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 .
Status of Claims
The present Office action is responsive to the preliminary amendment filed on 09-08-2023. As directed, claims 1-15 and 17-23 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-23 are currently pending examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Inclusion of the phrase “takes the form of one or several lateral spaces surrounding the aerosol chamber” in the specification, or else the limitation be eliminated from the claims.
Inclusion of the term “substantially” relative to the lack of pressure increase in the subject matter presented in claim 2 in the specification, or else the limitation be eliminated from the claims.
Claim Objections
Claims 1-23 are objected to because of the following informalities:
At claim 1, line 1, it is suggested that “A” be added before “device” for clarity.
At claim 1, line 2, it is suggested that “the” before “storage” be eliminated as the limitation has not been introduced.
At claim 1, line 2, it is suggested that “compositions” be replaced with “composition” for proper grammar.
At claim 1, line 6, it is suggested that “of” be added following “downstream” for clarity.
At claim 1, line 9, it is suggested that “of” be added following “upstream” for clarity.
At claim 1, line 9, it is suggested that “of” be added following “downstream” for clarity.
At claim 1, lines 11-12, it is suggested that “in the continuity from one another” be replaced with “in continuity with one another” for clarity.
At claim 1, lines 13-14, it is suggested that “takes the form of” be replaced with “takes a form of” as the limitation has not been previously introduced.
At claim 1, lines 14-15, it is suggested that “the corresponding lateral walls” be replaced with “corresponding lateral walls” as the limitation has not been introduced.
At claim 1, line 15, it is suggested that “to” be added following “equal” for clarity.
At claim 2, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 2, line 1, it is suggested that “wherein” be added before “said heating device” for clarity.
At claim 2, line 1, it is suggested that “said heating device” be replaced with “said one or more heating device” for consistency with claim 1.
At claim 3, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 3, line 1, it is suggested that “wherein” be added before “said volatilizing element” for clarity.
At claim 3, line 3, it is suggested that “a” be added before “pore size” for clarity.
At claim 4, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 4, lines 1-2, it is suggested that “wherein said volatilizing element denotes or comprises one or more vibrating mesh adapted to” be replaced with “wherein said at least one vibrating mesh is adapted to” given that claim 4 depends from claim 3 which already introduces “at least one vibrating mesh”.
At claim 5, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 5, line 3, it is suggested that “adapted to present an increase contact surface be replaced with “adapted to increase a contact surface” for clarity.
At claim 5, line 4, it is suggested that a comma be added before “and/or” for clarity.
At claim 6, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 6, line 1, it is suggested that “at least one” be added before “preheating chamber” for consistency with claim 1.
At claim 6, line 2, it is suggested that “driving” be replaced with “configured to drive” to avoid recitation of positive method steps in an apparatus claim.
At claim 7, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 7, line 1, it is suggested that “wherein” be added before “said aerosol chamber” for clarity.
At claim 7, line 2, it is suggested that the comma following “chamber” be eliminated for clarity.
At claim 8, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 9, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 10, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 10, line 1, it is suggested that “further” be added before “comprising” for clarity.
At claim 10, line 1, it is suggested that “more than one” be replaced with “several” for consistency with claim 9.
At claim 10, line 2, it is suggested that “facing each other” be replaced with “configured to face each other” for clarity.
At claim 11, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 11, line 1, it is suggested that “at least one” be added before “internal wall” for consistency with claim 10.
At claim 11, line 3, it is suggested that “acting” be replaced with “configured to act” to avoid positive recitation of method steps in an apparatus claim.
At claim 12, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 12, line 1, it is suggested that a comma be added following “claim 10” for clarity.
At claim 12, line 1, it is suggested that “further” be added before “comprising” for clarity.
At claim 13, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 13, line 3, it is suggested that a comma be added following “a capillary assembly”.
At claim 14, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 14, line 2, it is suggested that “the temperature” be replaced with “a temperature” as the limitation has not been introduced.
At claim 14, lines 2 and 5, it is suggested that “at least one” be added before “preheating” for consistency with claim 1.
At claim 14, line 3, it is suggested that “the frequency and amplitude” be replaced with “a frequency and an amplitude” as neither term has been introduced.
At claim 14 lines 4 and 6, it is suggested that “when denoting one or more vibrating meshes” be eliminated, and instead the phrase “wherein the volatilizing element comprises one or more vibrating meshes” be added before the “further comprising” language at line 1.
At claim 14, line 4, it is suggested that “the combination” be replaced with “a combination” as the limitation has not been introduced.
At claim 14, line 5, it is suggested that “the” be added before “amplitude” for clarity.
At claim 15, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 15, line 1, it is suggested that “wherein” be added before “said volatilizing element” for clarity.
At claim 15, line 2, it is suggested that “comprising” be replaced with “comprises” for clarity.
At claim 16, line 1, it is suggested that “The” be added before “device” for clarity.
At claim 16, line 2, it is suggested that “the frequency” be replaced with “a frequency” as the limitation has not yet been introduced.
At claim 17, line 1, it is suggested that “A” be added before “method” for clarity.
At claim 18, line 1, it is suggested that “The” be added before “method” for clarity.
At claim 18, lines 1-2, it is suggested that “the modulating step” be replaced with “a modulating step” as the step has not been previously introduced.
At claim 18, line 2, it is suggested that “the temperature” be replaced with “a temperature” as the limitation has not been introduced.
At claim 18, line 2, it is suggested that “at least one” be added before “preheating” for consistency in the claimed language.
At claim 18, line 3, it is suggested that “an” be added before “amplitude” for clarity.
At claim 18, line 3, it is suggested that “the” be added before “phase difference” for clarity.
At claim 19, line 1, it is suggested that “The” be added before “method” for clarity.
At claim 20, line 1, it is suggested that “The” be added before “method” for clarity.
At claim 20, line 1, it is suggested that “the ratio” be replaced with “a ratio” as the limitation has not been introduced.
At claim 20, line 3, it is suggested that “liquid” be added before “composition” for consistency in the claims.
At claim 21, line 1, it is suggested that “The” be added before “method” for clarity.
At claim 21, line 1, it is suggested that “the ratio” be replaced with “a ratio” as the limitation has not been introduced.
At claim 22, line 1, it is suggested that “The” be added before “method” for clarity.
At claim 23, line 1, it is suggested that “The” be added before “method” for clarity.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A/the “volatilizing element” in claim 1, which is interpreted relative to the instant specification at paragraphs 28 and 45 to include at least one mesh, and/or a vibrating mesh.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-23 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.
Regarding claim 1, lines 13-15 set forth an alternative limitation and arrangement for the preheating chamber and the aerosol chamber, claiming “or wherein the preheating chamber takes the form of one or several lateral spaces surrounding the aerosol chamber having said volatizing element arranged on the corresponding lateral walls” which renders the claim indefinite. This is because it is unclear how the preheating chamber can be both upstream of the volatilizing element (as claimed in lines 7-9) while the volatilizing element is itself arranged on lateral walls of the preheating chamber. The placement of the volatilizing element on lateral walls of the preheating chamber seems to preclude the structural relationship between the two elements invoked by the term “upstream” which elicits a meaning that the two components are arranged in a sequential manner, either directly or indirectly, and in the art of inhaler devices, the direction invoked by upstream/downstream typically coincides with an airflow direction/particle direction through the device.
Attempting to read the claimed language in light of the specification does not clarify that which is currently construed. This alternate limitation is illustrated throughout Figures 4A-5B, and the only mention in the corresponding paragraphs of the instant specification that detail an upstream/downstream arrangement of any of the elements of these figures merely state “the preheating chamber 12 is still upstream the aerosol chamber 13” which does not clarify the upstream position of the volatilizing element with respect to the preheating chamber which appear to be, and seem to be claimed as, coextensive in some manner, given that volatilizing element 120A and 120B are shown within preheating chamber 12 (see for example Fig. 4A).
Applicant is encouraged to provide rebuttal evidence as to how the combination of elements in lines 1-10 and 13-15 are at once supported and possible, and if that is not possible, Applicant is encouraged to eliminate the alternative language of lines 13-15 to overcome the rejection. At present, because it is unclear how the combination of claim elements can exist within the same embodiment, both in terms of what is claimed and what is described and illustrated in the instant specification, examination of the alternative limitation of claim 1 and claims 9-12 are precluded, as an interpretation of record that at once reconciles that which is claimed and that which is disclosed cannot be determined.
For the purposes of examination, the claim will be interpreted to require the alternate arrangement of lines 10-13. The closest identified art of record relative to the claimed limitations and the second alternative presented at lines 13-15, as well as the disclosed embodiment of Figures 4A-5B will be cited hereinbelow for Applicant’s benefit.
Claims 2-23 are rejected by virtue of their dependence on claim 1.
Regarding claim 9, lines 1-4 recite “wherein said at least one preheating chamber takes the form of one or several lateral spaces surrounding said aerosol chamber, wherein said volatizing element comprises one or several vibrating meshes arranged on the corresponding lateral walls” which renders the claim indefinite. Claim 1, from which claim 9 depends, sets forth an alternative choice between a) a continuous relationship between the preheating chamber and the aerosol chamber with the volatilizing element located transversely therebetween or b) wherein the preheating chamber is formed as one or several lateral spaces surrounding the aerosol chamber with the volatilizing element arranged on corresponding lateral walls. Claim 9 is rendered indefinite because, given its broadest reasonable interpretation, claim 9 may limit the choice between the two options in claim 1 to specifically require option b, or alternatively, claim 9 includes the possibility of both options a and b structurally occurring at once (which is not supported by the instant specification) which renders the claim indefinite because it is not clear how both sets of limitations can occur in one simultaneous structure.
It is suggested that the two alternative options presented in claim 1 be presented in two separate independent claims with appropriate dependencies following thereafter each respective claim, or that option a be eliminated from claim 1 such that claims 9-12 are definite, or claims 9-12 be cancelled to overcome the rejection.
Claims 10-12 are rejected by virtue of their dependency on claim 9.
Regarding claim 12, lines 1-4 recite “comprising several preheating chambers surrounding said aerosol chamber corresponds to the interstitial space between said preheating chambers or between said preheating chambers and the housing or both” which renders the claim indefinite.
First, “the interstitial space between said preheating chambers” has not previously been introduced, and thus lacks antecedent basis. Second, it is unclear how “several preheating chambers” can themselves correspond to “the interstitial space between said preheating chambers”, as the chambers themselves cannot, at once, be both the preheating chambers and the interstitial space therebetween, or else there would not be space between respective heating chambers.
Applicant is encouraged to clarify the limitation via amendment, or cancel the claim to overcome the rejection.
Regarding claim 16, the phrase “can be” at line 1 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
To overcome the rejection, it is suggested that “can be” be replaced with “is configured to be”. The claim will be interpreted in accordance with this suggestion for the purposes of examination.
Claims 17-23 are rejected by virtue of their dependence on claim 16.
Regarding claim 17, line 2 recites “having a diameter lower than 4 micrometers” and lines 6-7 recite “having an average diameter lower than around 4 micrometers”, where both limitations refer to microdroplets of a liquid following volatilization. These contrasting limitations render the claim indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “having an average diameter lower than around 4 micrometers” which allows for microdroplets with a diameter above 4 micrometers, and the claim also recites “having a diameter lower than 4 micrometers” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In order to overcome the rejection, Applicant is encouraged to choose one of the two iterations within the claim. For the purposes of examination, as long as one recitation is found in the prior art, the claimed limitations will be deemed to be met.
Claims 18-23 are rejected by virtue of their dependence on claim 17.
Regarding claim 18, lines 3-4 recite “of the vibrating mesh and/or the number of vibrating actuators when applicable” which renders the claim indefinite. First, claim 18 depends from claim 16, which depends, in turn, on claims 1 and 15. Claim 15 introduces “more than one vibrating mesh”, and thus it is unclear which vibrating mesh of the “more than one” is identified as “the vibrating mesh” at claim 18, line 3. Further, “the number of vibrating actuators” renders the claim further indefinite because a) it is unclear of the “vibrating actuators” refer to vibrating meshes, and b) since claim 18 has identified one single vibrating mesh, it is unclear how there are multiple vibrating meshes that can be actuated. Still further, “the number” lacks antecedent basis in the claims, and the term “when applicable” is also indefinite as it is a relative term not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In order to overcome the rejection, it is suggested that “the vibrating mesh” be replaced with “the more than one vibrating mesh”, it is suggested that “the number” be replaced with “a number”, it is suggested that “vibrating actuators” be replaced with “vibrating meshes”, and it is suggested that “when applicable” be eliminated from the claim.
Regarding claim 23, the term “the substance” renders the claim indefinite. This is because in the dependency chain involving claim 23, “the substance” lacks antecedent basis. Further, it is unclear if the substance refers to the liquid composition, or if the “substance” of claim 19 is being erroneously referred to in the present dependency chain.
In order to overcome the rejection, it is suggested that claim 23 be amended to depend from claim 19. The claim will be interpreted in accordance with this suggestion for the purposes of examination.
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.
Claims 1, 6-7, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329).
Regarding claim 1, Dittmann discloses a device (“aerosol-generating device”) (paragraph 91, lines 1-2; Fig. 2) comprising a housing (101) having a storage compartment (201) adapted for the storage of a liquid composition (“liquid aerosol-forming substrate”) (paragraph 92, lines 1-4; paragraph 93, lines 1-7; Fig. 2), a volatilizing element (300) adapted to volatilize the liquid composition (“liquid aerosol-forming substrate”) into microdroplets (paragraph 95, lines 1-3; Fig. 2), and an aerosol chamber (125) (paragraph 94, lines 11-14; Fig. 2),
wherein the device (“aerosol-generating device”) further comprises at least one pre-heating chamber (204) downstream of said storage compartment (201) and in fluid communication with said storage compartment (201) by means of at least one solution inlet (paragraph 104, lines 1-12; Fig. 3, note heater 205 wrapping the capillary body 204), said at least one pre-heating chamber (204) comprising one or more heating device (205) and being arranged upstream said volatilizing element (300) (paragraph 104, lines 1-12; Fig. 3), in that said aerosol chamber (125) is downstream the volatilizing element (300) (paragraph 109, lines 1-15; Figs. 2-3), said aerosol chamber (125) comprising, or being connected to, a mouth port (124) (paragraph 106, lines 1-3; Fig. 2), wherein the preheating chamber (204) and the aerosol chamber (125) are arranged in the continuity from one another having said volatilizing element (300) along a transversal position therebetween (see Figs. 2-3, and note that chamber 204 is upstream of the atomizing element 300 and connected thereto in Fig. 3, and where 300 is upstream of chamber 125 in Fig. 2, and both figures shown the transverse extension of element 300; paragraph 109, lines 1-15).
While Dittmann notes the use of vibrating mesh to create droplets of a desired size (paragraph 23, lines 1-6 and paragraph 42, lines 1-6), Dittmann fails to explicitly disclose operation of the device that results in said microdroplets having a mean diameter equal or lower than 4 micrometers.
However, Danek teaches an electronic device (100) for producing an aerosol via inhalation (paragraph 154, lines 1-5; Fig. 1) and use of a vibrating mesh to adjust a mass median aerodynamic diameter (MMAD) (paragraph 133, lines 13-15), and further indicates that particles with an MMAD of 1-5 microns advantageously deposit in the small airways and alveoli (paragraph 146, lines 6-10).
Danek’s range of 1-5 microns for the MMAD overlaps with the claimed range of 4 micrometers or lower. In the case where the range disclosed or taught by the prior art overlaps the claimed range, a prima facie case of obviousness exists (MPEP 2144.05 I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Dittmann to include the capability and settings for producing a MMAD of between 1 and 5 microns (which overlaps the claimed range), as taught by Danek, in order to target microdroplet delivery after inhalation into the small airways and alveoli.
Regarding claim 6, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Dittmann further discloses wherein said pre-heating chamber (204) comprises one or several capillaries driving the liquid composition in contact to said volatilizing element (300) (paragraph 109, lines 1-15; Fig. 3).
Regarding claim 7, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Dittmann further discloses wherein said aerosol chamber (125), further comprising, or being connected to, an air inlet (122) adapted to combine the microdroplets with external air under inhalation via the mouth port (124) (paragraph 94, lines 5-14; paragraph 106, lines 1-2; Fig. 2).
Regarding claim 13, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Dittmann further discloses a means for collecting residues including one or several of a porous material (303), a capillary assembly (204), and a vibrating mesh (301+302+303) (porous material: paragraph 97, lines 1-5; capillary: paragraph 105, lines 1-8; vibrating mesh: paragraph 10, lines 1-8; paragraph 11, lines 1-9; paragraph 97, lines 1-6 for passages within 301; paragraph 100, lines 1-10; note that because each structure is present, it is understood to be capable of collecting residues as the claim only requires one or several of the list to achieve the function).
Regarding claim 14, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
In the relied upon embodiment, Dittmann fails to disclose a command input adapted for modulating the temperature of the pre-heating chamber.
However, in a separate embodiment, Dittmann teaches a command input (“button”) adapted for modulating the temperature of the device (paragraph 115, lines 1-2; Fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of Dittmann’s first embodiment with a command input adapted for modulating the temperature of the preheating chamber via its heater, as taught by Dittmann’s second embodiment, in order to enable a user to modulate the temperature of the heater in the preheating chamber via pressing of a button.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329), as applied to claim 1 above, in further view of Courbat (US 2017/0280771).
Regarding claim 2, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Modified Dittmann fails to disclose said heating device being adapted to heat the liquid composition at a temperature lower than its boiling point so that it provides no increase, or substantially no increase of pressure.
However, Courbat teaches an aerosolized smoking device (paragraph 98, lines 1-2; Fig. 1), wherein the control system of the device is operable to heat a liquid aerosol-forming substrate via a heater at a temperature lower than its boiling point so that it provides no increase, or substantially no increase of pressure (paragraph 27, lines 1-6 and 15-18; note that because the device is operable to heat the liquid below its boiling point, the functional limitations regarding the pressure increase, which are resultant from the heating temperature as claimed, are deemed to be met).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and device of modified Dittmann to include the capability of controlling the heating device to heat the liquid composition at a temperature lower than its boiling point so that it provides no increase, or substantially no increase of pressure, as taught by Courbat, so that the liquid does not burn during heating thereof.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329), as applied to claim 1 above, in further view of Rubsamen (US 5,724,957).
Regarding claim 3, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Dittmann further discloses wherein said volatilizing element (300) comprises at least one vibrating mesh (see 301+302 and passageways 303 forming the mesh) comprising one or several flat porous membranes (paragraph 10, lines 1-8; paragraph 11, lines 1-9; paragraph 97, lines 1-6 for passages within 301; paragraph 100, lines 1-10; Fig. 3), combined with at least one piezoelectric actuator (302) (paragraph 99, lines 1-6; Fig. 3).
Dittmann fails to disclose the mesh having pore size of around 1 pm or lower.
However, Rubsamen teaches aerosolizing a drug via a mesh membrane wherein the pore size is between 0.25 to 2.5 microns to create droplets with a diameter between 0.5-5 microns (Col. 12, lines 47-51).
Rubsamen’s range of 0.25-2.5 microns for the pore size overlaps with the claimed range of 1 micrometer or lower. In the case where the range disclosed or taught by the prior art overlaps the claimed range, a prima facie case of obviousness exists (MPEP 2144.05 I).
Given that in the modified Dittman device, the MMAD is between 1 and 5 microns, it would have been obvious to one of ordinary skill in the art to have selected a pore size of 1 micron or lower from the range of 0.25-2.5 microns outlined by Rubsamen, in order to achieve the desired droplet size of the modified Dittman device.
Regarding claim 4, Dittmann in view of Danek and Rubsamen disclose the device according to claim 3, as discussed above.
Dittmann further discloses wherein said volatilizing element (300) denotes or comprises one or more vibrating mesh (see 301+302 and passageways 303 forming the mesh) adapted to vibrate at frequencies comprised between around 500KHz and around 1500 KHz (paragraph 42, lines 1-4, see the range of 100-500 kHz which overlaps with 500 kHz, and thus anticipates the range, see MPEP 2131.03 I-II).
Claims 5 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329), as applied to claim 1 above, in further view of Hejazi (US 2021/0084970).
Regarding claim 5, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Dittmann further discloses wherein said volatilizing element (300) comprises at least one vibrating mesh (see 301+302 and passageways 303 forming the mesh) (paragraph 10, lines 1-8; paragraph 11, lines 1-9; paragraph 97, lines 1-6 for passages within 301; paragraph 100, lines 1-10; Fig. 3).
Dittmann, either alone or as modified, fails to disclose wherein the one or more vibrating mesh include a non-flat porous material adapted to present an increase contact surface with said liquid composition and/or a multilayer porous material.
However, Hejazi teaches a device (100) for aerosol delivery (paragraph 41, lines 1-4; Fig. 1), with a volatilization assembly (215) including a mesh plate (219) (paragraph 68, lines 1-4; Fig. 3), wherein the mesh plate (219) may include a non-flat porous material adapted to present an increase contact surface with said liquid composition (paragraph 71, lines 10-17; Figs. 4C-D; note that because the device includes the curved/domed, i.e. non-flat, porous membrane, the functional limitations regarding the liquid composition and surface/contact area are deemed to be met).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vibrating mesh of the modified Dittmann device to include a non-flat porous material adapted to present an increase contact surface with said liquid composition, as taught by Hejazi, as a known configuration of a mesh membrane that is an alternative to a flat membrane (paragraph 69, lines 18-22 of Hejazi).
Regarding claim 15, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Dittman as modified fails to disclose wherein said volatilizing element comprises more than one vibrating mesh, wherein at least some of adjacent vibrating meshes vibrate with a controlled phase difference.
However, Hejazi teaches a device (400) for aerosol delivery (paragraph 78, lines 1-8; Fig. 6A), with a volatilization assembly (415A-B) including more than one vibrating mesh (219) (paragraph 79, lines 1-8; Fig. 6A), and wherein the adjacent vibrating meshes vibrate with a controlled phase difference (paragraph 79, lines 16-22; paragraph 80, lines 8-12, see different frequencies and different times).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of modified Dittmann to include additional vibrating meshes capable of vibrating with controlled phase differences, as taught by Hejazi, in order to provide increased surface area for aerosolization of the liquid substrate.
Regarding claim 16, Dittmann in view of Danek and Hejazi disclose the device according to claim 15, as discussed above.
Modified Dittmann further discloses wherein said phase difference can be adjusted with respect to the frequency of vibration (Hejazi: paragraph 79, lines 16-22; paragraph 80, lines 8-12, see different frequencies and different times).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329), as applied to claim 1 above, in further view of Paprocki (US 2016/0255879).
Regarding claim 8, Dittmann in view of Danek disclose the device according to claim 1, as discussed above.
Modified Dittman fails to disclose wherein the aerosol chamber further comprises at least one aerosol heater
However, Paprocki teaches a smoking apparatus (1) (paragraph 51, lines 1-3; Fig. 1) that includes an aerosol heater (20’) disposed immediately adjacent a mouth port (3) with a lower heat capacity than other heating elements (additional heaters 20/20’ disposed throughout Fig. 3) so that it heats more quickly and to more quickly volatilize smokable material near the mouth port (3) to allow a user to inhale more quickly (paragraph 57, lines 5-12; Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of modified Dittman to include an additional heater with a low heat capacity at the aerosol chamber immediately adjacent the mouth port, as taught by Paprocki, in order to facilitate heating of the heater and the substrate more quickly, such that the volatilized material could more quickly be inhaled by the user.
Claims 17-19 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329) and Hejazi (US 2021/0084970), as applied to claim 16 above, in further view of Courbat (US 2017/0280771).
Regarding claim 17, it is noted that Dittman in view of Danek and Hejazi disclose the device according to claim 16, as discussed above.
Further regarding claim 17, Dittmann further discloses a method of volatilizing a liquid composition into microdroplets (paragraph 10, lines 1-8; paragraph 11, lines 1-9; paragraph 109, lines 1-15), by means of a device according to claim 16 (see rejection of claim 16 above, employing Dittmann, Danek, and Hejazi for the device; further note paragraph 109, lines 1-15 of Dittmann for the method of using the analogous device), the liquid composition having a viscosity higher than 2 cP at 20° C (paragraph 55, lines 1-11, and note that MPEP 2131.03 I-II for anticipation of overlapping ranges/anticipation of ranges when a prior art example is within the claimed range, where several values in the Dittmann ranges are greater than 2 cP), the method comprising a heating step a) of pre-heating said liquid composition (paragraph 105, lines 1-8; Fig. 3), and a spreading step b) of volatilizing the pre-heated liquid composition into microdroplets having an average diameter (paragraph 109, lines 1-15; paragraph 42, lines 1-6).
Presently, Dittman fails to disclose wherein the microdroplets have a diameter/an average diameter lower than 4 micrometers, and wherein the heating step occurs at a temperature lower that its boiling point, so that no vapor is produced.
However, Danek teaches an electronic device (100) for producing an aerosol via inhalation (paragraph 154, lines 1-5; Fig. 1) and use of a vibrating mesh to adjust a mass median aerodynamic diameter (MMAD) (paragraph 133, lines 13-15), and further indicates that particles with an MMAD of 1-5 microns advantageously deposit in the small airways and alveoli (paragraph 146, lines 6-10).
Danek’s range of 1-5 microns for the MMAD overlaps with the claimed range of 4 micrometers or lower. In the case where the range disclosed or taught by the prior art overlaps the claimed range, a prima facie case of obviousness exists (MPEP 2144.05 I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of Dittmann to include the capability and settings for producing a MMAD of between 1 and 5 microns (which overlaps the claimed range), as taught by Danek, in order to target microdroplet delivery after inhalation into the small airways and alveoli.
Presently modified Dittman fails to disclose wherein the heating step occurs at a temperature lower that its boiling point, so that no vapor is produced.
However, Courbat teaches an aerosolized smoking device (paragraph 98, lines 1-2; Fig. 1), wherein the control system of the device is operable to heat a liquid aerosol-forming substrate via a heater at a temperature lower than its boiling point so that no vapor is produced (paragraph 27, lines 1-6 and 15-18; note that because the device is operable to heat the liquid below its boiling point, the functional limitations regarding the lack of vapor, which are resultant from the heating temperature as claimed, are deemed to be met).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system and device of modified Dittmann to include the capability of controlling the heating device to heat the liquid composition at a temperature lower than its boiling point so that no vapor is produced, as taught by Courbat, so that the liquid does not burn during heating thereof.
Regarding claim 18, Dittmann in view of Danek, Hejazi, and Courbat disclose the method according to claim 17, as discussed above.
In the relied upon embodiment, Dittmann fails to disclose the modulation step c) of modulating the temperature of the pre-heating chamber and/or one or more of the frequency, amplitude and phase difference of vibration of the vibrating mesh and/or the number of vibrating actuators when applicable.
However, in a separate embodiment, Dittmann teaches a modulation step c) of modulating the temperature of the device via a button acted on by a user, such that the heater is controlled by activation of the button (paragraph 115, lines 1-2; Fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of Dittmann’s first embodiment with a button adapted for modulating the temperature of the preheating chamber via its heater, as taught by Dittmann’s second embodiment, in order to enable a user to achieve the modulation step of modulating the temperature of the heater in the preheating chamber via pressing of a button.
Regarding claim 19, Dittmann in view of Danek, Hejazi, and Courbat disclose the method according to claim 17, as discussed above.
Dittmann further discloses said liquid composition having viscosity higher than 2 cP at 20° C., and including between 1 and 10% of a substance having a biological effect under inhaling conditions (paragraph 55, lines 1-11, see 2-10% nicotine and the viscosity ranges, and note MPEP 2131.03 I-II as above for overlapping ranges/examples within the claimed range).
Presently modified Dittmann fails to disclose wherein said liquid composition comprises more than 60% of water, and between 5 to 40% of a polyol, said liquid composition being substantially free of additional organic solvent.
However, Hejazi further teaches an aerosol precursor which includes a water-based liquid comprised of 80% or more water (paragraph 53, lines 3-6, note that the range of 80%+ lies within the claimed range of more than 60% water, and per MPEP 2131.03 I-II, the range is anticipated), 1% of a substance having a biological effect under inhaling conditions (paragraph 53, lines 19-20, see 1% nicotine, and note that 1% lies within the claimed range, and per MPEP 2131.03 I-II, the range is anticipated), and up to 10% of propylene glycol (paragraph 53, lines 9-14, where propylene glycol is a polyol, note that up to 10% overlaps the claimed range with sufficient specificity, and per MPEP 2131.03 I-II, the range is anticipated), said liquid composition being substantially free of additional organic solvent (note paragraph 53, lines 3-27, where the only additional possible additives are cyclodextrin, which is not an organic solvent, and flavorant which per paragraph 55, lines 2-3 may be pre-mixed ion the liquid, where flavorant itself is not considered an organic solvent, or may be separate from the e-liquid per paragraph 55, lines 4-6, and therefore not included in the formulation above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a liquid composition comprising more than 80% of water, 1% of a substance having a biological effect under inhaling conditions, and up to 10% of a polyol, said liquid composition being substantially free of additional organic solvent, as taught by Hejazi, as a known liquid compound for dispensing via a device for delivering microdroplets to a user for inhalation thereof.
Regarding claim 22, Dittmann in view of Danek, Hejazi, and Courbat disclose the method according to claim 19, as discussed above.
Presently modified Dittmann further discloses said liquid composition comprising one flavour (Hejazi: paragraph 55, lines 14-16).
Regarding claim 23, Dittmann in view of Danek, Hejazi, and Courbat disclose the method according to claim 19, as discussed above.
Presently modified Dittmann further discloses said substance being nicotine (Hejazi: paragraph 55, lines 19-20).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329), Hejazi (US 2021/0084970), and Courbat (US 2017/0280771), as applied to claim 19 above, and in further view of Watson (US 2013/0069530).
Regarding claim 20, Dittmann in view of Danek, Hejazi, and Courbat disclose the method according to claim 19, as discussed above.
Modified Dittmann discloses wherein the ratio polyol/water in said liquid composition is comprised between 10/90 and 20/80 (Hejazi: paragraph 55, lines 3-16, note exemplary ratios of 80% water and 10% PG and 90% water and 10% PG, where 10/90 is part of the claimed range and 10/80 lies within the claimed range, MPEP 2131.03), and wherein said composition is stored in a closed tank (200 of Dittmann) adapted to be engaged within the device (Dittmann: paragraph 93, lines 1-8 and paragraph 104, lines 1-8; Fig. 2).
Modified Dittmann fails to disclose wherein the tank is sterile.
However, Watson teaches gas cartridges for use in a device, wherein the cartridge can be provided as a sterile storage component (paragraph 45, lines 1-7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of modified Dittmann to provide the tank as a sterile storage component, as taught by Watson, in order to allow for the capability of the substance aerosolized and delivered to a user to be provided as a sterile substance as desired, and based on the field of use of the device.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Dittmann (US 2023/0080902) in view of Danek (US 2020/0230329), Hejazi (US 2021/0084970), and Courbat (US 2017/0280771), as applied to claim 19 above, and in further view of Schaller (US 2022/0079211) and Watson (US 2013/0069530).
Regarding claim 21, Dittmann in view of Danek, Hejazi, and Courbat disclose the method according to claim 19, as discussed above.
Dittmann discloses wherein said liquid composition is stored in a recipient (200 of Dittmann) usable to refill the device (Dittmann: paragraph 93, lines 1-8 and paragraph 104, lines 1-8; Fig. 2).
Modified Dittmann fails to disclose wherein the ratio of polyol/water is greater than 20/80, and that the recipient is non-sterile.
However, Schaller teaches a ratio of polyol/water of greater than 20/80, where the ratio can be manipulated in order to change the overall nicotine retention (see Table 5, and the ratio of water to PG+VG in Examples B and E, where the percentage of water remains at 60%, but where 29.2/60 is greater than 20/80; see nicotine retention of Table 5; paragraph 255, lines 1-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ratio of polyol/water to be greater than 20/80, as taught by Schaller, in order to manipulate the nicotine retention of the formulation as desired.
Further modified Dittmann fails to disclose wherein the recipient is non-sterile.
However, Watson teaches gas cartridges for use in a device, wherein the cartridge can be provided as a non-sterile storage component (paragraph 45, lines 1-7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of modified Dittmann to provide the tank as a non-sterile storage component, as taught by Watson, in order to allow for the capability of the substance aerosolized and delivered to a user to be provided as a non-sterile substance as desired, and based on the field of use of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Silvestrini (US 2023/0225013), at Figure 2B, includes a heater assembly 120 disposed on a lateral wall at a heater mount 134.
Kim (WO 2022/119239), at Figure 7, includes a preheating chamber 200 that surrounds an aerosol chamber 150.
Yoon (WO 2021/245283) includes, at Figure 5, a preheating chamber 130a/b that encloses heaters 120a/b.
Quarmby (WO 2021/025363), at Figure 5, shows an element 130b partially surrounding an aerosol chamber 110.
Paprocki (US 2016/0255879) includes several heaters 20/20’ and an elongated chamber where the heaters are contained to surround an interior chamber of the device (see Figs. 3-4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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