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 .
It is noted that the examiner assigned to this application has changed.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-17 and 21) and the species where the water-soluble block copolymer is defined claim 3, the emollient is dibutyl adipate, and the emulsifier is nonionic emulsifiers in the reply filed on July 1, 2026 is acknowledged. The traversal is on the ground(s) that the claims are linked by a special technical feature because the composition of claim 1 brings about unexpected results. Applicant points to the tables. This argument is not persuasive because Applicant does not explain how the results are unexpected and claim 1 is not commensurate in scope with the examples in the tables. MPEP 716.02(b) states that appellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Applicant has not sufficiently explained the data provided in the tables at least because Applicant has not compared the data in the tables to the closest prior art or described how the data demonstrate an unexpected result. Additionally, evidence of nonobviousness must be commensurate in scope with the claims for which the evidence is offered to support. See MPEP 716.02(d). The evidence in the tables is not commensurate in scope with the claims at least because the examples use more specific block copolymers, emollients, and emulsifiers than claim 1. In addition, claim 1 does not limit the quantities of these components and is open to additional components not included in the instant tables.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 8, 2026.
Information Disclosure Statement
The information disclosure statement filed April 2, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Applicant has submitted a copy of the second non patent literature document (De Polo), but the copy is of low resolution and is largely illegible. It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claim 16 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “(a) + (b)/9 ≥ 11.5”, and the claim also recites “preferably 25.0 ≥ (a) + (b)/9 ≥ 11.5” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zarket (WO 2020/112595 A1, cited on 3/04/2024 IDS) in view of Barreleiro (DE-102008032179-A1, English translation provided) and evidenced by Buyuktimkin (US-2013/0136805-A1).
Regarding claims 1-3, 5-6, and 8-10, Zarket teaches a thermo-sensitive composition (thermoresponsive oil-in water nanoemulsion. Abstract). The thermo-sensitive composition comprises an amiphiphilic triblock copolymer, an oil, a surfactant, a nonionic co-surfactant, and water and undergoes a sol-to-gel transition (Abstract). The sol-to-gel transition may occur at about 20-40 °C (Zarket, page 5, lines 18-23). In example 1, Zarket exemplifies a composition comprising poloxamer 407 and poloxamer 188 as the amphiphilic triblock copolymer, isopropyl myristate as the oil, polysorbate-80 and sorbitan oleate as the surfactants, poly(ethylene) glycol as the co-surfactant, and water (page 38, lines1-4). This exemplified composition has a sol-to-gel temperature of 35 °C (page 39, line 17).
Poloxamer 407 has a formula of HO(C2H4O)a(C3H6O)b(C2H4O)aH where a is about 101 and b is about 56 (Buyuktimkin, [0101]), reading on the block copolymer of claims 1-3. Poloxamer 188 reads on the block copolymer of claims 1-3 where a is about 80 and b is about 27 (Buyuktimkin, [0098]).
Polysorbate-80 and sorbitan oleate read on a nonionic emulsifier (see page 10, lines 33-36 of the instant specification where polysorbate n-series, sorbitan mono esters are described as emulsifiers).
Zarket’s sol-to-gel transition temperature reads on the claimed texture transition temperature.
Example 1 does not anticipate claim 1 for the elected species because Example 1 includes isopropyl myristate rather than the elected emollient (dibutyl adipate).
However, Zarket teaches that oils other than the isopropyl myristate used in Example 1 can be used to prepare the composition (see page 8, line 18 through page 9, line 13). Zarket teaches that the oil can be fatty esters having at least 10 carbon atoms and that these esters can be dicarboxylic acid esters (page 10, lines 9-12). Zarket’s oils further include hydrocarbon-based oils of plant origin, synthetic esters and ethers, linear or branched hydrocarbons, linear alkanes, and fatty alcohols. Given Zarket’s disclosure, one of ordinary skill would understand that the composition of Zarket could be prepared using a wide range of oils, including dicarboxylic esters with at least 10 carbon atoms.
Prior to the effective filing date, dibutyl adipate was known as a suitable oil for use in cosmetic applications, as taught by Barreleiro. Barreleiro teaches oil-containing compositions used in contact with skin (Barreleiro, [0013-0014]). The oils taught by Barreleiro include ester oils (Barreleiro, [0071]). Barreleiro teaches dibutyl adipate as a particularly preferred oil (Barreleiro, [0071]). Other oils specified by both Barreleiro and Zarket include shea butter, sweet almond oil, and triglycerides of capric acid (Barreleiro, [0071]; Zarket, page 8, lines 20-30 through page 9, line 13). Given the disclosure of Barreleiro, one of ordinary skill in the art would have understood that dibutyl adipate could be used as an oil alternative to the oils taught by Zarket.
Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007). MPEP § 2143, rationale (B). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to have substituted the oil of Zarket for the dibutyl adipate of Barreleiro. One would have had a reasonable expectation of success because Zarket teaches that the oil can be dicarboxylic esters with at least 10 carbon atoms. Dibutyl adipate is the reaction product of adipic acid and n-butanol (claims 5-6 and 8-10).
Regarding claims 4, 15-16, modified Zarket teaches the thermo-sensitive composition of claim 1.
Zarket does not anticipate a composition that satisfies the relationship (a) + (b)/9 ≥ 11.5.
However, Zarket teaches that the amphiphilic triblock copolymers (instant (a)) can be present in an amount of 1-15 wt% and the oils (instant (b)) can be present in an amount of 10-50 wt% (page 33, lines 17-25). It would have been obvious to one of ordinary skill in the art prior to the effective filing date to select any amphiphilic triblock copolymer content in the range of 1-15 wt% and any oil content in the range of 10-50 wt% because Zarket teaches these contents. A range of 1-15 wt% overlaps with the claimed range of greater than or equal to 5% by weight of component (a) (claims 4 and 16). These contents correspond to (a) + (b)/9 in the range of about 2.1-20.6 (1+10/9=2.11 and 15+50/9=20.55). A range of 20.6 ≥ (a) + (b)/9 ≥ 2.1 overlaps with the claimed range of (a) + (b)/9 ≥ 11.5 (claims 15-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claim 7 and 11-13, modified Zarket teaches the thermo-sensitive composition of claim 1. Modified Zarket teaches a species comprising an ester-based emollient where the ester is formed by an acid and an alcohol where the acid moiety is derived from a dicarboxylic acid (adipic acid) and the alcohol moiety is derived from a mono-alcohol (n-butanol). Further limitations of the monocarboxylic acids, as claimed in claim 7, are obvious over the rejection of claim 6 over Zarket because claim 6 does not require the use of dicarboxylic acids when monocarboxylic acids are used. Similarly, further limitations of the diols or polyols, as claimed in claims 11 and 12, are obvious over the rejection of claim 9 over Zarket because claim 9 does not require the use of diols or polyols when mono-alcohols are used. Further limitations of the alkane, as claimed in claim 13, are obvious over the rejection of claim 1 over Zarket because claim 1 does not require an alkane-based emollient when an ester-based emollient is used.
Regarding claims 14 and 17, modified Zarket teaches the thermo-sensitive composition of claim 1. In Example 1, Zarket exemplifies 20 wt% oil (page 38, lines 1-5). An oil content of 20 wt% reads on the claimed component (b)/emulsifier content.
Regarding claim 21, modified Zarket teaches the thermo-sensitive composition of claim 1. Zarket further teaches that the composition can be used in cosmetic applications and can comprise active ingredients (abstract). Zarket teaches that the active ingredient is capable of being dissolved in the oil droplets of the nanoemulsion (page 29, lines 26-29). Based on this description, the oil droplets read on a carrier. Zarket therefore teaches a cosmetic composition comprising the thermo-sensitive composition of claim 1, an active ingredient, and a carrier.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDRA DESTEFANO whose telephone number is (703)756-1404. The examiner can normally be reached Monday-Friday 9-5.
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/AUDRA J DESTEFANO/Examiner, Art Unit 1766
/RANDY P GULAKOWSKI/Supervisory Patent Examiner, Art Unit 1766
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