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 .
Applicant Response
Applicant's response, filed 06/02/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Terminal Disclaimer
The terminal disclaimer filed on 01/02/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of prior patent No. 11,441,994 B2 has been reviewed and was accepted in the office action mailed 03/03/2026. The terminal disclaimer has been recorded.
The terminal disclaimer filed on 01/02/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of prior patent No. 11,488,686 B2 has been reviewed and was accepted in the office action mailed 03/03/2026. The terminal disclaimer has been recorded.
Claim Status
Claims 2-6, 8-12, and 14-20 are cancelled.
Claims 21-26 are newly added.
Claims 1, 7, 13, and 21-26 are pending and under examination herein.
Claims 1, 7, 13, and 21-26 are rejected.
Priority
The instant application claims the benefit of foreign priority to 202021007335, filed 02/20/2020. As such, the effective filing date assigned to each of claims 1, 7, 13, and 21-26 is 02/20/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings filed 12/29/2020 were accepted by the examiner in the office action mailed 02/19/2025.
Claim Interpretation
Under the broadest reasonable interpretation of the claims based on the title, abstract, drawings and specification, the steps in the claims are interpreted to be a simulation.
Claim Objections
The objections to claims 7 and 13 are withdrawn in view of the claim amendment filed 06/02/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant disclosure does not provide written description for adjusting at least one transport property of the multiscale model based on a comparison between the calculated flux profile. This rejection is newly recited and necessitated by claim amendments.
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.
Claims 21-26 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. This rejection is newly recited and necessitated by claim amendments.
Claims 21-23 recites the limitation "the processor implemented method". There is insufficient antecedent basis for this limitation in the claim, as this claim is not written as dependent on any other claims. Similarly, there is insufficient antecedent basis for the limitations of “the one or more pulse parameters” in claim 21, “the molecular dynamics simulation” in claim 22, and “the multiscale model” and “ the calculated flux profile” in claim 23. For the purposes of examination, these claims are interpreted to be dependent from claim 1.
Claims 24-26 recites the limitation "the system". There is insufficient antecedent basis for this limitation in the claim, as this claim is not written as dependent on any other claims. Similarly, there is insufficient antecedent basis for the limitations of “the one or more pulse parameters” in claim 24, “the molecular dynamics simulation” in claim 25, and “the multiscale model” and “ the calculated flux profile” in claim 26. For the purposes of examination, these claims are interpreted to be dependent from claim 7.
Furthermore, there is insufficient antecedent basis for the limitations of “updating the pulse parameters” in claims 21 and 24, as the claim recites “tuning the one or more pulse parameters”, and does not require more than one pulse parameter. For the purpose of examination, this limitation is interpreted as “updating the one or more pulse parameters”.
Claim Rejections - 35 USC § 101
The rejections of claims 1, 7 and 13 under 35 U.S.C. 101 were withdrawn in the office action mailed 06/02/2026 in view of the claim amendments filed 01/02/2026, as it does not appear that the combination of additional elements recited in the independent claims was well-known, routine or conventional (WURC) in the art at the effective filing date of the instant application. Specifically, it was not WURC to calculate both an active and passive diffusion coefficient using a MD technique which integrates simulations at molecular and macroscopic levels and test the electroporation model against data on fentanyl permeation under the applied electric field, wherein in a virtual testing of active permeation through skin in the presence of an external electric field is performed as described in the instant claims. Furthermore, with respect to claim 7 and 13, it is further not WURC to perform full factorial design simulation for four different voltages and three pulse durations for the given number of pulses, as disclosed in the instant claims. Claims 21-26 also appear to be free from a rejection 35 U.S.C. 101 for the reasons discussed above.
.
Claim Rejections - 35 USC § 103
The rejections of claims 6, 12, and 18-20 under 35 U.S.C. 103 are withdrawn in view of cancelation of the claims in the claim amendment filed 06/02/2026.
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, 13, and 21-26 remain rejected under 35 U.S.C. 103 as being unpatentable over Gupta and Rai (Langmuir 2018 34 (20), 5860-5870; ; previously cited; hereafter referred to as Gupta), and further in view of Gupta et al. (US20180253525A1; previously cited) and Becker (International journal of thermal sciences 2012, 54, pp.48-61; previously cited). Newly recited portions are necessitated by claim amendments.
With respect to claims 1, 7, 13, 21, and 24, Gupta discloses molecular dynamics simulation, in which they obtain an equimolar model to mimic the skin Stratum Corneum (SC) lipid bilayer (p 5861, col 2, para 4).
Gupta further discloses direct application of the electric field along the lipid bilayer method to capture the electroporation of the skin SC lipid bilayer, and that pore formation occurs after a certain critical electric field, also known as the threshold field (p 5862, col 1, para 4-col 2, para 1).
Gupta also discloses water pore stabilization and that to stabilize the water pore, the electric field was reduced significantly, once the pore radius almost reached to ∼3−4nm (p 5863, col 2, para 2).
Gupta also discloses performing simulation of drug molecule permeation in the presence of an external electric field by manually inserting four benzoic acid (drug) molecules into a lipid bilayer with a stable pore (p 5866, col 2, para 2-p 5867, col 1, para 1; fig 6).
Gupta further discloses using the obtained model to simulate the structure of the SC layer, comprising corneocytes interconnected by a lipid lamellar bilayer structure in a crystalline−gel phase at both a molecular and coarse-grained, in which the corneocytes and lipid matrix are arranged in a brick and mortar fashion, respectively (i.e. micro- and macroscopic level) (p 5861, col 2, para 4). Gupta also discloses performing the extensive atomistic MD simulation of the skin lipid bilayer in the presence of varying external electric fields (p 5861, col 2, para 4-p 5868, col 1, para 1).
Gupta discloses performing four separate electroporation simulations were performed at each electric field at different durations to tune the parameters (p 5862, col 1, para 4-p 5867, col 2, para 3; Table S1-S3). It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have performed full factorial design simulation for four different voltages and three pulse durations for the given number of pulses until a desired endpoint is reached through routine experimentation of the voltage and pulse durations within the prior art conditions of tuning the parameters through the performance of electroporation simulations. See MPEP 2144.05 II. A..
Gupta further suggests the use of simulations with experiments, such as full-factorial design simulations with different voltages and varying pulse durations could be used for better design of experiments, and that for a given skin composition and size of the drug molecule, the combination of pore formation time and pore growth rate can be used to know a priori the desired electric field and time for the application of the electric field (p 5866, col 2, para 2-p5867, col 2, para 3).
Gupta further discloses the provided molecular mechanism could help in optimizing/designing the electroporation experiments for better drug delivery (p 5868, col 1, para 2). Therefore, Gupta suggests selecting one or more electroporation protocols.
However, with respect to claims 1, 7 and 13, Gupta does not disclose calculating passive and active diffusion coefficients of drug molecules through the stable pore, calculating the concentration gradient of the drug molecules in the presence of the electric potential using a FEA technique and the diffusion coefficients, calculating the drug profiles or drug release profiles using the concentration coefficient, testing the molecular electroporation model against data on fentanyl permeation under the applied electric field, validating the multiscale model using experimental permeation data. tuning one or more pre-defined pulse parameters based on the calculated flux profile and the calculated cumulative release profile.
However, with respect to claims 1, 7 and 13, the prior art to Gupta et al., in the same field of endeavor, discloses method and system for in-silico testing of actives on human skin, in which a micro and macroscopic level model of the structure of the skin’s upper layer (i.e. SC layer) is provided and used in a multi-scale modeling framework for the calculation of diffusion and release profile of different actives like drugs, particles and cosmetics through developed skin model using molecular dynamics simulations and computational fluid dynamics approach (abstract; claim 1l para 0027).
Gupta et al. discloses constrained molecular dynamics simulation is used for the calculation of diffusion coefficient or diffusivity of the active molecule (i.e. passive diffusion coefficient of one or more drug molecules) (para 0033).
Gupta et al. discloses calculated diffusion coefficient can further be used to predict the dermal uptake/ cumulative release through the stratum corneum using computational fluid dynamics techniques (para 0007).
Gupta et al. discloses the averaged diffusion coefficient along the bilayer normal is further used as an input to the transport model, which is configured to generate the release profile of the actives, and that a finite element technique (FBM) is used to solve the transport model (para 0034).
Gupta et al. further discloses the flux across the SC is measured and integrated with respect to time to calculate the dermal uptake/cumulative release of permeate through SC (para 0035)
Gupta et al. further discloses the measurement of the diffusion coefficient of the molecules in stratum corneum is very important in order to predict the transport mechanism and that studying the transport mechanism of molecules through skin is necessary in order to design a new molecule/drugs/cosmetic (para 0004).
Gupta et al. also discloses performing simulations to test the model using experimental data on fentanyl permeation (para 0058-0067).
Gupta et al. further discloses the method of in-silico testing of actives using simulations of human skin were validated with the help of following experimental findings and validating the release profile of the actives with an experimental release profile of the actives (para 0038-para 0067).
With respect to claims 22-23 and 25-26, Gupta et al. discloses it has been shown previously that solute size and composition changes the permeability many folds as well as local partition function governs the solute permeability, and the developed multi-scale modeling framework could be used for the screening/testing of any drug/cosmetic/biomolecules etc. on skin SC, and that flux across the SC is measured and integrated with respect to time to calculate the dermal uptake/cumulative release of permeant through SC, suggesting repeating the molecular dynamics simulation for the one or more drugs to compute corresponding diffusion coefficients to enable drug-specific electroporation protocol selection and adjusting the transport property of the multiscale model based on a calculated flux profile (para 0045-0067).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the molecular dynamics simulation described by Gupta with the steps of determining a passive diffusion coefficient and calculating the drug flux, release profile and testing the simulation against experimental data as described by Gupta et al., because the measurement of the diffusion coefficient of the molecules in stratum corneum is very important in order to predict the transport mechanism and that studying the transport mechanism of molecules through skin is necessary in order to design a new molecule/drugs/cosmetic, as disclosed by Gupta. There would be a reasonable expectation of success because determining the diffusion coefficient of molecules would not impede the simulation of Gupta.
However, Gupta et al. does not disclose calculating the active diffusion coefficient (i.e. the diffusion coefficient across the stable pore), calculating the diffusion coefficient of a drug molecule in the presence of an electric potential, using this gradient to determine the drug flux and cumulative release profiled, or tuning the parameters to obtain a desired release profile.
However, with respect to claims 1, 7 and 13, the prior art to Becker, in the same field of endeavor, discloses computationally modeling and treatment of mass transport associated with electroporation of the skin, which is computer implemented (as evidenced by the use of programming language Fortran (abstract; p 54, col 2, para 3; p 59, col 2, para 2).
Becker discloses, modeling a composite description of skin including the lipid bilayer of a SC layer (fig 1; p 50, col 2, para 4; fig 3).
Becker discloses applying an electric pulse, which results in the development of Local Transport Regions (LTR) (i.e. pore) and determining the electric field required for (LTR (p 48, col 2, para 1; p 50, col 1, para 3-col 2, para 2; p 51, col 2, para 1-3).
Becker further discloses estimating transport coefficients, such as the diffusion coefficient, and modeling the transient transport of a large charged solute in the presence of an electric field (i.e. active diffusion through a pore) (abstract; sections 2.2 and 2.6). Becker discloses considering both passive and active diffusion models (p 50, col 2, para 2; section 2.5).
Becker also discloses the model of the SC includes the macroscopic structure, which includes the understanding that that the SC is composed of lamellar lipid sheets set between corneocytes (p 50, col 1, para 2-col 2, para 2).
Becker discloses modeling calculating a transient transport of a charged solute in the presence of an electric field in the LTR (i.e. concentration gradient), using transport coefficients, such as the diffusion coefficient and electrophoretic mobility, porosity, lipid melt fraction, etc., using the Laplace equation and modified Nernst-Planck equation (i.e. uses a finite element analysis (FEA) technique) (i.e. simulation techniques takes into account both molecular and macroscopic levels) (sections 2.1-2.2, 2.4 and 2.6; equation 1-7). Becker discloses the transport model is derived from both a Laplace equation and Nernst-Planck equation (sections 2.2-2.5). The instant specification describes transport properties as diffusivity in para 047, which is captured by Becker’s transport coefficients used in the finite element analysis. Becker discloses the equations are used based on the understanding of the skin used by the molecular electroporation model, including the macroscopic structure and pre-defined pulse/temperature parameters and boundaries of the SC layer (p 50, col 1, para 3-col 2, para 2). Becker further discloses the modified Nernst-Planck equation makes use of solute concentration, effective electrophoretic mobility and effective diffusion coefficient, and further discloses using the electrical conductivity as described by the instant specification in para 0071 (p 51, col 1, para 2-col 2, para 2). Becker discloses a pre-defined pulse parameter of a pulse type (p 50, col 2, para 1).
Becker further discloses estimating the solute flux and total solute deposition and transportation (i.e. cumulative release profile) using the concentration gradient equations (p 54, col 1, para 2; fig 5-11; section 4).
Becker discloses further performing a parametric investigation (i.e. tuning) based on the solute flux and total solute deposition and transportation (section 4).
Therefore, it would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the multiscale molecular dynamics simulation described by Gupta with the steps of determining an active diffusion coefficient which takes into account passive diffusion, model the transport of solutes across the SC layer through a pore and calculate the drug flux and release profile in the presence of an electric potential as described by Becker, because skin electroporation has been shown to greatly increase the success of transdermal delivery through the SC, as disclosed by Becker, and the measurement of the diffusion coefficient of the molecules in stratum corneum is very important in order to predict the transport mechanism and that studying the transport mechanism of molecules through skin is necessary in order to design a new molecule/drugs/cosmetic, as disclosed by Gupta et al. There would be a reasonable expectation of success because determining the transport mechanisms of electroporation to determine the drug flux and release profiles would not impede the simulation of Gupta, as the simulation techniques of Becker can take into account both molecular and macroscopic levels.
Therefore, the invention is prima facie obvious.
Response to Applicant’s Arguments
Applicant states the prior art to Gupta and Becker do not disclose the amended subject matter (Applicant’s Arguments, p 12, para 1). Applicant states Becker does not disclose accounting for the molecular level picture of the SC lipids (i.e. multiscale MD simulation), which are critical for the molecular transport of the molecules, Gupta does not disclose selecting electroporation protocol, which include tuning the pulse parameters to get desired release profile for the one or more drug molecules and facilitates enhancement of drug permeation and reduction of lag time of drug permeation as disclosed by the instant claims (Applicant’s Arguments, p 12, para 2-p 15, para 1). Applicant further states that the overall technical difference between the cited prior art documents and amended independent claim 1 is (i) determining a passive diffusion coefficient of a drug molecule using molecular dynamics (MD) simulation; (ii) determining an active diffusion coefficient through an electropore in the presence of an external electric field; (iii) both diffusion coefficients into a coupled molecular-macroscopic transport model; (iv) calculating a drug flux and cumulative release profile using the coupled model, and requests withdrawal of the rejections (Applicant’s Arguments, p 15, para 2-p 16, last paragraph).
It is respectfully submitted that this is not persuasive. As discussed above, the prior art to Gupta discloses molecular dynamics simulation, in which they obtain an equimolar model to mimic the skin Stratum Corneum (SC) lipid bilayer (p 5861, col 2, para 4). Gupta further discloses using the obtained model to simulate the structure of the SC layer, comprising corneocytes interconnected by a lipid lamellar bilayer structure in a crystalline−gel phase at both a molecular and coarse-grained, in which the corneocytes and lipid matrix are arranged in a brick and mortar fashion, respectively (i.e. molecular and macroscopic level) (p 5861, col 2, para 4). Gupta also discloses performing the extensive atomistic MD simulation of the skin lipid bilayer in the presence of varying external electric fields (p 5861, col 2, para 4-p 5868, col 1, para 1).
The prior art to Gupta et al. discloses constrained molecular dynamics simulation is used for the calculation of diffusion coefficient or diffusivity of the active molecule (i.e. passive diffusion coefficient of one or more drug molecules) (para 0033). Gupta et al. discloses calculated diffusion coefficient can further be used to predict the dermal uptake/ cumulative release through the stratum corneum using computational fluid dynamics techniques (para 0007). And, the prior art to Becker further discloses estimating transport coefficients, such as the diffusion coefficient, and modeling the transient transport of a large charged solute in the presence of an electric field (i.e. active diffusion through a pore) (abstract; sections 2.2 and 2.6). Becker discloses considering both passive and active diffusion models (p 50, col 2, para 2; section 2.5).
Becker also discloses the model of the SC includes the macroscopic structure, which includes the understanding that that the SC is composed of lamellar lipid sheets set between corneocytes, and modeling and calculating a transient transport of a charged solute in the presence of an electric field in the LTR (i.e. concentration gradient), using transport coefficients, such as the diffusion coefficient and electrophoretic mobility, porosity, lipid melt fraction, etc., using the Laplace equation and modified Nernst-Planck equation (i.e. uses a finite element analysis (FEA) technique) (i.e. simulation techniques takes into account both micro- and macroscopic level) (p 50, col 1, para 2-col 2, para 2; sections 2.1-2.2, 2.4 and 2.6; equation 1-7). Becker discloses the transport model is derived from both a Laplace equation and Nernst-Planck equation (sections 2.2-2.5). Becker discloses the equations are used based on the understanding of the skin used by the molecular electroporation model, including the macroscopic structure and pre-defined pulse/temperature parameters and boundaries of the SC layer (p 50, col 1, para 3-col 2, para 2). Becker further discloses the modified Nernst-Planck equation makes use of solute concentration, effective electrophoretic mobility and effective diffusion coefficient, and further discloses using the electrical conductivity as described by the instant specification in para 0071 (p 51, col 1, para 2-col 2, para 2). Becker further discloses estimating the solute flux and total solute deposition and transportation (i.e. cumulative release profile) using the concentration gradient equations (p 54, col 1, para 2; fig 5-11; section 4).
Gupta et al. discloses constrained molecular dynamics simulation is used for the calculation of diffusion coefficient or diffusivity of the active molecule (i.e. passive diffusion coefficient of one or more drug molecules) (para 0033). Gupta et al. discloses calculated diffusion coefficient can further be used to predict the dermal uptake/ cumulative release through the stratum corneum using computational fluid dynamics techniques (para 0007). And, Becker further discloses estimating transport coefficients, such as the diffusion coefficient, and modeling the transient transport of a large charged solute in the presence of an electric field (i.e. active diffusion through a pore) (abstract; sections 2.2 and 2.6). Becker discloses considering both passive and active diffusion models (p 50, col 2, para 2; section 2.5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the multiscale molecular dynamics simulation described by Gupta with the steps of determining a passive diffusion coefficient and calculating the drug flux, release profile and testing the simulation against experimental data as described by Gupta et al., because the measurement of the diffusion coefficient of the molecules in stratum corneum is very important in order to predict the transport mechanism and that studying the transport mechanism of molecules through skin is necessary in order to design a new molecule/drugs/cosmetic, as disclosed by Gupta.
It would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the multiscale molecular dynamics simulation described by Gupta with the steps of determining an active diffusion coefficient which takes into account passive diffusion, model the transport of solutes across the SC layer through a pore and calculate the drug flux and release profile in the presence of an electric potential as described by Becker, because skin electroporation has been shown to greatly increase the success of transdermal delivery through the SC, as disclosed by Becker, and the measurement of the diffusion coefficient of the molecules in stratum corneum is very important in order to predict the transport mechanism and that studying the transport mechanism of molecules through skin is necessary in order to design a new molecule/drugs/cosmetic, as disclosed by Gupta et al.
Gupta discloses performing four separate electroporation simulations were performed at each electric field at different durations to tune the parameters (p 5862, col 1, para 4-p 5867, col 2, para 3; Table S1-S3). It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have performed full factorial design simulation for four different voltages and three pulse durations for the given number of pulses through routine experimentation of the voltage and pulse durations within the prior art conditions of tuning the parameters through the performance of electroporation simulations. See MPEP 2144.05 II. A..
Gupta further suggests the use of simulations with experiments, such as full-factorial design simulations with different voltages and varying pulse durations could be used for better design of experiments, and that for a given skin composition and size of the drug molecule, the combination of pore formation time and pore growth rate can be used to know a priori the desired electric field and time for the application of the electric field (p 5866, col 2, para 2-p5867, col 2, para 3). Gupta further discloses the provided molecular mechanism could help in optimizing/designing the electroporation experiments for better drug delivery (p 5868, col 1, para 2). Therefore, Gupta suggests selecting one or more electroporation protocols.
Therefore, the invention is prima facie obvious.
Furthermore, it is noted that the instant claims do not recite that the selected protocols needs to facilitates enhancement of drug permeation and reduce of lag time of drug permeation.
Therefore, the rejection is maintained.
Conclusion
No claims 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.
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/N.D./ Examiner, Art Unit 1686
/Karlheinz R. Skowronek/ Supervisory Patent Examiner, Art Unit 1687
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