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 .
This Office Action is in response to the amendments dated November 21, 2025.
Claims 1-3 and 5-22 are pending.
Claims 9-10 and 12-20 were previously withdrawn as being directed to non-elected inventions.
Claim Objections
Claims 1-3, 5-8, 11, and 21-22 are objected to because of the following informalities: Claim 1 refers to “the plurality of protrusion” instead of “plurality of protrusions” in the last clause. Appropriate correction is required. Claims 2-3, 5-8, 11, and 21-22 are objected to based on their dependency from claim 1.
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 1-3, 5-8, 11, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Karasawa et al. (US 5,575,756) in view of Reever et al. (US 2018/0132703) and Bacich et al. (US 5,279,280).
Regarding Claim 1, Karasawa discloses:
An endoscope, comprising:
a shaft (72) having a center extending axially and including a first end, a second end positioned axially opposite the first end and extending to or through a distal end opening of an access sheath (see Fig. 16 showing 72 extending through sheath 110 to the distal opening), an exterior surface (exterior of sheath) extending between the first end and the second end (the exterior extends between the two ends as shown in Fig. 16), and
wherein said access sheath having a center extending axially and configured to receive at least a portion of the shaft (see Fig. 16 showing the sheath with the endoscope extending therethrough), the access sheath having a proximal end opening opposite said distal end opening (see the opposing open ends), and an inner diameter larger than an outer diameter of the shaft to provide a continuous fluid flow path between the exterior surface of the shaft and the access sheath (see Fig. 17 showing clearance 116), and
wherein each of the plurality of protrusion of the shaft are configured to contact the inner diameter of the access sheath (Karasawa’s protrusion makes contact to create a fluid channel) to improve fluid flow within the continuous fluid flow path (119) and maintain the continuous fluid flow path via a nonconcentric center between the center of the shaft and the center of the access sheath and displacement of the shaft proximate to an interior surface of the access sheath that is axial opposite the plurality of protrusion to decrease resistance of the fluid flow within the continuous fluid flow path (see Fig. 16 and 17(c) showing the protrusions forcing the shaft to be nonconcentric within the sheath).
Karasawa does not explicitly disclose a handpiece releasably coupled to the shaft adjacent the first end; a plurality of protrusions extending from the exterior surface of the shaft, and a plurality of working channels extending axially through the shaft between the first end and the second and adjacent to the exterior surface.
Reever teaches both a proximal port such that the working channel extends the length of the shaft (see Paragraph 0028 and Fig. 3, for example) and a releasable handpiece at the proximal end of the shaft (50 connects shaft 14 to handle 12; see Fig. 3; fixation mechanism is screws, which can be removed to release the handle). These features allow for tools to be inserted to the surgical site from outside the body at the proximal end of the device and for shafts to be replaced as desired, in the event of damage or the need for a different size given the patient or procedure. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Karasawa’s device to include Reever’s full-length working channel and releasable handle. Such a modification incorporates standard features into a known device to yield predictable results. Handles are common as a means to grip the device, and making a separable handle can allow for easy replacement of the shaft or potentially eliminate the need to sterilize the handle following a procedure. Working channels generally extend the length of the shaft so that tools can be inserted into the body from outside the body.
Reever also teaches using a scope having a shaft with a plurality of working channels between the ends adjacent to the exterior surface (see Fig. 2 showing channels 30 and 44). The Examiner also notes that Karasawa discloses embodiments with multiple channels in the endoscope (see Fig. 5, for example). Furthermore, multi-channel endoscopes are old and well-known in the art for delivering tools or fluid, providing suction, and having channels for fiberoptics. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Karasawa’s device to include a plurality of working channels. Such a modification is well-known in the art for guiding tools to the distal end of the device, delivering or removing fluid, and providing a means for visualization components to be inserted to the distal end.
While Karasawa does not explicitly disclose the protrusions extending from the exterior surface of the shaft, Karasawa does disclose the protrusions extending from the interior surface of the access sheath (see Figs. 16 and 17(c)). Bacich is a similar device with an endoscope (11a, 11b, or 11c; see Figs. 7-9) inside a sheath 81 where protrusions on the exterior surface of the scope are configured to create a fluid channel between the scope and the outer sheath via contact with the sheath (Col 7 Lines 56-68). The Examiner asserts that the mere reversal of parts without a change in function would have been obvious to a person having ordinary skill in the art (see MPEP 2144.04.VI.A). Here, a protrusion on the sheath or on the shaft creates the space for fluid to flow between the two. Reversing the configuration does not change this function. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Karasawa’s device to include the protrusion on the shaft as taught by Bacich. Such a modification is the mere reversal of parts without a change in function to yield predictable results and is simply a known alternative means to create a fluid flow path between an inner tubular member and an outer one.
Regarding Claim 2, Karasawa as modified further discloses wherein the plurality of protrusions (Col 14 Lines 47-48) are formed integral with the shaft and create asymmetric spacing between the shaft and the access sheath to promote enhanced flow dynamics (see Figs. 16 and 17(c) showing the asymmetric spacing between the shaft and sheath; Bacich teaches making the protrusions integral with the shaft as discussed above with Claim 1).
Regarding Claim 3, Karasawa as modified further discloses wherein the plurality of protrusions extends radially from the exterior surface of the shaft (see Figs. 16 and 17(c) showing the protrusion extending radially).
Regarding Claim 5, Karasawa as modified further discloses wherein each protrusion of the plurality of protrusions are axially aligned (Col 14 Lines 47-48, for the shaft/sheath configuration to remain when multiple protrusions are included, they need to be axially aligned). The Examiner notes that aligning the protrusions so that the shaft/sheath keep the configuration as shown would have been obvious to a person having ordinary skill in the art so that the device’s function does not change.
Regarding Claim 6, Karasawa as modified further discloses wherein each protrusion of the plurality of protrusions are axially spaced a predetermined distance from an adjacent protrusion (Col 14 Lines 47-48, with multiple protrusions, there is some distance between adjacent protrusions).
Regarding Claim 7, Karasawa as modified does not explicitly disclose wherein each protrusion of the plurality of protrusions is axially spaced between approximately one (1) centimeter (cm) and approximately 10 cm apart from the adjacent protrusion. Applicant has not placed any criticality on the dimension as it is a non-limiting example and “may be” in the range. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Karasawa’s protrusions to be spaced between 1-10 cm apart. Such a modification is the mere change in a dimension without a change in function (see MPEP 2144.04.IV.A citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) and MPEP 2144.05 citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 8, Karasawa as modified further discloses wherein the predetermined distance is based on a length of the shaft. (the distance is based at least in part on the length of the shaft in that, for example, a shaft of 100 cm cannot include multiple protrusions spaced 200 cm apart).
Regarding Claim 11, Karasawa as modified does not explicitly disclose wherein the at least one protrusion includes a height between approximately 0.7 millimeters (mm) and approximately 1.5 mm. However, the height of the protrusions is related to the size of the fluid channel. Taller protrusions provide a larger channel for more fluid flow, but they increase the diameter. Changing the height will not cause Karasawa to operate differently with the claimed height, and a person having ordinary skill in the art would have a reasonable expectation of success as this is simply changing the dimension of the protrusions. Finally, Applicant has not placed any criticality on the dimension as it is a non-limiting example and “may be” in the range. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Karasawa’s protrusions includes a height between approximately 0.1 millimeters (mm) and approximately 1.5 mm. Such a modification is the mere change in a dimension without a change in function (see MPEP 2144.04.IV.A citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) and MPEP 2144.05 citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 21, Karasawa as modified further discloses wherein said endoscope is for insertion into a ureter (intended use and ureteroscopy procedures). The Examiner also notes that the size of an endoscope normally determines its use. As stated above in claim 11, changes in size are considered obvious to allow the scope to be used in the desired anatomical location.
Regarding Claim 22, Karasawa as modified further discloses wherein the continuous fluid flow path reduces intra-pelvic pressure (intended use that does not require a different structure; Karasawa’s device includes the structure and would have the same function if used in the same way).
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.
The Examiner considers the feature obvious in view of Karasawa, but Bacich has also been provided to show that such a configuration is both known and obvious in the art. The application is not in condition for allowance at this time.
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.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795