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 Claims 1-6 and 8-21 are now pending in the application, with claims 3-4, 6 withdrawn. The previous 35 U.S.C. 112(b) rejections of claims 1, 5 and 14 are withdrawn in light of Applicant's amendment.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 filed 03/13/2026 have been fully considered but they are not persuasive.
In response to arguments that Kunuki (US 20230320575 A1) does not disclose the tubular connector portion of the second flow-through part being inserted in the retainer, examiner respectfully disagrees. As detailed below, the claim language requires the tubular connection portion to be inserted in the retainer, which can be interpreted as being inserted in any fashion, such as the internal structure or the components which are inserted via the suction pipe line being inserted into any portion of the retainer, par. 55 further discloses that connecting pipe line is formed between the suction pipe line and insertion pipe line, i.e. via the retainer, therefore, connecting member and suction pipe line have a relation requiring insertion between them. Moreover, the claim language can be interpreted as requiring insertion of any part of the tubular connector portion to any part of the retainer, i.e. not insertion into the reception end specifically, therefore, since a connection is formed between the internal channels of the suction pipe line and the internal space of the body part via the retainer [0056], the channel/conduit and/or internal components of the insertion pipe line must be inserted within an internal channel of the retainer, i.e. via the lower end part, to make the connection possible, as depicted in FIG. 9. Moreover, claim language can be interpreted as requiring insertion of any part of the tubular connector portion within the retainer, as the claim language recites “inserted in the retainer,” so the internal channel/conduit and/or components of the suction pipe line would be inserted within the retainer to allow for a connection between the suction pipe line and the internal space of the body part, as well as, to allow for a connecting pipe line to be connected between the insertion pipe line and the suction pipe line [0055-0056]. Therefore, the examiner is maintaining the interpretation that the tubular connector portion (32) of the second-flow through part (30) is inserted in the retainer, however, the examiner has provided additional clarification to the rejection below.
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, 5, 8-9, 13-18, 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kunuki (US 20230320575 A1).
Regarding Claim 1, Kunuki discloses
An endoscope (1, FIG. 1) comprising:
a handle (operating device 2) or interface;
an insertion cord (insertion part 1A) extending distally from the handle or interface (depicted in FIG. 1); and
a fluid pathway system (suction unit 10, FIG. 1) comprising:
a first flow-through part (insertion part 1A + branching member 50, FIG. 10) having a fluid conduit therethrough (insertion pipe line 20, par. 32 discloses insertion pipe line extends through insertion part and branching member, depicted in FIG. 9) and comprising a receiver portion (branching member 50);
a second flow-through part (suction pipe line 30) having a fluid conduit (par. 40 discloses suction pipe line is tube, i.e. conduit in center, depicted in FIG. 9) therethrough and comprising a tubular connector portion (lower end part 32, FIG. 5; par. 40 discloses suction pipe line is tubular, par. 51 discloses lower end part is a connecting part);
a retainer (connecting member 60) having an insertion end (side of guide portion 62), a reception end (side of connection portion 61), a wall extending between the insertion end and the reception end (depicted in FIG. 10), and
annular sealing protrusions (tubular connection portion 61 + guide portion 62) extending
radially outward from an outer surface of the wall (depicted in FIG. 10),
the insertion end of the retainer being inserted in the receiver portion of the first flow
through part (par. 56 discloses guide portion inserted into fitting opening of branching member), and
the tubular connector portion of the second flow-through part being inserted in the retainer (par. 51 discloses lower end part of suction pipe line is connected to connecting member; par. 55 discloses connecting pipe line is formed between the suction pipe line and insertion pipe line, i.e. via the connection between retainer and lower end part; FIG. 9, par. 56 discloses connection between internal channels of the suction pipe line and the internal space of the body part via the retainer, i.e. the channel/conduit and/or internal components of the insertion pipe line must be inserted within an internal channel of the retainer, i.e. via the lower end part),
the retainer being sized and configured to fluidly seal secure the second flow-through part to the first flow-through part without adhesives (par. 55 discloses connection is made between insertion pipe line and suction pipe line via fitting opening, i.e. via connecting member).
Regarding Claim 5, Kunuki discloses
The endoscope of claim 1, wherein the first flow-through part is a suction valve (suction unit 10, par. 69 discloses suction unit and insertion part are connected; par. 76 discloses combination of suction nozzle and introduction pipe line, par. 55 discloses treatment tool introduction opening through which treatment tool can be inserted, i.e. treatment tool opening would be capable of accepting suction unit, FIG. 5),
wherein the second flow-through part comprises a suction tube fluidly sealed and connected to the receiver portion of the suction valve (par. 51 discloses suction pipe line is connected to connection portion provided in the branching member, par. 40 discloses suction pipe line that is formed of a flexible tube),
wherein the suction valve further comprises a second receiver portion (introduction pipe line 40), and
wherein the endoscope further comprises a vacuum hose connector fluidly connected to the second receiver portion of the suction valve (par. 55 discloses treatment tool introduction opening through which treatment tool can be inserted, i.e. treatment tool opening would be capable of accepting a vacuum hose connector used as a treatment tool, FIG. 2).
Regarding Claim 8, Kunuki discloses
The endoscope of claim 1, wherein the first flow-through part is a Y-connector (depicted in FIG. 10), and the second flow-through part is a suction tube (par. 40 discloses suction pipe line is a flexible tube).
Regarding Claim 9, Kunuki discloses
The endoscope of claim 1, wherein the first flow-through part is a suction valve, and the second flow-through part is a suction tube (suction unit 10, par. 69 discloses suction unit and insertion part are connected; par. 76 discloses combination of suction nozzle and introduction pipe line, par. 55 discloses treatment tool introduction opening through which treatment tool can be inserted, i.e. treatment tool opening would be capable of accepting suction unit, FIG. 5) and/or a vacuum hose fitting (par. 40 discloses suction pipe line is a flexible tube).
Regarding Claim 13, Kunuki discloses
The endoscope of claim 1, wherein the retainer comprises a flange at the receiver end (61) thereof (depicted in FIG. 10).
Regarding Claim 14, Kunuki discloses
The endoscope of claim 1, wherein the retainer comprises an inner space and a lead-in zone to the inner space at the receiver end (FIG. 10 discloses a space/ opening, i.e. zone, in connecting portion, par. 56 discloses connection between inner spaces of body part and suction pipe line, i.e. via inner space of retainer; FIG. 10 depicts guide surface of retainer (62c) which extends inward and which the lead-in space extends towards).
Regarding Claim 15, Kunuki discloses
The endoscope of claim 1, wherein the retainer comprises a constriction (guide surface 62c, FIG. 9-10) at the insertion end thereof.
Regarding Claim 16, Kunuki 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 FIG. 9, par. 56 discloses guide surface meant to maintain shape of pipeline in axial direction, i.e. consistent inner diameter).
Regarding Claim 17, Kunuki 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 (FIG. 10 depicts connecting member clearly having a higher bias to length than outer diameter, since a smaller part of the connecting member is rounded, therefore it is consistent with a 6:5 and/or 7:5 ratio).
Regarding Claim 18, Kunuki discloses
The endoscope of claim 1, wherein the retainer is molded in one piece from an elastic material (depicted in FIG. 1, par. 82 discloses it is preferrable that each component of the operating device, i.e. the connecting member, are made of resin, par. 40 discloses flexibility of operating device parts, i.e. elastic resin).
Regarding Claim 20, Kunuki discloses
A visualization system comprising:
the endoscope (1, FIG. 1) of claim 1; and
a monitor (case 91, par. 30 discloses case incorporating tablet terminal, i.e. monitor) connectable to the endoscope (depicted in FIG. 1).
Regarding Claim 21, Kunuki 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. 9).
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) 2, 10, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunuki (US 20230320575 A1) as applied to claim 1 above, and further in view of Avitsian et al (US 20230320575 A1, hereinafter Avitsian).
Regarding Claim 2, Kunuki discloses all of the elements of the current invention disclosed in claim 1, and Kunuki further discloses
The endoscope of claim 1, wherein the retainer also comprises a constriction at the insertion end (guide surface 62c, FIG. 9-10), and a flange at the reception end (depicted in FIG. 10).
However, Kunuki does not disclose annular sealing protrusions extending radially inward from an inner surface of the wall.
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) includes a connector (82, i.e. wall) which joins the rearward end portion (86, i.e. reception end) to the main body portion (88, i.e. insertion end) [0040-0041, FIG. 6]. Moreover, the wall (82) can include at least one flap (114, i.e. annular sealing protrusion) that make direct contact with the handle (22) of the endoscope (12), these flaps can include flaps (114’, FIG. 6) which are disposed on the inner surface of the connector [0045, FIG. 6].
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 Kunuki with the flaps of Avitsian in order to provide a connection between two different flow-through parts that can be manually released, each of the flaps having ridges that allow for manual and direct manipulation of the flaps, and the shape and/or configuration of the flaps is modifiable, i.e. adjustable to the wall of Kunuki [Avistian - 0045].
Regarding Claim 10, Kunuki discloses all of the elements of the current invention disclosed in claim 1, however, Kunuki does not disclose wherein the retainer also comprises annular sealing protrusions extending radially inward from an inner surface of the wall.
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) includes a connector (82, i.e. wall) which joins the rearward end portion (86, i.e. reception end) to the main body portion (88, i.e. insertion end) [0040-0041, FIG. 6]. Moreover, the wall (82) can include at least one flap (114, i.e. annular sealing protrusion) that make direct contact with the handle (22) of the endoscope (12), these flaps can include flaps (114’, FIG. 6) which are disposed on the inner surface of the connector [0045, FIG. 6].
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 Kunuki with the flaps of Avitsian in order to provide a connection between two different flow-through parts that can be manually released, each of the flaps having ridges that allow for manual and direct manipulation of the flaps, and the shape and/or configuration of the flaps is modifiable, i.e. adjustable to the wall of Kunuki [Avistian - 0045].
Regarding Claim 19, Kunuki discloses all of the elements of the current invention disclosed in claim 1, however, Kunuki does not disclose wherein the retainer is molded in one piece 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 Kunuki with the silicone material of Avitsian in order to provide a retainer structure that is readily bend and flex along with the endoscope during use [Avitsian - 0029], qualities that would be useful in the context of the connecting portion (60) of Kunuki since both the insertion part (1A) and the suction pipe line (30) are flexible tubes that are capable of deforming during use [Kunuki – 0031, 0040], the modification would provide consistency in the design.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunuki (US 20230320575 A1) as applied to claim 1 above, and further in view of Hassidov et al. (US 20160324412 A1, hereinafter Hassidov).
Regarding Claim 11, Kunuki discloses all of the elements of the current invention disclosed in claim 1, however, Kunuki 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 Kunuki 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].
Additionally, the retainer (60) of Kunuki is already composed of a flexible material, being elastic resin (par. 82 discloses it is preferrable that each component of the operating device, i.e. the connecting member, are made of resin, par. 40 discloses flexibility of operating device parts, i.e. elastic resin), and it is well known in the art that elastic resin has a hardness between 50-65 Shore A, which is in a compatible range to the flexible material of Hassidov.
Regarding Claim 12, Kunuki, 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).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights