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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application is a 371 of PCT/KR2022/016646 filed 10/28/2022.
This application also claim foreign benefit of REPUBLIC OF KOREA KR10-2021-0170203 filed 12/01/2021.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, claims 1-12 of the instant application are afforded the effective filing date of 10/28/2022
Information Disclosure Statement
The information disclosure statement (IDS) submitted 05/17/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4 and 10-12, in the reply filed on 03/17/2026 is acknowledged.
Claims 5-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/17/2026.
Status of the Claims
Claims 1-12 are pending in this instant application, of which claims 5-9 are withdrawn at this time being drawn to a nonelected group/invention.
Claims 1-4 and 10-12 are examined herein on the merits for patentability.
Drawings
The drawings are 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.
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 comprises the hyaluronic acid …” as recited in claim 4 is not further limiting from claim 1 because a hyaluronic acid is already present in claim 1 and thus, the limitation of “the hyaluronic acid comprises 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.
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, 3-4, 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 (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).
Since the structural limitation of “a film comprising a hyaluronic acid” as been taught by Kweon, the property of “a transdermal absorption rate in a range of 72% to 95%” as recited in claim 1, would have been construed as an implicit property of the film comprising a hyaluronic acid of Kweon. 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 comprising a hyaluronic acid of Kweon because Wang ‘519 established that a hyaluronic acid composition containing a hyaluronic acid of Kweon 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 3, Kweon teaches the film has a thickness of 0.025 mm to 5 mm ([0026], [0032], [0040]; claim 10), which overlaps the claimed thickness of 0.01 to 1.5 mm. 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 thickness of the film would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
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.
Claim(s) 2 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 (WO 2022/100519 A1; filing date: 5 November 2021; citation and English translation via US 2024/0009107 A1; hereafter as “Wang ‘519”), as applied to claim 1 above, and further in view of Wang et al (EP 3991716A1; filing date: 20 December 2019; hereafter as “Wang ‘716”).
The hyaluronic acid film of claim 1 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 2, 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 LMW hyaluronic acid is present in the composition in an amount from 4.3% w/w to 9% w/w and the HMW 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 LMW hyaluronic acid is present in the composition in an amount from 4.3% w/w to 9% w/w and the HMW 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 LMW hyaluronic acid is present in the composition in an amount from 4.3% w/w to 9% w/w and the HMW 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).
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11298855 in view of Wang et al (WO 2022/100519 A1; filing date: 5 November 2021; citation and English translation via US 2024/0009107 A1; hereafter as “Wang ‘519”).
Although the claims at issue are not identical, they are not patentably distinct from each other because while the claims in the Patent ‘855 being a method of making a hyaluronate film, said hyaluronic acid film obtained in Patent ‘855 is substantially the same in structure as the hyaluronic acid film of the instant claims.
While the claims in Patent ‘855 do not recite the hyaluronic acid film as having the transdermal absorption rate that is recited in the instant claims, it would have been reasonably obvious that the “transdermal absorption rate in a range of 72% to 95%” as recited in the instant claims would have been an implicit property in hyaluronate acid film produced in Patent ‘855 because Wang ‘519 established that a hyaluronic acid composition containing a hyaluronic acid of Patent ‘855 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.
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11298855 in view of Wang ‘519.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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