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) 16-18, 20-21, 23-27, 29-30, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey et al. (US 2016/0015445) in view of Zubry (US 2006/0030816), and further in view of Piehl et al. (US 2015/0025500).
Regarding claim 16, Hoey et al. (henceforth Hoey) discloses a vapor generator (e.g., 304, Figure 3; ¶ [0057]) including a generator body (designated generally as generator 304) for receiving fluid from a fluid source (see e.g., fluid source 414 in Figure 4). Hoey fails to explicitly disclose the syringe assembly including the magnetic components as the fluid source and the ability of the device to perform a refill via rearward movement of the plunger.
Zubry teaches a syringe fluid delivery source comprising a barrel defining an opening, a plunger, wherein the plunger includes a first magnet of the plunger (24, ¶ [0027] the piston is itself magnetic and moves via interaction with external magnet assembly 28) which cooperates with a second magnet (28) of a controller (¶ [0027]), wherein upon advancement of the shaft toward the opening via interaction between the first magnet and the second magnet, fluid moves from the barrel, through the opening, and upon retraction of the shaft away from the opening via interaction between the first magnet and the second magnet, the plunger moves rearwardly (the magnetic plunger 24 can be moved along the barrel of the cartridge 22 in either direction as it is coupled with external magnet 28; see line 30 in figure 1 which depicts movement in both directions along the cartridge).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vapor generator of Hoey to utilize the magnetic plunger fluid source of Zubry to provide a means of delivering fluid from the source without the need for a plunger rod thereby reducing the overall size of the device and providing means of inserting cartridges of various lengths while retaining the utility of fluid delivery as taught by Zubry (¶¶ [0028] and [0030]-[0031]).
Hoey/Zubry fail to teach the ability of the device to refill the syringe via rearward movement of the plunger.
Piehl et al. (henceforth Piehl) teaches (Figure 1) an infusion system which comprises a fluid outlet (26) having a first one-way valve (20) and a fluid inlet (22) having a second one-way valve (18) which is configured to deliver fluid through the outlet during a procedure and to refill the barrel (12) during rearward movement of the plunger (30a) from the fluid inlet (e.g., ¶ [0019] discloses filling the barrel via rearward movement of the plunger from fluid source 24 and ¶ [0020] discloses the delivery of the fluid through valve 20).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the fluid source assembly of Hoey to comprise the delivery and refill means of Piehl to allow for automatic refilling of the device between injections as taught by Piehl while allowing fluid flow into and out of the source via fluidly separate pathways to allow for delivery and refill of the source during a procedure as taught by Piehl.
Regarding claim 17, Hoey further discloses wherein upon advancement of the shaft, fluid flows into a vapor delivery device (¶ [0057], fluid flows from the source into vapor delivery device 300 and out along vapor delivery needle 302).
Regarding claim 18, Hoey/Zubry further teach the vapor generator is configured to advance the shaft to prime the vapor delivery device and, after priming the vapor delivery device, before delivering vapor to a patient, automatically retract the shaft to refill the barrel (the combined device of Hoey/Zubry is designed for movement of the plunger of the cartridge in either direction as desired as in ¶ [0046]; in this manner, the device is considered fully capable of performing a priming step before retraction and filling the barrel as claimed; the vapor generator is not a structure which is being interpreted as performing any specific method steps (as one would a processor or controller of the vapor generator) and the combined device of the prior art is fully capable of performing these functions as claimed).
Regarding claims 20 and 29, Zubry further teaches wherein the vapor generator is configured to automatically retract or advance the shaft to refill the syringe without operator intervention (see ¶ [0052] of Zubry which discloses use of the system with a controlled automated dispensing system; because Zubry discloses bi-directional movement of the magnetic drive system, it would be fully capable of automatic retraction or advancement to and point along the cartridge when controlled by an automated system as disclosed). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the automated delivery system of Zubry to allow automatic control over plunger movement during a procedure as taught by Zubry (it is noted that the limitation is not being given the weight of a method step as it is set forth in a device claim and there are no programmable structures claimed for requiring explicit disclosure of the method steps).
Regarding claims 21 and 30, Zubry further teaches wherein the vapor generator is configured to automatically retract or advance the shaft after reaching a specific point of delivery such as the end of the barrel or for performing a priming step (see ¶ [0052] of Zubry which discloses use of the system with a controlled automated dispensing system; because Zubry discloses bi-directional movement of the magnetic drive system, it would be fully capable of automatic retraction or advancement to and point along the cartridge when controlled by an automated system as disclosed). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the automated delivery system of Zubry to allow automatic control over plunger movement during a procedure as taught by Zubry (it is noted that the limitation is not being given the weight of a method step as it is set forth in a device claim and there are no programmable structures claimed for requiring explicit disclosure of the method steps).
Regarding claim 23, Piehl further teaches a first valve (18) coupled to the opening (via 14), wherein the first valve allows fluid to flow into the barrel and restricts fluid from flowing out of the barrel (it’s a one way valve that only allows fluid flow from source 24 into the barrel as per ¶ [0015]; see above for the modification of claim 16).
Regarding claim 24, Piehl further teaches a second valve (20) fluidly coupled to the opening (via 14), wherein the second valve allows fluid to flow out of the barrel and restricts fluid from flowing into the barrel (it’s a one way valve that only allows fluid flow out of the fluid source and blocks fluid flow back through the valve as per ¶ [0015]; see above for the modification of claim 16).
Regarding claim 25, Hoey discloses a vapor generator (e.g., 304, Figure 3; ¶ [0057]) including a generator body (designated generally as generator 304) for receiving fluid from a fluid source (see e.g., fluid source 414 in Figure 4). Hoey fails to explicitly disclose the syringe assembly including the magnetic components as the fluid source and the valve structures for controlling fluid flow.
Zubry teaches a syringe fluid delivery source comprising a barrel defining an opening, a plunger, wherein the plunger includes a first magnet of the plunger (24, ¶ [0027] the piston is itself magnetic and moves via interaction with external magnet assembly 28) which cooperates with a second magnet (28) of a controller (¶ [0027]), wherein upon advancement of the shaft toward the opening via interaction between the first magnet and the second magnet, fluid moves from the barrel, through the opening, and upon retraction of the shaft away from the opening via interaction between the first magnet and the second magnet, the plunger moves rearwardly (the magnetic plunger 24 can be moved along the barrel of the cartridge 22 in either direction as it is coupled with external magnet 28; see line 30 in figure 1 which depicts movement in both directions along the cartridge).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vapor generator of Hoey to utilize the magnetic plunger fluid source of Zubry to provide a means of delivering fluid from the source without the need for a plunger rod thereby reducing the overall size of the device and providing means of inserting cartridges of various lengths while retaining the utility of fluid delivery as taught by Zubry (¶¶ [0028] and [0030]-[0031]).
Hoey/Zubry fail to teach the ability of the device to refill the syringe via rearward movement of the plunger.
Piehl et al. (henceforth Piehl) teaches (Figure 1) an infusion system which comprises a fluid outlet (26) having a first one-way valve (20) and a fluid inlet (22) having a second one-way valve (18) which is configured to deliver fluid through the outlet during a procedure and to refill the barrel (12) during rearward movement of the plunger (30a) from the fluid inlet (e.g., ¶ [0019] discloses filling the barrel via rearward movement of the plunger from fluid source 24 and ¶ [0020] discloses the delivery of the fluid through valve 20).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the fluid source assembly of Hoey to comprise the delivery and refill means of Piehl to allow for automatic refilling of the device between injections as taught by Piehl while allowing fluid flow into and out of the source via fluidly separate pathways to allow for delivery and refill of the source during a procedure as taught by Piehl.
Regarding claim 26, Hoey/Zubry/Piehl further teach wherein the fluid flows into a vapor delivery device (302, 308; Figure 3 of Hoey).
Regarding claims 27 and 35, Zubry further teaches wherein the vapor generator is configured to automatically retract or advance the shaft to prime or refill the syringe without operator intervention (see ¶ [0052] of Zubry which discloses use of the system with a controlled automated dispensing system; because Zubry discloses bi-directional movement of the magnetic drive system, it would be fully capable of automatic retraction or advancement to and point along the cartridge when controlled by an automated system as disclosed in order to prime, refill, or deliver as desired). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the automated delivery system of Zubry to allow automatic control over plunger movement during a procedure as taught by Zubry (it is noted that the limitation is not being given the weight of a method step as it is set forth in a device claim and there are no programmable structures claimed for requiring explicit disclosure of the method steps).
Regarding claims 32-34, Hoey discloses a vapor generator (e.g., 304, Figure 3; ¶ [0057]) including a generator body (designated generally as generator 304) for receiving fluid from a fluid source (see e.g., fluid source 414 in Figure 4) for delivery to the prostate of a patient (¶ [0056]). Hoey fails to explicitly disclose the syringe assembly including the magnetic components as the fluid source as well as the ability to refill the device via retraction of the shaft.
Zubry teaches a syringe fluid delivery source comprising a barrel defining an opening, a plunger, wherein the plunger includes a first magnet of the plunger (24, ¶ [0027] the piston is itself magnetic and moves via interaction with external magnet assembly 28) which cooperates with a second magnet (28) of a controller (¶ [0027]), wherein upon advancement of the shaft toward the opening via interaction between the first magnet and the second magnet, fluid moves from the barrel, through the opening, and upon retraction of the shaft away from the opening via interaction between the first magnet and the second magnet, the plunger moves rearwardly (the magnetic plunger 24 can be moved along the barrel of the cartridge 22 in either direction as it is coupled with external magnet 28; see line 30 in figure 1 which depicts movement in both directions along the cartridge).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vapor generator of Hoey to utilize the magnetic plunger fluid source of Zubry to provide a means of delivering fluid from the source without the need for a plunger rod thereby reducing the overall size of the device and providing means of inserting cartridges of various lengths while retaining the utility of fluid delivery as taught by Zubry (¶¶ [0028] and [0030]-[0031]).
Hoey/Zubry fail to teach the ability of the device to refill the syringe via rearward movement of the plunger.
Piehl et al. (henceforth Piehl) teaches (Figure 1) an infusion system which comprises a fluid outlet (26) having a first one-way valve (20) and a fluid inlet (22) having a second one-way valve (18) which is configured to deliver fluid through the outlet during a procedure and to refill the barrel (12) during rearward movement of the plunger (30a) from the fluid inlet (e.g., ¶ [0019] discloses filling the barrel via rearward movement of the plunger from fluid source 24 and ¶ [0020] discloses the delivery of the fluid through valve 20).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the fluid source assembly of Hoey to comprise the delivery and refill means of Piehl to allow for automatic refilling of the device between injections as taught by Piehl while allowing fluid flow into and out of the source via fluidly separate pathways to allow for delivery and refill of the source during a procedure as taught by Piehl.
Claim(s) 19 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Zubry in view of Piehl, and further in view of Hochman (US 7,449,008).
Regarding claims 19 and 28, Hoey/Zubry/Piehl teach the claimed invention substantially as set forth above for claim 17, but fail to explicitly disclose measuring a pressure against a pressure threshold.
Hochman teaches (Figure 3) a medical injection device which utilizes pressure sensors to measure an infusion pressure so as to not exceed a desired limit or threshold (e.g., Col. 4, lines 58-64 and Col. 7, lines 1-8 which disclose using the sensors and preventing the device from exceeding a desired pressure limit as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Hoey/Zubry/Piehl to comprise the pressure measurement system of Hochman so as to prevent injury from excessive injection pressure during a procedure via prevention the device from exceeding a pre-set pressure threshold as taught by Hochman.
Claim(s) 22 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Zubry in view of Piehl, and further in view of Villegas (US 2009/0088732).
Regarding claims 22 and 31, Hoey/Zubry/Piehl teach the claimed invention substantially as set forth above for claim 16, but fail to explicitly disclose the user interface and refill button.
Villegas teaches a drug infusion system comprising a user interface (700, Figure 7) comprising a button (726) for performing a refill procedure (¶ [0043]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Hoey/Zubry/Piehl to comprise the user interface and associated system buttons for the purpose of providing a user the ability to read information regarding the system during a procedure, and for performing desired system steps during a procedure, such as refilling the fluid source, as taught by Villegas.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783