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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/29/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 04/29/2026 is acknowledged. Claim 1 is amended and claims 4-7 and 12-27 are canceled. Claims 28-29 are new. Claims 1-3, 8-11, and 28-29 are currently pending and are examined on the merits herein.
Priority
The instant application filed 08/23/2022, is a 371 filing of PCT/US2021/019354, filed 02/24/2021, which claims benefit to provisional 62/981273, filed 02/25/2020.
Withdrawn Rejections
Claims 1, 3, 5, 8-9 and 11 were rejected under 35 U.S.C. 103 as being unpatentable over Trimble and Okamoto. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 1-9, 11, 23-24, and 26-27 were rejected under 35 U.S.C. 103 as being unpatentable over Trimble, Okamoto, Ogata, and Jun. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 1-11 and 23-27 were rejected under 35 U.S.C. 103 as being unpatentable over Trimble, Okamoto, Ogata, Jun, and Sundberg. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claim Rejections - 35 USC § 112(b)
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 2 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 2 recites “wherein a ratio of lidocaine to benzocaine ranges from 1.5 to 3”. Such language is unclear since the amounts are reported as a quotient rather than an actual ratio. The recitation of “ratio” followed by “1.5 to 3” makes it unclear if the claim is drawn to a ratio of 1.5:3 or if this is a range being expressed by the quotients of lidocaine divided by benzocaine. For the sake of compact prosecution, the claim will be interpreted as the latter. Please either define the ratio as (lidocaine/benzocaine) or report the values in proper ratio format (i.e., 1.5:1 to 3:1).
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 1-3, 8-9, 11, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Trimble, J., O., (US 2017/0319534 A1, 11/09/2017, IDS dated 08/23/2022), hereinafter Trimble in view of Buyuktimkin, S., et al. (WO 2011014850 A2, 02/03/2011, PTO-892), hereinafter Buyuktimkin, and Ogata, N., et al. (WO 2014/123100 A1, IP.com translation, 08/14/2014, on record), hereinafter Ogata, and Kang, L., et al. (2000). Physicochemical studies of lidocaine–menthol binary systems for enhanced membrane transport, International Journal of Pharmaceutics, Volume 206, Issues 1–2, Pages 35-42 (PTO-892), hereinafter Kang, and Okamoto, K., et al. (US 2020/0030305 A1, 01/30/2020, IDS dated 08/23/2022), hereinafter Okamoto, as evidenced by SpecialChem. (n.d.). Sodium acrylate/sodium acryloyldimethyl taurate copolymer. Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer: Cosmetic Ingredient INCI, (on record), hereinafter SpecialChem.
Trimble discloses a eutectic anesthetic composition used to deliver pharmaceutical products topically (abstract).
Regarding claim 1: The topical composition comprises at least one discontinuous phase (i.e., dispersed phase) in a continuous phase, with each discontinuous phase including a eutectic mixture of first and second pharmaceutically acceptable components which are both pharmacologically active agents (¶ [0010]). The eutectic emulsion should preferably emulsify eutectic mixtures of anesthetics with lipophilic surfactants in water (¶ [0056]), which reads on the continuous phase being aqueous. Eutectic emulsion drug uptake capacity experiments were conducted by dissolving 20.0% Benzocaine, 10.0% Lidocaine and 4.0% Tetracaine into the eutectic emulsion of Example 1 (¶ [0092]; Fig. 1). The 10% of Lidocaine reads on its instantly claimed amount (i.e., 10-20%).
Regarding claim 3: Trimble discloses the inclusion of thermogelling agents (¶ [0053]; claim 1). Specifically, the thermogelling agent is a hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer (¶ [0079]; table 1). The thermogelling agent is added to the emulsion phase of the composition following the combination of the water and oil phase (¶ [0090]). Hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer is water soluble as evidenced by SpecialChem (p. 2, technical profile). Thus, it is inherent that the hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer, which is incorporated into the emulsion following the addition of both water and oil phases as taught by Trimble, would become incorporated within the aqueous phase of the emulsion since it is water soluble.
Trimble further discloses that to achieve a plastic property, thermogelling agents are added to the O/W emulsion resulting in significant control of the release and permeation rate of anesthetics (¶ [0057]). The thermogelling agent is present at a concentration range from about 0.1 to 4.0 weight percent (¶ [0079]; claim 12). Trimble also teaches that it is preferred that the eutectic emulsion compositions have high viscosity/no separation due to API as well as no shear stress from the ointment mill/EMP (abstract; ¶ [0066]; ¶ [0074]).
The teachings of Trimble differ from that of the instantly claimed invention in that Trimble does not explicitly teach an eutectic mixture with menthol nor an aqueous phase comprising bupivacaine as recited in claim 1. Trimble also fails to explicitly teach the amounts of every agent but lidocaine, as recited in claims 1, 8, and 11, and the specific properties of claims 9 and 28-29.
Buyuktimkin discloses topical compositions, methods of preparation, and methods of treatment involving the incorporation of a eutectic melt into a formulation. The improved formulation can enhance permeability and bioavailability (abstract). Buyuktimkin teaches compositions comprising an anti-fungal agent, a eutectic agent, and an optional low-boiling solvent ([0012]). The compositions may further comprise a second eutectic agent as well, wherein the eutectic agent and the second eutectic agent form a eutectic melt, which enhances the delivery of the anti-fungal agent or permits higher concentrations of the antifungal agent to be incorporated in the pharmaceutical composition ([0013]). "Eutectic agent" includes a compound that, in combination with at least a second eutectic agent, forms a eutectic melt. Representative eutectic agents include menthol and certain pharmaceutical agents (e.g., allylamine antifungal agents; local anesthetics such as lidocaine and prilocaine), and the like ([0047]). Exemplary eutectic agents include menthol (Table 1; claim 9) and pharmaceutically active agents such as benzocaine, tetracaine, lidocaine, and more ([0087]; claims 22 and 27-28). Lastly, it is taught if a mixture of compounds A and B or compounds B and C can form a eutectic melt, compounds A, B, and C can each be a eutectic agent even if compounds A and C cannot be combined with each other to form a eutectic melt ([0048])."Eutectic melt" includes a combination of two or more eutectic agents that form a substantially homogeneous mixture of liquids that is stable at one or more temperatures between about 10 °C and about 50 °C. The eutectic melt is further characterized in that the melting point of the eutectic melt is lower than the melting point of at least one of the two or more eutectic agents that comprise the mixture ([0048]).
Ogata teaches a patch-type topical anesthetic comprising a component (A) which includes lidocaine and a component (B) which includes benzocaine (abstract). Specifically, the anesthetic comprises a eutectic mixture of lidocaine and benzocaine capable of obtaining excellent sustainability while enhancing the expression of the effect of the anesthetic component (p. 3, para. 2). The mass ratio of component (A) (i.e., lidocaine) to component (B) (i.e., benzocaine) is most preferably 60:40 to 72:28. When the mass ratio of component (A) to component (B) is within the above range, the immediate effect and sustainability of the anesthetic effect can be made particularly excellent (p. 3, para. 7).
Kang discloses the melting properties of lidocaine and l-menthol binary systems (abstract). Terpenes such as menthol, thymol and cineole, depress the melting points of other compounds such as local anesthetics. In this study, menthol was selected as the melting point depressing agent for lidocaine due to its safety and availability (Intro, para. 2). A eutectic mixture of lidocaine and menthol was formed at a ratio of 30:70 (w/w) (abstract; Fig. 1) and other binary ratios were studied (Fig. 1; Table 1). Melt systems containing lidocaine and l-menthol at the ratios of 30:70, 40:60 and 50:50 (w:w), clearly showed a concentration dependency regarding permeation rates. It is known that the higher the drug concentration in the melt systems used, the higher the thermodynamic activity, and therefore, the higher the driving force for drug penetration. Assuming the same vehicle effects on the skin, the saturated melt systems of lidocaine which possess the maximum thermodynamic activity are expected to produce the highest permeation rate; however, crystallization of lidocaine from the saturated systems during storage may occur (Section 3.5, para. 3).
Okamoto discloses a local anesthetic-containing acidic emulsion composition (Title; abstract). The local anesthetic is one or more selected from the group consisting of levobupivacaine, bupivacaine, ropivacaine and salts thereof (¶ [0011]; claim 19). The local anesthetic is preferably a water-soluble salt such as a hydrochloride (¶ [0028]-[0029]; Examples). The emulsion is specifically a O/W type emulsion (¶ [0011]; claim 1), wherein the proportion of the local anesthetic in an aqueous phase is 15% or more of the total amount of the local anesthetic in the composition (¶ [0011]; claim 26). The amount of the local anesthetic is 0.01 to 5% by mass, relative to the whole composition (¶ [0031]). The composition is used for pain control which is achieved via topical application (¶ [0011]; claim 30).
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate menthol into the eutectic mixture of Trimble since menthol is a known and routine eutectic agent in the art, as taught by Buyuktimkin and Kang. Specifically, Buyuktimkin teaches that menthol and local anesthetics such as lidocaine, benzocaine, and tetracaine are all known eutectic agents. Thus, one of ordinary skill in the art could have substituted the tetracaine of Trimble with the menthol of Buyuktimkin, both of which are known eutectic agents in the art, to predictably yield the instant eutectic mixture. One of ordinary skill in the art would have been motivated to use menthol due to its safety and availability as taught by Kang. Furthermore, Buyukitimkin teaches that when A + B and B + C form eutectic melts, then A + B + C can be used as eutectic agents together. Ogata further teaches that lidocaine and benzocaine are known to form a binary eutectic melt (i.e., A + B) while Kang teaches that lidocaine and menthol are known to form a binary eutectic melt (i.e., B + C). These references together provide one of ordinary skill in the art with a reasonable expectation of success in forming a eutectic melt of lidocaine, benzocaine, and menthol (i.e., A + B + C).
Upon the substitution of tetracaine for menthol, as discussed above, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of menthol in order to form a eutectic melt with the desired melting point and permeability. As such, one of ordinary skill in the art would have arrived at the instantly claimed amount of menthol through no more than routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such a 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). Furthermore, the optimization of a result effective parameter like melting point or permeability, which is a function of the menthol concentration, is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
Regarding the amount of benzocaine, it would have been prima facie obvious to one of ordinary skill in the art to implement the mass ratio taught by Ogata since such a mass ratio is known and routine in the art of lidocaine/benzocaine eutectics. Based on 10% lidocaine, the 60:40 to 72:28 (L:B) ratio of Ogata would have resulted in benzocaine at an amount of 6.7% to 3.8%. One of ordinary skill in the art would have been motivated to provide the eutectic with such a ratio and amount, since it provides excellent immediate effect and sustainability of the anesthetic. The 6.7% to 3.8% of benzocaine falls within the instantly claimed range of claim 1 (i.e., 3-8%) while the ratio of 60:40 to 72:28 (L:B) (i.e., 1.5 to 2.57), further reads on that of instant claim 2.
Lastly, in regards to claim 1, it would have been prima facie obvious to one of ordinary skill in the art to incorporate bupivacaine into the aqueous phase of the combined anesthetic emulsion above since it is known and routine to incorporate bupivacaine into the aqueous phase of anesthetic emulsions as taught by Okamoto. One of ordinary skill in the art could have combined a water soluble salt of bupivacaine as taught by Okamoto with the anesthetic emulsion of Trimble via known techniques to predictably yield the instant invention. One of ordinary skill in the art would have been motivated to do so to increase the anesthetic effect of the total composition and to provide two modes of anesthetic action, one from the oil phase and one from the aqueous phase. One of ordinary skill in the art would have had a reasonable expectation of success in adding bupivacaine to the aqueous phase of Trimble since Okamoto teaches methods of adding water-soluble salts of local anesthetics to emulsions in order to incorporate them into the aqueous phase.
Regarding claim 8, Trimble discloses about 0.1 to 4.0 weight percent of the thermogelling agent, as discussed above. Trimble also teaches that efficacy improvements of the eutectic anesthetic, such as active penetration, skin adhesion, and storage stability, are dependent on increased thermogelling agents (¶ [0068]). While the weight percent taught by Trimble is not within the instantly claimed range, it would have taken no more than routine experimentation by one of ordinary skill in the art to reach the claimed weight percent of a thermogelling agent in the combined composition of Trimble and Okamoto depending on the properties desired in the final composition. Generally, differences in concentration 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 9, Trimble teaches it is preferred that the eutectic emulsion compositions have high viscosity and no shear stress from the ointment mill/EMP (abstract; ¶ [0066]; ¶ [0074]). Accordingly, viscosity and shear rate, which are directly related to shear stress, are result effective parameters. One of ordinary skill in the art would have arrived at the claimed viscosity and shear rate in the combined composition of Trimble and Okamoto through no more than the optimization of a result effective parameter, as motivated by the desire to optimize the performance of the final composition. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). Furthermore, since the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 11, it would have been prima facie obvious to incorporate bupivacaine at an amount of 0.01 to 5% by mass in the combined composition since this is a known and routine amount of bupivacaine to incorporate in the aqueous phase of an anesthetic emulsion as taught by Okamoto. One of ordinary skill in the art could have incorporated 0.01 to 5% bupivacaine in the aqueous phase of the emulsion above via known techniques to predictably yield the instant invention.
Regarding claims 28 and 29, since the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Claims 1-3, 8-11, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Trimble, Buyukitimkin, Ogata, Kang, and Okamoto as applied to claims 1-3, 8-9, 11, and 28-29 above, and further in view of Sundberg, M. et al. (US 20130116328 A1, 05/09/2013, IDS filed 11/07/2025), hereinafter Sundberg, as evidenced by Bodratti AM, et al. (2018). Formulation of Poloxamers for Drug Delivery. J Funct Biomater. 9(1):11 (on record), hereinafter Bodratti.
The combined teachings of Trimble, Buyukitimkin, Ogata, Kang, and Okamoto are discussed above.
The combined teachings of Trimble, Buyukitimkin, Ogata, Kang, and Okamoto differ from that of the instant invention in that none explicitly teach wherein the gelling agent comprises a block copolymer comprising hydrophobic and hydrophilic blocks as defined in claim 10.
Sundberg teaches a thermogelling pharmaceutical composition comprising local anesthetics in base form and which is suitable for topical administration. The stabilized thermogelling pharmaceutical composition comprises an anesthetically effective amount of one or more local anesthetics and one or more surfactants in an amount of at least 15% by weight to provide the composition with thermogelling properties (¶ [0008]). Surfactants used in the composition possess thermoreversible gelling properties and are non-ionic block copolymers of polyoxy(ethylene) and poly(oxypropylene), generally referred to as poloxamers (¶ [0026]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art to use a poloxamer as the thermogelling agent in the combined composition of Trimble, Buyukitimkin, Ogata, Kang, and Okamoto since poloxamers are known and routine thermogelling agents in the art of topical anesthetic compositions a taught by Sundberg. One of ordinary skill in the art could have substituted the thermogelling copolymer taught by Trimble above with a poloxamer of Sundberg to predictably generate the instantly claimed emulsion. Furthermore, poloxamers are water-soluble, amphiphilic block copolymers with hydrophilic PEO blocks and hydrophobic PPO blocks as evidenced by Bodratti. Thus, poloxamers read on the gelling agent of claim 10, and will be present in the aqueous phase as evidenced by their water solubility.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modification since Trimble and Sundberg teach the incorporation of thermogelling agents into topical anesthetic emulsions. Trimble further teaches that acceptable thermogelling agents include long-chain straight polymers (¶ [0079]; claim 1), which encompasses poloxamers.
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that the ternary eutectic of Trimble has no technical relevance to the claimed binary anesthetic of lidocaine and benzocaine. Okamoto fails to address eutectic mixtures and Ogata is limited to solid patches and cannot contemplate the present emulsion (p. 4 of Remarks).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The ternary eutectic of Trimble contains both benzocaine and lidocaine and is therefore very relevant to the eutectic of claim 1, which appears to be a ternary eutectic as well, only it comprises menthol in place of the tetracaine of Trimble. Okamoto’s lack of a eutectic teaching does not prevent its combination with Trimble, especially given that bupivacaine is not part of the eutectic mixture in the claims but is a separate anesthetic included in the aqueous phase. Ogata’s teaching of solid patches does not prevent its teaching from being relevant to emulsions, especially since a eutectic solution must be formed prior to its application on or in a solid patch.
(2) Applicant argues that Okamoto is specifically designed for rapid release of anesthetic, citing paragraphs 1 and 43 of Okamoto. Applicant asserts that the explicit rejection of sustained release is in direct opposition to the presently claimed compositions that exhibit sustained release, citing the abstract of the present application (p. 5 of Remarks).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sustained release) are not recited in claim 1. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, claims 28 and 29 simply define the release profile of lidocaine, benzocaine, and bupivacaine to occur over a period of days and to be different from one another. These claims do not provide a specific definition of the bupivacaine release profile, which under the broadest reasonable interpretation of these claims could be immediate while the lidocaine and benzocaine are more sustained. Additionally, since there is no specific structural difference between the composition made obvious by the prior art and the claimed composition, the recited properties must be treated as inherent to the composition until proven otherwise.
(3) Applicant argues that the local anesthetic of Okamoto originates in the dispersed oil phase and is subsequently driven to the continuous aqueous phase by acidifying the pH of the emulsion, citing paragraphs 42-43 of Okamoto. Thus, Okamoto cannot contemplate local anesthetics differing between the dispersed phase and the aqueous phase as claimed (p. 6 of Remarks).
Okamoto is relied on above for teaching the incorporation of a water soluble salt such as bupivacaine in an anesthetic emulsion. One of ordinary skill in the art would recognize that upon the addition of a water soluble salt of bupivacaine into the overall emulsion of Trimble, the preformed eutectic mixture of Trimble would remain in the dispersed phase of the emulsion, as taught by Trimble, while a water-soluble salt such as benzocaine HCl, which is not part of any eutectic mixture would incorporate into the aqueous phase. It is not required that Okamoto explicitly teach an emulsion with differing anesthetics in the oil and water phase, since anesthetics in the oil phase are already taught by Trimble.
(4) Applicants arguments with respect to Jun have been considered but are moot because the new ground of rejection does not rely on Jun.
Conclusion
No claims allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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