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 .
Status of the Claims
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/29/2026 has been entered.
Claims 2-14, 16-18, and 20 are cancelled.
Claims 1, 15, 19, and 21 are pending and under current examination.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0032] (emphasis added), it is believed that “With reference now to Figure 2, a testing apparatus 100 is shown” should read “With reference now to Figure 1, a testing apparatus 100 is shown”.
In paragraph [0037] (emphasis added), it is believed that “Figure 3 illustrates the results graphically” should read “Figure 2 illustrates the results graphically”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 15, and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites “the permeation enhancer comprising isopropyl jojobate, jojoba alcohol, and a jojoba ester” and claim 15 recites “the jojoba constituents consist of isopropyl jojobate, jojoba ester, and jojoba alcohol”. Isopropyl jojobate is an isopropyl ester derived from jojoba oil, and is thus understood to be a jojoba ester. It is unclear if the recitation of both “isopropyl jojobate” and “jojoba ester” is intended to mean that the claims require the presence of a jojoba ester that is different than isopropyl jojobate or not, and the metes and bounds of the claims are uncertain.
Claim 19 is rejected under 35 U.S.C. 112(b) by virtue of its dependency on indefinite claim 15 and failure to cure the deficiency noted above.
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.
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.
Claims 1, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Arquette et al. (US 6,280,746 A1, patented August 28, 2001; included on IDS submitted 11/24/2020), hereafter “Arquette”, as evidenced by Ahmad et al. (“Prospects and Potential of Green Fuel from some Non Traditional Seed Oils Used as Biodiesel” (2012) in Biodiesel-Feedstocks, Production and Applications, ed. Zhang Fang, https://www.intechopen.com/chapters/41601), hereafter “Ahmad”, and as evidenced by Inolex (“Lexemul® 561 MB” https://www.inolex.com/products/lexemul-561-mb), hereafter “Inolex”.
Arquette teaches dry-feel emollient compositions that have use in pharmaceutical products comprising jojoba oil based esters; the compositions can be produced from combinations of fatty alcohols, isopropyl esters, and wax esters obtained from the oil in the seed of the jojoba plant (see entire document, particularly Abstract and column 3, lines 30-46). Arquette teaches that compositions may be obtained by an alcoholysis reaction between jojoba oil and an alcohol, such as isopropyl alcohol (see particularly abstract, column 3, lines 53-64, and column 4, lines 53-61). As evidenced by Ahmad, alcoholysis is also known as transesterification (pg. 4, paragraph 4).
Arquette teaches that emollients are used to provide vehicles for lipid-solid drugs and can facilitate the transport of such drugs through the skin (column 1, lines 43-50). Jojoba ester compositions are useful in pure or blended forms as a carrier or vehicle for the application of active materials to the skin and leave the skin feeling soft while providing a mildly persistent coating which carries the actives without leaving a wet or oily feel to the skin of the user (column 3, lines 16-30). Arquette teaches that the compositions function as a carrier and vehicle for the delivery of actives such as vitamins and medications (active pharmaceutical ingredients), and that the jojoba ester-containing compositions can be combined with active ingredients (column 1, lines 6-14; column 5, lines 41-66). Arquette exemplifies a composition comprising the active ingredient Vitamin E acetate (see tables of Examples 1 and 2 at column 11).
Arquette suggests that compositions can be used in cream formulations (column 1, lines 49-54; column 9, lines 49-56), and exemplifies a moisturizing composition comprising Lexemul 561 (see Example 1 beginning at column 10, particularly the table at column 11). As evidenced by Inolex, Lexemul 561 is an industry standard emulsifier designed as a primary emulsifier for all types of O/W cream or lotion systems (a cream emulsion carrier base) (pg. 1). Arquette does not require that the carrier base contains further penetration enhancing ingredients nor further active pharmaceutical ingredients, as recited in instant claim 19.
Arquette does not exemplify a composition comprising 1% to 5% by weight of a permeation enhancer comprising the jojoba constituents. However, Arquette teaches that the proportions of jojoba esters should be chosen to provide a desired dry-feel to the composition; this usually requires at least 10% by weight of the carrier material (excluding solvent and actives) in the composition (column 5, line 66-column 6, line 7); this suggests that, with the inclusion of solvents, actives, and other composition components, the jojoba constituents will be present at less than 10% by weight of the total composition. Arquette exemplifies 6.10% of jojoba constituents in Example 1 (3.10% jojoba ester and 3.00% jojoba oil) and 0.3% jojoba wax esters in Example 2 (see tables at column 11), suggesting that amounts of jojoba constituents within this range (consistent with the 1% to 5% recited by the instant claims) are suitable.
From these teachings, a skilled artisan would be motivated to routinely optimize the amount of jojoba constituents in the composition of Arquette in order to achieve a composition with a desired dry-feel. Per MPEP 2144.05 II. A., “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)”.
Independent claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Arquette et al. (US 6,280,746 A1, patented August 28, 2001; included on IDS submitted 11/24/2020), hereafter “Arquette”, as evidenced by Ahmad et al. (“Prospects and Potential of Green Fuel from some Non Traditional Seed Oils Used as Biodiesel” (2012) in Biodiesel-Feedstocks, Production and Applications, ed. Zhang Fang, https://www.intechopen.com/chapters/41601), hereafter “Ahmad”, and as evidenced by Inolex (“Lexemul® 561 MB” https://www.inolex.com/products/lexemul-561-mb), hereafter “Inolex”, in view of Verbiscar (US 6,858,232 B2, patented February 22nd, 2005; included on IDS submitted 11/24/2020).
Arquette teaches dry-feel emollient compositions that have use in pharmaceutical products comprising jojoba oil based esters; the compositions can be produced from combinations of fatty alcohols, isopropyl esters, and wax esters obtained from the oil in the seed of the jojoba plant (see entire document, particularly Abstract and column 3, lines 30-46). Arquette teaches that compositions may be obtained by an alcoholysis reaction between jojoba oil and an alcohol, such as isopropyl alcohol (see particularly abstract, column 3, lines 53-64, and column 4, lines 53-61). As evidenced by Ahmad, alcoholysis is also known as transesterification (pg. 4, paragraph 4).
Arquette teaches that emollients are used to provide vehicles for lipid-solid drugs and can facilitate the transport of such drugs through the skin (column 1, lines 43-50). Jojoba ester compositions are useful in pure or blended forms as a carrier or vehicle for the application of active materials to the skin and leave the skin feeling soft while providing a mildly persistent coating which carries the actives without leaving a wet or oily feel to the skin of the user (column 3, lines 16-30). Arquette teaches that the compositions function as a carrier and vehicle for the delivery of actives such as vitamins and medications (active pharmaceutical ingredients), and that the jojoba ester-containing compositions can be combined with active ingredients (column 1, lines 6-14; column 5, lines 41-66).
Arquette suggests that compositions can be used in cream formulations (column 1, lines 49-54; column 9, lines 49-56), and exemplifies a moisturizing composition comprising Lexemul 561 (see Example 1 beginning at column 10, particularly the table at column 11). As evidenced by Inolex, Lexemul 561 is an industry standard emulsifier designed as a primary emulsifier for all types of O/W cream or lotion systems (an excipient cream emulsion base) (pg. 1).
Arquette does not exemplify a composition comprising 1% to 5% by weight of a permeation enhancer comprising the jojoba constituents. However, Arquette teaches that the proportions of jojoba esters should be chosen to provide a desired dry-feel to the composition; this usually requires at least 10% by weight of the carrier material (excluding solvent and actives) in the composition (column 5, line 66-column 6, line 7); this suggests that, with the inclusion of solvents, actives, and other composition components, the jojoba constituents will be present at less than 10% by weight of the total composition. Arquette exemplifies 6.10% of jojoba constituents in Example 1 (3.10% jojoba ester and 3.00% jojoba oil) and 0.3% jojoba wax esters in Example 2 (see tables at column 11), suggesting that amounts of jojoba constituents within this range (consistent with the 1% to 5% recited by the instant claims) are suitable.
From these teachings, a skilled artisan would be motivated to routinely optimize the amount of jojoba constituents in the composition of Arquette in order to achieve a composition with a desired dry-feel. Per MPEP 2144.05 II. A., “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)”.
Arquette does not teach that the active pharmaceutical ingredient is selected from the group consisting of a non-steroidal anti-inflammatory drug, a peptide, a hormone, a nucleic acid, an antibiotic, a vaccine preparation, and an immunogenic preparation.
Verbiscar teaches that jojoba alcohol is readily absorbed by human skin where it relieves irritation and inhibits formation of lesions caused by viruses; jojoba alcohol is a carrier and transdermal delivery system for pharmacologically active ingredients including those for the relief of pain (see entire document, particularly abstract). Verbiscar exemplifies formulations of the nonsteroidal anti-inflammatory drugs ibuprofen and ketoprofen in jojoba alcohol that successfully relieved pain when applied topically to skin surfaces over the site of pain (column 10, lines 38-54 and Example 4 at column 12). Formulations including testosterone and prostaglandin E1 hormones were also transdermally delivered (column 11, lines 8-28).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the compositions of Arquette to include active pharmaceutical ingredients such as non-steroidal anti-inflammatory drugs and hormones suggested by Verbiscar. One of ordinary skill in the art would have been motivated to do so to with a reasonable expectation of success to achieve a transdermal formulation that achieves a desired therapeutic effect, such as relieving pain or providing hormone replacement therapy, and which improves upon other modes of administration, such as by avoiding gastrointestinal side effects, as suggested by Verbiscar (column 10, lines 38-54 and column 11, lines 8-28). There is a reasonable expectation of success as the compositions of Arquette comprise alcohols derived from jojoba oil and are used for the delivery of active materials, including medications, to the skin.
Response to Arguments
Applicant’s arguments filed 07/29/2026 have been fully considered.
Regarding the rejection of claim 1 under 35 USC § 112(a), Applicant argues that the amended claim recites only “an active pharmaceutical ingredient” which should cure the rejection.
In response, the Examiner notes that the rejection of claim 1 under 35 USC § 112(a) has been withdrawn in view of the claim amendments.
Regarding the rejection of claims 15 and 19 under 35 USC § 112(b), Applicant argues that the amendment to claim 15 clarifies the scope of the claim.
In response, the Examiner notes that the previous rejections of claims 15 and 19 under 35 USC § 112(b) have been withdrawn in view of the claim amendments. However, as detailed above in the newly applied rejections under 35 U.S.C. 112(b), claims 1, 15, and 19 are found to be indefinite due to the recitation of both “isopropyl jojobate” and a “jojoba ester” in claims 1 and 15.
Regarding the claim rejections under 35 USC § 103, Applicant argues that the cited prior art of Sharma does not teach the use of jojoba esters or jojoba alcohols, but rather jojoba oil, and the resultant substances of transesterification of jojoba oil are not contemplated by Sharma; Sharma further does not teach use of isopropyl jojobate. Applicant argues that in teaching 5 wt.% to 10 wt.% of vegetable oil rather than jojoba ester, jojoba alcohol, and isopropyl jojobate, Sharma does not teach overlapping amount of the claimed constituents. Applicant further argues that the combination of Sharma with Aracil Mira does not support a prima facie case of obviousness as esters resulting from transesterification of jojoba oil are taught to be used as biodiesel or biodegradable products.
Applicant’s arguments with respect to Sharma and Aracil Mira have been considered but are moot because the new ground of rejection applied above does not rely on Sharma or Aracil Mira for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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