-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 .
Applicant's response dated June 18, 2026 is acknowledged.
Priority
This application is a CON of PCT/KR2023/000834 filed on 01/18/2023, and claims
foreign priority in Korean application KRl0-2022-0010217 filed on 01/24/2022, and KRl0-
2023-0006863 filed on 01/17/2023.
Claim Status
Claims 1-17 are pending. Claims 1, 2, 5, and 7 were amended. Claims 10-17 are withdrawn. Claims 1-9 are examined.
Withdrawn Claim Rejections - 35 USC § 112
Rejections of claims 2, 7, and 8 are withdrawn because rejections were obviated with claim amendments.
Withdrawn Claim Rejections - 35 USC§ 103
Obviousness rejections of claims 7 and 8 are withdrawn because claim 7 was amended to require step (a2) or step (a3), and neither of the two steps is obvious.
Maintained Claim Rejections - 35 USC§ 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C.
102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a
new ground of rejection if the prior art relied upon, and the rationale supporting the rejection,
would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Behr (US
2007/0122492 Al Published May 31, 2007 - of record in IDS dated 06/10/2024).
The claims are drawn to a method for skin regeneration comprising topically
administering a composition to a skin of a subject in need thereof, wherein the composition
comprises isolated exosomes derived from Nepeta cataria as an active ingredient.
The teachings of Behr are related to compositions comprising one or more plant extracts
that are capable of inhibiting one or more of MMP-1, MMP-2, MMP-3, MMP-9, and HLE. The
compositions are used in a method for treating or preventing dermatological conditions including
wrinkling or sagging of the skin, irradiation induced skin damage, deepening of skin lines, and
elastotic changes in the skin (Abstract). In one embodiment, the composition is used in a method
of improving the health of skin (paragraphs 0020 and 0024), or a in a method of attenuating or
preventing skin ageing (paragraphs 0021, 0022, 0025, and 0026). The plant extract is derived
from one of the plants listed in Tables 1-5 (paragraph 0064). The plant extracts are solvent-based
extracts obtained from the selected plant by solvent extraction. The solvent can be an aqueous
solvent such as water or a buff er, or it can be a liquid organic compound, or a combination of an
aqueous solvent and a liquid organic compound. In one embodiment, the plant extract is an
aqueous, alcoholic or aqueous alcoholic extract (paragraph 0068). A number of standard
extraction techniques known in the art can be employed to prepare the plant extracts. In general,
the extraction process entails contacting solid plant material with a solvent with adequate mixing
and for a period of time sufficient to ensure adequate exposure of the solid plant material to the
solvent such that inhibitory activity present in the plant material can be taken up by the solvent
(paragraph 0075). The plant material employed in the extraction process can be the entire plant,
or it can be one or more distinct tissues from a plant, for example, leaves, flowers, roots, seeds,
pods, stems, fruits, seed coats, buds, or various combinations thereof (paragraph 0076). The plant
material may be treated prior to extraction process in order to facilitate the extraction process.
For example, the plant material can be crushed or sliced mechanically, using a grinder or other
device to fragment the plant parts into small pieces or particles, or the plant material can be
frozen in liquid nitrogen and then crushed or fragmented into smaller pieces (paragraph 0079).
Paragraphs 0080-0084 describe the extraction process in detail. The compositions are for topical
administration, and may be in the form of aerosol sprays, powders, sticks, granules, creams,
liquid creams, pastes, gels, lotions, syrups, ointments, on sponges or cotton applicators, or as a
solution or a suspension in an aqueous liquid, a non-aqueous liquid, an oil-in-water emulsion, or
a water-in-oil liquid emulsion (paragraph 0159). Examples of dermatological conditions
contemplated in the method of treatment, include dry skin; dandruff; acne; keratosis; psoriasis;
eczema; pruritus; age spots; reduced skin moisture; spider veins; senile purpura; lentigines;
melasmas; deepening of skin lines; blotches; wrinkles; blemished skin; nodules; atrophy;
rosacea; impetigo; elastotic changes characterized by leathery, course, rough, dry and yellowish
skin; telangiecatic skin; hyperpigmented skin; hyperkeratotic skin; inflammatory dermatoses
(paragraph 0182). The compositions can also be used to promote wound healing and/or decrease
the risk of scarring (paragraph 0183). In one embodiment, an effective amount of the plant
extract is administered to mammal in order to attenuate one or more undesirable structural
changes in the skin, such as wrinkling and/or sagging of the skin, loss of skin elasticity, redness,
inflammation, formation of lesions, thinning of the epithelium, abnormal migration of cells
within the skin (such as that which occurs during angiogenesis or inflammation), or various
combinations thereof (paragraph 0184). By "effective amount" it is meant an amount of the
plant extract or active ingredient that provides a beneficial effect in the treatment of a
dermatological condition or a desired skin improvement effect. It should be understood by one of
ordinary skill in the art that this amount will vary depending on the application and on the
individual subject and will be readily determinable by one of skill in the art (paragraph 0186).
Tables 1-5 teach extracts of Nepeta cataria and their inhibition effects on MMP-1, MMP-2, MMP-3, and MMP-9 (paragraphs 0244-0247).
Regarding claims 1 and 5, it would have been prima facie obvious to a person of ordinary
skill in the art before the effective filing date of the claimed invention to have treated a wound by
topically applying a composition comprising an effective amount of an extract obtained from
N epeta cat aria, with a reasonable expectation of success because Behr teaches extracts from
plants such as Nepeta cataria are capable of inhibiting one or more of MMP-1, MMP-2, MMP-3,
and MMP-9, and where the extracts are suitable for use in a method of treating a wound by
topically applying the composition comprising a therapeutically effective amount of the extract.
It would have been obvious to have obtained the extract from the plant parts by reducing the plant parts in size such as by cutting, and extracting the plant parts with water or a buff er, with a reasonable expectation of success because Behr teaches said method is suitable for obtaining the plant extract. As evidenced by bottom of page 11 in the instant specification, juice extracted from Nepeta cataria contains exosomes. Behr's method is also a method of extracting juice from Nepeta cataria and Behr's extract contains exosomes, as evidenced by instant specification. Exosomes in the extract obtained by Behr’s method meet the limitation that requires isolated exosomes because the extract and the exosomes contained therein were isolated from the plant or plant parts. A subject in need of a wound treatment is a subject in need of skin regeneration. Therefore, Behr's method of treating a wound in a subject in need thereof is a method of skin regeneration in a subject in need of skin regeneration.
Regarding claims 2, 3, and 6, it would have been obvious to have formulated the
composition as a cream because Behr teaches cream as a suitable composition form.
Regarding claims 4 and 9, it would have been obvious to have treating the skin of a
human with a reasonable expectation of success because Behr teaches testing the plant extract on
human volunteers (paragraph 0098) and on human skin model (paragraph 0267).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Behr as applied to claims 1-6 and 9 above, and further in view of Smith (WO 94/13257 Published June 23, 1994) and Parrinello (US 2008/0199489 A1 Published August 21, 2008).
The teachings of Behr are relied upon as summarized above. Behr does not teach the limitations of claims 7 and 8.
The teachings of Smith are related to a lotion for treatment of pathologies of the skin. The lotion comprises a therapeutic agent. The emollient system of the lotion provides a moisturizing and soothing effect on the skin, and the occlusive nature of the lotion causes hydration of the skin to facilitate the enhance penetration of the therapeutic into the skin (Abstract). The lotion may be applied to the skin by hand or by means of an absorbent fibrous or cellular sheet
material that is impregnated with the composition. When the impregnated sheet is pressed or rubbed against a skin surface, an effective amount of the composition is released and coated onto the skin without skipping or separating on the skin (page 2 lines 25-31). The lotion may be incorporated into an absorbent sheet, such as a fibrous or cellular flexible material that can retain sufficient amounts of the lotion to effectively apply the lotion to the surface of the skin without bleeding during storage of the sheet or administration of the lotion to the skin (paragraph bridging pages 13-14). Smith’s claim 15 is drawn to a method of treating skin by applying to a skin surface a lotion comprising components i-v, and maintaining the composition on the skin surface for a time effective to deliver the therapeutic agent to the skin.
Smith does not teach the step of applying the composition to the skin again after removing the mask sheet.
The teachings of Parrinello are related to skin treatment formulations and methods (Title and Abstract). The best mode treatment comprises a water broth cleansing and pre-wetting step, an activating serum step, a mask step to entrap active ingredients against the skin, and finally a sealing cream is applied. Treatments may use any single step or combination of steps. The selected treatments may also be combined with formulations from other inventors and commercial formulations to synergistically improve their performance (paragraph 0010). The final treatment step after removal of the mask is application of a sealing and moisturizing cream. As for the other treatment formulations, the cream is prepared of selections from primary categories noted for particular efficacy or known effective ingredients. The cream provides a longer term application of the effective ingredients in yet another formulation matrix (paragraph 0044). Paragraph 0053 provides a detailed description of the treatment steps.
The teachings of Behr, Smith, and Parrinello are related to compositions for treating skin and skin treatment methods, and it would have been obvious to have combined them because they are in the same field of endeavor.
It would have been prima facie obvious to a person of ordinary skill in the art to have formulated Behr’s composition as a lotion because Behr teaches that the dermatological formulation for topical administration may be formulated as a lotion (paragraph 0159). It would have been obvious to have impregnated the lotion into a sheet and applied the sheet to the skin, with a reasonable expectation of success because Smith teaches that a lotion may be applied to the skin by hand or by means of an absorbent fibrous or cellular sheet material that is impregnated with the composition. The selection of a known method of applying lotion based on its suitability for its intended purpose supports obviousness. One of skill would have been motivated to apply the lotion impregnated in a sheet because Smith teaches when a sheet impregnated with lotion is pressed or rubbed against the skin surface, an effective amount of the composition is released and coated onto the skin without skipping or separating on the skin. Smith further teaches that the lotion incorporated into an absorbent sheet retains sufficient
amounts of the lotion to effectively apply the lotion to the surface of the skin without leaking or bleeding during storage of the sheet or administration of the lotion to the skin. These teachings provide motivation to apply the lotion impregnated in a sheet.
It would have been obvious to have removed the sheet mask after a predetermined period of time, followed by applying a sealing moisturizing cream to the skin, with a reasonable expectation of success because Parrinello teaches a skin treatment method which requires the step of applying a sealing moisturizing cream after removing a mask from the skin. It would have been obvious to have formed the sealing moisturizing cream using Behr’s therapeutic agent, isolated exosomes, because Parrinello teaches that the purpose of the sealing cream is to provide a longer term application of the effective ingredients in yet another formulation matrix. The effective ingredient in Behr’s method is the juice extracted from Nepeta cataria which contains exosomes, which were isolated from the plant by the juicing process. Parrinello’s method of treating skin was known in the art and it would have been obvious to have utilized it in Behr’s treatment method because application of the sealing cream provides an extended exposure of the skin to the therapeutic agent after the mask is removed. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Response to Arguments
Applicant’s arguments submitted in the remarks dated June 18, 2026, were fully considered but are not persuasive for the following reasons.
The phrase “isolated exosomes” is not defined by the application. The phrase does not limit exosomes to any degree of purity or isolation method by which the exosomes were obtained. Behr’s juice extract contains exosomes which reads on isolated exosomes. The phrase does not exclude a bulk solubilized extract and the claims do not exclude a bulk solubilized extract.
As evidenced by bottom of page 11 of the instant specification, exosomes are present in juice extracted from the plant. The plant was cut into pieces and juiced. The juice is subsequently further purified as described by top of page 12 of specification. Behr also teaches cutting the plant into pieces followed by juicing. It would have been reasonable to expect the juice in Behr to contain exosomes because it was obtained in the same way as applicant’s specification. Behr does not have to mention exosomes because exosomes are naturally present in the plant and as evidenced by applicant’s specification, exosomes are present in the juice extracted from the plant. All properties of the exosomes would have been present in Behr because the juice contains exosomes. Behr is not required to teach exosome properties.
As explained above, “isolated exosomes” is not defined by the specification. The phrase does not imply any degree of purity or structure. Behr extracted juice from the plant which contains exosomes, as evidenced by applicant’s specification, which renders isolated exosomes obvious because the juice and exosomes contained therein are isolated from the plant. Thus, Behr’s composition contains isolated exosomes.
The claimed composition is described as “comprising” claimed components, which means that the composition is open to containing unrecited components. It is irrelevant that Behr’s composition contains other plant components in the extract. The claims do not exclude any other plant constituents, and besides exosomes, the phrase “isolated exosomes” does not imply presence or absence of any other plant constituents. It is not clear what the applicant is attempting to encompass by “isolated exosomes” and what is applicant attempting to exclude from the claimed composition. The extraction and purification methods on pages 10 and 11 are not claimed limitations, therefore it is irrelevant that Behr does not teach purification method.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). All claimed limitations and reasons to combine elements are present in the prior art reference.
Dependent claims remain rejected because independent claim 1 is not allowable.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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