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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/16/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 01/16/2026. As directed by the amendment: claims 11 and 21 have been amended, claim 22 has 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 Thus, claims 1-21 are presently pending in this application, with claims 1-10 and 12-16 being withdrawn from consideration. Applicant’s amendments to the claims have overcome 112(b) rejections set forth in the Final Office Action mailed on 10/27/2025. Examiner invites applicant to set up an interview to discuss amendments to overcome the rejection of record.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 discharge portion (80 in Fig. 16) and a nozzle (84 in Fig. 16) 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. 0165-0166 – application member 18 is a nozzle and thus its distal end 84 is a nozzle, 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 a discharge portion in the form of a flexible stem (80 in Fig. 16), the flexible stem is not disclosed as comprising (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, the discharge portion (80) in the form of the flexible stem of Baker would be modified to be an elongated, curved tube (14) as taught by Erickson which 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 Erickson in modified Baker discloses the discharge portion having a flexible conduit (14), 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) wherein the discharge portion (115 in Fig. 1) comprises 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 the discharge portion (14) as 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 the discharge portion (115) being an elongated tube with an adjustable semi-flexible distal portion (134) that allows for the angle of the discharge portion (115) 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 discharge portion of modified Baker to comprise an adjustable semi-flexible conduit as taught by Gallo. Gallo provides that the adjustable semi-flexible conduit of the discharge portion permits a user to define and set a plurality of discharge direction or angled configuration without the discharge portion 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 discharge portion 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 discharge portion (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 discharge portion 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 discharge portion and the body, and Kim discloses a nested connection between the inlet (21) of the body (20) and the discharge potion (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 discharge portion and body of modified Baker to have a threaded connection on the discharge portion 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 discharge portion 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 discharge portion (130 in Fig. 1) and a nozzle 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 discharge portion and see Col.6, lines 48-63 – examiner notes a nozzle is being interpreted under BRI using Merriam Webster’s definition of a short tube with a taper or constriction used to speed up or direct a flow of fluid, the nozzle is being interpreted as the distal portion of conduit 130, connector 150, and insertion tube 160 which are a portion of tubing having a narrowing of diameter at insertion tube 160 used to speed upon the fluid stream to provide acceptable flow force for ear irrigation).
While Ackerman discloses the discharge portion (130) is preferably flexible but also may be semi-rigid (see Col.5, lines 53-54), Ackerman fails to disclose (Claim 11) the discharge portion comprises 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) wherein the discharge portion (115 in Fig. 1) comprises 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 discharge portion (130) 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 discharge portion (115) being 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 discharge portion of Ackerman to comprise an adjustable semi-flexible conduit as taught by Gallo. Gallo provides that the adjustable semi-flexible conduit of the discharge portion permits a user to define and set a plurality of discharge direction or angled configuration without the discharge portion 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 discharge portion 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783