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 Amendment filed March 13th, 2026 has been entered. Claims 1, 5 and 14 have been amended. Claim 21 has been newly added. Claims 1-6 and 8-21 are now pending in the application, with claims 3-4, 6 withdrawn. The previous 35 U.S.C. 112(b) rejections of claims 1, 5 and 14 are withdrawn in light of Applicant's amendment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 8-20 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.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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) 1-2, 5, 8-10, 13-17, 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suwa (US 20220386855 A1).
Regarding Claim 1, Suwa discloses
An endoscope (endoscope 10, FIG. 1) comprising:
a handle (operation unit 2, FIG. 1) or interface;
an insertion cord (insertion portion 1, FIG. 1) extending distally from the handle or interface (depicted in FIG. 1); and
a fluid pathway system (endoscope tubular connector 30/ 300, FIGS. 1, 7-8) comprising:
a first flow-through part (distal end portion 50, FIG. 7) having a fluid conduit (through-hole 51, FIG. 7) therethrough and comprising a receiver portion (fitting part 52, FIG. 7);
a second flow-through part (tubular portion 40, FIG. 7) having a fluid conduit (through-hole 41, FIG. 7) therethrough and comprising a tubular connector portion (distal end of tubular portion 40, FIG. 7);
a retainer (connection joint 20G, FIG. 7) having an insertion end (fitting part 24, FIG. 7),
a reception end (step side 22, FIG. 7),
a wall (surface of connection joint 20G, FIG. 7) extending between the insertion end and the reception end (depicted in FIG. 7), and
annular sealing protrusions extending radially outward from an outer surface of the
wall (FIGS. 7-8 depict protrusions on outer surface of connection joint),
the insertion end of the retainer being inserted in the receiver portion of the first flow
through part (depicted in FIG. 7), and
the tubular connector portion of the second flow-through part being inserted in the retainer (depicted in FIG. 7),
the retainer being sized and configured to fluidly seal secure the second flow-through part to the first flow-through part without adhesives (depicted in FIGS. 7-8).
Regarding Claim 2, Suwa discloses
The endoscope of claim 1,
wherein the retainer also comprises annular sealing protrusions (plurality of convex portions 23G, FIG. 7) extending radially inward from an inner surface of the wall (depicted in FIGS. 7-8),
a constriction (through-hole 21, FIG. 7) at the insertion end (depicted in FIG. 7), and
a flange (step 22, FIG. 7) at the reception end (depicted in FIG. 7).
Regarding Claim 5, Suwa discloses
The endoscope of claim 1,
wherein the first flow-through part is a suction valve (suction switch 2e, FIG. 1),
wherein the second flow-through part comprises a suction tube (suction tube 11, FIG. 1) fluidly sealed and connected to the receiver portion of the suction valve (FIG. 7, par. 41 disclose endoscope tubular connector is preferably usable for the suction tube, i.e. via tubular portion),
wherein the suction valve further comprises a second receiver portion (proximal portion of suction switch 2e, FIG. 1), and
wherein the endoscope further comprises a vacuum hose connector fluidly connected to the second receiver portion of the suction valve (FIG. 1, par. 23 disclose suction switch provides suction to suction tube, i.e. via an external device which is capable of being connected via a vacuum hose connector).
Regarding Claim 8, Suwa discloses
The endoscope of claim 1,
wherein the first flow-through part is a Y-connector (par. 37-38 disclose distal end portion forms the treatment tool channel 2d, which is a Y-shaped connector as depicted in FIG. 1), and
the second flow-through part is a suction tube (suction tube 11, FIG. 1; par. 41 discloses endoscope tubular connector is preferably usable for the suction tube).
Regarding Claim 9, Suwa discloses
The endoscope of claim 1,
wherein the first flow-through part is a suction valve (suction switch 2e, FIG. 1), and
the second flow-through part is a suction tube (suction tube 11, FIG. 1) and/or
a vacuum hose fitting.
Regarding Claim 10, Suwa discloses
The endoscope of claim 1, wherein the retainer also comprises annular sealing protrusions (plurality of convex portions 23G, FIG. 7) extending radially inward from an inner surface of the wall (depicted in FIGS. 7-8).
Regarding Claim 13, Suwa discloses
The endoscope of claim 1,
wherein the retainer comprises a flange (step 22, FIG. 7) at the receiver end thereof (depicted in FIG. 7).
Regarding Claim 14, Suwa discloses
The endoscope of claim 1,
wherein the retainer comprises an inner space (through-hole 21, FIG. 7) and
a lead-in zone (step 22, FIG. 7) to the inner space at the receiver end (depicted in FIG. 7).
Regarding Claim 15, Suwa discloses
The endoscope of claim 1, wherein the retainer comprises a constriction (through-hole 21, FIG. 7) at the insertion end thereof (depicted in FIG. 7).
Regarding Claim 16, Suwa discloses
The endoscope of claim 15, wherein an inner interface between the first flow-through part, the second flow-through part and the retainer constriction are configured to provide a consistent inner diameter (depicted in FIGS. 7-8).
Regarding Claim 17, Suwa discloses
The endoscope of claim 1,
wherein the retainer has a ratio of length to outer diameter in a range of 6:5 to 7:5 (FIGS. 7-8 depict connection joint clearly having a higher bias to length than outer diameter, since the outer diameter is varied throughout its length, therefore it is consistent with a 6:5 to 7:5 ratio).
Regarding Claim 21, Suwa discloses
The endoscope of claim 1, wherein the receiver portion of the first flow-through part overlaps the wall of the retainer and the tubular connector portion of the second flow- through part (depicted in FIG. 7).
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) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suwa (US 20220386855 A1) as applied to claim 1 above, and further in view of Hassidov et al. (US 20160324412 A1, hereinafter Hassidov).
Regarding Claim 11, Suwa discloses all of the elements of the current invention disclosed in claim 1, however, Suwa does not disclose wherein the retainer is made of a material having a hardness in an interval of 10-100 Shore A.
Hassidov teaches an analogous system having a colonoscope (i.e., second flow through part) that makes a connection with a sleeve assembly (100). The colonoscope has a connection established with add- on tubes (i.e. first flow through part), which are connected to vacuum and/or irrigation sources [0104], via a housing (30, i.e. retainer) of the sleeve assembly [0212]. The retainer is formed of a flexible material (i.e. elastic resin) having a shore hardness value between 40-90, such as 50 or 70 [0165].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the retainer of Suwa with the flexible material of Hassidov in order to provide a retainer device with versatility in its design and capabilities since adding features such as inflatable balloons to expand the retainer will be easily doable given the elasticity of the retainer, moreover, the flexible retainer will have a lower potential to damage tissues in the body as well as damage connections between the respective flow through parts [Hassidov - 0165].
Regarding Claim 12, Suwa, as previously modified by Hassidov, discloses all of the elements of the current invention disclosed in claim 11, and Hassidov further teaches
The endoscope of claim 11, wherein the hardness is in an interval of 50-70 Shore A (par. 165 discloses housing is formed of a flexible material having a shore hardness value between 40-90, such as 50 or 70).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suwa (US 20220386855 A1) as applied to claim 1 above, and further in view of Avitsian et al (US 20230320575 A1, hereinafter Avitsian).
Regarding Claim 18, Suwa discloses all of the elements of the current invention disclosed in claim 1, and Suwa further discloses wherein the retainer is molded in one piece (depicted in FIGS. 7-8).
However, Suwa does not disclose from an elastic material.
Avitsian teaches an analogous endoscope (12, FIG. 2A) having a handle (22, FIG. 2A, i.e. second flow-through part) combined with an elongate scope portion which provides a lumen to provide a pathway for suctioning a patient (i.e. suction tube) [0028]. The endoscope is connected to an elongate tubular body (30, i.e. first flow-through port), which includes a suction lumen (50) in fluid communication with a suction port (96, i.e. valve), via a sheath assembly (10, FIG. 7, i.e. retainer) [0041]. The retainer (10) can be entirely made of silicone, an elastomer, which provides flexibility [0029].
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the retainer of Suwa with the silicone material of Avitsian in order to provide a retainer structure that will readily bend and flex along with the endoscope during use and allow the retainer assembly to form-fit/ adapt to the requirements of the system [Avitsian – 0029, 0031, 0040].
Regarding Claim 19, Suwa discloses all of the elements of the current invention disclosed in claim 1, and Suwa further discloses wherein the retainer is molded in one piece (depicted in FIGS. 7-8).
However, Suwa does not disclose from a medical grade silicone.
Avitsian teaches an analogous endoscope (12, FIG. 2A) having a handle (22, FIG. 2A, i.e. second flow-through part) combined with an elongate scope portion which provides a lumen to provide a pathway for suctioning a patient (i.e. suction tube) [0028]. The endoscope is connected to an elongate tubular body (30, i.e. first flow-through port), which includes a suction lumen (50) in fluid communication with a suction port (96, i.e. valve), via a sheath assembly (10, FIG. 7, i.e. retainer) [0041]. The retainer (10) can be entirely made of silicone, an elastomer, which provides flexibility [0029].
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the retainer of Suwa with the silicone material of Avitsian in order to provide a retainer structure that will readily bend and flex along with the endoscope during use and allow the retainer assembly to form-fit/ adapt to the requirements of the system [Avitsian – 0029, 0031, 0040].
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suwa (US 20220386855 A1) as applied to claim 1 above, and further in view of Toyoda (US 20150216393 A1).
Regarding Claim 20, Suwa discloses all of the elements of the current invention disclosed in claim 1, and Suwa further discloses a visualization system (endoscope system 10, FIG. 1) comprising: the endoscope of claim 1 (see claim 1 rejection above).
However, Suwa does not disclose a monitor connectable to the endoscope.
Toyoda teaches an analogous endoscope system (2, FIG. 1, i.e. visualization system) with an endoscope (electronic endoscope apparatus 10, FIG. 1) comprising a handle (control handle 17, FIG. 1), an insertion cord (elongated tube 16, FIG. 1) and a fluid pathway system (suction button unit 24, FIG. 7). The endoscope further comprising a universal cord (universal cable 18, FIG. 1) which is capable of providing external connections to the endoscope, specifically processing apparatus (11, FIG. 1) which connects monitor display panel (21, FIG. 1).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the system of Suwa with the monitor of Toyoda in order to provide an external connection to the system which the user/operator can interact with to view images captured by the endoscope [Toyoda – 0042, 0078].
Additionally, the endoscope (10) of Toyoda connects to the monitor (21) via universal cord (3); the endoscope (10) of Suwa also features a universal cord (3, FIG. 1), therefore, the modification would be simple and obvious.
Conclusion
THIS ACTION IS MADE FINAL. 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 ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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