DETAILED ACTION
Applicants’ arguments, filed 16 July 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Withdrawn Anticipation Rejection
Previously in the prosecution history, the examiner rejected the instant claims as anticipated by Page et al. (US 2019/0336420 A1). This rejection has been withdrawn in view of the claim amendments. Specifically, the examiner relied upon the examples in the table on the left column of page 9 of Page. See page 6 of the prior office action, in which the examiner noted the following teaching.
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However, in the claim set on 16 July 2026, the claim has been amended to no longer recite octyldodecanol as a polar oil. The above-indicated example from page 9 of page and reproduced on page 6 of the prior office action comprises octyldodecanol as the polar oil. As such, in view of the claim amendment crossing out octyldodecanol, the above-indicated example is no longer within the claim scope and does not anticipate the instantly claimed invention.
The examiner clarifies that this decision to withdraw the previously applied rejection applies only to the previously applied anticipation rejection over Page. It does not apply to obviousness rejections over Page.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
Claims 1-20 are 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.
Claim 1 recites that the composition is a single-phase composition. However, claim 11, which depends upon claim 1, recites a ratio of oily phase to hydrophilic phase. The requirement of claim 11 appears to indicate that the composition is not a single-phase composition. As such, it is unclear whether the claims require a single-phase composition or a multiple phase composition.
For the purposes of examination under prior art, the examiner will proceed with the understanding that the claims require either a single-phase composition or a multiple phase composition.
Response to Arguments Regarding Indefiniteness Rejections
In applicant’s response on 16 July 2026 (hereafter referred to as applicant’s response), applicant argues that the claim amendments overcome the previously applied indefiniteness rejections. See applicant’s response on page 8.
This is not persuasive. Claim 11 recites the following:
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From the above-reproduced claim requirement, the skilled artisan would have understood that the water-miscible solvent is separate from the oily phase. This would have appeared to have resulted in a composition having two phases; namely, the oily phase as a first phase and the water-miscible solvent as the second phase. As such, it remains unclear whether the recited composition has two phases, as is apparent from claim 11, or is a single-phase composition, as required by claim 1.
The examiner further notes here that applicant makes the following arguments at the bottom of page 10 in regard to the previously applied obviousness rejection; these arguments will be addressed here because they appear to be relevant to the issue of indefiniteness.
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The examiner takes the position that the phrase “mainly oily” would not necessarily appear to imply a single-phase composition. This is because the examiner notes that the prior are is replete with compositions that can be considered “mainly oil” but are not single-phase compositions. For example, a hypothetical water-in-oil emulsion having 20% aqueous phase and 80% oil phase can be considered mainly oily, but is not a single-phase composition. (The examiner notes here that an emulsion is, by definition, not single phase because an emulsion includes a dispersed phase and separate continuous phase).
In support of this position, the examiner notes Shirao et al. (US 2010/0233103 A1), drawn to a water-in-oil sunscreen composition, as of the title and abstract. Shirao teaches that the composition can have up to 80% oil with the remainder being water, as of Shirao, paragraph 0054.
The examiner notes that Shirao, although a newly cited reference, is not part of the statement of rejection. Shirao has been newly cited in order to rebut applicant’s argument that a composition that is “mainly oil” is a single-phase composition.
Claim Rejections - 35 USC § 103 – Obviousness
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.
The factual inquiries 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.
Claim(s) 1-13 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page et al. (US 2019/0336420 A1).
Page et al. (hereafter referred to as Page) is drawn to a cosmetic composition having a polar oil, a C2-C6 aliphatic monoalcohol, a polyol, a hydrophilic active agent, and less than 7% by weight of water, as of the title and abstract.
As to claim 1, the claim requires that the composition is transparent. Page teaches this as of at least paragraph 0022 and 0045.
As to claim 1, the claim requires a single-phase cosmetic. Page appears to teach this as of paragraph 0045. The examiner notes that Page also indicates that the term “homogeneous” is used in place of “single-phase”, as of Page, paragraph 0023, and Page appears to indicate that the final product is homogeneous, as of paragraph 0192.
As to claim 1, the claim requires from 35% to 80% of a polar oil selected from a particular group. Page teaches 45% to 56% of polar oil, as of Page paragraph 0047. Page teaches isopropyl myristate as of paragraph 0071. The isopropyl myristate of Page appears to be an ester, as of page, paragraph 0070, which itself appears to be a non-volatile polar oil, as of Page, paragraph 0060. Page also teaches dialkyl carbonates in paragraph 0076; these also appear to be non-volatile polar oils. The examiner notes that non-volatile polar oils and dialkyl carbonates appear to be chosen from a long list of polar oils. As such, Page is not understood to be anticipatory because these have not been taught in a single example with the other required ingredients. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 1, the claim requires 10% to 60% of polyols having 2 to 20 carbon atoms. Page teaches 15% to 25% of polyols as of paragraph 0016. Page teaches polyols having 3 to 8 carbon atoms, as of paragraph 0120.
As to claim 1, the claim recites an optional C2-C6 monoalcohol. Page teaches this as of paragraphs 0112-0115.
As to claim 1, the claim requires at least one hydrophilic active agent. Page teaches this in the title.
As to claim 1, the claim requires less than 8% water by weight. Page teaches less than 7% water by weight, as of the title, which is within the claim scope.
Page teaches 45% to 56% of polar oil, as of Page paragraph 0047. This overlaps with the requirement of 40% to 75% of polar oil. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 2, the total amount of all of the polar oils combined in Page appears to be 51.38%; this is in the range of 40% to 75% required by the instant claims.
As to claim 3, Page teaches dicaprylyl carbonate in paragraphs 0076 and 0085.
As to claim 4, Page teaches dicaprylyl carbonate in paragraphs 0076 and 0085 and isopropyl myristate in paragraph 0071. Page also teaches 30% to 89% of a polar oil in the abstract; this appears to overlap with the required 32% to 60%.
As to claim 5, Page teaches dicaprylyl carbonate in paragraphs 0076 and 0085 and isopropyl myristate in paragraph 0071. As best understood by the examiner, these appear to be polar alcohols; as such, the skilled artisan would have been motivated to have modified their combination to have been between 30% and 89%, as of Page abstract, because Page teaches this to be the total amount of polar oils. This amount overlaps with the claimed amount. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 6, the examiner notes that the claim does not actually require octyldodecanol or oleic acid, as these components are optional and can be 0%. The claim therefore requires from 7% to 35% of isopropyl myristate or dicaprylyl carbonate. As best understood by the examiner, these appear to be polar alcohols; as such, the skilled artisan would have been motivated to have modified their combination to have been between 30% and 89%, as of Page abstract. This amount overlaps with the claimed amount. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). Therefore, claim 6 has been rejected for essentially the same reason that claim 5 has been rejected.
As to claim 7, Page teaches 0% to 4% water in paragraphs 0041-0042.
As to claim 8, Page teaches pentylene glycol in paragraphs 0123-0124.
As to claim 9, Page teaches 15% to 25% of polyols as of paragraph 0016. Page teaches polyols having 3 to 8 carbon atoms, as of paragraph 0120. This overlaps with the required 20% to 60%. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 10, Page teaches 10% to 45% of aliphatic monoalcohol, as of paragraph 0112. This overlaps with the claimed requirements. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 11, Page teaches three compositions in the table on page 9, left column. As best understood by the examiner, in this table, phases A1, A2, and A3 are the water-miscible organic solvent phase, and phase B is the oily phase. In the first column of the table, Page teaches that the composition has (0.1+8.67+23.35+1.5+15)% of the “A” phases, this is about 48.62%. The remainder of the composition is the “B” oil phase, and this is present in an amount of about 51.32%. This is close to a 1:1 ratio and is within the claim scope.
As to claim 12, Page appears to teach the required chemical structure in paragraphs 0130-0147.
As to claim 13, Page appears to teach active agents present in an amount of 0.1% to 10% in paragraph 0178.
As to claims 15-16, Page teaches treatment of the skin of the body and face as of at least paragraph 0003.
As to claim 17, Page teaches dicaprylyl carbonate as of at least paragraph 0076.
As to claim 18, Page teaches dicaprylyl carbonate in paragraphs 0076 and 0085 and isopropyl myristate in paragraph 0071, along with other polar oils. Page teaches 15% to 25% of polyols as of paragraph 0016. Page teaches polyols having 3 to 8 carbon atoms, as of paragraph 0120. Page teaches a non-volatile polar oil as of paragraphs 0060-0065. The sum of the pentylene glycol and ethanol in the examples in paragraph 0189 of Page appears to be about 23.35% + 15%, which is equal to 38.35%, which in the range of 32 % to 60%.
As to claim 19, this claim is rejected for essentially the same reason that claim 18 is rejected.
As to claim 20, Page teaches dicaprylyl carbonate in paragraphs 0076 and 0085 and isopropyl myristate in paragraph 0071. As best understood by the examiner, these appear to be polar alcohols; as such, the skilled artisan would have been motivated to have modified their combination to have been between 30% and 89%, as of Page abstract. This amount overlaps with the claimed amount. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page et al. (US 2019/0336420 A1) in view of Perez Nowak et al. (US 2018/0140515 A1).
Page is drawn to a composition comprising a polar oil which may include isopropyl myristate or dicaprylyl carbonate, a polyol, ethanol, a hydrophilic active agent, and 7% water or less. See the rejection above over Page by itself.
Page does not teach that the polyol is hexylene glycol or dipropylene glycol.
Perez Nowak et al. (hereafter referred to as Nowak) is drawn to an oil in water emulsion, as of Nowak, title and abstract. Said emulsion may comprise a polyol, as of Nowak, paragraph 0061. Said polyol may be dipropylene glycol, as of Nowak, paragraph 0263.
Nowak differs from the claimed invention because the composition of Nowak appears to have more water than the claimed composition. Also, it is unclear whether the oil in water emulsion of Nowak is the same as the single-phase composition of the instant application.
It would have been prima facie obvious for one of ordinary skill in the art to have used the dipropylene glycol of Nowak as the polyol in the composition of Page. Page is drawn to a composition that comprises a polyol having 3 to 8 carbons, and teaches various ingredients that can be used as said polyol, as of Page, paragraphs 0116-0124. Nowak teaches that dipropylene glycol is a polyol, and this has between 3 and 8 carbon atoms. As such, the skilled artisan would have been motivated to have used the dipropylene glycol of Nowak in the composition of Page to have predictably been a polyol, as desired by Page, with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (dipropylene glycol, as of Nowak) for incorporation into a composition (that of Page), based on its recognized suitability for its intended use (it has the chemical structure of a polyol, which is desired by Page). See MPEP 2144.07.
In the alternative, the skilled artisan would have been motivated to have substituted the dipropylene glycol of Nowak in place of the polyol of Page in order to have predictably formed a cosmetic composition, as taught by Page, with a reasonable expectation of success. The simple substitution of one known ingredient (the dipropylene glycol of Nowak) in place of another (the polyol of Page) in order to achieve predictable results (the formation of a cosmetic composition) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
As to claim 14, Page and Nowak teach all of the required ingredients, though it is unclear if the amounts taught by these references are the same as the claimed amounts. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there is no evidence of the criticality of the concentrations of the ingredients. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a composition comprising isorpropyl myristate and/or dicaprylyl carbonate, a polyol which may be dipropylene glycol, an aliphatic monoalcohol, a hydrophilic active agent, and low amounts of water has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of these ingredients via routine experimentation.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page et al. (US 2019/0336420 A1) in view of Wahler et al. (WO 2021/123170 A1).
Page is drawn to a composition comprising a polar oil which may include isopropyl myristate or dicaprylyl carbonate, a polyol, ethanol, a hydrophilic active agent, and 7% water or less. See the rejection above over Page by itself.
Page does not teach that the polyol is hexylene glycol or dipropylene glycol.
Wahler et al. (hereafter referred to as Wahler) is drawn to a composition comprising a polar oil in an amount of 30-89%, an aliphatic monoalcohol, hexylene glycol, and dipropylene glycol, as of Wahler, abstract. This is useful for delivering a hydrophilic active agent in a manner that there is good penetration and bioavailability of the agent as well as good emollient activity, as of Wahler, page 2, lines 13-17.
Wahler is not anticipatory because Wahler teaches less than 15% by weight water, whereas the instant claims require a more limiting less than 8% by weight of water.
It would have been prima facie obvious for one of ordinary skill in the art to have included the hexylene glycol and/or dipropylene glycol as of Wahler in the composition of Page. Page is drawn to an oily composition intended for cosmetic purposes and used for delivery of a hydrophilic active agent. Wahler is also drawn to an oily cosmetic for delivery of a hydrophilic active agent, and teaches that hexylene glycol, and dipropylene glycol are useful excipient for delivery of said hydrophilic active agent topically. As such, the skilled artisan would have been motivated to have included the hexylene glycol and dipropylene glycol of Wahler in the composition of Page for predictable delivery of a hydrophilic active agent topically in an oily cosmetic with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (e.g. hexylene glycol and dipropylene glycol) for incorporation into a composition (the cosmetic of Wahler), based on its recognized suitability for its intended use (a cosmetic which delivers a hydrophilic active agent). See MPEP 2144.07.
Note Regarding Reference Date: The instant application is a national phase of a PCT application filed on 21 June 2022. This PCT application claims benefit to a foreign priority document published in French filed on 21 June 2021. Wahler was published on 24 June 2021; this is earlier than the national phase filing date but later than the foreign priority date. While there are common inventors between the Wahler document and the instant application, there are individuals who are inventors of Wahler who are not inventors of the instant application; see MPEP 2153.01(a). Wahler was also effectively filed prior to the effective filing date of the instant application and the inventive entity of Wahler is not the same as the inventive entity of the instant application.
As such, the examiner notes the following:
Wahler appears to be prior art under AIA 35 U.S.C. 102(a)(1). However, such a rejection could potentially be overcome by providing a certified translation of the foreign priority document provided that the foreign priority application adequately supports the instantly claimed invention. See 37 C.F.R. 1.55(g)(3)(ii) and MPEP 2152.06(C); also see MPEP 216.01.
Wahler is prior art under AIA 35 U.S.C. 102(a)(2). This is because Wahler was filed earlier than the instant application and does not have the same inventive entity as the instant application. The examiner suggests that applicant review MPEP 2154 and 2155 for more information regarding AIA 35 U.S.C. 102(b)(2)(A-C) exceptions.
Response to Arguments Regarding Obviousness Rejections
Applicant has presented arguments regarding the previously applied rejections, as of applicant’s response on 16 July 2026 (hereafter referred to as applicant’s response). These arguments have been addressed below to the extent that the arguments are applicable to the currently pending rejections.
As an initial matter, applicant has provided various arguments addressing the previously applied anticipation rejection. These arguments were presented on the bottom of page 8 through the top of page 10 of applicant’s response. These arguments appear to be moot in view of the withdrawal of the previously applied anticipation rejection. As such, these arguments have not been addressed substantively.
Regarding the previously applied obviousness rejections, applicant makes the following argument on the second to last paragraph of page 10 of applicant’s response.
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It is unclear to the examiner as to why applicant believes that Page fails to teach this. The composition of Page, abstract, teaches 30% to 89% of a polar oil. This would appear to at least overlap with a composition being mainly oily. Page teaches at least one hydrophilic active ingredient in the abstract. Page teaches a transparent composition in paragraph 0022, and a single-phase composition, as of at least paragraph 0045. Page also appears to teach a less greasy finish in paragraph 0011, which the examiner understands to refer to a less oily finish.
As such, it appears that Page teaches every aim of the invention listed in the above-reproduced paragraph.
Applicant then makes the following arguments, as of page 11 of applicant’s response.
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Regarding the issue of octyldodecanol, the examiner has withdrawn the previously applied anticipation rejection in view of the claim amendment cancelling octyldodecanol. Nevertheless, Page teaches isopropyl myristate and dialkyl carbonates elsewhere in the disclosure of Page; namely, at paragraphs 0070 and 0076. Patents are relevant as prior art for all they contain, and are not limited to their embodiments. See MPEP 2123.
Applicant then asserted that Page does not teach that formulating the polar oil and polyol in the particular recited amount would not solve the “above technical problem.” As best understood by the examiner, the “above technical problem” refers to the issues discussed in applicant’s arguments as of the second to last paragraph on page 10 of applicant’s response, which was reproduced below. This is not persuasive because, as pointed out earlier in this response, it appears that the indicated technical problem has already been solved by Page.
Regarding the combination of Page with Nowak, applicant argues that Nowak teaches only compositions with at least 5% water, which is alleged to be totally contrary to the claimed invention. This is not persuasive. Instant claim 1 requires less than 8% water. A prior art teaching of more than 5% water overlaps with the requirement of less than 8% water. This overlap results in a prima facie case of obviousness; see MPEP 2144.05(I). As such, arguments that Nowak differs from the claimed invention because Nowak teaches a greater quantity of water than what is required by the instant claims are not persuasive.
Regarding the combination of Page with Wahler, applicant argues that Wahler does not cure the deficiencies of Page. This is not persuasive because Page is not deficient for the reasons set forth above. As no additional arguments regarding Wahler have been presented, applicant’s arguments are not persuasive.
Applicant cites various case law in the last paragraph of page 12 of applicant’s response. The relevance of this case law was not explained in applicant’s response and is not clear to the examiner. For example, one of the cited cases was CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338, 68 USPQ2d 1940, 1944 (Fed. Cir. 2003). This case is cited in the MPEP, albeit in section 2164 which relates to rejections for lack of enablement. However, the instant claims were not rejected for lack of enablement; as such, the above-cited case appears unrelated to the issue at hand.
Additionally, one of the cited cases appears to be a non-precedential case decided by the Board of Appeals. A non-precedential case would not serve as a precedent for guiding the examiner’s decision about whether to reject claims as obviousness. As such, it is not clear how the above-cited cases would affect the determination of obviousness.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights