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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
Reference character 112 is used to refer to both the nozzle holder and the nozzle seat (Paragraph 0035, 0037-0038)
Reference character 120a is used to refer to both the receiving cavity and the vent hole (Paragraphs 0034, 0039, 0055)
Reference character 120b is used to refer to both the receiving cavity and the vent hole (Paragraphs 0055-0056)
Reference character 130 is used to refer to both the raw liquid tank and the waste liquid tank (Paragraph 0041)
Reference character 1132 is used to refer to the raw liquid port, but is not depicted in the Drawings
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description: 112b. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (US 20090281482 A1, hereinafter “Baker”) in view of Tonomura et al. (JP 2017213281 A, hereinafter “Tonomura”).
Regarding Claim 1, Baker discloses: A dustproof nasal irrigator (Paragraph 0002, The present invention relates generally to the field of medicine, and more specifically to cavity, i.e., nasal aspiration and irrigation, as administered in a medical setting, as well as in the home. In particular, the present devices and methods may be able to aspirate and irrigate simultaneously through one or more nozzles or catheters), comprising:
a nozzle assembly (Paragraph 0107, As can be seen in FIG. 6, the device 2 may include a body 4 removably coupled to a head 14. Both the body 4 and head 14 may be single use, reusable, replaceable, and/or disposable), (Paragraph 0160, The flexible tip 18 (i.e., nozzle or catheter) may be integral with the head 14, or may be a separate removable and/or replaceable and/or disposable component, as shown. The flexible tip 18 is desirably sized and configured to be placed adjacent to, or inserted wholly or partially into, a biological orifice or surface to be irrigated and/or aspirated);
and a cap (Paragraph 0142, A flexible nozzle or catheter or tip 18 may protrude distally from the shell 16, and may include a cap 20 to be positioned on or in or over the flexible tip 18 when the device 2 is not in use, and/or for diagnostic purposes. The cap 20 may include a breakable seal out of the package, and with the first use, the seal is broken. The cap 20 may then be repositioned on or in the flexible tip 18), wherein: the nozzle assembly comprises
a nozzle seat (Figure 12, Paragraph 0107, The head 14 is shown including a shell 16, a flexible tip 18, a cap 20, diagnostic means 22, barrier means 24, an irrigant reservoir 30, and an aspirant reservoir 40),
a raw liquid nozzle and a waste liquid nozzle (Figure 11B, irrigation channel 36, aspiration channel 46), (Paragraph 0088, FIG. 44 is a perspective view of a variation of an irrigation and aspiration device, showing the device including dual nozzles), (Paragraph 0286, Dual tips 194, 195 allow irrigant 32 to be expelled into one nostril while simultaneously or intermittently being aspirated out the other nostril (see FIG. 45)),
the raw liquid nozzle and the waste liquid nozzle are both connected to the nozzle seat (Paragraph 0285, FIG. 44 illustrates that the device 2 can have a head 14 that includes more than one nozzle, i.e., flexible tips, as two flexible tips 194, 195 are shown. Some embodiments may incorporate any and all the features disclosed in the description of the device 2, except some embodiments include the additional feature of dual flexible tips 194, 195);
and the cap is detachably connected to the nozzle seat (Paragraph 0142, A flexible nozzle or catheter or tip 18 may protrude distally from the shell 16, and may include a cap 20 to be positioned on or in or over the flexible tip 18 when the device 2 is not in use, and/or for diagnostic purposes),
Baker describes a removable cap 20 that can be placed over the flexible tip 18 (Paragraph 0142) and serves as a shielding cover. However, the raw liquid nozzle and the waste liquid nozzle are not provided in the shielding cover.
Tonamura more explicitly discloses a shielding cover (Figure 2, covered nozzle 150) wherein:
the shielding cover is detachably connected to the nozzle seat (Paragraph 0023, As shown in Figures 1 and 2(a), the discharge nozzle 20 is formed in a cylindrical (tubular) shape overall, and therefore, the base end portion 22 and the protruding portion 24 are each formed in a cylindrical (tubular) shape. As shown in Figure 1, the base end portion 22 includes a mounting portion 23 that is attached to the oral cavity portion 14), (Paragraph 0018, As shown in Figures 2 to 4, the covered nozzle 150 according to this embodiment is a covered nozzle 150 used by being attached to a storage section 10 that stores cleaning liquid 160, and is configured to include the discharge nozzle 20 described above and the cover section 30 described above),
a receiving cavity is provided in the shielding cover (Paragraph 0036, More specifically, the cover portion 30 has a side circumferential surface portion 31 that is upright relative to the bottom portion 12 of the storage portion 10, and a top surface portion 32. The side circumferential portion 31 is formed in a cylindrical shape, and the top portion 32 is connected to the upper side of the side circumferential portion 31, closing the upper end of the side circumferential portion 31)
and when the shielding cover is connected to the nozzle seat, the raw liquid nozzle and the waste liquid nozzle are both provided in the receiving cavity ((Paragraph 0033, The cover portion 30 is placed over the discharge nozzle 20, thereby making the cover portion 30 detachably attached to the discharge nozzle 20 […] when the cover portion 30 is placed over the discharge nozzle 20, the portion of the base end portion 22 above the stepped portion 27 fits into the lower part of the cover portion 30, thereby attaching the cover portion 30 to the discharge nozzle 20. Furthermore, since the inner diameter of the lower part of the cover portion 30 is the same as the outer diameter of the portion above the stepped portion 27 at the base end portion 22, when the cover portion 30 is attached to the discharge nozzle 20, the inner surface of the lower part of the cover portion 30 is in close contact with the outer surface of the base end portion 22).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Tonamura with the nasal irrigator disclosed by Baker, so as to provide an additional degree of protection from outside contaminants when the device is not in use, as well as a providing comfortable structure when the device is in use (Tonamura, Paragraph 0031, as shown in Figure 8, when the nasal irrigator 100 is placed against the nose with the outlet 21 facing the nasal cavity 202, the outer surface of the cover portion 30 abuts against the area around the nostrils 201 on the nose (and thus the face). Therefore, it is possible to prevent the tip of the discharge nozzle 20 from being inserted too deeply into the nasal cavity 202, and to ensure that the cover portion 30 can be stably in contact with the area around the nostrils 201 on the nose (and thus the face). Furthermore, since the top surface 32 of the cover portion 30 is formed in an upwardly convex curved shape, the feel of the top surface 32 against the area around the nostrils 201 on the nose (and thus the face) becomes softer, thus reducing discomfort when the nasal irrigator 100 is applied to the nose)
Regarding Claim 2, Baker in view of Tomamura discloses all of the limitations of Claim 1. Tomamura further discloses: wherein the nozzle seat is provided with a first clamping portion (Figure 9, positioning ribs 28), the shielding cover is provided with a second clamping portion (Figure 9, positioning recess 36),
and the first clamping portion is clamped with the second clamping portion to connect the shielding cover to the nozzle seat (Paragraph 0036, The positioning recess 36 and the positioning rib 28 are formed in a shape that allows them to fit together. Therefore, by aligning the positioning recess 36 with the positioning rib 28 and placing the cover portion 30 over the discharge nozzle 20, the positioning rib 28 fits into the positioning recess 36).
Regarding Claim 3, Baker in view of Tomamura discloses all of the limitations of Claim 2. Tomamura further discloses: wherein the second clamping portion comprises a clamping groove (Figure 9, positioning recess 36), the first clamping portion comprises a clamping protrusion (Figure 9, positioning ribs 28),
the clamping protrusion is provided in the receiving cavity, and the clamping protrusion is clamped in the clamping groove (Paragraph 0037, The positioning recess 36 is formed in the shape of a groove that extends vertically. On the other hand, positioning ribs 28 extending vertically are formed on the outer surface of the portion of the discharge nozzle 20 above the stepped portion 27 at the base end 22. The positioning recess 36 and the positioning rib 28 are formed in a shape that allows them to fit together. Therefore, by aligning the positioning recess 36 with the positioning rib 28 and placing the cover portion 30 over the discharge nozzle 20, the positioning rib 28 fits into the positioning recess 36)
Tomamura does not disclose the wherein the first clamping portion comprises a clamping groove, the second clamping portion comprises a clamping protrusion, but instead teaches the inverse. However, it would have been obvious to one skilled in the art before the effective filing date to use an alternate connection arrangement, as the functionality of the overall device would be maintained if the groove and protrusion elements swapped positions. Baker also discloses a variety of connection means used in combination in the irrigator device (Paragraph 0139, The head 14 can be removably attached to the body 4 with a (one or more) connector(s) 12. The head 14 may be pressed onto the body 4 until the connectors 12 click the head 14 into place. The connector 12 can be a screw, snap, press fit connector, or combinations thereof, as non-limiting examples).
Regarding Claim 4, Baker in view of Tomamura discloses all of the limitations of Claim 1. Baker further discloses: a raw liquid tank (Figure 6, irrigant reservoir 30); and a waste liquid tank (Figure 6, aspirant reservoir 40), wherein:
the raw liquid tank is communicated with the raw liquid nozzle, the waste liquid tank is communicated with the waste liquid nozzle (Paragraph 0286, Dual tips 194, 195 allow irrigant 32 to be expelled into one nostril while simultaneously or intermittently being aspirated out the other nostril (see FIG. 45)), (Paragraph 0185, The stem 80 (and flexible tip 18) may comprise the irrigation channel 36 and/or the aspiration channel 46),
the raw liquid tank is configured to store the cleaning liquid (Paragraph 0018, the system comprises a head, the head adapted to contain a predetermined amount of irrigation fluid in an irrigation reservoir), (Paragraph 0124, Instructions for use 58 may also be provided to instruct the user on how to use the device 2 and/or the irrigant containers 56 to refill the irrigant reservoir 30 with irrigant 32),
and the waste liquid tank is configured to recover the cleaning liquid (Paragraph 0018, the head containing an aspiration reservoir adapted to contain a predetermined amount of aspired fluid).
Regarding Claim 5, Baker in view of Tomamura discloses all of the limitations of Claim 4. Baker further discloses: a pipeline assembly provided with a raw liquid tube (Figure 16, irrigation channel 36) and a waste liquid tube (Figure 16, aspiration channel 46), wherein:
the nozzle seat is provided with a raw liquid port (Figure 16, irrigation port 34) communicated with the raw liquid nozzle and a waste liquid port (Figure 16, aspiration port 44) communicated with the waste liquid nozzle (Paragraph 0162, The tip 18 can be configured to make a positive seal with the irrigation and/or aspiration site (e.g., the nostril), as seen in FIG. 5B. The distal flexible portion 82 provides the temporary seal with the nostril, allowing for both irrigation (identified with arrow 32) and aspiration (identified with arrow 42) to take place through the respective irrigation channel 36 and aspiration channel 46.),
one end of the raw liquid tube is communicated with the raw liquid tank, another end of the raw liquid tube is communicated with the raw liquid port (Paragraph 0168, As seen in FIG. 19, the irrigant reservoir 30 is shown to be in direct fluid communication with the irrigant port 34, via the irrigation channel 36),
one end of the waste liquid tube is communicated with the waste liquid tank, and another end of the waste liquid tube is communicated with the waste liquid port (Paragraph 0184, In some embodiments, the aspiration reservoir 40 may be in direct fluid communication with the aspiration port 44, via the aspiration channel 46 (see FIG. 19)).
Regarding Claim 9, Baker in view of Tomamura discloses all of the limitations of Claim 1. Baker further discloses: wherein the raw liquid nozzle and/or the waste liquid nozzle (Paragraph 0285, Some embodiments may incorporate any and all the features disclosed in the description of the device 2, except some embodiments include the additional feature of dual flexible tips 194, 195) are detachably connected to the nozzle seat (Paragraph 0160, The flexible tip 18 (i.e., nozzle or catheter) may be integral with the head 14, or may be a separate removable and/or replaceable and/or disposable component, as shown), (Paragraph 0164, The flexible tip 18, and/or all or some of the head 14, i.e., components that may touch the patient, may be removable and/or replaceable and/or disposable).
Regarding Claim 10, Baker in view of Tomamura discloses all of the limitations of Claim 1. Tomamura further discloses: wherein the shielding cover is provided with a vent hole communicated with the receiving cavity (Paragraph 0030, As described above, the cover portion 30 has an opening 33 and a drain port 34. The shape of the opening 33 is not particularly limited, but it can be circular, elliptical, or the like. However, the shape of the opening 33 may be any other shape. In this embodiment, as shown in Figure 4(d), the opening 33 is approximately circular).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 20090281482 A1) in view of Tonomura (JP 2017213281 A), further in view of Layer et al. (US 20190314621 A1, hereinafter “Layer”).
Regarding Claim 6, Baker in view of Tomamura discloses all of the limitations of Claim 5. Baker further discloses: wherein the pipeline assembly further comprises a fixing member (Figure 19, irrigant reservoir port 35),
one end of the fixing member is communicated with the raw liquid tube, another end of the fixing member is communicated with the raw liquid tank, and the raw liquid tube is fixed to the raw liquid tank through the fixing member (Paragraph 0169, The irrigation channel 36 may also be a component of the irrigant reservoir 30, or a separate component, or any combination. The stem 80 of the flexible tip may be positioned in fluid communication with the irrigant reservoir 30 via an irrigant reservoir port 35).
The irrigant reservoir port disclosed by Baker serves to maintain the connection between the irrigation channel and reservoir. However, if the Applicant is not convinced that this structure serves as a fixing member, Layer also discloses: wherein the pipeline assembly (Figure 13B, valve assembly 213) further comprises a fixing member (Figure 13B, irrigation control 520),
one end of the fixing member is communicated with the raw liquid tube, another end of the fixing member is communicated with the raw liquid tank, and the raw liquid tube is fixed to the raw liquid tank through the fixing member (Paragraph 0051, [0051] The irrigation control 520, as illustrated in FIGS. 13B and 15A in various embodiments, may be disposable between an irrigation position (on position) and an off position. The irrigation position may define a path of fluid flow of the irrigating fluid from the refill chamber 202, through the irrigation segment 502 of the bifurcated structure 501, into the applicator 203, and out of the plurality of apertures 250. The off position of the irrigation control 520, on the other hand, prevents irrigating fluid from entering into the irrigation segment 502 of the bifurcated structure 501. The irrigation control 520 may comprise a stopper 521 as illustrated in FIG. 15A, which may be disposable between an irrigation position, and the off position, and may be controlled through user interface 220. For instance, the irrigation control 520 may change from the irrigation position to the off position when the user interface 220, as illustrated in FIG. 15A is pressed or depressed)
Both Layer and Baker disclose nasal interfaces with controllable aspiration and irrigation features. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Layer’s irrigation control member to provide an additional degree of control over the flow of fluid, while also allowing for a more secure fluid connection between the reservoir and the nozzle port disclosed by Baker.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 20090281482 A1) in view of Tonomura (JP 2017213281 A), further in view of Baker et al. (US 20080154183 A1, hereinafter “Peter”).
Regarding Claim 7, Baker in view of Tomamura discloses all of the limitations of Claim 5. Baker further discloses:
pressure control means (Paragraph 0234, The pump 8 may have at least two oppositely-oriented oscillating shafts, rods, or membranes. In other embodiments, the pump 8 can be or have a compressed gas (e.g., air, carbon dioxide, nitrogen) canister 210 that can be configured to controllably store and release the compressed gas), (Paragraph 0130, The body 4 can have a fluid control system for irrigation and/or aspiration. The fluid control system can have one or more pumps 8 and 11. The fluid control system can have a driving motor 9),
and embodiments in which the raw liquid tank and waste liquid tank are in communication with one another (Paragraphs 0258-0259, The aspiration reservoir 256 can be in fluid communication with the irrigant reservoir 254, for example, via an irrigation-aspiration port 366. The irrigation-aspiration port 366 is configured to be away from the aspirant fluid level in the aspirant reservoir 256. An irrigation-aspiration valve 368 can be in fluid communication with the aspiration reservoir 256 and the irrigant reservoir 254. The irrigation-aspiration valve 368 can be a check valve. The irrigation-aspiration valve 368 can be a valve permitting flow only from the aspiration reservoir 256 to the irrigant reservoir 254 and preventing flow from the irrigant reservoir 254 to the aspiration reservoir 256)
However, Baker in view of Tonamura does not disclose a circulating air pipe. Peter does disclose: wherein the pipeline assembly further comprises a circulating air pipe (Paragraph 0071, an aspirant pressure line 18, atomizing channel 20 (or atomization channel), and irrigant pressure line 22 can be flexible and extendable. The irrigant channel 24 (e.g., at the irrigant pressure line 22), atomization channel 20, and aspirant channel 26 (e.g., at the aspirant pressure line 18) can each have a re-attachable division or split therein. The re-attachable division can connect in a male-female manner, such as a screw fit, snap fit, press fit, or combinations thereof),
the raw liquid tank is communicated with the waste liquid tank through the circulating air pipe (Paragraph 0076, The one or more pumps 8 and valves 10 can be in fluid communication with an aspirant pressure line 18, and/or an atomizing channel 20 and/or an irrigant pressure line 22. The control 32 can be configured to manage which valves 10 are open and closed, and/or how open and closed the valves 10 are, and/or what pumps 8 are on or off, and/or at what speed (e.g., flow rate and/or pressure) which pumps 8 operate. The pumps 8 and valves 10 can create positive and/or negative pressures in the aspirant pressure line 18, and/or atomizing channel 20, and/or irrigant pressure line 22),
and an air pressure in the raw liquid tank is identical to an air pressure in the waste liquid tank (Paragraphs 0019-0020, The fluid control system can be contained in the body. The fluid control system can be configured to irrigate at an irrigation pressure and aspirate at an aspiration pressure […] The fluid control system can be configured to simultaneously irrigate and aspirate. The fluid control system can be configured to vary the irrigation pressure at more than one non-zero pressure. The fluid control system can be configured to vary the pressure of aspiration at more than one non- zero pressure)
Both Peter and Baker disclose nasal interfaces with controllable aspiration and irrigation features. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Peter’s air pump arrangement with the cleaning system disclosed by Baker, so as to provide an additional means of controlling and maintaining pressure of irrigation and aspiration. This also serves to accommodate different users’ preferences and comfortability when using the device.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 20090281482 A1) in view of Tonomura (JP 2017213281 A), further in view of Hoke et al. (US 8048023 B2, hereinafter “Hoke”)
Regarding Claim 8, Baker in view of Tonomura discloses all of the limitations of Claim 4. Baker further discloses: wherein the raw liquid nozzle is inclined at an angle toward a direction close to the waste liquid nozzle, and the waste liquid nozzle is inclined at the same angle toward a direction close to the raw liquid nozzle (Paragraph 0088, FIG. 44 is a perspective view of a variation of an irrigation and aspiration device, showing the device including dual nozzles), (Paragraph 0286, Dual tips 194, 195 allow irrigant 32 to be expelled into one nostril while simultaneously or intermittently being aspirated out the other nostril (see FIG. 45)).
However, if the Applicant is not convinced, Hoke more explicitly depicts raw liquid nozzle is inclined at an angle toward a direction close to the waste liquid nozzle, and the waste liquid nozzle is inclined at the same angle toward a direction close to the raw liquid nozzle (Column 6, lines 7-11, The nasal interface is comprised of first and second nozzles 40, 42, which are also called nasal cushions, and which can swivel or pivot as may be necessary to form a cushioned seal against the nares, depending upon the personal anatomy of the user), (Column 6, lines 47-52, the supply conduit 46 directly communicates with first nozzle 40 so that the saline may be directed to the left nostril (as shown) of the user, pass through the nasal cavity and then be received in the second nozzle 42 for direct communication into the effluent bottle 14 through effluent conduit 50
Both Hoke and Baker disclose nasal interfaces with dual nozzles that serve to supply an irrigation liquid and collect the resulting waste liquid. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Hoke’s adjustable nose cushions with the removable nozzle tips disclosed by Baker, so as to better accommodate different users’ anatomy and maintain an effective seal when the device is in use (Hoke, Column 6, lines 11-31, A positive seal between the nasal cushions and a user's nares is essential to the successful operation of the device with respect to both its therapeutic function as well as to its distinguishing qualities of convenience, cleanliness and neatness […] The cushions 40, 42 may alternatively comprise communal nozzles that are easily removable and replaceable for convenient washing or for the attachment of a personal set of nozzles corresponding to distinct individual users. Adjustment to accommodate different nose sizes is accomplished by rotating supporting swivel gears 56 or by other generally understood mechanical means).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Liu (US 6736792 B1) discloses various embodiments of a dual-nozzled nasal-nasopharyngeal-cleaning system
Ma (CN 116139008 A, US 20240299244 A1) discloses a nasal cleaning device with controllable flow directions and water storage cavities
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights