Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 July 2025 has been entered.
Election/Restriction
Newly submitted claim 28 is directed to the non-elected species, silica, per the Applicants response to the Election/Restriction requirement (See response dated 01/30/2023). Accordingly, claim 28 is withdrawn from consideration as being directed to a non-elected invention.
Claim Status
Applicant’s arguments, filed 09 July 2025, are acknowledged and have been fully considered.
Claims 1, 4, 5, 23, 24 & 26-28 are pending.
Claims 2, 3, 6-22 & 25 are cancelled.
No claims are amended.
Claims 23, 24 & 28 are withdrawn.
Claims 1, 4, 5, 26 & 27 have been examined on the merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Examination on the merits is to the extent of the following species:
Stationary Phase- Dibutyl adipate;
B. Gel Former- stearalkonium hectorite;
-and-
C. UV Filter- compound TR2.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record.
Declaration Filed Under § 1.132
The declaration filed on 09 July 2025 by Applicant is acknowledged. The declaration is addressed in the response to Applicant’s traverse below.
Maintained Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 4, 5, 26 & 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Acker (US 2010/0111884; IDS filed 10/06/2021; previously cited), Evans (US 4,238,509; IDS filed 10/06/2021; previously cited) and Lee (US 2009/0269374; IDS filed 10/06/2021; previously cited) and as evidenced by Pratley (US 2007/0166262; IDS filed 10/06/2021; previously cited).
Acker teaches UV absorber formulations (title). With regard to claim 1, Acker teaches their UV filter compositions comprise a) an organic UV absorber of Formula 1, b) dimethyl capramide, c) a cosmetically acceptable carrier and water (abstract). With regard to claims 1 & 26, Acker teaches the Formula 1 UV absorber may be Bis-Ethylhexyloxyphenol Methoxyphenyl triazine/Methoxyphenyl Triazine/Tinosorb S/bemotrizinol/(TR2) and exemplifies its inclusion in the Example 28 & 29 sunscreen oleogels in an amount of 1-7% of the Example 28 & 29 sunscreen oleogel formulations (title; abstract, pg. 35 & 36). With regard to claims 1 & 26, more broadly, Acker teaches the UV absorber compositions of their invention comprise 20-70% component (a) which may be bemotrizinol/(TR2) and that cosmetics or pharmaceutical preparations comprise 0.05 to 80% of the UV absorber compositions; thereby Acker teaches the preparations, which may be sunscreen oleogel compositions, comprise 0.01-56% of the component (a) ultra-violet absorber which may be bemotrizinol/(TR2)(Acker’s claims 9 & 11). Acker teaches cosmetic or pharmaceutical preparations containing the UV absorber composition of their invention [0116]. The cosmetic or pharmaceutical preparations may be, for example, gels [0117]. With regard to claim 1, Acker then teaches “[c]osmetic or pharmaceutical formulations are contained in a wide variety of cosmetic preparations” which include light-protective preparations, such as sun milks and sunblocks (emphasis added; [0120] & [0126]). With regard to claim 1, thereby, Acker teaches the method step of adding at least one UV filter, which may be bemotrizinol/(TR2) to an oleogel “to provide a sunscreen composition comprising the oleogel and the at least one organic UV filter “ (pg. 35). With regard to claims 1, 4, & 26, Acker in the Example 28 Sunscreen oleogel teaches inclusion of isopropyl myristate (i.e. (sp2) stationary phase) in an amount of 13-38% of the composition and the gel former, disteardimonium hectorite (pg. 35). With regard to claims 1 & 26, Acker in Example 28 teaches inclusion of isopropyl myristate in an amount of 13-38% of the composition; Acker teaches isopropyl myristate and dibutyl adipate are equivalent cosmetic esters for inclusion in the formulation as lipophilic emollients ([0081], [0085] & [0086]). With regard to claims 1 & 26, thereby, it would have been obvious to the ordinary skilled artisan to substitute the isopropyl myristate present in the Example 28 oleogel with dibutyl adipate because they are both cosmetic esters which function as lipophilic emollients, yielding an oleogel comprising 13-38% dibutyl adipate/stationary phase. With regard to claims 1, 5 & 27, Acker’s Example 28 sunscreen oleogel comprises propylene carbonate in an amount of 5% (pg. 35). Acker in Example 28 teaches inclusion of the gel former, distearalkonium hectorite (a hydrophobically modified hectorite) in an amount of 15%.
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However, Acker does not teach the gel former is stearalkonium hectorite which is present in an amount of 3.25-13 wt. % of the formulation.
With regard to claims 1, 4, 5 & 26, and the elected species, Evans teaches oat flour-oil gel crème (title). Evans teaches organically-modified smectite clays, such as bentonite and hectorite, are well known gelling agents for cosmetic oils (col. 2, lines 15-35). With regard to claims 4, 5, 26 & 27, typically, preformed commercial gels contain about 10% gellant (quaternary ammonium bentonite or hectorite) and about 3% propylene carbonate (col. 2, lines 15-35).
With regard to claims 1, 4, 5 & 26, and the elected species, Lee teaches cosmetic compositions which may be formulated as a sun lotion, or a sun cream [0030]. Lee teaches organic hectorite is used in their invention for enhancing skin covering power and may be preferably selected from the group consisting of disteardimonium hectorite (i.e. a hydrophobically modified hectorite), Quaternium-18 hectorite, stearalkonium hectorite (i.e. a hydrophobically modified hectorite), and a combination thereof [0022]. With regard to claim 26, Lee teaches their composition may include propylene carbonate as a volatile oil [0017]. With regard to claim 26, as evidenced by Pratley, stearalkonium hectorite is an oil dispersible, hydrophobically modified clay which is a structurant [0029]. With regard to claim 26, evidentiary reference Pratley teaches in oil phases containing a polar activator, including the activator propylene carbonate, the activator polarizes the edges of hydrophobically modified clay platelets so the clay platelets form a network structure when dispersed in oil through polar interaction (i.e. a 3-dimensional meshwork; [0026-[0029]). With regard to claim 26, since gels are semi-solids, Ackers dibutyl adipate (a liquid oil) contained within Acker’s oleogel is necessarily non-continuous and stationary (Example 28-pg. 35).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (G) may be employed in which it would have been obvious to the person of ordinary skill at the time of the invention to have modified the Acker’s sunscreen oleogel by substituting Acker’s disteardimonium hectorite with stearalkonium hectorite as suggested Lee and adjusting the amount of stearalkonium hectorite to be 10-15% as suggested by the combined teachings of Evans and Acker and adjusting the amount of propylene carbonate to be 3-5% as suggested by the combined teachings of Acker and Evans because disteardimonium hectorite and stearalkonium hectorite are both hectorites used for enhancing skin covering power in suncare compositions and Acker’s sunscreen oleogel contains smectite clays which are typically used in gels in an amount of 10%-15% and Acker’s oleogel contains propylene carbonate which is used as a wetting agent in an amount of 3-5% in gels as suggested by the combined teachings of Acker and Evans. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to modify the skin covering powder of the sunscreen oleogel by adjusting the amount of reagents to amounts known in the art and commercially used.
With regard to the recited amounts of UV filter (b) bemotrizinol/(TR2), dibutyl adipate stationary phase, stearalkonium hectorite gel former and propylene carbonate, the combined teachings of Acker, Evans, and Lee teach these parameters in amounts that overlap or fall within the recited range. In 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicant is reminded a range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Declarant re-creates Example 28F of Acker in which 38% isopropyl myristate is present and compares the SPF of this formulation to that in which 38% diethylhexyl carbonate or dibutyl adipate are present as stationary phase of the oleogel (Declaration, paragraph 10-Table). Acker teaches isopropyl myristate and dibutyl adipate are equivalent cosmetic esters for inclusion in the formulation as lipophilic emollients ([0081], [0085] & [0086]). The SPF achieved with the composition comprising isopropyl myristate was 13 while the SPF achieved with the composition comprising dibutyl adipate or diethyl carbonate was 16 (Declaration, paragraph 10-Table). Declarant argues this increase in SPF is an improvement that is unexpected because the Tinsorb S UV filter was effectively dissolved in all formulations (Declaration, paragraph 11). Applicant’s representative argues dibutyl adipate or diethylhexyl carbonate “dramatically increases SPF” (reply, pg. 6). Applicant argues this unexpected effect is enough to overcome the case of obviousness (reply, pg. 7).
This is not persuasive. With regard to the proffered data, the Examiner notes that it is much more narrow than what is claimed by claim 1. Claim 1 is generic to the amounts of UV filter, stationary phase (i.e. dibutyl adipate or diethylhexyl carbonate), gel former (i.e. stearalkonium hectorite), and propylene carbonate. "[O]bjective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
With regard to increased SPF when dibutyl adipate or diethylhexyl carbonate was used instead of isopropyl myristate (i.e. SPF of 16 versus 13), Applicant does not give us error limits or standard deviations for the measurements. Applicant does not perform statistical tests to determine whether just a 3 unit difference in SPF is a significant difference or explain their proffered data. Applicant does not indicate whether the differences in SPF are mere differences in degree versus difference in kind. “A difference of degree is not as persuasive as a difference in kind – i.e., if the range produces ‘a new property dissimilar to the known property,’ rather than producing a predictable result but to an unexpected extent.” (see MPEP 2144.05. III. A.). Further, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense") (from MPEP 716.02).
With regard to Applicant’s representatives allegation that the increase in SPF is dramatic, the Examiner again notes that no statistical tests have been performed, the error in the measurements is unknown, and no evidence pertaining to the significance between the SPF values has been given. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)
Applicant reiterates the argument that there is inadequate guidance to the recited dibutyl adipate or diethylhexyl carbonate (reply, pg. 7). Applicant reiterates the argument that isopropyl myristate and dibutyl adipate are not equivalents (reply, pg. 7). Applicant reiterates the argument that there is an extensive amount of esters listed to which the species of dibutyl adipate and isopropyl myristate belong (reply, pg. 7).
This is not persuasive. With regard to the arguments pertaining to the amount esters and lack of guidance, Acker teaches dibutyl adipate to be a suitable ester for use in their compositions and shows a pattern of preference for it by exemplifying its inclusion in the Example 8 suncream ([0086]; pg. 21). With regard to Applicant’s argument that isopropyl adipate and isopropyl myristate are not equivalents, Acker teaches dibutyl adipate and isopropyl myristate to both be suitable lipophilic emollient esters. “The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination” (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” 325 U.S. at 335, 65 USPQ at 301.). Applicant has not provided unexpected results showing that dibutyl adipate performs unexpectedly better than any of the other lipophilic emollients and especially isopropyl myristate. While the examples of the instant specification state that six cosmetic oils were examined, the instant specification does not disclose what these cosmetic oils were (see Example 1; pg. 17). Further, page 12 of the instant specification teaches isopropyl myristate to be suitable oil component.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619