The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 18, 2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 1-4, 6-11, 13 are canceled. Claims 5, 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
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, 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 KR ‘995 (KR20060125995; IDS 08.10.22, previously cited), Savić et al. (2010 Expert Opin Drug Deliv 7(3): 353-369; previously cited) and Park et al. (2018 Korean Polymer Society Polymers 42(2): 330-338, only abstract cited herein; previously cited).
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 that the starfish collagen peptide is obtained by an alkali treatment step of starfish and an enzyme treatment step of the starfish proteins/collagen to extract the effective component being the collagen peptide (at least p. 2-3). 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 explicitly teach that the obtained collagen peptide has a molecular weight (MW) 1550-1700 Da and that a glucoside-based surfactant is cetearyl glucoside.
KR ‘995 also discloses a method for obtaining starfish collagen peptide comprising an alkali treatment step and an enzyme treatment step (at least p. 1-2). KR ‘995 discloses that collagen (atelocollagen) is not applicable to cosmetics because a molecular weight about 100,000 is not absorbed by the skin (at least p. 3). KR ‘995 discloses that in order to solve this problem, it is necessary to decompose the atelocollagen into a low molecular weight peptide having a MW of 3000 Da or less (at least p. 3). KR ‘995 discloses that after enzyme treatment, low MW collagen peptide having a MW of 1000-3000 Da is obtained (at least p. 4).
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, where the MW of the starfish collagen peptide of KR ‘799 is optimized to be a low MW 1000-3000 Da, as suggested in KR ‘995, 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, wherein the surfactant is cetearyl glucoside, wherein the starfish-derived collagen peptide has a MW of 1550-1700 Da (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 and that starfish derived collagen peptides having a low MW of 3000 Da or less (1000-3000 Da) are applicable to cosmetics and absorbed by the skin. 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 and collagen peptides having low MW less than 3000 Da are better absorbed by the skin.
Regarding the additional recited limitation “wherein the starfish-derived collagen peptide contains 38% or more of hydrophilic amino acids” (instant claim 5), KR ‘799 discloses that the obtained active component comprises a hydrophilic collagen peptide (at least p. 3). Therefore, KR ‘799 can be deemed to disclose that the obtained starfish collagen peptide contains >38% hydrophilic amino acids.
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 claims remain unpatentable under 103 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, together with starfish-derived collagen peptide having a hydrophilic amino acid content of 38% or more and a MW range in a range of 1550-1700 Da. Applicants point to the examples and tables 18-20 of the specification. Applicants assert that the instantly recited starfish-derived collagen peptide contains a relatively large hydrophilic amino acid content of 38% or more, which is significantly higher than that of pig skin or fish peptides, which contains about 25-27% of hydrophilic amino acids (see Table 1 paragraph 61 of the instant specification). Applicants assert that as a result of the higher hydrophilic amino acid content, the instantly recited starfish-derived collagen peptide can be loaded into the elastic liposome with superior carrying efficiency, as compared with pig skin collagen peptide or fish collagen peptide.
Applicants’ remarks are not persuasive. In this instance, KR ‘799 discloses that the extract obtained from starfish, after the alkali treatment step and enzyme treatment step, contains an active ingredient comprising a hydrophilic collagen peptide and an amphipathic collagen peptide (at least p. 3). Since KR ‘799 discloses that the active component obtained in the starfish extract comprises a hydrophilic collagen peptide, KR ‘799 can be deemed to disclose that the starfish collagen peptide contains >38% hydrophilic amino acids. Therefore, KR ‘799 can be deemed to disclose a starfish collagen peptide that is structurally similar and/or the same as the claimed starfish collagen peptide, and therefore, any recognized advantage of loading efficiency in a liposome as asserted by Applicants, would follow from the teachings of the prior art since KR ‘799 discloses starfish collagen peptides are effective for preventing skin aging (p. 1-2) incorporating the starfish-derived collagen peptides into liposomes (p. 2-6). See also MPEP 2145, which notes that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.
Applicants assert that furthermore, the instant recited starfish-derived collagen peptide has a MW in a range of 1550-1700 Da, thereby allowing it to exhibit superior skin penetration properties (see paragraph 51 of the instant specification). Applicants present experimental data (Applicants’ remarks p. 8-9) and assert that specifically, when the molecular weight of the starfish-derived collagen peptide is within the range of 1550-1700 Da, the carrying efficiency reaches as high as 88.3%, whereas when the molecular weight is outside the above range, the carrying efficiency is significantly reduced.
Applicants’ remarks are not persuasive.
In this instance, the prior art KR ‘995 has also recognized that it is necessary to decompose starfish derived collagen into collagen peptides having a low MW of 3000 Da or less (p. 3) to achieve skin absorption. As noted above, KR ‘995 discloses that collagen (atelocollagen) is not applicable to cosmetics because a molecular weight about 100,000 is not absorbed by the skin (at least p. 3). KR ‘995 discloses that in order to solve this problem, it is necessary to decompose the atelocollagen into a low molecular weight peptide having a MW of 3000 Da or less (at least p. 3). KR ‘995 discloses that after enzyme treatment, low MW collagen peptide having a MW of 1000-3000 Da is obtained (at least p. 4).
As also noted above, KR ‘799 discloses that the starfish collagen peptide is obtained by the same treatment steps disclosed in KR ‘995, including an alkali treatment step of starfish and an enzyme treatment step of the starfish proteins/collagen to extract the effective component being the collagen peptide (KR ‘799 at least p. 2-3; KR ‘995 p. 1-4). Therefore, the active component comprising starfish hydrophilic collagen peptide in KR ‘799 can be deemed to be an optimized hydrophilic collagen peptide having a low MW 1000-3000 Da, as suggested in KR ‘995, thereby including the recited MW 1550-1700 Da.
It is also known that MPEP 716.01(c) notes that objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.
Further, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.
Regarding Applicants’ previous 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 hydrophilic collagen 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 claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656
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