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 .
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.
Response to Amendment
Claims 16, 18, and 27 are amended. Claims 17 and 21 are cancelled. Claims 16, 18-20, and 22-30 are presently examined.
Response to Arguments
Applicant’s amendments and remarks filed April 1, 2026, with respect to the rejections under § 103 have been fully considered but they are not persuasive.
Applicant argues the claims are not directed to the mere selection of a numerical temperature or time within a known range, but instead recite a specific extraction process...specific process steps, sequencing and operating conditions that materially affect how the claimed method functions, the Examiner must still explain why the person of ordinary skill in the art would have reasonably expected those conditions to operate in the claimed manner and product the claimed result. The Examiner respectfully disagrees as the prior art is treating tobacco in an extraction process similar to the Applicant’s claimed process with similar temperature ranges and, therefore, the same or substantially similar result is expected absent evidence to the contrary. Applicant presents no demonstration of differences in temperatures of treatment (inside or outside the claimed range) and, therefore, Applicant has not provided sufficient evidence to pass the burden back to the Office on this issue under in re Wertheim.
Applicant argues Fujisawa does not define any specific extraction time, then states the examples in Fujisawa seem to have treatment times of around 180 minutes to 300 minutes. The Examiner respectfully disagrees for the reasons originally put forth in the rejection of claim 16. Specifically, Fujisawa discloses the extraction method comprises a step A for heating a tobacco raw material which is subjected to alkali treatment. In a case where a stable zone in which variations of pH of the collection solution are within a predetermined range exists in a time axis elapsing from the beginning of the step A after pH of a collection solution containing the collection solvent and release component decreases by 0.2 or more from the maximum value, the first condition is a condition that at time elapsing from the beginning of step A reaches a start time of the stable zone [0033]. In Fig. 6 and Fig. 7, the treatment time is a time elapsing from the beginning of the heating treatment (step S20) of a tobacco raw material; it can be thought that the treatment time is a time elapsing from the beginning of the collection treatment (step S30) of a flavor constituent (hereinafter, a nicotine component); as shown in Fig. 7, the stable zone starts at a treatment time of approximately 40 minutes [0098], which is greater than the claimed 15 minutes as is the time range cited in examples of Fujisawa cited by Applicant’s arguments.
Applicant argues there is no teaching or suggestion in Fujisawa of heating the tobacco material in a flow of inert gas. The Examiner respectfully disagrees as Applicant’s arguments do not address Examiner’s rejection of the claimed heating the tobacco material in a flow of inert gas which included specific references to air and inert gases argon and nitrogen. Applicant further cites advantageous effects to nitrogen/inert gases compared to air exemplified by Fujisawa. Applicant presents no evidence or demonstration supporting their speculation to advantageous effects in choosing inert gas flows. This argument is not persuasive the above reasons.
Applicant’s arguments regarding there is no teaching or suggestion in Fujisawa of heating the tobacco material using microwave heating are found not persuasive as Fujisawa was not utilized to reject the claimed microwave heating.
Applicant argues there is no reason why a person skilled in the art would look to the teachings of Lin to modify the extraction method described in Fujisawa as Lin teaches a microwave assisted solvent extraction method. Firstly, a reference is good for all that it teaches and Lin is available as prior art. This makes any disclosure available to be used. Lin teaches during microwave extraction, the cells (e.g., the cells of the tobacco leaf material) absorb microwave energy and their temperature rises rapidly, leading to increased internal cell pressure. When this pressure exceeds the limit that the cell wall can withstand, the cell ruptures; the effective components inside the cell can flow out and dissolve in the extraction medium to be available to obtained through further separation and filtration [0006]. There is nothing in Lin that suggests to one of ordinary skill in the art that the cells of a microwave heated tobacco material will only rupture and release volatile components only if the tobacco material is present in a liquid solvent. As the art is available, all the teachings of Lin are available and the fact that Applicant may consider the teachings as not motivating in view of the liquid solvent extraction process of Lin does not mean they are not available to be used nor does it mean that a person of ordinary skill in the art would consider them as not motivating also, and for some reason choose to not use them. Additionally, Applicant’s as-filed specification page 4 lines 7-16, teaches microwaves heat the tobacco from the inside, by rapidly heating the water molecules with the tobacco cells. When the water inside the tobacco cells boils, the volume inside the cell is expanded rapidly and the cell wall eventually ruptures which increases the permeability of the plant material and importantly, releases components that are contained within the cell wall, such as nicotine. Additionally, Applicant’s arguments do not address the motivation supplied in the reject to modify Fujisawa. The Examiner respectfully disagrees with Applicant’s arguments for the reasons discussed above. There is no requirement that Fujisawa has to suggest microwave heating in order to modify it nor has Applicant argued that microwave heating as put forth in the rejection of record somehow compromises the principle of Fujisawa. In this instance, one looking to microwave heat a tobacco material to an extraction temperature would look to Lin for a means to incorporate microwave heating of a tobacco material when producing a liquid tobacco extract.
Applicant argues as described in Lin, one of the main technical benefits of the use of microwave heating is to reduce the amount of solvent required and to reduce the heating time. The Examiner respectfully disagrees as Lin teaches, compared with traditional extraction methods described in existing technologies, microwave-assisted extraction of natural products requires less reagent, is energy-efficient, and produces less pollution ([0039]).
Further, Applicant argues there is no description in Lin relating to the improvement of extraction of efficiency of nicotine, or any other tobacco compounds, and there is no description of improvement of extraction efficiency in relation to Lin’s method. The Examiner respectfully disagrees. Lin teaches because a blend of tobacco leaves is used to make the tobacco extract, and microwave-assisted extraction technology is employed to minimize the damage and loss of flavor components, its aroma is closer to the aroma of cigarettes ([0019]).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues the references failed to teach or suggest each and every element in at least Applicant’s independent claim 16 and that a person of ordinary skill would not have reasonably predicted the claimed invention based on the prior art, and the resulting invention would not have been expected. The Examiner respectfully disagrees. A reasonable expectation of success is not required to be articulated as there is no requirement for the reasonable expectation of success to be explicitly stated. See MPEP 2143.02.I. Further, each limitation of the claimed invention is addressed in the rejections.
The remaining arguments are directed to amendments to the claims which are addressed in the rejection below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-18, 22-23, and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Fujisawa et al. (US 2016/0360780, as cited on IDS dated 8/21/2023) in view of Lin (CN105341998A, cited on IDS dated 6/02/2023, machine translation relied upon).
Regarding claims 16-18, 25, and 30, Fujisawa discloses a method of producing a liquid tobacco extract (abstract, an extraction method of flavor constituent) the method comprising the steps of:
preparing a tobacco material, ([0046] the tobacco raw material 50 may be constituted of a cut or powder tobacco raw material, reading over the preparing limitation);
heating the tobacco material at an extraction temperature of between 100 degrees Celsius and 160 degrees Celsius for at least 15 minutes, wherein the tobacco material is heated directly ([0040] a tobacco raw material 50 is put in the container 11. The container 11 is constituted of for example members with heat resistance and pressure resistance (e.g., SUS; Steel Use Stainless); [0067], Step 20, in the heating treatment, the tobacco raw material 50 can be heated with the container 11 with the tobacco raw material 50 put in the container 11 in the alkali treatment device 10. This reads over the tobacco material is directly heated (Claim 16) and further reads over conventional heating (Claim 18) as container 11 is constituted of Steel Use Stainless (i.e., stainless steel) and is heated with the tobacco as discussed in [0040]; further, conventional heating methods can only heat the tobacco material from the outside, as compared to microwaves which heat the material from inside the tobacco material, (as filed specification page 4 lines 24-27); [0068] the heating temperature of the tobacco raw material 50 is in a range from 80o C or more to less than 150o C).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose a heating temperature range from 80o C or more to less than 150o C because the prior art discloses a range that overlaps the claimed range of between 100 degrees Celsius and 160 degrees Celsius (Claim 16) and between 125 degrees Celsius and 160 degrees Celsius (Claim 25). In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990), In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) and MPEP § 2144.05 (I).
Fujisawa discloses the tobacco material is heated in a flow of inert gas, ([0070-0071], the tobacco raw material 50 is subjected to an aeration treatment (i.e., a flow of gas) in Step S20 (heating treatment); the gas used in the aeration treatment is not limited to air and may be inert gases such as nitrogen and argon). This reads over the tobacco material is heated in a flow of inert gas of Claim 16.
Fujisawa discloses the liquid extract method additionally comprises a heating time of at least 15 minutes, ([0033], the extraction method comprises a step A for heating a tobacco raw material which is subjected to alkali treatment. In a case where a stable zone in which variations of pH of the collection solution are within a predetermined range exists in a time axis elapsing from the beginning of the step A after pH of a collection solution containing the collection solvent and release component decreases by 0.2 or more from the maximum value, the first condition is a condition that at time elapsing from the beginning of step A reaches a start time of the stable zone; [0098], Fig. 6 and Fig. 7, the treatment time is a time elapsing from the beginning of the heating treatment (step S20) of a tobacco raw material; it can be thought that the treatment time is a time elapsing from the beginning of the collection treatment (step S30) of a flavor constituent (hereinafter, a nicotine component); as shown in Fig. 7, the stable zone starts at a treatment time of approximately 40 minutes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention further be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose a heating treatment time of approximately 40 minutes because the prior art discloses a range that encompasses the claimed range of at least 15 minutes heating time (Claim 16). In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990), In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) and MPEP § 2144.05 (I).
Fujisawa discloses the liquid extract method further comprises collecting volatile compounds released from the tobacco starting material during the heating step (Fig. 2, [0047]-[0048], the collection device 20 has a container 21, a pipe 22, a release section 23 and a pipe 24; a collection solvent 70 is put in the container 21; [0050], the pipe 22 takes release component 61 (reads over volatile compounds) which is released in the gas phase from the tobacco raw material 50, to the collection solvent 70, wherein the release component 61 contains at least a nicotine component which is an index of a flavor constituent; [0072], in step S30, a release component which is released in the gas phase in Step S20 is brought into contact with the collection solvent 70 at normal temperature until any time when the first condition is satisfied (see [0033]) to when the second condition is satisfied (see [0033]) using the collection device 20. This reads over the collection of volatile compounds released from the tobacco starting material during the heating step; forming a liquid tobacco extract comprising the collected volatile compounds (Claim 16) and a liquid tobacco extract produced by the method (Claim 30).
Fujisawa does not explicitly disclose the step of preparing the tobacco material comprises pre-treating the tobacco material by microwave heating to bring about rupture of tobacco cells, prior to the heating step (Claim 16).
Lin teaches a method for preparing an electronic cigarette liquid (i.e., liquid tobacco extract) through microwave-assisted extraction. An extraction liquid and mixed tobacco leaves are mixed and irradiated by microwaves (abstract). Lin teaches during microwave extraction, the cells (e.g., the cells of the tobacco leaf material) absorb microwave energy and their temperature rises rapidly, leading to increased internal cell pressure. When this pressure exceeds the limit that the cell wall can withstand, the cell ruptures; the effective components inside the cell can flow out and dissolve in the extraction medium to be available to obtained through further separation and filtration [0006]. Lin further teaches microwave-assisted extraction has the advantages of fast extraction speed, low solvent consumption, and high extraction efficiency [0016]. Lin further teaches a microwave radiation time of is 2-10 minutes [0027].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujisawa and limit preparing the tobacco material to include a preparatory microwave heat treatment of the tobacco material that is subjected to a microwave radiation time of 2-10 minutes prior to the extraction heating process in order to rupture the cells of the tobacco raw material of Fujisawa as taught by Lin. One of ordinary skill in the art would have a reasonable expectation of success in making such modification as the preparatory microwave heat treatment of the tobacco material step is performed to cause the rupture of tobacco cells prior to the step of the extraction heating process of Fujisawa, which results in shorter extraction times due to improved extraction speed and higher extraction efficiency due to the ruptured cells as taught in Lin [0016]. This reads over the step of preparing the tobacco material comprises pre-treating the tobacco material by microwave heating to bring about rupture of tobacco cells prior to the heating step (Claim 16).
Regarding claims 22 and 23, Fujisawa discloses the tobacco material has a moisture content of at least 10 percent by weight at a start of the microwave heating ([0060], the tobacco raw material 50 may be subjected to a water addition treatment in Step S10; the amount of water in the tobacco raw material 50 before the water addition treatment is preferably 10 wt % or more (reads over at least 10 percent by weight at a start of the microwave heating of Claim 22). The upper limit of the amount of water is not particularly limited, and for example, further preferably 30 wt % or more; preferably 50 wt % or less to efficiently heat the tobacco raw material 50, reading over applying water to the tobacco material prior to the microwave heating step in order increase the moisture content of the tobacco material to a least 10 percent by weight of Claim 23.
Regarding claim 26, Fujisawa discloses the extraction temperature is selected to provide a liquid tobacco extract having a nicotine content of at least 0.2 percent by weight based on dry weight, ([0068], by setting heating temperature of the tobacco raw material 50 to 80o C or more, a time when a flavor constituent (e.g., nicotine) is sufficiently released from the tobacco raw material can be earlier and by setting the heating temperature of the tobacco raw material 50 to less than 150o C, meanwhile, a time when TNSA is released from the tobacco raw material 50 can be delayed; [0078], In a dry state, based on the tobacco raw material 50 is 100 wt %, the second condition is a condition that the remaining amount of flavor constituent (herein, a nicotine component) contained (e.g., remaining) in the tobacco raw material 50 decreases until reaching 0.3 wt % in the case where the weight of the tobacco raw material 50 in the dry state is 100 wt %). This reads over at least 0.2 percent by weight based on dry weight limitation of the claim.
Regarding claim 27, modified Fujisawa discloses the step of subjecting the tobacco material to an alkali treatment prior to the heating step and prior to the pre-treating step, (Fujisawa Fig. 4, [0062], an alkaline substance is provided for the tobacco raw material 50 using the alkali treatment device 10 described in Step S10, reading over subjecting the tobacco material to an alkali treatment prior to the heating step and prior to the pre-treating step). This reads over the claim.
Regarding claim 28, Fujisawa discloses the step of spraying atomized water onto the tobacco material during the heating step, ([0069], the tobacco raw material 50 can be subjected to a water addition treatment in Step S20. In addition, water may be continuously added to the tobacco raw material 50 in Step S20.
One of ordinary skill in the art would be reasonably suggested to continuously add water to the tobacco raw material 50 during the heating step by spraying water in droplet form, e.g., atomized form, onto the tobacco raw material in the chamber 11 since it is well known in the art to add water to a tobacco material through a spray nozzle which atomizes the water flowing through the spray nozzle. Furthermore, Applicant’s specification admits that methods of atomizing water, including water may be atomized without a flow gas due to the pressure within the spray nozzle, are known in the prior art at page 13, lines 32-34. This reads over the claim.
Regarding claim 29, Fujisawa discloses the step of drying or concentrating the collected volatile compounds, ([0080], in Step S40, in order to raise the concentration of a flavor constituent contained in a collection solution, the collection solvent 70 which has captured the flavor constituent is subjected to a vacuum concentration treatment a heating concentration treatment or a salting-out treatment). The reads over the step of drying or concentrating the collected volatile compounds.
Claims 19-20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Fujisawa et al. (US 2016/0360780, as cited on IDS dated 8/21/2023) in view of Lin (CN 105341998 A, cited on IDS dated 6/02/2023, machine translation relied upon) as applied to claim 16 above, and further in view of Anizon et al. (FR 2955331 A1, cited on IDS dated 6/17/2025).
Regarding claims 19 and 20, modified Fujisawa discloses all the claim limitations as set forth above; specifically modified Fujisawa discloses conventional heating (Fujisawa [0067]) as discussed in claim 16 rejection above.
Modified Fujisawa does not explicitly disclose the step of heating of the tobacco material comprises microwave heating (Claim 19) or the heating step comprises a combination of microwave heating and conventional heating (Claim 20).
Anizon teaches a process of extracting a natural product comprising a volatile molecule (i.e., material) and/or a less volatile molecule from a biological material by microwaves (abstract, description pg 1). Another objective of the invention is to propose such a process which allows extraction of all the molecules of an essential oil, or at least an improved extraction compared to prior art processes, including molecules with low volatility, including molecules with low volatility (description pg 3). The extraction of natural products from biological material is obtained in the following way: the material is placed in a closed container; the chamber is then pressurized by increasing the pressure inside the chamber to a pressure greater than 1 bar, called the initial pressure; when the pressure in the chamber is greater than 1 bar, in particular when the pressure is between 1.1 and 5 bars, preferably between 1.3 and 3 bars, the biological material is then subjected to microwave irradiation, which will heat said material; when the temperature of the biological material and the temperature inside the chamber reaches a temperature greater than 100o C, in particular when the temperature is between 100o C and 160o C, and preferably between 102o C and 125o C, the microwave irradiation leads to the release, in the form of vapor, of at least part of a natural product consisting of at least one volatile molecule inside said enclosure (description pg 4), reading over microwave heating the 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 practice the invention of modified Fujisawa to include heating the tobacco material of modified Fujisawa by microwave heating as taught by Anizon. One of ordinary skill would be motivated to make such motivation with a reasonable expectation of success since Anizon teaches microwave irradiation results in a chamber temperature and a biological material temperature between 100o C and 160o C, and preferably between 102o C and 125o C, leads to the release, in the form of vapor, of at least part of a natural product consisting of at least one volatile molecule inside the chamber, which is what modified Fujisawa wants, a release component, which is released in the gas phase from the tobacco raw material (Fujisawa [0050]). This reads over heating the tobacco material comprises microwave heating the tobacco material of Claims 19 and 20.
Anizon additionally teaches the pressurization step of the enclosure consists of injecting pressurized steam into the enclosure. In a particular embodiment, the injected steam has a temperature between 102o C and 160o C, preferably between 109o C and 124o C. The injection of steam as such temperature makes it possible both pressurize the chamber and to heat the biological material (reads over conventional heating the tobacco material) while also warming (e.g., heating) the chamber (description pg 6). This reads over heating the tobacco material by conventional heating of Claim 20
It would further have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of modified Fujisawa to also include the injection of steam having a steam temperature of between 102o C and 160o C into the container 11 of Fujisawa in as taught by Anizon. One of ordinary skill in the art would have a reasonable expectation of success in making said modification because Anizon teaches an extraction heating process for a biological material, such as the tobacco material of Fujisawa, that includes both steam injection into a chamber to heat the biological material and heating the biological material by microwave irradiation of the biological material inside the chamber, reading over heating the tobacco material comprises heating the tobacco material by a combination of microwave heating and conventional heating of Claim 20.
Regarding claim 24, modified Fujisawa discloses all the claim limitations as set forth above. Modified Fujisawa does not explicitly disclose continuous circulation of the tobacco material during microwave heating.
Anizon teaches with reference to Fig. 1, the enclosure 1 is also equipped with agitation means 11, consisting of a three-bladed turbine, allowing the biological material to be agitated (reads over continuously circulated) during its presence inside the enclosure 1, when it is subjected to the action of the microwaves and prevents certain areas of it from being insufficiently irradiated to carry out the extraction operation (description pg 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of modified Fujisawa to include mechanical agitation of the tobacco material during microwave irradiation as taught by Anizon. One of ordinary skill in the art would have a reasonable expectation of success in making said modification as Anizon teaches agitation of the biological material while the biological material is under the action of the microwaves prevents areas of the biological material from being insufficiently irradiated by the microwaves during the extraction operation. This reads over the circulation limitation of Claim 24.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONNIE KIRBY JORDAN whose telephone number is 571-272-5214. The examiner can normally be reached M-F 8AM - 4PM (EST).
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/RONNIE KIRBY JORDAN/Examiner, Art Unit 1747
/Christopher M Rodd/Primary Examiner, Art Unit 1766
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