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 .
Response to Amendment
The amendments filed on 08/21/2026 have been entered. Claims 1-18 and 21-22 remain pending in the application. The amendments overcome the claim objections set forth in the previous office action dated 05/21/2026.
Claim Objections
Claim 21 is objected to because of the following informalities: In line 2 of claim 21, “prevents fluid ingress” should be changed to “is configured to prevent fluid ingress” because the tubular portion of the tissue shaving instrument is not a positively recited limitation of the claim. Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 08/21/2026, with respect to the rejection(s) of claim(s) 13 in view of Makower have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative interpretation of Tarke. Examiner notes that the arguments pertaining to claim 13 were found to be persuasive because claim 13 positively recites the rotary instrument.
Applicant's arguments, see pages 6-8, regarding the rejections of claim 1 have been fully considered but they are not persuasive. Applicant argues that Tarke fails to teach “a hollow interior being configured to continuously compress against a tubular portion of the tissue shaving instrument and frictionally hold the shaft assembly in a fixed axial position relative to the tubular portion”. Examiner disagrees because [0173] discloses the shaft assembly being configured to receive a tubular portion 1020 of a tissue shaving instrument. However, the tissue shaving instrument is not a positively recited limitation of the claim and therefore the shaft assembly need only be configured for use in the claimed manner. The hollow interior of the shaft is at least sized and shaped so that it could receive a tubular portion having a diameter which would cause frictional engagement and therefore continuous compression therealong. Therefore, applicant’s argument is not persuasive.
Applicant further argues that Makower fails to teach “a hollow interior being configured to continuously compress against a tubular portion of the tissue shaving instrument and frictionally hold the shaft assembly in a fixed axial position relative to the tubular portion” because Makower teaches the inner lumen of the sheath having a lubricious liner to facilitate sliding of devices therethrough. However, it is the examiner’s position that the ability of the shaft assembly to continuously compress against a tubular portion of the tissue shaving instrument and frictionally hold the shaft assembly in a fixed axial position relative to the tubular portion is dependent on the size of the tissue shaving instrument inserted therein. Further, because the tissue shaving instrument is not a positively recited element of the claim, “configured to continuously compress against a tubular portion of the tissue shaving instrument and frictionally hold the shaft assembly in a fixed axial position relative to the tubular portion” is interpreted as functional language reciting an intended use of the device. The lumen of the shaft assembly of Makower is at least configured to be used in the claimed manner because it is at least sized and shaped such that it could receive a tubular portion having a diameter which would cause frictional engagement and therefore continuous compression therealong. Therefore, applicant’s argument is not persuasive.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tarke et al. (US 2022/0257093).
Regarding claim 1, Tarke et al. discloses a flexible adapter (1100, FIG 39-43, [0169]) for use with a tissue shaving instrument (1000, FIG 39-40, [0169]) the flexible adapter comprising: a hub (1110) configured to engage a portion of the tissue shaving instrument ([0174]), in a predetermined angular orientation with respect to an axis of the tissue shaving instrument (Such as in FIG 39); a shaft assembly (1120) extending from the hub and defining a hollow interior (FIG 42) and an open distal end (1122), the hollow interior being configured to continuously compress against a tubular portion of the tissue shaving instrument and frictionally hold the shaft assembly in a fixed axial position relative to the tubular portion ([0173] discloses the shaft assembly being configured to receive a tubular portion 1020 of a tissue shaving instrument. However, the tissue shaving instrument is not a positively recited limitation of the claim and therefore the shaft assembly need only be configured for use in the claimed manner. The hollow interior of the shaft is at least sized and shaped such that it could receive a tubular portion having a diameter which would cause frictional engagement and therefore continuous compression therealong); and a navigation sensor (1146, [0174-0175]) being disposed proximate the open distal end of the shaft assembly (FIG 41), the navigation sensor being configured generate a signal indicating a position of at least a portion of the shaft assembly in three-dimensional space (0174]).
Regarding claim 2, Tarke discloses the navigation sensor comprises a first navigation sensor being disposed on the shaft assembly proximate the distal end (FIG 41, distal most sensor 1146) and a second navigation sensor (1144) being disposed on the shaft assembly in a different position relative to the first navigation sensor (FIG 41, [0175]).
Regarding claim 3, Tarke et al. discloses the shaft assembly comprises a sleeve (1150, FIG 41) configured to flex ([0177] discloses 1150 can be make of a polymeric material and can be bent, malleable, or otherwise flexible) to conform to a size and shape of a portion of the tissue shaving instrument ([0173] discloses 1150 being “closely corresponding” to the diameter of shaft 1020), the navigation sensor being secured to the sleeve (FIG 41-42).
Regarding claim 4, Tarke et al. discloses the sleeve comprises a shaped portion defining the open distal end of the shaft assembly (The body of 1150 shown in FIG 41, which defines the open distal end at 1152/1122 is interpreted as the shaped portion), the shaped portion of the sleeve being configured to apply circumferential compression against a portion of the tissue shaving instrument (1150 is able to flex and be formed of a malleable material, therefore it is at least configured to receive a portion of a tissue shaving instrument in a manner which would result in at least some circumferential compression).
Regarding claim 5, Tarke et al. discloses the navigation sensor is secured to the shaped portion (FIG 41), the shaped portion being configured to compress the navigation sensor secured to the shaped portion into a portion of the tissue shaving instrument (by means of the sensor being attached to 1150 as shown in FIGs 41-42, [0171, 0174-0176]).
Regarding claim 7, Tarke et al. discloses the hub comprises a plurality of receiving features configured to receive a portion of the tissue shaving instrument ([0174] discloses hub 1110 engaging with 1010 of the tissue shaving instrument via snap fit engagement features).
Regarding claim 21, Tarke et al. discloses an interface between the sleeve and the tubular portion of the tissue shaving instrument prevents fluid ingress ([0173] the close correspondence between the sleeve and the tubular portion of the tissue shaving instrument is configured to prevent fluid ingress at least to some degree).
Claim(s) 1, 3-5, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makower (US 2007/0208252).
Regarding claim 1, Makower discloses a flexible adapter (50, FIG 5-5A, [0092]) for use with a tissue shaving instrument ([0092] discloses 50 can have working device 30 inserted therethrough. 30 comprises working element 36, FIG 3, which can include a cutter or debrider, [0079]) the flexible adapter comprising: a hub (54) configured to engage a portion of the tissue shaving instrument (The hub is a Luer hub, [0092], and therefore is at least configured to engage a portion of a tissue shaving instrument. Examiner notes the tissue shaving instrument is not positively recited and therefore can take any shape or form such as a tool having a complementary hub for attachment to the Luer hub 54), in a predetermined angular orientation with respect to an axis of the tissue shaving instrument (The angular orientation of lumen 216 defines what angle the instrument can be received since it must align to fit through the lumen); a shaft assembly (52) extending from the hub and defining a hollow interior (FIG 5A) and an open distal end (Tip at distal end DE. Understood to be open in order to “allow a guidewire 10 and/or working device 30, 40, 60 to be advanced through the lumen 216 of the subselective sheath 50”, [0092]), the hollow interior being configured to continuously compress against a tubular portion of the tissue shaving instrument and frictionally hold the shaft assembly in a fixed axial position relative to the tubular portion (The tissue shaving instrument is not a positively recited limitation of the claim and therefore the shaft assembly need only be configured for use in the claimed manner. The hollow interior of the shaft is at least sized and shaped such that it could receive a tubular portion having a diameter which would cause frictional engagement and therefore continuous compression therealong); and a navigation sensor (16) being disposed proximate the open distal end of the shaft assembly (FIG 5), the navigation sensor being configured generate a signal indicating a position of at least a portion of the shaft assembly in three-dimensional space ([0070, 0092, 0096]).
Regarding claim 3-5, Makower discloses the shaft assembly comprises a sleeve configured to flex to conform to a size and shape of a portion of the tissue shaving instrument [0092] discloses “the tubular body 52 of the subselective sheath 50 may be formed of a polymer such as Pebax, polyimide, high density polyethylene (HDPE), low density polyethylene (LDPE), blends of HDPE/LDPE, etc. and may have a wall thickness from approximately 0.001 inches through approximately 0.050 inches” which is interpreted as being at least configured to flex), the navigation sensor being secured to the sleeve ([0092], FIG 5), wherein the sleeve comprises a shaped portion defining the open distal end of the shaft assembly (The region of the distal end marked DE is interpreted as the shaped portion and it also comprises the open distal end), the shaped portion of the sleeve being configured to apply circumferential compression against a portion of the tissue shaving instrument (The shaped portion has a lumen and is tubular shaped, and therefore is at least configured to apply a circumferential compression against a portion of the tissue shaving instrument if an instrument where inserted therein having a slightly larger diameter such that a frictional engagement occurs) wherein the navigation sensor is secured to the shaped portion (Sensor 16 is attached at the distal region interpreted as the shaped portion, FIG 5), the shaped portion being configured to compress the navigation sensor secured to the shaped portion into a portion of the tissue shaving instrument (Since 16 is attached to and constrained to the distal region of the tubular shaft body, the sensor is configured to be compressed to a portion of a tissue shaving instrument).
Regarding claim 10-11, Makower discloses the hub comprises an alignment member (at least one of the radially protruding flanges of 54, FIG 5), the alignment member being positioned on the hub in a predetermined angular orientation corresponding to a predetermined angular orientation of the navigation sensor (When constructed and assembled, 54 is constrained to sensor 16 and therefore an angular position of the flanges corresponds to an angular position of the sensor), wherein the alignment member comprises an alignment protrusion, the alignment protrusion extending outwardly from an outer surface defined by the hub (The flanges of hub 54 form protrusions extending outwardly form the hub).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 7-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 2007/0208252) in view of Baldwin (US 2019/0125398).
Regarding claims 7-9, and 12, Makower discloses the invention substantially as claimed, as set forth above for claim 1. Makower further discloses the hub defines an alignment protrusion (at least one of the radially protruding flanges of 54, FIG 5).
Makower is silent regarding the hub comprises a plurality of receiving features configured to receive a portion of the tissue shaving instrument (claim 7), wherein each receiving feature defines a slot (claim 8), wherein each slot extends distally from a proximal end of the hub (claim 9), wherein the hub defines an alignment protrusion and a plurality of receiving features, the alignment protrusion being proximate a single receiving feature of the plurality of receiving features (claim 12).
However, Baldwin et al. teaches in the same field of endeavor a hub (103) of an outer shaft (104, FIG 11) which is connectable to a hub (106) of an inner shaft (105), the hub comprises a plurality of receiving features configured to receive a portion of the tissue shaving instrument (FIG 15A and 18A show the slots in between the threads of 103 which are configured to receive and engage the corresponding threads on 106 of the luer connection, [0161]), wherein each receiving feature defines a slot (FIG 18A, the space between the projection of the external treads forms a slot), wherein each slot extends distally from a proximal end of the hub (FIG 18A),
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the luer connections taught by Makower such that the hub comprises a plurality of receiving features configured to receive a portion of the tissue shaving instrument, wherein each receiving feature defines a slot, wherein each slot extends distally from a proximal end of the hub, as taught by Baldwin et al., for the purpose of forming the luer connection in a manner commonly known in the art having a threaded connection for releasable connecting the hubs. In the device as modified, the alignment protrusion is proximate a dingle receiving feature of the plurality of receiving features (because the alignment protrusion is located on the luer hub and the luer hub also comprises the receiving features as modified).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tarke et al. (US 2022/0257093) in view of Jacobsen et al. (US 2010/0234724).
Regarding claim 6, Tarke discloses the invention substantially as claimed, as set forth above for claim 1. Tarke further discloses navigation sensor comprises a second navigation sensor that is integrated into a distal end of the shaft assembly (FIG 41, sensor 1146 is integrated into the distal end of the shaft) and discloses the use of additional navigation sensors at a proximal position ([0175]).
Tarke is silent regarding a first navigation sensor that is integrated into or onto the hub.
However, Jacobsen et al. teaches in the same field of endeavor of instruments for use in an ENT procedure (12, FIG 2A) having a hub (14), a shaft (80) and a sensor positioned on the hub ([0038]) for indicating a position of the device within 3D space ([0038, 0061-0062], FIG 3A).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Tarke to have an additional sensor located on the hub, as taught by Jacobsen, for the purpose of obtaining additional tracking points to dynamically determine the position of the device relative to the patient.
Claim(s) 8, 9, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tarke et al. (US 2022/0257093) in view of Shener-Irmakoglu (US 2019/0110807).
Regarding claims 8, 9, and 22, Tarke discloses the invention substantially as claimed, as set forth above for claim 7.
Tarke is silent regarding each receiving feature defines a slot that extends distally from a proximal end of the hub and wherein a first receiving feature of the plurality of receiving features has a shape or size that is different from a shape or size of each other receiving feature of the plurality of receiving features.
However, Shener-Irmakoglu teaches in the same field of endeavor a snap fit connection between two hubs of a surgical instrument (FIG 2) comprising a plurality of receiving features (109 and 105, [0033-0035]) to receive protrusions (119 and 130), each receiving feature defines a slot that extends distally from a proximal end of the hub (FIG 2, 3, and 5A-5B) and wherein a first receiving feature of the plurality of receiving features has a shape or size that is different from a shape or size of each other receiving feature of the plurality of receiving features (feature 105 has a different shape and size than 109, FIGs 5A-5B).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the snap fit connection between the hubs of Tarke so comprise the particular arrangement of receiving features and protrusions as taught by Shener-Irmakoglu, for the purpose of utilizing a snap-fit connection commonly known in the art for releasably connecting the hub to a portion of the tissue shaving instrument.
Claim(s) 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tarke et al. (US 2022/0257093).
Regarding claim 13, Tarke discloses a navigation assembly for use in an ENT procedure (FIG 39-40), the navigation assembly comprising: a rotary instrument (1000, [0169]; the instrument is rotatable), the rotary instrument comprising a body (102), a rotary hub (1010, 1006, FIG 40) associated with the body (FIG 40), and a shaft (1020) extending from a portion of the body or the rotary hub, wherein the shaft comprises an end effector (1022) proximate a distal end of the shaft (FIG 40), wherein the end effector comprises a rotating feature configured to affect tissue ([0170]); and an adapter(1100, FIG 39-43, [0169]), the adapter comprising: an adapter hub (1110) configured to receive a portion of the rotary hub ([0174]), in a predetermined angular orientation with respect to an axis of the tissue shaving instrument (T Such as in FIG 39); a shaft assembly (1120) extending distally from the adapter hub, the shaft assembly comprising a sleeve (1150) configured to receive the shaft of the rotary instrument within a hollow interior defined by the sleeve ([0173]); and a navigation sensor (1146, [0174-0175]) secured to a portion of the adapter (FIG 41, via mechanical connection) and being configured to generate a signal indicating a position of one or more features of the sleeve in three-dimensional space ([0174]), the navigation sensor being positionable proximate the end effector of the tissue shaving instrument when the shaft of the tissue shaving instrument is received within the sleeve of the adapter (Sensor 1146 is at the distal end of sleeve 1150/1130 and the end effector 1022 is at the distal end of 1020. Therefore, when 1020 is inserted within the lumen of 1150, the sensor will be position proximate to the end effector).
Tarke is silent regarding the sleeve being configured to compress against the shaft of the rotary instrument such that the sleeve resists relative sliding between the sleeve and the shaft of the rotary instrument.
However, Tarke teaches the desire for a close correspondence between the outer diameter of the shaft of the rotary instrument and the inner diameter of the sleeve such that the overall diameter of the device is not substantially increased ([0173] “Inner shaft (1150) defines an inner diameter (ID) that corresponds with the outer diameter of outer shaft (1030) of tissue shaving instrument (1000), such that shaft assembly (1020) may be readily inserted into shaft assembly (1120), with shaft assembly (1120) closely corresponding to shaft assembly (1020). With such close correspondence, shaft assembly (1120) may not substantially add to the outer diameter of shaft assembly (1020), such that the addition of adapter sheath (1100) may not undesirably bulk up the profile of tissue shaving instrument (1000)”).
Although the disclosure does not explicitly state how close of a distance would be considered “close correspondence”, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the correspondence to be a friction fit between the two elements such that the shaft of the rotary instrument is still slidably received within the sleeve while minimizing the overall diameter of the device. Examiner notes that during operation of the rotary instrument, no relative movement between the instrument shaft and the adapter sleeve is required ([0174] discloses the elements are constrained together at their hubs) and therefore the modification would not inhibit the intended operation of the device and would achieve the predictable result of positioning the navigations sensors at predictable position relative to the end effector. In the device as modified, the sleeve resists relative sliding between the sleeve and the shaft of the rotary instrument at least some degree due to the frictional contact and close correspondence therebetween.
Regarding claims 14-16, Tarke discloses the invention substantially as claimed, as set forth above for claim 13. Tarke further discloses the rotary hub (1010) comprises a plurality of locating features, the adapter hub (1110) comprises a plurality of receiving features, wherein the receiving features are complementary to the locating features such that each receiving feature is configured to receive a corresponding locating feature ([0174] discloses ”hub (1110) may provide a snap fit, and interference fit, or any other suitable kind of relationship with hub (1010)”. Having a snap fit means there is at least some locating features on the rotary hub which align and engage with receiving features of the adapter hub), wherein a single receiving feature of the plurality of receiving features is angularly aligned with an angular position of the navigation sensor (because the features are integrally formed on the hub and the hub is connected the shaft which contains the navigation sensor, the sensor and the features are aligned with an angular position because one could use the position of the hub features to determine the location of the sensor). The adapter hub comprises one or more poka-yoke features configured to permit engagement between the rotary hub and the adapter hub in a single predetermined position relative to each other due to the snap fit connection which required proper alignment in order for the hubs to engage.
Regarding claim 17, Tarke discloses the invention substantially as claimed, as set forth above for claim 13. Tarke further discloses the rotary instrument comprises a tissue shaving instrument ([0169-0170]).
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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