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 Applicants’ amendments/remarks received February 25, 2026.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 1-4, 7-10, 13 are canceled. Claims 5-6, 11-12, 14 are under consideration.
Priority: This application is a 371 of PCT/KR2021/005972, filed May 12, 2021, which claims benefit to foreign application KR 10-2020-0059674, filed May 19, 2020. A copy of the foreign priority document has been received in the instant application on August 10, 2022, and is not in the English language.
Objections and Rejections
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: the Figure does not include the reference number “1” or “Figure 1” as noted in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant is advised that should claim 5 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In this instance, claim 11 is a product claim comprising the same components recited in claim 5. Claim 11 does not recite any additional components to the product that distinguish or differentiate it from the product of claim 5. The recitation of an intended use (i.e. cosmetic composition) in claim 11 in a product does not further limit the claim and the product still comprises the same material features and components as the product of claim 5.
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.
Claims 5-6, 11-12, 14 are rejected under 35 U.S.C. 103 as being unpatentable over KR ‘799 (KR101640799; IDS 08.10.22) (translation copy provided by Google Patents cited herein; previously cited) in view of Savić et al. (2010 Expert Opin Drug Deliv 7(3): 353-369) and Park et al. (2018 Korean Polymer Society Polymers 42(2): 330-338, only abstract cited herein).
KR ‘799 discloses a method comprising obtaining a starfish collagen peptide and formulating a composition comprising a phospholipid layer comprising phospholipids and surfactant, the starfish collagen peptide being in the formulated vesicle (at least p. 2-3), the vesicles having a particle size including 200 nm (at least p. 5-6), where the surfactant is selected from among others dodecylglucoside, heptylglucoside (at least p. 3-4). KR ‘799 discloses a cosmetic composition comprising the vesicles comprising starfish collagen peptide (at least p. 6). KR ‘799 discloses the starfish collagen peptides are effective for preventing skin aging (at least p. 1-2) and disclose the composition comprising the starfish collagen peptide vesicles are used for external application of the skin (at least p. 5). Therefore, KR ‘799 can be deemed to disclose a liposome comprising a phospholipid layer comprising phospholipids and a surfactant, and a starfish-derived collagen peptide inside the phospholipid layer, wherein the elastic liposome has a particle of 200 nm, and wherein the surfactant is a glucoside-based surfactant. KR ‘799 does not teach a cetearyl glucoside.
Savić et al. disclose surfactants play an important role in the development of both conventional and advanced drug delivery systems; depending on their structure and physicochemical properties, surfactants can alter properties including solubility, diffusion, disintegration; where by affecting these parameters, surfactants influence the rate and extent of drug absorption (at least p. 353-354). Savić et al. disclose alkyl polyglucosides (APGs) are of pharmaceutical importance, exhibit peculiar physicochemical behavior (pH stability/sensitivity, specific interfacial properties/adsorption phenomenon and phase transition, temperature insensitivity, i.e. microemulsions forming independent on temperature…) and favorable safety profiles (particularly in dermatological and ocular use) (at least p. 354). Savić et al. disclose that at present, the most exploited natural surfactant in the formulation for topical vehicles is the APG-type surfactant cetearyl glucoside with cetearyl alcohol (at least p. 357). Savić et al. disclose that in studies with APG as an alternative surfactant/stabilizer, in the preparation of peptide-loaded nanoparticles, APG based on decyl polyglucoside was used as a representative surfactant (at least p. 364). Savić et al. disclose that APG provided an excellent stabilization effect, resulting in nanoparticles with better encapsulation efficiency and a particle size < 400 nm (at least p. 364). Savić et al. further disclose that in formulations of microemulsions, APG-based surfactants are chosen for their outstanding biodegradability, excellent dermatological properties and good surface-active characteristics (at least p. 365).
Park et al. further disclose preparing an elastic liposome composed of phospholipids and the surfactant cetearyl glucoside as a skin delivery system (abstract). Park et al. disclose elastic liposomes having cetearyl glucoside exhibited higher skin permeability than the conventional liposomes without cetearyl glucoside (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the surfactant cetearyl glucoside of Savić et al./Park et al. for the surfactant in the liposome comprising phospholipids and starfish collagen peptide of KR ‘799 noted above to thereby arrive at the claimed liposome comprising a phospholipid layer comprising phospholipids and a surfactant, and a starfish-derived collagen peptide inside the phospholipid layer, wherein the elastic liposome has a particle of 200 nm, and wherein the surfactant is cetearyl glucoside (instant claim 5). The motivation to do so is given by the prior art, which disclose cetearyl glucoside is the most exploited natural surfactant in formulations for topical vehicles, having excellent dermatological properties including exhibiting higher skin permeability in a delivery system with liposomes. One of ordinary skill would have a reasonable expectation of success because the prior art discloses the advantageous properties of cetearyl glucoside as a surfactant in dermatological formulations including delivery systems with liposomes.
Regarding instant claim 6, KR ‘799 discloses that the collagen peptides obtained from starfish include hydrophilic collagen peptides (at least p. 3). Therefore, KR ‘799 can be deemed to disclose that the starfish collagen peptide obtained has >30% hydrophilic amino acids.
Regarding instant claim 11, KR ‘799 discloses a cosmetic composition comprising the vesicles comprising starfish collagen peptide (at least p. 6). Therefore, it would have been obvious to formulate the liposome comprising phospholipids and starfish collagen peptide and cetearyl glucoside of KR ‘799 in view of Savić et al./Park et al. noted above into a cosmetic composition.
Regarding instant claims 12, 14, KR ‘799 discloses the starfish collagen peptide is obtained from starfish that has been treated with an alkali solution and then an enzyme treatment, where the pH of the solution for enzyme treatment includes adjusting with an acid selected from citric acid (at least p. 3). Therefore, KR ‘799 can be deemed to disclose a starfish collagen peptide that is structurally the same as the claimed starfish collagen peptide. KR ‘799 discloses the starfish collagen peptides are effective for preventing skin aging (at least p. 1-2) and disclose the composition comprising the starfish collagen peptide vesicles are used for external application of the skin (at least p. 5). Therefore, KR ‘799 can be deemed to disclose methods for improving skin wrinkles, which would include anti-oxidation, comprising administering the composition comprising the starfish collagen peptide vesicles to a subject in need thereof. Therefore, it would have been obvious to administer a composition comprising the liposome comprising phospholipids and starfish collagen peptide and cetearyl glucoside of KR ‘799 in view of Savić et al./Park et al. noted above for improving skin wrinkles and treating anti-oxidation to a subject in need thereof (instant claims 12, 14).
Reply: In view of Applicants’ amendments/remarks, the previous 102(a)(1) rejection as being anticipated by KR ‘799 has been withdrawn. However, KR ‘799 is cited in a new 103 rejection in view of newly cited Savić et al. and Park et al. for the reasons noted above and herein.
Applicants assert that the instant claims are presently directed to an elastic liposome comprising a phospholipid layer comprising phospholipids and a surfactant that is cetearyl glucoside. Applicants assert that the elastic liposome recited in the instant claims exhibit excellent loading efficiency, a small particle size, and high skin adsorption efficiency by the inclusion of cetearyl glucoside as a surfactant. Applicants point to the examples and tables 18-20 of the specification. Applicants assert that KR ‘799 merely mentions dodecylglucoside and heptylglucoside as surfactants.
Applicants’ remarks are not persuasive. The deficiency of KR ‘799 to not explicitly teach cetearyl glucoside is remedied by newly cited Savić et al. and Park et al. See the 103 rejection above.
As noted above, KR ‘799 fairly discloses a liposome comprising a phospholipid layer comprising phospholipids and a surfactant, and a starfish-derived collagen peptide inside the phospholipid layer, wherein the elastic liposome has a particle of 200 nm, and wherein the surfactant is a glucoside-based surfactant. KR ‘799 differs from the claimed liposome by not teaching that the glucoside-based surfactant is cetearyl glucoside.
However, Savić et al. disclose that APG-type surfactant cetearyl glucoside with cetearyl alcohol is the most exploited natural surfactant in the formulation for topical vehicles (at least p. 357). Savić et al. disclose that in peptide-loaded nanoparticles with APG (i.e. an APG based on decyl polyglucoside) as an alternative surfactant/stabilizer, the APG provided an excellent stabilization effect, resulting in nanoparticles with better encapsulation efficiency and a particle size < 400 nm (at least p. 364). Park et al. also disclose preparing an elastic liposome composed of phospholipids and the surfactant cetearyl glucoside as a skin delivery system (abstract). Park et al. disclose elastic liposomes having cetearyl glucoside exhibited higher skin permeability than the conventional liposomes without cetearyl glucoside (abstract).
Therefore, it would have been obvious to one of ordinary skill to incorporate the surfactant cetearyl glucoside of Savić et al./Park et al. for the surfactant in the liposome comprising phospholipids and starfish collagen peptide of KR ‘799 noted above to thereby arrive at the claimed liposome comprising a phospholipid layer comprising phospholipids and a surfactant, and a starfish-derived collagen peptide inside the phospholipid layer, wherein the elastic liposome has a particle of 200 nm, and wherein the surfactant is cetearyl glucoside (instant claim 5). The motivation to do so is given by the prior art, which disclose cetearyl glucoside is the most exploited natural surfactant in formulations for topical vehicles, having excellent dermatological properties including exhibiting higher skin permeability in a delivery system with liposomes. One of ordinary skill would have a reasonable expectation of success because the prior art discloses the advantageous properties of cetearyl glucoside as a surfactant in dermatological formulations including delivery systems with liposomes.
Regarding Applicants’ remarks on the superior properties of the elastic liposomes having cetearyl glucoside as the surfactant, the remarks are not persuasive. In this instance, the prior art already discloses that cetearyl glucoside has the same superior properties noted by Applicants. Savić et al. already disclose that APG-type surfactant cetearyl glucoside with cetearyl alcohol is the most exploited natural surfactant in the formulation for topical vehicles (at least p. 357) and that APG provides an excellent stabilization effect, resulting in nanoparticles with better encapsulation efficiency and a particle size < 400 nm (at least p. 364). Additionally, Park et al. also demonstrate the enhanced or higher skin permeability of a skin delivery system comprising cetearyl glucoside as the surfactant and the liposomes similarly disclosed in KR ‘799 and the instant claims.
MPEP 716.02(b) notes that Applicant has the burden to establish that the results are unexpected and significant. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See also MPEP 716.02(e) noting that the claimed subject matter has to be compared with the closest prior art to be effective to rebut a prima facie case of obviousness.
In this instance, Applicants have not provided a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. The closest prior art is the skin delivery system comprising liposomes and cetearyl glucoside of Park et al. or the skin delivery system comprising liposomes, starfish peptide, and surfactant in the examples of KR ‘799.
For at least these reasons, the claims are unpatentable under 35 U.S.C. 103.
No clam is allowed.
THIS ACTION IS MADE FINAL. 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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/Marsha Tsay/Primary Examiner, Art Unit 1656