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 .
DETAILED ACTION
Claims 1-27 are currently pending and amendments to the claims filed on 02/25/2026 are acknowledged. As a result, claims 1-27 are examined on the merits to which the following grounds of rejections are applicable.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/25/2026 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Withdrawn rejections:
Applicant's amendments and arguments filed 02/25/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
Maintained Rejection
Claim Rejections - 35 USC § 112
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 19-22 remain 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.
Claim 19 recites the term “maintaining a healthy level of skin moisture”, but it is a relative term which renders the claim indefinite. The term is not defined by the claim, and also the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the term is unclear. Appropriate correction and/or explanation are requested.
Its dependent claims 20-22 are also rejected due to the rejection of base claim 19.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that as evidenced by Dr. Winter, the claimed limitation of “maintaining a healthy level of skin moisture” is not indefinite because the limitation is well understood in the field as “maintaining elasticity, smooth, and softness of the skin”.
The Examiner responds that the key question is whether an ordinary artisan can determine the scope of the claim with reasonable certainty, and applicant’s arguments that the artisans associate “healthy skin” with qualities like elasticity, smoothness and softness may still leave the boundary unclear. Which parameter should be maintained? How much softness, smoothness and/or elasticity qualifies as “healthy”. It appears that the specification explicitly defines the phrase “healthy level of moisture” or “healthy skin”, or provides “objective tests” and accordingly, applicant’s arguments are not persuasive. Consequently, the limitation is still unclear and
New Grounds of Rejections --- as necessitated 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.
Claim Rejections - 35 USC § 102
(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.
Claims 1, 2, 10, 11-15 and 15-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al. (EP1690525A1).
Applicant claims the below claim 1 filed on 02/25/2026:
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Prior Art
Ho discloses one or two gamma-polyglutamic acid (PGA) or its salt as a skin moisturizer in a cosmetic or personal care product wherein one of the PGA has a low Mw of 100,000 (=100kDa) (e.g., abstract and the claims 1 and 7) that is identical to the claimed range and the product can additional ingredient such as stearic acid, stearyl alcohol, KOH, Wichenol 158 (e.g., experimental example 1) that reads on the claimed acceptable carrier, and the product is provided in the form of hand-care, foot-care, face-care (e.g., [0021] and claim 8 of prior art) that reads on the claimed topical application to hand, foot and face area (instant claims 1, 2, 15, 16, 19 and 20); and the product is applied in the form of e.g., moisture cream (e.g., the Examples) which reads on the topical application as a cream (instant claims 10-11, 17-18 and 21-22).
In light of the foregoing, instant claims 1, 2, 10, 11 and 15-22 are anticipated by Ho.
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.
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.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (EP1690525A1) as applied to instant claims 1, 2, 10, 11 and 15-22 in view of Yishan et al. (CN103800219A, IDS of 10/17/2023, the citation is obtained from the corresponding Google English translation – previously attached).
Applicant claims instant claim 1 as noted above.
Prior Art
Ho was discussed with respect to instant claims 1, 2, 10, 11 and 15-22.
Ho discloses the product can be present in a mixtures of PGAs (e.g., claim 1 of prior art); and PGA has a low Mw of 100,000 (=100kDa) to 500,000 (=500kDa) or a high Mw of 106 x 3x106 (e.g., claim 7 of prior art), and both are effective to be used as moisturizer for skin dryness (see entire document).
However, Ho does not expressly teach second PGA having a Mw 700kDa. The deficiency is cured by Yishan.
Yishan discloses two kinds of polyglutamic acids and carrier for skin moisturizing (see entire document); and Yishan also discloses one PGA having 1000 to 10000 Da molecular weight (=1kDa to 10kDa) and the other PGA has 700,000Da to 1,200,000Da (=700kDa to 1,200kDa)(e.g., abstract and claim 2 of Yishan).
Therefore, it would have been obvious to combine Ho with Yishan to produce the claimed invention from the standpoint of one of the ordinary artisan because each applied art discloses that PGAs with various Mw are useful to treat skin dryness, and in particular, as noted above, PGA with low Mw (100kDa) of Ho and PGA with high Mw (700kDa) of Yishan are effective as a moisturizer for dry skin and thus, it is prima facie obvious to combine two elements of PGAs known by the said art as useful for the same skin moisturizer purpose to produce a third element, a mixture of PGAs having 100kDa and 700kDa for achieving the same purpose. In this context, please see MPEP §2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (instant claim 14).
Ho in view of Yishan does not expressly teach three to five PGAs which have different molecular weights. However, Ho discloses a mixture of PGA and its salts (e.g., [0010] and claim 1 of Ho) and the PGAs provide desired functionalities including high moisturization and water retention, improved wet-ability and low TEWL (trans-epidermal water loss), soft and tender feel, smooth and dryness, long lasting effectiveness, enhancing skin elasticity, good biocompatibility and enhancing health condition of the skin ([0001]), and Yishan teaches low molecular weight PGA can stimulate fibroblast growth and high molecular weight PGA has more obvious effects on inhibiting melanin production (see e.g., second para. on translation page 3) and the combination of low Mw 100kDa PGA and high 700kDa Mw PGA would provide multifunctional high efficiency moisturizing effects while suppressing melanin production and accordingly, it would have been obvious to provide more than two kinds of PGAs in order to strengthen or enhance the multi-functional properties of the composition (instant claims 3-9).
Although the applied art does not expressly teach other types of formulations such as ointment and gel, they would be an obvious variation of topical skin moisturizer from the standpoint of the ordinary artisan (instant claims 12-13)
In light of the foregoing, claims 1-22 are obvious over Ho in view of Yishan.
Response to Arguments
Applicant’s arguments have been fully considered, but are moot in view of new reference of Ho. Further, the instant specification does not present a comparison data between using inside range of PGA and using outside range of PGA in order to demonstrate criticality of the claimed Mw ranges of two or more PGA.
Claims 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO2019/221531A1, citation is obtained from its corresponding Google English Translation as attached) in view of Ho et al. (EP1690525A1).
Applicant claim the below claim 23 filed on 02/25/2026:
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Prior Art
Park discloses a composition containing poly-gamma-glutamate (PGA) for improving women’s vaginal health, in particular, by inhibiting the growth of e.g., candida albicans yeast, and the composition contains poly-gamma-glutamate and dermatologically carrier such as water and glycerin and applied the composition to the surface of vaginal area (e.g., Example 1); the vaginal health includes inhibition or prevention of vaginitis, itching, moisture loss and odor (e.g., abstract) where hormonal changes after menopause increases sensitivity to vaginitis (e.g., last second paragraph on translation page 1) which reads on the claimed symptom of menopause, and the composition is applied to skin area to improve skin elasticity, skin moisture loss and skin ton, and the composition also is applied to improve female vaginal health helping to improve vulva itching and odor relief (e.g., fourth paragraph on translation page 2 and last fifth paragraph on translation page 4) (instant claim 23 (in part) and claim 24); and the skin area and vaginal area are part of body and thus both read on the claimed body area (instant claim 25); and the composition is in the form of gel, liquid, spray, and body cleaner (e.g., translation page 4) which reads on the claimed topical gel (instant claims 26-27).
However, Park does not expressly teach 100kDa PGA of instant claim 23 reciting all the limitation of claim 1. The deficiency is cured by Ho.
Ho discloses one or two gamma-polyglutamic acid (PGA) or its salt as a skin moisturizer in a cosmetic or personal care product wherein one of the PGA has a low Mw of 100,000 (=100kDa) (e.g., abstract and the claims 1 and 7) that is identical to the claimed range and the produce can contain additional ingredient such as stearic acid, stearyl alcohol, KOH, Wichenol 158 (e.g., experimental example 1) that reads on the claimed acceptable carrier, and the product is provided in the form of hand-care, foot-care, face-are (e.g., [0021] and claim 8 of prior art); and the composition is applied in the form of e.g., moisture cream (e.g., the Examples) to treat the skin dryness ([0002])(100kDa PGA – claim 23).
It would have been prima facie obvious to modify the PGA of Park with that of Ho in order to enhance treatment of skin dryness including vaginal dryness from menopause.
In light of the foregoing, instant claims 23-27 are obvious over Park in view of Ho.
Response to Arguments
Applicant’s arguments have been fully considered, but are moot in view of new reference of Ho.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9, 14, 15, 17, 19, 21, 23, 24 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 23-25 of patent No. 12,357,655B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require one or more polyglutamic acids having overlapping molecular weights including 100kDa and 700kDaand pharmaceutically acceptable carrier for treating skin dryness, maintaining a healthy level of skin moisture, and/or treating and/or ameliorating one or more symptoms of menopause. The difference between them is that patent ‘655 is directed to a method of treating while instant claims 1-14 are directed to a composition. However, the patent ‘655 methods requires administering the same composition as the instantly claimed invention; and further the difference between them is that patent ‘655 requires vaginal dryness while the instant method claims require treatment of skin dryness (instant claim 15)/maintaining a healthy level of skin moisture (instant claim 19)/symptoms of menopause symptom (instant claim 23). However, vaginal dryness is a specific type of skin dryness. Consequently, one of the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
Claims 1-9, 14, 15, 17, 19, 21, 23, 24 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application No. 19/242073.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require one or more polyglutamic acids having overlapping molecular weights including 100kDa and 700kDa and pharmaceutically acceptable carrier. The difference between them is that copending ‘073 is directed to a method of treating vaginal dryness, maintaining a healthy level of vaginal moisture, or treating and/or ameliorating one or more symptoms of menopause while the claimed invention is directed to both composition and methods of use. However, the method of copending ‘073 requires administering the same composition as the instantly claimed invention. Further, the difference between them is that copending ‘073 requires vaginal dryness of pre- or post-menopause while the instant method claims require treatment of skin dryness (instant claim 15)/maintaining a healthy level of skin moisture (instant claim 19)/symptoms of menopause symptom (instant claim 23). However, vaginal dryness is a specific type of skin dryness. Consequently, one of the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending ‘073 subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Response to Arguments
For the reasons set forth above, this double patenting rejection has maintained as Applicants have deferred to rebut the rejection under Rejection, Obviousness Type Double Patenting.
Conclusion
All examined claims are rejected.
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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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