DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/6/26 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, 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 negated by the manner in which the invention was made.
Claim 1, 3-5, 7-11, 18-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harms et al. (US 2009/0275916 A1) in view of Slate et al. (US 2011/0224616 A1).
With regard to claim 1, Harms discloses An injection device (fig. 1a) for injecting of a dose of a medicament, the injection device comprising: a housing (1 generally, specifically 2 and 3) to accommodate at least a cartridge (6) filled with the medicament ([0115]) and a drive mechanism (17), wherein the housing comprises comprising a single-pieced distal housing portion (2 is a single piece all together) having a distally facing distal end face (see at 8 where the distal end of the 2 wraps around a distal end face of the cartridge) to make contact with a skin of a patient, the drive mechanism arranged inside the housing (see Fig. 1a) and comprising: a piston rod (17) configured to engage with a piston (7) of the cartridge and operable to displace the piston in a distal direction during and for injection of the dose of the medicament, the distal end face of the single-pieced distal housing portion encircling an axis of displacement of the piston (see Fig. 1a, 2 encircles the axis of displacement of the piston); and an actuation member (49 for example but other structures could be considered the actuation member without further claim limitations defining the actuation member) operable to induce or trigger a distally directed displacement of the piston rod when actuated by a user of the injection device ([0128]); and a control ([0073], can be a mechanical dose control or an electrical dosing mechanism) held by the housing ([0073]).
However, Harms does not disclose the control registering contact with a skin of the patient.
Slate teaches a similar autoinjector type device (Fig. 6) having a housing (214), wherein the housing comprises a distally facing distal end face (260, at 258) and an electrical skin contact sensor (262) disposed at the distal end face (at 258, see Fig. 6, [0075], [0019]) of the housing and configured to provide an electrical skin contact signal when the distal end face makes contact with the skin (262 measures the capacitance between the sensor and the skin, thereby qualifying as an electrical skin contact [0075]); and a control (218) to register a contact of the distal dispensing end face with the skin of the patient based on the electrical skin contact signal from the electrical skin touch sensor ([0075]) and to impede a distally directed displacement of the piston rod in the absence of the contact between the distal dispensing end face and the skin of the patient ([0019], [0075], microcomputer will operate a duty cycle for the system only whne such contact is indicated, otherwise there can be no operation of the system). Thus the skin sensor of Slate can be added to the distal end face of the single-pieced distal housing portion of Harms in order to detect when the skin has been contacted.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 3, Harms discloses the claimed invention except for the skin touch sensor.
Slate teaches wherein the electrical skin touch sensor (262) is connected to the control and wherein the control is operable to release a dose injection only in response to a detection of a skin contact ([0019], [0075]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 4, Harms discloses the control but does not disclose it being operable to release a dose injecting actuation only if the skin contact has been detected.
Slate teaches a medicament delivery device (Fig. 6) that further includes a skin sensor (262) that works with a controller (218) to register a contact of the injection device with a skin of a patient and to impede a distally directed displacement of the piston rod in the absence of a contact between the injection device and the skin of the patient ([0019], [0075]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 5, Harms discloses wherein the control comprises an electronic control module ([0073]).
With regard to claim 7, Harms discloses further comprising an indicator operable to provide at least one of a visual indication, an audible indication, or a tactile indication to a user of the injection device (audible and tactile, [0137]).
With regard to claim 8, Harms discloses wherein the indicator is implemented as one of a visual indicator operable to generate the visual indication, an acoustic indicator operable to generate the audible indication, or a tactile indicator operable to generate the tactile indication ([0137])
With regard to claim 9, Harms discloses wherein the control is operable to trigger at least one of the visual indication, the audible indication, or the tactile indication to the user of the injection device [0137]).
With regard to claim 10, Harms discloses wherein the control is operable to visually, audibly, or tactilely instruct a user to correctly operate or to correctly handle the injection device. ([0137]).
With regard to claim 11, Harms discloses wherein the control is coupled to the indicator ([0013], [0018]).
However, Harms does not disclose the contact of the skin.
Slate teaches a medicament delivery device (Fig. 6) that further includes an electrical skin sensor (262) that works with a controller (218) to register a contact of the injection device with a skin of a patient and to impede a distally directed displacement of the piston rod in the absence of a contact between the injection device and the skin of the patient ([0019], [0075]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 18, Harms discloses wherein the control ([0073]) is operable to store or to record an initial use of injection device and to calculate a particular date after which the injection device should no longer be used ([0073], use of the term “operable” indicates functional language and the prior art is only required to teach the structure of the control and does not need to explicitly teach the function recited as long as the control would be capable of performing the recited function).
With regard to claim 19, Harms discloses further comprising the cartridge filled with the medicament and arranged inside the housing ([0115]).
With regard to claim 20, Harms discloses wherein the control is configured to automatically reset in response to an insertion of a new cartridge into the housing ([0005], [0150], [0152]).
Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harms et al. (US 2009/0275916 A1) in view of Slate et al. (US 2011/0224616 A1) in view of Bode et al. (US 2013/0012885 A1).
With regard to claim 6, Harms/Slate teach the claimed invention except for a timer circuit.
Bode teaches a similar injection device that further includes a timer circuit embedded in the electronic control module and operable to deactivate and/or to obstruct the drive mechanism for a predefined period of time ([0016]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms/Slate to include a timer circuit as taught by Bode for the purpose of allowing a health care professional to monitor and control a patient’s use of the device to follow a tailored treatment regime ([0016]).
Claim 12-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harms et al. (US 2009/0275916 A1) in view of Slate et al. (US 2011/0224616 A1) in view of Podaima (US 2009/0043253 A1).
With regard to claim 12 and 13, Harms/Slate teach the claimed invention except for a visual indicator.
Podaima teaches a similar injection device that further includes a visual indicator in the form of a LED of different colors ([0138]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms/Slate to include a visual indicator as taught by Podaima for the purpose of assisting a user to understand the different states the injection device is in, whether it is locked or unlocked ([0138]).
Claim 14-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harms et al. (US 2009/0275916 A1) in view of Atterbury et al. (US 2004/0210199A1).
With regard to claim 14, Harms discloses the claimed invention except for a power supply.
Atterbury teaches wherein the drive mechanism comprises a power supply including a battery ([0149]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms with a battery as taught by Atterbury for the purpose of powering the control ([0149]).
With regard to claim 15, Harms discloses the claimed invention except for the status of the battery.
Atterbury teaches wherein the control is operable to monitor the status of the battery ([0150]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms with a battery as taught by Atterbury for the purpose of powering the control ([0149]).
With regard to claim 16, Harms discloses the claimed invention except for the battery.
Atterbury teaches wherein the control is further operable to interlock the drive mechanism if a power provided by the battery drops below a predefined threshold ([0149], [0150], use of the term “operable” indicates functional language and the prior art is only required to teach the structure of the control and does not need to explicitly teach the function recited as long as the control would be capable of performing the recited function).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms with a battery as taught by Atterbury for the purpose of powering the control ([0149]).
With regard to claim 17, Harms discloses the claimed invention except for a battery
Atterbury teaches wehrein the control is operable to indicate to the user that a change of the battery is due when a power provided by the battery drops below a predefined threshold ([0149], [0150], use of the term “operable” indicates functional language and the prior art is only required to teach the structure of the control and does not need to explicitly teach the function recited as long as the control would be capable of performing the recited function).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Harms with a battery as taught by Atterbury for the purpose of powering the control ([0149]).
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Claim 1, 3-5, 7-11, 14-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atterbury et al. (US 2004/0210199A1) in view of Slate et al. (US 2011/0224616 A1).
With regard to claim 1, Atterbury discloses An injection device (fig. 2) for injecting of a dose of a medicament, the injection device comprising: a housing (26) to accommodate at least a cartridge (22) filled with the medicament ([0079]) and a drive mechanism (120), the drive mechanism arranged inside the housing and comprising: a piston rod (120) configured to engage with a piston (34) of the cartridge and operable to displace the piston in a distal direction during and for injection of the dose of the medicament; and an actuation member (30) operable to induce or trigger a distally directed displacement of the piston rod when actuated by a user of the injection device; and a control ([0148], [0192], [0196], microprocessor).
However, Atterbury does not disclose the control registering contact with a skin of the patient.
Slate teaches a similar autoinjector type device (Fig. 6) having a housing (214), wherein the housing comprises a distally facing distal end face (260, at 258) and an electrical skin contact sensor (262) disposed at the distal end face (at 258, see Fig. 6, [0075], [0019]) of the housing and configured to provide an electrical skin contact signal when the distal end face makes contact with the skin (262 measures the capacitance between the sensor and the skin, thereby qualifying as an electrical skin contact [0075]); and a control (218) to register a contact of the distal dispensing end face with the skin of the patient based on the electrical skin contact signal from the electrical skin touch sensor ([0075]) and to impede a distally directed displacement of the piston rod in the absence of the contact between the distal dispensing end face and the skin of the patient ([0019], [0075], microcomputer will operate a duty cycle for the system only whne such contact is indicated, otherwise there can be no operation of the system).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Atterbury to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 3, Atterbury discloses the claimed invention except for the skin touch sensor.
Slate teaches wherein the electrical skin touch sensor (262) is connected to the control and wherein the control is operable to release a dose injection only in response to a detection of a skin contact ([0019], [0075]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Atterbury to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 4, Atterbury discloses the control but does not disclose it being operable to release a dose injecting actuation only if the skin contact has been detected.
Slate teaches a medicament delivery device (Fig. 6) that further includes a skin sensor (262) that works with a controller (218) to register a contact of the injection device with a skin of a patient and to impede a distally directed displacement of the piston rod in the absence of a contact between the injection device and the skin of the patient ([0019], [0075]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Atterbury to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 5, Atterbury discloses wherein the control comprises an electronic control module ([0148], [0192], [0196], microprocessor).
With regard to claim 7, Atterbury discloses further comprising an indicator operable to provide at least one of a visual indication, an audible indication, or a tactile indication to a user of the injection device (audible indication, [0018], [0013]).
With regard to claim 8, Atterbury discloses wherein the indicator is implemented as one of a visual indicator operable to generate the visual indication, an acoustic indicator operable to generate the audible indication, or a tactile indicator operable to generate the tactile indication (audible, [0013], [0018]).
With regard to claim 9, Atterbury discloses wherein the control is operable to trigger at least one of the visual indication, the audible indication, or the tactile indication to the user of the injection device ([0013], [0018], audible indication is triggered by the control when the device is delivering medication the audible clicking sound is also initiated).
With regard to claim 10, Atterbury discloses wherein the control is operable to visually, audibly, or tactilely instruct a user to correctly operate or to correctly handle the injection device. ([0013], [0018], the audible clicking allows a user to understand the injection process and therefore contributes to instructing a user to correctly operate or handle the device).
With regard to claim 11, Atterbury discloses wherein the control is coupled to the indicator ([0013], [0018]).
However, Atterbury does not disclose the contact of the skin.
Slate teaches a medicament delivery device (Fig. 6) that further includes an electrical skin sensor (262) that works with a controller (218) to register a contact of the injection device with a skin of a patient and to impede a distally directed displacement of the piston rod in the absence of a contact between the injection device and the skin of the patient ([0019], [0075]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Atterbury to include a skin sensor as taught by Slate for the purpose of allowing the user to ascertain whether the system has been properly positioned for an injection and prevent operation is the system is not properly positioned ([0019]).
With regard to claim 14, Atterbury discloses wherein the drive mechanism comprises a power supply including a battery ([0149]).
With regard to claim 15, Atterbury discloses wherein the control is operable to monitor the status of the battery ([0150]).
With regard to claim 16, Atterbury discloses wherein the control is further operable to interlock the drive mechanism if a power provided by the battery drops below a predefined threshold ([0149], [0150], use of the term “operable” indicates functional language and the prior art is only required to teach the structure of the control and does not need to explicitly teach the function recited as long as the control would be capable of performing the recited function).
With regard to claim 17, Atterbury discloses wherein the control is operable to indicate to the user that a change of the battery is due when a power provided by the battery drops below a predefined threshold ([0149], [0150], use of the term “operable” indicates functional language and the prior art is only required to teach the structure of the control and does not need to explicitly teach the function recited as long as the control would be capable of performing the recited function).
With regard to claim 18, Atterbury discloses wherein the control is operable to store or to record an initial use of the injection device and to calculate a particular date after which the injection device should no longer be used ([0195], use of the term “operable” indicates functional language and the prior art is only required to teach the structure of the control and does not need to explicitly teach the function recited as long as the control would be capable of performing the recited function).
With regard to claim 19, Atterbury discloses further comprising the cartridge filled with the medicament and arranged inside the housing ([0079]).
With regard to claim 20, Atterbury discloses wherein the control is configured to automatically reset in response to an insertion of a new cartridge into the housing ([0024], [0092]-[0096]).
Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atterbury et al. (US 2004/0210199A1) in view of Slate et al. (US 2011/0224616 A1) in view of Bode et al. (US 2013/0012885 A1).
With regard to claim 6, Atterbury/Slate teach the claimed invention except for a timer circuit.
Bode teaches a similar injection device that further includes a timer circuit embedded in the electronic control module and operable to deactivate and/or to obstruct the drive mechanism for a predefined period of time ([0016]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Atterbury/Slate to include a timer circuit as taught by Bode for the purpose of allowing a health care professional to monitor and control a patient’s use of the device to follow a tailored treatment regime ([0016]).
Claim 12-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atterbury et al. (US 2004/0210199A1) in view of Slate et al. (US 2011/0224616 A1) in view of Podaima (US 2009/0043253 A1).
With regard to claim 12 and 13, Atterbury/Slate teach the claimed invention except for a visual indicator.
Podaima teaches a similar injection device that further includes a visual indicator in the form of a LED of different colors ([0138]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Atterbury/Slate to include a visual indicator as taught by Podaima for the purpose of assisting a user to understand the different states the injection device is in, whether it is locked or unlocked ([0138]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783