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 .
Response to Arguments
Applicant's arguments filed 6/29/2026 have been fully considered but they are not persuasive.
The arguments regarding claim amendments are addressed in the rejections below.
The applicant argues that the examiner does not give any rationale as to why the aerosol as recited in claim 1 must be limited to a single activation or as to why the asserted composition must be an entire reservoir of liquid. The examiner disagrees. The examiner is basing the understanding of the invention on the applicant’s specification as stated in the rejection. In particular, the only method and device disclosed operates in a puff by puff operation with a liquid reservoir [0004] and a reservoir [0008] that contains the composition. While no device is claimed, the rejection is based on the lack of enablement as no device or method is disclosed that generates an aerosol that has 88% by weight of nicotine in a particulate phase with respect to the total weight of the composition. The addition of the limitation, “that forms the aerosol” does not rectify the rejection and enable the invention. The composition as disclosed is still the composition in the reservoir as there is no other disclosure of another composition.
In addition, figure 7 of the instant specification indicates that gas a particulate phase concentrations. However, there is no disclosure that these are in relation to the liquid composition that was vaporized/aerosolized. It appears that the relationship shown is entirely what is recovered during the testing process disclosed and not related to the composition.
The applicant argues that the rejection over Lechuga-Ballesteros does not mention gas phase.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Lechugh-Ballesteros does not mention a gas phase) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The applicant argues that the lack of disclosure of Lechuga-Ballesteros regarding gas phase does not constitutes disclosure of an aerosol including 100% particulate nicotine. The examiner does not content that Lechuga-Ballesteros discloses particulate by lack of disclosure. Instead, the disclosure of Lechuga-Ballesteros indicates that the composition is composed of particles that are aerosolized and it would have been inherent that in the invention as disclosed by Lechuga-Ballesteros that the aerosol would have been formed of these particles. Particles are further described [0053]. Lechuga-Ballesteros disclose the operation of metered-dose inhalers and describe the mechanism of suspending particles in a carrier which then dispenses the particles in a very fine particle size [0006]. In other words, the nicotine of Lechuga-Ballesteros is not in the gas phase.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 78-82 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an aerosol comprising nicotine and an ion pairing agent comprising lactic acid it does not reasonably provide enablement for 85% of the nicotine by weight of the composition that forms the aerosol, or from which the aerosol is produced, to be in a particulate phase of the aerosol. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce the aerosol of the invention commensurate in scope with these claims.
The device as described in the specification is an electronic cigarette that produces aerosol in a puff by puff method [0004] where a small portion of the composition is aerosolized. The composition, which is not claimed in claim 78, is the entire fluid reservoir that is used for numerous puffs. At no time during the use of an electronic cigarette will 85% of the nicotine in the composition be in aerosol and be in either the particulate phase or the vapor phase because a majority of the nicotine in the composition will be in the liquid state within the device. Therefore, the device as disclosed is incapable of producing an aerosol where at least 85% of the nicotine by weight of the total weight of the composition is in a particulate phase of the aerosol.
The claims are broad and drawn to an aerosol with a specific amount of nicotine in the particulate phase based on the composition that contains nicotine. Aerosols are transient and highly dependent on (1) the composition of the material to be aerosolized, (2) the device being used to form the aerosol, and (3) the environmental conditions such as temperature and humidity. The prior art devices and compositions are well known. However, a device that forms an aerosol that has 85% of the entire composition in the particulate phase at one time is not known. Although one of ordinary skill has knowledge to make and use puff based aerosol generators, one of ordinary skill would not know how to make an aerosol generator that could produce the aerosol that would have 85% of the nicotine by weight of the total composition. As indicated above, the specification provides support for 85% of the nicotine in an aerosol to be in the particulate phase and not in the vapor phase. This is fundamentally different than 85% of the nicotine in a composition being in a particulate phase. No working examples are present where 85% of nicotine in the composition is in the aerosol phase. Therefore, undue experimentation would be required to form an aerosol that contains 85% of the nicotine by weight of a composition. For instance, an inventor would need to develop a way to form either a large amount of aerosol from the entire composition instantaneously before condensation of the aerosol onto surfaces can occur.
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(s) 78-82 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lechuga-Ballesteros et al. (US 2006/0018840).
Regarding claims 78, 81, and 82, Lechuga-Ballesteros et al. disclose an aerosol produced from a composition of a free base nicotine, an organic acid (including lactic acid) and a solvent (i.e. propellant and cosolvent [0034]). The molar ratio between the nicotine and organic acid can range from 0.25:1 to about 4:1 (Abstract, [0033]). Lechuga-Ballesteros et al. further state that when the metered dose inhaler is used, “Particles comprising nicotine/organic are aerosolized in a form where they may be inhaled by a user.” [0055] The aerosol produced in the invention of Lechuga-Ballesteros et al. does not contain nicotine in vapor form (100% nicotine by weight with respect to the total weight of the composition is in a particle phase of the aerosol, please see the 112 rejection above).
Regarding claim the limitation, “wherein the aerosol is produced by vaporization and condensation of a composition comprising nicotine, the at least one solvent, and the at least one ion pairing agent comprising lactic acid and wherein at least 85% of the nicotine by weight with respect to the total weight of the composition that forms the aerosol is in a particulate phase of the aerosol”, Lechuga-Ballesteros et al. disclose a different process for producing an aerosol. The steps and parameters (including composition) for the process for producing an aerosol do not add patentable details to this invention, as no structural characteristics concerning the aerosol are association with the step in the specification. As such, this is a “product by process” claim.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113).
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) …
"[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Regarding claims 79 and 80, the nicotine particles in the aerosol of Lechuga-Ballesteros et al. have a mass median aerodynamic diameter (MMAD) of 0.5 micrometers to 5.0, with preferred ranges of about 1 to about 3 micrometers, which anticipates the ranges of 0.2 to 4 micrometers and the range of about 0.5 micrometer and 1 micrometer.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J FELTON whose telephone number is (571)272-4805. The examiner can normally be reached Monday, Thursday-Friday 7:00-4:30, Wednesday 7:00-1:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael J Felton/Primary Examiner, Art Unit 1747
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