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) 1, 2, 4-7, 10, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke et al. (US 2010/0152653) in view of Hoke et al. (US 2008/0221507).
Regarding claim 1, Hoke et al. (henceforth Hoke ‘653) discloses (Figure 1) a nasal irrigator, comprising a nasal irrigator body (16), a nasal irrigator handle (cartridge 40, Figures 3 and 4), a clean water tank (12), and a dirty water tank (14), wherein the clean water tank and the dirty water tank are arranged on a side of the nasal irrigator body (Figure 1), and a water inlet pump communicated with the clean water tank and a dirty water pump (120; ¶ [0033]) communicated with the dirty water tank are provided inside the nasal irrigator body (Figure 5); and the nasal irrigator body is provided with an insertion hole configured to fix the nasal irrigator handle (formed as top housing 84 and bottom housing portion formed as upper connecting portion of controller 16 as seen in Figure 1; it is noted that the handle is disclosed as more of a cartridge than a holdable assembly as seen in Figure 2, wherein the “handle” 20 extends into an opening in the top housing portion 101), and the nasal irrigator handle is allowed to be inserted into the insertion hole or taken out of the insertion hole (¶ [0034] discloses insertion and removal of cartridge 40 into the body of controller 16); and a water inlet soft rubber nozzle and a water return soft rubber nozzle (nasal pillows 90) are mounted on the nasal irrigator handle (Figures 1 and 4; the pillows 90 are mounted on seats 48 and 58 of the handle 40; ¶ [0034]), the water inlet soft rubber nozzle is communicated with the water inlet (supply port inlet 42 connects to irrigation outlet nozzle 48 through conduit 46; ¶ [0034]), and the water return soft rubber nozzle is communicated with the dirty water pump (effluent port outlet 52 is connected to nozzle 58 through conduit 56; ¶ [0034]). Hoke ‘653 fails to explicitly disclose a pump assembly for the clean water tank.
Hoke et al. (henceforth Hoke ‘507) teaches (Figure 9) a nasal irrigator assembly (100) which utilizes a positive pressure pump in addition to a negative pressure pump to drive fluid into one nostril and remove fluid from the other nostril during a procedure (¶ [0046]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the irrigation assembly of Hoke ‘653 to comprise the positive pressure clean solution pump of Hoke ‘507 so as to allow the supply and waste tanks to be mounted below the top cover of the device while providing means for maintaining the use of the device via a positive pump rather than through gravity as taught by Hoke ‘507 (¶ [0046]).
Regarding claim 2, Hoke ‘653 further discloses (Figures 1 and 5) wherein the nasal irrigator handle (40) comprises an upper handle cover (50) and a lower handle cover (60) buckled together with each other (¶ [0035]; they’re secured together to form the device body). Hoke ‘653 discloses that the clean water inlet (42) and waste water outlet (52) are clamped between the upper and lower handle covers (Figure 2; ¶ [0034]), but fails to explicitly disclose the nozzle portions as being clamped (they extend through the upper handle portion as in Figure 4). There is no evidence of record that establishes that changing the connection means of the nozzle receiving portions 48 and 58 would result in a difference in function of the irrigation device. Further, a person having ordinary skill in the art, being faced with modifying the irrigation system of Hoke ‘653, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed connection means (as it is already disclosed for a portion of the same conduits). Lastly, applicant has not disclosed that the claimed securement means solves any stated problem, indicating simply that “a tail end of the water inlet soft rubber nozzle 201 and a tail end of the water return soft rubber nozzle 202 are fixedly clamped between the upper handle cover 203 and the lower handle cover 204), and therefore there appears to be no criticality placed on the connection means as claimed such that it produces an unexpected result (it is set forth only as the connection means and no statement of unexpected results or novelty related to the fixation means is provided). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the upper and lower housing portions of Hoke ‘653 to clamp both ends of the conduits between the housing portions, including the soft nozzles 90, as an obvious matter of design choice within the skill of the art.
Regarding claim 4, Hoke ‘653 further discloses wherein a handle cover (upper housing portion 84 and upper portion of body 16 which receive the cartridge 40 therein) is provided at the insertion hole of the nasal irrigator body, and the nasal irrigator handle is inserted into the handle cover (Figure 1); and a guide plate is fixedly arranged on a side of the handle cover and is located between the handle cover and the water inlet pump and the dirty water pump arranged side by side (guide plate 62 fixes the cartridge within the body of 16; ¶ [0034]; in the cited combination the pumps are located within the body 16 and may be considered side by side as claimed).
Regarding claim 5, Hoke ‘653 further discloses wherein a first water inlet pipe (46) is connected to the water inlet soft rubber nozzle (48), and the water inlet soft rubber nozzle is communicated with the water inlet pump through the first water inlet pipe (¶ [0034]; and a first water outlet pipe (56) is connected to the water return soft rubber nozzle (58), and the water return soft rubber nozzle is communicated with the dirty water pump through the first water outlet pipe (¶ [0034]).
Regarding claim 6, Hoke ‘653 and Hoke ‘507 further teach wherein a second water inlet pipe is connected to the clean water tank (the male supply inlet port 42 is inserted into supply receiver outlet as per ¶ [0034]; the supply receiver outlet is the second inlet pipe), and the clean water tank (12) is communicated with the water inlet pump through the second water inlet pipe (Figure 1; ¶ [0034]; in the cited combination, the water inlet would be connected to the pump outlet to drive the fluid through the system and out the irrigation nozzle); and a second water outlet pipe (effluent receiver inlet port receives male effluent port 52 as per ¶ [0034]; the effluent receiver port is considered the second water outlet pipe) is connected to the dirty water tank, and the dirty water tank is communicated with the dirty water pump through the second water outlet pipe (e.g., ¶ [0033] discloses the vacuum pump, attached to the effluent receiver bottle 14 draws vacuum through receiver 20 which, in turn, pulls fluid through the effluent return lines into the waste receiver bottle).
Regarding claim 7, Hoke ‘653 further discloses wherein a fixed frame is fixedly arranged in the nasal irrigator body, a limiting hole is formed in the fixed frame in a penetrating manner, and the first water inlet pipe and the first water outlet pipe pass through the limiting hole (see annotated figure below; the fixed frame is formed in housing 16 as a receiving area for the connection ends of the pipes with the respective fluid inlet and outlet sources).
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Regarding claim 10, Hoke ‘653/Hoke ‘507 further teach wherein the clean water tank (12) comprises an upper clean water tank cover (upper portion of reservoir 12) and a lower water tank cover (bottom portion of reservoir 12) buckled with the upper clean water tank cover (they’re integral and are therefore connected), and the lower clean water tank cover is provided with a first accommodating cavity (chamber of 12) to accommodate clean water (¶ [0030]; saline is considered analogous to “clean water” as that is what is used in the instant invention).
Regarding claim 15, Hoke ‘653 further discloses wherein a top cover (84, Figure 1) is provided at a top of the nasal irrigator body, a bottom cover (80) is provided at a bottom of the nasal irrigator body (Figure 1), and a battery box (recess for containing battery 92) configured to accommodate a battery (92) is provided on the bottom cover (¶ [0036]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke ‘653 in view of Hoke ‘507, and further in view of Doerr et al. (US 2017/0119939).
Regarding claim 3, Hoke ‘653 and Hoke ‘507 disclose the claimed invention substantially as set forth above for claim 2, but fail to place a PCB in the handle cover with a control button.
Doerr et al. (henceforth Doerr) teaches (Figures 12A-12B) a powered irrigation device (110) which incorporates a PCB (the electrical circuit disclosed in ¶ [0082] is considered analogous) into the handle and provides a button (e.g., irrigation button 113) to control a pump (120).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the handle assembly of Hoke ‘653 to include an electrical contact and switch assembly therein so as to provide a means of actuating the pumps within the handle body during use as taught by Doerr. Moving the actuation means of Hoke ‘653 into the cartridge (handle) assembly would allow the power button to be placed adjacent the nozzle rather than on a side of the device as originally disclosed by Hoke ‘653.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke ‘653 in view of Hoke ‘507, and further in view of Siposs (US 4,758,224).
Regarding claim 9, Hoke ‘653/Hoke ‘507 teach the claimed invention substantially as set forth above for claim 5, but fail to explicitly disclose the one-way valve on the water inlet pipe.
Siposs teaches (Figures 2-3) a one way valve (umbrella valve 62) which is connected to a fluid line (Figure 2) at a junction (it forms a three-way connection as depicted in Figure 2) and allows for the injection of air into the fluid pathway (Col. 3, line 62-Col. 4, line 3).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the fluid pathway of Hoke ‘653/Hoke ‘507 to include the one way valve of Siposs to allow for a means of controlling the infusion pressure through the device during a procedure by the automatic actuation of a one way valve which opens to admit air if a negative pressure exceeds a desired value as taught by Siposs.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke ‘653 in view of Hoke ‘507 and further in view of Groth (US 4,558,484).
Regarding claim 14, Hoke ‘653/Hoke ‘507 teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose the water tanks arranged vertically in a notch of the device.
Groth teaches (Figures 1-2) a device comprising a clean water tank (48) and a dirty water tank (50) which are vertically stacked (Figure 2) and reside within a notch in the device for retaining both tanks therein (see Figure 3, the tanks are frictionally held within a notch or opening in the housing 30 during use; see also Col. 8, lines 3-13).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the tanks of Hoke ‘653/Hoke ‘507 to comprise the vertically stacked tank structure of Groth since Groth teaches that such a means is known in the art for stacking clean and dirty tank assemblies for access and removal within a device body. Such a modification allows a user the ability to remove the tanks while keeping them close within the body of the device during use which can prevent unwanted removal or use of the device when the reservoirs are not properly secured.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke ‘653 in view of Hoke ‘507, and further in view of Naglreiter (US 2022/0323096).
Regarding claim 16, Hoke ‘653/Hoke ‘507 disclose the claimed invention substantially as set forth above for claim 1, and Hoke ‘653 further discloses a controller, within the body, connected to the pump (pump operation is driven by a switch in the handle as per ¶ [0038]). However, they fail to disclose all of the utility functions of claim 16 such as the power supply, data processing, pump control, Bluetooth, and touch detection as claimed.
Naglreiter teaches a medical device fluid flow system which utilizes a controller module (118) for controlling the device which comprises a power supply circuit (in power module 120), a data processing circuit (in data storage module 124), a pump control circuit (for controlling pump 114), a Bluetooth chip circuit (¶ [0043] discloses the controller using wireless data transfer over Bluetooth), and a touch detection circuit (the device comprises a touch screen capability as per ¶ [0043]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the nasal irrigator of Hoke ‘653/Hoke ‘507 to comprise the controller and associated modules of Naglreiter to provide a number of additional functions to the irrigator device as taught by Naglreiter. Such a modification would allow for the basic use of pump control and power, while allowing for data monitoring of pump operation, and the linking of the device to a computer or phone for tracking use metrics, as well as allowing for touch operation of the device in the manner taught by Naglreiter.
Regarding claim 17, Naglreiter further teaches wherein the control circuit further comprises an antenna circuit (the Wi-Fi or Bluetooth modules may be considered to comprise antennae for data transmission) electrically connected to the data processing circuit and the touch detection circuit (¶ [0063] discloses that the controller board 418 comprises all of the previously disclosed modules which would place the antenna circuit in connection with the claimed modules).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoke ‘653 in view of Hoke ‘507 in view of Naglreiter, and further in view of Rodriguez et al. (US 2019/0336757).
Regarding claim 18, Hoke ‘653/Hoke ‘507/Naglreiter teach the claimed invention substantially as set forth above for claim 16, but fail to explicitly disclose two power supply circuits for 5V and 3.3V.
Rodriguez et al. (henceforth Rodriguez) teaches a medical device which utilizes a PCB for distributing 3.3V to most of the board components while also stepping up to 5V for specific component requirements (¶ [0252]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the control system of Hoke/Naglreiter to provide a variable voltage means such as that taught by Rodriguez so as to allow the board to provide the desired amount of power to each component as required and as taught by Rodriguez.
Allowable Subject Matter
Claims 8 and 11-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: the prior art made of record and relied upon does not anticipate or render obvious, alone or in combination, the features of the cited claims. The closest prior art is considered to be Hoke ‘653 which discloses a nasal irrigation device comprising a cartridge for housing nozzles and associated fluid lines for insertion into the pump body. Claim 8 requires a silicone case for fixing the inlet and outlet pumps which also comprises an accommodating cavity for receiving “drooping” portions of the first water inlet pipe and the first water outlet pipe. Hoke ‘653 fails to disclose any type of tubing management or pump receptacle, and while cases and bags for carrying pumping apparatus are known in the art, there would be no reasonable motivation to place such a mechanism within the device housing in the claimed manner. The prior art fails to reasonably teach such a feature for suction/irrigation systems and it would be allowable for at least this reason. Regarding claim 11, Hoke ‘653 fails to teach the use of an upper tank cover with a second accommodating cavity for receiving a saline pack and the use of spikes for puncturing the saline pack on a through hole as claimed. The prior art teaches the use of a fillable reservoir, and while there are systems which utilize pierceable saline bags as claimed, it would not have been obvious to one of ordinary skill in the art to utilize a saline bag in addition to clean water within an irrigation fluid tank as claimed. Claims 12-13 would be allowable due to their dependence from claim 11. For at least these reasons, the claims are considered allowable over the prior art made of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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