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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5-6-2026 and 5-18-2026 has been entered.
Response to Amendment
The office action is in response to Applicant’s arguments/remarks filed 5-6-2026.
Claim 1, 4-14, 16-17, and 23 are presently examined.
Claim 24 is canceled.
Claims 20 and 22 remain withdrawn.
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 1-5, 12-13, 17, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over John (WO2016120344A2), in view of Deevi (US5692291A), Hedge (US 4109664A), and Capelli (US20210015746A1).
Regarding Claim 1, John teaches a method of making an amorphous solid comprising:
(a) forming a slurry (see e.g., page 22 lines 12-28) comprising: -
0.5-60 wt% of a gelling agent (e.g., thickeners such as alginate, alginate 1-30%, page 22 line 24))
; and
5-80 wt% of an aerosol forming material (e.g., glycerol 10-60%, page 22 line 23);
0-60 wt% of an active constituent and/or flavorant (tobacco extract 0-50% an nicotine 0-4% for a total of 0-54%, see page 22 lines 25 and 26); wherein
these weights are calculated on a dry weight basis (page 22 line 21);
(b) shaping the slurry using a stencil (see page 16 line 10, stencil is disclosed and used to ensure a correct placement of the aerosol generating material, the slurry is placed into the stencil which shapes the aerosol forming material slurry);
(c) setting the slurry to form a gel (the aerosol generating material is in the form of a gel (page 22 line 17), and
(d) drying the gel to form an amorphous solid (see page 22 line 30, dried in an oven, see page 23 line 12, dried gel, a dried gel is an amorphous solid), wherein,
John is silent to the method including during (b) the slurry is shaped on a paper carrier however broadly teaches that the slurry is applied on a flat plate that may comprise any suitable heat conductive and heat-resistant material.
Deevi teaches the suitable carriers for tobacco flavor medium are created as tobacco fibers are wet laid and passed through a traditional paper making machine to form a paper like base web/mat 57 (column 8 lines 45-50) and that the slurry may be cast or extruded onto the base mat and tobacco flavor can also be supported on the carrier (see column 8 lines 55-67)
It would have been obvious to a person of ordinary skill in the art to modify John by shaping the slurry on Deevi’s paper base mat because a person of ordinary skill would recognize the paper base mat of Deevi is a known suitable carrier on which Johns slurry could be shaped with a reasonable expectation success.
Although John teaches thickening agents John and Deevi fails to explicitly disclose the thickening/gelling agent is a cellulosic gelling agent.
Hedge similarly teaches a method for producing a smoking material (column 1 lines 21-23) that includes a smoking material with a binder that includes a gelling (thickening) agent and teaches the suitable gelling agent is a cellulosic gelling agent and teaches this cellulosic gelling agent forms a gelling solution in water (column 1 lines 37-41) and teaches this formulation is reliable because it has good flexibility and produces a minimum of waste in processing during cigarette manufacture (column 2 lines 32-34).
Therefore, it would be obvious to modify the thickening agent of John with the thickening agent of Hedge because both John and Hedge are directed to methods for manufacturing smoking solid smoking materials, John teaches the smoking materials should include thickeners and Hedge teaches a cellulosic gelling agent or thickener that is reliable because it has good flexibility and produces a minimum of waste in processing during cigarette manufacture. Thus, it would have been obvious to a person of ordinary skill in the art before the filing date of the claimed invention to modify the thickening agent of John with the cellulosic gelling agent of Hedge, to include a thickener that is reliable because it has good flexibility and produces a minimum of waste in processing during cigarette manufacture.
John teaches the amorphous solid comprises nicotine as explained above (page 22 lines 25 and 26). However, John, Deevi and Hedge fail to explicitly disclose that the amorphous solid comprises an acid.
However, Capelli teaches a similar aerosol generating gel composition comprising nicotine and a carboxylic acid ([0129]-[0134] see examples in [0166]). Capelli also teaches that it was known in the art before the filing date of the claimed invention that adding a carboxylic acid to the composition is important to reduce variation of the alkaloid compound concentration in the composition during storage. [0129]. Accordingly, it would be oblivious to a person of ordinary skill in the art before the filing date of the claimed invention to modify John’s nicotine containing amorphous solid composition with an acid (such as a carboxylic acid like lactic acid [0129]) in order to improve the alkaloid compound stability (e.g., of the nicotine) and reduce variation in the alkaloid compound concentration in the composition of John during storage [0129].
Regarding Claim 2, John teaches the claim limitations as set forth above. Additionally, John teaches during (b), the slurry is shaped on a carrier (the carrier e.g., receptacle 57, as the slurry dries to a solid it is shaped in the stencil, see page 16 line 10 and claim 1)
Regarding Claim 3, John teaches the claim limitations as set forth above. Additionally, John teaches the slurry is shaped on an aluminum surface of the carrier (John teaches the receptacle is the carrier and can be aluminum, see page 7 lines 2).
Regarding Claim 4, John teaches the claim limitations as set forth above. Additionally, although not explicitly disclosed, it is commonly known in the art that the stencil would have to be removed and that it could be removed at any step (b), (c) or (d). (e.g., the stencil is not present in the final assembly for use so it necessarily has been removed at least after one of steps (b) through (d).)
Regarding Claim 5, John teaches the claim limitations as set forth above. Additionally, John teaches the stencil is shaped such that the method forms a plurality of discrete parts of amorphous solid (See FIG 2 plurality of recesses 7a, each containing amorphous solid), wherein
each part comprises aerosolizable components in amounts such that each part generates at least one puff of aerosol on heating (each part 7a contains aerosol generating material, see page 5 lines 24-26)
PNG
media_image1.png
457
725
media_image1.png
Greyscale
Regarding Claim 12, John teaches the drying removes 50-95 wt% of water in the slurry, calculated on a wet weight basis. Specifically, John teaches the percentage of water by weight goes from 40-90% by weight water to around 5%-40% weight water (page 23 lines 8-10). Thus, John teaches a removal of 0-94% by weight water, which overlaps with the claimed range of drying removes 50-95 wt% of water in the slurry, calculated on a wet weight basis. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding Claim 13, John teaches the resulting amorphous solid comprises from about 1 wt% to about 15 wt% water, calculated on a wet weight basis. Specifically, as explained in claim 12, John teaches the percentage of water by weight goes from 40-90% by weight water to around 5%-40% weight water (page 23 lines 8-10). Thus, John teaches the percentage per weight of the dried aerosol ranges from 5% to 90% on a wet weight basis, which overlaps with the claimed range. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding Claim 17, John teaches the claim limitations as set forth above. Additionally, John teaches the slurry comprises 10-60 wt% of the active constituent (nicotine) and/or flavorant (tobacco extract) (see page 22 lines 25-26, 0-54% nicotine and tobacco extract, which overlaps with the claimed range. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding Claim 23, John teaches the claim limitations as set forth above. Additionally, John teaches the stencil is removed before step (d). (e.g., see page 16 line 10, stencil is disclosed and used to ensure a correct placement of the aerosol generating material, the slurry is placed using the stencil which shapes the aerosol forming material slurry. It would be obvious to a person of ordinary skill in the art that the stencil which ensures correct placement of the aerosol generating material is removed after ensuring correct placement of the aerosol generating material, which is prior to step (d) (drying to an amorphous solid);
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over John (WO2016120344A2) and Deevi (US5692291A) and Hedge (US 4109664A) and Capelli (US20210015746A1) as applied to claim 1 above, and further in view of Fuisz (US20090095313A1).
Regarding Claim 6, John teaches the claim limitations as set forth above. However, although John teaches a stencil as set forth above, John fails to explicitly disclose the surfaces of the stencil which contact the slurry are formed from a non-stick material.
However, Fuisz teaches a related method of manufacture of reconstituted tobacco and teaches that the surfaces of manufacturing materials can become tacky causing the reconstituted tobacco to stick to the manufacturing materials, Fuisz teaches its necessary to include a nonstick surface (e.g., siliconized) on manufacturing materials that come into contact with tobacco products to prevent sticking [0102]. Therefore, it would be obvious to modify the stencils of John with the nonstick surfaces taught by Fuisz to prevent sticking, thus the combination of John modified by Fuisz teaches the stencil which contact the slurry are formed from a non-stick material.
Regarding Claim 7, modified John teaches the claim limitations as set forth above. Additionally, Fuisz teaches the surfaces of the stencil which contact the slurry are formed from silicone (e.g., siliconized, [0102], see also rejection of claim 6 above).
Regarding Claim 8, modified John teaches the claim limitations as set forth above. Additionally, Fuisz teaches the surfaces of the stencil which contact the slurry are coated with a release material (nonstick siliconized substrate is interpreted as a release material [0102]).
Fuisz teaches a related method of manufacture of reconstituted tobacco and teaches that the surfaces of manufacturing materials can become tacky causing the reconstituted tobacco to stick to the manufacturing materials, Fuisz teaches its necessary to include a nonstick surface (e.g., siliconized) on manufacturing materials that come into contact with tobacco products to prevent sticking [0102]. Therefore, it would be obvious to modify the stencils of John with the nonstick surfaces taught by Fuisz to prevent sticking, thus the combination of John modified by Fuisz teaches the stencil which contact the slurry are formed from a non-stick material.
Regarding Claim 9, modified John teaches the claim limitations as set forth above. Additionally, John teaches the release material is an amphoteric material. Specifically, John teaches the stencil can aluminum (see page 7 lines 2) and its commonly known in the art that the surface of aluminum oxidizes to aluminum oxide and oxides such as aluminum oxide are commonly known to be amphoteric.
Regarding Claim 10, modified John teaches the claim limitations as set forth above.
Fuisz teaches a related method of manufacture of reconstituted tobacco and teaches that the surfaces of manufacturing materials can become tacky causing the reconstituted tobacco to stick to the manufacturing materials, Fuisz teaches its necessary to include a nonstick surface (e.g., siliconized) on manufacturing materials that come into contact with tobacco products to prevent sticking [0102]. Therefore, it would be obvious to modify the stencils of John with the nonstick surfaces taught by Fuisz to prevent sticking, thus the combination of John modified by Fuisz teaches the stencil which contact the slurry are formed from a non-stick material.
Additionally, Fuisz teaches setting the slurry comprises adding a setting agent to the slurry. Specifically, Fuisz teaches a thermoplastic polymer can be used as a setting agent, its commonly known in the art that a thermoplastic polymer will harden as it cools and this agent that hardens while cooling is interpreted as a setting agent. (See manufacturing example D, [0140]-[0144], HPC LF 55.75, this example compound is a hydroxypropylcellulose (HPC). HPC’s are commonly known water-soluble cellulose esters with thermoplastic properties. HPC Thermoplastics are commonly known and used as setting agents or agents which cause hardening or setting upon cooling.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over John (WO2016120344A2), Deevi (US5692291A), Hedge (US 4109664A), Capelli (US20210015746A1), and Fuisz (US20090095313A1) as applied to claim 10 above, and further in view of Mishra (US20060144412A1).
Regarding Claim 11, modified John teaches the claim limitations as set forth above. However, John and Fuisz are silent to the setting agent comprises calcium.
Mishra teaches a tobacco formulation with a setting agent that comprises calcium. Specifically Mishra teaches encapsulation or setting can include cross linking polymers by creating crosslinking salt bridges in the polymer by employing multivalent cations (e.g., calcium from calcium salts) as the crosslinking agent (see [0027]-[0029]). Mishra teaches compounds of varying harnesses and solubilities can be formed depending on reaction time/concentration, (e.g., compounds in a range of harnesses from gels to solids [0030]). Mishra teaches that this process resistant to degradation and heat [0018].
Therefore, it would be obvious for a person of ordinary skill in the art to modify the method of John with the composition of Mishra so that the setting agent comprises calcium so that it can be resistant to degradation and heat.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over John (WO2016120344A2), Deevi (US5692291A), Hedge (US 4109664A), and Capelli (US20210015746A1), as applied to claim 1 above, and in further view of John2 (KR20160071458A1), English machine translation relied upon.
Regarding Claim 14, modified John teaches the claim limitations as set forth above. However, John is silent to during the shaping, a depth of the slurry in the stencil is less than about 4mm. John is further silent to the depth or thickness of the slurry or stencil.
Thus, a person of ordinary skill in the art would have been motivated to search the known art for suitable thicknesses or depths of a slurry that would be suitable for a tobacco slurry in a stencil. John2 teaches forming a tobacco slurry that is evenly poured for casting to a suitable thickness or depth of 0.9 mm to 2 mm (page 16 paragraph 6), which falls within the claimed range of less than about 4mm. John2 also teaches it may be advantageous for the heating element to have a large surface area to volume ratio to promote heating of the aerosol generating material and to avoid loss of thermal energy. Thus a person of ordinary skill in the art would have been motivated to modify the method of John with the slurry depth of John2 to have a large surface area to volume ratio and to promote heating of the aerosol generating material and to avoid loss of thermal energy.
Regarding Claim 16, modified John teaches the claim limitations as set forth above. John teaches drying but fails to explicitly disclose how much the drying will decrease the thickness of the resulting solid.
However, John2 teaches the water will reduce from 0-94% as set forth above. Thus starting with a slurry thickness of 2mm, a volume reduction due to waterloss of a slurry is commonly known in the art, if we expect a minimal volume reduction of 50% and a maximal volume reduction of 89%, this would result in a final thickness of between 11% and 50% of the depth of the slurry in the stencil after drying which overlaps with the claimed range of the drying results in an amorphous solid which has a thickness that is between about 5% and 20% of the depth of the slurry in the stencil. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Response to Arguments
Applicant’s arguments, see arguments and claim amendments, filed 5-6-2026, with respect to the rejection(s) of claim(s) 1, 4-14, 16-17, and 23 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of John, Deevi, Hedge, and Capelli as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael T Fulton whose telephone number is (703)756-1998. The examiner can normally be reached Monday-Friday 7:00 - 4:30 ET.
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, Michael H Wilson can be reached on 571-270-3882. 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.
/M.T.F./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
Prosecution Insights