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, Remarks, and Request for Continued Examination filed on 01/20/26 are acknowledged.
Claims 5 and 7 were cancelled.
Claim 1 was amended.
Claims 1-4, 6, and 8 are pending.
Claim 8 was previously withdrawn from consideration.
Claims 1-4 and 6 are included in the prosecution.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/20/26 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/20/26 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 § 102(a)(1) - Mastaloudis
Applicant amended claim 1, part (ii), to recite “wherein the cherry blossom extract is an extract of cherry blossom petals, and wherein the cherry blossom extract contains caffeoyl glucose in an amount of 1 wt% or more and/or quercetin glycoside in an amount of 0.01 wt% or more.” Applicant’s arguments (Page 4, filed 01/20/26) with respect to the rejection of claims 1-4 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Mastaloudis et al. (US 2019/0255134 A1 – “Mastaloudis”) have been fully considered but are not persuasive. Applicant’s arguments are fully addressed following the maintained rejection below.
Rejection of claims under 35 USC §§ 102(a)(1) – JP-493 and 103 – JP-493/Shioda
In light of the amendment of claim 1 to recite “wherein the cherry blossom extract is an extract of cherry blossom petals, and wherein the cherry blossom extract contains caffeoyl glucose in an amount of 1 wt% or more and/or quercetin glycoside in an amount of 0.01 wt% or more,” (emphasis added) Applicant’s arguments (Pages 4-8, filed 01/20/26) with respect to the rejections listed below have been fully considered and are found persuasive.
Rejection of claims 1-3 and 6-7 under 35 U.S.C. 102(a)(1) as being anticipated by JP 2002-531493 A (English Google Translation – “JP-493”)
Rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over JP-493 in view of Shioda et al. (JP 2016-210706 A - English Google Translation – “Shioda”)
Since the cited prior art references, JP-493 and Shioda, do not expressly teach or suggest that the cherry blossom extract contains caffeoyl glucose in an amount of 1 wt% or more and/or quercetin glycoside in an amount of 0.01 wt% or more, the rejections listed above are withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of new supporting reference Tsutsumi et al. (JP WO 2015 125822 A1 – English Espacenet Translation).
Maintained Rejections
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 1-4 and 6 are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mastaloudis et al. (US 2019/0255134 A1 – “Mastaloudis”).
Instant claim 1 is drawn to a composition for ameliorating an unpleasant state caused by menstruation by suppressing epithelial-mesenchymal transition (EMT) of endometrial epithelial cells or by normalizing a stage of endometrial epithelial cells, the composition comprising black rice extract and/or cherry blossom extract, wherein
(i) when the composition contains the black rice extract, a content of polyphenols in the black rice extract is 15 wt% or more, and
(ii) when the composition contains the cherry blossom extract, the cherry blossom extract is an aqueous-ethanol extract, wherein the cherry blossom extract is an extract of cherry blossom petals, and wherein the cherry blossom extract contains caffeoyl glucose in an amount of 1 wt% or more and/or quercetin glycoside in an amount of 0.01 wt% or more.
Mastaloudis teaches a composition including a combination of cyanidins and delphinidins (Abstract) which can be derived from a black rice component ([0087]-[0090], [0103], [0159]-[0170], [0319], [0339], [0352], [0368], claims 1, 4-15, 49-51, 72, and 77-79). Tables 1, 3, and 4 show an exemplary formulations containing black rice extracts ([0111]). Mastaloudis also teaches a composition in the form of an oral dosage formulation which is a capsule, a tablet, a powder, a beverage, a syrup, a gummy, a wafer, a confectionery, a suspension, or a food ([0114], [0228], claims 1, and 72-74). The Human Study describes administration of the composition containing black rice extract ([0368]) to participants including females, who experienced a reduction in bloating due to menstrual cycle (Table 20), a reduction in abdominal pain due to menstrual cycle ([0381] – Table 21), and a reduction in gas due to menstrual cycle (Table 22). The black rice component can be derived from black rice kernels and is a black rice extract ([0088]-[0089]). Table 1 discloses an exemplary formulation comprising black rice extract with 25% AC ([0111] and claim 14), wherein AC stands for anthocyanins ([0079]), which are polyphenols.
Regarding instant claim 1, the limitation of a composition for ameliorating an unpleasant state caused by menstruation, the composition comprising at least one component selected from the group consisting of black rice, cherry blossom and extracts thereof is anticipated by the exemplary formulations containing black rice extracts with 25% AC or anthocyanins or polyphenols ([0111] and claim 14), and the composition in the form of an oral dosage formulation which is a capsule, a tablet, a powder, a beverage, a syrup, a gummy, a wafer, a confectionery, a suspension, or a food ([0114], [0228], claims 1, and 72-74), which is further used to treat female human subjects who experienced bloating, abdominal pain, and gas due to menstrual cycle ([0368], Tables 20-22), as taught by Mastaloudis.
Regarding instant claim 1, the newly added limitation of suppressing epithelial-mesenchymal transition (EMT) of endometrial epithelial cells or by normalizing a stage of endometrial epithelial cells is an inherent property of the composition and inseparable from it. According to MPEP 2112.01(I), “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.)”.
Furthermore, although Mastaloudis teaches the treatment of bloating, abdominal pain, and gas, the claimed recitation of “ameliorating an unpleasant state caused by menstruation” is a future intended use and is not given patentable weight. Instant claim 1 is drawn to a composition and not a method of ameliorating an unpleasant state caused by menstruation.
Regarding instant claim 1, the limitations of the black rice extract and a content of polyphenols in the black rice extract of 15 wt% or more is anticipated by the black rice extract with 25% AC ([0111] and claim 14), wherein AC stands for anthocyanins ([0079]), which are polyphenols, as taught by Mastaloudis.
Regarding instant claims 2-3, the limitations of the unpleasant state are anticipated by the treatment of bloating, abdominal pain, and gas due to menstrual cycle ([0368] and Tables 20-22), as taught by Mastaloudis.
Regarding instant claim 4, the limitation of the black rice extract which contains at least one component selected from the group consisting of a hull, an aleurone layer, a pericarp, a germ and an endosperm of black rice is anticipated by the black rice component derived from black rice kernels ([0088]), as taught by Mastaloudis.
Regarding instant claim 6, the limitation of the oral preparation is anticipated by the oral dosage formulation which is a capsule, a tablet, a powder, a beverage, a syrup, a gummy, a wafer, a confectionery, a suspension, or a food ([0114], [0228], claims 1, and 72-74), as taught by Mastaloudis.
Response to Arguments
Applicant’s arguments (Page 4, filed 01/20/26) with respect to the rejection of claims 1-4 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Mastaloudis have been fully considered but are not persuasive.
Applicant argues that claim 1 has been amended to incorporate the features of claim 5, now canceled, which was not the subject of this rejection.
Applicant’s argument is acknowledged. However, even though claim 1 has been amended to incorporate the features of claim 5, now canceled, which was not the subject of the anticipation rejection based on Mastaloudis, claim 1 still recites an option or choice for the composition to contain the black rice extract in part (i) or the cherry blossom extract in part (ii). Claim 1 recites: “… (i) when the composition contains the black rice extract, a content of polyphenols in the black rice extract is 15 wt% or more, and (ii) when the composition contains the cherry blossom extract, the cherry blossom extract is …” (emphasis added).
Therefore, the limitation of claim 1, “… when the composition contains the black rice extract …” is anticipated by the exemplary formulations containing black rice extracts with 25% AC or anthocyanins or polyphenols ([0111] and claim 14), and the composition in the form of an oral dosage formulation which is a capsule, a tablet, a powder, a beverage, a syrup, a gummy, a wafer, a confectionery, a suspension, or a food ([0114], [0228], claims 1, and 72-74), which is further used to treat female human subjects who experienced bloating, abdominal pain, and gas due to menstrual cycle ([0368], Tables 20-22), as taught by Mastaloudis.
The newly added limitation in instant claim 1 regarding part (ii) and the cherry blossom extract, that was imported from claim 5, is an option or choice that is not positively required for the claimed composition. Instant claim 1 and part (i) is anticipated by Mastaloudis, as explained above.
Therefore, the rejection of 10/17/25 is maintained.
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 1-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2002-531493 A (English Google Translation – “JP-493”) in view of Shioda et al. (JP 2016-210706 A - English Google Translation – “Shioda”) and Tsutsumi et al. (JP WO 2015 125822 A1 – English Espacenet Translation – “Tsutsumi”).
Instant claim 1 is drawn to a composition for ameliorating an unpleasant state caused by menstruation by suppressing epithelial-mesenchymal transition (EMT) of endometrial epithelial cells or by normalizing a stage of endometrial epithelial cells, the composition comprising black rice extract and/or cherry blossom extract, wherein
(i) when the composition contains the black rice extract, a content of polyphenols in the black rice extract is 15 wt% or more, and
(ii) when the composition contains the cherry blossom extract, the cherry blossom extract is an aqueous-ethanol extract, wherein the cherry blossom extract is an extract of cherry blossom petals, and wherein the cherry blossom extract contains caffeoyl glucose in an amount of 1 wt% or more and/or quercetin glycoside in an amount of 0.01 wt% or more.
JP-493 teaches the use of at least one compound obtained from cherries for inhibiting the cyclooxygenase or prostaglandin H synthase enzyme (Abstract and claims 1-20). The compound is from cherry blossom (claims 6 and 15). A nutritional composition comprising an extract of cherries provides pain relief when ingested, wherein the pain may be menstrual pain (Page 3 of 12). The composition is in an oral dosage form such as a capsule, tablet, syrup, beverage, powder, and the like (Page 2 of 12 - [0009], Page 3 of 12, Page 4 of 12, Page 5 of 12 – Example 1 Results). Cherry extracts are disclosed ([0009]-[0010]), wherein the solvent used to remove anthocyanins includes ethanol azeotroped (or mixed) with water ([0016]). The flavonoids that are extracted from cherry include quercetin (Example 5).
JP-493 does not expressly teach a cherry blossom extract that contains caffeoyl glucose in an amount of 1 wt% or more and/or quercetin glycoside in an amount of 0.01 wt% or more.
Shioda teaches an antioxidant/anti-inflammatory agent containing an extract of cherry blossom or its extract residue as an active ingredient, wherein cherry petals are used (Abstract, claims, Page 3 of 10, Examples 1-3 – Page 6 of 10). Shioda discloses a dosage form including oral solid preparations (tablets, coated tablets, granules, powders, capsules, etc.), and oral liquid preparations (liquids, syrups, elixirs, etc.) (Page 5 of 10).
Tsutsumi teaches an oral composition comprising cherry blossom extract which contains caffeoyl glucose (Abstract, [0001], claims 1-7). The cherry blossom extract preferably contains caffeoyl glucose at a concentration of 2% or more ([0017]). The solvents used in the extraction include water, ethanol, and combinations ([0015]). Oral dosage forms include toothpastes, dentifrices, gels, ointments, gargling tablets, oral pastes, and gum massage creams ([0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an extract of cherry blossom, as taught by JP-493, in view of the extract of cherry blossom petals, as taught by Shioda, and the oral composition comprising cherry blossom extract which contains caffeoyl glucose at a concentration of 2% or more, as taught by Tsutsumi, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all three references teach extracts of cherry blossoms for incorporation into oral dosage forms such as tablets and both JP-493 and Shioda teach the use of such dosage forms for treating inflammation and pain. JP-493 teaches inhibition of inflammation (Abstract, claim 7) and Shioda teaches that the extract of cherry blossoms is an anti-inflammatory agent (Abstract, claims 1-5). Moreover, it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have had a reasonable expectation of success in using the petals of cherry blossom, as taught by Shioda, in order to prepare an extract, wherein the cherry blossom extract contains 2% or more of caffeoyl glucose, as taught by Tsutsumi, and incorporate it into oral dosage forms for the treatment of inflammation, which are taught by JP-493.
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 composition for ameliorating an unpleasant state caused by menstruation, the composition comprising at least one component selected from the group consisting of black rice, cherry blossom and extracts thereof would have been obvious over the use of at least one compound obtained from cherries for inhibiting the cyclooxygenase or prostaglandin H synthase enzyme (Abstract and claims 1-20), wherein the compound is from cherry blossom (claims 6 and 15), and a nutritional composition comprising an extract of cherries provides pain relief when ingested, wherein the pain may be menstrual pain (Page 3 of 12), as taught by JP-493.
Regarding instant claim 1, the newly added limitation of suppressing epithelial-mesenchymal transition (EMT) of endometrial epithelial cells or by normalizing a stage of endometrial epithelial cells would have been obvious over the nutritional composition comprising an extract of cherries provides pain relief when ingested, wherein the pain may be menstrual pain (Page 3 of 12), as taught by JP-493.
Regarding instant claim 1, the newly added limitation of the cherry blossom extract that is an aqueous-ethanol extract would have been obvious over the cherry extracts ([0009]-[0010]), wherein the solvent used to remove anthocyanins includes ethanol azeotroped (or mixed) with water ([0016]), as taught by JP-493, and by the extraction solvents including water and ethanol ([0015]), as taught by Tsutsumi.
Regarding instant claim 1, the limitation of an extract of cherry blossom petals would have been obvious over the extract of cherry blossom wherein cherry petals are used (Abstract, claims, Page 3 of 10, Examples 1-3 – Page 6 of 10), as taught by Shioda.
Regarding instant claim 1, the limitation of the cherry blossom extract containing caffeoyl glucose in an amount of 1 wt% or more would have been obvious over the cherry blossom extract which preferably contains caffeoyl glucose at a concentration of 2% or more ([0017]), as taught by Tsutsumi.
Regarding instant claims 2-3, the limitations of the unpleasant states would have been obvious over the menstrual pain relief (Page 3 of 12), as taught by JP-493.
Regarding instant claim 6, the limitation of the oral preparation would have been obvious over the capsule, tablet, syrup, beverage, powder, and the like (Page 2 of 12 - [0009], Page 3 of 12, Page 4 of 12, Page 5 of 12 – Example 1 Results), as taught by JP-493, and by the oral dosage forms including toothpastes, dentifrices, gels, ointments, gargling tablets, oral pastes, and gum massage creams ([0021]), as taught by Tsutsumi.
Conclusion
13. No claims are allowed.
14. 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