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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/26/2025 has been entered.
Status of the Claims
Claims 3, 4, 6-8, 10, 14, 15, 19, and 20 are pending and are subject to this office action. This office action is in response to Applicant’s amendment filed on 6/26/25.
Claims 3, 4, 6-8, 10, 14, 15, 19, and 20 are amended.
Claims 1, 11-13, and 18 are cancelled.
Response to Amendments/Arguments
Applicant's arguments (filed 6/26/25, pages 6-7) have been fully considered but are not persuasive. Applicant argues: Sears leads a person having ordinary skill in the art away from the present invention where it describes advantages associated with having gaps (i.e., interstitial air spaces) within the aerosol generating material ([0097]). The Examiner respectfully disagrees.
The preferred embodiments of Sears do not teach away from the claimed embodiment. The MPEP states “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” See MPEP § 2123(II). Here, while Sears teaches the advantages associated with having gaps within the aerosol generating material ([0097]), Sears also states the following:
In some aspects, the aerosol-generating element(s) 425 may include or otherwise comprise or be configured as, for example, marumarized tobacco beads of varying shapes and sizes, a monolith of bonded (e.g., sintered) beads; a porous monolith; a single porous structure; a honeycomb monolith; a single piece of a porous material; beads of extruded tobacco; beads of porous material containing tobacco extract (e.g., calcium carbonate, ceramic, or the like); reconstituted tobacco shreds; expanded tobacco shreds; extruded rods of various materials (including hollow cylinders and slotted rods) containing tobacco flavors; shavings, granules, capsules, and/or microcapsules of various materials containing tobacco flavors or other substances, whether in a liquid or other form; and treatments or combinations thereof. ([0092], emphasis added).
Here, Sears explicitly teaches that the aerosol-generating element 425 ([0091], Fig 3) may comprise various forms other than the beads and pellets discussed in Sears [0097]. It would be obvious to one having ordinary skill in the art from the disclosure of Sears that the aerosol-generating element 425 may comprise of a single piece of porous extruded material comprising various flavors and components. Thus, Sears does not teach away from the claimed composition.
The following rejections are maintained and modified where necessary based on Applicant’s amendments.
Claim Rejections - 35 USC § 103
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 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 3, 4, 6-8, 10, 14, 15, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sears (US 20170065000 A1) in view of Deforel (US 20210329964 A1).
Regarding Claim 14, Sears teaches an aerosol generating device for generating an inhalable medium, the device comprising:
a container for holding a liquid (reservoir substrate 214, [0084], Fig 3);
a heater for volatilizing a liquid held in the container (heating element 240 [0085], Fig 3);
a chamber containing a composition comprising an extruded material (second aerosol generation arrangement 400 and aerosol-generating element 425, [0091]-[0092], fig 3); and
an outlet (mouthpiece 220 [0091], Fig 3);
wherein the device is configured such that in use, an inhalable medium passes out of the outlet, the inhalable medium comprising (i) volatilized liquid in the form of a vapor and/or an aerosol, and (ii) one or more constituents of the composition retained in the chamber (the first aerosol produced by the heating element 240/atomizer 212 is directed through the porous matrix formed by the aerosol-generating element 425, wherein the heated vapors passing through and heating the porous aerosol-generating element 425 promotes the enhancement substance being entrained in or otherwise interacted with the first aerosol before passing through the mouthpiece 220. [0091], [0097], Fig 3), and
wherein the chamber is entirely filled with the composition (To the extent that the second aerosol generation arrangement 400 could be filled with a single porous structure, the second aerosol generation arrangement 400 may be entirely filled with the aerosol-generating elements 425 in the form of a single porous structure. [0092], [0103], Fig 3).
Sears does not teach a composition comprising an extruded material comprising a solid non-tobacco botanical material and no tobacco-derived components. However, Deforel teaches an aerosol-generating substrate directed to aerosol generating articles, including a homogenized plant material composition comprising:
a first extruded material ("The homogenised plant material used in substrates according to the invention may be produced by... extrusion" [0011]; [0054]),
wherein the first extruded material comprises a solid non-tobacco botanical material and no tobacco-derived components ("The particulate plant material may comprise no tobacco particles and 100 percent clove particles" [0008]),
further comprising a second extruded material comprising tobacco material ("The particulate plant material consists of clove material, or a mixture of clove material and tobacco material" [0008]. "the second homogenised plant material comprises a second particulate plant material with a major proportion of tobacco particles" [0062]),
a wetting agent ("The aerosol former may also have humectant type properties that help maintain a desirable level of moisture" [0040]),
a binder ("The homogenised plant material may comprise one or more binders" [0035]), and
a bulking agent (The homogenized plant material may comprise fillers. [0035]),
wherein a density of the first extruded material and a density of the second extruded material may each individually have a density of from about 0.7 gcm-3 to about 1.0 gcm-3 ([0046]).
Deforel does not explicitly disclose wherein a density of the first extruded material and a density of the second extruded material are within +/- 0.2 gcm-3. However, given that the density of the extruded material directly effects the weight of the composition and the quantity of inhalable substance within the inhalable medium, a person having ordinary skill in the art would be motivated to perform routine optimization. Moreover, particularly where Deforel teaches a narrow range of densities for the two extruded materials as discussed above, a person having ordinary skill in the art would have a reasonable expectation of success through experimentation of determining a preferred user range of the two materials such that the densities of the two materials are within +/- 0.2 gcm-3. Therefore, it follows that a person having ordinary skill in the art, through routine optimization of comparative densities of the two materials as disclosed in Deforel, would arrive at the densities of the two materials within +/- gcm-3 as claimed, absent evidence to the contrary. See MPEP 2144.05(II).
Therefore, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify the aerosol-generating elements comprising a single porous structure of Sears by using the substrate composition as taught by Deforel, because Sears and Deforel are both directed to aerosol-generating systems, Deforel teaches that extruded aerosol compositions comprising entirely of solid botanicals and no tobacco-derived components are known in the art and may be used to provide a smoking experience without tobacco or nicotine, and this merely involves replacing one aerosol-forming composition with another to yield predictable results.
Regarding claim 3, Deforel teaches that the homogenized plant material comprises clove material ([0007)).
Regarding claim 4, Deforel teaches wherein the first extruded material comprises from about 40 wt% to about 90 wt% of the solid non-tobacco botanical material. (The homogenized plant material comprises particulate plant material which comprises from about 10-100 wt% clove particles. [0008]. A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05(I).)
Regarding claim 6, Sears further teaches that aerosol forming substrates may comprise a plurality of granules formed through spherical extrusion ([0093], [0101)).
Regarding claim 7, Sears further teaches wherein an average particle size of the plurality of granules is in the range of about 0.4 mm to about 3.5 mm. (The mean particle diameter may range from 0.05mm — 4mm [0100]. A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05(I).)
Regarding claim 8, Deforel teaches wherein the first extruded material has a density in the range of about 0.4 gcm-3 to about 1.5 gcm-3 (The first extruded material may have a density in the range of about 0.3 gcm-3 to about 1.3 gcm-3. [0046]. A prima facie case of obviousness exists where claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP § 2144.05(I).)
Regarding claim 10, Sears teaches that aerosol forming substrates directed to aerosol delivery devices may comprise a plurality of granules formed through spherical extrusion ([0093], [0101]). Sears further teaches that aerosol-generating element may be a mixture of different compositions ([0104)).
Regarding claim 15, Sears teaches wherein the device is configured such that in use, liquid volatilized by the heater passes, in the form of an aerosol, through the chamber to thereby entrain one or more constituents from the composition retained therein to produce the inhalable medium which passes out of the outlet (“. . . the heat and the first aerosol . . . produced by the heating element 240/atomizer 212 are directed through the porous matrix formed by the aerosol- generating element(s) 425, wherein the heated vapors passing through and heating the porous aerosol-generating element(s) 425 promotes, for example, elution . . . of an enhancement substance . . . from the aerosol-generating element(s) to the first aerosol . ..” [0097)).
Regarding claim 19, Deforel teaches the aerosol-generating substrate may further comprise tobacco particles ([0008]) and the tobacco particles contain nicotine ([0010)).
Regarding claim 20, Deforel teaches the aerosol-generating substrate comprising homogenized plant material with 100 wt% clove material ([0008)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey Buckman whose telephone number is (571)270-0888. The examiner can normally be reached Monday-Friday 8:00-4:00.
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, Philip Louie can be reached at (571)270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEFFREY A. BUCKMAN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755