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
Regarding Claim 9, Claim 9 depends from Claim 7 which has been canceled. Given that Claim 9 is currently withdrawn, Claim 9 has not been rejected per MPEP § 608.01(n)(V) for depending on a canceled base claim. Applicant, however, must amend Claim 9 to depend from a non-canceled claim in order to avoid delays if/when Claim 9 is rejoined. Appropriate correction is required.
Disposition of Claims
Claims 1-6, 8-9, 11-17, 19-24 & 26-29 are pending.
Claims 1-4, 16, 20-21 & 26-29 are rejected.
Claims 5-6, 8-9, 11-15, 17, 19 & 22-24 are withdrawn.
Claims 7, 10, 18 & 25 are canceled.
Response to Arguments
Applicant’s arguments, see Page 8, filed June 25, 2026, with respect to the objection to Claim 16 have been fully considered and are persuasive in light of amendments to the claims.
The objection to Claim 16 has been withdrawn.
Applicant’s arguments, see Pages 8-11, filed June 25, 2026, with respect to the rejections under 35 U.S.C. §§ 102 & 103 of Claims 1-4, 16 & 20-21 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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 & 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Houssiere et al. (hereinafter "Houssiere") (US 2025/0000610) in view of Krimsky et al. (hereinafter "Krimsky") (US 2018/0338673).
Regarding Claim 1, Houssiere discloses an apparatus (Fig. 12A, 1230; [0094]) for use with an endoscope (Fig. 12A, 1203; [0094]), comprising:
a hub (Figs. 3 & 12A, 1231 wherein 1231 is 331; [0057] & [0094]), the hub (i) being configured to engage a portion of the endoscope (see Fig. 12A), and (ii) including a fluid port (Fig. 3, 337 wherein 337 is a port; [0057] & [0061]),
a shaft assembly (Fig. 12A, 1232; [0094]) extending from the hub (see Fig. 12A) and defining a hollow interior (Fig. 12C, a shaft interior comprising 1204 and 1233; [0094]), the hollow interior being configured to receive a tubular portion of the endoscope (see Fig. 12C) and communicate fluid within the shaft assembly to an open distal end of the shaft assembly ([0094]), and
one or more navigation sensors (Fig. 12B, 1234a, 1234b and 1234c wherein 1234a-c are position sensors; [0094] & [0096]), at least one of the one or more navigation sensors being disposed proximate the distal end of the shaft assembly (see Fig. 12B), the one or more navigation sensors being configured generate signals indicating a position of at least a portion of the shaft assembly in three-dimensional space ([0096] – [0098]).
Houssiere fails to explicitly disclose wherein the one or more navigation sensors are configured to generate the signals indicating the position of at least the portion of the shaft assembly in three-dimensional with respect to a patient anatomy.
However, Krimsky teaches an apparatus (Fig. 1, a sheath assembly comprising 104 and 106; [0033]) for use with an endoscope (Fig. 1, 108; [0033]), comprising:
a hub (Fig. 1, 104; [0033]), the hub being configured to engage a portion of the endoscope ([0033]),
a shaft assembly (Fig. 1, 106; [0033]) extending from the hub (see Fig. 1) and defining a hollow interior (Fig. 2B, a lumen assembly comprising 122 and 124; [0035]), the hollow interior being configured to receive a tubular portion of the endoscope (Fig. 2B, 114; [0035]), and
one or more navigation sensors (Fig. 2B, 134; [0040]), at least one of the one or more navigation sensors being disposed proximate a distal end of the shaft assembly (see Fig. 2B), the one or more navigation sensors being configured generate signals indicating a position of at least a portion of the shaft assembly in three-dimensional space with respect to a patient anatomy ([0040]).
The advantage of using the one or more navigation sensors disposed on the distal end of the shaft assembly to determine a position of the shaft assembly with respect to the patient anatomy is to navigate the shaft assembly and the endoscope through the patient's anatomy without an additional sensor occupying a working channel of the endoscope (Krimsky; [0040]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the one or more navigation sensors as disclosed by Houssiere, to additionally determine a position of the shaft assembly with respect to the patient anatomy, as taught by Krimsky, to navigate the shaft assembly and the endoscope through the patient's anatomy without an additional sensor occupying a working channel of the endoscope (Krimsky; [0040]).
Regarding Claim 2, Houssiere, as previously modified by Krimsky, teaches the apparatus of Claim 1. Houssiere further discloses wherein the one or more navigation sensors includes a plurality of navigation sensors (Fig. 12B, 1234a, 1234b and 1234c wherein 1234a-c are position sensors; [0094] & [0096]).
Regarding Claim 3, Houssiere, as previously modified by Krimsky, teaches the apparatus of Claim 2. Houssiere further discloses wherein the one or more navigation sensors include a first navigation sensor (Fig. 12B, 1234b; [0094] & [0096]) and a second navigation sensor (Fig. 12B, 1234a; [0094] & [0096]),
the first navigation sensor being disposed on the shaft assembly proximate the distal end (see Fig. 12B), and
the second navigation sensor being disposed on the shaft assembly in a different position relative to the first navigation sensor (see Fig. 12B).
Regarding Claim 4, Houssiere, as previously modified by Krimsky, teaches the apparatus of Claim 1. Houssiere further discloses a flexible circuit (Fig. 12B, 1228 wherein 1228 is flexible; [0094] & [0096]) secured to a portion of the shaft assembly (see Fig. 12B), wherein each navigation sensor of the one or more navigation sensors being in electrical communication with the hub via the flexible circuit ([0094]).
Regarding Claim 26, Houssiere, as previously modified by Krimsky, teaches the apparatus of Claim 1. Houssiere further discloses the hub and the shaft assembly being configured to provide a clearance fit (CD; [0077]) for the received tubular portion of the endoscope ([0077]), and the shaft assembly being configured to communicate fluid exterior to the tubular portion of the endoscope ([0077]).
Regarding Claim 27, Houssiere, as previously modified by Krimsky, teaches the apparatus of Claim 1. Houssiere further discloses the shaft assembly having a first length less than a second length of the tubular portion of the endoscope (see Fig. 12A) such that a window of the endoscope (Fig. 12C, EA; [0037], [0095] & [0100]) is configured to extend distal to the open distal end of the shaft assembly ([0095] & [0101]).
Regarding Claim 28, Houssiere, as previously modified by Krimsky, teaches the apparatus of Claim 1. Houssiere further discloses the one or more navigation sensors being configured to generate signals indicating a position of a window (Fig. 12C, EA; [0037], [0095] & [0100]) of the endoscope ([0095] & [0096]).
Claims 16, 20-21 & 29 are rejected under 35 U.S.C. 103 as being unpatentable over Houssiere et al. (hereinafter "Houssiere") (US 2025/0000610) in view of Krimsky et al. (hereinafter "Krimsky") (US 2018/0338673) and Akui et al. (hereinafter "Akui") (US 2006/0199998).
Regarding Claim 16, Houssiere discloses an assembly (Fig. 12A, 1200; [0094]), the assembly comprising:
an endoscope (Fig. 12A, 1203; [0094]), the endoscope including a shaft ([0095]), the shaft including a window (Fig. 12C, EA; [0037], [0095] & [0100]) proximate a distal end of the shaft (see Fig. 12C), and
a cleaning sleeve (Fig. 12A, 1230; [0094]), the cleaning sleeve including:
(i) a hub (Figs. 3 & 12A, 1231 wherein 1231 is 331; [0057] & [0094]) configured to receive a portion of the shaft of the endoscope (see Fig. 12A), the hub including a body (see Figs. 3 & 12A) and a fluid port (Fig. 3, 337 wherein 337 is a port; [0057] & [0061]) extending from the body (see Fig. 3),
(ii) a shaft assembly (Fig. 12A, 1232; [0094]) extending distally from the hub (see Fig. 12A), the shaft assembly including a sleeve (see Fig. 12C) configured to receive the shaft of the endoscope (see Fig. 12C) within a hollow interior defined by the sleeve (Fig. 12C, a shaft interior comprising 1204 and 1233; [0094]), the shaft assembly being configured to define a fluid path between an inner surface of the sleeve and an outer surface of the shaft of the endoscope ([0094]), the fluid path being in communication with the fluid port of the hub to communicate fluid onto the window of the endoscope from an open distal end of the sleeve ([0094]), and
(iii) one or more navigation sensors (Fig. 12B, 1234a, 1234b and 1234c wherein 1234a-c are position sensors; [0094] & [0096]) secured to a portion of the cleaning sleeve (see Fig. 12B), each navigation sensor being configured to generate signals indicating apposition of one or more features of the cleaning sleeve in three-dimensional space ([0096] – [0098]).
The intended use language “for use in an ENT procedure” does not positively recite any structural limitations so as to carry out the function, accordingly the prior art Houssiere can carry out the function, i.e. the intended use recited absent any specific structure recited to do so.
Houssiere fails to explicitly disclose wherein the endoscope includes a body, wherein the shaft extends from the body, wherein the body defines an accessory attachment portion proximate a portion of the shaft; and each navigation sensor being configured to generate the signals indicating the position of one or more features of the cleaning sleeve in three-dimensional space with respect to a patient anatomy.
However, Krimsky teaches an assembly, the assembly (Fig. 1, 100; [0033]) comprising:
an endoscope (Fig. 1, 108; [0033]), the endoscope including a shaft (see Fig. 2B), the shaft including a window (Fig. 2B, 126; [0035]) proximate a distal end of the shaft (Fig. 2B, 114; [0035]), and
a sleeve (Fig. 1, a sheath assembly comprising 104 and 106; [0033]), the sleeve including: (i) a hub (Fig. 1, 104; [0033]), (ii) a shaft assembly (Fig. 1, 106; [0033]) extending distally from the hub (see Fig. 1), the shaft assembly including a sleeve (Fig. 2B, a body of 106; [0035]) configured to receive the shaft of the endoscope within a hollow interior defined by the sleeve (Fig. 2B, a lumen assembly comprising 122 and 124; [0035]), and (iii) one or more navigation sensors (Fig. 2B, 134; [0040]) secured to a portion of the sleeve (see Fig. 2B), each navigation sensor being configured to generate signals indicating a position of one or more features of the sleeve in three-dimensional space with respect to a patient anatomy ([0040]).
The advantage of using the one or more navigation sensors disposed on the distal end of the sleeve to determine a position of the sleeve with respect to the patient anatomy is to navigate the sleeve and the endoscope through the patient's anatomy without an additional sensor occupying a working channel of the endoscope (Krimsky; [0040]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the one or more navigation sensors as disclosed by Houssiere, to additionally determine a position of the sleeve with respect to the patient anatomy, as taught by Krimsky, to navigate the sleeve and the endoscope through the patient's anatomy without an additional sensor occupying a working channel of the endoscope (Krimsky; [0040]).
Houssiere, as previously modified by Krimsky, fails to explicitly disclose wherein the endoscope includes a body, wherein the shaft extends from the body, wherein the body defines an accessory attachment portion proximate a portion of the shaft.
However, Akui teaches an assembly (Fig. 1, 1; [0047]), the assembly comprising:
an endoscope (Fig. 1, 2; [0047]), the endoscope including a body (Fig. 1, 2B; [0048]) and a shaft extending from the body (Fig. 1, 2A; [0047]), the body defining an accessory attachment portion (Fig. 1, 5; [0052]) proximate a portion of the shaft (see Fig. 1), the shaft including a window (Fig. 1, 2a; [0059]), and
a cleaning sleeve (Fig. 1, 3; [0047]), the cleaning sleeve including:
(i) a hub (Fig. 1, 3B; [0053]) configured to receive a portion of the shaft of the endoscope ([0054]), the hub including a body (see Fig. 1) and a fluid port (Fig. 1, 3C; [0054]) extending from the body (see Fig. 1), and
(ii) a shaft assembly (Fig. 1, 3A; [0052]) extending distally from the hub (see Fig. 1), the shaft assembly including a sleeve (see Fig. 1) configured to receive the shaft of the endoscope ([0055]) within a hollow interior defined by the sleeve (Fig. 1, 3c; [0053]), the shaft assembly being configured to define a fluid path (Fig. 1, 3d; [0061]) between an inner surface of the sleeve and an outer surface of the shaft of the endoscope ([0061] & [0062]), the fluid path being in communication with the fluid port of the hub to communicate fluid onto the window of the endoscope from an open distal end of the sleeve ([0064]).
The advantage of the endoscope body with the accessory attachment portion is to reliably connect the endoscope to the cleaning sleeve (Akui; [0052]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the endoscope as disclosed by Houssiere, as previously modified by Krimsky, to include the endoscope body with the accessory attachment portion taught by Akui, to reliably connect the endoscope to the cleaning sleeve (Akui; [0052]).
Regarding Claim 20, Houssiere discloses a method (Figs. 13A & 13B, 1300 & 1350; [0124] & [0129]) of using an endoscope (Fig. 12A, 1203; [0094]) with a cleaning sleeve (Fig. 12A, 1230; [0094]), the method comprising:
inserting (Fig. 13A, 1314; [0128]) a shaft of the endoscope ([0095]) into the cleaning sleeve ([0128]) to align an open distal end of the cleaning sleeve (see Fig. 12A) with a window of the shaft of the endoscope (Fig. 12C, EA; [0037], [0095] & [0100]),
providing a hub of the cleaning sleeve (Fig. 12A, 1231; [0094]),
locating (Fig. 13B, 1358; [0131]) the open distal end of the cleaning sleeve in three-dimensional space to navigate the window of the endoscope ([0131]) using one or more navigation sensors coupled to the cleaning sleeve (Fig. 12B, 1234a, 1234b and 1234c wherein 1234a-c are position sensors; [0094] & [0096]), and
communicating (Fig. 13B, 1360; [0132]) a fluid between the cleaning sleeve and the shaft of the endoscope and out of the open distal end to clean at least a portion of the window of the endoscope ([0096]).
Houssiere fails to explicitly disclose locating the open distal end of the cleaning sleeve in three-dimensional space with respect to a patient anatomy to navigate the window of the endoscope using the one or more navigation sensors coupled to the cleaning sleeve; and coupling the hub of the cleaning sleeve to at least a portion of the endoscope to removably secure the cleaning sleeve to the endoscope.
However, Krimsky teaches a method ([0034]) of using an endoscope (Fig. 1, 108; [0033]) with a sleeve (Fig. 1, a sheath assembly comprising 104 and 106; [0033]), the method comprising:
inserting ([0034]) a shaft of the endoscope (Fig. 2B, 114; [0035]) into the sleeve to align an open distal end of the sleeve (Fig. 2B, 118; [0035]) with a window of the shaft of the endoscope (Fig. 2B, 126; [0035]), and
locating the open distal end of the sleeve in three-dimensional space with respect to a patient anatomy ([0040]) to navigate the window of the endoscope ([0040]) using one or more navigation sensors (Fig. 2B, 134; [0040]) coupled to the sleeve (see Fig. 2B).
The advantage of using the one or more navigation sensors disposed on the open distal end of the sleeve to locate the open distal end of the sleeve in three-dimensional space with respect to a patient anatomy is to navigate the sleeve and the endoscope through the patient's anatomy without an additional sensor occupying a working channel of the endoscope (Krimsky; [0040]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the one or more navigation sensors as disclosed by Houssiere, to additionally locate the open distal end of the sleeve in three-dimensional space with respect to a patient anatomy, as taught by Krimsky, to navigate the sleeve and the endoscope through the patient's anatomy without an additional sensor occupying a working channel of the endoscope (Krimsky; [0040]).
Houssiere, as previously modified by Krimsky, fails to explicitly disclose coupling the hub of the cleaning sleeve to at least a portion of the endoscope to removably secure the cleaning sleeve to the endoscope.
However, Akui teaches a method ([0112]) of using an endoscope (Fig. 1, 2; [0047]) with a cleaning sleeve (Fig. 1, 3; [0047]), the method comprising:
inserting ([0113]) a shaft of the endoscope (Fig. 1, 2A; [0047]) into the cleaning sleeve ([0113]), and
coupling ([0114]) a hub of the cleaning sleeve (Fig. 1, 3B; [0053]) to at least a portion of the endoscope (Fig. 1, 5; [0052]) to removably secure the cleaning sleeve to the endoscope ([0114]).
The advantage of the using the accessory attachment portion to couple the hub of the cleaning sheath to the endoscope is to reliably connect the endoscope to the cleaning sleeve (Akui; [0052]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the method as disclosed by Houssiere, as previously modified by Krimsky, to include the step of using the accessory attachment portion to couple the hub of the cleaning sheath to the endoscope taught by Akui, to reliably connect the endoscope to the cleaning sleeve (Akui; [0052]).
Regarding Claim 21, Houssiere, as previously modified by Krimsky and Akui, teaches the method of Claim 20. Houssiere further discloses locating at least one other feature of the cleaning sleeve in three-dimensional space to navigate one or more elements of the endoscope using the one or more navigation sensors ([0096]).
Regarding Claim 29, Houssiere, as previously modified by Krimsky and Akui, teaches the method of Claim 20. Krimsky further teaches navigating the window of the endoscope through one or more anatomical passageways using the one or more navigation sensors ([0040]).
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 STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL CAREY can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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