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 § 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) 15, 16, 18, 19, 22-27, 29, 33, 35, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel (US 5,509,905), Michel (US 5,383,865), Jorgensen et al. (US 2011/0270214 A1), Chen et al. (US 2014/0276583 A1), and Packman et al. (US 6,585,698).
With regard to claims 15, 19, 35, and 36, Michel teaches a supplemental device for attachment to an injection device, the supplemental device comprising: a housing comprising a portion extending therefrom and configured to at least partially surround and removably attach to an exterior portion of the injection device (Fig. 2 housing 32 with portion 26 extending therefrom which at least partially surrounds and removably attached to injection device 28); an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 outer housing); wherein the open state or the closed state of the electromechanical switch arrangement is configured to change when a dose dialled into the attached injection device is decreased from one unit to zero units (Col. 3 lines 3-17, Col. 3 line 58-Col. 4 line 55); and a processor arrangement configured to: detect one or more changes in the open state or the closed state of the electromechanical switch arrangement (Col. 3 lines 45-49); determine from the one or more changes in the open state or the closed state that the dose dialled into the injection device has decreased from one unit to zero units (Col. 3 lines 24-35).
Michel does not show the overall structure of the device or a protrusion as recited. However, Michel ‘865 discloses the supplemental device comprising: a housing comprising a portion extending therefrom and configured to at least partially surround and removably attach to an exterior portion of the injection device (Fig. 2 housing 32 with portion 26 extending therefrom which at least partially surrounds and removably attached to injection device 28); an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 68); and a protrusion configured to protrude from the main body such that the protrusion contacts the exterior portion of the injection device (Fig. 2 protrusion 72 contacts 144 which forms a rear exterior portion of the injection device). A new cartridge 28 may be provided (Col. 1 lines 34-36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a housing and main body structure in Michel as in Michel ’865 as this would be beneficial to allow the cartridge to be replaced and the electronic components reused, this would be an art effective equivalent which would yield the same operation. Michel does not disclose placing the device into a power saving mode. However, Jorgensen et al. teach using a power saving mode when the end of dose is signaled ([0130]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device enter a power saving mode after the dose is delivered in Michel as in Jorgensen et al. as this is beneficial to avoid using power when the device is not in use.
Michel does not disclose in response to determining zero units the processor is configured to trigger communication of data stored in the supplemental device to an external apparatus. However, Chen et al. teach that when the sensor detects a zero-dose position this triggers the controller to transmit dose data ([0006], [0019], [0033]). This allows accurate information to be transmitted and recorded for proper monitoring and dose calculations ([0003]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transmit information after determining the dose has been delivered in Michel as Chen et al. teach this is beneficial for recording accurate information. As such the user input of triggering the dose to be delivered ultimately causes connection to the external apparatus.
Michel does not disclose a processor to determine a type of medicament based on visual recognition of a visible code. However, Packman et al. teach a supplemental device which has a photodetector which senses a color code on a cartridge to determine the medicament preparation to ensure the correct substance is administered and prevent error (Col. 1 lines 40-46, Col. 2 lines 30-39, Col. 7 lines 1-45, Fig. 7, photodetector 190, color code 49). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a photometer and color recognition in Michel as Packman et al. teach this is beneficial to determine the medicament preparation to ensure the correct substance is administered and prevent error. The colored code is visible to the user prior to insertion into the overall injection device and it is visible to the photodetector/processor.
With regard to claim 16, as combined 72 needs to contact the injection device to dial a dose.
With regard to claim 18, as combined above there would necessarily be an amount of time between when the end of dose is detected and when the power save mode begins.
With regard to claim 22, as combined 72 needs to contact the injection device to dial a dose, see protrusion 12 considered as a second protrusion (Fig. 1, Col. 3 lines 24-35).
With regard to claim 23, see Col. 3 lines 45-65, Col. 4 lines 50-55.
With regard to claim 24, Col. 3 line 50-Col. 4 line 55.
With regard to claim 25, the bias of member 165 is used to place 88 in a position such that 72 may be placed against 144 (Fig. 3, Col. 6 lines 25-30, Col. 7 line 56).
With regard to claim 26, member 12 goes into channel 19 which is taken as separate from the surface of the injection device.
With regard to claim 27, turns are counted by means of 17 (Col. 4 lines 4-7).
With regard to claim 35, alternatively member 7 is considered as part of the injection device.
With regard to claim 29, Michel teaches a system comprising: an injection device (not shown cartridge containing substance to be injected); and a supplemental device for attachment to the injection device, the supplemental device comprising: an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 outer housing); wherein the open state or the closed state of the electromechanical switch arrangement is configured to change when a dose dialled into the attached injection device is decreased from one unit to zero units (Col. 3 lines 3-17, Col. 3 line 58-Col. 4 line 55); and a processor arrangement configured to: detect one or more changes in the open state or the closed state of the electromechanical switch arrangement (Col. 3 lines 45-49); determine from the one or more changes in the open state or the closed state that the dose dialled into the injection device has decreased from one unit to zero units (Col. 3 lines 24-35).
Michel does not show the overall structure of the device or a protrusion as recited. However, Michel ‘865 discloses the supplemental device comprising: a housing comprising a portion extending therefrom and configured to at least partially surround and removably attach to an exterior portion of the injection device (Fig. 2 housing 32 with portion 26 extending therefrom which at least partially surrounds and removably attached to injection device 28); an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 68); and a protrusion configured to protrude from the main body such that the protrusion contacts the exterior portion of the injection device (Fig. 2 protrusion 72 contacts 144 which forms a rear exterior portion of the injection device). A new cartridge 28 may be provided (Col. 1 lines 34-36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a housing and main body structure in Michel as in Michel ’865 as this would be beneficial to allow the cartridge to be replaced and the electronic components reused, this would be an art effective equivalent which would yield the same operation. Michel does not disclose placing the device into a power saving mode. However, Jorgensen et al. teach using a power saving mode when the end of dose is signaled ([0130]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device enter a power saving mode after the dose is delivered in Michel as in Jorgensen et al. as this is beneficial to avoid using power when the device is not in use.
Michel does not disclose in response to determining zero units the processor is configured to trigger communication of data stored in the supplemental device to an external apparatus. However, Chen et al. teach that when the sensor detects a zero-dose position this triggers the controller to transmit dose data ([0006], [0019], [0033]). This allows accurate information to be transmitted and recorded for proper monitoring and dose calculations ([0003]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transmit information after determining the dose has been delivered in Michel as Chen et al. teach this is beneficial for recording accurate information. As such the user input of triggering the dose to be delivered ultimately causes connection to the external apparatus.
Michel does not disclose a processor to determine a type of medicament based on an optical property of a visible code. However, Packman et al. teach a supplemental device which has a photodetector which senses a color code on a cartridge to determine the medicament preparation to ensure the correct substance is administered and prevent error (Col. 1 lines 40-46, Col. 2 lines 30-39, Col. 7 lines 1-45, Fig. 7, photodetector 190, color code 49). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a photometer and color recognition in Michel as Packman et al. teach this is beneficial to determine the medicament preparation to ensure the correct substance is administered and prevent error. The colored code is visible to the user prior to insertion into the overall injection device and it is visible to the photodetector/processor.
With regard to claim 33, Michel teaches a supplemental device for attachment to an injection device, the supplemental device comprising: an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 outer housing); wherein the open state or the closed state of the electromechanical switch arrangement is configured to change when a dose dialled into the injection device is decreased from one unit to zero units (Col. 3 lines 3-17, Col. 3 line 58-Col. 4 line 55); a switching member having an open state and a closed state, the switching member comprising a second protrusion configured to contact an additional surface of the injection device only when a dose of zero units is dialled into the injection device (protrusion 12 Fig. 1, Col. 3 lines 24-35); and a processor arrangement configured to: detect one or more changes in the open state or the closed state of the switching member (Col. 3 lines 45-49); determine from the one or more changes in the open state or the closed state that the dose dialled into the injection device has decreased from one unit to zero units (Col. 3 lines 24-35).
Michel does not show the overall structure of the device or a protrusion as recited. However, Michel ‘865 discloses the supplemental device comprising: a housing comprising a portion extending therefrom and configured to at least partially surround and removably attach to an exterior portion of the injection device (Fig. 2 housing 32 with portion 26 extending therefrom which at least partially surrounds and removably attached to injection device 28); an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 68); and a protrusion configured to protrude from the main body such that the protrusion contacts the exterior portion of the injection device (Fig. 2 protrusion 72 contacts 144 which forms a rear exterior portion of the injection device). A new cartridge 28 may be provided (Col. 1 lines 34-36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a housing and main body structure in Michel as in Michel ’865 as this would be beneficial to allow the cartridge to be replaced and the electronic components reused, this would be an art effective equivalent which would yield the same operation.
Michel does not disclose placing the device into a power saving mode. However, Jorgensen et al. teach using a power saving mode when the end of dose is signaled ([0130]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device enter a power saving mode after the dose is delivered in Michel as in Jorgensen et al. as this is beneficial to avoid using power when the device is not in use.
Michel does not disclose in response to determining zero units the processor is configured to trigger communication of data stored in the supplemental device to an external apparatus. However, Chen et al. teach that when the sensor detects a zero-dose position this triggers the controller to transmit dose data ([0006], [0019], [0033]). This allows accurate information to be transmitted and recorded for proper monitoring and dose calculations ([0003]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transmit information after determining the dose has been delivered in Michel as Chen et al. teach this is beneficial for recording accurate information.
Michel does not disclose a photometer or camera, or a processor to determine a type of medicament based on recognition of a color or code of a visible external surface. However, Packman et al. teach a supplemental device which has a photodetector which senses a color code on a cartridge to determine the medicament preparation to ensure the correct substance is administered and prevent error (Col. 1 lines 40-46, Col. 2 lines 30-39, Col. 7 lines 1-45, Fig. 7, photodetector 190, color code 49). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a photometer and color recognition in Michel as Packman et al. teach this is beneficial to determine the medicament preparation to ensure the correct substance is administered and prevent error. The colored code is visible to the user prior to insertion into the overall injection device. It is on an external surface of a component of the injection device and it is visible to the photodetector/processor.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel (US 5,509,905), Michel (US 5,383,865), Jorgensen et al. (US 2011/0270214 A1), Chen et al. (US 2014/0276583 A1), and Packman et al. (US 6,585,698) as applied to claim 27 above, and further in view of Cirillo et al. (US 2012/0065588 A1).
With regard to claim 28, Michel teaches a device substantially as claimed. Michel does not disclose an image capture device and an optical recognition system. However, Cirillo et al. teach a supplemental device (Fig. 1 member 100) wherein the dose dialed detector comprises an image capture device and an optical character recognition system ([0009]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use image capture and optical character recognition in Michel for the purpose of determining the dose of medicament that has already been dialed into the device which is beneficial for preventing overdose ([0005]) and keeping accurate injection records ([0031]).
Allowable Subject Matter
Claims 17, 30-32, and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new interpretation of Michel ‘865 is relied upon. The amendments are sufficient to overcome the previous objections and rejections under 35 U.S.C. 112.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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