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
The instant application is a national stage entry of PCT/KR2019/010157, filed 08/09/2019, and claims foreign priority to KR10-2018-0142721, filed 11/19/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Foreign priority has been perfected. Therefore, the effective filing date for the instant claims is the international filing date of 8/9/2018.
Response to Arguments
Applicants’ claim amendments and Remarks of 07/06/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Applicants have amended base claim 1 to specify the poorly soluble ingredient and anionic surfactant. These amendments have written description support from the specification (see pages 16 and 19 of the specification).
In regard to the anticipatory rejection over JUNG, this rejection is withdrawn because JUNG does not disclose a method of stabilizing cedrol.
In regard to the obviousness rejection over JUNG, Redavid, and Martin, this rejection is withdrawn. Applicants’ remarks with Examiner’s reply are summarized below:
Applicants perfected foreign priority. Therefore, Redavid is no longer prior art.
Martin discloses cleaning principle of micellar shampoo and does not teach specific ratios of sodium dilauramidoglutamide lysine or conditions for stabilizing cedrol.
Response to Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-7, 13-14, 16, and 20-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention: The nature of the invention pertains to stabilizing cosmetic compositions containing cedrol, Sodium dilauramidoglutamide lysine, and hydrogenated lecithin.
The predictability or unpredictability of the art: MAKING COSMETICS (cited in the PTO-892) discloses that because of the wide variety of cosmetic products, there is no “standard” stability tests that can be prescribed and that there is no one way to guarantee stability given the number of variables and tests (page 1). Therefore, the art of “stabilizing cosmetic compositions” of claim 1 is unpredictable.
The amount of direction or guidance presented: Examiner reviewed the short 21-page instant Specification. On pages 16 and 19, there are examples drawn to different compositions stability.
The presence or absence of working examples: No working examples are shown in the Instant Specification. Applicants do not show any data or evidence that the composition of claim 1 had been tested. There is not an example which uses sodium dialuaradilautamide lysine. Applicants do not provide guidance for the amount of cedrol. Applications also do not have any data or experiments showing the instant composition of claim 1. Lack of a working example is a factor to be considered, especially in a case involving an unpredictable art. See MPEP § 2164.02.
The quantity of experimentation necessary: The quantity of experimentation would be “undue” because of the amount of time and resources needed to experimentally find the amounts of cedrol, sodium dilauarmidoglutamide lysine, and hydrogenated lecithin to form a stable cosmetic composition.
The artisan would not be able to anticipate weight ratios to optimize curcumin, curcuminoid, and piperine in order to lessen the effects of a hangover without undue experimentation, absent working examples from Applicants or the art. Because CHADEAYNE teaches that there is no effective method for reliably preventing and/or alleviating the hangover, the artisan would have to undergo undue experimentation to determine the amounts of “sodium dilauarmidoglutamide lysine with cedrol” from instant claim 1.
Moreover, the lack of a working example is noteworthy. There are no teachings or guidance in the specification which would lessen the amount of experimentation to a reasonable amount. Additionally, a person of ordinary skill in the art would have to engage in undue experimentation to create stable cosmetic composition of cedrol, sodium dilauarmidoglutamide lysine, and hydrogenated lecithin, with no assurance of success.
Thus, claims 1, 4-7, 13-14, 16, and 20-25 are rejected as lacking enablement.
Conclusion
No claims are allowed as written.
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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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
