DETAILED ACTION
In Reply filed 6/20/2025, claims 2, 5-9, and 15-19 are pending. Claim 8 is amended, and claim 19 is newly added. Claims 2, 5-9, and 15-19 are considered in current Office Action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim 2, 5-9, 11-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Katoh (US20120270147A1) in view of Synder (US20040140374A1), further in view of Millipore (Evidentiary Reference provided) and US 20100297548 (“Honda”).
Regarding Claim 8, Katoh discloses a particle production method (Abstract), comprising: discharging a liquid from a discharging hole (discharge hole at “droplet ejector” FIG.1 #11 [0035]) to form a liquid droplet [0077] by a liquid droplet formation unit (“drop ejection unit” FIG.1 #10 [0034]); and solidifying the liquid droplet to form a particle [0011] by a particle formation unit (“collecting unit” FIG.1 #60 [0035]);
Wherein the discharging is from a particle production apparatus (“toner production apparatus” FIG.1 #1 [0034]), comprising: a liquid droplet formation unit (“drop ejection unit” FIG.1 #10 [0034]) configured to discharge a liquid from a discharging hole (discharge hole at “droplet ejector” FIG.1 #11 [0035]) to form a liquid droplet [0077]; and a particle formation unit (“collecting unit” FIG.1 #60 [0035]) configured to solidify the liquid droplet to form a particle [0011], and a liquid housing section (“liquid container” #13 [0035]) which comprises a polymer [0086-0087];
Wherein the particle formation unit includes a conveyance gas flow (FIG.3 “carrier gas” fed by “gas feeder” [0037]), and the liquid droplet formation unit is configured to discharge the liquid [0077] so as to satisfy Formula 1 below:
F
o
r
m
u
l
a
1
:
P
=
V
j
F
d
0
ρ
V
x
2
A
cos
2
ϴ
-
65
>
1
Vj (“ejection velocity: 20m/s” [0177]) represents a velocity (m/s) of the liquid droplet (“droplets” #23; [0076]) to be discharged,
F (“voltage frequency: 340kHz” [0174]) represents a discharging drive frequency (kHz),
d0 (“diameter of droplets: 11.8 µm” [0176]) represents a diameter (µm) of the liquid droplet,
ρ represents a density (kg/m3) of the liquid (“toner” [0085]),
Vx (“velocity of carrier air: 32m/s” [0175]) represents a velocity (m/s) of the conveyance gas flow,
A represents shortest distance (m) from the liquid droplet formation unit (“droplet ejector” FIG.2 #11 of “ejection unit” FIG.1 #10 [0035]) to a center of the conveyance gas flow (center of “passage of carrier air” FIG.2 #31 [0192]), (the shortest distance corresponding to half of the cross-section of the “carrier air passage” #31 having a length of 30mm, thus A is 15mm/0.015m [0170]),
and ϴ (angle α in FIG.3 being 90°) represents an angle (deg.) at which the liquid droplet is to be discharged.
the liquid droplet formation unit ([0012] liquid column resonance chamber) is configured to vibrate the liquid to discharge the liquid droplet (vibrate the material to eject the droplet), and the discharging drive frequency (kHz) is 1 kHz or more but 150 kHz or less (Fig. 10, [0066] frequency of vibration is 130kHz).
Katoh teaches the material used for toner is not limited, such as used in carriers for medicines, also specifically including organic toner, such as polyester. Katoh does not explicitly state the liquid housing section comprises a physiologically active substance.
Synder discloses a particle production method ([0008], liquid droplet forming machine), wherein a liquid housing section ([0025], housing 50 with liquid feedstock) comprises a physiologically active substance ([0042] amino acid) and a polymer ([0042] biological polymer).
Katoh and Synder are considered to be analogous to the claimed invention because they are in the same field of liquid particle producer. It would have been obvious to one with ordinary skill in the art before the effective filing date to modify the liquid composition in Katoh to incorporate a physiologically active substance and a polymer as taught by Synder, because the composition is useful as pharmaceutical excipient with prevention of adverse toxicological effects (Synder, [0041]).
Although Katoh does not explicitly state the density of the toner liquid, Katoh discloses any known toner components can be used for the toner of the invention. In a non-limiting example, Katoh discloses the toner comprising polyester resin ([0085]). Synder teaches an analogous droplet manufacturing device [0008] forming a droplet using amino acid. The resulting droplet liquid has a density of 1420kg/m3 (See Millipore p2, amino acid Arginine has density of 1420kg/m3).
One of ordinary skill in the art would have found it obvious prior to the effective filing date of the claimed invention to select the known animo acid liquid taught by Synder, as the non-limited toner liquid of Katoh ([0085] use polyester resin which can be formed using amino acid monomer) because it has been held the selection of a known material based on suitability for its intended use support prima facie obviousness. See MPEP 2144.07. Thus, the density of the liquid toner of modified Katoh is 1420kg/m3.
Using the configuration of the liquid droplet formation unit comprising the conditions listed above for discharging the liquid, the apparatus of modified Katoh is configurated to satisfy Formula 1 given P=4.6 which is greater than 1.
Katoh further teaches the angle at which the air supplied is 40⁰ or more but 90⁰ or less and the droplet is ejected at the at the same direction as the air flow ([0008] droplet is ejected at the same direction as air, which is supplied at an angle of less than 120⁰). However, Katoh was not explicit on whether the air supply angle represents the direction of the air flow.
Honda teaches a particle production method ([0013] resin particle production method), wherein the air supply angle represents the direction of the air flow and the direction of the droplet ejection ([0013] droplet is carried by air flow in the same direction, and the air flow direction is represented by a vector with the angle).
Katoh and Honda are considered to be analogous to the claimed invention because they are in the same field of particle production method. It would have been obvious to one with ordinary skill in the art before the effective filing date to specify the air flow direction in Katoh to incorporate the equivalence of air supply angle as the air flow direction as taught by Honda, because improving the control of air supply angle to control the direction of air flow and the droplet flow helps with decreasing the probability of forming aggregates of particles ejected (Honda, [0051]).
Regarding Claim 2, modified Katoh teaches the particle production method according to claim 8, wherein Katoh discloses the value of P is 2 or more (Using the Formula 1 equation above P=4.9).
Regarding Claim 5, modified Katoh teaches the particle production method according to claim 8, wherein Katoh discloses the liquid droplet formation unit includes a piezoelectric element [0045].
Regarding Claim 6, modified Katoh teaches the particle production method according to claim 8, wherein Katoh discloses the liquid droplet formation unit is provided in a thin film including the discharging hole [0004].
Regarding Claim 7, modified Katoh teaches the particle production method according to claim 8, wherein Katoh discloses a volume average particle diameter of the particle formed is from 10 µm through 100 µm (“volume average particle diameter (Dv) of the toner preferably falls in a range from 1 µm to 20 µm” [0083]), overlapping the claimed range.
Regarding Claim 9, modified Katoh teaches the particle production method according to claim 8, wherein Katoh discloses the velocity (m/s) of the liquid droplet to be discharged is 5 m/s or more but 50 m/s or less (“ejection velocity: 20m/s” [0177, 0185]).
Regarding Claim 11, modified Katoh teaches the particle production method according to claim 8, wherein Katoh discloses the diameter (µm) of the liquid droplet is 5 µm or more but 100 µm or less (“diameter of droplets: 11.8 µm” [0176, 0178]).
Regarding Claim 12, modified Katoh teaches the particle production method according to claim 8, wherein modified Katoh further teaches the density (kg/m3) of the liquid is 500 kg/m3 or more but 1500 kg/m3 or less, as shown in the rejection of claim 1 above (“1180kg/m3”).
Regarding Claim 13, modified Katoh teaches the particle production method according to claim 8, wherein Katoh discloses the velocity (m/s) of the conveyance gas flow is 4 m/s or more but 50 m/s or less (“velocity of carrier air: 32m/s” [0175]).
Regarding Claim 18, modified Katoh teaches the particle production method according to claim 8, wherein said liquid comprises a physiologically active substance ([0042] amino acid) and a polymer ([0042] polymer).
Regarding Claim 19, Katoh discloses wherein said angle at which said liquid droplet is to be discharged is 40⁰ or more but 75⁰ or less ([0008] droplet is ejected at the same direction as air, which is supplied at an angle of less than 120⁰; Honda, [0013] droplet is carried by air flow in the same direction, and the air flow direction is represented by a vector with the angle).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Katoh (US20120270147A1) in view of Synder (US20040140374A1), Millipore (Evidentiary Reference provided), and US 20100297548 (“Honda”), as applied in claim 8 above, further in view of Onoue (WO2017150692).
Regarding Claim 14, modified Katoh teaches the particle production method according to claim 8, and teaches the method could be used to create carriers for medicines, but fails to explicitly state said physiologically active substance is selected from the group consisting of griseofulvin, itraconazole, norfloxacin, tamoxifen, ciclosporin, glibenclamide, troglitazone, nifedipine, phenacetin, phenytoin, digitoxin, nilvadipine, diazepam, chloramphenicol, indomethacin, nimodipine, dihydroergotoxine, cortisone,dexamethasone, naproxen, tulobuterol, beclometasone propionate, fluticasone propionate, pranlukast, tranilast, loratadine, tacrolimus, amprenavir, bexarotene, calcitriol, clofazimine, digoxin, doxercalciferol, dronabinol, etoposide, isotretinoin, lopinavir, ritonavir, progesterone, saquinavir, sirolimus, tretinoin, valproic acid, amphotericin, fenoldopam, melphalan, paricalcitol, propofol, voriconazole, ziprasidone, docetaxel, haloperidol, lorazepam, teniposide, testosterone, valrubicin, quercetin and allopurinol.
However, Onoue teaches a particle production method ([0008]), comprising physiologically active substance such as cortisone ([0019]).
Katoh and Onoue are considered to be analogous to the claimed invention because they are in the same field of liquid particle producer. It would have been obvious to one with ordinary skill in the art before the effective filing date to modify the liquid composition in Katoh to incorporate a physiologically active substance such as cortisone as taught by Onoue, because its soluability helps improve bioavailability when orally administered (Onoue, [0017]).
Regarding Claim 15, modified Katoh teaches the particle production apparatus according to claim 8, but fails to explicitly state said physiologically active substance is at least one substance selected from the group consisting of abacavir, acetaminophen, aciclovir, amiloride, amitriptyline, antipyrine, atropine, buspirone, caffeine, captopril, chlorquine, chlorpheniramine, cyclophosphamide, desipramine, diazepam, diltiazem, diphenhydramine, disopyramide, doxin, doxycycline, enalapril, ephedrine, ethambutol, ethinylestradiol, fluoxetine, imipramine, clomipramine, glucose, ketorol, ketoprofen, labetalol, levodopa, levofloxacin, metoprolol, metronidazole, midazolam, minocycline, misoprostol, metformin, nifedipine, phenobarbital, prednisolone, promazine, propranolol, quinidine, rosiglitazone, salicylic acid, theophylline, valproic acid, verapamil, zidovudine, and calcitonin.
However, Onoue teaches a particle production method ([0008]), comprising physiologically active substance such as abacavir.
It would have been obvious to one with ordinary skill in the art before the effective filing date to modify the liquid composition in Katoh to incorporate a physiologically active substance such as abacavir as taught by Onoue, because its soluability helps improve renders it easily dispersed in water (Onoue, [0017]).
Regarding Claim 16, modified Katoh teaches the particle production apparatus according to claim 8, but fails to explicitly state said polymer at least one polymer selected from the group consisting of a polyfatty acid ester, a poly-a-cyanoacrylic acid ester, a poly- -hydroxybutyric acid, a polyalkylene oxalate, a polyorthoester, a polyorthocarbonate, a polycarbonate which is not a polyorthocarbonate, and a polyamino acid.
However, Onoue teaches a particle production method ([0008]), comprising a polymer such as a polyamino acid ([0032]).
It would have been obvious to one with ordinary skill in the art before the effective filing date to modify the liquid composition in Katoh to incorporate polyamino acid as taught by Onoue, because it helps dispersing the physiologically active substance (Onoue, [0025]).
Regarding Claim 17, modified Katoh teaches the particle production apparatus according to claim 8, but fails to explicitly state said polymer is at least one selected from the group consisting of polylactic acid, polyglycolic acid, and polymalic acid.
However, Onoue teaches a particle production method ([0008]), comprising a polymer such as polyglycolic acid ([0032]).
It would have been obvious to one with ordinary skill in the art before the effective filing date to modify the liquid composition in Katoh to incorporate polyglycolic acid as taught by Onoue, because it helps dispersing the physiologically active substance (Onoue, [0025]).
Response to Arguments
Applicant's arguments filed 6/20/2025 have been fully considered but they are not persuasive.
Applicant argues that Katoh fails to teach a physiological active substance in a toner particle because there is no suggestion in Katoh of any advantageous effect. Applicant argues that Katoh is directed to a method of toner production and Snyder is directed to pharmaceutical application, so there is no motivation to combine Katoh and Snyder to include a physiological active substance in the toner producing method of Katoh.
The examiner respectfully disagrees. Katoh teaches a toner production method that is known to be useful for producing resins ([0003] toner production separation process for resin) used in medicine related manufacturing ([0003] resins used for carriers for medicines). Snyder teaches powder processing for pharmaceutical drug administration, which is the analogous field as the medicine carrier as described in Katoh.
Then, applicant argues that there is no motivation in Katoh to prepare toner particles at a vibrational frequency of 1 to 150 kHz. The examiner respectfully disagrees. Katoh teaches the discharging drive frequency (kHz) at 130 kHz (Fig. 10, [0066] frequency of vibration is 130kHz), which falls within the range of the limitation recited in claim 8.
Applicant’s arguments with respect to claim 19 that Katoh fails to teach a liquid discharge at an angle relative to gas flow at 40⁰ to 75⁰ have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 TIFFANY YU HUANG whose telephone number is (571)272-2643. The examiner can normally be reached 9:00AM - 5:00 PM EST.
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TIFFANY YU. HUANG
Examiner
Art Unit 1754
/SUSAN D LEONG/Supervisory Patent Examiner, Art Unit 1754
Prosecution Insights