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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/8/2025 has been entered.
Response to Amendment
This office action is in response to Applicant’s amendment filed 12/8/2025.
Claims 15 and 27 are amended.
Claims 1-14, 20, 22, and 28 are cancelled.
Claims 15-19, 21, and 23-27 are pending.
Response to Arguments
Applicant' s arguments, see page 10, filed 12/8/2025, with respect to the rejection(s) of claim(s) 15-19, 21, and 23-27 under 35 U.S.C. § 103 as being unpatentable over Metrangolo in view of Matsumoto and Hassler as evidenced by Kao have been fully considered and are persuasive. Applicant has amended claims 15 and 27 to include the limitation “wherein the particles of tobacco material have a mean particle size of between 0.03 millimetre and 0.12 millimetre.” The prior art of record fails to 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 Therefore, the rejection has been withdrawn.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.
Applicant's arguments filed 12/8/2025 regarding the combination of Metrangolo, Matsumoto, and Hassler have been fully considered but they are not persuasive.
Applicant argues that the feature of “at least 1 percent by weight and less than 5 percent by weight of a medium chain triglyceride (MCT) oil on a dry weight basis” represents unexpected results (p. 8). Specifically, Applicant notes that the liquid medium chain triglyceride oil acts to facilitate transfer of volatile components form the homogenized tobacco material to its surface and therefore enhance the transfer of these volatile components in comparison with a homogenized tobacco material that does not contain the liquid medium chain triglyceride oil (citing Instant Specification at p. 6, ll. 11-19) and allowing equivalent nicotine or aerosol yields at lower temperatures in comparison to substrate not containing MCT oil (citing Instant Specification at p. 6, ll. 30-36) (p. 8).
The Examiner finds Applicant’s argument unpersuasive. Particularly, Applicant’s argument concerns unexpected results when compared to a homogenized tobacco material that does not contain the liquid medium chain triglyceride oil. However, the rejection at issue contains a lower end range of 5% medium chain triglyceride oil in the form of Coconad MT (Matsumoto; [0013]). Therefore, Applicant’s reasoning that the claimed invention enhances transfer over homogenized tobacco material apply to the current rejection because Applicant fails to compare the claimed subject matter to the closest prior art. See MPEP 716.02(e).
Applicant further notes that the inventors have found that improvements in the delivery of nicotine and aerosol can be provided with a low proportion of the MCT oil in homogenized tobacco material (citing p. 7, ll. 6-11) (p. 8). Applicant argues that improved nicotine and aerosol delivery with a low proportion of MCT oil (i.e., less than 5 percent) is an unexpected result over Matsumoto’s teaching that if the stabilizer content is less than 5 percent by weight, the nicotine required is not stabilized (citing [0013] of Matsumoto) (p. 8). Applicant emphasizes that less than 5 percent of a stabilizer is prejudicial to the technical effect described in the disclosure and one of ordinary skill would not expect less than 5 percent by weight of MCT oil to bring about any positive technical effect (p. 8-9).
The Examiner finds Applicant’s argument unpersuasive. Applicant bears the burden of establishing that the results are unexpected and significant. MPEP 716.02(b)(I). In this case, Applicant has the burden to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show criticality of the claimed range. MPEP 716.02(d)(II).
First, Matsumoto still teaches a lower end point of 5% stabilizer ([0013]). This endpoint, while not overlapping the claimed range, is close to the upper endpoint of the claimed range of “less than 5 percent by weight of a medium chain triglyceride oil.” A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP 2144.05(I). See also In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018) (the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.). Here, the claimed range of “less than 5 percent” (including 4.99 repeating) is so close to Matsumoto’s lower endpoint of 5% that the difference is virtually negligible absent a showing of unexpected results or criticality.
Second, the Examiner notes that stabilizing nicotine delivery in Matsumoto is not the same as improving nicotine and aerosol delivery in the instant application. Matsumoto’s reference to stabilizing nicotine delivery means that the amount of nicotine delivered changes only a little over long periods of time ([0060]; i.e., nicotine amount/puff changes little). The instant application refers to nicotine and aerosol delivery in the total amount of nicotine delivered (see Table 2 of the instant specification). In referring to [0013] of Matsumoto, Applicant is comparing wholly different properties.
Lastly, Applicant’s own specification indicates that an aerosol-generating substrate having 5% MCT (i.e., Matsumoto’s lower end point) delivers 1.42 mg of nicotine and 1.00 mg of nicotine at 350°C and 300°C respectively compared to lower amounts of nicotine delivered by aerosol-generating substrates having 1.0 and 2.5% MCT (see Table 2). Thus, Applicant’s own specification disproves Applicant’s assertion that tobacco substrates having less than 5% of MCT oil will improve nicotine and aerosol delivery. Rather, Applicant’s own specification shows that aerosol-generating substrates having 5% deliver more nicotine than aerosol-generating substrates having less than 5%.
Applicant argues that Hassler is not from the same field of endeavor as the claimed invention (p. 9). Applicant characterizes the claimed invention to being the field of aerosol-generating articles designed to release a vapor upon heating, and Hassler being in the field of oral pouched nicotine products (p. 9).
The Examiner has noted Applicant’s argument but finds it unpersuasive. Applicant narrowly construes the field of endeavor of the claimed invention and Hassler. "The field of endeavor is ‘not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field.’" MPEP 2141.01(a)(I). Here, both the claimed invention and Hassler can be characterized as having a broader field of endeavor. Patent Office classification of references are some evidence of analogy. MPEP 2141.01(a)(II). Here, both the instant application and Hassler are classified in CPC A24B: 15/30, relating to the treatment of tobacco products using organic substances. More broadly, both the instant application and Hassler are related to the formation of homogenous tobacco products having MCT (Hassler, [0063]-[0064], describing the triglyceride is homogeneously distributed in the filling material including tobacco material; Instant application, p. 1, l. 4, describing a homogenized tobacco material). Therefore, the Examiner maintains that Hassler is in the same field of endeavor as the claimed invention.
Applicant further argues that Hassler is not reasonably pertinent to the problem faced by the inventors (p. 9). Applicant argues that Hassler addresses the problem of preventing the loss of flavor before use of oral pouched nicotine products and the negative impact flavors in such pouched products have on the seal strength of the resulting products (p. 9). Applicant further argues that the claimed invention relates to the problem of improving the delivery the delivery of nicotine and aerosol in a heating aerosol-generating article without impacting the remaining components in the substrate (p. 9-10).
The Examiner respectfully disagrees. Applicant merely compares the problem Hassler addresses to the problem that the inventors of the instant application have addressed. However, that is not the proper test. Rather, in order for a reference to be "reasonably pertinent" to the problem, it must "logically [] have commended itself to an inventor's attention in considering his problem.” MPEP 2141.01(a)(I). Here, the instant application is related to solving the problem of improving the delivery of volatile compounds such as nicotine (p. 3, ll. 25-26) by using MCT oil in the homogenized tobacco material (p. 6, ll. 26-29). One of skill in the art would need to consider how to properly incorporate the MCT oil in the tobacco material (see p. 6, ll. 11-19). Thus, one of skill in the art would have considered different configurations of incorporating MCT oil into tobacco, such as Hassler’s teaching of homogeneously mixing triglyceride with tobacco material ([0063]-[0064]).
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.
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 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 15-19, 21 and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Metrangolo et al. (US 2015/0150302; of record) in view of Klipfel et al. (WO 2016/050469), Matsumoto et al. (US 2013/0284193; of record), and Hassler et al. (US 2020/0128870; of record), as evidenced by Kao Corporation (“Safety Data Sheet of Coconad MT”; of record).
Regarding claims 15 and 26-27, Metrangolo discloses an aerosol generating system (2000) comprising:
an electrically operated aerosol-generating device (2010; Fig. 11) comprising a heating blade (2100; “heating element”); and
a rod for an aerosol-generating article (abstract; “heatable aerosol-generating article for producing an inhalable aerosol”) comprising a rod (see Fig. 9-10) of an aerosol-forming substrate (1020; “rod of aerosol-generating substrate”), the rod being formed from two sheets of homogenized tobacco material that are gathered into a rod (see Fig. 3-8; para. 110, 135; “one or more sheets of a homogenized tobacco material”), the sheets are formed by agglomerating particulate tobacco (para. 22; “agglomeration of particles of tobacco”), wherein the homogenized tobacco may comprise aerosol forming compounds such as glycerine and propylene glycol (para. 34; “one or more aerosol formers”), and wherein the two sheets are preferably a reconstituted tobacco sheet (para. 98) or a cast leaf process (para. 98).
However, Metrangolo is silent as to the particles of tobacco having a mean particle size of between 0.03 millimeter and 0.12 millimeter.
Klipfel teaches a method for the production of a slurry for homogenized tobacco material (abstract) wherein the tobacco present in the homogenized tobacco material impacts the characteristics of the aerosol (p. 2, ll. 12-15) such that the tobacco lamina for the homogenized tobacco material needs to be ground into powder in order to reach substantially the same size dust used in reconstituted tobacco because too big tobacco particles (i.e., bigger than about 0.15 millimeters) may cause defects and inhomogeneous areas in the homogenized tobacco web that is formed from tobacco powder, reducing the tensile strength, and leading to difficulties in handling the homogenized tobacco web (p. 2, ll. 25-34) and may create untended differences in the aerosol delivery (p. 3, ll. 1-3), wherein it is believed that fine grinding to about 0.05 millimeters can be advantageously open up the tobacco cell structure (p. 3, ll. 5-8; see also p. 7, ll. 26-30, teaching a mean size of between about 0.03 mm and about 0.12 mm).
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 particulate material of Metrangolo to be about 0.05 mm as in Klipfel in order to improve the aerosolization of substances from tobacco and advantageously open up the tobacco cell structure (Klipfel; p. 3, ll. 5-8) while avoiding the problem of forming inhomogeneous areas in the homogenized tobacco (Klipfel; p. 2, ll. 25-34).
Moreover, Metrangolo is silent as to at least 1 percent by weight and less than 5 percent by weight of a medium chain triglyceride oil on a dry weight basis, the medium chain triglyceride oil having a melting point below 18 degrees Celsius and comprising one or more triglycerides having at least two fatty acid chains with a chain length of between 6 and 12 carbon atoms.
Matsumoto teaches a non-combustion suction type tobacco product (abstract; “heated aerosol-generating article”) comprising: a tobacco cartridge (6; see Fig. 1; see para. 23 describing the frame member having an internal diameter of 26 mm; “rod of aerosol-generating substrate”) comprising tobacco particles (20) comprising a mixture of particles obtained by shredding or pulverizing (para. 30) and a stabilizer of medium-chain triglyceride consisting primarily of triglyceride caprylate, or more specifically Coconad MT (para. 40; “medium chain triglyceride oil”) preferably having a content of 5-20 percent by weight relative to the dry weight of the tobacco particles (para. 13).
It would have been obvious to said skilled artisan to have added a stabilizer in the form of a medium-chain triglyceride such as Coconad MT in an amount of 5 percent by weight as in Matsumoto to Metrangolo’s homogenized sheets of tobacco because the addition of Coconad MT is known to stabilize the delivery of nicotine over long period of time thereby greatly increasing the satisfaction per puff of a user (Matsumoto; para. 6). Thus, modified Metrangolo’s tobacco product includes the lower endpoint of 5 percent by weight Coconad MT which is close to the lower end point of the claimed range of “less than 5 percent by weight.” A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP 2144.05(I). See also In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018) (the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality).
Regarding the claim limitation “the medium chain triglyceride oil having a melting point below 18 degrees Celsius and comprising one or more triglycerides having at least two fatty acid chains with a chain length of between 6 and 12 carbon atoms,” Kao is used as evidence to show that Coconad MT has a melting point of -20°C (see p. 3) and is a caprylic and capric triglyceride (p. 2; “triglycerides having at least two fatty acid chains with a chain length of between 6 and 12” as it is well known that caprylic acid is a saturated fatty acid with 8 carbon atoms and capric acid is a saturated fatty acid with 10 carbon atoms).
Lastly, Metrangolo suggests the sheet has consistent properties and a homogenized flavor ([0028]), and that the homogenized tobacco materials may include various other additives such as flavourants ([0039]).
However, modified Metrangolo does not explicitly teach wherein the medium chain triglyceride oil is dispersed in liquid form within a solid matrix of the tobacco material such that the medium chain triglyceride oil is evenly distributed throughout the one or more sheets of homogenized tobacco material. Specifically, Matsumoto does not teach or suggest how the stabilizer would be added to the tobacco sheets of Metrangolo.
Hassler teaches a nicotine product (abstract) comprising a moist filling made of a homogeneous mixture of a flavoring agent, a nicotine source, a triglyceride, and a tobacco material ([0064]; “homogenized tobacco material”), wherein the triglyceride includes a medium-chain triglyceride ([0062]), wherein the triglyceride may be a vegetable oil which is liquid at room temperature ([0058]; “in liquid form”) such as coconut oil ([0060]; known to be rich in MCT), and wherein the triglyceride is homogeneously distributed in the moist filling material ([0062]; “evenly distributed throughout…the homogenized tobacco material”).
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 modified Metrangolo’s medium-chain triglyceride stabilizer such that it was homogeneously distributed in Metrangolo’s tobacco sheet filling material as in Hassler because (a) Metrangolo suggests the tobacco material has consistent properties ([0028]) and such a modification would achieve such consistent properties by homogeneously distributing the triglyceride in the tobacco filling material (Hassler; [0063]), and (b) the homogeneously distributed triglyceride would act in concert with Metrangolo’s flavourant additive and nicotine to improve flavor preservation and/or improve shelf life stability in the nicotine product (Hassler; [0018], [0096]-[0097]).
Regarding the claim limitation “wherein the medium chain triglyceride oil is dispersed in liquid form…[and] is evenly distributed throughout the one or more sheets of homogenized tobacco material“ one of ordinary skill in the art would appreciate that the stabilizer in the form of a medium-chain triglyceride such as Coconad MT has a melting point of -20°C (Kao; see p. 3). Therefore, the medium chain triglyceride such as Coconad MT would remain a liquid at room temperature when present in modified Metrangolo’s tobacco sheet.
Regarding claim 16, regarding the claim limitation “wherein the medium chain triglyceride oil has an iodine value of less than 2,” the instant specification notes that the iodine value corresponds to the mass of iodine in grams consumed by 100 grams of medium chain triglyceride oil, and that the lower the iodine number, the fewer the double bonds are present in the medium chain triglyceride oil and therefore the higher the degree of saturation (p. 8, ll. 5-13). Since modified Metrangolo discloses the same chemical as claimed (i.e. the medium chain triglyceride having at least two fatty acid chains with a chain length between 6-12 carbons) and discloses the fatty acids are fully saturated fatty acids (capric acid and caprylic acid), the Coconad MT is expected to have an iodine value of less than 2. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 17-18, regarding the claim limitations “wherein the medium chain triglyceride oil has a melting point below 15 degrees Celsius” and “wherein the medium chain triglyceride oil has a melting point below 10 degrees Celsius,” Kao is used as evidence to show that Coconad MT has a melting point of -20°C (see p. 3). Therefore, the Coconad MT in modified Metrangolo will have a melting point of -20°C.
Regarding claim 19, regarding the claim limitation “wherein the medium chain triglyceride oil comprises at least 80 percent triglycerides having at least two fatty acid chains with a chain length of between 8 and 10 carbon atoms,” Kao is used as evidence to show that Coconad MT is a caprylic and capric triglyceride (p. 2; “triglycerides having at least two fatty acid chains with a chain length of between 6 and 12” as it is well known that caprylic acid is a saturated fatty acid with 8 carbon atoms and capric acid is a saturated fatty acid with 10 carbon atoms). Therefore, the Coconad MT in modified Metrangolo will comprise at least 80 percent triglycerides having at least two fatty acid chains with a chain length of between 8 and 10 carbon atoms.
Regarding claim 21, modified Metrangolo discloses that the sheet of homogenized tobacco material may have a tobacco content of about 70% or more by weight on a dry weight basis (para. 89).
Regarding claim 23, modified Metrangolo discloses the that the sheets of homogenized tobacco material may include an aerosol former of greater than 5% to about 30% (para. 96). In a specific example, modified Metrangolo discloses that a first tobacco material comprises 5% glycerine and a second tobacco material comprises 10% by weight glycerine (para. 37).
Regarding claim 24, modified Metrangolo discloses non-tobacco fibers (para. 90, 92) wherein the non-tobacco fibers are between about 1% and 5% on a dry weight basis (para. 94) and wherein the added non-tobacco fibers achieve an appropriate tensile strength (para. 93).
Regarding claim 25, modified Metrangolo discloses wherein the rod is formed from two sheets of homogenized tobacco material that are gathered into a rod (see Fig. 3-8; para. 110, 135).
Conclusion
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/SONNY V NGUYEN/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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