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 amendment filed July 13th, 2026.
Claim 11 was canceled by the applicant.
Claims 1-6, 8-10, 12, and 13 are pending and was examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a
prior Office action.
Any objections or rejections not reiterated below are hereby withdrawn.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The foreign priority date is November 27th, 2023.
The provisional application 63/386,175, does not disclose a method for reducing skin redness comprising administering to a subject in need thereof a composition comprising an effective dose of kiwiberry extract, as instantly claimed in in independent claim 1, from which all other claims depend. The provisional does not disclose measuring skin redness using polarized light as instantly claimed in independent claim 1, from which all other instant claims depend. Therefore, the priority date of this application is November 27th, 2023.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed July 13th, 2026, with respect to the rejection of claim 1 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 1 under 35 U.S.C. 112(b) has been withdrawn. The applicant has amended claim 1 to replace the term “soothing” with the term “reducing” and to define skin redness as follows “wherein the skin redness is measured by detecting deep blood vessels or hemoglobin in the skin under RBX polarized light”.
Applicant’s arguments, filed July 13th, 2026, with respect to the rejection of claims 1-6, 8-10, 12, and 13 under 35 U.S.C. 103 have been fully considered and are persuasive for the reasons discussed below. The rejection of claims 1-6, 8-10, 12, and 13 under 35 U.S.C. 103, on the grounds recited in the previous office action, has been withdrawn. The applicant has amended independent claim 1, from which claims 2-6, 8-10, 12, and 13 depend, to recite “wherein the skin redness is measured by detecting deep blood vessels or hemoglobin in the skin under RBX polarized light”. Amended claim 1 implies that the skin redness, as claimed, is caused by deep blood vessels or hemoglobin in the skin. Therefore, reducing “skin redness” as currently claimed would require treatment that reduces the size of blood vessels in the skin, not merely reducing the appearance of blood vessels to the naked eye. In contrast, the appearance of redness to the naked eye is reasonably a function of multiple factors including blood vessel size, the health of the skin extracellular matrix, and non-vascular skin tissue. The cited prior art references, Kim, Silva, and Tabe, do not explicitly recite an Actinidia fruit, or an extract thereof, reducing the size of blood vessels in the skin. Therefore, the subject matter recited in instant independent claim 1 is no longer obvious over the cited prior art references.
The rejection of claim 11 under 35 U.S.C. 103 has been withdrawn, this claim having been cancelled by the applicant
Pending Objections and Rejections
Specification
The use of the terms RBX and Sigma (registered as Sigma-Aldrich and Millipore Sigma), each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks,
certification marks, and collective marks) are permissible in patent applications, the proprietary nature
of the marks should be respected and every effort made to prevent their use in any manner which might
adversely affect their validity as commercial marks.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this
patent or patent application publication with color drawing(s) will be provided by the Office upon
request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). The examiner is prosecuting the application and the status of the petition has not been made of record prior to mailing of this office action. The color drawing petition has not been approved, but appears pending before the office prior to the mailing of this action.
Claim Rejections - 35 USC § 112
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.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps of administering an effective dose of kiwiberry extract, and the steps of measuring "Brix degree". Regarding the term "Brix degree": prior art disagrees regarding whether the term "Brix degree" refers to sucrose content (US 20120263704 A1, paragraph [0032]) or more broadly to the content of solid state substances dissolved in a liquid (US 20220177396 A1, paragraph [0061]). Therefore, one of skill in the art would not be reasonably appraised to understand the limits of the meaning of the term "Brix degree" as currently recited in instant claim 1. Therefore, the limitations of claim 1 regarding a Brix degree are rendered indefinite. The applicant is notified that the specification lacks adequate support to amend claim 1 to overcome this indefiniteness while retaining limitations regarding a Brix degree.
Claim 1 is 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. Regarding the phrase "a subject in need thereof", it is not clear what threshold of skin redness in a subject would be sufficient to warrant administering the composition as claimed.
Claim 1 contains the trademark/trade name RBX. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a type of polarized light and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP-4620461-B2.
JP-4620461-B2 recites an Actnidia arguta fruit extract, teaching that it would be administered to a mammal:
“[Claim 1] A composition for the prevention or treatment of allergic diseases in mammals, comprising an extract of Actinidia arguta, Actinidia kolomikta, or Actinidia polygama as an active ingredient.
[Claim 2] The composition according to claim 1, prepared from one or more parts selected from the group consisting of fruits, stems, and roots of Actinidia arguta, Actinidia kolomikta, or Actinidia polygama.
[Claim 3] The composition according to claim 1 or 2, wherein the extract is a crude extract soluble in a polar solvent, or an extract soluble in a non-polar solvent.
[Claim 4] The composition according to claim 3, wherein the polar solvent is distilled water or 70% ethanol
…
[Claim 6] The composition according to claim 1 or 2, wherein the extract is obtained by a procedure comprising the following steps: a) Mix pulverized and dried Actinidia arguta, Actinidia kolomikta, or Actinidia polygam[a] a with water or a lower alcohol; b) Heat the mixture with water or a lower alcohol; c) Obtain an extract after step (b).
…
[Claim 9] The composition according to any one of claims 6 to 8, wherein in step (b), heating is carried out between approximately 20°C and 100°C for approximately 1 to approximately 24 hours.
…
[Claim 14] A composition according to any one of claims 1 to 13, comprising the extract in any of the following amounts: (i) an amount sufficient to reduce the serum IgE concentration of a mammal compared to before administration of the composition; (ii) a[n] amount that reduces the production of Th2 cytokines by mammalian cells compared to before administration of the composition. …” (instant independent claim 1, and dependent claims 2-6 and 8).
Furthermore, JP-4620461-B2 teaches overlapping ratios of kiwi material to water, during extraction, with those recited in instant claims 9 and 12, and a preference for a narrower extraction temperature range than that cited above, still encompassing 70 °C to 90 °C: “The crude extract of cold-hardy kiwi of the present invention can be prepared as follows: Dry the cold-hardy kiwi and grind it; mix the ground cold-hardy kiwi with 5 to 25 times, preferably about 10 times, volume of distilled water, methanol, ethanol, butanol, or a lower alcohol, or a mixture thereof, preferably water or 70% ethanol; treat the solution with hot water at a temperature in the range of 20 to 100°C, preferably 60 to 100°C, …” (paragraph [0040]; instant claims 1, 9, and 12). Regarding the cold-hardy kiwi species and organ, JP-4620461-B2 teaches Actinidia arguta fruit (paragraph [0032]; instant claims 1, 9, and 12). Although the machine translation recites “Actinidia alguta”, this text is interpreted as containing a typographical error deviating from correct spelling, Actinidia arguta (JP-4620461-B2, paragraph [0032]).
The condition of skin redness reasonably overlaps with allergic diseases in mammals as taught by JP-4620461-B2, as certain allergic reactions are broadly known to encompass skin redness in the form of a rash or hives. Furthermore, administering an Actinidia arguta fruit extract as recited in the instant claims, with the effects recited in the instant claims, is anticipated even if these effects are not explicitly recited by the reference, because the administration taught by the reference would inherently have the same effect as administering the Actinidia arguta extract as instantly claimed. These effects encompass, but are not limited to reducing redness as measured using polarized light (recited as “RBX® polarized light”, instant claim 1). ("[T]he examiner further finds that the effects of the treatment recited in appellant's claims would be 'inherent' to the 'administration of the same compound to the same patient population for the treatment of the same disease' ... after fully considering the record, we agree with, and adopt examiner's findings and reasoning in support of the obviousness rejection ... we, therefore, affirm." See Appeal 2021-003546 (15/514,651)). See also MPEP § 2112.01(II) ("A chemical composition and its properties are inseparable … if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present").
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.
Claims 1-6, 8-10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over JP-4620461-B2; and further in view of RU-2009116642-A.
The prior art reference JP-4620461-B2 is made of record above.
Claim 10 recites “The method according to claim 8, wherein when the composition is in liquid form, the effective dose of the composition is 2 g/day, or when the composition is in solid form, the effective dose of the composition is 0.2 g/day”. Claim 13 recites “The method according to claim 1,wherein when the composition is in liquid form, the effective dose of the composition is 2 g/day, or when the composition is in solid form, the effective dose of the composition is 0.2 g/day.”.
The instant claims are distinguished from JP-4620461-B2 in that this reference does not explicitly recite the effective doses recited in instant claims 10 and 13 above. However, these doses are obvious to one of skill in the art over the course of routine optimization. One of skill in the art could optimize doses by varying the amount of the compositions administered to patients or cell cultures and observing biological effects of these administered amounts, without changing the presence of any active ingredients in the compositions. One of skill in the art would have reasonable expectation of success at administering such doses by calculating the densities of the compositions from mass and volume measurements, and administering the volumes corresponding to the masses claimed for liquid and solid compositions, respectively. The biological effects of different doses could be compared by measuring the skin redness of subjects administered the extract, where the skin redness is measured by capturing a digital image of the skin in mutually orthogonal polarized light, storing the image, converting the image into color space data, and quantitatively analyzing the color space data (RU-2009116642-A, Abstract and claims 1 and 7; instant claims 10 and 13).
JP-4620461-B2 and RU-2009116642-A are relied upon for the reasons discussed above. If not
expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the method comprising administering a composition comprising kiwiberry extract, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the method comprising administering a kiwiberry extract composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of JP-4620461-B2 in view of RU-2009116642-A, the invention as a whole, drawn to a method comprising administering a composition comprising kiwiberry extract as described in Claim 1-6, 8-10, 12, and 13, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
Ge et al. (CN-102948853-A) recites “kiwi fruit contains a relatively high 5-hydroxytryptamine (vasoconstricting)” (paragraph [0002]), implying that kiwi fruit contains the compound 5-hydroxytryptamine, which has a vasoconstricting effect. Ge et al. refers to kiwi fruit as gooseberry (paragraph [0002]) and recites the following aqueous extraction of kiwi fruit/”gooseberry: “(I) respectively preparing kiwi fruit, emblic leafflower fruit juice liquid;
the step of extracting the step of extracting (0032) Chinese goosebeery juice liquid is as follows: selecting 8 parts of kiwi fruit fresh rehmannia 1 kg, peel after cleaning the vegetables, placing in disinfection liquid soaking and sterilizing and then taking out, using sterile water to wash for three times, then according to the Chinese goosebeery pure water is equal to 1: 2 proportion of coarse filter in the processor, for I hours, then centrifuging for 4000r/min at 20 to 40 min, preferably 40 min, centrifugally separating the supernatant to obtain the fresh Chinese goosebeery” (paragraphs [0031] and [0032]).
Sawamura et al. The Journal of Physical Chemistry B 2001, 105 (12), 2429-2436.
Sawamura et al. discloses an increase in the water solubility of certain hydrophobic compounds,
alkylbenzenes (toluene, ethylbenzene, and propylbenzene), in water as temperature increases
from 298.2 K to 323.2 K (Table 1).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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