DETAILED ACTION
The present application is a national stage entry of PCT/KR2022/000338, filed 07 January 2022, and claims priority to KR10-2021-0002116, filed 07 January 2021.
The preliminary amendment filed 30 June 2023 is acknowledged. Claims 1-23 are pending in the current application. Claims 9-14, 21 and 23 are withdrawn as being drawn to a non-elected invention, see below. Claims 1-8, 15-20 and 22 are examined on the merits herein.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, 15-20 and 22 in the reply filed on 05 December 2025 is acknowledged.
Claims 9-14, 21 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 December 2025.
Applicant’s election without traverse of mannitol as a species of polyol in the reply filed on 05 December 2025 is acknowledged.
Although the elected species is rejected under 35 U.S.C. §103(a) obviousness, to advance prosecution of this application, the Examiner has included a search of the species: sucrose, and a glucose derivative (ascorbic acid 2-glucoside).
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.
Claim(s) 1-5, 7, 8, 15-20 and 22 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Liu et al. (US Patent Application Publication No. 2021/0023265, cited in PTO-892).
Liu et al. disclose a dermal filler composition comprising a crosslinked hyaluronic acid (HA) and an agent covalently conjugated to the crosslinked HA, wherein the agent is selected from a vitamin, an antioxidant, a growth factor, or a peptide (claim 1). The HA comprises no more than about 20% w/w of a high molecular weight HA having a molecular weight of between about 1,000,000 and about 3,000,000 Daltons (claim 6; see para [0050]). The agent is directly conjugated to the HA via 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC), (claim 13). The antioxidant is a polyol (claim 15). Crosslinking agents include BDDE (para [0052]). A preferable antioxidant is a vitamin C derivative, including L-ascorbic acid 2-glucoside (AA2G, i.e. 13 carbon atoms), (para [0015]):
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(fig. 1). The HA has a degree of conjugation of 5-40 mol% (para [0019]). The HA has a gel concentration varying from 17-26 mg/mL (fig. 8); also reported as mg/g (see para [0055]). The dermal filler is injectable, and has antiaging activity by functioning as a radical scavenger (see e.g. para [0022]). The dermal filler was used for treating wrinkles (example 25). The dermal filler further comprises an anesthetic agent, including lidocaine (claims 18 and 19). The composition further comprises a pharmaceutically acceptable buffer, osmolality adjusting agents and tonicity adjuster (i.e. isotonic agent) (para [0119] and [0120]). The composition can be administered via a syringe, where example 1 describes filling a syringe with the gel (para [0133]; example 1). In example 1, HA was hydrated in a syringe with alkali solution, after which AA2G and BDDE were allowed to react before being added to the hydrated HA. A HA-AA2G gel was formed.
Thus, Liu et al. disclose a hyaluronic acid hydrogel comprising hyaluronic acid, a crosslinking agent and a polyol, wherein the HA is crosslinked with the crosslinking agent and polyol.
Thus, the disclosure of Liu et al. anticipates claims 1-5, 7, 8, 15-20 and 22 of the present application.
Claim(s) 1-6, 15, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suner et al. (International Journal of Biological Macromolecules, 2019, vol. 126, pp. 1150-1157, cited in IDS submitted 30 June 2023).
Suner et al. disclose preparing a hyaluronic acid (HA) nanogel crosslinked with a crosslinking agent and sucrose (i.e. a polyol, also known as saccharose per present claim 6), (abstract; p.1151, section 2.2). HA in alkali solution was mixed with sucrose, followed by the addition of glycerol diglycidyl ether (GDE; i.e. reads on glycerol polyglycidyl ether per present claim 4) crosslinker (p.1151, section 2.2). The HA has a molecular weight of 1,000,000 Da (p.1151, 2.1). Suner et al. disclose a composition comprising the gels in phosphate buffer solution (p.1151, section 2.3, i.e. a buffer solution and an isotonic agent).
The recitation “filler” in present claim 15 is an intended use of the composition, and does not appear to require any structural limitation not currently claimed. Similarly, the recitation “for skin injection” in present claim 16, and “for wrinkle improvement…” in present claim 17 are an intended use of the composition.
Thus, Suner et al. disclose a hyaluronic acid hydrogel comprising hyaluronic acid, a crosslinking agent and a polyol, wherein the HA is crosslinked with the crosslinking agent and polyol.
Thus, the disclosure of Suner et al. anticipates claims 1-6, 15, 16 and 20 of the present application.
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.
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.
Claim(s) 1-8, 15-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US Patent Application Publication No. 2021/0023265, cited above) in view of Andre et al. (International Journal of Cosmetic Science, 2017, vol. 39, pp. 355-360, cited in PTO-892).
Liu et al. teach as discussed above.
Liu et al. do not expressly disclose maltitol (present claim 6).
Andre et al. teach mannitol has hydrating and antioxidant properties, making it ideal when combined with HA fillers (abstract). Andre et al. teach mannitol reduces the inflammation and swelling associated with injection, and prevents the degradation of the injected HA by free radicals (abstract). The addition of mannitol to HA fillers is a viable and safe option for improving short- and long-term HA aesthetic effects. Andre et al. teach vitamin C is a known natural defense mechanism used by mammalian cells as a defense mechanism to detoxify radicals (p.355-356, bridging para). Mannitol has been used as a diluent in pharmaceutical formulations, and is safe in injectable formulations (p.357). Andre et al. teach multiple HA-based dermal fillers having mannitol already exist, wherein the mannitol improved hydration effects, decreased HA depolymerization, improved skin quality, and has been used to treat wrinkles (p.358, right col to p.359). Andre et al. teach “the high degree of cross-linking in Etermis® 3 in combination with the free radical scavenging properties of mannitol acts in concert to limit early hydroxyl radical degradation of the product and contribute to its long-lasting aesthetic effect” (p.359, penultimate para).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate a crosslinked HA hydrogel, wherein the HA is crosslinked with a crosslinking agent and mannitol.
Starting from Liu et al., the ordinary artisan would have looked to the teachings of Andre et al. because they are both concerned with preparing HA-based dermal fillers having antioxidant properties. The ordinary artisan would have been motivated to substitute the vitamin C derivative with mannitol in the HA-AA2G crosslinked dermal filler of Liu et al., because both vitamin C and mannitol are polyols and recognized as alternative antioxidants. Furthermore, mannitol was found to also have hydrating properties, which is particularly beneficial for their use as an aesthetic agent. Thus, they both share similar chemical functional groups and similar functional properties as antioxidants. The ordinary artisan would have had a reasonable expectation of success because mannitol is suitable for injection, and has been used in combination with HA-crosslinked dermal fillers.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699