FINAL 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 06/07/2026 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 07/09/2026 in which claims 2 and 3 were canceled; claims 5-9 were withdrawn; and claims 1 and 4 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 1, 4, and 10-12 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained Objection
Drawings
The drawings filed 05/17/2024 remain objected to because the descriptions of the Drawings provided on page 4 of the specification do not accurately describe the Drawings of FIG(s) 1-4. For example, the specification described FIG.1 as “a photograph of an ultra-small-sized molecular hyaluronic acid film.” However, FIG. 1 in the Drawings depicts three (3) photographs of films having different molecular weights.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification in compliance with 37 CFR 1.121(b) to provide accurate descriptions of FIG(s) 1-4 (without adding new matter), are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant's arguments filed 07/09/02026 have been fully considered but they are not persuasive.
Applicant argues that “paragraphs [0025]-[0028] of the specification have been amended to accurately describe the content of FIGs. 1-4, without addition of new matter.” (Remarks, page 5, 2nd and 3rd paragraphs).
In response, the Examiner disagrees. the amendments to the specification filed 07/09/2026 introduced new matter and thus, was not entered for the reason set forth below.
Accordingly, the objection to the Drawings is maintained for the reason of record.
New Objection
Specification
The amendment filed 07/09/02026 is objected to under 35 U.S.C. 132(a) because the amendment introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is/are not supported by the original disclosure is/are as follows:
“after microbial culture” in paragraph [27]
“cracks generated during film drying” in paragraph [28]
Applicant is required to cancel the new matter in the reply to this Office Action.
Accordingly, the amendments to the specification filed 07/09/02026 are NOT entered.
Maintained-Modified Rejections
Modification Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112
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.
Claim 4 is 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.
The limitation of “the hyaluronic acid is selected from the group consisting of the hyaluronic acid …” as recited in claim 4 is not further limiting from claim 1 because the hyaluronic acid is selected from the hyaluronic acid is redundant, as well as, hyaluronic acid is already present in claim 1 and thus, the limitation of “the hyaluronic acid is selected from the group consisting of the hyaluronic acid …” from claim 4 is not structurally limiting from claim 1.
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.
Response to Arguments
Applicant's arguments filed 07/09/02026 have been fully considered but they are not persuasive.
Applicant argues that the amendments to claim 4 have addressed the rejection under 35 U.S.C. §112(d). (Remarks, bottom of page 4).
In response, the Examiner disagrees. Applicant’s amendments to claim 4 did not obviate the rejection under 35 U.S.C. §112(d) because the issue remains the same in light of the amendments for the reasons discussed in the standing 112(d) rejection above. See page 5 of this office action, said page being incorporated herein in its entirety.
Accordingly, the rejection of claim 4 under 35 U.S.C. §112(d) is maintained for the reason of record.
Modified Rejection
Necessitated by Applicant’s Claim Amendments
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 nonobviousness.
Claim(s) 1, 4, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kweon et al (US 2020/0016795 A1) in view of Wang et al (EP 3991716A1; filing date: 20 December 2019; hereafter as “Wang ‘716”) and Wang et al (WO 2022/100519 A1; filing date: 11/5/2021; citation and English translation via US 2024/0009107 A1; hereafter as “Wang ‘519”).
Regarding claims 1 and 4, Kweon teaches a film comprising a hyaluronate (hyaluronic acid) (Abstract; [0001], [0011]-[0018], [0032], [0040], [0041], [0044]-[0045], [0053], [0055]; Example 1; claims 1-12). Kweon teaches the film has a thickness of 0.025 mm to 5 mm ([0026], [0032], [0040]; claim 10), particularly, a film thickness of 0.1 mm or 1 mm ([0092], [0100], and [0103]).
While Kweon does not teach the hyaluronic acid as being a mixture of 84.0% to 98.5% by weight of the first hyaluronic acid having a molecular weight in a range of 2,000 to 1x104 Da and 1.5% to 16% by weight of the second hyaluronic acid having a molecular weight in a range of 1x105 to 1x106 Da, it would have been obvious to include said first hyaluronic acid and said second hyaluronic acid as the hyaluronic acid in the film of Kweon in view of the guidance from Wang ‘716.
Wang ‘716 teaches a hyaluronic acid composition comprising hyaluronic acids or salts of two or more molecular weights thereof, wherein at least one of the hyaluronic acids or salts thereof has a molecular weight between 1.6 kDA and 500 kDA (low molecular weight (LMW) hyaluronic acid), and at least one of the hyaluronic acid has a molecular weight between 800 kDA and 3,000 kDA (high molecular weight (HMW) hyaluronic acid), and wherein the HMW hyaluronic acid is present in the composition in an amount from 4.3% w/w to 9% w/w and the LMW hyaluronic acid is present in the composition in an amount from 81.8% w/w to 86.9% w/w (Abstract; [0001], [0005], [0010]-[0037], [0070]-[0083]; claims 1-25). Wang ‘716 teaches the hyaluronic acid composition having different molecular weights of hyaluronic acid provides multiple skin protection effects of moisturizing, softening stratum corneum, repairing and nourishing basal skin, and has a strong anti-oxidation ability ([0032]-[0037]; claim 25).
It would have been obvious to one of ordinary skill in the art to include the hyaluronic acids having two different molecular weights of Wang ‘716 as the hyaluronic acid in the film of Kweon, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Wang ‘716 provided the guidance for using hyaluronic acids or salts of two or more molecular weights thereof, wherein at least one of the hyaluronic acids or salts thereof has a molecular weight between 1.6 kDA and 500 kDA (low molecular weight (LMW) hyaluronic acid), and at least one of the hyaluronic acid has a molecular weight between 800 kDA and 3,000 kDA (high molecular weight (HMW) hyaluronic acid), and wherein the HMW hyaluronic acid is present in the composition in an amount from 4.3% w/w to 9% w/w and the LMW hyaluronic acid is present in the composition in an amount from 81.8% w/w to 86.9% w/w. As discussed above, Wang ‘716 indicated such use of different molecular weights of hyaluronic acid provides multiple skin protection effects of moisturizing, softening stratum corneum, repairing and nourishing basal skin, and has a strong anti-oxidation ability (Wang ‘716: [0032]-[0037]; claim 25). One of ordinary skill in the art would have reasonable expectation of success in include the hyaluronic acids having two different molecular weights of Wang ‘716 as the hyaluronic acid in the film because Kweon indicated that suitable hyaluronate to be used in the film include hyaluronate having a molecular weight of 0.1 to 2.5 MDa (Kweon: [0032]), which encompassed the hyaluronic acids of Wang ‘716. Furthermore, Kweon indicated the hyaluronic acid film is suitable for incorporating in cosmetic products such as mask packs (Kweon: Abstract; [0001], [0011]-[0018], [0032], [0040], [0041], [0044]-[0045], [0053], [0055]; Example 1; claims 1-12). Thus, an ordinary artisan provided the guidance form Wang ‘716 would have looked to including the hyaluronic acids having two different molecular weights of Wang ‘716 as the hyaluronic acid in the film of Kweon so as to provide a hyaluronic acid film that is suitable for use in cosmetic products that provides multiple skin protection effects of moisturizing, softening stratum corneum, repairing and nourishing basal skin, and has a strong anti-oxidation ability, and achieve Applicant’s claimed invention with reasonable expectation of success.
Furthermore, it is noted that the hyaluronic acids or salts of two or more molecular weights thereof, wherein at least one of the hyaluronic acids or salts thereof has a molecular weight between 1.6 kDA and 500 kDA (low molecular weight (LMW) hyaluronic acid), and at least one of the hyaluronic acid has a molecular weight between 800 kDA and 3,000 kDA (high molecular weight (HMW) hyaluronic acid), and wherein the HMW hyaluronic acid is present in the composition in an amount from 4.3% w/w to 9% w/w and the LMW hyaluronic acid is present in the composition in an amount from 81.8% w/w to 86.9% w/w, as taught by Wang ‘716 overlaps the claimed “the hyaluronic acid comprises 84% to 98.5% by weight of hyaluronic acid having a molecular weight in a range of 2,000 to 1x104 Da and 1.5% to 16% by weight of hyaluronic acid having a molecular weight in a range of 1x105 to 1x106 Da.” Thus, it is noted that the Courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the molecular weights of hyaluronic acids, as well as, the weight amounts of said hyaluronic acids so as to achieve a desired hyaluronic acid film would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Since the structural limitations of the film as recited in claim 1 have been rendered obvious by Kweon in view of Wang ‘716, the claimed property of “a transdermal absorption rate in the range of 72% to 93%” as recited in claim 1 would have been construed as an implicit property of the film comprising the mixture of hyaluronic acids of Kweon in view of Wang ‘716. It is reasonably obvious that the “transdermal absorption rate in a range of 72% to 95%” would have been an implicit property of the film containing the mixture of hyaluronic acids of Kweon in view of Wang ‘716 because Wang ‘519 established that a hyaluronic acid composition containing a hyaluronic acid of Kweon and Wang ‘716 has significantly improved transdermal absorption rate (Wang ‘519: Abstract; [0008]-[0049], [0119]; claims 1-42). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Furthermore, "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 10, Kweon teaches a cosmetic mask pack containing the hyaluronic acid film (Abstract; [0001], [0011]-[0018], [0032], [0040], [0041], [0044]-[0045], [0053], [0055]; Example 1; claims 1-12).
Regarding claim 11, Kweon teaches hyaluronate (hyaluronic acid) is known to be suitable for use in food products ([0004) and thus, it would have been obvious to one of ordinary skill in the art to provide an edible film containing the hyaluronic acid film.
Regarding claim 12, Kweon teaches a patch for medical device comprising the hyaluronic acid film (Abstract; [0001], [0011]-[0018], [0032], [0040], [0041], [0044]-[0045], [0053], [0055]; Example 1; claims 1-12).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 07/09/02026 have been fully considered but they are not persuasive.
Applicant argues that Kweon teaches away from the claimed ultra-small-sized molecular hyaluronic acid film. (Remarks, page 7 to page 8).
In response, the Examiner disagrees. Kweon establishes at paragraphs [0045] and [0059] that when a low molecular weight is used, the low molecular weight would need to be dissolved a high concentration (e.g., a concentration of 5% or more) to achieve a desired viscosity to form a film. This is in line with Applicant’s claimed invention in which the low molecular weight hyaluronic acid (“first hyaluronic acid”) is used at high concentration of 84.0% to 98.5% by weight. Thus, Kweon does not teach away, but rather teach towards Applicant’s claimed invention by also teaching that the film thickness was particularly 0.1 mm or 1 mm (Kweon: [0092], [0100], and [0103]), which meets claimed “the film has a thickness in a range of 0.01 to 1.5 mm.”
Applicant argues that Wang ‘519 is directed to a fundamentally different physical form and thus, no motivation to combine Wang ‘519 with Kweon. (Remarks, page 8).
In response, the Examiner disagrees. While Kweon is in a film form, the film is made from a hyaluronic acid composition, just as Wang ‘519 is a hyaluronic acid composition. Wang ‘519 was used to establish that hyaluronic acid composition is recognized in the prior art to have significantly improve transdermal absorption rate.
Thus, as discussed in the standing 103 rejection, it is maintained that it would have been reasonably obvious that the “transdermal absorption rate in a range of 72% to 95%” would have been an implicit property of the film containing the mixture of hyaluronic acids of Kweon in view of Wang ‘716 because Wang ‘519 established that a hyaluronic acid composition containing a hyaluronic acid of Kweon and Wang ‘716 has significantly improved transdermal absorption rate (Wang ‘519: Abstract; [0008]-[0049], [0119]; claims 1-42). Thus, it is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Furthermore, "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Applicant has not shown by objective evidence to the contrary.
Applicant argues that “Wang ‘716 assigns opposite roles to the low- and high-molecular weight components,” and thus, Applicant alleges that amended claim 1 is “directly opposite to the formulation concept of Wang '716, which employs the high-molecular-weight polymer, advantageous for forming a moisturizing film, as the principal component.” (Remarks, page 8, last paragraph to page 9).
In response, the Examiner disagrees. As discussed in the pending 103 rejection and particularly at paragraph [0070] of Wang ‘716, the high molecular weight (HMW) hyaluronic acid is present in the composition in an amount from 4.3% w/w to 9% w/w and the low molecular weight (LMW) hyaluronic acid is present in the composition in an amount from 81.8% w/w to 86.9% w/w. See at least Compositions 4 and 5 of the Table from paragraph [0070] of Wang ‘716. Thus, the teachings from Wang ‘716 is not in direct opposite as claimed invention, but rather, the teachings from Wang ‘716 teaches towards Applicant’s claimed invention. As such, Wang ‘716 is properly combined with Kweon to render obvious Applicant’s claimed invention.
Applicant argues “[t]he claimed ranges are critical, and the resulting transdermal absorption rate is not an inherent property but a synergistic effect” and presented unexpected results shown the Examples from the specification. (Remarks, page 9, last paragraph to page 10).
In response, the Examiner disagrees. Applicant’s arguments and evidence of unexpected results as shown in the Examples from the specification are considered, but found insufficient to obviate the standing 103 rejection over Kweon in view of Wang ‘716 and Wang ‘519. This is because Applicant alleged that the results shown in Table 6 of the specification are synergistic effect. However, the data shown in Table 6 is not synergistic effect data, as synergistic data requires showing that the combined action of two or more agents produces an outcome greater than the sum of their individual effects. Synergistic data presentation is normally showed using quantitative metric such as Combination Index (CI). There is no such data shown in the Specification. Thus, the results shown in Table 6 are not considered synergistic data, and is merely showing comparative data of transdermal absorption rates of different formulation examples.
While it is acknowledged that Examples 2-7, 2-8, 2-9, and 2-11 from Table 6 showed high transdermal absorption rates when the mixtures of hyaluronic acids within the scope of the claimed invention was used, these results are not unexpected, because comparative Example 2-4, using a single low molecular weight hyaluronic acid (MW of 1x104 Da) provided a transdermal absorption rate of 79.4%, which also meets the claimed transdermal absorption range of 72% to 93%. Furthermore, Example 2-4 appears to performed better or is superior with respect to transdermal absorption rate when compared to Examples 2-14, 2-16, 2-17, 2-18, 2-19, and 2-20, which are all Examples drawn to mixtures of hyaluronic acids within the scope of the claimed invention. This is preponderance of evidence to show that there is no criticality in the claimed parameters in achieving a result that is unexpected because Table 6, particularly Example 2-4, showed that hyaluronic acid film outside the scope of the claimed invention was also able to provide high transdermal absorption rate.
Furthermore, with any submission of evidence of unexpected results, claim 1 must be commensurate in scope with the particular mixtures of hyaluronic acids that provided superiorly high transdermal absorption rates. See MPEP §716.02(d). Additionally, the claim commensurate in scope with the unexpected results must also be compared to the closest prior art showing by objective evidence that the closest prior art did not achieve high transdermal absorption rates to the same extent as the claimed invention . See MPEP §716.02(e). In this instant case, the closest prior art would be Wang ‘716, as Wang ‘716 teaches the mixtures of hyaluronic acids having two different molecular weights and each hyaluronic acid is used in concentrations that overlaps the claimed concentrations.
With respect to the Applicant’s alleged unexpected results shown in Table 2 of the specification, it is noted that these results drawn to “a film having a transdermal absorption rate of 72% to 93% is formed only when the ultra-small-sized hyaluronic acid (84.0 wt% to 98.5 wt%) and the medium-sized molecular hyaluronic acid (1.5 wt% to 16 wt%) are combined within the claimed ranges, and the film thickness is within the claimed range of 0.01 to 1.5 mm,” are not persuasive because as discussed in the 103 rejection, Kweon teaches the film thickness was particularly 0.1 mm or 1 mm ([0092], [0100], and [0103]), which is within the scope of the claimed range of 0.01 to 1.5 mm. This is preponderance of evidence to show that Applicant’s alleged evidence of unexpected results are not unexpected.
As a result, for at least the reasons discussed above, claims 1, 4, and 10-12 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
