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 1-3, 5, 10, 12, 14, 20, 21, 24, 28, 30, 34-38, 40 and 43-49 are pending.
Claims 4 and 6-8 have been canceled.
Claims 1, 5, 14, 21, 24, 30 and 36 have been amended.
Claims 46-49 are new.
Response to Arguments
Applicant's arguments filed 12/8/2025 have been fully considered but they are not persuasive.
The Applicant argues that Tanaka describes that guar gum may be present only if carrageenan, agar or gellan gum is also present. The Applicant argues that Tanaka describes that the presence of carrageenan, agar, or gellan gum is critical because these gelling agents show the specific thermal behavior which is required for trapping menthol in the Tanaka invention (i.e., the ability to form a gel upon cooling from a temperature of 60 to 90 0C to a temperature of 0 to 40 °C). In contrast, the Applicant argues, the gelling agent recited in amended claims 1, 21, and 36 does not recite carrageenan, agar or gellan gum. Rather, the Applicant argues, Tanaka is very specific to certain polysaccharide gelling agents that show very specific thermal behavior, a person of ordinary skill in the art would not have expected to be able to entrap flavorant comprising menthol at high concentrations in amorphous solids based on different gelling agents to those discussed in Tanaka. There is no discussion in Tanaka, Campitelli or Fernando of the thermal properties of any gelling agents covered by the definition in amended claims 1, 21 and 36, let alone any suggestion that they would undergo the specific phase transformations upon cooling from 60-900C to 0-400C that Tanaka describes are necessary in order to entrap menthol at high concentrations within the flavor-containing sheets therein.
The Examiner respectfully disagrees. The independent claims do require a gelling agent, wherein the gelling agent consists of one or more compounds selected from the group consisting of alginates, pectins, cellulosic gelling agents and guar gum. However, the independent claims do not exclude other gelling agents from the sheet of aerosol-generating material.
The Applicant argues that Fernando and Campitelli relate to the technical field of heated aerosol generating devices (in which aerosol is generated in use by heating materials without combustion) and aerosol generating materials therefore (see paragraph [0001] of Fernando and the discussion of heating to temperatures that prevent burning on page 50, lines 11-13 of Campitelli). In contrast, the Applicant argues that Tanaka relates to methods for producing materials for use in traditional combustible smoking articles, such as traditional cigarettes (see the reference to cigarettes in paragraph [0017] and claim 9 of Tanaka). The Applicant argues that the requirements of materials for use in heated smoking articles (which are heated without combustion in use to generate an inhalable aerosol at a relatively low temperature) are also completely different to the requirements for materials for use in combustible smoking articles in which the materials are heated to much higher combustion temperatures in use.
The Examiner respectfully disagrees. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, all the references are directed to smoking articles.
The Applicant argues that, based on Tanaka, whether taken alone or in combination with Fernando or Campitelli, a person of ordinary skill in the art would not have assumed that the gelling agents recited in amended claims 5 and 30 are suitable for entrapping flavorants comprising menthol at high concentrations within an aerosol generating material. Thus, the Applicant argues, any combination of Fernando, Tanaka and Campitelli or Tanaka and Campitelli, would not have led a person of ordinary skill in the art to an amorphous solid as defined in amended claims 1, 21 and 36 that includes a relatively high amount of menthol flavorant of (from 10-80 wt% on a dry weight basis) and one or more gelling agents selected from the list in amended claims 5 and 30 (which display different thermal behaviour to the polysaccharides required by Tanaka).
The Examiner respectfully disagrees. Claims 5 and 30 list guar gum which is taught by modified Fernando, which teaches that the gelling agent consists of guar gum (Tanaka, guar gum and others listed in [0055] for "polysaccharide").
The Applicant argues that Strickland relates to yet another different technical field of materials for use in so called "smokeless" tobacco products that are consumed orally in a manner that does not typically involve any aerosol production. For example, the Applicant argues, paragraphs [0003], [0023], and [0036] of Strickland explain that the compositions therein are "orally disintegrable" as well as paragraph [0037], which discloses sizing the compositions/films to fit in the mouth as individual servings. The Applicant argues that the requirements for materials for use in "smokeless" tobacco products that are not typically consumed in a matter that involves aerosol generation are completely different to the requirements for materials for use in heated smoking articles, which in turn are completely different to the requirements of materials for use in combustible smoking articles.
The Examiner respectfully disagrees. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Strickland teaches a tobacco composition with a gelling agent comprising one or more of a calcium-crosslinked alginate and a calcium-crosslinked pectin (cross-linking agent is calcium ions for alginates and low methoxy pectins, [0228]). Thus, Strickland is brought in to teach a specific type of gelling agent that is applicable to a tobacco composition.
Regarding the argument that a person of ordinary skill in the art would not have "modified Fernando to incorporate the teachings of Strickland" or "modified Tanaka to incorporate the teachings of Strickland" (as alleged by the Examiner in the third paragraph of page 14, or the third paragraph on page 15, of the Office Action) as each of Fernando and Campitelli, Tanaka, and Strickland relate to different technical fields.
The Examiner respectfully disagrees. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 1-3, 5, 10, 12, 14, 36-38, 40, 43-45 and 48 are rejected under 35 U.S.C. 103 as
being unpatentable over Fernando et al. (US 2015/0359264) in view of Tanaka (US
2013/0319430) and Campitelli et al. (WO 2020/127116).
Regarding claim 1, Fernando discloses a consumable for use with a non- combustible aerosol provision system (Figure 5, aerosol generating article 10, [0118]), the consumable comprising: a sheet of aerosol-generating material comprising an amorphous solid (Figure 5,
aerosol forming substrate 20, [0118]), wherein the sheet of aerosol-generating material is crimped and gathered (Figure 5, aerosol-forming substrate 20 comprises a gathered sheet of crimped homogenized tobacco material, [0118]); and the consumable comprising a wrapper that circumscribes the aerosol-generating material (Figure 5, outer wrapper 60, [0121]).
Fernando fails to disclose wherein the amorphous solid comprises 10-80 wt.% of a flavorant comprising menthol calculated on a dry weight basis or that the amorphous solid further comprises a gelling agent selected from the claimed group of gelling agents.
Tanaka teaches a similar flavor-containing sheet for a smoking article (abstract)
wherein the amorphous solid comprises 10-80 wt.% of a flavorant comprising menthol
calculated on a dry weight basis (menthol content after storage (i.e. drying) from 48- 63 wt.%, [0083], and menthol used as flavor (see [0020])). Tanaka also teaches that these sheets with high menthol content have high flavor content, high flavor yield, and a high post-storage flavor-retaining property [0018]. Tanaka further teaches that the amorphous solid comprises a gelling agent (Tanaka, guar gum and others listed in [0055] for "polysaccharide" and guar gum and others are listed in the as filed specification as a "gelling agents" on page 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Fernando to incorporate the teachings of Tanaka to use about 48-63 wt.% of menthol as a flavorant in the sheet because doing SO would give the sheet high flavor content, high flavor yield, and a high post-storage flavor-retaining property, as recognized by Tanaka [0018].
Modified Fernando also fails to explicitly disclose wherein the amorphous solid is crimped and gathered.
Campitelli teaches a porous medium loaded with gel (i.e. amorphous solid) that is
crimped and gathered (see page 12 lines 25-26 for gathering and page 2 lines 25-26 for crimped, the gel (i.e. amorphous solid) can be part of the crimping/gathering process by being added first). Campitelli also teaches that crimping of the sheet material improves the structure to allow passageways through the structure (page 20, lines 15-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have further modified Fernando to incorporate the teachings of Campitelli to crimp and gather the sheet and gel because doing so would improve the structure to allow passageways through the structure, as recognized by Campitelli (page 20 lines 15-16).
Regarding claim 2, modified Fernando teaches the consumable of claim 1, wherein the consumable comprises at least one support for supporting the sheet of aerosol generating material (Fernando, Figure 5, two supports, support element 30 and aerosol-cooling element 40, [0119]).
Regarding claim 3, modified Fernando teaches the consumable according to claim 2, wherein the at least one support is in the form of a carrier sheet (Fernando, Figure 5, aerosol-cooling element 40 comprises a crimped and gathered sheet of polylactic acid, [0134]).
Regarding claim 5, modified Fernando teaches the consumable according to claim 3, wherein the gelling agent consists of guar gum (Tanaka, guar gum and others listed in [0055] for "polysaccharide" and guar gum and others are listed in the as filed specification as a "gelling agents" on page 9).
Regarding claim 10, modified Fernando teaches the consumable according to claim 1, wherein the amorphous solid is a dried gel (Tanaka, drying procedure explained in [0095]).
Regarding claim 12, modified Fernando teaches the consumable according to claim 1, wherein the amorphous solid comprises 1 - 60 wt.% of a filler (Fernando, between 1-5% non-tobacco fibers, [0191], see [0189] of Fernando for list of fibers and page 18 of the as-filed specification lists the filler can be fibrous).
Regarding claim 14, modified Fernando teaches the consumable according to claim 1, wherein the amorphous solid and excludes tobacco material (Tanaka, [0054] does not mention tobacco in composition).
Regarding claim 36, Fernando teaches a method of manufacturing a consumable for use with a non-combustible aerosol provision system, the method comprising:
providing a sheet of aerosol-generating material comprising an amorphous solid (homogenized tobacco sheets are formed, [0182]); crimping the sheet of aerosol-generating material (homogenized tobacco sheets are also crimped, [0183]); gathering the sheet of aerosol-generating material to form a gathered sheet of aerosol-generating material (homogenized tobacco material is gathered, [0182]); and circumscribing the gathered sheet of aerosol-generating material with a wrapper (a gathered crimped sheet of homogenized tobacco material is circumscribed by a wrapper, [0185]).
Fernando fails to disclose wherein the amorphous solid comprises 10-80 wt.% of a flavorant comprising menthol calculated on a dry weight basis.
Tanaka teaches a similar flavor-containing sheet for a smoking article (abstract) wherein the amorphous solid comprises 10-80 wt.% of a flavorant comprising menthol calculated on a dry weight basis (menthol content after storage (i.e. drying) from 48- 63 wt.%, [0083], and menthol used as flavor (see [0020])). Tanaka also teaches that these sheets with high menthol content have high flavor content, high flavor yield, and a high post-storage flavor-retaining property [0018]. Tanaka further teaches that the amorphous solid comprises a gelling agent (Tanaka, guar gum and others listed in [0055] for "polysaccharide" and guar gum and others are listed in the as filed specification as a "gelling agents" on page 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Fernando to incorporate the teachings of Tanaka to use about 48-63 wt.% of menthol as a flavorant in the sheet because doing SO would give the sheet high flavor content, high flavor yield, and a high post-storage flavor-retaining property, as recognized by Tanaka [0018].
Fernando also fails to explicitly disclose wherein the amorphous solid is crimped and gathered.
Campitelli teaches a porous medium loaded with gel (i.e. amorphous solid) that is
crimped and gathered (see page 12 lines 25-26 for gathering and page 2 lines 25-26 for crimped, the gel (i.e. amorphous solid) can be part of the crimping/gathering process by being added first). Campitelli also teaches that crimping of the sheet material improves the structure to allow passageways through the structure (page 20 lines 15-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have further modified Fernando to
incorporate the teachings of Campitelli to crimp and gather the sheet and gel because
doing so would improve the structure to allow passageways through the structure, as
recognized by Campitelli (page 20 lines 15-16).
Regarding claim 37, modified Fernando teaches the method according to claim
36, comprising providing at least one support for supporting the sheet of aerosol- generating material (Fernando, Figure 5, two supports, support element 30 and aerosol-cooling element 40, [0119]).
Regarding claim 38, modified Fernando teaches the method according to claim 37, comprising crimping the at least one support (Fernando, Figure 5, aerosol-cooling element 40 comprises a crimped and gathered sheet of polylactic acid, [0134]).
Regarding claim 40, modified Fernando teaches the method according to claim 36, wherein the method comprises casting the slurry of aerosol-generating material onto the at least one support (Fernando, aerosol-forming substrate may be in the form of a slurry and deposited (i.e., "cast") onto the thermally stable carrier (the support), [0219]).
Regarding claim 43, modified Fernando teaches a consumable manufactured by
the method as described in claim 36 (see rejection for claim 36 above). Claim 43 is a product-by-process claim, and the product (i.e., structure) is met as set forth above, therefore the method (process) of making that product is also met (see MPEP 2113).
Regarding claim 44, modified Fernando teaches a non-combustible aerosol provision system (Fernando, Figure 7, aerosol-generating device 110, [0126]) comprising a consumable according to claim 1 (see rejection for claim 1 above) and a non-combustible aerosol provision device (Fernando, Figure 6, aerosol-generating system 100, [0125]), the non-combustible aerosol provision device comprising an aerosol- generation device arranged to generate aerosol from the consumable when the consumable is used with the non-combustible aerosol provision device (Fernando, Figures 6 and 7, heating element 120 is inserted into aerosol-generating article 10 to heat it and form an aerosol, [0126]).
Regarding claim 45, modified Fernando teaches a method of generating aerosol from a consumable as described in claim 1, the method comprising heating the sheet of aerosol-generating material comprising the amorphous solid to generate aerosol from the consumable (see rejection for claims 1 and 44 above, and a user is easily envisioned to use that consumable in the non-combustible aerosol provision device to generate an aerosol through heating, also see abstract of Fernando).
Regarding claim 48, modified Fernando teaches that the aerosol generating material is optionally provided on a support, which means it may not be provided on a support (Fernando, [0219]).
Claims 21, 24, 28, 30, 35 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka (US 2013/0319430) in view of Campitelli et al. (WO 2020/127116).
Regarding claim 21, Tanaka discloses an aerosol-generating material comprising an amorphous solid (flavor-containing sheet for a smoking article which becomes a gel (i.e., amorphous solid), abstract), wherein the amorphous solid comprises 10-80 wt.% of a flavorant comprising menthol calculated on a dry weight basis (menthol content after storage (i.e. drying) from 48-63 wt.%, [0083], and menthol used as flavor (see [0020])). Tanaka further teaches that the amorphous solid comprises a gelling agent (Tanaka, guar gum and others listed in [0055] for "polysaccharide" and guar gum and others are listed in the as filed specification as a "gelling agents" on page 9).
Tanaka fails to explicitly disclose wherein the amorphous solid is crimped and gathered.
Campitelli teaches a porous medium loaded with gel (i.e. amorphous solid) that is crimped and gathered (see page 12 lines 25-26 for gathering and page 2 lines 25-26 for crimped, the gel (i.e. amorphous solid) can be part of the crimping/gathering process by being added first). Campitelli also teaches that crimping of the sheet material improves the structure to allow passageways through the structure (page 20 lines 15-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have further modified Fernando to incorporate the teachings of Campitelli to crimp and gather the sheet and gel because doing so would improve the structure to allow passageways through the structure, as recognized by Campitelli (page 20 lines 15-16).
Regarding claim 24, modified Tanaka teaches the aerosol-generating material according to claim 21, wherein the amorphous solid excludes tobacco material (Tanaka, [0054] does not mention tobacco in composition).
Regarding claim 28, modified Tanaka teaches the aerosol-generating material according to claim 24, wherein the amorphous solid is a dried gel (Tanaka, drying procedure explained in [0095]).
Regarding claim 30, modified Tanaka teaches the aerosol-generating material according to claim 21, wherein Tanaka teaches that the gelling agent is guar gum (Tanaka, guar gum and others listed in [0055] for "polysaccharide" and guar gum and others are listed in the as filed specification as a "gelling agents" on page 9).
Regarding claim 35, modified Fernando teaches the aerosol-generating material according to claim 21, wherein the amorphous solid comprises one or more of powdered botanical material, nicotine, and a tobacco extract (Tanaka, tobacco extract and/or natural plant flavors (botanical material) may be used in the sheet, [0042]).
Regarding claim 49, modified Fernando teaches that the aerosol-generating material is not provided on a support, specifically the amorphous solid (flavor-containing sheet) is “easily peeled off from a substate” (Tanaka, [0082]) and thus the aerosol-generating material is not provided on support.
Claims 20 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Fernando et al. (US 2015/0359264) in view of Tanaka (US 2013/0319430) and Campitelli et al.
(WO 2020/127116) as applied to claims 1 and 10, respectively, above, and further in view of Strickland et al. (US 2005/0244521).
Regarding claims 20 and 46, modified Fernando discloses the consumable according to claims 1 and 10, respectively, as set forth above. Modified Fernando fails to disclose wherein the gelling agent comprises one or more of a calcium-crosslinked alginate and a calcium-crosslinked pectin.
Strickland teaches a similar tobacco composition wherein the gelling agent comprises one or more of a calcium-crosslinked alginate and a calcium-crosslinked pectin (cross-linking agent is calcium ions for alginates and low methoxy pectins, [0228]). Strickland also teaches that the gel formed using in part calcium alginates or calcium pectins can provide a wide range of organoleptic characteristics and also the thickness of the gel encapsulant wall, which controlled the residence time of the gel beads in the solidifying solution [0225] and [0231].
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Fernando to incorporate the teachings of Strickland to have the gelling agent comprise either or both of a calcium-crosslinked alginate and a calcium-crosslinked pectin because doing SO would allow for a wide range of organoleptic characteristics and also the thickness of the gel encapsulant wall, which controlled the residence time of the gel beads in the solidifying solution, as recognized by Strickland [0225] and [0231].
Claim 34 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka
(US 2013/0319430) in view of Campitelli et al. (WO 2020/127116) as applied to claims
21 and 28, respectively, above, and further in view of Strickland et al. (US 2005/0244521).
Regarding claims 34 and 47, modified Tanaka discloses the consumable according to claims 21 and 28, respectively, as set forth above. Modified Tanaka fails to disclose wherein the gelling agent comprises one or more of a calcium-crosslinked alginate and a calcium-crosslinked pectin.
Strickland teaches a similar tobacco composition wherein the gelling agent comprises one or more of a calcium-crosslinked alginate and a calcium-crosslinked pectin (cross-linking agent is calcium ions for alginates and low methoxy pectins, [0228]). Strickland also teaches that the gel formed using in part calcium alginates or calcium pectins can provide a wide range of organoleptic characteristics and also the thickness of the gel encapsulant wall, which controlled the residence time of the gel beads in the solidifying solution [0225] and [0231].
Therefore, it would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Tanaka to incorporate the teachings of Strickland to have the gelling agent comprise either or both of a calcium- crosslinked alginate and a calcium-crosslinked pectin because doing so would allow for a wide range of organoleptic characteristics and also the thickness of the gel encapsulant wall, which controlled the residence time of the gel beads in the solidifying solution, as recognized by Strickland [0225] and [0231].
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 YANA B KRINKER whose telephone number is (571)270-7662. The examiner can normally be reached Monday, Wednesday, Thursday and Friday.
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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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YANA B. KRINKER
Examiner
Art Unit 1755
/YANA B KRINKER/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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