DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
Claims 1, 3-5, 7, 11, 13, 15, 17-18, 20, 23-26, 28, 30, and 32 are pending. Claims 23-26, 28, 30, and 32 are withdrawn. Claims 1 and 23 have been amended.
Response to Amendments
The Examiner acknowledges Applicant's response filed on 12/23/2025 containing amendments and remarks to the claims.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
As noted in the Remarks, “Applicant has amended independent claim 1 to include functional limitations that impose structural requirements on the air inlet, flow passage, outlet and the vaporization chamber”. As discussed in the prior art rejection of claim 1 below, the apparatus of prior art reference Wensley has been concluded to inherently possess this functionally defined limitation. As such, the burden is on the “applicant to establish that the prior art does not possess the characteristic relied upon” (MPEP § 2114(I)). Applicant has not satisfied this burden.
Applicant argues that “Wensley does not take into account a vaporizer element region extending outwardly from the vaporizer element to a distance of 1 mm from the vaporizer element surface.” The argument is not persuasive as the prior art is not required to disclose an arbitrary definition as long as the prior art discloses the resulting structure. Applicant defined a ‘vaporizer element region’ as a volume extending outwardly from the vaporizer element surface to a distance of 1 mm from the vaporizer element surface. It is not defined by any terminating wall or structure, and the boundary of the region can be in midair. Wensley discloses a vaporizer element, the vaporizer element has a surface, and there is a region 1 mm away from the vaporizer element surface. As such, the apparatus of Wensley has a vaporizer element region.
Applicant further argues that “the apparatus of Wensley might be capable of being operated under the same test conditions, but it would not provide the specified maximum magnitude of velocity of air or particle size under the conditions provided in claim 1.” This argument is not persuasive as Applicant has provided no evidence for this assertion. Arguments presented by the applicant cannot take the place of evidence in the record (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984), MPEP § 716.01(c)).
Applicant further argues that “Wensley teaches generating large particle sizes by reducing flow through the vaporization chamber as a whole so would only produce ‘the generated aerosol having a Dv50 in the range 2-3μm’ at lower flow rates” (Remarks at Page 10) and that Applicant’s alleged “inventive concept is . . . providing large particles at relatively high rates of air flow” (Remarks at 11). This argument is not persuasive as claim 1 is explicitly only concerned with a hypothetical flow rate of 1.3 L min-1 which Applicant explicitly states is a low flow rate (“The present inventors consider that a flow rate of 1.3 L min-1 is towards the lower end of a typical user expectation of flow rate through a conventional cigarette and therefore through a user-acceptable smoking substitute apparatus”, ¶ 0023 of the Specification as originally filed).
Applicant further argues that Wensley “suggests that rapid airflow decreases particle size”. This argument is not persuasive as Applicant also suggests that rapid airflow decreases particle size as Applicant’s Fig. 12 shows a decrease in particle size as the velocity of airflow increases.
Applicant further argues that Wensley “provides no teaching of how particles could be produced at high overall flow rates” (Remarks at 12). This argument is not persuasive as claim 1 is explicitly only concerned with a hypothetical flow rate of 1.3 L min-1 which Applicant explicitly states is a low flow rate (“The present inventors consider that a flow rate of 1.3 L min-1 is towards the lower end of a typical user expectation of flow rate through a conventional cigarette and therefore through a user-acceptable smoking substitute apparatus”, ¶ 0023 of the Specification as originally filed).
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.
Claims 1, 3-5, 7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wensley et al. (US 2015/0196060 A1).
Regarding claim 1, Wensley discloses a smoking substitute apparatus (“aerosol generating device”, Fig. 2, ¶ 0034) having:
an air inlet (“First Air Inlet (214)”, Fig. 2, ¶ 0034);
an outlet (“Outlet (216)”, Fig. 2, ¶ 0034);
a flow passage (“air flow channel”, ¶ 0034) formed between the air inlet and the outlet (Fig. 2);
a vaporization chamber (“aerosol generation region” encapsulated by “Liquid Substrate (208)”, Fig. 2, ¶ 0034) in communication with the flow passage (Fig. 2), the vaporization chamber having an aerosol generator (“Heater Element 206”, Fig. 2, ¶ 0034) configured to generate an aerosol (“aerosol”, ¶ 0034) from an aerosol precursor (“Liquid Substrate (208)”, Fig. 2, ¶ 0034) by heating (¶ 0034),
wherein the aerosol generator comprises:
a vaporizer element (“wicking element”, ¶ 0031) loaded with aerosol precursor (“liquid formulation comprising nicotine”, ¶ 0031), the vaporizer element being heatable by a heater (“electrically resistive wire”, ¶ 0031) and presenting a vaporizer element surface to air in the vaporization chamber (Fig. 2),
a vaporizer element region being defined as a volume extending outwardly from the vaporizer element surface to a distance of 1 mm from the vaporizer element surface (not labeled in Fig. 2, but the region equal to the volume extending outwardly from the vaporizer element surface to a distance of 1 mm from the vaporizer element surface).
Wensley does not explicitly state a maximum magnitude of velocity of air in the vaporizer element region when the air flow rate inhaled by the user between the inlet and outlet through the vaporization chamber and the flow passage is precisely 1.3 L min-1 when the aerosol precursor is an e-liquid consisting of 1.6% freebase nicotine and the remainder a 65:35 propylene glycol and vegetable glycerin mixture, the e-liquid having a boiling point of 209 °C, air being drawn into the air inlet at a temperature of 25 °C, and the vaporizer operated to release a vapor of total particulate mass 5 mg over a 3 second duration from the vaporizer element surface in an air flow rate between the air inlet and outlet of 1.3 L min-1, the generated aerosol having a Dv50 in the range 2-3 μm to determine if the maximum magnitude of velocity of air is within the claimed range.
However, Wensley discloses optimizing the sizes of aerosol particles “by controlling the linear flow rate for a carrier gas (e.g., air) over a heater element” relative to “a given volumetric flow rate” (¶ 0024). Wensley further discloses varying the dimensions of an orifice through which the air flows (¶ 0043) by “modifying the cross-sectional area of the region of the device comprising the heater element (e.g., aerosol generation region) to increase or decrease linear carrier gas (e.g., air) velocity for a given volumetric flow rate” (¶ 0024). Further, Wensley discloses that the orifice may be formed so large that it has a diameter of up to 3 inches (¶ 0043). Per a given air flow rate, the velocity of air decreases with an increase in cross-sectional area. An orifice with a diameter of 3 inches results in a cross-sectional area that is orders of magnitude larger than even the largest area disclosed by Applicant (see, e.g., Applicant’s Fig. 3). As such, the preponderance of the evidence indicates that the maximum velocity of air through the vaporizer element region of Wensley with such an orifice would be less than the smallest maximum velocity of air disclosed by Applicant and, therefore, fall within the claimed range of 0-1.2 ms-1. As the maximum velocity of air through the vaporizer element region falls within the claimed range and Applicant states that such a maximum velocity results in the generated aerosol having a Dv50 within a range of 2-3 μm (see Applicant’s Fig. 12), the preponderance of evidence further indicates that when the aerosol precursor is an e-liquid consisting of 1.6% freebase nicotine and the remainder a 65:35 propylene glycol and vegetable glycerin mixture, the e-liquid having a boiling point of 209 °C, air being drawn into the air inlet at a temperature of 25 °C, and the vaporizer operated to release a vapor of total particulate mass 5 mg over a 3 second duration from the vaporizer element surface in an air flow rate between the air inlet and outlet of 1.3 L min-1, the generated aerosol will inherently have a Dv50 in the range 2-3 μm (MPEP § 2114(I)).
Regarding claim 3, Wensley teaches a smoking substitute apparatus of claim 1, as discussed above.
Wensley does not explicitly state a maximum magnitude of velocity of air in the vaporizer element region when the air flow rate inhaled by the user through the apparatus is precisely 2.0 L min-1 to determine if the maximum magnitude of velocity of air is within the claimed range.
However, Wensley discloses optimizing the sizes of aerosol particles “by controlling the linear flow rate for a carrier gas (e.g., air) over a heater element” relative to “a given volumetric flow rate” (¶ 0024). Wensley further discloses varying the dimensions of an orifice through which the air flows (¶ 0043) by “modifying the cross-sectional area of the region of the device comprising the heater element (e.g., aerosol generation region) to increase or decrease linear carrier gas (e.g., air) velocity for a given volumetric flow rate” (¶ 0024). Further, Wensley discloses that the orifice may be formed so large that it has a diameter of up to 3 inches (¶ 0043). Per a given air flow rate, the velocity of air decreases with an increase in cross-sectional area. An orifice with a diameter of 3 inches results in a cross-sectional area that is orders of magnitude larger than even the largest area disclosed by Applicant (see, e.g., Applicant’s Fig. 3). As such, the preponderance of the evidence indicates that the maximum velocity of air through the vaporizer element region of Wensley with such an orifice would be less than the smallest maximum velocity of air disclosed by Applicant and, therefore, fall within the claimed range of 0-2.0 ms-1.
Regarding claim 4, Wensley teaches a smoking substitute apparatus of claim 3, as discussed above.
Wensley does not explicitly state a maximum magnitude of velocity of air in the vaporizer element region when the air flow rate inhaled by the user through the apparatus is precisely 2.0 L min-1 to determine if the maximum magnitude of velocity of air is within the claimed range.
However, Wensley discloses optimizing the sizes of aerosol particles “by controlling the linear flow rate for a carrier gas (e.g., air) over a heater element” relative to “a given volumetric flow rate” (¶ 0024). Wensley further discloses varying the dimensions of an orifice through which the air flows (¶ 0043) by “modifying the cross-sectional area of the region of the device comprising the heater element (e.g., aerosol generation region) to increase or decrease linear carrier gas (e.g., air) velocity for a given volumetric flow rate” (¶ 0024). Further, Wensley discloses that the orifice may be formed so large that it has a diameter of up to 3 inches (¶ 0043). Per a given air flow rate, the velocity of air decreases with an increase in cross-sectional area. An orifice with a diameter of 3 inches results in a cross-sectional area that is orders of magnitude larger than even the largest area disclosed by Applicant (see, e.g., Applicant’s Fig. 3). As such, the preponderance of the evidence indicates that the maximum velocity of air through the vaporizer element region of Wensley with such an orifice would be less than the smallest maximum velocity of air disclosed by Applicant and, therefore, fall within the claimed range of at most 0.6 ms-1.
Regarding claim 5, Wensley teaches a smoking substitute apparatus of claim 1, as discussed above. Wensley further discloses the apparatus is operable such that the aerosol has a Dv50 (i.e., a volumetric median diameter) of more than 1 µm (“the diameter of the aerosol particles can be a volumetric median diameter (VMD) of about 1 µm to about 5 µm”, ¶ 0027). Since the range about 1 µm to about 5 µm falls within the claimed range of more than 1 µm, the range is anticipated (MPEP § 2131.03).
Regarding claim 7, Wensley teaches a smoking substitute apparatus of claim 1, as discussed above.
Wensley does not explicitly state an average magnitude of velocity of air in the vaporizer chamber when the air flow rate inhaled by the user through the apparatus is precisely 1.3 L min-1 to determine if the average magnitude of velocity of air is within the claimed range.
However, Wensley discloses optimizing the sizes of aerosol particles “by controlling the linear flow rate for a carrier gas (e.g., air) over a heater element” relative to “a given volumetric flow rate” (¶ 0024). Wensley further discloses varying the dimensions of an orifice through which the air flows (¶ 0043) by “modifying the cross-sectional area of the region of the device comprising the heater element (e.g., aerosol generation region) to increase or decrease linear carrier gas (e.g., air) velocity for a given volumetric flow rate” (¶ 0024). Further, Wensley discloses that the orifice may be formed so large that it has a diameter of up to 3 inches (¶ 0043). Per a given air flow rate, the velocity of air decreases with an increase in cross-sectional area. An orifice with a diameter of 3 inches results in a cross-sectional area that is orders of magnitude larger than even the largest area disclosed by Applicant (see, e.g., Applicant’s Fig. 3). As such, the preponderance of the evidence indicates that the average velocity of air through the vaporizer chamber of Wensley with such an orifice would be less than the smallest average velocity of air disclosed by Applicant and, therefore, within the claimed range of 0-1.3 ms-1.
Regarding claim 11, Wensley teaches a smoking substitute apparatus of claim 1, as discussed above.
Wensley does not explicitly state an average magnitude of velocity of air in the vaporizer element region when the air flow rate inhaled by the user through the apparatus is precisely 2.0 L min-1 to determine if the average magnitude of velocity of air is within the claimed range.
However, Wensley discloses optimizing the sizes of aerosol particles “by controlling the linear flow rate for a carrier gas (e.g., air) over a heater element” relative to “a given volumetric flow rate” (¶ 0024). Wensley further discloses varying the dimensions of an orifice through which the air flows (¶ 0043) by “modifying the cross-sectional area of the region of the device comprising the heater element (e.g., aerosol generation region) to increase or decrease linear carrier gas (e.g., air) velocity for a given volumetric flow rate” (¶ 0024). Further, Wensley discloses that the orifice may be formed so large that it has a diameter of up to 3 inches (¶ 0043). Per a given air flow rate, the velocity of air decreases with an increase in cross-sectional area. An orifice with a diameter of 3 inches results in a cross-sectional area that is orders of magnitude larger than even the largest area disclosed by Applicant (see, e.g., Applicant’s Fig. 3). As such, the preponderance of the evidence indicates that the average velocity of air through the vaporizer element region of Wensley with such an orifice would be less than the smallest average velocity of air disclosed by Applicant and, therefore, within the claimed range of 0-1.2 ms-1.
Claims 13, 15, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wensley et al. (US 2015/0196060 A1) as applied to claim 1 above, and further in view of Dubief (US 2014/0334802 A1).
Regarding claim 13, Wensley teaches a smoking substitute apparatus of claim 1, as discussed above.
Wensley does not explicitly state the turbulence intensity when the air flow rate by the user through the apparatus is 1.3 L min-1 to determine if the turbulence intensity falls within the claimed range.
However, Applicant discloses that the advantage of controlling the turbulence intensity is that it “permits the generation of aerosols with particularly advantageous particle size characteristics, including Dv50 values” (¶ 0051 of Applicant’s Specification as originally filed). Similarly, Dubief, in the same field of endeavor, discloses optimizing the particle sizes characteristics by minimizing “turbulence” to create “a relatively homogeneous air flow through the aerosol forming chamber” (¶ 0082). Further, adjusting the apparatus to minimize the turbulence intensity is a routine matter as Dubief discloses it may be accomplished by reducing the distance between the air flow vents and the heater and by arranging the air flow vents symmetrically (¶ 0082). As such, it would have been routine optimization to arrive at the claimed invention, and a person of ordinary skill in the art before the Application’s effective filing date would have had a reasonable expectation of success in making the apparatus satisfying the claimed range. Therefore, claim 13 is unpatentable over Wensley in view of Dubief as Dubief discloses the general conditions of the claimed range, and it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05(II)(A & B)).
Regarding claim 15, Wensley teaches a smoking substitute apparatus of claim 1, as discussed above.
Wensley does not explicitly state the time it takes to cool a specific e-liquid mixture to determine if falls within the claimed range.
However, Applicant discloses that the advantage of “imposing a relatively slow cooling rate on the vapor” in that it “has the effect of generating aerosols with a relatively large particle size” (¶ 0052 of Applicant’s Specification as originally filed). Similarly, Dubief, in the same field of endeavor, discloses relatively slow cooling rates result in relatively large particle sizes (Dubief discloses “increasing the cooling rate, which decreases the mean particle size in the aerosol”, ¶ 0082; from this statement, the contrapositive of a decrease in cooling rate corresponding to a relatively large particle size is disclosed). Further, adjusting the apparatus to decrease the cooling rate is a routine matter as Dubief discloses it may be accomplished by adjusting the air flow rate (¶ 0082). As such, it would have been routine optimization to arrive at the claimed invention, and a person of ordinary skill in the art before the Application’s effective filing date would have had a reasonable expectation of success in making the apparatus satisfying the claimed range. Therefore, claim 15 is unpatentable over Wensley in view of Dubief as Wensley discloses a benefit to increasing the average particle size (see Wensley ¶ 0024) and Dubief discloses the general conditions of the claimed range, and it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05(II)(A & B)).
Regarding claim 17, Wensley in view of Dubief teaches a smoking substitute apparatus of claim 15, as discussed above.
Wensley in view of Dubief does not explicitly state the time it takes to cool a specific e-liquid mixture to determine if falls within the claimed range.
However, Applicant discloses that the advantage of “imposing a relatively slow cooling rate on the vapor” in that it “has the effect of generating aerosols with a relatively large particle size” (¶ 0052 of Applicant’s Specification as originally filed). Similarly, Dubief discloses relatively slow cooling rates result in relatively large particle sizes (Dubief discloses “increasing the cooling rate, which decreases the mean particle size in the aerosol”, ¶ 0082; from this statement, the contrapositive of a decrease in cooling rate corresponding to a relatively large particle size is disclosed). Further, adjusting the apparatus to decrease the cooling rate is a routine matter as Dubief discloses it may be accomplished by adjusting the air flow rate (¶ 0082). As such, it would have been routine optimization to arrive at the claimed invention, and a person of ordinary skill in the art before the Application’s effective filing date would have had a reasonable expectation of success in making the apparatus satisfying the claimed range. Therefore, claim 17 is unpatentable over Wensley in view of Dubief as Wensley discloses a benefit to increasing the average particle size (see Wensley ¶ 0024) and Dubief discloses the general conditions of the claimed range, and it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05(II)(A & B)).
Regarding claim 18, Wensley teaches a smoking substitute apparatus of claim 1, as discussed above.
Wensley does not explicitly state the time it takes to cool a specific e-liquid mixture to determine if falls within the claimed range.
However, Applicant discloses that the advantage of “imposing a relatively slow cooling rate on the vapor” in that it “has the effect of generating aerosols with a relatively large particle size” (¶ 0052 of Applicant’s Specification as originally filed). Similarly, Dubief, in the same field of endeavor, discloses relatively slow cooling rates result in relatively large particle sizes (Dubief discloses “increasing the cooling rate, which decreases the mean particle size in the aerosol”, ¶ 0082; from this statement, the contrapositive of a decrease in cooling rate corresponding to a relatively large particle size is disclosed). Further, adjusting the apparatus to decrease the cooling rate is a routine matter as Dubief discloses it may be accomplished by adjusting the air flow rate (¶ 0082). As such, it would have been routine optimization to arrive at the claimed invention, and a person of ordinary skill in the art before the Application’s effective filing date would have had a reasonable expectation of success in making the apparatus satisfying the claimed range. Therefore, claim 18 is unpatentable over Wensley in view of Dubief as Wensley discloses a benefit to increasing the average particle size (see Wensley ¶ 0024) and Dubief discloses the general conditions of the claimed range, and it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05(II)(A & B)).
Regarding claim 20, Wensley in view of Dubief teaches a smoking substitute apparatus of claim 18, as discussed above.
Wensley in view of Dubief does not explicitly state the time it takes to cool a specific e-liquid mixture to determine if falls within the claimed range.
However, Applicant discloses that the advantage of “imposing a relatively slow cooling rate on the vapor” in that it “has the effect of generating aerosols with a relatively large particle size” (¶ 0052 of Applicant’s Specification as originally filed). Similarly, Dubief discloses relatively slow cooling rates result in relatively large particle sizes (Dubief discloses “increasing the cooling rate, which decreases the mean particle size in the aerosol”, ¶ 0082; from this statement, the contrapositive of a decrease in cooling rate corresponding to a relatively large particle size is disclosed). Further, adjusting the apparatus to decrease the cooling rate is a routine matter as Dubief discloses it may be accomplished by adjusting the air flow rate (¶ 0082). As such, it would have been routine optimization to arrive at the claimed invention, and a person of ordinary skill in the art before the Application’s effective filing date would have had a reasonable expectation of success in making the apparatus satisfying the claimed range. Therefore, claim 18 is unpatentable over Wensley in view of Dubief as Wensley discloses a benefit to increasing the average particle size (see Wensley ¶ 0024) and Dubief discloses the general conditions of the claimed range, and it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05(II)(A & B)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.G.C./Examiner, Art Unit 1747
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759