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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 04/22/2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/22/2026.
Claim Objections
Claim 13 is objected to because of the following informalities: In lines 11, 16, and 17, “the tissue shaving instrument” should be changed to “the rotary instrument”. Appropriate correction is required.
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 is 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 receive a tubular portion of the tissue shaving instrument ([0173]); 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]).
Claim(s) 1, 3-5, 10, 11, 13, and 17 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 receive a tubular portion of the tissue shaving instrument ([0092]); 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).
Regarding claim 13, Makower discloses a navigation assembly for use in an ENT procedure (50, FIG 5, in combination with working device 30, FIG 3, [0079 and 0092]), the navigation assembly comprising: a rotary instrument (30, FIG 3, [0079-0081]; the instrument is rotatable), the rotary instrument comprising a body (32), a rotary hub (38) associated with the body (FIG 3), and a shaft (interpreted to be the distal section of 32 including 36) extending from a portion of the body or the rotary hub, wherein the shaft comprises an end effector (36, [0079]) proximate a distal end of the shaft (FIG 3), wherein the end effector comprises a rotating feature configured to affect tissue ([0079], a cutter or debrider is a rotatable feature configured to affect tissue); and an adapter (50, FIG 5-5A, [0092]), the adapter comprising: an adapter hub (54) configured to receive a portion of the rotary hub (The hub is a Luer hub, [0092], and therefore is at least configured to receive a portion of hub 38 when 30 is inserted into the lumen of 50), 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 distally from the adapter hub, the shaft assembly comprising a sleeve (tubular body, FIG 5A) configured to receive the shaft of the tissue shaving instrument ([0092]) within a hollow interior defined by the sleeve (lumen 216); and a navigation sensor (16) secured to a portion of the adapter (FIG 5) and being configured to generate a signal indicating a position of one or more features of the sleeve in three-dimensional space ([0070, 0092, 0096]), 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 16 is at the distal end of sleeve 52 and the end effector 36 is at the distal end of 32. Therefore, when 32 is inserted within the lumen of 52, the sensor will be position proximate to the end effector).
Regarding claim 17, Makower discloses the rotary instrument comprises a tissue shaving instrument ([0079], a cutter or debrider is a rotatable feature configured to affect tissue and therefore is interpreted as a tissue shaving instrument).
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, 12, and 14-16 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).
Regarding claims 14-16, Makower discloses the invention substantially as claimed, as set forth above for claim 13.
Makower is silent regarding the rotary hub comprises a plurality of locating features, the adapter hub 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 (claim 14), wherein a single receiving feature of the plurality of receiving features is angularly aligned with an angular position of the navigation sensor (claim 15), and wherein 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 (claim 16).
However, Baldwin et a. teaches in the same field of endeavor an adapter hub (103) of an outer shaft (104, FIG 11) which is connectable to a rotary hub (106) of an inner shaft (105), the rotary hub comprises a plurality of locating features (FIG 12-13B show the internal thread ridges), the adapter hub comprises a plurality of receiving features (FIG 15A and 18A show the corresponding slots which receive the thread features of 106), wherein the receiving features are complementary to the locating features such that each receiving feature is configured to receive a corresponding locating feature ([0161], as shown in FIG 9), wherein a single receiving feature of the plurality of receiving features is angularly aligned with an angular position of the distal end of the shaft assembly (the threads and corresponding slots are angled. Because they are mechanically constrained to the shaft, they would also indicate an angular position of the distal end of the shaft), and wherein 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 ([0161], the engagements between the luer connectors are interpreted as a poka-yoke features because the adapter hub can only be received within the rotary hub in one direction).
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 rotary hub comprises a plurality of locating features, the adapter hub 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, wherein a single receiving feature of the plurality of receiving features is angularly aligned with an angular position of the navigation sensor, 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 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 threaded luer engagement.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 2007/0208252) in view of Beeckler et al. (US 2020/0015693).
Regarding claim 2, Makower discloses the invention substantially as claimed, as set forth above for claim 1. Makower further discloses the navigation sensor comprises a first navigation sensor being disposed on the shaft assembly proximate the distal end, (FIG 5, sensor 16 is integrated into the distal end of the shaft).
Makower is silent regarding a second navigation sensor being disposed on the shaft assembly in a different position relative to the first navigation sensor.
However, Beeckler et al. teaches in the same field of endeavor of a catheter (14) having at first and second positioning sensor (at least two of 120, 128, 138, 140, [0042], FIG 2) located at the distal end of the shaft of the catheter (FIG 6-7) at different positions (radially around the shaft) for indicating navigational positioning of the instrument ([0037, 0037-0039 and 0042]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Majower to have an additional sensor located on the shaft, as taught by Beeckler et al., for the purpose of obtaining additional tracking points to dynamically determine the position of the device relative to the patient.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 2007/0208252) in view of Jacobsen et al. (US 2010/0234724).
Regarding claim 6, Makower discloses the invention substantially as claimed, as set forth above for claim 1. Makower further discloses navigation sensor comprises a second navigation sensor that is integrated into a distal end of the shaft assembly (FIG 5, sensor 16 is integrated into the distal end of the shaft).
Makower 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 Majower 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.
Conclusion
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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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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