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 . Claims included in prosecution are claims 1-2, 4, 6-10, 13-14, 16-19, and 32-33.
Response to Restriction Requirement
Applicant’s election without traverse of Group I, claims 1-2, 4, 6-10, 13-14, 16-19, and 32-33, in the reply filed on 7/1/26 is acknowledged.
Claims 20-22, 25, 27, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
1. Claims 4, 6, 9, 16-18, and 32-33 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
For example, in the present instance, claim 4 recites the broad recitation “wherein the emollient comprises two or more of: mineral oil, petrolatum, and paraffin”, and the claim also recites “preferably wherein the emollient is petrolatum and paraffin” which is the narrower statement of the range/limitation.
Claims 16-18 also contain similar recitations of the term “preferably”.
Further, claim 9 recites the broad recitation “wherein the emulsifier comprises glyceryl stearate, and polyglyceryl-6-stearate”, and the claim also recites “and optionally further comprises ceteareth-20, polyglyceryl-6-stearate, and polyglyceryl-6 behenate” which is the narrower statement of the range/limitation.
Claims 6 and 32 also contain similar recitations of the term “optionally”.
In the instant case, optionally is used in the same context, and with the same meaning, as the term "preferably."
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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.
1. Claim(s) 1-2, 4, 6-10, 13-14, 16, 19, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt et al. (US 2003/0050589, Mar. 13, 2003) (hereinafter McDevitt) in view of LaRosa et al. (US 2021/0015836, Jan. 21, 2021) (hereinafter LaRosa), Cifter et al. (EP 2514409, Oct. 24, 2012) (hereinafter Cifter), and Van Der Meer (Lotion Making 101, Jun. 16 , 2018) (hereinafter Van Der Meer).
McDevitt discloses an appendage sleeve, can be used for wounds, cuts, and blisters, as well as joint related ailments, such as arthritis and carpal tunnel syndrome. Various additives can be applied to the sleeve to aid for therapeutic purposes (Abstract). An appendage sleeve is generally formed from a base web material that is shaped into a sleeve (¶ [0024]). Any material commonly used in the art to manufacture cloths can be used as the base web (¶ [0025]). Suitable additives include topical analgesics (¶ [0028]). The additives may be in the form of lotions (¶ [0029]). The appendage sleeve of the typically includes an elastic component for providing the sleeve with form-fitting properties. For instance, it has been discovered that by forming an appendage sleeve with an elastic component, the resulting sleeve can snuggly fit so that the sleeve can more effectively remain thereon (¶ [0043]). The additives may be coated onto the sleeve (¶ [0123]).
McDevitt differs from the instant claims insofar as not disclosing the use of a water-in-oil emulsion composition as instantly claimed.
However, LaRosa discloses a topical analgesic composition (Abstract). The composition includes external analgesic agent, solvent, emulsifier, polymeric binder, solubility oil, antioxidant, preservative, herbal active ingredient, microcirculation stimulant, pH adjusting agent and at least one of a cannabinoid, terpene, and flavonoid (¶ [0003]). The composition may be beneficial in preventing, treating, managing, and/or ameliorating a variety of minor aches and pains of muscles. Specifically, it is beneficial in preventing, treating, managing, and/or ameliorating at least one of: sore muscles, muscle fatigue, muscle stiffness, arthritis, muscle strains, cramps, and sprains (¶ [0012]). Emulsifiers form or promote and emulsion (¶ [0022]). Emollients are lubricating ingredients that soften and smooth skin where suitable emollients include mineral oils and petrolatum (satisfies claim 4) (¶ [0026]). Topical formulation includes a formulation that can be applied to a skin surface. Topical formulations may, for example, be used to confer therapeutic benefit to a patient or pain relief to a consumer. Topical formulations can be used for both topical and transdermal administration of substances. The topical formulations can be configured and formulated to exist in various dosage forms, such as a lotion (¶ [0047]). Suitable solvents include at least one of ordinary skill in the art water and glycerin (¶ [0121]). The solvent is present in an amount of 88 ±5 wt.% (¶ [0124]). Suitable external analgesic includes menthol (¶ [0125]). This may be included in an amount of 2.5 wt.% (¶ [0126]). Suitable emulsifiers include cetyl alcohol, cetearyl alcohol, stearyl alcohol, glyceryl stearate, polyglyceryl-6 laurate, ceteareth-20, or any combination thereof (¶ [0177]). Suitable preservatives include methylparaben, propylparaben, benzyl alcohol, phenoxyethanol, ethylhexylglycerin, sodium benzoate, or any combination thereof which may be included in an amount of 0.1 ±0.02 wt.% (satisfies claim 10) (¶ [0202-0203]).
McDevitt discloses that the sleeve may be coated in order to yield a therapeutic effect. Therefore, it is reasonable to conclude that the sleeve is coated on the inner surface. Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have coated the inner surface of the sleeve of McDevitt with the lotion of LaRosa since the sleeve of McDevitt may be coated with a topical analgesic in the form of a lotion and the composition of LaRosa is a topical analgesic which may be in the form a lotion and may be used for both topical and transdermal administration of substances; and motivated by the desire to prevent, treat, manage, and/or ameliorate a variety of minor aches and pains of muscles and arthritis as taught by LaRosa.
The combined teachings of McDevitt and LaRosa differ from the instant claims insofar as not disclosing wherein the composition/sleeve comprises dimethyl sulfone or menthol in amounts such as 0.5 to 1.5 wt.%.
However, Cifter discloses a topical pharmaceutical composition comprising methylsulfonylmethane used for the treatment of pain and inflammatory symptoms (Abstract). Methylsulfonylmethane (MSM) is also known as dimethyl sulfone (¶ [0007]). MSM is commonly used for osteoarthritis (¶ [0007]). The composition further comprises menthol in an amount of 0.1 to 15 wt.% (¶ [0030]). The composition preferably contains MSM in an amount of 1 to 20 wt. (¶ [0038]). Menthol used in the formulation gives anesthetic effect (¶ [0044]). The topical compositions may take the form of lotion (¶ [0050]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the sleeve/composition of McDevitt in view of LaRosa to comprise MSM in an amount of 1-20 wt.% since it is a known active to treat arthritis and effective amount thereof which is an objective of McDevitt in view of LaRosa. It would have also been obvious for one of ordinary skill in the art to adjust the amount of menthol in the sleeve/composition of McDevitt in view of LaRosa to 0.1 to 15 wt.% since such amounts are known to have an anesthetic effect. One of ordinary skill in the art would have had a reasonable expectation of success since the sleeve of McDevitt in view of LaRosa may be coated with a topical analgesic in the form of a lotion and the composition of Cifter is a topical analgesic which may be in the form of a lotion and may be combined with menthol. The combined teachings of McDevitt, LaRosa, and Cifter differ from the instant claims insofar as not disclosing wherein the emulsifiers are used in an amount of 5-10 wt.% or disclosing wherein water is used in an amount of 60-75 wt.%.
However, Van Der Meer discloses that by default, a lotion will be an O/W emulsion. The oil phase will be around 10% and the water phase will be around 70-80% (Pg. 1). Further, emulsifiers are a key ingredient and are used at around 3-8 wt.% (Pg. 1).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have to have formulated the sleeve/composition of McDevitt in view of LaRosa and Cifter to comprise emulsifiers in an amount of 3-8 wt.% when the composition is in the form of a lotion since this is the effective amount of emulsifier when formulating a lotion as taught by Van Der Meer.
Regarding claim 1 reciting coating with an oil-in-water emulsion, as discussed above, McDevitt discloses wherein the sleeve may be coated with a lotion and Van Der Meer teaches that by default a lotion will be an O/W emulsion. As such, coating the garment with an oil-in-water emulsion would have been obvious.
Regarding the amount of emollient recited in instant claims 1 and 2, 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). As discussed above, emollients are lubricating ingredients that soften and smooth skin, which makes amounts thereof a result effective variable, since amounts directly impact the lubricating or softening/smoothing effect. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of emollient to yield the desired lubrication or softening/smoothing effect.
Regarding the amount of humectant and water recited in instant claims 1, 13-14, 16, and 32, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, McDevitt in view of LaRosa disclose wherein the solvent comprises at least one of water and glycerin and the amount of solvent is 88 ±5 wt.%. Accordingly, it would have been obvious to select glycerin and water as the solvent in a total amount of 88% ±5 wt.%. Further, where Van Der Meer teaches that it was known to include water in amounts ranging from 70-80 wt.% in lotion emulsions, it would have been well within the relative skills of one of ordinary skill in the art to adjust the water content to 70-80 wt.%, with the rest being glycerin, overlapping the claimed range. Therefore, water would be included in an amount of 70-80 wt.% and glycerin would be included in an amount of 8 to 18 wt.%. Accordingly, because the amounts recited in the instant claims overlap with the amounts disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer, the amounts disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer meet the instantly recited limitations.
Regarding the amounts of cooling agent recited in instant claim 1, 13-14, and 32, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, McDevitt in view of LaRosa, Cifter, and Van Der Meer disclose wherein menthol is included in an amount of 0.1 to 15 wt.%. Accordingly, because the amounts recited in the instant claims lie inside the range disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer, the range disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer meets the instantly recited limitations.
Regarding the amounts of dimethyl sulfone recited in recited in instant claim 1, 13-14, and 32, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, McDevitt in view of LaRosa, Cifter, and Van Der Meer disclose wherein dimethyl sulfone is included in an amount of 1-20 wt.%. Accordingly, because the amounts recited in the instant claims overlap with and/or lie inside the range disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer, the range disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer meets the instantly recited limitations.
Regarding the amounts of emulsifier recited in recited in instant claim 1 and 32, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, McDevitt in view of LaRosa, Cifter, and Van Der Meer disclose wherein emulsifiers are included in lotions in an amount of 3-8 wt.% Accordingly, because the amounts recited in the instant claims overlap with the range disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer, the range disclosed by McDevitt in view of LaRosa, Cifter, and Van Der Meer meets the instantly recited limitations.
Regarding claim 19 reciting composition stability, a rejection can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic. See MPEP 2112(II) and (III). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). Further, if the composition is physically the same, it must have the same properties. See MPEP 2112.01(II). The sleeve/composition of McDevitt in view of LaRosa, Cifter, and Van Der Meer are substantially the same as the garment and composition of the instant claims where they comprise a sleeve worn by a user may be coated by a topical analgesic which may be a lotion (i.e., an oil-in-water emulsion) and a topical analgesic composition which may be a lotion comprising substantially the same components as instantly claimed. As such, it would be reasonable for one of ordinary skill in the art to conclude that the composition of the prior art would have the substantially the same stability with respect to microbiological burden as instantly claimed.
Accordingly, the combined teachings of McDevitt, LaRosa, Cifter, and Van Der Meer render obvious claims 1-2, 4, 6-10, 13-14, 16, 19, and 32.
2. Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt et al. (US 2003/0050589, Mar. 13, 2003) (hereinafter McDevitt) in view of LaRosa et al. (US 2021/0015836, Jan. 21, 2021) (hereinafter LaRosa), Cifter et al. (EP 2514409, Oct. 24, 2012) (hereinafter Cifter), and Van Der Meer (Lotion Making 101, Jun. 16 , 2018) (hereinafter Van Der Meer) and further in view of Lukic et al. (Cosmetics, Aug. 4, 2021, 8, 69) (hereinafter Lukic).
The teachings of McDevitt, LaRosa, Cifter, and Van Der Meer are discussed above.
The combined teachings of McDevitt, LaRosa, Cifter, and Van Der Meer do not disclose wherein the composition has a pH of 5.0-7.0.
However, Lukic discloses that there is a high level of agreement that topical products should be acidified and possess pH in the range of 4 to 6 (Abstract).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the topical composition of McDevitt in view of LaRosa, Cifter, and Van Der Meer to have a pH of 5 to 6 since this is a known and effective pH for topical products as taught by Lukic.
Accordingly, the combined teachings of McDevitt, LaRosa, Cifter, Van Der Meer, and Lukic render obvious claim 17.
3. Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt et al. (US 2003/0050589, Mar. 13, 2003) (hereinafter McDevitt) in view of LaRosa et al. (US 2021/0015836, Jan. 21, 2021) (hereinafter LaRosa), Cifter et al. (EP 2514409, Oct. 24, 2012) (hereinafter Cifter), and Van Der Meer (Lotion Making 101, Jun. 16 , 2018) (hereinafter Van Der Meer) and further in view of Fransiska et al. (IOP Conf. Ser.: Earth Environ. Sci. 715 012050, Published Online Nov. 16, 2020) (hereinafter Fransiska).
The teachings of McDevitt, LaRosa, Cifter, and Van Der Meer are discussed above.
The combined teachings of McDevitt, LaRosa, Cifter, and Van Der Meer do not disclose the composition viscosity.
However, Fransiska discloses that the standard viscosity value for lotion is 2000-50000 cP (Pg. 6).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the topical lotion composition of McDevitt in view of LaRosa, Cifter, and Van Der Meer to have a viscosity of 2000-50,000 cP since this is the standard viscosity value for lotions as taught by Fransiska.
Accordingly, the combined teachings of McDevitt, LaRosa, Cifter, Van Der Meer, and Fransiska render obvious claim 18.
4. Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt et al. (US 2003/0050589, Mar. 13, 2003) (hereinafter McDevitt) in view of LaRosa et al. (US 2021/0015836, Jan. 21, 2021) (hereinafter LaRosa), Cifter et al. (EP 2514409, Oct. 24, 2012) (hereinafter Cifter), and Van Der Meer (Lotion Making 101, Jun. 16 , 2018) (hereinafter Van Der Meer) and further in view of Dutta et al. (US 5,529,830, Jun.25, 1996) (hereinafter Dutta) and Burkinshaw (Physico-chemical Aspects of Textile Coloration, SDC, 2016) (hereinafter Burkinshaw).
The teachings of McDevitt, LaRosa, Cifter, and Van Der Meer are discussed above.
The combined teachings of McDevitt, LaRosa, Cifter, and Van Der Meer do not disclose wherein the inner layer comprises a combination of nylon 66 and elastane (i.e., spandex and wherein said layer is formed form a knitted yarn.
However, Dutta discloses a stretchable layered fabric laminate has excellent stretch and recovery properties and is useful for the manufacture of form-fitting articles of protective clothing (Abstract). Suitable form fitting articles include a sleeve (col. 3, line 39-45). The stretchable fabric laminate is formed of a composite layer bonded to at least one layer of an elastic fabric (col 4, line 35-40). The elastic fabrics are typically composed of a hard or non-elastomeric fiber and an elastic fiber where suitable hard fibers include synthetic fibers such as nylon and suitable elastic fibers include polyurethane block copolymer-based fibers sold as Lycra™ or Spandex fibers (col 10, line 40-49). Knitted fabrics are preferred as the elastic fabrics used in the stretchable laminate. Such elastic knitted fabrics are typically composed of a hard fiber yarn that is non-elastomeric and an elastomeric Lycra™ or Spandex yarn. The knit has elastic characteristics by virtue of the structure of the knit and its elastomeric fiber content. More specifically, knitted fabrics having 5 to 20% elastomeric fiber content and from 95 to 80% hard fibers have been found to be very useful. A knitted fabric having 80% of nylon 6,6 fiber and 20% of Lycra™ fiber is a typical example of an elastic fabric suitable for use (col 10, line 50-62).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, McDevitt in view of LaRosa, Cifter, and Van Der Meer discloses wherein the sleeve may be formed from any material and may comprise an elastic fabric. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of McDevitt in view of LaRosa, Cifter, and Van Der Meer to comprise the elastic fabric of Dutta, since it is a known elastic fabric for use in formulating form-fitting sleeves as taught by Dutta.
The combined teachings of McDevitt in view of LaRosa, Cifter, Van Der Meer, and Dutta differ insofar as not disclosing wherein the knitted fabric is 2-ply and not disclosing its dtex or filament count.
However, Burkinshaw discloses that Fiber fineness is one of the most important fiber attributes not only because it is a commonly used indicator of fiber quality but also because it influences several other fiber characteristics, such as specific surface area, stiffness, handle, torsional rigidity, fiber cohesion, yarn uniformity, capillary wetting and wicking (Pg. 27). Yarns are often characterized in terms of their fineness, as exemplified by super fine 2–7.5 tex; fine 7.5–16 tex; medium/coarse 16–40 tex; coarse >45 tex, where 1 dtex = 0.1 tex (Pg. 28). The fineness of multifilament man-made fiber yarns is often denoted in terms of dtex per filament, dtexpf, which is the decitex of the yarn divided by the number of filaments within that yarn (Pg. 28). Coarse yarns often are produced by twisting together one or more yarns, the fineness of the ensuing plied or folded yarns being the sum of the component yarns (e.g. one 30 dtex and one 20 dtex yarn will produce a 50 dtex folded yarn) Pg. 28). The level of twist affects both the density and strength of a yarn (Pg. 33).
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). As discussed above, dtex, twist (i.e., plying), and number of filaments impact yarn fineness as well as density and strength. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed dtex, number of plies, and number of filaments to yield the desired yarn fineness, density, and strength.
Regarding the amount elastane (i.e., spandex) recited in instant claim 33, as discussed above, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). As discussed above, in a preferred embodiment, the knitted fabric used contains 80% nylon 66 and 20% spandex. As such, since the amounts disclosed by McDevitt in view of LaRosa, Cifter, Van Der Meer, and Dutta are close to the claimed amounts, the claimed amounts would have been obvious and the amounts disclosed by McDevitt in view of LaRosa, Cifter, Van Der Meer, and Dutta meet the instantly recited limitations.
Alternatively, 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). The ratio of hard fibers and elastomeric fibers determines elastic characteristics of the final garment. As discussed above, knitted fabrics having 5 to 20% elastomeric fiber content and from 95 to 80% hard fibers have been found to be very useful. Suitable elastomeric fibers include spandex and suitable hard fibers include nylon, preferably nylon 66. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have used nylon 66 as the hard fiber in an amount ranging from 80 to 95% to yield the desired elastic characteristics of the knitted fabric.
Accordingly, the combined teachings of McDevitt, LaRosa, Cifter, Van Der Meer, Dutta and Burkinshaw render obvious claim 33.
Conclusion
Claims 1-2, 4, 6-10, 13-14, 16-19, and 32-33 are rejected.
Claims 20-22, 25, 27, and 30 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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