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 .
This office action is in response to the reply filed 4/20/2026.
Election/Restrictions
Claims 6-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/4/2025.
Response to Arguments
All of Applicant’s arguments filed 4/20/2026 have been fully considered.
Specification
Applicant’s amendments to the specification are accepted and the objection is withdrawn.
101 Rejection
Applicant argues that the office action does not identify a proper naturally occurring counterpart for the claimed subject matter.
This is not persuasive as the examiner states that the claims are drawn to mixtures of naturally occurring products, as such as the natural occurring counterparts is the mixture of these three component which do occur together naturally.
Applicant argues that the office has provided no evidence that Citrus depressa peels, in their natural state, inherently contain hesperidin, nobiletin and isosinensetin in the claimed dry extract percentage.
This is not persuasive. A 101 rejection is not based on whether the Citrus depressa peels in their natural state have the claimed components in the claimed amounts. The rejection is based on whether extraction has caused the components of Citrus depressa peels to have any characteristics that are different from the naturally occurring components in Citrus depressa peels. In other words, the components in the extract of claim 1 exist naturally in the Citrus depressa peels plant material before the extraction starts. Extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. While the alcoholic extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Regarding the claimed concentration, while these ranges are not found in nature, altering the concentration of the claimed ingredients does not appear to change its structure or function and therefore does not appear to result in a markedly different characteristic for the composition.
Applicant argues that the specification, example 1 and Fig. 1, as filed shows the extract to have a distinct biological property, a specific and unexpected activity.
This is not persuasive as the data presented simply shows a property of the claimed extract and there is no comparison with the naturally occurring counterpart (i.e. extracts of hesperidin, nobiletin and isosinensetin individually). In order to show an unexpected effect there must be comparative data. Applicant must demonstrate that the claimed extract in the claimed amounts has a markedly distinct property by showing that the claimed ranges are critical for achieving this distinct biological property. The data presented by Applicant must also be commensurate in scope with the instant claims.
Applicant argues that the limitations of claims 3-5 are meaningful limitations directed to specific human-made products and not to a naturally occurring counter substance in nature.
This is not persuasive, because the claims do not include additional elements that are sufficient to amount significantly more than the judicial exception because the claimed do not recite any additional elements beyond the claimed composition themselves. There are no structural limitations in claims 3-5 in addition to the extract containing naturally occurring ingredients. Regarding the weight ratio in claim 3, altering the concentration of the claimed ingredients does not appear to change its structure or function and therefore does not appear to result in a markedly different characteristic for the composition.
Regarding claim 4-5, the placement of these ingredients into a cosmetic composition does not add a meaningful limitation and simply links the product of nature to a particular technological environment. Furthermore, as demonstrated the art cited below, it is well-understood and conventional to combine the claimed extracts into cosmetic formulations. Therefore, the claims are drawn to judicial exceptions.
112 Rejections
The amendments to the claims were sufficient to overcome the issues noted in the previous office action, as such the 112 rejections previously presented are withdrawn.
103 Rejections
In summary, Applicant argues that the office action alleges but provides no evidence showing that the ethanolic extract of Lee comprises a mixture of hesperidin, nobiletin and isosinensetin.
This is not persuasive. The office action demonstrates that the ethanolic extract of Lee comprises hesperidin and nobiletin. Lee further teaches that methanol can be added to the extraction as a co-solvent. Brits teaches that isosinensetin is obtained when extracting Citrus depressa peels with methanol. Therefore, the use of both methanol and ethanol as the extraction solvent in the extraction method of Lee, as made obvious in the rejection, is expected to result in a mixture comprising hesperidin, nobiletin and isosinensetin. This expectation is supported by the teachings of Lee and Brits.
Applicant argues that the prior art shows that any variation in the extraction process has a strong impact on the molecules obtained in the final extract.
While this is true, both Lee and the specification teach the same steps of obtaining an extract, a) grinding dried peels into a powder, extraction from the peels using ethanol at 60°C, sieving the extract to collect peel residue and setting aside the extract and then b) the peel residue is then subjected to extraction again with ethanol. The extract resulting from a and b are combined. Lee then teaches that extract to be concentrated and dried, while the instant spec discusses additional steps such as filtering the extract, concentrating the extract, distilling it, etc. The initial steps of obtaining the extract are performed with the same solvents at the same temperature, as such the same components are expected to be in the concentrated extract of Lee.
Applicant argues that the prior art does not teach the extract to be used as a powerful ingredient for preventing excessive desquamation.
This is not persuasive, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant remarks that there is no motivation to combine the teaching of Brits and Lee and without such motivation and absent improper hindsight a skilled artisan would not be motivated to perform the proposed modification.
This is not persuasive as the motivation comes from the Lee reference itself which teaches that methanol can be used as a co-solvent. This teachings enables a skilled artisan to be motivated to create an extract using a mixture of solvents such as ethanol and methanol with a reasonable expectation of success. As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Maintained Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 3-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural composition of matter without significantly more.
Claim 1 recites an alcoholic extract of Citrus depressa peels containing a mixture of hesperidin, nobiletin and isosinensetin as the only extract in a specified concentration range. Claim 3 recites the weight ratio in which the hesperidin, nobiletin and isosinensetin are present in the extract with respect to each other. Claim 4 a recites cosmetic formulation comprising the extract of claim 1 as the only active ingredient and a cosmetically or pharmaceutically acceptable medium. Claim 5 is drawn to the cosmetic formulated for topical administration.
These instantly claimed limitations are drawn to a product of nature, namely naturally occurring compounds found in Citrus depressa peels. Citrus depressa peels contain the instantly claimed hesperidin, nobiletin and isosinensetin (see Brits 2021, table 1, NR 12 and 23; and Lee 2010, Fig 9).
Extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. While the alcoholic extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, a claim to a solvent extract would tie up and monopolize a subset of compounds that are naturally present in the plant and are simply soluble in the selected solvent. Thus, the instantly claimed extract of Citrus depressa and the compounds claimed that are naturally found in Citrus depressa do not amount to an exception of the judicial exception, because isolation or purification does not result in a product which is ‘markedly different’ from the naturally-occurring component. Thus, while extraction of the compounds with the selected solvent (water and alcohol) would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Please note that in Myriad, excising DNA to isolate the DNA from its natural source did not constitute a product which was “markedly different” from the naturally occurring DNA even though the excised ends of the DNA were different in structure when compared to native DNA.
Thus, the claims are drawn to mixtures of naturally occurring products. Therefore, the claims are drawn to judicial exceptions. There are no structural limitations in claims 2-5 in addition to the extract containing naturally occurring ingredients.
Regarding claims 2-3: Regarding the claimed amounts, altering the concentration of the claimed ingredients does not appear to change its structure or function and therefore does not appear to result in a markedly different characteristic for the composition.
Regarding claim 4-5: The placement of these ingredients into a cosmetic composition does not add a meaningful limitation and simply links the product of nature to a particular technological environment. Furthermore, as demonstrated the art cited below, it is well-understood and conventional to combine the claimed extracts into cosmetic formulations. Therefore, the claims are drawn to judicial exceptions.
Maintained 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.
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.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (2010) and Brits (2021).
Lee discusses the extraction of compounds of Citrus depressa. The peels of Citrus depressa were separated and dried by freeze drying, then milled and stored in dessicators. The pulverized sample was extracted with aqueous ethanol by ultrasonic shaking for 4h at 60°C, the crude extract was filtered and the residue was extracted two more mores with the same solvent by ultrasonic shaking. The combination of the three extracts were concentrated and dried by vacuum (pg. 60). Fig 9 shows this extraction (conventional extraction) to comprise nobiletin and hesperidin, amongst other compounds.
Lee does not teach the extract to comprise isosinensetin, but does teach that co-solvents such as methanol can be added.
The originally filed specification, example 1, teaches that the extract as claimed can be obtained by a) grinding dried peels into a powder, extraction from the peels using ethanol at 60°C, sieving the extract to collect peel residue and setting aside the extract and then b) the peel residue is then subjected to extraction again with ethanol. The extract resulting from a and b are combined. The originally filed specification teaches that methanol is also a suitable extraction solvent.
Britts teaches an extraction method of Citrus depressa peels wherein the dried powder was extracted with methanol and the sample was centrifuged, the supernatant was removed and the extraction was repeated twice on the residue. The resulting extracts were combined. The resultant extract contained isosinensetin and nobiletin (pg. 1083 and table 1).
As discussed above, Lee teaches a very similar extraction step of dried Citrus depressa peels with ethanol results in an extract comprising nobiletin and hesperidin. Lee also teaches that methanol can be used as a cosolvent and this type of solvent can be added as a modifier to enhance the extraction of polar compounds, thus it would be obvious to use this in combination with ethanol. While Lee does not teach the extract to further comprise isosinensetin, this compound is expected to be present in the extract of Lee using both ethanol and methanol as solvents as the extract of Lee is prepared in a manner similar to the claimed extract using the same extraction solvents and the subsequent steps of filtering the initial extract and extracting the residue again. This is supported by Brits who demonstrates that isosinensetin can be extracted from citrus depressa peels with methanol.
Regarding claim 1 and 3: While Lee doesn’t teach the claimed wt% and weight ratios of nobiletin, isosinensetin and hesperidin, Lee teaches that polar solvents can be used to enhance extraction of polar compounds and other peaks appears when using co-solvents and further teaches that increasing the percentage of water in ethanol affects the yield of compounds such as nobiletin and tangeretin. This is due to higher water content is associated with increased polarity of the modifier, which enables the slightly polar nobiletin and tangeretin to be extracted more readily (pg. 61). As Lee teaches that the extraction method and selection of solvents (i.e., alcohols and/or water) can affect the types of compound extracted and their yields, a skilled artisan would have been able to modify the extraction method to obtain a desired concentration of specific compounds. MPEP 2144.05 II: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)"
Claim(s) 1, 3 and 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (2010) and Brits (2021), as applied to claims 1 and 3 above, and further in view of KR’20120043288. KR’288 is cited on the 9/15/2023 IDS. The Examiner has provided a copy of the machine translation of the KR’288 translation relied upon below.
As discussed above, Lee and Brit makes obvious an aqueous extract of citrus depressa peels comprising containing a mixture of hesperidin, nobiletin and isosinensetin, however, they do not teach the extract to be present in a cosmetic composition.
KR’288 discloses a cosmetic composition comprising a citrus depressa extract as the active ingredient (Abs).
Regarding claims 4-5: The cosmetic is applied topically to the skin and comprises water as the carrier (see working examples). KR’288 teaches that the extract can be obtained by using conventional methods in the art such as by leaching, purifying and separating in water or organic solvents such as ethanol and methanol (pg. 6).
It would have been prima facie obvious to a person or ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the prior art and use the citrus depressa peel extract taught of Lee and Brit in the cosmetic of KR’288 as KR’288 teaches that extracts of methanol and ethanol can be effectively used and its prima facie obvious to pursue the known options within the technical grasp of a skilled artisan to formulate a cosmetic comprising an extract. One of skill in the art would have a reasonable expectation of success as both Lee and KR’288 teach using citrus depressa extracted with alcohols such as ethanol and methanol.
Conclusion
No claims are allowable.
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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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