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 15-34 are pending.
Claims 15, 20, 21, 24, 26, 28-30, 32 and 34 have been withdrawn.
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not persuasive.
Applicant Argument A:
Regarding the first heating time, the Office Action relies on routine optimization, but the cited references do not establish that the first heating time in the claimed method is a result-effective variable in the context of the proposed combination. Digard provides no teaching that extending the first extraction to at least 90 minutes would improve Digard's process.
There is no teaching or suggestion in Digard that would have led the person of ordinary skill in the art to increase the duration of the first extraction step to at least 90 minutes. Digard's process is built around contacting tobacco with a supercritical extraction solvent in each extraction step. See Digard, p. 2, 11. 5-17. In the only example cited by the Examiner for the first extraction time, Digard maintains the first extraction conditions for 1 hour. See id., p. 10, 1. 6. Digard then performs the second extraction at higher pressure and for a longer time than the first extraction step to extract the maximum amount of nicotine. See id., p. 10, 11. 25-27. Thus, Digard points to a shorter first extraction followed by a longer second extraction, not to extending the first extraction to at least 90 minutes before applying an alkaline solution to residual tobacco material.
There is also no teaching or suggestion in Digard that would have motivated such a person to increase the duration of the first extraction step to at least 90 minutes. Digard's extraction conditions vary significantly from Applicant's claimed invention, as Digard requires that the tobacco is contacted with a supercritical extraction solvent. See Digard, p. 2, 11. 5-8. It would not have been routine optimization to increase the duration of Digard's first extraction step to at least 90 minutes absent some teaching or reasoned basis for doing so.
Further, contrary to the Examiner's assertions, Digard does not disclose the "general conditions" of a first extraction temperature hold time. Instead, Digard only discloses that the "first extraction conditions are maintained for 1 hour". Id., p. 10, 1. 6. There is no teaching or suggestion in Digard that would have motivated the person of ordinary skill in the art to modify the time length of the first extraction step, and certainly no suggestion or pointer towards increasing the first extraction length to be at least 90 minutes, as claimed. Digard actually teaches away from increasing the length of the first extraction step, because Digard suggests that a second extraction step must be completed at a higher pressure and for a longer time than the first extraction step in order to extract the maximum amount of nicotine. See id., p. 10, 11. 25-27.
Examiner Response A:
The Examiner respectfully disagrees. Digard does not disclose the first temperature heating time aside from providing one example (“Example 1”) in which the first temperature is held for an hour. This is just an example and does not teach away from the reference as a whole. The fact that Digard suggests that a second extraction step must be completed at a higher pressure and for a longer time than the first extraction step in order to extract the maximum amount of nicotine does not teach away from increasing the length of the first extraction step, it just means that the second extraction step must be completed at a higher pressure and for a longer time than the first extraction step.
The burden is on the Applicant to demonstrate that the claimed heating time (“at least 90 minutes”) is critical and has unexpected results. The Examiners position is that one would have been motivated to optimize the heating time motivated by the desire to optimize the tobacco extract composition and/or the physical properties of the tobacco extract composition (page 3, lines 4-6).
Applicant Argument B:
Fujisawa treats the tobacco raw material with alkali before the heating treatment. See Fujisawa, [0064]-[0068] and Fig. 4. Fujisawa then captures flavor constituents released during that heating treatment and later may wash the remaining tobacco raw material to remove impurity substances. That disclosure differs from claim 16, which first heats tobacco material for at least 90 minutes, forms a first liquid tobacco extract from volatile compounds released in that first heating step, then applies alkaline solution to the residual tobacco material, and then heats the alkalised residual tobacco material to form a second liquid tobacco extract. Fujisawa therefore does not teach applying alkaline solution to residual tobacco material left after a first extraction so that the alkalised residual tobacco material is subjected to a second extraction to form a second liquid tobacco extract.
Digard relates to a method of producing a tobacco extract that relies upon contacting tobacco with a supercritical extraction solvent. Tobacco is first contacted with an extraction solvent at a first temperature and pressure, before residual tobacco is contacted again with a supercritical extraction solvent. See id., p. 2, 11. 5-8 and 14-17, and claim 1, steps (a) and (d). After the first extraction step, residual tobacco solids are separated from the supercritical solvent prior to a second supercritical extraction.
Fujisawa is concerned with a method of selectively separating/reducing impurity components from tobacco to produce a tobacco raw material containing flavor constituents. See Fujisawa, [0003] and [0096]. Fujisawa's method requires raw tobacco be treated with an alkali prior to heating treatment. See id., [0067] and Fig. 4, S10. Fujisawa specifies that the remaining tobacco material is treated with a washing solvent. See id., [0083]. Fujisawa is concerned with removing "impurity substances remaining [in] the tobacco raw material 50"
after the tobacco heating step. Id., [0084]. Further, Fujisawa's method requires that the tobacco raw material be kept in a closed space, ensuring that vaporization or removal of flavor constituents is inhibited. See id., [0044] and [0100].
Accordingly, the proposed modification would not have yielded the method recited in at least Applicant's claim 16. The Examiner relied on Fujisawa for alkali treatment, but Fujisawa applies alkali before heating the starting tobacco raw material. Claim 16 instead recites applying alkaline solution after the first heating step, to the residual tobacco material from that heating step. The timing and substrate of the alkali treatment are therefore different. This distinction is material because Applicant's disclosure identifies the post-first- heating alkali treatment of residual tobacco material as the step that enables a second heating step to extract additional nicotine while leaving the first extraction focused on volatile flavor compounds.
Therefore, the person of ordinary skill in the art would be taught away from combining the alkali tobacco treatment step of Fujisawa with the method of Digard because the two documents treat tobacco for completely different reasons: Digard to extract nicotine and flavorants from tobacco in order to produce a liquid tobacco extract, and Fujisawa to create a tobacco raw material containing flavor constituents while removing impurities. The use of a supercritical solvent is clearly a key step in Digard's method. The person of ordinary skill in the art would not omit or modify this step without a clear teaching or suggestion to do so.
In addition, there is no teaching or suggestion in Fujisawa that would have motivated the person of ordinary skill in the art to incorporate the alkali treatment step into Digard's method, and certainly no teaching in Fujisawa regarding what advantage would be gained from alkali pretreatment. While Fujisawa treats raw tobacco to increase the pH of the tobacco raw material (see Fujisawa, [0064] to [0066]), Fujisawa is silent regarding the reason for such a treatment. The person of ordinary skill in the art would be deterred from randomly incorporating the alkali pretreatment step from Fujisawa without a clear indication or pointer regarding any potential benefit.
Even if Digard's method was combined with Fujisawa's alkali treatment, the person of ordinary skill in the art would not have been able to arrive at the claimed feature of alkali residual tobacco treatment because Fujisawa teaches that alkali be used to treat raw tobacco, not the residual tobacco as specifically recited in Applicant's claim 16.
Moreover, the proposed modification is not supported by the process conditions of the cited references. Digard relies on supercritical extraction solvent to extract tobacco components and describes the benefit of supercritical conditions in increasing solvent capacity and extraction efficiency. See Digard, p. 3, 11. 4-20 and p. 8, 11. 8-14. Fujisawa, in contrast, applies an aqueous alkaline substance to tobacco raw material before heating and then captures released flavor constituents outside the closed space. See Fujisawa, [0046], [0064]-[0068], and [0075]. The Examiner does not identify any teaching in Digard, Fujisawa, or Grubbs that would have led the person of ordinary skill in the art to interrupt Digard's supercritical two-step extraction process after the first extraction, apply an aqueous alkaline solution to the residual tobacco material, and then conduct a second heating step within the claimed temperature range to form the claimed second liquid tobacco extract.
Examiner Response B:
The Examiner respectfully disagrees. Digard teaches a two part process: the first part is forming the first liquid tobacco extract and the second part is taking the residual tobacco material from the first part and forming the second liquid tobacco extract comprising the collected volatile compounds, specifically nicotine. Fujisawa just teaches the second part, starting with tobacco material, and forming the second liquid tobacco extract comprising the collected volatile compounds, specifically nicotine. Fujisawa includes a step of applying an alkaline solution to the tobacco material, before heating, because, as evidenced by Grubbs, pretreatment of tobacco with an alkaline compound is effective in increasing the amount of extractable nicotine under the conditions of the extraction process (col. 2, lines 25-30).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the method of forming the second liquid tobacco extract from which nicotine is isolated disclosed in Digard for the method of forming the liquid tobacco extract from which nicotine is isolated which includes pretreatment with an alkaline solution as disclosed by Fujisawa, because, as evidenced by Grubbs, pretreatment of tobacco with an alkaline compound is effective in increasing the amount of extractable nicotine under the conditions of the extraction process (col. 2, lines 25-30).
The residual tobacco material from the first part is applied as the starting “raw tobacco material” of the second part. This is done because, as evidenced by Grubbs, pretreatment of tobacco with an alkaline compound is effective in increasing the amount of extractable nicotine under the conditions of the extraction process (col. 2, lines 25-30).
Applicant Argument C:
This reinforces the distinction between the cited references and claim 16: Fujisawa uses alkaline treatment before heating the initial tobacco raw material, whereas claim 16 recites alkaline treatment after the first heating step and on the residual tobacco material from that step.
Finally, Grubbs does not cure the deficiencies of Digard and Fujisawa. The Examiner relies on Grubbs as evidence that base pretreatment can increase extractable nicotine. But Grubbs describes that point in the context of its own extraction process, including pretreating
tobacco before extraction or adding a source of base during extraction. See Grubbs, col. 2, 11. 25-34 and col. 6, 11. 37-60. Grubbs does not teach the claimed sequence of first heating untreated tobacco for at least 90 minutes to form a first liquid tobacco extract, then applying alkaline solution to the residual tobacco material from that first heating step, and then heating the alkalized residual tobacco material to form a second liquid tobacco extract. In contrast, Grubbs criticizes a multi-step supercritical extraction process as expensive and time consuming, and states that prolonged handling of aroma components may adversely affect their properties. See id., col. 1, 1. 62 to col. 2, 1. 11. Grubbs therefore would not have provided a reason to modify Digard in the manner asserted by the Examiner to arrive at Applicant's claimed method.
Applicant's disclosure explains why the claimed order of steps matters. In the second aspect method, the first heating step extracts volatile compounds to form a first liquid tobacco extract, while the later alkaline treatment of the residual tobacco material enables the second heating step to extract a higher proportion of nicotine from that residual material. See Specification, p. 5, 1. 30 to p. 6, 1. 33. In other words, the alkaline treatment is not a generic alkali pretreatment borrowed from Fujisawa or Grubbs; it is applied after the first heating step to a different substrate (a residual tobacco material) and it serves a different role in the claimed two-extract process.
The claimed post-first-heating alkaline treatment of residual tobacco material also preserves the functional separation between the first and second heating steps. The first heating step forms the first liquid tobacco extract from volatile compounds released before the alkaline treatment. The second heating step then forms a second liquid tobacco extract from volatile compounds released from the alkalised residual tobacco material. Applicant's disclosure describes that this approach enables the second heating step to extract additional nicotine while the first extraction remains directed to desirable flavor compounds from the tobacco material. See Specification, p. 6, 11. 23-33. The cited combination does not teach or suggest this sequence, this substrate for alkali treatment, or this separation of functions between the first and second liquid tobacco extracts.
Examiner Response C:
The Examiner respectfully disagrees. Grubbs is not relied upon to teach the process; it is just relied upon to teach that pretreatment of tobacco with an alkaline compound is effective in increasing the amount of extractable nicotine under the conditions of the extraction process (col. 2, lines 25-30). The process steps are taught by the combined teaching of Digard and Fujisawa.
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.
Claim(s) 16-19, 22, 23, 25, 27, 31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Digard (WO2018210680) in view of Fujisawa (US20160360781), as evidenced by Grubbs (US5018540).
Regarding claim 16, Digard teaches a method of producing a liquid tobacco extract (abstract), the method comprising the steps of:
preparing a tobacco material (“pre-treatment of tobacco” on page 9, lines 15-28);
heating the tobacco material at a first extraction temperature of between 308-473K ( 34.85C- 199.85 C) (page 14, claim 5);
collecting volatile compounds released from the tobacco material during the heating step;
forming a first liquid tobacco extract comprising the collected volatile compounds from the tobacco material (page 2, steps (a)-(c) and page 6, lines 14-16);
applying a extraction solvent to the residual tobacco material from the heating step; heating the residual tobacco material at a second extraction temperature; collecting volatile compounds released from the residual tobacco material during the heating step; and forming a second liquid tobacco extract comprising the collected volatile compounds from the residual tobacco material (page 2, steps (d)-(f) and page 6, lines 14-16).
Digard fails to teach that the first extraction temperature is held for at least 90 minutes. It would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the heating time since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed heating time is critical and has unexpected results. In the present invention, one would have been motivated to optimize the heating time motivated by the desire to optimize the tobacco extract composition and/or the physical properties of the tobacco extract composition (page 3, lines 4-6).
Digard does not expressly teach applying an alkaline solution to the residual tobacco material from the heating step to produce an alkalized residual tobacco material and the second extraction temperature.
Fujisawa teaches a method of forming a liquid extract that contains nicotine ([0002],[0044],[0045]) which comprises applying an alkaline solution to tobacco material to produce an alkalized tobacco material ([0067]), heating the alkalized tobacco material at a temperature in the range from 80 C to 150 C ([0068]), collecting volatile compounds released from the alkalized tobacco material during the heating step; and forming a second liquid tobacco extract comprising the collected volatile compounds from the alkalized tobacco material ([0075]), which includes nicotine ([0044]-[0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the method of forming the second liquid tobacco extract from which nicotine is isolated disclosed in Digard for the method of forming the liquid tobacco extract from which nicotine is isolated which includes pretreatment with an alkaline solution as disclosed by Fujisawa, because, as evidenced by Grubbs, pretreatment of tobacco with an alkaline compound is effective in increasing the amount of extractable nicotine under the conditions of the extraction process (col. 2, lines 25-30).
Regarding claims 17 and 18, modified Digard teaches further comprising the step of isolating nicotine from the second liquid tobacco extract (Digard, page 2, lines 14-17 and page 3, lines 19-20) and combining at least a portion of the isolated nicotine from the second liquid tobacco extract with the first liquid tobacco extract (Digard, page 3, lines 22-25).
Regarding claim 19, modified Digard teaches that the tobacco material is heated in a flow of inert gas during at least one of the heating steps, specifically Fujisawa teaches inert gas during the heating of the residual tobacco after addition of an alkaline solution (Fujisawa, [0074]).
Regarding claims 22 and 23, modified Digard teaches that a pH of the alkalized tobacco material is from 8.9 to 9.7 (Fujisawa, [0066]).
Regarding claim 25, modified Digard teaches that the alkaline solution is sprayed onto the tobacco material (Digard, [0046]).
Modified Digard does not expressly teach that the tobacco material is continuously agitated during the spraying, however it would have been obvious for one of ordinary skill in the art at the time of filing to have continuously agitated the tobacco material while it was being sprayed with the alkaline solution to ensure that all of the tobacco material had even contact with the alkaline solution.
Regarding claim 27, modified Digard teaches that the water content of the alkalized tobacco material prior to the heating step is between 10 percent and 50 percent by weight (Digard, [0047]).
Regarding claim 31, modified Digard teaches further comprising the step of adding water into an extraction chamber during the heating steps (Digard, [0069]).
Modified Digard fails to teach adding the water by spraying atomized water. It would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize how the water is added since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that adding the water by spraying atomized water is critical and has unexpected results. In the present invention, one would have been motivated to optimize the method of adding water motivated by the desire to optimize the tobacco extract composition and/or the physical properties of the tobacco extract composition (page 3, lines 4-6).
Regarding claim 33, modified Digard teaches further comprising the step of drying or concentrating the collected volatile compounds (Digard, [0078]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANA B KRINKER whose telephone number is (571)270-7662. The examiner can normally be reached Monday, Wednesday, Thursday and Friday.
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YANA B. KRINKER
Examiner
Art Unit 1755
/YANA B KRINKER/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
