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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 17, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1 – 13 are examined here-in.
Claim Objections
Claims 1 – 13 are objected to because of the following informalities:
There are multiple misspellings: “hyaluromic acid” should be “hyaluronic acid”.
Claims 4 and 9 list ingredients and amounts, however, should be reformatted to be a list i.e. “astaxanthin in an amount of 0.05 – 0.3 parts, hydrophilically modified resveratrol in an amount of 0.1 – 0.3 parts…” The present formatting of these claims begins as a sentence, however, following the colon, punctuation and linking words are missing. Furthermore, all claims should end with a period per MPEP 608.01(m).
In claim 7 “the cosmetic effects comprising anti-photoaging effects” is a dependent clause that needs a linking term such as “and” or “wherein” to precede it.
Specification
The disclosure is objected to because of the following informalities:
“hyaluromic acid” should be “hyaluronic acid”.
On page 7, lines 17 and 18 “weight” should be the verb “weighed.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 non-obviousness.
Claims 1 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 2022/0072289 A1) in view of Quan (US 2021/0214588 A1) and further in view of Kim (US 2007/0009455 A1).
Liu teaches that microneedles penetrate the skin to provide cosmetic effects, such as reducing wrinkles (paragraphs 0343 – 0346).
Liu teaches a microneedle patch with a base layer and a plurality of dissolvable cone-shaped microneedles (paragraphs 0011 – 0013, 0115, 0350, 0351, claim 15). Liu teaches the microneedles are cone-shaped with a needle length of 250 µm and a base diameter of 300 µm (paragraph 0014, 0351). Liu teaches the density of microneedles is in a range of 100 to 2,000 microneedles per cm2 (paragraph 0087).
Liu teaches that the microneedles may comprise water-soluble polymer hyaluronic acid in the amount of 50% by weight or more and cosmetic active ingredients in the amount of 0.01 to 10% by weight (paragraphs 0064 – 0067, 0072, 0111).
Liu teaches the microneedle patch is for application to the face (paragraphs 0041, 0046, 0083, 0162, 0165, 0337) and that the one or more cosmetic ingredients may be anti-aging ingredients (paragraphs 0107 – 0109).
Liu does not teach astaxanthin, hydrophilically modified resveratrol, or collagen.
Quan teaches a missing element of Liu.
Quan discloses microneedle patches with hyaluronic acid or collagen as biosoluble polymer materials that dissolve into the skin, leading to anti-wrinkle activity or delivery of an additional cosmetic ingredient (paragraph 0005). Quan teaches astaxanthin, resveratrol, and collagen as active cosmetic ingredients (paragraphs 0072 – 0074, 0080).
The combination of Liu and Quan’s teachings is prima facie obvious as combining known elements to yield predictable results (MPEP 2143(I)(a)). A person of ordinary skill in the art would have been motivated to combine the teachings of Liu and Quan for a microneedle patch with hyaluronic acid, collagen, astaxanthin, and resveratrol because Quan teaches that these ingredients lead to anti-wrinkle and whitening activity (paragraphs 0005, 0073, 0074).
The combination of Liu and Quan does not teach that resveratrol is hydrophilically modified.
Kim teaches the missing element of the combination of Liu and Quan.
Kim teaches a cosmetic composition containing resveratrol and cyclodextrin (abstract).
Kim teaches that resveratrol has excellent antioxidative effects, however, often precipitates in cosmetic compositions (paragraph 0009). Kim discloses cyclodextrin as a stabilizer for resveratrol, and teaches resveratrol in the amount of 0.001 – 10% by weight and cyclodextrin and the amount of 0.1 to 50% by weight of the composition (paragraphs 0015 – 0018, 0027). Kim teaches that the cyclodextrin is preferably hydroxypropyl-beta-cyclodextrin (paragraphs 0024, 0036).
Liu, Quan, and Kim’s teachings render claims 1 – 8 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(I)(a)). A person of ordinary skill in the art would have been motivated to modify the combination of Liu and Quan to include resveratrol with cyclodextrin as taught by Kim because Kim teaches that cyclodextrin acts as a stabilizer for resveratrol, thus ensuring it is soluble in a cosmetic composition (paragraphs 0009, 0015 – 0018, 0027). In the instant case, all the claimed elements (e.g., microneedle patch, astaxanthin, resveratrol, collagen, hyaluronic acid) were known in the prior art (e.g., cosmetic compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., cosmetic microneedle patch) to one of ordinary skill in the art.
Liu’s teaching for a microneedle patch with a base layer and a plurality of dissolvable cone-shaped microneedles (paragraphs 0011 – 0013, 0115, 0350, 0351, claim 15) in combination with Quan’s teaching to include astaxanthin, resveratrol, collagen, and hyaluronic acid in a microneedle patch (paragraphs 0005, 0072 – 0074, 0080) and further in view of Kim’s teaching to stabilize resveratrol with hydroxypropyl-beta cyclodextrin (paragraphs 0015 – 0018, 0024, 0027, 0036) reads on instant claim 1.
Kim’s teaching of hydroxypropyl-beta cyclodextrin to stabilize resveratrol (paragraphs 0015 – 0018, 0024, 0027, 0036) reads on the instantly claimed “hydrophilically modified resveratrol” because the instant specification describes hydrophilically modified resveratrol as resveratrol mixed with hydroxypropyl-beta-cyclodextrin on page 7. Kim’s teaching for resveratrol in the amount of 0.001 – 10% by weight and cyclodextrin and the amount of 0.1 to 50% by weight (paragraphs 0015 – 0018, 0027) reads on instant claims 2 and 3. Kim’s taught ranges of 0.001 – 10% resveratrol and 0.1 to 50% cyclodextrin by weight overlap on the instantly claimed ratio of 0.8 – 1.2 parts resveratrol to 9 – 12 parts cyclodextrin. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(I).
Liu’s teaching that the microneedles may comprise water-soluble polymer hyaluronic acid in the amount of 50% by weight or more (paragraphs 0064 – 0067, 0072) overlaps on the instantly claimed 70 – 97 parts hyaluronic acid as recited in claim 4. Further, Liu’s teaching for cosmetic active ingredients in an amount of 0.01 to 10% (paragraph 0111) overlaps on the instantly claimed amounts for astaxanthin, resveratrol, and collagen recited in claim 4.
Liu’s teaching that microneedles have a needle length of 250 µm and a base diameter of 300 µm (paragraph 0014, 0351) overlaps on the instantly claimed height of 30 to 350 µm and widest point of 100 to 400 µm as recited in claim 5. Although Liu does not teach the total height of the microneedle patch, Figure 1 suggests that the base layers are equal to or less than the length of the needles. As such, for a needle length of 250 µm, the total patch height would be 500 µm or less (Figure 1), overlapping on the instantly claimed total height of 200 to 500 µm as recited in claim 5.
Liu’s teaching that the density of microneedles is in a range of 100 to 2,000 microneedles per cm2 (paragraph 0087) overlaps on the instantly claimed range of 50 – 300 needles per cm2 as recited in claim 6.
Liu’s teaching that the microneedle patch is for application to the face (paragraphs 0041, 0046, 0083, 0162, 0165, 0337) and that the cosmetic ingredients may be anti-aging ingredients (paragraphs 0108 – 0109) reads on instant claim 7. Liu’s teaching for anti-aging ingredients is interpreted to read on photo-aging, which the instant specification describes as one contributor to skin aging that occurs due to exposure to the sun (page 1).
Liu’s teaching that the microneedles are cone-shaped (paragraphs 0011 – 0013, 0115, 0350, 0351, claim 15) reads on instant claim 8.
Claims 9, 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over McAllister (US 10,828,478 B2) in view of Souto (US 2010/0204179 A1).
McAllister teaches a method of making a microneedle patch that includes various substances of interest (abstract, column 12 lines 18 – 24).
McAllister teaches astaxanthin, resveratrol, cyclodextrin, collagen, and hyaluronic acid may be substances of interest to include in a microneedle patch (column 11 line 58, column 12 line 11, column 13 lines 14 and 16).
McAllister teaches a method of making microneedle arrays with a base layer and microneedles through a molding process (column 14 lines 53 – 65). McAllister teaches the substances of interest are mixed into solution with a solvent such as water (column 19 lines 37 – 45, 60). McAllister teaches the solution is transferred to a mold, then vacuum is applied (column 26 lines 12 – 20). McAllister teaches microneedles are dried, then removed from the mold (column 29 line 58 to column 30 line 3, lines 15 – 26).
McAllister teaches that microneedles can have a length between 50 µm and 2 mm and a width at the base of 20 to 1,000 µm (column 7 lines 46 – 49, column 8 lines 23 – 24). McAllister teaches the total thickness of the patch is preferably less than 0.5 cm or 5,000 µm (column 31 lines 5 – 8). McAllister teaches the microneedles are conical (column 32 line19).
McAllister does not teach making hydrophilically modified resveratrol.
Souto teaches the missing element of McAllister.
Souto teaches that complexing resveratrol with cyclodextrin increases the solubility of resveratrol, which enables higher concentrations of the antioxidant compound to be included in compositions (abstract).
Souto teaches a resveratrol/cyclodextrin complex is made by dissolving cyclodextrin in water ( 20 – 60 mM), then adding resveratrol in an appropriate solvent such as ethanol (20 to 80 mM), followed by mixing and cooling steps (paragraph 0048). Souto teaches the resulting resveratrol/cyclodextrin complex is precipitated, dried, and filtered (paragraph 0048).
The combination of McCallister and Souto’s teachings renders claims 9, 10, 12, and 13 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(I)(a)). A person of ordinary skill in the art would have been motivated to include a resveratrol/cyclodextrin complex in the method of McAllister because Souto teaches that complexing resveratrol with cyclodextrin increases the solubility of resveratrol, which enables higher concentrations of the antioxidant compound to be included in compositions (abstract). In the instant case, all the claimed elements (e.g., astaxanthin, resveratrol, collagen, hyaluronic acid, mixing, vacuuming, demolding) were known in the prior art (e.g., methods of making microneedle patches) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a cosmetic microneedle patch) to one of ordinary skill in the art.
Souto’s teaching to dissolve cyclodextrin in water (20 – 60 mM), then mix in a solution resveratrol in ethanol (20 to 80 mM), followed by mixing, drying, and filtering (paragraph 0048) reads on instant claim 9. A person of ordinary skill in the art would then use this resveratrol/cyclodextrin complex (as taught by Souto) in the place of resveratrol as an active ingredient (in the method of McAllister).
McAllister’s teaching to include astaxanthin, resveratrol, collagen, and hyaluronic acid in a microneedle patch (column 11 line 58, column 12 line 11, column 13 lines 14 and 16) by mixing the aforementioned substances into solution with water (column 19 lines 37 – 45, 60), then transferring the solution to a mold, applying vacuum to the mold, then removing the microneedles from the mold (column 26 lines 12 – 20, column 29 line 58 to column 30 line 3, lines 15 – 26) reads on instant claim 9.
Souto’s teaching of 20 – 80 mM resveratrol and 20 – 60 mM cyclodextrin (paragraph 0048) overlaps on the instantly claimed mass ratio of 0.8 – 1.2 parts resveratrol to 9 – 12 parts cyclodextrin as recited in claim 10. Converting Souto’s molarity concentrations to mass with a resveratrol molecular weight of 228.25 g/mol and hydroxypropyl-beta-cyclodextrin molecular weight of 1,460 g/mol results in ranges of 4.57 – 18.3 g resveratrol and 29.2 – 87.6 g hydroxypropyl-beta-cyclodextrin. As an example, 4.57 g resveratrol and 45.7 g hydroxypropyl-beta-cyclodextrin (i.e. a ratio of 1:10) falls within the claimed ratio of 0.8 – 1.2 parts resveratrol to 9 – 12 parts cyclodextrin. Claimed ranges that overlap with teachings of the prior art are prima facie obvious according to MPEP 2144.05(I).
McAllister’s teaching that the microneedle patch has a thickness less than 0.5 cm or 5,000 µm (column 31 lines 5 – 8), that the microneedles can have a length between 50 µm and 2 mm and a width at the base of 20 to 1,000 µm (column 7 lines 46 – 49, column 8 lines 23 – 24) reads on instant claim 12. Patch thickness of less than 5,000 µm overlaps on the claimed range of 200 to 500 µm, microneedle length of 50 µm to 2 mm overlaps on the claimed range of 30 to 350 µm, and based width of 20 to 1,000 µm overlaps on the claimed range of 100 to 400 µm.
McAllister’s teaching that the microneedles are conical (column 32 line19) reads on instant claim 13.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister (as cited above) in view of Souto (as cited above) and further in view Liu (as cited above).
The combined teachings of McAllister and Souto for preparing a microneedle patch wherein one component is hydrophilically modified resveratrol are discussed above.
McAllister and Souto do not teach the relative amounts of astaxanthin, resveratrol, collagen, and hyaluronic acid.
Liu teaches the missing element of the combination of McAllister and Souto.
Liu teaches that the microneedles may comprise water-soluble polymer hyaluronic acid in the amount of 50% by weight or more and cosmetic active ingredients in an amount of 0.01 to 10% (paragraphs 0064 – 0067, 0072, 0111).
A person of ordinary skill in the art would be motivated to modify the methods of McAllister and Souto to create a microneedle patch with the teachings of Liu because Liu teaches that greater than 50% water-soluble polymer hyaluronic acid is desirable so that the microneedles dissolve and that 0.01 to 10% cosmetic active ingredients provides anti-aging effects ((paragraphs 0064 – 0067, 0072, 0109 – 0111). The combination of McAllister, Souto, and Liu’s teachings is prima facie obvious as combining known elements according to known methods to yield predictable results (MPEP 2143(I)(a)).
Liu’s teaching for hyaluronic acid in the amount of 50% by weight or more (paragraphs 0064 – 0067, 0072) overlaps on the instantly claimed 70 – 97 parts hyaluronic acid as recited in claim 11. Further, Liu’s teaching for cosmetic active ingredients in an amount of 0.01 to 10% overlaps on the instantly claimed amounts for astaxanthin (0.05 – 0.3 parts) , resveratrol (0.1 – 0.3 parts), and collagen (1.5 – 4 parts) recited in claim 11. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(I).
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612