DETAILED ACTION
Status of the Claims
Claims 1-9, 11 and 12 are pending in the instant application. Claims 1-8 have been withdrawn based upon Restriction/Election. Claims 9, 11 and 12 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
Applicant claims priority to KR 10-2022-0021275 filed 02/18/2022. The U.S. effective filing date has been determined to be 02/17/2023, the filing date of the instant application. Applicant's claim for a priority date of, 02/18/2022, the filing date of document KR10-2022-0021275, is acknowledged, however no English translation of the foreign priority document has been provided for the examiner to verify 112(a) support therein.
Information Disclosure Statement
The information disclosure statements submitted on 01/13/2026 was filed after the mailing date of the first office action on the merits however Applicants have made a statement under 37 CFR 1.97(e)(2). The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over KIM (WO 2020/222399 A1; published 05/11/2020; US 2022/0202894 relied on as English language translation and cited herein) in view of Allison (“Analysis of initial burst in PLGA microparticles,”2008, Informa Healthcare, Expert Opinion Drug Delivery, Vol. 5, No. 6, pp. 615-628; of record as cited by Applicant on 07/07/2025 – Non-Patent Literature document Citation No. 2).
Applicants Claims
Applicant claims a method for preparing a composition for sustained-release injection comprising deslorelin, the method comprising preparing a first mixture by mixing deslorelin and a biodegradable polymer; preparing a second mixture by dissolving a surfactant in a solvent; injecting the first mixture and the second mixture into a first microchannel and a second microchannel, respectively, the first microchannel and the second microchannel having an intersection point therebetween, and allowing the first mixture and the second mixture to flow through the first microchannel and the second microchannel, respectively, to produce microparticles at the intersection point; collecting the microparticles in a water tank containing the second mixture; removing an organic solvent present in the microparticles collected in the water tank; washing the microparticles with purified water and drying the microparticles that are washed with the purified water; and wherein a value according to a following Equation 1 is 1-10: Cmax(1d-28d)/Cmax(0-1d), where the composition for sustained release injection comprising deslorelin is administered as an injection product to measure a blood concentration of deslorelin, Cmax(1d-28d) is a maximum blood concentration of deslorelin within 1 to 28 days after injection the injection product, and Cmax(0-1d) is a maximum blood concentration of deslorelin within 1 day after injecting the injection product, wherein when the first mixture is injected into the first microchannel, the first mixture is injected under a pressure of 700 to 1,500 mbar, the pressure is increased by a first condition of 10 to 30 mbar/min, and when the pressure reaches 900 to 1,700 mbar, the pressure is increased by a second condition to 2 to 8 mbar/min, such that the first mixture flows in the first microchannel at a constant flow rate (instant claim 9).
Determination of the scope
and content of the prior art (MPEP 2141.01)
KIM teaches sustained-release microparticles containing deslorelin, and a preparation method therefor, as discussed above and incorporated herein by reference.
KIM teaches that: “At this time, when injected into the channel in a linear direction, the first mixture is injected under a constant pressure condition and allowed to flow at a constant flow rate, and at this time, the pressure condition is 200 to 2,000 mbar, preferably 1,100 mbar, but is not limited thereto.” ([0060]). And that: “Also, when injected into the microchannel in either side or one side, the second mixture is injected under a constant pressure condition and allowed to flow at a constant flow rate, and at this time, the pressure condition is 500 to 2,400 mbar, preferably 2,200 mbar, but is not limited thereto.” ([0061]). KIM teaches that: “That is, in order to make the flow of the second mixture forming a cross-point with the flow of the first mixture faster than that of the first mixture injected into the channel in the linear direction, the second mixture is allowed to flow under a higher pressure condition.” ([0062]). And that: “As described above, by varying the flow rates of the first mixture and the second mixture, and making the flow rate of the second mixture faster than that of the first mixture, the second mixture having a relatively faster flow rate compresses the first mixture at the point where the flow of the first mixture meets the flow of the second mixture and at this time, due to the repulsive force of the first mixture and the second mixture, the biodegradable polymer and the deslorelin in the first mixture generate spherical microparticles, and more specifically, the microparticles in which the deslorelin is evenly distributed in the spherical biodegradable polymer, are formed.” ([0063]).
Regarding instant claim 12, KIM teaches that: “The step is, after the step of collecting the microparticles, a step of stirring the microparticles collected in the water bath, the microparticles are stirred under a constant temperature condition and at a stirring speed to evaporate and remove the organic solvent present on the surface of the microparticles. At this time, the step of stirring microparticles is performed in the order of: a first stirring step under the stirring conditions of a speed of 200 to 600 rpm for 0.5 to 2 hours at 15 to 25° C.; after the first stirring step, a second stirring step under the stirring conditions of a speed of 200 to 800 rpm for 2 to 6 hours at 30 to 50° C.; and after the second stirring step, a third stirring step under the stirring conditions of a speed of 200 to 800 rpm for 0.5 to 1.5 hours at 15 to 25° C.” ([0070]). And that: “As the stirring process is performed by varying the stirring speed and temperature conditions for stirring the microparticles, the evaporation speed of the organic solvent present on the surface of the microparticles may be regulated. That is, by evaporating the organic solvent present on the surface of the microparticles through the stirring process, it is possible to remove the harmful solvent and prepare microparticles having a smooth surface.” ([0071]).
KIM further teaches that: “Although the preferred embodiments of the present
disclosures have been described in detail above, the scope of the present disclosure is not limited thereto, and various modifications and improvements by those skilled in the art using the basic concept of the present invention defined in the following claims also belong to the scope of rights of the present disclosure.” ([0019]).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of KIM is that KIM does not expressly teach “when the first mixture is injected into the first microchannel, the first mixture is injected under a pressure of 700 to 1,500 mbar, the pressure is increased by a first condition of 10 to 30 mbar/min, and when the pressure reaches 900 to 1,700 mbar, the pressure is increased by a second condition to 2 to 8 mbar/min, such that the first mixture flows in the first microchannel at a constant flow rate.” (instant claim 9); or “wherein the removing of the organic solvent includes: performing primary stirring at a speed of 100 to 300 rpm for 20 to 40 minutes at 15 to 20 °C; performing secondary stirring at a speed of 100 to 300 rpm for 60 to 120 minutes at 30 to 40 °C; and performing tertiary stirring at a speed of 100 to 300 rpm for 4-8 hours at 40 to 45 °C (instant claim 12).
KIM clearly teaches “varying the flow rates of the first mixture and the second mixture” to generate “microparticles in which the deslorelin is evenly distributed in the spherical biodegradable polymer” ([0063]), and teaches pressures that overlap with the claimed pressures (the pressure condition is 200 to 2,000 mbar, preferably 1,100 mbar – the first mixture)([0060])( the pressure condition is 500 to 2,400 mbar, preferably 2,200 mbar – the second mixture)([0061]). And specifically teaches that: “At this time, when injected into the channel in a linear direction, the first mixture is injected under a constant pressure condition and allowed to flow at a constant flow rate, and at this time, the pressure condition is 200 to 2,000 mbar, preferably 1,100 mbar, but is not limited thereto.” [emphasis added]([0060]). And that: “Also, when injected into the microchannel in either side or one side, the second mixture is injected under a constant pressure condition and allowed to flow at a constant flow rate, and at this time, the pressure condition is 500 to 2,400 mbar, preferably 2,200 mbar, but is not limited thereto.” [emphasis added]([0061]). Therefore it would have been prima facie obvious to optimize the “pressure condition” and “flow rates of the first mixture and the second mixture” to generate “microparticles in which the deslorelin is evenly distributed in the spherical biodegradable polymer” (instant claim 10). The examiner argues that one of ordinary skill would have recognized that the pressure necessarily has an initial zero pressure, and must be increased to the desired working pressure. It would have been prima facie obvious to increase the pressure at a faster rate initially and slower rate as the desired working pressure is approached so as to achieve the desired constant flow rate. Therefore, the prior art implicitly discloses at least a gradually increasing pressure by describing “a constant flow rate” (MPEP §2144.01).
The instant Specification discloses that: “Specifically, in a preparation method using the microchannel, when the flow rates of the first mixture and the second mixture flowing through the microchannel are set to constant values using a flowmeter and the pressure is measured through feedback control, it is confirmed that the pressure required to flow the first mixture through the microchannel at a constant flow rate is gradually increased with time.” [emphasis added](, p. 21, [00140]; [0130], as published). And that: “Therefore, a method of constantly increasing the pressure applied to the first mixture may be used to minimize the flow rate variability, prevent the problem of microparticle distribution nonuniformity or channel closure due to slow curing of the first mixture inside the microchannel, and increase the target preparation yield of the microparticles.” (p. 22, [00141]; [0131]). KIM clearly teaches “constant flow rate” as a feature of their invention ([0060] & [0061]), and the further teaches “Another object of the present invention is to provide sustained-release microparticles having a uniform diameter” ([0015], as published). It would have been within the ordinary level of skill to increase the pressure of the first mixture injected into the first microchannel to achieve a “constant flow rate” and to prevent channel closure while producing sustained-release microparticles having a uniform diameter, as per the teachings of KIM, and consistent with the instant Disclosure.
KIM clearly teaches “varying the stirring speed and temperature conditions for stirring the microparticles” thereby “evaporating the organic solvent present on the surface of the microparticles through the stirring process, it is possible to remove the harmful solvent and prepare microparticles having a smooth surface.” ([0071]). And that: “The step is, after the step of collecting the microparticles, a step of stirring the microparticles collected in the water bath, the microparticles are stirred under a constant temperature condition and at a stirring speed to evaporate and remove the organic solvent present on the surface of the microparticles. At this time, the step of stirring microparticles is performed in the order of: a first stirring step under the stirring conditions of a speed of 200 to 600 rpm for 0.5 to 2 hours at 15 to 25° C.; after the first stirring step, a second stirring step under the stirring conditions of a speed of 200 to 800 rpm for 2 to 6 hours at 30 to 50° C.; and after the second stirring step, a third stirring step under the stirring conditions of a speed of 200 to 800 rpm for 0.5 to 1.5 hours at 15 to 25° C.” ([0070]). The first two steps (5-1 and 5-2) overlap with Applicants claimed stirring speed, time and temperature, the difference is the third step (5-3) the stirring speed, time and temperature are within the scope of the second step of KIM (5-2). And given that raising the temperature implicitly includes temperatures below the final temperature (e.g. to raise the temperature to 45 °C from 15-20 °C, necessarily includes raising the temperature through 30-40 °C), and given that KIM teaches “varying the stirring speed and temperature conditions for stirring the microparticles” thereby “evaporating the organic solvent present on the surface of the microparticles through the stirring process, it is possible to remove the harmful solvent and prepare microparticles having a smooth surface.”, it would have been prima facie obvious to optimize the stirring speed, time and temperature in order to produce microparticles having a smooth surface.
KIM does not disclose: “a value according to the following Equation 1 is 1 to 10: Cmax 1d-28d/Cmax 0-1d wherein, when the composition is administered as an injection product to measure a blood concentration of the deslorelin, Cmax 1d-28d denotes a maximum blood concentration of the deslorelin within 1 to 28 days after injecting the injection product, and Cmax 0-1d denotes a maximum blood concentration of the deslorelin within 1 day after injecting the injection product.” (instant claim 9). However, the method of making recited in claim 1 is identical to that of KIM therefore the results would have been the same (MPEP §2112).
Further Regarding Equation 1 as recited in instant claim 9, the prior art does not teach this equation, however, it would have been prima facie obvious to optimize a composition of deslorelin PLA/PLAG microparticles to minimize burst release. Particularly, ALLISON teaches that: "A major problem encountered in microparticle product development has been the inability to reproducibly control the initial burst release of drug." And further that: "In any case, excessive burst is wasteful, in that drug lost in the burst phase is not available for later release. A candidate product with burst release levels that are not reproducible from batch to batch will not be approvable. Accordingly, the goal of most efforts to control burst release is to minimize or eliminate burst entirely." [emphasis added](p. 615, §Introduction, 1st paragraph).
ALLISON teaches factors affecting burst release from PLGA microparticles (see whole document, particularly pp. 615-617), and particularly that: "Higher molecular weight polymers have increased free volume, which may contribute to
higher burst release. Drug that is dissolved in the polymer matrix occupies this space and increases the free volume of the matrix. Higher loading of drugs that are miscible with PLGA therefore increases the initial diffusion coefficient of encapsulated drug, resulting in increased burst." (p. 617, §2.2, 1st paragraph), and further that: "A high initial solvent volume is necessary to control polymer phase viscosity to allow particle formation in the desired small size range, using accessible dispersing technologies. As solvent is removed from the polymer solution, droplet volume decreases. In addition to volume loss as solvent is removed, the polymer also solidifies in a composition-dependent manner. The rate at which solvent is removed from the oil droplet determines the degree to which the droplet shrinks as the polymer hardens. The relative rates of oil droplet shrinkage and polymer hardening can lead to differences in the polymer matrix density in finished microparticles. For example, if the polymer remains in a mobile, rubbery state until the solvent is fully removed (i.e., by slow solvent removal at temperatures above the composition- dependent polymer Tg), the polymer can anneal more completely during processing. The resulting microparticles will have maximum density, with minimum process- induced free volume. Conversely, more rapid solvent extraction can lead to lower density polymer matrices and higher burst release because microparticles harden in a more solvent-swollen state. This is supported by the observation that burst release has been shown to correlate inversely with formulation bulk density." (p. 615, 1st paragraph last two lines). ALLISON teaches that: "Burst release depends on a number of factors related to the physical properties of the microsphere system components and also on the conditions encountered during processing. Recent developments in understanding the mechanisms that underlie burst release have allowed the development of strategies to control burst. In general, the methods fall into several general categories: improving the miscibility of drug in the polymer phase, increasing the resistance to diffusion (coatings) and manipulation of processing methods to control or reduce microparticle porosity." (p. 619, §Strategies to control burst release).
ALLISON teaches that: "While the initial burst release of drug is not always detrimental, excessive drug release in the burst phase may be toxic, and irregularity in the amount of drug released (e.g., from batch to batch) is not acceptable." (abstract, lines 4-6).
ALLISON teaches that: "The link between microparticle processing conditions, particle structure and burst is becoming more predictable with the increased application of statistical approaches to formulation development." (p. 623, §Conclusion, lines 3-6). ALLISON teaches that: "Processing conditions can be adjusted to alter microparticle structure and burst release, and in situ annealing of microparticles is an effective strategy to limit burst release." (p. 623, §Expert Opinion, 1st paragraph, last four lines).
ALLISON teaches that: "Viscosity during processing is increased, reducing the tendency of drug to diffuse out of nascent microparticles. [...] Encapsulation efficiency increased and burst was reduced because of the higher initial viscosity, more rapid particle hardening and increased density/reduced porosity of the polymer matrix." (p. 622, col. 1, 2ⁿᵈ paragraph, lines 9-11 & 20-23). And that: "For example, an increase in temperature will increase mass transport rates but will also reduce viscosity and may reduce the capacity of an extraction liquid for the organic solvent." (p. 622, col. 1, 3ʳᵈ paragraph, lines 9-11).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 vary the parameters for flow rates and pressure for the injecting and to vary the stirring speed and temperature conditions for stirring the microparticles in the step of removing the organic solvent, as suggested by KIM, in order to generate “microparticles in which the deslorelin is evenly distributed in the spherical biodegradable polymer” and to “prepare microparticles having a smooth surface”, respectively as taught by KIM, the method of making recited in claim 1 is identical to that of KIM therefore the resulting initial burst release would have been the same (MPEP §2112), alternatively, one of ordinary skill would have optimized the process conditions to achieve a low initial burst release as suggested by Allison, the examiner notes that Equation 1 of instant claim 9 clearly implies a low initial burst release.
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 because it would have required no more than an ordinary level of skill to vary the parameters taught by KIM within the scope taught for those parameters in order to produce the microparticles described therein. Therefore, the invention as a whole would have been 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.
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(a).
Response to Arguments:
Applicant's arguments filed 11/05/2025 have been fully considered but they are not persuasive.
Applicant argues that: “First, Applicant respectfully submits that none of the cited references discloses the claimed feature, "when the first mixture is injected into the first microchannel, the first mixture is injected under a pressure of 700 to 1,500 mbar, the pressure is increased by a first condition of 10 to 30 mbar/min, and when the pressure reaches 900 to 1,700 mbar, the pressure is increased by a second condition of 2 to 8 mbar/min," as recited in amended claim 9.” (p. 8). And that: “Here, paragraphs [0130]-[0131] of the published specification of the instant application, reproduced below as a non-limiting example, state that the pressure required to flow the first mixture through the microchannel at a constant flow rate is gradually increased over time and, as such, increasing the pressure applied to the first mixture is necessary to minimize the flow rate variability. In other words, instant application recognizes increasing the pressure by the first condition of amended claim 9 as a result-effective variable to maintain the constant flow rate of the first mixture in the first microchannel.” (paragraph bridging pp. 8-9)[emphasis added].
In response the examiner argues that KIM clearly teaches that “At this time, when injected into the channel in a linear direction, the first mixture is injected under a constant pressure condition and allowed to flow at a constant flow rate, and at this time, the pressure condition is 200 to 2,000 mbar, preferably 1,100 mbar, but is not limited thereto.” [emphasis added]([0060]). And that: “Also, when injected into the microchannel in either side or one side, the second mixture is injected under a constant pressure condition and allowed to flow at a constant flow rate, and at this time, the pressure condition is 500 to 2,400 mbar, preferably 2,200 mbar, but is not limited thereto.” [emphasis added]([0061]). The instant Application discloses that: “it is confirmed that the pressure required to flow the first mixture through the microchannel at a constant flow rate is gradually increased with time.” which clearly suggest that to achieve a constant flow rate for the first mixture, as described by KIM, the pressure of the first mixture flow rate is gradually increased with time. It would have been prima facie obvious to increase the flow rate initially at a faster rate from zero in order to reach the desired pressure faster, and then to increase at as slower rate to achieve a constant flow rate, as described by KIM. The examiner acknowledges that KIM teaches “a constant pressure condition” however KIM also teaches “a constant flow rate” is achieved for the first mixture which Applicants disclosure that: “it is confirmed that the pressure required to flow the first mixture through the microchannel at a constant flow rate is gradually increased with time” suggests a gradually increasing pressure is required to achieve a constant flow rate. Therefore, the prior art implicitly discloses at least a gradually increasing pressure by describing “a constant flow rate” (MPEP §2144.01).
Applicant further argues that: “Second, Applicant respectfully submits that none of the cited references discloses the claimed feature, "wherein a value according to a following Equation 1 is 1 to 10: [Equation 1] Cmax ld-28d/Cmax 0-ld where, the composition for sustained-release injection comprising deslorelin is administered as an injection product to measure a blood concentration of deslorelin, Cmax ld-28d is a maximum blood concentration of deslorelin within 1 to 28 days after injecting the injection product, and Cmax 0-ld is a maximum blood concentration of deslorelin within 1 day after injecting the injection product," as recited in amended claim 9. And further that: “Applicant respectfully submits that claim 9 thus amended is further distinguished from the method of Kim and that Kim cannot inherently disclose the claimed feature regarding the [Equation l].” (p. 10, lines 5-7).
In response the examiner argues that the limitation of claim 10, is fairly implied by KIM teaching a constant flow rate, and therefore maintains that the result would have been the same. Alternatively, one of ordinary skill would have optimized the process conditions to achieve a low initial burst release as suggested by Allison, the examiner notes that Equation 1 of instant claim 9 clearly implies a low initial burst release.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 9, 11 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,251,419 (hereafter ‘419) in view of Allison (“Analysis of initial burst in PLGA microparticles,”2008, Informa Healthcare, Expert Opinion Drug Delivery, Vol. 5, No. 6, pp. 615-628; of record as cited by Applicant on 07/07/2025 – Non-Patent Literature document Citation No. 2).
Instant claims are discussed above.
‘419 claim 1 recites a method for preparing sustained-release microparticles
containing deslorelin, the method comprising steps of: (1) preparing a first mixture by mixing an active pharmaceutical ingredient (API) mixture in which deslorelin is dissolved in a first solvent and a biodegradable polymer mixture in which a biodegradable polymer is dissolved in a second solvent; (2) dissolving a surfactant in water to prepare a second mixture; (3) injecting the first mixture of the step (1) into a channel in a linear direction and allowing the first mixture to flow therein; (4) injecting the second mixture of the step 2) into a channel formed on either side or one side so as to form a cross-point with the channel in which the first mixture of the step (3) flows in the linear direction and allowing the second mixture to flow therein, and then crossing the flow in the linear direction with the flow in a lateral direction to prepare microparticles in which deslorelin is evenly distributed; (5) collecting the microparticles generated at the crosspoint of the step (4); (6) removing an organic solvent present on the surface of the microparticles collected in the step (5); and (7) washing and drying the microparticles of the step 6), wherein the prepared microparticles are an […] emulsion or a […] emulsion, and have an average diameter of 25 to 140 μm.
The difference between the instantly rejected claims and the claims of ‘419 is that the claim of ‘419 do not expressly claim the specific release profile (Cmax1d-28d/Cmax0-1d value of Equation 1 “when the first mixture is injected into the first microchannel, the first mixture is injected under a pressure of 700 to 1,500 mbar, the pressure is increased by a first condition of 10 to 30 mbar/min, and when the pressure reaches 900 to 1,700 mbar, the pressure is increased by a second condition to 2 to 8 mbar/min, such that the first mixture flows in the first microchannel at a constant flow rate.” (instant claim 9); or “wherein the removing of the organic solvent includes: performing primary stirring at a speed of 100 to 300 rpm for 20 to 40 minutes at 15 to 20 °C; performing secondary stirring at a speed of 100 to 300 rpm for 60 to 120 minutes at 30 to 40 °C; and performing tertiary stirring at a speed of 100 to 300 rpm for 4-8 hours at 40 to 45 °C (instant claim 12). However, it would have been within the ordinary level of skill in the art to vary the parameters of ‘419 claim 1 to produce the best possible deslorelin microparticles having the deslorelin distributed throughout and having a smooth surface on spherical particles.
Allison teaches minimizing initial burst release, as discussed above and incorporated herein by reference.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of ‘419 because it would have been prima facie to optimize the parameters of claim 1. The skilled artisan would have been motivated to modify the claims of ‘419 and produce the instantly rejected claim to produce the best to produce the best possible deslorelin microparticles having the deslorelin distributed throughout and having a smooth surface on spherical particles with a low burst release, as suggested by Allison. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill in the art to which the invention pertains to vary the parameters of ‘419 claim 1 to produce the best possible deslorelin microparticles.
Conclusion
Claims 9, 11 and 12 are pending and have been examined on the merits. Claims 9, 11 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,251,419. No claims allowed at this time.
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 IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619