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 Application
The Amendments and Remarks filed on 11/13/25 are acknowledged.
Claims 12-16 were previously cancelled.
Claims 9 and 18 were cancelled on 11/13/25.
Claims 1, 4, and 17 were amended.
Claims 1-8, 10-11, and 17 are pending and are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/06/25 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Response to Amendments/Arguments
Rejection of claims under 35 USC § 103
Applicant amended independent claims 1 and 17 to include the limitation of “extracting oil ingredients from citrus rind or pomace to obtain a byproduct prior to roasting the byproduct” and “wherein the byproduct of the citrus in step (1) is a byproduct obtained after extracting oil ingredients from the rind of a citrus,” respectively. In light of these amendments, Applicants’ arguments (Pages 6-7, filed 11/13/25) regarding the following rejections under 35 U.S.C. 103 have been fully considered and are persuasive.
Rejection of claims 1-2, 4, 8-11, and 17-18 under 35 U.S.C. 103 as being unpatentable over Park et al. (WO 2021/080393 A1 – English Translation – “Park”) in view of Sawamura et al. (JP H0598255 A – English Translation – “Sawamura”) and Aydeniz-Guneser (Ch. 12, Academic Press, Green Technology, Bioactive Compounds, Functionality, and Applications, 2020, Abstract)
Rejection of claims 3 and 5-7 under 35 U.S.C. 103 as being unpatentable over Park in view of Sawamura and Aydeniz-Guneser, in view of Ehrlich et al. (US 4,497,842 A - “Ehrlich”)
Since the prior art listed above does not teach or suggest the limitations regarding extracting oil ingredients from citrus rind or pomace to obtain a byproduct prior to roasting the byproduct, a new ground(s) of rejection is made by using a new supporting reference, Liu (CN 1 772 269 A – English Espacenet translation).
Since the new grounds of rejection were necessitated by Applicant’s amendment, this action is made FINAL.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
New Rejections Necessitated by Amendment
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 1-2, 4, 8, 10-11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO 2021/080393 A1 – English Translation – “Park”) in view of Liu (CN 1 772 269 A – English Espacenet translation), and Aydeniz-Guneser (Ch. 12, Academic Press, Green Technology, Bioactive Compounds, Functionality, and Applications, 2020, Abstract).
Instant claim 1 is drawn to a method for treating sleep disorder or insomnia, comprising administering to a patient in need thereof a composition comprising a roasted citrus peel extract as an active ingredient, wherein the roasted citrus peel extract is obtained from the steps of:
extracting oil ingredients from citrus rind or pomace to obtain a byproduct prior to roasting the byproduct;
roasting the byproduct to obtain a roasted citrus byproduct; and
extracting the roasted citrus byproduct with a C 1-6 lower alcohol or an aqueous solution;
thereby obtaining the roasted citrus peel extract.
Park teaches a composition for preventing or alleviating sleep disorders caused by caffeine, wherein the composition contains at least one of a Citrus limon (lemon) extract and a Citrus sinensis (orange) extract (claims 1-4 and 8-10). The lemon extract is a lemon peel extract (claim 2) and the orange extract is an orange peel extract (claim 3). The extract was extracted with alcohol (claim 4).
Park does not expressly teach (i) extracting oil ingredients from citrus rind or pomace to obtain a byproduct prior to roasting the byproduct, (ii) a C1-6 lower alcohol, or (iii) a roasted citrus byproduct.
Liu teaches a pharmaceutical composition including tangerine peel which is used for treating insomnia (Description – Page 8 - [0013]). The active ingredient of the pharmaceutical composition is prepared by the method including step a) cutting the dried tangerine peel into shreds ([0017] – [0018]). The volatile oil from the fine shreds of Citrus reticulata peel is extracted ([0019]). The residue after extracting the volatile oil is combined with ethanol and heated under reflux ([0020]).
Aydeniz-Guneser teaches that pretreatments such as conventional roasting prior to cold pressing processes have significant effects on oil yield, bioactive components (flavonoids, phenolic acids, tocols, and pigments), aromatics, and sensorial properties of obtained citrus peel oils (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition for preventing or alleviating sleep disorders caused by caffeine, wherein the composition contains at least one of a Citrus limon (lemon) peel extract and a Citrus sinensis (orange) peel extract prepared by extraction with alcohol, as taught by Park, in view of the process of preparing a pharmaceutical composition including tangerine peel which is used for treating insomnia, which includes the step of extracting oil from fine shreds of citrus peel, combining with ethanol and then heating to extract the citrus product, as taught by Liu, and the pretreatments such as conventional roasting prior to cold pressing processes that have significant effects on oil yield, bioactive components (flavonoids, phenolic acids, tocols, and pigments), aromatics, and sensorial properties of obtained citrus peel oils, as taught by Aydeniz-Guneser, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references teach the extraction of citrus peels and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Furthermore, the use of known technique (extracting oil from fine shreds of citrus peel, combining with ethanol and then heating to extract the citrus product - as taught by Liu, and pretreating the citrus peel by roasting – as taught by Aydeniz-Guneser) to improve similar methods (the method of citrus peel extraction – as taught by Park) in the same way is also obvious. MPEP 2141(III)(C).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of a method for treating sleep disorder or insomnia would have been obvious over the use of a composition for preventing or alleviating sleep disorders caused by caffeine, wherein the composition contains at least one of a Citrus limon (lemon) extract and a Citrus sinensis (orange) extract, as taught by Park (claims 1-4 and 8-10), and the pharmaceutical composition including tangerine peel which is used for treating insomnia (Description – Page 8 - [0013]), as taught by Liu.
Regarding instant claim 1, the limitation of administering to a patient in need thereof a composition comprising a roasted citrus peel extract as an active ingredient, wherein the roasted citrus peel extract is obtained by extracting oil ingredients from citrus rind or pomace to obtain a byproduct prior to roasting the byproduct; roasting the byproduct to obtain a roasted citrus byproduct; and extracting the roasted citrus byproduct with a C 1-6 lower alcohol or an aqueous solution would have been obvious over the composition containing at least one of a Citrus limon (lemon) extract and a Citrus sinensis (orange) extract (claims 1-4 and 8-10), wherein the lemon extract is a lemon peel extract (claim 2), the orange extract is an orange peel extract (claim 3), and the extract was extracted with alcohol (claim 4), as taught by Park, in view of the pharmaceutical composition prepared by the method including step a) cutting the dried tangerine peel into shreds ([0017] – [0018]), wherein the volatile oil from the fine shreds of Citrus reticulata peel is extracted ([0019]), and the residue after extracting the volatile oil is combined with ethanol and heated under reflux ([0020]), as taught by Liu, and pretreatments such as conventional roasting prior to cold pressing processes that have significant effects on oil yield, bioactive components (flavonoids, phenolic acids, tocols, and pigments), aromatics, and sensorial properties of obtained citrus peel oils (Abstract), as taught by Aydeniz-Guneser.
Regarding instant claim 2, the limitation of the citrus would have been obvious over the Citrus limon (lemon) extract and a Citrus sinensis (orange) extract, as taught by Park (claims 1-4 and 8-10), the Citrus reticulata (mandarin orange) ([0019]), as taught by Liu, and the lemon and orange (Abstract), as taught by Aydeniz-Guneser.
Regarding instant claim 4, the limitation of the lime peel extract would have been obvious over the key lime (Citrus aurantifolia) (Abstract), as taught by Aydeniz-Guneser.
Regarding instant claim 8, the limitation of a pharmaceutical composition would have been obvious over the pharmaceutical composition for preventing and treating sleep disorders caused by caffeine, comprising one or more of a lemon extract and an orange extract, as taught by Park (claims 8-10), and the pharmaceutical composition including tangerine peel which is used for treating insomnia (Description – Page 8 - [0013]), as taught by Liu.
Regarding instant claim 10, the limitation of increasing sleep duration would have been obvious over the improvement of sleep disorders caused by caffeine ([39] – Page 4/14), the composition that was confirmed to improve the reduction of sleep time due to caffeine and for improving insomnia ([48] – Page 5/14 and FIG. 6), as taught by Park, and the treatment of insomnia (Description – Page 8 - [0013]), as taught by Liu.
Regarding instant claim 11, the limitation of a powder, a granule, a tablet, a capsule or a beverage would have been obvious over the powder, granule, tablet, capsule or liquid form ([56] – Page 5/14), as taught by Park.
Regarding instant claim 17, the limitation of a method for preparing a citrus byproduct extract with enhanced effect of preventing or alleviating sleep disorder or insomnia would have been obvious over the use of a composition for preventing or alleviating sleep disorders caused by caffeine, wherein the composition contains at least one of a Citrus limon (lemon) extract and a Citrus sinensis (orange) extract, as taught by Park (claims 1-4 and 8-10). The limitations of the steps (1) – (4) would have been obvious over the steps taught by Park ([78]-[83] - Page 7/14), in view of the pharmaceutical composition prepared by the method including step a) cutting the dried tangerine peel into shreds ([0017] – [0018]), wherein the volatile oil from the fine shreds of Citrus reticulata peel is extracted ([0019]), and the residue after extracting the volatile oil is combined with ethanol and heated under reflux ([0020]), as taught by Liu, and pretreatments such as conventional roasting prior to cold pressing processes that have significant effects on oil yield, bioactive components (flavonoids, phenolic acids, tocols, and pigments), aromatics, and sensorial properties of obtained citrus peel oils (Abstract), as taught by Aydeniz-Guneser.
Claims 3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO 2021/080393 A1 – English Translation – “Park”) in view of Liu (CN 1 772 269 A – English Espacenet translation), and Aydeniz-Guneser (Ch. 12, Academic Press, Green Technology, Bioactive Compounds, Functionality, and Applications, 2020, Abstract) as applied to claims 1-2, 4, 8-11, and 17-18 above, in view of Ehrlich et al. (US 4,497,842 A - “Ehrlich”).
Instant claim 3 is drawn to the method according to claim 1, wherein the roasting is performed at 150-230°C for 5-20 minutes.
The teachings of Park, Liu, and Aydeniz-Guneser are discussed above.
Park, Liu, and Aydeniz-Guneser do not expressly teach the roasting temperature as recited in instant claim 3.
Ehrlich teaches a method of roasting orange peel and grapefruit peel at a temperature between 140°C – 160°C until the particles were brown and hard (Col. 5, lines 20-26). Ehrlich teaches the use of a distilled alcoholic beverage of about 70 to about 120 proof (calculated to be 35 vol % and 60 vol %) which is just the proper alcohol water ratio to dissolve the components which have to be removed from the roasted peel (Col. 3, lines 13-20 and claim 2), wherein any liquor can be used as the source of ethanol (Col. 4, lines 32-35). Example 2 discloses the use of 100 proof vodka (Col. 6, lines 10-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition for preventing or alleviating sleep disorders caused by caffeine, wherein the composition contains at least one of a Citrus limon (lemon) peel extract and a Citrus sinensis (orange) peel extract prepared by extraction with alcohol, as taught by Park, in view of the process of preparing a pharmaceutical composition including tangerine peel which is used for treating insomnia, which includes the step of extracting oil from fine shreds of citrus peel, combining with ethanol and then heating to extract the citrus product, as taught by Liu, and the pretreatments such as conventional roasting prior to cold pressing processes that have significant effects on oil yield, bioactive components (flavonoids, phenolic acids, tocols, and pigments), aromatics, and sensorial properties of obtained citrus peel oils, as taught by Aydeniz-Guneser, and the orange peel and grapefruit peel roasting temperature range of between 140°C – 160°C until the particles were brown and hard, as taught by Ehrlich, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references teach the extraction of citrus peels and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Furthermore, the roasting temperature range of between 140°C – 160°C until the particles were brown and hard, as taught by Ehrlich, overlaps and renders obvious the claimed range of 150-230°C, since MPEP 2144.05 states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 3, the limitation of the roasting performed at 150-230°C for 5-20 minutes would have been obvious over the method of roasting orange peel and grapefruit peel at a temperature between 140°C – 160°C until the particles were brown and hard (Col. 5, lines 20-26), as taught by Ehrlich. One of ordinary skill in the art would have found the recited time period of 5-20 minutes obvious over the teaching by Ehrlich based on the desired level of roasting.
Regarding instant claims 5 and 6, the limitation of extracting with 10-90 vol% methanol or ethanol (instant claim 5) and a 50-80 vol% ethanol aqueous solution (instant claim 6) would have been obvious over the use of 70 to about 120 proof, calculated to be 35 vol % and 60 vol % of ethanol, which is just the proper alcohol water ratio to dissolve the components which have to be removed from the roasted peel (Col. 3, lines 13-20, Col. 4, lines 32-35, Col. 6, lines 10-16, and claim 2), as taught by Ehrlich. Please see MPEP 2144.05 regarding the obviousness of overlapping ranges.
Regarding instant claim 7, the limitation of extracting at 10-80°C would have been obvious over the aqueous ethanol used to leach the particles at overlapping temperature ranges of about 40° to about 80° F (calculated to be 4.44°C - 26/67°C) (Col. 2, lines 38-40), at ambient temperature (Col. 2, lines 40-42), or at room temperature (which ranges from 20°C to 25°C) (Col. 4, lines 16-21), as taught by Ehrlich. Please see MPEP 2144.05.
Conclusion
No claims are allowed.
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 ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615