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
Claims 21-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 28, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) filed September 5, 2024, is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “the connecting member is configured to be able to connect the third opening and the second opening.” According to applicant’s disclosure, third opening appears to be directed to reference numeral 43 [0025] and second opening appears to be directed to reference number 42 [0025]. Based on Applicant’s Fig. 2, it appears that only cylindrical member 40 connects third opening 43 and second opening 42, not the connecting member 50. For the purpose of examination, the examiner will be interpreting “the connecting member” in claim 6 as “the cylindrical member”.
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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Uspenski et al. (US2022/0160213) in view of Torii et al. (WO2010/027109).
Regarding claim 1, Uspenski discloses an expansion unit of an endoscope (Fig. 2: endoscopic device 100), comprising: a distal end member that is configured to be able to be held at a distal end part of the endoscope (attachment sleeve 118 in Fig. 16 and Fig. 2/distal cap 112 in Fig. 4/ Fig.39a-c: latex sleeve 113 [0142-0143]); a first tubular member that extends from the distal end member (Fig. 2: catheter 102 extends from attachment sleeve 118); a cylindrical member that has a first opening, that is connected to a base end part of the first tubular member opposite to a side of the distal end member (y-port 109, analogous to applicant’s cylindrical member [0114], comprising a first opening that is connected to a base end part of the catheter 102 opposite to a side of attachment sleeve 118 as seen in Fig. 2), and a second opening (Fig. 2: second opening of the y-port connects to tube 202); and a connecting member that connects the second opening and a suction unit (connecting member, comprising tubes 202, actuator 204, suction valve 206 and suction connecting part 208, connects the second opening of y-port 109 to suction system 200 and suction unit, not illustrated [0113-0114]).
Uspenski fails to disclose wherein the connecting member connects the second opening to a treatment tool inlet port of the endoscope, however, in the same field of endeavor, Torii teaches a substantially similar expansion unit, comprising: a distal end member that is configured to be able to be held at a distal end part of the endoscope (magnets 23 and 24 are interpreted as the distal end member at the distal end part of the endoscope 11 [page 14, lines 26-27]); a first tubular member that extends from the distal member (insertion section 35 of assisting tool 12 [page 16, line 2-3]); a cylindrical member that has a first opening, that is connected to a base end part of the first tubular member opposite to a side of the distal end member (Figs. 1 & 8: attachment portion 36 comprises a first opening that is coupled to the lumen at the proximal end of the insertion section 35 [page 16, lines 5-7]), and a second opening, further teaching wherein the second opening is connected to a treatment tool inlet port of the endoscope using a connecting member (Figs. 1 & 8: attachment portion 36 is attached to the forceps inlet port 19 of endoscope 11 at a second opening [page 25, lines 13-15]). In view of Torii, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the endoscopic device 100 of Upsenski is connected to a forceps inlet port of an endoscope, as taught by Torii, since both the suction unit of Uspenski and the forceps inlet port of Torii provide suction force, and it is known in the endoscope art to share the suction unit between the lumen within an endoscope and the lumen of an accessory device/assisting tool, as taught by Torii.
Regarding claim 2, Uspenski, modified by Torii, discloses the expansion unit according to claim 1, further teaching wherein the connecting member has a first connecting portion connected to the treatment tool inlet port (Fig. 2: Uspenski teaches wherein the connecting member comprises a suction connection 208, analogous to applicant’s first connecting portion; Figs. 1 & 8: Torii teaches wherein the connecting member is connected to the forceps inlet port 19 of the endoscope 11) and a second tubular member having one end connected to the second opening and other end connected to the first connecting portion (Fig. 2: Uspenski teaches wherein the connecting member comprises tubes 202 having one end connected to the second opening of y-port 109 and the other end connected to connecting part 208 [0113]).
Regarding claim 3, Uspenski, modified by Torii, discloses the expansion unit according to claim 2, further teaching wherein the first connecting portion has a sleeve part connected to the treatment tool inlet port, and the sleeve part is configured to be able to generate a negative pressure in the sleeve part in a case where a suction device connected to the endoscope is operated (Fig. 2: Uspenski teaches wherein the first connecting portion 208 is a sleeve part that would be connected to a suction unit [0113], the sleeve part is configured to generate a negative pressure when the suction unit, not illustrated, is connected; Figs. 1 & 8: Torii teaches wherein the connecting member is connected to the forceps inlet port 19 of the endoscope 11, thus allowing suction to occur in both forceps outlet ports 59, 76, suctioning large volume of dirt, blood and bodily fluid through forceps channels 51,72 of endoscope 11 and assisting tool 12 [page 25, lines 15-25]).
Regarding claim 4, Uspenski, modified by Torii, discloses the expansion unit according to claim 1. Uspenski further discloses wherein the cylindrical member has a third opening leading to at least the first opening among the first opening and the second opening (Fig. 2: y-port 109 comprising a third opening represented by biopsy valve 104 that leads to the first opening at the base end part of catheter 102 [0094-0095]).
Regarding claim 5, Uspenski, modified by Torii, discloses the expansion unit according to claim 4. Uspenski further discloses wherein the cylindrical member has a first hollow portion extending from the first opening to the third opening and a second hollow portion extending from the first hollow portion to the second opening (Annotated Fig. 2 below).
PNG
media_image1.png
358
369
media_image1.png
Greyscale
Regarding claim 6, Uspenski, modified by Torii, discloses the expansion unit according to claim 5. Uspenski further teaches wherein the connecting member is configured to be able to connect the third opening and the second opening (Per the 112b rejection above, the examiner is interpreting connecting member to be cylindrical member; Fig. 2: Uspenski teaches y-port 109 configured to connect biopsy valve 104 and the second opening of y-port 109, which is connected to tube 202)
Regarding claim 7, Uspenski, modified by Torii, discloses the expansion unit according to claim 1. Uspenski discloses wherein the connecting member has a first connecting portion connected to the treatment tool inlet port (Fig. 2: Uspenski discloses the connecting member to comprise suction connecting part 208; Fig. 1 & 8: Torii teaches wherein the first connecting portion of Uspenski would be connected to the forceps inlet port 19 of Torii), a second connecting portion connected to the second opening (Fig. 2: Uspenski discloses connecting member comprising tube 202, which comprises a second connecting portion connected to the second opening of y-port 109; second connecting portion and the second opening are the adjacent ends of tube 202 and y-port 109 that are connected), and a third tubular member having one end connected to the second connecting portion and other end connected to the first connecting portion (Uspenski discloses the connecting member comprising one of more suction tubes 202 having one end connected to the second connecting portion, interpreted as the end of tube 202 that is connected to port 109, and the opposite end connected to the first connecting portion 208)
Regarding claim 8, Uspenski, modified by Torii, discloses the expansion unit according to claim 1. Uspenski further disclose wherein the distal end member has an engagement portion that engages with the distal end part of the endoscope (Annotated Fig. 39a: engagement portion appearing to be the inner lumen of sleeve 113 that receives the distal end part of first channel 101 or endoscope 10), and a pipe line that is disposed radially adjacent to the distal end part and that communicates with the first tubular member in a state in which the engagement portion is engaged with the distal end part (Annotated Fig. 39a: pipe line appearing to the be inner lumen of sleeve 113 that receives the distal end of the catheter 102, disposed radially adjacent to the distal end part of first channel 101 or endoscope 10).
PNG
media_image2.png
400
352
media_image2.png
Greyscale
Regarding claim 9, Uspenski, modified by Torii, discloses the expansion unit according to claim 8. Uspenski further discloses wherein the pipe line includes a pipe line extending part that extends further to a base end side of the endoscope than the engagement portion (portions of sleeve 113 may extend in a proximal direction around either the first channel 101 or/and the catheter 102 [0142-0143]. Additionally or alternatively as shown in Figs. 40a-c, the sleeve 113 may extend in a proximal direction around both the first channel 101 and the catheter 102 [0142-0143], thus, although not illustrated, highly suggests a teaching wherein individual portions of sleeve 113 extend in a proximal direction around the first channel 101 and the catheter 102, examiner has annotated Fig. 39c to explain the interpretation).
PNG
media_image3.png
330
365
media_image3.png
Greyscale
Regarding claim 10, Uspenski, modified by Torii, discloses the expansion unit according to claim 9. Uspenski further discloses wherein the first tubular member is connected to the pipe line extending part (Fig. 39a-c, including Annotated Fig. 39c above, catheter 102 is connected to the pipe line extending part).
Regarding claim 11, Uspenski, modified by Torii, discloses the expansion unit according to claim 10. Uspenski further discloses wherein the distal end member has a distal end member extending part that extends from the engagement portion to the base end side of the endoscope (Annotated Fig. 39c above: distal end member extending part extends from the engagement portion proximally to the base end side of the first channel 101 or endoscope 10).
Regarding claim 12, Uspenski, modified by Torii, discloses expansion unit according to claim 11. Uspenski further discloses wherein a length in an extending direction of the distal end member extending part is equal to or longer than a length in an extending direction of the pipe line extending part (Figs. 39a-c, 40a-c: although not illustrated in the drawings, it is strongly suggested that the individual portions of sleeve 113 extending in the proximal direction around catheter 102 and first channel 101 are equal length, as the drawing of Fig. 40c illustrates the sleeve 113 extending in the proximal direction around catheter 102 and first channel 101 in equal length [0142-0143]).
Regarding claim 13, Uspenski, modified by Torii, discloses the expansion unit according to claim 11. Uspenski further discloses wherein the distal end member extending part is provided adjacent to the endoscope that is engaged with the engagement portion and to the pipe line extending part (Annotated Fig. 39c above: distal end member extending part is adjacent to first channel 101 and is adjacent to the pipe line extending part).
Regarding claim 14, Uspenski, modified by Torii, discloses the expansion unit according to claim 13. Uspenski further discloses wherein the distal end member extending part is provided across a line segment connecting a center of the endoscope and a center of the pipe line extending part in a case of being viewed in an axial direction of the endoscope that is engaged with the engagement portion (Although no specific drawing has been provided by Uspenski illustrating the distal end member being viewed in an axial direction, the examiner to the best of her knowledge formed an illustration that would appear to be the sleeve 113, as shown in Fig. 39c, being viewed in an axial direction, see Figure below; since the portion of sleeve 113 extending proximally after the engagement portion is interpreted as the distal end member extending part, and the distal end member extending part wraps around the entire circumference of the distal end part of the endoscope or first tube 101, the distal end member extending part is provided across a line segment, indicated by the dotted line, connecting the two centers).
PNG
media_image4.png
377
547
media_image4.png
Greyscale
Regarding claim 15, Uspenski, modified by Torii, discloses the expansion unit according to claim 14. Uspenski further discloses wherein the distal end member extending part includes a curved surface along an outer peripheral surface of the distal end part of the endoscope that is engaged with the engagement portion (Fig. 39a-c: inner lumen of the distal end member extending part, which is the portion of sleeve 113 that extends proximally along the outer surface of the first channel 101, is curved).
Regarding claim 16, Uspenski, modified by Torii, discloses the expansion unit according to claim 8. Uspenski further discloses wherein the distal end member has a distal end member extending part that extends from the engagement portion to a base end side of the endoscope (portions of sleeve 113 may extend in a proximal direction around either the first channel 101 or/and the catheter 102 [0142-0143]. Additionally or alternatively as shown in Figs. 40a-c, the sleeve 113 may extend in a proximal direction around both the first channel 101 and the catheter 102 [0142-0143], thus, although not illustrated, highly suggests a teaching wherein individual portions of sleeve 113 extend in a proximal direction around the first channel 101 and the catheter 102, examiner has annotated Fig. 39c to explain the interpretation).
PNG
media_image3.png
330
365
media_image3.png
Greyscale
Regarding claim 17, Uspenski, modified by Torii, discloses the expansion unit according to claim 8. Uspenski further discloses wherein the engagement portion and the pipe line are integrally formed (Fig. 39a-39c: the engagement portion and the pipe line are integrally formed of the sleeve 113, see annotated Fig. 39a below).
PNG
media_image2.png
400
352
media_image2.png
Greyscale
Regarding claim 18, Uspenski, modified by Torii, discloses the expansion unit according to claim 8. Uspenski further discloses wherein the distal end member has a protruding portion that protrudes from the engagement portion toward an imaging direction of the endoscope that is engaged with the engagement portion (Annotated Fig. 39a-c: sleeve 113 appears to comprise a protruding portion that protrudes distally).
PNG
media_image5.png
257
299
media_image5.png
Greyscale
PNG
media_image6.png
285
274
media_image6.png
Greyscale
Regarding claim 19, Uspenski, modified by Torii, discloses the expansion unit according to claim 1. Uspenski further discloses wherein the cylindrical member is configured to be able to engage with a part of an adapter device mounted on an operation part of the endoscope (Fig. 2: band 108 and mounting brace 106 indicates that endoscopic device 100, including y-port 109, can be mounted on the endoscope 10 [0097, 0099-0100]).
Regarding claim 20, Uspenski, modified by Torii, discloses the expansion unit according to claim 1. Uspenski further discloses the expansion unit comprising: a coating member that is configured to be able to coat an insertion part of the endoscope, the distal end member held by the distal end part of the endoscope, and the first tubular member (lubricious coating may be applied to the endoscope 10, catheter 102, and the distal cap 112, similar to sleeve 113, [0158]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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.
/LI-TING SONG/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
09/07/2026
Prosecution Insights