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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
reference numeral “4d” in [0068] not shown;
reference numeral “6” and “7” as per [0075-0076] are not shown in drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 is objected to because of the following informalities: “modules” should be “module”. Appropriate correction is required.
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 1-14 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 is positively claiming the “the supplemental device” in line 9. However, there is no antecedent basis for this limitation in the body of the claim. It is mentioned in the preamble, but this is considered intended use. The examiner will interpret this limitation as “a supplemental device” in line 9.
Appropriate correction is required.
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.
Claims 1, and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagar et al (WO 2014/064691 A2).
Regarding Claim 1: Nagar discloses A system for activating a supplemental device (202) attached to a medicament delivery device (106) comprising:
- a medicament delivery device (106) (Figs. 5-7) comprising:
- a housing (body of injector device 106);
- a medicament container positioned within the housing [025]; and
- a dose delivery outlet (needle 114) accessible through a terminal end of the housing (needle in Fig. 6C),
- a removable cap (130) attached to the housing such that the dose delivery outlet (114) is prevented from being accessible unless the cap (130) is fully removed from the medicament delivery device (106) (Figs. 6B -6C);
- a supplemental device (202) comprising: - a battery source (102,192,196) attached to the housing, where the battery source is configured to activate the supplemental device 202;
- a communication module (transmitter/transponder in [93]) configured to transmit data to an external device [093], where the data comprises information directly related to a status of the supplemental device, wherein the supplemental device 202 is initially in a first state where the communication module is prevented to receive power from the power source (192,196) and where movement of the cap relative to the housing changes the supplemental device to a second state where the power source provides power to the communication module: "When a user removes the cap 130 to inject the drug, the activation pin 212 disconnects from the switch 188 and this turns on the electrical components of the circuit on the sleeve part which fits the injection device body. This may be configured to thereby activate the microphone 144, the transmitter and/or transponder, and in some embodiments, the processor 180, to measure the amount of drug that was injected and transmits the data to the external unit 154."), where the data comprises the information directly related to the status of the switch,
wherein the switch is initially in a first state where the communication module is prevented to receive power from the battery and where movement of the cap (130) relative to the housing changes the switch to a second state where the battery provides power to the communication module (transmitter/ transponder in [93]). (See [079]: "In some embodiments, the pin 212 may comprise an activation pin configured to turn on the switch 188 upon disconnection of the first portion 214 from the second portion 218 via appropriate electrical circuitry and components.". In [080]: "As seen in Figure 6B, the first and second portions 214 and 218 may be connected and the sensor has yet to commence its operation.
Upon removal of cap 130, the first and second portions 214 and 218 are disconnected, as seen in Figures 6C and 7, thereby triggering the detection operation, which may operate as described in reference to Figures 1- 5.
In this embodiment, the operating of the tracking device 102 is switched on or off in a simple manner due to the simple, mechanical operation of the pins 212."). Note that the mere fact that the transmitter/transponder transmission is triggered by removing the cap, this insofar convey the respective "status of the switch" corresponding to cap status.”.
Regarding Claim 5: the attachment of the power source and of the communication module are capable to be permanent such that the housing and the battery source are disposable and are prevented to be separated from each other without destroying the housing or the modules.
Regarding Claim 6: the power source or the communication module comprises one or more sensors [08, 011, 013, 095] configured to detect a motion of at least one of the components of the medicament delivery device.
Regarding Claim 7: the system further comprises a sensor module 140 connectable to one or more components of the medicament delivery device, and wherein said sensor module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device [08, 011, 013, 095].
Regarding Claim 8: any of the modules, for example 102, is removable from the housing and is capable of being reusable.
Regarding Claim 9: the power source or the communication module comprises a recorder configured to obtain and store data information about the medicament delivery device [06, 13, 49, 52, 56].
Regarding Claim 10: the data transmission by the communication module starts when the recorder receives power from the power source [010, 011, 091].
Regarding Claim 11: the system further comprises a logging module connectable to one or more components of the medicament delivery device, and wherein the logging module is configured to start tracking motion of the medicament delivery device when the cap is removed [05, 07, 094].
Regarding Claim 12: the system further comprises a memory module connectable to one or more components of the medicament delivery device, and wherein the memory module is configured to store the data and the communication module is configured to transmit the data wirelessly to the external device [06, 07, 012, 013, 054, 090-092, 094, 095].
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauss et al (WO 2016055351 A1).
Regarding Claim 1: A system for activating a supplemental device attached to a medicament delivery device comprising:
a medicament delivery device (figs. 2a-2b) comprising:
a housing 43;
a medicament container 70 positioned within the housing; and
a dose delivery outlet (not shown) accessible through a terminal end of the housing,
a removable cap 44 attached to the housing such that the dose delivery outlet is prevented from being accessible unless the cap is fully removed from the medicament delivery device;
a supplemental device comprising:
a power source (Figs 4-5) attached to the housing, wherein the power source is configured to activate the supplemental device; and
a communication module (52,54; p12-13) configured to transmit data to an external device, where the data comprises information directly related to a status of the supplemental device, wherein the data comprises the information directly related to the status of the switch, the supplemental device is initially in a first state where the communication module is prevented to receive power from the power source and where movement of the cap relative to the housing changes the supplemental device to a second state where the power source provides power to the communication module (p12, lines 21-30).
Regarding Claims 2-3, the supplemental device is configured to be in the first state only once, or the supplemental device is prevented to transform from the second state back to the first state (p7, lines 1-8; p13, lines 19-27; figs 3-5).
Regarding Claim 4, the supplemental device further includes a switch (strip) operatively connected to the power module, and wherein activation of the switch is configured to transition the supplemental device from the first state to the second state (p4, line 23 - p5, line2; p12, lines 21-30).
Regarding Claim 5, the attachment of the power source and of the communication module are permanent such that the housing and the power source are capable of being disposable and are prevented to be separated from each other without destroying the housing or the modules.
Regarding Claims 6-7, wherein the power source or the communication module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device; and the system further comprises a sensor module 80 (fig 8) connectable to one or more components of the medicament delivery device, and wherein the sensor module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device (page 16, lines 13-23).
Regarding Claims 8, 13, and 14, the power source is removable from the housing and is capable of being reusable; the power source comprises a photovoltaic panel, and the power source comprises a coin battery (page 3 lines 28-31).
Regarding Claims 9-10, the power source or the communication module comprises a recorder configured to obtain and store data information about the medicament delivery device (p10, line 32 – p11, line14) and the data transmission by the communication module starts when the recorder receives power from the power source (p3, line 28 – p4, line 6).
Regarding Claim 11, the system further comprises a logging module connectable to one or more components of the medicament delivery device, and wherein the logging module is configured to start tracking motion of the medicament delivery device when the cap is removed (p18, lines 16-25).
Regarding Claim 12, the system further comprises a memory module connectable to one or more components of the medicament delivery device, and wherein the memory module is configured to store the data and the communication module is configured to transmit the data wirelessly to the external device (p3, lines 9-14; p12, lines 8-19).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights