DETAILED ACTION
Claims 1-23 are currently pending and under examination.
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 .
Priority
This application is a continuation of 18/477,752, filed 09/29/2023, a continuation of 17/308,399, filed 05/05/2021, which is a CIP of 17/213,501, filed 03/26/2021, which is a continuation of 16/872,741, filed 05/12/2020, which is continuation of PCT/JP2019/043013, filed 11/01/2019, which claims priority to JP2018-207646, filed 11/02/2018.
The JP2018-207646, PCT/JP2019/043013, 16/872,741 and 17/213,501 upon which priority is claimed fails to provide adequate support under 35 U.S.C. 112 for claims 1-23 of the instant application. The ‘646 application, the ‘013 application, the ‘741 application and the ‘501 application does not provide support for “a thickening agent added in a blending amount such that the edaravone suspension has IDDSI level in a range of 1 to 3” and “Japanese Pharmacopeia Viscosity Measurement Method II” and “range of 10 mPa.s to 1000 mPa.s in accordance with Japanese Pharmacopeia Viscosity Measurement Metod I” and the lower limit of 0.2% regarding blending among of the edaravone particles. Thus the effective filing date for claims 1-23 is deemed to be the filing date of the ‘399 application, 09/29/2023. If applicant disagrees, applicant should present a detailed analysis as to why the claimed subject matter has clear support in the earlier priority application. Applicant is reminded that such priority for the instant limitations requires written description and enablement under 35 U.S.C. 112, first paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 contains the abbreviation IDDSI without previous defining it in the claims. It would be remedial to use International Dysphagia Diet Standardization Initiative (IDDSI) in the first instant in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 and 16-17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 contains the limitation of 0.001% (w/v) to 1.0% (w/v). The instant claim has unclear metes and bounds as it is not clear if the limitations inside of the parenthesis is required or optional. Further it is unclear if the % is directed to the composition as a whole or specific ingredients in the composition.
Claim 16 contains the limitation of 0.1% (w/v) to 1.2% (w/v). The instant claim has unclear metes and bounds as it is not clear if the limitations inside of the parenthesis is required or optional. Further it is unclear if the % is directed to the composition as a whole or specific ingredients in the composition.
Claim 17 contains the limitation of 0.2% (w/v) to 36% (w/v). The instant claim has unclear metes and bounds as it is not clear if the limitations inside of the parenthesis is required or optional. Further it is unclear if the % is directed to the composition as a whole or specific ingredients in the composition.
Claim Rejections - 35 USC § 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 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.
Claim(s) 1-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0268712 in view of WO 2020/046110.
Regarding claims 1-3, 5-6, 10 and 21-23, the ‘712 publication teaches an edaravone suspension for human oral administration includes edaravone particles, a dispersant and water (abstract). The suspension is taught to be a daily administration of 90-120 mg a day administration [0101]. The particles are taught to be well dispersed in water ([0025], [0089]). A suspension is taught to contain a thickening agent [0017] wherein the thickening agents for blending amount are taught to allow a dispersed state to be maintained for a longer period of time and impart viscosity to the suspension ([0040]-[0043]). The dose is taught to be 50-210 mg [0007] with an amount of 1 to 20 ml [0007]. The administration is taught to be repeated two or more times [0096] and may be daily or intermittently [0100]. The treatment of ALS (amyotrophic lateral sclerosis) is taught [0003] and dissolution profile is taught ([0009-[0010]). “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 4, the ‘712 publication teaches administration period and a drug holiday with administration can be 14 days or 10 days to of 14 days and a holiday of 14 days ([0096]-[0098]).
Regarding claims 8-9, the ‘712 publication teaches a viscosity of the suspension in the range of 50-1750 mPa.s [0042].
Regarding claim 11, the ‘712 publication teaches wherein the dispersant is a dispersant exhibiting a transmission scattering light intensity or more [0027].
Regarding claim 12, the ‘712 publication teaches a dispersant exhibiting a contact angle of 80 degrees or less [0028].
Regarding claim 13-14, the ‘712 publication teaches a dispersant being sucrose fatty acid ester [0027] in the levels of 0.001%-1% w/v [0037].
Regarding claim 15-16, the ‘712 publication teaches xanthum gum present at 0.1-1.2 w/v ([0039]-[0041]).
Regarding claim 17, the ‘712 publication teaches blending amount of the edaravone particles is in the range of 0.06-36% w/v [0023].
Regarding claim 18, the ‘712 publication teaches the D40 partile sizxe is 50-300 um [0021].
Regarding claim 19, the ‘712 publication teaches the density is taught to be 1 g/mL-1.5 g/mL [0046].
Regarding claim 20, the ‘712 publication teaches dissolution rate of 80% or more 30 minutes after starting the test [0087].
The ’712 publication does not specifically teach the edaravone suspension has IDDSI level in a range of 1 to 3 (claim 1) specifically level 2 (claim 7).
The ‘110 publication teaches thickened compositions comprising a thickening agent (abstract) wherein the IDDSI level of 1-5 are taught as preferred, more preferably IDDSI levels 2-4 as describing the thickness of food compositions wherein IDDSI level 2 flows off a spoon, sippable (page 6) and wherein thickening to the desired viscosity (page 7).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the IDDSI range claimed as the ‘712 publication teaches the formulation to be an oral formation with a range of thickening and the ‘110 publication teaches the desired range of IDDSI in oral thickeness solution and a method of optimizing such IDDSI through the amount of thickening agents used, thus it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the IDDSI and thickness/viscosity of the solution. As MPEP 2144.05 recites “where 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 optimization”.
Claim(s) 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0328711 to Moolenaar et al., in view of JP 2004091441 A (cited on IDS).
Moolenaar teaches water dispersible composition of edaravone, for dispersing in to aqueous liquid (abstract), wherein the composition comprises 2-50% of edaravone and 3-50% alkalizing agent, so as to be easily dispersed in aqueous liquid (abstract, 0030). While Moolenaar does not explicitly teach a composition comprising edaravone particles, water and a dispersant (claim 1), claim 3 of the reference teaches that the composition can include any of the excipients selected from the group consisting of a disintegrant, binder, effervescent, filler, disintegrant or a combination thereof.
With respect to the instant claimed limitation that the dispersant maintains edaravone in suspension, while Moolenar teaches eventually solubilizing water dispersible edaravone granules, Moolenaar also teaches solid edaravone that is stable and packaged in sachets [0039], which implies that the solid particles are not necessarily solubilized. Further, examples 3 and 4 are directed to a suspension and not solution form. Moolenaar teaches incorporation of various excipients in the composition and teaches hypromellose, methylcellulose, as well as gums such as tragacanth gum for wicking and swelling properties [0049] and teaches hypromellose, methylcellulose, as well as gums such as tragacanth gum, and polyvinyl alcohol [0049] as binders, for causing the adhesion of edaravone particles within the granules [0051]. Moolenaar further teaches surfactants such as polysorbate [0063]. Even though Moolenaar does not explicitly mention dispersants and instant claims do not recite any specific dispersant, instant specification describes hypromellose, methylcellulose and polysorbate as dispersants, and hence the property of dispersing is implicit.
In this regard, Example 1 JP 2004091441 teaches oral liquid compositions prepared by combining edaravone and 1 vol% tragacanth solution, to be grounded to and dispersed (page 18). While the reference does not clearly state a final suspension, it is implicit from the example that the liquid is a dispersion.
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare dispersed oral liquid composition of edaravone and further incorporate methylcellulose, hypromellose, polyvinyl alcohol, polysorbate etc., in preparing the oral composition of edaravone and further expect to disperse the edaravone particles, and an excipient such as a disintegrant or binder etc., in water so as to prepare a highly bioavailable edaravone composition. The motivation to do so comes from the teachings of JP reference that teaches adding 1 vol% of tragacanth to edaravone can be prepared as dispersion for oral administration (in a liquid form) and that Moolenar teaches edaravone particles can be dispersed including any of the above binders, fillers provide improved the bioavailability. For the amounts of dispersing agent (claim 4 of the reference teaches 0.001% w/v to 1.0% w/v), paragraph [0063] of Moolenar teaches 0.5% to 15% which overlaps with the claimed amounts. 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). Accordingly, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose as low as 0.5% to 1.0% of surfactant such as polysorbate with an expectation to arrive at the claimed amounts in preparing edaravone suspension composition. Further, one skilled in the art would have been motivated to further include gums such as tragacanth gum, in an appropriate amount, for providing the desired binding and/or thickening effect with tragacanth gum, and thus arrive at the instant claimed composition. Therefore, even though Moolenar describes the instant gums as binders or disintegrants, the ability to act as thickeners is a property of the said gums. One of an ordinary skill in the art would have been able to employ a suitable amount of a thickening gum from the excipients of Moolenaar depending on the need to thicken the oral composition. In this regard, table 4 of Moolenaar teaches compositions that are both clear and also cloudy.
For claim 18, Moolenaar teaches powder particles having a particle size range of 40-950 microns and the granules having a size range of 100-1000 microns [0056-0057]. In particular, Moolenaar teaches edaravone microparticles having a 90% distribution in the size range of 0.2 to 50 microns [0066], more particularly, a volume distribution of Dv(10):1.6µ, Dv(50):12.6µ and Dv(90):72.6µ (example 1), [0112-0115]. Thus, the particle size range taught by Moolenaar overlaps with instant claimed ranges. 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). Accordingly, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to optimize the size of the of edaravone particles and size distribution, in the composition of Moolenaar, so as to arrive at the claimed ranges because Moolenaar teaches that the powder formulation in the above size ranges [0054-0057] for effective granulation and one skilled in the art would have expected to provide the desired bioavailability of edaravone.
For the claimed dissolution, Moolenaar teaches that the oral composition reaches Tmax in 5 mins and shows high bioavailability [0137]. Further, Moolenaar teaches edaravone composition as an ALS therapeutic agent and exemplifies an oral dose of 50 ml or 750 mg in 50 ml. While instant claim 1 recites 1-20 mL and edaravone in a range of 50 to 210 mg, Moolenaar teaches that edaravone can be administered in an amount range of 30-300 mg that includes the claimed amount 50-210 mg. Moolenaar teaches higher volumes containing higher amounts of edaravone. Thus, one skilled in the art would have been able to proportionately reduce the amount of edaravone and administer a minimum volume of drug suspension, depending on the density of the suspension and provide appropriate dissolution with an expectation to achieve the desired bioavailability of the drug. The determination of the best individual treatment schedule, in particular the prescribing and modification of drug dosage regimens used for administering a particular medicament, so as to comply with the specific needs of a patient, such as a child, and to achieve the desired results of the treatment in an individual patient, is part of the routine practice of a medical practitioners in his provisions skill in alleviating the symptoms of suffering and illness.
With respect claims 20-23, Moolenar do not teach the claimed dissolution rates, confidence interval of a ratio of Cmax and AUC or the claimed ratio of Cmax and AUC of the oral versus injection formulation. However, Moolenar desires an orally administrable composition that has high bioavailability on oral administration as opposed to injection formulation. Accordingly, it would have been obvious for one skilled in the art before the effective filing date of the instant invention was made to prepare the formulation of Moolenar with an appropriate amount of edaravone and suitable amounts of dispersants such as disintegrants, so as to achieve a desired pharmacokinetic profile upon oral administration as opposed to conventional approaches such as injection.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10987341; and claims 1-20 of U.S. Patent No. 11241416; claims 1-20 of US patent 11957660; claims 1-20 of US 11478450; claims 1-24 of US 11826352; claims 1-20 of US 12,285,409; claims 1-20 of US 12599586 and claims 1-20 of US 11,241,416 in view of US 2019/0328711.
Instant claims are directed to a method for treating amyotrophic lateral sclerosis comprising orally administering, to a patient in need thereof, an edaravone suspension for human oral administration, comprising: water; edaravone particles comprising edaravone and dispersed in the water; and a dispersant dispersing the edaravone particles in the water such that the dispersant maintains the edaravone particles in a solid particle state in the water, a thickening agent added in a blending amount such that the edaravone suspension has IDDSI level in a range of 1-3, the dosage range of 50-210 mg/dose in 1-20ml one to three times a day, wherein a blending amount of the edaravone particles is in a range of 0.2% (w/v) to 36% (w/v), and when edaravone in the edaravone suspension is in a range of 90 to 120 mg, edaravone in a plasma exhibits a mean Cmax in a range of 500 to 2500 ng/mL and a mean AUC.sub.0-∞ in a range of 1000 to 2500 h*ng/mL when the edaravone suspension is orally administered to a human.
Patent claims of US 10987341 are directed to an edaravone suspension for human oral administration, comprising: water; edaravone particles comprising edaravone dispersed in the water; and a dispersant dispersing the edaravone particles in water such that the dispersant maintains the edaravone particles in a solid particle state in the water, wherein a blending amount of the edaravone particles is in a range of 0.5% (w/v) to 36% (w/v), and the dispersant is at least one dispersant selected from the group consisting of polyvinyl alcohol, methylcellulose, hypromellose, sucrose fatty acid ester and polysorbate. Thus, the patented claims recite an amount of dispersant that is within the claimed ranges, with sufficient specificity and therefore anticipates instant claimed range. Patented claims further teach the instant claimed thickening agents, dispersants, oral composition for treating ALS, including the claimed pharmacokinetic features and a range of viscosity demonstrating an optimizable parememter and reading on the IDDSI level instantly claimed.
Patent claims of 11241416 are directed to an edaravone suspension for human oral administration, comprising: water; edaravone particles comprising edaravone and dispersed in the water; and a dispersant exhibiting a transmission scattering light intensity of 1% or more and dispersing the edaravone particles in the water such that the dispersant maintains the edaravone particles in a solid particle state in the water, wherein a blending amount of the dispersant is in a range of 0.001% (w/v) to 1.0% (w/v), a blending amount of the edaravone particles is in a range of 0.5% (w/v) to 36% (w/v), and when edaravone in the edaravone suspension is in a range of 90 to 120 mg, edaravone in a plasma exhibits a mean Cmax in a range of 500 to 2500 ng/mL and a mean AUC.sub.0-∞ in a range of 1000 to 2500 h*ng/mL when the edaravone suspension is orally administered to a human. Thus, the patented claims recite an amount of dispersant that is within the claimed ranges, with sufficient specificity and therefore anticipates instant claimed range. Patented claims further teach the instant claimed thickening agents, dispersants, oral composition for treating ALS, including the claimed pharmacokinetic features and a range of viscosity demonstrating an optimizable parameter and reading on the IDDSI level instantly claimed.
Patented claims of US patent 11957660 are directed to an edaravone suspension for human oral administration, comprising: water; a thickening agent comprising at least one of tragacanth powder and xanthan gum; edaravone particles comprising edaravone and dispersed in the water; and a dispersant dispersing the edaravone particles in the water such that the dispersant maintains the edaravone particles in a solid particle state in the water, wherein a blending amount of the edaravone particles is in a range of 0.2% (w/v) to 36% (w/v), and the edaravone suspension does not contain a preservative selected from the group consisting of methylparaben, ethylparaben, propylparaben, butylparaben, benzoic acid, sorbic acid, sodium benzoate, benzyl alcohol, phenylethanol and a combination thereof in range of concentrations, and does not have a bacterial growth for at least 28 days according to the preservation efficacy test of Japanese Pharmacopeia. Thus, the patented claims recite the same amount of dispersant as the instant claimed ranges. Patented claims further teach the instant claimed thickening agents, dispersants, oral composition for treating ALS, including the claimed pharmacokinetic features. Instant claims do not recite the absence of the preservatives excluded by the patent claims, and hence read on the above claims and a range of viscosity demonstrating an optimizable parameter and reading on the IDDSI level instantly claimed.
Patented claims 1-20 of US 11478450 are directed to a method of treating amyotrophic lateral sclerosis, comprising: orally administering, to a patient in need thereof, an oral formulation comprising edaravone such that an amount of the edaravone in oral administration is in a range of 60 to 400 mg/day, wherein the oral formulation is an edaravone suspension comprising water, the edaravone comprising edaravone particles dispersed in the water, and a dispersant dispersing the edaravone particles in the water such that the dispersant maintains the edaravone particles in a solid particle state in the water, the oral administration comprises administering the oral formulation to the patient in need thereof such that the oral administration of the edaravone is in a range of 50 to 210 mg/dose and that a dose of the oral formulation is in an amount in a range of 1 to 20 mL, the oral administration comprises a number of administrations in a range of once to 3 times per day and includes administering the oral formulation to the patient in need thereof daily or intermittently, and the oral formulation is formulated such that when the oral formulation comprising the edaravone in a range of 90 to 120 mg is orally administered to the patient, edaravone in the plasma of the patient exhibits a mean Cmax in a range of 500 to 2500 ng/mL and a mean AUC.sub.0-∞ in a range of 1000 to 2500 h*ng/mL Further, the dependent claims of the above patent recite the instant amounts of edaravone particles, particle sizes of edaravone, and the dispersants and a range of viscosity demonstrating an optimizable parameter and reading on the IDDSI level instantly claimed.
Patented claims 1-24 of US 11826352 are directed to an edaravone suspension for human oral administration of an amyotrophic lateral sclerosis therapeutic agent, comprising: water; edaravone particles comprising edaravone and dispersed in the water; a dispersant dispersing the edaravone particles in the water such that the dispersant maintains the edaravone particles in a solid particle state in the water; and a thickening agent added in a blending amount such that the edaravone suspension has IDDSI level in a range of 1 to 3, wherein the thickening agent is at least one thickening agent selected from the group consisting of xanthan gum and tragacanth powder, and a blending amount of the edaravone particles is in a range of 0.2% (w/v) to 36% (w/v). Further, the dependent claims of the above patent recite the instant amounts of edaravone particles, particle sizes of edaravone, and the dispersants.
Patented claims 1-20 of US 12285409 are directed to an edaravone suspension for human oral administration of an amyotrophic lateral sclerosis therapeutic agent, comprising: water; edaravone particles comprising edaravone and dispersed in the water; a dispersant dispersing the edaravone particles in the water such that the dispersant maintains the edaravone particles in a solid particle state in the water; and a thickening agent added in a blending amount such that the edaravone suspension, wherein the thickening agent is at least one thickening agent selected from the group consisting of xanthan gum and tragacanth powder, and a blending amount of the edaravone particles is in a range of 0.2% (w/v) to 36% (w/v). Further, the dependent claims of the above patent recite the instant amounts of edaravone particles, particle sizes of edaravone, and the dispersants, treatment of ALS and a range of viscosity demonstrating an optimizable parameter and reading on the IDDSI level instantly claimed.
Patented claims 1-20 of US 12599586 are directed to an edaravone suspension for human oral administration of an amyotrophic lateral sclerosis therapeutic agent, comprising: water; edaravone particles comprising edaravone and dispersed in the water; a dispersant dispersing the edaravone particles in the water such that the dispersant maintains the edaravone particles in a solid particle state in the water; and a thickening agent added in a blending amount such that the edaravone suspension, wherein the thickening agent is at least one thickening agent selected from the group consisting of xanthan gum and tragacanth powder, and a blending amount of the edaravone particles is in a range of 0.2% (w/v) to 36% (w/v). Further, the dependent claims of the above patent recite the instant amounts of edaravone particles, particle sizes of edaravone, and the dispersants, treatment of ALS and a range of viscosity demonstrating an optimizable parameter and reading on the IDDSI level instantly claimed.
Each of the patents do not specifically teach a method of treating Amyotrophic lateral sclerosis, however the ‘711 publication teaches a composition of edaravone being ingested by a patient (abstract) to treat ALS ([0004], [0094]). Thus it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the edaravone containing oral compositions taught by the disclosed patents in the treatment of ALS.
Thus, each of the above patents are not different from the instant claimed oral edaravone suspension composition, including the dispersants, thickening agents, particle sizes and the amounts of dispersants that fall within the claimed range. Accordingly, although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
