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 .
Withdrawn Objections/Rejections
The objections to claims 15 and 19 are withdrawn as the amended claims have addressed the informalities.
The rejection of claim 1 under 35 USC § 112(b) is withdrawn in view of the claim amendments.
The previous rejections of claims 1, 15, and 19 under 35 USC § 103 are withdrawn in view of the claim amendments.
Claim Status
Applicants' amendments and arguments filed 11/06/2025 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 2-14, 16-18, and 20 are cancelled.
Claim 21 is newly added.
Claims 1, 15, 19, and 21 are pending and under current examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/06/2025 has been considered by the Examiner.
Claim Objections
Claim 21 is objected to because of the following informalities: for consistency in the claim numbering a period should follow the claim number “21”. It is further suggested that “a nucleic acids, an antibiotics, a vaccine preparations” in lines 6-7 should read “ a nucleic acid, an antibiotic, a vaccine preparation” (that is, nucleic acid, antibiotic, and vaccine preparation should be recited in the singular).
Appropriate correction is required.
Rejections Maintained
Claim Rejections - 35 USC § 112(a)-Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 1 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
The instant application does not sufficiently describe the invention as it relates to “an active pharmaceutical ingredient having an increased transdermal absorption in the presence of the jojoba ester”.
In Regents of the University of California v. Eli Lilly & Co. 43 USPQ2d 1398, the court stated:
A written description of an invention involving a chemical genus, like a description of a chemical species, “requires a precise definition, such as by structure, formula, [or] chemical name,” of the claimed subject matter sufficient to distinguish it from other materials. Fiers , 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe , 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . .”).
Further, MPEP 2163 requires a known or disclosed correlation between function and structure to show that the inventor was in possession of the claimed invention. Per MPEP 2163 (emphasis added) “An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that inventor was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613 (quoting the Written Description Guidelines, 66 Fed. Reg. at 1106, n. 49, stating that "if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function".). "Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function." Id.”
Here, although the claims recite some functional characteristics, i.e., an active pharmaceutical having an increased transdermal absorption in the presence of the jojoba ester, the claim lacks written description because there is no disclosure of a correlation between function and structure of the compounds in the specification with increased transdermal absorption in the presence of jojoba ester, nor evidence of strong correlation established in the art. In addition, based on the functional characteristics recited by the instant claims, the instant claims would include compounds discovered at a later date. Given the potentially limitless scope of the compounds encompassed by the instant claims, applicant cannot reasonably be said to have been in possession of each and every compound encompassed by the generic claims, each and every active pharmaceutical having an increased transdermal absorption in the presence of the jojoba ester. Accordingly, the present specification fails to provide adequate written description for the genus of claims and does not reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the entire scope of the claimed invention.
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 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 15 recites “a permeation enhancer including jojoba constituents from 1% to 5% of the composition by weight”. This renders the scope of the claim indefinite as it is unclear if the claim requires 1) that the permeation enhancer is in an amount from 1% to 5% by weight of the composition or 2) the jojoba constituents are in an amount from 1% to 5% by weight of the composition (and thus the total amount of permeation enhancer is not limited). For purposes of examination and applying prior art, this limitation with be interpreted as referring to % weight of jojoba constituents in the composition.
Claim 19 is rejected under 35 U.S.C. 112(b) by virtue of its dependency on indefinite claim 15.
New Rejections Necessitated by Claim Amendments
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, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 5,229,130, patented July 20, 1993; included on IDS submitted 11/24/2020), hereafter “Sharma” in view of Aracil Mira et al. (WO 2014/140392 A1, published September 18, 2014), hereafter “Aracil Mira”.
Sharma teaches methods and compositions which increase the permeability of skin to transdermally administered pharmacologically active agents which are formulated with one or more vegetable oils as skin permeation enhancers (abstract). Compositions comprise a therapeutically effective amount of at least one drug and a permeation-enhancing amount of a vegetable oil composition (column 2, lines 40-45). The vegetable oil composition comprises at least one vegetable oil selected from the group including jojoba oil (column 2, lines 55-64; column 3, lines 9-15). As evidenced by Aracil Mira, jojoba oil is a mixture of linear esters composed mainly of alcohols and carboxylic acids (pg. 2, “State of the Art”, paragraph 1). The pharmacologically active agents of Sharma include antibiotics and hormones (column 4, lines 6-30), consistent with those recited in instant claim 21.
Sharma teaches that the relative amounts of components in the compositions can vary depending on factors such as the depth of cutaneous penetration desired and the strength of the enhancer; it is preferred that the compositions contain on the order of from about 5 wt.% to 10 wt.% vegetable oil (column 5, lines 26-49). Thus, Sharma teaches an amount of permeation enhancing oil overlapping the range of the instant claims and that the amount of oil can be adjusted depending on factors such as depth of penetration desired, indicating that the amount of jojoba oil could be routinely optimized to achieve the desired penetration effects. Per MPEP 2144.05, “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)”. Further, 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)”.
Sharma further teaches that the compositions can be applied as an ointment, gel, cream, or the like (column 5, lines 50-57), interpreted to mean that an excipient cream emulsion base/suitable cream emulsion carrier base is present in the cream composition. The compositions of Sharma do not require the inclusion of further penetration enhancing ingredients nor further active ingredients, as recited in instant claim 19. Sharma teaches that vegetable oils, including jojoba oil, can enhance the transdermal flux of a drug through the skin (column 2, lines 55-64) and that application of the composition as a cream can be used to apply the composition to a defined surface of the skin for a period of time sufficient to provide the desired blood level of drug for the desired period of time (column 5, lines 50-57). Formulating the composition of Sharma as a cream would predictably result in a composition that can be applied to the skin for a period of time sufficient to provide the desired blood level of the drug.
Sharma does not teach that the jojoba ester is from transesterified jojoba oil (instant claim 1), that jojoba constituents consist of jojoba ester and jojoba alcohol from transesterified jojoba oil (instant claim 15), or that the permeation enhancer comprises a jojoba ester and jojoba alcohol from transesterified jojoba oil (instant claim 21).
Aracil Mira teaches the transesterification of jojoba oil resulting in mixtures of fatty alcohols in oily liquid form and monoalkylic esters as biproducts; the transesterified oil can be used for the transdermal administration of pharmacological agents (abstract). Transesterification results in jojoba alcohol blends that are easily absorbed by human skin and which, unlike jojoba oil, do not require a surfactant to facilitate transdermal penetration (pg. 3, paragraph 3).
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 substitute the jojoba oil in the composition of Sharma with the transesterified jojoba oil (jojoba alcohols and esters) suggested by Aracil Mira. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to employ a jojoba oil form known for use in the transdermal delivery of pharmacological agents that is easily absorbed by human skin and which offers improved facilitation of transdermal penetration without the use of ingredients such as surfactants as compared to non-transesterified jojoba oil, as taught by Aracil Mira. There is a reasonable expectation of success as the compositions of Sharma are taught to increase the permeability of skin to transdermally administered pharmacologically active agents and comprise jojoba oil.
Response to Arguments
Applicant’s arguments filed 11/06/2025 have been fully considered.
Regarding the rejection of claim 1 under 35 USC § 112(a), Applicant argues that it is not a requirement for patentability to specify every API for which the present invention might be suitable; Applicant was clearly in possession of an invention suitable for a number of API and limits the universe of APIs to those for which permeation is increased for the remainder of the composition as supported by the specification as filed (citing to paragraphs [0002], [0017], and [0033]-[0038]).
These arguments are unpersuasive. While the specification exemplifies certain APIs, showing Applicant was in possession of “a number of API”, the specification does not support that Applicant, at the time the application was filed, had possession of the entire scope of compounds encompassed by the claim language of “active pharmaceutical ingredient having an increased transdermal absorption in the presence of the jojoba ester”. The instant claims recite a function of the API (“having an increased transdermal absorption in the presences of the jojoba ester”), but, per MPEP 2163, functional characteristics must be coupled with a known or disclosed correlation between function and structure to show that the inventor was in possession of the claimed invention. There is no disclosure of such a correlation in the specification, nor evidence of strong correlation established in the art; thus, the Examiner maintains that Applicant cannot reasonably be said to have been in possession of the potentially limitless number of each and every compound encompassed by the generic claim.
Regarding the claim rejections under 35 USC § 103, Applicant argues that neither Sharma nor Verbiscar teaches the amended claim limitations regarding transesterification of jojoba oil. Applicant further argues that claim 15 remains in closed format and that the cited combination does not teach any embodiment limited to the ingredients specified in claim 15.
Applicant’s arguments that neither Sharma nor Verbiscar teach transesterification of jojoba oil are considered moot in view of the newly presented rejections above which address the limitations of the amended claims.
Regarding the closed language of claim 15, the Examiner submits that the teachings of the modified Sharma set forth above are consistent with the composition of the instant claim. The combined teachings of the prior art arrive at a cream formulation containing a permeation enhancer, including the recited jojoba constituents, and an active pharmaceutical ingredient. The composition of the modified Sharma does not require any further ingredients outside of those instantly recited. Further, the claim does not limit the components of the “suitable cream emulsion carrier base” such that the Examiner can conclude that the teachings of the modified Sharma are inconsistent with the composition of the instant claim.
Conclusion
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 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