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
This office action is in response to Applicant’s amendment filed on 29 June 2026:
Claims 1-7, 9-13, 15, 17, 19, 21-22, 24-25, 28-29, 32-33 and 35 are pending
Claims 22, 24-25, 28-29, 32-33 and 35 are withdrawn
Claims 1 is amended
Claims 8, 14, 16, 18, 20, 23, 26-27, 30-31 and 34 are cancelled
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 June 2026 has been entered.
Response to Amendment
Applicant's amendments to the claims filed 29 June 2026 have been acknowledged.
Response to Arguments
Applicant’s arguments filed 29 June 2026, with respect to the rejection of Claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive.
On Pages 7-9 of Applicant’s Remarks, Applicant has amended Claim 1 to further recite the volatile component is predominantly present on the aerosol generating material’s surface “such that the distribution of the volatile component is not homogeneous”. Applicant argues that there is no motivation to modify Plattner’s aerosol generating material to be non-homogenous because Plattner specifically aims for a homogenized material to achieve high stability and quality foam material. Thus, it would not be reasonable to modify Plattner such that their product loses its homogeneity as that is the primary goal of Plattner’s invention.
Examiner has reviewed and agree with the Applicant’s arguments and therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Franke et al (Publication No. US20200163377A1).
Claim Interpretation
An interpretation of Claim 1 will be made for the following claim limitation: “the volatile component is applied to the surface of the agglomerated structure in liquid form such that the volatile component is predominantly present on the surface of the aerosol generating material, and such that the distribution of the volatile component is not homogeneous.”
It is noted that the Applicant’s Specification primarily discusses the homogenized distribution of the volatile component, providing examples such as the inclusion of the volatile component before or after an extrusion step for material preparation (see Pg. 9, Lines 8-13). Regarding the alternative non-homogenous distribution recited in amended Claim 1, Applicant’s disclosure simply mentions that it is an alternative choice but lacks details or specific explanation on how exactly this is achieved, and/or provide example embodiments wherein such a distribution is achieved.
It appears that regarding the non-homogenous volatile component distribution (see Applicant’s Specification, Pg. 9, Lines 13-15), the Applicant is specifically relating it to the application of the volatile component on the particle surface, which is performed through methods such as spraying or partial immersion (Pg. 8, Lines 18-21). As such, it seems the implication is that surface application via spraying or partial immersion would meet the requirement of a non-homogenous volatile component distribution since the distribution is predominately on the surface in comparison to the core.
For examination purposes, Examiner will interpret the recitation of “such that the distribution of the volatile component is not homogeneous” to be fulfilled if the prior limitation of said component being “predominately present on the surface of the aerosol generating material” which can be subsequently achieved via spraying or partial immersion methods.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9-13, 15, 17, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Franke et al (Publication No. US20200163377A1) in view of Hufnagel et al (Publication No. US20160286851A1), as evidenced by Heck et al (A Review and Assessment of Menthol Employed as a Cigarette Flavoring Ingredient, see attached copy), and National Center for Biotechnology Information (PubChem Compound Summary for Nicotine, see attached copy).
Regarding Claim 1, Franke discloses an aerosol generating material (Abstract, [004]; tobacco constituent releasing component) comprising:
particles (i.e., tobacco particles) containing an active substance (i.e., nicotine) ([0042]; discloses that the tobacco particles contain nicotine, which is considered to be an active substance);
and a volatile component ([0072, 0096, 0107]; the constituent component is disclosed to contain vaporizable flavour (i.e., menthol), which are considered equivalent to the volatile component);
wherein the aerosol generating material (i.e., constituent releasing component) has an agglomerated structure comprising the tobacco particles comprising the active substance (i.e., nicotine) [0004, 0042];
Plattner does not explicitly disclose the following:
wherein the volatile component is incorporated into the aerosol generating material in liquid form;
wherein the liquid volatile component is applied to the surface of the agglomerated structure;
such that the volatile component is predominantly present on the surface of the aerosol generating material, such that the distribution of the volatile component is not homogeneous;
wherein the volatile component has a vapor pressure at 20°C which is greater than or equal to the vapor pressure of the active substance at 20°C;
and wherein the release of the active substance from the aerosol generating material is controlled by competition with the release of the volatile component.
Regarding (I-II), Hufnagel, directed to a smoking composition, discloses an aerosol-forming substrate/material and a flavour precursor compound ([Abstract, 0072]; discloses that the flavor compound is considered as a volatile substance). The aerosol-forming substrate can comprise of extruded homogenized tobacco such as agglomerated particulate tobacco (i.e., agglomerated structure) and the flavour precursor compound, wherein the flavor precursor can be applied to said agglomerated tobacco substrate by spraying the substrate with the flavor precursor in a liquid carrier (i.e., liquid form) [0047, 0051].
Though Hufnagel does not explicitly state that the volatile/flavor component is applied to the surface of the agglomerated tobacco substrate structure, one ordinarily skilled in the art would understand that when a liquid is sprayed on a material, the sprayed liquid will be disposed (i.e., applied) on the substrate surface that is exposed to the sprayed liquid.
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention, to take the agglomerated aerosol-generating material structure and volatile flavor component disclosed by Franke, and apply the volatile flavor component to a surface of the aerosol-generating material structure in a liquid form by spraying the volatile flavor component as disclosed by Hufnagel, as both are directed to an agglomerated tobacco aerosol-generating material, where this applies a known liquid application technique (i.e., spraying) to a similar material (i.e., tobacco substrate) to predictably yield an aerosol-generating material that has liquid volatile flavor component applied to its surface.
Regarding (III), it should be noted that Applicant’s Specification states that the porosity of the agglomerated structure can be adjusted based on the size of the particles depending on said structure’s intended use, further discussing how particle sizes can be selected to make a more porous agglomerated structure (see Page 12, Lines 1-15). This would indicate that Applicant’s agglomerated structure can be a similarly open pore (i.e., porous) material as the one disclosed by Plattner.
Furthermore, Applicant also explicitly discloses that by spraying a liquid volatile component unto the aerosol generating material (i.e., the porous agglomerated structure) (Page 8, Lines 18-20), this will result in said volatile component being predominantly present on the surface of the aerosol generating material (Page 9, Line 1). Since the presence of the volatile component is predominately located on the surface without penetrating into the rest of the agglomerated structure which has no volatile component, said volatile component’s distribution is considered non-homogenous.
In this regard, Franke also discloses that the agglomerated structure of the constituent releasing component can be a porous agglomerated structure by adjusting the size of the tobacco particles used to make said agglomerated structure [0060]. In particular, Franke also notes that the flavour-modifier may either be incorporated into the precursor composition prior to forming the agglomerated structure, or applied once the agglomerated structure has been formed [0072].
As such, if one ordinarily skilled in the art were to alternatively apply the liquid volatile component after the structure is formed as disclosed by Franke, using the spraying method disclosed by Hufnagel (see rejection above), then there is a reasonable expectation as detailed in Applicant’s specification that the volatile component will predominately be disposed on the surface of the agglomerated structure and thus, have a non-homogeneous volatile component distribution.
Therefore, one ordinarily skilled in the art would reasonably expect that if the Applicant’s agglomerated structure is a similar porous (i.e., open pore) structure as Franke’s porous agglomerated structure, then there is a reasonable expectation that spraying a volatile component as taught by Hufnagel on similar structures will also similarly result in said component being predominantly applied on said structures’ surface and resulting in a non-homogenous volatile component distribution (i.e., not present throughout the structure) unless evidence of the contrary is provided.
Regarding (IV), it should be noted that when the composition recited in the reference is substantially identical to that of the claim, claimed properties/functions are presumed to be inherent (see MPEP § 2112.01). In this case, Applicant discloses that nicotine is a suitable active substance (see Claim 3; Specification filed 27 October 2022, Pg. 9) and menthol is a suitable volatile component (see Claim 7, Specification filed 27 October 2022, Pg. 8).
As Franke also discloses the same composition (i.e., aerosol/constituent releasing material with nicotine and menthol), there is a reasonable expectation that Franke’s aerosol material (i.e., constituent releasing component) would have the same properties and function as the one claimed in Claim 1.
Furthermore, it is noted that menthol, as evidenced by Heck, has a vapor pressure of 0.8 mm Hg at 20 degrees Celsius, and nicotine, as evidenced by The National Center for Biotechnology Information (NCBI), regarding nicotine, has a vapor pressure of 0.006 kPa (0.05 mm Hg) at 20 degrees Celsius. Therefore, Franke’s disclosure satisfies the claim limitations.
Regarding (V), it is noted that the controlled release of the active substance is merely the intended result of the mixture of the active and volatile components. Given that Franke discloses the same components as those disclosed by the Applicant (see Claim 1 rejection above), it is expected that they have similar functions and act in the same way as claimed.
Regarding Claim 2, Franke further discloses that the aerosol generating material (i.e., tobacco constituent releasing component) is used with an aerosol provision system/device (Abstract).
Regarding Claim 3, Franke further discloses the active substance is nicotine (Abstract, [0042]; discloses that the agglomerated structure containing tobacco particles also contains nicotine).
Regarding Claim 4, Franke further discloses the particles comprising the active substance are tobacco particles ([0042]; discloses tobacco particles contain nicotine which is considered an active substance).
Regarding Claim 5, Franke discloses the aerosol material comprises menthol which has been identified by the Applicant as a suitable volatile component (see Claim 1 rejection). As such, it is expected that if the menthol disclosed by the Applicant meets the vapor pressure limitation, then the menthol disclosed by Franke must also satisfy the limitation.
This is further evidenced by Heck disclosing that menthol has a vapor pressure of 0.8 mm Hg at 20 degrees Celsius (i.e., 107 Pa) which satisfies the claim limitation.
Regarding Claim 6, Franke further discloses the volatile component is a volatile flavor ([0072]; menthol is considered a flavoring agent/modifier).
Regarding Claim 7, Franke further discloses the volatile component is menthol ([0072]; see Claims 1 and 6 rejection; menthol is identified as a volatile component).
Regarding Claim 9, Franke further discloses that pH of the aerosol generating material (i.e., foam mixture) has an adjusted pH value between 8 and 14 (Abstract, [0046-0047, 0049-0051]; the constituent releasing agglomerated structure is formed from a precursor composition that is pH adjusted with base solution).
The range for pH adjustment disclosed by Franke overlap with the claimed range disclosed by the Applicant (pH from 4 to 9.5) and are therefore considered prima facie obvious (see MPEP § 2144.05.I).
Regarding Claim 10, Franke further discloses the pH of the aerosol generating material (i.e., agglomerated constituent) is increased (i.e., adjusted) by the addition of one or more bases [0046].
Regarding Claim 11, Franke further discloses the one or more bases comprise of carbonates (i.e., sodium carbonate) and hydrogen carbonates (i.e., potassium hydrogen carbonate) [0006-0007].
Regarding Claim 12, Franke further discloses the particles comprising an active substance (i.e., tobacco particles which contain nicotine) have an average diameter no greater than 3 mm [0009].
Regarding Claim 13, Modified Franke further discloses the liquid volatile component comprises the volatile component and a solvent (see Claim 1 rejection for modifying Franke to have liquid volatile component applied via spraying per Hufnagel; Hufnagel, [0059]; discloses that the volatile component sprayed unto the structure is dissolved into a solvent to form a solution).
Regarding Claim 15, Franke further discloses that the aerosol generating material (i.e., constituent releasing component) further comprises one or more aerosol forming agents such as propylene glycol and glycerol [0010, 0071].
Regarding Claim 17, Franke further discloses the aerosol generating material further comprising one or more binder selected from a group consisting of thermoreversible gelling agents such as gelatin, starches, polysaccharides, pectins, alginates, celluloses, and cellulose derivatives such as carboxymethylcellulose [0068].
Regarding Claim 19, Franke further discloses the aerosol generating material (i.e., constituent releasing component), wherein a precursor composition comprising the particles comprising an active substance (i.e., nicotine) is extruded to form the agglomerated structure [0004, 0014, 0026].
Regarding Claim 21, Franke further discloses the aerosol generating material (i.e., agglomerated constituent releasing component) is in the form of granules [0015].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhuang et al (Publication No. US20220312830A1) – Method for preparing a nicotine-containing agglomerate using a fluid bed granulator. The agglomerate may further comprise binders and flavor compounds that can be sprayed onto the agglomerate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vu P Pham whose telephone number is (703)756-4515. The examiner can normally be reached M-Th (7:30AM-4:00PM EST).
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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.
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/V.P./Examiner, Art Unit 1755
/ERIC YAARY/Examiner, Art Unit 1755
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