DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Receipt and consideration of Applicant’s amended claim set and Applicant’s arguments/remarks submitted on January 30, 2026 are acknowledged.
All rejections/objections not explicitly maintained in the instant office action have been withdrawn per Applicant’s claim amendments and/or persuasive arguments. Applicant’s claim amendments have necessitated new grounds of rejections set forth below.
Status of the Claims
Claims 1, 3-17, and 19-22 are pending and under consideration in this action. Claims 2 and 18 are cancelled. Claims 20-22 are newly added.
Change in Examiner
The examiner for your application in the USPTO has changed. Examiner Monica Shin can be reached at 571-272-7138.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 30, 2026 has been entered.
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 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring products without significantly more.
Claim 13 is directed to a citrus peel extract. The extraction is ultimately from a naturally occurring product (i.e., a citrus peel), and thus, the compounds making up the extract are also naturally occurring compounds. Furthermore, there is no indication in the instant specification that the compounds in the claimed extract would result in any characteristics (structural, functional, or otherwise) that are different from their respective naturally occurring counterparts.
Claims 14 and 15 are directed to compositions comprising the aforementioned citrus peel extract. Claims 14 and 15 as currently written do not require any additional components, and thus, for the reasons discussed above, also do not add significantly more to the judicial exception.
The judicial exception is not integrated into a practical application because the claims do not recite any meaningful elements to the naturally occurring compounds. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no indication in the specification that the claimed compositions of naturally occurring compounds have any characteristics (structural, functional, or otherwise) that are different from their respective naturally occurring counterparts.
Response to Arguments
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive.
(1) Applicant argues that the claimed steaming step amounts to significantly more than any alleged natural phenomenon.
With regards to Applicant’s argument (1), the traversal argument is not found persuasive. Claims 13-15 are directed to a citrus peel extract and compositions comprising said extract. Although the extract is a result of the extraction of a citrus peel that has undergone the steaming step recited in claim 1, the compounds found within the extract are all naturally occurring compounds (e.g., see claims 4 and 6). Thus, claims 13-15 are ultimately compositions comprising a combination of naturally occurring compounds. There is no indication in the instant specification that the compounds in the claimed extract in the extract would result in any characteristics (structural, functional, or otherwise) that are different from their respective naturally occurring counterparts.
The judicial exception is not integrated into a practical application because the claims do not recite any meaningful elements to the naturally occurring compounds. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no indication in the specification that the claimed compositions of naturally occurring compounds have any characteristics (structural, functional, or otherwise) that are different from their respective naturally occurring counterparts.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 is directed to the citrus peel extract prepared by the method of claim 1, and claims 14 and 15 are directed to compositions comprising said citrus peel extract of claim 13. Claims 12, 16, and 17 are directed to methods of using the citrus peel extract or a composition comprising said citrus peel extract. The method of claim 1 recites “extracting a citrus peel extract from the steamed citrus peel”. The instant claims as currently written are directed to encompass all chemicals found in extracts of steamed citrus peel and all possible combinations of chemicals that can be extracted from the steamed citrus peel. However, various parameters used in extraction methods determine what compounds are and are not present in the resulting extract.
As evidenced by, Lapornik et al. (Lapornik) (Journal of Food Engineering; published 2005), the solvent used and the extraction time, for example, are parameters that impact the components and amount of components found in the resulting extracts (abstract). In Lapornik’s Table 5, for example, extracting with different aqueous solvents (water, 70% ethanol, and 70% methanol) and varying the extraction time when using the same solvent (e.g. 1 hr in water vs. 12 hr in water) varied the anthocyanins found in grape mare extracts. For example, a 1 hour extraction in water showed no delphinidin in the resulting extract, while a 12 hour extraction in water had delphinidin present in the resulting extract; and a 1 hour extraction in water showed no delphinidin in the resulting extract, while a 1 hour extraction in 70% ethanol (aqueous ethanol) had delphinidin present in the resulting extract (pg.219).
Thus, the term “citrus peel extract” as claimed in the product/composition of claims 13-15, and which is used in the method of claims 12, 16, and 17, does not meet the written description provision of 35 U.S.C. 112(a) due to lacking chemical structural information for what the extract is or is not composed of. As discussed above, the instant claims are directed to encompass all chemicals found in extracts of steamed citrus peel and all possible combinations of chemicals that can be extracted from the steamed citrus peel. However, as evidenced by Lapornik above, varying the parameters of the extraction method (e.g. specific solvent used, extraction time) results in compositions comprising different components. Thus, the Specification provides insufficient written description to support the genus encompassed by the claims.
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 4 and 19 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 4 and 19 both recite the term “low-molecular” flavonoid aglycones. The term “low-molecular” is a subjective term, which does not appear to be defined in the instant Specification. It is unclear what molecular weights are and are not encompassed by the term “low-molecular”, and thus it is unclear what flavonoid aglycones are and are not encompassed by the claim. Thus, the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-11, 13-15, and 19-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (Lee) (LWT – Food Science and Technology; published Mar. 5, 2022).
Note: Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Lee discloses the application of a high-temperature steaming process at 120oC to enhance the benefits of the citrus peels (abstract). The high-temperature steaming process was developed to improve chemical composition and efficacy of the peels (p.11, Conclusion).
With regards to Claims 1, 9, 13-15, and 20, Lee discloses that seven citrus peels were moistened in advance for a favorable chemical reaction by heat and pressure without burning. The swollen peels were placed in a stainless-steel vessel. The vessel was closed tightly (reading on airtight container) and heated (high-temperature steaming under pressure) in an oven at 120oC for 2, 4, 8, and 12 hours. Thereafter, the steamed peels were spread on glass containers and dried at 40oC. Each dried sample were then ground into powder, and then extracted three times using 10 mL of methanol at 40oC for 60 min of sonication (p.2, 2.3. Pretreatment and extraction; p.4, col.1, para.1), thus resulting in a citrus peel extract.
Further regarding Claims 14 and 15, the claims recite an intended use of the citrus peel extract or the composition containing the citrus peel extract. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02. In the present case, there appears to be no structural difference between the claimed invention and the prior art, and the prior art disclosure does not include structures or otherwise that would preclude it from performing the claimed intended use. Thus, absent evidence to the contrary, the prior art structure is capable of performing the intended use, and therefore meets the claim.
With regards to Claims 3, 21, and 22, the citrus peels used were the peels of bitter orange (Citrus aurantium), grapefruit (Citrus paradisi), lemon (Citrus limonum), lime (Citrus aurantifolia), orange (Citrus sinensis), satsuma mandarin (Citrus unshiu), and yuzu (Citrus junos) (p.2, 2.1. Plant materials).
With regards to Claims 4 and 5, Lee discloses that with application of the high-temperature steaming process, flavonoid aglycones were significantly produced and peaked at 8 hours, and the furanocoumarins were reduced after 4 hours (abstract). Lee discloses that the aglycones were not detected in the untreated peels, and the total content increased significantly with treatment time in the treated peels, peaking at 8 hours. This increase was inversely correlated with the change in the content of the flavonoid glycosides because the aglycones occurred through hydrolysis of the flavonoid glycosides (p.5, col.1, para.3; p.8, Fig.4A and 4B).
With regards to Claim 6, the detected aglycones were naringenin and hesperetin (p.5, col.1, para.3). The type and amount of aglycones produced were dependent on the flavonoid glycosides before treatment. The aforementioned aglycones were produced from conversion of narirutin, naringin, and hesperidin (p.5, col.1, para.3; p.6, Table 1).
With regards to Claims 4 and 7, Lee discloses the content of furanocoumarins (bergapten or bergamottin) in the seven citrus peels and their alternations according to the treatment method. The steam treatment was shown to reduce the amount of furanocoumarin (bergapten or bergamottin) in the citrus peels (p.5, 3.2.3. Individual furanocoumarins; p.6, Table 1).
With regards to Claim 8, as shown in Lee’s Figure 2, the peels of yuzu, satsuma mandarin, grapefruit, and orange showed a higher total phenolic content when steamed for 2 hours compared to when it was not steamed (p.5, Fig.2).
With regards to Claim 10, Lee discloses that the antioxidant activities of the seven citrus peels increased with application of the steaming treatment (p.10, Figs. 6A and 6B; p.11, col.1, para.1-3).
With regards to Claim 11, Lee discloses that the flavonoid aglycones, such as quercetin and hesperetin, exhibited more potent inhibition of COX-1 and COX-2 compared to flavonoid glycosides, such as rutin and hesperidin, and in an anti-inflammatory activity test, aglycones were more effective than the flavonoid glycosides (p.5, col.1, para.2). As the high-temperature steaming process was shown to increase significantly increase the production of flavonoid aglycones in the peels (abstract), absent evidence to the contrary, the processed citrus peel extract has anti-inflammatory use.
With regards to Claims 19 and 22, Lee discloses that the increase in extraction efficiency up to 8 hours affected the increase in the aglycones, and the decrease in their content from excessive treatment was confirmed after 8 hours (p.5, col.1, para.3).
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, 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.
Claims 1, 3-17, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Lee) (LWT – Food Science and Technology; published Mar. 5, 2022) and Sente et al. (Sente) (US 2010/0040696 A1; published Feb. 18, 2010).
Note: Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
The teachings of Lee as they relate to Claims 1, 3-11, 13-15, and 19-22 are set forth above and incorporated herein. Additional relevant teachings of Lee are set forth herein below.
Lee discloses that various types of processed materials from citrus peels, e.g., phytochemicals such as phenolic acids, flavonoids, and essential oils, are currently used in tea, beverages, food, functional foods, cosmetics, and fragrances. Phenolic acids have gained attention because of their antioxidant effects, and flavonoids in citrus peels provide biological activities such as anti-inflammatory and antioxidant activities (p.1, 1. Introduction).
Lee does not appear to explicitly disclose applying the citrus peel extract of claim 13 or a composition comprising the citrus peel extract to a subject as recited in Claims 12, 16, and 17. Sente is relied upon for this disclosure. The teachings of Sente are set forth herein below.
Sente discloses topical compositions comprising composite particles with a unique antioxidant-based protective system for enhanced protection of the skin against oxidative stress caused by exposure to ultraviolet (UV) light or other environmental factors (para.0002). The composition is to be applied to the skin (para.0024).
Sente discloses that the skin is an organ where ROS is particularly liable to be formed, because it is directly exposed to various environmental assaults. Over the course of time under the cumulative influence of oxidative stress, the skin will start to show various signs of aging, such as thinning of the stratum corneum layer, loss of firmness and tonicity, excessive dryness, and appearance of fine lines and wrinkles (para.0004). Thus, Sente discloses a topical composition with strong antioxidant activities to scavenge excess ROS and to protect the skin against the harmful effects of oxidative stress (para.0005).
In order to protect the skin against the above described deleterious effects of the above-described oxidative damage to the skin, an antioxidant capable of preventing or reducing oxidative damage to the skin is provided. Among the suitable antioxidants capable of preventing or reducing oxidative damage to the skin include citrus peel extract (para.0023).
Sente discloses their particles being directly added to any pharmaceutically or cosmetically acceptable carrier to form a cosmetic or topical composition (para.0028). The pharmaceutically or cosmetically acceptable carriers are substances that are biologically compatible with human skin and can be used to formulate the active ingredients into a cream, gel, liquid, or lotion that can be topically applied (para.0028).
With regards to the active step recited in the instant Claims 12, 16, and 17 of applying the citrus peel extract or composition comprising the citrus peel extract to a subject, as discussed above, Sente discloses that citrus peel extract is known as an antioxidant capable preventing or reducing oxidative damage to skin. As Lee’s high-temperature steaming process was developed to improve chemical composition and efficacy of the citrus peels, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Lee with the teachings of Sente and topically apply Lee’s citrus peel extract or a composition comprising said citrus peel extract to a subject. One of ordinary skill in the art would have been motivated to do so in order to obtain the advantage of providing a citrus peel extract with improved chemical composition and improved efficacy, particularly in providing the benefits disclosed by Sente (e.g., preventing or reducing oxidative damage to skin. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Sente discloses that citrus peel extract is known to be topically applied to humans.
With regards to the preamble recited in Claims 12 and 17, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP 2111.02(II). In the present case, as the combined teachings of the cited prior art references is fairly suggestive of performing the claimed active step using the claimed product, absent evidence to the contrary, the prior art method as discussed above will also result in the intended purpose as recited in the preambles of claims 12 and 17.
Therefore, the claimed 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 instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 1, 3-11, 13-15, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Arifuku et al. (Arifuku) (JP 2021116288A; citations from EPO machine translation; of record).
Arifuku discloses a method for decomposing a glycoside and a method for producing aglycone (para.0001). Aglycones are known to have strong antioxidant properties, and are used in a variety of applications such as pharmaceuticals, health foods, and cosmetics (para.0002). The method produces aglycones in high yields with fewer impurities (para.0021).
With regards to Claims 1, 3, 9, 13-15, 20, and 21, Arifuku discloses a decomposition step of decomposing a glycoside into aglycone by hydrothermal treatment of a reaction solution containing a raw material containing a glycoside and water (para.0014).
The hydrothermal treatment may be carried out under the conditions of 110 to 300oC. When the temperature is within this range, the decomposition of glycosides can be further promoted (para.0019).
The hydrothermal treatment can be carried out by sealing the raw material together with water in a pressure-resistant sealed container (reading on airtight container), and heating it at a temperature exceeding 100oC while still sealed. The reaction liquid containing the raw materials and water is heated in the sealed container, whereby the inside of the sealed container becomes a heated and pressurized environment, and hydrothermal treatment is performed (reading on steaming) (para.0033).
Among the suitable raw material include fruits and dry powder obtained from citrus fruit peels. Among the suitable citrus fruits include satsuma mandarin (para.0032). Arifuku discloses that citrus peel is known to contain glycosides (para.0006).
The reaction temperature is preferably 120 to 190oC, and the reaction time is preferably 1 to 10 hours (para.0035). Arifuku exemplifies steaming citrus peel powder at 180oC for 1 hour (para.0044, Example 1).
The method also includes an extraction step of extracting aglycone from the decomposition product obtained in the decomposition step (para.0020).
Arifuku discloses drying the steamed solid (citrus peel powder) to obtain a powdered glycoside degradation product. The glycoside degradation product was adjusted to a 5% dispersion with ethanol (solvent) (para.0045) (the final product reading on a citrus peel extract).
Further regarding Claims 14 and 15, the claims recite an intended use of the citrus peel extract or the composition containing the citrus peel extract. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02. In the present case, there appears to be no structural difference between the claimed invention and the prior art, and the prior art disclosure does not include structures or otherwise that would preclude it from performing the claimed intended use. Thus, absent evidence to the contrary, the prior art structure is capable of performing the intended use, and therefore meets the claim.
With regards to Claims 4 and 5, the hydrothermal treatment of the raw material containing glycosides decomposes the glycoside into aglycone (para.0014-0015). The hydrothermal treatment may be carried out under the conditions of 110 to 300oC. When the temperature is within this range, the decomposition of glycosides can be further promoted (para.0019).
With regards to Claims 4-6, 8, 19, and 22, as discussed above, Arifuku discloses that the aforementioned hydrothermal treatment may be conducted on satsuma mandarin peels at a temperature and duration that overlaps with the instant claims. As evidenced by the instant application’s Example 2-2, performing such a method results in the limitations recited in the instant claims 4-6, 8, 19, and 22.
With regards to Claim 7, the claim depends from claim 4, which recites the conversion of flavonoid glycones to low-molecular flavonoid aglycones in the alternative with reducing the generation of furanocoumarin. Claim 7 does not positively recite that the steaming must result in a reduction of the generation of furanocoumarin. Thus, as currently written, claim 7 reads as the steaming is characterized by converting flavonoid glycones to low-molecular flavonoid aglycones or reducing the generation of furanocoumarin, and if there is a reduction in the generation of furanocoumarin, then the furanocoumarin is bergapten or bergamottin. In the present case, the Arifuku discloses a steaming step which converts flavonoid glycones to low-molecular flavonoid aglycones, and thus, reads on claim 7.
With regards to Claim 10, Arifuku discloses that their method as discussed above produced aglycones in high yields, and that aglycones are known to have strong antioxidant properties (para.0002, 0021).
With regards to Claim 11, as discussed above, Arifuku discloses that the aforementioned hydrothermal treatment may be conducted on satsuma mandarin peels at a temperature and duration that overlaps with the instant claims. As evidenced by the instant application’s Table 12, performing such a method on satsuma mandarin peel was shown to provide an extract with anti-inflammatory effects.
With regards to the temperature and duration of steaming, as discussed above, Arifuku discloses preferred temperature and duration ranges that overlap with the claimed ranges. Although Arifuku discloses ranges that encompasses temperatures and durations outside of the claimed ranges, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Therefore, the claimed 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 instant invention, because the teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 12, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Arifuku et al. (Arifuku) (JP 2021116288A; citations from EPO machine translation; of record) as application to Claims 1, 3-11, 13-15, and 19-22, further in view of Sente et al. (Sente) (US 2010/0040696 A1; published Feb. 18, 2010).
The teachings of Arifuku as they apply to Claims 1, 3-11, 13-15, and 19-22 are set forth above and incorporated herein.
Arifuku does not appear to explicitly disclose applying the citrus peel extract of claim 13 or a composition comprising the citrus peel extract to a subject as recited in Claims 12, 16, and 17. Sente is relied upon for this disclosure. The teachings of Sente are set forth above and incorporated herein.
With regards to the active step recited in the instant Claims 12, 16, and 17 of applying the citrus peel extract or composition comprising the citrus peel extract to a subject, as discussed above, Sente discloses that citrus peel extract is known as an antioxidant capable preventing or reducing oxidative damage to skin. As Arifuku’s method is intended to produce aglycones (compounds with strong antioxidant properties) in high yields with fewer impurities, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Arifuku with the teachings of Sente and topically apply Arifuku’s citrus peel extract or a composition comprising said citrus peel extract to a subject. One of ordinary skill in the art would have been motivated to do so in order to obtain the advantage of providing a citrus peel extract with fewer impurities when incorporating into a composition and topically applying to prevent or reduce oxidative damage to skin. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Sente discloses that citrus peel extract is known to be topically applied to humans, and Arifuku discloses that aglycones are known to be used in pharmaceuticals and cosmetics.
With regards to the preamble recited in Claims 12 and 17, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP 2111.02(II). In the present case, as the combined teachings of the cited prior art references is fairly suggestive of performing the claimed active step using the claimed product, absent evidence to the contrary, the prior art method as discussed above will also result in the intended purpose as recited in the preamble to claims 12 and 17.
Therefore, the claimed 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 instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Response to Arguments
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive.
(2) Applicant argues that in Arifuku, it is the raw material that is hydrothermally treated, and Arifuku merely discloses citrus peels in the context of a raw material powder. Thus, Applicant argues that Arifuku does not disclose steaming a citrus peel.
With regards to Applicant’s argument (2), the traversal argument is not found persuasive. Arifuku discloses performing the hydrothermal treatment (i.e., steaming in an airtight container) on the citrus fruit peel which is in powder form. The claims as currently written do not preclude the citrus fruit peel from being in the form of a powder.
Furthermore, Arifuku also discloses that the raw material undergoing the hydrothermal treatment may be the fruit, which encompasses the peel of the fruit. Although such an embodiment would include additional parts of the fruit aside from the peel, the claims as currently written do not require the peel to be removed from the fruit prior to steaming. Furthermore, the claims as currently written recite the open transitional phrase “comprising” and thus do not exclude unrecited elements.
(3) Applicant argues that the claimed method produces unexpected results. Applicant argues that the comparative evidence in the specification discloses the criticality of the claimed steaming conditions in terms of converting flavonoid glycones to aglycones, and the unexpected results of the resultant citrus peel extract in terms of therapeutic benefits.
With regards to Applicant’s argument (3), the traversal argument is not found persuasive. Applicant’s data in establishing the criticality of the claimed steaming conditions is not a comparison with that of the closest prior art, Arifuku. Arifuku fairly suggests steaming citrus fruit (e.g., satsuma mandarin) raw material, including the peel, at temperatures that overlap with that of the instantly claimed range, and for a duration that overlap with that of the claimed range. In particular, as discussed above, Arifuku discloses that the preferred reaction temperature is from 120-190oC, and that the more preferred reaction time is 1 to 10 hours. Arifuku also exemplifies the steaming conditions of 180oC at 1 hour.
Applicant’s Examples 2-2 to 2-8, looks at the effect of the duration of the steaming, testing durations of 30 min, 2hr, 4hr, 8hr, and 12hr, of the peels of the fruits claimed in claim 3. While it appears that in general, all seven of the citrus fruit peels tested showed that the flavonoid aglycones started to appear at 2hr of steaming, increasing up to the 8hr, then decreasing at 12hr, it that not be concluded from the data provided that the 2hr and 8hr are the critical end points. Arifuku discloses that the more preferred duration is from 1 to 10 hours. However, it is unclear from Examples 2-2 to 2-8 if the flavonoid aglycones started to appear at 2hr, or sometime between the 30 min. and 2hr (e.g., at 1hr). Furthermore, it is unclear if 8hr is the peak of aglycone content, or if the peak is found somewhere between the 8hr and 12hr mark (e.g., at 10hr).
Conclusion
Claims 1, 3-17, and 19-22 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MONICA A SHIN/Primary Examiner, Art Unit 1616