DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 2, 2026 has been entered.
Response to Arguments
Applicant's arguments filed April 2, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the claims, as amended, overcome the previous rejection, the Examiner respectfully disagrees. As set forth below, Burt teaches a plurality of openings for delivering a fluid from an orifice of the trocar. Suehara is relied upon to teach the use of venting channels in a cleaning device for endoscopes which comprises a plurality of channels which may irrigate or aspirate fluid from the channel for receiving the endoscope. In this manner, the channel 10d of Suehara may be used to modify the trocar assembly of Burt to provide venting means proximal to the flow openings present in the device of Burt. Therefore, the cited references still render obvious the claim limitations as set forth below.
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) 21-25 and 27-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burt et al. (US 2019/0125176) in view of Suehara et al. (US 2015/0190041) and further in view of Fujimoto (US 2011/0230716).
Regarding claim 21, Burt et al. (henceforth Burt) discloses a method for cleaning an endoscope during a procedure (e.g., paragraph [0030]), the method comprising delivering, utilizing a trocar (100) comprising a main body defining a cavity for receiving an endoscope (Figure 3A; 302), a flow of wash solution and pressurized gas into the cavity via at least one orifice of the trocar to generate spray of the wash solution (paragraphs [0033] and [0047] disclose that gas outlets 104 and liquid outlets 106 are used to deliver gas and fluid into the chamber of the trocar during use; the claim does not require the gas and wash solution to exit from the same orifice during the process); washing the endoscope in response to generating the atomized spray of the wash solution (paragraph [0047] discloses the fluid being delivered at an atomizing pressure; see also paragraph [0039] which discloses that the liquid outlets are formed with a cross-section for increasing liquid velocity as liquid transitions through the outlets which supports the increased pressure of the saline with respect to the fluid being atomized); delivering, after washing the endoscope, the pressurized gas into the cavity to dry the endoscope (paragraphs [0004] discloses the drying of the endoscope via application of gas after washing as a removal of fluid from the washed device) ; and managing residual fluids on the endoscope or in the cavity, or both (paragraphs [0004] discloses removing fluid via the application of gas and [0031]). Burt further discloses the expulsion of fluid from the fluid orifices at pressure as well as the mixing of fluid and gas within the device body (see e.g., paragraphs [0039] and [0047]; the gas is flowing throughout the procedure to maintain body cavity insufflation as per paragraph [0049] and so will mix with the liquid expelled during cleaning) but fails to explicitly teach the atomization of the liquid or the vents.
Suehara teaches a cleaning device for an elongated member comprising one or more vent apertures (e.g., openings in chamber connected to third lumen 10d; paragraph [0026] discloses that the supply/suction lumen, of which 10d is disclose as one, can be used to suck liquid out of the cleaning unit) formed through the main body, and which span a region around a distal portion of the trocar (the entire portion of Figure 2 may be considered as the distal end of the trocar; the openings 10d are radially offset around the circumference of the trocar as depicted in Figure 2), and wherein they avoid buildup of residual fluids on the endoscope or in the cavity or both (10d are disclosed as suction ports and, when used, will clear the trocar channel of any fluid or debris therein).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the chamber of Burt to comprise the third lumen taught by Suehara to provide a suction port within the chamber to remove any debris from the chamber as taught by Suehara (e.g., paragraph [0060]).
Burt and Suehara both fail to teach the step of atomizing the saline for washing. However, Fujimoto teaches a method for using an atomized wash spray to clean an endoscope (paragraphs [0003] and [0007]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Burt/Suehara to comprise the step of using an atomized fluid for cleaning a portion of an endoscope device since Fujimoto teaches that an atomized fluid is sufficient for cleaning adherents from a portion of an endoscope device during a cleaning procedure. Burt discloses structure and function (e.g., fluid ejection at pressure and into a constant gas stream environment) for creating an atomized fluid environment and Fujimoto teaches that such an environment is suitable for cleaning an endoscope during a procedure.
Regarding claims 22 and 25, Burt teach the method substantially as set forth above for claim 21, but fails to explicitly disclose one or more seals in the cavity.
Suehara et al. (henceforth Suehara) teaches (Figures 1-3) a cleaning device (1) for an elongated member (e.g., imaging member 100) wherein a main body (2) comprises a cavity (10L) which comprises one or more seals (e.g., cleaning unit 20 which includes first contact member 21 and second contact member 22 which are considered to seal against the imaging device; see e.g., Figure 3).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cavity of the device of Burt to comprise the cleaning contact members taught by Suehara so as to ensure the body and lens of the imaging device are sufficiently cleaned during use as taught by Suehara (paragraph [0062]).
Regarding claim 23, Burt discloses the claimed invention substantially as set forth above for claim 21, but fails to explicitly disclose the step of using suction to extract residual wash solution.
Suehara teaches the use of suction unit to remove fluid to a cleaning unit during a procedure (paragraphs [0026] and [0065]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cleaning method of Burt to apply suction during the cleaning procedure so as to allow for removal of excess wash fluid from the system as taught by Suehara.
Regarding claim 24, Suehara further teaches using rear gas pressure to prevent wash solution ingress during the washing and drying phases (paragraph [0106]).
Regarding claim 27, Suehara further teaches a drain or rib (e.g., second contact member 22) extending inwardly into the cavity (Figure 2) to passively allow wash solution to pass out of the trocar during the washing and drying (the contact member will create some barrier to flow during the cleaning which is considered to meet the limitation as currently set forth).
Regarding claim 28, Suehara further teaches wherein using the one or more physical seals to compartmentalize the wash solution includes using two physical seals (21 and 22) to prevent the wash solution from flowing proximally during the washing and from flowing out of the trocar during the drying (e.g., seal 22 prevents backflow during use from areas between 21 and 22).
Regarding claim 29, Suehara further teaches wherein the one or more seals comprises a lip seal (e.g., tips of 22).
Regarding claim 30, Suehara further teaches wherein the suction is at a flow rate that matches a flow rate of the pressurized gas into the cavity such that there is no net effect of gas flow into the cavity (paragraph [0066] discloses the gas may be normal pressure and not compressed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Burt to maintain inflow and outflow at the same rate so as to provide an environment which does not modify the cavity pressure during a procedure. Such a feature is known from Burt wherein paragraph [0050] set forth that liquid flow is selective to avoid flooding of the body cavity during a procedure which remains insufflated via the delivery of gas. In this manner, it would have been obvious to create a net zero flow dynamic through the device to maintain the site at a desired pressure as taught by Burt and Suehara.
Regarding claim 31, Burt further discloses wherein the delivery of the flow of wash solution is via a wash orifice (106), and the suction is implemented via a suction orifice (104) disposed near the wash orifice (Figure 1).
Regarding claim 32, Suehara further teaches wherein using the rear gas pressure to prevent ingress of the wash solution during the washing and drying includes generating a flow of the gas distally that is higher than that proximally to create a seal via the gas to prevent the ingress of the wash solution (paragraph [0066] sets forth that the gas may be delivered by compressed air and which would be supplied at a high pressure which would then apply at least some pressure against a flow of liquid moving against the gas flow as claimed; see also paragraph [0106] disclosing the gas reducing the liquid retention amount).
Regarding claim 33, Burt further discloses wherein the rear gas pressure is created via a rear gas port (end of gas ports 104) that is disposed in a portion of the trocar having an internal diameter that is smaller than that of a portion of the trocar disposed proximally (the port outlet is substantially smaller than the proximal end of the device as depicted in Figure 1).
Regarding claim 34, Burt further discloses wherein the rear gas pressure is created via a rear gas port that is disposed in a groove (gas outlet port formed in 104 is between outlet 106 and the outer body of the device which is considered to be in a groove as claimed).
Regarding claim 35, Suehara further teaches wherein the drain or rib (one of 22) is disposed at a distal end of the main body of the device (Figure 2).
Regarding claim 36, Suehara further teaches wherein using the drain or the rib (one of 22) includes passively directing, using the rib, the wash solution to the drain (any wash solution hitting 22 will be passively directed to the liquid outlet as claimed).
Regarding claim 37, Suehara further teaches wherein using the drain or rib includes spacing, using the rib (one of 22), the device from the wall of another device (2; Figure 2).
Regarding claim 38, Burt/Barlow further discloses wherein delivering the pressurized gas to generate the atomized spray and delivering the pressurized gas to dry the endoscope is via the same gas channel (the gas is delivered via channel 104 in Burt which would deliver the compressed drying air in the combination with Barlow).
Regarding claim 39, Burt further discloses wherein the wash solution is saline (paragraph [0031].
Regarding claim 40, Burt further discloses wherein the pressurized gas is carbon dioxide (paragraph [0031]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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