DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 2/10/2026 As directed by the amendment: claims 1-7 have been withdrawn as pertaining to an invention not elected by applicant, and claims 8-14 have been added. Thus, claims 8-14 are presently pending in this application.
Response to Arguments
Applicant’s arguments filed 2/10/2026 with respect to the independent claim(s), particularly the claimed subject matter of “a notification unit that makes a predetermined notification to a user, [after] a rupture portion of the target region is closed, for canceling a contact state between the ejection portion and the surface of the target region” 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. Instead, the present rejection of record relies upon the prior art of US 20090227942 A1 for the teachings of such a point in an ejection process when a rupture portion may be closed, indicating that an ejection is completed and an invention may be removed from a user.
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable. See examiner's rejection as necessitated by the amendment for the prior art relied upon which discloses/teaches the claim limitations.
Claim Rejections - 35 USC § 103
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20020188419 A1, henceforth written as Slate, in view of US 20090227942 A1, henceforth written as Stroem.
Regarding Claim 8,
Slate discloses:
A needleless injector
(injector 30; fig 2)
that ejects an intended injection substance from an ejection port into a target region in a state in which the ejection port is in contact with a surface of the target region, the needleless injector comprising:
(paragraph 29+32; fluid medicament disposed in chamber 52 is ejected from an opening (not enumerated) of distal end 34 and into a subcutaneous pocket of the patient when the injector is held against the patient's skin; fig 3)
a housing part
(tubular housing 32; fig 3)
that has an accommodating space that accommodates the intended injection substance;
(medicament chamber 52; fig 3)
a nozzle portion that defines a flow path for guiding the intended injection substance accommodated in the housing part to the ejection port;
(injector tip 54; fig 3)
a driving part that imparts ejection energy for ejecting the intended injection substance;
(spring 56; fig 3)
a pressurizing portion that pressurizes the intended injection substance accommodated in the accommodating space
(plunger 50; fig 3)
via a propellant disposed to move or deform in a predetermined direction inside the needleless injector by imparting the ejection energy;
(drive bar 46; fig 3)
and a notification unit
(system 10; fig 1)
a notification unit that makes a predetermined notification to a user, at least at a predetermined time after the intended injection substance is delivered into the target region -- for canceling a contact state between the ejection port and the surface of the target region.
(paragraph 26-27+29+35-42; switches 14, 24, 70, 76, 78 change between an OFF/ON state in different phases of the inventions operation and this operational information is recorded by memory 18, therein the data communicated by this change in state constitutes making a notification of predetermined information; see paragraph 29+44 particularly note that an end of stroke switch 76 is triggered when the injection of medicament into a subcutaneous pocket of a patient is completed, therein a time required to deliver a medicament into a target region, and consequently a vacuum switch 70 is triggered, powering off vacuum pump 28 and therein allowing a contact state between the opening (not enumerated) of distal end 34 and a patient to cancelled)
Slate discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a predetermined notification to a user, -- after --- a rupture portion of the target region is closed, for canceling a contact state between the ejection port and the surface of the target region.
However Stroem teaches a jet injector invention:
Wherein the jet injector stretches the skin of a patient via applying suction means, see paragraph 37-40 of Stroem, which creates a subcutaneous injection channel, see paragraph 12-13 and fig 3-5, for receiving the injected medicament and upon termination of the suction means the injection channel is closed such that the ejected medicament may be better retained in/under the skin.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Stroem’s teachings of utilizing a skin suction mechanism during jet ejection to open/close a fluid retaining injection channel to the skin suction mechanism disclosed by Slate, such that the subcutaneous pocket for receiving medicament created by Slate’s vacuum pump 28 is closed upon terminating the suction in the vacuum pump 28, in order to advantageously arrive at an invention which can seal a space which receives medicament and consequently improve the likelihood that all administered medicament is retained by a patient subcutaneously and does not leak out and reduce the effective administered dose.
Examiner notes that in light of the modification of Slate in view of Stroem, above, the modified invention makes the predetermined notification that a contact state may be cancelled when Slate’s memory 18 records that Slate’s vacuum switch 70 is moved into an open position, which corresponds with powering off the vacuum and thus closing of the injection channel/subcutaneous pocket/rupture portion, such that such a notification is not made until the injection substance has been ejected and the rupture portion has been closed.
Regarding Claim 9, the modified invention of Slate in view of Stroem discloses:
The needleless injector according to claim 8, wherein the notification unit continuously generates a signal related to the predetermined notification during a time from the start of the imparting of the ejection energy by the driving part to an end of the time required to close the rupture portion of the target region after ejection of the intended injection substance.
Slate: (paragraph 26-27; real time clock 16, of system 10, actively tracks the time between triggering of switches, therein a signal relating to the predetermined notification, and does so while ejection energy is imparted by the claimed driving part)
Regarding Claim 10, the modified invention of Slate in view of Stroem discloses:
The needleless injector according to claim 8, further comprising: a storage unit
Slate: (paragraph 27; nonvolatile memory 18; fig 1)
that stores first information pertaining to the target region and the user,
Slate: (paragraph 27; memory 18 stores patient's compliance with a prescribed medicament dosing regimen applied to a patient's skin)
wherein the notification unit makes the predetermined notification based on the first information stored in the storage unit.
Slate: (paragraph 27; recorded/stored injection duration is used to determine whether an injection event corresponds to a valid patient injection or an invalid firing)
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Slate in view of Stroem as applied to claim 8 above, and in view of US 20160106925 A1, henceforth written as Boesen.
Regarding Claim 11,
Slate in view of Stroem discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, it is silent regarding:
a predetermined sensor that acquires second information pertaining to the target region near the ejection port in the contact state between the ejection port and the surface of the target region wherein the notification unit makes the predetermined notification based on the second information acquired by the predetermined sensor.
However, Boesen further teaches an injection device comprising:
a predetermined sensor
(Boesen: fig 4; skin temperature sensor(s) 166; paragraph 36)
that acquires second information pertaining to the target region near the ejection port in the contact state between the ejection port and the surface of the target region,
(Boesen: fig 4; skin temperature sensor(s) 166 detect the temperature of the skin at the injection site; paragraph 36)
wherein the notification unit makes the predetermined notification based on the second information acquired by the predetermined sensor.
(Boesen: paragraph 37, intelligent control 170 can make determinations from the sensors, dosage information, and internal clock to determine the time of distribution)
Examiner notes that, Boesen additionally provides in paragraph 29, that certain parameters such as “time of administration, dose administered, skin temperature or ambient temperature at the time of administration, failure of dosing or of the needle advance/retract system, location of the administration on the body, geographic location of the administration, among other parameters”, emphasis added, are pertinent to the effective and timely administration of medication.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the skin temperature sensor taught by Boesen to the needleless injector with notification unit directed by Slate in view of Stroem in order to ascertain and consequently analyze pertinent parameters, such as skin temperature, for executing an effective administration of medication, paragraph 29 of Boesen.
Regarding Claim 12
Slate in view of Stroem discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, it is silent regarding:
further comprising: a pressure sensor that detects the contact state between the ejection port and the surface of the target region, wherein the notification unit makes an additional notification to a user so that a pressing force of the ejection port against the surface of the target region is increased when a detected value from the pressure sensor falls below a predetermined first pressure value until a time required to close the rupture portion of the target region after ejection of the intended injection substance has elapsed from the start of imparting of the ejection energy by the driving part.
However, Boesen teaches an injection device comprising:
comprising a pressure sensor
(Boesen: paragraph 35-36; pressure/contact sensor(s) 144 148; fig 3)
that detects the contact state between the ejection port and the surface of the target region,
(Boesen: paragraph 35; pressure sensors determine if sufficient pressure is being applied to properly dispense medication)
wherein the notification unit makes an additional notification to a user
(Boesen: paragraph 35-36, intelligent control issues a warning/alert to the user that a pressure/contact is sufficient or insufficient; examiner notes that this notification is inclusive of the communication of prohibiting injection activation before adequate pressure is applied)
so that a pressing force of the ejection port against the surface of the target region is increased when a detected value from the pressure sensor falls below a predetermined first pressure value until the ejection period has terminated.
(Boesen: paragraph 35+37; intelligent control provides feedback over time to include warning the user to "apply additional pressure" during the use of the device, e.g. while ejection is occurring)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Boesen’s teachings of a notification unit leveraging data from a pressure sensor to direct a user to improve the contact between the invention and themselves into the notification unit and injector disclosed by Slate in view of Stroem in order to convey information which is critical for the user to adequately steer and execute an injection, see paragraph 35-36 of Boesen, and therein improve delivery of life-saving media and curtail risks associated with a poor injection such as worsening illness and death.
Examiner notes that in light of the modification of Slate in view of Stroem above, Slate’s invention permits contact between the invention and the user to be cancelled once the vacuum switch 70 has been triggered, when the claimed rupture portion is closed, thus when incorporating Boesen’s teachings, above, of conveying information pertaining to a user applying a sufficient/insufficient amount of force to maintain contact is continued over this ejection period until the modified invention is intended to be removed from contact with the user’s skin.
Regarding Claim 13, the modified device of Slate in view of Stroem and Boesen teaches:
The needleless injector according to claim 12, wherein the driving part is allowed to operate when the detected value from the pressure sensor is a predetermined second pressure value or greater
(Boesen: paragraph 35, if sufficient contact pressure is not met then the injection procedure may not be initiated via electronic activation)
Examiner notes that as Slate in view of Stroem was modified with Boesen’s contact guiding teachings, incorporated in claim 12 above, the claimed driving part of Slate is allowed to operate, therein initiate injection, when a certain minimum contact pressure is met.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Slate in view of Stroem as applied to claim 8 above, and further in view of US 20020058907 A1, henceforth written as Deboer.
Regarding Claim 14,
Slate in view of Stroem discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, it is silent regarding:
further comprising: a space defined inside the needleless injection and configured to retreat the nozzle portion to the inside of the space
to cancel the contact state between the ejection port and the surface of the target region when the notification unit makes the predetermined notification.
However, Deboer teaches a needleless injector comprising:
further comprising: a space defined inside the needless injection and configured to retreat the nozzle portion to the inside of the space
(Deboer: fig 2-3; retracting mechanism (not enumerated) includes a space (not enumerated) for retaining the probe 50 in a neutral, or retreat, position; paragraph 44-45)
to cancel the contact state between the ejection port and the surface of the target region when the notification unit makes the predetermined notification.
(Deboer: the contact state between Deboer's nozzle and the surface of Deboer's target region is cancelled when the medication has been completely expelled, therein aligning with the time when notification unit of the previous combination makes the predetermined notification)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the retracting nozzle mechanism taught by to the needleless injector disclosed by Slate in view of Stroem in order to improve procedure’s efficacy by reducing the pressure needed to break the skin barrier and administer the medicament, Deboer paragraph 52.
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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