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 the Claims
Claims 14, 16-23 and 25-27 are pending and are subject to this Office Action. Claim 14 has been amended. Claim 15 has been cancelled. Claim 14 has been amended.
Response to Amendment
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.
On page 7, the Applicant argues that Besso relates exclusively to the use of a polymer matrix to encapsulate a flavorant, not to disperse an aerosol-generating formulation as recited in the Applicant’s claim language, which has different properties and characteristics from a polymer matrix to disperse an aerosol-generating formulation. The Examiner does not find this to be persuasive because both Kim and Besso teach beads for aerosol-generating devices where the beads are heated to release the material within the bead (see Kim [0038] where the bead is heated to form an aerosol and Besso [0044] where the flavour delivery material is released to temperatures above 220 C). Further, the encapsulating material/matrix of the beads of Kim and Besso both comprise similar materials such as alginate (see Kim [0045] and Besso [0036]). Even further, Besso is merely used to teach cross-linking of the polymer matrix of Kim, which Besso teaches has the advantage of structural strength and stability (see [0035]) which one of ordinary skill in the art would also find is advantageous for the bead of Kim.
On pages 7-8, the Applicant further argues that the claim requires the matrix-forming polymer to consist of alginate while Besso teaches the polymer matrix includes a combination of alginate and pectin. The Examiner does not find this to be persuasive because Besso teaches the polymer matrix may be formed from a single type of cross-linkable polymer [0035]. Further, Kim teaches alginate is a suitable solid continuous matrix structure ([0045] where alginate may be used instead of agar) and Besso is merely used to teach the benefit of cross-linking such a material.
In response to applicant's argument on page 8 that the use of alginate as the sole matrix-forming polymer has a number of advantages, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The following is a modified rejection based on amendments made to the claims.
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.
Claim(s) 14, 17-20 and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO2019/135618, citations will refer to the English translation previously provided) in view of Besso (US2015/0034099) and Kenichi (WO2020/148924, citations will refer to the English equivalent US2020/0397038).
Regarding claims 14, 16-17, 20, and 25, Kim discloses:
An aerosol-generating element for an aerosol-generating article or system (bead, [0037]-[0038]), the aerosol-generating element comprising:
A solid continuous matrix structure (the bead does not have a separate outer membrane, and has the shape of a bead as the materials, which includes agar, are mixed and dried [0038]-[0039], therefore agar is considered to be a solid continuous matrix structure).
An aerosol-generating formulation dispersed within the solid continuous matrix structure (the composition of the beads including glycerin, water, propylene glycol, nicotine, flavorings, etc. [0046]), wherein the aerosol-generating formulation is trapped within the solid continuous matrix structure and releasable from the solid continuous matrix structure upon heating of the aerosol-generating element (wherein the shape of a bead is maintained until it is liquefied of vaporized by a heater [0038]).
Wherein the solid continuous matrix structure is a polymer matrix comprising one or more matrix-forming polymers (agar, [0038]-[0039]).
Wherein the one or more matrix-forming polymers consists of alginate ([0045], where sodium alginate may be used instead of the agar).
Wherein the aerosol-generating formulation dispersed within the solid continuous matrix structure comprises at least one alkaloid or cannabinoid compound ([0046], nicotine). This reads on the limitation as recited in claim 20 wherein the at least one alkaloid or cannabinoid compound is selected from nicotine, anatabine, cannabidiol (CBD), and tetrahydrocannabinol (THC).
A polyhydric alcohol ([0046], glycerin, propylene glycol). This reads on the limitation as recited in claim 16 wherein the polyhydric alcohol is glycerin or propylene glycol.
Wherein a polyhydric alcohol content in the aerosol-generating formulation dispersed within the solid continuous matrix structure accounts for at least 30 percent by weight based on a total weight of the aerosol-generating element, as recited in claim 14, and at least 60 percent by weight, as recited in claim 17 (glycerin in an amount of 60 wt.% to 90 wt.%, [0006]).
Wherein the aerosol-generating element comprises from about 1 percent by weight to about 10 percent by weight of alginate (wherein agar is 2.5 wt.% of the bead [0006], and sodium alginate may be used instead of agar [00045], and therefore sodium alginate would be 2.5 wt.% of the bead).
And water in an amount of 7.5 wt.% to 37.5 wt.% ([0007]). The claimed range of less than about 20 percent by weight of water overlaps the range taught by the prior art and is therefore considered to be prima facie obvious.
The article can be manufactured in the shape of a sphere having a predetermined diameter…alternatively in an oval, droplet shape, etc. ([0037]).
Kim does not appear to disclose (I) wherein the solid continuous matrix structure is a cross-linked polymer matrix, (II) the equivalent diameter of the bead and (III) the ovality of the bead.
In regard to (I), Besso, directed to a smoking article, teaches:
A polymer matrix that is preferably a cross-linked polymer matrix. The cross-linking of the polymer forming the matrix provides structural strength and stability which improves the resistance of the polymer matrix to heat and shear forces [0035].
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the polymer matrix of Kim to be a cross-linked polymer matrix as taught by Besso, because both Kim and Besso are directed to polymer matrix structures of beads for use in smoking articles, Besso teaches cross-linking provides structural strength and stability, and this merely involves incorporating a known type of solid continuous matrix structure (i.e. cross-linked) to a similar polymer matrix to yield predictable results.
In regard to (II), Kenichi, directed to a capsule for smoking equipment, teaches:
Known diameters of capsules that fit in smoking equipment or aerosol-generating articles or systems (A capsule with a diameter that is…more preferably 2.5-4.5 mm [0028]).
Therefore, before the effective filing date of the claimed invention, as Kim is silent regarding suitable diameters of capsules or beads, it would be obvious for one having ordinary skill in the art to be motivated to look to other known teachings of capsules or beads for workable sizes that one of ordinary skill could apply to Kim with a reasonable expectation of success in them being suitably sized for a similar smoking article or system. As such, incorporating a suitable sized capsule or bead with a diameter of 2.5 to 4.5 mm as taught by Kenichi would read on the claim limitation wherein the aerosol-generating element has an equivalent diameter of at least about 0.5 millimeters, as recited in claim 14, and wherein the aerosol-generating element has an equivalent diameter of less than or equal to about 6 millimeters, as recited in claim 25.
In regard to (III), Kenichi, directed to a capsule for smoking equipment, teaches:
A capsule shape that preferably has a short diameter/long diameter ratio of 0.90-1.00, and more preferably 0.95-1.00. This ratio results in…excellent storage stability ([0034]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the bead of Kim by configuring the capsule shape to have a short diameter/long diameter ratio of 0.90-1.00 as taught by Kenichi, because both Kim and Kenichi are directed to capsules for smoking devices, Kenichi teaches this ratio provides the bead with excellent storage stability, and this merely involves incorporating a known short diameter/long diameter ratio to a similar bead for a smoking device to yield predicable results.
A capsule shape with a short diameter/long diameter ratio of 0.90 would yield an ovality of about 10.53%; a ratio of 0.95 would yield an ovality of 5.13%; and a ratio of 1.00 would yield an ovality of 0%. The claimed range of an ovality from about 2% to 30% overlaps the range taught by the prior art of an ovality of 0% to 10.53% and is therefore considered prima facie obvious.
Regarding claim 18, Kim further teaches:
Wherein the aerosol-generating formulation dispersed within the solid continuous matrix structure accounts for at least 80 percent by weight of the total weight of the aerosol-generating element ([0006], wherein the solid continuous matrix structure (i.e. agar or equivalents) is present is an amount of 2.5 wt.%, and therefore the remainder of the formulation being water and glycerine, which is the aerosol-generating formulation, must be 97.5 wt.%).
Regarding claim 19, Kim further teaches:
Wherein a content of the at least one alkaloid or cannabinoid compound in the aerosol-generating formulation dispersed within the solid continuous matrix structure accounts for at least 0.5 percent by weight of the total weight of the aerosol-generating element ([0046], where a bead may contain nicotine in an amount of 1.0%).
Regarding claim 26, as modified Kim teaches the bead to have an equivalent diameter of 2.5 to 4.5 mm, this would yield the aerosol-generating element to have an exposed surface area to volume ratio of 0.133 cm-1 to 0.24 cm-1, reading on the claim limitation wherein the aerosol-generating element has an exposed surface area to volume ratio from about 0.083 cm-1 to about 24 cm-1.
Regarding claim 27, Kim further teaches:
An aerosol-generating article for generating an aerosol upon heating (cigarette 100, figure 1, [0055]), the aerosol-generating article comprising:
A tubular element comprising a cavity defining a longitudinal airflow channel of the aerosol-generating article (bead receiving portion 120, figure 1, [0055], and wherein the arrow in figures 11-12 shows the direction of airflow [0110]-[0112]).
A plurality of aerosol-generating elements according to claim 14 (the beads as described with claim 14 previously, and multiple beads may be included in the read receiving portion [0057]).
The aerosol-generating elements being provided within the cavity such that an outer surface of the aerosol-generating elements is exposed inside the longitudinal airflow channel (as shown in figure 1).
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO2019/135618, citations will refer to the English translation previously provided) in view of Besso (US2015/0034099) and Kenichi (WO2020/148924, citations will refer to the English equivalent US2020/0397038) as applied to claim 14 above, and further in view of Capelli (WO 2019193210, cited in IDS dated 5/02/2022).
Regarding claims 21-22, Kim does not appear to explicitly disclose wherein the aerosol-generating formulation dispersed within the continuous solid matrix structure further comprises an acid.
Capelli, directed to a nicotine gel composition, further teaches:
The gel composition may further include an acid. The acid may comprise a carboxylic acid…such as levulinic acid or lactic acid (page 20, paragraph 2). This further reads on wherein the acid is lactic acid of levulinic acid as recited in claim 22.
Lactic acid surprisingly improves the stability of the gel composition even over similar carboxylic acids. The carboxylic acid may assist in the gel formation. The carboxylic acid may reduce variation of the alkaloid compound concentration, or the cannabinoid compound concentration (page 20, paragraph 2).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the beads of Kim by incorporating a carboxylic acid such as levulinic acid or lactic acid as taught by Capelli, because both Kim and Capelli are directed to nicotine gel compositions, Capelli teaches the carboxylic acid assists in the gel formation and reduces variability of the alkaloid concentration, and this merely involves incorporating a known aerosol-generating formulation ingredient (i.e. an acid) to a similar nicotine gel composition to yield predicable results.
Regarding claim 23, Capelli further teaches that preferably the carboxylic acid may be in a range from about 0.5% to about 3% by weight (page 20, paragraph 3), reading on the claim limitation wherein the acid content in the aerosol-generating formulation dispersed within the solid continuous matrix structure accounts for at least about 0.5 percent by weight of the total weight of the aerosol-generating element.
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 Nicole A Szumigalski whose telephone number is (703)756-1212. The examiner can normally be reached Monday - Friday: 8:00 - 4:30 EST.
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.
/N.A.S./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755