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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 6/3/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/3/2026.
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.
Claim 5 is 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.
Regarding claim 5, the term “Aquosum cream” is not defined in the claims nor the specification. The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). In the instant case, the specification lists the ingredients for Aquosum cream, but does not define the essential characteristics of Aquosum cream. Thus, it is unclear if all of the listed ingredients are required to read on the limitation (see also Table 1 in the instant specification, which only denotes “paraffin in water” with regards to Aquosum cream). Furthermore, even though the specification indicates that Aquosum cream is widely available from manufacturers Johnson and Johnson, Pfiizer, and Bombastus-Werke, a search for products named “Aquosum cream” from these manufacturers yields no results. Thus, it is unclear if Aquosum cream refers to a trade name or a general type of cream. Heiner et al. (DE3720048A1, published 12/29/1988) defines an ointment base, Unguentum emulsificans aquosum, to be “aqueous hydrophilic ointment” [0011]. For purposes of compact prosecution, any aqueous hydrophilic ointment base will be considered to read upon the limitation of “Aquosum cream”.
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.
Claim(s) 1-3 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Prieto (US 2009/0047359 A1, published 2/19/2009, cited on the 6/21/2024 IDS), in view of Gough (2015) and Glozman (US 2024/0269101 A1, effectively filed 7/19/2021), as evidenced by Ngan (2005).
It is noted that “for use in treating dermatitis” in the preamble of claim 1 is a recitation of intended use and does not constitute a functional limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02. In the instant case, the preamble does not add a structural distinction to the claim.
Regarding claims 1 and 2, Prieto teaches a homogenized [0020] ointment for treating dermatitis comprising water, 1.9% olive oil, 5.8% rosemary honey, 0.03% clobetasol (reads on steroid), and white petrolatum (reads on pharmaceutically acceptable cream) by weight of the composition [0013]. The amount of olive oil taught by Prieto falls within the instantly claimed range and renders obvious the instant limitation. Prieto does not explicitly teach date honey in the instantly claimed amounts; however, Gough teaches that date honey is shown to exhibit stronger antibacterial properties than honey, and that date honey could be used in topical clinical applications similar to that of honey [pg. 2]. Thus, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Prieto with that of Gough and substitute rosemary with date honey for its stronger antibacterial properties. Glozman teaches a topical composition for the treatment of skin disorders [0021] comprising triazelaine and an active therapeutic agent [0027]. The composition of Glozman may further comprise a pharmaceutically acceptable cream [0180], olive oil [0185], coconut oil [0185], date honey [0204], and clobetasol [0208]. Glozman teaches that an active substance, such as date honey, may be present in the composition in the range of 0.5% to about 10% by weight [0205]. Thus, it would be obvious to one of ordinary skill to apply the teachings of Glozman to the composition made obvious by Prieto and Gough, and include date honey in the amount taught by Glozman. A prima facie case of obviousness exists where the instantly claimed range overlaps with the range taught in the prior art.
Prieto does not explicitly teach the inclusion of coconut oil in the composition. Glozman teaches that olive oil and coconut oil both have emollient properties [0185]. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, it would be obvious to a skilled artisan to modify the composition of Prieto by adding coconut oil as an additional emollient. Glozman further teaches that functional ingredients such as emollients may be present in the amount of 0.01% to 5% by weight of the composition [0180-0181]. It would be obvious to include coconut oil, an emollient, in the amount that emollients are taught to be suitable in.
Regarding the instantly claimed amount of steroid and clobetasol (instant claims 1, 6-7), Glozman teaches that the active agent of the composition, such as a corticosteroid (i.e. clobetasol) [0207] may comprise from about 0.1% to about 40% by weight [0205]. Glozman teaches that the amount or dosage of a compound for treating a disease will vary depending on the compound, the disease and its severity, and characteristics of the subject to be treated such as age and weight [0205]. Thus, one of ordinary skill would adjust the dosage accordingly and arrive at the instantly claimed dose in the course of routine optimization. Nonetheless, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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).
Regarding claim 3, this claim recites “wherein said dermatitis is atopic dermatitis”. As noted above, the recitation of “for use in treating dermatitis” in claim 1 is a recitation of intended use and does not constitute a functional limitation. The instant recitation of “atopic dermatitis” is merely a narrowing of this intended use and similarly does not constitute a functional limitation. Nonetheless, Glozman teaches a method wherein its composition is used to treat atopic dermatitis [claim 12].
Regarding claim 8, the composition of Prieto comprises water [0013], which reads on pharmaceutically acceptable carriers, excipients, or diluents.
Regarding claim 9, the composition of Prieto comprises salicylic acid. As evidenced by Ngan, salicylic acid exfoliates the upper layer of skin, allowing additional medicines to penetrate more effectively. Thus, salicylic acid reads on the instantly claimed “material adjusting biological tissue permeability” [pg. 1].
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glozman (US 2024/0269101 A1, effectively filed 7/19/2021), evidenced by WebMD, Clobetasol topical (published 10/31/2024); Petersen (US 2010/0047297, published 2/25/2010); and Healthline, Cetearyl Alcohol (published 2/25/2019).
Regarding claim 1 and 6-7, it is reiterated that “for use in treating dermatitis” in the preamble is a recitation of intended use and does not constitute a functional limitation. Glozman teaches a topical composition for the treatment of skin disorders [0021] comprising triazelaine and an active therapeutic agent [0027]. The composition of Glozman may further comprise a pharmaceutically acceptable cream [0180], olive oil [0185], coconut oil [0185], date honey [0204], and clobetasol [0208]. Glozman further teaches that an active substance, such as date honey, may be present in the composition in the range of 0.5% to about 10% by weight [0205]. Glozman also recites that other lipids/oils and moisturizers may be categorized as active substances [0204]. Glozman teaches that olive oil and coconut oil can provide an emollient function [0185], which can be interpreted to read on moisturizers. Furthermore, Glozman teaches that functional ingredients such as emollients may be present in the amount of 0.01% to 5% by weight of the composition [0180-0181]. Accordingly, olive oil and coconut oil may be present in the composition in the range of 0.01% to 5% [0181] or 0.5% to about 10% by weight [0205]. 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). Regarding the concentration of steroid, Glozman teaches that the active agent of the composition, such as a corticosteroid (i.e. clobetasol) [0207] may comprise from about 0.1% to about 40% by weight [0205]. However, differences in concentration generally 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). Glozman teaches that the amount or dosage of a compound for treating a disease will vary depending on the compound, the disease and its severity, and characteristics of the subject to be treated such as age and weight [0205]. Thus, one of ordinary skill would adjust the dosage accordingly and arrive at the instantly claimed dose in the course of routine optimization.
Glozman does not teach a specific embodiment having all the claimed elements. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is... a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed ingredients including olive oil, coconut oil, date honey, a steroid such as clobetasol, and the ingredients comprising a conventional, pharmaceutically acceptable carrier cream from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Regarding claim 2, as recited above, Glozman teaches that the composition may comprise clobetasol. As evidenced by WebMD, clobetasol and clobetasol propionate are synonymous.
Regarding claim 3, this claim recites “wherein said dermatitis is atopic dermatitis”. As noted above, the recitation of “for use in treating dermatitis” in claim 1 is a recitation of intended use and does not constitute a functional limitation. The instant recitation of “atopic dermatitis” is merely a narrowing of this intended use and similarly does not constitute a functional limitation. Nonetheless, Glozman teaches a method wherein its composition is used to treat atopic dermatitis [claim 12].
Regarding claims 4 and 5, Glozman teaches that its composition may be formulated as an emulsion [0080]. The composition of Glozman may comprise of water [0183], petroleum jelly (i.e. petrolatum) [0185], paraffin [0216], cetyl alcohol and stearyl alcohol [0183]. As evidenced by Petersen, the hydrophilic cream known as ungeuntum emulsificans aquosum may be prepared using cetearyl alcohol, paraffin, petrolatum, and water [0072]. Evidentiary source Healthline also states that cetearyl alcohol is a mixture of cetyl alcohol and stearyl alcohol. Thus, the composition of Glozman is interpreted to read on Aquosum cream (see 112(b) rejection of claim 4 above). Since the instant claims state that aquosum cream is an oil in water emulsion, the composition of Glozman also makes obvious an oil in water emulsion.
Regarding claim 8, the composition of Glozman may comprise pharmaceutically acceptable excipients and carriers [0180].
Regarding claim 9, the composition of Glozman may comprise of one or more active agent such as an anti-viral, antifungal, anti-bacterial, and anti-inflammatory [claim 3], thus the use of multiple agents is prima facie obvious.
Conclusion
No claims are allowed.
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/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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