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
Claims 1-19 are pending and under current examination.
Claim Objections
Claims 1-15 and 17-19 are objected to because of the following informalities:
Claim 1 recites “glycol, or glycol ether, or glycol ether ester”. This is grammatically incorrect and should be amended to read “glycol, glycol ether, or glycol ether ester”.
Claims 2-15 and 17-19 are objected to because the dependent claims lack the article “The” at the beginning of each claim. See MPEP 608.01(n)(IV).
Appropriate correction is required.
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.
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 1-19 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 weight percentages of different components of the drug delivery solution but do not state to which weight the weight percentages are relative. This renders the claim indefinite because it is impossible to discern the weight that each percentage is intended to be relative to.
Claim 5 recites a weight percentage of component c, but does not state to which weight the weight percentage is relative. This renders the claim indefinite because it is impossible to discern which value the percentage is intended to be relative to.
Claims 7 and 8 recite a weight percentage of component d, but does not state to which weight the weight percentage is relative. This renders the claim indefinite because it is impossible to discern which value the percentage is intended to be relative to.
Claim 13 recites weight percentages of different components of the drug delivery solution but do not state to which weight the weight percentages are relative. This renders the claim indefinite because it is impossible to discern the weight that each percentage is intended to be relative to.
Claim 13 contains the trademark/trade names Capryol 90, Kolliphor HS15, and Tween 80. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe propylene glycol esters of fatty acids, polyethylene glycol esters of fatty acids, and polyethylene glycol esters of sorbitan fatty acid monoesters and, accordingly, the identification/description is indefinite.
Claim 16 recites “a concentration of about 40% to about 80%”. This renders the claim indefinite because there are no units provided for the concentration (i.e. mass or volume) and no value provided to which the concentration is relative.
Claim 18 recites a weight percentage of component e, but does not state to which weight the weight percentage is relative. This renders the claim indefinite because it is impossible to discern which value the percentage is intended to be relative to.
Claim 19 recites weight percentages of components b and c, but does not state to which weight the weight percentage is relative. This renders the claim indefinite because it is impossible to discern which value the percentage is intended to be relative to.
Regarding claims 2-4, 6, 9-12, 14, 15, and 17, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Garti (U.S. Patent Application No. 2021/0137829, publication date: 5/13/2021) in view of Bergamante et. al. (Drug Delivery, pg. 427-432, publication year: 2007), as evidenced by Ahmad et. al. (Colloids and Surfaces A: Physicochemical and Engineering Aspects, pg. 68-77, publication year: 2014), Ali (American Pharmaceutical Review, available 2/25/2019), and Kassem et. al. (Energy Reports, pg. 221-230, publication year: 2019).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 6, Garti teaches topical formulations for dermal delivery of an active agent [0022]. The topical formulation comprises an oily phase and a gelled aqueous phase, the oily phase being in the form of oily nano-domains droplets that are dispersed in the gelled aqueous continuous phase [0023-24]. The active agent may be diclofenac sodium [0091] and may be present between 1 and 6 wt.% [0092]. The formulation includes at least two penetrating promoters, which may include 2-(2-ethyoxyethoxy)ethanol (transcutol) [0084]. The total amount of penetrating promoter is between about 2 and 10 wt.% [0082]. The formulation may also include at least two hydrophilic surfactants such as ethoxylated monoglycerol esters like PEG, 5, 6, 7, 20, 40-caprylic/capric, lauric, and oleic glycerides [0057] or ethoxylated hydroxyl stearic acid (Solutol HS15) [0060]. The first hydrophilic surfactants may also be chosen from polysorbate 40, 60, or 80 [0061] and may be present in an amount between 1.75 and 8.0 wt.% [0064]. The total amount of hydrophilic surfactants in the formulation is between 2 and 12 wt. % [0064]. The formulation may also contain a co-surfactant which may be present in between 0.4 and 2 wt.% [0075].
Regarding claim 2, Garti teaches that the formulation may also contain a co-surfactant which may be present in between 0.4 and 2 wt.% [0075].
Regarding claim 3, Garti teaches that the formulation may also include at least two hydrophilic surfactants such as Solutol HS15 [0060]. Ali teaches that Solutol HS15, also known as Kolliphor HS 15, has an HLB of about 16 (Introduction, first paragraph).
Regarding claim 4, Garti teaches that the first hydrophilic surfactants may also be chosen from polysorbate 40, 60, or 80 (Tween 80) [0060]. Kassem teaches that Tween 80 has an HLB value of 15 (pg. 222, Introduction).
Regarding claim 5, Garti teaches that the formulation may also contain a co-surfactant which may be present in between 0.4 and 2 wt.%. The co-surfactant, together with the surfactants, contributes to lowering of the interfacial tension between the oily phase and the aqueous phase to almost zero allowing for the formation of thermodynamically stable oily domains [0075].
Regarding claim 7, Garti teaches that the total amount of penetrating promoter is between about 2 and 10 wt.% [0082]. The formulation may also include at least two hydrophilic surfactants such as ethoxylated monoglycerol esters like PEG, 5, 6, 7, 20, 40-caprylic/capric, lauric, and oleic glycerides [0057]. The first hydrophilic surfactants may also be chosen from polysorbate 40, 60, or 80 [0061] and may be present in an amount between 1.75 and 8.0 wt.% [0064]. The total amount of hydrophilic surfactants in the formulation is between 2 and 12 wt. % [0064].
Regarding claim 8, Garti teaches that the formulation may include Solutol HS15 [0060]. Ali teaches that Solutol HS15, also known as Kolliphor HS 15, is composed of polyethylene oxide esters of 12-hydroxystearic acid with about 30-35% of free polyethylene glycol (Introduction, first and second paragraph).
Regarding claim 9, Garti teaches that the first hydrophilic surfactants may also be chosen from polysorbate 20, 40, 60, or 80 [0060].
Regarding claim 10, Garti teaches that the formulations are typically transparent [0104].
Regarding claim 11, Garti teaches that the oily domains have a size of between about 5 and 150nm [0027]. The size distribution may be measured by dynamic light scattering analysis [0190 and Figs. 14A and 14B].
Regarding claim 12, Garti teaches that the structures of the formulation are formed spontaneously [0027].
Regarding claim 13, Garti teaches topical formulations for dermal delivery of an active agent [0022]. The topical formulation comprises an oily phase and a gelled aqueous phase, the oily phase being in the form of oily nano-domains droplets that are dispersed in the gelled aqueous continuous phase [0023-24]. The active agent may be diclofenac sodium [0091] and may be present between 1 and 6 wt.% [0092]. The formulation includes at least two penetrating promoters, which may include 2-(2-ethyoxyethoxy)ethanol (transcutol) [0084]. The total amount of penetrating promoter is between about 2 and 10 wt.% [0082]. The formulation may also include at least two hydrophilic surfactants such as Solutol HS15 [0060]. The first hydrophilic surfactants may also be chosen from polysorbate 40, 60, or 80 [0061] and may be present in an amount between 1.75 and 8.0 wt.% [0064]. The total amount of hydrophilic surfactants in the formulation is between 2 and 12 wt. % [0064]. The formulation may also contain a co-surfactant which may be present in between 0.4 and 2 wt.% [0075].
Regarding claim 14, Garti teaches that the formulation may be included in a kit that contains the formulation in a dosing form [0170]. The dosing form includes a container for holding the formulation [0171] and can be in any form known in the art, including a spray, roll-on, swabs, or pads, enabling application of the formulation to a desired skin area [0172].
Regarding claim 15, Garti teaches that the formulation may be used to treat an inflammatory disease, mild to moderate pain, musculoskeletal disorders, or signs and symptoms of osteoarthritis and joint stiffness, as well as inflammatory skin conditions [0169].
Regarding claim 16, Garti teaches topical formulations for dermal delivery of an active agent [0022]. The topical formulation comprises an oily phase and a gelled aqueous phase, the oily phase being in the form of oily nano-domains droplets that are dispersed in the gelled aqueous continuous phase [0023-24]. The formulation comprises between about 50 and 90 wt.% of the diluent [0101]. The aqueous phase is gelled by a gellant such as xanthan gum [0093-0094].
Regarding claim 17, Garti teaches that the topical formulations may include penetrating promoters [0081] including oleyl alcohol [0084].
Regarding claim 18, Garti teaches that the formulations may include isopropanol and propylene glycol [0068] as polar solvents. The total amount of solvents in the formulation is between about 2.5 and 25 wt.% [0073]. The formulation may also include at least two hydrophilic surfactants. The first hydrophilic surfactants may also be chosen from polysorbate 20, 40, 60, or 80 [0061].
Regarding claim 19, Garti teaches that the topical formulations may include penetrating promoters [0081] including oleyl alcohol [0084]. The total amount of penetrating promoters is between about 2 and about 10 wt.% [0082]. Oleyl alcohol may also be present as the oily phase in an amount between 0.5 and 3 wt.% [0056]. The gellant may be present in an amount between about 0.75 and 3.5 wt.% [0099].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 2, 5, 6, and 13 Garti does not teach the inclusion of a propylene glycol ester of fatty acids. However, this deficiency is cured by Bergamante.
Bergamante teaches that propylene glycol monocaprylate (Capryol 90) may be used as a cosurfactant in a microemulsion preparation for topical drug application (pg. 428, Microemulsion Preparation). Ahmad teaches that propylene glycol monocaprylate has an HLB value of 6.0 (pg. 71, Table 1).
Regarding claims 5 and 13, Garti does not teach a weight percentage of a propylene glycol ester of fatty acids with the range embraced by the instant claims.
Bergamante teaches that Capryol 90 may be present at 9.5% by weight in a microemulsion preparation for topical drug delivery (pg. 428, Table 1).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 2, 5, 6, the idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional cosurfactants used in microemulsions for topical drug application. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Regarding the weight percentage of propylene glycol esters as specified in claims 5 and 13, MPEP 2144.05 states:
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).
Furthermore, Garti teaches that the cosurfactant works together with the surfactants to create thermodynamically stably oily domains [0075] and Bergamante teaches that Capryol 90 may be present at 9.5% by weight in a microemulsion preparation for topical drug delivery (pg. 428, Table 1). The Applicants' specification provides no evidence that the selected weight percentage in claim 5 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the synergistic effect of co-surfactant and surfactants on the thermodynamic stability of the oily domains, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the weight percentage to lie within the range embraced by the instant claims. One of ordinary skill in the art would have been motivated to change the weight percentage as this could be expected to be advantageous for optimizing thermodynamic stability of the oily domains with respect to the chosen surfactants.
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614