DETAILED ACTION
Response to Amendment
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/21/2026 has been entered.
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 5, 8, 10, 11, 31, 32, 37, 38, 39-40, and 45-47 are 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.
In regard to claim 1, it is unclear if the recited first and second delivery profile recited are the same delivery profiles of now recited “a delivery profile from a plurality of stored delivery profiles” in claim 1. For the purposes of this action, the examiner is assuming that they are the same and suggests making the appropriate corrections to the antecedent basis.
The same issues exist in claims 6 and 10.
The dependent claims are rejected by virtue of dependency on the rejected claim 1.
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.
Claim(s) 1-2, 5, 8, 10, 11, 31, 32, 37, 38, 39-40, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2010/0016827; hereafter Hunter) in view of D’Antonio et al. (US 6,056,716; hereafter D’Antonio) and in further view of Hunter et al. (US 2006/0258986; hereafter Hunter 2) and in further view of Spicola, Jr. (US 2013/0321600; hereafter Spicola) and in further view of Toles et al. (US 2010/0004621; hereafter Toles) and further in view of Goll (US 20020055729) and/or Srinivasan et al. (US 2006/0184101; hereafter Srinivasan ‘101).
In regard to claim 1, Hunter discloses a needle-free injector (see at least Figure 9 for an illustration of one anticipatory embodiment), comprising: a housing (900); at least one chamber (990) within the housing constructed and arranged to be fluidly coupled to at least one source (950) of an injectate; at least one nozzle (910) fluidly coupled to the chamber (990); a plunger (920) slidably coupled to and disposed within the chamber (990), the plunger positioned to discharge a bolus of the at least one injectate through an exit port (exit port of 910) when slid within the chamber; a motor (242) operatively coupled to the plunger, the motor operable to actuate the plunger in the chamber; and a controller (965) operatively coupled to the motor, the controller operable to operate the plunger according to a first delivery profile, the first delivery profile configured to inject a first bolus of a first injectate to a first predetermined depth in a subject, the controller further operable to operate the plunger according to a second delivery profile configured to inject a second bolus of a second injectate to a second predetermined depth in the subject (see par. [0063]-[0072] and [0096]-[0104]), wherein the first predetermined depth and the second predetermined depth are such that the first bolus and the second bolus do not mix at the injection site upon injection into the subject (italicized language is interpreted as functional; Hunter discloses different stored delivery profiles which result in different depths of injection; the mere delivery at different depths results in no mixing but the examiner also notes that the unit is movable to a different position so even two injections at the same depth but at different locations would result in no mixing).
In regard to claim 1, Hunter fails to disclose further comprising a marking system configured to apply an identifier on the subject and wherein the controller is configured to apply the identifier with the marking system in response to delivery of the first bolus and the second bolus to the subject and fails to disclose a sensor configured to acquire a signal from a detectable marker on a specific animal, wherein the controller is configured to read the detectable marker on the specific animal, and to associate an injection of the first bolus and the second bolus with the specific animal.
In a similar art, D’Antonio discloses an automatic marking system to be used with respect to large numbers of animals or humans in close proximity to each other. The system includes a nozzle adjacent to the injection nozzle. The marking system automatically marks the subject when an injection is given. The marker, which should be a non-toxic dye, is preferably such that its expected life does not exceed the time between injections. Different indicia, such as using more than one color of the dye, will make multiple injections distinguishable. In this way, the user is able to tell which of the animals and/or humans in a large, close proximity group have already been injected with a particular product so that none are missed and none are injected more than once. (see col. 7, lines 3-16). Specifically, in the embodiment shown in Figures 7C and 7CC, the injector system includes an additional container (963) with a dye material (the indicator) that is transported to exit nozzle (967) through connecting tube (964). The dye is drawn into the dye chamber at the same time that the serum is drawn into the serum chamber for injection and the dye is injected and deposited at the site of serum injection as an indicator for injection. See col. 24, line 54- col. 25, line 14.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hunter with the marking system of D’Antonio in order to provide a means for keeping track of injections in large scale human or animal injections. The incorporation of the teaching of D’Antonio into the system of Hunter would include a system including an injector to inject the animals and a marking system to mark inoculated animals when the injection is made, wherein the injection and therefore the marking system are controlled by the controller. The marking system and injector are configured to deliver multiple doses.
Hunter and D’Antonio, in combination, fail to teach further comprising a sensor configured to acquire a signal from a detectable marker, wherein the controller is configured to read the detectable marker on the specific animal.
In a similar art, Hunter 2 teaches a sensor 1310 may also be provided to identify an animal prior to administering a transdermal transfer. For example, the animal 1302 can include an identifying mark 1312, such as a bar-code tag or a radio frequency identification (RFID) tag (the claimed detectable marker). The sensor 1310 can therefore include an interrogator adapted to read a bar-code or RFID tag. The sensor 1310 and the transdermal transport device 1306 are both coupled to a controller 1314, which may include a processor. A power source 1316 is also coupled to the transdermal transfer device 1306 through the controller 1314.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the sensor as disclosed by Hunter 2 in order to provide the system with a means for identifying the animal to be injected thereby avoiding any improper injections.
The combination still fails to teach wherein the controller is configured to associate an injection of the first bolus and the second bolus with the specific animal, the controller further configured to identify a species of the subject from information obtained from the detectable marker and to automatically adjust dosing for the subject by adjusting an injectate velocity of the injection according to the first predetermined depth of delivery, the second predetermined depth of delivery, the species of the subject, and a delivery location on the subject. Hunter 2 discloses the structure for identifying the animal before the injection but fails to expressly disclose recording or associating the instant injection of the first and second bolus as is now recited in claim 1.
In a similar art, Spicola discloses (see at least par. [0079]) an animal identification system 340 that is configured to identify one or more animals within the chute system 300 based on any number of different factors or criteria with respect to the animal identification system 140. In some embodiments, the animal detection system 340 includes at least an information reading device, such as a wireless reading device (e.g., an RIFD reading device) that is configured to communicate with (e.g., read) information tags (e.g., RFID tags) affixed in or on different animals. For example, animals can have an RFID tag attached to one or more parts of their bodies (e.g., their ears). The animal identification system 340 is in communication with the control system 400 so that the control system 400 can know when a particular animal is in the chute system 300 (e.g., as a result of the detection system 340 reading an RFID tag associated with the animal) and can associate the determined characteristics with the particular animal. In some cases, the control system 400 can, either on its own or in connection with an external computing system, track characteristics of animals, as well as track various markings applied to the animal or injections administered to the animals using the chute system 300 or other devices [emphasis added by examiner]. The system of Spicola not only identifies the animal before injection (as is performed by Hunter 2) but also goes the step further of tracking the injections done by the chute system as is disclosed/recited by the applicant. Spicola further teaches controlling drug delivery based on the animal detection system. See par. [0086].
“When an animal enters the chute system and an animal identification system (e.g., the identification system 140 or the identification system 340) identifies the animal (e.g., by reading an RFID tag), the control system may then control an animal injection system (e.g., the injection system 180, for example, using the connection mechanism (e.g., the robotic arm) 184.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the teachings of Spicola in order to provide a system which can not only identify an animal but also track the injection history to avoid a missed injection or prevent a redundant injection and to also automatically adjust dosing based on the reading of the tag to administer the proper dose to the correct animal.
The combination still fails to expressly disclose or teach further wherein the controller is configured to automatically adjust dosing by adjusting an injectate velocity of the injection according to the first predetermined depth of delivery, the second predetermined depth of delivery, the species of the subject, and a delivery location on the subject as is now recited in claim 1.
In a similar art, Toles discloses a system for needle-free injection wherein the injection pressure of the injection takes into consideration the type of species and the region of injection of that species and also the age of the species to ensure that the proper depth is reached for injection. See par. [0126].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the teaching of Toles in order to provide a system for injecting subjects at the optimal depth for that particular species.
The combination does not expressly disclose that the predetermined depth of delivery of the injectate based on species is incorporated into information held by the detectable marker as is now recited.
However, this feature would only involve routine skill in the art. Spicola already teaches a system in which an information reading device (for example, an RFID reading device) is configured to read an RFID tag on the animal, wherein the RFID tag includes identifying information about the animal (see par. [0079]). Toles, as described directly above, teaches that is already known to tailor the injection pressure and velocity to the species of animal/region of animal being injected. Incorporating the information of Toles into the system of Spicola so that the RFID tag includes identifying information about the species of animal thereby enabling the animal identification system to automatically choose the proper injection profile is well within the skill of the ordinary artisan and is suggested by the art.
The combination thus far teaches a system that can read a detectable marker on the animal and control deliver depth based on the species and location and teaches using different injectate pressure. However, the combination does not necessarily teach adjusting the injectate velocity as is recited. The ordinary skilled artisan would appreciate that the injectate velocity and pressure are linked in a predictable manner.
In a similar art, Goll teaches that the penetration depth of the fluid exiting the injection port 30 into the heart tissue influences tissue trauma, fluid retention in the tissue, and the volume of tissue treated with the fluid. The penetration depth of the fluid is dictated, in part, by the exit velocity of the fluid from the injection port 30, nature of the fluid, the size of the fluid stream exiting the injection port 30, and the properties of the heart tissue (i.e., the myocardium, epicardium, endocardium). The exit velocity, in turn, depends on the applied pressure of the pressurized fluid source 20, the drag or pressure drop along the length of the infusion lumen 38 and nozzle lumen 40, and the cross-sectional area or size of the injection port 30. The size of the fluid stream exiting the injection port 30 also depends on the size and geometry of the nozzle 26, and in particular, the size and geometry of the nozzle lumen 40 and injection port 30. Thus, assuming the treatment site dictates the tissue properties, and the particular therapy dictates the fluid and thus the fluid properties, the penetration depth may be selected by adjusting the applied pressure of the pressurized fluid source 20, the size and length of the infusion lumen 38, and the size and geometry of the nozzle 26 (i.e., the nozzle lumen 40 and injection port 30). By adjusting these parameters, fluid retension, treated tissue volume and degree of tissue trauma may be modified as required for the particular clinical application.
The ordinary skilled artisan would recognize that controlling the injection pressure will predictably control the injection velocity to control the injection depth as taught by Goll. Srinivasan ‘101 also teaches at par. [0069] that the velocity of fluid 108 from microjet 114 can be adjusted to determine the injection depth and therefore it would be obvious to adjust the velocity to control the delivery depth because it is well-known in needleless delivery to do so.
In further regard to the new limitations “the controller further configured to automatically select a delivery profile from a plurality of stored delivery profiles based on the species of the subject identified from the detectable marker, wherein the first predetermined depth of delivery and the second predetermined depth of delivery in the delivery profile are selected according to the species of the subject and the delivery location on the subject”, the examiner maintains that the combination of references teaches such limitations. Hunter ‘827 teaches different custom injection pressure profiles for different situations (see par. [0102]) and further teaches creating a library of profiles (see par. [0103]), and further saving the injection profiles to be later recalled to be used in a particular situation (see par. [0104]). This disclosure is interpreted as a plurality of stored delivery profiles that can be automatically recalled when needed. The other references provide the further teachings. Spicola already teaches a system in which an information reading device (for example, an RFID reading device) is configured to read an RFID tag on the animal, wherein the RFID tag includes identifying information about the animal (see par. [0079]). Toles, as described directly above, teaches that is already known to tailor the injection pressure and velocity to the species of animal/region of animal being injected. Incorporating the information of Toles into the system of Spicola so that the RFID tag includes identifying information about the species of animal thereby enabling the animal identification system to automatically choose the proper injection profile is well within the skill of the ordinary artisan and is suggested by the art.
In regard to claim 2, see at least the teachings of Toles and Spicola.
In regard to claim 5, Hunter discloses wherein the at least one nozzle (910) comprises at least one of an adjustable exit diameter (nozzle is 910 is covered by flip cap 980 moved by hinge 985 to control opening and closing of nozzle; see par. [0086]) and an orientation that is adjustable relative to an axis of flow through the chambers (the device is described as hand-held; see par. [0105]; the orientation of hand-held device can be easily adjusted relative to axis of flow by moving/tilting).
In regard to claim 8, D’Antonio teaches the use of dye as the identifier.
In regard to claim 10, the RFID tag of Hunter 2 and/or Spicola provides the system with information relating to the animal to make sure the proper injection is made.
In regard to claim 11, D’ Antonio teaches wherein the controller is further operable to cause the marking system to apply the identifier to the subject responsive to delivering the bolus of the injectate to the subject (see col. 7, lines 3-16 of D’Antonio).
In regard to claim 31, Hunter discloses wherein the source of the injectate (950) comprises a reservoir fixedly connected to the housing (see par. [0087]-[0091]).
In regard to claim 32, Hunter discloses wherein a source of the injectate (950) comprises a reservoir fluidly coupled to the housing by a flexible conduit (945) (see par. [0087]-[0091]).
In regard to claim 37, Hunter discloses wherein the controller (965) is further operable to initiate a cleaning cycle responsive to a final delivery of injectate, the cleaning cycle comprising discharging a volume of a fluid through the at least one nozzle (the examiner’s interpretation is that “final delivery” is simply the previous delivery of injectate; the device of Hunter is configured for multiple injections and therefore the “cleaning cycle” is interpreted as the injection after the “final delivery”).
In regard to claim 38, Hunter discloses wherein the controller (965) is further operable to collect and store data pertaining to at least one of information extracted from the detectable marker, number of subjects who have received injections, date and time of delivered injections, composition of the injectate (see par. [0059]), and an aggregate volume of injectate injected (see par. [0056]-[0059]).
In regard to claim 39, Hunter discloses a method of delivering a fluid using a needle-free injector, the method comprising: providing the needle-free injector of claim 1; and responsive to initiating an injection with the needle-free injector, causing the needle-free injector to inject a bolus of an injectate into a subject (see the rejection of claim 1 as claim 39 merely recites a method of using the device of claim 1).
In regard to claim 40, the combination provides a system in which injected animals and non-injected animals could be easily identified prior to injection via the marker. The steps of claim 40 could be performed by the operator of the injector by observing the animal.
In regard to claim 45, Hunter discloses a method of facilitating needle-free injection of a fluid, the method comprising providing the needle-free injector of claim 1 (see the rejection of claim 1 as claim 44 merely recites a method of using the device of claim 1).
In regard to claims 46-47, the combinations fails to teach to provide instructions to the user including for connecting the source of fluid to the injector.
In a similar art, Toles teaches that it is known to include instructions for use in needle-free injector kits (see par. [0009]). Toles discloses a system in which a supply syringe (21) is connected to the system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hunter with the instructions as disclosed by Toles in order to provide the user with the instructions on how to operate the device thereby making it easier to use.
Claim(s) 3-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter and D’Antonio and Hunter 2 and Spicola and Toles and Goll and/or Srinivasan ‘101 in view of Srinivasan et al. (US 2004/0260234; hereafter Srinivasan ‘234).
In regard to claim 3, the combination fails to disclose further comprising a plurality of chambers constructed and arranged to be fluidly coupled to a respective plurality of sources of injectates and in regard to claim 4, Hunter fails to disclose further comprising a plurality of plungers disposed within the respective plurality of chambers.
In a similar art, Srinivasan ‘234 discloses a microjet device (100) with one chamber (120) and one nozzle (114) and another embodiment of the microjet device (200) with a plurality of chambers (220) and a plurality of nozzles (214) with a plurality of plungers (218). Srinivasan teaches that plurality of chambers can deliver a larger quantity of a substance across a larger surface area of biological barrier than single microjet 104 of FIG. 1. Furthermore, the array of microjets 204 can deliver multiple substances and/or deliver substances in a pattern to optimize administration of a particular substance through biological barrier 130. (see par. [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single chamber configuration of Hunter with the multiple chamber configuration of Srinivasan ‘234 in order to provide the increased medicament quantity and/or combination of medicaments and/or pattern of delivery as taught by Srinivasan ‘234.
In regard to claim 6, the combined teaching would provide a device with a controller that is further operable to operate the plungers according to a plurality of delivery profiles. Hunter teaches incorporating multiple delivery profiles (see citations above) and Srinivasan teaches optimized patterns of delivery (see par. [0062]).
Claim(s) 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter and D’Antonio and Hunter 2 and Spicola and Toles and Goll and/or Srinivasan ‘101 in view of Hunter et al. (US 2007/0129693; hereafter Hunter 3).
In regard to claim 33, the combination fails to teach further comprising at least one light source constructed and arranged to illuminate a mark onto an area of the subject.
In a similar art of needleless injectors, Hunter 3 discloses at least one light source (120) constructed and arranged to illuminate a mark onto an area of the subject (see par. [0004] and [0026]-[0030]).
It would have been obvious one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hunter with the light source as disclosed by Hunter 3 in order to provide a means for targeting an injection area (see at least par. [0004] and [0026]-[0030]).
In regard to claim 34, Hunter fails to disclose further comprising a graphical display integrated into the housing operatively coupled to the controller, the graphical display configured to display to a user information pertaining to at least one of the status of the needle- free injector and an injection process.
In a similar art, Hunter 3 discloses the needle-free injector 110 includes a user interface 220 that provides a status of the device. The user interface may provide a simple indication that the device is ready for an actuation. For example, a light emitting diode (LED) coupled to a controller 208 can be enabled when sufficient conditions are satisfied for an injection. More elaborate user interfaces 220 can be included to provide more detailed information, including a liquid crystal display (LCD), cathode ray tube (CRD), charge-coupled device (CCD), or any other suitable technology capable of conveying detailed information between a user and the needle-free injector 110. Thus, user interface 220 may also contain provisions, such as a touch screen to enable an operator to provide inputs as user selections for one or more parameters. For example, one might measure and record the intraocular pressure of the eye. A user may identify various parameters related to dose, sample, or parameters of the eye. The user interface 220 can alternatively be positioned on the housing 140 as described in FIG. 1, if the needle-free injector 110 is positioned within the housing 140. See par. [0040].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hunter with the graphical user interface of Hunter 3 in order to provide a convenient means for providing various status information of the injection and injector to the user.
In regard to claims 35 and 36, Hunter and Hunter 3 both disclose the use of rechargeable batteries and volume of drug deliveries.
Response to Arguments
In response to the applicant’s argument that the references fail teach the newly added limitations into claim 1, the examiner respectfully disagrees. Hunter ‘827 teaches different custom injection pressure profiles for different situations (see par. [0102]) and further teaches creating a library of profiles (see par. [0103]), and further saving the injection profiles to be later recalled to be used in a particular situation (see par. [0104]). This disclosure is interpreted as a plurality of stored delivery profiles that can be automatically recalled when needed. The other references provide the further teachings. Spicola already teaches a system in which an information reading device (for example, an RFID reading device) is configured to read an RFID tag on the animal, wherein the RFID tag includes identifying information about the animal (see par. [0079]). Toles, as described directly above, teaches that is already known to tailor the injection pressure and velocity to the species of animal/region of animal being injected. Incorporating the information of Toles into the system of Spicola so that the RFID tag includes identifying information about the species of animal thereby enabling the animal identification system to automatically choose the proper injection profile is well within the skill of the ordinary artisan and is suggested by the art.
Conclusion
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783