DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the limitation “the single-piece housing having a distally facing distal end face to make contact with a skin of a patient”. It does not appear there is support for this claim limitation was added after the initial disclosure. It appears the distal end of 16 is considered the distal end face but does not appear that the specification describes this face as actually contacting the skin of a patient. [0137] indicates this end is connected with a needle for delivering the medication and thus this distal end face does not directly the contact the skin of the patient itself. This is similar to that of the Harms reference being used to reject the claims. It is requested Applicant point to support for this claim limitation. Thus the distal end face of the housing is considered to be capable of being touched against the skin but there is no actual support that it directly touches the skin surface and further such that when contact is made the electrical skin touch sensor provides an electrical skin contact signal.
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) and in further view of Engaard (US 2002/0120235 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 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 (this face of the housing would be capable of coming into contact with a skin of the patient as this is a functional limitaiton, also see 112 rejection above for interpretation), 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]).
However, Harms/Slate do not teach the housing is a single-pieced housing.
Engaard teaches a similar autoinjector type device showing a housing (Fig. 1a, element 10 as a single piece comprising the portions 11, 12 and 20 that are all formed from a single material. These portions correspond to similar housing elements of Harms including the proximal portion (11) being similar to the proximal housing of Harms and element 12 being similar to that of the distal cartridge holder housing of Harms. Engaard teaches that these proximal and distal components can be made separate and then connected via a known method such as threaded or bayonet ([0043], this is similar to how the housing of Harms is structured) or that the housing a can be a single piece as shown in the figures. Thus the concept of having two housing components or a single housing component as being interchangeable and well-known in the art.
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 alternatively be a single piece housing as taught by Engaard because the substitution of a two piece housing vs a single piece housing is well-known in the art and does not affect the overall function of the device ([0043]).
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 Engaard (US 2002/0120235 A1) and Bode et al. (US 2013/0012885 A1).
With regard to claim 6, Harms/Slate/Engaard 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/Engaard 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 Engaard (US 2002/0120235 A1) and Podaima (US 2009/0043253 A1).
With regard to claim 12 and 13, Harms/Slate/Engaard 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/Engaard 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 Slate et al. (US 2011/0224616 A1) and in further view of Engaard (US 2002/0120235 A1) and Atterbury et al. (US 2004/0210199A1).
With regard to claim 14, Harms/Slate/Engaard 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/Slate/Engaard with a battery as taught by Atterbury for the purpose of powering the control ([0149]).
With regard to claim 15, Harms/Slate/Engaard 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/Slate/Engaard 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/Slate/Engaard 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/Slate/Engaard with a battery as taught by Atterbury for the purpose of powering the control ([0149]).
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.
Applicant states that Harms does not teach the single-piece housing and points to Fig. 3 of the present invention as support for a single piece housing. However, in this Figure the housing is two pieces a proximal piece 12 and a distal housing 16 for holding the cartridge. It appears the only support for a single-piece housing is in [0043] that mentions the two piece housing could be considered to be made a single piece. It does not appear the figures or any other description describe the single-piece housing. Thus it is considered a well-known substitute as provided in the present invention. Thus Engaard is being taught to teach the single-piece housing. Second, Applicant states that the distal end face of Harms doesn’t contact the skin surface. However, the claims, read in light of the specification, appear to teach a similar structure as that taught by Harms. With a distal end face that is then connected with a needle for delivery. Thus the distal end face of Harms is considered to teach the distal end face of the claims. Also see the 112(a) rejection indicating the lack of support for the distal end face to actual contact the skin of the patient. Clarification or support is needed to overcome the current rejection.
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 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
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