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 1-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/2023 is being considered by the examiner.
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 11 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.
Claim 11 recites a tea tree in transdermal patch, and it is unclear how a tree is included in a transdermal patch. Thus, the scope and boundary of claim is unclear, this is unclear. For compact prosecution purpose, tea tree is examined as tea tree oil.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 5-6, 9-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wilcox et al. (WO03077885) in view of Ramjit et al. (US20190350873) and Fang et al. (CN101518599. Machine translation).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Wilcox et al. teaches An anesthetic formulation and methods of use are disclosed. The formulation includes an oleaginous base vehicle, a free base anesthetic and a solubility enhancer. Further, the formulation may additionally include penetration enhancers, antioxidants, solubility enhancers, gelling agents, and antimicrobial agents. The inventive formulation may be incorporated into a drug delivery patch or a drug delivery gel (abstract). In one embodiment, the formulation includes an oleaginous base vehicle and a free-base anesthetic compound. In another embodiment, the free-base anesthetic may be lidocaine, prilocaine, bupivacaine, mepivocaine, etidocaine, butanilcaine, or trimecaine, or, alternatively, tetracaine, benzocaine, procaine, chlorprocaine, butamben, picrate, or dibucaine. In one version of this embodiment, the free-base anesthetic may be present in an amount between about 0.5% and about 20% by weight. In one version of this embodiment, more than one anesthetic may be used. In one version of this embodiment, the free-base anesthetic is tetracaine. In one version of this embodiment, the oleaginous base vehicle may be mineral oil, petrolatum, a natural oil, a fatty ester, or a fatty alcohol. In a further version of this embodiment, the natural oils may be cottonseed oil, sesame oil, peanut oil, mink oil or jojoba oil. In a further version of this embodiment, the fatty ester may be propylene glycol dicaprylate caprate, cetearyl octanoate, isopropyl myristate, isopropyl palmitate, isopropyl lanolate, acetylated lanolin, decyl oleate or hexyl laurate. In a further version of this embodiment, the fatty alcohol may be isohexadecyl, stearyl, lauryl, cetyl or oleyl alcohol. The oleaginous base may contain one or more humectants. In one version of this embodiment, the humectants may be glycerin, lanolin, or propylene glycol ([0012]). n a further embodiment, the formulations described in the previous embodiments may contain one or more of a penetration enhancer, an antioxidant, a gelling agent, and an antimicrobial agent in addition to the oleaginous base vehicle and free-base anesthetic or the oleaginous base vehicle, free-base anesthetic, and solubility enhancer. In one version of this embodiment, the penetration enhancer may be saturated or unsaturated fatty acids and esters, oxazolidinones, hydrophobic lactams, menthol, eugenol, and capsaicin. In another embodiment, the penetration enhancer may be ethyl oleate. In another version of this embodiment, the penetration enhancer may be present in an amount between about 1 percent and about 20 percent by weight. In one version of this embodiment, the antioxidant has a Log octanol/water partition coefficient about or greater than one. In one version of this embodiment, the antioxidant may be octyl gallate, tocopherols, ascorbyl palmitate, butylated hydroxyanisole, ascorbyl palmitate, butylated hydroxyl anisole, tocopherols excipient, tocopherol acetate or butylated hydroxytoluene. In one version of this embodiment, the antioxidant is present in an amount between about 0.001% and about 5% by weight ([0014]). The drug delivery patch may be a reservoir based patch, a matrix patch, a multi-laminate drug in adhesive patch, or a monolithic drug in adhesive patch ([0015]). In one embodiment of the invention, the solubility enhancer is selected from one or more of the following: alcohols such as benzyl alcohol, esters of hydrocarbons such as cetearyl ethyl hexanoate, cyclopentadecalactone (omega- pentadecalactone), isopropyl myristate, sorbitan monolaurate (Arlacel-20), and diverse excipients such as dimethylsiloxane, and essential terpenes from flowers and plants including peanut oil, lanolin, Eucalyptus oil and Tea tree oil and various terpenols ([0033]). In one embodiment of the invention, the solubility enhancer is present in an amount of between about 1 percent and about 20 percent by weight ([0036]). Generally, the antioxidant may be present in any amount allowing enhanced stabilization of the formulation. In one embodiment, the antioxidant is present in an amount between about 0.001% and about 5% by weight ([0043]). In one embodiment of the invention, the formulations described above are used for the treatment or prevention of pain. The formulations may be used for the treatment of various types of pain ([0052]).
Ramjit et al. teaches an adhesive patch comprises a release liner for the treatment of skin condition (abstract; [0001]). In an exemplary embodiment, the backing and the therapeutic adhesive composition have a circular or triangular or rectangular or square or oval shape or the like ([0029]). The backing layer comprises may comprise any suitable material known for use in the preparation of wound dressings and includes, but is not limited to, a foam, a polyurethane, a polyethylene, a polyester, a polyamide, polycellulose, cotton, or any mixture thereof ([0052]).
Fang et al. teaches giraldii nitsche extract slow-release patch and preparation method thereof (abstract). The composition for patch comprises one or more percutaneous enhancer selected from the group consisting of propylene glycol, glycerol, PEG300, PEG400, dimethyl acetamide, diethyl ethylene diamine, diethylamine, triethylamine, N-methyl morpholine, phenmethyl ammonium chloride, azone, urea, glyceryl monooleate, glyceryl monolaurate, olein, isopropyl myristate, dibutyl sebacate, dibutyl phthalate, geraniol, nerolidol, menthol, menthol acetate, menthol propyl ester, menthol butyl ester, menthol pentyl ester, menthol hexyl ester, menthol heptyl ester, menthol monooctyl ester, menthol pelargonic ester, menthol decatyl ester, menthol dodecyl ester, menthol tetradecyl ester, menthol hexadecyl ester, menthol octadecyl ester, menthol oleate, menthol lactate, menthol salicylate, menthol ester, camphor, eucalyptus oil, borneol, N-methyl-2-pyrrolidone, tween-20, tween-40, tween-60, tween-80, span-20, span-40, span-60, span-80, lactic acid, maleic acid, trans-butene diacid and oxalic acid; the amount of percutaneous enhancer is 0-20% (claims 1-4).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Wilcox et al. is that Wilcox et al. do not expressly teach backing layer, release liner and menthol salicylate. This deficiency in Wilcox et al. is cured by the teachings of Ramjit et al. and Fang et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wilcox et al., as suggested by Ramjit et al. and Fang et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to include backing layer and release liner in the transdermal patch system because backing layer and release liner are known and common component in the transdermal patch system as suggested by Ramjit et al. Therefore, it is obvious to include backing layer and release liner in the transdermal patch system and produce instant claimed invention with reasonable expectation of success. One of ordinary skill in the art would have been motivated to include about 0.5% of menthol salicylate as additional penetration enhancer in drug-in-adhesive layer because menthol salicylate is suitable penetration enhancer in transdermal patch. MPEP 2144.07. Under guidance from Ramjit et al. teaching one or more of a penetration enhancer; Fang et al. teaching 0-20% of percutaneous enhancer menthol salicylate, it is obvious for one of ordinary skill in the art to include about 0.5% of menthol salicylate as additional penetration enhancer in drug-in-adhesive layer and produce instant claimed invention with reasonable expectation of success.
Since Wilcox et al. teaches more than one anesthetic such as lidocaine and benzocaine, present in an amount between about 0.5% and about 20%, it is obvious to have 4.0% of lidocaine and 10% of benzocaine because each of lidocaine and benzocaine is in the range of 0.5% to about 20% and their total amount is also in the range of 0.5% to 20%.
Regarding claims 1, 3, 16-17, prior art teaches an anesthetic transdermal patch comprising a backing layer, drug-in-adhesive layer and release liner; the drug-in-adhesive layer comprises 1% of menthol (penetration enhancer), 0.5% of menthol salicylate (penetration enhancer), 4% of lidocaine and 10% of benzocaine.
Regarding claim 2, Ramjit et al. teaches polyester backing layer, reads on polyester skin fabric.
Regarding claims 5-6, 9-12 and 19, Wilcox et al. teaches tee tree oil (which is also known as Melaleuca oil) and tocopherols (reads on Vitamin E).
Regarding claims 13-15 and 20, to choose the shape of patch is within skill of one artisan in the art, as guidance from Ramjit et al. teaching a circular or triangular shape of patch, it is obvious to have a circular or triangular patch.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 4,7-8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wilcox et al. (WO03077885) in view of Ramjit et al. (US20190350873) and Fang et al. (CN101518599, Machine translation), as applied for the above 103 rejection for claims 1-3, 5-6, 9-17 and 19-20, further in view of Moyer et al. (US20210393639) and Kritikou (US20160184340).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Wilcox et al., Ramjit et al. and Fang et al. teaching have already been discussed in the above 103 rejection and are incorporated herein by reference.
Moyer et al. teaches composition in the form of patch ([0100, claims 1 and 17). The composition may comprise antimicrobial agents such as cationic surfactants (especially quaternary ammonium compounds), aloe vera, ashitaba, chlorhexidine, copper, dispersin B, cinnamon oil, clove oil, eucalyptus oil, tea tree oil, gentamicin, lactoferrin, lysostaphin N-halamines, nitric oxide, oleic acid, PLUNC protein, polyhexanide biguanide (PHMB), bacteriocin, selenium, silver compound, triclosan, zinc, and combinations thereof ([0095]).
Kritikou teaches pinosyns and spinosyn compositions as local anesthetics and antiarrhythmic agents (abstract). In one embodiment, the composition is in the form of patch (claims 1 and 15). Additional miscellaneous excipients may include bulking agents or fillers (e.g., starch), chelating agents (e.g., EDTA), antioxidants (e.g., ascorbic acid, methionine, vitamin E) and cosolvents, formulation detectable markers, aerosol propellants, sunscreen agents, perfumes or essential oils, powder base such as for example kaolin and a skin conditioning agent ([0077]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Wilcox et al. is that Wilcox et al. do not expressly teach aloe vera. This deficiency in Wilcox et al. is cured by the teachings of Moyer et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wilcox et al., as suggested by Moyer et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to include aloe vera because aloe vera is a suitable ingredient in transdermal patch. MPEP 2144.07, Under guidance from Wilcox et al. teaching antimicrobial agent; Moyer et al. teaching aloe vera as antimicrobial agent for patch, it is obvious for one of ordinary skill in the art to include aloe vera and produce instant claimed invention with reasonable expectation of success.
In arguendo that Wilcox et al. does not teach tea tree oil and vitamin E, one of ordinary skill in the art would still have been motivated to include tea tree oil and vitamin E in the patch because they are suitable ingredients in the patch. MPEP 2144.07. Under guidance from Wilcox et al. teaching antimicrobial agent and antioxidant; Moyer et al. teaching tea tree oil as antimicrobial agent for patch; Kritikou teaching Vitamin E as antioxidant for patch; it is obvious for one for ordinary skill in the art to include tea tree oil and vitamin E in the patch and produce instant claimed invention with reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613