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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/18/26 has been entered.
Claim Objections
Claims 21 and 36 are objected to because of the following informalities: limitation “by breaking a cylindriceous portion the navigation sleeve at one of a plurality of longitudinal positions along the navigation sleeve” should be “by breaking a cylindriceous portion of the navigation sleeve at one of a plurality of longitudinal positions along the navigation sleeve”. Appropriate correction is required.
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.
Claims 21-37 and 41-46 are rejected under 35 U.S.C. 103 as being unpatentable over Bertolero et al. (US 2005/0159645), in view of Kowshik et al. (US 2016/0256230), further in view of Okada et al. (US 5,354,518) and Andreasson et al. (US 2019/0025040).
Addressing claims 21 and 36, Bertolero discloses a method of adapting a medical instrument for use with an image guidance system, the method comprising (see [0040]):
inserting a shaft of a medical instrument through a lumen of the navigation sleeve (see Figs. 1, 4A-6B, [0010] and [0033]; sheath/sleeve 10, 50, 60 and 80; shaft 100);
inserting the distal end of the shaft into an anatomical passageway (see [0010] and [0042]; insert medical device (endoscope/catheter) into the patient; obvious to one of ordinary skill in the art that catheter/endoscope is inserted into the patient through anatomical passageway or small incision);
inserting a shaft of a medical instrument through a lumen of the first portion of the navigation sleeve (see Figs. 1, 4A-5A, [0010] and [0033]; sheath/sleeve 10, 50 and 60; shaft 100);
inserting the distal end of the shaft into an anatomical passageway (see [0002], [0039] and [0061]);
comparing a first effective length of a navigation sleeve to a second effective length of the medical instrument; comparing relative sizes of the navigation sleeve and the medical instrument; shortening the navigation sleeve from the first effective length to the second effective length or separating a first portion of the navigation sleeve from a second portion of the navigation sleeve based on the comparing by breaking a cylindriceous portion the navigation sleeve at one of a plurality of longitudinal positions along the navigation sleeve, sliding the navigation sleeve proximally over a shaft of the medical instrument (see [0034] and Figs. 6A-B; the specification does not disclose comparing language; examiner interprets the claim limitation according to paragraph [0040]; basically shorten the sleeve so that it could use for many devices; shorten the sleeve so that it fit the device the operator wants to use; obvious that the operator compare the sleeve to the device the operator intended to use and then shorten the sleeve to fit this device/scope; Bertolero discloses the same concept of sheath/sleeve to fit a particular scope or a particular procedure; sliding the navigation sleeve/sheath over the shaft or insert the shaft into sleeve/sheath is disclose by Figs. 6A-B; “sheath 80 including a longitudinal fold 82 or lumen” and “the sheath 80 shown also includes frangible zones 84 that create break lines allowing the sheath 80 to be shortened to fit a particular scope or a particular procedure”; sheath 80 is form by folding into a lumen 82 therefore it is cylindrical in shape and could be shorten by breaking at mark 84). Sliding the navigation sleeve proximally over a shaft of the medical device before or after shorten sleeve is obvious in the absence of new or unexpected results. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
Bertolero does not disclose inserting the shaft of the medical instrument to the navigation sleeve such that an end effector at a distal end of the shaft is positioned at a distance relative to a navigation element of the navigation sleeve; using an image guidance system to determine the location of the end effector in the patient, based on signals from the navigation element, while the distal end of the shaft is within the anatomical passageway; tightly fit or securely fit the sheath/sleeve to the shaft; inserting the distal end of the shaft into an anatomical passageway of an ear, nose, or throat of a patient and securing the shaft to the navigation sleeve such that an end effector is positioned at a fixed distance relative to a navigation element of the navigation sleeve. Kowshik discloses inserting the shaft of the medical instrument to the navigation sleeve such that an end effector at a distal end of the shaft is positioned at a distance relative to a navigation element of the navigation sleeve; using an image guidance system to determine the location of the end effector in the patient, based on signals from the navigation element, while the distal end of the shaft is within the anatomical passageway (see Fig. 2, [0002], [0028], [0031-0033], [0044]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bertolero to insert the shaft of the medical instrument to the navigation sleeve such that an end effector at a distal end of the shaft is positioned at a distance relative to a navigation element of the navigation sleeve; using an image guidance system to determine the location of the end effector in the patient, based on signals from the navigation element, while the distal end of the shaft is within the anatomical passageway as taught by Kowshik because this allow operator to treat tissue with end effector and visualize the treatment in the same device (see [0028]; grasp tissue with end effector).
Bertolero discloses fitted the sheath over the endoscope, but does not explicitly disclose if it is tightly or securely fit the sheath to the endoscope. Okada discloses tightly fit or securely fit the sheath/sleeve to the shaft (see col. 1, line 65-col. 2, line 8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bertolero to have the shaft securely fit the catheter/sleeve as taught by Okada because this would tightly fit the shaft within an internal lumen of the catheter (see abstract). Bertolero in view of Kowshik and Okada tightly or securely fit the shaft to the sheath/sleeve and this enable the end effector at the end of the shaft to positioned at a fixed distance relative to a navigation element of the navigation sleeve.
Andreasson discloses inserting the distal end of the medical instrument into an anatomical passageway of an ear, nose, or throat of a patient (see [203-0204]; Andreasson inserts the device into ear; Bertolero discloses the medical instrument has a shaft (shaft is part of endoscope)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bertolero to insert the distal end of the medical instrument into an anatomical passageway of an ear, nose, or throat of a patient as taught by Andreasson because this help and implant treatment of the ear (see [0203-0204]). Andreasson provided a treatment of another body part.
Addressing claims 22-28 and 37, Bertolero discloses:
regarding claim 22, shortening the navigation sleeve comprising cutting the navigation sleeve (see [0034]).
regarding claim 23, shortening the navigation sleeve comprising cutting the navigation sleeve based on a set of indicia spaced apart along the navigation sleeve (see Figs. 6A-B and [0034]).
regarding claim 24, shortening the navigation sleeve comprising breaking away one or more frangible segments of the navigation sleeve (see [0034]).
regarding claim 25, the one or more frangible segments being defined by longitudinally spaced apart weakened annular regions of the navigation sleeve (see [0034]; break line 84 is the weaken region).
regarding claim 26, the longitudinally spaced apart weakened annular regions including longitudinally spaced apart annular perforations (see [0034] and Figs. 6A-B).
regarding claim 27, shortening the navigation sleeve comprising longitudinally deforming the navigation sleeve (see [0034]; deform is to alter the shape of by stress; cutting is equivalent to deform; any technique to shorten device is equivalent to cutting to shorten device and obvious to one of ordinary skill in the art).
regarding claim 28, shortening the navigation sleeve comprising crumpling the navigation sleeve (Bertolero does not disclose crumpling the navigation sleeve; however, shorten the instrument by cutting or crumpling is equivalent alternative and only require routine skill in the art; any technique to shorten device is equivalent to cutting to shorten device and obvious to one of ordinary skill in the art).
regarding claim 37, discarding the second portion of the navigation sleeve (see [0034]; cutting the catheter to shorten it implicitly mean discarding the cut portion of the sheath/sleeve).
Addressing claims 29-32 and 42, Okada discloses:
regarding claim 29, inserting the shaft of the medical instrument through the lumen of the navigation sleeve comprising expanding the navigation sleeve radially outwardly, and securing the shaft of the medical instrument to the navigation sleeve comprising resiliently contracting the navigation sleeve radially inwardly to frictionally engage the shaft (see col. 1, line 65-col. 2, line 8; examiner interprets as contracting the navigation sleeve radially inwardly to frictionally engage the shaft; as see in applicant publication paragraph [0038]; there are two ways the sleeve frictionally engage the shaft; there is no reason to expand the sleeve to insert the shaft when the sleeve shrink to frictionally engage the shaft; expand the sleeve is a different way from contracting the sleeve; they are equivalent ways to have the sleeve frictionally engage the shaft; using any way is obvious to one of ordinary skill in the art).
regarding claim 30, securing the shaft of the medical instrument to the navigation sleeve comprising shrinking the navigation sleeve radially inwardly to adhere to the shaft in response to a condition (see col. 1, line 65-col. 2, line 8).
regarding claims 31-32, the condition including moisture or applied voltage (Okada disclose shrinking sleeve by thermal/heating; shrinking sleeve by moisture or applied voltage are just equivalent ways that obvious to one of ordinary skill in the art and only require routine skill in the art; see applicant’s publication specification paragraph [0038]; there numerous equivalent ways to shrink sleeve such as heating, moisture or applied voltage).
regarding claim 42, wherein the step of securing the shaft of the medical instrument to the navigation sleeve comprises positioning a protective structure about an exterior of the navigation element, the protective structure selected from the group consisting of an outer tube, an outer sleeve, an overmold, and a shrink wrap (see col. 1, line 65-col. 2, line 8; Okada does not disclose securing the shaft of the medical instrument to the navigation sleeve by using protective structure such as shrink wrap; Okada discloses securing the shaft of the medical instrument to the navigation sleeve comprising shrinking the navigation sleeve radially inwardly to adhere to the shaft; however, as see in applicant’s paragraph [0029], [0038] and claim 30; there are many versions or method to secure the shaft of the medical instrument to the navigation sleeve that only require routine skill in the art and does not change the operation principle (In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)).
Addressing claims 33-35, 41 and 43-46, Kowshik discloses:
regarding claim 33, the image guidance system including a processor, the method further comprising informing the processor of the fixed distance (see Figs. 1-2, [0026-0039] and [0044]; image is use to monitor treatment site; end effector 226 is protruded from catheter body 216 from lumen 225 at fix distance to grasp tissue; input 104 provide processor with instruction to move end effector to a fixed distance from catheter distal end 216 using motor).
regarding claim 34, informing the processor of the fixed distance comprising using operating controls of the image guidance system to input the fixed distance to the processor (see Figs. 1-2, [0026-0039] and [0044]; image is use to monitor treatment site; end effector 226 is protruded from catheter 216 from lumen 225 to move and grasp tissue; input 104 provide processor with instruction to move end effector to a fixed distance from catheter distal end 216 using motor).
regarding claim 35, informing the processor of the fixed distance comprising measuring and calibrating the fixed distance via an electromagnetic calibration system (Kowshik does not disclose measure and calibrate to automatically have end effector at a fixed distance from the navigation element of the navigation sleeve; however, measure and calibration to have end effector at a fixed distance from the navigation element of the navigation sleeve is an equivalent alternative to user input that only require routine skill in the art; as see in applicant’s specification paragraphs [0036]; these alternatives apparent and obvious to those of ordinary skill in the art; using measure and calibrate to automatically have end effector at a fixed distance from the navigation element of the navigation sleeve instead of user manually input is obvious to one of ordinary skill in the art; In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined “old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed.” The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.).
regarding claim 41, using the image guidance system to determine the location of the end effector in the patient, based on signals from a plurality of navigation elements spaced along the navigation sleeve (see [0029-0030], [0037] and [0046]; sensor sensing location of tip/end effector then system generate image to track is the same as image guidance system determine the location of the end effector in the patient, based on signals from a plurality of navigation elements; one or more magnetic coils is plurality of navigation elements spaced along the navigation sleeve).
regarding claim 43, wherein the navigation element comprises a coil wrapped about a longitudinal axis of a body of the navigation sleeve (see [0046] and Fig. 2; EM sensor coil wrap about the sleeve).
regarding claim 44, wherein the coil is positioned on an outer surface of the body, within a wall of the body, or on an inner surface of the body (see Fig. 2 and [0046]).
regarding claim 45, wherein the navigation element comprises a wire positioned and secured along an outer surface of a body of the navigation sleeve (see Fig. 4 and [0056]; Kowshik does not disclose secure wire along an outer surface of a body of the sleeve; however, Kowshik discloses having wire the lumen embedded in the sleeve; any way of arrangement only require routine skill in the art and does not change the operation principle (In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)); as see in applicant’s specification paragraphs [0031-0033] and Figs. 3-4 there are many alternative to arrange the wire).
regarding claim 46, wherein the wire is secured to the outer surface by a longitudinally extending channel formed in the outer surface or by shrink wrap (see Fig. 4 and [0056]; Kowshik does not disclose secure wire along an outer surface of a body of the sleeve by shrink wrap or fitted in a longitudinally extending channel or recess formed in outer surface; however, Kowshik discloses having wire the lumen embedded in the sleeve; any way of arrangement only require routine skill in the art and does not change the operation principle (In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)); as see in applicant’s specification paragraphs [0031-0033] and Figs. 3-4 there are many alternative to arrange the wire).
Response to Arguments
Applicant's arguments filed 02/19/26 have been fully considered but they are not persuasive. Applicant argues none of the other cited references teaches or otherwise suggests “shortening the navigation sleeve from the first effective length to the second effective length by breaking a cylindriceous portion the navigation sleeve at one of a plurality of longitudinal positions along the navigation sleeve,” as recited in Claims 21 and 36. Applicant argues the only "frangible sheath" taught in Bertolero fails to teach a breakable "cylindriceous portion of a navigation sleeve," as recited in the present claims. Applicant’s argument is not persuasive because “sheath 80 including a longitudinal fold 82 or lumen” and “the sheath 80 shown also includes frangible zones 84 that create break lines allowing the sheath 80 to be shortened to fit a particular scope or a particular procedure”; sheath 80 is form by folding into a lumen 82 therefore it is cylindrical in shape and could be shorten by breaking at mark 84 therefore that is breakable “cylindriceous portion of a navigation sleeve”. 84 is the break line for cylindrical lumen 82. Applicant argues Bertolero does not teach shortening the sheath by removing radiopaque markers from the sheath. Applicant’s argument is not persuasive because the claims do not have this limitation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2008/0093414 (see abstract and claim 14; catheter with end effector); US 2003/0191478 (see [0084]; endoscope with end effector); US 2003/0125731 (see abstract; endoscope with end effector); US 12,256,923 (see Fig. 3, catheter with end effector) and US 2010/0056900 (see [0187] and 5A; plurality of tracking coils 170a along the longitudinal axis of device determine location with respect to imager).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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