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 .
Applicants’ arguments, filed 04/13/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restrictions – New by Amendment
In the Restriction Requirement mailed 09/03/2025, claims 35, 41 and 42 were interpreted as being directed to a hyaluronic acid composition. Claims 35, 41 and 42 have been amended to be methods, and are therefore no longer directed to the elected invention.
Consequently, claims 35, 41, and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. 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)).
Claim Rejections - 35 USC § 103 – New by Amendment
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 23-26, 32-34, 37, 39, 34, and 43-45 are is rejected under 35 U.S.C. 103 as being unpatentable over Bach et al. (US 2005/0272695 A1, publication date 12/08/2005) 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).
Regarding instant claims 23, 25 and 26, Bach “relates to atomized products comprising hyaluronic acid or a salt thereof, which product has a high solubility in an aqueous solvent” [abstract]. The method of producing the product comprises spray-drying hyaluronic acid [p. 14, claims 21-27]. Bach suggests including “low-molecular weight fractions of hyaluronic acid, that it is capable of penetrating the skin barrier to reestablish the natural content of hyaluronic acid in the skin, therefore Such fractions are particularly suitable for cosmetic compositions Sold as anti-skin-ageing and anti-wrinkle agents” [0095]. Bach further discloses that “low MW hyaluronic acid exhibits anti-inflammatory effect and have potential applications in the treatment of inflammatory diseases. A reduction of the average molecular weight of a hyaluronic acid or salt thereof may be achieved by standard methods in the art, such as, … acid hydrolysis” [0095]. To that end, Bach discloses hyaluronic acids with molecular weights from 10,000 to 800,000 Da [p. 14, claim 24]. Bach also desires hyaluronic acids with a molecular weight of 300,000 to 3,000,000 Da [p. 14, claim 23]. In the exemplary production methods, a liquid feed of a hyaluronic acid composition is spray dried (i.e., dissolving hyaluronic acid and spray drying the resulting solution) [0144].
Bach does not disclose acetylated hyaluronic acid and the instantly claimed ranges for the amounts of the hyaluronic acids.
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)]. 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 teaches acetylated hyaluronic acid is advantageous because “[o]utside the good moisture retention energy of bright matter acid, due to the introducing of acetyl group, improve the lipotropy of hyaluronic acid, improve and skin Affinity, has more preferable soothing effect, and the acetylation hyaluronic acid of lower molecular weight is also more easy to through keratodermatitis quilt Absorb” (i.e., the acetyl groups improve skin affinity, soothing effect, skin penetration and absorption) [paragraph spanning pages 5 and 6]. Hauxi further discloses the molecular weight of the acetylated hyaluronic acid to be between 10 and 100 kDa [p. 14, first full para.].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the acetylated hyaluronic acid of Hauxi with the spray dried hyaluronic acid products of Bach. One would have been motivated to make this combination because Hauxi teaches acetylated hyaluronic acid has the desirable effects of improving skin soothing, penetration and absorption in compositions comprising hyaluronic acid and hydrolyzed hyaluronic acid. One would have had an expectation of success because Hauxi discloses acetylated hyaluronic acid may be combined with hyaluronic acid and hydrolyzed hyaluronic acid, and the molecular weights disclosed by Hauxi fall within the range of acceptable molecular weights disclosed by Bach. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, given the disclosure of each component individually (e.g., high molecular weight hyaluronic acid and low molecular weight hydrolyzed hyaluronic acid), it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Bach. MPEP 2143 and 2144.06(I).
Finally, 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 ranges of instant claims 23, 25 and 43 for the amount 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. The instantly claimed molecular weights of hyaluronic acid, acetylated hyaluronic acid and hydrolyzed hyaluronic acid also overlap with the ranges of hyaluronic acid, acetylated hyaluronic acid and low molecular weight (i.e., hydrolyzed) hyaluronic acid taught by the prior and so a prima facie case of obviousness exists for each range. See Table below.
Table 1. Molecular weight ranges
Component
Claim 26 (kDa)
Claim 44 (kDa)
Claim 45 (kDa)
Prior art (kDa)
Hyaluronic acid
100-500
150-300
210-300
300-3000
Acetylated Hyaluronic acid
10-100
10-50
20-30
10-800
Hydrolyzed Hyaluronic acid
0.8-20
3-10
3-10
10-100
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a hyaluronic composition comprising hyaluronic acid, acetylated hyaluronic acid, and hydrolyzed hyaluronic acid in the instantly claimed amounts. Wherein the composition is prepared by dissolving the hyaluronic acids to obtain a solution and spray-drying the solution to obtain the hyaluronic composition. Wherein the molecular weights are within the instantly claimed ranges.
Regarding instant claim 24, Bach does not require any additional components. In fact, in the example compositions Bach discloses spray dried compositions consisting of hyaluronic acid (see, for example, Example 1, paragraphs 144-146).
Given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Bach . MPEP 2143 and 2144.06(I). Therefore it, would have been obvious for one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a hyaluronic composition consisting of hyaluronic acid, acetylated hyaluronic acid, and hydrolyzed hyaluronic acid in the instantly claimed amounts. Wherein the composition is prepared by dissolving the hyaluronic acids to obtain a solution and spray-drying the solution to obtain the hyaluronic composition.
Regarding instant claims 32 and 33, Bach discloses the composition may comprise and active agent (i.e., instant claim 32) [0017]. Bach also discloses the composition is intended to have a high solubility in an aqueous solvent [abstract].
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, before the effective filling date of the claimed invention, to have selected a water soluble active ingredient because Bach desires a composition that has a high solubility in an aqueous solvent. Therefore, 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 Bach and Hauxi to comprise a water soluble active ingredient.
Regarding instant claim 34, Hauxi discloses the combination of hyaluronic acids 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 suggests the active ingredient may be present 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 37, Bach discloses the compositions may comprise excipients (i.e., auxiliary ingredients) [0121].
Regarding instant claim 39, Bach discloses that medical treatments may be performed with the composition (i.e., product is a medicine) [0131].
2) Claims 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bach et al. (US 2005/0272695 A1, publication date 12/08/2005) 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 claims 23-26, 32-34, 37, 39, 34, and 43-45 above, and further in view of Marie (Humblebee & Me, 05/14/2018 [retrieved 05/27/2026], https://www.humblebeeandme.com/lets-talk-about-hyaluronic-acid/).
Bach and Hauxi, which are taught above, differ from the instant claims insofar as they do not teach a product comprising 0.1-2% of the hyaluronic acid composition and a specific form of the composition. Bach does teach the compositions may comprise excipients (i.e., auxiliary ingredients) [0121] and that medical treatments may be performed with the composition (i.e., product is a medicine) [0131]. Furthermore, Bach teaches that compositions comprising a low molecular weight hyaluronic acid fraction are advantageous because they “are particularly suitable for cosmetic compositions sold as anti-skin-ageing and anti-wrinkle agents” [0095].
Hauxi teaches acetylated hyaluronic acid is advantageous because “[o]utside the good moisture retention energy of bright matter acid, due to the introducing of acetyl group, improve the lipotropy of hyaluronic acid, improve and skin Affinity, has more preferable soothing effect, and the acetylation hyaluronic acid of lower molecular weight is also more easy to through keratodermatitis quilt Absorb” (i.e., the acetyl groups improve skin affinity, soothing effect, skin penetration and absorption) [paragraph spanning pages 5 and 6].
Marie relates to using hyaluronic acid in cosmetic compositions and discloses hyaluronic acid “stars in many hydration and anti-aging formulas, lauded for its ability to plump and hydrate skin, reducing the appearance of fine lines and generally leaving skin looking healthier and happier” [p. 1, para. 1]. Marie teaches making a 1% hyaluronic acid composition and suggests using the composition as a hydrating toner [pages 11-12].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the method of making a toner disclosed by Marie and the hyaluronic acid composition taught by Bach and Hauxi. One would have been motivated to do so because Bach teaches cosmetic compositions comprising a low molecular weight (hydrolyzed) hyaluronic acid fraction and Hauxi discloses acetylated hyaluronic acid improves skin soothing, penetration and absorption. On would have been motivated to make a 1% solution because Marie discloses that is a suitable concentration for hyaluronic acid in cosmetic compositions. One would have had an expectation of success because Bach teaches cosmetic compositions. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, in making this combination, the instantly claimed range for cumulative hyaluronic (0.1-2%) would have overlapped with the amount taught by the prior art (1%). Accordingly a prima facie case of obviousness exists because 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).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a product comprising a water soluble active ingredient, auxiliary ingredients and a combination of hyaluronic acid, hydrolyzed hyaluronic acid, and acetylated hyaluronic acid, as taught by Bach and Hauxi and discussed above. Wherein the combination of hyaluronic acids is present within the instantly claimed range. Wherein the product is a toner for skin care.
3) Claims 46 is rejected under 35 U.S.C. 103 as being unpatentable over Bach et al. (US 2005/0272695 A1, publication date 12/08/2005) 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 claims 23-26, 32-34, 37, 39, 34, and 43-45 above, and further in view of Murata et al. (WO 2008004530 A1, publication date 01/10/2008; citing machine English translation).
Bach and Hauxi, which are taught above, differ from the instant claims insofar as they do not teach the claimed concentration of the hyaluronic acid solution for spray drying.
Murata discloses “method for producing a powder of hyaluronic acid or a salt thereof containing no organic solvent, which is characterized by spray drying an aqueous solution containing hyaluronic acid or a salt thereof” [abstract]. For the spray drying process Murata discloses “the concentration of hyaluronic acid or its salt in the aqueous solution to around 4% (w / v), the spray nozzle is a two-fluid nozzle, the blowing temperature is 130-180 ° C at the inlet temperature, the outlet temperature Can be obtained by spray-drying under conditions of 70 to 100 ° C. and a feed flow rate of 0.8 to 1.2 kg / h” [page 8, paragraph 22].
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, before the effective filling date of the claimed invention, to have selected a 4% solution of hyaluronic acid to be spray dried because Murata discloses a 4% solution of hyaluronic acid is suitable to be spray dried.
4) Claims 47 is rejected under 35 U.S.C. 103 as being unpatentable over Bach et al. (US 2005/0272695 A1, publication date 12/08/2005) 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 claims 23-26, 32-34, 37, 39, 34, and 43-45 above, and further in view of Kent et al. (Powder and Bulk Solids, 02/21/2007 [retrieved 05/27/2026], https://www.powderbulksolids.com/drying/spray-dryer-optimization).
Bach and Hauxi, which are taught above, differ from the instant claims insofar as they do not teach a feeding temperature of 120-150 deg. C. Bach does, however, disclose the following parameters for spray drying at paragraph 129:
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Kent relates to optimizing spray drying [tittle]. According to Kent “[f]eed temperature, particularly in existing plants, can also be optimized. Theoretically, heating feed as close to the dryer’s inlet temperature as possible is ideal” [p. 3, last paragraph].
"[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)).
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the parameters of Bach to increase the feed temperature to as close to inlet temperature as possible through routine optimization because Kent discloses it is ideal for spray drying. One would have had an expectation of success because Kent discloses feed temperature of spray drying can also be optimized.
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 instantly claimed the range for discharge temperature (90-100 deg. C) overlaps with the range of the prior art (40-90 deg. C) and so a prima facie case of obviousness exists
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have spray dried to the hyaluronic acid composition as taught by Bach and Hauxi, and discussed above, with feeding temperatures and discharge temperatures of the spray-drying within the instantly claimed ranges.
Response to Arguments
1) On page 9 of their Remarks, Applicant argues the presently required spray-drying method imparts unexpectedly superior results to the claimed invention over the mixing of Hauxi.
This argument is moot in view of the new rejections necessitated by amendment. However, the examiner would like to note that overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy requirements any of these view of the new rejections necessitated by amendment.
(i) The closest prior art is Example 2 of Bach at paragraphs 147-153:
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512
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(ii) The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (MPEP 716.02(b)). In the present case, improved penetration and absorption would have been expected with the addition of hydrolyzed hyaluronic acid and acetylated hyaluronic acid to the spray dried hyaluronic acid compositions of Bach. See, for example, paragraph 95 of Bach which discloses low molecular weight hyaluronic acid, such as hydrolyzed hyaluronic acid, increases bioavailability because it is capable of penetrating the skin. Additionally, Hauxi teaches acetylated hyaluronic acid is advantageous because “[o]utside the good moisture retention energy of bright matter acid, due to the introducing of acetyl group, improve the lipotropy of hyaluronic acid, improve and skin Affinity, has more preferable soothing effect, and the acetylation hyaluronic acid of lower molecular weight is also more easy to through keratodermatitis quilt Absorb” (i.e., the acetyl groups improve skin affinity, soothing effect, skin penetration and absorption) [paragraph spanning pages 5 and 6]. Therefore, a skilled artisan would have reasonably expected that both hydrolyzed and acetylated hyaluronic acid would have enhanced skin penetration.
Finally, Bach discloses “[t]he present invention shows that a spray-dried HA
product greatly improves the Solubility of the product” [0015].
(ii) The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). In the present case, the claims do not appear to be commensurate in scope with the showing of unexpected results because the independent claim does not recite molecular weights and spray drying parameters, e.g., atomizer frequency, feed temperature, and discharge temperature. The specific molecular weights disclosed in the evidence provided by applicant would not have been expected to reasonably represent all molecular weights, as instantly claimed, because the molecular weight of hyaluronic acid is known to affect skin penetration (see Bach at paragraph [0095]). Additionally, inlet and outlet temperatures of spray drying effect the physical and chemical properties of the resultant powders, as evidenced by Hywell (Hywell, 04/07/2024 [retrieved 05/27/2026], https://www.hywellco.com/Spray-Drying-Technology-And-Influencing-Factors-id43465686.html) at page 2 paragraph 1. Therefore, the broadly claimed spray-drying of the independent claim is not commensurate in scope with the evidence which discloses spray drying with a feed temperature between 120 and 150 deg. C, discharge temperature between 80 and 100 deg. C and atomizer frequencies, which is absent from the claims entirely.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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