DETAILED ACTION
Status of Claims
Claims 1-10 are currently pending. Claims 1-7 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 8-10 are withdrawn from consideration. 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 Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-7) in the response filed on February 13, 2023 (to the January 22, 2026 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claims 8-10) is withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I without traverse.
Accordingly, the January 22, 2026 Requirement for Restriction is made FINAL, and claims 1-7 are examined as follows.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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.
Claim 5 is rejected under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or, for pre-AIA , that applicant regards as the invention.
Claim 5 is drawn to:
[Claim 5] The sustained-release injectable composition according to claim 1, wherein the microparticles comprise naltrexone and the biodegradable polymer at a weight ratio of 1:1 to 1:10.
wherein the recitation, “naltrexone and the biodegradable polymer,” relating to the recited “weight ratio” is indefinite because it is unclear as to whether the ratio is “naltrexone” to “biodegradable polymer,” or vice verse. In this regard, it is noted that the Board has held: “if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (expanded panel). To the extent applicant intends the former, examiner suggest amending claim 5 to read:
[Claim 5] The sustained-release injectable composition according to claim 1, wherein the microparticles comprise naltrexone and the biodegradable polymer at a weight ratio of naltrexone to biodegradable polymer of 1:1 to 1:10.
Further clarification is required.
Claim Rejections – 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 and 3-7 are rejected under 35 U.S.C. § 103 as being unpatentable over YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”).
Yoon is directed to:
INJECTABLE LONG-ACTING NALTREXONE MICROPARTICLE COMPOSITIONS
ABSTRACT
The present disclosure relates to naltrexone sustained release microparticle delivery systems for the treatment of diseases ameliorated by naltrexone. The injectable microparticle delivery system includes naltrexone encapsulated in biodegradable microparticles administered in a pharmaceutically acceptable vehicle.
Yoon, title & abstract. Further in this regard, Yoon teaches “controlled-release (or sustained-release) naltrexone microparticle formulations comprising naltrexone and a biodegradable polymer such as poly(lactide-co-glycolide), also known as poly(lactic-co-glycolic acid) (PLGA), for longer than one month” that “can be readily injected subcutaneously or intramuscularly”:
SUMMARY OF THE INVENTION
[0013] The present disclosure relates to injectable, controlled-release (or sustained-release) naltrexone microparticle formulations comprising naltrexone and a biodegradable polymer such as poly(lactide-co-glycolide), also known as poly(lactic-co-glycolic acid) (PLGA), for longer than one month. The microparticles (microspheres) can be readily injected subcutaneously or intramuscularly. More particularly, the present disclosure relates to a method for preparing injectable microparticles having unique release profiles of naltrexone for longer than 4 weeks, preferably about 8 weeks to about 12 weeks, more preferably up to 100 days. The microparticles are prepared by solvent extraction/evaporation of an oil-in-water emulsion, the dispersed oil phase being solutions formed by using an organic solvent, including mainly of naltrexone and biodegradable, biocompatible polymer.
Yoon, par. [0013].
Regarding independent claim 1 and the requirements:
[Claim 1] A sustained-release injectable composition containing naltrexone, the composition comprising microparticles, wherein the microparticles comprise naltrexone and a biodegradable polymer and have a value of 120 to 320 as calculated by the following Equation 1:
[Equation 1]
AUCinf/Cmax
wherein
AUCinf(ng*hr/ml) is the area under the plasma concentration-time curve, obtained by administering microparticles containing naltrexone to a beagle dog by injection and measuring the plasma concentration of naltrexone, and
Cmax (ng/ml) is the maximum plasma concentration of naltrexone, measured after administering the microparticles containing naltrexone to the beagle dog by injection.
Yoon clearly teaches a “controlled-release (or sustained-release) naltrexone microparticle formulations comprising naltrexone and a biodegradable polymer such as poly(lactide-co-glycolide), also known as poly(lactic-co-glycolic acid) (PLGA), for longer than one month” that “can be readily injected subcutaneously or intramuscularly” (Yoon, par. [0013]), WHEREBY it is noted:
“naltrexone” (Yoon, par. [0013]) is “naltrexone” of claim 1;
“microparticle formulations” composed of “poly(lactic-co-glycolic acid) (PLGA)” (Yoon, par. [0013]) is a “biodegradable polymer” for “microparticles” of claim 1, as well as “polylactide-co-glycolide (PLGA)” and a “biodegradable polymer” of claim 4:
[Claim 4] The sustained-release injectable composition according to claim 1, wherein the biodegradable polymer is selected from the group consisting of polylactic acid, polylactide, polylactic-co-glycolic acid, polylactide-co-glycolide (PLGA), polyphosphazine, polyiminocarbonate, polyphosphoester, polyanhydride, polyorthoester, polycaprolactone, polyhydroxyvalate, polyhydroxybutyrate, polyamino acid, and combinations thereof.
However, Yoon DOES NOT EXPRESSLY TEACH the “AUCinf/Cmax” value of “120 to 320” as required by claim 1, or the requirements of claim 6 for:
[Claim 6] The sustained-release injectable composition according to claim 1, which, when administered by injection, releases naltrexone continuously for one month by controlling the release rate of naltrexone at a target site.
which are well within the purview of the ordinarily skilled artisan per Yoon’s broader disclosure. In this regard, dosage/amount of active ingredient is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Also, “[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); and also MPEP § 2144.05(II)(A). In the instant case, “sustained release” (Yoon, abstract) is clearly a result-effective variable since Yoon teaches “particle diameter, shape, morphology, and porosity can be manipulated in such a way to control the release characteristics and allow passage through a syringe and needle,” while “[t]he release profile may vary depending upon the L:G ratio, molecular weight, end group, and polydispersity of the biodegradable, biocompatible PLGA polymer, the residual solvent content, manufacturing methodology, among other factors” for “releasing capabilities of longer than 4 weeks, in particular, about 8 to 12 weeks (or 100 days)”:
[0036] The microparticles can be prepared in a size distribution range suitable for subcutaneous and/or intramuscular injection using needles thinner than 20 G. The particle diameter, shape, morphology, and porosity can be manipulated in such a way to control the release characteristics and allow passage through a syringe and needle. The naltrexone loaded microparticles may have a particle size distribution with the range of 1 to 200 μm. More preferably, the particle size distribution may have a range of about 10˜125 μm. Even more preferably, the particle size distribution may have a range of about 25˜100 μm. In one aspect, the microparticles have an average particle size in the range of 25 to 125 μm.
[…]
[0045] The release profile may vary depending upon the L:G ratio, molecular weight, end group, and polydispersity of the biodegradable, biocompatible PLGA polymer, the residual solvent content, manufacturing methodology, among other factors. Second, the release profile may vary between in vitro and in vivo conditions, due to such factors as temperature differences between in vitro and in vivo experiments, release media versus interstitial fluid differences, and/or vehicle used for administration.
[0046] By providing microparticles which have releasing capabilities of longer than 4 weeks, in particular, about 8 to 12 weeks (or 100 days), subjects will receive fewer injections and require less visits to physician offices. The microparticles of the present disclosure show an exemplary sustained release of naltrexone both in in vivo and in vitro conditions. To provide for better patient compliance, the size of the microparticles and/or amount of naltrexone may be modified.
(Yoon, par. [0036] & [0045]-[0046]). Therefore, it would have been customary for an artisan of ordinary skill to optimize “particle diameter, shape, morphology, and porosity” (Yoon, par. [0036]) “L:G ratio, molecular weight, end group, and polydispersity of the biodegradable, biocompatible PLGA polymer” (Yoon, par. [0045]) for release up to “longer than 4 weeks, in particular, about 8 to 12 weeks (or 100 days)” (Yoon, par. [0046]), thereby rendering the “AUCinf/Cmax” value requirements of claim 1 obvious, absent evidence to the contrary.
Thus, Yoon renders claims 1, 4 and 6 obvious.
Regarding claims 3 and 5 and the requirements:
[Claim 3] The sustained-release injectable composition according to claim 1, containing more than 240 mg to less than 310 mg of naltrexone.
[…]
[Claim 5] The sustained-release injectable composition according to claim 1, wherein the microparticles comprise naltrexone and the biodegradable polymer at a weight ratio of 1:1 to 1:10.
Yoon teaches an exemplary embodiment of mricorpparticles obtained from “500 mg of PLGA 75:25 (Resomer RG756S) and 267 mg of naltrexone free base (Tecoland Corporation, Irvine, Calif.),” i.e., a naltrexone to PLGA ratio of 1:1.87:
Example 1
[0052] Effect of PLGA 75:25 Processing
[0053] The continuous phase was prepared by weighing 40 g of poly(vinyl alcohol) (PVA) (Mowiol 40-88, Sigma Aldrich, St. Louis, Mo.) and mixing with 4 L of deionized water. The organic phase consisted of 500 mg of PLGA 75:25 (Resomer RG756S) and 267 mg of naltrexone free base (Tecoland Corporation, Irvine, Calif.) dissolved in 1.333 g of dichloromethane (DCM) (Fisher Scientific, Fair Lawn, N.J.) and 623 mg of benzyl alcohol (Fisher Scientific, Fair Lawn, N.J.) in a 20 mL scintillation vial or 500 mg of PLGA 75:25 (Resomer RG756S) and 294 mg of naltrexone free base (Tecoland Corporation, Irvine, Calif.) dissolved in 1.333 g of dichloromethane (DCM) (Fisher Scientific, Fair Lawn, N.J.) and 623 mg of benzyl alcohol (Fisher Scientific, Fair Lawn, N.J.) in a 20 mL scintillation vial. 10 mL of the continuous phase was added to the top of the organic phase and homogenized at 7,000 RPM for 60 sec with an IKA T25 homogenizer with S25N-10G generator (IKA Works, Inc. Wilmington, N.C.). The mixture was then transferred into an extraction phase, which is 380 mL of 1% (w/v) PVA in water and stirred at 4° C. for 8 h. Microparticles were then collected with a 25 μm sieve. The product retained by the sieve was dewatered for 15 min at 22° C. and vacuum dried for about 16 h. The microparticles were then suspended and washed in 200 mL of a 25% (v/v) ethanol solution for 8 h at 22° C. to remove the emulsifying agent (PVA) and any residual solvents from the microparticles. The washed microparticles were then collected on a 25 μm sieve and vacuum dried for 48 h.
Yoon, par. [0052]-[0053], Ex. 1. See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, Yoon renders claims 3 and 5 obvious.
Regarding claim 7 and the requirements:
[Claim 7] The sustained-release injectable composition according to claim 1, further containing a suspending solvent.
Yoon teaches a “naltrexone sustained release microparticle delivery systems” that is “injectable” (Yoon, abstract), and comparatively describes “Vivitrol®,” a “currently prescribed” form of “naltrexone” by an “injection [that] consists of polymer microparticles suspended in a diluent (an aqueous vehicle)” for similar, injectable administration:
[0007] Vivitrol® (Alkermes, Inc.) is currently prescribed for the prevention of relapse to opioid dependence following opioid detoxification of about 7-10 days. The recommended dose is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection consists of polymer microparticles suspended in a diluent (an aqueous vehicle) injected with a 20 gauge (G) needle. […].
[…].
[0039] In one preferred embodiment, the duration of action of naltrexone using the same dose (380 mg of naltrexone) as used in Vivitrol provides therapeutically beneficial amounts of naltrexone for greater than 4 weeks, preferably 6 weeks, more preferably 8 weeks, and even more preferably 12 weeks.
(Yoon, par. [0007] & [0039]). See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, Yoon renders claim 7 obvious.
Claim 2 is rejected under 35 U.S.C. § 103 as being unpatentable over YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”), as applied to claims 1 and 3-7, above, and further in view of ENOMURA (WO 2020/183718 A1, Publ. Sep. 17, 2020; as evidenced by US 2022/0133632 A1, Publ Publ. May 5, 2022, for English language translation; hereinafter, “Enomura”).
Paragraph numbers for Enomura refer to US 2022/0133632 A1 as an English language translation of WO 2020/183718 A1.
The teachings of Yoon, as set forth above, are hereby incorporated. However, Yoon DOES NOT EXPRESSLY TEACH the requirements of claim 2 for:
[Claim 2] The sustained-release injectable composition according to claim 1, wherein the microparticles have a value of 0.8 to 1.5 as calculated by the following Equation 2:
[Equation 2]
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wherein
D10 is the particle diameter corresponding to 10% in the cumulative size distribution of particles,
D50 is the particle diameter corresponding to 50% in the cumulative size distribution of particles, and
D90 is the particle diameter corresponding to 90% in the cumulative size distribution of particles.
which is well within the purview of the ordinarily skilled artisan.
Enomura, for instance, is directed to:
PLGA MICROPARTICLES, A SUSTAINED RELEASE FORMULATION THEREOF AND A PRODUCTION METHOD THEREOF
ABSTRACT
The present application provides approximately spherical lactic acid-glycolic acid copolymer (PLGA) microparticles comprising a biologically active substance, wherein an average volume-based particle diameter of the PLGA microparticles is 1 μm or more and 150 μm or less, and a Reactive Span Factor (R.S.F.) of the PLGA microparticles is satisfied with formula (1): 0.1<(R.S.F.)≤1.7 formula (1), wherein an R.S.F. means (D90−D10)/D50; D90 is a particle diameter (μm) corresponding to the cumulative 90% by volume of the cumulative particle diameter distribution from the small particle side; D50 is a particle diameter (μm) corresponding to the cumulative 50% by volume of the cumulative particle diameter distribution from the small particle side; and D10 is a particle diameter (μm) corresponding to the cumulative 10% by volume of the cumulative particle diameter distribution from the small particle side; and an efficient production method thereof. The present invention provides the approximately spherical PLGA microparticles having an average volume-based particle diameter of 1 μm or more and 150 μm or less wherein there are few coarse particles or ultrafine particles without a classification step, and the particle diameter distribution is sharp around the target particle diameter.
Enomura, title & abstract. In this regard, Enomura teaches that “[a] PLGA microsphere having an average volume-based particle diameter of 1 μm or more and 150 μm or less which is not a nanosphere, cannot be put in practice as its release period is designed, unless the shape and the particle diameters are adjusted”:
SUMMARY OF THE INVENTION
Technical Problem
[0019] A PLGA microsphere having an average volume-based particle diameter of 1 μm or more and 150 μm or less which is not a nanosphere, cannot be put in practice as its release period is designed, unless the shape and the particle diameters are adjusted. For example, when the particle diameters are not adjusted and wide particle diameters are included, a large amount of the biologically active substance is released from the minute particles at the initial period after administration to generate the problem of the initial burst. Since particles coarser than those having the appropriate particle diameters induce aggregation, their removal is necessary. When dispersion in the microspheres is non-uniform, there is the problem of the initial burst. In addition, since injection formulations are the most suitable for sustained-release microspheres, the production steps are required to be shortened as much as possible from the viewpoint of ensuring sterility.
[0020] In view of the above problems, an object of the present invention is to provide approximately spherical PLGA microparticles having an average volume-based particle diameter of 1 μm or more and 150 μm or less wherein there are few coarse particles or ultrafine particles without a classification step, and the particle diameter distribution is sharp around the target particle diameter; and a method capable of efficiently producing the approximately spherical PLGA microparticles.
Enomura, par. [0019]-[0029], Table 2. In this respect, Enomura evaluates particle diameter distribution of PLGA microparticles obtained from PLGA microparticle suspensions of varying solvent mixing ratios:
[0157] <Particle Diameter Distribution Evaluation>
[0158] The average volume-based particle diameter and R.S.F. of respective PLGA microparticles were measured by using respective PLGA microparticle suspensions obtained in Examples and Comparative Examples and by using Laser Diffraction Particle Size Analyser (SALD-7000, Shimadzu Corporation). The particle diameter distribution measurement results of the PLGA microparticles obtained in Example 1 are shown in Table 2.
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(Enomura, par. [0157]-[0158], Table 2), wherein the
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values (of claim 2) for:
“Example 1-1” would be 8.6/6.3 or 1.4,
“Example 1-2” would be 4.9/2.9 or 1.7, and
“Example 1-3” would be 2.8/1.9 or 1.5.
Enomura, for instance, is directed to:
PLGA MICROPARTICLES, A SUSTAINED RELEASE FORMULATION THEREOF AND A PRODUCTION METHOD THEREOF
ABSTRACT
The present application provides approximately spherical lactic acid-glycolic acid copolymer (PLGA) microparticles comprising a biologically active substance, wherein an average volume-based particle diameter of the PLGA microparticles is 1 μm or more and 150 μm or less, and a Reactive Span Factor (R.S.F.) of the PLGA microparticles is satisfied with formula (1): 0.1<(R.S.F.)≤1.7 formula (1), wherein an R.S.F. means (D90−D10)/D50; D90 is a particle diameter (μm) corresponding to the cumulative 90% by volume of the cumulative particle diameter distribution from the small particle side; D50 is a particle diameter (μm) corresponding to the cumulative 50% by volume of the cumulative particle diameter distribution from the small particle side; and D10 is a particle diameter (μm) corresponding to the cumulative 10% by volume of the cumulative particle diameter distribution from the small particle side; and an efficient production method thereof. The present invention provides the approximately spherical PLGA microparticles having an average volume-based particle diameter of 1 μm or more and 150 μm or less wherein there are few coarse particles or ultrafine particles without a classification step, and the particle diameter distribution is sharp around the target particle diameter.
Enomura, title & abstract. In this regard, Enomura teaches that “[a] PLGA microsphere having an average volume-based particle diameter of 1 μm or more and 150 μm or less which is not a nanosphere, cannot be put in practice as its release period is designed, unless the shape and the particle diameters are adjusted”:
SUMMARY OF THE INVENTION
Technical Problem
[0019] A PLGA microsphere having an average volume-based particle diameter of 1 μm or more and 150 μm or less which is not a nanosphere, cannot be put in practice as its release period is designed, unless the shape and the particle diameters are adjusted. For example, when the particle diameters are not adjusted and wide particle diameters are included, a large amount of the biologically active substance is released from the minute particles at the initial period after administration to generate the problem of the initial burst. Since particles coarser than those having the appropriate particle diameters induce aggregation, their removal is necessary. When dispersion in the microspheres is non-uniform, there is the problem of the initial burst. In addition, since injection formulations are the most suitable for sustained-release microspheres, the production steps are required to be shortened as much as possible from the viewpoint of ensuring sterility.
[0020] In view of the above problems, an object of the present invention is to provide approximately spherical PLGA microparticles having an average volume-based particle diameter of 1 μm or more and 150 μm or less wherein there are few coarse particles or ultrafine particles without a classification step, and the particle diameter distribution is sharp around the target particle diameter; and a method capable of efficiently producing the approximately spherical PLGA microparticles.
Enomura, par. [0019]-[0029], Table 2. In this respect, Enomura evaluates particle diameter distribution of PLGA microparticles obtained from PLGA microparticle suspensions of varying solvent mixing ratios:
[0157] <Particle Diameter Distribution Evaluation>
[0158] The average volume-based particle diameter and R.S.F. of respective PLGA microparticles were measured by using respective PLGA microparticle suspensions obtained in Examples and Comparative Examples and by using Laser Diffraction Particle Size Analyser (SALD-7000, Shimadzu Corporation). The particle diameter distribution measurement results of the PLGA microparticles obtained in Example 1 are shown in Table 2.
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(Enomura, par. [0157]-[0158], Table 2), wherein the
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values (of claim 2) for:
“Example 1-1” would be 8.6/6.3 or 1.4,
“Example 1-2” would be 4.9/2.9 or 1.7, and
“Example 1-3” would be 2.8/1.9 or 1.5.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to manufacture Yoon’s “controlled-release (or sustained-release) naltrexone microparticle formulations comprising naltrexone and a biodegradable polymer such as poly(lactide-co-glycolide)” (Yoon, par. [0013]) per Enomura (Enomura, abstract). One would have been motivated to do so with a reasonable expectation of success since both Yoon and Enomura are concerned with similar problems in the art, namely manufacture of PLGA microparticles. Yoon, par. [0013]; Enomura, abstract. Further, it is well within the skill of the ordinary artisan to select suitable particle size distribution parameters. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the manufacture of PLGA microparticles with D90, D50 and D10 values (Enomura, abstract) for a
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ranging from at least 1.4 to 1.5 (Enomura, par. [0157]-[0158], Table 2) in order to obtain the advantage of “few coarse particles or ultrafine particles” for a “particle diameter distribution” that is “sharp around the target particle diameter” (Enomura, abstract), thereby avoiding “the problem of the initial burst” of “non-uniform” microspheres (Enomura, par. [0019]) for sustained release (Enomura, title). In this regard, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” Further in this respect, it is further noted, “[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); and also MPEP § 2144.05(II)(A). In the instant case, D90, D50 and D10 are clearly result-effective variables, which Enomura teaches particle diameter distribution of PLGA microparticles obtained from PLGA microparticle suspensions of varying solvent mixing ratios. Enomura, par. [0157]-[0158], Table 2. Therefore, it would have been customary for an artisan of ordinary skill to select appropriate solvent mixing ratios in optimizing D90, D50 and D10 (Enomura, par. [0157]-[0158], Table 2) so that “particle diameter distribution is sharp around the target particle diameter” (Enomura, abstract).
Thus, the prior art renders claim 2 obvious.
Claim Rejections - Nonstatutory 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1 and 3-7 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-3, 5-6 and 8-9 of copending US Patent Application No. 17/762,701 (‘701 Application), in view of the disclosure of YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to microparticles composed of a biodegradable polymer and naltrexone. However, the ‘701 Application DOES NOT RECITE the requirements of claim 1 “AUCinf/Cmax” value of “120 to 320” as required by claim 1, which would be obvious per Yoon, as discussed above.
Thus, the ‘701 Application per Yoon render claims 1 and 3-7 obvious.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting over claims 1-3, 5-6 and 8-9 of copending US Patent Application No. 17/762,701 (‘701 Application), in view of the disclosure of YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”), as applied to claims 1 and 3-7, above, and further in view of the disclosure of ENOMURA (WO 2020/183718 A1, Publ. Sep. 17, 2020; as evidenced by US 2022/0133632 A1, Publ Publ. May 5, 2022, for English language translation; hereinafter, “Enomura”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
The teachings of Yoon and the ‘701 Application, as set forth above, are hereby incorporated. However, Yoon DOES NOT EXPRESSLY RECITE the requirements of claim 2 for “
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” values of 0.8 to 1.5, which would be obvious per Enomura, as discussed above.
Thus, the ‘701 Application per Yoon and Enomura renders claim 2 obvious.
Claims 1 and 3-7 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-26 of U.S. Patent 11,730,731 B2 to Kim et al., matured from copending Application No. 17/871,428 (hereinafter, ‘428 Patent), in view of the disclosure of YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to microparticles composed of a biodegradable polymer and naltrexone. However, the ‘428 Patent DOES NOT RECITE the requirements of claim 1 “AUCinf/Cmax” value of “120 to 320” as required by claim 1, which would be obvious per Yoon, as discussed above.
Thus, the ‘428 Patent per Yoon render claims 1 and 3-7 obvious.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting over claims 1-18 of claims 1-26 of U.S. Patent 11,730,731 B2 to Kim et al., matured from copending Application No. 17/871,428 (hereinafter, ‘428 Patent), in view of the disclosure of YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”), as applied to claims 1 and 3-7, above, and further in view of the disclosure of ENOMURA (WO 2020/183718 A1, Publ. Sep. 17, 2020; as evidenced by US 2022/0133632 A1, Publ Publ. May 5, 2022, for English language translation; hereinafter, “Enomura”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
The teachings of Yoon and the ‘428 Patent, as set forth above, are hereby incorporated. However, Yoon DOES NOT EXPRESSLY RECITE the requirements of claim 2 for “
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” values of 0.8 to 1.5, which would be obvious per Enomura, as discussed above.
Thus, the ‘428 Patent per Yoon and Enomura renders claim 2 obvious.
Claims 1 and 3-7 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-18 of copending US Patent Application No. 18/284,981 (‘981 Application), in view of the disclosure of YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to microparticles composed of a biodegradable polymer and naltrexone. However, the ‘981 Application DOES NOT RECITE the requirements of claim 1 “AUCinf/Cmax” value of “120 to 320” as required by claim 1, which would be obvious per Yoon, as discussed above.
Thus, the ‘981 Application per Yoon render claims 1 and 3-7 obvious.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting over claims 1-18 of copending US Patent Application No. 18/284,981 (‘981 Application), in view of the disclosure of YOON (US 2020/0113835 A1, Publ. Apr. 16, 2020; US patent family member of KR 10-2021-0065190 A on 09/23/2023 IDS; hereinafter, “Yoon”), as applied to claims 1 and 3-7, above, and further in view of the disclosure of ENOMURA (WO 2020/183718 A1, Publ. Sep. 17, 2020; as evidenced by US 2022/0133632 A1, Publ Publ. May 5, 2022, for English language translation; hereinafter, “Enomura”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
The teachings of Yoon and the ‘981 Application, as set forth above, are hereby incorporated. However, Yoon DOES NOT EXPRESSLY RECITE the requirements of claim 2 for “
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400
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” values of 0.8 to 1.5, which would be obvious per Enomura, as discussed above.
Thus, the ‘981 Application per Yoon and Enomura renders claim 2 obvious.
Conclusion
Claims 1-7 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611