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 and 3-12 are currently pending and an amendment to the claims filed on 12/19/2025 is acknowledged.
Withdrawn objection/ rejections:
Applicant's amendments and arguments filed 12/19/2025 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 Any rejection and/or objection not specifically addressed below are herein withdrawn.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.
New Grounds of Objection/Rejections --- as necessitated by amendment
Claim Objections
Claims 9 and 11 are objected to minor informalities.
Claim 9 recites “a topical compositoin according to claim 1”, but which would be better to write “the topical composition according to claim 1”.
Claim 11 is not written in a proper Markush-type claim format where the Markush-type claim should recite alternatives in a format such as "selected or chosen from the group consisting of A, B, and C." Alternatively, “selected or chosen from A, B or C” can be used. (see MPEP 2111.03 –II and 2117 and MPEP 2173.05(h)). Appropriate correction is required.
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 3 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.
Specifically, claim 3 depends from canceled claim 2. No claim depends from a canceled claim because it is not clear which claim it is supposed to depend from.
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.
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 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.
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.
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 .
Claims 1 and 3-12 are rejected under 35 U.S.C. 103 as being unpatentable over Farwick et al. (US2015/0118173A1) in view of Chu et al. (WO2018/166758A1, IDS of 05/17/2023, antimicrobial species other than Farwick).
Applicant claims the below claim 1 filed on 12/19/2025:
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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 sanitizing product research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from cosmetics, 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)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Farwick discloses antimicrobial active ingredients are used widely in cosmetic deodorants or antiperspirants, antidandruff and antiacne formulations, etc. ([0002]); this prior art teaches lauric acid isopropanolamide was used as antimicrobial ([0008]). Farwick teaches antimicrobial agent such as phytosphingosine, tretinoin, isotretinoin, etc. ([0035])
In the below embodiment, a deodorant formulation comprising polyol, antimicrobial lipid such as lactic acid, and THPE (see the below embodiment) and the deodorant is topically applied to skin. Although the lactic acid is not disclosed as an antimicrobial agent, it is well known as the antibacterial agent as evidenced by Budhian et al. (claim 1 of US2018/0303090A1), and when the lactic acid is used in the formulation of Farwick, it will reveal antimicrobial properties, and thus, the range of antimicrobial agent can be derived from lactic acid in the below formulation.
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In the above deodorant formulation embodiment, polyols of panthenol and propylene glycol read on the claimed polyhydroxy compound a) and they are present in a total amount of 2.2% that is within the range of 0.01 to 25% of instant claim 4; lactic acid reads on the claimed antimicrobial lipid b) because the lactic acid is well-known antibacterial agent and its amount 0.2% is within the range of 0.0001 to 5% of instant claim 5; Neutrol THPE reads on the claimed THEP c) and its amount 3.75% is within the range of 0.01 to 10% of instant claim 6 and therefore, the ratio of antimicrobial lipid lactic acid (0.2%) to THPE (3.75%) is about 0.05 that is within the ratio of 1:10,000 (=0.0001) to 1:10 (=0.1) of instant claim 1, and the ratio of polyhydroxy (2.2%) to THPE (3.75%) is about 0.59 that is within the ratio of 1:20 (=0.05) - 20:1 (=20) of instant claim 7 (instant claim 1, in part and instant claims 4-7); this prior art teaches an antiacne product comprises antimicrobial agent phytosphingosine ([0035]) (instant claim 3); the formulation is used as disinfecting or cleaning care compositions such as skincare, face care, body care, dental care, oral care, antiperspirant/deodorant product, haircare product, hairspray, hair cream, hair washing compositions, etc. in the form of cream, gel, lotion, spray, deodorant, etc. ([0022], [0026] and [0034]) (instant claim 8); application of the formulation may be advantageous wherever it is desirable to control microorganisms or their growth, e.g., hygiene articles, which can be present in the form of customary rinse-off formulations, and the composition is applied to the surface of a human or animal body part, in particular the skin, the hair or the teeth ([0040]) (instant claims 9-11); and in embodiment, the formulation can be used to reduce the growth of microorganisms, involving steps a) provision of a formulation according to the invention, in particular of a cosmetic or pharmaceutical formulation, b) application of the formulation to the surface to be treated, in particular skin, hair or teeth, in an effective amount, c) leaving the formulation on the surface to be treated for a time which suffices to ensure the reduction in the growth of the microorganisms and d) optionally washing out or rinsing off the formulation (instant claim 12).
Farwick teaches lactic acid ([0077] - Example) and phytosphingosine ([0035]) but it does not expressly teach other antimicrobial lipid of instant claim 1. The deficiency is cured by Chu.
Chu discloses an antimicrobial composition comprising essential oil and antimicrobial lipid (title) wherein the antimicrobial lipid includes sapienic acid, palmitoleic acid, sphingosine, dihydrosphingosine, phytosphingosine, and 6-hydroxysphingosine. These compositions can be delivered through very many different types of personal care products e.g. shampoo, conditioner; face wash or hand wash product; or a leave on cream/ lotion (abstract and claims 1-2 of prior art) (instant claim 1, antimicrobial agent).
It would have been obvious to modify the teachings of Farwick with antimicrobial lipid of Chu in order to enhance antimicrobial effects, and also replacing lactic acid of Farwick with other species of antimicrobial lipid would be a matter of choice or design because such choice would have yielded no more than the predictable antimicrobial effects.
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.
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.
Further, 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).”
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Farwick cites lactic acid in the example without any pointer to one skilled in the art on its role, and Chu teaches an antimicrobial composition comprising essential oil and certain antimicrobial lipids and it is specific to the synergistic antimicrobial effect provided in the presence of essential oils, and the teachings is limited to those specific combination only, and this reference is silent on claimed THPE and polyols, and there is no pointer that the antimicrobial lipids will provide the same synergistic benefit to ingredient other than essential oils, particularly THPE and polyols, and consequently, there is no motivation to replace lactic acid with those of a synergistic benefit.
The Examiner responds that as evidenced by Budhian et al. (e.g., claim 1 of US2018/0303090A1), lactic acid is well-known antimicrobial agent and thus, even though Farwick does not expressly point it out, when the prior art composition contains lactic acid with overlapping amount, it will intrinsically reveal antimicrobial properties; Farwick also teaches phytosphingosine as an antimicrobial agent for anti-acne products ([0035]); and Farwick and Chu both refer to an antimicrobial composition useful for a deodorant (=odor control agent), an antiacne product, and an anti-dandruff, etc., and thus, it would be obvious to add additional antimicrobial agent of Chu to the composition of Farwick in order to enhance the antimicrobial effects and/or replacing the lactic acid of Farwick with antimicrobial agent of Chu would have yielded no more than the predictable results; the Examiner relied on specific antimicrobial agent for the Chu reference, not on essential oils and THPE, and in this context, please note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145. Further, the claimed composition uses “comprising” which does not exclude introduction of any ingredients including lactic acid, essential oils, etc.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
No claims are 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.
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