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 .
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 1-20 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.
Claim 1 recites “An electronic module connectable to an autoinjector or the autoinjector with the electronic module, the electronic module configured to detect and to monitor a dose administering process with the autoinjector” in lines 1-4. It is unclear where the preamble of the claim ends and where the body of the claim begins and for this reason it is unclear what structures are required by the claim. Also, assuming the claim body of the claim begins after “an autoinjector” limitation then the claim only appears to require the electronic module and the function the electronic module performs and not the autoinjector itself. For purposes of examination, it is interpreted that the claims require the autoinjector and the electronic module, however the applicant should amend the claim to clarify.
Claims 2-20 recite “the electronic module or the autoinjector” in the preamble of the claims, however in line two of each dependent claim the claims all appear to only further define the “electronic module”. It is unclear the scope of the claim. For example, in the situation there is art that teaches the autoinjector, would there be no need to read on the limitations of the electronic module since the preamble is an “or” recitation, or is this product claim a system requiring both an electronic module and autoinjector, and the dependent claims that are further defining the electronic module portion of the system. For purposes of examination, it is interpreted that the claims require the autoinjector and the electronic module, however the applicant should amend the claim to clarify.
Claim 12 recites “wherein the electronic module is a separate add-on module configured to be coupled releasably to the” in lines 2-3, without completing the limitation of what the electronic module is configured to be coupled to. For purposes of examination it is interpreted that the limitation is “wherein the electronic module is a separate add-on module configured to be coupled releasably to the autoinjector”, however the applicant should amend the claim to clarify.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6-15 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melzi (WO 2019121607).
Regarding Claim 1, Melzi teaches (Figs 2a-2b, 11) An electronic module (200, Figs 2a-2b) connectable to an autoinjector (10), the electronic module configured to detect and to monitor a dose administering process (fig 11, steps 502 and 503) with the autoinjector or parameters related to the dose administering process and to provide feedback (Fig 11, step 505 where information is transferred to the external device) on the dose administering process or the parameters related to the dose administering process (Pg. 21 lines 15-26 teaches that the start and end of the dose is sent to the user).
Regarding Claim 6, Melzi teaches the electronic module or the autoinjector of claim 1, wherein the electronic module comprises an active wireless communicator (240, Bluetooth communication in Fig 3; examiner notes instant application Pg. 6 of the originally filed specification states that active wireless communication can be based on Bluetooth) configured to transmit information actively wirelessly to a user device (1000, see Fig 4).
Regarding Claim 7, Melzi teaches the electronic module or the autoinjector claim 1, wherein the electronic module comprises a passive wireless communicator (240 can be a NFC communicator see Pg. 10 lines 20-25; the examiner notes that instant application Pg. 6 of the originally filed specification states that passive wireless communication is preferably based on NFC) configured to transmit information passively wirelessly to a user device (1000, Fig 4).
Regarding Claim 8, Melzi teaches the electronic module of the autoinjector claim 1, wherein the electronic module comprises an optical notifier (231) configured to directly display information to a user of the autoinjector (Pg. 10 lines 25-30).
Regarding Claim 9, Melzi teaches the electronic module or the autoinjector of claim 1, wherein the electronic module comprises a micro- controller (24) and a power supply (212), and the micro-controller is configured to receive information about the administering process (receiving information from 254, 251; see Pg. 12 lines 19-25 and Pg. 17 lines 8-30), to process the information and to control an output of user feedback based on the information (output information via 230-234 (See Pg. 10 lines 25-35) and 240-241 (Pg. 10 lines 12-14)).
Regarding Claim 10, Melzi teaches the electronic module or the autoinjector of claim 9, wherein the electronic module comprises a wake switch coupled to the micro-controller and configured to switch an operation state of the micro-controller between an ON state and an OFF state (See Pg. 11 lines 30-35 teaching that there is a wake up signal sent to device 1000 activate the device from the resting state to the active state this is considered to be a switch to operate the controller between the ON state and an OFF state).
Regarding Claim 11, Melzi teaches the electronic module or the autoinjector of claim 1, wherein the electronic module (200) is an integral component of the autoinjector non-releasably coupled to components of the autoinjector (See Pg. 7 lines 20-25 teaching that the module 200 snaps into place to allow the device to be retained on the injection device and other attachment means include adhesive surfaces or any suitable means).
Regarding Claim 12, Melzi teaches the electronic module or the autoinjector of claim 1, wherein the electronic module (200) is a separate add-on module configured to be coupled releasably to the autoinjector (See 112 rejection above; see Pg. 7 lines 20-25 teaching various coupling methods including threading as an option, it is interpreted that threading would allow for a releasable coupling method as an alternative to an adhesive that may be more permanent).
Regarding Claim 13, Mezli teaches the electronic module or the autoinjector of claim 12, wherein the electronic module (200) comprises an attachment switch (106) configured to detect attachment of the electronic module to the autoinjector (Pg. 11 lines 5-10), a component of the autoinjector comprises a barcode or QR code containing information about a drug within the autoinjector and configured to be read by a user device (Pg. 6 lines 30-36), or the electronic module comprises a mechanical coding feature enabling attachment of the electronic module to autoinjectors only including a matching mechanical coding feature (the examiner is interpreting the claim as requiring either the attachment switch, the “component” comprising a barcode or QR code, or the “mechanical coding”, since Mezli teaches the first two, Mezli meets the limitations of this claim).
Regarding Claim 14, Melzi teaches the electronic module or the autoinjector of claim 1, wherein the autoinjector is a single use fixed dose autoinjector or one of a single use variable dose autoinjector, a multiple use fixed dose autoinjector and a multiple use variable dose autoinjector (See Pg. 1 lines 24-35 teaching different types of injector devices including autoinjectors for single use and multiple use).
Regarding Claim 15, Melzi teaches the electronic module or the autoinjector of claim 1, wherein the electronic module (200) is configured to detect and to monitor the dose administering process with the autoinjector or the parameters related to the dose administering process based on at least one of, a movement status of one or more moving parts of the autoinjector and a position of the one or more moving parts of the autoinjector (See Pg. 12 lines 18-25 teaching sensors 251 detect movement of the plunger) .
Regarding Claim 20, Melzi teaches the electronic module or the autoinjector of claim 1, wherein the electronic module comprises an active wireless communicator (240) configured to transmit information actively wirelessly to a user device, the active wireless communication being based on the "cellular" communication technology SigFox, on the "cellular" communication technology NB-IoT or on Bluetooth (Pg. 10 lines 20-25 teaches 240 can be Bluetooth or NFC).
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.
Claim(s) 2 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melzi (WO 2019121607) in view of Bengtsson (CN 111132713).
Regarding Claim 2, Melzi teaches all elements of claim 1 as described above. Mezli further teaches a sensor that monitors movement of a component of the autoinjector during the administering process (See Pg. 12 lines 18-25 teaching sensor 251 detects movement of plunger). Mezli does not specify wherein the electronic module comprises a photo-reflector sensor configured to monitor movement of a component of the autoinjector during the administering process.
Bengtsson teaches an autoinjector (Fig 7) that includes a plunger (260) and a piston member (270), wherein the system uses a photo sensor (290b) and a photo refector (220) to tell the distance or motion between two components (See translation Pg. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor (251) of Mezli with a photo-reflector sensor as taught by Bengtsson. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (photo-reflector sensor of Bengtsson) to obtain predictable results (monitor the movement of the plunger rod in Mezli).
Regarding Claim 16, Mezli teaches all elements of claim 1 as described above. Mezli further teaches the electronic module or the autoinjector wherein the electronic module (200) comprises a sensor (251) configured to monitor movement of a drive chassis(14 includes a drive chassis and the plunger that moves during the injection process) of the autoinjector during the administering process (See Pg. 12 lines 18-25 teaching 251 detects movement of the plunger), the drive chassis comprising an optical pattern monitored by the sensor to monitor a dispensing movement of a plunger rod (See Pg. 12 lines 18-25 teaching 251 detects movement of the plunger).
Mezli does not specify the electronic module comprises a photo-reflector sensor.
Bengtsson teaches an autoinjector (Fig 7) that includes a plunger (260) and a piston member (270), wherein the system uses a photo sensor (290b) and a photo refector (220) to tell the distance or motion between two components (See translation Pg. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor (251) of Mezli with a photo-reflector sensor as taught by Bengtsson. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (photo-reflector sensor of Bengtsson) to obtain predictable results (monitor the movement of the plunger rod in Mezli).
Claim(s) 3 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melzi (WO 2019121607) in view of Rios (WO 2017070391)
Regarding Claim 3, Mezli teaches all elements of claim 1 as described above. Mezli further teaches a sensor that monitors movement of a component of the autoinjector during the administering process (See Pg. 12 lines 18-25 teaching sensor 251 detects movement of plunger). Mezli does not specify the electronic module or the autoinjector wherein the electronic module comprises a time of flight sensor configured to monitor movement of a component of the autoinjector during the administering process.
Rios teaches (Fig 2a) an autoinjector that includes a plunger (214) and piston (212) that uses a time of flight sensor (260; see [0044] and [0052]) to tell the distance between two components (See [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor (251) of Mezli with a time of flight sensor as taught by Rios. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (time of flight sensor of Rios) to obtain predictable results (to monitor movement of the plunger rod in Mezli).
Regarding Claim 17, Mezli teaches all elements of claim 1 as described above. Mezli further teaches the electronic module or the autoinjector wherein the electronic module (200) comprises a sensor (251) configured to monitor movement of a plunger rod of a drive chassis (14 includes the drive chassis and the plunger that moves during the injection process) of the autoinjector during the administering process, the plunger rod comprising a reflective surface configured to be monitored by the sensor to monitor a dispensing movement of the plunger rod (See Pg. 12 lines 18-25 teaching how 251 detects movement of the plunger rod).
Mezli does not specify wherein the electronic module comprises an optical time of flight sensor.
Rios teaches (Fig 2a) an autoinjector that includes a plunger (214) and piston (212) that uses a time of flight sensor (260; see [0044] and [0052]) to tell the distance between two components (See [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor (251) of Mezli with a time of flight sensor as taught by Rios. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (time of flight sensor of Rios) to obtain predictable results (to monitor movement of the plunger rod in Mezli).
Claim(s) 4 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melzi (WO 2019121607) in view of Carlsson (EP 3178507).
Regarding Claim 4, Mezli teaches all elements of claim 1 as described above. Mezli further teaches a sensor that monitors movement of a component of the autoinjector during the administering process (See Pg. 12 lines 18-25 teaching sensor 251 detects movement of plunger). Mezli does not specify the electronic module or the autoinjector wherein the electronic module comprises a directional microphone configured to detect a signal sound generated by a component of the autoinjector during the administering process, such that the directional microphone is capable of monitoring movement of a plunger rod via the generated acoustic signal.
Carlsson teaches (fig 1a) an autoinjector that includes a plunger (60) and a piston (65) that uses a clicker protrusion (301, 313) in combination with a microphone (812) to tell the distance between the components (See [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor (251) of Mezli with the clicker protrusion and microphone as taught by Carlsson. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (clicker protrusion and microphone of Carlsson) to obtain predictable results (to monitor the movement of the plunger rod in Mezli).
Regarding Claim 18, Mezli teaches all elements of claim 1 as described above. Mezli further teaches the electronic module (200) comprises a sensor (251) configured to monitor movement of a plunger rod of a drive chassis (14 includes the drive chassis and the plunger that moves during the injection process) of the autoinjector during the administering process, the plunger rod comprising a reflective surface configured to be monitored by the sensor to monitor a dispensing movement of the plunger rod (See Pg. 12 lines 18-25 teaching how 251 detects movement of the plunger rod).
Mezli does not specify the electronic module or the autoinjector wherein the electronic module comprises a directional microphone configured to detect a signal sound generated by a drive chassis of the autoinjector during the administering process, the drive chassis comprising a clicker protrusion configured to generate an acoustic signal upon movement of the drive chassis in a proximal direction, such that the directional microphone is capable of monitoring movement of a plunger rod via the generated acoustic signal.
Carlsson teaches (fig 1a) an autoinjector that includes a plunger (60) and a piston (65) that uses a clicker protrusion (301, 313) in combination with a microphone (812) to tell the distance between the components (See [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor (251) of Mezli with the clicker protrusion and microphone as taught by Carlsson. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (clicker protrusion and microphone of Carlsson) to obtain predictable results (to monitor the movement of the plunger rod in Mezli).
Claim(s) 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melzi (WO 2019121607) in view of Edwards (US 20080059133).
Regarding Claim 5, Mezli teaches all elements of claim 1 as described above. Mezli further teaches a sensor that monitors movement of a component of the autoinjector during the administering process (See Pg. 12 lines 18-25 teaching sensor 251 detects movement of plunger). Mezli does not specify the electronic module or the autoinjector wherein the electronic module comprises a frangible circuit element configured to be broken when a component of the autoinjector reaches a specific position during the administering process, to monitor the administering process.
Edwards teaches (Fig 2) an injector (1002) that includes a plunger (1284) and piston (1312) and a frangible switch tab for motion between two components (see [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor (251) of Mezli such that it is a frangible tab switch as taught by Edwards. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (frangible tab switch of Edwards) to obtain predictable results (to monitor movement of the plunger rod of Mezli).
Regarding Claim 19, Mezli teaches all elements of claim 1 as described above. Mezli further teaches the electronic module or the autoinjector wherein the electronic module (200) comprises a sensor (251) configured to monitor movement of a plunger rod of a drive chassis (14 includes the drive chassis and the plunger that moves during the injection process) of the autoinjector during the administering process, the plunger rod configured to be monitored by the sensor to monitor a dispensing movement of the plunger rod (See Pg. 12 lines 18-25 teaching how 251 detects movement of the plunger rod).
Mezli does not specify the electronic module or the autoinjector wherein the electronic module comprises a frangible circuit element configured to be broken when a drive chassis of the autoinjector reaches a specific position during the administering process, to monitor the administering process.
Edwards teaches (Fig 2) an injector (1002) that includes a plunger (1284) and piston (1312) and a frangible switch tab for motion between two components (see [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor (251) of Mezli such that it is a frangible tab switch as taught by Edwards. One of ordinary skill in the art would have been motivated to do so as this is a simple substitution of one known element (sensor 251 of Mezli) for another (frangible tab switch of Edwards) to obtain predictable results (to monitor movement of the plunger rod of Mezli).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Toporek et al. (US 20200061299) teaches an electronic module attached to an autoinjector.
Helmer (US 20190201627) teaches microphone as a sensor and wireless communication with an antenna.
Searle (US 20170286638) teaches a time of flight sensor in an electronic module.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
