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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/11/2026 has been entered.
The claim amendments filed 06/11/2026 are non-compliant according to C.F.R. 1.121 (see MPM 714). For compact prosecution, the examiner is examining the claims as follows:
1. (Currently Amended) A device for dispensing a fluid product comprising a body and a dispensing head provided with a dispensing orifice and axially movable with respect to said body during actuation, said body receiving a vessel containing one or two doses of fluid product, said device comprising an electronic module which comprises a wireless communication module, a geographical location module, and a power source, wherein said device comprises a sensor system for automatically detecting and signaling handling representative of an attempt to actuate said device, said sensor system comprising at least one first sensor arranged on said dispensing head and at least one second sensor arranged on said body, said sensor system detecting handling representative of an attempt to actuate said device; wherein, before actuation, said electronic module is switched off or in standby mode, with a zero or minimum energy consumption; wherein said electronic module is switched on or awakened by said sensor system to go from its standby or switched off mode to an active mode; wherein said dispensing head includes a radial flange configured to receive one or more fingers of a user during actuation, said at least one first sensor being disposed on said radial flange; wherein said body includes a distal axial wall on which the user places one or more fingers during actuation, said at least one second sensor being disposed on said distal axial wall; and wherein said electronic module comprises timeout means to postpone the automatic emergency call by a timeout of a few seconds from detecting an attempt to actuate the device by the sensor system, said timeout means adapted to deactivate said automatic emergency call if, during the timeout, the device is
2. (Previously Presented) The device according to claim 1, wherein said at least one first sensor is a microcurrent sensor, a capacitive sensor, an infrared sensor, a luminosity sensor, an audio sensor, a temperature sensor or a humidity sensor.
3. (Previously Presented) The device according to claim 1, wherein said at least one second sensor is a microcurrent sensor, a capacitive sensor, an infrared sensor, a luminosity sensor, an audio sensor, a temperature sensor or a humidity sensor.
9. (Previously Presented) The device according to claim 1, wherein said vessel comprises a hollow tube having a proximal axial opening that is closed by a stopper that is adapted to slide in leak-tight manner in said tube during actuation.
10. (Previously Presented) The device according to claim 1, wherein said dispensing head comprises a hollow cannula connected on one side to said dispensing orifice and provided on the other side with a perforator tip provided with an opening for piercing said stopper.
11. (Previously Presented) The device according to claim 1, wherein said fluid product is a liquid.
12. (Previously Presented) The device according to claim 1, wherein said fluid product is a powder.
13. (Previously Presented) The device according to claim 1, wherein said vessel contains one single dose of fluid product, dispensed in one single actuation.
14. (Previously Presented) The device according to claim 1, wherein said vessel contains two doses of fluid product, dispensed in two successive actuations.
15. (Previously Presented) The device according to claim 1, wherein the wireless communication module is a GSM module or a wireless communication module for short- range device-to-device communication, or a wireless communication module for local area networking and internet access.
16. (Previously Presented) The device according to claim 1, wherein geographic location module is a GPS module and/or an antenna array.
17. (Previously Presented) The device according to claim 1, wherein the power source is battery.
18. (Previously Presented) The device according to claim 1, wherein the distal axial wall on which the user places one or more fingers during actuation is configured to receive a thumb of the user.
Response to Arguments
This office action is responsive to Request for Reconsideration filed on 06/11/2026. As directed by the amendment: claims 1 – 3 & 9 – 18 are pending, claims 4 – 8 were previously cancelled, no claims have been added & claim 1 has been amended.
Applicant’s arguments, see Page 6 – 7, filed 06/11/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C 103 have been fully considered and are not persuasive. The applicant argues the broad interpretation is overly broad and does not meet the required limitation, however, in Paragraph 0037 of Starr discloses the sensor can detect when the medication device is utilized which is considered to meet the limitation of actuated.
Applicant’s arguments, see Page 6 – 7, filed 06/11/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C 103 have been fully considered and are not persuasive. The applicant argues Starr does not disclose the sensors are activated simultaneously, however, it is explained in the office action that based on the modifications of Petit that disclose various sensors found in the body of the device it would be obvious to be able to sense two contact points.
Applicant’s arguments, see Page 6 – 7, filed 06/11/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C 103 have been fully considered and are not persuasive. The applicant argues Liu does not disclose the limitation of deactivating the call, however, this was not submitted in the previous examination and must be considered.
Applicant’s arguments, see Page 6 – 7, filed 06/11/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C 103 have been fully considered and are not persuasive. The applicant argues claim 11 is allowable based on the dependency of claim 1, however, claim 1 is still considered to be rejected based on the not persuasive arguments provided.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 – 3, 9 – 10 & 12 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over PETIT et al. (WO 2016097603 A1) in view of STARR et al. (US 20170257436 A1), PRIBITKIN et al. (WO 2013154954 A1), SLEVIN et al. (US 9402954 B1), SCHWEIKERT et al. (US 20160193408 A1), GRAF et al. (US 5257726 A), Agard et al. (US 9814832 B2), LIU et al. (CN 102626533 A) & Sleving et al. (US 9402954 B1).
Regarding claim 1, A device for dispensing a fluid product comprising a body 1 and a dispensing head 2 provided with a dispensing orifice 3 and axially movable with respect to said body during actuation (Page 2, Paragraph 4), said body 1 receiving a vessel 10 containing one or two doses of fluid product (Page 2, Paragraph 4)
Petit does not disclose said device comprising an electronic module which comprises a wireless communication module, a geographical location module, and a power source, wherein said device comprises a sensor system for automatically detecting and signaling handling representative of an attempt to actuate said device, said sensor system comprising at least one first sensor arranged on said dispensing head and at least one second sensor arranged on said body, said sensor system detecting handling representative of an attempt to use actuate said device when said first and second sensors are activated simultaneously, said wireless communication module being designed to make an automatic emergency call to an emergency number when said sensor system detects handling representative of an attempt to use actuate said device.
Starr discloses said device comprising an electronic module 116 which comprises a wireless communication module 106 (Paragraph 0033), a geographical location module (Paragraph 0035).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include said device comprising an electronic module which comprises a wireless communication and a geographical location module in order to be able to receive and send process data to a medical server including the usage of the medication device and the location of the device. (Abstract) The electronic module will allow the real-time monitoring and tracking of the patient’s medication usage using remote communication and allows for the facilitation of the delivery of enhanced specialized medical services to the patient. (Paragraph 0023)
Pribitkin discloses a power source (Paragraph 0057 - 0058)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include a power source as it powers the wireless signal generator that has a stable operating life comparable to the expiration term of the fluid medicaments in the cartridge. (Paragraph 0058)
Starr discloses wherein said device comprises a sensor system for automatically detecting and signaling handling representative of an attempt to actuate said device. (Paragraph 0037, 0039 & 0048)
It would have been prima facie obvious to one of ordinary skill in the art prior the effective filling date to modify Petit to have characterised in that said device comprises a sensor system for automatically detecting and signalling handling representative of an attempt to use said device in order to provide patient-specific date detected and /or collected when the user uses the biometric device. After the handling representative is detected, this could be by grasping the device or by the force detected by the pressure sensor, the information is sent remotely to the medical server. (Paragraph 0039). This allows a medical professional such as a doctor or nurse can monitor the patient’s biometric data remotely and adjust medication dosage based on the biometric information. (Paragraph 0048)
Starr discloses said sensor system comprising at least one first sensor arranged on said dispensing head and at least one second sensor arranged on said body (Figure 2 discloses various sensors 102 found in the body and the dispensing head / see annotated Figure 2)
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Figure 2: Annotated Figure 2 of App. US 2017/0257436 A1
It would have been prima facie obvious to one of ordinary skill in the art prior the effective filling date to modify Petit to include a sensor system comprising at least one first sensor arranged on said dispensing head in order to ensure the detection of contact when the surface is contacted, opened or closed. (Paragraph 0037)
Slevin discloses at least one second sensor 325 arranged on said body 105. (Column 4, lines 27 – 30)
It would have been prima facie obvious to one of ordinary skill in the art prior the effective filling date to modify Petit to include at least one second sensor arranged on said body in order to determine if a finger has been in direct contact with the body of the device and initiate the process. (Column 4, lines 27 – 37)
Modified Petit discloses said sensor system 102 (Starr) detecting handling representative of an attempt to use said device when said first (Starr) and second sensors 325 (Slevin) are activated.
Modified Petit does not expressly disclose wherein the sensors are activated simultaneously.
However, Starr further discloses the contact element of the sensor is configured to detect and generate a signal or indication when a surface is contacted. (Paragraph 0037)
Based on the teachings of Modified Petit the first sensor is located in the dispensing head and the second sensor is on the body it is obvious to one of ordinary skill that when the device is in use both sensors are being contacted by the patient at the same time. The head because it needs to be in contact with the patient and the body as it is how the patient will hold the device in place and use it. (Starr, Paragraph 0011)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to further modify Petit wherein said sensor system detecting handling representative of an attempt to use said device when said first and second sensors are activated simultaneously as the purpose of the system is to indicate that it is being used and based on the contact points it allows the assured contact in those specific places. (Starr, Paragraph 0038)
Schweikert discloses said wireless communication module 150 being designed to make an automatic emergency call to an emergency number when said sensor system 152 & 154 detects handling representative of an attempt to actuate said device (Paragraph 0005 - 0006)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include a wireless communication module being designed to make an automatic emergency call to an emergency number when said sensor system detects handling representative of an attempt to use said device in order to condense the process to two simple steps, inject and call 911. This alerts medical responders automatically and remove one step from the procedure to reduce the chances of human error. This makes it easier by having the injector to sense the use of the device an automatically make the call. (Paragraph 0005)
Modified Petit discloses an electronic module 116.
Modified Petit does not disclose wherein, before actuation, said electronic module is switched off or in standby mode, with a zero or minimum energy consumption.
Agard discloses wherein, before actuation, said electronic module 400 is switched off or in standby mode, with a zero or minimum energy consumption. (Column 12, lines 1 – 7)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling sate to further modify Petit to include wherein, before actuation, said electronic module is switched off or in standby mode, with a zero or minimum energy consumption as this would include a safety feature that prevents accidental operation that can maintain the energy contained in the power source during storage and transportation. (Column 12, lines 1 – 7)
Modified Petit does not disclose wherein said electronic module is switched on or awakened by said sensor system to go from its standby or switched off mode to an active mode.
Agard discloses wherein said electronic module 400 is switched on or awakened by said sensor system 24 to go from its standby or switched off mode to an active mode. (Column 11, lines 52 – 61)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to further modify Petit to include wherein said electronic module is switched on or awakened by said sensor system to go from its standby or switched off mode to an active mode as it would ensure that the interfaces between the power and control system of the pump are not engages or connected until activation by the user. as this would include a safety feature that prevents accidental operation that can maintain the energy contained in the power source during storage and transportation. (Column 12, lines 1 – 7)
Modified Petit discloses dispensing head 2 and a first sensor 102.
Petit further teaches a radial flange on which the user places one or more fingers during actuation. (Figure 1 discloses two flanges that extend from element ‘2’ where the user puts the fingers to activate)
Modified Petit does not expressly disclose at least one first sensor being disposed on said radial flange.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective date to further modify Petit to include at least one first sensor being disposed on said radial flange. This is as Starr has disclosed that the sensors work by having the user touch the body or dispenser head of the invention to begin communication. By having the sensor be in the radial flange when the finger touches the head the sensor would automatically work. (Starr, Paragraph 0040) Furthermore, the courts have held that rearrangement of parts requires only ordinary skill in the art and hence is considered a routine expedient. “In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950): Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.” MPEP § 2144.04-VI-C. Likewise, by placing the sensor on the flange instead of the mouth area it would still allow the sensor system disclosed by Starr to work.
Modified Petit discloses wherein said body 1 includes a distal axial wall (Abstract) and at least one second sensor. (as claimed in claim 1)
Modified Petit does not disclose wherein the user places one or more fingers, typically the thumb, during actuation, said at least one second sensor being disposed on said distal axial wall.
Graf discloses wherein the user places one or more fingers, typically the thumb, during actuation (Column 4, last paragraph – Column 5, line 1)
It would have been prima facie obvious to one of ordinary skill in the art to further modify Petit to include wherein the user places one or more fingers, typically the thumb, during actuation as the distal axis wall would provide a surface that can reliably support the thumb cupula of a hand. (Column 4, last paragraph – Column 5, line 1)
Starr does not expressly disclose said at least one second sensor being disposed on said distal axial wall.
However it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to further modify Petit to have said at least one second sensor being disposed on said distal axial wall. This is as Starr has disclosed that the sensors work by having the user touch the body or dispenser head of the invention to begin communication. By having the sensor be in the dial axial wall when the thumb touches the body the sensor would automatically work. (Starr, Paragraph 0040) Furthermore, the courts have held that rearrangement of parts requires only ordinary skill in the art and hence is considered a routine expedient. “In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950): Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.” MPEP § 2144.04-VI-C. Likewise, by placing the sensor specifically on the distal axial wall of the body it would still allow the sensor system disclosed by Starr to work.
Modified Petit discloses an electronic module 116 that sends automatic emergency call.
Modified Petit does not comprise timeout means to postpone the automatic emergency call by a timeout of a few seconds from detecting an attempt to actuate the device by the sensor system, said timeout means adapted to deactivate said automatic emergency call if, during the timeout, the device is actuated by the user.
Liu does not discloses comprising timeout means to postpone by a few seconds from detecting an attempt to use by the sensor system.
However, it does disclose a setting up time and protocol in order to generate the distress call. (Paragraph 0064)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to further modify Petit to include timeout means to postpone by a few seconds from detecting an attempt to use by the sensor system in order to show the patient is continuously using the device. (Paragraph 0064)
Sleving discloses a timeout of 15 seconds to allow the emergency call to be cancelled. (Column 6, Paragraph 2)
Sleving does not expressly disclose said timeout means adapted to deactivate said automatic emergency call if, during the timeout, the device is actuated by the user.
However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to further modify Petit to include said timeout means adapted to deactivate said automatic emergency call if, during the timeout, the device is actuated by the user as the emergency call can be triggered by the use of the device, but it can be given time after the trigger to be cancelled. It would be obvious to allow the cancelation of the call if the actuation is done on the patient and the situation is mitigated. (Column 6, Paragraph 2)
Regarding claim 2, Modified Petit discloses the device as claimed in claim 1.
Modified Petit discloses at least one first sensor.
Agard further discloses wherein said at least one first sensor is a capacitive sensor. (Column 11, lines 24 – 31)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include wherein said at least one first sensor is a capacitive sensor as the capacitive sensor must detect tissue before permitting activation. (Column 11, lines 24 – 31)
Regarding claim 3, discloses the device as claimed in claim 1.
Modified Petit discloses at least one second sensor.
Agard further discloses wherein said at least one second sensor is a capacitive sensor. (Column 11, lines 24 – 31)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include wherein said at least one second sensor is a capacitive sensor as the capacitive sensor must detect tissue before permitting activation. (Column 11, lines 24 – 31)
Regarding claim 9, Modified Petit discloses the device as claimed in claim 1.
Modified Petit discloses wherein said vessel 10 comprises a hollow tube 11 having a proximal axial opening that is closed by a stopper 20 that is adapted to slide in leak-tight manner in said tube 11 during actuation. (Petit, Page 3, last sentence – Page 4, Paragraph 1 & 2)
Regarding claim 10, Modified Petit discloses the device as claimed in claim 1.
Modified Petit discloses wherein said dispensing head 2 comprises a hollow cannula 4 connected on one side to said dispensing orifice 3 and provided on the other side with a perforator tip 5 provided with an opening for piercing said stopper 20. (Petit, Page 4, Paragraph 2)
Regarding claim 12, Modified Petit discloses the device as claimed in claim 1.
Modified Petit does not disclose wherein said fluid product is a powder.
Starr discloses wherein said fluid product is a powder (Paragraph 0038)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include wherein said fluid product is a powder as it a known alternative medication delivery device in the art for treating emergency and/or other medical conditions. (Paragraph 0036)
Regarding claim 13, Modified Petit discloses the device as claimed in claim 1.
Modified Petit discloses wherein said vessel 10 contains one single dose of fluid product, dispensed in one single actuation. (Petit, Page 3, Paragraph 8)
Regarding claim 14, Modified Petit discloses the device as claimed in claim 1.
Modified Petit discloses wherein said vessel 10 contains two doses of fluid product, dispensed in two successive actuations. (Petit, Page 3, Paragraph 9)
Regarding claim 15, discloses the device as claimed in claim 1.
Modified Petit does not disclose wherein the wireless communication module is a GSM module or a wireless communication module for short-range device-to- device communication, or a wireless communication module for local area networking and internet access.
Starr discloses wherein the wireless communication module is a wireless communication module for local area networking and internet access. (Paragraph 0033)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Petit to include wherein the wireless communication module is a wireless communication module for local area networking and internet access as the module will allow the real-time monitoring and tracking of the patient’s medication usage using remote communication and allows for the facilitation of the delivery of enhanced specialized medical services to the patient. (Paragraph 0023)
Regarding claim 16, Modified Petit discloses the device as claimed in claim 1.
Modified Petit does not disclose wherein geographic location module is a GPS module and/or an antenna array.
Starr discloses wherein geographic location module is a GPS. (Paragraph 0035).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include wherein geographic location module is a GPS module in order to ensure the medical service provider is able to locate the patient when the medication is misplaced. (Paragraph 0028)
Regarding claim 17, Modified Petit discloses the device as claimed in claim 1.
Modified Petit does not disclose wherein the power source is battery.
Pribitkin discloses a power source, such as a battery (Paragraph 0057 - 0058)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filling date to modify Petit to include a power source, such as a battery as it powers the wireless signal generator that has a stable operating life comparable to the expiration term of the fluid medicaments in the cartridge. (Paragraph 0058)
Regarding claim 18, Modified Petit discloses the device as claimed in claim 1.
Modified Petit discloses wherein the distal axial wall on which the user places one or more fingers during actuation is configured to receive a thumb of the user.
Graf discloses wherein the distal axial wall on which the user places one or more fingers during actuation is configured to receive a thumb of the user. (Column 4, last paragraph – Column 5, line 1)
It would have been prima facie obvious to one of ordinary skill in the art to further modify Petit to include wherein the distal axial wall on which the user places one or more fingers during actuation is configured to receive a thumb of the user as the distal axis wall would provide a surface that can reliably support the thumb cupula of a hand. (Column 4, last paragraph – Column 5, line 1)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over PETIT et al. (WO 2016097603 A1) in view of STARR et al. (US 20170257436 A1), PRIBITKIN et al. (WO 2013154954 A1), SLEVIN et al. (US 9402954 B1), SCHWEIKERT et al. (US 20160193408 A1), GRAF et al. (US 5257726 A), Agard et al. (US 9814832 B2) & LIU et al. (CN 102626533 A) as claimed in claim 1, in further view of Farrugia et al. (WO 0193926 A2).
Regarding claim 11, Modified Petit discloses the device as claimed in claim 1.
Modified Petit does not disclose wherein said fluid product is a liquid.
Farrugia discloses wherein said fluid product is a liquid. (Page 2, lines 6 – 10)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Petit wherein said fluid product is a liquid as it is a known alternative medication useful in self-administration to treat anaphylactic shock, heart attack, exposure to toxic agents, or other emergency medical conditions. (Page 2, lines 6 – 10)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACIELA NATALIA LEBRON DE JESUS whose telephone number is (571)270-3892. The examiner can normally be reached Mon - Fri 8:00-5:00 CST.
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/GRACIELA NATALIA LEBRON DE JESUS/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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