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 .
Response to Arguments
This office action is responsive to Request for Reconsideration files on 11/17/2025 . As directed by the amendment: claims 1 – 18 are pending, claims 4 - 8 were cancelled, claims 15 – 18 have been added & claims 1 and 9 have been amended.
Applicant’s arguments, see Page 8, filed 11/17/2025, with respect to 35 U.S.C 112 have been fully considered and are persuasive. The 112 rejection of claim 1 has been withdrawn.
Applicant’s arguments, see Page 8, filed 11/17/2025, with respect to 35 U.S.C 112 have been fully considered and are persuasive. In light of the amendments to the claims, the 112 rejection of claim 1 – 4 & 6 - 14 has been withdrawn.
Applicant’s arguments, see Page 8 - 9, filed 11/17/2025, with respect to the rejection(s) of claim 1 under 35 U.S.C 103 have been fully considered and are not persuasive. The rejections are withdrawn in light of the amendments to the claims.
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive. While none of the documents disclose the combination of sensors in the particular locations disclosed in claims 6 & 7, the modifications made to Petit are able to disclose the obvious statements as to why including those sensors in the radial flange and the distal axial wall. Including a sensor in the radial flange would have been obvious as the finger would touch the sensor automatically by touching the head. (Starr, Paragraph 0040) Including the sensor in the distal axial wall would have been obvious as the finger would automatically be sensed when touching the body of the device. (Starr, Paragraph 0040)
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive. While Petit discloses the electronic module sending the automatic emergency call, it does not disclose a timeout to postpone the call by a few seconds. However, Liu discloses the importance and obviousness of postponing the time to make sure that the patient is actually having a severe attack and did not do it by mistake. (Liu, Paragraph 0064)
Applicant’s arguments, see Page 10, filed 11/17/2025, with respect to the rejection(s) of claim 1 under 35 U.S.C 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of new limitations added.
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 – 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).
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 use 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 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 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 characterised in that said device comprises a sensor system 102 for automatically detecting and signalling handling representative of an attempt to use 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 use 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 by a few seconds from detecting an attempt to use by the sensor system.
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 there is a severe acute attack state as the patient is continuously using the device. (Paragraph 0064)
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
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 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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