DETAILED ACTION
Response to Amendment
The amendment filed May 12, 2026 has been entered. Claims 16, 21, 23-25, and 32 have been amended. Claims 33-34 have been cancelled, and claims 36-37 are newly added. Claims 16-32 and 35-37 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 37 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The scope of claim 37, as currently drafted, cannot be reasonably determined. It’s is unclear how the shaft is being limited. For the purposes of examination, the claim will be interpreted as if the shaft is inserted into the barrel lumen as it’s the only lumen set forth.
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, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson et al. (US 2013/0123888) in view of Duchon et al. (US 2002/0022807).
Regarding claims 16, 25, and 32, Samson et al. (henceforth Samson) discloses a vapor generator (e.g., 300, Figure 3; ¶ [0049]) comprising a syringe (Figure 3) including: a barrel (Figure 3) defining a distal opening (for needle 314), a proximal opening (for receiving plunger 308), and a lumen between the proximal opening and the distal opening (forming the reservoir and receiving plunger 308); and a plunger (distal end surface of shaft 308) within the lumen (Figure 3; fluid receiving portion of body and through to needle 314); a generator body (designated generally as body of 300) for receiving fluid from a fluid source (see e.g., reservoir 112/312; ¶ [0049]) including a shaft (shaft of plunger rod 308), wherein the shaft extends through the proximal opening into the lumen (it can be seen in Figure 3 that the plunger 308 extends from outside the body through into the reservoir formed by the lumen); wherein upon advancement of the shaft toward the distal opening, via interaction between the plunger and shaft, fluid moves from the barrel through the distal opening (e.g., ¶ [0050]); and wherein, upon retraction of the shaft away from the distal opening via interaction of the plunger and shaft, fluid moves from a fluid reservoir, through the distal opening, and into the barrel to refill the syringe (in a fluid-tight system, with the plunger at the distal end, an aspiration force can be generated via distal movement of the plunger which is fully capable of drawing fluid into the barrel of the syringe if desired; see ¶ [0050] which discloses that the device may be operated as a standard piston or plunger rod delivery device). Samson fails to disclose the magnetic coupling of the shaft and the plunger via first and second magnets).
Duchon et al. (henceforth Duchon) teaches a syringe fluid delivery source comprising a barrel (750; Figure 25) defining an opening (for receiving plunger shaft 754), a plunger (618, 752; ¶ [0223]), wherein the plunger includes a first magnet of the plunger (756, ¶ [0223]) which cooperates with a second magnet (758) of a shaft (754; ¶ [0027]; it is noted that the second magnet of the plunger is located within the barrel to engage the plunger as required by claim 32), 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 linkage of 758 and 756 allows the piston to be moved distally and proximally along the barrel of 750 as long as the magnetic coupling force is not exceeded; this linkage between the plunger and shaft forms the magnetic attraction coupling of claim 25).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vapor generator of Samson to utilize the magnetic plunger coupling means of Douchon to provide a means of connecting the plunger to a piston in the barrel via reduced engagement force which can be easily obtained by selecting magnets with the desired disengagement force as taught by Douchon (¶ [0224]).
Regarding claims 17 and 26, Samson further discloses wherein upon advancement of the shaft, fluid flows into a vapor delivery device (e.g., through needle 314 which may be considered a vapor delivery device as it provides a path for the vapor to exit the device).
Regarding claims 18, 27, and 35, Samson further discloses that 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 device of Samson is designed for movement of the plunger in either direction as desired; 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, Samson further discloses wherein the vapor generator is configured to automatically retract or advance the shaft to refill the syringe without operator intervention (see ¶ [0057] of Samson which discloses use of the system with a controlled automated dispensing system (e.g., Samson discloses that any system parameters, such as flow rate, can be increased or decreased as desired based upon sensed signals from the system during a procedure; this would include adjusting the plunger rod to control the flow rate out of the device); because Samson discloses automatic movement of the plunger assembly, 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 Samson to allow automatic control over plunger movement during a procedure as taught by Samson (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, Samson 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 ¶ [0057] of Samson which discloses use of the system with a controlled automated dispensing system (e.g., Samson discloses that any system parameters, such as flow rate, can be increased or decreased as desired based upon sensed signals from the system during a procedure; this would include adjusting the plunger rod to control the flow rate out of the device). 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 Samson to allow automatic control over plunger movement during a procedure as taught by Samson (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 37, Samson discloses wherein the shaft is inserted into a lumen of the barrel (see Figure 3).
Claim(s) 19 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Duchon, and further in view of Hochman (US 7,449,008).
Regarding claims 19 and 28, Samson/Duchon 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 Samson/Duchon 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 Samson in view of Duchon, and further in view of Villegas (US 2009/0088732).
Regarding claims 22 and 31, Samson/Duchon 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 Samson/Duchon 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.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Duchon, and further in view of Piehl et al. (US 2015/0025500).
Regarding claims 23 and 24, Samson/Duchon teach the claimed invention substantially as set forth above for claims 16 and 23, and Samson further discloses a first valve fluidly coupled to the distal opening, wherein the first valve allows fluid to flow out of the barrel and restricts fluid from flowing into the barrel (see ¶ [0050] of Samson which discloses moving the plunger to open a valve at the distal end to allow the vapor to exit the device). Samson/Duchon fail to explicitly disclose the use of a second valve for restricting fluid to flow into the barrel and preventing fluid from flowing out of the barrel as claimed in claim 23.
Piehl et al. (henceforth Piehl) teaches (Figure 1) an infusion system which comprises a fluid outlet (26) having a first one-way valve (18) and a fluid inlet (22) having a second one-way valve (20) 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).
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).
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 Samson/Duchon 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) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samson in view of Duchon, and further in view of Rolla (US 2005/0137532).
Regarding claim 36, Samson/Duchon teach the claimed invention substantially as set forth above for claim 36, but fail to explicitly disclose a third magnet. Though it is noted that Samson discloses a handle (manual plunger rod with second magnet on distal end) coupled to the plunger having a first magnet as set forth above for claim 16. Applicant appears to be claiming a sub-combination wherein the system can be used with a handle to manually fill the syringe prior to inserting the syringe into the generation. Therefore, it is noted that the disclosure only supports two attached magnets for coupling the plunger to either a manual handle or the shaft of a generator for automatic control. It is noted that Samson teaches either manual or automatic pumping means for control of the plunger as set forth above.
Rolla teaches a syringe device (Figure 1) comprising a plunger (4) which is designed to be attached to both manual and automatic drive systems (¶¶ [0069]-[0070]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the vapor generator system of Samson/Duchon to be used in manual or automatic systems since Rolla teaches that it is useful to provide automatic dosing, mixing, or dispensing, while retaining the ability to use the syringe in a traditional manual delivery mode. In such a combination, the magnetic linkage of Samson/Duchon would provide a means of attaching any driving rod to the piston with the low engagement force taught by Duchon which would provide the utility of coupling the plunger to various drive systems as desired.
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 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
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