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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/2/2026 has been entered.
Response to Amendment
This office action is in response to Applicant’s amendment filed 3/2/2026.
Claim 1 is amended.
Claims 3, 21-22, 24-30, and 32 are cancelled.
Claim 33 is newly added.
Claims 1-2, 4-20, 23, 31, and 33 are pending. Claims 19-20, 23, and 31 have been withdrawn.
Response to Arguments
Applicant's arguments regarding amended claim 1 filed 3/2/2026 have been fully considered but they are not persuasive.
Applicant argues that while Rousseau may mention a reconstituted material that is nicotine free (citing [0052]), there is no teaching or suggestion that the nicotine-free reconstituted material comprises tobacco (p. 7). Applicant points to [0053] in Rousseau to show that the reconstituted plant material can be combined with tobacco material to provide desired nicotine levels and tobacco taste (p. 7). Applicant points to Examples 3 and 4 to show that Rousseau fails to disclose the nicotine content of these reconstituted material that comprises tobacco (p. 7).
The Examiner respectfully disagrees.
First, the Examiner contends that Rousseau teaches in a single paragraph describing a reconstituted tobacco having a nicotine content of less than 1.5% nicotine by weight. For example, [0101] describes that the “reconstituted plant material of the present disclosure can be combined with tobacco during the production of the reconstituted plant material to form an aerosol that produces an aerosol or smoke with a controlled amount of nicotine” and that “the reconstituted plant material may contain a low amount of nicotine, particularly as compared to a natural tobacco product, and may contain about 0.5% or less nicotine by weight of the reconstituted plant material.” In [0101], the reconstituted plant material includes tobacco and has a nicotine content of less than 0.5%.
Second, Applicant’s argument is unpersuasive because it relies on isolated teachings and does not consider Rousseau’s teachings as a whole. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." MPEP 2123(I). Here, Rousseau broadly teaches that a reconstituted plant material uses at least one of extracted cannabis fibers and extracted cocoa fibers in combination with at least one of extracted tobacco fibers, tobacco material, extracted herbal plant fibers, and aerosol generating herbal plant material ([0050], [0051]). Rousseau also teaches that “The reconstituted plant material of the present disclosure offers many advantages and benefits. For instance, the reconstituted material can be nicotine free…” ([0052]-[0053], referring back to the reconstituted plant materials previously introduced in [0050] and [0051]). The combination of these two teachings means that Rousseau contemplates a plant reconstituted plant material comprising extracted tobacco fibers and/or tobacco material that is nicotine free (i.e., “reconstituted tobacco material…having a nicotine content of less than 1.5% by weight of the reconstituted tobacco material”).
Third, Applicant’s citation to Example 3 and 4 does not teach away from Rousseau’s broader disclosure. “Disclose[d] examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” See MPEP 2123(II). As discussed in the two paragraphs above, Rousseau indeed teaches a reconstituted tobacco material having a nicotine content of less than 1.5%.
Lastly, Applicant attacks Rousseau individually whereas the rejection is based on the combination of Ballesteros and Rousseau. “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.” MPEP 2145(IV). Here, the combination relies on using Rousseau’s teachings for modifying the nicotine content in the reconstituted tobacco in Ballesteros.
Applicant' s arguments, see page 8, filed 3/2/2026, with respect to newly added claim 32 have been fully considered and are persuasive. Applicant has added claim 32 to include the limitation “wherein the total tobacco content of the reconstituted tobacco material is over 75% by weight of the reconstituted tobacco material.” Neither Ballesteros nor Rousseau disclose such a limitation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly cited prior art (see below).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 33 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 33, the claim limitation “the total tobacco content of the reconstitute tobacco material is over 75% by weight of the reconstituted tobacco material” lacks written description in the instant specification. Applicant notes that support for the claim can be found in Examples 1-3, Table 7. However, Examples 1-3 merely describe tobacco blends having 79.6, 79.4, and 79.2% tobacco respectively. These blends are not described as “reconstituted tobacco material.” Furthermore, even if the tobacco blends were to be considered to be “reconstituted tobacco material,” Applicant does not have support for the entire range of “over 75% by weight.” Particularly, Examples 1-21 have a tobacco total range of 79.2% to 82.9%, but do not describe amounts between 75-79% or above 83%.
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.
Claims 1-2, 4-12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable Ballesteros (WO 2018/100366; of record) in view of Zong (CN 104432480; of record; see machine translation), Wonowidjojo et al. (EP 3075272; of record), and Rousseau et al. (US 2020/0253269; of record) as evidenced by Reich et al. (US 2006/0237024; of record).
Regarding claims 1 and 6, Ballesteros discloses a smokable material having a tobacco composition (abstract; p. 7, l. 22-p. 8, l. 20; “tobacco composition”) comprising including a tobacco component (p. 23, l. 11-12) and an aerosol generating agent (p. 23, l. 28-p. 24, l. 21; “aerosol forming material”) in an amount of from 10-20% by weight of the tobacco composition (p. 29, ll. 28-31) and reconstituted tobacco (p. 29, ll. 24-26), wherein the tobacco component includes leaf tobacco in an amount of 10-30% or 10-20% by weight of the tobacco component (p. 27, ll. 3-5).
Ballesteros further discloses that the leaf tobacco compositions described herein may be any suitable tobacco, such as single grades or blends, cut rag, or whole leaf, including Virginia (flue-cured) and/or Burley and/or Oriental (p. 27, ll. 7-9), that the composition contain a nicotine content of 0.5-2.5%, such as 0.5-1.5% by weight of the tobacco composition (p. 24, ll. 29-31, p. 30, ll. 1-2), and that the tobacco composition includes a tobacco component in an amount of 60-90% by weight of the smokable material, a filler in an amount of 0-20% by weight of the smokable material, and an aerosol generating agent in an amount of from 10-20% by weight of the tobacco composition (p. 29, ll. 28-31).
However, Ballesteros does not explicitly teach wherein the leaf tobacco material has a nicotine content of greater than 1.5% by weight of the leaf tobacco material. Specifically, Ballesteros does not teach the nicotine content of their leaf tobacco.
Reich evidences a tobacco product (abstract) wherein chopped tobacco leaves usually include Virginia flue which typically contains around 2.5-3% nicotine, Burley tobacco typically having a higher nicotine content of around 3.5-5%, and Oriental tobacco, which is also typically a low nicotine variety ([0049]).
Zong teaches a low-tar flue-cured cigarette and formula ([0006]; “tobacco composition”) comprising flue-cured tobacco leaf raw materials with high nicotine content as the basis for leaf group formulation design ([0007]) wherein the nicotine content of the flue-cured tobacco leaves have a high nicotine content of 2-6% ([0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Zong’s flue-cured tobacco leaves with a high nicotine content of 2-6% as Ballesteros’ leaf tobacco including flue-cured tobacco to maintain the physiological strength while improving the aroma quality and sensory comfort while providing a low-tar tobacco material (Zong; [0004] and [0006]-[0007]).
Moreover, modified Ballesteros does not explicitly teach the reconstituted tobacco having a density of less than about 700 mg/cc. Specifically, Ballesteros does not disclose the possible densities used for their reconstituted paper tobacco material.
Wonowidjojo teaches a heater for generating aerosol in a rod comprising tobacco material (abstract), wherein the tobacco-containing material contains tobacco fibers and/or reconstituted tobacco with a density of 0.1 to 0.4 mg/mm3 ([0046], [0091], claim 27; equivalent to 100-400 mg/cc; “density of less than about 700 mg/cc”), wherein a sheet of reconstituted tobacco material is made from a paper making method ([0051]).
It would have been obvious to said skilled artisan to have modified the density of modified Ballesteros’ reconstituted paper tobacco material to have a density in the range of 0.1 to 0.4 mg/mm3 as in Wonowidjojo in order to obtain the predictable result of using a low density reconstituted tobacco material which has a higher porosity that can be filled in a greater proportion than traditional tobacco materials, and vaporizes flavors particularly well at lower temperatures to avoid generation of hazardous combustion products (Wonowidjojo; [0051]).
Lastly, modified Ballesteros does not explicitly teach the reconstituted tobacco having a nicotine content of less than 1.5% by weight of the reconstituted tobacco. Specifically, Ballesteros does not disclose the possible nicotine content of the reconstituted tobacco.
Rousseau teaches an aerosol generating material (abstract) wherein it is known that it is difficult to control the taste and active material content in reconstituted materials ([0006]) such as nicotine ([0003]). Rousseau solves such a problem by providing a reconstituted plant material comprising extracted tobacco fibers, including tobacco leaves, tobacco stems, byproducts of tobacco extraction, or mixtures thereof ([0008]-[0009]; “reconstituted tobacco”), wherein the reconstituted material may be nicotine free ([0052]; “nicotine content of less than 1.5% by weight of the reconstituted tobacco”) and combined with tobacco materials for forming an aerosol producing filler that has a tobacco taste that consumers desire while having reduced nicotine levels, wherein the proportion of the reconstituted plant material can be increased or decrease for controlling nicotine levels when combined with a tobacco material ([0053]; similar to in Ballesteros). Alternatively, Rousseau teaches that the reconstituted plant material may contain a low amount of nicotine, such as about 0.5 or less nicotine by weight of the reconstituted tobacco material, or may contain a “high” amount of nicotine as compared to the low nicotine embodiment containing greater than about 0.5% nicotine by weight of the reconstituted plant material ([0101], [0104]; “nicotine content of less than 1.5% by weight of the reconstituted tobacco”) which is then blended with a tobacco material for forming an aerosol generating material with reduced nicotine deliveries and a desired taste and smell ([0102]).
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 the nicotine content of the reconstituted tobacco combined with the leaf tobacco in Ballesteros to be nicotine free, low in nicotine (i.e., below 0.5%), or high in nicotine (i.e., above 0.5%, overlapping the claimed “less than 1.5% by weight”) as in Rousseau in order to obtain the predictable result of reducing nicotine deliveries while also providing a desirable taste and smell (Rousseau; [0102]) with the additional benefit of controlling the amount of nicotine being applied to the reconstituted plant material to allow for adjusting the precise amount of nicotine delivery in a uniform and consistent manner from puff to puff (Rousseau; [0103]).
Regarding claim 2, modified Ballesteros discloses the aerosol generating agent may be included in any component, for example adding to the tobacco composition separately (p. 24, ll. 23-27). This means that no aerosol generating agent is added directly to the leaf tobacco (i.e., 0% aerosol forming material; “up to about 10% by weight of the leaf tobacco material”).
Regarding claim 4, modified Ballesteros discloses applying menthol to the tobacco component (p. 2, l. 12) wherein menthol is incorporated for a cooling sensory effect and/or mint taste (p. 9, ll. 1-7), and wherein the smokable material may include a cooling agent combined with menthol to give a greater intensity and duration of a cooling sensation, wherein the cooling agent and menthol may be incorporated in any suitable amount with varying ratios (p. 22, ll. 11-23).
Thus, Ballesteros establishes that the amount of menthol in the smokable material a result effective variable that changes the cooling sensory effect and/or mint taste of the tobacco component (see p. 9, ll. 1-17 and p. 22, ll. 11-23).
However, Ballesteros does not explicitly teach the tobacco component comprises menthol in an amount of between about 3 mg and about 16 mg.
Therefore, it would have been obvious to change the amount of menthol in the tobacco component to obtain various amounts cooling sensation effect and/or mint taste because it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05 II(B).
Regarding claim 5, modified Ballesteros discloses the aerosol generating agent may be included in any component, for example adding to the tobacco composition separately (p. 24, ll. 23-27). This means that no aerosol generating agent is added directly to the leaf tobacco (i.e., 0% aerosol forming material; “up to about 10% by weight of the leaf tobacco material”). Moreover, modified Ballesteros discloses that the smokable material includes the aerosol generating agent in an amount of from 10-20% by weight of the tobacco composition (p. 29, ll. 30-31; “aerosol forming material in an amount between about 10% and about 30% of the tobacco composition” and “the total amount of aerosol forming material is between about 10% and about 20% by weight of the tobacco composition”).
Regarding claim 7, modified Ballesteros discloses the leaf tobacco is present in an amount of 10-20% by weight of the tobacco component (p. 27, ll. 3-5), which overlaps the claimed range of about 15% and about 25%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 8, modified Ballesteros discloses the tobacco composition has a nicotine content of from 0.5 to 1.5% by weight of the tobacco composition (p. 29, l. 31-p. 30, l. 2; “nicotine content up to 1.75% by weight of the tobacco component”).
Regarding claim 9, modified Ballesteros discloses the leaf tobacco includes Virginia (flue-cured) tobacco p. 10, ll. 4-7), wherein the nicotine content of the flue-cured tobacco leaves have a high nicotine content of 2-6% (Zong; [0008]).
Therefore, modified Ballesteros’ leaf tobacco having a high nicotine content of 2-6% overlaps the claimed range of about 1.5-4% by weight of the leaf tobacco material. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 10-11, modified Ballesteros discloses the aerosol generating agent may be glycerol present in an amount of from 10 to 20% by weight of the tobacco composition (p. 24, ll. 15-21).
Regarding claim 12 and 14, modified Ballesteros discloses the tobacco component includes a paper reconstituted tobacco in an amount of 70 to 100% by weight of the tobacco component (p. 26, ll. 4-10), which overlaps the claimed range of between about 50%-90%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 15, modified Ballesteros discloses the tobacco composition may include extruded tobacco and band cast tobacco in the tobacco component (p. 27, l. 14-p. 30, l. 6).
Regarding claims 16-17, Ballesteros discloses the smokable material comprises filler in an amount of 0 to 20% by weight of the smokable material (p. 29, ll. 29-30), which overlaps the claimed range of about 5% and about 10%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ballesteros in view of Zong, Wonowidjojo et al., and Rousseau et al. as evidenced by Reich et al. as applied to claim 12 above, and further in view of Renaud et al. (US 2012/0006343; of record).
Regarding claim 13, modified Ballesteros discloses the tobacco composition as discussed above with respect to claim 12, wherein the aerosol generating agent may be included in any component, for example the tobacco component (p. 24, ll. 23-27), which includes the paper reconstituted tobacco (p. 26, ll. 4-10).
However, modified Ballesteros does not explicitly teach wherein the paper reconstituted tobacco material comprises the aerosol forming material in an amount of between about 10% and about 20% by weight of the reconstituted tobacco material.
Renaud teaches a homogenized tobacco material (abstract) wherein the homogenized tobacco material uses a number of reconstitution processes to manufacture the homogenized tobacco, such as paper-making, casting, and extrusion ([0042]), wherein the homogenized tobacco material has an aerosol former content of between of 15-25% by weight ([0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the aerosol generating agent of Ballesteros in an amount of 15-25% by weight as in Renaud in order to facilitate a sensorially acceptable aerosol that advantageously delays combustion and pyrolytic degradation of the tobacco material (Renaud; [0055]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ballesteros in view of Zong, Wonowidjojo et al., and Rousseau et al. as evidenced by Reich et al. as applied to claim 1 above, and further in view of Rousseau et al. (US 2020/0275688; of record).
Regarding claim 18, modified Ballesteros discloses the tobacco composition as discussed above with respect to claim 1, wherein the leaf tobacco is a single grade or blend of cut rag (p. 27, ll. 7-9) and used in a heat not burn smoking article (abstract).
However, modified Ballesteros does not explicitly teach wherein the leaf tobacco material and/or a paper reconstituted tobacco material comprises a width of between about 0.5 mm and about 2 mm. Specifically, Ballesteros does not teach the width of the cut rag leaf tobacco.
Rousseau teaches an aerosol generating material (abstract) wherein it is known that cut rag refers to a cut reconstituted plant material ([0107]), wherein the reconstituted plant material can undergo cutting to have a desired particle size ([0107]), such cutting into cut rag with a width of 0.7 mm ([0133]), wherein the particle size for a smokeless blend product will generally be greater than about 50 microns and less than 3 mm ([0111]) for a smoking article that heats but does not combust to form an aerosol ([0032]).
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 the width of the cut rag in Ballesteros to be 0.7 mm as in Rousseau to achieve the predictable result of cutting the leaf tobacco to a desired particle size for a heat-not-burn smoking article (Rousseau; [0111]). Moreover, it would have been an obvious to said skilled artisan to perform such a modification since the modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04 (IV).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Ballesteros in view of Zong, Wonowidjojo et al., and Rousseau et al. as evidenced by Reich et al. as applied to claim 1 above, and further in view of Gindrat et al. (US 2014/0166032).
Regarding claim 33, modified Ballesteros discloses the tobacco composition as discussed above with respect to claim 1, wherein the paper reconstituted tobacco may be any type of paper reconstituted tobacco that is known in the art, and prepared by methods which are known to those skilled in the art (p. 26, ll. 20-30).
However, modified Ballesteros does not explicitly teach wherein the total tobacco content of the reconstitute tobacco material is over 75% by weight of the reconstituted tobacco material. Specifically, Ballesteros does not teach how much tobacco can be present in the paper reconstituted tobacco.
Gindrat teaches a sheet of homogenized tobacco material (abstract) comprising a tobacco content of about 70% or more by weight on a dry weight basis ([0071]; the Examiner interprets the term “about” to mean ±10%, meaning the Gindrat teaches 77% or more by weight). Gindrat further teaches that use of sheets of homogenized tobacco material having high tobacco contents advantageously generates aerosol with an enhanced tobacco flavor ([0071]).
Thus, Gindrat suggests that tobacco content is a result effective variable that affects the tobacco flavor generated in an aerosol.
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 the tobacco content in Ballesteros’ paper reconstituted tobacco to be about 70% or more as in Gindrat in order to obtain the predictable result of advantageously generating aerosols with an enhanced tobacco flavor (Gindrat; [0071]). Alternatively, it would have been obvious to increase the tobacco content in Ballestero’s paper reconstituted tobacco to obtain increased amounts of tobacco flavor generated in the aerosol because it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05 II(B).
Conclusion
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/SONNY V NGUYEN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755