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 .
Status of the Claims
Claims 1-17 are pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 5: “group consisting of ethyl acetate and ethanol, and a mixture of ethyl
acetate and ethanol” should read “group consisting of ethyl acetate, ethanol, and a mixture of ethyl acetate and ethanol.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 10 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 9 is indefinite for reciting “the ratio of ethyl acetate to ethanol is between 1 to 0 and 0 to 1”. It is unclear to what measurement the ratio-level refers to. It is not clear if the ratio is based on weight, volume, or molar mass. The specification appears to disclose that the amounts are based on weight. Therefore, for the purposes of examination, the ratio within the claims is being interpreted as ratio by weight.
Claim 10 is indefinite for reciting “the ratio of ethyl acetate to ethanol is 1 to 1”. It is unclear to what measurement the ratio-level refers to. It is not clear if the ratio is based on weight, volume, or molar mass. The specification appears to disclose that the amounts are based on weight. Therefore, for the purposes of examination, the ratio within the claims is being interpreted as ratio by weight.
Claim 17 recites “a concentrated bolder, but less sweet, flavor.” It is not clear as to what a bolder flavor refers to. “Bolder flavor” is a vague description that is subjective and a relative term of degree. The specification appears to disclose bolder as “jam-like” flavor. For the purposes of examination, the claim limitation is being interpreted as “a concentrated jam-like but less sweet flavor”.
Claim Rejections - 35 USC § 103
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 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 1-4, 6-7, 9-10, 12-13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chida et al. (US20200359672A1 hereinafter referred to as Chida ‘672) in view of Randhava et al. (US20130197249A1 hereinafter referred to as “Randhava ‘249”)
Regarding Claim 1, Chida ‘672 directed to a method for producing tobacco extract non-combustion type flavor inhaler (Abstract), teaches extracting tobacco flavors from tobacco plant material (tobacco leaf; (Abstract), [0043] comprises; immersing a tobacco material in a solvent ([0047]; [0052]);
wherein the solvent is selected from a group consisting of ethyl acetate (Fig. 5, [0047]) and ethanol (Fig. 10, [0052]).
Chida ‘672 does not explicitly disclose using food grade solvents.
Randhava ‘249 directed to extraction methods of oil from a feedstock, discloses extraction of a feedstock material (“plant material” [0032]- [0033]) using food grade solvents including ethyl acetate and ethanol ([0026]- [0027]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Chida ‘672 by utilizing food grade solvents as taught by Randhava ‘249 because both Chida ‘672 and Randhava ‘249 are directed to extraction methods of a plant material using organic solvents, Randhava ‘249 teaches using food grade solvents that are GRAS ( Generally Recognized as Safe) ensuring human safety, regulatory compliance, and this involves substituting a standard solvent for a food grade solvent to yield predictable results.
Regarding Claim 2, modified Chida ‘672 discloses the food grade solvent is only ethyl acetate ([0047]; Fig. 5)
Regarding Claim 3, modified Chida ‘672 discloses the food grade solvent is only ethanol ([0052]; Fig. 10)
Regarding claim 4, modified Chida ‘672 discloses solvents used as ethyl acetate and ethanol but doesn’t explicitly disclose a solvent mixture of ethyl acetate and ethanol.
Randhava ‘249 discloses that the food grade solvent used is a mixture of ethyl acetate and ethanol, blend B, ([0005]; [0017] – [0019]; [0066]- [0067]; [0082]). Randhava ‘249 further discloses that mixture of ethanol into ethyl acetate, blend B, significantly increase the oil extraction properties of food grade solvents ([0021]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Chida ‘672 by mixing food grade ethyl acetate and ethanol solvents of Chida ‘672 to make a solvent mixture of ethyl lactate and ethanol as taught by Randhava ‘249 because both Chida ‘672 and Randhava ‘249 are directed to extraction methods of a plant material using solvents, Randhava ‘249 teaches using a solvent mixture of ethyl acetate and ethanol, blend B, to determine the effectiveness in extracting the desired end product, and this involves applying a known solvent mixture to a similar solvent extraction method to yield predictable results.
Regarding claim 6, modified Chida ‘672 discloses the food grade solvent is at room temperature, “extraction was performed at room temperature” [0139].
Regarding claim 7, modified Chida ‘672 discloses the food grade solvent is at room temperature, but does not explicitly disclose heating the solvent to about 60 degrees Celsius.
Randhava ‘249 discloses the food grade solvent is heated at a controlled temperature ranging from 20 to 90 degrees Celsius, (“temperature during an extraction process may be about 60 degrees Celsius” [0035]). The temperature range disclosed by the prior art overlaps the claimed range of the food grade solvent heated to about 60 degrees Celsius and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to further modify the food grade solvent of modified Chida ‘672 by heating it to about 60 degrees Celsius as taught by Randhava ‘249, because both Chida ‘672 and Randhava ‘249 are directed to extraction methods of a plant material using solvents, Randhava ‘249 teaches heating the food grade solvent in order to study the effectiveness of temperature upon solvent extraction process, and this involves applying a known extraction temperature to a similar extraction method to yield predictable results.
Regarding claim 9 and 10, Chida ‘672 discloses the ratio of ethyl acetate to ethanol is 1 to 0 (“solvent extraction with ethyl acetate” ([0047]; Fig. 5)) and 0 to 1 (“solvent extraction with ethanol” ([0052]; Fig. 10).
Chida ‘672 doesn’t explicitly disclose a mixture of ethyl acetate and ethanol in ratio between 1 to 0 and 0 to 1 and 1 to 1.
Randhava ‘249 discloses ratio of ethyl acetate to ethanol in different proportion “the blend of ethyl acetate and ethanol may have any proportion or combination of ethyl acetate and ethanol” [0047].
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify modified Chida ‘672 by providing a solvent mixture in ratio of ethyl acetate to ethanol between 1 to 0 and 0 to 1 by weight as taught by Randhava ‘249 because both Chida ‘672 and Randhava ‘249 are directed to extraction methods of a plant material using solvents, Randhava ‘249 teaches any solvent mixture which would result in combinations that have a ratio between 1 to 0 and 0 to 1 and 1 to 1 in order to maximize the extraction of a desired end product, and this involves applying a known solvent combination ratio to a similar solvent extraction method to yield predictable results. .
Regarding Claim 12, Chida ‘672 discloses the steps of solvent extraction resulting in an extract that is a liquid having an aqueous phase and further transformed into anhydrous extract ([0043]).
Regarding the limitation “liquid”, Chida ‘672 discloses solvent-immersed extraction of tobacco leaf in ethyl acetate ([0047]) and ethanol ([0052]) produces a liquid extract as the direct result of dissolving tobacco flavor compounds into a liquid organic solvent. A liquid solvent carrying dissolved compounds is by definition a liquid.
Regarding the limitation “anhydrous character” (i.e., water-free), is disclosed by Chida ‘672 using only ethyl acetate ([0047]) or only ethanol ([0052]) extraction embodiments show no added water to the extraction system. As a result, the extract recovered from the organic phase contains no added water.
Regarding the limitation “aqueous character” is not defined in the instant specification. Reading the term in light of the extracted compound list disclosed therein, the broadest reasonable interpretation of this limitation is mobile, low-viscosity, clear liquid extract. Both ethyl acetate and ethanol are clear, colorless to light-amber, low-viscosity liquids at ambient conditions. A dilute solution of tobacco flavor compounds in either solvent is likewise clear, mobile, low-viscosity liquid that is a characteristic of aqueous extract. This is an inherent physical character of any dilute organic extract that follows the same extraction steps with the same materials as claimed and requires no inventive step, absent evidence to the contrary
Regarding Claim 13, Chida ‘672 discloses that the method is carried out without addition of any water to the food grade solvent. In one embodiment, the extraction method is carried out using only ethanol solvent ([0052]; FIG. 10) and in another embodiment, the extraction method is carried out using only ethyl acetate solvent in the extraction step ([0047]; FIG. 5).
Regarding claim 15 and 16, modified Chida ‘672 discloses a method of tobacco flavor extraction using food grade solvents without addition of any hydrocarbon solvent, and without the addition of any of hexane or toluene or dichloroethane or chloroform or isopropanol or methanol ([0096]). Chida ‘672 further discloses an extraction method carried out using only ethanol solvent ([0052]; FIG. 10) and in another embodiment, Chida ‘672 discloses an extraction method carried out using only ethyl acetate solvent in the extraction step ([0047]; FIG. 10).
Regarding claim 17, modified Chida ‘672 discloses that the food grade solvent is at least partially evaporated, “ethyl acetate is removed under reduced pressure” ([0043]; FIG.1), furthermore Chida ‘672 discloses step 3 of solvent removal ([0023]), which is carried out under reduced pressure with an evaporator [0097]), and the resultant tobacco extract is dried and solidified (i.e., concentrated) ([0097]; [0139]). Chida ’672’s evaporation method is complete solvent removal, which necessarily encompasses the claimed “at least partial” evaporation method.
Chida ‘672 does not explicitly disclose the resultant extract has a concentrated woody, jam-like but less sweet flavor.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to recognize that modified Chida’s extraction method started with the same starting material (tobacco leaves, ethanol and ethyl acetate) and follows the same steps as claimed, that you would get a similar extract with a concentrated jam-like, but less sweet, flavor. In regards to the limitation “a jam-like concentrated flavor” of the extract after evaporation is a direct inherent result of increasing concentration of dissolved tobacco flavor compounds by removing the bulk of the solvent carrier as taught by Chida ‘672. In regards to the limitation “less sweet flavor” after evaporation is the direct and inherent result of removing sweet flavored solvents from the extract. This result follows directly and predictably from the known flavor chemistry of ethyl acetate and ethanol that requires no inventive step, absent evidence to the contrary.
Claims 5, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chida ‘672 in view of Randhava ‘249 as applied to claim 1 above, and further in view of Qu et al. (CN104138028A hereinafter referred to the English Translated provided, referred to as “Qu ‘028”)
Regarding claim 5, Chida ‘672 discloses subjecting tobacco material to solvent immersion ([0047]; [0052]).
However, Chida ‘672 does not explicitly disclose tobacco material is immersed for thirty minutes or less.
Qu ‘028 directed to a method for extracting tobacco aroma components ([0009]), discloses tobacco material (“tobacco leaves” [0017]) extraction using solvents such as ethanol. Qu ‘028 further discloses tobacco material in solvent immersion time is 5-20 minutes ([0022]). The range disclosed by the prior art overlaps the claimed range of tobacco material immersed for thirty minutes or less and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Chida ‘672 by carrying out solvent extraction for 5 to 20 minutes as taught by Qu ‘028 because both Chida ‘998 and Qu ‘028 are directed to solvent extraction methods of tobacco material, Chida ‘672 is silent in regards to the tobacco material in solvent immersion time, one of ordinary skill would look to a similar reference for a known suitable solvent immersion time interval as Qu ‘028, and this merely involves applying a known amount of immersion time to a similar process to yield predictable results.
Regarding claim 11, modified Chida ‘672 discloses the food grade solvent is ethanol ([0052]; FIG. 10) but does not appear to disclose ethanol is 200 proof.
Qu ‘028 directed to a method for extracting tobacco aroma components ([0009]), discloses that 200 proof ethanol can be used for extraction (anhydrous ethanol; [0076]; [0096]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the ethanol of Chida ‘672 by substituting it with 200 proof ethanol as taught by Qu ‘028 because both Chida ‘998 and Qu are directed to extraction methods from tobacco material using solvents, Chida ‘672 is silent in regards to the purity of ethanol used, one of ordinary skill would look to a similar reference for a known pure ethanol solvent as Qu ‘028, and this merely involves substituting a known solvent for another to yield predictable results.
Regarding claim 14, modified Chida ‘672 discloses composition of tobacco material with food grade solvent but does not appear to explicitly disclose the ratio of the tobacco material to the food grade solvent as 1 to 8, by weight.
Qu ‘028 directed to a method for extracting tobacco aroma components ([0009]), discloses tobacco material-to-solvent ratios of 1:10 to 1:25 by weight “the mass of the extraction solvent added is 10-25 times the mass of the tobacco shreds or leaves” [0020]. The range disclosed by the prior art overlaps the claimed range of tobacco material to food grade solvent 1 to 8 and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the tobacco material-solvent composition of Chida ‘672 to have a composition ratio of tobacco material-to-solvent ratios of 1:10 to 1:25 by weight as taught by Qu ‘028 because both Chida ‘998 and Qu are directed to extraction methods from tobacco material using solvents, Chida ‘672 is silent in regards to a composition ratio by weight of tobacco material to the solvent used, one of ordinary skill would look to a similar reference for known ratios of tobacco-solvent composition by weight such as Qu ‘028 , and this merely involves applying a known teaching to a similar method to yield predictable results.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chida ‘672 in view of Randhava ‘249 as applied to claim 1 above, and further in view of Farokhi et al. (US2021362074A1)
Regarding claim 8, modified Chida ‘672 discloses food grade solvent extraction but does not disclose cooling the solvent to about 0 degree Celsius.
Farokhi directed to a method of extraction from a plant material using organic solvents ([0026]; [0064]), discloses “organic solvent is utilized at cold temperatures between 0° C. to −80° C” [0065]; [0069]. The temperature range disclosed by the prior art overlaps the claimed range of the food grade solvent cooled to about 0 degrees Celsius and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to further modify the food grade solvent of modified Chida ‘672 by cooling the solvent to 0 degrees Celsius as taught by Farokhi, because both Chida ‘672 and Farokhi are directed to extraction methods of a plant material using solvents, Farokhi teaches cooling the solvent results in a final extract with significantly less impurities and produces significantly more potent extracts, and this involves applying a known temperature to a similar extraction method to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Radulovic et al. (Journal of Essential Oil Research, Vol 18, pages 562-565, Sept-Oct 2006). , directed to a chemical composition of ether and ethyl acetate extracts of tobacco types (Abstract), discloses a method of extracting tobacco flavors from tobacco plant material by immersing tobacco material in an organic solvent such as ethyl acetate (“tobacco extracted in sealed vessels with 50ml ethyl acetate” see page 562, col. 2).
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/HELEN GHEBRESELASSIE/ Examiner, Art Unit 1755
/PHILIP Y LOUIE/ Supervisory Patent Examiner, Art Unit 1755
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