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 .
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, 21-23, 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”) and U.S. Publication No. 2010/0198013 (“Binmoeller”).
Regarding Claims 1 and 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);
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.
Regarding Claim 2-4, 6, Banik discloses that the endoscopic procedure may comprise various minimally invasive procedures which remove target tissue from the duct wall of the anatomical cavity while leaving the duct wall intact including snaring of polyps along with more invasive procedures such as endoscopic mucosal resection and full-thickness resection (Par. 52, 87, 113-118).
Regarding Claim 5, Banik, as modified in view of Binmoeller, discloses the surgical procedure further comprises producing an opening in the duct wall (see Par. 52, 87, 113-118 – Banik); and
disinfecting anatomy within the patient with the disinfecting liquid medical instrument comprises applying disinfectant around the opening (see Fig. 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.
Regarding Claim 11, Banik, as modified, provides for dispensing irrigation fluid through the fluid passage when not dispensing disinfecting liquid (Par. 56)
Regarding Claim 17, Banik, as modified by Binmoeller, discloses that disinfectant material may be dispersed onto tissue leading up to the target tissue (see Binmoeller – Fig. 5, 6; Par. 4 which suggests dispensing a disinfectant over a broader region of tissue to ensure efficacy).
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).
Regarding Claim 22, Banik, as modified (see above), provides that disinfectant can be provided either via the irrigation port (116) OR the working channel (120), whereby when the working channel (120) is used it constitutes a second passage with the irrigation fluid port/lumen comprising the first passage which permits dispensing an irrigation fluid connected to a fluid reservoir outside the endoscope.
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). 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, 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.
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.
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, 18, 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”) and U.S. Publication No. 2010/0198013 (“Binmoeller”) as applied above, and further in view of WO 97/43969 (“Edwards”).
Regarding Claim 16, 18, and 24, Banik, as modified, discloses the invention substantially as claimed except that that the system also applies ultraviolet light to the target tissue, including tissue leading up to the target. However, Edwards discloses that internal application of UV light to the mucosa of the alimentary canal can be employed via an optical fiber so as to radiate outward therefrom and provide disinfection of the tissue (Clm. 9, 23). 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 provide disinfecting UV light via an optical fiber radiating the light radially outward from the endoscope, as disclosed by Edwards, in order to provide for multiple methods of affecting disinfection thereby accounting for destruction of pathogens which might be resistant against one form of disinfectant but not the other.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 03/02/2026