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 .
Response to Arguments
Applicant’s amendments an arguments, filed 1/26/2026, have overcome the following rejections:
The indefiniteness rejection of claims 1-6, 8-13, 15 and 17-23 due to amending the claims to clarify them.
The rejection of Claims 1-2, 5-6, 9, 11-13 and 18 under 35 U.S.C. 102(a)(1) and under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bigot et al due to adding limitations neither found nor suggested in the cited prior art.
The rejections of process Claim 20 under 35 U.S.C. 103 over Aoun et al and Bigot et al due to adding process limitations neither found nor suggested in the cited prior art.
The rejection of Claims 1-2,6,9, 11-13, 15 and 18-23 under 35 U.S.C. 103 over White et al because White et al does not teach a dried composition comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material.
The indicated rejections have been withdrawn. The remaining rejections are maintained but have been modified to address the amendments to the claims.
Applicant’s arguments regarding the remaining rejections under 35 U.S.C. 103 as being obvious over White et al, Aoun et al and Bigot et al have been carefully considered, but they are not convincing.
Applicant discusses purported advantages of the claimed spray-dried or freeze-dried precursor material, the precursor material comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material and wherein the precursor material is in the form of a suspension or liquid. Applicant argues that :none of the cited references disclose, teach, suggest, or provide motivation for these features, and cannot be combined to arrive at the presently claimed invention. Applicant also argues that none of the cited references suggest the advantages described above.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”)
The claims are directed to a dried composition comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material. The claim terms “spray-dried or freeze-dried” are process related limitations. The precursor is subjected to a process that alters or destroys the starting precursor composition.
It is not clear what physical or chemical property is conferred to the final product, which is a dried composition comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material, by the physical state of the precursor composition and the method used to obtain the dried composition as opposed to the dried compositions comprising claimed components that are made by different processes as disclosed by the cited prior art. The claimed limitations appear to be related to method limitations that impart no patentable weight to the claim.
Regarding Aoun, Applicant argues that the extract is subsequently mixed with water to form a slurry and so, if dried, the extract will dissolve, so that the resultant aerosol generating material cannot be said to comprise a spray- dried or freeze-dried tobacco extract. Applicant further argues that freeze- or spray-drying would affect the amount of aerosol generating agent and therefore its properties, and it would be counterintuitive for a person of ordinary skill in the art to go against this teaching and to freeze/spray-dry the aerosol generating agent. Applicant also argues Aoun discloses that the slurry is "shaped" before drying, which indicates that the slurry cannot be a liquid or a suspension.
Aoun discloses a solid (reads on dried) aerosol generating material (precursor) including a tobacco extract and an aerosol generating agent (aerosol former). The open language of the claims permits additional components in the composition. The product of Aoun appears to be the same as or similar to the claimed product, a dried composition comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material, although produced by a different process.
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Regarding Bigot, Applicant argues that Bigot describes reconstituted tobacco in the form of a bulk solid comprising a plant extract, refined plant fibres and an aerosol-generating agent. The bulk solid may be formed by combining and moulding the listed components and then drying the solid mass. The bulk solid composition is not fully dried, and has a residual water content of 5 to 30%. In addition, the precursor material is explicitly a solid, as opposed to a suspension or liquid as recited.
The instant claims recite a water content of no more than about 5%, which touches or slightly overlays the range disclosed by Bigot. Bigot discloses a solid (reads on dried) aerosol generating material (precursor) including a tobacco extract and an aerosol generating agent (aerosol former). The open language of the claims permits additional components in the composition. The product of Bigot appears to be the same as or similar to the claimed product, a dried composition comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material, although produced by a different process.
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6,9-13,15, 17-19 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Aoun et al (US 2018/0279666)
Claims 1-2, 5-6, 9, 11-13 and 18: Aoun et al discloses a solid (reads on dried) aerosol generating material (precursor) including about 5-35 wt %, such as 10-20 wt % or at least about 10 wt % tobacco extract; about 50-80 wt % filler (excipient); about 10-35 wt % aerosol generating agent (aerosol former); and about 2.5-10 wt % binder (excipient); wherein weight percentage is calculated on a dry weight basis (Abs, [0007], [0027], [0032]). The disclosed ranges overlay the claimed ranges. The tobacco extract is an aqueous tobacco extract in some embodiments, wherein excess water is removed in some embodiments by spray-drying or freeze-drying [0033].
Disclosed aerosol generating agents include polyols such as sorbitol, glycerol, and glycols like propylene glycol or triethylene glycol . In some cases, the aerosol generating agent may comprise, substantially consist of, or consist of glycerol and/or propylene glycol. ([0012],[0046]).
The compositions disclosed comprise claimed ingredients in claimed amounts or, at least, it would have been obvious to one of ordinary skill in the art to select claimed ingredients in claimed amounts and form a dried aerosol generating material with a reasonable expectation of success.
The product of Aoun appears to be the same as or similar to the claimed product, a dried composition comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material, although produced by a different process.
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Regarding Claim 18, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Aoun et al discloses that a component for aerosol generation by electrical heating comprises the aerosol generating material described herein and an electrically resistive heating element [0065].
Claims 3-4 and 10: In some embodiments, the aerosol generating material comprise sone or more flavorants (excipients) [0060]. Disclosed flavorants include lactose, sucrose, sorbitol, mannitol, etc. [0061] or, at least, it would have been obvious to one of ordinary skill in the art to select claimed ingredients in claimed amounts and form a dried aerosol generating material with a reasonable expectation of success.
Claim 13: Aoun et al further discloses that the aqueous tobacco extract can contain tobacco solids in an amount from about 40% to about 95% on a wet weight basis (total weight including water) [0038]. In an example, the solids content of the tobacco extract was 41.1% ([0100], Example 1, Table 1). In another example, the solids content of the tobacco extract was 49.6% ([0112], Example 4, Table 5).
Claim 17: In an example, the dried aerosol generating material had a water content of 6.3% ([104]-[0107], Example 2, Table 2), which is considered to touch the claimed range of no more than about 5% or, at least, one of ordinary skill in the art would have found no significant difference between the water content of the dried aerosol generating material of Aoun et al and the claimed dried aerosol generating material.
Claim 19: Aoun et al discloses a device comprising an aerosol generating material as described herein and a heating means which volatilizes components in use to form an aerosol and/or gas.[0070]. In some embodiments, the heating means is an electrical heating means and results in no combustion or essentially no combustion of the aerosol generating material ([0071]-[0072]). Therefore, the device and inventive aerosol generating material comprise a non-combustible aerosol-provision system.
Claims 21-23: Aoun et al discloses conditioning the dried solid aerosol generating material in air with a relative humidity of about 50-80% ([0092], [0106], Example 1, [0117], Examples 5-17).
Claims 1-6,8-13,15,17-19 and 21-23 are rejected under 35 U.S.C. 103 as obvious over Bigot et al (US 2022/0053815). Bigot et al is a national stage application drawing priority to International Application PCT/EP2019/083736, filed 12/4/2019 and published as WO 2020/115166 on 6/11/2020 and claims priority to FR-1872395, filed 12/5/2018.
Claims 1-2, 5-6, 9, 11-13 and 18: Bigot et al discloses a bulk solid reconstituted plant composition suitable for devices that heat tobacco without burning it (aerosol provision system) (Abs). The bulk solid reconstituted plant composition comprises a plant extract, refined plant fibers and an aerosol-generating agent ([0008]-[0011], [0095]-[0096]).
The composition is made by drying a mixture of refined plant fibres, a plant extract and an aerosol-generating agent by hot-air drying or by freeze-drying ([0064]-[0067], [0074]). Advantageously, drying by freeze-drying makes it possible to easily preserve the shape of the moulded solid composition and not to degrade the aromatic chemical compounds or the chemical compounds which have therapeutic properties of the plant [0078]. Most particularly, the plant is the tobacco plant [0042], which reads on an active-containing plant material. The aerosol-generating agent is preferably glycerol (reads on an aerosol-former) [0035]. An advantageous composition is therefore a dried aerosol-generating material comprising freeze-dried precursor material comprising an active-containing plant material and aerosol-former material or, at least, forming the claimed composition would have been obvious to one of ordinary skill in the art to obtain the disclosed benefits.
In examples, a dried bulk solid reconstituted plant composition is produced comprising 28.4% aqueous tobacco extract, 17.9% glycerol and 53.7% fiber ([0102]-[0106], [0108], Table 1). The percentages lie within the claimed ranges.
More generally, the bulk solid reconstituted plant composition comprises:
5-75% of a plant extract, with specific percentages mentioned of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70% and 75% of a plant extract ([0029]-[0030]);
15-85% of refined plant fibers, with specific percentages mentioned of 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80% and 85% of refined plant fibers ([0022]-[0023]); and
5-50% of an aerosol-generating agent, with specific percentages mentioned of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% ([0036]-[0037]).
The disclosed ranges and examples include specific values that lie within or significantly overlay the claimed ranges. From the disclosure of Bigot et al, it would have been obvious to one of ordinary skill in the art to select claimed amounts of tobacco extract, refined tobacco fibers (tobacco solids) and aerosol generating agent and form the bulk solid reconstituted plant composition of Bigot et al with a reasonable expectation of success in obtaining a composition suitable for devices that heat tobacco without burning.
The product of Bigot appears to be the same as or similar to the claimed product, a dried composition comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material, although produced by a different process.
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Regarding Claim 18, Bigot et al discloses that the bulk solid reconstituted plant composition of the invention can be used in a device that heats tobacco without burning it. the term “device that heats tobacco without burning it” denotes any device which allows the formation of an aerosol intended to be inhaled by a consumer (reads on an aerosol provision system) ([0096]-[0097]).
Claims 3-4: Bigot et al discloses that the aerosol-generating agent can be sorbitol, glycerol, propylene glycol, triethylene glycol, lactic acid, glyceryl diacetate, glyceryl triacetate, triethyl citrate or isopropyl myristate, or a mixture thereof ([0034]-[0035]). Absent convincing evidence of unexpected results commensurate in scope with the claims, it would have been obvious to one of ordinary skill in the art to include sorbitol as an additional aerosol-generating agent along with glycerol in the bulk solid reconstituted plant composition of Bigot et al.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Sorbitol is also known in the art as a flavorant or sweetener, and is a claimed excipient.
Claim 8: bigot et al discloses that the bulk solid reconstituted plant composition can comprise the plant extract in amounts up to 45%, 50%, 55%, 60%, 65%, 70% or 75% ([0029]-[0030]). It would have been obvious to one of ordinary skill in the art to use an amount of tobacco extract in the claimed range in the bulk solid reconstituted plant composition of Bigot et al with a reasonable expectation of success in obtaining a composition suitable for devices that heat tobacco without burning.
Claim 10: As noted above, sorbitol is a claimed excipient and also disclosed by Bigot et al as aerosol-generating agent. Absent convincing evidence of unexpected results commensurate in scope with the claims, it would have been obvious to one of ordinary skill in the art to include a claimed amount of sorbitol as an additional aerosol-generating agent and an excipient along with glycerol in the bulk solid reconstituted plant composition of Bigot et al with a reasonable expectation of success in obtaining a composition suitable for devices that heat tobacco without burning.
Claim 15: Bigot et al discloses that those skilled in the art will know how to adjust the die of the mould in order to obtain a bulk solid composition, the shape (e.g.- granular) and volume (size) of which are adjusted to the device that heats tobacco without burning it [0072]. Therefore, the shape and size are revealed to be result effective variables that can be determined by one of ordinary skill in the art through routine experimentation.
Claim 17: Bigot et al discloses that the bulk solid composition of the invention can have a residual water content of 5% to 30% [0040], which slightly overlays the claimed range.
Claim 19: Since the bulk solid reconstituted plant composition of Bigot et al is suitable for devices that heat tobacco without burning (Abs,, [0095]), a non-combustible aerosol-provision system comprising the bulk solid reconstituted plant composition of Bigot et al would have been obvious as an intended system for use by a smoker.
Claims 21-23: Bigot et al does not disclose sealing the inventive aerosol generating material from contact with ambient atmosphere. Therefore, the inventive dried solid aerosol generating material is exposed to water from the ambient humidity. It is noted that the claims do not specify what level of humidity is intended by humid environment.
Allowable Subject Matter
Claim 20 is allowed over the prior art.
The following is an examiner’s statement of reasons for allowance: Aoun et al and bigot et al are the nearest prior art. The prior art fails to disclose or reasonably suggest a dried aerosol-generating material comprising a.spray-dried or freeze-dried precursor material, the precursor material comprising an extract from a flavor- and/or active-containing plant material and an aerosol former material and wherein the precursor material is in the form of a suspension or liquid.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 DENNIS R CORDRAY whose telephone number is (571)272-8244. The examiner can normally be reached Monday-Friday 8 AM-5 PM (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, Abbas Rashid can be reached at (571) 270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS R CORDRAY/Primary Examiner, Art Unit 1748