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 .
Response to Amendment
This office action is responsive to the amendment filed on 05/27/2026. As directed by the amendment: claim 11 has been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-21 are presently pending in this application, with claims 1-10 and 12-16 being withdrawn from consideration.
Response to Arguments
Applicant's arguments on p.6-7 of “Remarks”, filed 05/27/2026, have been fully considered but they are not persuasive.
In response to the applicant’s argument that Baker in view of Erickson in view of Gallo fails to disclose or teach claim 11, the examiner respectfully disagrees.
Firstly, the applicant argues Baker’s “stem 80 does not have “one or more discharge apertures at a distal end thereof.” Rather, Baker’s bulbous tip 18 (which is clearly not tubular) includes its irrigation port”. This argument is not persuasive because (1) the claim limitation states one or more discharge apertures and Baker does disclose one irrigation port (34), and Baker further discloses that this may be one or more irrigation ports (34, see para. 0170). Further, as clarified below, the conduit is being interpreted as the flexible stem (80) of Baker with its integral tip (16) which together form a tubular structure as together they are a long, round, and hollow structure like a tube (see Fig. 16). Thus, Baker does disclose a flexible conduit that is tubular and has one or more discharge apertures at a distal end thereof configured to dispense lavage fluid as at least one fluid stream as claimed in claim 1.
Secondly, the applicant argues “The skilled artisan would therefore have no reason to modify Baker’s bulbous tip 18 to comprise “an adjustable semi-flexible conduit that is tubular, can bend and/or compress, and can maintain shaped when subjected to operating pressure”. This argument is not persuasive because the modification with Erickson in view of Gallo to modify the flexible conduit (18, 80) of Baker to be adjustable and semi-flexible as claimed does not render the bulbous tip (18) of Baker inoperable for its intended use for insertion into the nostril as Erickson explicitly teaches a nasal irrigator having a discharge portion (14 in Fig. 2) in the form of an elongated, bent tube having a distal tip (16) for insertion into the nostril in an analogous manner to Baker (see Col.2, lines 17-23 and Col.5, lines 8-15 of Erickson). Gallo further modifies this now elongated bent conduit to be adjustable and semi-flexible. Thus, the combination of Baker in view of Erickson in view of Gallo does not render Baker inoperable for its intended use, and the rejection is maintained.
Applicant’s argument that Ackerman fails to disclose “one or more discharge apertures at a distal end thereof” is not persuasive for the above discussed reasons. The limitations states one or more discharge apertures, and Ackerman does disclose a singular discharge aperture (distal opening of 160 in Fig. 4). Examiner clarifies below that the conduit is interpreted as the combined structure of the insertion tube (160) and the tube (130) such that the distal opening of (160) is interpreted as the one discharge aperture that is at a distal end of the conduit (130, 160). Examiner does note that not relied upon reference Rheiner et al. (U.S Patent Pub. No. 20210236712 A1, “Rheiner”) discloses a similar ear irrigation handpiece (500 in Fig. 5A) that teaches a plurality of egress ports (518, 520 in Fig. 5A) for providing a fluid stream into the ear (see para. 0073 and 0078). Therefore, the rejection is maintained.
Examiner suggests the following amendments to distinguish over the prior art. Fig. 5 of the instant application illustrates the discharge portion (52) having a “generally constant outer diameter along its entire length”. This amendment would overcome Baker as the conduit (18, 80) is formed with the bulbous tip (16) flaring outwardly, and thus does not have a generally constant outer diameter along its entire length. Examiner notes this amendment would not overcome Ackerman. Further, Fig. 5 illustrates the application member (50) with the connection port (51), discharge portion (52), and discharge apertures (53) being “an integral structure”. Baker only discloses that the stem (80) and tip (18) are integrally formed (see para. 0165), but does not disclose an integral connection port. Further, Ackerman discloses the conduit as the combined structure of the insertion tube (160) and the conduit (130), and thus does not disclose the discharge portion and the discharge apertures being an integral structure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (U.S Patent Pub. No. 20090281483 A1, “Baker”) in view of Erickson (U.S Patent Pub. No. 6361521 B1) in view of Gallo et al. (U.S Patent Pub. No. 20100114016 A1, “Gallo”).
Regarding claim 11, Baker discloses a system (2 in at least Fig. 3-4) for applying a lavage fluid to a surface (see para. 0110), the system (2) comprising:
a body (16 in Fig. 6) configured to house a lavage fluid (see Fig. 6 and para. 0112 and 0147– body 16 houses the irrigant reservoir 30); and
an application member (18 in Fig. 11A-12) in fluid communication with the body (16, see Fig. 11A-12 and para. 0174 – application member 18 is in fluid communication with irrigant reservoir 30 in body 16),
wherein the application member (18 in Fig. 16) comprises a flexible conduit (16, 80) that is tubular (see Fig. 16, see para. 0165-0166 – the flexible conduit is interpreted as the flexible stem 80 with its integrally formed bulbous tip 16 which have a generally tubular structure), wherein the flexible conduit (16, 80 in Fig. 16) comprises one or more discharge apertures (34) at a distal end (84 in Fig. 16) thereof (see para. 0170), the one or more discharge apertures (34) configured to dispense the lavage fluid as at least one fluid stream sufficient to provide an acceptable fluid flow force for a lavage process (see para. 0184 – application member 18 is configured to dispense the irrigant 32 as at least an unbroken fluid stream which provides an acceptable flow force for irrigation).
While Baker discloses the application member (18) comprises the flexible stem (80 in Fig. 16), the flexible stem is not disclosed as (Claim 11) an adjustable semi-flexible conduit that can bend or compress and can maintain shape when subjected to operating pressure.
Erickson discloses a nasal irrigation system (10 in Fig. 6) comprising a discharge portion (14 in Fig. 2) in the form of an elongated, bent tube and a distal tip (16 in Fig. 2, see Col.2, lines 17-23 and Col. 5, lines 8-15).
Since Baker discloses an application member (18) comprising a flexible stem (80) as the discharge portion and nozzle (84) that can seal at the subject’s nostril, and Erickson discloses an application member (14, 16) comprising a curved tube (14) and a distal tip (16) that can seal at the subject’s nostril, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the discharge portion of Baker to be a curved tube as taught by Erickson as the bend enables more convenient access of the application end, and more advantageous handling of a connected fluid reservoir (see Col.6, lines 37-45). In combination, flexible stem (80) of Baker forming part of the flexible conduit would be modified to be an elongated, curved tube (14) as taught by Erickson with the bulbous tip (16) still at it distal end as Erikson provides that the tube (14) has a degree of flexibility such that it would maintain the seal with the body (16) with the O-ring (86) as seen in Fig. 16 of Baker and still comprise the fluid channels (36, 46 in Fig. 16, see Baker, para. 0165).
While modified Baker discloses the elongated, flexible conduit, modified Baker still fails to disclose (Claim 11) an adjustable semi-flexible conduit that can bend or compress and can maintain shape when subjected to operating pressure.
Gallo discloses a nasal washing device (100 in Fig. 1) which comprises an atomizer (130 in Fig. 1) to spray a fine mist into the nasal passage (see para. 0024), wherein Gallo teaches (Claim 11) an adjustable semi-flexible conduit (134 in Fig. 1) that can bend or compress and can maintain shape when subjected to operating pressure (see para. 0024 – conduit 115 comprises a distal portion 134 that includes a bendable metal wire therein making it malleable to permit a user to bend the conduit while also allowing the conduit to maintain this orientation during normal operating pressure).
Since Erickson in modified Baker discloses elongated, curved tube that has an angle for more convenient access of the device end to the nasal passage (see Col. 5, lines 8-15), and Gallo discloses an elongated tube with an adjustable semi-flexible distal portion (134) that allows for the angle to be adjustable (see para. 0024), it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the elongated, flexible conduit of modified Baker to comprise an adjustable semi-flexible conduit as taught by Gallo. Gallo provides that the adjustable semi-flexible conduit permits a user to define and set a plurality of discharge direction or angled configuration without the conduit automatically returning to its original orientation (see para. 0006 and 0024). In Baker, such a modification would be motivated as it would allow the user to adjust the conduit and its discharge apertures to a desired angle or orientation that allows easier access to the nostril.
Regarding claim 20, modified Baker discloses the system of claim 11, as discussed above. In modified Baker, Baker discloses (Claim 20) wherein the lavage fluid comprises an antiseptic agent and water, the antiseptic agent comprising iodine (see para. 0123 – examiner notes the lavage fluid is a functional limitation and the body 16 is capable of being configured to housing the lavage fluid as claimed).
Regarding claim 21, modified Baker discloses the system of claim 11, as discussed above. In modified Baker, Gallo discloses (Claim 21) wherein the operating pressure comprises pressure from lavage fluid flow and pressure from handling by a user that is less than the pressure required by a user to adjust, bend, or compress the adjustable semi-flexible conduit (134, see para. 0024 – the distal portion 134 of discharge portion 115 comprises a bendable metal wire therein making it malleable to permit a user to bend the conduit while preventing the portion to return to its natural orientation during use, thus indicating the portion 134 can maintain shape when subjected to the lavage fluid flow and pressure from handling by the user that is less than the pressure required to bend the metal wire).
Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Erickson in view of Gallo as applied to claim 11 above, and further in view of Kim et al. (U.S Patent Pub. No. 20210060233 A1, “Kim).
Regarding claim 17, modified Baker discloses the system of claim 11, as discussed above.
While Baker, in modified Baker, discloses the modified discharge portion being nested with the body (16) with an O-ring to ensure sealing therebetween (see Fig. 19 and para. 0165 and 0168), modified Baker fails to disclose (Claim 17) wherein the application member comprises one or more protrusions, wherein the body comprises one or more corresponding protrusions, and wherein the one or more protrusions are configured to interact with the one or more corresponding protrusions to connect the application member with the body sufficient to provide fluid communication between the application member and the body.
Kim discloses a drug delivery device (10 in Fig. 1) for delivering medication into the nasal cavity (see para. 0033 and 0046), wherein the device (10) comprises a body (20 in Fig. 1) and an application member (30 in Fig. 2a) having a conduit (32 in Fig. 2a) and distal tip (30, in Fig. 2a, see para. 0046 and 0049). Kim teaches (Claim 17) wherein the application member (30 in Fig. 2a) comprises one or more protrusions (“screw threads” in para. 0059), wherein the body (20 in Fig. 2a) comprises one or more corresponding protrusions (“screw threads” in para. 0059), and wherein the one or more protrusions (“screw threads” in para. 0059) are configured to interact with the one or more corresponding protrusions (“screw threads” in para. 0059) to connect the application member (30) with the body (20) sufficient to provide fluid communication between the application member (30) and the body (20, see para. 0059 – the conduit 32 may comprise screw threads that interact with corresponding screw threads on the inlet 21 of the body 20 to detachably engage the application member 30 to the body 20 for fluid communication).
Since modified Baker discloses nested tubes with an O-ring for sealing as the connection between the modified conduit and the body, and Kim discloses a nested connection between the inlet (21) of the body (20) and the conduit (32) as seen in Fig. 2a and that this nested connection may be a threaded connection for both engagement and sealing, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the nested tube connection and sealing O-ring at the conduit and body of modified Baker to have a threaded connection on the conduit and body as taught by Kim according to known methods to yield predictable results. Separately, the nested tubes plus O-ring and threaded connection are both means to connect the application member to the body in a secure and sealed connection. Thus, the one of ordinary skill in the art would have recognized the results of such a modification yielding a threaded connection that is both secure and sealed for liquid communication would have been predictable. In combination, the modified conduit of modified Baker would comprise screw threads that interact with screw threads on the body to engage the application member to the body while maintaining fluid communication with both reservoirs of Baker.
Regarding claim 18, modified Baker discloses the system of claim 17, as discussed above. In modified Baker, Baker discloses (Claim 18) an actuator (208 in Fig. 46), wherein the system (2) is configured to dispense the lavage fluid upon actuation of the actuator (208, see para. 0293 – the device 2 may further comprise an actuator in the form of a trigger 208 configured to dispense the lavage fluid upon user actuation).
However, the embodiment shown in Fig. 46 of Baker fails to disclose the application member comprising the actuator.
The embodiment of Fig. 36 of Baker discloses an alternative system comprising an application member (259 in Fig. 36) comprising an actuator (348) which is user actuated to dispense lavage fluid (see para. 0257-0259).
Since, the embodiment of Fig. 46 of Baker discloses the system (2) having application member (18) and the actuator (208) disposed on the system (2) for dispensing lavage fluid, and the embodiment of Fig. 36 of Baker discloses the system may comprise an actuator (348) disposed directly on the application member (259) for dispensing lavage fluid, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the actuator of the embodiment of Fig. 46 of Baker to be disposed on the application member as taught by the embodiment of Fig. 36 according to known methods to yield predictable results. Both actuators are user operated triggers that when pulled or squeezed, cause the irrigant to dispense from the application member. Thus, one of ordinary skill in the art would have recognized that placing the actuator on the application member of the embodiment of Fig. 46 would yield predictable results.
Regarding claim 19, modified Baker discloses the system of claim 18, as discussed above. In modified Baker, Baker discloses (Claim 19) wherein the system (2) comprises a cartridge (210 in Fig. 47) containing a propellant (see para. 0294).
Claim(s) 11, 17-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ackerman (U.S Patent No. 10525191 B1) in view of Gallo et al. (U.S Patent Pub. No. 20100114016 A1, “Gallo”).
Regarding claim 11, Ackerman discloses the limitations of (Claim 11) a system (100 in Fig. 1) for applying a lavage fluid to a surface (see Col.4, lines 5-14), the system (100) comprising: a body (111 in Fig. 1) configured to house a lavage fluid (see Col.4, lines 11-13); and an application member (112, 130, and 160 in Fig. 1) in fluid communication with the body (111, see Col.4, lines 48-50 and lines 57-62, and Col.6, lines 29-31 – spray head 112, conduit tube 130, and insertion tube 160 are together interpreted as the application member as they are interconnected structures for the application of the irrigation fluid), wherein the application member (112, 130, 160) comprises a conduit (130, 160) that is tubular (see Fig. 1 and 4 – examiner is interpreting the conduit as the combined structure of the conduit 130 and insertion tube 160), wherein the conduit (130) comprises one or more discharge apertures (distal opening of 160 in Fig. 4) at a distal end thereof (see Fig. 4 and Col.4, lines 53-63 – distal end of insertion tube 160 has a distal opening), the one or more discharge apertures (distal opening of 160) configured to dispense the lavage fluid as at least one fluid stream sufficient to provide an acceptable fluid flow force for a lavage process (see Col.5, lines 1-9 for conduit and see Col.6, lines 48-63 – insertion tube 160 has a narrowing of diameter at its distal opening used to speed upon the fluid stream to provide acceptable flow force for ear irrigation).
While Ackerman discloses the conduit (130, 160) is preferably flexible but also may be semi-rigid (see Col.4, lines 45-46 and Col.5, lines 53-54), Ackerman fails to disclose (Claim 11) an adjustable semi-flexible conduit that can bend or compress and can maintain shape when subjected to operating pressure.
Examiner notes the invention of Gallo is a nasal washing device; however, the adjustable semi-flexible conduit of Gallo would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of manipulatable conduits for irrigation devices for orifices of the body. Gallo discloses a nasal washing device (100 in Fig. 1) which comprises an atomizer (130 in Fig. 1) to spray a fine mist into the nasal passage (see para. 0024), wherein Gallo teaches (Claim 11) an adjustable semi-flexible conduit (134 in Fig. 1) that can bend or compress and can maintain shape when subjected to operating pressure (see para. 0024 – conduit 115 comprises a distal portion 134 that includes a bendable metal wire therein making it malleable to permit a user to bend the conduit while also allowing the conduit to maintain this orientation during normal operating pressure).
Since Ackerman discloses the conduit (130, 160) may be flexible or semi-rigid and is used to position the nozzle at the ear canal (see Col.5, lines 9-12 and lines 53-54), and Gallo discloses the an elongated tube with an adjustable semi-flexible distal portion (134) that allows for discharge direction to be customized (see para. 0024), it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the conduit, specifically conduit (130), of Ackerman to comprise an adjustable semi-flexible conduit as taught by Gallo. Gallo provides that the adjustable semi-flexible conduit permits a user to define and set a plurality of discharge directions or angled configurations without the conduit automatically returning to its original orientation (see para. 0006 and 0024). In Ackerman, such a modification would be motivated as it would allow the user to adjust the conduit to a desired orientation that allows easier access to the ear canal and to a desired discharge direction for clearing ear wax at different locations in the ear canal.
Regarding claim 17, modified Ackerman discloses the system of claim 11, as discussed above. In modified Ackerman, Ackerman discloses (Claim 17) wherein the application member (112, 130, 160 in Fig. 1) comprises one or more protrusions (see Col.4, lines 47-51 – head 112 may comprise screw threads), wherein the body (111 in Fig. 1) comprises one or more corresponding protrusions (see Col.4, lines 47-51 – body 111 may comprise complementary screw threads), and wherein the one or more protrusions are configured to interact with the one or more corresponding protrusions to connect the application member (112, 130, 160) with the body (111) sufficient to provide fluid communication between the application member (112, 130, 160) and the body (111, see Fig. 1 and Col.4, lines 47-51).
Regarding claim 18, modified Ackerman discloses the system of claim 17, as discussed above. In modified Ackerman, Ackerman discloses (Claim 18) wherein the application member (112, 130, 160 in Fig. 1) comprises: an actuator (114 in Fig. 1), wherein the system (100 in Fig. 1) is configured to dispense the lavage fluid upon actuation of the actuator (114, see Col.7, lines 61-67 – Col.8, line 1).
Regarding claim 20, modified Ackerman discloses the system of claim 11, as discussed above. In modified Ackerman, Ackerman discloses (Claim 20) wherein the lavage fluid comprises an antiseptic agent and water, the antiseptic agent comprising iodine (see Col.4, lines 15-18 – examiner notes the lavage fluid is a functional limitation and the body 111 is capable of being configured to housing the lavage fluid as claimed).
Regarding claim 21, modified Ackerman discloses the system of claim 11, as discussed above. In modified Ackerman, Gallo discloses (Claim 21) wherein the operating pressure comprises pressure from lavage fluid flow and pressure from handling by a user that is less than the pressure required by a user to adjust, bend, or compress the adjustable semi-flexible conduit (134, see para. 0024 – the distal portion 134 of discharge portion 115 comprises a bendable metal wire therein making it malleable to permit a user to bend the conduit while preventing the portion to return to its natural orientation during use, thus indicating the portion 134 can maintain shape when subjected to the lavage fluid flow and pressure from handling by the user that is less than the pressure required to bend the metal wire).
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.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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