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 of Group I, claims 23-26 and 32-42, in the reply filed on 10/31/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 27-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 25, 26, 33-36, 38, 41 42 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.
Regarding claims 25, 26, 33-35, 38 and 41, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112 – Improper Dependent Form
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 37-40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 37 simply recites “A product, comprising the composition according to claim 32” and does not recited any additional limitations. The claim is not further limiting because “a product” does not impose any additional limitations to the composition as recited in instant claim 32. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101 and 35 USC § 112(a)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35, 36, 41 and 42 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a credible asserted utility or a well-established utility.
Claims 35, 36, 41 and 42 are not supported by a credible asserted utility or well-established utility because the claim(s) is/are a “use” claim. Use claims recite a use but fail to recite steps, and they do not claim a process machine, manufacture or composition. Use claims do not have utility because one of ordinary skill in the art would not appreciate the scope of the claim or the steps required to achieve the use disclosed by the claim. Therefore, the inventions of claims 35, 37, 41 and 42 are not supported by either a credible asserted utility or a well-established utility and do not comply with 35 USC § 101.
Claims 35, 36, 41 and 42 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
For the purpose of applying prior art, claims 35, 36, 41 and 42 will be interpreted as product claims.
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.
1) Claims 23, 32, 35, 37, 39, 41 and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hauxi et al. (CN 106176286 A, publication date 12/07/2016; citing copy provided by applicant for IDS filed 5/11/2023).
Hauxi relates to a skin care film [title]. Hauxi discloses a composition comprising hyaluronic acid, acetylated hyaluronic acid and hydrolyzed hyaluronic acid [p. 13, para. 7 (middle of page)] and further comprising an active agent other than hyaluronic acid [p. 14 2nd full para.].
The prior art anticipates instant claims 23, 32, 37, 39, 41 and 42 insofar as it discloses a composition (i.e., product) comprising hyaluronic acid, acetylated hyaluronic acid and hydrolyzed hyaluronic acid, and active agent, wherein the product is a skin care product. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. improving absorption of an active ingredient (i.e., instant claim 35).
2) Claim(s) 23, 32, 35, 37, and 39-42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peng et al. (CN 106109296 A, publication date 11/16/2016; citing copy provided by applicant for IDS filed 5/11/2023).
Peng discloses moisturizing essence water which comprises sodium hyaluronate, sodium acetylated hyaluronate, hydrolyzed hyaluronic acid and a skin effect agent (i.e., active agent) [p. 15, para. 3].
The prior art anticipates instant claims 23, 32, 37, 39, 41 and 42 insofar as it discloses an “essence water” moisturizer (i.e., product according to instant claim 40) comprising a salt of hyaluronic acid, a salt of acetylated hyaluronic acid, hydrolyzed hyaluronic acid, and an active agent, wherein the product is a skin care product. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. improving absorption of an active ingredient (i.e., instant claim 35).
3) Claim(s) 23, 35, 41 and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hun (KR 20190130245 A, publication date 11/22/2019; cited in IDS 5/11/2023; citing English machine translation provided by Examiner).
Hun relates to “[t]riple hyaluronic acid and cosmetic composition comprising the same” [title]. Hun discloses the “[t]riple hyaluronic acid according to the present invention is sodium hyaluronate, sodium acetylated hyaluronate, hydrolyzed hyaluronic acid, 1,2-hexanediol (1,2-Hexanediol) and purified water” [abstract].
The prior art anticipates instant claims 23, 41 and 42 insofar as it discloses a cosmetic composition (i.e., product) comprising sodium hyaluronate, sodium acetylated hyaluronate, hydrolyzed hyaluronic, wherein the product is a skin care product. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. improving absorption of an active ingredient (i.e., instant claim 35).
4) Claim(s) 23, 32, 33, 35-37, 39, 41 and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (CN 109730953 A, publication date 05/10/2019; citing copy provided by applicant for IDS filed 5/11/2023).
Liu relates to skin care [p. 8, para. 3 (Summary of the Invention)]. Liu discloses a composition comprising hyaluronic acid, hydrolyzed hyaluronic acid, acetylated hyaluronic acid and aloe vera (i.e., water soluble active agent) [p. 8, second half].
The prior art anticipates instant claims 23, 32, 33, 36, 37, 39, 41 and 42 insofar as it discloses a composition (i.e., product) comprising a salt of hyaluronic acid, acetylated hyaluronic acid, hydrolyzed hyaluronic acid, and a water soluble active agent, wherein the product is a skin care product. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. improving absorption of an active ingredient (i.e., instant claim 35).
5) Claim(s) 23, 32, 33, and 35-42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP’259 (JP 2019-11259 A, publication date 01/24/2019; citing copy provided by applicant for IDS filed 08/09/2024).
JP’259 discloses a lotion comprising 0.05% ethylbisiminomethyl guaiacol manganese chloride (i.e., oil soluble active agent according to instant claims 33 and 36), 0.2% hyaluronic acid Na (sodium hyaluronate), 0.2% hydrolyzed sodium hyaluronate, and 0.2% sodium hyaluronate [p. 7, example 3].
The prior art anticipates instant claims 23, 32, 33, 36, 37, and 39-42 insofar as it discloses a lotion (i.e., skin care product according to instant claim 40) comprising a salt of hyaluronic acid, a salt of acetylated hyaluronic acid, hydrolyzed hyaluronic acid, and ethylbisiminomethyl guaiacol manganese chloride as an active agent, wherein the product is a skin care product. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. improving absorption of an active ingredient (i.e., instant claim 35). The instant claims anticipate
With respect to instant claim 38, the composition disclosed therein reads on a composition comprising 0.02%-1.2% (i.e., 0.1-2% of 20-60%) hyaluronic acid or a salt thereof, 0.01%-1% acetylated hyaluronic acid or a salt thereof and 0.03%-1.4% hydrolyzed hyaluronic acid. The prior art amounts fall within these ranges and therefore the prior art anticipates instant claim 38.
6) Claim(s) 23, 35, 41 and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Su et al. (CN 109223670 A, publication date 01/18/2019; citing English machine translation provided by Examiner).
Su discloses a “moisture-keeping compositions, include Sodium Hyaluronate cross-linked polymer, Sodium Hyaluronate, acetylation Sodium Hyaluronate and hydrolysis Sodium Hyaluronate” [abstract].
The prior art anticipates instant claims 23, 41 and 42 insofar as it discloses a moisturizer (i.e., product) comprising a salt of hyaluronic acid, a salt of acetylated hyaluronic acid, and hydrolyzed salt of hyaluronic acid, wherein the product is a skin care product. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. improving absorption of an active ingredient (i.e., instant claim 35).
7) Claim(s) 23, 32, 35, 37, 39, 41 and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu et al. (CN 109223618 A, publication date 01/18/2019; citing English machine translation provided by Examiner).
Hu discloses “a hyaluronic acid essence, comprising the following components by weight: sodium hyaluronate 0.01%-3.0%, hydrolyzed sodium hyaluronate 0.01%-1.0%, and acetylated sodium hyaluronate 0.01%- 1.0%, sodium hyaluronate cross-linked polymer 0.1%-10%, moisturizing agent 0.1%-15.0%, soothing and repairing agent 0.1%-5%” [abstract].
The prior art anticipates instant claims 23, 32, 37, 39, 41 and 42 insofar as it discloses a composition for soothing skin (i.e., skin care product) comprising a salt of hyaluronic acid, a salt of acetylated hyaluronic acid, a salt of hydrolyzed hyaluronic acid, and an active agent (soothing and repair agent), wherein the product is a skin care product. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. improving absorption of an active ingredient (i.e., instant claim 35). The instant claims anticipate
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.
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.
1) Claim 25, 33, 34, 40 is rejected under 35 U.S.C. 103 as being unpatentable over Hauxi et al. (CN 106176286 A, publication date 12/07/2016; citing copy provided by applicant for IDS filed 5/11/2023) as applied to claims 23, 32, 35, 37, 39, 41 and 42 above.
Hauxi, which is taught above, does not anticipate instant claim 25 because it does not disclose amounts of the hyaluronic acid compounds that are entirely within the instantly claimed ranges. Hauxi does not anticipate instant claim 33, 34 and 40 because it does not explicitly disclose: the claimed active ingredient to hyaluronic acid compounds weight ratio, a water soluble or oil soluble active agent, and a mask.
Regarding instant claim 25, Hauxi discloses the composition may comprise 15-30% w/w hyaluronic acid or a salt thereof, 15-30% w/w acetylated hyaluronic acid or a salt thereof and 15-30% w/w hydrolyzed hyaluronic acid or a salt thereof [p. 13, para. 5 (2/3 down page)].
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 of the hyaluronic acid compounds (e.g., each of which encompasses 30%) overlap with the ranges of the prior art (e.g., each of which encompasses 30%). Accordingly, a prima facie case of obviousness exists for each range.
Regarding instant claim 33, Hauxi discloses the composition may comprise an active ingredient other than the hyaluronic acid [p. 14, 2nd full para.]. Hauxi also discloses the composition is prepared by dissolving the hyaluronic acid compounds in water [p. 16, para. 1]. One of ordinary skill in the art would have understood that a water soluble active ingredient would have dissolved into solution with the hyaluronic acid compounds. Accordingly one of ordinary skill in the art would have understood that a water soluble active ingredient would have been acceptable. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition disclosed by Hauxi to comprise a water soluble active ingredient.
Regarding instant claim 34, Hauxi discloses the composition may comprise 15-30% w/w hyaluronic acid or a salt thereof, 15-30% w/w acetylated hyaluronic acid or a salt thereof and 15-30% w/w hydrolyzed hyaluronic acid or a salt thereof [p. 13, para. 5 (2/3 down page)]. Hauxi also discloses the composition may comprise an active ingredient in amounts from 0-20% w/w [p. 14, 2nd full para.].
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 range for the ratio of active ingredient to hyaluronic acid compounds overlaps with the same range of the prior art. For example, according to Hauxi the composition may comprise 15% w/w hyaluronic acid or a salt thereof, 15% w/w acetylated hyaluronic acid or a salt thereof, 15% w/w hydrolyzed hyaluronic acid or a salt thereof and 15% w/w active ingredient. In this case, the mass ratio of active ingredient to hyaluronic acid compounds would be 15:45, or 1:3, which overlaps with the instantly claimed range of (1-5):(1-5). Accordingly, a prima facie case of obviousness exists for the ratio of instant claim 34.
Regarding instant claim 40, Hauxi discloses the composition, used as a film, “can be cut into different shapes doe different part the face and body, such as the whole part” (i.e., whole face covering; mask) [p. 14, para. 8, line 2]. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition of Hauxi as mask because Hauxi suggests doing so.
2) Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hun (KR 20190130245 A, publication date 11/22/2019; cited in IDS 5/11/2023; citing English machine translation provided by Examiner) as applied to claims 23, 35, 41 and 42 above, and further in view of Hapman (Hapman.com, 08/13/2018 [retrieved 01/06/2025], https://web.archive.org/web/20180813024908/http://hapman.com/white-paper-pre-mix-solutions-and-slurries-effectively-economically-and-safely/).
Hun, which is taught above, does not anticipated instant claim 24 because it does not disclose a composition consisting of hyaluronic acid or a salt thereof, an acetylated hyaluronic acid or a salt thereof, and a hydrolyzed hyaluronic acid or a salt thereof. Hun does disclose the composition is prepared by adding the sodium hyaluronate, sodium acetylated hyaluronate, and hydrolyzed hyaluronic acid to water and to be dissolved before mixing in 1,2-hexandiol [p. 12, para. 4-5].
Hapman discloses “[t] he most common method for combining powders and liquids is to introduce the powder into an agitated tank that has been filled with the liquid component” and that “[t]he disadvantages of this method are that it produces substantial dusting, creates inefficient liquid-to-solids contact and is labor intensive” [p. 2, para. 1]. Hapman discloses that a solution to these issues is to employ a method of mixing with “a wetting cone and an eductor working in combination with a powder feeder” [p. 2, last para.]. According to Hapman “[t]he eductor uses the flow of liquid through an orifice to create a vacuum through a calculated pressure drop. The vacuum then draws the powder and wetting solution through the eductor” [p. 2, last para.].
First, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have applied the methods disclosed in Hapman to prepare a pre-mix slurry of the composition disclosed by Hun. One would have been motivated to use the methods of Hapman because Hapman teaches the methods reduce dusting, improve liquid to solid contact and are not labor intensive. One would have had an expectation of success because the Hapman methods are intended for mixing solids with liquids, as required by Hun (i.e., mixing hyaluronic acid powders with water). See MPEP 2143, Exemplary Rationale D.
Second, in applying the methods of Hapman to the composition of Hun, a mixture of only the powdered components would have been provided for the ‘powder feeder’. Accordingly, the powder feeder would have held a composition consisting of hyaluronic acid or a salt thereof, an acetylated hyaluronic acid or a salt thereof, and a hydrolyzed hyaluronic acid or a salt thereof, i.e., the powders of Hun.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated a composition consisting of hyaluronic acid or a salt thereof, an acetylated hyaluronic acid or a salt thereof, and a hydrolyzed hyaluronic acid or a salt thereof.
3) Claims 26, 32, 34, and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hun (KR 20190130245 A, publication date 11/22/2019; cited in IDS 5/11/2023; citing English machine translation provided by Examiner) as applied to claims 23, 35, 41 and 42 above, and in further view of Hauxi et al. (CN 106176286 A, publication date 12/07/2016; citing copy provided by applicant for IDS filed 5/11/2023).
Hun, which is taught above, does not disclose a hyaluronic acid with a molecular weight within 100 to 500 KDa, an active agent and a weight ratio of active agent to hyaluronic acid compounds.
Hun discloses the sodium hyaluronate has a molecular weight of 1.5 Mda (1,500kDa), the sodium acetylated hyaluronate may be 0.03 to 0.1 Mda (30-100kDa), and the hydrolyzed hyaluronic acid may be 0.003 to 0.01 Mda (3 to 10kDa) [p. 6, para. 5]. Hun also discloses that when hyaluronic acid is delivered to the skin by this composition it provides excellent skin moisturizing [abstract, last two lines].
Hauxi, which relates to a skin care product [title], discloses a composition comprising hyaluronic acid, acetylated hyaluronic acid and hydrolyzed hyaluronic acid [p. 13, para. 7 (middle of page)]. Hauxi discloses the molecular weight of the acetylated hyaluronic acid to be between 10 and 100 kDa and the molecular weight of the hyaluronic acid to be from 200 to 1500 kDa [p. 14, first full para.]. Hauxi also discloses the composition “solves the problem of high-molecular-weight hyaluronic acid stickiness [p. 15, lines 1-2] and that the hyaluronic acid of the composition has moisturizing properties [p. 13, para. 3, lines 3-4].
Instant claim 26 recites molecular weights, for example “100k-500kDa”. The Examiner is interpreting this to be 100k to 500k Da or 100,000 Da to 500,000 Da, for example.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the higher molecular weight hyaluronic acid of Hun for the lower molecular weight hyaluronic acid of Hauxi. One would have been motivated to make this substitution to improve the skin feel (i.e., solve the problem of stickiness) as discloses by Hauxi. One would have had an expectation of success because the compositions of Hun and Hauxi are very similar. Namely, both the compositions are for skin care and comprise a combination of hyaluronic acids, acetylated hyaluronic acids and hydrolyzed hyaluronic acid of overlapping molecular weights. The skilled artisan would have been motivated to have substituted the hyaluronic acid of Huaxi in place of the hyaluronic acid of Hun for moisturizing properties with a reasonable expectation of success. The simple substitution of one known element (e.g., the hyaluronic acid of Hauxi) in place of another (e.g., the hyaluronic acid of Hun) in order to achieve predictable results (moisturizing) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Additionally, 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 of hyaluronic acid, acetylated hyaluronic acid and hydrolyzed hyaluronic acid of 100-500 kDa, 10-100 kDa and 0.8-20 kDa respectively, overlap with the ranges of the prior art, which are 200-1,500 kDa, 30-100 kDa and 3-10 kDa, respectively. Accordingly, a prima facie case of obviousness exist for each range.
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 hyaluronic acid or salt thereof, acetylated hyaluronic acid or salt thereof and hydrolyzed hyaluronic acid or salt thereof, wherein the molecular weights are within the instantly claimed ranges.
Regarding instant claim 32, 34, 37 and 39, Hun discloses “0.5 to 1.5 parts by weight of sodium hyaluronate, 0.005 to 0.015 parts by weight of sodium acetylated hyaluronate, 0.05 to 0.15 parts by weight of hydrolyzed hyaluronic acid” (i.e., 0.555-1.665% total hyaluronic acid compounds) [p. 6, para. 4]. Hun does not disclose an active agent other than hyaluronic acid.
Hauxi discloses the hyaluronic acid composition may further comprise an active ingredient other than hyaluronic acid in amounts from 0-20% [p. 14, 2nd full para.].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the active agent of Hauxi with the composition of Hun. One would have been motivated to make this combination for the clear and desirable benefit of providing a composition with additional skin care action. One would have had an expectation of success because the compositions of Hun and Hauxi are very similar. Namely, both the compositions are for skin care and comprise a combination of hyaluronic acids, acetylated hyaluronic acids and hydrolyzed hyaluronic acid of overlapping molecular weights. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, once combined, the claimed range for the ratio of active ingredient to hyaluronic acid composition (i.e., hyaluronic acid or salt thereof, acetylated hyaluronic acid or salt thereof and hydrolyzed hyaluronic acid or salt thereof) overlaps ratio range of the prior art. 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 prior art discloses a suitable amount of active ingredient is 0-20% and a suitable amount of hyaluronic acid composition (or total amount of hyaluronic acid compounds) is 0.555-1.665%. The resulting ratio range, which includes a ratio of 1:1, overlaps with the claimed range and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition (i.e., skin care product; instant claims 37 and 39) comprising hyaluronic acid or salt thereof, acetylated hyaluronic acid or salt thereof, hydrolyzed hyaluronic acid or salt thereof and an active ingredient. Wherein the ratio of active ingredient to hyaluronic acid composition is within the instantly claimed range.
Regarding instant claim 38, Hun discloses “0.5 to 1.5 parts by weight of sodium hyaluronate, 0.005 to 0.015 parts by weight of sodium acetylated hyaluronate, 0.05 to 0.15 parts by weight of hydrolyzed hyaluronic acid” [p. 6, para. 4].
The composition disclosed by instant claim 38 reads on a composition comprising 0.02%-1.2% (i.e., 0.1-2% of 20-60%) hyaluronic acid or a salt thereof, 0.01%-1% acetylated hyaluronic acid or a salt thereof and 0.03%-1.4% hydrolyzed hyaluronic acid.
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 of the hyaluronic acid compounds overlap with the same ranges of the prior art (see Table 1 below) and so a prima facie case of obviousness exists.
Table 1. Ranges of hyaluronic acid compounds according to instant claim 38 and the prior art.
Ingredient
Instant claim 38 (%)
Hun et al. (Prior Art) (%)
Hyaluronic acid or salt thereof
0.02-1.2
0.5-1.5
Acetylated hyaluronic acid or salt thereof
0.01-1
0.005-0.015
Hydrolyzed hyaluronic acid or salt thereof
0.03-1.4
0.05-0.15
Regarding instant claim 40, Hun discloses an example of the hyaluronic acid composition in the form of a lotion [p. 8, lines 5-6].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated the composition taught by Hun and Hauxi as a lotion because Hun discloses lotions are suitable formulations.
4) Claims 33 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hun (KR 20190130245 A, publication date 11/22/2019; cited in IDS 5/11/2023; citing English machine translation provided by Examiner) in view of Hauxi et al. (CN 106176286 A, publication date 12/07/2016; citing copy provided by applicant for IDS filed 5/11/2023) as applied to claim 23, 26, 32, 34, 35, and 37-42 above, and further in view of Hakozaki et al. (British Journal of Dermatology, 2002, 147, p. 20-31).
Hun and Hauxi, which are taught above, differ from the instant claims insofar as they do not teach a specific active agent.
Hauxi does discloses the composition may be used for whitening in the skin [p. 20, claim 10, lines 2-3].
Hakozaki highlights the desire for skin lightening by disclosing: “In many regions of the world, having a light and even skin colour is highly valued. Approximately 60% of Japanese women and 75% of Chinese women desire to achieve a lighter skin colour” [p. 20, col. 1, first two sentences]. Hakozaki also discloses “niacinamide significantly decreased hyperpigmentation and increased skin lightness compared with vehicle alone after 4 weeks of use” [p. 20, Summary, last sentence of Methods].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected the niacinamide as the active agent in the composition taught by Hun and Hauxi because Hakozaki discloses it is useful for whitening in the skin. One would have been motivated to select niacinamide because Hauxi desires skin whitening and Hakozaki discloses skin whitening is desired generally. One would have had an expectation of success because Hakozaki discloses niacinamide is proven to lighten skin.
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 the hyaluronic acid compounds as taught by Hun and Hauxi, and further comprising niacinamide, a water-soluble active agent.
Conclusion
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612