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 Amendment
This office action is in response to Applicant’s amendment filed 4/30/2025.
Claims 15 and 26-27 are amended.
Claims 1-14, 20, 22, and 28 are cancelled.
Claims 15-19, 21, and 23-27 are pending.
The Applicant has overcome the rejection of claim 26 under 35 U.S.C. 112(d) as being in improper dependent form by amending the claim in the reply filed 4/30/2025.
Response to Arguments
Applicant' s arguments, see pages 8-9, filed 4/30/2025, with respect to the rejection(s) of claim(s) 15 and 27 under 35 U.S. 103 as being unpatentable over Metrangolo in view of Matsumoto and Saito and evidenced by Kao have been fully considered and are persuasive. The Applicant has amended claims 15 and 27 to include the limitation “the medium chain triglyceride oil is dispersed in liquid form within a solid matrix of the tobacco material such that the medium chain triglyceride is even distributed throughout the one or more sheets of homogenized tobacco material.” The prior art of record, Saito, 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 Therefore, the rejection has been withdrawn.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 (see below). The Examiner further addresses Applicant’s arguments regarding Matsumoto below.
Applicant's arguments filed 4/30/2025 regarding Matsumoto have been fully considered but they are not persuasive.
The Applicant maintains the position that Matsumoto teaches away from the use of less than 5 percent by weight of a stabilizer, representing a strong difference between claim 15 and the teachings of Matsumoto (p. 8).
The Examiner notes Applicant’s argument but finds it unpersuasive.
As previously noted in the Non-Final Office Action dated 1/30/2025, the Examiner finds Applicant’s argument unpersuasive because 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.
The Examiner further notes that Applicant has presented no further arguments or objective evidence of unexpected results or criticality in their arguments. Therefore, the Examiner maintains the position that the claimed range of “less than 5 percent,” including a lower range of 4.99 repeating, is obvious over Matsumoto’s lower endpoint of 5% because they are so mathematically close without any showing of unexpected results or criticality.
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 Matsumoto et al. (US 2013/0284193; of record) and Hassler et al. (US 2020/0128870) 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 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 one of ordinary skill in the art before the effective filing date of the claimed invention 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).
Moreover, 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
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.
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/SONNY V NGUYEN/Examiner, Art Unit 1755
/ERIC YAARY/Examiner, Art Unit 1755