Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendments
Claims 2-21 are presented for examination. Assig: Sanofi-Aventis. Priority Date: 24 March 20211.
Claim Objections
Claim 6 objected to because of the following informalities: “wherein the module is configured to be attached the an actuation button of the medical injection device.” It is believed the amendment should read: “wherein the module is configured to be attached to the [[an]] actuation button of the medical injection device.” Appropriate correction is required.
Claim Rejections – Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims (see below) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (see below) of application 17/319,508 in view of see list of copending applications listed below. Although the claims at issue are not identical, they are not patentably distinct from each other because of reasons listed below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Below are listings of the claimed invention and the relevant copending applications corresponding to the double patent rejections. All recitations to the claims of this application are emboldened.
19/083,773
2. A module for attachment to a medical injection device, the module comprising:
a switch configured to detect an actuation action of the medical injection device that comprises an actuation button, the medical injection device being configured such that the actuation action causes at least a portion of a medicament contained in the medical injection device to be ejected from the medical injection device;
an electric unit connected to the switch and configured to store and/or provide information related to the detected actuation action; and
a dose determination unit configured to detect a rotational movement of a dose dial sleeve of the medical injection device during a dose injection.
18. A system comprising a medical injection device comprising an actuation button and a module configured for attachment to the medical injection device, the module comprising:
a switch configured to detect an actuation action of the medical injection device, the medical injection device being configured such that the actuation action causes at least a portion of a medicament contained in the medical injection device to be ejected from the medical injection device;
an electric unit connected to the switch and configured to store and/or provide information related to the detected actuation action; and
a dose determination unit configured to detect a rotational movement of a dose dial sleeve of the medical injection device during a dose injection.
16/572,242 (now U.S. 11,424,026)
1. An apparatus, comprising:
a detector unit comprising a sensor configured to detect an actuation action performed by the detector unit to an actuation button of a medical device, the actuation button configured to cause the medical device to eject at least a portion of a medicament contained in the medical device, wherein the sensor is configured to detect the actuation action based on a detection of a force and/or a touch applied to the detector unit as part of the actuation action;
an electric unit connected to the sensor and configured to store and/or provide information related to the detected actuation action; and
a dose determination unit configured to sense a rotational movement of a dose dial sleeve of the medical device during a dose injection for determining a dose of the medicament.
13. A method, comprising:
detecting, by a sensor, an actuation action performed by a detector unit of an apparatus, the detector unit comprising the sensor, the actuation action being performed to an actuation button of a medical device to cause the medical device to eject at least a portion of a medicament contained in the medical device, wherein the sensor detects the actuation action based on a detection of a force and/or a touch applied to the detector unit as part of the actuation action, storing and/or providing information related to the detected actuation action, and determining, by a dose determination unit of the apparatus, a dose of the medicament at least in part by sensing a rotational movement of a dose dial sleeve of the medical device during a dose injection.
Claim 2 discloses an embodiment a switch to determine an actuation of a medical injection device, wherein the device is used to dispense medicament through injection. The embodiment further includes an electric unit coupled to the switch further used to store/dispense information regarding the detected actuation. The embodiment further includes a does determination feature to detect rotational movement related to the dose of the injected medicament.
Claim 1 discloses a similar embodiment employing a sensor to detect the actuation action of the medical device dispensing medicament. Like claim 2, claim1 discloses using an electric unit coupled to the sensor to store/dispense data concurrent to the depressing of a user’s depressing of a detector button located atop the medical device’s point of the user’s applied force. The embodiment also includes a dose determination unit including a rotatable dial sleeve used to dispense an amount of medicament related to the rotation of the dial sleeve.
Claim 2 is obvious over claim 1. While claim 2 does not disclose, word for word, the exact verbiage as claimed in claim 1, clearly, the limitations of claim 2 include analogous structural and functional elements synonymous with the embodiment disclosed in claim 1. Thus, one of ordinary skill, apprised of these structural and functional analogies, would have concluded claim 2 is an obvious variant of claim 1.
For the same reasons disclosed under item 5, claim 2 is obvious over claim 13.
For substantially similar reasons disclosed under item 5, claim 18 is obvious over claim 13.
For the same reasons disclosed under item 5, claim 18 is obvious over claim 1.
17/319,508 (now U.S. 11,862,331)
A medical device comprising:
a module comprising:
a switch configured to detect an actuation action of a medical device, the actuation action causing the medical device to eject at least a portion of a medicament in the medical device, and an electric unit connected to the switch and configured to store and/or provide information related to the detected actuation action;
a housing;
a dosage knob configured for rotation relative to the housing during dose dialing and configured not to rotate relative to the housing during dose injection; and
a dose dial sleeve, wherein the medical device is an injection device, wherein the module is attached to the dosage knob, wherein during the dose dialing, the dosage knob and the dose dial sleeve are stationary relative to one another, and during the dose injection, the dose dial sleeve rotates relative to the dosage knob, and wherein a relative rotational movement between the dose dial sleeve and the dosage knob is detected by the module during the dose injection.
6. A medical device comprising a housing; a container configured to contain a cartridge of a medicament;
a dosage selector configured to be rotated around a longitudinal axis of the medical device to select a dose of the medicament;
a dose dial sleeve configured to rotate during dose injection; and
a module comprising a detector to detect a rotational movement of the dose dial sleeve relative to the dosage selector during the dose injection, the module comprising a switch configured to detect an actuation action of a medical device, the actuation action causing the medical device to eject at least a portion of the medicament in the cartridge.
Claim 2 discloses an embodiment a switch to determine an actuation of a medical injection device, wherein the device is used to dispense medicament through injection. The embodiment further includes an electric unit coupled to the switch further used to store/dispense information regarding the detected actuation. The embodiment further includes a does determination feature to detect rotational movement related to the dose of the injected medicament.
Claim 1 discloses a medical device including a module containing a switch to detect an actuation action of the medical device ejecting a portion of medicament, an electric unit coupled to the switch and configured to store/dispense information related to the detected actuation setup, a housing for joining the above medical injection device to the cited switch and electric unit, and a rotating sleeve and a dosage knob for determining applied dosage of the medicament related to the number of rotations applied to the dose dial sleeve.
Claim 2 is obvious over claim 1. While claim 2 does not disclose, word for word, the exact verbiage as claimed in claim 1, clearly, the limitations of claim 2 include analogous structural and functional elements synonymous with the embodiment disclosed in claim 1. Thus, one of ordinary skill, apprised of these structural and functional analogies, would have concluded claim 2 is an obvious variant of claim 1.
For the same reasons indicated under item 10, claim 2 is obvious over claim 6.
For substantially similar reasons indicated under item 10, claim 18 is obvious over claim 6.
Claim Rejections 35 USC 102(a)(1)
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a) NOVELTY; PRIOR ART A person shall be entitled to a patent unless-
(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 2, 6-8, 10-14, 17-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Larsen et al., U.S. 2002/0143288 (see IDS).
On claim 2, Larsen cites:
A module for attachment to a medical injection device, the module comprising:
a switch configured to detect an actuation action of the medical injection device that comprises an actuation button,
[0036] When the button 1 is pressed the activation of the switch 18 will provide a signal which directly or indirectly triggers the circuit block 10 to activate the display 14 for a while to show the status of the timer.
the medical injection device being configured such that the actuation action causes at least a portion of a medicament contained in the medical injection device to be ejected from the medical injection device;
an electric unit connected to the switch and configured to store and/or provide information related to the detected actuation action;
[0033] The electronic circuit in the sealed circuit block 10 comprises a timer which is started when a dose is injected and the status of which is shown for a while in the display 14 when the button 1 is pressed by pressing the window 8 so that the electronic unit in the button 1 is moved against the force of a spring 19 whereby a button 20 of a switch 18 is pressed to activate said switch
and
a dose determination unit configured to detect a rotational movement of a dose dial sleeve of the medical injection device during a dose injection.
[0030] FIG. 1 shows the proximal end of an injection device comprising a combined dose setting and injection button 1, which button is rotated to set a dose and pressed in an axial direction to inject the set dose.
[0041] When energised during the injection of a set dose the Hall elements 21-24 works together with the magnet ring 7 to monitor the relative rotation of the button 1 relative to the drum 6 as the length of this rotation is proportional with the number of doses injected. In the embodiment shown in FIG. 2 this monitoring Is made by leading the output signal from the first 21 and the third 23 Hall elements to the inputs of a differential operational amplifier 25 as shown in FIG. 3. The output signal from the operational amplifier 24, which is an analogue signal proportional with the cosines of the phase angle of the rotation relative to the start position, is digitised by an AD converter 27. It shall be noticed that this phase angle is calculated relative to the magnet poles so that a rotation which brings a Hall element from a pole with one polarity to the next pole with the same polarity is defined as a phase angle of 360.degree. which in the shown example corresponds to a 60.degree. rotation of the drum 6.
On claim 6, Larsen cites:
The module according to claim 2, wherein the module is configured to be attached the an (objection) actuation button of the medical injection device or a dosage selector of the medical injection device.
[0030] FIG. 1 shows the proximal end of an injection device comprising a combined dose setting and injection button 1, which button is rotated to set a dose and pressed in an axial direction to inject the set dose. The button 1 is fixed to a tubular element 2 so that element 2 will follow as well rotational as axial movements of the button 1.
[0031] When the button 1 is rotated to set a dose the tubular element 2 is rotated too. The tubular element 2 has a flange 3 carrying a number of A-shaped teeth 4 which engages corresponding depressions in an internal circumferential flange 5 in a dose setting drum 6 concentric with the tubular element 2 so that said drum 6 is rotated with said tubular element 2 and the button 1 when said button is rotated to set a dose. When the dose setting drum 6 is rotated it will, due to a not shown thread connection between said drum 6 and a not shown housing concentrically surrounding said dose setting drum 6 and said tubular element 2, be screwed outward in said housing and will lift the button 1 up from the end of said housing.
[0032] The button 1 accommodates an electronic unit mounted on a circuit board 15 and comprising a sealed circuit block 10, which is powered by a battery 11 through contacts 12 and 13. From the circuit block 10 output signals are fed through a multi wire cable to a LCD display 14. Further the sealed circuit block 10 has an integrated magnetic sensible component 17 which can give off a signal when it is moved relative to a magnet ring 7 at the upper end of the dose setting drum 6. The magnetic ring 7 is magnetised to have a number of alternating magnetic poles along its perimeter. When the dose-setting drum rotates relative to the button 1 the sensor 17 will give off a signal reflecting the magnetic field sensed by this sensor. The end wall of the button 1 is provided with a window 8 made from a transparent material to allow inspection of the display 14.
[0033] The electronic circuit in the sealed circuit block 10 comprises a timer which is started when a dose is injected and the status of which is shown for a while in the display 14 when the button 1 is pressed by pressing the window 8 so that the electronic unit in the button 1 is moved against the force of a spring 19 whereby a button 20 of a switch 18 is pressed to activate said switch.
On claim 7, Larsen cites:
The module according to claim 2, comprising an attachment unit for releasably attaching the module to the medical injection device.
[0039] Although only magnetic acting signal generators are mentioned the use of other, e.g. optical signal generators and sensors lies within the scope of the invention. Also the button in which the electric components are integrated, although it is described as a fixed part of the device, may be removable so that it can be moved from a possible disposable injection device and mounted on a new one, only the devices must be provided with the necessary signaller to generate signals from the sensors. This may appropriately be obtained by moulding such signallers into the syringes by using a mouldable magnetic plastic material.
On claim 8, Larsen cites:
The module according to claim 7, wherein the attachment unit is adapted to fit on an outer circumference of at least a portion of the medical injection device. See figure 1 and [0039] wherein button 1 slides over the syringe assembly 6.
On claim 10, Larsen cites:
The module according to claim 2, comprising an optical sensor.
[0039] Although only magnetic acting signal generators are mentioned the use of other, e.g. optical signal generators and sensors lies within the scope of the invention.
On claim 11, Larsen cites:
The module according to claim 2, comprising a module housing which is of cylindrical shape.
Figure 1 discloses at least a piston type assembly wherein figure 2 discloses a circular magnetic position device 10 which, when put together with figure 1, discloses a cylindrical assembly.
On claim 12, Larsen cites:
The module according to claim 2, wherein the dose determination unit is connected to the electric unit and wherein the electric unit is further configured to store and/or provide information related to a determined dose of the medicament.
[0043] The operational amplifiers 25 and 26, the AND converters 27 and 28, the normalising circuit and the look up table can all be integrated in the sealed circuit block. The output signal from the table 32 can also internally in the circuit block 10 be stored in a storage from which a likewise integrated driver for the display 14 is driven to make the display shown the latest injected dose.
On claim 13, Larsen cites:
The module according to claim 2, wherein the dose determination unit is configured to determine a dose of the medicament selected before the actuation action is applied.
[0020] To measure the size of an injected dose it is necessary to measure the extent of the rotation of the magnet ring relative to the button accommodating the sealed circuit block. This is obtained by using a number of Hall elements positioned along an arc of a circle which follows a section of said magnet ring. At the start of the rotation the relative position of the magnet ring relative to Hall elements is defined by the magnetic field which is detected by the Hall elements.
On claim 14, Larsen cites:
The module according to claim 2, wherein the information related to the detected actuation action is a representation of a time instant at which the actuation action is detected, or a representation of a time duration that has passed since the actuation action was detected, or information indicating whether a pre-defined time duration since the actuation action was detected has already passed.
[0014] The sealed electronic circuit block may comprise a timer
which may have a first input for a reset signal, a second input for a signal activating a read out of the timer, and an output to a display displaying the read out of the time lapsed after the latest receipt of a signal on said first input, the injection device further being provided with a sensor connected to the first input of said timer, which sensor gives off a signal when the injection button is pressed to move the piston rod.
On claim 17, Larsen cites:
The module according to claim 2, comprising
a detector unit,
[0036] When the button 1 is pressed the activation of the switch 18 will provide a signal which directly or indirectly triggers the circuit block 10 to activate the display 14 for a while to show the status of the timer.
the detector unit comprising the switch,
[0032] The button 1 accommodates an electronic unit mounted on a circuit board 15 and comprising a sealed circuit block 10, which is powered by a battery 11 through contacts 12 and 13.
the electric unit, a battery, and a module housing,
figure 1, button 1 (which acts as the housing for the disclosed elements)
wherein the actuation action is exerted via the detector unit and is detected by the switch.
[0014] The sealed electronic circuit block may comprise a timer
which may have a first input for a reset signal, a second input for a signal activating a read out of the timer, and an output to a display displaying the read out of the time lapsed after the latest receipt of a signal on said first input, the injection device further being provided with a sensor connected to the first input of said timer, which sensor gives off a signal when the injection button is pressed to move the piston rod.
On claim 18, Larsen cites:
A system comprising a medical injection device comprising an actuation button and a module configured for attachment to the medical injection device, the module comprising:
a switch configured to detect an actuation action of the medical injection device, the medical injection device being configured such that the actuation action causes at least a portion of a medicament contained in the medical injection device to be ejected from the medical injection device;
an electric unit connected to the switch and configured to store and/or provide information related to the detected actuation action; and
a dose determination unit configured to detect a rotational movement of a dose dial sleeve of the medical injection device during a dose injection.
See the rejection of claim 2 which discloses the same subject matter as claim 18 and is rejected for the same reasons.
On claim 19, Larsen cites:
The system according to claim 18, wherein the medical injection device comprises a dosage selector configured to be turned to select a medicament dose to be ejected by the medical injection device.
[0031] When the button 1 is rotated to set a dose the tubular element 2 is rotated too. The tubular element 2 has a flange 3 carrying a number of A-shaped teeth 4 which engages corresponding depressions in an internal circumferential flange 5 in a dose setting drum 6 concentric with the tubular element 2 so that said drum 6 is rotated with said tubular element 2 and the button 1 when said button is rotated to set a dose. When the dose setting drum 6 is rotated it will, due to a not shown thread connection between said drum 6 and a not shown housing concentrically surrounding said dose setting drum 6 and said tubular element 2, be screwed outward in said housing and will lift the button 1 up from the end of said housing.
On claim 21, Larsen cites:
The system according to claim 18, wherein the medical injection device comprises a medicament container configured to contain a cartridge of the medicament.
[0003] cartridge
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 3-5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen et al., U.S. 2002/0143288 (see IDS).
On claim 3, Larsen cites except as underlined:
The module of claim 2, wherein the electric unit comprises an electric circuit formed
[0006] The electronic circuit may be a common commercial circuit or an integrated circuit block which is designed and manufactured specifically to be used in the device in question. Once such an integrated circuit block has left the production line as a functioning circuit it is very reliable, and failing of the device is mainly due to the wiring and connections to sensors outside the circuit. Especially sensors based on mechanical contacts are rather sensible to wear, dust and oxidation.
on a printed circuit board having one or more layers of wiring.
Regarding the excepted claim limitations, Larsen, as disclosed above, includes using integrated circuits for its embodiment. Larsen doesn’t disclose using printed circuits for its embodiment. However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to substitute the cited integrated circuit with a printed circuit such that the claimed invention is realized. Printed circuits are well known in the art of electronics and one of ordinary skill would have substituted a printed circuit in place of an integrated circuit and the results of the substitution would have predicted the claimed invention. The Examiner submits the use of printed circuits are so well known in the art that an Official Notice is exercised in considering this known art. See MPEP 2144.03.
On claim 4, Larsen cites except as underlined:
The module of claim 3, further comprising a battery, wherein the printed circuit board is arranged between the switch and the battery.
Figure 1 and [0032]
[0032] The button 1 accommodates an electronic unit mounted on a circuit board 15 and comprising a sealed circuit block 10, which is powered by a battery 11 through contacts 12 and 13. From the circuit block 10 output signals are fed through a multi wire cable to a LCD display 14. Further the sealed circuit block 10 has an integrated magnetic sensible component 17 which can give off a signal when it is moved relative to a magnet ring 7 at the upper end of the dose setting drum 6. The magnetic ring 7 is magnetised to have a number of alternating magnetic poles along its perimeter. When the dose-setting drum rotates relative to the button 1 the sensor 17 will give off a signal reflecting the magnetic field sensed by this sensor. The end wall of the button 1 is provided with a window 8 made from a transparent material to allow inspection of the display 14.
As disclosed above, the cited “switch,” that is, contacts 12 and 13 having battery 11 located therebetween. Circuit 13 is located below battery 11 and contacts 12 and 13. The circuit isn’t arranged in the manner claimed.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to include into Larsen a circuit meeting the claimed invention. Unless the positioning of the claimed elements is something new and unexpected and the cited embodiment otherwise functionally operations in the manner as in the claimed invention, merely rearranging the elements isn’t considered patentable subject matter. One of ordinary skill, apprise of this, would have provided an embodiment otherwise meeting the claimed invention.
MPEP 2144.04 C. Rearrangement of Parts
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.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
On claim 5, Larsen cites except as underlined:
The module of claim 3, further comprising an LED, wherein the electric circuit is configured to turn on the LED for a pre-defined time in response to an activation of the switch.
Larsen cites:
[0032] The button 1 accommodates an electronic unit mounted on a circuit board 15 and comprising a sealed circuit block 10, which is powered by a battery 11 through contacts 12 and 13. From the circuit block 10 output signals are fed through a multi wire cable to a LCD display 14. Further the sealed circuit block 10 has an integrated magnetic sensible component 17 which can give off a signal when it is moved relative to a magnet ring 7 at the upper end of the dose setting drum 6. The magnetic ring 7 is magnetised to have a number of alternating magnetic poles along its perimeter. When the dose-setting drum rotates relative to the button 1 the sensor 17 will give off a signal reflecting the magnetic field sensed by this sensor. The end wall of the button 1 is provided with a window 8 made from a transparent material to allow inspection of the display 14.
Larsen cites using an LCD display. Larsen doesn’t disclose using an LED display. However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to substitute an LED display in place of the cited LCD display wherein the modified embodiment provides an embodiment meeting the claimed invention. LEDs are known in the art as a variant of a class of electronic displays and one of ordinary skill, apprised of this knowledge would have substituted the LCD for the LED and the results of the swap would have made the claimed invention obvious. Furthermore, the Examiner submits the use of LEDs are so well known in the art that an Official Notice is exercised in considering this known art. See MPEP 2144.03.
On claim 16, Larsen cites except as underlined:
The module according to claim 2, wherein the switch is an electric switch with an actuator that forms part of or protrudes out of a detector unit in a way that the actuator is moved downwards or inwards when a force is applied to the detector unit as part of the actuation action and wherein the actuator is configured such that the downward or inward motion of the actuator closes the electric switch.
Larsen, [0036] discloses an embodiment wherein in figure 1, button 1, which is part of the mechanical operation which administers medication to a patient. The pressing of button 1 enables switch 18. Switch 18, in turn, turns on a display 14 to indicate the status of the injection. Larsen doesn't disclose if the switch 18 is such that when enabled, a circuit is "closed."
However, it would have been obvious at the time the claimed invention was filed to include the features of a "closed switch" to the cited switch 18. Clearly, display 14 is reacting to the switch 18 being acted upon as a result of a user depressing button 1. Although the operation doesn't specifically disclose a closure of an "electrical switch," the cooperation of the cited elements in Larsen clearly suggest somewhere in the operation, a circuit is completed, causing the display to carry out its function. One of ordinary skill in the art would have included a known switch being "closed" to cause the display to function.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen et al., U.S. 2002/0143288 in view of Mault et al, U.S. 2003/0208113 (see IDS).
On claim 15, Larsen cites except as underlined:
The module according to claim 2, wherein the electric unit comprises a provision unit configured to provide information by transmission to an electronic device that is different from the medical injection device.
Larsen, [0015], discloses using memory as applied to the disclosed monitored syringe device, which is used to store data in the form of look up tables as shown in [0043].
Larsen doesn't disclose transmitting this information in accordance with the excepted claim limitations.
In the similar art of insulin pumps, Mault, discloses
[0076] The PDA 10 is in communication with the insulin pump 16, using a wireless communications protocol such as Bluetooth, cable, or through human intervention. The PDA receives data on the time and quantity of insulin injections.
It would have been obvious at the time the claimed invention was filed to modify
the features disclosed in Larsen to use the PDA as disclosed in Larsen such that the
claimed invention is realized.
Mault discloses a known application of using a PDA to obtain data from a medical device. One of ordinary skill in the art would have included this feature to allow for easy storage and retrieval of medical data without the use of a wired cabling system.
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen et al., U.S. 2002/0143288 in view of Watanabe et al., WO 2009/125582.
On claim 9, Larsen cites except as underlined:
The module according to claim 7, wherein the attachment unit comprises a plurality of arms or clips configured to engage with or at least partially embrace the medical injection device.
As disclosed in Larsen:
Figure 1 and [0039] discloses: Although only magnetic acting signal generators are mentioned the use of other, e.g. optical signal generators and sensors lies within the scope of the invention. Also the button in which the electric components are integrated, although it is described as a fixed part of the device, may be removable so that it can be moved from a possible disposable injection device and mounted on a new one, only the devices must be provided with the necessary signaller to generate signals from the sensors. This may appropriately be obtained by moulding such signallers into the syringes by using a mouldable magnetic plastic material.
Larson doesn’t specifically disclose the cited button 1 being coupled to the syringe body 6 using clips or arms. In the same art of syringes, Watanabe discloses:
Figure 4 and DESCRIPTION OF SYMBOLS 11 Drug administration apparatus 12 Housing | casing 13 Tip cap 13a Confirmation window 13b Opening part 14 Syringe cover 14a Detachment protrusion 14b Syringe contact inclination part 14c Puncture needle mounting part 14d Housing 14e Detection protrusion 14f Syringe mounting claw 14g Arm spring 14h Syringe Mounting arm 14i Support shaft 14j Stopper 15 Preparation syringe 15a, 15b Seal rubber 15c Syringe cover contact inclined part 15d ID (identification piece)
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention such that the mounting claw of 14f disclosed in Watanabe is incorporated into the button 1 of Larsen such that the button 1 is affixed the cited syringe body 6. One of ordinary skill would have included this feature as a way to ensure the button 1 doesn’t separate for the syringe body 6.
Allowable Subject Matter
Claim 20 is objected to for depending on rejected claim 19 but would be otherwise allowable if amended into the independent claim. Claim 20 claims, in part:
“wherein the dosage selector is configured for rotation relative to the housing during a dose dialing and configured not to rotate relative to the housing during the dose injection,
wherein the module is attached to the dosage selector, wherein during the dose dialing, no rotational movement of the dosage selector is made relative to the dose dial sleeve, and during the dose injection, the dose dial sleeve rotates relative to the dosage selector, and
wherein a relative rotational movement between the dose dial sleeve and the dosage selector is detected during the dose injection.”
This embodiment is directed to a syringe “piggyback” device removably coupled to a syringe, the device used to provide the user with a means to pre-measure medicament of the syringe though a dial dosage selector. Referring to figure 1 and 2, a caregiver rotates dosage knob 12 to attain a desired amount of medicament to be dispensed through syringe 1 to a receiving patient. Upon selection of the desired dosage, the caregiver depresses button 2, the actuation causing not only the pre-determined medicament to be dispensed to the patient, but any concurrent data being recorded and displayed using the electrical circuit disclosed in figure 3. Returning to figure 1, as the medicament is dispensed, a numerically marked sleeve rotates and is displayed through dosage window 13, the sleeve indicating the amount of medicament being expended concurrent to the caregiver’s application to the button 2. The distinguishing feature of this syringe is the rotating sleeve 13 changing with respect to the caregiver’s continued depressing of the syringe.
The closest reference of record is the present reference to Larsen, U.S. 2002/0143288, which discloses:
[0043] The operational amplifiers 25 and 26, the AND converters 27 and 28, the normalising circuit and the look up table can all be integrated in the sealed circuit block. The output signal from the table 32 can also internally in the circuit block 10 be stored in a storage from which a likewise integrated driver for the display 14 is driven to make the display shown the latest injected dose.
In other words, as the medicament is dispensed in Larsen, display 14 shows the dosage dispensed to the patient. The display 14, unlike the rotating sleeve 13 of the invention, is a digital display. The rotating sleeve of the invention is mechanical. A search for similar embodiments disclosing the claimed invention did not yield satisfactory results. Accordingly, claim 20 is allowable subject matter.
Response to Arguments
The applicant’s arguments regarding the rejection of claim 2 has been carefully reviewed. The applicant’s argument asserts:
“Without conceding the merits of the rejections, Applicant has amended independent claims 2 and 18 to expedite prosecution. Applicant respectfully submits that, for example, Larsen, Mault, and Watanabe, taken alone or in combination, fail to disclose or suggest at least, (i) "[a] module for attachment to a medical injection device that comprises an actuation button, [and] a dose dial sleeve of the medical injection," as recited in amended claim 2. Larsen does not teach both the claimed "actuation button" included in a "medical injection device," and the claimed "dose dial sleeve of the medical injection device."
Larsen discloses:
[0030] FIG. 1 shows the proximal end of an injection device comprising a combined dose setting and injection button 1, which button is rotated to set a dose and pressed in an axial direction to inject the set dose. The button 1 is fixed to a tubular element 2 so that element 2 will follow as well rotational as axial movements of the button 1.
[0031] When the button 1 is rotated to set a dose the tubular element 2 is rotated too. The tubular element 2 has a flange 3 carrying a number of A-shaped teeth 4 which engages corresponding depressions in an internal circumferential flange 5 in a dose setting drum 6 concentric with the tubular element 2 so that said drum 6 is rotated with said tubular element 2 and the button 1 when said button is rotated to set a dose. When the dose setting drum 6 is rotated it will, due to a not shown thread connection between said drum 6 and a not shown housing concentrically surrounding said dose setting drum 6 and said tubular element 2, be screwed outward in said housing and will lift the button 1 up from the end of said housing.
Thus, the evidence clearly shows Larsen discloses the above claim limitations the applicant alleges are not cited in Larsen. For this reason, the applicant’s argument is unpersuasive. For the same reasons articulated in item 23, arguments regarding the rejection of claim 2 also apply to the arguments regarding the rejection of claims 6-8, 10-14, 17-19, and 21 also apply.
Conclusion
THIS ACTION IS MADE FINAL. 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 CAL EUSTAQUIO whose telephone number is (571)270-7229. The examiner can normally be reached on 8am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Brian Zimmerman, can be reached at (571) 272-3059. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application lnformation Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAlR only. For more information about the PAlR system, see http:/lpair-direct.uspto.gov. Should you have questions on access to the Private PAlR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-91 99 (IN USA OR CANADA) or 571-272-1000.
/CAL J EUSTAQUIO/Examiner, Art Unit 2686
/BRIAN A ZIMMERMAN/Supervisory Patent Examiner, Art Unit 2686
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