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 II, claims 78-82 in the reply filed on 10/03/2025 is acknowledged.
Claims 70-77 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse as noted above.
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 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, 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schweizer et al. (US 4,236,532)
Diamond et al. (Minutes of the Nicotine Aerosol Meeting, Smoking and Health Program, 1976).
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.
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/Michael J Felton/Primary Examiner, Art Unit 1747