DETAILED NOTICE
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 .
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, filed on February 4, 2025.The priority date is August 27, 2021.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 02/27/2024,10/10/2024, 06/02/2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings were received on 02/27/2024. These drawings are accepted.
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.
Claims 2-8 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.
In claims 2-8, it is unclear what is meant by the phrases, “characterized in that” and “characterized by”. Does the composition have the feature or what characteristic is being limited in the claim? Suggest removing the phrases and reciting in the affirmative that the composition comprises the features claimed.
In claim 5, it is unclear what “a property stability” is limited to. The scope of property stability is unclear. Suggest identifying the property that is stabilized for the composition.
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.
Claims 1-3 and 5-8 are rejected under 35 U.S.C 102 (A)(1) as being anticipated by Kim et al. (Appl. Sci. 13(21): 11681, (2023)).
The claims are as of record, drawn to a cosmetic composition comprising iris rhizome-derived exosomes characterized for moisturizing skin, improving skin wrinkles and whitening skin. The claims are drawn to purifying the iris rhizome-derived exosomes.
The reference (Kim 13(21) 2023, see entire document) anticipates the claims by teaching a method of purifying the Iris germanica L. rhizomes, the extracts were centrifugated at 10,000 x g and then freeze dried. A supernatant was mixed with distilled water and an aqueous two-phase system. The system was prepared by adding Polyethylene Glycol (PEG) and Dextran. After mixing the supernatant PEG/Dextran solution the exosomes were recovered and washed with an aqueous two-phase system (see page 3 of 18, section 2. Materials and Methods). The ultra-high-pressure treatment performed on the iris rhizomes was performed at 25 C at a pressure of 200 Mpa. To prevent destabilization of the exosomes the reference further teaches the exosomes were washed with an additional aqueous two-phase system at the same concentration as the first system, containing polyethylene glycol and dextran (see page 3 of 18, section 2. Materials and Methods). The reference teaches that the exosome treatment contributes to skin aging, regeneration, skin barrier and moisturization (see entire document, and e.g. 2nd sentence of Abstract).
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. The intended uses of the iris rhizome-derived exosomes will necessarily result from the composition as currently claimed.
Please note, since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. 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).
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.
Claims 1-8 are rejected under 35 U.S.C 103 as being unpatentable over Kim et al. (Appl. Sci. 13(21): 11681, (2023)) in view of Seung (KR102490802B1).
Kim et al. teaches a method of purifying the Iris germanica L. rhizomes, the extracts were centrifugated at 10,000 x g and then freeze dried. A supernatant was mixed with distilled water and an aqueous two-phase system. The system was prepared by adding Polyethylene Glycol (PEG) and Dextran. After mixing the supernatant PEG/Dextran solution the exosomes were recovered and washed with an aqueous two-phase system (see page 3 of 18, section 2. Materials and Methods). The ultra-high-pressure treatment performed on the iris rhizomes was performed at 25 C at a pressure of 200 Mpa. To prevent destabilization of the exosomes the reference further teaches the exosomes were washed with an additional aqueous two-phase system at the same concentration as the first system, containing polyethylene glycol and dextran (see page 3 of 18, section 2. Materials and Methods).The reference teaches that the exosome treatment contributes to skin aging, regeneration, skin barrier and moisturization (see entire document, and e.g. 2nd sentence of Abstract). As discussed above in Kim, the references teach a method of purifying iris rhizomes-derived exosomes to provide a treatment that contributes to skin aging, regeneration, skin barrier and moisturization (see entire document, and e.g. 2nd sentence of Abstract), however Kim does not disclose skin whitening.
Sueng 802’ teaches a method where the iris derived exosome treatment group is diluted in a serum free medium concentration, and centrifuged. In this present invention the term iris-derived exosome refers to a plant of the genus iris, including Iris germanica which is an iris-rhizome derived exosome. As a result of the purification of the iris derived exosome, it was found that as a cosmetic an individual would see results pertaining skin elasticity, wrinkle improvement, regeneration and skin whitening (see Technical field, paragraph 2 and claim 1).
Although Sueng does not disclose the methods of purifying iris-derived exosomes using centrifuging and the steps of purification as claimed, it would have been obvious to the person having ordinary skill in the art to combine extraction and purification methods disclosed by Kim et al, to isolate iris-derived exosomes to use them as a cosmetic composition to improve skin, moisturizing skin, and skin whitening, since Sueng 802’ teaches using iris-derived exosomes for a cosmetic that can improve skin elasticity, skin wrinkles, and skin whitening. It would have been obvious to the person having ordinary skill in the art to use iris-derived exosomes for skin moisturizing, skin wrinkles, and skin whitening because Sueng 802’ teaches that use. .
Therefore, it would have been obvious to the person having ordinary skill in the art to purify the iris-derived exosomes as disclosed by Kim et al. and use them as a cosmetic composition to improve skin, moisturizing skin, and skin whitening as disclosed by Sueng et al., because Kim et al. and Sueng et al. both disclose using the iris-rhizomes derived-exosomes for skin care.
Conclusion
No claims allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARNITIA T WALKER whose telephone number is (571)272-2550. The examiner can normally be reached Monday-Friday 8:00am-5:00pm.
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/Marnitia T Walker/
Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655