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 Species I in the reply filed on March 2, 2026 is acknowledged.
Applicant identified Claims 1-4, 16-17, 19-21 & 25 as the claims corresponding to elected Species I. While Claims 1-4, 16 & 20-21 correspond to Species I, Claims 17, 19 & 25 are drawn to non-elected species, as detailed below. As such, Claims 17, 19 & 25 are considered withdrawn in addition to non-elected Claims 5-15, 18 & 22-24 identified by Applicant.
Regarding Claim 17, Claim 17 recites the limitation “wherein the hub includes one or more attachment features configured to removably secure the hub to the accessory attachment portion of the endoscope”. While the accessory attachment portion 118 of the endoscope 100 are disclosed in Species I (see Paras. [0040], [0043] & [0050]), the one or more attachment features 354 of the hub 310 are only disclosed in Species II (see Paras. [0069] & [0070]). As such, Claim 17 is drawn to the non-elected Species II.
Regarding Claims 19, Claim 19 recites, inter alia, “a suction port extending from the hub”. The suction port 618 extending from the hub 612, however, is only disclosed in Species V (see Paras. [0115], [0119] & [0120]). As such, Claim 19 is drawn to the non-elected Species V.
Regarding Claim 25, Claim 25 recites “communicating suction between the cleaning sleeve and the shaft of the endoscope”. This limitation, however, is only disclosed in Species III & V (see Paras. [0079] and [0086] & [0119] and [0120], respectively). As such, Claim 25 is drawn to the non-elected Species II & V.
Disposition of Claims
Claims 1-25 are pending.
Claims 1-4, 16 & 20-21 are rejected.
Claims 5-15, 17-19 & 22-25 are withdrawn.
Claim Objections
Claim 16 is objected to because of the following informality:
Regarding Claim 16, Claim 16 recites the limitation “each navigation sensor being configured to generate signals indicating apposition of one or more features [emphasis added]” on Lines 14-15. This appears to be a typographical error and should read “a position”. 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)(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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Houssiere et al. (hereinafter "Houssiere") (US 2025/0000610).
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), wherein 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]).
Regarding Claim 2, Houssiere discloses 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 discloses 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 discloses 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]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 16 & 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Houssiere et al. (hereinafter "Houssiere") (US 2025/0000610) in view of Akui et al. (hereafter "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, and 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, 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 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, 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 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2025/0000337; US 2023/0165452; US 2021/0100445; US 2019/0125176; US 2018/0078119; US 2014/0275787; US 2013/0053643; US 2012/0029279 and U.S. 6,203,493.
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