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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/27/2026 has been entered.
Status of the Claims
Claims 14, 16-23, and 25-28 are pending and are subject to this Office Action. Claim 14 has been amended. Claim 28 is newly added.
Response to Amendment
The Examiner acknowledges Applicant’s response filed on 4/27/2026 containing
amendments and remarks to the claims.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive.
On page 7, the Applicant argues a person of ordinary skill in the art could have chosen any of the five listed alternatives and would not have necessarily selected alginate from this list. The Applicant further argues the Office Action does not articulate a nonhindsight rationale explaining why the person of ordinary skill in the art would have chosen only alginate in an amount of 2.5% from among the five listed alternatives in Kim.
The Examiner does not find this to be persuasive. Kim teaches agar present in an amount of 2.5 wt.% ([0006]). Further, paragraph [0045] of Kim recites: “Additionally, instead of the agar described above, gums such as pectin, sodium alginate, carrageenan, gelatin, or guar gum may be used”. Therefore, it would be obvious to one of ordinary skill in the art to substitute the agar with sodium alginate, as taught by Kim, to arrive at sodium alginate in an amount of 2.5 wt.%. This merely involves simple substitution of one known type of gum in an aerosol generating bead for another known type of gum in an aerosol generating bead to yield the predictable result of a bead that generates an aerosol when heated. Further, Kim teaches the listed alternatives to agar and the selection of a known material based on its suitability for its intended use supports prima facie obviousness. See MPEP § 2144.07.
On pages 7-8, the Applicant argues they are not relying on a newly recognized benefit of an otherwise suggested modification, but rather the cited references fail to establish that the person of ordinary skill in the art would have had a reasonable expectation that selecting alginate alone and at the claimed concentrations would yield a bead that remains structurally stable, self-supporting, and configured for controlled aerosol release when heated, particularly in the presence of high polyhydric alcohol content and reduced water levels. The Examiner does not find this to be persuasive.
First, the claim does not require the bead to remain structurally stable, self-supporting, and configured for controlled aerosol release when heated. The claim merely requires the aerosol-generating formulation dispersed within the solid continuous matrix structure and wherein the formulation is trapped within the structure and releasable from the structure upon heating of the aerosol generating element, of which Kim teaches. Next, as Kim teaches sodium alginate may be used instead of agar, a person of ordinary skill in the art would have had a reasonable expectation that using sodium alginate instead of agar would achieve the predictable result of a bead that generates an aerosol when heated. Further, the Applicant appears to allege that the claimed bead has a newly recognized benefit of a bead that remains structurally stable, self-supporting, and configured for controlled aerosol release when heated. However, the discussion of why a person of ordinary skill in the art would have selected alginate at the claimed concentration was discussed previously, and this benefit would flow naturally from following the suggestion from the prior art.
On page 8, the Applicant argues Kim at best teaches alginate in an amount of 2.5 wt.%, in contrast to the Applicant’s claim language which recites alginate to be present in an amount of at least 3%. The Examiner does not find this to be persuasive.
First, the Courts have held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP § 2144.05 (I). Therefore as Kim teaches alginate in an amount of 2.5 wt.%, which is merely close to the claimed amount of at least 3%, the claimed range is prima facie obvious.
Next, Kim teaches agar in an amount from between 1% to 3% may be used ([0039]). As discussed previously, Kim teaches instead of agar, sodium alginate may be used ([0045]), and therefore teaches alginate in an amount from between 1% to 3%. The range taught by the prior art overlaps the claimed range and is therefore prima facie obvious.
On page 8, the Applicant further argues that the specific description of alginate in Kim is only in an amount of 0.05-0.15 wt.% or an amount of 0.05-0.10 wt.%, and at no point does Kim provide any teaching or suggestion of alginate in an amount of between 3% to 10%. The Examiner does not find this to be persuasive.
The ranges of alginate recited in Kim are when both agar and alginate are present, and it would be obvious to one of ordinary skill in the art that these ranges taught of alginate are applicable when agar is also present at the specified amount. Further, Kim explicitly teaches that instead of agar, gums such as pectin, sodium alginate, carrageenan, gelatin, or guar gum may be used ([0045]). It would be obvious to one of ordinary skill in the art when using sodium alginate instead of agar, the amount of the gum in the bead would not change, and thus the wt.% of sodium alginate would be the same as that taught for agar. This is merely simple substitution of one known type of gum in an aerosol generating bead for another known type of gum in an aerosol generating bead to yield the predictable result of a bead that generates an aerosol when heated.
The Applicant further argues on page 8 that the Final Office Action does not explain why the person of ordinary skill in the art would have been motivated to select alginate alone in a cross-linked polymer matrix while simultaneously maintaining the polyhydric alcohol content wt.% and the water content wt.%. The Examiner does not find this to be persuasive.
As discussed previously, Kim explicitly teaches other gums, such as sodium alginate, may be used instead of agar. Therefore, this is merely simple substitution of agar for sodium alginate, and the content of all other materials would not change including the polyhydric alcohol content and the water content.
On page 8, the Applicant further argues Kim does not teach cross-linking behavior at elevated polyhydric alcohol levels, bead self-support under heating, or release behavior under heating, and Besso does not address high glycerol loadings or reduced alcohol content. The Applicant further argues that the rejections rely on impermissible hindsight rather than on a teaching that the claimed property could be achieved using alginate alone in a bead configuration. The Examiner does not find this to be persuasive.
First, it is noted that the claimed property upon which applicant relies (i.e., cross-linking behavior at elevated polyhydric alcohol levels, bead self-support under heating, or release behavior under heating) 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). Next, it appears the Applicant is again arguing the selection of using alginate alone, which the Examiner has already addressed in previous arguments.
On page 9, the Applicant further argues that the rejections do not address the criticality of the claimed ranges in combination. The Examiner does not find this to be persuasive. The Applicant has not shown the criticality of the range, and the burden is on the Applicant to do so. Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP §2144.05.III.A.
On page 9, the Applicant argues that Kenichi describes capsule shells enclosing a liquid or semi-liquid core, whereas the Applicant’s claims recite beads lacking a discrete shell, and states the rejections do not explain why dimensional or ovality considerations developed for crushable capsules would be applicable to a thermally activated bead formed from a cross-linked polymer matrix. The Examiner does not find this to be persuasive.
Kim is silent to the dimensions and the ovality of the beads. As such 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 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, such as Kenichi which also teaches beads for use in an aerosol generating article.
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, 16-20 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 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 10 wt.% to 80 wt.% based on a total weight of the aerosol-generating element ([0039]: glycerin). The range taught by the prior art overlaps the claim 14 range of at least 30 percent and the claim 17 range of at least 60 percent and is therefore prima facie obvious.
And water in an amount of 10 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.
Kim does not appear to disclose (I) wherein the one or more matrix-forming polymers consists of alginate and wherein the aerosol-generating element comprises from about 3 percent by weight to about 10 percent by weight of alginate, (II) wherein the aerosol-generating element comprises less than about 20 percent by weight of water, (III) wherein the solid continuous matrix structure is a cross-linked polymer matrix, (IV) wherein the aerosol-generating element has an equivalent diameters of at least about 0.5 millimeter and (IV) wherein the aerosol-generating element has an ovality from about 2 percent to about 30 percent.
In regard to (I), Kim further teaches sodium alginate may be used instead of the agar ([0045]).
Therefore it would be obvious for one having ordinary skill in the art to substitute the agar with sodium alginate as taught by Kim, as Kim teaches sodium alginate may be used instead of agar, and this merely involves simple substitution of one known type of gum in an aerosol generating bead for another known type of gum in an aerosol generating bead to yield the predictable result of a bead that generates an aerosol when heated. As Kim teaches agar present in an amount of 3 wt.% ([0039]), simple substitution with sodium alginate would result in alginate present is an amount of 3 wt.%. The range taught by the prior art overlaps the claimed range of from about 3 percent to about 10 percent and is therefore prima facie obvious.
In regard to (II), Kim further teaches the ratio of agar, glycerin and water is not limited to that described above and can be applied according to various composition ratios [0039].
Kim further teaches water in an amount of 7.5 wt% to 37.5 wt%.
Therefore it would be obvious to one having ordinary skill in the art to modify the ratio of water to be between 7.5 wt.% and 37.5 wt% as taught by another embodiment of Kim, as Kim teaches the ratio of water is not limited and can be applied according to various composition ration, Kim teaches another water composition ratio, and this merely involves discovering optimum or workable ranges by routine experimentation. The range taught by the prior art overlaps the claimed range of less than about 20 percent by weight of water and is therefore prima facie obvious.
In regard to (III), 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 (IV), Kim further teaches the article can be manufactured in the shape of a sphere having a predetermined diameter…alternatively in an oval, droplet shape, etc. ([0037]).
Kim is silent to the equivalent diameter of the aerosol-generating element.
However, 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 (V), Kenichi further 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, as modified Kim teaches the solid continuous structure is 3 wt.% of the bead ([0039]: amount of agar), the remainder 97% is the aerosol-generating formulation dispersed within the solid continuous matrix structure. The range taught by the prior art falls within the claimed range of at least 80 percent by weight of the total weight of the aerosol-generating element.
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).
Regarding claim 28, Kim does not appear to disclose wherein when the aerosol-generating element is heated to a temperature in a range from about 150 degrees Celsius to about 350 degrees Celsius, and heat is supplied until no additional weight loss is detected, a residual weight of the aerosol-generating element is less than 120 percent of a weight of the solid continuous matrix structure.
However, the Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim, and that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See MPEP §§ 2114 and 2173.05(g).
Therefore as Kim teaches a structurally equivalent aerosol-generating element that may be operated as claimed, the claimed manner of operating the aerosol-generating element does not differentiate the aerosol-generating element from the prior art.
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
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.
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/N.A.S./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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