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 Claims
Claims 15-34 are pending. Claims 29-34 are withdrawn as being drawn to a non-elected invention or species, there being no linking or generic claim.
Claims 15-28 are examined on their merits.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Rejections Maintained
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 of this title, 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.
The rejection of claims 15-20 and 22-26 under 35 U.S.C. 103 as being unpatentable over Greve et al. EP 2621505 (8/7/2013) (8/2/2023 IDS) in view of Sugimoto et al. JPH05236877 (9/17/1993) (8/2/2023 IDS) is maintained.
Greve et al. (Greve) teaches a method for producing an at least substantially alcohol-free composition based on at least one plant extract by following the steps of providing the alcoholic , particularly ethanolic, plant extract and then removing the alcohol by means of membrane filtration.
Greve teaches that a common issue with plant extracts is that there is a large amount of alcohol in the extracts which is undesirable, so there is a need for a way to remove the alcohol. (See [0012]). Thus Greve teaches the step of providing at least one alcohol-containing plant extract as called for in instant claim 15.
Greve teaches that there is preferably at least 98 wt% plant extract that is not alcoholic is preserved or left after the procedure. (See [0112]). This leaves 2% or less amount of alcohol which overlaps with the less than 4% called for in instant claim 16, the less than 1.5% called for in instant claim 17 and the less than 5,000 ppm called for in instant claim 17. (See [0029], [0112]) Indeed, Greve expressly teaches that the amount of alcohol should be less than 5,000 ppm so that it is suitable as a medicament that can be administered to babies. (See [0112]). Greve teaches that its process is an efficient way of producing an at least substantially alcohol-free composition based on at least one plant extract, the resulting composition being suitable for the treatment of respiratory diseases such as colds and flu, etc. (See [0029]).
Greve teaches that the membrane filtration is undertaken at the temperature of 5 to 80 °Celsius which overlaps with the 5 – 60 °C called for in instant claim 25 and 26. (See Greve claim 10). Greve also teaches that the pressure difference is in the range of 10-100 bar and overlaps with the 5 to 80 bar called for in instant claims 24 and 26. (See Greve claim 7).
Greve also teaches that the steps are repeated in sub stages where water is added and the membrane filtration is conducted again. (See Greve claim 16). This reads on the retentate or composition after membrane filtration being diluted with water and put through the process steps again as called for in instant claim 19.
Greve does not teach a cyclodextrin. This deficiency is made up for with the teachings of Sugimoto et al.
Sugimoto et al. (Sugimoto) teaches the addition of cyclodextrin to hot water and green tea leaves are immersed in the hot water to extract a green tea component and the extract is filtered through a filter to remove sediment and filtered. (See Abstract and claim 1). Cyclodextrin is credited with retaining the scent and retaining the taste, aroma and flavor of green tea. (See [0011]). Sugimoto therefore teaches that the cyclodextrin has a protective effect on the extract and may prevent oxidation to a large degree. (See [0011]). In this way Sugimoto teaches that the cyclodextrin is a results-effective variable. As such, it would be no more than routine experimentation to experiment to arrive at the concentrations called for in instant claims 22 and 23.
Additionally, Sugimoto teaches that in order to concentrate the green tea extract, two kinds of concentration treatments, ultrafiltration and reverse osmosis are carried out and the main components of green tea are concentrated. (See [0011]).
With the reverse osmosis treatment the components of the green tea are dissolved in the permeation liquid of the ultrafiltration membrane. This method has the advantage that the components of the green tea can be concentrated without damaging them. In this way the extract is ultrafiltered and the permeate is subjected to reverse osmosis to completely secure the contents of the green tea and concentrate. (See Example Figure 1 and [0012-14].
In Example 1 the green tea leaves were soaked in hot water to extract the tea component. This extract was filtered using a filter cloth having an opening 1 micrometers to remove coarse tea pieces and other sediments. The extract was recovered. Next the solution was first ultrafiltered using an ultrafiltration membrane having a pores of 40 to 80 ohm to recover the first concentrated solution. This permeate was passed through a reverse osmosis membrane with a pore size of 10 ohm and the concentrate was collected. This reverse osmosis membrane filtration is called for in instant claim 26. The first concentrated liquid obtained by ultrafiltration and the second concentrated solution obtained by reverse osmosis were mixed together to obtain the concentrated green tea which was then packaged. The concentrate can then be diluted with water to form a green tea beverage. (See Example 1).
It would have been prima facie obvious for one of ordinary skill in the art as of the earliest effective filing date following the Greve process to complex the plant extract with cyclodextrin in order to remove the alcohol while stabilizing and protecting the plant extract components as taught by Sugimoto.
The rejection of claims 21 and 27-28 under 35 U.S.C. 103 as being unpatentable over Greve et al. EP 2621505 (8/7/2013)(2/2/2022 IDS) in view of Sugimoto et al. JPH05236877 (9/17/1993)(2/2/2022 IDS) as applied to claims 15-20 and further in view of Ma et al. Inclusion complex of volatile oil from Thymus mongolicus Ronn. With hydroxypropyl-β-cyclodextrin, Science and Technology of Food Industry, 2013, pp 1-5. (8/2/2023 IDS) is maintained.
The teachings of Greve in view of Sugimoto are described supra. Greve in view of Sugimoto do not teach a plant extract from the genus Thymus. This deficiency is made up for with the teachings of Ma et al.
Ma et al. (Ma) teaches methods to optimize the hydroxypropyl-β-cyclodextrin inclusion technology of volatile oil from Thymus mongolicus. An aqueous solution stirring method was used to prepare the inclusion complex. (See Abstract). The stabilities of the volatile oil were increased following the complexation with hydroxypropyl-β-cyclodextrin and the main chemical components of thymus oil did not change before and after complexation with hydroxypropyl-β-cyclodextrin. (See Abstract). MA teaches that the method conditions were reasonable, stable and feasible. (See Abstract). Hydroxypropyl-β-cyclodextrin is called for in instant claim 21. A plant extract from the genus Thymus is called for in instant claims 27-28.
It would have been prima facie obvious for one of ordinary skill in the art as of the earliest effective filing date following the Greve in view of Sugimoto method to use hydroxypropyl-β-cyclodextrin to complex with a plant extract volatile oil from Thymus mongolicus taught in Ma in order to have a method of increasing the stabilities of the volatile Thymus genus oil in a method whose conditions are taught by Ma to be reasonable, stable and feasible.
Response to Arguments
Applicants’ comments of August 22, 2025 have been fully reviewed and are found to be unpersuasive.
Applicants assert that the prior art of Greve and Sugimoto does not teach the invention recited in the claims.
Applicants assert that it was unexpected that the addition of cyclodextrin during removal of alcohol from an alcohol plant extract resulted in significantly increased amount of the plant extract in the retentate (rather than the permeate) regardless of alcohol percentage.
Applicants take issue with the Examiner’s assertion that the use of cyclodextrin may prevent oxidation to a large degree because Applicants assert that Sugimoto discloses that another component, ascorbic acid, is responsible for this effect. Applicants assert that preservation of aroma (which is an effect specifically ascribed to cyclodextrin) in tea is not a reason why the ordinary skilled artisan would look to incorporate cyclodextrin in an alcohol removal process form an alcohol plant extract.
Where the goal of the invention is to better preserve recovery of an alcohol extract plant material while reducing significantly the amount of alcohol, there is no reason the ordinarily skilled artisan would look to the Sugimoto reference for incorporation of cyclodextrin from a wholly unrelated process not even involving an alcohol extract. In short, Sugimoto would not be considered an analogous reference because there are two different fields of endeavor, Applicants assert. Greve deals with the field of alcohol removal from an alcohol-plant extract and Sugimoto relates to methods of concentrating tea in hot water while preserving the properties of the tea.
Applicants also assert that Ma does not rectify the deficiencies in the above rejection.
Applicants’ arguments have been carefully considered and are not found to be persuasive. Respectfully, Applicants’ argument that the preservation of aroma (which is an effect specifically ascribed to cyclodextrin) in tea is not a reason why the ordinary skilled artisan would look to incorporate cyclodextrin in an alcohol removal process form an alcohol plant extract is unpersuasive. Many essential oils used for perfuming are extracted from plant with alcohol. The preservation of aroma would be very important and highly motivating for one of ordinary skill in the art because the preservation of the perfume of an extract is very important for a plant extract. The preservation of aroma would also suggest that compounds important to aroma are preserved during the extraction process.
Respectfully, Applicants’ assertion that a person of ordinary skill in the art would not have been motivated relies entirely on attorney argument as to what a person of ordinary skill in the art would believe and be motivated by and does not cite any evidence to support it. This is an instance in which an Affidavit as to what the person of ordinary skill in the art would believe is important and attorney argument unsupported by evidence does not suffice. See MPEP Sec. 2145 (emphasis added): Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984), or otherwise presented during prosecution. See, e.g., MPEP §§ 714 to 716 et seq. However, arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
Applicants’ assertion that it was unexpected that that the addition of cyclodextrin during removal of alcohol from an alcohol plant extract resulted in increased amount of the plant extract is not found to be persuasive because it appears that the prior art does suggest that the use of cyclodextrin increases the amount of plant material extracted. If the aroma of a plant extract is better preserved when cyclodextrin is used, it suggests that the amount of plant extract is increased, since the aroma is higher with the use of cyclodextrin versus when cyclodextrin is not used. Therefore, the effect seems to be more suggested and expected rather than unexpected.
Applicants’ arguments that Greve and Sugimoto are not analogous art is not found to be persuasive. Both Greve and Sugimoto deal with plant extracts in solvents. Tea is simply a plant extract and the brewing process of tea is a membrane filtration of tea leaves with the solvent of hot water. Therefore, since they both relate to plant extracts and the membrane filtration of plants and plant extracts with different solvents used to extract the plant extracts, a person of ordinary skill in the art would have considered them to be analogous and would certainly have looked to the Sugimoto reference from the teachings of Greve.
Conclusion
Claims 15-28 are rejected.
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 SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
