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 .
Acknowledgment
Claims 1, 16 are amended as filed on 12/19/2025.
Claims 21 is canceled and claim 22 is newly added.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
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) 1-6, 9, 10, 12-14, 16, 18, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US. 5882319) (“Olson ”) in view of Shelton et al. (US. 20180125346A1) (“Shelton”) and further in view of Hardgrove (US. 3224437).
Re claim 1, Olson discloses a medical lavage device (10, Fig. 1a-13, abstract) comprising: a container (50); a handle (20), the handle surrounding at least a portion of the container (Fig. 2); a liquid outlet (12) in fluid communication with the container (Col. 3, line 65 up to Col. 4, lines 3), the liquid outlet comprising a nozzle (12) configured for a lavage procedure (Fig.2, Col. 3, line 65 up to Col. 4, lines 3, abstract), wherein the adjusted fluid stream is delivered to a treated area during the lavage procedure (the fluid can be adjusted by the pump on or off to reach the cavity Co. 3, lines 35-40) and wherein the medical lavage device is configured to permit the fluid to freely flow away from the treated area during the lavage procedure (the lavage device is capable to permit the fluid to freely flow away from the treated area, Col. 4, lines 48-56), whereby wax or foreign matter is removed from the treated area by the adjusted fluid stream (Col. 4, lines 48-56); a light source (38) retained on an external surface of the medical lavage device (38 is retained to 26, Fig. 2) relative to the liquid outlet (Fig. 2) such that light emitted from an end of the light source illuminates a liquid delivery area for liquid delivered from the container through the liquid outlet (Col. 3, lines 34-40), wherein the treated area comprises at least a portion of the liquid delivery area (Col. 3, lines 34-40);, but it fails to disclose that the nozzle is rotatable nozzle so that the rotatable nozzle configured to rotate about an axis, whereby at least one of a shape and a pressure of a fluid stream exiting the outlet is adjusted based on the rotational position of the rotatable nozzle, and a magnifying lens movably retained on an external surface of the device so as to allow for a range of motion of the magnifying lens around the external surface of the device, wherein the magnifying lens is configured to be retained on the device at a location that is farther from the liquid outlet as compared to the end of the light source such that the magnifying lens enables magnified viewing of the liquid delivery area in addition to an external portion of the medical lavage device including the liquid outlet.
However, Shelton discloses an ear speculum tip (nozzle, Figs. 1-8) wherein the nozzle (100) is rotatable (¶0054) and configured to rotate about an axis (¶0054), the rotatable nozzle configured to rotate about an axis, whereby at least one of a shape and a pressure of a fluid stream exiting the outlet is adjusted based on the rotational position of the rotatable nozzle (Fig. 2c-2, ¶0055).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the nozzle of Olson so that the nozzle is rotatable and the rotatable nozzle configured to rotate about an axis, whereby at least one of a shape and a pressure of a fluid stream exiting the outlet is adjusted based on the rotational position of the rotatable nozzle as taught by Shelton for the purpose of easily sealing the ear and optimizing the delivery of the fluid/air (Shelton. ¶0044).
Olson in view of Shelton fails to disclose a magnifying lens movably retained on an external surface of the device so as to allow for a range of motion of the magnifying lens around the external surface of the device, wherein the magnifying lens is configured to be retained on the device at a location that is farther from the liquid outlet as compared to the end of the light source such that the magnifying lens enables magnified viewing of the liquid delivery area in addition to an external portion of the medical lavage device including the liquid outlet.
However, Hardgrove teaches an ear canal/nasal examining instrument (Fig. 1-6, abstract) and wherein a magnifying lens (14, Col. 1, lines 68-72) movably retained on an external surface of the device (10, Col. 1, lines 68-72, it can be moved with 20 due to the sliding bar 16 an the lock 18 ) so as to allow for a range of motion of the magnifying lens around the external surface of the device (Fig. 6), wherein the magnifying lens is configured to be retained on the device at a location that is farther from the liquid outlet (28) as compared to the end of the light source (12, Col. 1, lines 68-72) such that the magnifying lens enables magnified viewing of the liquid delivery area in addition to an external portion of the medical lavage device including the liquid outlet ( the lens is a magnifying lens to search the treated area and end of speculum).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified device of Olson to include a magnifying lens so that a magnifying lens movably retained on an external surface of the device so as to allow for a range of motion of the magnifying lens around the external surface of the device, wherein the magnifying lens is configured to be retained on the device at a location that is farther from the liquid outlet as compared to the end of the light source such that the magnifying lens enables magnified viewing of the liquid delivery area in addition to an external portion of the medical lavage device including the liquid outlet as taught by Hardgrove for the purpose of facilitating viewing and removal of foreign bodies (Hardgrove , Col. 3, lines 10-25).
Re claim 2, Olson discloses a pump (60) in fluid communication with the container and the liquid outlet (Fig. 2), the pump comprising adjustment capabilities configured to adjust the flow of fluid from the outlet during use, whereby at least one of a pressure of the fluid at the outlet, a flow rate of the fluid through the outlet, and continuous or pulsatile flow through the outlet is adjusted (Col. 3, lines 42-60, the rate).
Re claim 3, Olson discloses a power source (30, Fig. 2) is in electrical communication with the pump (Fig. 2, Col. 3, lines 18-29).
Re claim 4, Olson discloses wherein the power source (30) is in electrical communication with the light source (Col. 3, lines 30-40, Fig. 5).
Re claim 5, Olson fails to disclose an attachment.
However, Shelton discloses an ear speculum tip (nozzle, Figs. 1-8) wherein the nozzle (100) is rotatable (¶0054) and configured to rotate about an axis (¶0054), an attachment (Fig. 29a-b,).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the nozzle of to include an attachment as taught by Shelton for the purpose of easily sealing the ear and optimizing the delivery of the fluid/air (Shelton. ¶0044).
Re claim 6, Olson fails to disclose the attachment comprising a luer taper fitting.
However, Shelton discloses an ear speculum tip (nozzle, Figs. 1-8) wherein the nozzle (100) is rotatable (¶0054) and configured to rotate about an axis (¶0054), the attachment comprising a luer taper fitting (Fig. 29a-b).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the nozzle of to include an attachment as taught by Shelton for the purpose of easily sealing the ear and optimizing the delivery of the fluid/air (Shelton. ¶0044).
Re claim 9, Olson is silent to the specifics of the container that defines a volume of about 600 milliliters or less. The instant disclosure describes the parameter of the volume of the container as being merely preferable, and does not describe the volume of the container as contributing any unexpected results to the system (see the ¶0019 of the current application). As such, parameters such as the volume of the container are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the volume of the container would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Re claim 10, Olson discloses wherein the device is a single-use, disposable device ( “a single use, disposable device” is an intended use limitation that do not result in structural difference, Col. 3, lines 9-15).
Re claim 12, the modified Olson discloses a kit comprising the medical lavage device of claim 1 and one or more removably attachable accessory devices (speculum /nozzles and/or batteries, see Shelton Fig 9a).
Re claim 13, Olson discloses the accessory devices comprising one or more delivery catheters, a splash guard, a penetration depth guard, a bulb syringe, one or more batteries, one or more additional light sources, or a combination thereof (batteries 30 or light 38, Fig. 2).
Re claim 14, the modified Olson discloses the accessory devices comprising multiple delivery catheters that differ from one another with regard to length and/or gauge (other additional nozzle that can be used see Shelton Fig 9a).
Re claim 16, Olson discloses a method for irrigating a treated an area in a medical lavage treatment (10, Fig. 1a-13, abstract), the method comprising: placing an amount of a liquid into a container (50, Col. 3, lines 65-67), the container being at least partially surrounded by a handle of a medical lavage device (20, Fig. 2); directing a light (38) at the treated area, the light being emitted from an end of a light source of the device (the cavity Co. 3, lines 35-40), the light source retained on an external surface of the device (Fig. 2); adjusting a fluid delivery from a pump coupled to the container (Col. 3, lines 42-60, pump 60), wherein adjusting the fluid delivery comprises a nozzle (12); delivering the liquid by the pump using the adjusted fluid delivery from a liquid outlet of the container to the treated area in conjunction with the directing of the light at the area during the medical lavage treatment (Co. 3, lines 35-40), wherein the liquid is permitted to freely flow away from the treated area (the lavage device is capable to permit the fluid to freely flow away from the treated area, Col. 4, lines 48-56), whereby wax or foreign matter is removed from the treated area by the liquid (Col. 4, lines 48-56), but it fails to disclose that the nozzle is rotatable nozzle to select at least one of a fluid pressure, a flow rate, and continuous or pulsatile flow; and locating a magnifying lens on the device such that the magnifying lens is at a location that is farther from the liquid outlet as compared to the end of the light source; and wherein the magnifying lens is movably retained on the outside of the device such that a view field of the magnifying lens is directed at the treated area and enables magnified viewing of the treated area and an external portion of the device including the liquid outlet, whereby the magnifying lens is movable within a range of motion around the outside of the device.
However, Shelton discloses an ear speculum tip (nozzle, Figs. 1-8) wherein the nozzle (100) is rotatable (¶0054) and configured to rotate about an axis (¶0054), adjusting the fluid delivery comprises rotating a nozzle to select at least one of a fluid pressure, a flow rate and continuous or pulsatile flow (Fig. 2c-2, ¶0055).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the nozzle of Olson so that the nozzle is rotatable nozzle to select at least one of a fluid pressure, a flow rate, and continuous or pulsatile flow as taught by Shelton for the purpose of easily sealing the ear and optimizing the delivery of the fluid/air (Shelton, ¶0044).
Olson in view of Shelton fails to disclose that locating a magnifying lens on the device such that the magnifying lens is at a location that is farther from the liquid outlet as compared to the end of the light source; and wherein the magnifying lens is movably retained on the outside of the device such that a view field of the magnifying lens is directed at the treated area and enables magnified viewing of the treated area and an external portion of the device including the liquid outlet, whereby the magnifying lens is movable within a range of motion around the outside of the device
However, Hardgrove teaches an ear canal/nasal examining instrument (Fig. 1-6, abstract) and wherein a magnifying lens (14, Col. 1, lines 68-72) movably retained on an external surface of the device (10, Col. 1, lines 68-72, it can be moved with 20 due to the sliding bar 16 an the lock 18 ) so as to allow for a range of motion of the magnifying lens around the external surface of the device (Fig. 6), wherein the magnifying lens is configured to be retained on the device at a location that is farther from the liquid outlet (28) as compared to the end of the light source (12, Col. 1, lines 68-72) and wherein the magnifying lens is movably retained on the outside of the device such that a view field of the magnifying lens is directed at the treated area and enables magnified viewing of the treated area and an external portion of the device including the liquid outlet, whereby the magnifying lens is movable within a range of motion around the outside of the device ( the lens is a magnifying lens to enable the user to see the treated area and end of speculum).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified method of Olson to include a step of locating a magnifying lens on the device such that the magnifying lens is at a location that is farther from the liquid outlet as compared to the end of the light source; and wherein the magnifying lens is movably retained on the outside of the device such that a view field of the magnifying lens is directed at the treated area and enables magnified viewing of the treated area and an external portion of the device including the liquid outlet, whereby the magnifying lens is movable within a range of motion around the outside of the device as taught by Hardgrove for the purpose of facilitating viewing and removal of foreign bodies (Hardgrove , Col. 3, lines 10-25).
Re claim 18, Olson discloses wherein the method is an ear lavage method, an eye lavage method, or a wound lavage method (Co. 3, lines 35-40, wound or any cavity).
Re claim 22, Olson discloses wherein the treated area comprises a tissue compartment within a human body (Co. 3, lines 35-40, wound or any cavity).
Claim(s) 8, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Shelton and Hardgrove and further in view of Bansal et al. (US. 20160279321A1) (“Bansal”).
Re claim 8, Olson in view of Shelton and Hardgrove fails to disclose that the light source comprising a light emitting diode and/or an ultra-violet light emitting device.
However, Bansal discloses an ear cleaning device (Figs. 1- 3) comprising a light source comprising a light emitting diode (¶0013, LED).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Olson so that the light source comprising a light emitting diode and/or an ultra-violet light emitting device as taught by Bansal for the purpose of as an art recognized light to emit light that enable real time viewing the ear canal (Bansal, ¶0013).
Re claim 11, Olson in view of Shelton and Hardgrove fails to discloses a heater configured to heat a liquid held within the container.
However, Bansal discloses an ear cleaning device (Figs. 1- 3) comprising a heater configured to heat a liquid held within the container (heater with reservoir within 33, Fig.1, ¶0018).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Olson to include a heater configured to heat a liquid held within the container as taught by Bansal for the purpose of safely delivering the liquid at specific and maintained temperature (Bansal, ¶0009).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Shelton and Hardgrove and further in view of Truong et al. (US. 20110295073A1) (“Truong”).
Re claim 7, Olson in view of Shelton and Hardgrove fails to disclose that the device comprising distance markings at the liquid outlet.
However, Truong discloses an ear device (Figs. 1-9e) the device comprising distance markings at the liquid outlet (¶0037, wherein the body of 120, 120a, 120b has marks that give indication of the insertion distance).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Olson to include distance markings at the liquid outlet as taught by Truong for the purpose of preferably having frustoconical profile that allow with preferable lengths section (Truong, ¶0040).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Shelton and Hardgrove and further in view of Ginsberg (US. 5527275).
Re claim 15, Olson in view of Shelton and Hardgrove fails to disclose the one or more accessory devices comprising a bulb syringe and a penetration depth guard, the penetration depth guard being removably attachable to both the bulb syringe and the medical lavage device.
However, Ginsberg discloses a kit (Fig. 1-4) wherein the kit has one or more accessory devices (3, 10, 9) comprising a bulb syringe (3) and a penetration depth guard (9 and/or 10), the penetration depth guard being removably attachable to both the bulb syringe and the medical lavage device (21, 1).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Olson to include one or more accessory devices comprising a bulb syringe and a penetration depth guard, the penetration depth guard being removably attachable to both the bulb syringe and the medical lavage device as taught by Ginsberg for the purpose of adapting a standard pump and providing a manual control of the flow (Ginsberg, Co. 3, lines 19-25, Col. 3, lines 50-63).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Shelton and Hardgrove and further in view of Bansal et al. (US. 20160279321A1)(“Bansal”).
Re claim 19, Olson in view of Heine fails to disclose wherein the light comprises white light or ultra-violet light.
However, Bansal discloses an ear cleaning device (Figs. 1- 3) comprising a light source comprising a light emitting diode (¶0013, LED).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Olson so that the light source comprising a light emitting diode and/or an ultra-violet light emitting device as taught by Bansal for the purpose of as an art recognized light to emit light that enable real time viewing the ear canal (Bansal, ¶0013).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Shelton and Hardgrove and further in view of Liu et al. (US. 20140171794) (“Liu”).
Re claim 20, Olson in view of Heine fails to disclose wherein the liquid comprises a detection solution, the method further comprising delivering a second liquid to the area, the second liquid comprising a rinsing solution.
However, Liu teaches a nasal irrigation system (¶0019 wherein the liquid (labeling liquid, ¶0024 comprises a detection solution (diagnostic agent, ¶0011; labeling agents, ¶0022-¶0024), the method further comprising delivering a second liquid to the area, the second liquid (cleansing liquid, ¶0024 comprising a rinsing solution (cleansing solution is scientifically formulated with citric acid and sodium citrate, ¶0021).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Olson to include a liquid comprises a detection solution so that the liquid comprises a detection solution, the method further comprising delivering a second liquid to the area, the second liquid comprising a rinsing solution as taught by Liu for the purpose of diagnosing and then treating and cleaning the treatment area with a quick recovery effect without any side effect (Liu, ¶0024).
Response to Arguments
Applicant’s arguments, see remark, filed 12/19/2025, with respect to the rejection(s) of claim(s) 1, 16 under 103 using Rogers have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Olson in view of Shelton and Hardgrove.
Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783