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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, Claims 28-33 in the reply filed on 3/23/26 is acknowledged. The restriction is made final.
Claim Objections
Claims 34-45 are objected to because of the following informalities: Claims 34-45 should be labeled as withdrawn or canceled.
Regarding claim 30 , delete “more” from the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubin (US 2019/0321570), hereinafter Rubin.
Regarding claim 28, Rubin teaches a method of producing inhalable products (Fig. 30, paragraphs 217-222), comprising:
heating a liquid product substrate (Fig. 30: 2213, paragraph 217, filled with a preferably liquid aerosolizable substance or formulation, paragraph 220, heat element 2212 vaporizes the medicament substance), having a first substrate volume in a vessel comprising a vessel aperture (See Fig. 30 volume of 2224 has aperture when pierced, paragraph 220 pierce to cause an opening 2224 on top of the blister package 2213), wherein the aperture is in fluid communication with a first chamber having a proximal portion and a distal portion (Fig. 30, opening 2224 is in communication with chamber 2210 which has a proximal portion nearest the opening and a distal portion at the top of the chamber), and the fluid communication is provided through an aperture in the proximal portion of the first chamber (Fig. 30 aperture at the bottom of the chamber), to produce a mixed product having both gas phase and liquid phase molecules (paragraph 221, vapor and condensation) and a second substrate volume that is greater than the first substrate volume. (Fig. 30, the volume of chamber 210 is greater than the volume of 2213)
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.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Rubin
Regarding claim 29, Rubin teaches the method of claim 28, and teaches that the digital control unit may determine the desired power and temperature to heat the heating element for proper delivery characteristics of that particular medicament. (paragraph 219)
Therefore, the heating rate or profile is a results effective variable based on the product and desired delivery characteristics.
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the method of Rubin so that wherein heating the liquid product substrate comprises heating the liquid product substrate at a first heating rate of from about 0.001 degrees C/min to 150 degrees C/min as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller. Further, based on the very large range of heating rates claimed, there is no criticality in the claimed range.
Claims 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Rubin in view of Hale et al (US 2007/0028916), hereinafter Hale.
Regarding claim 30, Rubin teaches the method of claim 28, and further teaches comprising heating the mixed product in the first chamber, the vessel, or a combination thereof (Fig. 30, paragraph 217, a heating element 2212 in close communication with the proximal end of first chamber 2210 such as to send heat to that first chamber including sending heat to an aerosolizable substance, paragraph 220, heating element is able to vaporize the medicament substance from medicament slide 2214 to produce a gaseous product, paragraph 220 produces a vapor) but is silent as to having more at least 80% gas phase molecules.
However, Hale teaches that the amount of vaporization is related to the percent yield from the drug supply article (paragraph 201) and therefore the percent yield is directly related the amount of drug substrate needed.
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Rubin so that a gaseous product of at least 80% gas phase molecules is produced in order to minimize the amount of drug substrate required.
Regarding claim 31, Rubin in view of Hale teaches the method of claim 30, and Rubin further comprising heating the gaseous product in the first chamber, the vessel or a combination thereof, to produce a heated gaseous product (Paragraph 220 heats and vaporizes the substrate, paragraph 54 uses raises to temperature to aerosolize liquid droplets to promote reduced particle size) but does not teach having a temperature at least 10% higher than the boiling point for the product substrate.
However, Hale teaches rapidly heating to a temperature sufficient to vaporize all or a portion of the drug to form a drug vapor. (Paragraph 172, supplies heat at a rate to achieve a temperature of at least 200 degrees, 240 degrees or up to 340 degrees, paragraph 178, heating the substrate produces a drug composition vapor that in the presence of the flowing gas generates aerosol particles in the desired size range)
Therefore it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the method of Rubin so that the vapor has a temperature at least 10% higher than the boiling point for the substrate as claimed in order to substantially volatize the drug composition in a short period of time (Hale, paragraph 77) and to produce the desired particle size range. (paragraph 54 of Rubin teaches using temperature to produce the desired droplet size)
Regarding claim 32, Rubin in view of Hale teaches the method of claim 30, and teaches allowing the gaseous heated product to cool to a mist (paragraph 220 vapor can cool and condense to form a condensation aerosol) but does not explicitly, wherein the heavy mist product comprises particles or droplets having an average diameter of from about 3.5 microns to about 5 microns.
However, Rubin teaches that In most instances, aerosol particles with a mass median aerodynamic diameter, MMAD, between 0.5 and 5 micrometers are ideal for lung delivery; whereas, aerosol particles with a MMAD of greater than 5 micrometers have deposition in the upper airways rather than the lungs. Aerosol particles with a MMAD of 2 to 5 micrometers have deposition in the bronchi and bronchioles, and aerosol particles with a MMAD of less than 2 micrometers have deposition in the alveoli, for deep lung and/or systemic delivery. Selection of MMAD is one method of targeting aerosols to different airway regions. (Paragraph 4, the examiner notes that the term heavy mist is defined by the particle size see paragraph 11 of the specification)
Therefore, it would have been obvious to a person of ordinary skill in the art to have modified the device of Rubin so that the average particle or droplet size has an average diameter from about 3.5 microns to about 5 microns as claimed when the desired delivery location is the lungs.
Regarding claim 33, Rubin in view of Hale teaches the method of claim 32, and Rubin further teaches wherein allowing the gaseous product or heated gaseous product to cool comprises allowing the gaseous product or heated gaseous product to pass into a second chamber in fluid communication with the first chamber, (Fig. 30, paragraph 220 passes from chamber 2210 to chamber 2225) wherein the second chamber has a lower temperature than the first chamber (paragraph 220 holding chamber 2225 where the particles can cool further), or wherein allowing the gaseous product or heated gaseous product to cool comprises allowing the gaseous product or heated gaseous product to pass into a breathing system, or wherein allowing the gaseous product or heated gaseous product to cool comprises allowing the gaseous product or heated gaseous product to pass into a subject’s oral cavity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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