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 .
Election/Restrictions
Applicant’s election without traverse of Invention 1, claims 1-9, in reply filed on 10/28/2025 is acknowledged.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/28/2025.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites “pHs” which is a minor informality.
Appropriate correction is required.
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 and 9 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.
Claim 2 recites “wherein a content ratio of the cica extract and microneedles is 0.5 to 2: 98 to 99.5 parts by weight.” This is indefinite because it is unclear which number in the ratio is assigned to cica extract. For the purposes of examination the ratio will be interpreted as cica extract to microneedles (i.e., cica extract : microneedles at a ratio of 0.5-2:98-99.5).
The phrase “expedites improvement” in claims 8 and 9 are relative phrases which renders the claim indefinite. The phrase “expedites improvement” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what base improvement the claimed improvement is compared in order to establish an expedited improvement.
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.
Claims 1, 5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harp (Harp Corporation; “Essence”, July 2022, Mintel, Https://www.gnpd.com/sinatra; cited in IDS 10/27/2025).
Harp discloses a composition comprising spicules extracted from sponges [p. 1, para. 1, lines 3-4] and “cica to prevent roughness” [p. 1, para. 1, lines 5-6].
According to the instant specification “[t]he microneedle of the inventive concept may be a spicule” [0014].
One would have expected the spicules of the prior art to be impregnated with the cica extract because they are both mixed in the composition together. Thus, the prior art anticipates instant claims 1, 5 and 7-9 because it discloses a composition comprising a microneedle (spicule) and cica extract, wherein the microneedles originate from a sponge. Since the prior art composition contains substantially the same components, i.e., cica extract and microneedles, it would be expected to inherently possess the same chemical and physical properties, e.g., improves a turn-over of skin, and expedites improvement of a regeneration of skin and skin roughness.
Claims 1, 5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR ‘730 (KR 102265730 B1, publication date 06/17/2021; citing machine English translation).
KR ‘730 discloses a composition comprising centella asiatica extract [p. 14, Example 2, lines 12 and 14] and hydrolyzed sponge [p. 14, Example 2, lines 17-18]. According to KR ‘730 hydrolyzed sponge are spicules [p. 10, para. 7].
According to the instant specification centella asiatica extract is cica extract [0013] and spicules are microneedles [0014].
One would have expected the spicules of the prior art to be impregnated with the cica extract because they are both mixed in the composition together. Thus, the prior art anticipates instant claims 1, 5 and 7-9 because it discloses a composition comprising a microneedle (spicule) and cica extract, wherein the microneedles originate from a sponge. Since the prior art composition contains substantially the same components, i.e., cica extract and microneedles, it would be expected to inherently possess the same chemical and physical properties, e.g., improves a turn-over of skin, and expedites improvement of a regeneration of skin and skin roughness.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable Pamornpathomkul et al. (MATEC Web Conference, 2018, Volume 192) in view of Kim et al. (Journal of Cosmetic Dermatology, 01/16/2022, vol. 21, p. 4754-5764).
Regarding instant claims 1 and 5-9, Pamornpathomkul discloses “[i]t is challenging to deliver molecules into the skin because of the foremost barrier from the stratum corneum of skin [5]. Therefore, improved delivery strategies are necessary to solve this issue” [p. 1, col. 1, para. 2, lines 1-4]. To solve this Pamornpathomkul studied “liposome and niosome for in vitro skin permeation and antioxidant activity of Centella asiatica (CA) extract” and found “that liposome had a superior enhancing effect on skin permeation compared to niosome, gel and solution formulation” [p. 1, abstract, lines 2-3 & lines 6-7].
According to the instant specification centella asiatica extract is cica extract [0013].
Pamornpathomkul does not disclose microneedles.
Kim relates to a novel dermal delivery system [title]. Kim discloses first isolating needle-like spicules from fresh water sponges (Spongilla lacustris [p. 4756, col. 2, last sentence]), then loading those spicules with an active agent encapsulated in a liposome [p. 4754, abstract, ‘Methods’]. “A model ingredient, pectolinarin, was efficiently loaded onto the internal space of spicules via lecithin-based liposome formations” [p. 4754, abstract, ‘Methods’]. Pectolinarin “is a primary phytochemical among the flavonoids isolated from wild herbs inclusive of Cirsium setidens” (i.e., is a plant extract) [p. 4760, col. 2, penultimate paragraph]. Kim discloses “[t]he delivery of ingredients loaded on spicules is assessed to improve the dermal efficacy compared to simple topical treatments” [p. 4754, abstract, ‘Aims’]. Specifically, Kim compares the dermal absorption of Nile-red containing liposomes and Nile-red containing liposomes involving spicules, by measuring the accumulated fluorescence from the Nile red, after application [p. 4759, Figure 4]. “The accumulated fluorescence intensity was approximately 5 times higher in the use of spicules as a delivery vehicle” as compared to the Nile-red containing liposomes alone [p. 4758, col. 2, para. 1, lines 2-4].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have applied to known technique disclosed by Kim to the known composition disclosed by Pamornpathomkul. One would have been motivated to do so to further enhance skin permeation, as desired by Pamornpathomkul. One would have had an expectation of success because both disclosures relate to topical delivery of a cosmetic actives, and Kim specifically discloses a liposomal plant extract as the “model drug”. Furthermore, considering Kim discloses the spicules enhance dermal absorption of liposomal actives, one would have recognized the liposomal cica extract of Pamornpathomkul, loaded into spicules according to Kim, would have yielded predictable results and an improved system of delivery. See MPEP 2143, Exemplary Rationale D.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising microneedles impregnated with cica extract. Wherein the microneedles originate from Spongilla lacustris. Since the prior art composition contains substantially the same components, i.e., cica extract impregnated microneedles, it would be expected to inherently possess the same chemical and physical properties, e.g., improves a turn-over of skin, and expedites improvement of a regeneration of skin and skin roughness.
Regarding instant claim 2, Kim discloses a “general serum formulation was prepared, inclusive of spicules (2.0%), loaded with liposomes that contain pectolinarin (1500 ppm)” (i.e., a ratio of about 0.15:2 or about 7.35:98 microneedles:active) [p. 4758, col. 1, para. 4, lines 1-2].
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case, one would have been motivated to optimize ratio of active to spicule because the “normal desire of scientists to improve upon what is already generally known”. Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382. Please refer to MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have optimized the ratio of the prior art to reach the instantly claimed ratio.
Regarding instant claim 3 and 4, Kim discloses the spicules were “fully characterized to appear 250 μm of length and 12 μm of diameter on average” [p. 4754, abstract, ‘Results]. Kim also discloses the spicules “were washed with deionized water (1 L) and then a series of 2% L-ascorbic acid solution (1 L) until the pH of mixture indicates below 8” [p. 4755, col. 2, para. 2, lines 3-6].
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case the claimed ranges for the microneedles (200-300 microns by 10-20 microns) and pH (7-8) overlap with the ranges of the prior art (250 microns by 12 microns, and a pH below 8), and so a prima facie case of obviousness exists for each.
Conclusion
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612