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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04 May 2026 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.
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) 1-6, 9, 11, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0199052 (“Banik”) in view of U.S. Publication No. 2008/0183035 (“Vakharia”) and U.S. Publication No. 2010/0198013 (“Binmoeller”).
Regarding Claim 1, Banik discloses a method for performing a surgical procedure (see e.g. Par. 52, 87, 113-118 – e.g. polypectomies, endoscopic mucosal resections, and full-thickness resections), comprising:
inserting an elongate working shaft (see Fig. 1A) of an endoscope (20) into a first opening in anatomy of a patient (e.g. the mouth, anus, vagina – see Par. 2) to reach target tissue within an anatomical cavity (e.g. a target portion of the GI tract or uterus);
inserting a medical instrument (e.g. snares, forceps…etc. – Par. 52) into a working channel (120) of the endoscope to reach the target tissue within the anatomical cavity (Par. 2, 52); and
performing treatment of the target tissue with the medical instrument (Par. 52, 87, 113-118).
Banik discloses the invention substantially as claimed except that that the method further comprises disinfecting anatomy within the patient with a disinfecting liquid which is routed through a fluid passage within the endoscope. Banik does disclose that the endoscope may have a fluid passage (inter alia 122 – inclusive to the internal lumen/tubing of the endoscope shaft), but only explicitly recites that this fluid passage is used for “irrigation” for cleaning the image sensor and body cavity anatomy (Par. 56, 65). No mention is made as to the use of a “disinfecting liquid”.
However, Vakharia discloses a related endoscope (130) which also has a lumen (116) for conveying fluids, wherein the lumen can explicitly be used for receiving surgical materials, irrigating fluids, antiseptic agents, or organic substances, etc. therethrough, in addition to or instead of tools” (Par. 35). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to use either the irrigation lumen/port (122) AND/OR the working channel (120) of the endoscope of Banik to deliver an antiseptic agent/disinfecting agent, as disclosed by Vakharia, in order to utilize the lumens for an established function permitting the delivery of an antiseptic/disinfectant as is known in the art.
Specifically, Binmoeller discloses that during endoscopic procedures (Abstract) it is known to be useful to deliver a disinfecting liquid (300) to disinfect both tools (200 – see Fig. 4) and anatomical tissues (100; Fig. 5) to reduce the risk of infection (Par. 4, 7, , 8, and 27-29). While Binmoeller discloses that this is performed with an ancillary tool (10) the disclosure of Vakharia establishes that it is known to be useful to deliver such agents via the irrigation or working lumens of the endoscope itself. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to dispense a disinfecting fluid in the endoscopic method of Banik, as disclosed by Vakharia, in order to allow for disinfection of the surgical tools and tissue site, as disclosed by Binmoeller, to thereby reduce the risk of infection of patient tissue incident to the procedure without necessitating the inclusion of an additional dedicated disinfecting tool.
With respect to the limitation of disinfecting “anatomy between the first opening and the target tissue”, Binmoeller discloses that “a larger area surrounding the surgical site may also be sprayed to further insure that the site is disinfected” (Par. 28) inclusive to the “hundreds of folds of tissue along the convoluted surfaces” of the GI tract (Par. 4) and therefore clearly obviates disinfecting anatomy beyond the target tissue (e.g. in the case of modified Banik the polyp, sample, mucosa…etc. to be removed). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to disinfect a “larger area surrounding the surgical site” in practice of the modified method of Banik, as disclosed by Binmoeller, in order to ensure that suitable margins surrounding the tissue to be excised is disinfected to thereby help prevent the spread of infection. Examiner submits that the phrase “larger area surrounding the surgical site” obviates the disinfecting of anatomical tissue lying both proximally (re: between the first opening and the target tissue) and distally (re: beyond the target tissue further remote from the point of insertion) of the target tissue. Examiner submits that the size and extent of the “larger area surrounding the surgical site” is an obvious design choice based upon physician preference in optimizing a result effective variable established by the prior art (i.e. tissue disinfection margins) to obtain a predictable and expected outcome (i.e. ensuring that infection does not occur).
Here, the method does not particularly specify the extent of the anatomy “between the first opening and the target tissue” disinfected and to what degree this section of the anatomy is remote from the target tissue (e.g. the tissue which is to be penetrated/cut/removed). As such, the claim limitation is not recited with sufficient specificity as to define and distinguish over the “larger area surrounding the surgical site” recited by Binmoeller which would be understood to include anatomy located some indefinite distance leading to the incision site/target.
Regarding Claim 2, as discussed above, Banik discloses that the treatment performed may include various procedures removing the target tissue from a duct wall of the anatomical cavity using a tissue removal device comprising the medical instrument (Par. 52, 87, 113-118).
Regarding Claim 3, as discussed above, Banik discloses removing tissue from the duct wall of the anatomical cavity can be performed in a minimally invasive manner leaving the duct wall generally intact (Par. 52, 87, 113-118 – e.g. a polypectomy using a snare).
Regarding Claims 4 and 6, as discussed above, Banik discloses the surgical procedure may comprise any of a polypectomy, EMR, or full-thickness resection (Par. 52, 87, 113-118).
Regarding Claim 5, Banik discloses the surgical procedure further comprises producing a second opening (i.e. an incision made during tissue resection and/or a biopsy – see Par. 52, 87, 113-118) in the duct wall proximate the target tissue and, as modified in view of Bimmoeller includes disinfecting anatomy within the patient with the disinfecting liquid by applying disinfectant around the incision site (see Fig. 5, 6 – Binmoeller).
Regarding Claim 9, Banik, as modified in view of Vakharia, discloses dispensing the disinfecting liquid disinfectant material onto the target tissue comprises using native fluid dispensing capabilities of the medical instrument endoscope to dispense the disinfecting liquid the disinfectant material via an internal irrigation passage of the endoscope that comprises the fluid passage (see lumens/ports 122, 120, Banik and Par. 35, Vakharia); and
inserting the medical instrument into the endoscope to reach the target tissue within the anatomical cavity comprises inserting the medical instrument into a working channel (120 - Banik) of the endoscope separate from the fluid passage (122 - Banik);
wherein the medical instrument can be inserted into the working channel simultaneously with the disinfecting liquid being dispensed from the fluid passage.
Banik, as modified by Vakharia, discloses that disinfectant can be provided via the internal irrigation passage (Par. 35) instead of or in addition to use of the working lumen, such that in modified Banik it is clearly established that the irrigation lumen (122) can be used (Par. 56), alternatively, for either irrigation or disinfecting while the working lumen is occupied by a medical instrument.
Regarding Claim 11, Banik discloses that the medical instrument can be inserted into the working channel of the endoscope to reach the target tissue within the anatomical cavity, wherein the working channel (20, 120) is a dedicated lumen separate from fluid passage(s) – e.g. (irrigation lumen 122 – see Fig. 6). Banik discloses that irrigant may be dispensed onto the target tissue using an irrigation channel (122) in the endoscope (Par. 73). Banik, as modified, discloses the invention substantially as claimed except that disinfecting liquid is dispensed using a disinfectant channel in the endoscope, the fluid passage of the disinfectant channel being separate and distinct from the irrigation channel.
However, Banik discloses that if desired additional lumens may be included in the endoscope (Par. 56). Likewise, Vakharia discloses that “any number of additional lumens” can be provided in the endoscope (Par. 26) and that any lumen can be used to provide disinfecting solution (Par. 35). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to include an additional lumen in the endoscope of Banik, as suggested by Banik and Vakharia, and utilize this additional lumen to dispense a disinfectant in order to maintain dedicated usage of the instrument lumen and irrigation lumen for performing those functions. It has been held that duplicating the working parts of an invention is an obvious design choice, particularly where directed by the prior art, when utilizing the duplicated components to achieve a predictable and expected outcome, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Here, the prior art suggests adding additional lumens for any suitable purpose and the prior art establishes that antiseptic agents can be dispensed through any lumen, thereby clearly obviated the construction of an additional, dedicated antiseptic/disinfectant channel lumen.
Regarding Claim 17, Banik, as modified by Binmoeller, suggests that the application of disinfecting material onto tissue (inclusive to the surrounding tissue) may be performed contemporaneously with insertion of the elongate working shaft of the endoscope device into the anatomy (see Fig. 5, Binmoeller – i.e. dispensing of the disinfectant occurs during insertion prior to intervention). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide dispensing of the disinfectant of modified Banik during the insertion procedure as the device is being directed toward the insertion site, as disclosed by Binmoeller, in order to achieve the effect of sterilizing a larger surrounding area about the target tissue to thereby better prevent infection by ensuring that a sufficiently large margin of tissue is disinfected remote to the insertion site.
Regarding Claim 18, Banik, as modified, disclose that the working channel, the irrigation channel, and the disinfectant channel (added in view of Vakharia) exit a distal face of the endoscope (see Fig. 6 – Banik), the endoscope further including an imaging sensor (116 – Par. 70) located at the distal end face (Fig. 6) for viewing distally of the endoscope such that imaging from the imaging sensor can be used to view dispensing of the disinfecting liquid (see Fig. 6 with consideration as to modifications to include an additional lumen and port in addition to the irrigation lumen/port and working channel lumen/port in Banik).
Regarding Claim 19, Banik, as modified by Binmoeller, discloses that the medical instruments themselves can be exposed to a disinfectant to coat the instruments by applying the disinfectant within the working channel, whereafter the instruments are introduced into apposition with the patient tissue thereby rubbing the coated disinfectant against the tissue (see Binmoeller – Fig. 4, 6, i.e. the fluid 300 coats the needle which then is advanced from the working channel and contacts/rubs the patient tissue).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0199052 (“Banik”) in view of U.S. Publication No. 2008/0183035 (“Vakharia”) and U.S. Publication No. 2010/0198013 (“Binmoeller”) as applied above, and further in view of U.S. Publication No. 2010/0168637 (“Casey”).
Regarding Claim 10, Banik, as modified, discloses the invention substantially as claimed except that method comprises adding a disinfectant packet to the external fluid reservoir (re: the irrigating liquid source of Banik _ Par. 46) connected to the fluid passage (see at 122). However, Casey discloses antiseptic/disinfectant solutions can be provided for use by a clinician within a packet so as to be dispensed via the appropriate fluid delivery hardware to the patient (Par. 6-9). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the disinfectant solution of modified Banik to the clinician in a packet, as disclosed by Casey, so that the solution may be hermetically stored prior to use for addition to the fluid source reservoir of Banik, as needed during the procedure to permit disinfection of the patient tissue.
Claim(s) 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0199052 (“Banik”) in view of U.S. Publication No. 2008/0183035 (“Vakharia”) and U.S. Publication No. 2010/0198013 (“Binmoeller”) as applied above, and further in view of U.S. Publication No. 2022/0233437 (“Borody”).
Regarding Claim 13, Banik, as modified, discloses the invention substantially as claimed except that that the liquid disinfectant material comprises Povidone-iodine (PVP-I) or Hypochlorous acid (HOCI). However, Borody discloses that PVP-I solutions are known to be useful for disinfecting tissues of the GI tract (Par. 27, 28). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the system of modified Banik to dispense PVP-I liquid solution, as disclosed by Borody, in order to select a well-known antiseptic/disinfectant solution recognized by the prior art for its safety and efficacy when used internally within the GI tract in an expected and predictable manner.
Regarding Claim 20, Banik, as modified discloses the invention substantially as claimed except that that the method further comprises dispensing a microbiome onto the anatomy. However, Borody discloses that after disinfecting of the gut has occurred it is often useful to repopulate the microbiome (Par. 1, 27). It would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the method of Banik to include dispensing a microbiome to the anatomy, as disclosed by Borody, in order to replace any of the beneficial gut bacteria that may have been incidentally destroyed during the procedure to thereby help ensure optimal digestion and processing of nutrients after the procedure.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0199052 (“Banik”) in view of U.S. Publication No. 2008/0183035 (“Vakharia”) and U.S. Publication No. 2010/0198013 (“Binmoeller”) as applied above, and further in view of WO 2010/132429 (“Arcand”) and CN 106308727 (“Cong”).
Regarding Claim 16, Banik, as modified, discloses the invention substantially as claimed except that the method further comprises applying ultraviolet light to the target tissue by directing ultraviolet light radially outward from the endoscope. However, Arcand discloses a related interventional, medical device which utilizes UV light to sterilize internal body tissue surrounding the medical device by emitting UV light radially outward from the body of the device to reduce the risk of infection incident to the insertion of the device within the body lumen (see at 230 – e.g. Fig. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Banik with a UV emitting optical fiber to emit UV light radially outward from the surface of the endoscope device inclusive to the distal end at the target tissue, as disclosed by Arcand, in order to provide for sterilization of the body tissue to help prevent the incidence of infection due to intervention. Cong establishes that the usage of such UV light based sterilization will be have predictable and expected utility when paired in an endoscope (Abstract).
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0199052 (“Banik”) in view of U.S. Publication No. 2008/0183035 (“Vakharia”), U.S. Publication No. 2010/0198013 (“Binmoeller”), and JPH05-297289 (“Ito”)
Regarding Claim 21, Banik discloses a method of performing a surgical procedure (e.g. Par. 87, 113-118), the method comprising:
inserting an elongate working shaft (see Fig. 1A) of an endoscope (20) into anatomy of a patient to reach target tissue within an anatomical cavity (Par. 3, 45);
viewing anatomy using an imaging sensor (116 – Par. 70) of the endoscope to view distally of the elongate working shaft (see Fig. 6 – i.e. the imaging sensor is provided on the distal face of the endoscope viewing distally away from the shaft of the endoscope)
inserting a medical instrument (e.g. snare, forceps…etc. – Par. 52) into the endoscope to reach the target tissue within the anatomical cavity; and
performing treatment of the target tissue with the medical instrument (Par. 52, 87, 113-118).
Banik discloses the invention substantially as claimed except that that the method further comprises disinfecting anatomy within the patient with a disinfecting liquid which is routed through a fluid passage within the endoscope. Banik does disclose that the endoscope may have a fluid passage (inter alia 122 – inclusive to the internal lumen/tubing of the endoscope shaft), but only explicitly recites that this fluid passage is used for “irrigation” for cleaning the image sensor and body cavity anatomy (Par. 56, 65). No mention is made as to the use of a “disinfecting liquid”.
However, Vakharia discloses a related endoscope (130) which also has a lumen (116) for conveying fluids, wherein the lumen can explicitly be used for receiving surgical materials, irrigating fluids, antiseptic agents, or organic substances, etc. therethrough, in addition to or instead of tools” (Par. 35). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to use either the irrigation lumen/port (122) AND/OR the working channel (120) of the endoscope of Banik to deliver an antiseptic agent/disinfecting agent, as disclosed by Vakharia, in order to utilize the lumens for an established function permitting the delivery of an antiseptic/disinfectant as is known in the art.
Specifically, Binmoeller discloses that during endoscopic procedures (Abstract) it is known to be useful to deliver a disinfecting liquid (300) to disinfect both tools (200 – see Fig. 4) and anatomical tissues (100; Fig. 5) to reduce the risk of infection (Par. 4, 7, , 8, and 27-29). While Binmoeller discloses that this is performed with an ancillary tool (10) the disclosure of Vakharia establishes that it is known to be useful to deliver such agents via the irrigation or working lumens of the endoscope itself. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to dispense a disinfecting fluid in the endoscopic method of Banik, as disclosed by Vakharia, in order to allow for disinfection of the surgical tools and tissue site, as disclosed by Binmoeller, to thereby reduce the risk of infection of patient tissue incident to the procedure.
Banik, as modified, discloses the invention substantially as claimed except that the emitting of disinfecting liquid occurs “simultaneously” with a user viewing the dispensing of the disinfecting liquid. While the modified system of Banik is certainly capable of such a utility (the liquid dispensing ports of the irrigating channel and the working channel also facing the distal direction), no explicit direction to utilize the device in such a manner is recited. However, Ito discloses that an endoscope can be used to provide observation explicitly while the dispensing of drugs occurs to a tissue site (see Abstract; Par. 3-7). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the imaging function of the endoscope while dispensing the disinfectant of modified Banik, as disclosed by Ito, in order to allow a user to confirm that the disinfectant is being dispensed correctly to the target surface area in order to ensure efficacious results.
Regarding Claim 22, Banik discloses a first passage (122) within the endoscope can be used to dispense an irrigation fluid connected to a fluids reservoir outside the endoscope (Fig. 3A; Par. 56);
A working channel (120) may be provided as a separate, dedicated passage for simultaneously permitting receipt of instruments (Par. 2, 52, 117).
Banik, as modified, discloses the invention substantially as claimed except that disinfecting liquid is dispensed using a disinfectant channel in the endoscope, the fluid passage of the disinfectant channel being separate and distinct from the irrigation channel.
However, Banik discloses that if desired additional lumens may be included in the endoscope (Par. 56). Likewise, Vakharia discloses that “any number of additional lumens” can be provided in the endoscope (Par. 26) and that any lumen can be used to provide disinfecting solution (Par. 35). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to include an additional lumen in the endoscope of Banik, as suggested by Banik and Vakharia, and utilize this additional lumen to dispense a disinfectant in order to maintain dedicated usage of the instrument lumen and irrigation lumen for performing those functions. It has been held that duplicating the working parts of an invention is an obvious design choice, particularly where directed by the prior art, when utilizing the duplicated components to achieve a predictable and expected outcome, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Here, the prior art suggests adding additional lumens for any suitable purpose and the prior art establishes that antiseptic agents can be dispensed through any lumen, thereby clearly obviated the construction of an additional, dedicated antiseptic/disinfectant channel lumen.
Regarding Claim 23, Banik, as modified discloses the invention substantially as claimed except that that the tube which dispenses the disinfecting fluid is extended “along an exterior” of the endoscope working shaft. However, Vakharia discloses that endoscopes can be provided with accessory lumens/tubes (111) extended along an exterior of the endoscope working shaft wherein the accessory lumen/tube can be used to dispense antiseptic agents (Par. 35) with the tube being secured to the endoscope shaft at a plurality of attachment points spaced along a length thereof (see track 134 which extends along the length of the endoscope). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Banik to include an accessory channel/lumen/tube extended along an exterior of the working shaft of the endoscope using a longitudinally provided track which permits attachment along the longitudinal length of the shaft, as disclosed by Vakharia, to use the accessory channel to advance additional instruments and disinfectant agents as needed thereby allowing the native channels of the endoscope to be committed to other uses.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0199052 (“Banik”) in view of U.S. Publication No. 2008/0183035 (“Vakharia”), U.S. Publication No. 2010/0198013 (“Binmoeller”), and JPH05-297289 (“Ito”) as applied above, and further in view of WO 2010/132429 (“Arcand”) and CN 106308727 (“Cong”)
Regarding Claim 24, Banik, as modified, discloses the invention substantially as claimed except that the method further comprises applying ultraviolet light to the target tissue by directing ultraviolet light radially outward from the endoscope. However, Arcand discloses a related interventional, medical device which utilizes UV light to sterilize internal body tissue surrounding the medical device by emitting UV light radially outward from the body of the device to reduce the risk of infection incident to the insertion of the device within the body lumen (see at 230 – e.g. Fig. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Banik with a UV emitting optical fiber to emit UV light radially outward from the surface of the endoscope device inclusive to the distal end at the target tissue, as disclosed by Arcand, in order to provide for sterilization of the body tissue to help prevent the incidence of infection due to intervention. Cong establishes that the usage of such UV light based sterilization will be have predictable and expected utility when paired in an endoscope (Abstract).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0199052 (“Banik”) in view of U.S. Publication No. 2008/0183035 (“Vakharia”), U.S. Publication No. 2010/0198013 (“Binmoeller”), and JPH05-297289 (“Ito”) as applied above, and further in view of U.S. Publication No. 2006/0173244 (“Boulais”) and U.S. Patent No. 8,881,752 (“Fonteyn”)
Regarding Claim 25, Banik, as modified by Binmoeller, discloses that the disinfecting solution can be distributed to the target tissue via spraying (Par. 28), wherein Banik provides the irrigation tubing (which would have been obvious to use to convey the liquid disinfectant) to comprise and adjustable spray nozzle attached to its distal end (see 124 – Par. 73) in order to assist in directing the spray from the nozzle, which would have been understood to have been useful for directing the fluid to provide a more targeted application to an area of tissue surrounding the distal end of the endoscope.
Banik, as modified, discloses the invention substantially as claimed except that adjusting the spray nozzle includes adjusting between a first spray pattern which dispenses the disinfecting liquid in a concentrated stream over a first distance and a second spray pattern which dispenses the disinfecting fluid in a dispersed pattern over a second distance, shorter than the first distance.
Boulais discloses a related endoscope arrangement likewise configured to provide a spray from the distal end of the device, wherein the distal end may be configured to permit a spray pattern to be selectively adjusted by the user to regulate the spray in a selected pattern (Par. 36). Although Boulais does not explicitly disclose what these patterns may comprise. However, Fonteyn discloses a related adjustable spray device wherein the spray pattern can be altered to select between at least a first pattern which creates a narrower, straight-stream jet (i.e. a first concentrated stream over a first distance) and a wider fan-shaped stream (i.e. a second dispersed stream over a second, shorter distance) (Col. 6, Ln. 32-60). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the device of modified Banik to permit selection between at least two spray patterns, as disclosed by Boulais, including at least a concentrated jet stream and a diffuse fan stream, as disclosed by Fonteyn, in order to permit the user to selectively adjust the distribution pattern of the spray to alter the coverage of the disinfectant.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive or are moot in view of the new ground(s) of rejection or are moot in view of the new ground(s) of rejection.
Applicant argues (Pg. 4) that “Binmoeller’s device positions the disinfecting fluid at the distal tip of the sleeve at the target site, it does not contemplate disinfecting the anatomy leading up to the target tissue along the path of insertion”. However, this is not persuasive. Specifically, Binmoeller expressly suggests that “a larger area surrounding the surgical site may also be sprayed to further insure that the site is disinfected” (Par. 28). As such, Binmoeller expressly contemplates dispensing disinfectant to the tissues surrounding the target site (i.e. the tissue to be treated/cut/penetrated), whereby the ordinary artisan, in affecting this teachings to modified Banik, found have considered the “surrounding” “larger area” to include margins of tissue located both proximally of the treatment site (e.g. the area to be biopsied, the polyp to the removed, the mucosal to be excised…etc.) as well as distally of the treatment site and therefore would have found it obvious to disinfect an indeterminate volume of patient anatomy located leading up to the target tissue and between the endoscopic access point first opening and the treatment site in order to achieve this suggestion of treating a “larger area surrounding the surgical site” in order to better prevent infection by disinfecting ancillary tissue to which infection could spread if not disinfected. Here the area and margins of the treated surrounding tissue are an obvious design choice based upon physician preference and margins of safety for ensuring that the surrounding tissue is sufficiently disinfected.
Applicant argues (Pg. 4) that “Banik contains no disclosure of a passage that alternates between irrigation and disinfectant delivery…” However, Banik is not relied upon for this disclosure, but rather this concept can be found in Vakharia who suggests antiseptics and irrigants can be provided through the same or different lumens. The lumen of modified Banik is configured to provide any suitable fluid including either an irrigant or a disinfectant based upon clinician treatment protocol needs.
Applicant argues (Pg. 5) “Banik discloses at most two functional lumens…” However, this is not persuasive. Banik and Vakharia both contemplate the inclusion of additional lumens such that configurations including at least three lumens, e.g. a working channel, an irrigating lumen, and a disinfecting lumen are obviated (see above).
Applicant argues (Pg. 5) that “Binmoeller contains no disclosure of disinfecting tissue during the dynamic process of inserting or withdrawing the endoscope shaft…” However, this is not persuasive. Specifically, Binmoeller (see Fig. 5) suggests that disinfectant spray can be provided during the insertion procedure while the endoscope is being advanced to provide intervention to the target tissue (see Fig. 6 – note the spatial separation between the two configuration wherein spray occurs at a distance spaced from the target tissue and intervention occurs at a location abutting the target tissue). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the system of Banik to provide disinfectant spray to the “larger area” surrounding the target treatment tissue during the general process of inserting the endoscope prior to reaching the target tissue for intervention in order to ensure that a sufficiently large target area is disinfected to ensure that the interventional procedure does not cause infection of the target and surrounding tissues.
Conclusion
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
08/14/2026
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