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 .
Status of the Claims
Claims 1, 5, 6, 8, 11, 13, 17, 18, 20, 24, 29, 33, 39, 42, 52-54 and 70-72 are pending.
Withdrawn rejections:
Applicant's amendments and arguments filed 09/02/2025 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 Any rejection and/or objection not specifically addressed below are herein withdrawn.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.
Claim Objection
Claim 54 is objected to a minor informality.
Claim 54 recites “an emulsifying agent” in line 2, but which would be better to write “the emulsifying agent”. In the alternative, claim 54 may be amended to recite “wherein the optional emulsifying agent is selected from the group consisting of …. And emulsifying blends”.
Appropriate correction is requested.
New Grounds of Rejections --- as necessitated by amendment
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.
Claim 8 is 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.
Dependent claim 8 recites “the solvent is mixture of 1,3-propanediol in combination with a solvent selected from the group consisting of 1,2-propanediol … and dimethyl isosorbide”. However, base claim 1 recites “solvent consisting of 1,3-propanediol”. That is, “consisting of” language in claim 1 is limited to 1,3-propanediol only as the solvent. In this context, please see MPEP 2111.03(II): When the phrase "consisting of" appears in a clause of the body of a claim, rather than immediately following the preamble, there is an "exceptionally strong presumption that a claim term set off with ‘consisting of’ is closed to unrecited elements."
Therefore, it may not be said that claim 8 further limits claim 1 in a proper manner. Appropriate correction is requested.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant claims the below claim 1 filed on 01/12/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical/cosmetic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from hypertension medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Claims 1, 5, 6, 8, 11, 13, 17, 18, 52-54 and 70-72 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US2007/0172436A1, IDS of 04/16/2021 in parent application no. 17/286434).
Zhang teaches a stabilized topical composition for dermatological or cosmetic uses ([0011]) comprising at least 5%, at least 10%, e.g., 10-35% dissolved ascorbic acid ([0031]) which overlaps 5-28% ascorbic acid a) of instant claim 1, about 10 to about 20% of instant claim 13, and about 25% of instant claim 17, 15-25% of instant claim 72, solubilization enhancer of urea, e.g., urea or hydroxyethyl urea or combination in an amount of about 1 to about 40% which overlaps 5 to 20% urea b) of instant claims 1 and 72 ([0008], [0042]-[0044] and [0047], and claim 18 of prior art), and the composition further comprises glycerin and propylene glycol (=1,2-propanediol=C3 alkanediol), 1,3-propanediol, 1,2-butanediol, 1,3-butanediol, 1,2-pentanediol, 1,5-pentanediol, 1,2-hexanediol, 1,6-hexanediol, diethylene glycol, diglycerin, dipropylene glycol, triethylene glycol, 1,2,3-hexanetriol, 1,2,6-hexanetriol, or combinations ([0035]) which reads on the claimed solvent d) and mixture and the amount of solvent is 20-90%, 30-80%, or 40-70% ([0037]) that overlaps the instant range of 50-85%; and this prior art further teaches the ascorbic acid is dissolved in the non-aqueous solvent which can provide a clear solution (e.g., Example 9-10) and the nonaqueous composition to be stable with no evidence of crystal formation or precipitation is evident after one month ([0163]) and therefore, the prior art composition reads on storage stable, and the prior art composition comprises the same ingredients of ascorbic acid, urea, polyol solvent with overlapping amount, and consequently, the claimed composition and the prior art composition are expected to have the same storage stability because the prior art provides the claimed stabilizing composition and stabilizing process of ascorbic acid and storage stability. In this context, see the case laws stating that "Products of identical chemical composition cannot have mutually exclusive properties." 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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” (instant claims 1, 5, 6, 8, 13, 17 and 71). Further the composition comprises tocopherol ([0054]), octyl salicylate ([0064]), and surfactant (=emulsifying agent), etc. ([0068]) (instant claim 1c) and claims 11 and 70); the composition of Example 13 comprises 12% urea, 52% propylene glycol (= 1,2 propanediol), 20% ascorbic acid, 10% safflower oil, and surfactant (=emulsifying agent) polysorbate-80, and Example 14 discloses composition comprising 60% propylene glycol, 12% urea, 20% ascorbic acid, 1% oleth-20, 2% polysorbate-80 and 5% dimethicone which is silicone oil emulsifying agent (instant claims 52-54). Please note that the prior art defines the said nonaqueous composition has less than about 10% water amount ([0025]).
In embodiments, the composition of Zhang comprises 88% propylene glycol, 5% urea, 7% of L-ascorbic acid (Example 6), the composition of Zhang comprises 84% propylene glycol, 5% urea, 6.5% ascorbic acid, 1.5% polysorbate-80 and 3.0% vitamin E acetate which reads 10% or less optional additional ingredients (Example 8); the composition of Zhang comprises 55% propylene glycol, 20% urea, 22% L-ascorbic acid, 2% polysorbate and 1% vitamin E acetate which reads 10% or less optional additional ingredients (Example 9); the composition of Zhang comprises 52% propylene glycol, 15% urea, 20% L-ascorbic acid, 5% polysorbate and 8% vitamin E acetate (Example 10); the composition of Zhang comprises 48% propylene glycol, 5% 1,6-hexanediol, 12% urea, 20% L-ascorbic acid, 5% polysorbate and 10% vitamin E acetate (Example 11); the composition of Zhang comprises 60% propylene glycol, 12% urea, 20% ascorbic acid, 1% oleth-20, 2% polysorbate-80 and 5% dimethicone which reads 10% or less optional additional ingredients (Example 14); the composition of Zhang comprises 57% propylene glycol, 15% methyl urea, 20% ascorbic acid, 1.5%1.5 polysorbate-80, oleth-20, 5% vitamin E acetate (Example 20) and 55% propylene glycol, 15% urea, 25% ascorbic acid, 1.5% polysorbate-80, 3% vitamin E acetate and 0.5% Ultrez 20 (Example 23). Zhang discloses very similar diol solvents and other same ingredients and inside or overlapping amounts thereof (e.g., [0035] and Examples 8-10, 14, 20 and 23) and accordingly would meet the claimed concentration relationship (AA, X, AA-X)*1.25, as supported by instant Table 1 and relevant disclosure on pages 7-10 of instant specification, in the absence of evidence to the contrary (instant claim 1 - concentration). Although the prior art does not expressly teach the exact ratios of instant claim 18, the claimed ratios of ascorbic acid to urea agent 1.8 to 2.2, 2 to 1, 1.0 to 1.3, 1.25 to 1 or 1 to 1 overlaps the ratios of prior art, i.e., 1.1-1.6 of the said Examples (instant claims 18). MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Although Zhang does not expressly teach embodiment of ascorbic acid, urea and 1,3-propanediol with the claimed ranges, it would obvious variation because Zhang teaches 1,3 propanediol, and also embodiments (e.g., Examples 8-10, 14, 20 and 23) provide very similar embodiments of 52-84% 1,2-propanediol, 12-20% urea and 6.5 to 25% ascorbic acid in the absence of evidence to the contrary (instant claim 72).
In light of the foregoing, instant claims 1, 5, 6, 8, 11, 13, 17, 18, 52-54 and 70-72 are obvious over Zhang.
Claims 11, 20, 24, 29, 33, 39 and 42 remain rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US2007/0172436A1, IDS of 04/16/2021 in parent application no. 17/286434) in view of Tanaka et al. (CN101282708A, of record in a parent application no. 17/286434, and citation is obtained from corresponding English translation in the parent case).
However, Zhang does not expressly teach hyaluronic acid, acetyl zingerone, panthenol, azelaic acid and madecassoside of instant claim 11; acetyl zingerone, madecassoside and panthenol of instant claims 11 and 20; ferulic acid of instant claim 24; azelaic acid and its amount of instant claim 29; pine extract and its amount of instant claim 33; glycolic acid/lactic acid/salicylic acid, etc. of instant claim 39; and hydroxy acid and its amount of instant claim 42. The deficiencies are cured by Tanaka.
Tanaka discloses external preparation for use in anti-aging of skin, anti-wrinkling, whitening, moisturizing effects in the form of lotion, emulsion and cream, pack, gel, soap, etc.(abstract, [0020], [0249]) and the preparation comprises ascorbic acids (abstract, [0020] and [0098]), urea ([0026]-[0027] and [0152]-[0153]), hyaluronic acid and as humectants ([0026-0027] and [0302]) (instant claim 11), zingerone and vitamin B group as antioxidant ([0242] and claim 18 of prior art) (instant claim 20), hydroxycinnamic acid (=ferulic acid) as humectants ([0027] and claim 9 of prior art) in an amount of 1% or less ([0122] which overlaps the instant range of about 0.5% (instant claim 24), azelaic acid as humectants (instant claim 11) in an amount of about 5% or less ([0155] and claim 9 of prior art) which overlaps the range 3 to 10% (instant claim 29), pine extract as an skin whitening agent in an amount of 0.0001% or more or about 0.1% or more ([0027], [0124] -[0125]) which overlaps the range 2% or less (instant claim 33) and triterpenoid saponin as additives ([0201]) which is main component of the claimed madecassoside derived from Asclepiadaceae ([0201])(instant claims 11 and 20); lactic acid, glycolic acid, salicylic acid as cell activator in an amount of about 2% or less which is identical to the claimed range ([0026], [0052], [0054] and [0108]) (instant claims 39 and 42); and the composition further comprises pantothenic acid in an amount of about 5% or less ([0102]) (instant claim 20).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the teachings of Zhang with additional ingredients of Tanaka in order to enhance the properties of the topical composition.
Although the applied art alone or in combination does not expressly disclose the claimed additional components other than those of the applied art, they would be obvious as a matter of matter or choice in the relevant field. Selection of them would have yielded no more than the predictable additional effects of the composition.
In light of the foregoing, instant claims 11, 20, 24, 29, 33, 39 and 42 are obvious over Zhang in view of Tanaka.
This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined 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 art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Examples 5-6 of Zhang disclose propylene glycol (=1,2 propanediol) and even if Zhang discloses various polyols may be used, Zhang does not teach or suggest the specifically claimed configuration where the solvent is 1,3-propanediol in a manner that would lead a skilled artisan to reasonably expect achievement of the claimed supersaturation relationship and extended stability characteristics recited in instant claim 1; and further the claimed properties are not inherent because Zhang is directed to propylene glycol and therefore the cited references fail to disclose or render obvious all of the limitations of independent claim 1.
The Examiner would like to have applicant’s attention to MPEP 2141.02[R-5] VI: A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984). It is well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the submitted knowledge in the art, to a person of ordinary skill in the art. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered”) (quoting In re Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)). "[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments. [C]laims may embrace different subject matter than is illustrated in the specific embodiments in the specification." Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc) (citations and internal quotation marks omitted). Rather, "[i]t is the claims that measure the invention." SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985). That is, Zhang teaches/suggests that even non-preferred polyol can be used when considering the prior art as a whole.
Further, Example 6 of Zhang discloses that non-aqueous ascorbic acid composition comprises propylene glycol 88%, urea 5%, and L-ascorbic acid 7%, and the solubility of ascorbic acid in propylene glycol is about 4.6% (see [0116] pf Zhang) and thus, Example 6 of Zhang satisfies the claimed formula: (AA-X)x1.25 = (7-4.6) x 1.25=3 which is ≤ 5 (=the claimed urea minimum amount), and here Example 6 requires urea 5% and therefore, 7% ascorbic acid is fully dissolved in that urea amount, and accordingly, Example 6 of Zhang meets the claimed formula. And, it is noted that Zhang discloses 15 examples (not the laundry list) of polyols in [0035] and thus, the ordinary artisan would have selected 1,3 propanediol as the non-aqueous solvent without undue experimentation, and the properties would be implicit.
Further, there is no fair comparative data between using 1,2-propanediol and using 1,3-propanediol under the same condition that the claimed ranges of ascorbic acid and urea are utilized. Here, the specification provides simple statement “1,2-propanediol induces skin irritation and sensitivity” (see [0119] and [0189] of instant publication), and the test using 1,2-propandiol-containing composition is outside the scope (40%) of the claimed ascorbic acid range (5-28%) (see [0213] of instant publication). Thus, alleged unexpected results could not be confirmed. Furthermore, the instant data requires the amount of solvent 1,3 propanediol, but the claimed invention does not. Therefore, the instant data is not commensurate with the scope of the claimed invention. The claimed storage stability would be expected, unless the applicant demonstrates unexpected results from 1,3 propanediol compared to the same amount of 1,2-propane diol under the same condition.
In light of the foregoing, applicant’s arguments are not persuasive.
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, 5, 6, 8, 11, 13, 17, 18, 20, 24, 29, 33, 39, 42, 46, 52-54 and 70-72 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 78-83, 85-86, 91-95, 97-99, 101, 103, 106, 108 and 111-112 of copending application No. 17/965633.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition containing ascorbic acid, urea agent, optional ingredient including ferulic acid, and alkanediol comprising 1,3-propanediol and the claimed ranges overlap the copending ‘633 ranges; It is also noted that the copending ‘633 claims require additional ingredients such as azelaic acid, madecassoside, hydroxy acid, panthenol, silicone- based oil component, emulsifying agent and acetyl zingerone, which are also found in the instant dependent claims. The difference between them is that instantly claimed composition using the same ingredients has broader ranges thereof while copending ‘633 composition using the same ingredients has claimed ranges that are inside the ranges of the claimed invention, and thus, the copending ‘633 composition renders the instantly claimed invention obvious.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending ‘633 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 Provisional 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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