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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5, 6, 14, 15, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2015/0190588 to Hanson et al. (“Hanson”) in view of U.S. Patent Publication No. 2016/0346485 to MOHR et al. (“Mohr”) and U.S. Patent Publication No. 2014/0350513 to Oruklu et al. (“Oruklu”).
Regarding claim 1, Hanson teaches a drug delivery device (Figs. 1A-1C) comprising a housing (16), a reservoir (50) positioned within the housing and configured to receive a fluid, a fluid line (30) in fluid communication with the reservoir, a delivery sub-system ([0054], compression springs of drive mechanism 100, [0054]) configured to deliver a fluid from the reservoir to the fluid line, an insertion mechanism (200) comprising a cannula (214, Figs. 4A-4B) in fluid communication with the fluid line, the insertion mechanism configured to move the cannula from a retracted position, where the cannula is positioned within the housing to an extended position where at least a portion of the cannula is positioned outside of the housing ([0063], first position and second position), a pressure sensor configured to detect a pressure within the fluid line ([0064], pressure sensors are used to monitor pressure in the fluid pathway, i.e., the fluid line), control electronics (power and control system 400) configured to actuate the insertion mechanism based on a signal from the pressure sensor ([0064]), and a hydrophobic membrane (233, Fig. 5A) in fluid communication with the fluid line (30), the fluid line extends between the delivery sub-system and the insertion mechanism (Fig. 1B), the hydrophobic membrane configured to allow air to be expelled from the fluid line ([0062]), but does not explicitly teach the claimed position of the membrane, and the claimed position of the pressure sensor relative to the membrane although both the pressure sensor and the membrane are taught by Hanson and does not explicitly mention the use of a pressure drop as an indication of air, although pressure measurements are used by Hanson to indicate the expulsion of air.
Mohr teaches a hydrophobic membrane (100, Fig. 1, also [0006]) positioned along a fluid line (130) and a sensor (182, Fig. 1) positioned downstream of the hydrophobic membrane. Regarding the hydrophobic membrane, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the membrane of Hanson along the fluid line as taught by Mohr to yield the predictable result of providing a means of gas elimination to enhance patient treatment. Both Hanson and Mohr teach a membrane, Mohr merely shows an alternative position to accomplish the same result. Once combined, the hydrophobic membrane would be positioned between the delivery sub-system and the insertion mechanism.
Additionally or in the alternative, it would have been obvious to one having ordinary skill in the art at the time the invention was made to position the membrane on the fluid line between the delivery sub-system and the insertion mechanism instead of the present position, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed relative positions would not perform differently than the prior art device (MPEP 2143.04(VI)(C)).
Regarding the sensor, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the sensor of Hanson downstream of the hydrophobic membrane as taught by Mohr for the expected result of determining the elimination rate for a gas elimination apparatus ([0028]).
Oruklu teaches determining a presence of air (386, Fig. 12) by evaluating a pressure drop (384) when fluid is pumped in the fluid line and comparing the pressure drop with a threshold value (Air_Thr?), and wherein the pressure drop is determined based on data from the sensor ([0092], Y(k)). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the manner of determining the presence of air in Hanson and Mohr with the use of a pressure drop to determine the presence of air as taught by Oruklu, because the use of a pressure drop to determine the presence of air is an obvious art-recognized alternative determining means yielding the predictable result of determining the presence of air in a medicament delivery system. Once combined the control electronics would determine the pressure drop within the fluid line (since the Mohr teaches the sensor 182 being on the fluid line 130 in Fig. 1) and between the delivery sub-system and the cannula (since Hanson teaches the fluid line 30 is between the delivery sub-system 100 and cannula 202, [0062]).
Regarding claim 5, Hanson, Mohr, and Oruklu teach the drug delivery device of claim 1 as shown above, Hanson further teaching the control electronics comprises a microcontroller ([0043]).
Regarding claim 6, Hanson, Mohr, and Oruklu teach the drug delivery device of claim 1 as shown above, Hanson further teaching the cannula comprises a needle (214) and a catheter (234, Fig. 6E), the insertion mechanism configured to place the catheter into a patient via the needle (cannula 234 is the equivalent of a catheter as it is inserted by the needle as shown in Figs. 6D-6E).
Regarding claim 14, Hanson, Mohr, and Oruklu teach the drug delivery device of claim 1 as shown above, Hanson further teaching a power source ([0043]).
Regarding claim 15, Hanson, Mohr, and Oruklu teach a method of utilizing the drug delivery device of claim 1 as shown above, Hanson further teaching the method comprising actuating the drug delivery device ([0063], the drug pump is activated), delivering fluid from the reservoir to the fluid line ([0063] and Fig. 6B, the drug pump passes through the conduit), determining whether air is present within the fluid line ([0064], gaseous fluid), sending a signal to the control electronics when air is removed from the fluid line to a predetermined acceptable limit and automatically actuating the insertion mechanism to move the cannula from the retracted position to the extended position ([0063]-[0064], movement from the first to second position is done once the air is removed).
Regarding claim 21, Hanson, Mohr, and Oruklu teach the drug delivery device of claim 1 as shown above, once modified by Mohr, the pressure sensor would be positioned (on fluid conduit 30 of Hanson Fig. 3A) closer to the insertion mechanism (202) than the delivery sub-system (the pressure sensor would be positioned on 30, which is adjacent the insertion mechanism 202 and much closer than the drive components of 100, left portion of 100 in Fig. 100 adjacent reservoir 50 in Hanson).
Regarding claim 22, Hanson, Mohr, and Oruklu teach the drug delivery device of claim 1 as shown above, once fluid conduit 30 of Hanson is modified by the membrane and sensor configuration of Mohr, the pressure sensor is positioned closer to a distal end of the fluid line than a proximal end of the fluid line (given that the sensor is now downstream from the membrane, both of which would be spaced along the fluid conduit).
Additionally or in the alternative, it would have been obvious to one having ordinary skill in the art at the time the invention was made to position the pressure sensor closer to a distal end of a fluid line than a proximal end of the fluid line, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed relative positions would not perform differently than the prior art device (MPEP 2143.04(VI)(C)).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson in view of Mohr and Oruklu as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2009/0149830 to Spector.
Regarding claim 12, Hanson, Mohr, and Oruklu teach the drug delivery device of claim 1 as shown above, but do not teach the solenoid.
Spector teaches an insertion mechanism (48/50, Fig. 2) comprising a solenoid actuator ([0032]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the insertion mechanism of Hanson with a solenoid actuator as taught by Spector, because the solenoid actuator is an art-recognized alternative insertion mechanism yielding the expected result of providing linear force for needle insertion to a desired depth ([0032]) in an analogous drug delivery device.
Regarding claim 13, Hanson, Mohr, and Oruklu teach the drug delivery device of claim 1 as shown above, but do not teach the piezoelectric actuator.
Spector teaches an insertion mechanism (48/50, Fig. 2) comprising a piezoelectric actuator ([0032]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the insertion mechanism of Hanson with a piezoelectric actuator as taught by Spector, because the piezoelectric actuator is an art-recognized alternative insertion mechanism yielding the expected result of providing linear force for needle insertion to a desired depth ([0032]) in an analogous drug delivery device.
Response to Arguments
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the same prior art references as shown above in response to Applicant’s amendments.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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