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
The amendment filed on 02/24/2026 has been entered. Claims 1, 3-4, 8, and 17 are pending in this application. Claim 1 and 8 are amended. Claim 2, 5-7, 9-16, and 18-24 are cancelled.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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. More specifically, the amended claim limitation “wherein the fluid channel comprises at least one one-way valve that prevents lavage fluid from passing through the fluid channel, and wherein the one-way valve has a first, closed position that prevents fluid passage from inside the body and a second, open position that allows fluid passage from the external environment…” further narrows the scope of the claimed invention.
Though overall some of the same prior art references are used herein, at least applicant’s amended independent claim 1 required a change in the grounds of the rejection as detailed below in the prior art rejection.
Claim Objections
Claim 1 is objected to because of the following informalities: line 7: “and a through a…” should read “and through a”. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Meierhoefer (Patent No. US 4,533,068 A) in view of Gallo et al. (Publication No. US 2012/0323221 A1).
Regarding claim 1, Meierhoefer teaches a system for applying a lavage fluid to a surface (device is used to deliver fluid to a surface; Abstract; Figure 1; Column 2, lines 5-15), the system comprising:
a compressible body forming a housing (compressible container body 14 forms a housing; Figure 1; Column 3, lines 61-68), wherein the housing forms a chamber containing a lavage fluid (container 14 housing has a chamber to hold fluid; Figure 1; Column 3, lines 61-68), and wherein the body is configured such that at least a portion of the lavage fluid is dispensed upon compression of the body (container 14 when squeezed dispenses fluid; Column 3, lines 61-68);
a venting adaptor (venting device 10; Figure 1; Column 3, lines 61-68), wherein the venting adaptor comprises:
a fluid channel configured to provide fluid communication between the housing and an external environment for equalizing pressure within the compressible body (return air port 18 to restore air in the container 14 by taking in air from the environment; Figure 1-2; Column 4, lines 20-22),
a first connection portion configured to connect with a body connection portion of the body (formed body of device 10 has threading to connect with threading on container; Figure 1; Column 4, lines 1-5),
at least one filter provided relative to the fluid channel sufficient to filter air passing through the fluid channel (filter 52 is provided on the port 18 to filter microorganisms from incoming air from the environment; Figure 2; Column 4, lines 52-68),
wherein the venting adaptor comprises at least a portion of the flow path along which the lavage fluid is dispensed (device 10 contains the flow path where the fluid is dispensed in the direction of the port 20; Figure 1-2),
wherein at least a portion of the fluid channel is separate from the fluid flow path and is configured to provide air from the external environment to the same chamber that contains the lavage fluid upon a re-equilibrium period (port 18 is separate from port 10 and is to provide air from environment to the chamber of container 14 after compression is complete; Figure 1-2). Meierhoefer does not teach an application member in fluid communication with the body, wherein the application member is configured to dispense the lavage fluid along a flow path and a through a discharge aperture; and a second connection portion configured to connect with the application member, wherein the fluid channel comprises at least one one-way valve that prevents lavage fluid from passing through the fluid channel, and
wherein the one-way valve has a first, closed position that prevents fluid passage from inside the body and a second, open position that allows fluid passage from the external environment.
Gallo teaches an application member in fluid communication with the body (application tip 215 in communication with bottle; Figure 57; Paragraph 0114-0115), wherein the application member is configured to dispense the lavage fluid along a flow path and a through a discharge aperture (applicator tip 215 has an aperture for dispensing fluid to dispense fluid through the flow path from the chamber and out of the bottle; Figure 57; Paragraph 0114-0115); and a second connection portion configured to connect with the application member (tapered spout portion 223 is configured to be connected to the applicator tip 215; Figure 57; Paragraph 0114-0115), wherein the fluid channel comprises at least one one-way valve that prevents lavage fluid from passing through the fluid channel (valve 198 is one-way and prevents fluid from passing through tube 193; Paragraph 0110; Figures 45-46), and
wherein the one-way valve has a first, closed position that prevents fluid passage from inside the body and a second, open position that allows fluid passage from the external environment (closed position prevents fluid to leave from bottle 24 and through tube 193 and open position allows air to enter into the bottle 24 from environment; Figures 45-46; Paragraph 0110).
Gallo and Meierhoefer are considered to be analogous to the claimed invention because they are in the same field of lavage/irrigation devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meierhoefer to incorporate the teachings of Gallo to have the application member of Gallo to be sized to fit on the venting adapter on top of port 20 of Meierhoefer with port 20 having the tip be shaped with the second connection portion of Gallo and to have the one-way valve of Gallo in the fluid channel of Meierhoefer. This allows for the user to removably connect the soft applicator tip when desired (Gallo; Paragraph 0114-0115) and for the valve to allow air to enter in the bottle and prevent fluid from the chamber to enter into the tube (Gallo; Paragraph 0110).
Regarding claim 3, Meierhoefer in view of Gallo teaches the system of claim 1. Meierhoefer further teaches wherein: the venting adaptor comprises a restrictive feature at a position along the flow path (check valve 28 is in flow path; Figure 2; Column 4, lines 23-50), and the restrictive feature is configured to prevent gas from the external environment from entering the body via the flow path (check valve 28 prevents air to travel through; Figure 2; Column 4, lines 23-50).
Regarding claim 4, Meierhoefer in view of Gallo teaches the system of claim 3. Meierhoefer further teaches wherein the restrictive feature comprises a one-way valve (duck-bill check valve 28 is a one-way valve; Column 4, lines 23-51; Figure 2), the one-way valve comprising:
a first, closed position (valve 28 has closed position; Figure 2; Column 4, lines 23-51); and
a second, open position (valve 28 has an opposing opened position; Figure 2; Column 4, lines 23-51),
wherein the one-way valve is configured to be in the first position when subjected to pressure from a first direction (pressure entering into port 20 keeps valve 28 closed; Figure 2; Column 4, lines 23-51),
wherein the one-way valve is configured to move to the second position when subjected to pressure from a second direction (valve 28 has opposing open position when pressure from compressing the bottle moves the valve open in the opposing direction; Figure 2; Column 4, lines 23-51),
wherein the second direction is different from the first direction (open and closed positions are based on pressures applied in opposing directions; Column 4, lines 23-51).
Regarding claim 17, Meierhoefer in view of Gallo teaches the system of claim 1. However, Meierhoefer in view of Gallo does not expressly disclose that the filter has an average pore size of up to about 10 pm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the filter has an average pore size of up to about 10 pm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04)(IV)(A). In the instant case, the lavage system of Meierhoefer in view of Gallo would not operate differently with the claimed filter’s pore size since it has the same function of filtering contaminants from the environment to deliver clean fluid to the wound area. Further, applicant places no criticality on the range claimed, indicating simply that the pore is “about” within the claimed ranges (specification; paragraph 00111).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Meierhoefer (Patent No. US 4,533,068 A) in view of Gallo et al. (Publication No. US 2012/0323221 A1), as applied to claim 1 above, and further in view of Drinan (U.S. Patent Application No. 2003/0145849 A1).
Regarding claim 8, Meierhoefer in view of Gallo teaches the system according to claim 1. The combination of Meierhoefer in view of Gallo does not teach wherein the fluid channel further comprises a selective membrane.
However, Drinan teaches wherein the fluid channel further comprises a selective membrane (fluid channel with valve 109 has filter 108; Figure 7B).
Drinan and Meierhoefer in view of Gallo are both considered to be analogous to the claimed invention because they are in the same field of lavage/irrigation devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meierhoefer in view of Gallo to incorporate the teachings of Drinan have the filter be a restrictive feature in the fluid channel of Meierhoefer in view of Gallo. This allows for the excess gas that is incoming from the cavity to be filtered into the device, but not the fluid from the cavity (Drinan; Paragraph 0072).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781