratory tract infection, an effective amount of a formulation comprising a therapeutically effective amount of a calcium salt, wherein the formulation is administered as an aerosol to the respiratory tract of the individual. “The term “respiratory tract” as used herein includes the upper respiratory tract (e.g., nasal passages, nasal cavity, throat, pharynx), respiratory airways (e.g., larynx, tranchea, bronchi, bronchioles) and lungs (e.g., respiratory bronchioles, alveolar ducts, alveolar sacs, alveoli) (See [0008], [0016], [0042] and [0051]).
Regarding claims 107, 111 and 120, Clarke et al teach a salt formulation intended for administration to the respiratory tract (e.g., to the mucosal surface of the respiratory tract), and can be administered in any suitable form, such as a solution, a suspension, a spray, a mist, a vapor, droplets, particles, or a dry powder form.
Preferably the salt formulation is aerosolized for administration to the respiratory tract via the oral airways using any suitable method and/or device, including a metered dose inhaler, a nebulizer, an atomizer, a continuous sprayer, an oral spray or a dry powder inhaler (DPI). Salt formulations can be aerosolized for administration via the nasal airways using a nasal pump or sprayer, a metered dose inhaler (e.g., a pressurized metered dose inhaler (pMDI) (See [0149]). Clarke et al also disclose a salt formulation preferably containing a concentration of salt (e.g., calcium salt, sodium salt) and wherein liquid formulations are nebulized in order to deliver an effective amount to the respiratory tract of a subject. The formulations are administered to the respiratory tract (e.g., by inhalation of aerosolized formulation, such as nebulized liquid or aerosolized dry powder) or to nasal cavity (See [0062]).
Clarke et al further teach that a liquid salt formulation (e.g., a calcium salt formulation) can contain between 0.1% to about 10% salt (w/v). Liquid formulations can contain about 0.001M to about 1.5M salt (See [0062]). For salt formulations in the form of solutions, any suitable carrier or excipient can be included. Examples of excipients include water, ethanol, preservatives, etc, (See [0061]).
Regarding the mass median diameter, Clarke et al teach that for administration, a suitable method (e.g., nebulization, dry powder inhaler) is selected to produce aerosols with the appropriate particle size for preferential delivery to the desired region of the respiratory tract, such as the upper airway (generally particles of about 3 microns or larger diameter) (See [0151]).
Regarding claims 107 and 117-118, Clarke et al teach that a hypertonic solution may have 2×, 3×, 4×, 5×, or 10× tonicity (See [0052]).
Regarding claims 107 and 121-122, Clarke et al teach that the said aqueous liquid salt formulations can vary in tonicity and in the concentrations of calcium salt and sodium salt that are present in the formulation. For example, the salt formulation can contain 0.212 M CaCl2 and 0.027 M NaCl (2.35% CaCl2, 0.027% NaCl) and be hypertonic, 0.424 M CaCl2 and 0.054 M NaCl (4.70% CaCl2, 0.054% NaCl) and be hypertonic (See [0075]). Some salt formulations contain a calcium salt and a sodium salt, for example 0.12 M calcium chloride in 0.15 M sodium chloride, or 1.3% (w/v) calcium chloride in 0.90% saline (See [0066]-[0068]).
Regarding claims 107 and 112, Clarke et al teach that the said salt formulations (e.g., calcium salt formulations) contain at least one salt as an active ingredient and can optionally contain additional salts or agents. The said optional salt can include any salt form of the elements sodium, magnesium, etc. Magnesium salt may be magnesium chloride (See [0055], [0056] and [0059]).
Clarke et al teach that the said salt formulations are intended for administration to the respiratory tract (e.g., to the mucosal surface of the respiratory tract), and can be administered in any suitable form, such as a solution, a suspension, a spray, a mist, droplets, particles, etc. The said salt formulations can be aerosolized for administration via the nasal airways using a nasal pump or sprayer (See [0149]).
Clarke et al disclose that the preferred particle size (i.e. droplet size) for administration of the said liquid formulations to upper respiratory system is 3 microns or larger but does not elaborate on that. This is, however, well known in the art as taught by Edwards et al and as evidenced by Dickens et al.
Edwards et al teach formulations for decreasing particle exhalation. Formulations for pulmonary administration include a material that significantly alters physical properties such as surface tension and surface elasticity of lung mucus lining fluid, which may be isotonic saline, a hypertonic saline solution or other solution containing osmotically active materials (See abstract and [0021]).
Regarding claim 107, Edwards et al teach formulation comprising an aqueous solution delivered as an aerosol with particles having a diameter between about 1 and about 10 microns. The aerosol can consist just of a solution, such as an aqueous solution, most preferably a saline solution. Concentration ranges of the salt or other osmotically active material range from about 0.9% to about 10% (See [0035] and claim 13).
Edwards et al disclose that the formulations are typically administered to an individual to deliver an effective amount to alter physical properties such as surface tension and viscosity of endogenous fluid in the upper airways, thereby enhancing delivery to the lungs and/or suppressing coughing and/or improving clearance from the lungs (See [0053]).
As Evidenced:
Dickens et al disclose nasal drug delivery and teach that the smaller particles are more likely to stay in the airstreams, and less likely to deposit in the nasal cavity, they may be carried through to the throat or lungs. It has been found generally that the particles preferably have an aerodynamic diameter from about 10 μm to about 20 μm. For deposition in the turbinate and surrounding regions, the particles preferably have an aerodynamic diameter from about 10 μm to about 20 μm. For olfactory deposition, the size range is preferably about 7.5 μm to about 20 μm, and more preferably from about 10 μm to about 15 μm (See Page 4, 1st para).
Clarke et al do not anticipate the claimed formulation because they do not exemplify an aerosol droplet formulation comprising calcium chloride or magnesium chloride with a droplet size between approximately 8 to 15 microns. However, they provide adequate teaching to one of ordinary skill in the art to make and use the formulation as claimed.
Additionally, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Clarke et al with that of Edwards et al to arrive at the instant invention. It would have been obvious to do so because Clarke et al teach aerosolized formulations comprising calcium chloride, water, ethanol and preservatives to upper respiratory tract including nasal passages of a subject for treating bacterial infection of the respiratory system. Clarke et al teach that the formulation may be in a solution form and the droplets can have a diameter of greater than 3 microns. Additionally, Edawards et al teach formulations that can reduce particle exhalation form one’s respiratory stem by administering via inhalation a solution formulation that can be hypertonic and have particle diameters of up to 30 microns and preferably up to 10 microns. Also, as evidenced by Dickens et al, one of ordinary skill in the art is well advised of what particle/droplet size would deposit in the desired area of the respiratory system. As such it would have been obvious to one of ordinary skill in the art to have selected the suitable droplet size from the teachings of Clarke et al and as evidenced by Dickens et al with a reasonable expectation of success.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Regarding claims 113-115, it is noted that the claims are directed to a composition which is taught by the reference. How the composition is administered, the target site and how it behaves after delivery are not limitations of the claimed composition. Furthermore, when the reference teaches the same composition, it would be expected to have the same property and provide the same results as claimed.
Claim 116 is rejected under 35 U.S.C. 103 as being unpatentable over Clarke et al (US 20120058198) in view of Edwards et al (US 20050207983) or as evidenced by Dickens et al (WO 2005058400), as applied to claim 107 above, and in further view of Clarot et al (US 20170100446).
Clarke et al, Edwards et al and Dickens et al’s teachings are delineated above and incorporated herein. Clarke et al teach an aerosol composition comprising calcium salt and excipients. However, Clarke et al lack a specific discourse on the addition of an essential oil or extract. This is known in the art as taught by Clarot et al.
Clarot et al teach pharmaceutical compositions and methods of use thereof and in particular to nasal compositions comprising plant extracts and methods for reducing duration of a common cold in a human in need of treatment (See [0002]).
The said compositions comprise various oils as inhalants including Japanese peppermint oil, known to contain substantial amounts of menthol; orange oil, clove oil, eucalyptol, cinnamaldehyde, citral, eugenol, limonene, geraniol, citronellal, linalool, thymol, and mixtures thereof (See [0071]-[0073]). The compositions may also comprise a fragrance such as vanillin and cinnamate (See [0077]).
The said nasal compositions having physical form amendable to application to the nasal passages and/or mucosa of a human in need of treatment. These forms include liquid, generally aqueous-based nasal sprays that can be aerosolized through a non-aerosol sprayer, or through a pressurized aerosol system (See [0100]-[0101]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Clarot et al with that of Clarke et al and Edwards et al as evidenced by Dickens et al to arrive at the instant invention. It would have been obvious to do so because Clarke et al teach aerosolized formulations comprising calcium chloride and preservatives to upper airways including nasal passages of a subject in need thereof. As such it would have been obvious to one of ordinary skill in the art to have looked in the art for suitable preservatives and flavoring agents such as essential oils and extracts as taught by Clarot et al. It is thus well known to add essential oils and fragrances to respiratory formulations including nasal formulations for their various benefits.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 107, 109-118 and 120-122 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached on M-F, 7-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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