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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on November 28, 2023. The priority date is June 3, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 28, 2023 is being considered by the examiner. The signed IDS form is attached with the instant office action.
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 13-15, 17-18, 20-21, 24-26, 28 are rejected under 35 U.S.C. 103 as being unpatentable over Michael Cushman and John Lyftogt (WO2013062424A1).
Regarding claim 13, 15, Cushman teaches a medicament for use in treatment of pain and/or inflammation comprising vitamin D and one or more saccharides and/or sugar alcohols, wherein the medicament is formulated for topical and/or transdermal application (see claim 1). Cushman also teaches wherein the medicament further comprises of one or more salts (see claim 2), and wherein the salt can be selected from a group which comprises of magnesium lactate (see claim 21). Cushman teaches the compositions are intended for topical application (see claim 1).
“An inverse relationship has also been observed between severity of pain and serum level of magnesium” (see page 4, para. 3).
Regarding claim 14, Cushman teaches the salts to be in a concentration of 0.1-6.5% (see claim 24).
Regarding claim 17, Cushman teaches “topical or transdermal applications may include, but are not limited to, the following: lotions, creams, emulsions, ointments, gels, foams, powders, pastes, oils, transdermal patches, microneedles, lipid delivery systems, impregnated sheet materials, drops and sprays” (see page 9, para. 5).
Regarding claim 18, Cushman teaches wherein excipients consisting of C8-C10 triglycerides are incorporated into the composition (see page 15, examples of compositions).
Regarding claim 20, Cushman teaches wherein the sugar alcohol comprises of glycerol (see claim 13).
Regarding claim 21, Cushman teaches wherein the alcohol can be cetyl alcohol (see page 16, formulation 1).
Regarding claims 24-25, Cushman teaches wherein the composition comprises polyethyleneglycol ethers (see page 15, examples of compositions).
Regarding claim 26, Cushman teaches the composition to comprise of one or more preservatives (see claim 31).
Regarding claim 28, Cushman teaches “Substitution of sodium chloride by sodium succinate in the combination cream formulation was observed to provide a cooling effect” (see example 9, page 14).
Cushman teaches magnesium lactate from a list of other preferable components; however it would have been obvious to persons having ordinary skill in the art before the effective filing date to select magnesium lactate and vitamin together in a composition for treating pain because Cushman teaches these two components are used for such a treatment. Selecting these from the list which are taught for the same purpose as the instant invention would have been prima facie obvious given the prior art and is well within the purview of any skilled artisan. Additionally, there would have been no undue experimentation needed in doing selecting the instant components as they are described as being useful for the same purpose which is treating pain.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Michael Cushman and John Lyftogt (WO2013062424A1) as applied to claims 13-15, 17-18, 20-21, 24-26, 28 above, and further in view of John Lyftogt (US20110274743A1).
Cushman teaches the method of treating pain as instantly disclosed however is silent on the composition comprising the specific amount of vitamin D.
Lyftogt’s general disclosure is to medicaments for treating pain and inflammation.
Regarding claim 16, Lyftogt teaches “A composition for the treatment of at least one selected from the group consisting of neurogenic inflammation, and neuropathic pain, and combinations thereof, wherein the composition comprises calciol (cholecalciferol) and wherein the composition is formulated for transdermal application” (see claim 1). Lyftogt teaches “the composition as claimed in claim 4, wherein the calciol (cholecalciferol) is present in a concentration of 40,000 IU/gram” (see claim 5).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use 40,000 IU/mL because Lyftogt teaches this is the effective amount in IU for treating pain.
Claims 22 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Michael Cushman and John Lyftogt (WO2013062424A1) as applied to claims 13-15, 17-18, 20-21, 24-26, 28 above, and further in view of Bob Fuladi (US20190380956A).
Cushman teaches the method of treating pain as instantly disclosed however is silent on the composition comprising black pepper, turmeric or one or both of mono- glycerides of long chain fatty acids and di-glycerides of long chain fatty acids.
Fuladi’s general disclosure is to topical compositions for pain relief.
Fuladi teaches topical pain relief formulations which comprise of Piper nigrum (black pepper) oil, Curcuma longa (tumeric) oil, and sorbitan monostearate (see 0016, table 2, 0026).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to look to Fuladi’s formulation to combine Piper nigrum (black pepper) oil, Curcuma longa (tumeric) oil, and sorbitan monostearate in creating a pain relief composition because these components are known to be combined together for pain relief and reducing inflammation.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Michael Cushman and John Lyftogt (WO2013062424A1), Bob Fuladi (US20190380956A) as applied to claims 13-15, 17-18, 20-22, 24-26, 28 above, and further in view of Sheah Yee Ghan et. al. (Influence of Soya Lecithin, Sorbitan and Glyceryl Monostearate on Physicochemical Properties of Organogels, Food Biophysics, 2020, 15:386-395).
Cushman teaches the method of treating pain as instantly disclosed however is silent on the composition comprising glyceryl monostearate.
Ghan’s general disclosure is to different properties of organogelators (see abstract).
Ghan teaches “Recently, structuring agents which are known as organogelators, have been used to structure edible oil to produce organogels, through organogelation process [3]. This method has been applied as an alternative route to replace PHO in food products. Briefly, an organogel is a semi-solid formulation prepared by solubilizing the solid components in the apolar phase. Aggregation of organogelator molecules in the solvent forms a 3-D architecture that helps to hold the solvent and turn it into gel [4]” (see Introduction, page 386). Among all the organogelators, considerable attention was given to food emulsifiers with good gelation capacities such as sorbitan monostearate (SMS), soya lecithin (SL) and glyceryl monostearate (GMS)” (see bottom of 386 and top of 387).
“The bulky sorbitan head group of SMS restricted the orderly arrangement of the molecules and reduced the intermolecular interaction in the organogel system, lead to weak gel formation. Nevertheless, the presence of hydrogen bond between the glycerol head group of GMS and the organization of the long alkyl chains of SL via van der Waals interactions support the formation of strong gel network by SL and GMS.” (see Conclusions, page 395).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use glyceryl monostearate in the formulation for creating pain relief compositions because this component is known to support the formation of strong gel networks for solubilizing solid components in apolar phases during emulsification processes. Fuladi already teaches using sorbitan monostearate in pain relief formulations and it is prima facie obvious to use an equivalent known for the same purpose and expect similar results.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Michael Cushman and John Lyftogt (WO2013062424A1) as applied to claims 13-15, 17-18, 20-21, 24-26, 28 above, and further in view of Heinz Eggensperger et. al. (US5670160).
Cushman teaches the method of treating pain as instantly disclosed however is silent on the composition comprising 3-(2-ethylhexyloxy)propane-1,2-diol or imidazolidinyl urea as a preservative.
Eggensperger’s general disclosure is to preservatives.
Eggensperger teaches “a preservative for compositions having an aqueous phase, said preservative consisting essentially of:
a) from 10 to 30% by weight of an organic acid selected from the group consisting of benzoic acid, dehydroacetic acid, undecylenic acid, esters of such acids, salts of such acids, and mixtures thereof;
b) from 40 to 80% by weight of an alcohol selected from the group consisting of benzyl alcohol, 2-phenoxyethanol, a phenoxybutanol and a phenoxypropanol;
c) from 0.5 to 10% by weight of a poly(hexamethylenebiguanide) salt in which the anion is selected from the group consisting of hydrochloride, acetate, lactate, benzoate, propionate, 4-hydroxybenzoate, sorbate and salicylate; and
d) from 0.1 to 20% by weight of a compound selected from the group consisting of 3-(2-ethylhexyloxy)-propane-1,2-diol, 3-heptyloxypropane-1,2-diol, 3-octyloxypropane-1,2-diol and 3-dodecyloxypropane-1,2-diol” (see claim 3).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to combine the preservative formulation taught by Eggensperger in the pain relief composition taught by Cushamn because Cushman composition comprises of aqueous phases and Eggensperger teaches preservatives that would be suitable in aqueous phases of the composition.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Michael Cushman and John Lyftogt (WO2013062424A1) as applied to claims 13-15, 17-18, 20-21, 24-26, 28 above, and further in view of Reza Ghorbani (US20120082739A1).
Cushman teaches the method of treating pain as instantly disclosed however is silent on the composition comprising Boswellia extract or eucalyptus essential oil.
Ghorbani’s general disclosure is to methods and compositions for treating pain.
Ghorbani teaches “Boswellia extract is best known among herbalists as a treatment for arthritis. One of its primary active ingredients, boswellic acid, is an anti-inflammatory that can be used in ointments to ease joint pain. Boswellia extract can also be taken internally as an anti-inflammatory agent, much like NSAIDs (non-steroidal anti-inflammatory agents), such as ibuprofen, which is commonly used to treat pain. However, unlike NSAIDs, Boswellia extract can be used for significant periods of time without causing stomach upset” (see 0035).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to combine Boswellia extract in the composition taught by Cushman because as Ghorbani teaches Boswellia extract can treat pain and unlike NSAIDS can be used for significant periods of time without causing stomach upset.
Given the prior art there would have been a reasonable expectation of creating the instant invention.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655