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 .
Status of Claims
Receipt of Remarks/Amendments filed on 11/05/2025 is acknowledged. Claim 1 is amended and claims 12-22 are canceled. Claims 23-27 are new. Claims 1-11 and 23-27 are currently pending and 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.
Information Disclosure Statement
The information disclosure statement filed 11/05/2025 fails to comply with 37 CFR 1.97(c) because it lacks a timing statement as specified in 37 CFR 1.97(e) and a timing fee set forth in 37 CFR 1.17(p). It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement (IDS) submitted on 11/07/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The following rejections are necessitated by amendment:
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, 5, 8-9 and 11 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 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, (PTO-892), hereinafter SpecialChem.
Trimble discloses a eutectic anesthetic composition used to deliver pharmaceutical products topically (abstract). The topical composition comprises at least one discontinuous 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 and the continuous phase being provided by a pharmaceutically acceptable carrier (¶ [0010]). The eutectic emulsion should preferably emulsify eutectic mixtures of anesthetics with lipophilic surfactants in water (i.e., an O/W emulsion) (¶ [0056]). Examples of the adjuvant anesthetics include benzocaine, bupivacaine, and lidocaine among others (¶ [0075]). 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).
Thus, Trimble discloses an anesthetic emulsion comprising: a dispersed phase (i.e., a discontinuous phase) comprising a eutectic mixture as recited in claim 1. The eutectic mixture comprises an anesthetic component that consists of lidocaine and benzocaine. While the eutectic mixture further comprises tetracaine, the instant claim language does not preclude additional agents or anesthetics from being included in the eutectic mixture. As such, the composition of Trimble can be considered as an eutectic mixture comprising one anesthetic component consisting of benzocaine and lidocaine as well as an additional anesthetic component consisting of tetracaine, which falls within the instant claim scope. The emulsion of Trimble further comprises an aqueous continuous phase as recited in claim 1.
Trimble further discloses the inclusion of thermogelling agents (¶ [0053]; claim 1). 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]). 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]). 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 teach wherein the aqueous continuous phase comprises bupivacaine as recited in claim 1 nor its amount as recited in claim 11. Trimble also fails to explicitly teach wherein the gelling agent is comprised in the aqueous phase as defined by claim 3 and the gelling agent amount as recited in claim 8. Lastly, Trimble does not teach the specific viscosity and shear rate of claim 9.
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 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). The emulsion composition may comprise an additional active ingredient unless this compromises the effects of the present invention. The additional active ingredient may be any appropriate substance that is not contraindicated for use with the local anesthetic (¶ [0032]).
It would have been obvious to combine the compositions of Trimble and Okamoto before the effective filing date of the claimed invention by incorporating bupivacaine into the aqueous phase, as taught by Okamoto, of the anesthetic emulsion of Trimble to yield the instantly claimed invention. It would have been prima facie obvious to incorporate bupivacaine into the aqueous phase of the O/W anesthetic emulsion of Trimble since Okamoto teaches a O/W anesthetic emulsion which incorporates bupivacaine in the aqueous phase. The combination of prior art elements according to known methods to yield predictable results constitutes a prima facie case of obvious. See MPEP 2143. Additionally, the anesthetic emulsions of Trimble and Okamoto are both used for topical pain relief. “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). One of ordinary skill in the art would have had a reasonable expectation of success in combining the compositions of Trimble and Okamoto since Trimble teaches bupivacaine as an acceptable anesthetic in a topical anesthetic emulsion while Okamoto welcomes any additional active ingredient that is not contraindicated for use with the local anesthetic (i.e., bupivacaine). Thus, the entirety of instant claim 1 is obvious in view of Trimble and Okamoto.
Regarding the amount of bupivacaine as recited in claim 11, it would have been further obvious to incorporate bupivacaine into the aqueous phase of the combined composition of Trimble and Okamoto at an amount of 0.01 to 5% by mass, relative to the whole composition as taught by Okamoto above. It would have been prima facie obvious to incorporate bupivacaine at this amount since this is a known and effective amount of bupivacaine to incorporate into the aqueous phase of an anesthetic emulsion as taught by Okamoto.
Regarding claims 3, Trimble discloses a thermogelling agent as discussed above. The thermogelling agent is hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer. Hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer is water soluble as evidenced by SpecialChem (p. 2, technical profile). Thus, it would have been obvious to one of ordinary skill in the art 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.
Regarding claim 5, the combined composition of Trimble and Okamoto comprises 10.0% Lidocaine as taught by Trimble above.
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 or temperature 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).
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, as discussed above. 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).
Claims 1-9, 11, 23-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Trimble and Okamoto as applied to claims 1, 3, 5, 8-9, and 11 above, and further in view of Ogata, N., et al. (WO 2014/123100 A1, IP.com translation, 08/14/2014, PTO-892), hereinafter Ogata, and Jun, H., W., et al., (US 6299902 B1, 10/09/2001, IDS dated 08/23/2022), hereinafter Jun.
The combined teachings of Trimble and Okamoto are discussed above.
The combined teachings of Trimble and Okamoto differ from that of the instant invention in that neither Trimble nor Okamoto teach wherein the ratio of lidocaine to benzocaine ranges from 1.5 to 3 as recited in claims 2 and 23, nor wherein the benzocaine is present in an amount of 3-8 weight percent as recited in claim 6. Trimble and Okamoto also fail to teach wherein the eutectic mixture further comprises menthol as recited in claims 4 and 23, and the amount of menthol as recited in claims 7 and 24.
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 anesthetic may further comprise bupivacaine (p. 3, para. 5). 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).
Jun teaches a topical anesthetic preparation containing at least one local anesthetic agent and at least two melting point depressing agents. The preparation is a two-phase liquid composition that contains aqueous and oil phases, the oil phase having a relatively high concentration of a local anesthetic agent (abstract). Inclusion of the first and second melting point depressing agents yields an oil phase having a higher concentration of the local anesthetic agent, such as lidocaine, than has previously been achieved. Increasing the concentration of the local anesthetic agent in the oil phase at ambient temperature is desirable because it enhances transdermal absorption and efficacy (col. 3, lines 53-62). The local anesthetic in the two-phase composition may be lidocaine (col. 6, lines 32-35; claim 7) and the first melting point depressant (MP-A) may be menthol (col. 6, lines 40-41; claim 11). When menthol was used as the MP-A and mixed with lidocaine, ethyl alcohol and water at the ratios of Table 8, two phase melt systems were spontaneously formed at 20-25oC (Ex. 3; col. 11, lines 39-47). Such a composition comprises 0.88% MP-A (i.e., menthol) (table 8).
First, it would have been obvious to modify the combined composition of Trimble and Okamoto with the teachings of Ogata before the effective filing date of the claimed invention by using the lidocaine:benzocaine mass ratio of Ogata in the combined composition of Trimble and Okamoto. Ogata teaches a lidocaine:benzocaine mass ratio of 60:40 to 72:28 (i.e., 1.5 to 2.57), which falls within the range of claims 2 and 23. Additionally, the combined composition of Trimble and Okamoto comprises 10.0% Lidocaine as discussed above. Based on these teaching, the examiner calculates that the weight percent of benzocaine would be between 3.88 and 6.66%, which falls within the weight percent of claim 6. One of ordinary skill in the art would have been motivated to incorporate benzocaine at the mass ratio/weight percent taught by Ogata in order to provide a topical anesthetic composition having excellent immediate effect and sustainability as taught by Ogata. Additionally, such a ratio is known and effective for providing a eutectic mixture. One of ordinary skill in the art would have had a reasonable expectation of success since Ogata teaches a eutectic mixture of lidocaine and benzocaine for a topical anesthetic composition alike the topical anesthetic composition of Trimble and Okamoto which also comprises a eutectic mixture that includes both lidocaine and benzocaine.
Second, it would have been obvious to one of ordinary skill in the art to further modify the above composition with the teachings of Jun before the effective filing date of the claimed invention by incorporating menthol into the eutectic mixture of the combined composition as reasonably suggested by Jun to yield the instant invention of claims 4 and 23. One of ordinary skill in the art would have been motivated to incorporate menthol into the eutectic mixture, which comprises lidocaine, in order to depress the melting point of the lidocaine, thereby increasing its concentration in the oil phase which leads to improve transdermal absorption and efficacy as taught by Jun. One of ordinary skill in the art would have had a reasonable expectation of success in incorporating menthol into the eutectic mixture of the combined composition of Trimble, Okamoto, and Ogata since Jun teaches that menthol is compatible in topical anesthetic emulsions and the combined composition is a in topical anesthetic emulsion. Furthermore, the menthol of Jun depresses the melting point of lidocaine which is the desired technical effect of an eutectic mixture.
Regarding claims 7 and 24, it would have been further obvious to incorporate menthol at an amount of 0.88%, as taught by Jun, into the eutectic mixture of the combined composition. It would have been prima facie obvious since 0.88% is a known and effective amount of a melting point depressing agent/menthol to use in a topical anesthetic emulsion comprising lidocaine as taught by Jun and the combined composition comprises lidocaine.
Regarding claim 26, Trimble teaches it is preferred that the eutectic emulsion compositions have high viscosity and no shear stress from the ointment mill/EMP, as discussed above. 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, Okamoto, Ogata, and Jun 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).
Regarding claim 27, as discussed above, the combination of Trimble and Okamoto makes obvious the incorporation of 0.01 to 5% by mass of bupivacaine. It would have been prima facie obvious to also incorporate bupivacaine at this amount in the combined composition of Trimble, Okamoto, Ogata, and Jun since this is a known and effective amount of bupivacaine to incorporate into the aqueous phase of an topical anesthetic emulsion as taught by Okamoto.
Claims 1-11 and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Trimble, Okamoto, Ogata, and Jun as applied to claims 1-9, 11, 23-24, and 26-27 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 (PTO-892), hereinafter Bodratti.
The combined teachings of Trimble, Okamoto, Ogata, and Jun are discussed above.
The combined teachings of Trimble, Okamoto, Ogata, and Jun 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 claims 10 and 25.
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, Okamoto, Ogata, and Jun since poloxamers are known and routine thermogelling agents in the art of topical anesthetic compositions. 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 agents of claims 10 and 25, 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, which encompasses poloxamers.
Response to Arguments
Applicant's arguments filed 11/05/2025 have been fully considered but they are not persuasive:
Applicant argues that the ternary eutectic mixture of Trimble which comprises benzocaine, lidocaine, and tetracaine, has no technical relevance to the claimed binary anesthetic eutectic of lidocaine and benzocaine (p. 4 of Remarks).
As discussed in the above rejections, the instant claims define the eutectic mixture as comprising an anesthetic component (claim 1) or menthol and an anesthetic component (claim 23). Such language defines the eutectic mixture as inclusive of additional components other than the defined anesthetic component and menthol. While the claimed anesthetic component is defined as consisting of only lidocaine and benzocaine, the claims still encompass a eutectic mixture comprising additional agents other than menthol and the “anesthetic component consisting of lidocaine and benzocaine”.
Applicant argues that there is no motivation to combine Trimble and Okamoto to separately place bupivacaine in the aqueous phase since Trimble requires all anesthetics to be in the dispersed eutectic phase (p. 4 of Remarks). Additionally, Applicant argues that removing bupivacaine from the eutectic phase of Trimble and placing it in the aqueous phase would change the principle operation of the prior art invention being modified (p. 5 of Remarks).
The citation provided by the Applicant of paragraph [0012] in Trimble only suggests that additional components may be included in the eutectic mixture. This cannot be considered an explicit teaching that “all anesthetics be in the dispersed phase” as argued by the Applicant. While Examiner agrees that Trimble does not teach providing bupivacaine in the aqueous phase of the emulsion, the rationale to do so come from Okamoto which explicitly teaches bupivacaine in the aqueous phase of a topical anesthetic emulsion. As discussed in the above rejections, “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). Regarding Applicant’s argument about removing bupivacaine from the eutectic phase of Trimble and placing it in the aqueous phase, Trimble teaches an emulsion that comprises a eutectic mixture of lidocaine, benzocaine, and tetracaine. Thus, the combination of Trimble and Okamoto does not require the removal of bupivacaine from the eutectic phase, rather it simply adds in the additional anesthetic, bupivacaine, into the aqueous phase as taught by Okamoto.
Applicant argues that the Office fails to present any technical evidence that bupivacaine can exist in the aqueous phase while benzocaine and lidocaine simultaneously exist as a eutectic mixture in the dispersed phase (p. 5 of Remarks).
It is not the responsibility of the Office to present technical evidence that the invention is possible, rather that the invention is obvious in view of the prior art and one of ordinary skill in the art would have had a reasonable expectation of success in providing it. Both Trimble and Okamoto teach topical anesthetic emulsions in the same field of art, they provide no teachings against one another, nor are benzocaine, lidocaine, and bupivacaine known to contradict each other. Thus, one of ordinary skill in the art would be reasonably successful given the teachings of Trimble and Okamoto in adding bupivacaine to the aqueous phase of the Trimble emulsion.
Applicant argues that the previously cited hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer of Trimble is not a block copolymer comprising hydrophobic and hydrophilic blocks (p. 5 of Remarks).
This argument is moot given the teachings of Sundberg above.
Applicant argues that Ogata addresses patches and therefore bears no relevance to the presently claimed anesthetic emulsion (p. 6 of Remarks).
Ogata teaches eutectic mixtures of anesthetics that are topically administered. Given that the instant invention and Trimble relate to eutectic mixtures of anesthetics which are topically administered, the teachings of Ogata are relevant to the instantly claimed art regardless of the specific formulation.
With respect to Jun, Applicant argues that (i) Trimble discloses a ternary eutectic mixture; (ii) Jun and Okamoto are non-eutectic mixtures while Trimble employs eutectic mixtures; and (iii) Jun only combines menthol with a single anesthetic (p. 7 of Remarks).
In response to these arguments, it is established above that the instant claims do not limit the eutectic mixture to only lidocaine, benzocaine, and menthol since the term “comprising” is still recited. The fact that Jun and Okamoto teach non-eutectic mixtures does not discredit their teachings, especially given that they teach anesthetic emulsions that are topically applied for pain relief. As discussed above, menthol beneficially depresses the melting point of lidocaine, thereby increasing the lidocaine concentration in the oil phase which leads to improve transdermal absorption and efficacy as taught by Jun. While menthol is only explicitly taught to benefit lidocaine, such a teaching provides motivation to include the menthol in any anesthetic emulsion which comprises lidocaine in the oil phase, such as that of Trimble. Additionally, the instant specification defines an eutectic mixture as a mixture of two or more components which usually do not interact to form a new chemical compound but, which at certain ratios, inhibit the crystallization process of one another resulting in a system having a lower melting point than either of the components. Therefore, although Jun does not explicitly teach an eutectic mixture, the ability of menthol to depress the melting point of lidocaine would reasonably lead one of ordinary skill in the art to formulated it into a eutectic mixture comprising anesthetics such as lidocaine where the goal is to lower a systems melting point.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616